Master Alliance Provisions Guide (MAPGuide)

Glossary

This glossary includes definitions of some key terms found in MAPGuide provisions. The purpose of this glossary is to improve user understanding of MAPGuide provisions by providing definitions of terms that are not commonly used, or may have specific meanings in the context of global health agreements. Definitions tend to vary from agreement to agreement – where those variations can be substantial, we have provided one or more alternatives, although this should not be considered an exhaustive list. Most of the definitions included are taken from agreements found in the MAPGuide, some supplementary definitions have been provided for common abbreviations, and links to external sources have been added for further explanation of complex terms.

A

"Active Pharmaceutical Ingredient" (also: API, active pharmaceutical ingredients) The chemical substance responsible for a product’s effect.
"Adverse Event" (also: Adverse Events) Any untoward medical occurrence in a patient who is administered the Product, whether or not considered related to the Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease associated with the use of the Product.
"Affordable Pricing" (also: Affordable Price) There are several definitions of Affordable Pricing found in agreements in the MAPGuide, for example: Alternative 1 - 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). Alternative 2 - The maximum price at which a Final Product may be offered for sale in the Territory, reflective of the lowest, sustainable, competitive price level for a Final Product, to be agreed upon between [the parties].

B

"Background" (also: Background Intellectual Property, Background IP, Background Technology, Awardee Background IP, Background Invention) There are several definitions of Background found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - discoveries, inventions, know-how, patents and patent applications, trademarks and trademark applications, copyrights and copyrightable materials and other intellectual property rights that are owned or controlled by Awardee at the Effective Date or that Awardee develops, acquires or otherwise comes to own or control after the Effective Date outside the scope of the Project and without any [funder] funding. Alternative 3 - 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.
"BARDA" Biomedical Advanced Research and Development Authority. About BARDA.
"Best Efforts" The activities and degree of effort that a public institution, in case of Licensees, or company of similar size with a similarly-sized infrastructure and similar resources as Licensees would undertake or use at the relevant stage of Development or Supply, 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.
"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.
"BLA" A Biologics License Application, as defined in the FDCA and regulations promulgated thereunder, or similar application, or any successor application or procedure.

C

"CMC" Chemistry, Manufacturing and Control
"CMO" (also: CMOs) Contract manufacturing organization.
"Combination Product" (also: Combination Products) A product that includes one or more products or other components which are Licensed Products that is sold in combination with one or more separate products or other components which are not Licensed Products and that are sold by Company as stand-alone products.
"Commercial Benefits" Any economically quantifiable benefits that arise from the commercial exploitation of the Project Results other than in preparation for or in response to an Outbreak or Increased Outbreak Preparation Need. Examples of Commercial Benefits include the commercial licensing of Project IP, receipt of government-granted incentives such as Priority Review Vouchers and revenue from the commercialization of combination, derivative or follow-on products (including antibody products, assays and vaccines) or application of production technology.
"Commercialization" (also: Commercialize, Commercializing, Commercializes, Commercialized, Commercialization, Commercialise, Commercialisation, Commercialised, Commercialising, Commercialises, ) There are several definitions of Commercialization found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - 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.
"Commercially Reasonable Efforts" (also: Commercially Reasonable Effort, CRE) There are several definitions of Commercially Reasonable Efforts found in agreements in the MAPGuide, for example: Alternative 1 - The efforts and resources that a similarly situated company or institution, as applicable, would use for its own internally discovered [compounds/assets] of similar commercial potential and similar stage of development, taking into consideration the likely timing of the entry into the market, any patent and other proprietary position and issues of safety and efficacy. Alternative 2 - (a) in the case of [supplier], the activities and degree of effort that a group of a similar size with a similarly-sized infrastructure and similar resources as [supplier's] group would undertake or use in the development, manufacture, approval and supply of a therapeutic product (including having regard to one for treating patients to combat the current COVID-19 global pandemic) at the relevant stage of development or commercialization having regard to the urgent need for such products including taking into account efficacy and safety. Such efforts being subject to (i) those activities which are within the power or influence of [supplier] having regard to its arrangements with the licensor of the Product and such licensor's obligations and rights in relation to Roche seeking regulatory approval and (ii) the requirement for the [government] Approval; and (b) in the case of [purchaser], the activities and degree of effort that governments would undertake or use in supporting their contractor in the supply of drugs having regard to the urgent need for drugs to treat patients in a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world.

