DRS/A

As confidentially submitted to the Securities and Exchange Commission on April 13, 2018. This draft registration statement has not been publicly filed with the Securities and Exchange Commission and all information herein remains strictly confidential.

Registration No. 333-                

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

Confidential Submission No. 2

on

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

MeiraGTx Holdings plc1

(Exact name of registrant as specified in its charter)

 

 

 

England and Wales   2836   Not applicable

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification No.)

430 East 29th Street, 10th Floor

New York, NY 10016

(646) 490-2965

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Alexandria Forbes, Ph.D.

President and Chief Executive Officer

MeiraGTx Holdings plc

430 East 29th Street, 10th Floor

New York, NY 10016

(646) 490-2965

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

Peter N. Handrinos

Keith Halverstam

Latham & Watkins LLP

200 Clarendon Street

Boston, Massachusetts 02116

+617 948 6000

 

Claire A. Keast-Butler

Latham & Watkins LLP

99 Bishopsgate

London EC2M 3XF

United Kingdom

+44 20 7710 1000

 

Ed Lukins

Ed Dyson

Cooley (UK) LLP

Dashwood

69 Old Broad Street

London EC2M 1QS

United Kingdom

+44 20 7785 9355

  

Brent B. Siler

Divakar Gupta

Richard C. Segal

Cooley LLP

1114 Avenue of the Americas

New York, NY 10036

+212 479 6000

 

 

Approximate date of commencement of proposed sale to the public:

As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.    ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer      Accelerated filer  
Non-accelerated filer     (Do not check if a smaller reporting company)    Smaller reporting company  
     Emerging growth company  

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. 

 

 

CALCULATION OF REGISTRATION FEE

 

 

Title of Each Class of

Securities To Be Registered

  Proposed
Maximum
Aggregate
Offering Price(1)(2)
  Amount of
Registration Fee(3)

Ordinary shares,         nominal value per share

  $   $

 

 

 

(1) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.
(2) Includes the aggregate offering price of additional shares that the underwriters have the option to purchase.
(3) Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.

 

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

1  Prior to the completion of this offering, we intend to incorporate MeiraGTx Holdings plc, a public limited company under the laws of England and Wales, which will be the direct parent of MeiraGTx Limited and the holding company of the business and will be the issuer of ordinary shares in this offering.


EXPLANATORY NOTE

This filing is being confidentially submitted for the purpose of submitting Exhibits 10.10, 10.11, 10.12, 10.13 and 10.14 to the Registration Statement on Form S-1 (the “Registration Statement”). No change is being made to the prospectus constituting Part I of the Registration Statement or Items 13, 14 or 17 of Part II of the Registration Statement.


Part II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table indicates the expenses to be incurred in connection with the offering described in this registration statement, other than underwriting discounts and commissions, all of which will be paid by us. All amounts are estimated except the Securities and Exchange Commission registration fee, the Financial Industry Regulatory Authority, Inc., or FINRA, filing fee and the Nasdaq listing fee.

 

     Amount  

Securities and Exchange Commission registration fee

   $ *  

FINRA filing fee

     *  

Initial listing fee

     *  

Accountants’ fees and expenses

     *  

Legal fees and expenses

     *  

Blue Sky fees and expenses

     *  

Transfer Agent’s fees and expenses

     *  

Printing and engraving expenses

     *  

Miscellaneous

     *  
  

 

 

 

Total expenses

   $ *  
  

 

 

 

 

* To be filed by amendment.

Item 14. Indemnification of Directors and Officers.

We intend to enter into indemnification agreements with each of our directors and officers. These indemnification agreements may require us, among other things, to indemnify our directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of our directors or officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request.

We maintain a general liability insurance policy that covers certain liabilities of directors and officers of our corporation arising out of claims based on acts or omissions in their capacities as directors or officers.

In any underwriting agreement we enter into in connection with the sale of ordinary shares being registered hereby, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act of 1933, as amended, or the Securities Act, against certain liabilities.

Item 15. Recent Sales of Unregistered Securities.

Set forth below is information regarding shares of capital stock issued by us within the past three years. Also included is the consideration received by us for such shares and information relating to the section of the Securities Act, or rule of the Securities and Exchange Commission, under which exemption from registration was claimed.

 

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(a) Issuance of Capital Stock.

From April 24, 2015 through March 29, 2018, the registrant issued an aggregate 36,389,760 Series A ordinary shares for an aggregate consideration of approximately $8.7 million.

From October 1, 2015 through March 29, 2018, the registrant issued an aggregate 36,423,285 Series C preferred shares for an aggregate consideration of approximately $97.9 million to investors.    

(b) Equity Grants.

From March 4, 2016 through January 10, 2018, the registrant granted stock options to purchase an aggregate of 6,292,500 Series A ordinary shares with exercise prices ranging between $0.68 and $1.99 per share to employees, non-employee consultants, and directors in connection with services provided to the registrant by such parties.

(c) Warrants.

On September 22, 2017, the registrant issued a warrant to purchase up to an aggregate of 2,700,000 shares of Series C preferred shares to Perceptive Life Sciences Master Fund Ltd pursuant to Section 4(a)(2) of the Securities Act as a transaction not involving a public offering.

On November 2, 2017, the registrant issued a warrant to purchase up to aggregate of 900,000 shares of Series C preferred shares to Alexandria Equities No. 7, LLC pursuant to Section 4(a)(2) of the Securities Act as a transaction not involving a public offering.

(d) Issuance of Notes.

On May 1, 2017, the registrant issued a convertible note to an entity associated with Alexandria Equities No. 7, LLC, in the principal amount of $2.5 million. On November 2, 2017, the convertible note was converted and the registrant issued 925,926 Series C preferred shares to Alexandria Equities No. 7, LLC at $2.70 per share for an aggregate consideration of approximately $2.5 million.

Item 16. Exhibits and Financial Statement Schedules.

(a) Exhibits.

 

Exhibit
Number
  

Description of Exhibit

1.1*    Underwriting Agreement
3.1*    Articles of Association of the Registrant (currently in effect)
3.2*    Form of Restated Articles of Association of the Registrant (to be effective upon the closing of this offering)
4.1*    Specimen Stock Certificate evidencing the ordinary shares of the Registrant
5.1*    Opinion of Latham & Watkins LLP
10.1#*    2016 Equity Incentive Plan, as amended, and form of option agreements thereunder
10.2#*    2018 Incentive Award Plan and form of option agreements thereunder
10.3#*    Non-Employee Director Compensation Program

 

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Exhibit
Number
  

Description of Exhibit

10.4#*    Form of Indemnification Agreement for Directors and Officers
10.5*    Lease Agreement, dated June 29, 2016, as amended, between MeiraGTx Limited and ARE-East River Science Park LLC
10.6*    Lease Agreement, dated February 2, 2016, among MeiraGTx Limited, Moorfields Eye Hospital NHS Foundation Trust and Kadmon Corporation LLC
10.7*    Employment Agreement, dated February 15, 2016, between MeiraGTx Limited and Alexandria Forbes, Ph.D.
10.8*    Employment Agreement, dated February 15, 2016 between MeiraGTx Limited and Richard Giroux
10.9*    Employment Agreement, dated April 27, 2015, between MeiraGTx Limited and Stuart Naylor, Ph.D.
10.10†    License Agreement, dated May 1, 2013, as amended, among MeiraGTx Limited, Brandeis University and BRI-Alzan Inc.
10.11†    License Agreement, dated February 4, 2015, as amended, between Athena Vision Ltd. and UCL Business Plc
10.12†    License Agreement, dated July 28, 2017, as amended, between MeiraGTx UK II Limited and UCL Business Plc
10.13†    License Agreement, dated March 15, 2018, among MeiraGTx Limited, MeiraGTx UK II Limited and UCL Business Plc
10.14†    Agreement and Plan of Merger, dated December 31, 2015, among MeiraGTx Acquisition Corporation, BRI-Alzan Inc., F-Prime Inc., Gregory Petsko, Dagmar Ringe, Brandeis University and MeiraGTx Limited
21.1*    Subsidiaries of the Registrant
23.1*    Consent of Ernst & Young LLP
23.2*    Consent of Latham & Watkins LLP (included in Exhibit 5.1)
24.1*    Power of Attorney (included on signature page)

 

* To be filed by amendment.
# Indicates management contract or compensatory plan.
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment pursuant to Rule 406 under the Securities Act of 1933, as amended.

(b) Financial Statement Schedules.

Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the consolidated financial statements or notes thereto.

Item 17. Undertakings.

The undersigned registrant hereby undertakes to provide to the underwriter, at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is

 

II-3


asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned hereby undertakes that:

 

  (1) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

 

  (2) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

II-4


SIGNATURES

Pursuant to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, New York, on this                day of                 , 2018.

 

MeiraGTx Holdings plc
By:  

 

  Alexandria Forbes, Ph.D.
  President and Chief Executive Officer

SIGNATURES AND POWER OF ATTORNEY

We, the undersigned officers and directors of MeiraGTx Holdings plc., hereby severally constitute and appoint Alexandria Forbes, Ph.D. and         , and each of them singly (with full power to each of them to act alone), our true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution in each of them for him and in his name, place and stead, and in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement (or any other registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933), and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities held on the dates indicated.

 

Signature

  

Title

   Date  

 

Alexandria Forbes, Ph.D.

  

President, Chief Executive Officer and

Director (principal executive officer)

         , 2018  

 

Richard Giroux

  

Chief Operating Officer

(principal financial officer and principal accounting officer) and MeiraGTx Holdings plc’s authorized representative in the United States

         , 2018  

 

Keith R. Harris, Ph.D.

   Chairman of the Board of Directors          , 2018  

 

Ellen Hukkelhoven, Ph.D.

   Director          , 2018  

 

Arnold J. Levine, Ph.D.

   Director          , 2018  

 

Joel S. Marcus

   Director          , 2018  

 

Neil Mendoza

   Director          , 2018  

 

Stuart Naylor, Ph.D.

   Director          , 2018  

 

Thomas E. Shenk

   Director          , 2018  
EX-10.10

Exhibit 10.10

Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENSE AGREEMENT

between

BRANDEIS UNIVERSITY

and

BRI-Alzan Inc.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENSE AGREEMENT

This License Agreement (“Agreement”), effective as of May 1, 2013 (“Effective Date”) between Brandeis University, a not-for-profit corporation duly organized and existing under the laws of The Commonwealth of Massachusetts and having its principal place of business at 415 South Street, Waltham, Massachusetts 02454-9110 (“Brandeis”), and BRI-Alzan Inc., a corporation duly organized and existing under the laws of the State of Delaware and having offices at c/o Fidelity Biosciences Corp., One Main Street, 13th Floor, Cambridge, MA 02142 (hereinafter referred to as “Licensee”).

WHEREAS, Brandeis through research conducted by Dagmar Ringe, Gregory Petsko and Xu Simon (the “Inventors”), has developed an invention pertaining to by Brandeis Case No. 1092 “Protein Therapy for ALS”, for which Brandeis has filed patent applications.

WHEREAS, as a center for research and education, Brandeis desires to license the Patent Rights and thus benefit the public and Brandeis by facilitating the dissemination of the results of its research in the form of useful products. However, Brandeis itself does not have the capacity to commercially develop, manufacture or distribute the Licensed Products, and is therefore willing to grant an exclusive license to the Licensee in the technology.

WHEREAS, Licensee having such capacity, desires to commercially develop, manufacture, use and distribute such Licensed Products.

WHEREAS, Brandeis and Fidelity Biosciences Corp, (as defined herein) have entered into a Research Agreement (as defined herein) and Brandeis and Fidelity Biosciences Corp, have acknowledged that this Agreement is an Alternative Arrangement (as defined in the Research Agreement), which shall be in lieu of and not in addition to the license set forth in the Research Agreement.

NOW THEREFORE, in consideration of the mutual covenants of this Agreement, the parties agree:

1. DEFINITIONS

1.1 “Accounting Period” means each three month period during the term of this Agreement, including partial periods at the beginning and end of the term of this Agreement, ending March 31, June 30, September 30 and December 31.

1.2 “Affiliate” means, with respect to any specified Person, any other Person who, directly or indirectly, Controls, is Controlled by, or is under common Control with such Person, including without limitation any entity that is a general partner or managing member of such Person. The term “Control” of a given Person means possession, direct or indirect, of the power to direct the management or policies of such Person, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise, and the terms “Controlling” and “Controlled” shall have meanings correlative to the foregoing.

1.3 [Reserved]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

1.4 “Change of Control” means transfer of all, or substantially all, of the rights granted in the Agreement to a non-Affiliate assignee, in accordance with Section 10.4, hereunder, or to a Sublicensee in accordance with Section 2.2, hereunder.

1.5 “Fidelity Biosciences” means Fidelity Biosciences Corp. (“FBC”), a Delaware corporation.

1.6 “First Commercial Sale” means the first sale of any Licensed Product by Licensee or its Affiliates or its Sublicensees (each, a “Seller”).

1.7 “Gross Sales” or “Gross Sales Price” means for any arm’s length sale, transfer, dispositions or other dealing to a customer by a Seller, the Gross Sales Price shall be the gross amount invoiced by the Seller for the sale, transfer or other disposition of or dealing with a Licensed Product.

Transfer of a Licensed Product within the Licensee or between Licensee, Sublicensee or an Affiliate shall not be considered a sale, commercial use or disposition for the purpose of the foregoing paragraphs; in the case of such transfer the Gross Sales Price shall be based on sale of the Licensed Product by the transferee. If a Seller commercially uses or disposes of any Licensed Product by itself other than in an arm’s length sale to a bona fide customer, the Gross Sales Price hereunder shall be the price which would be then payable in an arm’s length transaction. [***].

For any sale of a Licensed Product to which the United States government is entitled to a royalty-free right pursuant to 35 USC 202(c)(paragraph 4), [***].

1.8 “Know-How” means Brandeis’ rights in discoveries, data (including research, pre-clinical and clinical data), designs, formulas, methods, techniques, materials, technology, results, analyses, and process information (including scientific and technical information) or know-how during the term of this Agreement that are not claimed by the Patent Rights but are, or could reasonably be, necessary for practicing the Patent Rights.

1.9 “License Fields” mean all fields.

1.10 “Licensed Products” mean any composition or method, the practice, development, manufacture, use, offer for sale or sale of which, in whole or in part absent the licenses granted herein, would infringe a Valid Claim of any Patent Right.

1.11 “NDA Filing” means filing a New Drug Application with the USFDA for a Licensed Product.

1.12 “Net Sales” or “Net Sales Price” means the Gross Sales Price received by a Seller less (to the extent appropriately documented) the following amounts actually paid out by a Seller or credited against the amounts received by it from the sale or distribution of Licensed Product:

(a) credits, allowances and price adjustments for damaged Licensed Products or for the rejection or return of Licensed Products previously sold;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

2


Confidential Treatment Requested by MeiraGTx Holdings plc

 

(b) rebates, chargeback payments and trade, cash and quantity discounts to purchasers allowed and taken;

(c) amounts for transportation, insurance, handling or shipping charges directly related to the sale or distribution of Licensed Product and listed on the invoices or purchase order for such Licensed Product; and

(d) taxes, tariffs, duties and other governmental charges levied on or measured by the sale of Licensed Products, whether absorbed by the Seller or paid by the purchaser so long as the Seller’s price is reduced thereby, but not franchise or income taxes of any kind whatsoever.

1.13 “Patent Right” means Brandeis’ rights in patents and patent applications listed in Exhibit B, (the “Applications”), or the equivalent of such Applications, including any division, continuation or any foreign patent application; and any Letters Patent or the foreign equivalent issuing on such applications, and any reexamination or extension thereof. Patent Rights shall also include those claims in any continuation-in-part application that are supported or enabled by the Applications. All of the Inventors’ rights, title and interest in the Applications have been assigned to Brandeis.

1.14 “Person” means any corporation, partnership, trust, or limited liability company, association or other entity.

1.15 “Phase II Initiation” means the first dosing of a human subject, in Phase II (Phase Two) Clinical Trials, with a Licensed Product.

1.16 “Phase III Initiation” means the first dosing of a human subject, in Phase III (Phase Three) Clinical Trials, with a Licensed Product.

1.17 “Research Agreement” means the Research Agreement between Brandeis and Fidelity Biosciences, dated as of December 21, 2011.

1.18 “Research Agreement Term” means the effective term of the Research Agreement.

1.19 “Seller” has the meaning set forth in Section 1.6.

1.20 “Sublicensee” means any non-Affiliate third party licensed by Licensee or an Affiliate in accordance with Section 2.2 to develop, commercialize, make, have made, use, lease, import, sell or offer for sale any Licensed Product.

1.21 “Territory” shall mean world-wide.

1.22 “Valid Claim” means any claim of any Patent Right that has not been (i) finally rejected or (ii) declared invalid by a patent office or court of competent jurisdiction in any unappealed and unappealable decision.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

2. LICENSE

2.1 Grant of License. To the extent not prohibited by the United States Government or by contractual obligations to any other sponsor of research at Brandeis, and expressly subject to Sections 2.3 through 2.6 below as well as the other terms and conditions of this Agreement, Brandeis hereby grants Licensee:

2.1.1 an exclusive, terminable, royalty-bearing license under Patent Rights to develop, commercialize, make, have made, use, lease, import, sell and offer for sale Licensed Products solely in the License Fields in the Territory; and

2.1.2 A non-exclusive, terminable, royalty-free license to use the Know-How, solely to the extent necessary to practice the exclusive rights under Section 2.1.1, above.

All licenses pursuant to this Section 2.1 are subject to the rights, conditions and limitations imposed by U.S. law with respect to inventions made in the performance of federally funded research.

2.2 Right to Sublicense. Brandeis grants to Licensee the right to grant sublicenses in its rights, privileges and license granted to Licensee in Section 2.1, only with the prior written approval of Brandeis, which permission shall not be unreasonably withheld.

2.2.1 Sublicenses granted under this Section shall contain all of the conditions, restrictions and reservations of this Agreement, except for the provisions related to fees and royalties, and must preserve the rights of Brandeis and the U.S. Government existing under this Agreement. Licensee shall promptly provide to Brandeis a copy of any and all fully executed sublicense agreements, and shall provide to Brandeis, within [***] ([***]) days of the end of each Accounting Period, a copy of reports received by Licensee from its Sublicensees for the previous Accounting Period relating to royalty or non-royalty consideration under such sublicense agreements.

2.2.2 [***].

2.2.3 The granting of a sublicense by Licensee shall not operate to relieve Licensee from any of its obligations under this Agreement. Licensee shall be responsible for and remit royalties based upon its Sublicensee’s activities as if said activities were its own.

2.3 Reservation of Rights. Brandeis expressly reserves the right to make, have made and to use and transfer the subject matter described and claimed in the Patent Rights for any noncommercial purpose.

2.4 [***] Manufacturing. Licensee agrees that [***].

2.5 Scope. Nothing herein shall be construed to grant Licensee a license, express or implied, under any intellectual property right owned solely or jointly by Brandeis other than the Patent Rights and Know-How expressly licensed hereunder.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

4


Confidential Treatment Requested by MeiraGTx Holdings plc

 

2.6 Affiliates. Licensee may extend the license granted herein to any Affiliate of Licensee if the Affiliate consents in writing to be bound by this Agreement to the same extent as Licensee. Licensee must deliver to Brandeis a true and accurate copy of such written agreement, and any modification or termination thereof, within [***] days after execution, modification or termination.

2.7 Liability. Notwithstanding any liability that may accrue directly to any Affiliate or Sublicensee hereunder, Licensee shall remain directly liable to Brandeis for any amount due from or liability incurred or accrued by any Sublicensee or Affiliate under this Agreement.

2.8 Representation. Brandeis represents, to the best of its knowledge, that all of the Inventors’ rights, title and interest in the Applications have been assigned to Brandeis. Licensee acknowledges receipt of copies of the patent assignments from Brandeis.

3. DILIGENCE OBLIGATIONS

3.1 Commercialization Milestones. Licensee shall itself, or through its Affiliates or Sublicensees, use commercially reasonable efforts to develop Licensed Products for commercial sales and distribution in the License Fields in the Territory and to continue active, diligent marketing efforts for Licensed Products throughout the life of this Agreement. Such efforts require achieving the following objectives:

(a) During the last [***] ([***]) months of the Research Agreement Term, the parties will meet and mutually agree on due dates for the following milestones. These milestone due dates shall be incorporated into this agreement:

 

Milestone

  

Achievement Due Date (to be added in accordance with this Section 3.1(a)

(i) Phase II Initiation

  

(ii) Phase III Initiation

  

(iii) NDA Filing

  

If Licensee fails to achieve one or more of the above objectives within the above stated periods, Brandeis, in its sole discretion, shall have the right to terminate any exclusive or nonexclusive license granted hereunder in accordance with Section 9.2.1, below.

3.2 Progress Reports. Within [***] ([***]) days of the end of its fiscal year, Licensee shall provide a written report to Brandeis detailing its progress or lack of progress, along with supporting documentation, made toward the foregoing objectives.

3.3 Research Agreement. The parties acknowledge that the Research Agreement was signed December 21, 2011, and that FBC has paid all fees due under the Research Agreement to date.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

4. PAYMENTS AND REPORTS

4.1 Fees and Royalties. In consideration for the rights, privileges and license granted under this Agreement, Licensee shall pay to Brandeis the fees, equity and royalties set forth in Exhibit A. In each year the amount of royalty and sublicense fees due shall be calculated quarterly as of the end of each Accounting Period and shall be paid within [***] ([***]) days following the end of such Accounting Period.

4.2 Late Payments. If any payment due under this Agreement is not paid within [***] ([***]) days of the date upon which such payment is due, then interest shall accrue on such payment on a daily basis from the date such payment was originally due at a rate equal to [***] ([***]) month LIBOR (as published in The Wall Street Journal, New York edition) plus [***] percent ([***]%) per annum, calculated daily, or at the maximum rate permitted by law, whichever is the lower, and such interest shall be paid when such payment is made. The payment of such interest shall not preclude the party receiving such interest from exercising any other rights it may have as a consequence of the lateness of any payment.

4.3 Conversion. All amounts payable by Licensee must be paid in United States dollars without deductions for taxes, assessments, fees, or charges of any kind. Royalties accruing on sales in countries other than the United States must be paid in United States dollars in amounts based on the rate of exchange as quoted in the Wall Street Journal (WSJ) as of the last business day of the reporting period. If the WSJ does not publish any such rate, a comparable rate publication will be agreed upon from time to time by the parties, and with respect to each country for which such rate is not published by the WSJ or in a comparable publication, the parties will use the prevailing rate for bank cable transfers for such date, as quoted by leading United States banks in Boston dealing in the foreign exchange market.

4.4 Records. Licensee shall keep complete and accurate records of its, and its Affiliates and Sublicensees’ Net Sales under the license granted in this Agreement in sufficient detail to enable the royalties payable hereunder to be determined. Such records shall be retained for at least [***] ([***]) years following the end of the Accounting Period to which such records relate. Licensee agrees to permit Brandeis or its representatives, at Brandeis’ expense and with [***] days written notice, to periodically examine its books, ledgers, and records during regular business hours for the purpose of and to the extent necessary to verify any report and payment required under this Agreement. If the amounts due to Brandeis are determined to have been underpaid, by [***] percent ([***]%) or more, Licensee will pay the cost of the examination and all overdue amounts with accrued interest in accordance with Section 4.2.

4.5 Royalty Reports. Whether or not a payment is due, Licensee shall deliver to Brandeis a full and accurate reporting and accounting, certified as such by an officer of Licensee, as well as supporting documents as required by Sections 2.2, 2.6 and 3.2 and this Section 4.5 regarding any royalties or other consideration, and shall include at least the following information for the preceding Accounting Period within [***] ([***]) days of the end of the preceding Accounting Period:

4.5.1 Quantity of each Licensed Product sold (by country) by the Sellers;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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4.5.2 Total billings for each Licensed Product (by country);

4.5.3 Quantities of each Licensed Product used by Licensee and its Affiliates or Sublicensees;

4.5.4 An accounting of all deductions applicable to determine the Net Sales;

4.5.5 Names and addresses of all Sublicensees and Affiliates subject to Section 2.6 of Licensee; and

4.5.6 Total royalties payable to Brandeis.

4.6 Annual Reports. Licensee shall deliver to Brandeis a copy of its financial statements, certified by an officer of Licensee, and evidence or renewal of insurance in accordance with Section 7.2, below, within [***] ([***]) days of the end of its fiscal year. Licensee shall deliver to Brandeis its annual reports to stock holders and material revisions to its business plan when prepared.

4.7 Delivery. All payments and reports due Brandeis shall be made payable to Brandeis University, shall include documentation as described in this Section 4 and reference to Brandeis Reference # 1092, and delivered to:

Director, Office of Technology Licensing

Brandeis University, MS115

415 South Street

Waltham, MA 02454-9110

5. FILING, PROSECUTION AND MAINTENANCE OF PATIENT RIGHT

5.1 Responsibility; Costs. Brandeis shall be responsible for the searching, preparation, filing, prosecution and maintenance of all patent applications and patents included in Patent Rights. Brandeis retains the right to select the attorney responsible for the prosecution and maintenance of the Patent Rights and to present such attorney to Licensee for Licensee’s approval which shall not be unreasonably withheld or delayed. The attorney responsible for the prosecution and maintenance of the Patent Rights shall be retained by mutual agreement of Brandeis and Licensee. Brandeis or its attorneys shall consult with Licensee with respect to all proposed actions and filings described in this Section 5.1 and shall provide Licensee with reasonable opportunities to advise Brandeis concerning the same. Licensee shall take reasonable actions to cooperate with Brandeis in such filing, prosecution and maintenance. Licensee shall reimburse Brandeis for all reasonable costs incurred by Brandeis for the preparation, filing, prosecution and maintenance of all Patent Rights (“Costs”) as follows:

5.1.1 Subject to paragraph 5.1, above, for all Costs incurred by Brandeis prior to and after the Effective Date, Licensee shall reimburse Brandeis within [***] ([***]) days of receipt of invoices from Brandeis. Brandeis shall prepare, file, prosecute, and maintain all of the licensed Patent Rights. Brandeis and its appointed patent attorneys will [***] copy Licensee on all patent correspondence as follows: (a) documents received from any patent office shall be provided to Licensee promptly after receipt; (b) any document to be filed in any patent office

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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shall be provided in draft form to Licensee sufficiently prior to such document’s filing to allow for review and comment by Licensee; and (c) documents filed with any patent office shall be provided to Licensee promptly after filing. Licensee shall have reasonable opportunities to advise Brandeis and shall cooperate with Brandeis in such filing, prosecution and maintenance. Brandeis will cooperate with Licensee to manage patent costs.

6. INFRINGEMENT

6.1 Notice. If Licensee becomes aware of any actual, potential, or threatened infringement, misappropriation, act of unfair competition, or other harmful or wrongful activities of third parties with respect to the Patent Rights, Licensee shall, with reasonable promptness, notify Brandeis and provide relevant information and documentation. Licensee will not notify a third party of the infringement of any Patent Rights without first obtaining consent of Brandeis.

6.2 Enforcement by Licensee. So long as Licensee remains the exclusive licensee of the Patent Rights in the License Fields in the Territory, Licensee, to the extent permitted by law, shall have the right, under its own control and at its own expense, to prosecute any third party infringement of the Patent Rights in the License Fields in the Territory, subject to Sections 6.2.1 and 6.2.2, below. If required by law, Brandeis shall permit any action under this Section to be brought in its name, including being joined as a party-plaintiff, provided that Licensee shall hold Brandeis harmless from, and indemnify Brandeis against, any costs, expense or liability that Brandeis incurs in connection with such action; provided that Licensee shall not be obligated to indemnify Brandeis against any liability under this Section 6.2 that Brandeis incurs as a result of its own gross negligence or willful misconduct as determined by a court of final adjudication after exhaustion of all available appeals.

Prior to commencing any action, Licensee shall consult with Brandeis and shall consider the views of Brandeis regarding the advisability of the proposed action and its effect on the public interest. Licensee shall not enter into any settlement, consent, judgment or other voluntary final disposition of any infringement action under this Section without the prior written consent of Brandeis.

6.2.1 Payment of Royalties. If Licensee brings an action under this Section 6.2, Licensee may deduct from its royalty payments due to Brandeis pursuant to Exhibit A.1, an amount not to exceed [***] percent ([***]%) of Licensee’s documented and actually paid or currently outstanding, costs and expenses of such action, including reasonable attorneys’ fees, up to a total of [***] percent ([***]%) of the total royalty due to Brandeis in any Accounting Period.

6.2.2 Treatment of Proceeds. Any recovery or damages for past infringement derived therefrom or any amounts paid as a result of a settlement agreement (the “Gross Proceeds”) shall be applied first in satisfaction of any unreimbursed expenses and reasonable legal fees of the parties,. [***].

6.3 Enforcement by Brandeis. In the event that Licensee is unsuccessful in persuading the alleged infringer to desist or fails to have initiated an infringement action within [***] ([***]) months after Licensee first becomes aware of the basis for such action, Brandeis shall have the right, at its sole discretion, to prosecute such infringement under its sole control and at its sole expense, and any recovery obtained shall belong to Brandeis.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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6.4 Actions for Declaratory Judgment. If a declaratory judgment action alleging invalidity or infringement of any of the Patent Rights is brought against Licensee, Brandeis, within [***] ([***]) days of being notified of such action, in its sole discretion, shall have the right (but not the obligation) to intervene and take over the sole defense of the action at its own expense. Licensee shall cooperate fully with Brandeis in connection with any such action. Any recovery of damages by Brandeis shall be applied first in satisfaction of any unreimbursed expenses of both Brandeis and Licensee. If Brandeis elects not to intervene, Licensee may assume the defense and may escrow royalties, otherwise due Brandeis pursuant to Section 6.2.1 and apportion damages in the same proportions and to the same extent as set forth in Section 6.2.2 hereof. [***].

6.5 Cooperation. In any infringement suit as either party may institute to enforce Patent Rights or in any defense of Patent Rights pursuant to this Agreement, the other party hereto shall, at the request and expense of the party initiating such suit, cooperate in all respects to the extent reasonably possible.

6.6 Non-Assert. Notwithstanding other provisions of this Article 6, Licensee (including its Affiliates and Sublicensees) and Brandeis agree that the Patent Rights shall not be asserted against not-for-profit research institutions for use on research funded by the institutions themselves, by not-for-profit foundations, by the Howard Hughes Medical Institute, by any state government, or by the Federal Government. Licensee may assert the Patent Rights [***], and may assert the Patent Rights [***].

6.7 Survival. The provisions of this Section 6 shall survive any termination of this Agreement but only in respect of proceedings commenced prior to the date of termination for alleged or actual acts of infringements occurring during the term of this Agreement.

7. INDEMNIFICATION; INSURANCE

7.1 By Licensee. Licensee shall indemnify, defend and hold harmless Brandeis, and its current or former trustees, officers, governing board members, faculty, professional staff, employees, students, agents and Affiliates, and their respective successors, heirs and assigns (collectively, “Indemnitees”), against any and all liability, damage, loss, claim or expense (including legal expenses and reasonable attorneys’ fees) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of or in connection with the transport, handling, research, development, design, manufacture, commercialization, marketing, sale, use, lease, consumption or advertisement of Licensed Products, including any actual or alleged injury, damage, death or other consequence occurring to any persons or property, and including against any claim that activities under this License Agreement infringe a third party’s intellectual property rights, and against any other claim, proceeding, demand, expense and liability of any kind whatsoever (including, without limitation, actions in the form of tort warranty, or strict liability) resulting, directly or indirectly, from the possession, use or consumption of any Licensed Products or arising from any obligation of Licensee hereunder; provided that Licensee shall not be obligated

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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to indemnify the Indemnitees against any liability under this Section 7.1 that the Indemnitees incur as a result of their own gross negligence or willful misconduct as determined by a court of final adjudication after exhaustion of all available appeals. Licensee shall, at its own expense, provide attorneys reasonably acceptable to Brandeis to defend against any actions brought or filed against any Indemnitee hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.

7.2 Insurance. Prior to first dosing of humans in a Phase I clinical trial with Licensed Product, Licensee shall, at its sole cost and expense, procure and maintain, or cause to be maintained (i) commercial general liability insurance, on an occurrence basis, in amounts not less than $[***] per occurrence and $[***] annual aggregate and, (ii) product liability insurance in amounts not less than $[***] per claim and $[***] annual aggregate. Such insurance policies shall (i) be through an insurance company with an A.M. Best minimum rating of [***]; (ii) name the Indemnitees as additional insureds; (iii) [***]; and (iv) [***]. The minimum amounts of insurance coverage required under this Section 7.2 shall not be construed to create a limit of Licensee’s liability with respect to its indemnification under Section 7.1.

