OF THIS AGREEMENT, (I)
BIOGEN IDEC SHALL PROVIDE IMMUNOGEN WITH WRITTEN NOTICE WHICH SHALL IDENTIFY
SUCH MATERIAL OBLIGATION(S) AND (II) SOLELY TO THE EXTENT IMMUNOGEN FAILS TO
REMEDY SUCH FAILURE ON OR BEFORE [***] ([***]) DAYS OF RECEIPT OF SUCH NOTICE,
BIOGEN IDEC MAY, IN ADDITION TO OTHER REMEDIES AVAILABLE TO IT UNDER THIS
AGREEMENT AT LAW AND IN EQUITY, ASSUME SUCH OBLIGATIONS WHICH IMMUNOGEN HAS
FAILED TO CARRY OUT UNDER SUCH SECTIONS OR ASSIGN THEM TO A THIRD PARTY.
CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential investment under Rule 24b-2 under the Securities Exchange Act of
1934.
20
IMMUNOGEN AGREES TO REASONABLY COOPERATE WITH BIOGEN IDEC IN THE TRANSITION OF
ITS ACTIVITIES UNDER THIS SECTION 3.1(E) TO BIOGEN IDEC OR A THIRD PARTY AS
CONTEMPLATED BY THE PRECEDING SENTENCE, SUCH COOPERATION TO INCLUDE WITHOUT
LIMITATION USING COMMERCIALLY REASONABLE EFFORTS TO [**************************]
OF [********] TO PERMIT BIOGEN IDEC OR A THIRD PARTY TO CARRY OUT THE ACTIVITIES
TRANSITIONED UNDER THIS SECTION 3.1(E).
UPON COMPLETION OF THE TRANSITION OF
ACTIVITIES SET FORTH ABOVE, THE PARTIES SHALL NEGOTIATE IN GOOD FAITH AN
[****************] TO ANY PROVISIONS RELATED TO [***] AND [***] FROM BIOGEN IDEC
TO IMMUNOGEN UNDER THIS AGREEMENT TO [***] FOR THE [***] OF SUCH SERVICES.
3.2
DEVELOPMENT AND COMMERCIALIZATION.
(A)
RESPONSIBILITY.
SUBJECT TO SECTION 3.3 OF
THIS AGREEMENT, ON AND AFTER THE EFFECTIVE DATE, BIOGEN IDEC SHALL HAVE SOLE
CONTROL AND AUTHORITY OVER THE DEVELOPMENT AND COMMERCIALIZATION OF LICENSED
PRODUCTS IN THE FIELD IN THE TERRITORY, INCLUDING, WITHOUT LIMITATION, (I)
RESEARCH AND ALL PRE-CLINICAL DEVELOPMENT ACTIVITIES (INCLUDING THE ASSESSMENT
OF ALTERNATIVE DESIGNS FOR THE [***]-MAY CONJUGATE, THE SELECTION OF THE FINAL
[***] ANTIBODY AND MAY COMPOUND TO BE USED IN THE [***]-MAY CONJUGATE AND THE
SELECTION OF THE [***]-MAY CONJUGATE TO BE DEVELOPED AS A LICENSED PRODUCT, ALL
PRECLINICAL AND IND-ENABLING STUDIES, INCLUDING TOXICOLOGY TESTING, ANY
PHARMACEUTICAL DEVELOPMENT WORK ON FORMULATIONS OR PROCESS DEVELOPMENT RELATING
TO ANY SUCH LICENSED PRODUCT), (II) ALL ACTIVITIES RELATED TO HUMAN CLINICAL
TRIALS (INCLUDING ANY PHASE II CLINICAL TRIALS AND/OR PIVOTAL TRIALS), (III)
SUBJECT TO SECTION 4 OF THIS AGREEMENT, ALL ACTIVITIES RELATING TO MANUFACTURE
AND SUPPLY OF ALL [***] ANTIBODIES, ALL MAY COMPOUNDS, ALL [***]-MAY CONJUGATES
AND ALL LICENSED PRODUCTS, TO THE EXTENT SUCH ACTIVITIES RELATE TO THE
DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS (INCLUDING ALL REQUIRED
PROCESS DEVELOPMENT AND SCALE UP WORK WITH RESPECT THERETO), (IV) ALL
COMMERCIALIZATION, ACTIVITIES RELATING TO ANY LICENSED PRODUCT, AND (V) ALL
ACTIVITIES RELATING TO ANY REGULATORY FILINGS, REGISTRATIONS, APPLICATIONS AND
REGULATORY APPROVALS RELATING TO ANY OF THE FOREGOING (INCLUDING ANY INDS OR
FOREIGN EQUIVALENTS, ANY MANUFACTURING FACILITY VALIDATION AND/OR LICENSURE, ANY
DRUG APPROVAL APPLICATIONS AND ANY
CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential investment under Rule 24b-2 under the Securities Exchange Act of
1934.
21
OTHER REGULATORY APPROVALS).
BIOGEN