TO THE EXTENT PERMISSIBLE
UNDER ALNYLAM'S AGREEMENTS WITH ITS ASIAN PARTNER, THE ASIAN PARTNER HAS AN
OBLIGATION TO DISCLOSE TO ALNYLAM, AND TO PERMIT ALNYLAM TO DISCLOSE TO CUBIST,
AND PERMIT CUBIST TO USE FOR THE PURPOSES SET FORTH IN THIS AGREEMENT,
INFORMATION AND RECORDS OF ALL WORK DONE AND RESULTS ACHIEVED BY SUCH ASIAN
PARTNER IN THE PERFORMANCE OF DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF
LICENSED PRODUCTS FOR ASIA, INCLUDING THE INFORMATION SPECIFIED IN THIS
SECTION 4.3(B) AND THE INFORMATION SPECIFIED IN SECTION 4.3(C) AND SECTION 4.8.
ALNYLAM SHALL USE DILIGENT EFFORTS TO REQUIRE ITS
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
31
Asian Partner to permit the disclosures of information and records to Cubist
contemplated by the preceding sentence.
(C)
IN ADDITION TO THE OTHER DISCLOSURE OBLIGATIONS SET FORTH IN THIS
SECTION 4.3, AT TIMES AND IN A MANNER TO BE REASONABLY AGREED BY THE PARTIES,
EACH PARTY SHALL DISCLOSE TO THE OTHER PARTY A WRITTEN SUMMARY, IN A FORM
MUTUALLY AGREED BY THE PARTIES, OF CLINICAL DATA WITH RESPECT TO LICENSED
PRODUCTS GENERATED BY OR UNDER AUTHORITY OF SUCH PARTY OR ANY RELATED PARTY
SINCE THE LAST SUCH DISCLOSURE.
UPON THE REQUEST OF EITHER PARTY, THE OTHER
PARTY SHALL PROVIDE PROMPT AND COMPLETE ACCESS TO, AND THE RIGHT TO USE FOR
PURPOSES OF THE ACTIVITIES FOR WHICH SUCH REQUESTING PARTY IS LICENSED
HEREUNDER, ANY CLINICAL REGULATORY FILINGS AND SAFETY DATA GENERATED BY SUCH
PARTY OR ITS RELATED PARTIES; PROVIDED THAT IN ANY SUCH CASE THE REQUESTING
PARTY PROVIDES NOTICE TO THE OTHER PARTY REASONABLY IN ADVANCE AND REIMBURSES
THE OTHER PARTY FOR ANY REASONABLY INCURRED COPYING COSTS OF PROVIDING SUCH
ACCESS.
EACH PARTY MUST PROVIDE ACCESS TO ITS RELATED PARTY'S CLINICAL
REGULATORY FILINGS AND SAFETY DATA ON THE SAME BASIS AS IF THE RELATED PARTIES
WERE SUCH PARTY.
IF REQUESTED BY EITHER PARTY OR THE JSC, THE PARTIES SHALL
DISCUSS ANY ISSUES RELATING TO SUCH CLINICAL REGULATORY FILINGS OR SAFETY DATA
PROVIDED BY A PARTY TO THE OTHER PARTY.
IN ADDITION TO THE FOREGOING, IF
REQUIRED BY A REGULATORY AUTHORITY(IES) OR IF IT IS REASONABLY NECESSARY FOR A
PARTY OR ITS RELATED PARTY(IES) TO HAVE ACCESS TO THE UNDERLYING RAW DATA, CASE
REPORT FORMS OR OTHER ORIGINAL DOCUMENTS (INCLUDING LABORATORY NOTEBOOKS)
GENERATED BY OR ON BEHALF OF THE OTHER PARTY OR ITS RELATED PARTY(IES), THEN
SUCH OTHER PARTY SHALL PROVIDE, OR CAUSE TO BE PROVIDED, ACCESS TO THE
ORIGINALS, OF SUCH ITEMS.
SECTION 4.4
JOINT DEVELOPMENT COSTS.
(A)
THE PARTIES SHALL SHARE DEVELOPMENT COSTS AS FOLLOWS:
(I) ALL
DEVELOPMENT COSTS SOLELY FOR THE PROFIT-SHARE TERRITORY SHALL BE SHARED EQUALLY
BY THE PARTIES, AND (II) ALL DEVELOPMENT COSTS INCURRED WITH RESPECT TO
DEVELOPMENT OF LICENSED PRODUCT FOR THE PROFIT-SHARE TERRITORY BUT GENERATING
DATA OR OTHER KNOW-HOW THAT ALSO HAS APPLICABILITY IN THE ROYALTY TERRITORY
SHALL BE CONTINUE TO BE SHARED EQUALLY BY THE PARTIES EXCEPT THAT ANY
INCREMENTAL COSTS ASSOCIATED SPECIFICALLY WITH ANY DEVELOPMENT ACTIVITIES NOT
REQUIRED FOR THE PROFIT-SHARE TERRITORY SHALL BE []*.