PACT Collaborator definition

PACT Collaborator means a company that made available its Agent(s) for use in association with the PACT-Funded Trial Protocol(s). When the PACT-Funded Trial Protocol is also a NCI Clinical Trial Network Protocol, the PACT Collaborator will also be an NCI Collaborator.
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Examples of PACT Collaborator in a sentence

  • In all oral presentations or written publications arising from the use of the Human Material from PACT-Funded Trials, PACT-Funded CIMAC Data, or PACT Results, the PACT team (including NCI and industry sponsors), CIMAC-CIDC, PACT Collaborator, and Provider will be acknowledged unless requested otherwise.Acknowledgement language for the PACT team will be provided to each Supplemental Biomarker Analysis Team.

  • However, information proprietary to the PACT Collaborator may be redacted at the PACT Collaborator’s request.

  • All manuscripts, abstracts, presentations, or posters using data and/or materials from clinical trials using Agent(s) provided by PACT Collaborator(s), will be sent to FNIH, c/o Stacey Adam at sadam@fnih.org and Jenny Peterson-Klaus at jpeterson- klaus@fnih.org for advisory review and comment by the PACT JSC and the PACT Collaborator no later than thirty (30) days before submission for proposed manuscripts and seven (7) days before disclosure for proposed abstracts or presentations.

  • The PACT Collaborator shall have the right to request that publication be delayed for up to an additional thirty (30) days in order to ensure that the PACT Collaborator’s confidential and proprietary data, in addition to the PACT Collaborator(s)’s intellectual property rights, are protected.

  • Prior to the end of the Embargo Period, FNIH will contact the PACT Collaborator to see if an extension of the Embargo Period for regulatory filing is required.

  • Note: While PACT Collaborator comments are not binding, authors must address all comments made by PACT Collaborator.

  • Since most PACT-Funded Trials will use Human Material from existing approved clinical trials from other Clinical Trial Networks/Clinical Research Sites, the CIMAC-CIDC data sharing plans must also comply with the existing data release timelines within these existing Protocol agreements between the Clinical Trial Team and the PACT Collaborator.

  • Following publication of the supplementary biomarker data in a manuscript, the PACT Collaborator may perform additional analyses for internal use or that are planned for publication, including via manuscripts, abstracts, or corporate publications, of their PACT-Funded CIMAC Data in coordination with and approval from the Supplementary Biomarker Analysis Team, and notification to the PACT JSC.

  • The Embargo Period may be extended on PACT Collaborator request to PACT JSC.

  • As appropriate, Provider will share Clinical Data, PACT-Funded CIMAC Data, and PACT Results with PACT Collaborator with notification to PACT JSC/FNIH.

Related to PACT Collaborator

  • Collaborator An individual who is not under the direct supervision of the PI (e.g., not a member of the PI’s laboratory) who assists with the PI’s research project involving controlled-access data subject to the NIH GDS Policy. Internal collaborators are employees of the Requester and work at the same location/campus as the PI. External collaborators are not employees of the Requester and/or do not work at the same location as the PI, and consequently must be independently approved to access controlled-access data subject to the NIH GDS Policy.

  • Collaborating physician means the physician who,

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • Therapeutic school means a residential group living facility:

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Development Services “Target Market”; “Investment Areas”; and “Targeted Populations” have the meanings ascribed to such terms in 12 C.F.R. 1805.104.

  • Research Materials means all tangible materials other than Subject Data first produced in the performance of this CRADA.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Pfizer shall have the meaning set forth in the preamble.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Product Patents means any Patent Controlled or owned by Quoin in the Territory that, absent the license in Section 2.1, would be infringed by the importation, sale, or use of the Product in the Territory by a third party.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Collaboration Patents means any and all Patents that claim or cover any of the Collaboration Know-How.