Product Complaints definition

Product Complaints means any report concerning the quality, purity, quantity, weight, pharmacologic activity, labeling, identity or appearance of a Product.
Product Complaints shall have the meaning set forth in Section 5.7(a).
Product Complaints means any report concerning the possible failure of a Product to meet any of its specifications, such as quality, purity, quantity, weight, pharmacologic activity, labeling, identity or appearance.

Examples of Product Complaints in a sentence

  • Product Complaints occurring during the study will be followed-up to a satisfactory conclusion.

  • Product Complaints associated with adverse events will be reported in the study summary.

  • All other Adverse Event reports and Product Complaints must be made within one (1) business day.

  • Product Complaints concerning the investigational product and/or device must be reported to the Sponsor within 24 hours of the study site's knowledge of the event via local Product Complaint reporting practices.

  • The Parties shall each collect and record Product Complaints (and any other events required to be recorded under Applicable Laws) in accordance with Applicable Laws and their standard procedures and policies in effect from time to time.

  • SMI shall be responsible for investigating all Product Complaints, shall promptly respond to such complaints and shall copy CryoLife on any response made by SMI.

  • SMI’s obligations shall apply to Product Complaints within and outside the Territory.

  • The responsibilities of the Parties with respect to (a) notification of the Product Complaint from the receiving Party to the other Party and (b) the handling of Product Complaints shall all be performed in accordance with a procedure to be mutually agreed by the Parties after the Effective Date.

  • Product Complaints may require return of the product with the alleged complaint condition (syringe, pen, etc.).

  • CPL shall be responsible for investigating all Product Complaints regarding CPL Products, shall promptly respond to such complaints and shall copy CryoLife on any response made by CPL or SMI.

More Definitions of Product Complaints

Product Complaints means all information related to product complaints.
Product Complaints. Xxxxxx shall complete product complaint forms provided by UroGen to Xxxxxx and forward any product complaint information to UroGen's post-quality assurance group. UroGen and Xxxxxx will work together to manage product complaints in an effective and responsive manner. Should Xxxxxx or its customers receive significant amounts of defective Products, UroGen will issue to Xxxxxx, or to a customer if directed to do so by Xxxxxx, a refund for such Products, including the cost of return shipment for such Products as well as any associated import/export licenses, fees, customs duties and taxes, or, at Xxxxxx'x option, replacement Products, and the cost of shipping such replacement Products as well as any associated import/export licenses, fees, customs duties and taxes shall be at UroGen's expense.

Related to Product Complaints

  • Product Complaint means any written, verbal or electronic expression of dissatisfaction regarding the Product, including without limitation reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

  • Complaints means each of the following documents:

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • Adverse Drug Reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Environmental Complaint shall have the meaning set forth in Section 4.19(d) hereof.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Recall means any measure aimed at achieving the return of a device that has already been made available to the end user;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Adverse Event means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • Product Data means illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • FDA means the United States Food and Drug Administration.

  • Third Party Data has the meaning set forth in Section 9.3(a).

  • Product Know-How means, as related to the Product, all technical, scientific, and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatus, specifications, data, results and other material, including, pre-clinical and clinical trial results, manufacturing procedures, test procedures, and purification and isolation techniques (whether or not confidential, proprietary, patented, or patentable) in written, electronic, or any other form now known or hereafter developed, and all other discoveries, developments, information and inventions (whether or not confidential, proprietary, patented, or patentable), and tangible embodiments of any of the foregoing, including any discoveries, developments, information, or inventions relating to the stability, safety, efficacy, operation, manufacture, ingredients, preparation, indications, presentation, formulation, means of delivery, or dosage of any pharmaceutical composition or preparation.

  • Samples are physical examples that illustrate materials, equipment, or workmanship and establish standards by which the Work will be judged.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Adverse Drug Experience or “ADE” means an Adverse Event associated with the use of the Test Article, that is, an event where there is a reasonable possibility that the Test Article may have caused the event (a relationship between the Test Article and the event cannot be ruled out), in accordance with the definitions of 21 C.F.R. Part 310, 305, or 312, or other applicable regulations.

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Third-Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or