No Interference But No Consent For FDA Approval Sample Clauses

No Interference But No Consent For FDA Approval. Depomed and Santarus shall not, and shall not cause any Affiliate or Third Party to: (a) initiate any activity (including but not limited to the filing of any citizen petitions or litigation against the FDA) to interfere with or obstruct Lupin’s efforts to (i) obtain FDA approval of the Lupin ANDA, or (ii) launch Lupin’s ANDA Products as of the date and under the terms provided by this Agreement; and/or (b) unless required by law, (i) delist or cancel the Depomed Products or NDA No. 21-748 with the FDA, (ii) delist or remove any Depomed Patents, or the Depomed Products or NDA 21-748, from the FDA’s Orange Book, (iii) seek or otherwise undertake any action with the FDA to withdraw the Depomed Products from the market, or (iv) delete, remove, designate as “obsolete” or cancel any National Drug Code(s) or any other relevant code(s) for the Depomed Products from the applicable National Drug Data File maintained by First Databank (or any successor or equivalent organization), or from any other pricing database. Neither this Agreement nor this Section shall be interpreted as Depomed’s or Santarus’ consent to approval from the FDA or any other applicable regulatory authority for Lupin to market a product containing metformin in the Territory. As Lupin may reasonably request, Depomed and Santarus will submit, or will cause their Affiliates to submit, appropriate and reasonable documentation to the FDA evidencing this Agreement. Notwithstanding the above, this Section does not preclude Depomed, Santarus and/or their Affiliates from taking any action necessary or commencing a Proceeding to secure or maintain their statutory rights under 21 U.S.C. §355a.
Sample 1Sample 2
AutoNDA by SimpleDocs
No Interference But No Consent For FDA Approval. Subject to Defendants’ compliance with the terms of this Agreement and excluding any actions based on reasonable safety or efficacy concerns or required by law, Plaintiff shall not, after the Dismissal Effective Date, (a) delete, remove or cancel the Cubist NDA or any National Drug Codes or any other relevant codes for the Cubist Product from the National Drug Data File maintained by First Databank for the Territory, or from any other pricing database in the Territory, as long as Defendants and their Affiliates continue to sell the Teva ANDA Product in the Territory; or (b) take any action before the FDA to prevent the manufacture, use, sale or offering for sale of the Teva ANDA Product in the Territory, or importation of the Teva ANDA Product into the Territory, as of the ANDA License Start Date. Nothing in this Agreement shall be interpreted as Plaintiff’s consenting to approval from the FDA or any other applicable regulatory authority for Defendants to manufacture, use, sell or offer to sell the Teva ANDA Product in the Territory, or to import the Teva ANDA Product into the Territory, except as expressly provided herein.
Sample 1
No Interference But No Consent For FDA Approval. Subject to Xxxxxxx’x compliance with the terms of this Agreement and the License Agreement, and excluding any safety or efficacy concerns relating to the generic product defined by the Xxxxxxx XXXX, Schering shall not initiate any activity directly against the generic product defined by the Xxxxxxx XXXX to interfere with Xxxxxxx’x efforts to: (a) obtain FDA approval of the Xxxxxxx XXXX; or (b) launch the generic product that is the subject of the Xxxxxxx XXXX as of the date and under the terms provided by the License Agreement. Neither this Agreement nor this section shall be interpreted as Schering consenting to approval from the FDA or any other applicable regulatory authority for Xxxxxxx to market a product incorporating desloratadine in the Territory.
Sample 1
No Interference But No Consent For FDA Approval. Except in relation to public policy or safety, Alexion and its Affiliates shall not initiate or undertake, or cause or release any others to initiate or undertake, any activity directed against the Amgen Eculizumab Products or any BLA or aBLA relating to the Amgen Eculizumab Products, to interfere or seek to interfere with Amgen’s, its Affiliates’, or an Amgen Partner’s efforts to: (a) carve out any information or indication from the label for the Amgen Eculizumab Products; (b) obtain FDA approval of any BLA or aBLA relating to the Amgen Eculizumab Products; (c) launch and sell the Amgen Eculizumab Products pursuant to the terms of this Settlement Agreement; or (d) maintain FDA approval of any BLA or aBLA relating to the Amgen Eculizumab Products. Nothing in this Settlement Agreement shall be interpreted as Alexion or any of its Affiliates consenting to the accuracy or sufficiency of any scientific, medical, regulatory, or other information contained in any BLA or aBLA relating to the Amgen Eculizumab Products.
Sample 1

