UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2014 (January 10, 2014)
FIBROCELL SCIENCE, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-31564 | 87-0458888 | ||
(State or Other Jurisdiction | (Commission | (I.R.S. Employer | ||
of Incorporation) | File Number) | Identification No.) |
405 EAGLEVIEW BLVD., EXTON, PA 19341
(Address of Principal Executive Office) (Zip Code)
(484) 713-6000
(Registrants telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01. | Entry into a Material Definitive Agreement. |
On January 10, 2014, Fibrocell Science, Inc. (the Company) and Intrexon Corporation (Intrexon) entered into a Second Amendment (the Second Amendment) to the parties Exclusive Channel Collaboration Agreement dated October 5, 2012, as previously amended on June 28, 2013 (the Channel Agreement and such previous amendment, the First Amendment). The Channel Agreement provides for a channel collaboration arrangement governing a strategic collaboration for the development and commercialization of genetically modified and non-genetically modified autologous fibroblasts and autologous dermal cells in the United States.
The Channel Agreement originally granted the Company an exclusive license to use proprietary technologies and other intellectual property of Intrexon to research, develop, use, import, export, make, have made, sell, and offer for sale certain products in the Field in the United States. The Field in the Channel Agreement originally include: (a) the enhanced production and purification of non-genetically modified autologous fibroblasts for all aesthetic and therapeutic indications; (b) the enhanced production and purification of non-genetically modified autologous dermal cells for aesthetic and therapeutic treatment of dermal, vocal cord, and periodontal indications; (c) the development of genetically modified autologous fibroblasts for all aesthetic and therapeutic indications; and (d) the development of genetically modified autologous dermal cells for aesthetic and therapeutic treatment of dermal, vocal cord, and periodontal indications. Pursuant to the first amendment executed on June 28, 2013, the Field in the Channel Agreement was amended to add autologous human fibroblasts genetically modified to express a therapeutic protein and/or bioactive RNA for the treatment of autoimmune and non-infectious inflammatory disorders that manifest in cutaneous tissues, fascia and/or muscle. Pursuant to Second Amendment, the Field in the Channel Agreement was further amended to add autologous human fibroblasts genetically modified to express bioactive Tenascin X locally to correct connective tissue disorders. The remainder of the Channel Agreement was unchanged and the terms of the Channel Agreement will apply to the amended Field.
In connection with the execution of the Second Amendment, on January 10, 2014, the Company and Intrexon entered into a Supplemental Stock Issuance Agreement (the Supplemental Stock Issuance Agreement) pursuant to which the Company agreed to issue to Intrexon, who is an affiliate of NRM VII Holdings I, LLC, the Companys largest shareholder, a number of shares of Company common stock valued at $5.0 million based on a per share value of $4.88 per share, which was the closing price of the Companys common stock on the NYSE MKT on the day prior to execution of the Supplemental Stock Issuance Agreement (the Supplemental Access Fee Shares), which issuance will be deemed paid in partial consideration for the execution and delivery of the Second Amendment. The Supplemental Access Fee Shares will be issued upon the satisfaction of customary closing conditions, including the approval for the listing of the Supplemental Access Fee Shares on the NYSE MKT.
The foregoing summaries of the Second Amendment, Supplemental Stock Issuance Agreement, Channel Agreement and First Amendment do not purport to be complete and are qualified in their entirety by reference to the definitive documents attached hereto as Exhibits 10.1, 10.2, 10.3 and 10.4 respectively, which are incorporated herein by reference.
The press release dated January 13, 2014 announcing the transactions described above is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 3.02. | Unregistered Sales of Equity Securities |
The information contained in Item 1.01 is hereby incorporated by reference. The Supplemental Access Fee Shares were issued in a transaction exempt from registration under the Securities Act of 1933, as amended (the Securities Act), in reliance on Section 4(2) thereof. Intrexon represented that it was an accredited investor as defined in Regulation D of the Securities Act.
Item 7.01. | Regulation FD Disclosure. |
On January 13, 2014, the Company posted the presentation attached as Exhibit 99.2 on its web site. The presentation is incorporated by reference herein.
The information contained in Item 7.01 and Exhibit 99.2 to this report (i) is not to be considered filed under the Securities Exchange Act of 1934, as amended (the Exchange Act) and (ii) shall not be incorporated by reference into any previous or future filings made by or to be made by the Company with the Securities and Exchange Commission (SEC) under the Securities Act of 1933, as amended, or the Exchange Act.
The information contained in Exhibit 99.2 contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements contained therein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Companys control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A Risk Factors in the Companys Annual Report on Form 10-K for the year ended December 31, 2012, as updated in Item 1A. Risk Factors in the Companys Quarterly Reports on Form 10-Q filed since the annual report, as well as in its Form 8-K dated September 26, 2013. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit Number |
Description |
|
10.1 | Second Amendment to Exclusive Channel Collaboration Agreement between the Company and Intrexon dated January 10, 2014 | |
10.2 | Supplemental Stock Issuance Agreement between the Company and Intrexon dated January 10, 2014 | |
10.3 | Exclusive Channel Collaboration Agreement between the Company and Intrexon dated October 5, 2012 (incorporated by reference to Exhibit 10.21 of the Companys Form 10-K for the year ended December 31, 2012) * | |
10.4 | First Amendment to Exclusive Channel Collaboration Agreement between the Company and Intrexon dated June 28, 2013 (incorporated by reference to Exhibit 10.1 of the Companys Current Report on Form 8-K filed with the Securities and Exchange Commission on July 1, 2013) | |
99.1 | Press Release dated January 13, 2014. | |
99.2 | Investor Presentation dated January 13, 2014. |
* | Confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been granted with respect to this omitted information. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
Fibrocell Science, Inc.
|
||
By: |
/s/ Gregory Weaver |
|
Gregory Weaver Chief Financial Officer |
Date: January 13, 2014
Exhibit 10.1
EXECUTION COPY
SECOND AMENDMENT TO EXCLUSIVE CHANNEL COLLABORATION AGREEMENT
THIS SECOND AMENDMENT is entered into as of this 10 th day of January, 2014 and serves to amend the Exclusive Channel Collaboration Agreement entered into by and between Intrexon Corporation (Intrexon) and Fibrocell Science, Inc. (Fibrocell), on October 5, 2012 and first amended on June 28, 2013 (as amended, the Agreement). All capitalized terms not defined herein shall have the meaning set forth in the Agreement.
WHEREAS , Intrexon has expertise in and owns or controls proprietary technology relating to the identification, design and production of genetically modified cells and DNA vectors, and the control of expression of proteins and bioactive RNA species; and
WHEREAS , pursuant to the Agreement, Fibrocell is currently Intrexons exclusive channel collaborator with the right to use Intrexon technology to research, develop and commercialize products for use in a specific Field (as defined in the Agreement); and
WHEREAS , Fibrocell now desires to broaden the scope of its rights under the Agreement in order to research, develop and commercialize products for use in certain additional areas as more fully described below, and Intrexon is willing to grant such additional rights in exchange for certain compensation as more fully described below.
NOW THEREFORE , in consideration of the foregoing and the covenants and promises contained herein, the Parties hereby agree to amend the Agreement pursuant to Section 12.7 thereof as follows:
1. | Section 1.29 of the Agreement is hereby replaced in its entirety with the following: |
1.29 Field means, as of the Effective Date and irrespective of whether such requires regulatory approval, (i) the enhanced production and purification of non-genetically modified human autologous fibroblasts for use in all aesthetic and therapeutic indications; (ii) the enhanced production and purification of non-genetically modified human autologous dermal cells for use in aesthetic and therapeutic treatment of dermal, vocal cord, and periodontal indications; (iii) the development of genetically modified autologous human fibroblasts for use in all aesthetic and therapeutic indications where an autologous fibroblast itself is the principal effector of the product in contrast to the use of autologous fibroblasts as the source of expression of a systemically available therapeutic protein in which that protein (and not the fibroblast per se) is the principal therapeutic effector; (iv) the development of genetically modified autologous human dermal cells for aesthetic and therapeutic treatment of dermal, vocal cord, and periodontal indications; (v) autologous human fibroblasts genetically modified to express a therapeutic protein and/or bioactive RNA for the treatment of autoimmune and non-infectious inflammatory disorders that manifest in cutaneous tissues, fascia and/or muscle, and (vi) autologous human fibroblasts genetically modified to express bioactive Tenascin X locally to correct connective tissue disorders. For clarity, the Field does not include inductive pluripotent cell products that are derived from autologous fibroblasts or dermal cells or products that are subject to an existing Intrexon collaboration.
