Data Segregation a. DSHS Data must be segregated or otherwise distinguishable from non-DSHS data. This is to ensure that when no longer needed by the Contractor, all DSHS Data can be identified for return or destruction. It also aids in determining whether DSHS Data has or may have been compromised in the event of a security breach. As such, one or more of the following methods will be used for data segregation.
(1) DSHS Data will be kept on media (e.g. hard disk, optical disc, tape, etc.) which will contain no non-DSHS Data. And/or,
(2) DSHS Data will be stored in a logical container on electronic media, such as a partition or folder dedicated to DSHS Data. And/or,
(3) DSHS Data will be stored in a database which will contain no non-DSHS data. And/or,
(4) DSHS Data will be stored within a database and will be distinguishable from non-DSHS data by the value of a specific field or fields within database records.
(5) When stored as physical paper documents, DSHS Data will be physically segregated from non- DSHS data in a drawer, folder, or other container.
b. When it is not feasible or practical to segregate DSHS Data from non-DSHS data, then both the DSHS Data and the non-DSHS data with which it is commingled must be protected as described in this exhibit.
Segregation All Securities and non-cash property held by the Custodian for the account of the Fund (other than Securities maintained in a Securities Depository, Eligible Securities Depository or Book-Entry System) shall be physically segregated from other Securities and non-cash property in the possession of the Custodian (including the Securities and non-cash property of the other series of the Trust, if applicable) and shall be identified as subject to this Agreement.
Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.
(i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field.
(ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.
Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI.
(b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).
Selection Planning Prior to the issuance to consultants of any requests for proposals, the proposed plan for the selection of consultants under the Project shall be furnished to the Association for its review and approval, in accordance with the provisions of paragraph 1 of Appendix 1 to the Consultant Guidelines. Selection of all consultants’ services shall be undertaken in accordance with such selection plan as shall have been approved by the Association, and with the provisions of said paragraph 1.
Data Aggregation Services BA is also permitted to use or disclose information to provide data aggregation services as that term is defined by 45 CFR 164.501, relating to the health care operations of CE.
Claims Review Population A description of the Population subject to the Claims Review.
PRODUCT SUBSTITUTION In the event a specified manufacturer’s Product listed in the Contract becomes unavailable or cannot be supplied by the Contractor for any reason (except as provided for in the Savings/Force Majeure Clause) a Product deemed in writing by the Commissioner to be equal to or better than the specified Product must be substituted by the Contractor at no additional cost or expense to the Authorized User. Unless otherwise specified, any substitution of Product prior to the Commissioner’s written approval may be cause for cancellation of Contract.
Health Spending Account contributions by the Executive will cease on the Effective Date. The Executive may submit claims against the balance accrued to the Effective Date, until the end of the calendar year in which the Effective Date occurs.
Flexible Spending Accounts Employees in the unit shall have access to the County’s flexible spending account program, which provides employees with the options of dependent care assistance benefits with a calendar year maximum of $5,000, and medical expense reimbursement benefits with a calendar year maximum of $2,400. The County shall maintain this plan in compliance with IRC §125. Employee premiums for flexible spending account benefits shall be deducted on a pre-tax basis from employee pay.
