PATENT-BASED EXCLUSIVITY PERIOD OR (B) REGULATORY-BASED
EXCLUSIVITY PERIOD, AND EXPIRING ON THE LATER OF THE EXPIRATION OF THE
(I) PATENT-BASED EXCLUSIVITY PERIOD OR (II) REGULATORY-BASED EXCLUSIVITY PERIOD.
SECTION 1.71
"LICENSED PRODUCT".
LICENSED PRODUCTS MEANS ANY RNAI PRODUCT
DIRECTED TO RSV.
SECTION 1.72
"MAJOR EU COUNTRY".
MAJOR EU COUNTRY MEANS ANY OF THE UNITED
KINGDOM, FRANCE, GERMANY, ITALY OR SPAIN.
SECTION 1.73
"MANUFACTURING" OR "MANUFACTURE".
MANUFACTURING OR MANUFACTURE
MEANS, AS APPLICABLE, ALL ACTIVITIES ASSOCIATED WITH THE PRODUCTION,
MANUFACTURE, SUPPLY, PROCESSING, FILLING, FINISHING, TESTING, PACKAGING,
LABELING, SHIPPING, AND STORAGE OF LICENSED PRODUCT OR PLACEBO (INCLUDING API
BULK DRUG SUBSTANCE AND FINISHED PRODUCT), INCLUDING PROCESS AND FORMULATION
DEVELOPMENT, PROCESS VALIDATION, STABILITY TESTING, MANUFACTURING SCALE-UP,
PRE-CLINICAL, CLINICAL AND COMMERCIAL MANUFACTURE AND ANALYTICAL DEVELOPMENT,
PRODUCT CHARACTERIZATION, QUALITY ASSURANCE AND QUALITY CONTROL DEVELOPMENT,
TESTING AND RELEASE.
SECTION 1.74
"N.A. PRE-TAX PROFIT OR LOSS".
N.A. PRE-TAX PROFIT OR LOSS MEANS
NET SALES OF LICENSED PRODUCT IN NORTH AMERICA BY CUBIST AND ITS AFFILIATES (BUT
NOT SUBLICENSEES) PLUS SUBLICENSE INCOME MINUS (A) COST OF GOODS SOLD,
(B) DISTRIBUTION COSTS AND (C)
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
12
COMMERCIALIZATION COSTS, IN EACH CASE DETERMINED FROM THE BOOKS AND RECORDS OF
THE APPLICABLE PARTY OR ITS RELATED PARTIES, MAINTAINED IN ACCORDANCE GAAP,
CONSISTENTLY APPLIED.
SECTION 1.75
"NECESSARY THIRD PARTY IP".
NECESSARY THIRD PARTY IP MEANS, ON A
COUNTRY-BY-COUNTRY BASIS, KNOW-HOW OR PATENT RIGHTS THAT ARE OWNED OR CONTROLLED
BY A THIRD PARTY AND COVER OR ARE OTHERWISE NECESSARY OR REASONABLY USEFUL FOR
THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF LICENSED PRODUCT IN THE
FIELD IN SUCH COUNTRY, AND ARE THE SUBJECT OF AN ALNYLAM IN-LICENSE OR A CUBIST
IN-LICENSE.
SECTION 1.76
"NET SALES".
NET SALES SHALL MEAN THE GROSS AMOUNT INVOICED BY
CUBIST, AND ITS AFFILIATES WITH RESPECT TO THE PROFIT-SHARE TERRITORY AND SHALL
MEAN THE GROSS AMOUNT INVOICED BY CUBIST AND ITS RELATED PARTIES WITH RESPECT TO
THE ROYALTY TERRITORY, IN EACH CASE ON SALES OR OTHER DISPOSITIONS (EXCLUDING
SALES OR DISPOSITIONS FOR USE IN CLINICAL TRIALS, OTHER SCIENTIFIC TESTING, OR
AS SAMPLES, OR AS PART OF COMPASSIONATE USE, PATIENT ASSISTANCE, NAMED PATIENT
OR TEST MARKETING PROGRAM OR ANY SIMILAR PROGRAM OR STUDY, OR OTHER SIMILAR
CASES, IN EACH CASE FOR WHICH CUBIST OR ITS RELATED PARTIES RECEIVE NO REVENUE)
OF LICENSED PRODUCT TO THIRD PARTIES, LESS THE FOLLOWING DEDUCTIONS:
(A)
TRADE, CASH AND QUANTITY DISCOUNTS AND ALLOWANCES ACTUALLY ALLOWED
AND TAKEN DIRECTLY WITH RESPECT TO SUCH SALES OR OTHER DISPOSITIONS;
(B)
TARIFFS, DUTIES, EXCISES, SALES TAXES, VALUE-ADDED OR OTHER TAXES
OR GOVERNMENTAL CHARGES IMPOSED UPON AND PAID DIRECTLY WITH RESPECT TO THE
DELIVERY, SALE OR USE OF LICENSED PRODUCT (EXCLUDING NATIONAL, STATE OR LOCAL
TAXES BASED ON INCOME);
(C)
AMOUNTS REPAID OR CREDITED BY REASON OF REJECTIONS, DEFECTS,
RECALLS OR RETURNS OR BECAUSE OF REASONABLE AND CUSTOMARY CHARGEBACKS, REFUNDS,
REBATES (INCLUDING REBATES TO MANAGED CARE ORGANIZATIONS, GROUP PURCHASING
ORGANIZATIONS, PHARMACY BENEFIT MANAGEMENT COMPANIES, HEALTH MAINTENANCE
ORGANIZATIONS, HEALTHCARE INSTITUTIONS, OTHER BUYING GROUPS OR PROVIDERS OF
HEALTHCARE OR SOCIAL AND WELFARE SYSTEMS, OR IN