EX-10.13 COLLABORATION AGREEMENTCollaboration Agreement |
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Exhibit 10.13
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (this “Agreement”) dated as of May 17, 2005 (the “Effective Date”), is entered into between BIOSITE INCORPORATED, a Delaware corporation (“Biosite”), having a place of business at 11030 Roselle Street, San Diego, California 92121, and POWER3 MEDICAL PRODUCTS, INC, a New York corporation (“Power3”), having a place of business at 3400 Research Forest Drive, Suite B2-3, The Woodlands, Texas 77381.
WHEREAS, Biosite owns or has rights in certain expertise, technology and intellectual property rights regarding the development of antibodies.
WHEREAS, Power3 owns or has rights in certain expertise, technology and intellectual property rights regarding certain target biomolecules for antibody development.
WHEREAS, Biosite and Power3 desire to engage in a collaborative research program to attempt to develop antibodies to certain target biomolecules selected by Power3, and to use such antibodies to conduct research to evaluate the diagnostic and therapeutic potential of such target biomolecules, on the terms and subject to the conditions of this Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties hereby agree as follows:
1. DEFINITIONS
For purposes of this Agreement, the terms defined in this Section 1 shall have the respective meanings set forth below:
1.1 “ Affiliate ” shall mean, with respect to any Person, any other Person that directly or indirectly controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other Person, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person by any means whatsoever.
1.2 “ Biosite Improvement ” shall mean any Program Invention that constitutes an improvement or enhancement to (a) the antibody development technology of Biosite or (b) the bodily fluid in vitro diagnostic assay technology of Biosite.
1.3 “ Biosite Inventions ” shall mean all Program Inventions that are solely owned by Biosite.
1.4 “ Biosite Product ” shall mean any product for use in the Exclusive Field, Semi-Exclusive Field or Non-Exclusive Field that assays a Program Target and that if made, used, sold, offered for sale or imported absent the licenses granted hereunder would infringe at least one Valid Claim, or that otherwise uses or incorporates the Power3 Know-How Rights.
1.5 “ Confidential Information ” shall mean, with respect to a party, all information (and all tangible and intangible embodiments thereof) that is disclosed by such party to the other party and is marked, identified as or otherwise acknowledged to be confidential at the time of disclosure to the other party. Notwithstanding the foregoing, Confidential Information of a party shall not include information that the other party can establish by written documentation (a) to have been publicly known prior to disclosure of such information by the disclosing party to the receiving party; (b) to have become publicly known, without the fault of the receiving party, subsequent to disclosure of such information by the disclosing party to the receiving party; (c) to have been received by the receiving party at any time from a source, other than the disclosing party, rightfully having possession of and the right to disclose such information; (d) to have been otherwise known by the receiving party prior to disclosure of such information by the disclosing party to the receiving party; or (e) to have been independently developed by employees or agents on behalf of the receiving party without access to or use of such information disclosed by the disclosing party to the receiving party (each, a “Confidentiality Exception”).
1.6 “ Exclusive Field ” shall mean the in vitro detection or measurement of one or more analytes, by means of a diagnostic device(s), instrument(s) or combination thereof, with a stated average throughput equal to or less than one hundred (100) patient samples per hour, for use in the detection, prognosis, diagnosis or monitoring of any breast cancer-related disease, state or condition in humans or animals.
1.7 “ First Commercial Sale ” shall mean, with respect to any Biosite Product and any country, the first bona fide transaction for which consideration is received for the sale, use, lease, transfer or similar disposition of such Biosite Product by a party, its Affiliate or (sub)licensee to customers who are not Affiliates in such country after all applicable marketing and pricing approvals (if any) have been granted by the applicable governing health authority of such country.
1.8 “ Issued Royalty Term ” shall mean, with respect to each Biosite Product in each country of sale, the term for which at least one (1) Valid Claim defined in Section 1.28(a) remains in effect and would be infringed, but for the license granted by this Agreement, by the use, offer for sale, sale or import of such Biosite Product in such country.
1.9 “ Joint Inventions ” shall mean all Program Inventions that are jointly owned by Biosite and Power3.
1.10 “ Monoclonal Preparation ” shall mean a preparation containing a Fab or Fab fragment with a specific affinity to a Program Target.
