UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2017
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from to
Commission File Number: 000-10093
FUSE MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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59-1224913 |
(State or other jurisdiction
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(I.R.S. Employer Identification No.) |
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1565 North Central Expressway, Suite 220, Richardson, Texas |
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75080 |
(Address of principal executive offices) |
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(Zip Code) |
(469) 862-3030
Registrant’s telephone number, including area code
Securities registered pursuant to section 12(b) of the Act:
Title of each class |
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Name of each exchange on which registered |
None |
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None |
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 par value
(Title of class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ☐ Yes ☒ No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). ☒ Yes ☐ No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy information statements incorporated by reference in Part III of this Form 10-K or any amendments to this Form 10-K ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company. See definition of “large accelerated filer,” “accelerated filer,” and “small reporting company” Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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(Do not check if a smaller reporting company) |
Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has selected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: $2,205,059 .
Indicate the number of shares outstanding of each of the registrant’s classes of Common Stock, as of the latest practicable date: As of March 26 , 2018, 65,890,808 shares of the registrant’s Common Stock were outstanding.
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ITEM 1. |
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ITEM 1A. |
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ITEM 1B. |
13 |
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ITEM 2. |
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ITEM 3. |
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ITEM 4. |
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ITEM 5. |
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ITEM 6. |
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ITEM 7. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
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ITEM 7A. |
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ITEM 8. |
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ITEM 9. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. |
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ITEM 9A. |
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ITEM 9B. |
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ITEM 10. |
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ITEM 11. |
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ITEM 12. |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS. |
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ITEM 13. |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE. |
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ITEM 14. |
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ITEM 15. |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains forward-looking statements, including, without limitation, in the sections captioned “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere. Any and all statements contained in this Annual Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future,” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Annual Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations; (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items; (iii) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”); (iv) our beliefs regarding potential clinical and other health benefits of our medical products; and (v) the assumptions underlying or relating to any statement described in clauses (i), (ii), (iii), or (iv) above.
Forward-looking statements are not meant to predict or guarantee actual results, performance, events, or circumstances and may not be realized because they are based upon our current projections, plans, objectives, beliefs, expectations, estimates, and assumptions and are subject to a number of risks, uncertainties, and other influences, many of which we have no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation: (a) our inability to obtain adequate financing; (b) the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity; (c) our inability to expand our business; (d) significant government regulation of our business and the healthcare industry; (e) lack of product diversification; (f) existing or increased competition; (g) results of arbitration and litigation; (h) stock volatility and illiquidity; and (i) our failure to implement our business plans or strategies. Descriptions of some of the risks and uncertainties that could cause our actual results to differ materially from those described by the forward-looking statements in this Annual Report appear in “Item 1A, Risk Factors” and elsewhere in this Annual Report.
Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We disclaim any obligation to update the forward-looking statements contained in this Annual Report to reflect any new information, future events or circumstances, or otherwise.
Readers should read this Annual Report in conjunction with (1) the discussion under the caption “Risk Factors,” (2) our financial statements and the related notes therein included in this Annual Report, and (3) other documents which we may file from time to time with the SEC.
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Historical Company Information
We were initially incorporated in 1968 as GolfRounds, Inc., a Florida corporation. During July 1999, GolfRounds, Inc. was re-domesticated to Delaware through a merger into its wholly-owned subsidiary GolfRounds.com, Inc. Effective May 28, 2014, GolfRounds.com, Inc., amended its certificate of incorporation to change its name to Fuse Medical, Inc. (“Fuse” or our “Company”) and merged with and into Fuse Medical, LLC, with Fuse Medical, LLC surviving as a wholly-owned subsidiary of Fuse. The transaction was accounted for as a reverse merger. Fuse was the legal acquirer, and Fuse Medical, LLC was deemed the accounting acquirer. During 2015, certificates of termination were filed for Fuse Medical, LLC and its two subsidiaries.
Change-in-Control
Since December of 2016, we have been controlled by two primary stockholders: NC 143 Family Holdings, LP, a family limited partnership controlled by Mark W. Brooks (“NC 143”), our Chairman of the Board of Directors (the “Board”) and President; and Reeg Medical Industries, Inc. (“RMI”, and together with NC 143, the “Investors”), an investment holding company owned and controlled by Christopher C. Reeg, our Chief Executive Officer and Secretary.
On December 19, 2016 (the “Change-in-Control Date”), we entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) by and between the Investors and our Company, pursuant to which NC 143 acquired 5 million shares of our common stock, par value $0.01 per share (“Common Stock”), for a purchase price of $400,000 and RMI acquired 4 million shares of our Common Stock for a purchase price of $320,000 (collectively the “Investor Shares”), effective as of the Change-in-Control Date.
The closing of the Stock Purchase Agreement resulted in a change-in-control of our Company whereby the Investors beneficially acquired approximately 61.4% of our Common Stock issued and outstanding immediately after the Change-in-Control Date. Mark W. Brooks became our Chairman of the Board and Christopher C. Reeg became our Chief Executive Officer, as described in our Current Report on Form 8-K, filed with the SEC on December 23, 2016, which is herein incorporated by reference.
CPM Acquisition
On December 15, 2017, we entered into an agreement with NC 143 pursuant to which we would purchase all of the outstanding membership interests of CPM Medical Consultants, LLC (“CPM”) as disclosed in our Current Report on Form 8-K, dated December 19, 2017, with the SEC (the “CPM Acquisition Agreement”), which is herein incorporated by reference (such transaction, the “CPM Acquisition”).
On December 29, 2017, we completed the previously-announced CPM Acquisition, pursuant to the CPM Acquisition Agreement. We issued 50 million shares of our Common Stock in exchange for 100% of the outstanding membership interests of CPM, at an agreed-upon value of $0.20 per share of Common Stock, as disclosed in our Current Report on Form 8-K, filed January 5, 2018, and amended by our Current Report on Form 8-K/A, dated March 12, 2018, which are both herein incorporated by reference. The effective date of the CPM Acquisition was December 31, 2017 (the “Effective Date”).
On the Effective Date and following the closing of the CPM Acquisition, NC 143 and RMI beneficially held approximately 90.4% of our Common Stock outstanding and Common Stock from convertible promissory notes if converted – as more fully described in “Item 13, Certain Relationships and Related Transactions, and Director Independence” contained in this 2017 Annual Report.
In the CPM Acquisition, Fuse was the legal acquirer and, for accounting purposes, CPM was deemed to have acquired Fuse. As a result, this Annual Report on Form 10-K for 2017 (this “2017 Annual Report”) reflects CPM as the reporting entity for 2017 and 2016 and is consolidated with Fuse from and effective on the Change-in-Control Date.
We are a “smaller reporting company” as that term is defined in Rule 12b-2 promulgated under the Securities Exchange Act of 1934, as amended (“Exchange Act”). Accordingly, this 2017 Annual Report will reflect the reporting requirements of smaller reporting companies as set forth in Regulation S-K, promulgated under the Exchange Act.
Overview
We are a national distributor of medical devices, providing a broad portfolio of orthopedic implants including: (i) internal and external fixation products; (ii) upper and lower extremity plating and total joint reconstruction implants; (iii) soft tissue fixation and augmentation for sports medicine procedures; (iv) full spinal implants for trauma, degenerative disc disease, and deformity indications (collectively, “Orthopedic Implants”); and (v) a wide array of osteo-biologics and regenerative tissue which include human allografts,
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substitute bone materials , tendons, and regenerative tissues and fluids (“Biologics”). All of our medical devices are approved by the U.S. Food and Drug Ad ministration (“FDA”) for sale in the United States, and all of our Biologics suppliers are licens ed tissue banks accredited by the American Association of Tissue Banks (“AATB”) .
We believe our broad portfolio of Orthopedic Implants and Biologics provide high-quality products to assist surgeons with positive patient outcomes and cost-effective solutions for our customers, which include hospitals, medical facilities, and sub-distributors. We operate under exclusive and non-exclusive agreements with our vendors and supply partners in the geographic territories that we serve.
We pride ourselves on developing strong and collaborative supplier relationships, resulting in strong long-term partnerships with broad diversification. Currently we maintain relationships with approximately 51 different suppliers, with our top five suppliers representing approximately 32% of our consolidated cost of revenue and our top ten suppliers representing more than 50% of our consolidated cost of revenues.
One of our Biologics suppliers is Vivex Biomedical, Inc., a biomedical company, focused on cellular therapies that treat orthopedic, spine, wound, and soft tissue indications. OrthoSolutions Group Ltd. and Vilex in Tennessee, Inc. are two of our suppliers of Orthopedic Implants for lower extremities as well as FH Orthopedics, Inc. for shoulder replacement systems. Two of our other suppliers are Precision Spine, Inc. and Spinal Elements, Inc. for medical devices used in spine surgeries. We also have an agreement dated November 1, 2016, with Tyber Medical, LLC, a manufacturer of Orthopedic Implants, substantially in the form attached hereto as Exhibit 10.13, to develop and expand our private label initiatives.
We continuously review and expand our product lines to ensure we offer the most comprehensive, high-quality, and cost-effective selection of Orthopedic Implants and Biologics so that we can meet and exceed our customers’ needs while continuing to grow our existing customer base.
We are currently negotiating new stocking distribution agreements with two manufacturing companies for non-exclusive distribution rights in the United States for their total knee and total hip replacement systems. We are also evaluating the opportunity to license those manufacturing companies’ technology for our own branding opportunities.
We utilize our physical relationships, corporate partners, facility contracts and distribution channels, as well as their knowledge of the healthcare industry to further our business objectives and believe all sales are generated with transparency and the highest ethical standards. We continue to build our network of surgeons in select clinical specialties, many of whom we believe are leaders in their respective fields. These medical leaders and specialists may include the heads of teaching hospitals and universities, clinical residency programs, and clinical fellowship programs at some of the most respected institutions in the nation. We are currently in the process of creating product line advisory boards whereby these industry leaders will provide us with valuable insight to further our product development.
Product Distribution Channels and Customer Base
We utilize multiple distribution models including direct sales representatives and independent contractors. Our largest customers are hospitals and surgical facilities. We primarily resell products that we acquire directly from large medical device manufacturers or from authorized distributors. Our sales to hospitals and surgical facilities for the years ended December 31, 2017 and 2016 were approximately 62% and 71%, respectively. Our sales to distributors on a wholesale basis for the years ended December 31, 2017 and 2016 were approximately 38% and 27%, respectively.
Competition
We primarily compete with large, vertically-integrated medical device manufactures that enjoy well-established distribution channels, national sales networks, direct sales models, and participation in large group purchasing organizations (“GPO”) contracted with major hospitals and surgery centers. Our competitors incentivize physicians, surgeons, and specialists’ opportunities through consulting agreements, clinical trials remuneration, royalties, and other compensation models.
Generally, we view Stryker Corporation, Smith & Nephew, and Orthofix International, N.V., as examples of our vertically-integrated competitors. We believe our competitors, and companies like them, only distribute products they manufacture and have significant costs related to research and development and organizational support. On the other hand, we sell many manufacturers’ products and have no costs related to research and development, nor do we have similar costs for organizational support, because we are not vertically-integrated. Thus, we believe that our competitive advantage lies primarily with our single-source fulfillment sales model, allowing us to offer a broader assortment of several manufacturers’ products. Furthermore, without significant costs associated with research and development or organizational support, we believe that the compensation packages we offer to our sales team have higher-earning potentials than the compensation packages our competitors offer, allow us to attract and retain talented employees.
We partner primarily with small- and medium-sized manufacturers of Orthopedic Implants that are subject to FDA compliance and approval standards. These manufacturers are highly innovative and cost effective because of their streamlined sales infrastructures.
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Because of our organizational structure and our sales model, we tend to align well with our suppliers’ competitive strategies, meaning they will partner with us over a competitor . Moreover, we believe that m any of the large manufacturers of Orthopedic Implants ha ve patents that have ex pired or will soon expire on types of products we currently distribute or anticipate distributing. As a result, we believe those products will cease to carry a premium and will become commoditized. We believe that expiration of these patents and resulting commoditization will create significant opportunities for us to become a go-to distributor for these products at a lower price point than is currently available on the market.
The market in which we operate is sensitive to changes in third-party and government reimbursements and to a lesser degree competitive discount pricing. We believe that our industry will see increased consolidation because the market is significantly fragmented with numerous medical device distributors offering similar product portfolios throughout the United States.
Intellectual Property
Our intellectual property includes trademarks pending for our private label portfolio, trade secrets, and intellectual property licenses arising out of our distribution agreements (“IP”). Our private label portfolio consists of (i) our amniotic membrane line that includes AmBioChoice and AmBioChoice Plus; (ii) our internal fixation product line that includes small bone screws; and (iii) our cervical and lumbar spinal implant line. We have applied for trademarks on our AmBioChoice and AmBioChoice Plus products. We are pursuing intellectual property license and purchase agreements to secure additional intellectual property for our use. Although we have not entered into any material agreements to date for the purchase or license of intellectual property, we believe that in the next calendar year we will identify and acquire viable intellectual property for use in our business. We also maintain stocking distribution agreements providing for exclusive distribution rights in certain geographic areas and use of associated trademarks, service marks, and tradenames for the sale and promotion of the products we offer, which generally have terms of one year, subject to renewal terms. Furthermore, we require leased employees, independent contractors, consultants, and advisors to execute assignment agreements that assign to us the IP existing and generated from their work. We believe our IP and exclusive distribution agreements provide us with important competitive advantages by (a) increasing our brand awareness and the brand awareness of the products we distribute; and (b) insuring that we use the latest design and manufacturing technology for our products.
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Our business is subject to highly complex United States federal and state regulations that may impact our ability to fully implement our strategic plans and initiatives. We are required to obtain and hold licenses and permits and to comply with the regulatory requirements of various governmental agencies. If we fail to comply with such regulatory requirements or if allegations are made that we fail to comply with such regulations, the economic viability of our Company may be adversely affected.
FDA Regulations
The manufacturers and suppliers of the products we market are subject to extensive regulation by the FDA, other federal governmental agencies, and state authorities. These laws and regulations govern the approval of, clearance of, or license to commercialize Orthopedic Implants and Biologics, including compliance with the standards and requirements related to the design, testing, manufacture, labeling, promotion, and sales of the products, record keeping requirements, tracking of devices, reporting of potential product defects and adverse events, conduct of corrections, and recalls and other matters. As a distributor and marketer of such FDA-regulated products, we may be subject to independent requirements to register and list certain products. We may be required to obtain state licensure or certifications and we may be subject to inspections, in addition to complying with requirements that apply to the manufacturers of the products we market. Failure to comply with those applicable requirements could result in a wide variety of enforcement actions, ranging from warning letters to more severe sanctions such as fines and civil penalties, operating restrictions, injunctions, and criminal prosecutions. To support our Biologic product lines, we are a registered establishment with the FDA for the storage and distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Fraud, Abuse and False Claims
We are required to comply with federal and state laws relating to healthcare fraud and abuse. Such healthcare fraud and abuse laws apply to the relationships that we and our distributors have with healthcare professionals and entities (such as physicians and hospitals). The requirements of these laws are complex and subject to varying interpretations. If we fail to comply with these laws, we could be subject to federal or state government investigations, substantial fines, exclusion from future participation in government healthcare programs, and civil or criminal sanctions. Such sanctions and damages could adversely affect the economic viability of our Company.
Employees
Effective January 1, 2017, we engaged AmBio Staffing, LLC (“AmBio”) a Texas licensed Professional Employment Organization, (“PEO”) to provide us with payroll processing, employee benefit administration, and related human capital services. Our Chairman of the Board and President, Mark Brooks, owns and controls AmBio. As of March 26, 2018, AmBio supports approximately 74 full time equivalents (“FTE”). Of those 72 FTEs, 42 FTEs directly support us, 19 FTEs support the operations of other companies, and we share 13 FTEs with other companies.
Our business and an investment in our securities are subject to a variety of risks. The following risk factors describe some of the most significant events, facts, or circumstances that could have a material adverse effect upon our business, financial condition, results of operations, ability to implement our business plan, and the market price for our securities. Many of these events are outside of our control. If any of these events actually occur, our business, financial condition, or results of operations may be materially adversely affect, the trading price of our Common Stock could decline and investors in our Common Stock could lose all or part of their investment. We believe our Common Stock continues to be thinly traded and therefore, subject to significant volatility.
Risks Related to Our Business and Industry
If the statutes and regulations in our industry change, our business could be adversely affected.
In recent years the U.S. healthcare industry has undergone significant changes designed to improve patient safety, clinical outcomes, and increase access to medical care. These changes include the enactment and repeal of various healthcare related laws and regulation. Our operations and economic viability may be adversely affected by the changes in such regulations, including: (i) federal and state fraud and abuse laws; (ii) federal and state anti-kickback statutes; (iii) federal and state false claims laws; (iv) federal and state self-
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referral laws ; (v) state restrictions on fee splitting ; (vi) laws regarding the privacy and confidentiality of patient information ; and (vii) other laws and government regulations.
If there is a change in law, regulation, or administrative or judicial interpretations, we may have to change our business practices, or our existing business practices could be challenged as unlawful, which could have a material adverse effect on our business, financial condition, and results of operations.
U.S. and state governmental regulation could restrict our ability to sell the products.
Our business is subject to highly complex and evolving regulatory and licensing requirements that are subject to uncertainty, rapid change, differing interpretations, and rigorous regulatory enforcement. Failure to comply with such regulatory requirements may result in civil or criminal penalties including the loss of licenses or the exclusion from future participation in government healthcare programs. There can be no assurance that federal or state regulatory or enforcement authorities will not investigate or challenge our current or future activities under these laws. Any state or federal regulatory or enforcement review of our Company, regardless of the outcome, would be costly and time consuming. Additionally, we cannot predict the impact of any changes in these laws, whether these changes are retroactive or will affect our Company on a going-forward basis only. Any investigation or challenge could have a material adverse effect on our business, financial condition, and results of operations.
Our operating earnings are dependent on certain significant suppliers.
In the United States, we distribute products from nearly 46 suppliers and are dependent on these suppliers for the continuing supply of products. In 2017, purchases of product from our largest supplier accounted for approximately 22% of consolidated cost of revenues. We rely on suppliers to provide agreeable purchasing and delivery terms and performance incentives. Our ability to sustain adequate operating earnings has been, and will continue to be, dependent upon our ability to obtain favorable terms and incentives from suppliers, as well as suppliers’ continuing use of third-party distributors to sell and deliver their products. A change in terms by a significant supplier, or the decision of such a supplier to distribute its products directly to healthcare providers rather than through third-party distributors, could have a material adverse effect on our results of operations and financial condition. On January 30, 2018, we received notice from one of our largest suppliers, of their notice of termination of our distribution agreement, as more fully described in “Item 9B, Other Information”.
Product pricing is subject to regulatory control.
Routinely, the pricing and profitability of the products we sell are subject to control by third-party payors. The continuing efforts of governmental and other third-party payors to contain or reduce the cost of healthcare through various means may adversely affect our ability to successfully commercialize our products. We anticipate that there will continue to be federal and state proposals to implement similar governmental control, although it is unclear which proposals will ultimately become law, if any. Changes in prices, including any mandated pricing, could impact our revenues, profitability, and financial performance.
The FDA regulates the manufacturers and suppliers of the products we sell, market, and distribute, and regulatory compliance is costly and could contribute to delays in the availability of our products.
The manufacturers and suppliers of the products we sell, market, and distribute are subject to FDA regulation. These regulations govern the (i) manufacturing and processing of cellular and tissue products; (ii) introduction of new medical devices; (iii) observance of certain standards with respect to the design, manufacturing, testing, labeling, promotion, and sales of the devices; (iv) maintenance of certain records; (v) ability to track devices; (vi) reporting of potential product defects; (vii) importing and exporting of devices; and (viii) various other matters. Further, the manufacturers that create the products we market face an increasing amount of scrutiny and compliance costs as more states implement regulations governing medical devices, and biologics. These types of regulations could affect many of the products we market, impacting our revenues and profitability, results of operations, and working capital.
Future regulatory action remains uncertain.
We operate in a highly-regulated and evolving environment with rigorous regulatory enforcement. Any legal or regulatory action could be time-consuming and costly. If we or the manufacturers or distributors that supply our products fail to comply with all applicable laws, standards, and regulations, action by the FDA or other regulatory agencies could result in significant restrictions, including restrictions on the marketing or use of the products we sell or the withdrawal of the products we sell from the market. Any such restrictions or withdrawals could materially affect our business and operations.
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Our revenues will depend on ou r customers ’ continued receipt of adequate reimbursement from private insurers and government sponsored healthcare programs .
Political, economic, and regulatory influences are fundamentally changing the healthcare industry in the United States. The ability of hospitals to pay fees for our products partially depends on the extent to which reimbursement for the costs of such materials and related treatments will continue to be available from private health coverage insurers and other organizations. We may have difficulty gaining market acceptance for the products we sell if third-party payors do not provide adequate coverage and reimbursement to hospitals.
Major third-party payors of hospitals, such as private healthcare insurers, periodically revise their payment methodologies. We cannot predict these periodic revisions with certainty, and such revisions may result in stricter standards for reimbursement of hospital charges for certain specified products, potentially adversely impacting our business, results of operations, and financial conditions.
As a distributor, the FDA and similar state authorities require us to list and register certain products.
As a distributor and marketer of FDA-regulated products, we may be subject to independent requirements to register and list certain products. We may be required to obtain state licensure or certifications and may be subject to inspections, in addition to complying with derivative requirements applicable to the manufacturers of the products we market. Failure to comply with such applicable requirements could result in a wide variety of enforcement actions, ranging from warning letters to more severe sanctions, such as significant costly fines and civil penalties, operating restrictions, injunctions, and criminal prosecutions, all of which could adversely impact our business.
We operate our business in regions subject to natural disasters and other catastrophic events, and any disruption to our business resulting from natural disasters would adversely affect our revenue and results of operations.
We operate our business in regions subject to severe weather and natural disasters including hurricanes, floods, fires, earthquakes, and other catastrophic events. Any natural disaster could adversely affect our ability to conduct business and provide products and services to our customers, and the insurance we maintain may not be adequate to cover our losses resulting from any business interruption resulting from a natural disaster or other catastrophic event.
We depend on the knowledge and skills of our senior management and other key employees, and if we are unable to retain and motivate them or recruit additional qualified personnel, our business may suffer.
We benefit substantially from the leadership and performance of our senior management and certain key employees. For example, key members of our management have experience successfully scaling an early stage medical device company to achieve profitability. Our success will depend on our ability to retain our current management and key employees, and to attract and retain qualified personnel in the future. Competition for senior management and key employees in our industry is intense and we cannot guarantee that we will be able to retain our personnel or attract new, qualified personnel. This uncertainty may be especially true during periods in which we face challenges such as financial difficulties or a reduced stock price. The loss of the services of certain members of our senior management or key employees could prevent or delay the implementation and completion of our strategic objectives, or divert management’s attention to seeking qualified replacements. Each member of the senior management team and our key employees may terminate employment without notice and without cause or good reason. The members of our senior management are not subject to non-competition agreements. Accordingly, the adverse effect resulting from the loss of certain members of senior management could be compounded by our inability to prevent them from competing with us.
Pricing pressure to contain costs and reduce prices could have a negative impact on our future operations.
Pricing pressure has increased in our industry primarily due to continued consolidation among healthcare providers, trends toward managed care, the recent shift towards increased government involvement of healthcare costs, and laws and regulations relating to reimbursement and pricing. Pricing pressure, reductions in reimbursement levels or coverage, or other cost containment measures could unfavorably impact our business, future operating results and financial condition.
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We have significant concentration in and dependence on customers and certain healthcare provider customers.
In 2017, our top two customers represented approximately 37% of our consolidated net revenues. If an existing contract with one of these two customers expires without being replaced or the customer or certain healthcare provider customer terminates the contract prior to its expiration, we could lose that customer relationship, which could adversely impact our business, future operating results, and financial condition.
To grow revenues and profitability from certain products, we must expand our relationships with distributors and independent sales representatives, whom we do not control.
We derive significant revenues through our relationships with distributors and independent sales representatives. If such a relationship terminated for any reason, it could materially and adversely affect our ability to generate revenues and profits. Because the independent distributor often controls the customer relationships within its territory, there is a risk that if our relationship with the distributor ends, we could lose our relationship with our ultimate customer.
We intend to obtain the assistance of additional distributors and independent sales representatives to continue our sales growth with respect to certain categories of our products. Our success partially depends on our ability to retain and motivate our distributors, independent sales agencies, and their representatives to sell our products in certain territories. However, such parties may not be successful in implementing our strategies and marketing plans. Some of our distributors and independent sales agencies do not sell our products exclusively and may offer competing products from other companies. Our distributors and independent sales agencies may terminate their contracts with us, may devote insufficient sales efforts to our products, or may focus their sales efforts on other products that produce greater commissions for them, which could adversely affect our operations and operating results. We also may not be able to find additional distributors and independent sales representatives who will agree to market or distribute our products on commercially reasonable terms, if at all. If we are unable to establish new distribution and independent sales representative relationships or renew current distribution and sales agency agreements on commercially acceptable terms, our business, financial condition and results of operations could be materially and adversely affected.
Our growth and profitability will depend in large part upon the effectiveness of our marketing strategies and expenditures.
Our future growth and profitability will partially depend upon our marketing performance and appropriate cost structure, including our ability to:
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create greater awareness of the products we sell and the excellent quality control and customer service of our Company; |
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identify and utilize the most effective sales representatives who understand the advantages of our products and who can effectively communicate that to physicians; and |
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effectively manage marketing and administrative expenditures. |
Ineffective sales representatives, promotional efforts, and management of working capital could adversely affect our future results of operations and financial condition.
We may be subject to future product liability litigation that could be costly, and we may not carry adequate product liability insurance coverage.
We maintain product liability insurance, however there can be no assurance that such coverage is sufficient to cover all product liabilities that we may incur. We are not currently subject to any product liability proceedings, and we have no reserves for product liability disbursements. However, we may incur material liabilities relating to product liability claims in the future, including product liability claims arising out of the usage and delivery of our products. Should we incur product-related liabilities exceeding our insurance coverage, we would be required to use available cash or raise additional cash to cover such liabilities.
10
Uncertainty in future changes to tax legislation, regulatory reform , or policies could have a material adverse effec t on our business.
Tax laws, regulations, and policies in various jurisdictions may be subject to significant change due to economic, political and other conditions. The recently enacted U.S. tax reform legislation referred to the Tax Cuts and Jobs Act of 2017 (the “U.S. Tax Reform”), significantly changes how the U.S. taxes corporations. The U.S. Treasury Department, the Internal Revenue Service (the “IRS”), and other standard-setting bodies could interpret or issue guidance on how provisions of the U.S. Tax Reform will be applied or otherwise administered that is different from our interpretation. As we complete our analysis of the U.S. Tax Reform, collect and prepare necessary data, and interpret any additional guidance, we may adjust the provisional amounts that we have recorded, which may materially impact our provision for income taxes in the period in which the adjustments are made. In addition, state or local jurisdictions may enact tax laws in response to the U.S. Tax Reform that could result in further changes to taxation and materially affect our financial position and results of operations.
Our executive management team, including our Chief Executive Officer, Chairman of the Board and President, and Chief Financial Officer may dedicate inadequate time and attention to our Company.
Members of our executive management team, including our Chief Executive Officer, our Chairman of the Board and President, and our Chief Financial Officer, hold leadership roles in other companies and related companies with which we do business. Each of these individuals may allocate their time between our affairs and the affairs of other companies. This situation presents the potential for conflicts of interest in determining the respective percentages of the time that these individuals devote to our affairs and the affairs of other companies. In addition, if the affairs of the other companies require the members of our management team to devote more substantial amounts of their time to those affairs in the future, their ability to devote sufficient time to our affairs may be limited and could negatively impact our business.
Future business combinations or acquisitions may be difficult to integrate, which could cause us to shift our attention away from our primary business and its operations.
We may pursue various business combinations with other companies or strategic acquisitions of complementary businesses, product lines, or technologies. There can be no assurance that such acquisitions will be available at all or on terms acceptable to us. These transactions may require additional capital which may increase our indebtedness or outstanding shares, resulting in a dilution to our stockholders or a reduction in working capital. The inability to obtain such future capital may inhibit our growth and operating results. Integration of acquisitions or additional products can be costly, time-consuming, and complicated which could significantly impact operating results. Furthermore, the integration of any acquisition may disproportionally divert management’s time and resources from our primary business and its operations. We may sell some or all of our product lines to other companies or we may agree to merge with another company. There can be no assurance that future transactions will ultimately benefit our Company. If we face difficulty integrating future acquisitions or if our management team’s attention is diverted, our future results of operations may negatively impact our business, results of operations, and financial condition.
General economic conditions may adversely affect demand for our products and services.
Poor or deteriorating economic conditions in the United States could adversely affect the demand for healthcare services and consequently, the demand for our products and services. Poor economic conditions also could lead our suppliers to offer less favorable terms of purchase to distributors, which would negatively affect our profitability. These and other possible consequences of financial and economic decline could have material adverse effect on our business, results of operations, and financial condition.
Risks Related to Ownership of Our Common Stock
Because the market for our Common Stock is limited, persons who purchase our Common Stock may not be able to resell their shares at or above the purchase price they paid.
Our Common Stock trades on the Over-the-Counter markets (“OTC Markets”), which are not highly liquid securities markets, and is designated as OTC Pink, Current Information Tier. With some limited exceptions, there has not been an active public market for our Common Stock. We cannot provide an assurance that an active public market for our Common Stock will develop or be sustained in the future. If an active market for our Common Stock does not develop or is not sustained, the price may decline and our stockholders may lose their investment in our Common Stock.
11
Historically, the market price for our Common Stock has been highly volatile . From time to time , the market has experienced significant price and volume fluctuations , which are unrelated to our operating performance. Fluctuations in the trading price or liquidity of our Common Stock may reduce the value of an investment in our Common Stock .
Factors that may have a significant impact on the market price and marketability of our Common Stock include:
|
• |
changes in national health care policies and practices; |
|
• |
third-party reimbursement policies; |
|
• |
adverse legislation, including changes in governmental regulation; |
|
• |
litigation and government proceedings; |
|
• |
uncertainty related to future legislation, regulatory reforms, or policy changes, including the impact of the U.S. Tax Reform; |
|
• |
announcements of technological innovations or new commercial products by our collaborative partners, our present competitors, or potential competitors; |
|
• |
developments in our relationships with employees, suppliers, or collaborative partners; |
|
• |
developments or disputes concerning patent or other proprietary rights; |
|
• |
acquisitions or divestitures; |
|
• |
our quarterly operating results; |
|
• |
short selling; |
|
• |
changes in securities analysts’ recommendations; |
|
• |
economic and other external factors; and |
|
• |
general market conditions. |
In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has frequently been instituted. These lawsuits often seek unspecified damages, and as with any litigation proceeding, we cannot predict with certainty the eventual outcome of pending litigation. Furthermore, we may have to incur substantial expenses related to any securities class action lawsuits and our management’s attention and resources could shift away from operating our business to responding to any such litigation. We maintain insurance to cover these types of risks for our Company, our directors, and our officers. Our insurance coverage and policies are subject to high deductibles to reduce premium expenses, and there is no guarantee that our insurance will cover any specific claim that we currently face or may face in the future, or that our insurance will be adequate to cover all potential liabilities and damages or that we will have sufficient working capital or funds.
Our current management can exert significant influence over our Company and make decisions that are not in the best interests of all stockholders.
As a group, our executive officers and directors beneficially own approximately 90.4% of our outstanding shares of Common Stock. Because of this ownership, these stockholders can assert significant influence over all matters requiring stockholder approval, including the election and removal of directors and any change-in-control. Such concentration of ownership of our outstanding Common Stock could delay or prevent a change-in-control, or otherwise discourage or prevent a potential acquirer from attempting to obtain control of our Company, possibly negatively affecting the market price of our Common Stock. This ownership could also prevent our stockholders from realizing a premium over the market prices for their shares of Common Stock. Moreover, the interests of executive officers and directors may not always coincide with the interests of our Company or the interests of other stockholders causing us to enter into transactions or agreements that we would not otherwise consider.
We cannot be certain that our internal controls over financial reporting and procedures are sufficient. Although we are taking significant remedial measures (as explained elsewhere in this 2017 Annual Report), this uncertainty could have a material adverse effect on our investors’ confidence in our reported financial information. There is no guarantee that our internal controls over financial reporting and procedures will not fail in the future.
Effective internal controls over financial reporting and disclosure controls and procedures are necessary to providing reliable financial reports and to detect and prevent fraud. Prior to the Change-in-Control Date, we deemed our internal controls and procedures inadequate. The significant assessment and remediation measures we have taken may not be sufficient to maintain investors’
12
confidence or a loss of reputation, and may result in an adverse impact to our financial position and results of operations . Our disclosure controls and internal controls over financial reporting may not prevent al l errors or all instances of fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance s that the objectives of the control system will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our business have been detected. These inherent limitations include the realities that judgments in decision-making can be faul ty, and that breakdowns can occur because of simple error s or mistake s . Individual acts can also circumvent these controls through collusion of two or more people or through management ’s override of the controls. The design of any system of controls is bas ed in part upon certain assumptions about the likelihood of future events, and any design may not succeed in achieving its stated goals under all potential conditions. Over time, controls may become inadequate because of changes in conditions or deteriorat ion in the degree of compliance with policies or procedures. Because of the inherent limitation of a cost-effective control system, misstatements due to error or fraud may have occur red and may not have be en detected. A failure in any of our internal controls and procedures may result in (i) enforcement actions by the SEC or other government al or regulatory bodies ; (ii) litigation ; (iii) loss of reputation ; (iv) loss of investor confidence ; (v) an inability to acquire ca pital ; or (vi) other material adverse effects on our Company .
Because we are subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our Common Stock which adversely affects the liquidity and market price of our Common Stock.
The SEC has adopted regulations which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. The market price of our Common Stock on the OTC Markets has been substantially less than $5.00 per share and, therefore, we are currently considered a “penny stock” according to SEC rules. This designation requires any broker-dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules limit the ability of broker- dealers to solicit purchases of our Common Stock and, therefore, reduces the liquidity of the public market for our Common Stock.
We believe a growing number of broker-dealers do not permit investors to resell shares of penny stocks, like our Common Stock. This position may have had and may continue to have a depressive effect upon the price of our Common Stock, which could negatively affect the performance of your investment in us.
Under our charter documents and Delaware law, we could issue “blank check” preferred stock without stockholder approval, which would dilute our then current stockholders’ interests and impair such stockholders’ voting rights, discouraging a takeover that our stockholders may consider favorable.
Our certificate of incorporation provides that we may authorize and issue up to 20,000,000 shares of “blank check” preferred stock with designations, rights, and preferences as may be determined from time to time by our Board. Our Board is empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting, or other rights, which could dilute the interest of or impair the voting power of our holders of Common Stock. The issuance of a series of preferred stock could be used as a method of discouraging, delaying, or preventing a change in control. For example, it would be possible for our Board to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of our Company.
If our Common Stock becomes subject to a “chill” or a “freeze” imposed by the Depository Trust Company (“DTC”) our stockholders’ ability to sell shares may be limited.
The DTC acts as a depository or nominee for street name shares or stock that investors deposit with their brokers. Although through DTC our Common Stock is eligible for electronic settlement, historically DTC has imposed a chill or freeze on the deposit, withdrawal, and transfer of common stock of issuers whose common stock trades on the OTC Markets. Depending on the type of restriction, it can prevent our stockholders from buying or selling our shares of Common Stock and prevent us from raising money. A chill or freeze may remain imposed on a security for a few days or an extended period. While we have no reason to believe a chill or freeze will be imposed against our Common Stock, if DTC did so, our stockholders’ ability to sell their shares would be limited.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
None.
13
We lease an approximately 11,500 square-foot space as our principal executive office, located at 1565 North Central Expressway, Suite 220, Richardson, Texas 75080 from 1565 North Central Expressway, LP (“NCE, LP”), a real estate investment company that is owned and controlled by Mark W. Brooks, our Chairman of the Board and President. The CPM lease with NCE, LP was effective January 1, 2013, and the Fuse lease with NCE, LP was effective July 14, 2017. Both leases terminated December 31, 2017, with month-to-month renewals. Our leased property does not have material costs of complying with environmental laws. We believe our present business property is adequate and suitable to support our mid-term strategies and initiatives for growth. We are in the process of renegotiating a lease renewal, but we believe there is a large supply of comparable commercial property available in the general area that we would be able to lease at comparable rates.
On January 27, 2014, M. Richard Cutler and Cutler Law Group, P.C. (the “Plaintiffs”) filed a complaint in the District Court of Harris County, Texas, 2014-03355, against Fuse, Alan Meeker, Rusty Shelton, Jonathan Brown, Robert H. Donehew and Golf Rounds.com, Inc. (the “Defendants”). On April 21, 2014, the complaint was dismissed for “want of prosecution.”
On September 18, 2015, Plaintiffs refiled a complaint in the District Court of Harris County, Texas, Cause No. 2015-55652 and added PH Squared, LLC as an additional Plaintiff, as more fully described in “Legal Matters” included in Note 7 in our audited financial statements contained in this 2017 Annual Report, which is herein incorporated by reference. We anticipate incurring approximately $50,000 of additional legal fees regarding this matter. The trial date for the above matter was scheduled for May 1, 2017, but it was moved to July 24, 2017, to allow for additional discovery.
During April 2017, one of the named individuals in the complaint filed for bankruptcy protection. There is currently no trial date set.
Our management continues to believe that the lawsuit is completely without merit and will vigorously contest it to protect our interests.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
14
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Our Common Stock trades and is quoted on the OTC Markets designated as OTC Pink, Current Information Tier, under the trading symbol OTCMKTS:FZMD. To date, the trading market for our Common Stock has been extremely limited and sporadic.
Below is a table indicating the range of high and low bid information for our Common Stock as reported by the OTC Markets interdealer quotation system (“OTC Bulletin Board”) for the periods listed. Bid prices represent interdealer prices and do not include retail mark-ups, retail mark-downs, or any commission to a broker-dealer. In addition, these prices do not necessarily reflect actual transactions.
|
|
High |
|
|
Low |
|
||
Fiscal 2017 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
0.95 |
|
|
$ |
0.16 |
|
Second Quarter |
|
|
0.32 |
|
|
|
0.32 |
|
Third Quarter |
|
|
2.70 |
|
|
|
0.30 |
|
Fourth Quarter |
|
|
4.65 |
|
|
|
1.50 |
|
Fiscal 2016 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
0.19 |
|
|
$ |
0.15 |
|
Second Quarter |
|
|
0.15 |
|
|
|
0.11 |
|
Third Quarter |
|
|
0.15 |
|
|
|
0.12 |
|
Fourth Quarter |
|
|
0.16 |
|
|
|
0.11 |
|
Holders of Record
As of March 26, 2018, there were 350 account holders of record of our Common Stock.
Dividends
We have not paid or declared any dividends on our Common Stock during the past two fiscal years and we do not intend to pay any dividends on our Common Stock for the foreseeable future.
ITEM 6. SELECTED FINANCIAL INFORMATION.
As a smaller reporting company, as defined in Rule 12b-2 of the Exchange Act, we are not required to provide the information required by this item.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion highlights our results of operations and the principal factors that have affected our consolidated financial condition, our liquidity and our capital resources for the periods described. The discussion also provides information that our management believes is relevant for an assessment and understanding of our consolidated financial condition and results of operations presented herein. The following discussion and analysis are based on our audited financial statements contained in this 2017 Annual Report, which have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Please read the discussion and analysis together with such financial statements and the related notes therein.
Explanatory Note
As more fully described in “Item 1. Business, Change-in-Control,” “Item 1. Business, CPM Acquisition,” and elsewhere in this 2017 Annual Report, the change-in-control over a majority of our issued and outstanding voting Common Stock resulted in new executive leadership during 2016. The CPM Acquisition occurred during December 2017 and reflects CPM as the reporting entity for 2017 and 2016. Effective on the Change-in-Control Date, Fuse consolidated with CPM.
15
We are a national distributor of medical devices, and we provide a broad portfolio of Orthopedic Implants including: (i) internal and external fixation products; (ii) upper and lower extremity plating and total joint reconstruction implants; (iii) soft tissue fixation and augmentation for sports medicine procedures; and (iv) spinal implants for trauma, degenerative disc disease, and deformity indications. All of our medical devices are approved by the FDA for sale in the United States.
To support orthopedic surgeries, we offer Biologics that include: (a) osteo Biologics (cellular bone allografts and synthetics); (b) tendons and tissues (ligaments, tendons, and dermal graft); (c) regenerative tissues (amniotic membrane (dry), amniotic membrane (injectable), and amniotic fluids (frozen)); and (d) autologous products (platelet - rich plasma, and bone marrow aspirate concentration systems). All of our Biologics suppliers are licensed tissue banks accredited by the AATB.
Medical device distributorships such as ours typically experience greater revenue, and volume, as a percentage of revenue, between the last two calendar quarters compared to the first two calendar quarters of the year because indirect and overhead costs decline. We believe that this change is due partially to the result of patient annual healthcare deductibles being met during the last two quarters of the calendar year compared to the first two quarters of the calendar year, which is driven, in part, by elective surgeries.
Pricing pressure has increased in our industry due to continued consolidation among healthcare providers, increased trends toward managed care, increased shift towards increased government involvement of healthcare costs, and enacted or amended laws and regulations that relate to reimbursement and pricing. Pricing pressure, reductions in reimbursement levels or coverage, or other cost containment measures could unfavorably impact our business, future operating results and financial condition.
Our results-driven leadership has the following strategic objectives: (i) build a scalable cost-effective infrastructure; (ii) broaden and expand product offerings; (iii) migrate sales model from fixed cost to variable cost; and (iv) acquire strategic independent distributors. To achieve a scalable cost-effective infrastructure, we are instituting uniform processes, controls, and automation. To broaden and expand product offerings, we continuously review and expand our product lines to ensure we offer the highest-quality and most cost effective comprehensive selection of Orthopedic Implants and Biologics, allowing us to meet our customers’ needs while continuing to grow our existing customer base. To successfully migrate sales models from fixed cost to variable cost, we reduced the salary-based sales force and shifted to variable compensation packages. Lastly, to acquire strategic independent distributors, we are replacing legacy sales management with independent distributors who have existing books of business and industry experience from networking, attending conferences, leveraging resources, and industry knowledge.
During the year-ended 2017, we have successfully executed the following milestones: (a) expanded product offerings to over 40 manufacturers; (b) acquired CPM during December 2017 as more fully described in this “Item 1. Business, Change-in-Control ” and “Item 1. Business, CPM Acquisition ” in this 2017 Annual Report; (c) integrated the operations of CPM with our supply-chain, finance, sales support, and other related functions, providing an improved service platform that supports scalability and strengthens our internal controls; (d) outsourced our payroll and human capital functions to AmBio, which is controlled by Mark W. Brooks, our Chairman of the Board and President; (e) replaced legacy sales management with established independent contractors who contribute existing books of business with strong revenue and in-depth industry experience to provide us with improved cost effectiveness; (f) terminated or renegotiated fixed costs contracts with third-party service providers; (g) instituted formalized initiatives to identify strategic acquisition targets, vertical supply chain integration opportunities, and new, high-value vendor relationships.
We believe our comprehensive selection of Orthopedic Implants and Biologics products will prove to be pivotal in our ability to acquire new customers and increase revenues and profitability. We expect to offer compensation and other valuable long-term incentives, like equity awards, to key distributors, executive leadership, and key employees as we continue to expand our strategic partnerships and network arrangements.
Tax Cuts and Jobs Act
The recent U.S. Tax Reform lowers the statutory tax rate on U.S. earnings, taxes historic foreign earnings at a reduced rate of tax, establishes a territorial tax system and enacts new taxes associated with global operations. As a result of the enactment of U.S. tax reform, we are currently evaluating the U.S. Tax Reform impact to our financial condition and results of operations. We expect to realize the benefits of lower tax rates.
Inflation
The effect of inflation, as measured by fluctuations in the U.S. Consumer Price Index, has not had a material impact on our Financial Statements during the periods presented.
Results of Operations
16
The following table sets forth certain financia l information from our consolidated statements of operations along with a percentage of net revenue and should be read i n conjunction with the consolidated financial statements and related notes included in this report.
|
Year Ended December 31, |
|
||||||||||
|
2017 |
|
% |
|
2016 |
|
% |
|
||||
Net revenue |
$ |
26,407,206 |
|
100% |
|
$ |
25,666,650 |
|
100% |
|
||
Cost of revenue |
|
14,582,416 |
|
55% |
|
|
11,256,887 |
|
44% |
|
||
Gross profit |
|
11,824,790 |
|
45% |
|
|
14,409,763 |
|
56% |
|
||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general, administrative, and other |
|
5,356,475 |
|
20% |
|
|
4,170,835 |
|
16% |
|
||
Commissions |
|
5,641,122 |
|
21% |
|
|
7,056,430 |
|
27% |
|
||
Gain on disposal of property and equipment |
|
(5,367 |
) |
0% |
|
|
- |
|
0% |
|
||
Depreciation |
|
14,521 |
|
0% |
|
|
19,091 |
|
0% |
|
||
Total operating expenses |
|
11,006,751 |
|
42% |
|
|
11,246,356 |
|
44% |
|
||
Operating income |
|
818,039 |
|
3% |
|
|
3,163,407 |
|
12% |
|
||
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(161,669 |
) |
(1%) |
|
|
(146,921 |
) |
(1%) |
|
||
Extinguishment of debt |
|
43,308 |
|
0% |
|
|
- |
|
0% |
|
||
Net income |
$ |
699,678 |
|
3% |
|
$ |
3,016,486 |
|
12% |
|
Year Ended December 31, 2017 Compared to Year Ended December 31, 2016
Net Revenue
For the year ended December 31, 2017, our net revenue was $26,407,206, compared to $25,666,650 for the year ended December 31, 2016, an increase of $740,556, or approximately 3%. The increase in net revenue is primarily a result of an approximate 10% increase in medical cases in which our products are used (“Cases,” and each a “Case”) and an approximate 6% decline in net revenue per case. Pricing pressure has increased in our industry primarily due to continued consolidation among healthcare providers, trends toward managed care, the recent shift towards increased government involvement of healthcare costs, and laws and regulations relating to reimbursement and pricing. Pricing pressure, reductions in reimbursement levels or coverage, or other cost containment measures could unfavorably impact our business, future operating results and financial condition. Continued pricing pressures will require increased case volume to maintain gross profit levels.
We added 57 new customers and retained 88 customers, offset, in part, by 87 inactive customers for 2017 as compared to 2016.
The destruction caused by Hurricane Harvey impacted several of our customer hospitals and surgical facilities in the southeast Texas regions and parts of Louisiana. While we are unable to quantify the exact impact to our results of operations and financial position we believe this disaster adversely impacted our net revenues and results of operations.
Cost of Revenue
For the year ended December 31, 2017, our cost of revenue was $14,582,416, compared to $11,256,887 for the year ended December 31, 2016, an increase of $3,325,529 or 30%. As a percentage of revenue, cost of revenue was approximately 55% and 44% for the year ended December 31, 2017 and 2016, respectively. The increase as a percentage of revenue is approximately 11% and is primarily the result of an approximate 3% increase in lost, damaged, or and expired inventory, and the 10% increase in case volume. This increase in lost, damaged, or expired inventory and our write downs will require our Company to increase case volume.
Gross Profit
For the year ended December 31, 2017, our gross profit was $11,824,790 compared to $14,409,763 for the year ended December 31, 2016, representing a decrease of $2,584,973 or 18%. As a percentage of revenue, gross profit was approximately 45% and 56% for the year ended December 31, 2017, and 2016, respectively. The decrease as a percentage of revenue is approximately 11% and is primarily due to an approximate 6% decline in net revenue per case, an approximate 3% increase in lost, damaged or and expired inventory, and offset, in part, by a 10% increase in case volume.
17
Selling, General, Administrative and Other Expense
For the year ended December 31, 2017, our selling, general, administrative, and other expense increased to $5,356,475, from $4,170,835 for the year ended December 31, 2016, an increase of $1,185,640, or 28%. As a percentage of net revenue, selling, general, administrative, and other expense was approximately 20% and 16% for the year ended December 31, 2017, and 2016, respectively. The increase as a percentage of revenue is approximately 5% and is primarily the result of an increase as a percentage of net revenue of approximately 4% in professional fees related to our acquisition and integration of CPM, an approximate 1% increase in leased staffing of FTEs, offset, in part, by an approximate 1% decrease bad debt expense.
Commission Expense
For the year ended December 31, 2017, our commission expense decreased to $5,641,122 from $7,056,430 for the year ended December 31, 2016, a decrease of $1,415,308, or approximately 20%. As a percentage of net revenue, commission expenses were approximately 21% and 27% for the year ended December 31, 2017, and 2016, respectively. During 2017, we began to redesign and update our independent sales representative commission agreements to increase our profitability, on a customer basis, and improve our cost effectiveness.
Depreciation Expense
For the year ended December 31, 2017, our depreciation expense declined to $14,521, from $19,091 for the year ended December 31, 2016, a decrease of $4,570 or approximately 24%. The decrease is primarily related a reduction in fixed assets.
Interest Expense
For the year ended December 31, 2017, our interest expense increased to $161,669 from $146,921 for the year ended December 31, 2016, an increase of $14,748, or approximately 10%. The increase is primarily driven by an approximate $18,099 increase related to increased LIBOR interest rates, an increase of $26,507 in connection with accrued interest on notes payable – to related parties (convertible notes to NC 143 and RMI), offset, in part, by $16,763 reduction as a result of reduced average borrowings and by a $13,095 decrease in connection with the beneficial ownership discount amortization.
Extinguishment of Debt
For the year ended December 31, 2017, we recorded $43,308, for extinguishment of debt related to long-aged outstanding payables. For the year ended December 31, 2016 we did not have any extinguishment of debt.
Net Income
For the year ended December 31, 2017, our net income was $699,678, compared to net income of $3,016,486 for the year ended December 31, 2016, representing a decline of $2,316,808, or approximately 77%. As a percentage of revenue, net income was approximately 3% and 12% for the year-ended December 31, 2017, and 2016, respectively. The decrease as a percentage of revenues is approximately 9% and is primarily attributed to 11% decrease in gross profit, a 5% increase in selling, general, administrative and other expenses, offset, in part, by a 6% reduction in commission expense and a 1% reduction in depreciation expense and extinguishment of debt.
