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): December 5, 2013

 

Synthetic Biologics, Inc.

(Exact name of registrant as specified in charter)

 

Nevada

(State or other jurisdiction of incorporation)

 

01-12584 13-3808303
(Commission File Number) (IRS Employer Identification No.)

 

155 Gibbs Street, Ste. 412

Rockville, MD 20850

 

 

 (Address of principal executive offices and zip code)

 

(734) 332-7800

 (Registrant’s telephone number including area code)

 

N/A

(Former Name and Former Address)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of 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(b) 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 December 5, 2013, Synthetic Biologics, Inc. (the “Company”), through its newly formed, majority owned subsidiary, Synthetic Biomics, Inc. (“SYN Biomics”), entered into a worldwide exclusive license agreement (the “License Agreement”) and option agreement (the “Option Agreement”) with Cedars-Sinai Medical Center (“CSMC”) for the right to develop, manufacture, use, and sell products for the human and veterinary therapeutic and prophylactic treatments for acute and chronic diseases discovered by an investigational team led by Mark Pimentel, M.D. at CSMC to be associated with pathogenic gastrointestinal microorganisms, including for example, irritable bowel syndrome (IBS), obesity and type 2 diabetes. The portfolio of intellectual property licensed to SYN Biomics under the License Agreement includes nine issued U.S. patents, one issued European patent validated in 18 countries, one issued European patent validated in three countries, two issued Australian patents, and one issued Japanese patent as well as 13 pending U.S. and international patent applications for most fields of use and modalities (subject to certain agreed-upon exceptions); two pending U.S. patent applications are optioned to SYN Biomics under the Option Agreement.

 

The License Agreement provides that the Company will issue to CSMC 291,569 unregistered shares of Company common stock, subject to approval by the NYSE MKT, LLC, or in the event such shares are not issued within 30 days, pay to CSMC in the form of cash, an initial license fee and patent reimbursement fee of $150,000 and $220,000, respectively. The parties also entered into a Stock Purchase Agreement with respect to such stock issuance and other issuances of unregistered shares of Company common stock that may be issued to CSMC in lieu of cash, including license fees, milestone payments, expense reimbursements and option fees under the License Agreement or Option Agreement. Any and all such stock issuances by the Company shall be subject to the prior approval of the NYSE MKT, LLC. The License Agreement also provides that commencing on the second anniversary of the License Agreement, SYN Biomics will pay an annual maintenance fee, which payment shall be creditable against annual royalty payments owed under the License Agreement. In addition to royalty payments which are a percentage of Net Sales (as defined in the License Agreement) of Licensed Products (as defined in the License Agreement) and Licensed Technology products (as defined in the License Agreement), SYN Biomics is obligated to pay CMSC a percentage of any non-royalty sublicense revenues, as well as additional consideration upon the achievement of the following milestones (the first two of which are payable in cash or unregistered shares of Company stock at the Company’s option): (i) successful Phase I trial completion of the first Licensed Product or first Licensed Technology Product; (ii) successful Phase II trial completion of the first Licensed Product or first Licensed Technology Product; (iii) initiation of Phase III dosing for each additional indication of a Licensed Product or Licensed Technology Product; (iv) successful Phase III trial completion for each Licensed Product and each Licensed Technology Product; (v) the U.S. Food and Drug Administration’s (“FDA”) acceptance of a New Drug Application for each Licensed Product and each Licensed Technology Product; (vi) regulatory approval for each Licensed Product and each Licensed Technology Product; and (vii) the first commercial sale of each Licensed Product and each Licensed Technology Product. The stock issuances are subject to prior approval of the NYSE MKT, LLC.

 

Prior to the execution of the License Agreement, SYN Biomics issued shares of common stock of SYN Biomics to each of CSMC and Mark Pimentel, M.D. (the primary inventor of the intellectual property), representing 11.5% and 8.5%, respectively, of the outstanding shares of SYN Biomics (the “SYN Biomics Shares”). The Stock Purchase Agreements for the SYN Biomics Shares provide for certain anti-dilution protection until such time as an aggregate of $3,000,000 in proceeds from equity financings are received by SYN Biomics as well as a right, under certain circumstances in the event that the SYN Biomics Shares are not then freely tradeable, and subject to NYSE MKT, LLC approval, as of the 18 and 36 month anniversary date of the effective date of the Stock Purchase Agreements, for each of CSMC and the Mark Pimentel to exchange up to 50% of their SYN Biomics shares for unregistered shares of the Company’s common stock, with the rate of exchange based upon the relative contribution of the valuation of SYN Biomics to the public market valuation of the Company at the time of each exchange. The Stock Purchase Agreements also provide for tag- along rights in the event of the sale by the Company of its shares of SYN Biomics.

 

The License Agreement terminates: (i) automatically if SYN Biomics enters into a liquidating bankruptcy or other specified bankruptcy event or if the performance of any term, covenant, condition or provision of the License Agreement will jeopardize the licensure of CMSC, its participation in certain reimbursement programs, its full accreditation by the Joint Commission of Accreditation of Healthcare Organizations or any similar state organizations, its tax exempt status or is deemed illegal; (ii) upon 30 days notice from CMSC if SYN Biomics fails to make a payment or use commercially reasonable efforts to exploit the patent rights; (iii) upon 60 days notice from CMSC if SYN Biomics fails to cure any breach or default of any material obligations under the License Agreement; or (iv) upon 90 days notice from SYN Biomics if CMCS fails to cure any breach or default of any material obligations under the License Agreement. SYN Biomics also has the right to terminate the License Agreement without cause upon 6 months notice to CSMC; however, upon such termination, SYN Biomics is obligated to pay a termination fee with the amount of such fee reduced: (i) if such termination occurs after an Investigational New Drug submission to the FDA but prior to completion of a Phase II clinical trial, (ii) reduced further if such termination occurs after completion of Phase II clinical trial but prior to completion of a Phase II clinical trial; and (iii) reduced to zero if such termination occurs after completion of a Phase III clinical trial.

 

 
 

 

Pursuant to the terms of the Option Agreement, SYN Biomics has a period of six months to negotiate an exclusive license to develop, manufacture, use, and sell biologic products relating to the prevention, acute treatment and chronic treatment of irritable bowel syndrome or other indications utilized or derived from certain optioned patent applications, pending completion of certain limited testing of technology embodied in the patent applications. The Option Agreement provides that, within 30 days of the execution of the Option Agreement, the Company is obligated to pay to CSMC a non-refundable option fee of 43,342 shares of unregistered Company stock, or $50,000 cash in the event such issuance is not approved by NYSE MKT, LLC. In addition, SYN Biomics has the right to extend the option period for an additional six months, for an additional non–refundable extension fee of $25,000, payable in unregistered shares of the Company’s common stock having a market value of 110% of such amount, subject to approval of NYSE MKT, LLC, or in cash. At any time during the 6 or 12 month option period (if so extended) SYN Biomics has the right to exercise the option and negotiate an exclusive license to the optioned patent applications, which shall provide for: (i) a $50,000 license issue fee plus reimbursement of patent expenses incurred by CSMC prior to the exclusive license, payable to CSMC in unregistered shares of Company stock having a market value of 110% of such amount, subject to approval of the NYSE MKT, LLC, or in cash, (ii) the same milestone payments, royalties and sublicense fees as are payable under the License Agreement dated December 5, 2013 for separately licensed intellectual property, and (iii) such other customary terms and conditions CSMC typically includes in its license agreements.

 

In collaboration with Intrexon Corporation, and partially utilizing the intellectual property optioned and/or licensed from CSMC described in the Option Agreement, SYN Biomics and the Company intend to develop biologic approaches for the prevention, acute and chronic treatment of a subset of irritable bowel syndrome (IBS) pathologies specifically caused by auto-antibodies. During the option period, SYN Biomics, the Company and Intrexon will seek to create and test a variety of biologic candidates for the treatment of a subset of IBS cases. This biologic program has been selected as the third target under the Company’s exclusive channel collaboration with Intrexon Corporation dated August 6, 2012.

 

The Company has appointed its founder and Licensing Associate, Steve H. Kanzer, CPA, JD, who was responsible for identifying and negotiating the CSMC transaction, to serve as CEO and President of the Company’s new SYN Biomics subsidiary, with Mr. Kanzer agreeing to increase his commitment of time from 50% to 80% with an increase in salary from $150,000 to $195,000 per annum. The foregoing description of the agreements does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, Option Agreement and the related Stock Purchase Agreements which are filed as Exhibits 10.1, 10.2, 10.3, 10.4 and 10.5 to this Current Report on Form 8-K and incorporated herein by reference.

 

On December 9, 2013, the Company issued the press releases attached hereto as Exhibits 99.1 and 99.2 regarding the agreements described herein.

 

Important Notice regarding the Agreement

 

The agreements have been included as an exhibits to this Current Report on Form 8-K to provide investors and security holders with information regarding its terms. They are not intended to provide any other financial information about the Company. The representations, warranties and covenants contained in the agreements were made only for purposes of those agreements and as of specific dates; were solely for the benefit of the parties to the agreements; may be subject to limitations agreed upon by the parties, including being qualified by disclosures made for the purposes of allocating contractual risk between the parties to the agreements instead of establishing these matters as facts; and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the Company. Moreover, information concerning the subject matter of the representations, warranties and covenants may change after the date of the agreements, which subsequent information may or may not be fully reflected in public disclosures by the Company.

 

 
 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits    

 

Exhibit No.   Description
     
10.1   Exclusive License Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc. and Cedars-Sinai Medical Center dated December 5, 2013**
10.2   Exclusive Option Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc. and Cedars-Sinai Medical Center dated December 5, 2013**
     
10.3   Stock Purchase Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc. and Cedars-Sinai Medical Center dated December 5, 2013
10.4   Stock Purchase Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc. and Mark Pimentel dated December 5, 2013
10.5   Stock Purchase Agreement between Synthetic Biologics, Inc., Synthetic Biomics, Inc. and Cedars-Sinai Medical Center dated December 5, 2013
99.1   Press Release dated December 9, 2013
99.2   Press Release dated December 9, 2013

 

**

Confidential treatment has been requested as to certain portions of this exhibit pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 

 

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.

 

Dated: December 10, 2013 SYNTHETIC BIOLOGICS, INC.
  (Registrant)
     
  By:   /s/ C. Evan Ballantyne
  Name: C. Evan Ballantyne
  Title: Chief Financial Officer

 

 

Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.  A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

EXCLUSIVE LICENSE AGREEMENT

 

THIS EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is entered into as of this 5 th day of December, 2013 (“Effective Date”) by and among CEDARS-SINAI MEDICAL CENTER, a California nonprofit public benefit corporation (“CSMC”), with offices at 8700 Beverly Boulevard, Los Angeles, California 90048-1865, SYNTHETIC BIOLOGICS, INC ., a Nevada corporation, with offices at 155 Gibbs Street, Suite 412, Rockville, Maryland 20850 (“Synthetic”), and SYNTHETIC BIOMICS, INC. , a Nevada corporation with offices at 155 Gibbs Street, Suite 412, Rockville, Maryland 2085 which is a majority-owned subsidiary of Synthetic (the “Licensee”).

 

RECITALS

 

A.            CSMC owns and/or is entitled to grant license rights with respect to certain Patent Rights and Technical Information (as defined below) invented or developed in connection with research performed at CSMC’s Gastrointestinal Motility Program and Laboratory and CSMC’s Division of Endocrinology, Diabetes and Metabolism under the direction of Mark Pimentel, M.D., Henry Lin, M.D., Christopher Chang, M.D., and Ruchi Mathur, M.D. (hereinafter collectively referred to as the “Inventors”).

 

B.            CSMC desires to have the Patent Rights and the Technical Information developed, used and commercialized in the Field of Use (as defined below) by Licensee, and Licensee desires to obtain an exclusive, worldwide license to conduct research in the Field of Use, and to develop, manufacture, use and sell Licensed Products and Licensed Technology Products (as defined below) in the Field of Use, using the Patent Rights and Technical Information in accordance with the terms of this Agreement. Other than the rights expressly granted by CSMC hereunder within the Field of Use, Licensee acknowledges that CSMC shall retain all other rights with respect to the Patent Rights and the Technical Information.

 

C.            CSMC and Licensee intend that the execution, delivery and performance of this Agreement by each party, and the consummation of the transactions contemplated hereunder, shall not at any time threaten CSMC’s tax-exempt status under Section 501(c)(3) of the Internal Revenue Code and Section 23701d of the California Revenue and Taxation Code, or cause CSMC to be in default under any of CSMC’s issued and outstanding tax-exempt bonds.

 

Now, Therefore , in consideration of the mutual covenants and premises herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

 

1.           Definitions

 

1.1           “Affiliate” or “Affiliates” shall mean any corporation, person or entity, which controls, is controlled by, or is under common control with, a party to this Agreement without regard to stock or other equity ownership. For purposes hereof, the terms “control” and “controls” mean the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a corporation, person or entity, whether through the ownership of voting securities, by contract or otherwise.

 

 
 

Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.  A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

1.2           “Confidential Information” shall mean any confidential or proprietary information furnished by one party (the “Disclosing Party”) to the other parties (the “Receiving Party”) in connection with this Agreement, including, without limitation, all specifications, know-how, trade secrets, technical information, drawings, software, models, business information and patent applications pertaining to the Patent Rights and Technical Information, and as further provided in Section 10 hereof.

 

1.3           “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereof.

 

1.4           “Field of Use” shall mean all human or veterinary therapeutic, prophylactic, diagnostic or prognostic applications, excluding the following:

 

1.          the therapeutic use of rifaximin;

 

2.          the therapeutic use of any of the following, as each is more fully described in U.S. Patent No. 6,558,708: (A) active lipids, (B) serotonin, serotonin agonists, or serotonin re-uptake inhibitors, (C) peptide YY or peptide YY functional analogs, (D) calcitonin gene-related peptide or functional analogs thereof, (E) adrenergic agonists, (F) opioid agonists, (G) combinations of any of (A), (B), (C), (D), (E) and/or (F); and (H) antagonists of receptors for any of (B), (C), (D), (E) and/or (F));

 

3.          the diagnosis, prognosis, or the testing of, or the provision of information to clinicians or patients regarding, small intestinal bacterial overgrowth (SIBO), and/or conditions or disorders related thereto in human subjects, using breath testing products or breath testing services to detect SIBO or SIBO-related conditions ( provided, however , that the right to include information about diagnostic testing described in the Patent Rights as inclusion, exclusion or similar criteria for regulatory purposes, including without limitation on prescribing labels shall not be excluded); and

 

4.          the diagnosis, prognosis, or the testing of, or the provision of information to clinicians or patients regarding, conditions, based on the analysis of anti-vinculin antibodies and/or anti-CDT (cytolethal distending toxins) antibodies.

 

1.5           “Funding Agencies” shall mean any public or private granting agencies which have provided funding to CSMC or to Dr. Pimentel for the development of any of the Patent Rights or Technical Information prior to the Effective Date.

 

1.6           “Improvements” shall mean all improvements or enhancements to the Patent Rights that, after the Effective Date, are conceived and reduced to practice if patentable, or reduced to practice if not patentable, by or under the direction of any of the Inventors at CSMC. For the avoidance of doubt, Improvements shall not include Sponsored Inventions (as defined in Section 2.4).

 

2
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

1.7           “Licensee Developments” shall mean any and all processes, uses, designs, applications, methods and compositions-of-matter, indications, improvements, enhancements and modifications in the Field of Use directly based upon or directly created using the Patent Rights and/or Technical Information and which were discovered or developed by or on behalf of Licensee (exclusive of work performed by CSMC or the Inventors) during the term of this Agreement.

 

1.8           “Licensed Product” or “Licensed Products” shall mean all therapeutic and prophylactic products and all diagnostic and/or prognostic products or services, in each case, the manufacture, use, offer for sale or sale of which would, but for the licenses granted in this Agreement, directly or indirectly infringe a Valid Claim of a Patent Right in the jurisdiction in the Territory where such product or service is manufactured, used, offered for sale or sold, and in each case, within the Field of Use.

 

1.9            Licensed Technology ” shall mean the clinical trial protocols, know-how, clinical trial results and data, developed and owned by CSMC relating to the Licensed Products, and in each case, within the Field of Use.

 

1.10          Licensed Technology Product ” shall mean a product or service made through the use of or incorporating Licensed Technology that is not otherwise a Licensed Product.

 

1.11         “Net Sales” shall mean the gross amount invoiced by Licensee or Permitted Sublicensees to third parties for all sales of Licensed Products or Licensed Technology Products less (a) trade, cash or quantity discounts or rebates actually allowed or taken; (b) credits for claims or allowances given or made for rejection of, or return of previously sold Licensed Products or Licensed Technology Products or retroactive price reductions (including Medicare and similar types of rebates); (c) charges for prepaid freight, insurance and other transportation costs directly related to the delivery of the Licensed Product or Licensed Technology Product and invoiced by Licensee or Permitted Sublicensees; and (d) sales, transfer and other excise taxes or other governmental charges actually paid in connection with sales of Licensed Products or Licensed Technology Products (but excluding what are commonly known as franchise, income taxes and value-added taxes). Sales of Licensed Products or Licensed Technology Products by Licensee, or a Permitted Sublicensee of Licensee, to any Permitted Sublicensee which is a reseller thereof shall be excluded, and only the subsequent sale of such Licensed Products or Licensed Technology Products by Permitted Sublicensees of Licensee shall be deemed Net Sales hereunder. If a Licensed Product or Licensed Technology Product is sold or provided as part of a system, package, or combination product or service that involve one or more products or services not covered by the Patent Rights (each, a “Combination Product”), Net Sales shall be calculated by multiplying the Net Sales of such Combination Product, by the fraction A/B, where “A” is the price of the Licensed Product or Licensed Technology Product included in such Combination Product when sold separately from any other products or services not covered by the Patent Rights and “B” is the price of the Combination Product. In the event that no market price is available for the Licensed Product or Licensed Technology Products included in such Combination Product when supplied or priced separately, CSMC and Licensee shall determine in good faith the fair market value thereof.

 

3
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

1.12         “Non-Royalty Sublicense Revenues” shall mean, but is not limited to, upfront fees, license maintenance fees, and milestone payments, or other payments, including the fair market value of any non-cash consideration, received by Licensee in consideration for any rights granted to Patent Rights under a sublicense agreement, including but not limited to upfront and milestone payments, license maintenance fees and the Fair Market Value of any non-cash consideration, excluding (a) sales-based royalties; and (b) reimbursements for customary patent expenses with respect to Patent Rights. As used in this Section 1.12, “ Fair Market Value ” means: (a) if the Permitted Sublicensee’s common stock is publicly traded on an exchange, the value of such equity using a per share price equal to the average of the reported closing prices of such stock on such exchange for the twenty (20) trading days prior to such purchase; or (b) if the Permitted Sublicensee’s common stock is not publicly traded, the value of such equity determined by the Permitted Sublicensee’s Board of Directors in good faith based on the per share purchase price of the Permitted Sublicensee’s most recent equity financing as of a date which is within thirty (30) days of the date as of which the determination is to be made.

 

1.13         “Patent Rights” shall mean the patents and/or patent applications existing on the Effective Date which are described on Schedule A attached hereto, and any patent that issues thereon. The Patent Rights are all owned by CSMC. The Licensed Patent Rights specifically exclude U.S. Patent Nos. 7,452,857, 7,605,240, 7,718,608, 7,935,799, 7,081,239, 7,244,412, 7,608,245, 7,615,207, 8,562,952, 6,558,708 and 5,977,175 and U.S. Patent Application Serial No. 11/411,733.

 

1.14         “Technical Information” shall mean, as of the Effective Date, the following information in the Field of Use which is described in the Patent Rights or otherwise provided to Licensee: know-how, trade secrets, unpublished patent applications, software, bioinformatics, unpatented technology, technical information, statistical information and analyses, biological materials, chemical reagents, preclinical and clinical information, in each case which has been conceived or reduced to practice prior to the Effective Date, in connection with research performed at CSMC’s Gastrointestinal Motility Program and Laboratory and CSMC’s Division of Endocrinology, Diabetes and Metabolism under the direction of one or any of the Inventors. The Technical Information shall further include information in the Field of Use described in Schedule B hereto and which has been reduced to practice prior to the Effective Date in the conduct of the aforementioned research programs at CSMC under the direction of one or any of the Inventors. Technical Information is all owned by CSMC.

 

1.15         “Territory” shall mean worldwide.

 

1.16         “Valid Claim” shall mean a claim of an issued patent included within the Patent Rights, which claim has not: (a) lapsed, been canceled, or become abandoned; (b) been declared invalid or unenforceable by a non-appealable decision or judgment of a court or other appropriate body or authority of competent jurisdiction; or (c) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise. The term Valid Claim shall also include the claims of a pending patent application within the Patent Rights.

 

4
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

2.           License

 

2.1           Grant of Exclusive Rights. Subject to the terms of this Agreement, CSMC hereby grants to Licensee, and Licensee hereby accepts from CSMC, the exclusive license, with the right to grant sublicenses (subject to the terms of Section 2.3 hereof), under and to the Patent Rights and Technical Information during the term of this Agreement (as provided in Section 6 hereof) to conduct research in the Field of Use and to make, have made, use, develop, import, have imported, export, have exported, offer for sale, or have offered for sale, sell and/or have sold Licensed Products and Licensed Technology Products in the Field of Use in the Territory. The foregoing grant of exclusivity is made expressly subject to the following:

 

(a)           All applicable laws and regulations, including, without limitation, the requirements of federal law as pertain to the manufacture of products within the United States;

 

(b)           All applicable rules of the Funding Agencies which have provided funding to CSMC or to any of its employees (including any of the Inventors) for the development of the Patent Rights and Technical Information; and

 

(c)           The following non-exclusive rights to the Patent Rights and Technical Information, which are retained by CSMC within the Field of Use:

 

(i)           the right to submit for publication the scientific findings from research conducted by or through CSMC or its investigators (including the Inventors) related to the Patent Rights and the Technical Information; and

 

(ii)          the right (A) to use any tangible or intangible information contained in the Patent Rights or the Technical Information or any Improvements (so long as CSMC shall treat such information as Confidential Information and maintain its confidentiality in accordance with Section 10 hereof), for CSMC’s internal non-commercial scientific, research, internal teaching, non-profit clinical research and other educationally-related and non-commercial (except for charges to its own patients) clinical purposes, where clinical use does not involve a third party funding grant to commercialize such information, and (B) to obtain research funding for further study and development thereof from governmental and other nonprofit organizations (including grant applications).

 

(d)           Notwithstanding any other provision hereof to the contrary, all rights to the Patent Rights, Technical Information and Improvements outside of the Field of Use are retained by CSMC. Furthermore, this Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of CSMC other than Patent Rights regardless of whether such patents are dominant or subordinate to Patent Rights.

