APPLICATION REQUESTING
REGULATORY APPROVAL FOR THE MARKETING AND/OR COMMERCIALIZATION OF A LICENSED
PRODUCT FOR A PARTICULAR INDICATION IN A JURISDICTION, INCLUDING WITHOUT
LIMITATION AN NDA FILED WITH THE FDA AND SIMILAR AND EQUIVALENT FILINGS WITH
REGULATORY AUTHORITIES IN JURISDICTIONS OTHER THAN THE UNITED STATES. IT IS
UNDERSTOOD THAT MAA DOES NOT INCLUDE APPLICATIONS FOR PRICING OR REIMBURSEMENT
APPROVAL.
1.31
"MARKETING AUTHORIZATION" SHALL MEAN, WITH
RESPECT TO A PARTICULAR JURISDICTION IN THE TERRITORY, ANY AUTHORIZATION WHICH
IS LEGALLY REQUIRED UNDER APPLICABLE LAWS, REGULATIONS, ADMINISTRATIVE
DECISIONS, OR OTHERWISE TO PUT A PHARMACEUTICAL PRODUCT ON THE MARKET OR FOR
COMMERCIAL SALE IN THE JURISDICTION FOR USE IN TREATMENT OF ANY INDICATION. IT
IS UNDERSTOOD THAT, AS USED HEREIN, MARKETING AUTHORIZATION DOES NOT INCLUDE
PRICING OR REIMBURSEMENT APPROVAL.
1.32
"MAJOR COUNTRY" SHALL MEAN THE UNITED STATES,
JAPAN, FRANCE, GERMANY, ITALY, SPAIN, AND THE UNITED KINGDOM.
1.33
"MANUFACTURE" SHALL MEAN MANUFACTURING AND
RELATED ACTIVITIES INCLUDING FILLING, PROCESSING, TESTING, ENGINEERING,
DESIGNING, REDESIGNING, FINISHING, PACKAGING, LABELING, STORING, WAREHOUSING,
QUALITY CONTROL, QUALITY ASSURANCE, RELEASING, DISPOSING, HANDLING, SHIPPING,
AND ALL OTHER ACTIVITIES UNDERTAKEN OR REQUIRED TO BE UNDERTAKEN IN ORDER TO
MANUFACTURE, SUPPLY AND DISTRIBUTE LICENSED PRODUCT.
1.34
"NDA" SHALL MEAN A NEW DRUG APPLICATION AND
AMENDMENTS AND SUPPLEMENTS THERETO FILED WITH THE FDA.
6
1.35
"NET SALES" SHALL MEAN THE GROSS AMOUNT INVOICED
ON THE LAST SALE OF THE LICENSED PRODUCT BY MGI, LICENSEES, AND THEIR
AFFILIATES, LESS REASONABLE AND CUSTOMARY DEDUCTIONS FOR (A) CREDITS FOR
RETURNS, INCLUDING WITHDRAWALS AND RECALLS; (B) SALES REBATES AND CHARGEBACKS;
(C) SALES, VALUE-ADDED AND OTHER TAXES (BUT IN THE CASE OF VALUE ADDED TAXES
ONLY TO THE EXTENT SUCH TAXES ARE NOT REIMBURSABLE OR REFUNDABLE); AND (D)
CUSTOMS DUTIES ON SALES MADE BY SUCH SELLER TO THE CUSTOMER; BUT IN THE CASE OF
(A) AND (B) ONLY TO THE EXTENT ACCRUED UNDER ACCOUNTING PRINCIPLES GENERALLY
ACCEPTED IN THE U.S. (AND REFLECTED IN PUBLIC REGULATORY FILINGS) AS BEING
DEDUCTIONS THAT HAVE ACTUALLY BEEN GIVEN TO AND TAKEN BY THE CUSTOMER AND IN THE
CASE OF (C) AND (D) ONLY TO THE EXTENT SEPARATELY ITEMIZED IN THE INVOICE TO AND
PAID BY THE CUSTOMER. IF A LICENSED PRODUCT IS SOLD FOR CONSIDERATION OTHER THAN
SOLELY CASH, THE FAIR MARKET VALUE OF SUCH OTHER CONSIDERATION SHALL BE INCLUDED
IN THE CALCULATION OF NET SALES. FOR PURPOSES OF CALCULATING NET SALES,
TRANSFERS OF A LICENSED PRODUCT TO AN AFFILIATE OR LICENSEE FOR END USE BY SUCH
AFFILIATE OR LICENSEE IN A COUNTRY SHALL BE TREATED AS A SALE AT THE GREATER OF
THE ACTUAL NET SALES AND THE AVERAGE NET SALES PRICE FOR FULLY ARMS-LENGTH SALES
OF SUCH LICENSED PRODUCT IN SUCH COUNTRY DURING THE APPLICABLE CALENDAR QUARTER.
HOWEVER, THE PARTIES AGREE THAT WITH RESPECT TO THE U.S., WHOLESALERS AND
DISTRIBUTORS ACTING IN THE ORDINARY COURSE OF THEIR BUSINESS AS THEY NORMALLY
OPERATE WITH RESPECT TO THE PHARMACEUTICAL INDUSTRY ARE NOT LICENSEES, BUT SUCH
EXCLUSION SHALL APPLY ONLY FOR PURPOSES OF THIS DEFINITION OF NET SALES AND
SECTION 3.3 HEREOF.
1.36
"ORPHAN PRODUCT DESIGNATIONS" SHALL