Liquidity and Capital Resources
A summary of our cash flows is as follows:
|
|
Year-ended December 31, |
|
|||||
|
|
2017 |
|
|
2016 |
|
||
Net cash provided by operating activities |
|
$ |
1,604,536 |
|
|
$ |
2,790,338 |
|
Net cash (used in) provided by investing activities |
|
|
(11,602 |
) |
|
|
655,390 |
|
Net cash used in financing activities |
|
|
(1,566,666 |
) |
|
|
(2,930,906 |
) |
Net increase in cash and cash equivalents |
|
$ |
26,268 |
|
|
$ |
514,822 |
|
18
T o facilitate our strategic growth plans, on December 29, 2017, Fuse entered into , along with CPM, a $5,000,000 revolving line of credit (“RLOC”) with ZB, N.A. (d/b/a Amegy Bank) , to f acilitate the CPM Acquisition and the integration of the two companies as disclosed as Exhibit 10.1 in our Current Report on Form 8-K, filed with the SEC on January 11, 2018, and herein incorporated by reference. Mark W. Brooks, our Chairman of the Board and President, personally guarantees fifty present (50%) of the outstanding RLOC amount . Further , the RLOC will support our strategic growth initiatives and day-to-day working capital needs.
With the RLOC maturing on November 2, 2018, we are currently evaluating alternatives to the RLOC, including, but not limited to a renewal of the current credit facility, an increase in the credit facility availability, a new credit facility, or a newly structured facility. We expect our management team will provide our Board with a recommendation by the end of the second quarter of 2018.
Net Cash Provided by Operating Activities
Our net cash provided by operating activities during the year ended December 31, 2017, resulted primarily from net income of $699,678, $2,022,723 decrease in inventories, net $178,477 increase in accounts payable, $3,822 security deposit, $7,607 non-cash adjustments, offset, in part, by $1,236,5278 reduction in accrued expenses, $62,096 increase in accounts receivable, and an increase of $9,448 in prepaid expenses and other current assets.
Our net cash provided by operating activities during the year ended December 31, 2016, resulted primarily from net income of $3,016,486, a $995,785 decline in accounts receivable, $32,185 non-cash adjustments, and $107 reduction in prepaid expenses and other current assets, offset in part, by $1,313,409 reduction in accounts payable, and a $139,993 increase in inventories.
Net Cash (Used in) Provided by Investing Activities
Our net cash used in investing activities for the year ended December 31, 2017, primarily related to $20,334 for the purchase of property and equipment, offset in part by $8,732 insurance settlement proceeds.
Our net cash provided by investing activities for the year ended December 31, 2016, related to proceeds from our December change-in-control of $655,390.
Net Cash Used in Financing Activities
Our net cash used in financing activities during the year ended December 31, 2017, primarily resulted from $1,949,714 in member distributions (successor), offset, in part, by $273,044 of member contributions (successor) and net borrowings from our RLOC.
Our net cash used in financing activities during the year ended December 31, 2016, primarily resulted from $ 2,395,606 in member distributions (successor), offset, in part, by $375,210 of member contributions (successor) and $910,5100 in net payment on our RLOC.
Liquidity
As a national distributor of medical devices, our primary sources and uses of liquidity are generated by our operations, our RLOC, commissions, payroll and human capital, and professional fees.
Our strategic growth plan provides for capital investment to upgrade our financial systems, support our infrastructure, and increase our support staff. This investment is deemed essential to support our growth and expansion objectives. We estimate the range of this type of investment to be approximately $400,000 to $650,000, and anticipate the investment to occur in the second half of calendar year 2018. Our projections for calendar years 2018, 2019, and 2020, include expansion opportunities through carefully evaluated and integrated acquisitions, and our five-year projections include the investment in our independent contractor sales team, including focused training, development, and accountability.
At December 31, 2017, our current assets exceeded our current liabilities by $10,050,211 (our “Working Capital”), which included $804,715 in cash and cash equivalents. As of March 26, 2018, we had approximately $770,000 in available cash. We maintain our cash with large financial institutions. We believe our operations as well as our working capital and revolving line of credit will enable us to support our mid-term growth strategies.
During 2016, we received proceeds of: (i) $720,000 from the sale of our Common Stock in private offerings; (ii) $150,000 in aggregate from the issuance of Notes to entities controlled by the Investors; and (iii) $91,533 of capital contributions resulting from the transfer of inventory to CPM, as described in Item 13 “Certain Relationships and Related Transactions, And Director Independence” below and in our Current Report on Form 8-K, filed with the SEC on December 23, 2016.
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We have no off-balance sheet arrangements.
Related Party Transactions
Since December of 2016, we have been controlled by the Investors, who are our two primary stockholders. On the Change-in-Control Date, we entered into the Stock Purchase Agreement by and between the Investors and our Company, pursuant to which the Investors received the Investor Shares, effective as of the Change-in-Control Date. For more details, please see “Item 1. Business” of this 2017 Annual Report.
The closing of the Stock Purchase Agreement resulted in a change-in-control of our Company whereby the Investors beneficially acquired approximately 61.4% of our Common Stock issued and outstanding immediately after the Change-in-Control Date. Mark W. Brooks became our Chairman of the Board and Christopher C. Reeg became our Chief Executive Officer, as described in our Current Report on Form 8-K, filed with the SEC on December 23, 2016, which is herein incorporated by reference.
CPM Acquisition
On December 15, 2017, we entered into an agreement with NC 143 pursuant to which we would purchase all of the outstanding membership interests of CPM as disclosed in the CPM Acquisition Agreement, disclosed in our Current Report on Form 8-K, dated December 19, 2017, which is herein incorporated by reference.
On December 29, 2017, we completed the previously-announced CPM Acquisition, effective as of the Effective Date. We issued 50 million shares of our Common Stock in exchange for 100% of the outstanding membership interests of CPM, at an agreed-upon value of $0.20 per share of Common Stock, as disclosed in our Current Report on Form 8-K, filed January 5, 2018, and amended by our Current Report on Form 8-K/A, dated March 12, 2018, which are both herein incorporated by reference.
On the Effective Date and following the closing of the CPM Acquisition, NC 143 and RMI beneficially held approximately 90.4% of our Common Stock outstanding.
In the CPM Acquisition, Fuse was the legal acquirer and, for accounting purposes, CPM was deemed to have acquired Fuse. As a result, this 2017 Annual Report reflects CPM as the reporting entity for 2017 and 2016 and is consolidated with Fuse from, and effective, on the Change-in-Control Date.
Lease with 1565 North Central Expressway, LP
As disclosed in “Item 2. Properties” in this 2017 Annual Report, we lease an approximately 11,500 square-foot space as our principal executive office from NCE, LP, a real estate investment company that is owned and controlled by Mark W. Brooks, our Chairman of the Board and President. The CPM lease was effective January 1, 2013, and the Fuse lease was effective July 14, 2017. These leases terminated December 31, 2017, with month-to-month renewals, but we are in the process of renegotiating a lease renewal.
AmBio Contract
As disclosed in “Item 1. Business” in this 2017 Annual Report, AmBio provides us with payroll processing, employee benefit administration, and related human capital services to us effective January 1, 2017. Our Chairman of the Board and President, Mark Brooks, owns and controls AmBio. As of December 31, 2017, and 2016, we had balances due to AmBio of approximately $112,000. As of December 31, 2017, approximately $162,000 of fees were paid to AmBio for its services and are reflected with in selling, general, and administrative expenses on the accompanying consolidated statements of operations.
Operations
We have entered into various related party transactions with entities that are owned by or affiliated with our executive officers and members of our Board. The transactions included sales, purchases, commissions paid for services, and revenues related to services provided to the related party.
MedUSA Group, LLC
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MedUSA Group, LLC (“MedUSA”) is a sub-distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President, and Christopher C. Reeg, our Chief Executive Officer and Secretary .
During the years ended December 31, 2017, we had net sales of approximately $5,054,000 to MedUSA for products used in surgical cases.
During the years ended December 31, 2017, we incurred commission expense of approximately $962,000 to MedUSA for services provided to us in surgical cases.
As of December 31, 2017, we had balances due from MedUSA of approximately $1,684,000 included in accounts receivable on the accompanying consolidated balance sheets.
Texas Overlord, LLC
Texas Overlord, LLC (“Overlord”) is an investment holding company owned and controlled by Mark W. Brooks, our Chairman of the Board and President.
During the years ended December 31, 2017, we had net sales of approximately $1,953,000 to Overlord for product used in surgical cases.
During the years ended December 31, 2017, we incurred commission expense of approximately $101,000 respectively, to Overlord for services provided to us in surgical cases.
As of December 31, 2017, we had balances due from Overlord of approximately $444,000 included in accounts receivable on the accompanying consolidated balance sheets.
N.B.M.J., Inc.
N.B.M.J., Inc. (“NBMJ”) is a Durable Medical Equipment (“DME”) distributor and a wound care distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President.
During the years ended December 31, 2017, we had net sales of approximately $162,000 to NBMJ for product used in surgical cases.
During the years ended December 31, 2017 we incurred commission expense of approximately $0.00 to NBMJ for services provided to us in surgical cases.
Palm Springs Partners d/b/a Maxim Surgical, LLC
Palm Springs Partners d/b/a Maxim Surgical, LLC (“Maxim”) is a manufacturer/distributor owned and controlled by Christopher C. Reeg, our Chief Executive Officer and Secretary, and Mark W. Brooks, our Chairman of the Board and President.
During the year ending December 31, 2017, we had net sales of approximately $202,000 to Maxim for product used in surgical cases.
During the year ending December 31, 2017, we purchased approximately $468,000 from Maxim.
As of December 31, 2017, we had a balance due from Maxim of approximately $50,000, included in accounts receivable on the accompanying consolidated balance sheets. As of December 31, 2017, we had a balance due to Maxim of approximately $93,000, included in accounts payable on the accompanying consolidated balance sheets.
Sintu, LLC
Sintu, LLC (“Sintu”) is a sub-distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President. During the year ended December 31, 2017, we incurred commission expense of approximately $1,114,000 to Sintu for services provided in surgical cases.
Critical Accounting Policies and Estimates
The preparation of financial statements and related disclosures in conformity with GAAP, requires our management to make judgments, assumptions and estimates that affect the amounts of revenue, expenses, income, assets and liabilities, reported in our consolidated financial statements and their accompanying notes (“Financial Statements”). Understanding our accounting policies and the extent to which our management uses judgment, assumptions and estimates in applying these policies is integral to understanding our Financial Statements. We describe our most significant accounting policies in Note 2, “Significant Accounting Policies” in the notes to the Financial Statements beginning on page F-1 found elsewhere herein. We have identified the following accounting policies as those that require significant judgments, assumptions and estimates and that have a significant impact on our financial condition and results of operations. These policies are considered critical because they may result in fluctuations in our reported results from
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period to period due to the significant judgments, estimates and assumptions about highly complex and inherently uncertain matters and because the use of different judgments, assumptions or estimates could have a material impact on our financial condition or results of operations. We evaluate our critical accounting estimates and judgments required by our policies on an ongoing basis and update them as appropriate based on changing conditions .
Revenue Recognition, Discounts, and Allowances Accruals
We recognize revenues when: (i) persuasive evidence of an arrangement exists; (ii) the fees are fixed or determinable; (iii) no significant Company obligations remain; and (iv) collection of the related receivable is reasonably assured. We report revenues for transactions in which we are the primary obligor on a gross basis and revenues in which we act as an agent (earning a fixed percentage of the sale) on a net basis, (net of related costs). We report funds collected from customers as deferred revenues until all revenue recognition criteria have been met.
Our revenues are sales of Orthopedic Implants and Biologics to support orthopedic surgeries and wound care. For customers that purchase products as needed, we invoice the customers on the date that the product is utilized. For customers that have consigned product, we invoice the customers as each unit of the product is utilized. Payment terms are due upon receipt of invoice.
Products that have been sold are not subject to returns unless the product is deemed defective. Credits or refunds are recognized when they are determinable and estimable. Net revenues have been reduced to account for sales returns, discounts and other incentives.
Long-Lived Assets
We assess potential impairments to our long-lived assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The events and circumstances we consider when determining whether the carrying value of identifiable intangible assets and other long-lived assets may not be recoverable include, but are not limited to: (i) significant changes in performance relative to expected operating results; (ii) significant changes in the use of the assets; (iii) significant negative industry or economic trends; (iv) a significant decline in our stock price for a sustained period of time; and (v) changes in our business strategy. We record an impairment loss when the carrying amount of the long-lived asset is not recoverable and exceeds its fair value. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. Any required impairment loss is measured as the amount by which the carrying amount of a long-lived asset exceeds fair value and is recorded as a reduction in the carrying value of the related asset and an expense to operating results. Based on our assessment, there were no indicators of impairment of our long-lived assets at December 31, 2017, and 2016.
Goodwill
Goodwill is the excess of the purchase price over the fair value of net assets of acquired businesses. We test goodwill for impairment annually or whenever an event occurs or circumstances change that would indicate that the carrying amount may be impaired. The test for impairment requires that we make several estimates about fair value, most of which are based on projected future cash flows. Our estimates associated with the goodwill impairment test are considered critical due to the amount of goodwill recorded on our consolidated balance sheets and the judgment required in determining fair value, including projected future cash flows. We did not recognize any goodwill impairment during 2017 or 2016.
Fair Value Measurements
Fair value is the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants. We classify assets and liabilities recorded at fair value under the fair value hierarchy based on the observability of inputs used in valuation techniques. Observable inputs (highest level) reflect market data obtained from independent sources, while unobservable inputs (lowest level) reflect internally developed market assumptions. The fair value measurements are classified under the following hierarchy:
Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets and liabilities in active markets;
Level 2—Observable inputs, other than quoted market prices, that are either directly or indirectly observable in the marketplace for identical or similar assets and liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities; and
Level 3—Unobservable inputs that are supported by little or no market activity that are significant to the fair value of assets or liabilities.
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In connection with the CPM Acquisition, we recorded a $19,244,543 liability related to the earn-out portion of the purchase consideration. See Note 3, “Acquisition” in the notes to the Consolidated Financial Statements beginning on page F-1 for further discussion of the Earn-Out Liability and our classification the Earn-Out Liability as a Level 3 liability.
The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The recorded value of notes payable approximates their fair value based upon their effective interest rates.
Accounts Receivable and Allowances
Accounts receivables are non-interest bearing and are stated at gross invoice amounts less an allowance for doubtful accounts receivable and an allowance for contractual pricing. Credit is extended to customers based on an evaluation of their financial condition and other factors. We generally do not require collateral or other security to support accounts receivable. We perform ongoing credit evaluations of our customers and maintain an allowance for potential bad debts.
We estimate our allowance for doubtful accounts by evaluating specific accounts where information indicates the customers may have an inability to meet financial obligations, such as bankruptcy proceedings and receivable amounts outstanding for an extended period beyond contractual terms. In these cases, we use assumptions and judgment, based on the best available facts and circumstances, to record a specific allowance for those customers against amounts due to reduce the receivable to the amount expected to be collected. These specific allowances are reevaluated and adjusted as additional information is received. The amounts calculated are analyzed to determine the total amount of the allowance. We may also record a general allowance as necessary.
Our management estimates an allowance for contractual pricing, by evaluating specific accounts where information indicates the customer is offered contractual pricing and discount allowances. In these arrangements, our management uses assumptions and judgement, based on the best available facts and circumstances, to record a specific allowance for the amounts due from those customers. The allowance is offset by a corresponding reduction to revenue. These specific allowances are reevaluated and adjusted as additional information is received. The amounts calculated are analyzed to determine the total amount of the allowance. We may also record a general allowance as necessary.
Accounts deemed uncollectible are written-off in the period when we have exhausted efforts to collect overdue and unpaid receivables or we have evaluated other circumstances that indicate that our Company should abandon such efforts. Previously written-off accounts receivable subsequently collected are recognized as a reduction of bad debt expense when funds are received.
Inventories
Inventories are stated at lower of cost or the net realizable value (first-in, first-out). Our inventories consist entirely of finished goods and include Orthopedic Implants and Biologics. We review the market value of inventories whenever events and circumstances indicate that the carrying value of inventories may not be recoverable from the estimated future sales price less cost of disposal and normal gross profit. In cases where the market values are less than the carrying value, we recognize a write-down equal to an amount by which the carrying value exceeds the market value of inventories.
Stock-Based Compensation
Stock-based compensation expense is measured at the grant date fair value of the award and is expensed over the requisite service period. For employee stock-based awards, we calculate the fair value of the award on the date of grant using the Black-Scholes option pricing model. Determining the fair value of stock-based awards at the grant date under this model requires judgment, including estimating volatility, employee stock option exercise behaviors and forfeiture rates. The assumptions used in calculating the fair value of stock-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. For non-employee stock-based awards, we calculate the fair value of the award on the date of grant in the same manner as employee awards, however, the awards are revalued at the end of each reporting period and the pro-rata compensation expense is adjusted accordingly, until such time that the non-employee award is fully vested, at which time the total compensation recognized to date shall equal the fair value of the stock-based award as calculated on the measurement date, which is the date at which the award recipient’s performance is complete. The estimation of stock-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised.
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Because of the CPM Acquisition, Fuse became the sole managing member of CPM and as a result, began consolidating the financial results of CPM. CPM is treated as a partnership for U.S. federal and most applicable state and local income tax purposes. As a partnership, CPM is not subject to either U.S. federal or most applicable state and local income taxes. Any taxable income or loss generated by CPM is passed through to, and included in, the taxable income or loss of its members.
We use the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount that more likely than not will be realized. We have deferred tax assets and liabilities that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Deferred tax assets are subject to periodic recoverability assessments. Realization of the deferred tax assets, net of deferred tax liabilities, is principally dependent upon achievement of projected future taxable income.
We record a liability for uncertain tax positions when it is probable that we have incurred a loss and we can reasonably estimate its amount. As of December 31, 2017, we had no liabilities for uncertain tax positions. Our policy is to recognize interest and penalties related to income tax matters as a component of income tax expense. We continually evaluate expiring statutes of limitations, audits, proposed settlements, changes in tax law, and new authoritative rulings.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers.” ASU 2014-09 is a comprehensive revenue recognition standard that will supersede nearly all existing revenue recognition guidance under current GAAP and replace it with a principle-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing, and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. Early adoption is permitted only in annual reporting periods beginning after December 15, 2016, including interim periods therein. Entities will be able to transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. We are in the process of evaluating the impact of ASU 2014-09 on our financial statements and disclosures.
In July 2015, the FASB issued ASU No. 2015-11 — “Inventory (Topic 330)”, which requires an entity to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. We adopted ASU 2015-11 as of January 1, 2017, and did not have a material impact on our financial statements.
In February 2016, the FASB issued Accounting Standards Update No. 2016-02, “Leases”, which requires a lessee to record a right of use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018. Early adoption is permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. We are in the process of evaluating the impact of the adoption of ASU 2016-02 on our financial statements and disclosures.
In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash payments.” The update addresses eight (8) specific cash flow issues with the objective of reducing the existing diversity in practice. This ASU is effective for the public business entities for fiscal years beginning after December 15, 2017, and for interim periods within those fiscal years. The amendments in this update may be applied retrospectively or prospectively and early adoption is permitted. We are in the process of evaluating the impact of ASU 2016-15 on our financial statements and disclosures.
In November 2016, the FASB issued ASU Update No. 2016-18 — “Statement of Cash Flows (Topic 230): Restricted Cash (A Consensus of the FASB EITF).” ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. These amounts should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. This amendment does not provide a definition of restricted cash or restricted cash equivalents. The update will be effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. We are in the process of evaluating the impact of ASU 2016-18 on our financial statements and disclosures.
Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC did not or are not believed by management to have a material impact on our present or future consolidated financial statements.
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Cautionary Note Regarding Forward Looking Statements
This report contains forward-looking statements, including the statements regarding capital expenditures and liquidity.
The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategies, and financial needs.
The results anticipated by any or all of these forward-looking statements might not occur. Important factors, uncertainties, and risks that may cause actual results to differ materially from these forward-looking statements are contained in “Item 1A. Risk Factors” above. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise. For more information regarding some of the ongoing risks and uncertainties of our business, see “Item 1A. Risk Factors” and our other filings with the SEC.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not required for smaller reporting companies.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
The requirements of this Item can be found in our Financial Statements beginning on page F-1 herein.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Based upon the evaluation required by Section 13a-15(b) of the Exchange Act, our Chief Executive Officer and our Chief Financial Officer, with the participation of our Board, believe that our disclosure controls and procedures, as of December 31, 2017, are significantly improved since December 31, 2016. We believe that our improvements in disclosure controls and procedures resulted primarily from our integration of Fuse operations with CPM’s operations. We deemed CPM’s internal controls over financial reporting to be more established and stable than Fuse’s because CPM was previously subject to five external audits and CPM’s internal controls had more significant volume, scope, and complexity than Fuse’s internal controls.
Our management is responsible for establishing and maintaining adequate internal controls over our financial reporting. As a result of the change in leadership and the significant restructuring and rebranding efforts deemed by our Board as strategically necessary, our management was unable to complete its full and complete assessment regarding the establishment and maintenance of adequate internal controls over our financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control — Integrated Framework . Due to the delay in fulling completing this process, we are unable to conclude that internal controls over financial reporting were effective as of December 31, 2017. However, our Board, Chief Executive Officer, and Chief Financial Officer continue to work with our independent third-party Sarbanes-Oxley Consultant to assist in establishing a sustainable framework and processes to ensure adequate internal controls over financial reporting. We are currently in the process of testing the operating effectiveness of the internal controls over financial reporting. We expect to complete our assessment and develop conclusions on the operating effectiveness of the controls over financial reporting by June 30, 2018.
Changes in Internal Control over Financial Reporting
During 2017, we integrated the Fuse supply chain management, finance, sales support, and other related functions with the operations of CPM. We outsource our payroll processing, employee benefit administration, and related human capital services to AmBio. We believe these arrangements have significantly improved internal controls over financial reporting and have provided us scalability for anticipated growth and expansion, while driving down fixed costs per transaction. We now incorporate strict access controls for our inventory management system and general ledger system, which allows us to better control our financial results and to implement monthly closes, instead of quarterly closes with strict access to closed periods. Having monthly closes provides increased accuracy on
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our financial results and allows executives to evaluate our business more strategically because they can view the financials each month rather than each quarter.
On January 30, 2018, we received notice from UOC USA, Inc. (“UOC”) that UOC has elected to terminate the distribution agreement dated January 1, 2011, as amended (the “UOC Agreement”) between our wholly-owned subsidiary, CPM, and UOC. While the UOC Agreement terminated on February 28, 2018, in accordance with its terms and conditions, the UOC Agreement also authorized the continued provision of UOC products at UOC-contracted facilities until March 15, 2018. Because we hold title to our UOC inventory, we may continue selling UOC products until we deplete our UOC inventory.
Pursuant to the UOC Agreement, in consideration for mutual promises and covenants, we were appointed as a non-exclusive authorized distributor of UOC orthopedic implants and instruments for an initial fixed term of two (2) years with auto-renewals thereafter. We or UOC could terminate the UOC Agreement at any time and for any reason upon ninety (90) days prior written notice to the other party.
At UOC’s sole discretion, the termination notice provides for the repurchase of our unsold UOC orthopedic implants by UOC on or before April 30, 2018. Our revenue derived from the sale and distribution of UOC products was approximately $4.3 million or 16% of total revenue and $4.9 million or 19% of total revenue, for the year-ended December 31, 2017, and December 31, 2016, respectively.
We offer our customers a broad portfolio of orthopedic implant alternative products and believe we have adequate Orthopedic Implant and instrument stock levels to support our business and operations through the end of the second quarter ended June 30, 2018. We are currently negotiating new stocking distribution agreements with two manufacturing companies for non-exclusive distribution rights in the United States for their total knee and total hip replacement systems. We are also evaluating the opportunity to license those manufacturing companies’ technology for our own branding opportunities.
We believe a replacement supplier is critical to our business. If we experience any delays in contracting for suitable substitutes, we may not be able to fulfill some of our customers’ needs.
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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Executive Officers and Directors
The following table sets forth information regarding our current executive officers and directors. There is no agreement or understanding between us and each director or executive officer pursuant to which they were selected as an officer or director.
Name |
|
Age |
|
Position |
Christopher C. Reeg |
|
54 |
|
Chief Executive Officer, Secretary and Director |
Mark W. Brooks |
|
52 |
|
Chairman of the Board, President and Director |
Renato V. Bosita, Jr. MD |
|
46 |
|
Independent Director |
Ricky Raj S. Kalra MD |
|
36 |
|
Independent Director |
William E. McLaughlin III |
|
54 |
|
Chief Financial Officer, Treasurer and Director |
Christopher C. Reeg has served as our Chief Executive Officer and a member of our Board since December 19, 2016. Effective January 18, 2018, our Board appointed Mr. Reeg to the additional role as Secretary. Mr. Reeg currently serves as the President of Maxim Surgical, a manufacturer and distributor of spinal and orthopedic implants that he founded in 2011. Mr. Reeg led the design, development and successful commercialization of a spinal implant that received FDA approval in 2013 and is currently manufactured and distributed by Maxim Surgical. Prior to forming Maxim Surgical, Mr. Reeg founded LMI Ortho, a distributor of spine and orthopedic implants purchased from domestic and international manufacturers and suppliers. While at LMI Ortho, Mr. Reeg acquired importation rights for a total joint orthopedic portfolio. Working with surgeons in the United States, Mr. Reeg expanded implant product lines and developed effective growth strategies based on design and market intelligence. Before entering the orthopedic industry with LMI Ortho in 1996, Mr. Reeg formed Spectramed, Inc., a multi-state home respiratory company where he served as its President until the sale of Spectramed, Inc., to a national healthcare company in 2001. Having founded two medical implant manufacturing and distributing companies and served as President for one medical implants manufacturing and distribution company, Mr. Reeg brings to our Board significant experience and knowledge regarding how to successfully navigate the medical device industry.
Mark W. Brooks has served as our Director and Chairman of the Board since December 19, 2016. Effective January 18, 2018, our Board appointed Mr. Brooks to the additional role as President. Prior to the CPM Acquisition, Mr. Brooks served as the Chief Executive Officer of CPM, a privately-owned national distributor of medical devices and regenerative tissue. Prior to forming CPM in 2002, Mr. Brooks partnered with Mr. Reeg during the formation and growth of Home Health Equipment, Inc. (“Home Health”), a durable medical equipment provider contracting with acute home health agencies and hospitals in several states. In 1996, Messrs. Brooks and Reeg sold Home Health to predecessor companies of Tenet Healthcare Corporation. Having successfully served as Chief Executive Officer of a national distributor of medical devices, Mr. Brooks brings considerable expertise in the strategic management and growth of medical device distribution to our Board.
Renato V. Bosita Jr. MD has served as an independent member of our Board since his appointment on August 1, 2017. Dr. Bosita is a spine fellowship-trained orthopedic spine surgeon based in Plano, Texas. He attended Stanford University where he received a degree in biological sciences in 1992. He then attended the University of Chicago Pritzker School of Medicine and completed his residency in orthopedic surgery at Loyola University Medical Center. While a resident at Loyola University Medical Center in 2001, Dr. Bosita earned a Masters of Business Administration degree from the University of Northwestern J.L. Kellogg Graduate School of Management. Dr. Bosita completed his spine fellowship at the University Hospitals of Cleveland in 2002. Dr. Bosita currently practices as a spine surgeon at the Texas Back Institute, Plano, Texas. Additionally, Dr. Bosita is the Chairman of the Board of Managers for Presbyterian Hospital of Rockwall and is a member of the finance committee. Dr. Bosita was appointed to the Board for his experience in the healthcare industry and business acumen.
Ricky Raj S. Kalra MD has served as an independent member of our Board since his appointment on July 13, 2017. Dr. Kalra is a spine fellowship-trained neurosurgeon based in Dallas, Texas. He attended Rice University where he received a degree in economics. He also attended London School of Economics as a Hansard Scholar. Dr. Kalra worked at Merrill Lynch in its investment banking group as an Energy and Power analyst after his undergraduate education. He then attended Washington University School of Medicine in Saint Louis finishing in 2009 and completed his neurosurgery residency at the University of Utah in 2016. As part of his spine fellowship in 2015, Dr. Kalra trained in Germany under Dr. Rudolf Beisse. Dr. Kalra has published more than 20 scientific articles and book chapters and has received the Preuss award by the Congress of Neurological Surgeons for his research in brain tumors. Dr. Kalra was appointed to the Board for his financial acumen as well as experience in healthcare.
William E. McLaughlin III has served as a member of our Board since December 19, 2016, and as Interim Chief Financial Officer from March 31, 2017, until January 18, 2018, when our Board appointed Mr. McLaughlin, to the position of Chief Financial Officer
27
and Treasurer. Mr. McLaughlin, 54, was elected as a member of our Board on December 19, 2016. Mr. McLaughlin is a Certified Public Accountant licensed in the State of Texas and has over 25 years of experience in accounting and financial reporting for private and large public companies traded on the New York Stock Exchange and NASDAQ Stock Market (“NASDAQ”) in addition to “Big-Four” public accounting. Mr. M cLaughlin has served as Chief Financial Officer of CPM since 2014. Mr. McLaughlin joined CPM as Vice President Finance, Controller in 2013. From 2006 until he joined CPM, Mr. McLaughlin served as Vice President Finance, Controller for Caris Life Sciences, Inc., a $180 million international, anatomic pathology , and molecular biotechnology laboratories and multi-state physician practices enterprise. Having over 25 years of experience in accounting and financial reporting for private and public companies, Mr. McLaughlin brings considerable financial expertise to our Board.
Family Relationships
There are no family relationships among our existing or incoming directors or officers.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our officers and directors, and persons who own more than ten percent of a registered class of our equity securities, to file with the SEC initial reports of ownership and reports of changes in ownership of Common Stock and other equity securities. Officers, directors, and greater than ten percent stockholders are required by SEC rules to furnish us with copies of all Section 16(a) reports that they file.
We believe that, during 2017, our directors, executive officers, and ten percent stockholders complied with all Section 16(a) filing requirements, except for the following:
|
• |
A late Form 4 report was filed for Mark W. Brooks on October 10, 2017, to report the acquisition of 65,000 shares of Common Stock that occurred on September 21, 2017. |
|
• |
A late Form 4 report was filed for Mark W. Brooks on February 8, 2018, to report the acquisition of 50,000,000 shares of Common Stock that occurred on December 29, 2017. |
|
• |
A late Form 3 report was filed for Renato V. Bosita Jr. on October 10, 2017, to report his appointment to the Board that occurred on August 1, 2017. |
|
• |
A late Form 4 report was filed for Renato V. Bosita Jr. on October 10, 2017, to report the acquisition of 1,065,000 shares of Common Stock that occurred on September 21, 2017. |
|
• |
A late Form 3 report was filed for Ricky Raj S. Kalra on October 10, 2017, to report his appointment to the Board that occurred on July 13, 2017. |
|
• |
A late Form 4 report was filed for Ricky Raj S. Kalra on October 10, 2017, to report the acquisition of 1,065,000 shares of Common Stock that occurred on September 21, 2017. |
|
• |
A late Form 4 report was filed for William E. McLaughlin III on October 10, 2017, to report the acquisition of 65,000 shares of Common Stock that occurred on September 21, 2017. |
|
• |
A late Form 4 report was filed for Christopher C. Reeg on October 10, 2017, to report the acquisition of 65,000 shares of Common Stock that occurred on September 21, 2017. |
In making these statements, we have relied upon examination of the copies of Forms 3, 4, and 5, and amendments to these forms provided to us, and the written representations of our directors, executive officers, and ten percent stockholders.
Code of Ethics
Our Board has adopted a code of ethics (the “Code of Ethics”) that applies to all our employees, including our Chief Executive Officer and Chief Financial Officer. The Code of Ethics provides written standards that we believe are reasonably designed to deter: i) wrongdoing; ii) promote honest and ethical conduct, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships; (iii) encourage full, fair, accurate, timely, and understandable disclosure and compliance with laws, rules, and regulations, including insider trading, corporate opportunities, and whistle-blowing; and (iv) encourage the prompt reporting of illegal or unethical behavior. We will provide a copy of the Code of Ethics to any person without charge, upon request. The request for a copy can be made in writing to Fuse Medical, Inc., 1565 North Central Expressway, Suite 220, Richardson TX, 75080, Attention: Corporate Secretary.
Corporate Governance
We do not believe that with the current size of our Company, it is necessary for us to have a separately-designated audit committee, therefore our entire Board serves as the audit committee. William E. McLaughlin III serves as our “audit committee financial expert,” as such term is defined under the rules promulgated under the Exchange Act. Mr. McLaughlin meets the requirements of serving as
28
out “audit committee financial expert” from his extensive background in accounting and financial reporting for both privat e and large public companies (s ee “ Item 10, Executive Officers and Directors ” ) .
We are not required to have and currently do not have a compensation committee. We do not believe it is necessary for our Board to appoint a compensation committee because the volume of compensation matters that will come before our Board for consideration is minimal and permits our entire Board to give sufficient time and attention to such matters to be involved in all decision making.
Our entire Board participates in matters related to executive officer and director compensation. Our Board will consider the recommendations of our Chief Executive Officer when determining compensation for our other executive officers. Our Chief Executive Officer has no role in determining his own compensation. We have not paid fees to or engaged any compensation consultants.
We are also not required to have and do not have a nominating committee. Given the limited scope of our operations, our Board believes appointing a nominating committee would be premature and of little assistance until our business operations are at a more advanced level.
We have not made any material changes to the procedures to which the security holders may recommend nominees to the Board.
Stockholder Communications
Although we do not have a formal policy regarding communications with our Board, our stockholders may communicate with our Board by writing to us at Fuse Medical, Inc., 1565 North Central Expressway, Suite 220, Richardson, TX 75080, Attention: Investor Relations, or by facsimile (469) 862-3035. Stockholders who would like their submission directed to a specific member of our Board may so specify, and the communication will be forwarded, as appropriate.
Board Leadership Structure Oversight
Our Board does not have a policy as to whether the roles of Chairman of the Board and Chief Executive Officer should be separate or combined. Currently, our Chairman of the Board is Mark W. Brooks and our Chief Executive Officer is Christopher C. Reeg. Our Board has determined that this current structure, with separate roles for our Chairman of the Board and our Chief Executive Officer is in our best interests and our stockholders’ best interests at this time. Several factors support the leadership structure chosen by our Board, including, among others:
|
• |
Our Board believes this governance structure promotes balance between our Board’s independent authority to oversee our business and our Chief Executive Officer and his management team, who manage the business on a day-to-day basis. |
|
• |
The current separation of our Chairman of the Board and our Chief Executive Officer roles allows our Chief Executive Officer to focus his time and energy on operating and managing our Company and leverage the experience and perspectives of our Chairman of the Board. |
Board Assessment of Risk
Our Board’s primary function is one of oversight. Our Board has responsibility for risk oversight and reviews management’s risk assessment and risk management policies and procedures. Our Board considers and reviews, with our independent registered public accounting firm and our executive management team, the adequacy of our internal controls, including the processes for identifying significant risks and exposures, and our Board elicits recommendations for the improvements of such procedures where desirable. Members of our executive management team have day-to-day responsibility for risk management and establishing risk management practices, and are expected to report matters directly to our entire Board. Members of our executive management team have an open line of communication to our Board and have the discretion to raise issues from time-to-time in any manner they deem appropriate, and our executive management’s reporting on issues relating to risk management typically occurs through direct communication with our Board as matters requiring attention arise. Members of our executive management team regularly attend portions of our Board meetings, and often discuss the risks related to our business.
ITEM 11. EXECUTIVE COMPENSATION.
Compensation Discussion and Analysis
The following discussion and analysis of our compensation arrangements with our named executive officers should be read together with the compensation tables and related disclosures set forth elsewhere in this Annual Report. Our named executive officers for the year ended December 31, 2017 were:
29
|
• |
William E. McLaughlin, III, Chief Financial Officer |
|
• |
Mark W. Brooks, President |
This discussion contains forward-looking statements that are based on our current plans and expectations regarding future compensation programs.
In place of having a separate Compensation Committee, which is not required based on the size of our Company, our Board is charged with the responsibility for establishing, implementing, and monitoring adherence to our compensation philosophy and ensuring that our executives and key management personnel are effectively compensated in a manner which is internally equitable. Our Board is also responsible for reviewing the compensation of directors.
Compensation Philosophy and Objectives.
Our Board’s overall philosophy in terms of executive compensation is to attract, retain, and motivate highly qualified individuals to achieve our business goals and link their interests with shareholder interests. Our compensation plans are designed to motivate and reward employees for achievement of positive business results and to promote and enforce accountability. Our objective is that our executive compensation will reflect the long-term performance of our Common Stock through our equity incentive programs.
Elements of Compensation.
The total compensation program for our executive officers consists of the following:
|
• |
Base Salary; |
|
• |
Cash incentive and bonus awards tied to the executive’s and our annual and/or quarterly performance; |
|
• |
Long-term incentive compensation, in the form equity awards; and |
|
• |
Health benefits |
Our Board seeks to structure each element of compensation to attract and retain the necessary executive talent, reward annual performance, and provide incentives for both long-term strategic goals and short-term performance. Our Board’s strategy for allocating between currently paid and long-term compensation is to ensure adequate base compensation to attract and retain personnel, while providing incentives to maximize long-term value for our shareholders.
Our Company has no formal policy for allocating compensation among the compensation elements described above.
Setting Executive Compensation.
Our Board is responsible for establishing and periodically reviewing the compensation of our executive officers and approving all equity awards. Our Board periodically reviews the performance of our executive officers and determines whether salary adjustments are necessary or recommended.
Base Salary.
We pay each of our executives a base salary in cash on a bi-weekly basis. This base salary is designed to compensate our executives for the performance of their normal responsibilities, and it is the only component of their compensation that is considered to be fixed rather than variable in nature.
The base-salary for our executives for the year ending December 31, 2017 is as follows:
|
• |
Christopher C. Reeg: $240,000 |
|
• |
William E. McLaughlin: $161,604 |
|
• |
Mark W. Brooks: $0.00 |
Christopher C. Reeg has served as our Chief Executive Officer and a member of our Board since December 19, 2016. Mr. Reeg has the highest base salary of our Named Executive Officers, this is due mostly in part for the amount of responsibility and oversight this position requires. Mr. Reeg has an extensive experience and knowledge of the medical device industry and continually proves to be a successful leader.
30
William E. McLaughlin, III has the second highest base salary of our Named Executive Officers. As Chief Financial Officer, Mr. McLaughlin holds the majority responsibility for the financial well -being of our Company. The responsibility of the position along with Mr. McLaughlin’s extensive financial and accounting background gives reason for his salary.
Mark W. Brooks was appointed to the executive position of President by our Board on January 18, 2018. For the years 2017 and prior, we did not pay Mr. Brooks a base salary, however we did compensate Mr. Brooks through distributions and commissions, which were based on our performance.
Cash Incentive and Bonus Awards.
Cash incentive awards may be paid if we meet or exceed performance goals as determined by our Board for that year. Cash Incentive or Bonus Awards are not required to be given to the executives and are recommended and approved solely at the discretion of our Board.
Long- Term Incentive Compensation.
We have the power to provide compensation to our executives based on the value of and changes in the value of our Common Stock. Our 2017 Equity Incentive Plan (“2017 Equity Plan”), which we filed with the SEC as Exhibit 99.2 to our Current Report on Form 8-K on April 6, 2017, which is hereinafter incorporated by reference (“April 2017 Form 8-K”), authorizes the Board to grant stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock awards to our management employees. In 2017, we granted all three of our Named Executive Officers two separate restricted stock awards (“RSAs”) the material terms of which are governed by the 2017 Equity Plan, filed in our April 2017 Form 8-K. However, the equity compensation was granted to our executives as compensation for their services as members of our Board. The RSAs for these executives are as follows:
|
• |
Christopher C. Reeg; Chief Executive Officer |
|
o |
65,000 shares of restricted Common Stock granted on September 21, 2017 |
|
o |
188,500 shared of restricted Common Stock granted on December 14, 2017 |
|
• |
William E. McLaughlin; Chief Financial Officer |
|
o |
65,000 shares of restricted Common Stock granted on September 21, 2017 |
|
o |
188,500 shared of restricted Common Stock granted on December 14, 2017 |
|
• |
Mark W. Brooks; President |
|
o |
65,000 shares of restricted Common Stock granted on September 21, 2017 |
|
o |
188,500 shared of restricted Common Stock granted on December 14, 2017 |
The following information is related to the compensation paid, distributed, or accrued by our Company for 2017 and 2016, to our Chief Executive Officer (“Principal Executive Officer”) and the other most highly compensated executive officers serving at the end of the last fiscal year whose compensation exceeded $100,000, who we refer to as “Named Executive Officers.”
2017 Summary Compensation Table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity |
|
|
Non- Qualified |
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incentive Plan |
|
|
Deferred Compen- |
|
|
All Other |
|
|
|
|
|
|||
Name and |
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
Option |
|
|
Compen- |
|
|
sation |
|
|
Compen- |
|
|
|
|
|
|||||
Principal Position |
|
Year |
|
Salary |
|
|
Bonus |
|
|
Awards |
|
|
Awards |
|
|
sation |
|
|
Earnings |
|
|
sation |
|
|
Total |
|
||||||||
(a) |
|
(b) |
|
($)(c) |
|
|
($)(d) |
|
|
($)(e) (1)(7) |
|
|
($)(f) (1) |
|
|
($)(g) |
|
|
($)(h) |
|
|
($)(i) (5) |
|
|
($)(j) |
|
||||||||
Christopher C. Reeg (2) |
|
2017 |
|
$ |
240,000 |
|
|
|
- |
|
|
$ |
50,700 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
32,164 |
|
|
$ |
322,864 |
|
Chief Executive Officer |
|
2016 |
|
$ |
240,000 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
27,739 |
|
|
$ |
267,739 |
|
William E. McLaughlin III (3) |
|
2017 |
|
$ |
161,604 |
|
|
|
- |
|
|
$ |
50,700 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
212,304 |
|
Chief Financial Officer |
|
2016 |
|
$ |
155,086 |
|
|
$ |
20,000 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
175,086 |
|
Mark W. Brooks (4)(6) |
|
2017 |
|
|
- |
|
|
|
- |
|
|
$ |
50,700 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
100,833 |
|
|
$ |
151,533 |
|
President |
|
2016 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
(1) |
Amounts reflect the aggregate grant date fair value, without regard to forfeitures, computed in accordance with ASC 718. (See Note 1 in our accompanying consolidated financial statements) |
(2) |
Appointed December 19, 2016, as our Chief Executive Officer. On January 18, 2018, we appointed Mr. Reeg as our Corporate Secretary. |
31
(3) |
Appointed April 6, 2017, as our Interim Chief Financial Officer. On January 18, 2018, we appointed Mr. McLaughlin as our Chief Financial Officer and Treasurer. |
(4) |
On January 18, 2018, we appointed Mr. Brooks as our President. Mr. Brooks has served as the Chairman of our Board since December 19, 2016. |
(5) |
All other compensation consists of commissions we paid to the Named Executive Officer or entity owned and controlled by the Named Executive Officer. |
(6) |
Our Chairman of our Board and President, Mr. Brooks historically was not paid a salary by our Company. Mr. Brooks did receive compensation through various distributions. |
(7) |
Stock Awards consists of Restricted Stock Awards that were granted to the Named Executive Officers for the services as Directors of the Board. |
Provisions of Termination or Change-In-Control
In the event of a change-in-control, NC 143 would receive earn-out payments pursuant to the CPM Acquisition Agreement.
Other Executive Compensation Arrangements
None.
Outstanding Awards at Fiscal Year End
The following information is descriptive of options of shares of Common Stock which have not vested which have been granted to our Named Executive Officers as of December 31, 2017.
|
Option Awards |
|
|
Stock Awards |
|
||||||||||||||||||||||||||||||
Name and Principal Position (a) |
Number of securities underlying unexercised options (#) exercisable (b) |
|
|
Number of securities underlying unexercised options (#) unexercisable (b) |
|
|
Equity incentive plan awards: number of securities underlying unexercised unearned options (#) (d) |
|
|
Option exercise price ($) (e) |
|
|
Option expiration date (f) |
|
|
Number of shares or units of stock that have not vested (#) (g) (1) |
|
|
Market value of shares or units of stock that have not vested (#) (h) |
|
|
Equity incentive plan awards: number of unearned shares, units or other rights that have not vested (#) (i) |
|
|
Equity incentive plan awards: market or payout value of unearned shares, units or other rights that have not vested ($) (j) |
|
|||||||||
Christopher C. Reeg Chief Executive Officer |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
253,500 |
|
|
$ |
50,700 |
|
|
|
- |
|
|
|
- |
|
William E. McLaughlin, III Chief Financial Officer |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
253,500 |
|
|
|
50,700 |
|
|
|
- |
|
|
|
- |
|
Mark W. Brooks President |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
253,500 |
|
|
$ |
50,700 |
|
|
|
- |
|
|
|
- |
|
32
Director Compensation
The following discussion and analysis of our compensation arrangements with our directors should be read together with the compensation tables and related disclosures set forth elsewhere in this 2017 Annual Report. Please note that this disclosure excludes our other three (3) directors who also serve as Named Executive Officers to our Company. Please refer to the above 2017 Summary Compensation table and narrative for information about the compensation those executive officers received in their capacities as directors.
Our independent directors (“Independent Directors”) for the year ended December 31, 2017 were:
|
• |
Ricky Raj S. Kalra, MD |
|
• |
Renato V. Bosita Jr., MD |
Philosophy
Our Board receives comparative market data and recommendations regarding the structure of our non-management director compensation and the amounts paid through either cash-incentives or equity awards to our non-management directors. As of the year ending December 31, 2017 our Board does not pay independent directors a retainer in the form of cash compensation.
Equity Incentive Compensation
We have the power to provide compensation to both our management and non-management based directors on the value of and changes in the value of our Common Stock. Our 2017 Equity Incentive Plan (“2017 Equity Plan”), which we filed with the SEC as Exhibit 99.2 to our Current Report on Form 8-K on April 6, 2017, which is hereinafter incorporated by reference (“April 2017 Form 8-K”), authorizes the Board to grant stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock awards to the members of our Board. In 2017, we granted both the Independent Directors three separate restricted stock awards (“RSAs”) the material terms of which are governed by the 2017 Equity Plan, filed in our April 2017 Form 8-K. Two of those RSAs, which we granted to all members of our Board, were for general compensation. One of those RSAs, which we granted to both the Independent Directors, was for special services to the Board. The RSAs for the Independent Directors are as follows:
|
• |
Ricky Raj S. Kalra, MD |
|
o |
65,000 shares of restricted Common Stock granted on September 21, 2017; |
|
o |
188,500 shares of restricted Common Stock granted on December 14, 2017; and |
|
o |
1,000,000 shares of restricted Common Stock granted on September 21, 2017, this award is subject to our Company achieving certain milestones and will only vest upon the earlier of a change-in-control of our Company, or our Company being listed on a national securities exchange |
|
• |
Renato V. Bosita, Jr., MD |
|
o |
65,000 shares of restricted Common Stock granted on September 21, 2017; |
|
o |
188,500 shares of restricted Common Stock granted on December 14, 2017; and |
|
o |
1,000,000 shares of restricted Common Stock granted on September 21, 2017, this award is subject to our Company achieving certain milestones and will only vest upon the earlier of a change-in-control of our Company, or our Company being listed on a national securities exchange. |
Special Committee Compensation
Upon the formation of a special committee to address a specific issue, our Board determines the amount of an annual retainer that should be paid to the special committee members based upon the amount of time and effort we expect those individuals will spend as a member of that special committee. In 2017, we compensated director Ricky Raj S. Kalra, MD, $10,000, for the extra time and services that he gave while serving as the leader director of a special committee specifically for the independent input on the CPM Acquisition.
2017 Director Compensation
33
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in Pension |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value and Nonqualified |
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned or |
|
|
|
|
|
|
|
|
|
|
Non-Equity Incentive |
|
|
Deferred Compen- |
|
|
All Other |
|
|
|
|
|
||||
|
|
Paid in |
|
|
Stock |
|
|
Option |
|
|
Plan |
|
|
sation |
|
|
Compen- |
|
|
|
|
|
||||||
Name |
|
Cash |
|
|
Awards |
|
|
Awards |
|
|
Compensation |
|
|
Earnings |
|
|
sation |
|
|
Total |
|
|||||||
(a) |
|
($)(b) |
|
|
($)(c) (1) |
|
|
($)(d) |
|
|
($)(e) |
|
|
($)(f) |
|
|
($)(g) (4) |
|
|
($)(j) |
|
|||||||
Ricky Raj S. Kalra MD (2) |
|
|
- |
|
|
$ |
830,700 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
10,000 |
|
|
$ |
840,700 |
|
Renato V. Bosita Jr. MD (3 ) |
|
|
- |
|
|
$ |
830,700 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
$ |
830,700 |
|
|
(1) |
Amounts reflect the aggregate grant date fair value, without regard to forfeitures, computed in accordance with ASC 718. (See Note 1 in our accompanying consolidated financial statements) |
|
(2) |
Director has three (3) Restricted Stock Awards; (i) 65,000 shares granted on September 21, 2017 with a 12-month vest from the date of grant; (ii) 188,500 shares granted on December 14, 2017 with a 9-month vest from the date of grant; (iii) 1,000,000 shares granted on December 14, 2017 will vest on the earlier of a change-in-control or our Company’s listing on a national exchange. |
|
(3) |
Director has three (3) Restricted Stock Awards; (i) 65,000 shares granted on September 21, 2017 with a 12-month vest from the date of grant; (ii) 188,500 shares granted on December 14, 2017 with a 9-month vest from the date of grant; (iii) 1,000,000 shares granted on December 14, 2017 will vest on the earlier of a change-in-control or our Company’s listing on a national exchange |
|
(4) |
All other compensation consists of services provided to the Board in connection with the independent special committee. |
Standard compensation arrangements consist of stock awards issued to all five (5) directors of the Board. The two (2) independent directors listed in the table above received an additional stock award for our Company achieving milestone targets. Independent directors who participated on the special committee received a one-time cash payment.
