MAPGuideⓇ
Equitable Access Toolkit
Enforcement and Continuity Mechanisms in License Agreements
Continuity and enforcement provisions are mechanisms to mitigate potential risks to the achievement of the access objectives for an agreement. These risks may arise if a licensee becomes unable or unwilling to fulfil its obligations under the agreement, or if development and commercialization responsibilities for the licensed product or technology are transferred to new partners over time.
Continuity and enforcement mechanisms in license and collaboration agreements can include:
Requirements for access commitments to be passed through to future development and commercialization partners as part of the terms of a sublicense agreement.
Provisions anticipating potential further collaboration between the parties if early stage R&D is successful.
Provisions that permit the licensor/collaboration partner or a third party to use licensed IP for the purposes of facilitating equitable access, even if the licensee has exclusive rights under the scope of the license agreement.
A right for the licensor to terminate some or all of the licensed rights if the licensee does not meet its access commitments.
A further consideration for agreements to include a right for the parties to share details of the access commitments under the agreement with relevant third parties – for example, funders, manufacturers, 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
Licensed rights are often sublicensed to new product development and commercialization partners as product development progresses. For example, the licensed rights under an early-stage, upstream license or collaboration agreement, are likely to be sublicensed to a downstream development partner, and potentially sublicensed through a further tier (i.e., sub-sub-licensed) to a manufacturer.
To ensure the continuity of access obligations across the parties involved in the development and commercialization of a product, license and collaboration agreements may include a requirement for the licensee to pass-through access commitments in any agreements that include the grant of a sublicense.
Examples from the MAPGuide
Partner may grant sublicenses to Third Parties under the licenses granted herein, subject to each such sub–licensee undertaking in writing to assume Partner’s obligation herein to commercialize the Product in the Field on an Affordable Basis in the Territory.
Source: taken from DNDi’s template Development Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from Phase 1 clinical trials through to proof of concept in humans. Read in context.
[Licensee] shall use reasonable efforts to either (I) obtain the commitment of its Sublicensees to use diligent efforts to develop and commercialize Licensed Products and Licensed Processes in Developing Countries in a manner that is designed to enable availability and accessibility at reasonable cost, or (II) retain rights to develop and commercialize Licensed Products and Licensed Processes in Developing Countries.
Source: Taken from an exclusive license agreement between M.I.T. (Licensor) and Visterra (Licensee). Partner types: academic institution, industry; Product type: dengue monoclonal antibodies; Development stage at signature: pre-clinical. Read in context.
Each Sublicense Agreement will include an agreed Commercialization plan (the Sublicense Access Plan), including specific target dates for Commercialization objectives in the portion of the Territory covered by such Sublicense Agreement and means by which the Sublicensee will adhere to, and promote Third Party adherence to, the Access and Stewardship Objectives. The Sublicensee shall have an obligation to devote commercially reasonable efforts to achieving the objectives and target dates of their Sublicense Access Plan.
Source: taken from a license and technology transfer agreement between Shionogi (Licensor) and GARDP (Licensee). Partner types: PDP, industry; Product type: antibiotic (cefiderocol); Development stage at signature: licensed product on WHO EML. Read in context.
Further development rights
Where a collaboration and license agreement is for early stage R&D activities, a collaboration partner may wish to secure a “first right” or “first option” to continue to further development or commercialization of a product candidate. These “option” provisions may outline parameters for the negotiation of a follow-on agreement, including the establishment of more detailed access commitments, and can provide an opportunity to ensure that continued development is conducted in a manner that will facilitate equitable access, rather than becoming focused solely on commercial objectives.
Examples from the MAPGuide
If Partner exercises the Development Option, the Parties shall negotiate a Development Agreement in good faith within a < six (6) month > period starting from the date of Partner’s notice to exercise the Development Option or such other period as the Parties may agree in writing (the “Negotiation Period”). The Development Agreement shall govern the terms under which the Development Partner:
a) contribute, along with DNDi, to financially support Phase 1, Phase 2 and Phase 3 clinical studies, and certain preclinical regulatory studies, of the Clinical Candidate;
b) be responsible for and bear all costs relating to activities concerning the clinical and industrial scale‐up of the Product and the preparation and submission of all filings and applications for regulatory approvals of the Product for the Field in the Territory;
c) conduct the manufacture of the Product in such a way as to ensure its widespread availability in the Field in the Territory;
d) distribute the Product for the Field on an Affordable Basis in the Territory; and
e) together with DNDi, monitor and manage the risk of the development of disease resistance should the same Product be used to treat humans and animals for diseases in the Field.
