LIMITED TO,
PRODUCT OR PROCESS SPECIFICATIONS, TESTING OR TEST METHODS, RAW MATERIAL
SPECIFICATIONS OR SUPPLIERS, EQUIPMENT, ETC.), RELATING TO THE PRODUCT.
3
1.36
"PRODUCT" SHALL MEAN ANY LICENSED PRODUCT (AS
DEFINED IN THE LICENSE AGREEMENT).
1.37
"PURCHASE ORDER" SHALL MEAN A WRITTEN PURCHASE
ORDER DELIVERED BY LICENSEE TO ACORDA FOR PRODUCTS PURSUANT TO THIS AGREEMENT.
1.38
"QUALITY AGREEMENT" SHALL MEAN A QUALITY
AGREEMENT ENTERED INTO BY ACORDA AND LICENSEE, OR BY LICENSEE AND A THIRD PARTY
MANUFACTURER, AS DESCRIBED IN SECTION 3.3.
1.39
"REGULATORY AUTHORITY" SHALL MEAN ANY APPLICABLE
GOVERNMENT REGULATORY AUTHORITY INVOLVED IN GRANTING APPROVALS FOR THE MARKETING
AND COMMERCIAL SALE OF A PHARMACEUTICAL OR BIOLOGICAL PRODUCT OR MEDICAL DEVICE
IN A COUNTRY OR REGULATORY JURISDICTION (INCLUDING PRICING AND/OR REIMBURSEMENT
APPROVAL IN ANY COUNTRY IN WHICH PRICING AND/OR REIMBURSEMENT APPROVAL IS
REQUIRED BY APPLICABLE LAWS), INCLUDING THE FDA, THE EMEA AND FOREIGN
EQUIVALENTS THEREOF.
1.40
"SECOND SOURCE AGREEMENT" SHALL HAVE THE MEANING
SET FORTH IN SECTION 8.3(B).
1.41
"SEMI-FIRM PERIOD" SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.1(A).
1.42
"SEVERED CLAUSE" SHALL HAVE THE MEANING SET FORTH
IN SECTION 12.8.
1.43
"SPECIFICATIONS" SHALL MEAN (A) WITH RESPECT TO
THE BULK LICENSED PRODUCT, THE SPECIFICATIONS FOR THE BULK LICENSED PRODUCT, AS
DETERMINED PURSUANT TO THE ELAN SUPPLY AGREEMENT AND SECTION 6.3 OF THE ELAN
LICENSE AGREEMENT AND AS MAY BE AMENDED IN ACCORDANCE WITH SECTION 5.1 OF THIS
AGREEMENT, AND (B) WITH RESPECT TO THE PACKAGING AND LABELING FOR ORDERS OF THE
LICENSED PRODUCT FOR SALE IN A PARTICULAR COUNTRY IN THE TERRITORY, THE
SPECIFICATIONS THEREFOR MUTUALLY AGREED UPON BY THE PARTIES IN ACCORDANCE WITH
SECTION 5.1(B).
1.44
"SUPPLY SHORTAGE" SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.7.
1.45
"TERM" SHALL HAVE THE MEANING SET FORTH IN
SECTION 10.1.
1.46
"THIRD PARTY" SHALL MEAN ANY PERSON WHO IS NOT A
PARTY OR AN AFFILIATE UNDER THIS AGREEMENT.
1.47
"TRANSFER PRICE" SHALL MEAN THE PRICE ACORDA'S
THIRD PARTY MANUFACTURER(S) INVOICES ACORDA FOR PRODUCT MANUFACTURED BY SUCH
THIRD PARTY MANUFACTURER(S) SUPPLIED TO LICENSEE PURSUANT TO THE
AGREEMENT(S) BETWEEN ACORDA AND SUCH MANUFACTURER(S).
1.48
CONSTRUCTION.
IN CONSTRUING THIS AGREEMENT,
UNLESS EXPRESSLY SPECIFIED OTHERWISE;
(A)
REFERENCES TO SECTIONS AND EXHIBITS ARE TO
SECTIONS OF, AND EXHIBITS TO, THIS AGREEMENT;
(B)
EXCEPT WHERE THE CONTEXT OTHERWISE REQUIRES,
USE OF EITHER GENDER INCLUDES THE OTHER GENDER, AND USE OF THE SINGULAR INCLUDES
THE PLURAL AND VICE VERSA;
4
(C)
HEADINGS AND TITLES ARE FOR CONVENIENCE
ONLY AND DO NOT AFFECT THE INTERPRETATION OF THIS AGREEMENT;
(D)
ANY LIST OR EXAMPLES FOLLOWING THE WORD
"INCLUDING" SHALL BE INTERPRETED WITHOUT LIMITATION TO THE GENERALITY OF THE
PRECEDING WORDS;
(E)
EXCEPT WHERE THE CONTEXT OTHERWISE
REQUIRES, THE WORD "OR" IS USED IN THE INCLUSIVE SENSE;
(F)
ALL REFERENCES TO "DOLLARS" OR "$" HEREIN
SHALL MEAN U.S. DOLLARS; AND
(G)
EACH PARTY REPRESENTS THAT IT HAS BEEN
REPRESENTED BY LEGAL COUNSEL IN CONNECTION WITH THIS AGREEMENT AND ACKNOWLEDGES
THAT IT HAS PARTICIPATED IN THE DRAFTING HEREOF.
IN INTERPRETING AND APPLYING
THE TERMS AND PROVISIONS OF THIS