MAPGuideⓇ
Equitable Access Toolkit
How Can the Scope of a License Agreement Impact Access to the End Product?
The extent to which a license agreement can facilitate equitable access to an end product may depend on the scope of the licensed rights. Some of the key questions to address in defining the scope of a license agreement are:
Is the license exclusive or non-exclusive? Is exclusivity limited to a specific field or market (or both)?
In which countries and for which markets is the licensee allowed to develop, manufacture and commercialize licensed products?
For what diseases or indications is the licensee permitted to develop or commercialize licensed products?
Does the license relate to patents only or does it also include other intellectual property (IP) such as know-how? Will the licensor make a technology transfer package available and provide technology transfer support?
Are there any restrictions on the licensee’s use of the licensed IP?
Exclusivity
In general terms, a non-exclusive license means that the licensor can license the same rights to other parties and practice the licensed rights itself, whereas an exclusive license means that the licensor cannot grant licenses to third parties other than the exclusive licensee. Exclusive licenses can be exclusive “even as to the licensor”, meaning that the licensee is the only party that is allowed to practice the licensed rights, or they may include “retained rights” for the licensor. Retained rights, also referred to as “reserved rights”, allow the licensor to practice the licensed rights in certain circumstances, for example, universities often retain rights for research, educational and non-commercial purposes.
Exclusive licenses are often seen as a potential barrier to equitable access as they may limit opportunities for price competition and sufficient global supply and/or limit the ability of other innovators to develop and commercialize other products based on the licensed technology.
However, in some circumstances, such as for early-stage technologies which still carry a high risk of failure, innovators may view exclusivity as a necessary condition to generate interest in the technology and incentivize potential licensees or collaboration partners. Options for managed exclusivity that may better facilitate equitable access while still providing sufficient incentive for licensees include:
Restricting exclusivity to a certain territory so that the licensor can select different licensees based on their ability to meet the needs of different markets (see below for discussion of territory definitions);
Limiting exclusivity to a certain period of time;
Restricting exclusivity to a certain field so that an exclusive license does not prevent development and commercialization of different products or product types based on the same licensed technology (see below for discussion of field definitions);
Reserved rights for the licensor to grant additional licenses or remove license exclusivity if required for equitable access purposes. These provisions are discussed further under Enforcement & Continuity.
Examples from the MAPGuide
The [Licensor] reserves on behalf of itself and any other educational or nonprofit institutions the right to make, use, and practice the Invention, the [Licensor]’s Patent Rights, and any technology created by the [Licensor] relating to any of the foregoing for educational and research purposes, including publication and other communication of any research results.
Source: taken from UC Berkeley’s exclusive license agreement template. Partner types: academic institution, industry; Product type: therapeutics & diagnostics; Development stage at signature: dependent on licensed product/technology. Read in context.
Notwithstanding the non-exclusive nature of the license granted by [Licensor] to the Sublicensee, [Licensor] undertakes, so long as [Sublicensee] is complying with its diligence obligations in accordance with the Sublicense Access Plan and is otherwise in compliance with this Agreement, not to grant any other sublicense under the Sublicensed Rights and the Sublicensed Manufacturing Know-How to Manufacture the Licensed Compound and Licensed Product during a period of 5 years following the Effective Date. Further, [Licensor] undertakes that it will not grant any such other manufacturing sublicense for an additional 2 years (i.e. until the 7 year anniversary of the Effective Date) so long as the demand for [product] in the Territory is at most 1.5 million doses per year, [Sublicensee] is complying with its diligence obligations in accordance with the Sublicense Access Plan and is otherwise in compliance with this Agreement and [Sublicensee] is able to supply that demand during such 2-year period.
Source: taken from a sublicense agreement between GARDP (Licensor) 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.
Licensed Territory
Definition of a licensed territory can be approached in a number of ways ranging from a “worldwide” license to specific countries depending on a licensor’s commercialization strategy. As explained above, the grant of exclusive, worldwide licenses may act as a barrier to access unless there are reserved rights or other exclusivity limitations intended to address such situations.
For products for which there are potential high- and low- income markets (also referred to as “dual market”), access-oriented licensing approaches can involve making distinctions between high income (or “major market”) countries and lower-income markets. A licensor may retain the right to exploit high income markets itself -or grant a license for major markets to a commercial partner- while also granting access-oriented licenses to licensees that are willing and able to meet the affordability and availability needs of lower-income markets. Such approaches can facilitate equitable access as well as generating benefits for licensors by unlocking new revenue streams and expanding patient reach.
