Development Decision-Making Sample Clauses

Development Decision-Making. All matters regarding the Joint Development of the Licensed Product under the Global Product Development Plan shall be decided [***] by the JSC, subject to the provisions of Section 3.4.
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Development Decision-Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Development Plan shall be decided by consensus by the JDC, subject to Section 2.6.
Development Decision-Making. Except as otherwise expressly provided in this Agreement, all matters regarding the development activities hereunder shall be decided by AZ.
Development Decision-Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Early Clinical Development Program and the Late Clinical Development Program will be decided by unanimous agreement by the JDC.
Development Decision-Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Development Program shall be decided by [*], subject to the provisions of Sections [*].

Related to Development Decision-Making

  • Decision-Making The JDC shall make decisions unanimously, with each Party’s representatives collectively having one (1) vote and at least one (1) representative from each Party participating in such decision. In the event the JDC determines that it cannot reach an agreement regarding a decision within the JDC’s authority, then, within *** Business Days after such determination: (a) for any matter that is not a Critical Issue *** shall have the final decision making authority on such matter; and (b) for any matter that is a Critical Issue, the matter shall be referred to FivePrime’s Chief Executive Officer (or designee) and HGS’ Chief Executive Officer (or designee) for resolution. If such executives cannot resolve the matter within *** Business Days, then the Chief Executive Officer of *** (or designee) shall have the final decision making authority on such matter. Notwithstanding the foregoing, the Development Plan shall not be amended, without FivePrime’s prior written approval (which approval may be withheld in FivePrime’s sole discretion), to: (i) increase or materially change the nature of FivePrime-Conducted Trials or Other FivePrime-Conducted Activities; or (ii) require FivePrime to continue any FivePrime-Conducted Trial if FivePrime, in its reasonable judgment, decides not to continue such trial for any business, scientific, safety, efficacy, enrollment or ethical reason, provided that, in the event FivePrime so decides to discontinue such trial, HGS shall have no further obligation to reimburse FivePrime under Section 4.2(d) except with respect to costs *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. already incurred by FivePrime prior to such discontinuation and any and all standard close out costs incurred thereafter, and HGS shall have the right to continue such trial by itself at its expense. When *** make a final determination under this Section 3.4, that final determination must be consistent with the terms of this Agreement.

  • 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.

  • Development Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards the next clinical Development milestone or approval milestone, as described in Sections 7.4.2 or 7.4.3, respectively. If Novartis (itself or through its Affiliates or sublicensees) fails to dedicate commercially reasonable efforts, during any [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards such next milestone, then any dispute regarding Novartis’ failure of development diligence with respect to such Profile shall be resolved in accordance with Article 13.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

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

  • Independent Due Diligence and Decision Making Each Consenting Stakeholder hereby confirms that its decision to execute this Agreement has been based upon its independent investigation of the operations, businesses, financial and other conditions, and prospects of the Company Parties.

  • Independent Decision The Investor is not relying on the Issuer or on any legal or other opinion in the materials reviewed by the Investor with respect to the financial or tax considerations of the Investor relating to its investment in the Shares. The Investor has relied solely on the representations and warranties, covenants and agreements of the Issuer in this Agreement (including the exhibits and schedules hereto) and on its examination and independent investigation in making its decision to acquire the Shares.

  • Claim Decision Upon receipt of such claim, the Plan Administrator shall respond to such claimant within ninety (90) days after receiving the claim. If the Plan Administrator determines that special circumstances require additional time for processing the claim, the Plan Administrator can extend the response period by an additional ninety (90) days for reasonable cause by notifying the claimant in writing, prior to the end of the initial ninety (90) day period, that an additional period is required. The notice of extension must set forth the special circumstances and the date by which the Plan Administrator expects to render its decision. If the claim is denied in whole or in part, the Plan Administrator shall notify the claimant in writing of such denial. The Plan Administrator shall write the notification in a manner calculated to be understood by the claimant. The notification shall set forth:

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • 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.

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