þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 04-3072298 | |
(State or other jurisdiction | (I.R.S. Employer | |
of incorporation or organization) | Identification No.) | |
167 Sidney Street | ||
Cambridge, Massachusetts | 02139 | |
(Address of principal executive offices) | (Zip Code) |
Title of Class: | Name of Each Exchange on Which Registered: | |
Common Stock, $.001 par value
|
NASDAQ Global Market | |
(Including Associated Preferred Stock Purchase Rights) |
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o |
Exhibit Index | ||||||||
SIGNATURE | ||||||||
EX-10.55 Amendment dated February 12, 2009 to the License Agreement | ||||||||
EX-31.3 Section 302 Certification of CEO | ||||||||
EX-31.4 Section 302 Certification of CFO |
Incorporated by Reference | ||||||||||
Filed with this | Form or | SEC File | ||||||||
Exhibit Number | Description | Form 10-K/A | Schedule | Filing Date with SEC | Number | |||||
3.1
|
Restated Certificate of Incorporation of Idera Pharmaceuticals, Inc., as amended. | 10-Q | August 1, 2008 | 001-31918 | ||||||
3.2
|
Amended and Restated Bylaws of Idera Pharmaceuticals, Inc. | S-1 | November 6, 1995 | 33-99024 | ||||||
3.3
|
Certificate of Ownership and Merger. | 8-K | September 15, 2005 | 001-31918 | ||||||
4.1
|
Specimen Certificate for shares of Common Stock, $.001 par value, of Idera Pharmaceuticals, Inc. | S-1 | December 8, 1995 | 33-99024 | ||||||
4.2
|
Rights Agreement dated December 10, 2001 by and between Idera Pharmaceuticals, Inc. and Mellon Investor Services LLC, as rights agent. | S-2 | October 10, 2003 | 333-109630 | ||||||
4.3
|
Amendment No. 1 to Rights Agreement dated as of August 27, 2003 between the Company and Mellon Investor Services LLC, as rights agent. | 8-K | August 29, 2003 | 000-27352 | ||||||
4.4
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Amendment No. 2 to Rights Agreement dated as of March 24, 2006 between the Company and Mellon Investor Services LLC, as rights agent. | 8-K | March 29, 2006 | 001-31918 | ||||||
4.5
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Amendment No. 3 to Rights Agreement dated January 16, 2007 between the Company and Mellon Investor Services, LLC, as rights agent. | 8-K | January 17, 2007 | 001-31918 | ||||||
10.1
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2008 Stock Incentive Plan. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.2
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2005 Stock Incentive Plan, as amended | 10-Q | August 14, 2006 | 001-31918 | ||||||
10.3
|
1995 Stock Option Plan. | S-1 | November 6, 1995 | 33-99024 | ||||||
10.4
|
1995 Director Stock Option Plan. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.5
|
1995 Employee Stock Purchase Plan, as amended. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.6
|
Employment Agreement dated October 19, 2005 between Idera Pharmaceuticals, Inc. and Dr. Sudhir Agrawal. | 10-Q | November 9, 2005 | 001-31918 | ||||||
10.7
|
Amendment, dated December 17, 2008 to Employment Agreement by and between the Idera Pharmaceuticals, Inc. and Dr. Sudhir Agrawal dated October 19, 2005. | 8-K | December 18, 2008 | 001-31918 | ||||||
10.8
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Employment Offer Letter dated November 8, 2007 by and between Idera Pharmaceuticals, Inc. and Louis J. Arcudi, III. | 10-K/A | December 24, 2008 | 001-31918 | ||||||
10.9
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Amendment dated December 17, 2008 to Employment Offer Letter by and between Idera Pharmaceuticals, Inc. and Louis J. Arcudi, III, Dated November 8, 2007. | 8-K | December 18, 2008 | 001-31918 | ||||||
10.10
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Non-Employee Director Compensation Program Effective January 1, 2008. | 10-K | March 11, 2008 | 001-31918 | ||||||
10.11
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Amended and Restated 1997 Stock Incentive Plan. | 10-Q | May 15, 2001 | 000-27352 | ||||||
10.12
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Non-Employee Director Nonstatutory Stock Option Agreement Granted under 1997 Stock Incentive Plan. | 10-K | March 25, 2005 | 001-31918 |
