Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA. Collaborator will provide a Certificate of Analysis to ICD for each lot of the Test Article provided.
Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) studies based on the Research Plan and Protocol mutually agreed to and approved upon by the Parties under this CRADA. ICD will provide to Collaborator at least six (6) months in advance of the required delivery date of such supply. Updated forecasts will be provided for the amounts of Test Article anticipated for ongoing and anticipated mutually agreed upon clinical studies conducted under this CRADA. Collaborator further agrees to provide draft Investigational Agent labels to the NCI Pharmaceutical Management Branch (PMB) for review and agrees to reasonable labeling revisions to comply with ICD label guidelines, which guidelines shall be provided to Collaborator sufficiently in advance. NCI NSC (National Service Center) numbers provided by ICD will be required to be on the label of Investigational Agent for all ICD-sponsored clinical trials. Collaborator will provide a Certificate of Analysis to ICD for each lot of the finished Test Article provided.
Test Article Information and Supply. Collaborator agrees to provide VA, without charge and on a schedule that shall ensure timely performance of the SOW, a sufficient quantity of acceptably labeled Test Article and, if required by the Protocol, any placebo, comparator device, or supplemental drug necessary to complete the SOW. Collaborator shall provide to VA information regarding safety and efficacy data from clinical and non-clinical studies, recommended dosage or usage, storage and known risks or contraindications, if any.
Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA, where Collaborator holds the IND for these studies. Collaborator will provide a Certificate of Analysis to ICD for each lot of the Test Article provided. ICD agrees to supply a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article to complete the clinical trial(s) under this CRADA, where ICD holds the IND for these studies, ICD will maintain a Certificate of Analysis for each lot of the Test Article provided. Amend Section 3.9 to read as follows:
Test Article Information and Supply. Collaborator, through its designee, agrees to provide to IC’s Clinical Research Sites, without charge and on a schedule agreed by both Parties, a sufficient quantity of formulated and acceptably labeled Test Article (and Placebo) to complete the Clinical Trial agreed to and approved under this CRADA. Collaborator, through its designee, will provide a Certificate of Analysis to the Clinical Research Sites for each lot of the Test Article provided.
Test Article Information and Supply. (A) Entity will provide Test Article in sufficient quantity as needed to complete the Protocol. Entity will provide Certificates of Analysis to IC for each lot of finished Test Article provided. Entity’s obligation to provide Test Article in sufficient quantities extends beyond the termination of this Agreement as needed to complete the Protocol, unless termination is for safety concerns. The IC contact is [Insert IC contact name] (Telephone Number [Insert IC contact phone number with area code] ) and the Entity contact is [Insert Entity contact name] (Telephone Number [Insert Entity contact phone number with area code]).
(B) Entity will not be providing funding or any other financial support directly to IC or IC investigator under this Agreement.
Test Article Information and Supply. Collaborator agrees to use reasonable efforts to provide IC, or its designee as agreed, and on a schedule that will ensure adequate and timely performance of the Research Plan a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA without charge to IC or its designee. Collaborator and IC will agree upon a drug supply schedule which will ensure adequate and timely performance of the Research Plan, prior to commencement of the treatment of the first Human Subject. Collaborator will provide a Certificate of Analysis to IC for each lot of the Test Article provided.
Test Article Information and Supply. 3.8.1 Collaborator agrees to provide IC without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA. If applicable, Collaborator agrees to provide Test Article labels to the IC. Collaborator will provide a Certificate of Analysis (COA) to IC in advance of an IND filing and for each lot of the Test Article provided.
3.8.2 The Test Article must be received by the IC in usable condition and accompanied by specific storage and shipping instructions, Material Safety Data Sheet (MSDS), a signed and dated COA, and stability or expiration dating information for each lot of Test Article sent. If the Collaborator performs ongoing stability testing for each lot of Test Article sent, then the Collaborator will also provide updated retest or expiration dates for those respective lots to the IC in a timely manner.
3.8.3 If there is evidence that the Test Article that arrived at the IC has not been maintained according to the defined shipping instructions or there is evidence of damage to the Test Article container or container closure system, IC will contact the Collaborator to inform them of the condition of the received Test Article and to determine together with the Collaborator whether the Test Article is usable or if it must be replaced. During the course of the clinical studies, the same process will be used whenever there is evidence that the Test Article has not been maintained according to the Collaborator’s recommended storage conditions. If the Test Article must be replaced, the Collaborator will replace it at no cost to IC.
Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as PHS ECT-CRADA Case Ref. No. _______ MODEL ADOPTED 2005 [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA. Collaborator will provide a Certificate of Analysis to ICD for each lot of the Test Article provided.
Test Article Information and Supply. Collaborator agrees to provide VA, without charge and on a schedule that shall ensure timely performance of the Protocol, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article and, if required by the Protocol, any placebo, comparator, or supplemental drug necessary to complete the Protocol. Collaborator shall provide to VA information regarding safety and efficacy data from clinical and non-clinical studies, recommended dosage or usage, storage and known risks or contraindications, if any.
