Master Alliance Provisions Guide (MAPGuide)

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

  • Equitable Access | Access plans & principles

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 […].

Global Access” means that (a) knowledge gained using the Foundation’s funding is promptly and broadly disseminated and (b) the products and technologies developed or supported with the Foundation’s funding will be made available and accessible at an affordable price to people most in need in Developing Countries.

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.

2. Charitable Purposes and Use of Funds

(a) The Foundation is making the Foundation Investment as a “program-related investment” within the meaning of Section 4944(c) of the Code. The Foundation’s primary purpose in making the Foundation Investment is to further significantly the accomplishment of the Foundation’s charitable purposes, including the relief of the poor, distressed, and underprivileged, the advancement of science, and the promotion of health by seeking to secure Global Access to new, low-cost drugs (both therapeutics and prophylactics) developed (in whole or in part) by the Company and directed at pathogens that disproportionately affect people in Developing Countries (collectively, the “Charitable Purpose”). In furtherance of the Charitable Purpose, the Foundation Investment will secure the Global Access Commitments described below.

(b) The proceeds from the Foundation Investment will be used solely to support the Company’s Staphylococcus aureus (S. aureus) antibody development program, including the Neonatal S. aureus Sepsis Discovery Project described below. […]

3. Global Access Commitments

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

(a) Neonatal S. aureus Sepsis Discovery Project. The Company will diligently conduct the Neonatal S. aureus Sepsis Discovery Project. “Neonatal S. aureus Sepsis Discovery Project” means the Company’s research, development, and use of the Platform Technology to generate and test in pre-clinical animal studies a candidate product for the prevention of neonatal sepsis caused by S. aureus and excluding all other therapeutic and prophylactic indications (such candidate product, the “ Neonatal S. aureus Sepsis Candidate ”) in accordance with the TPP and SOW attached as Appendix 2.

(b) Neonatal S. aureus Sepsis Candidate Development Program. Once the Neonatal S. aureus Sepsis Discovery Project is complete in accordance with the SOW, the Foundation will have the right, at its discretion, to continue providing funding to the Company (directly or through a Foundation-supported Entity) to advance the Neonatal S. aureus Sepsis Candidate through launch of a final product for the prevention of neonatal sepsis caused by S. aureus and excluding all other therapeutic and prophylactic indications (the “Neonatal S. aureus Sepsis Candidate Development Program”). The Neonatal S. aureus Sepsis Candidate Development Program may include applicable research, development, launch and associated activities conducted by the Company or a partner, if and to the extent these activities are reasonably requested by the Foundation. If requested by the Foundation, the Neonatal S. aureus Sepsis Candidate Development Program would be co-funded by additional equity investments (subject to requisite approval by the Company’s board of directors and/or stockholders) or grants from the Foundation pursuant to the Foundation’s standard grant making terms and processes. The specific level and allocation of funding responsibilities between the parties (and potentially Foundation-supported Entities) for the Neonatal S. aureus Sepsis Candidate Development Program will be mutually agreed in good faith in writing by the parties to fairly allocate the expected benefits between Developing Countries and developed countries; provided, that in no event will the funding responsibilities be allocated in a manner that is reasonably likely to result in a material adverse effect on the Company’s business or operations. Any agreements for the Neonatal S. aureus Sepsis Candidate Development Program will include a proposal describing the relevant work (including specific global access commitments) and other related documents acceptable to the Foundation, and will include a mutually-agreed upon TPP and SOW.

(c) Neonatal Sepsis Cocktail Development Program.

(i) The Foundation will also have the right, at its discretion, to provide funding to the Company (directly or through a Foundation-supported Entity) to develop a combination mAb product for use in the Foundation Field (such combination mAb product, the “Neonatal Sepsis Cocktail”), which Neonatal Sepsis Cocktail may include the Neonatal S. aureus Sepsis Candidate, mAbs developed under Discovery Projects (defined below), and/or components in-licensed from other entities in accordance with the terms below (the “Neonatal Sepsis Cocktail Development Program”). The Neonatal Sepsis Cocktail Development Program may include applicable research, development, launch and associated activities conducted by the Company or a partner, if and to the extent these activities are reasonably requested by the Foundation. If requested by the Foundation, the Neonatal Sepsis Cocktail Development Program would be co-funded by additional equity investments (subject to requisite approval by the Company’s board of directors and/or stockholders) or grants from the Foundation pursuant to the Foundation’s standard grant making terms and processes. The specific level and allocation of funding responsibilities between the parties (and potentially Foundation-supported Entities) for the Neonatal Sepsis Cocktail Development Program will be mutually agreed in good faith in writing by the parties to fairly allocate the expected benefits between Developing Countries and developed countries; provided, that in no event will the funding responsibilities be allocated in a manner that is reasonably likely to result in a material adverse effect on the Company’s business or operations.

(ii) Other than the Neonatal S. aureus Sepsis Candidate and mAbs developed under Discovery Projects, no mAbs developed by the Company independently from any collaboration with the Foundation (including in collaboration with any third-party) (“Company Developed mAbs”) will be included in the Neonatal Sepsis Cocktail unless mutually-agreed upon by the Company and the Foundation under separate agreements, for which reasonable financial and other terms will be negotiated in good faith by the Foundation and the Company taking into account principles of Global Access.