 

2.2           Guarantee of Licensee’s Performance. Synthetic hereby unconditionally guarantees to CSMC the full and complete performance of all of the terms, covenants and conditions of this Agreement as required to be performed by Licensee, including, but not limited to, the payment of all amounts due hereunder. Synthetic’s guarantee obligations hereunder shall terminate on the later of (a) the date on which Licensee ceases to be controlled or majority-owned by Synthetic, whether alone or together with one or more of Synthetic’s Affiliates (other than Licensee); and (b) the date on which Licensee has paid CSMC the second milestone payment required by Section 4.6(e)(ii). For purposes of this Section 2.2, the term “control” means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of Licensee, whether through the ownership of voting securities, by contract or otherwise.

 

5
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

2.3           Sublicensing. Licensee shall have the right to grant sublicenses or to assign (subject to Section 13.11) any or all of the rights granted hereunder to (a) public companies listed on the NYSE, NYSE MKT, NYSE Arca or NASDAQ stock exchanges; (b) private companies having at least $25 million in annual sales; or (c) entities which have been approved in writing by CSMC (such consent not to be unreasonably withheld) (each, “Permitted Sublicensee”). Any such Permitted Sublicensee shall be subject in all respects to the provisions contained in this Agreement and Licensee will remain primarily liable to CSMC for, and shall be responsible for monitoring and enforcing, performance of all of Licensee’s obligations hereunder by any such Permitted Sublicensee. Without limiting the generality of the foregoing, as an express condition of any such sublicense, any such Permitted Sublicensee shall be required to agree in writing to be bound by commercially reasonable reporting and record keeping, indemnification and inspection provisions, and the applicable provisions of this Agreement, including, without limitation, those pertaining to the use of CSMC’s name and marks, indemnification of CSMC and the use of CSMC’s Confidential Information. Permitted Sublicensees may not further sublicense without CSMC’s prior written consent, which consent shall not be unreasonably withheld. Licensee shall promptly forward to CSMC a copy of any and all fully executed sublicense agreements, any subsequent amendments, and all copies of Permitted Sublicensees’ profit sharing or royalty reports, in no event more than thirty (30) days following execution or receipt thereof, as applicable. Licensee shall also keep CSMC reasonably informed with respect to the progress of any relations entered into with any Permitted Sublicensees. If Licensee shall conduct one or more audits of its Permitted Sublicensees hereunder during the term hereof, Licensee shall provide copies of all audit reports to CSMC on a timely basis. The covenants pertaining to the use of CSMC’s name and marks, the indemnification of CSMC and the use of CSMC’s Confidential Information in any sublicense or assignment shall run for the benefit of CSMC, who shall be expressly stated as being a third-party beneficiary thereof with respect to the covenants set forth in this Agreement. Licensee understands and agrees that none of its permitted sublicenses hereunder shall reduce in any manner any of its obligations set forth in this Agreement.

 

(a)          Required Sublicensing. If Licensee is unable or unwilling to serve or develop a potential market or market territory for which there is a company willing to be a Permitted Sublicensee, Licensee will, at CSMC’s request, negotiate in good faith a sublicense with any such Permitted Sublicensee.

 

(b)          Royalty-Free Sublicenses. If, and only if, Licensee pays all royalties due CSMC from a Permitted Sublicensee’s Net Sales, Licensee may grant that Permitted Sublicensee a royalty-free or non-cash sublicense or cross-license.

 

6
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

2.4           Sponsored Research. Licensee shall sponsor at CSMC, under an Investigational New Drug application, at least one of the clinical trials described in Schedule G attached hereto, for the purpose of testing an oral anti-methanogen for (a) constipation-predominant irritable bowel syndrome and/or (b) obesity/hypercholesterolemia/pre-diabetes, as may be further enumerated pursuant to the protocols and budgets to be mutually developed by the parties (each, a “Sponsored Clinical Trial”). In the event that Licensee conducts the second clinical trial described in Schedule G , Licensee agrees to sponsor such clinical trial at CSMC. Any inventions within the Field of Use that are (a) created, discovered or invented as a direct result of the Sponsored Clinical Trial(s) and (b) the practice of which are generally described in a specification of the Patent Rights (each, a “Sponsored Invention”), shall automatically be, and shall be deemed to be, without any further consideration and without any further action by the parties, part of the rights licensed to Licensee under Section 2.1 hereof; provided, however , that to the extent that any such Sponsored Invention is captured in a patent application, the parties shall amend Schedule A of this Agreement to include such patent application.

 

2.5           Improvements. Subject to the rights and applicable rules of the Funding Agencies, Licensee shall have, for a period of three (3) months after receipt by Licensee of written notice from CSMC disclosing an Improvement, the exclusive first right to negotiate with CSMC to obtain one or more licenses to the Improvement in the Field of Use upon such terms and conditions as shall be agreed by the parties hereto, which terms and conditions shall include provisions for fair market value consideration for the grant of any such licenses. If Licensee declines or fails to pursue a license to such Improvement in the Field of Use within the three (3) month period described above, or if the parties engage in good faith negotiations and fail to conclude negotiations for a license to such Improvement in the Field of Use within a six (6) month period from the date of such notice, then CSMC shall have the right to commence discussions with any other party concerning such Improvement. Subject to the provisions of this Section 2.5, Licensee acknowledges and agrees that CSMC expressly retains and reserves any and all right, title and interest in and to the Improvement, whether or not in the Field of Use and, accordingly, no license to any Improvement is granted to Licensee under this Agreement.

 

2.6           Licensee Developments. Licensee hereby grants, and shall require its Permitted Sublicensee(s) to grant to CSMC a nonexclusive, royalty-free, irrevocable, paid-up license, with the right to grant sublicenses to non-profit research institutions and governmental agencies, to practice and use Licensee Developments for non-commercial research purposes, which license shall include, without limitation, the rights to: (a) publish the scientific findings from research conducted by or through CSMC or on its behalf; provided, however , that Licensee is provided forty-five (45) days prior notice of any such publication and an opportunity to review such publication; (b) use any tangible or intangible information contained in the Licensee Developments (so long as CSMC shall treat such information as Confidential Information and maintain its confidentiality in accordance with Section 10 hereof), for CSMC’s internal teaching and other educationally-related and non-commercial (except for charges to its own patients) clinical purposes, where clinical use does not involve a third party funding grant to commercialize such information; and (c) obtain research funding from governmental and other nonprofit organizations (including grant applications).

 

7
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

2.7           Milestones. Licensee acknowledges that it is important to CSMC, and a requirement of the United States Government under Title 35, Section 203 of the United States Code, that Licensee pursue the development, commercialization and marketing of Licensed Products and Licensed Technology Products and otherwise exercises commercially reasonable efforts to maximize the value of this Agreement to CSMC. CSMC and Licensee have agreed on the Milestones set forth on Schedule F , with each such Milestone being deemed a separate and independent condition. Within sixty (60) days after each anniversary of the Effective Date, Licensee shall prepare and deliver to CSMC an annual written report (to be certified by an executive officer of Licensee) indicating its compliance with the Milestones. If Licensee believes that it is or will be unable to achieve such Milestones despite its diligent efforts, Licensee may request amendments or reasonable extensions to Schedule F in writing for CSMC’s consideration. Licensee agrees to provide any additional information reasonably required by CSMC to evaluate Licensee’s performance under this Agreement. If Licensee fails to meet any annual Milestone designated in Schedule F hereto, and has not obtained an extension or amendment to such Milestone(s), CSMC may, at its option and as its sole remedy for Licensee’ breach of this Section 2.7, upon written notice to Licensee, convert the exclusive license granted under Section 2.1 hereof to a non-exclusive license or to a co-exclusive license, or terminate the license.

 

3.           Representations And Warranties

 

3.1           Rights to Technology. Except for the rights, if any, of the Funding Agencies or the United States Government, CSMC represents and warrants to Licensee that, to the best of its actual, current knowledge (without investigation outside of CSMC as to such representations and warranties) (a) it has the right to grant the licenses in this Agreement; (b) it has not granted licenses to the Patent Rights or Technical Information to any other party that would restrict the rights granted hereunder except as stated herein; and (c) there are no claims, judgments or settlements to be paid by CSMC with respect the Patent Rights or Technical Information or pending claims or litigation relating to the Patent Rights or Technical Information. Except for any potential or actual rights of Funding Agencies or the United States Government, CSMC is not aware that any additional rights or licenses are necessary for Licensee to exercise its licensed rights granted by CSMC under this Agreement.

 

3.2           Limited Warranty; Certain Damages.

 

(a)          Limited Warranty. CSMC makes no representation or warranty other than those expressly specified in this Agreement. Licensee accepts the Patent Rights and the Technical Information on an “AS-IS” basis. OTHER THAN AS SET FORTH IN THIS AGREEMENT, CSMC MAKES NO OTHER WARRANTIES CONCERNING PATENT RIGHTS OR TECHNICAL INFORMATION COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO PATENT RIGHTS, TECHNICAL INFORMATION OR ANY PRODUCT. OTHER THAN AS SET FORTH IN THIS AGREEMENT CSMC MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY OR SCOPE OF PATENT RIGHTS, OR THAT ANY PRODUCT WILL BE FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING PATENT RIGHTS COVERED BY THIS AGREEMENT. LICENSEE HEREBY AGREES THAT LICENSEE WILL NOT GIVE, AND SHALL NOT PERMIT ANY AFFILIATES OR SUBLICENSEES OR AFFILIATES THEREOF TO GIVE, ANY SUCH WARRANTY OR REPRESENTATION TO THIRD PARTIES ON BEHALF OF CSMC.

 

8
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

(b)          Certain Damages. EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY SET FORTH IN SECTION 8, IN NO EVENT SHALL CSMC BE LIABLE FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER CSMC KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY SET FORTH IN SECTION 8, CSMC’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY LICENSEE TO CSMC UNDER THIS AGREEMENT. THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL APPLY TO ALL CLAIMS AND ACTIONS OF ANY KIND, WHETHER BASED ON CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO NEGLIGENCE), OR ANY OTHER GROUNDS.

 

3.3           Rights Retained by Funding Agencies . Licensee acknowledges that to the extent that the Patent Rights and Technical Information have been developed in part under one or more funding agreements (“Funding Agreements”) with one or more Funding Agencies, such Funding Agencies have certain statutory, non-exclusive rights relative thereto for use for government purposes as well as regulatory or statutory “march-in rights” (collectively, “Statutory Rights”). Licensee also acknowledges that to the extent that the Improvements may be developed in part under one or more Funding Agreements with one or more Funding Agencies, such Funding Agencies may have certain Statutory Rights relative thereto. This Agreement is explicitly made subject to such Statutory Rights and, to the extent of any conflict between any such Statutory Rights and this Agreement, such Statutory Rights shall prevail.

 

4.           Consideration

 

In consideration of the execution and delivery by CSMC of this Agreement, Licensee agrees as follows:

 

4.1           Initial License Fee. No later than thirty (30) days after the execution of this Agreement, Synthetic shall issue to CSMC $150,000 in shares of its common stock; provided that such share issuance shall be subject to Section 4.5 hereof and the execution of a Stock Purchase Agreement in the form attached hereto as Schedule C (the “Synthetic Stock Purchase Agreement”). Failure of Synthetic either to issue such shares to CSMC or pay the equivalent amount in cash to CSMC within thirty (30) days of the execution of this Agreement shall render this Agreement null and void ( ab initio ).

 

4.2           Reimbursement of Patent Expenses. No later than thirty (30) days after the execution of this Agreement, CSMC shall be reimbursed for its prior patent expenses related to Patent Rights through the issuance by Synthetic to CSMC of $220,000 in shares of its common stock; provided that such share issuance shall be subject to Section 4.5 hereof and the execution of the Synthetic Stock Purchase Agreement. Failure of Licensee either to issue such shares to CSMC or pay the equivalent amount in cash to CSMC within thirty (30) days of the execution of this Agreement shall render this Agreement null and void ( ab initio ).

 

9
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

4.3 Annual Maintenance Fee. Commencing on the second annual anniversary of this Agreement, and each anniversary thereof, Licensee shall pay CSMC an annual maintenance fee of $**** (“Maintenance Fee”). The Maintenance Fee shall be creditable against Royalties otherwise payable hereunder during the applicable twelve (12) month period; provided, however , that Licensee may not carry over to the following year any amount by which the Maintenance Fee paid exceeds the actual amount of Royalties payable hereunder during the applicable twelve (12) month period.

 

4.4           Licensee Equity Issuance. Prior to execution of this Agreement, Licensee shall have issued eleven and one-half percent (11.5%) of its issued and outstanding shares of common stock on a fully diluted basis to CSMC, subject to execution of a Stock Purchase Agreement in the form attached hereto as Schedule D (the “Licensee Stock Purchase Agreement”). Failure of Licensee to issue such shares shall render this Agreement null and void ( ab initio ). Such shares issued hereunder shall be of the same class and series as founders’ shares. A true and complete copy of Licensee’s capitalization table as of the Effective Date of the Agreement is set forth in Schedule E hereto. CSMC shall have the anti-dilution protections, tag-along rights and the right to exchange CSMC’s equity in Licensee for equity in Synthetic as set forth in the Licensee Stock Purchase Agreement.

 

4.5           Exchange Approval . The parties acknowledge that subject to Synthetic’s obligations under the Synthetic Stock Purchase Agreement(s), any issuance of stock by Synthetic hereunder, including with respect to the license fees, patent expense reimbursements, and Milestone payments referred to herein, may be subject to the prior approval of the NYSE MKT or any other exchange upon which the shares of Synthetic are traded, and shareholder approval, if so required by such exchange or any other rule or regulation applicable to the Licensee or Synthetic. Synthetic shall submit an application to the NYSE MKT for approval to issue the shares required to be issued under Sections 4.1 and 4.2 within five (5) days of the execution of this Agreement. In the event that Synthetic elects to pay either or both of the Phase I and Phase II Milestone payments described in Section 4.6(e)(ii) by issuing shares of Synthetic stock to CSMC, Synthetic shall submit an application to the NYSE MKT for approval to issue such shares within thirty (30) days of the occurrence of the applicable Milestone. In the event that Synthetic shall not have received shareholder approval or NYSE MKT approval to issue any such shares hereunder within fifteen (15) business days of the submission of any such application to the NYSE MKT, then Company shall instead make cash payments in satisfaction of its obligations under Sections 4.1, 4.2 and/or 4.6(e)(ii), as applicable.

  

10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

4.6           Royalties and Non-Royalty Revenue.

 

(a)          Running Royalties for Licensed Products and Licensed Technology Products. Licensee agrees to pay and shall pay to CSMC the following running royalties: (a) **** percent (****%) of Net Sales of Licensed Products made, used, sold or otherwise distributed by Licensee or any Permitted Sublicensee hereunder; and (b) **** percent (****%) of Net Sales of Licensed Technology Products made, used, sold or otherwise distributed by Licensee or any Permitted Sublicensee hereunder (each, a “Royalty”). If Licensee is required to make any payment to a third party to obtain a license for the manufacture, use, sale or import of a Licensed Product or Licensed Technology Product or otherwise exploit the Licensed Patent Rights, Licensee shall be entitled to deduct up to **** percent (****%) of such third party payments made in a particular calendar year against Royalties payable to CSMC for that year; provided, however , that in no event shall the Royalties payable to CSMC hereunder for any one-year period be reduced by operation of this section by more than **** percent (****%); and provided, further , that such third party payments shall only be creditable against Royalties payable to CSMC for the calendar year in which the third party payment was actually made by Licensee.

 

(b)          Licensee Challenge of Patent Rights. Should Licensee bring, directly or through a third party indirectly, an action challenging the validity, scope or enforceability of any Patent Rights, Licensee will first provide CSMC with at least ninety (90) days’ prior written notice that it intends so to do before filing such a challenge. Following the giving of such notice, Licensee will pay to CSMC the Royalties and Non-Royalty Sublicense Revenue due hereunder at the rate of two times the applicable rate during the pendency of such action. Should the outcome of such action determine that any claim of a patent challenged by Licensee is valid and/or infringed and/or enforceable, as applicable, Licensee will thereafter pay to CSMC the Royalties and Non-Royalty Sublicense Revenue due hereunder at the rate of three times the applicable rate for all Licensed Products and Licensed Technology Products sold that would infringe such claim and/or transactions that include a grant of rights to such claim. Such increased royalty reflects the increased value of the Patent Rights upheld in such action. In the event that a challenge of Patent Rights brought by Licensee is partially or entirely successful, Licensee will have no right to recoup any Royalties or other amounts paid before or during the period of the challenge. Additionally, Licensee agrees to disburse any and all proceeds received from any sublicense of the applicable Patent Rights throughout the duration of any such challenge to CSMC, and agrees to reimburse CSMC for all costs actually incurred by CSMC in connection with the applicable legal proceedings. In the event that all or any portion of this Section 4.6(b) is invalid, illegal or unenforceable, then the parties will use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, gives effect to the intent of this Section 4.6(b).

 

11
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

(c)          Arm’s-Length Transactions. On sales of Licensed Products and Licensed Technology Products which are made in other than an arms’-length transaction, the value of the Net Sales attributed under this Section 4.6 to such a transaction shall be that which would have been received in an arms’-length transaction, based on sales of like quality and quantity products on or about the time of such transaction.

 

(d)          Duration of Royalty Obligations. The royalty obligations of Licensee as to each Licensed Product shall terminate on the later of, on a country-by-country basis, (a) the expiration of the last to expire of a Valid Claim within the Patent Rights that covers such Licensed Product, including any term extensions thereof, or (b) twelve years after the first commercial sale of such Licensed Product. The royalty obligations of Licensee as to each Licensed Technology Product shall terminate twenty (20) years after the first commercial sale of such Licensed Technology Product.

 

(e)          Non-Royalty Revenues.

 

(i)          Non-Royalty Sublicense Revenues. Any and all “Non-Royalty Sublicense Revenues” shall be reported and paid to CSMC by Licensee as set forth below within sixty (60) days of receipt by Licensee. Licensee shall pay to CSMC a percentage of these Non-Royalty Sublicense Revenues according to the following schedule:

 

Effective Date of Sublicense Agreement   Percent of Non-Royalty Sublicense
Revenues Payable to CSMC
Prior to initiation of Phase I clinical trial   ****%
Prior to initiation of Phase II clinical trial   ****%
Prior to initiation of Phase III clinical trial   ****%
After initiation of Phase III clinical trial   ****%

 

Any non-cash consideration received by Licensee from Permitted Sublicensees shall be valued at its Fair Market Value as of the date of receipt and such amount shall be paid in cash to CSMC in accordance with the schedule above. In the event that the Patent Rights are sublicensed in combination with one or more patented technologies that are not covered under this Agreement, Non-Royalty Sublicense Revenues for the purposes of this Section 4.6(e) shall be calculated on a pro-rata basis in a manner to be mutually agreed by CSMC and Licensee (which agreement may be a condition of approval under Section 2.3).

 

12
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

(ii)         Product Development Milestones. Licensee agrees to pay and shall pay to CSMC the following non-creditable, non-refundable product development milestone payments within sixty (60) days of the first occurrence of a milestone (or its equivalent):

 

Milestone Event   Milestone Payment
     
On a Licensed Product by Licensed Product and Licensed Technology Product by Licensed Technology Product basis:    
     
Successful Phase I trial completion for first Licensed Product or first Licensed Technology Product   $**** (payable in cash or as $**** worth (at the time the payment is due) of stock of Synthetic at Licensee’s option, subject to the terms of the Synthetic Stock Purchase Agreement)
     
Successful Phase II trial completion for first Licensed Product or first Licensed Technology Product and thereafter upon initiation of Phase III patient dosing for each additional indication of a Licensed Product and/or Licensed Technology Product   $**** (payable in cash or as $**** worth (at the time the payment is due) of stock of Synthetic at Licensee’s option, subject to the terms of the Synthetic Stock Purchase Agreement
     
Successful Phase III trial completion   $****
     
FDA’s acceptance of the NDA   $****
     
Regulatory Approval   $****
     
First Commercial Sale   $****

 

For the avoidance of doubt, in the event that Licensee has paid CSMC the required milestone payments with respect to a Licensed Product or Licensed Technology Product, new milestone payments (as set forth above) shall be due in the event that the Licensee proceeds with the development of new indications of such Licensed Product or Licensed Technology Product and initiates Phase III patient dosing for such new indications; provided, however, that no new milestone payments shall be due in the event that Licensee proceeds with subsequent clinical trials testing different formulations or dosing requirements with respect to such Licensed Product or Licensed Technology Product.

 

13
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

(f)          Payment and Accounting.

 

(i)          Reports. Each payment of Royalties shall be accompanied by a report in the form attached as Schedule H hereto, which sets forth in reasonable detail the number and each type of Licensed Product and Licensed Technology Product sold and the calculation of Net Sales applicable thereto, and such additional details as may be reasonably requested by CSMC for the determination of Royalties payable hereunder. Licensed Products and Licensed Technology Products shall be considered as being sold for the purpose of the calculation of Royalties under this Agreement when payment has been received for the Licensed Products or Licensed Technology Products. Each payment of Non-Royalty Sublicense Revenue shall be accompanied by a report in the form attached as Schedule H hereto setting forth in reasonable detail the basis for the calculation of such amounts, and such additional details as may be reasonably requested by CSMC for the determination of Non-Royalty Sublicense Revenue payable hereunder. Hard copies of such reports shall be sent to CSMC’s address set forth in Section 13.1 of the Agreement, while an electronic copy shall be sent by electronic mail to CSTechTransfer@cshs.org . Except as otherwise provided herein, all amounts due hereunder shall be paid in United States dollars and shall be made without set off and free and clear of (and without any deduction or withholding for) any taxes, duties, levies, imposts or similar fees or charges. Royalties shall be payable by Licensee quarterly, within sixty (60) days after the end of each calendar quarter, based upon revenues received during the immediately preceding calendar quarter. Licensee agrees to pay and shall pay to CSMC, or cause its Permitted Sublicensees to pay to CSMC, all Royalties resulting from the activities of its Permitted Sublicensees, within sixty (60) days after the end of each calendar quarter in which Licensee has received payment from the Permitted Sublicensees.

 

(ii)         Notice of Payment. Licensee shall provide prompt written notice to CSMC that it has paid any annual maintenance fee required by Section 4.3 or any product development milestone payment required by Section 4.6(e) by electronic mail to CSTechTransfer@cshs.org .

