MAPGuideⓇ
Equitable Access Toolkit

Enforcement and Continuity Mechanisms in R&D Funding Agreements

Enforcement and continuity provisions are mechanisms for mitigating potential risks to the achievement of the access objectives for an agreement, as well as for extending opportunities for achieving access beyond the scope or term of an individual agreement.

Some common types of enforcement and continuity provisions in funding agreements are:

Duration of commitments

Requirements for the funded partner to continue fulfilling access commitments for a certain period of time after the end of an agreement.

Pass through of commitments

Requirements for the funded partner’s access commitments to flow through to development, manufacturing, and commercialization partners.

Transfer of commitments

Requirements for access obligations to remain attached to the funded product or IP if they are acquired by a third party.

Further funding rights

Rights for the funder to provide further funding of product development and commercialization activities beyond the scope of the existing funding agreement.

Access licenses

Provisions that grant rights to a funder and/or third party to use project-related IP rights for certain purposes if the funded partner is unwilling or unable to meet its access obligations.

Termination rights

Provisions establishing the funder’s right to terminate the agreement, the consequences of termination, and the obligations that survive termination.

A further consideration for funders is to include a right to share details of the access commitments in the agreement with relevant third parties – for example, other funders or market-shaping organizations that may have a role in later-stage development and commercialization activities. Enabling this level of transparency may support the continuity and greater alignment of activities to facilitate end-to-end access.

Pass through of access commitments

Funded partners often enter into agreements with third parties to support the development and/or commercialization of a funded product or technology. These agreements often take the form of sub-awards or sub-grants under which the development/commercialization partner is responsible for undertaking certain activities within the scope of the funded project such as conducting clinical trials or product manufacturing.

To ensure the continuity of access obligations across the parties involved in the development and commercialization of a funded product, funding agreements may include a requirement for the funded partner to secure binding and enforceable access commitments in applicable agreements with third parties.

Examples from the MAPGuide

During the Commitment Period, the [Developer] will include the following binding commitment, using language substantially similar to the following, in each purchase and/or supply agreement with a Purchaser for the purchase of the [Developer]’s AA or AD that will be converted into artemisinin and included into ACTs:

“[Purchaser] agrees that it (i) will sell artemisinin and/or ACTs produced using any of the AA or AD produced by the [Developer] at a price that is affordable for public sector purchasers of ACTs such as the Global Fund to Fight AIDS, TB and Malaria or the President’s Malaria Initiative and (ii) will take into account any savings in the cost of its production resulting from the lower price of AA or AD produced by the [Developer] when setting the price of its artemisinin and/or ACTs.”

The [Developer] will take reasonably necessary steps to ensure that its Purchasers comply with such binding commitments.

The [Developer] and the [Funder] acknowledge that the intent of the foregoing provision is to try to ensure that any cost savings in the price of AA or AD produced by the [Developer] relative to AA or AD market prices as of the date of this Letter Agreement will result in a lower cost of artemisinin and/or ACTs for end users, and the [Developer] and the [Funder] will cooperate in good faith during the Commitment Period to modify these provisions as needed to best achieve this objective.

Related definitions: “Purchasers” – companies qualified to convert AA or AD to artemisinin for anti-malarial uses and/or that produce ACTs that meet applicable WHO standards.

Source: taken from a letter agreement between the Gates Foundation (Funder) and Amyris (Developer) signed in connection with a USD $5 million stock purchase by the Gates Foundation. Partner types: philanthropic funder, industry; Product type: input material for malaria therapeutics (artemisinic acid and amorphadiene for use in artemisinin-based combination therapies (ACTs)); Development stage at signature: licensed product. Read in context.

The [Developer] will ensure that it secures appropriate commitments from all Commercialisation Partners and includes appropriate terms and conditions in all Commercialisation Agreements in order to ensure compliance with the Access Commitments. Such commitments, terms and conditions will require that Commercialisation Partners (as relevant and appropriate): (i) legally commit to and comply with the Access Commitments; and (ii) agree that compliance with the Access Commitments will be subject to audit by an independent firm of accountants at any time. The result of the audit will be binding, and such Commercialisation Partner should agree to implement any adjustments which are necessary as a result of the audit.

Source: taken from the sample terms and conditions for Unitaid (Funder) funding for Recipients (Developer) under the UnitaidExplore program. Partner types: non-profit funder, industry; Product type: innovations with transformative potential for public health in LMICs; Development stage at signature: multiple. Read in context.

