Ongoing Development Activities Sample Clauses

Ongoing Development Activities. Except as set forth below, Xxxxxxx shall have no further obligation to conduct Development activities with respect to a Compound or Product after the date of notice of termination. After the Opt-In Date, if Xxxxxxx is conducting any Development activity with respect to a Compound or Product on the date of notice of termination, then Theravance shall notify Xxxxxxx within [***] after the notice of termination: (i) with regard to any Clinical Trial, whether Theravance elects to have Xxxxxxx (A) complete such Clinical Trial on behalf of Theravance (unless Xxxxxxx reasonably believes there is a Material Safety Issue that should prevent the continuation of such Clinical Trial), (B) wind down such Clinical Trial as soon as practicable, subject to compliance with ethical and legal requirements or (C) transfer such Clinical Trial to Theravance as soon as practicable; and (ii) with regard to any other Development activity, whether Theravance elects to have Xxxxxxx wind down or transfer such activity to Theravance. Notwithstanding the foregoing, if Xxxxxxx terminates this Agreement pursuant to Section 11.3, 11.4 or 11.5, then this Section 11.6(b) shall not apply and Xxxxxxx shall wind down any ongoing Development activities as soon as practicable after the date of notice of termination, subject to compliance with ethical and legal requirements; and each Party shall bear its own expenses incurred pursuant to such wind down. After the Opt-In Date:
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Ongoing Development Activities. Notwithstanding anything in this Agreement to the contrary, including Section 2.8 and this Section 4.1, (i) G1 shall continue until completion, as the Clinical Trial sponsor, the Clinical Trials [***], and (ii) G1 shall use [***] to wind down any pre-clinical studies in respect of the Licensed Compound or Licensed Product that are ongoing as of the Effective Date, [***] in each case ((i) and (ii)) which activities shall not be deemed to be a breach of G1’s obligations under Section 2.8. At Licensee’s request, G1 shall permit [***] representative of Licensee to join as an observer at any of G1’s or its Affiliate’s external meetings, teleconference calls or other material activities directly related to such Clinical Trials, including all meetings or teleconference calls with Regulatory Authorities directly related to such Clinical Trials, in all cases subject to the terms and conditions of all applicable agreements with the applicable Clinical Trial sites (including confidentiality obligations therein). Further, on a [***] basis (or such other frequency as the Parties may mutually agree) until the completion of such Clinical Trials, such Licensee representative shall meet with members of G1’s clinical operations team to discuss the progress of such Clinical Trials. [***] in connection with the Clinical Trials described in clause (i) above. Within [***] after the end of each [***] during which such Clinical Trials are ongoing, G1 will provide an invoice to Licensee setting forth in reasonable detail the Out-of-Pocket Costs incurred in connection with such Clinical Trials during such [***]. Such [***] invoices will be accompanied by available supporting documentation, receipts or related information to the extent necessary to verify such incurred Out-of-Pocket Costs for a particular [***]. Within [***] after its receipt of such [***] invoice, [***] the undisputed amounts set forth in such [***] invoice. For purposes of this Section 4.1(b), “Out-of-Pocket Costs” means, with respect to activities performed by or on behalf of G1 after the Effective Date in connection with the Clinical Trials described in clause (i) above, specifically identifiable direct expenses paid or payable by G1 or its Affiliates to Third Parties and incurred to conduct such activities, including payments to contract personnel (including contractors, consultants and subcontractors).
Sample 1

Related to Ongoing 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 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.

  • 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 Plan As defined in Section 3.2(a).

  • 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 Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

  • 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.

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