Joint Research And Development Agreement

EXHIBIT 10.21



[LETTERHEAD OF ITC APPEARS HERE]



Joint Research and Development Agreement



This Agreement (the "Agreement") is made as of Oct 28, 1996 (the "Effective Date") by and between Exigent Diagnostics, Inc. ("Exigent"), a Delaware corporation having its principal place of business at 6100 Bristol Parkway Culver City, Calif, and International Technidyne Corporation ("ITC"), a Delaware corporation having its principal place of business at 8 Olsen Avenue, Edison, NJ





WHEREAS, ITC has certain proprietary know-how, skilled laboratory researchers and manufacturing expertise in the field of plasma coagulation and other diagnostic assays; and



WHEREAS, Exigent has certain proprietary know-how and skilled laboratory researchers in the field of diagnostic assays; and



WHEREAS, ITC and Exigent desire to enter into an agreement for the research, development and evaluation of point-of-care coagulation assay test cartridges and coagulation detector (the research, development and evaluation hereafter referred to as "Research" and the procedures and processes resulting from the Research hereafter referred to as the "Products").



NOW THEREFORE, for and in consideration of the promises and mutual covenants and agreements hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged and accepted, the parties hereto agree as follows:



1. CONTRACT PURPOSE



1.1. The goal of the joint research, development and evaluation effort to be conducted is to develop cost-effective point-of-care plasma coagulation assays, for the benefit of both parties hereto. The principal objectives of the research and development efforts are more particularly set forth in the Coagulation Assays Development Plan attached hereto as Annex I and incorporated herein by this reference. The parties may amend Annex I from time to time by executing a revised, restated, dated Annex I and attaching it hereto.



1.2. The parties agree that ITC and Exigent, through the respective employees of each will perform the tasks specified hereto and in Annex I. The parties agree periodically, but not less frequently than quarterly, commencing on the date three months from the Effective Date of





this Agreement, to review and revise Annex I, as needed.





2. RESEARCH



2.1. The employees of each party hereto, in their respective laboratories, shall perform the tasks specified in Annex I, collaborating at all times in such performance by, without limitation, exchanging materials and information and providing all relevant data, information and results useful to the purposes of this Agreement, to each party hereto, without restriction, other than as specified in this Agreement.



2.2. Exigent will reimburse ITC for each hour of Research work (as per 2.3.) performed by an ITC employee, representative or agent, at the rate of $100 per hour, plus expenses, including, without limitation, the cost of dedicated equipment (inclusive of, without limitation, design, installation and validation costs and exclusive of depreciation costs) and materials and research and development expenses. ITC shall render an invoice each month for such services and expenses and Exigent shall pay such invoice in full within 30 days of receipt thereof. Exigent shall pay ITC interest at the rate of one and one half (1 1/2%) percent per month on any amount not timely paid.



2.3. ITC agrees to responsibility for sections 22, 27, 53 and 68 of Annex I except for subsection 60 of section 53, which is being developed by Battelle Research as part of a contract with Exigent. The estimated budget for ITC based on Annex I work totals $336,000 which includes $48,000 contingency. Approval of use of any portion of the contingency requires the sole approval of Exigent.



2.4. Neither party hereto makes any representation or warranty to the other with respect to the purity, activity, safety, accuracy or usefulness of the materials or information exchanged under this Agreement.



3. PRODUCTS



3.1. Subject to the exclusivity provision of Sections 3.2. and 3.3. below and the patent and other intellectual property provisions set forth in Section 4 below, either party hereto shall have the right to develop, make, use, license and/or sell Products for the equal benefit of both parties hereto. Subject to the exclusivity provisions of Sections 3.2. and 3.3. below and the Royalty provision of section 4.2., any consideration accruing as a result of the development, use, license or sale of Products shall be shared equally by the parties hereto. Any sale or license arrangement or agreement relating to a Product shall be subject to the approval of the party not originating such arrangement or agreement, such approval shall not be unreasonably withheld, delayed or conditioned. This right shall include the right to grant sublicenses with respect to the use or sale of Products to third parties.







3.2. Exigent shall have the exclusive right to, and benefit of, the inventions and discoveries, including Products, resulting from the Research in the field of multitest device point-of-care testing. Multitest devices shall mean those devices capable of performing more than one type of diagnostic assay in a given run. As an example, a device which can test for blood chemistries and coagulation time or combination of chemistry, electrochemistry, coagulation and immunoassay, in which several samples are placed in the same device and the device is instructed to perform the preprogrammed assay without reloading, is a multitest device.



3.3. ITC shall have the exclusive right to, and benefit of, the inventions and discoveries, including Products, resulting from the Research, as it pertains to coagulation in the field of single patient point-of-care testing. Single patient point-of-care testing shall mean cartridge technology with single or multiple coagulation assays or such multiple assays in a single cartridge for a single patient. The Agreement does not restrict ITC from performing coagulation, chemistry, immunoassay or hematology tests, on whole blood or plasma, in cartridges of ITC design provided that if the coagulation cartridge designed as part of this project is used, a royalty will be paid to Exigent as per section 4.2.



3.4. For purposes of this Agreement, point-of-care shall mean a diagnostic test performed in the vicinity of a patient (regardless of species) at the time a sample is obtained from the patient and is expressly contrasted with, and distinguished from, testing performed at a central laboratory within a hospital, or commercial laboratory.



4. PROPRIETARY RIGHTS



4.1. The parties hereto agree promptly to disclose to the other party any and all inventions or discoveries, including Products, made by it in the course of or as a result of the Research, whether discovered or conceived by an employee, agent or representative. The parties hereto acknowledge that the Research and Products will result from the collaboration between the parties and that the right, title and interest in the Research and Products, including the right to domestic and foreign copyright, copyright renewal, trademark and/or patent protection therein and the right to register and claim priority therein under any applicable law, treaty or conventions, shall be equally and jointly owned. Each party hereto will equally share the expenses of prosecuting any patent or otherwise developing or protecting any intellectual property right related to the Research or Products. The processes and strategies of development or protection of intellectual property rights related to the Research and/or Products, including without limitation the scope of protection and/or international activity, shall be the responsibility of both parties equally and each party shall use its best efforts to agree on such processes and strategies.



4.2. Each party hereto shall have, subject to the contrary provisions in Sections 3.2. and 3.3. of this Agreement, the irrevocable right to use all inventions and discoveries (including Products) resulting from the Research. Exigent's rights shall be royalty free. ITC's rights shall be royalty free after ITC has compensated Exigent in cash for 50% of the technology development costs for coagulation assays as contained in this Agreement which payment shall be made prior to ITC's commercialization of inventions and discoveries. Each party hereto shall ensure that the individuals under the control of each shall assign to such party, or to the parties hereto jointly,





all right, title and interest in each invention and/or discovery, such that the parties hereto become the joint owner of any such invention and/or discovery, including all patent or other proprietary rights relating thereto.



4.3. The parties hereto each agree to execute and deliver to the other all reasonable copyright, patent and other applications, assignments and instruments tendered by the other and perform such acts as may be reasonably necessary or advisable for obtaining such rights and/or of vesting and main ...