WOULD TYPICALLY DEVOTE TO A PRODUCT OF SIMILAR MARKET POTENTIAL,
PROFIT POTENTIAL, SIMILAR STAGE IN DEVELOPMENT OR COMMERCIALIZATION, OR
STRATEGIC VALUE RESULTING FROM ITS OWN RESEARCH EFFORTS, BASED ON CONDITIONS
THEN PREVAILING, AND TAKING INTO ACCOUNT OTHER RELEVANT FACTORS, INCLUDING
TECHNICAL, MEDICAL, CLINICAL EFFICACY, SAFETY, MANUFACTURING, AND DELIVERY
CONSIDERATIONS, PRODUCT LABELING OR ANTICIPATED LABELING, THE PATENT AND OTHER
PROPRIETARY POSITION OF THE PRODUCT, THE REGULATORY ENVIRONMENT AND COMPETITIVE
MARKET CONDITIONS.
DILIGENT EFFORTS WITH RESPECT TO ALNYLAM'S OBLIGATIONS, AS
SPECIFIED IN SECTIONS 3.3, 4.3(B), 5.9, 6.1(B) AND 9.6
RELATED TO THE ACTIONS
OF ITS RELATED PARTIES OR THE ACTIONS OF ANY OTHER THIRD PARTY WITH WHOM ALNYLAM
HAS ENTERED INTO AN AGREEMENT RELATED TO LICENSED PRODUCT SHALL MEAN THAT (A) TO
THE EXTENT SUCH OBLIGATION IS NOT CURRENTLY INCLUDED IN ITS AGREEMENT WITH SUCH
RELATED PARTY OR OTHER THIRD PARTY, ALNYLAM SHALL []*, (B) IN ENTERING INTO ANY
NEW AGREEMENT WITH A RELATED PARTY OR SUCH OTHER THIRD PARTY, ALNYLAM SHALL []*,
AND (C) IN EACH CASE, ALNYLAM SHALL TAKE REASONABLE ACTION TO ENFORCE SUCH
OBLIGATIONS.
SECTION 1.37
"DIRECTLY COMPETITIVE PRODUCT".
DIRECTLY COMPETITIVE PRODUCT
MEANS ANY THERAPEUTIC OR PROPHYLACTIC PRODUCT THAT SPECIFICALLY TARGETS RSV.
FOR AVOIDANCE OF DOUBT, DIRECTLY COMPETITIVE PRODUCT AS TO A PARTY SHALL NOT
INCLUDE A PRODUCT WITH []*.
SECTION 1.38
"DISTRIBUTION COSTS".
DISTRIBUTION COSTS MEANS THE COSTS,
EXCLUDING []*, INCURRED BY A PARTY OR ANY OF ITS RELATED PARTIES OR FOR ITS
ACCOUNT, SPECIFICALLY IDENTIFIABLE TO THE DISTRIBUTION OF A LICENSED PRODUCT TO
A THIRD PARTY IN THE FIELD INTENDED FOR COMMERCIAL SALE IN THE PROFIT-SHARE
TERRITORY, INCLUDING (A) HANDLING, TRANSPORTATION, CUSTOMS CLEARANCE,
CONTAINERS, FREIGHT, DUTIES AND INSURANCE (INCLUDING SHIPMENTS FROM THIRD PARTY
LOGISTICS SERVICE PROVIDERS TO WHOLESALERS, AND EXCLUDING SUCH COSTS, IF ANY,
TREATED AS A DEDUCTION IN THE DEFINITION OF NET SALES), (B) CUSTOMER SERVICES
INCLUDING ORDER ENTRY, BILLING AND ADJUSTMENTS, INQUIRY AND CREDIT AND
COLLECTION, AND (C) DIRECT COST OF FACILITIES UTILIZED FOR THE STORAGE AND
DISTRIBUTION OF LICENSED PRODUCT, DETERMINED FROM THE BOOKS AND RECORDS OF THE
APPLICABLE PARTY AND ITS AFFILIATES MAINTAINED IN ACCORDANCE WITH GAAP,
CONSISTENTLY APPLIED.
SECTION 1.39
"DMF".
DMF MEANS A DRUG MASTER FILE FILED WITH THE FDA, OR AN
EQUIVALENT FILING WITH ANY OTHER REGULATORY AUTHORITY.
SECTION 1.40
"DRUG REGULATION LAWS".
DRUG REGULATION LAWS MEANS LAWS
REGULATING DRUGS AND PHARMACEUTICAL PRODUCTS, INCLUDING THE UNITED STATES
FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. § 301 ET SEQ., THE PRESCRIPTION
DRUG MARKETING ACT OF 1987, THE FEDERAL CONTROLLED SUBSTANCES ACT, 21 U.S.C. §
801 ET SEQ., AND POLICIES ISSUED BY THE FDA, AND SIMILAR
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
8
LAWS OF THE EMEA OR OTHER COUNTRIES OR JURISDICTIONS IN THE TERRITORY, EACH AS
IN EFFECT AND AS AMENDED FROM TIME TO TIME.
SECTION 1.41
"EMEA".
EMEA MEANS THE EUROPEAN MEDICINES AGENCY OR ANY SUCCESSOR
AGENCY THERETO.
SECTION 1.42
"EUROPEAN UNION" OR "EU".
EUROPEAN UNION OR EU MEANS THE
COUNTRIES OF THE EUROPEAN UNION, AS IT IS CONSTITUTED AS OF THE EFFECTIVE