Glossary of Global Health Agreement Terms

Glossary

GHIAA has developed a glossary of global health agreement terms to facilitate discussion of the varying interpretations of commonly used global health terms. We welcome suggestions of new terms and definitions which are important to the global health policy and transactions community.

This glossary includes definitions of the key terms contained in public health related agreements, policies or publications and is intended to serve as a reference for the common definitions used in global health alliance agreements. The source for each definition is indicated after such definition.

A

"Access" (also: Equitable Access, Global Access, Global Access Objectives)

Access’, ‘Equitable Access’ and ‘Global Access’ are related terms in the context of global health agreements. ‘Access’ may be used in a broader sense of the ability to obtain medicines or healthcare than ‘equitable’ or ‘global’, however some organizations (such as WHO) also link the concept of equity to the definition of access. Based on our research, ‘access’ is not generally a defined term in global health agreements, however it is defined in literature on the subject of access to medicines. Some examples of a definition of access are:

Alternative One: The degree to which services can be obtained within the cost and effort limits that are acceptable to the general population (Global Health Learning Center Glossary).

Alternative Two: The ability to secure a specified set of healthcare services, at a specified level of quality, subject to a specified maximum level of personal inconvenience and cost, while in possession of a specified amount of information (Oliver AMossialos E. “Equity of Access to Health Care: Outlining the Foundations for Action.” )

Alternative Three: The equitable availability and affordability of essential medicines during the process of medicine acquisition. Lack of access is generally understood to mean the absence of available and affordable treatment options for the patient. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).

The terms ‘equitable access’ and ‘global access’ often incorporate reference to affordability and availability of medical products. Different organizations may prefer one term over the other, for example CEPI funding agreements refer to Equitable Access, whereas agreements with the Bill & Melinda Gates Foundation refer to Global Access and associated Global Access Objectives. Some examples of definitions for these terms are:

“Equitable Access”

Alternative One: Equal access for equal need. (Thiede, Michael, and Di McIntyre. “Information, Communication and Equitable Access to Health Care: a Conceptual Note.” Cadernos De Saúde Pública, vol. 24, no. 5, 2008, pp. 1168–1173).

Alternative Two: A [product] is available first to populations at risk when and where they are needed at affordable prices. (CEPI – Novavax, COVID-19 Vaccine Funding Agreement, §14.1).

“Global Access” Making the products and information generated by the foundation funding widely available at an affordable price, in sufficient volume, at a level of quality, and in a time frame that benefits the people. (Gates Foundation, Global Access).

“Global Access Objectives”

Alternative One: The objectives to provide funding to support the development of drugs and vaccines to address diseases that have a disproportionate impact on people within developing countries, and to ensure that such products can be made available and accessible at reasonable cost and with all due speed to people within developing countries. (Gates Foundation and Visterra Strategic Relationship Letter Agreement).

Alternative Two: The objectives (a) to improve the processes and technologies for the development, manufacture and delivery of Products for use in the Field, with the aim of making them more available and more accessible in terms of cost, quantity and quality to people most in need in the Developing Countries; and (b) to ensure that information and data resulting from activities under the Project are promptly and broadly disseminated – without jeopardizing intellectual property protection – to the relevant scientific and educational communities. (Academic Institution – Company, Research Collaboration Agreement, §1.13).

"Affected Territory"

The geographic area of any country (i) where there is an Outbreak; (ii) for which there is an Increased Outbreak Preparation Need; or (iii) the Parties otherwise agree in writing and in each case, including healthcare workers providing healthcare in such a country regardless of their home country. (Unattributed Funder Development Partnering Agreement, §1.1.2 ).

Also see the definitions of “Outbreak” and “Increased Outbreak Preparation Need.”

"Affordability"

The cost in relation to peoples’ income. [For the purpose of the specific WHO glossary quoted here,] the daily wage of the lowest-paid unskilled national government worker is used for comparison with the cost of a defined course of treatment for a specific condition. (WHO Access to Medicines Glossary).

Also see the definitions of “Affordable Pricing” and “Equitable Pricing.”

"Affordable Pricing"

The lowest sustainable, competitive price for the Product(s) which covers the cost of raw materials, manufacturing, distribution and operational overheads, and includes a reasonable margin to help ensure the economic sustainability of the production and distribution of the Product(s). (Medicines Patent Pool and Pfizer Sutezolid License Agreement, §3.3).

Also see the definitions of “Affordability” and “Equitable Pricing.”

B

"Background"

Alternative One: Information, including data and know-how which is held by participants prior to the accession to this agreement, as well as copyrights or other intellectual and industrial property rights pertaining to such information, and which is necessary for carrying out the project and identified in the project agreement. (IMI 1 JU Model Grant Agreement, §II.1).

Alternative Two: Any data, know-how or information – whatever its form or nature (tangible or intangible), including any rights such as intellectual property rights – that: (a) is held by the beneficiaries before they acceded to the Agreement, and (b) is needed to implement the action or exploit the results. (IMI 2 Model Grant Agreement, §24.1).

Alternative Three: Any information, data, techniques, Know-how, inventions, software, discoveries and materials (regardless of the form or medium in which they are disclosed or stored) which are provided by one Party (whether belonging to that Party or to a third party) to another Party for use in the Project, and whether before or after the date of this Agreement, except any Result. (Lambert Toolkit Model Consortium Agreement D, §1.1).

Also see the definitions of “Background Intellectual Property (IP)”, “Background Technology” and “Essential Background Technology.”

