Master Alliance Provisions Guide (MAPGuide)

How Can Agreement Provisions
Ensure Sustainable Access to Funded Products?

Ensuring the sustainability of access to a medical product requires the interconnection of many factors including sufficient demand from willing and able buyers for the product, support of wider health systems including harmonized regulatory processes, resilient supply chains, distribution networks, sufficient healthcare facilities, and local community support

This commentary focuses on the role that product development funding agreements can play in facilitating sustainability through provisions that require:

1. Sustainable Price

As discussed in more detail here, an affordable price is key to achieving equitable access to a funded product. However, not only must the price be one that purchasers for the target markets are willing to pay, it must also be one that makes it feasible for the developer or manufacturer to continue production and commercialization of the product. Partnering agreements can address the need for a sustainable price through provisions which stipulate that the price will be commercially viable or that a partner will not be required to sell the product for less than their cost of goods.

Examples from the MAPGuide

The Parties acknowledge that the price of the [product] is critical to achieving Equitable Access during the Pandemic Period. Accordingly, [Developer] agrees that its pricing shall be reasonable to achieve Equitable Access for populations in need of a [product] as well as an appropriate return on investment for vaccine manufacturers that make on-going supply commercially sustainable.

Source: taken from a development funding agreement between CEPI (Funder) and Novavax (Developer) for a COVID-19 vaccine. Read in context.

[…] Consistent with [Funder]s Equitable Access Policy, [Funder] is also committed to supporting Equitable Access so that the economics are sustainable to the manufacturer.

With respect to pricing, the [Developer] will ensure that : to the extent that [Developer] commercializes Product which utilizes or otherwise benefits from, whether directly or indirectly, any Project Result, (i) the distribution of the Product in Non-Traveler’s Market Countries that are LMICs will be [***], and (ii) the distribution of the Product in Non-Traveler’s Market Countries that are not LMICs will be at [***]. In any case, “sustainable price” shall never be below [Developer]’s manufacturing costs.

Source: taken from a development funding agreement between CEPI (Funder) and Valneva (Developer) for manufacturing and late-stage clinical development of a Chikungunya vaccine. Read in context.

The [Developer] further agrees that it will not reject any Projects proposed by the [Funder] unless the [Developer] can demonstrate that accepting such Project would be reasonably likely to have a material adverse effect on the [Developer] (“Good Reason”). By way of example, the [Developer] agrees that it will not constitute Good Reason for the [Developer] to reject a Project because the [Developer] could make a higher profit by performing other work, but the [Developer] will not be required to accept a Project on terms that would cause the [Developer] to operate at a loss without any offsetting benefit.

Source: taken from a development funding agreement between the Bill & Melinda Gates Foundation (Funder) and CureVac (Developer) in relation to the Foundation’s investment in Series B shares in CureVac. The investment is to be used solely to fund a new manufacturing facility which can be used to manufacture vaccines and drugs in support of the Foundation’s equitable access objectives, or to continue development and use of CureVac’s mRNA platform technology to advance drug and vaccine candidates in support of the equitable access objectives. Read in context.

2. Continued supply

A long-term, reliable supply of a product is also critical to ensuring sustainable access. This may be reflected in partnering agreement provisions through obligations to ensure a continued supply of the product to target markets beyond the end of the agreement term. The required supply period may take into account factors such as the likely duration of need for the product and the likely timeframe for development of a competitive market of comparable products. In addition to direct continued supply requirements for a developer, funding agreements may also provide for technology transfer to one or more third party manufacturers that are likely to be willing and able to meet supply (and pricing) needs in the long term. These provisions are discussed in more detail here.

Examples from the MAPGuide

In the event of successful completion of the Phase 1 study of the [product] as described in the Project, and the [Funder] has made all payments to Icosavax in accordance with the terms of the Grant Agreement, [Developer] will take reasonable steps to obtain additional funding for completing the activities necessary to further develop the [product] beyond the Phase 1 study.  Within [***] of the [***], [Developer] will have received or will have a [***] to further develop, manufacture, and/or distribute the [product]. If [Developer] [***] and continues the development and commercialization of the [product], the following terms apply: […]

Annual Volume Commitment Term. [Developer] and/or its manufacturing and/or commercial partner(s) will provide the Annual Volume Commitment for a [***] period commencing on the date of first supplying the [product] to a Public Sector Purchaser and ending on the [***] anniversary thereof (the “Annual Volume Commitment Term”).

Source: taken from a grant agreement between the Bill & Melinda Gates Foundation (Funder) and Icosavax (Developer) for the preparation of an Investigational New Drug (IND) Application and conduct of a phase I first-in-human clinical trial of a virus-like particle (VLP) vaccine against SARS-CoV2. Read in context.

Upon an election to make and sell a [product] to Public Sector purchasers in Developing Countries, [developer] shall manufacture, supply and sell, or cause to be manufactured, supplied and sold, the [product] for use in designated Developing Countries for a period of time to be agreed upon by the Parties following licensure of a [product[ in a Developing Country.

Source:  taken from a development funding & collaboration agreement between PATH (Funder) and Aridis (Developer) for the formulation development of a rotavirus vaccine. Read in context.

[Developer] shall: […] After the Pandemic Period, for a period lasting until the later of (i) five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date; subject to the same limitations as Section [x], if [Funder] determines in its reasonable discretion in consultation with the [Developer] that a regional but not a global Outbreak exists, then [Developer] shall offer a percent of the total quantity of the [Product] produced for purchase by Gavi, [Funder] or their respective designees pursuant to Clause [x] equal to the Volume Commitment Percentage multiplied by the percentage of the world population that resides in the region in which the Outbreak exists; save that where a regional Outbreak exists in a relatively small population (as reasonably determined by [Funder]), the Parties shall discuss in good faith an increase in the Volume Commitment Percentage in order to adequately address such an Outbreak. For example, if the Volume Commitment Percentage was ** and there was an Outbreak in Africa, then, based on 2020 census data, approximately ** of [Product] would be offered for purchase by Gavi; […]

After the Pandemic Period, for a period lasting until the later of (i) five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date, [Developer] shall continue to produce and supply the Project Vaccine for purchase by Gavi, [Funder] or their respective designees pursuant to Clause [x], as is required by Gavi, [Funder] or their respective designees to meet the needs of AMC Countries for so long as there is demand for such supply, which quantity shall be set out in an advanced purchase agreement between the [Developer] and Gavi, [Funder] or their respective designees.

