Cover, Covering or Covered means that, with respect to a product or technology and a Patent, but for ownership of or a license under such Patent, the Development, Manufacture, Commercialization or other use of such product or practice of such technology by a Person would infringe a claim of such Patent or, with respect to a claim included in any patent application, would infringe such claim if such patent application were to issue as a patent.
Damages means all claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including reasonable legal expenses, costs of litigation and reasonable attorneys fees), or judgments, whether for money or equitable relief, of any kind; provided that no Party shall be liable to hold harmless or indemnify the BeiGene Indemnified Parties or BioAtla Indemnified Parties, as applicable, for any claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs or judgments for punitive or exemplary damages, except to the extent the Party seeking indemnification is actually liable to a Third Party for such punitive or exemplary damages in connection with a Claim by such Third Party.
Data means any and all research data, results, pharmacology data, medicinal chemistry data, preclinical data, market research, clinical data (including investigator reports (both preliminary and final), statistical analysis, expert opinions and reports, safety and other electronic databases), in any and all forms, including files, reports, raw data, source data (including patient medical records and original patient report forms, but excluding patient-specific data to the extent required by applicable Laws), in each case, generated by or on behalf of a Party with respect to the Candidate or any Product pursuant to this Agreement.
Develop or Development means all research, preclinical, non-clinical and clinical development activities, including activities relating to screening, assays, test method development and stability testing, toxicology, pharmacology, formulation, quality assurance/quality control development, the conduct of Clinical Trials, technology transfer, statistical analysis, process development and scale-up, pharmacokinetic studies, data collection and management, report writing and other pre-Regulatory Approval activities. For clarity, Development does not include any Manufacture or Commercialization activities.
Development Plan means a development plan and the related Development Budget for the Development activities to be conducted with respect to a Candidate or a Product pursuant to this Agreement as approved by the Parties, and as amended from time to time pursuant to Section 3.1(a); it being understood and agreed that, prior to the POC Milestone Date, the Development of the Candidates and the Products shall be governed by the Development Plan attached hereto as Schedule 3.1.
Direct Cost means, with respect to certain Collaboration Activities hereunder, the direct expenses paid or payable by either Party or its Affiliates to Third Parties and employee expenses calculated in accordance with the applicable FTE Rate that are specifically identifiable and incurred to conduct such Collaboration Activities hereunder and have been recorded in accordance with the Accounting Standards; provided, however, that, solely with respect to employee expenses that are included as Direct Costs, if there is a conflict between the applicable FTE Rate and what would have been recorded in accordance with Accounting Standards, the FTE Rate shall apply.
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