Provision Language
Definitions
“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.
2. Charitable Purpose; Use of Proceeds.
(a) Charitable Purpose. The Foundation is making the Foundation Investment as a “program-related investment” within the meaning of Section 4944(c) of the Code. The Foundation is committed to accelerating the development of lifesaving and low-cost drugs, therapeutics, diagnostics, and prophylactics to reduce the burden of disease in developing countries in furtherance of its mission to help all people lead healthy, productive lives. The Foundation’s primary purpose in making the Foundation Investment is to secure Global Access to new, low-cost products and services developed through the use of the Company’s proprietary capabilities and intellectual property all as contemplated herein, including (i) research capabilities across all of the Company’s Platform Technology which are specifically utilized in the HIV Project, TB Project and/or in one or more Additional Projects, (ii) Foundation-supported product candidates related to the Foundation’s target diseases for use in the developing world and (iii) product development capabilities (collectively, the “Charitable Purpose”). In furtherance of the Charitable Purpose, the Foundation Investment will secure the Global Access Commitments described below.
(b) Use of Proceeds. The proceeds from the Foundation Investment will be used solely in furtherance of the Charitable Purpose to:
(i) officially establish and build the infectious disease capabilities of the Company in accordance with Section 3(i) with a budget of EUR 16.15 million, including costs for new FTEs, infrastructure (labs and facilities) and further developing the technology platforms (including taking further licenses to technology) to enable the Company to complete the Projects;
(ii) conduct the Initial HIV SOW; and
(iii) conduct the Initial TB SOW.
The proceeds from the Foundation Investment will not be required to be segregated in a separate account.
3. Global Access Commitments
As a condition to the Foundation making the Foundation Investment and to ensure satisfaction of the Charitable Purpose and Global Access, the Company agrees to the following (collectively “Global Access Commitments”):
(a) Performance of Initial Scopes of Work
(i) The Company will use the Foundation Investment to complete the work packages set forth in the Initial HIV SOW and the Initial TB Project SOW. In the event that during the course of performing the Initial HIV SOW and the Initial TB SOW the Company determines that the costs are reasonably likely to exceed the aggregate agreed budget for such Projects of [***] and the Company has used good faith efforts to adhere to the agreed budget and the parties have not materially modified the Initial HIV SOW or the Initial TB SOW, the Company will provide estimates for the additional costs and the reasons for the proposed additional costs to the Joint Steering Committee. The Joint Steering Committee will determine whether additional costs are necessary and the amount of such costs. The Company and the Foundation will determine in good faith a reasonable allocation of such additional costs between the Company and the Foundation or Foundation-supported Entities. If [***], as applicable.
(ii) If the parties mutually agree to make any material modifications to the Initial HIV SOW or the Initial TB SOW that impact the budget for such Projects, then at the time of such modification the parties will agree upon the new budget, and the [***] described in subsection (i) above will be based on the adjusted budget.
(iii) After the Company has completed the Initial HIV SOW and/or the Initial TB SOW, the Foundation will have the right, at its discretion (subject to the Company’s right to decline any additional funding to the extent permitted by Section 3(d)(v) below), to continue providing funding (directly or through a Foundation-supported Entity) to advance the HIV Project and/ or TB Project through commercialization and distribution of a final product in accordance with the HIV TPP, TB POI TPP and/or TB POD TPP, as applicable, in accordance with Section 3(d) below. Depending upon the achievement of Project progress-driven milestones, which may be defined in the respective Project statements of work, the parties currently anticipate that the total potential grant funding relating to Projects (including Projects funded by Foundation-supported Entities) could reach up to forty five million dollars (USD$45,000,000.00), provided that any such additional grant funding will be in the Foundation’s discretion and subject to execution of grant documents for such Projects in accordance with the Foundation’s standard grant making process.
