any Off-Label Information to any
Third Party []*.
Cubist shall not make any knowingly untrue or misleading
statements or comments about (i) the Product, or (ii) AstraZeneca or its
Affiliates or any of their respective employees.
3.8
Requests for Medical Information.
(A)
NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR THE BUSINESS
POLICIES TO THE CONTRARY, NO PROGRAM EMPLOYEE MAY RESPOND TO OR OTHERWISE
COMMUNICATE WITH ANY TARGET PRESCRIBER OR OTHER THIRD PARTY WITH RESPECT TO ANY
OFF-LABEL INFORMATION []*.
(B)
ASTRAZENECA SHALL HAVE THE EXCLUSIVE RIGHT TO RESPOND IN THE
ORDINARY COURSE OF ITS BUSINESS, TO ALL QUESTIONS OR REQUESTS FOR INFORMATION
ABOUT THE PRODUCT MADE BY ANY
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
27
MEDICAL PROFESSIONALS OR ANY OTHER PERSON TO THE REPRESENTATIVES OR CSDS, THAT
(I) WARRANT A RESPONSE BEYOND THE UNDERSTANDING OR KNOWLEDGE OF THE
REPRESENTATIVE OR CSD, AS APPLICABLE, OR (II) ARE OUTSIDE THE SCOPE OF THE
PRODUCT LABELS AND INSERTS OR THE PROMOTIONAL MATERIALS (EACH, A "PIR");
PROVIDED THAT []*.
CUBIST SHALL PROMPTLY COMMUNICATE ALL PIRS (OTHER THAN ANY
PIR FOR WHICH A RESPONSE IS PROVIDED BY A CSD PURSUANT TO SECTION 3.8(A)) TO
ASTRAZENECA AS FOLLOWS:
BY TELEPHONE AT []* (OR SUCH OTHER NUMBER AS
ASTRAZENECA MAY DESIGNATE FROM TIME TO TIME) (WHICH UNPUBLISHED NUMBER IS NOT TO
BE PROVIDED BY CUBIST TO THIRD PARTIES), 8:00 A.M. - 6:00 P.M. ET, MONDAY
THROUGH FRIDAY, EXCLUDING HOLIDAYS, OR COMPLETING AN ELECTRONIC WEB PIR FORM AT
[]*, OR SUCH OTHER WEBSITE ADDRESS AS ASTRAZENECA MAY DESIGNATE FROM TIME TO
TIME.
CUBIST SHALL HAVE THE RIGHT AT ITS OPTION TO INCLUDE A HYPERLINK TO SUCH
WEBSITE ADDRESS ON CUBIST'S INTERNAL WEBSITE FOR THE PRODUCT IN A FORM AND
MANNER TO BE MUTUALLY AGREED UPON BY THE PARTIES (SUCH AGREEMENT NOT TO BE
UNREASONABLY WITHHELD, CONDITIONED OR DELAYED).
CUBIST MAY ALSO PROVIDE THE
FOLLOWING PUBLISHED NUMBER 1-800-236-9933 (OR SUCH OTHER NUMBER AS ASTRAZENECA
MAY DESIGNATE FROM TIME TO TIME) TO MEDICAL PROFESSIONALS (AND ANY OTHER PERSONS
WHO MAKE ANY PIRS) FOR SUCH PERSONS TO CONTACT THE ASTRAZENECA INFORMATION
CENTER DIRECTLY (PROVIDED THAT THE FOREGOING SHALL NOT LIMIT CUBIST'S
OBLIGATIONS SET OUT ABOVE IN THIS SECTION 3.8(B) WITH RESPECT TO ANY PIRS).
CUBIST MAY AT ITS OPTION REQUIRE A SIGNED DOCUMENT FROM ANY PERSON MAKING AN
UNSOLICITED INQUIRY BEFORE ACCEPTING THE INQUIRY.
(C)
IN CONNECTION WITH THE PROGRAM, INCLUDING THE PROMOTION OF THE
PRODUCT, CUBIST MAY INFORM TARGET PRESCRIBERS OR OTHER MEDICAL PROFESSIONALS
THAT THEY MAY CONTACT THE ASTRAZENECA INFORMATION CENTER AT 1-800-236-9933 (OR
SUCH OTHER NUMBER AS ASTRAZENECA MAY DESIGNATE FROM TIME TO TIME) REGARDING
QUESTIONS OR REQUESTS FOR INFORMATION ABOUT THE PRODUCT.
3.9
Compliance with Laws and Policies.
(A)
CUBIST SHALL NOTIFY ASTRAZENECA'S ALLIANCE MANAGER IN WRITING IN
ADVANCE OF ANY MATERIAL CHANGES TO THE []*.
ANY MATERIAL CHANGE TO A []* SHALL
REQUIRE []*; PROVIDED THAT IF CUBIST SUBMITS SUCH A CHANGE TO A []* TO
ASTRAZENECA'S ALLIANCE MANAGER FOR ASTRAZENECA'S REVIEW AND APPROVAL,
ASTRAZENECA SHALL NOTIFY CUBIST IN WRITING WITHIN