Criticisms have been leveled at some license agreements that are granted for the purpose of facilitating equitable access but exclude countries with a high burden of disease and/or substantial underserved populations from the licensed territory. While a preferred approach may be for such licenses to include all low- and middle-income countries, in cases where the licensor wishes to retain some territories for itself, mechanisms to achieve the broadest possible territory could include:
Dividing rights between public and private markets in countries for which the licensor wishes to retain any potential commercial market for itself;
Rights for development and manufacturing in certain countries (the “licensed territory”), with sales permitted into additional countries where there is no patent in force;
Permitting sales outside of the licensed territory provided that there is no use of a technology transfer package;
Permitting sales to procurement entities based outside of the territory provided that the product purchased is for ultimate use within the territory;
Agreement to extend the licensed territory if the licensee can demonstrate that demand is not met by existing supply;
Including provisions expressly acknowledging that the licensee is not prohibited from supplying to any country where a compulsory license is in force, nor from conducting activities that would not infringe on a licensed patent that is granted and in force; and/or
Negotiating a tiered royalty structure as an incentive for the licensor to allow the licensed territory to include countries in which it already has some sales operations.
Examples from the MAPGuide
WHEREAS, subject to the terms of this Agreement, [Licensor] agrees to (a) continuously supply to [Licensee] Vaccine Components as per the Forecast requirement of [Licensee] in the [Licensee] Territory, (b) grant to [Licensee] an exclusive license in the [Licensee] Exclusive Territory (defined hereunder) to use the Vaccine Components to enable [Licensee] to Manufacture, and Commercialize the Product, (c) grant to [Licensee] a nonexclusive license in the [Licensee] Non- Exclusive Territory (defined hereunder) to use the Vaccine Components to enable [Licensee] to Manufacture, and Commercialize the Product, and (d) provide to [Licensee] that Licensed Know- How Controlled by [Licensor] or its Affiliates (including the improvements if any), in accordance with the terms and conditions of this Agreement.
Related definitions:
- “[Licensor] Exclusive Territory” shall mean a) during the Pandemic Period (as determined by the WHO) the countries of [***] and b) immediately following the Pandemic Period, any other country designated as a high income country (including sub-designations of high income countries (e.g., a “low high income country”) according to the then most recent published Word Bank classification of world countries as of the first day of the end of the Pandemic Period or included within the [Licensor] Territory in accordance with Section [x] (Non-Exclusive License).
- “[Licensee] Exclusive Territory” shall mean India.
- “[Licensee] Non-Exclusive Territory” shall mean a) during the Pandemic Period all the other countries EXCEPT [Licensee] Exclusive Territory and [Licensor] Exclusive Territory and b) immediately following the Pandemic Period only those countries designated as low or middle income countries (including any sub-designations of low or middle income countries (e.g., a “high middle income country”) according to the then most recent published Word Bank classification of countries as of the first day of the end of the Pandemic Period (“LMIC”), subject to and may be modified in accordance with Section [x]. (Non-Exclusive License).
Source: taken from a license and supply agreement between Novavax (Licensor) and Serum Institute of India (Licensee). Partner types: industry; Product type: COVID-19 vaccine; Development stage at signature: clinical trials. Read in context.
[Licensor] hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, an exclusive license under the Licensed Patent Rights and the exclusive rights to use the Biological Materials in the Exclusive Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import or to export any Licensed Product in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.
During the term of this Agreement, Biological Materials shall not be provided by [Licensor] to any third party except under written agreement prohibiting the practice of the rights granted hereunder in the Exclusive Licensed Territory for commercial purposes. For clarification, Biological Materials may be provided under Research Licenses as described in Paragraph [x].
[Licensor] hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, a non-exclusive license under the Licensed Patent Rights and non-exclusive right to use the Biological Materials in the Non-Exclusive Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import or to export any Licensed Product(s) in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.
Related definitions:
- Exclusive Licensed Territory: Europe, Canada and United States of America
- Non-Exclusive Licensed Territory: Worldwide excluding Europe, Canada, United States of America, India, Brazil, and China For the sake of clarification, the Non-Exclusive Licensed Territory includes (without limitation) Australia, Japan, and South Korea, where patents and patent applications under Licensed Patent Rights have been filed or issued.
Source: taken from a license agreement between the U.S. NIH (Licensor) and Aridis (Licensee). Partner types: public research institute, industry; Product type: rotavirus vaccine; Development stage at signature: early stage development. Read in context.
During the Term and subject to the other terms and conditions of this Agreement, [Licensor] hereby grants [Licensee] an exclusive option during the Option Period, exercisable in accordance with Section [x], for [Licensee] to obtain a non-exclusive, royalty-bearing license, under the [Licensor] Technology, to research, Develop, make, have made, use, sell, offer for sale, have sold, import, export and otherwise Commercialize and exploit the Product in the Field in the Option Territory (the “Option”).
Related definitions:
- “Licensed Territory” means India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives and Sri Lanka.
