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) April 20, 2012

 

NEPHROS, INC.

 
(Exact name of registrant as specified in its charter)

  

Delaware

 (State or other jurisdiction of incorporation)

 

  001-32288   13-3971809  
  (Commission File Number)   (IRS Employer ID Number)  
         
  41 Grand Avenue, River Edge, New
Jersey
  07661  
   (Address of principal executive offices)   (Zip Code)  

  

Registrant's telephone number, including area code (201) 343-5202

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

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

 

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

 

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

 

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

 

 

 

1
 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On April 23, 2012, Nephros, Inc. (the “Company”) entered into a license and supply agreement (the “License and Supply Agreement”) with Medica S.p.A. (“Medica”), an Italy-based medical product manufacturing company, for the marketing and sale of certain filtration products based upon Medica’s proprietary Medisulfone ultrafiltration technology in conjunction with the Company’s filtration products (collectively, the “Products”), and to engage in an exclusive supply arrangement for the Products.

 

Under the License and Supply Agreement, Medica granted to the Company an exclusive license, with right of sublicense, to market, promote, distribute, offer for sale and sell the Products worldwide, excluding Italy for the first three years (the “Territory”) during the term of the License and Supply Agreement. In addition, the Company granted to Medica an exclusive license under the Company’s intellectual property to make the Products during the term of the License and Supply Agreement.

 

In exchange for the rights granted, the Company has agreed to make minimum annual aggregate purchases from Medica of €300,000, €500,000 and €750,000 for the years 2012, 2013 and 2014, respectively. For calendar years thereafter, annual minimum amounts will be mutually agreed upon between Medica and the Company. As consideration for the license and other rights granted to the Company, the Company is required to pay Medica installment payments of €500,000 and €1,000,000 on April 23, 2012 and January 25, 2013, respectively. In addition, for the period beginning April 23, 2014 through December 31, 2022, the Company will pay Medica a royalty rate of 3% of net sales of the Products sold, subject to reduction as a result of a supply interruption pursuant to the terms of the License and Supply Agreement. As further consideration for the license and other rights granted to the Company, the Company will grant Medica options to purchase 300,000 shares of the Company’s common stock.

 

The term of the License and Supply Agreement commenced on April 23, 2012 and continues in effect through December 31, 2022, unless earlier terminated by either party in accordance with the terms of the License and Supply Agreement.

 

The description of the License and Supply Agreement set forth above is not complete and is qualified in its entirety by reference to the License and Supply Agreement, which is attached as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

On April 23, 2012, the Company issued a press release announcing its entry into the License and Supply Agreement. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 5.02  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Upon the appointment of John C. Houghton described below, effective April 20, 2012, Paul A. Mieyal resigned as acting Chief Executive Officer, but will remain as a member of the Board of Directors (the “Board”) of the Company.

 

On April 23, 2012, the Company announced the appointment of John C. Houghton (48) as President and Chief Executive Officer of the Company, effective as of April 20, 2012. Mr. Houghton has over 25 years of commercialization experience in the pharmaceutical and medical device fields. He has direct experience in building out global commercial organizations including marketing, sales, sales operations, customer service, business analytics and new product development and has also been directly responsible for successfully licensing products and leading joint ventures and partnerships. Mr. Houghton most recently served as President and CEO of CorMedix Inc. (NYSE-Amex: CRMD), a pharmaceutical company focused on therapeutic products for the treatment of cardio-renal disease. While President and CEO, Mr. Houghton led the acquisition of the company’s product candidates and the completion of its initial public offering. Prior to assuming the role of President and CEO, he was the Chief Business Officer for CorMedix. Before joining CorMedix, Mr. Houghton established the global sales and marketing infrastructure for the Biotech division of Stryker Corp. (NYSE: SYK). Prior to Stryker, he worked with Aventis (NYSE: SNY) and predecessor companies for more than 14 years. During his time at Aventis he led the global marketing of Nasacort, served as commercial lead on the Aventis-Millennium inflammation collaboration, and functioned as the global new products commercialization head for respiratory, inflammation, cardiovascular, and metabolism products. Mr. Houghton received his B.Sc. from Liverpool John Moores University, United Kingdom.

 

On April 23, 2012, the Company issued a press release announcing the appointment of Mr. Houghton. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.

 

On April 24, 2012, the Board approved the appointment of Mr. Houghton to the Board, effective on that date. Mr. Houghton’s initial term will expire at the close of the Company’s annual meeting of stockholders to be held in 2013. Mr. Houghton will not serve on any committees of the Board nor will he be entitled to any additional compensation in connection with his service on the Board.

 

2
 

 

On April 20, 2012, the Company entered into an Employment Agreement (the “Employment Agreement”), effective as of April 20, 2012, with Mr. Houghton. The Employment Agreement has a term of four years, ending on April 20, 2016.

 

The Employment Agreement provides that Mr. Houghton’s annual base salary will be $350,000. Mr. Houghton will be eligible to receive a target discretionary bonus of 30% of annual base salary, as determined by the Company. The targets with respect to the bonus for the year ending December 31, 2012 will be mutually agreed upon between Mr. Houghton and the Compensation Committee of the Board within 60 days following April 20, 2012 and such bonus will be appropriately prorated for such annual period. The targets for each subsequent annual period will be mutually agreed upon at the beginning of each calendar year between Mr. Houghton and the Compensation Committee. Upon execution of the Employment Agreement, the Company granted Mr. Houghton options to purchase 675,000 shares of the Company’s common stock pursuant to the Company’s 2004 Stock Incentive Plan (the “Plan”). In addition, subject to the approval by stockholders of a commensurate increase in shares authorized for issuances under the Plan, the Company will grant Mr. Houghton options to purchase 331,550 shares of the Company’s common stock.

 

Subject to Mr. Houghton meeting and maintaining the director eligibility requirements of the Board, Mr. Houghton will be nominated for election as a director at each stockholders meeting during his employment at which his term as a director would otherwise expire.

 

The description of the Employment Agreement set forth above is not complete and is qualified in its entirety by reference to the Employment Agreement, which is attached as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 5.07. Submission of Matters to a Vote of Security Holders.

 

The 2012 annual meeting of stockholders for Nephros, Inc. was held on April 23, 2012.

 

At the meeting, Nephros stockholders elected two members to our Board of Directors for a term expiring at the annual meeting of stockholders in 2015, as follows:

 

Member   Number of Shares
Voted For
    Number of Shares
Withheld
    Broker Non-Votes  
Arthur H. Amron     5,287,406       164,794       3,394,476  
James S. Scibetta     5,292,702       159,498       3,394,476  

 

At the meeting, Nephros stockholders also ratified the appointment of Rothstein Kass as our independent registered public accounting firm for the fiscal year ending December 31, 2012, as follows:

 

Number of Shares Voted
For
    Number of Shares
Against or Withheld
    Abstentions     Broker Non-Votes  
  8,468,168       366,869       11,639       0  

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
10.1   License and Supply Agreement dated as of April 23, 2012 between Nephros, Inc. and Medica S.p.A.
10.2   Employment Agreement dated as of April 20, 2012 between Nephros, Inc. and John C. Houghton
99.1   Press release dated April 23, 2012 announcing strategic License and Supply Agreement with Medica S.p.A for ultrafiltration products
99.2     Press release dated April 23, 2012 announcing the appointment of John C. Houghton as President and Chief Executive Officer

 

3
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    Nephros, Inc.
     
  By: /s/ Gerald J. Kochanski
Dated:  April 26, 2012   Gerald J. Kochanski
    Chief Financial Officer

 

4

 

Exhibit 10.1

 

LICENSE AND SUPPLY AGREEMENT

 

This LICENSE and SUPPLY AGREEMENT (this “ Agreement ”) is entered into as of April 23, 2012 (the “ Effective Date ”) by and between Nephros, Inc., a Delaware corporation with its principal office at 41 Grand Ave, River Edge, NJ 07661, represented by its Chief Financial Officer Gerald J. Kochanski (“ Nephros ”), and Medica S.p.A., with registered office in Medolla (MO), Via Degli Artigiani, 7 - 41036, represented by its CEO Luciano Fecondini (“ Medica ”), and sometimes herein referred to individually as a “ Party ” and collectively, as the “ Parties ”.

 

RECITALS

 

1.          Medica develops, manufactures, markets and sells ultrafiltration products based in part upon a proprietary ultrafiltration technology

 

2.          Nephros currently markets and sells ultrafiltation products based upon its own proprietary ultrafiltration technology and products based in part upon Medica’s proprietary ultrafiltration technology.

 

3.          Nephros wishes to exclusively market and sell the Medica Products (defined below) on a worldwide basis in conjunction with the Nephros Products (defined below)and Medica wishes to grant such rights to Nephros pursuant to the terms and subject to the conditions set forth in this Agreement.

 

4.          Nephros and Medica wish to enter into an exclusive supply arrangement for the Medica Products and the Nephros Products pursuant to the terms and subject to the conditions set forth in this Agreement and Schedule 3 hereto (the “ Pricing Schedule ”).

 

5.          Nephros and Medica have collaborated to develop and improve certain of the Medica Products and wish to memorialize the rights of the Parties with respect to thereto pursuant to the terms and subject to the conditions set forth in this Agreement.

 

NOW, THEREFORE , in consideration of the foregoing and of the mutual representations, warranties and covenants contained herein, the Parties agree as follows:

 

1.           Definitions

 

1.1       “ Affiliate ” of a Party hereto means any entity which controls, is controlled by or is under common control with, such Party. For purposes of this definition, a Party shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable ownership interest for an entity other than a corporation) or if it has management control of the other entity. Any reference in this Agreement to a Party shall include the Affiliates of that Party (unless the context requires otherwise).

 

1.2       “ Agents ” shall mean any officer, director, employee, agent, subcontractor, or other authorized representative of a Party or Person.

 

1.3       “ Applicable Law ” shall mean: (a) all laws, statutes, constitutions, treaties, rules, regulations, ordinances, codes, guidance, and common law; and (b) all judicial, executive, legislative, administrative or military orders, directives, decrees, injunctions, judgments, Permits, agreements, and other legal requirements, in each case, of, with, or adopted or imposed by any Governmental Authority, now or hereafter in effect and, in each case, as amended from time to time, including, without limitation, any of the foregoing that relate to or govern (i) the manufacture, quality, marketing, sale, promotion, storage handling, distribution or disposal of the Product and (ii) health, safety, industrial hygiene, or sanitation.

 

 
 

 

1.4       “ cGMP ” means the current applicable regulatory requirements for current good manufacturing practices promulgated by the FDA applicable to the Products as well as those required by other Regulatory Authorities in the Territory, as the same may be amended from time to time.

 

1.5       “ Change of Control ” shall mean, with respect to a Party, any event in which: (a) any Person or group (as such term is defined in the U.S. Securities Exchange Act of 1934, as amended) acquires beneficial ownership of securities of such Party representing more than fifty percent (50%) of the voting power of the then outstanding securities of such Party with respect to the election of directors of such Party; (b ) a Party enters into a merger, consolidation, or similar transaction with any Person in which such Party is not the surviving entity in such transaction; or (c) a Party enters into a transaction to sell to any Person, in one or more related transactions, assets (i) representing all or substantially all of such Party’s assets, (ii) representing all or substantially all of such Party’s assets, or (iii) solely with respect to Medica, all or substantially all of its assets relating to the Products, including without limitation, the Medica IP; provided, however, that with respect to Nephros, no transaction with Lambda Investors LLC or any Affiliate thereof shall constitute a Change of Control.

 

1.6       “ Claim ” shall mean any claim, suit, action, cause of action, proceeding, investigation, dispute, demand, order, directive, obligation, loss, injury, liability, damage, deficiency, assessment, fine, penalty, forfeiture, judgment, lien, diminution of value, notice of violation or non-compliance, cost, and expense, including, without limitation, attorneys’ fees and expenses incurred to enforce this Agreement, cost of defense, and cost of settlement.

 

1.7       “ Commercialization ” means any and all activities directed to marketing, promoting, distributing, offering for sale and selling the Products. When used as a verb, “ Commercialize ” means to engage in Commercialization.

 

1.8       “ Confidential Information ” shall have the meaning ascribed to such term in Section 9.1 .

 

1.9       “ Direct Claim ” shall have the meaning ascribed to such term in Section 10.5 .

 

1.10     “ Disclosing Party ” shall have the meaning ascribed to such term in Section 9.1 .

 

1.11     “ FDA ” shall mean the U.S. Food and Drug Administration.

 

1.12     “ Governmental Authority ” shall mean any national, state, commonwealth, provincial, local or foreign governmental authority, entity, body, branch, agency, department, bureau, board, commission, officer, official, court, adjudicator, tribunal, or other entity, including any Agent, division or subdivision thereof in the Territory exercising executive, legislative, judicial, regulatory or administrative authority over the manufacture, quality, marketing, sale, promotion, storage, handling, testing , labeling, packaging, distribution, supply or disposal of medical device products, including, without limitation, any and all state, commonwealth, provincial, local and foreign equivalents.

 

1.13     “ Indemnitee ” shall have the meaning ascribed to such term in Section 10.3.1 .

 

1.14     “ Indemnitor ” shall have the meaning ascribed to such term in Section 10.3.1 .

 

1.15     “ Installment Payments ” shall have the meaning ascribed to such term in Section 4.1 .

 

1.16     “ Intellectual Property ” means all worldwide patents, copyrights, trademarks, service marks, logos, package designs, trade names, trade secrets, rights in data and all other intellectual property rights (in each case whether registered or unregistered), and including all applications and registrations with respect thereto.

 

1.17     “ Invalidity Claim ” shall have the meaning ascribed to such term in Section 8.4.1.

 

2
 

 

1.18     “ Joint Invention ” means, whether or not protected or protectable, and whether or not Confidential Information, all enhancements, technical modifications, inventions, improvements, technology, data, works, designs, discoveries, tool drawings, manufacturing processes and revisions to the Products that are conceived, reduced to practice, created, written, designed, developed, authored, or made by a Party, its Affiliates or Agents, or any Person on behalf of a Party alone or in combination with others, directly relating to the Products, or derived from a Party’s practice of the Joint Patents .

 

1.19     “ Joint Patents ” means: (a) the Patents Rights recited in Schedule 1 ; (b) the Patent Rights covered by the Joint Inventions; and (c) any and all divisions, continuations, continuations-in-part, patents of addition, reissues, renewals, extensions, registrations, confirmations, re-examinations, supplementary protection certificates or the like of any such Patent Rights and any patents issuing thereon, and foreign equivalents of any of the foregoing in the Territory to the extent such Patent Rights relate to (a) or (b) of this Section 1.19 .

 

1.20     “ Medica IP ” means Intellectual Property owned or controlled by Medica and which is used in or to develop or manufacture the Products, including without limitation, Medica’s, right, title and interest in and to the Joint Patents and the Joint Inventions.

 

1.21     “ Medica Products ” shall mean any Medica filtration products based in whole or in part upon Medica’s proprietary Medisulfone fiber technology and/or other polysulfone based hollow fiber or technology in existence as of the Effective Date or developed at any time during the Term, including, without limitation, those covered under Schedule 2 (the “ Product Schedule ”), but subject to the exclusions set forth in the Product Schedule.

 

1.22     “ Nephros IP ” means Intellectual Property owned or controlled by Nephros and which is used in or to develop or manufacture the Products, including without limitation, Nephros’s, right, title and interest in and to the Joint Patents and the Joint Inventions.

