License, Development, Supply & Distribution Agreement

Exhibit 10.44

** Certain information in this exhibit has been omitted and has been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request under Rule 24b-2 of the General Rules and Regulations under the Securities Exchange Act of 1934.

LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT This LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT (this " Agreement" ) is made and entered into as of December 11, 2006 (" Effective Date" ) by and between IMMUNICON CORPORATION, a Delaware corporation, having its principal office at 3401 Masons Mill Road, Suite 100, Huntingdon Valley, PA 19006 and its subsidiaries (collectively, " Immunicon" ), and DIAGNOSTIC HYBRIDS, INC., an Ohio corporation, having its principal office at 350 West State St., Athens, OH 45701 (" DHI" ).

1. BACKGROUND

1.0 Immunicon has expertise and certain proprietary technology relating to cell enrichment, isolation and analysis systems, including fluorescence assay instrumentation, reagents and assays for the isolation and detection and diagnosis of certain disease states of mammalian and other cells or cellular components in tissue, blood or other body fluids, and Immunicon has intellectual property including certain patents and know-how pertaining to such proprietary technology. 1.1 DHI has expertise in the development, marketing, distribution, and sales of products used in the detection of certain pathogens in mammalian cells and for the diagnosis of certain disease states relating thereto, has certain proprietary technology, including reagents, useful in such products, and has experience in regulatory matters relating to such products, and further DHI desires to obtain a license from Immunicon under Immunicon' s aforementioned patents and know-how in order to allow DHI to develop, market, distribute and sell new products, and to sell instrumentation supplied by Immunicon, based upon or utilizing Immunicon' s proprietary technologies.

1.2 Immunicon and DHI desire to collaborate in the development of products in the aforementioned areas utilizing their respective technologies and expertise, with the intent that such new products shall be developed and manufactured, in part by Immunicon and in part by DHI, and marketed and sold for in vitro diagnostic applications exclusively by DHI in the United States and Canada and their respective territories and possessions. In addition, the parties will use their respective best efforts to negotiate commercially reasonable terms and conditions, to be set forth in a separate written agreement, with respect to marketing and sale of such products in all other countries in the manner, and subject to the provisions, of Section 7.2.3 below.


1 2. DEFINITIONS

As used herein, the following terms shall have the respective meanings set forth below:

" Affiliate" of a party means any entity that directly or indirectly controls, is controlled by or is under common control with such party. " Control" (and, with correlative meanings, the terms " controlled by" and " under common control with" ) means, in the case of a corporation, the ownership of fifty percent (50%) or more of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such party or the power to appoint fifty percent (50%) or more of the members of the governing body of the party, or if not meeting the preceding requirement, any company owned or controlled by or owning or controlling a party at the maximum control or ownership right permitted in the country where such party exists.

" Bulk Reagents" means quantities of Capture Reagents supplied by Immunicon to DHI under this Agreement, including all cartridges and other consumable accessories.

" Bulk Reagent Cost" means Immunicon' s fully loaded cost of Bulk Reagents manufactured by Immunicon, determined in accordance with GAAP.

" Calendar Year" means each twelve-month period commencing with January 1 and ending with December 31.

" Capture Reagent" means [************] having a [*******] and other [*******] capable of acting as a [************] for a Target Entity, such [*******] including, but not limited to, [*******], [******], [*****], [*******], or combinations thereof, and provided to DHI by Immunicon under this Agreement.

" Clinical Trial(s)" means human clinical testing as determined by the Management Board meeting regulatory requirements and ethical guidelines as may be specified in individual countries where clinical trials of Products will be conducted or where such trials will be used to seek approval under Regulatory Authority requirements to market, use and sell Products in such country.

" Clinical Trial Plan" means the pre-investigational device exemption (IDE) submitted to the FDA for approval prior to commencing a Clinical Trial for a Product.

" Commercial Period" means the period commencing upon the first date of receipt from the FDA of a pre-marketing clearance or approval for a Product.

" Commercialization Plan" means a plan which includes the identification of target markets, market sizes, sales and marketing strategies and tactics to achieve Forecasts for Products and Instrument Systems under this Agreement. " Confidential Information" means (i) any proprietary or confidential information or other material in a tangible form that is marked as " confidential" at the time it is delivered to the receiving party thereof, or (ii) proprietary or confidential information disclosed orally that is identified as confidential or proprietary when disclosed and such disclosure is confirmed in writing to the receiving party as confidential or proprietary by the disclosing party within thirty (30) days following disclosure.


