Transfer of Governmental Filings and Authorizations Sample Clauses

Transfer of Governmental Filings and Authorizations. Incline will use its best efforts to assume each of the IND, NDA and MAA as soon as possible after the Closing and ALZA shall cooperate with Incline to effectuate such transfer by using reasonable efforts to: (1) provide Incline with available information within ALZA's Control; and/or (2) communicate as necessary with the Regulatory Authority responsible for the IND, NDA and MAA, including providing documentation controlled by ALZA in its sole discretion (which ALZA may direct Incline to prepare) and required by such Regulatory Authority to effect such transfer. Incline shall deliver evidence of its assumption of the IND and NDA to the FDA within one business day of receipt of confirmation from ALZA that it has delivered evidence of its assignment of the IND and NDA to the FDA. If, despite ALZA's reasonable cooperation, the IND or NDA or both are not assigned to Incline and the obligations thereunder are not assumed by Incline by September 1, 2010, Incline shall incur a penalty fee of $[**] on such day, and the first day of each subsequent month thereafter that such filings and obligations are not assigned and assumed. ALZA shall have no obligation following December 31, 2010 to continue to maintain the IND or NDA and may after such date take any and all actions to terminate such filings. If, despite ALZA's reasonable cooperation, the MAA is not assigned to Incline and the obligations thereunder are not assumed by Incline by January 1, 2011, Incline shall incur a penalty fee of $[**] on such day, and the first day of each subsequent month thereafter that such filings and obligations are not assigned and assumed. ALZA shall have no obligation following April 30, 2011 to continue to maintain the MAA and may after such date take any and all actions to terminate such filings. In addition to the foregoing and notwithstanding anything herein to the contrary, ALZA's cooperation shall not include responsibility for any operational activities such as those related to product development or supply chain that may be required to effect transfer and ALZA shall not have any Liability or be responsible for any Damages related to ALZA's maintenance of the IND, NDA or MAA prior to the assumption of such filings by Incline or for the inability of such filings to be transferred to Incline.
Sample 1
AutoNDA by SimpleDocs

Related to Transfer of Governmental Filings and Authorizations

  • Governmental Authorizations; Private Authorizations; Governmental Filings The Borrower has obtained, maintained and kept in full force and effect all Governmental Authorizations and Private Authorizations which are necessary for it to properly carry out its business, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, and made all material Governmental Filings necessary for the execution and delivery by it of the Facility Documents to which it is a party, the Borrowings by the Borrower under this Agreement, the pledge of the Collateral by the Borrower under this Agreement and the performance by the Borrower of its obligations under this Agreement, the other Facility Documents, and no material Governmental Authorization, Private Authorization or Governmental Filing which has not been obtained or made, is required to be obtained or made by it in connection with the execution and delivery by it of any Facility Document to which it is a party, the Borrowings by the Borrower under this Agreement, the pledge of the Collateral by the Borrower under this Agreement or the performance of its obligations under this Agreement and the other Facility Documents to which it is a party.

  • Filings and Authorizations (a) The Parties will, as promptly as practicable but in any event within 20 days of the date of this Agreement (unless otherwise mutually agreed), make, or cause to be made, all filings and applications with, and give all notices and submissions to, Governmental Authorities that are necessary for the lawful completion of the Contemplated Transactions contemplated by this Agreement, including (i) the Purchaser and the Seller filing with the Commissioner a notification under Part IX of the Competition Act; (ii) the Purchaser filing an application for TSX Approval with the TSX; and (iii) the Purchaser filing a written submission concerning the competitive effects of the Contemplated Transactions and requesting that the Commissioner issue an ARC. (b) The Purchaser will use its commercially reasonable efforts to obtain TSX Approval and the Purchaser and the Seller will use their commercially reasonable efforts to obtain the Competition Act Approval and each Party will promptly co-operate with and assist the other Party in preparing the submissions referenced in Section 5.5(a) and all other filings or responses to questions or requests from the Commissioner, Governmental Authorities or the TSX. Without limiting the generality of the foregoing, in the event that either, or both, of the Purchaser and the Seller receive a supplementary information request pursuant to subsection 114(2) of the Competition Act (a “SIR”), or an order to produce records, make a written return of information, and/or have one or more employees attend an oral examination conducted by the Commissioner (collectively, a “Section 11 Order”), in connection with the Contemplated Transactions, the Purchaser and/or the Seller, as applicable, shall use its respective commercially reasonable efforts to respond to the SIR or Section 11 Order at the earliest practicable date. For purposes of this provision, the Purchaser and/or the Seller, as applicable, shall be deemed to have responded to any such SIR or Section 11 Order by providing a response that it in good faith believes to be in compliance with the terms of the SIR or Section 11 Order and by certifying such compliance pursuant to section 118 of the Competition Act or in accordance with the SIR or Section 11 Order. In the event that the Commissioner disputes the adequacy of compliance by the Purchaser and/or the Seller, as applicable, with respect to a SIR or Section 11 Order, the Purchaser and/or the Seller, as applicable, shall endeavour to satisfy the Commissioner as soon as possible so as to minimize any delay in the conduct or resolution of the Commissioner’s review of the Contemplated Transactions. (c) Neither Party will provide any substantive oral nor written representations, statements, information, remedy proposals or other filings to the Commissioner without first giving the other a reasonable opportunity to provide its comments, and each Party will consider such comments in good faith before providing any such representations, statements, information or other filings to the Commissioner. (d) Subject to compliance at all times with Applicable Law and the other provisions of this Agreement and to information being competitively sensitive, the Purchaser and Seller will coordinate and cooperate in exchanging information and supplying assistance that is reasonably requested by the other in connection with this

