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): September 3, 2014

 

Commission File No. 000-16929

 

Soligenix, Inc.

(Exact name of small business issuer as specified in its charter)

 

DELAWARE   41-1505029
(State or other jurisdiction of incorporation or
organization)
  (I.R.S. Employer
Identification Number)

  

29 Emmons Drive,

Suite C-10

Princeton, NJ

 

 

 

08540

(Address of principal executive offices)   (Zip Code)

 

(609) 538-8200
(Issuer’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 
 

 

Item 1.01 Entry Into a Material Definitive Agreement.

 

On September 3, 2014, Soligenix, Inc. (the “Company”) entered into an asset purchase agreement (the “Purchase Agreement”) with Hy Biopharma, Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain tangible and intangible assets, properties and rights (the “Hypercin Assets”) of Hy Biopharma related to the development of Hy Biopharma’s synthetic hypericin product. Provided all success-oriented milestones are attained, the purchase price for the Hypercin Assets is $14.025 million, of which approximately 2% is payable in cash and approximately 98% is payable in restricted securities of the Company, and the assumption of certain liabilities of Hy Biopharma related to the Hypercin Assets.

 

Also on September 3, 2014, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with Hy Biopharma, pursuant to which the Company agreed to file with the U.S. Securities and Exchange Commission a registration statement to register for resale under the Securities Act of 1933, as amended, the shares that have been or may be issued to Hy Biopharma in connection with the Purchase Agreement.

 

The foregoing description of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of the Purchase Agreement and the Registration Rights Agreement, a copy of each of which is attached hereto as Exhibits 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference.

 

The Purchase Agreement and the Registration Rights Agreement are provided to give investors information regarding the agreements’ respective terms. They are not provided to give investors factual information about the Company or the other party thereto. In addition, the representations, warranties and covenants contained in the Purchase Agreement and the Registration Rights Agreement were made only for purposes of those agreements and as of specific dates, were solely for the benefit of the parties to those agreements, and may be subject to limitations agreed by the contracting parties, including being qualified by disclosures exchanged between the parties in connection with the execution of such agreements. The representations and warranties may have been 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 are not third-party beneficiaries under these agreements and should not view the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or conditions of the Company.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)      Exhibits

 

Exhibit No.   Description
              
10.1* Asset Purchase Agreement dated September 3, 2014 between the Company and Hy Biopharma, Inc.  
     
10.2   Registration Rights Agreement dated September 3, 2014 between the Company and Hy Biopharma, Inc.
     
99.1   Press Release issued by the Company on September 5, 2014.

 

 

* Portions of this exhibit have been omitted pursuant to a request for confidential treatment.

 

2
 

 

SIGNATURE

 

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.

 

  Soligenix, Inc.  
   
  By: /s/ Christopher J. Schaber 
September 5, 2014   Christopher J. Schaber, Ph.D.
    President and Chief Executive Officer
    (Principal Executive Officer)

  

3
 

 

EXHIBIT INDEX

 

Exhibit No.   Description
              
10.1* Asset Purchase Agreement dated September 3, 2014 between the Company and Hy Biopharma, Inc.  
     
10.2   Registration Rights Agreement dated September 3, 2014 between the Company and Hy Biopharma, Inc.
     
99.1   Press Release issued by the Company on September 5, 2014.

 

 

4


EXHIBIT 10.1

 

REDACTED VERSION

 

CONFIDENTIAL

 

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.

 

ASSET PURCHASE AGREEMENT

dated as of September 3, 2014,

between

SOLIGENIX, INC.

as Buyer

and

HY BIOPHARMA, INC.

as Seller

 
 


 

CONFIDENTIAL

 

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. 

 

TABLE OF CONTENTS

      Page
       
1. Purchase and Sale of the Purchased Assets 1
       
  1.1. Assets Being Sold to Buyer 1
  1.2. Excluded Assets 3
  1.3. Assumption of Certain Liabilities 4
  1.4. Excluded Liabilities 4
  1.5. Purchase Price 5
  1.6. Further Assurances 7
  1.7 . Consent of Third Parties 7
       
2 . Closing; Deliveries at Closing 8
       
  2.1. Preparation for Closing 8
  2.2. Closing 8
  2.3. Deliveries at Closing 8
       
3. Representations of Seller 8
       
  3.1. Due Incorporation and Good Standing 8
  3.2. Authorization; Enforcement; Validity 8
  3.3. No Violation or Approval 9
  3.4. Title to Purchased Assets 9
  3.5. Intellectual Property 9
  3.6. Regulatory Issues 10
  3.7. Absence of Certain Changes or Events 11
  3.8. Certain Contracts and Arrangements 11
  3.9. Litigation 12
  3.10. Compliance with Law, Permits and Licenses 12
  3.11. Brokers, Finders, Etc. 12
  3.12. Investment Intent 13
  3.13. Accredited Investor Status 13
  3.14. General Solicitation 13
  3.15. Access to Information 13
  3.16. Tax 13
  3.17. Insurance 14
  3.18. Seller Employees 14
  3.19. Environmental 15
  3.20. Related Party Transactions 15
  3.21. Absence of Questionable Payments; Business Relationships 15
  3.22. Disclosure 15
  3.23. Solvency 15
  3.24. Disclaimer 16

 

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CONFIDENTIAL

 

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. Representations of Buyer 16
       
  4.1. Due Incorporation and Good Standing 16
  4.2. Authorization; Enforcement; Validity 17
  4.3. No Violation or Approval 17
  4.4. Issuance of Securities 17
  4.5. Certain Registration Matters 17
  4.6. Brokers, Finders, etc. 17
  4.7. Buyer SEC Documents; Financial Statements 18
  4.8. Disclosure 18
       
5. Compliance With Securities Laws 19
       
  5.1. Restriction on Transfer 19
  5.2. Restrictive Legend 19
       
6. Conditions Precedent to the Obligations of Buyer 19
       
  6.1. Representations and Warranties 19
  6.2. Bill of Sale, Assignment and Assumption Agreement 20
  6.3. Registration Rights Agreement 20
  6.4. Patents 20
  6.5. No Injunction 20
  6.6. Performance 20
  6.7. Letters to Regulatory Authorities 20
  6.8. Letters to Third Party Vendors 20
  6.9. Releases of Encumbrances 20
  6.10. General 20
       
7. Conditions Precedent to Obligations of Seller 21
       
  7.1. Representations and Warranties 21
  7.2. Payment Acknowledgment, Assignment and Assumption Agreements 21
  7.3. Registration Rights Agreement 21
  7.4. No Injunction 21
  7.5. Performance 21
  7.6. Letters to Regulatory Authorities 21

 

- ii -
 

 

CONFIDENTIAL

 

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. Covenants of the Parties 21  
       
  8.1. Access to Premises, Information, and Contracting Parties 21
  8.2. Preservation of Purchased Assets Prior to Transfer of Purchased Assets 22
  8.3. Confidential Information 22
  8.4. No Public Announcement 22
  8.5. Satisfaction of Excluded Liabilities and Assumed Liabilities 23
  8.6. Survival of Representations and Warranties 22
  8.7. Tax Reporting 23
  8.8. Liquidation 23
       
9. Limitations on Liability 23
       
  9.1. Definitions 23
  9.2. Limitation 24
       
10. Miscellaneous 24
       
  10.1. Notices 24
  10.2. Risk of Loss 25
  10.3. Entire Agreement 25
  10.4. Assignment 25
  10.5. Governing Law 25
  10.6. No Third Party Beneficiaries 25
  10.7. No Liability of Officers and Directors 25
  10.8. Counterparts 25
  10.9. Headings 25

 

List of Schedules
   
Schedule 1.1.2 Patents
Schedule 1.1.7 Preclinical Testing, Studies and Clinical Trials
Schedule 1.1.12 Assigned Contracts
Schedule 1.1.13 Inventory
Schedule 1.1.14 Vendors
Schedule 3 Exceptions to Representations and Warranties
Schedule 3.8.1 Contracts Relating to Purchased Assets
Schedule 3.17 Insurance
   
List of Exhibits
   
Exhibit 6.2(a) Bill of Sale
Exhibit 6.2(b) Assumption and Assignment Agreement
Exhibit 6.3 Registration Rights Agreement
Exhibit 6.4 Assignment of Patents
Exhibit 6.7 Sample Letter to Regulatory Authorities

 

- iii -
 

CONFIDENTIAL

 

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.

 

ASSET PURCHASE AGREEMENT

 

THIS ASSET PURCHASE AGREEMENT (this “ Agreement ”) is made as of September 3, 2014, between Soligenix, Inc. , a Delaware corporation (“ Soligenix ”) (the “ Buyer ”), and Hy BioPharma, Inc. , a Delaware corporation (the “ Seller ”).

RECITALS

A.            The Seller is the owner or licensee of intellectual property and rights to develop and commercialize a certain synthetic hypericin product candidate (the “ Product ”);

B.            The Buyer desires to purchase from the Seller certain assets of the Seller related to the Product and the Purchased Assets (set forth in Section 1.1 hereof) free and clear of liens, claims, and encumbrances and to assume only certain specified liabilities of Seller related thereto, all on the terms and subject to the conditions set forth in this Agreement;

C.            The Buyer and the Seller have entered into that certain Exclusive Option to Purchase Assets dated as of April 1, 2014 (the “ Option Agreement ”).

D.            The parties desire that the consummation of the transactions contemplated by this Agreement qualify as to the Seller and its shareholders as a tax free reorganization under Section 368(a)(1)(C) of the Internal Revenue Code of 1986, as amended.

NOW, THEREFORE, in consideration of these premises, the respective covenants of the Buyer and the Seller set forth below and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1.               Purchase and Sale of the Purchased Assets .

1.1.           Assets Being Sold to Buyer. Subject to the terms and conditions of this Agreement, the Seller shall sell and assign to the Buyer, and the Buyer shall purchase from Seller at the Closing (as hereinafter defined), all of Seller’s rights, title and interests in, to and under the following assets (collectively, the “ Purchased Assets ”) as the same exist on the date hereof and on the Closing Date (as hereafter defined):

1.1.1.          The Product;

 

1.1.2.          All United States and foreign patents, patent applications, and all continuations, continuations in part, divisionals, renewals, reissues, or reexaminations thereof listed on Schedule 1.1.2 or any related applications thereto related to the Product (the “ Patents ”);

 

1.1.3.          All registered and unregistered copyrights, computer programs, and computer software related to the Product;

 

- 1 -
 

 

CONFIDENTIAL

 

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. 

 

1.1.4.         All know-how, trade secrets, formulae, processes, manufacturing know how, related to the Product;

 

1.1.5.          All filings, registrations, reports, correspondence and other documents related to the Product, including, without limitation, all filings with any governmental authorities or quasi-governmental agencies (including the United States Food and Drug Administration (“ FDA ”), the National Institutes of Health, Biomedical Advanced Research and Development Authority or any other similar governmental or quasi-governmental agency (collectively, with the FDA, “ Regulatory Authorities ”)) for the purpose of obtaining consent to conduct clinical trials for a product or approval or funding from such Regulatory Authorities to commence development, making, using, or selling the Product, including without limitation any investigational new drug applications, new drug applications, orphan drug designations and exclusive rights to reference all filings, registrations, and correspondence with any such Regulatory Authorities, including those listed on Schedule; 

 

1.1.6.          All correspondence and communications with the FDA or any other Regulatory Authorities in the Seller’s possession or control related to the Product;

 

1.1.7.          All preclinical testing, studies and clinical trials of the Product, including, but not limited to the studies listed on Schedule 1.1.7 , and all files, documents, data, study reports, audit reports, and other information in the Seller’s possession or control related thereto;

 

1.1.8.          Copies of all correspondence, files, file history, including all filings, in the Seller’s possession or control between the Seller or its patent counsel and patent offices, including the U.S. Patent and Trademark Office, related to the Patents;

 

1.1.9.          All data, reports, protocols, standard operating procedures, methods, models, screens, assays, pre-clinical and clinical trial data, data created with a view to producing registrations, chemical, pharmacological, toxicological, clinical, analytical, quality control, and safety data in the Seller’s possession or control related to the Product;

 

1.1.10.         All (a) compounds, compositions of matter, assays, and materials related to the Product; and (b) other documents, files, diagrams, specifications, designs, schematics, reports, records, laboratory notebooks, raw data, manufacturing and other materials, packaging, commercial or other market information, chain of ownership, prototypes, test devices, models, or simulations in the Seller’s possession or control related to the Product;

 

1.1.11.        All correspondence in the Seller’s possession or control related to the Product with any party involved in the chain of ownership of the Product and all other records related to the Product;

 

1.1.12.        Subject to the receipt of applicable consents from third parties, all rights of the Seller under any license, contract, or agreement related to the Product listed on Schedule 1.1.12 hereto and under other contracts related to the Product that the Buyer shall elect to assume by notice to Seller in writing (collectively, the “ Assigned Contracts ”);

 

- 2 -
 

 

CONFIDENTIAL

 

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.  

 

1.1.13.        Any and all (a) good and usable inventory of the Seller (whether raw materials, work-in-process, or finished goods) related to the Products, which is listed in Schedule 1.1.13 , and (b) material deemed as unusable and related to the Products and which are maintained for historical or other purposes, which is listed Schedule 1.1.13 ; together with related packaging materials, product samples, and all rights to acquire such inventory in the possession or control of third parties; and

 

1.1.14.        The names and contact information for any and all third party vendors, consultants, or contract manufacturers that have provided or are providing services, directly or indirectly, to the Seller with respect to the Purchased Assets, as listed on Schedule 1.1.14 .

 

1.2.           Excluded Assets. The Purchased Assets shall not include any other assets of the Seller, including, but not limited to, the following (collectively, the “ Excluded Assets ”):

1.2.1.          Any cash, cash equivalents, and securities on hand as of the Closing, wherever located, including, without limitation, in accounts, lock boxes, and other similar accounts (whether maintained at a bank, savings and loan, or other financial institution);

 

1.2.2.          Any income tax refunds or other tax refunds;

 

1.2.3.          Any claims or causes of action;

 

1.2.4.          Any contracts not explicitly assumed by the Buyer pursuant to Section 1.1.12 ;

 

1.2.5.          Any accounts receivable (including accounts receivable related to the Product), intercompany claims, general intangibles, prepaid expenses, deposits, and other current assets of the Seller;

 

1.2.6.          Any insurance policies and related claims and all proceeds of insurance policies or related claims;

 

1.2.7.           Any fixtures, furniture, and equipment, including office equipment, telephone systems and computers, leasehold improvements, office supplies, and personal property not related to the Product, and other physical assets of Seller not related to the Product;

 

1.2.8.          Any claims of liability with respect to any clinical trials conducted with the Product prior to the date hereof, including without limitation any product liability claims and/or any claims for death, injury or damages to properties; and

 

- 3 -
 

   

CONFIDENTIAL

 

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.  

