The meaning of a number of specific terms will usually need to be laid out in detail to ensure common understandings amongst the parties. The language used should be accessible to researchers and those parties that will implement elements of the MTA. This is important because these parties are bound by terms that they may not be involved in negotiating or drafting but understanding their implications is nonetheless important.
Whether these terms will need to be included in the MTA and defined is completely dependent on the terms of the agreement, but might include:
Example text
“Access right” means rights to use results or background under the terms and conditions laid down in this Agreement. Unless agreed otherwise, access rights do not include the right to sub-license. However, any legal entity that enjoys access rights in order to complete the action or for research use may authorize another legal entity to exercise those rights on its behalf, provided that the following conditions are fulfilled: (a) the legal entity that enjoys access rights is liable for the acts of the other legal entity as if those acts had been performed by this former legal entity; (b) access rights granted to the other legal entity do not include the right to sub-license.
Stripped of identifying information and of codes that could be used to link data or samples back to a specific individual. Although anonymous materials do not by definition contain linking codes, they need not necessarily be de-identified (as defined below). Note that materials containing certain demographic information may not be considered anonymous, depending on the size of the population from which the materials or data are derived.
“Background Technology” means any and all products, services, processes, technologies, materials, software, data and other innovations that are created by you or a third party prior to or outside of this Project and that are to be used as part of the Project.
A Biospecimen is a quantity of tissue, blood, urine, or other human-derived material.
“Commercial purposes” means the sale, lease, license, or other transfer of the materials or modifications to a for-profit organization.
Commercial purposes: the sale, lease, license, or other transfer of the material or modifications to a for-profit organization. Commercial purposes shall also include uses of the material or modifications by any organization, including recipient, to perform contract research, to screen compound libraries, to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the material or modifications to a for-profit organization. However, industrially sponsored academic research shall not be considered a use of the material or modifications for commercial purposes per se, unless any of the above conditions of this definition are met.
General Obligations to maintain Confidentiality - During implementation of the action and for [Number of] years after the period set out in this agreement, the parties must keep confidential any data, documents or other material (in any form) that is identified as confidential at the time it is disclosed (“confidential information”).
Confidential Information - All technology and know-how disclosed by one party (the “Disclosing Party”) to another party (the “Receiving Party”) hereunder (“Confidential Information”) shall be used solely and exclusively by Receiving Party in a manner consistent with the licenses granted hereunder and the purposes of this Agreement as stated in the preamble and recitals hereto; maintained in confidence by the Receiving Party; and shall not be disclosed to any non-party or used for any purpose except to exercise its rights and perform its obligations under this Agreement without the prior written consent of the Disclosing Party, except to the extent that the Receiving Party can demonstrate by competent written evidence that such information: (a) is known by the Receiving Party without obligations of confidentiality at the time of its receipt and, not through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s business records; (b) is in the public domain other than as a result of any breach of this Agreement by the Receiving Party; (c) is subsequently disclosed to the Receiving Party on a non-confidential basis by a third party who may lawfully do so; or (d) is independently discovered or developed by the Receiving Party without the use of Confidential Information provided by the Disclosing Party.
Confidential Information means, (i) all information provided at any [agreement-associated] Meeting with respect to any aspect of a 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 (ii) all recorded information, including data marked “Confidential” or bearing a similar legend.
Data means recorded information used or generated in the performance of [project]. This agreement defines the following categories of data: (i) 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;(ii) Non-Standardized Data: all data not resulting from Standardized Assays other than Comparative Data; (iii) Comparative Data: all Data resulting from comparative evaluation of Non-Standardized Data or Standardized Data produced by a [Member].(iv) 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.
“Funded Development” means any and all products, services, processes, technologies, materials, software, data and other innovations (including modifications, improvements and further developments to Background Technology) to be created by [grantee] or a third party under this Project.
