Master Alliance Provisions Guide (MAPGuide)

Gates Foundation – Arsanis, S. Aureus Antibody Strategic Relationship Letter Agreement

  • Equitable Access | Ensuring continuity
  • Intellectual Property | License Grants

Definitions

Developing Countries” means the [list of countries in Appendix 1], which includes (i) countries eligible for GAVI support as of 2016, (ii) countries in the process of transitioning out of GAVI support in 2016, and (iii) Botswana, Brazil, Philippines, South Africa and Thailand. “Developing Countries” also means any countries reasonably requested by the Foundation that are part of the Foundation’s strategies to which the Company consents in writing, such consent not to be unreasonably withheld […].

Funded Developments” means the products, technologies, materials, processes, and other intellectual property and intellectual property rights developed using funds from the Foundation or a Foundation-supported Entity or developed in connection with the Company’s conduct of a Program.

Platform Technology” means the Company’s mAb research, discovery, development, and production capabilities, including those sourced from its partners. For clarity, Platform Technology includes technologies, materials, know-how and intellectual property owned, controlled, or in licensed by the Company or its Affiliates, whether existing at closing of the Foundation Investment or later developed, owned, controlled or in licensed by the Company or its Affiliates.

Program” means the Neonatal S. aureus Sepsis Discovery Project, the Neonatal S. aureus Sepsis Candidate Development Program, the Neonatal Sepsis Cocktail Development Program and any Discovery Project.

3. Global Access Commitments

In furtherance of the Charitable Purpose and Global Access, the Company agrees to the following (collectively “Global Access Commitments”):

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(d) Discovery Projects

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(ii) Each Discovery Project will be funded and conducted pursuant to the Foundation’s standard grant making terms and processes, which would include a proposal prepared in good faith by the Company (which will be submitted within [**] days after the Foundation’s initial request to the Company) describing the relevant work to be conducted by the Company and other related documents acceptable to the Foundation. At the request of the Foundation, such grant agreements will include a non-exclusive license to resulting product candidates and related technology resulting from the applicable Discovery Project (including the right to sublicense or a direct license grant to Foundation supported Entities); provided, that the scope of the license to the related technology will include only that technology that is necessary for the development, production or distribution or sale of the relevant product candidate within the field of use prescribed for such product candidate in the applicable TPP. Notwithstanding the foregoing, except as otherwise provided below, the Foundation will not practice the license for sale or distribution of any product candidate outside of the Developing Countries unless the Company or a licensee thereof commits a material breach of any of the Global Access Commitments in regard to such product candidate. For clarity, the Company agrees that this license may be practiced outside of Developing Countries (other than to sell, have sold, offer for sale or otherwise transfer to an end user of such product or product candidate) solely for activities that are in furtherance of the sale or other distribution of product candidates in Developing Countries.

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(f) Licenses from Company

(i) At the request of the Foundation, the grant or funding agreements for the Neonatal S. aureus Sepsis Candidate Development Program and Neonatal Sepsis Cocktail Development Program will also include a non-exclusive license to (i) the Neonatal S. aureus Sepsis Candidate and (ii) candidates or products developed under the Neonatal S. aureus Sepsis Candidate Development Program or Neonatal Sepsis Cocktail Development Program, for use in the Foundation Field, in each case with related technology (including the right to sublicense or a direct license grant to Foundation-supported Entities); provided that the scope of the license to the related technology will include only that technology that is necessary for the development, production and/or distribution or sale of the relevant product. For the avoidance of doubt, the Foundation, Foundation supported Entities, and Foundation sublicensees will not directly or indirectly develop or commercialize the Neonatal S. aureus Sepsis Candidate or products developed under the Neonatal S. aureus Sepsis Candidate Development Program or Neonatal Sepsis Cocktail Development Program outside of the Foundation Field. The license will be presently granted, but the Foundation may not exercise its rights (including its sublicense rights) under the license to any background intellectual property of the Company unless at least one of the following occurs:

(A) any Trigger Event;

(B) the Company commits a material breach of the relevant grant agreement that is not cured within [**] days after written notice thereof;

(C) the Company is unwilling to unable or ceases to promptly conduct or complete in any material respect the Neonatal S. aureus Sepsis Candidate Development Program or Neonatal Sepsis Cocktail Development Program, as applicable; or

(D) the Foundation (after discussion with the Progress Review Group) reasonably determines that the Company does not have the personnel, capability, technology, rights or other resources to conduct or complete the Global Access Commitments in connection with the Neonatal S. aureus Sepsis Candidate Development Program or Neonatal Sepsis Cocktail Development Program in any material respect, including the price and volume commitments described below (any exercise of such license pursuant to this clause (i)(D), a “Third Party Development Program Election”).

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(k) No Inconsistent Rights. The Company will not grant to a third party any rights or enter into any arrangements or agreements that would limit or restrict the Foundation’s rights to the Global Access Commitments.

(l) Global Health License

(i) Global Health License. Subject to Section 3(ii), in connection with and relating to each Program, and to the extent not already licensed to the Foundation hereunder, the Company hereby grants the Foundation and/or Foundation-supported Entities, a worldwide, nonexclusive, non-terminable, perpetual, irrevocable, royalty-free (except as specified below) license (with the right to sublicense) to the (A) Funded Developments and (B) and the background intellectual property of the Company that is necessary for or is used in the Platform Technology or Programs to use, reproduce, modify, make, distribute, sell, offer-for-sale, import, and otherwise dispose of products and services directed at pathogens or other targets subject to the Programs, which license is limited, in relation to each Product or Program with respect to which it is practiced by the Foundation, to the field of use set forth in the agreement(s) applicable to such Product or Program (the “Global Health License”). The Global Health License will be subject to payment by the Foundation or a Foundation sublicensee of the applicable royalty (if any) set forth in and calculated in accordance with the Adimab Agreement as of the Effective Date (payable to Adimab, either through Company or, at Company’s election, directly to Adimab), to the extent such royalty is then payable to Adimab under the Adimab Agreement, as a result of the exercise of Global Health License.