D

"Developing Countries" (also: Developing Country) There are several definitions of Developing Countries found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - 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 [...].
"Development" (also: Develop, Developed, development, develop, developed) 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.
"Diligent Efforts" With respect to a Party, those efforts, expertise and resources commensurate with efforts, expertise and resources commonly used in the biopharmaceutical industry by a company of comparable size in connection with the development, manufacture and/or commercialization of a comparable high priority pharmaceutical product which is of similar market potential at a similar stage of development or commercialization in light of issues of safety and efficacy, product profile, public health, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products, product reimbursement, and other relevant factors such as technical, legal, scientific, or medical factors. Diligent Efforts shall be determined on a market-by-market and indication-by-indication basis for each [Product], and it may change over time.

E

"Equitable Access" There are several definitions of Equitable Access found in agreements in the MAPGuide, for example: Alternative 1 - in the context of an Outbreak means that appropriate [vaccines] are first available to populations when and where they are needed to end an Outbreak or curtail an epidemic, regardless of ability to pay; Alternative 2 - a [Project Vaccine] is available first to populations at risk when and where they are needed at affordable prices.
"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. Grantee is required to retain sufficient rights in the Funded Developments and Essential Background Technology to grant this license. Grantee must ensure this license survives the assignment or transfer of Funded Developments or Essential Background Technology.
"EUA" (also: Emergency Use Authorization, Emergency Use Authorisation) There are several definitions of Emergency Use Authorization found in agreements in the MAPGuide, for example: Alternative 1 - Emergency Use Authorization, as defined in the FDCA and regulations promulgated thereunder, or similar request, application, authorization or procedure. Alternative 2 - A risk-based procedure developed by a Stringent Regulatory Authority to approve the use of a vaccine under development for use during a public health emergency.
"EUL" (also: Emergency Use Listing) A risk-based procedure developed by the WHO for assessing and listing candidate in vitro diagnostics, therapeutics and vaccines for use during public health emergencies.
"Exploitation" (also: Exploit, Exploiting, Exploited, exploit, exploitation, exploited, exploiting) To make, have made, use, offer to sell, sell, Develop, Manufacture, perform Medical Affairs, Commercialize, or otherwise exploit.

F

"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.
"Foreground Intellectual Property" There are several definitions of Foreground Intellectual Property found in agreements in the MAPGuide, for example: Alternative 1 - Intellectual Property arising out of the performance of the Services under this Agreement (but for the avoidance of doubt excluding Background Intellectual Property). Alternative 2 - Any Intellectual Property (including the Project Patents and Project Inventions) arising out of the undertaking and performance of [...] the Project.
"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).

G

"GMP" (also: Good Manufacturing Practices, cGMP, cGMPs) The then-current good manufacturing practices, standards, guidelines and regulations promulgated and published by the FDA, EMA and such other jurisdiction agreed upon by the Parties in writing, relating to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs including any standards, guidelines and regulations as promulgated by, as applicable: (a) the FDA under and in accordance with the U.S. Federal Food, Drug and Cosmetic Act and Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations, (b) the EMA and the EU Commission under European Directive 2003/94/EC, and/or (c) the ICH Harmonised Tripartite Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients (ICH Q7), as such standards, guidelines and regulations may be amended from time to time.
"GDP" Good distribution practices in accordance with standards currently required by EU legislation, regulation and guidance, in particular those set out in its Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use published by the European Commission (2013/C 343/01) and other applicable regulation pertaining to distribution practices throughout the supply chain, all as updated, amended and revised from time to time.
"Global Access" Requires that (a) the knowledge and information gained from the Project will be promptly and broadly disseminated; and (b) the Funded Developments will be made available and accessible at an affordable price (i) to people most in need within developing countries, or (ii) in support of the U.S. educational system and public libraries, as applicable to the Project.
"Global Access Objectives" (also: Global Access Objective) 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.
"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.
"Government Purpose Rights" Per the U.S. Defense Federal Acquisition Regulation Supplement ("DFARS"): the rights to - (i) Use, modify, reproduce, release, perform, display, or disclose technical data within the Government without restriction; and (ii) Release or disclose technical data outside the Government and authorize persons to whom release or disclosure has been made to use, modify, reproduce, release, perform, display, or disclose that data for United States government purposes. Read more about DFARS 252.227-7013.

