Product Quality Complaint is defined as any complaint that questions the purity, identity, potency or quality of either of the Products, its packaging, or labeling, or any complaint that concerns any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specifications therefor in the NDA for the Products. Such information shall be sent to WC as set forth in Section 8.2.3
Product Quality Complaint means any and all manufacturing or packaging-related complaints related to the Product, including (i) any complaint involving the possible failure of the Product to meet any of the specifications for the Product; (ii) any dissatisfaction with the design, package or labeling of the Product; or (iii) any Adverse Event that may involve the quality of the Product.
Product Quality Complaint means an oral or written report, originating from an external or internal source, stating that a product marketed by Medical Imaging is not meeting the customer’s expectations in relation to identity, quality, effectiveness or performance of the product.
Examples of Product Quality Complaint in a sentence
A Product Quality Complaint may or may not require further investigation and refund or exchange to retail customer is based on Store Operator’s return policies.
In addition, such information may be disclosed by one Party upon the prior written consent of the other Party to any Third Party who manufactured a pertinent component of the applicable Product for BMS in connection with an investigation of an adverse event or Product Quality Complaint.
Distributor shall notify Company of any Product Quality Complaint promptly and in any event within twenty-four (24) hours of Distributor’s receipt of such Product Quality Complaint.
With respect to Product Quality Complaints received by a CAM or other Spectrum Personnel, such Spectrum Personnel shall promptly refer such Product Quality Complaint to Eagle’s call center for management of the report.
Spectrum shall, at Eagle’s expense, cooperate with Eagle’s reasonable requests and use its Commercially Reasonable Efforts to assist Eagle, as may be reasonably requested by Eagle, in connection with (a) preparing any and all reports with respect to any of the Products in the Territory for submission to any Regulatory Authority, and (b) investigating and responding to any Product Quality Complaint related to any of the Products in the Territory.
More Definitions of Product Quality Complaint
Product Quality Complaint means any complaint that questions the purity, identity, potency or quality of the Active Ingredient.
Product Quality Complaint. (PQC) Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a product after it is released for distribution.
Product Quality Complaint means any legitimate complaint (as reasonably determined by the Party receiving such complaint) by a Third Party that (a) questions the purity, identity, potency or quality of the Product, its packaging, or labeling, or (b) claims that the Product or its labeling is mistaken for, or applied to, another article or any bacteriological contamination, or (c) claims a significant chemical, physical, or other change or deterioration exists in the distributed drug product, or (d) claims a failure of one or more distributed batches of Product to meet the specifications thereof.
Product Quality Complaint shalt mean any and all Manufacturing or packaging-related complaints from Third Parties related to the Distribution Product, including (a) any complaint involving the possible failure of the Distribution Product to meet any applicable Specifications, (b) any dissatisfaction with the design, package or labeling of the Distribution Product; or (c) any adverse event that may involve the quality of the Distribution Product, including lack of effect, infection, or request for testing.
Product Quality Complaint means any and all manufacturing or packaging-related complaints related to the Product, including (a) any complaint involving the possible failure of the Product to meet any of the specifications for the Product and (b) any dissatisfaction with the design, - 5 - package or labeling of the Product.
Product Quality Complaint is defined as any complaint that questions the purity, identity, potency or quality of the Product, its packaging, or labeling, or any complaint that concerns any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specifications therefor in the NDA for the Product. Such information shall be sent to the same address as set forth in Section 9.3 above. BMS shall be solely responsible for responding to any such Product Quality Complaints.
Product Quality Complaint means any and all manufacturing or packaging-related complaints related to the Product, including without limitation (a) any complaint involving the possible failure of the Product to meet any of the specifications for the Product and (b) any dissatisfaction with the design, package or labeling of the Product. 1.55. “Product Trademarks” means the trademarks used for the Product that are controlled by Zosano during the Term in the Territory, including without limitation any such trademarks for the Product used in the Prescribing Information, Promotional Materials, training materials or other material provided hereunder or otherwise authorized or approved by Zosano, excluding the Corporate Trademarks. 1.56. “Regulatory Authority” means any national, federal, state, or local governmental or regulatory authority, agency, department, bureau, commission, council or other government entity located in the Territory, including without limitation FDA, Centers for Medicare and Medicaid Services (CMS), and the Office of Inspector General of the U.S. Department of Health and Human Services, regulating or otherwise (a) exercising authority with respect to the development, manufacture, approval, registrations, licensing, or commercialization of the Product in such regulatory jurisdiction in the Territory, or (b) having legal authority with respect to the exploitation of the Product in the Territory. 1.57. “Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals, all correspondence submitted to or received from Regulatory Authorities (including without limitation minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to the Product, and all data contained in any of the foregoing, including without limitation all Regulatory Authority approvals, regulatory drug lists, advertising and promotion documents and related FDA submissions and correspondence, adverse event files and complaint files and related FDA submissions. 1.58. “Sales Force” shall have the meaning set forth in Section 3.2.e. 1.59. “Sales & Promotion Policies” means Eversana’s compliance policies and other policies generally applicable to the Commercialization of pharmaceutical products in the Territory, in 7