Related definitions: 

  • “Outbreak” means the COVID-19 outbreak caused by the SARS-CoV-2 virus or any strain, mutations and related recurrences of such virus.
  • “Pandemic Period” means the period of time beginning on 30 January 2020, when the World Health Organization (or “WHO”) declared COVID-19 to be a Public Health Emergency of International Concern (or “PHEIC”), and ending on the earlier of (1) the date on which WHO declares that the COVID-19 PHEIC is over or (2) the date determined by [Funder], in its reasonable discretion in consultation with the [Developer] and based on epidemiological data published by WHO.
  • “Volume Commitment Percentage” means the relevant percentage of the [Developer]’s capacity to produce [Product] together with Trusted Manufacturer, where the relevant percentage shall be calculated as follows: **% for any [Product] for which [Funder] provides preclinical funding, **% for any [Product] for which [Funder] funds through Phase 1 clinical study, **% for any [Product] for which [Funder] funds through Phase 2 clinical study, **% for any [Product] for which [Funder] funds through Phase 3 clinical study, and **% for any [Product] for which [Funder] funds through to (i) approval and registration as set out in the iPDP; (ii) WHO pre-qualification or emergency use listing; and (ii) reasonably sufficient commercial manufacturing capabilities as required to meet [Developer]’s obligations hereunder. In the event that [Funder] co-funds with a third party organization, [Developer], [Funder] and the third party organization will negotiate an appropriate Volume Commitment Percentage commensurate with the respective interests of the party, funding contributions and stage of investment (provided always that such Volume Commitment Percentage shall be no lower than the Volume Commitment Percentage applicable to the funding stage immediately prior to the latest stage to which [Funder] has provided funding).

Source: taken from an outbreak response agreement between CEPI (Funder) and Variation Biotechnologies Inc (Developer) for the development of COVID-19 vaccine candidates. Read in context.

3. Access licenses

Statistically, a high proportion of product development projects will fail from a scientific, safety and/or efficacy perspective. However, projects can also be at risk of failure when a developer cannot or will not fulfill its obligations even though the project is viable from a scientific perspective.

Partnering agreements can mitigate the risk of project failure in these instances, and therefore support sustainable access to the funded product, through the use provisions that grant rights to a funder to either take over the project activities themselves or to reassign the activities to a third party. A number of major global health funders have developed their own terminology to describe these rights, for example: Humanitarian License (Bill & Melinda Gates Foundation), Global Access License (Bill & Melinda Gates Foundation), Public Health License (CEPI), march-in rights (U.S. Government), Access Rights (CARB-X), step-in rights (Wellcome Trust). For the purpose of this commentary, they are collectively referred to as ‘access licenses’.

The specific conditions of an access license vary depending on the context of a particular partnering agreement. Some of the factors used to establish when and how an access license is exercised are outlined below, additional considerations for access licenses are discussed here

a. License triggers: Some access licenses may be exercised by the funder at any point after execution of the partnering agreement. However, the exercise of access licenses is often conditional on the occurrence of a trigger event, or condition precedent. Access license triggers may also be linked to termination provisions. Examples of these conditions include if the developer:

    • Does not meet project milestones in a timely manner;
    • Does not make progress to exploit the project intellectual property;
    • Cannot achieve a low enough cost of goods to result in an affordable price for the final product;
    • Cannot meet product supply commitments;
    • Breaches the terms of the partnering agreement;
    • Makes a strategic decision to discontinue development of the product; and/or
    • Declines to undertake additional activities to respond to an outbreak.

Some partnering agreements also include a cure period (i.e. a specified number of days for the developer to resolve the issue) or dispute resolution process before the license can be exercised.

Examples from the MAPGuide

Humanitarian License – no triggers required to exercise: Subject to applicable laws and for the purpose of achieving Global Access, You grant the [Funder] a nonexclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid up, sublicensable license to make, use, sell, offer to sell, import, distribute, copy, create derivative works, publicly perform, and display Funded Developments and Essential Background Technology. “Essential Background Technology” means Background Technology that is: (a) owned, controlled, or developed by You, or in-licensed with the right to sublicense; and (b) either incorporated into a Funded Development or reasonably required to exercise the license to a Funded Development. You confirm that You have retained sufficient rights in the Funded Developments and Essential Background Technology to grant this license. You must ensure this license survives the assignment or transfer of Funded Developments or Essential Background Technology. On request, You must promptly make available the Funded Developments and Essential Background Technology to the [Funder] for use solely under this license. If You demonstrate to the satisfaction of the [Funder] that Global Access can best be achieved without this license, the [Funder] and You will make good faith efforts to modify or terminate this license, as appropriate.

Related definitions: 

  • “Global Access” requires that (a) the knowledge and information gained from the Project will be promptly and broadly disseminated; and (b) the Funded Developments will be made available and accessible at an affordable price (i) to people most in need within developing countries, or (ii) in support of the U.S. educational system and public libraries, as applicable to the Project.
  • “Funded Development” means the products, services, processes, technologies, materials, software, data, other innovations, and intellectual property resulting from the Project (including modifications, improvements, and further developments to Background Technology).

Source: this is the standard Humanitarian License provision language referenced in the Bill & Melinda Gates Foundation’s Global Access Statement. These provisions can be found in a number of the Foundation’s grant agreements such as this one with Icosavax for the preparation of an Investigational New Drug  (IND) Application and conduct of a phase I first-in-human clinical trial of a virus-like particle (VLP) vaccine against SARS-CoV2. 

“Charitability Default” means that [Developer]:

  • fails to comply with the restrictions on the use of funds or the other related U.S. tax obligations set forth in the Grant Agreement or the requirements set forth in this GACA;
  • commits a material breach of term of the Grant Agreement or this GACA;
  • commits gross negligence, fraud or willful misconduct
  • or makes a strategic decision to discontinue the Product development and/or commercialization of the Product which meets the Minimum TPP; or 
  • experiences a Change of Control or Transfer in violation of section [x] of this GACA; or
  • experiences any Force Majeure Event, failure to cure or nonperformance exceeding 150 days, unless otherwise agreed to by the Parties in writing.