 

1.23     “ Nephros Products ” shall mean any Nephros filtration products based in whole or in part upon Nephros’s proprietary ultrafiltration technology in existence as of the Effective Date or developed at any time during the Term, including, without limitation, those covered under the Product Schedule.

 

1.23     “ Net Sales ” means, for any period of determination, the aggregate amount invoiced by Nephros (or any Affiliate, permitted successor, permitted assignee, or agent of Nephros) to a third party distributor, agent, contractor or end user for the sale of a Products during such period less the following amounts that are actually incurred, allowed and taken or specifically allocated and not already reflected in the amount invoiced: (a) reasonable credits, refunds and allowances for spoiled, damaged, outdated and returned Products, (b) trade volume and cash discounts and rebates (including coupons and government charge-backs) in amounts that are usual and customary to the trade, and (c) sales, use, and other like taxes, excluding income tax. The amounts of any deductions accrued pursuant to clauses (a) – (c) shall be determined from books and records maintained in accordance with U.S. GAAP, consistently applied, and shall only be deducted once and only to the extent not otherwise deducted from the aggregate amount invoiced. “Net Sales” shall not include revenue received by Nephros (or any of its Affiliates) from transactions with an Affiliate, where the Product in question will be resold to an independent third party distributor, agent or end user by the Affiliate where such revenue received by the Affiliate from such resale is included in Net Sales.

 

1.24     “ Patent Rights ” means all existing patents and patent applications and all patent applications hereafter filed, including any continuations, continuations-in-part, divisions, or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing, or as applicable portions thereof or individual claims therein.

 

1.25     “ Permit ” shall mean any application permit, authorization, license, approval, registration, franchise, certificate, permission, exemption, consent, variance, or equivalent decision or document of, from, or required or issued by any Governmental Authority or under any Applicable Law, as amended or supplemented from time to time.

 

3
 

 

1.26     “ Person ” shall mean and include, without limitation: (a) any corporation, partnership, limited liability company, joint venture, joint stock company, association, trust, business trust, estate, unincorporated organization, or other business entity recognized under Applicable Law, other than the Nephros or Medica; (b) any Governmental Authority; or (c) any individual.

 

1.27     “ Plan ” shall have the meaning ascribed to such term in Section 4.9 .

 

1.28     “ Products ” shall mean collectively, the Medica Products and the Nephros Products.

 

1.29     “ Supply Schedule shall have the meaning ascribed to such term in the Recitals.

 

1.30     “ Quarterly Reports ” shall have the meaning ascribed to such term in Section 4.2 .

 

1.31     “ Raw Materials ” shall have the meaning ascribed to such term in Section 5.3 .

 

1.32     “ Receiving Party ” shall have the meaning ascribed to such term in Section 9.1 .

 

1.33     “ Regulatory Authority ” means any national, regional, state, provincial or local regulatory agency, department, bureau, commission, council or other governmental authority in the Territory involved in the granting of approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations for the marketing, sale, manufacturing, testing , labeling, packaging, shipping or supply of medical devices.

 

1.34     “ Royalty Term ” shall have the meaning ascribed to such term in Section 4.2 .

 

1.35     “ Specifications ” means the written specifications for a Product mutually agreed upon by the Parties including as are mutually agreed in writing by the Parties from time to time after the Effective Date and during the Term, which shall become a part of and incorporated by reference in this Agreement.

 

1.36     “ Supply ” means the manufacture, processing, testing, storing, labeling and packaging for and sale and delivery of the Products by Medica for Nephros and its Affiliates and Nephros’s designated sublicensees and distributors.

 

1.37     “ Supply Interruption ” shall have the meaning ascribed to such term in Section 5.3 .

 

1.38     “ Term ” shall have the meaning ascribed to such term in Section 11.1 .

 

1.39     “ Territory ” means worldwide, excluding Italy.

 

1.40     “ Third Party ” means any Person other than Nephros and Medica and their respective Affiliates.

 

1.41     “ Third Party Claim ” shall have the meaning ascribed to such term in Section 10.3.1 .

 

2.           Licenses and Grants .

 

2.1         Commercialization License . Subject to the terms and conditions of this Agreement, Medica hereby grants to Nephros, and Nephros accepts, an exclusive, worldwide license, with right of sublicense, under Medica’s IP to Commercialize the Products in the Territory. Medica covenants and agrees with Nephros that during the Term Medica will not grant any license or similar right with respect to the Products to Commercialize, or to make or have made the Products for sale in the Territory.

 

2.2.         Manufacturing License . Subject to the terms and conditions of this Agreement, Nephros hereby grants to Medica, and Medica accepts an exclusive, worldwide license under the Nephros IP to make and have made the Products during the Term under the terms and conditions set forth in this Agreement. Nephros covenants and agrees with Medica that during the Term Nephros will not grant any license or similar right with respect to the Products to Commercialize, or to make or have made the Products for sale in the Territory.

 

4
 

 

2.3.        Joint Inventions . Each Party hereby grants to the other Party an exclusive (as to Third Parties), royalty-free, license under the Joint Inventions solely in furtherance of the license grants set forth in Section 2.1 and Section 2.2 .

 

2.4.        Trademarks . Subject to the terms and conditions of this Agreement, Medica hereby grants to Nephros, and Nephros accepts, an exclusive, license to use Medica’s “EpoSafe” and “Medisulfone” marks and variations of same in the Territory solely in conjunction with the sale and distribution of the Products.

 

2.4.        Reservation of Rights . Each Party retains all rights in and to its intellectual property not specifically granted to the other Party in Section 2.1 through Section 2.4 .

 

2.5        Expansion of Territory . No earlier than the third anniversary of this Agreement, the Parties may commence discussions concerning whether to include Italy as part of the Territory, which inclusion shall be at the sole option of Nephros. If Nephros elects to include Italy in the Territory, the transfer of that territory to Nephros shall be effected at no cost to Nephros.

 

3.          Other Rights and Obligations of the Parties .

 

3.1        Diligent Efforts . Nephros shall: (a) exercise diligent efforts to promote, market and establish and/or increase the sales of the Medica Products in the Territory to customers in both the private and institutional sectors; (b) schedule periodic discussions, or as Medica may request, between Medica’s representatives and Nephros’s personnel in order to facilitate the dissemination of information about the Medica Products and any promotional and marketing programs related to the Medica Products; (c) inform each of its customers in a timely manner of such programs; and (d) prominently display and actively promote the Medica Products at any tradeshows and other trade meetings which Nephros attends when consistent with the application of the Medica Products. Nephros shall further, employ and maintain at all times, at its cost and expense, professional service representatives in sufficient number for the full promotion, marketing and sale of the Medica Products in the Territory. Any and all such professional service representatives shall be deemed Agents of Nephros and not those of Medica, and Nephros shall train such professional service representatives and direct their activities to ensure that all sales targets are achieved.

 

3.2        Minimum Sales Targets . During the Term Nephros shall comply with the following annual aggregate purchases from Medica.

 

Year   Minimum Purchase by
Nephros from Medica
 
2012   300,000  
2013   500,000  
2014   750,000  

 

For calendar year 2015 and the remaining years of the Term, annual minimum amounts will be mutually negotiated between Medica and Nephros.

 

3.3        Information Sharing . Each Party shall provide the other Party with marketing materials, clinical trial data, other information relating to clinical use of the Products, quality control, approvals, recalls, adverse events and any other information developed or received by the other Party concerning the Products promptly upon such information being developed or becoming available to the other Party and in any event upon the request of Nephros or Medica, as applicable.

 

5
 

 

3.4        Right to Audit . Each Party shall ensure that the other Party’s authorized representatives and, to the extent permitted by Applicable Law, each Governmental Authority having jurisdiction, may examine and inspect, during regular business hours, its facilities or, subject to any reasonable confidentiality restrictions or obligations relating thereto, such Party’s facilities and the facilities of any subcontractor used by it in the performance of this Agreement. This right to inspect may be exercised upon reasonable written notice at any time during the time periods when activities under this Agreement are taking place, or such longer period as shall be required by Applicable Law.

 

4.             Payments and Reports .

 

4.1        Installment Payments . Not in limitation of the royalty set forth in Section 4.3 , as consideration for the license and other rights granted to Nephros under this Agreement, €1,500,000 will be due from Nephros to Medica during the Term in installments as follows:

 

Date   Payment  
Effective Date   500,000  
January 25, 2013   1,000,000  
Total   1,500,000  

 

4.2        Royalties . As further consideration for the license and other rights granted to Nephros under this Agreement, for the period beginning on April 23, 2014 through and including December 31, 2022 (the “ Royalty Term ”), in addition to any payments set forth in this Section 4 , Nephros shall pay to Medica a royalty rate of 3% of Net Sales of Products sold, subject to reduction as set forth in Section 5.6 .

 

4.3        Royalty Reports and Payments . During the Royalty Term, Nephros shall make quarterly royalty payment reports (“ Quarterly Royalty Reports ”) to Medica on or before the sixtieth (60th) day following the end of the preceding calendar quarter. Each Quarterly Royalty Report shall cover the most recently completed calendar quarter and shall show (a) Products sold; (b) the Net Sales with respect to such Products; and (c) the royalties, in Euros, payable with respect to such Net Sales. Each Quarterly Royalty Report shall be accompanied by the payment shown as due on such Quarterly Royalty Report.

 

4.4        Manner of Payment . All sums due under this Agreement shall be payable in Euros by bank wire in immediately available funds to such bank account(s) as Medica shall designate. Nephros shall notify Medica as to the date and amount of any such wire transfer to Medica at least two (2) business days prior to such transfer. All overdue amounts due to Medica hereunder shall bear interest per month at the EURIBOR 360 Day rate + 500 basis points (calculated as a monthly equivalent rate) as published in the Financial Times as of the first business day of the month in which the overdue payment is due .

 

4.5        Taxes and Withholding . Except as set forth in this Section 4.6 , all payments under this Agreement will be made without any deduction or withholding for or on account of any tax, duties, levies, or other charges unless such deduction or withholding is required by Applicable Law or regulations to be assessed against Medica. If Nephros is so required to deduct or withhold, Nephros will: (a) notify Medica of such requirement in writing; (b) pay to the relevant authorities the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against Medica; and (c) forward to Medica an official receipt (or certified copy) or other documentation reasonably acceptable to Medica evidencing such payment to such authorities.

 

4.6        Financial Record Keeping; Audits . Nephros shall keep books and accounts of record in connection with sales of the Products in sufficient detail to permit accurate determination of all figures necessary for verification of royalties to be paid hereunder. Nephros shall maintain such records for a period of at least five (5) years after the end of the calendar quarter in which they were generated; provided, however, that if any records are in dispute and Nephros has received written notice from Medica of the records which are in dispute, Nephros shall keep such records until the later of one (1) year or until such dispute is resolved. Upon reasonable notice to Nephros, Medica shall have the right to examine Nephros’s records to determine the correctness of the amount of royalties paid to Medica under the terms of this Agreement.

 

6
 

 

4.7        Underpayments . If an audit conducted by Medica pursuant to Section 4.7 reveals that additional royalties were due to Medica under this Agreement, Nephros shall pay to Medica the additional royalties within thirty (30) days of the date Nephros receives written notice of such underpayment, together with interest thereon in accordance with Section 4.4 from the date such payment was originally due.

 

4.8        Equity Option Grant . Subject to the terms and conditions hereof. as further consideration for the license and other rights granted to Nephros under this Agreement, pursuant to the Nephros’s 2004 Stock Incentive Plan, as amended (the “ Plan ”), promptly following the execution and delivery of this Agreement, Nephros shall grant Medica options to purchase 300,000 shares of the common stock of Nephros. The exercise price for such options shall be the volume weighted average closing price of Nephros common stock for the ten (10) trading days preceding the Effective Date. Medica’s entitlement to such options shall be subject to: (a) monthly vesting over the initial three years of the Term; (b) approval by the Board; (c) Medica’s execution of a definitive stock option agreement in Nephros’s standard form; and (d) in all instances subject to the terms and conditions of the Plan.

 

5.             Manufacturing and Supply .

 

5.1        Supply . Subject to the terms and conditions hereof and in the Supply Schedule, during the Term, Medica shall exclusively Supply Nephros and Nephros’s Affiliates and their respective sublicensees and distributors with, and Nephros shall exclusively purchase from Medica, all of Nephros’s and its Affiliates’ or their respective sublicensees and distributors’ requirements for the Products in the Territory during the Term, pursuant to purchase orders delivered by Nephros or its Affiliate or Nephros’s Third Party distributor to Medica in accordance with Section 5.5 .

 

5.2        Manufacturing Facility . Medica shall initially produce the Products at the following premises: SarMed s.r.l., Localita Sa Stoia – 09016 Iglesias, Italy. In the event that Medica is no longer able to meet the contractual conditions existing with Nephros on the Effective Date, Nephros will be entitled to cause Medica to qualify and cause a different supplier to manufacture the Products.

 

5.3        Raw Materials . Medica shall have responsibility for the procurement, manufacture, quality control, processing, testing, storage, treatment and handling of all packaging, API and other raw materials, work-in-process and other materials used for Supply (collectively, “ Raw Materials ”). Medica shall Supply the Products in accordance with the terms and conditions of this Agreement and the applicable Product Schedule, Specifications and GMP. Medica shall be solely responsible for disposing of all Raw Materials and wastes arising from its performance hereunder and for performance of its obligations hereunder in accordance with Applicable Law in effect at the time and place of manufacture of the Products.

 

5.4        Quality Control . All quality control processes and procedures relating to the Products shall be the sole cost and responsibility of Medica. Medica shall conduct quality control testing of Products prior to shipment in accordance with the applicable Specifications and Applicable Law. Medica shall prepare and retain records pertaining to such testing as required by Applicable Law and Medica’s standard operating procedures. With every finished lot Medica will provide Nephros with a Certificate of Conformity showing that the products have been manufactured to specifications and pass all QC testing.

 

5.5        Forecasts, Order and Delivery of Products .

 

5.5.1       In order to assist Medica in planning production, Nephros shall deliver to Medica in advance of each calendar quarter a quarterly rolling forecast of the quantities of Products required by Nephros (and/or its Affiliates or their respective sublicensees and distributors), by calendar month, for the following calendar quarter. The quantities of Product set forth in the first month contained in any such quarterly forecast shall be firm and binding on Nephros. The forecasts for the quantities of Products set forth in the remaining months of the forecast period shall be non-binding good faith estimates of Nephros’s Product requirements for such months and shall be used by Medica for production planning. Except as provided in this Section 5.5.1 , forecasts provided by Nephros or its Affiliates or their respective sublicensees and distributors shall be for the sole purpose of assisting Medica in its planning. Medica shall, no later than ten (10) days after receipt of each such forecast, notify Nephros in writing of any objections or prospective problems in meeting Nephros’s forecasted requirements.

