THE TRANSITION PERIOD GSK SHALL REPORT TO THE JSC THE
OVERALL STRATEGY AND TIMELINE OF ALL MATERIAL SUBMISSIONS AND FILINGS WITH ANY
REGULATORY AUTHORITY RELATING TO THE PRODUCT IN THE GSK TERRITORY.
(E)
EACH PARTY SHALL PROMPTLY NOTIFY THE OTHER PARTY IN WRITING OF ANY
MATERIAL CHANGES OR MATERIAL ISSUES THAT MAY ARISE IN CONNECTION WITH ANY IND,
MAA AND/OR ANY MARKETING APPROVALS IN ANY COUNTRY WITHIN THEIR RESPECTIVE
TERRITORIES.
(F)
SEPRACOR ACKNOWLEDGES THAT IN ORDER FOR MARKETING APPROVAL TO BE
OBTAINED IN MANY COUNTRIES WITHIN THE GSK TERRITORY BUT OUTSIDE OF THE EUROPEAN
UNION, IT WILL BE NECESSARY FOR GSK TO OBTAIN A CERTIFICATE OF PHARMACEUTICAL
PRODUCT FROM A SUITABLE REFERENCE COUNTRY, EITHER IN THE GSK TERRITORY OR IN THE
SEPRACOR TERRITORY. SEPRACOR AGREES TO PROVIDE GSK WILL ALL REASONABLE
ASSISTANCE IN OBTAINING SUCH CERTIFICATE OF PHARMACEUTICAL PRODUCT, AND WITHOUT
LIMITING THE FOREGOING, AGREES IN PARTICULAR TO:
CONFIDENTIAL
(I)
WORK WITH GSK TO ESTABLISH A SUPPLY ROUTE FOR THE PRODUCT WHICH
IS CAPABLE OF SUPPORTING THE ISSUE OF A CERTIFICATE OF PHARMACEUTICAL PRODUCT
FROM A SUITABLE REFERENCE COUNTRY;
(II)
GENERATE, IF NOT ALREADY AVAILABLE, AT GSK'S EXPENSE, 30/75
STABILITY DATA FOR THE PRODUCT USING THE SUPPLY ROUTE ESTABLISHED UNDER
SECTION 5.1(F)(I) ABOVE;
(III)
GENERATE SUFFICIENT NUMBER OF PRODUCT SAMPLES, AT GSK'S EXPENSE,
TO SUPPORT GSK'S ACTIVITIES IN SEEKING AND MAINTAINING MARKET APPROVAL IN THE
GSK TERRITORY.
(G)
SEPRACOR FURTHER ACKNOWLEDGES THAT UNTIL A SUPPLY
ROUTE HAS BEEN ESTABLISHED UNDER SECTION 5.1(F)(I), GSK WILL BE UNABLE TO
PROVIDE DETAILED REGULATORY OR COMMERCIALIZATION PLANS, WHERE REQUIRED UNDER
THIS AGREEMENT, IN RESPECT OF SUCH COUNTRIES WHERE A CERTIFICATE OF
PHARMACEUTICAL PRODUCT IS REQUIRED.
5.2.
REGULATORY PLAN. WITHIN NINETY (90) DAYS FOLLOWING THE
EXPIRY OR TERMINATION OF THE TRANSITION PERIOD, GSK SHALL PROVIDE FOR REVIEW BY
THE JSC AN OUTLINE PLAN SHOWING GSK'S PLANS FOR FILING MARKETING AUTHORIZATION
APPLICATIONS AND OBTAINING MARKET APPROVAL IN THE GSK TERRITORY. THE REGULATORY
PLAN SHALL INCLUDE A DESCRIPTION OF MATERIAL REGULATORY ACTIVITIES TO BE
UNDERTAKEN DURING THE FOLLOWING [**] YEARS, INCLUDING BUT NOT LIMITED TO,
PLANNED TASKS AND TIMELINES FOR THE CONDUCT OF THE REGULATORY ACTIVITIES WITH
RESPECT TO ALL MATTERS NECESSARY TO OBTAIN MARKETING APPROVAL FOR THE PRODUCT IN
EACH MAJOR MARKET OF THE GSK TERRITORY.
5.3.
REQUIRED STUDIES (NON-EMEA). IN THE EVENT THAT ANY
REGULATORY AUTHORITY IN THE GSK TERRITORY (OTHER THAN THE EMEA) REQUIRES OR
REQUESTS IN WRITING THAT REQUIRED STUDIES (OTHER THAN THOSE ALREADY INITIATED BY
SEPRACOR AS OF THE EFFECTIVE DATE) BE PERFORMED AS A CONDITION OF, OR IN
CONNECTION WITH, GRANTING MARKETING APPROVAL, [**] WHETHER OR NOT TO CONDUCT
SUCH REQUIRED STUDIES AND CONTINUE TO [**] IN SUCH COUNTRY. IF [**] SHALL
UNDERTAKE SUCH REQUIRED STUDIES [**]. IN THE EVENT THAT [**] DOES NOT [**], IN
RELATION TO COUNTRIES OTHER THAN THOSE WITHIN THE EUROPEAN UNION OR FOR WHICH A
DATE FOR ACCESSION TO THE EUROPEAN UNION HAS BEEN AGREED, SEPRACOR MAY, BUT
SHALL NOT BE OBLIGATED TO, TERMINATE THE AGREEMENT WITH RESPECT TO THE
PARTICULAR COUNTRY OR COUNTRIES WHERE