AND OBLIGATIONS OF CUBIST UNDER THIS
AGREEMENT.
ALNYLAM WILL NOTIFY CUBIST PROMPTLY UPON RECEIVING ANY NOTICE OF
MATERIAL BREACH FROM A PARTY THEREUNDER.
(H)
TO THE KNOWLEDGE OF ALNYLAM, NO THIRD PARTY
IS INFRINGING ANY CLAIMS OF ANY ISSUED PATENTS ENCOMPASSED WITHIN THE ALNYLAM
PATENT RIGHTS BY OFFERING FOR SALE OR SELLING ANY DIRECTLY COMPETITIVE PRODUCT
IN THE TERRITORY.
(I)
THE ALNYLAM PATENT RIGHTS IN THE
TERRITORY THAT ARE PENDING PATENT APPLICATIONS AS OF THE EFFECTIVE DATE ARE
BEING DILIGENTLY PROSECUTED AT THE RESPECTIVE PATENT OFFICES, AND, TO THE
KNOWLEDGE OF ALNYLAM AFTER DUE INQUIRY, THE ALNYLAM PATENT RIGHTS IN THE
TERRITORY THAT ARE GRANTED HAVE BEEN MAINTAINED PROPERLY AND CORRECTLY AND ALL
APPLICABLE FEES HAVE BEEN PAID ON OR BEFORE THE DUE DATE FOR PAYMENT, IN EACH
CASE SUBJECT TO ALNYLAM'S REASONABLE BUSINESS JUDGMENT REGARDING THE MANAGEMENT
OF SUCH PATENT PORTFOLIO.
(J)
TO THE KNOWLEDGE OF ALNYLAM AFTER DUE
INQUIRY, THE DEVELOPMENT AND MANUFACTURE OF LICENSED PRODUCT IN THE TERRITORY TO
DATE HAS BEEN CONDUCTED BY ALNYLAM AND ITS AFFILIATES AND ITS SUBCONTRACTORS, IN
COMPLIANCE (IN ALL MATERIAL RESPECTS) WITH ALL APPLICABLE LAWS.
TO THE
KNOWLEDGE OF ALNYLAM AFTER DUE INQUIRY, NEITHER ALNYLAM NOR ANY OF ITS
AFFILIATES, NOR ANY OF THEIR RESPECTIVE OFFICERS, EMPLOYEES OR AGENTS, HAS MADE
AN UNTRUE STATEMENT OF A MATERIAL FACT OR FRAUDULENT STATEMENT TO ANY REGULATORY
AUTHORITY OR FAILED TO DISCLOSE A MATERIAL FACT REQUIRED TO BE DISCLOSED TO ANY
REGULATORY AUTHORITY.
(K)
EXCEPT AS WOULD NOT HAVE A MATERIAL ADVERSE
EFFECT ON THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF LICENSED PRODUCTS
OR CUBIST'S RIGHTS UNDER THIS AGREEMENT, ALL TESTING AND RESEARCH OF LICENSED
PRODUCTS (EXCLUDING THE MANUFACTURE OF MATERIALS USED IN CLINICAL TRIALS) BY
ALNYLAM AND ITS AFFILIATES HAVE BEEN CONDUCTED IN COMPLIANCE WITH GOOD CLINICAL
PRACTICES AND GOOD LABORATORY PRACTICES APPLICABLE AND REQUIRED AT THE TIME SUCH
ACTIVITY WAS PERFORMED AND ALL MATERIALS USED IN CLINICAL TRIALS OF LICENSED
PRODUCTS BY ALNYLAM AND ITS AFFILIATES HAVE BEEN MANUFACTURED IN COMPLIANCE WITH
GOOD MANUFACTURING PRACTICES APPLICABLE AT THE TIME SUCH ACTIVITY WAS PERFORMED.
(L)
TO THE KNOWLEDGE OF ALNYLAM AFTER DUE
INQUIRY, THERE IS NO MATERIAL MATTER CONCERNING THE SAFETY OR EFFICACY OF ANY
LICENSED PRODUCT AS TO WHICH ALNYLAM HAS NOT PROVIDED CUBIST WITH ACCESS TO ALL
MATERIAL INFORMATION.
ALNYLAM HAS DISCLOSED TO CUBIST OR MADE AVAILABLE TO
CUBIST FOR REVIEW ALL RELEVANT DATA AND DOCUMENTATION IN ITS CONTROL THAT IS
MATERIAL IN ORDER TO ASSESS THE SAFETY AND EFFICACY OF LICENSED PRODUCT.
(M)
THERE ARE NO INQUIRIES, ACTIONS OR OTHER
PROCEEDINGS PENDING BEFORE OR, TO THE KNOWLEDGE OF ALNYLAM, THREATENED BY ANY
REGULATORY AUTHORITY WITH RESPECT TO LICENSED PRODUCT OR ANY FACILITY WHERE A
LICENSED PRODUCT IS MANUFACTURED, AND NEITHER ALNYLAM NOR ITS AFFILIATES HAVE
RECEIVED WRITTEN NOTICE THREATENING ANY SUCH INQUIRY, ACTION OR OTHER
PROCEEDING.
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
71
(N)
EXCEPT FOR DISCLOSURES (I) TO THIRD PARTIES
FOR EVALUATION PURPOSES SUBJECT TO CONFIDENTIALITY OBLIGATIONS, (II) TO
ALNYLAM'S ASIAN PARTNER, (III) TO