 

7
 

 

5.5.2       Nephros shall furnish to Medica binding purchase orders for the quantities of Products which Nephros shall purchase and Medica shall deliver. Such purchase orders shall be delivered by Nephros at least eight (8) weeks in advance of the delivery date specified therein. Medica shall maintain a quantity of safety stock of the Products equal to the monthly average of the preceding quarterly forecast. Medica shall notify Nephros promptly (but in no event in less than ten (10) days after becoming aware) that Medica has less inventory of Product on hand than has been forecasted by Nephros for the next four (4) weeks. Medica shall, within ten (10) days after its receipt of such purchase order, acknowledge such receipt and confirm that Medica can Supply the purchase order. Each such purchase order shall designate the quantity of Product ordered and the date by which Medica must deliver the Product to Nephros or to Nephros’s Affiliates or any Third Party designated by Nephros. No provision of any purchase order submitted by Nephros or its Affiliate or Nephros’s Third Party designated by Nephros or of any confirmation or acknowledgement submitted by Medica shall be controlling to the extent it sets forth any terms or conditions that are additional to, or in conflict or inconsistent with, the terms or conditions of this Agreement or the Supply Schedule.

 

5.5.3       Medica shall deliver the quantities of Product set forth in each purchase order Ex Works Incoterms 2010 edition, published by the International Chamber of Commerce, ICC Publication 560) at Medica’s facility to Nephros’s designated carrier as specified by Nephros in the applicable purchase order. Nephros reserves the right to designate the carrier for shipment from the Medica’s facility provided that Medica has approved such carrier for the facility, such approval not to be unreasonably withheld, conditioned or delayed. Risk of loss and damage to Product shall pass to Nephros when the Product is delivered to Nephros at Nephros’s designated carrier.

 

5.6        Supply Interruption . In the event of a Supply Interruption, other than as a result of an act or omission by Nephros or any of its Affiliates or sublicensees or distributors, which Medica has not cured within thirty (30) days after receipt of written notice from Nephros detailing the Supply Interruption by delivering to Nephros all outstanding purchase orders, not in limitation of any other rights or remedies available to Nephros under this Agreement or otherwise, Nephros shall be entitled to a reduction of the royalty rate payable under Section 4.3 to 1% on the affected Products during the duration of the Supply Interruption and, once cured, for an additional period equivalent to the duration of the Supply Interruption. A “ Supply Interruption ” will be deemed to have occurred and continuing if Nephros has ordered Product from Medica and Nephros documents that during a period of at least two (2) consecutive months Nephros has not received at least eighty percent (80%) of those quantities of Product so ordered. Notwithstanding the foregoing, no Supply Interruption will be deemed to have occurred if the applicable purchase orders referenced above exceed one hundred twenty percent (120%) of the applicable quantities of Product set forth in the forecast delivered by Nephros for the calendar quarter immediately preceding such purchase order. Medica shall be deemed to have cured such Supply Interruption upon delivery to Nephros quantities of Product covered under such outstanding orders but only for that amount which does not exceed one hundred twenty percent (120%) of the applicable quantities of Product set forth in the forecast delivered by Nephros for the calendar quarter immediately preceding such purchase order.

 

5.7        Invoice . Medica shall invoice Nephros for all quantities of Product delivered in accordance herewith. Each invoice shall be delivered concurrently with each shipment of Product. In accordance with Section 4.5 , payment shall be due within forty five (45) days after delivery of the invoice with respect thereto; provided, however, that if Nephros rejects such shipment pursuant to Section 5.9 , then payment shall be due within forty five (45) days after receipt by Nephros of replacement Product.

 

5.8        Price; Price Escalation . The price for Product delivered hereunder, including any applicable discounts relating to samples, shall be as set forth in the Supply Schedule. Prices shall be subject to increase no more than once per annum, based upon documented increases in direct labor and material costs. Any price increase hereunder shall be implemented in the calendar year following the year in which the increase occurred and shall be subject to a three percent (3%) annual increase limit.

 

8
 

 

5.9        Product Not in Compliance with Purchase Order . Within thirty (30) days after receipt of any Product, Nephros or its agent shall perform an examination of the documentation, if any, provided with each shipment of Product, and shall determine whether such Product meets the requirements of the applicable purchase order. In the event that Nephros determines, within such thirty (30) day period, that any Product supplied by Medica does not conform to the applicable purchase order, Nephros shall give Medica written notice thereof and the reason(s) therefor within thirty (30) days after receipt thereof. If Nephros does not submit written notice of rejection within such thirty day period, such Product shall be deemed accepted by Nephros. If a shipment is rejected, Medica shall have the right, and if such right is exercised shall not be deemed in default hereunder to: (a) correct such shipment to conform to the applicable purchase order; or (b) grant Nephros a credit on that portion of the shipment that is nonconforming.

 

5.10      Inspections by Regulatory Authorities . Medica shall allow representatives of any Regulatory Authority to inspect the relevant parts of the facility where the Supply of Product is carried out and to inspect the lot, batch and other manufacturing records to verify compliance with cGMP and ISO 13485 and other Applicable Law and practices and shall promptly notify Medica of the scheduling of any such inspection relating to Supply. Medica shall promptly send to Nephros a copy of any reports, citations, or warning letters received by Medica in connection with an inspection by a Regulatory Authority to the extent such documents relate to or affect Supply.

 

6.             Representations and Warranties .

 

6.1        Representations of Medica . Medica hereby represents and warrants to Nephros that the following statements are and shall be true and correct in all material respects:

 

6.1.1        Organization and Good Standing . Medica: (a) is an entity duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation; (b) has the entity power and authority to conduct the business in which it presently is engaged, to enter into this Agreement, and to perform its obligations hereunder; (c) is qualified to do business in, and is in good standing in, each jurisdiction where the nature of its business in such jurisdiction requires it to be so qualified; and (d) is in good standing with regard to manufacturing quality control with respect to the requirements of the FDA and ISO or other jurisdictions in the Territory which Nephros intends to sell the Products.

 

6.1.2        Authorization and Binding Effect . All corporate action on the part of Medica and its officers and directors necessary for the authorization, execution, and delivery of this Agreement and for the performance of all of Medica’s obligations hereunder has been taken, and this Agreement, when executed and delivered, shall constitute a valid and legally binding obligation of Medica enforceable against Medica in accordance with the terms of this Agreement, except as enforceability may be limited by bankruptcy, insolvency, and other laws affecting creditors’ rights generally or by general equitable principles.

 

6.1.3        Execution, Delivery and Performance . The execution, delivery, and performance by Medica of this Agreement do not: (a) violate or breach the certificate of incorporation, articles of association, bylaws, or other constituent documents of Medica; (b) violate or conflict with any Applicable Law; (c) violate, breach, cause a default under, or otherwise give rise to a right of termination, cancellation, or acceleration with respect to (presently, with the giving of notice or the passage of time), any agreement, contract, or instrument to which Medica is a party or by which any of its assets are bound; or (d) result in creation or imposition of any lien, pledge, mortgage, claim, charge, or encumbrance upon any assets of Medica.

 

6.1.4        Governmental and Other Consents . No consent, authorization, license, Permit, registration or approval of, or exemption or other action by, any Person is required in connection with Medica’s execution and delivery of this Agreement or with the performance by Medica of its obligations hereunder that has not been obtained.

 

6.1.5        No Litigation . To Medica’s knowledge, no Third Party has filed, or threatened in writing to file any claim, lawsuit, charge, complaint or other action alleging infringement of any Medica IP in the Territory.

 

9
 

 

6.1.6        Existence and validity of Medica IP . Any registered Medica IP that is valid and subsisting in the Territory.

 

6.1.7        Inconsistent Obligations . Medica has, as of the Effective Date, no obligation or commitment, and will not, during the Term, assume or undertake any obligation or commitment, that is inconsistent with its obligations under, or the terms and conditions of, this Agreement.

 

6.1.8        Supply of Product . Medica shall ensure its ability to supply Product in accordance with the terms of this Agreement.

 

6.1.9        Specifications and Regulatory Compliance . When supplied, the Products shall be manufactured in accordance with the applicable Specifications, and all other requirements of the FDA and other Applicable Laws and in accordance with cGMP and current E.U. Good Manufacturing Practices.

 

6.1.10      Approvals . Medica has, and during the Term Medica shall maintain, all necessary and appropriate approvals with the FDA and each other applicable Governmental Authority to qualify Medica as a supplier of the Products, and Medica shall: (a) respond fully and accurately to all inquiries directed to it by any Governmental Authority (and Medica shall promptly notify Nephros of same and provide copies of all such written inquiries and Medica’s written responses and submissions relating thereto); (b) assist Nephros in responding to inquiries directed to any of them by any Governmental Authority and relating to the Products; and (c) provide a Governmental Authority with such information and data as is requested by such Governmental Authority with respect to the manufacture of the Products (and Medica shall promptly provide copies thereof to Nephros).

 

6.2        Representations of Nephros . Nephros hereby represents and warrants to Medica that the following statements are and shall be true and correct in all material respects:

 

6.2.1        Organization and Good Standing . Nephros: (a) is a corporation duly organized, validly existing, and in good standing under the laws of Delaware; (b) has the corporate power and authority to conduct the business in which it presently is engaged, to enter into this Agreement, and to perform its obligations hereunder; and (c) is qualified to do business in, and is in good standing in, each jurisdiction where the nature of its business in such jurisdiction requires it to be so qualified.

 

6.2.2        Authorization and Binding Effect . All corporate action on the part of Nephros and its officers and directors necessary for the authorization, execution, and delivery of this Agreement and for the performance of all of Nephros’s obligations hereunder has been taken, and this Agreement, when executed and delivered, shall constitute a valid and legally binding obligation of Nephros enforceable against Nephros in accordance with the terms of this Agreement, except as enforceability may be limited by bankruptcy, insolvency, and other laws affecting creditors’ rights generally or by general equitable principles.

 

6.2.3        Execution, Delivery and Performance . The execution, delivery, and performance by Nephros of this Agreement do not: (a) violate or breach the certificate of incorporation, articles of association, bylaws, or other constituent documents of Nephros; (b) violate or conflict with any Applicable Law; (c) violate, breach, cause a default under, or otherwise give rise to a right of termination, cancellation, or acceleration with respect to (presently, with the giving of notice or the passage of time), any agreement, contract, or instrument to which Nephros is a party or by which any of its assets are bound; or (d) result in creation or imposition of any lien, pledge, mortgage, claim, charge, or encumbrance upon any assets of Nephros.

 

6.2.4        Governmental and Other Consents . No consent, authorization, license, Permit, registration or approval of, or exemption or other action by, any Person is required in connection with Nephros’s execution and delivery of this Agreement or with the performance by Nephros of its obligations hereunder that has not been obtained.

 

10
 

 

6.2.5        Inconsistent Obligations . Nephros has, as of the Effective Date, no obligation or commitment, and will not, during the Term, assume or undertake any obligation or commitment, that is inconsistent with its obligations under, or the terms and conditions of, this Agreement.

 

7.             Right of First Refusal .

 

7.1        Right of First Refusal . If at any time during the term of this Agreement and for one year thereafter, Medica intends to accept an offer from any Person to pursue a Change of Control of Medica Water Division (“ MWD ”), any or all of the Medica Products, the Medisulfone fiber technology or the proprietary process for manufacturing such fiber, or a Change of Control of Medica or any affiliate thereof which would effect a direct or indirect Change of Control of MWD, it shall first notify Nephros of such intent. Nephros shall have a period of one hundred twenty (120) days from the date of receipt of such notice in which to exercise a right of first refusal with respect to such transaction, which shall be by written notice provided to Medica. If Nephros shall exercise such right, then Nephros and Medica shall enter into an agreement in respect of such Change of Control transaction as soon as is reasonably practical, on terms no less favorable to Nephros than the terms proposed to such Person. In the event that Nephros fails to provide a right of first refusal notice within such one hundred twenty (120)-day period, Medica shall be able to enter into such Change of Control transaction with such Person that was the subject of the right of first refusal, provided that the terms of any such arrangement with such Person shall not be any more favorable to such Person than the terms that Medica last offered to Nephros. If Medica fails to close the Change of Control transaction within sixty (60) days after termination of the right of first refusal without exercise, then the rights of Nephros under this Section 7.1 shall be reinstated and applicable to any other proposed Change of Control transactions by Medica.

 

7.2        Assumption of Obligations in Connection with a Change of Control . The Party pursuing a Change of Control transaction shall require the acquirer to expressly assume such Party’s obligations under this Agreement in writing.

 

8.             Patents and Infringement Matters .

 

8.1        Prosecution and Maintenance of Patents .

 

8.1.1       Nephros shall have the right to prepare, file, prosecute, maintain and extend all Patent Rights covering the Joint Patents and related applications. Nephros shall use commercially reasonable efforts to prepare, file, prosecute and maintain, and shall consult with Medica prior to abandoning, any Joint Patents or related applications that are material to and relevant to the matters contemplated in this Agreement. If Nephros fails to undertake (or, after commencement of such filing, prosecution and/or maintenance, ceases) the prosecution or the maintenance of any such Patent Rights, then Medica shall have the right, at its election but not obligation, and Medica shall be entitled, at its sole cost and expense, to file, prosecute and/or maintain such Joint Patent in the Territory in the name of Nephros and shall be entitled to reimbursement for its expenses upon an agreed upon recovery schedule.

 

8.1.2       Each of the Parties shall execute or have executed by its appropriate agents such documents as may be necessary to obtain, perfect or maintain any Patent Rights covering the Joint Patents filed or to be filed pursuant to this Agreement, and shall cooperate with the other Party so far as reasonably necessary with respect to furnishing all information and data in its possession reasonably necessary to obtain or maintain such patent rights.

 

8.1.3       Nephros shall determine, in consultation with Medica, if a Joint Invention warrants patent protection, or whether it should be kept as a trade secret or know-How. If Nephros decides that a patent application should be prepared, filed and prosecuted as a Joint Invention, then the claims, strategy, timing and location of first filing said patent shall be mutually agreed upon by the Parties and costs shared equally or as otherwise agreed by the Parties. If Nephros decides not to go forward with a patent application the Joint Invention will remain know-how available to both Parties subject to Section 9 and neither Party shall publish on or license the know-how without the prior written agreement of the other Party.

 

11
 

 

8.2        Protection of the Joint Patents and Joint Inventions .

 

8.2.1       In case of an infringement of the Joint Patents or Intellectual Property rights covering the Joint Inventions in the Territory by a Third Party, Nephros shall decide whether to act or not in order to protect the Joint Patents or Joint Inventions in its sole discretion. Nephros shall have the sole and exclusive right to select counsel for any suit initiated pursuant to this Section 8.2 .

 

8.2.2       In the event that Nephros determines not to act to protect the Joint Patents or ceases an enforcement action after commencement, Medica may, with prior written authorization by Nephros, act in order to protect the Joint Patents at its sole expense and retain any recovery in connection therewith, subject to reimbursement of any expenses incurred by Nephros in connection with an enforcement action commenced under Section 8.3.1 .

 

8.2.3       If a Party is rewarded financially as a result of successfully enforcing the Joint Patents or Joint Inventions against an infringement, the Parties shall share in any such financial rewards in the same proportion the Parties share royalties are shared in Section 4.2 . If required under Applicable Law in order for the Party to initiate and/or maintain such suit, the other Party shall join as a party to the suit. The other Party shall, in any case, whether required by Applicable Law or not, offer reasonable assistance to the initiating Party in connection therewith.

