Post-Approval Studies Sample Clauses

Post-Approval Studies. (a) UCB agrees to [*] for the Product in the Development Indication from the FDA so that the FDA [*] the Product in the Development Indication [*] of the Product for use in the Development Indication. To the extent the FDA requires a Paediatric Plan to be undertaken as a condition for the Regulatory Approval of the Product in the Development Indication, such Paediatric Plan shall be included within the Development Plan. (b) If the EMA requires a Paediatric Plan to be undertaken as a condition for Regulatory Approval of the Product for the Development Indication by the EMA, such Paediatric Plan shall be included within the Development Plan. (c) If the Development activities to be conducted under the Development Plan to satisfy the requirements of the FDA and EMA for the Regulatory Approval of the Product in the Development Indication, including any Paediatric Plan and/or other Post-Approval Studies, are not sufficient to satisfy the requirements of Health Canada for the Regulatory Approval of the Product in the Development Indication (the “Health Canada Additional Requirement”), Dermira shall have the right to terminate its rights and obligations under this Agreement with respect to Canada by providing written notification to UCB within sixty (60) Business Days after learning about such Health Canada Additional Requirement, whereupon: (A) Canada shall no longer be included in the Promotion Territory, (B) all of Dermira’s obligations with respect to the Product in Canada shall terminate, and (C) any costs and expenses incurred in connection with any Development activities to be conducted by or on behalf of UCB thereafter for the purpose of obtaining Regulatory Approval from Health Canada shall be solely borne by UCB. In the event there exists no Health Canada Additional Requirement, or if Dermira does not provide UCB with such written notification of termination as set forth in the preceding sentence, then: (X) Canada shall remain included in the Promotion Territory, (Y) to the extent there exists any Health Canada Additional Requirement, the Development Plan (together with the JDC-Approved Development Budget therein) shall be modified to include the Development activities that would satisfy such Health Canada Additional Requirement; and (Z) the Development Costs in connection therewith shall be deemed to be included in the FDA/EMA Development Costs, provided that Dermira’s share of such Development Costs, as incurred, shall be counted towards the Cap. (d) T...
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Post-Approval Studies. Xxxxxx shall be responsible for, and shall bear all expenses related to, any post-Marketing Approval studies (including Phase 4 Clinical Trials) required by individual countries in the Licensed Territory for the Licensed Product. Xxxxxx shall bear all costs and expenses related to the establishment of any safety registry mandated as part of Marketing Approvals in the Licensed Territory.
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Post-Approval Studies. Licensee shall be responsible for conducting any post-Regulatory Approval studies of Product (i) that are required by the FDA in the Licensee Territory (“FDA-Required Studies”) or (ii) that Licensee determines to conduct with respect to the Product in the Field in the Licensee Territory. Any and all such post-Regulatory Approval studies shall be conducted by Licensee as its sole expense. Licensee shall not be under any obligation to conduct any such additional post-Regulatory Approval studies of Product (other than the FDA-Required Studies).
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Post-Approval Studies. Post-Approval Studies shall mean those studies and activities subsequent to the granting of a Regulatory Approval that are required or necessary for the maintenance of such Regulatory Approval.
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Post-Approval Studies. VIVUS shall be responsible for conducting any post-Regulatory Approval studies of Product that are required by the FDA in the Auxilium Territory (“FDA-Required Studies”). The costs of conducting any FDA-Required Studies shall be borne by the Parties equally, up to a maximum aggregate payment by Auxilium of [**], and once this maximum is reached, VIVUS shall be solely responsible for the remainder of such costs. VIVUS shall conduct such studies using Commercially Reasonable Efforts. Any additional post-Regulatory Approval studies of Product that Auxilium determines to conduct with respect to the Product in the Field in the Auxilium Territory shall be conducted by Auxilium as its sole expense. Auxilium shall not be under any obligation to conduct any such additional post-Regulatory Approval studies of Product.
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Post-Approval Studies. Sanofi shall be responsible, at Sanofi’s sole expense, for conducting any clinical or non-clinical studies of Product that are required by any of the individual countries in the Sanofi Territory, whether such studies are conducted prior to or after receipt of the Sanofi Territory Approvals. Sanofi shall conduct such studies using Commercially Reasonable Efforts.
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Post-Approval Studies. Where requirements to conduct post-Regulatory Approval studies are imposed by a Regulatory Authority in the Menarini Territory (including the Post-Marketing Requirements, but excluding the QT Study), whether imposed on VIVUS as the initial holder of the Product Marketing Authorization or on Menarini as the subsequent holder of the Product Marketing Authorization, Menarini shall be responsible for conducting such post-Regulatory Approval studies of Product. VIVUS shall pay for *** percent (***%) of the costs of conducting any such post-Regulatory Approval studies. Notwithstanding the foregoing, if and when VIVUS’s actual aggregate payments under the preceding sentence exceed *** Euros (€***), VIVUS shall have the right to forego any further ***, in which case Menarini shall be solely responsible for any further costs of conducting such post-Regulatory Approval studies, subject to its termination right described in the following sentence. For clarity, if the EMA or the European Commission requires any post-Regulatory Approval studies under the Existing MAA that were not included in the opinion adopted by the EMA’s Committee for Medicinal Products for Human Use and the Product Marketing Authorization or if the QT Study results into any change of the SmPC of Product which would reasonably have a negative impact on the Commercialization of the Product in the Territory, Menarini shall have the right to terminate this Agreement at its sole discretion pursuant to Section 12.2(c).
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Post-Approval Studies. After the POCD EIR Product receives Initial U.S. Marketing Approval, Alfa shall transfer the IND back to Salix, and Salix shall manage and control (at its sole cost and expense) any post-approval marketing studies, as agreed and directed by the Steering Committee.
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Post-Approval Studies. In the event the FDA requires a Phase IV study, BPA shall conduct such study but shall only be responsible for XXX% of the fully burdened cost and expense of any Phase IV commitment up to a maximum of $XXXXXX, with Company responsible for the excess. BPA shall from time to time invoice Company for Company’s share of such costs and expenses, and Company shall pay such invoices within thirty (30) days of receipt.
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Related to Post-Approval Studies