"Background Intellectual Property" (also: Background IP)

Alternative one: Any Intellectual Property owned or controlled by a party at the Effective Date or which a party develops or acquires independently of the work under the Project, in each case, which is necessary or useful for undertaking any Work Phase, or the protection or exploitation of Foreground Intellectual Property. (Unattributed Funder Development Partnering Agreement, §1.1.6).

Alternative two: Intellectual Property owned by a party that already exists at the date of this Agreement or is generated other than through the performance of the Services under this Agreement; for the avoidance of doubt, “Background Intellectual Property” of Customer includes without limitation all Intellectual Property assigned or transferred to the Customer under the IP Assignment. (Qinetiq Ltd and Integral Systems Inc Agreement for the Provision of Services).

Also see the definitions of “Background,” “Background Technology,” and Essential Background Technology“.

"Background Technology"

Any and all products, services, processes, technologies, materials, software, data, or other innovations, and intellectual property created by You (grantee) or a third party prior to or outside of the Project used as part of the Project. (Gates Foundation Global Access Commitment and Humanitarian License Clauses).

Also see the definitions of “Background”, “Background Intellectual Property” and “Essential Background Technology”.

"Best Reasonable Efforts"

(a) In the case of [Contractor], the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as [Contractor] would undertake or use in the development and manufacture of a Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and (b) in the case of the [Government Entities], the activities and degree of effort that governments would undertake or use in supporting their contractor in the development of the Vaccine having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world. (European Union and AstraZeneca Advance Purchase Agreement, §1.9).

C

"Commercial Sale" (also: Commercial Sales)

Any sale of a Licensed Product or a Licensed Combination Product to a Third Party in any country in the Territory in the Field; provided, however, that a transfer of Licensed Products or Licensed Combination Products (i) for research and development purposes, or (ii) prior to receipt of Product Approval for use of such Licensed Product or Licensed Combination Product in humans, shall not be considered a Commercial Sale. (“Product Approval” means the grant of all necessary regulatory and governmental approvals required to manufacture, use, store, import, export, transport and/or sell Licensed Products or Licensed Combination Products in any country of the Territory). (Supernus and United Therapeutics Exclusive License Agreement, §1.1 ).

"Commercialization" (also: Commercialize, Commercializing)

Alternative One: Any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Product, including activities related to marketing, promoting, distributing, and importing such Licensed Product, and interacting with regulatory authorities regarding any of the foregoing. (AbbVie and Medicines Patent Pool License Agreement, §1.4 ).

Alternative Two: Any and all activities directly and specifically relating to marketing, promoting, detailing, distributing, importing, offering for sale, having sold and/or selling a Licensed Product in the Field in the Territory, but excluding Development and Manufacturing. (ZP Opco and Eli Lilly Collaboration, Development and License Agreement, Appendix 1.1).

Also see the definition of “Commercialization Plan.”

"Commercialization Plan"

A confidential plan, no later than [six (6) months] after the first approval of the Product, describing the Targeted Territories to commercialize the Product. (CARB-X Research Subaward Agreement, §6.04).

Also see the definition of “Commercialization.”

"Commercially Reasonable Efforts"

The efforts and resources that a similarly situated [company] or [institution], as applicable, would use for its own internally discovered [technology] of similar commercial potential and similar stage of development, taking into consideration the likely timing of [the technology’s] entry into the market, any patent and other proprietary position and issues of safety and efficacy. (Trustees of the University of Pennslyvania and BioNTech Pharmaceuticals GMBH Collaboration & License Agreement, §1.20).

"Compulsory License" (also: Compulsory Licenses)

Alternative One: An authorization granted by a government to someone other than the patent-holder to produce the product without the patent-holder’s consent. (Bond, Eric, and Kamal Saggi. “Compulsory Licensing, Price Controls, and Access to Patented Foreign Products.” Protecting Traditional Knowledge, Apr. 2012.)

Alternative Two: The grant of permission for an enterprise seeking to use another’s intellectual property without the consent of its proprietor. (Compulsory Licensing of Patented Inventions, Congressional Research Service report).

Alternative Three: When a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. It is one of the flexibilities in the field of patent protection included in the WTO’s agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement. (WTO Compulsory Licensing of Pharmaceuticals and TRIPS FAQs).

Alternative Four: Any valid, bona fide compulsory license pursuant to (a) the requirements promulgated under the Agreement or (b) valid laws within such country for any Product. (Gilead HCV License Agreement with Indian Generic Manufacturers, §2.1).

"Confidential Information"

Alternative One: All trade secrets, processes, formulae, data, know-how, improvements, inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information that has been created, discovered, or developed by a Party or any of its Affiliates, or has otherwise become known to a Party or any of its Affiliates, as well as any other information and materials that are deemed confidential or proprietary to or by a Party or any of its Affiliates (including all information and materials of a Party’s (or its Affiliates’) customers and any other Third Party and their consultants), regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic or electronic form. Confidential Information will include the Licensed Manufacturing Know-How. (Medicines Patent Pool and Bristol-Myers Squibb Company License and Technology Transfer Agreement, §1.1).

Alternative Two:  Any and all proprietary Know-How, information and data, including scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by or on behalf of one Party to the other Party and/or its Affiliate in connection with this Agreement. (D3, Biomedical Sciences Institutes and Visterra Agreement for Research Collaboration, §1 ).

