Study Product Sample Clauses
The 'Study Product' clause defines the specific drug, device, or intervention that will be used or tested in a clinical study. It typically outlines the characteristics, formulation, and source of the product, and may specify requirements for labeling, storage, and handling. By clearly identifying what constitutes the study product, this clause ensures all parties understand exactly what is being administered or investigated, thereby preventing confusion and ensuring regulatory compliance.
Study Product. 2.5.1 Sponsor shall provide free of charge, or as appropriate, reimburse Institution for materials that Sponsor is required to provide per the Protocol including Study Product necessary for the conduct of the Study.
2.5.2 Institution/Principal Investigator shall ensure that the Study Product are handled correctly and stored securely for the duration of the Study and any period thereafter as required by applicable law or this Agreement, whichever is later, in accordance with the Protocol.
2.5.3 Only those persons who are under the Principal Investigator's direct control and who will be using the Study Product shall have access to the Study Product.
2.5.4 Institution/Principal Investigator shall not use the Study Product for any purpose other than the conduct of the Study.
2.5.5 Upon termination or completion of the Study, all unused Study Product shall be returned to Sponsor at Sponsors expense or, at Sponsor's sole option and at Sponsor’s expense, destroyed.
Study Product. Sponsor agrees to provide the Study Product to Institution, at no cost to Institution, in amounts sufficient for the conduct of
Study Product. 5.1. As part of the support provided by the COMPANY, COMPANY will provide 66 units of Stratafix Symmetric PDS Plus (barbed suture) free of charge for eligible patients who are enrolled in the Study until such time as they complete the Study.
5.2. COMPANY is responsible for the initiation of the delivery of the Study Product. COMPANY will provide support to the SPONSOR and PRINCIPAL INVESTIGATOR to enable them to comply with the SPONSOR 's duties related to the manufacturing, packaging, labeling and coding, supplying and handling of the Study Product and related information to be submitted to the competent Health Authorities where required. COMPANY declares and warrants that the Study Product will be manufactured and controlled in compliance with Good Manufacturing Practices.
5.3. SPONSOR declares and warrants to label the Study Product for the only use within the scope of the Study. SPONSOR declares and warrants to use the Study Product only for the conduction of the Study. SPONSOR and PRINCIPAL INVESTIGATOR shall be responsible for complete product accountability in accordance with good clinical practices and agree that Study Product provided by COMPANY under the terms of this Agreement shall be used only for this Study and its enrolled subjects. SPONSOR will ensure that the Study Product will be stored adequately and that no expired Study Product will be given to any subject in this Study.
5.4. At the end or termination of this Study, all Study Products shall be returned to COMPANY.
5.5. SPONSOR and PRINCIPAL INVESTIGATOR will not submit bills to third party payment programs for the distribution or use of the free Study Product supplied by COMPANY in good faith solely for the use of subjects enrolled in the Study, nor will SPONSOR and/or PRINCIPAL INVESTIGATOR bill third party programs for the services rendered to administer infusions of Study Product to Study subjects.
Study Product. For purposes of this Safety Data Exchange Agreement, “Study Product” means any test article that contains (or, if the study blind is not broke in a clinical trial, may contain) Matrix-MTM adjuvant administered in conjunction with vaccine antigens or alone.
Study Product. PHRI shall provide Site with sufficient amount of drug products required for use in the Study (“Product”) upon receipt of all documents required by PHRI. Site shall: (a) only use the Product provided by PHRI and not from other sources for the Study, (b) use the Product solely for the purposes of conducting the Study, and (c) ensure the Product is stored in accordance with the instructions provided by PHRI in the pharmacy questionnaire, the Protocol, and the Product labels. Site shall control and/or limit access to the Product to the Personnel, and provide up-to-date records showing receipt, dispensing and returns of the Product in accordance the Protocol and Applicable Laws. After completion of the Study, Site shall dispose of or return the Product in accordance with the instructions from PHRI.
Study Product. Sponsor agrees to provide vBloc Maestro® Rechargeable System (the “Study Product”) in amounts necessary to conduct the Study. Sponsor will provide the Study Product free of charge to the Institution. Institution and Investigator agree that the Study Product will be used solely for purposes of performing the Protocol under this Agreement. At the completion of the Study, Institution shall return any remaining Study Product to Sponsor, unless otherwise instructed by Sponsor.