(iii) Any grant agreements for the Neonatal Sepsis Cocktail Development Program will include a proposal describing the relevant work (including specific global access commitments) and other related documents acceptable to the Foundation (and, in the case of any Company Developed mAbs, mutually acceptable to the Foundation and the Company), and will include a mutually- agreed upon TPP and SOW.

(d) Discovery Projects.

(i) The Company will also utilize the Platform Technology to conduct up to two Discovery Projects at the Foundation’s reasonable discretion and subject to the terms below. “Discovery Project” means a project proposed by the Foundation or a Foundation-supported Entity and conducted by the Company utilizing the Platform Technology to identify mAb candidates against a target pathogen or antigens associated with a target pathogen, in accordance with a mutually-agreed upon SOW and TPP, and potentially to further develop such candidates.

(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.

(iii) If the Foundation requests that the Company continue development of a candidate identified through a Discovery Project, the Company will consider in good faith and the parties will negotiate in good faith the terms of the applicable grant documents for such work. To the extent the parties agree to continue support of a Discovery Project beyond the discovery phase, the specific level and allocation of additional funding responsibilities for such Discovery Project will be mutually agreed in good faith in writing by the parties based on a fair allocation of the expected benefits between Developing Countries and developed countries, provided that in no event will the funding responsibilities be allocated in a manner that is reasonably likely to result in a material adverse effect on the Company’s business or operations.

(e) Third Party Manufacturers. If the Foundation determines, in consultation with the Progress Review Group, during the Neonatal S. aureus Sepsis Candidate Development Program, Neonatal Sepsis Cocktail Development Program, or any Discovery Project that working with a third-party manufacturer (“TPM”) is reasonably necessary to achieve the price and volume commitments described below, the Company will agree to license and transfer the necessary technology and other intellectual property to such TPM (subject to such TPM entering into reasonable agreements with the Company with respect to confidentiality and use of the technology and licenses solely for the purposes contemplated herein) in order to allow the production of Products for the Developing Countries. The Foundation will be responsible for the reasonable costs payable for the license and technology transfer of the necessary intellectual property to such TPM.

(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 ”).

(ii) If the Foundation intends to make a Third Party Development Program Election, it will give the Company prompt written notice thereof. If the Company disagrees with the Foundation’s determination to make a Third Party Development Program Election, the parties will engage in good faith discussions and negotiations for a period of [**] days from the date of the Foundation’s written notice in an attempt to resolve such disagreement, and the Foundation will not be entitled to make a Third Party Development Program Election during such [**]-day period. Following such [**]-day period, the Foundation will be entitled to make a Third Party Development Program Election by delivery of written notice to the Company thereof.

(iii) The license described in this Section 3(f) will be subject to payment by the Foundation or a Foundation sublicensee of the applicable royalty (if any) set forth in and calculated under 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 this license. In addition, if the Foundation exercises its rights under the license pursuant to a Third Party Development Program Election, the parties will negotiate in good faith the payment of a reasonable royalty to the Company on sales of the applicable Product outside of the Developing Countries.

(g) Licenses to Company. The Foundation Investment will be conditioned on the Company’s receipt and continuation of all necessary licenses and rights with respect to the Platform Technology needed to perform the Global Access Commitments. To the extent that a license to a mAb or other component is necessary for the development, manufacture, or commercialization of a Product (other than with respect to the Platform Technology), which component would be impracticable for the Company to develop, the Company will use Reasonable Efforts to obtain a cost effective and affordable license to such component from a third party and/or to collaborate with a third party to develop or manufacture such component, in order to enable completion of the applicable product in accordance with the Global Access Commitments, including the price and volume commitments. The Foundation will be responsible for the costs payable to the third party for the license or collaboration to the extent necessary for this product in Developing Countries; provided, that the Foundation consents in writing to the terms of the applicable license or collaboration agreement before the execution of the agreement and the terms allow the Company to transfer or sublicense any license to the Foundation or a Foundation supported Entity in the event of a Trigger Event.

(h) Pricing and Volume Commitments. The Company will work with the Foundation to develop (by the time of completion of Phase II clinical trials) and execute a manufacturing and supply plan that will enable to be met the reasonably expected demand in Developing Countries for any Products. The expected demand will be determined by the Foundation and the Company based upon review of the Foundation’s target markets for the applicable product and other relevant considerations, including cost- effectiveness. The price of the relevant Products in Developing Countries will be such that the Products are affordable to low income individuals in the Developing Countries, and in no case would the price charged by the Company to the relevant procurer or distributor of such products exceed Actual Production Costs plus [**]%. For clarity, the Company will in no event be required to offer the applicable Product to a procurer or distributor at a price that would be less than Actual Production Costs. The manufacturing and supply plan could involve the use of manufacturing partners and support from donors, and the specific level and allocation of funding responsibilities in such plan will be decided as mutually agreed in good faith in writing by the parties based on a fair allocation of the expected benefits between Developing Countries and developed countries. The Foundation will have the right to inspect the Company’s records to verify the Actual Production Costs. These commitments do not apply to sales of Products used outside of the Developing Countries.

