Common use of Conformity; Specifications; Quality Control Clause in Contracts

Conformity; Specifications; Quality Control. (a) All quantities of API supplied by the Company pursuant to this Section 8 will comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API at the time it is shipped by the Company hereunder. (b) Changes to the Specifications shall be made only by the JMC. (c) The Company shall conduct, or cause to be conducted, quality control testing of API prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time (collectively, the "Testing Methods"). Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company shall undertake all such tests. The Company shall retain records pertaining to such testing. Each shipment of API hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API therein as well as such customs and other documentation as is necessary or appropriate. (d) ERS shall have the right, at reasonable times and upon reasonable notice, to inspect all facilities at which API is manufactured pursuant to this Section 8 for compliance with cGMP, subject to existing agreements with Third Party Manufacturers. (e) All units of Finished Product manufactured pursuant to this Agreement will comply in all material respects with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testing.

Conformity; Specifications; Quality Control. (a) All quantities of API Finished Products and/or Samples supplied by the Company Indevus pursuant to this Section 8 Article 14 will comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere conform in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API at the time it is shipped by the Company hereunderSpecifications. (b) Changes to the Specifications shall be made only by the JMC. (c) The Company Indevus shall conduct, or cause to be conducted, quality control testing of API Finished Products and/or Samples prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC Indevus from time to time (collectively, the "Testing Methods"). Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company shall undertake all such tests. The Company shall retain records pertaining to such testing. Each shipment of API hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API therein as well as such customs and other documentation as is necessary or appropriatetime. (dc) ERS Each Party shall have the right, at reasonable times and upon reasonable notice, to inspect and audit all facilities at which API is Finished Products and/or Samples are manufactured and quality control tested pursuant to this Section 8 Article 14 for compliance with cGMP, subject to Indevus’ existing agreements with Third Party Manufacturers. (ed) All units of Finished Product manufactured pursuant The Parties agree to negotiate in good faith to enter into a mutually agreeable quality control agreement relating to, (i) prior to the Processing Assumption Date, the supply by Indevus to Esprit under this Agreement will comply in all material respects with the applicable Manufacturing Standards and specifications for of Trospium Once-Daily Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations relating and/or Samples, (ii) prior to the manufactureNDA Transfer Date, sale and shipment the supply by Indevus to Esprit under this Agreement of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Trospium Twice-Daily Finished Products and/or Samples, and (either ERS or iii) after the Company Processing Assumption Date (A) and prior to the extent that NDA Transfer Date, the Company is responsible for processing API into supply by Esprit under this Agreement of Trospium Once-Daily Finished Products pursuant and/or Samples, and (B) if the Ex-US Supply Agreement is entered into, the supply by Esprit to Section 8.1(b)) shall conduct, Indevus of Trospium Once-Daily Finished Products and/or Samples or cause to be conducted, quality control testing bulk capsules of each Finished Product Trospium Once-Daily prior to shipmentbeing in its finished, labeled and packaged form, for use in accordance with jurisdictions outside the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testingTerritory.

Conformity; Specifications; Quality Control. (a) All quantities of API Product, Finished Product and Implanters supplied by the Company DURECT pursuant to this Section 8 will Agreement shall comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API Product, Finished Product and Implanters at the time it is shipped by the Company DURECT hereunder. (b) Changes to the Specifications shall be made only by the JMC, subject to the Parties' right to challenge such changes pursuant to this Agreement. DURECT shall ensure that all such changes shall be reflected in all Regulatory Authority filings. (c) The Company DURECT shall conduct, or cause to be conducted, quality control testing of API Product, Finished Product and Implanters prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time (collectively, the "Testing Methods"). Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company DURECT shall undertake all such tests. The Company DURECT shall retain records pertaining to such testing. Each shipment of API Product, Finished Product and Implanters hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API Product, Finished Product and Implanters therein as well as such customs and other documentation as is necessary or appropriate. (d) ERS Endo shall have the right, at reasonable times and upon reasonable notice, to inspect and audit all DURECT facilities at which API is Product, Finished Product or Implanters are manufactured pursuant to this Section 8 for purposes of determining compliance with the terms of this Agreement, including cGMP, subject . DURECT shall use all reasonable commercial efforts to existing agreements with gain access to the facilities of Third Party ManufacturersManufacturers at which Product, Finished Product or Implanters are manufactured for Endo to so audit such facilities for purposes of determining compliance with the terms of this Agreement, including cGMP. (e) All units of DURECT shall ensure that each Product, Finished Product manufactured pursuant and Implanters, when delivered to this Agreement will comply Endo, meets the Specifications and Manufacturing Standards, and the standards of Product and Finished Product identity, strength, quality and purity set forth in the NDA. In addition, DURECT shall ensure that all material respects Product, Finished Product, Implanters and, if Commercialized hereunder, Implant Kits supplied to Endo or its Affiliates, Sublicensees or designees shall (i) meet all applicable requirements of any relevant Regulatory Authority in the Territory and any other applicable laws or regulations, (ii) be manufactured, packaged, tested, stored and shipped in accordance with applicable cGMPs, and applicable law or regulation, and (iii) be produced, packaged, tested and stored in facilities that have been approved by the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufactureRegulatory Authority, sale and shipment of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, required by applicable law or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testingregulation.

