DOSAGES.
SECTION 1.20
"PRODUCT CLINICAL DATA" MEANS ALL PRE-CLINICAL AND
CLINICAL DATA, DATABASES AND INTELLECTUAL PROPERTY RELATING TO THE PRODUCT AND
THE LICENSED PATENT RIGHTS, INCLUDING WITHOUT LIMITATION, RAW CASE REPORT FILES,
FINAL STUDY REPORTS, TOXICOLOGY REPORTS, REGULATORY INFORMATION INCLUDING ALL
INVESTIGATIONAL NEW DRUG APPLICATIONS AND SUCH OTHER INFORMATION AND DATA AS MAY
HAVE BEEN GENERATED DURING OR IN CONNECTION WITH ANY PRE-CLINICAL AND PHASE I
CLINICAL STUDIES OR OTHER STUDIES CONDUCTED ON THE PRODUCT OR WITH RESPECT TO
ANY LICENSED PATENT RIGHTS.
SECTION 1.21
"PRODUCT INTELLECTUAL PROPERTY" MEANS ALL PRODUCT
CLINICAL DATA, LICENSED PATENT RIGHTS AND LICENSED KNOW-HOW, AND ANY
IMPROVEMENTS TO ANY SUCH PRODUCT INTELLECTUAL PROPERTY TO THE EXTENT PERFORMED
BY THE COMPANY OR BY A THIRD PARTY AT THE COMPANY'S DIRECTION IN ACCORDANCE WITH
THE TERMS OF THIS AGREEMENT.
SECTION 1.22
"REGULATORY MILESTONE PAYMENT" HAS THE MEANING ASCRIBED
TO SUCH TERM IN SECTION 2.12.
SECTION 1.23
"REQUIREMENTS OF LAW" MEANS ANY LAW, STATUTE, CODE,
TREATY, ORDER, ORDINANCE, RULE, REGULATION OR OTHER REQUIREMENT PROMULGATED OR
ENACTED BY ANY GOVERNMENTAL AUTHORITY.
SECTION 1.24
"ROYALTY" HAS THE MEANING ASCRIBED TO SUCH TERM IN
SECTION 2.13.
SECTION 1.25
"TAX" AND COGNATES THEREOF MEAN ALL OF THE FOLLOWING:
(I) ANY SALES, USE AD VALOREM, TRANSFER, FRANCHISE, LICENSE, EXCISE, STAMP,
PRODUCTION, WITHHOLDING, VALUE ADDED, ENVIRONMENTAL, OR OTHER TAX, CUSTOM OR
DUTY OR GOVERNMENTAL FEE OR OTHER LIKE ASSESSMENT OR CHARGE TO THE EXTENT
DIRECTLY RELATED TO THE SALE OF PRODUCTS (THEREBY EXPLICITLY EXCLUDING ANY
INCOME, EMPLOYMENT OR PROFITS TAX OR ANY SORT) THAT MAY BE IMPOSED BY ANY
GOVERNMENTAL AUTHORITY FOR SUCH SALE OF PRODUCTS AND (II) ANY LIABILITY FOR THE
PAYMENT OF AMOUNTS DESCRIBED IN (I) ABOVE AS A RESULT OF BEING A MEMBER OF AN
AFFILIATED, CONSOLIDATED, COMBINED OR UNITARY GROUP FOR ANY TAXABLE PERIOD.
SECTION 1.26
"TERRITORY" MEANS WORLDWIDE, EXCEPT FOR ALBANIA, ANDORRA,
ARMENIA, AUSTRIA, AZERBAIJAN, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA,
BULGARIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE,
GEORGIA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, KAZAKHSTAN,
KYRGYZSTAN, LATVIA, LIECHTENSTEIN, LITHUANIA, LUXEMBOURG, MALTA, MONACO,
NETHERLANDS, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVA, ROMANIA, RUSSIAN
FEDERATION, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, THE FORMER YUGOSLAV
REPUBLIC OF MACEDONIA, TURKEY, TADZHIKISTAN, TURKMENISTAN, UKRAINE, UZBEKISTAN,
UNITED KINGDOM AND YUGOSLAVIA.
SECTION 1.27
"THIRD PARTY"
MEANS ANY PERSON OR ENTITY OTHER THAN A
PARTY OR ANY OF ITS AFFILIATES.
*CONFIDENTIAL TREATMENT REQUESTED
4
SECTION 1.28
"VALID CLAIM" MEANS A CLAIM OF ANY ISSUED, UNEXPIRED
UNITED STATES OR FOREIGN PATENT, WHICH SHALL NOT HAVE BEEN DONATED TO THE
PUBLIC, DISCLAIMED, NOR HELD INVALID OR UNENFORCEABLE BY A COURT OF COMPETENT
JURISDICTION IN AN UNAPPEALED OR UNAPPEALABLE DECISION.
ARTICLE II
GRANT OF LICENSE; DISCLOSURE OF KNOW-HOW; CLINICAL DATA
SECTION 2.1
LICENSE GRANT.
SUBJECT TO THE TERMS AND CONDITIONS OF
THIS AGREEMENT, THE COMPANY HEREBY GRANTS TO THE PURCHASER THE EXCLUSIVE,
IRREVOCABLE RIGHT AND LICENSE UNDER THE LICENSED PATENT RIGHTS AND THE LICENSED
KNOW-HOW IN THE FIELD IN THE TERRITORY, INCLUDING WITHOUT LIMITATION, TO
DEVELOP, MAKE, HAVE MADE, USE, OFFER FOR SALE, SELL AND IMPORT PHARMACEUTICAL
FORMULATIONS