APPROVAL OBTAINED definition

APPROVAL OBTAINED means, with respect to a product or process, that the sale of such product or process or its use in the FIELD in any country has been licensed, cleared or approved by all applicable regulatory or other governmental authority in such country, including the Food and Drug Administration (“FDA”) with respect to products or processes sold in the UNITED STATES.
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Examples of APPROVAL OBTAINED in a sentence

  • Prior to the date of APPROVAL OBTAINED of any LICENSED LTC T CELL PRODUCTS ADAPTIMMUNE shall submit four (4) copies of an annual MINIMUM ANNUAL ROYALTY report and MILESTONE EVENT report to LTC twelve (12) months from the EFFECTIVE DATE until the date of first APPROVAL OBTAINED of any LICENSED LTC T CELL PRODUCTS.

  • Prior to the date of APPROVAL OBTAINED of any LICENSED T CELL PRODUCTS ADAPTIMMUNE shall submit four (4) copies of an annual MINIMUM ANNUAL ROYALTY report and MILESTONE EVENT report to LTC twelve (12) months from the EFFECTIVE DATE until the date of first APPROVAL OBTAINED of any LICENSED T CELL PRODUCTS.

  • SELLER HAS MADE NO REPRESENTATION THAT ANY PERMIT OR OTHER APPROVAL OBTAINED OR TO BE OBTAINED BY SELLER IS NOT SUBJECT TO REVERSAL BY REASON OF CHALLENGES THERETO BY PRIVATE PARTIES OR GOVERNMENT OR OTHER ENTITIES OR AGENCIES AND BUYER SPECIFICALLY ASSUMES THE RISK OF SUCH AN OCCURRENCE.

  • LICENSEE ACKNOWLEDGES AND AGREES THAT AXSOME MAKES AND HAS MADE NO REPRESENTATION OR WARRANTY THAT THE LICENSED PRODUCTS CAN BE SUCCESSFULLY DEVELOPED FOR ANY ADDITIONAL INDICATION OR THAT LICENSED PRODUCTS CAN BE SUCCESSFULLY COMMERCIALIZED IN ANY COUNTRY OF THE TERRITORY FOR THE INDICATIONS INCLUDED IN THE TRANSFERRED REGUALTORY APPROVALS OR FOR ANY ADDITIONAL INDICATION THAT IS INCLUDED IN ANY REGULATORY APPROVAL OBTAINED BY LICENSEE.

Related to APPROVAL OBTAINED

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • CFIUS Approval means (i) the Company and the applicable Purchaser(s) shall have received written notice from CFIUS that review under Section 721 of the Defense Production Act of 1950 as amended by the Foreign Investment Risk Review Modernization Act of 2018, including implementing regulations thereof, 31 C.F.R. Parts 800 and 802 (the “DPA”), of the transactions contemplated hereby has been concluded, and CFIUS shall have determined that there are no unresolved national security concerns with respect to the transactions contemplated hereby, and advised that action under Section 721 of the DPA, and any investigation related thereto, has been concluded with respect to the transactions contemplated hereby; (ii) CFIUS shall have concluded that the transactions contemplated hereby are not covered transactions and are not subject to review under Section 721 of the DPA; or (iii) CFIUS shall have sent a report to the President of the United States (the “President”) requesting the President’s decision on the notice and either (1) the period under Section 721 of the DPA during which the President may announce his decision to take action to suspend or prohibit the transactions contemplated hereby shall have expired without any such action being announced or taken or (2) the President shall have announced a decision not to take any action to suspend or prohibit the transactions contemplated hereby.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.