Performance of Development Activities Sample Clauses

Performance of Development Activities. (a) Appendix A sets forth a development plan (the "Development Plan"), ---------- including a series of milestones for conducting the activities described in this Section 3 (collectively, the "Development Activities"). Details regarding Phase 3 of the Development Plan shall be developed by the Steering Committee and set forth in an amendment to the Development Plan approved in accordance with Section 3.3(b). LifeSensors will undertake only those Development Activities that are set forth in the Development Plan, as it may be amended from time to time by the Steering Committee in accordance with Section 2.2. Each of Embrex and LifeSensors will devote not less than the resources specified in the Development Plan, as amended from time to time in accordance with this Section 3.3, to conducting its respective Development Activities, allocating such resources and conducting such activities substantially on the schedule set forth in and otherwise in accordance with the Development Plan, except to the extent otherwise provided on Appendix A. In particular, during Phase 2 of the ---------- Development Plan, LifeSensors agrees that no fewer than **** of its full-time employees will be dedicated to the project.
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Performance of Development Activities. Each Party shall, with respect to all Development activities for which such Party is responsible under this Agreement, provide, directly or indirectly through its Affiliates, sub/licensees, Sublicensees, or Subcontractors, all materials, facilities, and resources necessary for it to perform such Development activities with reasonable care and skill, consistent with sound and ethical business and scientific practices, in compliance with all Applicable Laws, including GCP, GVP, GMP and GLP, and otherwise in accordance with the terms of this Agreement. Each Party shall devote the efforts of suitably qualified and trained employees and personnel capable of carrying out the Development activities for which such Party is responsible to a professional workmanlike standard. Without prejudice to any other remedies either Party may have, if a Party notifies the other Party that it has reasonable grounds to suspect that a breach of the other Party’s obligations under this Section 4.2 (Performance of Development Activities) has occurred or is reasonably likely to occur, the other Party shall (i) consider in good faith any comments or concerns provided by such Party in such notice with respect to such breach or potential breach and (ii) take commercially reasonable steps to remedy, in all material respects, any actual breach and to avoid any potential breach as soon as reasonably practicable.
Performance of Development Activities. Each Party will perform the Development Activities for which such Party is responsible under the Study Plan and will use Commercially Reasonable Efforts to perform such activities in accordance with the timelines set forth therein; provided that Fortis’s performance of its Development Activities will be subject to FibroGen’s compliance with its funding obligations with respect to the Development Fees. Each Party will use Commercially Reasonable Efforts to cooperate with the other Party in carrying out the Development Activities in accordance with the Study Plan. Each Party will, and will require its Affiliates and Subcontractors to, comply with all Applicable Laws in its and their conduct of the Development Activities under the Study Plan, including where appropriate GMP, GCP and GLP (or similar standards). Notwithstanding anything to the contrary, FibroGen may not initiate, and no Study Plan will include, any Phase 3 Clinical Trial or any Clinical Trial other than a FibroGen Clinical Study or Fortis Clinical Study, with respect to any of the Products or Modified Products unless with the prior written consent of Fortis [*]. [*].
Performance of Development Activities. (a) Each Party shall undertake its development activities and other obligations under the applicable Statement of Work (such activities and obligations with respect to a Party as expressly identified in a Statement of Work, such Party’s “Services” and any resulting products or deliverables with respect to a Party as expressly identified in a Statement of Work, such Party’s “Deliverables”) in accordance with and subject to the terms and conditions of this Agreement and the applicable Statement of Work. Each Party will use commercially reasonable efforts to meet, or cause its Subcontractors to meet, the timelines and budgets set forth in this Agreement and the Statements of Work in such Party’s (or its Subcontractors’) performance of its Services.
Performance of Development Activities. Each Party shall perform any and all of its Development activities with respect to the Programs in accordance with the applicable Development Plan, in good scientific manner and in compliance with all Applicable Law, including applicable national and international (e.g., ICH, GCP, GLP, and GMP guidelines), informed consent and institutional review board regulations, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects.
Performance of Development Activities 

Related to Performance of Development Activities

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

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

  • 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).

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • 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.

  • Development Plan As defined in Section 3.2(a).

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

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