(b) Additional Projects. If requested by the Foundation, at its discretion, and subject to the terms herein, the Company will utilize the Platform Technology to diligently conduct up to three (3) Additional Projects (in addition to the HIV Project and TB Project). The Foundation, at its discretion, can select the Additional Projects from the list of diseases set forth on Part A of Appendix C. For the avoidance of doubt, the Additional Projects will not be funded by the Foundation Investment except in the limited circumstances following a determination that it is futile to continue with a workplan as set forth in the TB Project Statement of Work or HIV Project Statement of Work. If the Foundation elects to proceed with one or more Additional Projects, it will provide additional funding as described herein. The Company and the Foundation can work on more than three (3) Additional Projects in parallel if they mutually agree to do so. The Foundation will have five (5) years from the Closing of the Foundation Investment to identify Additional Projects. The initial scope of work (to be financed with additional funding from the Foundation except in the limited circumstances following a determination that it is futile to continue with a workplan as set forth in the TB Project Statement of Work or HIV Project Statement of Work) for all Additional Projects, regardless of the individual Project’s start date, will be structured in such a way that it is scheduled to be completed by the eighth (8th) anniversary of the Closing of the Foundation Investment (the “Completion Date”). Following the Completion Date, the Company will have the right to accept or decline any additional funding for any additional work under such Additional Projects as described in Section 3(d)(v) below, provided that the Global Access Commitments shall continue to apply with respect to the Funded Developments (and to the Platform Technology to the extent required to further develop and commercialize the Funded Developments in accordance with this Letter Agreement) developed to, or existing at the Completion Date. If the Foundation elects to proceed with all three (3) Additional Projects, at least one of such projects will be related to malaria.
(c) Performance of Projects. The Company will perform all Projects in good faith using substantially the same level of efforts, resources, time, and expediency as are consistent with the practices of the Company with respect to the research and development, regulatory approval and commercialization of any other Company products at a similar stage in development, including the Company’s commercial products intended for markets other than in Developing Countries.
(d) Further Development
(i) If the Foundation elects at any time to proceed either with additional work on the HIV Project, TB Project or any Additional Project, the Foundation and the Company will agree in good faith on one or more subsequent statements of work, which may include applicable development, commercialization and associated activities conducted by the Company and potentially one or more partner(s) that are not Direct Competitors as agreed by the Company and the Foundation, including seeking applicable country-level regulatory approvals. Such partner may include the Gates MRI if requested by the Foundation and agreed to by the Gates MRI and the Company.
(ii) If the Foundation requests the Company to continue work on the HIV Project, the TB Project and/or any Additional Project, any additional funding from the Foundation or a Foundation-supported Entity will be provided pursuant to the Foundation’s standard funding terms and processes. The specific level and allocation of funding responsibilities between the parties (and potentially Foundation-supported Entities) for any such Project will be mutually agreed in good faith in writing by the parties to fairly allocate the expected benefits between Developing Countries and developed countries.
(iii) Any agreements for further work relating to the HIV Project and/or TB Project or for an Additional Project will include a proposal describing the relevant work (including specific Global Access Commitments) and other related documents acceptable to the Foundation and the Company including a manufacturing, commercialization and distribution plan for the Developing Countries taking into account the Company’s actual and projected capabilities at the time of developing such plan, and will be consistent with the HIV TPP, the TB POI TPP, the TB POD TPP and/or any TPP relating to an Additional Project, as applicable. The applicable funding agreements will also include a mutually acceptable license to the Funded Developments developed or acquired (including in-licensed) by the Company in connection with the Company’s conduct of such work and the Platform Technology to the extent required to further develop and commercialize the relevant Product(s). The terms of such license will be no less favorable to the Foundation than the terms of the Global Health License, unless mutually agreed otherwise by the parties in their respective discretion.
(iv) If the Foundation desires to continue funding as set forth herein to advance the HIV Project, TB Project and/or any Additional Project through commercialization and distribution of a final product, but the Company reasonably believes that such further product development is not feasible due to scientific or technical failure or would cause a material adverse effect on the Company, then the matter will be submitted to the Joint Steering Committee. If the members of the Joint Steering Committee do not mutually agree with the Company’s determination then the matter will be resolved in accordance with the dispute resolution process set forth in Section 20 below.
