REGULATIONS IN ACCORDANCE WITH PROCEDURES THAT SHALL BE AGREED TO BY THE PARTIES
BASED, IN GENERAL, ON SCHEDULE D ATTACHED HERETO (IT BEING THE UNDERSTANDING OF
THE PARTIES THAT SUCH SCHEDULE D IS INCLUDED AS AN EXAMPLE ONLY AND SHALL NOT BE
BINDING UPON THE PARTIES).
CENTOCOR SHALL PROVIDE ITS ADVERSE EVENT AND PRODUCT
COMPLAINT INFORMATION HEREUNDER TO IMMUNOGEN'S DESIGNATED REPRESENTATIVE, WHO
SHALL BE ITS CHIEF REGULATORY OFFICER UNLESS IMMUNOGEN OTHERWISE NOTIFIES
CENTOCOR.
IMMUNOGEN SHALL PROVIDE ITS ADVERSE EVENT AND PRODUCT COMPLAINT
INFORMATION HEREUNDER TO CENTOCOR'S DESIGNATED REPRESENTATIVE IDENTIFIED ON
SCHEDULE D UNLESS CENTOCOR OTHERWISE NOTIFIES IMMUNOGEN.
(D)
CORRESPONDENCE FOR LICENSED PRODUCTS.
TO
THE EXTENT REASONABLY PRACTICABLE AND SUBJECT TO ANY THIRD PARTY CONFIDENTIALITY
OBLIGATIONS, CENTOCOR SHALL PROVIDE IMMUNOGEN WITH COPIES OF ANY MATERIAL
DOCUMENTS OR CORRESPONDENCE PERTAINING TO IMMUNOGEN'S MANUFACTURE OF PRECLINICAL
MATERIALS, CLINICAL MATERIALS OR ANY LICENSED PRODUCT AND PREPARED FOR
SUBMISSION TO THE FDA AND ANY MATERIAL DOCUMENTS OR OTHER CORRESPONDENCE
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 Ace of
1934.
21
RECEIVED FROM THE FDA PERTAINING TO IMMUNOGEN'S MANUFACTURE OF PRECLINICAL
MATERIALS, CLINICAL MATERIALS OR ANY LICENSED PRODUCT.
IMMUNOGEN SHALL COMPLETE
ITS REVIEW WITHIN [********] DAYS AFTER RECEIPT OF THE PROPOSED SUBMISSION. WHEN
REQUESTED IN WRITING, IMMUNOGEN SHALL PROVIDE REASONABLE ASSISTANCE TO CENTOCOR
IN OBTAINING REGULATORY APPROVALS FOR LICENSED PRODUCT.
NOTWITHSTANDING THE
FOREGOING, CENTOCOR SHALL HAVE THE SOLE RESPONSIBILITY FOR, AND IMMUNOGEN AGREES
THAT CENTOCOR SHALL BE THE SOLE OWNER OF, ANY REGULATORY APPROVAL FOR THE
LICENSED PRODUCT.
(E)
CONFIDENTIAL INFORMATION.
ALL REPORTS,
UPDATES, ADVERSE EVENT, PRODUCT COMPLAINT AND OTHER INFORMATION PROVIDED BY THE
DISCLOSING PARTY TO THE RECEIVING PARTY UNDER THIS AGREEMENT (INCLUDING UNDER
THIS SECTION 3.3), SHALL BE CONSIDERED CONFIDENTIAL INFORMATION OF THE
DISCLOSING PARTY, SUBJECT TO THE TERMS OF SECTION 6.
3.4
COLLABORATION COMMITTEE.
(A)
MANDATE AND ESTABLISHMENT OF COMMITTEE.
PROMPTLY AFTER THE EFFECTIVE DATE, THE PARTIES SHALL FORM A COLLABORATION
COMMITTEE TO SERVE AS A FORUM FOR COORDINATION AND COMMUNICATION BETWEEN THE
PARTIES WITH RESPECT TO THE RESEARCH PROGRAM AND/OR THE DEVELOPMENT OF
MANUFACTURING PROCESSES APPLICABLE TO ANY MAY COMPOUND OR LICENSED PRODUCT
COVERED BY THIS AGREEMENT (INCLUDING, WITHOUT LIMITATION, ALL PROCESS SCIENCE
AND PROCESS DEVELOPMENT WORK, FORMULATION WORK, AND QUALITY CONTROL/ASSURANCE
WORK HEREUNDER), AND TO ASSIST CENTOCOR IN ITS EXERCISE OF ITS RIGHTS TO MAKE OR
HAVE MADE LICENSED PRODUCTS UNDER THIS AGREEMENT.
WITHIN THIRTY (30) DAYS AFTER
THE EFFECTIVE DATE, THE PARTIES SHALL EACH NOMINATE AN EQUAL NUMBER OF
REPRESENTATIVES (WHICH SHALL BE NO LESS THAN TWO (2) EACH) FOR MEMBERSHIP ON THE
COLLABORATION COMMITTEE.
EACH PARTY MAY CHANGE ITS REPRESENTATIVE(S) AS IT
DEEMS APPROPRIATE BY NOTICE TO THE OTHER PARTY.
(B)
CHAIR OF COMMITTEE; MEETINGS.
THE CHAIR OF
THE COLLABORATION COMMITTEE SHALL BE ONE OF THE CENTOCOR REPRESENTATIVES ON THE
COLLABORATION COMMITTEE, AS DESIGNATED BY CENTOCOR.
THE COLLABORATION COMMITTEE
SHALL MEET ON A SEMI-ANNUAL BASIS OR OTHER SCHEDULE AGREED UPON BY THE PARTIES,