connection with the Development (other than Commercial Scale Validation Costs)
of such Product for commercialization in the relevant Territory (including,
without limitation, Controlled Contractors in connection with the Development of
such Product) which, with respect to such costs that are borne in whole or in
part by the other Party, are incurred in accordance with the relevant Annual
Collaboration Plan.
Development Costs do not include:
(a) Momenta Third Party
Royalty Obligations; (b) Third Party Royalties; (c) Commercialization Costs; (d)
Product-Specific Patent Costs or other patent costs allocated pursuant to
Article 8; (e) Legal Expenses; (f) amounts relating to the development of the
Lovenox-Referenced Product in the U.S. Territory; or (g) Commercial Scale
Validation Costs.
1.31.
"EMEA".
EMEA means The European Agency for the Evaluation of
Medicinal Products.
1.32.
"[**]-EQUIVALENT PRODUCT".
[**]-EQUIVALENT PRODUCT MEANS (A) [**]
IN INJECTABLE FORM SOLD AS A BRAND, INCLUDING [**] USING ANOTHER TRADENAME
(COLLECTIVELY, "BRANDED [**]"), OR
7
(B) ANY INJECTABLE PRODUCT SOLD IN THE U.S. TERRITORY (OTHER THAN BRANDED [**])
THAT IS A GENERIC A-RATED THERAPEUTICALLY EQUIVALENT TO [**] IN INJECTABLE
FORM.
FOR THE AVOIDANCE OF DOUBT, AN [**]-EQUIVALENT PRODUCT EXCLUDES ANY NEW
CHEMICAL ENTITIES.
THE PARTIES AGREE THAT THE PRODUCT SOLD AS THE BRAND [**]
SHALL NOT BE CONSIDERED AN [**]-EQUIVALENT PRODUCT.
1.33.
"[**] PRODUCT-SPECIFIC PATENT RIGHTS".
[**] PRODUCT-SPECIFIC
PATENT RIGHTS MEANS THOSE SANDOZ PRODUCT-SPECIFIC PATENT RIGHTS, MOMENTA
PRODUCT-SPECIFIC PATENT RIGHTS AND JOINT PRODUCT-SPECIFIC PATENT RIGHTS THAT
SOLELY RELATE TO THE [**]-REFERENCED PRODUCT AND DO NOT RELATE TO, AND CANNOT
REASONABLY BE USED WITH, ANY OTHER PRODUCT OR FOR ANY GENERAL PURPOSE.
1.34.
"[**]-REFERENCED PRODUCT".
[**]-REFERENCED PRODUCT MEANS
INJECTABLE [**] FOR WHICH THE REFERENCE LISTED DRUG IS [**] AS LISTED IN U.S.
BIOLOGIC LICENSE APPLICATION NO. [**] AND FOR WHICH AN APPLICATION COULD BE
APPROVED BY THE FDA FOR THE U.S. TERRITORY AND WHICH PRODUCT HAS (A) [**], (B)
[**], AND (C) [**].
FOR THE AVOIDANCE OF DOUBT, [**]-REFERENCED PRODUCT
EXCLUDES ANY NEW CHEMICAL ENTITIES.
FOR CLARITY, ANY PRODUCT FOR WHICH AN
APPLICATION CITING [**] AS THE REFERENCE LISTED DRUG COULD BE APPROVED SHALL NOT
BE CONSIDERED AN [**]-REFERENCED PRODUCT.
1.35.
"EQUITY AGREEMENTS".
EQUITY AGREEMENTS MEANS THE STOCK PURCHASE
AGREEMENT AND THE INVESTOR RIGHTS AGREEMENT.
1.36.
"EUROPEAN TERRITORY".
EUROPEAN TERRITORY MEANS (A) THE MEMBER
STATES OF THE EUROPEAN UNION, AS MAY BE REVISED FROM TIME TO TIME, AND (B)
ANDORRA, ICELAND, LIECHTENSTEIN, MONACO, NORWAY, SWITZERLAND, SAN MARINO AND
VATICAN CITY.
1.37.
"EXECUTIVE OFFICERS".
EXECUTIVE OFFICERS MEANS (A) WITH RESPECT TO
THE FIRST CONTRACT YEAR, THE CHIEF EXECUTIVE OFFICER OF SANDOZ AND THE CHIEF
EXECUTIVE OFFICER OF MOMENTA, AND (B) THEREAFTER, WITH RESPECT TO EACH PARTY,
(I) THE CHIEF EXECUTIVE OFFICER OF SUCH PARTY OR (II) A GLOBAL VICE-PRESIDENT
(OR OTHER TITLE) WHO REPORTS DIRECTLY TO THE CHIEF EXECUTIVE OFFICER OF SUCH
PARTY AND WHO IS NOT THEN A CO-CHAIR OF THE JSC OR JOC.
1.38.
"EXISTING US LOVENOX AGREEMENT".
EXISTING US LOVENOX AGREEMENT
MEANS THE COLLABORATION AND LICENSE AGREEMENT, DATED NOVEMBER 1, 2003, BY AND
AMONG MOMENTA, SANDOZ INC. AND SANDOZ AG (VIA