7. Procés experimental
7.1. Descripció del mètode experimental
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Michael R. Bristow and Patrick M. Wheeler, and each of them, as his true and lawful attorneys-in-fact and agents, with full power of substitution for him, and in his name in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of ARCA biopharma, Inc., in the capacities and on the dates indicated.
Signature Title Date
/s/ MICHAEL R. BRISTOW
Michael R. Bristow
President and Chief Executive Officer and Director (Principal Executive Officer) March 8, 2011 /s/ PATRICK M. WHEELER
Patrick M. Wheeler
Chief Financial Officer (Principal Financial Officer) March 8, 2011 /s/ RICHARD B. BREWER
Richard B. Brewer
Director March 8, 2011
/s/ JEAN-FRANCOIS FORMELA
Jean-Francois Formela Director March 8, 2011 /s/ LINDA GRAIS Linda Grais Director March 8, 2011 /s/ TED W. LOVE Ted W. Love Director March 8, 2011 /s/ MARY K. PENDERGAST Mary K. Pendergast Director March 8, 2011 92
Table of Contents
Signature Title Date
/s/ BURTON E. SOBEL Burton E. Sobel Director March 8, 2011 /s/ JOHN L. ZABRISKIE John L. Zabriskie Director March 8, 2011 93
Table of Contents EXHIBIT INDEX Exhibit Number Description 2.1
Agreement and Plan of Merger and Reorganization, dated September 24, 2008, among Nuvelo, Inc., Dawn Acquisition Sub, Inc. and ARCA biopharma, Inc.(5)
2.2
Amendment No. 1 to Agreement and Plan of Merger and Reorganization, dated October 28, 2008, by and among Nuvelo, Inc., Dawn Acquisition Sub, Inc. and ARCA biopharma, Inc.(6)
3.1 Amended and Restated Certificate of Incorporation of the Registrant, as amended.(8) 3.2 Second Amended and Restated Bylaws of the Registrant, as amended.(10)
4.1 Form of Common Stock Certificate.(7)
4.2 Certificate of Designations of Series A Junior Participating Preferred Stock. (included as part of Exhibit 3.1)
4.3 Warrant to Purchase Stock Agreement, dated July 17, 2007, by and between ARCA Discovery, Inc. and Silicon Valley Bank.(8) 4.4
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and SVB Financial Group.(8)
4.5 Warrant to Purchase Stock Agreement, dated August 19, 2008, by and between ARCA biopharma, Inc. and Silicon Valley Bank.(8) 4.6
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and SVB Financial Group.(8)
4.7 Warrant to Purchase Stock Agreement, dated October 10, 2008, by and between ARCA biopharma, Inc. and Boulder Ventures IV, L.P.(8) 4.8
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and Boulder Ventures IV, L.P.(8)
4.9
Warrant to Purchase Stock Agreement, dated October 10, 2008, by and between ARCA biopharma, Inc. and Boulder Ventures IV (Annex), L.P.(8)
4.10
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and Boulder Ventures IV (Annex), L.P.(8)
4.11 Warrant to Purchase Stock Agreement, dated October 10, 2008, by and between ARCA biopharma, Inc. and InterWest Partners IX, LP.(8) 4.12
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and InterWest Partners IX, LP.(8)
4.13 Warrant to Purchase Stock Agreement, dated October 10, 2008, by and between ARCA biopharma, Inc. and Atlas Venture Fund VII, L.P.(8) 4.14
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and Atlas Venture Fund VII, L.P.(8)
4.15 Warrant to Purchase Stock Agreement, dated October 10, 2008, by and between ARCA biopharma, Inc. and The Peierls Foundation, Inc.(8) 4.16
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and The Peierls Foundation, Inc.(8)
4.17
Warrant to Purchase Stock Agreement, dated October 10, 2008, by and between ARCA biopharma, Inc. and Skyline Venture Partners Qualified Purchaser Fund IV, L.P.(8)
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Exhibit
Number Description
4.18
Amendment No. 1 to Warrant to Purchase Stock Agreement, dated February 19, 2009, by and between ARCA biopharma, Inc. and Skyline Venture Partners Qualified Purchaser Fund IV, L.P.(8)
4.19 Warrant to Purchase Stock Agreement, dated October 18, 2009, by and between ARCA biopharma, Inc. and BioMed Realty, L.P.(17) 10.1§ Amended and Restated Collaboration and License Agreement, dated July 31, 2006, by and between Nuvelo, Inc. and Archemix Corp.(2) 10.2§
