Additional Clinical Trials Sample Clauses

Additional Clinical Trials. 7.1 The Licensee may from time to time, propose to the Licensor that additional Clinical Studies be initiated in relation to the Product in the Territory whether on its own initiative or because a Phase IV Clinical Trial is required by FDA (“Additional Studies”). The Parties shall meet and discuss the same in good faith and if the Parties agree the plans and protocols for such Additional Studies the Licensee may at its sole cost and expense proceed with the additional Clinical Study which shall be included as part of the Lifecycle Management Plan. Provided that where any Phase IV Clinical Trial is required by the FDA in the Territory after the NDA Approval Date, the Parties shall promptly agree in good faith the plans and protocols for such Additional Study and the Licensee shall be entitled to conduct the same as a Clinical Study, at its sole cost and expense.
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Additional Clinical Trials. Subject to the terms of this Section 4.10, during the Option Period, OV will have the right to propose amendments to the Clinical Development Plan to include additional clinical trials using the Product and the DRP Biomarker for the treatment of patients with mBC. If OV desires to conduct any such additional clinical trial, it will notify the JDC in writing, and discuss such additional clinical trial with R-Pharm at the JDC and provide the JDC any information reasonably requested by the JDC related to such additional clinical trial. The JDC will consider in good faith any such proposal for an additional clinical trial, and if, and only if, the JDC approves to amend the Clinical Development Plan to include such additional clinical trial, OV may thereafter conduct such additional clinical trial (but subject to the terms and conditions imposed by the JDC as part of the JDC’s approval of the additional clinical trial). In all cases, OV shall keep the JDC updated with respect to all such additional clinical trials (including the results generated therefrom) at each meeting of the JDC, and shall provide to R-Pharm such other information with respect to any such additional clinical trial as reasonably requested by R-Pharm.
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Additional Clinical Trials. If, following the completion of the Pre-Funded Activities for an Initial Licensed Program, the JDC or any Regulatory Authority determines that it is necessary, in order to obtain Regulatory Approval of an Initial Licensed Product under such Initial Licensed Program, to re-perform or conduct any additional Clinical Trial prior to a Pivotal Trial with respect to such Initial Licensed Product (each, an “Additional Clinical Trial”), then the Development Budget for such Initial Licensed Product shall be modified to include the Development Costs of the Additional Clinical Trial and, if AGTC has exercised the Milestone/Royalty Option with respect to such Initial Licensed Program, AGTC shall share such Development Costs equally with Biogen unless, in such event, AGTC notifies Biogen prior to any such Development Costs being incurred that it elects to not share such Development Costs equally, in which case, AGTC shall not be required to share any such Development Costs with Biogen, and such election shall have the effect described in the final paragraph of Section 6.4.1. For clarity, if AGTC has exercised the Cost Share Option with respect to such Initial Licensed Program, the Parties shall share any Development Costs under this Section 3.2.2(c) in accordance with the provisions of Section 6.3. CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. TRIPLE ASTERISKS [***] DENOTE OMISSIONS. 28
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Additional Clinical Trials. (a) For a period of ** from the date of the Agreement, the Parties agree that they will cooperate in good faith to provide Recipient with the opportunity to be a primary clinical site in any Additional Clinical Trial sponsored by Corautus, subject to applicable law and reasonable qualifications. Corautus shall permit Recipient to state in its marketing and similar materials that Recipient is Corautus’ premier clinical site in such Additional Clinical Trials if Recipient is actively participating in such Additional Clinical Trial as an investigator. Notwithstanding the foregoing, because the details, timing and conditions of any Additional Clinical Trial cannot be predicted, Corautus shall not be obligated to Recipient as a clinical site for, and Recipient shall not be obligated to participate as a clinical site in any Additional Clinical Trial.
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Additional Clinical Trials. In the event that any European Union regulatory authority requires two (2) clinical trials for Approval in three (3) or more of the Major European Markets, then the Parties shall meet and negotiate in good faith a revised timeline for the Type II Variation filings, including a revised timeframe for the Second Milestone Payment set forth in Section 5.5.
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Additional Clinical Trials. On a Clinical Trial-by-Clinical Trial basis, prior to conducting a Clinical Trial for an Additional Indication, Licensor will provide Pfizer, through the JDMRC, with the clinical study protocol for such Clinical Trial reasonably in advance of the start of such Clinical Trial in order for Licensor to consult with Pfizer and for Pfizer to review and provide comments on such clinical trial protocol. Licensor will in good faith consider any reasonable suggestions by Pfizer with respect to such Clinical Trial, but, subject to Section 3.8.2(b) (Licensor Final Decision-Making Authority), will have the right to conduct such Clinical Trial in its sole discretion and at its sole cost.
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Additional Clinical Trials. The Steering Committee shall determine whether to allow any Investigator Sponsored Trials or conduct any Phase II Clinical Trials, Phase III Clinical Trials, or Phase IV Studies of Prochymal for the GvHD Indication, Major Indications and Other Indications in addition to the Osiris Funded Trials (each an “Additional Clinical Trial”) that have not been initiated prior to the Effective Date; provided that in the event Genzyme makes a Prochymal Development Milestone Payment for the achievement of Statistical Significance for Prochymal for a particular Indication, then any Phase III Clinical Trial and Phase IV Study reasonably required to obtain Marketing Approval for Prochymal for such Indication shall be conducted by Osiris; and provided further that if the Steering Committee has determined to initiate any Additional Clinical Trial (other than an Investigator Sponsored Trial), such trial shall be conducted by Osiris and shall be subject to agreement by the Steering Committee on the clinical strategy and protocol design. Nothing in this Section 3.1.3 shall prohibit a Party from pursuing an At-Risk Indication. All Commercial Post-Marketing Studies will be one hundred percent (100%) funded by the Party conducting such Studies.
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Additional Clinical Trials. SPA, at its sole discretion, may conduct clinical trials of Unoprostone and/or Licensed Product in SPA Territory, at its sole expense.
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Related to Additional Clinical Trials

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • 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.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Trials The Ship shall run the following test and trials:

  • 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.

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