THE LIKE, THE SECRECY OF WHICH
CONFERS A COMPETITIVE ADVANTAGE UPON THAT PARTY. AS USED HEREIN, CONFIDENTIAL
INFORMATION SHALL NOT INCLUDE RIGHTS UNDER PATENT RIGHTS (BUT DOES INCLUDE THE
SUBJECT MATTER DISCLOSED IN NON-PUBLISHED APPLICATIONS).
1.9
"CONTROL"
SHALL MEAN POSSESSION OF THE
POWER AND AUTHORITY TO GRANT A LICENSE OR SUBLICENSE, OF OR WITHIN THE SCOPE SET
FORTH IN THIS AGREEMENT, WITHOUT VIOLATING THE TERMS OF ANY AGREEMENT OR OTHER
ARRANGEMENT WITH ANY THIRD PARTY OR ANY APPLICABLE LAWS OR REGULATIONS, AND
WITHOUT THE NEED FOR ADDITIONAL PAYMENTS BY SUPERGEN AS A RESULT OF THE LICENSE
HEREIN.
1.10
"DECITABINE" SHALL MEAN THE COMPOUND IDENTIFIED
IN EXHIBIT 1.10, AND ALL [*], [*] AND [*] OF THE COMPOUND IDENTIFIED IN EXHIBIT
1.10,. [*] AND [*] OF THE COMPOUND IDENTIFIED IN EXHIBIT 1.10 SHALL ONLY BE
INCLUDED TO THE EXTENT THEY CONSTITUTE THE SAME ACTIVE INGREDIENT AS THE
COMPOUND IDENTIFIED IN EXHIBIT 1.10.
1.11
"DERIVATIVE PATENTS" SHALL MEAN ALL PATENT RIGHTS
THAT CLAIM AN INVENTION THAT IS NOT OWNED SOLELY BY SUPERGEN AND WHICH (I) WAS
INVENTED OR CREATED BY OR ON BEHALF OF MGI, ITS AFFILIATE, OR ANY LICENSEE IN
CONNECTION WITH THE DEVELOPMENT OR MANUFACTURE OF ANY LICENSED PRODUCT; OR (II)
INCORPORATES, EMBODIES OR IS OTHERWISE BASED UPON OR DERIVED FROM DECITABINE, OR
THE LICENSED PATENTS, SUPPORTING DATA, REGULATORY DOCUMENTATION, OR OTHER
CONFIDENTIAL INFORMATION OF SUPERGEN, OR DEVELOPED IN CONNECTION WITH THE
EXERCISE OF RIGHTS WITH RESPECT THERETO.
1.12
"DEVELOP" AND DEVELOPMENT" MEANS ALL ACTIVITIES
RELATED TO OBTAINING REGULATORY APPROVALS FOR LICENSED PRODUCT IN THE TERRITORY,
INCLUDING PRECLINICAL TESTING, TOXICOLOGY, FORMULATION, CLINICAL TRIALS, QUALITY
OF LIFE ASSESSMENTS, REGULATORY AFFAIRS, AND FURTHER ACTIVITIES RELATED TO
DEVELOPMENT OF LICENSED PRODUCT TO A STAGE READY FOR COMMERCIALIZATION THEREOF,
INCLUDING PRE-MARKETING AND SALES COSTS AND ACTIVITIES, RESEARCH, PROCESS
DEVELOPMENT AND MANUFACTURING SCALE-UP.
3
It is understood that Development includes ongoing clinical trials of Licensed
Product conducted after the initial Regulatory Approval of Licensed Product,
including, without limitation, to obtain further Regulatory Approval for
expanded labeling or approval for new indications.
1.13
"DEVELOPMENT COSTS" SHALL MEAN THE TOTAL OF (I)
THE ACTUAL HOURS EXPENDED BY DEVELOPMENT PERSONNEL, MULTIPLIED BY THE
DEVELOPMENT RATE IN EFFECT AT THE TIME SUCH HOURS ARE INCURRED FOR THE
PARTICULAR INDIVIDUAL; (II) MATERIAL COSTS; (III) SUB-CONTRACTOR COSTS; AND (IV)
OTHER DIRECT AND OUT-OF -POCKET EXPENSES INCURRED IN ORDER TO PERFORM LICENSED
PRODUCT DEVELOPMENT ACTIVITIES.
1.14
"DEVELOPMENT PERSONNEL" SHALL MEAN EMPLOYEES OF A
PARTY ASSIGNED (FULL- OR PART-TIME) TO CONDUCT DEVELOPMENT OF A LICENSED PRODUCT
IN ACCORDANCE WITH THIS AGREEMENT, INCLUDING SCIENTISTS, RESEARCH STAFF, QUALITY
CONTROL AND ASSURANCE PERSONNEL, TECHNICIANS OR THE LIKE, BUT EXCLUDING
NON-TECHNICAL, NON-PROFESSIONAL PERSONNEL SUCH AS SECRETARIAL OR ADMINISTRATIVE
STAFF.
1.15
"DEVELOPMENT RATE" SHALL MEAN WITH RESPECT TO ANY
INDIVIDUAL DEVELOPMENT PERSONNEL, THE SUM OF THE ACTUAL (I) ANNUAL SALARY, (II)
EMPLOYEE BENEFITS (INCLUDING BONUS, PAYROLL TAXES, INSURANCES AND OTHER DIRECT
BENEFIT COSTS) AND (III) ALLOCATED OVERHEAD, DIVIDED BY ONE THOUSAND EIGHT
HUNDRED SEVENTY TWO (1872). THE DEVELOPMENT RATE DOES NOT INCLUDE MATERIAL
COSTS, SUB-CONTRACTOR COSTS AND OTHER