H

"HICs" (also: HIC, High-Income Countries) High Income Countries (see the World Bank income classifications here).
"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.

I

"Improvements" (also: Improvement) There are several definitions of Foreground Intellectual Property found in agreements in the MAPGuide, for example: Alternative 1 - All improvements, methods [including manufacturing processes], modifications and other know-how [including any chemistry improvements or modifications,] developed by or on behalf of a Licensee and relating to API or a Product. Alternative 2 - any (patentable or unpatentable) new or improved formulation, process, improvement, invention, development or finding related to the Substance and/or the Product, or any (patentable or unpatentable) other pharmaceutical product using Substance, or any further invention (patentable or unpatentable) that relates to the manufacture or formulation of the Products and/or Substance or incorporate or are based on the Patents, developed by Sublicensee after the Effective Date. Alternative 3 - any new or improved process, any new or improved manufacturing techniques or any further invention or know-how which relate to the manufacture or formulation of the Licensed Products, or incorporate or are based on the Licensed Technology, developed by or on behalf of [a Licensee].
"IND" (also: INDs) Investigational New Drug Application. Read more.
"Intellectual Property" (also: Intellectual Property Rights, Intellectual Property Right, IP) There are several definitions of Intellectual Property found in agreements in the MAPGuide, for example: Alternative 1 - On a worldwide basis any and all (a) patents, applications for patents (including, without limitation, divisions, continuations, continuations-in-part and reexamination applications) and any renewals, extensions or reissues thereof; (b) trademarks, service marks, whether or not registered, copyrights and registrations or applications for registration of copyrights, rights associated with works of authorship, including copyrights, moral rights and mask-works; (c) designs, algorithms and other industrial property rights; (d) computer software, including, without limitation, source code, operating systems and specifications, documentation and other written materials related thereto; (e) trade secret rights; (f) data; (g) other ideas, inventions (whether or not patentable), methods, research information and knowhow; (h) reagents, kits, chips, microarrays, instrumentation, devices used for genetic tests, compositions, methods, markers and method to direct treatment; (i) other intellectual and industrial property rights of every kind and nature, however designated, whether arising by operation of law, contract, license or otherwise; and (j) registrations, applications, renewals, extensions, continuations, divisions or reissues thereof now or hereafter in force (including, without limitation, any rights in any of the foregoing). Alternative 2 - Patents, rights to inventions, trade marks, service marks, registered designs, copyrights and related rights, database rights, design rights, rights to use and protect confidential information, in each case whether registered or unregistered, including rights to apply for and be granted and applications for any of the above, and any continuations, continuations-in-part, divisional applications, renewals or extensions of, and rights to claim priority from, those rights, and any similar right recognised from time to time in any jurisdiction, together with all rights of action in relation to the infringement of any of the above.
"Investigational Product" (also: Investigational Products) A Product that has not received a marketing approval.
"IPDP" (also: iPDP) Integrated Product Development Plan

J

"JMAG" Joint Monitoring and Advisory Group
"JPEO-CBRND" Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense. About JPEO-CBRND.