Source: taken from DNDi’s template Research Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from early stage discovery through to pre-clinical studies. Read in context.
Prior to offering any Third Party the opportunity to acquire a license to develop a Collaboration Compound upon which [Licensee] has decided not to enter into Phase 3 or to cease Development, [Licensee] shall provide [Licensor] with the opportunity in writing to consider whether [Licensor] wishes to acquire a license to further develop such Collaboration Compound for use in the Field of Use and to make, have made, import, sell and offer to sell products containing such Collaboration Compound for use in the Field of Use.
Source: taken from a research and product development agreement between Bayer CropScience and SentiSearch. Partner types: industry; Product type: insect vector control; Development stage at signature: discovery. Read in context.
Retained rights
Some license agreements include rights for the licensor to take actions to facilitate equitable access to a licensed product or technology if a licensee chooses not to, or is unable to, commercialize a product in certain markets or fields of use.
These provisions, which are sometimes referred to as “humanitarian purpose” rights, often take the form of rights for the licensor to grant licenses to third parties (or request that the licensee grants a sublicense); and/or a right for the licensor to remove or reduce the scope of an exclusively licensed field or territory. Where the development of the licensed IP and/or the activities carried out under the agreement are supported by a third party funder, the agreement may also include a provision establishing an access license that may be exercised directly by the funder.
Common approaches to humanitarian purpose or similar rights include some or all of the following steps:
The licensee has the first right to commercialize the licensed product in lower income markets, but may choose not to do so.
The licensor may request that the licensee grant a sublicense to a qualified third party that has expressed its willingness and ability to meet access needs in unaddressed markets. Qualified third parties, sometimes referred to as Qualified Humanitarian Organizations, are often limited to non-profit organizations.
Upon notification of a request from a qualified third party, the licensee has a first right to either: (i) negotiate an agreement directly with the third party; or (ii) develop and implement a plan for commercialization of the licensed product in the unaddressed markets.
If the licensee does not reach an agreement with the qualified third party within a certain period of time, the licensor may grant a license directly to the third party. Any such license grant is usually restricted to lower-income markets (often tied to definitions of Developing Countries, Public Markets, and/or Gavi Countries).
The licensor may only permitted to grant rights under its own intellectual property, and may not have the right to grant licenses to use the licensee’s foreground IP. In cases where the licensee has undertaken a substantial amount of additional product development work, the lack of rights to the licensee’s IP may mean that the qualified third party needs to repeat product development steps (e.g., conducting clinical trials, regulatory submissions) before it is able to commercialize a product, therefore delaying access.
Licenses to a third party will be terminated in the event of any product diversion.
Examples from the MAPGuide
For clarity, this provision does not require [Licensee] to license, or permit [Licensor] to license on its behalf, any of its information or intellectual property or products to any third party.
[…]
Should [Licensee] have no plans to commercialize Licensed Product in GAVI Countries, subject to all other terms and requirements herein, [Licensor] has the right to grant a nonexclusive license to the Licensed Patent Rights (but not jointly-owned Licensed Patent Rights) to a Qualified Humanitarian Organization solely for Humanitarian Purposes in the Public Charitable Market, but only as needed to produce products for end use in GAVI Countries. Such a license shall not be granted until (i) [Licensee] has developed a Licensed Product or Licensed Service that is proven to be capable of scalable manufacture that permits distribution (including all relevant logistical considerations) and sale of the Licensed Product or Licensed Service in GAVI Countries at locally-affordable prices (with a reasonable profit and while reasonably protecting other markets) and with consistent quality, and (b) after the [Licensee] has a bona fide offer to do so with a viable manufacturing and commercial partner proven to be capable of effectively working in the GAVI Country in compliance with all relevant laws, rules, regulations, guidelines and standards, and the [Licensee] refuses such opportunity without a reasonable explanation as to the reasons why the same would not be commercially reasonable. The third-party license shall terminate automatically if (i) any Licensed Product (whether or not in development) is made available in any Non-GAVI Country directly or indirectly by the licensee, or if any other intellectual property of [Licensee] or [Licensor] is infringed or misappropriated by the making, using, selling or importation of any relevant products, or (ii) a compulsory license is granted in such jurisdiction. Prior to entering any licenses with third parties pursuant to this provision, [Licensor] will give at least twelve (12) months’ prior written notice to [Licensee] of [Licensor]’s intent to consider or enter into such a license or manufacture and distribute in such market on its own, which notice will include all pertinent information concerning the opportunity, and [Licensee] shall have the first right to negotiate a license directly with the organization.