A Sub-Awardee must agree to comply with all of the relevant obligations applicable to Awardee, whether explicitly identified as such or as is reasonable from the nature of the obligation. Each sub-agreement with a Sub-Awardee must: […] be consistent with the obligations in the sections related to Dissemination and Publication of Project Data (Clause [x]); Dissemination of Project Materials (Clause [x]); Intellectual Property (Clause [x]); Equitable Access (Clause [x]); Sharing of Commercial Benefits (Clause [x]); Preparation for Outbreaks (Clause [x]); the Public Health License (Clause [x]); and Term and Termination (Clause [x]).

Source: taken from CEPI’s (Funder) template funding agreement for its CfP3(i) funding call, supported by the European Commission’s Horizon 2020 programme. Partner types: non-profit funder; Product type: Rift Valley Fever and Chikungunya vaccines; Development stage at signature: early- through to late-stage clinical development. Read in context.

Transfer of access commitments

Funding agreements may need to include provisions to address the risk of the funded partner’s business as a whole, or the intellectual property related to the funded product being acquired by or otherwise transferred to a third party. Situations in which this risk may arise may include the acquisition of a small biotech by a larger company, or assignment or sale of IP rights if a company decides to divest a part of its business.

Agreement provisions can provide for the continuity of access obligations in such scenarios by requiring that the obligations are incorporated into the terms of the sale or transfer of any IP rights or other assets that are required to fulfil the access commitments. Some agreements also include a right for the funder to review the relevant provisions of the sale or transfer agreement to confirm that the access obligations will be assumed by the third party.

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 CARB-X template funding agreement. Partner types: non-profit funder, industry/academic institution/PDP; Product type: antibacterial products (antibiotics, preventatives, rapid diagnostics); Development stage at signature: discovery through to phase 1 clinical trial. Read in context.

In the event [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 Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.

In the event of the assignment, sale, exclusive license, or other transfer of the Global Access Products, and/or related technology, the Global Access Commitments shall survive and the [Developer] shall ensure that the Global Access Commitments are assumed by the purchaser, transferee, licensee, or acquirer. [Funder] shall have the right to review the 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 third party. The [Developer] shall not grant to a third party any rights or enter into any arrangements, amendments, or agreements that would limit or restrict [Funder]’s rights to enforce the Global Access Commitments or the [Developer]’s obligations to satisfy the Global Access Commitments, unless such third party expressly assumes such Global Access Commitments to the satisfaction of [Funder].

Source: taken from a global health agreement between Adjuvant Global Health Technology Fund (Funder) and AN2 Therapeutics (Developer) signed in connection with a USD $7 million share purchase by Adjvant. Partner types: impact investor, industry; Product type: melioidosis and tuberculosis therapeutic (Epetraborole); Development stage at signature: preclinical. Read in context.

Further funding rights

The scope of a single funding agreement often does not provide funding for all stages of the product development process from early-stage R&D through to commercialization. Instead, funding agreement scope is often limited to a subset of activities, for example drug discovery work, pre-clinical studies, or a certain stage of clinical trials.

This limited scope of funding may impact the types and duration of access commitments that a funder is able to negotiate as part of the funding agreement. Some funding agreements mitigate this challenge through a right for the funder to fund follow-on development and commercialization work for the product or technology, thereby providing an opportunity to negotiate more detailed or expanded access commitments.

These provisions are sometimes described as a “first right” or “first option” for further funding, and may also include a requirement for the funded partner to notify the funder of offers of funding from a third party. The exercise of the right or option is usually at the funder’s discretion, and is subject to the good faith negotiation of related agreement terms between the parties (either as a separate agreement or amendment to an existing agreement).

Examples from the MAPGuide

[Funder] shall have the first right […] in its sole discretion, to provide further funding and other support for the further development, manufacture and deployment of the Product in Non-Traveler’s Market countries. Such activities would be negotiated in good faith and set out in an additional Work Package(s) with associated project budget for such additional Work Packages amending Annex [x]. Nothing in this Clause [x] confers any obligation on [Funder] to fund additional Work Packages.
[…]
in the event that (a) awardee reasonably requires any third party funding for the development, manufacture or deployment of the Product in Non-Traveler’s Market countries; or (b) Awardee receives any offer or indication of interest from a third party, or identifies a call for proposal from a third party, to provide funding support for such development, manufacture or deployment, Awardee shall provide prompt written notice to [Funder], including a summary of the amount of funding required or offered and the terms (if any) offered by any potential third party funder (each a “Further Funding Notice”). [Funder] shall provide written notice to Awardee that it does, or does not wish to provide such further funding within [***] of receipt by [Funder] of a Further Funding Notice. After this period Awardee shall have the right to accept any third party funding support for the development, manufacture and deployment of the Product in Non Traveler’s Market countries provided [Funder] (i) notifies Awardee that it does not wish to provide additional funding, or (ii) fails to provide Awardee with such notice within the [***] time period.