- “Option Territory” means all countries and territories in the world excluding the Licensed Territory and the Retained Territory.
- “Retained Territory” means all countries and territories in North America, Central America, the Caribbean, South America and the EU and Australia, Japan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
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.
In the event that the [Licensee] can demonstrate that within twelve months of the first Approval Date relevant to a particular Royalty Country, demand for Product in such Royalty Country in the Private Market is not met by supply (other than due to temporary supply interruptions), then the Parties shall enter into good faith discussions with the intention of amending one or more Sub-Licences as they apply to that jurisdiction to include such Private Market within the scope of its licence to address such a shortfall.
Source: Taken from a license agreement between ViiV Healthcare (Licensor) and MPP (Licensee). Partner types: industry, multilateral; Product type: antiretroviral (dolutegravir); Development stage at signature: US FDA & EMA approval. Read in context.
[Licensor] hereby grants, on its own behalf and on behalf of its Affiliates, to the [Licensee] a limited, non-exclusive, perpetual and irrevocable […], sublicensable […], royalty-free, fully paid-up license under and with respect to the Licensed Patents and the Licensed Know-How to (a) Develop, anywhere in the world, Licensed Products for use in the Licensed Field, (b) Manufacture and have Manufactured Licensed Products (and any ingredients thereof, including the [Licensor] Antibodies) anywhere in the world for use in the Licensed Field, and (c) Commercialize Licensed Products in the Licensed Field in the Territory.
Related definitions: “Territory” means the countries set forth on Schedule [x]. The Parties may amend the Territory to include other countries that, as of the date on which the Licensed Product obtains WHO prequalification, are eligible for support by Gavi, the Vaccine Alliance (formerly known as Global Alliance for Vaccines and Immunizations), or are identified by the Malaria Vaccine Advisory Committee (MALVAC) of the WHO as Malaria-endemic countries. Any such amendment will be subject to the Parties’ mutual written agreement.
Source: taken from a license agreement between Atreca (Licensor) and the Gates Medical Research Institute (Licensee). Partner types: non-profit research institution, industry; Product type: prophylactic malaria mAb; Development stage at signature: pre-clinical. Read in context.
Upon the terms and subject to the conditions set out in this Sublicense Agreement, [Sub-Licensor] hereby grants to the Sublicensee, and the Sublicensee hereby accepts, a non–exclusive, non–sublicensable, royalty–bearing, non–transferable license under the Licensed Patent Rights and the Licensed Manufacturing Know-How to make, or have made, use, offer for sale, sell, have sold, export or import the Licensed Compound and Licensed Products anywhere in the world exclusively for ultimate use in the Field in the Territory.
Source: Taken from a form of sublicense agreement annexed to a head license agreement between Bristol-Myers Squibb (Licensor) and MPP (Licensee). Partner types: industry, multilateral; Product type: antiretroviral (atazanavir); Development stage at signature: WHO recommended licensed product. Read in context.
Subject to the terms of this Agreement and with effect from the Effective Date, the [Licensor] grants to [Licensee]:
A non-exclusive, non-transferable worldwide licence under the Licensed Technology to grant sub-licences, in accordance with the terms set forth in Schedule [x], to Development Partner(s) to develop, or have developed, ARV-SDNs into Licensed Products in the Field; and
A non-exclusive, non-transferable, royalty-bearing worldwide licence under the Licensed Technology to grant sub-licences, in accordance with the terms set forth in Schedule [x], to Commercialisation Partner(s) to make, have made, use, offer for sale, sell, have sold, export or import the Licensed Products in the Field exclusively for administration to patients in the Territory.
Source: taken from a license agreement between the University of Liverpool (Licensor) and MPP (Licensee). Partner types: multilateral, academic institution; Product type: HIV therapeutic (nanomedicine); Development stage at signature: early clinical. Read in context.
[…] Licensor hereby grants to Licensee:
(a) a non-exclusive, non-transferable license to grant sublicenses in accordance with Section [x] under the Territory Patents to Exploit the Licensed Products in the Field and in the Territory;
(b) a non-exclusive, non-transferable license to grant sublicenses in accordance with Section [x] under the [Licensor] Patents to Manufacture and Develop the Licensed Compounds and Licensed Products solely for the purpose of Commercialization of Licensed Products in the Field and in the Territory;
(c) a non-exclusive, non-transferable license to grant sublicenses in accordance with Section [x] under the [Licensor] Patents to sell, offer to sell, or otherwise distribute Licensed Products to Non-Territory Eligible Purchasers solely for the purpose of Commercialization of Licensed Products in the Field and in the Territory;
(d) and a non-exclusive, non-transferable license to grant sublicenses in accordance with Section [x] under the [Licensor] Patents to sell, offer to sell, or otherwise distribute Licensed Compounds solely for the purpose of Commercialization of Licensed Products in the Field and in the Territory.