 

(iii)        Wire Transfer Instructions. All payments due hereunder shall be made by Licensee to CSMC in accordance with the following wire transfer instructions:

 

****

 

14
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

(iv)        Records and Audits. Licensee shall create and maintain complete and accurate records and documentation concerning all sales of Licensed Products and Licensed Technology Products by Licensee, its Affiliates and Permitted Sublicensees as well as transactions based upon which Non-Royalty Sublicense Revenue is due, in sufficient detail to enable the Royalties and Non-Royalty Sublicense Revenue, respectively, that is payable hereunder to be determined. Licensee shall retain such records and documentation for not less than seven (7) years from the date of their creation. During the term of this Agreement and for a period of three (3) years thereafter, CSMC and its representatives shall have the right to audit such records and documentation as shall pertain to the determination and payment of Royalties and Non-Royalty Sublicense Revenue upon ten (10) days prior written notice to Licensee. Such examiners shall have reasonable access during regular business hours to Licensee’s offices and the relevant records, files and books of account, and shall have the right to examine any other records reasonably necessary to determine the accuracy of the calculations of Royalties and Non-Royalty Sublicense Revenue provided by Licensee; provided, however , that such examiners must execute a confidentiality agreement in form and substance satisfactory to Licensee. The costs of any such audit shall be borne by CSMC, unless as a result of such inspection it is determined that the amounts payable by Licensee for any period are in error by greater than five percent (5%), in which case the costs of such audit shall be borne by Licensee. CSMC shall report the results of any such audit to Licensee within thirty (30) days of completion. Thereafter, Licensee shall promptly pay to CSMC the amount of any underpayment discovered in such audit, or CSMC shall credit to Licensee against future Royalty payments the amount of any overpayment discovered in such audit, as the case may be. In addition, Licensee shall pay interest on any underpayment at the rate that is the lower of (i) two percent (2%) over the rate of interest announced by Bank of America in Los Angeles, California (or any successor in interest thereto or any commercially equivalent financial institution if no such successor exists) to be its “prime rate”, or (ii) the highest rate permitted by applicable law, from the date such amount was underpaid to the date payment is actually received.

 

(v)         Currency Transfer Restrictions. If any restrictions on the transfer of currency exist in any country or other jurisdiction so as to prevent Licensee from making payments to CSMC, Licensee shall take all commercially reasonable steps to obtain a waiver of such restrictions or to otherwise enable Licensee to make such payments. If Licensee is unable to do so, Licensee shall make such payments to CSMC in a bank account or other depository designated by CSMC in such country or jurisdiction, which payments shall be in the local currency of such country or jurisdiction, unless payment in United States dollars is permitted. Any payment by Licensee to CSMC in currencies other than United States dollars shall be calculated using the appropriate foreign exchange rate for such currency quoted in the California edition of The Wall Street Journal for the close of business of the last banking day of the calendar quarter in which such payment is being made.

 

(vi)        Late Charges. A service charge of two percent (2%) per month, not to exceed the maximum rate allowed by applicable law, shall be payable by Licensee on any portion of Licensee’s outstanding Royalty or Non-Royalty Sublicense Revenue balance or any other amount payable by Licensee hereunder that is not paid to CSMC within thirty (30) days past the due date

 

15
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

(vii)       Taxes. Licensee shall pay, or cause to be paid, any and all taxes required to be paid or withheld on any sales, licenses or other transfers for value of Licensed Products, Licensed Technology Products or Patent Rights (other than taxes imposed on the income or revenues of CSMC); provided, however, that under no circumstances shall the amounts of such taxes be deducted from the total amount of payments otherwise due to CSMC hereunder. Upon CSMC’s request, Licensee shall secure and send to CSMC proof of any such taxes withheld and paid by Licensee, its Affiliates or Permitted Sublicensees.

 

(viii)      No Escrow. Licensee shall pay all Royalties and Non-Royalty Sublicense Revenue directly to CSMC and shall not pay royalties into any escrow or other similar account, including in the event of a validity or non-infringement challenge to the Patent Rights.

 

5.           Patent Rights

 

5.1           Prosecution. CSMC will continue to have full responsibility for the application, maintenance, reexamination, reissue, opposition and prosecution of any kind relating to the Patent Rights in the Territory (“Prosecution”) with due input from Licensee and using counsel reasonably acceptable to Licensee; provided, however, that CSMC’s patent counsel shall bill Licensee directly for all costs and expenses, including reasonable attorneys’ fees, filing fees and translation fees incurred in the prosecution of the Patent Rights (“Prosecution Costs”).

 

5.2           Abandonment, Disclaimers, etc. CSMC shall not abandon, disclaim, withdraw, seek reissue or allow to lapse any patent or patent application within the Patent Rights as long as Licensee continues to timely and fully pay all Prosecution Costs as set forth in Section 5.1; provided, however , that Licensee may elect to notify CSMC of its decision not to continue to pay the Prosecution Costs to prosecute or maintain a patent or patent application included in the Patent Rights in various jurisdictions at least forty-five (45) days before a final due date which would result in abandonment or bar of patentability of the patent or patent application with respect to such jurisdiction. In such event, CSMC may, at its sole option, continue Prosecution of the patent application or patent at its own cost and expense; provided, however , that in the event that CSMC intends to develop or commercialize any product in such jurisdiction with any third party based upon such patent or patent application, Licensee shall have an exclusive first right of negotiation for a period lasting sixty (60) days following notice from CSMC to Licensee of its intent to so develop or commercialize with respect to such patent or patent application, and if Licensee either does not exercise such right or if a license is not concluded with Licensee within the aforesaid sixty (60)-day period, then this right shall expire and CSMC shall have no further obligation to Licensee with respect to such patent or patent application.

 

5.3           CREATE Act. Licensee shall not invoke the Cooperative Research and Technology Enhancement Act of 2004, as set forth under Title 35, Section 102(c) of the United States Code (the “CREATE Act”), with respect to the Patent Rights without first obtaining the prior written consent of CSMC.

 

16
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

6.           Term And Termination

 

6.1           Term. Unless earlier terminated as provided in Section 6.2 hereof, the term of this Agreement shall commence on the Effective Date and shall expire, on a country-by-country and Licensed Product-by-Licensed Product and/or Licensed Technology Product-by-Licensed Technology Product basis, upon expiration of Licensee’s obligation to pay royalties for such Licensed Product or Licensed Technology Product in such country.

 

6.2           Termination. Except as provided by Section 6.3 hereof, and in addition to the termination provisions of Section 2.7, this Agreement shall terminate upon the earliest to occur of the following:

 

(a)           Automatically if Licensee shall enter into a liquidating bankruptcy, be adjudged insolvent, liquidate, dissolve and/or if the business of Licensee shall be placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Licensee or otherwise; provided, however, that if any such action is involuntary, termination shall not take place unless the action is not reversed within thirty (30) days. Further, Licensee shall give CSMC at least forty-five (45) days’ prior written notice before Licensee initiates any bankruptcy proceeding, and CSMC shall have the right to terminate this Agreement immediately upon receipt of such notice;

 

(b)           Automatically if the performance by either party to this Agreement of any term, covenant, condition or provision hereof: (i) shall jeopardize (A) the licensure of CSMC; (B) CSMC’s participation in the Medicare, Medi-Cal or other reimbursement or payment programs; (C) the full accreditation of CSMC by the Joint Commission of Accreditation of Healthcare Organizations or any other state or nationally recognized accreditation organization; or (D) CSMC’s tax-exempt status; or (ii) is deemed illegal or unethical by any recognized governmental agency or body. Upon the occurrence of any of the items set forth in this subparagraph (b), CSMC shall provide written notice to Licensee setting forth the reason for such termination (which termination shall be effective immediately);

 

(c)           Upon thirty (30) days’ written notice from CSMC if, within such thirty (30) day period (i) Licensee shall fail to pay fully any Royalty or Non-Royalty Sublicense Revenue payment required by Section 4.3 hereof, or (ii) Licensee shall fail to undertake commercially reasonable efforts to exploit the Patent Rights in the Field of Use in the Territory, regardless of Licensee’s satisfaction of the Milestones provided in Schedule F hereto;

 

(d)           Upon sixty (60) days’ written notice from CSMC if, within such sixty (60) day period, Licensee shall fail to cure fully any breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach with reasonable specificity; provided, however, that Licensee may avoid such termination if, before the end of such 60-day period, such breach or default has been cured by Licensee to the reasonable satisfaction of CSMC;

 

17
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

 

(e)           Upon ninety (90) days’ written notice from Licensee if, within such ninety (90) day period, CSMC shall fail to cure fully any breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach with reasonable specificity; provided, however, that CSMC may avoid such termination if, before the end of such 90-day period, such breach or default has been cured by CSMC to the reasonable satisfaction of Licensee;

 

(f)           Licensee shall have the right to terminate this Agreement at any time without cause upon six (6) months written notice to CSMC; provided, however , that in the event of such termination without cause by Licensee, Licensee shall pay to CSMC a termination fee calculated in accordance with the following table no later than the effective date of termination:

 

Time of Termination   Termination Fee  
Prior to IND Submission   $ ****  
Prior to completion of Phase II clinical trial   $ ****  
Prior to completion of Phase III clinical trial   $ ****  
Following completion of Phase III clinical trial   $ ****  

 

(g)           Upon the mutual written agreement of the parties hereto (such termination to be effective as of the date mutually agreed upon in such written agreement).

 

6.3           Obligations Upon Termination. Upon any termination of this Agreement pursuant to Section 6.2 hereof, nothing herein shall be construed to release any party from any liability for any obligation incurred through the effective date of termination (e.g., confidentiality, reimbursement of patent expenses incurred prior to such date, etc.) or for any breach of this Agreement prior to the effective date of such termination. Obligations which accrued prior to termination (including milestones which have been triggered) would survive termination.

 

Licensee may, for a period of one (1) year after the effective date of such termination, sell all tangible Licensed Products and Licensed Technology Products customarily classified as “inventory” that it has on hand at the date of termination, subject to payment by Licensee to CSMC of the applicable Royalty and Non-Royalty Sublicense Revenue; provided, however , that any such action by Licensee does not subject CSMC to any of the occurrences set forth in Section 6.2(b) hereof.

 

 

18
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

6.4           Effect of Termination. In the event of any termination of this Agreement pursuant to Section 6.2 hereof, where such termination has not been caused by any action or inaction on the part of any Permitted Sublicensee of Licensee or by any breach by such Permitted Sublicensee of its obligations under its sublicense from Licensee, such termination of this Agreement shall be without prejudice to the rights of each non-breaching Permitted Sublicensee of Licensee and each non-breaching Permitted Sublicensee shall be deemed to be a licensee of CSMC thereunder, and CSMC shall be entitled to all rights, but shall not be subject to any obligations (other than the grant of license and appurtenant obligations under this Agreement to the extent provided for in such sublicense) of Licensee thereunder. This Section 6.4, however, shall not be applicable if this Agreement has been terminated under Section 6.2(b) under circumstances where the application of this Section 6.4 would subject CSMC to any of the occurrences set forth in Section 6.2(b).

 

6.5           Right to Institute Legal Actions. Notwithstanding the provisions of Section 6.2 hereof, CSMC, on the one hand, and Licensee, on the other hand, may institute any other legal action or pursue any other remedy against the other party permitted by applicable law if the other party does not substantially cure any breach or default of any material obligation as provided herein.

 

6.6           Reversion of Rights. Notwithstanding anything to the contrary set forth herein (including, but not limited to, Section 5 hereof), full responsibility for Prosecution of the Patent Rights shall, at the option of CSMC (exercisable in its sole and absolute discretion), and at its sole expense from the date of reversion, revert to CSMC upon any termination of this Agreement.

 

6.7           Return of Data. In the event of any termination or expiration of this Agreement, Licensee may consider providing CSMC with copies of data, information and materials obtained or generated by or on behalf of Licensee in the course of conducting research and developing Licensed Products and Licensed Technology Products using the Patent Rights and the Technical Information.

 

19
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

7.           Infringement By Third Parties

 

7.1           Enforcement. Subject to contradictory obligations CSMC may have to any other licensee thereof, Licensee shall have the first right and the obligation to enforce, at its sole expense, any Patent Rights to the extent licensed hereunder against infringement by third parties and shall notify CSMC in writing in advance of all such enforcement efforts. Upon Licensee’s undertaking to pay all expenditures reasonably incurred by CSMC, CSMC shall reasonably cooperate in any such enforcement and, as necessary, join as a party therein. Licensee shall reimburse CSMC for all expenses, including reasonable attorneys’ fees, incurred in connection with any such enforcement. In the event that Licensee does not file suit against or commence and conclude settlement negotiations with a substantial infringer of Patent Rights within ninety (90) days of receipt of a written demand from CSMC that Licensee bring suit, then the parties will consult with one another in an effort to determine whether a reasonably prudent licensee would institute litigation to enforce the patent in question in light of all relevant business and economic factors (including, but not limited to, the projected cost of such litigation, the likelihood of success on the merits, the probable amount of any damage award, the prospects for satisfaction of any judgment against the alleged infringer, the possibility of counterclaims against the parties hereto, the impact of any possible adverse outcome on Licensee and the effect any publicity might have on the parties’ respective reputations and goodwill). If, after such process, it is determined that a suit should be filed and Licensee does not file suit or commence settlement negotiations forthwith against the infringer, then CSMC shall have the right, at its own expense, to enforce any Patent Rights licensed hereunder on behalf of itself and Licensee. Any damages or other recovery from an infringement action undertaken by Licensee shall first be used to reimburse the parties, on a pro rata pari passu basis, for the costs and expenses incurred in such action, and shall thereafter be allocated between the parties as follows: (i) fifty percent (50%) to CSMC and (ii) fifty percent (50%) to Licensee. If Licensee fails to prosecute any such action to completion, then any damages or other recovery net of the parties’ costs and expenses incurred in such infringement action shall be the sole property of CSMC. The foregoing notwithstanding, to the extent that any portion of damages awarded in a lawsuit brought by Licensee are specifically allocated in a judgment as lost sales, the amount due to CSMC for such amount shall be based on treating such amount as Net Sales.

 

7.2           Defense of Patent Rights. In the event that any Patent Rights are the subject of a legal action seeking declaratory relief or of any reexamination or opposition proceeding instituted by a third party, the parties agree to promptly consult with each other concerning the defense of such actions or proceedings. If the parties agree that such defense should be undertaken, then Licensee shall bear the expenses, including attorneys’ fees, associated with such defense and in any recoupment of expenses. If the parties disagree, then the party desiring to defend the action or proceeding may proceed with such defense and will bear its own expenses, and be entitled to all sums recovered.

 

20
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

8.           Indemnification

 

8.1           Indemnification by Licensee. Subject to Section 8.2 hereof, Licensee shall hold harmless, defend and indemnify CSMC and each of its officers, directors, employees (including the Inventors), agents and sponsors of the research (except Licensee) (each, an “Indemnified Party”, and collectively, the “Indemnified Parties”) from and against any and all claims, damages, losses, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses and costs of investigation, whether or not suit is filed) suffered or incurred by any of the Indemnified Parties in any action, suit, litigation, arbitration or dispute of any kind (“Action”) arising or resulting from any negligence or willful acts or omissions on the part of Licensee, its Affiliates or Permitted Sublicensees in connection with (a) their use the Patent Rights or Technical Information and/or (b) the exercise of their rights hereunder or under any sublicense, including, but not limited to (i) the preclinical development and clinical testing of Licensed Products or Licensed Technology Products, and (ii) the manufacture, sale, use, marketing, or other disposition of Licensed Products or Licensed Technology Products developed, manufactured, sold, marketed, used or otherwise disposed of under this Agreement. As part of its obligations hereunder, Licensee shall defend any Action brought against any of the Indemnified Parties with counsel of its own choosing and reasonably acceptable to CSMC, and neither CSMC nor any other Indemnified Party shall enter into any settlement of any such Action without first obtaining prior approval of Licensee. Licensee shall pay all costs, including attorney’s fees, incurred in enforcing this indemnification provision. Should CSMC or any other Indemnified Party not afford Licensee the right to defend any such Action, or should CSMC or any other Indemnified Party not obtain the approval of Licensee to any such settlement, Licensee shall have no obligation to indemnify CSMC or any other Indemnified Party hereunder. Should Licensee fail to provide a defense for the Indemnified Parties as required hereunder, then Licensee shall reimburse CSMC for its out-of-pocket expenses (including reasonable attorneys’ fees and expenses and costs of investigation) which are incurred as a result of any investigation, defense or settlement relating to the foregoing, which reimbursement shall be made to CSMC upon receipt by Licensee of invoices reflecting in reasonable detail such expenses incurred by CSMC. Licensee shall obtain and maintain insurance policies (including products liability and general liability policies at such time as is appropriate) which are reasonable and necessary to cover its activities and to comply with the indemnification obligations set forth above. Such insurance policies shall name CSMC as an additional insured party and shall provide a minimum of $3,000,000 in coverage per occurrence. Upon initiation of any human clinical studies of Licensed Products or Licensed Technology Products, Licensee shall have first increased its insurance coverage to a minimum of $10,000,000 in the aggregate. Licensee shall provide CSMC with prompt written notice of any material change in coverage under such policies. If the parties determine that evidence of Licensee’s insurance coverage is necessary and appropriate, within thirty (30) days of the Effective Date (subject to extension if reasonably required) and annually thereafter, Licensee shall provide CSMC with a certificate of insurance issued by the appropriate insurance company evidencing the insurance coverage required by this Section 8.1, together with copies of the endorsement which specifies CSMC as an additional insured and the declarations page for each such insurance policy. The certificate of insurance, endorsements and declarations pages (and any renewals or replacements thereof), if required, shall be sent to CSMC’s Technology Transfer Office by electronic mail at CSTechTransfer@cshs.org and by prepaid, first class, certified mail, return receipt requested, at the following address: 8797 Beverly Boulevard, Suite 206, Los Angeles, CA 90048.

 

8.2           Notice of Claim. CSMC shall promptly notify Licensee in writing of any claim or Action or material threat thereof brought against any Indemnified Party in respect of which indemnification may be sought and, to the extent allowed by law, shall reasonably cooperate with Licensee in defending or settling any such claim or Action. No settlement of any claim, Action or threat thereof received by CSMC and for which CSMC intends to seek indemnification (for itself or on behalf of any other Indemnified Party) shall be made without the prior joint written approval of Licensee and CSMC.

 

21
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

9.           Use Of Names

 

Licensee shall not, unless as required by any law or governmental regulation, use the name of CSMC, and/or any of its trademarks, service marks, trade names or fictitious business names without express prior written consent of the Vice President for Public Relations and Marketing of CSMC. Further, prior to any reference by Licensee to the names or marks of CSMC in any manner, Licensee shall provide CSMC with a writing reflecting the proposed reference so that CSMC can review the reference within a reasonable period of time prior to the proposed use thereof by Licensee. This limitation includes, but is not limited to, use by Licensee in any regulatory filing, advertising, offering circular, prospectus, sales presentation, news release or trade publication. Notwithstanding the foregoing, certain specific language shall be mutually agreed upon by the parties for Licensee’s use in certain contexts and with respect to certain topics, and once agreed upon, may be utilized by Licensee in connection with the approved contexts and topics without further permission of CSMC. Subject to compliance by Licensee with the foregoing, which shall be deemed conditions precedent to any use of CSMC’s name or marks by Licensee, Licensee shall ensure that the name of CSMC is used as scientifically or academically appropriate in the “byline” of any article, abstract, manuscript or any other publication related to the subject matter hereof.

 

10.        Confidentiality

 

10.1         Non-Disclosure. The parties hereto shall keep the terms of this Agreement and all business and scientific discussions relating to the business of the parties strictly confidential. All patient information to which a party is given access by the other party shall be subject to the provisions of the Confidentiality of Medical Information Act (Cal. Civ. Code §§56, et seq.) and the Health Insurance Portability and Accountability Act of 1996, and all regulations promulgated thereunder. It may, from time to time, be necessary for the parties, in connection with performance under this Agreement, to disclose Confidential Information (including know-how) to each other. The Receiving Party (as defined in Section 1.2 hereof) shall keep in strictest confidence the Confidential Information of the Disclosing Party (as defined in Section 1.2 hereof), using the standard of care it normally uses for information of like character, and shall not disclose the Confidential Information to any third party or use it except as expressly authorized by the prior written consent of the Disclosing Party or as otherwise permitted by this Agreement; provided, however, that Licensee may disclose the Confidential Information received from CSMC to its Affiliates and Permitted Sublicensees as shall be reasonably necessary to carry out the intent of this Agreement or any sublicense granted by Licensee as contemplated by this Agreement if, but only if, such Affiliates and/or Permitted Sublicensees each execute a confidentiality agreement containing confidentiality provisions no less restrictive than those confidentiality provisions contained in this Section 10. The Receiving Party’s obligation hereunder shall not apply to Confidential Information that the Receiving Party can show by written documentation:

 

(a)           Is or later becomes part of the public domain through no fault or neglect of the Receiving Party;

 

(b)           Is received in good faith from a third party having no obligations of confidentiality to the Disclosing Party, provided, however, that the Receiving Party complies with any restrictions imposed by the third party;

 

(c)           Is independently developed by the Receiving Party without use of the Disclosing Party’s Confidential Information as shown by its books and records at the time of disclosure; or

 

(d)           Is required by law or regulation to be disclosed (including, without limitation, in connection with FDA filings, filings with another government agency or as required under the California Public Records Act), provided, however, that the Receiving Party uses reasonable efforts to restrict disclosure and to obtain confidential treatment.

 

22
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

10.2         Limits on Permitted Disclosures. Each party agrees that any disclosure or distribution of the other party’s Confidential Information within its own organization shall be made only as is reasonably necessary to carry out the intent of this Agreement. The parties further agree that all of their respective officers, employees, agents, representatives or approved sublicensees to whom any Confidential Information is disclosed or distributed shall have agreed to maintain its confidentiality. In such event, the Receiving Party shall identify with reasonable particularity, upon request by the Disclosing Party, each person within the Receiving Party’s organization to whom the Receiving Party has disclosed or distributed Confidential Information.

 

10.3         Legally Required Disclosures. If a subpoena or other legal process concerning Confidential Information is served upon any party hereto pertaining to the subject matter hereof, the party served shall notify the other party immediately, the other party shall cooperate with the party served, at the other party’s expense, in any effort to contest the validity of such subpoena or other legal process. This Section 10.3 shall not be construed in any way to limit any party’s ability to satisfy any disclosure of its relationship with the other party required by any governmental authority. Notwithstanding anything to the contrary set forth in Section 10.1, the parties hereto acknowledge that Synthetic may be obligated to file a copy of this Agreement, any Schedules hereto, and summaries of the terms hereof with the U.S. Securities and Exchange Commission as reasonably required to comply with applicable laws or the rules of a nationally-recognized securities exchange. Synthetic shall be entitled to make such filings, provided that it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available. In the event of any such filing, Synthetic will provide CSMC with a copy of this Agreement (including the Schedules hereto) and related filings marked to show provisions for which Synthetic intends to seek confidential treatment and shall reasonably consider and incorporate CSMC’s comments thereon to the extent consistent with the legal requirements and the rules of any nationally recognized securities exchange governing disclosure of material agreements and material information to be publicly filed.

