Clinical Supplies Sample Clauses
The Clinical Supplies clause outlines the responsibilities and procedures related to the provision, management, and use of materials required for a clinical trial, such as investigational drugs, placebos, or medical devices. It typically specifies which party is responsible for supplying these materials, how they should be stored, labeled, and tracked, and may address issues like shipment, handling, and return or destruction of unused supplies. This clause ensures that all clinical materials are managed in compliance with regulatory standards and study protocols, thereby safeguarding participant safety and maintaining the integrity of the trial.
POPULAR SAMPLE Copied 1 times
Clinical Supplies. As applicable for the Protocol, Sponsor shall make available sufficient quantities of Study Drug free of charge to carry out the Study, it being understood that Institution and Principal Investigator shall take responsibility for and reasonable steps to maintain appropriate records and assure appropriate takeover, handling, storage, distribution and usage of the Study Drug and any other Sponsor provided materials, including but not limited to equipment, in accordance with the Protocol and any applicable laws and regulations relating thereto. Institution and Principal Investigator will not use for any other purpose or conduct any other research activities with the Study Drug provided under this Agreement or the materials provided under this Agreement than that stated in the Protocol. All unused Study Drug and Sponsor provided materials will be returned to Sponsor by Institution or Principal Investigator at the conclusion of the Study, or upon earlier termination of this Agreement, unless written authorization to destroy or retain Smlouva je povinně uveřejňovaným dokumentem podle zákona č. 340/2015 Sb. (zákon o registru smluv). Strany se dohodly, že uveřejnění této Smlouvy prostřednictvím registru smluv podle § 5 odst. 1 citovaného zákona bude provedeno Zdravotnickým zařízením bez zbytečného odkladu, nejpozději však do 20 dnů od jejího uzavření. Zadavatel doručí Zdravotnickému zařízení bez zbytečného odkladu konečnou ▇▇▇▇▇ dokumentů (se znečitelněnými částmi), které jsou předmětem uveřejnění. Zadavatel ani Hlavní zkoušející nejsou oprávněni k uveřejnění této Smlouvy, ledaže Zdravotnické zařízení tak ve stanovené lhůtě (jak je uvedena výše) neučiní. V takovém případě převezme Zadavatel odpovědnost za uveřejnění. Strany jsou srozuměny s ▇▇▇, že informace tvořící obchodní tajemství Stran a další informace, které nepodléhají povinnosti uveřejnění, budou před odesláním Smlouvy k uveřejnění znečitelněny. S ohledem na uvedené Strany souhlasí s ▇▇▇, že Zadavatel před uveřejněním zajistí ochranu osobních údajů (včetně jména a příjmení, jakéhokoliv typu identifikačních údajů, dat narození, adres bydliště, telefonních čísel, bankovních účtů apod.) jakékoli fyzické osoby zmíněné ve Smlouvě v souladu s právními předpisy na ochranu osobních údajů a znečitelní zejména počet Subjektů hodnocení zařazených do Studie, plánovaná data zahájení a ukončení Studie uvedená ve Smlouvě, jakož i jakoukoliv důvěrnou informaci Zadavatele anebo vztahující se ke Studii obsaženou v Protokol...
Clinical Supplies. As applicable for the Protocol, Sponsor shall make available sufficient quantities of Study Drug free of charge to carry out the Study. The Study Drug shall be supplied to the Provider´s of Medical Services pharmacy. Provider of Medical Services and Principal Investigator shall take responsibility for and reasonable steps to maintain appropriate records and assure appropriate supply, handling, storage, distribution and usage of the Study Drug and any other Sponsor provided materials, including but not limited to equipment, in accordance with the Protocol and any applicable laws and regulations relating thereto. Provider of Medical Services and Principal Investigator will not use for any other purpose or conduct any other research activities with the Study Drug provided under this Agreement or the materials provided under this Agreement than that stated in the Protocol. All unused Study Drug and Sponsor provided materials will be returned to Sponsor by Provider of Medical Services or Principal Investigator at the conclusion of the Study, or upon earlier termination of this Agreement, unless written authorization to destroy or retain them is given by Sponsor. If authorization to destroy unused Study Drug or Sponsor provided material is given, Provider of Medical Services or Principal Investigator shall provide Sponsor with documentation of the method of destruction. Sponsor shall own all right, title and interest in any and all material purchased or provided at the expense of Sponsor under this Agreement. Provider of Medical Services and/or Principal Investigator shall secure that the disposing of the Study Drug is in full compliance with the applicable legal regulations and guidelines of good pharmacy practice as laid down in Decree No. 84/2008 Coll. For this purpose Provider of Medical Services and/or Principal Investigator shall secure an appropriately qualified pharmacist/pharmacist who works under the employment of the Provider of Medical Services, and nepodléhají povinnosti uveřejnění, budou před odesláním Smlouvy k uveřejnění znečitelněny. S ohledem na uvedené Strany souhlasí s ▇▇▇, že Zadavatel před uveřejněním zajistí ochranu osobních údajů (včetně jména a příjmení, jakéhokoliv typu identifikačních údajů, dat narození, adres bydliště, telefonních čísel, bankovních účtů apod.) jakékoli fyzické osoby zmíněné ve Smlouvě v souladu s právními předpisy na ochranu osobních údajů a znečitelní zejména počet Subjektů hodnocení zařazených do Studie, plánovaná ...
Clinical Supplies. Unity shall be entitled to order quantities of Clinical Materials and Licensed Compound for use in clinical trials and for development purposes (e.g., stability studies and other analytical purposes) in accordance with the terms of this Section 1.2.