 

1.2.9         Any records and communications relating to the negotiation and consummation of the transactions contemplated by this Agreement, including (i) communications with third parties and analyses relating to such transactions and (ii) communications with legal counsel representing Seller and the right to assert the attorney-client privilege with respect thereto.

 

1.3.           Assumption of Certain Liabilities. At the Closing, the Buyer shall assume only the following liabilities of Seller relating to the Purchased Assets (“ Assumed Liabilities ”):

1.3.1.          all payment or performance obligations and related liabilities that arise after the Closing under the Assigned Contracts; and

 

1.3.2.        all ongoing obligations to Regulatory Authorities with respect to the Product after the Closing Date. 

 

1.4.           Excluded Liabilities . Except as specifically described in Section 1.3 , the Buyer shall not assume any claim, liability or obligation of the Seller whatsoever, actual or contingent, known or unknown, direct or indirect (including without limitation under any third party beneficiary claim) whether or not any such liability or obligation pertains to the Purchased Assets (“ Excluded Liabilities ”), including without limitation:

1.4.1.           liability for making payments of any kind to employees or contractors of the Seller or its affiliates (including, as a result of the transactions contemplated hereby, as a result of the termination of employment or contract by the Seller or its affiliates of employees or contractors);

 

1.4.2.           any liabilities resulting from or arising out of any violation of any environmental requirements by the Seller or its affiliates relating to the use, disposal or generation of hazardous materials by the Seller or its affiliates or the existence of any hazardous materials in the Purchased Assets or the properties or migration of such hazardous materials therefrom;

 

1.4.3.          liability for any violation or breach of any federal, state, or local laws, regulations, orders or decision;

 

1.4.4.          liability for other accrued or deferred and unpaid taxes, including, but not limited to, income, sales, real estate and personal property taxes and any interest and penalties with respect thereto;

 

1.4.5.            liability for payroll taxes for employees of the Seller or its affiliates;

 

1.4.6.            liability for making payments of any kind as a result of the termination of any agency relationship with any of the Seller or its affiliates;

 

- 4 -
 

 

CONFIDENTIAL

 

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.  

 

1.4.7.            liability for pensions or other benefits to employees of the Seller or its affiliates;

 

1.4.8.           all liability arising from any inventories purchased hereunder, including, without limitation, for products or labeling or branding materials included as part of, or produced from such inventories;

 

1.4.9.           liability for payment of accounts payable or other liabilities incurred by the Seller;

 

1.4.10.        liability or obligation, whether for the payment of royalties, milestone payments, fees, indemnities or other liabilities or obligations, under any contract or agreement of the Seller;

 

1.4.11.         any claim, liability or obligation to the Seller’s shareholders; or

 

1.4.12.         any claim, liability or obligation with respect to any clinical trials conducted with the Product prior to the date hereof, including without limitation any product liability claims and/or any claims for death, injury or damages to properties.

 

In addition to the foregoing, except as set forth in Section 1.5, in no event shall the Buyer assume or incur any liability or obligation in respect of any federal, state or local income or other tax liability of the Seller payable with respect to the Purchased Assets, or the properties or operations of the Seller for any period through the Closing Date or incident to or arising as a consequence of the negotiation or consummation by the Seller of this Agreement and the transactions contemplated by this Agreement.

1.5.            Purchase Price. The purchase price to be paid by the Buyer to the Seller for the Purchased Assets (collectively, the “ Purchase Price ”) shall be in the amounts and paid as follows:

1.5.1.          a one-time payment of $[*****] ($[*****] of which shall be paid in shares of common stock, par value $0.001 per share (“ Common Stock ”), of the Company calculated using the “Ten Day Average Price” (as defined in this Section 1.5 ) immediately prior to the Closing Date, as reported by OTC Markets Group Inc., and $[*****] of which shall be paid in cash, by wire transfer of immediately available funds to an account specified by the Seller); (collectively, the “ Initial Payment ”);

 

1.5.2.          if the Phase III clinical trial of the Product is successful in demonstrating efficacy and safety in the Cutaneous T cell Lymphomas (“ CTCL ”) patient population, which includes but is not limited to achieving statistical significance in its primary endpoint consistent with the FDA agreed to protocol and statistical analysis plan, a one-time payment of $[*****], paid in shares of Common Stock, calculated using the Ten Day Average Price immediately prior to the earlier of (a) the date that the Phase III clinical trial of the Product is determined to be successful in the treatment of CTCL, as reported by OTC Markets Group Inc. and (b) the earliest public announcement by the Buyer of such determination or the likelihood of receiving such determination; and

 

- 5 -
 

 

CONFIDENTIAL

 

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.

 

1.5.3.          if the Product is approved for the treatment of CTCL by either the FDA or the European Medicines Agency (“EMA”), a one-time payment of $[*****], paid in shares of Common Stock, calculated using the Ten Day Average Price immediately prior to the earlier of (a) receipt of official notification of FDA or EMA approval or (b) the earliest public announcement by the Buyer of such approval or the likelihood of receiving such approval.

 

1.5.4.          Seller shall have the right to assign its right to receive shares of Common Stock under this Section 1.5 to no more than 35 of its stockholders, officers, directors, or creditors.

 

In the event that the issuance of shares of Common Stock required by Sections 1.5.1, 1.5.2 and 1.5.3 would result in the aggregate issuance of more than 20% of the outstanding shares of Common Stock under this Section 1.5, after giving effect to all such issuances, the number of shares issuable pursuant to Sections 1.5.1, 1.5.2 and 1.5.3 shall be reduced so that the aggregate number of shares issued pursuant to this Section 1.5 shall be one share less than 20% of the outstanding shares of Common Stock, after giving effect to all shares of Common Stock issued under Sections 1.5.1, 1.5.2 and 1.5.3.

The Buyer shall use commercially reasonable diligence including, but not limited to, the expenditure of reasonable funds, to pursue the commercialization of drugs (including for treatment of CTCL) using the Purchased Assets. For the purposes of this Agreement, “commercially reasonable diligence” shall mean those efforts expended by the Buyer on its own priority projects.

Additionally, the Buyer will be responsible for all shipping and handling costs, fees, taxes or duties associated with the delivery of the Purchased Assets, up to a maximum of Ten Thousand Dollars ($10,000). For the purpose of this Agreement, the “ Ten Day Average Price ” shall mean the average closing price of the Common Stock for the ten days on which the market or exchange on which the Common Stock is listed or quoted for trading is open for trading immediately preceding a particular date.

 

The Seller hereby covenants and agrees that the Seller will not, by any voluntary action, avoid or seek to avoid the observance or performance of its obligations under this Section 1.5, and will at all times in good faith carry out all the provisions of this Section 1.5. Without limiting the general nature of the foregoing, in the event of a Fundamental Transaction (as defined below), the Buyer shall provide in such Fundamental Transaction that, in lieu of issuing the shares of Common Stock that may become issuable pursuant to this Section 1.5, the Seller’s right to shares of Common Stock be satisfied by any successor to the Buyer or affiliate of such successor in the Fundamental Transaction either (a) as a payment in cash equal to the value of such shares of Common Stock (without interest or earnings), based on the amount payable to the Buyer’s stockholders in connection with the Fundamental Transaction under any agreement pursuant to which the transactions constituting the Fundamental Transaction are effected, and/or (b) in shares of the capital stock of any successor to the Buyer or affiliate of such successor, or other consideration (as applicable, the “Substitute Consideration”), so long as such Substitute Consideration has, in the good faith judgment of the Board of Directors of the Buyer a value and liquidity equal to or greater than the value of such shares of Common Stock that may otherwise become issuable pursuant to this Section 1.5. As used herein, the term “Fundamental Transaction” means the occurrence of a merger, consolidation, share exchange, tender offer, exchange offer or other form of reorganization or business combination in which the Buyer is not the surviving corporation or in which the shares of Common Stock are deregistered under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”). Buyer hereby represents that, as of the Closing Date, no future Fundamental Transaction is contemplated, it has no current plan or intention to effect a Fundamental Transaction and it has not had any discussions or negotiations to effect a Fundamental Transaction in the future.

 

- 6 -
 

 

CONFIDENTIAL

 

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.  

 

1.6.            Further Assurances. Each of the parties hereto, before, at, and after the Closing, upon the reasonable request from time to time of the other party hereto and without further consideration, will do each and every reasonable act and thing as may be necessary or reasonably desirable to consummate the transactions contemplated hereby and to effect an orderly transfer to the Buyer of the Purchased Assets and the assumption by Buyer of the Assumed Liabilities, including without limitation: executing, acknowledging, and delivering assurances, assignments, powers of attorney, and other documents and instruments; furnishing information and copies of documents, books, and records; filing reports, returns, applications, filings, and other documents and instruments provided by Buyer with governmental authorities; in the case of Seller, transferring to the Buyer patents, patent applications and the like held by the Seller that relate to the Patents; turning over to the Buyer all mail and communications in the Seller’s possession or control related to the Purchased Assets; and cooperating with the other party hereto (at such other party’s expense) in exercising any right or pursuing any claim, whether by litigation or otherwise, other than rights and claims running against the party from whom or which such cooperation is requested. If either party shall receive any payment that pursuant to this Agreement is the property of the other party, then the party receiving such payment shall promptly turn such payment over to the other party and until such time shall hold it in trust for the other party. The Buyer shall pay any applicable assignment, recordal fees, or other fees payable for the recordal of the assignment of any Patents or any other Purchased Assets or for the filing of any other reports, returns, applications and other documents requested by Buyer.

1.7.            Consent of Third Parties . On the Closing Date, Seller shall assign to Buyer, and Buyer will assume, the Assigned Contracts, in each case, to the extent permitted by, and in accordance with, applicable law. Notwithstanding anything to the contrary contained in this Agreement, if the assignment or assumption of all or any portion of any rights or obligations under any Assigned Contract shall require the consent of any other party thereto that has not been obtained prior to the Closing Date, this Agreement shall not constitute an agreement to assign or otherwise transfer any rights or obligations under such Assigned Contract. In order, however, to seek to provide Buyer the full realization and value of every such Assigned Contract, (a) as soon as practicable after the Closing, Seller and Buyer shall cooperate in all reasonable respects to obtain the consent to the assignment of such Assigned Contract; provided , that neither party shall be required to make any payment or agree to any material undertakings in connection therewith.

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CONFIDENTIAL

 

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.              Closing; Deliveries at Closing .

2.1.           Preparation for Closing. Each of the parties hereto shall use its commercially reasonable good faith efforts to bring about the fulfillment of the conditions precedent contained in this Agreement, including without limitation the obtaining, of all necessary consents, approvals, and waivers for the consummation of the transactions contemplated by this Agreement.

2.2.           Closing . The closing of the transactions (the “ Transaction ”) contemplated hereby (the “ Closing ”) shall be held at the offices of the Buyer, on September 3, 2014, or such other date, time and place as shall be agreed upon by the Seller and the Buyer, subject to satisfaction or waiver of the conditions set forth in Sections 5 and 7 hereof (the actual date of the Closing being referred to as the “ Closing Date ”).

2.3.           Deliveries at Closing. At the Closing, (i) the Buyer shall deliver the Initial Payment and the Registration Rights Agreement specified in Section 5 , duly executed by the Company; and (ii) the Seller shall deliver to the Buyer the Registration Rights Agreement and the instruments of conveyance specified in Section 5 , duly executed by the Seller.

3.              Representations of Seller . Except as disclosed on Schedule 3 , the Seller represents and warrants to the Buyer as follows:

3.1.           Due Incorporation and Good Standing. The Seller is a corporation duly incorporated, validly existing, and in good standing under the laws of Delaware, and has the requisite corporate power and authority to own its properties and to carry on its business as now being conducted. The Seller is qualified as a foreign corporation authorized to transact business and is in good standing in the State of Pennsylvania.

3.2.           Authorization; Enforcement; Validity. The Seller has the requisite corporate power and authority to enter into to enter into, execute, deliver, and perform this Agreement, any other agreements relating to the transactions contemplated hereby, any instruments of transfer and conveyance and the Registration Rights Agreement (collectively, with this Agreement, the “ Transaction Documents ”) to which the Seller is party, and to consummate all transactions contemplated hereby and thereby and has taken all corporate action required by law and its Certificate of Incorporation, bylaws and shareholder agreements to authorize such execution, delivery, and performance. This Agreement is, and each of the other Transaction Documents to which the Seller is a party will, upon execution by a duly authorized officer of Seller, be the valid and legally binding obligation of Seller, enforceable against Seller in accordance with its terms, except (i) as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of creditors rights and remedies or by other equitable principles of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies, and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.

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CONFIDENTIAL

 

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.

 

3.3.            No Violation or Approval. The execution, delivery, and performance of this Agreement and the other Transaction Documents to which it will be a party and the consummation of the transactions contemplated hereby and thereby will not result in a breach or violation of, or a default under, (i) the Seller’s Certificate of Incorporation, bylaws, any shareholder agreements or (ii) any statute applicable to it, any agreement to which it is a party or by which it or any of its properties are bound, or (iii) any order, judgment, decree, rule, or regulation of any court or any governmental agency or body having jurisdiction over it or its properties, except in the case of each of clauses (ii) and (iii), such as would not, individually or in the aggregate, have or reasonably be expected to result in a material adverse effect on any of (A) the business, properties, assets, operations, results of operations or financial condition of Seller, taken as a whole, or (B) the authority or ability of Seller to perform its obligations under this Agreement (a “ Seller Material Adverse Effect ”). Other than filings to be made on or after the Closing Date in connection with the Closing, no consent, approval, order, or authorization of, or declaration or filing with, any governmental authority is required of, and has not been obtained or made by, the Seller in connection with the execution and delivery of this Agreement and the other Transaction Documents or the consummation of the transactions contemplated hereby and thereby, except where the failure to obtain such consent, approval, order, authorization or to make such declaration or filing would not have a Seller Material Adverse Effect.

3.4.            Title to Purchased Assets. The Seller owns, leases, licenses, or has the right to use all of the Purchased Assets and at the Closing Buyer acquire good title or the right to use the Purchased Assets to the Buyer free and clear of all liens, claims, and encumbrances (“ Liens ”).

3.5.           Intellectual Property .

3.5.1.          Schedule 1.1.2 lists all of the Patents, identifying in each case whether such Patents are owned by the Seller or in-licensed by the Seller and, if in-licensed, whether such in-license is exclusive or non-exclusive, the inventors/authors listed in the application, status, filing date, and issuance/registration/grant date, and prosecution status thereof.