  • Required Authorizations There is no requirement to make any filing with, give any notice to, or obtain any Authorization of, any Governmental Entity as a condition to the lawful completion of the transactions contemplated by this Agreement.

  • Licenses, Permits and Authorizations The related Mortgagor has represented in the related Mortgage Loan documents that, and to the actual knowledge of the Seller, as of the date of origination of such Mortgage Loan, all material licenses, permits and authorizations then required for use of the related Mortgaged Property by such Mortgagor, the related lessee, franchisor or operator have been issued and were valid and in full force and effect.

  • Consents and Authorizations Each Credit Party shall have obtained all consents and authorizations from Governmental Authorities and all consents of other Persons (including shareholder approvals, if applicable) that are necessary or advisable in connection with this Agreement, any Loan Document, any of the transactions contemplated hereby or thereby or the continuing operations of the Credit Parties and each of the foregoing shall be in full force and effect and in form and substance satisfactory to the Initial Lender.

  • Authorization of Governmental Authorities No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Agreement, subject to, in the case of the Debtors, the entry by the Bankruptcy Court of the Approval Order.

  • Permits and Authorizations Each of the Company and its subsidiaries possesses all material Environmental Permits (as defined below) necessary to conduct its businesses and operations as now being conducted.

  • Consents and Requisite Governmental Approvals; No Violations (a) No consent, approval or authorization of, or designation, declaration or filing with, any Governmental Entity is required on the part of a Parent Party with respect to such Parent Party’s execution, delivery or performance of its obligations under this Agreement or the Ancillary Documents to which it is or will be party or the consummation of the transactions contemplated by this Agreement or by the Ancillary Documents, except for (i) the filing with the SEC of (A) the Registration Statement / Proxy Statement and the declaration of the effectiveness thereof by the SEC and (B) such reports under Section 13(a), 15(d) or 16 of the Exchange Act as may be required in connection with this Agreement, the Ancillary Documents or the transactions contemplated hereby or thereby, (ii) such filings with and approvals of Nasdaq to permit the Parent Common Stock to be issued in connection with the transactions contemplated by this Agreement and the other Ancillary Documents to be listed on Nasdaq, (iii) filing of the Certificates of Merger, (iv) the approvals and consents to be obtained by each Merger Sub pursuant to Section 5.9, or (v) the Parent Stockholder Approval. (b) Subject to the receipt of the Consents, approvals, authorizations and other requirements set forth in Section 4.3(a), neither the execution, delivery or performance by a Parent Party of this Agreement nor the Ancillary Documents to which a Parent Party is or will be a party nor the consummation by a Parent Party of the transactions contemplated hereby or thereby will, directly or indirectly (with or without due notice or lapse of time or both) (i) result in any breach of any provision of the Governing Documents of a Parent Party, (ii) result in a violation or breach of, or constitute a default or give rise to any right of termination, cancellation, amendment, modification, suspension, revocation or acceleration under, any of the terms, conditions or provisions of any Contract to which a Parent Party is a party, (iii) violate, or constitute a breach under, any Order or applicable Law to which any such Parent Party or any of its properties or assets are bound or (iv) result in the creation of any Lien upon any of the assets or properties (other than any Permitted Liens) of a Parent Party, except, in the case of any of clauses (ii) through (iv) above, as would not, individually or in the aggregate, reasonably be expected to be material or prevent, materially delay or materially impair the ability of a Parent Party to consummate the Transactions.

  • Authorizations and Approvals Each Borrower shall promptly obtain, from time to time at its own expense, all such Governmental Approvals as may be required to enable such Borrower to comply with its obligations, under the Loan Documents and its Constituent Documents, and to conduct its business in the customary fashion.

  • Governmental Filings and Consents All material governmental filings, consents, orders and approvals legally required to be filed or made by the Company for the consummation of the transactions contemplated hereby shall have been made or obtained and shall be in full force and effect.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!