Notice of Charitability Default. Except as to Charitability Default under [Force Majeure, failure to cure or nonperformance], each Party agrees that if it becomes aware of a Charitability Default it will promptly notify the other Party, and [Developer] shall thereafter provide to the [Funder] a proposed strategy to cure the Charitability Default within forty-five (45) days of notification. Notwithstanding anything in this GACA to the contrary, the [Funder] will not lose any rights or remedies solely as a result of a failure to notify [Developer] after it becomes aware of a Charitability Default, provided that such failure to notify shall not otherwise impede, prevent, or materially and detrimentally impact the ability and/or expense associated with [Developer]’s cure of such Charitability Default. In addition, [Developer] agrees to promptly notify the [Funder] of any facts and circumstances which could reasonably cause a Charitability Default hereunder (including with respect to any Charitability Default under Section [x] through [x]). Subject to Section [x], if [Developer] fails to either cure the Charitability Default within ninety (90) days of notice of a Charitability Default (the “Cure Period”) or if such Charitability Default requires additional time to be cured as agreed by the parties (“Extended Cure Period”) and the [Developer] fails to use reasonable and diligent efforts to cure such Charitability Default, then the [Funder] will immediately be granted the Global Access License rights set forth in this Section 6. For the avoidance of doubt, if the period of the Force Majeure event or any attempt to cure or any nonperformance (including due to Force Majeure) exceeds one hundred and fifty (150) days from the notice, unless otherwise agreed to by the Parties in writing, the [Funder] shall immediately be granted the Global Access License as set forth in Section [x].

License Triggers: If a Charitability Default is not cured by the end of the Cure Period or Extended Cure Period, effective immediately, [Developer] hereby grants a non-exclusive, irrevocable, perpetual, sublicenseable, royalty-free and fully-paid up, worldwide […] license to the [Funder] to all intellectual property, technology, know-how, and information owned, controlled or used (subject to reasonably sublicensability by third party licensor(s)) by the [Developer] at the time of such Charitability Default that are necessary or useful to research, develop, make, have made, offer-for-sale, sell, import, export, distribute or use the Product, such license solely to research, develop, make, have made, offer-for-sale, sell, import, export, distribute or use Product for Maternal Immunization intended for the benefit of people in Developing Countries (“Global Access License”). Upon a Global Access License, [Developer] may reasonably seek to assign any and all such intellectual property rights, including third-party licenses, to the [Funder] or the [Funder]’s licensee as appropriate, and the [Funder] will reasonably work with the [Developer] to accept such assignment.

Source: Taken from a global access commitments agreement between the Bill & Melinda Gates Foundation (Funder) and Novavax (Developer) for the development of an affordably-priced RSV vaccine for use in maternal immunization to provide RSV protection in low income countries. Read in context.

The exercise of Access Rights shall be predicated on the [Funder]’s determination that:

(i) Such action is necessary because the [Developer], licensee or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve Practical Application of the Project IP Rights in such field of use;

(ii) Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the [Developer], assignee or their licensees; or

(iii) Such action is necessary to meet requirements for the [Funder]’s charitable purpose and such requirements are not reasonably satisfied by the [Developer], assignee or licensees.

Exercise of Rights.

(i) The following procedures shall govern the exercise of Access Rights.

(ii) Whenever the [Funder] receives information that it believes might warrant the exercise of Access Rights, before initiating any proceeding to exercise Access Rights, it shall notify the [Developer], its assignee or exclusive licensee, as applicable, in writing of the information and request informal written or oral comments from the [Developer], its assignee or exclusive licensee as well as information relevant to the matter. In the absence of any comments from the [Developer] within 30 days, the [Funder] may, at its discretion, proceed with the procedures below. If a comment is received within 30 days, or later if the [Funder] has not initiated the procedures below, then the [Funder] shall, within 60 days after it receives the comment, either initiate the procedures below or notify the [Developer], its assignee or exclusive licensee, in writing, that it will not pursue Access Rights on the basis of the available information.

(iii) A proceeding to exercise Access Rights shall be initiated by the issuance of a written notice by the [Funder] to the [Developer] and its assignee or exclusive licensee, as applicable and if known to the [Funder], stating that the [Funder] is considering the exercise of Access Rights. The notice shall state the reasons for the proposed exercise of Access Rights in terms sufficient to put the [Developer] on notice of the facts upon which the action would be based and shall specify the field or fields of use in which the [Funder] is considering requiring licensing. The notice shall advise the [Developer], its assignee or exclusive licensee of its rights, as set forth in this section. The determination to exercise Access Rights shall be made by the Director of the [Funder] or designee.

(iv) Within 30 days after the receipt of the written notice of [Funder]’s intent to exercise Access Rights, the [Developer], its assignee or exclusive licensee may submit in person, in writing, or through a representative, information or argument in opposition to the proposed exercise of Access Rights, including any additional specific information which raises a genuine dispute over the material facts upon which the exercise of Access Rights is based. If the information presented raises a genuine dispute over the material facts, the Director of the [Funder] shall undertake or refer the matter to the Director’s designee for fact-finding.

(v) Fact-finding shall be conducted in accordance with the procedures established by the [Funder]. Such procedures shall be as informal as practicable and be consistent with principles of fundamental fairness. The procedures should afford the [Developer], its assignee or exclusive licensee the opportunity to appear with counsel, submit documentary evidence, present witnesses and confront such persons as the [Funder] may present. A transcribed record shall be made and shall be available at cost to the [Developer], its assignee or exclusive licensee upon request. The requirement for a transcribed record may be waived by mutual agreement of the [Developer], its assignee or exclusive licensee and the [Funder]. Any portion of the proceeding, including a fact-finding hearing that involves testimony or evidence relating to the utilization or efforts at obtaining utilization that are being made by the [Developer], its assignee, or licensees shall be closed to the public, including potential licensees. The [Funder] shall not disclose any such information obtained during an Access Rights proceeding to persons outside the [Funder] (including [Funder] Funders) except when such release is authorized by the [Developer], its assignee or exclusive licensee.