 

3.5.2.          Seller exclusively owns (both legally and beneficially) all of the rights, title and interest in and to, or is a licensee of, the Patents free from all Liens. The information concerning the Patents set forth in Schedule 1.1.2 is complete and accurate in all material respects. The Seller has not granted any license, consent, permission or other right or privilege under Patents. The Patents listed on Schedule 1.1.2 include all patent rights currently owned or licensed by the Seller or its affiliates relating to the Product. The rights granted by the Seller herein do not conflict with any agreement of the Seller with a third party pertaining to the Patents.

 

3.5.3.          To the Seller’s Knowledge, the Patents listed on Schedule 1.1.2 are subsisting, in full force and effect, are valid and enforceable, and have not expired or been cancelled or abandoned. To the Seller’s Knowledge, all necessary registration, maintenance and renewal fees currently due have been made, and all necessary documents, recordations and certificates have been filed, for the purposes of maintaining such Patents. The Seller has not received any written notice of invalidity or unenforceability of the Patents, has not received written notice of receipt by the licensor of any written notice of invalidity or unenforceability of the Patents that is licensed to the Seller, and, to the Knowledge of the Seller, no basis exists for invalidity or unenforceability of the Patents that is licensed to the Seller. For the purposes of this Agreement, when used in the case of the Seller, the term “Knowledge” shall mean the actual knowledge of Robert J. Capetola, Ph.D., who is the Chief Executive Officer of the Seller, and all other officers and directors of the Seller.

 

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CONFIDENTIAL

 

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.

 

3.5.4.          Neither the Seller nor its affiliates have received any written notice from any third party stating any ground on which any such Patents could be invalidated, precluded from registration (in their current form, in the case of applications), revoked or precluded from enforcement or on which the Seller’s ownership of such Patents could be challenged. None of the Patents is the subject of any litigation, arbitration, opposition or other registry, court or administrative proceeding.

 

3.5.5.          No licenses, agreements, consents, permissions, estoppels, waivers, obligations or restrictions have been entered into by the Seller which entitle any third party to use, or which affect the ownership or, to the Knowledge of the Seller, enforceability (including without limitation remedies available on successful enforcement), of the Patents, other than this Agreement.

 

3.5.6.          To the Seller’s Knowledge, no third party is infringing or making unauthorized use of, or has infringed or made unauthorized use of any of the Patents. To the Seller’s Knowledge, none of the activities respecting the Product of the Seller and/or its affiliates infringe or make unauthorized use of, or have in the preceding three years infringed or made unauthorized use of, the intellectual property rights of any third party and the Seller has not received any written notice from any third party that the activities of the Seller or its affiliates with respect to the Product infringe or make unauthorized use of the intellectual property rights of any third party.

 

3.6.           Regulatory Issues .

3.6.1.          To the Seller’s Knowledge, all of the studies, tests and pre-clinical and clinical trials of the Products conducted prior to, or being conducted as of, the date hereof were conducted, or are being conducted, in accordance with applicable laws in all material respects, and in the case of clinical trials, the then valid Current Good Clinical Practices . The Seller’s registration with any Regulatory Authorities, including the FDA, and the EMA, in respect of the Product, and all supporting documentation, materials, correspondence, and information filed by it with any Regulatory Authorities, is in compliance in all material respects with all applicable laws and all rules applied by such Regulatory Authorities, including with respect to accuracy of filings with such Regulatory Authorities.

 

3.6.2.          To the Seller’s Knowledge, there are no investigations, inquiries, actions or other proceedings (including without limitation any clinical holds) pending before or threatened by any regulatory or governmental authority with respect to the Product, other than any proceedings to conduct clinical trials or obtain approval of the Product. The Seller has not received written notice threatening any such investigation, inquiry, action or other proceeding (including without limitation any clinical holds) anywhere in the world.

 

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CONFIDENTIAL

 

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.

 

3.6.3.          The Seller has disclosed in writing or made available to the Buyer all material information and data (including without limitation all communications with or from the FDA or any other Regulatory Authorities) respecting the results of all pre-clinical and clinical studies of the Product conducted by or on behalf of the Seller including, without limitation, with respect to the status and interim results of ongoing clinical and preclinical studies and approval activities. In addition, none of the information provided or made available to the Buyer has lead the Seller to conclude that the Product will not be approved by the FDA or other Regulatory Authorities; provided that nothing in this Section 3.6.3 constitutes a guarantee that the Product will be approved by the FDA or other Regulatory Authorities.

 

3.6.4.          There are no monetary obligations owing to Regulatory Authorities with respect to the Product as of the Closing Date.

 

3.7.           Absence of Certain Changes or Events . Except for the execution and delivery of this Agreement and the transaction contemplated hereby, since March 31, 2014, the Seller has conducted its business in the ordinary course and in a manner consistent with past practice and, since such date, there has not been:

3.7.1.          any Seller Material Adverse Effect;

 

3.7.2.          any damage, destruction or loss (whether or not covered by insurance) with respect to any Purchased Assets;

 

3.7.3.          any change by Seller in its accounting methods, principles or practices;

 

3.7.4.          any liability incurred in connection with the Purchased Assets, other than such items incurred or entered into in the ordinary course of business and in a manner consistent with past practice; or

 

3.7.5.          any license, sale, transfer, pledge, mortgage or other disposition of any tangible or intangible asset of the Seller respecting the Purchased Assets other than the sale of inventory in the ordinary course of business and in a manner consistent with past practice and the sale of assets that were replaced by assets of comparable use, quality, quantity and value.

 

3.8.           Certain Contracts and Arrangements .

3.8.1.          Except as set forth on Schedule 3.8.1 , Seller is not a party to nor bound by any written or oral:

 

     3.8.1.1. contract or any other document respecting any of the Purchased Assets; or

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CONFIDENTIAL

 

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. 

 

     3.8.1.2. license, whether as licensor or licensee, of any invention (whether patented or not) respecting the Purchased Assets;

3.8.2.          (i) Each contract required to be set forth on Schedule 3.8.1 (including all amendments and modifications thereof) is, to the Seller’s Knowledge, in full force and effect and is legal, valid and binding and enforceable in accordance with its terms against each other party to such contract and (ii) neither the Seller nor to Seller’s Knowledge any other party to any contract required to be set forth on Schedule 3.8.1 is in breach thereof or default thereunder, and to the Knowledge of the Seller no event or circumstance has occurred that with the passage of time or giving of notice is likely to result in a breach or default.

 

3.8.3.          The Seller has delivered to the Buyer true, correct and complete copies of each contract required to be set forth on Schedule 3.8.1 and provided on Schedule 3.8.1 a true, correct and complete description of all oral contracts required to be set forth on Schedule 3.8.1 .

 

3.9.            Litigation . There is no order or action, suit, litigation, proceeding, arbitration, investigation, review, claim, complaint, petition, investigation or demand (collectively, “ Actions ”) pending, or to the Knowledge of the Seller, threatened, before any “Governmental Entity” (as defined below) or arbitrator, relating directly or indirectly to (a) the Purchased Assets, (b) the Seller or (c) the transactions contemplated hereunder, except for those proceedings by Regulatory Authorities described in Section 1.1.5 of this Agreement. To the Knowledge of Seller, there exists no factual basis for any such Action “ Governmental Entity ” means any foreign, domestic, federal, territorial, national, state, multi-state, municipal or other local governmental authority, any executive, legislative, or judicial branch of such authority, any court, official, board, subdivision, agency, department, branch, instrumentality, commission or authority thereof, or any quasi-governmental or private self-regulatory body exercising any regulatory or taxing authority.

3.10.         Compliance with Law, Permits and Licenses . The Seller has complied with all laws applicable to the Seller, except for those failures to comply as would not, individually or in the aggregate, have or reasonably be expected to result in a Seller Material Adverse Effect. Seller has not received any notice of any asserted, and the Seller has no Knowledge of any event or circumstance that with or without the passage of time or the giving of notice or both is likely to result in a, violation of any law, except for those violations which would not, individually or in the aggregate, have or reasonably be expected to result in a Seller Material Adverse Effect.

3.11.         Brokers, Finders, Etc . All negotiations relating to this Agreement and the transactions contemplated hereby have been carried on without the intervention of any person acting on behalf of the Seller in such manner as to give rise to any valid claim against the Seller or the Buyer for any brokerage or finder’s commission, fee, or similar compensation.

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CONFIDENTIAL

 

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. 

 

3.12.         Investment Intent . The Seller is acquiring the Shares as principal for its own account for investment purposes only and not with a view to or for distributing or reselling such Shares or any part thereof, without prejudice, however, to the Seller’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. Subject to the immediately preceding sentence, nothing contained herein shall be deemed a representation or warranty by the Seller to hold the Shares for any period of time. The Seller does not have any agreement or understanding, directly or indirectly, with any person or entity to distribute any of the Shares.

3.13.         Accredited Investor Status . At the time the Seller was offered the Shares, it was, and at the date hereof it is an “accredited investor” as defined in Rule 501(a) under the Securities Act of 1933, as amended (the “ Securities Act ”).

3.14.         General Solicitation . The Seller is not acquiring the Shares as a result of any advertisement, article, notice or other communication regarding the Shares published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general solicitation or general advertisement.

3.15.         Access to Information . The Seller acknowledges that it has reviewed the reports that the Company has filed with the Commission under the Securities Act and the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), including pursuant to Section 13(a) or 15(d) thereof (collectively, the “ Disclosure Materials ”), and has been afforded (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the Company and the merits and risks of acquiring the Shares; (ii) access to information about the Company and its subsidiaries and their respective financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate the acquisition of the Shares; and (iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary to make an informed decision with respect to the acquisition of the Shares.

3.16.        Tax .

3.16.1.      The Seller has timely filed all tax returns required to be filed and all taxes owed (whether or not shown or required to be shown on such tax returns) have been paid or remitted. All such tax returns were true, complete and correct in all material respects. No portion of any tax return has been the subject of any audit, action, suit, proceeding, claim or examination by any Governmental Entity, and no such audit, action, suit, proceeding, claim, deficiency or assessment is pending or, to the Knowledge of the Seller, threatened. Seller is not currently the beneficiary of any extension of time within which to file any tax return, and the Seller has not waived any statute of limitation with respect to any tax or agreed to any extension of time with respect to a tax assessment, or deficiency. No claim has ever been made by a Governmental Entity in a jurisdiction where the Seller does not file tax returns that it is or may be subject to taxation by that jurisdiction. There are no Liens for taxes upon the Purchased Assets other than for taxes not yet due.

 

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CONFIDENTIAL

 

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. 

 

3.16.2.        The Seller has withheld and paid all taxes required to have been withheld and paid in connection with amounts paid or owing to any employee, stockholder, independent contractor, creditor, or other third party.

 

3.16.3.        No state of facts exists or has existed that would constitute grounds for the assessment against the Buyer, whether by reason of transferee liability or otherwise, of any liability for any tax of anyone other than the Buyer.

 

3.16.4.        The Seller has timely paid all taxes, and all interest and penalties due thereon and payable by it, for the pre-Closing tax period which will have been required to be paid on or prior to the Closing Date, the non-payment of which would result in a Lien on any Purchased Asset or would result in the Buyer becoming liable or responsible therefor.

 

3.16.5.        The Seller has established, in accordance with generally accepted accounting principles applied on a basis consistent with that of preceding periods, adequate reserves for the payment of, and will timely pay, all taxes which arise from or with respect to the Purchased Assets incurred in or attributable to the pre-Closing tax period, the non-payment of which would result in a Lien on any Purchased Asset or would result in the Buyer becoming liable therefor.

 

3.17.         Insurance . Schedule 3.17 lists the insurance policies maintained by or on behalf of the Seller and respecting the Purchased Assets, indicating the type of coverage, the name of the insured, name of the insurance carrier or underwriter, premium thereon, policy limits and the period of effectiveness of each policy and sets forth a list of (a) all claims asserted under such policies, (b) any coverage denied with respect to such claims, (c) all payments made under such policies to the Seller or third parties with respect to such claims and (d) the deductibles paid with respect to such claims, in each case, for the previous three (3) years. Except as set forth on Schedule 3.17 , each of such policies is issued in favor of the Seller and is in full force and effect, no claims have been made thereunder that remain outstanding or that were denied, and no casualty has occurred that is likely to give rise to a claim and for which a claim has not yet been made.

3.18.         Seller Employees .

3.18.1.        Seller: (i) is in compliance in all material respects with all laws relating to the employment of labor, including all such laws relating to wages, hours, collective bargaining, discrimination, civil rights, occupational safety and health, workers’ compensation, statutory pension schemes, statutory workers’ compensation schemes and the collection and payment of withholding and/or social security taxes and other taxes; (ii) has withheld and reported all amounts required by law or contract to be withheld and reported with respect to wages, salaries and other payments to all employees of the Seller primarily involved in the operation of the Seller’s business (the “ Seller Employees ”); (iii) is not liable for any arrears of wages or any taxes or any penalty for failure to comply with any of the foregoing; and (iv) is not liable for any payment to any trust or other fund governed by or maintained by or on behalf of any Governmental Entity or arbitrator having jurisdiction over the Purchased Assets, with respect to unemployment compensation benefits, social security or other benefits or obligations for the Seller Employees (other than routine payments to be made in the normal course of business and consistent with past practice).

 

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CONFIDENTIAL

 

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.

 

3.18.2.      There are no pending, or to the Seller’s Knowledge, threatened Actions against the Seller under any worker’s compensation policy or long-term disability policy involving any Seller Employee.

 

3.18.3.      There are no Actions or grievances pending, or, to the Seller’s Knowledge, threatened relating to any labor, safety or discrimination matters involving any Seller Employee, including, charges of unfair labor practices or discrimination complaints.

 

3.19.         Environmental . The Seller has conducted and is now conducting its operations in compliance in all material respects with all applicable federal, state, and local environmental, health and safety and employee protection laws, rules, regulations, the common law, orders, consent agreements and other legal requirements.

3.20.         Related Party Transactions . Since March 31, 2014, no current or former director, officer, employee or equity holder (or any family member of the foregoing) of the Seller has had a business relationship, other than in their capacity as a director, officer, employee or equity holder, with the Seller or has any interest in any Purchased Asset.

3.21.         Absence of Questionable Payments; Business Relationships .

3.21.1        To the Knowledge of Seller, neither the Seller nor any director, officer, agent or employee of the Seller has (i) used any funds of Seller or other funds for unlawful contributions, payments, gifts or entertainment, or made any unlawful expenditures relating to political activity to government officials or others or established or maintained any unlawful or unrecorded funds in violation of Section 104 of the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §78dd-2), as amended, or any other applicable foreign, federal, or state law; or (ii) accepted or received any unlawful contributions, payments, expenditures or gifts.