2. | In partial consideration for the additional rights granted to Fibrocell hereunder, Fibrocell shall issue to Intrexon, as an additional access fee for commercial license rights to the Intrexon IP granted hereunder, certain shares of the common stock of Fibrocell (the Supplemental Access Fee). The Supplemental Access Fee will be that number of shares of Fibrocell common stock (the Supplemental Access Fee Shares) having a value equaling approximately $5,000,000, and such shares issuance will occur pursuant to the terms of a Supplemental Stock Issuance Agreement of even date herewith (the Issuance Agreement). Provided that all closing conditions for the Supplemental Access Fee Shares (as defined in the Issuance Agreement) that are within the reasonable control of Intrexon have been satisfied or waived, the issuance of the Supplemental Access Fee Shares is a condition subsequent to the effectiveness of this Amendment. |
3. | The Parties hereby acknowledge that the Supplemental Access Fee Shares shall constitute Registrable Securities as defined in that certain Registration Rights Agreement, dated October 5, 2012, between the Parties. |
4. | Fibrocell hereby represents and warrants to Intrexon that, as of the date of this Amendment: |
a. | Corporate Power . Fibrocell is duly organized and validly existing under the laws of Delaware and has full corporate power and authority to enter into this Amendment and to carry out the provisions hereof. |
b. | Due Authorization . Fibrocell is duly authorized to execute and deliver this Amendment and to perform its obligations hereunder, and the person executing this Amendment on Fibrocells behalf has been duly authorized to do so by all requisite corporate action. |
5. | Intrexon hereby represents and warrants to Fibrocell that, as of the date of this Amendment: |
a. | Corporate Power . Intrexon is duly organized and validly existing under the laws of Virginia and has full corporate power and authority to enter into this Amendment and to carry out the provisions hereof. |
b. | Due Authorization . Intrexon is duly authorized to execute and deliver this Amendment and to perform its obligations hereunder, and the person executing this Amendment on Intrexons behalf has been duly authorized to do so by all requisite corporate action. |
6. | The Parties agree that the public announcement of the execution of this Amendment shall be substantially in the form of a press release and/or the filing of a Form 8-K by Fibrocell, which shall be mutually agreed to by the Parties. |
7. | All other terms and conditions of the Agreement remain in full force and effect. |
[Signature Page Follows]
IN WITNESS WHEREOF , the parties hereto have duly executed this Second Amendment to Exclusive Channel Collaboration Agreement by authorized representatives as of the date written above.
INTREXON CORPORATION | ||
By: | /s/ Gregory Frost | |
Name: Gregory Frost | ||
Title: SVP Health Sector |
FIBROCELL SCIENCE, INC. | ||
By: | /s/ David Pernock | |
Name: David Pernock | ||
Title: CEO |
Exhibit 10.2
EXECUTION COPY
SUPPLEMENTAL STOCK ISSUANCE AGREEMENT
T HIS S UPPLEMENTAL S TOCK I SSUANCE A GREEMENT ( Agreement ) is made and entered into as of January 10, 2014 (the Effective Date ), by and among Fibrocell Science, Inc., a Delaware corporation (the Company ) and Intrexon Corporation, a Virginia corporation ( Intrexon ).
A. Concurrently with the execution of this Agreement, the Company is entering into a Second Amendment (the Amendment ) to that certain Exclusive Channel Collaboration Agreement, dated October 5, 2012 and previously amended on June 28, 2013, with Intrexon (as amended, the Channel Agreement ), pursuant to which Intrexon is licensing additional rights to certain technology to the Company; and
B. In consideration of such additional license to the Company under the Channel Agreement, the Company has agreed to issue to Intrexon certain shares of the Companys common stock, par value $0.001 per share ( Common Stock ) in accordance with the terms and conditions of this Agreement.
C. The parties have previously entered into a Registration Rights Agreement, dated October 5, 2013 (the Rights Agreement ).
NOW THEREFORE, in consideration of the mutual covenants contained in this Agreement and for other good and valuable consideration, the receipt of which is hereby acknowledged, the Company and Intrexon hereby agree as follows:
SECTION 1. A UTHORIZATION OF ISSUANCE OF S HARES .
1.1 Supplemental Access Fee Shares . Subject to the terms and conditions of this Agreement, the Company has authorized the issuance to Intrexon of that number of shares of the Companys Common Stock having a Fair Market Value of $5,000,000 ( Supplemental Access Fee Shares ) at the Closing (as hereinafter defined).
1.2 Calculation of Fair Market Value . Fair Market Value of the Common Stock for purposes of calculating the number of Supplemental Access Fee Shares shall be the per share closing sales price of the Common Stock, as reported by the NYSE MKT, on the trading day immediately preceding the date of the Amendment.
1.3 Capital Adjustments . If after the date hereof and prior to the date the Supplemental Access Fee Shares are issued (i) the outstanding shares of the Companys Common Stock shall be subdivided or split into a greater number of shares or a dividend in Common Stock shall be paid in respect of such Common Stock or (ii) the outstanding shares of Common Stock are combined, then all share quantities in this Agreement not yet issued shall be appropriately adjusted to reflect such stock split, stock dividend or conjunction.
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SECTION 2. C LOSING AND D ELIVERY
2.1 Issuance of Supplemental Access Fee Shares . Subject to the terms and conditions of this Agreement and the Channel Agreement, as amended, and in reliance upon the representations, warranties and agreements contained herein, the Company will issue to Intrexon the Supplemental Access Fee Shares. The Parties agree that the consideration received by the Company hereunder shall be the execution and delivery by Intrexon of the Amendment which consideration is at least equal to the par value of the Supplemental Access Fee Shares issued hereunder.
2.2 Closing . The closing of the issuance of the Supplemental Access Fee Shares shall be held at the offices of the Company or at such other place as the Company and Intrexon may agree, and shall occur, subject to the conditions set forth in Section 8 hereof and applicable to the Supplemental Access Fee Shares Closing, on such other date as Intrexon and the Company may agree upon but in no event later than January 24, 2014 (the Closing ).
2.3 Delivery of the Shares . Promptly following the Closing, the Company shall deliver to Intrexon a certificate representing the Supplemental Access Fee Shares required to be issued the Closing, registered in the name of Intrexon.
SECTION 3. R EPRESENTATIONS AND W ARRANTIES OF THE C OMPANY .
Subject to and except as set forth in the SEC Documents, the Company hereby represents and warrants to Intrexon as of the date hereof as follows:
3.1 Organization, Good Standing and Power . The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware and has the requisite corporate power to own, lease and operate its properties and assets and to conduct its business as it is now being conducted and as described in the reports filed by the Company with the Securities and Exchange Commission (the Commission ) pursuant to the reporting requirements of the Securities Exchange Act of 1934, as amended (the Exchange Act ), since the end of its most recently completed fiscal year through the date hereof, including, without limitation, its most recent report on Form 10-Q. The Company does not have any subsidiaries other than those identified in its most recent report on Form 10-Q. The Company is qualified to do business as a foreign corporation and is in good standing in every jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except for any jurisdiction(s) (alone or in the aggregate) in which the failure to be so qualified will not have a Material Adverse Effect. For the purposes of this Agreement, Material Adverse Effect means any effect on the business, operations, properties or financial condition of the Company that is material and adverse to the Company, taken as a whole, and any condition, circumstance or situation that would prohibit the Company from entering into and performing any of its obligations hereunder.
3.2 Authorization; Enforcement . The Company has the requisite corporate power and authority to enter into and perform this Agreement and to issue the shares in accordance with the terms hereof. The execution, delivery and performance of this Agreement by the Company and the consummation by it of the transactions contemplated hereby have been duly and validly
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authorized by all necessary corporate action, and no further consent or authorization of the Company, its board of directors or stockholders is required, except pursuant to Section 8. When executed and delivered by the Company, this Agreement shall constitute a valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, reorganization, moratorium, liquidation, conservatorship, receivership or similar laws relating to, or affecting generally the enforcement of, creditors rights and remedies or by other equitable principles of general application. The Companys board of directors, at a meeting duly called and held, adopted resolutions approving the transactions contemplated hereby, including the issuance of the Supplemental Access Fee Shares.
3.3 Issuance of Shares . The shares to be issued and sold hereunder have been duly authorized by all necessary corporate action and, when issued in accordance with the terms hereof, will be validly issued, fully paid and nonassessable. In addition, such shares will be free and clear of all liens, claims, charges, security interests or agreements, pledges, assignments, covenants, restrictions or other encumbrances created by, or imposed by, the Company (collectively, Encumbrances ) and rights of refusal of any kind imposed by the Company (other than restrictions on transfer under applicable securities laws) and the holder of such shares shall be entitled to all rights accorded to a holder of Common Stock.
3.4 No Conflicts; Governmental Approvals . The execution, delivery and performance of the Agreement by the Company and the consummation by the Company of the transactions contemplated hereby do not and will not (i) violate any provision of the Companys Articles of Incorporation or Bylaws, each as amended to date, (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, mortgage, deed of trust, indenture, note, bond, license, lease agreement, instrument or obligation to which the Company is a party or by which the Companys properties or assets are bound, or (iii) result in a violation of any federal, state, local or foreign statute, rule, regulation, order, judgment or decree (including federal and state securities laws and regulations) applicable to the Company or by which any property or asset of the Company is bound or affected, except for such conflicts, defaults, terminations, amendments, acceleration, cancellations and violations as would not, individually or in the aggregate, have a Material Adverse Effect. The Company is not required under federal, state, foreign or local law, rule or regulation to obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency in order for it to execute, deliver or perform any of its obligations under this Agreement or issue and sell the shares in accordance with the terms hereof (other than any filings, consents and approvals which may be required to be made by the Company under applicable state and federal securities laws, rules or regulations prior to or subsequent to the Closing).