7.2.1 Licensee shall provide Brandeis with an acceptable certificate as written evidence of such insurance prior to the use in humans of any Licensed Product. Licensee shall provide Brandeis with written notice at least [***] ([***]) days prior to the cancellation, nonrenewal or material reduction in such insurance; if Licensee does not obtain replacement insurance providing comparable coverage prior to the expiration of such [***] ([***]) day period, Brandeis shall have the right to terminate this Agreement effective at the end of such [***] ([***]) day period without notice or any additional waiting periods.

7.2.2 Licensee shall maintain such insurance beyond the expiration or termination of this Agreement during (i) the period that any such Licensed Product, process, or service is being commercially distributed or sold by any Seller and (ii) a reasonable period after the period referred to in (i) but in no event less than [***].

7.3 IN NO EVENT SHALL BRANDEIS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER BRANDEIS KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. BRANDEIS’ AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY LICENSEE TO BRANDEIS UNDER THIS AGREEMENT. The foregoing exclusions and limitations shall apply to all claims and actions of any kind, whether based on contract, tort (including but not limited to negligence), or any other grounds.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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8. DISCLAIMER

BRANDEIS MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADE SECRET, TANGIBLE RESEARCH PROPERTY, TECHNOLOGY, INFORMATION, KNOW-HOW OR DATA LICENSED OR OTHERWISE PROVIDED TO LICENSEE HEREUNDER AND HEREBY DISCLAIMS THE SAME. THE PATENT RIGHTS AND KNOW-HOW ARE PROVIDED AS IS. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY BRANDEIS THAT THE PRACTICE BY LICENSEE OR THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY.

Licensee understands and acknowledges that Brandeis, by this Agreement, makes no representation as to the operability or fitness for any use, safety, efficacy, approvability by regulatory authorities, time and cost of development, patentability, and/or breadth of the Patent Rights, by this Agreement. Brandeis also makes no representation as to whether there are any patents now held, or which will be held, by others or by Brandeis which may be dominant or subordinate to Patent Rights.

9. TERMINATION

9.1 Term. Unless sooner terminated as provided for in this Agreement, the license to Patent Rights granted hereunder will be effective upon the Effective Date and will continue on a country by country basis until the first to occur:

(a) one (1) year after the date Licensee, its Affiliates, or Sublicensees shall last sell any Licensed Product in such country; or

(b) until the last to expire of any Patent Right, the claims of which but for this Agreement would be infringed by the manufacture, use or sale of any Licensed Product in the applicable country.

9.2 Termination.

9.2.1 Breach. If Licensee breaches any of its financial obligations under this Agreement, Brandeis may give written notice of the default to Licensee. Unless such default is corrected within thirty (30) days after such notice, Brandeis may immediately terminate this Agreement and the license hereunder without any additional notice. Only one such thirty (30) day grace period shall be available in any twelve (12) month period with respect to a default of any particular financial provision hereunder. Thereafter notice of default of such provision shall constitute immediate termination. If Licensee materially breaches any of its obligations, other than the financial obligations specified above in this paragraph, Brandeis may give written notice of the default to Licensee. Unless such default is corrected within sixty (60) days after such notice, Brandeis may immediately terminate this Agreement and the license hereunder without any additional notice. Only one such sixty (60) day grace period shall be available in any twelve (12) month period with respect to a default of any particular non-financial provision hereunder. Thereafter notice of default of such provision shall constitute immediate termination.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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9.2.2 Bankruptcy. Licensee must provide notice to Brandeis of its intention to file a voluntary petition in bankruptcy or, where known to Licensee, of another party’s intention to file an involuntary petition in bankruptcy for Licensee, within at least thirty (30) days prior to filing such petition. Brandeis may terminate this Agreement upon receipt of such notice at its sole discretion. Licensee’s failure to provide such notice to the University will be deemed a material, pre-petition, incurable breach of this Agreement and the Agreement will terminate automatically on the date of filing such voluntary or involuntary petition in bankruptcy.

9.3 Effect of Termination.

9.3.1 Sublicenses. Upon any termination, all licenses granted to Licensee and Affiliates under this Agreement are terminated, however, any sublicense under such license granted prior to termination shall remain in full force and effect, provided that:

(a) Brandeis receives all payments due hereunder; and

(b) the Sublicensee is not then in breach of its sublicense agreement; and

(c) the Sublicensee assumes in writing Licensees’ or the applicable Affiliates’ obligations under, and the terms and conditions of this Agreement; and

(d) Brandeis shall have the right to receive the greater of (a) [***] or (b) the lowest royalty which is within the “Competitive” range as hereinafter defined, at the time Brandeis’ license to Licensee is terminated. A royalty rate shall be regarded as “Competitive” if it is within the range of royalty rates that [***]; and

(e) Brandeis shall not assume, and shall not be responsible to such Sublicensee for, any representations, warranties or obligations of Licensee to such Sublicensee, other than to permit such Sublicensee to exercise any rights to Patent Rights that are granted under such sublicense agreement consistent with the terms of this Agreement.

9.3.2 Obligations. Termination of this Agreement does not relieve Licensee or any Affiliate of any obligation or liability accrued by Licensee or any Affiliate prior to the effective date of such termination or affect any rights of Brandeis arising under this Agreement prior to termination. Also, upon any termination of this Agreement, whether by Brandeis or by Licensee, Licensee and its Affiliates shall cease all use of the Patent Rights and Know-How, and shall, upon request, return or destroy (at Brandeis’ option) all tangible embodiments thereof under its control or in its possession.

9.4 Survival. In addition to provisions that expressly provide for survival, Sections 1, 4.4, 6, 7, 8, 9.3, 9.4, and 10.5 survive termination of this Agreement.

10. MISCELLANEOUS

10.1 Relationship of the Parties. The parties to this Agreement are independent contractors. It is expressly agreed that in exercising its rights granted hereunder, each party is acting as independent contractor and not as agent or employee of the other party, and nothing contained in this Agreement shall be construed to create an agency, joint venture, or partnership between the parties. Neither party shall have any right, power or authority to enter into any agreement for or on behalf of, or incur any obligation or liability of, or to otherwise bind, the other party.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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10.2 Use of Names; Publicity. Except as required by law, neither party shall use the name of the other party or any of their respective officers, employees, students, consultants, Affiliates or agents (or any trade-name, trademark, trade device, service mark, symbol, or any abbreviation, contraction or simulation thereof owned by the other party or any of their respective officers, employees, students, consultants, Affiliates or agents) in any press release, promotional material or other publicity without the prior written consent of the other party.

10.3 Notice. Any notices or other communications required or permitted hereunder shall be sufficiently given if delivered personally, sent by reputable overnight delivery service (such as Federal Express or Airborne Express) or sent by first class certified United States mail, postage prepaid, addressed as follows or to such other address of which the parties may have given notice:

To Brandeis:

Director

Office of Technology Licensing

Brandeis University

415 South Street, MS 115

Waltham, Massachusetts 02454-9110

To Licensee:

c/o Fidelity Biosciences Corp.,

One Main Street, 13th Floor,

Cambridge, MA 02142,

Attention: [***]

Unless otherwise specified herein, such notices or other communications shall be deemed received (a) on the date delivered, if delivered personally, (b) one business day after being sent, if sent by reputable overnight delivery service or (c) three business days after being sent, if sent by certified mail.

10.4 Assignment. This Agreement may not be assigned or otherwise transferred by Licensee without the prior written consent of Brandeis, such consent not to be unreasonably withheld, delayed or conditioned. Notwithstanding the foregoing, this Agreement may be assigned by Licensee without the consent of Brandeis (a) to an Affiliate , and (b) in connection with the transfer or sale, directly or indirectly, of all or substantially all of the assets and business of Licensee to a third party, whether by merger, sale of stock, sale of all or substantially all assets, consolidation, recapitalization, or other business combination, provided that, with respect to (a) and (b) above, (i) Licensee is in good standing, (ii) any such permitted assignee shall assume all obligations of its assignor under this Agreement in writing, (iii) Licensee or assignee shall deliver a fully executed copy of such assumption of obligations to Brandeis within [***] ([***]) days of completing the assignment, and (iv) [***]. Any purported assignment in violation of this Section shall be null and void.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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10.5 Governing Law. This Agreement shall be governed by and construed in accordance under the laws of The Commonwealth of Massachusetts, without giving effect to its principles of conflict or choice of laws. Each of the parties hereto agree that any action at law or in equity arising out of or relating to this Agreement shall be filed exclusively in courts of competent jurisdiction located in Boston, Massachusetts. Each party hereby consents to the personal jurisdiction of the courts in The Commonwealth of Massachusetts.

10.6 Entire Agreement; Amendments. This Agreement and its Exhibits represent the entire understanding and agreement between the parties hereto with respect to the subject matter hereof and supersede all prior oral and written and all contemporaneous oral negotiations, commitments and understandings between such parties. This Agreement may not be modified or amended except by a written agreement duly executed by both parties hereto.

10.7 Waivers. No delay on the part of any party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any waiver on the part of any party of any such right, power or privilege, nor any single or partial exercise of any such right, power or privilege, preclude any further exercise thereof or the exercise of any other such right, power or privilege. The rights and remedies of any party based upon, arising out of or otherwise in respect of any inaccuracy in or breach of any representation, warranty, covenant or agreement contained in this Agreement shall in no way be limited by the fact that the act, omission, occurrence or other state of facts upon which any claim of any such inaccuracy or breach is based may also be the subject matter of any other representation, warranty, covenant or agreement contained in this Agreement (or in any other agreement between the parties) as to which there is not inaccuracy or breach.

10.8 Section Headings. The Section headings are for the convenience of the parties and in no way alter, modify, amend, limit, or restrict the contractual obligations of the parties.

10.9 Severability. If any part of this Agreement is ruled to be invalid, illegal, or unenforceable by a court or other body of competent jurisdiction, the remainder of this Agreement shall continue in full force and effect and shall be deemed modified to the minimum extent necessary to make it enforceable. If any such ruling in question is subsequently overruled or obviated by legislative or other action, the severed provisions of this Agreement shall return to full force and effectiveness.

10.10 Counterparts. This Agreement may be executed in two or more counterparts, which may be facsimile counterparts, each of which shall be deemed to be an original, but all of which shall be deemed collectively one and the same instrument.

10.11 Export Control. Licensee acknowledges and agrees that Brandeis is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (including the Arms Export Control Act, as amended and the Export Administration Act of 1979), and that its obligations hereunder are contingent on compliance with applicable United States export laws and regulations. The transfer

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Licensee that Licensee shall not export data or commodities to certain foreign countries, or to any individuals or entities on the U.S. Treasury Department’s List of Specifically Designated Nationals or the U.S. Commerce Department Table of Designated Orders without prior approval of such agency. Brandeis neither represents that a license shall not be required nor that, if required, it shall be issued.

10.12 Marking. Licensee agrees to mark Licensed Products sold in the United States with all applicable United States patent numbers as appropriate. All Licensed Products shipped to or sold in other countries shall be marked in such manner as to conform with the patent laws and practice of the country of manufacture or sale.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized officers as of the Effective Date.

 

BRI-ALZAN INC.   BRANDEIS UNIVERSITY
By:  

/s/ Stacie Weninger

 

By:

 

/s/ Irving R Epstein

Name:   Stacie Weninger   Name:  

Irving R Epstein, Ph.D.

Title:   President   Title:  

Interim Executive Director

      Office of Technology Licensing

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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EXHIBIT A

A.1 Royalty Rate. Beginning with the First Commercial Sale in any country, and on all sales thereafter of Licensed Products anywhere in the world by any Seller, so long as the Patent Rights are in effect, Licensee shall pay Brandeis royalties for each Licensed Product sold by each Seller as follows:

(i) [***] percent ([***]%) of the Net Sales Price of Licensed Products.

(ii) One Royalty. Only one royalty under Section A.1 shall be due and payable to Brandeis by any Seller for any Licensed Product regardless of the number of Patent Rights covering such Licensed Product.

A.2 License Maintenance Fees. Licensee shall pay to Brandeis the following license maintenance fees on the dates set forth below. Such license maintenance fees are waived while the Research Agreement is in effect.

 

Payment Date

   Amount due from
Licensee prior to Change of
Control
  Amount due from
Licensee after Change of
Control

(i) January 1, 2013 and January 1, 2014

   $[***]   $[***]

(ii) January 1, 2015, and each January 1 thereafter until [***]

   $[***]   $[***]

(iii) January 1 of each year after [***]

   $[***]   $[***]

License maintenance fees are nonrefundable; however, the license maintenance fee may be credited to running royalties and sublicense payments subsequently due on Net Sales earned during the same calendar year, if any. License maintenance fees paid in excess of running royalties and sublicense payments due in such calendar year shall not be creditable to amounts due for future years.

A.3 Milestone Payments. Licensee shall pay to Brandeis the following milestone payments due and payable within [***] ([***]) days of the first occurrence of the following events:

 

Milestone

   Milestone Amount

(i) [***]

   $[***]

(ii) [***]

   $[***]

(iii) [***]

   $[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


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A.4 Equity.

(i) Initial Grant. Licensee shall issue a total of one hundred (100) shares of Common Stock of Licensee, $0.01 par value per share, (the “Shares”) in the name of Brandeis. Such issuance shall be recorded on the Stock Transfer Ledger of Licensee on the Effective Date and the Shares shall be delivered to Brandeis within thirty (30) days of the Effective Date.

Company represents to Brandeis that, as of the Effective Date, the aggregate number of Shares equals Five Percent (5%) of the Licensee’s issued and outstanding Common Stock calculated on a “Fully Diluted Basis.” For purposes of this Section A.4, “Fully Diluted Basis” shall mean that the total number of issued and outstanding shares of the Licensee’s Common Stock shall be calculated to include conversion of all issued and outstanding securities then convertible into common stock, the exercise of all then outstanding options and warrants to purchase shares of common stock whether or not then exercisable, and shall assume the issuance or grant of all securities reserved for issuance pursuant to any Licensee stock or stock option plan in effect on the date of the calculation.

(ii) Anti-Dilution Protection. [***].

(iii) Assignment of License Agreement. If Licensee assigns the License Agreement as permitted in Section 10.4, and such assignment does not result in all of Licensee’s equity holders exchanging their equity in Licensee for new equity in the assignee, then, at Brandeis’ option in its sole discretion, Brandeis shall [***]. This provision shall apply to each and every assignee permitted without the prior consent of Brandeis under Section 10.4.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


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A.5 Sublicense Lump Sum Payments. In addition to the royalties provided for above, Licensee shall pay Brandeis [***] percent ([***]%) (hereinafter “Lump Sum Percentage”) of all lump sum payments received from Sublicensees (hereinafter “Lump Sum Payments”), excluding any payments made specifically for reimbursement of actual research support expenses, and excluding royalties on Net Sales, which are accounted for in Section A. 1, above. Such payments shall be made to Brandeis within [***] ([***]) days after Licensee receives any Lump Sum Payment from a Sublicensee under any sublicense.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


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EXHIBIT B

Patent Rights

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

EXECUTION COPY

FIRST AMENDMENT TO LICENSE AGREEMENT

THIS FIRST AMENDMENT TO THE LICENSE AGREEMENT is made effective as of this 31 day of December, 2015 (this “Amendment”) by and between Brandeis University, a not- for-profit corporation duly organized and existing under the laws of The Commonwealth of Massachusetts and having its principal place of business at 415 South Street, Waltham, Massachusetts 02454-9110 (“Brandeis”), and BRI-Alzan Inc., a corporation duly organized and existing under the laws of the State of Delaware having its offices at c/o F-Prime Inc., One Main Street, 13th Floor, Cambridge, Massachusetts 02142 (hereinafter referred to as “Licensee”). MeiraGTx Limited, a private limited company duly formed under the laws of England and Wales, joins in this Amendment solely for the limited purposes set forth in Paragraph 2.a.

WHEREAS, Brandeis and Licensee are parties to that certain License Agreement effective as of May 1, 2013 (the “License Agreement”);

WHEREAS, Licensee is entering into that certain Agreement and Plan of Merger dated as of the date hereof (the “Merger Agreement”) by and among Licensee, MeiraGTx Acquisition Corporation, a Delaware corporation (“Merger Sub”), the stockholders of Licensee comprised of F-Prime Inc. (f/k/a Fidelity Biosciences Corp.) (“Fidelity”), Gregory Petsko, Dagmar Ringe and Brandeis (collectively, the “Sellers”), Fidelity, solely in its capacity as representative of the Sellers, and MeiraGTx Limited, a private limited company duly formed under the laws of England and Wales and the sole stockholder of Merger Sub (“Parent”), pursuant to which Licensee will merge with and into Merger Sub with Licensee surviving the merger and thereby becoming a wholly-owned subsidiary of Parent (the “Merger”);

WHEREAS, as part of the consideration for the Merger, Parent will have certain conditional obligations to make the Contingent Payments (as defined in the Merger Agreement), subject to the terms and conditions of (and solely to the extent required by) the Merger Agreement;

WHEREAS, Parent, in connection with the Merger, has requested certain changes to the License Agreement, to which its subsidiary will be a party after the Merger; and

WHEREAS, in connection with the Merger and the acknowledgements herein below set forth in Paragraph 2, Brandeis and Licensee are willing to amend the License Agreement in certain respects as herein set forth.

NOW, THEREFOR, in consideration of the Merger Consideration (as defined in, and subject in all respects to the terms and conditions set forth in, the Merger Agreement) and the mutual promises and agreements herein set forth, Brandeis and Licensee do hereby agree as follows:

1. Definitions. Capitalized terms used, but not otherwise defined in this Amendment, shall have the meanings assigned to such terms under the License Agreement.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


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2. Acknowledgments.

(a) Parent. Parent hereby acknowledges and agrees that if (i) the License Agreement is assigned after the consummation of the Merger such that another Person, who is not a direct or indirect Affiliate of Parent has assumed Licensee’s obligations to Brandeis under the License Agreement (as amended by this Amendment) (each, a “Permitted Transferee”), and (ii) Parent does not also assign its obligations to make the Contingent Payments under the Merger Agreement to such Permitted Transferee or a direct or indirect Affiliate thereof, then (x) Parent’s then-remaining obligations under the Merger Agreement to make the Contingent Payments (subject to, and in accordance with, the terms and conditions of the Merger Agreement) shall not be affected by such assignment of the License Agreement. For greater clarity, nothing in this Section 2(a) shall alter the requirements for a valid assignment under Section 7.7 of the Merger Agreement.

(b) Brandeis. Solely with respect to the transfer of the License Agreement in connection with the Merger, Brandeis agrees to waive application of the higher license maintenance fees for a Change of Control set forth in Section A.2 of Exhibit A of the License Agreement and that the license maintenance fees set forth in column captioned “Amount due from Licensee prior to Change of Control” shall remain in effect immediately following the consummation of the Merger. Neither Parent nor any Person that is an Affiliate of Parent (which shall include the Licensee) shall be bound to issue or otherwise deliver to Brandeis by virtue of the Merger at any time from and after the completion of the Merger any equity other than the Parent Shares allocated to Brandeis on Schedule 2.1.5 to the Merger Agreement. Notwithstanding anything to the contrary in the License Agreement, Brandeis hereby consents to the Merger. Brandeis further acknowledges and agrees that from and after the completion of the Merger, the License Agreement, as amended by this Amendment, shall remain and continue in full force and effect.

(c) Licensee. Licensee hereby acknowledges and agrees that the consummation of the Merger does not terminate or otherwise alter or affect its obligations to Brandeis under the terms and conditions of the License Agreement, as amended by this Amendment, which shall remain and continue in full force and effect from and after the completion of the Merger.

3. Amendments to License Agreement. Brandeis and Licensee hereby amend the License Agreement as follows:

(a) The definition of the term “Change of Control” contained in Section 1.4 of the License Agreement is hereby amended to add the following after at the end of the paragraph:

A “Change of Control” shall not include a public offering of capital stock of Licensee or of the share capital of Parent or of a holding company of Parent, so long as Parent or such holding company of Parent is an Affiliate of Licensee.

(b) The definition of the term “Gross Sales” contained in Section 1.7 of the License Agreement is hereby deleted and amended and restated in its entirety as follows:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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“Gross Sales” or “Gross Sales Price” means for any arm’s length sale, transfer, dispositions or other dealing to a customer by a Seller, the Gross Sales Price shall be the gross amount invoiced by the Seller for the sale, transfer or other disposition of or dealing with a Licensed Product.

Transfer of a Licensed Product within the Licensee or between Licensee, Sublicensee or an Affiliate shall not be considered a sale, commercial use or disposition for the purpose of the foregoing paragraphs; in the case of such transfer the Gross Sales Price shall be based on sale of the Licensed Product by the transferee. If a Seller commercially uses or disposes of any Licensed Product by itself other than in an arm’s length sale to a bona fide customer, the Gross Sales Price hereunder shall be the price which would be then payable in an arm’s length transaction. [***] The “Gross Sales” or “Gross Sales Price” shall not include transfers or dispositions for charitable, compassionate, promotional, pre- clinical, clinical, regulatory, or governmental purposes.

For any sale of a Licensed Product to which the United States government is entitled to a royalty-free right pursuant to 35 USC 202(c)(paragraph 4), [***].

(c) The definition of the term “Net Sales” contained in Section 1.12 of the License Agreement is hereby deleted and amended and restated in its entirety as follows:

“ “Net Sales” or “Net Sales Price” means the Gross Sales Price received by a Seller less (to the extent appropriately documented) the following amounts actually paid out by a Seller or credited against the amounts received by it from the sale or distribution of Licensed Product:

(a) credits, allowances and price adjustments for damaged, defective or rejected Licensed Products or for the rejection or return of Licensed Products previously sold;

(b) rebates, chargeback payments and trade, cash and quantity discounts to purchasers allowed and taken;

(c) amounts for transportation, insurance, handling or shipping charges or directly related to the sale or distribution of Licensed Product and listed on the invoices or purchase order for such Licensed Product;

(d) taxes, tariffs, duties and other governmental charges levied on or measured by the sale of Licensed Products, whether absorbed by the Seller or paid by the purchaser so long as the Seller’s price is reduced thereby, but not franchise or income taxes of any kind whatsoever;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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For Net Sales of a Licensed Product sold or supplied as a Combination Product, the Net Sales of such a Combination Product will be determined, subject to the provisions set forth below in this Section 1.12, by multiplying the actual Net Sales of such Combination Product in a particular country in the Territory by the fraction of A/(A+B), where A is the average Gross Sales billed or invoiced per unit of such Licensed Product in such country in the Territory during the period in respect of which Net Sales are being calculated of the Licensed Product sold separately and B is the total average Gross Sales billed or invoiced per unit in such country in the Territory of the other active ingredient (including a biologic product) or device included in the Combination Product during the period in respect of which Net Sales are being calculated, when sold separately. If neither the Licensed Product nor the other active ingredient (including a biologic product) or device included in the Combination Product are sold separately as a monotherapy during the period in respect of which Net Sales are being calculated, then the fair market value of the other active ingredient (including a biologic product) or device included in the Combination Product that is to be deducted from the Net Sales of the Combination Product in determining the Net Sales of the Licensed Product contained in the Combination Product shall be equal to the fair market value of such other active ingredient (including a biologic product) or device included in the Combination Product as determined in accordance with the provisions of the Merger Agreement for such Licensed Product. As used herein, a “Combination Product” means a product which comprises (a) a Product and (b) at least one other active ingredient (including a biologic product) or medical device.”

Subject to the above, Net Sales shall be calculated in accordance with United Kingdom generally accepted accounting principles (or U.K. GAAP), consistently applied with the past practice of the Licensee and its Affiliates.”

(d) Exhibit A to the License Agreement is hereby deleted in its entirety and amended, restated and replaced in its entirety with Exhibit A attached to this Amendment. On and after the Effective Date of this Amendment, each reference to Exhibit A in the License Agreement shall mean and be a reference to Exhibit A attached to this Amendment.

(e) Exhibit B to the License Agreement is hereby deleted in its entirety and amended, restated and replaced in its entirety with Exhibit B attached to this Amendment. On and after the Effective Date of this Amendment, each reference to Exhibit B in the License Agreement shall mean and be a reference to Exhibit B attached to this Amendment.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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(f) Section 3.1(a) of the License Agreement is hereby amended to delete the phrase “During the last [***] ([***]) months of the Research Agreement Term,” and to substitute the following phrase: “On or prior to June 30, 2016,”

(g) Section 3.3 of the License Agreement is hereby amended to add the following after at the end of the paragraph:

As of the Effective Date of this Amendment, it is understood that Licensee does not have any obligations, financial or otherwise, under the Research Agreement.

(h) The address for notice for Licensee set forth in Section 10.3 of the License Agreement is amended as follows:

“To Licensee:

c/o MeiraGTx Limited

450 East 29th Street, 5th Floor

New York, New York 10016

Attn: [***]”

(i) The second sentence of Section 10.4 of the License Agreement is hereby deleted and amended and restated in its entirety as follows:

“Notwithstanding the foregoing, this Agreement may be assigned by Licensee without the consent of Brandeis (a) to an Affiliate, and (b) in connection with the transfer or sale, directly or indirectly, of all or substantially all of the assets and business of Licensee to a third party, whether by merger, sale of stock, sale of all or substantially all assets, consolidation, recapitalization, or other business combination, provided that, with respect to (a) and (b) above, (i) Licensee is in good standing under the laws of its jurisdiction of incorporation or formation, (ii) any such permitted assignee (1) has total net assets (total assets minus total liabilities) reflected on its balance sheet as of the end of the then most recently completed fiscal year that are equal to or greater than Licensee’s total net assets as reflected on a balance sheet as of the end of Licensee’s then most recently completed fiscal year, (2) (A) is not the subject of any litigation or proceeding (including, but not limited to arbitration), in law or in equity, and (B) there are no proceedings or known governmental investigations before any administrative or governmental authority (including any commission), pending or threatened against such permitted assignee, in each case with respect to clauses (A) and (B), that would reasonably be expected to impair its ability to fulfill its obligations under the License Agreement, and (3) shall assume all obligations of its assignor under this Agreement in writing, and (iii) Licensee or assignees shall deliver a fully executed copy of such assumption of obligations to Brandeis within [***] ([***]) days of completing the assignment. For purposes of this Section 10.4, “known” shall mean “known by such permitted assignee.””

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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4. Representations . Brandeis hereby represents and warrants to the Licensee, and Licensee hereby represents and warrants to Brandeis, that this Amendment has been duly authorized and executed and delivered by such party and is a legal, valid, binding and enforceable obligation of such party, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally and by general principles of equity.

5. No Implied Amendments . Except as herein provided, the License Agreement shall remain in full force and effect and are ratified in all respects. On and after the Effective Date of this Amendment, each reference in the License Agreement to “this Agreement,” “hereunder,” “hereof,” “herein,” or words of like import, and each reference to the License Agreement in any other agreements, documents or instruments executed and delivered from and after the Effective Date of this Amendment, shall mean and be a reference to the License Agreement, as amended by this Amendment.

6. Governing Law . This Amendment shall be construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to the choice of laws rules thereof, and the obligations, rights and remedies of the parties hereunder shall be determined in accordance with such laws. Any legal suit, action or proceeding against any of the parties hereto arising out of or relating to this Amendment shall only be instituted in any federal or state court located in Boston, Massachusetts, and each party hereby irrevocably submits to the exclusive jurisdiction of any such court in any such suit, action or proceeding. The parties hereby agree to venue in such courts and hereby waive, to the fullest extent permitted by law, any claim that any such action or proceeding was brought in an inconvenient forum. Each of the parties hereby irrevocably waives all right to trial by jury in any action, proceeding or counterclaim arising out of or relating to this Amendment.

7. Entire Agreement . This Amendment (including the Exhibit hereto) together with the License Agreement and the Merger Agreement constitute the entire agreement among the parties with respect to the subject matter hereof and supersede all prior agreements, understandings and undertakings, both written and oral, among the parties, or any of them, with respect to the subject matter hereof.

8. Counterparts .. This Amendment may be executed in several counterparts, each of which will be deemed an original but all of which will constitute one and the same.

9. Effective Date . For the avoidance of doubt, this Amendment shall be effective upon the completion of the Merger pursuant to the Merger Agreement as evidenced by the filing by Licensee of a certificate of merger with the Secretary of State of the State of Delaware.

[ Remainder of page intentionally left blank. ]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly authorized officers as of the Effective Date.

 

WITNESS/ASSEST:   BRANDEIS UNIVERSITY
By:  

/s/ Diane P. Walsh

  By:  

/s/ Rebecca Menapace

Name:   Diane P. Walsh   Name:   Rebecca Menapace
Title:  

Dept. Coordinator, OTL

  Title:  

Associate Provost for Innovation

  Brandeis University     Executive Director, OTL
  BRI-ALZAN INC.
By:  

/s/ Allan S. Galper

  By:  

/s/ Stacie Weninger Barnes

Name:   Allan S. Galper   Name:   Stacie Weninger Barnes
Title:   Secretary   Title:   President
 

For the limited purposes set forth in Paragrah 2.a. of this Amendment:

 

MEIRAGTx LIMITED

By:  

/s/ Richard Giroux

  By:  

/s/ Zandy Forbes

Name:   Richard Giroux   Name:   Zandy Forbes
Title:   COO   Title:   CEO

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


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EXHIBIT A

A.l Royalty Rate. Beginning with the First Commercial Sale in any country, and on all sales thereafter of Licensed Products anywhere in the world by any Seller, so long as the Patent Rights are in effect, Licensee shall pay Brandeis royalties for each Licensed Product sold by each Seller as follows:

(i) [***] percent ([***]%) of the Net Sales Price of Licensed Products.

(ii) One Royalty. Only one royalty under Section A.l shall be due and payable to Brandeis by any Seller for any Licensed Product regardless of the number of Patent Rights covering such Licensed Product.

A.2 License Maintenance Fees. Licensee shall pay to Brandeis the following license maintenance fees on the dates set forth below.

 

Payment Date

   Amount due from Licensee
prior to Change of Control
  Amount due from Licensee
after Change of Control

(i) January 1, 2016, and each January 1 thereafter until [***]

   $[***]   $[***]

(ii) January 1 of each year after [***]

   $[***]   $[***]

License maintenance fees are nonrefundable; however, the license maintenance fee may be credited to running royalties and sublicense payments subsequently due on Net Sales earned during the same calendar year, if any. License maintenance fees paid in excess of running royalties and sublicense payments due in such calendar year shall not be creditable to amounts due for future years.

A.3 Milestone Payments. Licensee shall pay to Brandeis the following milestone payments due and payable within [***] ([***]) days of the first occurrence of the following events:

 

Milestone

   Milestone Amount

(i) [***]

   $[***]

(ii) [***]

   $[***]

(iii) [***]

   $[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

A.4 Sublicense Lump Sum Payments. In addition to the royalties provided for above, Licensee shall pay Brandeis [***] percent ([***]%) (hereinafter “Lump Sum Percentage”) of all lump sum payments received from Sublicensees (hereinafter “Lump Sum Payments”), excluding any payments made specifically for reimbursement of actual research support expenses, and excluding royalties on Net Sales, which are accounted for in Section A.l, above. Such payments shall be made to Brandeis within [***] ([***]) days after Licensee receives any Lump Sum Payment from a Sublicensee under any sublicense.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


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EXHIBIT B

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

EX-10.11

Exhibit 10.11

Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENCE AGREEMENT

between

UCL Business Plc

and

Athena Vision Ltd

Dated 4 February 2015

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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INDEX

 

1.    Definitions      3  
2.    Grant of Rights      7  
3.    Know-how and Confidential Information      11  
4.    Conflict of Interest      13  
5.    Consideration      13  
6.    Commercialisation      18  
7.    Access to Medicines and Ethical Licensing      21  
8.    Compliance with Laws      22  
9.    Intellectual Property      23  
10.    Warranties and Liability      25  
11.    Duration and Termination      29  
12.    General      35  

Schedule 1 Template Licence Addendum

     40  

Schedule 2 Appointment of Expert

     43  

Schedule 3 Definition of Tobacco Industry Funding (Revised 2009)

     44  

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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THIS AGREEMENT is made

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) ATHENA VISION LTD, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”) has developed certain ocular gene therapies and owns certain Intellectual Property relating to those gene therapies that the Licensee wishes to acquire rights to for the development and commercialisation of Licensed Products.

 

B. UCL has assigned, or will assign prior to the execution of the relevant Licence Addendum, to UCLB all of its right, title and interest in and to such Intellectual Property.

 

C. The parties have agreed to enter into this multiple licence agreement to govern the terms upon which, following the execution of a Licence Addendum, such Intellectual Property may be licensed to the Licensee.

 

D. It is the policy of UCLB that its activities in licensing intellectual property take into consideration ethical and socially responsible licensing principles, including ensuring that Licensed Products are made available to fulfil unmet needs in Developing Countries, and the Licensee acknowledges and agrees to carry out its activities under this Agreement in a manner which complies with ethical and socially responsible licensing principles and which is designed to fulfil such needs, all in accordance with the provisions of this Agreement.

