Pre-Commercialization Activities definition

Pre-Commercialization Activities means, with respect to each Product, all preclinical and clinical activities designed to obtain Regulatory Approval of such Product, its Manufacture and its Commercialization, up to and including the obtaining of Regulatory Approval of such Product, including regulatory toxicology studies, statistical analysis and report writing, Clinical Trial design and operations, preparing and filing Drug Approval Applications, and all regulatory affairs related to the foregoing.
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Pre-Commercialization Activities shall include but not be limited to Phase 1, 11 and III Clinical Testing and any other such activities deemed necessary by government regulatory bodies other than Non-clinical Research Activities.
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Pre-Commercialization Activities has the meaning set forth in Section 4.3(a).
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Examples of Pre-Commercialization Activities in a sentence

  • If the Parties mutually agree upon a Pre-Commercialization Plan, then Intec Pharma shall conduct all of the Pre-Commercialization Activities set forth therein in accordance with the Pre-Commercialization Plan.

  • Our experiment uses the metastable a(1)3Σ+stateof the transition.

  • Both admitted identifying with the prosecutor, Harry Dorfman, as "their lawyer" in the case.

  • BioLineRx shall conduct all BioLineRx Pre-Commercialization Activities in accordance with the Pre-Commercialization Plan and standard scientific principles and under the oversight of the JSC (or if the JSC is disbanded as set forth in Section 3.3).

  • Such Pre-Commercialization Plan shall include a budget covering all Pre-Commercialization Activities set forth therein.

  • In addition, BioLineRx shall be responsible for the BioLineRx Pre-Commercialization Activities.

  • For clarity, BioLineRx shall not have the right to engage subcontractors for the performance of the BioLineRx Pre-Commercialization Activities without the prior written consent of Cypress, not to be unreasonably withheld, conditioned or delayed; provided that, as of the Execution Date, Cypress has consented to the engagement of [...***...] for the [...***...] Study.

  • For clarity, nothing in this Agreement shall create any obligation on the part of Biogen to conduct Pre-Commercialization Activities for, seek Regulatory Approval of, Manufacture or Commercialize any Product (including any Collaboration Product) in any country in the Territory.

  • Any decision by Biogen (a) not to pursue the Pre-Commercialization Activities, Regulatory Approval, Manufacture or Commercialization of any Product (including any Collaboration Product), or (b) to pursue the Pre-Commercialization Activities, Regulatory Approval, Manufacture or Commercialization of any Product (including any Collaboration Product) in collaboration with a Third Party, shall not constitute a breach of this Agreement.

  • For clarity, BioLineRx shall not have the right to engage subcontractors for the performance of the BioLineRx Pre-Commercialization Activities without the prior written consent of Cypress, not to be unreasonably withheld, conditioned or delayed; provided that, as of the Execution Date, Cypress has consented to the engagement of Xxxxxxxxx Xxxxxxx for the Xxxxxxx Study.

Related to Pre-Commercialization Activities

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • 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.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Development Program means the implementation of the development plan.

  • Development Plan has the meaning set forth in Section 3.2.

  • Research Program has the meaning set forth in Section 2.1.

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

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • 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.

  • Development Works means the external development works and internal development works on immovable property;

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • licensed activities means things authorised to be done by the licence

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Extracurricular activities means: a voluntary activity sponsored by the school or local education agency or an organization sanctioned by the local education agency. Extracurricular activities include, but are not limited to, preparation for and involvement in public performances, contests, athletic competitions, demonstrations, displays, and club activities.

  • 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.

  • 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)).

  • Power production activities means any business operation that involves a project commissioned by the government of Iran whose purpose is to facilitate power generation and delivery, including, but not limited to, establishing power-generating plants or hydroelectric dams, selling or installing components for the project, providing service contracts related to the installation or maintenance of the project, as well as facilitating such activities, including by providing supplies or services in support of such activities.

  • Commercialized shall have corresponding meanings.