Registrations, Listings, Authorizations and Approvals Sample Clauses

Registrations, Listings, Authorizations and Approvals. (a) Labeled Drug. Corixa or its designee shall be responsible for obtaining and maintaining such drug licenses, registrations, listings, authorizations and approvals as the FDA or any other applicable governmental entity may require to enable use of Labeled Drug in Clinical Trials and marketing of Labeled Drug wherever such activities will occur. Nordion shall, to the extent it has information in it possession, provide assistance to Corixa in obtaining and maintaining all licenses, registrations, listings, authorizations and approvals of any governmental entities necessary for the use of Labeled Drug in Clinical Trials and marketing of Labeled Drug wherever such activities will occur. Corixa and/or its designee shall serve as the point of contact with the FDA and any other applicable governmental entity concerning licenses, registration, authorizations or approvals required to use Labeled Drug in Clinical Trials or market Labeled Drug, but may, as appropriate, request Nordion's assistance with the FDA and/or other applicable governmental entity communications. (b) Drug Master Files. Nordion shall, at Nordion's expense, update its Isotope Drug Master File with the FDA ("DMF"), as may be required for the chemistry, manufacture and control ("CMC") section for the IND or BLA for the Labeled Drug, or corresponding portions of any submission for a license, registration, authorization or approval required by other applicable governmental entities in the Territory for Clinical Trials or for marketing Labeled Drug ("Territory DMF").. Upon Corixa's request, and subject to Nordion's prior review and approval of the submission that references the DMF or Territory DMF, which approval shall not be unreasonably withheld or delayed, Nordion shall grant to Corixa a right of reference to such DMF or Territory DMF and shall provide Corixa: (i) A letter of access to the DMF and the Territory DMF allowing regulatory review of the DMF and the Territory DMF by the FDA, Health Canada or equivalent agency in the Territory in conjunction with Corixa's Labeled Drug regulatory submission; and (ii) Any information related to the Process required for CMC purposes or for comparable purposes in the Territory. In the event that Nordion is contacted by the FDA, Health Canada or equivalent agency in the Territory regarding the DMF or Territory DMF to the extent it has an impact on Labeled Drug, Nordion shall promptly provide Corixa with notice of such contact and provide written confirmatio...
Sample 1Sample 2
AutoNDA by SimpleDocs

Related to Registrations, Listings, Authorizations and Approvals

  • 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.

  • Filings and Approvals Cooperate with the other in the preparation and filing, as soon as practicable, of (A) the Applications, (B) the Proxy Statement, (C) all other documents necessary to obtain any other approvals, consents, waivers and authorizations required to effect the completion of the Merger and the other transactions contemplated by this Agreement, and (D) all other documents contemplated by this Agreement;

  • Authorization and Approvals No authorization or approval or other action by, and no notice to or filing with, any Governmental Authority is required for the due execution, delivery and performance by the Borrower, the Parent, or any Guarantor of the Credit Documents to which it is a party or the consummation of the transactions contemplated thereby. At the time of each Borrowing, no authorization or approval or other action by, and no notice to or filing with, any Governmental Authority will be required for such Borrowing or the use of the proceeds of such Borrowing the absence of which could reasonably be expected to cause a Material Adverse Change.

  • Filings, Consents and Approvals The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company of the Transaction Documents, other than: (i) the filings required pursuant to Section 4.4 of this Agreement, (ii) the filing with the Commission of the Prospectus Supplement, (iii) application(s) to each applicable Trading Market for the listing of the Shares and Warrant Shares for trading thereon in the time and manner required thereby and (iv) such filings as are required to be made under applicable state securities laws (collectively, the “Required Approvals”).

  • LICENSES; CERTIFICATIONS; AUTHORIZATIONS; & APPROVALS Contractor represents and warrants that Contractor possesses and shall keep current during the term of this Contract all required licenses, certifications, permits, authorizations, and approvals necessary for Contractor’s proper performance of this Contract.

  • 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.

  • Regulatory Consents and Approvals All consents, approvals and actions of, filings with and notices to any Governmental or Regulatory Authority necessary to permit Purchaser and Seller to perform their obligations under this Agreement and the Operative Agreements and to consummate the transactions contemplated hereby and thereby (a) shall have been duly obtained, made or given, (b) shall be in form and substance reasonably satisfactory to Purchaser, (c) shall not be subject to the satisfaction of any condition that has not been satisfied or waived and (d) shall be in full force and effect, and all terminations or expirations of waiting periods imposed by any Governmental or Regulatory Authority necessary for the consummation of the transactions contemplated by this Agreement and the Operative Agreements shall have occurred.

  • Authorizations and Consents No authorization, consent, approval, exemption, franchise, permit or license of, or filing with, any governmental or public authority or any third party is required to authorize, or is otherwise required in connection with the valid execution and delivery by the Borrower of this Agreement, the Notes, and the Security Instruments, or any other instrument contemplated hereby, the repayment by the Borrower of advances against the Notes and interest and fees provided in the Notes and this Agreement, or the performance by the Borrower of its obligations under any of the foregoing.

  • Authorization; Approvals The issuance of the Policy and the execution, delivery and performance of this Agreement and the Insurance Agreement have been duly authorized by all necessary corporate proceedings. No further approvals or filings of any kind, including, without limitation, any further approvals of or further filings with any governmental agency or other governmental authority, or any approval of the Insurer’s board of directors or stockholders, are necessary for the Policy, this Agreement and the Insurance Agreement to constitute the legal, valid and binding obligations of the Insurer.

  • Governmental Authorizations and Consents Each Credit Party shall have obtained all Governmental Authorizations and all consents of other Persons, in each case that are necessary or advisable in connection with the transactions contemplated by the Credit Documents and each of the foregoing shall be in full force and effect and in form and substance reasonably satisfactory to Administrative Agent. All applicable waiting periods shall have expired without any action being taken or threatened by any competent authority which would restrain, prevent or otherwise impose adverse conditions on the transactions contemplated by the Credit Documents or the financing thereof and no action, request for stay, petition for review or rehearing, reconsideration, or appeal with respect to any of the foregoing shall be pending, and the time for any applicable agency to take action to set aside its consent on its own motion shall have expired.

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