NOW IT IS AGREED as follows:

 

1. DEFINITIONS

 

1.1 In this Agreement:

Agreement means this agreement (including the Schedules) and unless otherwise specified or the context otherwise requires, all Licence Addendums in respect of Licensed Technologies entered into between the parties hereunder;

Affiliate in relation to a Party, means any entity or person that Controls, is Controlled by, or is under common Control with that Party;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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At-Cost Markets means those markets in Developing Countries [***];

Claims means all demands, claims and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, costs and expenses of any nature whatsoever and all costs and expenses (including legal costs) incurred in connection therewith;

Commencement Date means 4 February 2015;

Commercial Third Party means a commercial entity that is not a Party of this Agreement;

Competing Product means any product, whether ready for marketing or in development that competes, or is likely to compete once developed, with any Licensed Product;

Confidential Information means the Know-how and all other technical or commercial information that:

 

  a) in respect of information provided in documentary form or by way of a model or in other tangible form, at the time of provision is marked or otherwise designated to show expressly that it is imparted in confidence or which a reasonable person would expect to be confidential; and

 

  b) in respect of information that is imparted orally, any information that the Disclosing Party or its representatives informed the Receiving Party at the time of disclosure or which a reasonable person would expect to be confidential;

Control means direct or indirect beneficial ownership of 50% (or, outside a Party’s home territory, such lesser percentage as is the maximum permitted level of foreign investment) or more of the share capital, stock or other participating interest carrying the right to vote or to distribution of profits of that Party, as the case may be;

Cost-Based Price means, in respect of each Licensed Product, [***];

CPI means the United Kingdom Consumer Prices Index as published by the UK Office for National Statistics (or any successor body) or, if that index ceases to exist or the basis of the index is fundamentally changed, the nearest equivalent UK official index of increases in consumer prices as agreed by the Parties or in the absence of agreement determined by an expert appointed in accordance with Clause 5.10;

Developing Country or Developing Countries refers to those countries that are:

 

  a) [***]; and

 

  b) to the extent not included in a);

 

  i) defined as of the Commencement Date [***]; and

 

  ii) all other countries that may be mutually agreed to by the University and Licensee from time to time;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Developing Country Manufacturer means a manufacturer of pharmaceutical products that is able to efficiently manufacture (either within or outside the Developing Country in which the At-Cost market exists), distribute and supply the Licensed Product in an At-Cost market at a Cost-Based Price;

Diligent Efforts means exerting such efforts and employing such resources as would normally be exerted or employed by [***], when utilizing sound and reasonable scientific, medical and business practice and judgment in order to develop the product in a timely manner and generate an economic return to the Parties from its commercialisation;

Disclosing Party has the meaning given in Clause 3.3;

Field means ocular gene therapy;

Founders means [***];

Indemnitees has the meaning given in Clause 10.6;

Intellectual Property means any and all patents, utility models, registered designs, unregistered design rights, copyright, database rights, rights in respect of confidential information, rights under data exclusivity laws, rights under orphan drug laws, rights under unfair competition laws, property rights in biological or chemical materials, extension of the terms of any such rights (including supplementary protection certificates), applications for and the right to apply any of the foregoing registered property and rights, and similar or analogous rights in any part of the Territory;

Know-how means in respect of each Licensed Technology:

 

  a) the inventions claimed in the relevant Patents;

 

  b) the technical information relating to the inventions claimed in the relevant Patents; and

 

  c) the know how and the Know-how Data (as defined in the relevant Licence Addendum) described in Appendix 1 to the relevant Licence Addendum;

Licence Addendum means an addendum in the form set out in Schedule 1, duly signed and executed by the authorised representatives of each of the Parties and annexed to this Agreement;

Licensed Products means in respect of each Licensed Technology, any and all products that are developed, manufactured, used, or sold by or on behalf of the Licensee or its Affiliates or Sub-licensees and which (a) are within (or are manufactured using a process described in) a Valid Claim of the relevant Patents and/or (b) incorporate, or their development or manufacture makes use of, any of the relevant Know-how;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Licensed Technology means Intellectual Property, Patents and Know how relating to each technology licensed by UCLB to the Licensee under Licence Addendums [***] to this Agreement;

Materials, with respect to each Licensed Technology, means any materials, documents and information that UCLB may provide to the Licensee under or in connection with this Agreement;

Net Receipts means in respect of the Licensed Products, [***];

Net Sales Value means in respect of the [***];

Parties means UCLB and the Licensee, and “Party” shall mean either of them;

Patents means in respect of the Licensed Technology, any and all of the patents and patent applications described in Appendix 1 to the relevant Licence Addendum including any continuations, continuations in part, extensions, reissues, divisions, and any patents, supplementary protection certificates and similar rights that are based on or derive priority from the foregoing;

Reasonable Developing Country Licence Terms means terms that meet the requirements of both UCL’s ethical and socially responsible licensing policy, which is at: (http://www.ucl.ac.uk/enterprise/about/policies/files/Global_access-final.pdf) and the following principles:

 

  a) the Licensee shall [***];

 

  b) the Developing Country licence terms [***] that shall not [***];

 

  c) if the Developing Country Manufacturer is granted any exclusive rights, the continued grant of those rights shall be conditional upon the Developing Country Manufacturer supplying At-Cost Markets at a Cost-Based Price and meeting market demand in that market; and

 

  d) the Licensee may impose reasonable conditions, including as to use of trade marks, trade dress, format and pack size, to differentiate the Licensed Product when sold in the At-Cost market from Licensed Products sold in other markets and to prohibit their export into other markets and territories, provided that such conditions or their implementation do not act as an unreasonable barrier to the prompt and efficient supply of Licensed Product in the At-Cost market;

Receiving Party means has the meaning given in Clause 3.3;

Regulatory Exclusivity means, with respect to a Licensed Product, any exclusive rights or protection which are recognised, afforded or granted by any Regulatory Authority in any country or region with respect to the Licensed Product other than through patent rights;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Shareholders’ Agreement means the shareholders’ agreement dated on or around the date of this Agreement between UCLB, the Licensee, the Founders and the Manager (as identified therein);

Specified Technology means any and all Intellectual Property owned by UCLB or its Affiliates relating to the following technologies:

[***]

where subject to Clause 2.4 such Intellectual Property is free from any ownership or other obligations of third parties when it arises or where any such ownership or other obligations to third parties which might exist when it arises have been discharged or waived;

Sub-licensee means in respect of each Licensed Technology, any third party (other than an Affiliate) to whom the Licensee grants a sub-licence of its rights under this Agreement in accordance with Clause 2.3;

Territory means Worldwide; and

Valid Claim means a claim of a patent or patent application that has not been abandoned or allowed to lapse or expired or been held invalid or unenforceable by a court of competent jurisdiction in a final and non-appealable judgment.

 

2. GRANT OF RIGHTS

 

2.1 Licence of Licensed Technology

UCLB hereby grants to the Licensee and its Affiliates, and the Licensee hereby accepts on its own behalf and on behalf of its Affiliates, in respect of the Licensed Technology from the effective date specified in the respective Licence Addendums and subject to the provisions of this Agreement, an exclusive licence to use and exploit the Licensed Technology, with the right to sub-license, (subject to Clause 2.3), to develop, manufacture, have manufactured, use, sell and have sold Licensed Products solely in the relevant Field and in the relevant Territory. The licence shall be exclusive even as to UCL subject to Clause 2.4.

 

2.2 UCLB shall at the Licensee’s request and cost execute such formal licences as may be necessary to enable the Licensee to register the licences granted to it under this Agreement with the Patent Offices in the relevant Territory. Such formal licence will reflect the terms of this Agreement where possible and for the avoidance of doubt if there is a conflict in the terms of such formal licence and this Agreement, the terms of this Agreement shall prevail. [***].

 

2.3 Sub-Licensing of Licensed Technology

The Licensee shall have the right to grant sub-licences under the licence in Clause 2.1 to its Affiliates or other third parties through one or more levels of Sub-licensees except that the Licensee may not grant such a sub-licence to any person or the Affiliates of any person

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

involved in: the tobacco industry (as defined by the Cancer Research UK Code of Practice on Tobacco Industry Funding to Universities detailed in Schedule 3); Arms dealing; gambling operations; the promotion of violence; child labour or any other illegal activity. A grant of any sub-licence shall be conditional on the following:

 

(a) The Licensee shall enter into a written agreement with each Sub-licensee and shall ensure that the provisions of each sub-licence are consistent with the provisions of this Agreement, and the Licensee shall ensure that:

 

  (i) the sub-licence sets out all the proposed terms agreed between the Licensee and the Sub-licensee, including, in particular, all terms as to remuneration;

 

  (ii) the Sub-licensee will maintain complete and accurate records in sufficient detail to permit UCLB to confirm the accuracy of the calculation of royalty payments under this Agreement; and

 

  (iii) the sub-licence imposes obligations of confidentiality on the Sub-licensee which are no less onerous than those set out in Clause 3.3.

 

(b) The Licensee shall procure that each Sub-licensee complies fully at all times with the provisions of its sub-licence.

 

(c) The Licensee shall be liable for all acts and omissions of its Sub-licensees that, if committed by the Licensee, would constitute a breach of any of the provisions of this Agreement.

 

(d) The Licensee shall provide UCLB with a copy of any sub-licence [***] ([***]) days after execution of such sub-licence, provided that the Licensee may redact confidential or proprietary terms from such copy, including financial terms.

 

(e) Each sub-licence shall terminate automatically upon termination of the relevant Licence Addendum for any reason (other than in the case of expiry of the relevant Licence Addendum under Clause 11.2) except where:

 

  (i) the Sub-licensee was not implicated in or at fault in any circumstances which led to the termination; and

 

  (ii) the benefit (but not the burden) of the sub-licence agreement is validly assigned to UCLB in writing within [***] ([***]) days following the date of termination; and

 

  (iii) the Sub-licensee agrees that, following assignment, the Sub-licensee will observe in full the terms of the sub-licence agreement including paying all sums due to the Licensee under the sub-licence agreement directly to UCLB in a timely manner,

in which case the Sub-licensee’s rights to use the relevant Licensed Technology shall continue in full force and effect in accordance with the terms of the relevant sub-licence agreement.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

2.4 Reservation of Rights

 

  2.4.1 UCLB reserves for itself and UCL the non-exclusive, irrevocable, worldwide, royalty-free right to:

 

  (a) Use the Licensed Technology in the Field for academic research, publication and teaching; and

 

  (b) Grant licences to academic third parties to use the Licensed Technology in academic research collaborations with UCL; and

 

  (c) Grant licences of the Licensed Technology to post graduate students of UCL for the purpose of conducting a programme of post graduate academic research.

In exercising the rights described in Clause 2.4.1(b) and (c), UCL and UCLB shall comply with the provisions of Clause 3 as regards confidentiality of the Know-how.

 

  2.4.2 Except for the licences expressly granted by this Clause 2, UCLB grants no rights to the Licensee (whether under this Agreement or the relevant Licence Addendum) to or under any intellectual property other than the Licensed Technology and hereby reserves all rights under the Licensed Technology outside the Field.

 

  2.4.3 Nothing in this Agreement or any Licence Addendum shall limit or otherwise affect UCL’s ability to apply for non-commercial grant funding or comply with such grant terms and conditions. In the event that any terms of this Agreement or any Licence Addendum conflicts with the terms of any non-commercial grant funding, the Parties shall negotiate in good faith to amend the terms of this Agreement or the relevant Licence Addendum to allow UCL to access such funding provided that nothing herein shall require the Licensee to agree to alter or modify the scope of the licence granted to it in this Clause 2.

 

2.5 Affiliates

The Licensee shall:

 

  2.5.1 ensure that its Affiliates comply fully with the terms of this Agreement;

 

  2.5.2 be responsible for any breach of or non-compliance with this Agreement by its Affiliates as if the breach or non-compliance had been a breach or non-compliance by the Licensee;

 

  2.5.3 indemnify in accordance with Clause 10.6 each of the Indemnitees against any Claims which are awarded against or suffered by any of the Indemnitees as a result of any breach of or non-compliance with this Agreement by its Affiliates; and

 

  2.5.4 ensure that if any Affiliate ceases to be an Affiliate as a result of a change of Control or otherwise, that unless a sub-licence agreement in accordance with Clause 2.3 is entered into with such an Affiliate, such former Affiliate immediately upon such cessation:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (a) ceases developing, manufacturing, having manufactured, using, selling and/ or having sold Licensed Products and ceases all use or exploitation of the Licensed Technologies, for as long as any of the relevant Patents remains in force and/or the Know-how remains confidential;

 

  (b) returns to the Licensee or destroys any documents or other materials in the former Affiliate’s possession or under its control and that contain Confidential Information provided under this Agreement relating to the Licensed Technologies and/ or Licensed Products;

 

  (c) to the extent possible, takes all action necessary to have any product licences, marketing authorisations, pricing and/ or reimbursement approvals (and any applications for any of the foregoing) which relate to Licensed Products transferred into the name of the Licensee.

 

2.6 Option to License Specified Technology

 

  2.6.1 UCLB, where it is free and reasonably able to do so, shall grant to the Licensee an exclusive option to negotiate for a royalty-bearing licence to the Specified Technology on reasonable commercial terms to be negotiated in good faith between the Parties (the “Specified Technology Option”).

 

  2.6.2 The Specified Technology Option in respect of each Specified Technology will be valid and exercisable for a period of 4 years from the Commencement Date (the “Specified Technology Option Period”). If the Licensee wishes to exercise the Specified Technology Option within the Specified Technology Option Period, the Licensee shall serve notice upon UCLB to this effect (the “Specified Technology Option Notice”). UCLB and the Licensee will have a period of up to [***] ([***]) months from the Licensee’s receipt of the Specified Technology Option Notice to negotiate in good faith the commercially reasonable terms of a separate licence agreement governing such licence (the “Specified Technology Negotiation Period”). The Specified Technology Negotiation Period may be extended by mutual agreement of the Parties. If, with respect to any such Specified Technology, either the Licensee does not exercise its Specified Technology Option within the Specified Technology Option Period, or the Licensee and UCLB are unable to agree on the terms of a licence agreement within the Specified Technology Negotiation Period, the Licensee’s rights with respective to such Specified Technology pursuant to this Clause 2.6 shall terminate forthwith.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

3. KNOW-HOW AND CONFIDENTIAL INFORMATION

 

3.1 Provision of Know-how

 

  (a) Within [***] ([***]) days following the effective date of each Licence Addendum, UCLB shall deliver to the Licensee an outline of the Know-how relating to that Licence Addendum and (where applicable) a list of relevant documents.

 

  (b) For the avoidance of doubt, UCLB’s obligations under this Clause 3.1 shall not extend to any Materials. Materials may be provided to the Licensee as the Parties may agree on a case by case basis. Where Materials are provided to the Licensee, they shall be deemed to be Know-how under this Agreement.

 

3.2 Confidentiality of Know-how

The Licensee undertakes that for so long as the Know-how remains confidential, it shall (and shall ensure that its Affiliates and Sub-licensees) take all reasonable precautions to prevent unauthorised access to the Know-how and protect the Know-how in the same manner as it (or they) protect(s) its (or their) own proprietary information, and shall not (and shall ensure that its Affiliates and Sub-licensees do not) use the Know-how for any purpose, except as expressly licensed hereby and in accordance with the provisions of this Agreement. For the avoidance of doubt, to the extent that any Know-how or information relating to the Licensed Technology falls within the public domain (without any breach of this Agreement or any other obligation of confidentiality), then UCL, the Founders and UCLB shall be free to use such information without restriction in the same way that any third party would have the freedom to use it.

 

3.3 Confidentiality Obligations

Each Party (“Receiving Party”) undertakes:

 

  3.3.1 to maintain as secret and confidential all Confidential Information obtained from the other Party (“Disclosing Party”) in the course of or in anticipation of this Agreement and to respect the Disclosing Party’s rights therein;

 

  3.3.2 to use such Confidential Information only for the purposes of or as permitted by this Agreement; and

 

  3.3.3 to disclose such Confidential Information only to those of its employees, contractors, Affiliates, and Sub-licensees (if any) to whom and to the extent that such disclosure is reasonably necessary for the purposes of this Agreement, provided however that the Licensee shall have the right to disclose Confidential Information received from UCLB to (i) potential or actual customers of Licensed Products and/ or Licensed Services to the extent reasonably necessary to promote the sale or use of Licensed Products and/ or Licensed Services and provided that the customer has agreed to confidentiality provisions at least as restrictive as set forth herein.(ii) to existing potential investors or lenders provided that such third parties have agreed to confidentiality provisions at least as restrictive as set forth herein, and, (iii) to its Board of Directors (or similar governing body) and its counsel, accountants and other professional advisers.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

3.4 Exceptions to Obligations

The provisions of Clause 3.3 shall not apply to Confidential Information which the Receiving Party can demonstrate by reasonable written evidence:

 

  3.4.1 was, prior to the Commencement Date, in the possession of the Receiving Party and at its free disposal and was not obtained or otherwise acquired directly or indirectly from the Disclosing Party or its Affiliates or their respective employees, students or representatives; or

 

  3.4.2 is subsequently disclosed to the Receiving Party without any obligations of confidence by a third party; or

 

  3.4.3 is or becomes generally available to the public through no act or default of the Receiving Party or its agents, employees, Affiliates or Sub-licensees; or

 

  3.4.4 the Receiving Party is required to disclose by or to the courts of any competent jurisdiction, or to any government regulatory agency or financial authority, provided that the Receiving Party shall:

 

  (a) inform the Disclosing Party as soon as is reasonably practicable;

 

  (b) at the Disclosing Party’s request and cost seek to persuade the court, agency or authority to have the information treated in a confidential manner, where this is possible under the court, agency or authority’s procedures; and

 

  (c) where the disclosure is unavoidable, limit the disclosure of Confidential information to the minimum extent required by law; or

 

  3.4.5 which a Party is advised by its information officer that it is required to disclose under the Freedom of Information Act 2000 or the Environmental Information Regulations 2004.

 

3.5 Disclosure to Employees

The Receiving Party shall inform all of its employees, contractors, Affiliates and Sub-licensees who have access to any of the Disclosing Party’s Confidential Information to which Clause 3.3 applies, shall make all such employees, contractors, Affiliates and Sub-licensees aware of the obligations of confidence and ensure that all recipients of Confidential Information are bound by obligations of confidence no less onerous than those provided for herein (which it undertakes to enforce and for which it is legally responsible) to those of its subsidiaries, employees, and officers as need to have access thereto wholly necessarily and exclusively for the purposes of this Agreement.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

4. CONFLICT OF INTEREST

The Founders, as employees of UCL and founders of Newco, agree to adhere to UCL’s conflict of interest policy: (http://www.ucl.ac.uk/finance/finance_docs/doi_policy.html).

 

5. CONSIDERATION

Equity in Athena Vision Ltd

 

5.1 On or before the Commencement Date, the Licensee shall provide consideration to UCLB in return for the licences and other rights granted by UCLB to the Licensee under this Agreement by issuing shares in the share capital of the Licensee in accordance with the Shareholders’ Agreement, the Licensee shall:

 

  5.1.1 deliver to UCLB a share certificate in respect of the requisite number of validly issued, fully paid up, ordinary shares in the share capital of the Licensee pursuant to the Shareholders’ Agreement, such share certificate to be issued in the name of UCL Business PLC;

 

  5.1.2 ensure that all necessary resolutions have been passed, and its register of members has been written up, to reflect the issue of shares to UCLB referred to in Clause 5.1.1; and

 

  5.1.3 ensure that the appropriate documents and forms shall be filed with the registrar of companies within the time limits prescribed by statute.

 

5.2 For so long as UCLB holds the necessary percentage of the entire issued share capital of the Licensee as required by the Shareholders’ Agreement, the Licensee shall ensure that:

 

  5.2.1 UCLB shall at all times be entitled (but not bound) to appoint such person as UCLB may from time to time nominate as a director (“UCLB Director”) of the board of directors of the Licensee (the “Board”). The UCLB Director shall have the right to attend (either in person or by any electronic means) and speak at all meetings of the Board and of any committee(s) constituted by the Board, and shall have the right to vote at any such meetings in accordance with the Shareholders’ Agreement for NewCo. UCLB shall at all times have the right to speak at all meetings of the Board and of any committee(s) constituted by the Board and shall have the right to vote at any such meetings in accordance with the Shareholders’ Agreement for NewCo. UCLB shall at all times have the right to remove any UCLB Director and upon his/her removal, to appoint another UCLB Director in his/her place as and when UCLB deems appropriate in its sole and absolute discretion.

 

  5.2.2 At the same time any notice is sent to any director of the Licensee convening a meeting of the Board or any committee constituted by the Board, such notice shall be sent to the relevant UCLB Director together with a written agenda specifying the matters to be raised at the meeting and copies of all documents to be laid before or discussed at the meeting.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  5.2.3 Each UCLB Director shall be at liberty from time to time to make full disclosure to UCLB and its Affiliates of any and all commercial and/or financial information relating to the Licensee. In addition, UCLB and its Affiliates shall be entitled to have prompt and unrestricted access to (i) all trading records and information relating to the operations of the Licensee; (ii) all accounts (including management accounts), books, bank statements, and other financial records of the Licensee; and (iii) all information available to the Licensee concerning any legal or arbitration proceedings threated or commenced against or by the Licensee.

 

5.3 Other Milestone Payments

Within [***] ([***]) days following achievement of each of the following milestone events, the Licensee shall notify UCLB in writing that the relevant milestone event has been achieved, provide documentary evidence of such achievement as appropriate and pay to UCLB, within a period of [***] days, the amount(s) set out next to such milestone event below:

 

Milestone Event

   Amount to be paid

[***]

   £[***]

[***]

   £[***]

 

5.4 Annual Management Fees

On each date referred to in the following table, the Licensee shall pay to UCLB the annual management fee set out next to such date in the table.

 

Date

   Amount to be paid
Upon each anniversary of the Commencement Date until [***]    £50,000

If the Licensee fails to pay any such amount by such date, UCLB may in its sole and absolute discretion either (a) convert the licence granted under Clause 2.1 into a non-exclusive licence or (b) elect to treat such non-payment as a material breach of contract under Clause 11.3.1.

 

5.5 Sales Linked Milestone Payments

Upon achievement of each of the sales linked milestones set out in the following table, the Licensee shall notify UCLB in writing that the relevant sales linked milestone has been achieved, provide the relevant documentary evidence and pay to UCLB the amount(s) set out next to such event in the table:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

Sales Linked Milestones

   Amount to be paid
When Net Sales Value reaches £[***]    £[***]
On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])    £[***]
On the next £[***] of Net Sales Value (When sales cumulatively reach £[***])    £[***]
On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])    £[***]
On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])    £[***]
On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])    £[***]

 

5.6 Royalties on Net Sales

For each Licensed Technology the Licensee shall pay to UCLB a royalty of [***]% ([***] per cent) being a percentage of the Net Sales Value of all Licensed Products or any part thereof.

 

5.7 Royalties on Net Receipts

For each Licensed Technology the Licensee shall pay to UCLB a royalty of [***]% ([***] per cent) being a percentage of Net Receipts

 

5.8 [***]

 

5.9 Combination Products

If any Licensed Products are incorporated in any other product (“Combination Product”) sold by the Licensee or its Affiliates and the Licensed Product is not priced separately from the Combination Product, the Net Sales Value of such Licensed Product shall be deemed to be the fair market value of the Licensed Product in the country of sale when sold separately or if not sold separately in the country of sale, in comparable countries and territories or if neither of the foregoing apply, a reasonable amount which fairly reflects the value of the Licensed Product within the Combination Product assuming the Licensed Product is not being sold as a loss leader.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

5.10 [***]

 

5.11 Payment Frequency

Royalties due under this Agreement, except for Management Fees, Other Milestone payments and Sales Milestone payments, which are payable upon the date specified in Clauses 5.3, 5.4 and 5.5 as appropriate, shall be paid within [***] ([***]) days following the end of each calendar quarter ending on 31 March, 30 June, 30 September and 31 December in each year, in respect of sales of Licensed Products made and Net Receipts generated during such quarter and within [***] ([***]) days following the termination of the relevant Licence Addendum.

 

5.12 Payment terms

All sums due under this Agreement:

 

  5.12.1 are exclusive of Value Added Tax which where applicable will be paid by the Licensee to UCLB in addition;

 

  5.12.2 shall be paid in pounds sterling in cash by transferring an amount in aggregate to the following Account name: UCL Business Plc, Sort Code: 20 10 53, Account number: 30782270, Address: Barclays Bank Plc, PO Box 11345, London, W12 8GG, and in the case of income or amounts received by the Licensee or its Affiliates in a currency other than pounds sterling, the royalty shall be calculated in the other currency and then converted into equivalent pounds sterling at the relevant daily spot rate for that currency as quoted in the Financial Times newspaper on the last business day of the quarter in relation to which the royalties are payable;

 

  5.12.3 will be made without any set-off, deduction or withholding except as may be required by law. If the Licensee is required by law to make any deduction or to withhold any part of any amount due to UCLB under this Agreement, the Licensee will give to UCLB proper evidence of the amount deducted or withheld and payment of that amount to the relevant taxation authority, and will do all things in its power to enable or assist UCLB to claim exemption from or, if that is not possible, to obtain a credit for the amount deducted or withheld under any applicable double taxation or similar agreement from time to time in force; and

 

  5.12.4 shall be made by the due date, failing which UCLB may charge interest on any outstanding amount on a daily basis at a rate equivalent to [***]% above the Bank of England pound sterling base rate then in force in London.

 

5.13 Royalty Statements

The Licensee shall, in respect of each Licensed Technology, send to UCLB at the same time as each royalty payment is made in accordance with Clauses 5.6 and 5.7 a statement setting out for the relevant calendar quarter:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  5.13.1 in respect of each territory or region in which Licensed Products are sold:

 

  (a) the types of Licensed Product sold;

 

  (b) the quantity of each type sold;

 

  (c) the total invoiced price for each type of Licensed Product sold;

 

  (d) where relevant, details of any Licensed Products that have been sold other than on arm’s length terms for a cash consideration, including the relevant open market price or (if not available) the reasonable price attributed thereto;

 

  (e) the amounts deducted from the Net Sales Value as referred to in paragraph (i) to (iv) of that definition (broken down on a product by product and category by category basis); and

 

  (f) the aggregate royalties on Net Sales Value due to UCLB.;

 

  5.13.2 a breakdown of all Net Receipts,

in each case expressed both in local currency and pounds sterling and showing the conversion rates used, during the period to which the royalty payment relates.

 

5.14 Records

In respect of each Licensed Technology:

 

  5.14.1 The Licensee shall keep at its normal place of business detailed and up to date records and accounts showing the quantity, description and invoiced price or non-cash consideration for all Licensed Products sold by it or its Affiliates or on its or its Affiliates’ behalf, and the amount of Net Receipts, broken down in each case on a country by country basis, and being sufficient to ascertain the payments due to UCLB under this Agreement.

 

  5.14.2 The Licensee shall make such records and accounts available, on reasonable notice, for inspection during business hours by an independent chartered accountant nominated by UCLB for the purpose of verifying the accuracy of any statement or report given by the Licensee to UCLB under Clause 5.14.1. The Licensee shall co-operate reasonably with any such accountant, and shall promptly provide all information and assistance reasonably requested by such accountant. The accountant shall be required to keep confidential all information learnt during any such inspection, and to disclose to UCLB only such details as may be necessary to report on the accuracy of the Licensee’s statement or report. UCLB shall be responsible for the accountant’s charges unless the accountant certifies that there is an inaccuracy of more than [***]% ([***] percent) in any royalty statement, in which case the Licensee shall pay his charges in respect of that inspection.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  5.14.3 The Licensee shall ensure that UCLB has the same rights as those set out in this Clause 5.14 in respect of the Licensee’s Affiliates and Sub-licensees.

The Licensee shall co-operate with UCLB in good faith to resolve any discrepancies identified during any such inspection and [***], together with interest on late payment as specified in Clause 5.12.4, within [***] following receipt of a copy of the independent chartered accountant’s report.

 

5.15 Accounting Standards

Where this Agreement requires a financial calculation to be made or an action to be taken, such calculation or action will be made or taken in accordance with the generally accepted accounting principles from time to time approved by the United Kingdom’s Accounting Standards Board, or any successor body, applicable as at the date on which such calculation or action is made or taken.

 

6. COMMERCIALISATION

 

6.1 General Diligence

The Licensee shall in respect of each Licensed Technology, use Diligent Efforts to develop and commercially exploit Licensed Products throughout the Territory (including obtaining all and any regulatory approvals which may be required to market and sell the Licensed Products) and to maximise sales for the benefit of both Parties.

 

6.2 Competing Activities

The Licensee shall notify UCLB in confidence if it or any of its Affiliates or its Sub-licensees commences any marketing, sale or commercialisation of any Competing Product or enters into an agreement with any other person with respect to any such activities.

 

6.3 Development Plan

The current Development Plan for the Licensed Technology is shown in each Licence Addendum (the “Current Development Plan”). Within six (6) months of the Effective Date of the relevant Licence Addendum, the Licensee will provide for each Licensed Technology, an updated plan for developing and commercialising Licensed Products (the “Updated Development Plan”). The Updated Development Plan shall include development milestones events mutually agreed by the Parties and shall form part of the relevant Licence Addendum and this Agreement. The Parties shall negotiate in good faith to reach agreement on such development milestones. In the event that the Licensee fails to provide the Updated Development Plan or the Parties fail to agree development milestones, despite negotiating in good faith, within such six month period, UCLB may in its sole and absolute discretion terminate the relevant Licence Addendum in accordance with Clause 11.5.1. The Licensee shall provide to UCLB on each anniversary of the Effective Date of the relevant Licence Addendum a written update to the Updated Development Plan that shall:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  6.3.1 report on all activities conducted under this Agreement by the Licensee and its Affiliates and Sub-licensees since the Effective Date of the relevant Licence Addendum or the date of the previous update (as appropriate);

 

  6.3.2 (where applicable) set out the milestone events achieved since the Effective Date of the relevant Licence Addendum or the date of the previous update (as appropriate) and the Licensee’s reasonable estimate of the dates for achieving any future milestone events;

 

  6.3.3 set out the current and projected activities being taken or planned to be taken by the Licensee and its Affiliates and Sub-licensees to bring Licensed Products to market, and to maximise the sale of Licensed Products in the Territory; and

 

  6.3.4 set out the Licensee’s projected sales of Licensed Products (based on the Licensee’s current forecasts) for each of the next [***] ([***]) years following the date of the report.

UCLB’s receipt or approval of any update to the Updated Development Plan shall not be taken to waive or qualify the Licensee’s obligations under Clause 6.1.

 

6.4 Annual Meeting

In respect of the Licensed Technology, the Licensee will on UCLB’s request meet with UCLB at least once per calendar year, following the submission of the update to the relevant Development Plan pursuant to Clause 6.3, to discuss progress with development and commercialisation of the Licensed Technology and where relevant the Licensee’s efforts to maximise sales of Licensed Products.

 

6.5 Development Milestones

In addition to the Licensee’s obligations under Clause 6.1, the Licensee shall for each Licensed Technology use Diligent Efforts to achieve the development milestone events specified in the relevant Licence Addendum by the dates set out therein or as later agreed between the Parties in accordance with Clause 6.3, where applicable.

 

6.6 Reporting of First Commercial Sale

The Licensee will, for each Licenced Technology, promptly notify UCLB in writing of the first commercial sale of each Licensed Product in each country within the Territory.

 

6.7 Reporting for Impact Purposes

 

  6.7.1 The Licensee acknowledges that part of UCLB’s purpose in licensing the Licensed Technologies to the Licensee pursuant this Agreement is to ensure that the Licensed Technologies are made available for use and commercial exploitation with the intention of benefitting society and the economy. In order to enable UCLB and UCL to monitor the benefit that they are providing, and to enable UCL to demonstrate the impact of its research activities, to society and the economy, the Licensee will upon request provide to UCLB [***], a written report describing in reasonable detail how it has used each Licensed Technology, and the societal and economic benefits generated therefrom.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  6.7.2 UCLB shall notify and seek permission from the Licensee in advance, in writing if it wishes to use any written reports received from the Licensee (and the information contained therein) pursuant to Clause 6.7.1 in applications for research or other grant related funding and in submissions to Higher Education funding bodies such as HEFCE and/ or HEIF (or any replacements for either of those entities) and like entities, supplying a written copy of the application for research or other grant related funding or submission (or the relevant sections thereof). The Licensee will respond to UCLB in writing within [***] ([***]) days of receipt of such written information and subject to the removal of any confidential information as notified in such written request by the Licensee, UCLB and UCL shall be entitled to submit the approved applications for research or other grant related funding and in submissions to Higher Education funding bodies such as HEFCE and/or HEIF (or any replacements for either of those entities) and like entities.

 

6.8 Quality

The Licensee shall ensure that all of the Licensed Products marketed by it and its Affiliates and Sub-licensees are of satisfactory quality and comply with all applicable laws and regulations in each part of the Territory.