Incorporated by Reference | ||||||||||
Filed with this | Form or | SEC File | ||||||||
Exhibit Number | Description | Form 10-K/A | Schedule | Filing Date with SEC | Number | |||||
10.13
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Form of Incentive Stock Option Agreement Granted Under the 2005 Stock Incentive Plan. | 8-K | June 21, 2005 | 001-31918 | ||||||
10.14
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Form of Nonstatutory Stock Option Agreement Granted Under the 2005 Stock Incentive Plan. | 8-K | June 21, 2005 | 001-31918 | ||||||
10.15
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Form of Restricted Stock Agreement Under the 2005 Stock Incentive Plan. | 10-Q | August 1, 2007 | 001-31918 | ||||||
10.16
|
Form of Incentive Stock Option Agreement Granted Under the 2008 Stock Incentive Plan. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.17
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Form of Nonstatutory Stock Option Agreement Granted Under the 2008 Stock Incentive Plan. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.18
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Form of Nonstatutory Stock Option Agreement (Non-Employee Directors) Granted Under the 2008 Stock Incentive Plan. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.19
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Form of Restricted Stock Agreement Under the 2008 Stock Incentive Plan. | 8-K | June 10, 2008 | 001-31918 | ||||||
10.20
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Executive Stock Option Agreement for 1,260,000 Options effective as of July 25, 2001 between Idera Pharmaceuticals, Inc. and Dr. Sudhir Agrawal. | 10-Q | October 24, 2002 | 000-27352 | ||||||
10.21
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Executive Stock Option Agreement for 550,000 Options effective as of July 25, 2001 between Idera Pharmaceuticals, Inc. and Dr. Sudhir Agrawal. | 10-Q | October 24, 2002 | 000-27352 | ||||||
10.22
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Executive Stock Option Agreement for 500,000 Options effective as of July 25, 2001 between Idera Pharmaceuticals, Inc. and Dr. Sudhir Agrawal. | 10-Q | October 24, 2002 | 000-27352 | ||||||
10.23
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License Agreement dated February 21, 1990 and restated as of September 8, 1993 between Idera Pharmaceuticals, Inc. and University of Massachusetts Medical Center. | S-1 | November 6, 1995 | 33-99024 | ||||||
10.24
|
Amendment No. 1 to License Agreement, dated as of February 21, 1990 and restated as of September 8, 1993, by and between University of Massachusetts Medical Center and Idera Pharmaceuticals, Inc., dated as of November 26, 1996. | 10-Q | August 14, 1997 | 000-27352 | ||||||
10.25
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Collaboration and License Agreement by and between Isis Pharmaceuticals, Inc., and Idera Pharmaceuticals, Inc., dated May 24, 2001. | 10-Q | August 20, 2001 | 000-27352 | ||||||
10.26
|
Amendment No. 1 to the Collaboration and License Agreement, dated as of May 24, 2001 by and between Isis Pharmaceuticals, Inc. and Idera Pharmaceuticals, Inc., dated as of August 14, 2002. | 10-K | March 31, 2003 | 000-27352 | ||||||
10.27
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Master Agreement relating to the Cross License of Certain Intellectual Property and Collaboration by and between Isis Pharmaceuticals, Inc. and Idera Pharmaceuticals, Inc., dated May 24, 2001. | 10-Q | August 20, 2001 | 000-27352 | ||||||
10.28
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Unit Purchase Agreement by and among Idera Pharmaceuticals, Inc. and certain persons and entities listed therein, dated April 1, 1998. | 10-K | April 1, 2002 | 000-27352 |
Incorporated by Reference | ||||||||||
Filed with this | Form or | SEC File | ||||||||
Exhibit Number | Description | Form 10-K/A | Schedule | Filing Date with SEC | Number | |||||
10.29
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Registration Rights Agreement, dated as of August 28, 2003 by and among Idera Pharmaceuticals, Inc., the Purchasers and the Agents. | S-2 | October 10, 2003 | 333-109630 | ||||||