3.5 Commission Documents, Financial Statements . The Common Stock of the Company is registered pursuant to Section 12(b) of the Exchange Act. During the year preceding this Agreement, the Company has timely filed all reports, schedules, forms, statements and other documents required to be filed by it with the Commission pursuant to the reporting requirements of the Exchange Act (such filings, including such filings made on the date of this Agreement, the SEC Documents ). At the times of their respective filing, all such reports, schedules, forms, statements and other documents complied in all material respects with the
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requirements of the Exchange Act and the rules and regulations of the Commission promulgated thereunder. At the times of their respective filings, such reports, schedules, forms, statements and other documents did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. As of their respective dates, the financial statements of the Company included in the SEC Documents complied in all material respects with applicable accounting requirements and the published rules and regulations of the Commission or other applicable rules and regulations with respect thereto. Such financial statements have been prepared in accordance with generally accepted accounting principles applied on a consistent basis during the periods involved (except (i) as may be otherwise indicated in such financial statements or the notes thereto or (ii) in the case of unaudited interim statements, to the extent they may not include footnotes or may be condensed or summary statements), and fairly present in all material respects the consolidated financial position of the Company as of the dates thereof and the results of operations and cash flows for the periods then ended (subject, in the case of unaudited statements, to normal year-end audit adjustments).
3.6 Accountants. BDO USA LLP, whose report on the financial statements of the Company is filed with the SEC in the Companys Annual Report on Form 10-K for the year ended December 31, 2012, were, at the time such report was issued, independent registered public accountants as required by the Securities Act of 1933 and the rules and regulations promulgated thereunder (together, the Securities Act ).
3.7 Internal Controls . The Company has established and maintains a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with managements general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles in the United States and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with managements general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
3.8 Disclosure Controls . The Company has established and maintains disclosure controls and procedures (as such term is defined in Rules 13a-15 and 15d-15 under the Exchange Act). Since the date of the most recent evaluation of such disclosure controls and procedures, there have been no significant changes in internal controls or in other factors that could significantly affect internal controls, including any corrective actions with regard to significant deficiencies and material weaknesses. The Company is in compliance in all material respects with all provisions currently in effect and applicable to the Company of the Sarbanes-Oxley Act of 2002, and all rules and regulations promulgated thereunder or implementing the provisions thereof.
3.9 No Material Adverse Change . Except as disclosed in the SEC Documents or as a result of the Equity Financing (including any conditions precedent to completing such Equity Financing), since November 14, 2013, the Company has not (i) experienced or suffered any Material Adverse Effect, (ii) incurred any material liabilities, obligations, claims or losses (whether liquidated or unliquidated, secured or unsecured, absolute, accrued, contingent or otherwise) other than those incurred in the ordinary course of the Companys business or (iii) declared, made or paid any dividend or distribution of any kind on its capital stock.
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3.10 No Undisclosed Events or Circumstances . Except as disclosed in the SEC Documents, since November 14, 2013, except for the consummation of the transactions contemplated herein, to the Companys knowledge, no event or circumstance has occurred or exists with respect to the Company or its businesses, properties, prospects, operations or financial condition, which, under applicable law, rule or regulation, requires public disclosure or announcement by the Company but which has not been so publicly announced or disclosed.
3.11 Litigation . No action, suit, proceeding or investigation is currently pending or, to the knowledge of the Company, has been threatened in writing against the Company that: (i) concerns or questions the validity of this Agreement; (ii) concerns or questions the right of the Company to enter into this Agreement; or (iii) is reasonably likely to have a Material Adverse Effect. The Company is neither a party to nor subject to the provisions of any material order, writ, injunction, judgment or decree of any court or government agency or instrumentality. There is no action, suit, proceeding or investigation by the Company currently pending or that the Company intends to initiate that would have a Material Adverse Effect.
3.12 Compliance . Except for defaults or violations which are not reasonably likely to have a Material Adverse Effect, the Company is not (i) in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company under), nor has the Company received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any order of any court, arbitrator or governmental body, or (iii) is or has been in violation of any statute, rule or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws, applicable to its business, except in each case for such defaults or violations as would not have a Material Adverse Effect.
3.13 Intellectual Property . The Company and its United States subsidiaries ( Subsidiaries ) solely own, or, to the knowledge of the Company, possess valid and enforceable licenses to use or sublicense inventions, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), trademarks, service marks and trade names, patents and patent rights and other intellectual property (collectively Intellectual Property ) material to carrying on their businesses as described in the SEC Documents (collectively, Company Intellectual Property ), such ownership and, to the knowledge of the Company, such licenses, being free and clear of all liens, encumbrances and defects and challenges by others, except such as are described in the SEC Documents, and the Company has taken all reasonable steps to secure its interests in the Company Intellectual Property, including obtaining assignments of owned Company Intellectual Property from its employees and contractors. Issued patents within the Company Intellectual Property, together with patent applications within the Company Intellectual Property, if such patent applications result in issued patents with claims having substantially the same scope as the claims of such patent applications as of the date hereof, claim the Companys current marketed products and products in development, for the indications
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currently approved and currently being developed. Neither the Company nor any Subsidiary has received any written correspondence relating to or asserting rights in any Company Intellectual Property, or written notice of infringement, misappropriation or violation of asserted rights of others in any Intellectual Property, which, in either case, would render any Company Intellectual Property invalid or unenforceable or bring into question the Companys and the Subsidiaries ownership of any Company Intellectual Property. To the knowledge of the Company, the conduct and the proposed conduct of the businesses of the Company and its Subsidiaries, including the research, development, manufacture, sale and use of its current products and its products in development, as described in the SEC Documents, does not, and is not reasonably expected to, infringe or misappropriate the valid Intellectual Property rights of any third party. The Company is not aware of any facts or circumstances that would reasonably be expected to render any Company Intellectual Property invalid or unenforceable, and the Company is not aware of any material commercial infringement or misappropriation by any third party of any Company Intellectual Property. None of the Company Intellectual Property is or has been involved in any opposition, cancellation, interference, reissue or reexamination proceeding and no Company Intellectual Property is the subject of any judicial, administrative or arbitral order, award, decree, injunction, lawsuit, proceeding or stipulation, other than review by patent offices of pending applications for patents in the ordinary course or review in connection with potential extension of patent term. There are no outstanding options, licenses or agreements of any kind that have been entered into by the Company, and to the knowledge of the Company, by any third party, that relate to the Company Intellectual Property that are required by applicable law to be described in the SEC Documents that are not described therein in all material respects. None of the Intellectual Property used by the Company or any of the Subsidiaries has been obtained or is being used by the Company or its Subsidiaries in violation of any contractual obligation binding on the Company, any of the Subsidiaries or, to the knowledge of the Company, any of the officers, directors or employees of the Company or any of the Subsidiaries, other than such violations as would not individually or in the aggregate if the subject of an unfavorable decision, ruling or finding, reasonably be expected to have a Material Adverse Effect. Person means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
3.14 FDA Compliance . Except as described in the SEC Documents, and except as would not, individually or in the aggregate, have or would reasonably be expected to have a Material Adverse Effect (i) neither the Company nor any of the Subsidiaries has received any unresolved FDA Form 483, warning letter or untitled letter from the U.S. Food and Drug Administration ( FDA ), or any other court or arbitrator or federal, state, local or foreign governmental or regulatory authority, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the FFDCA ) or similar law, (ii) the Company and each of the Subsidiaries is and has been in compliance with applicable health care laws, including without limitation, the FFDCA, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)(2)), the civil False Claims Act (31 U.S.C. §§ 3729(a) et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), and the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Public Law 111-152), and the regulations promulgated pursuant to such laws, and comparable state
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laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions and written administrative guidance relating to the regulation of the Company (collectively, Health Care Laws ), (iii) the Company and each of the Subsidiaries possesses all licenses, certificates, approvals, clearances, authorizations and permits required by any such Health Care Laws and/or to carry on its businesses as now conducted ( Authorizations ) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations, (iv) neither the Company nor any of the Subsidiaries has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement action, investigation or arbitration from any U.S. or non-U.S. federal, state, local or other governmental or regulatory authority, governmental or regulatory agency or body, court or arbitrator (each, a Governmental Authority ) or third party alleging that any product operation or activity is in violation of any Health Care Laws or Authorizations or has any knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, (v) neither the Company nor any of the Subsidiaries has received written notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Authority is considering such action, (vi) the Company and each of the Subsidiaries has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission), and (vii) neither the Company nor any of the Subsidiaries has, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert (but excluding adverse event reports in clinical trials), post sale warning, dear doctor letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Companys knowledge, no third party has initiated or conducted any such notice or action.
