Conduct of the Development Program Sample Clauses

Conduct of the Development Program. From the date hereof until the Closing Date, Aradigm shall conduct the Development Program in accordance with the Development and License Agreement in the ordinary course consistent with past practices and shall use its best efforts to preserve intact the business organizations and relationships with third parties relevant to the Development Program and to keep available the services of the Development Program Employees. Without limiting the generality of the foregoing, from the date hereof until the Closing Date, Aradigm will not:
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Conduct of the Development Program. 2.2.1. As between the Parties, subject to Section 2.2.2 and Section 2.2.3, unless otherwise agreed by the Parties in writing, Xxxxxxx shall be the Party conducting the Development Program. Xxxxxxx shall: (a) use Commercially Reasonable Efforts to conduct the Development Program, at its sole cost and expense, under the oversight of the JDC, in accordance with the Initial Development Plan (including the timelines set forth therein); and (b) conduct the Development Program in good scientific manner and in compliance, in all material respects, with all Applicable Law. Without limiting the foregoing, Xxxxxxx shall comply with its Sponsor Responsibilities in connection with the Xxxxxxx Study and nothing in this Agreement shall be construed to prohibit any such compliance.
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Conduct of the Development Program. With respect to each Licensed Compound, Dainippon will conduct a Development Program designed to obtain Regulatory Approval in the Territory.
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Conduct of the Development Program. (a) Xxxxxxx will conduct the Development Program under the direction of the Steering Committee. Xxxxxxx shall keep the Steering Committee fully informed on a reasonable basis of the development of the Product, including but not limited to periodic written updates on the progress of each filing with a Regulatory Authority.
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Conduct of the Development Program. Each of the parties shall use commercially reasonable efforts to perform its obligations under each Development Plan, including allocation of sufficient time, effort, equipment and facilities necessary to perform its obligations under such Development Plan and use of personnel with sufficient skills and experience as are required to accomplish such party's responsibilities under such Development Plan. Each party shall conduct its responsibilities under such Development Plan in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations and all applicable good laboratory practices. Each party shall immediately notify the other in writing of any deviations by such party from applicable regulatory or legal requirements in the course of performing its responsibilities under such Development Plan. Each party hereby covenants to the other that neither such party nor any of its employees or contractors who perform any services under such Development Plan will have been debarred, or convicted of a crime for which a person can be debarred, under 21 U.S.C. Section 335a of the FDCA, and each party covenants that it will not employ or otherwise use in any capacity the services of any person debarred under 21 U.S.C. Section 335a of the FDCA in performing [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH A SERIES OF THREE ASTERISKS IN BRACKETS [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] any work under such Development Plan. If during the Development Term, a party or any individual or entity employed or otherwise used by such party in performing work under a Development Plan becomes debarred or disqualified, or receives notice of an action or threat of an action with respect to debarment or disqualification, such party shall immediately notify the other party and such party, or such individual or entity, as applicable, shall no longer be allowed to perform services under any Development Plan.
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Conduct of the Development Program 
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Related to Conduct of the Development Program

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

  • Conduct of Research The Parties shall use Diligent Efforts to conduct their respective tasks, as assigned under the Research Plan, throughout the Mode of Action Program and shall conduct the Mode of Action Program in good scientific manner, and in compliance in all material respects with the requirements of applicable laws, rules and regulations and all applicable good laboratory practices to attempt to achieve their objectives efficiently and expeditiously.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members.

  • 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.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK Firms and/or individuals that assisted in the development or drafting of the specifications, requirements, statements of work, or solicitation documents contained herein are excluded from competing for this solicitation. This shall not be applicable to firms and/or individuals providing responses to a publicly posted Request for Information (RFI) associated with a solicitation.

  • Research Program 2.1 University will use reasonable efforts to conduct the Research Program described in Attachment A which is hereby incorporated in full by reference (“Research Program”), and will furnish the facilities necessary to carry out said Research Program. The Research Program will be under the direction of _____________________ (“Principal Investigator”), or his or her successor as mutually agreed to by the Parties and will be con­ducted by the Principal Investigator at the University.

  • 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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