Alternative Three: Information, data or material in writing, that the Disclosing Party has prominently marked or otherwise prominently identified as confidential or proprietary in nature. (Aridis and PATH Vaccine Solutions Formulation Development Agreement, §7.1).

Alternative Four: Subject to Section ____, (a) all information provided at any _____ related meeting with respect to any aspect of the Project, regardless of whether or not such information is identified or marked as confidential and regardless of whether or not a written record is subsequently provided if the information was provided orally, and (b) all recorded information, including data marked “Confidential” or bearing a similar legend. (CAVD Data & Materials Sharing Agreement, Annex D).

D

"Data Exclusivity"

The data generated by the holder may not be referred to or used by another person or company for a specific period of time. (WHO, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity).

"Developing Countries"

Alternative One: Those countries identified by the World Bank […] as having “low income economies,” or “lower-middle income economies” or “upper-middle income economies” […] as may be amended from time to time by the World Bank. (PATH – Aridis, Rotavirus Vaccine Development Agreement, §1.5).

Alternative Two: The countries that are eligible for GAVI support as of the Effective Date based on a Gross National Income (GNI) per capita below or equal to US $ 1,570 (identified at http://www.gavi.org/Support/Apply/Countries-eligible-for-support/) […]. (Academic Institution – Company, Research Collaboration Agreement, §1.9).

"Development"

All activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of applications to regulatory authorities, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a regulatory authority as a condition or in support of obtaining or maintaining a regulatory approval. When used as a verb, “Develop” means to engage in Development. (AbbVie and Medicines Patent Pool License Agreement, §1.5).

E

"Epidemic"

The occurrence of more cases of disease, injury, or other health condition than expected in a given area or among a specific group of persons during a particular period. Usually the cases are presumed to have a common cause or to be related to one another in some way. (Principles of Epidemiology in Public Health Practice: An Introduction to Applied Epidemiology and Biostatistics. 3rd ed., U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), Office of Workforce and Career Development, 2012).

"Equitable Access"

Alternative One: Vaccines, medicines and other products developed, in whole or in part, often with public financial support must be first available to populations when and where they are needed to end an outbreak or manage a disease, regardless of ability to pay, while at a price that is sustainable to the manufacturer. (Huneycutt, Brenda, et al. “Finding Equipoise: CEPI Revises Its Equitable Access Policy.” Vaccine, vol. 38, no. 9, 2020, pp. 2144–2148).

Alternative Two: Equal access for equal need. (Thiede, Michael, and Di McIntyre. “Information, Communication and Equitable Access to Health Care: a Conceptual Note.” Cadernos De Saúde Pública, vol. 24, no. 5, 2008, pp. 1168–1173).

Alternative Three: All individuals have access to affordable, high-quality, culturally and linguistically appropriate care in a timely manner. (Latino Coalition for Healthy California, Equitable Health Care Access).

Also see the definitions of “Access,” “Global Access,” and “Global Access Objectives.”

"Equitable Pricing" (also: Differential Pricing)

The adaptation of prices that are charged by the manufacturer or seller to countries with different purchasing power. (WHO, Equitable Access to Essential Medicines: A Framework for Collective Action).

Also see the definition of “Affordability” and “Affordable Pricing

"Essential Background Technology"

Background Technology that is (i) owned, controlled, or developed by [the grantee], or in-licensed with the right to sublicense; and (ii) either incorporated into a Funded Development or reasonably required to exercise the license to Funded Developments. (Gates Foundation Global Access Commitment and Humanitarian License Clauses).

Also see the definitions of “Background,” “Background Intellectual Property (IP),” “Background Technology,” and  “Humanitarian License.”

"Exploit" (also: Exploitation)

To make, have made, import, use, sell, or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market, or have sold or otherwise dispose of. (AbbVie and Medicines Patent Pool License Agreement, §1.6).

F

"Field"

Alternative One: With respect to a particular Product, any use that is consistent with the label approved by the FDA or applicable foreign regulatory authority in the country of sale for the therapeutic use of such Product. (Medicines Patent Pool and Gilead Amended and Restated License Agreement, §1.6).

Alternative Two: The treatment or prevention of HIV which does not include the treatment or prevention of other viruses, including without limitation HCV. (AbbVie and Medicines Patent Pool License Agreement, §1.7).

Alternative Three:  The treatment of any and all therapeutic indications and uses. (Supernus and United Therapeutics Exclusive License Agreement, §1.1).

Alternative Four: [Pediatric treatment] or prevention of disease or other therapeutic area. (AbbVie and Medicines Patent Pool License Agreement, 1.7).

"Foreground"

The results, including data, know-how and information, whether or not they can be protected, which are generated under the project and excluding Sideground. (IMI 1 Model Grant Agreement, §II.26.1).

Also see the definitions of “Foreground Intellectual Property,” “Program Know-How,” “Project Invention,” “Project Intellectual Property,” “Project Patents,” “Project Results,” and “Results.”

"Foreground Intellectual Property" (also: Foreground IP)

Alternative One:  Any Intellectual Property (including the Project Patents and Project Inventions) arising out of the undertaking and performance of any Work Phase of the Project. (Unattributed Funder Development Partnering Agreement, §1.1.35).

Alternative Two: Intellectual Property arising out of the performance of the Services under this Agreement (but for the avoidance of doubt excluding Background Intellectual Property). (Qinetiq and Integral Systems Agreement for the Provision of Services, §1.1).

