REQUEST.
FOLLOWING VALIDATION OF A PROCESS AND OR PROCESS CHANGE, COMPANY SHALL
PROMPTLY NOTIFY DISTRIBUTOR OF SUCH VALIDATION AND, UPON REQUEST, DELIVER A COPY
OF THE VALIDATION REPORT TO THE DISTRIBUTOR AND THE ASSOCIATED STABILITY DATA,
IF APPLICABLE.
6.4.
COMPLIANCE WITH PRODUCT SPECIFICATIONS.
COMPANY SHALL BE
RESPONSIBLE FOR ASSURING THAT ALL PRODUCT MANUFACTURED, SHIPPED AND DELIVERED BY
COMPANY TO DISTRIBUTOR UNDER THIS AGREEMENT CONFORMS TO THE RELEVANT
SPECIFICATIONS FOR THE PRODUCT, SHALL BE PACKAGED AND LABELLED IN ACCORDANCE
WITH THIS AGREEMENT AND THE THEN-CURRENT PACKAGING AND LABELLING SPECIFICATIONS
AND IS IN COMPLIANCE IN ALL MATERIAL RESPECTS WITH ALL REQUIREMENTS OF
APPLICABLE LAWS, RULES AND REGULATIONS, ALL OTHER REQUIREMENTS OF ANY APPLICABLE
CGMP OR THE PRODUCT REGISTRATION.
DISTRIBUTOR SHALL SUPPLY COMPANY WITH
DISTRIBUTOR'S LABELLING STANDARDS FOR THE PRODUCT (INCLUDING THE NDC
NUMBER(S) AND BAR CODES) BEARING DISTRIBUTOR'S CORPORATE NAME AND TRADE DRESS.
COMPANY SHALL PRINT LABELS, TUBES AND OTHER PRINTED MATERIAL TO BE INCLUDED AS
PART OF THE PRODUCT AND THE COST OF DOING SO SHALL BE REFLECTED IN THE PRICE
CHARGED BY COMPANY FOR THE PRODUCT PURSUANT TO SECTION 3.2.
PRODUCT PACKAGING
SHALL INCLUDE, TO THE EXTENT PERMITTED BY APPLICABLE LAWS, A SMALL GRAPIC/TEXT
MARK FOR "CERAGENIX PHARMACEUTICALS" WHICH SHALL BE REASONABLY ACCEPTABLE TO
COMPANY.
6.5.
MANUFACTURING FACILITY GMP COMPLIANCE.
COMPANY SHALL (AND SHALL
CAUSE ANY CONTRACT MANUFACTURER TO) MAINTAIN ALL EQUIPMENT AND MANUFACTURING
FACILITIES USED TO MANUFACTURE PRODUCT IN GOOD WORKING CONDITION AND IN
COMPLIANCE WITH CGMP.
6.6.
PRODUCT RELEASE TESTING.
COMPANY SHALL OBTAIN REPRESENTATIVE
SAMPLES FROM EACH BATCH OF PRODUCT PRODUCED AND SHALL ASSAY AND ANALYZE SUCH
SAMPLES IN STRICT ACCORDANCE WITH THE RELEVANT SPECIFICATIONS AND STANDARD
OPERATING PROCEDURES FOR THE PRODUCT.
COMPANY SHALL NOT SHIP ANY PRODUCT
HEREUNDER WHICH, AS INDICATED BY A SAMPLE ASSAY OR ANALYSIS, AS SET FORTH ABOVE,
DOES NOT CONFORM TO THE RELEVANT SPECIFICATIONS FOR THE PRODUCT.
ANY PRODUCT OR
THE MANUFACTURE THEREOF THAT DOES NOT CONFORM TO THE RELEVANT SPECIFICATIONS FOR
THE PRODUCT SHALL BE DISPOSED OF BY COMPANY, AT COMPANY'S COST, IN ACCORDANCE
WITH APPLICABLE LAWS.
6.7.
STABILITY TESTING.
COMPANY SHALL, AT ITS OWN COST, PROVIDE ALL
ONGOING STABILITY SUPPORT RELATING TO THE PRODUCT IN ACCORDANCE WITH FDA
REQUIREMENTS, INCLUDING, WITHOUT LIMITATION, PREPARATION AND KEEPING OF
DOCUMENTATION, RECORDS AND REPORTS RELATING THERETO.
(A)
IF COMPANY AND DISTRIBUTOR DISAGREE AS TO WHETHER ANY SAMPLE OF
PRODUCT MEETS THE RELEVANT SPECIFICATIONS FOR THE PRODUCT, THE MATTER WILL BE
SUBMITTED TO AN INDEPENDENT TESTING LABORATORY, ACCEPTABLE TO BOTH PARTIES, FOR
ANALYSIS, WHICH ANALYSIS SHALL BE PERFORMED IN COMPLIANCE WITH APPLICABLE LAWS
AND THE SPECIFICATIONS AND METHODOLOGIES SET FORTH IN OR IDENTIFIED BY THE
REGISTRATION FOR THE PRODUCT, TO DETERMINE WHETHER THE PRODUCT CONFORMED OR DID
NOT CONFORM TO THE SPECIFICATIONS AND THE TEST RESULTS OBTAINED FROM SUCH
LABORATORY SHALL BE FINAL AND BINDING UPON BOTH PARTIES.
THE FEES AND EXPENSES
OF SUCH TESTING SHALL BE BORNE BY THE PARTY ULTIMATELY DETERMINED TO HAVE
INCORRECTLY JUDGED WHETHER THE PRODUCT MET THE RELEVANT SPECIFICATIONS.
17
(B)
DISTRIBUTOR MAY RETURN ANY PRODUCT TO COMPANY FOR FULL