3.15 Application of Takeover Protections . The issuance of the Supplemental Access Fee Shares hereunder and Intrexons ownership thereof is not prohibited by the business combination statutes of the state of Delaware. The Company has not adopted any stockholder rights plan, poison pill or similar arrangement that would trigger any right, obligation or event as a result of the issuance of such Supplemental Access Fee Shares and Intrexons ownership of such shares and there are no similar anti-takeover provisions under the Companys charter documents.
3.16 Listing and Maintenance Requirements . The Company is in compliance with the requirements of the NYSE MKT for continued listing of the Common Stock thereon. The issuance and sale of the shares hereunder does not contravene the rules and regulations of the NYSE MKT.
3.17 Private Placement. Neither the Company nor its Affiliates, nor any Person acting on its or their behalf, (i) has engaged in any form of general solicitation or general advertising (within the meaning of Regulation D under the Securities Act) in connection with the offer or sale of the shares hereunder, (ii) has, directly or indirectly, made any offers or sales of any
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security or solicited any offers to buy any security, under any circumstances that would require registration of the sale and issuance by the Company of the shares under the Securities Act or (iii) has issued any shares of Common Stock or shares of any series of preferred stock or other securities or instruments convertible into, exchangeable for or otherwise entitling the holder thereof to acquire shares of Common Stock which would be integrated with the sale of the shares to Intrexon for purposes of requiring registration of such shares pursuant to the Securities Act or for the purpose of any applicable stockholder approval provisions, including, without limitation, under the rules and regulations of any exchange or automated quotation system on which any of the securities of the Company are listed or designated, nor will the Company or any of its subsidiaries or affiliates take any action or steps that would require registration of any of the shares under the Securities Act or cause the offering of the shares to be integrated with other offerings. Assuming the accuracy of the representations and warranties of Intrexon, the offer and issuance of the shares by the Company to Intrexon pursuant to this Agreement will be exempt from the registration requirements of the Securities Act.
3.18 No Manipulation of Stock . The Company has not taken, and has no plans to take, in violation of applicable law, any action outside the ordinary course of business designed to, or that might reasonably be expected to, cause or result in unlawful manipulation of the price of the Common Stock.
3.19 Brokers . Neither the Company nor any of the officers, directors or employees of the Company has employed any broker or finder in connection with the transaction contemplated by this Agreement. The Company shall indemnify Intrexon from and against any brokers, finders or agents fees for which the Company is responsible.
SECTION 4. R EPRESENTATIONS , W ARRANTIES AND C OVENANTS OF I NTREXON .
4.1 Purchaser Sophistication . Intrexon represents and warrants to, and covenants with, the Company that Intrexon (a) is knowledgeable, sophisticated and experienced in making, and is qualified to make decisions with respect to, investments in shares presenting an investment decision like that involved in the acceptance of the shares pursuant hereto, including investments in securities issued by the Company and investments in comparable companies, and has requested, received, reviewed and considered all information it deemed relevant in making an informed decision to purchase the shares, (b) Intrexon, in connection with its decision to purchase the shares, relied only upon the SEC Documents, other publicly available information, and the representations and warranties of the Company contained herein. Intrexon is an accredited investor pursuant to Rule 501 of Regulation D under the Securities Act, (c) Intrexon is acquiring the shares for its own account for investment only and with no present intention of distributing any of such shares or any arrangement or understanding with any other persons regarding the distribution of such shares; (d) Intrexon has not been organized, reorganized or recapitalized specifically for the purpose of investing in the shares; (e) Intrexon will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire to take a pledge of) any of the shares except in compliance with the Securities Act and applicable state securities laws, (f) Intrexon understands that the shares are being offered and sold to it in reliance upon specific exemptions from the registration requirements of the Securities Act and state securities laws, and that the Company is relying upon the truth and accuracy of, and Intrexons compliance with, the representations, warranties,
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agreements, acknowledgments and understandings of Intrexon set forth herein in order to determine the availability of such exemptions and the eligibility of Intrexon to acquire the shares, (g) Intrexon understands that its investment in the shares involves a significant degree of risk, including a risk of total loss of Intrexons investment (provided that such acknowledgment in no way diminishes the representations, warranties and covenants made by the Company hereunder) and (h) Intrexon understands that no United States federal or state agency or any other government or governmental agency has passed upon or made any recommendation or endorsement of the shares.
4.2 Authorization and Power . Intrexon has the requisite power and authority to enter into and perform this Agreement. The execution, delivery and performance of this Agreement by Intrexon and the consummation by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and no further consent or authorization of Intrexon or its board of directors or stockholders is required. When executed and delivered by Intrexon, this Agreement shall constitute a valid and binding obligation of Intrexon enforceable against Intrexon in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation, conservatorship, receivership or similar laws relating to, or affecting generally the enforcement of, creditors rights and remedies or by other equitable principles of general application.
4.3 No Conflict . The execution, delivery and performance of this Agreement by Intrexon and the consummation by Intrexon of the transactions contemplated hereby do not and will not (i) violate any provision of Intrexons charter or organizational documents, (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, mortgage, deed of trust, indenture, note, bond, license, lease agreement, instrument or obligation to which Intrexon is a party or by which Intrexons properties or assets are bound, or (iii) result in a violation of any federal, state, local or foreign statute, rule, regulation, order, judgment or decree (including federal and state securities laws and regulations) applicable to Intrexon or by which any property or asset of Intrexon are bound or affected, except, in all cases, other than violations (with respect to federal and state securities laws) above, for such conflicts, defaults, terminations, amendments, acceleration, cancellations and violations as would not, individually or in the aggregate, materially and adversely affect Intrexons ability to perform its obligations under the Agreement.
4.4 Restricted Shares . Intrexon acknowledges that the shares when issued shall be restricted securities and must be held indefinitely unless subsequently registered under the Securities Act or the Company receives an opinion of counsel reasonably satisfactory to the Company that such registration is not required. Intrexon is aware of the provisions of Rule 144 promulgated under the Securities Act which permit limited resale of stock purchased in a private placement subject to the satisfaction of certain conditions, including, among other things, the existence of a public market for the stock, the availability of certain current public information about the Company, the resale occurring not less than one year after a party has purchased and paid for the stock to be sold, the sale being through a brokers transaction or a transaction directly with a market maker and the number of shares of the stock being sold during any three-month period not exceeding specified limitations. Intrexon further acknowledges and understands that the Company may not be satisfying the current public information requirement of Rule 144 at the time Intrexon wishes to sell the shares and, if so, Intrexon would be precluded from selling the shares under Rule 144 even if the one year minimum holding period has been satisfied.
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4.5 Stock Legends . Intrexon acknowledges that certificates evidencing the Supplemental Access Fee Shares shall bear a restrictive legend in substantially the following form (and including related stock transfer instructions and record notations):
4.6 THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS OR BLUE SKY LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY.
4.7 Brokers . Neither Intrexon nor any of the officers, directors or employees of Intrexon has employed any broker or finder in connection with the transaction contemplated by this Agreement. Intrexon shall indemnify the Company from and against any brokers, finders or agents fees for which Intrexon is responsible.
SECTION 5. I NDEMNIFICATIONS .
5.1 Indemnification by the Company . The Company shall, notwithstanding any termination of this Agreement, indemnify and hold harmless Intrexon, its permitted assignees, officers, directors, agents, Affiliates and employees, to the fullest extent permitted by applicable law, from and against any and all claims, losses, damages, liabilities, penalties, judgments, costs and expenses (including, without limitation, reasonable attorneys fees and expenses) (collectively, Losses ), arising out of or relating to any untrue or alleged untrue statement of a material fact contained in a Registration Statement (as defined in the Rights Agreement) or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any prospectus or form of prospectus or supplement thereto, in the light of the circumstances under which they were made) not misleading, except (i) to the extent that such untrue statements or omissions are based upon information furnished to the Company by Intrexon expressly for use in the Registration Statement; (ii) as a result of the failure of such indemnitee to deliver a prospectus, as amended or supplemented, to a purchaser in connection with an offer or sale; or (iii) the use by the indemnitee of an outdated or defective prospectus after the Company has notified Intrexon in writing that the prospectus is outdated or defective, but only if and to the extent that following such receipt the misstatement or omission giving rise to such Loss would have been corrected; provided, however, that the indemnity agreement contained in this Section 5.1 shall not apply to amounts paid in settlement of any Losses if such settlement is effected without the prior written consent of the Company, which consent shall not be unreasonably withheld.
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5.2 Indemnification by Intrexon . Intrexon shall indemnify and hold harmless the Company, its directors, officers, agents and employees to the fullest extent permitted by applicable law, from and against all Losses, as incurred, arising out of or relating to any untrue or alleged untrue statement of a material fact contained in a Registration Statement or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any prospectus or supplement thereto, in the light of the circumstances under which they were made) not misleading, to the extent that such untrue statement or omission is contained in or omitted from any information regarding Intrexon furnished in writing to the Company by Intrexon expressly for use in therein, and that such information was reasonably relied upon by the Company for use therein, or to the extent that such information relates to Intrexon or Intrexons proposed method of distribution of shares and was furnished in writing by Intrexon expressly for use therein. Notwithstanding anything to the contrary contained herein, in no event shall the liability of Intrexon under this Section 5.2 exceed the net proceeds to Intrexon as a result of the sale of shares pursuant to a Registration Statement in connection with which the untrue or alleged untrue statement or material omission was provided.
