DATE HEREWITH.
1.24
"LEAD COMPOUND" SHALL MEAN ANY HIT OR SCHERING
COMPOUND WITH RESPECT TO WHICH THE PARTIES AGREE TO INITIATE A PROGRAM OF
MEDICINAL CHEMISTRY TO IDENTIFY A DEVELOPMENT CANDIDATE BASED UPON THE STRUCTURE
OF SUCH HIT OR SCHERING COMPOUND.
1.23
"MAJOR MARKET" SHALL MEAN JAPAN OR ANY THREE (3)
OF THE FOLLOWING COUNTRIES; FRANCE, GERMANY, ITALY, SPAIN OR THE UNITED KINGDOM.
1.26
"NDA" SHALL MEAN A NEW DRUG APPLICATION, PRODUCT
LICENSE APPLICATION, OR BIOLOGIC LICENSE APPLICATION, AS DEFINED IN THE U.S.
FOOD, DRUG AND COSMETICS ACT AND REGULATIONS PROMULGATED THEREUNDER, OR THE
EQUIVALENT FILED WITH THE FDA SEEKING APPROVAL TO MARKET AND SELL AN AGREEMENT
PRODUCT IN THE UNITED STATES.
1.27
"NET SALES" SHALL MEAN, WITH RESPECT TO EACH
COUNTRY IN THE TERRITORY, THE INVOICE PRICE BILLED BY SCHERING OR ITS
AFFILIATES, OR THEIR RESPECTIVE SUBLICENSEES, TO THIRD PARTIES (WHETHER AN
END-USER, A DISTRIBUTOR OR OTHERWISE) FOR THE SALE OF AGREEMENT PRODUCTS, AND
EXCLUSIVE OF INTERCOMPANY TRANSFERS OR SALES AMONG SCHERING, ITS AFFILIATES
AND/OR SUBLICENSEES IN THE TERRITORY, LESS THE REASONABLE AND CUSTOMARY
DEDUCTIONS FROM SUCH GROSS AMOUNTS INCLUDING:
(I) NORMAL AND CUSTOMARY TRADE,
CASH AND QUANTITY DISCOUNTS, ALLOWANCES AND CREDITS;
(II) CREDITS OR ALLOWANCES
ACTUALLY GRANTED FOR DAMAGED GOODS, RETURNS OR REJECTIONS OF AGREEMENT PRODUCT
AND RETROACTIVE PRICE REDUCTIONS;
(III) SALES OR SIMILAR TAXES (INCLUDING
DUTIES OR OTHER GOVERNMENTAL CHARGES LEVIED ON, ABSORBED OR OTHERWISE IMPOSED ON
THE SALE OF AGREEMENT PRODUCT INCLUDING, WITHOUT LIMITATION, VALUE ADDED TAXES
OR OTHER GOVERNMENTAL CHARGES OTHERWISE MEASURED BY THE BILLING AMOUNT, WHEN
INCLUDED IN BILLING);
(IV) FREIGHT, POSTAGE, SHIPPING, CUSTOMS DUTIES AND
INSURANCE CHARGES, WHEN INCLUDED IN BILLING; (V) CHARGE BACK PAYMENTS AND
REBATES GRANTED TO MANAGED HEALTH
3
CARE ORGANIZATIONS OR THEIR AGENCIES, AND PURCHASERS AND REIMBURSERS OR TO TRADE
CUSTOMERS, INCLUDING BUT NOT LIMITED TO, WHOLESALERS AND CHAIN AND PHARMACY
BUYING GROUPS;
(VI) COMMISSIONS PAID TO THIRD PARTIES OTHER THAN SALES
PERSONNEL AND SALE REPRESENTATIVES OR SALES AGENTS; AND
(VII) REBATES (OR
EQUIVALENTS THEREOF) GRANTED TO OR CHARGED BY NATIONAL, STATE OR LOCAL
GOVERNMENTAL AUTHORITIES IN A COUNTRY IN THE TERRITORY.
IN DETERMINING NET
SALES OF AN AGREEMENT PRODUCT ANY OF THE ABOVE DISCOUNTS SHALL BE ACCOUNTED FOR
AND APPORTIONED BASED ON THE LIST PRICE OF EACH SUCH AGREEMENT PRODUCT.
In the event that an Agreement Product is sold in the form of a Combination
Product, Net Sales for such Combination Product will be calculated by
multiplying actual Net Sales of such Combination Product by the fraction A/(A+B)
where: A is the invoice price of the Agreement Product contained in the
Combination Product if sold separately by Schering, an Affiliate or Sublicensee;
and B is the invoice price of any other active therapeutic ingredients in the
Combination Product if sold separately by Schering, an Affiliate or
Sublicensee.
In the event that the Agreement Product is sold in the form of a
Combination Product containing one or more active therapeutic ingredients other
than an Agreement Product and one or more such active therapeutic ingredients of
the Combination Product