Common use of Production Procedures Clause in Contracts

Production Procedures. 6.1 Supplier shall not rework or reprocess any non-conforming Products without the prior written approval of Novartis. Notwithstanding the foregoing, Supplier may correct minor packaging defects observed prior to the completion of production of a batch of Products without the prior written approval of Novartis. Supplier shall describe any such corrections in the applicable batch records. 6.2 The Products shall be delivered to Novartis packaged in accordance with the Specifications. Notwithstanding the foregoing, Novartis shall have the right to require any special or varied packing that it believes is reasonably necessary to meet customs or regulatory requirements. Reasonable incremental costs which result directly from any packing changes required by Novartis will be borne by Novartis. 6.3 At least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to its first production run of Products, and prior to the production of qualification batches, Supplier shall provide to Novartis written notice thereof. Supplier and Novartis shall then agree upon a schedule for the review and approval by Novartis of Supplier's production procedures for the Products, including without limitation the manufacturing site, manufacturing equipment, manufacturing process, manufacturing conditions or testing procedures within its facilities for the manufacture of the Products (collectively, the "Production Procedures"). After such initial Novartis approval, if Supplier should wish to change any of the Production Procedures, Supplier shall provide written notice of such proposed changes to Novartis at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to implementation. Supplier and Novartis shall then agree upon a schedule for the review and approval by Novartis of such changes, which must be approved in writing by Novartis prior to being implemented, which approval shall not unreasonably be withheld. 6.4 In the event that regulatory action or applicable law require changes in the Specifications or any production procedures, then, subject to Novartis' prior written agreement, Supplier shall use its commercially reasonable best efforts to implement such changes as soon as reasonably practicable. Should such regulatory action or applicable law only require changes to the Products and not to any other products manufactured by Supplier, then Novartis shall pay the reasonable costs actually incurred by Supplier in implementing such changes. In all other events, the parties shall enter into good faith negotiations to allocate the costs of any such changes between them. 6.5 Supplier represents and warrants, and shall take all actions reasonably necessary to ensure, that all facilities, equipment and practices used to perform its responsibilities under this Agreement by or on behalf of Supplier, or any of Supplier's environmental or safety and health consultants or waste management or disposal contractors (collectively, the "Supplier Contractors"), will be during the term of this Agreement, in full compliance with all health, safety and environmental laws, statutes, ordinances, regulations, rules, permits and pronouncements. 6.5.1 Supplier assumes responsibility for disposing of any and all waste generated during the performance of its responsibilities under this Agreement (including, without limitation, during any manufacturing, storage and transportation activities) in accordance with all legal and professional standards. 6.5.2 Notwithstanding anything to the contrary herein, (i) should Supplier and/or any Supplier Contractor fail to comply with the obligations set forth in this Section 6.5, then Supplier shall be solely responsible for any claims, suits, or liabilities resulting therefrom (including, without limitation, those based on strict liability and joint and several liability), and Supplier shall indemnify, defend and save Novartis (including officers, directors, employees and agents of Novartis) harmless from and against any and all such claims, suits, and liabilities; and

Production Procedures. 6.1 Supplier shall not rework or reprocess any non-conforming Licensed Products without the prior written approval of Novartis. Notwithstanding the foregoing, Supplier may correct minor packaging defects observed prior to the completion of production of a batch of Products without the prior written approval of Novartis. Supplier shall describe any such corrections in the applicable batch recordsNCH. 6.2 The Licensed Products shall be delivered to Novartis NCH packaged in accordance with the Specifications. Notwithstanding the foregoing, Novartis NCH shall have the right to require any special or varied packing that it believes is reasonably necessary to meet customs or regulatory requirements. Reasonable incremental costs which result directly from any packing changes required by Novartis NCH will be borne by NovartisNCH. 6.3 At least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] ninety (90) days prior to its first production run of Licensed Products, and at some mutually agreeable time prior to the production of qualification batches, Supplier shall provide to Novartis written notice thereof. Supplier and Novartis shall then agree upon a schedule NCH, for the its review and approval by Novartis of Supplier's approval, its production procedures for the Licensed Products, including without limitation the manufacturing site, manufacturing equipment, manufacturing process, manufacturing conditions or testing procedures within its facilities for the manufacture of the Licensed Products (collectively, the "Production Procedures"). After such initial Novartis NCH approval, if Supplier should wish to change any of the Production ProceduresProcedures which might affect the quality of the Licensed Products furnished to NCH hereunder, Supplier shall provide written notice of such proposed changes to Novartis NCH at least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] sixty (60) days prior to implementation. Supplier and Novartis shall then agree upon a schedule for the review and approval by Novartis of All such changes, which changes must be approved in writing by Novartis NCH prior to being implemented, which approval shall not unreasonably be withheld. 6.4 In the event that regulatory action or applicable law require changes in the Specifications or any production procedures, then, subject to Novartis' NCH's prior written agreement, Supplier shall use its commercially reasonable best efforts to implement such changes as soon as reasonably practicable. Should such regulatory action or applicable law only require changes to the Products and not to any other products manufactured by Supplier, then Novartis shall pay the reasonable costs actually incurred by Supplier in implementing such changes. In all other events, the The parties shall enter into in good faith negotiations to allocate the costs of any such changes between them. 6.5 Supplier represents and warrants, and shall take all actions reasonably necessary to ensure, that all facilities, equipment and practices used to perform its responsibilities under this Agreement by or on behalf of Supplier, or any of Supplier's contractors of any rank (including, without limitation, environmental or safety and health consultants or waste management or disposal contractors firms) (collectively, the "Supplier Contractors"), will be during the term of this Agreement, in full compliance with all health, safety and environmental laws, statutes, ordinances, regulations, rules, permits and pronouncements. 6.5.1 . Supplier assumes responsibility for disposing of any and all waste generated during the performance of its responsibilities under this Agreement (including, without limitation, during any manufacturing, storage and transportation activities) in accordance with all legal and professional standards. 6.5.2 . Notwithstanding anything to the contrary herein, (i) should Supplier and/or any Supplier Contractor fail to comply with the obligations set forth in this Section 6.5, then Supplier shall be solely responsible for any claims, suits, or liabilities resulting therefrom (including, without limitation, those based on strict liability and joint and several liability), and Supplier shall indemnify, defend and save Novartis NCH (including all officers, directors, employees employees, Affiliates and agents of NovartisNCH) harmless from and against any and all such claims, suits, and liabilities; and