Related definitions:
- “GAVI Country” shall mean any country listed as eligible to receive support from the GAVI Alliance (as such list may be amended from time to time, provided it shall not include any major market countries or Brazil, Russia, India or China.)
- “Humanitarian Purpose” shall mean practice of the Licensed Patent Rights by a Qualified Humanitarian Organization to manufacture Licensed Products in GAVI Countries for which no reasonable alternatives exist in such GAVI Countries, for the sole and express purposes of distribution of such Licensed Products in one or more GAVI Countries solely in the Public Charitable Market for end use by low-income end users in such GAVI Country at actual cost (with no profit) or no cost to the end user or the end user’s governmental entities.
- “Non-GAVI Country” shall mean any country that is not a GAVI Country.
- “Qualified Humanitarian Organization” shall mean any not-for-profit organization that addresses the public health needs of underserved populations solely on a not-for-profit basis. For clarity, Qualified Humanitarian Organizations do not include governmental organizations, foundations, generic biological or pharmaceutical companies, and foundations or non-for-profit organizations that are formed or established for the benefit of, or which partner with, or support, any for-profit or governmental entity.
- “Public Charitable Market” shall mean markets that, due to economic circumstance and public health emergency cannot afford to purchase Licensed Products at the cost for which such Licensed Products are available in their country. The Public Charitable Market shall not include product tender markets (such as PAHO or UNICEF) or private markets.
Source: taken from a license agreement between Johns Hopkins University (Licensor), and Aduro Biotech (Licensee). Partner types: academic institution, industry; Product type: platform technology – cancer treatment; Development stage at signature: early stage development. Read in context.
If [Licensor] or [Licensee] or an Affiliate receives a bona fide request from a capable third party for a license under the Patent Rights to develop and commercialize a Licensed Product and/or Licensed Process at affordable prices in one or more Developing Countries that is not being sold (including without limitation sufficient supply to meet market demand at reasonable costs) or diligently developed for sale by [Licensee] or an Affiliate or Sublicensee in such Developing Country(ies), then the party receiving such inquiry shall promptly notify the other party in writing within [**] days of such inquiry (an “Inquiry Notice“), setting forth the type of Licensed Product and/or Licensed Process desired, the commercialization area desired, the name and contact information of the third party, and any other pertinent information.
Within [***] months of such Inquiry Notice, during which time [Licensee] may consult with [Licensor] regarding the request, [Licensee] shall enter into a sublicense agreement containing commercially reasonable terms and conditions with such third party for the requested Licensed Product and/or Licensed Process in the requested Developing Country(ies). If [Licensee] does not grant a sublicense under the Patent Rights to the third party within [***] months of such Inquiry Notice, and [Licensor], at its sole discretion, determines that a sublicense to the third party is reasonable under the totality of the circumstances (taking into account development efforts of [Licensee], Affiliates and Sublicensees) to make Licensed Products and/or Licensed Processes available in Developing Countries, then [Licensor] shall have the right to grant a non-exclusive license under the Patent Rights to such third party for such purposes and shall notify [Licensee] of any such license that is granted.
Source: taken from an exclusive license agreement between M.I.T. (Licensor) and Visterra (Licensee). Partner types: academic institution, industry; Product type: dengue monoclonal antibodies; Development stage at signature: pre-clinical. Read in context.
The licensed Patent Rights were developed with funding from [Funder]. Subject to the provisions of Subsection [x] below, and in conjunction with the rights granted in that subsection, Licensee shall grant to [Funder] a nonexclusive, irrevocable, perpetual, transferable, royalty free license with the right to sublicense, to use, manufacture, make, have made, produce, reproduce, distribute, copy, offer to sell, and sell solely for the benefit of the developing world, inventions of any Secondary Patents, to be exercised by [Funder] at its sole discretion which [Funder] has agreed [Funder] will not undertake unless [Funder], after consultation with the Licensee, determines that the Licensee has not, within a reasonable time, made the [Funder] supported invention and the subject of the Secondary Patents, available to the developing world in a manner consistent with the global access plan and the charitable objective of the [Funder] funding.
