Charging Study Subjects Sample Clauses

Charging Study Subjects. Neither Principal Investigator nor Institution will charge a Study Subject or third-party payer for Investigational Drug (see Section 8, Investigational Drug) or for any services reimbursed by CRO under this Agreement.
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Charging Study Subjects. Institution will not charge a Study Subject or third-party payer for Investigational Drug (see Section 8, Investigational Drug) or for any services reimbursed by CRO under this Agreement or the agreement between CRO and Principal Investigator. 5.1 Účtování poplatků subjektům klinického hodnocení. Zdravotnické zařízení nebude za hodnocený lék (viz xxxxxx 0, Xxxxxxxxx xxx) ani za jiné služby, které hradí CRO podle této smlouvy nebo podle smlouvy mezi CRO a hlavním zkoušejícím, nic účtovat subjektům klinického hodnocení ani plátcům třetí strany.
Charging Study Subjects. The Health Services Provider will not charge a Study Subject or third-party payer for Investigational Drug (see Section 8, Investigational Drug) or for any services reimbursed by CRO under this Agreement or the agreement between CRO and Principal Investigator.
Charging Study Subjects. Institution will not charge a Study Subject or third party payer for Investigational Drug (see Section 9, Investigational Drug) or for any services reimbursed by Pfizer under the Study Order.
Charging Study Subjects. Institution and Principal Investigator will not charge a Study Subject or third-party payer for any services reimbursed by CRO under this Agreement. 5.2
Charging Study Subjects. Institution will not charge a Study Subject or third-party payer for Investigational Drug (see Section 8, Investigational Drug) or for any services reimbursed by CRO under this Agreement or the agreement between CRO and Principal Investigator. 5.1 Účtování poplatků Subjektům Studie. Instituce nebude účtovat Subjektům Studie ani třetím plátcům hodnocené léčivo (viz článek 8, Hodnocené léčivo) ani jiné služby, které hradí CRO podle této Smlouvy nebo podle Smlouvy mezi CRO a Hlavním zkoušejícím. 5.2 Safety Measures and Serious Protocol or ICH GCP Breaches. Institution will inform CRO immediately (directly or through Principal Investigator) of (a) any urgent safety measures taken by Principal Investigator to protect Study Subjects against immediate hazard and (b) 5.2 Bezpečnostní opatření a závažná porušení pravidel Protokolu nebo pokynů ICH GCP. Instituce se zavazuje neprodleně informovat CRO (přímo či prostřednictvím hlavního zkoušejícího) (a) v případě jakéhokoli urgentního bezpečnostního opatření, které Hlavní zkoušející použije v zájmu ochrany Subjektů Studie proti any serious breaches of the Protocol or of ICH GCP guidelines of which Institution becomes aware. okamžitému riziku a (b) v případě jakéhokoli závažného porušení Protokolu nebo pokynů ICH GCP, o kterých se Instituce dozví. 5.3
Charging Study Subjects. 5.1 Účtování poplatků Subjektům Institution will not charge a Study Studie. Instituce nebude účtovat Subject or third-party payer for Subjektům Studie ani třetím Investigational Drug (see plátcům hodnocené léčivo (viz Section 8, Investigational Drug) or článek 8, Hodnocené léčivo) ani for any services reimbursed by jiné služby, které hradí CRO podle CRO under this Agreement or the této Smlouvy nebo podle Smlouvy agreement between CRO and mezi CRO a Hlavním Principal Investigator. zkoušejícím.
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Charging Study Subjects. The Health Services Provider will not charge a Study Subject or third-party payer for Investigational Medicinal Products (see Xxxxxxx 0, Xxxxxxxxxxxxxxx Xxxx) or for any services reimbursed by CRO under this Agreement or the agreement between CRO and Principal Investigator. Účtování poplatků Subjektům Studie. Poskytovatel zdravotních služeb nebude účtovat Subjektům Studie ani třetím plátcům hodnocené léčivé přípravky (viz článek 8, Hodnocené léčivo) ani jiné služby, které hradí CRO podle této Smlouvy nebo podle Smlouvy mezi CRO a Hlavním zkoušejícím.

Related to Charging Study Subjects

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • 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.

  • 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.

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

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Development Costs With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as of such date; (ii) all payments owing by Alimera hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), and further including any penalties and interest which might have accrued with respect thereto; and (iii) subject to Sections 3.1.1 and 3.1.2, from and after the Amendment Effective Date, CDS will have no liability whatsoever hereunder for any past, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date), and instead Alimera shall have sole liability therefor.

  • 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.

  • 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.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

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