(vi) The person conducting the fact-finding shall prepare or adopt written findings of fact and transmit them to the Director of the [Funder] or designee promptly after the conclusion of the fact-finding proceeding along with a recommended determination. A copy of the findings of fact shall be sent to the [Developer], its assignee or exclusive licensee by registered or certified mail. The [Developer], its assignee or exclusive licensee and the [Funder] representatives will be given 30 days to submit written arguments to the Director of the [Funder] or designee; and, upon request by the [Developer], its assignee or exclusive licensee, oral arguments will be held before the Director of the [Funder] or designee that will make the final determination.

(vii) In cases in which fact-finding has been conducted, the Director of the [Funder] or designee shall base his or her determination on the facts found, together with any other information and written or oral arguments submitted by the [Developer], its assignee or exclusive licensee and the [Funder] representatives, and any other information in the record. The consistency of the exercise of Access Rights with the objectives of promoting the utilization and public availability of inventions arising from funded research, and protecting the public against nonuse or unreasonable use of inventions shall also be considered. In cases referred for fact-finding, the Director of the [Funder] or designee may reject only those facts that have been found to be clearly erroneous, but must explicitly state the rejection and indicate the basis for the contrary finding. Written notice of the determination whether Access Rights will be exercised shall be made by the Director of the [Funder] or designee and sent to the [Developer], its assignee or exclusive licensee by certified or registered mail within 90 days after the completion of fact-finding or 90 days after oral arguments, whichever is later, or the proceedings will be deemed to have been terminated and thereafter no Access Rights based on the facts and reasons upon which the proceeding was initiated may be exercised.

Source: taken from the template CARB-X (Funder) cost-reimbursement agreement with subrecipients (Developer) for the early stage development of antibiotics, vaccines, and rapid diagnostics against bacterial threats. In the case of this agreement, the Funder receiving the Access Rights is the Wellcome Trust, a funder of CARB-X. Read in context.

[Funder] may exercise the Public Health License by notice in writing to the Partner on the occurrence of one or more of the events set out below (each a “Condition Precedent” and together the “Conditions Precedent”):

  • except where failure is due to reasonable scientific, safety or regulatory issues, the Partner:

(i) materially fails to Develop the Platform and/or the Project Vaccines in accordance with the Work Package Statements or Additional Work Package Statements as they relate to Products and/or the IPDP; or

(ii) fails to use Reasonable Efforts to satisfy any Milestone Criteria or Stage Gate Criteria by the relevant Milestone Date or Stage Gate Date; and in each case, fails to remedy the situation within [*****] of the receipt by Partner of notice from [Funder] identifying the failure and requiring its remedy (or as otherwise as agreed in writing by the Parties);

  • [Funder] terminates the Agreement in accordance with Clause [x] [breach or insolvency] below
  • in the event of an Outbreak or Outbreak risk:

(i) the Partner does not exercise the Partner Right of First Refusal or declines to enter into an agreement under Clause [x] [additional product development for outbreak response];

(ii) the Partner informs [Funder] that it will not be able to Develop and Manufacture Project Vaccine in accordance with the [Funder] Production Timeframe, in sufficient quantities and at an appropriate cost given the nature and health implications of the Outbreak or Outbreak risk

(iii) the Partner’s Development and Manufacture of Project Vaccine for use in the Field does not achieve the [Funder] Production Timeframe, in appropriate quantities and/or at an appropriate cost given the nature and health implications of the Outbreak or Outbreak risk; or

(iv) [Funder], in good faith, based on actual non-performance or late performance has reason to assume that the Partner is unable or unwilling to Develop or Manufacture Project Vaccine for use in the Field in sufficient quantities in accordance with the [Funder] Production Timeframe and at an appropriate cost given the nature and health implications of the Outbreak or Outbreak risk;

  • if by the date [*****] following successful completion of the Project the Cost of Goods for the Project Vaccines for use in the Field exceeds the level public service agencies agree is affordable based on objective economic criteria to be determined between the Parties for use in the Affected Territory;
  • if by the date [*****] following successful completion of the Project, the Cost of Goods for a specific Project Vaccine for use in the Field exceeds the level public service agencies agree is affordable based on objective economic criteria to be determined between the Parties for use in the Affected Territories;
  • where one or more Project Vaccine becomes subject to a pattern of serious adverse events (as defined in the ICH Guidelines) or either Party receives notice from a Regulatory Authority, independent review committee, a data safety monitoring board or another similar clinical trial or post-marketing body alleging significant concern regarding a patient safety issue, in each case in which [Funder], in good faith, reasonably believes would seriously impact the long-term viability of one or more of the Project Vaccines for use in the Field;
  • there are material Safety Issues and/or quality issues in relation to use of the Platform that will seriously impact the long-term viability of the Platform; and
  • on termination of the Agreement where the Partner is the Defaulting Party.

Disputes relating to the occurrence of a Conditions Precedent. In the event that the Parties dispute the occurrence one or more of the Conditions Precedents, the matter shall be resolved in accordance with the dispute resolution procedure set out at Clause 22 provided however that any arbitration decision shall be made within [*****] of the date of the reference to arbitration.

Whilst the dispute is subject to arbitration, on the occurrence of an Outbreak in the Field and/or risk of an Outbreak in the Field, [Funder] shall be entitled to exercise the Public Health License solely to have Developed Project Vaccines, and to have Manufactured and marketed Product via the Trusted Manufacturer for use in the Field in the Affected Territory to address the Outbreak or Outbreak risk. In such event, the Partner shall use all reasonable endeavors to give assistance to [Funder] and/or the Trusted Manufacturer(s) including: (i) transferring to the Trusted Manufacturer(s) all Data, Materials, Confidential Information and Regulatory Filings (including the Master File) necessary or desirable for [Funder] to conduct such Development of Products including Project Vaccines, Manufacturing and marketing; and (ii) executing any necessary documents.

Source: taken from a development funding agreement between CEPI (Funder) and CureVac (Developer) for the development of CureVac’s mRNA platform for the rapid manufacturing of vaccines against infectious diseases. Read in context.

