Clinical Specimens for Use in Protocol Sample Clauses

Clinical Specimens for Use in Protocol. All clinical specimens and isolates collected by the Investigators, or their staff, under this Clinical Trial are deliverables to NIAID under the Clinical Research Site Contract and shall remain in the custody of NIAID. During the Clinical Trial, the NIAID may provide the Company with aliquots of clinical specimens as needed for Protocol-related purposes only. For this Protocol, the Company may be provided with serum specimens to run pharmacokinetics (PK) and immunogenicity analyses. The Company will pay for the shipment of these clinical specimens from the Clinical Research Site or Distributor to the Company or its designated laboratory and their testing according to the Protocol. However, nothing in this Agreement will be interpreted to transfer ownership to the Company.
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Clinical Specimens for Use in Protocol. All clinical specimens and isolates collected under this Clinical Trial will be and remain in the custody of NHLBI. However, NHLBI will provide Company with clinical specimens and isolates for analysis as stated in the Protocol. Company agrees to share with NHLBI results derived from the analysis of clinical specimens and isolates.
Clinical Specimens for Use in Protocol. All clinical specimens and isolates collected by the Investigators, or their staff, under this Clinical Trial will be and remain in the custody of XXXXX. [OPTIONAL TEXT: NIAID may transfer clinical specimens and isolates to its contractors or third parties for further analyses consistent with the Protocol.]] [OPTIONAL TEXT - If the Company may/will be provided with specimens/isolates for protocol related purposes, add to 9.8: “During the Clinical Trial, the NIAID may/will provide the Company with aliquots of clinical specimens as needed for Protocol-related purposes only. The Company will pay for the shipment of these clinical specimens from the Clinical Research Site to the Company or its designated laboratory and their testing according to the Protocol. However, nothing in this Agreement will be interpreted to transfer ownership to the Company.”] [OPTIONAL TEXT:

Related to Clinical Specimens for Use in Protocol

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Pricing). PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. PCI reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Training Materials Training Materials will be provided for each student. Training Materials may be used only for either (i) the individual student’s reference during Boeing provided training and for review thereafter or (ii) Customer’s provision of training to individuals directly employed by the Customer.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

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