(v) Notwithstanding the foregoing, the Company will have the right to decline any additional funding or extension of (1) the TB Project following completion of the Initial TB SOW and either the occurrence of an Event Stamp TB or in accordance with Section 3(d)(vi)(B), (2) the HIV Project following completion of the Initial HIV SOW and either the occurrence of an Event Stamp HIV or in accordance with Section 3(d)(vi)(B) and (3) any Additional Project following the Completion Date or in accordance with Section 3(d)(vi)(B). If the Foundation desires to continue funding the HIV Project, the TB Project and/or any Additional Project and the Company does not agree to accept such additional funding and continue development of the applicable Project to the extent permitted by (1), (2) or (3) above (each such case a “Company Election Not to Proceed”), then the commitments described in Sections 3(d)(v)(A) and 3(d)(v)(B) will apply.
(A) Further Development Activities Following a Company Election Not to Proceed
(1) If elected by the Foundation, and subject to the agreement of the Gates MRI, the Company will grant a license equivalent to the Global Health License to the Gates MRI and a license in accordance with Section 3(d)(v)(B)(3) to the Manufacturing Partner identified pursuant to the process set forth below and will undertake associated technology transfer activities to the extent reasonably required for the further development and manufacturing (if applicable) of the applicable Product pursuant to a development plan on reasonable market terms.
(2) If the Foundation does not make the election set forth in Section 3(d)(v)(A)(1) above, the Company will use reasonable best efforts to identify a third party that is reasonably acceptable to the Foundation to continue development of the applicable Product (which third party may also be the Manufacturing Partner identified below). If a third party is not selected to continue development of the applicable Product pursuant to the previous sentence, the Foundation will have the right to identify a third party that is not a Direct Competitor to continue development of the applicable Product (which third party may also be the Manufacturing Partner identified below). The Gates MRI or the third-party identified pursuant to this clause 3(d)(v)(A)(2) is referred to as the “Development Partner”.
(3) The Company will grant a license equivalent to the Global Health License to the Development Partner and, unless the Company is manufacturing all Product required by the Development Partner, a license in accordance with Section 3(d)(v)(B)(3) to the Manufacturing Partner identified pursuant to the process set forth below if the Development Partner is not also the Manufacturing Partner, and will undertake associated technology transfer activities to the extent reasonably required for the further development of the Product. In addition, [***]. The Company will notify the Foundation at least 10 days [***]. The Company may request from any Development Partner that (1) its name and/or logo must be appropriately displayed on any Product (or any related marketing materials, leaflets or packaging) that will be distributed by any Foundation-supported Entity (which may include the Development Partners, Manufacturing Partners or sublicensees) under this Letter Agreement and (2) the Development Partner adequately mentions the Company as the technology provider to the extent applicable in any public statements or disclosures relating to any Product.
(B) Further Manufacturing Activities Following a Company Election Not to Proceed:
(1) If requested by the Company, the Company shall have the right to manufacture all Product required by the Development Partner under a manufacturing agreement to be concluded between the Company and the Development Partner.
(2) If the Company does not request to manufacture the Product and the Development Partner identified above is unable or unwilling to manufacture the applicable Product, the Company will use reasonable best efforts to identify a third party that is reasonably acceptable to the Foundation to manufacture the Product, including considering in good faith potential manufacturers proposed by the Foundation. The third-party identified pursuant to this Section 3(d)(v)(B)(2) with whom the Development Partner has concluded an agreement with respect to the manufacture of the Product is referred to as the “Manufacturing Partner”.
(3) The Company will grant a non-exclusive license to the Manufacturing Partner to the extent required for the Manufacturing Partner to fulfill its manufacturing obligations related to the Product for the Development Partner for Developing Countries and will undertake associated technology transfer activities on reasonable market terms to the extent reasonably required for the manufacturing of the Product. If [***]. The Company may request from any Manufacturing Partner that (i) its name and/or logo must be appropriately displayed on any Product (or any related marketing materials, leaflets or packaging) manufactured by such Manufacturing Partner and (ii) the Manufacturing Partner adequately mentions the Company as the technology provider to the extent applicable in any public statements or disclosures relating to any Product.
