THE FEDERAL MEDICARE AND
MEDICAID PROGRAMS (INCLUDING THE MEDICAID REBATE PROGRAM); FEDERAL LAWS
PERTAINING TO THE FEDERAL EMPLOYEES HEALTH BENEFIT PROGRAM, THE TRICARE PROGRAM
AND OTHER GOVERNMENT HEALTH CARE PROGRAMS; FEDERAL AND STATE LAWS APPLICABLE TO
HEALTH CARE FRAUD AND ABUSE, KICKBACKS, PHYSICIAN SELF-REFERRAL AND FALSE CLAIMS
(INCLUDING 42 U.S.C. § 1320A-7A, 42 U.S.C. § 1320A-7B, 42 U.S.C. § 1395NN AND
THE FEDERAL CIVIL FALSE CLAIMS ACT, 31 U.S.C. § 3729 ET SEQ.); THE HEALTH
INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996; AND 45 C.F.R. PART 46,
EACH AS IN EFFECT AND AS AMENDED FROM TIME TO TIME.
SECTION 1.61
"ICH".
ICH MEANS THE INTERNATIONAL CONFERENCE ON HARMONIZATION OF
TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE.
SECTION 1.62
"IND".
IND MEANS AN INVESTIGATIONAL NEW DRUG APPLICATION FILED
WITH FDA OR A SIMILAR APPLICATION FILED WITH AN APPLICABLE REGULATORY AUTHORITY
OUTSIDE OF THE UNITED STATES SUCH AS A CLINICAL TRIAL APPLICATION (CTA) OR A
CLINICAL TRIAL EXEMPTION (CTX).
SECTION 1.63
"INVESTIGATOR SPONSORED CLINICAL STUDY". INVESTIGATOR SPONSORED
CLINICAL STUDY MEANS A HUMAN CLINICAL STUDY OF LICENSED PRODUCT THAT IS
SPONSORED AND CONDUCTED BY A THIRD PARTY UNDER AN AGREEMENT WITH A PARTY
PURSUANT TO WHICH SUCH PARTY PROVIDES CLINICAL SUPPLIES OF LICENSED PRODUCT OR
FUNDING FOR SUCH CLINICAL STUDY.
SECTION 1.64
"JOINT COLLABORATION IP".
JOINT COLLABORATION IP MEANS,
COLLECTIVELY, (A) ANY IMPROVEMENT, DISCOVERY OR KNOW-HOW, PATENTABLE OR
OTHERWISE, FIRST IDENTIFIED, DISCOVERED OR DEVELOPED JOINTLY BY THE PARTIES OR
THEIR AFFILIATES OR OTHERS ACTING ON BEHALF OF CUBIST AND ALNYLAM OR THEIR
AFFILIATES IN THE CONDUCT OF THE COLLABORATION, AND (B) ANY PATENT RIGHTS WHICH
CLAIM OR COVER SUCH IMPROVEMENTS, DISCOVERIES OR KNOW-HOW DURING THE TERM.
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
11
SECTION 1.65
"KNOW-HOW".
KNOW-HOW MEANS ALL BIOLOGICAL MATERIALS AND OTHER
TANGIBLE MATERIALS, INVENTIONS, PRACTICES, METHODS, PROTOCOLS, FORMULAS,
KNOWLEDGE, KNOW-HOW, TRADE SECRETS, PROCESSES, PROCEDURES, ASSAYS, SKILLS,
EXPERIENCE, TECHNIQUES AND RESULTS OF EXPERIMENTATION AND TESTING, INCLUDING
PHARMACOLOGICAL, TOXICOLOGICAL AND PRE-CLINICAL AND CLINICAL TEST DATA AND
ANALYTICAL AND QUALITY CONTROL DATA, PATENTABLE OR OTHERWISE.
SECTION 1.66
"KNOWLEDGE OF ALNYLAM".
KNOWLEDGE OF ALNYLAM MEANS THE []*.
SECTION 1.67
"KYOWA AGREEMENT".
KYOWA AGREEMENT MEANS THE LICENSE AND
COLLABORATION AGREEMENT ENTERED INTO BY AND BETWEEN ALNYLAM AND KYOWA HAKKO AS
OF JUNE 19, 2008, WITH RESPECT TO THE DEVELOPMENT AND COMMERCIALIZATION OF
LICENSED PRODUCT IN ASIA.
SECTION 1.68
"KYOWA HAKKO".
KYOWA HAKKO MEANS KYOWA HAKKO KIRIN CO., LTD.
(FORMERLY KNOWN AS KYOWA HAKKO KOGYO CO., LTD.), A CORPORATION ORGANIZED AND
EXISTING UNDER THE LAWS OF JAPAN.
SECTION 1.69
"LAW".
LAW MEANS ANY UNITED STATES FEDERAL, STATE OR LOCAL OR
FOREIGN OR MULTINATIONAL LAW, STATUTE, STANDARD, ORDINANCE, CODE, RULE,
REGULATION, RESOLUTION OR PROMULGATION, OR ANY GOVERNMENT ORDER, OR ANY LICENSE,
FRANCHISE, PERMIT OR SIMILAR RIGHT GRANTED UNDER ANY OF THE FOREGOING, OR ANY
SIMILAR PROVISION HAVING THE FORCE OR EFFECT OF LAW.
SECTION 1.70
"LEGAL EXCLUSIVITY PERIOD".
LEGAL EXCLUSIVITY PERIOD MEANS, WITH
RESPECT TO A LICENSED PRODUCT, THE PERIOD BEGINNING ON THE EARLIER OF THE
COMMENCEMENT OF THE (A)