Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.
Samples The Contractor shall submit the following samples of Materials and relevant information to the Authority’s Engineer for pre-construction review:
(a) manufacturer's test reports and standard samples of manufactured Materials; and
(b) samples of such other Materials as the Authority’s Engineer may require.
Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).
Data To permit evaluation of requests under paragraph (c) of this clause based on unreasonable cost, the Contractor shall include the following information and any applicable supporting data based on the survey of suppliers: Foreign (Nondesignated Country) and Domestic Construction Materials Cost Comparison Construction material description Unit of measure Quantity Cost (dollars) * Item 1: Foreign construction material Domestic construction material Item 2 Foreign construction material Domestic construction material [List name, address, telephone number, and contact for suppliers surveyed. Attach copy of response; if oral, attach summary.][Include other applicable supporting information.] [* Include all delivery costs to the construction site.]
Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.
Evaluation Software If the Software is an evaluation version or is provided to You for evaluation purposes, then, unless otherwise approved in writing by an authorized representative of Licensor, Your license to use the Software is limited solely for internal evaluation purposes in non-production use and in accordance with the terms of the evaluation offering under which You received the Software, and expires 90 days from installation (or such other period as may be indicated within the Software). Upon expiration of the evaluation period, You must discontinue use of the Software, return to an original state any actions performed by the Software, and delete the Software entirely from Your system and You may not download the Software again unless approved in writing by an authorized representative of Licensor. The Software may contain an automatic disabling mechanism that prevents its use after a certain period of time. RESTRICTIONS
Product Information EPIZYME recognizes that by reason of, inter alia, EISAI’s status as an exclusive licensee in the EISAI Territory under this Agreement, EISAI has an interest in EPIZYME’s retention in confidence of certain information of EPIZYME. Accordingly, until the end of all Royalty Term(s) in the EISAI Territory, EPIZYME shall keep confidential, and not publish or otherwise disclose, and not use for any purpose other than to fulfill EPIZYME’s obligations, or exercise EPIZYME’s rights, hereunder any EPIZYME Know-How Controlled by EPIZYME or EPIZYME Collaboration Know-How, in each case that are primarily applicable to EZH2 or EZH2 Compounds (the “Product Information”), except to the extent (a) the Product Information is in the public domain through no fault of EPIZYME, (b) such disclosure or use is expressly permitted under Section 9.3, or (c) such disclosure or use is otherwise expressly permitted by the terms and conditions of this Agreement. For purposes of Section 9.3, each Party shall be deemed to be both the Disclosing Party and the Receiving Party with respect to Product Information. For clarification, the disclosure by EPIZYME to EISAI of Product Information shall not cause such Product Information to cease to be subject to the provisions of this Section 9.2 with respect to the use and disclosure of such Confidential Information by EPIZYME. In the event this Agreement is terminated pursuant to Article 12, this Section 9.2 shall have no continuing force or effect, but the Product Information, to the extent disclosed by EPIZYME to EISAI hereunder, shall continue to be Confidential Information of EPIZYME, subject to the terms of Sections 9.1 and 9.3 for purposes of the surviving provisions of this Agreement. Each Party shall be responsible for compliance by its Affiliates, and its and its Affiliates’ respective officers, directors, employees and agents, with the provisions of Section 9.1 and this Section 9.2.
Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.
System Logging The system must maintain an automated audit trail which can 20 identify the user or system process which initiates a request for PHI COUNTY discloses to 21 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY, 22 or which alters such PHI. The audit trail must be date and time stamped, must log both successful and 23 failed accesses, must be read only, and must be restricted to authorized users. If such PHI is stored in a 24 database, database logging functionality must be enabled. Audit trail data must be archived for at least 3 25 years after occurrence.
Workstation/Laptop encryption All workstations and laptops that process and/or store DHCS PHI or PI must be encrypted using a FIPS 140-2 certified algorithm which is 128bit or higher, such as Advanced Encryption Standard (AES). The encryption solution must be full disk unless approved by the DHCS Information Security Office.