(4) If a Manufacturing Partner is not identified pursuant to Section 3(d)(v)(B)(2) , the Company will manufacture the initial supply of the relevant Product required for the immediate planned clinical study and will continue to supply Product for subsequent trials until a Manufacturing Partner is identified. The Company will continue to apply reasonable best efforts to identify a Manufacturing Partner during this time.
(5) If a Manufacturing Partner is not identified by the Company within a reasonable time prior to market approval of the applicable Product, the Company will, provided it has a facility to provide commercial manufacturing quantities for the applicable Product, manufacture the commercial supply of the Product under a contract manufacturing agreement to be concluded on reasonable market terms between the Company and the Development Partner until a suitable Manufacturing Partner is identified. If the Company does not have an adequate commercial manufacturing capability to manufacture a sufficient quantity of the applicable Product and a Manufacturing Partner has not been identified, the Company will build such a facility (or increase the capacity of an existing facility) to meet the manufacturing, commercialization and distribution requirements agreed by the Foundation and the Company in good faith in the relevant grant proposal document for the relevant Product. The funding for such build will be mutually agreed in good faith in writing by the Foundation and the Company to fairly allocate the expected benefits between Developing Countries and developed countries. If at any time following the commencement of such build a Manufacturing Partner is identified, the Company may choose (in its sole discretion) to either (X) initiate or continue (as the case may be) the manufacturing or (Y) grant a manufacturing license to such Manufacturing Partner and to provide technology transfer activities on reasonable market terms to such Manufacturing Partner to the extent reasonably required for such manufacturing. For the avoidance of doubt, during the time that the Company is building a facility or increasing the capacity of an existing facility pursuant to this Section 3(d)(v)(B)(5) , it will not be required to reduce the commercial manufacturing output at its existing facilities in order to accommodate manufacturing additional Products beyond what it has already committed to manufacture.
(6) For clarity, the licenses granted pursuant to Sections 3(d)(v)(A) and 3(d)(v)(B) (and associated technology transfer obligations) will not be subject to any Exercise Events. These licenses and activities will be documented in agreements between the Company and the relevant party entered into as soon as reasonably possible. When a license is required to be granted under the terms stated above, the relevant parties may agree to a broader license but under no circumstance (except for the license granted pursuant to Section 3(d)(v)(B)(3) ) will the license be more restrictive than the Global Health License required under this Letter Agreement. All manufacturing and related activities to be performed by the Company under this Section 3(d)(v)(B) (including logistics, warehousing, transport, etc.) shall be charged by the Company at Fully Loaded Costs of the relevant Product (excluding, for the avoidance of doubt, the manufacturing for developed countries which have been licensed to the Development Partner).
(vi) Prior to [***], as applicable:
(A) If [***].
(B) If [***].
(vii) If at any time the Foundation does not elect to proceed with additional work on a Project or further development of a Product, including following a Foundation Election Not to Proceed, (A) the Global Access Commitments shall continue to apply with respect to the Funded Developments (and to the Platform Technology to the extent required to further develop and commercialize the Funded Developments in accordance with this Letter Agreement) developed to, or existing at the time the Foundation ceases to proceed with funding additional work or further development (but, for the avoidance of doubt, not with respect to any developments made by or on behalf of the Company after such point if the Company decides to continue the development outside of the scope of this Letter Agreement), (B) the Foundation will have the right at any time to elect to proceed with additional work on such Project or further development of such Product in accordance with this Section 3(d) and the Company will continue such development or, if the Company declines to continue such development as permitted in Section 3(d)(v), the commitments described in Sections 3(d)(v)(A) and 3(d)(v)(B) will apply and (C) the Company will not grant to a third-party any rights or enter into any arrangements or agreements or otherwise take any actions that would limit or restrict the Global Access Commitments with respect to the Funded Developments, including as described in subsections (A) and (B) above.