Source: taken from a license agreement between Elkurt, Inc (Licensor) and Ocean Biomedical, Inc. (Licensee). Funding for the development of the licensed rights was provided by the Foundation for the National Institutes of Health (FNIH). Partner types: academic institution, industry; Product type: malaria vaccine; Development stage at signature: unknown. Read in context.
When the public health and safety so require, and after written notice to Licensee providing Licensee a ninety (90) day opportunity to respond, [Licensor] shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in the Licensed Field of Use under the Licensed Patent Rights, unless Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. [Licensor] will not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee. If Licensee is required to grant sublicense(s) under this Paragraph [x], Licensee agrees to provide [Licensor] and said sublicensee(s) with all data, documents and materials generated or produced by or on behalf of Licensee that would be or could be used in regulatory filings with the Food and Drug Administration (or foreign equivalent regulatory agency). Licensee agrees that such data, documents and/or materials can be used by [Licensor] or said sublicensee(s) to prepare regulatory filings with the Food and Drug Administration (or equivalent foreign regulatory agencies). Licensee may charge a fee to said sublicensee(s) that is equal to its direct costs only (i.e., no overhead shall be compensated) for producing said data, documents and materials that said sublicensee(s) actually use in their regulatory filings.
Source: taken from a license agreement between the U.S. NIH (Licensor) and Biosyn (Licensee). Partner types: Government, Industry; Product type: HIV prophylactic; Development stage at signature: unknown. Read in context.
License terms will include mandatory sublicensing or surrender of rights in countries where diligence is not pursued consistent with the Development Plan. Exclusive licenses will include “pull back” terms for new or unmet needs that the licensee elects not to pursue or cannot commit to pursue. An exclusive licensee may be required to sublicense, reduce the license to non-exclusivity, or to relinquish rights to sell or distribute product in a particular territory or for a particular indication when the Development Plan milestones are not met, and the Licensee does not provide an adequate plan to remedy the lack of diligence. Alternatively, [Licensor] may terminate the license in its entirety as necessary to ensure successful development and commercialization in the Field.
Source: taken from the US NIH’s model license agreement terms for non-profit institutions. Partner types: government, non-profit research institutions and PDPs; Product type: products in the field of NTDs, malaria, TB and HIV; Development stage at signature: multiple. Read in context.
Termination rights
It is important for license and collaboration 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 provide a pathway for continued development and/or commercialization of a licensed product or technology to support the achievement of equitable access objectives.
Grounds for termination
Grounds for termination that are common across a broad range of agreements material breach, bankruptcy or insolvency proceedings, force majeure, fraud, and changes in ownership or control. Agreements can also include termination rights related to non-compliance with or non-fulfilment of access commitments, for example if a licensee or collaboration partner:
- Fails to make progress towards equitable access objectives. Termination on these grounds may be subject to a “cure period” for the licensee or collaboration partner to develop and implement a plan to make reasonable progress;
- Makes sales of a licensed product without meeting quality assurance requirements, such as obtaining approval from a stringent regulatory authority or WHO PQ; or
- Makes sales of a licensed product outside of the access territory.
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 including access-related obligations.
In addition to these general requirements, effects of termination provisions can include rights for a licensor or collaboration partner to use the other party’s IP, data and materials for further product development and commercialization, therefore providing a mechanism for continued progress towards equitable access objectives.
