FDA Cooperation Sample Clauses

FDA Cooperation. Customer shall own all documents related to the Products filed by Supplier with the FDA and Customer shall be entitled to make reference to all documents related to the Products and filed by Supplier with the FDA. Supplier shall not make use of any Specifications or FDA filings related to the Products except in connection with its performance under this Agreement. The provisions of this Section 8.4 shall survive the termination or expiration of this Agreement.
Sample 1
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FDA Cooperation. As Licensees may reasonably request, Horizon USA will submit, and will cause their respective Affiliates to submit, appropriate and reasonable documentation to the FDA evidencing the licenses set forth in this License Agreement to assist Par and its Affiliates in obtaining and maintaining FDA approval for Par’s Generic Tablets, at Par’s sole cost and expense. Par shall reimburse Horizon USA for all reasonable out-of-pocket costs and expenses incurred by Horizon USA and/or its Affiliates in performing activities under this Paragraph 7, within thirty (30) days after receipt of an invoice therefor from Horizon USA.
Sample 1
FDA Cooperation. Licensors and their Affiliates hereby waive, with respect to the Actavis ANDA and Actavis Generic Tablets only, any and all regulatory exclusivities for Xxxxx® that may prevent approval or marketing of the Actavis Generic Tablets in the Territory under the Actavis ANDA as of the Generic Entry Date. To the extent that FDA has granted any regulatory exclusivities or otherwise prevents approval or launch of the Actavis Generic Tablets, Licensors and their Affiliates agree to reasonably cooperate with Actavis and the FDA to gain final approval of the Actavis Generic Tablets. By way of example only, at Licensees’ request, Horizon Pharma Switzerland and Jagotec will submit, or will cause their respective Affiliates to submit, appropriate and reasonable documentation to the FDA evidencing the waivers and licenses set forth in this Agreement. Licensees shall reimburse Horizon Pharma Switzerland and Jagotec for all reasonable costs and expenses incurred by them and/or their Affiliates in seeking Third Party advice and/or assistance in performing activities under this Paragraph 8, within […***…] days after receipt of an invoice therefor, provided such invoice is accompanied by documents from such Third Party verifying such Third Party charges to Horizon Pharma Switzerland and/or Jagotec.
Sample 1
FDA Cooperation. (a) Within five (5) business days of Impax’s request, Endo shall provide the FDA with written confirmation of the Commencement Date and the license, covenants and waivers herein, including, where applicable, written confirmation that the Commencement Date is before January 1, 2013, and including, where applicable, written confirmation that the restriction specified in the Stipulation of Dismissal and Order does not bar entry by Impax on a date prior to January 1, 2013. Concurrently with such request, Impax shall provide to Endo the desired form of written confirmation to be provided to the FDA.
Sample 1

Related to FDA Cooperation

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Tax Cooperation The Parties agree to use commercially reasonable efforts to cooperate with one another and use commercially reasonable efforts to avoid or reduce, to the extent permitted by Applicable Laws, Tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by the paying Party to the receiving Party under this Agreement (“Withholding Taxes”). If Withholding Taxes are imposed on any payment under this Agreement, the liability for such Withholding Taxes shall be the sole responsibility of the receiving Party, and the paying Party shall (i) deduct or withhold such Withholding Taxes from the payment made to the receiving Party, (ii) timely pay such Withholding Taxes to the proper taxing authority, and (iii) send proof of payment to the receiving Party within thirty (30) days following such payment. If and to the extent the paying Party failed to retain Withholding Taxes (e.g. because the Parties assumed that Withholding Taxes will not be imposed) or if Withholding Taxes are imposed on “deemed payments” the receiving Party shall reimburse the paying Party for any Withholding Tax obligation vis-à-vis the tax authorities. Each Party shall comply with (or provide the other Party with) any certification, identification or other reporting requirements that may be reasonably necessary in order for the paying Party to not withhold Withholding Taxes or to withhold Withholding Taxes at a reduced rate under an applicable bilateral income tax treaty. Each Party shall provide the other with commercially reasonable assistance to enable the recovery, as permitted by Applicable Laws, of Withholding Taxes or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing the cost of such Withholding Taxes under this Section 16.5(d) (Tax Cooperation). Notwithstanding the foregoing, if as a result of any assignment or sublicense by the paying Party, any change in the paying Party’s tax residency, any change in the entity that originates the payment, or any failure on the part of the paying Party to comply with Applicable Laws with respect to Withholding Taxes (including filing or record retention requirements), Withholding Taxes are imposed that would not otherwise have been imposed (“Incremental Withholding Taxes”), then the paying Party shall be solely responsible for the amount of such Incremental Withholding Taxes and shall increase the amounts payable to the receiving Party so that the receiving Party receives a sum equal to the sum which it would have received had there been no such imposition of Incremental Withholding Taxes. If a Party makes a payment in accordance with the sentence above (gross-up) (“Tax Payment”) and

  • Information/Cooperation Executive shall, upon reasonable notice, furnish such information and assistance to the Bank as may be reasonably required by the Bank, in connection with any litigation in which it or any of its subsidiaries or affiliates is, or may become, a party; provided, however, that Executive shall not be required to provide information or assistance with respect to any litigation between Executive and the Bank or any other subsidiaries or affiliates.

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Scope of Cooperation 1) Party A authorizes Party B as the sole distribution agent of the “Case edition” and “Channel edition” of China Marketing and China Business and Trade in the territory of Hunan Province (not including post offices) and Party B is responsible for the distribution matter within such area. Party A will support Party B to achieve a good performance in the regional marketing and promotion and guarantee the legitimate rights and interests of Party B during the term of this agreement.

  • Assistance and Cooperation After the Closing Date, each of Seller and Purchaser shall:

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • Litigation Cooperation From the date hereof and continuing through the termination of this Agreement, make available to Bank, without expense to Bank, Borrower and its officers, employees and agents and Borrower’s books and records, to the extent that Bank may deem them reasonably necessary to prosecute or defend any third-party suit or proceeding instituted by or against Bank with respect to any Collateral or relating to Borrower.

  • No Cooperation Executive agrees that he will not counsel or assist any attorneys or their clients in the presentation or prosecution of any disputes, differences, grievances, claims, charges, or complaints by any third party against the Company and/or any officer, director, employee, agent, representative, shareholder or attorney of the Company, unless under a subpoena or other court order to do so.

  • General Cooperation (a) The Parties shall each cooperate fully (and each shall cause its respective Subsidiaries to cooperate fully) with all reasonable requests in writing (“Information Request”) from another Party hereto, or from an agent, representative or advisor to such Party, in connection with the preparation and filing of Tax Returns (including the preparation of Tax Packages), claims for Refunds, Tax Proceedings, and calculations of amounts required to be paid pursuant to this Agreement, in each case, related or attributable to or arising in connection with Taxes of any of the Parties or their respective Subsidiaries covered by this Agreement and the establishment of any reserve required in connection with any financial reporting (a “Tax Matter”). Such cooperation shall include the provision of any information reasonably necessary or helpful in connection with a Tax Matter (“Information”) and shall include, without limitation, at each Party’s own cost:

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