IN ACCORDANCE WITH ANY FEEDBACK
RECEIVED FROM EUROPEAN REGULATORY AUTHORITIES; PROVIDED, THAT IF THE CENTRALIZED
FILING PROCEDURE IS NOT USED, THEN ACCEPTANCE SHALL BE DETERMINED UPON THE
ACCEPTANCE OF SUCH DRUG APPROVAL APPLICATION BY THE APPLICABLE REGULATORY
AUTHORITY IN A MAJOR EUROPEAN COUNTRY, AND (C) IN JAPAN, RECEIPT BY GSK OF
WRITTEN NOTICE OF ACCEPTANCE OF FILING OF SUCH DRUG APPROVAL APPLICATION FROM
THE JAPANESE MINISTRY OF HEALTH, LABOUR AND WELFARE ("MHLW").
1.2
"ADVERSE EVENT" MEANS ANY UNFAVORABLE AND UNINTENDED CHANGE IN THE
STRUCTURE (SIGNS), FUNCTION (SYMPTOMS), OR CHEMISTRY (LABORATORY DATA), OF THE
BODY TEMPORALLY ASSOCIATED WITH THE USE OF A PRODUCT, WHETHER OR NOT CONSIDERED
RELATED TO THE USE OF THE PRODUCT.
CHANGES RESULTING FROM NORMAL GROWTH AND
DEVELOPMENT WHICH DO NOT VARY SIGNIFICANTLY IN FREQUENCY OR SEVERITY FROM
EXPECTED LEVELS ARE NOT TO BE CONSIDERED ADVERSE EXPERIENCES.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
1.3
"AFFILIATE" MEANS, WITH RESPECT TO ANY PERSON, ANY OTHER PERSON
THAT, DIRECTLY OR INDIRECTLY, CONTROLS, OR IS CONTROLLED BY, OR IS UNDER COMMON
CONTROL WITH, SUCH PERSON.
FOR PURPOSES OF THIS DEFINITION, "CONTROL" MEANS
(A) THE DIRECT OR INDIRECT OWNERSHIP OF MORE THAN FIFTY PERCENT (50%) OF THE
SHARES OF STOCK ENTITLED TO VOTE FOR THE ELECTION OF DIRECTORS IN THE CASE OF A
CORPORATION, OR MORE THAN FIFTY PERCENT (50%) OF THE EQUITY INTERESTS IN THE
CASE OF ANY OTHER TYPE OF LEGAL ENTITY, OR WITH RESPECT TO EITHER OF THE
FOREGOING, SUCH LESSER MAXIMUM PERCENTAGE PERMITTED IN THOSE JURISDICTIONS WHERE
MAJORITY OWNERSHIP BY FOREIGN ENTITIES IS PROHIBITED, (B) STATUS AS A GENERAL
PARTNER IN ANY PARTNERSHIP, OR (C) ANY OTHER ARRANGEMENT WHEREBY A PERSON
CONTROLS OR HAS THE RIGHT TO CONTROL THE BOARD OF DIRECTORS OF A CORPORATION OR
EQUIVALENT GOVERNING BODY OF AN ENTITY OTHER THAN A CORPORATION.
1.4
"AGGREGATE EQUITY PURCHASE PRICE" MEANS (A) WITH RESPECT TO THE
INITIAL EQUITY PURCHASE OBLIGATION SET FORTH IN SECTION 6.2.1, TWENTY FIVE
MILLION DOLLARS (US $25,000,000) AND (B) WITH RESPECT TO THE SUBSEQUENT EQUITY
PURCHASE RIGHT SET FORTH IN SECTION 6.2.2, TWENTY MILLION DOLLARS (US
$20,000,000).
1.5
"ANNUAL NET SALES" MEANS, WITH RESPECT TO ANY CALENDAR YEAR, THE
AGGREGATE AMOUNT OF THE NET SALES FOR SUCH CALENDAR YEAR.
1.6
"API" MEANS THE ACTIVE PHARMACEUTICAL INGREDIENT KNOWN AS STA-4783
AND/OR ANY OTHER COLLABORATION COMPOUND DEVELOPED AND COMMERCIALIZED UNDER THIS
AGREEMENT.
1.7
"APPLICABLE LAWS" MEANS ANY NATIONAL, SUPRA-NATIONAL, FEDERAL,
STATE OR LOCAL LAWS, TREATIES, STATUTES, ORDINANCES, RULES AND REGULATIONS,
INCLUDING ANY RULES, REGULATIONS, GUIDANCE OR GUIDELINES HAVING THE BINDING
EFFECT OF LAW, OR REQUIREMENTS OF REGULATORY AUTHORITIES, NATIONAL SECURITIES
EXCHANGES OR SECURITIES LISTING ORGANIZATIONS, GOVERNMENT AUTHORITIES, COURTS,
TRIBUNALS, AGENCIES OTHER THAN REGULATORY AUTHORITIES, LEGISLATIVE BODIES AND
COMMISSIONS THAT ARE IN EFFECT FROM TIME TO TIME DURING THE TERM AND APPLICABLE
TO A PARTICULAR ACTIVITY HEREUNDER.
1.8
"APPLICABLE PREMIUM" MEANS A PREMIUM EQUAL TO [***] PERCENT