OF ANY MATERIAL
MEETING WITH THE FDA WHICH IS FOR THE PURPOSE OF OBTAINING REGULATORY APPROVAL
FOR ANY LICENSED PRODUCT AND BIOGEN IDEC SHALL PROVIDE TO IMMUNOGEN THE MINUTES
OF ANY SUCH MEETING COMMUNICATED TO OR FROM THE REGULATORY AUTHORITY WITHIN
[***] ([***]) DAYS FROM THE DATE ON WHICH THE MEETING MINUTES WERE SUBMITTED TO,
OR RECEIVED FROM SUCH REGULATORY AGENCY.
(E)
CONFIDENTIAL INFORMATION.
ALL
INFORMATION, REPORTS, UPDATES, ADVERSE DRUG EXPERIENCE, 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,
EXCEPTIONS AND PERMITTED DISCLOSURES 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 BIOGEN IDEC IN THE EXERCISE OF ITS RIGHTS TO MAKE
OR HAVE MADE LICENSED PRODUCTS
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.
24
UNDER THIS AGREEMENT.
THE COLLABORATION COMMITTEE SHALL SOLELY SERVE AS A FORUM
FOR COORDINATION AND COMMUNICATION AND SHALL NOT HAVE ANY AUTHORITY TO MAKE
DECISIONS.
WITHIN A REASONABLE PERIOD OF TIME AFTER THE EFFECTIVE DATE, THE
PARTIES SHALL EACH NOMINATE REPRESENTATIVES (WHICH SHALL BE NO LESS THAN TWO (2)
AND NO MORE THAN FIVE (5) EACH) FOR MEMBERSHIP ON THE COLLABORATION COMMITTEE.
EACH REPRESENTATIVE SHALL BE AN INDIVIDUAL OF SUITABLE AUTHORITY AND SENIORITY
WHO HAS SUFFICIENT EXPERIENCE IN BIOPHARMACEUTICAL DRUG RESEARCH, DEVELOPMENT,
MANUFACTURING OR COMMERCIALIZATION.
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 BIOGEN IDEC REPRESENTATIVES ON
THE COLLABORATION COMMITTEE, AS DESIGNATED BY BIOGEN IDEC.
THE COLLABORATION
COMMITTEE SHALL MEET ON A SEMI-ANNUAL BASIS OR OTHER SCHEDULE AGREED UPON BY THE
PARTIES, UNLESS AT LEAST THIRTY (30) DAYS IN ADVANCE OF ANY MEETING THE CHAIR OF
THE COLLABORATION COMMITTEE DETERMINES THAT THERE IS NO NEED FOR A MEETING.
IN
SUCH INSTANCE, THE NEXT COLLABORATION COMMITTEE MEETING SHALL ALSO BE SCHEDULED
AS AGREED UPON BY THE PARTIES.
THE LOCATION OF MEETINGS OF THE COLLABORATION
COMMITTEE SHALL ALTERNATE BETWEEN IMMUNOGEN'S OFFICES IN THE UNITED STATES AND
BIOGEN IDEC'S OFFICES IN THE UNITED STATES, UNLESS OTHERWISE AGREED BY THE
PARTIES. AS AGREED UPON BY THE PARTIES, COLLABORATION COMMITTEE MEETINGS MAY BE
FACE-TO-FACE OR MAY BE CONDUCTED THROUGH TELECONFERENCES AND/OR
VIDEOCONFERENCES.
IN ADDITION TO ITS COLLABORATION COMMITTEE REPRESENTATIVES,
EACH PARTY SHALL BE ENTITLED TO HAVE OTHER EMPLOYEES