K

"Know-how" (also: Know-How, Know How) There are several definitions of Know-How found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - Any and all proprietary information and materials, including discoveries, improvements, processes, methods, protocols, formulas, molecular constructs, cell lines, reagents, assays, data, seeds (including pre-seeds, master seeds and working seeds), cell banks (including master cell banks and working cell banks), clones, primers, vectors, antibodies, serum samples, biological samples, results, inventions, know-how, trade secrets, compositions of matter (including compounds), formulations, and findings, in each case, patentable or otherwise. Alternative 3 - Any technical intangible technique, information, technology, practice, trade secret, invention (whether patentable or not), method, process, knowledge, know-how, conclusion, skill, experience, test data and results (including pharmacological, toxicological, manufacturing and clinical test data and results), regulatory documentation, analytical and quality control data, software or algorithm, database, standard operating procedure, study report, technical document, batch record or other research, development and manufacturing information. Know-How also includes the tangible (i.e., written or electronic) files that record any of the foregoing; provided, however, that Know-How does not include (i) Patents, (ii) Materials or (iii) trademarks and domain names (or any applications or registrations thereof). Alternative 4 - All non-public technical, scientific, and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, designs, drawings, assembly procedures, software, computer programs, apparatuses, specifications, data, results and materials, including: biological, chemical, vaccine-related, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays, and biological methodology, in all cases, whether or not copyrightable or patentable, in written, electronic or any other form now known or hereafter developed.

L

"Least Developed Countries" Africa (34): Angola, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Comoros, Democratic Republic of the Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gambia, Guinea, Guinea-Bissau, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Rwanda, São Tomé and Príncipe, Senegal, Sierra Leone, Somalia, South Sudan, Sudan, Togo, Uganda, United Republic of Tanzania, Zambia Asia (14): Afghanistan, Bangladesh, Bhutan, Cambodia, Kiribati, Lao People’s Democratic Republic, Myanmar, Nepal, Samoa, Solomon Islands, Timor-Leste, Tuvalu, Vanuatu, Yemen Latin America and the Caribbean (1): Haiti (Source: United Nations Office of the High Representative (UN-OHRLLS) as of October 23, 2013)
"LICs" (also: LIC, Low-Income Countries) Low Income Countries (see the World Bank income classifications here).
"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.
"Limited Rights" (also: Limited rights) Per the U.S. Defense Federal Acquisition Regulation Supplement ("DFARS"): the rights to use, modify, reproduce, release, perform, display, or disclose technical data, in whole or in part, within the Government. The Government may not, without the written permission of the party asserting limited rights, release or disclose the technical data outside the Government, use the technical data for manufacture, or authorize the technical data to be used by another party, except that the Government may reproduce, release, or disclose such data or authorize the use or reproduction of the data by persons outside the Government if - (i) The reproduction, release, disclosure, or use is - (A) Necessary for emergency repair and overhaul; or (B) A release or disclosure to - (1) A covered Government support contractor in performance of its covered Government support contract for use, modification, reproduction, performance, display, or release or disclosure to a person authorized to receive limited rights technical data; or (2) A foreign government, of technical data other than detailed manufacturing or process data, when use of such data by the foreign government is in the interest of the Government and is required for evaluational or informational purposes; (ii) The recipient of the technical data is subject to a prohibition on the further reproduction, release, disclosure, or use of the technical data; and (iii) The contractor or subcontractor asserting the restriction is notified of such reproduction, release, disclosure, or use. Read more about DFARS 252.227-7013.
"LMICs" (also: Low- and Middle-Income Countries, LMIC) Alternative 1 -Those countries defined by the Organisation for Economic Co-operation and Development. Alternative 2 -This term is sometimes used to refer to Low- and Middle-Income Countries, and sometimes to refer to Lower-Middle Income Countries (see the World Bank income classifications here).