(e) Pandemic Response. If during the conduct of the HIV Project Statement of Work or TB Project Statement of Work there is a need for an emergency response to a pandemic of an infectious disease that has not already been partnered with a third party [***], the Foundation can request the Company to accept a grant-funded project in response to such pandemic, and the Company may elect to accept such funding at its sole discretion, which may include the development of a drug, vaccine or diagnostic, and the Company will negotiate in good faith with the Foundation to reach agreement on such pandemic response project.
(f) Access to Products Developed for Excluded Diseases. If the Company obtains regulatory approval for any product(s) for the treatment or prevention of any of the Excluded Diseases and has not entered into a binding agreement with a third party on an exclusive basis with respect to the manufacturing, distribution and/or commercialization of such product, then the Company agrees to consider in good faith any request from the Foundation regarding providing access to such product in Developing Countries at an affordable price. The parties acknowledge that if the Foundation requests such access, providing access may require further financial support from the Foundation or a Foundation-supported Entity to the Company. For clarity, under no circumstances will any of the Excluded Diseases be the subject of any Additional Project unless agreed by the Company in its sole discretion.
(g) Receipt and Continuation of Licenses. The Company shall continue to maintain all necessary licenses and rights with respect to the Platform Technology and Funded Developments needed to perform the Global Access Commitments. If the Company wishes to discontinue any such license or right, it shall request the Foundation’s prior written approval (which shall not be withheld by the Foundation unreasonably). In the event that licenses described in the previous sentence are received from one or more Foundation-supported Entities, then in addition to and without jeopardizing such licenses, the Company will have the right at its own cost and without assistance from the Foundation to seek to negotiate with such Foundation supported Entity(ies) the right to also use such licensed intellectual property for other applications.
(h) Pricing and Volume Commitments. The Company will make available in Developing Countries all Products developed and commercialized pursuant to a Project (i) at or below the price set forth in the applicable TPP and (ii) in quantities meeting or exceeding those set forth in the applicable statement of work (or other applicable global access agreements between the Foundation and the Company), provided that if the Fully Loaded Costs exceed the price set forth in the applicable TPP then the Company will make such Product available at the Fully Loaded Costs, unless the parties mutually agree otherwise. If a Product is to be sold at Fully Loaded Costs in accordance with the foregoing provision, and the relevant buyer is an affiliate or any other related person (nahestehende Person) within the meaning of the German tax law of the Foundation, then the Company will make such Product available to such relevant buyer at Fully Loaded Costs plus an arm’s-length markup of up to 10% (as applicable), provided, however, that (x) the competent German tax office responsible for the taxation of the Company confirmed in a binding ruling (verbindliche Auskunft) pursuant to Sec. 89 para. 2 of the German Tax Code (Abgabenordnung) that a sale at Fully Loaded Costs without a profit markup would otherwise result in a hidden profit distribution (verdeckte Gewinnausschüttung) under German tax law and the Company and the Foundation have, in good faith, agreed on a then applicable profit mark-up of up to 10% or (y) a respective markup is applied with the Foundation’s prior written consent. Due to [***], it is likely that [***].
(i) Build Out of Infectious Diseases Capabilities. Within [***] of the Closing of the Foundation Investment, the Company will implement a plan for the build out of the Company’s infectious disease capabilities, excluding manufacturing, that is reasonably acceptable to the Foundation. Such plan will include [***] and further development of the Platform Technology in order to enable the Company to conduct the HIV Project, the TB Project and any Additional Projects and achieve the Global Access Commitments. The Company will submit any subsequent proposed changes to such plan in advance to the Foundation for approval (which approval shall not be unreasonably withheld or delayed). The Company will complete the build out according to the approved plan utilizing a portion of the Foundation Investment. In addition, the Company will provide information to the Joint Steering Committee regarding the Company’s plans for the build out of manufacturing capabilities to produce infectious disease products as such plans become available.
