THE CLAIMS OF, PCT PATENT
APPLICATION NO. PCT/US06/001887 (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE)
(THE "PHARMANOVA PRODUCT PATENT APPLICATION").
2.24
"PHASE III CLINICAL STUDIES" MEANS CONTROLLED
HUMAN CLINICAL STUDIES INVOLVING ADMINISTRATION OF A DRUG WITH THE GOAL OF
ESTABLISHING THAT A DRUG IS SAFE AND EFFICACIOUS FOR ITS INTENDED USE, AND TO BE
CONSIDERED AS A PIVOTAL STUDY OR STUDIES FOR SUBMISSION OF AN NDA.
2.25
"PRODUCT" MEANS ANY PHARMACEUTICAL PRODUCT
CONTAINING API AS AN ACTIVE PHARMACEUTICAL INGREDIENT SUCH THAT THE DEVELOPMENT,
MANUFACTURE, SALE OR USE OF SUCH PRODUCT FOR THE MENOPAUSE INDICATIONS WOULD,
BUT FOR THE LICENSE GRANTED UNDER THIS AGREEMENT, INFRINGE IN THE TERRITORY A
VALID CLAIM OF A LICENSED PATENT.
PRODUCT DOES NOT INCLUDE PHARMANOVA PRODUCTS
NOR ANY PRODUCT THAT IS COMMERCIALIZED IN THE TERRITORY BUT IS NOT EXPRESSLY
LABELED OR MARKETED FOR THE MENOPAUSE INDICATIONS.
2.26
"PROGRAM" MEANS ALL ACTIVITIES RELATED TO THE
DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT PERFORMED BY OR ON BEHALF OF
LICENSEE (OR ITS AFFILIATES) OR LICENSOR (OR ITS AFFILIATES) PURSUANT TO THIS
AGREEMENT; PROVIDED, HOWEVER, THAT ALL ACTIVITIES RELATED TO THE DEVELOPMENT OF
PRODUCTS CONDUCTED BY LICENSEE (OR ITS AFFILIATES) PRIOR TO THE EFFECTIVE DATE
WILL BE DEEMED TO BE CONDUCTED OUTSIDE OF THE PROGRAM.
2.27
"QUARTER" MEANS EACH OF THE THREE-MONTH PERIODS
ENDING ON MARCH 31, JUNE 30, SEPTEMBER 30 AND DECEMBER 31 IN ANY CALENDAR YEAR.
2.28
"REGULATORY APPROVAL" MEANS IN THE UNITED STATES,
WRITTEN NOTICE OF MARKETING APPROVAL BY THE FDA BASED ON APPROVAL OF AN NDA AND
SATISFACTION OF ANY RELATED APPLICABLE FDA REGISTRATION AND NOTIFICATION
REQUIREMENTS (IF ANY) WHICH ARE REQUIRED BEFORE A PRODUCT MAY BE COMMERCIALLY
SOLD IN THE UNITED STATES.
6
2.29
"REGULATORY DATA" MEANS ANY INFORMATION AND DATA
NECESSARY OR USEFUL TO OBTAIN OR MAINTAIN REGULATORY APPROVAL FOR THE PRODUCT IN
THE TERRITORY, INCLUDING POST-APPROVAL REPORTS, FILINGS AND SUBMISSION AND SHALL
INCLUDE, BUT NOT BE LIMITED TO, ANY CLINICAL INFORMATION REQUIRED FOR THAT
PURPOSE.
2.30
"SUBLICENSE" MEANS THE PRESENT, FUTURE OR
CONTINGENT TRANSFER OF ANY LICENSE, RIGHT, OPTION, FIRST RIGHT TO NEGOTIATE OR
OTHER RIGHT GRANTED UNDER THE LICENSOR PATENT RIGHTS IN WHOLE OR IN PART
PURSUANT TO SECTION 4.2; PROVIDED, HOWEVER, THAT THE DEVELOPMENT, PROMOTION,
DISTRIBUTION OR MARKETING OF THE PRODUCT BY A THIRD PARTY ON BEHALF OF LICENSEE
DOES NOT CONSTITUTE A SUBLICENSE.
2.31
"SUBLICENSEE" MEANS A THIRD PARTY THAT IS GRANTED
A SUBLICENSE.
2.32
"TERRITORY" MEANS UNITED STATES OF AMERICA AND
ITS TERRITORIES INCLUDING PUERTO RICO.
2.33
"THIRD PARTY" MEANS ANY INDIVIDUAL, ESTATE,
TRUST, PARTNERSHIP, JOINT VENTURE, ASSOCIATION, FIRM, CORPORATION, COMPANY OR
OTHER ENTITY, OTHER THAN LICENSOR OR LICENSEE OR ANY OF THEIR AFFILIATES.
2.34
"UNIVERSITY" MEANS THE UNIVERSITY OF ROCHESTER,
LOCATED IN ROCHESTER, NEW YORK.
2.35
"UNIVERSITY LICENSE" MEANS THE EXCLUSIVE PATENT
LICENSE AGREEMENT, DATED AUGUST 11, 2004, BETWEEN LICENSOR AND UNIVERSITY, AS
AMENDED BY AMENDMENT NO. 1 THERETO DATED AS OF THE EFFECTIVE DATE, AND AS MAY BE
SUBSEQUENTLY AMENDED IN ACCORDANCE WITH THIS AGREEMENT.
2.36
"UNIVERSITY PROVISIONS" MEANS THE FOLLOWING
PROVISIONS OF THIS AGREEMENT:
SECTION 4.2 (SUBLICENSING);