10.30
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Form of Common Stock Purchase Warrant issued to purchasers of units in a private placement on August 28, 2003 and August 29, 2003. | S-2 | October 10, 2003 | 333-109630 | ||||||
10.31
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Form of Common Stock Purchase Warrant issued to selected dealers and placement agents on August 28, 2003 in connection with a private placement. | S-2 | October 10, 2003 | 333-109630 | ||||||
10.32
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Registration Rights Agreement, dated August 27, 2004 by and among Idera Pharmaceuticals, Inc., Pillar Investment Limited and Purchasers. | 10-Q | November 12, 2004 | 001-31918 | ||||||
10.33
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Form of Warrants issued to investors and the placement agent in connection with Idera Pharmaceuticals, Inc. August 27, 2004 financing. | 10-Q | November 12, 2004 | 001-31918 | ||||||
10.34
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Research Collaboration and Option Agreement by and between Idera Pharmaceuticals, Inc. and Novartis International Pharmaceutical Ltd. | 10-Q | August 9, 2005 | 001-31918 | ||||||
10.35
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License, Development and Commercialization Agreement by and between Idera Pharmaceuticals, Inc and Novartis International Pharmaceutical Ltd. | 10-Q | August 9, 2005 | 001-31918 | ||||||
10.36
|
Engagement letter, dated May 20, 2005, by and among Idera Pharmaceuticals, Inc. and Pillar Investment Limited. | 10-Q | August 9, 2005 | 001-31918 | ||||||
10.37
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Consulting Agreement dated as of January 1, 2008 between Idera Pharmaceuticals, Inc. and Karr Pharma Consulting, LLC. | 10-K | March 11, 2008 | 001-31918 | ||||||
10.38
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Amendment dated December 16, 2008 to Consulting Agreement dated as of January 1, 2008 between Idera Pharmaceuticals, Inc. and Karr Pharma Consulting, LLC. | 10-K | March 11, 2009 | 001-31918 | ||||||
10.39
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Registration Rights Agreement dated as of May 20, 2005 by and among Idera Pharmaceuticals, Inc., Purchasers and Pillar Investment Limited. | 10-Q | August 9, 2005 | 001-31918 | ||||||
10.40
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Common Stock Purchase Warrant issued to Pillar Investment Limited in connection with the May 20, 2005 Financing. | 10-Q | August 9, 2005 | 001-31918 | ||||||
10.41
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Common Stock Purchase Agreement, dated March 24, 2006, by and among the Company and the Investors named therein. | 8-K | March 29, 2006 | 001-31918 | ||||||
10.42
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Registration Rights Agreement, dated March 24, 2006, by and among the Company and the Investors named therein. | 8-K | March 29, 2006 | 001-31918 | ||||||
10.43
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Amendment No. 1 to the Common Stock Purchase Agreement, dated March 24, 2006, by and among the Company and the Investors named therein. | 10-Q | August 14, 2006 | 001-31918 | ||||||
10.44
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Form of Warrant issued to Investors in the Companys March 24, 2006 Private Financing. | 8-K | March 29, 2006 | 001-31918 | ||||||
10.45
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Common Stock Purchase Agreement, dated March 24, 2006, by and between the Company and Biotech Shares Ltd. | 8-K | March 29, 2006 | 001-31918 |
Incorporated by Reference | ||||||||||
Filed with this | Form or | SEC File | ||||||||
Exhibit Number | Description | Form 10-K/A | Schedule | Filing Date with SEC | Number | |||||
10.46
|
Amendment No. 1 to the Common Stock Purchase Agreement, dated March 24, 2006, by and among the Company and Biotech Shares Ltd. | 10-Q | November 13, 2006 | 001-31918 | ||||||
10.47
|
Engagement Letter, dated March 24, 2006, between the Company and Youssef El Zein. | 8-K | March 29, 2006 | 001-31918 | ||||||
10.48
