Development of Compounds Sample Clauses

Development of Compounds. In order for J&J or its Affiliates to initiate development of any Active Compound, J&J or its Affiliate will first: (a) have selected such Active Compound as a Selected Compound (which selection must have occurred in any event, as provided in Section 3.1, prior to the first anniversary of the end of the Research Term), and (b) provide written notice to Arena of the occurrence of Drug Evaluation Acceptance with respect to such Selected Compound and thereby notify Arena of J&J’s selection of the compound as a Development Compound. J&J will use Diligent Efforts to effect Drug Evaluation Acceptances of such number of Development Compounds as is commercially reasonable, as soon as practical. The JSC may also from time to time recommend that J&J select a particular Active Compound as a Selected Compound and as a Development Compound. J&J will consider any such recommendations in good faith, but the decision to select a particular Active Compound as a Selected Compound and to effect a Drug Evaluation Acceptance as to such Selected Compound will be made by J&J in its sole discretion, subject to its compliance with its diligence obligations under this Section and Section 3.7. Subject to the terms and conditions of this Agreement, J&J will control and be responsible for the worldwide development and for obtaining Regulatory Approvals of Development Compounds, including all pre-clinical work necessary to prepare and file INDs covering the Development Compounds (other than such work that is covered by the Research Plan), the planning and conduct of clinical trials and related studies of Development Compounds, the worldwide supply of Development Compounds in appropriate formulations and packaging for use in development through Regulatory Approval and the planning, filing and prosecution of applications for Regulatory Approval. J&J will use Diligent Efforts to conduct all the tasks and meet on a timely basis all the objectives and milestones under each Development Plan. At J&J’s request and expense, Arena will use reasonable efforts to contribute support in the area of clinical development to support J&J’s development of Development Compounds, any such efforts ********************************************* **************************************************************************************************** implementing and conducting each Early Development Plan, except as otherwise provided in Section 3.6, and for implementing and conducting each Late Stage Development Pl...
Sample 1
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Development of Compounds. Licensee may designate a maximum of two (2) Variants as Flu A Compound(s) and two (2) Variants as Flu B Compound(s) (as applicable) to progress into Development. Such designation for a Variant shall occur [***]. These Variants so designated will become the Licensed Compounds hereunder as of the date of MedImmune’s receipt of Licensee’s notice of designation and on the date the second Flu A and/or the Flu B Compound is designated the license granted under Section 2.1(i) to all other Variants (as they apply to the Flu A or Flu B Compound respectively) expires.
Sample 1
Development of Compounds. Beginning on the Closing Date, Amgen shall assume sole and full control, authority and responsibility for conducting, funding and pursuing all aspects of development, regulatory, manufacturing, and commercialization of Compound(s) in the Territory, including without limitation, modification or termination of such activities conducted by NPS prior to the Closing Date.
Sample 1
Development of Compounds 
Sample 1

Related to Development of 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.

  • 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.

  • 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 of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Research Collaboration (a) GSK hereby grants to Anacor a non-exclusive, non-royalty bearing license under the GSK IP, solely as and to the extent necessary or important to conduct activities for which Anacor is responsible under the Research Plans during the Research Collaboration Term.

  • 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.

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

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

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