OR HEREAFTER KNOWN AND AVAILABLE TO
UNIVERSITY, LICENSOR OR ITS AFFILIATES, WHETHER GENERALLY KNOWN TO OTHERS OR
NOT, WHICH CONCERNS PRODUCT AND DOES NOT CONCERN PHARMANOVA PRODUCT.
2.7
"COLLABORATION COMMITTEE" MEANS THE
COMMITTEE DESCRIBED IN SECTION 6.
2
2.8
"COMMERCIALIZE" OR "COMMERCIALIZATION" MEANS
THE ONGOING PROCESS AND ACTIVITIES GENERALLY ENGAGED IN BY A PHARMACEUTICAL
COMPANY TO SELL AND MARKET A PHARMACEUTICAL PRODUCT.
2.9
"CONFIDENTIAL INFORMATION" MEANS INFORMATION
THAT IS MARKED AS CONFIDENTIAL, OR, IF ORALLY DISCLOSED, IS INDICATED AT THE
TIME OF DISCLOSURE AS CONFIDENTIAL AND PROVIDED IN WRITTEN FORM WITHIN THIRTY
DAYS.
NOT WITHSTANDING THE FOREGOING, THE RECEIVING PARTY WILL HAVE NO
OBLIGATION OF CONFIDENTIALITY RELATING TO ANY INFORMATION OF THE DISCLOSING
PARTY THAT:
(I)
IS OR BECOMES PART OF THE PUBLIC DOMAIN
THROUGH NO FAULT OF THE RECEIVING PARTY;
(II)
IS KNOWN TO THE RECEIVING PARTY PRIOR TO
THE DISCLOSURE BY THE DISCLOSING PARTY, AS EVIDENCED BY DOCUMENTATION;
(III)
IS INDEPENDENTLY DEVELOPED BY THE RECEIVING
PARTY WITHOUT REFERENCE OR USE OF THE CONFIDENTIAL INFORMATION OR WITHOUT ANY
BREACH OF THIS AGREEMENT AS EVIDENCED BY DOCUMENTATION;
(IV)
IS SUBSEQUENTLY OBTAINED BY THE RECEIVING
PARTY FROM A DULY AUTHORIZED THIRD PARTY;
(V)
IS PUBLICLY RELEASED AS AUTHORIZED UNDER
THIS AGREEMENT BY THE DISCLOSING PARTY, ITS EMPLOYEES OR AGENTS.
2.10
"CONFIDENTIALITY AGREEMENT" MEANS THAT CERTAIN
CONFIDENTIALITY AGREEMENT BETWEEN LICENSOR AND LICENSEE DATED MAY 24, 2004.
2.11
"CONTROL" OR "CONTROLLED" SHALL MEAN, WITH
RESPECT TO ANY INTELLECTUAL PROPERTY RIGHT OR OTHER INTANGIBLE PROPERTY, THAT A
PARTY OR ONE OF ITS AFFILIATES OWNS OR HAS A LICENSE OR SUBLICENSE TO SUCH ITEM
OR RIGHT, AND HAS THE ABILITY TO GRANT ACCESS, LICENSE OR SUBLICENSE IN OR TO
SUCH RIGHT WITHOUT VIOLATING THE TERMS OF ANY AGREEMENT OR ARRANGEMENT WITH ANY
THIRD PARTY.
2.12
"DILIGENT EFFORTS" SHALL MEAN THE CARRYING OUT OF
OBLIGATIONS OR TASKS CONSISTENT WITH THE COMMERCIALLY REASONABLE PRACTICES OF
THE PHARMACEUTICAL INDUSTRY FOR THE DEVELOPMENT OR COMMERCIALIZATION OF A
PHARMACEUTICAL PRODUCT HAVING SIMILAR MARKET POTENTIAL OR PROFIT POTENTIAL AS
THE PRODUCT, BASED ON CONDITIONS THEN PREVAILING.
DILIGENT EFFORTS
3
REQUIRES THAT THE PARTY, AT A MINIMUM:
(A) DETERMINE THE GENERAL INDUSTRY
PRACTICES WITH RESPECT TO THE APPLICABLE ACTIVITIES, (B) REASONABLY PROMPTLY
ASSIGN RESPONSIBILITY FOR SUCH OBLIGATIONS TO SPECIFIC EMPLOYEE(S) WHO ARE HELD
ACCOUNTABLE FOR PROGRESS AND MONITOR SUCH PROGRESS ON AN ON-GOING BASIS, (C) SET
AND CONSISTENTLY SEEK TO ACHIEVE SPECIFIC AND MEANINGFUL OBJECTIVES FOR CARRYING
OUT SUCH OBLIGATIONS, AND (D) MAKE AND IMPLEMENT DECISIONS AND ALLOCATE
RESOURCES DESIGNED TO ADVANCE PROGRESS WITH RESPECT TO SUCH OBJECTIVES.
2.13
"FDA" MEANS THE UNITED STATES FOOD AND DRUG
ADMINISTRATION OR ANY SUCCESSORS TO ITS RESPONSIBILITIES WITH RESPECT TO
PHARMACEUTICAL PRODUCTS SUCH AS THE PRODUCTS.
2.14
"FIRST COMMERCIAL SALE" MEANS THE INITIAL
TRANSFER BY OR ON BEHALF OF LICENSEE OR ITS SUBLICENSEES OF PRODUCTS IN EXCHANGE
FOR CASH OR SOME EQUIVALENT TO WHICH VALUE CAN BE ASSIGNED FOR THE PURPOSE OF
DETERMINING NET SALES REVENUE.
2.15
"GOVERNMENT AUTHORITY" MEANS ANY COURT, AGENCY,
DEPARTMENT, AUTHORITY OR OTHER INSTRUMENTALITY OF ANY FEDERAL, STATE, COUNTY,