 

10.4         Patent Rights as Confidential Information. The Patent Rights are understood by Licensee to be the Confidential Information of CSMC to the extent “unpublished” as such term is construed under the United States Patent Laws. As such, Licensee’s confidentiality obligations hereunder automatically extend to any and all Technical Information and to any and all patent applications of CSMC relating to any Patent Rights, Technical Information and Improvements and to any and all communications with the United States Patent Office, and any foreign patent office relating to any Patent Rights, Technical Information or Improvements.

 

10.5         Return of Confidential Information. In the event of any termination of this Agreement, the Receiving Party, upon request, shall promptly return all Confidential Information and any copies made thereof previously made available to the Receiving Party by the Disclosing Party.

 

10.6         Remedies. Both parties acknowledge and agree that it would be difficult to measure damages for breach by either party of the covenants set forth in this Section 10, and that injury from any such breach would be incalculable, and that money damages would therefore be an inadequate remedy for any such breach. Accordingly, either party shall be entitled, in addition to all other remedies available hereunder or under law or equity, without the obligation of posting a bond, to injunctive or such other equitable relief as a court may deem appropriate to restrain or remedy any breach of such covenants.

 

23
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

11.          Information Exchange

 

In addition to the Patent Rights and Technical Information, the parties shall cooperate to exchange such non-confidential information as may be appropriate and necessary to facilitate Licensee’s development and commercialization of Licensed Products and Licensed Technology Products incorporating any Patent Rights or Technical Information.

 

12.          Patent Marking

 

In the event any Licensed Product or Licensed Technology Product is the subject of a patent under the Patent Rights, Licensee shall actually or virtually mark all Licensed Products and Licensed Technology Products made, sold or otherwise disposed of by or on behalf of it or any of its Permitted Sublicensees as set forth under Title 35, Section 287(a) of the United States Code and shall respond to any request or disclosure under Title 35, Section 287(b)(4)(B) of the United States Code by only notifying CSMC of the request for disclosure.

 

13.          Miscellaneous

 

13.1         Notices. Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to have been given: (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient; (b) if sent by Federal Express or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient; or (c) if sent by facsimile transmission, when so sent and when receipt has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:

 

In the case of CSMC to:

 

Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California 90048-1865
Attention: Senior Vice President for Academic Affairs

 

with a copy to Senior Vice President for Legal Affairs & General Counsel

 

or in the case of Synthetic Biologics, Inc. or Licensee to:

 

Synthetic Biologics, Inc.
155 Gibbs Street, Suite 412
Rockville, Maryland 20850
Attention: Jeffrey Riley, CEO
email: jriley@syntheticbiologics.com

 

24
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

    with a copy to:

 

Gracin & Marlow, LLP
The Chrysler Building
405 Lexington Avenue, 26 th Floor
New York, New York 10174
Attention: Leslie Marlow, Esq.
email: lmarlow@gracinmarlow.com

 

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 13.1.

 

13.2         Compliance with Laws. Each party shall comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this Agreement.

 

13.3         Governing Law. For any dispute between the parties to this Agreement which arises from or relates to this Agreement, the Agreement shall be construed and enforced in accordance with the laws of the United States of America and of the State of California, irrespective of choice of laws provisions. The parties agree that Los Angeles County, California shall be the situs of any legal proceeding arising out of or relating to this Agreement. Each party hereby waives any right it may have to assert the doctrine of forum non conveniens or similar doctrine or to object to venue with respect to any proceeding brought in accordance with this Section, and stipulates that the state and federal courts located in Los Angeles, California shall have in personam jurisdiction and venue over each of them for the purpose of litigating any dispute, controversy, or proceeding arising out of or related to this Agreement. Each party hereby authorizes and accepts service of process sufficient for personal jurisdiction in any action against it as contemplated by this Section by registered or certified mail, return receipt requested, postage prepaid, to its address for the giving of notices as set forth in this Agreement.

 

13.4         Waiver. Failure of any party to enforce a right under this Agreement shall not act as a waiver of that right or the ability to assert that right relative to the particular situation involved.

 

13.5         Enforceability. If any provision of this Agreement shall be found by a court of competent jurisdiction to be void, invalid or unenforceable, the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or enforceability of the remainder of this Agreement.

 

13.6         Modification. No change, modification, or addition or amendment to this Agreement, or waiver of any term or condition of this Agreement, is valid or enforceable unless in writing and signed and dated by the authorized officers of the parties to this Agreement.

 

13.7         Entire Agreement. This Agreement and the Schedules hereto (which are incorporated herein by this reference as if fully set forth herein) constitute the entire agreement between the parties with respect to the subject matter hereof and thereof, and replace and supersede as of the date hereof and thereof any and all prior agreements and understandings, whether oral or written, between the parties with respect to the subject matter of such agreements.

 

25
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

13.8         Construction. This Agreement has been prepared, examined, negotiated and revised by each party and their respective attorneys, and no implication shall be drawn and no provision shall be construed against any party to this Agreement by virtue of the purported identity of the drafter of this Agreement or any portion thereof.

 

13.9         Counterparts. This Agreement may be executed simultaneously in one or more counterparts, each of which shall constitute one and the same instrument. This Agreement may be executed by facsimile or in .pdf format.

 

13.10         Attorneys’ Fees. In the event of any action at law or in equity between the parties hereto to enforce any of the provisions hereof, the unsuccessful party to such litigation shall pay to the successful party all reasonable costs and expenses, including reasonable attorneys’ fees, incurred therein by such successful party; and if such successful party shall recover a judgment in any such action or proceeding, such reasonable costs, expenses and attorneys’ fees may be included in and as part of such judgment.

 

13.11         Assignment; Successors.

 

(a)           Licensee may assign this Agreement to an Affiliate upon the prior written consent of CSMC. Subject to Section 13.11(b), Licensee may assign this Agreement without the consent of CSMC as part of a sale, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, or any other transfer of Licensee’s entire business, or that part of Licensee’s business that exercises all rights granted under this Agreement. Any other attempt to assign this Agreement by Licensee is null and void. In the event of a bankruptcy, assignment is permitted only to a party that can provide adequate assurance of future performance, including diligent development and sales, of Licensed Products and Licensed Technology Products. Synthetic shall have no right to assign this Agreement without the consent of CSMC other than as part of a sale of Synthetic, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, or any other transfer of Synthetic’s entire business; provided, however , that the successor entity shall have (a) a market capitalization greater than that of Synthetic at the time of the sale and (b) the ability to assume Synthetic’s guarantee obligations under Section 2.2 hereof; provided, further , that in the event that such sale occurs prior to the payment of the first and/or second milestone payment required by Section 4.6(e)(ii), then notwithstanding anything to the contrary set forth herein, such milestone payments shall be payable either in cash or stock of the successor entity in the amounts set forth in Section 4.6(e)(ii), at CSMC’s sole discretion,.

 

(b)           Prior to any assignment, the following conditions must be met: (i) Licensee or Synthetic, as the case may be, must give CSMC thirty (30) days prior written notice of the assignment, including the new assignee’s contact information, (ii) the new assignee must agree in writing to CSMC to be bound by this Agreement, and (iii) CSMC must have received a $25,000.00 assignment fee.

 

(c)           Subject to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of any successors in interest and assigns of CSMC, Licensee and Synthetic. CSMC shall have the right to assign its rights hereunder as part of any reorganization or bond financing.

 

26
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

13.12         Further Assurances. At any time and from time to time after the Effective Date, each party shall do, execute, acknowledge and deliver, and cause to be done, executed, acknowledged or delivered, all such further acts, transfers, conveyances, assignments or assurances as may be reasonably required to consummate the transactions contemplated by this Agreement.

 

13.13         Survival. The following sections shall survive any expiration or earlier termination of this Agreement: 4.6(e), 6.3, 8, 9, 10, 12 and 13.

 

[signature page follows]

 

27
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

IN WITNESS WHEREOF , the parties have caused their duly authorized representatives to execute this Agreement as of the date first above written.

 

  “LICENSEE”:
   
  SYNTHETIC BIOMICS, INC., a nevada corporation
     
  By: /s/ Steve Kanzer
  Name: Steve Kanzer
  Title: CEO & President
   
  Date:  
   
  SYNTHETIC BIOLOGICS, INC.,
  a nevada corporation
     
  By: /s/ Jeff Riley
  Name:

Jeff Riley

  Title: CEO
   
  Date:  

 

  “CSMC”:
   
 

Cedars-Sinai Medical Center, a

california nonprofit public benefit

corporation

     
  By: /s/ Shlomo Melmed, M.D.
    Shlomo Melmed, M.D.
    Senior Vice President for Academic Affairs and Dean of the Medical Faculty
     
  Date:    
     
  By: /s/ Richard Katzman
    Richard Katzman
    Vice President, Academic Affairs
     
  Date:  

 

28
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

ACKNOWLEDGED AND AGREED:  
   
“INVENTORS”:  
   
/s/ Mark Pimentel, M.D.  
Mark Pimentel, M.D.  
   
/s/ Christopher Chang, M.D.  
Christopher Chang, M.D.  
   
/s/ Ruchi Mathur, M.D.  
Ruchi Mathur, M.D.  

 

29
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Schedule A

 

Patent Rights

 

Country Serial No

Filing 

Date

Patent

No

Title Status
AUSTRIA 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
BELGIUM 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
SWITZERLAND 00952739.1 8/11/2000 1200828 METHODS OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS GRANTED
SWITZERLAND 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED

  

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

CYPRUS 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
GERMANY 00952739.1 8/11/2000 60036871.8 METHODS OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS GRANTED
GERMANY 07075358.7 8/11/2000 60046160.2 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
DENMARK 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
EUROPEAN PATENT OFFICE 00952739.1 8/11/2000 1200828 METHODS OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS GRANTED
EUROPEAN PATENT OFFICE 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
EUROPEAN PATENT OFFICE 10177153.3 8/11/2000   METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS FILED
EUROPEAN PATENT OFFICE 10183223.6 8/11/2000   METHODS OF DIAGNOSING AND TREATING CROHN'S DISEASE FILED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

EUROPEAN PATENT OFFICE 10183213.7 8/11/2000  

METHODS OF TREATING BLOATING, ABDOMINAL PAIN AND DIARRHEA

 

 

FILED
**** **** **** **** **** ****
SPAIN 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

FINLAND 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
**** **** **** **** **** ****
FRANCE 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
UNITED KINGDOM 00952739.1 8/11/2000 1200828 METHODS OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

UNITED KINGDOM 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
GREECE 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
IRELAND 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
ITALY 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

LUXEMBOURG 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
MONACO 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
NETHERLANDS 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
PORTUGAL 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

SWEDEN 07075358.7 8/11/2000 1811303 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
UNITED STATES 09/374,142 8/11/1999 6,861,053 METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
UNITED STATES 10/107,240 3/26/2002 6,805,852 METHODS OF DIAGNOSING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
UNITED STATES 10/915,193 8/10/2004 7,056,686 METHOD OF DIAGNOSING FIBROMYALGIA CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

UNITED STATES 11/838,631 8/14/2007 7,585,838 METHODS OF TREATING FIBROMYALGIA CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
UNITED STATES 13/073,169 3/28/2011 8,197,805 METHODS OF TREATING AUTOIMMUNE DISEASES CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH GRANTED
WIPO US2000/
22030
8/11/2000   METHODS OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS NAT'L PHASE FILED
AUSTRALIA 2002256254 4/16/2002 2002256254 METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS GRANTED
AUSTRALIA 2007201246 4/16/2002 2007201246 METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

CANADA 2,444,548 4/16/2002   METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS FILED
EUROPEAN PATENT OFFICE 02725704.7 4/16/2002   METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS FILED
EUROPEAN PATENT OFFICE 10178066.6 4/16/2002   METHODS OF DETECTING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) IN A HUMAN SUBJECT FILED
EUROPEAN PATENT OFFICE 10181342.6 4/16/2002   METHODS OF TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS FILED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

JAPAN 2002-582263 4/16/2002 4653936

METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS

 

GRANTED
**** **** ****   **** ****
UNITED STATES 09/837,797 4/17/2001 7,048,906 METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS GRANTED
UNITED STATES 11/348,995 2/7/2006 7,736,622 METHODS OF DIAGNOSING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS GRANTED

 

 

UNITED STATES 12/768,531 4/27/2010 8,110,177 METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS GRANTED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

UNITED STATES 13/315,671 12/9/2011 8,388,935 METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS GRANTED
UNITED STATES 13/755,515 1/31/2013   METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS FILED
UNITED STATES 14/025,531 9/12/2013   METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS FILED
WIPO US2002/
12034
4/16/2002   METHODS OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS NAT'L PHASE FILED

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

UNITED STATES 12/050,736 3/18/2008  

DIAGNOSIS OF CONSTIPATION BY ANALYSIS OF METHANE CONCENTRATION

 

 

FILED
UNITED STATES **** ****   ****Unpublished FILED
UNITED STATES **** ****   ****Unpublished FILED
UNITED STATES       ANTI-METHANOGEN COMPOSITIONS AND USES THEREOF  

 

and all divisions, continuations, continuations-in-part, reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, except as excluded under the definition of Patent Rights.

 

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Schedule B

 

Technical Information

 

1. The following information or material in the Field of Use which is embodied in the Patent Rights conceived or reduced to practice prior to the Effective Date in the conduct of research performed at CSMC under the direction of the Inventors:Hwang L, Low K, Khoshini R, Melmed G, Sahakian A, Makhani M, Pokkunuri V,  Pimentel M. Evaluating breath methane as a diagnostic test for constipation predominant IBS. Dig Dis Sci2010;55:398-403.

 

2. Low K, Hwang L, Hua J, Zhu A, Morales W, Pimentel M A combination of rifaximin and neomcyin is most effective in treating IBS patients with methane on lactulose breath test. J Clin Gastroenterol 2010 Sep;44(8):547-50.

 

3. Shah ED, Basseri RJ, Chong K,  Pimentel M . Abnormal breath testing in IBS: A meta-analysis. Dig Dis Sci 2010;55:2441-9.

 

4. Kunkel, D, Basseri RJ, Makhani MD, Chong K, Chang C,  Pimentel M . Methane on breath testing is associated with constipation: A systematic review and meta-analysis. Dig Dis Sci 2011;56:1612-18.

 

5. Basseri RJ, Basseri B,  Pimentel M , Chong K, Youdim A, Low K, Hwang L, Soffer E, Chang C, Mathur R. Intestinal methane production in obese humans is associated with higher body mass index. In press, Gastroenterol Hepatol, 2012;8:22-28

 

6. Kim G, Deepinder F, Morales W, Hwang L, Weitsman S, Chang C, Gunsalus R,  Pimentel M . Methanobrevibacter smithii is the predominant methanogen in patients with constipation-predominant IBS and methane on breath. Dig Dis Sci 2012;57:3213-8.

 

7. Mathur R, Kim G, Morales W, Weitsman S, Barlow G, Chang C,  Pimentel M . Intestinal Methanobrevibacter smithii  but not Total Bacteria is Related to Diet-Induced Weight Gain in Rats. Obesity 2013;21:748-54.

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Schedule C

 

Stock Issuance Agreement – Synthetic Biologics, Inc.

 

See attached

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Schedule D

 

Stock Issuance Agreement – Licensee

 

 

See attached

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Schedule E

 

Capitalization Table – Licensee

   

Synthetic Biomics, Inc. Capitalization Table (December 4, 2013)
             
Common Stock, par value $0.0001            
50,000,000 shares authorized,            
44,000,000 issued and outstanding   Number Shares     Percent  
      Synthetic Biologics, Inc.     35,200,000       80.0 %
      Cedars-Sinai Medical Center     5,060,000       11.5 %
      Mark Pimentel, M.D.     3,740,000       8.5 %
        Total     44,000,000       100 %

  

See attached

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

  

Schedule F

 

Milestones

  

1. Licensee shall use commercially reasonable efforts, alone or in conjunction with third parties, to commercialize and sell at least one Licensed Product in the Territory.
2. Licensee shall submit an Investigational New Drug application to the FDA for a Licensed Product within two (2) years of the Effective Date.
3. Licensee shall have completed the first Phase I clinical trial for a Licensed Product within three (3) years of the Effective Date.
4. Licensee shall have enrolled the first patient in the first Phase II clinical trial for a Licensed Product within four (4) years of the Effective Date.
5. Licensee shall have completed the first Phase II clinical trial for the first Licensed Product or the first Licensed Technology Product within six (6) years of the Effective Date.
6. Licensee shall have enrolled the first patient in the first Phase III clinical trial for a Licensed Product within eight (8) years of the Effective Date.
7. Licensee shall have completed the first Phase III clinical trial for the first Licensed Product or the first Licensed Technology Product within ten (10) years of the Effective Date.
8. The FDA shall have accepted Licensee’s New Drug Application within fourteen (14) years of the Effective Date.
9. Licensee shall have obtained regulatory approval of the first Licensed Product or the first Licensed Technology Product within fourteen (14) years of the Effective Date.
10. The first commercial sale of the first Licensed Product or the first Licensed Technology Product shall have occurred within fifteen (15) years of the Effective Date.

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

 

Schedule G

 

CLINICAL TRIALS TO BE SPONSORED BY LICENSEE AND CONDUCTED AT CSMC

 

****

 

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Schedule H

Royalty Reporting Form

 

Licensee name:

Reporting period:

Date of report:

Date of first commercial sale:

 

Royalty Report

Licensed
Product or
Licensed
Technology
Product

(list
products by
name)
No. units
sold
Invoiced
price per
unit
Gross
sales
Allowable
deductions
(attached
itemized
detail)
Country of
sale/foreign
currency/
conversion
rate
Net sales
Product name            
Product name            
Product name            
Total            

 

Total net sales $
Royalty rate  
Royalty due $

 

Total royalty due: $___________________________

 

Non-Royalty Sublicense Revenue Report

Total Non-Royalty Sublicense Revenue received $
Date received  
Applicable percentage payable to CSMC  
Total Non-Royalty Sublicense Revenue payable to CSMC $

 

Report prepared by:

Title:

Date:

 

 
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Please send report to:

Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California 90048-1865
Attention: Senior Vice President for Academic Affairs

with a copy to Senior Vice President for Legal Affairs & General Counsel

 

Please send electronic copy to CSTechTransfer@cshs.org .

 

 

Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.  A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

EXCLUSIVE OPTION AGREEMENT

 

This Exclusive Option Agreement (“Agreement”) is entered into this 5th day of December, 2013 (“Effective Date”) by and among Cedars-Sinai Medical Center, a California nonprofit public benefit corporation (“CSMC”), with offices at 8700 Beverly Boulevard, Los Angeles, CA 90048, Synthetic Biologics, Inc. , a Nevada corporation (hereinafter, “Synthetic”), with offices at 617 Detroit Street, Suite 100, Ann Arbor, MI 48104 and Synthetic Biomics, Inc. , a Nevada corporation (hereinafter, “Company”), having offices at 617 Detroit Street, Suite 100, Ann Arbor, MI 48104 and a wholly-owned subsidiary of Synthetic (each, a “Party,” and together, the “Parties”).

 

RECITALS

 

A.            CSMC owns and is entitled to grant license rights with respect to PCT Application No. **** (“Inventors”), and all patents and/or patent applications (including provisional patent applications) existing as of the Effective Date in any other country corresponding to any of the foregoing, and all divisions, continuations, continuations-in-part, reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, and any patent that issues thereon (“Patent Rights”).

 

B.            CSMC desires to have the Patent Rights developed, used and commercialized, and the Parties desire to enter into discussions regarding an exclusive, worldwide license to Company to develop, manufacture, use and sell products utilized or derived from the Patent Rights (“Exclusive License”) pending successful completion by Company of certain limited testing of the technology embodied in the Patent Rights (“Experiments”) described in Appendix A hereto.

 

C.            CSMC desires to grant to Company and Company desires to accept from CSMC, subject to the terms and conditions herein, an exclusive option to negotiate and obtain the Exclusive License. Other than the rights expressly granted by CSMC hereunder, Company acknowledges that CSMC shall retain all other rights with respect to the Patent Rights.

 

D.            CSMC and Company intend that the execution, delivery and performance of this Agreement by each Party, and the consummation of the transactions contemplated hereunder, shall not at any time threaten CSMC’s tax-exempt status under Section 501(c)(3) of the Internal Revenue Code and Section 23701d of the California Revenue and Taxation Code, or cause CSMC to be in default under any of CSMC’s issued and outstanding tax-exempt bonds.

 

Now, Therefore , in consideration of the mutual covenants and premises herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto hereby agree as follows:

 

 

Page 1 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

1. Grant of Option . Except as provided hereinafter and subject to the terms of this Agreement, Company shall have until the expiration of six (6) months from the Effective Date as an exclusive option period (“Option Period”) to notify CSMC of its desire to initiate negotiations for an Exclusive License (“Option Notice”). Company shall have the right to extend the Option Period for an additional six (6) months prior to the expiration thereof by delivering written notice to CSMC (“Extension Notice”), subject to Company’s agreement to pay the non-refundable Extension Fee set forth in Section 3. Upon receipt of the Option Notice within the Option Period, the Parties shall enter into negotiations for the Exclusive License, which the Parties agree shall provide for (a) the payment of an initial License Issue Fee equal to fifty thousand dollars ($50,000) plus reimbursement of CSMC’s patent expenses incurred prior to the effective date of the Exclusive License, such aggregate amount shall be payable in cash or in shares of Synthetic common stock having a market value of 110% of such aggregate amount; provided that such share issuance shall be subject to Section 4 hereof and the terms of the Stock Purchase Agreement of even date herewith entered into by and among the Parties (the “Synthetic Stock Purchase Agreement”); and (b) the same milestone payments, royalties and sublicense fees that are payable under the License Agreement among the Parties of even date herewith (the “Contemporaneous License Agreement”); (c) the “Field of Use” definition set forth in Appendix B hereto; and (d) such other customary terms and conditions as CSMC includes in its licensing arrangements. If an Option Notice is not delivered within the Option Period or the Parties fail to execute an Exclusive License within three (3) months of CSMC’s receipt of an Option Notice, then this Agreement and the exclusive option herein shall terminate, CSMC shall have no further obligation whatsoever to Company with respect to the Patent Rights, and CSMC may freely dispose of the Patent Rights as it sees fit in its own discretion.

 

2. Option Fee . In consideration of the execution and delivery by CSMC of this Agreement, no later than thirty (30) days after the execution of this Agreement, Company shall pay to CSMC a non-refundable fee of Fifty Thousand Dollars ($50,000) (“Option Fee”), payable in cash or in shares of Synthetic common stock having a market value of 110% of such aggregate amount; provided, that such share issuance shall be subject to Section 4 hereof and the terms of the Synthetic Stock Purchase Agreement. Failure of Synthetic either to issue such shares to CSMC or pay the equivalent amount in cash to CSMC within thirty (30) days of the execution of this Agreement shall render this Agreement null and void ( ab initio ).