Source: taken from a USD $41.3 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: licensed product. Read in context.

After [Developer] has completed the initial scope of work […], the [Funder] will have the right, at its sole discretion, to provide grant funding (directly or through a [Funder]-supported Entity) to advance the [Products] through development, manufacturing,commercialization and distribution of a final product in accordance with the applicable TPP, in accordance with Section [x] below, provided that any such additional grant funding will be in the [Funder]’s discretion and subject to execution of grant documents for such projects in accordance with the [Funder]’s standard grantmaking process.

[…]

Following completion of the initial scope of work […], if the [Funder] requests [Developer] to conduct further development, modifications, or clinical trials with respect to the [Products], [Developer] will negotiate in good faith with the [Funder] or a [Funder]-Supported Entity designated by the [Funder] to reach agreement upon a project plan, which may include work to be undertaken, responsibilities, participation by other parties, timelines and milestones, project management, contributions in-kind and funding requirements, a commercialization plan, and any additional Global Access commitments. The specific level of funding responsibilities for the additional work will be mutually agreed in good faith in a written agreement between the parties. […] The [Funder] will have the right, at its sole and absolute discretion, to continue providing funding (directly or through a Foundation-supported Entity) to advance the Antiviral Products through to product launch of a final product for the purpose of enabling Global Access. For the avoidance of doubt, if the [Funder] elects to proceed with further development it will provide additional funding as described herein.

Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Exscientia (Developer) signed in connection with a USD $35 million investment by the Gates Foundation. Partner types: philanthropic funder, industry; Product type: anti-infective therapeutics for future pandemic preparedness; Development stage at signature: discovery.

Access licenses

The term “access licenses” is used here to describe a mechanism included in an R&D funding agreement to enable the continued development and/or commercialization of a funded product or technology for the purpose of achieving equitable access in the event that the funded partner is unable or unwilling to fulfil its obligations.

A number of R&D funders have developed their own terminology to describe these mechanisms, 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).

The specific conditions of an access license vary depending on the context of a particular agreement. Some of the factors used to establish when and how a funder can exercise an access license are outlined below.

License triggers

Some access licenses may be exercised by the funder at any point after execution of the funding agreement. However, the exercise of access licenses is often conditional on the occurrence of a trigger event (sometimes referred to as a “condition precedent”), for example, if the funded partner:

    • 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 agreement;
    • Makes a strategic decision to discontinue development of the product; and/or
    • Declines to undertake additional activities to respond to a health emergency.

Access licenses may also be triggered as a consequence of agreement termination in certain circumstances.

Some agreements 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. They may also include a mechanism for the funded partner to demonstrate that global access can be achieved without the funder’s exercise of an access license.

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 the agreement, for example for supply only to a specific territory, rather than making commercial sales of the product in high-income markets.

Identification of alternative developers/manufacturers

While some access licenses provide for a funder to take over the project activities directly, another common approach is for project-related development and manufacturing rights to be granted to a new development and commercialization partner. Some agreements provide for the advance selection of a “Trusted Collaborator” or “Trusted Manufacturer” who could take on this role. This approach 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, manufacturing or commercialization activities themselves.

Actions required upon exercise of the license

Funding agreements often set out specific actions to be taken by the funded partner in the event that the funder exercises an access license. These may 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, including rights of reference to regulatory filings; and
    • Passing through opportunities for exploitation of the licensed intellectual property rights.

Examples from the MAPGuide

License triggers

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: Gates Foundation standard grant terms & conditions. Partner types: philanthropic funder, industry/academic institution; Product type: multiple; Development stage at signature: multiple. Read in context.

“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 [agreement];
  • commits a material breach of term of the Grant Agreement or this [agreement];
  • 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 [agreement]; 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 [agreement] 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 [x]. 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].

Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. 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 CARB-X template funding agreement. The Funder receiving the Access License is the Wellcome Trust, a funder of CARB-X. Partner types: non-profit funder, industry/academic institution/PDP; Product type: antibacterial products (antibiotics, preventatives, rapid diagnostics); Development stage at signature: discovery through to phase 1 clinical trial. 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 [x] 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 USD $34 million funding agreement between CEPI (Funder) and CureVac (Developer). Partner types: philanthropic funder, industry; Product type: mRNA platform technology; Development stage at signature: preclinical. 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 USD $5.4 million grant agreement between the Wellcome Trust (Funder) and PTC Therapeutics (Developer). Partner types: philanthropic funder, industry; Product type: cancer therapeutic; Development stage at signature: drug discovery. Read in context.

The Global Health License is a present license but the Investor will not exercise their rights under such license except in the event of a License Trigger Event as defined below.

A License Trigger Event means:

(1) the [Developer] fails to use commercially reasonable efforts to obtain regulatory approvals, as agreed by the Global Access Committee;

(2) the [Developer] fails to cure an Event of Non–Compliance, including a failure to perform the Global Access Commitments, within the applicable time period (it being understood that the exercise of the Investor’s rights under the Global Health License, and the Investor’s rights to transfer its Shares under the terms of the side letter between the [Developer], the Investor and certain other individuals named therein, dated as of even date herewith, shall be its sole and exclusive remedies following the [Developer]’s failure to cure an Event of Non–Compliance);

(3) the [Developer] or any transferee assigns or transfers (including by exclusive license) any material intellectual property to the Products or other intellectual property subject to the Global Access Commitments and the successor fails to assume or perform the relevant Global Access Commitments; or

(4) the [Developer] or any transferee (1) institutes any bankruptcy, insolvency, reorganization, arrangement, readjustment of debt, dissolution, liquidation, assignment for the benefit of creditors, or similar proceeding relating to it under the laws of any jurisdiction or any such proceeding is instituted against the [Developer] or any transferee that remains undismissed or unstayed for a period of 90 days, or (2) ceases to conduct business in the ordinary course or is determined to no longer be a going concern. Notwithstanding the foregoing, a License Trigger Event will not be deemed to have occurred if the [Developer] or its transferee voluntarily or involuntarily files a Chapter 7 liquidation proceeding that is converted to a reorganization proceeding within 60 days after filing; provided, that the [Developer] or its transferee continues to perform its Global Access Commitments.

Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) signed in connection with a USD $4 million preferred stock purchase agreement. Partner types: impact investor, industry; Product type: allergic rhinitis therapeutic & diagnostic; Development stage at signature: early stage development. Read in context.

In the event that the [Developer] intends to enter into an agreement with a major biopharmaceutical [Developer] (as defined above), with a demonstrable corporate commitment to serving patients in Developing Countries and a clear written plan for achieving the Global Access Objectives, for the development and commercialization of products in one or more [Funder] Priority Areas in a manner consistent with the Global Access Objectives, upon written request of the [Developer], the [Funder] shall relinquish its non-exclusive rights in the applicable [Funder] Priority Area(s). The [Developer] shall provide the [Funder] with the applicable provisions of the agreement with such third party relating to the Global Access Objectives and shall consider in good faith suggestions from the [Funder] relating to such agreement. Moreover, the [Developer] shall report (or cause such third party to report) to the [Funder] on a semi-annual basis regarding the progress of the [Developer] and such third party in connection with the Global Access Objectives in such [Funder] Priority Area(s). If the [Funder] believes that the Global Access Objectives are not being met, it shall provide notice to the [Developer], and the [Funder], the [Developer] and such third party shall meet to discuss the issues raised by the [Funder] and such parties shall develop, acting in good faith, a written plan to resolve such issues. The non-exclusive rights in the applicable [Funder] Priority Area(s) specified in this section shall be considered to be in force in favor of the [Funder] if and when the agreement between the [Developer] and such major biopharmaceutical [Developer] is terminated.

Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and Visterra (Developer) made in connection with a USD $6.8 million Series A preferred stock investment. Partner types: philanthropic funder, industry; Product type: platform technology, vaccines, therapeutics; Development stage at signature: early stage development. Read in context.