 

8.3        Patent Invalidity Claims; Claimed Infringement .

 

8.3.1       If a Third Party at any time asserts a claim that any Joint Patents are invalid or otherwise unenforceable (an “ Invalidity Claim ”), control of the response to such claim in the Territory shall, as between the Parties, be determined in the same manner as enforcement rights with respect to such Joint Patents is determined pursuant to Section 8.2 , and the non-controlling Party shall cooperate with the controlling Party in the preparation and formulation of such response, and in taking other steps reasonably necessary to respond, to such Invalidity Claim. Neither Party shall settle or compromise any Invalidity Claim without the consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed. If an Invalidity Claim is asserted with respect to the Joint Patents or any Patent Rights covered by the Joint Inventions, the Parties shall cooperate and shall mutually agree upon an appropriate course of action and shall share equally in the cost and expense of such action.

 

8.3.2       In the event that a Party becomes aware of any claim that the practice by either Party of the Joint Patents, Intellectual Property rights covering Joint Inventions, the Medica IP, or the Nephros IP infringes the Intellectual Property rights of any Third Party, such Party shall promptly notify the other Party. In any such instance, the Parties shall cooperate and shall mutually agree upon an appropriate course of action. Each Party shall provide to the other Party copies of any notices it receives from third parties regarding any patent nullity actions, any declaratory judgment actions and any alleged infringement or misappropriation of Third Party Intellectual Property relating to the Commercialization, manufacture or supply of the Products. Such notices shall be provided promptly, but in no event after more than fifteen (15) days following receipt thereof.

 

12
 

 

9.             Confidentiality .

 

9.1        General . Pursuant to the terms of this Agreement, each of Nephros and Medica (in such capacity, the “ Disclosing Party ”) has disclosed and will be disclosing to the other Party, and to the officers, directors, employees, agents and/or representatives of each (in such capacity, the “ Receiving Party ”) certain secret, confidential or proprietary data, trade secrets, know-how, intellectual property and related information, including, without limitation, operating methods and procedures, marketing, manufacturing, distribution and sales methods and systems, sales figures, pricing policies and price lists and other business information (“Confidential Information”). The Receiving Party shall make no use of any Confidential Information of the Disclosing Party except in the exercise of its rights and the performance of its obligations set forth in this Agreement. The Receiving Party: (a) shall keep and hold as confidential, and shall cause its officers, directors, employees, agents and representatives to keep and hold as confidential, all Confidential Information of the Disclosing Party; and (b) shall not disclose, and shall cause its officers, directors, employees, agents and representatives not to disclose, any Confidential Information of the Disclosing Party. A Disclosing Party’s Confidential Information shall, at all times be and remain the property of the Disclosing Party, its Affiliates and/or licensors, which shall retain the sole and exclusive right, title and/or interest thereto. A Receiving Party shall have no right to use a Disclosing Party’s Confidential Information except as expressly set forth in this Agreement.

 

9.2        Exceptions . The above restrictions on the use and disclosure of Confidential Information shall not apply to any information which: (a) is already known to the Receiving Party at the time of disclosure by the Disclosing Party, as demonstrated by competent proof (other than as a result of prior disclosure under any agreement between the Parties with respect to confidentiality); (b) is or becomes generally available to the public other than through any act or omission of the Receiving Party in breach of this Agreement; (c) is acquired by the Receiving Party from a Third Party who is not directly or indirectly under an obligation of confidentiality to the Disclosing Party with respect to same; or (d) is developed independently by the Receiving Party without use, direct or indirect, of Confidential Information. In addition, nothing in this Section 9 shall be interpreted to limit the ability of either Party to disclose its own Confidential Information to any other Person on such terms and subject to such conditions as it deems advisable or appropriate. Notwithstanding anything in this Agreement to the contrary, during the Term Medica shall keep and hold as confidential the trade secrets and know-how relating to the manufacturing of fiber for the Products without regard to Section 9.2 .

 

13
 

 

9.3        Permitted Disclosures . It shall not be a breach of Section 9.1 if a Receiving Party discloses Confidential Information of a Disclosing Party: (a) pursuant to Applicable Law, including securities laws applicable to a public company, to any Governmental Authority; or (b) in a judicial, administrative or arbitration proceeding to enforce such Party’s rights under this Agreement; provided, that, the Receiving Party (i) provides the Disclosing Party with as much advance written notice as possible of the required disclosure, (ii) reasonably cooperates with the Disclosing Party in any attempt to prevent, limit or seek confidential treatment for the disclosure, and (iii) discloses only the minimum amount of Confidential Information necessary for compliance.

 

9.4        Confidential Terms . Each Party acknowledges and agrees that the terms and conditions of this Agreement shall be considered Confidential Information of each Party and shall be treated accordingly. Notwithstanding the foregoing, each Party acknowledges and agrees that the other may be required to disclose some or all of the information included in this Agreement in order to comply with its obligations under securities laws, and hereby consents to such disclosure to the extent deemed advisable or appropriate by its respective counsel (but only after consulting with the other to the extent practicable). The Parties may also disclose the existence of this Agreement and terms thereof to their directors, investors, officers, employees, attorneys, accountants and other advisers on a need to know basis provided such Persons are under obligations of confidentiality substantially similar to this Section 9 .

 

9.5        Equitable Remedies . Each Party specifically recognizes that any breach by it of this Section 9 may cause irreparable injury to the other Party and that actual damages may be difficult to ascertain, and in any event, may be inadequate. Accordingly (and without limiting the availability of legal or equitable, including injunctive, remedies under any other provisions of this Agreement), each Party agrees that in the event of any such breach, the other Party shall be entitled to seek injunctive relief and such other legal and equitable remedies as may be available.

 

9.6        Return . Upon the expiration or termination of this Agreement, or at any time at Disclosing Party’s request: (a) Receiving Party shall promptly return to Disclosing Party or destroy all materials (in written, electronic or other form) containing or constituting Proprietary Information of Disclosing Party, including any copies and extracts thereof; and (b) Receiving Party shall not use such Confidential Information in any way for any purpose.

 

9.7        Evidence copy . As an exception to Section 9.6 , the Receiving Party will be able to make an electronic or paper copy of the materials returned to the Disclosing Party and deposit it with its lawyer as evidence of the return and future verifications.

 

10.           Indemnification; Limitation of Liability .

 

10.1          Indemnification by Medica . Medica shall, at its cost and expense, indemnify on demand, defend, and forever hold harmless Nephros and its Affiliates from and against any Claim arising out of or resulting from: (a) any breach by Medica or any of its Agents or Affiliates of any obligation, representation, or warranty of Medica under this Agreement; (b) any negligence, error, or omission by Medica or any of its Agents of Affiliates with respect to its or their obligations under or by reason of this Agreement; (c) any violation of Applicable Law that materially adversely impacts Nephros; (d) any fine, penalty, litigation cost, or other assessment of any kind, including, without limitation, those levied by any Governmental Authority; or (e) infringement by the Product resulting from the Improvements of a patent or trademark of any Person, except to the extent that any such Claim shall be within the indemnification obligations of Nephros under Section 10.2 .

 

10.2          Indemnification by Nephros . Nephros shall, at its cost and expense, indemnify on demand, defend, and forever hold harmless Medica and its Affiliates from and against any Claim arising out of or resulting from: (a) any breach by Nephros or any of its Agents of any obligation, representation, or warranty of Nephros under this Agreement; (b) any negligence, error, or omission by Nephros or any of its Agents with respect to its or their obligations under this Agreement; or (c) any violation of Applicable Law that materially adversely impacts Medica, except to the extent that any such Claim shall be within the indemnification obligations of Medica under Section 10.1 .

 

14
 

 

10.3          Procedure for Indemnification .

 

10.3.1        Notice . In the case of a Claim made by Third Party (a “ Third Party Claim ”) as to which a Party (the “ Indemnitor ”) may be obligated to provide indemnification pursuant to this Agreement, such Party seeking indemnification hereunder (“ Indemnitee ”) will notify the Indemnitor in writing of the Third Party Claim (and specifying in reasonable detail the factual basis for the Third Party Claim and to the extent known, the amount of the Third Party Claim) reasonably promptly after becoming aware of such Third Party Claim; provided, however, that failure to give such notification will not affect the indemnification provided hereunder except to the extent the Indemnitor shall have been actually materially prejudiced as a result of such failure.

 

10.3.2        Defense of Claim . If a Third Party Claim is made against an Indemnitee, the Indemnitor will be entitled, within thirty (30) days after receipt of written notice from the Indemnitee of the commencement or assertion of any such Third Party Claim, to assume the defense thereof by providing written notice to Indemnitee of its intention to assume the defense of such Third Party Claims within said thirty (30) day period (at the expense of the Indemnitor) with counsel selected by the Indemnitor and reasonably satisfactory to the Indemnitee for so long as the Indemnitor is conducting a good faith and diligent defense. Should the Indemnitor so elect to assume the defense of a Third Party Claim, the Indemnitor will not be liable to the Indemnitee for any legal or other expenses subsequently incurred by the Indemnitee in connection with the defense thereof; provided, that if under applicable standards of professional conduct a conflict of interest exists between the Indemnitor and the Indemnitee in respect of such claim, such Indemnitee shall have the right to employ separate counsel to represent such Indemnitee with respect to the matters as to which a conflict of interest exists and in that event the reasonable fees and expenses of such separate counsel shall be paid by such Indemnitor; provided, further, that the Indemnitor shall only be responsible for the reasonable fees and expenses of one separate counsel for such Indemnitee. If the Indemnitor assumes the defense of any Third Party Claim, the Indemnitee shall have the right to participate in the defense thereof and to employ counsel, at its own expense, separate from the counsel employed by the Indemnitor. If the Indemnitor assumes the defense of any Third Party Claim, the Indemnitor will promptly supply to the Indemnitee copies of all correspondence and documents relating to or in connection with such Third Party Claim and keep the Indemnitee informed of developments relating to or in connection with such Third Party Claim, as may be reasonably requested by the Indemnitee (including, without limitation, providing to the Indemnitee on reasonable request updates and summaries as to the status thereof). If the Indemnitor chooses to defend a Third Party Claim, all Indemnitees shall reasonably cooperate with the Indemnitor in the defense thereof (such cooperation to be at the expense, including reasonable legal fees and expenses, of the Indemnitor). If the Indemnitor does not elect to assume control by written acknowledgement of the defense of any Third Party Claim within the thirty day period set forth above, or if such good faith and diligent defense is not being or ceases to be conducted by the Indemnitor, the Indemnitee shall have the right, at the expense of the Indemnitor, after three (3) business days’ notice to the Indemnitor of its intent to do so, to undertake the defense of the Third Party Claim for the account of the Indemnitor (with counsel selected by the Indemnitee), and to compromise or settle such Third Party Claim, exercising reasonable business judgment.

 

10.3.3        Settlement of Claims . If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee will agree to a reasonable settlement, compromise or discharge of such Third Party Claim that the Indemnitor may recommend that by its terms obligates the Indemnitor to pay the full amount of Liabilities (whether through settlement or otherwise) in connection with such Third Party Claim and unconditionally and irrevocably releases the Indemnitee completely from all Liabilities in connection with such Third Party Claim; provided, however, that, without the Indemnitee’s prior written consent, the Indemnitor shall not consent to any settlement, compromise or discharge (including, without limitation, the consent to entry of any judgment), and the Indemnitee may refuse to agree to any such settlement, compromise or discharge, that provides for injunctive or other nonmonetary relief affecting the Indemnitee. If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee shall not (unless required by Law) admit any liability with respect to, or settle, compromise or discharge, such Third Party Claim without the Indemnitor’s prior written consent (which consent shall not be unreasonably withheld, delayed or conditioned).

 

15
 

 

10.4          Assumption of Defense . Notwithstanding anything to the contrary contained herein, an Indemnitee shall be entitled to assume the defense of any Third Party Claim with respect to the Indemnitee upon written notice to the Indemnitor pursuant to this Section 10.4 , in which case, the Indemnitor shall be relieved of liability under Section 10.1 or 10.2 , as applicable, solely for such Third Party Claim.

 

10.5          Direct Claims . Any Claim which does not involve a Third Party Claim (a “ Direct Claim ”) shall be asserted by reasonably prompt written notice (stating in reasonable detail, the basis of such claim and a reasonable estimate of the amount thereof) given by the Indemnitee to the Indemnitor. For a period of sixty (60) days from and after the receipt of the written notice the Parties shall attempt in good faith to resolve such Direct Claim. If the parties are unable to resolve such Direct Claim, the party seeking recourse may thereafter institute proceedings under Section 12.13 to enforce said Direct Claim.

 

10.6          Limitation of Liability . EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH A BREACH OR ALLEGED BREACH OF THIS AGREEMENT. THE FOREGOING SENTENCE SHALL NOT APPLY IN CASES OF FRAUD OR BREACHES OF THIS AGREEMENT MADE INTENTIONALLY IN BAD FAITH OR IN RECKLESS DISREGARD FOR THE PROVISIONS OF THIS AGREEMENT AND SHALL NOT LIMIT THE OBLIGATIONS OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY FOR THIRD PARTY CLAIMS UNDER THIS SECTION 10 .

 

11.           Term and Termination .

 

11.1         This Agreement shall commence on the Effective Date and shall continue in effect through December 31, 2022, or until terminated by either Party in accordance with this Agreement.

 

11.2         Either Party shall have the right to terminate this Agreement at any time for a material breach of this Agreement by the other Party, provided that the non-breaching Party shall have first given thirty (30) days prior written notice to the breaching Party describing such material breach and stating the non-breaching Party’s intention to terminate this Agreement if such material breach remains uncured, and the breaching Party thereafter fails to cure such material breach within thirty (30) days thereafter.

 

11.3         This Agreement may be terminated by Medica upon written notice: (a) upon Nephros’s failure to cure a monetary default under this Agreement within thirty (30) days after written notice thereof is provided to Nephros; and (b) in respect of any calendar year commencing April 23, 2014, if aggregate royalties payable to Medica under Section 4.2 fall below €10,000, other than due to a Supply Interruption or otherwise due to the fault of Medica.

 

11.4         This Agreement may be terminated by Nephros upon ninety (90) days’ written notice to Medica for convenience.

 

11.5         If either Party becomes insolvent, makes an assignment for the benefit of its creditors, is placed in the hands of a receiver or liquidates its business, and such action is not cured within thirty (30) days, then, in any such case, the other Party shall have the immediate right, in its sole discretion, to terminate this Agreement by giving written notice to that Party.

 

11.6         No termination hereunder shall constitute a waiver of any rights or causes of action that either Party may have for any acts or omissions or breach hereunder by the other Party prior to the termination date.

 

11.7         The following provisions shall survive the expiration or termination of this Agreement: Section 1 , Section 3.4 , Section 4.7 , Section 5 , Section 7 , Section 8 , Section 9 , Section 10 , this Section 11.7, Section 12 , and provisions relating to accrued payment obligations.

 

16
 

 

12.           Miscellaneous .

 

12.1          Compliance with Laws . At all times during the Term, each Party shall comply in all material respects with Applicable Law in effect in the Territory that is applicable to the Products or the conduct of business under this Agreement.

 

12.2          Independent Contractor . Neither Nephros nor Medica, together in each case with their respective employees or representatives, are under any circumstances to be considered as employees, partners, joint venturers, agents or representatives of the other by virtue of this Agreement, and neither shall have the authority or power to bind the other or contract in the other’s name.

 

12.3          Notices . Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given when so delivered in person, by overnight courier, or by facsimile transmission (with receipt confirmed by automatic transmission report), as follows:

 

If to Nephros:       Nephros, Inc.