 

3. Extension Fee . In the event that Company desires to extend the six (6) month Option Period for an additional six (6) months and delivers an Extension Notice to CSMC as set forth in Section 1, Company shall pay to CSMC a non-refundable extension fee of Twenty-Five Thousand Dollars ($25,000) (“Extension Fee”) no later than thirty (30) days after the date of the Extension Notice, payable in cash or in shares of Synthetic common stock having a market value of 110% of such aggregate amount; provided, that such share issuance shall be subject to Section 4 hereof and the terms of the Synthetic Stock Purchase Agreement.

 

Page 2 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

4. Exchange Approval . The Parties acknowledge that subject to Synthetic’s obligations under the Synthetic Stock Purchase Agreement(s), any issuance of stock by Synthetic hereunder may be subject to the prior approval of the NYSE MKT or any other exchange upon which the shares of Synthetic are traded, and shareholder approval, if so required by such exchange or any other rule or regulation applicable to the Company or Synthetic. In the event that Synthetic elects to pay any of the fees and expenses described herein by issuing shares of Synthetic stock to CSMC, Synthetic shall submit an application to the NYSE MKT for approval to issue such shares within the following timeframes: (a) in the case of the option fee described in Section 2 hereof, within five (5) days of the execution of this Agreement; (b) in the case of the extension fee described in Section 3 hereof, within five (5) days of the date of the Company’s Extension Notice; and (c) in the case of the license fee and patent expense reimbursement obligations described in Section 1 hereof, within five (5) days of the execution of the Exclusive License. In the event that Synthetic shall not have received shareholder approval (if required) or NYSE MKT approval to issue any such shares hereunder within fifteen (15) business days of the submission of any such application to the NYSE MKT, then Company shall instead make cash payments in satisfaction of its obligations under Sections 1, 2 and/or 3, as applicable.

 

5. Grant of Limited License . Subject to the terms of this Agreement, CSMC hereby grants to Company, and Company hereby accepts from CSMC, a non-exclusive license to the Patent Rights solely for the purpose of conducting the Experiments. The license granted hereunder is not sublicensable by Company to any third party other than as set forth herein, nor shall it include any other rights not expressly enumerated herein. Company shall have the right to grant a limited sublicense of the rights granted under this Section 5 to Intrexon Corporation (the “Approved Sublicensee”) , who shall be subject in all respects to the provisions contained in this Agreement, and Company will remain primarily liable to CSMC for, and shall be responsible for monitoring and enforcing, the performance of all of Company’s obligations hereunder by the Approved Sublicensee.

 

6. Limited Warranty . CSMC makes no representation or warranty other than those expressly specified in this Agreement. For purposes of Section 5, Company accepts the Patent Rights on an “AS-IS” basis. CSMC MAKES NO EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR OTHER ATTRIBUTES OF ANY OF THE PATENT RIGHTS.

 

7. Guarantee of Company’s Performance . Synthetic hereby unconditionally guarantees to CSMC the full and complete performance of all of the terms, covenants and conditions of this Agreement as required to be performed by Company, including, but not limited to, the payment of all amounts due hereunder.

 

Page 3 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

8. Indemnification . Company shall hold harmless, defend and indemnify CSMC and each of its officers, directors, employees and agents and each Inventor (each, an “Indemnified Party”, and collectively, the “Indemnified Parties”) from and against any and all claims, damages, losses, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses and costs of investigation, whether or not suit is filed) suffered or incurred by any of the Indemnified Parties in any action, suit, litigation, arbitration or dispute of any kind (“Action”) arising or resulting from any negligence or willful acts or omissions on the part of Company and/or its Approved Sublicensee in connection with this Agreement, including without limitation: (a) its use of the Patent Rights under this Agreement, (b) the design or conduct of the Experiments and/or (c) the exercise of its rights hereunder. As part of its obligations hereunder, Company shall defend any Action brought against any of the Indemnified Parties with counsel of its own choosing and reasonably acceptable to CSMC, and neither CSMC nor any other Indemnified Party shall enter into any settlement of any such Action without first obtaining prior approval of Company. Should CSMC or any other Indemnified Party not afford Company the right to defend any such Action, or should CSMC or any other Indemnified Party not obtain the approval of Company to any such settlement, Company shall have no obligation to indemnify CSMC or any other Indemnified Party hereunder. Should Company fail to provide a defense for the Indemnified Parties as required hereunder, then Company shall reimburse CSMC for its out-of-pocket expenses (including reasonable attorneys’ fees and expenses and costs of investigation) which are incurred as a result of any investigation, defense or settlement relating to an indemnified matter, which reimbursement shall be made to CSMC upon receipt by Company of invoices reflecting in reasonable detail such expenses incurred by CSMC. Company shall obtain and maintain insurance policies or a program of self-insurance (including products liability and general liability policies at such time as is appropriate) which are reasonable and necessary to cover its activities and to comply with the indemnification obligations set forth above. CSMC shall promptly notify Company in writing of any claim or Action or material threat thereof brought against any Indemnified Party in respect of which indemnification may be sought and, to the extent allowed by law, shall reasonably cooperate with Company in defending or settling any such claim or Action.

 

9. Prosecution Costs . CSMC will prepare, file, prosecute and maintain the Patent Rights during the Option Period. The Exclusive License shall provide that (a) Company will reimburse CSMC for the costs and expenses, including reasonable attorneys’ fees, filing fees and translation fees (“Prosecution Costs”), actually incurred by CSMC in the prosecution of any Patent Rights prior to and during the Option Period and through the effective date of the Exclusive License; and (b) CSMC will continue to have full responsibility for patent prosecution; provided, however, that CSMC’s patent counsel shall bill Company directly for all Prosecution Costs related to the Patent Rights following the effective date of the Exclusive License. If Company desires any foreign filings to be pursued on the Patent Rights during the Option Period, Company shall be responsible for the Prosecution Costs related to any such foreign filings, regardless of whether the Option is exercised.

 

10. Use of Names . Company shall not make any written use of or reference to the name of CSMC and/or any of its trademarks, service marks, trade names or fictitious business names without the prior written consent of CSMC, which consent may be withheld or granted in CSMC’s sole and absolute discretion, unless required by law. Further, prior to any reference by Company to the names or marks of CSMC in any manner, Company shall provide CSMC with a writing reflecting the proposed reference so that CSMC can review the reference within a reasonable period of time prior to the proposed use thereof by Company. This limitation includes, but is not limited to, use by Company in any regulatory filing, advertising, offering circular, prospectus, sales presentation, news release or trade publication, unless required by law, and provided, however, that certain specific language shall be mutually agreed upon by the Parties for Company’s use in certain contexts and with respect to certain topics, and once agreed upon, may be utilized by Company in connection with the approved contexts and topics without further permission of CSMC.

 

Page 4 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

11. Confidentiality . The terms of this Agreement and any information disclosed by either Party hereunder shall be maintained in the strictest of confidence by the Parties hereto and their respective officers, directors, employees and agents, including any proprietary, non-public information designated as such and disclosed by one Party to the other in connection with the transactions proposed in this Agreement. Furthermore, the Patent Rights are understood by Company to be the Confidential Information of CSMC to the extent “unpublished” as such term is construed under the United States Patent Laws. As such, Company’s confidentiality obligations hereunder automatically extend to any and all patent applications of CSMC relating to any Patent Rights. Company shall have no right to share the Confidential Information with any third party other than the Approved Sublicensee; provided , however, that (a) the Approved Sublicensee shall have entered into a confidentiality agreement with Company that provides the same standard of protection described in this Agreement; and (b) Company shall be fully responsible and liable for any action of the Approved Sublicensee which would constitute a breach of this Agreement if committed by Company as if Company had committed such action itself.  Any public announcements, notices or other communications regarding such matters to third parties, other than the Parties’ respective professional advisors or potential investors or business partners, including, without limitation, any disclosure regarding the transactions contemplated hereby, shall require the prior written approval of both Company and CSMC. Notwithstanding anything to the contrary set forth in this Section 11, the Parties acknowledge that Synthetic may be obligated to file a copy of this Agreement, any Schedules hereto, and summaries of the terms hereof with the U.S. Securities and Exchange Commission as reasonably required to comply with applicable laws or the rules of a nationally-recognized securities exchange. Synthetic shall be entitled to make such filings, provided that it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available. In the event of any such filing, Synthetic will provide CSMC with a copy of this Agreement (including the Schedules hereto) and related filings marked to show provisions for which Synthetic intends to seek confidential treatment and shall reasonably consider and incorporate CSMC’s comments thereon to the extent consistent with the legal requirements and the rules of any nationally recognized securities exchange governing disclosure of material agreements and material information to be publicly filed.

 

12. Notices . Any notice, request, instruction or other document required by this Agreement, including the Option Notice, shall be in writing and shall be deemed to have been given: (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient, (b) if sent by Federal Express®, Airborne®, or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient, or (c) if sent by facsimile transmission, when so sent and when receipt has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:

 

Page 5 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

in the case of CSMC, to:

 

Cedars-Sinai Medical Center

Room 2009, North Tower

8700 Beverly Boulevard

Los Angeles, CA 90048-1865

Attention: Senior Vice President for Academic Affairs & Dean of the Medical Faculty

Fax: (310) 423-0119

 

Copy to: Vice President for Legal Affairs

 

or in the case of Company, to:

 

Chief Executive Officer

Synthetic Biologics, Inc.

617 Detroit Street, Suite 100

Attention: Jeffery Riley

Fax: (734) 332-7878

 

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 12.

 

13. Miscellaneous .

 

a. Compliance with Laws . Each Party shall comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this Agreement.

 

b. Governing Law . This Agreement shall be construed and enforced in accordance with the laws of the United States of America and of the State of California, irrespective of choice of laws provisions.

 

c. Waiver . Failure of any Party to enforce a right under this Agreement shall not act as a waiver of that right or the ability to assert that right relative to the particular situation involved.

 

d. Enforceability . If any provision of this Agreement shall be found by a court of competent jurisdiction to be void, invalid or unenforceable, the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or enforceability of the remainder of this Agreement.

 

Page 6 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

e. Modification . No change, modification, or addition or amendment to this Agreement, or waiver of any term or condition of this Agreement, is valid or enforceable unless in writing and signed and dated by the authorized officers of the Parties to this Agreement.

 

f. Entire Agreement . This Agreement and the Confidentiality Agreement currently in effect between CSMC and Synthetic constitute the entire agreements among the Parties with respect to the subject matter hereof and thereof, and replace and supersede as of the date hereof and thereof any and all prior agreements and understandings, whether oral or written, among the Parties with respect to the subject matter of such agreements.

 

g. Construction . This Agreement has been prepared, examined, negotiated and revised by each Party and their respective attorneys, and no implication shall be drawn and no provision shall be construed against any Party to this Agreement by virtue of the purported identity of the drafter of this Agreement or any portion thereof.

 

h. Counterparts . This Agreement may be executed simultaneously in one or more counterparts, each of which shall constitute one and the same instrument. This Agreement may be executed by facsimile.

 

i. Assignment . Except as otherwise expressly provided in this Agreement, this Agreement shall be binding upon, inures to the benefit of, and is enforceable by, the Parties and their respective heirs, legal representatives, successors and permitted assigns. This Agreement shall not be assignable by Company absent the prior written consent of CSMC unless to a successor to Company or a purchaser of all or substantially all of the assets of Company relating to the subject matter of this Agreement. Synthetic shall have no right to assign this Agreement.

 

j. Further Assurances . At any time and from time to time after the Effective Date, each Party shall do, execute, acknowledge and deliver, and cause to be done, executed, acknowledged or delivered, all such further acts, transfers, conveyances, assignments or assurances as may be reasonably required to consummate the transactions contemplated by this Agreement.

 

k. Survival . The following sections shall survive any expiration or earlier termination of this Agreement: Section 6 (“Limited Warranty”), Section 8 (“Indemnification”), and Section 10 (“Use of Names”).

 

Page 7 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute this Agreement as of the Effective Date.

 

“CSMC”:

 

Cedars-Sinai Medical Center,
a California nonprofit public

benefit corporation

 

By: /s/ Shlomo Melmed, M.D.  
  Shlomo Melmed, M.D.  
  Senior Vice President for Academic Affairs  
  & Dean of the Medical Faculty  
     
By: /s/ Edward M. Prunchunas  
  Edward M. Prunchunas  
  Senior Vice President for Finance & CFO  

  

“Company”:
Synthetic Biomics, Inc.,
a nevada corporation

 

By: /s/ Steve Kanzer  
Name: Steve Kanzer  
Title:

CEO & President

 
   
“Synthetic”:  
Synthetic Biologics, Inc.,  
a nevada corporation  
   
By:

/s/ Jeff Riley

 
Name:

Jeff Riley

 
Title: CEO  

 

Page 8 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

 

Appendix A

 

Experiments

 

 

****

 

 

Page 9 of 10
Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Appendix B

 

“Field of Use” Definition for Exclusive License

 

All human or veterinary therapeutic and prophylactic applications, excluding the following:

 

1. the therapeutic use of rifaximin;

 

2. the therapeutic use of any of the following, as each is more fully described in U.S. Patent No. 6,558,708: (A) active lipids, (B) serotonin, serotonin agonists, or serotonin re-uptake inhibitors, (C) peptide YY or peptide YY functional analogs, (D) calcitonin gene-related peptide or functional analogs thereof, (E) adrenergic agonists, (F) opioid agonists, (G) combinations of any of (A), (B), (C), (D), (E) and/or (F); and (H) antagonists of receptors for any of (B), (C), (D), (E) and/or (F));

 

3. the diagnosis, prognosis, or the testing of, or the provision of information to clinicians or patients regarding, small intestinal bacterial overgrowth (SIBO), and/or conditions or disorders related thereto in human subjects, using breath testing products or breath testing services to detect SIBO or SIBO-related conditions (provided, however, that methods of utilizing such diagnostic information for the selection of one or more particular therapeutic regimens shall not be excluded); and

 

4. the use of small molecules and/or agonists and antagonists of vinculin.

 

Page 10 of 10

 

 

STOCK PURCHASE AGREEMENT

 

by and among

 

SYNTHETIC BIOLOGICS, INC.,

 

SYNTHETIC BIOMICS, INC.

 

and

 

CEDARS-SINAI MEDICAL CENTER, INC.

 

December 5, 2013

 

 
 

 

STOCK PURCHASE AGREEMENT

 

THIS AGREEMENT (“ Agreement ”) is made and entered into as of December 5, 2013 (the “ Effective Date ”), by and among Synthetic Biologics, Inc., a Nevada corporation (the “ Company ”), Synthetic Biomics, Inc., a Nevada corporation and wholly owned subsidiary of the Company (“ Licensee ”) and Cedars-Sinai Medical Center, a California nonprofit public benefit corporation (“ CSMC ”).

 

A.            Concurrently with the execution of this Agreement, the Company and the Licensee are entering into a license agreement with CSMC (the “ License Agreement ”) and an option agreement with CSMC (the “ Option Agreement ”, and, together with the License Agreement, the “ Agreements ”), pursuant to which CSMC is licensing and optioning the rights to certain technology to Licensee; and

 

B.            In partial consideration of the license and the option under the Agreements, the Company and the Licensee have agreed to issue to CSMC certain shares of the Company’s common stock in accordance with the terms and conditions of this Agreement and may issue additional shares of Company stock in lieu of cash (a) upon the occurrence of certain milestone events described in the License Agreement and (b) with respect to the payment of certain fees and expenses as required by the Option Agreement.

 

AGREEMENT

 

In consideration of the mutual covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Company and CSMC hereby agree as follows:

 

sECTION 1.  AUTHORIZATION OF ISSUANCES OF SHARES .

 

1.1 Authorization . Subject to the terms and conditions of this Agreement, the Company has authorized and intends to issue to CSMC shares of common stock, $0.001 par value, of Company (the “ Common Stock ”) immediately following approval of the NYSE MKT regarding the issuance of such shares and no later than thirty (30) days following the execution of the License Agreement and the Option Agreement in satisfaction of the following obligations: (a) the license issue fee and patent expense reimbursement obligations under Sections 4.1 and 4.2 of the License Agreement, and (b) the option fee obligation under Section 2 of the Option Agreement, and may, at the option of the Company and the Licensee, authorize and issue to CSMC additional shares of Common Stock, $0.001 par value of the Company, in lieu of cash in satisfaction of the following obligations: (x) the Phase I and Phase II milestone payment obligations described in Section 4.6(e)(ii) of the License Agreement, (y) the extension fee obligation under Section 3 of the Option Agreement, and (z) the obligation to pay an initial license issuance fee and to reimburse CSMC for its patent expenses in the event that the Licensee and CSMC execute an exclusive license to the technologies covered by the Option Agreement (together, the “ Shares ”).

 

 
 

 

1.2            Exchange Approval . The parties acknowledge that any issuance by the Company of its common stock described in Section 1.1 is subject to the prior approval of the NYSE MKT or any other exchange upon which the shares of the Company are listed and shareholder approval, if so required by such exchange or any other rule or regulation applicable to the Licensee or the Company. In the event that the Company shall not have received shareholder approval (if required) or NYSE MKT approval to issue any shares hereunder within fifteen (15) business days of such application to the NYSE MKT, then the Company shall instead make cash payments in satisfaction of (a) the license issue fee and patent reimbursement expense obligations under Sections 4.1 and 4.2 of the License Agreement; (b) Phase I and Phase II milestone payment obligations described in Section 4.6(e)(ii) of the License Agreement; (c) the option fee obligation under Section 2 of the Option Agreement; (d) the extension fee obligation under Section 3 of the Option Agreement, and (e) the license issuance fee and patent expense reimbursement obligations in the event that the Licensee and CSMC execute an exclusive license to the technologies covered by the Option Agreement, as set forth in Section 1 of the Option Agreement.

 

sECTION 2.  CLOSING AND DELIVERY

 

2.1            Issuance of Shares . Subject to the terms and conditions of this Agreement and in reliance upon the representations, warranties and agreements contained herein, at each Closing (as such term is defined in Section 2.2), the Company will issue to CSMC, and CSMC will acquire from the Company, the Shares.

 

2.2            Closings . The closings of the issuances of the Shares hereunder shall be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26 th Floor, New York, New York 10174 or at such other place as the Company and CSMC may agree (a) with respect to the Shares issued under Sections 4.1 and 4.2 of the License Agreement and Section 2 of the Option Agreement, within two (2) business days following approval of the NYSE MKT with respect to such issuance or simultaneously with the execution of this Agreement, whichever is later, and (b) with respect to the Shares that may be issued to CSMC under Sections 1 and 3 of the Option Agreement and in satisfaction of the Phase I and Phase II milestone payment obligations described in Section 4.6(e)(ii) of the License Agreement, within two (2) business days following approval of the NYSE MKT with respect to each such stock issuance(the “ Closings ”). At each Closing, the Company and the Licensee agree to deliver to CSMC a certificate signed by the Company’s Chief Executive Officer on behalf of the Company, dated as of the applicable Closing, certifying that each of the representations and warranties of the Company and the Licensee in this Agreement shall be true and correct as of the date of the applicable Closing, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date. Furthermore, at each Closing, CSMC agrees to deliver to the Company a certificate signed by an authorized officer on behalf of CSMC, dated as of the applicable Closing, certifying that each of the representations and warranties of CSMC in this Agreement shall be true and correct as of the date of the applicable Closing, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date.

 

 
 

 

2.3            Calculation of Number of Shares to be Issued . The number of shares to be issued at each Closing shall be determined (a) in the case of amounts due under Sections 4.1 and 4.2 of the License Agreement and Section 2 of the Option Agreement, by dividing such cash amounts (in the case of the amount due under Section 2 of the Option Agreement, such cash amount shall be $55,000) by the average closing price of the Common Stock as quoted by the NYSE MKT for the ten (10) trading days immediately preceding the execution of the License Agreement and the Option Agreement, (b) in the case of amounts due in satisfaction of the Company’s Phase I and Phase II milestone payment obligations described in Section 4.6(e)(ii) of the License Agreement, by dividing the applicable cash amounts (in the case of the Phase I milestone payment, such cash amount shall be $110,000, and in the case of the Phase II milestone payment, such cash amount shall be $275,000) by the average closing price of the of the Common Stock as quoted by the NYSE MKT for the ten (10) trading days immediately preceding the date of the event giving rise to such milestone payment, (c) in the case of the amount due under Section 3 of the Option Agreement, by dividing such cash amount (such cash amount shall be $27,500) by the average closing price of the Common Stock as quoted by the NYSE MKT for the ten (10) trading days immediately preceding the date of the Licensee’s written notice to CSMC of its intent to extend the option period, and (d) in the case of amounts due under Section 1 of the Option Agreement, by dividing such cash amounts (such cash amounts shall be 110% of the aggregate amount due under Section 1) by the average closing price of the Common Stock as quoted by the NYSE MKT for the ten (10) trading days immediately preceding the execution of the exclusive license agreement for the technologies covered by the Option Agreement.

 

2.4            Delivery of the Shares . At each Closing, the Company shall cause to be delivered to CSMC a certificate representing the number of Shares issued hereunder, registered in the name of CSMC.

 

sECTION 3.  REPRESENTATIONS AND WARRANTIES OF THE COMPANY AND THE LICENSEE .

 

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 Nevada 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 Licensee is a corporation wholly owned by the Company and duly incorporated, validly existing and in good standing under the laws of the State of Nevada with the requisite corporate power to own, lease and operate its properties and assets and to conduct its business as it is now being conducted. Other than the Licensee and those subsidiaries identified in its most recent report on Form 10-Q, the Company does not have any subsidiaries. Each of the Company and the Licensee 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 or the Licensee, as applicable, that is material and adverse to the Company or the Licensee, as applicable, taken as a whole, and any condition, circumstance or situation that would prohibit the Company or the Licensee, as applicable, from entering into and performing any of its obligations hereunder.

 

 
 

 

3.2            Authorization; Enforcement . Each of the Company and the Licensee has the requisite corporate power and authority to enter into and perform this Agreement and the Company has the requisite power and authority to issue and sell the Shares in accordance with the terms hereof. The execution, delivery and performance of this Agreement by the Company and the Licensee and the consummation by each of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action, and no further consent or authorization of the Licensee, the Company, either of its board of directors or stockholders is required for the issuance of the Shares or the consummation of the transactions contemplated hereby. When executed and delivered by the Company and the Licensee, this Agreement shall constitute a valid and binding obligation of the Company and the Licensee enforceable against each 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, creditor’s rights and remedies or by other equitable principles of general application.

 

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, when issued 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 and rights of first refusal of any kind imposed by the Licensee or the Company, as applicable (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. As of the date hereof, 44,654,414 shares of Company Stock are issued and outstanding.