Scope of access license

Public Health License 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 USD $23.4 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: phase 3 clinical trials. 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. […] 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 global access commitments agreement between the Gates Foundation (Funder) and CureVac (Developer) signed in relation to an investment in CureVac by the Foundation. Partner types: philanthropic funder, industry; Product type: vaccines and drugs for target diseases using mRNA platform technology; Development stage at signature: preclinical. Read in context.

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 Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.

Identification of alternative developers/manufacturers

Subject to the undertakings to be defined in the Additional Work Packages and – upon Partner’s request, subject to a separate confidentiality agreement to be concluded between the Partner and the Trusted Manufacturer – the Partner will support [Funder] in appointing one or more Trusted Manufacturers that are technically and operationally capable of and willing to rapidly Manufacture Product for use in the Field in the Affected Territory on an ongoing basis both during and after completion of the Project, in accordance with [Funder]’s requirements, as set forth herein.
Subject to the undertakings in the Additional Work Packages the Partner shall:
(i) grant appointed Trusted Manufacturers all necessary rights to use (on a non-exclusive, royalty-free and license-fee free basis) the Background Technology and Project Technology to further Develop the Platform, and to Manufacture Products for use in the Field in the Affected Territory in accordance with the [Funder] Production Timescale and in the quantities reasonably likely to be necessary in the event of an Outbreak or risk of Outbreak in the Field and at a cost of goods in line with the methodology to determine pricing obligations set out in the [Funder] Equitable Access Policy;

Related definitions:

  • “Additional Work Package” means a Work Package of work under the Project to be agreed between the Parties from time to time in addition to those agreed upon on the Effective Date, and funded by [Funder] which may be related to Products.
  • “Trusted Manufacturer” means a Third Party nominated by the Partner and appointed by [Funder], or nominated by [Funder] and appointed by the Partner if so agreed in Additional Work Package Statements.

Source: taken from a USD $34 million funding agreement between CEPI (Funder) and CureVac (Developer). Partner types: philanthropic funder, industry; Product type: mRNA platform technology; Development stage at signature: preclinical. 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 for up to USD $384 million between CEPI (Funder) and Novavax (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: phase I clinical trials. Read in context. 

Actions required upon exercise of the license

In connection with the exercise of any license hereunder or under a grant agreement (as applicable), the [Developer] 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 [Funder], the [Funder]’s sublicensees, and/or the relevant [Funder] 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 Gates Foundation (Funder) and Arsanis (Developer) signed in connection with an USD $8 million investment by the Foundation. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb (staphylococcus aureus); Development stage at signature: discovery. 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 for up to USD $384 million between CEPI (Funder) and Novavax (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: phase I clinical trials. Read in context. 

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

(a) [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;

(b) [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 Programme Intellectual 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

(c) 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 USD $5.4 million grant agreement between the Wellcome Trust (Funder) and PTC Therapeutics (Developer). Partner types: philanthropic funder, industry; Product type: cancer therapeutic; Development stage at signature: drug discovery. Read in context.

(i) In connection with any Global Access License hereunder, such Global Access License shall be subject to the execution of the following reasonably acceptable written agreements between the [Developer] and the recipient of the technology transfer (which recipient may be a [Funder] sub-licensee or entities selected by the [Funder]): quality agreement, safety data exchange agreement, and other customary agreements related to technology transfer of the Product; provided always that such entity shall not be required to pay any royalties, milestones or fees associated with such agreements. [Developer] will cooperate with the [Funder] in good faith to make available to the [Funder] (or the entities of the [Funder]’s choosing) (including providing electronic copies), all necessary intellectual property, technology, know-how and other information relating to the Product (including but not limited to master batch records, SOPs, QA/QC information, detailed bill of materials for the Product and other manufacturing documentation) for the purpose of permitting the [Funder] (or its selected entities) to utilize its Global Access License and to continue to research and develop and manufacture the Product, and to enable the manufacture, licensure, sale, offer-for-sale, import, export, distribution, and use of such Product intended for use in the Developing Countries.

For the purpose of facilitating Technology Transfer the [Developer] shall provide electronic copies of all such applicable records and manufacturing documentation related to the Product for Maternal Immunization and the [Funder] (or the entities of the [Funder]’s choosing) and will be permitted to inspect the same for the purpose of assuring complete and accurate technology transfer by [Developer].

(ii) [Developer] will continue to meet its Global Access Commitments towards and until completion of all intellectual property, know-how and information technology transfer associated with a Global Access License herein. [Developer] and the [Funder] will cooperate in good faith to effect an orderly and complete transition of any activities, including the research, development, manufacture, licensure, sale, offer-for-sale, distribution, import, export and use of the Product to the [Funder] or its selected entities.