Also see the definitions of “Foreground,” “Program Know-How,” “Project Invention,” “Project Intellectual Property,” “Project Patents,” “Project Results,” and “Results.”

"Funded Development" (also: Funded Developments)

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). (Gates Foundation Global Access Commitment and Humanitarian License Clauses).

G

"Gavi-Eligible Country"

A country whose three-year average Gross National Income (GNI) per capita is equal to or below the Eligibility Threshold. A Gavi-eligible country is either a Low-Income Country or a Phase 1 Country. (Gavi Alliance Eligibility and Transition Policy, §4.4). 

Note: Gavi’s GNI per capita threshold for eligibility was set at an amount of US $1,500 in 2011. The GNI threshold amount for Gavi is updated annually to account for inflation and published on the Gavi website following the annual release of updated GNI p.c. estimates by the World Bank. “Phase 1 Country” means a Gavi-eligible country whose GNI per capita is above the Low Income Country threshold and whose average GNI per capita of the previous three years is equal to or below the Eligibility Threshold.

"Global Access"

Alternative One: Requires that grantees and partners commit to making the products and information generated by the foundation funding widely available at an affordable price, in sufficient volume, at a level of quality, and in a time frame that benefits the people. (Gates Foundation, Global Access).

Alternative Two: 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. (Gates Foundation Global Access Commitment and Humanitarian License Clauses).

Also see the definitions of “Access,” “Equitable Access,” and “Global Access Objectives.”

"Global Access Objectives"

Alternative One: The objectives to provide funding to support the development of drugs and vaccines to address diseases that have a disproportionate impact on people within developing countries, and to ensure that such products can be made available and accessible at reasonable cost and with all due speed to people within developing countries. (Gates Foundation and Visterra Strategic Relationship Letter Agreement).

Alternative Two: Projects will be conducted and managed – along with the resulting products, services, processes, technologies, materials, software, data or other innovations – in a manner that ensures “Global Access.” (Global Health Vaccine Accelerator Platforms Data Sharing Guiding Principles).

Alternative Three: The objectives (a) to improve the processes and technologies for the development, manufacture and delivery of Products for use in the Field, with the aim of making them more available and more accessible in terms of cost, quantity and quality to people most in need in the Developing Countries; and (b) to ensure that information and data resulting from activities under the Project are promptly and broadly disseminated – without jeopardizing intellectual property protection – to the relevant scientific and educational communities. (Academic Institution – Company, Research Collaboration Agreement, §1.13).

"Global Health"

The transnational impacts of globalization upon health determinants and health problems which are beyond the control of individual nations. (WHO Health Promotion Glossary: New Terms).

"Global Trade Control Laws"

The U.S. Export Administration Regulations; the U.S. International Traffic in Arms Regulations; the U.S. economic sanctions rules and regulations implemented under statutory authority and/or the President’s Executive Orders and administered by the U.S. Department of the Treasury Office of Foreign Assets Control; European Union (E.U.) Council Regulations on export controls, including Nos.428/2009, 267/2012; other E.U. Council sanctions regulations, as implemented in E.U. Member States; United Nations sanctions policies; all relevant regulations and legislative instruments made under any of the above; other relevant economic sanctions, export and import control laws, and other laws, regulations, legislation, orders and requirements imposed by a relevant governmental entity.

H

"Humanitarian License"

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. (Gates Foundation Humanitarian License FAQs).

Also see the definition of  “Public Health License.”

I

"Improvements" (also: Improvement)

Alternative One: Any and all improvements, enhancements or modifications, patentable or otherwise, relating to the Compound or Licensed Products or Licensed Combination Products including, without limitation, any change or modification in the manufacture, formulation, analytical methodology, ingredients, preparation, presentation or means of delivery, administration or dosage of the Compound or Licensed Products or Licensed Combination Products. (Supernus and United Therapeutics Exclusive License Agreement, §1.1).

Alternative Two: All improvements, methods, modifications and other know-how developed by or on behalf of a Licensee and relating to a Product. (Medicines Patent Pool and Gilead Amended and Restated License Agreement, §11).

"Intellectual Property" (also: IP, Intellectual Property Rights, IP Rights)

Alternative One: All intellectual property rights arising from or associated with the following, whether created, protected or arising under the laws of the United Kingdom or any other jurisdiction:

(a) trade names, trademarks and service marks (whether registered or unregistered), domain names and other internet addresses or identifiers, trade dress and similar rights and applications to register any of the foregoing (collectively, “Marks”);

(b) patents and patent applications and rights in respect of utility models or industrial designs (collectively, “Patents”);

(c) copyrights (whether registered or unregistered) and registrations and applications therefor (collectively, “Copyrights”);

(d) know-how, inventions, discoveries, methods, processes, techniques, methodologies, formulae, algorithms, technical data, specifications, research and development information, technology, data bases and other proprietary or confidential information, including customer lists, in each case that derives economic value (actual or potential) from not being generally known to other persons who can obtain economic value from its disclosure, but excluding any Copyrights or Patents that cover or protect any of the foregoing (collectively, “Trade Secrets”); and

(e) any other proprietary, intellectual or industrial property rights of any kind or nature that do not comprise or are not protected by Marks, Patents, Copyrights or Trade Secrets. (Qinetiq and Integral Systems Agreement for the Provision of Services, §1.1).