Risk Assessment Regarding Compensation Policies and Practices
Our compensation program for employees does not create incentives for excessive risk taking by our employees or involve risks that are reasonably likely to have a material adverse effect on our Company. Our compensation has the following risk-limiting objectives:
|
• |
To decrease the incentive to take unnecessary or imprudent risks, our base pay programs consist of competitive salary rates that represent a reasonable portion of total compensation and provide a reliable level of income on a regular basis, to decrease the incentive to take unnecessary or imprudent risks; |
|
• |
To reduce the risk that executives will focus on specific short-term outcomes, we do not tie incentive compensation to formulas; |
|
• |
To discourage employees from taking risks to meet certain performance goals, we may recover our equity awards should a restatement of earnings occur upon which incentive compensation awards were based or in the event of other wrongdoing by the recipient; and |
|
To discourage the taking of a short-term risk at the e xpense of long-term performance , our equity awards generally have multi-year vesting, which aligns the long-term interests of our executives with those of our stockholders. |
|
Our Chief Financial Officer and Chief Executive Officer review our Company’s compensation policies on a quarterly basis to see if our Company is meeting the above risk management objectives. Our Board also annually reviews our compensation policies to make sure a similar outcome of checking out risk management objectives are being met.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Equity Compensation Plan Information
The following chart reflects the number of awards granted under equity compensation plans approved and not approved by stockholders and the weighted average exercise price for such plans as of December 31, 2017.
34
Name of Plan |
|
Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) |
|
|
Weighted average exercise price of outstanding options, warrants and rights (b) |
|
|
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) |
|
|||
Equity compensation plans approved by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
None |
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
Equity compensation plans not approved by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
2017 Equity Incentive Plan |
|
|
4,500,000 |
|
|
|
(1 |
) |
|
|
1,232,500 |
|
Total |
|
|
4,500,000 |
|
|
$ |
- |
|
|
|
1,232,500 |
|
|
(1) |
There were no outstanding options, warrants, and rights issued under the 2017 Equity Incentive Plan. |
As of December 31, 2017, there were stock options to purchase 1,302,052 shares of our Common Stock at a weighted average exercise price of $0.20 per share outstanding that were not subject to any equity compensation plan.
Our Company has a stock-based compensation plan, the 2017 Equity Incentive Plan (the “2017 Plan”) which provides for the granting of equity awards, including qualified incentive and non-qualified stock options, stock appreciation awards and restricted stock awards to employees, directors, consultants, and advisors. Our Company’s Board adopted the 2017 Plan on April 5, 2017 and disclosed it as Exhibit 99.2 in our Current Report on Form 8-K, filed with the SEC on April 8, 2017, which is herein incorporated by reference. The awards are subject to a vesting schedule as set forth in individual agreements.
On September 21, 2017, our Board approved an amendment to the 2017 Plan to increase the number of shares of Common Stock authorized for issuance under the 2017 Plan from 1,500,000 shares of Common Stock to 2,500,000 shares of Common Stock, as reported in our Current Report on Form 8-K/A filed with the SEC on November 6, 2017 (“November 2017 Form 8-K/A”).
On October 4, 2017, the Board approved an amendment to the 2017 Plan to increase the number of shares of Common Stock authorized for issuance under the 2017 Plan from 2,500,000 shares of Common Stock to 4,500,000 shares of Common Stock as reported in our November 2017 Form 8-K/A.
In the event of certain milestones, such as a change-in-control, any equity award granted under our 2017 Plan will vest immediately.
35
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth the number of shares of our Common Stock beneficially owned as of March 26, 2018 by: (i) those persons known by us to be owners of more than 5% of our Common Stock; (ii) each director; (iii) our Named Executive Officers for 2017; and (iv) all of our executive officers and directors as a group. Unless otherwise specified in the notes to this table, the address for each person is: c/o Fuse Medical, Inc., 1565 North Central Expressway, Suite 220, Richardson, Texas 75080.
|
|
|
|
Amount and |
|
|||||
|
|
Name and Address of |
|
Nature of Beneficial Percent of |
|
|||||
Title of Class |
|
Beneficial Owner |
|
Ownership (1) |
|
|
Class (1) |
|
||
5% Stockholders: |
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Mark W. Brooks (2) |
|
|
56,769,938 |
|
|
|
83.9 |
% |
Common Stock |
|
Christopher C. Reeg (3) |
|
|
5,013,260 |
|
|
|
7.5 |
% |
Directors and Named Executive Officers: |
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Mark W. Brooks (2) |
|
|
56,769,938 |
|
|
|
83.9 |
% |
Common Stock |
|
Christopher C. Reeg (3) |
|
|
5,013,260 |
|
|
|
7.5 |
% |
Common Stock |
|
William E. McLaughlin III (4) |
|
|
253,500 |
|
|
|
0.4 |
% |
Common Stock |
|
Ricky Raj S. Kalra (5) |
|
|
1,253,500 |
|
|
|
1.9 |
% |
Common Stock |
|
Renato V. Bosita Jr. (6) |
|
|
1,253,500 |
|
|
|
1.9 |
% |
Common Stock |
|
All directors and executive officers as a group (5 persons) (7) |
|
|
64,543,698 |
|
|
|
90.4 |
% |
(1) |
Applicable percentages are based on 65,890,808 shares of Common Stock outstanding as of March 26, 2018. Beneficial ownership is determined by SEC rules and generally includes voting or investment power with respect to securities. Shares of Common Stock underlying options and warrants and convertible notes currently exercisable or convertible, or exercisable or convertible within 60 days (of the filing date) are deemed outstanding for computing the percentage of the person holding such securities, but are not deemed outstanding for computing the percentage of any other person. Unless otherwise indicated in the footnotes to this table, we believe that each of the stockholders named in the table has sole voting and investment power with respect to the shares of Common Stock indicated as beneficially owned by them. The table includes shares of Common Stock, options and warrants and convertible notes exercisable or convertible into Common Stock and vested or vesting within 60 days (of the filing date). |
(2) |
Mark W. Brooks. Mr. Brooks is a director. Includes 55,000,000 shares of Common Stock owned by NC 143, 1,516,438 shares issuable upon the conversion of convertible promissory notes held by NC 143, and 253,500 shares issued to Mr. Brooks for his services to the Board. Mr. Brooks has no dispositive investment power over the 253,500 shares awarded pursuant to the restricted stock awards because it is prohibited until the shares have vested. |
(3) |
Christopher C. Reeg. Mr. Reeg is an executive officer and a director. Includes 4,000,000 shares of Common Stock owned by RMI, 759,760 shares issuable upon the conversion of convertible promissory notes held by RMI, and 253,500 shares issued to Mr. Reeg for his services to the Board. Mr. Reeg has no dispositive investment power over the 253,500 shares awarded pursuant to the restricted stock awards because it is prohibited until the shares have vested. |
(4) |
William E. McLaughlin, III. Mr. McLaughlin is an executive officer and a director. Includes 253,500 shares of Common Stock issued to Mr. McLaughlin for his services to the Board. Mr. McLaughlin has no dispositive investment power over the 253,500 shares awarded pursuant to the restricted stock awards because it is prohibited until the shares have vested. |
(5) |
Ricky Raj S. Kalra. Dr. Kalra is a director. Includes 253,500 shares of Common Stock issued to Dr. Kalra for his services to the Board and 1,000,000 shares of Common Stock for providing special services. Dr. Kalra has no dispositive investment power over the 1,253,500 shares awarded pursuant to the restricted stock awards because it is prohibited until the shares have vested. |
(6) |
Renato V. Bosita, Jr. Dr. Bosita is a director. Includes 253,500 shares of Common Stock issued to Dr. Bosita for his services to the Board and 1,000,000 shares of Common Stock for providing special services. Dr. Bosita has no dispositive investment power over the 1,253,500 shares awarded pursuant to the restricted stock awards because it is prohibited until the shares have vested. |
(7) |
All directors and officers as a group. This ownership disclosure includes only the ownership of current executive officers and directors. |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
Change in Control
Between the period July 2016 through October 2016, we obtained three loans in the aggregate amount of $150,000 in exchange for convertible promissory notes (the “Notes”) bearing 10% interest per annum, with principal due and payable, upon demand of the
36
pay ee. The Notes were issued as follows: $100,000 to NC 143 and $50,000 to RMI. The Investors have the sole discretion and right to convert all or any portion of the then unpaid principal and interest balance of the Notes into shares of our Common Stock at a conversion price of $0.08 per share.
On the Change- in-Control Date, we entered into the Stock Purchase Agreement by and among our Company, NC 143 and RMI , pursuant to which NC 143 acquired 5,000,000 shares of our Common Stock for a purchase price of $400,000 and RMI acquired 4,000,000 shares of our Common Stock for a purchase price of $320,000, effective as of the Change-in-Control Date.
CPM Acquisition
On December 15, 2017, we entered into the CPM Acquisition Agreement with NC 143 pursuant to which we would purchase all of the outstanding membership interests of CPM as disclosed in our Current Report on Form 8-K, dated December 19, 2017, with the SEC, which is herein incorporated by reference.
On December 29, 2017, we completed the CPM Acquisition, pursuant to the CPM Acquisition Agreement. We issued 50 million shares of our Common Stock in exchange for 100% of the outstanding membership interests of CPM, at an agreed-upon value of $0.20 per share of Common Stock, as disclosed in our Current Report on Form 8-K, filed January 5, 2018 and amended by our Current Report on Form 8-K/A, dated March 12, 2018, which are both herein incorporated by reference. On the Effective Date and following the closing of the CPM Acquisition, NC 143 and RMI beneficially held approximately 90.4% of our Common Stock outstanding. Additional one-time costs incurred with the acquisition totaled approximately $200,000 and are included within selling, general, administrative and other expenses on the consolidated statement of operations.
Lease with 1565 North Central Expressway, LP
As disclosed in “Item 2. Properties” in this 2017 Annual Report, we lease an approximately 11,500 square-foot space as our principal executive office from NCE, LP, a real estate investment company that is owned and controlled by Mark W. Brooks, our Chairman of the Board and President. The CPM lease was effective January 1, 2013, and the Fuse lease was effective July 14, 2017. These leases terminated December 31, 2017, with month-to-month renewals, but we are in the process of renegotiating a lease renewal.
AmBio Contract
As disclosed in “Item 1. Business” and “Item 7. Management’s discussion and Analysis of Financial Condition and Results of Operations” in this 2017 Annual Report, AmBio provides us with payroll processing, employee benefit administration, and related human capital services to us effective January 1, 2017. Our Chairman of the Board and President, Mark Brooks, owns and controls AmBio. As of December 31, 2017, and 2016, we had balances due to AmBio of approximately $112,000. As of December 31, 2017, approximately $162,000 of fees were paid to AmBio for its services and are reflected with in selling, general, and administrative expenses on the accompanying consolidated statements of operations.
Operations
As previously disclosed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in this 2017 Annual Report, we have entered into various related-party transactions with entities that are owned by or affiliated with our Named Executive Officers and members of our Board. The transactions included sales, purchases, commissions paid for services, and revenues related to services provided to the related party.
MedUSA Group, LLC
MedUSA Group, LLC (“MedUSA”) is a sub-distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President, and Christopher C. Reeg, our Chief Executive Officer and Secretary.
During the years ended December 31, 2017, we had net sales of approximately $5,054,000 to MedUSA for products used in surgical cases.
During the years ended December 31, 2017, we incurred commission expense of approximately $962,000 to MedUSA for services provided to us in surgical cases.
As of December 31, 2017, we had balances due from MedUSA of approximately $1,684,000 included in accounts receivable on the accompanying consolidated balance sheets.
Texas Overlord, LLC
37
Texas Overlord, LLC (“Overlord”) is an investment holding company owned and controlled by Mark W. Brooks, our Chairman of the Board and President.
During the years ended December 31, 2017, we had net sales of approximately $1,953,000 to Overlord for product used in surgical cases.
During the years ended December 31, 2017, we incurred commission expense of approximately $101,000 respectively, to Overlord for services provided to us in surgical cases.
As of December 31, 2017, we had balances due from Overlord of approximately $444,000 included in accounts receivable on the accompanying consolidated balance sheets.
N.B.M.J., Inc.
N.B.M.J., Inc. (“NBMJ”) is a Durable Medical Equipment (“DME”) distributor and a wound care distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President.
During the years ended December 31, 2017, we had net sales of approximately $162,000 to NBMJ for product used in surgical cases.
During the years ended December 31, 2017 we incurred commission expense of approximately $0.00 to NBMJ for services provided to us in surgical cases.
Palm Springs Partners d/b/a Maxim Surgical, LLC
Palm Springs Partners d/b/a Maxim Surgical, LLC (“Maxim”) is a manufacturer/distributor owned and controlled by Christopher C. Reeg, our Chief Executive Officer and Secretary, and Mark W. Brooks, our Chairman of the Board and President.
During the year ending December 31, 2017, we had net sales of approximately $202,000 to Maxim for product used in surgical cases.
During the year ending December 31, 2017, we purchased approximately $596,000 from Maxim.
As of December 31, 2017, we had a balance due from Maxim of approximately $50,000, included in accounts receivable on the accompanying consolidated balance sheets. As of December 31, 2017, we had a balance due to Maxim of approximately $93,000, included in accounts payable on the accompanying consolidated balance sheets.
Sintu, LLC
Sintu, LLC (“Sintu”) is a sub-distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President. During the year ended December 31, 2017, we incurred commission expense of approximately $1,114,000 to Sintu for services provided in surgical cases.
Director Independence
We utilize the definition of “independent” set forth in the listing standards of NASDAQ. Currently, we believe that two of our directors Renato V. Bosita Jr., MD, MBA, and Ricky Raj S. Kalra, MD, are considered independent. All of our other directors are either executive officers, 5% beneficial owners, or both, of our Company and do not qualify as independent.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Our Board pre-approves audit and permissible non-audit services performed by our independent registered public accounting firm, as well as the fees charged for such services. All of the services related to audit fees and audit-related fees charged by Montgomery Coscia Greilich, LLP (“MCG”), and Weinberg and Company, (“Weinberg”) if any, were pre-approved by our Board. The following table shows the fees for the years ended December 31, 2017 and 2016.
38
|
(1) |
Audit fees consisted principally of services related to our assurance and related services by our principal accountant that are reasonably related to the performance of the audit or review of our annual and quarterly financial statements as well as the review of our registration statements. We engaged MCG and Weinberg for 2017 and 2016, respectively. |
|
(2) |
The Audit fees for 2017 include a one-time cost associated with the CPM Acquisition. |
|
(3) |
On November 16, 2017, we appointed LaPorte CPAs and Business Advisors (“LaPorte”) as our independent registered public accounting firm for the fiscal year ended December 31, 2017, as reported in our Current Report on Form 8-K, filed with the SEC on November 21, 2017, which is herein incorporated by reference. However, on January 5, 2018, we accepted the resignation of LaPorte as our independent registered public accounting firm and appointed MCG as our independent registered public accounting firm, as reported in our Current Report on Form 8-K, filed with the SEC on January 11, 2018, which is herein incorporated by reference. We paid no fees to LaPorte. |
39
ITEM 15. EXHIBITS AND FINANCIAL STATEMENTS SCHEDULES.
(a) |
Documents filed as part of the report. |
|
(1) |
Financial Statements. See Index to Consolidated Financial Statements, which appears on page F-1 hereof. The financial statements listed in the accompanying Index to Consolidated Financial Statements are filed herewith in response to this Item. |
|
(2) |
Financial Statements Schedules. All schedules are omitted because they are not applicable or because the required information is contained in the consolidated financial statements or notes included in this report. |
|
(3) |
Exhibits. The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this report. |
(b) |
Exhibits. |
Exhibit No. |
|
Description |
|
|
|
2.1 |
|
|
|
|
|
2.2 |
|
|
|
|
|
2.3 |
|
|
|
|
|
3.1 |
|
|
|
|
|
3.2 |
|
|
|
|
|
3.3 |
|
|
|
|
|
3.4 |
|
|
|
|
|
3.5 |
|
|
|
|
|
4.1* |
|
|
|
|
|
4.2 |
|
|
|
|
|
4.3 |
|
|
|
|
|
4.4 |
|
|
|
|
|
4.5 |
|
|
|
|
|
40
Exhibit No. |
|
Description |
|
|
|
4.6 |
|
Promissory Note dated October 19, 2016 payable to NC 143 Family Holdings, LP from the Company in the amount of $50,000.00 (filed as Exhibit 10.33 to the Company’s Form 10-K filed March 20, 2017 and incorporated herein by reference ). |
|
|
|
4.7 |
|
|
|
|
|
4.8 |
|
|
|
|
|
10.1 |
|
|
|
|
|
10.2 |
|
|
|
|
|
10.3 |
|
|
|
|
|
10.4* |
|
|
|
|
|
10.5* |
|
|
|
|
|
10.6* |
|
|
|
|
|
10.7* |
|
|
|
|
|
10.8* |
|
|
|
|
|
10.9* |
|
|
|
|
|
10.10* |
|
|
|
|
|
10.11* |
|
|
|
|
|
10.12* |
|
|
|
|
|
10.13* |
|
|
|
|
|
10.14* |
|
|
|
|
|
10.15 |
|
|
|
|
|
10.16 |
|
|
|
|
|
41
Exhibit No. |
|
Description |
|
|
|
10.17 |
|
Sublease Agreement dated September 1, 2015, by and between Fuse Medical, Inc. and PHILLIP GALYEN, PC, d/b/a Bailey & Galyen (filed as Exhibit 10.3 to the Company’s Form 8-K, filed on July 19, 2017, and incorporated herein by reference). |
|
|
|
10.18 |
|
|
|
|
|
10.19* |
|
|
|
|
|
10.20 |
|
|
|
|
|
10.21 |
|
|
|
|
|
10.22 |
|
|
|
|
|
10.23 |
|
|
|
|
|
10.24 |
|
|
|
|
|
10.25 |
|
|
|
|
|
21.1* |
|
|
|
|
|
31.1* |
|
|
|
|
|
31.2* |
|
|
|
|
|
32.1* |
|
|
|
|
|
101.INS * |
|
XBRL Instance Document |
|
|
|
101.SCH * |
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL * |
|
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF * |
|
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB * |
|
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE * |
|
XBRL Taxonomy Extension Presentation Linkbase Document |
* Filed Herewith
42
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
|
|
FUSE MEDICAL, INC. |
|
|
|
Date: April 5, 2018 |
By: |
/s/ Christopher C. Reeg |
|
|
Christopher C. Reeg |
|
|
Chief Executive Officer and Director |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Date: April 5, 2018 |
By: |
/s/ Christopher C. Reeg |
|
|
Christopher C. Reeg |
|
|
Chief Executive Officer and Director (Principal Executive Officer) |
Date: April 5, 2018 |
By: |
/s/ William E. McLaughlin, III |
|
|
William E. McLaughlin, III |
|
|
Chief Financial Officer and Director (Principal Financial Officer) |
Date: April 5, 2018 |
By: |
/s/ Mark W. Brooks |
|
|
Mark W. Brooks President, Director, and Chairman of the Board |
Date: April 5, 2018 |
By: |
/s/ Ricky Raj S. Kalra |
|
|
Ricky Raj S. Kalra, MD Director |
Date: April 5, 2018 |
By: |
/s/ Renato V. Bosita, Jr. |
|
|
Renato V. Bosita, Jr., MD Director |
43
F-1
REPORT OF INDEPENDENT REGIS TERED PUBLIC ACCOUNTING FIRM
The shareholders and the board of directors of Fuse Medical, Inc. and Subsidiary
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Fuse Medical, Inc. and Subsidiary (the "Company") as of December 31, 2017 and 2016, and the related consolidated statements of operations, changes in stockholders’ equity (deficit) and cash flows for the years in the two-year period ended 2017 and 2016, and the related notes and schedules (collectively referred to as the financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2017 and 2016, and the results of its operations and its cash flows for each of the years in the two-year period ended 2017 and 2016, in conformity with generally accepted accounting principles in the United States of America (“GAAP”).
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board in the United States (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits include performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Montgomery Coscia Greilich, LLP
We have served as the Company’s auditor since 2018.
Plano, Texas
F-2
FUSE MEDICAL, INC. AND SUBSIDIARY
|
|
December 31, 2017 |
|
|
December 31, 2016 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
804,715 |
|
|
$ |
778,447 |
|
Accounts receivable, net of allowance of $499,099 and $1,682,995, respectively |
|
|
6,570,382 |
|
|
|
6,508,286 |
|
Inventories, net of allowance of $1,110,742 and $1,134,013, respectively |
|
|
10,626,769 |
|
|
|
11,426,828 |
|
Prepaid expenses and other current assets |
|
|
32,466 |
|
|
|
23,018 |
|
Total current assets |
|
|
18,034,332 |
|
|
|
18,736,579 |
|
Property and equipment, net |
|
|
16,895 |
|
|
|
14,747 |
|
Security deposit |
|
|
- |
|
|
|
3,822 |
|
Deferred tax asset |
|
|
375,278 |
|
|
|
|
|
Goodwill |
|
|
820,650 |
|
|
|
820,650 |
|
Total assets |
|
$ |
19,247,155 |
|
|
$ |
19,575,798 |
|
Liabilities and Stockholders' Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,588,091 |
|
|
$ |
2,452,922 |
|
Accrued expenses |
|
|
1,830,679 |
|
|
|
3,068,054 |
|
Notes payable - related parties |
|
|
150,000 |
|
|
|
150,000 |
|
Revolving line of credit |
|
|
3,415,351 |
|
|
|
3,305,347 |
|
Total current liabilities |
|
|
7,984,121 |
|
|
|
8,976,323 |
|
Earn-out liability |
|
|
19,244,543 |
|
|
|
- |
|
Total liabilities |
|
|
27,228,664 |
|
|
|
8,976,323 |
|
Commitments and contingencies |
|
|
- |
|
|
|
- |
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; 20,000,000 shares authorized; no shares issued and outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $0.01 par value; 100,000,000 shares authorized; 69,158,308 issued and 65,890,808 outstanding at December 31, 2017 and 15,890,808 issued and outstanding at December 31, 2016 |
|
|
671,583 |
|
|
|
158,908 |
|
Additional paid-in capital |
|
|
(8,653,092 |
) |
|
|
10,440,567 |
|
Retained earnings |
|
|
- |
|
|
|
- |
|
Total stockholders’ equity (deficit) |
|
|
(7,981,509 |
) |
|
|
10,599,475 |
|
Total liabilities and stockholders’ equity (deficit) |
|
$ |
19,247,155 |
|
|
$ |
19,575,798 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-3
FUSE MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in dollars, except per share data) |
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Net revenues |
|
$ |
26,407,206 |
|
|
$ |
25,666,650 |
|
Cost of revenues |
|
|
14,582,416 |
|
|
|
11,256,887 |
|
Gross profit |
|
|
11,824,790 |
|
|
|
14,409,763 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Selling, general, administrative and other |
|
|
5,356,475 |
|
|
|
4,170,835 |
|
Commissions |
|
|
5,641,122 |
|
|
|
7,056,430 |
|
Gain on disposal of property and equipment |
|
|
(5,367 |
) |
|
|
- |
|
Depreciation |
|
|
14,521 |
|
|
|
19,091 |
|
Total operating expenses |
|
|
11,006,751 |
|
|
|
11,246,356 |
|
Operating income |
|
|
818,039 |
|
|
|
3,163,407 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(161,669 |
) |
|
|
(146,921 |
) |
Extinguishment of debt |
|
|
43,308 |
|
|
|
— |
|
Total other income (expense) |
|
|
(118,361 |
) |
|
|
(146,921 |
) |
Net income |
|
$ |
699,678 |
|
|
$ |
3,016,486 |
|
Net income per common share - basic |
|
$ |
0.04 |
|
|
$ |
0.42 |
|
Net income per common share - diluted |
|
$ |
0.04 |
|
|
$ |
0.33 |
|
Weighted average number of common shares outstanding - basic |
|
|
16,027,794 |
|
|
|
7,185,890 |
|
Weighted average number of common shares outstanding - diluted |
|
|
19,473,553 |
|
|
|
9,214,606 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-4
FUSE MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Retained |
|
|
|
|
|
|||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Earnings |
|
|
Total |
|
|||||
Balance, December 31, 2015 (successor) |
|
|
6,890,808 |
|
|
$ |
68,908 |
|
|
$ |
7,929,234 |
|
|
$ |
- |
|
|
$ |
7,998,142 |
|
Member contribution (successor) |
|
|
- |
|
|
|
- |
|
|
|
775,949 |
|
|
|
- |
|
|
|
775,949 |
|
Member distribution (successor) |
|
|
- |
|
|
|
- |
|
|
|
(2,346,859 |
) |
|
|
(134,319 |
) |
|
|
(2,481,178 |
) |
Fuse capital, net |
|
|
9,000,000 |
|
|
|
90,000 |
|
|
|
4,082,243 |
|
|
|
(2,882,167 |
) |
|
|
1,290,076 |
|
Net income |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,016,486 |
|
|
|
3,016,486 |
|
Balance, December 31, 2016 |
|
|
15,890,808 |
|
|
|
158,908 |
|
|
|
10,440,567 |
|
|
|
- |
|
|
|
10,599,475 |
|
Restricted stock awards granted |
|
|
3,267,500 |
|
|
|
12,675 |
|
|
|
29,934 |
|
|
|
- |
|
|
|
42,609 |
|
Purchase of CPM Medical Consultants, LLC |
|
|
50,000,000 |
|
|
|
500,000 |
|
|
|
(19,744,543 |
) |
|
|
- |
|
|
|
(19,244,543 |
) |
Deferred tax asset |
|
|
- |
|
|
|
- |
|
|
|
375,278 |
|
|
|
- |
|
|
|
375,278 |
|
Member contribution (successor) |
|
|
- |
|
|
|
- |
|
|
|
1,738,620 |
|
|
|
- |
|
|
|
1,738,620 |
|
Member distribution (successor) |
|
|
- |
|
|
|
- |
|
|
|
(1,492,948 |
) |
|
|
(699,678 |
) |
|
|
(2,192,626 |
) |
Net income |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
699,678 |
|
|
|
699,678 |
|
Balance, December 31, 2017 |
|
|
69,158,308 |
|
|
$ |
671,583 |
|
|
$ |
(8,653,092 |
) |
|
$ |
- |
|
|
$ |
(7,981,509 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-5
FUSE MED ICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
699,678 |
|
|
$ |
3,016,486 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Amortization of debt discount |
|
|
- |
|
|
|
13,094 |
|
Share-based compensation |
|
|
42,609 |
|
|
|
- |
|
Depreciation |
|
|
14,521 |
|
|
|
19,091 |
|
Gain on disposal of property and equipment |
|
|
(5,067 |
) |
|
|
- |
|
Extinguishment of debt |
|
|
(43,308 |
) |
|
|
- |
|
Bad debt expense |
|
|
- |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(62,096 |
) |
|
|
995,785 |
|
Inventories, net |
|
|
2,022,723 |
|
|
|
(139,993 |
) |
Prepaid expenses and other current assets |
|
|
(9,448 |
) |
|
|
107 |
|
Security deposit |
|
|
3,822 |
|
|
|
- |
|
Accounts payable |
|
|
178,477 |
|
|
|
(1,313,409 |
) |
Accrued expenses |
|
|
(1,236,527 |
) |
|
|
199,177 |
|
Deferred rent |
|
|
(848 |
) |
|
|
- |
|
Net cash provided by operating activities |
|
|
1,604,536 |
|
|
|
2,790,338 |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(20,334 |
) |
|
|
- |
|
Insurance settlement proceeds |
|
|
8,732 |
|
|
|
- |
|
Proceeds from reverse acquisition |
|
|
- |
|
|
|
655,390 |
|
Net cash (used in) provided by investing activities |
|
|
(11,602 |
) |
|
|
655,390 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments on line of credit |
|
|
(15,580,346 |
) |
|
|
(14,118,720 |
) |
Borrowings on line of credit |
|
|
15,690,350 |
|
|
|
13,208,210 |
|
Member contributions (successor) |
|
|
273,044 |
|
|
|
375,210 |
|
Member distributions (successor) |
|
|
(1,949,714 |
) |
|
|
(2,395,606 |
) |
Net cash used in financing activities |
|
|
(1,566,666 |
) |
|
|
(2,930,906 |
) |
Net increase in cash and cash equivalents |
|
|
26,268 |
|
|
|
514,822 |
|
Cash and cash equivalents - beginning of year |
|
|
778,447 |
|
|
|
263,625 |
|
Cash and cash equivalents - end of year |
|
$ |
804,715 |
|
|
$ |
778,447 |
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
139,507 |
|
|
$ |
150,762 |
|
Supplemental disclosure of noncash operating and financing activities: |
|
|
|
|
|
|
|
|
Member contributions through reduction of accounts payable |
|
$ |
- |
|
|
|
25,000 |
|
Member contributions of inventory |
|
$ |
1,465,576 |
|
|
|
375,739 |
|
Member distributions of inventory |
|
$ |
242,912 |
|
|
|
85,572 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-6
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Overview
The Company was initially incorporated in 1968 as Golf Rounds.com, Inc., a Florida corporation. During July 1999, GolfRounds, Inc. was re-domesticated to Delaware through a merger into its wholly-owned subsidiary GolfRounds.com, Inc. Effective May 28, 2014, GolfRounds.com, Inc. amended its certificate of incorporation to change its name to Fuse Medical, Inc. (“Fuse”) and merged with and into Fuse Medical, LLC, with Fuse Medical, LLC surviving as a wholly-owned subsidiary of Fuse. The transaction was accounted for as a reverse merger with Fuse the legal acquirer, and Fuse Medical, LLC deemed the accounting acquirer (“Reverse Merger”). During 2015, certificates of termination were filed for Fuse Medical, LLC and its two subsidiaries.
Change in Control
Between the period July 2016 through October 2016, the Company obtained three loans in the aggregate amount of $150,000 in exchange for convertible promissory notes (the “Notes”) bearing 10% interest per annum, with principal due and payable, upon demand of the payee. The Notes were issued as follows: $100,000 to NC 143 Family Holdings, LP, a family limited partnership controlled by Mark W. Brooks (“NC 143”), the Company’s Chairman of the Board of Directors (the “Board”); and $50,000 to Reeg Medical Industries, Inc., an investment holding company owned and controlled by Christopher C. Reeg, the Company’s Chief Executive Officer (“RMI”, and together with NC 143, the “Investors”). The Investors have the sole discretion and right to convert all or any portion of the then unpaid principal and interest balance of the Notes into shares of the Company’s common stock at a conversion price of $0.08 per share.
On December 19, 2016 (the “Change-in-Control Date”), the Company entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) by and between the Investors and the Company, pursuant to which NC 143 acquired 5 million shares of the Company’s common stock for a purchase price of $400,000 and RMI acquired 4 million shares of the Company’s common stock for a purchase price of $320,000 (collectively the “Investor Shares”), effective as of the Change-in-Control Date. Direct offering costs of the Company were $64,609 in connection with the offer and sale of the Investor Shares, and, net proceeds from the offer and sale of the Investor Shares were $655,391.
CPM Acquisition
On December 15, 2017, Fuse entered into an agreement with NC 143 pursuant to which Fuse would purchase all of the outstanding membership interests of CPM Medical Consultants, LLC (“CPM”) (the “CPM Acquisition Agreement” and such transaction, the “CPM Acquisition”).
On December 29, 2017, Fuse completed the previously-announced the CPM Acquisition, pursuant to the CPM Acquisition Agreement by Fuse and NC 143, dated December 15, 2017, whereby the Fuse would purchase all of the outstanding membership interests of CPM. Fuse issued 50 million shares of its common stock, par value $0.01 per share in exchange for 100% of the outstanding membership interests of CPM, at an agreed-upon value of $0.20 per share of common stock. The effective date of the CPM acquisition was December 31, 2017 (the “Effective Date”). The CPM Acquisition provides for contingent payments, (Earn-Out”) to NC 143 subject to certain sales and profitability targets being met by the Company for years after 2017.
Fuse was the legal acquirer and, for accounting purposes, CPM was deemed to have acquired our Company in the CPM Acquisition. CPM is the successor entity and becomes the reporting entity which combines Fuse at the Change-in-Control Date, with the assets and liabilities of both companies combined at historical cost. (see note 3)
Nature of Business
Fuse is a national distributor of medical devices, who provides a broad portfolio of internal and external fixation products; upper and lower extremity plating and total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; spinal implants for trauma, degenerative disc disease, and deformity indications (collectively, “Orthopedic Implants”) and a wide array of osteo-biologics and regenerative tissue which include human allografts, substitute bone materials and tendons, as well as regenerative tissues and fluids (“Biologics”). All of our medical devices are approved by the U.S. Food and Drug Administration (“FDA”) for sale in the United States, and all of our Biologics suppliers are licensed tissue banks accredited by the American Association of Tissue Banks (“AATB”).
F-7
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
The Company’s board portfolio of Orthopedic Implants and Biologics provide high-quality products to assist surgeons with positive patient outcomes and cost - effective solutions for its customers , which include hospitals, medical facilities, and sub-distributors. Fuse operates under exclusive and non-exclusive agreements with certain vendors and supply partners in the geographic territories the Company serves.
Fuse continuously reviews and expands its product lines to ensure that they offer the most comprehensive, high-quality and cost-effective selection of Orthopedic Implants and Biologics so that the Company can be more relevant to its customer needs while continuing to grow its existing customer base.
Note 2. Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany transactions have been eliminated in consolidation.
Use of Estimates
The preparation of the consolidated financial statements in accordance with generally accepted accounting principles in the United State, (“GAAP”). GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts in the consolidated financial statements. Actual results could differ from those estimates. Significant estimates in the accompanying consolidated financial statements include the allowances for doubtful accounts and contractual pricing, valuation of inventories, accrued commissions, the fair value calculation of stock based compensation, and fair value of Earn-Out liability.
Earnings Per Share
Basic net income per common share is calculated by dividing net income attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Shares of restricted stock are included in the basic weighted average number of common shares outstanding from the time they vest. Diluted net income per common share is computed by dividing net income attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury stock method. As of December 31, 2017, 700,000 outstanding common stock equivalents have been included with diluted net earnings per share.
As of December 31, 2017, and 2016, common stock equivalents included options to purchase 1,302,052 and 1,304,788 common shares, respectively.
Fair Value Measurements
Fair value is the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants. The Company classifies assets and liabilities recorded at fair value under the fair value hierarchy based upon the observability of inputs used in valuation techniques. Observable inputs (highest level) reflect market data obtained from independent sources, while unobservable inputs (lowest level) reflect internally developed market assumptions. The fair value measurements are classified under the following hierarchy:
Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets and liabilities in active markets;
Level 2—Observable inputs, other than quoted market prices, that are either directly or indirectly observable in the marketplace for identical or similar assets and liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities; and
Level 3—Unobservable inputs that are supported by little or no market activity that are significant to the fair value of assets or liabilities.
In connection with the CPM Acquisition, the Company recorded a $19,244,543 liability related to the Earn-Out portion of the purchase consideration. See Note 3, Acquisition, for further discussion of the Earn-Out liability. The Company has classified the Earn-Out liability as a Level 3 liability and the fair value of the Earn-Out liability will be evaluated each reporting period and changes in its
F-8
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
fair value will be included in the Company’s results of operations. The fair value of the Earn-Out liability was calculated using a discount rate, approximating the pre-tax cost of debt and cor roborated by Monte Carlo simulation, which was then applied to estimated Earn-Out payments. To determine the fair value of the Earn-Out liability, the Company’s management evaluates assumptions that require significant judgment. Changes in certain inputs t o the valuation model, including the Company’s management’s estimate of future revenues, can have a significant impact on the estimated fair value. The fair value recorded for the Earn-Out liability may vary significantly from period to period. This variab ility may result in the actual liability for a period either above or below the estimates recorded in the Company’s consolidated financial statements, resulting in adjustments to the Earn-Out liability with a corresponding non-cash gain or loss recorded to additional paid-in capital.
The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The recorded value of notes payable approximates their fair value based upon their effective interest rates.
Cash and Cash Equivalents
The Company considers highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. There were no cash equivalents at December 31, 2017 and 2016. The Company’s cash is concentrated in large financial institutions that at times may exceed federally insured limits of $250,000 per financial institution. The Company has not experienced any losses from inception through December 31, 2017. As of December 31, 2017, and 2016, there were deposits of $537,388 and $421,636 , respectively, greater than federally insured limits.
Accounts Receivable and Allowances
Accounts receivables are non-interest bearing and are stated at gross invoice amounts less an allowance for doubtful accounts receivable and an allowance for contractual pricing. Credit is extended to customers based on an evaluation of their financial condition and other factors. The Company generally does not require collateral or other security to support accounts receivable. The Company performs ongoing credit evaluations of its customers and maintains an allowance for potential bad debts.
The Company estimates its allowance for doubtful accounts by evaluating specific accounts where information indicates the customers may have an inability to meet financial obligations, such as bankruptcy proceedings and receivable amounts outstanding for an extended period beyond contractual terms. In these cases, the Company uses assumptions and judgment, based on the best available facts and circumstances, to record a specific allowance for those customers against amounts due to reduce the receivable to the amount expected to be collected. These specific allowances are re-evaluated and adjusted as additional information is received. The amounts calculated are analyzed to determine the total amount of the allowance. The Company may also record a general allowance as necessary.
The Company’s management estimates its allowance for contractual pricing, by evaluating specific accounts where information indicates the customer is offered contractual pricing and discount allowances. In these arrangements, the Company’s management uses assumptions and judgement, based on the best available facts and circumstances to record a specific allowance for the amounts due from those customers. The allowance is offset by a corresponding reduction to revenue. These specific allowances are re-evaluated and adjusted as additional information is received. The amounts calculated are analyzed to determine the total amount of the allowance. The Company may also record a general allowance as necessary.
Accounts deemed uncollectible are written-off in the period when the Company has exhausted its efforts to collect overdue and unpaid receivables or otherwise has evaluated other circumstances that indicate that the Company should abandon such efforts. Previously written-off accounts receivable subsequently collected are recognized as a reduction of bad debt expense when funds are received.
Inventories
Inventories are stated at the net realizable value (first-in, first-out). Inventories consist entirely of finished goods and include Orthopedic Implants and Biologics. The Company reviews the market value of inventories whenever events and circumstances indicate that the carrying value of inventories may not be recoverable from the estimated future sales price less cost of disposal and normal gross profit. In cases where the market values are less than the carrying value, a write-down is recognized equal to an amount by which the carrying value exceeds the market value of inventories.
F-9
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Property and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the related assets per the following table. Leasehold improvements are amortized over the lesser of their useful life or the lease term. Expenditures for additions and improvements are capitalized while repairs and maintenance are expensed as incurred.
Upon the retirement or disposition of property and equipment, the related cost and accumulated depreciation and amortization are removed and a gain or loss is recorded in the consolidated statements of operations.
The Company assesses potential impairment to its long-lived assets when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Events and circumstances considered by the Company in determining whether the carrying value of identifiable intangible assets and other long-lived assets may not be recoverable include, but are not limited to: (i) significant changes in performance relative to expected operating results, (ii) significant changes in the use of the assets, (iii) significant negative industry or economic trends, (iv) a significant decline in the Company’s stock price for a sustained period of time, and (v) changes in the Company’s business strategy. An impairment loss is recorded when the carrying amount of the long-lived asset is not recoverable and exceeds its fair value. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. Any required impairment loss is measured as the amount by which the carrying amount of a long-lived asset exceeds fair value and is recorded as a reduction in the carrying value of the related asset and an expense to operating results. Based upon the Company’s assessment, there were no indicators of impairment of its long-lived assets at December 31, 2017 and 2016.
Goodwill
Goodwill is the excess of the purchase price over the fair value of net assets of acquired businesses. Goodwill is tested for impairment annually or whenever an event occurs or circumstances change that would indicate that the carrying amount may be impaired. The test for impairment requires us to make several estimates about fair value, most of which are based on projected future cash flows. The Company’s management estimates associated with the goodwill impairment test are considered critical due to the amount of goodwill recorded on our consolidated balance sheets and the judgment required in determining fair value, including projected future cash flows. No goodwill impairment has been recognized during 2017 or 2016.
Revenue Recognition
The Company recognizes revenue when: (i) persuasive evidence of an arrangement exists; (ii) the fees are fixed or determinable; (iii) no significant Company obligations remain; and (iv) collection of the related receivable is reasonably assured. The Company reports revenues for transactions in which it is the primary obligor on a gross basis and revenues in which it acts as an agent (earning a fixed percentage of the sale) on a net basis, (net of related costs). The Company reports funds collected from customers as deferred revenues until all revenue recognition criteria have been met.
Revenues are sales of Orthopedic Implants and Biologics to support orthopedic surgeries and wound care . For customers that purchase products as needed, the Company invoices the customers on the date the product is utilized. For customers that have consigned product, the Company invoices the customers as each unit of the product is utilized. Payment terms are due upon receipt of invoice.
Products that have been sold are not subject to returns unless the product is deemed defective. Credits or refunds are recognized when they are determinable and estimable. Net revenues have been reduced to account for sales returns, discounts and other incentives.
F-10
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Cost of revenues consists of cost of goods sold, freight and shipping costs for items sold to customers, cost of storage, and related supply chain costs.
Shipping and Handling Fees
The Company includes shipping and handling fees billed to customers in revenues and the related costs in cost of revenues.
Income Taxes
As a result of the CPM Acquisition, Fuse became the sole managing member of CPM and as a result, began consolidating the financial results of CPM. CPM is treated as a partnership for U.S. federal and most applicable state and local income tax purposes. As a partnership, CPM is not subject to U.S. federal and most applicable state and local income tax purposes. As a partnership, CPM is not subject to U.S. federal and certain state and local income taxes. Any taxable income or loss generated by CPM is passed through to an included in the taxable income or loss of its members.
The Company uses the asset and liability method to compute the differences between the tax basis of assets and liabilities and the related financial amounts. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount that more likely than not will be realized. The Company has deferred tax assets and liabilities that reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Deferred tax assets are subject to periodic recoverability assessments. Realization of the deferred tax assets, net of deferred tax liabilities, is principally dependent upon achievement of projected future taxable income.
The Company records a liability for uncertain tax positions when it is probable that a loss has been incurred and the amount can be reasonably estimated. As of December 31, 2017, the Company had no liabilities for uncertain tax positions. The Company's policy is to recognize interest and penalties related to income tax matters as a component of income tax expense. The Company continually evaluates expiring statutes of limitations, audits, proposed settlements, changes in tax law, and new authoritative rulings.
Segment Information
The Company operates in one reportable segment including medical products and supplies. The Company's chief operating decision maker, is its Chief Executive Officer. The Company’s Chief Executive Officer manages the Company's operations as a whole, and does not evaluate revenue, expense or operating income information on any component level.
Stock-Based Compensation
Stock-based compensation expense is measured at the grant date fair value of the award and is expensed over the requisite service period. For employee stock-based awards, the Company calculates the fair value of the award on the date of grant using the Black-Scholes option pricing model. Determining the fair value of stock-based awards at the grant date under this model requires judgment, including estimating volatility, employee stock option exercise behaviors and forfeiture rates. The assumptions used in calculating the fair value of stock-based awards represent the Company's best estimates, but these estimates involve inherent uncertainties and the application of management judgment. For non-employee stock-based awards, the Company calculates the fair value of the award on the date of grant in the same manner as employee awards, however, the awards are revalued at the end of each reporting period and the prorata compensation expense is adjusted accordingly until such time the non-employee award is fully vested, at which time the total compensation recognized to date shall equal the fair value of the stock-based award as calculated on the measurement date, which is the date at which the award recipient’s performance is complete. The estimation of stock-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers”. ASU 2014-09 is a comprehensive revenue recognition standard that will supersede nearly all existing revenue recognition guidance under current GAAP and replace it with a principle-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for interim and annual periods beginning after December 15,
F-11
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
2017. Early adoption is permitted only in annual reporting periods beginning after December 15, 2016, including interim periods therein. Entities will be able to transition to the standard e ither retrospectively or as a cumulative-effect adjustment as of the date of adoption. The Company ’s management is in the process of evaluating the impact of ASU 2014-09 on the Company's financial statements and disclosures.
In July 2015, the FASB issued ASU No. 2015-11 — “Inventory (Topic 330)”, which requires an entity to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company adopted ASU 2015-11 as of January 1, 2017 and did not have a material impact on the Company’s financial statements.
In February 2016, the FASB issued Accounting Standards Update No. 2016-02, “Leases”, which requires a lessee to record a right of use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018. Early adoption is permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company’s management is in the process of evaluating the impact of the adoption of ASU 2016-02 on the Company's financial statements and disclosures.
In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash payments.” The update addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. This ASU is effective for the public business entities for fiscal years beginning after December 15, 2017 and for interim periods within those fiscal years. The amendments in this update may be applied retrospectively or prospectively and early adoption is permitted. The Company’s management is in the process of evaluating the impact of ASU 2016-15 on the Company’s financial statements and disclosures.
In November 2016, the FASB issued ASU Update No. 2016-18 — “Statement of Cash Flows (Topic 230): Restricted Cash (A Consensus of the FASB EITF)”. ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. These amounts should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. This amendment does not provide a definition of restricted cash or restricted cash equi valents. The update will be effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. The Company’s management is in the process of evaluating the impact of ASU 2016-18 on the Company’s financial statements and disclosures.
Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission, (the “SEC”) did not or are not believed by management to have a material impact on the Company's present or future consolidated financial statements.
F-12
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Between the period July 2016 through October 2016, the Company obtained three loans in the aggregate amount of $150,000 in exchange for the Notes bearing 10% interest per annum, with principal due and payable, upon demand of the payee. The Notes were issued as follows: $100,000 to NC 143, and $50,000 to RMI. The Investors have the sole discretion and right to convert all or any portion of the then unpaid principal and interest balance of the Notes into shares of the Company’s common stock at a conversion price of $0.08 per share. (see note 6).
On December 19, 2016, the Company entered into a Stock Purchase Agreement by and between the Investors and the Company, pursuant to which NC 143 acquired 5 million shares of the Company’s common stock for a purchase price of $400,000 and RMI acquired 4 million shares of the Company’s common stock for a purchase price of $320,000 effective as of the Change-in-Control Date. Direct offering costs of the Company were $64,609 in connection with the offer and sale of the Investor Shares, and, net proceeds from the offer and sale of the Investor Shares were $655,391.
The closing of the Stock Purchase Agreement resulted in a change-in-control of the Company whereby the Investors beneficially acquired approximately 61.4% of the Company’s common stock issued and outstanding immediately after the Change-in-Control Date. Mark W. Brooks became our Chairman of the Board and Christopher C. Reeg became our Chief Executive Officer, as described in our Current Report on Form 8-K, filed with the Commission on December 23, 2016, which is herein incorporated by reference. Fuse recorded a goodwill asset of $820,000 to reflect the excess of the carrying value of the Company’s net assets over their fair value as implied by the purchase price paid by the Investors on the Change-in-Control Date.
On December 15, 2017, Fuse entered into the CPM Acquisition Agreement with NC 143 pursuant to which Fuse would purchase all of the outstanding membership interests of CPM.
On December 29, 2017, Fuse completed the previously-announced CPM Acquisition, pursuant to the CPM Acquisition Agreement by Fuse and NC 143, dated December 15, 2017, whereby Fuse would purchase all of the outstanding membership interests of CPM. Fuse issued 50 million shares of its common stock, par value $0.01 per share in exchange for 100% of the outstanding membership interests of CPM, at an agreed-upon value of $0.20 per share of common stock. The effective date of the CPM Acquisition was December 31, 2017. Additional one-time costs incurred with the acquisition totaled approximately $200,000 and are included in the selling, general, administrative and other expenses on the consolidated statements of operations.
The CPM Acquisition Agreement provides for Earn-Out payments to NC 143 subject to certain sales and profitability targets being met by the Company for years after 2017. The fair value of the Earn-Out was recorded at $19,244,543 as of the Effective Date. The Company recorded the Earn-Out at its fair value of the Effective Date. The CPM Acquisition Agreement provides for a working capital post-closing adjustment (“Post-Closing Adjustment”) for certain changes in CPMs current assets and current liabilities pursuant to the CPM Acquisition Agreement. The Post-Closing Adjustment is approximately $397,463 and will be paid in shares of the Company’s common stock within 120 days the Effective Date.
On the Effective Date of the closing of the CPM acquisition, NC 143 and RMI beneficially acquired approximately 90.4% of the Company’s common stock outstanding.
Fuse is the legal acquirer and, for accounting purposes, CPM was deemed to have acquired the Company in the CPM Acquisition. CPM is the successor entity and becomes the reporting entity which combines Fuse at the Change-in-Control Date, with the assets and liabilities of both companies combined at historical cost. (see note 1).
The following unaudited pro forma summary financial information presents the consolidated results of operations for the Company as if the CPM Acquisition had occurred on January1, 2016. The pro forma results are shown for illustrative purposes only and do not purport to be indicative of the results that would have been reported if the CPM Acquisition had occurred on the date indicated or indicative of the results that may occur in the future.
F-13
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Unaudited pro forma information for the twelve mo nths ended December 31, 2016 is as follows:
|
Year Ended December 31, 2016 - Unaudited |
|
|||||||||||||
|
Historical Fuse Medical, Inc. |
|
|
Historical CPM Medical Consultants, LLC |
|
|
Pro forma Adjustments |
|
|
Pro forma Combined |
|
||||
Revenue |
$ |
567,607 |
|
|
$ |
25,647,353 |
|
|
$ |
(103,578 |
) |
|
$ |
26,111,382 |
|
Net (loss) income |
$ |
(585,935 |
) |
|
$ |
3,035,296 |
|
|
$ |
- |
|
|
$ |
2,449,361 |
|
Net (loss) income per common share - basic |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
0.34 |
|
The supplemental pro forma earnings were adjusted to exclude $103,578 for the year ended December 31, 2016. The number of shares outstanding used in calculating the net (loss) per common share – basic was 7,185,890 for the year ended December 31, 2016.
The Company is managed and operates in one segment, with Fuse merged into the CPM existing operations.
Note 4. Property and Equipment
Property and equipment consisted of the following at December 31, 2017 and 2016:
During the year ended December 31, 2017, the Company sold fixed assets having a net book value of $607 for cash proceeds of $300, retired fixed assets no longer in use with a net book value of $3,058, and recorded $8,732 of insurance settlements proceeds for a fully depreciated fixed asset.
