Master Alliance Provisions Guide (MAPGuide)

Glossary

This glossary includes definitions of the key terms in the MAPGuide and from other public health-related agreements or publications, and serves as a reference for the common definitions used in global health alliance agreements. It is not intended to be used separately from the MAPGuide.

A

"Access Right" There are two definitions of “Access Right” used in the MAPGuide: (1) The right to use results under the terms and conditions laid down in this Agreement. (2) The right(s) to use.
"Active Pharmaceutical Ingredient" (also: API, active pharmaceutical ingredients) The chemical substance responsible for a product’s effect.
"Affected Territory" (also: Affected Territories) There are two definitions of Affected Territory in the MAPGuide: (1) 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. (2) The geographic area of any country where there is an Outbreak or that is at risk of an Outbreak taking into account epidemiological data, travel and migration patterns and the lack of availability of other products or product candidates.
"Affiliate" (also: Affiliates) Any Person which, directly or indirectly, is controlled by, controls or is under common control, with another such Person. For the purposes of this definition, the term control as used with respect to a Person shall mean the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.
"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).

B

"Background" There are three definitions of “Background” used in the MAPGuide: (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. (2) 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. (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. Also see the definitions of “Background Intellectual Property (IP)” and “Background Technology.”
"Background Intellectual Property" (also: Background IP, background intellectual property) 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. Also see the definitions of “Background” and “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. Also see the definitions of “Background” and “Background Intellectual Property (IP).”
"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.

C

"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.
"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.)
"Commercialization" (also: Commercialize) There are two definitions of “Commercialization” used in the MAPGuide: (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. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning. (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. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning Also see the definition of “Commercialization Plan.”
"Commercialization Plan" A plan, no later than [six (6) months] after the first approval of the Product, describing the Targeted Territories to commercialize the Product. Also see the definition of “Commercialization.”
"Commercially Reasonable Efforts" (also: Commercially Reasonable Effort, CRE) There are two definitions of Commercially Reasonable Efforts in the MAPGuide: (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. (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.
"Comparative Data" All Data resulting from comparative evaluation of Non-Standardized Data or Standardized Data produced by a _____ Member. Also see the definitions of “Standardized Data” and “Non-Standardized Data.”
"Comparative Standardized Data" All Data resulting from comparative evaluation of Standardized Data produced by a _______ Member; accordingly, Comparative Standardized Data is a subset of the Comparative Data
"Compulsory License" (also: Compulsory Licenses) 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.
"Confidential Information" There are four definitions of “Confidential Information” used in the MAPGuide: (1) Information, data or material in writing, that the Disclosing Party has prominently marked or otherwise prominently identified as confidential or proprietary in nature. (2) 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. (3) 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. (4) 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.

D

"Data" There are two definitions of “Data” used in the MAPGuide: (1) Factual information (as measurements or statistics) used as a basis for reasoning, discussion, or calculation, information in numerical form that can be digitally transmitted or processed. (2) Recorded information used or generated in the performance of a [Project].
"Developing Countries" (also: Developing Country) 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
"Development" (also: Develop) 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.
"Direct Exploitation" Developing results for commercialization, including through clinical trials, or commercializing results themselves.
"Disclosing Party" (also: Disclosing Parties) The party disclosing Confidential Information to the other Party in connection with the Project.

E

"Equitable Access" There are two definitions of “Equitable Access” used in the MAPGuide: (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; (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. Also see the definition of “Humanitarian License” where this definition has been referenced.

F

"Field" There are four definitions of “Field” used in the MAPGuide: (1) Pediatric treatment or prevention of disease or other therapeutic area. (2) 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. (3) The treatment or prevention of HIV which does not include the treatment or prevention of other viruses, including without limitation HCV. (4) The treatment of any and all therapeutic indications and uses.
"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 (defined below). Also see the definitions of “Foreground Intellectual Property,” “Project IP,” “Project Results,” and “Results.”
"Foreground Intellectual Property" There are two definitions of “Foreground Intellectual Property” used in the MAPGuide: (1) Intellectual Property arising out of the performance of the Services under this Agreement (but for the avoidance of doubt excluding Background Intellectual Property). (2) Any Intellectual Property (including the Project Patents and Project Inventions) arising out of the undertaking and performance of any Work Phase of the Project. Also see the definitions of “Foreground,” “Project IP,” “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).

