THE JAPANESE MINISTRY OF HEALTH, LABOR AND WELFARE, OR
A SUCCESSOR AGENCY THERETO.
1.54
"NDA" MEANS (A) (I) A NEW DRUG APPLICATION SUBMITTED TO THE FDA, OR
ANY SUCCESSOR APPLICATION OR PROCEDURE, AS MORE FULLY DEFINED IN 21 C.F.R. §
314.50 ET. SEQ.; OR (II) ANY NON-UNITED STATES COUNTERPART OF SUCH A NEW DRUG
APPLICATION; AND (B) ALL SUPPLEMENTS AND AMENDMENTS, INCLUDING SUPPLEMENTAL NEW
DRUG APPLICATIONS (AND ANY NON-UNITED STATES COUNTERPARTS) THAT MAY BE FILED
WITH RESPECT TO THE FOREGOING.
1.55
"NET SALES" MEANS, WITH RESPECT TO ANY LICENSED PRODUCT, THE GROSS
AMOUNT INVOICED BY LILLY OR ITS AFFILIATES, OR SUBLICENSEES ON SALES OR OTHER
DISPOSITIONS OF LICENSED PRODUCT TO THIRD PARTIES, OR OTHERWISE DIRECTLY OR
INDIRECTLY PAID TO OR EARNED BY LILLY OR ITS AFFILIATES OR SUBLICENSEES WITH
RESPECT TO THE SALE OF LICENSED PRODUCT, LESS THE FOLLOWING:
(A)
TRADE, CASH AND/OR QUANTITY DISCOUNTS NOT ALREADY REFLECTED IN THE
AMOUNT INVOICED, TO THE EXTENT RELATED TO THE GROSS AMOUNT INVOICED;
7
(B)
ALLOWANCES AND ADJUSTMENTS CREDITED OR PAYABLE, INCLUDING CREDIT
FOR SPOILED, DAMAGED, OUTDATED, RECALLED AND RETURNED LICENSED PRODUCT, TO THE
EXTENT RELATED TO THE GROSS AMOUNT INVOICED AND SUBSTANTIATED BY REASONABLE
DOCUMENTATION;
(C)
FREIGHT, INSURANCE AND OTHER TRANSPORTATION CHARGES INCURRED IN
SHIPPING A PRODUCT TO THIRD PARTIES, TO THE EXTENT IDENTIFIED AS SUCH IN THE
INVOICE TO THE THIRD PARTY, TO THE EXTENT INCLUDED IN THE GROSS AMOUNT INVOICED;
(D)
AMOUNTS REPAID OR CREDITED BY REASON OF REJECTIONS, DEFECTS,
RECALLS OR RETURNS OR BECAUSE OF CHARGEBACKS, REFUNDS, REBATES (INCLUDING
WHOLESALER INVENTORY MANAGEMENT FEES, RETROACTIVE PRICE REDUCTIONS, COMMISSIONS,
DISCOUNTS OR BILLING ERRORS, AND ANY OTHER ALLOWANCES WHICH EFFECTIVELY REDUCE
THE NET SELLING PRICE);
(E)
ALL TARIFFS, DUTIES, EXCISES, SALES TAXES, OR OTHER TAXES
(INCLUDING VAT) AND CUSTOM DUTIES IMPOSED ON LICENSED PRODUCTS, IN EACH CASE TO
THE EXTENT INVOICED TO CUSTOMERS OR OTHERWISE INCLUDED WITHIN GROSS AMOUNTS
INVOICED;
(F)
ALLOWANCE FOR DISTRIBUTION EXPENSES; AND
(G)
OTHER SIMILAR AND CUSTOMARY DEDUCTIONS WHICH ARE IN ACCORDANCE
WITH US GAAP.
NET SALES WILL NOT INCLUDE SALES BETWEEN OR AMONG LILLY AND ITS AFFILIATES
AND/OR SUBLICENSEES; PROVIDED, HOWEVER, THAT ANY RESALE TO THIRD PARTIES SHALL
BE INCLUDED IN NET SALES.
NET SALES SHALL BE CALCULATED IN ACCORDANCE WITH LILLY'S STANDARD INTERNAL
POLICIES AND PROCEDURES, WHICH MUST BE IN ACCORDANCE WITH ACCOUNTING STANDARDS.
IN THE CASE OF ANY SALE OR OTHER DISPOSAL FOR VALUE, SUCH AS BARTER OR
COUNTER-TRADE, OF LICENSED PRODUCT, OR PART THEREOF, OTHER THAN IN AN ARM'S
LENGTH TRANSACTION EXCLUSIVELY FOR CASH, NET SALES SHALL BE CALCULATED AS ABOVE
ON THE VALUE OF THE NON-CASH CONSIDERATION RECEIVED OR THE FAIR MARKET PRICE (IF
HIGHER) OF THE LICENSED PRODUCT IN THE COUNTRY OF SALE OR DISPOSAL, AS
DETERMINED IN ACCORDANCE WITH ACCOUNTING STANDARDS. DONATED PRODUCT WILL BE
EXCLUDED FROM NET SALES.
IN THE EVENT THE LICENSED PRODUCT IS SOLD IN A FINISHED DOSAGE FORM CONTAINING
THE LICENSED PRODUCT IN COMBINATION WITH ONE OR MORE OTHER ACTIVE INGREDIENTS (A
"COMBINATION PRODUCT"), THE NET SALES OF THE LICENSED PRODUCT, FOR THE PURPOSES
OF