41 Grand Ave

River Edge, NJ 07661

Attn: Mr. Paul Mieyal

Facsimile: +1.201.343.5207

 

If to Medica:        Medica S.p.A.

Via Degli Artigiani, 7

41036 Medolla (MO) - ITALY

Attn: Luciano Fecondini

Facsimile: (+39) 0535 52605

 

Either Party may by notice given in accordance with this Section 12.3 to the other Party designate another address or person for receipt of notices hereunder.

 

12.4          Binding Effect; No Assignment; No Third Party Beneficiaries . This Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Neither Nephros nor Medica may assign any of its rights or delegate any of its liabilities or obligations hereunder without the prior written consent of the other whether in connection with a Change of Control or otherwise. Nothing in this Agreement, express or implied, is intended to or shall confer upon any Person other than Medica and Nephros and their respective successors and permitted assigns any right, benefit or remedy of any nature whatsoever under or by reason of this Agreement, except for Affiliates entitled to indemnification pursuant to Section 10 .

 

12.5          No Implied Waivers; Rights Cumulative . No failure on the part of Nephros or Medica to exercise and no delay in exercising any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, including the right or power to terminate this Agreement, shall impair, prejudice or constitute a waiver of any such right, power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as an acquiescence therein, nor shall any single or partial exercise of any such right, power, remedy or privilege preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege.

 

12.6          Severability . If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement shall remain in full force and effect. Any provision of this Agreement held invalid or unenforceable only in part or degree shall remain in full force and effect to the extent not held invalid or unenforceable. The Parties further agree to replace such invalid or unenforceable provision of this Agreement with a valid and enforceable provision that shall achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable provision.

 

17
 

 

12.7          Force Majeure . Neither Party shall be liable for delay in delivery or nonperformance (except for any obligation for the payment of money), in whole or in part, nor shall the other Party have the right to terminate this Agreement except as otherwise specifically provided in this Section 12.7 , where delivery or performance has been affected by a condition beyond a Party’s reasonable control, including fires, floods, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority; provided that the Party affected by such a condition shall, within ten (10) days of its occurrence, give notice to the other Party stating the nature of the condition, its anticipated duration and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is reasonably required and the nonperforming Party shall use its best efforts to remedy its inability to perform; provided, however, that in the event the suspension of performance continues for ninety (90) days after the date of the occurrence, and such failure to perform would constitute a material breach of this Agreement in the absence of such force majeure event, the nonaffected Party may terminate this Agreement immediately by written notice to the other Party.

 

12.8          Section Headings; Construction . The headings of Sections in this Agreement are provided for convenience only and shall not affect its construction or interpretation. All references to “Section” or “Sections” refer to the corresponding Section or Sections of this Agreement. All words used in this Agreement shall be construed to be of such gender or number as the circumstances require. Unless otherwise expressly provided, the word “including” does not limit the preceding words or terms and shall be deemed to be following by the words “without limitation.”

 

12.9          Amendment; Waiver . This Agreement may not be amended except by an instrument signed by each of the Parties hereto. Any Party hereto may: (a) extend the time for the performance of any of the obligations or other acts of another Party hereto; or (b) waive compliance with any of the agreements of another Party or any conditions to its own obligations, in each case only to the extent such obligations, agreements, or conditions are intended for its benefit; provided, however, that any such extension or waiver shall be binding upon a Party only if such extension or waiver is set forth in a writing executed by such Party.

 

12.10          Rules of Construction . The Parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or ruling of construction providing that ambiguities in an agreement or other document shall be construed against the Party drafting such agreement or document.

 

12.11          Publication . Nephros and Medica agree not to issue any press relate or other public statement disclosing the existence of or relating to this Agreement or the Ancillary Agreements without the express written consent of the other Party; provided, however, that neither Party shall be prevented from complying with any duty of disclosure it may have pursuant to Applicable Law, including securities laws applicable to a public company, subject to notifying the other Party in writing and giving such other Party reasonable time to comment on the same prior to disclosure.

 

12.12          Expenses . Except as expressly set forth herein, each Party hereto shall bear all fees and expenses incurred by such Party in connection with, relating to or arising out of the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby, including attorneys’, accountants’ and other professional fees and expenses.

 

12.13          Governing Law/Disputes . This Agreement shall be construed and governed in all respects, and the respective rights of the Parties determined, according to the substantive laws of the State of New York, U.S., without regard to its conflict of laws principles. The application of the United Nations Convention on Contracts for the International Sales of Goods is hereby expressly excluded. Any controversy or claim arising out of or relating to this Agreement or the applicability of this Section 12.13 that is not resolved amicably will be determined by binding arbitration under the Rules of Arbitration of the International Chamber of Commerce. Such arbitration shall be conducted by a sole arbitrator mutually selected by written agreement of the Parties. In the event that the Parties are not able to mutually select the sole arbitrator, the arbitration shall be conducted by a panel of three (3) arbitrators, consisting of one neutral arbitrator to be selected by each of the Parties and a third neutral arbitrator to be selected jointly by the two (2) arbitrators selected by the Parties. Each arbitrator shall be an attorney actively engaged in the practice of law for at least ten (10) years and shall have experience with and knowledge of the medical device industry. The place of the arbitration will be New York, New York. The language of the arbitration shall be English. Prior to commencement of hearings, each of the arbitrators appointed must provide an oath of impartiality. Judgment upon the award rendered by the arbitrators may be entered by any court having jurisdiction thereof. The cost of any such arbitration shall be divided equally by Nephros and Medica, with each Party bearing its own attorneys’ fees and costs. Notwithstanding anything to the contrary contained in this Agreement, either Party shall have the right to bring an action or Claim for interim measures, including specific performance or injunctive relief, in order to preserve its rights or enforce the obligations of the other Party under this Agreement, in any court of competent jurisdiction or having jurisdiction over any of the Parties or their respective assets, without the need to submit such matter to arbitration under this Section 12.13 .

 

18
 

 

12.14          Entire Agreement . This Agreement together with its Exhibits, contains the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements, written or oral, among the Parties thereto.

 

12.15          Counterparts; Facsimile Signatures . This Agreement may be executed in multiple counterparts, all of which, when executed, shall be deemed to be an original and all of which together shall constitute one and the same document. Signatures provided by facsimile transmission shall be deemed to be original signatures.

 

IN WITNESS WHEREOF , the Parties have entered into this Agreement as of the Effective Date.

 

NEPHROS, INC.   MEDICA S.R.L.
     
By: /s/ Gerald J. Kochanski   By: /s/ Luciano Fecondini
  Gerald J. Kochanski     Luciano Fecondini
  Chief Financial Officer     Chief Executive Officer

 

19

 

 

Exhibit 10.2

 

EMPLOYMENT AGREEMENT

 

This EMPLOYMENT AGREEMENT (this “ Agreement ”), made in River Edge, New Jersey as of the 20th day of April 2012 (the “ Effective Date ”), between Nephros, Inc., a Delaware corporation having its executive offices and principal place of business at 41 Grand Avenue, River Edge, New Jersey 07661 (the “ Company ”), and John C. Houghton (“ Executive ”).

 

RECITALS

 

WHEREAS, the Company desires to employ Executive, and Executive desires to accept such employment on the terms and conditions hereinafter set forth:

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth, the Company and Executive agree as follows:

 

1.            Term . The term of this Agreement shall be the period commencing on the Effective Date and ending on April 20, 2016 (the “ Term ”).

 

2.            Employment .

 

2.1            Employment by the Company; Duties . Executive agrees to be employed by the Company during the Term upon the terms and subject to the conditions set forth in this Agreement. Executive shall serve as President and Chief Executive Officer (“ CEO ”), reporting to the Board of Directors of the Company (the “ Board ”), and shall have such duties as may be prescribed by the Board from time to time and which are commonly performed by presidents and chief executive officers of similar sized companies conducting similar business, such as, but not limited to, corporate planning and oversight of the financial functions of the organization.

 

2.2            Performance of Duties . Throughout the Term, Executive shall faithfully and diligently perform Executive’s duties in conformity with the directions of the Board and serve the Company to the best of Executive’s ability. Executive shall devote Executive’s entire working time to the business and affairs of the Company, subject to vacations and sick leave in accordance with Company policy and as otherwise permitted herein and will not engage in any other employment, occupation or consulting for any direct or indirect remuneration, nor engage in any other activities that conflict with his obligations to the Company without the prior written approval of the Board.

 

2.3            Place of Performance . During his employment with the Company, Executive will work at the Company’s offices in River Edge, New Jersey, as necessary or appropriate, or at such other location in the greater New York City area as the Company may determine. Throughout the Term, Executive agrees to maintain Executive’s personal residence within reasonable access to Executive’s place of employment. Executive recognizes that his duties will require, from time to time and at the Company’s expense (subject to Section 3.6 below), travel to domestic and international locations.

 

 
 

 

2 .4            Directorship. Subject to Executive meeting and maintaining the director eligibility requirements of the Board, the Company shall appoint Executive as a director and thereafter include Executive in the management slate for election as a director at each stockholders meeting during the Term at which his term as a director would otherwise expire. The Executive agrees to accept election, and to serve during the Term, as director of the Company, without any compensation therefore other than as specified in this Agreement.

 

3.                Compensation and Benefits .

 

3.1            Base Salary . The Company agrees to pay to Executive a base salary (“ Base Salary ”) at the annual rate of $350,000, payable in equal installments consistent with the Company’s payroll practices.

 

3.2            Performance Bonus . The Company agrees to pay to Executive a target discretionary bonus of 30% of annual Base Salary, as determined by the Company in its sole discretion. The bonus, if any, is subject to: (a) such objectives as may be mutually determined by the Board and Executive from time to time; (b) the Company’s achievement of overall corporate targets approved by the Board; and (c) the terms and conditions of any applicable incentive compensation plan then in effect for senior executives of the Company. The targets with respect to the bonus for the period ending December 31, 2012 (the “ Initial Bonus Period ”) shall be mutually agreed upon between the Executive and the Compensation Committee of the Board of Directors, within sixty (60) days following the Effective Date and such bonus shall be prorated to reflect the Initial Bonus Period. The targets with respect to the bonus for each annual period following the Initial Bonus Period shall be mutually agreed upon at the beginning of each calendar year by the Executive and the Compensation Committee of the Board of Directors. Each bonus, if any, shall be paid to the Executive not later than thirty (30) days after the issuance of the Company’s respective operating financial results and in no event later than March 15 of the calendar year following the calendar year to which the bonus relates.

 

3.3            Grant of Options and Terms Thereof . (a) Upon execution of this Agreement, the Company shall grant to Executive options to purchase 675,000 shares of the Company’s Common Stock (“Options”); and (b) subject to the approval by the stockholders of a commensurate increase in shares authorized for issuance under the Plan, the Company shall grant to Executive 331,550 additional Options no later than December 31, 2012, each such grant pursuant to the Company’s 2004 Stock Incentive Plan or successor plans, if applicable, at the exercise price and subject to the vesting described in Schedule A (with credit for vesting for the subsequently granted Options as if granted on the same date as the initial grant of Options).

 

3.4            Change in Control . In the event of a Change in Control (as defined below), notwithstanding anything to the contrary contained herein, all unvested Options shall vest and become exercisable immediately and, unless all such options are cashed-out in the Change in Control transaction, shall remain exercisable for a period of not less than 360 days (or the expiration of the Option term, if sooner), regardless of whether Executive’s employment is terminated in connection with such Change in Control transaction. For purposes of this Agreement, “ Change in Control ” of the Company shall mean the occurrence of any of the following events (i) any “person,” including a “group,” as such terms are defined in sections 13(d) and 14(d) of the Securities Exchange Act of 1934 Act, as amended, and the rules promulgated thereunder, becomes the beneficial owner, directly or indirectly, whether by purchase or acquisition or agreement to act in concert or otherwise, of more than 50% of the outstanding shares of Common Stock, (ii) the complete liquidation of the Company, (iii) the sale of all or substantially all of the assets of the Company, or (iv) a majority of the members of the Board are elected to the Board without having previously been nominated and approved by a majority of the members of the Board incumbent on the day immediately preceding such election. Notwithstanding the foregoing, a Change in Control shall not be deemed to have occurred as a result of an underwritten public offering of the Company’s Common Stock.

 

2
 

 

3.5            Benefits and Perquisites . Executive shall be entitled to participate in, to the extent Executive is otherwise eligible under the terms thereof, the benefit plans and programs, and receive the benefits and perquisites, generally provided to the Company’s eligible employees, to the extent his age, health and other qualifications make him eligible to participate. Executive shall be entitled to receive four weeks of annual paid vacation in accordance with the Company’s vacation policy, with the timing and duration of specific vacations mutually and reasonably agreed to by the parties hereto.

 

3.6            Travel and Business Expenses . Upon submission of itemized expense statements in the manner specified by the Company, Executive shall be entitled to reimbursement for reasonable travel and other reasonable business expenses duly incurred by Executive in the performance of Executive’s duties under this Agreement in accordance with the policies and procedures established by the Company from time to time for executives of the same level and responsibility as Executive.

 

3.7            No Other Compensation or Benefits; Payment . The compensation and benefits specified in this Section 3 and in Section 4 of this Agreement shall be in lieu of any and all other compensation and benefits. Payment of all compensation and benefits to Executive hereunder shall be made in accordance with the relevant Company policies in effect from time to time to the extent the same are consistently applied, including normal payroll practices, and shall be subject to all applicable employment and withholding taxes and other withholdings.

 

3.8            Cessation of Employment . In the event Executive shall cease to be employed by the Company for any reason, then Executive’s compensation and benefits shall cease on the date of such event, except as otherwise provided herein or in any applicable employee benefit plan or program.

 

4.             Termination of Employment .

 

4.1            Termination . The Company may terminate Executive’s employment for Cause (as defined below), in which case the provisions of Section 4.2 of this Agreement shall apply. The Company may also terminate Executive’s employment in the event of Executive’s Disability (as defined below), in which case the provisions of Section 4.4 of this Agreement shall apply. The Company may also terminate Executive’s employment for any other reason or no reason by written notice to Executive, in which case the provisions of Section 4.5 of this Agreement shall apply. If Executive’s employment is terminated by reason of Executive’s death, retirement or resignation, the provisions of Section 4.3 of this Agreement shall apply. If Executive’s employment terminates for Good Reason (defined below), the provisions of Section 4.5 shall apply.

 

3
 

 

4.2            Termination for Cause . In the event that Executive’s employment hereunder is terminated during the Term by the Company for Cause (as defined below), then the Company shall pay to Executive only the: (a) earned but unpaid Base Salary for services rendered through the date of termination; and (b) any and all unvested Options shall automatically be cancelled and forfeited by Executive as of the date of termination. Employee shall have the right to exercise any and all vested Options within the period commencing on the date of termination and ending ninety days after the date of such termination (or the expiration of the Option term, if sooner), except as otherwise provided in Section 3.4 hereof in the event of a Change in Control (the “ Options Exercise Period ”). Any Options not exercised by Employee within the Options Exercise Period shall be cancelled. In all other respects, all such Options shall be governed by the plans, programs, agreements, and other documents pursuant to which such Options were granted. For purposes of this Agreement, “ Cause ” shall mean (i) an indictment, conviction, or plea of nolo contendere to, any felony or a misdemeanor involving fraud or dishonesty (whether or not involving the Company); (ii) engaging in any act which, in each case, subjects, or if generally known would subject, the Company to public ridicule or embarrassment; (iii) gross neglect or material misconduct in the performance of Executive’s duties hereunder; or (iv) material breach of any provision of this Agreement by Executive; provided, however, that with respect to clauses (iii) or (iv), Executive shall have received written notice from the Company setting forth the alleged act or failure to act constituting “Cause” hereunder and Executive shall not have cured such act or refusal to act within twenty (20) business days of his actual receipt of notice.