M

"Manufacture" (also: Manufactured, Manufacturing) There are several definitions of Manufacture found in agreements in the MAPGuide, for example: Alternative 1 - With respect to a compound or product, including a Compound, Product and any other active pharmaceutical ingredient in a Product, the receipt, handling and storage of active pharmaceutical ingredients and other materials, the manufacturing, processing, packaging and labeling (excluding the development of packaging and labeling components for Marketing Authorization), holding (including storage), quality assurance and quality control testing (including release and stability) of such compound or product (other than quality assurance and quality control related to development of the manufacturing process, which activities shall be considered Development activities) and shipping of such compound or product. Alternative 2 - All activities involved in or relating to the manufacturing, quality control testing (including in-process, release and stability testing), processing, Labelling, releasing, packaging, storage and transport of the Product immediately prior to supply to the Purchaser hereunder. Alternative 3 - The production, subject to GMP, of Product or constituents thereof, including active ingredients, excipients, adjuvants, preservatives or other additives, for use in Clinical Trials or finished dosage form of the Product as well as the fill and finish or packaging thereof.
"Market" (also: Marketing) In relation to a Product, importing, exporting, marketing, selling, promoting, distributing or otherwise utilising or commercially exploiting the Product or licensing the right to do so or offering to do the any of the foregoing as well as any variations, licenses, or post-marketing obligations pursuant thereto.
"Marketing Authorization" (also: Marketing Authorizations, Marketing Authorisation, Marketing Authorisations, Marketing Approval) There are several definitions of Marketing Authorization found in agreements in the MAPGuide, for example: Alternative 1 - All approvals (including BLA approval, as applicable) from the relevant Regulatory Authority necessary to market and sell a Product in any country (including all applicable Price Approvals even if not legally required to sell Product in a country). Alternative 2 - a marketing authorisation granted by the European Commission in accordance with the procedure for the authorisation and supervision of medicinal products for human use set forth in Regulation (EC) No. 726/2004, or any Approved Regulatory Authority and any corresponding Regulatory Approval necessary to manufacture, use , sell or store a Product in any other country or jurisdiction, but not including pricing and reimbursement approvals.

O

"Open Access" The practice of providing online access to scientific information that is free of charge to the end-user and reusable.
"Outbreak" A Public Health Emergency of International Concern declared by WHO or a public health emergency on a national or regional scale declared by one or more national governments and in each case for a material increase in the number of cases of people infected in the Field including any regional outbreak, an epidemic or a pandemic.

