Common use of Production and Quality Control Clause in Contracts

Production and Quality Control. (a) PPTI warrants, represents and covenants that all Materials produced for or sold to Company shall be manufactured free from defects in materials and workmanship and in accordance with specifications set forth in paragraph (b) below. Further, PPTI warrants, represents and covenants that the Materials will meet the specifications in any applicable Regulatory Approvals, including compliance with applicable Quality System Regulations and ISO 9001 Standards in effect at the time of production and/or such other lawful and appropriate standards as the parties may agree upon in writing. Company acknowledges that production specifications may be changed from time to time to comply with applicable laws and regulations. (b) At Company's request, PPTI shall perform one or more of the quality control procedures set forth on Schedule 3 for each lot of Material provided to Company. PPTI shall deliver to Company a copy of test results for each lot of Material supplied to Company. All Material supplied to Company shall have passed such quality control tests and PPTI shall immediately bring to the attention of Company any Material that did not meet such quality control requirements. Materials that meet such quality control requirements and which are not objected to by Company within thirty (30) days after receipt shall be presumed to be free from defects in material and workmanship, in the absence of manifest error. (c) PPTI shall retain samples of all ingredients, packaging materials, records and data as may be in accordance with the sample and record retention policies which PPTI uses in connection with manufacture of Materials for its own account; provided such retention shall at ----------- ***** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. all times be in accordance with all applicable Regulatory Approvals, Quality System Regulations and ISO 9001 Standards. Company shall have the right, no more frequently than once every twelve (12) months, to review PPTI's manufacturing procedures and operations and its records relating to the manufacture and shipment of Materials. No inspection or testing of Materials by Company, or failure to test or inspect, shall relieve PPTI of its obligations hereunder. Copies of any certificates, reports, test results or other information produced by PPTI, or by a third party consultant or contractor at PPTI's request, that directly relate to lots of Material sold to Company shall, upon the written request of Company, be furnished to Company and may be relied upon by it.

Production and Quality Control. Section 3 of the Original Agreement is amended and restated to read as follows: (a) PPTI warrants, represents and covenants that all Materials produced for or sold to Company shall be manufactured free from defects in materials and workmanship and in accordance with written specifications set forth in paragraph (b) belowas mutually agreed upon. Further, PPTI warrants, represents and covenants that the Materials will meet the specifications in any applicable Regulatory Submissions or Regulatory Approvals, as the case may be, in effect at the time of production, including compliance with applicable Quality System Regulations and ISO 9001 Standards as described in effect at the time of production applicable Regulatory Submissions, and/or such other lawful and appropriate standards as the parties may agree upon in writing. PPTI shall not have any responsibility for meeting any changed or new specifications or standards, including, without limitation, manufacturing methods and methods of control in Regulatory Submissions unless PPTI has reviewed and approved in writing any such changed or new specifications or standards. Company acknowledges that production specifications specifications, including, without limitation, manufacturing methods and methods of control, may be changed from time require changes to time obtain and/or maintain Regulatory Approvals and/or to comply with applicable laws and regulations, and that such required changes in production specifications may increase the costs and expenses of the Company and extend the product development timetable of the Company. (b) At Company's request, PPTI shall perform one or more of the quality control procedures set forth on Amended and Restated Schedule 3 for each lot of Material provided to Company. PPTI shall deliver to Company a copy of test results for each lot Lot of Material supplied to Company. All Material supplied to Company shall have passed such quality control tests and PPTI shall immediately bring to the attention of Company any Material that did not meet such quality control requirements. Materials that meet such quality control requirements and which are not objected to by Company within thirty (30) days after receipt shall be presumed to be free from defects in material and workmanship, in the absence of manifest error. (c) PPTI shall retain samples of all ingredients, packaging materials, records and data as may be in accordance with the sample and record retention policies which PPTI uses in connection with manufacture of Materials for its own account; provided such retention shall at ----------- [***** *] Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. connection with manufacture of Materials for its own account; provided such retention shall at all times be in accordance with all applicable Regulatory ApprovalsSubmissions or Regulatory Approvals in effect at the time of production, including compliance with Quality System Regulations and ISO 9001 StandardsStandards as described in the applicable Regulatory Submissions. Company shall have the right, no more frequently than once every twelve (12) months, to review PPTI's manufacturing procedures and operations and its records relating to the manufacture and shipment of Materials. No inspection or testing of Materials by Company, or failure to test or inspect, shall relieve PPTI of its obligations hereunder. Copies of any certificates, reports, test results or other information produced by PPTI, or by a third party consultant or contractor at PPTI's request, that directly relate to lots of Material sold to Company shall, upon the written request of Company, be furnished to Company and may be relied upon by it.

