Dr. Georges Gemayel, President
Altus Pharmaceuticals Inc.
333 Wyman Street
Waltham, MA 02451
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Re:
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Mutual
Termination of the February 22, 2001 Agreement and Transition
of Trizytek
Development and Commercialization
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The purpose of
this letter is to confirm the substance of our discussions
regarding the terms pursuant to which CFFT will assume
responsibility for the further development and commercialization of
Trizytek. The relationship between CFFT and Altus regarding
Trizytek is currently governed by the terms of the Strategic
Alliance Agreement dated February 22, 2001, as amended by the
First and Second Amendments (collectively, the February 22,
2001 Agreement and subsequent amendments shall be referred to
hereinafter as the “Alliance Agreement”, and Altus and
CFFT shall be referred to hereinafter collectively as the
“Parties”). Based on Altus’ desire to cease
development of Trizytek in connection with its current corporate
realignment efforts, the Parties now wish to terminate the Alliance
Agreement in its entirety and replace it with this Letter Agreement
(the “Letter Agreement”) and the License Agreement (the
“License Agreement,” a copy of which is attached as
Exhibit A) in order to provide CFFT with the intellectual
property rights and technology transfer support necessary for CFFT
to assume development and commercialization activities for
Trizytek. This Letter Agreement shall constitute a binding
agreement between the Parties, subject to the Parties entering into
the License Agreement simultaneously herewith. Capitalized terms
used but not otherwise defined herein shall have the meanings
ascribed to them in the Alliance Agreement.
This Letter
Agreement shall be effective as of the date first set forth above
(the “Effective Date”). The Alliance Agreement shall
terminate as of the effective date of the License Agreement, which
shall be the same date as the Effective Date.
CFFT shall take
such steps after the Effective Date as it considers appropriate and
are consistent with this Letter Agreement and CFFT’s
charitable purposes to attempt to arrange for Trizytek to be
available to cystic fibrosis patients. In furtherance of the above,
the Parties hereby agree as follows:
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1.
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Transition Plan; Transfer of
Materials; Payment of Trizytek Obligations . The Parties have agreed on a
written transition plan, consistent with the terms of this Letter
Agreement, covering the activities to be performed by Altus and, as
applicable, CFFT between the Effective Date and March 27, 2009
(the “Transition Plan”). Altus shall use commercially
reasonable efforts to perform all of its obligations under the
Transition Plan, subject to the continued availability of existing
personnel. Altus has also provided
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Portions of this Exhibit are
omitted and have been filed separately with the Secretary of
the
Commission pursuant to the Registrant’s application
requesting confidential treatment under Rule
24b-2 of the Exchange Act
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to
CFFT a written project plan (the “Project Plan”)
covering the actions Altus expects will be required to be taken by
CFFT or its sublicensee in order to file an NDA for Trizytek (all
of which shall be the responsibility of CFFT or its sublicensee
rather than Altus). The Transition Plan is incorporated herein as
Exhibit B to this Letter Agreement. Altus hereby warrants and
represents that it has paid, will pay or will adequately reserve
for prior to March 28, 2009, all obligations relating to
Trizytek accruing prior to March 28, 2009.
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2.
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Technology Transfer; Transfer of
[*]; Third Party Contractors . Altus will use commercially
reasonable efforts to transfer the know-how and technology covered
by the Intellectual Property and Improvements to CFFT or its
sublicensee prior to March 27, 2009 (ownership of and rights
in such know-how and technology to be as provided in the License
Agreement), and to cooperate with CFFT and its sublicensee
thereafter relating to this Letter Agreement. Further, Altus will
transfer or arrange for the transfer of ownership of [*]. Altus
will also use commercially reasonable efforts to arrange for direct
discussions between CFFT and Altus’ third party contractors,
including [*].
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3.
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Completion of Ongoing Clinical
Trial . Altus
will bear the costs associated with continuing the ongoing #767
clinical trial to the extent that such costs accrue on or prior to
March 27, 2009. CFFT will bear all costs associated with the
#767 clinical trial that accrue on or after March 28, 2009.
Altus will remain party to the existing #767 clinical trial
agreements and, subject to CFFT’s instructions, continue to
supervise and perform Altus’ obligations thereunder until
March 27, 2009. Altus will use commercially reasonable efforts
to assign each of the existing #767 clinical trial agreements to
CFFT or its sublicensee, with such assignments becoming effective
March 28, 2009 unless CFFT determines it is impracticable to
do so. With respect to existing #767 clinical trial agreements that
Altus is unable to assign to CFFT or its sublicensee (collectively,
the “Non-Assignable Trial Agreements”), Altus will,
during the period beginning on March 28, 2009 and continuing
until completion of the on-going #767 clinical trial, supervise and
perform its obligations under the Non-Assignable Trial Agreements
through one or more independent contractors selected by mutual
agreement of the Parties (or by CFFT if the Parties cannot agree).
During this period, CFFT will make any payments due under the
Non-Assignable Trial Agreements either directly or through Altus,
as mutually agreed by the Parties, and will provide advance funding
for the cost to Altus of such third party contractors. CFFT hereby
indemnifies Altus [*]. Altus will make appropriate arrangements
with [*] (and all other relevant third party contractors’)
personnel to facilitate direct discussions with CFFT’s
employees or independent contractors, as applicable, relating to
the [*].
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4.
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Wind-Up of Other Clinical
Trials .
Altus will, at its expense, complete and deliver to CFFT a final
study report for the #726 clinical trial on or prior to
March 27, 2009. Altus will, at its expense, use commercially
reasonable efforts to continue to perform ongoing close out
activities in the normal course of business with respect to the
#810 clinical trial until March 27, 2009 and furnish CFFT with
all existing documents relating to such clinical trial.
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Portions of this Exhibit are
omitted and have been filed separately with the Secretary of
the
Commission pursuant to the Registrant’s application
reque
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