1.11 “ Net Sales ” shall mean, with respect to any Biosite Product, the gross sales price of such Biosite Product invoiced by Biosite, its Affiliate, or its (sub)licensee to customers who are not Affiliates (or are Affiliates but are the end users of such Biosite Product) less, to the extent actually paid or accrued by Biosite or its Affiliate (as applicable), (a) credits, allowances, discounts and rebates to, and chargebacks from the account of, such customers for spoiled, damaged, out-dated and returned Biosite Product; (b) freight and insurance costs incurred by Biosite or its Affiliate (as applicable) in transporting such Biosite Product in final form to such customers; (c) cash, quantity and trade discounts, rebates and other price reductions for such
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Biosite Product given to such customers under price reduction programs that are consistent with industry practices and price reductions given for similar products by Biosite or its Affiliate (as applicable); (d) sales, use, value-added and other direct taxes incurred on the sale of such Biosite Product in final form to such customers; and (e) customs duties, surcharges and other governmental charges incurred in exporting or importing such Biosite Product in final form to such customers. Notwithstanding anything to the contrary in this Agreement, if any reusable instrument (that is itself a Biosite Product) is used in combination with a separate diagnostic reagent-containing device (that is itself a Biosite Product) to detect or measure one or more analytes from a patient sample on or in such device, then for purposes of calculating Net Sales, such device shall constitute a Biosite Product, but such instrument shall not constitute a Biosite Product.
1.12 “ Net Sublicensing Revenues ” shall mean, with respect to any Biosite Product, the aggregate cash consideration received by Biosite or its Affiliates in consideration for the sublicense under the Power3 Patent Rights or Power3 Know-How Rights by Biosite or its Affiliates to a Third Party sublicensee with respect to such Biosite Product (excluding (i) royalties received by Biosite or its Affiliates based on Net Sales of such Biosite Product by such sublicensee, and (ii) amounts received to reimburse Biosite or its Affiliates’ cost to perform research, development or similar services conducted for such Biosite Product after signing the agreement with the Third Party, in reimbursement of patent or other out-of-pocket expenses on such Biosite Product, or in consideration for the purchase of any securities of Biosite or its Affiliates at a price up to one hundred percent (100%) of the then fair market value of such securities).
1.13 “ Non-Exclusive Field ” shall mean the in vitro detection or measurement of one or more analytes, by means of a diagnostic device(s), instrument(s) or combination thereof, for use in the detection, diagnosis and monitoring of any neurological-related disease, state or condition in humans and animals.
1.14 “ Omniclonal Preparation ” shall mean a mixture containing a variety of Fab or Fab fragments with varying affinity to a Program Target.
1.15 “ Pending Royalty Term ” shall mean, with respect to each Biosite Product in each country of sale that is not covered by at least one (1) Valid Claim as defined in Section 1.28(a), the term during which at least one (1) Valid Claim defined in Section 1.28(b) that has not been abandoned or finally disallowed without the possibility of appeal or refiling remains in effect and would be infringed (if in an issued patent), but for the license granted by this Agreement, by the use, offer for sale, sale or import of such Biosite Product in such country.
1.16 “ Person ” shall mean an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.
1.17 “ Power3 Inventions ” shall mean all Program Inventions that are solely owned by Power3.
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1.18 “ Power3 Know-How Rights ” shall mean all trade secret and other know how rights in all inventions, discoveries, compositions, technology, data and information of any type whatsoever, (a) that relates to a Program Antibody, Program Target or fragment thereof (or any nucleotide sequence that encodes, or amino acid sequences of the foregoing); (b) that are reasonably necessary or useful for Biosite to conduct its obligations or exercise its rights under this Agreement; (c) that are either (i) disclosed by Power3 to Biosite and do not fall within the scope of a Confidentiality Exception, or (ii) developed or generated by Power3 in the course of conducting its obligations under the Program; and (d) in which Power3 has an ownership or other licensable interest during the term of the Agreement.
1.19 “ Power3 Patent Rights ” shall mean (a) all patent applications heretofore or hereafter filed or having legal force in any country that claim (i) a Program Antibody, Program Target or fragment thereof (or any nucleotide sequence that encodes, or amino acid sequences of the foregoing), or (ii) any process of manufacture or use of a Program Antibody, Program Target or fragment thereof (or any nucleotide sequence that encodes, or amino acid sequences of the foregoing) made or conceived prior to the Effective Date or in the performance of the Program; (b) all patents that have issued or in the future issue therefrom, including without limitation utility, model and design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, reexaminations, renewals, extensions or additions to any such patent applications and patents; in each case in which Power3 has an ownership or other licensable interest during the term of the Agreement.