Production and Quality Control. (a) PPTI warrants, represents and covenants that all Materials produced for or sold to Company shall be manufactured free from defects in materials and workmanship and in accordance with specifications set forth in paragraph (b) below. Further, PPTI warrants, represents and covenants that the Materials will meet the specifications in any applicable Regulatory Approvals, including compliance with applicable Quality System Regulations and ISO 9001 Standards in effect at the time of production and/or such other lawful and appropriate standards as the parties may agree upon in writing. Company acknowledges that production specifications may be changed from time to time to comply with applicable laws and regulations. (b) At Company's request, PPTI shall perform one or more of the quality control procedures set forth on Schedule 3 for each lot of Material ---------- provided to Company. PPTI shall deliver to Company a copy of test results for each lot of Material supplied to Company. All Material supplied to Company shall have passed such quality control tests and PPTI shall immediately bring to the attention of Company any Material that did not meet such quality control requirements. Materials that meet such quality control requirements and which are not objected to by Company within thirty (30) days after receipt shall be presumed to be free from defects in material and workmanship, in the absence of manifest error. (c) PPTI shall retain samples of all ingredients, packaging materials, records and data as may be in accordance with the sample and record retention policies which PPTI uses in connection with manufacture of Materials for its own account; provided such retention shall at ----------- ***** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. all times be in accordance with all applicable Regulatory Approvals, Quality System Regulations and ISO 9001 Standards. Company shall have the right, no more frequently than once every twelve (12) months, to review PPTI's manufacturing procedures and operations and its records relating to the manufacture and shipment of Materials. No inspection or testing of Materials by Company, or failure to test or inspect, shall relieve PPTI of its obligations hereunder. Copies of **Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. any certificates, reports, test results or other information produced by PPTI, or by a third party consultant or contractor at PPTI's request, that directly relate to lots of Material sold to Company shall, upon the written request of Company, be furnished to Company and may be relied upon by it.

Production and Quality Control. (a) PPTI Supplier warrants, represents and covenants that all Materials Product produced for or sold to Company Purchaser and its Affiliates shall be manufactured free from defects in materials and workmanship and in accordance with specifications set forth in paragraph (b) below. Further, PPTI warrants, represents approved production protocols and covenants that the Materials will meet the specifications shall be in any applicable Regulatory Approvals, including compliance with applicable Quality System Regulations and ISO IS0 9001 Standards in effect at the time of production and/or such other lawful and appropriate standards as the parties may agree upon in writingupon. Company All Product will have passed suitable Supplier required quality control tests. Purchaser acknowledges that production specifications may be changed from time to time to comply with applicable laws and regulations. (b) At Company's request, PPTI . Supplier shall perform one or more of the quality control procedures set forth on Schedule 3 for each lot of Material provided delivery to Company. PPTI shall deliver to Company Purchaser a copy of test results for each lot of Material Product supplied to Company. All Material supplied to Company Purchaser or its Affiliates. (b) Each of Supplier and Purchaser shall have passed conduct such quality control tests procedures and PPTI inplant quality control checks as it shall immediately deem reasonably necessary. Supplier shall use the same quality control procedures and checks as it applies in the manufacturing of Product for its own use and sale. Purchaser shall audit Supplier's quality control activities and results or conduct its own quality control testing, or provide that its Affiliates, distributors or sub- licensees conduct quality control testing, within 30 days of delivery of Product to Purchaser or direct to Purchaser's Affiliates distributors or sub-licensees. Purchaser shall immediately, and in all events within seven days of discovery or of the end of the 30 day period, whichever shall first occur, bring to the attention of Company Supplier any Material Product that did does not meet such Purchaser's audit or quality control requirementsprocedures and checks. Materials Product lots that meet such Supplier's quality control requirements and which are not objected to