Conformity; Specifications; Quality Control. (a) All quantities of API Deliverables supplied by the Company Oncura pursuant to this Section 8 5 will comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API the Deliverable at the time it is shipped by the Company Oncura hereunder. (b) Changes to the Specifications shall be made only by the JMC. (c) The Company Oncura shall conduct, or cause to be conducted, quality control testing of API the Deliverables prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC Parties from time to time (collectively, the "Testing Methods"). Initially and until decided otherwise by the JMCParties, the Testing Methods shall include all FDA and other Regulatory Authority required release testing testing, based upon the delivery location of the I-125 Products, and the Company Oncura shall undertake all such tests. The Company Oncura shall retain records pertaining to such testing, which shall be made available to IsoRay upon request. Each shipment of API Deliverables hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API Deliverables therein as well as such customs and other documentation as is necessary or appropriate. (d) ERS shall have the right, at reasonable times and upon reasonable notice, to inspect all facilities at which API is manufactured pursuant to this Section 8 for compliance with cGMP, subject to existing agreements with Third Party Manufacturers. (ec) All units of Finished Product manufactured pursuant to this Agreement will comply in all material respects with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC Parties and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testing.

Conformity; Specifications; Quality Control. (a) All quantities of API Product, Finished Product and Implanters supplied by the Company DURECT pursuant to this Section 8 will Agreement shall comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API Product, Finished Product and Implanters at the time it is shipped by the Company DURECT hereunder. (b) Changes to the Specifications shall be made only by the JMC, subject to the Parties’ right to challenge such changes pursuant to this Agreement. DURECT shall ensure that all such changes shall be reflected in all Regulatory Authority filings. (c) The Company DURECT shall conduct, or cause to be conducted, quality control testing of API Product, Finished Product and Implanters prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time (collectively, the "“Testing Methods"”). Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company DURECT shall undertake all such tests. The Company DURECT shall retain records pertaining to such testing. Each shipment of API Product, Finished Product and Implanters hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API Product, Finished Product and Implanters therein as well as such customs and other documentation as is necessary or appropriate. (d) ERS Endo shall have the right, at reasonable times and upon reasonable notice, to inspect and audit all DURECT facilities at which API is Product, Finished Product or Implanters are manufactured pursuant to this Section 8 for purposes of determining compliance with the terms of this Agreement, including cGMP, subject . DURECT shall use all reasonable commercial efforts to existing agreements with gain access to the facilities of Third Party ManufacturersManufacturers at which Product, Finished Product or Implanters are manufactured for Endo to so audit such facilities for purposes of determining compliance with the terms of this Agreement, including cGMP. (e) All units of DURECT shall ensure that each Product, Finished Product manufactured pursuant and Implanters, when delivered to this Agreement will comply Endo, meets the Specifications and Manufacturing Standards, and the standards of Product and Finished Product identity, strength, quality and purity set forth in the NDA. In addition, DURECT shall ensure that all material respects Product, Finished Product, Implanters and, if Commercialized hereunder, Implant Kits supplied to Endo or its Affiliates, Sublicensees or designees shall (i) meet all applicable requirements of any relevant Regulatory Authority in the Territory and any other applicable laws or regulations, (ii) be manufactured, packaged, tested, stored and shipped in accordance with applicable cGMPs, and applicable law or regulation, and (iii) be produced, packaged, tested and stored in facilities that have been approved by the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufactureRegulatory Authority, sale and shipment of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, required by applicable law or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testingregulation.