SECTION 6. S URVIVAL OF R EPRESENTATIONS , W ARRANTIES AND A GREEMENTS .
Notwithstanding any investigation made by any party to this Agreement, all representations and warranties made by the Company and Intrexon herein shall survive the execution of this Agreement and the issuance to Intrexon of the Supplemental Access Fee Shares and shall terminate one (1) year after the Closing, provided, however, that the representations and warranties in Sections 3.1, 3.2, 3.3 and 3.4 shall survive for so long as Intrexon continues to hold any of the Supplemental Access Fee Shares issued hereunder. No claim may be asserted against either party for breach of any representation or warranty contained herein, unless written notice of such claim is received by such party describing in reasonable detail and to the extent available the facts and circumstances with respect to the subject matter of such claim on or prior to the date on which the representation or warranty on which such claim is based ceases to survive as set forth above. In no event shall any party be liable to the other party for any punitive, incidental, consequential, special or indirect damages, including loss of future revenue or income, loss of business reputation or opportunity relating to the breach or alleged breach of any representation or warranty in this Agreement.
SECTION 7. C OVENANTS .
7.1 Notifications.
(a) During the period prior to the Closing, the Company will promptly advise Intrexon in writing of (i) any Material Adverse Effect, or (ii) any notice or other communication from any third person or entity alleging that the consent of the third person is required in connection with the transactions contemplated by this Agreement.
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(b) Information received by Intrexon pursuant to this Section 7.1 shall be considered Confidential Information as such term is defined in the Channel Agreement and Intrexon agrees to treat such information in accordance with the provisions of Article 7 of the Channel Agreement.
7.2 Best Efforts . Each party will use its reasonable best efforts to satisfy in a timely fashion each of the conditions to be satisfied by it under Section 8 of this Agreement.
7.3 No Poison Pill . The Company will not adopt any stockholder rights plan, poison pill or similar arrangement, or adopt any anti-takeover provisions under its charter documents, that would trigger any right, obligation or event as a result of the issuance of the Shares hereunder to Intrexon or Intrexons ownership of such Shares or the accumulation of shares of Common Stock acquired in the market by Intrexon or its affiliates.
7.4 Approval . In each case where the Company determines that the approval of any exchange or other listing upon which the Common Stock may be listed is required for the issuance of Common Stock to Intrexon, the Company shall use commercially reasonable efforts to secure such approval as promptly as possible. In the event, notwithstanding the foregoing obligation, the Company is unable to secure the approval with respect to the issuance of any Shares to be issued hereunder, the Company shall negotiate the terms of an alternate form of consideration of equivalent value to such unissued shares.
7.5 Further Assurances . Each of the Company and Intrexon shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents, as each other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement, the Channel Agreement and the consummation of the transactions contemplated thereby.
SECTION 8. C ONDITIONS TO C LOSING .
8.1 The obligation hereunder of the Company to issue shares to Intrexon at the Closing is subject to the satisfaction or waiver, at or before the Closing of the conditions set forth below. These conditions are for the Companys sole benefit and may be waived by the Company at any time in its sole discretion.
(a) Accuracy of Intrexons Representations and Warranties . The representations and warranties of Intrexon shall be true and correct as of the date when made and as of the Closing Date as though made at that time, except for representations and warranties that are expressly made as of a particular date, which shall be true and correct as of such date.
(b) Performance by Intrexon . Intrexon shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by this Agreement and the Channel Agreement to be performed, satisfied or complied by Intrexon at or prior to the Closing Date.
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(c) Amendment to Channel Agreement . The Amendment shall have been entered into by the Company and Intrexon and the Channel Agreement shall be in full force and effect.
(d) No Injunction . No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction which prohibits the consummation of any of the transactions contemplated by this Agreement.
(e) No Proceedings or Litigation . No action, suit or proceeding before any arbitrator or any governmental authority shall have been commenced, and no investigation by any governmental authority shall have been threatened in writing against Intrexon or any of the officers, directors or Affiliates of Intrexon seeking to restrain, prevent or change the transactions contemplated by this Agreement, the Channel Agreement or seeking damages in connection with such transactions.
(f) NYSE MKT Approval . The Company shall have received approval for the listing of the Supplemental Access Fee Shares on the NYSE MKT.
8.2 The obligation hereunder of Intrexon to receive Shares and consummate the transactions contemplated by this Agreement is subject to the satisfaction or waiver, at or before Closing, of each of the conditions set forth below. These conditions are for Intrexons sole benefit and may be waived by Intrexon at any time in its sole discretion.
(a) Accuracy of the Companys Representations and Warranties . Each of the representations and warranties of the Company in this Agreement shall be true and correct as of the Closing Date, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date.
(b) Performance by the Company . The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by this Agreement and the Channel Agreement to be performed, satisfied or complied with by the Company at or prior to the Closing Date.
(c) Channel Partnership Agreement . The Amendment shall have been entered into by the Company and Intrexon and the Channel Agreement shall be in full force and effect.
(d) No Injunction . No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction which prohibits the consummation of any of the transactions contemplated by this Agreement or the Channel Agreement.
(e) No Proceedings or Litigation . No action, suit or proceeding before any arbitrator or any governmental authority shall have been commenced, and no investigation by any governmental authority shall have been threatened in writing against the Company or any of the officers, directors or Affiliates of the Company seeking to restrain, prevent or change the transactions contemplated by this Agreement, the Channel Agreement or seeking damages in connection with such transactions.
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(f) No Material Adverse Effect . Since the date of this Agreement, there shall not have occurred any Material Adverse Effect.
SECTION 9. N OTICES .
All notices or other communications which are required or permitted hereunder shall be in writing and addressed as follows:
If to the Company: | Fibrocell Science, Inc. | |||||
405 Eagleview Boulevard | ||||||
Exton, PA 19341 | ||||||
Attention: Chief Executive Officer | ||||||
Fax No.: (484) 713-6001 | ||||||
If to Intrexon: | Intrexon Corporation | |||||
20374 Seneca Meadows Parkway | ||||||
Germantown, MD 20876 | ||||||
Attention: Legal Department | ||||||
Fax No.: (301) 556-9902 |
or to such other address as the party to whom notice is to be given may have furnished to the other party in writing in accordance herewith. Any such communication shall be deemed to have been given when delivered if personally delivered or sent by facsimile (provided that the party providing such notice promptly confirms receipt of such transmission with the other party by telephone), on the business day after dispatch if sent by a nationally-recognized overnight courier and on the third business day following the date of mailing if sent by certified mail, postage prepaid, return receipt requested.
SECTION 10. M ISCELLANEOUS .
10.1 Fees and Expenses . Each party shall pay the fees and expenses of its advisors, counsel, accountants and other experts, if any, and all other expenses, incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Agreement.
10.2 Waivers and Amendments . Neither this Agreement nor any provision hereof may be changed, waived, discharged, terminated, modified or amended except upon the written consent of the parties hereto.
10.3 Headings . The headings of the various sections of this Agreement have been inserted for convenience of reference only and shall not be deemed to be part of this Agreement.
10.4 Severability . If any provision hereof should be held invalid, illegal or unenforceable in any respect, then, to the fullest extent permitted by law, (a) all other provisions hereof shall remain in full force and effect and shall be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible and (b) the parties shall use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of such provision(s) in this Agreement.
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10.5 Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware as applied to contracts entered into and performed entirely in the State of Delaware by Delaware residents, without regard to conflicts of law principles.
10.6 Counterparts . This Agreement may be executed in two or more counterparts (including by facsimile, PDF, or other means of electronic communication), each of which shall constitute an original, but all of which, when taken together, shall constitute but one instrument, and shall become effective when one or more counterparts have been signed by each party hereto and delivered to the other parties.
10.7 Successors and Assigns . Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties hereto, provided that Intrexon shall not assign its rights or obligations hereunder unless Intrexon assigns such rights in whole and not in part to an assignee of such rights and obligations which shall agree in writing with the Company to be bound by this Agreement.
10.8 No Third Party Beneficiaries . This Agreement is intended for the benefit of the parties hereto and their respective permitted successors and assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other person.
10.9 Entire Agreement . This Agreement, the Amendment, the Channel Agreement, the Rights Agreement and other documents executed and delivered pursuant hereto and thereto, including the exhibits, constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and thereof.
10.10 Publicity . Except as otherwise provided herein or in the Channel Agreement, no party shall issue any press releases or otherwise make any public statement with respect to the transactions contemplated by this Agreement without the prior written consent of the other party, except as may be required by applicable law or regulations, in which case such party shall provide the other parties with reasonable notice of such publicity and/or opportunity to review such disclosure.
10.11 Waiver of Rule of Construction . Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
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I N W ITNESS W HEREOF , the parties hereto have caused this Supplemental Stock Issuance Agreement to be executed by their duly authorized representatives as of the day and year first above written.