G

"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" The rights to (i) use, modify, reproduce, release, perform, display, or disclose Data within the Government without restriction; and (ii) release or disclose 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 Government purposes. Government purposes include competitive procurement, but do not include the rights to use, modify, reproduce, release, perform, display, or disclose Data for commercial purposes or authorize others to do so.

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. Also see the definitions of “Essential Background Technology”, "Funded Developments" and “Public Health License.”

I

"Improvements" (also: Improvement) 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.
"Increased Outbreak Preparation Need" There are two definitions of “Increased Outbreak Preparation Need” used in the MAPGuide: (1) When, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, there is a determination that there is a heightened need for a Product. (2) When, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates in the Field, Funder determines, in its sole discretion, that there is a heightened need for the Product. Also see the definitions of “Outbreak,” “Outbreak Notice,” “Outbreak Preparation Activities,” and “Outbreak Response Activities.”
"Intellectual Property" 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).
"Intellectual Property Rights" There are two definitions of Intellectual Property Rights used in the MAPGuide (1) All patent rights, supplemental protection certificates and patent term extensions, trademarks, copyrights, design rights, database rights, domain names, rights in inventions, confidential information, know-how, trade names, business names, get-up, logos and trade dress, and all other rights in the nature of intellectual property rights (whether registered or unregistered) and all applications and rights to apply for the above, anywhere in the world in each case for their full term and any extension thereto. (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.

J

"Joint Program Know-How" Any Program Know-How (and Program Patent Rights that claim or cover such Program Know-How) that is conceived, discovered or reduced to practice by one or more employees, agents or consultants of [Party A], its Affiliates, or its subcontractors, together with one or more employees, agents or consultants of [Party B], its Affiliates, or its subcontractors. Also see the definitions of “Joint Program Patent Rights” and “Joint Project IP.”
"Joint Program Patent Rights" Any Program Patent Rights that claim or cover such Joint Program Know-How that is conceived, discovered or reduced to practice by one or more employees, agents or consultants of [Party A], its Affiliates, or its subcontractors, together with one or more employees, agents or consultants of [Party B], its Affiliates, or its subcontractors. Also see the definitions of “Joint Program Know-How” and “Joint Project IP.”
"Joint Project Intellectual Property" (also: Joint Project IP) Any Project IP which is conceived or reduced to practice, authored or contributed to, during activities carried out jointly by or on behalf of two (2) or more Parties under the Agreement. Also see the definitions of “Joint Program Know-How” and “Joint Program Patent Rights.”
"JPEO-CBRND" Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense

K

"Know-how" (also: Know-How) There are three definitions of Know-how used in the MAPGuide: (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. (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. (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).

L

"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.
"Licensed Patent Rights" (a) the patents and patent applications of ____ in the Territory related to the Licensed Compound; (b) any continuation, continuation-in-part (but only to the extent that such application includes new data in support of claims previously submitted in a prior originally filed application), divisional, and continued-prosecution applications of any patent applications included in paragraph (a); (c) any patents issuing from any patent applications included in the paragraphs (a) and (b), in each case, including any renewals, extensions, patents of addition, supplementary protection certificates, revivals, re-examinations, and reissues thereof.
"Licensed Products" (also: Licensed Product) There are two definitions of "Licensed Products" used in the MAPGuide: (1) Any human pharmaceutical products produced under license from ____ and/or ____ 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. (2) 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.
"Licensee" One to whom or to which a license is granted.
"Licensor" One who grants a license.
"Limited Rights" The rights to use, modify, reproduce, perform, display, or disclose Data or other information, in whole or in part, within the Government solely for research purposes for the Field. The Government will ensure that disclosed information is safeguarded in accordance with the restrictions of this Project Agreement. The Government may not, without the prior written permission of Recipient, release or disclose Data or other information outside the Government, use Data or other information for competitive procurement or manufacture, release or disclose Data or other information for commercial purposes, or authorize Data or other information to be used by another party.