Study Product. 13.1 You must supply us or the Study Site (as specified in a Study Order) with such quantities of the Study Product as will be required for the purpose of the Study. You must ensure that all supplied Study Product will be packaged in safe and appropriately labelled containers. You will at all times remain the owner of the Study Product.
13.2 If specified in a Study Order, on termination or expiry of this Agreement, we must promptly return any unused Study Product to you, or under your guidance appropriately destroy expired and / or unused product.
Study Product. 5.1 As part of the support provided by the COMPANY, COMPANY will provide to designated depos in Europe BST-236 (the “Study Product”) in quantities to support the Protocol free of charge for eligible Subjects who are enrolled in the Study until such time as they complete the Study in accordance with the Protocol or the Study is otherwise terminated. This amount excludes any Study Product replaced due to either expiry dating, recall or damage, unless such expiration, recall or damage is attributable to any action or inaction taken by the INSTITUTION, PRINCIPAL INVESTIGATOR, or Study personnel. Not otherwise limiting the foregoing, INSTITUTION shall use reasonable efforts to provide COMPANY with a quarterly demand forecast for bulk planning purposes. INSTITUTION and PRINCIPAL INVESTIGATOR shall not order or collect from the designated depos in Europe quantity of the Study Product that exceeds the quantity actually required for the enrolled eligible Subjects under the Protocol.
5.2 COMPANY will also provide, to the extent applicable, reasonable support to INSTITUTION and PRINCIPAL INVESTIGATOR to enable them to comply with their sponsor’s duties related to the manufacturing, supplying and quality of the Study Product (including those described in the International Conference on Harmonization Guidelines for Good Manufacturing Practices (“ICH GMPs”)) and related information to be submitted to the competent Health Authorities. If COMPANY initiates a recall, INSTITUTION and PRINCIPAL INVESTIGATOR shall comply with this recall.
5.2.1. COMPANY and INSTITUTION shall promptly provide each other with any data or information in their possession (e.g., defective packaging material) that could result in a recall of the Study Product.
5.2.2. In the event of a potential or actual recall of Study Product already delivered to INSTITUTION or its designee, COMPANY and INSTITUTION shall consult and cooperate on any recall decision with the aim of reaching an agreement. COMPANY shall be responsible for the final recall decision for such Study Product and the INSTITUTION shall be responsible for any resulting communication with third parties.
5.3 COMPANY declares and warrants that the Study Product will be manufactured and controlled in compliance with the ICH GMPs. Notwithstanding anything herein to the contrary, COMPANY shall be entitled to subcontract the packaging, labeling, testing, release and delivery of Study Product, whether in whole or in part, to the third-party contrac...
Study Product. PHRI shall provide the site, free of charge, with sufficient amount of drug products or medical devices required for use in the Study (“Product”) upon receipt of all documents required by PHRI. Site shall: (a) only use the Product provided by PHRI and not from other sources for the Study, (b) use the Product solely for the purposes of conducting the Study, and (c) ensure the Product is stored in accordance with the instructions provided by PHRI and the Product labels. Site shall control and/or limit access to the Product to the Personnel, and provide up-to-date records showing receipt, dispensing and returns of the Product in accordance the Protocol and Applicable Laws. After completion of the Study, Site shall dispose of or return the Product in accordance with the 1.13 Produkt studie: PHRI poskytne bezplatně Místu výkonu klinického hodnocení dostatečné množství léčivých přípravků nebo zdravotnických prostředků potřebných pro použití v rámci Studie (dále jen „Produkt“) po obdržení všech požadovaných dokumentů. Místo výkonu klinického hodnocení je povinno: (a) používat pro Studii pouze Produkt poskytnutý PHRI a ne z jiných zdrojů, (b) používat Produkt pouze pro účely provádění Studie a (c) zajistit, aby byl Produkt uchováván v souladu s pokyny poskytnutými PHRI a pokyny na etiketě Produktu. Místo výkonu klinického hodnocení bude kontrolovat a/nebo omezovat přístup Pracovníků k Produktu a zajistí aktuální záznamy potvrzující příjem, výdej a vrácení Produktu v souladu s Protokolem a Platnými zákony. Po dokončení instructions from and the cost of PHRI. The costs are already included in the per patient fees in Exhibit 1 Studie Místo výkonu klinického hodnocení zlikviduje Produkt v souladu s pokyny a na náklady PHRI. Tyto náklady jsou již součástí odměny za pacienta, uvedené v Příloze 1.