(j) Joint Steering Committee. The Foundation and the Company will each designate three individuals who are subject matter experts to be part of a joint steering committee (the “Joint Steering Committee”) that will provide a forum for discussion of the application of the Platform Technology and the progress of each of (i) the HIV Project, (ii) the TB Project and (iii) all Additional Projects. The Joint Steering Committee will decide [***]. A decision by the Joint Steering Committee [***] shall not in any way limit or restrict the Foundation’s right to continue further development of such Project or any other Project in accordance with Section 3(d). For the avoidance of doubt, the Joint Steering Committee shall have no authority to amend any statement of work with respect to a Project and any such amendment requires the mutual agreement of the Foundation and the Company.
The Joint Steering Committee will meet at least once quarterly via teleconference and at least once annually in-person. With the agreement of both the Foundation and the Company and subject to the execution of appropriate confidentiality agreements, third parties may be invited from time to time to participate in certain Joint Steering Committee discussions. Decisions made at the Joint Steering Committee must be mutually agreed upon by each of a majority of the individuals designated by the Foundation and a majority of the individuals designated by the Company; provided that if the Joint Steering Committee determines that a change is needed to the scope of work for the HIV Project or TB Project and such change would require a change to the Platform Technology that the Company reasonably believes has a low probability of scientific or technical success or is reasonably likely to have a material adverse effect on the Company, then such change will require the Company’s consent. Other than the decision described in the preceding sentence, [***], then such matter will be considered a Dispute and will be resolved in accordance with the dispute resolution procedure set forth in Section 20.
(k) Publication; Access to Data and Information. The Company will (in addition to the publication requirements of any grant agreement with the Foundation):
(i) publish the results and information developed in connection with each Project 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 covering the development and Platform Technology itself. 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; and
(ii) promptly provide to the Foundation from time to time, upon the Foundation’s request and in a format that is acceptable to the Foundation, access to data and information regarding the Projects (including information necessary and sufficient to support the utilization of the Company’s Platform Technology by partners who are collaborating on the Projects as set forth in the applicable statement of work (taking into account the need to protect the intellectual property of such Platform Technology)), the reasonably contemplated use of the Platform Technology and Funded Developments for such Projects (taking into account the need to protect the intellectual property of such Platform Technology), and the considerations made by the Company with respect to accessibility, affordability and cost effectiveness.
(l) 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 or a Foundation-supported Entity’s ability to exercise its rights or the Company’s ability to perform its obligations under this Letter Agreement (including the Global Health License and the Foundation’s right to require Additional Projects from the list of diseases set forth in Part A of Appendix C). The Foundation will not be required to take any action or enter into any arrangement or agreement that would limit or restrict the Foundation’s ability to exercise its rights under this Letter Agreement.
(m) Global Health License
(i) Global Health License. In connection with and relating to the Projects, the Company hereby grants the Foundation, effective immediately, a worldwide, non-exclusive, non-terminable (subject to the terms of any relevant in-licenses), perpetual, royalty-free license (with the right to sublicense with the limitations specified in this Letter Agreement) under the Funded Developments and the Platform Technology to the extent required to use, reproduce, modify, make, distribute, sell, offer-for-sale, import, and otherwise dispose of any Product for the purpose of benefiting poor and needy people in Developing Countries (“Global Health License”). The Global Health License is a presently granted license. To the extent the foregoing Global Health License includes the grant of sublicense rights under intellectual property rights owned by a third party, the grant of such rights is made subject to the terms and conditions of the in-license agreements that are in existence and disclosed to the Foundation prior to the date of this Letter Agreement and set forth in Appendix F. As consideration for the Global Health License and the licenses granted pursuant to Sections 3(d)(v)(A) and 3(d)(v)(B) only, the Foundation will make a onetime lump sum payment to the Company in the amount of [***] (the “License Fee”). The License Fee is due and payable within ten (10) Business Days after Closing of the Foundation Investment.
(ii) [***].