Second Amended and Restated Collaboration and License Agreement, dated April 20, 2010, by and between ARCA biopharma, Inc. and Archemix Corp.(18)
10.3 Lease, dated February 8, 2008, by and between ARCA Discovery, Inc. and Arista Place, LLC.(8)
10.4 Loan and Security Agreement, dated July 17, 2007, by and between ARCA Discovery, Inc. and Silicon Valley Bank.(8)
10.5 First Amendment to Loan and Security Agreement, dated January 21, 2009, by and between ARCA biopharma, Inc. and Silicon Valley Bank.(8) 10.6
Second Amendment to Loan and Security Agreement, dated March 23, 2009, by and between ARCA biopharma Colorado, Inc. and Silicon Valley Bank.(8)
10.7
Third Amendment to Loan and Security Agreement, dated April 6, 2009, by and between ARCA biopharma Colorado, Inc. and Silicon Valley Bank(15)
10.8
Fourth Amendment to Assumption of Loan and Security Agreement, dated April 10, 2009, by and between ARCA biopharma, Inc., ARCA biopharma Colorado, Inc. and Silicon Valley Bank(15)
10.9§ License and Sublicense Agreement, dated October 28, 2003, by and between ARCA Discovery, Inc. and CPEC, L.L.C.(13)
10.10§ Amendment to License and Sublicense Agreement, dated February 22, 2006, by and between ARCA Discovery, Inc. and CPEC L.L.C.(14) 10.11§
Exclusive License Agreement, dated October 14, 2005, by and between ARCA Discovery, Inc. and the University of Colorado's License Equity Holdings, Inc.(13)
10.12§
First Amendment to Exclusive License Agreement, dated June 23, 2006, by and between ARCA Discovery, Inc. and the University of Colorado's License Equity Holdings, Inc.(13)
10.13§
Second Amendment to Exclusive License Agreement, dated July 20, 2006, by and between ARCA Discovery, Inc. and the University of Colorado's License Equity Holdings, Inc.(13)
10.14
Third Amendment to Exclusive License Agreement, dated July 19, 2007, by and between ARCA Discovery, Inc. and the University of Colorado's License Equity Holdings, Inc.(13)
10.15§
Fourth Amendment to Exclusive License Agreement, dated August 22, 2007, by and between ARCA Discovery, Inc. and the University of Colorado's License Equity Holdings, Inc.(13)
10.16§ Diagnostic, Collaboration and Option Agreement, dated June 23, 2006, by and between ARCA Discovery, Inc. and CardioDX, Inc.(13) 10.17§
Amendment to Diagnostic, Collaboration and Option Agreement, dated October 1, 2007, by and between ARCA Discovery, Inc. and CardioDX, Inc.(13)
10.18§ Manufacturing Agreement, dated September 11, 2006, by and between ARCA Discovery, Inc. and Patheon, Inc.(13) 10.19§
Development, Commercialization and Licensing Agreement, dated February 1, 2007, by and between ARCA Discovery, Inc. and Laboratory Corporation of America Holdings, Inc.(14)
Table of Contents
Exhibit
Number Description
10.20
Amendment No. 1 to Development, Commercialization and Licensing Agreement, dated May 14, 2007, by and between ARCA Discovery, Inc. and Laboratory Corporation of America Holdings, Inc.(13)
10.21§
Amendment No. 2 to Development, Commercialization and Licensing Agreement, dated June 10, 2008, by and between ARCA Discovery, Inc. and Laboratory Corporation of America Holdings, Inc.(13)
10.22 Materials Transfer Agreement, dated October 14, 2005, by and between ARCA Discovery, Inc. and the University of Colorado.(13) 10.23 Equity Distribution Agreement, dated December 8, 2009, between ARCA biopharma, Inc. and Wedbush Securities, Inc.(9) 10.24
Amendment no. 1, dated April 30, 2010 to the Equity Distribution Agreement dated December 8, 2009 between ARCA biopharma, Inc. and Wedbush Securities, Inc.(19)
10.25 Lease Surrender and Termination Agreement, dated August 5, 2009, by and between ARCA biopharma, Inc. and The Irvine Company LLC.(10) 10.26
Lease Termination and Warrant Purchase Agreement, dated September 18, 2009, by and between ARCA biopharma, Inc., BMR-201 Industrial Road LLC and BioMed Realty, L.P.(11)
10.27§ Exclusive Option Agreement, dated December 2, 2009, by and between ARCA biopharma, Inc. and the University of Cincinnati. (17) 10.28
