COMMERCIALLY IMPORTANT INDICATIONS THAT ARE INCLUDED IN THE
LABEL APPROVED BY A REGULATORY AUTHORITY IN THE TERRITORY FOR SUCH LICENSED
PRODUCT.
NOTWITHSTANDING THE FOREGOING, THE TERM "DIRECTLY COMPETITIVE PRODUCT"
SHALL NOT INCLUDE [*.]
1.35.
"DOLLAR" SHALL MEAN A UNITED STATES DOLLAR, AND "$" SHALL BE INTERPRETED
ACCORDINGLY.
1.36.
"DRUG APPROVAL APPLICATION" SHALL MEAN AN APPLICATION FOR REGULATORY
APPROVAL REQUIRED BEFORE COMMERCIAL SALE OR USE OF A LICENSED PRODUCT AS A DRUG
IN A REGULATORY JURISDICTION, INCLUDING WITHOUT LIMITATION AN NDA AND A
BIOLOGICS LICENSE APPLICATION (BLA) FILED IN THE UNITED STATES.
1.37.
"DRUG MASTER FILE," OR "DMF" SHALL MEAN A VOLUNTARY SUBMISSION THAT MAY
BE USED TO PROVIDE CONFIDENTIAL, DETAILED INFORMATION ABOUT THE ACTIVE
PHARMACEUTICAL INGREDIENT, DAPTOMYCIN, AND FACILITIES, PROCESSES OR ARTICLES
USED DURING THE MANUFACTURING, PROCESSING, PACKAGING AND STORING OF DAPTOMYCIN
OR ONE OR MORE OTHER DRUG PRODUCTS.
1.38.
"EFFECTIVE DATE THIRD PARTY LICENSES" SHALL HAVE THE MEANING ASSIGNED TO
SUCH TERM IN SECTION 8.7(A).
1.39.
"EMEA" SHALL MEAN THE EUROPEAN MEDICINES EVALUATION AGENCY, OR ANY
SUCCESSOR THERETO, WHICH COORDINATES THE SCIENTIFIC REVIEW OF HUMAN
PHARMACEUTICAL PRODUCTS UNDER THE CENTRALIZED LICENSING PROCEDURES OF THE
EUROPEAN COMMUNITY.
1.40.
"FAIR MARKET VALUE" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 2.12 HEREOF.
1.41.
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG ADMINISTRATION, OR ANY
SUCCESSOR THERETO.
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
6
1.42.
"GLOBAL HARM" SHALL MEAN [*].
1.43.
"IND" SHALL MEAN AN INVESTIGATIONAL NEW DRUG APPLICATION.
1.44.
"INDEMNIFY" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN SECTION 10.1
HEREOF.
1.45.
"INFORMATION" SHALL MEAN (I) TECHNIQUES, INFORMATION AND DATA
SPECIFICALLY RELATING TO DEVELOPMENT, MANUFACTURE, USE, SALE, IMPORT OR EXPORT
OF LICENSED PRODUCTS, INCLUDING, BUT NOT LIMITED TO, INVENTIONS, PRACTICES,
METHODS, KNOWLEDGE, KNOW-HOW, SKILL, EXPERIENCE, TEST DATA INCLUDING
PHARMACOLOGICAL, TOXICOLOGICAL AND CLINICAL TEST DATA, ANALYTICAL AND QUALITY
CONTROL DATA, REGULATORY SUBMISSIONS, CORRESPONDENCE AND COMMUNICATIONS,
MARKETING, PRICING, DISTRIBUTION, COST, SALES, MANUFACTURING, PATENT AND LEGAL
DATA OR DESCRIPTIONS AND (II) COMPOSITIONS OF MATTER, ASSAYS AND BIOLOGICAL
MATERIALS SPECIFICALLY RELATING TO DEVELOPMENT, MANUFACTURE, USE, SALE, IMPORT
OR EXPORT OF LICENSED PRODUCTS.
1.46.
"INFRINGEMENT" OR "INFRINGE" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM
IN SECTION 8.4(A) HEREOF.
1.47.
"INJECTION" SHALL MEAN ALL MEANS OF DELIVERING A PHARMACEUTICAL
COMPOSITION BY INJECTION AND INCLUDES, WITHOUT LIMITATION, DELIVERY BY
INTRAVENOUS, INTRAMUSCULAR AND SUBCUTANEOUS INJECTION.
1.48.
"JOINT COORDINATION TEAM" OR "JCT" SHALL MEAN THE COMMITTEE FORMED AS
DESCRIBED IN SECTION 3.2(A).
1.49.
"JOINT INVENTIONS" SHALL HAVE THE MEANING ASSIGNED IN SECTION 8.1.
1.50.
"JOINT KNOW-HOW" SHALL MEAN ALL INFORMATION THAT (I) CONSISTS OF JOINT
INVENTIONS, (II) IS NOT GENERALLY KNOWN AND IS NOT DISCLOSED IN ANY PUBLISHED
JOINT PATENTS, AND (III) IS NECESSARY OR USEFUL IN CONNECTION WITH THE
DEVELOPMENT, MANUFACTURE, MARKETING, PROMOTION, USE, SALE, IMPORT OR EXPORT OF
LICENSED PRODUCTS, INCLUDING, WITHOUT LIMITATION, ALL DATA AND INFORMATION
REGARDING THE SAFETY AND EFFICACY OF LICENSED PRODUCTS.
1.51.
"JOINT PATENTS" SHALL HAVE THE MEANING ASSIGNED SUCH TERM IN SECTION
8.2(C).
1.52.
"JOINT TECHNOLOGY" SHALL MEAN ALL