"REGULATORY AUTHORITY".
REGULATORY AUTHORITY MEANS ANY FEDERAL,
NATIONAL, MULTINATIONAL, STATE, PROVINCIAL OR LOCAL REGULATORY AGENCY,
DEPARTMENT, BUREAU OR OTHER GOVERNMENTAL ENTITY WITH AUTHORITY OVER THE
MANUFACTURING, MARKETING, SALE OR USE OF A PHARMACEUTICAL PRODUCT IN A COUNTRY,
INCLUDING THE FDA IN THE UNITED STATES AND THE EMEA IN THE EU.
SECTION 1.96
"REGULATORY-BASED EXCLUSIVITY PERIOD".
REGULATORY-BASED
EXCLUSIVITY PERIOD MEANS, WITH RESPECT TO A LICENSED PRODUCT IN A COUNTRY IN THE
ROYALTY TERRITORY, THAT PERIOD OF TIME DURING WHICH CUBIST OR ANY OF ITS RELATED
PARTIES HAS BEEN GRANTED THE EXCLUSIVE LEGAL RIGHT BY A REGULATORY AUTHORITY (OR
IS OTHERWISE ENTITLED TO THE EXCLUSIVE LEGAL RIGHT BY OPERATION OF APPLICABLE
LAW) IN SUCH COUNTRY TO MARKET AND SELL THE ACTIVE INGREDIENT CONTAINED IN SUCH
LICENSED PRODUCT IN SUCH COUNTRY.
SECTION 1.97
"RELATED PARTY".
RELATED PARTY MEANS (A) WITH RESPECT TO CUBIST,
ANY OF CUBIST'S AFFILIATES OR SUBLICENSEES, AND, (B) WITH RESPECT TO ALNYLAM,
ANY OF ALNYLAM'S AFFILIATES OR SUBLICENSEES AND ALNYLAM'S ASIAN PARTNER.
SECTION 1.98
"RNAI PRODUCT".
RNAI PRODUCT MEANS A DOUBLE-STRANDED
OLIGONUCLEOTIDE MOLECULE DESIGNED TO ACT PRIMARILY THROUGH AN RNA INTERFERENCE
MECHANISM THAT IS NOT A MICRORNA, MICRORNA ANTAGONIST OR MICRORNA MIMIC AND
WHICH CONSISTS OF EITHER (A) TWO SEPARATE OLIGOMERS OF NATIVE OR CHEMICALLY
MODIFIED RNA THAT ARE HYBRIDIZABLE TO ONE ANOTHER ALONG A SUBSTANTIAL PORTION OF
THEIR LENGTHS, OR (B) A SINGLE OLIGOMER OF NATIVE OR CHEMICALLY MODIFIED RNA
THAT IS HYBRIDIZABLE TO ITSELF BY SELF-COMPLEMENTARY BASE-PAIRING ALONG A
SUBSTANTIAL PORTION OF ITS LENGTH TO FORM A HAIRPIN, IN EITHER CASE THAT
INACTIVATES, INCLUDING INACTIVATION RESULTING FROM CLEAVAGE, A TARGET MRNA,
WHICH ENCODES A PROTEIN PRODUCT, VIA A DOUBLE-STRANDED RNASE, SUCH AS THOSE
INVOLVED IN THE RNA INTERFERENCE MECHANISM.
SECTION 1.99
"ROYALTY TERRITORY".
ROYALTY TERRITORY MEANS, SUBJECT TO
SECTION 4.7, THE ENTIRE TERRITORY OTHER THAN NORTH AMERICA.
SECTION 1.100
"RSV". RSV MEANS ALL STRAINS OF THE RESPIRATORY SYNCYTIAL VIRUS.
SECTION 1.101
"RSV01 PRODUCT".
RSV01 PRODUCT MEANS ANY PRODUCT CONTAINING
ALNYLAM'S PROPRIETARY COMPOSITION KNOWN AS ALN-RSV01.
ALN-RSV01 IS DESCRIBED ON
EXHIBIT B.
SECTION 1.102
"RSV02 PRODUCT".
RSV02 PRODUCT MEANS ANY PRODUCT CONTAINING
ALNYLAM'S PROPRIETARY COMPOSITION DESIGNATED BY THE JSC AS ALN-RSV02.
SECTION 1.103
"SAFETY DATA".
SAFETY DATA MEANS ADVERSE EVENT INFORMATION AND
OTHER INFORMATION (IF ANY) REQUIRED BY ONE (1) OR MORE REGULATORY AUTHORITIES TO
BE COLLECTED OR TO BE REPORTED TO SUCH REGULATORY AUTHORITIES UNDER APPLICABLE
LAWS.
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
17
SECTION 1.104
"SALES REPRESENTATIVE".
SALES REPRESENTATIVE MEANS AN
INDIVIDUAL, WHO ENGAGES IN OR MANAGES SALES CALLS AND OTHER PROMOTIONAL EFFORTS
WITH RESPECT TO LICENSED PRODUCT AND WHO IS EMPLOYED BY A PARTY OR AN AFFILIATE
OF A PARTY.
SECTION 1.105
"SECOND OPT-OUT MILESTONE".
SECOND OPT-OUT MILESTONE MEANS THE
EARLIER TO OCCUR OF: (A) []*.
FOR THE AVOIDANCE OF DOUBT, IF THERE IS A
DEADLOCK AT THE JSC WITH RESPECT TO THE DETERMINATION IN CLAUSE (B), THEN []*.
SECTION 1.106
"SUBLICENSEE".
SUBLICENSEE, AS TO A LICENSED PRODUCT, MEANS ANY
THIRD PARTY TO WHOM A PARTY OR ANY OF ITS