1.20 “ Program ” shall mean the collaborative research program to develop antibodies directed to certain target biomolecules from selected by Power3, and to use such antibodies to evaluate the diagnostic and therapeutic potential of such target biomolecules, described in Section 3 below.
1.21 “ Program Antibody ” shall mean, with respect to each Program Target provided by Power3 under Section 3.1.1(d), (a) any Omniclonal Preparation to such Program Target (or any fragment thereof) that is developed by Biosite and delivered to Power3 pursuant to this Agreement; (b) any Monoclonal Preparation to such Program Target (or any fragment thereof) that is developed by Biosite and delivered to Power3 pursuant to this Agreement; and (c) any antibody to such Program Target (or any fragment thereof) derived in whole or in part from the preparations described in clauses (a) and (b) above, or the nucleotide sequences encoding or the amino acid sequences of the preparations described in clauses (a) and (b) above.
1.22 “ Program Invention ” shall mean any invention, discovery, composition, enhancement, technology, data or information (whether or not patentable) made or conceived by employees or others on behalf of Biosite, Power3 or both in the performance of the Program during the term of the Program.
1.23 “ Program Target ” shall mean a target biomolecule that is selected by Power3 pursuant to Section 3.1.1(a), designated by the parties pursuant to Section 3.1.1(b), and for which the parties reach agreement regarding the mutually acceptable specificity, affinity and other specifications (if any) desired for the antibody thereto pursuant to Section 3.1.1(c), together with (a) any derivatives, parts or polymorphisms (including without limitation splice variants) of such target biomolecule, (b) any nucleotide sequences with homology to such target biomolecule
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(together with any derivatives, parts or splice variants of such nucleotide sequences) and (c) amino acid sequences and proteins encoded by each such nucleotide sequences (together with any derivatives or parts of such amino acid sequences and proteins).
1.24 “ Samples ” shall have the meaning set forth in Section 3.1.5(a) below.
1.25 “ Semi-Exclusive Field ” shall mean, collectively, (a) research use for any diagnostic purpose, and (b) the in vitro detection or measurement of one or more analytes, by means of a diagnostic device(s), instrument(s) or combination thereof, with a stated average throughput greater than one hundred (100) patient samples per hour, for use in the detection, prognosis, diagnosis or monitoring of any breast cancer-related disease, state or condition in humans or animals.
1.26 “ Third Party ” shall mean any Person other than Biosite, Power3 and their respective Affiliates.
1.27 “ Third Party License Agreement ” shall mean a license agreement between Power3 and a Third Party in effect at the time that Power3 designates the applicable proposed target biomolecule under Section 3.1.1(a), or thereafter, which license agreement grants to Power3 a license (with the right to grant sublicenses) under any patent rights or know-how rights that would constitute Power3 Patent Rights or Power3 Know-How Rights relating to such proposed target biomolecule.
1.28 “ Valid Claim ” shall mean (a) a claim of an issued and unexpired patent included within the Power3 Patent Rights that has not been held permanently unpatentable, revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, and (b) a claim of a pending patent application included within the Power3 Patent Rights, which claim was filed in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of such application.
2. REPRESENTATIONS AND WARRANTIES
Each party hereby represents and warrants to the other party as follows:
2.1 Corporate Existence . Such party is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated.
2.2 Authorization and Enforcement of Obligations . Such party (a) has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (b) has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms.
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2.3 Consents . All necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by such party in connection with this Agreement have been obtained.
2.4 No Conflict . The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations and (b) do not conflict with, or constitute a default under, any contractual obligation of such party.
2.5 DISCLAIMER OF WARRANTIES . NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PROGRAM ANTIBODIES OR PROGRAM TARGETS, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT OF THE PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY OTHER PERSON.
