Investigational Product Labeling & Accountability Sample Clauses

Investigational Product Labeling & Accountability. The Investigator should take adequate precautions, including access to the Investigational product to prevent diversion of the VSA app into unauthorized channels of distribution. The VSA app is classified as a Mobile Medical App (per FDA Guidance Policy for Device Software Functions and Mobile Medical Applications issued September 2019) under enforcement discretion. The VSA appwill be labeled with the following: “CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use.” Only Institutions/Investigators participating in the clinical study will be eligible to receive the VSA app and can be used only when the following has been received: ● Curriculum Vitae of the Investigator ● A signed Investigator AgreementInstitutional Review Board (IRB) approval ● IRB-approved Informed Consent Form 11. Regulatory, Ethical and Study Oversight Considerations
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Related to Investigational Product Labeling & Accountability

  • Product Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.

  • Authorized User Overview and Mini-Bid Process Project Based IT Consulting Services Contracts enable Authorized Users to use a competitive Mini-bid Process to acquire Services on an as-needed basis, for qualified IT Projects. Project Based IT Consulting Services may include, but will not be limited to projects requiring: analysis, data classification, design, development, testing, quality assurance, security and associated training for Information Technology based applications. See section 1.3 Out of Scope Work for a listing of projects expressly excluded from the scope of this Contract. An Authorized User Agreement for Project Based IT Consulting Services will be governed first by the terms and conditions specified in the OGS Centralized Contract and second by terms and conditions added to the Authorized User Statement of Work. Additional terms and conditions shall not conflict with or modify the terms and conditions of the OGS Centralized Contract. NYS Executive Agencies must adhere to all internal processes and approvals including, as required, approval from NYS Office of Information Technology Services. Other Authorized Users must adhere to their own internal processes and approvals. In accordance with Appendix B, section 28, Modification of Contract Terms, an Authorized User may add additional required terms and conditions to this Mini-Bid and resultant Authorized User Agreement only if such terms and conditions (1) are more favorable to the Authorized User and (2) do not conflict with or supersede the OGS Centralized Contract terms and conditions. Examples of additional terms and conditions include: • Expedited delivery timeframe; • Additional incentives, such as discount for expedited payment/Procurement Card use; and • Any additional requirements imposed by the funding source or Federal law.

  • Labelling The distributor, on behalf of the selected vendor agrees that all supplies of articles should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. The label should contain :

  • OUT OF STOCK, PRODUCT RECALLS, AND DISCONTINUED PRODUCTS H-GAC does NOT purchase the products sold pursuant to a Solicitation or Agreement. Contractor is responsible for ensuring that notices and mailings, such as Out of Stock or Discontinued Notices, Safety Alerts, Safety Recall Notices, and customer surveys, are sent directly to the Customer with a copy sent to H-GAC. Customer will have the option of accepting any equivalent product or canceling the item from Customer’s Purchase Order. Contractor is not authorized to make substitutions without prior approval.

  • Labeling Upon request, Lessee will xxxx the Equipment indicating Lessor's interest with labels provided by Lessor. Lessee will keep all Equipment free from any other marking or labeling which might be interpreted as a claim of ownership.

  • Prohibition Against Selecting and Installing Products Containing Hazardous Materials The Contractor shall not select, install or otherwise incorporate any products or materials containing Hazardous Materials within the boundaries of the Site. Should the Contractor or any Subcontractors have knowledge that, or believe that, an item, component, material, substance, or accessory within a product or assembly selected by the Contractor or any Subcontractor may contain Hazardous Materials it is the Contractor’s responsibility to secure a written certification from the manufacturer of any suspected material which identifies the specific Hazardous Material(s) contained, together with the Material Safety Data Sheets (MSDS) for such materials which shall be submitted to the Owner and Design Professional.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Promotional Materials In the event that the Fund or the Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Adviser will install and maintain, or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • Computer Equipment Recycling Program If this Contract is for the purchase or lease of computer equipment, then Contractor certifies that it is in compliance with Subchapter Y, Chapter 361 of the Texas Health and Safety Code related to the Computer Equipment Recycling Program and the Texas Commission on Environmental Quality rules in 30 TAC Chapter 328.

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