  • if no member of the [Developer] Group or sub-licensees of the [Developer] Group is taking reasonable steps to Develop or Exploit any Programme Intellectual Property or Products for a particular indication for a consecutive period of [**] months or more following completion of the Programme, and, upon receipt of a written notice from the [Funder] served at the end of, or after such [**] month period requesting that the Programme Intellectual Property is Developed and/or Exploited, does not for an additional [**] months take any reasonable steps in this regard; or
  • at any time after the first sale of a Product in a Major Market in a particular indication, no [Developer] Group member or any sub-licensees of any [Developer] Group member have taken reasonable steps to Develop and/or Exploit that Product in that particular indication in another Major Market for a consecutive period of [**] months, and, upon receipt of written notice from the [Funder] after such [**] month period requesting that the relevant Product is Exploited in such other region(s) and in such indication, does not for an additional [**] months take reasonable steps in this regard; 

then, following the expiry of the time periods set out above, the [Funder] shall have the option in its sole discretion by giving written notice to [Developer] to become the Exploiting Party and to take responsibility for the Development and Exploitation of such Programme Intellectual Property and Products in the relevant indication(s) and region(s), which includes discretion to make any and all decisions (in consultation with the [Research Steering Group]) regarding the negotiation, acceptance and conclusion of terms for any agreement regarding the Development and Exploitation of such unexploited Programme Intellectual Property (including Development and Exploitation by way of licence, sale, materials transfer or other transfer of rights, as well as any transaction which involves placing such unexploited Programme Intellectual Property into a separate corporate vehicle) in such region.Related definitions: “Major Market” means any of the United States, the United Kingdom, Japan, and any two of the following: France, Spain, Germany and Italy.

Source: Taken from a research funding agreement between the Wellcome Trust (Funder) and PTC Therapeutics (Developer) under the Trust’s Seeding Drug Discovery Strategic Award Programme for the discovery and development of a novel glioblastoma treatment. Read in context.

  • [Developer] agrees that, with respect to any Subject Invention in which it has acquired title, the Government may request [Developer], an assignee, or exclusive licensee of a Subject Invention to grant a non-exclusive license, within the Field of use to a responsible US-based third party licensee, upon terms that are reasonable under the circumstances. If [Developer], assignee, or exclusive licensee initially refuses such a request, the Government may obligate [Developer] to grant such a license subject to Article [x]  below if the Government determines that:
    1. Such action is necessary because [Developer] or assignee has not taken steps (or is not expected to take within a reasonable time), consistent with the intent of this Project Agreement, to achieve Practical Application of the Subject Invention; or
    2. Such action is necessary to alleviate the following urgent health or safety needs not reasonably satisfied by the contractor that affect the United States and that are not reasonably satisfied by [Developer], assignee, or their licensees:

    (i) declaration for Public Health Emergency by the Secretary of the Government;

    (ii) determination that there is a significant potential for a public Health emergency that has a significant potential to affect the national security or public health of U.S. citizens as determined by the Secretary of the Government; or

    (iii) declaration by WHO Director General of a public health emergency of international concern.

Source: Taken from an agreement between the US Government (Funder) and Janssen Pharmaceuticals (Developer) for the rapid research, development and large-scale manufacturing of a COVID-19 vaccine. Read in context.

In recognition of the Government’s significant funding for the development and manufacturing of the product in this Project Agreement and the Government’s need to provide sufficient quantities of a COVID-19 vaccine to protect the United States population, the Government shall have the remedy described in this section to ensure sufficient supply of the product to meet the needs of the public health or national security. This remedy is not available to the Government unless and until both of the following conditions are met: 

(a) [Developer] gives written notice, required to be submitted to the Government no later than 15 business days, of: 

(i) any formal management decision to terminate manufacturing of this product vaccine prior to delivery of 100 million doses to USG;

(ii) any formal management decision to discontinue sale of this product vaccine to the Government prior to delivery of 100 million doses to USG; or 

(iii) any filing that anticipates Federal bankruptcy protection; and

(b) [Developer] has submitted an Emergency Use Authorization under §564 of the FD&C Act or a biologics license application provisions of §351(a) of the Public Health Service Act (PHSA). 

If both conditions listed in section (a) occur, Sanofi, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of this product vaccine with a third party for exclusive sale to the U.S. Government:

(a) a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royalty-free paid-up license to practice or have practiced for or on behalf of the U.S. Government any Sanofi Background Patent, Copyright, other Sanofi Intellectual Property, Sanofi Know-How, Sanofi Technical Data rights necessary to manufacture or have manufactured the vaccine; 

(b) necessary FDA regulatory filings or authorizations owned or controlled by Sanofi related to this product vaccine and any confirmatory instrument pertaining thereto (excluding with respect to [redacted content]); and 

(c) any outstanding Deliverables contemplated or materials purchased under this Project Agreement.

Source: Taken from an agreement between the US Government and Sanofi for the development and manufacturing of a COVID-19 vaccine. Read in context.

b. Who has the right to continue the activities: While some access licenses provide for a funder or PDP to take over the project activities directly, another common approach is for project-related development and manufacturing rights to be granted to a new partner or sublicensee. In some cases, partnering agreements provide for the advance selection of a “Trusted Collaborator” or “Trusted Manufacturer” who could take on this role. Providing for selection of a new partner can help to ensure the feasibility of exercising the license in a timely manner, particularly for funders that do not have the capacity to undertake development and manufacturing work themselves.

Examples from the MAPGuide

The Parties agree and acknowledge that in order to achieve Global Access and make the Product available and accessible in Developing Countries, certain activities may be required to occur in one or more Developed Countries, such as manufacture, distribution, or sale (such as to an entity procuring Product for use in Developing Countries). For example, the manufacture of Product (intended for use in Developing Countries) may occur in a Developed Country. Similarly, certain aspects of the distribution or supply chain may occur in (or pass through) one or more Developed Countries, e.g. the Product may be transported through a Developed Country en route to the final destination of the Product in a Developing Country. Similarly, the procurement entities which may purchase Product (for or on behalf of a Developing Country) may be located in a Developed Country or the sales transactions related thereto may occur in a Developed Country, even though the final destination of the Product is a Developing Country. Accordingly, the Global Access License hereunder is intended to permit such Developed Country activities which are incidental or necessary to making the Product available and accessible in Developing Countries.

Source: Taken from a global access commitments agreement between the Bill & Melinda Gates Foundation (Funder) and Novavax (Developer) for the development of an affordably-priced RSV vaccine for use in maternal immunization to provide RSV protection in low income countries. Read in context.

