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Exhibit 10.55

Execution Version

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.”

Background

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.

 

 

 

 

 

License Agreement Amendment

 

Page 1 of 10

 

Confidential

 


 

Execution Version

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:

 

(1)

 

Such trials shall be conducted under Licensor’s IND Application Number[**] or IND Application Number [**].

 

 

(2)

 

Licensor’s acts shall be in compliance with Section 3.2.

 

 

(3)

 

The Parties shall establish an agreement for each TLR9 Agonist Trial that sets forth each Party’s responsibilities (the “ Charter Agreements ”).

 

 

(4)

 

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 ”).

 

 

(5)

 

Merck shall have responsibility for determining if any Future Trial is to be conducted and for defining objectives of any Future Trial.

 

 

(6)

 

Merck shall seek Licensor’s input on each Future Trial.

 

 

(7)

 

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.

 

 

(8)

 

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.

 

 

(9)

 

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.