(iii) [Developer] shall permit the [Funder] (or its sublicenses) the right to access and cross-reference any applicable IND, BLA, WHOPQ or other regulatory file relating to the Product and shall, upon request, provide an electronic copy of each such file.

(iv) To the extent applicable, the Parties further agree to take all reasonable and diligent steps to eliminate or reduce any third party costs or royalties (set forth in Appendix [x] or otherwise attributable to the Product) associated with such Global Access License, including negotiation of any third party royalties and to negotiate access to such third party licenses by the [Funder] (or its selected entities).

Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.

Termination rights

It is important for funding agreements to establish both the circumstances under which a party may choose to terminate the agreement, and the rights and obligations of each party in the event of termination. These termination rights can help to protect public and philanthropic funds from misuse or inefficient use, as well as ensuring that there is a pathway to secure continued access to funded IP and project results for future use in support of equitable access objectives.

Grounds for termination

Grounds for agreement termination that are common across a broad range of agreements include material breach, bankruptcy or insolvency proceedings, force majeure, fraud, and changes in ownership or control. Additional grounds for termination that may be considered specifically in relation to risks to the achievement of the equitable access objectives for a funded project may include:

    • Technical- or cost-related product development challenges impacting the suitability of the product for use in the access territory. For example, inability to meet minimum TPP criteria or a target cost of goods;
    • Failure by the funded partner to meet specific access obligations such as responding to public tenders, complying with a maximum price requirement, or cooperating with public health emergency response; or
    • Changes in the funded partner’s business strategy or leadership that are likely to impact on the partner’s willingness or ability to remain aligned with the equitable access objectives of the agreement.

Effects of termination

Some common effects of termination across a range of agreements include the destruction or return of confidential information, fulfilment of obligations accrued before the effective date (e.g., making payments due), and the survival of certain provisions beyond the end of the agreement.

In addition to these general requirements, effects of termination provisions can include rights and obligations intended to enable continued progress towards equitable access objectives. These provisions may only apply in certain termination circumstances, particularly where the termination is due to the funded partner’s default or breach of its obligations. Access-related effects of termination provisions may include:

    • A right for the funder to exercise an access license;
    • Assignment of funded IP from the funded partner to the funder (or a party nominated by the funder);
    • Continued data sharing and publication obligations for the funded partner;
    • Continued commercial benefit sharing obligations for the funded partner;
    • Survival of access-related obligations;
    • Transfer of data, documents and materials, including regulatory approvals, required by the funder to exercise its termination rights (including an access license);
    • Assignment or novation of third party contracts related to the development or commercialization of the funded product to the funder;
    • Technology transfer from the funded partner to a third party manufacturer;
    • Responsible and ethical wind-down of any ongoing clinical trials; and/or
    • Cooperation from the funded partner in a project hand over.

Examples from the MAPGuide

Grounds for termination

The [Funder] may modify, suspend, or discontinue any payment of Grant Funds or terminate this Agreement if: (a) the [Funder] is not reasonably satisfied with [Developer’s] progress on the Project; (b) there are significant changes to [Developer’s] leadership or other factors that the [Funder] reasonably believes may threaten the Project’s success; (c) there is a change in [Developer’s] control; (d) there is a change in [Developer’s] tax status; or (e) [Developer] fail to comply with this Agreement.

Source: taken from a USD $9.3 million grant agreement between the Gates Foundation (Funder) and Arsanis (Developer). Partner types: philanthropic funder, industry; Product type: RSV mAb; Development stage at signature: pre-clinical. Read in context.

The Withdrawal Right described and defined in this Section [x] will be triggered only as a result of a Charitability Default.

A “Charitability Default” will occur if the Company (i) is in material breach of any of the Global Access Commitments, including the material failure to conduct the Programs as described above, other than for reasons of regulatory, technical or scientific failure not within the reasonable control of the Company and not known to the Company at or before closing of the [Funder] Investment, (ii) fails to comply with the restrictions […] on the use of proceeds from the [Funder] Investment, or (iii) fails to comply with the other related U.S. legal obligations set forth in this Letter Agreement […]. Each party agrees to promptly notify the other party in writing if it becomes aware of a Charitability Default and the Company will thereafter promptly provide to the [Funder] a proposed strategy to remedy the Charitability Default. Notwithstanding the foregoing, the [Funder] will not lose any rights or remedies solely as a result of a failure to notify the Company after it becomes aware of a Charitability Default.