The Global Access License is sublicensable to (i) [Funder]-supported Entities, (ii) to CROs and CMOs acting on behalf of the [Funder] or the [Funder]-supported Entities or (iii) to third party licensees of the [Developer] who have entered into a collaboration and license or asset transfer agreement with the [Developer] with respect to a pathogen covered under a Project, provided, however, that if such third party licensee refuses to enter into a sublicense agreement with the [Funder] in spite of a good faith approach of the [Funder] to conclude such sublicense agreement, the [Funder] may grant a sublicense to any other third party.

Source: taken from a development funding agreement between the Gates Foundation (Funder) and CureVac (Developer) for a COVID-19 vaccine. Read in context.

[Funder] shall be entitled to sublicense Project Results, Enabling IP and Background IP included in the Public Health License in accordance with this Clause [x]. Each sublicense shall be in writing and [Funder] shall require that each sublicensee complies with the terms of the Public Health License, and if receiving a sublicense to Third Party Background IP, also complies with the terms of the Third Party Background IP license agreement. If a license to Third Party Background IP does not permit further sublicensing by [Funder], [Developer] agrees to directly grant [Funder]’s designee a sublicense consistent with the Public Health License, provided such third party designee agrees to comply with the terms of the Third Party Background IP license agreement, including, without limitation, any payment of sublicense fees attributable to such sublicense grant. [Funder] will remain responsible and liable for the performance of sublicenses under such sublicensed rights to the same extent as if such activities were conducted by [Funder].

Agreement between [Funder] and the Trusted Collaborator or Trusted Manufacturer. In the event that the Public Health License is exercised, [Funder] may request assignment of the relevant Trusted Collaborator or Trusted Manufacturer contracts from [Developer] or, at [Funder]’s option, endeavour to reach agreement directly with the Trusted Collaborator and/or Trusted Manufacturer, as the case may be, to perform such activities as [Funder] may deem necessary. At [Funder]’s request, [Developer] shall use [***] to facilitate the conclusion of a direct contractual relationship between the Trusted Collaborator or Trusted Manufacturer, as the case may be, and [Funder]. If those negotiations do not result in an agreement in [***], then [Funder] may grant rights under its Public Health License to a third party unilaterally designated by [Funder] as a Trusted Collaborator or Trusted Manufacturer, without approval from [Developer].

Related definitions:

  • “Trusted Collaborator” refers to a proposed third party, for example, a Sub-Awardee, under contract to [Developer] that is capable of performing the activities in agreed Work Packages, Additional Work Packages or a Project Expansion , in the event that [Developer] is unable to continue its activities under this Agreement or declines [Funder]’s request to undertake additional Work Packages or a Project Expansion
  • “Trusted Manufacturer” refers to one or more geographically dispersed manufacturing sites, under contract with [Developer], to produce Project Vaccine for use in the Field. [Developer] shall make a final designation of one or more Trusted Manufacturers, in consultation with [Funder], and prior to the start of a Phase II clinical trial.

Source: taken from a development funding agreement between CEPI (Funder) and Novavax (Developer) for a COVID-19 vaccine. Read in context. CEPI’s public health license rights under this agreement extend through to a related agreement between Novavax and Gavi for the purchase of the vaccine developed with CEPI’s funding.

 Where the circumstances described in Article [x] [March-in rights] are met, [Developer] will act promptly to negotiate in good faith with the responsible US-based third party a non-exclusive license on terms that are reasonable under the circumstances under the SI Intellectual Property Rights it controls at the time to make, have made, use, sell, offer for sale and import the relevant Subject Invention in the Field to the extent necessary to alleviate the public health emergency in the United States.

Source: Taken from an agreement between the US Government (Funder) and Janssen Pharmaceuticals (Developer) for the rapid research, development and large-scale manufacturing of a COVID-19 vaccine. Read in context.

c. Scope of the access license: Access license provisions often include restrictions on the territory and field for which the rights may be used. In particular, funders may only be permitted to use the access license to achieve the equitable access objectives of a partnering agreement, for example for supply only to a specific territory, rather than making commercial sales of the product in high-income markets.

Examples from the MAPGuide

Public Health License for Affected Territories in response to an Outbreak means a non-exclusive, fully paid-up, sublicensable license under the Project Results and Enabling Rights to develop, manufacture, market and/or supply the Product worldwide, provided that all end users of the Product are located in the Affected Territory; in each case for use in preparation for or response to an Outbreak or Increased Outbreak Preparation Need.

Source: taken from a development funding agreement between CEPI (Funder) and Valneva (Developer) for manufacturing and late-stage clinical development of a Chikungunya vaccine. Read in context.

 Subject to the Existing Agreements, in connection with and relating solely to each Project the [Developer] will grant the [Funder] a worldwide, non-exclusive, perpetual, irrevocable, fully-paid up, royalty-free license to the Funded Developments and the background intellectual property Controlled by the [Developer] that is covering the Platform Technology to the extent reasonably required to use, research, develop, make, sell, and offer-for-sale the Funded Developments for the specific Project, including the Products developed under such Project (the “Global Access License”), but any development, manufacture, sale, offer-for-sale, importation or distribution of products is limited to importation into and distribution to people in Access Countries in a manner consistent with the [Funder]’s charitable purpose.

Source: taken from a development funding agreement between the Gates Foundation (Funder) and CureVac (Developer) for a COVID-19 vaccine. Read in context.

Where the circumstances described in Article [x -March-in rights] are met, [Developer] will act promptly to negotiate in good faith with the responsible US-based third party a non-exclusive license on terms that are reasonable under the circumstances under the SI Intellectual Property Rights it controls at the time to make, have made, use, sell, offer for sale and import the relevant Subject Invention in the Field to the extent necessary to alleviate the public health emergency in the United States.

Source: Taken from an agreement between the US Government (Funder) and Janssen Pharmaceuticals (Developer) for the rapid research, development and large-scale manufacturing of a COVID-19 vaccine. Read in context.

d. Actions required upon exercise of the license: Funding agreements often set out specific actions to be taken by developer in the event that the funder exercises an access license. These include:

    • Taking commercially reasonable actions that would be expected when licensing technology to a third party;
    • Conducting a technology transfer to the funder, a “Trusted Manufacturer”, or another party nominated by the funder;
    • Providing an updated list of intellectual property rights relevant to the product or project; 
    • Providing access to relevant data, documents, and materials; and
    • Passing through opportunities for exploitation of the licensed intellectual property rights.

