THE PRODUCT AND SHALL
NOT IMPLEMENT ANY SUCH CHANGES WITHOUT DISTRIBUTOR'S PRIOR WRITTEN APPROVAL,
WHICH APPROVAL MAY BE WITHHELD IN DISTRIBUTOR'S SOLE AND ABSOLUTE DISCRETION IF
ANY SUCH CHANGE WOULD RESULT IN A MATERIAL CHANGE TO THE REGISTRATION OR PRODUCT
PERFORMANCE AND/OR CHARACTERISTICS, AS DEFINED IN THE SPECIFICATIONS FOR THE
PRODUCT. THE COMPANY SHALL ALSO INFORM THE DISTRIBUTOR IN ADVANCE OF ANY PLANNED
CHANGES IN PROCESSES, FACILITIES OR EQUIPMENT THAT MAY IMPACT THE PRODUCT AND
SHALL NOT IMPLEMENT FORMULATION CHANGES WITHOUT DISTRIBUTOR'S PRIOR WRITTEN
APPROVAL (WHICH APPROVAL MAY BE WITHHELD IN DISTRIBUTOR'S REASONABLE
DISCRETION).
(B)
THE DISTRIBUTOR SHALL FROM TIME TO TIME HAVE THE RIGHT TO
PROPOSE CHANGES TO THE PRODUCTS.
IF DISTRIBUTOR AT ANY TIME REQUESTS A CHANGE
TO THE PRODUCT AND COMPANY AGREES SUCH CHANGE IS FEASIBLE WITH REGARD TO THE
PRODUCT'S MANUFACTURING PROCESS, SUCH CHANGE SHALL BE INCORPORATED WITHIN THE
MASTER BATCH RECORD AND/OR SPECIFICATIONS FOR THE PRODUCT IN THE FORM OF A
WRITTEN REQUEST REVIEWED AND AGREED UPON BY BOTH COMPANY
AND DISTRIBUTOR.
(C)
IN THE EVENT A CHANGE TO THE PRODUCT IS REQUIRED BY A REGULATORY
AUTHORITY WITH JURISDICTION OF THE PRODUCT, THE DISTRIBUTOR AND COMPANY AGREE
THAT ANY CHANGES REQUIRED BY SUCH REGULATORY AUTHORITY, SHALL BE INCORPORATED
INTO THE PRODUCT SPECIFICATIONS AS EVIDENCED BY THE WRITTEN APPROVAL OF
DISTRIBUTOR PRIOR TO SUCH INCORPORATION.
AT THE TIME OF SUCH INCORPORATION,
SUCH CHANGES SHALL BECOME PART OF THE SPECIFICATIONS.
6.11.
Registrations.
Company shall, at its sole cost and expense (which
shall not be included in the Cost):
(A)
BE RESPONSIBLE FOR MAINTAINING THE 510(K) TECHNICAL DOSSIER FOR
THE PRODUCT AND FOR FILING, REGISTRATION AND MAINTENANCE OF ALL OTHER REGULATORY
AUTHORIZATIONS IN THE TERRITORY IN RESPECT OF ITS ACTIVITIES RELATING TO THE
PRODUCT;
(B)
BE RESPONSIBLE FOR DETERMINING WHETHER OR NOT TO INITIATE
REGISTRATION VARIATION PROCEDURES AND FOR MAINTAINING ADEQUATE CONTROL OVER THE
QUALITY COMMITMENTS FOR THE MARKETING AUTHORIZATION MADE TO THE REGULATORY
AUTHORITIES FOR PRODUCT; AND
(C)
BE RESPONSIBLE FOR THE TEXT AND REGULATORY COMPLIANCE OF ALL
IMMEDIATE AND SECONDARY PRODUCT LABELING (INCLUDING PACKAGE INSERTS) AND SHALL
PROVIDE DISTRIBUTOR COPIES OF ALL REGULATORY APPROVALS RELATED TO THE PRODUCT.
FOR PURPOSES OF CLARITY, IMMEDIATE AND SECONDARY PRODUCT LABELING SHALL NOT
INCLUDE ANY PROMOTIONAL LABELING FOR THE PRODUCT DEVELOPED BY DISTRIBUTOR.
6.12.
Quality System and Design Control Requirements.
The Parties agree to
enter into a Quality System and Design Control Agreement at least sixty days
(60) before the Launch Date of the Product which sets forth (a) the roles and
responsibilities of Company and Distributor with respect to quality system
regulations for the Product as required under Applicable Laws, and (b) how the
Parties' shall interact with each other in connection with same ("Quality System
and Design Control Agreement").
The Parties have agreed to basic terms
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FOR THE QUALITY SYSTEM AND DESIGN CONTROL AGREEMENT WHICH SHALL INCLUDE, BUT NOT
BE LIMITED TO, THE OUTLINE PROVIDED IN SCHEDULE 6.12.
IN THE EVENT A CONFLICT
ARISES BETWEEN ANY TERM IN THIS AGREEMENT AND A TERM IN THE QUALITY