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" Detection Reagent" means [*******] or [*********] conjugated with [*******], [******], [*********] or other labels capable of providing a detectable response to the presence of a Target Entity captured by a Capture Reagent and detected using an Instrument System. " DHI [******] and [*************]" means all [*******] owned by or licensed [******] which Immunicon [*********] are [**********] in order for it to make [********] for use in accordance with this Agreement, which [*********] will be provided by DHI to Immunicon in accordance with this Agreement.

" FDA" means the United States Food and Drug Administration, or any successor body.

" Field" means the in vitro application of Instrument Systems for the diagnosis or monitoring of Target Entities for the Infectious Diseases identified in Exhibit A in humans solely by detection of [*******] or [*********] and/or [*********] ([*************]) utilizing Products. For the resolution of doubt but not in limitation, the Field shall not include [********], [*******] or [**********] or [********] conditions; applications or analysis involving [********] circulating in blood, [*********], [*********], or [********]; [************], [*******] or [********]; [************], [********] or [******]; [**********] for [*******]; analysis of [****] taken by [*********]; [************], [*******] or [*******]; [***********]; [*********] or [**********] for assessing [**********]; applications involving [************] or other [**************] techniques; or applications involving [*************] techniques. " GAAP" means U.S. generally accepted accounting principles consistently applied. " Infectious Disease" means a disease state characterized by the presence of one or more viruses or bacteria in, on or from the body of a human being.

" Initial Feasibility" means demonstrating proof of principle with respect to the Initial Product(s) in accordance with a feasibility plan approved by the Management Board (" Feasibility Plan" ), using prototype reagents and existing laboratory tools, including but not limited to the Immunicon CellTracksae Analyzer II. It is anticipated that the Management Board, in determining whether Initial Feasibility has been achieved with respect to a Product, will consider such factors as sensitivity, specificity, agreement to predicate device methods, and other key performance characteristics defined as Marketing Essential Characteristics, as indicative of potential success in the relevant marketplace for Products.

" Initial Feasibility Period" means the period prior to Product Development for conducting targeted research and demonstrating Initial Feasibility.

" Instrument System" or " Instrument Systems" means a cell counting device, with non-consumable ancillary accessories and related components and software, that is capable of presenting, characterizing, and counting cells, and providing processed diagnostic information sufficient for detecting the [****************] through the use of [*******]. By way of example but not limitation, an Instrument System contemplated at the Effective Date of this Agreement includes the Immunicon EasyCount99 System together with related components and software, as


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the same may be improved, modified, updated or superceded from time to time. In addition, if Immunicon has another instrument platform in addition to the Easy Count System that may be suitable for use as an Instrument System in the Field utilizing Products, it shall bring the same to the attention of the Management Board, and the Management Board shall determine the suitability of such other platform for use as an Instrument System in the Field utilizing Products. If a decision is taken by the Management Board to undertake a Project Plan for the use of such other platform for such purpose, DHI and Immunicon shall negotiate in good faith commercially reasonable terms and conditions, to be set forth in a separate written agreement, for the sharing of costs associated with such Project Plan. Immunicon at its sole discretion shall determine the suitability of the Immunicon CellTracksae Analyzer II System for use as an Instrument System in the Field utilizing Products, and if a decision is taken to undertake a Project Plan for the use of the CellTracksae Analyzer II System for such purpose, DHI and Immunicon shall negotiate in good faith commercially reasonable terms and conditions, to be set forth in a separate written agreement, for the sharing of costs associated with such Project Plan. The Instrument System does not include Bulk Reagents.

" Instrument System Cost" means Immunicon' s standard cost of manufacturing an Instrument System, as determined in accordance with GAAP.

" Internal End User" means any Affiliate of DHI that is not in the business of reselling Products and whose use of such Products normally results in such Products' consumption. " Inventions" means the Patents and all inventions (patentable or otherwise), developments, designs, applications, improvements, formulae, concepts, ideas, Know-How, methods or processes, discoveries and techniques necessary or desirable for the development, manufacture, sale or distribution of or otherwise relating to Products, Bulk Reagents, Detection Reagents or Instrument Systems, whether owned as of the date hereof or hereafter acquired or licensed.

" In vitro diagnostic" or " IVD" means reagents and/or kits registered for ASR sale, cleared or approved by FDA via 510(K) or PMA process or an equivalent international regulatory process.