FIBROCELL SCIENCE, INC. | ||
By: | /s/ David Pernock | |
Name: David Pernock | ||
Title: CEO |
INTREXON CORPORATION | ||
By: | /s/ Gregory Frost | |
Name: Gregory Frost | ||
Title: SVP Health Sector |
SIGNATURE PAGE FOR SUPPLEMENTAL STOCK ISSUANCE AGREEMENT
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Exhibit 99.1
Fibrocell Science and Intrexon Expand Collaboration
to Include Hypermobility-Type Ehlers-Danlos Syndrome
Growing Pipeline of Protein Replacement Therapies for Rare Connective Tissue Disorders
Exton, PA and Germantown, MD, Jan. 13, 2014 Fibrocell Science, Inc . (NYSE MKT:FCSC), an autologous cell therapy company primarily focused on developing first-in-class treatments for skin diseases and conditions with high unmet medical needs, and Intrexon Corporation (NYSE: XON), a leader in synthetic biology, announced today an expansion of their Exclusive Channel Collaboration (ECC) to develop a treatment for Ehlers-Danlos syndrome hypermobility type (EDS-HT), a rare genetic disorder resulting in weakened connective tissue.
Fibrocell and Intrexon will endeavor to engineer autologous fibroblast cells genetically corrected to produce tenascin-X (TN-X), a protein that is deficient in the connective tissue of a subset of EDS-HT patients. Patients with EDS-HT often experience significant musculoskeletal complications, including frequent joint dislocations, subluxations and early onset osteoarthritis.
Jouni Uitto, M.D., Ph.D., Chair of the Department of Dermatology and Cutaneous Biology at Thomas Jefferson University in Philadelphia, Pennsylvania, said the collaboration is a step toward addressing the unmet needs of EDS patients around the world.
There are currently no therapies for hypermobility-type EDS, said Dr. Uitto. Healthcare providers are only able to treat the severe symptoms of EDS, such as prescribing braces to improve joint stability and by assisting patients with the pain they experience. The prospect of an actual treatment is wonderful news for these patients.
Fibrocell Chief Executive Officer David Pernock noted that the companies evolving expertise and experience gained through the existing RDEB collaboration will be leveraged to accelerate EDS therapy research and development.
Intrexon and Fibrocell have unique experience in protein replacement therapy using autologous fibroblasts as a delivery mechanism, said David Pernock, Fibrocell Science Chief Executive Officer. Intrexons UltraVector ® technology has made it possible for Fibrocell to leverage the power of its autologous fibroblasts to address a host of unmet medical needs.
Using Fibrocells autologous fibroblast technology platform and Intrexons UltraVector ® platform, the companies plan to genetically modify autologous fibroblasts to express TN-X. The goal is to employ the TN-X-expressing cells in the clinic, where they would be injected into EDS-HT patients at the disease sites most likely lower limbs like knees, hips and feet, as well as the jaw to correct connective tissue malfunction caused by deficient TN-X expression. Fibrocells technology led to the FDA-approved cell based autologous fibroblast product, azficel-T (LAVIV ® ).
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Fibrocell is unique in that it has identified, fostered and developed a unique method of harvesting and expanding human autologous fibroblasts ex vivo , said Samuel Broder, M.D., Chairman of Intrexons Health Sector and former Director of the National Cancer Institute.
We see vast potential for additional disease targets as we grow our collaborative relationship with Fibrocell. Through our collaborations our goal is to develop wholly new classes of therapeutics for the treatment of multiple skin disorders with unmet medical needs that potentially affect millions worldwide, Dr. Broder said.
Under terms of the expanded agreement, Intrexon will receive a technology access fee of $5 million in Fibrocell common stock valued at the closing price on January 9, 2014 of $4.88. Other aspects of the agreement duplicate the terms related to the existing collaboration pertaining to RDEB and the new class of therapeutics the companies are developing for morphea , cutaneous eosinophilias , and psoriasis .
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (NYSE MKT:FCSC) is an autologous cell therapy company primarily focused on developing first-in-class treatments for skin diseases and conditions with high unmet medical needs. Based on its proprietary autologous fibroblast technology, Fibrocell is pursuing breakthrough medical applications of azficel-T for restrictive burn scarring and vocal cord scarring. The companys collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology, includes using genetically-modified fibroblasts for treating orphan skin diseases for which there are no currently approved products and exploring the localized treatment of the most common autoimmune skin disease, moderate-to-severe psoriasis. Fibrocells collaboration with UCLAfocusing on skin-derived stem cells and more efficient ways to convert skin cells to other cell typesholds potential for future discovery and development of autologous cellular therapeutics. For additional information, visit www.fibrocellscience.com .
About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is a leader in synthetic biology focused on collaborating with companies in Health, Food, Energy and the Environment to create biologically-based products that improve the quality of life and the health of the planet. Through the companys proprietary UltraVector ® platform, Intrexon provides its partners with industrial-scale design and development of complex biological systems. The UltraVector ® platform delivers unprecedented control over the quality, function, and performance of living cells. We call our synthetic biology approach and integrated technologies Better DNA ® , and we invite you to discover more www.DNA.com .
About UltraVector ®
UltraVector ® is one of Intrexons proprietary technology platforms for the design, creation, modification, and regulation of complex gene programs and cellular systems at commercial scale.
Trademarks
Intrexon, UltraVector, and Better DNA are trademarks of Intrexon and/or its affiliates. Other names may be trademarks of their respective owners.
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Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. Forward-looking statements include, without limitation, the ability of Fibrocell and Intrexon to engineer autologous fibroblast cells genetically corrected to produce TN-X and to develop wholly new classes of therapeutics for the treatment of skin disorders with unmet medical needs. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results.
###
For more information, contact:
Fibrocell Contact:
Greg Weaver
Chief Financial Officer
Tel: +1 (484) 713-6000
gweaver@fibrocellscience.com
Intrexon Corporation Contact:
Marie Rossi, Ph.D.
Manager, Technical Communications
Tel: +1 (301) 556-9944
publicrelations@intrexon.com
Page 3 of 3
Fibrocell
Corporate Presentation
January 2014
Exhibit 99.2
|
2
Forward Looking Statement
This
presentation
includes
statements
that
are
forward-looking
statements.
Forward-looking
statements
include, without limitation, our ability (i) to timely enroll, commence and successfully
complete our clinical
programs, (ii) to successfully genetically modify the
fibroblast
cell to treat patients who have collagen
deficient diseases, (iii) to successfully and cost-effectively leverage our collaboration
with Intrexon
Corporation to develop new product candidates, (iv) to successfully
leverage our relationships with UCLA
and MIT to develop new applications, and (v) to
adopt technologies that will dramatically reduce
manufacturing time, complexity, and
labor costs for our cell therapies. While management has based any
forward-looking
statements contained in the presentation on its current expectations, the information on
which such expectations were based may change. These forward-looking statements rely on a
number of
assumptions
concerning
future
events
and
are
subject
to
a
number
of
risks,
uncertainties,
and
other
factors,
many of which are outside of Fibrocell Sciences control, that could cause actual results
to materially differ
from such statements. Such risks, uncertainties, and other factors
include, but are not necessarily limited to,
those set forth under the caption
Item 1A. Risk Factors
in Fibrocell Sciences most recent Form 10-K
filing,
as updated in Item 1A. Risk Factors
in Fibrocell Sciences most recent Form 10-Q filing. In addition,
Fibrocell Science operates in a highly competitive and rapidly changing environment, and new
risks may
arise. Accordingly, you should not place any reliance on forward-looking
statements as a prediction of actual
results. Fibrocell Science disclaims any intention
to, and undertakes no obligation to, update or revise any
forward-looking
statement. You are also urged to carefully review and consider the various disclosures in
Fibrocell Sciences most recent annual report on Form 10-K, our most recent Form
10-Q as well as other
public filings with the SEC since the filing of Fibrocell
Sciences most recent annual report.
