Selection of Development Compounds Sample Clauses

Selection of Development Compounds. Based upon the results generated during the Research Collaboration and the evaluation of Focused Library Compounds and Lead Compounds, the JRC may, from time to time, nominate a Focused Library Compound, Lead Compound or Compound for consideration by Trimeris as a potential Development Compound, and shall inform Trimeris of such recommendation. Notwithstanding the recommendation of the JRC, Trimeris shall have the right, in its sole discretion, to designate any Active, Focused Library Compound, Lead Compound or Compound as a Development Compound during the term of this Agreement. CRL acknowledges and agrees that the final decision as to whether or not to designate any Active, Focused Library Compound, Lead Compound or Compound as a Development Compound shall rest with Trimeris, and that such decision will be made by Trimeris in accordance with Trimeris’ standard internal procedures for the nomination and selection of a Development Compound. Trimeris shall give CRL written notice of its designation of a Compound as a Development Compound; and a Focused Library Compound, Lead Compound or a Compound shall not be deemed a Development Compound unless so designated by Trimeris by such written notice. Trimeris agrees not to undertake any IND-Enabling Studies with respect to a particular Focused Library Compound, Lead Compound or Compound until such compound has been designated a Development Compound in accordance with this Section 2.4.4(b); provided however, that Trimeris may undertake to perform non-GLP ADMET studies on Compounds in order to determine whether or not it shall designate a Compound as a Development Compound. All Development Compounds shall be made solely available to Trimeris on an exclusive basis, and such Development Compounds shall not be, unless the prior written consent of Trimeris is obtained, included in any CRL Library supplied to a Third Party by CRL under a separate agreement.
Sample 1Sample 2
AutoNDA by SimpleDocs
Selection of Development Compounds. Within one hundred eighty days ---------------------------------- after completion of the Initial Animal Studies pursuant to Section 2.2.4 (including testing required on additional Candidate Compounds), Heska shall select one or more Candidate Compounds as Development Compounds for use in the Primary Field. If the results of the Initial Animal Studies indicate that additional testing needs to be completed before Heska is able to select Development Compounds (including testing required on additional Candidate Compounds), Heska shall so indicate to 3DP in writing and shall use reasonably commercial efforts to conduct such additional required testing promptly; in such event, the foregoing one hundred eighty day period will commence at the completion of such additional studies. Heska shall provide 3DP with written notice during the applicable time period of the Candidate Compounds it has selected as Development Compounds, and shall indicate the non-human animal species in which it intends to use such Development Compounds. In the event that Heska selects a Development Compound for use in any additional non-human animal species, it shall immediately notify 3DP in writing of such decision. If Heska fails to select any Development Compounds within one hundred eighty days after completion of all required Initial Animal Studies, Heska shall provide to 3DP the scientific, technical, regulatory or other substantial reasons for Heska's inability, in such time period, to select at least one Development Compound, along with a written plan for overcoming the problems caused thereby, selecting a Development Compound and commencing Development, and shall use all reasonable efforts to do so as soon as practicable thereafter. If Heska fails to comply with the foregoing in such time frame, then at 3DP's election and upon written notice to Heska, all rights of Heska in the Candidate Compounds shall revert to 3DP and Heska will have no further rights thereto. If, during such time period, Heska has selected at least one Development Compound for Development in one non-human animal species, Heska may decide at any time during the term of this Agreement to engage in Development of such Development Compound for use in the Fields in additional non-human animal species, or select Subsequent Development Compounds for Development in the Fields, provided that Heska shall provide 3DP with written notice immediately upon reaching such decision.
Sample 1Sample 2
Selection of Development Compounds. When a Research Compound has been demonstrated to meet the Success Criteria, the Compound shall be designated a Development Compound. Within ninety (90) days after the designation of a Development Compound by the Parties, the OC shall approve a Product Plan for such Development Compound. The Product Plan shall include [******************************************************************************* ******************************************************************************** *************************************************************************] Each Product Plan should incorporate those elements set forth in Attachment 3.3. [******************************************************] The timing and calculations for the typical Product Plan budget is contained in Attachment 3.1 as an example. The OC will have complete authority to adopt all Product Plans. 3.4.
Sample 1
Selection of Development Compounds. (a) The PC or either Party may propose to the OC that a Research Compound be further developed as a Development Compound, if such Compound has undergone sufficient testing to demonstrate that it has met the Success Criteria established pursuant to a Research Project Plan.
Sample 1
Selection of Development Compounds. (a) At the time that the Parties have performed sufficient research and preclinical testing of a Research Compound and such testing shows that the Research Compound may have utility in the Field and has met the Research Plan's predetermined Success Criteria for such Research Compound to be considered a Development Compound, so that the JMC reasonably determines that the Research Compound should undergo safety assessment and other preclinical development activities to determine whether to commence clinical studies with respect thereto (and thereby such Research Compound being designated as a Development Compound), then further research, development, and commercialization of the Development Compound will be conducted in accordance with this Agreement.
Sample 1

Related to Selection of Development Compounds

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to commercialize a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries. If Novartis commercializes a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries, Novartis will be deemed to satisfy all diligence obligations with respect to such Profile.

  • Research Collaboration Upon FibroGen’s request, the Parties will discuss conducting a research program funded by AstraZeneca and directed toward franchise enhancement and lifecycle management for HIF Compounds or other topics that the Parties determine relevant to the Products and the Field. Upon agreement on the terms of such research program, the Parties will enter into a separate agreement or amend this Agreement accordingly.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)

Time is Money Join Law Insider Premium to draft better contracts faster.