Alternative Two: Any or all of the following and all rights in, arising out of, or associated therewith:

(i) all United States and foreign patents and utility models and applications therefor and all reissues, divisions, renewals, reexaminations, extensions, provisionals, continuations and continuations-in-part thereof, and equivalent or similar rights anywhere in the world in inventions, disclosures, and discoveries, whether or not patentable, and whether or not reduced to practice (“Patents”);

(ii) all trade secrets, know-how, proprietary information, technical data, improvements, technology, computer programs (in source code and executable code form, and whether embodied in software, firmware or otherwise), documentation (including software documentation), drawings, designs, flow charts, specifications, logic diagrams, programmer notes, protocols, files, records, databases, formulae, compositions, processes, manufacturing and production processes and techniques, research and development information, improvements, proposals, and technical data (“Technical Information”);

(iii) all copyrights, works of authorship, copyright registrations and applications therefor and all other rights corresponding thereto throughout the world (“Copyrights”);

(iv) all industrial designs and any registrations and applications therefor throughout the world;

(v) any similar, corresponding or equivalent rights to any of the foregoing anywhere in the world, including but not limited to computer program rights and registrations and applications therefor; and

(vi) all copies and tangible embodiments of the foregoing (in whatever form or media). (Intersil and ChipPAC Intellectual Property Rights Agreement, §1.3).

Alternative Three: All rights in Copyrights, Patents, Mask Works, Trademarks, Technology and any other proprietary rights relating to intangible property anywhere in the world, and all registrations and applications related to any of the foregoing and analogous rights thereto anywhere in the world. (Motorola and Freescale Semiconductor Intellectual Property Assignment Agreement, §1.12).

Alternative Four: Means any worldwide intellectual property or other proprietary rights (excluding trademark, service mark, and domain name rights), including but not limited to copyrights, trade dress rights (including audible characteristics), mask work rights registrations, moral rights, patent rights, patent applications and disclosures, know-how, inventions, rights of priority, and trade secret rights. (TGC, Tivo Intl II, and Tivo Intellectual Property and Technology Agreement, §1.63).

Alternative Five: patents, patent applications, inventions, Know-how, trade secrets and other confidential information, rights in design (registered and unregistered), copyright (including, without limitation, rights in computer software), data, database rights and sui generis rights, rights affording equivalent protection to copyright, semiconductor topography rights, trade marks, service marks, logos, domain names, business names, trade names, brand names, certification marks, assumed names and other indicators or origin, rights in any drawings, designs, plans, specifications, manuals, computer software, assets, inventor’s certificates and invention disclosures, writings and other works, whether copyright or not, bills of material, moral rights and all other industrial or intellectual property or other rights or forms of protection of a similar nature or having similar effect in any part of the world and rights in and in relation to them and, where appropriate, applications for any of them in any country or jurisdiction, rights in the nature of unfair competition rights, rights to sue for passing-off, the right to apply for any of them and all other information necessary for the technical exploration of any of the same and all registrations. (Forfás, Template Collaboration Agreements).

"Investigational Product" (also: Investigational Products)

A product that has not received marketing approval. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, §14).

K

"Know-how" (also: Know-How)

Any unpatented, unpublished, technical information (including, without limitation, information relating to inventions, discoveries, concepts, methodologies, models, research, development and testing procedures, the results of experiments, tests and trials, manufacturing processes, materials, formulae, formulations, processes, research or experimental results, techniques and specifications, quality control data, analyses, reports and submissions) that is not in the public domain. (Forfás, Template Collaboration Agreements).

L

"Least Developed Countries" (also: Least Developed Country)

Alternative One: A list of developing countries that, according to the United Nations, exhibit the lowest indicators of socioeconomic development, with the lowest Human Development Index ratings of all countries in the world. (United Nations, General Assembly Twenty-Sixth Session (1971)).

Alternative Two: The countries listed on the United Nations List of Least Developed Countries. (UNCTAD, UN List of Least Developed Countries).

Also see the definitions of “Developing Nations” and “Low and Middle Income Countries.”

"License"

Alternative One: A contract in which the [IP] holder allows another party to use the IP, either in return for a payment of royalties (or some other consideration, such as marketing of the product or access to the other party’s assets) or free of charge, for a certain field of use, in a certain territory (which may be for the life of the patent). (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).

Alternative Two: A standard license arrangement is one under which one person (the licensor), who is the owner of a right to prevent other persons from commercially exploiting or using certain intellectual creations (e.g. inventions, designs) or distinctive signs (e.g. marks, trade names), agrees not to exercise that right against a given person (the licensee) in exchange for a fee, and perhaps also subject to the licensor’s control of such commercial exploitation or use. (WIPO, Intellectual Property Handbook, 2004).

"Licensed Manufacturing Know-How"

All technical information and know-how known to 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] as primarily and directly relating to, and reasonably necessary for, the making of the Licensed Products in the same manner that such Licensed Products have been made by [Licensor] prior to the Effective Date. (Medicines Patent Pool and Bristol-Myers Squibb Company License and Technology Transfer Agreement, §1.1).

"Licensed Products" (also: Licensed Product)

Alternative One: Any human pharmaceutical products produced under license from [company] and/or [company] in the Field and containing the Licensed Compound as one of its active ingredients (or as its sole active ingredient), in finished form or in such other forms, presentations, doses and formulations. (Medicines Patent Pool and Bristol-Myers Squibb Company License and Technology Transfer Agreement, §1.1).

Alternative Two: Pharmaceutical compositions comprised of the Compound as the therapeutically active ingredient and which uses or is developed or manufactured using or in connection with the [licensed] Intellectual Property. (Supernus and United Therapeutics Exclusive License Agreement, §1.1).