 

4.3            Termination by Reason of Death or Retirement or Resignation . In the event that Executive’s employment hereunder is terminated during the Term (x) by reason of Executive’s death, or (y) by reason of Executive’s resignation or retirement (as to which Executive shall give Company at least two (2) weeks notice), then the Company shall pay to Executive only the earned but unpaid Base Salary for services rendered through the date of termination. Any and all unvested Options shall automatically be cancelled and forfeited by Executive as of the date Executive’s resignation or retirement. In the event of Executive's death, any and all unvested Options shall automatically be cancelled and forfeited. Employee or Employee’s estate shall have the right to exercise any and all vested Options within the appropriate options exercise period, which shall be one (1) year after the date of termination in the event of Executive's death or ninety (90) days after the date of termination in the event of Executive's resignation or retirement (or, in each case, the expiration of the Option term, if sooner), except as otherwise provided in Section 3.4 hereof in the event of a Change in Control . Any Options not exercised by Employee within the Options Exercise Period shall be cancelled. In all other respects, all such Options shall be governed by the plans, programs, agreements, and other documents pursuant to which such Options were granted.

 

4
 

 

4.4            Disability . If, as a result of Executive’s incapacity due to physical or mental illness, the Company determines that Executive has failed to perform Executive’s duties hereunder on a full time basis for either: (a) ninety (90) days within any three hundred sixty-five (365) day period; or (b) sixty (60) consecutive days, the Company may terminate Executive’s employment hereunder for “Disability”. In that event, the Company shall pay to Executive the earned but unpaid, Base Salary for services rendered through such date of termination. Any and all unvested Options shall be cancelled as of the date of termination. During any period that Executive fails to perform Executive’s duties hereunder as a result of incapacity due to physical or mental illness (a “ Disability Period ”), Executive shall continue to receive the compensation and benefits provided by Section 3 of this Agreement until Executive’s employment hereunder is terminated; provided, however, that the amount of compensation and benefits received by Executive during the Disability Period shall be reduced by the aggregate amounts, if any, payable to Executive under disability benefit plans and programs of the Company or under the Social Security disability insurance program. Additionally, the vesting of Executive’s Options shall be tolled during the Disability Period and in the event of a termination of this Agreement as a result of Executive’s Disability, any and all unvested Options shall automatically be cancelled and forfeited by Executive as of the date of such termination. Executive (or as applicable, his spouse or estate) shall have the right to exercise any and all vested Options within 1 one (1) year after the date of termination (or the expiration of the Option term, if sooner) . Any Options not exercised by Employee within such period shall be cancelled. In all other respects, all such Options shall be governed by the plans, programs, agreements, and other documents pursuant to which such Options were granted.

 

4.5            Termination by Company for Any Other Reason, including a Change in Control or by Executive for Good Reason . In the event that Executive’s employment hereunder is terminated by the Company prior to the expiration of the Term for any reason other than as provided in Sections 4.2, 4.3 or 4.4 of this Agreement or by Executive for Good Reason any and, all unvested Options shall automatically be cancelled and forfeited by Executive as of the date of such termination (except as provided by Section 3.4 with respect to a Change in Control), vested Options shall remain exercisable for the Options Exercise Period and the Company shall pay to Executive:

 

(a)          any earned but unpaid Base Salary for services rendered through such date of termination; and

 

(b)          continuing payments of severance pay (less applicable withholding taxes) at a rate equal to his Base Salary rate, as then in effect, for a period equal to the Maximum Severance Period (as defined below), (hereinafter the “ Severance Term ”), to be paid periodically in accordance with the Company’s normal payroll policies; provided that if Executive continues to be employed in any capacity by a successor entity following a Change in Control, the severance pay that would otherwise be payable under this Section 4.5 shall be reduced by the amount of base compensation and guaranteed bonus (if any) Executive receives in such capacity during or attributable to the Severance Term. Due to the release requirements set forth in Section 4.6 below, any payment under this Section 4.5(b) scheduled to occur during the first sixty (60) days following the date of termination of employment shall not be paid until the Company's next regular payroll date on or immediately following expiration of the seven (7) day release revocation period required by Section 4.6, and shall include payment of any amount that was otherwise scheduled to be paid prior to the sixtieth (60 th ) day after such termination.

 

5
 

 

Good Reason ” means the occurrence of any of the following events without Executive’s consent, subject to notice and an opportunity to cure: (i) a material reduction in Executive’s Base Salary; (ii) material diminution in Executive’s title, duties, authorities or responsibilities (other than temporarily during a Disability Period or as required by applicable law); (iii) relocation of Executive’s primary work location of more than 35 miles from the Company’s then current work location (unless the relocation would result in a commute by Executive of 35 miles or less as compared to Executive’s then current commute to his then current location); or (iv) the Company’s material breach of this Agreement with respect to the making of any compensation payments to Executive. Executive must provide written notice to the Company of the occurrence of any of the foregoing events or conditions without Executive’s consent within sixty (60) days of the occurrence of such event. The Company or any successor or Affiliate will have a period of twenty (20) business days to cure such event or condition after receipt of written notice of such event from Executive. Any voluntary Termination of Employment for “Good Reason” following such twenty (20) business day cure period must occur no later than the date that is sixty (60) days following the initial occurrence of one of the foregoing events or conditions without Executive’s written consent.

 

As used herein, the “ Maximum Severance Period ” shall mean three months, until Executive has been employed hereunder for at least one year, and, thereafter, shall mean six months.

 

Notwithstanding anything to the contrary contained herein, in the event that Executive shall breach Sections 5, 6 or 7 of this Agreement at any time, in addition to any other remedies the Company may have in the event Executive breaches this Agreement, the Company’s obligation under clause (b) of this Section 4.5 shall cease and Executive’s rights thereto shall terminate and shall be forfeited.

 

4.6            Release . Except for any accrued obligations, the severance payments described in Section 4.5 will be provided to Employee only if the following conditions are satisfied: (a) Executive agrees to continue to be bound by and complies with all surviving provisions of Sections 5, 6 and 7 of this Agreement; and (b) Employee has entered into, within sixty (60) days following the termination date, a full, irrevocable general release, in a form acceptable to the Company and Executive (which form shall be provided by Company to Executive no later than seven (7) days following the termination date), releasing all claims, known or unknown, that Employee may have against the Company, and any subsidiary or related entity, their officers, directors, employees and agents, arising out of or any way related to Employee’s employment or termination of employment with the Company.

 

6
 

 

4.7            Section 409A . Notwithstanding the foregoing, if necessary to comply with the restriction in Section 409A(a)(2)(B) of the Internal Revenue Code of 1986, as amended (the “ Code ”) concerning payments to “specified employees,” any payment on account of Executive’s separation from service that would otherwise be due hereunder within six months after such separation shall nonetheless be delayed until the first business day of the seventh month following Executive’s date of termination and the first such payment shall include the cumulative amount of any payments that would have been paid prior to such date if not for such restriction, together with interest on such cumulative amount during the period of such restriction at a rate, per annum, equal to the applicable federal short-term rate (compounded monthly) in effect under Section 1274(d) of the Code on the date of termination. For purposes of this Agreement, Executive shall be a “specified employee” for the 12-month period beginning on the first day of the fourth month following each “Identification Date” if he is a “key employee” (as defined in Section 416(i) of the Code without regard to Section 416(i)(5) thereof) of the Company at any time during the 12-month period ending on the “Identification Date.” For purposes of the foregoing, the Identification Date shall be December 31.

 

This Agreement is intended to comply with the requirements of Section 409A of the Code and regulations promulgated thereunder (“ Section 409A ”), but the Company does not guarantee such compliance. To the extent that any provision in this Agreement is ambiguous as to its compliance with Section 409A, to the extent possible the provision shall be read in such a manner so that no payments due under this Agreement shall be subject to an "additional tax" as defined in Section 409A(a)(1)(B) of the Code. For purposes of Section 409A, each payment made under this Agreement shall be treated as a separate payment. In no event may Executive, directly or indirectly, designate the calendar year of payment. Notwithstanding anything contained herein to the contrary, in the event any payment on account of Executive’s separation from service constitutes nonqualified deferred compensation subject to (and not exempt from Section 409A), Executive shall not be considered to have terminated employment with the Company for purposes of the right to receive such payment hereof unless he would be considered to have incurred a “termination of employment” from Employer within the meaning of Treasury Regulation §1.409A-1(h)(1)(ii). All reimbursements provided under this Agreement shall be made or provided in accordance with the requirements of Section 409A, including, where applicable, the requirement that (i) any reimbursement is for expenses incurred during Executive’s lifetime (or during a shorter period of time specified in this Agreement), (ii) the amount of expenses eligible for reimbursement during a calendar year may not affect the expenses eligible for reimbursement in any other calendar year, (iii) the reimbursement of an eligible expense will be made on or before the last day of the calendar year following the year in which the expense is incurred, and (iv) the right to reimbursement is not subject to liquidation or exchange for another benefit..

 

7
 

 

5.              Exclusive Employment; Noncompetition .

 

5.1           No Conflict; No Other Employment . During the period of Executive’s employment with the Company, Executive shall not: (a) engage in any activity which conflicts or interferes with or derogates from the performance of Executive’s duties hereunder nor shall Executive engage in any other business activity, whether or not such business activity is pursued for gain or profit, except as approved in advance in writing by the Board; provided, however, that Executive shall be entitled to manage his personal investments and otherwise attend to personal affairs, including charitable activities, in a manner that does not unreasonably interfere with his responsibilities hereunder; or (b) accept any other employment, whether as an executive or consultant or in any other capacity, and whether or not compensated therefor, unless Executive receives the prior written approval of the Board.

 

5.2           No Competition .

 

(a)           Executive acknowledges and recognizes the highly competitive nature of the Company’s business and that access to the Company’s confidential records and proprietary information renders him special and unique within the Company’s industry. In consideration of the payment by the Company to Executive of amounts that may hereafter be paid to Executive pursuant to this Agreement (including, without limitation, pursuant to Sections 3 and 4 hereof) and other obligations undertaken by the Company hereunder, Executive agrees that during (a) his employment with the Company and (b) the period beginning on the date of termination of employment for any reason and ending on the last day of the Severance Term as defined in Section 4.5(b) (the “ Post-Employment Period ”), Executive shall not, directly or indirectly, for himself or any third party, engage without the prior consent of the Company as owner, investor, financier, partner, stockholder, employer, employee, consultant, advisor, director, officer or otherwise in any firm, partnership, corporation, entity, or business that engages or participates in a business that offers any product or service that competes in any material respect with a product or service (i) provided by the Company to customers or (ii) that the Company is developing, during the period of my employment with the Company (a “ Competing Business ”) anywhere in the world where the Company conducts its business, including but not limited to (A) the development of medical equipment in the hemodiafiltration realm for use in ESRD chronic therapy, and (B) the development of cold water or air filtration purification systems.

 

(b)           The provisions of Section 5.2(a) will not be deemed breached merely because Executive owns less than 1% of the outstanding common stock of a publicly-traded company.

 

(c)           The Company shall have the option in its sole and absolute discretion, to extend the restrictions set forth in Section 5.2(a) for an additional six months in return for a six-month extension of the Severance Term and any such extension shall extend the Post-Employment Period accordingly.

 

8
 

 

(d)           The covenants contained in Section 5.2(a) shall be construed as a series of separate covenants, one for each county, city, state, or any similar subdivision in any geographic area. Except for geographic coverage, each such separate covenant shall be deemed identical in terms to the covenant contained in Section 5.2(a). If, in any judicial proceeding, a court refuses to enforce any of such separate covenants (or any part thereof), then such unenforceable covenant (or such part) shall be eliminated from this Agreement to the extent permitted by law and necessary to permit the remaining separate covenants (or portions thereof) to be enforced. In the event that the provisions of this section are deemed to exceed the time, geographic or scope limitations permitted by applicable law, then such provisions shall be, to the extent permitted by law, reformed to the maximum time, geographic or scope limitations, as the case may be, permitted by applicable laws.

 

(e)           Executive acknowledges that the limitations of time, geography and scope of activity agreed to in this no competition provision are reasonable because, among other things, (i) the Company is engaged in a highly competitive industry, (ii) he will have access to trade secrets and know-how of the Company, (iii) he will be able to obtain suitable and satisfactory employment without violation of this agreement, and (iv) these limitations are necessary to protect the trade secrets, confidential information and goodwill of the Company.

 

5.3           Non-Solicitation . In further consideration of the payment by the Company to Executive of amounts that may hereafter be paid to Executive pursuant to this Agreement (including, without limitation, pursuant to Sections 3 and 4 of this Agreement) and other obligations undertaken by the Company hereunder, Executive agrees that during his employment and the Post-Employment Period, he shall not, directly or indirectly: (a) solicit, encourage or attempt to solicit or encourage any of the employees, agents, consultants or representatives of the Company or any of its affiliates to terminate his, her, or its relationship with the Company or such affiliate; (b) solicit, encourage or attempt to solicit or encourage any of the employees of the Company or any of its affiliates to become employees or consultants of any other person or entity; (c) solicit, encourage or attempt to solicit or encourage any of the consultants of the Company or any of its affiliates to become employees or consultants of any other person or entity, provided that the restriction in this clause (c) shall not apply if (i) such solicitation, encouragement or attempt to solicit or encourage is in connection with a business which is not a Competing Business and (ii) the consultant’s rendering of services for the other person or entity will not interfere with the consultant’s rendering of services to the Company; (d) solicit or attempt to solicit any customer, vendor or distributor of the Company or any of its affiliates with respect to any product or service being furnished, made, sold or leased by the Company or such affiliate, provided that the restriction in this clause (d) shall not apply if such solicitation or attempt to solicit is (i) in connection with a business which is not a Competing Business and (ii) does not interfere with, or conflict with, the interests of the Company or any of its affiliates; or (e) persuade or seek to persuade any customer of the Company or any affiliate to cease to do business or to reduce the amount of business which any customer has customarily done or contemplates doing with the Company or such affiliate, whether or not the relationship between the Company or its affiliate and such customer was originally established in whole or in part through Executive’s efforts. For purposes of this Section 5.3 only, the terms “customer,” “vendor” and “distributor” shall mean a customer, vendor or distributor who has done business with the Company or any of its affiliates within twelve months preceding the termination of Executive’s employment.

 

9
 

 

5.4            Notifications . During Executive’s employment with the Company and during the Post-Employment Period, Executive agrees that upon the earlier of Executive’s: (a) negotiating with any Competitor (as defined below) concerning the possible employment of Executive by the Competitor; (b) receiving an offer of employment from a Competitor; or (c) becoming employed by a Competitor, Executive will (i) immediately provide written notice to the Company of such circumstances and (ii) provide copies of Section 5 of this Agreement to the Competitor. Executive further agrees that the Company may provide notice to a Competitor of Executive’s obligations under this Agreement, including without limitation Executive’s obligations pursuant to Section 5 of this Agreement. For purposes of this Agreement, “Competitor” shall mean any entity (other than the Company or any of its affiliates) that engages, directly or indirectly, in any Competing Business.

