commencing good faith negotiations, the
issue shall be referred to dispute resolution in accordance with Article XII.
Notwithstanding the foregoing, with respect to Licensed Products that are
Combination Products, Net Sales in the Profit-Share Territory shall not be
reduced as set forth in the immediately preceding paragraph and the cost of
acquiring any other clinically active therapeutic or prophylactic ingredient or
other significant component, mechanism or device shall be included in the
calculation of the Cost of Goods Sold for purposes of calculating N.A. Pre-Tax
Profit or Loss for such Licensed Product in the Profit-Share Territory.
As used above, the term "Combination Product" means any pharmaceutical product
that consists of a Licensed Product and other active compounds or active
ingredients or other significant component, mechanism or device or any
combination of Licensed Product sold
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
14
together with another pharmaceutical product or other significant component,
mechanism or device for a single invoiced price, and the phrases "sold as part
of a Combination Product," "sold separately," "Net Sales of the Combination
Product" and "average sale price" refer to sales by Cubist or its Related
Parties in the applicable country.
All references to Licensed Product in this
Agreement shall be deemed to include Combination Product, to the extent
applicable.
SECTION 1.77
"NEW DRUG APPLICATION" OR "NDA".
NEW DRUG APPLICATION OR NDA
MEANS (A) AN APPLICATION SUBMITTED TO FDA PURSUANT TO 21 U.S.C. § 505(B), WHICH
CONTAINS COMPLETE DETAILS OF THE MANUFACTURE AND TESTING OF A NEW DRUG, FOR
PURPOSES OF OBTAINING REGULATORY APPROVAL FOR SUCH NEW DRUG IN THE UNITED
STATES, FOR A PARTICULAR INDICATION, AND ALSO INCLUDES ANY BIOLOGICS LICENSE
APPLICATION, OR (B) A SIMILAR APPLICATION, SUCH AS A MARKETING APPROVAL
AUTHORIZATION ("MAA") FILED WITH THE EMEA OR OTHER REGULATORY AUTHORITY.
SECTION 1.78
"NORTH AMERICA" OR "N.A.".
NORTH AMERICA OR N.A. MEANS THE UNITED
STATES, CANADA AND MEXICO.
SECTION 1.79
"PARTIES".
PARTIES MEANS ALNYLAM AND CUBIST.
SECTION 1.80
"PARTY".
PARTY MEANS EITHER ALNYLAM OR CUBIST.
SECTION 1.81
"PATENT-BASED EXCLUSIVITY PERIOD".
PATENT-BASED EXCLUSIVITY
PERIOD MEANS, WITH RESPECT TO A COUNTRY IN THE ROYALTY TERRITORY, THAT PERIOD OF
TIME DURING WHICH AT LEAST ONE VALID CLAIM WITHIN THE ALNYLAM PATENT RIGHTS
COVERS LICENSED PRODUCT IN SUCH COUNTRY.
SECTION 1.82
"PATENT RIGHTS".
PATENT RIGHTS MEANS PATENTS AND PATENT
APPLICATIONS AND ALL SUBSTITUTIONS, DIVISIONS, CONTINUATIONS,
CONTINUATIONS-IN-PART, REISSUES, REEXAMINATIONS, SUPPLEMENTAL PROTECTION
CERTIFICATES AND EXTENSIONS AND THE LIKE THEREOF, AND ALL COUNTERPARTS THEREOF
IN ANY COUNTRY.
SECTION 1.83
"PERSON".
PERSON MEANS ANY NATURAL PERSON, CORPORATION, FIRM,
BUSINESS TRUST, JOINT VENTURE, ASSOCIATION, ORGANIZATION, COMPANY, PARTNERSHIP
OR OTHER BUSINESS ENTITY, OR ANY GOVERNMENT, OR ANY AGENCY OR POLITICAL
SUBDIVISIONS THEREOF.
SECTION 1.84
"PHASE I CLINICAL STUDY".
PHASE I CLINICAL STUDY MEANS A CLINICAL
STUDY OF LICENSED PRODUCT IN HUMAN VOLUNTEERS OR PATIENTS WITH THE ENDPOINT OF
DETERMINING INITIAL TOLERANCE, TOXICITY, SAFETY OR PHARMACOKINETIC INFORMATION,
WHICH SHALL BE DEEMED COMMENCED WHEN THE THIRD VOLUNTEER OR PATIENT IN SUCH
STUDY HAS RECEIVED HIS OR HER INITIAL DOSE OF LICENSED PRODUCT.