Clinical Supplies. Subject to the terms of this Agreement, Isconova shall manufacture and supply to Genocea all Licensed Adjuvants required for the Manufacture of Clinical Supplies necessary for Clinical Trials and all other Development activities, including pre-clinical research. The terms of supply of Clinical Supplies pursuant to this Section are set forth in Exhibit C-2.
Clinical Supplies. As applicable for the Protocol, Sponsor shall make available sufficient quantities of Study Drug free of charge to carry out the Study. The Study Drug shall be supplied into the Institution's pharmacy. It being understood that Institution and Principal Investigator shall take responsibility for and reasonable steps to maintain appropriate records and assure appropriate supply, handling, storage, distribution and usage of the Study Drug and any other Sponsor provided materials, including but not limited to equipment, in accordance with the Protocol and any applicable laws and regulations relating thereto. Institution and Principal Investigator will not use for any other purpose or conduct any other research activities with the Study Drug provided under this Agreement or the materials provided under this Agreement than that stated in the Protocol. All unused Study Drug and Sponsor provided materials will be returned to Sponsor by Institution or Principal Investigator at the conclusion of the Study, or upon earlier termination of this Agreement, unless written authorization to destroy or retain them is given by ▇▇▇▇▇▇▇. If authorization to destroy unused Study Drug or Sponsor provided material is given, Institution or Principal Investigator shall provide Sponsor with documentation of the method of destruction. Sponsor shall own all right, title and interest in any and all material purchased or provided at the expense of Sponsor under this Agreement. Institution and/or Principal Investigator shall secure that the disposing of the Study Drug is in full compliance with the applicable legal regulations and guidelines of good pharmacy practice as laid down in Decree No. 84/2008 Coll. The Institution shall secure an appropriately qualified pharmacist/pharmacy assistant who works under the employment of the Institution. The Pharmacist shall be in charge of the receipt, storage, and preparation and dispense of the study medication in accordance with the applicable laws and regulations, especially in accordance with Section 19, paragraph 1, letter d) of Decree No. 226/2008 Coll. and as per the providing documentation LEK-12 of the State Institute of Drug Control. Institution and/or Principal Investigator shall provide Sponsor with at least the name and contact details of the pharmacist/pharmacist assistant, no later than 15 days before the commencement of the Study at the Institution. Sponsor may use the provided information only for the purpose of the Study.
Clinical Supplies. Notwithstanding any provision in this Agreement to the contrary, Chiron shall have no obligation to pay any royalty to Cubist for any Licensed Products distributed by Chiron for use in any clinical study conducted by Chiron under this Agreement, including without limitation, Territory Specific Studies, clinical studies for Proposed Indications and Medical Affairs Studies. * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION
Clinical Supplies. Syntex shall manufacture for Unimed approximately 500 bottles of 100 tablets each of the Product for use by Unimed in the Studies. Such Product shall be delivered to Unimed in accordance with the timing schedule set forth in Appendix C. Syntex will mark ▇▇▇ score such Product in accordance with written instructions from Unimed.
Clinical Supplies. For clinical supplies, Teva shall deliver to Alexza a Purchase Order for the required quantities of the Product. The Parties will mutually agree on a delivery date of clinical supplies, which will depend on the special requirements (e.g., dose strength, labeling, and packaging) and Teva’s demand priority with respect to then-existing Teva orders under this Section 6.14.
Clinical Supplies. 4.1 Unless otherwise specified in a Project Exhibit to this Agreement, Corcept will supply the clinical investigators with Study Drugs and other clinical drug supplies as are agreed upon by Scirex and Corcept for the timely completion of the Projects, and will direct the shipment of any such supplies to the location indicated by Scirex, within a reasonable time after receipt of notification from Scirex of the need for any such clinical
Clinical Supplies. The Parties have executed a Clinical Development and Supply Agreement, dated October 23, 2012 (“Clinical Supply Agreement”).
(i) With respect to clinical supply of Product to Spectrum, Topotarget shall provide all of Spectrum’s requirements for Product in finished form, labeled and packaged, pursuant to the Clinical Supply Agreement, until such time as existing Topotarget inventory of Product, as specified in Schedule 5.6(a) (the “Existing Topotarget Inventory”), is exhausted. The Parties acknowledge and agree that the Clinical Supply Agreement (including in particular Section 3.8 thereof) remains in full force and effect (except with respect to matters therein pertaining to the negotiation and execution of the “Commercial Supply Agreement”, which are superseded by this Section 5.6) until such time as the Existing Topotarget Inventory is exhausted.
(ii) Upon exhaustion of the Existing Topotarget Inventory, and except as set forth below, Spectrum shall have sole responsibility (either itself or through one or more contract manufacturers) for manufacturing all clinical supplies of Product (including API) for Development worldwide, in current formulations in bulk and finished form. Notwithstanding anything to the contrary in this Agreement, in the Clinical Supply Agreement or any other agreement between the Parties, Spectrum shall have sole responsibility (either itself or through one or more contract manufacturers) for manufacturing all commercial supplies of Product (including API), in current formulation in bulk and finished form. Until the Existing Topotarget Inventory is exhausted, Topotarget shall supply Spectrum’s requirements for clinical supply of Products for the Territory as set forth in the Clinical Supply Agreement and Spectrum (for itself and its sublicensees) shall purchase all of its requirements for clinical supply of Product from Topotarget pursuant to the Clinical Supply Agreement. As of the effective date of the Clinical Supply Agreement, Topotarget’s agreements with any Third Party contract manufacturer for the supply of Product in any formulation are listed on Schedule 2.2 in the Clinical Supply Agreement (the “Manufacturing Agreements”). Topotarget represents that the existing Manufacturing Agreements do not contain any obligations for Spectrum to obtain all or part of its requirements from such Third Parties and Topotarget will take no action or inaction that would result in any such obligation or that would adversely affect Spectrum’s...