 

6.9 Marking of Licensed Products

To the extent permitted under the laws of any country, the Licensee shall mark and cause its Affiliates and Sub-Licensees to mark each Licensed Product with the number of each issued Patent which applies to the Licensed Product and a statement that such Licensed Products are sold under licence from UCL Business plc.

 

6.10 Disposals of Licensed Products for Free

Notwithstanding the terms of Clause 6.1, the Licensee shall be entitled to supply a reasonable number of Licensed Products to third parties free of charge as promotional items for the purpose of establishing a market for the Licensed Products in the relevant country or territory or for evaluation and testing purposes, provided that the quantity of Licensed Products supplied for free in each country or territory is not excessive and is in line with normal industry practice in such country or territory. Any Licensed Products disposed of to third parties free of charge in accordance with this Clause 6.10 shall not be taken into account for the purposes of calculating Net Sales Value.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

6.11 Referral to Expert

If UCLB considers at any time during the period of this Agreement that the Licensee has failed to comply with its obligations under Clause 6.1, 6.3 or 6.5 in relation to any Licenced Technology, then the matter shall be referred to an independent expert to answer the following questions:

 

  6.11.1 whether the Licensee has complied with its obligations under Clause 6.1, 6.3 or 6.5 in relation to the relevant Licensed Technology; and if not

 

  6.11.2 what specific action the Licensee should have taken and/or now needs to take (“Specific Action”) in order to fulfil such obligations and within what period the Specific Action should be taken (“Action Period”).

The independent expert shall be appointed in accordance with the provisions of Schedule 2 and his decision shall be final and binding on the Parties.

 

6.12 Consequences of Expert’s Decision

If the expert determines that the Licensee has failed to comply with its obligations under Clause 6.1, 6.3 or 6.5 in relation to the relevant Licensed Technology, and if the Licensee fails to take the Specific Action within the Action Period, UCLB shall be entitled, by giving, at any time within [***] ([***]) months after the end of that Action Period, not less than [***] ([***]) months’ notice, to (a) convert the licence granted under the relevant Licence Addendum into a non-exclusive licence or (b) terminate the relevant Licence Addendum in accordance with Clause 11.5.2.

 

7. ACCESS TO MEDICINES AND ETHICAL LICENSING

 

7.1 General Diligence

The Licensee agrees to use Diligent Efforts to develop and commercially exploit Licensed Products in a manner consistent with ethical and socially responsible licensing principles, including requiring all Sub-licensees and other parties involved in the development and commercial exploitation of Licensed Products to agree in writing to comply with ethical and socially responsible licensing principles.

 

7.2 Supply to Developing Countries

 

  7.2.1 Supply by the Licensee

The Licensee shall use Diligent Efforts to supply the Licensed Products to customers in At-Cost Markets at a Cost-Based Price and to meet market demand for the Licensed Products in those markets.

 

  7.2.2 Sub-Licensing in Developing Country markets

If the Licensee is unable to supply the Licensed Product at a Cost-Based Price in any At-Cost market and to meet market demand for the Licensed Products in those market, it shall use Diligent Efforts to license one or more Developing Country Manufacturers on Reasonable Developing Country License Terms to manufacture, distribute and sell the Licensed Product at a Cost-Based Price in that At-Cost Market.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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7.3 Reporting

The Licensee shall keep UCLB regularly updated regarding the Licensee’s efforts to supply the Licensed Products in accordance with the requirements outlined in Clauses 7.1 and 7.2.

 

7.4 Step In Rights

 

  7.4.1 If at any time UCLB acting reasonably considers that the Licensee is not meeting its obligations under Clauses 7.1 and 7.2 in relation to the supply of the Licensed Products to customers in At-Cost Markets, UCBL may be written notice require the Licensee to seek one or more third parties to develop, commercialise and supply the Licensed Products to customers in At-Cost Markets.

 

  7.4.2 If the Licensee following a written requirement from UCLB refuses to grant a sublicense to or is unable to identify a third party to develop, commercialise and supply the Licensed Products to customers in At-Cost Markets, then UCLB notwithstanding the rights granted to the Licensee under this Agreement shall have the right to seek a third party and/ or to grant to a third party a license to manufacture, have manufactured, use, sell, offer for sale and import the Licensed Products for supply in the At-Cost market on Reasonable Developing Country License Terms.

 

8. COMPLIANCE WITH LAWS

 

8.1 General Compliance with Laws

The Licensee will at all times (and will ensure its Affiliates and Sub-licensees) comply with all legislation, rules, regulations and statutory requirements applying to and obtain any consents necessary for its use of each Licensed Technology, the development, manufacture, and sale of Licensed Products and the provision of Licensed Services in any country or territory.

 

8.2 Bribery Act

The Licensee shall (and shall procure that any persons associated with it engaged in the performance of this Agreement including its Affiliates and Sub-licensees shall):

 

  8.2.1 comply with all applicable laws and codes of practice relating to anti-bribery and anti-corruption including the Bribery Act 2010 and without prejudice to the foregoing generality, shall not engage in any activity, practice or conduct which would constitute an offence under sections 1, 2 or 6 of the Bribery Act 2010 or do or omit to do any act that will cause or lead UCLB to be in breach of the Bribery Act 2010;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  8.2.2 comply with UCLB’s ethics, anti-bribery and anti-corruption policies as notified to the Licensee from time to time and have, maintain in place and enforce throughout the term of this Agreement adequate procedures to ensure compliance with Clause 8.2.1; and

 

  8.2.3 promptly report to UCLB any request or demand for any undue financial or other advantage of any kind received in connection with the performance of this Agreement.

For the purpose of this Clause 8.2, the meaning of adequate procedures and whether a person is associated with another person shall be determined in accordance with the Bribery Act 2010 (and any guidance issued under section 9 of that Act). Breach of this Clause 8.2 shall be deemed a material breach of this Agreement entitling UCLB to terminate under Clause 11.3.1.

 

8.3 Export Control Regulations

The Licensee shall ensure that, in using the Licensed Technologies and in selling Licensed Products, it and its Affiliates, employees, sub-contractors and Sub-licensees comply fully with any United Nations trade sanctions or EU or UK legislation or regulation, from time to time in force, which impose arms embargoes or control the export of goods, technology or software, including weapons of mass destruction and arms, military, paramilitary and security equipment and dual-use items (items designed for civil use but which can be used for military purposes) and certain drugs and chemicals.

 

9. INTELLECTUAL PROPERTY

 

9.1 Obtain and Maintain the Patents

 

  9.1.1 The Licensee shall be responsible for the drafting, filing, prosecution and maintenance of all of the Patents for each Licenced Technology exclusively licensed to the Licensee subject to Clause 2.4, at the Licensee’s cost and expense. Subject to resource availability, UCLB shall use commercially reasonable efforts to provide such assistance as the Licensee may request to prosecute and maintain the Patents[***] that may be incurred in providing such assistance. For the avoidance of doubt, the provisions of this Clause 9 shall also extend to any patents filed in respect of the Specified Technology pursuant to Clause 2.6 after the Commencement Date.

 

  9.1.2 The Patents for each Licensed Technology will be filed, prosecuted and maintained in the countries and territories set out in Appendix 2 to the relevant Licence Addendum. The Licensee shall notify UCLB of any decisions as to which (if any) additional countries to file and maintain Patents in.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  9.1.3 The Licensee shall consult with UCLB in relation to all material changes to the patent claims or specifications that would have the effect of reducing or limiting the scope of the Patents, and not make any such changes without the prior written consent of UCLB. Such consent shall not be unreasonably withheld or delayed provided that UCLB has been given as much notice as is practicable, and in any event no less than [***] days’ notice (or such shorter period for response dictated by the relevant patent office) of such proposed changes, and has been given an opportunity to file divisionals, continuations and/or such other types of protection to cover any claims or subject matter that the Licensee intends to remove from the scope of the Patents. If UCLB fails to respond before the end of the [***] day period (or such shorter period for response dictated by the relevant patent office), the Licensee may proceed with the proposed changes to the patent claims or specifications. The Licensee will ensure that UCLB receives copies of all correspondence to and from Patent Offices in respect of the Patents for each Licensed Technology, including copies of all documents generated in or with such correspondence, and shall be given reasonable notice (or such shorter period for response dictated by the relevant patent office) of and the opportunity to participate in any conference calls or meetings with the Licensee’s patent attorneys in relation to the drafting, filing, prosecution and maintenance of the Patents, so that UCLB may be continuously informed of progress with the drafting, filing, prosecution and maintenance of the Patents. Such involvement of UCLB under this Clause 9.1.3 shall be at UCLB’s cost and expense.

 

  9.1.4 If the Licensee wishes to abandon any application contained with the Patents for any Licensed Technology or not to maintain any such Patent, it shall give [***] ([***]) months’ prior written notice to UCLB and on the expiry of such notice period the relevant Licence Addendum shall terminate and the licences of the relevant Patents granted to the Licensee under this Agreement shall cease.

 

  9.1.5 In the event that any of rights to the Licenced Technology granted hereunder become non-exclusive, responsibility for the drafting, filing, prosecution and maintenance of all of the Patents for such Licenced Technology shall revert to UCLB.

 

9.2 Infringement of the Patents

 

  9.2.1 Each Party shall inform the other Party promptly if it becomes aware of any infringement or potential infringement of any of the Patents for each Licensed Technology in the relevant Field or any unauthorised use of the Know-how or any challenge to the validity or ownership of the Patents, and the Parties shall consult with each other to decide the best way to respond to such infringement, unauthorised use or challenge.

 

  9.2.2 In relation to each Patent exclusively licensed to the Licensee subject to Clause 2.4, the Licensee shall have the primary obligation and right to take action against any third party alleged to be infringing the Patents for each Licensed Technology or making unauthorised use of the Know-how to defend the Patents against challenges to validity or ownership at its sole expense, provided that:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (a) UCLB shall on the Licensee’s request cooperate with the Licensee in such action [***]; and

 

  (b) subject to Clauses 9.2.3 and 9.2.5, the Licensee shall be solely responsible for the conduct of the action or for settlement thereof and shall be entitled to all damages received from such action, subject to Clause 9.2.4.

 

  9.2.3 Before starting or defending or settling any legal action under Clause 9.2.2, the Licensee shall consult with UCLB as to the advisability of the action or defence or settlement, its effect on the good name of UCLB, the public interest, and how the action or defence should be conducted. .

 

  9.2.4 The Licensee shall [***] in such action or defence.

 

  9.2.5 UCLB shall if reasonably requested by the Licensee agree to be joined in any suit to enforce such rights or will take such action in its own name [***] and shall have the right to be separately represented by its own counsel [***]. Notwithstanding the foregoing, [***].

 

  9.2.6 If the Licensee is unsuccessful in persuading the alleged infringer to desist within [***] ([***]) months of the Licensee first becoming aware of any potential infringement of the Patents for any Licensed Technology or fails to initiate an infringement action within [***] ([***]) months of becoming aware of such infringement, UCLB shall have the right, at its sole discretion, to prosecute such infringement under its sole control [***].

 

9.3 Infringement of Third Party Rights

 

  9.3.1 If any warning letter or other notice of infringement is received by a Party, or legal suit or other action is brought against a Party, alleging infringement of third party rights in the manufacture, use or sale of any Licensed Product or use of any Patents or any Licensed Technology, that Party shall promptly provide full details to the other Party, and the Parties shall discuss the best way to respond.

 

  9.3.2 In relation to each Patent exclusively licensed to the Licensee, the Licensee shall have the right but not the obligation to defend such suit to the extent it relates to the Licensee’s or its Affiliates or Sub-licensee’s activities in the relevant Field and shall have the right to settle with such third party, provided that [***].

 

10. WARRANTIES AND LIABILITY

 

10.1 Warranties by UCLB

UCLB warrants and undertakes as follows in respect of each Licensed Technology and subject to any disclosures and exceptions set out in the relevant Licence Addendums, to its reasonable knowledge and without having undertaken any due and careful enquires whether specific or general in nature:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  10.1.1 it is the registered proprietor of, or applicant for, the relevant Patents; and

 

  10.1.2 it has the authority to grant the licences under this Agreement and the relevant Licence Addendum.

 

  10.1.3 so far as it is aware (having made no enquiry of any third parties or conducted any freedom to operate searches), use and exploitation of the Patents will not infringe the intellectual property rights of any third party.

 

10.2 Warranties by the Licensee

The Licensee warrants and undertakes that in respect of the Licensed Technology:

 

  10.2.1 it has the right and authority to enter into this Agreement and the relevant Licence Addendum;

 

  10.2.2 so far as it is aware (having made no enquiry of any third parties), use and exploitation of the Patents will not infringe the intellectual property rights of any third party;

 

  10.2.3 neither it nor any of its Affiliates is currently researching, developing, marketing, selling or otherwise commercialising any Competing Product (“Competing Activities”), nor has any of them entered into an agreement with any other person with respect to any Competing Activities; and

 

  10.2.4 it shall notify UCLB if it or any of its Affiliates or its Sub-licensees commences any Competing Activities or enters into an agreement with any other person with respect to any Competing Activities.

 

10.3 Acknowledgements

The Licensee acknowledges that in respect of each Licensed Technology:

 

  10.3.1 the Licensed Technology, including inventions claimed in the Patents, and the Know-how, are at an early stage of development. Accordingly, specific results cannot be guaranteed and any results, materials, information or other items (together “Delivered Items”) provided under this Agreement are provided “as is” and without any express or implied warranties, representations or undertakings. As examples, but without limiting the foregoing, UCLB does not give any warranty that Delivered Items are of merchantable or satisfactory quality, are fit for any particular purpose, comply with any sample or description, or are viable, uncontaminated, safe or non-toxic.

 

  10.3.2 UCLB has not performed any searches or investigations into the existence of any third party rights that may affect the relevant Licensed Technology.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

10.4 No Other Warranties

 

  10.4.1 Each of the Parties acknowledges that, in entering into this Agreement, it does not do so in reliance on any representation, warranty or other provision except as expressly provided in this Agreement, and any conditions, warranties or other terms implied by statute or common law are excluded from this Agreement to the fullest extent permitted by law.

 

  10.4.2 Without limiting the scope of Clause 10.4.1, UCLB does not make any representation nor give any warranty or undertaking:

 

  (a) as to the efficacy or usefulness of the Licensed Technologies; or

 

  (b) as to the scope of any of the Patents or that any of the Patents is or will be valid or (in the case of an application) will proceed to grant; or

 

  (c) that the use of any of the Licensed Technologies, the manufacture, sale or use of the Licensed Products, or the exercise of any of the rights granted under this Agreement will not infringe any intellectual property or other rights of any other person; or

 

  (d) that the Know-how or any other information communicated by UCLB to the Licensee under or in connection with this Agreement will produce Licensed Products of satisfactory quality or fit for the purpose for which the Licensee intended or that any product will not have any defect, latent or otherwise, and whether or not discoverable by inspection; or

 

  (e) as imposing any obligation on UCLB to bring or prosecute actions or proceedings against third parties for infringement or to defend any action or proceedings for revocation of any of the Patents; or

 

  (f) as imposing any liability on UCLB in the event that any third party supplies Licensed Products to customers located in the Territory; or

 

  (g) that there will be no similar or competitive products manufactured, used, sold or supplied by any third party in the Territory.

 

10.5 Responsibility for Development of Licensed Products and Licensed Services

The Licensee shall be exclusively responsible for its and its Affiliates’ and Sub-licensees’ use of the Licensed Technology, the technical and commercial development and manufacture of Licensed Products and for incorporating any modifications or developments thereto that may be necessary or desirable, for all Licensed Products sold or supplied, notwithstanding any consultancy services or other contributions that UCLB and/or UCL may provide in connection with such activities.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

10.6 Indemnity

The Licensee shall indemnify each of UCLB and UCL, and each of their respective officers, directors, Council members, employees and representatives (together, the “Indemnitees”) against all Claims that may be asserted against or suffered by any of the Indemnitees and which relate to:

 

  10.6.1 the use by the Licensee or any of its Affiliates or Sub-licensees of any of the Licensed Technology; or

 

  10.6.2 use of the Licensed Technology by or on behalf of the Licensee or any of its Affiliates or Sub-licensees; or

 

  10.6.3 the development, manufacture, use, marketing or sale of, or any other dealing in, any of the Licensed Products, by or on behalf of the Licensee or any of its Affiliates or Sub-licensees, or subsequently by any customer or any other person, including claims based on product liability laws.

The indemnity given by the Licensee to each Indemnitee under this Clause will not apply to any Claim to the extent that it is attributable to the gross negligence, reckless misconduct or intentional misconduct of that Indemnitee.

 

10.7 Limitations of Liability

 

  10.7.1 To the extent that UCLB or any of its Affiliates has any liability in contract, tort, or otherwise under or in connection with this Agreement, including any liability for breach of warranty, their liability shall be limited in accordance with the following provisions of this Clause 10.7.

 

  10.7.2 The aggregate liability of UCLB and any of its Affiliates shall be limited to the total income that UCLB has received from the Licensee pursuant to this Agreement (but excluding any other costs or expenses associated with drafting, filing, prosecuting, maintaining or defending any Patents or providing any assistance to the Licensee) during the period of [***] ([***]) years preceding the date on which the liability arises, or [***] pounds (£[***]) sterling, whichever is the higher.

 

  10.7.3 The liability of the Licensee shall be limited to the limit of its insurance as set out in Clause 10.8.1, except that in the case of product liability, the liability of the Licensee under this Agreement shall be unlimited.

 

  10.7.4 In no circumstances shall either Party or any Indemnitee be liable for any loss, damage, costs or expenses of any nature that is (a) of an indirect, special or consequential nature or (b) any loss of profits (whether direct or indirect), revenue, business opportunity or goodwill, which arises directly or indirectly from that Party’s breach or non performance of this Agreement, or negligence in the performance of this Agreement or from any liability arising in any other way out of the subject matter of this Agreement even if the Party bringing the claim has advised the other Party or the relevant Indemnitee of the possibility of those losses arising, or if such losses were within the contemplation of the Parties or the Indemnitee.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  10.7.5 Nothing in this Agreement excludes either Party’s liability to the extent that it may not be so excluded under applicable law, including any such liability for death or personal injury caused by that Party’s negligence, or liability for fraud or fraudulent misrepresentation.

 

10.8 Insurance

 

  10.8.1 The Licensee shall take out with a reputable insurance company and maintain at all times during the term of this Agreement public and product liability and professional indemnity insurance including against all loss of and damage to property (whether real, personal or intellectual) and injury to persons including death arising out of or in connection with this Agreement and the Licensee’s and its Affiliates’ and Sub-licensees’ use of the Licensed Technology and as and when relevant use, sale of or any other dealing in any of the Licensed Products. Such insurances may be limited in respect of one claim provided that such limit must be at least [***] pounds (£[***]) sterling, unless the Licensee commences any business in manufacturing, distribution, supply or otherwise make available to the public any products, in which case such limit must be at least [***] pounds (£[***]) sterling. Such insurance shall continue to be maintained for a further [***] years from the end of the last Licence Addendum hereunder to terminate.

 

  10.8.2 The Licensee will produce to UCLB at all times upon demand proof that the insurance cover required pursuant to Clause 10.8.2 is in force and evidence that all premiums have been paid up to date. If UCLB becomes aware that the Licensee has failed to maintain the insurance required pursuant to Clause 10.8.2 UCLB may effect such insurance and the Licensee will reimburse UCLB for the reasonable cost of effecting and maintaining such insurance on demand.

 

11. DURATION AND TERMINATION

 

11.1 Commencement and Termination by Expiry (General)

This Agreement (excluding the Licence Addendums) shall come into effect on the Commencement Date and, unless terminated earlier in accordance with this Clause 11 or Clause 12.1.2, shall continue in force until the date on which the last Licence Addendum entered into hereunder has expired or terminated.

 

11.2 Commencement and Termination by Expiry (Licence Addendums)

[***].

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

11.3 Early Termination (General)

Each Party (the “Terminating Party”) may terminate this Agreement at any time by notice in writing to the other Party (“Other Party”), such notice to take effect as specified in the notice:

 

  11.3.1 if the Other Party is in material breach of this Agreement and, in the case of a breach capable of remedy within thirty (30) days, the breach is not remedied within thirty (30) days of the Other Party receiving notice specifying the breach and requiring its remedy or where the breach relates to non-payment of a sum due under this Agreement, the sum is not paid in full within fourteen (14) days following the Other Party receiving notice specifying the non payment and requiring payment in full; or

 

  11.3.2 if:

 

  (a) the Other Party becomes insolvent or unable to pay its debts as and when they become due;

 

  (b) an order is made or a resolution is passed for the winding up of the Other Party (other than voluntarily for the purpose of solvent amalgamation or reconstruction);

 

  (c) a liquidator, administrator, administrative receiver, receiver or trustee is appointed in respect of the whole or any part of the Other Party’s assets or business;

 

  (d) the Other Party makes any composition with its creditors;

 

  (e) the Other Party ceases to continue its business; or

 

  (f) any event analogous to the events referred to in paragraphs (a) to (e) above occurs in any other jurisdiction.

The Terminating Party may, at its discretion, choose not to terminate any or all of the Licence Addendums notwithstanding termination of this Agreement, by specifying such in its notice to the Other Party when terminating this Agreement. The relevant terms of this Agreement shall continue in force thereafter to the extent necessary to give effect to the terms of any Licence Addendum(s) which are not terminating until the last such Licence Addendum either expires or is terminated.

 

11.4 UCLB may terminate this Agreement by giving written notice to the Licensee, such termination to take effect forthwith or as otherwise stated in the notice:

 

  11.4.1 if there is any change of Control of the Licensee involving the categories of persons or Affiliates of persons prohibited by Clause 2.3; or

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  11.4.2 the Licensee is in persistent breach of the Agreement and where the Parties have failed to agree a mechanism to remedy the persistent nature of such breaches within a reasonable period following UCLB notifying the Licensee of the persistent breach and requesting that the Licensee enters into discussions with UCLB as to mechanisms for remedying the persistent breaches or if the Parties have agreed a mechanism to remedy the persistent breach but that mechanism if not fully complied with by the Licensee; or

 

  11.4.3 the Licensee is in material breach of the Agreement more than twice in any 24 month period, even if said breaches have been remedied; or

 

  11.4.4 if the Licensee or its Affiliate commences legal proceedings, or assists any third party to commence legal proceedings, to challenge the validity or ownership of any of the Patents; or

 

  11.4.5 if the Licensee shall enter into any sub-licence with any of the categories of persons or Affiliates of persons prohibited by Clause 2.3 which may, adversely affect UCL’s and/or UCLB’s reputation; or

 

  11.4.6 if the Licensee is in material breach of the Shareholders’ Agreement, and said breach is not remedied within 30 days of UCLB notifying the Licensee of said breach and the remedial actions required (acting reasonably) as the case may be.

UCLB may, at its discretion, choose not to terminate any or all of the Licence Addendums notwithstanding termination of this Agreement, by specifying such in its notice to the Licensee when terminating this Agreement. The relevant terms of this Agreement shall continue in force thereafter to the extent necessary to give effect to the terms of any Licence Addendum(s) which are not terminating until the last such Licence Addendum either expires or is terminated.

 

11.5 Early Termination (Licence Addendums)

 

  11.5.1 Each Party may terminate each Licence Addendum (separately from this Agreement or any other Licence Addendum) at any time by notice in writing to the Other Party, such notice to take effect as specified in the notice, if the Other Party is in material breach of the relevant Licence Addendum and, in the case of a breach capable of remedy within thirty (30) days, the breach is not remedied within thirty (30) days of the Other Party receiving notice specifying the breach and requiring its remedy, or where the breach relates to non-payment of a sum due under the relevant Licence Addendum, the sum is not paid in full within fourteen (14) days following the Other Party receiving notice specifying the non-payment and requiring payment in full.

 

  11.5.2 UCLB may terminate each Licence Addendum (separately from this Agreement or any other Licence Addendum) by giving written notice to the Licensee, such termination to take effect forthwith or as otherwise stated in the notice:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (a) if the Licensee fails to achieve any of the milestone events described in the Licensed Addendums provided that if achievement of any of the milestone events should be compromised due to technical, legal or regulatory issues, the Parties shall first meet and UCLB will work with the Licensee to manage the delivery schedule and provided that the Licensee is using Diligent Efforts to correct the issues, the applicable deadline in the relevant Licence Addendum shall be extended by six (6) months or such other time period as shall be agreed between the Parties in writing after which if the Licensee has not achieved the milestone UCLB shall be entitled, subject to Clauses 6.11 and 6.12, to terminate the Licence Addendum by giving written notice to the Licensee; or;

 

  (b) if the Licensee is in persistent breach of the relevant Licence Addendum and where the Parties have failed to agree a mechanism to remedy the persistent nature of such breaches within a reasonable period following UCLB notifying the Licensee of the persistent breach and requesting that the Licensee enters into discussions with UCLB as to mechanisms for remedying the persistent breaches or if the Parties have agreed a mechanism to remedy the persistent breach but that mechanism if not fully complied with by the Licensee;

 

  (c) if the Licensee is in material breach of the relevant Licence Addendum more than twice in any 24 month period, even if said breaches have been remedied;

 

  (d) in accordance with the provisions of Clauses 6.12 or 9.1;

 

  (e) if the Licensee or its Affiliate or its Sub-licensee commences legal proceedings, or assists any third party to commence legal proceedings, to challenge the validity or ownership of any of the Patents; or

 

  (f) in accordance with any other provision as may be specified in the relevant Licence Addendum.

 

11.6 A Party’s right of termination under this Agreement, and the exercise of any such right, shall be without prejudice to any other right or remedy (including any right to claim damages) that such Party may have in the event of a breach of contract or other default by the other Party.

 

11.7 Consequences of Termination (General)

 

  11.7.1 Upon termination or expiry of this Agreement howsoever arising:

 

  (a) all Licence Addendums shall terminate forthwith; and

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  (b) each Party shall upon the written request of the other Party, return or destroy any documents or other materials that are in its or its Affiliates possession or under its or their control and that contain the other Party’s Confidential Information provided always that each Party and its Affiliates shall be entitled to retain such Confidential Information of the other Party that relates to any Licence Addendum that is not terminating at the same time as the rest of this Agreement until termination or expiry of the relevant Licence Addendum.

 

  11.7.2 Upon termination of this Agreement for any reason the provisions of Clauses 1, 2.3, 2.5, 3.2 to 3.5, 4, 5 (in respect of amounts paid and payable to UCLB in respect of the period up to an including the date of termination), 6.7, 8, 10, 11.6, 11.7, 11.8 and 12 of this Agreement shall remain in force.

 

11.8 Consequences of Termination (Licence Addendums).

 

  11.8.1 Upon expiry of each Licence Addendum, and subject to all royalties and any other sums due to UCLB in respect of the Licensed Technology having been duly paid, the Licensee shall have a fully paid up licence to the Licensed Technology of the same scope as set forth in Clause 2.1 without any further obligation to pay any further sums to UCLB under Clause 5. Notwithstanding the foregoing the Licensee acknowledges that once each Patent expires or is abandoned or withdrawn or allowed to lapse in any country or territory, third parties in that country or territory will be entitled to use the inventions claimed in the relevant Patent and that accordingly the relevant licence granted to the Licensee will no longer be exclusive in that country or territory.

 

  11.8.2 Upon termination of each Licence Addendum for any reason other than as set forth in Clause 11.2:

 

  (a) the Licensee and its Affiliates and Sub-licensees shall be entitled to sell, use or otherwise dispose of (subject to payment of royalties under Clause 5) any unsold or unused stocks of the relevant Licensed Products for a period of [***] ([***]) months following the date of termination;

 

  (b) subject to paragraph (a) above, any license that has not become fully paid-up in accordance with Clause 11.8.1 shall terminate and the Licensee and its Affiliates (and subject to Clause 2.3, its Sub-licensees) shall no longer be licensed to use or otherwise exploit the relevant Licensed Technology, in so far and for as long as any of the relevant Patents remains in force and the relevant Know-how remains confidential;

 

  (c) the Licensee shall consent to the cancellation of any formal licence granted to it, or of any registration of it in any register, in relation to any of the relevant Patents;

 

  (d) the Licensee will, promptly on UCLB’s request, provide (and will ensure that its patent agents provide) to UCLB all information, documentation and assistance (including executing documents) which UCLB may reasonably require to enable it to continue with the drafting, filing, prosecution and maintenance of the relevant Patents;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  (e) except as set out in Clause 2.3, all sub-licences of the relevant Licensed Technology granted by the Licensee will automatically terminate;

 

  (f) each Party shall upon the written request of the other Party, return or destroy any documents or other materials that are in its or its Affiliates possession or under its or their control and that contain the other Party’s Confidential Information which relates to the relevant Licensed Technology;

 

  11.8.3 Upon termination by expiry of each Licence Addendum under Clause 11.2, UCLB and its Affiliates shall be free to disclose the Know-how licensed under such Licence Addendum to third parties.

 

  11.8.4 Upon termination of each Licence Addendum under Clause 11.5 by UCLB or as a result of termination of this Agreement under Clause 11.3 by UCLB, in the event that UCLB would be unable, absent a licence from the Licensee, to use or permit others to use or to exploit or permit others to exploit the relevant Licensed Technology without infringing intellectual property rights in any invention developed by the Licensee, whether solely or jointly with others (“Blocking Invention”), the Licensee shall be deemed to have granted UCLB the irrevocable non-exclusive right to use, exploit and permit others to use and exploit the Blocking Invention only in conjunction with the relevant Licensed Technology. The Licensee shall at the request of UCLB provide (and will ensure that its patent agents provide) to UCLB all information, documentation and assistance (including executing documents) which UCLB may reasonably require to enable it to continue with the drafting, filing, prosecution and maintenance of the Patents licensed under such Licence Addendum;

 

  11.8.5 Upon termination of each Licence Addendum under Clause 11.5 by UCLB or as a result of termination of this Agreement under 11.3 by UCLB, the Licensee shall, to the extent it is able to do so without being in breach of any obligation owed to a third party, disclose to UCLB full details of any and all Intellectual Property generated at any time by or on behalf of the Licensee as a result of the exercise of the Licensee’s rights under this Licence Addendum (“Licensee IP”) and, upon UCLB’s written request within [***] ([***]) days following such disclosure, negotiate in good faith to agree the terms of an exclusive or non-exclusive licence to UCLB (as UCLB may request) under the Licensee IP. If the Parties fail to agree the terms of such a licence within [***] days following commencement of such negotiation, despite negotiating in good faith, UCLB’s rights under this Clause 11.8.5 shall lapse.

 

  11.8.6 Upon termination of each Licence Addendum for any reason the provisions of Clauses 1, 3 (in respect of amounts paid and payable to UCLB in respect of the period up to an including the date of termination) and 5 of the Licence Addendum shall remain in force.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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12. GENERAL

 

12.1 Force Majeure

 

  12.1.1 Any delays in or failure of performance by either Party under this Agreement will not be considered a breach of this Agreement and if and to the extent that such delay or failure is caused by occurrences beyond the reasonable control of that Party including acts of God; acts, regulations and laws of any government; strikes or other concerted acts of workers; fire; floods; explosions; riots; wars; rebellion; and sabotage; and any time for performance hereunder will be extended by the actual time of delay caused by any such occurrence.

 

  12.1.2 If either Party is prevented from carrying out its obligations:

 

  (a) under this Agreement for a continuous period of [***] ([***]) months the other Party may terminate this Agreement on giving [***] ([***]) days prior written notice provided always that at the date upon which termination becomes effective the Party which was prevented from carrying out its obligations under this Agreement remains so prevented. The Terminating Party may, at its discretion, choose not to terminate any or all of the Licence Addendum notwithstanding termination of this Agreement, by specifying such in its notice when terminating this Agreement. The relevant terms of this Agreement shall continue in force thereafter to the extent necessary to give effect to the terms of any Licence Addendum(s) which are not terminating until the last such Licence Addendum either expires or is terminated.

 

  (b) under any Licence Addendum for a continuous period of [***] ([***]) months the other Party may terminate the relevant Licence Addendum on giving [***] ([***]) days prior written notice provided always that at the date upon which termination becomes effective the Party which was prevented from carrying out its obligations under the relevant Licence Addendum remains so prevented.

 

12.2 Amendment

This Agreement may only be amended in writing signed by duly authorised representatives of UCLB and the Licensee.

 

12.3 Assignment and Third Party Rights

 

  12.3.1 Subject to Clause 12.3.2, neither Party shall assign, mortgage, charge or otherwise transfer any rights or obligations under this Agreement, nor any of the rights under the Licensed Technology, without the prior written consent of the other Party.

 

  12.3.2 UCLB may assign all its rights and obligations under this Agreement together with its rights in the Licensed Technology to any third party to which it transfers all or substantially all of its assets or business in the relevant Field, provided that the assignee undertakes to the Licensee to be bound by and perform the obligations of the assignor under this Agreement.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  12.3.3 The Licensee, subject to obtaining the consent of UCLB which shall not be unreasonably withheld or delayed (except in relation to those categories of persons or Affiliates of persons prohibited by Clause 2.3), may assign all its rights and obligations under this Agreement together with its rights in the Licensed Technology to any third party to which it transfers all or substantially all of its assets or business, provided that the assignee undertakes to UCLB to be bound by and perform the obligations of the assignor under this Agreement. However the Licensee shall not have such a right to assign this Agreement if it is insolvent..

