Collaboration Product Development Plan definition

Collaboration Product Development Plan means, on a Collaboration Product-by-Collaboration Product basis, a detailed research plan describing the Research and Development to be performed, the estimated timelines for carrying out the Research and Development and setting out in detail the roles and responsibilities of each Party in connection with the Research, Development and Manufacture of the Collaboration Products. Each initial Collaboration Product Development Plan in respect of an AZ Dev Product, and each initial Collaboration Product Development Plan in respect of a CoDev Product, shall be directed towards achievement of Lead Candidate. The initial Collaboration Product Development Plans will be prepared by the Parties as set forth in Section 4.3.3.1.
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Examples of Collaboration Product Development Plan in a sentence

  • Each Party shall provide to the other written reports regarding the progress and results of their activities under the Lead Product Development Plan and each Collaboration Product Development Plan through the JSC.

  • The JDC shall be a subcommittee of the JSC and shall be responsible for implementing the Lead Product Development Plans and Collaboration Product Development Plan subject to the terms and conditions of this Agreement.

  • Pieris and AstraZeneca shall use Commercially Reasonable Efforts to perform their respective activities contemplated by this Agreement, as may be agreed upon in any subsequent written agreements with respect to the subject matter hereof, including but not limited to any activities under the then-current Lead Product Development Plan, each Collaboration Product Development Plan and any other plans or tasks approved by the JSC.

  • AstraZeneca shall be obligated to keep Pieris informed of the progress of such efforts and relevant data generated under Section 4.8.3, but the Parties shall not update the Collaboration Product Development Plan for the AZ Dev Products after the Lead Candidate stage is reached.

  • The initial Collaboration Product Development Plan shall also include preliminary Technical Candidate Drug Criteria with respect to each Product, which criteria shall be finalized and decided in accordance with Section 3.2.5.2(c)(iii).

  • The Lead Product Development Plan and each Collaboration Product Development Plan shall include details regarding Manufacture of the supply of each Product, as applicable including budget, until Marketing Approval of such Product.

  • Pieris will disclose to AstraZeneca all Anticalin proteins identified by Pieris or its Affiliates in connection with the applicable screening campaign that are specific to each Designated Target as determined by reference to the selectivity criteria set out in the Collaboration Product Development Plan.

  • The Conference (by resolution 10/10) further conditionally adopted resolutions 10/8A and 10/8B, also to be found in Appendix 1, enabling ministers, probationers and members and managing trustees to act under the Marriage Act in England and ministers, probationers and members to act under the Marriage Act in Scotland in response to the Conference’s decision upon resolution 10/8.

  • Upon reaching [***] for CoDev Products, the Parties shall update each Collaboration Product Development Plan from time to time and supervise the conduct of activities required in order to continue to Research, Develop and Manufacture such Product through the JSC.

  • Each Party shall (and shall cause its Affiliates, Sublicensees, subcontractors and consultants to) maintain complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it or on its behalf (including by its Affiliates, Sublicensees, subcontractors and consultants) under the Lead Product Development Plan and each Collaboration Product Development Plan.

Related to Collaboration Product Development Plan

  • 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.

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

  • 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 Plan has the meaning set forth in Section 3.2.

  • Development Program means the implementation of the development plan.

  • 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)).

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

  • 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 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;

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

  • Collaboration has the meaning set forth in Section 2.1.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

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

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

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

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • 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.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Research Program Term has the meaning set forth in Section 2.2.

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • 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 [***].

  • 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.

  • Licensed Compound means [***].