U.S. Regulatory Approval definition

U.S. Regulatory Approval means the first achievement of Regulatory Approval of a BLA for a Licensed Product for an Approved Indication.

U.S. Regulatory Approval means with respect to the Licensed Product and a given Indication, Regulatory Approval by the FDA of the Licensed Product, and any required companion diagnostic, for that Indication.

U.S. Regulatory Approval means an approval, license or authorization issued by the U.S. Food and Drug Administration, or any successor agency, required for the commercial manufacture, marketing and sale of Products in the United States in accordance with applicable law.

Examples of U.S. Regulatory Approval in a sentence

• Delay in U.S. Regulatory Approval Significantly Lowers Forecast for BioGenerics Market to $2.3 Billion,” Business Wire, November 22, 2005.

• CPL’s obligation to manufacture Product hereunder shall terminate two years after CryoLife has received U.S. Regulatory Approval (as such term is defined in that certain License Agreement, dated September 28, 2010, by and between CryoLife and SMI) but not beyond 2016 unless with further approval of the parties.

• The development milestone payment set forth in Section 3.2(a)(iii) for U.S. Regulatory Approval of a Licensed Product shall be payable for the first Licensed Product developed by Schering and thereafter shall again be payable for each successive Licensed Product successfully developed by Schering which contains as the active ingredient a different compound from the Compound Library.

• Upon Xxxxxxxx’x request, Palomar shall promptly provide to Xxxxxxxx in writing, with respect to the CUT Female Product supplied to Xxxxxxxx by Palomar under this ARTICLE III, such warranties as Xxxxxxxx may reasonably request to confirm that, during the Commercial Assessment Period, the CUT Female Products conform to the CUT Products Specifications and are in compliance with the applicable U.S. Regulatory Approval (which warranties shall not apply to any intellectual property rights).

• Table 5.4: Average weekly hours worked, by FMW category and sex At or below FMW Above FMW Total FemaleNotes: Mean usual weekly hours, weighted by cross-sectional weights.Source: HILDA Release 8.Population: All employed respondents reporting usual weekly hours.

More Definitions of U.S. Regulatory Approval

U.S. Regulatory Approval means final Regulatory Approval from the FDA and, if applicable, pricing and reimbursement approval in the US. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

U.S. Regulatory Approval means all approvals from the FDA necessary for the commercial manufacture, marketing and sale of a Product Candidate in the United States.

U.S. Regulatory Approval means with respect to the Licensed Product and a given Indication, Regulatory Approval by the FDA of the Licensed Product, and any required companion diagnostic, for that Indication; provided, that, if on the date of issuance of any such Regulatory Approval, a Governmental Authority having proper jurisdiction shall have issued an order, injunction or ruling (collectively, an “Order”) that restrains, enjoins or otherwise prohibits the sale of such Licensed Product in the U.S., U.S. Regulatory Approval shall be deemed to occur on the date on which such Order is withdrawn, removed or otherwise terminates.

U.S. Regulatory Approval means Regulatory Approval of the Product by the FDA with a regulatory label that allows the use of the Product for the primary treatment of invasive aspergillosis.

U.S. Regulatory Approval means Regulatory Approval from the FDA.

U.S. Regulatory Approval means the first achievement of Regulatory Approval of a BLA for

U.S. Regulatory Approval means the first date on which Lilly shall have received Regulatory Approval in the U.S.