Hello new recruit! 

SECTIONS 9-10

9. CONFIDENTIAL INFORMATION AND NON-COMPETE

1. Sales Agent acknowledges that it will have access to certain Confidential Information relating to the Company or its affiliates (the “Company Group”). “Confidential Information” shall mean confidential and proprietary information of the Company Group, whether in written, oral, electronic or other form, including but not limited to the internal organization of the Company Group, the names and responsibilities of its management, supervisory and technical employees, operating plans, inventions, research and development activities and the members of development teams, plans for acquisitions and mergers, manufacturing and/or sales activities, technical information concerning Products and related instrumentation, specifications, procedures, techniques, ideas, methods, Intellectual Property, commission rates and the names of Accounts and suppliers. Confidential Information also includes the terms and existence of this Agreement, including but not limited to the exhibits attached hereto, and all disclosures made during the negotiations of this Agreement in its entirety.

2. Sales Agent covenants not to disclose any Confidential Information or make use of it, except for purposes authorized by this Agreement, and will not disclose any Confidential Information to any person or firm unless previously authorized in writing to do so; provided, however, that Sales Agent may disclose it as necessary to responsible officers, employees and agents for the purposes of performing its obligations under this Agreement, provided that such employees, officers and agents shall have assumed like obligations of confidentiality in writing. Sales Agent shall take commercially reasonable precautions to protect the confidentiality of the Confidential Information and, in any event, shall undertake the same measures to protect the confidentiality of such Confidential Information as Sales Agent takes to protect its own Confidential Information.

3. The restrictions on use and disclosure of Confidential Information set forth in this Section 9 shall not apply: (i) to the extent that the Confidential Information is in the public domain without the negligence or fault on the part of Sales Agent or any third party; or (ii) disclosures that are mandated by court order, provided that Sales Agent notifies the Company prior to such disclosure and takes reasonable actions to limit the disclosure of such Confidential Information.

4. Upon the Company’s written demand or upon expiration or termination of this Agreement, Sales Agent, at its own cost and expense, will promptly return all Confidential Information to the Company to the extent held or controlled by Sales Agent in written, graphic or other tangible form, and all copies, summaries, notes and other write-ups thereof made by Sales Agent, or its employees or agents. The terms of this Section 9 shall survive indefinitely the termination or expiration of this Agreement.

5. Sales Agent may not market, promote, sell or solicit for sale any Competitive Products (as hereinafter defined) at any time during this Agreement or for a period of twenty four (24) months following expiration or termination of this Agreement. The term “Competitive Products” means any human cells, tissues, or cellular or tissue-based products (“HCT/Ps”) or technologies that are substantially similar to or that compete with any of Product(s).

6. ​

10. TERM AND TERMINATION

1. This Agreement will become effective upon the Effective Date and will continue until the second anniversary of the Effective Date (the “Initial Term”). Following the Initial Term, unless either party provides ninety (90) days written notice of the intent not to renew in advance of expiration, this Agreement shall automatically renew for subsequent one (1) year terms. Each renewal period shall be considered a “Renewal Term,” and together with the Initial Term, shall be referred to herein as the “Term.” In advance of any expiration of this Agreement, Company may alternatively provide ninety (90) days written notice of its intent to renew the term of this Agreement with modified terms, to be identified in Company’s notice issued to Sales Agent. If, following receipt of such notice of renewal with modified terms, Sales Agent continues to sell Products, Sales Agent shall be deemed to have accepted the terms and conditions set forth in such notice of renewal.

2. This Agreement may be terminated by the Company as follows: (i) at any time during the term of this Agreement; or (ii) at any time if Sales Agent becomes insolvent or bankrupt, or files a voluntary petition in bankruptcy, or has filed for an involuntary petition in bankruptcy; or (iii) if Sales Agent fails to cure any breach of a covenant, commitment or obligation under this Agreement within thirty (30) days after receipt of notice from the Company of such breach; (iv) effective immediately in the event that Sales Agent: fails to comply with the compliance obligations set forth in Exhibit D; violates a Healthcare Law (or is subject to an investigation by a governmental entity in connection with any actual or suspected violation); is debarred, excluded, or suspended from participation in any federal or state healthcare program (as defined under 42 U.S.C. § 1320a-7b); or engages in conduct that reasonably would be expected to result in or would provide reasonable cause for debarment, exclusion, suspension, civil, criminal, or administrative penalties, or any other penalty or sanction under a Healthcare Law. Notwithstanding the preceding sentences and in lieu of terminating the Agreement, the Company reserves the right to unilaterally modify Exhibit A by providing Sales Agent written or electronic notice of the modification.

