Study Product Sample Clauses

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.
Sample 1Sample 2Sample 3See All (4)
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Study Product. Sponsor agrees to provide the Study Product to Institution, at no cost to Institution, in amounts sufficient for the conduct of
Sample 1
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...
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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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.
Sample 1

Related to Study Product

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

  • 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.

  • 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.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

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