Common use of Assumption that Pre-Market Approval Not Required Clause in Contracts

Assumption that Pre-Market Approval Not Required. The Initial R&D Plan has been prepared and the initial R&D Payments have been determined on the assumption that the First Female Product will be a 510(k) Product and not a PMA Product. In the event that the First Female Product is determined by the FDA to be a PMA Product, Xxxxxxxx may elect to terminate this Agreement in accordance with Section 10.4(b), or elect to continue participating in such development and commercialization for such product. In the event that Xxxxxxxx elects to continue participating in such development and commercialization, the parties shall cooperate in good faith to agree upon a revised R&D Plan and additional R&D Payments required to implement and carry out such revised plan, provided that, subject to Xxxxxxxx’x right to credit certain amounts pursuant to the proviso in this sentence, Xxxxxxxx shall be solely responsible for any incremental Costs of Palomar and Xxxxxxxx, and shall pay Palomar additional R&D Payments in an amount equal to Palomar’s incremental Costs, which result from or relate to classification of such product as a PMA Product; provided, however, that fifty percent (50%) of the total amount of such incremental Costs, not to exceed in the aggregate two million five hundred thousand dollars ($2,500,000), are creditable by Xxxxxxxx against the First Development Completion Payment only (and no other payments owed by Xxxxxxxx to Palomar hereunder), if any, owed by Xxxxxxxx to Palomar. Following the adoption by the parties of such revised R&D Plan, the parties shall cooperate in good faith to implement and carry out the R&D Activities set out in such R&D Plan.

Assumption that Pre-Market Approval Not Required. The Initial R&D Plan has been prepared and the initial R&D Payments have been determined on the assumption that the First Female Product will be a 510(k) Product and not a PMA Product. In the event that the First Female Product is determined by the FDA to be a PMA Product, Xxxxxxxx Gxxxxxxx may elect to terminate this Agreement in accordance with Section 10.4(b), or elect to continue participating in such development and commercialization for such product. In the event that Xxxxxxxx Gxxxxxxx elects to continue participating in such development and commercialization, the parties shall cooperate in good faith to agree upon a revised R&D Plan and additional R&D Payments required to implement and carry out such revised plan, provided that, subject to Xxxxxxxx’x Gxxxxxxx’x right to credit certain amounts pursuant to the proviso in this sentence, Xxxxxxxx Gxxxxxxx shall be solely responsible for any incremental Costs of Palomar and XxxxxxxxGxxxxxxx, and shall pay Palomar additional R&D Payments in an amount equal to Palomar’s incremental Costs, which result from or relate to classification of such product as a PMA Product; provided, however, that fifty percent (50%) of the total amount of such incremental Costs, not to exceed in the aggregate two million five hundred thousand dollars ($2,500,000), are creditable by Xxxxxxxx Gxxxxxxx against the First Development Completion Payment only (and no other payments owed by Xxxxxxxx Gxxxxxxx to Palomar hereunder), if any, owed by Xxxxxxxx Gxxxxxxx to Palomar. Following the adoption by the parties of such revised R&D Plan, the parties shall cooperate in good faith to implement and carry out the R&D Activities set out in such R&D Plan.

Assumption that Pre-Market Approval Not Required. The Initial R&D Plan has been prepared and the initial R&D Payments have been determined on the assumption that the First Female Product will be a 510(k) Product and not a PMA Product. In the event that the First Female Product is determined by the FDA to be a PMA Product, Xxxxxxxx may elect to terminate this Agreement in accordance with Section 10.4(b), or elect to continue participating in such development and commercialization for such product. In the event that Xxxxxxxx elects to continue participating in such development and commercialization, the parties shall cooperate in good faith to agree upon a revised R&D Plan and additional R&D Payments required to implement and carry out such revised plan, provided that, subject to Xxxxxxxx’x right to credit certain amounts pursuant to the proviso in this sentence, Xxxxxxxx shall be solely responsible for any incremental Costs of Palomar and Xxxxxxxx, and shall pay Palomar additional R&D Payments in an amount equal to Palomar’s incremental Costs, which result from or relate to classification of such product as a PMA Product; provided, however, that fifty percent (50%) of the total amount of such incremental Costs, not to exceed in the aggregate two million five hundred thousand dollars ($2,500,000), are creditable by Xxxxxxxx against the First Development Completion Payment only (and no other payments owed by Xxxxxxxx to Palomar hereunder), if any, owed by Xxxxxxxx to Palomar. Following the adoption by the parties of such revised R&D Plan, the parties shall cooperate in good faith to implement and carry out the R&D Activities set out in such R&D Plan.. 1.7