Give me more for this agreement: This Collaborative Development and Commercialization Agreement ("Agreement") is entered into as of April 26, 2016 ("Effective Date") by and between Microgenics Corporation (hereinafter "Microgenics"), having its principal place of business at 46500 Kato Road, Fremont, California 94538, and Achaogen Inc. (hereinafter "Achaogen"), having a place of business at 7000 Shoreline Court, #371, South San Francisco, California 94080. Both Microgenics and Achaogen are referred to herein individually as a "Party" and collectively as the "Parties." WHEREAS, Achaogen possesses certain intellectual property rights and know-how relating to drug compound Plazomicin; WHEREAS, Microgenics has certain expertise and know-how relating to the development, manufacture and sale of immunoassays for in vitro diagnostic use; WHEREAS, the Parties are undertaking, as of the Effective Date, activities under that certain Antibody Development Agreement, dated ___ (the "Antibody Development Agreement"), for the purpose of identifying and developing antibodies against Plazomicin and this Agreement is the "Assay Commercialization Agreement" referred to in Section 2.6 of the Antibody Development Agreement; and WHEREAS, the Parties desire to collaborate on the development and commercialization of a therapeutic drug monitoring assay for the measurement of concentrations of Plazomicin in biological fluids. NOW THEREFORE, in consideration of the foregoing premises and the covenants and promises contained herein, the Parties intending to be bound, hereby agree as follows: 1. Definitions For the purposes of this Agreement and the Exhibits hereto, the following words and phrases shall have the following meanings (words defined in the Agreement shall have the meaning ascribed to them in that Section): 1.1 "Achaogen Know-How" shall mean all proprietary, technical and clinical information, data and know-how relating to Plazomicin and haptens and polyclonal antibodies related directly to Plazomicin, whether or not patentable, which is Controlled as of the Effective Date or acquired during the Term by Achaogen. 1.2 "Achaogen Materials" shall mean the materials set forth in Exhibit A. 1.3 "Achaogen Patents" shall mean the Patents and Patent applications set forth in Exhibit B hereto. 1.4 "Affiliate" shall mean, with respect to a Party, any corporation, or other business entity which directly controls, is controlled by or is under common control with that Party. A person or entity shall be regarded as in control of another entity if it owns, directly or indirectly, fifty percent (50%) or more of the outstanding equity securities of the subject entity which is entitled to vote in the election of directors, or a fifty percent (50%) or greater interest in the net assets or profits of the subject entity if such entity is not a corporation.
___ Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc. 1.5 "Applicable Law" shall mean all applicable provisions of all statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, awards judgments, permits and licenses of or from governmental authorities, including those relating to or governing the use or regulation of the subject item and the listing standards or agreements of any national or international securities exchange. 1.6 "Assay" shall mean an antibody-based immunoassay or immunoassays used for the in vitro measurement of Plazomicin concentration in human blood and other body fluids, ___, that (a) uses or otherwise would infringe Immunoassay Technologies, (b) is developed by Microgenics and its Affiliates under this Agreement, and (c) ___. 1.7 "Commercially Reasonable Efforts" shall mean efforts and resources normally utilized by a Party for a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into account the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved, the profitability of the applicable products, the relative benefit that accrues to actual and potential patients and other relevant factors; provided, that, in any event, "Commercially Reasonable Efforts" under this Agreement require that a Party (a) ___, (b) ___, and (c) ___. 1.8 "Confidential Information" shall mean all proprietary and confidential business, technical, scientific, and/or regulatory information relating to the Assay, Plazomicin, and/or the purpose of, or activities under, this Agreement, that is provided by or on behalf of a Disclosing Party to a Receiving Party hereunder, whether disclosed in writing or orally. 1.9 "Control" shall mean with respect to any (a) item of information, including know-how, or (b) intellectual property right, the possession (whether by ownership or license) by a Party of the ability to grant to the other Party access and/or a license as provided herein under such item or right without violating the terms of any agreement or other arrangements with any Third Party existing before or after the Effective Date. 1.10 "Development and Manufacturing Phase" shall mean that phase of the Research Program set forth in the Project Plan relating to the optimization of the Assay and the manufacture and validation of ___ (___) production lots of the Assay that meet the Specifications ___. 1.11 "Feasibility Study Phase" shall mean that phase of the Research Program set forth in the Project Plan comprising all studies conducted by Microgenics to establish the feasibility for developing the Assay by demonstrating (a) ___, (b) ___, (c) ___, (d) ___, (e) ___, and (f) ___. 1.12 "First Commercial Sale" shall mean (a) with respect to the Assay, the initial sale by or on behalf of Microgenics (or its Affiliates) of the Assay and (b) with respect to Plazomicin, the initial sale by or on behalf of Achaogen (or its Affiliates) of Plazomicin, in each case, to a Third Party in exchange for cash or some equivalent to which value can be assigned; provided, that a sale of the Assay or Plazomicin, as applicable, in connection with ___ of the Assay or Plazomicin, as applicable, or for ___ therefor will not constitute First Commercial Sale. 1.13 "Good Clinical Practice" or "GCP" shall mean the then current standard for clinical trials for assays, as set forth in the United States Federal Food, Drug and Cosmetics Act and applicable regulations
Page 2 of 60 ___ Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc. promulgated thereunder, as amended from time to time and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries where the Assay is intended to be sold, to extent such standards are no less stringent than United States GCP. 1.14 "Good Laboratory Practice" or "GLP" shall mean the then current standards for laboratory activities for assays, as set forth in the United States Federal Food, Drug and Cosmetics Act and applicable regulations promulgated thereunder, as amended from time to time and such standards of good laboratory practice as are required by the European Union and other organizations and governmental agencies in countries where the Assay is intended to be sold, to extent such standards are no less stringent than United States GLP. 1.15 "Good Manufacturing Practices" or "GMP" shall mean the then current standards for the manufacture of assays, as set forth in the United States Federal Food Drug and Cosmetics Act and applicable regulations promulgated thereunder, as may be amended from time to time and such standards of good manufacturing practice as are required by the European Union and other organizations and governmental agencies in countries where the Assay is intended to be sold, to extent such standards are no less stringent than United States GMP. 1.16 "Immunoassay Technologies" shall mean technologies, including any patentable or unpatentable intellectual property rights appurtenant thereto, Controlled by Microgenics or its Affiliates suitable for developing and manufacturing assays, calibrators and controls for application on ___, including ___ assay technology, ___ technology, ___ technology, ___ immunoassay, the Microgenics Cell Line, and Microgenics ___ Antibodies. 1.17 "Microgenics Cell Line" shall mean those certain cell lines (a) that were developed under the Antibody Development Agreement, or (b) that produce Microgenics ___ Antibodies and are Controlled by Microgenics and listed in Exhibit C, as such Exhibit may be amended from time to time upon the mutual written agreement of the Parties. 1.18 "Microgenics Know-How" shall mean all proprietary, technical information, data and know-how relating to the Assay or Immunoassay Technologies and reagents for use therewith which are Controlled as of the Effective Date or acquired or developed during the Term by Microgenics or its Affiliates. 1.19 "Microgenics ___ Antibodies" shall mean ___ antibodies developed by, or Controlled by, Microgenics or its Affiliates and directed to Plazomicin. 1.20 "Patent" shall mean any existing or future: (a) national, regional or international patent or patent application in any jurisdiction (including any provisional, divisional, continuation, continuation-in-part, non-provisional, converted provisional, or continued prosecution application, any utility model, petty patent, design patent and/or certificate of invention), (b) any extension, restoration, revalidation, reissue, re-examination and extension (including any supplementary protection certificate and the like) of any of the foregoing patents or patent applications, and (c) any ex-U.S. equivalents corresponding to any of the foregoing. 1.21 "Plazomicin" shall mean Achaogen's aminoglycoside antibiotic that is in Phase 3 clinical development as of the Effective Date and having the chemical structure shown on Exhibit D, and ___ thereof, regardless of commercial name.