Supply of Investigational Drug Sample Clauses

Supply of Investigational Drug. The Sponsor shall ensure the distribution of shipments of the Investigational Drug and placebo to the Institution’s pharmacy, where it shall be accepted and inspected by the delegated pharmacist (using the same procedure as for other shipments – i.e. check that no damage is present, in case of special transportation requirements, check that these requirements have been complied with, and confirm acceptance of the shipment). Subsequently, based on a request form, the Principal Investigator shall collect the Investigational Drug and shall assume full responsibility for it. The Sponsor shall be obliged to provide a notification at least 3 working days prior to the delivery when the shipment will be delivered to the pharmacy, either by email via IVRS to the address The Institution shall notify Sponsor of unused drugs in need of disposal or collection and shall cooperate with Sponsor 3.2 Dodávání hodnoceného léčiva. Zadavatel zajistí distribuci zásilky hodnoceného léčiva a placeba do lékárny zdravotnického zařízení, kde je odpovědný farmaceut převezme a zkontroluje (jako jiné zásilky - tzn., není-li poškozena, v případě zvláštních požadavků na transport, byly-li tyto požadavky dodrženy, příjem zásilky potvrdí), následně si na žádanku hlavní zkoušející hodnocené léčivo vyzvedne a je za ně plně zodpovědný. Zadavatel je povinen oznámit do 3 pracovních dnů před dodáním, kdy bude zásilka do lékárny předána buďto přes IVRS, emailem na . Zdravotnické zařízení bude Zadavatele informovat o nevyužitých lécích, které bude třeba zlikvidovat nebo shromáždit, a bude se Zadavatelem při této likvidaci či sběru spolupracovat. Likvidaci či sběr nevyužitých léků si zadavatel zajistí na vlastní náklady. in such disposal or collection. Sponsor shall arrange for the disposal or collection of unused drugs at Sponsor’s cost. The Sponsor undertakes to provide the Investigational Drug and placebo in the amount and time intervals needed for the proper conduct of the Study. The Sponsor declares that all the conditions stipulated in the relevant legislation have been met for manufacture (import) of delivered investigational products and their distribution to the Institution. The Sponsor, as the source of waste, undertakes to ensure at Sponsor’s own costs, both during and after the clinical trial, the transfer of unusable and unused medicinal product to an authorized person in accordance with the provisions of the Act No. 185/2001 Coll., on waste and its implementing regulations, as amended...
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Supply of Investigational Drug. The Sponsor and/or its Affiliate shall supply the Institution/Principal Investigator with quantities of the Investigational Drug adequate for the Institution/Principal Investigator to conduct the Study in accordance with the Protocol. The Investigational Drug shall remain the sole property of the Sponsor and/or its Affiliate. The Institution/Principal Investigator shall take reasonable steps to ensure that it has adequate supplies of the Investigational Drug, shall store, use, handle, and return or dispose of the Investigational Drug in accordance with the Protocol, and shall not use any Investigational Drug after its labeled expiration date. 3.2
Supply of Investigational Drug. The Sponsor and/or its Affiliate shall supply the Institution/Principal Investigator with quantities of the Investigational Drug adequate for the Institution/Principal Investigator to conduct the Study in accordance with the Protocol. The Investigational Drug shall remain the sole property of the Sponsor and/or its Affiliate. The Institution/Principal Investigator shall take reasonable steps to ensure that it has adequate supplies of the Investigational Drug, shall store, use, handle, and return or dispose of the Investigational Drug in accordance with the Protocol, and shall not use any Investigational Drug after its labeled expiration date. 3.2 Dodávání hodnoceného léčiva. Zadavatel a/nebo jeho sesterská společnost bude zdravotnickému zařízení/hlavnímu zkoušejícímu dodávat taková množství hodnoceného léčiva, která jsou adekvátní k tomu, aby zdravotnické zařízení/hlavní zkoušející mohli provádět studii v souladu s protokolem. Hodnocené léčivo zůstává výhradním vlastnictvím zadavatele a/nebo jeho sesterské společnosti. Zdravotnické zařízení / hlavní zkoušející podniknou přiměřené kroky, aby zajistili, že budou mít k dispozici adekvátní zásoby hodnoceného léčiva, a xxxx budou hodnocené léčivo uchovávat, používat, zacházet s ním a xxxxxx xx xxxx xx likvidovat v souladu s protokolem, a žádné hodnocené léčivo nepoužijí po uplynutí vyznačené expirační xxxx.