 

5.5            Sufficient Consideration. Executive understands that the provisions of this Section 5 may limit his ability to earn a livelihood in a business similar to the business of the Company or its affiliates but nevertheless agrees and hereby acknowledges that the consideration provided under this Agreement, including any amounts or benefits provided under Sections 3 and 4 of this Agreement and other obligations undertaken by the Company hereunder, is sufficient to justify the restrictions contained in such provisions. In consideration thereof and in light of Executive’s education, skills and abilities, Executive agrees that he will not assert in any forum that such provisions prevent him from earning a living or otherwise are void or unenforceable or should be held void or unenforceable.

 

6.              Inventions and Proprietary Property .

 

6.1           Definition of Proprietary Property . For purposes of this Agreement, “ Proprietary Property ” shall mean non-public information that relates to the actual or anticipated business or research and development of the Company, designs, specifications, ideas, formulas, discoveries, inventions, improvements, innovations, concepts and other developments, trade secrets, techniques, methods, know-how, technical and non-technical data, works of authorship, computer programs, computer algorithms, computer architecture, mathematical models, drawings, trademarks, copyrights, customer lists and customers (including, but not limited to, customers of the Company on whom Executive called or with whom Executive became acquainted during the term of his employment), marketing plans, and all other matters which are legally protectable or recognized as forms of property, whether or not patentable or reduced to practice or to a writing.

 

6.2           Assignment of Proprietary Property to the Company or its Subsidiaries .

 

(a)           Executive hereby agrees to assign, transfer and set over, and Executive does hereby assign, transfer and set over, to the Company (or, as applicable, a subsidiary or designee of the Company), without further compensation, all of Executive’s rights, title and interest in and to any and all Proprietary Property which Executive, either solely or jointly with others, has conceived, made or suggested or may hereafter conceive, make or suggest, in the course of Executive’s employment with the Company, whether or not patentable or registrable under copyright or similar laws, which Executive may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or developed or reduced to practice, during the period of time Executive is in the employ of the Company.

 

10
 

 

(b)           The assignment of Proprietary Property hereunder includes without limitation all rights of paternity, integrity, disclosure and withdrawal and any other rights that may be known as or referred to as moral rights (“ Moral Rights ”). To the extent that such Moral Rights cannot be assigned under applicable law and to the extent the following is allowed by the laws in the various countries where Moral Rights exist, Executive hereby waives such Moral Rights and consents to any action of the Company or any subsidiary of the Company that would violate such Moral Rights in the absence of such consent. Executive also will endeavor to facilitate such use of any such Moral Rights as the Company, or, as applicable, a subsidiary of the Company, shall reasonably instruct, including confirming any such waivers and consents from time to time as requested by the Company (or, as applicable, a subsidiary of the Company).

 

6.3           Works for Hire . Executive acknowledges that all original works of authorship or other creative works which are made by Executive (solely or jointly with others) within the scope of the employment of Executive by the Company and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101). To the extent such original work of authorship or other creative works are not works made for hire, Executive hereby assigns to the Company (or, as directed by the Company, to a subsidiary of the Company) all of the rights comprised in the copyright of such works.

 

6.4           Disclosure of Proprietary Property and Execution of Documents . Executive further agrees to promptly disclose to the Company any and all Proprietary Property which Executive has assigned, transferred and set over or will assign, transfer and set over as provided in Section 6.2 above, and Executive agrees to execute, acknowledge and deliver to the Company (or, as applicable, to a subsidiary of the Company), without additional compensation and without expense to Executive, any and all instruments reasonably requested, and to do any and all lawful acts which, in the reasonable judgment of the Company or its attorneys (or, as applicable, a subsidiary of the Company or its attorneys) may be required or desirable in order to vest in the Company or such subsidiary all property rights with respect to such Proprietary Property.

 

6.5           Enforcement of Proprietary Rights .

 

(a)           Executive will assist the Company (or, as applicable, a subsidiary of the Company) in every proper way to obtain, assign to the Company (or, as directed by the Company, to a subsidiary), confirm and from time to time enforce, United States and foreign patent trade secret, trademark, copyright, mask work, and other intellectual property rights relating to Proprietary Property in any and all countries. To that end Executive will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company, or, as applicable, a subsidiary of the Company, may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such proprietary rights and the assignment of such Proprietary Property. In addition, Executive will execute, verify and deliver assignments of such Proprietary Property and all rights therein to the Company, its subsidiary or its or their designee. The obligation of Executive to assist the Company, or, as applicable, a subsidiary of the Company, with respect to proprietary rights relating to such Proprietary Property in any and all countries shall continue beyond the termination of employment, but the Company, or as applicable, a subsidiary of the Company, shall compensate Executive at a mutually agreed upon fee, in addition to any expenses, after such termination.

 

11
 

 

(b)           In the event the Company, or, as applicable, a subsidiary of the Company, is unable for any reason, after reasonable effort, to secure the signature of Executive on any document needed in connection with the actions specified in the preceding paragraph, Executive hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as agent and attorney in fact, which appointment is coupled with an interest, to act for and on behalf of Executive, to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by Executive. Executive hereby waives and quitclaims to the Company or, as applicable, a subsidiary of the Company, any and all claims, of any nature whatsoever, which Executive now or may hereafter have for infringement of any proprietary rights assigned hereunder to the Company or such subsidiary.

 

6.6           Third Party Information . To the extent Executive has or possesses any Confidential Information (as hereinafter defined) belonging to Executive or to others, Executive shall not use or disclose to the Company or its subsidiaries or induce the Company or its subsidiaries to use any such Confidential Information unless the Company or its subsidiaries have a legal rights to use such Confidential Information. Executive will promptly advise the Company in writing if any of Executive’s involvement with the Company or any subsidiary of the Company might result in the possible violation of Executive’s undertakings to others or the use of any Confidential Information of Executive or of others.

 

7.              Confidential Information .

 

7.1            Existence of Confidential Information . The Company owns and has developed and compiled, and the Company and its subsidiaries will develop and compile, certain proprietary techniques and confidential information, which have and will have great value to their businesses (referred to in this Agreement, collectively, as “ Confidential Information ”). Confidential Information includes not only information disclosed by the Company (or, as applicable, a subsidiary of the Company) to Executive, but also information developed or learned by Executive during the course or as a result of employment with the Company, which information shall be the property of the Company or, as applicable, such subsidiary. Confidential Information includes all information that has or could have commercial value or other utility in the business in which the Company or any of its subsidiaries is engaged or contemplates engaging, and all information of which the unauthorized disclosure could be detrimental to the interests of the Company or its subsidiary, whether or not such information is specifically labeled as Confidential Information by the Company or such subsidiary. By way of example and without limitation, Confidential Information includes any and all information developed, obtained, licensed by or to or owned by the Company or any of its subsidiaries concerning trade secrets, techniques, know-how (including designs, plans, procedures, merchandising, marketing, distribution and warehousing know-how, processes, and research records), software, computer programs and designs, development tools, all Proprietary Property, and any other intellectual property created, used or sold (through a license or otherwise) by the Company or any of its subsidiaries, electronic data information know-how and processes, innovations, discoveries, improvements, research, development, test results, reports, specifications, data, formats, marketing data and plans, business plans, strategies, forecasts, unpublished financial information, orders, agreements and other forms of documents, price and cost information, merchandising opportunities, expansion plans, budgets, projections, customer, supplier, licensee, licensor and subcontractor identities, characteristics, agreements and operating procedures, and salary, staffing and employment information.

 

12
 

 

7.2            Protection of Confidential Information . Executive acknowledges and agrees that in the performance of Executive’s duties hereunder, the Company or a subsidiary of the Company may disclose to and entrust Executive with Confidential Information which is the exclusive property of the Company or such subsidiary and which Executive may possess or use only in the performance of Executive’s duties to the Company. Executive also acknowledges that Executive is aware that the unauthorized disclosure of Confidential Information, among other things, may be prejudicial to the Company’s or its subsidiaries’ interests, an invasion of privacy and an improper disclosure of trade secrets. Executive shall not, directly or indirectly, use, make available, sell, disclose or otherwise communicate to any corporation, partnership or other entity, individual or other third party, other than in the course of Executive’s assigned duties and for the benefit of the Company, any Confidential Information, either during the Term or thereafter. In the event Executive desires to publish the results of Executive’s work for or experiences with the Company or its subsidiaries through literature, interviews or speeches, Executive will submit requests for such interviews or such literature or speeches to the Board at least fourteen (14) days before any anticipated dissemination of such information for a determination of whether such disclosure is in the best interests of the Company and its subsidiaries, including whether such disclosure may impair trade secret status or constitute an invasion of privacy. Executive agrees not to publish, disclose or otherwise disseminate such information without the prior written approval of the Board.

 

7.3            Delivery of Records . In the event Executive’s employment with the Company ceases for any reason, Executive will not remove from the Company’s premises without its prior written consent any records (written or electronic), files, drawings, documents, equipment, materials and writings received from, created for or belonging to the Company or its subsidiaries, including those which relate to or contain Confidential Information, or any copies thereof. Upon request or when employment with the Company terminates, Executive will immediately deliver the same to the Company.

 

8.              Assignment and Transfer .

 

8.1            Company . This Agreement shall inure to the benefit of and be enforceable by, and may be assigned by the Company to, any purchaser of all or substantially all of the Company’s business or assets, any successor to the Company or any assignee thereof (whether direct or indirect, by purchase, merger, consolidation or otherwise).

 

8.2            Executive . Executive’s rights and obligations under this Agreement shall not be transferable by Executive by assignment or otherwise, and any purported assignment, transfer or delegation thereof shall be void; provided, however, that if Executive shall die, all amounts then payable to Executive hereunder shall be paid in accordance with the terms of this Agreement to Executive’s devisee, legatee or other designee or, if there be no such designee, to Executive’s estate.

 

13
 

 

9.              Miscellaneous .

 

9.1            Other Obligations . Executive represents and warrants that neither Executive’s employment with the Company or Executive’s performance of Executive’s obligations hereunder will conflict with or violate or otherwise are inconsistent with any other obligations, legal or otherwise, which Executive may have. Executive covenants that he shall perform his duties hereunder in a professional manner and not in conflict or violation, or otherwise inconsistent with other obligations legal or otherwise, which Executive may have.

 

9.2            Nondisclosure; Other Employers . Executive represents and warrants that he has not taken or otherwise misappropriated and does not have in his possession or control any confidential and proprietary information belonging to any of his prior employers or connected with or derived from your service to prior employers. Executive represents and warrants that he has returned to all prior employers any and all such confidential and proprietary information. Executive further acknowledges, represents and warrants that the Company has informed Executive that Executive is not to use or cause the use of such confidential or proprietary information in any manner whatsoever in connection with your employment by the Company. Executive agrees, represents and warrants that he will not use such information in connection with his employment by the Company. Executive shall indemnify and hold harmless the Company from any and all claims arising from any breach of the representations and warranties in this Section.

 

9.3            Cooperation . Following termination of employment with the Company for any reason, Executive shall cooperate with the Company, as requested by the Company, to effect a transition of Executive’s responsibilities and to ensure that the Company is aware of all matters being handled by Executive.

 

9.4            Indemnification . The Company shall defend and indemnify the Executive in his capacity as President and CEO of the Company to the fullest extent permitted by applicable law. The Company shall also establish a policy for indemnifying its officers and directors, including but not limited to the Executive, for all actions or omissions permitted under applicable law taken in good faith pursuant of their duties for the Company, including but not limited to the obtaining of an appropriate level of Directors and Officers Liability coverage and including such provisions in the Company’s by-laws or certificate of incorporation, as applicable and customary. The rights to indemnification shall survive any termination of this Agreement.

 

9.5            Protection of Reputation . During the Term and thereafter, Executive agrees that he will take no action which is intended, or would reasonably be expected, to harm the Company or any of its subsidiaries or its or their reputations or which would reasonably be expected to lead to unwanted or unfavorable publicity to the Company or any of its subsidiaries, other than those required in order to permit Executive to comply with applicable law or those made in connection with legal or arbitral process. During the Term and thereafter, the Company agrees that it will take no actions which are intended, or would reasonably be expected, to harm Executive or his reputation or which would reasonably be expected to lead to unwanted or unfavorable publicity to Executive, other than those required in order to permit the Company to comply with applicable law or those made in connection with legal or arbitral process. Notwithstanding the foregoing, this paragraph shall not prevent the Company or Executive from exercising any of their respective rights under this Agreement.

 

14
 

 

9.6           Governing Law . This Agreement shall be governed by and construed (both as to validity and performance) and enforced in accordance with the internal laws of the State of New Jersey applicable to agreements made and to be performed wholly with such jurisdiction, without regard to principles of the conflict of laws thereof or where the parties are located at the time a dispute arises.

 

9.7           Arbitration .

 

(a)           If any dispute arises between Executive and the Company that the parties cannot resolve themselves, including any dispute over the application, validity, construction, or interpretation of this Agreement, arbitration in accordance with the then-applicable employment law rules of the American Arbitration Association shall provide the exclusive remedy for resolving any such dispute, regardless of its nature; provided, however, that the Company may enforce may enforce Executive’s obligation to provide services under this Agreement and Executive’s obligations under Sections 5 through 7 of this Agreement by an action for injunctive relief and damages in a court of competent jurisdiction at any time prior or subsequent to the commencement of an arbitration proceeding as herein provided. This Section 9.6 shall apply to any and all claims arising out of Executive’s employment and its termination, under state and federal statutes, local ordinances, and the common law including, without limitation Title VII of the Civil Rights Act of 1964, as amended, the Civil Rights Act of 1991, the Equal Pay Act, the Employee Retirement Income Security Act, as amended, the Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Family and Medical Leave Act of 1993, the Fair Labor Standards Act, the New Jersey Family Leave Act, the New Jersey Conscientious Employee Protection Act, the New Jersey Civil Rights Act and the New Jersey Law Against Discrimination.

 

(b)           Executive has read and understand this Section 9.7 which discusses arbitration. Executive understands that by signing this Agreement, Executive agrees to submit any claims arising out of, relating to, or in connection with this Agreement, or the interpretation, validity, construction, performance, breach or termination thereof, or Executive’s employment or the termination thereof, to binding arbitration, and that this arbitration provision constitutes a waiver of Executive’s right to a jury trial and relates to the resolution of all disputes relating to all aspects of the employer/employee relationship. Executive further understands that other options such as federal and state administrative remedies and judicial remedies exist and know that by signing this Agreement those remedies are forever precluded and that regardless of the nature of Executive’s complaint, Executive knows that it can only be resolved by arbitration.

 

(c)           Unless the parties agree otherwise, any arbitration shall be administered by and take place in the offices of the American Arbitration Association in Bergen County, New Jersey. If that office is not available, then the arbitrator shall determine the location of the arbitration within New Jersey.

 

15
 

 

9.8            Entire Agreement . This Agreement (including all exhibits hereto) contains the entire agreement and understanding between the parties hereto in respect of Executive’s employment and supersedes, cancels and annuls any prior or contemporaneous written or oral agreements, understandings, commitments and practices between them respecting Executive’s employment, including all prior employment agreements, if any, between the Company and Executive, which agreement(s) hereby are terminated and shall be of no further force or effect.

