Common use of Development and Registration Responsibilities Clause in Contracts

Development and Registration Responsibilities. 3.1.1 Prior to the Effective Date IMPAX has performed the following development and registration activities: (i) designed, conducted and met all bioequivalency test requirements for Regulatory Approval by FDA in accordance with FDA guidance documents; (ii) designed and conducted all dosage form, formulation, process, and chemistry manufacturing and control ("CMC") and related technical studies on Products, including preparation of dosage form CMC regulatory documents required for FDA review and approval of the Products; and (iii) FDA acceptance for filing of ANDA No. 76-050 and ANDA No. 75-989 with FDA seeking approval of the D-12 Product and D-24 Product, respectively, as generic prescription drugs and is prepared for FDA's pre-approved inspection. 3.1.2 At WCH's request, IMPAX shall supplement and/or amend ANDA No. 76-050 and ANDA No. 75-989 to include WCH's consumer labeling and packaging and any other documentation necessary or advisable to support WCH's consumer labeling and packaging for the OTC Field for the Products. IMPAX shall, at its expense, (i) complete the construction, installation, commissioning, IQ, OQ and PQ of all Facilities and all equipment necessary for Manufacture of Products and (ii) conduct all scale up and validation activities for FDA approval of Products. 3.1.3 IMPAX shall own and maintain ANDA No. 76-050 and ANDA No. 75-989 and shall use its Commercially Reasonable Efforts to pursue, and at its expense perform any additional development activities to obtain, final FDA approval of these ANDAs for the OTC Field. WCH may submit applications for Regulatory Approval for Products in the Territory as it deems advisable (including NDAs); provided that WCH shall not be required to make any such submissions for Regulatory Approval unless it determines to do so in its sole discretion. Except for ANDA No. 76-050 and ANDA No. 75-989, WCH shall file, own and maintain all other submissions for Regulatory Approval and Pricing Approval of Products for the OTC Field in the Exclusive Territory. IMPAX shall be responsible for providing the CMC and related technical components of such submissions, as jointly determined by the Parties. Upon WCH's request and at WCH's cost, IMPAX shall use Commercially Reasonable Efforts to provide additional registration batches (including stability and analytical testing) and required documentation to support any NDA that WCH may submit in the United States. WCH shall bear the full cost of any additional studies required for Regulatory Approval of the Products outside of the United States. To the extent that IMPAX undertakes any additional development work which is not required for FDA approval of a Product, at WCH's written request, to support Regulatory Approval in the Territory outside the United States, WCH shall reimburse IMPAX for the Direct Development Cost thereof. 3.1.4 The Parties shall cooperate with, and assist, each other in connection with their activities hereunder including without limitation the protocol for scale up and validation and addressing regulatory questions, and preparing updates and supplements to regulatory filings for Product for the OTC Field in the Territory. IMPAX shall be responsible for all communications with FDA regarding ANDA No. 76-050 and ANDA No. 75-989. WCH shall be responsible for all communications with the FDA and other Regulatory Authorities regarding applications for Regulatory Approval submitted by WCH and post-Regulatory Approval regulatory requirements for Product marketed by WCH for the OTC Field in the Territory, including pharmacovigilance and Adverse Drug Experience reporting, unless otherwise agreed in advance in writing by the Parties. 3.1.5 Each Party represents that it has complied and shall comply with all applicable GLP, GCP and GMP in the conduct of the development activity performed by it for the Products. 3.1.6 Upon WCH's request, IMPAX shall use Commercially Reasonable Efforts to eliminate animal derived materials from the Products and WCH shall reimburse IMPAX for the actual costs incurred by IMPAX (provided that such are approved in writing by WCH prior to being incurred by IMPAX) in connection therewith.

Development and Registration Responsibilities. 3.1.1 Prior to the Effective Date IMPAX has performed the following development and registration activities: (i) designed, conducted and met all bioequivalency test requirements for Regulatory Approval by FDA in accordance with FDA guidance documents; (ii) designed and conducted all dosage form, formulation, process, and chemistry manufacturing and control ("“CMC"”) and related technical studies on Products, including preparation of dosage form CMC regulatory documents required for FDA review and approval of the Products; and (iii) FDA acceptance for filing of ANDA No. 76-050 and ANDA No. 75-989 with FDA seeking approval of the D-12 Product and D-24 Product, respectively, as generic prescription drugs and is prepared for FDA's ’s pre-approved inspection. 3.1.2 At WCH's ’s request, IMPAX shall supplement and/or amend ANDA No. 76-050 and ANDA No. 75-989 to include WCH's ’s consumer labeling and packaging and any other documentation necessary or advisable to support WCH's ’s consumer labeling and packaging for the OTC Field for the Products. IMPAX shall, at its expense, (i) complete the construction, installation, commissioning, IQ, OQ and PQ of all Facilities and all equipment necessary for Manufacture of Products and (ii) conduct all scale up and validation activities for FDA approval of Products. 3.1.3 IMPAX shall own and maintain ANDA No. 76-050 and ANDA No. 75-989 and shall use its Commercially Reasonable Efforts to pursue, and at its expense perform any additional development activities to obtain, final FDA approval of these ANDAs for the OTC Field. WCH may submit applications for Regulatory Approval for Products in the Territory as it deems advisable (including NDAs); provided that WCH shall not be required to make any such submissions for Regulatory Approval unless it determines to do so in its sole discretion. Except for ANDA No. 76-050 and ANDA No. 75-989, WCH shall file, own and maintain all other submissions for Regulatory Approval and Pricing Approval of Products for the OTC Field in the Exclusive Territory. IMPAX shall be responsible for providing the CMC and related technical components of such submissions, as jointly determined by the Parties. Upon WCH's ’s request and at WCH's ’s cost, IMPAX shall use Commercially Reasonable Efforts to provide additional registration batches (including stability and analytical testing) and required documentation to support any NDA that WCH may submit in the United States. WCH shall bear the full cost of any additional studies required for Regulatory Approval of the Products outside of the United States. To the extent that IMPAX undertakes any additional development work which is not required for FDA approval of a Product, at WCH's ’s written request, to support Regulatory Approval in the Territory outside the United States, WCH shall reimburse IMPAX for the Direct Development Cost thereof. 3.1.4 The Parties shall cooperate with, and assist, each other in connection with their activities hereunder including without limitation the protocol for scale up and validation and addressing regulatory questions, and preparing updates and supplements to regulatory filings for Product for the OTC Field in the Territory. IMPAX shall be responsible for all communications with FDA regarding ANDA No. 76-050 and ANDA No. 75-989. WCH shall be responsible for all communications with the FDA and other Regulatory Authorities regarding applications for Regulatory Approval submitted by WCH and post-Regulatory Approval regulatory requirements for Product marketed by WCH for the OTC Field in the Territory, including pharmacovigilance and Adverse Drug Experience reporting, unless otherwise agreed in advance in writing by the Parties. 3.1.5 Each Party represents that it has complied and shall comply with all applicable GLP, GCP and GMP in the conduct of the development activity performed by it for the Products. 3.1.6 Upon WCH's ’s request, IMPAX shall use Commercially Reasonable Efforts to eliminate animal derived materials from the Products and WCH shall reimburse IMPAX for the actual costs incurred by IMPAX (provided that such are approved in writing by WCH prior to being incurred by IMPAX) in connection therewith.