Human and Financial Resources to Implement Safeguards Requirements The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.
Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.
Additional Products and Services Subject to the allocation of funds, the CPO may add similar equipment, supplies, services, or locations, within the scope of this Agreement, to the list of equipment, supplies, services, or locations to be performed or provided by giving written notification to Contractor. For purposes of this Section, the “Effective Date” means the date specified in the notification from the CPO. As of the Effective Date, each item added is subject to this Agreement, as if it had originally been a part, but the charge for each item starts to accrue only on the Effective Date. In the event the additional equipment, supplies, services, or locations are not identical to the items(s) already under this Agreement, the charges therefor will then be Contractor’s normal and customary charges or rates for the equipment, supplies, services, or locations classified in the Fees and Costs (Exhibit “F”).
Technical Safeguards 1. USAC and DSS will process the data matched and any data created by the match under the immediate supervision and control of authorized personnel to protect the confidentiality of the data, so unauthorized persons cannot retrieve any data by computer, remote terminal, or other means.
2. USAC and DSS will strictly limit authorization to these electronic data areas necessary for the authorized user to perform their official duties. All data in transit will be encrypted using algorithms that meet the requirements of the Federal Information Processing Standard (FIPS) Publication 140-2 or 140-3 (when applicable).
3. Authorized system users will be identified by User ID and password, and individually tracked to safeguard against the unauthorized access and use of the system. System logs of all user actions will be saved, tracked and monitored periodically.
4. USAC will transmit data to DSS via encrypted secure file delivery system. For each request, a response will be sent back to USAC to indicate success or failure of transmission.
Development Standards For any structure built on the Property following the Effective Date, it shall comply with the requirements contained in Exhibit B, “Building Materials,” attached hereto and incorporated herein. The Parties agree and acknowledge that the provisions of this Paragraph shall apply to any structure constructed subsequent to the execution of this Agreement. Nothing in this Agreement shall be deemed to modify or otherwise amend any zoning regulation duly adopted by the Town, previously or in the future.
Procurement Standards For projects being managed by the Local Government and on the State highway system or that include state funding, the Local Government must obtain approval from the State for its proposed procurement procedure for the selection of a professional services provider, a contractor for a construction or maintenance project, or a materials provider.
PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.
Project Delivery Order Procedures The TIPS Member having approved and signed an interlocal agreement, or other TIPS Membership document, may make a request of the awarded vendor under this Agreement when the TIPS Member has services that need to be undertaken. Notification may occur via phone, the web, email, fax, or in person. Upon notification of a pending request, the awarded vendor shall make contact with the TIPS Member as soon as possible, but must make contact with the TIPS Member within two working days. Scheduling of projects (if applicable) may be accomplished when the TIPS Member issues a Purchase Order and/or an Agreement or Contract that will serve as “the notice to proceed” as agreed by the Vendor and the TIPS Member. The period for the delivery order will include the mobilization, materials purchase, installation and delivery, design, weather, and site cleanup and inspection. No additional claims may be made for delays as a result of these items. When the tasks have been completed the awarded vendor shall notify the client and have the TIPS Member or a designated representative of the TIPS Member inspect the work for acceptance under the scope and terms in the Purchase Order and/or Agreement or Contract. The TIPS Member will issue in writing any corrective actions that are required. Upon completion of these items, the TIPS Member will issue a completion notice and final payment will be issued per the contractual requirements of the project with the TIPS Member. Any Construction contract prepared by the TIPS Member’s Legal Counsel may alter the terms of this subsection, “Scheduling of Projects”.
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.
Clinical Supply In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.