Examples from the MAPGuide
Grounds for termination
[Licensor] will have the right to terminate this Sublicense Agreement upon delivery of written notice to the Sublicensee upon the occurrence of any of the following:
- the failure of the Sublicensee to use its reasonable best efforts to diligently implement the Manufacturing of, and to obtain and maintain all required Manufacturing Approvals for, the Manufacture of quality Licensed Compound and Licensed Product at the Facility(ies) and to Manufacture sufficient and affordable quantities of quality Licensed Compound and of Licensed Product to supply in a timely manner the requirements of Commercial Sublicensees and of [Licensor] for patients in need in the Territory. […]
- the occurrence of any material safety issue that Shionogi or [Licensor] reasonably believes makes it inadvisable to proceed or continue with the Commercialization of the Licensed Product in the Territory;
- […] a cross border diversion of the Licensed Product whereby the Sublicensee uses, offers for sale, sells, or has sold Licensed Products for use in any country outside of the Territory, whether directly or indirectly or through a Third Party, located in or out of the Territory, except in cases where such diversion outside of the Territory results from the action of a Commercial Sublicensee without knowledge of the Sublicensee, and where the Sublicensee, upon becoming aware of such diversion, takes all appropriate action and uses diligent efforts to cause such diversion to cease;
- any failure by the Sublicensee to comply with the quality requirements under Section [x] of this Sublicense Agreement for any Licensed Product Manufactured by Sublicensee;
- the failure of the Sublicensee to diligently implement an Access Action Plan agreed in accordance with Section [x];
Source: taken from a sublicense agreement between GARDP (Sublicensor) and Orchid Pharma (Sublicensee) related to a head license between GARDP and Shionogi. Partner types: PDP, industry; Product type: antibiotic (cefiderocol); Development stage at signature: licensed product on WHO EML. Read in context.
If, in the reasonable opinion of the [Licensor], the Licensee fails to promote access or appears in [Licensor]’s reasonable opinion, will fail to promote access to the Products in the Territory in accordance with this Agreement, the [Licensor] shall give notice to the Licensee requiring it to cure such failure. If, in the reasonable opinion of the [Licensor], the Licensee fails to present an acceptable plan within 60 days and report reasonable progress within 180 days after receiving written notice with respect to the default, the [Licensor] shall have the right to terminate this Agreement with immediate effect by giving written notice to the Licensee. In making such determination of reasonable progress, the [Licensor] shall take into account the period within which the relevant authorities provide the necessary approvals and normal development lead time for the Products, and progress reported by Licensee in its quarterly reports and meetings provided under Section [x] of this Agreement.
Source: taken from a form of sublicense agreement attached to a head license agreement between Merck (Head Licensor) and MPP (Licensor). Partner types: multilateral, industry; Product type: COVID-19 therapeutic (molnupiravir); Development stage at signature: late clinical/pending EUA. Read in context.
If in the reasonable opinion of [PDP], Partner fails to use Reasonable Efforts to promote access to the Product in the Territory in accordance with the timelines and milestones agreed by the Parties under the Access and Implementation Plan(s), [PDP] shall give notice to Partner requiring curing such failure. If, in the reasonable opinion of [PDP], Partner fails to present an acceptable plan within sixty (60) days and report reasonable progress within one hundred and eighty (180) days after receiving written notice with respect to the default, [PDP] shall have the right to terminate this Agreement in respect to such Product with immediate effect by giving written notice to Partner.
Source: taken from DNDi’s template Development Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from Phase 1 clinical trials through to proof of concept in humans. Read in context.
Effects of termination
Upon termination by Partner pursuant to Section [termination for convenience] or termination by [PDP] pursuant to Section [termination for breach, insolvency or force majeure] – or Section [failure to promote access]:
- […]
- Partner shall grant to [PDP] a non–exclusive, perpetual, irrevocable, fully paid, royalty–free license, with the right to sublicense, under Partner’s rights to and interests in Partner Background Technology and Partner Collaboration Technology, to sell, offer to sell, import and distribute the Product within the Field outside of the Territory; […]
- Partner shall make available to and/or transfer to [PDP], copies of such information, documentation and materials in its possession relating to the Development and Distribution Program so that [PDP] may proceed with further research and development, manufacture, registration and/or commercialisation of the Product. In particular, Partner shall transfer, to the extent owned, licensed or controlled by Partner, copies of the Partner Collaboration Technology, and provide the necessary training (including onsite), free of charge, to any Third Party appointed by [PDP] on Product manufacture. To ensure continuity in the supplies of the Product, Partner shall continue to manufacture and supply the Product in accordance with the terms of this Agreement until such time as the technology transfer to the Third Party appointed by [PDP] is complete and such Third Party is manufacturing and supplying the Product. Partner shall transfer all existing stocks of the Product to the Third Party following the completion of such technology transfer and launch of manufacture and supply by such Third Party as described in the preceding sentence;
- Partner shall transfer to [PDP] the Regulatory Dossier and any supporting documentation, including the Marketing Authorization(s) and Regulatory Approvals in its possession; […]
Source: taken from DNDi’s template Development Collaboration and License Agreement. Partner types: PDP, industry/academic institutions; Product type: treatments for neglected diseases; Development stage at signature: template intended for use from Phase 1 clinical trials through to proof of concept in humans. Read in context.
