Launch Indication Approval Clause Samples

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.
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Related to Launch Indication Approval

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

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  • Required Regulatory Approvals (a) The obligations of each Party under this Agreement are expressly contingent upon (i) each Party receiving all licenses, permits, permissions, certificates, approvals, authorizations, consents, franchises and releases from any local, state, or federal regulatory agency or other governmental agency or authority (which may include, without limitation and as applicable, the NYISO and the PSC) or any other third party that may be required for such Party in connection with the performance of such Party’s obligations under or in connection with this Agreement (the “Required Approvals”), (ii) each Required Approval being granted without the imposition of any modification or condition of the terms of this Agreement or the subject transactions, unless such modification(s) or condition(s) are agreed to by both Parties in their respective sole discretion, and (iii) all applicable appeal periods with respect to the Required Approvals having expired without any appeal having been made or, if such an appeal has been made, a full, final and non-appealable determination having been made regarding same by a court or other administrative body of competent jurisdiction, which determination disposes of or otherwise resolves such appeal (or appeals) to the satisfaction of both Parties in their respective sole discretion. (b) If any application or request is made in connection with seeking any Required Approval and is denied, or is granted in a form, or subject to conditions, that either Party rejects, in its sole discretion, as unacceptable, this Agreement shall terminate as of the date that a Party notifies the other Party of such denial or rejection, in which event the obligations of the Parties under this Agreement shall cease as of such date and this Agreement shall terminate, subject to NYSEG’s obligation to pay National Grid in accordance with the terms of this Agreement (including, without limitation, Section 10.3 above) for all Reimbursable Costs. All of National Grid’s actual costs in connection with seeking Required Approvals shall be included within the meaning of the term Reimbursable Costs and shall be paid for by NYSEG.

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  • Approval/Non-Approval We will notify you whether your Application has been approved or denied within 14 days after the date we receive a completed Application. Notification may be in person or by mail or telephone unless you have requested that notification be by mail. You must not assume approval until you receive actual notice of approval. The 14-day time period may be changed only by separate written agreement.