Depreciation expense for the years ended December 31, 2017 and 2016 was $14,521 and $19,091, respectively.
F-14
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Note 5. Revolving Line of Credit
On December 29, 2017, Fuse became party to a revolving line of credit (“RLOC”) with ZB, N.A. (d/b/a Amegy Bank), to facilitate the December 31, 2017 CPM Acquisition. The RLOC establishes an asset based senior secured revolving credit facility in the amount of $5,000,000. The RLOC bears interest at a variable rate based on the one-month LIBOR rate plus 3.00% (effective rate of 4.56% at December 31, 2017). The RLOC contains customary representation, warranties, covenants, events of default, and is collateralized by substantially all of the Company’s assets. The Chairman of the Board personally guarantees fifty percent (50%) of the outstanding loan amount.
The outstanding balance of the RLOC was $3,415,351 and $3,305,347 at December 31, 2017 and 2016, respectively. Interest expense incurred was $134,668 and $133,334 for 2017 and 2016, respectively.
Note 6. Notes Payable – Related Parties
During July 2016 through October 2016, the Company obtained three short-term loans in the aggregate amount of $150,000 in exchange for promissory notes bearing 10% interest per annum, which principal shall be due and payable, upon demand of the payee. Notwithstanding, at the holder’s sole discretion, the holder has the right to convert all or any portion of the then unpaid principal and interest balance into shares of the Company’s common stock at a conversion price of $0.08 per share. On each respective date of issuance, the conversion price of each of the promissory notes was less than the market price of the Company’s common stock. This resulted in a beneficial conversion feature in the aggregate amount of $117,500, which was treated as a discount to each of the promissory notes and amortized over the term of each respective promissory note. Subsequent to the issuance of the notes, affiliates of the noteholders entered into the Stock Purchase Agreement with the Company (See Notes 1 and 11).
Notes payable – related parties consisted of the following:
|
|
December 31, 2017 |
|
|
December 31, 2016 |
|
||
Notes Payable originating July 15, 2016; no monthly payments required; bearing interest at 10%; due on December 31, 2016, convertible on demand |
|
$ |
50,000 |
|
|
$ |
50,000 |
|
Notes Payable originating August 23, 2016; no monthly payments required; bearing interest at 10%; due on December 31, 2016, convertible on demand |
|
|
50,000 |
|
|
|
50,000 |
|
Notes Payable originating October 19, 2016; no monthly payments required; bearing interest at 10%; due on December 31, 2016, convertible on demand |
|
|
50,000 |
|
|
|
50,000 |
|
Total |
|
|
150,000 |
|
|
|
150,000 |
|
Less: current maturities |
|
|
(150,000 |
) |
|
|
(150,000 |
) |
Amount due after one year |
|
$ |
- |
|
|
$ |
- |
|
During the year ended December 31, 2017 and 2016, interest expense of $27,000 and $13,587 (of which $13,094 was related to the amortization of the beneficial conversion feature), respectively, was recognized on outstanding notes payable – related parties. As of December 31, 2017, and 2016, accrued interest payable was $32,096 and $5,096, respectively, which is included in accrued expenses on the accompanying consolidated balance sheets.
Note 7. Commitments and Contingencies
Legal Matters
On January 27, 2014, M. Richard Cutler and Cutler Law Group, P.C. (the “Plaintiffs”) filed a complaint in the District Court of Harris County, Texas, 201 4-03355, against Fuse, Alan Meeker, Rusty Shelton, Jonathan Brown, Robert H. Donehew and Golf Rounds.com, Inc. (the “Defendants”). On April 21, 2014, the complaint was dismissed for “want of prosecution.”
F-15
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
On September 18, 2015, Plaintiffs refiled a complaint in the District Court of Harris County, Texas, Cause No. 2015-55652 and added PH Squared, LLC as an additional Plaintiff. Thereafter, the term “Plaintiffs” collectively refers to M. Richard Cutler, Cutler Law Group, P.C. and PH Squared, LLC. The new complaint asserts essentially the same claims as the origina l nonsuited complaint: (i) suit on sworn account against Fuse; (ii) fraud against all Defendants; and (iii) breach of contract against all Defendants for allegedly violating a non-circumvention/non-disclosure agreement. Richard Cutler is the sole principal of Cutler Law Group, P.C., which provided legal representation to its clients, Craig Longhurst and PH Squared, LLC d/b/a PharmHouse Pharmacy (“Cutler’s Client”), during a failed merger attempt between Fuse and Golf Rounds.com, Inc. (the “Failed Transactio n”). The Plaintiffs have alleged that the Failed Transaction failed to materialize notwithstanding the efforts of Mr. Cutler, his law firm and PH Squared, LLC. The Plaintiffs have further alleged that the Defendants continued to pursue a similar transact ion without Cutler’s Client or the Plaintiffs. The Plaintiffs claim that the Defendants are responsible for damages in the amount of $46,465 plus interest for the breach of contract claim because Plaintiffs were not paid their legal fees by Cutler’s Clien t and Plaintiffs did not receive equity in the merged company that would have resulted from the Failed Transaction. Plaintiffs are also asking for undisclosed damages related to the fraud and breach of contract claims, and are asking for exemplary damages as a result of allegedly intentional fraud that some or all of the Defendants allegedly committed. Plaintiffs also seek their attorneys’ fees and costs for having brought the action. On November 18, 2015, Fuse filed a counterclaim against PH Squared, LLC f or breach of contract and further asserted a counterclaim and third-party claim against PH Squared, LLC’s principle, Craig Longhurst, for fraud in the inducement. Fuse also seeks a declaratory judgment on the intended third-party beneficiary status of Pla intiffs Cutler and Cutler Law Group related to a non-circumvention/non-disclosure agreement. The trial date for the above matter was scheduled for May 1, 2017, but it was moved to July 24, 2017 in order to allow for some additional discovery.
During April 2017, one of the named individuals in the complaint filed for bankruptcy protection. There is currently no trial date set.
The Company’s management continues to believe that the lawsuit is completely without merit and will vigorously contest it and protect the Company’s interests.
Operating Leases
The Company leases office space under a noncancelable operating lease agreement, from a real estate investments company that is owned and controlled by the Company’s Chairman of the Board and President. This lease terminated December 31, 2017 with month-to-month renewals. The lease requires monthly payments of $14,000. Annual rent expense was approximately $142,000 and $120,000 for the years ended December 31, 2017 and 2016, and are included in selling, general, administrative and other expenses.
The Company leases office equipment under two noncancelable operating lease agreements which expire March 2019 and February 2021. In aggregate, these office equipment leases require monthly payments of approximately $779. Rent expense for the equipment leases totaled approximately $11,000 and $8,000 for the years ended December 31, 2017 and 2016, respectively, and are included in selling, general, administrative and other expenses.
The following is a schedule by years of future minimum rental payments required under operating leases that have initial or remaining noncancelable lease terms in excess of one year as of December 31, 2017:
Note 8. Stockholders’ Equity
Authorized Capital
The Company has authorized 100,000,000 shares of common stock having a par value of $0.01 per share, and its Board is authorized to issue shares of the common stock, in one or more series, and to fix for each such series the voting powers, designations, preferences, or other special rights and the qualifications, limitations or restrictions.
F-16
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
The Company has authorized 20,000,000 shares of preferred stock having a par value of $0.01 per share, and its Board is authorized to issue shares of the preferred stock, in one or more series, and to fix for each such series the voting powers, designation s, preferences, or other special rights and the qualifications, limitations or restrictions.
Common Stock
On December 29, 2017, Fuse completed the previously-announced acquisition of CPM, pursuant to the CPM Acquisition Agreement by Fuse and NC 143, dated December 15, 2017, whereby the Fuse would purchase all of the outstanding membership interests of CPM. Fuse issued 50,000,000 shares of its common stock, par value $0.01 per share in exchange for 100% of the outstanding equity interests of CPM, at an agreed-upon value of $0.20 per share of common stock, as reflected in the fairness opinion provided by ValueScope. The Effective Date of the CPM acquisition was December 31, 2017.
On December 19, 2016, the Company entered into the Stock Purchase Agreement by and between the Investors and the Company, pursuant to which NC 143 acquired 5 million shares of the Company’s common stock for a purchase price of $400,000 and RMI acquired 4 million shares of the Company’s common stock for a purchase price of $320,000 , effective as of the Change-in-Control Date. Direct offering costs of the Company were $64,609 in connection with the offer and sale of the Investor Shares, and, net proceeds from the sale of the Investor Shares were $655,391. (See Note 6)
Stock Incentive Plans
The Company has a stock-based compensation plan which provides for the granting of equity awards, including qualified incentive and non-qualified stock options, stock appreciation awards and restricted stock awards to employees, directors, consultants and advisors; the 2017 Equity Incentive Plan (the “2017 Plan”), which was adopted by the Company’s Board on April 5, 2017. The awards are subject to a vesting schedule as set forth in individual agreements.
On September 21, 2017, the Board approved an amendment to the 2017 Plan to increase the number of shares of common stock authorized for issuance under the 2017 Plan from 1,500,000 shares of common stock to 2,500,000 shares of common stock.
On October 4, 2017, the Board approved an amendment to the 2017 Plan to increase the number of shares of common stock authorized for issuance under the 2017 Plan from 2,500,000 shares of common stock to 4,500,000 shares of common stock.
Stock Options
The Company estimates the fair value of share-based compensation utilizing the Black-Scholes option pricing model, which is dependent upon several variables such as the expected option term, expected volatility of the Company’s stock price over the expected option term, expected risk-free interest rate over the expected option term, expected dividend yield rate over the expected option term, and an estimate of expected forfeiture rates. The Company believes this valuation methodology is appropriate for estimating the fair value of stock options granted to employees and directors which are subject to ASC Topic 718 requirements. These amounts are the Company’s estimates and thus may not be reflective of actual future results, nor amounts ultimately realized by recipients of these grants. The Company recognizes compensation on a straight-line basis over the requisite service period for each award. The Company did not grant stock options in 2017.
The following table summarizes the assumptions the Company utilized to record compensation expense for stock options granted to employees during the year ended December 31, 2016:
Assumptions |
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Expected term (years) |
|
|
- |
|
|
|
2.5 |
|
Expected volatility |
|
|
0 |
% |
|
|
162 |
% |
Weighted-average volatility |
|
|
0 |
% |
|
|
162 |
% |
Risk-free interest rate |
|
|
0.00 |
% |
|
|
1.43 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected forfeiture rate |
|
n/a |
|
|
n/a |
|
F-17
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
The Company’s management utilized the simplified method to estimate the expected life for stock options granted to employees, as the Company does not have sufficient historical data regarding stock option exercises. The expected volatility is based on his torical volatility of the Company’s common stock subsequent to the closing of the Reverse Merger . The risk-free interest rate is based on the U.S. Treasury yields with terms equivalent to the expected life of the related option at the time of the grant. Dividend yield is based on historical trends. While the Company’s management believes these estimates are reasonable, the compensation expense recorded would increase if the expected life was increased, a higher expected volatility was used, or if the exp ected dividend yield increased.
A summary of the Company’s stock option activity during the year ended December 31, 2017 is presented below:
|
|
No. of Shares |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Remaining Contractual Term |
|
|
Aggregate Intrinsic Value |
|
||||
Balance outstanding at December 31, 2016 |
|
|
1,304,788 |
|
|
$ |
0.22 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
— |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(2,736 |
) |
|
$ |
12.13 |
|
|
|
|
|
|
|
|
|
Balance outstanding at December 31, 2017 |
|
|
1,302,052 |
|
|
$ |
0.20 |
|
|
|
3.3 |
|
|
$ |
1,717,000 |
|
Exercisable at December 31, 2017 |
|
|
1,302,052 |
|
|
$ |
0.20 |
|
|
|
3.3 |
|
|
$ |
1,717,000 |
|
The weighted-average grant-date fair value of options granted during the year ended December 31, 2016 was $0.09.
Restricted Common Stock
On September 21, 2017, the Company’s Board granted an aggregate of 325,000 Restricted Stock Awards (“RSA’s”) pursuant to the Company’s 2017 Plan, to the Board as annual compensation. The RSA’s have a fair market value of $0.78 on the date of grant and fully vest upon the one-year ann iversary of the date of grant or September 21, 2018. As of December 31, 2017, the Company had amortized $21,664 relating to the vesting of these shares which is included in selling, general, and administrative expenses, and $43,336 which will be recognized as an expense in future periods as the shares vest.
On September 21, 2017, the Company’s Board granted an aggregate of 2,000,000 RSA’s pursuant to the 2017 Plan, to the Company’s independent directors as compensation. The RSA’s have a fair market value of $0.78 on the date of grant and vest fully upon the earlier of a change in control of the Company or the Company’s listing on a national securities exchange. As of December 31, 2017, the Company had not amortized any amounts relating to the vesting of these shares due to the uncertainty of meeting these vesting milestones.
On December 14, 2017, the Board awarded a total of 942,500 shares of common stock of the Company, in the form of RSAs issued in accordance with the 2017 Plan of the Company, to the members of the Board of the Company as annual compensation for services rendered to the Company as Board members. Each member of the Board was granted an RSA constituting 188,500 shares of the Company’s common stock. Based in part on the analysis of the fairness opinion provided by a third-party valuation specialist, the Board determined that the common stock within each RSA had a fair market value of $0.20 on the date of grant. As of December 31, 2017, the Company had amortized $20,945 relating to the vesting of these shares which is included in selling, general, administrative and other expenses, and $167,555 which will be recognized as an expense in future periods as the shares vest.
The Board voted to revise the $0.78 fair market value for each share issued pursuant to each RSA granted on September 21, 2017, to $0.20. The Board voted to amend the indicated fair market value in the September grants to $0.20 based in part on the analysis within the fairness opinion provided by the third-party valuation specialist.
The following table summarizes restricted common stock activity:
F-18
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Note 9. Income Taxes
As a result of the CPM Acquisition, Fuse became the sole managing member of CPM and as a result, began consolidating the financial results of CPM. CPM is treated as a partnership for U.S. federal and most applicable state and local income tax purposes. As a partnership, CPM is not subject to U.S. federal and most applicable state and local income tax purposes. As a partnership, CPM is not subject to U.S. federal and certain state and local income taxes. Any taxable income or loss generated by CPM is passed through to an included in the taxable income or loss of its members.
Fuse is subject to U.S. federal income taxes, in addition to state and local income taxes.
The components of income tax expense (benefit) are as follows:
|
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Current: |
|
|
|
|
|
|
|
|
Federal |
|
$ |
- |
|
|
$ |
- |
|
State |
|
|
40,818 |
|
|
|
51,627 |
|
|
|
|
40,818 |
|
|
|
51,627 |
|
Deferred: |
|
|
|
|
|
|
|
|
Federal |
|
|
- |
|
|
|
- |
|
State |
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
Total Income tax expense (benefit) |
|
$ |
40,818 |
|
|
$ |
51,627 |
|
F-19
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Significant components of the Company's deferred income tax assets and liabilities are as follows:
|
|
December 31, 2017 |
|
|
December 31, 2016 |
|
||
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryover |
|
$ |
172,704 |
|
|
$ |
224,381 |
|
Intangibles |
|
|
40,342 |
|
|
|
- |
|
Accounts receivable |
|
|
81,927 |
|
|
|
- |
|
Compensation |
|
|
57,458 |
|
|
|
80,850 |
|
Inventory |
|
|
25,792 |
|
|
|
- |
|
Total deferred tax assets |
|
|
378,223 |
|
|
|
305,231 |
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses |
|
|
- |
|
|
|
- |
|
Property and equipment |
|
|
(2,945 |
) |
|
|
2,795 |
|
Total deferred tax liabilities |
|
|
(2,945 |
) |
|
|
2,795 |
|
Deferred tax assets, net |
|
|
375,278 |
|
|
|
308,026 |
|
Valuation allowance: |
|
|
|
|
|
|
|
|
Beginning of year |
|
|
(308,026 |
) |
|
|
(700,713 |
) |
(Increase) decrease during year |
|
|
308,026 |
|
|
|
392,687 |
|
Ending balance |
|
|
- |
|
|
|
(308,026 |
) |
Net deferred tax asset |
|
$ |
375,278 |
|
|
$ |
- |
|
In 2016 and 2017 CPM is treated as a partnership for U.S. federal and most applicable state and local income tax purposes. As a partnership, CPM is not subject to U.S. federal and certain state income taxes. Any taxable income or loss generated by CPM during 2016 and 2017 is passed through to and included in the taxable income or loss of its members. Accordingly, our consolidated financial statements for 2017 do not include a provision for federal or state income tax purposes.
Fuse is treated as a corporation for U.S. federal and applicable state and local income tax purposes. As a corporation, Fuse is subject to U.S. federal and applicable state income taxes.
A valuation allowance is established if it is more likely than not that all or a portion of the deferred tax asset will not be realized. The Company has recorded a valuation allowance in 2016 due to the uncertainty of realization. As a result of the organizational transactions of Fuse and CPM in 2017, it is more likely than not that the tax deferred tax assets benefits would be realized.
At December 31, 2017, Fuse had $ 822,399 of net operating loss carryforwards which will expire from 2018 to 2037. These carry forward benefits may be subject to annual limitations due to the ownership change limitations imposed by the Internal Revenue Code and similar state provisions. The annual limitation, if imposed, may result in the expiration of net operating losses before utilization. The Company believes its tax positions are all highly certain of being upheld upon examination. As such, the Company has not recorded a liability for unrecognized tax benefits. As of December 31, 2017, tax years 2012 through 2015 remain open for IRS audit. The Company has received no notice of audit from the Internal Revenue Service for any of the open tax years.
A reconciliation of income tax computed at the U.S. statutory rate to the effective income tax rate is as follows:
|
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Statutory U.S. federal income tax rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
State income taxes, net of federal tax benefit |
|
|
5.8 |
% |
|
|
1.7 |
% |
Permanent differences |
|
|
3.8 |
% |
|
|
0.3 |
% |
Other reconciling items |
|
|
20.5 |
% |
|
|
19.8 |
% |
LLC flow-through structure |
|
|
(59.3 |
%) |
|
|
(42.1 |
%) |
Valuation allowance |
|
|
0.0 |
% |
|
|
(13.0 |
%) |
Effective income tax rate |
|
|
5.8 |
% |
|
|
1.7 |
% |
F-20
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Note 10. Concentrations
Concentration of Revenues, Accounts Receivable and Suppliers
For the years ended December 31, 2017 and 2016, the following significant customers had an individual percentage of total revenues equaling 10% or greater:
|
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Customer 1 (related party) |
|
|
18.70 |
% |
|
|
18.33 |
% |
Customer 2 |
|
|
18.06 |
% |
|
|
11.61 |
% |
Totals |
|
|
36.76 |
% |
|
|
29.94 |
% |
At December 31, 2017 and 2016, the following significant customers had a concentration of accounts receivable representing 10% or greater of accounts receivable:
|
|
December 31, 2017 |
|
|
December 31, 2016 |
|
||
Customer 1 (related party) |
|
|
24.80 |
% |
|
|
25.21 |
% |
Customer 2 |
|
|
15.26 |
% |
|
|
12.92 |
% |
Totals |
|
|
40.06 |
% |
|
|
38.13 |
% |
For the years ended December 31, 2017 and 2016, the following significant suppliers represented 10% or greater of goods purchased:
|
|
For the Year Ended December 31, 2017 |
|
|
For the Year Ended December 31, 2016 |
|
||
Supplier 1 |
|
|
22.34 |
% |
|
|
22.36 |
% |
Totals |
|
|
22.34 |
% |
|
|
22.36 |
% |
Note 11. Related Party Transactions
Change in Control
Between the period July 2016 through October 2016, we obtained three loans in the aggregate amount of $150,000 in exchange for convertible promissory notes (the “Notes”) bearing 10% interest per annum, with principal due and payable, upon demand of the payee. The Notes were issued as follows: $100,000 to NC 143 Family Holdings, LP, a family limited partnership controlled by Mark W. Brooks (“NC 143”), our Chairman of the Board of Directors (the “Board”); and $50,000 to Reeg Medical Industries, Inc., an investment holding company owned and controlled by Christopher C. Reeg, our Chief Executive Officer (“RMI”, and together with NC 143, the “Investors”). The Investors have the sole discretion and right to convert all or any portion of the then unpaid principal and interest balance of the Notes into shares of our common stock at a conversion price of $0.08 per share.
Since December of 2016, the Company has been controlled by the Investors, who are its two primary stockholders. On the Change- in-Control Date the Company entered into the Stock Purchase Agreement by and between the Investors and the Company, pursuant to which the Investors received the Investor Shares, effective as of the Change-in-Control Date. For more details please see “Item 1. Business” of this 2017 Annual Report
The closing of the Stock Purchase Agreement resulted in a change-in-control of the Company whereby the Investors beneficially acquired approximately 61.4% of the Company’s Common Stock issued and outstanding immediately after the Change-in-Control Date. Mark W. Brooks became the Chairman of the Board and Christopher C. Reeg became our Chief Executive officer, as described in our Current Report on Form 8-K, filed with the SEC on December 23, 2016, which is herein incorporated by reference.
F-21
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
On December 15, 2017, Fuse entered into an agreement with NC 143 pursuant to which Fuse would purchase all of the outstanding membership interests of CPM Medical Consultants, LLC (“CPM”) (the “CPM Acquisition Agreement” and such transaction, the “CPM Acquisition”).
On December 29, 2017, Fuse completed the previously-announced acquisition of CPM Acquisition, pursuant to the CPM Acquisition Agreement by Fuse and NC 143, dated December 15, 2017, whereby Fuse would purchase all of the outstanding membership interests of CPM. Fuse issued 50 million shares of its common stock, par value $0.01 per share in exchange for 100% of the outstanding membership interests of CPM, at an agreed-upon value of $0.20 per share of common stock. The effective date of the CPM Acquisition was December 31, 2017 (the “Effective Date”). The CPM Acquisition provides for contingent payments to NC 143 subject to certain sales and profitability targets being met by the Company for years after 2017.
For accounting purposes, CPM was deemed to have acquired Fuse in the CPM Acquisition because NC 143 and RMI had combined majority control of our issued and outstanding common stock and they jointly have the power to appoint a majority of our members of the Board. Because Fuse is the legal acquirer, the CPM Acquisition was accounted for as a reverse acquisition of an entity under common control. CPM is the successor entity and becomes the reporting entity which combines Fuse at the Change-in-Control Date, with the assets and liabilities of both companies combined at historical cost (collectively, Fuse and CPM consolidated or the “Company”). (see note 3)
Lease with 1565 North Central Expressway, LP
The Company leases an approximately 11,500 square-foot space as its principal executive office, located at 1565 North Central Expressway, Suite 220, Richardson, Texas 75080 from 1565 North Central Expressway, LP, a real estate investment company that is owned and controlled by the Company’s Chairman of the Board and President. The CPM lease was effective January 1, 2013 and the Fuse lease was effective July 14, 2017. The leases terminated December 31, 2017 with month-to-month renewals. The leased property does not have material costs of complying with environmental laws. The Company believes its present business property is adequate and suitable to support its mid-term strategies and initiatives for growth. They are in the process of renegotiating a lease renewal, but there is a large supply of comparable commercial property available in the general area that we would be able to lease at comparable lease rates.
AmBio Contract
The Company has engaged AmBio Staffing, LLC (“AmBio”) a Texas licensed Professional Employment Organization, (“PEO”) to provide payroll processing, employee benefit administration, and related human capital services effective January 1, 2017. The Company’s Chairman of the Board and President, Mark W. Brooks, owns and controls AmBio. As of March 26, 2018, AmBio operations supports approximately 74 full time equivalents (“FTE”). Of those 74 FTEs, 42 FTEs directly support the Company, 19 FTEs support the operations of other companies and the Company shares 13 FTEs with other companies.
Operations
The Company enters into various related party transactions with entities that are owned by or affiliated with the Company’s Named Executive Officers and Directors. The transactions included sales, purchases, commissions paid for services, and revenues related to services provided to the related party.
MedUSA Group, LLC
MedUSA Group, LLC (“MedUSA”) is a sub-distributor owned and controlled by our Chairman of the Board and Chief Executive Officer.
During the years ended December 31, 2017 and 2016, we had net sales of approximately $5,054,000 and $4,797,000, respectively, to MedUSA for product used in surgical cases.
During the years ended December 31, 2017 and 2016, we incurred commission expense of approximately $962,000 and $642,000, respectively, to MedUSA for services provided to us in surgical cases.
As of December 31, 2017, and 2016, we had balances due from MedUSA of approximately $1,684,000 and $1,752,000, respectively, included in accounts receivable on the accompanying consolidated balance sheets.
F-22
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
Texas Overlord, LLC (“Overlord”) is an investment holding company owned and controlled by our Chairman of the Board.
During the years ended December 31, 2017 and 2016, we had net sales of approximately $1,953,000 and $0.00, respectively, to Overlord for product used in surgical cases.
During the years ended December 31, 2017 and 2016, we incurred commission expense of approximately $101,000 and $0.00, respectively, to Overlord for services provided to us in surgical cases.
As of December 31, 2017, and 2016, we had balances due from Overlord of approximately $444,000 and $0.00, respectively, included in accounts receivable on the accompanying consolidated balance sheets.
N.B.M.J., Inc.
N.B.M.J., Inc. (“NBMJ”) is a Durable Medical Equipment (“DME”) distributor and a wound care distributor owned and controlled by our Chairman of the Board.
During the years ended December 31, 2017 and 2016, we had net sales of approximately $162,000 and $715,000, respectively, to NBMJ for product used in surgical cases.
During the years ended December 31, 2017 and 2016, we incurred commission expense of approximately $0.00 and $0.00, respectively, to NBMJ for services provided to us in surgical cases.
As of December 31, 2017, and 2016, we had balances due from NBMJ of approximately $0.00 and $47,000, respectively, included in accounts receivable on the accompanying consolidated balance sheets.
Palm Springs Partners d/b/a Maxim Surgical, LLC
Palm Springs Partners d/b/a Maxim Surgical, LLC (“Maxim”) is a manufacturer/distributor owned and controlled by Christopher C. Reeg, our Chief Executive Officer and Secretary, and Mark W. Brooks, our Chairman of the Board and President.
During the year ending December 31, 2017 and 2016, we had net sales of approximately $202,000 and $164,000 to Maxim for product used in surgical cases.
During the year ending December 31, 2017 and 2016, we purchased approximately $468,000 and $458,000 from Maxim.
As of December 31, 2017, and 2016, we had a balance due from Maxim of approximately $50,000 and $45,000, included in accounts receivable on the accompanying consolidated balance sheets.
As of December 31, 2017, and 2016, we had a balance due to Maxim of approximately $93,000 and $102,000, included in accounts payable on the accompanying consolidated balance sheets.
Sintu, LLC
Sintu, LLC (“Sintu”) is a sub-distributor owned and controlled by Mark W. Brooks, our Chairman of the Board and President.
During the year ended December 31, 2017 and 2016, we incurred commission expense of approximately $1,114,000 and $692,000 to Sintu for services provided in surgical cases.
Other
During the years ended December 31, 2017 and 2016, the Company had net sales of approximately $1,055,000 and $396,000, respectively, to these entities for product used in surgical cases.
During the years ended December 31, 2017 and 2016, the Company had purchases of approximately $128,000 and $8,000, respectively, from these entities.
During the years ended December 31, 2017 and 2016, the Company incurred commission expense of approximately $248,000 and $702,000, respectively, to these entities for services provided in surgical cases.
F-23
FUSE MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2017 AND 2016
The Company also had other income related to charges for shared services it provided to the related party of approximately $33,000 and $114,000 for the years ended December 31, 2017 and 2016, respectively, included with selling, general, and administrative expenses on the accompanying co nsolidated statements of operations.
As of December 31, 2017, and 2016, the Company had balances due from these entities of approximately $169,000 and $159,000, respectively, included in accounts receivable on the accompanying consolidated balance sheets.
The Company engages AmBio, a licensed PEO to provide payroll processing, employee benefit administration, and related human capital services. AmBio is controlled by the Chairman of the Board and President. As of December 31, 2017, and 2016, the Company had balances due to AmBio of approximately $112,000 and $107,000. As of December 31, 2017, and 2016, approximately $162,000 and $162,000 of fees were paid to AmBio for such services, respectively, and are reflected with in selling, general, and administrative expenses on the accompanying consolidated statements of operations.
Note 12. Subsequent Events
In preparing these financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through April 5, 2018, the date the financial statements were available to be issued.
On January 30, 2018, the Company received notice from UOC USA, Inc. (“UOC”) that UOC has elected to terminate the distribution agreement dated January 1, 2011, as amended (the “UOC Agreement”) between the Company’s wholly-owned subsidiary, CPM, and UOC. While the UOC Agreement terminated on February 28, 2018, in accordance with its terms and conditions, the UOC Agreement also authorized the continued provision of UOC products at UOC-contracted facilities until March 15, 2018. Because we hold title to our UOC inventory, we may continue selling UOC products until we deplete our UOC inventory.
Pursuant to the UOC Agreement, in consideration for mutual promises and covenants, the Company was appointed as a non-exclusive authorized distributor of UOC orthopedic implants and instruments for an initial fixed term of two years with auto-renewals thereafter. Either the Company or UOC could terminate the UOC Agreement at any time and for any reason upon ninety (90) days prior written notice to the other party.
At UOC’s sole discretion, the termination notice provides for the repurchase of the Company’s unsold UOC orthopedic implants by UOC on or before April 30, 2018. The Company’s revenue derived from the sale and distribution of UOC products was approximately $4.3 million or 16% and $4.9 million or 19%, for the year-ended December 31, 2017, and December 31, 2016, respectively.
The Company’s Management concluded there are no other material events or transactions for potential recognition or disclosure.
F-24
N U M B E R
S H A R E S
COMMON STOCK
PAR VALUE $.01
COMMON STOCK
PAR VALUE $.01
CUSIP 36113U 10 1
FUSE MEDICAL, INC.
(INCORPORATED UNDER THE LAWS OF DELAWARE)
SEE REVERSE FOR CERTAIN DEFINITIONS
This certifies that
is the owner of
FULLY PAID AND NON-ASSESSABLE SHARES OF THE PAR VALUE $.01 EACH, OF THE COMMON STOCK OF
FUSE MEDICAL, INC.
transferable on the books of the Corporation by the holder hereof, in person or by duly authorized attorney, upon surrender of this Certificate properly endorsed. This Certificate is not valid unless countersigned by the Transfer Agent and registered by the Registrar.
WITNESS the facsimile seal of the Corporation and the facsimile signatures of its duly authorized officers.
Dated:
•
SEAL
CHIEF EXECUTIVE OFFICER
CHIEF FINANCIAL OFFICER
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Countersigned and Registered
AMERICAN STOCK TRANSFER AND TRUST COMPANY, LLC
Transfer Agent and Registrar
By
AUTHORIZED SIGNATURE
•
•
•
•
•
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Th e fo ll o w i ng abbr ev iation s , wh e n u se d in th e in s cription on th e fac e of thi s c e rtificat e , s hall b e con s tru e d a s though th ey w e r e w r i tt e n out i n f ull according t o app l icable l aw s or re g u l ation s :
TE N COM T EN EN T JT T E N
UNIF GIFT MIN ACT - .
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UNIF TRF M I N ACT - ..
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Additional abbr ev iation s may al so b e u se d thou g h not in th e abo ve l i s t .
For Va l ue received , h ere b y se ll , assig n an d transfer unto
PLE AS E I NS ERT SOC I A L S E C URIT Y O R O THER IDE N TIF Y IN G NU MB ER O F ASS I G NEE
PL EA S E PRI N T OR TYP E WRIT E NAME AN D A DDR E SS . I N CLUDI N G P O STAL Z I P COD E, O F A SSIG NEE
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to tran s fer the s a i d stock on th e book s of th e w it hi n nam e d Corpora ti on with f u ll powe r of s u b s tit u t i on i n th e pr e m i s e s .
Date d
x _ x _
NOT I C E : - i H S H N t : E T ; H : R
N i
T i ;_ R
C ER TI F I C ATE I N E V ERY P A RT I C ULAR W I T HOU T ALTER A T I ON OR EN L ARGE M ENT OR A N Y CHANGE W HATE V ER .
Signature(s) Guaranteed :
By _ THE SIGNATURE(S) MUST BE GUARANTEED BY AN ELIGIBLE GUARANTOR INST I TUT I ON (BANKS, STOCKBROKERS , SAVINGS AND LOAN ASSOCIATIONS AND CREDIT UNIONS WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM) , PURSUANT TO S . E . C . RULE 17Ad - 15 .
KEEP THIS CERTIFICATE IN A SAFE PLACE . IF IT IS LOST , STOLEN , MUTILATED OR DESTROYED , THE CORPORATION WILL REQUIRE A BOND OF INDEMNITY AS A CONDITION TO THE ISSUANCE OF A REPLACEMENT CERTIFICATE .
Exhibit 10.4
CPM MEDICAL CONSULTANTS, LLC
STOCKING AND SUBDISTRIBUTION AGREEMENT
THIS STOCKING AND SUBDISTRIBUTION AGREEMENT, dated as of [_______________, 20____] (the “ Agreement ”), is entered into by and between CPM Medical Consultants, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and [___________________________], a [______________] corporation having its principal place of business at _____________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor is in the business of distributing medical products and wishes to distribute the Products within the Territory; and
WHEREAS, Distributor wishes to engage Subdistributor to provide supplemental Product distribution on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Appointment
Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive subdistributor to Distributor of the Products in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
Excluded Customers . Notwithstanding 0 , Distributor does not appoint Subdistributor as its subdistributor of the Products for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in Product subdistribution activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer.
Status as Independent Contractor .
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party.
- 1 -
Rev 11172017
137478606.3
The operations of Subdistributor are subject to the sole control of Subdistributor. Subdistributor is solely responsible for its Personnel and there are no joint employment relationships with Distributor regarding such Personnel by virtue of this Agreement. Without limitation of the foregoing, Subdistributor is solely responsible for, at its own expense: (i) providing such office space and facilities, and such Personnel (and their training) as may be necessary to carry out its obligations under this Agreement; (ii) compensating all Subdistributor Personnel for any services rendered in connection with the performance of its obligations under this Agreement; (iii) covering all Personnel under any applicable social benefit laws (including workers’ compensation and applicable state disability insurance) and obtaining any other customary insurance pertaining to Subdistributor’s operations and Personnel; and (iv) making any and all payroll deductions and contributions that may be required by Law or otherwise with respect to the Personnel. Subdistributor shall be solely responsible for any and all costs or expenses that it may incur in the performance of its obligations under this Agreement.
Reserved.
Subdistributor Obligations
Subdistribution .
Subdistributor shall perform the following during the Term:
Subdistributor . Subdistributor shall market, promote, and solicit orders for the Products as a subdistributor to Distributor to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in a manner consistent with Distributor’s Product marketing strategies and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor and its Suppliers;
Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a subdistributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal business hours with general support; and train Customers, including surgeons and hospital staff members, on the proper use of the Products;
Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory;
Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
- 2 -
Rev 111717
137478606.3
Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor or otherwise made available by Distributor’s Suppliers in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the respective policies of Distributor and its Suppliers applicable to Product distribution;;
Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
Recall Assistance . Subdistributor shall assist the Distributor and its Suppliers in effectuating any recall of the Products;
Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review matters pertaining to this Agreement as applicable;
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Product Delivery and Operating Room Support . Subdistributor shall be solely responsible for (i) scheduling the delivery of Products that it is distributing to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and (ii) providing case coverage and arranging for qualified and credentialed Subdistributor Personnel to be available and present in the operating room suite to provide the Products and applicable instrumentation associated with the Products and related Product technical support;
Litigation Support . Subdistributor shall render reasonable assistance to the Distributor and its Suppliers in the defense of any and all product liability claims;
Product Specialists . Subdistributor shall employ at least one Product specialist with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier;
Records and Audit . Subdistributor shall maintain records of its purchasing activities (including copies of the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker) and shall provide a copy of such records or otherwise make such records available to Distributor at Distributor’s request and election. Subdistributor shall also submit to Distributor, on a quarterly basis, a report containing detailed information, by Product, on Subdistributor’s customers, sales, and subdistribution activities in the preceding quarter, as well as a forecast of its approximate requirements for the Products for the subsequent four quarters. Distributor shall have the right to audit and inspect Subdistributor’s Product inventory and the records maintained by Subdistributor at any time and from time to time upon reasonable advance notice. Subdistributor agrees to fully cooperate with and assist Distributor in such inspections and audits; and
Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
Credentialing and Training .
To ensure Subdistributor is meeting the highest standards required by Distributor and its Suppliers, Subdistributor shall, during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the Supplier may provide from time to time relative to the Products. In addition, the Subdistributor shall be solely responsible for ensuring that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
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make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
generate any invoices on behalf of the Distributor for Products sold;
engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
Distributor Obligations
Distributor Obligations . During the Term, Distributor shall:
Shipment of Products and Instruments . Subject to Product availability and the terms and conditions of this Agreement, Distributor shall use reasonable efforts to fill Subdistributor’s orders for Products and Instruments, which are accepted by Distributor. It is understood by the Parties that expected delivery times will vary according to manufacturing and other conditions and that all delivery dates are estimates.
Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives and/or authorized subdistributors of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
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Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement to the extent such information and material is made available to Distributor by its Suppliers;
Samples . Distributor shall provide to Subdistributor samples and prototypes that are not intended for resale to the extent such are made available by its Suppliers and at the same cost (if any) assessed by its Suppliers. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in 0 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term; and
Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time.
Orders for Products and Instruments
Purchase Orders .
Subdistributor shall submit to Distributor written purchase orders for the Products and Instruments it elects to purchase and distribute pursuant to this Agreement, which orders shall include: (i) a list of the Products and Instruments ordered, (ii) the quantities of such Products and Instruments, and (iii) precise instructions for packaging, invoicing and shipping.
Consigned Inventory. Subdistributor may elect to order Product and Instrument stocking inventory on a consigned basis. Such orders for consigned inventory shall be subject to acceptance by Distributor and shall remain the property of Distributor until such time as the consigned inventory has been purchased.
Shipment Terms .
Subject to receipt and acceptance by Distributor of an order for purchase or consignment, unless otherwise agreed in writing, shipments, whether for purchased or consigned Product, shall be F.O.B. Distributor’s facility in Richardson, TX. Distributor shall not be obligated to make direct shipments to Subdistributor’s customers, unless otherwise agreed by the Parties. Distributor’s obligation to effect shipment of the Products and Instruments shall be fully discharged and all title (for purchased items) and risk of loss or damage (for all items) shall pass to Subdistributor when the Products and the Instruments are delivered to a carrier for shipment to Subdistributor. In addition, Subdistributor shall pay all charges, including, without limitation, all transportation charges and insurance premiums associated with the shipment and purchasing of the Products.
Modification or Cancellation of Orders .
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No accepted order shall be cancelled or modified except upon the written agreement of both Parties. Subdistributor’s orders or mutually agreed change orders shall be subject to all of the terms and conditions of this Agreement, whether or not the order or change order so states. In the event Subdistributor cancels an order after such order has been accepted by Distributor, Subdistributor shall reimburse Distributor for all costs incurred as a result of such order.
Product and Policy Changes .
Distributor reserves the right from time to time and in its discretion, without incurring any liability to Subdistributor: (i) to discontinue or limit its distribution of any Product; (ii) to allocate or to terminate or limit deliveries of any Product; (iii) to alter the design or construction of any Product or Instrument; (iv) to add new and additional Products; and (v) upon reasonable notice to Subdistributor, change its sales and purchasing policies to the extent that such changes are not inconsistent with the terms of this Agreement.
No Shipment Obligation .
Distributor shall not be obligated to make any shipment if such shipment could, at the time thereof, constitute a violation of any laws, regulations or policies.
Acceptance of Products and Instruments .
Subdistributor shall conduct any incoming inspections or acceptance tests as soon as possible upon arrival of the Products or Instruments at the shipping address, but in no event later than ten (10) days from the date of receipt. Any Products or Instruments not rejected by Subdistributor by written notice to Distributor within such period shall be deemed accepted. Subdistributor shall promptly report to Distributor any shortage, damage, or discrepancy in or to a shipment of Products or Instruments discovered by Subdistributor during such ten (10) day acceptance period and furnish written evidence or other documentation that Distributor deems appropriate. If the substantiating evidence delivered by Subdistributor demonstrates to Distributor’s satisfaction that such shortage, damage or discrepancy existed at the time of delivery of the Products or Instruments to the carrier, Distributor shall, at its discretion, promptly deliver additional or substitute Products or Instruments to Subdistributor at Distributor’s expense or issue a credit to Subdistributor.
Product Return .
Except as provided in this Section, Subdistributor may not return any Product to Distributor for any reason without Distributor’s prior written consent. Further, the following shall apply: (a) Sterile merchandise, which has been opened, has a breach of the package integrity, or has otherwise been damaged, will not be credited upon return; (b) special order or custom items will not be credited upon return; (c) obsolete merchandise not listed in Distributor’s then-current Product catalogs cannot be returned; and (d) items with an expired shelf life or sterile expiration date cannot be returned.
Price and Payment
Price. Subdistributor shall pay for the Products and the Instruments purchased under this Agreement at the prices set forth on Distributor’s then current price list. All prices include packing in accordance with Distributor’s standard practices in effect at the time of shipment. Special packing or handling shall be at
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the sole expense of Subdistributor.
Price Changes. Pricing for all Products shall remain in effect during the term of this Agreement unless mutually agreed upon in writing by both Distributor and Subdistributor. In the event that Distributor reduces the price of the Products or the Instruments ordered by Subdistributor, Distributor may, in its sole discretion and upon Subdistributor’s written request within thirty (30) days of each shipment, issue a credit to Subdistributor in the amount of the price reduction applicable to that shipment.
Payment. Subdistributor shall pay for the Products and the Instruments within thirty (30) days of receipt of invoice for said Products or Instruments.
Taxes . Subdistributor is responsible for and shall pay or reimburse Distributor for all taxes (except Distributor’s net income taxes), duties, assessments and other governmental charges, however designated, associated with the purchase and purchasing of Products and the performance of this Agreement.
Subdistributor Warranties . Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; (f) when executed and delivered by each of Distributor and Subdistributor, this Agreement will constitute the legal, valid, and binding obligation of Subdistributor, enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity); (g) Subdistributor shall conduct its activities and perform its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such laws, rules or regulations, and bear all of its costs and expenses in connection therewith; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time.
No Inconsistent Warranties . Subdistributor shall not make any claims or representations concerning the Products that are inconsistent with those made by Distributor or its Suppliers.
Supplier Warranties . The warranties made by Supplier with respect to each Product are solely those that are contained in the product insert accompanying such Product. No other affirmation of fact or promise made by Distributor or its Suppliers, whether or not in this Agreement, by words
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or action shall constitute a warranty. The foregoing warranty does not extend to any Product that is modified or altered, or treated with abuse, negligence or other improper treatment.
Standard Limited Warranty. Distributor shall pass on to Subdistributor so that it may pass on to the customers the Supplier's standard limited warranty for Products, including limitations set for in subsection (b) Limitation of Liability and Warranty below. Except for the stated warranty set forth on, or included with, the Products as delivered to the Subdistributor and /or its customers, the warranty and remedy set forth in this 0 are exclusive and all other warranties, guarantees or representations, express or implied, by Distributor’s Suppliers with respect to the applicable Products, including, without limitation, warranties of merchantability and fitness for particular purpose, and any other obligation or liability of Distributor and its Suppliers to Subdistributor or to any third party with respect to the Products, are hereby excluded. This warranty is contingent upon proper use of a Product in the application for which such Product was intended and does not cover Products that were modified without Distributor or its Supplier’s prior written approval, that have expired or that were subjected to physical, chemical or electrical stress that the products were not originally designed for.
Limitation of Liability and Warranty. Distributor and its Suppliers’ liability arising out of this agreement and/or sale of the products shall be limited as follows: in no event shall Distributor and its Suppliers be liable for costs of the procurement of substitute goods by anyone. In no event shall Distributor and its Suppliers be liable to Subdistributor or any other entity for any special, consequential, incidental, or indirect damages, however caused, on any theory of liability or breach of warranty, whether or not Distributor and its Suppliers have been advised on the possibility. Except for the express limited warranty set forth in previous subsection (a) Standard Limited Warranty above, Distributor and its Suppliers grant no implied warranties for the Products, either in fact or by operation of law, by statute, or otherwise.
Warranty Disclaimer . EXCEPT AS EXPRESSLY PROVIDED HEREIN, DISTRIBUTOR AND ITS SUPPLIERS MAKE NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD, CONSIGNED OR LOANED OR OTHERWISE DISTRIBUTED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
IP Rights
Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).
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Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor and in accordance with the Supplier guidelines relative to such Product marketing. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to 0 or 0 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
Distributor’s Right to Terminate . Distributor may terminate this Agreement by providing written notice to Subdistributor:
at any time for its convenience upon thirty (30) days prior written notice;
if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee,
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receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; or (b) if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
Effect of Expiration or Termination .
Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to 0 and (ii) were incurred by the Parties prior to such expiration or earlier termination.
Upon the expiration or earlier termination of this Agreement, and subject to Distributor elections set forth in subsection (c) below, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized subdistributor with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) make arrangements with Distributor relative to the handling and return of any consigned Products or Instruments; (iii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iv) to the extent legally permissible to do so, permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (v) certify in writing to Distributor that it has complied with the requirements of this 0. In the event (i) Subdistributor does not immediately return all such consigned Products and Instruments, or (ii) Distributor, in its discretion, determines that the consigned Products and Instruments that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Products and Instrument price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any consigned Products or Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon return and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subject to all of the terms and conditions of this Agreement, upon any termination or expiration of this Agreement for any reason whatsoever, Subdistributor shall retain the non-exclusive right to distribute the remaining Products that it purchased and remain in its inventory on the date of termination for 12 months (and all of the terms and conditions of this Agreement shall continue to apply during such 12 month period), unless Distributor exercises the option in the following sentence. Distributor shall have the option at any time after expiration or termination of this Agreement to immediately terminate Subdistributor’s rights to distribute its purchased inventory by repurchasing Subdistributor’s purchased inventory of Products at the
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price Subdistributor paid for that inventory and payment of Distributor’s then-current restocking fees applicable to such Products. Notwithstanding the foregoing, in no event shall Distributor have any obligation to repurchase Subdistributor’s purchased inventory.
Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
is or becomes generally available to the public other than as a result of any direct or indirect breach of this 0 by Subdistributor or any of its Representatives;
is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
is required to be disclosed pursuant to applicable Law.
Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this 0 caused by any of its Representatives.
Regulatory Matters
Medical Device Reporting Requirements . Subdistributor shall provide such assistance and information as Distributor and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor shall: (1) immediately
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transmit to Distributor all oral or written complaints regarding the Products that are received by Subdistributor; (2) keep and maintain a record of all customer complaints received by Subdistributor relating to the Products that are required to be maintained by Subdistributor pursuant to 21 C.F.R. § 803.18; (3) notify Distributor upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor and its Suppliers. It is the sole responsibility of Distributor and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territory. Notwithstanding the foregoing, in the event that Subdistributor is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor from doing so; provided, however, that Subdistributor shall immediately provide Distributor with prior notice of such reporting (to the extent legally permissible) and provide Distributor with copies of any such filings or reports (to the extent legally permissible).
Compliance with U.S. Food and Drug Administration Recall Policy . In order to assure compliance with FDA Recall policies, the Subdistributor will provide Distributor with a record of each surgery in which Distributor’s Suppliers’ respective Products sold to Subdistributor have been implanted. Distributor and Subdistributor will fully comply with all requirements of HIPAA including safeguarding the names and medical records of patients. The information required to be reported to Distributor by Subdistributor will be the Hospital Proof of Delivery form or a Charge Sheet from the Subdistributor which must include the date of surgery, the name of the hospital in which the surgery was performed, the name of the surgeon performing the surgery and a list of products implanted by unit catalog number, lot number and sterility expiration date. The first name and first initial of the patient’s last name will also be included, but the full name of the patient will be retained by Subdistributor and immediately reported to Distributor in the event of an actual recall of the implanted products. Failure of the Subdistributor to provide this information may cause Distributor to delay shipment of replacement / restock products to Subdistributor until such information has been provided.
Governmental Inspections and Inquiries . Subdistributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor in writing of, and shall provide Distributor with copies of, any correspondence and other documentation received or prepared by the Subdistributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority:
Receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the storage, marketing, advertisement, sale and/or purchasing of the Product(s); and
Any Governmental or Regulatory Authority’s comments relating to the Product(s) that may require a response or action by Distributor.
Without limiting the generality of the foregoing, in the event that the Subdistributor or any of its Representatives receive a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Product(s) that requires a response or action by Distributor and/or its Suppliers, the Subdistributor shall promptly provide to Distributor any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing of the Product(s), and the Subdistributor will cooperate fully with Distributor in preparing such response.
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In the event any facility that is used by the Subdistributor or any of its Representatives to store, market advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor shall notify the Distributor promptly upon learning of such inspection and shall supply Distributor with copies of any correspondence that relates to such inspection. Distributor may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Product(s). The Subdistributor shall (to the extent legally permissible) furnish to Distributor copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with five (5) business days after the delivery of such information by the Governmental or Regulatory Authority.
The Distributor shall, at its discretion and to the extent legally permissible, provide Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority.
In the event any Governmental Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.
Complaints . Subdistributor shall cooperate fully with Distributor and its Suppliers in dealing with any complaints concerning the Products.
Tracking . Subdistributor shall track the Products in accordance with all applicable laws and regulations.
Removals and Corrections (Recalls) . Subdistributor shall provide such assistance and information as Distributor reasonably requests in the event that Distributor and/or its Suppliers determine that a removal, correction, recall or other field action involving the Products is warranted. Without limiting the generality of the foregoing, Subdistributor shall retain, for a period of five years (or such other period as required by applicable law) after termination of this Agreement, records of all Product sales and customers sufficient to adequately administer a recall or similar action involving the Products.
Indemnification . Subject to the terms and conditions set forth in 0 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily
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injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
Non-Solicitation and Non-Circumvention
During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this 0 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this 0.
Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other purpose except solely for the benefit of and as directed by Distributor.
