Common use of Launch Indication Approval Clause in Contracts

Launch Indication Approval. BPA shall use its commercially reasonable efforts for the good faith prosecution of its pending NDA for Bio-E-Gel for the Launch Indication; provided, BPA’s commercially reasonably efforts shall include, at a minimum, performing all regulatory and clinical work for FDA Approval in the United States of Product for the Launch Indication (except for changes arising out of non-FDA required marketing, packaging, or manufacturing changes) at its sole expense not to exceed a fully burdened cost of $XXXXXX. After the Effective Date, Company will have the right to participate in all formal meetings with the FDA regarding such FDA Approval. BPA agrees to provide Company with copies of all correspondence and documents to and from FDA and all notices received from FDA and to also provide Company with regular updates as Company may reasonably request. If further or additional regulatory work and clinical studies are required by the FDA in order to obtain such FDA Approval and the fully burdened cost to BPA will exceed $XXXXXX, Company shall have the option, but not the obligation, to fund the excess. If Company declines to fund the excess, and if BPA also declines to fund the excess, then either party shall be permitted to terminate this Agreement and such termination will be deemed not to be caused by the breach of either party and will be deemed not to be a termination by Company under Section 16(d). In the event of termination under this Section 5(a), BPA agrees to refund to Company the $3,500,000 initial payment paid by Company to BPA pursuant to Section 3(a)(ii)(1), less any amount actually paid by Company to Antares on account of such initial payment under the Prime License Agreement; provided, however, BPA shall use its commercially reasonable efforts to obtain a refund of any portion of sub-licensee payments paid to Antares under the Prime License Agreement, and shall promptly pay over to Company any such amounts recovered from or credited by Antares.

Launch Indication Approval. BPA shall use its commercially reasonable efforts for the good faith prosecution of its pending NDA for Bio-E-Gel for the Launch Indication; provided, BPA’s commercially reasonably efforts shall include, at a minimum, performing all regulatory and clinical work for FDA Approval in the United States of Product for the Launch Indication (except for changes arising out of non-FDA required marketing, packaging, or manufacturing changes) at its sole expense not to exceed a fully burdened cost of $XXXXXX. After the Effective Date, Company will have the right to participate in all formal meetings with the FDA regarding such FDA Approval. BPA agrees to provide Company with copies of all correspondence and documents to and from FDA and all notices received from FDA and to also provide Company with regular updates as Company may reasonably request. If further or additional regulatory work and clinical studies are required by the FDA in order to obtain such FDA Approval and the fully burdened cost to BPA will exceed $XXXXXX, Company shall [PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIALITY UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. A COPY OF THIS EXHIBIT WITH ALL SECTIONS INTACT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] have the option, but not the obligation, to fund the excess. If Company declines to fund the excess, and if BPA also declines to fund the excess, then either party shall be permitted to terminate this Agreement and such termination will be deemed not to be caused by the breach of either party and will be deemed not to be a termination by Company under Section 16(d). In the event of termination under this Section 5(a), BPA agrees to refund to Company the $3,500,000 initial payment paid by Company to BPA pursuant to Section 3(a)(ii)(1), less any amount actually paid by Company to Antares on account of such initial payment under the Prime License Agreement; provided, however, BPA shall use its commercially reasonable efforts to obtain a refund of any portion of sub-licensee payments paid to Antares under the Prime License Agreement, and shall promptly pay over to Company any such amounts recovered from or credited by Antares.

Launch Indication Approval. BPA shall use its commercially reasonable efforts for the good faith prosecution of its pending NDA for Bio-E-Gel for the Launch Indication; provided, BPA’s commercially reasonably efforts shall include, at a minimum, performing all regulatory and clinical work for FDA Approval in the United States of Product for the Launch Indication (except for changes arising out of non-FDA required marketing, packaging, or EXECUTION VERSION manufacturing changes) at its sole expense not to exceed a fully burdened cost of $XXXXXX[***]. After the Effective Date, Company will have the right to participate in all formal meetings with the FDA regarding such FDA Approval. BPA agrees to provide Company with copies of all correspondence and documents to and from FDA and all notices received from FDA and to also provide Company with regular updates as Company may reasonably request. If further or additional regulatory work and clinical studies are required by the FDA in order to obtain such FDA Approval and the fully burdened cost to BPA will exceed $XXXXXX[***], Company shall have the option, but not the obligation, to fund the excess. If Company declines to fund the excess, and if BPA also declines to fund the excess, then either party shall be permitted to terminate this Agreement and such termination will be deemed not to be caused by the breach of either party and will be deemed not to be a termination by Company under Section 16(d). In the event of termination under this Section 5(a), BPA agrees to refund to Company the $3,500,000 initial payment paid by Company to BPA pursuant to Section 3(a)(ii)(1), less any amount actually paid by Company to Antares on account of such initial payment under the Prime License Agreement; provided, however, BPA shall use its commercially reasonable efforts to obtain a refund of any portion of sub-licensee payments paid to Antares under the Prime License Agreement, and shall promptly pay over to Company any such amounts recovered from or credited by Antares.