CITY OR OTHER POLITICAL SUBDIVISION.
2.16
"LAW" OR "LAWS" MEANS ALL LAWS, STATUTES, RULES,
REGULATIONS, ORDERS, JUDGMENTS AND/OR ORDINANCES OF ANY GOVERNMENT AUTHORITY.
2.17
"LICENSED PATENT" MEANS THE '098 PATENT.
2.18
"LICENSOR PATENT RIGHTS" MEANS ANY PATENT RIGHTS,
INCLUDING WITHOUT LIMITATION THOSE RIGHTS IN THE LICENSED PATENT GRANTED TO AND
HELD BY LICENSOR UNDER THE UNIVERSITY LICENSE, IN THE FIELD OF USE OF API FOR
MENOPAUSE INDICATIONS, WHICH RIGHTS ARE OWNED BY OR CONTROLLED BY LICENSOR OR AN
AFFILIATE OF LICENSOR AS OF THE EFFECTIVE DATE; PROVIDED, HOWEVER, THAT LICENSOR
PATENT RIGHTS SHALL NOT INCLUDE THE PHARMANOVA PATENT APPLICATION OR ANY PATENT
RIGHTS ASSOCIATED THEREWITH.
ALL LICENSOR PATENT RIGHTS CURRENTLY WITHIN THIS
DEFINITION ARE SET FORTH ON EXHIBIT A, WHICH EXHIBIT SHALL BE AMENDED FROM TIME
TO TIME AS NECESSARY TO REFLECT CHANGES OR ADDITIONS TO THE LICENSOR PATENT
RIGHTS.
4
2.19
"MENOPAUSE INDICATIONS" MEANS THE TREATMENT,
DIAGNOSIS OR PREVENTION OF VASOMOTOR SYMPTOMS OF HORMONAL VARIATION (E.G., HOT
FLASHES) ASSOCIATED WITH MENOPAUSE IN WOMEN.
2.20
"NDA" MEANS A NEW DRUG APPLICATION FILED WITH THE
FDA WITH RESPECT TO A PHARMACEUTICAL PRODUCT (OR SIMILAR APPLICATION, IF SUCH
APPLICATION IS NO LONGER AVAILABLE OR APPROPRIATE).
2.21
"NET SALES" MEANS THE GROSS AMOUNT OF MONIES OR
CASH EQUIVALENT OR OTHER CONSIDERATION THAT IS PAID BY THIRD PARTIES TO LICENSEE
OR ANY OF ITS AFFILIATES, ASSIGNEES, LICENSEES, SUBLICENSEES, TRANSFEREES,
DISTRIBUTORS OR COMMERCIAL PARTNERS (OR THEIR AFFILIATES) OR DESIGNEES THEREOF
FOR PRODUCT BY SALE OR OTHER MODE OF TRANSFER, IN BONA FIDE ARM'S LENGTH
TRANSACTIONS, LESS THE FOLLOWING DEDUCTIONS, IN EACH CASE RELATED SPECIFICALLY
TO PRODUCT AND ACTUALLY ALLOWED AND CUSTOMARILY TAKEN BY SUCH THIRD PARTIES AND
NOT OTHERWISE RECOVERED BY OR REIMBURSED TO LICENSEE OR ANY OF ITS AFFILIATES,
ASSIGNEES, LICENSEES, SUBLICENSEES, TRANSFEREES, DISTRIBUTORS OR COMMERCIAL
PARTNERS (OR THEIR AFFILIATES) OR DESIGNEES THEREOF:
(I) ALL TRADE, QUANTITY
AND CASH DISCOUNTS ACTUALLY ALLOWED AND CUSTOMARILY TAKEN; (II) CUSTOMARY AND
USUAL CREDITS, AND ALLOWANCES ACTUALLY GRANTED AND TAKEN ON ACCOUNT OF
REJECTIONS, RETURNS OR BILLING ERRORS; (III) PACKING COSTS; (IV) TRANSPORTATION;
AND, (V) INSURANCE, SOLELY RELATED TO SHIPPING SUCH PRODUCT EXCEPT THAT NO
DEDUCTIONS MAY BE MADE FOR COMMISSIONS PAID TO INDIVIDUALS WHETHER THEY BE WITH
INDEPENDENT SALES AGENCIES OR REGULARLY EMPLOYED BY LICENSEE, ITS AFFILIATES OR
SUBLICENSEES, AND ON ITS PAYROLL.
2.22
"PATENT RIGHTS" SHALL MEAN (I) VALID AND
ENFORCEABLE PATENTS, RE-EXAMINATIONS, REISSUES, RENEWALS, EXTENSIONS,
SUPPLEMENTARY PROTECTION CERTIFICATES AND TERM RESTORATIONS, ANY CONFIRMATION
PATENT OR REGISTRATION PATENT OR PATENT OF ADDITION BASED ON ANY SUCH PATENT,
(II) PENDING APPLICATIONS FOR PATENTS, INCLUDING WITHOUT LIMITATION
CONTINUATIONS, CONTINUATIONS-IN-PART, DIVISIONAL, PROVISIONAL AND SUBSTITUTE
APPLICATIONS, AND INVENTORS' CERTIFICATES, AND (III) ALL PRIORITY APPLICATIONS
OF ANY OF THE FOREGOING.
5
2.23
"PHARMANOVA PRODUCT" MEANS ANY PHARMACEUTICAL
PRODUCT CONTAINING API AS AN ACTIVE PHARMACEUTICAL INGREDIENT SUCH THAT (I) THE
DEVELOPMENT, MANUFACTURE, SALE OR USE OF SUCH PRODUCT IN THE TERRITORY WOULD BE
COVERED BY A VALID CLAIM OF A LICENSED PATENT, AND (II) SUCH PRODUCT OR ITS USE
IS DESCRIBED IN, OR IS COVERED BY ONE OR MORE OF