Upon termination of this Agreement by either of the parties, Licensee will grant [Licensor] a non-exclusive, irrevocable, perpetual, fully paid-up, sublicensable, worldwide license to all inventions, products, materials, methods, processes, techniques, know-how, data and information discovered or developed in the course of or arising from Licensee’s development and commercialization of the Patent Rights (“Developments”) under this Agreement to the extent such a license may lawfully be granted.
Source: taken from a license agreement between UCLA (Licensor) and Radiopharm Theranostics (Licensee). Partner types: academic institution, industry; Product type: cancer treatment (“DUNP19” antibody); Development stage at signature: pre-clinical. Read in context.
Upon termination of this Agreement, if Licensee has filed patent applications or obtained patents to any modification or improvement to Licensed Products within the scope of the Patent Rights, Licensee agrees upon request to enter into good faith negotiations with [Licensor] or [Licensor]’s future licensee(s) for the purpose of granting licensing rights to said modifications or improvements in a timely fashion and under commercially reasonable terms.
Source: taken from the University of Michigan’s template exclusive license agreement. Partner types: industry; Product type: therapeutics; Development stage at signature: multiple. Read in context.
Regulatory Filings; Data. To the extent permitted by applicable Laws, [Licensee] shall transfer and assign to [Licensor] all Regulatory Filings, Regulatory Approvals, and related preclinical, analytical, and clinical data for the Product throughout the Licensed Territory. If the transfer of any such Regulatory Filings, Regulatory Approvals, and related preclinical, analytical, and clinical data is prohibited by applicable Laws, [Licensee] shall grant [Licensor] an exclusive, perpetual, royalty-free, license and a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, to such Regulatory Filings, Regulatory Approvals, and related preclinical, analytical, and clinical data to Develop, Manufacture or Commercialize the Licensed Antibody or Product and shall cooperate in good faith with [Licensor] to allow [Licensor] to make full use thereof, including by executing documents and making filings with Regulatory Authorities upon [Licensor]’s reasonable request.
[Licensee] License. Within sixty (60) days following the effective date of termination, [Licensor] may elect upon written notice to [Licensee] to receive the license provided for in this Section [x]. Effective upon [Licensee]’s receipt of [Licensor]’s election to receive such license, [Licensee] hereby grants to [Licensor], a non-exclusive, royalty-bearing license under [Licensee] Technology to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize Products in the Licensed Territory, which license shall be effective as of the date of such termination. In consideration for such license, the Parties shall agree to, and [Licensor] shall pay [Licensee], a commercially reasonable royalty on Net Sales of Products in the Licensed Territory which royalty shall be determined by the Parties taking into account the commercial value of such [Licensee] Technology and the value of any Product Marks assigned to [Licensor] pursuant to Section [x]; provided, that in no event shall the royalty payable by [Licensor] to [Licensee] under this Section [x] exceed the royalty rate payable by [Licensee] under Section [x].
Transition Assistance. [Licensee] shall provide such reasonable assistance, at no cost to [Licensor] (except as set forth in Section [x]), as may be reasonably necessary or useful for [Licensor] to commence or continue, at [Licensor]’s cost, Developing or Commercializing Products in the Licensed Territory, to the extent [Licensee] is then performing or having performed such activities, including without limitation transferring or amending as appropriate, upon request of [Licensor], any agreements or arrangements with Third Party vendors to sell Products in the Licensed Territory. To the extent that any such contract between [Licensee] and a Third Party is not assignable to [Licensor], then [Licensee] shall reasonably cooperate with [Licensor] to arrange to continue to provide and provide such services from such entity.
Source: Taken from a license and collaboration agreement between Visterra (Licensor) and Serum Institute of India (Licensee). Partner types: industry; Product type: dengue monoclonal antibodies; Development stage at signature: pre-clinical. Read in context.
What is the scope of any exclusive rights granted under the agreement, and how does that impact retained rights required as a safeguard for equitable access objectives?
What are the mechanisms for resolving disagreements regarding the licensee/collaboration partner’s fulfilment of its access obligations and/or exercise of an access license?
Will the reporting requirements under the agreement provide the licensor with sufficient information to monitor the licensee/collaboration partner’s compliance with access obligations?
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.