Development Responsibility and Diligent Efforts Sample Clauses

Development Responsibility and Diligent Efforts. Under the direction of the JSC, THERAVANCE shall have overall responsibility for, and shall use Diligent Efforts in, the performance of all Development activities for the Licensed Product in the Field for the U.S., subject to the terms and conditions of this Agreement. THERAVANCE shall use Diligent Efforts to advance the Licensed Product in the Field through Development in the U.S. in accordance with the Development Plan. Specifically, but without limitation, THERAVANCE will be responsible for the following U.S. Development matters: i. conducting any remaining pharmaceutical science formulation and analytical work and accompanying quality control; ii. conducting any remaining pre-clinical and toxicology studies; iii. conducting clinical trials required to support the first NDA for the Licensed Product in the Field, including pivotal Phase 3 Clinical Trials; ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. iv. conducting all CMC work, including any activities necessary to support filing and approval of the Commercial manufacturing process, and, unless agreed by the Parties, obtaining supply of Licensed Product in the Field necessary to conduct the Development Plan for the U.S. and support filing of the first NDA for the Licensed Product in the Field; v. preparing and filing all U.S. Regulatory Filings necessary to conduct the Development Plan, including any INDs and the first NDA for the Licensed Product in the Field, and executing any activities necessary to include in such filings to support Commercialization of the Licensed Products in the Field; vi. leading interactions with FDA and responding to questions from FDA during review of such Regulatory Filings in accordance with Article 7; and vii. cooperating to transition to MYLAN (or its Affiliates) activities for which MYLAN has primary responsibility with respect to Licensed Products in the Field.
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Related to Development Responsibility and Diligent Efforts

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • 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.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Diligent Efforts Pfizer and Xenogen Cranbury each shall use reasonably diligent efforts to achieve the objectives of the Research Program. Xenogen Cranbury will use reasonably diligent efforts to achieve the objectives listed in the Research Plan and Pfizer will use reasonably diligent efforts to assist Xenogen Cranbury in such efforts.

  • 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 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.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • Joint Responsibility If the Seller determines that the Interface Problem is attributable partially to the design of a Warranted Part and partially to the design of any Supplier Part, the Seller will, if so requested by the Buyer, seek a solution to the Interface Problem through cooperative efforts of the Seller and any Supplier involved. The Seller will promptly advise the Buyer of such corrective action as may be proposed by the Seller and any such Supplier. Such proposal will be consistent with any then existing obligations of the Seller hereunder and of any such Supplier towards the Buyer. Such corrective action, unless reasonably rejected by the Buyer, will constitute full satisfaction of any claim the Buyer may have against either the Seller or any such Supplier with respect to such Interface Problem.

  • Client Responsibility For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.

  • Joint Efforts To the full extent permitted by law, neither this Agreement nor any ambiguity or uncertainty herein will be construed against any of the parties hereto, whether under any rule of construction or otherwise. On the contrary, this Agreement has been prepared by the joint efforts of the respective attorneys for, and has been reviewed by, each of the parties hereto.

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