M

"Manufacture" (also: Manufactured, Manufacturing) There are three definitions of Manufacture used in the MAPGuide: (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. (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. (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.
"Manufacturing Consultation" The process of making employees and consultants available to a party [as part of the technology transfer process] to provide consultation and technical assistance in order to ensure an orderly transition of the manufacturing technology and operations in the start-up of its manufacture of Compound and Product. Also see the definition of “Technology Transfer.”
"Marketing Authorization" (also: Marketing Authorizations) 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).
"Materials" There are three definitions of Materials used in the MAPGuide: (1) All types of tangible chemical, biological and/or physical materials. (2) Includes, but is not limited to, reagents, immunogens, vaccine products, adjuvants, viral isolates, DNA, RNA, vectors, plasmids, peptides, antibodies, hybridomas, monoclonal antibodies, peripheral blood mononuclear cells, sera, Progeny, and Unmodified Derivatives, or other preclinical and clinical samples. (3) Tangible compositions of matters, whether chemical or biological, such as, by way of example, cell lines, reagents, lipids, LNPs, delivery vehicles, antibodies, strains, proteins, nucleic acids and other materials used in the research, development and manufacture of pharmaceutical products. Materials exclude those tangible compositions of matters, whether chemical or biological, which a Party may independently obtain from a Third Party for commercial use.

N

"Net Sales" There are three definitions of “Net Sales” used in the MAPGuide: (1) 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. (2) 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: (a) trade discounts, including trade, cash and quantity discounts or rebates, credits or refunds; (b) allowances or credits granted upon claims, returns or rejections of products, including recalls, regardless of the party requesting such recall; (c) 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; (d) 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); (e) 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 (f) 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). (3) The invoiced price of a Licensed product sold at arm's length, the price that would have been invoiced if the sale had been at arm's length, after deducting, to the extent not already deducted from the gross amount invoiced or otherwise charged, reasonable and bona fide: (a) normal trade discounts, returns, expiries, rejects, destroyed stock and credits actually given; and (b) the costs of carriage, insurance, freight and packaging if invoiced separately to the customer; and (c) VAT, import duties and sales taxes actually paid by Commercialization Partners; and (d) free samples for promotional purposes with quantities in accordance with usual practices.
"Non-Standardized Data" All data not resulting from Standardized Assays other than Comparative Data. Also see the definitions of “Comparative Data” and “Standardized Data.”

O

"Open Access" The practice of providing online access to scientific information that is free of charge to the end-user and reusable.
"Other Territories" Countries that are not Targeted Territories. Also see the definition of “Targeted Territory.”
"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. Also see the definition of “Pandemic,” “Increased Outbreak Preparation Need,” “Outbreak Notice,” “Outbreak Preparation Activities,” and “Outbreak Response Activities.”
"Outbreak Notice" A notice, in writing in the event of an Outbreak. Also see the definition of “Increased Outbreak Preparation Need,” ”Outbreak,” “Outbreak Preparation Activities,” and “Outbreak Response Activities.”
"Outbreak Preparation Activities" Activities that include: (i) develop the Product in accordance with the Development Plan and as more particularly detailed in the Work Phase Statements; (ii) provide free of charge or at a discounted rate the services and facilities outlined in Schedule 3 in accordance with the timeframe (if any) set out at Schedule 3, the Application, and in more detail in specific Work Phase Statements; and (iii) use its Reasonable Efforts either to establish directly or to enter into an agreement with Funder, a Public Sector Agency or another third party, for supply of Product into an Investigational Stockpile before the first subject receives the first dose in a Phase II Clinical Trial and perform the related obligations. Also see the definition of “Increased Outbreak Preparation Need,” ”Outbreak,” and “Outbreak Response Activities.”
"Outbreak Response Activities" Activities that include: (i) the collection and sharing of trial subject information in accordance with Funder Policies, including information about pathogens such as sequence data; (ii) engagement with affected communities to establish mutual trust; (iii) integration of Partner research efforts into Public Sector Agencies’ epidemic response; (iv) manufacture of additional investigational doses of Product (if necessary) or manufacture to replenish Investigational Stockpile; (v) negotiation of clinical trial contracts; (vi) performance of independent ethics reviews; and (vii) implementation of prepared clinical trial designs. Also see the definition of “Increased Outbreak Preparation Need,” ”Outbreak,” and “Outbreak Preparation Activities.”

