(AS THE CASE MAY BE) CONSOLIDATED AND CONSOLIDATING FINANCIAL
STATEMENTS PREPARED IN ACCORDANCE WITH GENERALLY ACCEPTED ACCOUNTING PRINCIPLES.
THE FIRST SALE TO A THIRD PARTY IN AN ARMS-LENGTH TRANSACTION SHALL BE REGARDED
AS THE FIRST SALE FOR THE PURPOSE OF CALCULATING NET SALES.
SECTION 1.12
"NDA" MEANS A NEW DRUG APPLICATION
AND AMENDMENTS THERETO FILED PURSUANT TO THE REQUIREMENTS OF THE FDA, AS DEFINED
IN 21 C.F.R. § 314 ET SEQ., FOR FDA APPROVAL OF A NEW DRUG PRODUCT.
SECTION 1.13
"ORDER" MEANS ANY WRIT, JUDGMENT,
DECREE, INJUNCTION, AWARD OR SIMILAR ORDER OF ANY GOVERNMENTAL AUTHORITY,
INCLUDING ANY AWARD IN AN ARBITRATION PROCEEDING (IN EACH CASE, WHETHER
PRELIMINARY OR FINAL).
SECTION 1.14
"PARTIES" MEANS THE PURCHASER AND
THE COMPANY.
SECTION 1.15
"PARTY" MEANS THE PURCHASER OR THE
COMPANY, AS THE CONTEXT MAY REQUIRE.
SECTION 1.16
"PATENT RIGHTS" MEANS UNITED STATES
AND FOREIGN PATENTS AND PATENT APPLICATIONS AND ALL SUBSTITUTIONS, DIVISIONS,
CONTINUATIONS, CONTINUATIONS-IN-PART, REQUESTS FOR CONTINUED EXAMINATIONS,
REISSUES, REEXAMINATIONS AND EXTENSIONS THEREOF.
SECTION 1.17
"PERSON" MEANS ANY NATURAL PERSON OR
ANY CORPORATION, COMPANY, PARTNERSHIP, JOINT VENTURE, FIRM OR OTHER ENTITY,
INCLUDING WITHOUT LIMITATION A PARTY.
SECTION 1.18
"PRODUCT" AND COGNATES THEREOF MEAN
CELECOXIB IN ALL DELIVERY METHODS, FORMULATIONS AND DOSAGES.
*CONFIDENTIAL TREATMENT REQUESTED
3
SECTION 1.19
"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 1.20
"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 1.21
"PRODUCT PAYMENTS" MEANS THE UPFRONT
LICENSE PAYMENT AND THE REGULATORY MILESTONE PAYMENT.
SECTION 1.22
"REGULATORY MILESTONE PAYMENT" HAS
THE MEANING ASCRIBED TO SUCH TERM IN SECTION 2.11.
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 2.11.
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