COSMETIC ACT AS
AMENDED FROM TIME-TO-TIME.
1.2
"ADVERSE DRUG EVENT" SHALL MEAN ANY EXPERIENCE WITH ANY OF THE
PRODUCT, WHICH MAY IMPACT THE PRODUCT APPROVAL AND WHICH SHALL INCLUDE ANY
UNFAVORABLE, UNUSUAL OR UNWANTED SIGNS, SYMPTOMS, OR LABORATORY VALUES (WHETHER
OR NOT CONSIDERED DRUG RELATED) EXPERIENCED BY A PATIENT OR CUSTOMER THAT MAY BE
ATTRIBUTABLE TO THE API.
1.3
"AFFILIATE" SHALL MEAN IN RESPECT OF A PARTY HERETO, ANY
CORPORATION OR BUSINESS ENTITY CONTROLLED BY, CONTROLLING, OR UNDER COMMON
CONTROL WITH A PARTY.
(FOR THE PURPOSE OF THIS DEFINITION, "CONTROL" MEANS
DIRECT OR INDIRECT BENEFICIAL OWNERSHIP OF GREATER THAN FIFTY PERCENT (50%) OF
THE VOTING STOCK OF SUCH CORPORATION OR OTHER BUSINESS ENTITY, OR A GREATER THAN
FIFTY PERCENT (50%) INTEREST IN THE INCOME OF SUCH CORPORATION OR OTHER BUSINESS
ENTITY, OR THE POWER TO DIRECT OR CAUSE THE DIRECTION OF THE MANAGEMENT AND
POLICIES OF SUCH CORPORATION OR OTHER BUSINESS ENTITY WHETHER BY OWNERSHIP OF
VOTING SECURITIES, BY CONTRACT OR OTHERWISE, OR SUCH OTHER RELATIONSHIP THAT, IN
FACT, CONSTITUTES CONTROL.)
1.4
"AGREEMENT" SHALL MEAN THIS SUPPLY AGREEMENT, AS AMENDED FROM TIME
TO TIME.
1.5
"API" SHALL MEAN TIACUMICIN [***] ACTIVE PHARMACEUTICAL INGREDIENT
(CAS REGISTRY NUMBER CAS [***]) AS FURTHER DEFINED BY THE API SPECIFICATIONS.
1.6
"API SPECIFICATIONS" SHALL MEAN THE SPECIFICATIONS FOR THE API
CONTAINED IN THE NDA OR DMF ESTABLISHED BY PAR PURSUANT TO THIS AGREEMENT,
UNLESS CHANGES ARE REQUIRED IN THE UNITED STATES PHARMACOPEIA, AS SUCH
SPECIFICATIONS MAY BE AMENDED AT THE REQUEST OF THE FDA OR BY MUTUAL AGREEMENT
OF THE PARTIES FROM TIME TO TIME.
UNTIL SUCH TIME AS A NDA OR DMF IS SUBMITTED
TO THE FDA, THE TERM API SPECIFICATIONS SHALL HAVE THE MEANING AS SET FORTH IN
EXHIBIT A.
1.7
"APPLICABLE LAWS" MEANS ALL APPLICABLE LAWS, RULES, AND
REGULATIONS THAT APPLY TO THE MANUFACTURE, DEVELOPMENT, MARKETING, SALE OR
COMMERCIALIZATION OF PRODUCT OR THE PERFORMANCE OF EITHER PARTY'S OBLIGATIONS
UNDER THIS AGREEMENT INCLUDING LAWS AND REGULATIONS GOVERNING THE IMPORT,
EXPORT, DEVELOPMENT, MARKETING, DISTRIBUTION AND SALE OF PRODUCT, TO THE EXTENT
APPLICABLE AND RELEVANT, AND INCLUDING ALL CGMP (DEFINED BELOW) OR CURRENT GOOD
CLINICAL PRACTICES OR SIMILAR STANDARDS OR GUIDELINES PROMULGATED OR ADOPTED BY
THE FDA WHERE APPLICABLE, AS WELL AS U.S. EXPORT CONTROL LAWS AND THE U.S.
FOREIGN CORRUPT PRACTICES ACT.
1.8
"CGMP" SHALL MEAN CURRENT GOOD MANUFACTURING PRACTICES AS REQUIRED
BY THE RULES AND REGULATIONS OF FDA.
1.9
"COMMERCIALLY REASONABLE EFFORTS" MEANS WITH RESPECT TO EACH
PARTY, EFFORTS
AND COMMITMENT OF RESOURCES IN ACCORDANCE WITH SUCH PARTY'S
REASONABLE BUSINESS, LEGAL, MEDICAL, AND SCIENTIFIC JUDGMENT THAT ARE CONSISTENT
WITH THE EFFORTS AND RESOURCES SUCH PARTY WOULD USE FOR ITS OTHER PRODUCTS OR
PROJECTS, WHICH ARE OF SIMILAR MARKET POTENTIAL AND AT A SIMILAR STAGE IN THEIR
LIFE CYCLE, TAKING INTO ACCOUNT THE COMPETITIVENESS OF THE MARKET PLACE, THE
REGULATORY STRUCTURE INVOLVED AND OTHER RELEVANT FACTORS THAT ARE NOT SUBJECT TO
EACH PARTY'S CONSENTS.
1.10
"COMMERCIAL LAUNCH" SHALL MEAN THE DATE OF THE FIRST COMMERCIAL
SALE OF A PRODUCT CONTAINING THE API BY