Use and Return of Investigational Product Sample Clauses

Use and Return of Investigational Product and Materials 1.6 Použití a vrácení Hodnoceného léčiva a Materiálů Sponsor shall supply, directly or indirectly, Investigator at Institution’s facilities with sufficient amount of Investigational Product as described in the Protocol. Zadavatel zajistí, přímo nebo či nepřímo, že Zkoušející bude mít v prostorách Zdravotnického zařízení k dispozici dostatečné množství Hodnoceného léčiva, jak je popsáno v Protokolu. Institution shall not permit the use of the Investigational Product or any other Materials for any purpose other the conduct of the Study. Zdravotnické zařízení neumožní použití Hodnoceného léčiva ani jiného Materiálu za jiným účelem, než je provádění Studie. Institution will enable Investigator to maintain the Investigational Product and all other Materials as specified by Sponsor and according to Applicable Laws and regulations, including storage at all times in a locked, secured area, access to which is limited, to prevent theft or diversion. Institution shall store all Investigational Product in either a central pharmacy where a qualified pharmacist supervises dispensing, or in a restricted area and dispensed under the direct supervision of Investigator. Zdravotnické zařízení umožní Zkoušejícímu uchovávat Hodnocené léčivo a další Materiály dle pokynů Zadavatele a v souladu s Příslušnými právními předpisy, včetně povinnosti skladovat Hodnocené léčivo v uzamčeném a zabezpečeném prostoru, ke kterému je omezen přístup, aby bylo zabráněno ztrátě nebo odcizení. Zdravotnické zařízení bude uchovávat Hodnocené léčivo buďto v centrální lékárně, kde bude kvalifikovaný farmaceut dohlížet na vydávání léčiva, nebo v uzavřeném prostoru, kde bude léčivo vydáváno pod přímým dohledem Zkoušejícího. All Investigational Product and other Materials shall be the property of Sponsor, unless otherwise agreed by Sponsor in writing. Veškeré Hodnocené léčivo a další Materiály zůstanou ve vlastnictví Zadavatele, ledaže bude se Zadavatelem sjednáno písemně jinak.
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Use and Return of Investigational Product and Equipment 1.6. Použitie a vrátenie skúšaného produktu a vybavenia Sponsor or a duly authorized agent of Sponsor, shall supply Investigator at Institution’s facilities with sufficient amount of Investigational Product as described in the Protocol. Zadávateľ alebo jeho riadne splnomocnený zástupca dodá skúšajúcemu do priestorov zdravotníckeho zariadenia dostatočné množstvo skúšaného produktu, v súlade s protokolom. Institution will enable Investigator to maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a locked, secured area at all times. Zdravotnícke zariadenie zabezpečí, aby skúšajúci za každých okolností skladoval skúšaný produkt podľa pokynov zadávateľa a podľa platných právnych predpisov, vrátane skladovania v uzamknutých a zabezpečených priestoroch. If applicable, the Institution shall return any equipment or materials provided by Sponsor for use in the Study unless Sponsor and Institution have a written agreement for V relevantných prípadoch zdravotnícke zariadenie vráti všetko vybavenie a všetky materiály poskytnuté zadávateľom na použitie v skúšaní, pokiaľ zadávateľ a zdravotnícke Institution to acquire the equipment. If there are Institution’s facility improvements provided by IQVIA or Sponsor in relation to the Study, then Institution shall enter a separate written agreement with IQVIA or Sponsor with respect to such facility improvements. zariadenie neuzatvoria písomnú zmluvu o nadobudnutí vybavenia zdravotníckym zariadením. Ak zadávateľ alebo spoločnosť IQVIA poskytnú v súvislosti so skúšaním nejaké úpravy priestorov zdravotníckeho zariadenia, uzatvorí zdravotnícke zariadenie so spoločnosťou IQVIA alebo zadávateľom samostatnú zmluvu, týkajúcu sa takýchto úprav priestorov.
Sample 1
Use and Return of Investigational Product. Zadavatel bez zbytečného odkladu vyrozumí Místo výkonu klinického hodnocení, EK a IQVIA, ohledně jakéhokoli zjištění, jež je způsobilé ovlivnit bezpečenost Subjektů studie či jejich vůli a ochotu pokračovat v účasti ve Studii, mít vliv na provádění Studie, či změnit vydané souhlasné stanovisko EK vztahující se k pokračování ve Studii.
Sample 1
Use and Return of Investigational Product and Equipment 1.6. Použitie a vrátenie skúšaného produktu a vybavenia Sponsor or a duly authorized agent of Sponsor, shall supply Investigator at Institution’s facilities with sufficient amount of Investigational Product as described in the Protocol. Zadávateľ alebo jeho riadne splnomocnený zástupca dodá skúšajúcemu do priestorov zdravotníckeho zariadenia dostatočné množstvo skúšaného produktu, v súlade s protokolom. Institution will enable Investigator to maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a locked, secured area at all times and will not administer or dispense it to anyone who is not a Study subject, or provide access to it to anyone except Investigator, Subinvestigators, or Study Staff. Zdravotnícke zariadenie zabezpečí, aby skúšajúci za každých okolností skladoval skúšaný produkt podľa pokynov zadávateľa a podľa platných právnych predpisov, vrátane skladovania v uzamknutých a zabezpečených priestoroch. a nepodá ho ani nevydá nikomu, kto nie je účastníkom skúšania, ani neposkytne prístup k nemu nikomu okrem skúšajúceho, spoluskúšajúcich alebo personálu skúšania If applicable, the Institution shall return any equipment or materials provided by Sponsor for use in the Study unless Sponsor and Institution have a written agreement for Institution to acquire the equipment. If there are Institution’s facility improvements provided by IQVIA or Sponsor in relation to the Study, V relevantných prípadoch zdravotnícke zariadenie vráti všetko vybavenie a všetky materiály poskytnuté zadávateľom na použitie v skúšaní, pokiaľ zadávateľ a zdravotnícke zariadenie neuzatvoria písomnú zmluvu o nadobudnutí vybavenia zdravotníckym zariadením. Ak zadávateľ alebo spoločnosť Slovakia PI: Xxxxxxxx Xxxxx, MD, PhD, FEBOClinical Trial Agreement template-INST_ based on IQVIA Global template – 1 May 2019 XXXXXXX Xxxxxx 0 z 31
Sample 1
Use and Return of Investigational Product. GSK bez zbytečného odkladu vyrozumí Místo výkonu klinického hodnocení, LEK a IQVIA, ohledně jakéhokoli zjištění, jež je způsobilé ovlivnit bezpečenost účastníků či jejich vůli a ochotu pokračovat v účasti ve Studii, mít vliv na provádění Studie, či změnit vydané souhlasné stanovisko LEK Místa provádění klinického hodnocení vztahující se k pokračování ve Studii.
Sample 1