Examples of Funded Developments include, but are not limited to, the following: Products: compounds, formulations, diagnostics, therapeutics, prophylactics, and devices; Services: treatments, delivery systems, communications, and infrastructure developments; Processes: methods, formulae, and algorithms; Technologies: platforms, mechanisms, and tools• Materials: drawings, analysis, curriculum, guidelines, and policy recommendations; Software: code, development kits, and applications; Data: [raw or compiled]; Other Innovations
(Past consultations heard this term may need defining but no examples have been identified to date.)
“Information” means the anonymized information relating to the Materials as supplied by the [Supplier] to Recipient.
“Background”: any information, techniques, Know-how, software and materials (regardless of the form or medium in which they are disclosed or stored) that are provided by one party to another for use in the Project (whether before or after the date of this Agreement), except any Result.
“Background” means 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.”
Intellectual Property Rights (IPRs): all present and future intellectual property rights including but not limited to patents, trade and service marks, design rights, copyright, database rights, trade secrets and know-how, in all cases whether registered or not or registerable, and including all registrations and applications for registrations of any of these and rights to apply for the same as well as any renewals, extensions, continuations, combinations or divisions thereof, and all rights and forms of protection of a similar nature or having equivalent or similar effect to any of these anywhere in the world.
“Invention” means any software or new discovery, improvement or invention, including any Modification, made by the Recipient through the use of the Materials and/or the Confidential Information
“Materials” means all types of tangible chemical, biological and/or physical materials. (§1 Definition) Materials are transferred for the performance of the Action from “Providing Beneficiary” to “Recipient Beneficiary.”
“ORIGINAL MATERIAL” means the material transferred subject to this Agreement. A description of the material being transferred will be specified in an implementing letter. “Material” includes original material, progeny, and unmodified derivatives. The material does not include modifications or other substances created by the recipient through the use of the material, which are not modifications, progeny, or unmodified derivatives.
Human materials are substances including, but not limited to, blood, urine, stool, saliva, hair, nail clippings, skin, and any other associated bio-products obtained from human research participants or patients or healthy persons.The materials being transferred/ exchanged must be fully described, including a description of derivative products, if any. Quantities must be specified and appropriately packaged.
“Modifications” means substances created by the recipient that contain or incorporate the material.
Nonprofit organization(s): a university or other institution of higher education or an organization of the type described in section 501(c)(3) of the internal revenue code of 1954 (26 u.s.c. 501(c)) and exempt from taxation under section 501(a) of the internal revenue code (26 u.s.c. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute. as used herein, the term also includes government agencies.
(Past consultations heard this term may need defining but no examples have been identified to date.)
“Progeny” means unmodified descendant from the material, such as virus from virus, cell from cell, or organism from organism.
“Provider” means the organization providing the original material. the name and address of this party will be specified in an implementing letter.“provider scientist” the name and address of this party will be specified in an implementing letter.
(Past consultations heard this term may need defining but no examples have been identified to date.)
“Recipient” means the organization receiving the original material. the name and address of this party will be specified in an implementing letter.“Recipient scientist” the name and address of this party will be specified in an implementing letter.
(Past consultations heard this term may need defining but no examples have been identified to date.)
Repository is the physical entity where the Research Materials will be stored and distributed following the Recipient’s approved processes and procedures.
(As opposed to commercial development - past consultations heard this term may need defining but no examples have been identified to date.)
“Results” means the results of the work performed by the Recipient, including but not limited to virus isolates, genetic sequences, data and information, analyses and conclusions.
“Result”: All information, Know-how, results, inventions, software and other Intellectual Property identified or first reduced to practice or writing in the course of the Project.
(Past consultations heard this term may need defining but no examples have been identified to date.)
“Unmodified derivatives” means substances created by the recipient that constitute an unmodified functional subunit or product expressed by the original material.
How these terms are defined can have a notable impact on how the MTA relates to the overarching principles. For example, the definition of unmodified derivatives can affect benefit sharing Limiting the scope of the MTA to these materials (and not specifically addressing derivatives that have undergone ‘Modification’) could result in materials that might be important for commercial development falling outside of the provisions on benefit sharing.