Conformity; Specifications; Quality Control. 8.5.1 Tris represents and warrants that all Product and/or Anti-caking Complex supplied hereunder will be manufactured, stored and tested at facilities which are approved by the FDA and any other relevant Regulatory Authority and shall conform with the current cGMP and Specifications in effect for the Product and Anti-caking Complex at the time of shipment and any other mandatory standards for the Product and Anti-caking Complex, in accordance with the regulatory specifications and methods described and approved in the Registration and that the Product and Anti-caking Complex when delivered will not be adulterated or misbranded under the FDA Act and will have an expiry date of at least eighteen (18) months from the date of delivery to Alpharma; provided that Tris shall use reasonable commercial efforts to take such actions as necessary to obtain a longer expiry date from the appropriate Regulatory Authority. Tris will take all actions reasonably required to receive all required DEA approvals in order to purchase adequate quantities of API for the Product and Anti-caking Complex required to be supplied to Alpharma from a supplier or suppliers designated by Alpharma. 8.5.2 Tris shall have the right to change, and Alpharma shall have the right to request a change in, the Specifications of any of the Products or the Anti-caking Complex if, in such Party's reasonable opinion, such Product or Anti-caking Complex when manufactured in accordance with the then-current Specifications is likely to infringe the intellectual property rights of a Third Party; provided, that, in no event shall any modification be made to the method or process of manufacture or production of the Product or Anti-caking Complex, which modification shall have the effect of requiring Alpharma to supplement or amend the Registration of any of the Product, without the written consent of Alpharma, which shall not be unreasonably withheld. 8.5.3 Either Party shall have the right to request a change to the Specifications, from time to time, to accommodate the demands or requests of any applicable Regulatory Authority in the Territory, at any time during the Term, on not less than twelve (12)-months' (or such shorter period required by a Regulatory Authority) prior written notice to the other Party; provided that all changes to Specifications shall be implemented pursuant to the formal change control policy as set forth in the Commercial Supply Agreement. (a) All quantities of API supplied by To the Company extent that Tris desires to implement any change to Specifications which is not required pursuant to this Section 8 will comply 8.5.3(c), Tris shall obtain the consent of Alpharma (which shall not be unreasonably withheld or delayed) regarding such proposed change to Specifications. If consent from Alpharma is obtained, Tris shall be responsible for making any required filing with respect to such change and for any for the cost and expense of implementing such change to Specifications, including any costs and expenses incurred by Alpharma in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API at the time it is shipped by the Company hereunderconnection therewith. (b) Changes To the extent that Alpharma desires to have any change to Specifications implemented which is not required pursuant to Section 8.5.3(c), Alpharma shall obtain the consent of Tris (which shall not be unreasonably withheld or delayed) regarding such proposed change to Specifications. If consent from Tris is obtained, Alpharma shall be responsible for making any such change to the Specifications shall be made only Specifications, including the cost and expense of implementing such change to Specifications, and any costs and expenses incurred by the JMCTris in connection therewith. (c) The Company If any proposed change in Specifications is in response to a pronouncement of the FDA, a change in controlling compendial monograph, an event of Force Majeure, or a change in applicable law, each Party will cooperate with the other in any reasonable manner to effect such change in a timely manner. Alpharma shall be responsible for the cost and expense of implementing such change to Specifications, including any costs and expenses incurred by Tris in connection therewith. Notwithstanding the foregoing, if the proposed change to the Specifications is due to a deficiency that is substantially and directly caused by Tris or substantially and directly related to the Tris Technology, then Tris shall be responsible for the cost and expense of implementing such change to Specifications, including any costs and expenses incurred by Alpharma in connection therewith. (d) If any such change pursuant to this Section 8.5.3 will result in an increase in production costs to Tris, Tris shall be entitled to reflect such increase in the Commercial Transfer Price. Alpharma shall be responsible for, and bear all incremental cost incurred by Tris of, any changes in Product or (to the extent applicable) **** labeling, packaging, package inserts, quality control and assurance activities, testing, or validation required by the applicable Regulatory Authorities in the Territory. In the event that any change to Specifications is implemented, the Parties agree to cooperate with each other in good faith to enable each Party to comply with the terms of this Agreement. 8.5.4 Tris shall conduct, or cause to be conducted, quality control testing of API the Product and Anti-caking Complex prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time (collectively, the "Testing Methods")Specifications. Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company shall undertake all such tests. The Company Tris or its designee shall retain records pertaining to such testing, batch records and records otherwise required by any Regulatory Authority in connection with the manufacture, storage or shipping of the Product or Anti-caking Complex for the period required by any Regulatory Authority in any country in the Territory. **** Each shipment of API hereunder Product and Anti-caking Complex shall be accompanied by a certified quality control protocol copy of all in-process and certificate of analysis finished product test results for each lot of API therein the API, Anti-caking Complex and Product, as well as all documentation regarding deviations and investigations resulting from such customs testing and/or batch processing, except for that which is part of Tris' **** DMF or other information deemed proprietary to Tris; provided, however, *****. After **** years from the First Commercial Sale, the Parties shall review and other documentation as is necessary or appropriatedecide what documents are to be eliminated from all such documents that are burdensome. (d) ERS 8.5.5 Tris shall annually make available to Alpharma copies of stability data for the Product and Anti-caking Complex. Any significant trends shall be promptly reported to Alpharma in writing. 8.5.6 For so long as Tris is manufacturing Products or Anti-caking Complex under the Commercial Supply Agreement, Alpharma shall have the right, at reasonable times its sole cost and expense, during normal business hours and upon reasonable ten (10) days' prior notice, to have a duly authorized representative conduct compliance inspections or other inspections, audits and investigations to ensure that Tris' handling, manufacture, testing, storage and shipping of the Products or Anti-caking Complex comply with cGMP, all applicable laws and the Specifications; provided, however, that such inspection, audit or investigation shall not unreasonably interfere with the operations at Tris' facilities and shall not occur more than once per Calendar Year unless Section 8.5.7 applies. In all cases, such Alpharma representatives shall fully comply with Tris' procedures in Tris' facility including procedures adopted for the purpose of protecting the confidential information and/or manufacturing processes of Third Parties from observation by Alpharma's representatives. 8.5.7 If two (2) or more shipments per calendar year of Product and/or Anti-caking Complex are finally determined to be rejectionable, in whole or in part, by Alpharma in accordance with Section 8.6, Alpharma shall be entitled to inspect all the facilities at which API is such Product and/or Anti-caking Complex are manufactured pursuant not more than once each calendar quarter during the continuation of such manufacturing problem and such inspection shall be in addition to this the annual inspection provided for in Section 8 for compliance with cGMP8.5.6; provided, subject however, that ****. Tris shall permit representatives of any Regulatory Authority to existing agreements with Third Party Manufacturers. (e) All units gain access to Tris facilities, books and records as may be necessary or required. Tris shall notify Alpharma as soon as Tris becomes aware of Finished Product manufactured pursuant to this Agreement will comply in all material respects with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations any proposed inspection relating to the manufactureProduct and/or Anti-caking Complex, sale permit Alpharma to have a representative present at said inspection and shipment promptly provide Alpharma with copies of each Finished Product at the time it is manufactured and distributed hereunderany reports or observations made by such Regulatory Authorities, which shall be redacted to omit any confidential or proprietary information of Tris. ****. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testing.