 

12.4 Waiver

Any waiver given under or in relation to this Agreement shall be in writing and signed by or on behalf of the relevant Party. No failure or delay on the part of either Party to exercise any right or remedy under this Agreement shall be construed or operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude the further exercise of such right or remedy.

 

12.5 Invalid Clauses

If any provision or part of this Agreement is held to be invalid, amendments to this Agreement may be made by the addition or deletion of wording as appropriate to remove the invalid part or provision but otherwise retain the provision and the other provisions of this Agreement to the maximum extent permissible under applicable law.

 

12.6 No Agency

Neither Party shall act or describe itself as the agent of the other, nor shall it make or represent that it has authority to make any commitments on the other’s behalf.

 

12.7 Interpretation

In this Agreement:

 

  12.7.1 the headings are used for convenience only and shall not affect its interpretation;

 

  12.7.2 references to persons shall include incorporated and unincorporated persons; references to the singular include the plural and vice versa; and references to the masculine include the feminine;

 

  12.7.3 references to Clauses and Schedules mean clauses of, and schedules to, this Agreement;

 

  12.7.4 references in this Agreement to termination shall include termination by expiry;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  12.7.5 where the word “including” is used it shall be understood as meaning “including without limitation”;

 

  12.7.6 any reference to any English law term for any action, remedy, method or judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall in respect of any jurisdiction other than England be deemed to include what most nearly approximates in that jurisdiction to the English law term;

 

  12.7.7 where there is any conflict or inconsistency between the main body of this agreement and any of the schedules, then the main body of the agreement shall prevail;

 

  12.7.8 where there is any conflict or inconsistency between the main body of this agreement together with the schedules and any Licence Addendum then the terms of main body of this agreement together with the schedules shall prevail unless expressly stated otherwise in the relevant Licence Addendum;

 

  12.7.9 time shall be of the essence in relation to the performance of the Licensee’s obligations under this Agreement; and

 

  12.7.10 any reference to the sale of a Licensed Product by the Licensee or its Affiliates or Sub-licensees will be taken to include any supply or other disposal of Licensed Products, and the term sold shall be construed accordingly.

 

12.8 Notices. Addresses for Service

 

  12.8.1 Any notice to be given under this Agreement shall be in English, in writing and shall be delivered by first class recorded delivery mail (if sent to an inland address) or by international courier (if sent to an address outside of the United Kingdom), to the address of the relevant Party set out at the head of this Agreement, or such other address as that Party may from time to time notify to the other Party in accordance with this Clause 12.8.

 

  12.8.2 Notices sent as above shall be deemed to have been received one (1) working day after the day of posting in the case of delivery inland first class recorded delivery mail, or three (3) working days after the date of collection by the international courier.

 

12.9 Law and Jurisdiction

The validity, construction and performance of this Agreement, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

12.10 Entire Agreement

This Agreement, including its Schedules, sets out the entire agreement between the Parties relating to its subject matter and supersedes all prior oral or written agreements, arrangements or understandings between them relating to such subject matter. Subject to Clause 10.7.5, the Parties acknowledge that they are not relying on any representation, agreement, term or condition which is not set out in this Agreement.

 

12.11 Third Parties

Except for the rights of UCL as provided in Clause 2.4, the rights of the Indemnitees as provided in Clause 10.6 and the limitations of liability afforded to the Indemnitees pursuant to Clause 10.7, who may in their own right enforce and rely on the provisions of those Clauses, this Agreement does not create any right enforceable by any person who is not a party to it (“Third Party”) under the Contracts (Rights of Third Parties) Act 1999, but this Clause does not affect any right or remedy of a Third Party which exists or is available apart from that Act. The Parties may amend, renew, terminate or otherwise vary all or any of the provisions of this Agreement, including Clauses 2.4, 10.6 and 10.7, without the consent of UCL and/or the Indemnitees.

 

12.12 Non-use of Names; Announcements

 

  12.12.1 The Licensee shall not use, and shall ensure that its Affiliates and Sub-licensees do not use, the name, any adaptation of the name, any logo, trademark or other device of UCLB, nor of the inventors named on the Patents nor the Principal Investigators in any advertising, promotional or sales materials without prior written consent obtained from UCLB in each case, except that the Licensee may state that it is licensed by UCLB under the Patents.

 

  12.12.2 Except as permitted under Clause 6.7, neither Party shall make any press or other public announcement concerning any aspect of this Agreement, or make any use of the name or trade marks of the other Party in connection with or in consequence of this Agreement, without the prior written consent of the other Party.

 

12.13 Escalation

If the Parties are unable to reach agreement on any issue concerning this Agreement or the Project within [***] days after one Party has notified the other of that issue, they will refer the matter to the [***] in the case of UCLB, and to the [***] in the case of the Licensee in an attempt to resolve the issue within the time specified in this Agreement in the case of other disputes. Either Party may bring proceedings in accordance with Clause 12.9 if the matter has not been resolved within that 14 day or such other period as prescribed, and either Party may apply to the court for an injunction, whether or not any issue has been escalated under this clause.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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EXECUTED on the date set out at the head of this Agreement.

 

For and on behalf of

UCL Business PLC

   

For and on behalf of

Athena Vision Ltd

/s/ Anne Lane

   

/s/ Rachel Hemsley

Signed     Signed

Anne Lane

   

Rachel Hemsley

Print name     Print name

Executive Director UCL Business PLC

   

Director

Title     Title

04/02/2015

   

04 February 2015

Date     Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

SCHEDULE 1

TEMPLATE LICENCE ADDENDUM

LICENCE ADDENDUM NUMBER: [    ]

TITLE OF TECHNOLOGY LICENSED: [    ]

DATED: [    ]

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) ATHENA VISION LTD, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”), through the Founders, has developed certain technology and owns certain intellectual property rights relating to the Licensed Technology.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property.

 

C. UCLB and the Licensee entered into an exclusive licence agreement dated 4 February 2015 (the “Licence Agreement”) to govern the terms under which the Licensed Technology will be licensed to the Licensee, subject to the Licensee and UCLB entering into this Licence Addendum in respect of the relevant Licensed Technology.

NOW IT IS AGREED as follows:

 

1. Interpretation

 

1.1 The terms of the Licence Agreement apply to this Licence Addendum.

 

1.2 Defined terms used in the Licence Agreement shall have the same meaning when used herein.

 

1.3 In the case of a conflict between this Licence Addendum and the Licence Agreement, the terms of the Licence Agreement shall prevail unless expressly stated otherwise in this Licence Addendum.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

2. Effective Date

The effective date of this Licence Addendum shall be the same as the Commencement Date of the Licence Agreement (the “Effective Date”).

 

3. Payments

 

3.1 The payments are as specified in Clause 5 of the Licence Agreement.

 

4. Current Development Plan

The Current Development Plan for the Licensed Technology is shown below and shall be subject to Clause 6.3 of the Licence Agreement.

 

Activity

   Timeline
Preclin/manufacture   
Initiate Phase I/II   
Initiate Phase II/III   
BLA submission   

 

5. Law and Jurisdiction.

 

5.1 The validity, construction and performance of this Licence Addendum, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

EXECUTED on the date set out at the head of this Licence Addendum.

 

For and on behalf of

UCL Business PLC

   

For and on behalf of

Athena Vision Ltd

 

Signed

   

 

Signed

 

Print name

   

 

Print name

 

Title

   

 

Title

 

Date

   

 

Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Licence Addendum Number [x]: Appendix 1

Part A – The Licenced Technology

 

The Patents    [insert]
The Know-how   

[Note – Know-how should be described and any key documents listed. For example this may include:

 

•  copies of relevant lab notebooks

 

•  written research reports

 

•  technical dossiers

 

•  databases of test results]

[other]    [insert any other licensed technology info here—e.g. data sets, databases, software etc]
Principal Investigator    [insert]
Field    [insert]
Territory    [insert]

[Part B – Disclosures]

[Appendix 2]

[List of Countries and Territories of the Patents]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

SCHEDULE 2

APPOINTMENT OF EXPERT

If either Party wishes to appoint an independent expert (the “Expert”) to determine any matter pursuant to any Clause of this Agreement, the following procedures will apply:

 

1. The Party wishing to appoint the Expert (“the Appointing Party”) will serve a written notice on the other Party (“the Responding Party”). The written notice will specify the Clause pursuant to which the appointment is to be made and will contain reasonable details of the matter(s) which the Appointing Party wishes to refer to the Expert for determination

 

6. The Parties shall within [***] ([***]) days following the date of the Appointing Party’s written notice use all reasonable efforts to agree who is to be appointed as the Expert to determine the relevant matter(s). If the Parties are unable to agree upon the identity of the Expert within that timescale, the Expert shall be appointed by the President (for the time being) of the Licensing Executives Society Britain and Ireland upon written request of either Party.

 

7. Each Party will within [***] ([***]) days following appointment of the Expert, prepare and submit to the Expert and the other Party a detailed written statement setting out its position on the matter(s) in question and including any proposals which it may wish to make for settlement or resolution of the relevant matter.

 

8. Each Party will have [***] ([***]) days following receipt of the other Party’s written statement to respond in writing thereto. Any such response will be submitted to the other Party and the Expert.

 

9. The Expert will if he/she deems appropriate be entitled to seek clarification from the Parties as to any of the statements or proposals made by either Party in their written statement or responses. Each Party will on request make available all information in its possession and shall give such assistance to the Expert as may be reasonably necessary to permit the Expert to make his/ her determination.

 

10. The Expert will issue his/ her decision on the matter(s) referred to him/ her in writing as soon as reasonably possible, but at latest within [***] ([***]) months following the date of his/ her appointment. The Expert’s decision shall (except in the case of manifest error) be final and binding on the Parties.

 

11. The Expert will at all times act as an independent and impartial expert and not as an arbitrator.

 

12. The Expert’s charges will be borne as he/ she determines in his written decision.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

SCHEDULE 3

DEFINITION OF TOBACCO INDUSTRY FUNDING (REVISED 2009)

FROM THE CANCER RESEARCH UK CODE OF PRACTICE ON TOBACCO INDUSTRY FUNDING TO UNIVERSITIES. http://www.cancerresearchuk.org/science/fundinq/terms-conditions/funding-policies/policy-tobacco/

A tobacco company is defined for the purposes of this policy as one that:

 

    Derives over 5% of revenues from manufacturing tobacco products;

 

    Derives 15%+ of revenues from the manufacture of products necessary for the production of tobacco products;

 

    Derives 15% of revenues from the sale of tobacco products (and has 30 or more staff);

 

    Owns a tobacco company (the company owns 50% or more of a tobacco company);

 

    Is more than 50% owned by a company with tobacco involvement.

The following do not constitute tobacco industry funding for the purposes of this Code:

 

    legacies from tobacco industry investments (provided these are sold on immediately)

 

    funding from a trust or foundation no longer having any connection with the tobacco industry even though it may bear a name that (for historical reasons) has tobacco industry associations.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENCE ADDENDUM NUMBER 1

TITLE OF TECHNOLOGY LICENSED: [***]

DATED: 4 February 2015

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) ATHENA VISION LTD, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”), through the Founders, has developed certain technology and owns certain intellectual property rights relating to the Licensed Technology.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property.

 

C. UCLB and the Licensee entered into an exclusive licence agreement dated 4 February 2015 (the “Licence Agreement”) to govern the terms under which the Licensed Technology will be licensed to the Licensee, subject to the Licensee and UCLB entering into this Licence Addendum in respect of the relevant Licensed Technology.

NOW IT IS AGREED as follows:

 

1. Interpretation

 

1.1 The terms of the Licence Agreement apply to this Licence Addendum.

 

1.2 Defined terms used in the Licence Agreement shall have the same meaning when used herein.

 

1.3 In the case of a conflict between this Licence Addendum and the Licence Agreement, the terms of the Multiple Licence Agreement shall prevail unless expressly stated otherwise in this Licence Addendum.

 

2. Effective Date

The effective date of this Licence Addendum shall be the same as the Commencement Date of the Licence Agreement (the “Effective Date”).

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

3. Payments

The payments are as specified in Clause 5 of the Licence Agreement.

 

4. Current Development Plan

The Current Development Plan for the Licensed Technology is shown below and shall be subject to Clause 6.3 of the Licence Agreement

 

Activity

   Timeline
Preclin/manufacture    [***]
Initiate Phase I/II    [***]
Initiate Phase II/III    [***]
BLA submission    [***]

 

5. Law and Jurisdiction.

The validity, construction and performance of this Licence Addendum, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

EXECUTED on the date set out at the head of this Licence Addendum.

 

For and on behalf of

UCL Business PLC

    

For and on behalf of

Athena Vision Ltd

/s/ Anne Lane

    

/s/ Rachel Hemsley

Signed      Signed

Anne Lane

    

Rachel Hemsley

Print name      Print name

Executive Director UCL Business PLC

    

Director

Title      Title

04/02/2015

    

04 February 2015

Date      Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Licence Addendum Number 1: Appendix 1

Part A – The Licenced Technology

 

The Patents    [***]
The Know-how    [***]
The Know-how Data    [***]
Founders    [***]
Field    As in the Licence Agreement
Territory    As in the Licence Agreement

Part B – Disclosures

[***]

Licence Addendum Number 1: Appendix 2

List of Countries and Territories of the Patents

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENCE ADDENDUM NUMBER 2

TITLE OF TECHNOLOGY LICENSED: [***]

DATED: 4 February 2015

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) ATHENA VISION LTD, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”), through the Founders, has developed certain technology and owns certain intellectual property rights relating to the Licensed Technology.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property,

 

C. UCLB and the Licensee entered into an exclusive licence agreement dated 4 February 2015 (the “Licence Agreement”) to govern the terms under which the Licensed Technology will be licensed to the Licensee, subject to the Licensee and UCLB entering into this Licence Addendum in respect of the relevant Licensed Technology.

NOW IT IS AGREED as follows:

 

1. Interpretation

 

1.1 The terms of the Licence Agreement apply to this Licence Addendum.

 

1.2 Defined terms used in the Licence Agreement shall have the same meaning when used herein.

 

1.3 In the case of a conflict between this Licence Addendum and the Licence Agreement, the terms of the Licence Agreement shall prevail unless expressly stated otherwise in this Licence Addendum.

 

2. Effective Date

The effective date of this Licence Addendum shall be the same as the Commencement Date of the Licence Agreement (the “Effective Date”).

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

3. Payments

The payments are as specified in Clause 5 of the Licence Agreement.

 

4. Current Development Plan

The Current Development Plan for the Licensed Technology is shown below and shall be subject to Clause 6.3 of the Licence Agreement.

 

Activity

   Timeline
Preclin/manufacture    [***]
Initiate Phase I/II    [***]
Initiate Phase II/III    [***]
BLA submission    [***]

 

5. Law and Jurisdiction.

 

5.1 The validity, construction and performance of this Licence Addendum, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

EXECUTED on the date set out at the head of this Licence Addendum.

 

For and on behalf of

UCL Business PLC

   

For and on behalf of

Athena Vision Ltd

/s/ Anne Lane

   

/s/ Rachel Hemsley

Signed     Signed

Anne Lane

   

Rachel Hemsley

Print name     Print name

Executive Director UCL Business PLC

   

Director

Title     Title

04/02/2015

   

04 February 2015

Date     Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Licence Addendum Number 2: Appendix 1

Part A – The Licenced Technology

 

The Patents    [***]
The Know-how    [***]
The Know-how Data    [***]
Founders    [***]
Field    As in the Licence Agreement
Territory    As in the Licence Agreement

Part B – Disclosures

[***]

Licence Addendum Number 2: Appendix 2

List of Countries and Territories of the Patents

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENCE ADDENDUM NUMBER 3

TITLE OF TECHNOLOGY LICENSED: [***]

DATED: 4 February 2015

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) ATHENA VISION LTD, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”), through the Founders, has developed certain technology and owns certain intellectual property rights relating to the Licensed Technology.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property.

 

C. UCLB and the Licensee entered into an exclusive licence agreement dated 4 February 2015 (the “Licence Agreement”) to govern the terms under which the Licensed Technology will be licensed to the Licensee, subject to the Licensee and UCLB entering into this Licence Addendum in respect of the relevant Licensed Technology.

NOW IT IS AGREED as follows:

 

1. Interpretation

 

1.1 The terms of the Licence Agreement apply to this Licence Addendum.

 

1.2 Defined terms used in the Licence Agreement shall have the same meaning when used herein.

 

1.3 In the case of a conflict between this Licence Addendum and the Licence Agreement, the terms of the Licence Agreement shall prevail unless expressly stated otherwise in this Licence Addendum.

 

2. Effective Date

The effective date of this Licence Addendum shall be the same as the Commencement Date of the Licence Agreement (the “Effective Date”).

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

3. Payments

The payments are as specified in Clause 5 of the Licence Agreement.

 

4. Current Development Plan

The Current Development Plan for the Licensed Technology is shown below and shall be subject to Clause 6.3 of the Licence Agreement.

 

Activity

   Timeline
Preclin/manufacture    [***]
Initiate Phase I/II    [***]
Initiate Phase II/III    [***]
BLA submission    [***]

 

5. Law and Jurisdiction

 

5.1 The validity, construction and performance of this Licence Addendum, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

EXECUTED on the date set out at the head of this Licence Addendum.

 

For and on behalf of

UCL Business PLC

   

For and on behalf of

Athena Vision Ltd

/s/ Anne Lane

   

/s/ Rachel Hemsley

Signed     Signed

Anne Lane

   

Rachel Hemsley

Print name     Print name

Executive Director UCL Business PLC

   

Director

Title     Title

04/02/2015

   

04 February 2015

Date     Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Licence Addendum Number 3: Appendix 1

Part A – The Licenced Technology

 

The Patents    [***]
The Know-how    [***]
Founders    [***]
Field    As in the Licence Agreement
Territory    As in the Licence Agreement

Part B – Disclosures

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Licence Addendum Number 3: Appendix 2

List of Countries and Territories of the Patents

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENCE ADDENDUM NUMBER: 5

TITLE OF TECHNOLOGY LICENSED: [***]

DATED: 15 December 2017

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) MEIRAGTX LIMITED (FORMERLY KADMON GENE THERAPY HOLDINGS LIMITED), a company incorporated in England and Wales with registered number 9501998 and having its registered office at c/o Legalinx Ltd, 1 Fetter Lane, London EC4A 1BR (“Meira”).

WHEREAS:

 

A. University College London (“UCL”), through the Founders, has developed certain technology and owns certain intellectual property rights relating to the Licensed Technology.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property.

 

C. UCLB and Athena Vision Ltd (“Athena”) were party to a Licence Agreement dated 4 February 2015, as amended by Amendment No. 1 to Exclusive Licence Agreement, effective as of 27 March 2015, and Amendment No. 2 to Exclusive Licence Agreement effective as of 28 July 2017, by and between UCLB and Athena, and any subsequent amendments, supplements, addendums or modifications thereto or restatements thereof, under which UCLB licensed to Athena certain technology and intellectual property relating to ocular gene therapy, which UCLB acquired by assignment from University College London, for development and commercialization by Athena (the “Licence”).

 

D. Athena and Meira entered into a Collaboration, Development and Licence Agreement dated 27 April 2015 (the “CDLA”) under which Meira and Athena agreed to collaborate on the research, development and commercialisation of the intellectual property licensed to Athena by UCLB under the Licence.

 

E. Subject to the terms and conditions set forth in a Share for Share Exchange Deed between Athena, UCLB, the Founders (as defined therein), [***] and Meira (the “Share Exchange Deed”), the CDLA was terminated in accordance with clause 12.1(a) of the CDLA.

 

F. UCLB, Athena and Meira agreed to novate Athena’s rights, obligations and liabilities under the Licence to Meira on the terms of this Deed of Novation and Amendment with effect from Completion (as defined in the Share Exchange Deed) (the “Effective Date”).

 

G. UCLB now wishes to grant and Meira wishes to accept a licence to the Specified Technology ([***]), subject to UCLB and Meira entering into this Licence Addendum in respect of this Specified Technology. The Parties have agreed that this Specified Technology will be licensed to Meira through this Licence Addendum and under the terms of the Licence as modified herein.

NOW IT IS AGREED as follows:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

1. Interpretation

 

1.1 The terms of the Licence apply to this Licence Addendum.

 

1.2 Defined terms used in the Licence shall have the same meaning when used herein.

 

1.3 In the case of a conflict between this Licence Addendum and the Licence, the terms of the Licence shall prevail unless expressly stated otherwise in this Licence Addendum.

 

2. Effective Date

The effective date of this Licence Addendum shall be the same as the Commencement Date of the Licence (the “Effective Date”).

 

3. Payments

The consideration for this licence is as specified in Clause 5 of the Licence. This Clause 5 covers the developmental milestone, cumulative sales milestone and royalty on Net Sales Value payment for the specified technology [***]. In addition to the payments detailed in Clause 5 of the Licence, Meira shall [***].

 

4. Special Terms

The Parties hereby specifically agree that Clause 5 of this Licence Addendum shall prevail over any conflicting provisions of the Licence.

 

5. Updated Initial Development Plan

The updated Initial Development Plan for the Licensed Technology is shown below and shall be subject to Clause 6.3 of the Licence.

 

Activity

   Timeline
Phase I/II Start    [***]
Phase I/II Finish    [***]
Phase III /pivotal confirmatory study Start    [***]
Phase III /pivotal confirmatory study Finish    [***]

 

6. Law and Jurisdiction.

 

6.1 The validity, construction and performance of this Licence Addendum, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the Parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

EXECUTED on the date set out at the head of this Licence Addendum.

 

For and on behalf of

UCL Business PLC

   

For and on behalf of

MEIRAGTX Limited

/s/ Anne Lane

   

/s/ Richard Giroux

Signed     Signed

Anne Lane

   

Rich Giroux

Print name     Print name

Executive Director

   

Chief Operating Officer

Title     Title

18/12/17

   

12.18.17

Date     Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Licence Addendum Number 5: Schedule 1

Licensed Technology

Part A – The Patents

[***]

Part B – The Know-how

[***]

Part C – The Materials

[***]

Schedule 2

List of Countries and Territories for Patents

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

AMENDMENT NO. 1 TO EXCLUSIVE LICENCE AGREEMENT

THIS AMENDMENT NO. 1 TO EXCLUSIVE LICENCE AGREEMENT (this “Amendment”), effective as of March 27, 2015 (the “Amendment Effective Date”), is entered into by and between Athena Vision Ltd, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”) and UCL Business PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (“UCLB”). The Licensee and UCLB are each sometimes referred to herein as a “Party” and collectively referred to herein as the “Parties”.

W I T N E S S E T H:

WHEREAS, the Parties entered into an Exclusive Licence Agreement dated as of 4th February, 2015 pursuant to which the Licensee is developing and commercializing Licensed Products (the “Agreement”);

WHEREAS, the Parties mutually desire to further amend the Agreement on the terms and conditions set forth in this Amendment.

NOW, THEREFORE, in consideration of the foregoing statements and the mutual agreements and covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

1. Definitions and References. Except as set forth herein, capitalized terms not otherwise defined or amended in this Amendment shall have the meaning ascribed to them in the Agreement, as amended by this Amendment. References to Articles, Sections or Schedules are to the same with all their subparts as they appear in the Agreement. References to Paragraphs are to the numbered paragraphs with all their subparts as they appear in this Amendment.

2. Amendment to the Agreement. Effective as of the Amendment Effective Date, the Agreement shall be amended as set forth in this Paragraph 2:

 

(a) Licence Addendum No. 3 shall be replaced in its entirety by the Licence Addendum No. 3 appended hereto.

3. Warranties.

Each Party hereby warrants to the other Party as follows:

 

  (i) it has the full corporate power and authority to enter into and deliver this Amendment and to perform and consummate the transactions contemplated hereby;

 

  (ii) all corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (iii) this Amendment has been duly executed and delivered by such Party and constitutes a legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other laws affecting creditors’ rights generally or by the availability of equitable remedies; and

 

  (iv) except as expressly amended by this Amendment the Agreement is in full force and effect in accordance with its terms and, to each Party’s knowledge, there exist no breaches, defaults or events which would (with the giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify the Agreement.

4. Other.

 

(a) Effect of Amendment. From and after the Amendment Effective Date, all references to the Agreement shall mean the Agreement as amended by this Amendment.

 

(b) Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Signatures to this Amendment transmitted by fax, by email in “portable document format” (“.pdf”) or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as physical delivery of the paper document bearing original signature.

 

(c) Entire Amendment. This Amendment contains the entire understanding of the Parties with respect to the subject matter of this Amendment. Except as specifically modified and amended hereby, all of the terms, provisions, requirements and specifications contained in the Agreement remain in full force and effect. Except as otherwise expressly provided herein, the Parties do not intend to, and the execution of this Amendment shall not, in any manner impair the Agreement, the purpose of this Amendment being simply to amend certain specific provisions of the Agreement only and to confirm and carry forward the Agreement, as hereby amended, in full force and effect. This Amendment may be amended, or any term hereof modified, only by a written instrument executed by both the Parties.

 

(d) Notices. All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or sent by fax transmission (and promptly confirmed by personal delivery, registered or certified mail or overnight courier) or by registered or certified mail, return receipt requested, postage prepaid, or sent by internationally-recognized overnight courier, in each case to the respective address specified below, or such other address as may be specified in writing to the other party hereto:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

if to The Licensee to:

Athena Vision Limited

c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T

4TP United Kingdom

Attention: Managing Director

Fax No.: +44

if to UCLB to:

UCL Business PLC

The Network Building

97 Tottenham Court Road

London W1T 4TP United Kingdom

Fax No. +44 (0) 20 76679 9838

IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

Athena Vision Limited
By:  

/s/ Stuart Naylor

Name:   Stuart Naylor
Title:   CEO

 

UCL Business PLC
By:  

/s/ Anne Lane

Name:   Anne Lane
Title:   Executive Director

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

LICENCE ADDENDUM NUMBER 3

TITLE OF TECHNOLOGY LICENSED: [***]

DATED: March 27, 2015

BETWEEN:

 

(1) UCL BUSINESS PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) ATHENA VISION LTD, a company incorporated in England and Wales under company registration number 09348737 whose principal place of business is at c/o UCL Business PLC, The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”), through the Founders, has developed certain technology and owns certain intellectual property rights relating to the Licensed Technology.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property.

 

C. UCLB and the Licensee entered into an exclusive licence agreement dated 4th February 2015 (the “Licence Agreement”) to govern the terms under which the Licensed Technology will be licensed to the Licensee, subject to the Licensee and UCLB entering into this Licence Addendum in respect of the relevant Licensed Technology.

NOW IT IS AGREED as follows:

 

1. Interpretation

 

1.1 The terms of the Licence Agreement apply to this Licence Addendum.

 

1.2 Defined terms used in the Licence Agreement shall have the same meaning when used herein.

 

1.3 In the case of a conflict between this Licence Addendum and the Licence Agreement, the terms of the Licence Agreement shall prevail unless expressly stated otherwise in this Licence Addendum.

 

2. Effective Date

The effective date of this Licence Addendum shall be the same as the Commencement Date of the Licence Agreement (the “Effective Date”).

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

3. Payments

The payments are as specified in Clause 4 of the Licence Agreement.

 

4. Current Development Plan

The Current Development Plan for the Licensed Technology is shown below and shall be subject to Clause 6.3 of the Licence Agreement.

 

Activity

   Timeline
Preclin/manufacture    [***]
Initiate Phase I/II    [***]
Initiate Phase II/III    [***]
BLA submission    [***]

 

5. Law and Jurisdiction.

 

5.1 The validity, construction and performance of this Licence Addendum, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Parry may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

EXECUTED on the date set out at the head of this Licence Addendum.

 

For and on behalf of

UCL Business PLC

   

For and on behalf of

Athena Vision Ltd

/s/ Anne Lane

   

/s/ Stuart Naylor

Signed     Signed

Anne Lane

   

Stuart Naylor

Print name     Print name

Executive Director

   

CEO

Title     Title

27/3/15

   

27-3-15

Date     Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

Licence Addendum Number 3: Appendix 1

Part A – The Licenced Technology

 

The Patents    [***]
The Know-how    [***]
[other]    [***]
Founders    [***]
Field    As in the Licence Agreement
Territory    As in the Licence Agreement

[Part B – Disclosures]

Appendix 2

List of Countries and Territories of the Patents

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

AMENDMENT NO. 2 TO EXCLUSIVE LICENCE AGREEMENT

This AMENDMENT NO. 2 TO EXCLUSIVE LICENSE AGREEMENT (this “Amendment”), effective as of July 28, 2017 (the “Amendment Effective Date”), is entered into by and between MeiraGTx Limited, having a place of business located at 92 Britannia Walk, London N1 7NQ United Kingdom (“MeiraGTx”) and UCL Business PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (“UCLB”). MeiraGTx and UCLB are each sometimes referred to herein as a “Party” and collectively referred to herein as the “Parties”.

WITNESSETH:

WHEREAS, UCLB and Athena Vision Ltd., a company incorporated under the laws of England and Wales under company registration number 09348737 (“Athena”) entered into a Licence Agreement dated 4 February 2015, as amended by Amendment No. 1 to Exclusive Licence Agreement, effective as of 27 March 2015 (as amended, the “Licence Agreement”), pursuant to which UCLB licensed to Athena certain technology and intellectual property relating to ocular gene therapy, which UCLB acquired by assignment from University College London, for development and commercialization by Athena.

WHEREAS, pursuant to a Share for Share Exchange Deed made and delivered in 2016 by and among [***] (collectively, the “Transferring Shareholders”), Athena, and MeiraGTx (the “Exchange Deed”), the Transferring Shareholders agreed to sell to MeiraGTx a total of [***] each in the capital of Athena (the “Shares”) in exchange for a certain number of shares of MeiraGTx on the terms and conditions of the Exchange Deed.

WHEREAS, upon the completion of the sale and purchase of the Shares in accordance with Clause 5 of the Exchange Deed occurring on or about April of 2016 (the “Completion”), MeiraGTx increased its shareholding in Athena from 60% to 100% and Athena became a wholly-owned subsidiary of MeiraGTx.

WHEREAS, UCLB, Athena, and MeiraGTx entered into a Deed of Novation and Amendment in 2016 (Deed of Novation and Amendment”) pursuant to which the parties thereto agreed to, among other things, novate Athena’s rights, obligations, and liabilities under the Licence Agreement to MeiraGTx on the terms and conditions of the Deed of Novation and Amendment (the “Novation”).

WHEREAS, the Novation became effective as of the Completion, the Parties now mutually desire to further amend the Licence Agreement on the terms and conditions set forth in this Amendment.

NOW THEREFORE, in consideration of the foregoing statements and the mutual agreements and covenants herein contained, and for other good an valuable consideration, the sufficiency of which are hereby acknowledged, the Parties hereby agree as follows.

1. Definitions. Except as set forth herein, capitalized terms not otherwise defined or amended in this Amendment shall have the meaning ascribed to them in the Licence Agreement, as amended by this Amendment. References to Articles, Clauses, or Schedules are to the same with all their subparts as they appear in the Licence Agreement. References to Sections are to the numbered paragraphs with all their subparts as they appear in this Amendment.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

2. Amendment to the Agreement. Effective as of the Amendment Effective Date, the Agreement shall be and is hereby amended as set forth in this Section 2:

(a)The definition of “First Commercial Sale” is added to Clause 1.1 of the Licence Agreement as follows:

First Commercial Sale means the first sale to a third party of a Licensed Product in a given regulatory jurisdiction after all regulatory and marketing approvals have been obtained for such Licensed Product in such jurisdiction. A sale shall not be deemed to have occurred if a Licensed Product is provided pursuant to an early access or compassionate use;”

(b) The definition of “Licensed Products” as defined in Clause 1.1 of the Licence Agreement is hereby amended and restated as follows:

“Licensed Products means any and all products that are developed, manufactured, used, or sold by or on behalf of the Licensee or its Affiliates or Sub-licensees and which (a) are within (or are manufactured using a process described in) a Valid Claim of the Patents; and/or (b) incorporate, or their development or manufacture makes use of, any of the Know-how and/or the Materials;”

(c) The definition of “Net Receipts” as defined in Clause 1.1 of the Licence Agreement is hereby amended and restated as follows:

Net Receipts means in respect of the Licensed Products, subject to Clause 5.6, the amount of any up-front cash payments (excluding value added or other sales tax), received by the Licensee or its Affiliates, from the Sub-licensee for the sub-licensing (including the grant of any option over a sub-licence) of the Licensed Products, excluding any performance-based milestone (whether at the stage of development, marketing or otherwise), success, bonus, sub-licence maintenance and periodic (including annual) sub-licence payments, due under any sub-licence agreement, and further excluding the following:

a) amounts paid for equity of Licensee, up to its fair market value;

b) debt financing of Licensee by such Sub-licensee;

c) payments or reimbursements for research, development or commercialization services that are undertaken by Licensee for products or services;

d) payments or reimbursements to Licensee for Patent expenses related to products or services;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

e) payments for the supply of products or materials used in performance of services;

f) amounts received by Licensee from a Sub-licensee in consideration for Intellectual Property rights that are not the Patents, Materials or Know-how;

g) payments received in connection with sales of products (including without limitation Licensed Products); or

h) payments on the sale or merger of Licensee.