Source: taken from a strategic relationship agreement between the Gates Foundation (Funder) and Arsanis (Developer) signed in connection with an USD $8 million investment by the Foundation. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb (staphylococcus aureus); Development stage at signature: discovery. Read in context.

[Funder] shall be entitled to terminate this Agreement by notice in writing to [Developer], such termination to take effect as specified in the notice, if:

  • […]
  • [Developer] ceases or threatens to cease to carry on all or a substantial part of its business or operations necessary for the completion of its obligations under this Agreement;
  • [Developer] takes any action, or omits to take any action, the consequences of which, in the reasonable opinion of [Funder], would be incompatible with or have an adverse effect: (i) on [Funder]’s charitable objectives or reputation; or (ii) on the ability of [Developer] to comply with its respective obligations under this Agreement; and/or
  • [Developer] enters into transactions involving any of the Programme Intellectual Property and/or Background Intellectual Property without the prior written consent of [Funder], including, without limitation, assigning or otherwise transferring any Programme Intellectual Property or Background Intellectual Property or any interest in such Intellectual Property to an Affiliate or Third Party and/or creating any new security or increasing any existing security over any of the Programme Intellectual Property and/or Background Intellectual Property (other than netting or set–off arrangements entered into in the ordinary course of [Developer]’s banking or financing arrangements for the purpose of netting debit and credit balances; or any lien arising by operation of law and in the ordinary course of business).

[…]

In the event that [Developer] undergoes a Change of Control, [Developer] shall give [Funder] prompt notice of such Change of Control.

  • During the Programme Term, if in [Funder]’s reasonable opinion, the Change of Control would have an adverse effect on, or be incompatible with [Funder]’s charitable objectives or [Developer]’s ability to fulfil its obligations under the Agreement, [Funder] may in its absolute discretion, terminate the Agreement by serving written notice of termination on [Developer].
  • Following the Programme Term, the surviving entity following such Change of Control shall, within [**] days of such Change of Control, confirm in writing to Trust its intentions to continue to meet its obligations under this Agreement, and meet with Trust to present its plans for Exploiting the Programme Intellectual Property and commercializing Products. […]

Source: taken from a USD $5.4 million grant agreement between the Wellcome Trust (Funder) and PTC Therapeutics (Developer). Partner types: philanthropic funder, industry; Product type: cancer therapeutic; Development stage at signature: drug discovery. Read in context.

[Funder] will evaluate whether individual Milestones have been met on an on-going basis. If an individual Milestone is not met by the agreed date […], [Funder] may either:

(a) amend the Milestone in agreement with the [Developer], provided that:

(i) either (A) the Company Support Team together with the Post-Award Advisory Board Chair or (B) the Post-Award Advisory Board, advises that this is appropriate; and

(ii) the amended Milestone still delivers the agreed objectives of the current work segment; or

(b) cease funding activities under the Agreement, in accordance with termination provisions identified in Section [x].

Source: taken from the CARB-X template funding agreement. Partner types: non-profit funder, industry/academic institution/PDP; Product type: antibacterial products (antibiotics, preventatives, rapid diagnostics); Development stage at signature: discovery through to phase 1 clinical trial. Read in context.

[I]f the progress of the Project varies substantially from the objectives set out in the Proposal this may amount to a breach of this Agreement and [Funder] reserves the right to withdraw the Grant. If [Funder] decides to withdraw the Grant, the [Developer] will be given 28 days to appeal before the Grant is terminated.

Source: taken from the standard grant terms and conditions for GOSH Charity (Funder). Partner types: philanthropic funder, academic institution, non-profit research institution; Product type: products for prevention, diagnosis, prognosis, or treatment of rare or complex paediatric diseases; Development stage at signature: early stage R&D. Read in context.

Effects of termination

Obligations On Termination By [Funder] Pursuant To Clauses [x] (Termination For Default; [Funder]’s Reasonable Determination that Awardee is or will be Unable to Perform; Financial Irregularity; or Failure to Satisfy [payment conditions], respectively)

Solely at [Funder]’s discretion, [Funder] may reimburse Awardee for some or all of Awardee’s reasonably incurred non-cancellable expenses relating to the Project which were authorised by [Funder] and which arise after the termination date.

