Variance

CONFIDENTIAL.

DO NOT DISCLOSE.

UNAUTHORIZED DUPLICATION STRICTLY PROHIBITED.


Laser Light Company, LLC Variance Agreement

This Agreement is made by and between Laser Light Company, LLC, a Limited Liability corporation having its principal place of business in Florida (“Company”) and, YOU (“Recipient”).

Confidentiality. As used in this Agreement, "Confidential Information" refers to any information, which has commercial value and is either related to Laser Light Company, LLC’s variance process or CDRH and FDA compliance procedures. Specifically included, without limiting the foregoing, is the content of any paperwork generated by either of the Parties intended to certify regulatory compliance with FDA laser safety standards, certification and ongoing compliance testing procedures used with Laser Light Company, LLC products and any training content or materials related to the same. Information which has been authorized to be published by the Company on its website, social media or marketing literature shall be considered the only information which is not confidential in the absence of a written authorization to release.

Nondisclosure and Nonuse Obligations. Recipient will maintain in confidence and will not disclose, disseminate or use any Confidential Information belonging to Company, whether or not in written form. Recipient agrees that Recipient shall treat all Confidential Information of Company with at least the same degree of care as Recipient accords its own confidential information. Recipient further represents that Recipient exercises at least reasonable care to protect its own confidential information.

Survival. This Agreement shall govern all communications between the parties. Recipient understands that its obligations under Paragraph 2 ("Nondisclosure and Nonuse Obligations") shall survive the termination of any other relationship between the parties. Upon termination of any relationship between the parties, Recipient will promptly deliver to Company, without retaining any copies, all documents and other materials furnished to Recipient by Company. This agreement will continue for a period of five (5) years from the date of execution.

Governing Law. This Agreement shall be governed in all respects by the laws of the United States of America and by the laws of the State of Florida (Orange County).

Injunctive Relief. A breach of any of the promises or agreements contained herein will result in irreparable and continuing damage to Company for which there will be no adequate remedy at law, and Company shall be entitled to injunctive relief and/or a decree for specific performance, and such other relief as may be proper. Recipient also agrees to reimburse Company for all attorney’s costs related to enforcement of this agreement if the Company is granted injunctive relief, decree for specific performance, damages or any other similar court action in favor of the Company.

Limitation of Liability. Recipient agrees to hold harmless, indemnify and defend Company
against all claims arising from the use of the Company’s products and agrees to promptly notify
the Company if any product defect or safety concern becomes known to Recipient and
discontinue use of the Company’s products until any such situation has been resolved to Recipient's satisfaction. Recipient agrees to use Company’s products only in accordance with
the terms of an FDA variance and to maintain Recipient’s variance in full effect during any use
of Company’s products. In all cases Recipient shall assume full responsibility of correctly using the Company’s products in accordance with local and national regulations and industry best
practices. Recipient agrees to hold harmless, indemnify and defend Company against all claims arising from Laser Light Company, LLC’s actions in preparing, filing, or modifying regulatory filings or responding to agency communications including, but not limited, loss of use due to agency
actions, delays or inactions.
Regulatory Confidentiality Waiver: In order to allow Laser Light Company, LLC to act on Recipient's behalf in communicating with government regulatory and enforcement agencies, the below signed Recipient expressly waives all confidentiality rights which would restrict the transfer of documents or verbal information related to any Recipient laser compliance matter. The below signed Recipient hereby appoints Laser Light Company, LLC as Recipient’s agent and authorizes Laser Light Company, LLC to examine, discuss and modify Recipient’s regulatory filings and/or agency generated correspondence with any agent of a relevant local or federal agency.
Nothing Construed. Nothing in this agreement shall be construed to obligate Laser Light Company, LLC to act on Recipient’s behalf on any matter and Recipient agrees that Laser Light Company, LLC has not be retained to perform any specific scope of work or task beyond effecting the filing of standard variance forms to the FDA. Recipient agrees to notify Company within 30 days if recipient has not been issued a notification of filing and accession number from the FDA.

Entire Agreement. This Agreement constitutes the entire agreement with respect to the Confidential Information disclosed herein and supersedes all prior or contemporaneous oral or written agreements concerning such Confidential Information. This Agreement may only be changed by mutual agreement of authorized representatives of the parties in writing.

Yes (I Agree) No (I Do Not Agree)