For the avoidance of doubt, non-cash consideration shall not form Net Receipts until (i) the Licensee has received cash consideration from the use, exploitation, disposal or other realisation of such consideration, or (ii) termination of this Agreement, whichever occurs sooner. Any dividend or similar monetary consideration received in respect of such non-cash consideration shall form Net Receipts.”

(d) The definition of “Net Sales Value” as defined in Clause 1.1 of the Licence Agreement is hereby amended and restated as follows:

Net Sales Value means in respect of the Licensed Products after their First Commercial Sale:

 

  a) the gross amount received by the Licensee or its Affiliates or Sub-licensees in arm’s length sales of Licensed Products for cash consideration; and/ or

 

  b) where the sale is not at arm’s length and/ or is for or includes a non-cash consideration, or if Licensed Products used or subject to Clause 6.10 disposed of for free by the Licensee or its Affiliates the relevant open market price for the Licensed Product in the country or territory in which the sale, use or disposal takes place or if the relevant open market price is not ascertainable, a reasonable price, assessed on an arm’s length basis therefor,

after deduction of all documented:

 

  i) normal trade discounts (including early payment discounts) actually granted and any credits actually given for rejected or returned Licensed Products;

 

  ii) costs of packaging, insurance, carriage and freight, provided in each case that the amounts are separately charged to the purchaser on the relevant invoice;

 

  iii) value added tax or other sales tax; and

 

  iv) import duties or similar applicable government levies charged to the purchaser on the relevant invoice.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Sales of Licensed Products between the Licensee and its Affiliates shall not be taken into account for the purposes of calculating “Net Sales Value” unless there is no subsequent sale to a third party in an arm’s length transaction for a cash consideration;”

(e) Clause 2.2 of the Licence Agreement is hereby amended and restated as follows:

“2.2 UCLB shall at the Licensee’s request and cost execute such formal licences as may be necessary to enable the Licensee to register the licences granted to it under this Agreement with the Patent Offices in the relevant Territory. Such formal licence will reflect the terms of this Agreement where possible and for the avoidance of doubt if there is a conflict in the terms of such formal licence and this Agreement, the terms of this Agreement shall prevail. The Licensee shall use reasonable efforts to ensure that this Agreement shall not form part of any public record, except where disclosure of the terms of this Agreement are required by applicable law, rule or regulation (including the rules or regulations of a stock exchange upon which the Licensee’s shares are sold).”

(f) Clause 5.3 of the Licence Agreement is hereby amended and restated as follows:

 

5.3 Other Milestone Payments Within [***] ([***]) days following achievement of each of the following milestone events by Licensee, its Affiliates or Sub-licensees, the Licensee shall notify UCLB in writing that the relevant milestone event has been achieved, provide documentary evidence of such achievement as appropriate and pay to UCLB, within a period of [***] days, the amount(s) set out next to such milestone event below:

 

Milestone Event

   Amount to be paid

[***]

   £[***]

[***]

   £[***]

(g) Clause 5.4 of the Licence Agreement is hereby amended and restated as follows:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

5.4 Annual Management Fees

On each date referred to in the following table, the Licensee shall pay to UCLB the annual management fee set out next to such date in the table.

 

Date

   Amount to be paid

Upon each anniversary of the Commencement Date until [***]

   £50,000

(h) Clause 5.5 of the Licence Agreement is hereby amended and restated as follows:

 

“5.5 Sales Linked Milestone Payments

Upon achievement of each of the sales linked milestones set out in the following table by the Licensee, its Affiliates or Sub-licensees, the Licensee shall notify UCLB in writing that the relevant sales linked milestone has been achieved, provide the relevant documentary evidence and pay to UCLB the amount(s) set out next to such event in the table:

 

Sales Linked Milestones

   Amount to be paid

When Net Sales Value reaches £[***]

   £[***]

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £[***]

On the next £[***] of Net Sales Value (When sales cumulatively reach £[***])

   £[***]

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £[***]

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £[***]

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £[***]

(i) Clause 5.6 of the Licence Agreement is hereby amended and restated as follows:

 

“5.6 Royalties on Net Sales

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

For each Licensed Product in each country, the Licensee shall pay to UCLB a royalty of [***]% ([***] per cent) being a percentage of the Net Sales Value of all Licensed Products sold by Licensee, its Affiliates or Sub-licensees. The Licensee’s obligations to pay such royalty for a given Licensed Product in a given country shall begin after the First Commercial Sale of such Licensed Product in such country and shall end on the earlier to occur of the following: (a) expiration of the last Valid Claim of a Patent claiming such Licensed Product in such country; or (b) the tenth (10th) anniversary of the date of such First Commercial Sale in such country.”

(j) Clause 5.7 of the Licence Agreement is hereby amended and restated as follows:

 

“5.7 Royalties on Net Receipts

In the event that the Licensee receives an up-front payment from a Sub-licensee, and the up-front payment is also in consideration for Intellectual Property rights that are not the Patents, Materials or Know-how, then the Licensee shall allocate, at a commercially reasonable rate, the portion of the up-front payment that is in consideration for Intellectual Property rights that are the Patents, Materials and Know-how. With respect to such portion, Licensee shall pay to UCLB pay [***] percent ([***]%) of Net Receipts within [***] ([***]) days after Licensee receives such Net Receipts.”

(k) Clauses 5.8 and 5.10 of the Licence Agreement are hereby deleted in their entirety, without effect on the numbering of the other Clauses within Article 5 of the Licence Agreement.

(l) The last paragraph of Clause 5.14 of the Licence Agreement is hereby amended and restated as follows:

“The Licensee shall co-operate with UCLB in good faith to resolve any discrepancies identified     during any such inspection and shall pay any undisputed shortfall in the amounts paid to UCLB under this Agreement, together with interest on late payment as specified in Clause 5.12.4, within [***] days following receipt of a copy of the independent chartered accountant’s report.”

(m) Clause 11.2 of the Licence Agreement is hereby amended and restated as follows:

“Each Licence Addendum and the licences granted in this Agreement, shall come into effect on the Commencement Date and, unless terminated earlier in accordance with this Clause 11 or Clause 12.1.2, the licences granted hereunder shall continue in force on a country by country basis until the later of the last payment obligation of Licensee expires under this Agreement. Upon such expiry, Licensee’s licenses under this Agreement shall become full-paid, perpetual and irrevocable.”

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

3. Warranties. Each Party hereby warrants to the other Party as follows:

(a) it has the full corporate power and authority to enter into and deliver this Amendment and to perform and consummate the transactions contemplated hereby;

(b) all corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;

(c) this Amendment has been duly executed and delivered by such Party and constitutes a legal, valid, and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other laws affecting creditor’s rights generally or by the availability of equitable remedies; and

(d) except as expressly amended by this Amendment, the Agreement is in full force and effect in accordance with its terms and, to each Party’s knowledge, there exists no breaches, defaults or events which would (with the giving of notice, the passage of time or both) give rise to a breach, default, or other right to terminate or modify the Agreement.

4. Other.

(a) Effect of Amendment. From and after the Amendment Effective Date, all references to the Agreement shall mean the Agreement as amended by this Amendment.

(b) Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Signatures to this Amendment transmitted by fax, by email in “portable document format” (“.pdf”) or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as physical delivery of the paper document bearing original signature.

(c) Entire Amendment. This Amendment contains the entire understanding of the Parties with respect to the subject matter of this Amendment. Except as specifically modified and amended hereby, all of the terms, provisions, requirements and specifications contained in the Agreement remain in full force and effect. Except as otherwise expressly provided herein, the Parties do not intend to, and the execution of this Amendment shall not, in any manner, impair the Agreement, the purpose of this Amendment being simply to amend certain specific provisions of the Agreement only and to confirm and carry forward the Agreement, as hereby amended, in full force and effect. This Amendment may be amended, or any term hereof modified, only by a written instrument executed by both the Parties.

(d) Notices. All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or sent by fax transmission (and promptly confirmed by personal delivery, registered or certified mail or overnight courier) or by registered or certified mail, return receipt requested, postage prepaid, or sent by internationally-recognized overnight courier, in each case to the respective address specified below, or such other address as may be specified in writing to the other party hereto:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

If to MeiraGTx to:

 

MeiraGTx Limited

92 Britannia Walk,

London N1 7NQ United Kingdom

Fax No.: [•]

Attention: [•]

If to UCLB to:

 

UCL Business PLC

The Network Building

97 Tottenham Court Road

London W1T 4TP United Kingdom

Fax No.: +44 (0) 20 76679 9838

Attention: [•]

[Signature Page Follows]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

MEIRAGTX LIMITED
By:  

/s/ Richard Giroux

Name:   Richard Giroux
Title:   Chief Operating Officer
UCL BUSINESS PLC
By:  

/s/ Anne Lane

Name:   Anne Lane
Title:   Executive Director

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

AMENDMENT NO. 3 TO EXCLUSIVE LICENCE AGREEMENT

This AMENDMENT NO. 3 TO EXCLUSIVE LICENSE AGREEMENT (this “Amendment”), effective as of December 14, 2017 (the “Amendment Effective Date”), is entered into by and between MeiraGTx Limited, having a place of business located at 92 Britannia Walk, London N1 7NQ United Kingdom (“MeiraGTx”) and UCL Business PLC, whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (“UCLB”). MeiraGTx and UCLB are each sometimes referred to herein as a “Party” and collectively referred to herein as the “Parties”.

WITNESSETH:

WHEREAS, UCLB and Athena Vision Ltd., a company incorporated under the laws of England and Wales under company registration number 09348737 (“Athena”) entered into a Licence Agreement dated 4 February 2015, as amended by Amendment No. 1 to Exclusive Licence Agreement, effective as of 27 March 2015 and Amendment No. 2, effective as of July 28, 2017 (as amended, the “Licence Agreement”), pursuant to which UCLB licensed to Athena certain technology and intellectual property relating to ocular gene therapy, which UCLB acquired by assignment from University College London, for development and commercialization by Athena.

WHEREAS, pursuant to a Share for Share Exchange Deed made and delivered in 2016 by and among [***] (collectively, the “Transferring Shareholders”), Athena, and MeiraGTx (the “Exchange Deed”), the Transferring Shareholders agreed to sell to MeiraGTx a total of [***] in the capital of Athena (the “Shares”) in exchange for a certain number of shares of MeiraGTx on the terms and conditions of the Exchange Deed.

WHEREAS, upon the completion of the sale and purchase of the Shares in accordance with Clause 5 of the Exchange Deed occurring on or about April of 2016 (the “Completion”), MeiraGTx increased its shareholding in Athena from 60% to 100% and Athena became a wholly-owned subsidiary of MeiraGTx.

WHEREAS, UCLB, Athena, and MeiraGTx entered into a Deed of Novation and Amendment in 2016 (Deed of Novation and Amendment”) pursuant to which the parties thereto agreed to, among other things, novate Athena’s rights, obligations, and liabilities under the Licence Agreement to MeiraGTx on the terms and conditions of the Deed of Novation and Amendment (the “Novation”).

WHEREAS, the Novation became effective as of the Completion, the Parties now mutually desire to further amend the Licence Agreement on the terms and conditions set forth in this Amendment.

NOW THEREFORE, in consideration of the foregoing statements and the mutual agreements and covenants herein contained, and for other good an valuable consideration, the sufficiency of which are hereby acknowledged, the Parties hereby agree as follows.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

1. Definitions. Except as set forth herein, capitalized terms not otherwise defined or amended in this Amendment shall have the meaning ascribed to them in the Licence Agreement, as amended by this Amendment. References to Articles, Clauses, or Schedules are to the same with all their subparts as they appear in the Licence Agreement. References to Sections are to the numbered paragraphs with all their subparts as they appear in this Amendment.

2. Amendment to the Agreement. Effective as of the Amendment Effective Date, the Agreement shall be and is hereby amended as set forth in this Section 2:

(a) The definition of “Licensed Technology” as defined in Clause 1.1 of the Licence Agreement is hereby amended and restated as follows:

“Licensed Technology means Intellectual Property, Patents and Know-how relating to each technology licensed by UCLB to the Licensee under any License Addendum to this Agreement,”

3. Warranties. Each Party hereby warrants to the other Party as follows:

(a) it has the full corporate power and authority to enter into and deliver this Amendment and to perform and consummate the transactions contemplated hereby;

(b) all corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;

(c) this Amendment has been duly executed and delivered by such Party and constitutes a legal, valid, and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other laws affecting creditor’s rights generally or by the availability of equitable remedies; and

(d) except as expressly amended by this Amendment, the Agreement is in full force and effect in accordance with its terms and, to each Party’s knowledge, there exists no breaches, defaults or events which would (with the giving of notice, the passage of time or both) give rise to a breach, default, or other right to terminate or modify the Agreement.

4. Other.

(a) Effect of Amendment. From and after the Amendment Effective Date, all references to the Agreement shall mean the Agreement as amended by this Amendment.

(b) Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Signatures to this Amendment transmitted by fax, by email in “portable document format” (“.pdf”) or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as physical delivery of the paper document bearing original signature.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

(c) Entire Amendment. This Amendment contains the entire understanding of the Parties with respect to the subject matter of this Amendment. Except as specifically modified and amended hereby, all of the terms, provisions, requirements and specifications contained in the Agreement remain in full force and effect. Except as otherwise expressly provided herein, the Parties do not intend to, and the execution of this Amendment shall not, in any manner, impair the Agreement, the purpose of this Amendment being simply to amend certain specific provisions of the Agreement only and to confirm and carry forward the Agreement, as hereby amended, in full force and effect. This Amendment may be amended, or any term hereof modified, only by a written instrument executed by both the Parties.

(d) Notices. All notices, requests and other communications hereunder shall be in writing and shall be personally delivered or sent by fax transmission (and promptly confirmed by personal delivery, registered or certified mail or overnight courier) or by registered or certified mail, return receipt requested, postage prepaid, or sent by internationally-recognized overnight courier, in each case to the respective address specified below, or such other address as may be specified in writing to the other party hereto:

If to MeiraGTx to:

MeiraGTx Limited

92 Britannia Walk,

London N1 7NQ United Kingdom

Fax No.: [•]

Attention: [•]

If to UCLB to:

UCL Business PLC

The Network Building

97 Tottenham Court Road

London W1T 4TP United Kingdom

Fax No.: +44 (0) 20 76679 9838

Attention: [•]

[Signature Page Follows]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 


Confidential Treatment Requested by MeiraGTx Holdings plc

 

IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

MEIRAGTX LIMITED
By:  

/s/ Richard Giroux

Name:   Richard Giroux
Title:   Chief Operating Officer
UCL BUSINESS PLC
By:  

/s/ Anne Lane

Name:   Anne Lane
Title:   Executive Director

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

EX-10.12

Exhibit 10.12

Confidential Treatment Requested by MeiraGTx Holdings plc

LICENCE AGREEMENT

between

UCL Business Plc

and

MeiraGTx UK II Limited

Dated: 28th July 2017

Ref:

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

INDEX

 

1.

   Definitions      1  

2.

   Grant of Rights      5  

3.

   Know-how and Confidential Information      10  

4.

   Response to NIH      13  

5.

   Consideration      13  

6.

   Commercialisation      17  

7.

   Access to Medicines and Ethical Licensing      20  

8.

   Compliance with Laws      21  

9.

   Intellectual Property      22  

10.

   Warranties and Liability      25  

11.

   Insurance: MEEI Requirements      29  

12.

   Duration and Termination      30  

13.

   General      33  

Schedule 1 Licensed Technology

     38  

Schedule 2 Appointment of Expert

     39  

Schedule 3 Definition of Tobacco Industry Funding (Revised 2009)

     41  

Schedule 4 List of Countries and Territories for Patents

     42  

Schedule 5 Initial Development Plan

     43  

 

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

i


Confidential Treatment Requested by MeiraGTx Holdings plc

 

THIS AGREEMENT is made                                             July 28, 2017

BETWEEN:

 

(1) UCL BUSINESS PLC, a company incorporated in England and Wales under company registration number 02776963 whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

 

  and

 

(2) MEIRAGTX UK II LIMITED, (FORMERLY KADMON GENE THERAPY HOLDINGS LIMITED), a company incorporated in England and Wales with registered number 09348737 and having its registered office at 92 Britannia Walk, London, United Kingdom, N1 7NQ (the “Licensee”).

WHEREAS:

 

A. University College London (“UCL”) , the Medical Research Council (“MRC”), Massachusetts Eye and Ear Infirmary (“MEEI”), and National Institutes of Health which is a part of the U.S. Department of Health and Human Services (“NIH”) developed certain technology and owned certain intellectual property rights relating to a gene therapy for treating retinitis pigmentosa using an abbreviated form of a human Retinitis Pigmentosa GTPase Regulator (RPGR) gene.

 

B. The MRC has entered into an assignment agreement with UCLB in which it assigned all of its right, title and interest in and to the Patent Rights as defined in that assignment to UCLB.

 

C. UCL and [***], an employee of UCL, have entered into an assignment agreement with UCLB in which UCL and [***] assigned all of their right, title and interest in and to the Assigned Property as defined in that assignment to UCLB.

 

D. The NIH has licensed, maintaining certain reserved rights, all of its right, title and interest in and to the Patents, the Know-how and the Materials to MEEI. MEEI has granted to UCLB, maintaining certain reserved rights, an exclusive licence under the Patents and to use the Know-how and Materials.

 

E. The Licensee wishes to acquire rights under the Patents and to use the Know-how and the Materials for the development and commercialisation of Licensed Products in the Field and in the Territory, all in accordance with the provisions of this Agreement.

 

F. MeiraGTx UK II Ltd. aims to develop and commercialize the Licensed Product in the Field and in the Territory.

 

G. It is the policy of UCLB that its activities in licensing intellectual property take into consideration ethical and socially responsible licensing principles, including ensuring that Licensed Products are made available to fulfil unmet needs in Developing Countries, and the Licensee acknowledges and agrees to carry out its activities under this Agreement in a manner which complies with ethical and socially responsible licensing principles and which is designed to fulfil such needs, all in accordance with the provisions of this Agreement.

NOW IT IS AGREED as follows:

 

1. DEFINITIONS

 

1.1 In this Agreement:

Agreement means this agreement (including the Schedules);

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

1


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Affiliate in relation to a Party, means any entity or person that Controls, is Controlled by, or is under common Control with that Party;

At-Cost Markets means those markets in Developing Countries [***];

Claims means all demands, claims and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, costs and expenses of any nature whatsoever and all costs and expenses (including legal costs) incurred in connection therewith;

Commencement Date means the date of last signature of this Agreement;

Commercial Third Party means a commercial entity that is not a Party of this Agreement;

Competing Product means any product, whether ready for marketing or in development that competes, or is likely to compete once developed, with any Licensed Product;

Confidential Information means the Know-how, the Materials and all other technical or commercial information that:

 

  a) in respect of information provided in documentary form or by way of a model or in other tangible form, at the time of provision is marked or otherwise designated to show expressly that it is imparted in confidence or which a reasonable person would expect to be confidential; and

 

  b) in respect of information that is imparted orally, any information that the Disclosing Party or its representatives informed the Receiving Party at the time of disclosure or which a reasonable person would expect to be confidential;

Control means direct or indirect beneficial ownership of 50% (or, outside a Party’s home territory, such lesser percentage as is the maximum permitted level of foreign investment) or more of the share capital, stock or other participating interest carrying the right to vote or to distribution of profits of that Party, as the case may be;

Cost-Based Price means, in respect of each Licensed Product, [***];

Developing Country or Developing Countries refers to those countries that are:

 

  a) [***]; and

 

  b) to the extent not included in a);

 

  i) defined as of the Commencement Date [***]; and

 

  ii) all other countries that may be mutually agreed to by UCL and Licensee from time to time;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

Developing Country Manufacturer means a manufacturer of pharmaceutical products that is able to efficiently manufacture (either within or outside the Developing Country in which the At-Cost market exists), distribute and supply the Licensed Product in an At-Cost market at a Cost-Based Price;

Diligent Efforts means exerting such efforts and employing such resources as would normally be exerted or employed by [***], when utilizing sound and reasonable scientific, medical and business practice and judgment in order to develop the product in a timely manner and generate an economic return to the Parties from its commercialisation;

Disclosing Party has the meaning given in Clause 3.3;

Field means ocular gene therapy;

First Commercial Sale means the first sale to a third party of a Licensed Product in a given regulatory jurisdiction after all regulatory and marketing approvals have been obtained for such Licensed Product in such jurisdiction. A sale shall not be deemed to have occurred if a Licensed Product is provided pursuant to an early access or compassionate use

Indemnitees has the meaning given in Clause 10.6;

Intellectual Property means any and all patents, utility models, registered designs, unregistered design rights, copyright, database rights, rights in respect of confidential information, rights under data exclusivity laws, rights under orphan drug laws, rights under unfair competition laws, property rights in biological or chemical materials, extension of the terms of any such rights (including supplementary protection certificates), applications for and the right to apply any of the foregoing registered property and rights, and similar or analogous rights in any part of the Territory;

Know-how means:

 

  a) the inventions claimed in the Patents; and

 

  b) the technical information relating to the inventions claimed in the Patents and data described in the Part B of Schedule 1

Licensed Products means any and all products that are developed, manufactured, used, or sold by or on behalf of the Licensee or its Affiliates or Sub-licensees and which (a) are within (or are manufactured using a process described in) the Patents; and/or (b) incorporate, or their development or manufacture makes use of, any of the Know-how and/or the Materials.

Materials means any and all of the materials referred to in Part C of Schedule 1.

MEEI Indemnitees has the meaning given in Clause 10.7.1.

Net Sales Value means in respect of the Licensed Products after their First Commercial Sale:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

3


Confidential Treatment Requested by MeiraGTx Holdings plc

 

  a) the gross invoiced price of Licensed Products sold by the Licensee or its Affiliates or Sub-licensees in arm’s length sales of Licensed Products for cash consideration; and/ or

 

  b) where the sale is not at arm’s length and/ or is for or includes a non-cash consideration, or if Licensed Products used or subject to Clause 6.9, disposed of for free by the Licensee or its Affiliates the relevant open market price for the Licensed Product in the country or territory in which the sale, use or disposal takes place or if the relevant open market price is not ascertainable, a reasonable price, assessed on an arm’s length basis therefor,

 

  after deduction of all documented:

 

  i) normal trade discounts (but excluding early payment discounts) actually granted and any credits actually given for rejected or returned Licensed Products;

 

  ii) costs of packaging, insurance, carriage and freight, provided in each case that the amounts are separately charged to the purchaser on the relevant invoice;

 

  iii) deductions for actual bad debt in connection with sales of Licensed Product (provided that Licensee will use Diligent Efforts to obtain payment of such bad debt);

 

  iv) value added tax or other sales tax; and

 

  v) import duties or similar applicable government levies charged to the purchaser on the relevant invoice.

provided that such deductions do not exceed reasonable and customary amounts in the markets in which such sales occurred. Sales of Licensed Products between the Licensee and its Affiliates shall not be taken into account for the purposes of calculating “Net Sales Value” unless there is no subsequent sale to a third party in an arm’s length transaction for a cash consideration;

Parties means UCLB and the Licensee, and “Party” shall mean either of them;

Patents means any and all of the patents and patent applications referred to in Part A of Schedule 1, including any continuations, continuations in part, extensions, reissues, divisions, and any patents, supplementary protection certificates and similar rights that are based on or derive priority from the foregoing.

Principal Investigators means [***].

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

4


Confidential Treatment Requested by MeiraGTx Holdings plc

 

Reasonable Developing Country Licence Terms means terms that meet the requirements of both UCL’s ethical and socially responsible licensing policy, which is at: (http://www.ucl.ac.uk/enterprise/about/policies/files/Global_access-final.pdf) and the following principles:

 

  a) the Licensee shall [***];

 

  b) the Developing Country licence terms [***] that shall not [***];

 

  c) if the Developing Country Manufacturer is granted any exclusive rights, the continued grant of those rights shall be conditional upon the Developing Country Manufacturer supplying At-Cost Markets at a Cost-Based Price and meeting market demand in that market; and

 

  d) the Licensee may impose reasonable conditions, including as to use of trade marks, trade dress, format and pack size, to differentiate the Licensed Product when sold in the At-Cost market from Licensed Products sold in other markets and to prohibit their export into other markets and territories, provided that such conditions or their implementation do not act as an unreasonable barrier to the prompt and efficient supply of Licensed Product in the At-Cost market;

Receiving Party means has the meaning given in Clause 3.3;

Regulatory Exclusivity means, with respect to a Licensed Product, any exclusive rights or protection which are recognised, afforded or granted by any Regulatory Authority in any country or region with respect to the Licensed Product other than through patent rights;

Sub-licensee means any third party (other than an Affiliate) to whom the Licensee grants a sub-licence of its rights under this Agreement in accordance with Clause 2.3;

Territory means Worldwide;

Valid Claim means a claim of a patent or patent application that has not been abandoned or allowed to lapse or expired or been held invalid or unenforceable by a court of competent jurisdiction in a final and non-appealable judgment.

 

2. GRANT OF RIGHTS

 

2.1 Licence

UCLB hereby grants to the Licensee and its Affiliates, and the Licensee hereby accepts on its own behalf and on behalf of its Affiliates, subject to the provisions of this Agreement:

 

  2.1.1 an exclusive (even as to UCL) licence under the Patents, with the right to sub-license, subject to Clause 2.3, to develop, commercialise, manufacture, have manufactured, use, sell and have sold Licensed Products only in the Field and in the Territory; and

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

5


Confidential Treatment Requested by MeiraGTx Holdings plc

 

  2.1.2 an exclusive (even as to UCL) licence to use the Know-how and the Materials, with the right to sub-license, subject to Clause 2.3, to develop, commercialise, manufacture, have manufactured, use, sell and have sold Licensed Products only in the Field and in the Territory.

 

2.2 UCLB shall at the Licensee’s request and cost execute such formal licences as may be necessary to enable the Licensee to register the licences granted to it under this Agreement with the Patent Offices in the relevant Territory. Such formal licence will reflect the terms of this Agreement where possible and for the avoidance of doubt if there is a conflict in the terms of such formal licence and this Agreement, the terms of this Agreement shall prevail. The Licensee shall ensure that this Agreement shall not form part of any public record, except where disclosure of the terms of this Agreement are required by applicable law, rule or regulation (including the rules or regulations of a stock exchange upon which the Licensee’s shares are sold).

 

2.3 Sub-Licensing

The Licensee shall have the right to grant sub-licences under the licence in Clause 2.1 to its Affiliates or other third parties through one or more levels of Sub-licensees except that the Licensee may not grant such a sub-licence to any person or the Affiliates of any person involved in: the tobacco industry (as defined by the Cancer Research UK Code of Practice on Tobacco Industry Funding to Universities detailed in Schedule 3); arms dealing; gambling operations; the promotion of violence; child labour or any other illegal activity. A grant of any sub-licence shall be conditional on the following:

 

  (a) The Licensee shall enter into a written agreement with each Sub-licensee and shall ensure that the provisions of each sub-licence are consistent with the provisions of this Agreement, and the Licensee shall ensure that:

 

  (i) the sub-licence sets out all the proposed terms agreed between the Licensee and the Sub-licensee, including, in particular, all terms as to remuneration;

 

  (ii) the Sub-licensee will maintain complete and accurate records in sufficient detail to permit UCLB to confirm the accuracy of the calculation of royalty payments under this Agreement; and

 

  (iii) the sub-licence imposes obligations of confidentiality on the Sub-licensee which are no less onerous than those set out in Clause 3.3.

 

  (b) The Licensee shall procure that each Sub-licensee complies fully at all times with the provisions of its sub-licence.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  (c) The Licensee shall be liable for all acts and omissions of its Sub-licensees that, if committed by the Licensee, would constitute a breach of any of the provisions of this Agreement.

 

  (d) The Licensee shall provide UCLB with a copy of any sub-licence [***] ([***]) days after execution of such sub-licence, provided that the Licensee may redact confidential or proprietary terms from such copy, including financial terms.

 

  (e) Each sub-licence shall terminate automatically upon termination of this Agreement for any reason (but not expiry of this Agreement under Clause 12.1) except where:

 

  (i) the Sub-licensee was not implicated in or at fault in any circumstances which led to the termination of this Agreement;

 

  (ii) the benefit (but not the burden) of the sub-licence agreement is validly assigned to UCLB in writing within [***] ([***]) days following the date of termination of this Agreement; and

 

  (iii) following assignment, the Sub-licensee observes in full the terms of the sub-licence agreement including paying all sums due to the Licensee under the sub-licence agreement directly to UCLB in a timely manner, in which case the Sub-licensee’s rights to use the Patents, the Know-How and/or the Materials shall continue in full force and effect in accordance with the terms of the relevant sub-licence agreement.

 

2.4 Reservation of Rights

UCLB reserves for itself and UCL the non-exclusive, irrevocable, worldwide, royalty-free right to:

 

  (a) Use the Patents, the Know-how and the Materials in the Field solely for academic research, publication and teaching; and

 

  (b) Grant licences to academic third parties to use the Patents, the Know-how and the Materials solely in academic research collaborations with UCL; and

 

  (c) Grant licences of the Patents, the Know-how and the Materials to post graduate students of UCL solely for the purpose of conducting a programme of post graduate academic research.

In exercising the rights described in Clause 2.4.1 (b) and (c), UCL and UCLB shall comply with the provisions of Clause 3 as regards confidentiality of the Know-how.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  2.4.2 UCLB reserves for MEEI the non-exclusive, irrevocable, worldwide, royalty-free right to:

 

  (a) use the Patents, the Know-how and the Materials solely for MEEI’s own internal non-commercially funded research, publication and teaching, excluding use in human subjects, clinical trials or for diagnostic purposes involving human subjects;

 

  (b) to license other academic institutions to use the Patents, the Know-how and the Materials solely in non-commercially funded academic research collaborations with MEEI, excluding research for use in human subjects, clinical trials or research for diagnostic purposes involving human subjects; and

 

  (c) to grant licences of the Patents, the Know-how and the Materials to other academic, governmental or not-for-profit organisations to use the Patents, the Know-how and the Materials solely for non-commercial research purposes and not for use in human subjects, clinical trials or for diagnostic purposes involving human subjects.

 

  2.4.3 MEEI and UCLB will refer a request from a third party for a licence to use the Patents in clinical trials or for diagnostic purposes involving human subjects to the Licensee, and the Licensee shall liaise directly with such third party.

 

  2.4.4 UCLB reserves for the U.S. Government only the irrevocable, royalty-free, paid-up right to practice and have practiced the rights under the Patents throughout the world by or on behalf of the U.S. Government and on behalf of any foreign government or international organisation pursuant to any existing or future treaty or agreement to which the U.S. Government is a signatory.

 

  2.4.5 UCLB reserves the right, if required by the NIH, to grant sub-licenses of the rights under the Patents to responsible applicants, on terms that are reasonable under the circumstances when necessary to fulfill health or safety needs or when necessary to meet requirements for public use specified by U.S. Federal regulations.

 

  2.4.6 UCLB reserves for the NIH only the right to require the Licensee, to grant sub-licenses of the rights under the Patents to responsible applicants, on terms that are reasonable under the circumstances when necessary to fulfill health or safety needs or when necessary to meet requirements for public use specified by U.S. Federal regulations.

 

  2.4.7

In addition to the reserved rights of Clause 2.4.5, UCLB reserves the right, should it be required by the NIH, to grant a non-transferable, non-exclusive license to make and to use any tangible embodiment of the Patents and to practice any process(es)

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  included within the Patents for purposes of internal research and not for purposes of commercial manufacture or distribution or in lieu of purchase, on reasonable terms and conditions.

 

  2.4.8 In addition to the reserved rights of Clause 2.4.6, UCLB reserves for the NIH only the right to require the Licensee to grant a non-transferable, non-exclusive license to make and to use any tangible embodiment of the Patents and to practice any process(es) included within the Patents for purposes of internal research and not for purposes of commercial manufacture or distribution or in lieu of purchase, on reasonable terms and conditions.

 

  2.4.9 UCLB reserves for the MRC the non-exclusive right to:

 

  (a) use the Patents for its own internal, not-for-profit and non-commercially funded research, teaching and publicity, excluding use in human subjects, clinical trials or for diagnostic purposes involving human subjects; and

 

  (b) licence academic institutions who employ Professor Alan Wright and Dr Xinhua Shu to use the Patents in not-for-profit and non-commercially funded research, excluding research for use in human subjects, clinical trials or research for diagnostic purposes involving human subjects.

