Assumption of Risk and No Guarantee of FDA Approval. Customer acknowledges and agrees that: # Avail’s provision of the Strategic Services may not result in Customer obtaining FDA approval of any premarket tobacco product application (“PMTA”) for any Product, and that Avail may not be able to obtain such approval; # Customer shall have the burden of selecting, in its sole discretion, which of its Product(s) it will submit PMTA’s for to the FDA; and # Products that may generate the highest revenue to Customer may be those that FDA might seek to remove from the marketplace. Customer acknowledges that Avail has disclaimed any guarantee that FDA will approve any PMTA and that Avail’s deliverable to Customer is a PMTA for each Product designated on [Schedule 1] (whether a “Designated Flavor” or “Device”) following strategies outlined by Avail in the PMTA e-Liquids Roadmap, which is included as to this Agreement. For purposes of this Agreement, “Flavor Family” means, with respect to any Designated Flavor, each nicotine strength designated in [Schedule 1] by Customer for such particularly Designated Flavor.
EXCEPT AS OTHERWISE PROVIDED HEREIN, LICENSEE HEREBY EXPRESSLY ASSUMES THE ENTIRE RISK OF USING THE SYSTEM.
No Guarantee. This Agreement shall not be construed and is not intended by either Indemnitee or the Company to be a guarantee, commitment or understanding of Indemnitee’s continued service as a director and/or officer of the Company for any period of time.
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, 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 # imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, # enjoins production at any facility of the Company or any of its Subsidiaries, # enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or # 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.
FDA. There is no pending, completed or, to the Seller's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Seller, and none the Seller has not received any notice, warning letter or other communication from the U.S. Food and Drug Administration (“FDA”) or any other governmental entity, which # 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 wound care product, # 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 wound care product, # imposes a clinical hold on any clinical investigation by the Seller, # enjoins production at any facility of the Seller, # enters or proposes to enter into a consent decree of permanent injunction with the Seller, or # otherwise alleges any violation of any laws, rules or regulations by the Seller. The properties, business and operations of the Seller have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Seller has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any wound care product proposed to be developed, produced or marketed by the Seller nor has the FDA expressed any concern as to approving or clearing for marketing any wound care product being developed or proposed to be developed by the Seller.
No Guarantee of Employment. No provision of this Agreement shall be construed to affect in any manner the existing rights of the Company to suspend, end, alter, or modify, whether or not for cause, the employment relationship of Employee and the Company.
No Guarantee of Employment. Nothing contained in the Plan or this Agreement shall be construed or deemed by any person under any circumstances to bind the Company to grant the Employee any right to remain an Employee of the Company during the vesting period or otherwise or shall interfere with or restrict in any way the right of the Company and its Subsidiaries, which is hereby expressly reserved, to remove, terminate, or discharge Employee at any time for any reason whatsoever.
No Guarantee of Service. This Plan is not a contract for service. It does not give a Participant the right to remain in the service of the Bank, nor does it interfere with the Bank’s right to replace a Participant. It also does not require a Participant to remain in the service of the Bank nor interfere with the Participant’s right to terminate service at any time.
No Guarantee of Employment. Nothing in this Agreement shall be deemed to entitle the Executive to continued employment with the Corporation or any of its Subsidiaries and the rights of the Corporation and its Subsidiaries to terminate the employment of the Executive shall continue as fully as if this Agreement were not in effect; provided that any Qualified Termination of Employment shall entitle the Executive to the benefits herein provided.
No Guarantee of Benefits. Nothing contained in the Plan shall constitute a guarantee by HP or any other person or entity that the assets of HP will be sufficient to pay any benefits hereunder.
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