" Know-How" means any proprietary information including, without limitation, any trade secret, that is useful in any aspect of the development, use, manufacture or sale of Products or Instrument System and is not publicly known, disclosed or published, including, without limitation, all pre-clinical, clinical, chemical, biochemical, toxicological, analytical, manufacturing, process, formulation and scientific research information, whether or not capable of precise separate description but that alone or when accumulated give to the one acquiring it an ability to study, test, produce, formulate or market Products or Instrument Systems which one otherwise would not have known to study, test, produce, formulate or market in the same way.

" Management Board" means the body comprised of management representatives of Immunicon and DHI as described in Section 3 hereof. The responsibilities of the Management Board are set forth in Section 3.2.

" Marketing Essential Characteristics" means the set of properties, characteristics, and functional requirements that must be incorporated in or displayed by Products and Instrument Systems when combined to make them commercially acceptable in the market in which they are intended to be sold, consistent with the competitive positioning and proposed pricing of the Products and the Instrument Systems.


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" Material Breach" means a failure of a party to perform an express covenant or obligation under this Agreement or a breach of a representation or warranty of a party which failure or breach has had or would reasonably be expected to have a material adverse financial consequence to the non-failing or non-breaching party. " Patents" means (i) all U.S. and foreign patent applications and patents owned or licensed by Immunicon or any of its Affiliates or DHI or any of its Affiliates that have application in the Field; (ii) all U.S. and foreign patent applications and patents owned by Immunicon or DHI, or owned jointly by Immunicon and DHI, that claim inventions that have application in the Field and which are conceived or reduced to practice as part of a Project Plan; and (iii) all divisions, continuations, continuations-in-part, and substitutions thereof; and all extensions, reissues and re-examinations of any of the foregoing; in each case, wherein such patents or applications contain claims that would, but for the respective ownership of, or license to, Immunicon or DHI under clause (i), (ii) or (iii) above or licenses granted under this Agreement, be infringed by Immunicon' s or DHI' s respective activities under this Agreement. A list of the current Patents of Immunicon is attached to this Agreement as Schedule 2.

" Product(s)" means a kit consisting of one or more Detection Reagents, Bulk Reagents, consumable cartridges and other disposable items utilizing an Instrument System for the purpose of magnetic separation or another separation method for capture of Target Entities for the detection of a viral or bacterial microorganism in a Specimen that causes one or more of the Infectious Diseases identified as such in Exhibit A hereto and which performs to the specifications set forth in the Marketing Essential Characteristics therefor as determined by the Management Board, but which in any event shall demonstrate [************] to [************] for such Target Entities commercially available as of the Effective Date if such [***********] exist as of the Effective Date. The term " Initial Products" refers to the Products identified in Exhibit A hereto as Initial Products. " Product Development" means activities conducted as described generally in Section 3 of this Agreement during the period following the Initial Feasibility Period, including advancing prototypes and design, transfer to manufacturing and preparing for commercialization of Initial Products and Instrument Systems for the clinical infectious disease market, under Project Plans as determined by the Management Board. Product Development activities shall include but not be limited to developing specific and sensitive capture and detection antibodies and/or other reagents for Target Entities for the Infectious Diseases identified in Exhibit A hereto, and preparing and submitting Clinical Trial Plans to the FDA for Products that meet the related Marketing Essential Characteristics.

" Project Plan" means the written summary, to be developed jointly by Immunicon and DHI, including the Initial Feasibility, Product Development and Product commercialization activities that are to be conducted by the parties as described in Section 3 of this Agreement, in order to develop and commercialize Products and Instrument Systems under this Agreement. A Project Plan shall be developed for each proposed Product and/or Family of Products hereunder. A Project Plan shall satisfy the process design control elements of DHI' s and Immunicon' s quality management systems. A Project Plan may be modified only in writing by the Management Board.

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" RAP" means a reagent agreement, reagent rental or similar plan or arrangement wherein Products sold by DHI or an Affiliate are increased in price to include an amount to cover the amortized cost of an Instrument System, including maintenance costs, or other equipment (amortized over the useful life thereof) supplied to a customer of DHI or an Affiliate under an agreement with the customer to purchase the Product(s) at such increased price in order that the customer may have the use of such Instrument System and/or other equipment. " Revenue" or " Revenues" means all of the income received by DHI or any of its Affiliates (other than Internal End Users) during a given period from the sale of Products to Third Parties, and income received by DHI from use of Products by Internal End Users, whether or not such income is recognized by DHI as revenue in accordance with standard DHI accounting procedures, less the following amounts: (i) discounts, including cash discounts, or rebates actually allowed or granted, (ii) credits or allowances actually granted upon claims or returns regardless of the party requesting the return, (iii) taxes or other governmental charges levied on or measured by the invoiced amount whether absorbed by the billing or the billed party. In the event that any Product is sold as a combination containing one or more other products, Revenue for such combination will be calculated by multiplying actual Revenue by the fraction A/(A+B) where A is the invoice price of the Product if sold separately, and B is the total invoice price of any other product or products in the combination if sold separately by DHI or any of its Affiliates (or if such other product or products are not sold separately then the standard costs of the Products and such other product or products shall be used); provided, however, that in no event shall such fraction be less than 0.85. In the event that any Products are sold to Third Parties pursuant to a RAP, DHI shall reasonably determine that portion of the amount charged under the RAP that is attributable to Products in accordance with standard DHI accounting procedures reasonably acceptable to Immunicon, and consistent with GAAP. Revenues shall not include income received by DHI or any of its Affiliates from the sale of Specimen Collection devices or the Specimen Transport medium or Revenues received as a commission on the sale of a service or maintenance plan or contract to a customer of an Instrument System.