"Licensee"

One to whom or to which a license is granted. (Your Dictionary, Licensee).

"Licensor"

One who grants a license. (Your Dictionary, Licensor)

"Low and Middle Income Countries" (also: LMICs, Low and Middle Income Country, LMIC)

Those countries defined by the Organisation for Economic Co-operation and Development as low and middle income countries based on gross national income (GNI) per capita as published by the World Bank. (OECD, DAC List of ODA Recipients).

Also see the definitions of “Developing Nations” and “Least Developed Countries.”

M

"Manufacture"

All activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, and holding of the Licensed Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance, and quality control. (AbbVie and Medicines Patent Pool License Agreement, §1.10).

"Marketing Authorization"

An official document issued by a regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. (WHO Access to Medicines Glossary).

Also see the definition of “Regulatory Approval.”

"Marketing Exclusivity"

A fixed period of time following drug approval during which the sponsor can market their drug without direct competition from manufacturers of duplicate or reformulated products. (Burch, Brandon. “Types of Marketing Exclusivity in Drug Development.” Nuventra, 2019.)

N

"Net Sales"

Alternative One: with respect to a given calendar quarter, the total amount invoiced by a Sublicensee for sales of the Licensed Products in the countries within the Territory where Licensed Patents Rights are in force, less freight, insurance, packing, shipping and custom duty, VAT, excise tax, sales tax, and packing for shipment, to the extent consistent with generally accepted accounting principles as consistently applied across all products of the Sublicensee and in line with the deductions reasonably expected in the relevant market. (Medicines Patent Pool and Bristol-Myers Squibb Company License and Technology Transfer Agreement, §1.1).

Alternative Two: the gross consideration invoiced or received by Licensee or any of its Affiliates or Sublicensees for Sales of Licensed Product (including any cash amounts plus the fair market value of any other forms of consideration), less the following deductions (to the extent included in and not already deducted from the gross amounts invoiced or otherwise charged) to the extent reasonable and customary and solely related to the sale of the Licensed Product:

  • trade discounts, including trade, cash and quantity discounts or rebates, credits or refunds;
  • allowances or credits granted upon claims, returns or rejections of products, including recalls, regardless of the party requesting such recall;
  • charges included in the gross sales price for freight, insurance, transportation, postage, handling and any other charges relating to the sale, transportation, delivery or return of such Licensed Product;
  • customs duties, sales, excise and use taxes and any other governmental charges (including value added tax) actually paid in connection with the transportation, distribution, use or sale of such Licensed Product (but excluding what is commonly known as income taxes);
  • rebates and chargebacks or retroactive price reductions made to federal, state or local governments (or their agencies), or any Third Party payor, administrator or contractor, including managed health organizations; and
  • payments required by law to be made under Medicaid, Medicare or other government special medical assistance programs (including, but not limited to, payments made under the new “Medicare Part D Coverage Gap Discount Program” and the “Annual Fee on Branded Pharmaceutical Manufacturers”, specific to the Licensed Product for which the deduction is taken).

Even if there is overlap between any of deductions described above, each individual item shall only be deducted once in the overall Net Sales calculation. Each of the above deductions to Net Sales shall be calculated in accordance with the Accounting Standards (with the applicable Accounting Standard used clearly indicated on any reports). 

In the event that the Licensed Product is sold as a Combination Product, Net Sales will be determined by multiplying Net Sales of such Combination Product by the fraction A/(A+B), where A is the invoice price of the Licensed Product, when sold separately, and B is the invoice price of any other therapeutically active ingredient(s) in the combination, when sold separately, in each case in the same country and similar class, purity and dosage as in the Combination Product. If, on a country-by-country basis, the Licensed Product or the other therapeutically active ingredient that is not a Product in the Combination Product is/are not sold separately in such country, Net Sales shall be determined by multiplying actual Net Sales of such Combination Product by the fraction C/(C+D), where C is the fair market value of the Licensed Product portion of such combination and D is the fair market value of the other therapeutically active ingredient that is not a Product (such fair market value is to be determined by mutual agreement of the Parties or, in the absence of such mutual agreement, by a neutral Third Party). (Trustees of the University of Pennsylvania and BioNTech RNA Pharmaceuticals Collaboration & License Agreement, §1.46).

O

"Open Access"

The practice of providing online access to scientific information that is free of charge to the end-user and reusable. (EDCTP2 Policy on Clinical Trials Registration, Publication and Data Sharing, §5).

"Open Source Licensing"

The practice of licensing patents, for royalty-free use by third-party users for a specific purpose on the condition that any improvements that are developed are licensed on the same terms. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).

"Originator Pharmaceutical Product" (also: Originator Brand)

A product that was first authorized worldwide for marketing (normally as a patented product) on the basis of the documentation of its efficacy, safety and quality, according to requirements at the time of authorization. (WHO Access to Medicines Glossary).

P

"Pandemic"

An epidemic occurring over a widespread area (multiple countries or continents) and usually affecting a substantial proportion of the population. (Principles of Epidemiology in Public Health Practice: An Introduction to Applied Epidemiology and Biostatistics. 3rd ed., U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), Office of Workforce and Career Development, 2012).

Also see the definition of “Outbreak.”