Limitation of Liability
NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT
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OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO DISTRIBUTOR BY SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT DURING THE TWELVE MONTH PERIOD PRIOR TO THE DATE THE CAUSE OF ACTION AROSE, REGARDLESS OF WHETHER DISTRIBUTOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Miscellaneous
Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all notices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of 0 , 0 , 0 , notice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this 0 . Except as otherwise provided in this Agreement, a notice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the notice has complied with the requirements of this 0 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: Bill McLaughlin, CFO
Attn: [_____________________]
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
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CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn:
Contracts ManagerAttn: [_____________________]
E-mail:
Kmcdonald@surgicalservice.comE-mail: [___________________]
Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement between the Parties, or otherwise.
Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under 0 or 0 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this 0 .
Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted
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granting of subdistributor rights in violation of this 0 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
Insurance. During the Term, Subdistributor shall, at its own expense, maintain and carry in full force and effect, subject to appropriate levels of self-insurance, all types and amounts of insurance required by applicable Law and all such insurance as is necessary to protect Distributor and its affiliates and their respective employees, officers and directors from and against any third party claims, including, without limitation, commercial general liability (including product liability) in a sum no less than $1,000,000 (per occurrence) and $2,000,000 (aggregate) with financially sound and reputable insurers. Upon Distributor’s request, Subdistributor shall provide Distributor with a certificate of insurance from Subdistributor’s insurer evidencing the insurance coverage specified in this Agreement. Subdistributor shall cause the certificate of insurance to name Distributor as an additional insured. Company shall provide Distributor with 30 days’ advance written notice in the event of a cancellation or material change in its insurance policy.
Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in connection with Subdistributor’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any audit shall be provided to Subdistributor in writing. Any audit will be conducted during regular business hours at Subdistributor’s business location.
Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in
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Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.4
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM Medical Consultants, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.4
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.4
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“Supplier” means the manufacturers and/or suppliers of the Product to Distributor.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.4
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.4
TERRITORY
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PRICING
|
1) |
Transfer pricing to be provided; |
|
2) |
During the length of this Agreement, If the Distributor provides billing services in behalf of the Sub-distributor due to the inability of the Sub-distributor to conduct business within a certain facility that the Distributor is able to, The Distributor will provide Sub-distributor with the following commission percentage(s); |
100% of Gross Profit after contracted transfer pricing deducted
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Exhibit 10.5
CPM MEDICAL CONSULTANTS, LLC
SALES AND DISTRIBUTION SERVICES AGREEMENT
THIS SALE AND DISTRIBUTION SERVICES AGREEMENT, dated as of March 1 st , 2018 (the “ Agreement ”), is entered into by and between CPM MEDICAL CONSULTANTS, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and _________________ ,a Texas corporation having its principal place of business at __________________________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor provides marketing, distribution and sales support services and wishes to provide Distributor with such support services; and
WHEREAS, Distributor wishes to engage Subdistributor to support its Product marketing, distribution and sales efforts on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1
Appointment
SECTION 1.1 Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive provider of the Services to Distributor in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
SECTION 1.2 Excluded Customers . Notwithstanding SECTION 1.1 , Distributor does not appoint Subdistributor as its provider of the Services for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in sales and marketing activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer. Subdistributor acknowledges and agrees that it is not entitled to any Compensation for any sale made to an Excluded Customer.
SECTION 1.3 Status as Independent Contractor .
|
(a) |
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party. |
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|
(c) |
The Distributor, to the extent applicable, shall issue Subdistributor a Form 1099 for all payments made hereunder. All taxes, withholding and the like on any and all amounts paid under this Agreement shall be solely, and absolutely the Subdistributor’s responsibility. The Subdistributor agrees that it shall indemnify, defend and hold the Distributor and its employees, affiliates, and sales representatives, harmless from and against any judgments, fines, costs or fees associated with such payments hereunder. |
ARTICLE 2
Subdistributor Obligations
SECTION 2.1 |
Services . |
Subdistributor shall perform the following Services during the Term:
(a) Sales and Marketing . Subdistributor shall market, promote, and solicit orders for the Products to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in accordance with Distributor’s Product marketing strategies, channel and pricing guidelines, and sales policies, and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor;
(b) Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a Service provider of the Distributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
(c) Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal
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business hours with general support; and assist the Distributor in training Customers, including surgeons and hospital staff members, on the proper use of the Products ;
(d) Customer Meetings . Subdistributor shall initiate and attend sales calls and meetings with prospective and existing Customers;
(e) Sales and Marketing Plan . Subdistributor shall develop and execute a sales and marketing plan in support of Distributor’s marketing strategy that will include, without limitation, identifying sales opportunities to Distributor within the Territory, and provide support to the Distributor’s contract department on an as needed basis;
(f) Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory. Subdistributor shall receive no compensation with respect to any such inquiries or orders;
(g) Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
(h) Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the Subdistributor policies applicable to Product sales, marketing, customer support, and Product pricing;
(i) Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor in accordance with Section 5.3 below. Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor.
(j) Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
(k) Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address
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and investigate, any c omplaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
(l) Recall Assistance . Subdistributor shall assist the Distributor in effectuating any recall of the Products;
(m) Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
(n) Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
(o) Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review Subdistributor’s performance, Subdistributor’s compliance with Distributor’s Code of Conduct, and other matters pertaining to this Agreement as applicable;
(p) Product Delivery and Operating Room Support . Subdistributor shall schedule the delivery of the Products to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and provide case coverage and arrange for qualified and credentialed Subdistributor Personnel are available and present in the operating room suite to provide the Products and instrumentation associated with the Products and related technical support;
(q) Charge Sheet and Purchase Orders . Subdistributor shall obtain the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker; and obtain the applicable purchase order from the hospital or clinic purchasing or procurement representative;
(r) Litigation Support . Subdistributor shall render reasonable assistance to the Distributor in the defense of any and all product liability claims;
(s) Product Specialists . Subdistributor shall employ at least one Product specialist, acceptable to Distributor, with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
(t) Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier; and
(u) Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
SECTION 2.2 Credentialing and Training .
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To ensure Subdistributor is meeting the highest standards required by Distributor , Subdistributor shall , during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the manufacturer may provide from time to time relative to the Products. In addition, the Subdistributor shall ensure that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
(a) make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
(b) engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
(c) modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
(d) offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
(e) invoice the Customer on behalf of the Distributor for Products sold;
(f) engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
(g) utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
SECTION 2.4 Compliance .
Subdistributor shall conduct its activities and perform the Services and its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such
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laws, rules or regulations, and bear all of its costs and expenses in connection therewith ; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time .
ARTICLE 3
Distributor Obligations
SECTION 3.1 |
Distributor Obligations . During the Term, Distributor shall: |
(a) Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
(b) Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
(c) Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
(d) Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement;
(e) Samples . Distributor shall provide to Subdistributor at no charge samples and prototypes that are not intended for resale. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in ARTICLE 7 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term;
(f) Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time; and
(g) Monthly Reports . Distributor shall keep records of all sales of Products through Subdistributor hereunder and submit to Subdistributor on the fifteenth day of each month a report (“ Monthly Report ”) indicating its total sales through Subdistributor hereunder for the immediately preceding month and the amount of payments received by Distributor with respect to such sales for which Subdistributor is entitled to Compensation under Schedule 4.
ARTICLE 4
Customer Orders
SECTION 4.1 Solicitation of Customer Purchase Orders . All purchase orders solicited by Subdistributor from Customers are subject to approval, rejection or modification by Distributor under
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SECTION 4.2 . Without limiting the generality of SECTION 1.3 , Subdistributor shall have no authority to enter into any Purchase Contract on behalf of Distributor or to otherwise bind Distributor to sell or deliver any Products to Customer. Subdistributor shall promptly notify Distributor with respect to all sales prospects in the Territory, including forwarding to Distributor all Customer purchase orders, requests for quotation and sales inquiries.
SECTION 4.2 Distributor’s Discretion to Accept, Modify or Reject Customer Purchase Orders . Distributor reserves the right, in its sole discretion, to: (a) accept or decline any purchase order for Products received from any party whether or not solicited by Subdistributor; (b) cancel, terminate, or modify any Purchase Contract previously accepted by Distributor; or (c) negotiate any terms and conditions of the Purchase Contract with Customer, including modifying the purchase price or payment terms.
Subdistributor acknowledges that Distributor’s exercise of discretion may result in a reduction of or a delay in the payment of Compensation owed to Subdistributor under this Agreement.
SECTION 4.3 Availability of Products . Distributor may, in its sole discretion, and without advance notice thereof: (a) change the prices, charges and terms of sale of the Products; (b) modify the Products; (c) discontinue the sale of the Products; (d) approve or reject returns, allowances or other adjustments; (e) reduce or allocate its inventory of Products; (f) and effect changes to any of the Products or parts/accessories thereto (except where continued availability is required by Law).
ARTICLE 5
Compensation
SECTION 5.1 Fees and Compensation Payment Terms .
(a) Subject to the terms of the Agreement, Subdistributor shall be compensated for the Services provided under this Agreement (the “ Compensation ”) as outlined in SCHEDULE 4.
(b) With respect to Compensation payable pursuant to SECTION 5.1(a) , Distributor shall pay Subdistributor any Compensation owed for the immediately preceding month within 15 business days of the end of such month.
(c) Distributor shall make all Compensation payments in US dollars by check or wire transfer.
(d) In addition, for purposes of clarification, Subdistributor shall not be entitled to any Compensation or other amounts: (i) for any sale made to an Excluded Customer; (ii) that contravenes any Law; or (iii) in the event Subdistributor is in breach of SECTION 2.3 of the Agreement.
SECTION 5.2 Disputes . Subdistributor shall notify Distributor in writing of any dispute regarding any Monthly Report (along with a reasonably detailed description of the dispute) within 30 days from Subdistributor’s receipt of such Monthly Report. Subdistributor will be deemed to have accepted all Monthly Reports for which Distributor does not receive timely notification of disputes. The Parties shall seek to resolve all such disputes expeditiously and in good faith. Notwithstanding anything to the contrary, Subdistributor shall continue performing its obligations under this Agreement during any such dispute.
SECTION 5.3 Setoff Right . Distributor may withhold payment of any amounts due and payable under this Agreement by reason of any setoff of any claim or dispute with Subdistributor, whether relating to Subdistributor’s breach, bankruptcy or otherwise, or in the event of any refunds, rebates or other adjustments with respect to the sale of a Product affecting previously paid Compensation. To the extent
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there are no anticipated future Compensation payments to be made under this Agreement, Subdistributor shall return any overpayme nts to the Distributor within 7 days following written demand by the Distributor .
ARTICLE 6
IP Rights
SECTION 6.1 Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).:
SECTION 6.2 Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the marketing, promotion, sale and distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
SECTION 6.3 Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
SECTION 6.4 Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
SECTION 6.5 No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
SECTION 7.1 Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to SECTION 7.2 or SECTION 7.3 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
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SECTION 7.2 Distributor ’s Right to Terminate . Distributor may terminate this Agreement by providing written n otice to Subdistributor :
(a) at any time for its convenience upon thirty (30) days prior written notice;
(b) if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
(c) immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
(d) if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
(e) if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
SECTION 7.3 Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor fails to pay any amount when due under this Agreement that is not the subject of a good faith dispute and such failure continues for 10 business days after Distributor’s receipt of written notice of nonpayment; (b) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; (c) or if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
SECTION 7.4 Effect of Expiration or Termination .
(a) Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to SECTION 13.3 and (ii) were incurred by the Parties prior to such expiration or earlier termination; provided that Distributor shall not have any obligation to pay any Compensation with respect to any Products ordered pursuant to any Purchase Contact entered into prior to expiration or termination, but shipped to Customer after such expiration or termination.
(b) Upon the expiration or earlier termination of this Agreement, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized Services provider and sales representative with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iii) permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (iv) certify in writing to Distributor that it has complied with the requirements of this SECTION 7.4(b) .
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SECTION 8.1 Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
(a) is or becomes generally available to the public other than as a result of any direct or indirect breach of this ARTICLE 8 by Subdistributor or any of its Representatives;
(b) is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
(c) was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
(d) was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
(e) is required to be disclosed pursuant to applicable Law.
SECTION 8.2 Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
(a) protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
(b) not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
(c) not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this ARTICLE 8 caused by any of its Representatives.
ARTICLE 9
Subdistributor’s Representations and Warranties
Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; and (f) when executed and delivered by each of Distributor and Subdistributor, this
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Agreement will constitute the legal, valid, and binding obligation of Subdistributor , enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity).
SECTION 10.1 Indemnification . Subject to the terms and conditions set forth in SECTION 10.2 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
SECTION 10.2 Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
SECTION 10.3 DISCLAIMER . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, DISTRIBUTOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 11
Non-Solicitation and Non-Circumvention
SECTION 11.1 During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this ARTICLE 11 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this ARTICLE 11.
SECTION 11.2 Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other
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purpose except solely for the benefit of and as directed by Distributor.
ARTICLE 12
Limitation of Liability
SECTION 12.1 NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
SECTION 12.2 MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT IN THE PRIOR 12 MONTH PERIOD.
ARTICLE 13
Miscellaneous
SECTION 13.1 Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
SECTION 13.2 Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
SECTION 13.3 Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
SECTION 13.4 Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
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SECTION 13.5 Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all n otices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of SECTION 7.1 , SECTION 7.2 , SECTION 7.3 , and Schedule 4 , n otice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this SECTION 13.4 . Except as otherwise provided in this Agreement, a n otice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the n otice has complied with the requirements of this SECTION 13.4 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC __________________________
1565 N. Central Expressway, Suite 220
__________________________
Richardson, TX 75080
__________________________
Attn: Bill McLaughlin, CFO
Attn:
_____________________
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
CPM Medical Consultants, LLC
_________________________]
1565 N. Central Expressway, Suite 220
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: ______________________
Attn: [_____________________]
E-mail:
E-mail: [___________________]
SECTION 13.6 Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
SECTION 13.7 Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
SECTION 13.8 Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
SECTION 13.9 Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
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SECTION 13.10 Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement bet ween the Parties, or otherwise.
SECTION 13.11 Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under ARTICLE 8 or ARTICLE 11 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this SECTION 13.11 .
SECTION 13.12 Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted granting of subdistributor rights in violation of this SECTION 13.12 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
SECTION 13.13 Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
SECTION 13.14 No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
SECTION 13.15 Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
SECTION 13.16 Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
SECTION 13.17 Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in
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connection with Subdistributor ’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any a udit shall be provided to Subdistributor in writing. Any a udit will be conducted during regular business hours at Subdistributor ’s business location .
SECTION 13.18 Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
SECTION 13.19 Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
SECTION 13.20 Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
SECTION 13.21 Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
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Exhibit 10.5
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM MEDICAL CONSULTANTS, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.5
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.5
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“ Services” means the marketing, distribution, and sales support services to be provided by Subdistributor as outlined in the Agreement.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.5
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.5
TERRITORY
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SCHEDULE 4
COMPENSATION
Subject to the terms and conditions of the Agreement, Distributor shall pay Subdistributor for the Services provided pursuant to this Agreement, Compensation based upon the following methodologies (which the Parties agree reflects fair value for the Services being provided pursuant to this Agreement):
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Rev 102017a
Exhibit 10.6
CPM MEDICAL CONSULTANTS, LLC
STOCKING AND SUBDISTRIBUTION AGREEMENT
THIS STOCKING AND SUBDISTRIBUTION AGREEMENT, dated as of [_______________, 20____] (the “ Agreement ”), is entered into by and between CPM Medical Consultants, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and [___________________________], a [______________] corporation having its principal place of business at _____________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor is in the business of distributing medical products and wishes to distribute the Products within the Territory; and
WHEREAS, Distributor wishes to engage Subdistributor to provide supplemental Product distribution on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Appointment
Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive subdistributor to Distributor of the Products in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
Excluded Customers . Notwithstanding 0 , Distributor does not appoint Subdistributor as its subdistributor of the Products for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in Product subdistribution activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer.
Status as Independent Contractor .
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party.
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The operations of Subdistributor are subject to the sole control of Subdistributor. Subdistributor is solely responsible for its Personnel and there are no joint employment relationships with Distributor regarding such Personnel by virtue of this Agreement. Without limitation of the foregoing, Subdistributor is solely responsible for, at its own expense: (i) providing such office space and facilities, and such Personnel (and their training) as may be necessary to carry out its obligations under this Agreement; (ii) compensating all Subdistributor Personnel for any services rendered in connection with the performance of its obligations under this Agreement; (iii) covering all Personnel under any applicable social benefit laws (including workers’ compensation and applicable state disability insurance) and obtaining any other customary insurance pertaining to Subdistributor’s operations and Personnel; and (iv) making any and all payroll deductions and contributions that may be required by Law or otherwise with respect to the Personnel. Subdistributor shall be solely responsible for any and all costs or expenses that it may incur in the performance of its obligations under this Agreement.
Reserved.
Subdistributor Obligations
Subdistribution .
Subdistributor shall perform the following during the Term:
Subdistributor . Subdistributor shall market, promote, and solicit orders for the Products as a subdistributor to Distributor to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in a manner consistent with Distributor’s Product marketing strategies and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor and its Suppliers;
Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a subdistributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal business hours with general support; and train Customers, including surgeons and hospital staff members, on the proper use of the Products;
Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory;
Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
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Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor or otherwise made available by Distributor’s Suppliers in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the respective policies of Distributor and its Suppliers applicable to Product distribution;;
Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
Recall Assistance . Subdistributor shall assist the Distributor and its Suppliers in effectuating any recall of the Products;
Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review matters pertaining to this Agreement as applicable;
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Product Delivery and Operating Room Support . Subdistributor shall be solely responsible for (i) scheduling the delivery of Products that it is distributing to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and (ii) providing case coverage and arranging for qualified and credentialed Subdistributor Personnel to be available and present in the operating room suite to provide the Products and applicable instrumentation associated with the Products and related Product technical support;
Litigation Support . Subdistributor shall render reasonable assistance to the Distributor and its Suppliers in the defense of any and all product liability claims;
Product Specialists . Subdistributor shall employ at least one Product specialist with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier;
Records and Audit . Subdistributor shall maintain records of its purchasing activities (including copies of the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker) and shall provide a copy of such records or otherwise make such records available to Distributor at Distributor’s request and election. Subdistributor shall also submit to Distributor, on a quarterly basis, a report containing detailed information, by Product, on Subdistributor’s customers, sales, and subdistribution activities in the preceding quarter, as well as a forecast of its approximate requirements for the Products for the subsequent four quarters. Distributor shall have the right to audit and inspect Subdistributor’s Product inventory and the records maintained by Subdistributor at any time and from time to time upon reasonable advance notice. Subdistributor agrees to fully cooperate with and assist Distributor in such inspections and audits; and
Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
Credentialing and Training .
To ensure Subdistributor is meeting the highest standards required by Distributor and its Suppliers, Subdistributor shall, during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the Supplier may provide from time to time relative to the Products. In addition, the Subdistributor shall be solely responsible for ensuring that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
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make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
generate any invoices on behalf of the Distributor for Products sold;
engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
Distributor Obligations
Distributor Obligations . During the Term, Distributor shall:
Shipment of Products and Instruments . Subject to Product availability and the terms and conditions of this Agreement, Distributor shall use reasonable efforts to fill Subdistributor’s orders for Products and Instruments, which are accepted by Distributor. It is understood by the Parties that expected delivery times will vary according to manufacturing and other conditions and that all delivery dates are estimates.
Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives and/or authorized subdistributors of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
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Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement to the extent such information and material is made available to Distributor by its Suppliers;
Samples . Distributor shall provide to Subdistributor samples and prototypes that are not intended for resale to the extent such are made available by its Suppliers and at the same cost (if any) assessed by its Suppliers. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in 0 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term; and
Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time.
Orders for Products and Instruments
Purchase Orders .
Subdistributor shall submit to Distributor written purchase orders for the Products and Instruments it elects to purchase and distribute pursuant to this Agreement, which orders shall include: (i) a list of the Products and Instruments ordered, (ii) the quantities of such Products and Instruments, and (iii) precise instructions for packaging, invoicing and shipping.
Consigned Inventory. Subdistributor may elect to order Product and Instrument stocking inventory on a consigned basis. Such orders for consigned inventory shall be subject to acceptance by Distributor and shall remain the property of Distributor until such time as the consigned inventory has been purchased.
Shipment Terms .
Subject to receipt and acceptance by Distributor of an order for purchase or consignment, unless otherwise agreed in writing, shipments, whether for purchased or consigned Product, shall be F.O.B. Distributor’s facility in Richardson, TX. Distributor shall not be obligated to make direct shipments to Subdistributor’s customers, unless otherwise agreed by the Parties. Distributor’s obligation to effect shipment of the Products and Instruments shall be fully discharged and all title (for purchased items) and risk of loss or damage (for all items) shall pass to Subdistributor when the Products and the Instruments are delivered to a carrier for shipment to Subdistributor. In addition, Subdistributor shall pay all charges, including, without limitation, all transportation charges and insurance premiums associated with the shipment and purchasing of the Products.
Modification or Cancellation of Orders .
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No accepted order shall be cancelled or modified except upon the written agreement of both Parties. Subdistributor’s orders or mutually agreed change orders shall be subject to all of the terms and conditions of this Agreement, whether or not the order or change order so states. In the event Subdistributor cancels an order after such order has been accepted by Distributor, Subdistributor shall reimburse Distributor for all costs incurred as a result of such order.
Product and Policy Changes .
Distributor reserves the right from time to time and in its discretion, without incurring any liability to Subdistributor: (i) to discontinue or limit its distribution of any Product; (ii) to allocate or to terminate or limit deliveries of any Product; (iii) to alter the design or construction of any Product or Instrument; (iv) to add new and additional Products; and (v) upon reasonable notice to Subdistributor, change its sales and purchasing policies to the extent that such changes are not inconsistent with the terms of this Agreement.
No Shipment Obligation .
Distributor shall not be obligated to make any shipment if such shipment could, at the time thereof, constitute a violation of any laws, regulations or policies.
Acceptance of Products and Instruments .
Subdistributor shall conduct any incoming inspections or acceptance tests as soon as possible upon arrival of the Products or Instruments at the shipping address, but in no event later than ten (10) days from the date of receipt. Any Products or Instruments not rejected by Subdistributor by written notice to Distributor within such period shall be deemed accepted. Subdistributor shall promptly report to Distributor any shortage, damage, or discrepancy in or to a shipment of Products or Instruments discovered by Subdistributor during such ten (10) day acceptance period and furnish written evidence or other documentation that Distributor deems appropriate. If the substantiating evidence delivered by Subdistributor demonstrates to Distributor’s satisfaction that such shortage, damage or discrepancy existed at the time of delivery of the Products or Instruments to the carrier, Distributor shall, at its discretion, promptly deliver additional or substitute Products or Instruments to Subdistributor at Distributor’s expense or issue a credit to Subdistributor.
Product Return .
Except as provided in this Section, Subdistributor may not return any Product to Distributor for any reason without Distributor’s prior written consent. Further, the following shall apply: (a) Sterile merchandise, which has been opened, has a breach of the package integrity, or has otherwise been damaged, will not be credited upon return; (b) special order or custom items will not be credited upon return; (c) obsolete merchandise not listed in Distributor’s then-current Product catalogs cannot be returned; and (d) items with an expired shelf life or sterile expiration date cannot be returned.
Price and Payment
Price. Subdistributor shall pay for the Products and the Instruments purchased under this Agreement at the prices set forth on Distributor’s then current price list. All prices include packing in accordance with Distributor’s standard practices in effect at the time of shipment. Special packing or handling shall be at
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the sole expense of Subdistributor.
Price Changes. Pricing for all Products shall remain in effect during the term of this Agreement unless mutually agreed upon in writing by both Distributor and Subdistributor. In the event that Distributor reduces the price of the Products or the Instruments ordered by Subdistributor, Distributor may, in its sole discretion and upon Subdistributor’s written request within thirty (30) days of each shipment, issue a credit to Subdistributor in the amount of the price reduction applicable to that shipment.
Payment. Subdistributor shall pay for the Products and the Instruments within thirty (30) days of receipt of invoice for said Products or Instruments.
Taxes . Subdistributor is responsible for and shall pay or reimburse Distributor for all taxes (except Distributor’s net income taxes), duties, assessments and other governmental charges, however designated, associated with the purchase and purchasing of Products and the performance of this Agreement.
Subdistributor Warranties . Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; (f) when executed and delivered by each of Distributor and Subdistributor, this Agreement will constitute the legal, valid, and binding obligation of Subdistributor, enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity); (g) Subdistributor shall conduct its activities and perform its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such laws, rules or regulations, and bear all of its costs and expenses in connection therewith; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time.
No Inconsistent Warranties . Subdistributor shall not make any claims or representations concerning the Products that are inconsistent with those made by Distributor or its Suppliers.
Supplier Warranties . The warranties made by Supplier with respect to each Product are solely those that are contained in the product insert accompanying such Product. No other affirmation of fact or promise made by Distributor or its Suppliers, whether or not in this Agreement, by words
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or action shall constitute a warranty. The foregoing warranty does not extend to any Product that is modified or altered, or treated with abuse, negligence or other improper treatment.
Standard Limited Warranty. Distributor shall pass on to Subdistributor so that it may pass on to the customers the Supplier's standard limited warranty for Products, including limitations set for in subsection (b) Limitation of Liability and Warranty below. Except for the stated warranty set forth on, or included with, the Products as delivered to the Subdistributor and /or its customers, the warranty and remedy set forth in this 0 are exclusive and all other warranties, guarantees or representations, express or implied, by Distributor’s Suppliers with respect to the applicable Products, including, without limitation, warranties of merchantability and fitness for particular purpose, and any other obligation or liability of Distributor and its Suppliers to Subdistributor or to any third party with respect to the Products, are hereby excluded. This warranty is contingent upon proper use of a Product in the application for which such Product was intended and does not cover Products that were modified without Distributor or its Supplier’s prior written approval, that have expired or that were subjected to physical, chemical or electrical stress that the products were not originally designed for.
Limitation of Liability and Warranty. Distributor and its Suppliers’ liability arising out of this agreement and/or sale of the products shall be limited as follows: in no event shall Distributor and its Suppliers be liable for costs of the procurement of substitute goods by anyone. In no event shall Distributor and its Suppliers be liable to Subdistributor or any other entity for any special, consequential, incidental, or indirect damages, however caused, on any theory of liability or breach of warranty, whether or not Distributor and its Suppliers have been advised on the possibility. Except for the express limited warranty set forth in previous subsection (a) Standard Limited Warranty above, Distributor and its Suppliers grant no implied warranties for the Products, either in fact or by operation of law, by statute, or otherwise.
Warranty Disclaimer . EXCEPT AS EXPRESSLY PROVIDED HEREIN, DISTRIBUTOR AND ITS SUPPLIERS MAKE NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD, CONSIGNED OR LOANED OR OTHERWISE DISTRIBUTED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
IP Rights
Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).
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Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor and in accordance with the Supplier guidelines relative to such Product marketing. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to 0 or 0 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
Distributor’s Right to Terminate . Distributor may terminate this Agreement by providing written notice to Subdistributor:
at any time for its convenience upon thirty (30) days prior written notice;
if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee,
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receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; or (b) if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
Effect of Expiration or Termination .
Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to 0 and (ii) were incurred by the Parties prior to such expiration or earlier termination.
Upon the expiration or earlier termination of this Agreement, and subject to Distributor elections set forth in subsection (c) below, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized subdistributor with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) make arrangements with Distributor relative to the handling and return of any consigned Products or Instruments; (iii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iv) to the extent legally permissible to do so, permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (v) certify in writing to Distributor that it has complied with the requirements of this 0. In the event (i) Subdistributor does not immediately return all such consigned Products and Instruments, or (ii) Distributor, in its discretion, determines that the consigned Products and Instruments that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Products and Instrument price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any consigned Products or Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon return and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subject to all of the terms and conditions of this Agreement, upon any termination or expiration of this Agreement for any reason whatsoever, Subdistributor shall retain the non-exclusive right to distribute the remaining Products that it purchased and remain in its inventory on the date of termination for 12 months (and all of the terms and conditions of this Agreement shall continue to apply during such 12 month period), unless Distributor exercises the option in the following sentence. Distributor shall have the option at any time after expiration or termination of this Agreement to immediately terminate Subdistributor’s rights to distribute its purchased inventory by repurchasing Subdistributor’s purchased inventory of Products at the
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price Subdistributor paid for that inventory and payment of Distributor’s then-current restocking fees applicable to such Products. Notwithstanding the foregoing, in no event shall Distributor have any obligation to repurchase Subdistributor’s purchased inventory.
Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
is or becomes generally available to the public other than as a result of any direct or indirect breach of this 0 by Subdistributor or any of its Representatives;
is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
is required to be disclosed pursuant to applicable Law.
Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this 0 caused by any of its Representatives.
Regulatory Matters
Medical Device Reporting Requirements . Subdistributor shall provide such assistance and information as Distributor and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor shall: (1) immediately
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transmit to Distributor all oral or written complaints regarding the Products that are received by Subdistributor; (2) keep and maintain a record of all customer complaints received by Subdistributor relating to the Products that are required to be maintained by Subdistributor pursuant to 21 C.F.R. § 803.18; (3) notify Distributor upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor and its Suppliers. It is the sole responsibility of Distributor and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territory. Notwithstanding the foregoing, in the event that Subdistributor is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor from doing so; provided, however, that Subdistributor shall immediately provide Distributor with prior notice of such reporting (to the extent legally permissible) and provide Distributor with copies of any such filings or reports (to the extent legally permissible).
Compliance with U.S. Food and Drug Administration Recall Policy . In order to assure compliance with FDA Recall policies, the Subdistributor will provide Distributor with a record of each surgery in which Distributor’s Suppliers’ respective Products sold to Subdistributor have been implanted. Distributor and Subdistributor will fully comply with all requirements of HIPAA including safeguarding the names and medical records of patients. The information required to be reported to Distributor by Subdistributor will be the Hospital Proof of Delivery form or a Charge Sheet from the Subdistributor which must include the date of surgery, the name of the hospital in which the surgery was performed, the name of the surgeon performing the surgery and a list of products implanted by unit catalog number, lot number and sterility expiration date. The first name and first initial of the patient’s last name will also be included, but the full name of the patient will be retained by Subdistributor and immediately reported to Distributor in the event of an actual recall of the implanted products. Failure of the Subdistributor to provide this information may cause Distributor to delay shipment of replacement / restock products to Subdistributor until such information has been provided.
Governmental Inspections and Inquiries . Subdistributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor in writing of, and shall provide Distributor with copies of, any correspondence and other documentation received or prepared by the Subdistributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority:
Receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the storage, marketing, advertisement, sale and/or purchasing of the Product(s); and
Any Governmental or Regulatory Authority’s comments relating to the Product(s) that may require a response or action by Distributor.
Without limiting the generality of the foregoing, in the event that the Subdistributor or any of its Representatives receive a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Product(s) that requires a response or action by Distributor and/or its Suppliers, the Subdistributor shall promptly provide to Distributor any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing of the Product(s), and the Subdistributor will cooperate fully with Distributor in preparing such response.
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In the event any facility that is used by the Subdistributor or any of its Representatives to store, market advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor shall notify the Distributor promptly upon learning of such inspection and shall supply Distributor with copies of any correspondence that relates to such inspection. Distributor may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Product(s). The Subdistributor shall (to the extent legally permissible) furnish to Distributor copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with five (5) business days after the delivery of such information by the Governmental or Regulatory Authority.
The Distributor shall, at its discretion and to the extent legally permissible, provide Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority.
In the event any Governmental Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.
Complaints . Subdistributor shall cooperate fully with Distributor and its Suppliers in dealing with any complaints concerning the Products.
Tracking . Subdistributor shall track the Products in accordance with all applicable laws and regulations.
Removals and Corrections (Recalls) . Subdistributor shall provide such assistance and information as Distributor reasonably requests in the event that Distributor and/or its Suppliers determine that a removal, correction, recall or other field action involving the Products is warranted. Without limiting the generality of the foregoing, Subdistributor shall retain, for a period of five years (or such other period as required by applicable law) after termination of this Agreement, records of all Product sales and customers sufficient to adequately administer a recall or similar action involving the Products.
Indemnification . Subject to the terms and conditions set forth in 0 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily
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injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
Non-Solicitation and Non-Circumvention
During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this 0 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this 0.
Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other purpose except solely for the benefit of and as directed by Distributor.
Limitation of Liability
NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT
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OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO DISTRIBUTOR BY SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT DURING THE TWELVE MONTH PERIOD PRIOR TO THE DATE THE CAUSE OF ACTION AROSE, REGARDLESS OF WHETHER DISTRIBUTOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Miscellaneous
Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all notices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of 0 , 0 , 0 , notice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this 0 . Except as otherwise provided in this Agreement, a notice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the notice has complied with the requirements of this 0 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: Bill McLaughlin, CFO
Attn: [_____________________]
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
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CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn:
Contracts ManagerAttn: [_____________________]
E-mail:
Kmcdonald@surgicalservice.comE-mail: [___________________]
Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement between the Parties, or otherwise.
Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under 0 or 0 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this 0 .
Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted
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granting of subdistributor rights in violation of this 0 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
Insurance. During the Term, Subdistributor shall, at its own expense, maintain and carry in full force and effect, subject to appropriate levels of self-insurance, all types and amounts of insurance required by applicable Law and all such insurance as is necessary to protect Distributor and its affiliates and their respective employees, officers and directors from and against any third party claims, including, without limitation, commercial general liability (including product liability) in a sum no less than $1,000,000 (per occurrence) and $2,000,000 (aggregate) with financially sound and reputable insurers. Upon Distributor’s request, Subdistributor shall provide Distributor with a certificate of insurance from Subdistributor’s insurer evidencing the insurance coverage specified in this Agreement. Subdistributor shall cause the certificate of insurance to name Distributor as an additional insured. Company shall provide Distributor with 30 days’ advance written notice in the event of a cancellation or material change in its insurance policy.
Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in connection with Subdistributor’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any audit shall be provided to Subdistributor in writing. Any audit will be conducted during regular business hours at Subdistributor’s business location.
Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in
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Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.6
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM Medical Consultants, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.6
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.6
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“Supplier” means the manufacturers and/or suppliers of the Product to Distributor.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.6
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.6
TERRITORY
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PRICING
|
1) |
Transfer pricing to be provided; |
|
2) |
During the length of this Agreement, If the Distributor provides billing services in behalf of the Sub-distributor due to the inability of the Sub-distributor to conduct business within a certain facility that the Distributor is able to, The Distributor will provide Sub-distributor with the following commission percentage(s); |
100% of Gross Profit after contracted transfer pricing deducted
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Exhibit 10.7
CPM MEDICAL CONSULTANTS, LLC
STOCKING AND SUBDISTRIBUTION AGREEMENT
THIS STOCKING AND SUBDISTRIBUTION AGREEMENT, dated as of [_______________, 20____] (the “ Agreement ”), is entered into by and between CPM Medical Consultants, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and [___________________________], a [______________] corporation having its principal place of business at _____________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor is in the business of distributing medical products and wishes to distribute the Products within the Territory; and
WHEREAS, Distributor wishes to engage Subdistributor to provide supplemental Product distribution on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Appointment
Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive subdistributor to Distributor of the Products in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
Excluded Customers . Notwithstanding 0 , Distributor does not appoint Subdistributor as its subdistributor of the Products for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in Product subdistribution activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer.
Status as Independent Contractor .
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party.
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The operations of Subdistributor are subject to the sole control of Subdistributor. Subdistributor is solely responsible for its Personnel and there are no joint employment relationships with Distributor regarding such Personnel by virtue of this Agreement. Without limitation of the foregoing, Subdistributor is solely responsible for, at its own expense: (i) providing such office space and facilities, and such Personnel (and their training) as may be necessary to carry out its obligations under this Agreement; (ii) compensating all Subdistributor Personnel for any services rendered in connection with the performance of its obligations under this Agreement; (iii) covering all Personnel under any applicable social benefit laws (including workers’ compensation and applicable state disability insurance) and obtaining any other customary insurance pertaining to Subdistributor’s operations and Personnel; and (iv) making any and all payroll deductions and contributions that may be required by Law or otherwise with respect to the Personnel. Subdistributor shall be solely responsible for any and all costs or expenses that it may incur in the performance of its obligations under this Agreement.
Reserved.
Subdistributor Obligations
Subdistribution .
Subdistributor shall perform the following during the Term:
Subdistributor . Subdistributor shall market, promote, and solicit orders for the Products as a subdistributor to Distributor to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in a manner consistent with Distributor’s Product marketing strategies and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor and its Suppliers;
Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a subdistributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal business hours with general support; and train Customers, including surgeons and hospital staff members, on the proper use of the Products;
Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory;
Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
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Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor or otherwise made available by Distributor’s Suppliers in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the respective policies of Distributor and its Suppliers applicable to Product distribution;;
Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
Recall Assistance . Subdistributor shall assist the Distributor and its Suppliers in effectuating any recall of the Products;
Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review matters pertaining to this Agreement as applicable;
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Product Delivery and Operating Room Support . Subdistributor shall be solely responsible for (i) scheduling the delivery of Products that it is distributing to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and (ii) providing case coverage and arranging for qualified and credentialed Subdistributor Personnel to be available and present in the operating room suite to provide the Products and applicable instrumentation associated with the Products and related Product technical support;
Litigation Support . Subdistributor shall render reasonable assistance to the Distributor and its Suppliers in the defense of any and all product liability claims;
Product Specialists . Subdistributor shall employ at least one Product specialist with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier;
Records and Audit . Subdistributor shall maintain records of its purchasing activities (including copies of the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker) and shall provide a copy of such records or otherwise make such records available to Distributor at Distributor’s request and election. Subdistributor shall also submit to Distributor, on a quarterly basis, a report containing detailed information, by Product, on Subdistributor’s customers, sales, and subdistribution activities in the preceding quarter, as well as a forecast of its approximate requirements for the Products for the subsequent four quarters. Distributor shall have the right to audit and inspect Subdistributor’s Product inventory and the records maintained by Subdistributor at any time and from time to time upon reasonable advance notice. Subdistributor agrees to fully cooperate with and assist Distributor in such inspections and audits; and
Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
Credentialing and Training .
To ensure Subdistributor is meeting the highest standards required by Distributor and its Suppliers, Subdistributor shall, during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the Supplier may provide from time to time relative to the Products. In addition, the Subdistributor shall be solely responsible for ensuring that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
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make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
generate any invoices on behalf of the Distributor for Products sold;
engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
Distributor Obligations
Distributor Obligations . During the Term, Distributor shall:
Shipment of Products and Instruments . Subject to Product availability and the terms and conditions of this Agreement, Distributor shall use reasonable efforts to fill Subdistributor’s orders for Products and Instruments, which are accepted by Distributor. It is understood by the Parties that expected delivery times will vary according to manufacturing and other conditions and that all delivery dates are estimates.
Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives and/or authorized subdistributors of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
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Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement to the extent such information and material is made available to Distributor by its Suppliers;
Samples . Distributor shall provide to Subdistributor samples and prototypes that are not intended for resale to the extent such are made available by its Suppliers and at the same cost (if any) assessed by its Suppliers. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in 0 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term; and
Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time.
Orders for Products and Instruments
Purchase Orders .
Subdistributor shall submit to Distributor written purchase orders for the Products and Instruments it elects to purchase and distribute pursuant to this Agreement, which orders shall include: (i) a list of the Products and Instruments ordered, (ii) the quantities of such Products and Instruments, and (iii) precise instructions for packaging, invoicing and shipping.
Consigned Inventory. Subdistributor may elect to order Product and Instrument stocking inventory on a consigned basis. Such orders for consigned inventory shall be subject to acceptance by Distributor and shall remain the property of Distributor until such time as the consigned inventory has been purchased.
Shipment Terms .
Subject to receipt and acceptance by Distributor of an order for purchase or consignment, unless otherwise agreed in writing, shipments, whether for purchased or consigned Product, shall be F.O.B. Distributor’s facility in Richardson, TX. Distributor shall not be obligated to make direct shipments to Subdistributor’s customers, unless otherwise agreed by the Parties. Distributor’s obligation to effect shipment of the Products and Instruments shall be fully discharged and all title (for purchased items) and risk of loss or damage (for all items) shall pass to Subdistributor when the Products and the Instruments are delivered to a carrier for shipment to Subdistributor. In addition, Subdistributor shall pay all charges, including, without limitation, all transportation charges and insurance premiums associated with the shipment and purchasing of the Products.
Modification or Cancellation of Orders .
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No accepted order shall be cancelled or modified except upon the written agreement of both Parties. Subdistributor’s orders or mutually agreed change orders shall be subject to all of the terms and conditions of this Agreement, whether or not the order or change order so states. In the event Subdistributor cancels an order after such order has been accepted by Distributor, Subdistributor shall reimburse Distributor for all costs incurred as a result of such order.
Product and Policy Changes .
Distributor reserves the right from time to time and in its discretion, without incurring any liability to Subdistributor: (i) to discontinue or limit its distribution of any Product; (ii) to allocate or to terminate or limit deliveries of any Product; (iii) to alter the design or construction of any Product or Instrument; (iv) to add new and additional Products; and (v) upon reasonable notice to Subdistributor, change its sales and purchasing policies to the extent that such changes are not inconsistent with the terms of this Agreement.
No Shipment Obligation .
Distributor shall not be obligated to make any shipment if such shipment could, at the time thereof, constitute a violation of any laws, regulations or policies.
Acceptance of Products and Instruments .
Subdistributor shall conduct any incoming inspections or acceptance tests as soon as possible upon arrival of the Products or Instruments at the shipping address, but in no event later than ten (10) days from the date of receipt. Any Products or Instruments not rejected by Subdistributor by written notice to Distributor within such period shall be deemed accepted. Subdistributor shall promptly report to Distributor any shortage, damage, or discrepancy in or to a shipment of Products or Instruments discovered by Subdistributor during such ten (10) day acceptance period and furnish written evidence or other documentation that Distributor deems appropriate. If the substantiating evidence delivered by Subdistributor demonstrates to Distributor’s satisfaction that such shortage, damage or discrepancy existed at the time of delivery of the Products or Instruments to the carrier, Distributor shall, at its discretion, promptly deliver additional or substitute Products or Instruments to Subdistributor at Distributor’s expense or issue a credit to Subdistributor.
Product Return .
Except as provided in this Section, Subdistributor may not return any Product to Distributor for any reason without Distributor’s prior written consent. Further, the following shall apply: (a) Sterile merchandise, which has been opened, has a breach of the package integrity, or has otherwise been damaged, will not be credited upon return; (b) special order or custom items will not be credited upon return; (c) obsolete merchandise not listed in Distributor’s then-current Product catalogs cannot be returned; and (d) items with an expired shelf life or sterile expiration date cannot be returned.
Price and Payment
Price. Subdistributor shall pay for the Products and the Instruments purchased under this Agreement at the prices set forth on Distributor’s then current price list. All prices include packing in accordance with Distributor’s standard practices in effect at the time of shipment. Special packing or handling shall be at
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the sole expense of Subdistributor.
Price Changes. Pricing for all Products shall remain in effect during the term of this Agreement unless mutually agreed upon in writing by both Distributor and Subdistributor. In the event that Distributor reduces the price of the Products or the Instruments ordered by Subdistributor, Distributor may, in its sole discretion and upon Subdistributor’s written request within thirty (30) days of each shipment, issue a credit to Subdistributor in the amount of the price reduction applicable to that shipment.
Payment. Subdistributor shall pay for the Products and the Instruments within thirty (30) days of receipt of invoice for said Products or Instruments.
Taxes . Subdistributor is responsible for and shall pay or reimburse Distributor for all taxes (except Distributor’s net income taxes), duties, assessments and other governmental charges, however designated, associated with the purchase and purchasing of Products and the performance of this Agreement.
Subdistributor Warranties . Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; (f) when executed and delivered by each of Distributor and Subdistributor, this Agreement will constitute the legal, valid, and binding obligation of Subdistributor, enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity); (g) Subdistributor shall conduct its activities and perform its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such laws, rules or regulations, and bear all of its costs and expenses in connection therewith; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time.
No Inconsistent Warranties . Subdistributor shall not make any claims or representations concerning the Products that are inconsistent with those made by Distributor or its Suppliers.
Supplier Warranties . The warranties made by Supplier with respect to each Product are solely those that are contained in the product insert accompanying such Product. No other affirmation of fact or promise made by Distributor or its Suppliers, whether or not in this Agreement, by words
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or action shall constitute a warranty. The foregoing warranty does not extend to any Product that is modified or altered, or treated with abuse, negligence or other improper treatment.
Standard Limited Warranty. Distributor shall pass on to Subdistributor so that it may pass on to the customers the Supplier's standard limited warranty for Products, including limitations set for in subsection (b) Limitation of Liability and Warranty below. Except for the stated warranty set forth on, or included with, the Products as delivered to the Subdistributor and /or its customers, the warranty and remedy set forth in this 0 are exclusive and all other warranties, guarantees or representations, express or implied, by Distributor’s Suppliers with respect to the applicable Products, including, without limitation, warranties of merchantability and fitness for particular purpose, and any other obligation or liability of Distributor and its Suppliers to Subdistributor or to any third party with respect to the Products, are hereby excluded. This warranty is contingent upon proper use of a Product in the application for which such Product was intended and does not cover Products that were modified without Distributor or its Supplier’s prior written approval, that have expired or that were subjected to physical, chemical or electrical stress that the products were not originally designed for.
Limitation of Liability and Warranty. Distributor and its Suppliers’ liability arising out of this agreement and/or sale of the products shall be limited as follows: in no event shall Distributor and its Suppliers be liable for costs of the procurement of substitute goods by anyone. In no event shall Distributor and its Suppliers be liable to Subdistributor or any other entity for any special, consequential, incidental, or indirect damages, however caused, on any theory of liability or breach of warranty, whether or not Distributor and its Suppliers have been advised on the possibility. Except for the express limited warranty set forth in previous subsection (a) Standard Limited Warranty above, Distributor and its Suppliers grant no implied warranties for the Products, either in fact or by operation of law, by statute, or otherwise.
Warranty Disclaimer . EXCEPT AS EXPRESSLY PROVIDED HEREIN, DISTRIBUTOR AND ITS SUPPLIERS MAKE NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD, CONSIGNED OR LOANED OR OTHERWISE DISTRIBUTED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
IP Rights
Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).
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Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor and in accordance with the Supplier guidelines relative to such Product marketing. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to 0 or 0 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
Distributor’s Right to Terminate . Distributor may terminate this Agreement by providing written notice to Subdistributor:
at any time for its convenience upon thirty (30) days prior written notice;
if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee,
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receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; or (b) if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
Effect of Expiration or Termination .
Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to 0 and (ii) were incurred by the Parties prior to such expiration or earlier termination.
Upon the expiration or earlier termination of this Agreement, and subject to Distributor elections set forth in subsection (c) below, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized subdistributor with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) make arrangements with Distributor relative to the handling and return of any consigned Products or Instruments; (iii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iv) to the extent legally permissible to do so, permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (v) certify in writing to Distributor that it has complied with the requirements of this 0. In the event (i) Subdistributor does not immediately return all such consigned Products and Instruments, or (ii) Distributor, in its discretion, determines that the consigned Products and Instruments that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Products and Instrument price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any consigned Products or Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon return and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subject to all of the terms and conditions of this Agreement, upon any termination or expiration of this Agreement for any reason whatsoever, Subdistributor shall retain the non-exclusive right to distribute the remaining Products that it purchased and remain in its inventory on the date of termination for 12 months (and all of the terms and conditions of this Agreement shall continue to apply during such 12 month period), unless Distributor exercises the option in the following sentence. Distributor shall have the option at any time after expiration or termination of this Agreement to immediately terminate Subdistributor’s rights to distribute its purchased inventory by repurchasing Subdistributor’s purchased inventory of Products at the
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price Subdistributor paid for that inventory and payment of Distributor’s then-current restocking fees applicable to such Products. Notwithstanding the foregoing, in no event shall Distributor have any obligation to repurchase Subdistributor’s purchased inventory.
Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
is or becomes generally available to the public other than as a result of any direct or indirect breach of this 0 by Subdistributor or any of its Representatives;
is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
is required to be disclosed pursuant to applicable Law.
Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this 0 caused by any of its Representatives.
Regulatory Matters
Medical Device Reporting Requirements . Subdistributor shall provide such assistance and information as Distributor and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor shall: (1) immediately
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transmit to Distributor all oral or written complaints regarding the Products that are received by Subdistributor; (2) keep and maintain a record of all customer complaints received by Subdistributor relating to the Products that are required to be maintained by Subdistributor pursuant to 21 C.F.R. § 803.18; (3) notify Distributor upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor and its Suppliers. It is the sole responsibility of Distributor and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territory. Notwithstanding the foregoing, in the event that Subdistributor is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor from doing so; provided, however, that Subdistributor shall immediately provide Distributor with prior notice of such reporting (to the extent legally permissible) and provide Distributor with copies of any such filings or reports (to the extent legally permissible).
Compliance with U.S. Food and Drug Administration Recall Policy . In order to assure compliance with FDA Recall policies, the Subdistributor will provide Distributor with a record of each surgery in which Distributor’s Suppliers’ respective Products sold to Subdistributor have been implanted. Distributor and Subdistributor will fully comply with all requirements of HIPAA including safeguarding the names and medical records of patients. The information required to be reported to Distributor by Subdistributor will be the Hospital Proof of Delivery form or a Charge Sheet from the Subdistributor which must include the date of surgery, the name of the hospital in which the surgery was performed, the name of the surgeon performing the surgery and a list of products implanted by unit catalog number, lot number and sterility expiration date. The first name and first initial of the patient’s last name will also be included, but the full name of the patient will be retained by Subdistributor and immediately reported to Distributor in the event of an actual recall of the implanted products. Failure of the Subdistributor to provide this information may cause Distributor to delay shipment of replacement / restock products to Subdistributor until such information has been provided.
Governmental Inspections and Inquiries . Subdistributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor in writing of, and shall provide Distributor with copies of, any correspondence and other documentation received or prepared by the Subdistributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority:
Receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the storage, marketing, advertisement, sale and/or purchasing of the Product(s); and
Any Governmental or Regulatory Authority’s comments relating to the Product(s) that may require a response or action by Distributor.
Without limiting the generality of the foregoing, in the event that the Subdistributor or any of its Representatives receive a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Product(s) that requires a response or action by Distributor and/or its Suppliers, the Subdistributor shall promptly provide to Distributor any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing of the Product(s), and the Subdistributor will cooperate fully with Distributor in preparing such response.
