FDA Product definition
Examples of FDA Product in a sentence
On or before the fifth Business Day following (i) any FDA Payment Trigger Date and (ii) July 1, 2019, Parent will deliver to the Rights Agent a notice (the “FDA Approval Payment Notice”) indicating whether FDA Product Approval was achieved, and if achieved, whether FDA Preferred Product Label Approval was achieved.
Accentia will seek approval of the FDA and other Regulatory Authorities for an encochleated form of FDA Product using the cochleate technology licensed by Accentia under the BDSI License Agreement.
Purchaser acknowledges that the FDA Product and Establishment fees are due on or before October 1st 2012 for the fiscal year beginning on October 1st 2012 and lasting through September 30, 2013.
Set forth on Schedule 5.12 is a report of the Seller's aggregate gross revenue, deductions, net sales, cost of goods sold (including FDA Product Fees for 2010 and 2011), gross profit, FDA Product Fees (reported separately for 2009 only), coupon reimbursement and all other direct and indirect operating costs in respect of the Product for (i) the twelve (12) month periods ended December 31, 2009 and December 31, 2010, and (ii) the two (2) month period ended February 28, 2011.
If FDA Product Approval is obtained, and the parties do not enter into a Distribution Agreement within six (6) months of the date of the FDA Product Approval, HEB shall pay to Olsten an amount up to but not to exceed, in the aggregate, the sum of $500,000.00 for all documented costs and expenses incurred by Olsten in connection with the pharma-economic EPI-Q Study and dedicated personnel (including salary and benefits) referred to in Section 2.17 below.
On September 30, 2015, Purchaser shall pay to Seller Two Hundred Twenty-Six Thousand Five Hundred Twenty-Three Dollars ($226,523) representing one-third (1/3) of the sum of the FDA Product Fee and the FDA Establishment Fee for the period of October 1, 2014 to September 30, 2015.
In addition, if the Product receives FDA approval, then HEB agrees that the fee schedule shall be in effect for Patients enrolled in the AMP-S 11 Protocol at the time of FDA Product Approval and Olsten shall be entitled to purchase the Product for said Patients at the prices set forth therein.
Such Reports shall be in sufficient detail for MAYO to determine whether ACCENTIA is using best efforts to pursue the Regulatory Approvals and to protect the rights to Marketing Exclusivity, and to determine whether ACCENTIA is using its best efforts for Commercialization of an FDA Product.
EXHIBIT-A Data Specification Sheet for Oxyview(R) --------------------------------------- OxyView(TM): Registered Trademark Serial No. 78-886168 FDA Registration No. 3005686889 FDA Owner/Operator No. ▇▇▇▇▇▇▇ FDA Product Code: BYM FDA Listing No. E376132 FDA/Department of Health Services License No. 47146 Patent(s): United States, Japan, European Communities, and People's Republic of China Description: OxyView(TM) relates to flow meters which provide a visual signal for gas flow through a conduit.
ACCENTIA shall provide MAYO or its designee, on or before May 1 and November 1 of each year, with all raw data and research on any FDA Product, which research could reasonably be used to support any filing with a Regulatory Authority with respect to an FDA Product.