"Patent Pool"

An agreement between at least two patent owners to group their patent rights relating to a specific technology and to license the rights to use these patents to each other and to third parties, subject to certain conditions, such as the payment of royalties. Pooling the relevant patents necessary to use a technology, or to produce downstream products, allows licensees to enter into only one license agreement with one legal entity. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).

"Patent Rights" (also: Patents)

Alternative One: any and all patents and patent applications in the Territory (which for the purpose of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention), including divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates, and the like of any such patents and patent applications, and foreign equivalents of the foregoing.  (Law Insider Dictionary).

Alternative Two: a title granted by public authorities that confers a temporary monopoly for the exploitation of an invention upon the person who reveals it, furnishes a sufficiently clear and full description of it, and claims this monopoly. (WHO Access to Medicines Glossary).

Alternative Three: an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application. (World Intellectual Property Organisation, About IP, Patents).

"Pharmaceutical Equivalence"

Products with identical amounts of the same active ingredient in the same dosage form and route of administration, that meet the standards of strength, quality, purity and identity. (WHO Access to Medicines Glossary).

"Priority Review Voucher" (also: PRV)

A voucher issued by FDA to the sponsor of a rare pediatric disease product application at the time of the marketing application approval pursuant to section 529 of the Federal Drug and Cosmetic Act, which entitles the holder to designate a single human drug application submitted under section 505(b)(1) of the FDCA or section 351 of the Public Health Service Act as qualifying for a priority review. (Law Insider Dictionary).

Note: Read more about Priority Review Vouchers here. Note that priority review voucher may also apply to products intended to treat tropical diseases or to medical countermeasures to terrorism.

"Project Data"

All data and information, including all clinical study data, produced or arising as a result of the Project. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, §11)

"Project Intellectual Property" (also: Project IP)

Any discoveries, inventions, know-how, patents, trademarks and other forms of intellectual property that arise under the Project. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, §13.2).

Also see the definitions of “Foreground,” “Foreground Intellectual Property,” Project Invention,” “Program Know-How,” “Project Patents,Project Results,” and “Results.”

"Project Invention"

Any discovery, development, Know-How, invention or improvement created, devised or arising out of the undertaking and performance of any Work Phase. (Unattributed Funder Development Partnering Agreement, §1.1.67).

"Project IP Expiration" (also: Project Intellectual Property Expiration)

The expiration of the last patent or exclusivity periods in the United States, the European Union or Japan for any Project IP Rights. (CARB-X Research Subaward Agreement, §5.01(f)(iii)).

"Project Materials"

Biological samples, vaccines (including Product), animal models and other tangible materials produced under the Project [that are shared between the parties under the applicable agreements]. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, §12).

"Project Patents"

Any patent applications made which claim any Project Inventions, any patents resulting from any such applications, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them in all countries, including any divisional applications and divisional patents, refiling, renewals, continuations, continuations-in-part, patents of addition, extensions (including patent term extensions), reissues, substitutions, confirmations, registrations, revalidations, pipeline and administrative protections and additions, and any equivalents of the foregoing in any and all countries of or to any of them, as well as any supplementary protection certificates and equivalent protection rights in respect of any of them. (Unattributed Funder Development Partnering Agreement, §1.1.68).

Also see the definitions of  Foreground,” “Foreground Intellectual Property,” “Project Invention,” “Program Know-How,” “Project IP,” “Project Results” and “Results.”

"Project Results"

The outcomes and results of the Project, may comprise biological samples, data, intellectual property, materials, any Product and Investigational Product, publications, reference standards, technology and other results and shall include all Project IP, Project Data and Project Materials. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, §10.1).

Also see the definitions of “Foreground,” “Foreground Intellectual Property,” “Project IP,” and “Results.”

"Public Health License"

A non-exclusive, fully paid-up, sublicensable and worldwide license under the Project Results and Enabling Rights to develop, manufacture, market and/or supply the Product worldwide; in each case for use in preparation for or response to an Outbreak or Increased Outbreak Preparation Need. For the purposes of this definition, the term “Product” shall mean the [Vaccine] in any form or dosage of pharmaceutical composition or preparation for use in humans. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, Schedule A).

Also see the definition of “Humanitarian License.”

"Publication"

Any written, oral or other public disclosure of Results, including the public use or sale of an invention based on the Results. (Forfás, Template Collaboration Agreements).

R

"Regulatory Approval"

Any technical, medical, scientific or other license, registration, authorization or approval of any Regulatory Authority necessary for the development, manufacture or commercialization of a pharmaceutical product in any regulatory jurisdiction. (Medicines Patent Pool and Pfizer Sutezolid License Agreement, §1.10)

Also see the definitions of “Marketing Authorization,” “Regulatory Authority,” and “Regulatory Documentation.”

"Regulatory Authority" (also: Regulatory Authorities)

Any national or supranational governmental authority that has responsibility in the Territory over the Development and/or Commercialization of the Licensed Compound and Licensed Products. (Medicines Patent Pool and Bristol-Myers Squibb Company License and Technology Transfer Agreement, §1.1).

Also see the definitions of “Regulatory Approval” and “Regulatory Documentation.”

"Results"

Any (tangible or intangible) output of the action such as data, knowledge or information — whatever its form or nature, whether it can be protected or not — that is generated in the action, as well as any rights attached to it, including intellectual property rights. (IMI 2 Model Grant Agreement, §26.1).

Also see the definitions of “Foreground,” “Foreground Intellectual Property,” “Project IP,” and “Project Results.”

