Initial Joint Development Project; Collaborative Development Efforts for the Joint Development Project Sample Clauses

Initial Joint Development Project; Collaborative Development Efforts for the Joint Development Project. (a) The initial Joint Development Project’s first priority as of the Effective Date will be to achieve Regulatory Approval of IFN-Lambda in the USA for the treatment of hepatitis C in accordance with the Joint Development Plan. For clarity, this may include the conduct of studies to support the Regulatory Approval of IFN-Lambda throughout the Joint Development Territory. (b) Each of the parties shall use its respective Reasonable Commercial Efforts during the Joint Commercialization Period to: (i) Develop each Licensed Product for Regulatory Approval by both the FDA and the European Commission, including performing its Party Development Tasks in accordance with the Joint Development Plan; and (ii) provide the other party with such information and other assistance as is reasonably required for such other party to perform its Party Development Tasks. (c) Each party shall be responsible for the selection and supervision of its personnel who are assigned any Party Development Tasks pursuant to this Agreement, and shall conduct all of its Development and regulatory activities in accordance with good scientific and clinical practice, and in compliance in all material respects with Applicable Law to achieve its objectives efficiently and expeditiously. (d) For the sake of clarity, BMS shall be responsible for all studies (and all Regulatory Filings and interactions with Regulatory Agencies) required solely for Regulatory Approval outside the Joint Development Territory. (e) Zymo, under the direction and oversight of the JDC, shall be responsible for conducting those studies assigned to it in the Joint Development Plan, and in accordance with the Joint Development Plan. Zymo shall provide BMS, via the JDC and Finance Contacts, with the opportunity to review and comment on any proposed agreement with any contract research organization for the conduct of such studies and any proposed amendments thereto, and any protocols included in such agreements (or attachments thereto). Zymo will not be obligated to perform any Party Development Tasks which it does not accept at the time the Joint Development Plan is approved by JEC Action. (f) For any pre-clinical and clinical studies conducted by Zymo pursuant to the Joint Development Plan and Annual Development Plan, Zymo shall prepare the applicable reports and support for Regulatory Filings in connection with such studies and provide same to BMS. For the ongoing Phase Ib trial, Zymo shall provide such reports to BMS for rev...
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Related to Initial Joint Development Project; Collaborative Development Efforts for the Joint Development Project

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

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

  • Research Project The findings of any research project, which would change the provisions of this Agreement will not be implemented until such changes are negotiated and agreed to by the parties.

  • Development Efforts 4.2.1 Hana shall use Commercially Reasonable Efforts to Develop each Product in the Territory (including carrying out its responsibilities under the Development Plan) to: (a) conduct or cause to be conducted the necessary and appropriate clinical trials as necessary to obtain and maintain Regulatory Approvals for each Product; and (b) prepare, file and prosecute or cause to be prepared, filed and prosecuted the Regulatory Submission for each Product. 4.2.2 Hana will provide INEX with written reports to keep INEX fully informed of the progress of the Development of each Product as follows: (a) at the close of each Calendar Quarter during the first twenty-four (24) months following the Effective Date of the Definitive Agreements; and (b) on or before June 31 and December 31 of each and every calendar year thereafter.

  • 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 Concession Area, including its abandonment.

  • Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

  • 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.

  • Collaboration 31.1 If the Buyer has specified in the Order Form that it requires the Supplier to enter into a Collaboration Agreement, the Supplier must give the Buyer an executed Collaboration Agreement before the Start date. 31.2 In addition to any obligations under the Collaboration Agreement, the Supplier must: 31.2.1 work proactively and in good faith with each of the Buyer’s contractors 31.2.2 co-operate and share information with the Buyer’s contractors to enable the efficient operation of the Buyer’s ICT services and G-Cloud Services

  • 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.

  • Research Program The term “

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