 

9.9            No Amendment/Waiver . This Agreement may not be amended or modified in any manner nor may any of its provisions be waived except by written amendment executed by the parties. A waiver, modification or amendment by a party shall only be effective if (a) it is in writing and signed by the parties, (b) it specifically refers to this Agreement and (c) it specifically states that the party, as the case may be, is waiving, modifying or amending its rights hereunder. Any such amendment, modification or waiver shall be effective only in the specific instance and for the specific purpose for which it was given.

 

9.10          Severability . If any term, provision, covenant or condition of this Agreement or part thereof, or the application thereof to any person, place or circumstance, shall be held to be invalid, unenforceable or void by a court of competent jurisdiction, the remainder of this Agreement and such term, provision, covenant or condition shall remain in full force and effect, and any such invalid, unenforceable or void term, provision, covenant or condition shall be deemed, without further action on the part of the parties hereto, modified, amended and limited, and the court shall have the power to modify, to the extent necessary to render the same and the remainder of this Agreement valid, enforceable and lawful. In this regard, Executive acknowledges that the provisions of Sections 5, 6 and 7 of this Agreement are reasonable and necessary for the protection of the Company.

 

9.11          Construction . The headings and captions of this Agreement are provided for convenience only and are intended to have no effect in construing or interpreting this Agreement. The language in all parts of this Agreement shall be in all cases construed according to its fair meaning and not strictly for or against the Company or Executive. The use herein of the word “including,” when following any general provision, sentence, clause, statement, term or matter, shall be deemed to mean “including, without limitation.” As used herein, “Company” shall mean the Company and its subsidiaries and any purchaser of, successor to or assignee (whether direct or indirect, by purchase, merger, consolidation or otherwise) of all or substantially all of the Company’s business or assets which is obligated to perform this Agreement by operation of law, agreement or otherwise. As used herein, the words “day” or “days” shall mean a calendar day or days. As used herein, “Compensation Committee” means the Compensation Committee of the Board or, if no such committee is then serving, at least two members of the Board as selected by the Board.

 

16
 

 

9.12          Remedies for Breach . The parties hereto agree that Executive is obligated under this Agreement to render personal services during the Term of a special, unique, unusual, extraordinary and intellectual character, thereby giving this Agreement special value, and, in the event of a breach or threatened breach of any covenant of Executive herein, the injury or imminent injury to the value and the goodwill of the Company’s and its subsidiaries’ businesses could not be reasonably or adequately compensated in damages in an action at law. Accordingly, Executive acknowledges that the Company (and as applicable, one or more of its subsidiaries) shall be entitled to seek injunctive relief or any other equitable remedy against Executive in the event of a breach or threatened breach of Sections 5, 6 or 7 of this Agreement. The rights and remedies of Executive and Company are cumulative and shall not be exclusive, and Executive and Company shall be entitled to pursue all legal and equitable rights and remedies and to secure performance of the obligations and duties of the other under this Agreement, and the enforcement of one or more of such rights and remedies by Executive or Company shall in no way preclude Executive or Company from pursuing, at the same time or subsequently, any and all other rights and remedies available to Executive or Company.

 

9.13          Notices . Any notice, request, consent or approval required or permitted to be given under this Agreement or pursuant to law shall be sufficient if in writing, and if and when sent by certified or registered mail, return receipt requested, with postage prepaid, or by overnight courier, to Executive’s residence, as reflected in the Company’s records with a copy that shall not constitute notice to Julie L. Werner, Esq., Lowenstein Sandler PC, 65 Livingston Avenue, Roseland, NJ 07068, or as otherwise designated by Executive, or to the Company’s principal executive office, attention: Chairman of the Compensation Committee of the Board of Directors with a copy (which shall not constitute notice) to: Michael T. Rave, Attorney at Law, Day Pitney LLP, One Jefferson Road, Parsippany, NJ 07054-2891, as the case may be. All such notices, requests, consents and approvals shall be effective upon being deposited in the United States mail. However, the time period in which a response thereto must be given shall commence to run from the date of receipt on the return receipt of the notice, request, consent or approval by the addressee thereof. Rejection or other refusal to accept, or the inability to deliver because of changed address of which no notice was given as provided herein, shall be deemed to be receipt of the notice, request, consent or approval sent.

 

9.14          Assistance in Proceedings, Etc . Executive shall, without additional compensation during the Term and with complete reimbursement of expenses after the expiration of the Term, upon reasonable notice, furnish such information and proper assistance to the Company as may reasonably be required by the Company in connection with any legal or quasi-legal proceeding, including any external or internal investigation, involving the Company or any of its subsidiaries or in which any of them is, or may become, a party.

 

9.15          Survival . Cessation or termination of Executive’s employment with the Company shall not result in termination of this Agreement. To the extent that any of the obligations of this Agreement constitute continuing obligations, they shall survive any termination or expiration of this Agreement or of Executive’s employment hereunder.

 

[ Signature page follows ]

 

17
 

 

IN WITNESS WHEREOF, each of the parties hereto has duly executed this Agreement as of April 20, 2012, to be deemed effective as of the date first written above.

 

  EMPLOYER
   
  NEPHROS, INC.
   
  By: /s/ Gerald J. Kochanski
  Name: Gerald J. Kochanski
  Title:  Chief Financial Officer
   
  EXECUTIVE
   
  /s/ John C. Houghton
  John C. Houghton

  

18
 

 

SCHEDULE A

 

Options

 

Options: The Options shall vest in equal monthly installments over the Term commencing on the date of initial grant; provided that Executive remains employed by the Company at such time. The Options shall be exercisable at an exercise price equal to the Common Stock’s closing price on the OTC Bulletin Board on the date of grant.

 

19

 

Exhibit 99.1

 

 

PRESS RELEASE

Nephros, Inc.

41 Grand Ave

River Edge, NJ 07661

T: 201. 343. 5202

F: 201. 343. 5207

www.nephros.com

 

Nephros Announces Strategic License and Supply Agreement with Medica S.p.A for Ultrafiltration Products

 

RIVER EDGE, NJ – April 23, 2012 - Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and advanced water purification solutions, today announced that the company has entered into a strategic license and supply agreement with Medica S.p.A. That agreement, which is effective April 23, 2012, grants Nephros exclusive global rights, with specific exceptions, to market products based on Medica’s proprietary Medisulfone ultrafiltration technology.

 

MEDICA S.p.A is located in Medolla, Italy, the largest European center for developing and manufacturing of medical products. MEDICA manufactures and sells a complete range of medical devices in the areas of Chronic and Acute Dialysis, Gastroenterology, Urology, Oncology, Cardiology and microbiological water purification for use in the hospital sector. The Medica Water Division, based in Iglesias, Italy, manufactures a proprietary hollow fiber polysulfone synthetic membrane for blood and water purification in medical and industrial applications. For more information about MEDICA, please visit www.medicasrl.com

 

“Medica and Nephros have a long history of collaboration, and I am pleased to formalize our relationship via today’s agreement which positively addresses the interests of both companies,” said Luciano Fecondini, CEO of Medica.

 

“We are excited to solidify our relationship with Medica through this agreement,” said Dr. Paul Mieyal. “The Medisulfone technology is a differentiated component of ultrafiltration applications. This agreement consolidates the ultrafiltration products and intellectual property of Nephros and Medica into a comprehensive product line and enables Nephros to market these products on an exclusive basis globally.”

 

Summary of Terms

 

Under the terms of the agreement, Medica will provide an exclusive license to Nephros for its ultrafiltration technology on a worldwide basis for the period April 23, 2012 to December 31, 2022. Medica will retain certain product and marketing rights for Italy for the period from April 23, 2012 to April 23, 2015, at which time Nephros will have the option to transition Italy into the global exclusive license for no additional consideration. In exchange for the license, Nephros will pay to Medica €1.5 million in two installments: €500,000 on April 23, 2012 and €1,000,000 on January 25, 2013. As part of the agreement, Nephros has granted to Medica 300,000 options to purchase Nephros common stock which will vest over the first three years of the agreement. For the period April 23, 2014 through December 31, 2022, Nephros will pay to Medica a royalty of 3% of net sales.

 

Nephros Ultrafiltration Products

 

The Association for the Advancement of Medical Instruments’ (AAMI) adoption of more stringent water purity standards for dialysis applications combined with significant observational studies showing a substantial reduction in required erythropoietin dosing when the Nephros DSU is utilized during dialysis therapy has led to significantly increased interest in Nephros ultrafiltration products. In addition to the DSU, Nephros has received FDA 510(k) clearance for its SSU and MSU filters to enable these additional ultrafiltration products to be used in dialysis applications.

 

Nephros has introduced product line extensions for the hospital infection control market which include a more durable filter design to withstand the higher pressures of hospital plumbing, filter covers to improve the aesthetics of the finished installations in hospital showers, and the SafeSpout as an effective, longer lasting, point of use filter to address acute outbreak scenarios. In a study involving two major U.S. hospitals, the Nephros DSU system was shown to be effective in reducing waterborne Legionella bacteria to undetectable levels, an effect which was sustained for the 3-month study period.

 

 
 

 

Nephros has an ongoing collaboration agreement with STERIS Corp. (NYSE: STE) related to its ultrafiltration technology.

 

In response to a Request For Information (RFI) from the U.S. Army, Nephros submitted its UF-40 ultrafilter for consideration as part of the standard issue hydration pack for soldiers in the field. Nephros has been informed by the U.S. Army Public Health Command that its UF-40 filter has been validated to meet the military’s NSF P248 standard for emergency military operations as a microbiological water purifier. Nephros believes that its UF-40 filter is the only stand-alone filter to date to have met the performance criteria of the NSF P248 standard without secondary disinfection steps. The Army has not to date issued a Request For Proposal (RFP), and Nephros has no information regarding when or if an RFP applicable to the UF-40 ultrafilter may be put forth by the U.S. Army.

 

About Nephros, Inc.

 

Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification. The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products, which includes the MSU and SSU ultrafilters. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. The Nephros DSU, MSU, and SSU are FDA cleared for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros’ DSU ultrafilters are being evaluated at several major U.S. medical centers for infection control. Nephros has also developed its UF-40 ultrafilter for purification of drinking water by soldiers in the field.

 

For more information about Nephros, please visit the company’s website at www.nephros.com.

 

Forward-Looking Statements

 

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements include statements regarding the efficacy and intended use of our technologies under development, the timelines for bringing such products to market and the availability of funding sources for continued development of such products and other statements that are not historical facts, including statements which may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that:

 

· we may not be able to continue as a going concern;
· we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations;
· we may not obtain appropriate or necessary regulatory approvals to achieve our business plan or effectively market our products including, without limitation, FDA approval of our HDF system;
· products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials;
· we may encounter problems with our suppliers and manufacturers;
· we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;
· HDF therapy may not be accepted in the United States and/or our technology and products may not be accepted in current or future target markets, which could lead to failure to achieve market penetration of our products;
· we may not be able to sell our ESRD therapy or water filtration products at competitive prices or profitably;
· we may not be able to secure or enforce adequate legal protection, including patent protection, for our products; and
· we may not be able to achieve sales growth in Europe and Canada or expand into other key geographic markets.
 
 

 

More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our other periodic reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

 

 

 

Exhibit 99.2

 

 

PRESS RELEASE

Nephros, Inc.

41 Grand Ave

River Edge, NJ 07661

T: 201. 343. 5202

F: 201. 343. 5207

www.nephros.com

 

Nephros Appoints John C. Houghton as President and Chief Executive Officer

 

RIVER EDGE, NJ – April 23, 2012 - Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today announced that effective April 20, 2012, John C. Houghton has been appointed as President and Chief Executive Officer. In addition, Mr. Houghton is expected to be appointed to the board of directors of Nephros. Effective upon Mr. Houghton’s appointment, Dr. Paul Mieyal stepped down as acting CEO of Nephros and will remain as a member of the board of directors of Nephros.

 

Mr. Houghton has over 25 years of commercialization experience in the pharmaceutical and medical device fields. He has direct experience in building out global commercial organizations including marketing, sales, sales operations, customer service, business analytics and new product development and has also been directly responsible for successfully licensing products and leading joint ventures and partnerships.

 

Mr. Houghton most recently served as President and CEO of CorMedix Inc. (NYSE-Amex: CRMD), a pharmaceutical company focused on therapeutic products for the treatment of cardio-renal disease. While President and CEO, Mr. Houghton led the acquisition of the company’s product candidates and the completion of its initial public offering. Prior to assuming the role of President and CEO, he was the Chief Business Officer for CorMedix. Before joining CorMedix, Mr. Houghton established the global sales and marketing infrastructure for the Biotech division of Stryker Corp. (NYSE: SYK). Prior to Stryker, he worked with Aventis (NYSE: SNY) and predecessor companies for more than 14 years. During his time at Aventis he led the global marketing of Nasacort, served as commercial lead on the Aventis-Millennium inflammation collaboration, and functioned as the global new products commercialization head for respiratory, inflammation, cardiovascular, and metabolism products. Mr. Houghton received his B.Sc. from Liverpool John Moores University, United Kingdom.

 

“After an extensive search process, we look forward to having John in place and driving the company’s growth,” said James S. Scibetta, Chairman of Nephros. “John’s strengths in commercialization and business development are attractive assets which the board feels can add significant value to Nephros.”

 

“I am excited to be joining the Nephros team, and I believe that the company has a very promising future,” said Mr. Houghton. “My immediate goals are to focus on leveraging the just announced agreement with Medica to pursue an aggressive strategy aimed at expansion of Nephros’s ultrafiltration product sales and to continue ongoing communication with the FDA with the intent of obtaining clearance for the company’s hemodiafiltration system. In the intermediate term, Nephros will explore and pursue additional market opportunities for its products and technology while seeking to meet the requirements for relisting of the company’s stock on a national exchange.”

 

DHR International provided executive search services for the recruitment of Mr. Houghton to Nephros.

 

About Nephros, Inc.

 

Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification. The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products, which includes the MSU and SSU ultrafilters. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. The Nephros DSU, MSU, and SSU are FDA cleared for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros’ DSU ultrafilters are being evaluated at several major U.S. medical centers for infection control. Nephros has also developed its UF-40 ultrafilter for purification of drinking water by soldiers in the field.

 

 
 

 

For more information about Nephros, please visit the company’s website at www.nephros.com.

 

Forward-Looking Statements

 

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements include statements regarding the efficacy and intended use of our technologies under development, the timelines for bringing such products to market and the availability of funding sources for continued development of such products and other statements that are not historical facts, including statements which may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that:

 

· we may not be able to continue as a going concern;
· we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations;
· we may not obtain appropriate or necessary regulatory approvals to achieve our business plan or effectively market our products including, without limitation, FDA approval of our HDF system;
· products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials;
· we may encounter problems with our suppliers and manufacturers;
· we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;
· HDF therapy may not be accepted in the United States and/or our technology and products may not be accepted in current or future target markets, which could lead to failure to achieve market penetration of our products;
· we may not be able to sell our ESRD therapy or water filtration products at competitive prices or profitably;
· we may not be able to secure or enforce adequate legal protection, including patent protection, for our products; and
· we may not be able to achieve sales growth in Europe and Canada or expand into other key geographic markets.

 

More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our other periodic reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.