[…]
Nothing in this Agreement shall be construed to prevent Sublicensees from engaging in any activities where such activities would not infringe [Licensor] Patents granted and in force, including, without limitation, where a country has issued a compulsory license on [Licensor] Patent(s).
Source: taken from a license agreement between AbbVie (Licensor), and MPP (Licensee). Partner types: industry, multilateral; Product type: antiretroviral HIV medicines (lopinavir and ritonavir) for pediatric use; Development stage at signature: WHO-recommended licensed product. Read in context.
Below is the initial list of Target Countries. The Parties shall consult at least every three years [(starting in INSERT CALENDAR YEAR)] in order to update and include in or delete from the then-current version of Schedule [x] any country, territory or area that, as relevant: (1) has been or ceases to be classified as low income or lower-middle income by the World Bank, or (2) has been or ceases to be classified as upper middle income by the World Bank and meets or ceases to meet the criteria set out in Section [x] of this Agreement. As part of the aforementioned consultation between the Parties, to the extent that a country, territory or area is to be deleted from the then-current version of Schedule [x], and Sublicensee has sold the Licensed Product in such country, territory or area in compliance with the terms and conditions of the Sublicence, the Parties shall consider and agree on a case-by-case basis, in good faith, on a transition plan for the continued sale of the Licensed Product and any limitations thereto, in such country, territory or area, as appropriate.
Related definitions: “Target Country(ies)” is/are defined as: (a) low-income and lower middle-income countries; and (b) upper middle-income countries, if and to the extent such upper middle-income countries have an elevated incidence of maternal mortality, defined as being greater than 140 per 100,000 live births, and such countries fulfil one of the following additional criteria: (i) capability to maintain cold chain is an issue; or (ii) the normal commercial price for [product] would constitute an impediment to access in the Public Sector (it being understood that low income, lower-middle income and upper-middle income countries will be determined based on then-current World Bank classifications).
Source: taken from a memorandum of understanding between Ferring (Licensor) and MPP (Licensee). The MOU includes a form of license agreement and sublicense agreement. Partner types: industry, multilateral; Product type: prevention and treatment of post-partum hemorrhage (heat-stable carbetocin); Development stage at signature: WHO PQ for prevention; clinical trials for treatment. Read in context.
Licensed Field
A licensed field of use under a license agreement may be broad – for example allowing the development and commercialization of licensed products for the treatment, prevention or diagnosis of any disease – or it may be restricted to certain indications. Definitions of licensed field may specify certain diseases, formulations (including whether combination products are permitted), patient groups (e.g., pediatric use only). As noted above, exclusive license agreements with broad licensed fields may act as a barrier to access absent reserved rights or other provisions that could be triggered to narrow the scope of exclusivity in certain circumstances.
Examples from the MAPGuide
“Field” shall mean with respect to a particular Product any use that is consistent with the label approved by Relevant Regulatory Authority in the country of sale for the use of such Product.
Source: taken from a license agreement between Novartis (Licensor) and MPP (Licensee). Partner types: industry, multilateral; Product type: cancer therapeutic (nilotinib); Development stage at signature: licensed product on WHO EML. Read in context.
“Field” shall mean the use of Licensed Products containing a polymer and a therapeutic agent for the treatment of cancer. Notwithstanding the foregoing, the Field shall specifically exclude the use of Licensed Products: (i) for the treatment of brain cancer; (ii) for therapeutic or prophylactic cancer vaccines, including where such vaccines incorporate an adjuvant but not an antigen; and (iii) for therapeutic or prophylactic vaccines for infectious diseases or allergies.
Source: taken from a license agreement between Yale University (Licensor) and BIND Biosciences (Licensee) for the development and commercialization of licensed products and methods for the treatment of cancer. Partner types: academic institution, industry; Product type: cancer treatment; Development stage at signature: unknown. Read in context.
“Field” shall mean the pediatric treatment or prevention of HIV
Source: taken from a license agreement between AbbVie (Licensor), and MPP (Licensee). Partner types: industry, multilateral; Product type: antiretroviral HIV medicines (lopinavir and ritonavir) for pediatric use; Development stage at signature: WHO-recommended licensed product. Read in context.
“Field” means human prophylactic uses of a vaccine for SARS-CoV-2 disease.
Source: taken from a license and supply agreement between Novavax (Licensor) and Serum Institute of India (Licensee). Partner types: industry; Product type: COVID-19 vaccine; Development stage at signature: clinical trials. Read in context.
“Field” means Malaria, insect-borne, and other parasitic diseases.
Source: taken from a license agreement between Elkurt, Inc (Licensor) and Ocean Biomedical, Inc. (Licensee). Partner types: academic institution, industry; Product type: malaria vaccine; Development stage at signature: unknown. Read in context.