" Regulatory Authority" means all governmental entities, including but not limited to the US Food and Drug Administration (" FDA" ), regulating the development, manufacture, sale, shipping or distribution of Products or Instrument Systems in any country or groups of countries.

" Regulatory Approval" means any authorization received from a Regulatory Authority to commence commercial marketing, sale and distribution of a Product or Instrument System in any country and any other approvals, clearances, registrations, or permits that may be required to manufacture, market, sell and distribute Products, Instrument Systems, or any related components of such Products or Instrument Systems.

" Research Use Only" or " RUO" as applied to Products or Instrument Systems, means that such Products or Instrument Systems are suitable for use without a Regulatory Approval by an end-user solely for the limited purpose of the end user' s internal research. An ASR-designated reagent shall not be considered a RUO reagent.


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" Specimen" means, but is not limited to, a [*********] such as [*****], [********], [*******], [*****], [********], [******] or [******] which is subjected to analysis for one or more Target Entities using a Product.

" Specimen Collection" and " Specimen Transport" means the collection device and transport medium provided by DHI solely at DHI' s responsibility for processing Specimens prior to analysis by use of Product(s). " Third Party" means any person or entity other than Immunicon, DHI or their respective Affiliates. " Transfer Price" means the price charged to DHI by Immunicon for an Instrument System or Bulk Reagents supplied to DHI under this Agreement.

" Target Entity(ies)" means any aspect or component of a biological sample that upon appropriate analysis with Product(s) and Instrument Systems, would provide diagnostically relevant information in assessing an Infectious Disease condition. A Target Entity may include, without limitation, cells, cell components, an infectious agent, or combinations thereof and specifically includes the Target Entities listed in Exhibit A.

3. PRODUCT DEVELOPMENT

3.1 Project Plans . Immunicon and DHI shall conduct Product Development under Project Plans with the goal of developing Products and Instrument Systems for commercial sale by DHI in accordance with this Agreement. Immunicon and DHI shall each use its reasonable efforts to conduct the activities for which it is responsible with respect to Product Development, in accordance with Project Plans and the provisions of this Agreement, in each case within the time schedule set forth therein and herein. Immunicon and DHI will conduct such activities in a prudent and skillful manner and in accordance in all material respects with the Project Plan then in effect, and further in accordance with all applicable Federal, state and local laws, rules, regulations and other requirements (including, without limitation, Good Laboratory Practices, cGMP, QSR, ISO and the regulations of other non-US Regulatory Authorities).

3.2 Management Board . The Management Board shall provide oversight and advice for the conduct of Product Development as follows:

3.2.1 The Management Board shall be composed of four (4) management representatives of each of Immunicon and DHI, including the Chief Executive Officer of each, and senior sales and marketing, research and development and finance executives. Each party may substitute one or more of its representatives, from time to time in its sole discretion, effective upon notice to the other party of such change. Immunicon shall appoint the chairperson of the Management Board (who shall in any event be the Chief Executive Officer of Immunicon or DHI until after the one year anniversary date of the commencement of the Commercial Period) and so inform DHI, including any changes to the designated chairperson.

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3.2.2 The activities of the Management Board with respect to developing, managing and overseeing execution of the Project Plan(s) from feasibility through commercialization shall include:

(a) Initial Feasibility Period . Provide oversight and guidance during the Initial Feasibility Period, including developing feasibility plans and establishing Marketing Essential Characteristics for Products.