(iii) Exercise Events. The Foundation will not exercise its rights under the Global Health License (including its sublicensing rights) unless at least one of the following occurs (each, an “Exercise Event”):
(A) a Charitability Default; or
(B) the Company (including any successors or assigns or Affiliates holding intellectual property rights applicable to the Projects) (1) institutes any bankruptcy, insolvency proceeding, appointment of a receiver, trustee and/or (preliminary) insolvency administrator or (preliminary) custodian, or legal proceedings in relation to a suspension of payments, moratorium of any indebtedness, 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 (2) any such proceeding is instituted against the Company which remains undismissed or unstayed for a period of [***] days or (3) ceases to conduct business in the ordinary course or is determined to no longer be a going concern, or – in case German insolvency laws do apply, is unable to pay its debts as they fall due within the meaning of Section 17 of the German Insolvency Code or is over-indebted within the meaning of Section 19 of the German Insolvency Code.
If either the Foundation or the Company becomes aware of an Exercise Event, it will promptly notify the other party in writing of the occurrence of such Exercise Event; provided that failure by the Foundation to provide such notice will not affect the Foundation’s rights hereunder.
(iv) Limitations on Sublicense Rights. The right to sublicense included in the Global Health License is to (A) the Funded Developments and (B) Platform Technology; provided that in the case of Platform Technology, the right to sublicense is limited to the Platform Technology that is required to exploit the applicable Product(s). In addition, the Foundation will notify the Company in advance of granting a sublicense to such Funded Developments and/or Platform Technology and the Company will have the right to object to such sublicense if (1) [***] or (2) [***]. The Foundation will require any sublicensee to agree to comply with the applicable terms of this Letter Agreement, including the obligations related to the de-blocking license pursuant to Section 3(m)(ii) above.
(n) Cooperation; Technology Transfer. In connection with the Foundation’s exercise of the Global Health License and subject to the limitations in this Section 3(n), the Company will take further actions, including technology transfer (subject to appropriate confidentiality obligations), as would be commercially reasonable industry practice at the time with respect to enabling the Foundation or a proposed sub-licensee to effectively exercise the applicable Global Health License for the sole purpose of using the licensed technology in order to develop and manufacture the relevant Products for the purpose of benefiting people in Developing Countries (including the right to reference regulatory filings related to the applicable Products).
The technology transfer commitments described above apply to (i) the Funded Developments and (ii) Platform Technology; provided that in the case of Platform Technology, the technology transfer commitments will only apply to Platform Technology that is required to exploit the applicable Product(s). In addition, the Company will have the right to object to the technology transfer obligations with respect to the Funded Developments and relevant Platform Technology listed above [***].
If the Foundation is not able to identify a potential sublicensee, [***], then [***] will apply.
(o) Intellectual Property Rights. The Company represents and covenants that [***].
(p) Duration of Global Access Commitments. The Global Access Commitments (including with respect to the Funded Developments (and to the Platform Technology to the extent covered by the Global Health License and the licenses granted pursuant to Sections 3(d)(v)(A) and 3(d)(v)(B))) will be ongoing and will continue for as long as the Foundation exists.
(q) Responsibility. The Company will be solely responsible and liable for all activities related to the conduct of the Projects. In no event shall the Foundation be a sponsor of any clinical trial, study, product, registration, or marketing authorization or the like.
(r) Direct Competitors. If at any time during the term of this Letter Agreement the Company reasonably establishes that a [***], then the Company [***]. The Foundation [***]. The Company agrees [***].
4. Survival of Global Access Commitments.
In the event of (i) any Acquisition Transaction or (ii) the sale, exclusive license, or other transfer of the Platform Technology or the Funded Developments, the Global Access Commitments will survive and be assumed in full by the purchaser, transferee, licensee, or acquirer either in a written agreement that is reasonably acceptable to the Foundation or by operation of law (if the Company is the surviving entity in the Acquisition Transaction) and the Company will take all action necessary to ensure such assumption. Upon request, the Company will provide a redacted copy of the underlying transaction documents to the Foundation evidencing such assumption (or continuation of the Company as the surviving entity). For clarity, notwithstanding anything to the contrary in this Letter Agreement, the Foundation’s rights hereunder that exist on the date of the Acquisition Transaction or sale, exclusive license, or other transfer of the Platform Technology or the Funded Developments will not be terminated by such transaction.