(ii) Trigger Events. The Global Health License is presently granted and effective. However, the Foundation will not practice its rights under the Global Health License (including its sublicensing rights) unless a Trigger Event occurs and then only with respect to the Product or Program affected by the Trigger Event. Accordingly, if a Trigger Event applies only to a particular Product or Program, the Foundation will have the right to exercise the Global Health License only for such Product or Program. “Trigger Event” means:

(A) a Charitability Default; or

(B) the Company (i) institutes any bankruptcy, insolvency, appointment of a receiver and/or trustee or reorganization (in either case for the release of financially distressed debtors), general assignment for the benefit of creditors, winding-up, dissolution, liquidation or similar proceeding relating to it under the laws of any jurisdiction or any such proceeding is instituted against the Company which remains undismissed or unstayed for a period of 90 days or (ii) ceases to conduct business in the ordinary course.

If either the Foundation or the Company becomes aware of a Trigger Event it will promptly notify the other party in writing of the occurrence of such Trigger Event.

(m) Cooperation; Technology Transfer. In connection with the exercise of any license hereunder or under a grant agreement (as applicable), the Company will take further actions, including technology transfer (subject to the transferee agreeing to appropriate confidentiality obligations), as would be commercially reasonable industry practice at the time with respect to providing a biotechnology license to a third party, to accommodate that the Foundation, the Foundation’s sublicensees, and/or the relevant Foundation supported Entity can effectively exercise the applicable license or sublicense and use the related technology (including the right to reference regulatory filings related to the  applicable products).

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(p) Adimab Agreement. The Foundation agrees that, if the Foundation or any Foundation-supported Entity grants a sublicense to a third party under any license granted hereunder by the Company to any rights covered by the Adimab Agreement, then the sublicense agreement will be made in a manner that is consistent with and subject to the applicable terms of the Adimab Agreement to the extent required by Section 3.3 of the Adimab Agreement. Prior to entering into any such sublicense to conduct activities in furtherance of the development, research, sale, distribution or other disposition of Products for the benefit of people outside of the Developing Countries, the Foundation shall provide a copy of the sublicense agreement to the Company and the Foundation shall incorporate comments from the Company as necessary to ensure compliance with the Adimab Agreement through multiple tiers. The Company must provide comments within [**] business days and will be deemed to have no comments if such comments are not provided within such [**] business-day period. Without limiting the foregoing, any such sublicense will provide the Foundation with the right to terminate the sublicensee’s rights to any rights covered by the Adimab Agreement or this Agreement granted under the sublicense for uncured material breach of the sublicense agreement as it pertains to those rights. To the extent the sublicense includes rights other than rights covered by the Adimab Agreement or this Agreement, such termination will not apply to such other rights and neither Adimab nor the Company will be entitled to enforce any termination of such rights. In addition, the sublicense agreement will state that both Adimab and the Company are intended third party beneficiaries of the relevant terms of the sublicense agreement that affect or relate to any rights or obligations of the Company under this Agreement or the Company or Adimab under the Adimab Agreement, as the case may be, including with respect to indemnification, with the right to enforce those terms, including the right to enforce the termination of the sublicense. With respect to a sublicense to conduct activities in furtherance of the development, research, sale, distribution or other disposition of Products for the Developing Countries, notwithstanding anything in the Adimab Agreement to the contrary, the sublicense agreement will not (i) restrict or limit the identity or form of the sublicensee, (ii) impose royalty or financial obligations (other than the [**]% royalty specified in the Adimab Agreement as of the Effective Date of this Letter Agreement), (iii) restrict or limit the Foundation Field or place additional restrictions on the scope of the rights granted under any of the licenses as described in this Letter Agreement, or (iv) require the sublicensee to grant intellectual property rights or licenses to Adimab or the Company (except with respect to improvements to the Adimab platform intellectual property). Within [**] days after executing a sublicense agreement, the Foundation will provide a copy of the relevant terms of the sublicense agreement to the Company with the right to disclose to Adimab. Except with respect to the sublicenses for the benefit of people outside the Developing Countries as described above in this Section 3(p), the Company will have the right to review but not to approve of the relevant terms of the sublicense agreement. The Company will promptly notify the Foundation in writing of any concerns regarding the terms of the sublicense agreement. Under no circumstances will the Foundation be responsible for the acts or omissions of any sublicensee of any tier, including for breach of the sublicense agreement or otherwise. For clarity, the Foundation does not and will not indemnify nor defend Adimab or the Company for acts or omissions of sublicensees of any tier, but shall ensure that any sublicense agreement includes the indemnification obligations on terms set forth in the Adimab Agreement and for the benefit of both the Company and Adimab and to which the Company and Adimab are third party beneficiaries. For clarity, neither Adimab nor the Company will have the right to audit the records of the Foundation but shall ensure that any sublicense agreement includes the audit provisions on terms set forth in the Adimab Agreement and for the benefit of both the Company and Adimab and to which the Company and Adimab are third party beneficiaries. At the request of the Foundation, the Company will use good faith and reasonable efforts to work with the Foundation to help ensure that the sublicenses can be used for the achievement of the Charitable Purpose without undue restrictions. These efforts include using good faith and reasonable efforts to promptly request and obtain waivers or consents from Adimab.