 

  2.4.10 Except for the licences expressly granted by this Clause 2, UCLB grants no rights to the Licensee under this Agreement to or under any intellectual property other than the Patents, the Know-how and the Materials and hereby reserves all rights under the Patents, the Know-how and the Materials outside the Field.

 

  2.4.11 Nothing in this Agreement shall limit or otherwise affect UCL’s ability to apply for non-commercial grant funding or comply with such grant terms and conditions. In the event that any terms of this Agreement conflicts with the terms of any non-commercial grant funding, the Parties shall negotiate in good faith to amend the terms of this Agreement to allow UCL to access such funding provided that nothing herein shall require the Licensee to agree to alter or modify the scope of the licence granted to it in this Clause 2.

 

2.5 Affiliates

The Licensee shall:

 

  2.5.1 ensure that its Affiliates comply fully with the terms of this Agreement;

 

  2.5.2 be responsible for any breach of or non-compliance with this Agreement by its Affiliates as if the breach or non-compliance had been a breach or non-compliance by the Licensee;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  2.5.3 indemnify in accordance with Clause 10.6 each of the Indemnitees against any Claims which are awarded against or suffered by any of the Indemnitees as a result of any breach of or non-compliance with this Agreement by its Affiliates; and

 

  2.5.4 ensure that if any Affiliate ceases to be an Affiliate as a result of a change of Control or otherwise, that unless a sub-licence agreement in accordance with Clause 2.3 is entered into with such an Affiliate, such former Affiliate immediately upon such cessation:

 

  (a) ceases developing, manufacturing, having manufactured, using, selling and/ or having sold Licensed Products and ceases all use or exploitation of the Licensed Technologies, for as long as any of the relevant Patents remains in force and/or the Know-how remains confidential;

 

  (b) returns to the Licensee or destroys any documents or other materials in the former Affiliate’s possession or under its control and that contain Confidential Information provided under this Agreement relating to the Licensed Technologies and/ or Licensed Products;

 

  (c) to the extent possible, takes all action necessary to have any product licences, marketing authorisations, pricing and/ or reimbursement approvals (and any applications for any of the foregoing) which relate to Licensed Products transferred into the name of the Licensee.

 

3. KNOW-HOW AND CONFIDENTIAL INFORMATION

 

3.1 Provision of Know-how

Within [***] ([***]) days following the Commencement Date, UCLB shall deliver to the Licensee the Materials and a copy of the Know-how.

 

3.2 Confidentiality of Know-how and Materials

The Licensee undertakes that for so long as the Know-how and / or the Materials remains confidential, it shall (and shall ensure that its Affiliates and Sub-licensees) take all reasonable precautions to prevent unauthorised access to the Know-how and the Materials and protect the Know-how and the Materials in the same manner as it (or they) protect(s) its (or their) own proprietary information, and shall not (and shall ensure that its Affiliates and Sub-licensees do not) use the Know-how or the Materials for any purpose, except as expressly licensed hereby and in accordance with the provisions of this Agreement. For the avoidance of doubt, to the extent that any Materials, Know-how or information relating to the Patents falls within the public domain (without any breach of this Agreement or any other obligation of confidentiality), then UCL, the Founders and UCLB shall be free to use such information without restriction in the same way that any third party would have the freedom to use it.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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3.3 Confidentiality Obligations

Each Party (“Receiving Party”) undertakes:

 

  3.3.1 to maintain as secret and confidential all Confidential Information obtained from the other Party (“Disclosing Party”) in the course of or in anticipation of this Agreement and to respect the Disclosing Party’s rights therein;

 

  3.3.2 to use such Confidential Information only for the purposes of or as permitted by this Agreement; and

 

  3.3.3 subject to Clause 3.4, to disclose such Confidential Information only to those of its employees, contractors, Affiliates, and Sub-licensees (if any) to whom and to the extent that such disclosure is reasonably necessary for the purposes of this Agreement.

 

3.4 Permitted Disclosure

 

  3.4.1 UCLB shall have the right to provide the MRC and MEEI with brief annual updates on the status of the commercial exploitation of the Patents, the Materials and the Know-how.

 

  3.4.2 UCLB shall have the right to disclose to the MRC under binding obligations of confidentiality:

 

  (a) that it has entered into this Agreement with the Licensee;

 

  (b) details of all milestone payments and royalty payments provided for in this Agreement;

 

  (c) a copy of the Initial Development Plan;

 

  (d) details of any development milestones provided for in this Agreement

 

  3.4.3 the Licensee shall have the right to disclose Confidential Information received from UCLB to:

 

  (a) potential or actual customers of Licensed Products to the extent reasonably necessary to promote the sale or use of Licensed Products and provided that the customer has agreed to confidentiality provisions at least as restrictive as set forth herein;

 

  (b) to existing or potential Sub-licensees, collaborators, investors or lenders provided that such third parties have agreed to confidentiality provisions at least as restrictive as set forth herein; and

 

  (c) to its Board of Directors (or similar governing body) and its counsel, accountants and other professional advisers.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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3.5 Exceptions to Obligations

The provisions of Clause 3.3 shall not apply to Confidential Information which the Receiving Party can demonstrate by reasonable written evidence:

 

  3.5.1 was, prior to the Commencement Date, in the possession of the Receiving Party and at its free disposal and was not obtained or otherwise acquired directly or indirectly from the Disclosing Party or its Affiliates or their respective employees, students or representatives; or

 

  3.5.2 is subsequently disclosed to the Receiving Party without any obligations of confidence by a third party; or

 

  3.5.3 is or becomes generally available to the public through no act or default of the Receiving Party or its agents, employees, Affiliates or Sub-licensees; or

 

  3.5.4 the Receiving Party is required to disclose by or to the courts of any competent jurisdiction, or to any government regulatory agency or financial authority, provided that the Receiving Party shall:

 

  (a) inform the Disclosing Party as soon as is reasonably practicable;

 

  (b) at the Disclosing Party’s request and cost seek to persuade the court, agency or authority to have the information treated in a confidential manner, where this is possible under the court, agency or authority’s procedures; and

 

  (c) where the disclosure is unavoidable, limit the disclosure of Confidential information to the minimum extent required by law; or

 

  3.5.5 which a Party is advised by its information officer that it is required to disclose under the Freedom of Information Act 2000 or the Environmental Information Regulations 2004.

 

3.6 Disclosure to Employees

The Receiving Party shall procure that all of its employees, contractors, Affiliates and Sub-licensees who have access to any of the Disclosing Party’s Confidential Information to which Clause 3.3 applies, shall be made aware of the obligations of confidence and enter into written undertakings of confidentiality at least as restrictive as those set forth herein (which it undertakes to enforce and for which it is legally responsible) and the Receiving Party shall only disclose the Disclosing Party’s Confidential Information to those of its subsidiaries, employees, and officers as need to have access thereto wholly necessarily and exclusively for the purposes of this Agreement.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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4. RESPONSE TO NIH

If the Licensee is notified of a determination of a conflict of interest regarding the Patents by the NIH it shall provide a response to such determination to the NIH within the period given by NIH to respond to such determination.

 

5. CONSIDERATION

 

5.1 Initial Payment

On or before the Commencement Date, the Licensee shall pay to UCLB a non-refundable, non-deductible payment of $17,888.00 (seventeen thousand eight hundred and eighty eight dollars) which UCLB will then pay to MEEI in order to reimburse all of the costs and expenses incurred by MEEI in respect of drafting, applying for and prosecuting the Patents prior to 18 May 2016.

 

5.2 Milestone Payments

Within [***] ([***]) days following achievement of each of the following milestone events by Licensee, its Affiliates or Sub-licensees, the Licensee shall notify UCLB in writing that the relevant milestone event has been achieved, provide documentary evidence of such achievement as appropriate and pay to UCLB, within a period of [***] days, the amount(s) set out next to such milestone event below:

 

Milestone Event

   Amount to be paid  

[***]

   £ [ ***] 

[***]

   £ [ ***] 

 

5.3 Annual Management Fees

On each date referred to in the following table, the Licensee shall pay to UCLB the annual management fee set out next to such date in the table.

 

Date

   Amount to be paid  

Upon each anniversary of the Commencement Date until [***]

   £ 50,000  

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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5.4 Sales Linked Milestone Payments

Upon achievement of each of the sales linked milestones set out in the following table by the Licensee, its Affiliates or Sub-licensees, the Licensee shall notify UCLB in writing that the relevant sales linked milestone has been achieved, provide the relevant documentary evidence and pay to UCLB the amount(s) set out next to such event in the table:

 

Sales Linked Milestones

   Amount to be paid  

When Net Sales Value reaches £[***]

   £ [ ***] 

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £ [ ***] 

On the next £[***] of Net Sales Value (When sales cumulatively reach £[***])

   £ [ ***] 

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £ [ ***] 

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £ [ ***] 

On the next £[***] of Net Sales Value (when sales cumulatively reach £[***])

   £ [ ***] 

 

5.5 Royalties on Net Sales

For each Licensed Product in each country, the Licensee shall pay to UCLB a royalty of [***]% ([***] per cent) being a percentage of the Net Sales Value of all Licensed Products sold by Licensee, its Affiliates or Sub-licensees. The Licensee’s obligations to pay such royalty for a given Licensed Product in a given country shall begin after the First Commercial Sale of such Licensed Product in such country and shall end on the later to occur of the following: (a) expiration of the last Valid Claim of a Patent claiming such Licensed Product in such country; or (b) the tenth (10th) anniversary of the date of such First Commercial Sale in such country; or (c) the expiration of any Regulatory Exclusivity with respect to all Licensed Products in the relevant country.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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5.6 Intentionally omitted

 

5.7 Combination Products

If any Licensed Products are incorporated in any other product (“Combination Product”) sold by the Licensee or its Affiliates and the Licensed Product is not priced separately from the Combination Product, the Net Sales Value of such Licensed Product shall be deemed to be the fair market value of the Licensed Product in the country of sale when sold separately or if not sold separately in the country of sale, in comparable countries and territories or if neither of the foregoing apply, a reasonable amount which fairly reflects the value of the Licensed Product within the Combination Product assuming the Licensed Product is not being sold as a loss leader.

 

5.8 Payment Frequency

Royalties due under this Agreement, except for the payments due under Clauses 5.1, 5.2, 5.3 and 5.4, which are payable upon the date/time specified in Clauses 5.1, 5.2, 5.3, and 5.4 as appropriate, shall be paid within [***] ([***]) days following the end of each calendar quarter ending on 31 March, 30 June, 30 September and 31 December in each year, in respect of sales of Licensed Products made during such quarter, and within [***] ([***]) days following the termination of this Agreement.

 

5.9 Payment terms

All sums due under this Agreement:

 

  5.9.1 are exclusive of Value Added Tax which where applicable will be paid by the Licensee to UCLB in addition;

 

  5.9.2 shall be paid in pounds sterling in cash by transferring an amount in aggregate to the following Account name: UCL Business Plc, Sort Code: 20 10 53, Account number: 30782270, Address: Barclays Bank Plc, PO Box 11345, London, W12 8GG, and in the case of income or amounts received by the Licensee or its Affiliates in a currency other than pounds sterling, the royalty shall be calculated in the other currency and then converted into equivalent pounds sterling at the relevant daily spot rate for that currency as quoted in the Financial Times newspaper on the last business day of the quarter in relation to which the royalties are payable;

 

  5.9.3 will be made without any set-off, deduction or withholding except as may be required by law. If the Licensee is required by law to make any deduction or to withhold any part of any amount due to UCLB under this Agreement, the Licensee will give to UCLB proper evidence of the amount deducted or withheld and payment of that amount to the relevant taxation authority, and will do all things in its power to enable or assist UCLB to claim exemption from or, if that is not possible, to obtain a credit for the amount deducted or withheld under any applicable double taxation or similar agreement from time to time in force; and

 

  5.9.4 shall be made by the due date, failing which UCLB may charge interest on any outstanding amount on a daily basis at a rate equivalent to [***]% above the Bank of England pound sterling base rate then in force in London.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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5.10 Royalty Statements

The Licensee shall send to UCLB, at the same time as each royalty payment is made in accordance with Clause 5.5, a statement setting out for the relevant calendar quarter:

 

  5.10.1 in respect of each territory or region in which Licensed Products are sold;

 

  5.10.2 the types of Licensed Product sold;

 

  5.10.3 the quantity of each type sold;

 

  5.10.4 the total invoiced price for each type of Licensed Product sold;

 

  5.10.5 where relevant, details of any Licensed Products that have been sold other than on arm’s length terms for a cash consideration, including the relevant open market price or (if not available) the reasonable price attributed thereto;

 

  5.10.6 the amounts deducted from the Net Sales Value as referred to in paragraph (i) to (iv) of that definition (broken down on a product by product and category by category basis); and

 

  5.10.7 the aggregate royalties on Net Sales Value due to UCLB;

in each case expressed both in local currency and pounds sterling and showing the conversion rates used, during the period to which the royalty payment relates.

 

5.11 Records

The Licensee shall keep at its normal place of business detailed and up to date records and accounts showing the quantity, description and invoiced price or non-cash consideration for all Licensed Products sold by it or its Affiliates or on its or its Affiliates’ behalf, broken down in each case on a country by country basis, and being sufficient to ascertain the payments due to UCLB under this Agreement.

The Licensee shall make such records and accounts available, on reasonable notice, for inspection during business hours by an independent chartered accountant nominated by UCLB for the purpose of verifying the accuracy of any statement or report given by the Licensee to UCLB under this Clause 5.11. The Licensee shall co-operate reasonably with any such accountant, and shall promptly provide all information and assistance reasonably requested by such accountant. The accountant shall be required to keep confidential all information learnt during any such inspection, and to disclose to UCLB only such details as may be necessary to report on the accuracy of the Licensee’s statement or report. UCLB shall be responsible for the accountant’s charges unless the accountant certifies that there is an inaccuracy of more than [***]% ([***] percent) in any royalty statement, in which case the Licensee shall pay his charges in respect of that inspection.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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The Licensee shall ensure that UCLB has the same rights as those set out in this Clause 5.11 in respect of the Licensee’s Affiliates and Sub-licensees.

The Licensee shall co-operate with UCLB in good faith to resolve any discrepancies identified during any such inspection and shall pay any shortfall in the amounts paid to UCLB under this Agreement, together with interest on late payment as specified in Clause 5.9.4, within 30 days following receipt of a copy of the independent chartered accountant’s report.

 

5.12 Accounting Standards

Where this Agreement requires a financial calculation to be made or an action to be taken, such calculation or action will be made or taken in accordance with the generally accepted accounting principles from time to time approved by the United Kingdom’s Financial Reporting Council, or any successor body, applicable as at the date on which such calculation or action is made or taken.

 

6. COMMERCIALISATION

 

6.1 General Diligence

The Licensee shall use Diligent Efforts to develop and commercially exploit Licensed Products throughout the Territory (including obtaining all and any regulatory approvals which may be required to market and sell the Licensed Products) and to maximise sales for the benefit of both Parties.

 

6.2 Competing Activities

The Licensee shall notify UCLB in confidence if it or any of its Affiliates or its Sub-licensees commences any marketing, sale or commercialisation of any Competing Product or enters into an agreement with any other person with respect to any such activities.

 

6.3 Development Plan

The Licensee’s initial plan for developing and commercialising Licensed Products is set out in Schedule 5 (the “Initial Development Plan”). The Licensee shall provide to UCLB on each anniversary of the Commencement Date a written update to the Initial Development Plan that shall:

 

  6.3.1 report on all activities conducted under this Agreement by the Licensee and its Affiliates and Sub-licensees since the Commencement Date or the date of the previous update (as appropriate);

 

  6.3.2 (where applicable) set out the milestone events achieved since the Commencement Date or the date of the previous update (as appropriate) and the Licensee’s reasonable estimate of the dates for achieving any future milestone events;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  6.3.3 set out the current and projected activities being taken or planned to be taken by the Licensee and its Affiliates and Sub-licensees to bring Licensed Products to market, and to maximise the sale of Licensed Products in the Territory; and

 

  6.3.4 set out the Licensee’s projected sales of Licensed Products (based on the Licensee’s current forecasts) for each of the next [***] ([***]) years following the date of the report.

UCLB’s receipt or approval of any update to the Updated Development Plan shall not be taken to waive or qualify the Licensee’s obligations under Clause 6.1.

 

6.4 Annual Meeting

In respect of the Licensed Technology, the Licensee will on UCLB’s request meet with UCLB at least once per calendar year, following the submission of the update to the relevant Development Plan pursuant to Clause 6.3, to discuss progress with development and commercialisation of the Licensed Technology and where relevant the Licensee’s efforts to maximise sales of Licensed Products.

 

6.5 Reporting of First Commercial Sale

The Licensee will, for each Licenced Technology, promptly notify UCLB in writing of the First Commercial Sale of each Licensed Product on a commercial basis in each country within the Territory.

 

6.6 Reporting for Impact Purposes

 

  6.6.1 The Licensee acknowledges that part of UCLB’s purpose in licensing the Patents, Know-how and Materials to the Licensee pursuant this Agreement is to ensure that the Patents, Know-how and Materials are made available for use and commercial exploitation with the intention of benefitting society and the economy. In order to enable UCLB and UCL to monitor the benefit that they are providing, and to enable UCL to demonstrate the impact of its research activities, to society and the economy, the Licensee will upon request provide to UCLB [***], a written report describing in reasonable detail how it has used the Patents, Know-how and Materials, and the societal and economic benefits generated therefrom.

 

  6.6.2

UCLB shall notify and seek permission from the Licensee in advance, in writing if it wishes to use any written reports received from the Licensee (and the information contained therein) pursuant to Clause 6.6.1 in applications for research or other grant related funding and in submissions to Higher Education funding bodies such as HEFCE and/ or HEIF (or any replacements for either of those entities) and like entities, supplying a written copy of the application for research or other grant related funding or submission (or the relevant sections thereof). The Licensee will

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  respond to UCLB in writing within [***] ([***]) days of receipt of such written information and subject to the removal of any confidential information as notified in such written request by the Licensee, UCLB and UCL shall be entitled to submit the approved applications for research or other grant related funding and in submissions to Higher Education funding bodies such as HEFCE and/ or HEIF (or any replacements for either of those entities) and like entities.

 

6.7 Quality

The Licensee shall ensure that all of the Licensed Products marketed by it and its Affiliates and Sub-licensees are of satisfactory quality and comply with all applicable laws and regulations in each part of the Territory.

 

6.8 Marking of Licensed Products

To the extent permitted under the laws of any country, the Licensee shall mark and cause its Affiliates and Sub-Licensees to mark each Licensed Product with the number of each issued Patent which applies to the Licensed Product and a statement that such Licensed Products are sold under licence from UCL Business plc.

 

6.9 Disposals of Licensed Products for Free

Notwithstanding the terms of Clause 6.1, the Licensee shall be entitled to supply a reasonable number of Licensed Products to third parties free of charge as promotional items for the purpose of establishing a market for the Licensed Products in the relevant country or territory or for research, evaluation and testing purposes, or for clinical development, provided that the quantity of Licensed Products supplied for free (or for the cost of manufacture) in each country or territory is not excessive and is in line with normal industry practice in such country or territory. Any Licensed Products disposed of to third parties in accordance with this Clause 6.9 shall not be taken into account for the purposes of calculating Net Sales Value.

 

6.10 Referral to Expert

If UCLB considers at any time during the period of this Agreement that the Licensee has failed to comply with its obligations under Clause 6.1 or 6.3, then the matter shall be referred to an independent expert to answer the following questions:

 

  6.10.1 whether the Licensee has complied with its obligations under Clause 6.1 or 6.3; and if not

 

  6.10.2 what specific action the Licensee should have taken and/or now needs to take (“Specific Action”) in order to fulfil such obligations and within what period the Specific Action should be taken (“Action Period”).

The independent expert shall be appointed in accordance with the provisions of Schedule 2 and his decision shall be final and binding on the Parties.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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6.11 Consequences of Expert’s Decision

If the expert determines that the Licensee has failed to comply with its obligations under Clause 6.1 or 6.3, and if the Licensee fails to take the Specific Action within the Action Period, UCLB shall be entitled, by giving, at any time within [***] ([***]) months after the end of that Action Period, not less than [***] ([***]) months’ notice, to (a) convert the licence granted under Clause 2.1.1 into a non-exclusive licence or (b) terminate this Agreement.

 

6.12 Use and sale in United States

The Licensee agrees that for use and sale of the rights under the Patents in the United States, any products embodying the Patents, or produced through use of the Patents, shall be manufactured substantially in the United States, unless a waiver is granted by the NIH. UCLB shall use reasonable efforts, and shall ensure that MEEI use reasonable efforts to assist in the preparation and obtaining of such a waiver, if requested in writing by Licensee and at Licensee’s reasonable expense.

 

7. ACCESS TO MEDICINES AND ETHICAL LICENSING

 

7.1 General Diligence

The Licensee agrees to use Diligent Efforts to develop and commercially exploit Licensed Products in a manner consistent with ethical and socially responsible licensing principles, including requiring all Sub-licensees and other parties involved in the development and commercial exploitation of Licensed Products to agree in writing to comply with ethical and socially responsible licensing principles.

 

7.2 Supply to Developing Countries

 

  7.2.1 Supply by the Licensee

The Licensee shall use Diligent Efforts to supply the Licensed Products to customers in At-Cost Markets at a Cost-Based Price and to meet market demand for the Licensed Products in those markets.

 

  7.2.2 Sub-Licensing in Developing Country markets

If the Licensee is unable to supply the Licensed Product at a Cost-Based Price in any At-Cost Market and to meet market demand for the Licensed Products in those markets, it shall use Diligent Efforts to license one or more Developing Country Manufacturers on Reasonable Developing Country License Terms to manufacture, distribute and sell the Licensed Product at a Cost-Based Price in that At-Cost Market.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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7.3 Reporting

The Licensee shall keep UCLB regularly updated regarding the Licensee’s efforts to supply the Licensed Products in accordance with the requirements outlined in Clauses 7.1 and 7.2.

 

7.4 Step In Rights

 

  7.4.1 If at any time UCLB acting reasonably considers that the Licensee is not meeting its obligations under Clauses 7.1 and 7.2 in relation to the supply of the Licensed Products to customers in At-Cost Markets, UCLB may be written notice require the Licensee to seek one or more third parties to develop, commercialise and supply the Licensed Products to customers in At-Cost Markets.

 

  7.4.2 If the Licensee following a written requirement from UCLB refuses to grant a sub-license to or is unable to identify a third party to develop, commercialise and supply the Licensed Products to customers in At-Cost Markets, then UCLB notwithstanding the rights granted to the Licensee under this Agreement shall have the right to seek a third party and/ or to grant to a third party a license to manufacture, have manufactured, use, sell, offer for sale and import the Licensed Products for supply in the At-Cost market on Reasonable Developing Country License Terms.

 

8. COMPLIANCE WITH LAWS

 

8.1 General Compliance with Laws

The Licensee will at all times (and will ensure its Affiliates and Sub-licensees) comply with all legislation, rules, regulations and statutory requirements applying to and obtain any consents necessary for its use of the Patents, the Know-how and the Materials , the development, manufacture, and sale of Licensed Products in any country or territory.

 

8.2 Bribery Act

The Licensee shall (and shall procure that any persons associated with it engaged in the performance of this Agreement including its Affiliates and Sub-licensees shall):

 

  8.2.1 comply with all applicable laws and codes of practice relating to anti-bribery and anti-corruption including the Bribery Act 2010 and without prejudice to the foregoing generality, shall not engage in any activity, practice or conduct which would constitute an offence under sections 1, 2 or 6 of the Bribery Act 2010 or do or omit to do any act that will cause or lead UCLB to be in breach of the Bribery Act 2010;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  8.2.2 comply with UCLB’s ethics, anti-bribery and anti-corruption policies as notified to the Licensee from time to time and have, maintain in place and enforce throughout the term of this Agreement adequate procedures to ensure compliance with Clause 8.2.1; and

 

  8.2.3 promptly report to UCLB any request or demand for any undue financial or other advantage of any kind received in connection with the performance of this Agreement.

For the purpose of this Clause 8.2, the meaning of adequate procedures and whether a person is associated with another person shall be determined in accordance with the Bribery Act 2010 (and any guidance issued under section 9 of that Act). Breach of this Clause 8.2 shall be deemed a material breach of this Agreement entitling UCLB to terminate under Clause 12.2.1.

 

8.3 Export Control Regulations

The Licensee shall ensure that, in using the Patents, Know-how or Materials and in selling Licensed Products, it and its Affiliates, employees, sub-contractors and Sub-licensees comply fully with any United Nations trade sanctions or EU or UK legislation or regulation, from time to time in force, which impose arms embargoes or control the export of goods, technology or software, including weapons of mass destruction and arms, military, paramilitary and security equipment and dual-use items (items designed for civil use but which can be used for military purposes) and certain drugs and chemicals.

 

9. INTELLECTUAL PROPERTY

 

9.1 Obtain and Maintain the Patents

 

  9.1.1 The Licensee shall be responsible for the drafting, filing, prosecution and maintenance of all of the Patents at the Licensee’s cost and expense. Subject to resource availability, UCLB shall use commercially reasonable efforts to provide such assistance as the Licensee may request to prosecute and maintain the Patents[***] that may be incurred in providing such assistance.

 

  9.1.2 The Patents will be filed, prosecuted and maintained in the countries and territories set out in Schedule 4. The Licensee shall notify UCLB of any decisions as to which (if any) additional countries to file and maintain Patents in.

 

  9.1.3

The Licensee shall consult with UCLB in relation to all material changes to the patent claims or specifications that would have the effect of reducing or limiting the scope of the Patents, and not make any such changes without the prior written consent of UCLB. Such consent shall not be unreasonably withheld or delayed provided that UCLB has been given as much notice as is practicable, and in any event no less than [***] days’ notice (or such shorter period for response dictated by the relevant patent office) of such proposed changes, and has been given an opportunity to file divisionals, continuations and/or such other types of protection to cover any claims or subject matter that the Licensee intends to remove from the

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  scope of the Patents. If UCLB fails to respond before the end of the [***] day period (or such shorter period for response dictated by the relevant patent office), the Licensee may proceed with the proposed changes to the patent claims or specifications. The Licensee will ensure that UCLB receives copies of all correspondence to and from Patent Offices in respect of the Patents, including copies of all documents generated in or with such correspondence, and shall be given reasonable notice (or such shorter period for response dictated by the relevant patent office) of and the opportunity to participate in any conference calls or meetings with the Licensee’s patent attorneys in relation to the drafting, filing, prosecution and maintenance of the Patents, so that UCLB may be continuously informed of progress with the drafting, filing, prosecution and maintenance of the Patents. Such involvement of UCLB under this Clause 9.1.3 shall be at UCLB’s cost and expense.

 

  9.1.4 If the Licensee wishes to abandon any application contained with the Patents or not to maintain any such Patent, it shall give [***] ([***]) months’ prior written notice to UCLB and on the expiry of such notice period the licences of the relevant Patents granted to the Licensee under this Agreement shall cease.

 

  9.1.5 In the event that any of rights granted hereunder become non-exclusive, responsibility for the drafting, filing, prosecution and maintenance of all of the Patents shall revert to UCLB.

 

9.2 Infringement of the Patents, the Know-how and/or the Materials

 

  9.2.1 Each Party shall promptly give to the other Party and MEEI written notice if it becomes aware of any infringement or potential infringement of any of the Patents or any unauthorised use of the Know-how or the Materials or any challenge to the validity or ownership of the Patents, the Know-how or the Materials and the Parties shall consult with each other and MEEI to decide the best way to respond to such infringement, unauthorised use or challenge.

 

  9.2.2 The Licensee shall have the primary obligation and right to take action against any third party alleged to be infringing the Patents or making unauthorised use of the Know-how or the Materials and to defend the Patents against challenges to validity or ownership at its sole expense, provided that:

 

  (a) the Licensee, UCLB and MEEI, in cooperation with the NIH, shall use their commercially reasonable efforts to eliminate the infringement without litigation. If the efforts of the Licensee, UCLB and MEEI are not successful in eliminating the infringement within [***] ([***]) days after the infringer has been formally notified of the infringement by the Licensee, the Licensee shall have the right, after consulting with the MEEI, NIH and UCLB, to commence suit on its own account;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (b) UCLB shall procure that MEEI shall and that MEEI shall procure that the NIH shall on the Licensee’s or UCLB’s request cooperate with the Licensee in such action [***], provided that the Licensee shall not be required under this Clause 9.2.2 to [***]; and

 

  (c) UCLB shall on the Licensee’s request cooperate with the Licensee in such action [***]; and

 

  (d) the Licensee shall be solely responsible for the conduct of the action or for settlement thereof and shall be entitled to all damages received from such action, subject to Clause 9.2.4.

 

  9.2.3 Before starting or defending or settling any legal action under Clause 9.2.2, the Licensee shall consult with UCLB as to the advisability of the action or defence or settlement, its effect on the good name of UCLB, the public interest, and how the action or defence should be conducted.

 

  9.2.4 The Licensee shall [***] in such action or defence.

 

  9.2.5 UCLB shall if reasonably requested by the Licensee agree to be joined in any suit to enforce such rights or will take such action in its own name [***] and shall have the right to be separately represented by its own counsel [***]. Notwithstanding the foregoing, [***].

 

  9.2.6 UCLB shall procure that MEEI shall and that MEEI shall procure that the NIH shall if reasonably requested by UCLB or the Licensee agree to be joined in any suit to enforce such rights or will take such action in its or their own name(s) [***]. Notwithstanding the foregoing, [***], provided that [***].

 

  9.2.7 If, within [***] of the Licensee or UCLB giving to the other and MEEI written notice or receiving written notice from the other or MEEI of any potential infringement of the Patents, the Licensee and UCLB are both unsuccessful in persuading the alleged infringer to desist or fail to initiate an infringement action, MEEI shall have the right, at its sole discretion, to prosecute such infringement under its sole control and [***].

 

9.3 Infringement of Third Party Rights

 

  9.3.1 If any warning letter or other notice of infringement is received by a Party, or legal suit or other action is brought against a Party, alleging infringement of third party rights in the manufacture, use or sale of any Licensed Product or use of any Patents, Know-how or Materials, that Party shall promptly provide full details to the other Party, and Licensee and UCLB shall discuss the best way to respond with MEEI.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  9.3.2 The Licensee shall have the right but not the obligation to defend such suit to the extent it relates to Licensee’s or its Affiliates’ or Sub-licensee’s activities and shall have the right to settle with such third party, provided that [***]. In the event that the Licensee, Affiliates or Sub-licensees do not take forward an action, UCLB shall have the right, at its sole discretion, to defend such suit under its sole control and [***].

 

10. WARRANTIES AND LIABILITY

 

10.1 Warranties by UCLB

UCLB warrants and undertakes as follows to its reasonable knowledge and without having undertaken any due and careful enquires whether specific or general in nature:

 

  10.1.1 It, MEEI and NIH are the owners of the Patents;
 
  10.1.2 it has the authority to grant the licences under this Agreement; and.
 
  10.1.3 so far as it is aware (having made no enquiry of any third parties or conducted any freedom to operate searches), use and exploitation of the Patents will not infringe the intellectual property rights of any third party.

 

10.2 Warranties by the Licensee

The Licensee warrants and undertakes that:

 

  10.2.1 it has the right and authority to enter into this Agreement;
 
  10.2.2 so far as it is aware (having made no enquiry of any third parties), use and exploitation of the Patents will not infringe the intellectual property rights of any third party;
 
  10.2.3 neither it nor any of its Affiliates is currently researching, developing, marketing, selling or otherwise commercialising any Competing Product (“Competing Activities”), nor has any of them entered into an agreement with any other person with respect to any Competing Activities; and
 
  10.2.4 it shall notify UCLB if it or any of its Affiliates or its Sub-licensees commences any Competing Activities or enters into an agreement with any other person with respect to any Competing Activities.

 

10.3 Acknowledgements

The Licensee acknowledges that:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  10.3.1 the inventions claimed in the Patents, and the Know-how and the Materials are at an early stage of development. Accordingly, specific results cannot be guaranteed and any results, materials, information or other items (together “Delivered Items”) provided under this Agreement are provided “as is” and without any express or implied warranties, representations or undertakings. As examples, but without limiting the foregoing, UCLB does not give any warranty that Delivered Items are of merchantable or satisfactory quality, are fit for any particular purpose, comply with any sample or description, or are viable, uncontaminated, safe or non-toxic.
 
  10.3.2 UCLB has not performed any searches or investigations into the existence of any third party rights that may affect any of the Patents, Know-how or Materials or the use and exploitation of any of the Patents, Know-how or Materials

 

10.4 No Other Warranties

 

  10.4.1 Each of the Parties acknowledges that, in entering into this Agreement, it does not do so in reliance on any representation, warranty or other provision except as expressly provided in this Agreement, and any conditions, warranties or other terms implied by statute or common law are excluded from this Agreement to the fullest extent permitted by law.
 
