THIS AGREEMENT SHALL PRECLUDE ACORDA FROM MAKING
ANY SUCH CHANGES.
(III)
NON-SPECIFIC OR JOINT CHANGES.
SUBJECT TO
SECTION 5.2(A), TO THE EXTENT THAT (A) CHANGES TO THE SPECIFICATIONS, PROCESSING
AND/OR FACILITY ARE REQUIRED PURSUANT TO LAW OR REGULATORY APPROVALS APPLICABLE
TO THE PRODUCT WORLDWIDE; (B) LICENSEE REQUESTS THAT A CHANGE MADE PURSUANT TO
SECTION 5.2(A)(II) BE ALSO MADE FOR THE PRODUCT IN THE TERRITORY; OR (C) ACORDA
REQUESTS THAT A CHANGE MADE PURSUANT TO SECTION 5.2(A)(I) BE ALSO MADE FOR THE
PRODUCT IN THE ACORDA TERRITORY, EACH PARTY SHALL PAY [*****] OF THE COSTS
INCURRED FOR SUCH CHANGES, BASED UPON THE MUTUALLY AGREED UPON ANTICIPATED SALES
OF PRODUCT, AS BETWEEN ACORDA AND LICENSEE, OVER THE NEXT [*****] PERIOD.
(b)
Notice of Required Changes.
If either Party
is notified of or otherwise learns of any change in Laws or Regulatory Approvals
in any country in which a Party and/or its Affiliates or Licensee's Third Party
Distributors are, or are reasonably anticipating, marketing or selling the
Product, which change would or could require a change to Specifications in such
*****Omitted pursuant to a confidential treatment request.
11
COUNTRY, THE NOTIFIED PARTY SHALL PROMPTLY NOTIFY THE OTHER PARTY OF SUCH CHANGE
IN LAWS OR REGULATORY APPROVALS AND, IF SUCH CHANGE WILL AFFECT THE PRODUCT IN
THE TERRITORY, THE PARTIES SHALL NEGOTIATE IN GOOD FAITH A WRITTEN AGREEMENT
REGARDING THE EXTENT AND TIMING OF SUCH CHANGE.
(C)
CHANGES REQUESTED BY LICENSEE.
NOTWITHSTANDING SECTION 5.1(A), IF LICENSEE, ON BEHALF OF ITSELF OR ANY OF ITS
AFFILIATES, REQUESTS ANY CHANGE TO SPECIFICATIONS WHICH IS NOT REQUIRED BY A
CHANGE IN LAWS OR REGULATORY APPROVALS IN ANY SUCH COUNTRY, ACORDA MAY, IN ITS
DISCRETION, CONSIDER SUCH REQUEST.
ACORDA SHALL CONSIDER SUCH REQUEST IN
ACCORDANCE WITH THE LICENSE AGREEMENT AS A PROPOSED AMENDMENT TO THE DEVELOPMENT
PLAN OR AS A DEVELOPMENT COLLABORATION PROPOSAL.
ALL COSTS WITH RESPECT THERETO
SHALL BE BORNE AS "DEVELOPMENT COSTS" IN ACCORDANCE WITH THE LICENSE AGREEMENT.
LICENSEE SHALL REASONABLY COOPERATE WITH ACORDA AND ITS THIRD PARTY
MANUFACTURERS IN OBTAINING ANY APPROVALS NECESSARY FOR SUCH REQUESTED CHANGES.
(D)
CHANGES TO THE PROCESS OR FACILITY.
LICENSEE ACKNOWLEDGES THAT ELAN HAS THE RIGHT TO CHANGE THE PROCESS OR FACILITY
PURSUANT TO SECTION 3.6 OF THE ELAN SUPPLY AGREEMENT.
5.3
Quality Assurance.
(A)
ACORDA SHALL USE COMMERCIALLY REASONABLE
EFFORTS TO OBTAIN FROM ITS THIRD PARTY MANUFACTURER(S) SUPPLYING PRODUCT FOR
LICENSEE REPRESENTATIONS AND WARRANTIES FOR THE BENEFIT OF LICENSEE THAT, AS OF
THE DATE OF PHYSICAL TRANSFER OF EACH ORDER OF PRODUCT TO LICENSEE, SUCH PRODUCT
(I) WAS MANUFACTURED IN ACCORDANCE WITH CGMP AND ALL APPLICABLE LAWS IN ALL
MATERIAL RESPECTS; (II) CONFORMS IN ALL MATERIAL RESPECTS TO THE APPLICABLE
SPECIFICATIONS; AND (III) DOES NOT CONTAIN ANY MATERIAL THAT WOULD CAUSE THE
PRODUCT TO BE ADULTERATED OR MISBRANDED UNDER APPLICABLE LAW.
(B)
DOCUMENTATION.
ACORDA OR ITS THIRD PARTY
MANUFACTURER SHALL DELIVER WITH EACH SHIPMENT OF PRODUCT (I) A CERTIFICATE OF
ANALYSIS FOR THE PRODUCT AND (II) THE BATCH RECORDS FOR SUCH PRODUCT (CLAUSES
(I) AND (II) OF