NECESSARY OR USEFUL FOR MANUFACTURING THE COMBINATION PRODUCT
FROM BULK ACTIVE PHARMACEUTICAL INGREDIENTS, ANY IMPROVEMENTS THERETO OR ANY
INTERMEDIATE OF THE FOREGOING.
1.148
"MARKET" OR "MARKETING" SHALL MEAN ALL PROGRAMS AND
ACTIVITIES RELATING TO THE PROMOTION AND SALE AND OTHER COMMERCIALIZATION OF THE
COMBINATION PRODUCT IN THE TERRITORY, INCLUDING, WITHOUT LIMITATION, DETAILING
AND ADVERTISING, AS WELL AS SELLING, CONTRACTING FOR SALE OF, AND DISTRIBUTING
THE COMBINATION PRODUCT.
1.149
"MATERIAL DEFAULT" SHALL HAVE THE MEANING SET FORTH IN
SECTION 14.4(A).
1.150
"MEMBER PARTIES" SHALL MEAN, COLLECTIVELY, GILEAD AND
BMS.
1.151
"MEMBERS" SHALL MEAN, COLLECTIVELY, GILEAD SUB AND BMS
SUB.
1.152
"MEMBER VOTE" SHALL HAVE THE MEANING SET FORTH IN
SECTION 2.6(F).
1.153
"[*]" SHALL HAVE THE MEANING SET FORTH IN
SECTION 5.1(F).
1.154
"[*]" SHALL HAVE THE MEANING SET FORTH IN
SECTION 5.1(F).
1.155
"MTTA" SHALL HAVE THE MEANING SET FORTH IN
SECTION 15.14.
1.156
"NDA" SHALL MEAN A NEW DRUG APPLICATION TO BE FILED
WITH THE FDA IN ACCORDANCE WITH APPLICABLE LAW FOR THE PURPOSE OF OBTAINING
MARKETING APPROVAL FOR A PHARMACEUTICAL PRODUCT IN THE UNITED STATES.
1.157
"[*]" SHALL HAVE THE MEANING SET FORTH IN ANNEX Q.
1.158
"NET SALES" SHALL MEAN, WITH RESPECT TO A PRODUCT FOR
ANY PERIOD, THE GROSS AMOUNT INVOICED FOR COMMERCIAL SALES OF THAT PRODUCT IN
SUCH PERIOD BY OR ON BEHALF OF THE SELLING PARTY TO THIRD PARTIES (PROVIDED THAT
AMOUNTS INVOICED FOR PRODUCT SOLD OR PROVIDED FOR USE IN THE DEVELOPING WORLD,
IF ANY, SHALL NOT BE INCLUDED), LESS DEDUCTIONS FOR:
(A) NORMAL AND CUSTOMARY
QUANTITY AND/OR CASH DISCOUNTS AND SALES RETURNS AND ALLOWANCES, INCLUDING,
WITHOUT LIMITATION, THOSE GRANTED ON ACCOUNT OF PRICE ADJUSTMENTS, BILLING
ERRORS, REJECTED GOODS, DAMAGED GOODS, RETURNS, REBATES, ADMINISTRATIVE OR OTHER
FEES OR REIMBURSEMENTS OR SIMILAR PAYMENTS TO WHOLESALERS OR OTHER DISTRIBUTORS
(INCLUDING WITHOUT LIMITATION PURSUANT TO INVENTORY MANAGEMENT AGREEMENTS),
BUYING GROUPS, AIDS DRUG ASSISTANCE PROGRAMS, PHARMACY BENEFIT MANAGEMENT
15
ORGANIZATIONS, HEALTH CARE INSURANCE CARRIERS OR OTHER INSTITUTIONS, ALLOWANCES,
REBATES, FEES PAID TO DISTRIBUTORS AND CHARGEBACKS ACTUALLY ALLOWED OR GIVEN;
(B) FREIGHT, POSTAGE, SHIPPING AND INSURANCE EXPENSES (IF SEPARATELY IDENTIFIED
IN SUCH INVOICE); (C) CUSTOMS OR EXCISE DUTIES OR OTHER DUTIES RELATED TO THE
SALES MAKING UP THE GROSS INVOICE AMOUNT (IF SEPARATELY IDENTIFIED IN SUCH
INVOICE); (D) ANY REBATES OR SIMILAR PAYMENTS ACCRUED WITH RESPECT TO SALES PAID
FOR BY ANY GOVERNMENTAL OR REGULATORY AUTHORITY SUCH AS, BY WAY OF ILLUSTRATION
AND NOT IN LIMITATION OF THE FOREGOING IN THIS CLAUSE (D), UNITED STATES FEDERAL
OR STATE MEDICAID, MEDICARE OR SIMILAR STATE PROGRAM OR ANY GOVERNMENT IMPOSED
RETROACTIVE PRICE REDUCTION; AND (E) SALES AND OTHER TAXES AND DUTIES DIRECTLY
RELATED TO THE SALE, TO THE EXTENT THAT SUCH ITEMS ARE INCLUDED IN THE GROSS
INVOICE PRICE (BUT NOT INCLUDING TAXES ASSESSED AGAINST THE INCOME DERIVED FROM
SUCH SALE).
ANY OF THE DEDUCTIONS LISTED ABOVE THAT INVOLVES A PAYMENT BY SUCH
PARTY SHALL NOT BE TAKEN AS A DEDUCTION PRIOR TO THE DATE ACCRUED IN ACCORDANCE
WITH GAAP AS CONSISTENTLY APPLIED IN SUCH PARTY'S AUDITED FINANCIAL STATEMENTS.