Subject to Clause [data sharing], Awardee shall promptly make all Project Data publicly available in such manner as [Funder] may direct, save to the extent that to do so would result in the public disclosure of Enabling Technology which would not otherwise be publicly disclosed.

[Funder] shall have the right to require Awardee, at [Funder]’s discretion, to either: (i) perform Technology Transfer to a Trusted Collaborator […] on an expedited basis at the Awardee’s cost, or (ii) if Technology Transfer has already occurred at the date of termination and certain costs in relation to such Technology Transfer were borne by [Funder], reimburse [Funder] for such costs.

[Funder] shall have the right to exercise the Public Health License, pursuant to Clause [x].

Awardee shall use all reasonable endeavours to promptly transfer to [Funder] (or its nominee), at Awardee’s cost, any regulatory approvals and applications for regulatory approvals relating to the Product.

Awardee shall ship to [Funder] (or its nominee) all Project Materials within [***] of [Funder] requesting such Materials.

Awardee shall provide [Funder] with a list of all sub-license, contract manufacturing agreements and other agreements and arrangement to which Awardee is a party which relate to the development and marketing of the Product (the “Contracts“), within [***] of the Termination Date. [Funder] may request copies of any Contracts, which Awardee will promptly provide.

[Funder] shall have the right to require Awardee to: (i) assign the benefit (subject to the assumption of the burden) of one or more Contracts to [Funder] or its nominee and, where consent of a third party is required, seek to obtain such consent; (ii) novate one or more Contracts to [Funder] or its nominee; or (iii) terminate one or more Contracts in accordance with its terms at Awardee’s cost.

Source: taken from a USD $41.3 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: licensed product. Read in context.

On termination of this Agreement by [Funder] in accordance with Clauses [x]; [Developer] shall, so far as it is able to do so without violating legal requirements or breaching contractual obligations that existed prior to the event giving grounds for termination:

  • for no consideration assign all of its rights in the Programme Intellectual Property to [Funder] or a Third Party nominated by [Funder];
  • for no consideration procure that any licences of Programme Intellectual Property granted to [Funder] shall be assigned to [Funder] or a Third Party nominated by [Funder] or sub–licensed to [Funder] or a Third Party nominated by [Funder] on a world–wide, perpetual basis. Such sub-licenses shall be: (a) non–exclusive to complete the Programme and exclusive in relation to Development and Exploitation; and (b) free of charge and royalty free.
  • upon request from [Funder] and at no charge to [Funder], provide such assistance to [Funder] as [Funder] may reasonably require to assist in the assignment or sub–licensing of the rights in the Programme Intellectual Property or any licences pursuant to this Clause [x] and/or in the closure of the Programme;
    upon request from [Funder]:
  • grant to [Funder] as requested by [Funder] a world–wide, royalty free, perpetual, non–exclusive licence to use any and all of the [Developer] Background Intellectual Property owned or sub-licensable by [Funder] or any member of the [Funder] Group and required for further research in accordance with the Programme and/or Development and Exploitation of Programme Intellectual Property; and
    discuss in good faith a worldwide, non–exclusive licence to use any and all of the [Developer] Background Intellectual Property owned or sub-licensable by [Developer] or any member of the [Developer] Group for additional research, Development and Exploitation;
  • provide to [Funder] with all laboratory notebooks and other records relating to the Programme Intellectual Property and the Programme Books and Records;
  • as requested by [Funder], carry out a hand over of the Programme to [Funder] or wind down the Programme for a reasonable period of time, such period not to exceed [**] months following termination; and
  • return all equipment acquired by [Developer] using [Funder] Award.

Source: taken from a USD $5.4 million grant agreement between the Wellcome Trust (Funder) and PTC Therapeutics (Developer). Partner types: philanthropic funder, industry; Product type: cancer therapeutic; Development stage at signature: drug discovery. Read in context.

Related Considerations
IP rights management

How do rights related to access licenses interact with other licensing and technology transfer obligations under the agreement? How will the parties identify the IP rights falling within the scope of continuity and enforcement obligations?

Dispute resolution

What are the mechanisms for resolving disagreements regarding the funded partner’s fulfilment of its access obligations and/or exercise of an access license?

Reporting & audit

Will the reporting requirements under the agreement provide the funder with sufficient information to monitor the funded partner’s compliance with access obligations?

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This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.