“Exclusive Licensed Field of Use“: (i) Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to be delivered to the brain or liver for treatment of human diseases originating in the brain or liver; (ii) Note that arthritis related diseases are expressly excluded.
“Non-Exclusive Licensed Field of Use“: Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to treat any human disease in any manner, where the treatment of such disease in such manner is not included in the Exclusive Licensed Field of Use.
Source: taken from a license agreement between the US NIH (Licensor) and uniQure (Licensee). Partner types: Government, Industry; Product type: treatments for multiple diseases; Development stage at signature: early stage development. Read in context.
During the Term, [Licensee] may request that the definition of the LMIC Field be amended to include additional Indications and [Licensor] shall consider such request(s) in good faith; provided that, [Licensor] shall have no obligation to amend the LMIC Field to include such additional Indications.
Source: taken from an LMIC license agreement between Finch Therapeutics (Licensor) and the Microbiome Health Research Institute (Licensee). Partner types: industry, non-profit research institution; Product type: therapeutics for malnutrition and NTDs; Development stage at signature: unknown.
Licensed Intellectual Property
From a licensee’s perspective, it is important to have rights to use all third party intellectual property (IP) rights required for the intended product development, manufacturing and/or commercialization activities. This requires consideration of:
A
The full scope of third party proprietary technologies or other inputs that the licensee might infringe absent the required license(s) (sometimes referred to as “freedom to operate” analysis); and
B
The scope of licensed IP as defined under a specific license agreement.
Defining Licensed IP
Licensed IP under a specific agreement generally includes patent rights, but in some cases, “licensed technology” may be more broadly defined to include other proprietary information such as materials and know-how in addition to patent rights. Definitions of licensed IP should be carefully reviewed to ensure that they are sufficient for the purposes of an agreement. Considerations may include:
- Whether the licensed patents include all potentially relevant patent rights held by the licensor;
- Whether the licensed patents include patent applications, extensions, and other future patent rights, or only patents granted and in force as at the agreement effective date.
- Whether licensed know-how and/or materials will be restricted to information listed on an agreement schedule or may more broadly encompass any “reasonably necessary” information;
- Whether identification of relevant know-how and/or materials will be solely at the licensor’s discretion.
- Whether licensed know-how and/or materials will include relevant information generated after the agreement effective date.
Technology Transfer
An additional consideration for licensed technology is the potential requirement for technology transfer activities to support the transfer of the know-how and materials to the licensee. Technology transfer provisions can place different levels of obligations on both a licensor/transferor and a licensee/transferee. Some of the key considerations include:
- The extent to which the licensor commits to supporting successful technology transfer – for example, some agreements include a “one-time” transfer package without assistance from the licensor’s personnel, whereas others include detailed shared commitments to achieving successful transfer;
- The licensee’s obligations to prepare for technology transfer, for example by ensuring that it has sufficiently qualified personnel;
- How the costs of technology transfer will be managed, for example some agreements include technology transfer fees as part of total consideration paid by the licensee/transferee; and
- If the use of a technology transfer package or licensed know-how impacts the licensee/transferee’s other rights and obligations under the agreement. For example, some agreements include additional royalty obligations or allow sales in additional countries if there is no use of a licensor’s know-how.
Technology transfer provisions are discussed in further detail here.
Examples from the MAPGuide
Licensed Patents means all Patents that are Controlled by [Licensor] or its Affiliates as of the Effective Date or during the term of this Agreement that are reasonably necessary or useful for (including any Patents that would be infringed, absent a license, by) the Development, Manufacture, or Commercialization of Licensed Products in the Licensed Field, including the Patents listed on Schedule 1 attached hereto.
Licensed Know-How means all Information and all Intellectual Property Rights (other than Patents) that are Controlled by [Licensor] or its Affiliates as of the Effective Date or during the term of this Agreement that are reasonably necessary or useful for the Development, Manufacture, or Commercialization of Licensed Products in the Licensed Field, and [Licensor] Biological Materials provided to [Licensee] under Section [x].
Source: taken from a license agreement between Atreca, Inc (Licensor) and Gates Medical Research Institute (Licensee). Partner types: non-profit research institute, industry; Product type: prophylactic malaria mAb; Development stage at signature: pre-clinical. Read in context.
Licensed Patents shall mean the United States or foreign patent application(s) and patents(s) listed in Appendix A and owned or co–owned by [Licensor] during the term of this Agreement, together with any continuations, divisionals, and continuations–in–part, to the extent the claims of any such patent or patent application are directed to subject matter specifically described in the patent applications listed on Appendix A; any reissues, re–examinations, or extensions thereof, or substitutes therefor; and the relevant international equivalents of any of the foregoing. Appendix A is incorporated into this Agreement.
