Transfer of IND and Other Regulatory Information Sample Clauses

Transfer of IND and Other Regulatory Information. Licensor shall transfer to Licensee the IND for Licensor’s V134444 product. Within [***] after the Effective Date, Licensor will initiate transfer of such IND (as outlined in 21 C.F.R. § 314.72) to Licensee. Licensor agrees to send a letter(s) to the FDA to transfer such IND to Licensee, and Licensee in turn will notify the FDA that it accepts the transfer. Each Party agrees to provide the other with a copy of their respective letters of transfer. Upon transfer, Licensee will be the IND sponsor and will be responsible for all reporting and other duties of a sponsor in accordance with applicable law. As soon as reasonably practicable but not later than [***] after the Effective Date, Licensor will transfer to Licensee copies (in electronic or other format) of any regulatory information, safety and clinical databases of tabulated data and all other regulatory materials prepared or created by Licensor or its Affiliates related solely and exclusively to Compounds or any Licensed Product.
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Related to Transfer of IND and Other Regulatory Information

  • Regulatory and Other Authorizations Each party hereto shall use its commercially reasonable efforts to obtain all authorizations, consents, orders and approvals of any Governmental Authority that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to, this Agreement and will cooperate fully with the other party in promptly seeking to obtain all such authorizations, consents, orders and approvals.

  • Field Audit, Examination Reports and other Information; Disclaimer by Lenders By signing this Agreement, each Lender:

  • Regulatory and Other Approvals Purchaser will (a) take all reasonable steps necessary or desirable, and proceed diligently and in good faith and use all reasonable efforts, at the earliest commercially practicable dates, to obtain all consents, approvals or actions of, to make all filings with and to give all notices to Governmental or Regulatory Authorities or any other Person required of Purchaser to consummate the transactions contemplated hereby and by the Operative Agreements, including those described in Section 3.03 of the Disclosure Schedule and Purchaser Required Regulatory Approvals or for Purchaser to own, operate or maintain, on and after the Closing, the Assets substantially as such assets are currently owned, operated and maintained by Seller, (b) provide such other information and communications to such Governmental or Regulatory Authorities or other Persons as such Governmental or Regulatory Authorities or other Persons may reasonably request in connection therewith and (c) provide reasonable cooperation to Seller in obtaining Seller Required Regulatory Approvals and all other consents, approvals or actions of, making all filings with and giving all notices to Governmental or Regulatory Authorities or other Persons required of Seller to consummate the transactions contemplated hereby and by the Operative Agreements. Prior to making any filings with a Governmental or Regulatory Authority pursuant to this Section 5.01, Purchaser agrees to provide copies of such filings to Seller. Nothing in this Agreement shall require Purchaser to institute litigation or to pay or agree to pay any sum of money or make financial accommodations (other than the payment or incurrence of customary expenses and filing or other fees) in order to obtain any necessary consent, approval or authorization including, without limitation, the Purchaser Required Regulatory Approvals. Purchaser will provide prompt notification to Seller when any such consent, approval, action, filing or notice referred to in clause (a) above is obtained, taken, made or given, as applicable, and will advise Seller of any communications (and, unless precluded by Law, provide copies of any such communications that are in writing) with any Governmental or Regulatory Authority or other Person regarding any of the transactions contemplated by this Agreement or any of the Operative Agreements.

  • Financial Reports and Other Information (a) The Borrower will maintain a system of accounting in accordance with GAAP and will furnish to the Lenders and their respective duly authorized representatives such information respecting the business and financial condition of the Borrower and its Subsidiaries as any Lender may reasonably request. The Borrower shall deliver (via email or otherwise) to the Administrative Agent in form and detail satisfactory to the Administrative Agent, with copies for each Lender in form and substance satisfactory to them, each of the following:

  • Provision of Information Necessary for Preparation of Securities Registration Statements, Amendments and Other Materials The Manager, its officers and employees will make available and provide accounting and statistical information required by the Fund in the preparation of registration statements, reports and other documents required by federal and state securities laws and with such information as the Fund may reasonably request for use in the preparation of such documents or of other materials necessary or helpful for the underwriting and distribution of the Fund’s shares.