 

3.4            No Conflicts; Governmental Approvals . The execution, delivery and performance of the Agreement by the Company and the Licensee and the consummation by the Company and the Licensee of the transactions contemplated hereby do not and will not: (i) violate any provision of the Company’s or the Licensee’s 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 or the Licensee is a party or by which the Company’s or the Licensee’s 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 the Licensee or by which any property or asset of the Company or the Licensee 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. Neither the Company nor the Licensee is 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 the Shares in accordance with the terms hereof (other than any filings, consents and approvals required to be made by the Company or the Licensee under applicable state and federal securities laws, securities and exchange commission rules or regulations, rules or regulations of any stock exchange upon which shares of common stock of the Company may be listed or rules or regulations prior to or subsequent to the date hereof).

 

 
 

 

3.5            SEC Documents, Financial Statements . The Company Stock is registered pursuant to Section 12(b) of the Exchange Act. During the two year period preceding the execution of 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 (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 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, other than with respect to its initial Annual Report on Form 10-K for the year ended December 31, 2011 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            Brokers . Neither the Company, the Licensee nor any of the officers, directors or employees of the Company or the Licensee has employed any broker or finder in connection with the transaction contemplated by this Agreement

 

sECTION 4.  REPRESENTATIONS, WARRANTIES AND COVENANTS OF CSMC .

 

4.1            Purchaser Sophistication . CSMC represents and warrants to, and covenants with, the Company and the Licensee that CSMC: (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 purchase of the Shares, 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) CSMC, in connection with its decision to purchase the Shares, relied only upon the documents of the Company filed with the Securities and Exchange Commission, other publicly available information, and the representations and warranties of the Company and the Licensee contained herein. CSMC is an " accredited investor " pursuant to Rule 501 of Regulation D under the Securities Act; (c) CSMC 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) CSMC has not been organized, reorganized or recapitalized specifically for the purpose of investing in the Shares; (e) CSMC 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 of 1933 and applicable state securities laws; (f) CSMC understands that the Shares are being offered and sold to it in reliance upon specific exemptions from the registration requirements of the Securities Act of 1933 and state securities laws, and that the Company and the Licensee are relying upon the truth and accuracy of, and CSMC’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of CSMC set forth herein in order to determine the availability of such exemptions and the eligibility of CSMC to acquire the Shares; (g) CSMC understands that its investment in the Shares involves a significant degree of risk, including a risk of total loss of CSMC’s investment; and (h) CSMC 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 . CSMC has the requisite power and authority to enter into and perform this Agreement and to purchase the Shares being sold to it hereunder. The execution, delivery and performance of this Agreement by CSMC 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 CSMC or its board of directors or stockholders is required. When executed and delivered by CSMC, this Agreement shall constitute a valid and binding obligation of CSMC enforceable against CSMC 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, creditor’s rights and remedies or by other equitable principles of general application.

 

4.3            No Conflict . The execution, delivery and performance of this Agreement by CSMC and the consummation by CSMC of the transactions contemplated hereby do not and will not: (i) violate any provision of CSMC’s 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 CSMC is a party or by which CSMC’s 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 CSMC or by which any property or asset of CSMC 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 CSMC’s ability to perform its obligations under the Agreement.

 

4.4            Restricted Shares . CSMC acknowledges that the Shares are restricted securities and subject to Section 6.2, must be held indefinitely unless subsequently registered under the Securities Act of 1933 or the Company receives an opinion of counsel reasonably satisfactory to the Company that such registration is not required.

 

4.5            Stock Legends . CSMC acknowledges that certificates evidencing the Shares shall bear a restrictive legend in substantially the following form (and including related stock transfer instructions and record notations):

 

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.

 

 
 

 

sECTION 5.  SURVIVAL OF REPRESENTATIONS, WARRANTIES AND AGREEMENTS .

 

Notwithstanding any investigation made by any party to this Agreement, all representations and warranties made by the Company, the Licensee and CSMC herein shall survive the execution of this Agreement and the issuance and sale to CSMC of the Shares.

 

sECTION 6.  COVENANTS .

 

6.1            In each case where the Company determines that the approval of the Company’s shareholders or any exchange or other listing upon which the Shares may be listed is required for the issuance of the Shares to CSMC, the Company shall use commercially reasonable efforts to secure such approval as promptly as possible.

 

6.2            Upon request of CSMC, the Company agrees to provide an opinion of counsel to its transfer agent regarding the removal of the legend on the Shares issued to CSMC hereunder; provided that all legal requirements allowing for such legend removal and all applicable conditions under Rule 144 promulgated under the Securities Act of 1933 are met.

 

sECTION 7.  NOTICES.

 

All notices or other communications which are required or permitted hereunder shall be in writing and addressed as follows:

 

If to the Company or the Licensee: Synthetic Biologics, Inc.
  155 Gibbs Street, Suite 412
  Rockville, MD 20850
  Fax No.:   (734) 332-7878
   
If to CSMC: Cedars- Sinai Medical Center
  8700 Beverly Boulevard
  West Hollywood, CA 90048-1865
  Attn:  Senior Vice President for Academic Affairs
   
With a copy to: Senior Vice President for Legal Affairs & General Counsel

 

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 8.  MISCELLANEOUS .

 

8.1            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.

 

 
 

 

8.2            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.

 

8.3            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.

 

8.4            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.

 

8.5            Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of California as applied to contracts entered into and performed entirely in the State of California, without regard to conflicts of law principles.

 

8.6            Counterparts . This Agreement may be executed in two or more counterparts, 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.

 

8.7            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 CSMC shall not assign its rights or obligations hereunder and the Licensee shall only be able to assign its tights or obligations hereunder to an affiliated entity if the License Agreement is also assigned to such entity.

 

8.8            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.

 

8.9            Expenses . Each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement.

 

8.10          Entire Agreement . This Agreement (including the Schedule of Exceptions), License Agreement and other documents 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.

 

8.11          Publicity . Except as otherwise provided herein, 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.

 

 
 

 

8.12          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.

 

8.13          Further Assurances . From and after the date of this Agreement, upon the reasonable request of CSMC or the Company, the Company and CSMC shall execute and deliver such instruments, documents and other writings as may be reasonably necessary or desirable to confirm and carry out and to effectuate fully the intent and purposes of this Agreement.

 

[Remainder of page intentionally left blank.]

 

 
 

 

IN WITNESS WHEREOF , the parties hereto have caused this Stock Purchase Agreement to be executed by their duly authorized representatives as of the day and year first above written.

 

  SYNTHETIC BIOLOGICS, INC.
     
  By: /s/ Steve Kanzer
  Name:

Steve Kanzer

  Title:

CEO & President

 

  SYNTHETIC BIOLOGICS, INC.
     
  By:          /s/ Jeff Riley
  Name: Jeff Riley
  Title:

CEO

 

 

  CEDARS-SINAI MEDICAL CENTER
     
  By: /s/ Shlomo Melmed, M.D.
  Name: Shlomo Melmed, M.D.
  Title: Senior Vice President for Academic Affairs & Dean of the Medical Faculty
     
  By: /s/ Edward M. Prunchunas
  Name: Edward M. Prunchunas
  Title: Senior Vice President for Finance & CFO

 

 

 

 

STOCK PURCHASE AGREEMENT

 

THIS AGREEMENT (this “ Agreement ”) is made and entered into as of December 3, 2013 (the “ Effective Date ”), by and among Synthetic Biologics, Inc., a Nevada corporation (the “ Company ”), Synthetic Biomics, Inc., a Nevada corporation and wholly-owned subsidiary of the Company (“ Synbiomics ”), and Mark Pimentel, M.D., an individual (“ Pimentel ”).

 

A.            The Company and Synbiomics may (or may not) enter into license and option agreements with Pimentel (the “ License Agreement ”), pursuant to which Pimentel may license and option the rights to certain technology to Synbiomics; and

 

B.            In advance of such potential License Agreement (which may or may not be entered into), Synbiomics has agreed to issue to Pimentel certain shares of Synbiomics’ common stock in exchange for $0.0001 per share (“ Common Stock ”), accordance with the terms and conditions of this Agreement.

 

AGREEMENT

 

In consideration of the mutual covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

 

sECTION 1.          AUTHORIZATION OF SALE OF SHARES ; ANTI-DILUTION; EXCHANGE OF SHARES.

 

1.1            Authorization . Subject to the terms and conditions of this Agreement, Synbiomics has duly authorized the issuance to Pimentel of Three Million Seven Hundred Forty Thousand (3,740,000) shares of Common Stock (such shares, together with any Additional Shares issued in accordance with Section 1.2, the “ Shares ”) in exchange for Three Hundred and Seventy Four Dollars ($374.00) payable immediately by cash or check, which shares shall represent eight and one-half percent (8.5%) of the shares of Synbiomics’ issued and outstanding capital stock on a Fully-Diluted Basis on the Effective Date. For purposes of this Agreement, the term “ Fully Diluted Basis ” shall include all of the issued and outstanding equity securities of Synbiomics (including, without limitation, all common stock, preferred stock and units of any kind) calculated on an “as-converted” basis plus all outstanding options, warrants and other securities exercisable or exchangeable for or convertible into equity securities of Synbiomics calculated on an “as-converted” basis plus any securities issued under any stock plan or other equity incentive plan or arrangement of Company then in effect or contemplated calculated on an “as-converted” basis.

 

 
 

  

1.2           Anti-Dilution Protection . Until such time as Synbiomics has received an aggregate of at least Three Million Dollars ($3,000,000) in cash proceeds from one or more investors in a bona fide equity financing transaction, including financing received from the Company (the “ Funding Threshold ”), Pimentel and its affiliates shall continue to own not less than eight and one-half percent (8.5%) of the shares of Synbiomics’ issued and outstanding capital stock on a Fully-Diluted Basis (or such lesser percentage if Pimentel shall sell or transfer any of the Shares to any person or entity other than an affiliate, the “ Percentage Interest ”). To the extent any security, including any security convertible into or exercisable for shares of capital stock of Synbiomics, is issued to any entity or person that would cause Pimentel’s equity ownership to fall below the Percentage Interest calculated on a Fully-Diluted Basis prior to the Synbiomics’ achievement of the Funding Threshold, then Pimentel may request that Synbiomics shall issue to Pimentel a new stock certificate in exchange for the prior certificate, without further consideration from Pimentel, with such new certificate representing a number of shares of Common Stock in an amount sufficient to maintain the Percentage Interest calculated on a Fully Diluted Basis through the achievement of the Funding Threshold (the “ Additional Shares ”). Not later than five (5) business days after the consummation of any transaction triggering the issuance of Additional Shares, Synbiomics shall cause to be delivered to Pimentel a written notice thereof. Each of the representations and warranties of the Company and Synbiomics in this Agreement shall be true and correct as of the date of any issuance of the Additional Shares, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date.

 

1.3           Exchange of Shares .

 

(a)           As of the 18-month anniversary of the Effective Date, if the Shares are not then freely tradeable, Pimentel shall have the right to exchange up to fifty percent (50%) of the Shares then held by Pimentel (such shares, the “ Initial Exchange Shares ”) for shares of common stock, $0.001 par value, of the Company (“ Company Stock ”) pursuant to the terms set forth in this Section 1.3 by delivering a written notice to the Company (the “ First Exchange Notice ”) at least ninety (90) days prior to the 18-month anniversary of the Effective Date. The right of Pimentel to exchange the Initial Exchange Shares is referred to as the “ First Exchange Right .” The number of shares of Company Stock for which the Initial Exchange Shares may be exchanged shall equal the quotient obtained by dividing (i) the aggregate Fair Market Value of the Initial Exchange Shares to be exchanged as determined in accordance with Section 1.3(e) below by (ii) the Current Market Price of a single share of Company Stock as determined in accordance with Section 1.3(f) below. The parties intend to exchange the Initial Exchange Shares for Company Stock pursuant to one (1) Exchange Closing transaction.

 

(b)           As of the 36-month anniversary of the Effective Date, if the Shares are not then freely tradeable, Pimentel shall have the right to exchange up to the number of Shares then held by Pimentel excluding any Initial Exchange Shares (whether or not exchanged pursuant to this Section 1.3) (the “ Remaining Exchange Shares ”) for shares of Company Stock pursuant to the terms of this Section 1.3 by delivering a written notice to the Company (the “ Second Exchange Notice ”) at least ninety (90) days prior to the 36-month anniversary of the Effective Date. The right of Pimentel to exchange the Remaining Exchange Shares is referred to as the “ Second Exchange Right .” The number of shares of Company Stock for which the Remaining Exchange Shares may be exchanged shall equal the quotient obtained by dividing (i) the aggregate Fair Market Value of the Remaining Exchange Shares to be exchanged as determined in accordance with Section 1.3(e) below by (ii) the Current Market Price of a single share of Company Stock as determined in accordance with Section 1.3(f) below. The parties intend to exchange the Remaining Exchange Shares for Company Stock pursuant to one (1) Exchange Closing transaction.

 

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(c)           Unless the parties involved mutually agree otherwise, delivery to the Company of the share certificates representing the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, to be exchanged pursuant to this Section 1.3 shall take place at a closing (each, an “ Exchange Closing ”) to be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26th Floor, New York, New York 10174 or at such other place as the Company and Pimentel may agree at 10:00 a.m. within two (2) calendar days following approval of the NYSE MKT with respect to such issuance. The Company shall promptly apply to the NYSE MKT for approval of the issuance of the shares of Company Stock after the determination of the applicable Fair Market Value for the Initial Exchange Shares or the Remaining Exchange Shares to be exchanged pursuant to this Section 1.3. Immediately prior to the transfer of title to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, to be exchanged at an Exchange Closing and issuance of Company Stock, Pimentel shall provide the representations and warranties set forth in this Agreement as well as representations and warranties as to Pimentel’s good and marketable title to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, and the absence of any liens, security interests or adverse claims of any kind arising by, through or under such Pimentel, all as of a recent date. It shall be a condition to Pimentel’s transfer of title to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, to be exchanged at an Exchange Closing that each of the representations and warranties of the Company and Synbiomics in this Agreement shall be true and correct as of the date of the applicable Exchange Closing, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date, and the Company shall deliver to Pimentel a certificate signed by its Chief Executive Officer on behalf of the Company, dated as of the applicable Exchange Closing, certifying that such condition has been satisfied. Pimentel agrees that as a condition to its receipt of any Company Stock pursuant to the terms of this Section 3 that it will enter into a customary “lockup” or “market standoff” agreement with a term no longer than four (4) months in a form reasonably satisfactory to the Company, and such agreement shall include customary exceptions including for transfers to affiliates.

 

(d)           No fractional shares or scrip representing fractional shares shall be issued upon the exchange of any Shares pursuant to this Section 1.3. As to any fraction of a share which Pimentel would otherwise be entitled to purchase upon such exchange, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Current Market Price of a share of Company Stock or round up to the next whole share.

 

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(e)           The “ Fair Market Value ” of the Initial Exchange Shares and the Remaining Exchange Shares shall be determined based primarily upon the relative contribution of the valuation of Synbiomics to the public market capitalization of Company and as provided in this Section 1.3(e). Upon the Company’s receipt of the First Exchange Notice or the Second Exchange Notice, as applicable, Pimentel and the Company shall forthwith attempt to agree upon the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable. If Pimentel and the Company cannot agree on the Fair Market Value of the Initial Shares or the Remaining Exchange Shares, as applicable, within ten (10) days of the Company’s receipt of the First Exchange Notice or the Second Exchange Notice, as applicable, then Pimentel and the Company shall, within ten (10) days of the end of such initial 10-day period (such period, the “ Mutual Selection Period ”), choose one mutually acceptable qualified independent appraiser to determine the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, and such appraiser shall deliver its written appraisal within twenty (20) days of the date of its selection and the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, shall be as set forth in such appraisal. If Pimentel and the Company cannot agree on a mutually acceptable qualified independent appraiser within the Mutual Selection Period, then each of Pimentel and the Company shall select a qualified independent appraiser to determine the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, within five (5) days after the end of the Mutual Selection Period. The appraisers so selected shall attempt to agree to the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable.  If they are unable to do so within twenty (20) days of the date of selection of the last of the appraisers selected, they shall furnish each party with their respective written appraisals within thirty (30) days of the date of selection of the last of the appraisers selected, which written appraisals shall set forth the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable.  If each valuation is within ten percent (10%) of the other valuation, the Fair Market Value shall be the numerical average (mean) of both valuations.  If each valuation is not within ten percent (10%) of the other valuation, then the two appraisers, within ten (10) days after submitting their respective valuations, shall mutually select and appoint a third appraiser, similarly qualified, and give written notice of that appointment to the Company and Pimentel.  Within thirty (30) days after the appointment of the third appraiser, the third appraiser shall submit in writing its determination of the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable.  Thereafter, the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, shall be the numerical average (mean) of the two (2) valuations which are numerically closest together, unless one of the values is the numerical average (mean) of the three (3) values, in which case such value shall be the Fair Market Value. The Fair Market Value, as determined above, shall be conclusive, final and binding upon the Company and Pimentel.  If either the Company or Pimentel shall fail to appoint an appraiser within five (5) days after the end of the Mutual Selection Period referred to above, then, the appraiser appointed by the party which does appoint an appraiser shall alone determine the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, and such appraisal shall be binding. Any appraiser appointed in accordance with this Section 1.3(d) shall value Synbiomics as a going concern and shall not apply any illiquidity and minority discount to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable. Each party shall compensate the appraiser appointed by such party, and the compensation of the first, mutually acceptable appraiser and the third appraiser, if any, and the expenses of the appraisal shall be borne equally by the Company and Pimentel. Company shall have no lost opportunity liability to Pimentel for Pimentel’s decision to exchange or not exchange the Initial Exchange Shares or the Remaining Exchange Shares, or any delays or disputes associated with the valuation process and subsequent price fluctuations of the public market price of the Company Stock.

 

(f)           The “ Current Market Price ” of a share of Company Stock shall be determined as provided in this Section 1.3(f). If the Company Stock is traded regularly in a public market, the fair market value of a share of Company Stock shall be the average of the closing prices of the Company Stock over a five (5) trading day period ending three (3) days before the applicable Exchange Closing. If the Company Stock is not regularly traded in a public market, the Board of Directors of the Company shall determine fair market value in its reasonable good faith judgment.

 

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1.4            Tag Along Rights . Pimentel shall have tag-along rights with respect to the Shares in the event that the Company proposes to sell, transfer or otherwise dispose of any of the Company’s shares of Synbiomics’ capital stock. If the Company proposes to engage, directly or indirectly, in a sale, transfer or other disposition (a “ Sale ”) of any shares of Synbiomics’ capital stock (the “ Offered Shares ”), and the Company receives a bona fide written offer (the “ Purchase Offer ”) from a person (the “ Offeror ”) to purchase the Offered Shares for a purchase price (the “ Offer Price ”) denominated and payable in United States dollars at closing or according to specified terms, with or without interest. Before making such a transfer, the Company shall, prior to consummating any Sale contemplated by this Section 1.4, immediately give to Pimentel written notice (such notice being referred to herein as the “ Notice of Transfer ”) setting froth the price and the terms of payment, and any other material terms of such proposed Sale. The Notice of Transfer shall constitute an offer by the Company to Pimentel to permit Pimentel to sell its shares of Synbiomics in the proposed Sale, for the same price and form of consideration to be received by the Company and otherwise upon the terms and subject to the conditions set forth in the Notice of Transfer, on a pro rata basis with the Company (based on respective shares of Synbiomics capital stock). For a period of twenty (20) days following receipt of the Notice of Transfer, Pimentel may, by delivering to the Company written notice of its election, elect irrevocably to participate as a seller in such proposed Sale on a pro rata basis with the Company. If Pimentel fails to respond within such 20-day period, Pimentel shall be deemed to have elected not to participate in the proposed Sale and shall have waived any and all rights under this Section with respect thereto. Within ten (10) days of the expiration of such 20-day period, the Company may consummate the transaction proposed in the applicable Purchase Offer and Notice of Transfer. Any such Synbiomics capital stock not so ttransferred during such 10-day period shall thereafter again be subject to the tag-along rights of Pimentel set forth in this Section 1.4.

 

1.5            Exchange Approval . Subject to the provisions of Section 6.2 below, the parties acknowledge that any issuance of stock by the Company of its common stock, including with respect to the license fees, patent expense reimbursements, milestones payments and share exchanges referred to above, is subject to the prior approval of the NYSE MKT or any other exchange upon which the shares of the Company are listed and if required by such exchange or any other rule or regulation applicable to Synbiomics or the Company, shareholder approval.

 

sECTION 2.         CLOSING AND DELIVERY

 

2.1            Issuance of Shares . Subject to the terms and conditions of this Agreement and in reliance upon the representations, warranties and agreements contained herein, on the date hereof, the Company will cause Synbiomics to issue to Pimentel, and Pimentel will acquire from Synbiomics, the Shares.

 

2.2            Closing . The closing of the purchase and sale of the Shares to be issued pursuant to Section 2.1 of this Agreement shall be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26 th Floor, New York, New York 10174 or at such other place as the Company and Pimentel may agree on simultaneously with the execution of this Agreement.

 

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2.3            Delivery of the Shares . Promptly following the date hereof, the Company shall cause to be delivered to Pimentel a certificate representing the number of Shares purchased hereunder, registered in the name of Pimentel.

 

sECTION 3.         REPRESENTATIONS AND WARRANTIES OF THE COMPANY AND SYNBIOMICS .

 

Subject to and except as set forth in the SEC Documents (as defined below), the Company and Synbiomic, jointly and severally, hereby represent and warrant to Pimentel 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 Nevada 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. Synbiomics is a corporation wholly owned by the Company and duly incorporated, validly existing and in good standing under the laws of the State of Nevada with the requisite corporate power to own, lease and operate its properties and assets and to conduct its business as it is now being conducted. Other than Synbiomics and those subsidiaries identified in its most recent report on Form 10-Q, the Company does not have any subsidiaries. Each of the Company and Synbiomics 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 or Synbiomics, as applicable, that is material and adverse to the Company or Synbiomics, as applicable, taken as a whole, and any condition, circumstance or situation that would prohibit the Company or Synbiomics, as applicable, from entering into and performing any of its obligations hereunder.

 

3.2            Authorization; Enforcement . Each of the Company and Synbiomics has the requisite corporate power and authority to enter into and perform this Agreement and Synbiomics has the requisite power and authority to issue and sell the Shares in accordance with the terms hereof. The execution, delivery and performance of this Agreement by the Company and Synbiomics and the consummation by each of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action, and no further consent or authorization of the Company, Synbiomics, either of its board of directors or stockholders is required for the issuance of the Shares, the issuance of the Company Stock or the consummation of the transactions contemplated hereby. When executed and delivered by the Company and Synbiomics, this Agreement shall constitute a valid and binding obligation of the Company and Synbiomics enforceable against each 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, creditor’s rights and remedies or by other equitable principles of general application.