|
NYSE MKT: FCSC
Market Cap: ~$190 million as of 1/9/2014
Ownership: ~70% institutional, significant investment by Randal J. Kirk affiliates
HQ facility: Exton, PA
~60 employees
Management Team
development, manufacturing and commercial experience
David Pernock, Chairman of the Board, President & CEO
Previously SVP at GlaxoSmithKline
Greg Weaver, CFO
Previously CFO at Celsion, Poniard, Sirna, ILEX, Nastech, Talyst
Robert Sheroff , VP of Technical Operations
Previously SVP at Biogen Idec, VP at J&J, Centocor, Warner Lambert
John Maslowski, VP of Scientific Affairs
Previously at Wyeth Pharmaceuticals
Laura Campbell, VP of HR & Business Process
Previously at GlaxoSmithKline
Corporate Profile
3
|
Investment
Highlights
2 clinical stage development sBLA programs: azficel-T to treat
restrictive burn scarring and vocal cord scarring
Based on proprietary, autologous fibroblast platform technology
Phase II top-line results anticipated Q1 2015
Strategic collaboration with Intrexon Corporation (NYSE: XON)
Focused on genetically-modified autologous fibroblast cells
Multiple orphan skin and connective tissue disease indications in late stage pre-
clinical
Strong IP on proprietary technology platform and manufacturing
process issued through 2031
Approved BLA for azficel-T means sBLAs for follow-on indications
Proof of concept and FDA validation
Demonstrated ability to manufacture autologous therapy across product candidates
~$64 million cash position as of October 2013 with no debt
4
|
Most common cells in
connective tissue, which
produce collagen and
extracellular matrix proteins
Ideal delivery vehicle to
treat skin and connective
tissue diseases locally, not
systemically, with
genetically modified
fibroblast cells
Autologous Fibroblast Cells
5
|
Fibrocell
Leadership:
Proprietary technology to address unmet needs
The scientific leader in autologous fibroblasts, the most common
cells in connective tissue
Ideal to deliver genes to a localized area
Autologous cells eliminate risk of patient rejection
Unique expertise in collection and cultivation of fibroblasts
Proprietary autologous fibroblast cell technology used to create
personalized biologics derived from a patients own cells to treat
rare and serious skin and connective tissue diseases
Fibroblast therapeutics offer significant promise to treat
diseases with limited or no options
Unmet
medical
needs
in
well
defined
patient
populations
Restrictive Burn Scarring & Vocal Cord Scarring
Orphan
indications
with
streamlined
path
to
approval
genetically
modified autologous fibroblast therapies offer advantages: no
lentivirus transfection, no systemic drug delivery
6
|
Strategic Focus:
Leveraging the Potential
of Our Autologous Fibroblast Platform
Restrictive Burn Scarring
Vocal Cord Scarring
Recessive Dystrophic
Epidermolysis Bullosa (RDEB)
Morphea Scleroderma
Cutaneous Eosinophilic Fasciitis
7
|
NEW ECC:
Tenascin-X Deficiency
NEW ECC with Intrexon signed January 10, 2014
Tenascin-X is an extracellular matrix glycoprotein found in loose
connective tissue
Believed that tenascin-X helps determine how collagen fibrils are
deposited in the extracellular matrix of joints, organs, and skin,
regulating the structure and stability of elastic fibers
Mutation in the gene reduces the level of tenascin-X, leading to
disorganization of these connective fibers in skin, ligaments and
tendons
The fibroblast serves the role as being the delivery mechanism
delivering the gene(s), which potentially correct the diseased gene
conditions, to the localized target area, a novel approach.
8
|
Indication
2H2013
1H2014
2H2014
1H2015
2H2015
1H2016
2H2016
RBS (azficel-T)
VCS (azficel-T)
RDEB
Orphan
Morphea
Orphan
(Linear Scleroderma)
Cutaneous
Eosinophilic Fasciitis
Orphan
Tenascin-X
Orphan
GM BMP2
(Potential
Major Partnership)
Phase II Primary Endpoint
Phase II Primary Endpoint
Product Optimization and PoC Studies; Pre-Clinical
Phase III
Phase III
BLA
Phase I
Phase I
Phase II/III
9
Phase I
Product Optimization and PoC Studies/Pre-Clinical
Product Optimization and PoC Studies/Pre-Clinical
Product Optimization and PoC Studies/Pre-Clinical
Development Pipeline
PoC Studies/Pre-Clinical/Funded by CIRM Grants
Phase I
BLA
|
10
Azficel-T Label Extension Opportunities
|
Importance of
BLA for azficel-T
Label Expansion
higher value opportunities near term
Not starting from scratch
2 clinical stage development programs
Phase II Restrictive Burn Scarring
Phase II Vocal Cord Scarring
Demonstrated ability to manufacture autologous therapy across
product candidates
BLA approved
11
|
12
Scarring: azficel-T Label Extensions
Fibrocell Scarring Pipeline:
Addressable Market Opportunity
Restrictive Burn Scarring (U.S. only)
-
40,000 hospitalized burn victims in 2012
(1)
-
Total excludes military burn injuries
-
Addressable Patient Population:
-
25% treated
(2)
-
Pool of patients available includes
previous 3 years
-
Current treatment options include
surgery, physical therapy
(1)
American Burn Association
http://www.ameriburn.org/
(2)
Fibrocell internal estimates
(3)
Fibrocell estimates based on current pricing and estimated average volumes of azficel-T
used to treat patients with these conditions; prices are subject to change and variation
(4)
Cohen, (2010); Dailey et al. (2007); Roy et al. (2005); Poels et
al. (2003); Koufman and Isaacson (1991); Painter (1990); Bouchayer et al. (1985); Laguaite
(1972)
(5)
Acne Resource Center.
www.acne
-
resource.org
Vocal Cord Scarring (U.S. only)
-
200,000-700,000 patients with VCS
(4)
-
Current treatment options limited to surgery
and voice therapy
|
Restrictive Burn
Scarring Overview
13
(1)
www.ameriburn.org; Goodis. J and E.d. Schraga. Burns, thermal. eMedicine
Journal
(2)
American Burn Association. National Burn Repository®. 2012 Report. Dataset Version 8.0.
Data collected from reporting burn facilities over a ten year
period (Jan 2002
Jan 2011). Patient total: 140,009.
Opportunity is to treat mobility limitations created by burn scar
tissue
Typically at the shoulder, elbow, wrist, knee
No FDA approved therapeutics, unmet medical need is significant
Current therapies include surgery option
40,000 or more yearly hospitalizations for severe burns
(1)
Focused market opportunity: 60% of cases treated at 127 U.S.
burn centers
Extent of burn injury: 90% of burn patients experience burns on
< 20% of TBSA
(2)
|
Pre-Treatment
12 Mo Post-Treatment
Full range-clench
14 Mo Post-Treatment
Fine finger movement
Six Months Post Treatment
(2)
:
Full range of neck rotation, and pain free
Patient has stopped all analgesics
Discarded cervical collar
(1)
(1)
Inglefield,
C.
BSc,
FRCS(Plast).
An
Open-label
Case
Experience
with
Autologous
Fibroblast
Therapy
(AT)
in
the
Management
of
Burn
Scars,
Poster Presented at AAD Jan 2008.
(2)
Case Study Photographs, Courtesy of Chris Inglefield.
Restrictive Burn Scarring
Results from Open-Label Case Studies
14
Before
After
|
Double-blind, randomized, placebo-controlled, 21 subjects (up to 30)
Subjects inclusion criteria:
Unilateral restrictive burn scars of a jointed area
20-60% restriction in normal range of motion
FDA Agreed-upon Validated Measurement Scales:
Range of Motion Measurement
1
Brief Pain Index (BPI)
2
Scar Appearance
Vancouver Scar Scale
3
7 trial sites initiated and patient screening began in 2013
First patient on study Q1 2014
Top-line results expected Q1 2015
1.
Standard ROM measuring techniques (Parry, et al 2010)
2.
Brief Pain Inventory (BPI) numerical scale (0 to 10) (Cleeland and Ryan 1994; Tan, et al
2004).
3.
Vancouver Scar Scale (Baryza and Baryza 1995; Nedelec, et al 2000)
Restrictive Burn Scarring Phase II
15
|
Positive
pilot
study
results
published
in
peer-reviewed
journal
The
La
ryngoscope
,
2011
(1)
Azficel-T well-tolerated when injected into vocal folds; n=5
Improvements lasted up to one year
Findings supported by mucosal wave grade, voice handicap index, and voice
quality questionnaire
(1)
Chhetri, Dinesh, Injection of Cultured Autologous Fibroblasts for Human Vocal Fold Scars.
The Laryngoscope
121(4) : 785-792, 2011.
Vocal Cord Scarring Overview
16
No FDA approved therapeutics
Most commonly encountered finding
is loss of voice
Due to surgery, radiation therapy, vocal
cord trauma and idiopathic causes
200,000-700,000 current prevalence;
treatment options include surgery, voice
therapy
|
Trial initiated 2H 2013
Double-blind, randomized, placebo-controlled, 20 subjects (up to 30)
4 month efficacy endpoint: Top-line data expected Q1 2015
Subject inclusion criteria
:
Presence of unilateral or bilateral vocal fold scarring or age-related dysphonia
Failed other voice treatments including, but not limited to, anti-reflux regimen,
speech therapy, or vocal fold injection augmentation
Feels their voice quality is a major handicap
FDA Agreed-upon Validated Study Endpoints:
Absolute change from baseline in mucosal wave grade using videostroboscopy
Absolute and % change from baseline in the Voice Handicap Index (VHI)
1
Vocal Cord Scarring Phase II
17
1.
Jacobson BH, Johnson A, Grywalski A et al. The Voice Handicap Index: Development and
validation.
J Voice
1998;12:540-50.
2.
Karnell MP, Melton SD, Childes JM et al. Reliability of clinician-based (GRBAS and
CAPE-V) and patient-based (V-RQOL and IPVI) documentation of voice disorders.