P

"Pandemic" An outbreak of a disease that occurs over a wide geographic area and affects a large proportion of people in such area.
"Pandemic Period" Pandemic Period means the worldwide situation / period which the World Health Organization declares as Public Health Emergency of International Concern in relation to the SARS-CoV-2 virus.
"Pandemic Product" A Product (i) which is indicated for the prevention of COVID19 for which a Pandemic has been declared by a Governmental Authority and (ii) for which the purchaser of such Product is a Governmental Authority that is purchasing the Product for the Pandemic, including but not limited to for stockpiling, emergency use, humanitarian donations and other circumstances, other than for sales in the ordinary course of business. A Product shall be deemed a Pandemic Product for so long as these two criteria are met.
"Patent Rights" (also: Patent Right, Patents, Patent) There are several definitions of Patent Rights found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - Worldwide rights to the inventions described and claimed in the patents and patent applications identified as Patent Rights in the Transaction Terms; reissues, reexaminations, renewals, extensions, divisionals, continuations (including continuations-in-part (CIPs) only to the extent that the claims in such CIPs are entitled to the priority date of, and fully supported by, another patent or application in the Patent Rights) of the foregoing; and any extensions of or supplementary protection certificates referencing any of the foregoing, foreign counterparts and any other forms of protection directed to the inventions covered by the patents and patent applications identified as Patent Rights in the Transaction Terms. Alternative 3 - Issued patents and pending patent applications (including certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications (and any U.S., international, multinational or foreign patents or patent applications thereof), re-filings, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations, and all international or foreign counterparts of any of the foregoing (including Patent Extensions, patents of addition and the like). Alternative 4 - (a) the patents and patent applications set forth in Appendix [x] hereto and (b) any other patents or patent applications (and resulting patents therefrom) that are (i) owned and controlled by [Licensor] and its Affiliates during the term of this Agreement and (ii) necessary for Licensee to practice the licenses granted [in Section x hereof], including patents and patent applications claiming improvements or modifications to the manufacture of API, in each of (a) and (b) solely to the extent the claims in such patents and patent applications cover the manufacture, use or sale of API.
"PHEIC" Public Health Emergency of International Concern (WHO's highest health emergency alert level).
"Practical Application" With respect to a Subject Invention, to manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions so as to establish that the Subject Invention is capable of being utilized.
"Project Data" All data and information, including all clinical study data, produced or arising as a result of the Project.
"Project Intellectual Property" (also: Project IP) Any discoveries, inventions, know-how, patents, trademarks and other forms of intellectual property that arise under the Project.
"Project Results" There are several definitions of Project Results found in agreements in the MAPGuide, for example: Alternative 1- 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. Alternative 2- All of the tangible results that are made or developed by Awardee under the Project, including the Project Vaccine, and directly related to such Product Vaccine, assays necessary for Project Vaccine production, whether in whole or in components, protocols used in Project Vaccine clinical or non-clinical evaluation, Project Data, and Project Materials
"Public Health License" There are several definitions of Public Health License found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - A grant by Awardee to [funder] of all relevant rights under Project Results, Enabling Rights and Background IP for use in the Field by [funder].
"Public Sector" (also: Public Purchasers, Public Sector Purchaser, Public Sector Purchasers, Public Sector Agency, Public Sector Agencies) There are several definitions of Public Sector or Public Purchasers found in agreements in the MAPGuide, for example: Alternative 1 - (i) a government or a department or agency thereof, including ministries of health; (ii) intergovernmental organizations, including the United Nations, its Specialized Agencies such as the World Health Organization and its Programmes or Funds such as the United Nations Children’s Fund(UNICEF); (iii) a non-profit organization or entity organized under the laws of a government or department or agency thereof, including non-governmental organizations such as Médecins sans Frontiéres and faith-based organizations; and (iv) entities (including entities in the private sector) that are funded by governments or non-profit organizations or foundations such as the UNICEF, the President’s Emergency Plan for AIDS Relief, or the Global Fund to Fight AIDS, Tuberculosis and Malaria. Alternative 2 - governmental health ministries and other governmental agencies of Developing Countries, the Global Fund for Children’s Vaccines, the WHO, World Bank, UNICEF and other governmental and non-profit charitable agencies or organizations, including PATH, and shall include without limitation United States and European governmental agencies (e.g. USAID, DANIDA, DFID and GTZ) that may purchase vaccines for delivery, distribution and/or sale to Developing Countries. Alternative 3 - (a) the following organizations to the extent that they are not for profit organizations: (i) Governments including without limitation government ministries and agencies, together with government-funded institutions and programs, such as state-run hospitals and prison services in those countries; (ii) NGOs including without limitation those recognized by the applicable local government ministry; (iii) UN-related organizations working for or in those countries, including but not limited to UNDP and UNICEF; (iv) Not-for-profit organizations including without limitation, Médecins Sans Frontières, Save-the-Children, OXFAM and the International Committee of the Red Cross (ICRC); (v) Funding mechanisms and programs funded by such mechanisms, including without limitation, Unitaid, PEPFAR, USAID, Global Fund, etc.; and (vi) agencies based outside of an applicable country to the extent that they are supplying Licensed Products in the Territory, and (b) nominally for profit procurement organisations but only to the extent that such procurements are supporting not-for-profit treatment programmes as described in (a) above.