  • Regulatory and Other Authorizations; Consents (a) Each party hereto shall use all commercially reasonable efforts to obtain all authorizations, consents, orders and approvals of, and to give all notices to and make all filings with, all Governmental Entities (including but not limited to those pertaining to the Governmental Approvals) and other third parties that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to this Agreement and will cooperate fully with the other party in promptly seeking to obtain all such authorizations, consents, orders and approvals, giving such notices, and making such filings. To the extent required by the HSR Act, each of the parties hereto shall (i) file or cause to be filed, as promptly as practicable but in no event later than 15 days after (x) the execution and delivery of this Agreement or (y) such later date as a change of circumstances causes such a filing to be required, with the Federal Trade Commission and the United States Department of Justice, all reports and other documents required to be filed by such party under the HSR Act concerning the transactions contemplated hereby and (ii) promptly comply with or cause to be complied with any requests by the Federal Trade Commission or the United States Department of Justice for additional information concerning such transactions, in each case so that the waiting period applicable to this Agreement and the transactions contemplated hereby under the HSR Act shall expire as soon as practicable after the execution and delivery of this Agreement. Each party hereto agrees to request, and to cooperate with the other party or parties in requesting, early termination of any applicable waiting period under the HSR Act. Savia shall pay the filing fees payable in connection with the filings by the parties required by the HSR Act.

  • Government and Other Regulations This Option is subject to all laws, regulations and orders of any governmental authority which may be applicable thereto and, notwithstanding any of the provisions hereof, the Holder agrees that the Holder will not exercise the Option granted hereby nor will the Company be obligated to issue or sell any shares of stock hereunder if the exercise thereof or the issuance or sale of such shares, as the case may be, would constitute a violation by the Holder or the Company of any such law, regulation or order or any provision thereof. The Company shall not be obligated to take any affirmative action in order to cause the exercise of this Option or the issuance or sale of shares pursuant hereto to comply with any such law, regulation, order or provision.

  • Record Keeping and Other Information FIIOC and FSC shall create and maintain all records required by all applicable laws, rules and regulations relating to the services to be performed herein, including but not limited to, all applicable records required by Section 31(a) of the 1940 Act and the rules thereunder, as the same may be amended from time to time. All records shall be the property of the Trust and shall be available for inspection and use by the Trust at all times. Where applicable, such records shall be maintained by FIIOC and FSC for the periods and in the places required by Rule 31a-2 under the 1940 Act, with respect to FIIOC, and by rules under the 1940 Act, with respect to FSC.

  • Pollution and Other Regulations Each of the Credit Parties:

  • Regulatory and Other Authorizations; Notices and Consents (a) Each party shall, and shall cause its Affiliates to, use its reasonable best efforts to (i) promptly obtain all authorizations, consents, orders and approvals of all Governmental Authorities that may be or become necessary in connection with the Stock Purchase; (ii) cooperate fully with each other in promptly seeking to obtain all such authorizations, consents, orders and approvals; and (iii) provide such other information to any Governmental Authority as such Governmental Authority may reasonably request in connection herewith. Each party hereto shall, and shall cause its respective Affiliates to, make promptly its respective filing, if necessary, pursuant to the HSR Act with respect to the transactions contemplated by this Agreement. Acquiror shall, with the reasonable assistance of the Company, the Seller Guarantors and the Sellers, make as promptly as practicable any filings and notifications, if any, under any other applicable Antitrust Law and each party shall supply as promptly as practicable to the appropriate Governmental Authorities any additional information and documentary material that may be reasonably requested pursuant to applicable Antitrust Law. Each of Acquiror, on the one hand, and the Seller Guarantors, the Sellers, NewCo and the Company, on the other hand, acknowledges and agrees that it shall pay and shall be solely responsible for the payment of 50% of all filing fees associated with such filings (in the case of the Seller Guarantors, the Sellers, NewCo and the Company, such amounts shall be Transaction Expenses).

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