 

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3.3            Issuance of Shares and Company Stock . The Shares and Company Stock 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, when issued such Shares and Company Stock, as applicable, 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, Synbiomics or the Company and rights of first refusal of any kind imposed by Synbiomics or the Company, as applicable (other than restrictions on transfer under applicable securities laws) and the holder of such Shares or Company Stock, as applicable, shall be entitled to all rights accorded to a holder of Common Stock of Synbiomics or the Company, as applicable. As of the date hereof, no shares of Synbiomics’ Common Stock are issued and outstanding. Synbiomics is authorized to issue fifty million (50,000,000) shares of Common Stock, of which forty-four million (44,000,000) shares of Common Stock will be outstanding after the issuance of the Shares. The Shares, when issued, will represent eleven and one half percent (8.5%) of the outstanding shares of common stock of Synbiomics of a Fully Diluted Basis. As of the date hereof, 44,654,414 shares of Company Stock are issued and outstanding.

 

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3.4            No Conflicts; Governmental Approvals . The execution, delivery and performance of the Agreement by the Company and Synbiomics and the consummation by the Company and Synbiomics of the transactions contemplated hereby do not and will not: (i) violate any provision of the Company’s or Synbiomics’ 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 or Synbiomics is a party or by which the Company’s or Synbiomics’ 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 Synbiomics or by which any property or asset of the Company or Synbiomics 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. Neither the Company nor Synbiomics is 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 the Shares in accordance with the terms hereof (other than any filings, consents and approvals required to be made by the Company or Synbiomics under applicable state and federal securities laws, securities and exchange commission rules or regulations, rules or regulations of any stock exchange upon which shares of common stock of the Company may be listed or rules or regulations prior to or subsequent to the date hereof).

 

3.5            SEC Documents, Financial Statements . The Company Stock is registered pursuant to Section 12(b) of the Exchange Act. During the two year period preceding the execution of 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 (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 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, other than with respect to its initial Annual Report on Form 10-K for the year ended December 31, 2011 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).

 

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3.6            Brokers . Neither the Company, Synbiomics nor any of the officers, directors or employees of the Company or Synbiomics has employed any broker or finder in connection with the transaction contemplated by this Agreement

 

sECTION 4.         REPRESENTATIONS, WARRANTIES AND COVENANTS OF Pimentel .

 

4.1            Purchaser Sophistication . Pimentel represents and warrants to, and covenants with, the Company and Synbiomics that Pimentel: (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 purchase of the Shares, including investments in securities issued by Synbiomics 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) Pimentel, in connection with its decision to purchase the Shares, relied only upon the documents of the Company filed with the Commission, other publicly available information, and the representations and warranties of the Company and Synbiomics contained herein. Pimentel is an “ accredited investor ” pursuant to Rule 501 of Regulation D under the Securities Act; (c) Pimentel 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) Pimentel has not been organized, reorganized or recapitalized specifically for the purpose of investing in the Shares; (e) Pimentel 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 of 1933 and applicable state securities laws; (f) Pimentel understands that the Shares are being offered and sold to it in reliance upon specific exemptions from the registration requirements of the Securities Act of 1933 and state securities laws, and that the Company and Synbiomics are relying upon the truth and accuracy of, and Pimentel’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of Pimentel set forth herein in order to determine the availability of such exemptions and the eligibility of Pimentel to acquire the Shares; (g) Pimentel understands that its investment in the Shares involves a significant degree of risk, including a risk of total loss of Pimentel’s investment; and (h) Pimentel 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 . Pimentel has the requisite power and authority to enter into and perform this Agreement and to purchase the Shares being sold to it hereunder. The execution, delivery and performance of this Agreement by Pimentel 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 Pimentel or its board of directors or stockholders is required. When executed and delivered by Pimentel, this Agreement shall constitute a valid and binding obligation of Pimentel enforceable against Pimentel 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, creditor’s rights and remedies or by other equitable principles of general application.

 

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4.3            No Conflict . The execution, delivery and performance of this Agreement by Pimentel and the consummation by Pimentel of the transactions contemplated hereby do not and will not: (i) violate any provision of Pimentel’s marital or other agreements; (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 Pimentel is a party or by which Pimentel’s 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 Pimentel or by which any property or asset of Pimentel 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 Pimentel’s ability to perform its obligations under the Agreement.

 

4.4            Restricted Shares . Pimentel acknowledges that the Shares are restricted securities and must be held indefinitely unless subsequently registered under the Securities Act of 1933 or Synbiomics receives an opinion of counsel reasonably satisfactory to Synbiomics that such registration is not required.

 

4.5            Stock Legends . Pimentel acknowledges that certificates evidencing the Shares shall bear a restrictive legend in substantially the following form (and including related stock transfer instructions and record notations):

 

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.

 

sECTION 5.         SURVIVAL OF REPRESENTATIONS, WARRANTIES AND AGREEMENTS .

 

Notwithstanding any investigation made by any party to this Agreement, all representations and warranties made by the Company, Synbiomics and Pimentel herein shall survive the execution of this Agreement and the issuance and sale to Pimentel of the Shares.

 

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sECTION 6.         COVENANTS.

 

6.1            Approval . In each case where the Company determines that the approval of the Company’s investors or any exchange or other listing upon which the Company Stock may be listed is required for the issuance of Company Stock to Pimentel, 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 Company Stock to be issued hereunder, then Pimentel shall have a one-time demand registration right, at its own expense, to request that Synbiomics register the Shares held by Pimentel with the Securities and Exchange Commission, subject to any Securities and Exchange Commission limitations; provided that such request is made within sixty (60) days of the date of notification from the Company to Pimentel of the position of the NYSE MKT.   If such registration is an underwritten  public offering then it shall be subject to standard underwriter cut backs and lock ups. If the managing underwriter of an underwritten public offering determines and advises Synbiomics in writing that the inclusion of all securities proposed to be included by Pimentel and Synbiomics and any other holders of Licensee securities requesting inclusion of their securities in the underwritten public offering would materially and adversely interfere with the successful marketing of the offering, then Pimentel shall not be permitted to include any Shares in excess of the amount, if any, of securities which the managing underwriter of such underwritten public offering shall reasonably and in good faith agree in writing to include in such public offering.

 

6.2            Upon request of Pimentel, the Company agrees to provide an opinion of counsel to its transfer agent regarding the removal of the legend on the Company Stock issued to Pimentel hereunder; provided that all legal requirements allowing for such legend removal and all applicable conditions under Rule 144 promulgated under the Securities Act of 1933 are met.

 

sECTION 7.         NOTICES.

 

7.1            Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to have been given (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient, (b) if sent by Federal Express or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient, or (c) if sent by facsimile transmission, when so sent and when receipt has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:

 

In the case of Pimentel to:

 

Mark Pimentel, M.D.

 

or in the case of the Company or Synbiomics to:

 

155 Gibbs Street, Suite 412

Rockville, MD 20850

Attention:

Fax No.: (734) 332-7878

 

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 7.1.

 

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sECTION 8.         MISCELLANEOUS .

 

8.1            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.

 

8.2            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.

 

8.3            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.

 

8.4            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.

 

8.5            Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of California as applied to contracts entered into and performed entirely in the State of California, without regard to conflicts of law principles.

 

8.6            Counterparts . This Agreement may be executed in two or more counterparts, 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.

 

8.7            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 Pimentel shall not assign its rights or obligations hereunder and Synbiomics shall only be able to assign its tights or obligations hereunder to an affiliated entity if the License Agreement is also assigned to such entity.

 

8.8            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.

 

8.9            Expenses . Each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement.

 

8.10          Entire Agreement . This Agreement (including the Schedule of Exceptions), License Agreement and other documents 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.

 

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8.11          Publicity . Except as otherwise provided herein, 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.

 

8.12          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.

 

8.13          Further Assurances . From and after the date of this Agreement, upon the reasonable request of Pimentel or the Company, the Company and Pimentel shall execute and deliver such instruments, documents and other writings as may be reasonably necessary or desirable to confirm and carry out and to effectuate fully the intent and purposes of this Agreement.

 

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IN WITNESS WHEREOF , the parties hereto have caused this Stock Purchase Agreement to be executed by their duly authorized representatives as of the day and year first above written.

 

  SYNTHETIC BIOMICS, INC.
     
  By:

/s/ Steve Kanzer

  Name: Steve Kanzer
  Title:

CEO & President

     
  SYNTHETIC BIOLOGICS, INC.
     
  By:

/s/ Jeff Riley

  Name:

Jeff Riley

  Title:

CEO

     
  MARK PIMENTEL, M.D.
     
  By: /s/ MARK PIMENTEL, M.D.
  Name: MARK PIMENTEL, M.D.
  Title:  

 

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STOCK PURCHASE AGREEMENT

 

THIS AGREEMENT (this “ Agreement ”) is made and entered into as of December 5, 2013 (the “ Effective Date ”), by and among Synthetic Biologics, Inc., a Nevada corporation (the “ Company ”), Synthetic Biomics, Inc., a Nevada corporation and wholly-owned subsidiary of the Company (“ Synbiomics ”), and Cedars-Sinai Medical Center, a California nonprofit public benefit corporation (“ CSMC ”).

 

A.            The Company and Synbiomics may (or may not) enter into license and option agreements with CSMC (the “ License Agreement ”), pursuant to which CSMC may license and option the rights to certain technology to Synbiomics; and

 

B.            In advance of such potential License Agreement (which may or may not be entered into), Synbiomics has agreed to issue to CSMC certain shares of Synbiomics’ common stock in exchange for $0.0001 per share (“ Common Stock ”), accordance with the terms and conditions of this Agreement.

 

AGREEMENT

 

In consideration of the mutual covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

 

sECTION 1.         AUTHORIZATION OF SALE OF SHARES ; ANTI-DILUTION; EXCHANGE OF SHARES.

 

1.1            Authorization . Subject to the terms and conditions of this Agreement, Synbiomics has duly authorized the issuance to CSMC of five million sixty thousand (5,060,000) shares of Common Stock (such shares, together with any Additional Shares issued in accordance with Section 1.2, the “ Shares ”) in exchange for Five Hundred and Six Dollars ($506.00) payable immediately by cash or check, which shares shall represent eleven and one-half percent (11.5%) of the shares of Synbiomics’ issued and outstanding capital stock on a Fully-Diluted Basis on the Effective Date. For purposes of this Agreement, the term “ Fully Diluted Basis ” shall include all of the issued and outstanding equity securities of Synbiomics (including, without limitation, all common stock, preferred stock and units of any kind) calculated on an “as-converted” basis plus all outstanding options, warrants and other securities exercisable or exchangeable for or convertible into equity securities of Synbiomics calculated on an “as-converted” basis plus any securities issued under any stock plan or other equity incentive plan or arrangement of Company then in effect or contemplated calculated on an “as-converted” basis.

 

 
 

 

1.2            Anti-Dilution Protection . Until such time as Synbiomics has received an aggregate of at least Three Million Dollars ($3,000,000) in cash proceeds from one or more investors in a bona fide equity financing transaction, including financing received from the Company (the “ Funding Threshold ”), CSMC and its affiliates shall continue to own not less than eleven and one-half percent (11.5%) of the shares of Synbiomics’ issued and outstanding capital stock on a Fully-Diluted Basis (or such lesser percentage if CSMC shall sell or transfer any of the Shares to any person or entity other than an affiliate, the “ Percentage Interest ”). To the extent any security, including any security convertible into or exercisable for shares of capital stock of Synbiomics, is issued to any entity or person that would cause CSMC’s equity ownership to fall below the Percentage Interest calculated on a Fully-Diluted Basis prior to the Synbiomics’ achievement of the Funding Threshold, then Synbiomics shall issue to CSMC, without further consideration from CSMC, additional shares of Common Stock in an amount sufficient to maintain the Percentage Interest calculated on a Fully Diluted Basis through the achievement of the Funding Threshold (the “ Additional Shares ”). Not later than five (5) business days after the consummation of any transaction triggering the issuance of Additional Shares, Synbiomics shall cause to be delivered to CSMC a certificate representing the number of Additional Shares issued hereunder, registered in the name of CSMC. Each of the representations and warranties of the Company and Synbiomics in this Agreement shall be true and correct as of the date of any issuance of the Additional Shares, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date.

 

1.3          Exchange of Shares .

 

(a)           As of the 18-month anniversary of the Effective Date, if the Shares are not then freely tradeable, CSMC shall have the right to exchange up to fifty percent (50%) of the Shares then held by CSMC (such shares, the “ Initial Exchange Shares ”) for shares of common stock, $0.001 par value, of the Company (“ Company Stock ”) pursuant to the terms set forth in this Section 1.3 by delivering a written notice to the Company (the “ First Exchange Notice ”) at least ninety (90) days prior to the 18-month anniversary of the Effective Date. The right of CSMC to exchange the Initial Exchange Shares is referred to as the “ First Exchange Right .” The number of shares of Company Stock for which the Initial Exchange Shares may be exchanged shall equal the quotient obtained by dividing (i) the aggregate Fair Market Value of the Initial Exchange Shares to be exchanged as determined in accordance with Section 1.3(e) below by (ii) the Current Market Price of a single share of Company Stock as determined in accordance with Section 1.3(f) below. The parties intend to exchange the Initial Exchange Shares for Company Stock pursuant to one (1) Exchange Closing transaction.

 

(b)           As of the 36-month anniversary of the Effective Date, if the Shares are not then freely tradeable, CSMC shall have the right to exchange up to the number of Shares then held by CSMC excluding any Initial Exchange Shares (whether or not exchanged pursuant to this Section 1.3) (the “ Remaining Exchange Shares ”) for shares of Company Stock pursuant to the terms of this Section 1.3 by delivering a written notice to the Company (the “ Second Exchange Notice ”) at least ninety (90) days prior to the 36-month anniversary of the Effective Date. The right of CSMC to exchange the Remaining Exchange Shares is referred to as the “ Second Exchange Right .” The number of shares of Company Stock for which the Remaining Exchange Shares may be exchanged shall equal the quotient obtained by dividing (i) the aggregate Fair Market Value of the Remaining Exchange Shares to be exchanged as determined in accordance with Section 1.3(e) below by (ii) the Current Market Price of a single share of Company Stock as determined in accordance with Section 1.3(f) below. The parties intend to exchange the Remaining Exchange Shares for Company Stock pursuant to one (1) Exchange Closing transaction.

 

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(c)           Unless the parties involved mutually agree otherwise, delivery to the Company of the share certificates representing the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, to be exchanged pursuant to this Section 1.3 shall take place at a closing (each, an “ Exchange Closing ”) to be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26th Floor, New York, New York 10174 or at such other place as the Company and CSMC may agree at 10:00 a.m. within two (2) calendar days following approval of the NYSE MKT with respect to such issuance. The Company shall promptly apply to the NYSE MKT for approval of the issuance of the shares of Company Stock after the determination of the applicable Fair Market Value for the Initial Exchange Shares or the Remaining Exchange Shares to be exchanged pursuant to this Section 1.3. Immediately prior to the transfer of title to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, to be exchanged at an Exchange Closing and issuance of Company Stock, CSMC shall provide the representations and warranties set forth in this Agreement as well as representations and warranties as to CSMC’s good and marketable title to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, and the absence of any liens, security interests or adverse claims of any kind arising by, through or under such CSMC, all as of a recent date, and CSMC shall deliver to the Company a certificate signed by an authorized officer on behalf of CSMC, dated as of the applicable Exchange Closing, regarding such representations and warranties. It shall be a condition to CSMC’s transfer of title to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, to be exchanged at an Exchange Closing that each of the representations and warranties of the Company and Synbiomics in this Agreement shall be true and correct as of the date of the applicable Exchange Closing, except for representations and warranties that speak as of a particular date, which shall be true and correct as of such date, and the Company shall deliver to CSMC a certificate signed by its Chief Executive Officer on behalf of the Company, dated as of the applicable Exchange Closing, certifying that such condition has been satisfied. CSMC agrees that as a condition to its receipt of any Company Stock pursuant to the terms of this Section 3 that it will enter into a customary “lockup” or “market standoff” agreement with a term no longer than four (4) months in a form reasonably satisfactory to the Company, and such agreement shall include customary exceptions including for transfers to affiliates.

 

(d)           No fractional shares or scrip representing fractional shares shall be issued upon the exchange of any Shares pursuant to this Section 1.3. As to any fraction of a share which CSMC would otherwise be entitled to purchase upon such exchange, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Current Market Price of a share of Company Stock or round up to the next whole share.

 

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(e)           The “ Fair Market Value ” of the Initial Exchange Shares and the Remaining Exchange Shares shall be determined based primarily upon the relative contribution of the valuation of Synbiomics to the public market capitalization of Company and as provided in this Section 1.3(e). Upon the Company’s receipt of the First Exchange Notice or the Second Exchange Notice, as applicable, CSMC and the Company shall forthwith attempt to agree upon the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable. If CSMC and the Company cannot agree on the Fair Market Value of the Initial Shares or the Remaining Exchange Shares, as applicable, within ten (10) days of the Company’s receipt of the First Exchange Notice or the Second Exchange Notice, as applicable, then CSMC and the Company shall, within ten (10) days of the end of such initial 10-day period (such period, the “ Mutual Selection Period ”), choose one mutually acceptable qualified independent appraiser to determine the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, and such appraiser shall deliver its written appraisal within twenty (20) days of the date of its selection and the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, shall be as set forth in such appraisal. If CSMC and the Company cannot agree on a mutually acceptable qualified independent appraiser within the Mutual Selection Period, then each of CSMC and the Company shall select a qualified independent appraiser to determine the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, within five (5) days after the end of the Mutual Selection Period. The appraisers so selected shall attempt to agree to the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable.  If they are unable to do so within twenty (20) days of the date of selection of the last of the appraisers selected, they shall furnish each party with their respective written appraisals within thirty (30) days of the date of selection of the last of the appraisers selected, which written appraisals shall set forth the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable.  If each valuation is within ten percent (10%) of the other valuation, the Fair Market Value shall be the numerical average (mean) of both valuations.  If each valuation is not within ten percent (10%) of the other valuation, then the two appraisers, within ten (10) days after submitting their respective valuations, shall mutually select and appoint a third appraiser, similarly qualified, and give written notice of that appointment to the Company and CSMC.  Within thirty (30) days after the appointment of the third appraiser, the third appraiser shall submit in writing its determination of the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable.  Thereafter, the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, shall be the numerical average (mean) of the two (2) valuations which are numerically closest together, unless one of the values is the numerical average (mean) of the three (3) values, in which case such value shall be the Fair Market Value. The Fair Market Value, as determined above, shall be conclusive, final and binding upon the Company and CSMC.  If either the Company or CSMC shall fail to appoint an appraiser within five (5) days after the end of the Mutual Selection Period referred to above, then, the appraiser appointed by the party which does appoint an appraiser shall alone determine the Fair Market Value of the Initial Exchange Shares or the Remaining Exchange Shares, as applicable, and such appraisal shall be binding. Any appraiser appointed in accordance with this Section 1.3(d) shall value Synbiomics as a going concern and shall not apply any illiquidity and minority discount to the Initial Exchange Shares or the Remaining Exchange Shares, as applicable. Each party shall compensate the appraiser appointed by such party, and the compensation of the first, mutually acceptable appraiser and the third appraiser, if any, and the expenses of the appraisal shall be borne equally by the Company and CSMC. Company shall have no lost opportunity liability to CSMC for CSMC’s decision to exchange or not exchange the Initial Exchange Shares or the Remaining Exchange Shares, or any delays or disputes associated with the valuation process and subsequent price fluctuations of the public market price of the Company Stock.

 

(f)           The “ Current Market Price ” of a share of Company Stock shall be determined as provided in this Section 1.3(f). If the Company Stock is traded regularly in a public market, the fair market value of a share of Company Stock shall be the average of the closing prices of the Company Stock over a five (5) trading day period ending three (3) days before the applicable Exchange Closing. If the Company Stock is not regularly traded in a public market, the Board of Directors of the Company shall determine fair market value in its reasonable good faith judgment.

 

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1.4            Tag-Along Rights . CSMC shall have tag-along rights with respect to the Shares in the event that the Company proposes to sell, transfer or otherwise dispose of any of the Company’s shares of Synbiomics’ capital stock. If the Company proposes to engage, directly or indirectly, in a sale, transfer or other disposition (a “ Sale ”) of any shares of Synbiomics’ capital stock (the “ Offered Shares ”), and the Company receives a bona fide written offer (the “ Purchase Offer ”) from a person (the “ Offeror ”) to purchase the Offered Shares for a purchase price (the “ Offer Price ”) denominated and payable in United States dollars at closing or according to specified terms, with or without interest, then before making such a transfer, the Company shall, prior to consummating any Sale contemplated by this Section 1.4, immediately give to CSMC written notice (such notice being referred to herein as the “ Notice of Transfer ”) setting froth the price and the terms of payment, and any other material terms of such proposed Sale. The Notice of Transfer shall constitute an offer by the Company to CSMC to permit CMSC to sell its shares of Synbiomics in the proposed Sale, for the same price and form of consideration to be received by the Company and otherwise upon the terms and subject to the conditions set forth in the Notice of Transfer, on a pro rata basis with the Company (based on respective shares of Synbiomics capital stock). For a period of twenty (20) days following receipt of the Notice of Transfer, CSMC may, by delivering to the Company written notice of its election, elect irrevocably to participate as a seller in such proposed Sale on a pro rata basis with the Company. If CSMC fails to respond within such 20-day period, CSMC shall be deemed to have elected not to participate in the proposed Sale and shall have waived any and all rights under this Section with respect thereto. Within ten (10) days of the expiration of such 20-day period, the Company may consummate the transaction proposed in the applicable Purchase Offer and Notice of Transfer. Any such Synbiomics capital stock not so transferred during such 10-day period shall thereafter again be subject to the tag-along rights of CSMC set forth in this Section 1.4.

 

1.5            Exchange Approval . Subject to the provisions of Section 6.2 below, the parties acknowledge that any issuance of stock by the Company of its common stock hereunder is subject to the prior approval of the NYSE MKT or any other exchange upon which the shares of the Company are listed and if required by such exchange or any other rule or regulation applicable to Synbiomics or the Company, shareholder approval.

 

sECTION 2.         CLOSING AND DELIVERY

 

2.1            Issuance of Shares . Subject to the terms and conditions of this Agreement and in reliance upon the representations, warranties and agreements contained herein, on the date hereof, the Company will cause Synbiomics to issue to CSMC, and CSMC will acquire from Synbiomics, the Shares.

 

2.2            Closing . The closing of the purchase and sale of the Shares to be issued pursuant to Section 2.1 of this Agreement shall be held at the offices of Gracin & Marlow, LLP, The Chrysler Building, 405 Lexington Avenue, 26 th Floor, New York, New York 10174 or at such other place as the Company and CSMC may agree on simultaneously with the execution of this Agreement.

 

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2.3            Delivery of the Shares . Promptly following the date hereof, the Company shall cause to be delivered to CSMC a certificate representing the number of Shares purchased hereunder, registered in the name of CSMC.

 

sECTION 3.         REPRESENTATIONS AND WARRANTIES OF THE COMPANY AND SYNBIOMICS .