  • New Project Approval Consultant and District recognize that Consultant’s Services may include working on various projects for District. Consultant shall obtain the approval of District prior to the commencement of a new project.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • Project Approval The County may issue a Job Order Authorization for the Work, to include the firm-fixed-price of the Job Order and the project duration. Contractor agrees that all clauses of this Contract are applicable to any Job Order issued hereunder. The County reserves the right to reject a Contractor’s Quote based on unjustifiable quantities and/or methods, performance periods, inadequate documentation, or other inconsistencies or deficiencies on the Contractor’s part in the sole opinion of the County. The County reserves the right to issue a unilateral Job Order authorization for the Work if a Quote price cannot be mutually agreed upon. This is based upon unjustifiable quantities in the sole opinion of the County. The County also reserves the right to not issue a Job Order Authorization if the County’s requirement is no longer valid or the project is not funded. In these instances, the Contractor has no right of claim to recover Quote expenses. The County may pursue continuing valid requirements by other means where Contract was not reached with the Contractor.

  • 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.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Final Approval Hearing “Final Approval Hearing” shall mean the hearing at which the Court will consider and finally decide whether to enter the Final Judgment.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Waiver of Notice; Approval of Meeting; Approval of Minutes The transactions of any meeting of Limited Partners, however called and noticed, and whenever held, shall be as valid as if it had occurred at a meeting duly held after regular call and notice, if a quorum is present either in person or by proxy. Attendance of a Limited Partner at a meeting shall constitute a waiver of notice of the meeting, except when the Limited Partner attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened; and except that attendance at a meeting is not a waiver of any right to disapprove the consideration of matters required to be included in the notice of the meeting, but not so included, if the disapproval is expressly made at the meeting.

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