 

3.21.2        To the Knowledge of Seller, the Seller has not been a customer or supplier or other business relationship with, and is not a party to any contract with, any person organized or domiciled in or that is a citizen of, any country (including any Governmental Authority within any such country) that appears on the Specially Designated Nationals and Blocked Persons List of the Office of Foreign Assets Controls in the United States Department of the Treasury, or in the Annexes to the United States Executive Order 13224 – Blocking Property and Prohibiting Transactions with Person Who Commit, Threaten to Commit, or Support Terrorism

3.22.         Disclosure .

3.23.        No representation or warranty by the Seller contained in this Agreement, the Schedules, the Exhibits hereto nor any written statement or certificate furnished or to be furnished by the Seller to the Buyer in connection herewith or pursuant hereto contains or will contain any untrue statement of a material fact, or omits or will omit to state any material fact required to make the statements contained herein or therein, in light of the circumstances under which they are made, not misleading.

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CONFIDENTIAL

 

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.

3.23.         Solvency .

3.23.1.        The Seller is not now insolvent and will not be rendered insolvent by any of the transactions contemplated hereby. As used in this Section, “insolvent” means the sum of the debts and other probable liabilities of the Seller exceeds the present fair saleable value of the Seller’s assets.

 

3.23.2.       Immediately after giving effect to the consummation of the transactions contemplated hereby: (i) the Seller will be able to pay its liabilities as they become due in the usual course of its business; (ii) the Seller will not have unreasonably small capital with which to conduct its present or proposed business; (iii) the Seller will have assets (calculated at fair market value) that exceed its liabilities; and (iv) taking into account all pending and threatened Actions, final judgments against the Seller in Actions for money damages are not reasonably anticipated to be rendered at a time when, or in amounts such that, the Seller will be unable to satisfy any such judgments promptly in accordance with their terms (taking into account the maximum probable amount of such judgments in any such Actions and the earliest reasonable time at which such judgments might be rendered) as well as all other liabilities of the Seller.

 

3.24.         Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS SECTION 3, NEITHER SELLER NOT ANY OF ITS OFFICERS, DIRECTORS, EMPLOYEES OR REPRESENTATIVES MAKES OR HAS MADE ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, WRITTEN OR ORAL, AT LAW OR IN EQUITY, IN RESPECT OF (i) MERCHANTABILITY, SUITABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, (ii) THE LIKELIHOOD OF OBTAINING REGULATORY APPROVAL FOR THE PRODUCT, OR (iii) THE PROBABLE SUCCESS OR PROFITABILITY OF THE PRODUCT. 

4.               Representations of Buyer . The Buyer represents and warrants to the Seller as follows:

4.1.           Due Incorporation and Good Standing. The Buyer is a corporation duly incorporated, validly existing and in good standing under the laws of Delaware, and has the requisite corporate power and authority to own its properties and to carry on its business as now being conducted. The Buyer is qualified as a foreign corporation authorized to transact business and is in good standing in the State of New Jersey.

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CONFIDENTIAL

 

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.

 

4.2.           Authorization; Enforcement; Validity . The Buyer has the requisite corporate power and authority to enter into, execute, deliver, and perform this Agreement and the other Transaction Documents to which it is a party and to consummate all transactions contemplated hereby and thereby and has taken all action required by law and its Certificate of Incorporation and bylaws to authorize such execution, delivery, and performance. This Agreement is, and each of the other Transaction Documents to which the Buyer is a party, will, upon execution thereof by a duly authorized officer thereof, be the valid and legally binding obligation of the Buyer, enforceable in accordance with its terms, except (i) as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of creditors rights and remedies or by other equitable principles of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies, and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.

4.3.           No Violation or Approval. The execution, delivery, and performance of this Agreement and the other Transaction Documents to which it will be a party and the consummation of the transactions contemplated hereby and thereby will not result in a breach or violation of, or a default under, the Buyer’s Certificate of Incorporation and bylaws, any agreement to which it is a party or by which it or any of its properties are bound, or any order, judgment or decree, of any court or any governmental agency or body having jurisdiction over it or its properties; except in the case of each of clauses (ii) and (iii), such as would not, individually or in the aggregate, have or reasonably be expected to result in a material adverse effect on any of (A) the business, properties, assets, operations, results of operations or financial condition of Seller, taken as a whole, or (B) the authority or ability of the Buyer to perform its obligations under this Agreement (a “ Buyer Material Adverse Effect ”). No consent, approval, order, or authorization of, or declaration or filing with, any governmental authority or other entity is required of, and has not been obtained or made by, the Buyer in connection with the execution and delivery of this Agreement and the other Transaction Documents or the consummation of the transactions contemplated hereby and thereby, other than (i) where the failure to obtain such consent, approval, order, authorization or to make such declaration or filing would not have a Buyer Material Adverse Effect, (ii) the filings required by U.S. federal securities law, including the filing with the U.S. Securities and Exchange Commission (the “ Commission ”) of one or more registration statements in accordance with Section 2 of the Registration Rights Agreement, (iii) filings required by state securities laws, and the timely filing of a Notice of Sale of Securities on Form D with the Commission, and (iv) those that have been or will be made or obtained prior to the Closing Date.

4.4.           Issuance of Securities. The shares of Common Stock comprising a portion of the Purchase Price (the “ Shares ”) have been duly authorized and, when issued in accordance with this Agreement, will be duly and validly issued, fully paid and nonassessable, free and clear of all liens and encumbrances, other than restrictions on transfer under applicable securities laws.

4.5.           Certain Registration Matters . Assuming the accuracy of the Seller’s representations and warranties set forth in Sections 3.12-3.15 , no registration under the Securities Act is required for the issuance and sale of the Shares by the Company to the Seller hereunder.

4.6.           Brokers, Finders, etc. All negotiations relating to this Agreement and the transactions contemplated hereby have been carried on without the intervention of any person acting on behalf of the Buyer in such manner as to give rise to any valid claim against the Seller or the Buyer for any brokerage or finder’s commission, fee, or similar compensation.

- 17 -
 

 

CONFIDENTIAL

 

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.

 

4.7.           Buyer SEC Documents; Financial Statements. Since December 31, 2012, the Buyer has filed with or otherwise furnished to (as applicable) the Securities and Exchange Commission ( the “ SEC ”) all registration statements, prospectuses, forms, reports, definitive proxy statements, schedules and documents required to be filed or furnished by it under the Securities Act or the Exchange Act, as the case may be, together with all certifications required pursuant to the Sarbanes-Oxley Act of 2002, as amended (the “ Sarbanes-Oxley Act ”) (such documents and any other documents filed by the Company with the SEC, as have been supplemented, modified or amended since the time of filing, collectively, the “ Buyer SEC Documents ”). As of their respective filing dates or, if supplemented, modified or amended since the time of filing, as of the date of the most recent supplement, modification or amendment, the Buyer SEC Documents (i) did not at the time each such document was filed 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 made therein, in light of the circumstances under which they were made, not misleading and (ii) complied in all material respects with all applicable requirements of the Exchange Act or the Securities Act, as the case may be, and the Sarbanes-Oxley Act, and the rules and regulations promulgated thereunder, in each case as in effect on the date each such document was filed. As of the date hereof, there are no material outstanding or unresolved comments received from the SEC with respect to any of the reports filed by the Buyer with the SEC. The audited consolidated financial statements and unaudited consolidated interim financial statements of the Buyer (including, in each case, any notes thereto) included in or incorporated by reference into the Buyer SEC Documents (collectively, the “ Buyer Financial Statements ”) (x) complied as of their respective dates of filing in all material respects with the then applicable accounting requirements and the published rules and regulations of the SEC with respect thereto, (y) were prepared in conformity with GAAP (as in effect in the United States on the date of such Buyer Financial Statement) applied on a consistent basis during the periods involved (except as may be indicated in the notes thereto or, in the case of interim financial statements, for normal and recurring year-end adjustments that were not (or will not be) material in amount or effect) and (z) present fairly, in all material respects, the financial position of the Buyer and its consolidated subsidiaries and the results of their operations and their cash flows as of the dates and for the periods referred to therein (except as may be indicated in the notes thereto or, in the case of interim financial statements, for normal and recurring year-end adjustments that were not (or will not be) material in amount or effect).

4.8.           Disclosure. No representation or warranty by the Buyer contained in this Agreement, the Schedules, the Exhibits hereto nor written statement or any certificate furnished or to be furnished by the Buyer to the Seller under this Agreement contains or will contain any untrue statement of a material fact, or omits or will omit to state any material fact required to make the statements contained herein or therein, in light of the circumstances under which they are made, not misleading.

- 18 -
 

 

CONFIDENTIAL

 

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.

 

5.              Compliance With Securities Laws .

5.1.           Restriction on Transfer . The Shares may only be disposed of in compliance with state and federal securities laws. In connection with any transfer of the Shares other than pursuant to an effective registration statement, to the Company or to an “Affiliate” (as defined in Rule 144(a)(1) promulgated under the Securities Act) of the transferor, the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor, reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Shares under the Securities Act.

5.2.           Restrictive Legend . The certificate(s) representing the Shares, until such time as they are not required under Section 5.3 , shall bear the following or substantially similar restrictive legend:

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ SECURITIES ACT ”), OR UNDER ANY APPLICABLE STATE SECURITIES LAWS, AND NEITHER THIS WARRANT NOR ANY SUCH SECURITIES MAY BE OFFERED, SOLD, ASSIGNED, PLEDGED, HYPOTHECATED, TRANSFERRED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR AN EXEMPTION FROM REGISTRATION THEREUNDER AND IN ACCORDANCE WITH ALL APPLICABLE STATE SECURITIES LAWS.

5.3.           Certificates evidencing the Shares shall not contain any legend (including the legend set forth in Section 5.2 ): (i) following a sale of such Shares pursuant to an effective registration statement (including the Registration Statement), (ii) following a sale of such Shares pursuant to Rule 144 (assuming the transferor is not an Affiliate of the Company), (iii) while such Shares are eligible for sale under Rule 144(b)(1) promulgated by the Commission pursuant to the Securities Act or (iv) as soon as reasonably practicable following the receipt by the Company of a written request from the holder thereof; provided that the request is received at least six month’s following the date that such Shares are issued pursuant to this Agreement. Following such time as restrictive legends are not required to be placed on certificates representing the Shares pursuant to the preceding sentence, the Company will, no later than ten (10) days following the delivery by the holder to the Company or the Company’s transfer agent of a certificate representing Shares containing a restrictive legend, deliver or cause to be delivered to such holder a certificate representing such Shares that is free from all restrictive and other legends.

6.              Conditions Precedent to the Obligations of Buyer . The obligations of the Buyer to purchase the Purchased Assets and to consummate the other transactions contemplated hereby and by the other Transaction Documents are subject to the satisfaction on or prior to the Closing Date of each of the following conditions, unless expressly waived by the Buyer at the Closing:

6.1.           Representations and Warranties. The representations and warranties made by the Seller in this Agreement (including the Exhibits and Schedules hereto), except for those specifically made as of a particular date, shall be true and correct in all material respects as of the Closing Date as if made on and as of the Closing Date.

- 19 -
 

 

CONFIDENTIAL

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.

 

6.2.           Bill of Sale, Assignment and Assumption Agreement. The Seller shall have executed and delivered a bill of sale (“ Bill of Sale ”) in the form attached hereto as Exhibit 6.2(a) and an assignment and assumption agreement (“ Assignment and Assumption Agreement ”) in the form attached hereto as Exhibit 6.2(b) conveying to the Buyer all of the Purchased Assets and transferring to the Buyer the Assigned Contracts to be assumed and assigned to the Buyer as of the Closing Date.

6.3.           Registration Rights Agreement . The Seller shall have executed and delivered a Registration Rights Agreement (“ Registration Rights Agreement ”) in the form attached hereto as Exhibit 6.3 .

6.4.           Patents. The Seller shall have executed and delivered to the Buyer an Assignment of Patents in the form attached hereto as Exhibit 6.4 assigning the Patents to the Buyer.

6.5.           No Injunction . No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction that prohibits the consummation of any of the transactions contemplated by the Transaction Documents.

6.6.           Performance . The Seller shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the Transaction Documents to be performed, satisfied or complied with by it at or prior to the Closing.

6.7.           Letters to Regulatory Authorities . The Seller shall have delivered to the Buyer a letter(s) from the Seller to any and all Regulatory Authorities, duly executed by the Seller, transferring, or notifying such Regulatory Authorities of the transfer of, as appropriate, the rights to the Purchased Assets to Buyer, in forms reasonably satisfactory to Buyer (which shall be similar in form and substance to the letter set forth on Exhibit 6.7 ).

6.8.           Letters to Third Party Vendors . The Seller shall have delivered to the Buyer a letter(s) from the Seller to any and all third party vendors or contract manufacturers listed on Schedule 1.1.14 , duly executed by the Seller, notifying such parties of the transfer of the rights to the Purchased Assets to Buyer, in forms reasonably satisfactory to Buyer.

6.9.           Releases of Encumbrances . The Seller shall have obtained and delivered to the Buyer lien releases from any and all parties that have any Liens on any of the Purchased Assets, including, without limitation, duly executed termination statements which, when filed with the appropriate Regulatory Authorities, will terminate all financing statements or other Liens on the Purchased Assets.

6.10.        General. The Buyer shall have received counterpart originals, or certified or other copies, of all documents, including without limitation records of corporate proceedings, that it may reasonably request in connection therewith.

- 20 -
 

 

CONFIDENTIAL

 

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.              Conditions Precedent to Obligations of Seller . The Seller’s obligations to sell the Purchased Assets to the Buyer and to consummate the other transactions contemplated hereby and by the other Transaction Documents are subject to the satisfaction on or prior to the Closing Date of each of the following conditions, unless expressly waived by the Seller at or prior to the Closing:

7.1.           Representations and Warranties. The representations and warranties made by the Buyer in this Agreement, except for those specifically made as of a particular date, shall be true and correct in all material respects as of the Closing Date.

7.2.           Payment Acknowledgment, Assignment and Assumption Agreements. The Buyer shall have paid the Initial Payment to the Seller and shall have executed and delivered to the Seller the Assignment and Assumption Agreement.

7.3.           Registration Rights Agreement . The Buyer shall have executed and delivered the Registration Rights Agreement.

7.4.           No Injunction . No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction that prohibits the consummation of any of the transactions contemplated by the Transaction Documents.

7.5.           Performance . The Buyer shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the Transaction Documents to be performed, satisfied or complied with by it at or prior to the Closing.

7.6.           Letters to Regulatory Authorities . The Buyer shall have delivered to the Seller a letter(s) from the Buyer to any and all applicable Regulatory Authorities, duly executed by the Buyer, assuming responsibilities for ongoing obligations related to the Purchased Assets, in forms reasonably satisfactory to Seller.

8.              Covenants of the Parties .

8.1.           Access to Premises, Information, and Contracting Parties. From and after the date hereof, through the Closing Date, the Seller will permit the Buyer and its authorized representatives to have reasonable access during normal operating hours to the Records in possession of the Seller respecting the Product. In addition, prior to or after the Closing Date, the Seller will permit authorized representatives and professionals of the Buyer reasonable access during normal operating hours to all management personnel, offices, and books and records of the Seller respecting the Product, and the Buyer shall (at its expense) be permitted to make abstracts from, or copies of, all such books and records. The Seller shall reasonably cooperate with the Buyer to assist the Buyer to contact counterparties to the Seller’s material contracts related to the Product, including manufacturers, packagers, and licensors.

- 21 -
 

 

CONFIDENTIAL

 

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.

 

8.2.           Preservation of Purchased Assets Prior to Transfer of Purchased Assets. Prior to the transfer of the Purchased Assets to the Buyer, the Seller will not (a) license, sell, or lease or enter into any contract for the license, sale, or lease of any Purchased Asset to any person or entity, or (b) amend, terminate, or modify any material licenses, registrations, or applications of or respecting the Patents or the Product. The Seller will operate its business with respect to the Product in the usual, regular, and ordinary course of business in all material respects.

8.3.           Confidential Information . Each party shall treat in confidence all documents, materials, and other information obtained (whether obtained before or after the date of this Agreement) regarding the other party, its business or assets during the course of the negotiations of the transactions contemplated hereby and the preparation of this Agreement, the Transaction Documents, and other related documents (“ Confidential Information ”). The term “Confidential Information” shall not include any (a) information which is or becomes public or available to the general public otherwise than through a breach of the terms of this Agreement; (b) information obtained by the receiving party on a non-confidential basis from a third party who was not known to the receiving party to be prohibited from disclosing such information pursuant to a legal, contractual or fiduciary obligation to the disclosing party; (c) information developed independently by the receiving party without use of information of the disclosing party as shown by the receiving party’s written evidence; or (d) i nformation which the receiving party is lawfully required to disclose by law, rule, applicable regulation, interrogatories, subpoenas, civil investigative demands or other similar legal process, stock exchange rules or disclosure requirement of a governmental authority , provided that the receiving party shall promptly notify the disclosing party of such requirement, shall disclose only that portion of the Information which, based on the written opinion of its counsel, is legally required to be disclosed, and shall use its best efforts to obtain confidential treatment for such Information; or (e) information approved for release by written authorization of the disclosing party. Confidential Information shall not be communicated to any third person (other than to each party’s respective counsel, accountants, financial advisors, and investors and other necessary parties on a “need to know” basis only). No party shall use any Confidential Information in any manner whatsoever except solely for the negotiations of the transactions contemplated hereby and the purposes of this Agreement; provided , however, that, after the Closing, the Buyer may use or disclose any Confidential Information included in the Purchased Assets. After the Closing, (i) all Confidential Information relating to the Purchased Assets shall be deemed to be the Confidential Information of the Buyer for purposes of this Section 8.3 and shall be held in confidence by the Seller and its affiliates after the Closing Date pursuant to the requirements set forth herein; and (ii) all Confidential Information relating to the Purchased Assets that is retained by the Seller after the Closing Date shall be maintained in confidence by the Seller and its affiliates in the same manner as the Seller and its affiliates treat their other confidential information.

8.4.           No Public Announcement . Except as provided herein, neither the Seller nor the Buyer shall, without the approval of the other, make any press release or other public announcement regarding the transactions contemplated by this Agreement, except as and to the extent that any such party is so obligated by applicable law, in which case the other party shall be advised and the parties shall use their best efforts to cause a mutually agreeable release or announcement to be issued; provided that the foregoing shall not preclude communications or disclosures necessary to (i) implement the provisions of this Agreement; or (ii) comply with accounting obligations or applicable law or judicial process. Upon closing of the transactions hereunder, the Buyer shall have the right to issue a press release, which is in form and substance reasonably acceptable to the Seller.

- 22 -
 

 

CONFIDENTIAL

 

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.

 

8.5.           Satisfaction of Excluded Liabilities and Assumed Liabilities. After the Closing, the Seller shall pay, perform and discharge, or otherwise satisfy, when due all of the Excluded Liabilities and the Buyer shall pay, perform and discharge, or otherwise satisfy, when due all of the Assumed Liabilities.

8.6.           Survival of Representations and Warranties . The representations and warranties set forth in this Agreement (and in any Schedule or Exhibit attached hereto or certificate delivered in connection with the Closing) will be true and correct as of the time of Closing, but shall not survive after the Closing, except that the representations and warranties contained in Sections 3.1, 4.1, and 4.4 shall be true and correct as of the time of Closing and shall survive until the expiration of the applicable statute of limitations period. For clarification, no representation or warranty shall be required to be maintained as true and correct after the Closing. The covenants and obligations set forth in this Agreement, and the Seller’s obligations with respect to the Excluded Liabilities will survive the Closing until fully performed in accordance with their terms. All claims for actual fraud shall survive the Closing hereunder until barred by the applicable statute of limitations.

8.7.           Tax Reporting . The parties intend for the consummation of the transactions contemplated by this Agreement to qualify as to the Seller and its shareholders as a tax free reorganization under Section 368(a)(1)(C) of the Internal Revenue Code of 1986, as amended. Each party agrees to not take any position inconsistent with this tax treatment in any returns, reports, or other filings it may make with the Internal Revenue Service.

8.8.           Liquidation . The Seller shall liquidate and dissolve no later than 12 months after the Closing, and pursuant to such liquidation and dissolution, shall distribute, after the payment of any liabilities, to its shareholders all of the Purchase Price and any Excluded Assets (the “Liquidation”). The shareholders of the Seller shall be responsible for the preparation and the timely filing of all Tax Returns of the Seller. The sale and assignment of the Purchased Assets pursuant to this Agreement and the Liquidation are intended to constitute integrated steps in a single “plan of reorganization” within the meaning of Treas. Reg. §§ 1.368-2(g) and 1.368-3, which plan of reorganization the parties hereby adopt by executing this Agreement. 

9.              Limitations on Liability .

9.1.           Definitions . For the purposes of this section, the following terms shall have the following meanings:

9.1.1.          Claim ” means any actual or threatened civil, criminal, administrative, regulatory, arbitral or investigative inquiry, action, suit, investigation or proceeding and any claim or demand resulting therefrom or any other actual or threatened claim or demand of whatever nature or kind.

 

- 23 -
 

 

CONFIDENTIAL

 

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.

 

9.1.2.          Losses ” means all damages, fines, penalties, deficiencies, losses, liabilities (whether accrued, actual, contingent, latent or otherwise), costs, fees and expenses (including interest, court costs and reasonable fees and expenses of lawyers, accountants and other experts and professionals).

 

9.2.           Limitation . Other than with respect to any Claims for fraud, the Seller’s liability for all Claims made or Losses incurred, by the Buyer directly or indirectly relating to the provisions of this Agreement or the transactions contemplated hereunder, whether at law, under any statute or in equity (including Claims for contribution or other rights of recovery arising under any applicable law, Claims for breach of contract, breach of representation and warranty, negligent representation and all Claims for breach of duty), or otherwise, shall not exceed the Purchase Price.

10.            Miscellaneous .

10.1.        Notices . All notices, demands, consents or other communications which any party may be required or may desire to give under this Agreement shall be in writing and shall be deemed to have been duly given (i) upon receipt if mailed by certified mail, return receipt requested, postage prepaid, (ii) one business day after prepaid deposit with a reputable overnight delivery service, or (iii) upon receipt if delivered by telecopy or email, the receipt of confirmation by sender being conclusive evidence of such receipt, in any case to the party to whom the same is so given or made at the address of such party as set forth below.

To Seller:                                          Hy BioPharma, Inc.

2500 York Road

Jamison, Pennsylvania 18929

Facsimile: 215-918-3339

Email: rcapetola@yahoo.com

Attention: Robert J. Capetola, CEO

 

with a copy to:                                 Buchanan Ingersoll & Rooney PC

Two Liberty Place

50 S. 16th Street, Suite 3200

Philadelphia, PA 19102-2555

Facsimile: (215) 665-8760

Email: brian.north@bipc.com

Attn: Brian S. North

 

To Buyer:                                         Soligenix, Inc.

29 Emmons Drive

Suite C-10 Princeton, NJ 08540 

Facsimile: (609) 452-6467

Email: cschaber@soligenix.com

Attn: Christopher J. Schaber, Ph.D., President and CEO

 

- 24 -
 

 

CONFIDENTIAL

 

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:                                 Duane Morris LLP

200 South Biscayne Blvd., Suite 3400

Miami, Florida 33131-2318

Facsimile: 305-397-1882

Email: ljcroland@duanemorris.com

Attention: Leslie J. Croland

 

Notice to a party’s counsel only will not constitute notice to such party.

 

10.2.         Risk of Loss . The risk of loss or damage to the Purchased Assets shall be upon the Seller at all times prior to the Closing.

10.3.         Entire Agreement . The agreement of the parties that is comprised of this Agreement, the Exhibits and Schedules hereto, and the other documents referred to herein sets forth the entire agreement and understanding between the parties and supersedes any prior written agreement or understanding and any prior or contemporaneous oral agreement or undertaking relating to the subject matter of this Agreement, except as specifically contemplated by Sections 10 and 13 of the Option Agreement. This Agreement may not be amended or modified except by a written agreement duly executed by each of the parties hereto.

10.4.         Assignment . This Agreement shall be binding upon and inure to the benefit of and be enforceable by the successors and assigns of the Seller and the Buyer. This Agreement and any rights hereunder shall not be assigned or transferred by any party hereto without the prior written consent of the other party.

10.5.         Governing Law . This Agreement shall be governed by and construed in accordance with the law of the State of Delaware, without giving effect to any choice or conflict of law provision or rule that would cause the application of the law of any other jurisdiction.

10.6.         No Third Party Beneficiaries . Nothing in this Agreement is intended or shall be construed to give any person or entity, other than the parties hereto, any legal or equitable right, remedy, or claim under or in respect of this Agreement or any provision contained herein or in any Schedule or Exhibit attached hereto.

10.7.         No Liability of Officers and Directors . The parties hereto acknowledge that any individual executing this Agreement or any certificates or other documents contemplated by this Agreement on behalf of the Buyer or the Seller do so on behalf of such entities and not in their individual capacities. As such, no officer, director, employee, or agent of the Buyer or the Seller shall have any liability hereunder.

10.8.         Counterparts . This Agreement may be executed in any number of counterparts, each of which shall be deemed an original for all purposes and all of which together shall constitute one and the same instrument.

10.9.         Headings . The headings contained in this Agreement are inserted only as a matter of convenience and for reference and in no way define, limit, or describe the scope or intent of this Agreement.

{signature page follows}

- 25 -
 

CONFIDENTIAL

 

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 Seller and the Buyer have caused this Agreement to be executed under seal by their respective duly authorized officers as of the day and year first written above.

  Hy BioPharma, Inc.
     
  By: /s/ Robert J. Capetola
  Name: Robert J. Capetola, Ph.D.
  Title: CEO
     
  Soligenix, Inc.
     
  By: /s/ Christopher J. Schaber
  Name:   Christopher J. Schaber, Ph.D.
  Title:   President and CEO

- 26 -
 

 

CONFIDENTIAL

 

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 1.1.2

 

PATENTS

 

  1.    Issued Patents
a. Use of Photo-activated Hypericin (U.S. Patent 6,001,882) - Expires 2022 with 5-year extension; Covers CTCL and Psoriasis (Hy BioPharma does not own this patent. Rights under this patent are covered by the License Agreement dated July 23, 2006, as amended on January 18, 2013 and April 17, 2014, among the Seller, New York University and Yeda Research and Development Company Ltd.)

 

b. Methods of Preparing Hypericin (U.S. Patent 8,629,302) – Expires 2029.

 

  1.   Patent Applications
a. European Patent Application (11777830.8), 4/20/2011; Formulations and Methods of Treatment of Skin Conditions*

 

b. U.S. Non-Provisional Application Serial No. 13/605,902, filed November 2, 2012 and claiming priority to U.S. Provisional Application Serial No. 61/331,131 filed May 4, 2010 and PCT/US2011/033161 filed April 20, 2011*

_______________

* [*****].

 

.

CONFIDENTIAL

 

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 1.1.7

 

PRECLINICAL TESTING, STUDIES AND CLINICAL TRIALS

[*****]

 

 

 

CONFIDENTIAL

 

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 1.1.12

 

ASSIGNED CONTRACTS

 

  1. License Agreement dated July 23, 2006, as amended on January 18, 2013 and April 17, 2014, among the Seller, New York University and Yeda Research and Development Company Ltd.

 

 

CONFIDENTIAL

 

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 1.1.13

 

INVENTORY

 

None.

 

 


 

CONFIDENTIAL

 

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 1.1.14

 

Vendors

 

Frontage Laboratories

 

 

 

CONFIDENTIAL

 

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 3

EXCEPTIONS TO REPRESENTATIONS AND WARRANTIES

 

The Seller is not qualified as a foreign corporation authorized to do business in the Commonwealth of Pennsylvania and is not in good standing in the Commonwealth of Pennsylvania.

 

[*****]

 

The Seller has not made royalty payments due under the License Agreement identified in Schedule 1.1.12 in the aggregate amount of $100,000.

 

 

 

CONFIDENTIAL

 

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 3.8.1

 

CONTRACTS RELATING TO PURCHASED ASSETS

 

License Agreement dated July 23, 2006, as amended on January 18, 2013 and April 17, 2014, among the Seller, New York University and Yeda Research and Development Company Ltd.

 

 

 

CONFIDENTIAL

 

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 3.17

 

INSURANCE

 

None.

 

 

 

 

EXHIBIT 10.2

 

REGISTRATION RIGHTS AGREEMENT

 

This Registration Rights Agreement (this “ Agreement ”) is made and entered into as of September 3, 2014, between Soligenix, Inc., a Delaware corporation (the “ Company ”), and Hy BioPharma, Inc., a Delaware corporation (the “ Investor ”).

 

Recital

 

A.            This Agreement is made pursuant to the Exclusive Option to Purchase Assets dated as of April 1, 2014 by and between the Company and the Investor (the “ Option Agreement ”) and the Asset Purchase Agreement, dated as of the date hereof between the Company and the Investor (the “ Purchase Agreement ”).

 

The Company and the Investor hereby agree as follows:

 

1.              Definitions . Capitalized terms used and not otherwise defined herein that are defined in the Purchase Agreement shall have the meanings given such terms in the Purchase Agreement. As used in this Agreement, the following terms shall have the following meanings:

 

Advice ” shall have the meaning set forth in Section 6(c) .

