AND 211 OF THE CFR, AS ESTABLISHED BY FDA OR AS SET
FORTH IN ANALOGOUS FOREIGN LAWS OR FOREIGN REGULATIONS AS ESTABLISHED BY FOREIGN
REGULATORY AUTHORITIES, AS APPLICABLE.
1.8.
"CHARACTERIZE" OR "CHARACTERIZATION".
CHARACTERIZE OR
CHARACTERIZATION, WITH RESPECT TO A PRODUCT, MEANS CHEMICAL, PHYSICAL AND
BIOLOGICAL CHARACTERIZATION OF SUCH PRODUCT AND THE APPLICABLE REFERENCE DRUG
WITH SUFFICIENT SPECIFICITY, AND DOCUMENTATION THEREOF AS IS NECESSARY TO
ESTABLISH TO THE SATISFACTION OF THE RELEVANT REGULATORY AUTHORITY IN THE
RESPECTIVE TERRITORY THAT THE ACTIVE INGREDIENT OF SUCH PRODUCT IS THE SAME AS
THAT OF THE APPLICABLE REFERENCE DRUG, AS REQUIRED TO SUBMIT AN APPLICATION.
2
1.9.
"CHANGE IN CONTROL".
CHANGE IN CONTROL MEANS, WITH RESPECT TO A
PARTY, THE CLOSING OF A TENDER OFFER, STOCK PURCHASE, OTHER STOCK ACQUISITION,
MERGER, CONSOLIDATION, RECAPITALIZATION, REVERSE SPLIT, SALE OR TRANSFER OF
ASSETS OR OTHER TRANSACTION (A "TRANSACTION"), AS A RESULT OF WHICH ANY PERSON
OR GROUP (AS SUCH TERM IS DEFINED UNDER SECTION 13(D) OF THE SECURITIES EXCHANGE
ACT OF 1934, AS AMENDED) (A) BECOMES THE BENEFICIAL OWNER, DIRECTLY OR
INDIRECTLY, OF SECURITIES OF SUCH PARTY REPRESENTING MORE THAN FIFTY PERCENT
(50%) OF THE COMMON STOCK OF SUCH PARTY OR REPRESENTING MORE THAN FIFTY PERCENT
(50%) OF THE COMBINED VOTING POWER WITH RESPECT TO THE ELECTION OF DIRECTORS (OR
MEMBERS OF ANY OTHER GOVERNING BODY) OF SUCH PARTY'S THEN OUTSTANDING
SECURITIES, (B) OBTAINS THE ABILITY TO APPOINT A MAJORITY OF THE BOARD OF
DIRECTORS (OR OTHER GOVERNING BODY) OF SUCH PARTY OR (C) OBTAINS THE ABILITY TO
DIRECT THE OPERATIONS OR MANAGEMENT OF SUCH PARTY OR ANY SUCCESSOR TO SUCH
PARTY'S BUSINESS, UNLESS, IMMEDIATELY FOLLOWING SUCH TRANSACTION, ALL OR
SUBSTANTIALLY ALL OF THE PERSONS AND GROUPS WHO WERE THE BENEFICIAL OWNERS OF
SUCH PARTY'S VOTING SECURITIES IMMEDIATELY PRIOR TO SUCH TRANSACTION
BENEFICIALLY OWN, DIRECTLY OR INDIRECTLY, MORE THAN FIFTY PERCENT (50%) OF THE
COMBINED VOTING SECURITIES OF THE RESULTING OR SURVIVING ENTITY IN SUCH
TRANSACTION; PROVIDED, HOWEVER, THAT A CHANGE IN CONTROL SHALL NOT RESULT FROM
ANY TRANSACTION THAT OCCURS SOLELY BETWEEN SUCH PARTY AND ANY ONE OR MORE OF ITS
THEN-CURRENT AFFILIATES.
1.10.
"COLLABORATION KNOW-HOW".
COLLABORATION KNOW-HOW MEANS SANDOZ
COLLABORATION KNOW-HOW, JOINT COLLABORATION KNOW-HOW AND MOMENTA COLLABORATION
KNOW-HOW.
1.11.
"COLLABORATION PRODUCT".
COLLABORATION PRODUCT MEANS EACH OF THE
COPAXONE-REFERENCED PRODUCT AND THE LOVENOX-REFERENCED PRODUCT.
1.12.
"COLLABORATION PRODUCT-SPECIFIC PATENT RIGHTS".
COLLABORATION
PRODUCT-SPECIFIC PATENT RIGHTS MEANS THE PRODUCT-SPECIFIC PATENT RIGHTS, OTHER
THAN [**] PRODUCT-SPECIFIC PATENT RIGHTS AND [**] PRODUCT-SPECIFIC PATENT
RIGHTS.
1.13.
"COLLABORATIVE PROGRAM".
COLLABORATIVE PROGRAM MEANS THE
DEVELOPMENT AND COMMERCIALIZATION OF, AND CONDUCT OF LEGAL ACTIVITIES WITH
RESPECT TO, THE PRODUCTS IN THE RELEVANT TERRITORIES, AS APPLICABLE, WITHIN THE
FIELD, UNDER THIS AGREEMENT AS DESCRIBED IN ARTICLES 5, 6 AND 7 AND IN THE
ANNUAL COLLABORATION PLANS.
1.14.
"COMMERCIAL SCALE VALIDATION COSTS".
COMMERCIAL SCALE VALIDATION
COSTS MEANS, WITH RESPECT TO A PRODUCT, EACH PARTY'S FTE COSTS, AND ALL
OUT-OF-POCKET COSTS PAID BY SANDOZ OR MOMENTA TO THIRD PARTIES AFTER THE
EFFECTIVE DATE, IN CONNECTION WITH VALIDATION OF COMMERCIAL SCALE PROCESS (FOR
DRUG SUBSTANCE AND DRUG PRODUCT, AS