Agreement Term Extension Letter dated December 8, 2010, of the Exclusive Option Agreement by and between ARCA biopharma, Inc. and the University of Cincinnati.(21)
10.29
Agreement Term Extension Letter dated December 21, 2010, of the Exclusive Option Agreement by and between ARCA biopharma, Inc. and the University of Cincinnati.(22)
10.30
Agreement Term Extension Letter dated January 21, 2011, of the Exclusive Option Agreement by and between ARCA biopharma, Inc. and the University of Cincinnati.(23)
10.31† ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7)
10.32† Amendment No. 1 to the ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7) 10.33† Amendment No. 2 to the ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7) 10.34† Amendment No. 3 to the ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7) 10.35† Amendment No. 4 to the ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7) 10.36† Amendment No. 5 to the ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7) 10.37† Amendment No. 6 to the ARCA Discovery, Inc. 2004 Stock Incentive Plan.(7)
10.38† ARCA biopharma, Inc. 2004 Stock Incentive Plan, Form of Executive Incentive Stock Option Agreement.(7) 10.39† ARCA biopharma, Inc. 2004 Stock Incentive Plan, Form of Non-Executive Incentive Stock Option Agreement.(7) 10.40† ARCA biopharma, Inc. 2004 Stock Incentive Plan, Form of Nonqualified Stock Option Agreement.(7)
10.41†
ARCA biopharma, Inc. 2004 Equity Incentive Plan (f/k/a Nuvelo, Inc. 2004 Equity Incentive Plan), Form of Partial Acceleration Stock Option Agreement.(8)
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Exhibit
Number Description
10.42†
ARCA biopharma, Inc. 2004 Equity Incentive Plan (f/k/a Nuvelo, Inc. 2004 Equity Incentive Plan), Form of No Acceleration Stock Option Agreement.(8)
10.43†
ARCA biopharma, Inc. 2004 Equity Incentive Plan (f/k/a Nuvelo, Inc. 2004 Equity Incentive Plan), Form of Director Stock Option Agreement.(8)
10.44†
ARCA biopharma, Inc. 2004 Equity Incentive Plan (f/k/a Nuvelo, Inc. 2004 Equity Incentive Plan), Form of Notice of Grant of Stock Option. (8)
10.45†
ARCA biopharma, Inc. 2004 Equity Incentive Plan (f/k/a Nuvelo, Inc. 2004 Equity Incentive Plan), Form of Notice of Director Grant of Stock Option.(8)
10.46† Form of Indemnification Agreement between Nuvelo, Inc. and its directors and officers.(1) 10.47† Nuvelo, Inc. Amended Executive Change in Control and Severance Benefit Plan.(4) 10.48†
Amended and Restated Employment and Retention Agreement, dated June 4, 2008, by and between ARCA biopharma, Inc. and Michael R. Bristow.(8)
10.49
Assignment and Assumption Agreement, dated January 26, 2009, by and between ARCA biopharma, Inc. and ARCA biopharma Colorado, Inc.(8)
10.50† Amended and Restated Employment Agreement, dated June 12, 2008, by and between ARCA biopharma, Inc. and Christopher D. Ozeroff.(8) 10.51
Assignment and Assumption Agreement, dated January 26, 2009, by and between ARCA biopharma, Inc. and ARCA biopharma Colorado, Inc.(8)
10.52† Amended and Restated ARCA biopharma, Inc. 2004 Equity Incentive Plan(12) 10.53† ARCA biopharma, Inc. Employee Severance Benefit Plan(20)
10.54† ARCA biopharma, Inc. 2009 Reduction in Force Severance Benefit Plan(20) 10.55†
Form of Option Amendment pursuant to ARCA biopharma, Inc. 2004 Equity Incentive Plan and ARCA biopharma, Inc. 2004 Stock Option Plan (change of control)(20)
10.56†
Form of Option Agreement and Grant Notice pursuant to ARCA biopharma, Inc. 2004 Equity Incentive Plan (NDA/change of control acceleration)(20)
10.57† Employment Agreement, dated February 11, 2009, by and between ARCA biopharma, Inc. and Patrick Wheeler.(17) 10.58 Form of Indemnification Agreement between ARCA biopharma, Inc. and its directors and officers.(8)
14.1 Code of Business Conduct and Ethics(10)
16.1 Letter from Ernst & Young LLP to the Securities and Exchange Commission, dated March 30, 2009.(16) 23.1* Consent of KPMG LLP, Independent Registered Public Accounting Firm.