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In the event any facility that is used by the Subdistributor or any of its Representatives to store, market advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor shall notify the Distributor promptly upon learning of such inspection and shall supply Distributor with copies of any correspondence that relates to such inspection. Distributor may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Product(s). The Subdistributor shall (to the extent legally permissible) furnish to Distributor copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with five (5) business days after the delivery of such information by the Governmental or Regulatory Authority.
The Distributor shall, at its discretion and to the extent legally permissible, provide Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority.
In the event any Governmental Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.
Complaints . Subdistributor shall cooperate fully with Distributor and its Suppliers in dealing with any complaints concerning the Products.
Tracking . Subdistributor shall track the Products in accordance with all applicable laws and regulations.
Removals and Corrections (Recalls) . Subdistributor shall provide such assistance and information as Distributor reasonably requests in the event that Distributor and/or its Suppliers determine that a removal, correction, recall or other field action involving the Products is warranted. Without limiting the generality of the foregoing, Subdistributor shall retain, for a period of five years (or such other period as required by applicable law) after termination of this Agreement, records of all Product sales and customers sufficient to adequately administer a recall or similar action involving the Products.
Indemnification . Subject to the terms and conditions set forth in 0 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily
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injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
Non-Solicitation and Non-Circumvention
During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this 0 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this 0.
Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other purpose except solely for the benefit of and as directed by Distributor.
Limitation of Liability
NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT
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OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO DISTRIBUTOR BY SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT DURING THE TWELVE MONTH PERIOD PRIOR TO THE DATE THE CAUSE OF ACTION AROSE, REGARDLESS OF WHETHER DISTRIBUTOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Miscellaneous
Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all notices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of 0 , 0 , 0 , notice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this 0 . Except as otherwise provided in this Agreement, a notice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the notice has complied with the requirements of this 0 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: Bill McLaughlin, CFO
Attn: [_____________________]
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
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CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn:
Contracts ManagerAttn: [_____________________]
E-mail:
Kmcdonald@surgicalservice.comE-mail: [___________________]
Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement between the Parties, or otherwise.
Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under 0 or 0 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this 0 .
Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted
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granting of subdistributor rights in violation of this 0 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
Insurance. During the Term, Subdistributor shall, at its own expense, maintain and carry in full force and effect, subject to appropriate levels of self-insurance, all types and amounts of insurance required by applicable Law and all such insurance as is necessary to protect Distributor and its affiliates and their respective employees, officers and directors from and against any third party claims, including, without limitation, commercial general liability (including product liability) in a sum no less than $1,000,000 (per occurrence) and $2,000,000 (aggregate) with financially sound and reputable insurers. Upon Distributor’s request, Subdistributor shall provide Distributor with a certificate of insurance from Subdistributor’s insurer evidencing the insurance coverage specified in this Agreement. Subdistributor shall cause the certificate of insurance to name Distributor as an additional insured. Company shall provide Distributor with 30 days’ advance written notice in the event of a cancellation or material change in its insurance policy.
Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in connection with Subdistributor’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any audit shall be provided to Subdistributor in writing. Any audit will be conducted during regular business hours at Subdistributor’s business location.
Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in
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Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.7
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM Medical Consultants, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.7
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.7
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“Supplier” means the manufacturers and/or suppliers of the Product to Distributor.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.7
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.7
TERRITORY
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PRICING
|
1) |
Transfer pricing to be provided; |
|
2) |
During the length of this Agreement, If the Distributor provides billing services in behalf of the Sub-distributor due to the inability of the Sub-distributor to conduct business within a certain facility that the Distributor is able to, The Distributor will provide Sub-distributor with the following commission percentage(s); |
100% of Gross Profit after contracted transfer pricing deducted
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Exhibit 10.8
CPM MEDICAL CONSULTANTS, LLC
STOCKING AND SUBDISTRIBUTION AGREEMENT
THIS STOCKING AND SUBDISTRIBUTION AGREEMENT, dated as of [_______________, 20____] (the “ Agreement ”), is entered into by and between CPM Medical Consultants, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and [___________________________], a [______________] corporation having its principal place of business at _____________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor is in the business of distributing medical products and wishes to distribute the Products within the Territory; and
WHEREAS, Distributor wishes to engage Subdistributor to provide supplemental Product distribution on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Appointment
Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive subdistributor to Distributor of the Products in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
Excluded Customers . Notwithstanding 0 , Distributor does not appoint Subdistributor as its subdistributor of the Products for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in Product subdistribution activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer.
Status as Independent Contractor .
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party.
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The operations of Subdistributor are subject to the sole control of Subdistributor. Subdistributor is solely responsible for its Personnel and there are no joint employment relationships with Distributor regarding such Personnel by virtue of this Agreement. Without limitation of the foregoing, Subdistributor is solely responsible for, at its own expense: (i) providing such office space and facilities, and such Personnel (and their training) as may be necessary to carry out its obligations under this Agreement; (ii) compensating all Subdistributor Personnel for any services rendered in connection with the performance of its obligations under this Agreement; (iii) covering all Personnel under any applicable social benefit laws (including workers’ compensation and applicable state disability insurance) and obtaining any other customary insurance pertaining to Subdistributor’s operations and Personnel; and (iv) making any and all payroll deductions and contributions that may be required by Law or otherwise with respect to the Personnel. Subdistributor shall be solely responsible for any and all costs or expenses that it may incur in the performance of its obligations under this Agreement.
Reserved.
Subdistributor Obligations
Subdistribution .
Subdistributor shall perform the following during the Term:
Subdistributor . Subdistributor shall market, promote, and solicit orders for the Products as a subdistributor to Distributor to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in a manner consistent with Distributor’s Product marketing strategies and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor and its Suppliers;
Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a subdistributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal business hours with general support; and train Customers, including surgeons and hospital staff members, on the proper use of the Products;
Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory;
Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
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Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor or otherwise made available by Distributor’s Suppliers in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the respective policies of Distributor and its Suppliers applicable to Product distribution;;
Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
Recall Assistance . Subdistributor shall assist the Distributor and its Suppliers in effectuating any recall of the Products;
Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review matters pertaining to this Agreement as applicable;
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Product Delivery and Operating Room Support . Subdistributor shall be solely responsible for (i) scheduling the delivery of Products that it is distributing to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and (ii) providing case coverage and arranging for qualified and credentialed Subdistributor Personnel to be available and present in the operating room suite to provide the Products and applicable instrumentation associated with the Products and related Product technical support;
Litigation Support . Subdistributor shall render reasonable assistance to the Distributor and its Suppliers in the defense of any and all product liability claims;
Product Specialists . Subdistributor shall employ at least one Product specialist with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier;
Records and Audit . Subdistributor shall maintain records of its purchasing activities (including copies of the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker) and shall provide a copy of such records or otherwise make such records available to Distributor at Distributor’s request and election. Subdistributor shall also submit to Distributor, on a quarterly basis, a report containing detailed information, by Product, on Subdistributor’s customers, sales, and subdistribution activities in the preceding quarter, as well as a forecast of its approximate requirements for the Products for the subsequent four quarters. Distributor shall have the right to audit and inspect Subdistributor’s Product inventory and the records maintained by Subdistributor at any time and from time to time upon reasonable advance notice. Subdistributor agrees to fully cooperate with and assist Distributor in such inspections and audits; and
Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
Credentialing and Training .
To ensure Subdistributor is meeting the highest standards required by Distributor and its Suppliers, Subdistributor shall, during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the Supplier may provide from time to time relative to the Products. In addition, the Subdistributor shall be solely responsible for ensuring that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
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make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
generate any invoices on behalf of the Distributor for Products sold;
engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
Distributor Obligations
Distributor Obligations . During the Term, Distributor shall:
Shipment of Products and Instruments . Subject to Product availability and the terms and conditions of this Agreement, Distributor shall use reasonable efforts to fill Subdistributor’s orders for Products and Instruments, which are accepted by Distributor. It is understood by the Parties that expected delivery times will vary according to manufacturing and other conditions and that all delivery dates are estimates.
Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives and/or authorized subdistributors of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
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Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement to the extent such information and material is made available to Distributor by its Suppliers;
Samples . Distributor shall provide to Subdistributor samples and prototypes that are not intended for resale to the extent such are made available by its Suppliers and at the same cost (if any) assessed by its Suppliers. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in 0 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term; and
Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time.
Orders for Products and Instruments
Purchase Orders .
Subdistributor shall submit to Distributor written purchase orders for the Products and Instruments it elects to purchase and distribute pursuant to this Agreement, which orders shall include: (i) a list of the Products and Instruments ordered, (ii) the quantities of such Products and Instruments, and (iii) precise instructions for packaging, invoicing and shipping.
Consigned Inventory. Subdistributor may elect to order Product and Instrument stocking inventory on a consigned basis. Such orders for consigned inventory shall be subject to acceptance by Distributor and shall remain the property of Distributor until such time as the consigned inventory has been purchased.
Shipment Terms .
Subject to receipt and acceptance by Distributor of an order for purchase or consignment, unless otherwise agreed in writing, shipments, whether for purchased or consigned Product, shall be F.O.B. Distributor’s facility in Richardson, TX. Distributor shall not be obligated to make direct shipments to Subdistributor’s customers, unless otherwise agreed by the Parties. Distributor’s obligation to effect shipment of the Products and Instruments shall be fully discharged and all title (for purchased items) and risk of loss or damage (for all items) shall pass to Subdistributor when the Products and the Instruments are delivered to a carrier for shipment to Subdistributor. In addition, Subdistributor shall pay all charges, including, without limitation, all transportation charges and insurance premiums associated with the shipment and purchasing of the Products.
Modification or Cancellation of Orders .
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No accepted order shall be cancelled or modified except upon the written agreement of both Parties. Subdistributor’s orders or mutually agreed change orders shall be subject to all of the terms and conditions of this Agreement, whether or not the order or change order so states. In the event Subdistributor cancels an order after such order has been accepted by Distributor, Subdistributor shall reimburse Distributor for all costs incurred as a result of such order.
Product and Policy Changes .
Distributor reserves the right from time to time and in its discretion, without incurring any liability to Subdistributor: (i) to discontinue or limit its distribution of any Product; (ii) to allocate or to terminate or limit deliveries of any Product; (iii) to alter the design or construction of any Product or Instrument; (iv) to add new and additional Products; and (v) upon reasonable notice to Subdistributor, change its sales and purchasing policies to the extent that such changes are not inconsistent with the terms of this Agreement.
No Shipment Obligation .
Distributor shall not be obligated to make any shipment if such shipment could, at the time thereof, constitute a violation of any laws, regulations or policies.
Acceptance of Products and Instruments .
Subdistributor shall conduct any incoming inspections or acceptance tests as soon as possible upon arrival of the Products or Instruments at the shipping address, but in no event later than ten (10) days from the date of receipt. Any Products or Instruments not rejected by Subdistributor by written notice to Distributor within such period shall be deemed accepted. Subdistributor shall promptly report to Distributor any shortage, damage, or discrepancy in or to a shipment of Products or Instruments discovered by Subdistributor during such ten (10) day acceptance period and furnish written evidence or other documentation that Distributor deems appropriate. If the substantiating evidence delivered by Subdistributor demonstrates to Distributor’s satisfaction that such shortage, damage or discrepancy existed at the time of delivery of the Products or Instruments to the carrier, Distributor shall, at its discretion, promptly deliver additional or substitute Products or Instruments to Subdistributor at Distributor’s expense or issue a credit to Subdistributor.
Product Return .
Except as provided in this Section, Subdistributor may not return any Product to Distributor for any reason without Distributor’s prior written consent. Further, the following shall apply: (a) Sterile merchandise, which has been opened, has a breach of the package integrity, or has otherwise been damaged, will not be credited upon return; (b) special order or custom items will not be credited upon return; (c) obsolete merchandise not listed in Distributor’s then-current Product catalogs cannot be returned; and (d) items with an expired shelf life or sterile expiration date cannot be returned.
Price and Payment
Price. Subdistributor shall pay for the Products and the Instruments purchased under this Agreement at the prices set forth on Distributor’s then current price list. All prices include packing in accordance with Distributor’s standard practices in effect at the time of shipment. Special packing or handling shall be at
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the sole expense of Subdistributor.
Price Changes. Pricing for all Products shall remain in effect during the term of this Agreement unless mutually agreed upon in writing by both Distributor and Subdistributor. In the event that Distributor reduces the price of the Products or the Instruments ordered by Subdistributor, Distributor may, in its sole discretion and upon Subdistributor’s written request within thirty (30) days of each shipment, issue a credit to Subdistributor in the amount of the price reduction applicable to that shipment.
Payment. Subdistributor shall pay for the Products and the Instruments within thirty (30) days of receipt of invoice for said Products or Instruments.
Taxes . Subdistributor is responsible for and shall pay or reimburse Distributor for all taxes (except Distributor’s net income taxes), duties, assessments and other governmental charges, however designated, associated with the purchase and purchasing of Products and the performance of this Agreement.
Subdistributor Warranties . Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; (f) when executed and delivered by each of Distributor and Subdistributor, this Agreement will constitute the legal, valid, and binding obligation of Subdistributor, enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity); (g) Subdistributor shall conduct its activities and perform its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such laws, rules or regulations, and bear all of its costs and expenses in connection therewith; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time.
No Inconsistent Warranties . Subdistributor shall not make any claims or representations concerning the Products that are inconsistent with those made by Distributor or its Suppliers.
Supplier Warranties . The warranties made by Supplier with respect to each Product are solely those that are contained in the product insert accompanying such Product. No other affirmation of fact or promise made by Distributor or its Suppliers, whether or not in this Agreement, by words
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or action shall constitute a warranty. The foregoing warranty does not extend to any Product that is modified or altered, or treated with abuse, negligence or other improper treatment.
Standard Limited Warranty. Distributor shall pass on to Subdistributor so that it may pass on to the customers the Supplier's standard limited warranty for Products, including limitations set for in subsection (b) Limitation of Liability and Warranty below. Except for the stated warranty set forth on, or included with, the Products as delivered to the Subdistributor and /or its customers, the warranty and remedy set forth in this 0 are exclusive and all other warranties, guarantees or representations, express or implied, by Distributor’s Suppliers with respect to the applicable Products, including, without limitation, warranties of merchantability and fitness for particular purpose, and any other obligation or liability of Distributor and its Suppliers to Subdistributor or to any third party with respect to the Products, are hereby excluded. This warranty is contingent upon proper use of a Product in the application for which such Product was intended and does not cover Products that were modified without Distributor or its Supplier’s prior written approval, that have expired or that were subjected to physical, chemical or electrical stress that the products were not originally designed for.
Limitation of Liability and Warranty. Distributor and its Suppliers’ liability arising out of this agreement and/or sale of the products shall be limited as follows: in no event shall Distributor and its Suppliers be liable for costs of the procurement of substitute goods by anyone. In no event shall Distributor and its Suppliers be liable to Subdistributor or any other entity for any special, consequential, incidental, or indirect damages, however caused, on any theory of liability or breach of warranty, whether or not Distributor and its Suppliers have been advised on the possibility. Except for the express limited warranty set forth in previous subsection (a) Standard Limited Warranty above, Distributor and its Suppliers grant no implied warranties for the Products, either in fact or by operation of law, by statute, or otherwise.
Warranty Disclaimer . EXCEPT AS EXPRESSLY PROVIDED HEREIN, DISTRIBUTOR AND ITS SUPPLIERS MAKE NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD, CONSIGNED OR LOANED OR OTHERWISE DISTRIBUTED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
IP Rights
Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).
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Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor and in accordance with the Supplier guidelines relative to such Product marketing. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to 0 or 0 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
Distributor’s Right to Terminate . Distributor may terminate this Agreement by providing written notice to Subdistributor:
at any time for its convenience upon thirty (30) days prior written notice;
if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee,
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receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; or (b) if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
Effect of Expiration or Termination .
Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to 0 and (ii) were incurred by the Parties prior to such expiration or earlier termination.
Upon the expiration or earlier termination of this Agreement, and subject to Distributor elections set forth in subsection (c) below, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized subdistributor with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) make arrangements with Distributor relative to the handling and return of any consigned Products or Instruments; (iii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iv) to the extent legally permissible to do so, permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (v) certify in writing to Distributor that it has complied with the requirements of this 0. In the event (i) Subdistributor does not immediately return all such consigned Products and Instruments, or (ii) Distributor, in its discretion, determines that the consigned Products and Instruments that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Products and Instrument price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any consigned Products or Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon return and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subject to all of the terms and conditions of this Agreement, upon any termination or expiration of this Agreement for any reason whatsoever, Subdistributor shall retain the non-exclusive right to distribute the remaining Products that it purchased and remain in its inventory on the date of termination for 12 months (and all of the terms and conditions of this Agreement shall continue to apply during such 12 month period), unless Distributor exercises the option in the following sentence. Distributor shall have the option at any time after expiration or termination of this Agreement to immediately terminate Subdistributor’s rights to distribute its purchased inventory by repurchasing Subdistributor’s purchased inventory of Products at the
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price Subdistributor paid for that inventory and payment of Distributor’s then-current restocking fees applicable to such Products. Notwithstanding the foregoing, in no event shall Distributor have any obligation to repurchase Subdistributor’s purchased inventory.
Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
is or becomes generally available to the public other than as a result of any direct or indirect breach of this 0 by Subdistributor or any of its Representatives;
is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
is required to be disclosed pursuant to applicable Law.
Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this 0 caused by any of its Representatives.
Regulatory Matters
Medical Device Reporting Requirements . Subdistributor shall provide such assistance and information as Distributor and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor shall: (1) immediately
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transmit to Distributor all oral or written complaints regarding the Products that are received by Subdistributor; (2) keep and maintain a record of all customer complaints received by Subdistributor relating to the Products that are required to be maintained by Subdistributor pursuant to 21 C.F.R. § 803.18; (3) notify Distributor upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor and its Suppliers. It is the sole responsibility of Distributor and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territory. Notwithstanding the foregoing, in the event that Subdistributor is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor from doing so; provided, however, that Subdistributor shall immediately provide Distributor with prior notice of such reporting (to the extent legally permissible) and provide Distributor with copies of any such filings or reports (to the extent legally permissible).
Compliance with U.S. Food and Drug Administration Recall Policy . In order to assure compliance with FDA Recall policies, the Subdistributor will provide Distributor with a record of each surgery in which Distributor’s Suppliers’ respective Products sold to Subdistributor have been implanted. Distributor and Subdistributor will fully comply with all requirements of HIPAA including safeguarding the names and medical records of patients. The information required to be reported to Distributor by Subdistributor will be the Hospital Proof of Delivery form or a Charge Sheet from the Subdistributor which must include the date of surgery, the name of the hospital in which the surgery was performed, the name of the surgeon performing the surgery and a list of products implanted by unit catalog number, lot number and sterility expiration date. The first name and first initial of the patient’s last name will also be included, but the full name of the patient will be retained by Subdistributor and immediately reported to Distributor in the event of an actual recall of the implanted products. Failure of the Subdistributor to provide this information may cause Distributor to delay shipment of replacement / restock products to Subdistributor until such information has been provided.
Governmental Inspections and Inquiries . Subdistributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor in writing of, and shall provide Distributor with copies of, any correspondence and other documentation received or prepared by the Subdistributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority:
Receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the storage, marketing, advertisement, sale and/or purchasing of the Product(s); and
Any Governmental or Regulatory Authority’s comments relating to the Product(s) that may require a response or action by Distributor.
Without limiting the generality of the foregoing, in the event that the Subdistributor or any of its Representatives receive a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Product(s) that requires a response or action by Distributor and/or its Suppliers, the Subdistributor shall promptly provide to Distributor any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing of the Product(s), and the Subdistributor will cooperate fully with Distributor in preparing such response.
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In the event any facility that is used by the Subdistributor or any of its Representatives to store, market advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor shall notify the Distributor promptly upon learning of such inspection and shall supply Distributor with copies of any correspondence that relates to such inspection. Distributor may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Product(s). The Subdistributor shall (to the extent legally permissible) furnish to Distributor copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with five (5) business days after the delivery of such information by the Governmental or Regulatory Authority.
The Distributor shall, at its discretion and to the extent legally permissible, provide Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority.
In the event any Governmental Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.
Complaints . Subdistributor shall cooperate fully with Distributor and its Suppliers in dealing with any complaints concerning the Products.
Tracking . Subdistributor shall track the Products in accordance with all applicable laws and regulations.
Removals and Corrections (Recalls) . Subdistributor shall provide such assistance and information as Distributor reasonably requests in the event that Distributor and/or its Suppliers determine that a removal, correction, recall or other field action involving the Products is warranted. Without limiting the generality of the foregoing, Subdistributor shall retain, for a period of five years (or such other period as required by applicable law) after termination of this Agreement, records of all Product sales and customers sufficient to adequately administer a recall or similar action involving the Products.
Indemnification . Subject to the terms and conditions set forth in 0 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily
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injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
Non-Solicitation and Non-Circumvention
During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this 0 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this 0.
Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other purpose except solely for the benefit of and as directed by Distributor.
Limitation of Liability
NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT
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OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO DISTRIBUTOR BY SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT DURING THE TWELVE MONTH PERIOD PRIOR TO THE DATE THE CAUSE OF ACTION AROSE, REGARDLESS OF WHETHER DISTRIBUTOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Miscellaneous
Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all notices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of 0 , 0 , 0 , notice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this 0 . Except as otherwise provided in this Agreement, a notice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the notice has complied with the requirements of this 0 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: Bill McLaughlin, CFO
Attn: [_____________________]
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
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CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn:
Contracts ManagerAttn: [_____________________]
E-mail:
Kmcdonald@surgicalservice.comE-mail: [___________________]
Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement between the Parties, or otherwise.
Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under 0 or 0 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this 0 .
Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted
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granting of subdistributor rights in violation of this 0 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
Insurance. During the Term, Subdistributor shall, at its own expense, maintain and carry in full force and effect, subject to appropriate levels of self-insurance, all types and amounts of insurance required by applicable Law and all such insurance as is necessary to protect Distributor and its affiliates and their respective employees, officers and directors from and against any third party claims, including, without limitation, commercial general liability (including product liability) in a sum no less than $1,000,000 (per occurrence) and $2,000,000 (aggregate) with financially sound and reputable insurers. Upon Distributor’s request, Subdistributor shall provide Distributor with a certificate of insurance from Subdistributor’s insurer evidencing the insurance coverage specified in this Agreement. Subdistributor shall cause the certificate of insurance to name Distributor as an additional insured. Company shall provide Distributor with 30 days’ advance written notice in the event of a cancellation or material change in its insurance policy.
Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in connection with Subdistributor’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any audit shall be provided to Subdistributor in writing. Any audit will be conducted during regular business hours at Subdistributor’s business location.
Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in
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Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.8
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM Medical Consultants, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.8
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.8
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“Supplier” means the manufacturers and/or suppliers of the Product to Distributor.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.8
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.8
TERRITORY
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PRICING
|
1) |
Transfer pricing to be provided; |
|
2) |
During the length of this Agreement, If the Distributor provides billing services in behalf of the Sub-distributor due to the inability of the Sub-distributor to conduct business within a certain facility that the Distributor is able to, The Distributor will provide Sub-distributor with the following commission percentage(s); |
100% of Gross Profit after contracted transfer pricing deducted
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Exhibit 10.9
CPM MEDICAL CONSULTANTS, LLC
STOCKING AND SUBDISTRIBUTION AGREEMENT
THIS STOCKING AND SUBDISTRIBUTION AGREEMENT, dated as of [_______________, 20____] (the “ Agreement ”), is entered into by and between CPM Medical Consultants, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and [___________________________], a [______________] corporation having its principal place of business at _____________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor is in the business of distributing medical products and wishes to distribute the Products within the Territory; and
WHEREAS, Distributor wishes to engage Subdistributor to provide supplemental Product distribution on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Appointment
Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive subdistributor to Distributor of the Products in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
Excluded Customers . Notwithstanding 0 , Distributor does not appoint Subdistributor as its subdistributor of the Products for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in Product subdistribution activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer.
Status as Independent Contractor .
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party.
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The operations of Subdistributor are subject to the sole control of Subdistributor. Subdistributor is solely responsible for its Personnel and there are no joint employment relationships with Distributor regarding such Personnel by virtue of this Agreement. Without limitation of the foregoing, Subdistributor is solely responsible for, at its own expense: (i) providing such office space and facilities, and such Personnel (and their training) as may be necessary to carry out its obligations under this Agreement; (ii) compensating all Subdistributor Personnel for any services rendered in connection with the performance of its obligations under this Agreement; (iii) covering all Personnel under any applicable social benefit laws (including workers’ compensation and applicable state disability insurance) and obtaining any other customary insurance pertaining to Subdistributor’s operations and Personnel; and (iv) making any and all payroll deductions and contributions that may be required by Law or otherwise with respect to the Personnel. Subdistributor shall be solely responsible for any and all costs or expenses that it may incur in the performance of its obligations under this Agreement.
Reserved.
Subdistributor Obligations
Subdistribution .
Subdistributor shall perform the following during the Term:
Subdistributor . Subdistributor shall market, promote, and solicit orders for the Products as a subdistributor to Distributor to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in a manner consistent with Distributor’s Product marketing strategies and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor and its Suppliers;
Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a subdistributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal business hours with general support; and train Customers, including surgeons and hospital staff members, on the proper use of the Products;
Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory;
Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
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Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor or otherwise made available by Distributor’s Suppliers in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the respective policies of Distributor and its Suppliers applicable to Product distribution;;
Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
Recall Assistance . Subdistributor shall assist the Distributor and its Suppliers in effectuating any recall of the Products;
Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review matters pertaining to this Agreement as applicable;
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Product Delivery and Operating Room Support . Subdistributor shall be solely responsible for (i) scheduling the delivery of Products that it is distributing to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and (ii) providing case coverage and arranging for qualified and credentialed Subdistributor Personnel to be available and present in the operating room suite to provide the Products and applicable instrumentation associated with the Products and related Product technical support;
Litigation Support . Subdistributor shall render reasonable assistance to the Distributor and its Suppliers in the defense of any and all product liability claims;
Product Specialists . Subdistributor shall employ at least one Product specialist with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier;
Records and Audit . Subdistributor shall maintain records of its purchasing activities (including copies of the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker) and shall provide a copy of such records or otherwise make such records available to Distributor at Distributor’s request and election. Subdistributor shall also submit to Distributor, on a quarterly basis, a report containing detailed information, by Product, on Subdistributor’s customers, sales, and subdistribution activities in the preceding quarter, as well as a forecast of its approximate requirements for the Products for the subsequent four quarters. Distributor shall have the right to audit and inspect Subdistributor’s Product inventory and the records maintained by Subdistributor at any time and from time to time upon reasonable advance notice. Subdistributor agrees to fully cooperate with and assist Distributor in such inspections and audits; and
Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
Credentialing and Training .
To ensure Subdistributor is meeting the highest standards required by Distributor and its Suppliers, Subdistributor shall, during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the Supplier may provide from time to time relative to the Products. In addition, the Subdistributor shall be solely responsible for ensuring that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
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make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
generate any invoices on behalf of the Distributor for Products sold;
engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
Distributor Obligations
Distributor Obligations . During the Term, Distributor shall:
Shipment of Products and Instruments . Subject to Product availability and the terms and conditions of this Agreement, Distributor shall use reasonable efforts to fill Subdistributor’s orders for Products and Instruments, which are accepted by Distributor. It is understood by the Parties that expected delivery times will vary according to manufacturing and other conditions and that all delivery dates are estimates.
Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives and/or authorized subdistributors of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
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Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement to the extent such information and material is made available to Distributor by its Suppliers;
Samples . Distributor shall provide to Subdistributor samples and prototypes that are not intended for resale to the extent such are made available by its Suppliers and at the same cost (if any) assessed by its Suppliers. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in 0 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term; and
Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time.
Orders for Products and Instruments
Purchase Orders .
Subdistributor shall submit to Distributor written purchase orders for the Products and Instruments it elects to purchase and distribute pursuant to this Agreement, which orders shall include: (i) a list of the Products and Instruments ordered, (ii) the quantities of such Products and Instruments, and (iii) precise instructions for packaging, invoicing and shipping.
Consigned Inventory. Subdistributor may elect to order Product and Instrument stocking inventory on a consigned basis. Such orders for consigned inventory shall be subject to acceptance by Distributor and shall remain the property of Distributor until such time as the consigned inventory has been purchased.
Shipment Terms .
Subject to receipt and acceptance by Distributor of an order for purchase or consignment, unless otherwise agreed in writing, shipments, whether for purchased or consigned Product, shall be F.O.B. Distributor’s facility in Richardson, TX. Distributor shall not be obligated to make direct shipments to Subdistributor’s customers, unless otherwise agreed by the Parties. Distributor’s obligation to effect shipment of the Products and Instruments shall be fully discharged and all title (for purchased items) and risk of loss or damage (for all items) shall pass to Subdistributor when the Products and the Instruments are delivered to a carrier for shipment to Subdistributor. In addition, Subdistributor shall pay all charges, including, without limitation, all transportation charges and insurance premiums associated with the shipment and purchasing of the Products.
Modification or Cancellation of Orders .
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No accepted order shall be cancelled or modified except upon the written agreement of both Parties. Subdistributor’s orders or mutually agreed change orders shall be subject to all of the terms and conditions of this Agreement, whether or not the order or change order so states. In the event Subdistributor cancels an order after such order has been accepted by Distributor, Subdistributor shall reimburse Distributor for all costs incurred as a result of such order.
Product and Policy Changes .
Distributor reserves the right from time to time and in its discretion, without incurring any liability to Subdistributor: (i) to discontinue or limit its distribution of any Product; (ii) to allocate or to terminate or limit deliveries of any Product; (iii) to alter the design or construction of any Product or Instrument; (iv) to add new and additional Products; and (v) upon reasonable notice to Subdistributor, change its sales and purchasing policies to the extent that such changes are not inconsistent with the terms of this Agreement.
No Shipment Obligation .
Distributor shall not be obligated to make any shipment if such shipment could, at the time thereof, constitute a violation of any laws, regulations or policies.
Acceptance of Products and Instruments .
Subdistributor shall conduct any incoming inspections or acceptance tests as soon as possible upon arrival of the Products or Instruments at the shipping address, but in no event later than ten (10) days from the date of receipt. Any Products or Instruments not rejected by Subdistributor by written notice to Distributor within such period shall be deemed accepted. Subdistributor shall promptly report to Distributor any shortage, damage, or discrepancy in or to a shipment of Products or Instruments discovered by Subdistributor during such ten (10) day acceptance period and furnish written evidence or other documentation that Distributor deems appropriate. If the substantiating evidence delivered by Subdistributor demonstrates to Distributor’s satisfaction that such shortage, damage or discrepancy existed at the time of delivery of the Products or Instruments to the carrier, Distributor shall, at its discretion, promptly deliver additional or substitute Products or Instruments to Subdistributor at Distributor’s expense or issue a credit to Subdistributor.
Product Return .
Except as provided in this Section, Subdistributor may not return any Product to Distributor for any reason without Distributor’s prior written consent. Further, the following shall apply: (a) Sterile merchandise, which has been opened, has a breach of the package integrity, or has otherwise been damaged, will not be credited upon return; (b) special order or custom items will not be credited upon return; (c) obsolete merchandise not listed in Distributor’s then-current Product catalogs cannot be returned; and (d) items with an expired shelf life or sterile expiration date cannot be returned.
Price and Payment
Price. Subdistributor shall pay for the Products and the Instruments purchased under this Agreement at the prices set forth on Distributor’s then current price list. All prices include packing in accordance with Distributor’s standard practices in effect at the time of shipment. Special packing or handling shall be at
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the sole expense of Subdistributor.
Price Changes. Pricing for all Products shall remain in effect during the term of this Agreement unless mutually agreed upon in writing by both Distributor and Subdistributor. In the event that Distributor reduces the price of the Products or the Instruments ordered by Subdistributor, Distributor may, in its sole discretion and upon Subdistributor’s written request within thirty (30) days of each shipment, issue a credit to Subdistributor in the amount of the price reduction applicable to that shipment.
Payment. Subdistributor shall pay for the Products and the Instruments within thirty (30) days of receipt of invoice for said Products or Instruments.
Taxes . Subdistributor is responsible for and shall pay or reimburse Distributor for all taxes (except Distributor’s net income taxes), duties, assessments and other governmental charges, however designated, associated with the purchase and purchasing of Products and the performance of this Agreement.
Subdistributor Warranties . Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; (f) when executed and delivered by each of Distributor and Subdistributor, this Agreement will constitute the legal, valid, and binding obligation of Subdistributor, enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity); (g) Subdistributor shall conduct its activities and perform its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such laws, rules or regulations, and bear all of its costs and expenses in connection therewith; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time.
No Inconsistent Warranties . Subdistributor shall not make any claims or representations concerning the Products that are inconsistent with those made by Distributor or its Suppliers.
Supplier Warranties . The warranties made by Supplier with respect to each Product are solely those that are contained in the product insert accompanying such Product. No other affirmation of fact or promise made by Distributor or its Suppliers, whether or not in this Agreement, by words
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or action shall constitute a warranty. The foregoing warranty does not extend to any Product that is modified or altered, or treated with abuse, negligence or other improper treatment.
Standard Limited Warranty. Distributor shall pass on to Subdistributor so that it may pass on to the customers the Supplier's standard limited warranty for Products, including limitations set for in subsection (b) Limitation of Liability and Warranty below. Except for the stated warranty set forth on, or included with, the Products as delivered to the Subdistributor and /or its customers, the warranty and remedy set forth in this 0 are exclusive and all other warranties, guarantees or representations, express or implied, by Distributor’s Suppliers with respect to the applicable Products, including, without limitation, warranties of merchantability and fitness for particular purpose, and any other obligation or liability of Distributor and its Suppliers to Subdistributor or to any third party with respect to the Products, are hereby excluded. This warranty is contingent upon proper use of a Product in the application for which such Product was intended and does not cover Products that were modified without Distributor or its Supplier’s prior written approval, that have expired or that were subjected to physical, chemical or electrical stress that the products were not originally designed for.
Limitation of Liability and Warranty. Distributor and its Suppliers’ liability arising out of this agreement and/or sale of the products shall be limited as follows: in no event shall Distributor and its Suppliers be liable for costs of the procurement of substitute goods by anyone. In no event shall Distributor and its Suppliers be liable to Subdistributor or any other entity for any special, consequential, incidental, or indirect damages, however caused, on any theory of liability or breach of warranty, whether or not Distributor and its Suppliers have been advised on the possibility. Except for the express limited warranty set forth in previous subsection (a) Standard Limited Warranty above, Distributor and its Suppliers grant no implied warranties for the Products, either in fact or by operation of law, by statute, or otherwise.
Warranty Disclaimer . EXCEPT AS EXPRESSLY PROVIDED HEREIN, DISTRIBUTOR AND ITS SUPPLIERS MAKE NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD, CONSIGNED OR LOANED OR OTHERWISE DISTRIBUTED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
IP Rights
Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).
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Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor and in accordance with the Supplier guidelines relative to such Product marketing. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to 0 or 0 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
Distributor’s Right to Terminate . Distributor may terminate this Agreement by providing written notice to Subdistributor:
at any time for its convenience upon thirty (30) days prior written notice;
if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee,
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receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; or (b) if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
Effect of Expiration or Termination .
Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to 0 and (ii) were incurred by the Parties prior to such expiration or earlier termination.
Upon the expiration or earlier termination of this Agreement, and subject to Distributor elections set forth in subsection (c) below, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized subdistributor with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) make arrangements with Distributor relative to the handling and return of any consigned Products or Instruments; (iii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iv) to the extent legally permissible to do so, permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (v) certify in writing to Distributor that it has complied with the requirements of this 0. In the event (i) Subdistributor does not immediately return all such consigned Products and Instruments, or (ii) Distributor, in its discretion, determines that the consigned Products and Instruments that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Products and Instrument price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor (if any). Further, any consigned Products or Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon return and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor (if any).
Subject to all of the terms and conditions of this Agreement, upon any termination or expiration of this Agreement for any reason whatsoever, Subdistributor shall retain the non-exclusive right to distribute the remaining Products that it purchased and remain in its inventory on the date of termination for 12 months (and all of the terms and conditions of this Agreement shall continue to apply during such 12 month period), unless Distributor exercises the option in the following sentence. Distributor shall have the option at any time after expiration or termination of this Agreement to immediately terminate Subdistributor’s rights to distribute its purchased inventory by repurchasing Subdistributor’s purchased inventory of Products at the
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price Subdistributor paid for that inventory and payment of Distributor’s then-current restocking fees applicable to such Products. Notwithstanding the foregoing, in no event shall Distributor have any obligation to repurchase Subdistributor’s purchased inventory.
Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
is or becomes generally available to the public other than as a result of any direct or indirect breach of this 0 by Subdistributor or any of its Representatives;
is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
is required to be disclosed pursuant to applicable Law.
Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this 0 caused by any of its Representatives.
Regulatory Matters
Medical Device Reporting Requirements . Subdistributor shall provide such assistance and information as Distributor and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor shall: (1) immediately
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transmit to Distributor all oral or written complaints regarding the Products that are received by Subdistributor; (2) keep and maintain a record of all customer complaints received by Subdistributor relating to the Products that are required to be maintained by Subdistributor pursuant to 21 C.F.R. § 803.18; (3) notify Distributor upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor and its Suppliers. It is the sole responsibility of Distributor and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territory. Notwithstanding the foregoing, in the event that Subdistributor is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor from doing so; provided, however, that Subdistributor shall immediately provide Distributor with prior notice of such reporting (to the extent legally permissible) and provide Distributor with copies of any such filings or reports (to the extent legally permissible).
Compliance with U.S. Food and Drug Administration Recall Policy . In order to assure compliance with FDA Recall policies, the Subdistributor will provide Distributor with a record of each surgery in which Distributor’s Suppliers’ respective Products sold to Subdistributor have been implanted. Distributor and Subdistributor will fully comply with all requirements of HIPAA including safeguarding the names and medical records of patients. The information required to be reported to Distributor by Subdistributor will be the Hospital Proof of Delivery form or a Charge Sheet from the Subdistributor which must include the date of surgery, the name of the hospital in which the surgery was performed, the name of the surgeon performing the surgery and a list of products implanted by unit catalog number, lot number and sterility expiration date. The first name and first initial of the patient’s last name will also be included, but the full name of the patient will be retained by Subdistributor and immediately reported to Distributor in the event of an actual recall of the implanted products. Failure of the Subdistributor to provide this information may cause Distributor to delay shipment of replacement / restock products to Subdistributor until such information has been provided.
Governmental Inspections and Inquiries . Subdistributor shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Distributor in writing of, and shall provide Distributor with copies of, any correspondence and other documentation received or prepared by the Subdistributor in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority:
Receipt of a regulatory letter (such as a Warning Letter or untitled letter), warning, recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the storage, marketing, advertisement, sale and/or purchasing of the Product(s); and
Any Governmental or Regulatory Authority’s comments relating to the Product(s) that may require a response or action by Distributor.
Without limiting the generality of the foregoing, in the event that the Subdistributor or any of its Representatives receive a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Product(s) that requires a response or action by Distributor and/or its Suppliers, the Subdistributor shall promptly provide to Distributor any data or information required in preparing such response that relates to storage, marketing, advertising, sale or purchasing of the Product(s), and the Subdistributor will cooperate fully with Distributor in preparing such response.
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In the event any facility that is used by the Subdistributor or any of its Representatives to store, market advertise, distribute or sell any of the Product(s) is inspected by representatives of any Governmental or Regulatory Authority, the Subdistributor shall notify the Distributor promptly upon learning of such inspection and shall supply Distributor with copies of any correspondence that relates to such inspection. Distributor may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Product(s). The Subdistributor shall (to the extent legally permissible) furnish to Distributor copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses with five (5) business days after the delivery of such information by the Governmental or Regulatory Authority.
The Distributor shall, at its discretion and to the extent legally permissible, provide Subdistributor with a copy of any response related to such visit or inspection for Subdistributor’s review and comment prior to submission of the response. The Distributor, at its discretion and to the extent legally permissible, shall provide Subdistributor with a copy of the final response promptly after it is submitted to the Governmental of Regulatory Authority.
In the event any Governmental Authority detains or seizes any of the Product(s) from the Subdistributor or any of its Representatives, the Subdistributor shall, to the extent legally permissible, promptly send retained samples of each applicable Product and duplicate reports relating to such seizure to Distributor.
Complaints . Subdistributor shall cooperate fully with Distributor and its Suppliers in dealing with any complaints concerning the Products.
Tracking . Subdistributor shall track the Products in accordance with all applicable laws and regulations.
Removals and Corrections (Recalls) . Subdistributor shall provide such assistance and information as Distributor reasonably requests in the event that Distributor and/or its Suppliers determine that a removal, correction, recall or other field action involving the Products is warranted. Without limiting the generality of the foregoing, Subdistributor shall retain, for a period of five years (or such other period as required by applicable law) after termination of this Agreement, records of all Product sales and customers sufficient to adequately administer a recall or similar action involving the Products.
Indemnification . Subject to the terms and conditions set forth in 0 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily
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injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
Non-Solicitation and Non-Circumvention
During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this 0 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this 0.
Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other purpose except solely for the benefit of and as directed by Distributor.
Limitation of Liability
NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF 0, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT
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OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO DISTRIBUTOR BY SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT DURING THE TWELVE MONTH PERIOD PRIOR TO THE DATE THE CAUSE OF ACTION AROSE, REGARDLESS OF WHETHER DISTRIBUTOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Miscellaneous
Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all notices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of 0 , 0 , 0 , notice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this 0 . Except as otherwise provided in this Agreement, a notice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the notice has complied with the requirements of this 0 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: Bill McLaughlin, CFO
Attn: [_____________________]
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
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CPM Medical Consultants, LLC
[__________________________]
1565 N. Central Expressway, Suite 200
[__________________________]
Richardson, TX 75080
[__________________________]
Attn:
Contracts ManagerAttn: [_____________________]
E-mail:
Kmcdonald@surgicalservice.comE-mail: [___________________]
Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement between the Parties, or otherwise.
Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under 0 or 0 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this 0 .
Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted
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granting of subdistributor rights in violation of this 0 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
Insurance. During the Term, Subdistributor shall, at its own expense, maintain and carry in full force and effect, subject to appropriate levels of self-insurance, all types and amounts of insurance required by applicable Law and all such insurance as is necessary to protect Distributor and its affiliates and their respective employees, officers and directors from and against any third party claims, including, without limitation, commercial general liability (including product liability) in a sum no less than $1,000,000 (per occurrence) and $2,000,000 (aggregate) with financially sound and reputable insurers. Upon Distributor’s request, Subdistributor shall provide Distributor with a certificate of insurance from Subdistributor’s insurer evidencing the insurance coverage specified in this Agreement. Subdistributor shall cause the certificate of insurance to name Distributor as an additional insured. Company shall provide Distributor with 30 days’ advance written notice in the event of a cancellation or material change in its insurance policy.
Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in connection with Subdistributor’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any audit shall be provided to Subdistributor in writing. Any audit will be conducted during regular business hours at Subdistributor’s business location.
Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in
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Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.9
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM Medical Consultants, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.9
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.9
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“Supplier” means the manufacturers and/or suppliers of the Product to Distributor.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.9
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.9
TERRITORY
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PRICING
|
1) |
Transfer pricing to be provided; |
|
2) |
During the length of this Agreement, If the Distributor provides billing services in behalf of the Sub-distributor due to the inability of the Sub-distributor to conduct business within a certain facility that the Distributor is able to, The Distributor will provide Sub-distributor with the following commission percentage(s); |
100% of Gross Profit after contracted transfer pricing deducted
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Exhibit 10.10
CPM MEDICAL CONSULTANTS, LLC
SALES AND DISTRIBUTION SERVICES AGREEMENT
THIS SALE AND DISTRIBUTION SERVICES AGREEMENT, dated as of March 1 st , 2018 (the “ Agreement ”), is entered into by and between CPM MEDICAL CONSULTANTS, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and _________________ ,a Texas corporation having its principal place of business at __________________________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor provides marketing, distribution and sales support services and wishes to provide Distributor with such support services; and
WHEREAS, Distributor wishes to engage Subdistributor to support its Product marketing, distribution and sales efforts on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1
Appointment
SECTION 1.1 Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive provider of the Services to Distributor in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
SECTION 1.2 Excluded Customers . Notwithstanding SECTION 1.1 , Distributor does not appoint Subdistributor as its provider of the Services for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in sales and marketing activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer. Subdistributor acknowledges and agrees that it is not entitled to any Compensation for any sale made to an Excluded Customer.
SECTION 1.3 Status as Independent Contractor .
|
(a) |
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party. |
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|
(c) |
The Distributor, to the extent applicable, shall issue Subdistributor a Form 1099 for all payments made hereunder. All taxes, withholding and the like on any and all amounts paid under this Agreement shall be solely, and absolutely the Subdistributor’s responsibility. The Subdistributor agrees that it shall indemnify, defend and hold the Distributor and its employees, affiliates, and sales representatives, harmless from and against any judgments, fines, costs or fees associated with such payments hereunder. |
ARTICLE 2
Subdistributor Obligations
SECTION 2.1 |
Services . |
Subdistributor shall perform the following Services during the Term:
(a) Sales and Marketing . Subdistributor shall market, promote, and solicit orders for the Products to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in accordance with Distributor’s Product marketing strategies, channel and pricing guidelines, and sales policies, and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor;
(b) Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a Service provider of the Distributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
(c) Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal
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business hours with general support; and assist the Distributor in training Customers, including surgeons and hospital staff members, on the proper use of the Products ;
(d) Customer Meetings . Subdistributor shall initiate and attend sales calls and meetings with prospective and existing Customers;
(e) Sales and Marketing Plan . Subdistributor shall develop and execute a sales and marketing plan in support of Distributor’s marketing strategy that will include, without limitation, identifying sales opportunities to Distributor within the Territory, and provide support to the Distributor’s contract department on an as needed basis;
(f) Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory. Subdistributor shall receive no compensation with respect to any such inquiries or orders;
(g) Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
(h) Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the Subdistributor policies applicable to Product sales, marketing, customer support, and Product pricing;
(i) Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor in accordance with Section 5.3 below. Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor.
(j) Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
(k) Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address
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and investigate, any c omplaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
(l) Recall Assistance . Subdistributor shall assist the Distributor in effectuating any recall of the Products;
(m) Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
(n) Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
(o) Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review Subdistributor’s performance, Subdistributor’s compliance with Distributor’s Code of Conduct, and other matters pertaining to this Agreement as applicable;
(p) Product Delivery and Operating Room Support . Subdistributor shall schedule the delivery of the Products to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and provide case coverage and arrange for qualified and credentialed Subdistributor Personnel are available and present in the operating room suite to provide the Products and instrumentation associated with the Products and related technical support;
(q) Charge Sheet and Purchase Orders . Subdistributor shall obtain the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker; and obtain the applicable purchase order from the hospital or clinic purchasing or procurement representative;
(r) Litigation Support . Subdistributor shall render reasonable assistance to the Distributor in the defense of any and all product liability claims;
(s) Product Specialists . Subdistributor shall employ at least one Product specialist, acceptable to Distributor, with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
(t) Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier; and
(u) Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
SECTION 2.2 Credentialing and Training .
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To ensure Subdistributor is meeting the highest standards required by Distributor , Subdistributor shall , during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the manufacturer may provide from time to time relative to the Products. In addition, the Subdistributor shall ensure that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
(a) make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
(b) engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
(c) modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
(d) offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
(e) invoice the Customer on behalf of the Distributor for Products sold;
(f) engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
(g) utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
SECTION 2.4 Compliance .
Subdistributor shall conduct its activities and perform the Services and its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such
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laws, rules or regulations, and bear all of its costs and expenses in connection therewith ; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time .
ARTICLE 3
Distributor Obligations
SECTION 3.1 |
Distributor Obligations . During the Term, Distributor shall: |
(a) Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
(b) Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
(c) Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
(d) Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement;
(e) Samples . Distributor shall provide to Subdistributor at no charge samples and prototypes that are not intended for resale. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in ARTICLE 7 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term;
(f) Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time; and
(g) Monthly Reports . Distributor shall keep records of all sales of Products through Subdistributor hereunder and submit to Subdistributor on the fifteenth day of each month a report (“ Monthly Report ”) indicating its total sales through Subdistributor hereunder for the immediately preceding month and the amount of payments received by Distributor with respect to such sales for which Subdistributor is entitled to Compensation under Schedule 4.
ARTICLE 4
Customer Orders
SECTION 4.1 Solicitation of Customer Purchase Orders . All purchase orders solicited by Subdistributor from Customers are subject to approval, rejection or modification by Distributor under
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SECTION 4.2 . Without limiting the generality of SECTION 1.3 , Subdistributor shall have no authority to enter into any Purchase Contract on behalf of Distributor or to otherwise bind Distributor to sell or deliver any Products to Customer. Subdistributor shall promptly notify Distributor with respect to all sales prospects in the Territory, including forwarding to Distributor all Customer purchase orders, requests for quotation and sales inquiries.
SECTION 4.2 Distributor’s Discretion to Accept, Modify or Reject Customer Purchase Orders . Distributor reserves the right, in its sole discretion, to: (a) accept or decline any purchase order for Products received from any party whether or not solicited by Subdistributor; (b) cancel, terminate, or modify any Purchase Contract previously accepted by Distributor; or (c) negotiate any terms and conditions of the Purchase Contract with Customer, including modifying the purchase price or payment terms.
Subdistributor acknowledges that Distributor’s exercise of discretion may result in a reduction of or a delay in the payment of Compensation owed to Subdistributor under this Agreement.
SECTION 4.3 Availability of Products . Distributor may, in its sole discretion, and without advance notice thereof: (a) change the prices, charges and terms of sale of the Products; (b) modify the Products; (c) discontinue the sale of the Products; (d) approve or reject returns, allowances or other adjustments; (e) reduce or allocate its inventory of Products; (f) and effect changes to any of the Products or parts/accessories thereto (except where continued availability is required by Law).
ARTICLE 5
Compensation
SECTION 5.1 Fees and Compensation Payment Terms .
(a) Subject to the terms of the Agreement, Subdistributor shall be compensated for the Services provided under this Agreement (the “ Compensation ”) as outlined in SCHEDULE 4.
(b) With respect to Compensation payable pursuant to SECTION 5.1(a) , Distributor shall pay Subdistributor any Compensation owed for the immediately preceding month within 15 business days of the end of such month.
