Customer Notification By executing this Agreement, the Advisor acknowledges that as required by the Advisers Act the Sub-Advisor has supplied to the Advisor and the Trust copies of the Sub-Advisor’s Form ADV with all exhibits and attachments (including the Sub-Advisor’s statement of financial condition) and will promptly supply to the Advisor copies of all amendments or restatements of such document. Otherwise, the Advisor’s rights under federal law allow termination of this contract without penalty within five business days after entering into this contract. U.S. law also requires the Sub-Advisor to obtain, verify, and record information that identifies each person or entity that opens an account. The Sub-Advisor will ask for the Trust’s legal name, principal place of business address, and Taxpayer Identification or other identification number, and may ask for other identifying information.
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.
Data Loss Prevention Transfer Agent shall implement a data leakage program that is designed to identify, detect, monitor and document Fund Data leaving Transfer Agent’s control without authorization in place.
Product Orders All Product orders shall be submitted by the Operators to DISTRIBUTOR and shall specify the location of the Operator’s Stores, the type of Product, and the quantity desired. Operators may place orders electronically (“Electronic Orders”) or by telephoning or faxing DISTRIBUTOR’s customer service center in accordance with the guidelines detailed below. All shipment expenses from DISTRIBUTOR’s distribution center to the Operator’s location shall be at DISTRIBUTOR’s expense unless otherwise noted elsewhere in this Agreement. Product order guides will be provided by DISTRIBUTOR to the Operators monthly via DISTRIBUTOR’s website and with a hard copy delivered to each Store, with availability of such order guides to be made prior to the beginning of the month, but only after review and approval of the order guide by COMPANY. The order guides will be organized by Product categories and will include, among other things, the Product Sell Price (as defined herein), Product units and new Products. DISTRIBUTOR will assign one product code number to each stock-keeping unit (“SKU”) of each Product, which will be common throughout its entire distribution system and will be used on all documents such as order guides, invoices, monthly reports, etc. SKU’s, and, accordingly, the assigned product code number, must differ for equivalent Products supplied by different suppliers. DISTRIBUTOR will utilize the existing TCBY product item numbers. Only Products approved for sale to its Operators by the COMPANY will be listed on this order guide. Electronic Orders will be placed via internet using DISTRIBUTOR’s web-site. All Electronic Orders are subject to the standard order cut-off time of 4:00 p.m. local time, two (2) days prior to their scheduled delivery day. Operators will have until 5:00 p.m. local time, two (2) days before their order shipping day to modify or add-on to their order. Orders not placed electronically may be subject to earlier cut-off times than those established above as mutually agreed upon between COMPANY and DISTRIBUTOR. Operators will be notified prior to 10:00 a.m. the day after their order cut-off if a product is expected to be out of stock so that an alternative may be ordered, subject to the provisions of Section 3.02. Notwithstanding the foregoing, Stores that have a scheduled delivery day of Monday, must have their orders placed by 12:00 p.m. local time, on the preceding Saturday and Stores that have a scheduled delivery day of Tuesday must have their orders placed by 12:00 p.m. local time, on the preceding Sunday. DISTRIBUTOR may schedule deliveries at any time and day of the week. However, where reasonably possible, DISTRIBUTOR will schedule ordering days and delivery days that are mutually agreed upon by and between DISTRIBUTOR and each Operator and will provide notice to the affected Operator at least fourteen (14) days before routing changes. On an exception basis, DISTRIBUTOR will consider shortening the permissible time frames for scheduled deliveries for those Operators that, given unique and compelling business needs, require the same.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.
Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.
Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.
Sublicense Requirements Any Sublicense:
Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.