 

Common Stock ” means the common stock of the Company, par value $.001 per share, and any securities into which such common stock may hereafter be classified.

 

Effectiveness Date ” means, (a) with respect to the Registration Statement required to be filed hereunder with respect to the Option Shares, November 5, 2014, (b) with respect to the initial Registration Statement required to be filed hereunder with respect to the Shares, the date that is 180 days following the date of issuance of such Registrable Securities, and (c) with respect to any additional Registration Statement(s) that may be required pursuant to Section 2(b) , the earlier of (i) the 30th calendar day following (x) the first date or time that such Registrable Securities may then be included in a Registration Statement, if such Registration Statement is required because the Commission shall have notified the Company in writing that certain Registrable Securities were not eligible for inclusion on a previously filed Registration Statement, or (y) the date on which the Company first knows, or reasonably should have known, that such additional Registration Statement(s) is required if such Registration Statement is required for a reason other than as described in (x) above, and (ii) the fifth Trading Day following the date on which the Company is notified by the Commission that such additional Registration Statement will not be reviewed or is no longer subject to further review and comments.

 

  Effectiveness Period ” shall have the meaning set forth in Section 2(a) .

 

Holder ” or “ Holders ” means the holder or holders, as the case may be, from time to time of Registrable Securities.

 

Indemnified Party ” shall have the meaning set forth in Section 5(c) .

 

 

 

Indemnifying Party ” shall have the meaning set forth in Section 5(c) .

 

Losses ” shall have the meaning set forth in Section 5(a) .

 

Option Shares ” shall have the meaning set forth in the Option Agreement.

 

Proceeding ” means an action, claim, suit, investigation or proceeding (including, without limitation, an investigation or partial proceeding, such as a deposition), whether commenced or threatened.

 

Prospectus ” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by the Registration Statement, and all other amendments and supplements to the Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

 

Registrable Securities ” means all of the Option Shares and the Shares, together with any shares of Common Stock issued or issuable upon any stock split, dividend or other distribution, recapitalization or similar event with respect to the foregoing.

 

Registration Statement ” means the registration statement(s) required to be filed hereunder, including (in each case) the Prospectus, amendments and supplements to such registration statement(s) or Prospectus, including pre- and post-effective amendments, all exhibits thereto, and all material incorporated by reference or deemed to be incorporated by reference in such registration statement(s).

 

Rule 415 ” means Rule 415 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.

 

Rule 424 ” means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.

 

Trading Day ” means (i) a day on which the Common Stock is traded in the over-the-counter market, as reported by OTC Markets Group, Inc., or (ii) if the Common Stock is not quoted by OTC Markets Group, Inc., a day on which the Common Stock is quoted in the over-the-counter market as reported by the National Quotation Bureau Incorporated (or any similar organization or agency succeeding to its functions of reporting prices); provided, that in the event that the Common Stock is not listed or quoted as set forth in (i) and (ii) hereof, then Trading Day shall mean a Business Day.

 

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2.              Registration .

 

(a)            The Company shall as soon as reasonably practicable prepare and file with the Commission a Registration Statement covering the resale of all of the Registrable Securities for an offering to be made on a continuous basis pursuant to Rule 415. The Registration Statement required hereunder shall be on Form S-1 (except if the Company is not then eligible to register for resale the Registrable Securities on Form S-1, in which case the Registration shall be on another appropriate form in accordance herewith). The Registration Statement required hereunder shall contain (except if otherwise directed by the Holders) the “ Plan of Distribution ” attached hereto as Annex A . Subject to the terms of this Agreement, the Company shall use its best efforts to cause the Registration Statement to be declared effective under the Securities Act as promptly as possible after the filing thereof, but in any event not later than the Effectiveness Date, and shall use its best efforts to keep the Registration Statement continuously effective under the Securities Act until the earlier of: (i) the date when all Registrable Securities covered by the Registration Statement have been sold, (ii) when all Registrable Securities covered by the Registration Statement may be sold without volume restrictions pursuant to Rule 144(b)(i) promulgated under the Securities Act, and (iii) one year from the date of issuance of the applicable Registrable Securities (the “ Effectiveness Period ”).

 

(b)            If for any reason the Commission does not permit all of the Shares to be included in the Registration Statement filed pursuant to Section 2(a) , then the Registrable Securities that are included in such offering shall be allocated among the Holders in proportion (as nearly as practicable) to the number of Registrable Securities owned by each Holder, or in such other proportions as shall mutually be agreed to by all such Holders. To facilitate the allocation of shares in accordance with the above provisions, the Company may round the number of shares allocated to any Holder to the nearest 100 shares. If for any reason the Commission does not permit all of the Shares to be included in the Registration Statement filed pursuant to Section 2(a) or for any other reason any Registrable Securities are not then included in a Registration Statement filed under this Agreement, then the Company shall prepare and file as soon as possible after the date on which such filing may be made an additional Registration Statement covering the resale of all Registrable Securities not already covered by an existing and effective Registration Statement for an offering to be made on a continuous basis pursuant to Rule 415. Each such Registration Statement shall contain (except if otherwise directed by the Holders) the “Plan of Distribution” attached hereto as Annex A . The Company shall use its best efforts to cause each such Registration Statement to be declared effective under the Securities Act as soon as possible but, in any event, no later than its Effectiveness Date, and shall use its best efforts to keep such Registration Statement continuously effective under the Securities Act during its entire Effectiveness Period.

 

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(c)             Notwithstanding anything to the contrary contained in this Agreement, in the event the staff of the Commission (the “ Staff ”) or the Commission requires any Holder seeking to sell securities under a Registration Statement filed pursuant to this Agreement to be specifically identified as an “underwriter” in order to permit such Registration Statement to become effective, and such Holder does not consent to being so named as an underwriter in such Registration Statement, then in each such case, the Company shall reduce the total number of Registrable Securities to be registered on behalf of such Holder, until such time as the Staff or the Commission does not require such identification or until such Holder accepts such identification and the manner thereof. In the event of any reduction pursuant to this Section 2(c) , no Holder shall have any claim against the Company as a result of such reduction. In the event of any reduction in Registrable Securities pursuant to this Section 2(c) , an affected Holder shall have the right to require, upon delivery of a written request to the Company signed by the Holder, the Company to file a registration statement within 30 days of such request (subject to any restrictions imposed by Rule 415 or required by the Staff or the Commission) for re-sale by such Holder in a manner acceptable to such Holder, and the Company shall following such request cause to be and keep effective such registration statement in the same manner as otherwise contemplated in this Agreement for registration statements hereunder, in each case until the earlier of such time as: (i) all Registrable Securities held by such Holder have been registered pursuant to an effective Registration Statement in a manner acceptable to such Holder or (ii) the Registrable Securities may be resold by such Holder without restriction (including volume limitations) pursuant to Rule 144(b)(i) of the Securities Act (taking account of any Staff position with respect to “affiliate” status) or (iii) one year from the date of issuance of the applicable Registrable Securities or (iv) the Holder agrees to be named as an underwriter in any such Registration Statement in a manner acceptable to Holder as to all Registrable Securities held by such Holder and that have not theretofore been included in a Registration Statement under this Agreement (it being understood that the special demand right under this sentence may be exercised by a Holder multiple times and with respect to limited amounts of Registrable Securities in order to permit the re-sale thereof by such Holder as contemplated above).

 

(d)             By 5:30 p.m. on the Trading Day immediately following the Effective Date of each Registration Statement, the Company shall file with the Commission in accordance with Rule 424 under the Securities Act the final prospectus to be used in connection with sales pursuant to such Registration Statement.

 

3.              Registration Procedures

 

In connection with the Company's registration obligations hereunder, the Company shall:

 

(a)            Not less than three Trading Days prior to the filing of a Registration Statement or any related Prospectus or any amendment or supplement thereto, the Company shall furnish to the Holders copies of the “Selling Stockholders” and the “Plan of Distribution” sections and any risk factor contained in such document that addresses specifically this transaction or the Selling Stockholders, as proposed to be filed which documents will be subject to the review of such Holders.

 

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(b)             (i) Prepare and file with the Commission such amendments, including post-effective amendments, to the Registration Statement and the Prospectus used in connection therewith as may be necessary to keep the Registration Statement continuously effective as to the applicable Registrable Securities for the Effectiveness Period and prepare and file with the Commission such additional Registration Statements in order to register for resale under the Securities Act all of the Registrable Securities; (ii) cause the related Prospectus to be amended or supplemented by any required Prospectus supplement, and as so supplemented or amended to be filed pursuant to Rule 424; (iii) respond as promptly as reasonably possible to any comments received from the Commission with respect to the Registration Statement or any amendment thereto and, as promptly as reasonably possible, upon request, provide the Holders true and complete copies of all correspondence from and to the Commission relating to the Registration Statement; and (iv) comply in all material respects with the provisions of the Securities Act and the Exchange Act with respect to the disposition of all Registrable Securities covered by the Registration Statement (to the extent such provisions are applicable to the Company). Notwithstanding anything else contained herein to the contrary, the Company shall not provide any material, nonpublic information to the Holders. The Company shall ensure that each Registration Statement (including any amendments or supplements or prospectuses contained therein) shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary to make the statements therein (in the case of prospectuses, in light of the circumstances in which they were made) not misleading.

 

(c)            Notify the Holders of Registrable Securities as promptly as reasonably possible (and, in the case of (i)(A) below, not less than two Trading Days prior to such filing) and (if requested by any such Person) confirm such notice in writing promptly following the day (i)(A) when a Prospectus or any Prospectus supplement or post-effective amendment to the Registration Statement is proposed to be filed; (B) when the Commission notifies the Company whether there will be a “review” of the Registration Statement and whenever the Commission comments in writing on the Registration Statement (the Company shall provide copies thereof and all written responses thereto to each of the Holders to the extent such materials address the Selling Stockholder or Plan of Distribution sections of the Registration Statement, and to the extent they address risk factors or other disclosures in such Registration Statement particular to the Holder or the transactions contemplated hereby); and (C) with respect to the Registration Statement or any post-effective amendment, when the same has become effective; (ii) of any request by the Commission or any other Federal or state governmental authority during the period of effectiveness of the Registration Statement for amendments or supplements to the Registration Statement or Prospectus or for additional information; (iii) of the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement covering any or all of the Registrable Securities or the initiation of any Proceedings for that purpose; (iv) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction, or the initiation or threatening of any Proceeding for such purpose; and (v) of the occurrence of any event or passage of time that makes the financial statements included in the Registration Statement ineligible for inclusion therein or any statement made in the Registration Statement or Prospectus or any document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires any revisions to the Registration Statement, Prospectus or other documents so that, in the case of the Registration Statement or the Prospectus, as the case may be, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. The Company shall submit a request for acceleration of the Registration Statement to the Commission, within two (2) Trading Days after the date the Company learns that no review of a particular Registration Statement will be made by the Staff or Commission or that the Staff has no further comments on a Registration Statement.

 

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(d)            Use reasonable best efforts to avoid the issuance of, or, if issued, obtain the withdrawal of (i) any order suspending the effectiveness of the Registration Statement, or (ii) any suspension of the qualification (or exemption from qualification) of any of the Registrable Securities for sale in any jurisdiction, at the earliest practicable moment.

 

(e)            Deliver to each Holder, by 5:30 p.m. (Eastern time) on the second day following the Effective Date, without charge, as many copies of the Prospectus or Prospectuses (including each form of prospectus) and each amendment or supplement thereto as such Persons may reasonably request in connection with resales by the Holder of Registrable Securities. Subject to the terms of this Agreement, the Company hereby consents to the use of such Prospectus and each amendment or supplement thereto by each of the selling Holders in connection with the offering and sale of the Registrable Securities covered by such Prospectus and any amendment or supplement thereto, subject to notices pursuant to Section 3(c) .

 

(f)            Prior to any resale of Registrable Securities by a Holder, use its commercially reasonable efforts to register or qualify or cooperate with the selling Holders in connection with the registration or qualification (or exemption from the Registration or qualification) of such Registrable Securities for the resale by the Holder under the securities or “Blue Sky” laws of such jurisdictions within the United States as any Holder reasonably requests in writing, to keep the Registration or qualification (or exemption therefrom) effective during the Effectiveness Period and to do any and all other acts or things reasonably necessary to enable the disposition in such jurisdictions of the Registrable Securities covered by the Registration Statement; provided , that the Company shall not be required to qualify generally to do business or file a general consent to service of process in any jurisdiction where it is not then so qualified.

 

(g)            If requested by the Holders, cooperate with each Holder to facilitate the timely preparation and delivery of certificates representing Registrable Securities to be delivered to a transferee pursuant to the Registration Statement, which certificates shall be free, to the extent permitted by the Purchase Agreement, of all restrictive legends, and to enable such Registrable Securities to be in such denominations and registered in such names as any such Holders may request.

 

(h)            Upon the occurrence of any event contemplated by this Section 3 , as promptly as commercially reasonably possible under the circumstances taking into account the good faith determination of the Company’s Board of Directors of adverse consequences to the Company and its stockholders of the premature disclosure of material non-public information, prepare a supplement or amendment, including a post-effective amendment, to the Registration Statement or a supplement to the related Prospectus or any document incorporated or deemed to be incorporated therein by reference, and file any other required document so that, as thereafter delivered, neither the Registration Statement nor such Prospectus will contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. If the Company notifies the Holders in accordance with clauses (ii) through (v) of Section 3(c) above to suspend the use of any Prospectus until the requisite changes to such Prospectus have been made, then the Holders shall suspend use of such Prospectus. The Company will use its best efforts to ensure that the use of the Prospectus may be resumed as promptly as is commercially practicable. The Company shall be entitled to exercise its right under this Section 3(h) to suspend the availability of a Registration Statement and Prospectus for a period not to exceed a period of 30 consecutive days and for no more than an aggregate of 60 days (which need not be consecutive days) in any 12 month period. The Company shall not be entitled to exercise its right under this Section 3(h) during the first 30 Trading Days after a Registration Statement is declared effective by the Commission.

 

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(i)            Comply with all applicable rules and regulations of the Commission.

 

(j)            Each Holder agrees to furnish to the Company a completed Questionnaire in the form attached to this Agreement as Annex B (a “ Selling Holder Questionnaire ”). The Company shall not be required to include the Registrable Securities of a Holder in a Registration Statement who fails to furnish to the Company a fully completed Selling Holder Questionnaire at least one Trading Day prior to the filing of a Registration Statement or any related Prospectus or any amendment or supplement thereto (subject to the requirements set forth in Section 3(a)) .

 

(k)            Upon notification by the Commission that a Registration Statement will not be reviewed or is no longer subject to further review and comments, the Company shall request acceleration of such Registration Statement such that it becomes effective at 5:00 p.m. (New York City time) on the second (2nd) Trading Day following receipt of such notification.