(c) Distributor shall make all Compensation payments in US dollars by check or wire transfer.
(d) In addition, for purposes of clarification, Subdistributor shall not be entitled to any Compensation or other amounts: (i) for any sale made to an Excluded Customer; (ii) that contravenes any Law; or (iii) in the event Subdistributor is in breach of SECTION 2.3 of the Agreement.
SECTION 5.2 Disputes . Subdistributor shall notify Distributor in writing of any dispute regarding any Monthly Report (along with a reasonably detailed description of the dispute) within 30 days from Subdistributor’s receipt of such Monthly Report. Subdistributor will be deemed to have accepted all Monthly Reports for which Distributor does not receive timely notification of disputes. The Parties shall seek to resolve all such disputes expeditiously and in good faith. Notwithstanding anything to the contrary, Subdistributor shall continue performing its obligations under this Agreement during any such dispute.
SECTION 5.3 Setoff Right . Distributor may withhold payment of any amounts due and payable under this Agreement by reason of any setoff of any claim or dispute with Subdistributor, whether relating to Subdistributor’s breach, bankruptcy or otherwise, or in the event of any refunds, rebates or other adjustments with respect to the sale of a Product affecting previously paid Compensation. To the extent
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there are no anticipated future Compensation payments to be made under this Agreement, Subdistributor shall return any overpayme nts to the Distributor within 7 days following written demand by the Distributor .
ARTICLE 6
IP Rights
SECTION 6.1 Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).:
SECTION 6.2 Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the marketing, promotion, sale and distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
SECTION 6.3 Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
SECTION 6.4 Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
SECTION 6.5 No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
SECTION 7.1 Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to SECTION 7.2 or SECTION 7.3 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
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SECTION 7.2 Distributor ’s Right to Terminate . Distributor may terminate this Agreement by providing written n otice to Subdistributor :
(a) at any time for its convenience upon thirty (30) days prior written notice;
(b) if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
(c) immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
(d) if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
(e) if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
SECTION 7.3 Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor fails to pay any amount when due under this Agreement that is not the subject of a good faith dispute and such failure continues for 10 business days after Distributor’s receipt of written notice of nonpayment; (b) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; (c) or if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
SECTION 7.4 Effect of Expiration or Termination .
(a) Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to SECTION 13.3 and (ii) were incurred by the Parties prior to such expiration or earlier termination; provided that Distributor shall not have any obligation to pay any Compensation with respect to any Products ordered pursuant to any Purchase Contact entered into prior to expiration or termination, but shipped to Customer after such expiration or termination.
(b) Upon the expiration or earlier termination of this Agreement, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized Services provider and sales representative with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iii) permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (iv) certify in writing to Distributor that it has complied with the requirements of this SECTION 7.4(b) .
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SECTION 8.1 Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
(a) is or becomes generally available to the public other than as a result of any direct or indirect breach of this ARTICLE 8 by Subdistributor or any of its Representatives;
(b) is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
(c) was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
(d) was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
(e) is required to be disclosed pursuant to applicable Law.
SECTION 8.2 Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
(a) protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
(b) not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
(c) not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this ARTICLE 8 caused by any of its Representatives.
ARTICLE 9
Subdistributor’s Representations and Warranties
Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; and (f) when executed and delivered by each of Distributor and Subdistributor, this
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Agreement will constitute the legal, valid, and binding obligation of Subdistributor , enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity).
SECTION 10.1 Indemnification . Subject to the terms and conditions set forth in SECTION 10.2 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
SECTION 10.2 Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
SECTION 10.3 DISCLAIMER . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, DISTRIBUTOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 11
Non-Solicitation and Non-Circumvention
SECTION 11.1 During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this ARTICLE 11 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this ARTICLE 11.
SECTION 11.2 Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other
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purpose except solely for the benefit of and as directed by Distributor.
ARTICLE 12
Limitation of Liability
SECTION 12.1 NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
SECTION 12.2 MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT IN THE PRIOR 12 MONTH PERIOD.
ARTICLE 13
Miscellaneous
SECTION 13.1 Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
SECTION 13.2 Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
SECTION 13.3 Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
SECTION 13.4 Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
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SECTION 13.5 Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all n otices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of SECTION 7.1 , SECTION 7.2 , SECTION 7.3 , and Schedule 4 , n otice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this SECTION 13.4 . Except as otherwise provided in this Agreement, a n otice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the n otice has complied with the requirements of this SECTION 13.4 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC __________________________
1565 N. Central Expressway, Suite 220
__________________________
Richardson, TX 75080
__________________________
Attn: Bill McLaughlin, CFO
Attn:
_____________________
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
CPM Medical Consultants, LLC
_________________________]
1565 N. Central Expressway, Suite 220
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: ______________________
Attn: [_____________________]
E-mail:
E-mail: [___________________]
SECTION 13.6 Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
SECTION 13.7 Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
SECTION 13.8 Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
SECTION 13.9 Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
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SECTION 13.10 Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement bet ween the Parties, or otherwise.
SECTION 13.11 Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under ARTICLE 8 or ARTICLE 11 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this SECTION 13.11 .
SECTION 13.12 Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted granting of subdistributor rights in violation of this SECTION 13.12 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
SECTION 13.13 Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
SECTION 13.14 No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
SECTION 13.15 Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
SECTION 13.16 Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
SECTION 13.17 Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in
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connection with Subdistributor ’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any a udit shall be provided to Subdistributor in writing. Any a udit will be conducted during regular business hours at Subdistributor ’s business location .
SECTION 13.18 Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
SECTION 13.19 Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
SECTION 13.20 Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
SECTION 13.21 Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.10
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM MEDICAL CONSULTANTS, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.10
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“ Services” means the marketing, distribution, and sales support services to be provided by Subdistributor as outlined in the Agreement.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.10
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.10
TERRITORY
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SCHEDULE 4
COMPENSATION
Subject to the terms and conditions of the Agreement, Distributor shall pay Subdistributor for the Services provided pursuant to this Agreement, Compensation based upon the following methodologies (which the Parties agree reflects fair value for the Services being provided pursuant to this Agreement):
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Exhibit 10.11
CPM MEDICAL CONSULTANTS, LLC
SALES AND DISTRIBUTION SERVICES AGREEMENT
THIS SALE AND DISTRIBUTION SERVICES AGREEMENT, dated as of March 1 st , 2018 (the “ Agreement ”), is entered into by and between CPM MEDICAL CONSULTANTS, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and _________________ ,a Texas corporation having its principal place of business at __________________________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor provides marketing, distribution and sales support services and wishes to provide Distributor with such support services; and
WHEREAS, Distributor wishes to engage Subdistributor to support its Product marketing, distribution and sales efforts on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1
Appointment
SECTION 1.1 Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive provider of the Services to Distributor in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
SECTION 1.2 Excluded Customers . Notwithstanding SECTION 1.1 , Distributor does not appoint Subdistributor as its provider of the Services for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in sales and marketing activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer. Subdistributor acknowledges and agrees that it is not entitled to any Compensation for any sale made to an Excluded Customer.
SECTION 1.3 Status as Independent Contractor .
|
(a) |
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party. |
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|
(c) |
The Distributor, to the extent applicable, shall issue Subdistributor a Form 1099 for all payments made hereunder. All taxes, withholding and the like on any and all amounts paid under this Agreement shall be solely, and absolutely the Subdistributor’s responsibility. The Subdistributor agrees that it shall indemnify, defend and hold the Distributor and its employees, affiliates, and sales representatives, harmless from and against any judgments, fines, costs or fees associated with such payments hereunder. |
ARTICLE 2
Subdistributor Obligations
SECTION 2.1 |
Services . |
Subdistributor shall perform the following Services during the Term:
(a) Sales and Marketing . Subdistributor shall market, promote, and solicit orders for the Products to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in accordance with Distributor’s Product marketing strategies, channel and pricing guidelines, and sales policies, and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor;
(b) Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a Service provider of the Distributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
(c) Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal
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business hours with general support; and assist the Distributor in training Customers, including surgeons and hospital staff members, on the proper use of the Products ;
(d) Customer Meetings . Subdistributor shall initiate and attend sales calls and meetings with prospective and existing Customers;
(e) Sales and Marketing Plan . Subdistributor shall develop and execute a sales and marketing plan in support of Distributor’s marketing strategy that will include, without limitation, identifying sales opportunities to Distributor within the Territory, and provide support to the Distributor’s contract department on an as needed basis;
(f) Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory. Subdistributor shall receive no compensation with respect to any such inquiries or orders;
(g) Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
(h) Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the Subdistributor policies applicable to Product sales, marketing, customer support, and Product pricing;
(i) Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor in accordance with Section 5.3 below. Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor.
(j) Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
(k) Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address
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and investigate, any c omplaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
(l) Recall Assistance . Subdistributor shall assist the Distributor in effectuating any recall of the Products;
(m) Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
(n) Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
(o) Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review Subdistributor’s performance, Subdistributor’s compliance with Distributor’s Code of Conduct, and other matters pertaining to this Agreement as applicable;
(p) Product Delivery and Operating Room Support . Subdistributor shall schedule the delivery of the Products to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and provide case coverage and arrange for qualified and credentialed Subdistributor Personnel are available and present in the operating room suite to provide the Products and instrumentation associated with the Products and related technical support;
(q) Charge Sheet and Purchase Orders . Subdistributor shall obtain the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker; and obtain the applicable purchase order from the hospital or clinic purchasing or procurement representative;
(r) Litigation Support . Subdistributor shall render reasonable assistance to the Distributor in the defense of any and all product liability claims;
(s) Product Specialists . Subdistributor shall employ at least one Product specialist, acceptable to Distributor, with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
(t) Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier; and
(u) Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
SECTION 2.2 Credentialing and Training .
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To ensure Subdistributor is meeting the highest standards required by Distributor , Subdistributor shall , during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the manufacturer may provide from time to time relative to the Products. In addition, the Subdistributor shall ensure that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
(a) make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
(b) engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
(c) modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
(d) offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
(e) invoice the Customer on behalf of the Distributor for Products sold;
(f) engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
(g) utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
SECTION 2.4 Compliance .
Subdistributor shall conduct its activities and perform the Services and its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such
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laws, rules or regulations, and bear all of its costs and expenses in connection therewith ; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time .
ARTICLE 3
Distributor Obligations
SECTION 3.1 |
Distributor Obligations . During the Term, Distributor shall: |
(a) Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
(b) Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
(c) Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
(d) Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement;
(e) Samples . Distributor shall provide to Subdistributor at no charge samples and prototypes that are not intended for resale. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in ARTICLE 7 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term;
(f) Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time; and
(g) Monthly Reports . Distributor shall keep records of all sales of Products through Subdistributor hereunder and submit to Subdistributor on the fifteenth day of each month a report (“ Monthly Report ”) indicating its total sales through Subdistributor hereunder for the immediately preceding month and the amount of payments received by Distributor with respect to such sales for which Subdistributor is entitled to Compensation under Schedule 4.
ARTICLE 4
Customer Orders
SECTION 4.1 Solicitation of Customer Purchase Orders . All purchase orders solicited by Subdistributor from Customers are subject to approval, rejection or modification by Distributor under
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SECTION 4.2 . Without limiting the generality of SECTION 1.3 , Subdistributor shall have no authority to enter into any Purchase Contract on behalf of Distributor or to otherwise bind Distributor to sell or deliver any Products to Customer. Subdistributor shall promptly notify Distributor with respect to all sales prospects in the Territory, including forwarding to Distributor all Customer purchase orders, requests for quotation and sales inquiries.
SECTION 4.2 Distributor’s Discretion to Accept, Modify or Reject Customer Purchase Orders . Distributor reserves the right, in its sole discretion, to: (a) accept or decline any purchase order for Products received from any party whether or not solicited by Subdistributor; (b) cancel, terminate, or modify any Purchase Contract previously accepted by Distributor; or (c) negotiate any terms and conditions of the Purchase Contract with Customer, including modifying the purchase price or payment terms.
Subdistributor acknowledges that Distributor’s exercise of discretion may result in a reduction of or a delay in the payment of Compensation owed to Subdistributor under this Agreement.
SECTION 4.3 Availability of Products . Distributor may, in its sole discretion, and without advance notice thereof: (a) change the prices, charges and terms of sale of the Products; (b) modify the Products; (c) discontinue the sale of the Products; (d) approve or reject returns, allowances or other adjustments; (e) reduce or allocate its inventory of Products; (f) and effect changes to any of the Products or parts/accessories thereto (except where continued availability is required by Law).
ARTICLE 5
Compensation
SECTION 5.1 Fees and Compensation Payment Terms .
(a) Subject to the terms of the Agreement, Subdistributor shall be compensated for the Services provided under this Agreement (the “ Compensation ”) as outlined in SCHEDULE 4.
(b) With respect to Compensation payable pursuant to SECTION 5.1(a) , Distributor shall pay Subdistributor any Compensation owed for the immediately preceding month within 15 business days of the end of such month.
(c) Distributor shall make all Compensation payments in US dollars by check or wire transfer.
(d) In addition, for purposes of clarification, Subdistributor shall not be entitled to any Compensation or other amounts: (i) for any sale made to an Excluded Customer; (ii) that contravenes any Law; or (iii) in the event Subdistributor is in breach of SECTION 2.3 of the Agreement.
SECTION 5.2 Disputes . Subdistributor shall notify Distributor in writing of any dispute regarding any Monthly Report (along with a reasonably detailed description of the dispute) within 30 days from Subdistributor’s receipt of such Monthly Report. Subdistributor will be deemed to have accepted all Monthly Reports for which Distributor does not receive timely notification of disputes. The Parties shall seek to resolve all such disputes expeditiously and in good faith. Notwithstanding anything to the contrary, Subdistributor shall continue performing its obligations under this Agreement during any such dispute.
SECTION 5.3 Setoff Right . Distributor may withhold payment of any amounts due and payable under this Agreement by reason of any setoff of any claim or dispute with Subdistributor, whether relating to Subdistributor’s breach, bankruptcy or otherwise, or in the event of any refunds, rebates or other adjustments with respect to the sale of a Product affecting previously paid Compensation. To the extent
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there are no anticipated future Compensation payments to be made under this Agreement, Subdistributor shall return any overpayme nts to the Distributor within 7 days following written demand by the Distributor .
ARTICLE 6
IP Rights
SECTION 6.1 Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).:
SECTION 6.2 Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the marketing, promotion, sale and distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
SECTION 6.3 Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
SECTION 6.4 Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
SECTION 6.5 No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
SECTION 7.1 Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to SECTION 7.2 or SECTION 7.3 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
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SECTION 7.2 Distributor ’s Right to Terminate . Distributor may terminate this Agreement by providing written n otice to Subdistributor :
(a) at any time for its convenience upon thirty (30) days prior written notice;
(b) if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
(c) immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
(d) if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
(e) if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
SECTION 7.3 Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor fails to pay any amount when due under this Agreement that is not the subject of a good faith dispute and such failure continues for 10 business days after Distributor’s receipt of written notice of nonpayment; (b) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; (c) or if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
SECTION 7.4 Effect of Expiration or Termination .
(a) Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to SECTION 13.3 and (ii) were incurred by the Parties prior to such expiration or earlier termination; provided that Distributor shall not have any obligation to pay any Compensation with respect to any Products ordered pursuant to any Purchase Contact entered into prior to expiration or termination, but shipped to Customer after such expiration or termination.
(b) Upon the expiration or earlier termination of this Agreement, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized Services provider and sales representative with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iii) permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (iv) certify in writing to Distributor that it has complied with the requirements of this SECTION 7.4(b) .
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SECTION 8.1 Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
(a) is or becomes generally available to the public other than as a result of any direct or indirect breach of this ARTICLE 8 by Subdistributor or any of its Representatives;
(b) is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
(c) was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
(d) was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
(e) is required to be disclosed pursuant to applicable Law.
SECTION 8.2 Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
(a) protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
(b) not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
(c) not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this ARTICLE 8 caused by any of its Representatives.
ARTICLE 9
Subdistributor’s Representations and Warranties
Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; and (f) when executed and delivered by each of Distributor and Subdistributor, this
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Agreement will constitute the legal, valid, and binding obligation of Subdistributor , enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity).
SECTION 10.1 Indemnification . Subject to the terms and conditions set forth in SECTION 10.2 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
SECTION 10.2 Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
SECTION 10.3 DISCLAIMER . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, DISTRIBUTOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 11
Non-Solicitation and Non-Circumvention
SECTION 11.1 During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this ARTICLE 11 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this ARTICLE 11.
SECTION 11.2 Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other
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purpose except solely for the benefit of and as directed by Distributor.
ARTICLE 12
Limitation of Liability
SECTION 12.1 NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
SECTION 12.2 MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT IN THE PRIOR 12 MONTH PERIOD.
ARTICLE 13
Miscellaneous
SECTION 13.1 Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
SECTION 13.2 Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
SECTION 13.3 Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
SECTION 13.4 Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
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SECTION 13.5 Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all n otices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of SECTION 7.1 , SECTION 7.2 , SECTION 7.3 , and Schedule 4 , n otice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this SECTION 13.4 . Except as otherwise provided in this Agreement, a n otice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the n otice has complied with the requirements of this SECTION 13.4 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC __________________________
1565 N. Central Expressway, Suite 220
__________________________
Richardson, TX 75080
__________________________
Attn: Bill McLaughlin, CFO
Attn:
_____________________
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
CPM Medical Consultants, LLC
_________________________]
1565 N. Central Expressway, Suite 220
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: ______________________
Attn: [_____________________]
E-mail:
E-mail: [___________________]
SECTION 13.6 Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
SECTION 13.7 Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
SECTION 13.8 Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
SECTION 13.9 Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
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SECTION 13.10 Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement bet ween the Parties, or otherwise.
SECTION 13.11 Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under ARTICLE 8 or ARTICLE 11 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this SECTION 13.11 .
SECTION 13.12 Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted granting of subdistributor rights in violation of this SECTION 13.12 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
SECTION 13.13 Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
SECTION 13.14 No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
SECTION 13.15 Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
SECTION 13.16 Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
SECTION 13.17 Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in
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connection with Subdistributor ’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any a udit shall be provided to Subdistributor in writing. Any a udit will be conducted during regular business hours at Subdistributor ’s business location .
SECTION 13.18 Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
SECTION 13.19 Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
SECTION 13.20 Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
SECTION 13.21 Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
[ Signatures Next Page.]
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Exhibit 10.11
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM MEDICAL CONSULTANTS, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.11
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.11
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“ Services” means the marketing, distribution, and sales support services to be provided by Subdistributor as outlined in the Agreement.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.11
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
|
• |
Distributor house accounts |
|
• |
Customers outside of the Territory |
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Exhibit 10.11
TERRITORY
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SCHEDULE 4
COMPENSATION
Subject to the terms and conditions of the Agreement, Distributor shall pay Subdistributor for the Services provided pursuant to this Agreement, Compensation based upon the following methodologies (which the Parties agree reflects fair value for the Services being provided pursuant to this Agreement):
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Exhibit 10.12
CPM MEDICAL CONSULTANTS, LLC
SALES AND DISTRIBUTION SERVICES AGREEMENT
THIS SALE AND DISTRIBUTION SERVICES AGREEMENT, dated as of March 1 st , 2018 (the “ Agreement ”), is entered into by and between CPM MEDICAL CONSULTANTS, LLC, a Texas Limited Liability Company having its principal place of business at 1565 N. Central Expressway, Suite 200, Richardson, TX 75080 (“ Distributor ”), and _________________ ,a Texas corporation having its principal place of business at __________________________________________________ (“ Subdistributor ”, and together with Distributor, the “ Parties ,” and each, a “ Party ”).
RECITALS
WHEREAS, Distributor is in the business of marketing and selling the medical Products (as defined in Schedule 1 of this Agreement);
WHEREAS, Subdistributor provides marketing, distribution and sales support services and wishes to provide Distributor with such support services; and
WHEREAS, Distributor wishes to engage Subdistributor to support its Product marketing, distribution and sales efforts on a non-exclusive basis in the Territory, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1
Appointment
SECTION 1.1 Appointment . Distributor hereby appoints Subdistributor, and Subdistributor accepts such appointment, to act as the non-exclusive provider of the Services to Distributor in the Territory during the Term, solely in accordance with the terms and conditions of this Agreement.
SECTION 1.2 Excluded Customers . Notwithstanding SECTION 1.1 , Distributor does not appoint Subdistributor as its provider of the Services for the Excluded Customers. Except as otherwise directed by Distributor, Subdistributor shall not engage in sales and marketing activities or otherwise solicit orders from Excluded Customers and shall promptly refer to the Distributor any sales leads it receives or becomes aware of relating to an Excluded Customer. Subdistributor acknowledges and agrees that it is not entitled to any Compensation for any sale made to an Excluded Customer.
SECTION 1.3 Status as Independent Contractor .
|
(a) |
Subdistributor is an independent contractor under this Agreement. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment, or fiduciary relationship between the Parties or an employee/employer relationship. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Customer or other third party. |
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|
(c) |
The Distributor, to the extent applicable, shall issue Subdistributor a Form 1099 for all payments made hereunder. All taxes, withholding and the like on any and all amounts paid under this Agreement shall be solely, and absolutely the Subdistributor’s responsibility. The Subdistributor agrees that it shall indemnify, defend and hold the Distributor and its employees, affiliates, and sales representatives, harmless from and against any judgments, fines, costs or fees associated with such payments hereunder. |
ARTICLE 2
Subdistributor Obligations
SECTION 2.1 |
Services . |
Subdistributor shall perform the following Services during the Term:
(a) Sales and Marketing . Subdistributor shall market, promote, and solicit orders for the Products to prospective and existing Customers (excluding the Excluded Customers) consistent with good business practice and the highest professional standards in the industry, in each case using its best efforts to maximize Product sales volume in the Territory in accordance with Distributor’s Product marketing strategies, channel and pricing guidelines, and sales policies, and in a manner that reflects favorably at all times on the Products and the good name, goodwill, and reputation of Distributor;
(b) Code of Conduct . Subdistributor shall comply with the Distributor’s Code of Conduct, a copy of which shall be provided to Subdistributor by Distributor from time to time. Subdistributor shall ensure that its Personnel receive a copy of such Code of Conduct and shall provide Distributor signed acknowledgments by such Personnel reflecting the agreement on behalf of the Subdistributor and its Personnel to comply with the standards contained in such Distributor’s Code of Conduct. Subdistributor acknowledges that strict compliance with Distributor’s Code of Conduct is a condition to Subdistributor’s continued appointment as a Service provider of the Distributor. Failure or refusal by Subdistributor and/or its Personnel to strictly comply with such Code of Conduct shall be deemed a material breach of this Agreement;
(c) Customer Support and Training . Subdistributor shall have sufficient knowledge of the industry and products competitive with such Products so as to be able to explain to the Customers the differences between the Products and competing products, to be able to assist the Customer during normal
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business hours with general support; and assist the Distributor in training Customers, including surgeons and hospital staff members, on the proper use of the Products ;
(d) Customer Meetings . Subdistributor shall initiate and attend sales calls and meetings with prospective and existing Customers;
(e) Sales and Marketing Plan . Subdistributor shall develop and execute a sales and marketing plan in support of Distributor’s marketing strategy that will include, without limitation, identifying sales opportunities to Distributor within the Territory, and provide support to the Distributor’s contract department on an as needed basis;
(f) Orders from Outside the Territory . Subdistributor shall promptly refer to Distributor all inquiries and orders received by Subdistributor from customers located outside the Territory. Subdistributor shall receive no compensation with respect to any such inquiries or orders;
(g) Place of Business . Subdistributor shall maintain in the Territory a suitable place of business and adequate facilities to enable it to perform its obligations under this Agreement;
(h) Compliance with Distributor Policies . Subdistributor shall observe all reasonable directions and instructions given to it by Distributor in relation to the marketing, and promotion of the Products, including, without limitation, adhering to the Subdistributor policies applicable to Product sales, marketing, customer support, and Product pricing;
(i) Delivery and Storage of Products and Loaned Instruments . In the event Distributor delivers Loaned Instruments and Products to Subdistributor, Subdistributor, to the extent that it maintains possession of the Loaned Instruments and Products, shall store such Loaned Instruments and Products at Subdistributor’s warehouse or other facility (the “ Facility ”), or at such other storage location away from the Facility, such as a hospital, as the Parties may mutually agree. Subdistributor shall segregate the Loaned Instruments and Products from its other products and inventory and shall clearly identify the Loaned Instruments and Products as property on loan to Distributor through the use of signs, labels or other markings identifying the Loaned Instruments and Products as the property of the Distributor as applicable. Subdistributor shall assume responsibility for any loss, damage, wear, or contamination of the Loaned Instruments and Products following receipt by Subdistributor. Immediately upon any termination or expiration of this Agreement, Subdistributor shall return to Distributor all Loaned Instruments and Products. In the event (i) Subdistributor does not immediately return all such Loaned Instruments and Products, or (ii) Distributor, in its discretion, determines that the Loaned Instruments and Products that are returned are not in a useable condition, Subdistributor shall, at Distributor’s election, within 30 days of any such termination or expiration, either pay to Distributor an amount equal to the Instrument and Products price, as applicable, at an amount equal to the then-current wholesale transfer price or Distributor shall deduct such amount from any amounts otherwise due and payable to Subdistributor in accordance with Section 5.3 below. Further, any Products or Loaned Instruments that are returned (1) damaged, (2) with an expired shelf life or sterile expiration date, or (3) with a breach of package integrity, will not be credited upon returned and the replacement cost equal to then-current wholesale transfer price shall be due and payable from the Subdistributor or will be deducted from any amounts otherwise due and payable to Subdistributor.
(j) Subdistributor’s Role . Subdistributor shall in any and all contact between Subdistributor and any prospective or existing Customer, identify Subdistributor’s role as a representative of Distributor relative to distribution of the Product;
(k) Product Complaints . Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address
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and investigate, any c omplaint or adverse claim about any Product or its use of which Subdistributor becomes aware;
(l) Recall Assistance . Subdistributor shall assist the Distributor in effectuating any recall of the Products;
(m) Excluded Party Notification . Subdistributor shall promptly notify Distributor, to the extent legally permissible to do so, if it or any of its Personnel become an Excluded Party or are otherwise aware of any proceedings that are being brought that may render Subdistributor or any of its Personnel an Excluded Party;
(n) Conflicts of Interest . Subdistributor shall report any actual or potential conflicts of interest to Distributor related to current or prospective future Customers relative to the Products and/or Subdistributor’s obligations under this Agreement;
(o) Periodic Reviews . Subdistributor shall meet with Distributor on an as requested basis at such times as mutually agreed by the Parties to review Subdistributor’s performance, Subdistributor’s compliance with Distributor’s Code of Conduct, and other matters pertaining to this Agreement as applicable;
(p) Product Delivery and Operating Room Support . Subdistributor shall schedule the delivery of the Products to ensure such Products are available in advance of and in time for the applicable surgical or clinical procedure; and provide case coverage and arrange for qualified and credentialed Subdistributor Personnel are available and present in the operating room suite to provide the Products and instrumentation associated with the Products and related technical support;
(q) Charge Sheet and Purchase Orders . Subdistributor shall obtain the charge sheet and/or comparable proof of delivery with appropriate attached patient identifications sticker; and obtain the applicable purchase order from the hospital or clinic purchasing or procurement representative;
(r) Litigation Support . Subdistributor shall render reasonable assistance to the Distributor in the defense of any and all product liability claims;
(s) Product Specialists . Subdistributor shall employ at least one Product specialist, acceptable to Distributor, with the responsibility to guide and assist Subdistributor’s organization maximize sales of the Products. Upon Distributor’s request, Subdistributor shall make this Product specialist available to Distributor for training and consultation;
(t) Product Return . Subdistributor shall obtain prior written consent from Distributor before returning any Product to Supplier; and
(u) Inventory Control . Subdistributor shall to the extent the Product was a consigned item, provide assistance to the hospital or clinic, as applicable, with the inventory assessment and, if necessary, inventory restocking in regards to the Product.
Except as explicitly authorized in this Agreement or in a separate written agreement with Distributor, Subdistributor shall not offer to service, repair, modify, alter, replace, or otherwise change the Products.
SECTION 2.2 Credentialing and Training .
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To ensure Subdistributor is meeting the highest standards required by Distributor , Subdistributor shall , during the Term of the Agreement, ensure its Personnel participate in any training programs that Distributor and/or the manufacturer may provide from time to time relative to the Products. In addition, the Subdistributor shall ensure that its Personnel cooperate with any Customer vendor credentialing requirements which may include, without limitation, Personnel drug screening and criminal background checks.
Notwithstanding anything to the contrary in this Agreement, neither Subdistributor nor its Personnel shall directly or indirectly:
(a) make any representations, warranties, guarantees, indemnities, similar claims, or other commitments: (i) actually, apparently, or on behalf of Distributor or (ii) to any Customer with respect to the Products, which representations, warranties, guarantees, indemnities, similar claims, or other commitments are additional to or inconsistent with any then-existing representations, warranties, guarantees, indemnities, similar claims, or other commitments in this Agreement or any written documentation provided by Distributor to Customer;
(b) engage in any unfair, anti-competitive, misleading, or deceptive practices respecting the Products, including any product disparagement;
(c) modify Products or Product packaging in any way, or supply instrumentation to surgeons for use with the Products without the prior written consent of the Distributor, other than instrumentation supplied by the Distributor;
(d) offer or pay anything of value or other remuneration to any person who may be in a position to procure, influence or otherwise arrange for the ordering or purchasing of the Products;
(e) invoice the Customer on behalf of the Distributor for Products sold;
(f) engage in any direct contact with beneficiaries of any Federal or state health care programs relative to the Products and Subdistributor’s obligations under this Agreement; and
(g) utilize any healthcare professionals or persons in a similar position to exert undue influence on Customers, prospective customers, or patients relative to the purchase or utilization of the Products and Subdistributor’s obligations under this Agreement.
Notwithstanding any language to the contrary, Subdistributor understands and agrees that any breach of this Section 3.4 shall be deemed a material breach of this Agreement and, in addition to any other rights and remedies available to Distributor in law or equity, Subdistributor shall forfeit any amounts that are due or payable under this Agreement.
SECTION 2.4 Compliance .
Subdistributor shall conduct its activities and perform the Services and its obligations under this Agreement in accordance and consistent with (i) all applicable federal and state laws, rules and regulations (including, without limitation, the laws of the Territory, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the federal Stark Law (42 U.S.C. §1395nn), the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA), or any other similar federal or state statute of any applicable regulations promulgated thereunder) and establish and implement any control procedures required to comply with such
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laws, rules or regulations, and bear all of its costs and expenses in connection therewith ; and (ii) the Distributor’s then-current policies and rules, as may be amended from time to time .
ARTICLE 3
Distributor Obligations
SECTION 3.1 |
Distributor Obligations . During the Term, Distributor shall: |
(a) Information and Support . Distributor shall provide any information and support reasonably requested by Subdistributor regarding the marketing, promotion, solicitation of orders, and distribution of Products under this Agreement;
(b) Program Participation . Distributor shall allow Subdistributor to participate in any marketing, promotion, sales and distribution programs that Distributor may make generally available to its authorized sales representatives of Products, provided that Distributor shall have the right to alter or eliminate any such program at any time;
(c) Promotional Material Review . Distributor shall approve or reject, in its reasonable discretion, any promotional information or material submitted by Subdistributor for Distributor’s approval within 30 days of receipt;
(d) Product Promotional Information . Distributor shall provide reasonable quantities usually made available by Distributor to its sales representatives and distributors of current English-language Product promotional information and material for use by Subdistributor in accordance with this Agreement;
(e) Samples . Distributor shall provide to Subdistributor at no charge samples and prototypes that are not intended for resale. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in ARTICLE 7 . Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term;
(f) Loaned Instruments . Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “ Loaned Instruments ”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time; and
(g) Monthly Reports . Distributor shall keep records of all sales of Products through Subdistributor hereunder and submit to Subdistributor on the fifteenth day of each month a report (“ Monthly Report ”) indicating its total sales through Subdistributor hereunder for the immediately preceding month and the amount of payments received by Distributor with respect to such sales for which Subdistributor is entitled to Compensation under Schedule 4.
ARTICLE 4
Customer Orders
SECTION 4.1 Solicitation of Customer Purchase Orders . All purchase orders solicited by Subdistributor from Customers are subject to approval, rejection or modification by Distributor under
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SECTION 4.2 . Without limiting the generality of SECTION 1.3 , Subdistributor shall have no authority to enter into any Purchase Contract on behalf of Distributor or to otherwise bind Distributor to sell or deliver any Products to Customer. Subdistributor shall promptly notify Distributor with respect to all sales prospects in the Territory, including forwarding to Distributor all Customer purchase orders, requests for quotation and sales inquiries.
SECTION 4.2 Distributor’s Discretion to Accept, Modify or Reject Customer Purchase Orders . Distributor reserves the right, in its sole discretion, to: (a) accept or decline any purchase order for Products received from any party whether or not solicited by Subdistributor; (b) cancel, terminate, or modify any Purchase Contract previously accepted by Distributor; or (c) negotiate any terms and conditions of the Purchase Contract with Customer, including modifying the purchase price or payment terms.
Subdistributor acknowledges that Distributor’s exercise of discretion may result in a reduction of or a delay in the payment of Compensation owed to Subdistributor under this Agreement.
SECTION 4.3 Availability of Products . Distributor may, in its sole discretion, and without advance notice thereof: (a) change the prices, charges and terms of sale of the Products; (b) modify the Products; (c) discontinue the sale of the Products; (d) approve or reject returns, allowances or other adjustments; (e) reduce or allocate its inventory of Products; (f) and effect changes to any of the Products or parts/accessories thereto (except where continued availability is required by Law).
ARTICLE 5
Compensation
SECTION 5.1 Fees and Compensation Payment Terms .
(a) Subject to the terms of the Agreement, Subdistributor shall be compensated for the Services provided under this Agreement (the “ Compensation ”) as outlined in SCHEDULE 4.
(b) With respect to Compensation payable pursuant to SECTION 5.1(a) , Distributor shall pay Subdistributor any Compensation owed for the immediately preceding month within 15 business days of the end of such month.
(c) Distributor shall make all Compensation payments in US dollars by check or wire transfer.
(d) In addition, for purposes of clarification, Subdistributor shall not be entitled to any Compensation or other amounts: (i) for any sale made to an Excluded Customer; (ii) that contravenes any Law; or (iii) in the event Subdistributor is in breach of SECTION 2.3 of the Agreement.
SECTION 5.2 Disputes . Subdistributor shall notify Distributor in writing of any dispute regarding any Monthly Report (along with a reasonably detailed description of the dispute) within 30 days from Subdistributor’s receipt of such Monthly Report. Subdistributor will be deemed to have accepted all Monthly Reports for which Distributor does not receive timely notification of disputes. The Parties shall seek to resolve all such disputes expeditiously and in good faith. Notwithstanding anything to the contrary, Subdistributor shall continue performing its obligations under this Agreement during any such dispute.
SECTION 5.3 Setoff Right . Distributor may withhold payment of any amounts due and payable under this Agreement by reason of any setoff of any claim or dispute with Subdistributor, whether relating to Subdistributor’s breach, bankruptcy or otherwise, or in the event of any refunds, rebates or other adjustments with respect to the sale of a Product affecting previously paid Compensation. To the extent
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there are no anticipated future Compensation payments to be made under this Agreement, Subdistributor shall return any overpayme nts to the Distributor within 7 days following written demand by the Distributor .
ARTICLE 6
IP Rights
SECTION 6.1 Ownership . Subdistributor acknowledges and agrees that Distributor’s IP Rights are the sole and exclusive property of Distributor and its licensors (if applicable) and that Subdistributor shall not acquire any ownership interest in any such Distributor IP Rights and use of such Distributor IP Rights permitted under this Agreement are for the sole purpose of Subdistributor performing its obligations under this Agreement. Any goodwill derived from the use by Subdistributor of Distributor’s IP Rights shall inure to the benefit of Distributor or its licensors (as the case may be).:
SECTION 6.2 Distributor’s Trademark License Grant . Subject to the terms and conditions of this Agreement, Distributor hereby grants to Subdistributor a non-exclusive, non-transferable, and non-sublicensable license to use Distributor’s Trademarks in the Territory during the Term solely in connection with the marketing, promotion, sale and distribution of the Products. Subdistributor will promptly discontinue the display or use of any Trademark or change the manner in which a Trademark is displayed or used with regard to the Products when requested by Distributor.
SECTION 6.3 Marketing and Resale Right Only . Subdistributor is authorized to market the Products only in the form and packaging as authorized by Distributor to Subdistributor. Other than the express licenses granted by this Agreement, Distributor grants no right or license to Subdistributor by implication, estoppel, or otherwise to the Products or any of Distributor’s IP Rights.
SECTION 6.4 Prohibited IP Acts . Subdistributor shall not, and shall not cause or encourage Customers to: (a) take any action that may interfere with any of Distributor’s IP Rights; (b) make any claim or take any action adverse to Distributor’s ownership of Distributor’s IP Rights; (c) register or apply for registrations, anywhere in the world, for Distributor’s Trademarks or any other Trademark that is similar to Distributor’s Trademarks or that incorporates Distributor’s Trademarks; (d) use any mark, anywhere, that is confusingly similar to Distributor’s Trademarks; (e) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the products purchased under this Agreement (including Products) or any Distributor Trademark; (f) misappropriate any of Distributor’s Trademarks for use as a domain name without prior written consent from Distributor; and (g) alter, obscure or remove any of Distributor’s Trademarks or trademark or copyright notices or any other proprietary rights notices placed on the products purchased under this Agreement (including Products), marketing materials, or other materials that Distributor may provide.
SECTION 6.5 No Continuing Rights . On termination of this Agreement, Subdistributor will immediately cease all display, advertising, promotion, and use of all of Distributor’s Trademark.
SECTION 7.1 Term . The term of this Agreement commences on the Effective Date and, unless earlier terminated pursuant to SECTION 7.2 or SECTION 7.3 , shall continue in effect for an initial Term of one (1) year; thereafter, the Agreement shall renew for additional one (1) year periods until it is terminated by either Party by providing at least 30 days advance written notice to the other Party (the “ Term ”).
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SECTION 7.2 Distributor ’s Right to Terminate . Distributor may terminate this Agreement by providing written n otice to Subdistributor :
(a) at any time for its convenience upon thirty (30) days prior written notice;
(b) if Subdistributor materially breaches any provision of this Agreement and fails to render a cure within fifteen days of receipt of written notice of breach;
(c) immediately in the event Subdistributor breaches Section 2.4 ( Prohibited Acts ) of this Agreement;
(d) if Subdistributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due; or
(e) if Subdistributor sells, transfers or disposes of all or substantially all of its assets, or merges or consolidates with any other entity.
SECTION 7.3 Subdistributor’s Right to Terminate . Subdistributor may terminate this Agreement upon written notice to Distributor: (a) if Distributor fails to pay any amount when due under this Agreement that is not the subject of a good faith dispute and such failure continues for 10 business days after Distributor’s receipt of written notice of nonpayment; (b) if Distributor materially breaches any provision of this Agreement and fails to render cure within the cure period; (c) or if Distributor becomes insolvent or files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency Law, makes or seeks to make a general assignment for the benefit of its creditors, or applies for, or consents to, the appointment of a trustee, receiver, or custodian for a substantial part of its property, or is generally unable to pay its debts as they become due.
SECTION 7.4 Effect of Expiration or Termination .
(a) Expiration or termination of the Term will not affect any rights or obligations that (i) are to survive the expiration or earlier termination of this Agreement pursuant to SECTION 13.3 and (ii) were incurred by the Parties prior to such expiration or earlier termination; provided that Distributor shall not have any obligation to pay any Compensation with respect to any Products ordered pursuant to any Purchase Contact entered into prior to expiration or termination, but shipped to Customer after such expiration or termination.
(b) Upon the expiration or earlier termination of this Agreement, Subdistributor shall promptly: (i) cease to represent itself as Distributor’s authorized Services provider and sales representative with respect to the Products, and shall otherwise desist from all conduct or representations that might lead the public to believe that Subdistributor is authorized by Distributor to market, distribute or solicit sales of the Products; (ii) return to Distributor all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on Distributor’s Confidential Information; (iii) permanently erase all of Distributor’s Confidential Information from its computer systems, except for copies that are maintained as archive copies on its disaster recovery and/or information technology backup systems (provided, however, Subdistributor shall destroy any such copies upon the normal expiration of its backup files); and (iv) certify in writing to Distributor that it has complied with the requirements of this SECTION 7.4(b) .
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SECTION 8.1 Scope of Confidential Information . From time to time during the Term, Distributor may disclose or make available to Subdistributor information about its business affairs, goods and services, pricing, forecasts, customers, confidential information, and materials comprising or relating to IP Rights, trade secrets, third-party confidential information, and other sensitive or proprietary information, as well as the terms of this Agreement (collectively, “ Confidential Information ”). Confidential Information does not include information that, at the time of disclosure:
(a) is or becomes generally available to the public other than as a result of any direct or indirect breach of this ARTICLE 8 by Subdistributor or any of its Representatives;
(b) is or becomes available to Subdistributor on a non-confidential basis from a third party, provided that such third party is not under a duty of confidentiality to Distributor;
(c) was known by or in the possession of Subdistributor or its Representatives prior to being disclosed by or on behalf of Distributor;
(d) was or is independently developed by Subdistributor without reference to or use of any of Distributor’s Confidential Information; or
(e) is required to be disclosed pursuant to applicable Law.
SECTION 8.2 Protection of Confidential Information . During the Term of this Agreement and thereafter, Subdistributor shall:
(a) protect and safeguard the confidentiality of Distributor’s Confidential Information with at least the same degree of care as Subdistributor would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;
(b) not use Distributor’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and
(c) not disclose any such Confidential Information to any Person, except to Subdistributor’s Representatives who need to know the Confidential Information to assist Subdistributor, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
Subdistributor shall be responsible for any breach of this ARTICLE 8 caused by any of its Representatives.
ARTICLE 9
Subdistributor’s Representations and Warranties
Subdistributor represents and warrants to Distributor that: (a) it is a duly organized, validly existing, and in good standing in the jurisdiction of its formation; (b) it is qualified and licensed to do business and in good standing in every jurisdiction where such qualification and licensing is required for purposes of this Agreement; (c) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under this Agreement and to perform its obligations under this Agreement; (d) the execution of this Agreement by its Representative whose signature is set forth at the end hereof has been duly authorized by all necessary action of Subdistributor; (e) neither Subdistributor nor its Personnel are an Excluded Party; and (f) when executed and delivered by each of Distributor and Subdistributor, this
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Agreement will constitute the legal, valid, and binding obligation of Subdistributor , enforceable against Subdistributor in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting creditors’ rights generally or the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity).
SECTION 10.1 Indemnification . Subject to the terms and conditions set forth in SECTION 10.2 , Subdistributor shall indemnify, hold harmless, and defend Distributor and its officers, directors, employees, agents, affiliates, successors, and permitted assigns (collectively, “ Indemnified Party ”) against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorney fees, fees and the costs of enforcing any right to indemnification under this Agreement, and the cost of pursuing any insurance providers, incurred by Indemnified Party (collectively, “ Losses ”), relating to, arising out of or resulting from any Claim alleging: (a) breach of this Agreement by Subdistributor or its Personnel; (b) any grossly negligent, negligent, fraudulent, or more culpable act or omission of Subdistributor or its Personnel (including any recklessness or willful misconduct) in connection with the performance of its obligations under this Agreement; (c) or any bodily injury, death of any Person or damage to real or tangible personal property caused by the willful or grossly negligent acts or omissions of Subdistributor or its Personnel.
SECTION 10.2 Exceptions and Limitations on General Indemnification . Notwithstanding anything to the contrary in this Agreement, Subdistributor is not obligated to indemnify, hold harmless or defend Indemnified Party against any third party Claim to the extent such third party Claim or corresponding Losses arise out of or result from Indemnified Party’s or its Personnel’s: gross negligence or willful misconduct.
SECTION 10.3 DISCLAIMER . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, DISTRIBUTOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS SOLD UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 11
Non-Solicitation and Non-Circumvention
SECTION 11.1 During the Term and for a period of 12 months thereafter, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner make any solicitation to employ the Distributor’s Personnel without written consent of Distributor. For the purposes of this ARTICLE 11 , a general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet, shall not be construed as a solicitation or inducement, and the hiring of any such employees or independent contractor who freely responds thereto is not a breach of this ARTICLE 11.
SECTION 11.2 Notwithstanding any language to the contrary, during the Term and continuing thereafter until such time as Distributor’s Confidential Information and Trade Secrets no longer constitute Confidential Information of Distributor, Subdistributor shall not, and shall not permit its Representatives to, directly or indirectly, in any manner utilize Distributor’s Confidential Information and Trade Secrets (which may include without limitation confidential pricing, the terms of Distributor’s agreements with third parties, and/or product catalogs) for the purposes of circumventing, interfering with, or for any other
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purpose except solely for the benefit of and as directed by Distributor.
ARTICLE 12
Limitation of Liability
SECTION 12.1 NO LIABILITY FOR CONSEQUENTIAL OR INDIRECT DAMAGES . EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
SECTION 12.2 MAXIMUM LIABILITY FOR DIRECT DAMAGES . EXCEPT FOR OBLIGATIONS TO MAKE PAYMENT UNDER THIS AGREEMENT, LIABILITY FOR INDEMNIFICATION AS SET FORTH IN THIS AGREEMENT, LIABILITY FOR BREACH OF CONFIDENTIALITY OR IN THE CASE OF SUBDISTRIBUTOR BREACH OF SECTION 2.3, OR LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF IP RIGHTS, IN NO EVENT SHALL EITHER PARTY’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE AGGREGATE AMOUNT PAID TO SUBDISTRIBUTOR PURSUANT TO THIS AGREEMENT IN THE PRIOR 12 MONTH PERIOD.
ARTICLE 13
Miscellaneous
SECTION 13.1 Further Assurances . Upon either Party’s reasonable request, the other Party shall execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.
SECTION 13.2 Entire Agreement . This Agreement, including and together with all exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.
SECTION 13.3 Attorney’s Fees . In the event that there is any controversy or claim arising out of or relating to this Agreement, or to the interpretation, breach or enforcement thereof, and any action or proceeding is commenced to enforce the provisions of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and expenses.
SECTION 13.4 Survival . Where the Parties’ rights and obligations under this Agreement by their terms or by their nature extend or are contemplated to extend beyond the end of the Term, they will be deemed to survive any termination or expiration of this Agreement for as long as necessary to give full force and effect to such rights and obligations of the Parties.
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SECTION 13.5 Notices . Each Party shall deliver all notices, requests, consents, claims, demands, waivers and other communications under this Agreement in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this section). Each Party shall deliver all n otices by personal delivery, nationally recognized overnight courier, or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, for the purposes of SECTION 7.1 , SECTION 7.2 , SECTION 7.3 , and Schedule 4 , n otice given by facsimile or e-mail (with confirmation of transmission) will satisfy the requirements of this SECTION 13.4 . Except as otherwise provided in this Agreement, a n otice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the n otice has complied with the requirements of this SECTION 13.4 .
If to Distributor: If to Subdistributor:
CPM Medical Consultants, LLC __________________________
1565 N. Central Expressway, Suite 220
__________________________
Richardson, TX 75080
__________________________
Attn: Bill McLaughlin, CFO
Attn:
_____________________
E-mail:
bmclaughlin@surgicalservice.comE-mail: [___________________]
With a copy to: With a copy to:
CPM Medical Consultants, LLC
_________________________]
1565 N. Central Expressway, Suite 220
[__________________________]
Richardson, TX 75080
[__________________________]
Attn: ______________________
Attn: [_____________________]
E-mail:
E-mail: [___________________]
SECTION 13.6 Interpretation . The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.
SECTION 13.7 Headings . The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.
SECTION 13.8 Severability . If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.
SECTION 13.9 Amendment; Modification; Waiver . No amendment to this Agreement is effective unless it is in writing and signed by an authorized Representative of each Party. No waiver by either Party shall be effective against such Party unless expressed in writing and signed by that Party. No failure or delay by any party hereto in exercising any right, power or privilege hereunder (and no course of dealing between or among any of the parties) shall operate as a waiver of any such right, power or privilege. No waiver of any default on any one occasion shall constitute a waiver of any subsequent or other default.
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SECTION 13.10 Cumulative Remedies . All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement bet ween the Parties, or otherwise.
SECTION 13.11 Equitable Remedies . Subdistributor acknowledges and agrees that (a) a breach or threatened breach of any of its obligations under ARTICLE 8 or ARTICLE 11 would give rise to irreparable harm to Distributor for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Subdistributor of any such obligations, Distributor shall, in addition to any and all other rights and remedies that may be available to Distributor at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Subdistributor agrees that Subdistributor will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this SECTION 13.11 .
SECTION 13.12 Assignment and Subcontracting . Subdistributor may not assign or otherwise subcontract any of its rights or delegate any of its obligations or appoint any subdistributors under this Agreement without the prior written consent of Distributor. Any purported assignment or delegation or subcontracting or attempted granting of subdistributor rights in violation of this SECTION 13.12 is null and void. No permitted assignment or delegation or subcontracting relieves the assigning or delegating or subcontracting Party of any of its obligations under this Agreement. The foregoing notwithstanding, Distributor may assign any of its rights or delegate any of its obligations to any affiliate or subsidiary or to any Person acquiring all or substantially all of Distributor’s assets.
SECTION 13.13 Successors and Assigns . This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
SECTION 13.14 No Third Party Beneficiaries . No third party shall be considered a third-party beneficiary under this Agreement, nor shall any third party have any rights as a result of this Agreement.
SECTION 13.15 Choice of Law . This Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Texas, without regard to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the Laws of any jurisdiction other than those of the State of Texas.
SECTION 13.16 Access to Books and Records . Upon the written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Subdistributor and any of its affiliates providing services with a value or cost of $10,000.00 or more over a twelve (12) month period shall make available to the Secretary the contracts, books, documents and records that are necessary to verify the nature and extent of the cost of providing such services. Such inspection shall be available up to four (4) years after the rendering of such services. The Parties agree that any applicable attorney client, accountant client or other legal privilege shall not be deemed waived by virtue of this Agreement.
SECTION 13.17 Audits . During the Term, but no more than once annually, unless related to a breach of this Agreement, Distributor shall have the right to audit the books and records of Subdistributor in
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connection with Subdistributor ’s obligations and performance under this Agreement. Such audit may be conducted by Distributor and/or a third party auditor. The results of any a udit shall be provided to Subdistributor in writing. Any a udit will be conducted during regular business hours at Subdistributor ’s business location .