Conformity; Specifications; Quality Control. (a) All quantities of API supplied by the Company pursuant to this Section 8 will comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API at the time it is shipped by the Company hereunder. (b) Changes to the Specifications shall be made only by the JMC. (c) The Company shall conduct, or cause to be conducted, quality control testing of API prior to shipment, in accordance with the Specifications and applicable Manufacturing Standards as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time (collectively, the "Testing MethodsTESTING METHODS"). Initially and until decided otherwise by the JMC, the Testing Methods shall include all FDA required release testing and the Company shall undertake all such tests. The Company shall retain records pertaining to such testing. Each shipment of API hereunder shall be accompanied by a certified quality control protocol and certificate of analysis for each lot of API therein as well as such customs and other documentation as is necessary or appropriate. (d) ERS shall have the right, at reasonable times and upon reasonable notice, to inspect all facilities at which API is manufactured pursuant to this Section 8 for compliance with cGMP, subject to existing agreements with Third Party Manufacturers. (e) All units of Finished Product manufactured pursuant to this Agreement will comply in all material respects with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each Finished Product at the time it is manufactured and distributed hereunder. (f) The Party responsible for processing the API into Finished Products (either ERS or the Company to the extent that the Company is responsible for processing API into Finished Products pursuant to Section 8.1(b)) shall conduct, or cause to be conducted, quality control testing of each Finished Product prior to shipment, in accordance with the applicable Manufacturing Standards and specifications for Finished Products determined by the JMC, as are in effect from time to time and such other quality control testing procedures adopted by the JMC from time to time. Such Party shall retain records pertaining to such testing.