BY EPIX ON OR AFTER THE EFFECTIVE DATE IN THE
CONDUCT OF ACTIVITIES OUTSIDE OF THE RESEARCH PROGRAM.
1.15
"FIELD" MEANS THE DIAGNOSIS OR CHARACTERIZATION
OF DISEASES OR CONDITIONS IN HUMANS THROUGH THE USE OF MAGNETIC RESONANCE
IMAGING; PROVIDED, HOWEVER, THAT THE FIELD SHALL NOT INCLUDE: (I) ANY PRODUCTS
THAT ARE SUBJECT TO A LICENSE GRANTED UNDER THE THROMBUS DEVELOPMENT AGREEMENT
ENTERED INTO BY AND BETWEEN THE PARTIES AS OF THE EFFECTIVE DATE OR THE
STRATEGIC COLLABORATION AGREEMENT BETWEEN EPIX AND SCHERING DATED JUNE 9, 2000,
OR (II) ANY PRODUCTS ALREADY COMMERCIALIZED OR IN PRECLINICAL OR CLINICAL
DEVELOPMENT PRIOR TO THE EFFECTIVE DATE AS SET FORTH ON EXHIBIT 1.15 ,
OR (III)
ANY PRODUCT, COMPOUND OR TECHNOLOGY BEING SUBJECT TO A CONTRACT OR COLLABORATION
WITH A THIRD PARTY WHICH IS ALREADY IN EXISTENCE PRIOR TO THE EFFECTIVE DATE, OR
ANY EXTENSION OR AMENDMENT THEREOF, EXCEPT FOR THOSE CONTRACTS AS TO BE
DETERMINED BY THE RSC.
1.16
"FDA" MEANS THE UNITED STATES FOOD AND DRUG
ADMINISTRATION OR ANY SUCCESSOR AGENCY.
1.17
"FIRST COMMERCIAL SALE" MEANS THE DATE OF THE
FIRST SALE OF A LICENSED PRODUCT IN THE ORDINARY COURSE OF BUSINESS IN ANY
COUNTRY BY A PARTY OR AN AFFILIATE OR SUBLICENSEE OF SUCH PARTY AFTER ALL
MARKETING, PRICING AND/OR REIMBURSEMENT APPROVALS OF THE COMPETENT HEALTH
AUTHORITY(IES) OF SUCH COUNTRY REQUIRED FOR SALE OF SUCH PRODUCT IN SUCH COUNTRY
HAVE BEEN OBTAINED.
1.18
"FULL TIME EQUIVALENT" OR "FTE" MEANS ONE (1) OR
MORE QUALIFIED EMPLOYEE(S), CONTRACTOR(S) OR AGENT(S) OF A PARTY WHO,
COLLECTIVELY, SPEND TIME AND EFFORT WORKING ON A SPECIFIC PROJECT OR TASK
EQUIVALENT TO THE TIME AND EFFORT OF ONE (1) FULL-TIME EMPLOYEE FOR ONE (1)
YEAR.
1.19
"GENERAL AND ADMINISTRATIVE EXPENSES" SHALL MEAN
ALL DIRECT AND INDIRECT EXPENSES INCURRED BY SCHERING AND EPIX IN CONNECTION
WITH DEPARTMENTAL UNITS THAT ARE NOT DIRECTLY ENGAGED IN THE RESEARCH,
DEVELOPMENT, MANUFACTURING, OR SALES AND MARKETING OF JOINT TECHNOLOGY, LEAD
COMPOUNDS, DEVELOPMENT CANDIDATES AND LICENSED PRODUCTS.
GENERAL AND
ADMINISTRATIVE EXPENSES SHALL INCLUDE, BUT NOT BE LIMITED TO, CHARGES FALLING
WITHIN THE FOLLOWING, GROUPS: FINANCE, PROCUREMENT, ORDER ENTRY, CORPORATE
ADMINISTRATION, LEGAL (BOTH EXTERNAL AND INTERNAL EXPENSES), HUMAN RESOURCES,
BUSINESS DEVELOPMENT AND LICENSING AND INVESTOR RELATIONS.
"GENERAL AND
ADMINISTRATIVE EXPENSES" SHALL EXCLUDE THE FOLLOWING GROUPS OF CHARGES: CLINICAL
TRIAL INSURANCE COSTS, FACILITIES AND INFORMATION TECHNOLOGY.
SUCH EXPENSES
SHALL BE DETERMINED IN ACCORDANCE WITH GAAP, CONSISTENTLY APPLIED.
1.20
"IND" MEANS AN INVESTIGATIONAL NEW DRUG
APPLICATION, AS DEFINED IN THE UNITED STATES FOOD, DRUG AND COSMETIC ACT AND
APPLICABLE REGULATIONS PROMULGATED THEREUNDER, OR THE EQUIVALENT IN ANY OTHER
COUNTRY.
1.21
"INDEMNITEE" HAS THE MEANING SET FORTH IN SECTION
12.4.
4
1.22
"INDEMNITOR" HAS THE MEANING SET FORTH IN SECTION
12.4.
1.23
"JOINT KNOW-HOW" MEANS ALL KNOW-HOW THAT IS: (A)
DEVELOPED OR CONCEIVED BY EPIX AND/OR SCHERING AFTER THE EFFECTIVE DATE IN THE
CONDUCT OF ACTIVITIES WITHIN THE RESEARCH PROGRAM, AND/OR (B) CONTROLLED JOINTLY
BY EPIX AND SCHERING.
1.24
"JOINT PATENT RIGHTS" MEANS PATENT RIGHTS
CONTROLLED BY SCHERING AND EPIX AND HAVING CLAIMS COVERING JOINT KNOW-HOW,