Source: taken from a license agreement between Yale University (Licensor) and BIND Biosciences (Licensee) for the development and commercialization of licensed products and methods for the treatment of cancer. Partner types: academic institution, industry; Product type: cancer treatment; Development stage at signature: unknown. Read in context.
Licensed Know-How means all Know-How that is Controlled by [Licensor] or its Affiliates as of the Effective Date in relation to the Vaccine Components and which is necessary for the Development, Manufacture or Commercialization of Product.
Source: taken from a license and supply agreement between Novavax (Licensor) and Serum Institute of India (Licensee). Partner types: industry; Product type: COVID-19 vaccine; Development stage at signature: clinical trials. Read in context.
Licensed Manufacturing Know-How means all technical information and know–how owned and/or Controlled by [Licensor] or its Affiliates as of the Effective Date (including all manufacturing data, the percentages and specifications of ingredients, the manufacturing process, specifications, assays, quality control, and testing procedures) that is identified by [Licensor], in its good faith judgment, as reasonably necessary for the Manufacture of the Licensed Compound and/or Licensed Product in substantially the same manner that such Licensed Compound and/or Licensed Product have been Manufactured by or for [Licensor] as of the Effective Date.
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.
Licensed Technology means the Patent Rights, Material, and Licensed Know-How
Related definitions:
- “Material” means:
- Expression vectors for mammalian cells that contain recombinant DNAs that encode proteins derived from the protein S (“spike”) of SARS-CoV-2, mainly: complete protein S, region S1 and a domain (“receptor binding domain “, RBD) involved in binding to the viral receptor ACE2. Likewise, variants of protein S produced in CNB-CSIC.
- Expression vectors for E. Coli cells containing recombinant DNAs encoding proteins derived from the nucleocapsid protein (protein N) of SARS-CoV-2. Likewise, variants of the nucleocapsid protein (protein N) produced in the CNB-CSIC.
- Expression vectors for E. Coli cells containing recombinant DNAs encoding proteins derived from the SARS-CoV-2 “cysteine-like” protease (MPro) protein. Likewise, variants of the protease protein (MPro) produced in the CNB-CSIC.
- “Licensed Know-how” means all proprietary know-how and other technical knowledge relating to the Patent Rights and which may be necessary for Sublicensees to exploit the Patent Rights and Material.
- “Patent Rights” means any right recognised by the applicable patent legislation or regulation and generated by claiming the priority of the Patent Application, including the patents and patent applications set out in Schedule 1 as may be amended from time to time, such as the rights generated by: (a) any patent application, any continuation-in-part, division, extension for any such application, and any patent issuing on such application; (b) inventor certificates, utility models and petty patents.
Source: taken from a license agreement between the Spanish National Research Council (“CSIC”, Licensor) and MPP (Licensee) (acting in its role as the “implementing arm” of the World Health Organization’s COVID-19 Technology Access Pool (“C-TAP”)). Partner types: multilateral, public research institution; Product type: COVID-19 vaccine; Development stage at signature: preparation for phase I clinical trial. Read in context.
Licensed Technology means the Licensed Patents and the Licensed Know–how.
Related definitions:
- “Licensed Know–how” means any and all technical information or know–how (including, without limitation, all manufacturing data, the percentages and specifications of ingredients, the manufacturing process, specifications, assays, quality control and testing procedures) that is reasonably necessary for the making of the Final Products and: (i) was developed by [Licensor] by or under the direction of the Principal Investigator on or before the Effective Date; or (ii) is generated by[Licensor] by or under the direction of the Principal Investigator or acquired by[Licensor] after the Effective Date.
- “Licensed Patents” means any and all patents and patent applications filed by[Licensor] either before, on, or after the Effective Date describing: (i) the drug combination nanoparticle platform technology; (ii) the long–acting formulations used in the Final Products; or (iii) any other intellectual property reasonably necessary for the making of the Final Products; where each of (i), (ii) and (ii) were developed by or under the direction of the Principal Investigator. For information purposes only, a list of patents and patent applications relevant to the Final Products which have been granted or filed as at the Effective Date, and which[Licensor] expects to file after the Effective Date, is attached to this Agreement in Schedule 1. The Licences Patents include the the patents and patent applications referred to above as may be amended from time to time, including any continuations, continuations in part, extensions, reissues, divisions, and any supplementary protection certificates and similar rights deriving priority from any of these.
Source: taken from a patent and know-how license between the University of Washington (Licensor) and the Medicines Patent Pool (Licensee). Partner types: multilateral, academic institution; Product type: HIV therapeutic (long-acting injectable); Development stage at signature: pre-clinical. Read in context.
