WITH LAW
20.1.
EXPORT LAWS. NOTWITHSTANDING ANYTHING TO THE CONTRARY
CONTAINED HEREIN, ALL OBLIGATIONS OF SEPRACOR AND GSK ARE SUBJECT TO PRIOR
COMPLIANCE WITH EXPORT AND IMPORT REGULATIONS AND SUCH OTHER LAWS AND
REGULATIONS IN EFFECT IN SUCH JURISDICTIONS OR ANY OTHER RELEVANT COUNTRY AS MAY
BE APPLICABLE, AND TO OBTAINING ALL NECESSARY APPROVALS REQUIRED BY THE
APPLICABLE AGENCIES OF THE GOVERNMENTS OF ANY RELEVANT COUNTRIES. SEPRACOR AND
GSK SHALL COOPERATE WITH EACH OTHER AND SHALL PROVIDE ASSISTANCE TO THE OTHER AS
REASONABLY NECESSARY TO OBTAIN ANY REQUIRED APPROVALS.
20.2.
SECURITIES LAWS. EACH OF THE PARTIES ACKNOWLEDGES THAT IT IS
AWARE THAT THE SECURITIES LAWS OF THE UNITED STATES AND THE SECURITIES LAWS OF
OTHER COUNTRIES PROHIBIT ANY PERSON WHO HAS MATERIAL NON-PUBLIC INFORMATION
ABOUT A PUBLICLY LISTED COMPANY FROM PURCHASING OR SELLING SECURITIES OF SUCH
COMPANY OR FROM COMMUNICATING SUCH INFORMATION TO ANY PERSON UNDER CIRCUMSTANCES
IN WHICH IT IS REASONABLY FORESEEABLE THAT SUCH PERSON IS LIKELY TO PURCHASE OR
SELL SUCH SECURITIES. EACH PARTY AGREES TO COMPLY WITH SUCH SECURITIES LAWS MAKE
ITS AFFILIATES,
CONFIDENTIAL
SUBLICENSEES, EMPLOYEES AND AGENTS AWARE OF THE EXISTENCE OF SUCH SECURITIES
LAWS AND THEIR NEED TO COMPLY WITH SUCH LAWS.
20.3.
CERTAIN PAYMENTS. EACH OF THE PARTIES ACKNOWLEDGES THAT IT
IS AWARE THAT THE UNITED STATES AND OTHER COUNTRIES HAVE STRINGENT LAWS WHICH
PROHIBIT PERSONS DIRECTLY OR INDIRECTLY TO MAKE UNLAWFUL PAYMENTS TO, AND FOR
THE BENEFIT OF, GOVERNMENT OFFICIALS AND RELATED PARTIES TO SECURE APPROVALS OR
PERMISSION FOR THEIR ACTIVITIES. EACH PARTY AGREES THAT IT WILL MAKE NO SUCH
PROHIBITED PAYMENTS, IT WILL NOT INDIRECTLY MAKE OR HAVE MADE SUCH PAYMENTS AND
IT WILL MAKE ITS AFFILIATES, EMPLOYEES AND AGENTS AWARE OF THE EXISTENCE OF SUCH
LAWS AND THEIR NEED TO COMPLY WITH SUCH LAWS.
20.4.
CONDUCT OF ACTIVITIES. AS TO ALL MATTERS CONTAINED IN THIS
AGREEMENT, EACH PARTY SHALL CONDUCT THE ACTIVITIES ALLOCATED TO IT IN COMPLIANCE
IN ALL MATERIAL RESPECTS WITH ALL APPLICABLE LAWS, RULES AND REGULATIONS AND IN
ACCORDANCE WITH GOOD SCIENTIFIC, CLINICAL AND MANUFACTURING PRACTICES,
APPLICABLE UNDER THE LAWS AND REGULATIONS OF THE COUNTRY IN WHICH SUCH
ACTIVITIES ARE CONDUCTED.
CONFIDENTIAL
IN WITNESS WHEREOF, Sepracor Inc. and Glaxo Group Limited, have executed this
Development, License and Commercialization Agreement as of the Effective Date.
Sepracor Inc.
BY:
/s/ Adrian Adams
Date:
9/10/07
NAME: Mr. Adrian Adams
TITLE: President & CEO
Glaxo Group Limited
BY:
/s/ Paul Williamson
Date:
NAME: Paul Williamson on behalf of
Edinburgh Pharmaceutical Industries Limited
TITLE: Corporate Director
CONFIDENTIAL
Schedules and Exhibits
Schedules
Schedule 1.39
Trademarks
Part A:
Product Trademarks
Part B:
Other Trademarks
Schedule 1.44
Sepracor Patents
Schedule 1.50
FDA-approved label
Schedule 7.3(c)
Hypothetical Royalty Calculation
Schedule 7.3(e)
Hypothetical Calculation of Cost of Bulk Tablets and Net Sales
Schedule 10.2
Heads of Terms for Supply Agreement
Schedule 16.2(g)
Threatened and Pending Litigation in GSK Territory
CONFIDENTIAL
SCHEDULE 1.39
TRADEMARKS
Part A: Product Trademarks
Jurisdiction
Trademark
Status
App. No.
Filing Date
Reg. No.
Reg. Date
Brazil
LUNIVIA
Published
825757444
11-Aug-2003
Chile
LUNIVIA