Common use of Responsibility for Regulatory Filings Clause in Contracts

Responsibility for Regulatory Filings. Each Party shall be responsible, [***], for filing, obtaining and maintaining approvals for those activities assigned to such Party hereunder in connection with the Development, manufacture and Commercialization of Products for the Field in the Territory. The Parties acknowledge that, as between the Parties, Cephalon shall have the sole right and responsibility for filing any MAA or Marketing Approval, as well as pricing or reimbursement approvals for the Products for the Field in the Territory and maintaining the same. All activities under this Section 4.6(b) shall be done subject to the oversight and in full consultation with the JSC. Prior to the filing any MAA for a Product in the Field in the Territory, Cephalon shall provide a copy thereof to the JSC for its review and approval (including any associated proposed labeling).

Responsibility for Regulatory Filings. Each Party shall be responsible, [***]at its expense, for filing, obtaining and maintaining approvals for those activities assigned to such Party hereunder in connection with the Development, manufacture and Commercialization of Products for the Field in the Territory. The Parties acknowledge that, as between the Parties, Cephalon shall have the sole right and responsibility for filing any MAA or Marketing Approval, as well as pricing or reimbursement approvals for the Products for the Field in the Territory and maintaining the same. All activities under this Section 4.6(b) shall be done subject to the oversight and in full consultation with the JSC. Prior to the filing any MAA for a Product in the Field in the Territory, Cephalon shall provide a copy thereof to the JSC for its review and approval (including any associated proposed labeling).

Responsibility for Regulatory Filings. Each Party shall be responsible, [***], for filing, obtaining and maintaining approvals for those activities assigned to such Party hereunder in connection with the Development, manufacture and Commercialization of Products for the Field in the Territory. The Parties acknowledge that, as between the Parties, Cephalon shall have the sole right and responsibility for filing any MAA or Marketing Approval, as well as pricing or reimbursement approvals for the Products for the Field in the Territory and maintaining the same. All activities under this Section 4.6(b) shall be done subject to the oversight and in full consultation with the JSC. Prior to the filing any MAA for a Product in the Field in the Territory, Cephalon shall provide a copy thereof to the JSC for its review and approval (including any associated proposed labeling).