3. THE PROGRAM
3.1 Responsibilities .
3.1.1 Target Designation .
(a) Each calendar quarter during the term of the Program, Power3 shall select up to ten (10) target biomolecules from that Power3 desires to use in the Program, provided that at least one half (1/2) of the target biomolecules proposed by Power3 in any such calendar quarter shall be target biomolecules with application in the Exclusive Field and/or Semi-Exclusive Field. With respect to each such target biomolecule with which Power3 desires to conduct immunizations hereunder, Power3 shall provide to Biosite in writing the following information: (i) the common name of such target biomolecule, if any; (ii) other publicly known names of such target biomolecule and any fragment thereof; (iii) the nucleic acid sequence of the gene or cDNA encoding such target biomolecule, or sufficient information to enable access to such sequence from public databases; (iv) identification of the source of biological materials that resulted in the identification of such target biomolecule by Power3 in sufficient detail to allow Biosite to determine the potential disease specificity of such target biomolecule and whether, to the best of Power3’s knowledge, such target biomolecule is difficult to express or to generate antibodies thereto; (v) whether or not Power3 owns or has a licensable interest in any patent or other intellectual property rights in such target biomolecule, antibodies to such target biomolecule or the use thereof, which would be licensed to Biosite as set forth in Section 4.2; (vi) whether or not there exist any Third Party License Agreements relating to such proposed target biomolecule or antibodies thereto, and thereafter during the term of this Agreement Power3 shall notify Biosite of any additional Third Party License Agreements relating to a Program Target or antibodies thereto and provide a description of the applicable financial terms; (vii) whether or not such proposed target biomolecule or antibodies thereto are the subject of a collaboration, research, development, commercialization, out-license or similar agreement between Power3 and any Third Party; and (viii) copies of all patents and patent applications covering such target biomolecule, an antibody thereto, or any use of the foregoing.
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(b) Within thirty (30) days after Biosite receives from Power3 all the information required under Section 3.1.1(a) for a proposed target biomolecule, the parties shall attempt to reach mutual agreement on designating such proposed target biomolecule as a Program Target.
(c) With respect to each proposed target biomolecule that the parties mutually agree to designate as a Program Target, Biosite and Power3 shall discuss in good faith and attempt to reach mutually acceptable agreement regarding the specificity, affinity and other specifications (if any) desired for the antibody to such proposed target biomolecule to be developed under the Program. A proposed target biomolecule that the parties mutually agree to designate as a Program Target shall be designated a Program Target upon the agreement by the parties on the mutually acceptable specificity, affinity and other specifications desired for the antibody thereto.
(d) With respect to each Program Target with which Biosite is to conduct immunizations hereunder, within thirty (30) days after designation of such Program Target, Power3 shall provide Biosite with (i) at least two (2) milligrams of purified protein of such Program Target or a reasonably sufficient quantity of a cell line producing or cDNA clone of such Program Target or cDNA sequence encoding such Program Target; provided that immunizations and antibody development will be delayed by at least three (3) months if a cDNA clone is provided, and an additional period equal to the time reasonably required by Biosite to express the target biomolecule if just the cDNA sequence is provided, and (ii) such information and data regarding such Program Target (including without limitation the nucleotide sequence encoding and the amino acid sequence of such Program Target), as reasonably necessary for Biosite to conduct its obligations under the Program.
3.1.2 Antibody Development and Delivery . With respect to each Program Target, Biosite shall use commercially reasonable efforts (a) to develop antibodies to the Program Target provided by Power3 under Section 3.1.1(d) with the specificity, affinity and such other specifications as mutually agreed by the parties, and (b) to deliver such antibodies within nine (9) months following the date Biosite first conducts immunizations with such Program Target. Biosite shall: (i) make a library of antibodies for each Program Target, (ii) screen the antibodies in such library with the specified antigen or antigen mixture, and (iii) determine which such antibodies satisfy the specificity, affinity and other specifications mutually agreed by the parties. After consultation with Power3, Biosite shall select one Omniclonal Preparation that meets such specifications for each Program Target, and Biosite shall sell and deliver to Power3 a minimum of one milligram (1mg) of such Omniclonal Preparation, and at least twenty (20) Monoclonal Preparations selected from such Omniclonal Preparation.
3.1.3 Limitations on Use . Power3 shall use all Omniclonal Preparations and Monoclonal Preparations sold and delivered by Biosite under Section 3.1.2 solely to conduct its obligations under the Program, or to conduct research. Power3 shall not, and shall not cause or permit any other Person to, use any such Omniclonal Preparation or Monoclonal Preparation sold and delivered by Biosite under Section 3.1.2, other than to conduct its obligations under the Program, or to conduct research.
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3.1.4 Target Validation and Evaluation . Power3 shall conduct such tests (if any) as Power3 determines reasonably necessary to validate each Program Target, to evaluate the potential diagnostic and therapeutic utility of each Program Target, and to otherwise evaluate each Program Antibody.
