Development and Regulatory Meetings Sample Clauses

Development and Regulatory Meetings. The Parties agree to meet on a quarterly basis or as reasonably requested by the MPP, to review development and filing status and also regarding such reports concerning Licensed Product, Product and/or the Compound. MPP agrees that information contained in quarterly and other such reports shall be treated as Confidential Information of Licensee; provided, however, that such information may be shared with Pfizer (with Pfizer treating such reports as Confidential Information) and that aggregated data may be publicly disclosed by MPP. Licensee shall, at its own expense and using its own resources, and using all due care in accordance with the prevailing standard of professional competence in a regulatory function in the pharmaceutical industry, obtain, maintain and operate in compliance with (a) the Key Approvals and (b) all other authorizations, licenses, permits, registrations, and regulations which may from time to time be required by any Agency for Licensee to import, manufacture, promote, and sell the Licensed Product in the Territory. Licensee will not sell Licensed Product in any country in the Territory prior to obtaining both local health Agency approval or authorization in the country in the Territory where the Licensed Product is sold and Commercialized and relevant approval or authorization for the manufacture of Licensed Product in the country of manufacture. Licensee shall provide quarterly written reports to MPP notifying MPP about the registration process and providing MPP with any other information in this regard that MPP may reasonably require which such reports may be shared with Pfizer (with Pfizer treating such reports as Confidential Information). Licensee shall not transfer, assign, or otherwise convey any of the authorizations, registrations, or permits related to the Licensed Product, as set forth above in this Section 3, to any Affiliate without the prior written notice to MPP and Pfizer.
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Development and Regulatory Meetings. The Parties agree to meet on a quarterly basis or as reasonably requested by the MPP, to review development and filing status and also regarding such reports concerning Licensed Product and/or the Compound. MPP agrees that information contained in quarterly and other such reports shall be treated as Confidential Information of Licensee; provided, however, that such information may be shared with Shionogi (with Shionogi treating such reports as Confidential Information) and that aggregated data may be publicly disclosed by MPP. Licensee shall, at its own expense and using its own resources, and using all due care in accordance with the prevailing standard of professional competence in a regulatory function in the pharmaceutical industry, obtain, maintain and operate in compliance with
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Related to Development and Regulatory Meetings

  • Investigatory Meetings A. An employee required to attend an investigatory meeting shall receive advance notice of such meeting. Such notice shall include:

  • 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 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.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • 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.

  • Preparatory Contract Negotiations Meetings Where operational requirements permit, the Employer will grant leave without pay to an employee to attend preparatory contract negotiations meetings.

  • Project Managers; Meetings 10.1 Promptly following the Effective Date, each Party shall designate a Project Manager responsible for coordinating the Party’s Work and shall provide the other Party with a written notice containing the name and contact information of such Project Manager (“Project Manager”). In no event shall any Project Manager be authorized to amend or modify the provisions of this Agreement. Each Party may change its Project Manager, from time to time, by written notice to the other Party.

  • 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.

  • Additional Information for Product Development Projects Outcome of product development efforts, such copyrights and license agreements. • Units sold or projected to be sold in California and outside of California. • Total annual sales or projected annual sales (in dollars) of products developed under the Agreement. • Investment dollars/follow-on private funding as a result of Energy Commission funding. • Patent numbers and applications, along with dates and brief descriptions.  Additional Information for Product Demonstrations: • Outcome of demonstrations and status of technology. • Number of similar installations. • Jobs created/retained as a result of the Agreement.

  • Negotiations Meetings Negotiations meetings between said bargaining committees shall be private and scheduled for mutually satisfactory times and place(s). Both parties may utilize the services of consultants during the negotiation process. Only bargaining committee members, consultants, and other individuals mutually agreed to between the bargaining committees shall be present in the negotiating sessions.

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