R

"Reasonable Effort" (also: Reasonable Efforts) (i) with respect to the Partner, in good faith making no less commercially reasonable effort and committing no less resources than those commonly used by the Partner or, if greater, a company of similar size and with similar resources to the Partner and its Affiliates in the vaccine industry when applied to platforms, compounds, vaccines and products at a similar stage of development, life cycle and healthcare potential to the Platform and Product being developed, taking into account (a) all relevant factors including issues of safety and efficacy, product profile, difficulty in Developing or Manufacturing, sourcing raw materials necessary therefor, regulatory approvals, the patent or other proprietary position of the Platform or Project Vaccine and the regulatory requirements involved; and (b) the Parties’ joint aim of developing the Platform and Project Vaccine in a diligent and timely manner as indicated by the Milestones and Milestone Dates; (ii) with respect to the [funder], the use of reasonable efforts and resources, in good faith, in the exercise of prudent legal, medical, scientific judgement (as applicable) considering [funder's] mission and the healthcare potential of the applicable Platform and Product.
"Regulatory Approval" (also: Regulatory Approvals) There are several definitions of Regulatory Approval found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - The approval by any Regulatory Authority to market and sell the Products in the respective markets, including any pricing approval. For clarity, Regulatory Approvals include Emergency Use Authorizations and other accelerated, conditional or temporary authorizations or approvals.
"Regulatory Authority" (also: Regulatory Authorities, regulatory authority, regulatory authorities) There are several definitions of Regulatory Authority found in agreements in the MAPGuide, for example: Alternative 1 - 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. Alternative 2 - The Service and Product relevant international, federal, provincial, state or local governmental or regulatory bodies, agencies, departments, bureaus, courts or other entities responsible for (a) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use, including the FDA, EMA, United States Drug Enforcement Agency or any other international, federal, state or local regulatory bodies, agencies, departments, bureaus, courts or other entities responsible for the regulation of drugs, (b) granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the manufacturing or use of products, or (c) health, safety or environmental matters generally.
"Regulatory Documentation" (also: Regulatory Filing, Regulatory Filings) There are several definitions of Regulatory Documentation, or Regulatory Filing, found in agreements in the MAPGuide, for example: Alternative 1 - All applications, registrations, licenses, authorizations and approvals (including all Marketing Authorizations), all correspondence submitted to or received from Regulatory Authorities (including [*]) and all supporting documents in connection therewith, and all reports and documentation in connection with clinical studies and tests (including [*]), and [*] in any of the foregoing, including all INDs, BLAs, [*], in each case related to a Compound and/or Product. Alternative 2 - All applications, filings, submissions, approvals, licenses, registrations, Permits, notifications, authorizations (or waivers) and approvals (including all Regulatory Approvals) and all correspondence submitted toor received from any Regulatory Authority (including minutes and official contact reports relating to any communications with anyRegulatory Authority) and all supporting documents with respect to Clinical Trials or studies, or the Development, Manufacture or Commercialization of the Product and all Data contained in any of the foregoing made to or received from any Regulatory Authority in a given country, including BLAs, MAAs and INDs, regulatory drug lists, advertising and promotion documents, Manufacturing data, drug master files, Clinical Data, Adverse Event files and complaint files.
"Restricted Rights" (also: Restricted rights) apply only to noncommercial computer software and mean the Government's rights to - (i) Use a computer program with one computer at one time. The program may not be accessed by more than one terminal or central processing unit or time shared unless otherwise permitted by this contract; (ii) Transfer a computer program to another Government agency without the further permission of the Contractor if the transferor destroys all copies of the program and related computer software documentation in its possession and notifies the licensor of the transfer. Transferred programs remain subject to the provisions of this clause; (iii) Make the minimum number of copies of the computer software required for safekeeping (archive), backup, or modification purposes; (iv) Modify computer software provided that the Government may - (A) Use the modified software only as provided in paragraphs (a)(15)(i) and (iii) of this clause; and (B) Not release or disclose the modified software except as provided in paragraphs (a)(15)(ii), (v), (vi) and (vii) of this clause; (v) Permit contractors or subcontractors performing service contracts (see 37.101 of the Federal Acquisition Regulation) in support of this or a related contract to use computer software to diagnose and correct deficiencies in a computer program, to modify computer software to enable a computer program to be combined with, adapted to, or merged with other computer programs or when necessary to respond to urgent tactical situations, provided that - (A) The Government notifies the party which has granted restricted rights that a release or disclosure to particular contractors or subcontractors was made; (B) Such contractors or subcontractors are subject to the use and non-disclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement (DFARS) or are Government contractors receiving access to the software for performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends; (C) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and (D) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iii) of this clause; (vi) Permit contractors or subcontractors performing emergency repairs or overhaul of items or components of items procured under this or a related contract to use the computer software when necessary to perform the repairs or overhaul, or to modify the computer software to reflect the repairs or overhaul made, provided that - (A) The intended recipient is subject to the use and non-disclosure agreement at DFARS 227.7103-7 or is a Government contractor receiving access to the software for performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends; (B) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and (C) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iii) of this clause; and (vii) Permit covered Government support contractors in the performance of covered Government support contracts that contain the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends, to use, modify, reproduce, perform, display, or release or disclose the computer software to a person authorized to receive restricted rights computer software, provided that - (A) The Government shall not permit the covered Government support contractor to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and (B) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iv) of this clause. Read more about DFARS 252.227-7014.
"Results" (also: Result, 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.