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Registration Rights Agreement, dated March 24, 2006, by and among the Company, Biotech Shares Ltd. and Youssef El Zein. | 8-K | March 29, 2006 | 001-31918 | ||||||
10.49
|
Warrant issued to Biotech Shares Ltd. on March 24, 2006. | 8-K | March 29, 2006 | 001-31918 | ||||||
10.50
|
Exclusive License and Research Collaboration Agreement by and between Merck & Co., Inc. and Idera Pharmaceuticals, Inc., dated December 8, 2006. | 8-K | March 6, 2007 | 001-31918 | ||||||
10.51
|
Amendment No. 1 to the Registration Rights Agreement dated March 24, 2006, by and among the Company and Biotech Shares Ltd. | 10-Q | August 14, 2006 | 001-31918 | ||||||
10.52
|
Promissory Note dated June 12, 2007 made by Idera Pharmaceuticals, Inc. in favor of General Electric Capital Corporation. | 10-Q | August 1, 2007 | 001-31918 | ||||||
10.53
|
Master Security Agreement dated June 12, 2007 by and between Idera Pharmaceuticals, Inc. and General Electric Capital Corporation. | 10-Q | August 1, 2007 | 001-31918 | ||||||
10.54
|
License Agreement by and between Merck KGaA and Idera Pharmaceuticals, Inc., dated December 18, 2007. | 10-K | March 11, 2008 | 001-31918 | ||||||
10.55
|
Amendment dated February 12, 2009 to the License Agreement by and between Merck KGaA and Idera Pharmaceuticals, Inc., dated December 18, 2007. | X | ||||||||
23.1
|
Consent of Independent Registered Public Accounting Firm. | 10-K | March 11, 2009 | 001-31918 | ||||||
31.1
|
Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | 10-K | March 11, 2009 | 001-31918 | ||||||
31.2
|
Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | 10-K | March 11, 2009 | 001-31918 | ||||||
31.3
|
Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | X | ||||||||
31.4
|
Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14 and 15d-14, as adopted pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | X | ||||||||
32.1
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | 10-K | March 11, 2009 | 001-31918 |
Incorporated by Reference | ||||||||||
Filed with this | Form or | SEC File | ||||||||
Exhibit Number | Description | Form 10-K/A | Schedule | Filing Date with SEC | Number | |||||
32.2
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | 10-K | March 11, 2009 | 001-31918 |
| Confidential treatment granted as to certain portions, which portions are omitted and filed separately with the Commission. | |
| Management contract or compensatory plan or arrangement required to be filed as an Exhibit to the Annual Report on Form 10-K. |
IDERA PHARMACEUTICALS, INC. |
||||
By: | /s/ Sudhir Agrawal | |||
Sudhir Agrawal | ||||
President, Chief Executive Officer and Chief Scientific Officer |
License Agreement Amendment | Page 1 of 10 | Confidential |
(1) | Such trials shall be conducted under Licensors IND Application Number[**] or IND Application Number [**]. | ||
(2) | Licensors 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 Partys 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 Licensors 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 Licensors 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. | ||
(10) | 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 |
License Agreement Amendment | Page 2 of 10 | Confidential |
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. | |||
(11) | Notwithstanding Section 3.4(b)(10), the Parties agree that the Initiation of the [**] Trial shall in no event be considered [**]. | ||
(12) | Licensors 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. | ||
(13) | Mercks 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. | ||
(14) | 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 Mercks 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 | ||
(15) | 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 Mercks 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 |
License Agreement Amendment | Page 3 of 10 | Confidential |
