DESI Product definition
Examples of DESI Product in a sentence
To the extent that the United States Food and Drug Administration ("FDA") has a required protocol for the studies designed to demonstrate the bioequivalency of a Product, other than a DESI Product (an "FDA Protocol"), then within sixty days of the delivery of such Product pursuant to Section 1 hereof, Caraco shall deliver, in writing, to Sun, a proposed protocol, which is believed in good faith by Caraco to be acceptable to the FDA (or, if applicable, a waiver of evidence of in vivo bioavailability).
The consideration for each Product (other than a DESI Product) delivered shall be 544,000 (as such number may be adjusted from time to time pursuant to Section 5 hereof) shares of common stock, no par value, of Caraco ("Common Shares").
For the purposes of this Agreement "DESI Product" shall mean Drug Efficiency Study Implementation Products, which can be marketed based on past marketing of an identical product that is not the subject of an approved drug application and thus does not require an ANDA (as defined below) to be marketed in compliance with the Federal Food, Drug and Cosmetics Act, as amended, and the regulations thereunder.
The consideration for each DESI Product delivered shall be 181,333 (as such number may be adjusted from time to time pursuant to Section 5 hereof) Common Shares.
To the extent that no FDA Protocol exists with respect to a Product (other than a DESI Product) delivered pursuant to Section 1 hereof, Caraco will, in consultation with the FDA and Sun, develop such a protocol within 150 days of delivery of such Product by Sun; and will promptly deliver such protocol to Sun after it has been developed.