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: Patents) There are four definitions of "Patent Rights/Patents” used in the MAPGuide: (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. (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. (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). (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.
"Person" Any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.
"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.
"Program Know-How" Any Know-How (including any Compounds) that is first conceived, discovered, made and/or reduced to practice (as would be necessary to establish inventorship under United States patent law (regardless of where the applicable activities occurred)) by or on behalf of either Party or its Affiliate (or their respective employees, agents or consultants) or jointly by both Parties or their respective Affiliates (or their respective employees, agents or consultants) in performing the Transition Program or other activities under this Agreement.
"Project Data" All data and information, including all clinical study data, produced or arising as a result of the Project.
"Project Invention" Any discovery, development, Know-How, invention or improvement created, devised or arising out of the undertaking and performance of any Work Phase.
"Project Intellectual Property" (also: Project IP) Any discoveries, inventions, know-how, patents, trademarks and other forms of intellectual property that arise under the Project. Also see the definitions of “Foreground,” “Foreground Intellectual Property,” “Project Results,” and “Results.”
"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.
"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].
"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.
"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. Also see the definitions of “Foreground,” “Foreground Intellectual Property,” “Project IP,” and “Results."
"Public Health License" There are two definitions of 'Public Health License' used in the MAPGuide: (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. (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]. Also see the definitions of “Humanitarian License.” “Outbreak,” and “Increased Outbreak Preparation Need"

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 Platformand 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.
"Receiving Party" The party receiving Confidential Information from the other Party in connection with the Project. Also see the definition of “Disclosing Party.”
"Registration" The process of obtaining the necessary regulatory approval to distribute the Product. Also see the definitions of “Marketing Authorization” and “Regulatory Approval."
"Regulatory Approval" (also: Regulatory Approvals) 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.
"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. Also see the definitions of “Regulatory Approval” and “Regulatory Documentation.”
"Regulatory Documentation" 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. Also see the definitions of “Regulatory Approval” and “Regulatory Authority.”
"Research Data" Any information, in particular facts or numbers, collected to be examined and considered as a basis for reasoning, discussion, or calculation.
"Research Use" The use of results or background needed to use results, for all purposes other than for completing the action or for direct exploitation, and which includes but is not limited to the application of results as a tool for research, including clinical research and trials, and which directly or indirectly contributes to the objectives set out in the Societal Challenge health, demographic change and well-being.
"Results" (also: Result) 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. 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.
"Similar Product" Any pharmaceutical composition which infringes the Foreground Intellectual Property.
"Standardized Data" All data resulting from an assay after it has been defined as a Standardized Assay, which is performed by persons or organizations certified to perform. Also see the definitions of “Comparative Data” and “Non-Standardized Data.”
"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.”
"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.
"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) The grant of certain licensed rights to a third party by a licensee.

T

"Targeted Territories" (also: Targeted Territory) The key countries where the Product is intended to be marketed. Also see the definition of “Other Territories.”
"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.
"Territory" There are two definitions of “Territory” used in the MAPGuide: (1) The countries listed in [Schedule] and such other or different countries as the Parties may agree in writing. (2) The countries set forth in [Schedule]. Also see the definitions of “Developing Nations,” “Least Developed Countries,” and “Low and Middle Income Countries (LMIC).”
"Third Party" (also: Third Parties) Any person or entity who or which are neither a Party nor an Affiliate of a Party.
"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.
"Trial Steering Committee" (also: TSC) A group of independent experts who are not involved in the clinical study that will approve the clinical study protocol and monitor the progress of the clinical trial, including any changes to the protocol.
"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

"U.S. Government Bayh-Dole Rights" (also: Bayh-Dole statute, Bayh-Dole Act) 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).

W

"WHO" The World Health Organization.
"Wilful Misconduct" (also: Willful Misconduct, wilful 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.