STABILITY AND OTHER PRODUCT TESTING AND DEVELOPMENT ACTIVITIES RELATING TO
QUALITY ASSURANCE AND QUALITY CONTROL, REGULATORY AFFAIRS ACTIVITIES AND PRODUCT
LIABILITY INSURANCE), WHICH COSTS SHALL INCLUDE, WITHOUT LIMITATION (A) THE COST
OF GOODS PRODUCED, WHICH COST SHALL INCLUDE [*****] AND/OR (B) ANY OTHER COSTS
BORNE BY THE MANUFACTURING PARTY FOR THE [*****].
SECTION 1.32
"GAAP".
GAAP SHALL MEAN UNITED STATES GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES.
SECTION 1.33
"GENERIC COMPETITION".
GENERIC COMPETITION SHALL MEAN,
WITH RESPECT TO A PRODUCT IN A GIVEN COUNTRY IN A GIVEN CALENDAR QUARTER, IF,
DURING SUCH CALENDAR QUARTER, ONE OR MORE GENERIC PRODUCTS SHALL BE COMMERCIALLY
AVAILABLE IN SUCH COUNTRY AND SUCH GENERIC PRODUCTS [*****].
SECTION 1.34
"GENERIC PRODUCT".
GENERIC PRODUCT SHALL MEAN ANY
PHARMACEUTICAL PRODUCT SOLD BY ANY PERSON FOR USE IN THE FIELD (OTHER THAN SALES
OF THE PRODUCT BY EITHER PARTY OR ITS RELATED PARTIES IN ACCORDANCE WITH THE
TERMS OF THIS AGREEMENT, WHETHER AS A BRANDED PRODUCT OR A GENERIC PRODUCT) THAT
CONTAINS [*****].
FOR PURPOSES OF THIS SECTION 1.33, ANOTHER COMPOUND WILL BE
CONSIDERED TO [*****].
SECTION 1.35
"IND".
IND SHALL MEAN AN INVESTIGATIONAL NEW DRUG
APPLICATION FILED WITH FDA OR A SIMILAR APPLICATION TO CONDUCT CLINICAL STUDIES
FILED WITH AN APPLICABLE REGULATORY AUTHORITY OUTSIDE OF THE UNITED STATES.
SECTION 1.36
"IN-LICENSE".
IN-LICENSE SHALL MEAN AN AGREEMENT BETWEEN
A PARTY AND A THIRD PARTY PURSUANT TO WHICH SUCH PARTY HAS (I) PURSUANT TO
SECTION 2.9, LICENSED BLOCKING THIRD PARTY PATENT RIGHTS WITH THE APPROVAL OF
THE JSC, OR (II) PURSUANT TO SECTION 2.8, LICENSED WITH THE APPROVAL OF THE JSC,
TECHNOLOGY OWNED OR CONTROLLED BY A COLLABORATOR THAT IS TO BE USED IN THE
DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF THE INITIAL FINISHED PRODUCT
SUBJECT TO, AND IN ACCORDANCE WITH, THE TERMS OF THIS AGREEMENT.
WITHOUT
LIMITING THE GENERALITY OF THE FOREGOING DEFINITION, THE [*****] LICENSE
AGREEMENT SHALL NOT BE TREATED FOR PURPOSES OF THIS AGREEMENT AS AN IN-LICENSE.
SECTION 1.37
"INVENTION".
INVENTION SHALL MEAN ANY KNOW-HOW THAT IS
CONCEIVED, REDUCED TO PRACTICE AND/OR DEVELOPED IN THE COURSE OF PERFORMANCE OF
ACTIVITIES PURSUANT TO THIS AGREEMENT.
* Confidential Treatment Requested.
Omitted portions filed with the Commission.
5
SECTION 1.38
"JOINT INTELLECTUAL PROPERTY".
JOINT INTELLECTUAL
PROPERTY SHALL MEAN JOINT KNOW-HOW AND JOINT PATENT RIGHTS, COLLECTIVELY.
SECTION 1.39
"JOINT KNOW-HOW".
JOINT KNOW-HOW SHALL MEAN ANY KNOW-HOW
THAT IS DEVELOPED OR ACQUIRED JOINTLY BY THE PARTIES IN CONNECTION WITH THEIR
ACTIVITIES PURSUANT TO THIS AGREEMENT, INCLUDING JOINT INVENTIONS.
SECTION 1.40
"JOINT PATENT RIGHTS".
JOINT PATENT RIGHTS SHALL MEAN
PATENT RIGHTS THAT COVER JOINT INVENTIONS.
SECTION 1.41
"KNOW-HOW".
KNOW-HOW SHALL MEAN ANY INFORMATION AND
MATERIALS, WHETHER PROPRIETARY OR NOT AND WHETHER PATENTABLE OR NOT, INCLUDING
WITHOUT LIMITATION IDEAS, CONCEPTS, INVENTIONS, FORMULAS, METHODS, PROTOCOLS,
PROCEDURES, KNOWLEDGE, KNOW-HOW, TRADE SECRETS, PROCESSES, ASSAYS, SKILLS,
EXPERIENCE, TECHNIQUES, DESIGNS, COMPOSITIONS, PLANS, DOCUMENTS, RESULTS OF
EXPERIMENTATION AND TESTING, INCLUDING WITHOUT LIMITATION, PHARMACOLOGICAL,
TOXICOLOGICAL, AND PRE-CLINICAL AND CLINICAL TEST DATA AND ANALYTICAL AND
QUALITY CONTROL DATA, IMPROVEMENTS, DISCOVERIES, WORKS OF AUTHORSHIP, COMPOUNDS
AND BIOLOGICAL MATERIALS.
SECTION 1.42
"MAJOR EUROPEAN COUNTRIES".
MAJOR EUROPEAN