3. This Agreement may be terminated by Sales Agent as follows: (i) at any time if the Company becomes insolvent or bankrupt, or files a voluntary petition in bankruptcy, or has filed for an involuntary petition in bankruptcy; or (ii) if the Company fails to provide a mutually agreed upon corrective action plan for any breach of a covenant, commitment or obligation under this Agreement within thirty (30) days after receipt of written notice from Sales Agent of such breach.

4. Following the termination or expiration of this Agreement: (i) Sales Agent shall immediately discontinue all sales promotion and distribution of the Products; (ii) Sales Agent will immediately return all Samples to the Company; (iii) Service Fees shall be pro-rated for any partial periods of performance prior to termination; (iv) Company shall have no payment obligation to Sales Agent with respect to activities after the termination, including Service Fees for orders generated (but for which a customer has not yet paid Company) while still under valid agreement; and (v) the Company and Sales Agent will undertake in good faith within 90 days to reconcile all matters pertaining to commission and other amounts, if any, owed by either party.

In the event of a disagreement between the parties as to whether an account should be included on this Exhibit A, the  Company shall have final decision-making authority.  Other than as expressly set forth in this Agreement, the parties agree that this Exhibit A may only be amended upon the  written agreement of the parties. 

List of Accounts:  
• Accounts as assigned below

1. Sales Agent understands and acknowledges that all Products must be marketed and sold only on the basis of quality,  service, price, and other legitimate clinical attributes, and that Sales Agent is prohibited from providing any payment  or any other thing of value to any person or entity as an inducement to order or recommend Products.  

​

2. Internal Compliance Program. Sales Agent shall maintain an internal compliance program, including at a minimum  the following elements:       a. Assignment of overall responsibility for compliance to an appropriate officer of Sales Agent, whose  responsibilities will include coordinating Sales Agent’s compliance obligations under this Agreement; and  corresponding and coordinating with Company as needed on compliance issues or questions that arise;  

    b. In support of Sales Agent’s compliance reporting obligations under this Agreement, establishment of effective  lines of communication for reporting compliance questions and concerns, the regular publicizing of these lines  of communication, and effective procedures for discipline, investigation and resolution;  

    c. Regular monitoring of Sales Agent’s compliance; and  

    d. Compliance training for Sales Agent employees and agents who provide services related to this Agreement,  which shall include training on compliance with Healthcare Laws and communication or distribution of  applicable Company policies, within thirty (30) days of hire and annually thereafter.  

​

3. Sunshine Act. If Sales Agent makes reportable payments or transfers of value under the federal Physician Payments  Sunshine Act (the “Sunshine Act”) to any physicians or qualified healthcare provider (i.e., MD, DO, OD, DC, DPM,  DDS), advance practice nurses, physician assistants or teaching hospitals on behalf of Company, Sales Agent shall  be responsible for collecting and submitting to Company any information that Company is required to report to the  government (“Covered Information”). Sales Agent will be responsible for timely implementing processes and  systems necessary to capture, store and report to Company all Covered Information. Sales Agent will be responsible for the accuracy and completeness of its Covered Information. Sales Agent will be responsible for any and all costs incurred by the Company as a result of inaccuracy or incompleteness, including, without limitations, fines and penalties levied by the federal government against Company. Sales Agent will retain complete records of all  Covered Information for the period required under the Sunshine Act and will make such records available for periodic audit by Company.  

​

4. Background Check. Upon contract execution and at least annually thereafter, Sales Agent must:

    (i) review each employee or agent providing services under the Agreement against, at minimum, the HHS-OIG LEIE database,  FDA debarment list, and SAM database .

   (ii) perform state and federal criminal background checks and a National  Sex Offender database check. Sales Agent must maintain the results of background checks in the employee’s or contractor’s file for a minimum of seven (7) years. If the background check reveals that an individual is excluded or listed in a sex offender database, the individual or entity may not be engaged or employed to provide services under this Agreement. If the criminal background check reveals a criminal record, Sales Agent must contact the  Company for further direction. The Company reserves the right to request proof from Sales Agent at any time that  the above screening is being conducted as described.  

​

5. Patient Instruction. If Sales Agent will be providing training to customers or patients on the use of Company  Products, Sales Agent agrees to ensure that its employees and agents provide appropriate training and education to each customer and patient, the content of which shall be reviewed and approved by the Company in advance.  