Examples from the MAPGuide:

 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).

Source: taken from a strategic relationship agreement between the Bill & Melinda Gates Foundation (Funder) and Arsanis (Developer) in connection with an $8 million investment by the Foundation to support a Staphylococcus aureus antibody development program. Read in context.

Upon exercise of the Public Health License and written notice to [Developer], [Developer] [***] shall:

(a) provide [Funder] with an updated list of Enabling Rights and applicable Background IP, along with an invoice for any payments due under any license agreement for Third Party Background IP attributable to the grant of the Public Health License to [Funder] or a sublicensee;

(b) provide [Funder] with a good faith schedule of key technology transfer activities and estimated costs for the technology transfer in Clause [x];

(c) [***] transfer to the Trusted Collaborator and/or Trusted Manufacturer, as the case may be, and at [Funder]’s reasonable cost, all Project Results, Project Materials described in Clause [x], all guidance, information, materials and assistance reasonably required to accomplish the Project activities identified by [Funder]; and

(d) shall be deemed to have covenanted not to sue [Funder] or designee for the exercise of the Public Health License.

Related definitions: “Enabling Rights” means rights to Intellectual Property and Project Results that could be asserted by [Developer] to block [Funder] from exercising its rights under Clause [x] [project continuity] of this Agreement. For purposes of this Agreement, Enabling Rights also includes the contractual rights under contracts executed for the Project that control the use of such items, for example, in material transfer agreements.

Source: taken from a development funding agreement between CEPI (Funder) and Novavax (Developer) for a COVID-19 vaccine. Read in context.

 If the [Funder] exercises its right to exploit any Programme Intellectual Property under Clause [x]:

  • [Developer] will exclusively licence to the [Funder] or its nominee, the Programme Intellectual Property in such indications or regions as are specified in the notice served by the [Funder] exercising the option consistent with the applicable sub-clause in Clause [x]. The terms of such exclusive licence to the relevant Programme Intellectual Property shall:

(i) be free of consideration in respect of sales of Product made on a Not-for-Profit Basis, and

(ii) include a share of any revenue or other consideration received by the [Funder] under any license of relevantProduct Intellectual Property with respect to all other sales, such share to be based on the respective contributions made by [Developer] and the [Funder] in the Development and Exploitation of such Product;

  • [Developer] will grant to the [Funder] or its nominee, a non-exclusive licence to relevant Background Intellectual Property solely as required and for the purposes of enabling the [Funder] to exercise the rights to the relevant ProgrammeIntellectual Property as described in (a) above and solely in the regions specified in the notice served by the [Funder]exercising the option. Any such licence grant shall be non-exclusive and free of charge other than for reasonable costs that are incurred in respect of necessary third-party licences; and
  • provide the [Funder] with access to any associated data, Documents (including, without limitation, Documents relating to pre-clincial data and clinical trials), pre-clinical data, Materials (only to the extent actually in existence and amenable to transfer in reasonable quantities without further regulatory approval(s), and not to include commercial inventory of Product for which [Developer] retains rights to Exploit), regulatory approvals, Marketing Approvals, information as required for the [Funder] to exploit such rights.

If the [Funder] exercises its right to exploit any Programme Intellectual Property under Clause [x] above, [Developer] agrees that it shall pass (or will procure that relevant members of the [Developer] Group shall pass) to the [Funder] immediately any or all exploitation opportunities in the applicable region(s) that it becomes aware of from time to time in connection with the Programme Intellectual Property. [Developer] further undertakes that it shall not (and that it shall procure that no member of the [Developer] Group shall) engage in any activities (including in relation to the Background Intellectual Property) that could reasonably lead to the loss of an exploitation opportunity in the applicable region and with respect to the applicable indication(s) without the prior written consent of the [Funder].

Source: Taken from a research funding agreement between the Wellcome Trust (Funder) and PTC Therapeutics (Developer) under the Trust’s Seeding Drug Discovery Strategic Award Programme for the discovery and development of a novel glioblastoma treatment. Read in context.

4. Survival of equitable access obligations

Sustainable access is also supported through partnering agreement provisions that address the impact of the potential acquisition of either the developer’s business as a whole or the intellectual property relevant to the funded product. This is done by requiring that the obligations attached to the project funding and product are transferred as part of an acquisition.

Examples from the MAPGuide:

 If control of the [Developer]’s Project IP Rights resulting from the Project changes, whether through sale, transfer, license, assignment or otherwise, the [Developer] will require the obligations of Sections [x] to follow the Product and be incorporated into any such sale, transfer, license, assignment or otherwise to the new [Developer] (the “Acquirer”). Prompt notice will be provided by the [Developer] to the [Funder] of any such event. If the Acquirer accepts obligations under Sections [x], the [Developer] is discharged from further obligations from Sections [x].

Source: taken from the template CARB-X (Funder) cost-reimbursement agreement with subrecipients (Developer) for the early stage development of antibiotics, vaccines, and rapid diagnostics against bacterial threats. Read in context.

 During the Term, [Developer] shall […] make no encumbrances over, dispose of, or otherwise deal with the Project Results, Project Intellectual Property and/or Enabling Rights in any way that could be reasonably deemed inconsistent with this Agreement, including the Public Health Licence, or that could impede the complete fulfillment of its obligations under this Agreement, without the express written permission of [Funder]. […]

In the event that the Public Health Licence becomes exercisable and irrespective of whether the Agreement has expired or been terminated, [Developer] shall make no encumbrances over, dispose of, or otherwise deal with the Project Results, Project Intellectual Property and/or Enabling Rights, in any way that may be inconsistent with the Public Health Licence, without the express written permission of [Funder].

Source: taken from an outbreak response agreement between CEPI (Funder) and Variation Biotechnologies Inc (Developer) for the development of COVID-19 vaccine candidates. Read in context.