S

"Serious Adverse Event" (also: Serious Adverse Events, SAE) Any Adverse Event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect, as defined more fully in 21 C.F.R. § 312.32.
"Sideground" (also: 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.
"Step-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. Also referred to as “March-in Rights.”
"Stringent Regulatory Authority" (also: SRA) A regulatory authority which is: (a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or (b) an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or (c) a regulatory authority associated with an ICH member through a legally binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).
"Subject Invention" (also: Subject Inventions) Any invention of the [Project Agreement Holder] or its subcontractors of any tier conceived or first actually reduced to practice in the performance of work on a Project Agreement under this Agreement.
"Sublicense" (also: sublicense, sublicenses, Sublicenses, sublicensable, sublicenseable, sublicensing, sub-license, sub-licenses, sub-licensable) The grant of certain licensed rights to a third party by a licensee.

T

"Technology" (also: technology) There are several definitions of Technology found in agreements in the MAPGuide, for example: Alternative 1 - All patents, patent applications, inventions, trade secrets, copyrights, know-how, methods, processes, techniques, improvements, data, technical documentation, manuals, regulatory submissions, specifications, SOPs, instructions, and other intellectual property of any kind (whether or not protected or protectable under patent, trademark, copyright or similar laws). Alternative 2 - Collectively, data, results, technology, inventions, discoveries, improvements, trade secrets and proprietary methods, whether or not patentable and in any tangible or intangible form, including: (a) methods of manufacture or use of, and structural and functional information pertaining to, biologics;(b) compositions of matter, data, formulations, processes, techniques, know-how and results; and (c) unregistered design rights, copyright, database rights, rights in respect of confidential information, rights under data exclusivity laws, rights under orphan drug laws, rights under unfair competition laws, property rights in biological or chemical materials, extension of the terms of any such rights, applications for and the right to apply any of the foregoing registered property and rights, and similar or analogous rights. For clarity, Technology excludes Patent Rights.
"Technology Transfer" 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.
"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.
"Trusted Collaborator" (also: Trusted Collaborators, Trusted Partner, ) A third party, that is capable of performing the work and would be prepared to undertake activities in the event that Awardee declines [Funder's] request to do so, or if Awardee and Funder do not reach agreement on a new Work Package.

U

"UMICs" (also: UMIC, Upper-Middle Income Countries) Upper Middle Income Countries (see the World Bank income classifications here).
"Unlimited Rights" Per the U.S. Defense Federal Acquisition Regulation Supplement ("DFARS"): rights to use, modify, reproduce, perform, display, release, or disclose technical data in whole or in part, in any manner, and for any purpose whatsoever, and to have or authorize others to do so. Read more about DFARS 252.227-7013.
"U.S. Government Bayh-Dole Rights" (also: Bayh-Dole statute, Bayh-Dole Act) This generally refers to Title 37 of the Code of Federal Regulations (CFR), part 401. Read More.

W

"WHO Prequalification" (also: WHO PQ) The positive written advice provided by the WHO to United Nations agencies of the acceptability of CovidVaccine for purchase by United Nations agencies and the inclusion of Covid Vaccine on the list of pre-qualified vaccines for such purchase.