DEVELOPMENT OF AN UNDESIRABLE
MEDICAL CONDITION OR THE DETERIORATION OF A PRE-EXISTING MEDICAL CONDITION
FOLLOWING OR DURING EXPOSURE TO THE PRODUCT, WHETHER OR NOT CONSIDERED CAUSALLY
RELATED TO THE PRODUCT, THE EXACERBATION OF ANY PRE-EXISTING
CONDITION(S) OCCURRING DURING THE USE OF THE PRODUCT, OR ANY OTHER ADVERSE
EXPERIENCE OR ADVERSE DRUG EXPERIENCE DESCRIBED IN THE FDA'S INVESTIGATIONAL NEW
DRUG SAFETY REPORTING AND NEW DRUG APPLICATION POSTMARKETING REPORTING
REGULATIONS, 21 C.F.R. 312.32 AND 314.80, RESPECTIVELY, AS THEY MAY BE AMENDED
FROM TIME TO TIME.
FOR PURPOSES OF THIS AGREEMENT, "UNDESIRABLE MEDICAL
CONDITION" SHALL INCLUDE SYMPTOMS (E.G., NAUSEA, CHEST PAIN), SIGNS (E.G.,
TACHYCARDIA, ENLARGED LIVER) OR THE ABNORMAL RESULTS OF AN INVESTIGATION (E.G.,
LABORATORY FINDINGS, ELECTROCARDIOGRAM), INCLUDING UNFAVORABLE SIDE EFFECTS,
TOXICITY, INJURY,
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
5
OVERDOSE, SENSITIVITY REACTIONS OR FAILURE OF THE PRODUCT TO EXHIBIT ITS
EXPECTED PHARMACOLOGIC/BIOLOGIC EFFECT.
(C)
"AFFILIATE" MEANS, WITH RESPECT TO ANY PERSON, ANY OTHER
PERSON THAT DIRECTLY, OR INDIRECTLY THROUGH ONE OR MORE INTERMEDIARIES,
CONTROLS, IS CONTROLLED BY OR IS UNDER COMMON CONTROL WITH SUCH FIRST PERSON.
(D)
"AGENCY" MEANS ANY GOVERNMENTAL OR REGULATORY AUTHORITY IN
THE TERRITORY.
(E)
"AGREED BASELINE ADJUSTMENT" HAS THE MEANING ASCRIBED TO
SUCH TERM IN SECTION 6.1(B).
(F)
"AGREEMENT" HAS THE MEANING ASCRIBED TO SUCH TERM IN THE
PREAMBLE.
(G)
"ALLIANCE MANAGER" HAS THE MEANING ASCRIBED TO SUCH TERM IN
ARTICLE VII.
(H)
"ANNUAL AMOUNT DUE" HAS THE MEANING ASCRIBED TO SUCH TERM IN
EXHIBIT A.
(I)
"ANNUAL BASELINE AMOUNT" HAS THE MEANING ASCRIBED TO SUCH
TERM IN EXHIBIT A.
(J)
"ANNUAL BASELINE SALES" HAS THE MEANING ASCRIBED TO SUCH
TERM IN EXHIBIT A.
(K)
"APPLICABLE LAW" MEANS (I) THE AMERICAN MEDICAL ASSOCIATION
GUIDELINES ON GIFTS TO PHYSICIANS FROM INDUSTRY, (II) THE PHRMA CODE ON
INTERACTIONS WITH HEALTHCARE PROFESSIONALS, AND (III) ALL FEDERAL, STATE AND
LOCAL LAWS, AND THE RULES, REGULATIONS, GUIDELINES AND GUIDANCES OF ALL
AGENCIES, IN EFFECT FROM TIME TO TIME, APPLICABLE TO THE MANUFACTURE, MARKETING,
PROMOTION, DISTRIBUTION AND SALE OF THE PRODUCT IN THE TERRITORY, INCLUDING THE
ACT, THE PDMA, STATE AND FEDERAL ANTI-KICKBACK STATUTES, FALSE CLAIMS STATUTES,
STATUTES THAT GOVERN PRICE REPORTING AND REIMBURSEMENT, STATUTES THAT GOVERN
MARKETING DISCLOSURE, AND ALL RULES AND REGULATIONS RELATED THERETO, IN EACH
CASE IN THE TERRITORY.
(L)
"ASTRAZENECA" HAS THE MEANING ASCRIBED TO SUCH TERM IN THE
PREAMBLE.
(M)
"ASTRAZENECA CSD MATERIALS" HAS THE MEANING ASCRIBED TO SUCH
TERM IN SECTION 3.2(B).
(N)
"ASTRAZENECA HOUSEMARKS" MEANS (I) THE TRADEMARKS OF
ASTRAZENECA AND ITS AFFILIATES SET FORTH ON EXHIBIT G-2 AND ANY PENDING OR
FUTURE TRADEMARK REGISTRATIONS, APPLICATIONS AND UNREGISTERED TRADEMARK RIGHTS,
IN EACH CASE RELATING TO SUCH
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
6
TRADEMARKS, AND (II) ANY CURRENT OR FUTURE MODIFICATIONS OR VARIANTS OF ANY OF
THE FOREGOING RIGHTS.
(O)
"ASTRAZENECA INDEMNIFIED PARTIES" HAS THE MEANING ASCRIBED TO
SUCH TERM IN SECTION 14.3.
(P)
[]*.
(Q)
"AVERAGE SELLING PRICE" MEANS THE AVERAGE SELLING PRICE OF A
PRODUCT AS REPORTED BY THE CENTERS FOR MEDICARE AND