Related to Use and Return of Investigational Product

  • Facilitation of Investigation In case of any allegation of violation of any provisions of this Pact or payment of commission, the BUYER or its agencies shall be entitled to examine all the documents including the Books of Accounts of the BIDDER and the BIDDER shall provide necessary information and documents in English and shall extend all possible help for the purpose of such examination.

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Tax and Regulatory Matters No Buyer Entity or, to the Knowledge of Buyer, any Affiliate thereof has taken or agreed to take any action, and Buyer does not have any Knowledge of any agreement, plan or other circumstance, that is reasonably likely to (i) prevent the Merger from qualifying as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code, or (ii) materially impede or delay receipt of any of the Requisite Regulatory Approvals.

  • Regulatory Matters (a) Except as expressly set forth in Section 8.10 or the Transition Services Agreement, from and after the Closing, Purchaser, at its cost, shall be solely responsible and liable for (i) taking all actions, paying all fees and conducting all communication with the appropriate Governmental Authority required by Applicable Law in respect of the Regulatory Approvals, including preparing and filing all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority (whether the Product is sold before or after transfer of such Regulatory Approval), (ii) taking all actions and conducting all communication with third parties in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including responding to all complaints in respect thereof, including complaints related to tampering or contamination, and (iii) investigating all complaints and adverse drug experiences in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval). (b) From and after the Closing, and subject to Section 8.10 hereof and the Transition Services Agreement, Seller promptly (and in any event within the time periods required by Applicable Law) shall notify Purchaser within three (3) Business Days if Seller receives a complaint or a report of an adverse drug experience in respect of the Product. In addition, Seller shall cooperate with Purchaser’s reasonable requests and use commercially reasonable efforts to assist Purchaser in connection with the investigation of and response to any complaint or adverse drug experience related to the Product sold by Seller. (c) From and after the Closing, Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Inventory, and reasonable credits extended to customers in connection with the recall. Seller shall notify Purchaser promptly in the event that a recall of the Product sold by Seller is necessary. (d) Seller shall, within fifteen (15) days after the Closing, notify the FDA of the transfer of the Regulatory Approvals to Purchaser in accordance with all Applicable Laws.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company 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 (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical 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.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Accounting, Tax and Regulatory Matters Each Owner and the Company, -------------------------------------- jointly and severally, represents and warrants to Premiere that neither the Company, any Owner nor any Affiliate thereof has taken or agreed to take any action or has any knowledge of any fact or circumstance that is reasonably likely to (i) prevent the Merger from qualifying for pooling-of-interests accounting treatment or as a reorganization within the meaning of Section 368(a) of the Code, or (ii) materially impede or delay receipt of any consents referred to in Section 5.6 of the Uniform Terms or result in the imposition of a condition or restriction of the type referred to in the last sentence of such Section.

  • Corporate Examinations and Investigations Prior to the Closing Date, the parties acknowledge that they have been entitled, through their employees and representatives, to make such investigation of the assets, properties, business and operations, books, records and financial condition of the other as they each may reasonably require. No investigations, by a party hereto shall, however, diminish or waive any of the representations, warranties, covenants or agreements of the party under this Agreement.

  • Tax and Accounting Treatment Each party to this Agreement acknowledges that it is its intent for purposes of U.S. federal, state and local income and franchise taxes, and for accounting purposes, to treat each Transaction as indebtedness of Seller that is secured by the Purchased Mortgage Loans and that the Purchased Mortgage Loans are owned by Seller in the absence of a Default by Seller. All parties to this Agreement agree to such treatment and agree to take no action inconsistent with this treatment, unless required by applicable Requirements of Law or GAAP.

  • Environmental Studies Promptly conduct and complete, at Borrower’s expense, all such investigations, studies, samplings and testings as may be requested by Lender or any governmental authority relative to any substance, or any waste or by-product of any substance defined as toxic or a hazardous substance under applicable federal, state, or local law, rule, regulation, order or directive, at or affecting any property or any facility owned, leased or used by Borrower.

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