 In the event [Developer], [Developer] assets necessary to perform [Developer]’s obligations hereunder are licensed to, transferred to, sold to or otherwise acquired by a third party, including as a result of a Change in Control (any such license, transfer, sale or acquisition, including a Change In Control, is referred to herein as a “Transfer”), [Developer] will ensure all such obligations are assumed by the licensee, purchaser, transferee, acquirer or successor in a written agreement reasonably acceptable to the [Funder]. [Developer] Will not grant to a third party any rights or enter into any arrangements that would prohibit, prevent or otherwise restrict [Developer] or any purchaser, transferee, acquirer, or successor of [Developer] assets or [Developer] from fulfilling its obligations hereunder. For clarity, notwithstanding anything to the contrary herein, the [Funder]’s rights hereunder which exist on the date of the Transfer shall not be terminated by such Transfer. A breach of this provision will constitute a Charitability Default.

Source: Taken from a global access commitments agreement between the Bill & Melinda Gates Foundation (Funder) and Novavax (Developer) for the development of an affordably-priced RSV vaccine for use in maternal immunization to provide RSV protection in low income countries. Read in context.

Except for rights granted in the Existing Agreements as of the Effective Date, the [Developer] will not grant to a third party any rights or enter into any arrangements or agreements that would limit or restrict the [Funder]’s rights related to the Global Access Commitments, including the [Funder]’s right during the Project Commencement Period to enter into Projects with the [Developer] with respect to any Target Diseases and Conditions. For the avoidance of doubt, nothing in this Agreement prohibits the [Developer] from entering into an agreement with a third party with respect to the development, manufacture and commercialization of a product for a Target Disease and Condition provided that such agreement does not limit or restrict the [Developer]’s ability to fulfill the Global Access Commitments, and the [Funder]’s consent will not be required for such an agreement. In order to confirm that CureVac’s agreements with third parties relating to any Target Disease and Condition do not limit or restrict the [Funder]’s rights, [Developer] agrees that it will include language substantially similar to the following in such agreements:

The [Developer] and [third party] acknowledge that the [Developer] and the [Funder] have entered into a Global Access Commitments Agreement (the “Global Access Agreement”) pursuant to which the [Developer] has agreed to work together with the [Funder] on vaccine and drug development for certain Target Diseases and Conditions pursuant to the terms of the Global Access Agreement and any subsequent agreements entered into by the [Developer] with respect to a particular project (each, a “Project Agreement”). The [Developer] and [third party]agree that this [third party agreement] shall be subject to the terms of the Global Access Agreement and in no way shall this [third party agreement] limit or restrict the [Funder]’s rights or the [Developer]’s obligations pursuant to the Global Access Agreement or any existing Project Agreement. The [Developer] and [third party] agree that the [Funder] is a third party beneficiary of this provision and will have the right to enforce this provision in order to protect the [Funder]’s Rights pursuant to the Global Access Agreement and any applicable Project Agreements. For the avoidance of doubt,unless otherwise agreed with the [third party], the [Funder] has no claims to the results generated and to the intellectual property rights and know how Controlled by [third party]; provided that nothing in this [third party agreement] will limit or restrict the Global Access Commitments.

In the event the [Developer] collaborates with a third party with respect to any Target Disease and Condition that becomes the subject matter of a Project hereunder, the [Funder] and the [Developer] will negotiate in good faith with such third party to attempt to combine the development efforts and align the respective project plans; provided that if the [Funder] and the third party cannot reach agreement, the [Funder] and the [Developer] can proceed with such Project in accordance with the terms of this Agreement and the applicable Project Agreement.

Survival of rights: As a condition of any acquisition of the Platform Technology or the [Developer]’s manufacturing facilities directly, or through a Change in Control, the Global Access Commitments described above will survive and be assumed by the acquirer to the extent required to carry out the Global Access Commitments, and the [Funder] shall have the right to review such provisions of the written agreement with such third party that relate to the assumption of the Global Access Commitments to confirm that the Global Access Commitments will survive and be assumed by the acquirer to the extent required to carry out the Global Access Commitments, and the [Developer] will not grant to a third-party any rights to, or enter into any arrangements with respect to, the Platform Technology or its manufacturing facilities to the extent such rights or arrangements would prevent the [Developer] (or any acquirer of the Platform Technology or manufacturing facilities) from fulfilling the above stated Global Access Commitments.

In order to confirm the Global Access Commitments will survive and be assumed by the acquirer, the [Developer] will add language substantially similar to the following to its acquisition agreements with third parties:

The [Developer] and [third party] acknowledge that the [Developer] and the [Funder] have entered into a Global Access Commitments Agreement (the “Global Access Agreement”) pursuant to which the [Developer] has agreed to certain Global Access Commitments pursuant to the terms of the Global Access Agreement and subsequent agreements entered into by the [Developer] with respect to particular projects (each, a “Project Agreement”)

[Third party] agrees that the Global Access Agreement will continue in full force and effect following consummation of the transactions contemplated by this [acquisition agreement] and [third party] will ensure performance of the terms of the Global Access Agreement and that in no way shall this [third party agreement] limit or restrict the [Funder]’s rights or the [Developer]’s obligations pursuant to the Global Access Agreement or any existing Project Agreement. The [Developer] and [third party] agree that the [Funder] is a third party beneficiary of this [third party agreement] with respect to the Global Access Commitments and will have the right to enforce this provision in order to protect the [Funder]’s rights pursuant to the Global Access Agreement and any applicable Project Agreements.

Source: taken from a development funding agreement between the Bill & Melinda Gates Foundation (Funder) and CureVac (Developer) in relation to the Foundation’s investment in Series B shares in CureVac. The investment is to be used solely to fund a new manufacturing facility which can be used to manufacture vaccines and drugs in support of the Foundation’s equitable access objectives, or to continue development and use of CureVac’s mRNA platform technology to advance drug and vaccine candidates in support of the equitable access objectives. Read in context.

Related Commentaries

The inclusion of access licenses in a funding agreement should be considered as part of a broader IP management plan for the partnership.

Sustainability provisions need to be supported by dispute resolution and termination provisions that provide a funder with rights to discontinue funding with a developer but do not release the developer from all of their obligations (for example, fulfilling requirements under an access license).

Authors: Bridie Telford, Julia Barnes-Weise

First publication date: November 21, 2022