Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
Amendment
To The License Agreement
This Amendment,
effective the 12th day of February, 2009, (“ Amendment
Date ”) is by and between Idera Pharmaceuticals, Inc.,
having a place of business located at 167 Sidney Street, Cambridge,
Massachusetts 02139 (“ Idera ”) and Merck KGaA,
a general partnership limited by shares organized under German law
having a place of business at Frankfurter Strasse 250, 64293
Darmstadt, Germany (“ Merck ”). Idera and Merck
may be referred to collectively as
“Parties.”
The Parties
entered into a License Agreement dated 18 December 2007
(“ License Agreement ”), which sets forth
certain terms and conditions for the Parties to research, develop
and commercialize immune modulatory oligonucleotides in the field
of cancer.
The Parties now
desire to amend the License Agreement to allow Idera to continue to
act as the sponsor (as such term is defined in 21 CFR §
312.3(b), hereinafter “ Sponsor ”) of certain
clinical trials until such time as Merck has filed an
Investigational New Drug application with the US Food and Drug
Administration and assumes the Sponsor role under the Merck
IND.
Now, Therefore
, the Parties hereby agree as
follows:
1.
Section 1.17, definition of “Development Costs” is
hereby amended and restated in its entirety as follows:
“
Development Costs ” means those Out-of-Pocket Expenses
incurred by Licensor after the Effective Date that are directly and
solely attributable to the achievement of work or activities
performed by or on behalf of Licensor after the Effective Date
toward the completion of the On-Going Trials or the Future
Trials.
2.
Section 3.4, of the License Agreement, Licensor Support in the
Development, is hereby amended and restated in its entirety as
follows:
3.4(a).
Licensor Support in the Development. For a period of [**]
starting from Effective Date, Licensor shall make its employees
that are knowledgeable on the Compound or Follow-On Compound, its
properties and functions, reasonably available to Merck, at
Licensor’s facilities, for scientific and technical
explanations, advice and support, that may reasonably be required
by Merck, relating to the Development and registration of the
Compound, Follow-On Compound and the Licensed Products (the
“Development Support” ). The Development Support
shall be provided by Licensor [**] during such first [**] following
the Effective Date. Thereafter, during the remaining [**] period,
Merck shall reimburse Licensor for Licensor’s reasonable
Out-of-Pocket Expenses incurred in providing the Development
Support should Merck require any of such Development Support,
subject however to Licensor providing Merck with documented
evidence of such Out-of-Pocket Expenses having been
incurred.
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License
Agreement Amendment
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Page 1 of 10
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Confidential
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3.4(b).
Licensor Sponsorship and Conduct of Clinical Trials.
Notwithstanding Section 2.3 and 3.4(a), during the Interim
Period Licensor agrees to remain the Sponsor for the On-Going
Trials and for additional Clinical Trials that the Parties agree to
conduct during the Interim Period, including the study in [**]
(“ Future Trials ” and together with the
On-Going Trials, collectively, the “TLR9 Agonist
Trials”). For purposes of this Agreement, the “Interim
Period” means that period of time commencing on the Effective
Date and ending on the date that is the earlier of (i) the
date on which the FDA has approved the IND submitted by Merck for
conducting clinical trials with Licensor’s TLR9 agonists (the
“ Merck TLR9 Agonists IND ”) and Merck has
assumed the role of Sponsor for all on-going TLR9 Agonist Trials or
(b) the date that is twenty-four (24) months from the
Effective Date. The following provisions shall apply during the
Interim Period in connection with the conduct of the TLR9 Agonist
Trials:
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(1)
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Such trials shall be conducted under
Licensor’s IND Application Number[**] or IND Application
Number [**].
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(2)
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Licensor’s acts shall be in
compliance with Section 3.2.
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(3)
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The
Parties shall establish an agreement for each TLR9 Agonist Trial
that sets forth each Party’s responsibilities (the “
Charter Agreements ”).
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(4)
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The
Charter Agreements shall, at a minimum, identify a process for
developing and executing the protocol for each TLR9 Agonist Trial
and set forth a trial budget to be paid by Merck, which shall
include after [**] the reimbursement by Merck of Licensor’s
internal costs, up to an agreed upon limit and at an agreed upon
rate to be set forth in the budget attached to the respective
Charter Agreement and pre-approved Development Costs in conducting
such trial (each a “ Trial Budget ”).
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(5)
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Merck shall have responsibility for
determining if any Future Trial is to be conducted and for defining
objectives of any Future Trial.
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(6)
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Merck shall seek Licensor’s
input on each Future Trial.
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(7)
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If
requested by Merck during the Interim Period, Licensor agrees to
initiate and conduct the [**] Trial during the Interim Period,
subject to the terms of a mutually agreed Charter Agreement, unless
Licensor, in its reasonable discretion, determines that it is
unable to conduct such trial, wherein such determination takes into
account [**] under the relevant Charter Agreement.
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(8)
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For
each Future Trial [**] that Merck desires to initiate during the
Interim Period, Licensor agrees to initiate and conduct such Future
Trial during the Interim Period, subject to the terms of a mutually
agreed Charter Agreement, unless Licensor, in its sole discretion,
determines that it is unable to conduct such trial. Such inability
determination shall take into [**] under the relevant Charter
Agreement.
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(9)
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Licensor shall have the right to
take, at its sole discretion after appropriate discussions with
Merck under the Charter Agreements, any actions it reasonably deems
necessary or desirable to fulfill the regulatory requirements
appropriate to the role of Sponsor for any or all TLR9 Agonist
Trials.
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