GALDERMA
PURSUANT TO ITS REVIEW OF SUCH PLAN IS TO CONSIDER SUCH COMMENTS AND
OBSERVATIONS IN GOOD FAITH.
ARTICLE VII - SPECIFICATIONS; IMPROVEMENTS
7.1.
SPECIFICATIONS.
ANIKA AGREES THAT IT SHALL MANUFACTURE THE
LICENSED PRODUCTS IN ACCORDANCE WITH THE SPECIFICATIONS.
7.2.
CHANGE IN SPECIFICATIONS.
(A)
EITHER PARTY SHALL HAVE THE RIGHT TO REQUEST A CHANGE TO THE
SPECIFICATIONS DURING THE TERM.
IN SUCH EVENT, THE PARTY WISHING TO REQUEST A
CHANGE SHALL NOTIFY THE OTHER PARTY OF ITS REQUEST IN WRITING.
IF THE RECEIVING
PARTY AGREES TO SUCH REQUEST, THE PARTIES SHALL COOPERATE WITH EACH OTHER TO
HAVE SUCH CHANGE TO SUCH SPECIFICATIONS OR PACKAGING OF THE LICENSED PRODUCT
APPROVED BY THE FDA OR OTHER REGULATORY AGENCY (IF NECESSARY).
ANIKA SHALL NOT
BE OBLIGATED TO MAKE ANY CHANGES TO SUCH SPECIFICATIONS OF THE LICENSED PRODUCTS
REQUESTED BY GALDERMA, UNLESS SUCH CHANGES ARE APPROVED BY THE STEERING
COMMITTEE IN ACCORDANCE WITH THE LICENSE AGREEMENT.
IN THE CASE OF ANY APPROVED
CHANGES TO SPECIFICATIONS OF THE LICENSED PRODUCTS REQUESTED BY GALDERMA OR
REQUIRED BY THE FDA OR OTHER REGULATORY AGENCY, GALDERMA SHALL REIMBURSE ANIKA
FOR ALL ANIKA'S REASONABLE AND REASONABLY DOCUMENTED COSTS RELATED TO SUCH
CHANGES TO SPECIFICATIONS, INCLUDING WITHOUT LIMITATION COSTS ASSOCIATED WITH UP
TO SIX (6) MONTHS (DETERMINED BY REFERENCE TO THE FORECAST THEN IN EFFECT FOR
THE LICENSED PRODUCT AT ISSUE) OF LICENSED PRODUCT INVENTORY RENDERED OBSOLETE
BY THE CHANGE IN SPECIFICATIONS AND ANY NECESSARY REGULATORY APPROVAL COSTS.
(B)
ANY DISPUTES ARISING FROM A REQUEST FOR COST-SHARING OR
REIMBURSEMENT OF EXPENSES INCURRED IN CONNECTION WITH A CHANGE IN SPECIFICATIONS
NOT RESOLVED BY THE PARTIES WITHIN THIRTY (30) DAYS SHALL BE REFERRED TO THE
STEERING COMMITTEE FOR RESOLUTION; AND, IF NOT RESOLVED BY THE STEERING
COMMITTEE, THE PROVISIONS OF ARTICLE XVI OF THE LICENSE AGREEMENT SHALL APPLY TO
SUCH DISPUTE.
7.3.
RECORDS.
(A)
ANIKA SHALL KEEP COMPLETE, ACCURATE AND DETAILED ORIGINAL RECORDS
PERTAINING TO THE MANUFACTURE, INCLUDING QUALITY CONTROL, OF THE LICENSED
PRODUCT.
8
Confidential Treatment Requested
GALDERMA SHALL KEEP, AND WILL USE ITS REASONABLE EFFORTS TO THE EXTENT REQUIRED
BY LAW TO CAUSE OTHER GALDERMA SELLERS TO KEEP, COMPLETE, ACCURATE AND DETAILED
ORIGINAL RECORDS PERTAINING TO THE USE, STORAGE, SALE, DISTRIBUTION AND OTHER
DISPOSITION OF THE LICENSED PRODUCT, INCLUDING FOR EACH LOT NUMBER OF LICENSED
PRODUCT, THE QUANTITY SHIPPED AND WHERE THE LOT WAS SHIPPED, SO THAT, AMONG
OTHER THINGS, IN THE EVENT OF A RECALL, GALDERMA WILL BE ABLE TO CONTACT ALL
PHYSICIANS AND/OR END USERS OF LICENSED PRODUCTS.
EACH PARTY SHALL KEEP ITS
RESPECTIVE RECORDS FOR AT LEAST FIVE (5) YEARS OR FOR SUCH LONGER PERIOD IF AND
AS REQUIRED BY APPLICABLE LAW FROM THE DATE OF DELIVERY OR RECEIPT, AS
APPLICABLE, OF EACH BATCH OF LICENSED PRODUCT TO WHICH SAID RECORDS PERTAIN.
FOR VALIDATION BATCHES, EACH PARTY SHALL KEEP THE DOCUMENTS THROUGHOUT THE
COMMERCIAL LIFE OF THE RELEVANT LICENSED PRODUCTS.
(B)
EACH PARTY SHALL MAKE AVAILABLE SUCH RECORDS (INCLUDING MAKING
COPIES THEREOF) TO THE OTHER PARTY FOR SUCH LAWFUL PURPOSE AS SUCH OTHER PARTY
MAY REASONABLY