Licensor to Merck at the end of the Interim Period; provided, that Licensor shall have a fully paid, royalty free, non-exclusive license to use and disclose (i) the Clinical Data for purposes of any required regulatory filings in connection with a TLR9 Agonist Trial or to respond to any regulatory inquiries related to the period when Licensor was Sponsor of such Trial and (ii) any safety data that are generated from a TLR9 Agonist Trial for Licensors and its collaborators and their affiliates regulatory purposes. | |||
(16) | Licensor agrees that during such time that Licensor is owner of any Clinical Data, such ownership rights shall be subject to and to the extent applicable, limited by, the terms of this License Agreement, including Section 7.2(c). | ||
(17) | Strategic Development Committee. |
(i) | The Parties shall establish a committee for the purpose of reviewing and exchanging information regarding the general direction and progress of the TLR9 Agonist Trials during the Interim Period (the Strategic Development Committee or SDC). Each Party shall designate two (2) individuals to be its authorized representatives on the Strategic Development Committee (each a SDC Representative). Merck shall also appoint one of the SDC Representatives it has designated as the chair of the Strategic Development Committee (the SDC Chair). The initial SDC Representatives and chairperson are set forth on Schedule 3.4(b). Each Party may change its SDC Representatives, or Merck may change its designee for the SDC Chair, as the case may be, from time to time, effective upon notice to the other Party of such change. Additional representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend SDC meetings. Except as expressly set forth in clauses (ii) and (iii) below, the SDC shall function solely as a forum for reviewing and exchanging information regarding the progress and overall direction of the TLR9 Agonist Trials and not as a decision-making body. The SDC shall meet in accordance with a schedule established by the SDC Chair (taking in consideration the availability of the SDC Representatives), but no less frequently than once a month during the Interim Period and as needed to address an Unresolved Issue as provided under clauses (ii) and (iii) below. Such meetings will occur via teleconference, videoconference or in-person, as determined by the SDC Chair. For an in-person SDC meeting held more than fifty (50) miles outside of Boston, Massachusetts, Merck will reimburse Licensor, in accordance with and subject to its corporate travel and expense policies, for the reasonable travel expenses incurred by Licensors SDC Representatives in connection with their attendance of such meeting outside of Boston. The SDC Chair shall ensure that relevant results of such SDC meetings are recorded and approved by all SDC Representatives. |
License Agreement Amendment | Page 4 of 10 | Confidential |
(ii) | A specific study team comprised of representatives designated by both Licensor and Merck will be formed in respect of each TLR9 Agonist Trial (each a Study Team). With respect to each TLR9 Agonist Trial, the applicable Study Team will be charged with certain decision-making responsibilities related to that Trial as set forth in the Trials Charter Agreement. Each Charter Agreement will set out the procedures pursuant to which an unresolved issue, requiring the unanimous consent of the Study Team members, may be brought before the Strategic Development Committee (each an Unresolved Issue). In the event that the SDC Representatives receive written notice of an Unresolved Issue together with a summary thereof and the action to be decided upon (an Issue Summary), the SDC Representatives shall discuss the Unresolved Issue and shall meet with respect thereto if one or more of them believes a meeting or meetings to be useful. If the SDC Representatives do not resolve the matter within thirty (30) days following receipt by them of the Issue Summary (or such lesser or longer period as they may agree is appropriate for their discussions), then the SDC Chair shall, after due and reasonable consideration and subject to clause (iii) below, make the final decision regarding the Unresolved Issue unless such issue is a Safety Issue as defined below. In that case, Licensors SDC Representatives shall, after due and reasonable consideration, including consultation with the safety team