Related to Supply of Investigational Drug

  • 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.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum.

  • Complaints Investigation ‌ An employee who complains of harassment under the provisions of the Human Rights Code of British Columbia may refer the complaint to either one or other of the following processes:

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. Clinical Trials This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

  • Formal Investigation Once the matter has been brought to the attention of the Store executive, an internal investigation of the complaint will be conducted at which time the complainant will be requested to present, in writing, the particulars of the harassment. Such internal investigation will be initiated no later than ten (10) business days of the matter being brought to the attention of the Store executive, and shall be concluded no later than thirty (30) business days of the initiation of the investigation. Any extension of the aforementioned time frames must have the agreement of the complainant and the union if the complainant has chosen to involve it. Based on the outcome of the investigation, which will be provided in writing upon the completion of the investigation, to both the complainant and the union, should the complainant consent to this disclosure, it will be determined if there has been a breach of Company policy on harassment, and the appropriate action will be taken in the event that harassment is determined to have occurred. STEP THREE - SUBSEQUENT INCIDENTS Subsequent incidents should immediately be reported and followed by a written description to the most senior store executive involved in Step Two for further investigation and disciplinary action, if confirmed, with a copy to the union Chairperson with the consent of the complainant. After all steps of the Harassment Protection Policy have been exhausted, if the incident has not been resolved to the satisfaction of the employee, the employee may file a grievance at Step 2 of the grievance procedure.

  • Grievance Investigation The Employer agrees to supply to the Union the names of all applicants for a vacancy, or new position in the course of a grievance investigation.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

  • Compliance Investigations Upon City’s request, Contractor agrees to provide to City, within sixty calendar days, a truthful and complete list of the names of all subcontractors, vendors, and suppliers that Contractor has used in the past five years on any of its contracts that were undertaken within San Diego County, including the total dollar amount paid by Contractor for each subcontract or supply contract. Contractor further agrees to fully cooperate in any investigation conducted by City pursuant to City's Nondiscrimination in Contracting Ordinance. Contractor understands and agrees that violation of this clause shall be considered a material breach of the Contract and may result in Contract termination, debarment, and other sanctions.

  • Suspension Pending Investigation When, in the judgment of the President, the presence of a Faculty Member on University property presents a threat to the health or safety of the Faculty Member or anyone in the University community or represents a threat of substantial disruption or substantial interference with the normal and lawful activities of the University community, the President may suspend with pay the Faculty Member pending the disposition of the disciplinary process provided in this Agreement. The President may also direct that the Faculty Member be removed and barred from University property. Such suspensions shall not be invoked in an arbitrary or capricious manner, and shall end upon the conclusion of the Article 9 investigation or, if discipline is proposed, at the end of any subsequent grievance proceeding.

  • Criminal Background Investigations For investigative Vendor Staff, Citizens will accept a copy of a current Class C Private Investigator license as proof that a criminal background check has been conducted for that investigator. For all other Vendor Staff, Vendor must provide Citizens with a copy of a criminal background check performed on such Vendor Staff dated within thirty (30) days of submission of the Vendor Staff to Citizens for qualification and credentialing review. Vendor shall use Exhibit D, Applicant Background Review Guide to as a guideline to determine eligibility of Vendor Staff to perform Services. The criminal background check must be updated every two (2) years thereafter. All background checks will be at Vendor’s expense and, unless otherwise approved in writing by Citizens’ Contract Manager, shall include but not be limited to: (a) state and federal felony convictions or pending adjudications; (b) state and federal misdemeanor convictions or pending adjudications; (c) any crimes in violation of the Violent Crime Control and Law Enforcement Act of 1995 or pending adjudications; and, (d) a seven (7) year minimum timeframe, extending as close as practicable to the date of Assignment to perform Services. Vendor will advise Citizens’ Contract Manager or designee if it knows of any Vendor Staff that has a criminal conviction (misdemeanor or felony), regardless of adjudication (adjudication withheld, a plea of guilty or nolo contendere, or a guilty verdict), within the last ten (10) years in any jurisdiction. Vendor shall not allow that individual to act as a Vendor Staff until Vendor determines whether that individual should be allowed to do so considering (a) the nature and gravity of the offense; (b) the amount of time that lapsed since the offense;

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