 

(l)            If requested by a Holder, the Company shall as soon as practicable after receipt of notice from such Holder, use reasonable best efforts to (i) incorporate in a prospectus supplement or post-effective amendment such information as a Holder reasonably requests to be included therein relating to the sale and distribution of Registrable Securities, including, without limitation, information with respect to the number of Registrable Securities being offered or sold, the purchase price being paid therefor and any other terms of the offering of the Registrable Securities to be sold in such offering; (ii) make all required filings of such prospectus supplement or post-effective amendment after being notified of the matters to be incorporated in such prospectus supplement or post-effective amendment; and (iii) supplement or make amendments to any Registration Statement if reasonably requested by a Holder holding any Registrable Securities.

 

(m)            The Company shall make generally available to its security holders as soon as practical, but not later than 90 days after the close of the period covered thereby, an earnings statement (in form complying with, and in the manner provided by, the provisions of Rule 158 under the 1933 Act) covering a twelve-month period beginning not later than the first day of the Company’s fiscal quarter next following the Effective Date of the Registration Statement or any additional registration statement required by the terms of this Agreement.

 

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4.             Registration Expenses . All fees and expenses incident to the performance of or compliance with this Agreement by the Company shall be borne by the Company whether or not any Registrable Securities are sold pursuant to the Registration Statement. The fees and expenses referred to in the foregoing sentence shall include, without limitation, (i) all registration and filing fees (including, without limitation, fees and expenses in compliance with applicable state securities or Blue Sky laws), (ii) printing expenses (including, without limitation, expenses of printing certificates for Registrable Securities and of printing prospectuses if the printing of prospectuses is reasonably requested by the holders of a majority of the Registrable Securities included in the Registration Statement), (iii) messenger, telephone and delivery expenses, (iv) fees and disbursements of counsel for the Company, (v) Securities Act liability insurance, if the Company so desires such insurance, and (vi) fees and expenses of all other persons or entities retained by the Company in connection with the consummation of the transactions contemplated by this Agreement. In addition, the Company shall be responsible for all of its internal expenses incurred in connection with the consummation of the transactions contemplated by this Agreement (including, without limitation, all salaries and expenses of its officers and employees performing legal or accounting duties), the expense of any audit. In no event shall the Company be responsible for any broker or similar commissions of the Holders.

 

5.             Indemnification

 

(a)             Indemnification by the Company . The Company shall, notwithstanding any termination of this Agreement, indemnify and hold harmless each Holder, the officers, directors, agents employees, and representatives of each of them, each person or entity who controls any such Holder (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act) and the officers, directors, agents and employees of each such controlling person or entity, to the fullest extent permitted by applicable law, from and against any and all losses, claims, damages, liabilities, costs (including, without limitation, reasonable attorneys' fees) and expenses (collectively, “ Losses ”), as incurred, arising out of or relating to (i) any untrue or alleged untrue statement of a material fact contained in the Registration Statement, any Prospectus or any form of prospectus or in any amendment or supplement thereto or in any preliminary prospectus, or arising out of or relating to any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus or form of prospectus or supplement thereto, in light of the circumstances under which they were made) not misleading, except to the extent, but only to the extent, that (A) such untrue statements or omissions are based solely upon information regarding such Holder furnished in writing to the Company by such Holder expressly for use therein, or to the extent that such information relates to such Holder or such Holder's proposed method of distribution of Registrable Securities and was reviewed and expressly approved in writing by such Holder expressly for use in the Registration Statement, such Prospectus or such form of Prospectus or in any amendment or supplement thereto (it being understood that the Holder has approved Annex A hereto for this purpose), (B) in the case of an occurrence of an event of the type specified in Section 3(c)(ii)-(v) , the use by such Holder of an outdated or defective Prospectus after the Company has notified such Holder in writing that the Prospectus is outdated or defective and prior to the receipt by such Holder of the Advice or an amended or supplemented Prospectus, but only if and to the extent that following the receipt of the Advice or the amended or supplemented Prospectus the misstatement or omission giving rise to such Loss would have been corrected and no grounds for such Loss would have existed, or (C) such Holder fails to comply with any applicable prospectus delivery requirements of the Securities Act applicable to it in connection with sales of Registrable Securities pursuant to a Registration Statement or (ii) any violation or alleged violation by the Company of the Securities Act, the Exchange Act, any other law, including, without limitation, any state securities law, or any rule or regulation thereunder relating to the offer or sale of the Registrable Securities pursuant to a Registration Statement.. The Company shall notify the Holders promptly of the institution, threat or assertion of any Proceeding of which the Company is aware in connection with the transactions contemplated by this Agreement. Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of the Indemnified Party and shall survive the transfer of any of the Registrable Securities by any of the Holders.

 

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(b)             Indemnification by Holders . Each Holder shall, severally and not jointly, indemnify and hold harmless the Company, its directors, officers, agents and employees, each person or entity who controls the Company (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, agents or employees of such controlling persons or entities, to the fullest extent permitted by applicable law, from and against all Losses, as incurred, arising solely out of or based solely upon: (x) such Holder's failure to comply with the prospectus delivery requirements of the Securities Act to the extent that delivery of such Prospectus would have avoided such Loss or (y) any untrue or alleged untrue statement of a material fact contained in any Registration Statement, any Prospectus, or any form of prospectus, or in any amendment or supplement thereto or in any preliminary prospectus, or arising solely out of or based solely upon any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein not misleading to the extent, but only to the extent, that such untrue statements or omissions are based solely upon information regarding such Holder furnished in writing to the Company by such Holder expressly for use therein. In no event shall the liability of any selling Holder hereunder be greater in amount than the dollar amount of the net proceeds received by such Holder upon the sale of the Registrable Securities giving rise to such indemnification obligation. The indemnity agreement contained in this Section 6(b) and the agreement with respect to contribution contained in Section 6(d) shall not apply to amounts paid in settlement of any Losses if such settlement is effected without the prior written consent of the applicable Holder, which consent shall not be unreasonably withheld or delayed.

 

(c)            Conduct of Indemnification Proceedings . If any Proceeding shall be brought or asserted against any person or entity entitled to indemnity hereunder (an “ Indemnified Party ”), such Indemnified Party shall promptly notify the person or entity from whom indemnity is sought (the “ Indemnifying Party ”) in writing, and the Indemnifying Party shall have the right to assume the defense thereof, including the employment of counsel reasonably satisfactory to the Indemnified Party and the payment of all fees and expenses incurred in connection with defense thereof; provided, that the failure of any Indemnified Party to give such notice shall not relieve the Indemnifying Party of its obligations or liabilities pursuant to this Agreement, except (and only) to the extent that it shall be finally determined by a court of competent jurisdiction (which determination is not subject to appeal or further review) that such failure shall have proximately and materially prejudiced the Indemnifying Party.

 

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An Indemnified Party shall have the right to employ separate counsel in any such Proceeding and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties unless: (1) the Indemnifying Party has agreed in writing to pay such fees and expenses; (2) the Indemnifying Party shall have failed promptly to assume the defense of such Proceeding and to employ counsel reasonably satisfactory to such Indemnified Party in any such Proceeding; or (3) the named parties to any such Proceeding (including any impleaded parties) include both such Indemnified Party and the Indemnifying Party, and such Indemnified Party shall have been advised by counsel that a conflict of interest is likely to exist if the same counsel were to represent such Indemnified Party and the Indemnifying Party (in which case, if such Indemnified Party notifies the Indemnifying Party in writing that it elects to employ separate counsel at the expense of the Indemnifying Party, the Indemnifying Party shall not have the right to assume the defense thereof and the reasonable fees and expenses of such separate counsel shall be at the expense of the Indemnifying Party). The Indemnifying Party shall not be liable for any settlement of any such Proceeding effected without its written consent, which consent shall not be unreasonably withheld. No Indemnifying Party shall, without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, effect any settlement of any pending Proceeding in respect of which any Indemnified Party is a party, unless such settlement includes an unconditional release of such Indemnified Party from all liability on claims that are the subject matter of such Proceeding.

 

Subject to the terms of this Agreement, all reasonable fees and expenses of the Indemnified Party (including reasonable fees and expenses to the extent incurred in connection with investigating or preparing to defend such Proceeding in a manner not inconsistent with this Section) shall be paid to the Indemnified Party, as incurred, within ten Trading Days of written notice thereof to the Indemnifying Party (regardless of whether it is ultimately determined that an Indemnified Party is not entitled to indemnification hereunder; provided , that such Indemnified Party shall promptly reimburse the Indemnifying Party all such fees and expenses to the extent it is finally judicially determined that such Indemnified Party is not entitled to indemnification hereunder).

 

(d)             Contribution . If a claim for indemnification under Section 5(a) or 5(b) is unavailable to an Indemnified Party (by reason of public policy or otherwise), then each Indemnifying Party, in lieu of indemnifying such Indemnified Party, shall contribute to the amount paid or payable by such Indemnified Party as a result of such Losses, in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party and Indemnified Party in connection with the actions, statements or omissions that resulted in such Losses as well as any other relevant equitable considerations. The relative fault of such Indemnifying Party and Indemnified Party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission of a material fact, has been taken or made by, or relates to information supplied by, such Indemnifying Party or Indemnified Party, and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such action, statement or omission. The amount paid or payable by a party as a result of any Losses shall be deemed to include, subject to the limitations set forth in this Section 5 , any reasonable attorneys’ or other reasonable fees or expenses incurred by such party in connection with any Proceeding to the extent such party would have been indemnified for such fees or expenses if the indemnification provided for in this Section was available to such party in accordance with its terms.

 

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 The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 5(d) were determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to in the immediately preceding paragraph. Notwithstanding the provisions of this Section 5(d), (i) no Holder shall be required to contribute, in the aggregate, any amount in excess of the amount by which the net proceeds actually received by such Holder from the sale of the Registrable Securities subject to the Proceeding exceeds the amount of any damages that such Holder has otherwise been required to pay, or would otherwise be required to pay under Section 5(b), by reason of such untrue or alleged untrue statement or omission or alleged omission; (ii) no contribution shall be made under circumstances where the maker would not have been liable for indemnification under the fault standards set forth in this Section 5 and (iii) no Person involved in the sale of Registrable Securities which Person is guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) in connection with such sale shall be entitled to contribution from any Person involved in such sale of Registrable Securities who was not guilty of fraudulent misrepresentation.

 

The indemnity and contribution agreements contained in this Section are in addition to any liability that the Indemnifying Parties may have to the Indemnified Parties.

 

6.              Reports Under the Exchange Act . With a view to making available to the Holders the benefits of Rule 144 promulgated under the Securities Act or any other similar rule or regulation of the Commission that may at any time permit the Holders to sell securities of the Company to the public without registration, the Company agrees to use reasonable best efforts to:

 

(a)          make and keep public information available, as those terms are understood and defined in Rule 144;

 

(b)          file with the Commission in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act so long as the Company remains subject to such requirements (it being understood that nothing herein shall limit the Company’s obligations under the Purchase Agreement) and the filing of such reports and other documents is required for the applicable provisions of Rule 144;

 

(c)          furnish to each Holder so long as such Holder owns Registrable Securities, promptly upon request, (i) a written statement by the Company, if true, that it has complied with the reporting requirements of Rule 144, the Securities Act and the Exchange Act, (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company if such reports are not publicly available via EDGAR, and (iii) such other information as may be reasonably requested to permit the Holders to sell such securities pursuant to Rule 144 without registration; and

 

(d)          procure the removal of the restrictive legend on the Registrable Securities held by a Holder as soon as reasonably practicable following the receipt by the Company of a request for such removal; provided that the request is received at least six month’s following the date that such Shares are issued pursuant to this Agreement.

11
 

 

 7.             Miscellaneous

 

(a)           Remedies . In the event of a breach by the Company or by a Holder, of any of their obligations under this Agreement, each Holder or the Company, as the case may be, in addition to being entitled to exercise all rights granted by law and under this Agreement, including recovery of damages, will be entitled to specific performance of its rights under this Agreement. The Company and each Holder agree that monetary damages would not provide adequate compensation for any losses incurred by reason of a breach by it of any of the provisions of this Agreement and hereby further agrees that, in the event of any action for specific performance in respect of such breach, it shall waive the defense that a remedy at law would be adequate.

 

(b)             Compliance . Each Holder covenants and agrees that it will comply with the prospectus delivery requirements of the Securities Act as applicable to it in connection with sales of Registrable Securities pursuant to the Registration Statement.

 

(c)             Discontinued Disposition . Each Holder agrees by its acquisition of such Registrable Securities that, upon receipt of a notice from the Company of the occurrence of any event of the kind described in Section 3(c) , such Holder will forthwith discontinue further sales of such Registrable Securities under the Registration Statement until such Holder's receipt of the copies of the supplemented Prospectus and/or amended Registration Statement or until it is advised in writing (the “ Advice ”) by the Company that the use of the applicable Prospectus may be resumed, and, in either case, has received copies of any additional or supplemental filings that are incorporated or deemed to be incorporated by reference in such Prospectus or Registration Statement. The Company will use its best efforts to ensure that the use of the Prospectus may be resumed as promptly as is commercially practicable.

 

(d)            Piggy-Back Registrations.

 

(i)   If at any time during the Effectiveness Period there is not an effective Registration Statement covering all of the Registrable Securities and the Company shall determine to prepare and file with the Commission a registration statement relating to an offering for its own account or the account of others under the Securities Act of any of its equity securities, other than on Form S-4 or Form S-8 (each as promulgated under the Securities Act) or their then equivalents relating to equity securities to be issued solely in connection with any acquisition of any entity or business or equity securities issuable in connection with the stock option or other employee benefit plans, then the Company shall send to each Holder a written notice of such determination and, if within fifteen (15) days after the date of such notice, any such Holder shall so request in writing, the Company shall include in such registration statement all or any part of such Registrable Securities such Holder requests to be registered, subject to customary underwriter cutbacks applicable to all holders of registration rights.

 

(ii)   Except as set forth on Schedule 7(d) attached hereto, neither the Company nor any of its security holders (other than the Holders in such capacity pursuant hereto) may include securities of the Company in a Registration Statement required to be filed hereunder other than the Registrable Securities, provided that no securities set forth on Schedule 7(d) may be included in a Registration Statement if including any such securities would adversely affect any of the Holders. The Company shall not after the date hereof until the initial Effective Date enter into any agreement providing any such right to any of its security holders.

 

12
 

 

(e)            Amendments and Waivers . No provision of this Agreement may be waived or amended except in a written instrument signed by the Company and the Holders holding a majority of the Registrable Securities. No waiver of any default with respect to any provision, condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of either party to exercise any right hereunder in any manner impair the exercise of any such right.

