UNINCORPORATED
ORGANIZATION OR GOVERNMENT OR POLITICAL SUBDIVISION THEREOF.
1.44
"PRIME RATE" SHALL MEAN THE AVERAGE PRIME RATE PUBLISHED IN THE WALL
STREET JOURNAL DURING THE RELEVANT PERIOD.
1.45
"PURCHASE AMOUNT" SHALL HAVE THE MEANING ASCRIBED TO IT IN SECTION 5.11
HEREOF.
1.46
"PURCHASE DOCUMENTATION" SHALL HAVE THE MEANING ASCRIBED TO IT IN
SECTION 5.11 HEREOF.
1.47
"REGULATORY APPROVAL" SHALL MEAN, WITH RESPECT TO ANY COUNTRY, ALL
AUTHORIZATIONS BY THE APPROPRIATE GOVERNMENTAL ENTITY OR ENTITIES NECESSARY FOR
COMMERCIAL SALE OF A DRUG PRODUCT IN THAT COUNTRY INCLUDING, WITHOUT LIMITATION
AND WHERE APPLICABLE, APPROVAL OF LABELING, PRICE, REIMBURSEMENT AND
MANUFACTURING. "REGULATORY APPROVAL" IN THE UNITED STATES SHALL MEAN FINAL
APPROVAL OF A NEW DRUG APPLICATION PURSUANT TO 21 CFR § 314, PERMITTING
MARKETING OF THE APPLICABLE DRUG PRODUCT IN INTERSTATE COMMERCE IN THE UNITED
STATES. "REGULATORY APPROVAL" IN THE EUROPEAN UNION SHALL MEAN FINAL APPROVAL OF
A MARKETING AUTHORIZATION APPLICATION, OR EQUIVALENT.
1.48
"RESEARCH INITIATION DATE" SHALL MEAN THE DATE ON WHICH THE RESEARCH PLAN
IS APPROVED THE PARTIES
1.49
"RESEARCH PLAN" SHALL HAVE THE MEANING SET FORTH IN SECTION 2.3 HEREOF.
1.50
"RESEARCH PROGRAM" SHALL MEAN ALL RESEARCH ACTIVITIES UNDERTAKEN UNDER
THIS
9
AGREEMENT ASSOCIATED WITH THE IDENTIFICATION AND DESIGN OF COMPOUNDS AND
CLINICAL DEVELOPMENT CANDIDATES AS PROVIDED HEREIN; INCLUDING BUT NOT LIMITED TO
THE IDENTIFICATION AND INITIAL TESTING OF COMPOUNDS; THE CONDUCT OF THOSE
ACTIVITIES REFERENCED IN THE CLINICAL DEVELOPMENT CANDIDATE CRITERIA WITH
RESPECT TO COMPOUNDS; SELECTION OF CLINICAL DEVELOPMENT CANDIDATES AND THE
PRESENTATION OF THOSE CLINICAL DEVELOPMENT CANDIDATES AND RELATED CLINICAL
DEVELOPMENT CANDIDATE INFORMATION TO CFFT.
1.51
"REVIEW PERIOD" SHALL HAVE THE MEANING ASCRIBED TO IT IN SECTION 5.11
HEREOF.
1.52
"TDN" SHALL MEAN THE THERAPEUTICS DEVELOPMENT NETWORK ESTABLISHED BY
CYSTIC FIBROSIS FOUNDATION THERAPEUTICS.
1.53
"TERM" SHALL MEAN THAT PERIOD SPECIFIED IN SECTION 10.1.
1.54
"TERRITORY" SHALL MEAN WORLDWIDE.
1.55
"TESTING REQUEST" SHALL HAVE THE MEANING ASCRIBED TO IT IN SECTION 2.7.3.
1.56
"THIRD PARTY" SHALL MEAN ANY PERSON OR ENTITY WHICH IS NOT A PARTY OR AN
AFFILIATE OF ANY PARTY TO THIS AGREEMENT.
1.57
"TRANSFER NOTICE" SHALL HAVE THE MEANING ASCRIBED TO IT IN SECTION 5.11.
1.58
"VALID CLAIM" MEANS A CLAIM IN A PENDING PATENT APPLICATION OR AN ISSUED
AND UNEXPIRED PATENT THAT (A) HAS NOT BEEN FINALLY CANCELLED, WITHDRAWN,
ABANDONED OR REJECTED BY ANY ADMINISTRATIVE AGENCY OR OTHER BODY OF COMPETENT
JURISDICTION NOT SUBJECT TO FURTHER APPEAL, (B) HAS NOT BEEN REVOKED, HELD
INVALID, OR DECLARED UNPATENTABLE OR UNENFORCEABLE IN A DECISION OF A COURT OR
OTHER BODY OF COMPETENT JURISDICTION THAT IS UNAPPEALABLE OR UNAPPEALED WITHIN
THE
10
TIME ALLOWED FOR APPEAL, (C) HAS NOT BEEN RENDERED UNENFORCEABLE THROUGH
DISCLAIMER, ABANDONMENT, WITHDRAWAL OR OTHERWISE, AND (D) WITH RESPECT TO A
CLAIM IN A PENDING PATENT APPLICATION, SUCH CLAIM IS BEING ACTIVELY PROSECUTED
IN GOOD FAITH AND IS BELIEVED IN GOOD FAITH TO MEET THE REQUIREMENTS OF
PATENTABILITY IN THE RELEVANT JURISDICTION.
ARTICLE II - RESEARCH PROGRAM
2.1
COMMENCEMENT; OBJECTIVE.
CombinatoRx will be responsible for the conduct of the Research Program and CFFT
will