representatives assigned to the relevant Study, make the final decision regarding such Safety Issue. Licensors SDC Representatives shall promptly inform the SDC Chair in writing of any final decisions regarding Safety Issues reached in accordance with this clause (ii). For purposes of this clause (ii), a Safety Issue is (A) any strategy decision regarding a TLR9 Agonist Trial (including a decision to terminate any such Trial) or material change to a TLR9 Agonist Trial protocol that is under consideration which arises from safety findings or other safety matters related to a Compound or (B) any change to a TLR9 Agonist Trial protocol that could reasonably be expected to significantly alter the foreseeable risks or discomforts to a TLR9 Agonist Trial subject. The SDC Chair shall provide the applicable Study Team written notice, with a copy to all other SDC Representatives, of any final decision regarding an Unresolved Issue reached by the Strategic Development Committee pursuant to this clause (ii). |
(iii) | Notwithstanding any of the foregoing, the SDC Chair shall not make a final determination regarding an Unresolved Issue the implementation of which could reasonably be expected to have a material adverse effect on Licensor due to any liabilities or obligations under laws, rules or regulations applicable to Licensor as Sponsor of the relevant TLR9 Agonist Trial (a Sponsor |
License Agreement Amendment | Page 5 of 10 | Confidential |
MAE). For purposes of the foregoing, (A) during the course of Strategic Development Committee discussions regarding an Unresolved Issue, each of the Parties should endeavor to discuss specific proposals to resolve the relevant issue and Licensor shall endeavor in good faith to identify any aspect of a proposal the implementation of which could reasonably be expected to result in a Sponsor MAE and (B) the Merck SDC Representatives shall provide Licensor written notice of any proposed final determination (Proposed Final Determination) to be made hereunder (Final Determination Notice) before its implementation. A Licensors SDC Representative shall notify the Merck SDC Representatives in writing within five (5) Business Days of receipt of a Final Determination Notice if in Licensors reasonable opinion, a Proposed Final Determination could result in a Sponsor MAE. In the absence of any such notice within such five Business Day period, the Proposed Final Determination shall become final and shall be implemented by written notification to the applicable Study Team. In the event a Licensors SDC Representative delivers such notice with respect to a Proposed Final Determination, Merck shall not take any steps to implement the Proposed Final Determination and may submit to Licensor SDC Representatives another Proposed Final Determination that will be subject to this clause (iii). |
License Agreement Amendment | Page 6 of 10 | Confidential |
License Agreement Amendment | Page 7 of 10 | Confidential |
License Agreement Amendment | Page 8 of 10 | Confidential |
Idera Pharmaceuticals, Inc. | ||||
By:
|
/s/ Louis Arcudi, III | |||
Name:
|
Louis Arcudi, III | |||
Title:
|
Chief Financial Officer | |||
Date:
|
11 Feb 2009 | |||
Merck KGaA | ||||
By:
|
/s/ Dr. Claudia [illegible] | |||
Name:
|
Dr. Claudia [illegible] | |||
Title: |
||||
Date:
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13 Feb 2009 | |||
By:
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/s/ Jens Eckhardt | |||
Name:
|
Jens Eckhardt | |||
Title:
|
Legal Counsel | |||
Date:
|
13 Feb 2009 | |||
License Agreement Amendment | Page 9 of 10 | Confidential |
17 December 2007 | CONFIDENTIAL |
1. | I have reviewed this Amendment No. 1 on Form 10-K/A of Idera Pharmaceuticals, Inc.; and | |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report. |
Dated: October 9, 2009 | /s/ Sudhir Agrawal | |||
Sudhir Agrawal | ||||
Chief Executive Officer | ||||
1. | I have reviewed this Amendment No. 1 on Form 10-K/A of Idera Pharmaceuticals, Inc.; and | |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report. |
Date: October 9, 2009 | /s/ Louis J. Arcudi, III | |||
Louis J. Arcudi, III | ||||
Chief Financial Officer | ||||