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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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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(10)
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For
the avoidance of doubt, if the Initiation of a Future Trial by
Idera would qualify as a milestone payment triggering event as set
forth in Section 5.2 if
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such Initiation had been undertaken
by Merck, such milestone shall be considered achieved as if Merck
achieved such milestone and all payments resulting therefrom shall
be due and payable by Merck to Idera according to the
Agreement.
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(11)
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Notwithstanding
Section 3.4(b)(10), the Parties agree that the Initiation of
the [**] Trial shall in no event be considered [**].
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(12)
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Licensor’s acts pursuant to
the provisions of this Section 3.4(b) shall not be considered a
breach of Section 2.6 or Section 3.1.
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(13)
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Merck’s acts pursuant to the
provisions of this Section 3.4(b), as well as the fact that
Merck [**], shall not be considered a breach of Section 3.2 or
Section 3.9.
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(14)
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Licensor has entered into a contract
with [**] pursuant to which [**] is to perform certain labeling,
storage, packing and distribution activities related to [**] on
behalf of Licensor. During the Interim Period and in accordance
with Merck’s direction, Licensor shall manage the labeling,
packing and distribution of [**] vials of [**] via [**] for
purposes of (i) completion of transfer of the manufacturing
technology as provided for under this License Agreement,
(ii) the On-Going Trials and (iii) any Future Trials.
Licensor shall not be responsible for manufacturing any amounts of
[**] in addition to the [**] vials referenced in this clause (14).
To the extent that Licensor follows the direction given by Merck
pursuant to this clause (14), Merck shall be accountable for the
allocation of such vials to the transfer of the manufacturing
technology activities, the On-Going Trials and any Future
Trials
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(15)
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With respect to each TLR9 Agonist
Trial, Licensor shall own the corresponding clinical data generated
by that Trial (the “Clinical Data”) until such time as
Merck shall [**]. Merck shall have a fully paid, royalty free,
exclusive license to use, disclose and copy the Clinical Data
related to such Trial to bring about the purposes of this License
Agreement, the Charter Agreements and the filing of the Merck TLR9
Agonists IND. Licensor shall retain the right to use, disclose and
copy (i) any and all Clinical Data during the Interim Period
as necessary to comply with applicable laws, rules and regulations
and to publish in accordance with Section 7.2 of the License
Agreement, (ii) any safety data in connection with contractual
pharmacovigilance obligations to third parties and (iii) the
final study report for [**] to the extent necessary to comply with
[**]. In connection with the foregoing and to the fullest extent
permitted by law, Licensor shall authorize any contract research
organization, data management company or central laboratory
providing services in respect of a TLR9 Agonist Trial to
concurrently disclose the related Clinical Data to Merck or
Merck’s designee. In respect of Clinical Data for a TLR9
Agonist Trial generated by a Third-Party vendor other than a
contracts research organization, data management company or central
laboratory, Licensor shall promptly and timely disclose Clinical
Data to Merck after receipt thereof from such Third-Party vendor.
Without additional action or payment of an additional fee,
ownership of the Clinical Data will transfer from
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