by Company Purchaser within thirty (30) 30 days after receipt of delivery as provided above shall be presumed to be free from defects in material and workmanship, in the absence of manifest error. (c) PPTI Each party agrees to notify the other within 48 hours of learning of (i) the failure of any Product to meet standards found in said Product's Regulatory Approval or (ii) third-party complaints pertaining to Product. Purchaser shall use its reasonable efforts to promptly resolve any third party complaints relating to the Product in a manner consistent with Purchaser's approach to the resolution of complaints lodged against other products marketed by Purchaser and its Affiliates (subject to Supplier, as required by Purchaser's quality control manual, providing Purchaser with any information in its possession that may facilitate prompt and favorable resolution of any such complaints and without limitation, within 72 hours of the delivery of the complaint to Supplier). In the event that Purchaser cannot resolve such complaint as aforesaid, Purchaser shall notify Supplier and the parties shall jointly attempt to resolve the problem. (d) In the event that any governmental agency or authority issues a recall or takes similar action in connection with any Product sold or distributed by Purchaser and its Affiliates, its distributors or sub-licensees in a Territory, or Purchaser reasonably considers it necessary to recall Product, Purchaser shall, within 24 hours, advise Supplier by telephone, e-mail or facsimile transmission and Supplier and Purchaser shall agree on an appropriate course of action. Purchaser shall assume complete responsibility for conducting such recall; however, Supplier shall provide Purchaser with any information that may be in Supplier's possession or control concerning the manufacture of the Product which Purchaser reasonably may require to conduct such recall. Supplier and Purchaser shall cooperate to identify and correct deficiencies, if any, in the manufacture, shipment, storage or distribution of the Product. In the event of such a recall or if Supplier requests Purchaser to recall Product, Purchaser and its Affiliates, distributors and sublicensees shall immediately cease all sales of such Product and take all appropriate actions to recall such Product. Supplier shall bear the expenses of any recall requested by it or resulting from (i) defective manufacture, packaging or shipment by Supplier or (ii) any willful misconduct, negligence or gross negligence of Supplier, or any failure of Supplier to comply with the terms of this Agreement, that causes such Product recall. Purchaser shall bear the expenses of any other recall. For the purpose of this Agreement expenses of recall include, without limitation, the expenses of notification and destruction or return of the recalled Products, but not the expense or service fees associated with salesmen's time which shall be borne by Purchaser. (e) Supplier shall retain samples of all ingredients, packaging materials, records and data as may be in accordance with the sample and record retention policies which PPTI Supplier uses in connection with manufacture of Materials Product for its own account; provided such retention shall at ----------- ***** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. all times be in accordance with all applicable Regulatory Approvals, Quality System Regulations and ISO IS0 9001 Standards. Company Purchaser shall have the right, no more frequently than once every twelve (12) monthsfrom time to time, to review PPTISupplier's manufacturing procedures and operations and its records relating to the manufacture and shipment of MaterialsProduct. No inspection or testing of Materials Product by CompanyPurchaser, or failure to test or inspect, shall relieve PPTI Supplier of its obligations hereunder. Copies of any certificates, reports, test results or other information produced by PPTISupplier, or by a third party consultant or contractor at PPTISupplier's request, that directly relate to lots of Material Product sold to Company Purchaser shall, upon the written request of CompanyPurchaser, be furnished to Company Purchaser and may be relied upon by it. (f) The parties recognize that the holder of or applicant for Regulatory Approvals for a country may be required to submit information and file reports to various governmental agencies on Product under clinical investigation, Product proposed for Commercialization, or Commercialized Product. Consequently, each party agrees to provide to the other within three (3) business days of the initial receipt of a report of any adverse experience with Product that is serious or unexpected. Serious adverse experience means any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigatory brochure or labeling for the Product. In the case experience or unexpected adverse experience relating to such Product so that Purchaser can report such experience to Supplier pursuant to the provisions hereunder.