Supplemental Studies Sample Clauses

Supplemental Studies. Roche shall have responsibility for the conduct of all Clinical Studies for Licensed Products in the Field in the Territory pursuant to the Development Plan other than Supplemental Studies. In addition, after the first Regulatory Approval for a Licensed Product, to the extent that (a) a Party desires to conduct any Clinical Studies in a Label Pursuit for such Licensed Product that is not included in the Development Plan, (b) a Party desires to conduct any Clinical Studies for such Licensed Product that are specific to a Party’s portion of the Territory, or (c) a Party desires to conduct any Post-Marketing Studies or other post-marketing commitments as mandated or agreed to be conduct with a Regulatory Authority for such Licensed Product, in each case ((a)-(c)) for such Licensed Product that the other Party does not desire to co-fund (each a “Supplemental Study”), the Party desiring to conduct such Supplemental Study(ies) may do so at its own cost and expense in its Territory or in the other Party’s Territory, subject to the following limitations in this Section 7.3.2. If a Party wants to conduct a Supplemental Study for a Licensed Product in the other Party’s Territory, such Supplemental Study shall require the consent of such other Party, which consent shall not be unreasonably withheld by such other Party; provided that such consent may be reasonably withheld by such other Party if such other Party determines in good faith using industry-reasonable criteria that such Supplemental Study would likely cause commercial harm to such other Party or its Affiliates or Sublicensees in such other Party’s respective Territory. At the request of the Party proposing to conduct such Supplemental Study, such other Party shall explain at the JDC the basis for its determination to withhold its consent to such Supplemental Study in such other Party’s Territory. If the Party proposing to conduct the Supplemental Study believes that it is impractical or such Party will be unable to fulfill a post-marketing commitment mandated or agreed to with a Regulatory Authority unless such Supplemental Study is conducted in the other Party’s Territory, the Party proposing to conduct such Supplemental Study shall have the burden of demonstrating that it is impractical or unable to conduct such Supplemental Study unless such Supplemental Study is conducted in the other Party’s Territory. The other Party shall have the right (but not the obligation) (the “Supplemental Study Opt-In Right”)...
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Supplemental Studies. Each member reserves the right to conduct separate or
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Supplemental Studies 
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Related to Supplemental Studies

  • 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.

  • 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.

  • 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.

  • Supplemental Information From time to time after the applicable Assignment Date with respect to each Mortgage Loan, Seller promptly shall furnish Purchaser such incidental information, which is reasonably available to Seller, supplemental to the information contained in the documents and schedules delivered pursuant to this Agreement, as may reasonably be requested to monitor performance of the Mortgage Loans and the payment of the Future Excess Servicing Spread.

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