3.1.5 Sample Analysis .
(a) Upon Biosite’s written request, Power3 shall provide to Biosite, prior to one (1) month following the first delivery of Program Antibodies, non-degraded, intact, properly shipped, blood-based clinical samples (each sample being approximately 2ml, but not less than 1.5ml, in volume) previously obtained by Power3 from its clinical trials being conducted at New York University, Mercy Hospital and OGA (the “Samples”). With respect to each Sample, Power3 shall (i) provide Biosite with such information, that is not subject to confidentiality obligations pursuant to the Health Insurance Portability and Accountability Act (“HIPPA”) and the clinical trial and material transfer agreements under which the Samples and clinical data were collected, regarding such Sample as Power3 has in its possession and control; (ii) have obtained the requisite patient consent forms to permit the use contemplated hereunder of all such Samples and associated clinical data, together with all progeny, products and information derived therefrom, for research and development without compensation to the donor; (iii) prepare and maintain complete and accurate records of Sample sources, donor medical history, Sample procurement and any infectious disease screening, together with any other records regarding the Samples required by applicable laws and regulations; (iv) provide Biosite with copies of all such patient consent forms and records upon request, provided that Power3 shall redact patient names and other patient identifying information for confidentiality purposes; and (v) advise Biosite of any Third Party restrictions applicable to the use of such Samples at the time of, or prior to, providing such Samples to Biosite.
(b) Biosite shall treat all Samples and clinical data as Confidential Information and shall not publish, sell, lease, or otherwise transfer or disclose such Samples and clinical data to any other party without the express consent of Power3; provided, however, that Biosite shall have the right to publish and include in its marketing brochures summaries of the clinical data. Notwithstanding the foregoing, Biosite shall have the right to use all Samples and associated clinical data, together with all progeny, products and information derived therefrom, for research and development purposes, as long as Biosite use complies with HIPPA, Third Party restrictions provided to Biosite under Section 3.1.5(a) above, and any other current or future government regulations governing the transfer and use of such Samples and clinical data.
(c) Biosite shall use commercially reasonable efforts to generate an ELISA-based assay for each Program Target with application in the Exclusive Field and/or Semi-Exclusive Field and for which Biosite has generated appropriate antibodies (as determined by Biosite in its reasonable discretion) under the Program.
(d) If Biosite successfully develops an ELISA-based assay for any such Program Target, Biosite shall analyze each of the Samples provided by Power3 under Section 3.1.5(a) with such assay and shall provide the resulting data to Power3.
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3.1.6 Conduct of Program . Each party shall conduct the Program in good scientific manner, and in compliance in all material respects with all requirements of applicable laws and regulations to attempt to achieve its objectives efficiently and expeditiously. Each party shall proceed diligently with its responsibilities under the Program, and shall allocate such personnel, equipment, facilities and other resources as reasonably necessary to conduct its obligations under the Program and to accomplish the objectives thereof.
3.2 Results .
3.2.1 Reports . Within thirty (30) days following the end of each calendar year during the term of the Program and within thirty (30) days following the expiration or termination of the Program, each party shall prepare, and provide to the other party, a reasonably detailed written report that shall describe the work performed by such party, and the results achieved, to date under the Program, together with copies of all data resulting from the tests and evaluation performed by such party to date under the Program.
3.2.2 Records . Each party shall maintain records, in sufficient detail and in good scientific manner appropriate for patent purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of the Program.
3.2.3 Inspection of Records . Each party shall have the right, during normal business hours and on reasonable notice, to inspect and copy such records of the other party regarding the work done and results achieved in the performance of the Program, to the extent reasonably necessary to enable such party to conduct its obligations under the Program or to exercise its rights hereunder. Each party shall maintain such records of the other party (together with the information contained therein) in confidence in accordance with Section 7 below and shall not use such records (or information) except to the extent otherwise permitted by this Agreement.
3.3 Program Leaders . Each party shall appoint a person (a “Program Leader”) to coordinate its part of the Program. The Program Leaders shall be the primary contacts between the parties with respect to the Program. Each party shall notify the other within thirty (30) days after the date of this Agreement of the appointment of its Program Leader and shall notify the other party as soon as practicable upon changing this appointment.
3.4 Subcontracts . Either party may subcontract portions of the Program to be performed by it in the normal course of its business without the prior consent of the other party; provided, however, that (a) such subcontracting shall not involve the transfer of Confidential Information of the other party to any Third Party unless the subcontracted party shall enter into a confidentiality agreement with the subcontracting party in accordance with Section 7 below; (b) the subcontracting party shall supervise such subcontract work; and (c) the subcontracted party shall be in compliance in all material respects with all requirements of applicable laws and regulations.
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