(i) Progress Review Group. The Company and the Foundation will each designate up to [**] individuals to be part of a progress review group (the “Progress Review Group”) that will provide a forum for discussion of the progress of the Company’s S. aureus antibody development program (including antibodies being developed for use in developed countries) and the Funded Developments. The Progress Review Group will meet via teleconference at least [**] (unless both parties agree that any [**]meeting will be conducted via teleconference). With the agreement of both parties and subject to the execution of appropriate confidentiality agreements, third parties may be invited from time to time to participate in certain Progress Review Group discussions.

(j) Publication; Access to Data and Information. The Company (in addition to the publication requirements of any applicable grants from the Foundation):

(i) will publish the results and information developed in connection with each Program within a reasonable period of time after such information or results are obtained, subject to reasonable delays or limitations on content of such publications that are necessary to protect intellectual property and trade secrets or other proprietary know-how covering the Platform Technology itself and subject to third party confidentiality obligations;

(ii) will promptly provide to the Foundation from time to time, upon the Foundation’s reasonable request and subject to customary confidentiality restrictions, access to data and information regarding the Company’s S. aureus antibody development programs (including raw data and regarding antibodies being developed for use in developed countries and for any indication, subject to the Foundation agreeing to appropriate confidentiality obligations) and each Program, and the reasonably contemplated use of the Platform Technology for such programs; and

(iii) will promptly provide to the Foundation from time to time, upon the Foundation’s request, rights to share such non-public data and information regarding each Program, and the reasonably contemplated use of the Platform Technology for such Programs, subject to the reasonable need to protect confidential information (including, in the event that the Foundation proposes to share any such data or information with any Direct Competitor, such disclosure to a Direct Competitor shall be permitted only to the extent that the Foundation or a Foundation-supported Entity is collaborating with such competitor, and limited to the disclosure of data or information directly relating to the development, production or commercialization of a Product, as applicable to such collaboration) and to avoid untimely public disclosures that may bar access to patent protection or public disclosures that may undermine trade secret protection or may impact the market competitiveness of a Company product.

All publications must be made in accordance with “open access” terms and conditions consistent with the Foundation’s Open Access Policy available at: http://www.gatesfoundation.org/How- We-Work/General-Information/Open-Access-Policy, which may be modified from time to time. If any publication or presentation contains Adimab Confidential Information, the Company may submit such publication or presentation for prior review and approval by Adimab for patentability and protection of Adimab Confidential Information as provided in Section 6.8 (and subject to Section 6.2) of the Adimab Agreement. The Company may not proceed with such publications or presentations containing Adimab Confidential Information unless approved of in advance in writing by Adimab in accordance with Section 6.8 of the Adimab Agreement. The Company will use reasonable efforts to obtain such approval. The Company will provide to Adimab the opportunity to review, in accordance with Section 6.8 of the Adimab Agreement, any proposed abstracts, manuscripts or summaries of public presentations that contain Adimab Confidential Information.

(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).

(n) Sufficient Rights; Inventory

(i) The Company represents and warrants that: (A) the Company owns or possesses, or believes it can acquire on commercially reasonable terms, all necessary rights required in order to perform its obligations and grant the licenses hereunder, (B) Arsanis mAbs ASN-1, ASN-2, and ASN-3 are included in the Optioned Antibodies and ASN-1 and ASN-2 are the mAbs that comprise the ASN100 Product Candidate, and (C) each of the Option Exercise Letters was delivered to and acknowledged by Adimab during the relevant Option Term (as defined in the Adimab Agreement) applicable to each of the Optioned Antibodies.

(ii) The Company represents and warrants that, as of the Effective Date, it has in inventory or has a contractual right to obtain a sufficient amount of the ASN100 Product Candidate and placebo therefor to timely complete the presently ongoing Phase II clinical study of the ASN100 Product Candidate.

(o) The Arsanis mAbs ASN-1, ASN-2, and ASN-3 are considered Program-Benefitted Antibodies (as defined in the Adimab Agreement) under the Adimab Agreement and (B) the Foundation Investment is a Program Transaction (as defined in the Adimab Agreement) under the Adimab Agreement.

(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.

(q) Duration of Global Access Commitments. The Global Access Commitments will be ongoing and will continue for as long as the Foundation exists, except that (i) the Company’s obligation to accept Discovery Projects will terminate five years following the closing of the Foundation Investment (such five-year period will be extended to accommodate initiation of any Discovery Projects that may be under discussion by the Parties at the end of such period) and (ii) the Global Access Commitments shall expire in relation to a Program at such time as the Foundation or a Foundation-supported Entity has not, during the previous seven-year period, provided funding to the Company in furtherance of such Program; provided that, if a product developed (in whole or in part) with Foundation funding continues to be developed or available in Developing Countries, the Global Access Commitments will be ongoing and will continue with respect to such product.

(r) Confidentiality. The confidentiality obligations set forth in the Nondisclosure Agreement between the Foundation and the Company dated of even date herewith shall be incorporated herein by reference.