Related to No Interference But No Consent For FDA Approval

  • No Consent The execution, delivery and performance by the Assignor of this Assignment Agreement and the consummation of the transactions contemplated hereby do not require the consent or approval of, the giving of notice to, the registration with, or the taking of any other action in respect of, any state, federal or other governmental authority or agency, except such as has been obtained, given, effected or taken prior to the date hereof.

  • No Consents or Approvals None of the execution, delivery or performance by Purchaser of this Agreement, or the other Transfer Documents, or the consummation by Purchaser of the transactions contemplated hereby and thereby, requires the consent or approval of, the giving of notice to, the registration, recording or filing of any documents with, or the taking of any other action in respect of, any Governmental Authority, except such as have been obtained or effected on or prior to the applicable Closing Date.

  • No Consents The Servicer is not required to obtain the consent of any other party or any consent, license, approval or authorization, or registration or declaration with, any governmental authority, bureau or agency in connection with the execution, delivery, performance, validity or enforceability of this Agreement which has not already been obtained.

  • Governmental Authorization; Third Party Consents No approval, consent, compliance, exemption, authorization or other action by, or notice to, or filing with, any Governmental Authority or any other Person, and no lapse of a waiting period under any Requirement of Law, is necessary or required in connection with the execution, delivery or performance (including, without limitation, the purchase of the Purchased Shares) by, or enforcement against, such Purchaser of this Agreement or the transactions contemplated hereby.

  • Corporate and Governmental Authorization; No Contravention The Borrower’s incurrence of Debt hereunder, and the execution, delivery and performance by the Borrower of this Agreement and the Notes, are within the corporate powers of the Borrower, have been duly authorized by all necessary corporate action, require no action by or in respect of, or filing with, any Governmental Authority (except such as has been obtained), do not contravene, or constitute a default under, any provision of applicable law or regulation or of the certificate of incorporation or by-laws of the Borrower or of any agreement, judgment, injunction, order, decree or other instrument binding upon the Borrower or any of its Subsidiaries, or result in the creation or imposition of any Lien on any asset of the Borrower or any of its Subsidiaries.

  • Certification Regarding Prohibition of Boycotting Israel (Tex Gov. Code 2271)

  • Notice of a License Action Grantee shall notify their contract manager of any action impacting its license to provide services under this Contract within five days of becoming aware of the action and include the following: a. Reason for such action; b. Name and contact information of the local, state or federal department or agency or entity; x. Xxxx of the license action; and d. License or case reference number.

  • No Consents, Etc Neither the respective businesses or properties of the Borrower or any Subsidiary, nor any relationship among the Borrower or any Subsidiary and any other Person, nor any circumstance in connection with the execution, delivery and performance of the Loan Documents and the transactions contemplated thereby, is such as to require a consent, approval or authorization of, or filing, registration or qualification with, any Governmental Authority or any other Person on the part of the Borrower as a condition to the execution, delivery and performance of, or consummation of the transactions contemplated by the Loan Documents, which, if not obtained or effected, would be reasonably likely to have a Material Adverse Effect, or if so, such consent, approval, authorization, filing, registration or qualification has been duly obtained or effected, as the case may be.

  • No Governmental Approvals Required Except as previously obtained or made, no authorization, consent, approval, order, license or permit from, or filing, registration or qualification with, any Governmental Agency is or will be required to authorize or permit under applicable Laws the execution and delivery by Borrower of the Loan Documents to which it is a Party and payment of the Obligations.

  • Governmental Approvals and Filings Except for any notices required or permitted to be filed after the Closing Date with certain federal and state securities commissions, the Company shall have obtained all governmental approvals required in connection with the lawful sale and issuance of the Notes.

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