QAS FOR THE U.S. AND IN
THE TERRITORY OUTSIDE THE U.S.
THE TABLE OF CONTENTS OF A SAMPLE QA IS ATTACHED
FOR REFERENCE ONLY AS EXHIBIT C.
1.23
"QUALITY AUDIT" HAS THE MEANING PROVIDED IN
SECTION 4.6(B) OF THIS AGREEMENT.
1.24
"REGULATORY AUTHORITY" MEANS, IN A PARTICULAR
COUNTRY OR JURISDICTION, ANY APPLICABLE GOVERNMENT REGULATORY AUTHORITY INVOLVED
IN GRANTING MARKETING APPROVAL AND/OR, TO THE EXTENT REQUIRED IN SUCH COUNTRY OR
JURISDICTION, INCLUDING WITHOUT LIMITATION, THE FDA AND ANY OTHER APPLICABLE
GOVERNMENTAL OR REGULATORY AUTHORITY IN THE U.S. HAVING JURISDICTION OVER THE
DEVICES, AND ANY SUCCESSOR GOVERNMENT AUTHORITY HAVING SUBSTANTIALLY THE SAME
FUNCTION, AND ANY FOREIGN EQUIVALENT THEREOF.
1.25
"SHARED CAPACITY" MEANS CAPACITY THAT IS DESIGNATED
TO BE USED IN PART FOR THE DEVICES, INCLUDING COMPONENTS OR PARTS THEREOF, AND
IN PART FOR OTHER PURPOSES.
1.26
"SPECIFICATIONS" MEANS THE SPECIFICATIONS AND
QUALITY CONTROL TESTING PROCEDURES FOR DEVICE DEVELOPMENT, MANUFACTURING, FINAL
RELEASE AND TESTING OF A DEVICE AND LABELING AND PACKAGING REQUIREMENTS, WHICH
MAY COVER ONE OR MORE VERSIONS OF THE DEVICE INCLUDING, WITHOUT LIMITATION,
DEVICES HAVING DIFFERENT PHYSICAL FEATURES AND LABELING AS SET FORTH IN
APPLICABLE MARKETING APPROVALS, AS THE SAME MAY BE MODIFIED FROM TIME TO TIME BY
THE PARTIES IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT.
THE SPECIFICATIONS
WILL BE AN EXHIBIT TO THE QUALITY AGREEMENT.
1.27
"SUCCESSOR MANUFACTURER" SHALL HAVE THE MEANING SET
FORTH IN SECTION 11.5.4 OF THIS AGREEMENT.
5
1.28
"THIRD PARTY SUPPLIER" SHALL HAVE THE MEANING SET
FORTH IN SECTION 4.7 OF THIS AGREEMENT.
ARTICLE 2
GOVERNANCE
2.1
GOVERNANCE OF ACTIVITIES.
GOVERNANCE OF THE
ACTIVITIES CONTEMPLATED BY THIS AGREEMENT WILL BE EFFECTED THROUGH THE
GOVERNANCE STRUCTURE ESTABLISHED IN THE COLLABORATION AGREEMENT FOR MANUFACTURE
OF PRODUCT, EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT.
2.2
DEVICE WORKING TEAM.
THE PARTIES WILL
ESTABLISH THE DEVICE WORKING TEAM ("DEVICE WORKING TEAM" OR "DWT") WHICH WILL BE
RESPONSIBLE FOR DEVELOPMENT ACTIVITIES WITH RESPECT TO THE DEVICE, INCLUDING
DEVELOPMENT OF THE SPECIFICATIONS, AND ANY SUBSEQUENT MODIFICATIONS THERETO, AND
DEVELOPMENT OF ASSEMBLY AND PACKAGING REQUIREMENTS AND CAPACITY AND ONGOING
TECHNICAL SUPPORT FOR DEVICE MANUFACTURING OPERATIONS.
ALL SPECIFICATIONS SHALL
BE APPROVED BY THE COMMITTEE.
EACH PARTY SHALL BE RESPONSIBLE FOR OBTAINING ALL
NECESSARY APPROVALS OF THE SPECIFICATIONS FROM SUCH PARTY'S INTERNAL COMMITTEES
PRIOR TO THE TIME THAT THE SPECIFICATIONS ARE SUBMITTED TO THE COMMITTEE.
THE DWT SHALL DEVELOP A DEVICE DEVELOPMENT PLAN (THE "DEVICE
DEVELOPMENT PLAN") THAT WILL SET FORTH IN DETAIL THE DEVICE DEVELOPMENT
ACTIVITIES TO BE UNDERTAKEN, THE ROLES AND RESPONSIBILITIES OF THE PARTIES WITH
RESPECT THERETO, AND THE TIMELINE FOR DEVICE DEVELOPMENT ACTIVITIES.
THE DWT
WILL ALSO PREPARE A DEVICE DEVELOPMENT BUDGET WHICH WILL BE INCLUDED WITHIN THE
DEVICE DEVELOPMENT PLAN.
THE COMMITTEE SHALL APPROVE THE DEVICE DEVELOPMENT
PLAN.
(A)
MEMBERSHIP.
THE DWT SHALL BE COMPRISED OF NO MORE THAN THREE (3)
REPRESENTATIVES OF EACH PARTY.
THE COMMITTEE SHALL HAVE PRINCIPAL
RESPONSIBILITY FOR OVERSEEING THE ACTIVITIES OF THE DWT.
EACH PARTY MAY CHANGE
ITS DWT MEMBERS AT ANY TIME BY WRITTEN NOTICE TO THE OTHER.
SUCH NOTICE MAY