24.1* Power of Attorney (included in the signature page hereto). 31.1*
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. sec. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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* Filed herewith.
† Compensatory plan or agreement.
§ Confidential treatment has been requested for portions of this document, which are omitted and filed separately with the SEC.
(1) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from Hyseq, Inc.'s Form S-1, filed on June 12, 1997, as amended, File No. 333-29091.
(2) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from Nuvelo, Inc.'s Form 10-Q, filed on November 8, 2006, File No. 000-22873.
(3) Previously filed with the SEC as an Appendix to and incorporated herein by reference from Nuvelo, Inc.'s Proxy Statement on Schedule 14A, filed on April 18, 2007, File No. 000-22873.
(4) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from Nuvelo, Inc.'s Form 10-Q, filed on November 7, 2007, File No. 000-22873.
(5) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from Nuvelo, Inc.'s Form 8-K, filed on September 25, 2008, File No. 000-22873.
(6) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from Nuvelo, Inc.'s Form 8-K, filed on October 29, 2008, File No. 000-22873.
(7) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on January 28, 2009, File No. 000-22873.
(8) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-K, filed on March 27, 2009, File No. 000-22873.
(9) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on December 8, 2009, File No. 000-22873.
(10) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-Q, filed on November 16, 2009, File No. 000-22873.
(11) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on September 24, 2009, File No. 000-22873.
(12) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-Q/A, filed on August 21, 2009, File No. 000-22873.
(13) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-Q, filed on May 15, 2009, File No. 000-22873.
(14) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-Q/A, filed on November 6, 2009, File No. 000-22873.
(15) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on April 10, 2009, File No. 000-22873.
(16) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on March 30, 2009, File No. 000-22873.
(17) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-K, filed on March 4, 2010, File No. 000-22873.
(18) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-Q, filed on August 10, 2010, File No. 000-22873.
(19) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on April 30, 2010, File No. 000-22873.
(20) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 10-Q, filed on August 10, 2009, File No. 000-22873.
(21) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on December 14, 2010, File No. 000-22873.
(22) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on December 22, 2010, File No. 000-22873.
(23) Previously filed with the SEC as an Exhibit to and incorporated herein by reference from ARCA biopharma, Inc.'s Form 8-K, filed on January 26, 2011, File No. 000-22873.
Exhibit 23.1 Consent of Independent Registered Public Accounting Firm
The Board of Directors ARCA biopharma, Inc.:
We consent to the incorporation by reference in the registration statements (Nos. 333-161485, 333-146078, 333-134981, 333-126590, 333-115747, 333-108563, 333-103055, 333-101276, 333-96313, 333-68172, 333-68170, 333-53089, 333-53087, 333-41663, 333-39194, 333-08978, and 333-154839) on Form S-8 of ARCA biopharma, Inc. of our report dated March 8, 2011, with respect to the consolidated balance sheets of ARCA biopharma, Inc. as of December 31, 2010 and 2009, and the related consolidated statements of operations, preferred stock and stockholders' equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2010, and for the period from December 17, 2001 (inception) to December 31, 2010, which report appears in the December 31, 2010 annual report on Form 10-K of ARCA biopharma, Inc.
Our report dated March 8, 2011 contains an explanatory paragraph that states that the Company's recurring losses from operations and its dependence upon raising additional funds from strategic transactions, sales of equity, and/or issuance of debt raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of that uncertainty.
/s/ KPMG LLP Denver, Colorado
Exhibit 31.1 CERTIFICATION
I, Michael R. Bristow, certify that:
1.
I have reviewed this annual report on Form 10-K of ARCA biopharma, Inc.;2. Based on my knowledge, this annual 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 annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in the report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this annual report based on such evaluation;