J Voice
2007;21:576-90
.
|
Intrexon
Collaboration
Incorporating Intrexons Synthetic
Biology
to Expand
Fibrocells Fibroblast Platform
18
|
The Power of the
Intrexon Collaboration
Autologous Fibroblast Expertise
Synthetic Biology Platform
19
|
Multiple orphan disease indications
Genetically-Modified (GM) autologous fibroblasts with therapeutic gene(s) of
interest for the
localized treatment of skin and connective tissue diseases
(non
-
systemic),
addressing
the
underlying
cause
of
these
diseases
and
providing
relief
of
symptoms
Advantages
-
Targeting
therapeutic
at
lesion
site
a
more
responsive
approach
-
Reduce rejection concern; provide more controlled delivery
-
Non-integrating plasmids may reduce safety issues
Intrexon Collaboration Highlights
20
|
Intrexon
RheoSwitch Therapeutic
System®: Key for Autoimmune Diseases
Intrexon Corp. proprietary on/off biologic switch, incorporated into an
UltraVector®
designed vector
Three-component transcriptional regulator that provides inducible gene
expression
Maintains gene program in inactive state until patient takes a pill or topically applies
a compound containing a small molecule ligand
Ability to not only express proteins/enzymes, but also ability to control level and
timing of expression
Demonstrated highly controllable expression both
in vivo
and
ex vivo
©
2013 Intrexon Corp. All rights reserved.
21
|
Orphan Skin
Diseases:
Large Unmet Market Opportunities
Recessive Dystrophic
Epidermolysis Bullosa
(RDEB)
$560 million-$2.2 billion:
(5,6,7,8)
Morphea Scleroderma
$300-$350 million:
(3,4)
Cutaneous Eosinophilic
Fasciitis
$120-$140 million:
(1,2)
22
References
See Appendix on Slide 28
|
RDEB characterized primarily by the
formation of blisters over widespread
areas of the body, resulting from a
mutation in the COL7A1 gene which
encodes for type VII collagen
the
main component of connective and
fibrous tissues
A genetically-modified (GM)
fibroblast upregulated to produce
Collagen VII in a controlled manner
for localized treatment
Autologous dermal fibroblast
transfected with a non-integrating
plasmid vector containing the gene
for COL7A1
RDEB: Unique Approach to Localized
Treatment of Rare Skin Disease
23
Localized treatment using the autologous
fibroblast as delivery vehicle for multiple gene
targets -
Reducing the underlying cause
plus
providing symptom relief on the skins surface
|
Autoimmune Skin
Diseases
Localized Treatment
24
Rare and serious orphan autoimmune diseases that
manifest on the skin
Morphea Scleroderma
Underlying cause is accumulation of collagen
Cutaneous Eosinophilic Fasciitis
Underlying cause of inflammation is accumulation of
eosinophils
Treatment localized to the affected site is preferred
for patient so not to impact the immune system as a
whole, creating new health issues
Proposed drug candidates:
Genetically-modified fibroblast using vector designed
with a gene controlled by Intrexons RheoSwitch
Therapeutic System®
(RTS®) Technology
Topical activator directed at target site allows for
localized vs. systemic treatment
|
Financials
25
|
Cash position ~$64 million following October 2013 financing
$50.5 million gross proceeds from underwritten offering
-
Led by Barclays, co-managers Wedbush and Griffin
Quarterly average use of cash: $6-7 million
39.8 million shares outstanding
-
6.0 million warrants o/s; 1.3 million options o/s
Clean capital structure
Analyst research: Ying Huang-Barclays; Greg Wade-Wedbush; Keith
Markey-Griffin
Financial Information
26
|
2014 Key
Milestones
27
Milestone
Timing
Restrictive Burn Scarring
Phase II Enrollment Complete
Q2 2014
Vocal Cord Scarring
Phase II Enrollment Complete
Q2 2014
RDEB
Proof of Concept & IND Completed
End of 2014
Key Publications:
BMP2
Genomic Stability
Skin-Derived Mesenchymal Skin Cells
2H 2014
Apply for Orphan Drug Status for up to 5
separate disease indications
2H 2014
|
Milestone
Timing
Restrictive Burn Scarring
Phase II Top-line Results
Q1 2015
Vocal Cord Scarring
Phase II Top-line Results
Q1 2015
RDEB
Phase I
1H 2015
Restrictive Burn Scarring
Phase II Complete
1H 2015
Vocal Cord Scarring
Phase II Complete
1H 2015
Morphea/Linear Scleroderma
Proof of Concept & IND Completed
2H 2015
Cutaneous Eosinophilic Fasciitis
Proof of Concept & IND Completed
2H 2015
2015 Key Milestones
28
|
Key Scientific
& Clinical Advisors
29
Institution
Focus
Dr. Robert Langer
MIT, David Koch Institute Professor; Harvard-MIT Division of
Health Sciences & Technology, Faculty
Chief Scientific Advisor
Dr. Dinish Chhetri
UCLA, Associate Professor, Department of Head and Neck
Surgery; UCLA School of Medicine
Vocal Cord Scarring
Dr. Dan Lozano
Lehigh Valley (PA) Health Network, Chief, Department of
Surgery-Division of Burn; Surgical Specialists of the Lehigh
Valley-Burn; Medical Director, Regional Burn Center
Restrictive Burn Scarring
Dr. Anne Lucky
Cincinnati Childrens Hospital Medical Center, Co-director of
the Epidermolysis Bullosa Center; Member of the Hemangioma
and Vascular Malformation Center
Recessive Dystrophic
Epidermolysis Bullosa (RDEB)
Dr. Dan Anderson
MIT, Associate Professor, Departments of Chemical
Engineering, Division of Health Sciences and Technology,
member of the David Koch Institute for Integrative Cancer
Research
Skin-derived Induced
Pluripotent Stem Cells (iPSCs);
Skin-derived Mesenchymal
Stem Cells (MSCs)
Dr. James Byrne
UCLA, Assistant Professor, Department of Molecular and
Medical Pharmacology and the Broad Stem Cell Research
Center
Skin-derived Induced
Pluripotent Stem Cells (iPSCs);
Skin-derived Mesenchymal
Stem Cells (MSCs)
|
Investment
Highlights
2 clinical stage development sBLA programs: azficel-T to treat
restrictive burn scarring and vocal cord scarring
Based on proprietary, autologous fibroblast platform technology
Phase II top-line results anticipated Q1 2015
Strategic collaboration with Intrexon Corporation (NYSE: XON)
Focused on genetically-modified autologous fibroblast cells
Multiple orphan skin and connective tissue disease indications in late stage pre-
clinical
Strong IP on proprietary technology platform and manufacturing
process issued through 2031
Approved BLA for azficel-T means sBLAs for follow-on indications
Proof of concept and FDA validation
Demonstrated ability to manufacture autologous therapy across product candidates
~$64 million cash position as of October 2013 with no debt
30
|
Appendix
References
Slide 21
Orphan Skin Diseases
(1)
Cutaneous eosinophilias represent a family of more than 30 different conditions ranging from
eosinophilic cellulitis (Wells
syndrome)
to eosinophilic dermatosis and eosinophilic fasciitis. The prevalence varies based on
which conditions are targeted for treatment. It
could be as low as a few hundred
patients (Wells
syndrome and eosinophilic fasciitis) to thousands of patients
(Duhring disease, which
affects 15% to 25% of celiac patients). We chose 4,000
patients
based on the Fibrocell press release dated July 1, 2013.
(2)
Beyer et al. Recent Trends in Systemic Psoriasis Treatment Costs
Arch Dermatol 2010;146(1):46-54. We assume that the cutaneous
eosinophilias indication will command a higher price than the psoriasis indication due to the
need for new treatment options, the
frequency of treatment, and the severity of the
condition.
(3)
Kaplan et al. Localized Fibrosing Disorders
Linear Scleroderma, Morphea, and Regional Fibrosis
eMedicine
March 6, 2013.
(4)
Beyer
et
al.
Recent
Trends
in
Systemic
Psoriasis
Treatment
Costs
Arch
Dermatol
2010;146(1):46-54.
We
assume
that
the
morphea
indication will command a higher price than the psoriasis indication due to the need for new
treatment options, the frequency of
treatment, and the severity of the condition.
(5)
Stanford School of Medicine, Epidermolysis Bullosa Clinic Frequently Asked
Questions
Available at:
http://dermatology.stanford.edu/gsdc/eb_clinic/eb-faqs.html
. Accessed July 11, 2013.
(6)
The Dystrophic Epidermolysis Bullosa Research Association of America (DEBRA), About
EB
http://www.debra.org/abouteb
. Accessed
July 11,
2013.
(7)
Herper, Matthew. How A $440,000 Drug Is Turning Alexion Into Biotechs New
Innovation Powerhouse.
Forbes.
5 September 2012
(8)
The price range represents the price potential for a new therapy
for a severe ultra rare disease based on currently marketed rare
disease therapies such as Soliris®
(eculizumab -
~$400,000/year), Elaprase®
(idursulfase -
~$375,000/year), Naglazyme®
(galsulfase -
~$365,000/year), Myozyme®
(alglucosidasealfa -
~$300,000/year), and Fabrazyme®
(agalsidase beta -
~$200,000/year).
31
|