(b) Product Development Period . Provide oversight and guidance during Product Development, including: (i) developing the Project Plan for each Product and the Instrument System, including the Product Development Plan, the Clinical Trial Plan and the Commercialization Plan,

(ii) reviewing and approving activities and progress under each Project Plan and approving any modifications to Project Plans,

(iii) approving all Clinical Trial Plans and any modifications to Clinical Trial Plans. (iv) reviewing progress of all Clinical Trials, and reviewing and evaluating data and conclusions developed from Clinical Trials, (v) reviewing the process for seeking Regulatory Approvals of Products and Instrument Systems, and (vi) reviewing and authorizing submissions for Regulatory Approval.

(c) Commercialization Period .

(i) review and approve Commercialization Plans including Firm Forecasts, and

(ii) consider and adopt any modifications to the Commercialization Plans.

(d) Additional Responsibilities . Carry out such other activities as the parties may from time to time agree. 3.2.3 Unless otherwise agreed, the Management Board shall meet no less frequently than quarterly. Each party shall be responsible for its own costs incurred in connection with such meetings. The site of the meetings shall alternate between a site chosen by Immunicon and a site chosen by DHI.


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3.2.4 The representatives of DHI to the Management Board, voting together, shall have one vote, and the representatives of Immunicon, voting together, shall have one vote. Any approval, determination, decision or other action by the Management Board shall require the approval of the DHI representatives and the Immunicon representatives. Notwithstanding the foregoing and except as otherwise provided in Section 6.8.2(d), in the event the DHI representatives to the Management Board and the Immunicon representatives to the Management Board are unable to reach agreement on a Firm Forecast (as defined in Section 6.8.1), other than the Firm Forecasts for the first and second forecast years, the Immunicon representatives to the Management Board shall cast the deciding vote on such Firm Forecast. 3.2.5 The chairperson of the Management Board or his/her designee shall prepare and deliver to the members of the Management Board within thirty (30) days after the date of a Management Board meeting minutes of such meeting summarizing the matters reviewed and any actions taken and decisions made at such meetings in form and content reasonably acceptable to the parties. 3.3 Project Representative . DHI and Immunicon each shall appoint a person (a " Project Representative" ) to oversee the progress of each Project Plan. The Project Representative of each party shall be the primary contact between the parties for day-to-day collaboration pursuant to this Agreement. Each party shall notify the other within thirty (30) days after the commencement of each Project Plan hereunder of the appointment of its Project Representative and shall notify the other party as soon as practicable upon changing this appointment.

3.4 Development Responsibilities of Immunicon and DHI .

3.4.1 Immunicon shall develop the Instrument System(s) and Bulk Reagents, and DHI shall develop the Detection Reagents and conduct the pre-Clinical Trial and Clinical Trial evaluations of Products, as described more fully in one or more Project Plans. Notwithstanding the foregoing, the parties acknowledge that in order to assure optimization of Bulk Reagents and Detection Reagents and integration thereof into Products, the parties must collaborate in certain of their respective development activities with respect thereto, and accordingly each party hereby agrees to cooperate and collaborate with the other party to provide such scientific, technical and other resources as it in good faith deems to be necessary to assist the other party in its development responsibilities hereunder. Immunicon shall be allowed to utilize its judgment and expertise in such development of Instrument Systems and Bulk Reagents but recognizes that DHI wishes to be informed of all key decisions in advance of their execution and be afforded the opportunity to influence the same. DHI shall be allowed to utilize its judgment and expertise in such development of Detection Reagents but recognizes that Immunicon wishes to be informed of all key decisions in advance of their execution and be afforded the opportunity to influence the same.

3.4.2 DHI, in consultation with Immunicon and as directed by the Management Board, shall conduct evaluations of Bulk Reagents and Detection Reagents for use in Products and evaluate the utilization of same on Instrument Systems, develop Marketing Essential Characteristics and Commercialization Plans, and manage, coordinate, implement and administer Clinical Trials in


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accordance with one or more Project Plans subject to the approval of the Management Board. All Clinical Trials of Products and Instrument Systems shall be conducted in accordance with all applicable legal and regulatory requirements and under the direction of the Management Board. DHI shall not depart in any material manner from the Clinical Trial Plan for a Clinical Trial that is established by the Management Board, without the prior approval of the Management Board.

3.4.3 Immunicon will provide assistance, consultation and advice as appropriate and as determined necessary by the Management Board in connection with Clinical Trials for the filing of submissions with Regulatory Authorities by DHI, and with respect to all other aspects of Regulatory Approval processes. To the extent that the FDA or any other Regulatory Authority requests information with respect to Immunicon in connection with any regulatory filing, Immunicon shall provide such information promptly at no cost to DHI. Immunicon shall use all reasonable efforts to c ...