 

Subject to and except as set forth in the SEC Documents (as defined below), the Company and Synbiomic, jointly and severally, hereby represent and warrant to CSMC 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 Nevada 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. Synbiomics is a corporation wholly owned by the Company and duly incorporated, validly existing and in good standing under the laws of the State of Nevada with the requisite corporate power to own, lease and operate its properties and assets and to conduct its business as it is now being conducted. Other than Synbiomics and those subsidiaries identified in its most recent report on Form 10-Q, the Company does not have any subsidiaries. Each of the Company and Synbiomics 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 or Synbiomics, as applicable, that is material and adverse to the Company or Synbiomics, as applicable, taken as a whole, and any condition, circumstance or situation that would prohibit the Company or Synbiomics, as applicable, from entering into and performing any of its obligations hereunder.

 

3.2            Authorization; Enforcement . Each of the Company and Synbiomics has the requisite corporate power and authority to enter into and perform this Agreement and Synbiomics has the requisite power and authority to issue and sell the Shares in accordance with the terms hereof. The execution, delivery and performance of this Agreement by the Company and Synbiomics and the consummation by each of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate action, and no further consent or authorization of the Company, Synbiomics, either of its board of directors or stockholders is required for the issuance of the Shares, the issuance of the Company Stock or the consummation of the transactions contemplated hereby. When executed and delivered by the Company and Synbiomics, this Agreement shall constitute a valid and binding obligation of the Company and Synbiomics enforceable against each 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, creditor’s rights and remedies or by other equitable principles of general application.

 

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3.3            Issuance of Shares and Company Stock . The Shares and Company Stock 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, when issued such Shares and Company Stock, as applicable, 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, Synbiomics or the Company and rights of first refusal of any kind imposed by Synbiomics or the Company, as applicable (other than restrictions on transfer under applicable securities laws) and the holder of such Shares or Company Stock, as applicable, shall be entitled to all rights accorded to a holder of Common Stock of Synbiomics or the Company, as applicable. As of the date hereof, no shares of Synbiomics’ Common Stock are issued and outstanding. Synbiomics is authorized to issue fifty million (50,000,000) shares of Common Stock, of which forty-four million (44,000,000) shares of Common Stock will be outstanding after the issuance of the Shares. The Shares, when issued, will represent eleven and one half percent (11.5%) of the outstanding shares of common stock of Synbiomics of a Fully Diluted Basis. As of the date hereof, 44,654,414 shares of Company Stock are issued and outstanding.

 

3.4            No Conflicts; Governmental Approvals . The execution, delivery and performance of the Agreement by the Company and Synbiomics and the consummation by the Company and Synbiomics of the transactions contemplated hereby do not and will not: (i) violate any provision of the Company’s or Synbiomics’ 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 or Synbiomics is a party or by which the Company’s or Synbiomics’ 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 Synbiomics or by which any property or asset of the Company or Synbiomics 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. Neither the Company nor Synbiomics is 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 the Shares in accordance with the terms hereof (other than any filings, consents and approvals required to be made by the Company or Synbiomics under applicable state and federal securities laws, securities and exchange commission rules or regulations, rules or regulations of any stock exchange upon which shares of common stock of the Company may be listed or rules or regulations prior to or subsequent to the date hereof).

 

7
 

 

3.5            SEC Documents, Financial Statements . The Company Stock is registered pursuant to Section 12(b) of the Exchange Act. During the two year period preceding the execution of 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 (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 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, other than with respect to its initial Annual Report on Form 10-K for the year ended December 31, 2011 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            Brokers . Neither the Company, Synbiomics nor any of the officers, directors or employees of the Company or Synbiomics has employed any broker or finder in connection with the transaction contemplated by this Agreement

 

sECTION 4.         REPRESENTATIONS, WARRANTIES AND COVENANTS OF CSMC .

 

4.1            Purchaser Sophistication . CSMC represents and warrants to, and covenants with, the Company and Synbiomics that CSMC: (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 purchase of the Shares, including investments in securities issued by Synbiomics 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) CSMC, in connection with its decision to purchase the Shares, relied only upon the documents of the Company filed with the Commission, other publicly available information, and the representations and warranties of the Company and Synbiomics contained herein. CSMC is an “ accredited investor ” pursuant to Rule 501 of Regulation D under the Securities Act; (c) CSMC 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) CSMC has not been organized, reorganized or recapitalized specifically for the purpose of investing in the Shares; (e) CSMC 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 of 1933 and applicable state securities laws; (f) CSMC understands that the Shares are being offered and sold to it in reliance upon specific exemptions from the registration requirements of the Securities Act of 1933 and state securities laws, and that the Company and Synbiomics are relying upon the truth and accuracy of, and CSMC’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of CSMC set forth herein in order to determine the availability of such exemptions and the eligibility of CSMC to acquire the Shares; (g) CSMC understands that its investment in the Shares involves a significant degree of risk, including a risk of total loss of CSMC’s investment; and (h) CSMC 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.

 

8
 

 

4.2            Authorization and Power . CSMC has the requisite power and authority to enter into and perform this Agreement and to purchase the Shares being sold to it hereunder. The execution, delivery and performance of this Agreement by CSMC 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 CSMC or its board of directors or stockholders is required. When executed and delivered by CSMC, this Agreement shall constitute a valid and binding obligation of CSMC enforceable against CSMC 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, creditor’s rights and remedies or by other equitable principles of general application.

 

4.3            No Conflict . The execution, delivery and performance of this Agreement by CSMC and the consummation by CSMC of the transactions contemplated hereby do not and will not: (i) violate any provision of CSMC’s 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 CSMC is a party or by which CSMC’s 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 CSMC or by which any property or asset of CSMC 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 CSMC’s ability to perform its obligations under the Agreement.

 

4.4            Restricted Shares . CSMC acknowledges that the Shares are restricted securities and must be held indefinitely unless subsequently registered under the Securities Act of 1933 or Synbiomics receives an opinion of counsel reasonably satisfactory to Synbiomics that such registration is not required.

 

4.5            Stock Legends . CSMC acknowledges that certificates evidencing the Shares shall bear a restrictive legend in substantially the following form (and including related stock transfer instructions and record notations):

 

9
 

 

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.

 

sECTION 5.         SURVIVAL OF REPRESENTATIONS, WARRANTIES AND AGREEMENTS .

 

Notwithstanding any investigation made by any party to this Agreement, all representations and warranties made by the Company, Synbiomics and CSMC herein shall survive the execution of this Agreement and the issuance and sale to CSMC of the Shares.

 

sECTION 6.         COVENANTS.

 

6.1            Approval . In each case where the Company determines that the approval of the Company’s shareholders or any exchange or other listing upon which the Company Stock may be listed is required for the issuance of Company Stock to CSMC, 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 Company Stock to be issued hereunder, then CSMC shall have a one-time demand registration right, at its own expense, to request that Synbiomics register the Shares held by CSMC with the Securities and Exchange Commission, subject to any Securities and Exchange Commission limitations; provided that such request is made within sixty (60) days of the date of notification from the Company to CSMC of the position of the NYSE MKT.   If such registration is an underwritten  public offering then it shall be subject to standard underwriter cut backs and lock ups. If the managing underwriter of an underwritten public offering determines and advises Synbiomics in writing that the inclusion of all securities proposed to be included by CSMC and Synbiomics and any other holders of Licensee securities requesting inclusion of their securities in the underwritten public offering would materially and adversely interfere with the successful marketing of the offering, then CSMC shall not be permitted to include any Shares in excess of the amount, if any, of securities which the managing underwriter of such underwritten public offering shall reasonably and in good faith agree in writing to include in such public offering.

 

6.2            Upon request of CSMC, the Company agrees to provide an opinion of counsel to its transfer agent regarding the removal of the legend on the Company Stock issued to CSMC hereunder; provided that all legal requirements allowing for such legend removal and all applicable conditions under Rule 144 promulgated under the Securities Act of 1933 are met.

 

10
 

 

sECTION 7.         NOTICES.

 

7.1            Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to have been given (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient, (b) if sent by Federal Express or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient, or (c) if sent by facsimile transmission, when so sent and when receipt has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:

 

In the case of CSMC to:

 

Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California 90048-1865

Attention: Senior Vice President for Academic Affairs

Fax No.:

 

with a copy to Senior Vice President for Legal Affairs & General Counsel

 

or in the case of the Company or Synbiomics to:

 

155 Gibbs Street, Suite 412

Rockville, MD 20850

Attention:

Fax No.: (734) 332-7878

 

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 7.1.

 

sECTION 8.         MISCELLANEOUS .

 

8.1            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.

 

8.2            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.

 

8.3            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.

 

8.4            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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8.5            Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of California as applied to contracts entered into and performed entirely in the State of California, without regard to conflicts of law principles.

 

8.6            Counterparts . This Agreement may be executed in two or more counterparts, 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.

 

8.7            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 CSMC shall not assign its rights or obligations hereunder and Synbiomics shall only be able to assign its tights or obligations hereunder to an affiliated entity if the License Agreement is also assigned to such entity.

 

8.8            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.

 

8.9            Expenses . Each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement.

 

8.10          Entire Agreement . This Agreement (including the Schedule of Exceptions), License Agreement and other documents 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.

 

8.11          Publicity . Except as otherwise provided herein, 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.

 

8.12          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.

 

8.13          Further Assurances . From and after the date of this Agreement, upon the reasonable request of CSMC or the Company, the Company and CSMC shall execute and deliver such instruments, documents and other writings as may be reasonably necessary or desirable to confirm and carry out and to effectuate fully the intent and purposes of this Agreement.

 

12
 

 

IN WITNESS WHEREOF , the parties hereto have caused this Stock Purchase Agreement to be executed by their duly authorized representatives as of the day and year first above written.

 

  SYNTHETIC BIOMICS, INC.
     
  By: /s/ Steve Kanzer
  Name: Steve Kanzer
  Title: CEO & President
   
  SYNTHETIC BIOLOGICS, INC.
   
  By: /s/ Jeff Riley
  Name: Jeff Riley
  Title: CEO
   
  CEDARS-SINAI MEDICAL CENTER
   
  By: /s/ Shlomo Melmed, M.D.
  Name: Shlomo Melmed, M.D.
  Title: Senior Vice President for Academic Affairs & Dean of the Medical Faculty
   
  By: /s/ Edward M. Prunchunas
  Name: Edward M. Prunchunas
  Title:    Senior Vice President for Finance & CFO

 

13

 

 

Synthetic Biologics and Intrexon Corporation Initiate Development of

Novel Biologics for a Subset of Patients Suffering from Irritable Bowel Syndrome (IBS)

 

— New Anti-Infective Program Underway Based on Innovative IBS Target —

 

For Immediate Release

 

Rockville, MD, and Germantown, MD, December 9, 2013 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious diseases and other diseases, and Intrexon Corporation (NYSE: XON) (“Intrexon”), a leader in synthetic biology, announced today that they have initiated development of novel biologic approaches for the prevention, as well as the acute and chronic treatment of a subset of irritable bowel syndrome (IBS) pathologies specifically caused by auto-antibodies.

 

Synthetic Biologics intends to utilize intellectual property optioned from Cedars-Sinai Medical Center (“Cedars-Sinai”). According to an increasing body of recent work conducted by Cedars-Sinai, a subset of IBS cases appear to be causally initiated by one or more encounters with acute infectious gastroenteritis, such as the foodborne illness , Campylobacter jejuni . Cedars-Sinai has identified a novel autoimmune target for this subset of IBS cases because of the development of cross-reacting antibodies between a bacterial toxin and a protein important for controlling gastrointestinal motility.

 

“We are thrilled to begin work with Intrexon for the development of novel biologic therapeutics targeted at preventing and treating auto-antibody-induced IBS. By accessing Intrexon’s proprietary technologies and capabilities, we will pursue development of a vaccine against the bacterial toxin, which does not yield cross reactivity with the gastrointestinal motility protein. Additionally, we will pursue novel approaches to treat acute exposure of the bacterial toxin, as well as block the activity of the auto-antibodies,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc.

 

Samuel Broder, M.D., Senior Vice President of Intrexon's Health sector and former Director of the National Cancer Institute stated, “Existing IBS therapies, which are primarily focused on supportive care, are unlikely to address the treatment needs of the patient population with auto-antibodies, an underlying immune-specific pathology. This new collaboration represents an important opportunity to address the unmet medical need in these patients with personalized medicine. The collaboration will target the root causes of a subset of irritable bowel syndrome-associated pathologies, and could have a significant impact on the prevention and therapy of this serious disorder.”

 

The initiation of biologic development for the prevention and treatment of both forms of IBS is the third pathogen-specific indication Synthetic Biologics intends to pursue as part of its August 2012 worldwide exclusive channel collaboration with Intrexon. Under this collaboration, the Company intends to utilize Intrexon’s comprehensive suite of proprietary technologies, including their extensive Protein Engineering assets, mAbLogix™, and LEAP™ platforms, to develop biologics to specifically and rapidly neutralize/clear pathogens that cause serious infectious diseases and other diseases. The first two target indications under the Intrexon collaboration continue to make well-paced progress. The development of a monoclonal antibody (mAb) therapy to treat life-threatening whooping cough (Pertussis) is expected to initiate an IND-enabling study during the first quarter of 2014. The generation of a panel of antibodies to target the multidrug-resistant pathogen, Acinetobacter , is ongoing. While Synthetic Biologics has initiated development of the initial three targets, the Intrexon collaboration may optionally be expanded to include up to a total of eight pathogen-specific indications.

 

 
 

 

About Synthetic Biologics, Inc.

 

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of product candidates for serious infectious diseases and other diseases. Synthetic Biologics is developing oral treatments targeting archaea, a non-bacterial intestinal form of life increasingly associated with chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes, an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of C. diff infection, a series of monoclonal antibodies (mAbs) for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of IBS. In addition, the Company is developing an oral estriol drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS (with results of an ongoing 164 subject, 15 center, two-year, double blind, placebo controlled, Phase II relapsing-remitting MS clinical trial expected to be announced during the first half of 2014). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.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 Company's 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 at www.dna.com .

 

Trademarks: mAbLogix™, LEAP™, UltraVector®, and Better DNA® are trademarks of Intrexon Corporation.

 

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the timeline for the Pertussis IND-enabling study, Synthetic Biologics’ use of Intrexon’s technologies and Cedar-Sinai intellectual property and the intended results of such use, the impact of the Intrexon collaboration on the prevention and therapy of certain irritable bowel syndrome associated pathologies. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure of Synthetic Biologics’ technologies for the treatment of infectious diseases and other diseases to be successfully developed or commercialized, a failure of the Intrexon’s intellectual property to develop the necessary biologics, an inability to obtain regulatory approval of the infectious disease and other disease product candidates, a failure of the results of clinical trials to support the efficacy or safety of product candidates, a failure of the preclinical or clinical trials to proceed on schedules that are consistent with Synthetic Biologics’ current expectations or at all, Synthetic Biologics’ inability to protect its intellectual property and freedom to operate without interference of the patents of others, inability to maintain the effectiveness of the exclusive collaboration agreement, its reliance on third parties to develop its product candidates, the insufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding Synthetic Biologics’ ability to obtain additional financing to support its operations thereafter and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2012 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

 

 
 

 

For further information, please contact:

 

Synthetic Biologics, Inc.

Kris Maly

Vice President, Corporate Communication

(734) 332-7800, Ext. 22

 

Intrexon Corporation

Peter McLaughlin

Vice President, Corporate Communications

Tel: +1 323-842-7779 PublicRelations@intrexon.com

 

###

 

 

 

 

Synthetic Biologics’ Webcast Conference Call Set for 9:00 a.m. EST

this Morning, December 9 th

 

— Webcast Call to Discuss Worldwide Agreements with Cedars-Sinai

for Development of New Treatments for IBS, Obesity and Diabetes —

 

For Immediate Release

 

Rockville, MD, December 9, 2013 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious diseases and other diseases, will host a webcast conference call and webcast this morning at 9:00 a.m. EST to discuss the announcement made Saturday, December 7, 2013 on the worldwide license and option agreements it entered into with Cedars-Sinai Medical Center (“Cedars-Sinai”) for the development of new drugs to target non-bacterial intestinal microorganism life forms known as archaea that are associated with chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes.

 

The full text of Saturday’s announcement appears below.

 

Jeffrey Riley, Synthetic Biologics’ Chief Executive Officer, will host the call. During the call, Mark Pimentel, M.D., FRCP(C), Director of the Gastrointestinal Motility Program at Cedars-Sinai, will provide an audio-visual presentation overview of the scientific basis and market opportunity of our new pathogen-specific approaches to archaea-associated diseases, such as, C-IBS, obesity and diabetes.

 

Interested parties should call 1-877-870-4263, (U.S. toll free), 1-855-669-9657 (Canada toll free), or +1-412-317-0790 (International), fifteen minutes before the start of the call to register. Registered callers on the toll free line may ask to be placed in the queue for the Question & Answer Session. The call will also be webcast over the Internet with a slide presentation at http://www.videonewswire.com/event.asp?id=97322 . If you are unable to participate during the live conference call, the webcast will be available for replay at the same URL, http://www.videonewswire.com/event.asp?id=97322 for 30 days after the call.

 

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Synthetic Biologics Enters into License with Cedars-Sinai Medical Center to Develop Novel

Anti-infective Approaches for Irritable Bowel Syndrome (IBS), Obesity and Diabetes

 

— Webcast to be held Monday, December 9 th at 9:00 a.m. EST —

 

For Immediate Release

 

Rockville, MD, December 7, 2013 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious diseases and other diseases, announced today that it entered into worldwide license and option agreements with Cedars-Sinai Medical Center (“Cedars-Sinai”) for the development of new treatment approaches to target non-bacterial intestinal microorganism life forms known as archaea that are associated with intestinal methane production and chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes, through its newly formed subsidiary, Synthetic Biomics, Inc.

 

 
 

 

Cedars-Sinai investigators have discovered that eradicating archaea and inhibiting intestinal methane production may treat the underlying cause of major diseases not typically considered forms of infectious diseases. IBS, one of the most prevalent chronic diseases, affects approximately 40 million Americans (an estimated 16 million of which have the archaea-associated constipation-predominant form of the disease (C-IBS)). Obesity affects over one-third (35.7%) of adult Americans according to the Centers for Disease Control (CDC). Diabetes affects an estimated 25.8 million Americans according to the CDC.

 

Ongoing efforts include formulating and clinically testing non-antibiotic FDA-approved oral drug candidates for ultimate product registration via potential expedited pathways. Such candidates are intended for the specific eradication of gastrointestinal archaea and prevention of their recolonization, with the goal of having little or no impact on a patient’s normal bacterial microflora. These efforts are being led by Mark Pimentel, M.D., FRCP(C), Director of the Gastrointestinal Motility Program at Cedars-Sinai Medical Center, who is credited with discovering that IBS is a form of infectious disease, in which gut microflora that should normally be confined to the large intestine inappropriately colonize the small intestine. This process is referred to as small intestinal bacterial overgrowth (SIBO), which results in gas, bloating, abdominal pain and altered stool habits characterized by IBS. The Company licensed and optioned from Cedars-Sinai a portfolio of intellectual property comprised of several U.S. and international patents and pending patent applications for various fields of use, including C-IBS, obesity and diabetes.

 

"We are pleased to initiate this exciting new anti-infective approach to treat these major archaea-implicated disease indications with Cedars-Sinai along with Dr. Pimentel’s leadership,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics, Inc. "This program complements our current microbiome focus and expertise, which includes development of an oral biologic to protect the microbiome from the effects of hospital administered IV antibiotics for the prevention of C. diff infection.”

 

Dr. Pimentel stated, “Since uncovering the fundamental role that small intestinal bacterial overgrowth plays in IBS, our group has continued to uncover and increasingly appreciate the role that intestinal archaea play in highly prevalent disease areas including, C-IBS, obesity, and type 2 diabetes. I am excited to be working with Synthetic Biologics and its newly formed subsidiary, Synthetic Biomics, to develop potential breakthrough pathogen-specific approaches for these major disease indications.”

 

Synthetic Biologics’ Conference Call

 

Synthetic Biologics’ Chief Executive Officer, Jeffrey Riley, will host a conference call on Monday, December 9 th at 9:00 a.m. EST. During the call, Mark Pimentel, M.D., FRCP(C), Director of the Gastrointestinal Motility Program at Cedars-Sinai, will provide an audio-visual presentation overview of the scientific basis and market opportunity of our new pathogen-specific approaches to archaea-associated diseases, such as, C-IBS, obesity and diabetes.

 

Interested parties should call 1-877-870-4263, (U.S. toll free), 1-855-669-9657 (Canada toll free), or +1-412-317-0790 (International), fifteen minutes before the start of the call to register. Registered callers on the toll free line may ask to be placed in the queue for the Question & Answer Session. The call will also be webcast over the Internet with a slide presentation at http://www.videonewswire.com/event.asp?id=97322 . If you are unable to participate during the live conference call, the webcast will be available for replay at the same URL, http://www.videonewswire.com/event.asp?id=97322 for 30 days after the call.

 

 
 

 

About Cedars-Sinai Medical Center

 

Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as advances in biomedical research and innovative medical education programs. For more than 20 years, Los Angeles-area residents have named Cedars-Sinai the "Most Preferred Hospital for All Health Needs" in National Research Corporation's annual Healthcare Market Guide survey. Cedars-Sinai Medical Group and Cedars-Sinai Health Associates both ranked among the top 10 physician groups in Southern California by Integrated Health Care Associates (IHA), a California leadership group of health plans, physician groups, and health systems. Today, Cedars-Sinai is committed to providing superior outpatient, acute and sub-acute patient care, breakthrough biomedical research, graduate and undergraduate medical education and community service.

 

About Synthetic Biologics, Inc.

 

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of product candidates for serious infectious diseases and other diseases. Synthetic Biologics is developing oral treatments targeting archaea, a non-bacterial intestinal form of life increasingly associated with chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes, an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of C. diff infection, and a series of monoclonal antibodies (mAbs) for the treatment of Pertussis and Acinetobacter infections. In addition, the Company is developing an oral estriol drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS (with results of an ongoing 164 subject, 15 center, two-year, double blind, placebo controlled, Phase II relapsing-remitting MS clinical trial expected to be announced during the first half of 2014). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com .

 

This release includes forward-looking statements on Synthetic Biologics' current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the potential for the new anti-infective program and the role of the microbiome in C. difficile and C-IBS . The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics' forward-looking statements include, among others, our inability to obtain financing on acceptable terms to permit us to timely commence or complete the clinical trials and discovery programs consistent with our current expectations, our inability to successfully develop, receive regulatory approvals for or to commercialize new product candidates or achieve desired results from the new anti-infective program and other factors described in Synthetic Biologics' report on Form 10-K for the year ended December 31, 2012 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

 

For further information, please contact:

 

Kris Maly

Vice President, Corporate Communication

(734) 332-7800, ext. 22

 

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