ITS AFFILIATES OR
SUBLICENSEES TO A THIRD PARTY IN THE FIELD (BUT NOT INCLUDING SALES BETWEEN THE
PURCHASER AND ITS AFFILIATES WHERE THE PRODUCT IS INTENDED FOR RESALE) LESS THE
FOLLOWING REDUCTIONS RELATING TO SUCH SALES:
(I) TRADE, QUANTITY AND CASH DISCOUNTS OR REBATES, WHICH ARE NOT ALREADY
REFLECTED IN THE AMOUNT INVOICED;
*CONFIDENTIAL TREATMENT REQUESTED
2
(II) ANY ADJUSTMENTS OR ALLOWANCES ON ACCOUNT OF PRICE ADJUSTMENTS, BILLING
ERRORS, REJECTED GOODS, DAMAGED GOODS, RETURNS AND WITHDRAWAL, RECALL OR
RELABELING OF PRODUCT;
(III) CREDITS, VOLUME REBATES, CHARGE-BACK AND PRIME VENDOR REBATES,
REIMBURSEMENTS OR SIMILAR PAYMENTS GRANTED OR GIVEN TO, OR RELATED
ADMINISTRATIVE, PROCESSING OR OTHER FEES CHARGED TO, WHOLESALERS AND OTHER
DISTRIBUTORS, BUYING GROUPS, HEALTH CARE INSURANCE CARRIERS, PHARMACY BENEFIT
MANAGEMENT COMPANIES, HEALTH MAINTENANCE ORGANIZATIONS OR OTHER INSTITUTIONS OR
HEALTH CARE ORGANIZATIONS, WHICH ARE NOT ALREADY REFLECTED IN THE AMOUNT
INVOICED;
(IV)
ANY TAX, TARIFF, CUSTOMS DUTY, EXCISE OR OTHER DUTY OR OTHER GOVERNMENTAL
CHARGE INCLUDING, WITHOUT LIMITATION, VALUE ADDED TAXES(OTHER THAN A TAX ON
INCOME) LEVIED ON THE MANUFACTURE, SALE, TRANSPORTATION OR DELIVERY OF THE
PRODUCT AND REMITTED TO THE APPLICABLE TAXING AUTHORITY;
(V) PAYMENTS OR REBATES PAID IN CONNECTION WITH SALES OF THE PRODUCT TO ANY
GOVERNMENTAL OR REGULATORY AUTHORITY IN RESPECT OF ANY STATE OR FEDERAL
MEDICARE, MEDICAID OR SIMILAR PROGRAMS, OR OTHER MANAGED CARE PROGRAMS, WHICH
ARE NOT ALREADY REFLECTED IN THE AMOUNT INVOICED;
(VI) FREIGHT, POSTAGE, HANDLING, SHIPPING, INSURANCE OR OTHER TRANSPORTATION
COSTS CHARGED TO THE CUSTOMER WHETHER INVOICED SEPARATELY OR INCLUDED WITHIN THE
SELLING PRICE; AND
(VII) AMOUNTS ALLOCATED FOR BAD DEBT DETERMINED BY GENERALLY ACCEPTED ACCOUNTING
PRINCIPLES CONSISTENTLY APPLIED.
FOR PURPOSES OF THIS DEFINITION, THE PRODUCT SHALL BE CONSIDERED "SOLD" AND
"REDUCTIONS" ALLOWED WHEN SO RECORDED IN THE PURCHASER OR ITS AFFILIATES OR
SUBLICENSEES (AS THE CASE MAY BE) CONSOLIDATED AND CONSOLIDATING FINANCIAL
STATEMENTS PREPARED IN ACCORDANCE WITH GENERALLY ACCEPTED ACCOUNTING PRINCIPLES.
THE FIRST SALE TO A THIRD PARTY IN AN ARMS-LENGTH TRANSACTION SHALL BE REGARDED
AS THE FIRST SALE FOR THE PURPOSE OF CALCULATING NET SALES.
SECTION 1.13
"NDA" MEANS A NEW DRUG APPLICATION AND AMENDMENTS THERETO
FILED PURSUANT TO THE REQUIREMENTS OF THE FDA, AS DEFINED IN 21 C.F.R. § 314 ET
SEQ., FOR FDA APPROVAL OF A NEW DRUG PRODUCT.
SECTION 1.14
"ORDER" MEANS ANY WRIT, JUDGMENT, DECREE, INJUNCTION,
AWARD OR SIMILAR ORDER OF ANY GOVERNMENTAL AUTHORITY, INCLUDING ANY AWARD IN AN
ARBITRATION PROCEEDING (IN EACH CASE, WHETHER PRELIMINARY OR FINAL).
SECTION 1.15
"PARTIES" MEANS THE PURCHASER AND THE COMPANY.
SECTION 1.16
"PARTY" MEANS THE PURCHASER OR THE COMPANY, AS THE
CONTEXT MAY REQUIRE.
SECTION 1.17
"PATENT RIGHTS" MEANS UNITED STATES AND FOREIGN PATENTS
AND PATENT APPLICATIONS AND ALL SUBSTITUTIONS, DIVISIONS, CONTINUATIONS,
CONTINUATIONS-IN-PART, REQUESTS FOR CONTINUED EXAMINATIONS, REISSUES,
REEXAMINATIONS AND EXTENSIONS THEREOF.
SECTION 1.18
"PERSON" MEANS ANY NATURAL PERSON OR ANY CORPORATION,
COMPANY, PARTNERSHIP, JOINT VENTURE, FIRM OR OTHER ENTITY, INCLUDING WITHOUT
LIMITATION A PARTY.
*CONFIDENTIAL TREATMENT REQUESTED
3
SECTION 1.19
"PRODUCT" AND COGNATES THEREOF MEAN IMAGIFYTM
(PERFLUBUTANE POLYMER MICROSPHERES) FOR INJECTABLE SUSPENSION IN ALL
FORMULATIONS AND