PRODUCT OR
FINISHED PRODUCT AFTER SHIPMENT, THEN THE COSTS AND EXPENSES OF SUCH RECALL OR
SEIZURE, INCLUDING THE COST OF REPLACEMENT FINISHED PRODUCTS, SHALL BE PAID BY
CEPHALON.
IF THE PRODUCT OR FINISHED PRODUCT DEFECT CAUSING THE RECALL OR
SEIZURE DOES NOT RESULT PRIMARILY FROM THE ACTS OR OMISSIONS OF EITHER PARTY OR
SUCH CAUSE CANNOT BE DETERMINED WITH REASONABLE CERTAINTY, THEN THE COSTS AND
EXPENSES OF SUCH RECALL OR SEIZURE, INCLUDING THE COST OF REPLACEMENT FINISHED
PRODUCTS, SHALL BE SHARED EXPENSES.
RECALLS OR SEIZURES SHALL OTHERWISE BE
CONDUCTED IN ACCORDANCE WITH THE PROVISIONS OF THE QUALITY AGREEMENT.
3.14
PRODUCT COMPLAINTS AND ADVERSE EVENT REPORTING.
THE PROCEDURES FOR
HANDLING PRODUCT COMPLAINTS AND REPORTING ADVERSE EVENTS SHALL BE SET FORTH IN
THE QUALITY AGREEMENT AND THE SAFETY DATA EXCHANGE AGREEMENT EXECUTED PURSUANT
TO THE LICENSE AND COLLABORATION AGREEMENT.
3.15
COMMERCIALLY REASONABLE MANUFACTURING EFFORTS.
ALKERMES SHALL USE
COMMERCIALLY REASONABLE MANUFACTURING EFFORTS TO MANUFACTURE AND SUPPLY PRODUCT
IN A TIMELY AND COST-EFFECTIVE MANNER AND IN SUFFICIENT QUANTITIES TO ENABLE THE
PARTIES TO CARRY OUT THE DEVELOPMENT PLANS AND THE COMMERCIALIZATION PLANS, IN
EACH CASE TO THE EXTENT THAT SUCH PLANS REFLECT GOOD FAITH PROJECTIONS OF THE
DEMAND FOR THE PRODUCT CONSISTENT WITH THE LONG-RANGE COMMERCIALIZATION PLAN.
3.16
REPRESENTATIONS AND WARRANTIES OF ALKERMES.
ALKERMES HEREBY
REPRESENTS AND WARRANTS THAT:
(a)
Alkermes shall perform its obligations under this Agreement in a
competent, professional and workmanlike manner;
(b)
all Product and Finished Product shall have been Manufactured in
accordance with the Procedures, cGMPs, the Quality Agreement, and shall, as of
the date delivered to the common carrier, meet the Specifications; and
(c)
no Product or Finished Product shall, as of the date delivered to
the common carrier, be adulterated or misbranded, within the meanings ascribed
to such terms under the Act.
In addition, (i) the representation and warranty of Alkermes made in
Section 10.3(v) of the License and Collaboration Agreement to the extent
applicable to the manufacture of the Product is incorporated herein by
reference, and (ii) the provisions of Section 7.7 of the License and
Collaboration Agreement shall apply in the event that either Party
*
CONFIDENTIAL TREATMENT REQUESTED
14
believes that it is necessary or desirable to obtain a patent license from a
Third Party [**].
3.17
NO IMPLIED REPRESENTATIONS, WARRANTIES OR CONDITIONS.
EXCEPT AS
OTHERWISE EXPRESSLY HEREIN PROVIDED, ALKERMES MAKES NO REPRESENTATIONS OR
WARRANTIES AND THERE ARE NO CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE, WITH RESPECT TO THE PRODUCTS SUPPLIED HEREUNDER, INCLUDING ANY SUCH
REPRESENTATIONS, WARRANTIES OR CONDITIONS WITH RESPECT TO THE NON-INFRINGEMENT
OF THIRD PARTY RIGHTS, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF
SUCH PRODUCT.
ARTICLE 4
PAYMENTS
4.1
PAYMENT FOR PRODUCT REQUIREMENTS AND PLACEBO REQUIREMENTS.
FOR
EACH DOSAGE UNIT OF PRODUCT AND EACH UNIT OF PLACEBO PRODUCED BY ALKERMES
PURSUANT TO A FIRM ORDER AND SHIPPED TO CEPHALON HEREUNDER, CEPHALON SHALL PAY
ALKERMES THE FULLY BURDENED MANUFACTURING COST OF SUCH DOSAGE UNIT OF PRODUCT OR
UNIT OF PLACEBO.
4.2
INVOICES AND METHOD OF PAYMENT OF AMOUNTS DUE