Patheon’s Responsibility for Defective Clause Samples
Patheon’s Responsibility for Defective and Recalled Products 17 6.4 Disposition of Defective or Recalled Products 18 6.5 Healthcare Provider or Patient Questions and Complaints 18 6.6 Sole Remedy 18 7.1 Quarterly Review 19 7.2 Governmental Agencies 19 7.3 Records and Accounting by Patheon 19 7.4 Inspection 19 7.5 Access 19 7.6 Notification of Regulatory Inspections 20 7.7 Reports 20 7.8 FDA Filings 20 8.1 Initial Term 21 8.2 Termination for Cause 21 8.3 Product Discontinuation 22 8.4 Obligations on Termination 22 9.1 Authority 23 9.2 Client Warranties 23 9.3 Patheon Warranties 24 9.4 Debarred Persons 25 9.5 Permits 25 9.6 No Warranty 25 10.1 Consequential Damages 25 10.2 Limitation of Liability 25 10.3 Patheon 26 10.4 Client 26 10.5 Reasonable Allocation of Risk 26
Patheon’s Responsibility for Defective and Recalled Products 16 6.4 Disposition of Defective or Recalled Products 17 6.5 Healthcare Provider or Patient Questions and Complaints 17 6.6 Sole Remedy 18 7.1 Quarterly Review 18 7.2 Governmental Agencies 18 7.3 Records and Accounting by Patheon 18 7.4 Inspection 19 7.5 Access 19 7.6 Notification of Regulatory Inspections 19 7.7 Reports 19 7.8 FDA Filings 19 8.1 Term 20 8.2 Termination for Cause 21 8.3 Product Discontinuation 21 8.4 Obligations on Termination 21 9.1 Authority 22 9.2 PGx Warranties 22 9.3 Patheon Warranties 23 9.4 Debarred Persons 23 9.5 Permits 23 9.6 No Warranty 24 10.1 Consequential Damages 24 10.2 Limitation of Liability 24 10.3 Patheon 24 10.4 PGx 25 10.5 Reasonable Allocation of Risk 25 11.1 Confidentiality 25 12.1 Commercial Disputes 25 12.2 Technical Dispute Resolution 26 13.1 Inventions 26 13.2 Intellectual Property 27 13.3 Insurance 27 13.4 Independent Contractors 27 13.5 No Waiver 28 13.6 Assignment 28 13.7 Force Majeure 28 13.8 Additional Product 28 13.9 Notices 29 13.10 Severability 29 13.11 Entire Agreement 30 13.12 Other Terms 30 13.13 No Third Party Benefit or Right 30 13.14 Execution in Counterparts 30 13.15 Use of PGx Name 30 13.16 Governing Law 30 THIS COMMERCIAL MANUFACTURING SERVICES AGREEMENT (this “Agreement”) is made as of August 18, 2010 (the “Effective Date”) B E T W E E N: PATHEON PUERTO RICO, INC., a corporation existing under the laws of the Commonwealth of Puerto Rico PATHEON PHARMACEUTICALS INC., a corporation existing under the laws of the State of Delaware (collectively “Patheon”), a limited liability company existing under the laws of the State of Delaware (“PGx”). THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to be legally bound the parties (Patheon and PGx) agree as follows: