1.1“Affiliates” means, with respect to a Person, any Person that now or hereafter controls, is controlled by, or is under common control with that first Person. For purposes of this definition only, “control” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through acquisition, ownership of voting securities, or by contract relating to voting rights or corporate governance, or (b) ownership, directly or indirectly, of more than 50% of the outstanding voting securities or other ownership interests of that Person. A Person is deemed to be an Affiliate only as long as such control exists.
1.2“Atreca Antibodies” means (a) Atreca’s monoclonal antibodies [***], (b) the [***] set forth on Schedule 3 and (c) the amino acid sequences of those antibodies described in the foregoing subclauses ((a) and (b)).
1.3“Atreca Biological Materials” means any and all biological materials embodying or derived from the Atreca Antibodies[***].
1.4“Commercialization” means any and all activities related to the commercialization of pharmaceutical products, including marketing, promoting, importing, distributing, offering for sale, or selling of pharmaceutical products (directly or indirectly through multiple levels of distribution), seeking pricing and reimbursement approvals for a pharmaceutical product, if applicable, preparing, distributing and otherwise publishing advertising and promotional materials, and all interactions and correspondence with a Regulatory Authority following Regulatory Approval of a pharmaceutical product. When used as a verb, “Commercialize” means to engage in Commercialization.
1.5“Control” or “Controlled” means, with respect to any Patents, other Intellectual Property Rights, Information, Atreca Biological Materials or Gates MRI Biological Materials, that a Party has the legal authority or right (whether by ownership, license or otherwise, other than pursuant to a license granted to such Party under this Agreement) to grant a license, sublicense, access, or right to use (as applicable) under such Patents or other Intellectual Property Rights, or with respect to such Information, Atreca Biological Materials or Gates MRI Biological Materials, to the other Party on the terms and conditions set forth herein at the time of such grant, in each case without breaching the terms of any agreement with a third party.
1.6“Development” means any and all activities related to the development and Regulatory Approval of pharmaceutical products, including pre- and post-Regulatory Approval research, preclinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, quality assurance/quality control, clinical studies including phase I, phase II, phase III and pricing studies, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis, and report writing with respect to pharmaceutical products. When used as a verb, “Develop” means to engage in Development.
1.7“Gates MRI Biological Materials” means any and all biological materials embodying or derived from the Atreca Antibodies, including [***].
1.8“Information” means all inventions, discoveries, data, information (including scientific, technical or regulatory information), amino acid sequences, processes, methods, techniques, materials, technology, results, analyses, laboratory, pre-clinical and clinical data, and know-how, whether or not patentable, including pharmacology, toxicology, drug stability, chemistry, manufacturing and controls (CMC) data, Manufacturing and formulation methodologies and techniques, quality systems information, clinical and non-clinical safety and efficacy studies and data, analytical data (such as clone characterization data and expression level data), absorption, distribution, metabolism and excretion studies and data, and regulatory information, filings, and supporting data.