Performance of the Clinical Sample Clauses

Performance of the Clinical. Trial 1.1 The parties agree that the Protocol, including any subsequent Protocol amendments, if not attached hereto but known to all parties, and the Exhibits form an integral part of this Agreement. 1.2 Institution and Principal Investigator agree to use their best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, the identified timelines and the terms and conditions of this Agreement. Institution and Principal Investigator may not start the clinical trial without prior approval of the ethics committee, notifications and further legally required approvals. 1.3 In the event that the Principal Investigator becomes no longer affiliated with Institution, Institution shall provide written notice to Sponsor and CRO as soon as possible and at the latest within three (3) calendar days of such departure. Sponsor or CRO on behalf of the Sponsor shall have the right to approve any new Principal Investigator designated by Institution. The new Principal Investigator shall be required to agree to the terms and conditions of this Agreement. In the event Sponsor does not approve such new Principal Investigator, Sponsor may terminate this Agreement in accordance with Section 2.2 below and Institution shall take all necessary steps to accommodate Sponsor’s decision. If Principal Investigator is to be temporarily absent from Institution for more than 10 days, but not more than 14 days, Institution will designate a Sub-investigator to temporarily supervise the Study on the Principal Investigator’s behalf. Institution will document this designation and notify Sponsor in writing of such designation prior to its commencement. If Principal Investigator is, or is to be, absent for more than 14 days, Sponsor may terminate Agreement if Institution and Sponsor cannot agree on a replacement Principal Investigator within a 14-day period. 1.4 Institution and Principal Investigator may appoint such other individuals and investigational staff as they may deem appropriate as co-investigator or investigational staff to assist in the conduct of the Clinical Trial. All co-investigators and investigational staff will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of co-investigators and investigational staff, who in all respect shall be bound to the same terms and conditions as the Principal Inves...
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Performance of the Clinical. Trial 1.1 The parties agree that the Protocol, including any subsequent Protocol amendments, if not attached hereto but known to all parties, and the Exhibits form an integral part of this Agreement. 1.2 Institution and Principal Investigator agree to use their best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements,
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Performance of the Clinical. Trial 1.1 The parties agree that the Protocol, including any subsequent Protocol amendments, if not attached hereto but known to all parties, and the Exhibits form an integral part of this Agreement. 1.2 Institution and Principal Investigator agree to use their best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, the identified timelines and the terms and conditions of this Agreement. Institution and Principal Investigator may not start the clinical trial without prior approval of the ethics committee, notifications and further legally required approvals. 1.3 In the event that the Principal Investigator becomes no longer affiliated with Institution, Institution shall provide written notice to Sponsor and CRO as soon as Zdravotnické zařízení bere na vědomí, že ZADAVATEL spolu s touto smlouvou podepíše současně také smlouvu s hlavním zkoušejícím ohledně činností, které má hlavní zkoušející během klinického hodnocení vykonávat a které jdou nad rámec činností, za které je na základě této smlouvy, odpovědné zdravotnické zařízení. V této smlouvě s hlavním zkoušejícím bude specifikována odměna pro hlavního zkoušejícího a členy týmu, provádějícího klinické hodnocení, za provádění těchto činností. Zdravotnické zařízení bere na vědomí a souhlasí s xxx, že odměna za služby poskytované pro účely klinického hodnocení hlavním zkoušejícím a členy týmu provádějícího klinické hodnocení na základě těchto samostatných smluv, může být vyplacena přímo hlavnímu zkoušejícímu a členům týmu provádějícího klinické hodnocení. Se nyní proto, s ohledem na výše uvedené skutečnosti a vzájemné sliby a ujednání vyjádřené v této Smlouvě, Strany dohodly následovně: 1. Provedení Klinického hodnocení 1.1 Strany souhlasí, že Protokol, včetně veškerých následných dodatků k Protokolu, pokud nejsou k této Smlouvě přiloženy, ale jsou všem stranám známy, jakož i přílohy této Smlouvy tvoří její nedílnou součást. 1.2 Zdravotnické zařízení a Hlavní zkoušející souhlasí, že vyvinou maximální úsilí a využijí odbornou způsobilost při provádění Klinického hodnocení v souladu s Protokolem, všemi platnými právními a regulačními požadavky, určenými časovými harmonogramy a podmínkami této Smlouvy. Zdravotnické zařízení a Hlavní zkoušející nesmí zahájit Klinické hodnocení bez předchozího souhlasu etické komise, oznámení a dalších souhlasů nutných dle právních předpisů. 1.3 V případě, že Hlavní zkoušející již nebu...
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Performance of the Clinical. Trial 1.1 Institution and Principal Investigator agrees to use best efforts and professional expertise to perform the Clinical Trial in accordance with the Protocol, all applicable legal and regulatory requirements, such as regulation No 140/1998 subsequently amended, regulation No. 428/2002 subsequently amended, regulation No.576/2004 subsequently amended, approved by State Institute for Drug Control No. 2010/1914/SBLKS on 24.3.2011, approved by Ethic Commitee No. EK/10/37 on 9.12.2010 and with the identified timelines and the terms and conditions of this Agreement. 1.2 Institution may appoint such other individuals and investigational staff as it may deem appropriate as co-investigator and investigational staff to assist in the conduct of the Clinical Trial. All co-investigators and investigational staff will be adequately qualified, timely appointed and an updated list will be maintained. Names of co-investigators: MUDr.Milena Surová, MUDr.Monika
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Related to Performance of the Clinical

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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).

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