Licensed Technology means the Licensed Manufacturing Know-How, and the Licensed Patents.
Related definitions:
- “Licensed Manufacturing Know-How” means all Know-How that (a) is Controlled by [Licensor] or any of its Affiliates as of the Effective Date, (b) is Developed by [Licensor] during the Term of this Agreement, and (c) directly relates to the fill & finish Manufacture of the [Licensor] Product but does not include the Know-How relating to [Licensor] Drug Substance and/or related processes. The detailed scope of the Licensed Manufacturing Know-How is defined in the Technology Transfer Agreement.
- “Licensed Patents” means i) the patents listed in Annex 2 of this Agreement and ii) any other future patents that may be filed during the Term of this Agreement by [Licensor] both i) and ii) in as far they are related to the Licensed Manufacturing Know-How.
Source: taken from a license agreement between Valneva (Licensor) and Serum Institute of India (Licensee). Partner types: industry; Product type: chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.
Permitted activities
License agreements sometimes grant broad rights to the licensee to develop, manufacture, commercialize and otherwise exploit the licensed IP in the licensed field and territory. However, agreements can also specify restrictions on the licensee’s use of the licensed rights. In these cases, it is important that the scope of permitted activities is aligned with the goals of each party to the agreement as well as taking into account applicable national laws (e.g., statutory research and experimental use exceptions), and the provisions of the TRIPS agreement.
Considerations for establishing the parameters of permitted activities may include:
Whether the licensee is permitted to manufacture and sell drug substance, finished drug product, or both;
Whether the license agreement is only intended to cover limited development and/or commercialization activities;
Whether the licensee may grant sublicenses to third parties, and any specific conditions for doing so (for example, pass through of obligations to the sublicensee, ability of the sublicensee to meet certain requirements);
Whether the licensee’s use of any technology transferred should be restricted to specified facilities that have been inspected and validated for quality standards;
Permitted channels for the licensee to source raw materials or API for manufacturing the licensed product; and
Permitted channels for the licensee’s sales of the licensed product (for example, through resellers/distributors or directly to specified procurement agencies).
Examples from the MAPGuide
Subject to all the terms and conditions of this Agreement, [Licensor] hereby grants to Licensee an exclusive license, under the Licensed Patents, with the right to sublicense through multiple tiers, to make, have made, use, have used, offer for sale, have offered for sale, sell, have sold, import, have imported, export or have exported Licensed Patents, and to practice any Licensed Method, within the Field in the Licensed Territory (the “License”).
Source: taken from a license agreement between Yale University (Licensor) and BIND Biosciences (Licensee) for the development and commercialization of licensed products and methods for the treatment of cancer. Partner types: academic institution, industry; Product type: cancer treatment; Development stage at signature: unknown. Read in context.
[Licensor] grants a non-exclusive, non-transferable licence to [Licensee] of [Licensor]’s Intellectual Property Rights in the Product with the right to sub-license to the Centres, solely for the purpose of using the Product in the Phase III Clinical Trial of the Programme at the Centres in the Field pursuant to the Protocol.
Source: taken from a license and collaboration agreement between the UK Medical Research Council and Indevus. Partner types: industry, non-profit research institution; Product type: microbicide for the prevention of HIV infection; Development stage at signature: phase 3 clinical trial. Read in context.
Transfer Recipient] shall not, without the prior written consent of [Transferor] directly or indirectly (a) disclose or otherwise make available the [Transferor] Technology, nor assign, transfer, license, or sublicense any rights obtained by [Transfer Recipient] hereunder, to any Affiliate or Third Party, (b) use the [Transferor] Technology for research or development, (c) Manufacture or Commercialize Products in any facility or plant other than the Facilities or through any unit of [Transfer Recipient] other than [specified unit], nor (d) other than for the Products, use the [Transferor] Patents Rights or [Transferor] Technology in connection with any pharmaceutical products (including any successor or alternative delivery, presentations or dosing regimens of the Product).
During the Term, Transfer Recipient shall not directly or indirectly market, promote, supply, distribute, offer for sale, sell or otherwise exploit any other products that, in [Licensor]’s good faith judgment may compete with the Product.
Source: taken from a technology transfer and supply agreement between Protalix (Transferor) and Fiocruz (Transfer Recipient). Partner types: industry, state-owned manufacturer; Product type: Gaucher Disease therapeutic; Development stage at signature: licensed product. Read in context.
Upon the terms and subject to the conditions set out in this Sublicense Agreement, [Sub-Licensor] hereby grants to the Sublicensee, and the Sublicensee hereby accepts, a nonexclusive, non-sublicensable, royalty-free, non-transferable license under the Sublicensed Rights and the Sublicensed Manufacturing Know-How to Manufacture the Licensed Compound and Licensed Product at the Facility(ies) exclusively for sale to Customers for use and distribution in the Field in the Territory and to obtain Manufacturing Approvals, strictly in accordance with this Sublicense Agreement and the Sublicense Access Plan.
