or its Affiliates.
(B)
SUBLICENSES. LICENSEE AND ITS AFFILIATES
MAY GRANT SUBLICENSES UNDER THE PATENT RIGHTS WITHOUT THE PRIOR WRITTEN CONSENT
OF THE LICENSOR SOLELY IN THE FIELD OF USE; PROVIDED, HOWEVER, THAT (I) SUCH
SUBLICENSES ARE NO LESS PROTECTIVE OF LICENSOR'S RIGHTS AS THE PROVISIONS SET
FORTH IN THIS AGREEMENT, AND TO THE EXTENT APPLICABLE, SHALL INCLUDE ALL OF THE
RIGHTS AND OBLIGATIONS DUE TO LICENSOR HEREUNDER; AND (II) LICENSEE MAKES
PAYMENTS TO LICENSOR BASED UPON MILESTONES AND SALES OF LICENSED PRODUCTS BY ITS
AFFILIATES AND SUCH SUBLICENSEES IN ACCORDANCE WITH SECTION 3, AS IF SUCH
MILESTONES AND SALES OF LICENSED PRODUCT WERE REACHED AND/OR MADE BY LICENSEE.
(C)
PATENT MARKING. LICENSEE, ITS AFFILIATES
AND ALL SUBLICENSEES SHALL MARK ALL LICENSED PRODUCTS IN ACCORDANCE WITH THE
STATUTES OF ANY COUNTRY WHERE A PATENT APPLICATION HAS BEEN FILED OR A PATENT
ISSUED RELATING TO THE PATENT RIGHTS. TO THE EXTENT THE LICENSED PRODUCT CANNOT
BE MARKED, SUCH MARKING SHALL BE INCLUDED IN THE LITERATURE AND/OR MARKETING
MATERIALS DESCRIBING THE LICENSED PRODUCT.
3.
PAYMENTS.
(A)
MILESTONE PAYMENTS. IN CONSIDERATION OF THE
LICENSES GRANTED HEREIN, LICENSEE SHALL MAKE THE MILESTONE PAYMENTS TO LICENSOR
AS SET FORTH IN SECTION 3.2 OF THE ASA.
(B)
NOTICE OF TRIGGERING EVENTS. LICENSEE SHALL
PROVIDE LICENSOR WITH PROMPT WRITTEN NOTICE OF: (I) THE COMMENCEMENT OF PHASE II
CLINICAL TESTING OF ANY LICENSED PRODUCT; (II) EXECUTION OF ANY AGREEMENT BY AND
BETWEEN LICENSEE OR ITS AFFILIATES AND ANY THIRD PARTY WITH RESPECT TO ANY
PATENT RIGHTS OR A LICENSED PRODUCT; AND (III) THE FIRST COMMERCIAL SALE OF EACH
LICENSED PRODUCT ("FIRST COMMERCIAL SALE").
(C)
BOOKS AND RECORDS. LICENSEE AGREES TO KEEP,
AND SHALL CAUSE ITS AFFILIATES AND SUBLICENSEES TO KEEP, COMPLETE AND ACCURATE
BOOKS OF ACCOUNT AND RECORDS COVERING ALL TRANSACTIONS RELATING TO THIS
AGREEMENT, INCLUDING ANNUAL NET SALES AS REPORTED PURSUANT TO SECTION 3.2 OF THE
ASA. ALL SUCH BOOKS OF ACCOUNT AND RECORDS SHALL BE KEPT AVAILABLE FOR AT LEAST
TWO (2) YEARS AFTER THE TERMINATION OR EXPIRATION OF THIS AGREEMENT.
(D)
EXPENSES. UNLESS OTHERWISE SPECIFICALLY SET
FORTH HEREIN, ALL FEES, COSTS AND EXPENSES INCURRED BY LICENSEE IN DEVELOPING,
MANUFACTURING, PROMOTING, MARKETING AND SELLING LICENSED PRODUCTS OR OTHERWISE
INCURRED UNDER THIS AGREEMENT SHALL BE BORNE SOLELY BY LICENSEE.
3
4.
REGULATORY APPROVAL AND
COMMERCIALIZATION.
(A)
REGULATORY APPROVALS. LICENSEE SHALL BE
RESPONSIBLE, AT ITS EXPENSE, FOR FILING, OBTAINING, AND MAINTAINING ALL
NECESSARY AUTHORIZATIONS FROM THE FDA AND ANY COMPARABLE FOREIGN REGULATORY
AUTHORITIES FOR THE MARKETING AND SALE OF LICENSED PRODUCTS IN THE UNITED STATES
AND SUCH FOREIGN COUNTRIES AS LICENSEE, IN ITS SOLE DISCRETION, DETERMINES.
LICENSEE'S OBLIGATIONS UNDER THIS SECTION 4(B) SHALL INCLUDE THE PREPARATION AND
FILING OF ANY REQUIRED SUBMISSIONS AND THE ESTABLISHMENT AND OVERSIGHT OF ANY
REQUIRED CLINICAL INVESTIGATIONS AND CLINICAL FOLLOW-UP RELATING TO FUTURE
COMMERCIAL SALE OF THE LICENSED PRODUCTS.
(B)
MANUFACTURING AND SALES. UPON RECEIPT OF A
SUBSTANTIALLY EQUIVALENT LETTER FROM THE FDA CLEARING THE LICENSED PRODUCT FOR
MARKETING, LICENSEE SHALL BE RESPONSIBLE FOR MANUFACTURING, MARKETING AND
SELLING SUCH LICENSED PRODUCT AND