 

(f)             Notices . Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be made in accordance with the provisions of the Purchase Agreement.

 

(g)            Successors and Assigns . This Agreement shall inure to the benefit of and be binding upon the successors and permitted assigns of each of the parties and shall inure to the benefit of each Holder. A Holder may assign any or all of its rights under this Agreement to any person or entity to whom such Holder assigns or transfers any Registrable Securities, provided such transferee agrees in writing to be bound, with respect to the transferred securities, by the provisions hereof that apply to a “Holder.” The Company may not assign its rights or obligations hereunder.

 

(h)             Execution and Counterparts . This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and, all of which taken together shall constitute one and the same Agreement. In the event that any signature is delivered by facsimile or email transmission, such signature shall create a valid binding obligation of the party executing (or on whose behalf such signature is executed) the same with the same force and effect as if such signature were the original thereof.

 

(i)             Governing Law . All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be determined in accordance with the provisions of the Purchase Agreement.

 

(j)             Cumulative Remedies . The remedies provided herein are cumulative and not exclusive of any remedies provided by law.

 

(k)             Severability . If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their reasonable best efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.

 

13
 

 

 

(l)             Headings . The headings in this Agreement are for convenience of reference only and shall not limit or otherwise affect the meaning hereof.

 

(m)           Independent Nature of Holders’ Obligations and Rights . The obligations of each Holder under this Agreement are several and not joint with the obligations of any other Holder, and no Holder shall be responsible in any way for the performance of the obligations of any other Holder under this Agreement. Nothing contained herein and no action taken by any Holder pursuant hereto or thereto, shall be deemed to constitute the Holders as a partnership, an association, a joint venture or any other kind of group or entity, or create a presumption that the Holders are in any way acting in concert or as a group or entity and the Company acknowledges that the Holders are not acting in concert or as a group. Each Holder shall be entitled to independently protect and enforce its rights, including, without limitation, the rights arising out of this Agreement, and it shall not be necessary for any other Holder to be joined as an additional party in any proceeding for such purpose. The use of a single agreement with respect to the obligations of the Company contained herein was solely in the control of the Company, not the action or decision of any Holder, and was done solely for the convenience of the Company and not because it was required or requested to do so by any Holder.

 

(n)             Further Assurances . Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents as any other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.

 

{signature page follows}

 

14
 

 

IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the date first written above.

 

  SOLIGENIX, INC.
     
  By: /s/ Christopher J. Schaber
  Name: Christopher J. Schaber, Ph.D.
  Title:  President & CEO
   
  HY BIOPHARMA, INC.
     
  By: /s/ Robert J. Capetola
  Name: Robert J. Capetola, Ph.D.
  Title: CEO

 

15
 

   

SCHEDULE 7(d)

 

Pursuant to the engagement agreement dated February 6, 2014 (the “Engagement Agreement”) the Company granted Vista Partners LLC rights to include the shares issued thereunder in a Company or investor initiated registration statement.

 

16
 


ANNEX A

 

Plan of Distribution

 

The selling stockholders and any of their pledgees, donees, transferees, assignees and successors-in-interest may, from time to time, sell any or all of their shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These sales may be at fixed or negotiated prices. The selling stockholders may use any one or more of the following methods when selling shares:

 

ordinary brokerage transactions and transactions in which the broker-dealer solicits investors;
block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
an exchange distribution in accordance with the rules of the applicable exchange;
privately negotiated transactions;
broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;
a combination of any such methods of sale; and
any other method permitted pursuant to applicable law.

The selling stockholders may also sell shares under Rule 144 under the Securities Act, if available, rather than under this prospectus.

 

Broker-dealers engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the investor of shares, from the purchaser) in amounts to be negotiated. The selling stockholders do not expect these commissions and discounts to exceed what is customary in the types of transactions involved.

 

The selling stockholders may from time to time pledge or grant a security interest in some or all of the shares owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell shares of common stock from time to time under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus.

 

The selling stockholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

A-1
 

 

 

The selling stockholders and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Discounts, concessions, commissions and similar selling expenses, if any, that can be attributed to the sale of securities will be paid by the selling stockholders and/or the purchasers of the securities.

 

Each selling stockholder that is affiliated with a registered broker-dealer has confirmed to us that, at the time it acquired the securities subject to the registration statement of which this prospectus is a part, it did not have any agreement or understanding, directly or indirectly, with any person to distribute any of such securities.

 

We are required to pay certain fees and expenses incident to the registration of the shares. We have agreed to indemnify the selling stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act. We agreed to keep this prospectus effective until the earlier of (i) such time as all of the shares have been publicly sold and (ii) May 5, 2014.

 

A-2
 

 

ANNEX B

 

SOLIGENIX, INC.

 

Selling Securityholder Questionnaire

 

The undersigned beneficial owner of shares of Common Stock (the “Registrable Securities” ) of Soligenix, Inc. (the “Company” ) understands that the Company has filed or intends to file with the Securities and Exchange Commission a registration statement (the “Registration Statement” ) for the registration and resale under the Securities Act of 1933, as amended (the “Securities Act” ), of the Registrable Securities. This Questionnaire is delivered pursuant to the terms of the Registration Rights Agreement dated as of September 3, 2014 (the “Registration Rights Agreement” ), among the Company and the Investor named therein. A copy of the Registration Rights Agreement is available from the Company upon request at the address set forth below. All capitalized terms not otherwise defined herein shall have the meanings ascribed thereto in the Registration Rights Agreement.

 

Certain legal consequences arise from being named as a selling securityholder in the Registration Statement and the related prospectus. Accordingly, holders and beneficial owners of Registrable Securities are advised to consult their own securities law counsel regarding the consequences of being named or not being named as a selling securityholder in the Registration Statement and the related prospectus.

 

The undersigned beneficial owner (the “Selling Securityholder” ) of Registrable Securities hereby elects to include the Registrable Securities owned by it and listed below in Item 3 (unless otherwise specified under such Item 3) in the Registration Statement.

 

The undersigned hereby provides the following information to the Company and represents and warrants that such information is accurate:

 

1. Name.   
     
   (a) Full Legal Name of Selling Securityholder:
        
        
   (b) Full Legal Name of Registered Holder (if not the same as (a) above) through which Registrable Securities Listed in Item 3 below are held:
        
        
   (c) Full Legal Name of each Control Person (which means a natural person that directly or indirectly has power to vote or dispose of the securities covered by this Questionnaire):
        
        

 

B-1
 

  

2. Address for Notices to Selling Securityholder:

 

  
 
  
 
Telephone: _____________________________________________________________________
Fax: __________________________________________________________________________
Contact Person: _________________________________________________________________

 

 

3. Beneficial Ownership of Registrable Securities:

 

   (a) Type and Principal Amount of Registrable Securities beneficially owned:

 

    
   
    

 

4.  Broker-Dealer Status:

 

   (a) Are you a broker-dealer?

Yes No

 

   Note: If yes, the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement.

 

   (b) Are you an affiliate of a broker-dealer?

Yes No

 

   (c) If you are an affiliate of a broker-dealer, do you certify that you bought the Registrable Securities in the ordinary course of business, and at the time of the purchase of the Registrable Securities to be resold, you had no agreements or understandings, directly or indirectly, with any person to distribute the Registrable Securities?

Yes No

 

   Note: If no, the Commission’s staff has indicated that you should be identified as an underwriter in the Registration Statement.

 

B-2
 

 


5. Beneficial Ownership of Other Securities of the Company Owned by the Selling Securityholder.

 

Except as set forth below in this Item 5, the undersigned is not the beneficial or registered owner of any securities of the Company other than the Registrable Securities listed above in Item 3.

 

     Type and Amount of other Company securities beneficially owned by the Selling Securityholder:

 

      
     

 

6.  Relationships with the Company:

 

Except as set forth below, neither the undersigned nor any of its affiliates, officers, directors or principal equity holders (owners of 5% of more of the equity securities of the undersigned) has held any position or office or has had any other material relationship with the Company (or its predecessors or affiliates) during the past three years.

 

     State any exceptions here:

 

      
     
     
7.   Claims against the Company:

 

Except as set forth below, to the actual knowledge of the undersigned or the officers and directors or persons performing similar functions for the undersigned, neither the undersigned nor any of its Affiliates, officers, directors or principal equity holders (owners of 5% or more of the equity securities of the undersigned) has any claims against the Company, its directors, officers, agents and employees, and each person or entity who controls the Company (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act) relating to the Company’s sale of Registrable Securities to the undersigned.

 

  State any exceptions here:

 

     
     
     

 

The undersigned agrees to promptly notify the Company of any inaccuracies or changes in the information provided herein (other than changes in beneficial ownership of Common Stock after the effectiveness of the Registration Statement) that may occur subsequent to the date hereof at any time prior to the effectiveness of the Registration Statement or while the Registration Statement remains effective.

 

B-3
 

 

 

By signing below, the undersigned consents to the disclosure of the information contained in its answers hereto and the inclusion of such information in the Registration Statement and the related prospectus and any amendments or supplements thereto. The undersigned understands that such information will be relied upon by the Company in connection with the preparation or amendment of the Registration Statement and the related prospectus.

 

IN WITNESS WHEREOF the undersigned, by authority duly given, has caused this Questionnaire to be executed and delivered either in person or by its duly authorized agent.

 

{individual}   {entity}
     
     
Name of Selling Securityholder   Name of Selling Securityholder
     
     
Signature of Selling Securityholder   By
     
     

Name of Selling Securityholder

(if held jointly)

  Name
     
     
Signature of Selling Securityholder (if held jointly)   Title

  

PLEASE FAX A COPY OF THE COMPLETED AND EXECUTED QUESTIONNAIRE, AND RETURN THE ORIGINAL BY OVERNIGHT MAIL, TO:

 

Leslie J. Croland

Duane Morris LLP

200 South Biscayne Boulevard, Suite 3400

Miami, FL 33131-2318

Facsimile: (305) 397-1882

 

B-4


Exhibit 99.1

 

Soligenix Expands Pipeline with Acquisition of

Phase 3-Ready Oncology Clinical Program

 

Newly Acquired SGX301 Orphan Drug Candidate Being Evaluated

for Treatment of Cutaneous T-Cell Lymphoma

 

Princeton, NJ – September 5, 2014 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense , announced today the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin). SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of cutaneous T-cell lymphoma (CTCL) and is highly synergistic with the company’s existing development pipeline . As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data.

 

SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light . This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet A (UVA) exposure. Topical hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, placebo-controlled, clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to topical hypericin treatment compared to only 8.3% receiving placebo (p ≤ 0.04). These clinical data fully support advancing this therapy to a pivotal Phase 3 clinical trial in CTCL. The Phase 3 clinical protocol of SGX301 for the treatment of CTCL is currently in final review with the US Food and Drug Administration (FDA).

 

SGX301 has received orphan drug designation by the FDA for the treatment of CTCL, which provides for 7 years of market exclusivity upon approval in the US. SGX301 is being developed pursuant to discoveries made at New York University Medical Center together with the Yeda Research and Development Company, Ltd., which is the commercial arm of the Weizmann Institute of Science in Rehovot, Israel.

 

In addition to SGX301, the acquired technology package includes preclinical and clinical data supporting other potential indications for hypericin photodynamic therapy, such as psoriasis. Psoriasis is an autoimmune inflammatory disease that is similarly characterized by cutaneous accumulation of T-cell lymphocytes but without cancerous transformation. It is a common disease that affects over 7 million adults in the US. Photodynamic therapy is a frequently employed initial therapy for psoriasis, despite the need for ultraviolet light exposure and its attendant risk of melanoma and non-melanoma skin cancer. The Phase 2 clinical study has shown that hypericin and visible light phototherapy is also effective in treating these lesions.

 

 

 

“We are very excited by the acquisition of this late-stage technology which has the potential to be the first photodynamic therapy approved for CTCL,” stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix. “With SGX301 we will be able to leverage our clinical development expertise in cancer and cancer supportive care. We also anticipate the potential for a number of federal funding opportunities for SGX301 in this orphan disease, as well as for expansion into other indications of unmet medical need.”

 

About CTCL

 

Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mycosis fungoides (MF) is the most common form of CTCL. It generally presents with skin involvement only, manifested as scaly, erythematous patches. Advanced disease with diffuse lymph node and visceral organ involvement is usually associated with a poorer response rate to standard therapies. A relatively uncommon sub-group of CTCL patients present with extensive skin involvement and circulating malignant cerebriform T-cells, referred to as Sézary syndrome. These patients have substantially graver prognoses than those with MF.

With CTCL mortality is related to stage of disease, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Treatment of early-stage disease generally involves skin-directed therapies. Most MF treatments are not approved by the FDA. One of the most common unapproved therapies used for early-stage disease is oral 5 or 8-methoxypsoralen (Psoralen) given with ultraviolet A (UVA) light, referred to as PUVA. Although having demonstrated a level of efficacy, psoralen is a mutagenic chemical that interferes with DNA causing mutations and other malignancies. Moreover, UVA is a carcinogenic light source that when combined with the psoralen, results in serious adverse effects including secondary skin cancers; therefore, the FDA requires a Black Box warning for PUVA.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

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About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Hypericin is also found in several species of Hypericum plants, although the drug used in SGX301 is chemically synthesized by a proprietary manufacturing process and not extracted from plants. Importantly, hypericin is optimally activated with visible light thereby avoiding the negative consequences of ultraviolet light.

 

Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In both settings, it appears that the mode of action is an induction of cell death in a concentration as well as a light dose-dependent fashion. These effects appear to result, in part, from the generation of singlet oxygen during photoactivation of hypericin.

 

Hypericin is one of the most efficient known generators of singlet oxygen, the key intermediate for phototherapy. The generation of singlet oxygen induces necrosis and apoptosis in adjacent cells. The use of topical hypericin coupled with directed visible light results in generation of singlet oxygen only at the required site. The use of visible light (as opposed to cancer-causing ultraviolet light) is a major advance in photodynamic therapy. In a published Phase 2 clinical study in CTCL, patients experienced a significant response with topical hypericin treatment as compared to placebo: 58.3% compared to 8.3% (p ≤ 0.04), respectively.

 

SGX301 has received orphan drug designation from the US FDA. The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven year term of market exclusivity for SGX301 upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for SGX301, and certain tax credits.

 

About Soligenix, Inc.


Soligenix, Inc. is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense . Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec ® ), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.

 

3
 

 

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

 

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com .

 

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

 

Company Contact :

Joe Warusz, CPA

Acting Chief Financial Officer

(609) 538-8200 | www.soligenix.com

Soligenix, Inc.

29 Emmons Drive, Suite C-10

Princeton, NJ 0854

 

4