Related definitions:
- “Customer” means each customer, whether a Commercial Sublicensee or [Sub-Licensor], with which the Sublicensee has entered into a Supply Agreement for the manufacture and/or supply of Licensed Product.
- “Commercial Sublicensee” means any Person that has been approved by [Head Licensor] and [Sub-Licensor] to Commercialize Licensed Product in one or more countries in the Territory and with which [Sub-Licensor] has entered into a commercial sublicense agreement (each a Commercial Sublicense Agreement). For clarity, the Sublicensee may also be a Commercial Sublicensee if and when it enters into a Commercial Sublicense Agreement with [Sub-Licensor]. Commercial Sublicense means the commercial sublicense granted to a Commercial Sublicensee under a Commercial Sublicense Agreement.
Source: taken from a sublicense agreement between GARDP (Sublicensor) and Orchid Pharma (Sublicensee) related to a head license between GARDP and Shionogi (Head Licensor). Partner types: PDP, industry; Product type: antibiotic (cefiderocol); Development stage at signature: licensed product on WHO EML. Read in context.
Subject to terms and conditions of this Agreement, [Licensor] hereby grants to [Licensee] an exclusive, sub-licensable, and profit sharing license to use the Licensed Technology solely together with the [Licensor] Drug Substance supplied by [Licensor] to Develop, Manufacture Commercialize and otherwise Exploit, either through [Licensee] directly or through its pre-approved Sub-licensees or Subcontractors, the [Licensee] Product, in the [Licensee] Territory in the Field during the Term of this Agreement (“Commercial License“). For clarification, the license granted as it relates to the use of [Licensor]’s regulatory dossier (“Dossier“) is restricted to the limited use necessary for regulatory purposes.
Source: taken from a license agreement between Valneva (Licensor) and Serum Institute of India (Licensee). Partner types: industry; Product type: chikungunya vaccine; Development stage at signature: phase 3 clinical trials. Read in context.
Subject to the terms and conditions of this Agreement and to the extent to which the Licensor has the right to grant a licence in respect of the Patent Rights, the Licensor hereby grants to the Licensee a non-exclusive, royalty-bearing (in relation to Royalty Countries), non-sublicensable (other than to Approved Affiliates and Approved Local Distributors in accordance with Clauses [x] below), non-transferable licence of the Patent Rights, to the extent necessary, to:
- obtain Regulatory Approval for Licensed Product;
- manufacture, sell, or otherwise supply Licensed Product solely for use in the Field in the Permitted Market; and
- sell or otherwise supply Licensed Compound to a [Product] Licensee for use under a [Product] Licence.
Source: taken from a license agreement between ViiV Healthcare (Licensor) and MPP (Licensee). Partner types: industry, multilateral; Product type: long-acting PrEP (cabotegravir); Development stage at signature: US FDA approval. Read in context.
During the Term, except pursuant to and in accordance with the terms of this Agreement, neither [Licensee] nor any of its Affiliates shall directly or indirectly develop, manufacture or commercialize any therapeutic product containing an antibody as an active ingredient in the Licensed Territory that is indicated for the treatment of [disease] infections in humans. [Licensor] acknowledges that [Licensee], as of the Effective Date, has existing development programs and activities with respect to treatments of [disease], and, notwithstanding anything to the contrary herein, except as set forth above in this Section [x], this Agreement shall not in any way restrict [Licensee]’s freedom to exploit any product opportunities or to conduct development or commercialization activities, now and in future, against [disease] either by way of preventive products, curative products or therapeutic treatments.
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.
Subject to the terms and conditions of this Agreement, the [Licensee] has the right to grant sublicenses of any or all of the rights granted to it under Section [x] to (a) its Affiliates, and (b) partners and contractors to conduct activities in furtherance of the Development, Manufacture, and Commercialization of the Licensed Products in the Licensed Field, and with respect to Commercialization, in the Territory. Each sublicense shall be subject to a written agreement that is consistent with the terms and conditions of this Agreement, and shall not impose any obligation or liability on [Licensor]. As between the Parties, the [Licensee] remains responsible for compliance with its obligations under this Agreement, including for acts or omissions of its sublicensees that result in a failure to comply with such obligations.
Source: taken from a license agreement between Atreca, Inc (Licensor) and Gates Medical Research Institute (Licensee). Partner types: non-profit research institute, industry; Product type: prophylactic malaria mAb; Development stage at signature: pre-clinical. Read in context.
How do the licensed territory and license exclusivity impact the purchasers eligible for affordable pricing commitments, and the potential for generating price competition?
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.