​

6. FDA Compliance Obligations  

    a. Sales Agent shall comply with all applicable FDA regulations and guidance.  

    b. Sales Agent shall promptly, and in any event within two (2) business days after the date of receipt of notice, notify the Company in writing of, and shall provide the Company with copies of, any correspondence and  other documentation received or prepared by Sales Agent in connection with any of the following events:  

        i. receipt of a regulatory letter, warning, recall notice, notice of inspection or similar communication from  any governmental or regulatory authority in connection with the Product(s); and  

        ii. any governmental or regulatory authority’s comments relating to the Product(s) that may require a response or action by the Company.  iii. Sales Agent shall promptly provide to the Company any data, information, assistance, and cooperation that may be required by the Company to prepare a response to any of the foregoing events that relate to storage, marketing, advertising, sale or distribution of the Product(s) (regardless of whether Sales Agent has received any governmental or regulatory communication or documentation in connection with the event).  

    c. Sales Agent communications and representations to customers and patients shall be true, accurate, complete,  and consistent with the labeling of Company Products.  

    d. Under no circumstances will Sales Agent take custody of or handle product. To the extent Sales Agent inadvertently receives returned Product(s) from a customer(s), Sales Agent shall immediately contact  Company for instructions on handling of such Product in accordance with the Product’s IFUs noted on each  Product’s packaging or IFU furnished by the Company and applicable standard operating procedures, as they  may be modified from time to time. Such incidental receipt of returned Products by Sales Agent and its further  shipment to the Company does not involve distribution of Products, but rather relates solely to their return to the Company.  

    e. Sales Agent shall assist the Company in performing physician notification, Product recall, and/or patient  notification if reasonably requested by the Company or required as a result of a regulatory enforcement action  with respect to Products.  

​

7. Complaints. Each party shall cooperate fully with the other party in dealing with customer complaints concerning  Product(s) and shall take reasonable action to resolve promptly and follow up with regard to such complaints.  Without limiting the generality of the foregoing, Sales Agent shall:

        (i) notify the Company within two business days  of receiving all complaints);

        (ii) provide copies to the Company within a commercially reasonable time of all  customer complaints received by Sales Agent relating to Product(s);

        (iii) keep and maintain records of all customer  complaints received by Sales Agent relating to Product(s); and 

        (iv) otherwise provide such assistance and  information as the Company reasonably requests to fulfill the Company’s complaint handling obligations for  Product(s).  

8. Adverse Reaction, HCT/P Deviation, and other mandatory reporting. The Company shall be responsible for  reporting adverse reactions, HCT/P deviations, and other reportable events related to the Product(s) pursuant to the  applicable Healthcare Laws. Sales Agent shall provide such assistance and information as the Company reasonably  requests to fulfill its reporting obligations for Products.  

9. Reports. Upon request, Sales Agent will provide the Company with copies of all pertinent correspondence with and  from any governmental agency (including the FDA) concerning the Products or the subject matter of this Agreement,  which may include, but shall not be limited to, inspection reports containing negative findings, enforcement actions,  regulatory approval applications or actions, or any other document which could affect the federal regulatory status  of the Products, or components thereof, as discussed or described in this Agreement.  

10. Regulation of Sale of Human Tissue. The parties agree and understand that the Products are human allograft tissue  products. According to the U.S. National Organ Transplant Act (“NOTA”) (42 U.S.C. § 274e, as amended), human  tissue cannot be sold and is not the property of any entity. The services provided by a tissue bank and third parties  include recovery, processing, storage, distribution, marketing, and processing of orders for human tissue to a  recipient in a form that is suitable for clinical use and that is helpful in restoring the recipient's form or function.  Passing the costs of such services on to recipients is not considered the sale of human tissue as defined under NOTA.  As such, the parties agree and understand that references to the sale and/or purchase of Products throughout the  Agreement do not refer to the sale of human tissue, but refer to the payment of processing fees for the Products and  the distribution of the Products from Company to customers.  

11. Conflict of Interest. Sales Agent is prohibited from engaging in any activity, practice, investment, association or act  that conflicts with, or appears to conflict with, the interests of the Company or its affiliated companies, customers,  or suppliers. Sales Agent must disclose any financial interest it has in any firm that does business with or competes  with the Company. Sales Agent shall not give, offer, or promise, directly or indirectly, anything of value to any a  customer, a potential customer of the Company, or to a financial institution or to any government official to induce  or in connection with any transaction or business that the Company may have with such customer, financial  institution or official. Sales Agent shall ensure that its employees and agents are subject to the same prohibitions  concerning actual or potential conflicts with Company interests and the provision of items of value in connection  with Company-related business.  

12. Patient Privacy. To the extent applicable, Sales Agent shall take all necessary measures to comply with laws  governing patient privacy and data security, including but not limited to the Health Insurance Portability and  Accountability Act (“HIPAA”).