CONDUCTED HEREUNDER;
(AA)
"PRIME RATE" SHALL MEAN THE RATE OF INTEREST
THAT THE ROYAL BANK OF CANADA HAS ANNOUNCED AS THE PRIME RATE AS THE REFERENCE
RATE TO DETERMINE INTEREST PAYABLE ON COMMERCIAL LOANS TO ITS MOST CREDITWORTHY
CUSTOMERS ON THE LAST BUSINESS DAY OF THE CALENDAR QUARTER IMMEDIATELY PRECEDING
THE DATE OF THE AMOUNT DUE UNDER THE AGREEMENT;
(BB)
"RECALL" SHALL MEAN:
(I)
ANY ACTION TO RECOVER POSSESSION OF ANY
LICENSED PRODUCT SHIPPED TO THIRD PARTIES (FOR THIS PURPOSE, THE DEFINITION OF
THIRD PARTIES SHALL NOT INCLUDE ANY AFFILIATE, WHERE "CONTROL" IN THE DEFINITION
OF AFFILIATE SHALL MEAN DIRECT OR INDIRECT BENEFICIAL OWNERSHIP OF [*] INTEREST
IN THE INCOME OF A PERSON OR SUCH OTHER RELATIONSHIP AS, IN FACT, CONSTITUTES
ACTUAL CONTROL); OR
(II)
ANY ACTION BY THE FDA OR ANY OTHER
APPLICABLE GOVERNMENTAL OR REGULATORY AGENCY IN ANY JURISDICTION, TO DETAIN OR
DESTROY QUANTITIES OF ANY LICENSED PRODUCT INTENDED FOR COMMERCIAL SALE OR
DISTRIBUTION OF SUCH LICENSED PRODUCT OR TO PREVENT RELEASE OF SUCH LICENSED
PRODUCT FOR COMMERCIAL SALE OR DISTRIBUTION.
"Recalled" and "Recalling" shall have comparable meanings;
(CC)
"REGULATORY APPROVAL" SHALL MEAN ANY AND ALL
APPROVALS (INCLUDING PRICING AND REIMBURSEMENT APPROVALS), LICENSES,
REGISTRATIONS OR AUTHORIZATIONS OF ANY FEDERAL, STATE, PROVINCIAL OR LOCAL
REGULATORY AGENCY, DEPARTMENT, BUREAU OR OTHER GOVERNMENTAL ENTITY, NECESSARY
FOR THE COMMERCIAL MANUFACTURE, USE, STORAGE, IMPORT, TRANSPORT, MARKETING, AND
SALE OR DISTRIBUTION OF A LICENSED PRODUCT IN A COUNTRY OR REGULATORY
JURISDICTION IN THE TERRITORY IN THE FIELD;
(DD)
"SUBLICENSING MILESTONE REVENUE" SHALL MEAN ALL
REVENUES (INCLUDING PROFITS ON THE COMMERCIAL MANUFACTURE BY NEORX OR ITS
AFFILIATES OF LICENSED COMPOUNDS AND LICENSED PRODUCTS), RECEIPTS, MONIES,
4
MILESTONE PAYMENTS AND RESEARCH FEES (IN RESPECT OF RESEARCH FEES, ONLY TO THE
EXTENT THAT SAME ARE IN EXCESS OF REIMBURSEMENT FOR THE DIRECT COSTS AND
INDIRECT COSTS OF RESEARCH AND DEVELOPMENT OR PURSUIT OF REGULATORY APPROVAL
UNDERTAKEN BY NEORX OR ITS AFFILIATES PURSUANT TO A WRITTEN RESEARCH OR
DEVELOPMENT PLAN), PAYMENTS (INCLUDING AMOUNTS RECEIVED FROM THE SALE OF SHARES
IN THE CAPITAL STOCK OF NEORX IN EXCESS OF THE CURRENT MARKET VALUE FOR SUCH
SHARES), LICENSE FEES AND THE FAIR MARKET VALUE OF ALL OTHER CONSIDERATION
COLLECTED OR RECEIVED BY NEORX OR ITS AFFILIATES WHETHER BY WAY OF CASH, OR
CREDIT OR ANY BARTER, BENEFIT, ADVANTAGE, OR CONCESSION RELATING TO ANY
SUBLICENSE AGREEMENTS RELATING TO ANY VALID CLAIMS WHICH FORM A PART OF THE
ANORMED PATENTS LICENSED TO NEORX UNDER SECTION 3.1, THE ANORMED KNOW-HOW
LICENSED TO NEORX UNDER SECTION 3.1, OR OTHERWISE TO ANY LICENSED PRODUCTS.
FOR
THE PURPOSES OF THE DEFINITION OF "SUBLICENSING MILESTONE REVENUE", THE TERM
"INDIRECT COSTS" SHALL MEAN COSTS INCURRED FOR THE BENEFIT OF THE DEVELOPMENT
PROGRAM OR THE COMMERCIALIZATION OF A LICENSED PRODUCT, EXCLUDING DIRECTLY
IDENTIFIED COSTS (DIRECT COSTS), AND INCLUDING FACILITY RENTAL COSTS; UTILITIES
COSTS; LABORATORY AND MANUFACTURING EQUIPMENT DEPRECIATION; AND SALARIES,
VACATION PAY, SICK LEAVE PAY, HEALTH INSURANCE PREMIUMS, FICA TAXES (OR THEIR
EQUIVALENT) AND PENSION COSTS FOR EMPLOYEES, BUT ONLY TO THE EXTENT THAT SUCH
EMPLOYEES' WORK BENEFITS