  10.4.2 Without limiting the scope of Clause 10.4.1, UCLB does not make any representation nor give any warranty or undertaking:

 

  (a) express or implied, including, without limitation, any implied warranties of merchantability or of fitness for a particular purpose with respect to any Patent, trademark, software, non-public or other information, or tangible research property, licensed or otherwise provided to the Licensee hereunder and hereby disclaims the same;

 

  (b) as to the efficacy or usefulness of the Patents, Know-how or Materials; or

 

  (c) whatsoever with regard to the scope of any of the Patents or that any of the Patents is or will be valid or (in the case of an application) will proceed to grantor that such Patents may be exploited by the Licensee, Affiliate or Sub-licensee without infringing other patents; or

 

  (d) that the Materials or the methods used in making or using the Materials are free from liability for patent infringement; or

 

  (e) that the use of any of the Patents, Know-how or Materials Licensed Technologies, the manufacture, sale or use of the Licensed Products, or the exercise of any of the rights granted under this Agreement will not infringe any intellectual property or other rights of any other person; or

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (f) that the Know-how or any other information communicated by UCLB to the Licensee under or in connection with this Agreement will produce Licensed Products of satisfactory quality or fit for the purpose for which the Licensee intended or that any product will not have any defect, latent or otherwise, and whether or not discoverable by inspection; or

 

  (g) as imposing any obligation on UCLB to bring or prosecute actions or proceedings against third parties for infringement or to defend any action or proceedings for revocation of any of the Patents; or

 

  (h) as imposing any liability on UCLB in the event that any third party supplies Licensed Products to customers located in the Territory; or

 

  (i) that there will be no similar or competitive products or services manufactured, used, sold or supplied by any third party in the Territory.

 

10.5 Responsibility for Development of Licensed Products

The Licensee shall be exclusively responsible for its and its Affiliates’ and Sub-licensees’ use of the Patents, Know-how and Materials, the technical and commercial development and manufacture of Licensed Products and for incorporating any modifications or developments thereto that may be necessary or desirable, for all Licensed Products sold or supplied, notwithstanding any consultancy services or other contributions that UCLB and/or UCL may provide in connection with such activities.

 

10.6 Indemnity

The Licensee shall indemnify each of UCLB and UCL, and each of their respective officers, directors, Council members, employees and representatives (together, the “Indemnitees”) against all third party Claims that may be asserted against or suffered by any of the Indemnitees and which relate to:

 

  10.6.1 the use by the Licensee or any of its Affiliates or Sub-licensees of any of the Patents, Know-how or Materials; or

 

  10.6.2 the development, manufacture, use, marketing or sale of, or any other dealing in, any of the Licensed Products, by or on behalf of the Licensee or any of its Affiliates or Sub-licensees, or subsequently by any customer or any other person, including claims based on product liability laws.

The indemnity given by the Licensee to each Indemnitee under this Clause 10.6 will not apply to any third party Claim to the extent that it is attributable to the negligence, gross negligence, reckless misconduct or intentional misconduct of any Indemnitee.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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10.7 Indemnification and Defence

 

  10.7.1 Licensee shall indemnify, defend and hold harmless MEEI and its trustees, officers, medical and professional staff, employees and agents and their respective successors, heirs and assigns (the “MEEI Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation) incurred by or imposed upon the MEEI Indemnitees or any one of them in connection with any third party claims, suits, actions, demands or judgments: arising out of any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability) concerning any product, process or service made, used or sold or any right or license granted under this Agreement.

 

  10.7.2 Licensee’s indemnification under this Clause 10.7 shall not apply to liability, damage, loss or expense to the extent that it is directly attributable to the negligent activities, reckless misconduct or intentional misconduct of the MEEI Indemnitees.
 
  10.7.3 Licensee agrees, at its own expense, to provide attorneys reasonably acceptable to MEEI to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.
 
  10.7.4 This Clause 10.7 shall survive expiration or termination of this Agreement.

 

10.8 Limitations of Liability

 

  10.8.1 To the extent that UCLB or any of its Affiliates has any liability in contract, tort, or otherwise under or in connection with this Agreement, including any liability for breach of warranty, their liability shall be limited in accordance with the following provisions of this Clause 10.8.
 
  10.8.2 The aggregate liability of UCLB and any of its Affiliates shall be limited to the total income that UCLB has received from the Licensee pursuant to this Agreement (but excluding any other costs or expenses associated with drafting, filing, prosecuting, maintaining or defending any Patents or providing any assistance to the Licensee) during the period of [***] ([***]) years preceding the date on which the liability arises, or [***] pounds (£[***]) sterling, whichever is the higher.
 
  10.8.3 The liability of the Licensee to UCLB shall be limited to the limit of its insurance as set out in Clause 10.9.1, except that in the case of product liability, the liability of the Licensee under this Agreement shall be unlimited.
 
  10.8.4

In no circumstances shall either Party or any Indemnitee be liable for any loss, damage, costs or expenses of any nature that is (a) of an indirect, special or consequential nature or (b) any loss of profits (whether direct or indirect), revenue, business opportunity or goodwill, which arises directly or indirectly from that Party’s breach or non performance of this Agreement, or negligence in the performance of

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  this Agreement or from any liability arising in any other way out of the subject matter of this Agreement even if the Party bringing the claim has advised the other Party or the relevant Indemnitee of the possibility of those losses arising, or if such losses were within the contemplation of the Parties or the Indemnitee.

 

  10.8.5 Nothing in this Agreement excludes either Party’s liability to the extent that it may not be so excluded under applicable law, including any such liability for death or personal injury caused by that Party’s negligence, or liability for fraud or fraudulent misrepresentation.

 

10.9 Insurance: UCLB Requirements

 

  10.9.1 The Licensee shall take out with a reputable insurance company and maintain at all times during the term of this Agreement public and product liability and professional indemnity insurance including against all loss of and damage to property (whether real, personal or intellectual) and injury to persons including death arising out of or in connection with this Agreement and the Licensee’s and its Affiliates’ and Sub-licensees’ use of the Patents, Know-how or Materials and use, sale of or any other dealing in any of the Licensed Products. Such insurances may be limited in respect of one claim provided that such limit must be at least [***] pounds (£[***]) sterling, unless the Licensee commences any business in manufacturing, distribution, supply or otherwise make available to the public any products, in which case such limit must be at least [***] pounds (£[***]) sterling. Such insurance shall continue to be maintained for a further [***] years from the end of this Agreement.
 
  10.9.2 The Licensee will produce to UCLB at all times upon demand proof that the insurance cover required pursuant to Clause 10.9.1 is in force and evidence that all premiums have been paid up to date. If UCLB becomes aware that the Licensee has failed to maintain the insurance required pursuant to Clause 10.9.1, UCLB may effect such insurance and the Licensee will reimburse UCLB for the reasonable cost of effecting and maintaining such insurance on demand.

 

11. INSURANCE: MEEI REQUIREMENTS

 

  11.1.1 Beginning no later than the time any Licensed Products are being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee or by a Sub-licensee, affiliate or agent of Licensee, Licensee shall, at its own cost and expense procure and maintain Commercial General Liability (CGL) insurance or other coverage acceptable to MEEI in amounts not less than $[***] per incident or occurrence and $[***] annual aggregate and naming the MEEI Indemnitees as additional insureds. Such CGL or other insurance shall provide:

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Confidential Treatment Requested by MeiraGTx Holdings plc

 

  (a) Product liability coverage, and

 

  (b) Contractual liability coverage for Licensee’s indemnification under Clause 10.7 of this Agreement.

 

  11.1.2 If Licensee elects to self-insure all or parts of the limits described above (including deductibles or retentions which are in excess of $[***] annual aggregate) such self-insurance program must be acceptable to MEEI and CRICO. The minimum amount of insurance coverage required under this Clause 11.1 shall not be construed to create a limit of Licensee’s liability with respect to its indemnification under Clause 10.7 of this Agreement. Licensee shall provide MEEI with written evidence of such insurance upon request of MEEI. Licensee shall provide MEEI with written notice at least [***] ([***]) days prior to the cancellation, non-renewal or material change in such insurance, if:

 

  (a) Licensee does not obtain replacement insurance providing comparable coverage within such [***] ([***]) day period, MEEI shall have the right to terminate this Agreement effective at the end of such [***] ([***]) days without notice of any additional waiting period.

 

  11.1.3 Licensee shall maintain such CGL or other insurance during:

 

  (a) the period that any Licensed Products are being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee or by a Sub-licensee, affiliate or agent of Licensee;

 

  (b) reasonable period after the period referred to in Clause 11.1.3 (a) above, which in no event shall be less than [***] ([***]) years.

 

  11.1.4 This Clause 11.1 shall survive expiration or termination of this Agreement.

 

12. DURATION AND TERMINATION

 

12.1 Commencement and Expiry

This Agreement and the licences granted hereunder, shall come into effect on the Commencement Date and, unless terminated earlier in accordance with this Clause 12, the licences granted hereunder shall continue in force on a country by country basis until the later of the last payment obligation of Licensee expires under this Agreement. Upon such expiry, Licensee’s licenses under this Agreement shall become full-paid, perpetual and irrevocable.

 

12.2 Early Termination

Each Party (the “Terminating Party”) may terminate this Agreement at any time by notice in writing to the other Party (“Other Party”), such notice to take effect as specified in the notice:

 

  12.2.1 if the Other Party is in material breach of this Agreement and, in the case of a breach capable of remedy within thirty (30) days, the breach is not remedied within thirty (30) days of the Other Party receiving notice specifying the breach and requiring its remedy; or

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  12.2.2 if:

 

  (a) the Other Party becomes insolvent or unable to pay its debts as and when they become due;

 

  (b) an order is made or a resolution is passed for the winding up of the Other Party (other than voluntarily for the purpose of solvent amalgamation or reconstruction);

 

  (c) a liquidator, administrator, administrative receiver, receiver or trustee is appointed in respect of the whole or any part of the Other Party’s assets or business;

 

  (d) the Other Party makes any composition with its creditors;

 

  (e) the Other Party ceases to continue its business; or

 

  (f) any event analogous to the events referred to in paragraphs (a) to (e) above occurs in any other jurisdiction.

 

  12.3 UCLB may terminate this Agreement by giving written notice to the Licensee, such termination to take effect forthwith or as otherwise stated in the notice:

 

  12.3.1 if there is any change of Control of the Licensee involving the categories of persons or Affiliates of persons prohibited by Clause 2.3; or

 

  12.3.2 the Licensee is in persistent breach of the Agreement and where the Parties have failed to agree a mechanism to remedy the persistent nature of such breaches within a reasonable period following UCLB notifying the Licensee of the persistent breach and requesting that the Licensee enters into discussions with UCLB as to mechanisms for remedying the persistent breaches or if the Parties have agreed a mechanism to remedy the persistent breach but that mechanism if not fully complied with by the Licensee; or

 

  12.3.3 if the Licensee shall enter into any sub-licence with any of the categories of persons or Affiliates of persons prohibited by Clause 2.3 which may, adversely affect UCL’s and/or UCLB’s reputation.

 

  12.4 A Party’s right of termination under this Agreement, and the exercise of any such right, shall be without prejudice to any other right or remedy (including any right to claim damages) that such Party may have in the event of a breach of contract or other default by the other Party.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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12.5 Consequences of Termination

 

  12.5.1 Upon expiry of the period of this Agreement, and subject to all royalties and any other sums due to UCLB under this Agreement having been duly paid, the Licensee shall have a fully paid up licence to the Patents, the Know-how and the Materials of the same scope as set forth in Clauses 2.1.1 and 2.1.2 without any further obligation to pay any further sums to UCLB under Clause 5. Notwithstanding the foregoing the Licensee acknowledges that once each Patent expires or is abandoned or withdrawn or allowed to lapse in any country or territory, third parties in that country or territory will be entitled to use the inventions claimed in the Patent and that accordingly the licence granted to the Licensee under Clause 2.1.1 will no longer be exclusive in that country or territory.

 

  12.5.2 Upon termination of this Agreement by UCLB under Clause 12.2.1 (for Licensee’s uncured material breach) or under Clause 12.3:

 

  (a) the Licensee and its Affiliates and Sub-licensees shall be entitled to sell, use or otherwise dispose of (subject to payment of royalties under Clause 5) any unsold or unused stocks of the Licensed Products for a period of six (6) months following the date of termination;

 

  (b) subject to paragraph (a) above, any license that has not become fully paid-up in accordance with Clause 12.1 shall terminate and the Licensee and its Affiliates (and subject to Clause 2.3, its Sub-licensees) shall no longer be licensed to use or otherwise exploit the Patents and/or the Know-how and/or the Materials, in so far and for as long as any of the Patents remains in force and the Know-how remains confidential;

 

  (c) the Licensee shall consent to the cancellation of any formal licence granted to it, or of any registration of it in any register, in relation to any of the Patents;

 

  (d) the Licensee will, promptly on UCLB’s request, provide (and will ensure that its patent agents provide) to UCLB all information, documentation and assistance (including executing documents) which UCLB may reasonably require to enable it to continue with the drafting, filing, prosecution and maintenance of the Patents;

 

  (e) except as set out in Clause 2.3, all sub-licences of the Patents and/or the Know-how and/or the Materials granted by the Licensee pursuant to this Agreement will automatically terminate;

 

  (f) each Party shall upon the written request of the other Party, return or destroy any documents or other materials that are in its or its Affiliates possession or under its or their control and that contain the other Party’s Confidential Information.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  12.6 If Licensee may terminate this Agreement under Clause 12.2.1 (for UCLB or its Affiliates uncured material breach), then Licensee may elect, in lieu of terminating the entire Agreement, to have all licenses granted under this Agreement survive, subject to Licensee’s fulfilment of [***] percent ([***]%) of its payment obligations under Clause 5 after what would have been the effective date of such termination.

 

  12.7 Upon termination of this Agreement for any reason, the provisions of Clauses 1, 2.3, 2.5, 3.2 to 3.6, 5 (in respect of amounts paid and payable to UCLB in respect of the period up to an including the date of termination) 6.6, 8, 10, 12.5, 12.6, 12.7 and 13 of this Agreement shall remain in force.

 

13. GENERAL

 

13.1 Force Majeure

 

  13.1.1 Any delays in or failure of performance by either Party under this Agreement will not be considered a breach of this Agreement and if and to the extent that such delay or failure is caused by occurrences beyond the reasonable control of that Party including acts of God; acts, regulations and laws of any government; strikes or other concerted acts of workers; fire; floods; explosions; riots; wars; rebellion; and sabotage; and any time for performance hereunder will be extended by the actual time of delay caused by any such occurrence.

 

  13.1.2 If either Party is prevented from carrying out its obligations:

 

  (a) under this Agreement for a continuous period of [***] ([***]) months the other Party may terminate this Agreement on giving [***] ([***]) days prior written notice provided always that at the date upon which termination becomes effective the Party which was prevented from carrying out its obligations under this Agreement remains so prevented.

 

13.2 Amendment

This Agreement may only be amended in writing signed by duly authorised representatives of UCLB and the Licensee.

 

13.3 Assignment and Third Party Rights

 

  13.3.1 Subject to Clause 13.3.3, the Licensee shall not assign, mortgage, charge or otherwise transfer any rights or obligations under this Agreement, nor any of the Patents, Know-how or Materials, without the prior written consent of UCLB.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  13.3.2 UCLB may assign all its rights and obligations under this Agreement together with its rights in the Patents, Know-how and Materials to any third party.

 

  13.3.3 The Licensee, subject to obtaining the consent of UCLB which shall not be unreasonably withheld or delayed (except in relation to those categories of persons or Affiliates of persons prohibited by Clause 2.3), may assign all its rights and obligations under this Agreement together with its rights in the Patents, Know-how and Materials to any third party to which it transfers all or substantially all of its assets or business, provided that the assignee undertakes to UCLB to be bound by and perform the obligations of the assignor under this Agreement. However the Licensee shall not have such a right to assign this Agreement if it is insolvent.

 

13.4 Waiver

Any waiver given under or in relation to this Agreement shall be in writing and signed by or on behalf of the relevant Party. No failure or delay on the part of either Party to exercise any right or remedy under this Agreement shall be construed or operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude the further exercise of such right or remedy.

 

13.5 Invalid Clauses

If any provision or part of this Agreement is held to be invalid, amendments to this Agreement may be made by the addition or deletion of wording as appropriate to remove the invalid part or provision but otherwise retain the provision and the other provisions of this Agreement to the maximum extent permissible under applicable law.

 

13.6 No Agency

Neither Party shall act or describe itself as the agent of the other, nor shall it make or represent that it has authority to make any commitments on the other’s behalf.

 

13.7 Interpretation

In this Agreement:

 

  13.7.1 the headings are used for convenience only and shall not affect its interpretation; references to persons shall include incorporated and unincorporated persons; references to the singular include the plural and vice versa; and references to the masculine include the feminine;

 

  13.7.2 references to Clauses and Schedules mean clauses of, and schedules to, this Agreement;

 

  13.7.3 references in this Agreement to termination shall include termination by expiry;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  13.7.4 where the word “including” is used it shall be understood as meaning “including without limitation”;

 

  13.7.5 any reference to any English law term for any action, remedy, method or judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall in respect of any jurisdiction other than England be deemed to include what most nearly approximates in that jurisdiction to the English law term;

 

  13.7.6 where there is any conflict or inconsistency between the main body of this Agreement and any of the schedules, then the main body of the Agreement shall prevail;

 

  13.7.7 time shall be of the essence in relation to the performance of the Licensee’s obligations under this Agreement; and

 

  13.7.8 any reference to the sale of a Licensed Product by the Licensee or its Affiliates or Sub-licensees will be taken to include any supply or other disposal of Licensed Products, and the term sold shall be construed accordingly.

 

13.8 Notices. Addresses for Service

 

  13.8.1 Any notice to be given under this Agreement shall be in English, in writing and shall be delivered by first class recorded delivery mail (if sent to an inland address) or by international courier (if sent to an address outside of the United Kingdom), to the address of the relevant Party set out at the head of this Agreement, or such other address as that Party may from time to time notify to the other Party in accordance with this Clause 13.8.

 

  13.8.2 Notices sent as above shall be deemed to have been received [***] ([***]) working day after the day of posting in the case of delivery inland first class recorded delivery mail, or [***] ([***]) working days after the date of collection by the international courier.

 

13.9 Law and Jurisdiction

The validity, construction and performance of this Agreement, and any contractual and non-contractual claims arising hereunder, shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the Parties hereby submit, except that a Party may seek an interim injunction (or an equivalent remedy) in any court of competent jurisdiction.

 

13.10 Entire Agreement

This Agreement, including its Schedules, sets out the entire agreement between the Parties relating to its subject matter and supersedes all prior oral or written agreements, arrangements or understandings between them relating to such subject matter. Subject to Clause 10.8.5, the Parties acknowledge that they are not relying on any representation, agreement, term or condition which is not set out in this Agreement.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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13.11 Third Parties

Except for the rights of UCL, MEEI and NIH as provided in Clause 2.4, the rights of the Indemnitees as provided in Clause 10.6, the rights of MEEI Indemnitees as provided in Clause 10.7, the limitations of liability afforded to the Indemnitees pursuant to Clause 10.8, the rights of MEEI under Clause 11.1.2 and the rights of MEEI and NIH under Clause 9, who may in their own right enforce and rely on the provisions of those Clauses, this Agreement does not create any right enforceable by any person who is not a party to it (“Third Party”) under the Contracts (Rights of Third Parties) Act 1999, but this Clause 13.11 does not affect any right or remedy of a Third Party which exists or is available apart from that Act. The Parties may amend, renew, terminate or otherwise vary all or any of the provisions of this Agreement, including Clauses 2.4, 9, 10.6 and 10.7, and 10.8, without the consent of MEEI, NIH and/or the MEEI Indemnitees.

 

13.12 Non-use of Names; Announcements

 

  13.12.1 The Licensee shall not use, and shall ensure that its Affiliates and Sub-licensees do not use, the name, any adaptation of the name, any logo, trademark or other device of UCLB, nor of the inventors named on the Patents nor the Principal Investigators in any advertising, promotional or sales materials without prior written consent obtained from UCLB in each case, except that the Licensee may state that it is licensed by UCLB under the Patents.

 

  13.12.2 Except as permitted under Clauses 3.4.1 and 6.6, neither Party shall make any press or other public announcement concerning any aspect of this Agreement, or make any use of the name or trade marks of the other Party in connection with or in consequence of this Agreement, without the prior written consent of the other Party.

 

13.13 Escalation

If the Parties are unable to reach agreement on any issue concerning this Agreement or the Project within [***] days after one Party has notified the other of that issue, they will refer the matter to the [***] in the case of UCLB, and to the [***] in the case of the Licensee in an attempt to resolve the issue within the time specified elsewhere in this Agreement in the case of other disputes. Either Party may bring proceedings in a court of competent jurisdiction if the matter has not been resolved within that prescribed period, and either Party may apply to the court for an injunction, whether or not any issue has been escalated under this Clause 13.13.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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EXECUTED on the date set out at the head of this Agreement.

 

For and on behalf of

 

UCL Business PLC

    

For and on behalf of

 

MEIRAGTX UK II LIMITED

/s/ Anne Lane

    

/s/ Richard Giroux

Signed      Signed

    Anne Lane

    

    Richard Giroux

Print name      Print name

    Executive Director

    

    Chief Operating Officer

Title      Title

    10/8/17

    

    August 16, 2017

Date      Date

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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SCHEDULE 1

LICENSED TECHNOLOGY

Part A: The Patents

[***]

Part B: The Know-how

[***]

Part C: The Materials

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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SCHEDULE 2

APPOINTMENT OF EXPERT

If either Party wishes to appoint an independent expert (the “Expert”) to determine any matter pursuant to any Clause of this Agreement, the following procedures will apply:

 

1. The Party wishing to appoint the Expert (“the Appointing Party”) will serve a written notice on the other Party (“the Responding Party”). The written notice will specify the Clause pursuant to which the appointment is to be made and will contain reasonable details of the matter(s) which the Appointing Party wishes to refer to the Expert for determination

 

2. The Parties shall within [***] ([***]) days following the date of the Appointing Party’s written notice use all reasonable efforts to agree who is to be appointed as the Expert to determine the relevant matter(s). If the Parties are unable to agree upon the identity of the Expert within that timescale, the Expert shall be appointed by the President (for the time being) of the Licensing Executives Society Britain and Ireland upon written request of either Party.

 

3. Each Party will within [***] ([***]) days following appointment of the Expert, prepare and submit to the Expert and the other Party a detailed written statement setting out its position on the matter(s) in question and including any proposals which it may wish to make for settlement or resolution of the relevant matter.

 

4. Each Party will have [***] ([***]) days following receipt of the other Party’s written statement to respond in writing thereto. Any such response will be submitted to the other Party and the Expert.

 

5. The Expert will if he/ she deems appropriate be entitled to seek clarification from the Parties as to any of the statements or proposals made by either Party in their written statement or responses. Each Party will on request make available all information in its possession and shall give such assistance to the Expert as may be reasonably necessary to permit the Expert to make his/ her determination.

 

6. The Expert will issue his/ her decision on the matter(s) referred to him/ her in writing as soon as reasonably possible, but at latest within [***] ([***]) months following the date of his/ her appointment. The Expert’s decision shall (except in the case of manifest error) be final and binding on the Parties.

 

7. The Expert will at all times act as an independent and impartial expert and not as an arbitrator.

 

8. The Expert’s charges will be borne as he/ she determines in his written decision.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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SCHEDULE 3

DEFINITION OF TOBACCO INDUSTRY FUNDING (REVISED 2009)

FROM THE CANCER RESEARCH UK CODE OF PRACTICE ON TOBACCO INDUSTRY FUNDING TO UNIVERSITIES.

http://www.cancerresearchuk.org/science/funding/terms-conditions/funding-policies/policy-tobacco/

A tobacco company is defined for the purposes of this policy as one that:

 

    Derives over 5% of revenues from manufacturing tobacco products;

 

    Derives 15%+ of revenues from the manufacture of products necessary for the production of tobacco products;

 

    Derives 15% of revenues from the sale of tobacco products (and has 30 or more staff);

 

    Owns a tobacco company (the company owns 50% or more of a tobacco company);

 

    Is more than 50% owned by a company with tobacco involvement.

The following do not constitute tobacco industry funding for the purposes of this Code:

 

    legacies from tobacco industry investments (provided these are sold on immediately)

 

    funding from a trust or foundation no longer having any connection with the tobacco industry even though it may bear a name that (for historical reasons) has tobacco industry associations.

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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SCHEDULE 4

LIST OF COUNTRIES AND TERRITORIES FOR PATENTS

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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SCHEDULE 5

INITIAL DEVELOPMENT PLAN

[***]

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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EX-10.13

Exhibit 10.13

Confidential Treatment Requested by MeiraGTx Holdings plc

LICENCE AGREEMENT

between

UCL Business Plc

and

MeiraGTx UK II Limited

and

MeiraGTx Limited

Dated: 15 March 2018

Ref:

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

 

INDEX
1.    Definitions      2  
2.    Grant of Rights      7  
3.    Know-how and Confidential Information      10  
4.    Consideration      12  
5.    Commercialisation      17  
6.    Access to Medicines and Ethical Licensing      20  
7.    Compliance with Laws      21  
8.    Intellectual Property      22  
9.    Warranties and Liability      24  
10.    Duration and Termination      29  
11.    General      32  
Schedule 1 Licensed Technology    37  
Schedule 2 Appointment of Expert    38  
Schedule 3 Definition of Tobacco Industry Funding (Revised 2009)    39  
Schedule 4 Initial Development Plan    40  

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


Confidential Treatment Requested by MeiraGTx Holdings plc

 

THIS AGREEMENT is made                     15 March ,             2018

 

BETWEEN:

 

(1) UCL BUSINESS PLC, a company incorporated in England and Wales under company registration number 02776963 whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP (“UCLB”);

and

 

(2) MEIRAGTX UK II LIMITED, (FORMERLY ATHENA VISION LIMITED), a company incorporated in England and Wales with registered number 09348737 and having its registered office at 92 Britannia Walk, London, United Kingdom, N1 7NQ (the “Licensee”); and

 

(3) MEIRAGTX LIMITED (FORMERLY KADMON GENE THERAPY HOLDINGS LIMITED), a company incorporated in England and Wales with registered number 09501998 and having its registered office at 92 Britannia Walk, London, United Kingdom, N1 7NQ (“Meira”).

 

WHEREAS:

 

A. University College London (“UCL”), through the Principal Investigators, has developed certain technology and owns certain intellectual property rights relating to a gene therapy for [***], including the Patents, the Know-how and the Materials.

 

B. UCL has assigned to UCLB all of its right, title and interest in and to such property.

 

C. The Licensee wishes to acquire rights under the Patents and to use the Know-how and the Materials for the development and commercialisation of Licensed Products in the Field and in the Territory, all in accordance with the provisions of this Agreement.

 

D. The Licensee aims to develop and commercialize the Licensed Product in the Field and in the Territory.

 

E. Meira wishes to issue shares in the capital of Meira in consideration for the grant of rights set out in this Agreement and is a party to this Agreement solely for this purpose.

 

F. It is the policy of UCLB that its activities in licensing intellectual property take into consideration ethical and socially responsible licensing principles, including ensuring that Licensed Products are made available to fulfil unmet needs in Developing Countries, and the Licensee acknowledges and agrees to carry out its activities under this Agreement in a manner which complies with ethical and socially responsible licensing principles and which is designed to fulfil such needs, all in accordance with the provisions of this Agreement.

 

NOW IT IS AGREED as follows:

 

1. DEFINITIONS

 

1.1 In this Agreement:

Agreement means this agreement (including the Schedules);

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Affiliate in relation to a Party, means any entity or person that Controls, is Controlled by, or is under common Control with that Party;

At-Cost Markets means those markets in Developing Countries [***];

Claims means all demands, claims and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, costs and expenses of any nature whatsoever and all costs and expenses (including legal costs) incurred in connection therewith;

Commencement Date means the date of this Agreement;

Commercial Third Party means a commercial entity that is not a Party of this Agreement;

Competing Product means any product, whether ready for marketing or in development that competes, or is likely to compete once developed, with any Licensed Product;

Confidential Information means the Know-how, the Materials and all other technical or commercial information that:

 

  a) in respect of information provided in documentary form or by way of a model or in other tangible form, at the time of provision is marked or otherwise designated to show expressly that it is imparted in confidence or which a reasonable person would expect to be confidential; and

 

  b) in respect of information that is imparted orally, any information that the Disclosing Party or its representatives informed the Receiving Party at the time of disclosure or which a reasonable person would expect to be confidential;

Consideration Shares means the Convertible Preferred C Shares of £0.00001 each in the capital of Meira to be allotted and issued to UCLB in accordance with Clause 4.1.2(a).

Control means direct or indirect beneficial ownership of 50% (or, outside a Party’s home territory, such lesser percentage as is the maximum permitted level of foreign investment) or more of the share capital, stock or other participating interest carrying the right to vote or to distribution of profits of that Party, as the case may be;

Cost-Based Price means, in respect of each Licensed Product, [***];

Developing Country or Developing Countries refers to those countries that are:

 

  a) [***]; and

 

  b) to the extent not included in a);

 

  i) defined as of the Commencement Date [***]; and

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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  ii) all other countries that may be mutually agreed to by UCL and Licensee from time to time;

Developing Country Manufacturer means a manufacturer of pharmaceutical products that is able to efficiently manufacture (either within or outside the Developing Country in which the At-Cost market exists), distribute and supply the Licensed Product in an At-Cost market at a Cost-Based Price;

Diligent Efforts means exerting such efforts and employing such resources as would normally be exerted or employed by [***], when utilizing sound and reasonable scientific, medical and business practice and judgment in order to develop the product in a timely manner and generate an economic return to the Parties from its commercialisation;

Disclosing Party has the meaning given in Clause 3.3;

Field means ocular gene therapy;

First Commercial Sale means the first sale to a third party of a Licensed Product in a given regulatory jurisdiction after all regulatory and marketing approvals have been obtained for such Licensed Product in such jurisdiction. A sale shall not be deemed to have occurred if a Licensed Product is provided pursuant to an early access or compassionate use;

Indemnitees has the meaning given in Clause 9.7;

Intellectual Property means any and all patents, utility models, registered designs, unregistered design rights, copyright, database rights, rights in respect of confidential information, rights under data exclusivity laws, rights under orphan drug laws, rights under unfair competition laws, property rights in biological or chemical materials, extension of the terms of any such rights (including supplementary protection certificates), applications for and the right to apply any of the foregoing registered property and rights, and similar or analogous rights in any part of the Territory;

Know-how means:

 

  a) the inventions claimed in the Patents; and

 

  b) the technical information relating to the inventions claimed in the Patents and data described in the Part B of Schedule 1;

Licensed Products means any and all products that are developed, manufactured, used, or sold by or on behalf of the Licensee or its Affiliates or Sub-licensees and which (a) are within (or are manufactured using a process described in) any claim of the Patents; and/or (b) incorporate, or their development or manufacture makes use of, any of the Know-how and/or the Materials;

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Licensed Technology means the Patents, the Know-how and the Materials set out in Schedule 1;

Materials means any and all of the materials referred to in Part C of Schedule 1;

Net Sales Value means in respect of the Licensed Products after their First Commercial Sale:

 

  a) the gross invoiced price of Licensed Products sold by the Licensee or its Affiliates or Sub-licensees in arm’s length sales of Licensed Products for cash consideration; and/ or

 

  b) where the sale is not at arm’s length and/ or is for or includes a non-cash consideration, or if Licensed Products used or subject to Clause 5.9, disposed of for free by the Licensee or its Affiliates the relevant open market price for the Licensed Product in the country or territory in which the sale, use or disposal takes place or if the relevant open market price is not ascertainable, a reasonable price, assessed on an arm’s length basis therefor,

after deduction of all documented:

 

  i) normal trade discounts (but excluding early payment discounts) actually granted and any credits actually given for rejected or returned Licensed Products;

 

  ii) costs of packaging, insurance, carriage and freight, provided in each case that the amounts are separately charged to the purchaser on the relevant invoice;

 

  iii) deductions for actual bad debt in connection with sales of Licensed Product (provided that Licensee will use Diligent Efforts to obtain payment of such bad debt);

 

  iv) value added tax or other sales tax; and

 

  v) import duties or similar applicable government levies charged to the purchaser on the relevant invoice.

provided that such deductions do not exceed reasonable and customary amounts in the markets in which such sales occurred. Sales of Licensed Products between the Licensee and its Affiliates shall not be taken into account for the purposes of calculating “Net Sales Value” unless there is no subsequent sale to a third party in an arm’s length transaction for a cash consideration;

Parties means UCLB, the Licensee and Meira, and “Party” shall mean either of them;

Patent Costs means [***].

 

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

 

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Patents means any and all of the patents and patent applications referred to in Part A of Schedule 1;