S

"Sideground"

Tangible or intangible output generated by a beneficiary under the action, such as data, knowledge and information whatever their form or nature, whether or not they can be protected, but which are outside of the action objectives as defined in this Agreement and which therefore are not needed for implementing the action or for research use of results. (IMI 2 Model Grant Agreement, §26.1)

"Step-in Rights" (also: March-in Rights)

The right of the funder to assume the development and commercialization of the funded products in the event of the actual or anticipated failure by the grantee/developer to develop or commercialize the funded products to ensure access and affordability thereof in the applicable field and territory.

"Stewardship and Access Plan"

When the Product enters Phase III trials, the Subrecipient shall create a plan reasonably describing how it intends to meet the stewardship and access obligations for the Product. The Stewardship and Access Plan shall not include confidential business information and shall include:

(a) Strategy to support access and stewardship (e.g. proposed reliable production with sufficient capacity, supply systems, the broad approach to product labelling, and the broad approach to ensure economic barriers to access are as low as reasonably possible);

(b) Identifying obstacles and constraints to access and stewardship;

(c) Exploitation strategy for Project IP Rights, including whether it is planned for the Project IP Rights to be transferred to a third party;

(d) Strategy to ensure marketing approvals are received for key territories in a timely manner; and

(e) Strategy for monitoring effectiveness of access and stewardship, including proposed metrics to measure success.

(CARB-X Research Subaward Agreement, §5.01).

Note: see the CARB-X Stewardship & Access Plan Guide for further information.

T

"Target Product Profile" (also: TPP)

Outlines the desired “profile” or characteristics of a target product that is aimed at a particular disease or diseases. TPPs state intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. (WHO: Global Observatory on Health R&D).

"Technology Transfer"

Alternative One: Promptly and diligently providing all necessary guidance, information, materials and assistance reasonably required by the [Licensee] to accomplish the activities that may be requested by the Agreement. (Gilead – Indian Generic Manufacturers, HCV License Agreement, §5.5).

Alternative Two: Broadly stated, means a series of processes for sharing ideas, knowledge, technology and skills with another individual or institution (e.g., a company, a university or a governmental body) and of acquisition by the other of such ideas, knowledge, technologies and skills. In the context of transferring technologies from the public sector and universities to the private sector, the term “transfer of technology” is sometimes used in a narrower sense: as a synonym of “technology commercialization” whereby basic scientific research outcomes from universities and public research institutions are applied to practical, commercial products for the market by private companies. (WIPO, Standing Committee on the Law of Patents, SCP/14/4 Rev.2, 2011).

"Territory"

Alternative One: the countries set forth in [Schedule]. (Medicines Patent Pool and Gilead Amended and Restated License Agreement, §12).

Alternative Two: the countries listed in [Schedule] and such other or different countries as the Parties may agree in writing. (Medicines Patent Pool and Bristol-Myers Squibb Company License and Technology Transfer Agreement, §1.1).

"Tiered Pricing" (also: Differential Pricing)

Alternative One: When companies charge different prices for the same product depending on the class of purchaser. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).

Alternative Two: The concept of selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries. (Moon S, Jambert E, Childs M, von Schoen-Angerer  T. A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries, Globalization and Health 739 (2011). https://doi.org/10.1186/1744-8603-7-39).

"Trade-Related Aspects of Intellectual Property Rights" (also: TRIPs)

An agreement annexed to the World Trade Organization convention aimed at strengthening and harmonizing aspects of the protection of intellectual property at the global level. It includes trademarks and patents as well as other forms of intellectual property. (WHO Access to Medicines Glossary).

"Trademark"

A sign capable of distinguishing the goods or services of one enterprise from those of other enterprises. They are protected by intellectual property rights and are used to brand both original and generic products. (World Intellectual Property Organization, About IP, Trademarks).

"TRIPS Flexibilities"

There are different options through which TRIPS obligations can be transposed into national law so that national interests are accommodated and yet TRIPS provisions and principles are complied with. This definition would effectively delimit the scope of the concept through the following elements: (i) it highlights the idea of various options for means of implementation; (ii) it refers to the legislative process of implementation, reflecting that the first step to get advantage of a given flexibility consists in incorporating it into the national law; (iii) it refers to the reason for flexibilities, which is to accommodate national interest; and (iv) it reflects that a given flexibility needs to be compatible with the provisions and principles of the treaty. Neither the TRIPS Agreement nor any of the later instruments have formally defined the exact meaning of this term. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).

U

"U.S. Government Bayh-Dole Rights"

The U.S. Government march-in rights set forth in[codified in USC 35 §§ 200 et seq. and implemented by] 37 CFR Sect. 401.6 and 401.14 (j). (CARB-X Research Subaward Agreement, §6.04).

W

"WHO Prequalification"

A systematic process to determine the capacity of a manufacturer to produce a product of consistent quality in accordance with international standards and WHO/UNFPA specifications. The purpose of prequalification is to protect the buyer and the end user by ensuring good quality products are procured and distributed. (WHO: Reproductive Health Essential Medicines).

"Wilful Misconduct" (also: Willful Misconduct)

An act or omission taken (a) intentionally to achieve a wrongful purpose; (b) knowingly without legal or factual justification; and (c) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. Each of the foregoing conditions must be proven with clear and convincing evidence. (Advance Purchase Agreement for the Production, Purchase and Supply of a COVID-19 Vaccine in the European Union, §1.52 ).

© Global Healthcare Innovation Alliance Accelerator 2020. This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. Last updated in November 2020.