SECTION 13.18 Choice of Forum . Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments, and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the courts of the State of Texas sitting in Dallas County, and any appellate court from thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding only in the courts of the State of Texas sitting in Dallas County. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.
SECTION 13.19 Waiver of Jury Trial . Each Party agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, AND attachments attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section.
SECTION 13.20 Counterparts . This Agreement may be executed in any number of counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
SECTION 13.21 Force Majeure . No Party shall be liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and to the extent such failure or delay is caused by or results from acts beyond the affected Party’s reasonable control, including, without limitation: (a) acts of God; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest; (d) Law; (e) actions, embargoes, or blockades in effect on or after the date of this Agreement; (f) action by any Governmental Authority; (g) national or regional emergency; (h) strikes, labor stoppages or slowdowns, or other industrial disturbances; and (i) shortage of adequate power or transportation facilities.
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Exhibit 10.12
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.
DISTRIBUTOR:
CPM MEDICAL CONSULTANTS, LLC
By:
Name:
Title:
SUBDISTRIBUTOR:
[________________________]
By:
Name:
Title:
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Exhibit 10.12
DEFINITIONS
Capitalized terms have the meanings set forth or referred to in this Schedule 1, or in the Section in which they first appear in this Agreement.
“ Claim ” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.
“ Customer ” means those specific surgeons and the hospitals and clinics where they conduct surgeries using the Distributor’s Product.
“ Distributor’s IP Rights ” means all IP Rights owned by or licensed to Distributor.
“ Distributor’s Trademarks ” means all Trademarks owned or licensed by Distributor.
“ Excluded Customer ” means Governmental Authorities, Distributor’s house accounts and other accounts listed in attached Schedule 2 (which Distributor may periodically update in its sole discretion), or a customer located outside of the Territory.
“ Excluded Party ” means any Person that is excluded, debarred, or otherwise ineligible to participate in any Federal Healthcare Program, and for purposes of this Agreement also includes any Person that has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the Federal Healthcare Programs after a period of exclusion, debarment or ineligibility.
“ Federal Healthcare Program ” has the meaning set forth in 42 U.S.C. §1320a-7b(f).
“ Governmental Authority ” means any federal, state, local, or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political
subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court, or tribunal of competent jurisdiction.
“ IP Rights ” means all: (a) Patents; (b) Trademarks; (c) internet domain names, web addresses, web pages, websites, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, and firmware; (e) Trade Secrets; and (f) all other intellectual property and industrial property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.
“ Instruments ” shall mean all instruments used in connection with the Products, as identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Law ” means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority, or other requirement or rule of law of any Governmental Authority.
“ Person ” means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
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Exhibit 10.12
“ Personnel ” means agents, employees, or subcontractors engaged or appointed by any Party.
“ Products ” means those products that are identified in an applicable Product catalog or other supplier product information sheet as provided by Distributor.
“ Purchase Contract ” means a contract or written arrangement entered into between the Distributor and a Customer for the sale and purchase of Product(s) in the Territory by Distributor to such Customer.
“ Representatives ” means a Party’s affiliates, employees, officers, directors, successors, and permitted assigns.
“ Services” means the marketing, distribution, and sales support services to be provided by Subdistributor as outlined in the Agreement.
“ Trademarks ” means all rights in and to United Sates and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, in each case whether registered or unregistered.
“
Trade Secrets
” means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information, and all rights therein.
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Exhibit 10.12
EXCLUDED CUSTOMERS
|
• |
Governmental Authorities |
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• |
Distributor house accounts |
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• |
Customers outside of the Territory |
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Exhibit 10.12
TERRITORY
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SCHEDULE 4
COMPENSATION
Subject to the terms and conditions of the Agreement, Distributor shall pay Subdistributor for the Services provided pursuant to this Agreement, Compensation based upon the following methodologies (which the Parties agree reflects fair value for the Services being provided pursuant to this Agreement):
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Exhibit 10.13
PRIVATE LABEL SUPPLY AGREEMENT
THIS PRIVATE LABEL SUPPLY AGREEMENT (“ Agreement ”) is entered as of November 1, 2016 (the “ Effective Date ”), by and between Tyber Medical, LLC, a New Jersey limited liability company (“ Supplier ”) and CPM Medical Consultants, LLC, a Texas Liability Corporation (“ Distributor ”).
R E C I T A L S
WHEREAS, Supplier is engaged in the business of developing innovative medical devices for private label opportunities including the development, production, and distribution of proprietary medical devices.
WHEREAS, Distributor is engaged in the business of designing, manufacturing and selling products and instruments relating to orthopaedic surgery.
WHEREAS, Distributor desires to acquire and distribute Supplier’s implants and consumables described on Schedule 1 (each an “ Implant ” and collectively the “ Implants ”) and the instruments required for implantation thereof (the “ Instruments ” and collectively with the Implants, the “ Products ”) under the Distributor’s own respective brand names, and Supplier is willing to supply such Products to Distributor, in accordance with the terms and conditions set forth in this Agreement. Distributor and Supplier may create an addendum to this Agreement to add additional products by mutually agreeing upon a revised or additional Schedule 1 , from time to time, by written agreement.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties agree as follows:
|
1. |
Manufacture and Supply . |
(a) General . During the term of this Agreement, Supplier shall produce, package and supply the Products to Distributor, and Distributor shall acquire the Products from Supplier, pursuant to the terms and provisions set forth herein. Instruments for Implants must be purchased from Supplier unless Distributor implements a proper quality system that complies with ISO 13485 and all applicable regulations, and which system can be verified by Supplier and is satisfactory to Supplier, as determined in its sole discretion. Subject to mutual agreement as to scope and pricing, Supplier agrees to provide Instrument customization and additional graphic design images of Implants contained within a relevant model.
(b) Implant Packaging and Brand Names . The Implants shall be finally packaged by Supplier using the trade names and artwork specified on Schedule 2 , as the name may be modified from time to time upon written notice by Distributor (the “ Private Label Brands ”). Supplier’s name shall not appear on labels unless required by law and, if required by law, shall be included only to the extent (including size and location) specifically required. Any changes to Supplier’s existing packaging or labeling, including any artwork changes, will be paid for by Distributor. Distributor shall pay to Supplier the non-refundable sum of $5,000 for the first product family and $2,500 for each product family thereafter for packaging, labeling, labeling content and artwork for the Implants concurrently with the execution of this Agreement (the “ Initial Packaging Fee ”). Distributor shall not make any additional changes to the packaging, labeling, labeling content or artwork for the Implants after purchase from Supplier without Supplier’s prior written consent.
(c) Obsolescence . If Supplier plans to discontinue any Product, Supplier shall provide Distributor written notice at least 180 days in advance of the effect of such change (unless impractical for regulatory reasons, in which case such notice shall be provided immediately after the need to discontinue the Product is determined by Supplier).
(d) Changes to Products for Regulatory Reasons . Supplier shall have the right to modify the Products as necessary to comply with changes in applicable law or regulatory approvals. If Supplier is required to materially modify any Product, Supplier shall provide Distributor written notice at least thirty (30) days in advance of the effect of such change (unless impractical for regulatory reasons, in which case such notice shall be provided immediately after the need to materially modify the Product is determined by Supplier). In the event that Supplier makes a change to the Products in accordance with this Section, Supplier shall provide Distributor with information on the changes, and corresponding updated guidelines and instructions for use. In addition, in the event of a recall involving any Products
Exhibit 10.13
currently held in Distributor’s inventory , Supplier shall provide replacement Products and Samples for Distributor’s current stock of such recalled Products , and Distributor shall return all old stock to Supplier at Supplier’s expense.
(e) Changes to Products for Other Reasons by Supplier . If Supplier materially modifies any Product for reasons other than to comply with law or regulatory approvals Supplier shall provide Distributor with information on the changes and corresponding updated guidelines and instructions for use, if required. If such change renders Distributor’s stock of Products unsaleable or unusable, as determined by Supplier in its reasonable discretion, Supplier shall, at Supplier’s expense, provide Distributor with replacement Products sufficient to replace such stock.
(f) Samples . Supplier shall make available for purchase by Distributor a reasonable number of samples of non-implantable Implants and demonstration Instruments for use only for demonstration and training purposes (the “ Samples ”).
(g) Inspection . Distributor shall have the right, on written notice given not less than fifteen (15) days in advance of written notice to Supplier, and not more frequently than twice in any calendar year, during Supplier’s regular business hours, to inspect Supplier’s quality system and facilities relating to the performance of Supplier’s duties hereunder.
(h) New Devices . Supplier agrees to allow Distributor the opportunity to include in this Agreement all available new medical devices developed by Supplier during the Initial Term on terms mutually agreed upon. Subject to Distributor’s confidentiality obligations set forth in Section 10 hereof, Supplier shall use commercially reasonable efforts to notify Distributor of new products.
(i) Ownership . As between Distributor and Supplier, Supplier retains and shall be the sole owner of all right, title, and interest to (i) all drawings, models and test data relating to the Products; (ii) all improvements relating to the Products; (iii) the design history file documents and all other regulatory documents and all regulatory approvals for the Products; and (iv) all intellectual property rights related to the foregoing. As between Distributor and Supplier, Distributor retains and shall be the sole owner of all intellectual property rights in and to the Private Label Brands, all data relating to End Users and other customers provided to Supplier, and all Marketing Materials (as defined herein).
(j) Quality and Regulatory Agreement . Upon Supplier’s reasonable request, Supplier and Distributor shall complete and maintain a mutually agreed upon Quality and Regulatory agreement.
2. Price, Orders, and Terms Of Payment .
(a) Product Costs . Distributor shall acquire the Products for the amount set forth on Schedule 3 (the “ Product Cost ”) and shall be fixed for the Term of this Agreement.
(b) Sample Costs . Distributor shall acquire Samples at the amounts for such Samples set forth on Schedule 3 , as may be amended from time to time (the “ Sample Cost ”).
(c) Exclusive Acquisition Commitment .
(i) Distributor agrees to acquire all of its requirements for the Products described in Schedule 1 from Supplier for the duration of the agreement.
(ii) In the event Distributor fails to acquire at least $50,000 of Products in any rolling twelve (12) month period (the “ Minimum Acquisition Commitment ”), Supplier may (but shall not be obligated to) notify Distributor in writing of the amount of any shortfall between the Minimum Acquisition Commitment for such rolling period and the amount of Product actually acquired in such rolling period (the “ Shortfall Amount ”) and request Distributor to provide Supplier with written detail of the reason(s) for such shortfall. Distributor may order and pay within forty-five (45) days of the date of the notice the amount of Products that is at least equal to the Shortfall Amount. Following such payment, over a period of no more than twelve (12) months, the Supplier shall deliver to Distributor, at times and in any mix (including Samples) reasonably requested by Distributor, Products with an aggregate value equal to such Shortfall Amount payment (in addition to any Minimum Acquisition Commitment applicable to such period). If Distributor does not pay the Shortfall Amount within such forty-five-day period, Supplier, in its sole discretion, shall have the right to terminate this Agreement for cause at any time effective upon written notice to Distributor.
(d) Forecast and Orders .
(i) Acquisition Order . The initial acquisition order shall be $ 426,324.50 , and shall be submitted to Supplier concurrently upon the signing of this Agreement. The parties anticipate the first delivery of Products to occur within one hundred twenty (120) days from Distributor’s date of delivery of camera ready artwork for labeling and packaging
Exhibit 10.13
and mutually agreed upon production specifications . The parties anticipate (but do not guarantee) delivery of subsequent Products to occur within ninety ( 90 ) days from Supplier’s acceptance of an acquisition order. After the initial order the Distributor will provide a rolling 6 month forecast on the first of each calendar month. Forecasts will be used solely for business planning purposes ; Distributor understands that, while it is helpful to provide accurate forecasts, no orders or any other irreversible action will be taken based on a forecast.
(ii) Variances due to Supply Shortages or Overages . In the event that Supplier suffers a shortage of Product supply, including any shortage due to a failure of Supplier’s own supply chain, which renders Supplier unable to manufacture Products in quantities in any acquisition order accepted by Supplier, Supplier may allocate its available production for Products to Distributor and its other customers, including any customers to which it supplies Products directly, in any commercially reasonable manner. In connection with Supplier’s production run of a Product, Supplier plans for over production of the Product by at least 5% to account for anticipated waste. If any or all of such over production units meet the Product specifications and pass quality inspection, Supplier shall deliver, and Distributor agrees to purchase, such additional Products up to 5% of the corresponding acquisition order in accordance with the pricing terms herein.
(iii) Order Quantity Limits . All acquisition orders for Products must specify a quantity of at least 50 units total (any Product mix) with no more than 3 lots. Any order quantity outside these limits will require a new price quote from Supplier.
(e) Payment Terms . All amounts are payable only in U.S. Dollars. Except as otherwise set forth under this Agreement, Distributor will be required to pay thirty five percent (35%) of the total Product Cost and Sample Cost for Products ordered upon issuance of the acquisition. The balance shall be split into two (2) equal payments due one-half (1/2) thirty (30) days after from the receipt of Supplier’s invoice and the remaining one-half (1/2) sixty (60) days after from the receipt of Supplier’s invoice. Notwithstanding the foregoing, if the first of such two payments (1/2 within 30days) is not received by Supplier within such timeframe, the entire balance shall become immediately due and payable and the balance on all orders thereafter shall be due thirty (30) days after the receipt of Supplier’s invoice, unless otherwise agreed to in writing by Supplier. Invoices shall be issued no sooner than the date of Product delivery. Distributor shall have no right of deduction or offset of any amounts owed to Supplier hereunder for any reason. The Product Costs and Sample Costs do not include shipping, handling, insurance, taxes or duties, all of which shall be the sole obligation of Distributor Any amounts not paid when due are subject to a 1.5% per month finance.
3. Delivery and Title .
(a) Preparation for Shipment; Lead Time . All Products shall be handled, packaged, and shipped as required by applicable laws, rules, and regulations. They shall be suitably packed for shipment in containers adequate to insure safe arrival of the Products at Distributor’s designated delivery destination, marked for shipment to the address specified in Distributor’s acquisition order or such other address as Distributor may specify in writing. Supplier shall mark all containers with necessary shipping and handling information, acquisition order numbers and date of shipment. An itemized packing list shall accompany each shipment. Distributor will give Supplier an acquisition order no less than sixty (60) days prior to the date on which the delivery is requested.
(b) Shipping Terms . All Products will be shipped either Ex Works (Incoterms 2010) Supplier’s point of shipment, Freight Prepaid & Charged to Supplier or Freight Collect (at Supplier’s sole discretion). Buyer shall be responsible for the costs of shipping.
(c) Title and Risk of Loss . Risk of loss of Products shipped by Supplier hereunder shall pass to Distributor upon receipt of the Products by Distributor at the delivery location for Distributor. Supplier will be solely responsible for any insurance on loss of Product during shipment to Distributor’s facilities.
(d) Inspection and Returns for Damage or Defect . Distributor will inspect each shipment of Products for obvious damage when Distributor receives the shipment. If Distributor finds an obviously damaged or defective Product, it will provide written notice to Supplier, describe the damage or defect and request a return authorization form. The notice and request for return must be provided within ten (10) days following receipt of the shipment (the day of receipt will not be counted as one of the days for this purpose) or the Products will be deemed accepted by Distributor. If there is no notice or request for return by Distributor during the ten-day period, or the damage or defect is due to the act or omission of Distributor, then Supplier will have no obligation to replace the Product and Distributor will pay for the Products. Supplier will pay for the shipment and insurance for the authorized return of Products. The only remedy available to Distributor for an obviously damaged or defective Product is to receive a replacement of such
Exhibit 10.13
defective Product . Distributor will not receive any refunds of amounts paid or credits toward future payments to Supplier.
4. Limited Warranty .
(a) Warranty Terms . Supplier shall warrant the Products pursuant to the form of Limited Warranty generally provided in connection with the distribution of the Products by Supplier in effect at the time of delivery of such Products. A copy of the Limited Warranty in effect as of the Effective Date is attached as Schedule 4. Supplier shall have the right to make revisions to the Limited Warranty from time to time upon prior written notice to Distributor, provided that any such revision shall be applicable only to Products that are supplied to Distributor after the effective date of such revision.
(b) Warranty From Distributor to End-Users . Distributor shall not pass through Supplier’s Limited Warranty to End Users of the Products. Distributor shall be free to establish the terms of any warranty it wishes to extend to its End User customers. Supplier’s Limited Warranty hereunder shall not be construed to give a right of action based on such warranty to End User customers of Distributor.
(c) Limitations . The Limited Warranty will be void and Supplier will not have any obligation to honor the Limited Warranty, or have liability for any breach of Warranty to Distributor, if Products are used for any use outside the Field, as defined below, or if Distributor: (i) alters, changes or damages the Products or any component of the Products; (ii) distributes, advertises or promotes the Products for uses outside the Field; (iii) uses Marketing Materials, as defined below, not approved by Supplier as provided in Section 6(b), (iv) misrepresents the nature of the Products, their intended uses or scope of the Field, components, or makes any statement, representation or warranty to any person or entity regarding the Products that breaches this Agreement; or (iv) distributes a Product for which it has actual knowledge of defect or damage.
(d) Warranty Returns . All Products in breach of the Limited Warranty, shall be, at Supplier’s option and after a reasonable opportunity for Supplier to inspect such Products, destroyed or returned to Supplier at Supplier’s expense. For any Products returned to Supplier, Distributor will comply with Supplier’s then current Return Materials Authorization process.
(e) Disclaimer . EXCEPT FOR THE EXPRESS WARRANTIES CONTAINED IN THIS SECTION 4 AND SECTION 9, SUPPLIER MAKES NO OTHER WARRANTIES OR REPRESENTATIONS WITH RESPECT TO THE PRODUCTS, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, TITLE OR ARISING OUT OF A COURSE OF DEALING, CUSTOM OR TRADE. ALL SUCH OTHER WARRANTIES ARE HEREBY DISCLAIMED.
5. Regulatory Approvals . Supplier shall be solely responsible for maintaining regulatory clearances for Products in the U.S.; provided, however , that Distributor will be responsible for any of Supplier’s costs in providing any modifications to existing regulatory clearances as a result of applying Distributor’s Private Label Brands to the Products as required hereunder. Supplier will supply proof of such market clearances for the U.S. to Distributor. Distributor shall be solely responsible for setting reimbursement fees with health regulatory authorities, and for billing and for collecting fees associated with distribution of the Private Label Branded Products. Supplier agrees to supply to Distributor all reasonable information and documentation necessary to obtain such reimbursement approval. All costs for obtaining the reimbursement approvals for the Private Label Branded Products are the Distributor’s financial responsibility.
6. Distribution and Marketing by Distributor .
(a) Marketing Rights . Distributor shall have the right to distribute the Products under its Private Label Brand, either directly or, subject to the provisions of Section 6(c), through independent representatives, distributors or sub-distributors, anywhere in the United States of America (the “ Territory ”), to hospitals, surgery centers or clinics at which surgery using the Implants is conducted, or to any licensed surgeons or other licensed healthcare professionals who perform such surgery (“ End Users ”). Distributor shall distribute the Products to its End Users at prices and on terms Distributor determines in the exercise of its sole discretion. The Products shall be sold strictly for use in surgical applications as approved or cleared by the U.S. Food and Drug Administration (“ FDA ”) or other applicable regulatory authorities and consistent with the approved or cleared indications for use (the “ Field ”). The Products shall not be sold for use outside of the Field. Distributor acknowledges that the FDA or other applicable regulatory authorities may narrow the Field at any time.
Exhibit 10.13
(b) Promotion and Marketing . Distributor will market, promote, advertise and distribute the Products in the Field with the goal of maximizing distribution of the Products . All marketing, advertising, promotion and education documentation (including training materials) used by Distributor (“ Marketing Materials ”) shall be technically accurate and shall comply with the requirements of this Agreement. Before Distributor uses any Marketing Materials, Distributor shall give copies to Supplier (at least ten (10) business days before anticipated use) for the approval of Supplier solely for technical accuracy of the Marketing Materials. Supplier shall not withhold its consent unreasonably. If Supplier finds that any part of the Marketing Materials does not comply with the requirements of this Agreement, it shall be reasonable for Supplier to withhold its consent.
(c) Distributor Representatives . Distributor has the right to use independent representatives and distributors for the promotion, marketing, advertising and distribution of the Products. Distributor shall ensure that such representatives and distributors comply with this Agreement. Distributor has full responsibility for the actions and omissions of its representatives and distributors and an action or omission by a representative that would constitute a material breach of this Agreement by the Distributor will be treated as a material breach of this Agreement by Distributor and Supplier will have all of the remedies against Distributor set out in this Agreement for a material breach by Distributor.
(d) Market Diligence . If Distributor becomes aware of any use of the Products other than by End Users or outside the Field, then Distributor shall: (a) notify Supplier within five (5) business days; (b) if the use outside of Field is by customers of Distributor, take commercially reasonable actions to end the unapproved use; or (c) cooperate with and assist Supplier in any legal action that Supplier may decide to bring.
(e) Distributor Conduct . Distributor will conduct all of its activities pursuant to this Agreement in compliance with all applicable laws, including, without limitation, all FDA requirements, the United States Federal Anti-Kickback Statute, the Health Insurance Portability and Accountability Act, as amended, and, if applicable, the United States Foreign Corrupt Practices Act of 1977, as amended. In addition, Distributor will not:
(i) modify, change or alter the Products or any Product labeling.
(ii) promote, advertise, sell or distribute the Products for any use other than in the Field.
(iii) make any representations, statements or warranties regarding the Products that are inconsistent with any applicable regulatory approvals.
(iv) violate any policies and procedures required by any End User or other customer of Distributor.
(v) use any of the Products to conduct any clinical study or in connection with a submission to the FDA, to obtain a CE Mark approval or for other regulatory purposes without Supplier’s prior written consent.
(f) Audit Right . At any time during the Term, upon ten (10) days prior written notice, Supplier will have the right to enter and have reasonable access to the premises and facilities of Distributor during normal business hours to verify Distributor’s compliance with this Agreement, including a physical inspection and/or a quality review directly relating to any FDA tracking. No charge will be made for such visits
(g) Retained Rights . This Agreement does not grant Distributor any exclusive rights. Without limiting any other rights of Supplier, Supplier has and retains the right to: distribute the Products anywhere in the world; license the Products technology to any person or entity; enter into other distribution agreements for the Products under Supplier’s trademarks or under a private label name other than Distributor’s Private Label Brands.
7. Reports and Recalls .
(a) Product Tracing . Distributor is responsible for tracing the Implants sold under its Private Label Brand to all End Users of such Implants. With respect to any Products provided to End Users on a consignment basis, Distributor shall maintain the records necessary for tracing such Products to the consignee. Distributor shall not be required to provide Supplier with any information acquired pursuant to this Section 7(a) except to the extent required by law or to facilitate coordination of any Product recall or field actions.
(b) Problem/Complaint Notice . Distributor will notify Supplier in writing of any complaint, suspected adverse reaction (incident or near-incidents), outcome or claim related to any Product (a “ Product Complaint ”) within forty-eight (48) hours after Distributor becomes aware of the Product Complaint. Supplier shall provide Distributor with a phone number to use for such notification. Supplier will investigate the facts and circumstances of the Product Complaint in accordance with its internal procedures and applicable law and will file any reports required in connection with the Product Complaint with the applicable governmental agencies with jurisdiction, if any, over the Product
Exhibit 10.13
Complaint. Distributor will provide Supplier with all information it is able to obtain using commercially reasonable efforts regarding the Product Complaint including, the Product shipped, the End User, the history of use of the Product by the End User, and any other information reasonably available and necessary for the investigation by Supplier or the completion of any governmental filing. Distributor will fully cooperate with Supplier in investigating the Product Complaint. I f necessary in order to fully investigate the Product Complaint, Distributor will make its employees and representatives reasonably available for interviews concerning the Product Complaint by Supplier or its counsel and/or representatives following the reasonable request of Supplier.
(c) Sharing of Information . Each party shall provide the other with prompt notice if it is contacted by a Competent Authority regarding any Product Complaints. Supplier shall also notify Distributor of any Product recall or field action or any order for a recall by a Competent Authority. For purposes of this Section 7(c), “ Competent Authority ” shall mean any federal, state, or local governmental authority or regulatory body, or any quasi-governmental or private body asserting, exercising or empowered to assert or exercise any regulatory authority thereunder and any entity or organization directly or indirectly owned by and subject to the control of any of the foregoing.
(d) Recalls . Distributor acknowledges and agrees that it is Supplier’s exclusive right to issue field actions, safety alerts, advisory notices or similar remedial actions with respect to the Products. Supplier shall be solely responsible for the costs, decision and execution for a Product recall or field action. Distributor shall fully cooperate and reasonably assist Supplier in the event of a recall. All information obtained by Distributor will be provided as soon as reasonably possible to Supplier.
(i) If any, or all, of the Products are recalled other than as a result of a wrongful act or omission of Distributor, then:
(1) Supplier will pay for all shipping and insurance to return any of the affected Products to Supplier.
(2) Within 90 days after the recall, Supplier will replace the recalled Product(s). The only obligations of Supplier for recalled Product(s) are to: (A) replace the recalled Product(s) and pay for destroying the recalled Products and the shipping and insurance for retrieving the recalled Product(s) and shipping replacements; or (B) the obligation specified in Subsection (c) (i) (3), below.
(3) Following a recall, if Supplier cannot replace the recalled Products or is not able to provide Distributor with replacement Products for more than 90 days, then Supplier will pay to Distributor: (A) all Product Costs paid to Supplier by Distributor for the recalled Products that are not replaced; and (B) all shipping and insurance paid by Distributor for the recalled Products.
(ii) If any, or all, of the Products are recalled as a result of the act or omission of Distributor, then:
(1) Distributor will pay for all shipping and insurance to return the relevant Product to Supplier.
(2) If Distributor orders Product to replace the recalled Product, then such orders will not be part of the Minimum Acquisition Commitment. The orders will be considered additional orders and will be filled by Supplier consistent with its business commitments and requirements. All shipping and insurance for the orders will be paid by Distributor.
8. Indemnities and Insurance .
(a) Indemnification by Supplier . Supplier shall indemnify Distributor, its parent, subsidiaries and affiliates, and its and their respective officers, directors, agents and employees, and their successors and assigns (collectively, the “ Distributor Indemnitees ”), from and against any and all third party claims, demands or actions (each, a “ Claim ”), and indemnify and hold harmless any Distributor Indemnitee from and against all resulting liabilities, fees, suits, causes of action, damages, penalties, recoveries and deficiencies, costs and expenses (including, without limitation, attorneys’ fees) (collectively, “ Damages ”) which arise out of or relate to (i) any breach of any representation or warranty under Section 9(a), (ii) any Claims for product liability arising out of a defect in the manufacture or supply of the Products by Supplier, (iii) any breach of confidentiality under Section 10, or (iv) any Claim that a Product, when used or distributed as provided for by this Agreement infringes any patent of a third party issued in the Territory; provided that , in connection with any Claims described in (ii) or (iv) hereof, the alleged defect
Exhibit 10.13
or infringement: ( A ) existed at the time the Product was shipped by Supplier ; and ( B ) is not attributable to any unauthorized use or modification regarding such Product by Distributor or any third party; and provided further that, such indemnity shall not apply to the extent that it is shown that the Damages were the result of : ( C ) a breach by Distributor of a representation, warranty, or covenant of this Agreement including, without limitation, any use of the Products in breach of this Agreement; or ( D ) the negligence or willful misconduct of Distributor or any Distributor I ndemnitee or subdistributor .
(b) Indemnification by Distributor . Distributor shall indemnify, defend and hold harmless Supplier, its parent, subsidiaries and affiliates, and its and their respective officers, directors, agents and employees, and their successors and assigns (collectively, the “ Supplier Indemnitees ”), from and against any and all Damages which arise out of or relate to (i) any breach of any representation or warranty under Section 9(b), (ii) any breach of Distributor’s obligations under Section 6(e) or Section 10, (iii) the negligence or willful misconduct of Distributor or any subdistributor, Distributor Indemnitee or subcontractor of Distributor or (iv) any claim that a Product, when used or distributed in a manner instructed or suggested by Distributor that is other than as provided for by this Agreement, violates any regulatory approval related to the Product as a result of such use or distribution or infringes any intellectual property rights of Supplier or a third party as a result of such use or distribution; provided, that such indemnity shall not apply to the extent that it is shown that the Damage was the result of (A) a breach by Supplier of a representation, warranty, or covenant of this Agreement; or (B) the negligence or willful misconduct of Supplier or any Supplier Indemnitee.
(c) Indemnification Procedures . Any entity entitled to indemnification under this Section 8 shall give written notice to the indemnifying party of any Claims that may be subject to indemnification, promptly after learning of such Claim. Within a reasonable time after receiving such notice, the indemnifying party may assume the defense of such Claims with counsel reasonably satisfactory to the indemnified party. Subject to the terms of the parties’ respective professional liability and malpractice insurance policies, the indemnified party shall cooperate with the indemnifying party in such defense at the indemnifying party’s expense. The indemnified party may, at its option and expense, be represented by counsel of its choice in any action or proceeding with respect to such Claim. The indemnifying party shall not be liable for any litigation costs or expenses incurred by the indemnified party without the indemnifying party’s written consent, such consent not to be unreasonably withheld. The indemnifying party shall not settle any such Claim if such settlement (i) does not fully and unconditionally release the indemnified party from all liability relating thereto or (ii) adversely impacts the rights granted to the indemnified party under this Agreement, unless the indemnified party otherwise agrees in writing.
(d) Insurance . Supplier represents and warrants that it is currently insured and covenants that at all times during the term of this Agreement it will maintain a comprehensive general liability insurance policy (including products liability coverage and payment of attorney’s fees coverage) with a financially sound and reputable insurer which is sufficient to adequately protect against the risks associated with its activities under this Agreement, including the risks which might possibly arise in connection with the transactions contemplated by this Agreement, and including without limitation, products liability insurance, with minimum coverage amounts of $5,000,000 per occurrence and per year in the aggregate. Supplier agrees to provide Distributor a certificate of such insurance upon request. Supplier shall have Distributor named as an additional insured beneficiary. Distributor represents and warrants that it is currently insured and covenants that at all times during the term of this Agreement it will maintain a comprehensive general liability insurance policy (including products liability coverage and payment of attorney’s fees coverage) with a financially sound and reputable insurer which is sufficient to adequately protect against the risks associated with its ongoing business, including the risks which might possibly arise in connection with the transactions contemplated by this Agreement, and including without limitation, products liability insurance, with minimum coverage amounts of at least $5,000,000 per occurrence and per year in the aggregate (or any greater amount required by the applicable End User) . Distributor agrees to provide Supplier a certificate of such insurance upon request. Distributor shall have Supplier named as an additional insured beneficiary.
(e) LIMITATION OF LIABILITY . In no event shall EITHER PARTY be liable to THE OTHER PARTY or any other person or entity for special, incidental, consequential, OR PUNITIVE damages (including, but not limited to, loss of profits, loss of data or loss of use damages) arising out of the manufacture, sale or supply of the Products, even if SUCH OTHER PARTY has been advised of the possibility of such damages or losses . SUPPLIER’S TOTAL LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT WILL NOT EXCEED THE AGGREGATE AMOUNTS PAID BY DISTRIBUTOR TO SUPPLIER UNDER THIS AGREEMENT DURING THE PRECEDING TWELVE (12) MONTHS. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 8(e) SHALL LIMIT EITHER PARTY’S INDEMNIFICATION RIGHTS OR OBLIGATIONS UNDER SECTION 8(a) OR 8(b) OR THE DAMAGES AVAILABLE FOR EITHER PARTY’S BREACH OF SECTION 10.
Exhibit 10.13
9. Representations and Warranties .
(a) Supplier . Supplier represents and warrants the following, each of which representation and warranty is true on the date of this Agreement and will be true until the end of the Term, and each of which is material and is being relied on by Distributor: (i) it is a corporation, validly organized and existing and in good standing under the laws of the State of New Jersey and is duly qualified or licensed as a foreign corporation to do business, and is in good standing, in each jurisdiction where the character of the assets or properties owned, leased or operated by it or the nature of its activities makes such qualification or licensing necessary; (ii) it has full power and lawful authority to execute, deliver, and perform under this Agreement; (iii) its execution and performance of this Agreement is not contrary to, or prohibited by, any laws, or agreements to which it is a party or by which it is bound or by any arbitration award, judgment or court order by which it is bound; (iv) it is in possession of all franchises, grants, authorizations, licenses, registrations, permits, easements, consents, waivers, qualifications, certificates, orders and approvals, necessary to own, lease and operate its assets and properties and to carry on its business as it is now being conducted; (v) this Agreement, and any document executed pursuant to this Agreement, are valid obligations of Supplier enforceable in accordance with their terms; (vi) it has taken all corporate action necessary in order to cause the execution and performance of this Agreement; (vii) it has the right to manufacture and sell to Distributor for distribution and use in the Field the Products; and (viii) Supplier has and, during the Term shall maintain, FDA clearances for the Products.
(b) Distributor . Distributor represents and warrants the following, each of which representation and warranty is true on the date of this Agreement and will be true until the end of the Term, and each of which is material and is being relied on by Supplier: (i) it is a limited liability company, validly organized and existing and in good standing under the laws of the State of Texas and is duly qualified or licensed as a foreign corporation to do business, and is in good standing, in each jurisdiction where the character of the assets or properties owned, leased or operated by it or the nature of its activities makes such qualification or licensing necessary, (ii) it has full power and lawful authority to execute, deliver, and perform under this Agreement; (iii) its execution and performance of this Agreement is not contrary to, or prohibited by, any laws, or agreements to which it is a party or by which it is bound or by any arbitration award, judgment or court order by which it is bound; (iv) this Agreement, and any document executed pursuant to this Agreement, are valid obligations of Distributor enforceable in accordance with their terms; (v) it is in possession of all franchises, grants, authorizations, licenses, registrations, permits, easements, consents, waivers, qualifications, certificates, orders and approvals, necessary to own, lease and operate its assets and properties and to carry on its business as it is now being conducted; (vi) it has taken all action necessary in order to cause the execution and performance of this Agreement; (vii) it has the right to use its Private Label Brands in the marketing, promotion and distribution of the Products and (viii) that Distributor, including each employee and agent performing services under this Agreement: (A) is not under investigation by any regulatory agency, medical ethics body or other agency or authority that regulates marketing of medical devices or the medical or healthcare profession ( “Regulatory Agency” ) for debarment, discipline or disqualification or presently debarred, disciplined or is disqualified by any Regulatory Agency, (B) has not been disciplined or disqualified by any Regulatory Agency and does not have a disciplinary or disqualification hearing pending, and (C) is not currently included in the U.S. Office of Inspector General List of Excluded Individuals.
(c) No Other Representations and Warranties . Except for the representations and warranties contained in Sections 4 and 9, none of the parties has made any express or implied representation or warranty to the other regarding this Agreement and the subject matter of this Agreement.
10. Confidentiality and Proprietary Information; Non-Solicitation .
(a) Confidential Information . During the Term and for five (5) years after termination, all information designated as confidential or proprietary information, or which the other party should reasonably know is confidential, and furnished by Distributor to Supplier or any of its affiliates, or by Supplier to Distributor or any of its affiliates, during the term of this Agreement, (“ Confidential Information ”) including, without limitation, any Specification, formulation, design information, Product architecture, and information about new products provided pursuant to Section 1(h) (with respect to Supplier), quality assurance plans, marketing strategies, business plans and strategies, inventions (whether or not the subject of pending patent applications), trade secrets, know-how, cost and profit data, distribution and marketing plans, and business and financial information, shall be kept confidential by the party receiving it. The party receiving Confidential Information shall not disclose it or make use of it, except for purposes authorized by this Agreement, nor disclose any Confidential Information to any person or firm unless previously authorized in writing to do so; provided, however, that the receiving party may disclose it as necessary to responsible officers, employees and agents for the purposes of performing its obligations under this Agreement, provided that such officers and employees shall have assumed in writing obligations of confidentiality no less restrictive than those contained herein The receiving party may disclose Confidential Information as required by government and regulatory agents for the purposes of
Exhibit 10.13
performing its obligations under this Agreement, or as necessary to comply with applicable la ws or pursuant to valid court orders; provided that the receiving party gives reasonable advance written notice to the other party of such disclosure and endeavor in good faith to secure confidential treatment or seek an appropriate protective order of such information at the d isclosing p arty’s request and expense and cooperate with any efforts by the d isclosing p arty to secure confidential treatment or obtain a protective order .
(b) Exclusions . The foregoing limitations on the use and disclosure of Confidential Information shall not apply to information which:
(i) at the time of disclosure is, or thereafter lawfully becomes, part of the public domain through no fault, act or omission of the receiving party, its employees, agents or independent contractors; or
(ii) was otherwise in the receiving party’s lawful possession prior to disclosure as shown by its written records; or
(iii) is subsequently rightfully obtained by the receiving party from a third party who has the legal right to disclose it, without an obligation to keep such information confidential; or
(iv) is released from confidential status by mutual agreement of the parties.
(c) Injunctive Relief . The receiving party acknowledges and agrees that unauthorized use or disclosure of Confidential Information of the other party will cause serious, irreparable and significant harm, damage or loss to the other party which will be difficult or impossible to ascertain. Accordingly, the receiving party agrees that the other party will have, in addition to all other remedies at law or in equity, the right to seek immediate injunctive relief to enforce the receiving party’s obligations under this Agreement. All costs, including reasonable attorneys’ fees, borne by either party in the event of legal action shall be paid by the non-prevailing party.
(d) Confidentiality of Agreement . Except as required by law, Distributor and Supplier shall keep the specific terms of this Agreement, as well as any materials provided in connection herewith, strictly confidential, and shall each make all reasonable efforts to maintain such confidentiality, including restricting employees’ access to the terms of the Agreement on a “need to know” basis, limiting copies and ensuring that all employees privy to the terms of this Agreement shall undertake in writing obligations of confidentiality no less restrictive than those contained herein.
(e) Effect of Expiration or Termination . Upon expiration or termination of this Agreement for any reason, the receiving party shall promptly either deliver to the supplying party or destroy and certify such destruction (at disclosing party’s option) all reproductions, copies, extract or the like of any documents or other media containing any Confidential Information of the other party.
(f) Trademarks and Labeling . Distributor hereby grants to Supplier a limited, non-exclusive, world-wide, non-transferable, royalty-free license, with the right to sublicense, solely to use the Private Label Brands, trademarks, service marks, trade names, and logos owned by or licensed to Distributor (the “ Distributor Trademarks ”) in labeling and packaging the Products for distribution exclusively to Distributor, as directed from time to time by Distributor throughout the term of this Agreement, subject to the terms and conditions of this Agreement. Supplier hereby agrees that the Distributor Trademarks shall only be affixed to the Products or other promotional materials as directed by the Distributor and for no other uses.
(g) Non-Solicitation . During the Term and for two (2) years after termination, (i) each of Distributor and Supplier agree that it shall not (A) (other than by means of a general solicitation in a newspaper or other mass communication) directly or indirectly solicit, entice or induce or attempt to induce any employee of the other party to terminate his or her employment with the other party or in any way interfere with the relationship between the other party and any employee, or (B) hire directly or through another entity any person who was an employee of the other party during the prior six month period; and (ii) Distributor agrees not to solicit (other than by means of a general solicitation in a newspaper or other mass communication) induce or attempt to induce any of Supplier’s contractors or direct or indirect suppliers to cease doing business with Supplier or in any way interfere with the relationship between any such person and Supplier. During the Term, and for two years thereafter, Supplier and its affiliates agrees not to solicit for sales of Products on its own behalf, any individual doctor customer account of Distributor that Distributor identifies to Supplier in writing.
11. Term and Termination .
(a) Term . Unless sooner terminated in accordance with Section 11(b) below, the term of this Agreement shall commence on the Effective Date and shall terminate on the fifth anniversary hereof (the “ Initial Term ”); provided that the term shall be automatically extended for successive one (1) year periods after the fifth anniversary hereof unless
Exhibit 10.13
either party provides written notice of termination no less than thirty ( 3 0) days prior to the end of the then applicable term period (the “ Term ”).
(b) Early Termination for Cause . This Agreement may be terminated early for cause as otherwise provided in this Agreement, and as follows:
(i) By any party immediately upon written notice if the other party is subject to any proceedings under any federal or state law for the relief of debtors, including: the filing by or against such party of a voluntary or involuntary case under the federal bankruptcy law, which proceedings, if involuntary, are not dismissed within 30 days after their filing; an assignment of any portion of the property of such party for the benefit of creditors; the appointment of a receiver or trustee for any portion of the assets of such party, which appointment, if obtained ex parte , is not dismissed within 30 days thereafter; or the seizure by a sheriff, receiver, trustee in bankruptcy (or other creditors) or of any portion of the assets of such party.
(ii) By any party if the other party fails to perform or otherwise breaches any of its material obligations hereunder, by giving prior written notice of its intent to terminate and stating in detail the grounds for termination. The party receiving such notice shall have thirty (30) days from the receipt of such notice to cure such material breach, at which time this Agreement shall terminate if such material breach has not been cured. In no event, however, shall such notice of intention to terminate be deemed to waive any rights to damages or any other remedy which the party giving notice of breach may have as a consequence of such breach.
(iii) By any party immediately upon written notice to the other party if such party is prohibited from manufacturing, supplying or distributing the Products by the FDA or other regulatory body or any applicable laws.
(iv) By Supplier pursuant to Section 2(c)(ii) or immediately (with no opportunity to cure) if Distributor breaches the provisions of either Sections 6(e), 9(b)(vii), or 9(b)(viii).
(v) By Supplier if Supplier enters into an exclusive arrangement for any or all of the Products during the Term of this Agreement; provided however , Supplier agrees to provide no less than sixty (60) days written notice and continue to supply Products to Distributor hereunder unless Supplier (A) repurchases Distributor’s then-existing inventory of Products at the original sales price paid by Distributor for such Product, and (B) pays Distributor a termination fee equal to one (1) times Distributor’s 6 months trailing revenue for sale of Products to End Users in the Field and in the Territory, subject to Distributor providing documentation reasonably acceptable to Supplier of such sales.
(c) Effect of Termination . If this Agreement is terminated for any reason, (i) the parties shall be released from all further obligations, duties imposed or assumed hereunder, except as already accrued as of the termination date or as otherwise provided in this Agreement and (ii) unless otherwise required or allowed by Supplier, in its sole discretion, Distributor must accept delivery of and pay Supplier for all orders that have been accepted by Supplier but not filled or delivered as of the effective date of the termination, and all relevant provisions of this Agreement shall apply to such orders and the Products covered by such orders. Termination of this Agreement, for whatever reason, shall not affect the obligation of either party to make payments for which such party is liable prior to such termination. In the event of any termination, Distributor shall have a 6 month sell-off period during which Distributor may sell-off any of its then-remaining inventory of Products, provided, however , that the Agreement was not terminated due to a breach by Distributor. All provisions that by their nature are intended to survive the termination or expiration of this Agreement, shall survive the termination or expiration, including: 2(c)(ii), 4, 7, 8(a), 8(b), 8(c), 8(e), 10, 11, 12 and 13 (to the extent applicable).
12. Notices . All notices, requests or other communications pursuant to this Agreement shall be in writing and addressed as follows:
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If to Supplier: |
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Tyber Medical, LLC |
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83 South Commerce Way, Suite 310 Bethlehem, PA 18017 Attention: Jeff Tyber Fax: (866)889-9914 E-mail: jtyber@tybermed.com |
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With a copy to: |
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BISLaw, LLC |
Exhibit 10.13
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600 S. Cherry St. |
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Denver, CO 80246 |
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Attention: Brent Slosky Fax: (720) 457-9883 E-mail: brent@bislaw.net |
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If to Supplier: |
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_____________________, LLC Attn: Bill McLaughlin, CFO 1565 N. Central Expressway 2 nd Floor Richardson, Texas 75080 Email: bmclaughlin@surgicalservice.com |
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with a copy to: |
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Ferguson, Braswell & Fraser, PC Attn: Dustin H. Sparks 2500 Dallas Parkway Suite 600 Plano, Texas 75093 Email: dsparks@dallasbusinesslaw.com |
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Any notice to be given or to be served upon any party to this Agreement will be in writing and will be deemed to be given and received when delivered (if the notice is delivered on a day other than a business day or after 5 p.m. (local time where received) on a business day, then delivery shall be deemed to have taken place on the first business day thereafter) to the address of each party set forth in this Section 12 via courier or other means of personal service including, but not limited to, messenger service, Fedex, DHL or United Parcel Service, or if sent by facsimile (telecopier) or e-mail, when received as long as the full text of any such notice is (i) readable and (ii) is received in full prior to 5:00 p.m. (local time where received) on a business day which receipt is confirmed. If the full readable text is received following 5:00 p.m., then the notice will be deemed received at 10:00 a.m. (local time where received) on the next succeeding business day. The telecopier number for each party is set forth in this Section 12. The notice information in this Section may be changed by giving written notice of such change to the other party as provided in this Section for giving notice. However, unless and until such written notice of change is actually received, the last address or telecopier number as stated by written notice or as provided in this Agreement, if no written notice of change has been sent or received, will be deemed to continue in effect for all purposes.
13. General Provisions .
(a) Assignment . This Agreement may not be assigned or transferred by any of the parties, and no rights or obligations hereunder may be delegated or assigned, without the express written consent of the other party. Notwithstanding the foregoing, either party may assign or transfer this Agreement in its entirety in connection with an acquisition of all or substantially all of the assets or voting stock of such party or a merger or consolidation involving such party. This Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the parties. Any attempted assignment in violation of this Section 13(a) shall be null and void.
(b) Entire Agreement . This Agreement and the Schedules hereto shall constitute the entire agreement between the parties hereto and shall supersede any other agreements, whether oral or written, express or implied, as they pertain to the supply of the Products by Supplier to Distributor. All distribution shall be pursuant to the terms set forth in this Agreement. All quotations, acquisition orders, releases, authorizations, acknowledgments and invoices issued pursuant to this Agreement shall be subject to the provisions of this Agreement. The parties acknowledge that any provisions on any such quotation, acquisition order, release, acknowledgment or invoice that conflict with the terms of this Agreement shall be deemed deleted.
(c) Relationship . The relationship created by this Agreement shall be strictly that of supplier and distributor as independent contractors and no agency, partnership or joint venture shall be deemed to be created hereby. Nothing in this Agreement shall constitute one party as an agent or legal representative of any other party for any purpose whatsoever, and no party is granted no right or authority hereunder to assume or create any obligation, express or implied, or to make any representation, warranties or guarantees, on behalf of any other party.
Exhibit 10.13
(d) Waiver . A waiver by any party of a breach of any of the terms of this Agreement by the other party shall not be deemed a waiver of any subsequent breach of the terms of this Agreement. All waivers of any rights or obligations must be in writing and signed by the party granting such waiver.
(e) Release . The expiration or termination of this Agreement for any reason whatsoever shall neither be deemed a release, nor shall it relieve any party from any obligation under this Agreement which may have accrued prior thereto.
(f) Specific Performance . The parties intend that the following obligations and provisions of this Agreement be enforceable by specific performance and other equitable relief: (i) the confidentiality provisions of Section 10 and (ii) provisions relating to the protection of intellectual property rights (collectively the “ Specific Performance Provisions ”). The parties acknowledge that a party seeking to enforce the Specific Performance Provisions will not have an adequate remedy at law for the breach of the Specific Performance Provisions, damages alone will not be adequate for a breach of the Specific Performance Provisions, and such party will suffer irreparable harm as a result of such breach. Such party shall have the right to enforce the Specific Performance Provisions through specific enforcement and all equitable remedies, including, but not limited to, mandatory and prohibitory injunctions.
(g) Governing Law and Jurisdiction . This Agreement shall be governed by, and construed and interpreted in accordance with, the laws of the State of New Jersey as a contract made between two parties made in New Jersey to be performed and consummated in New Jersey. In the event of any dispute, the Chief Executive Officer or President of each party shall meet and discuss the dispute and attempt to resolve the dispute in good faith. The sole and exclusive venue for any action brought under this Agreement shall be in a federal or state court in Newark, New Jersey, and the parties agree that such courts shall have jurisdiction. Unless laws or rules strictly require different service of process, service of process may be made by certified mail return receipt requested sent to the address shown in Section 12.
(h) Severability . If any provision of this Agreement is deemed invalid or unenforceable by a court of competent jurisdiction, such invalidity or enforceability shall not affect or limit the validity or enforceability of any other provision hereof.
(i) Force Majeure . No party shall be held responsible for any delay or failure in performance of any part of this Agreement to the extent such delay or failure is caused by fire, flood, strike, civil, governmental or military authority, or act of God. When a party’s delay or nonperformance continues for a period of at least ninety (90) days due to any such event, the other party may terminate this Agreement.
(j) Headings . All headings and captions are inserted for convenience of reference only and shall not affect the meaning or interpretation of any provision hereof.
(k) Counterparts . This Agreement may be executed in any number of counterparts, each of which once so executed and delivered shall be deemed an original, but all of which shall constitute but one and the same Agreement.
(l) Amendment . No amendment or modification relating in any manner to this Agreement shall be effective unless executed in writing and signed by the parties.
(m) Attorneys’ Fees . In the event of any action or claim between the parties hereto relating to the Agreement or the breach hereof, the prevailing party in such action claim shall be entitled to recover from such other party the costs and expenses of such prevailing party, including reasonable fees of attorneys and other advisors, incurred in taking or defending such action or claim.
(n) No Third Party Beneficiaries . Except in connection with Sections 8(a) and 8(b), which are for the benefit of those identified therein, nothing herein is intended or shall be construed to confer upon any person or entity, other than the parties hereto and their respective successors and assigns, any rights, remedies or other benefits under or by reason of this Agreement.
(o) Remedies Not Exclusive . No remedy conferred by any of the provisions of this Agreement is intended to be exclusive of any other remedy, and each and every remedy will be cumulative and will be in addition to every other remedy given hereunder or now or hereafter existing at law or in equity or by statute or otherwise. The election of any one or more remedies will not constitute a waiver of the right to pursue other available remedies.
[ Signature Page Follows ]
Exhibit 10.13
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
Exhibit 10.13
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Schedule 1 |
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Products |
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Schedule 2 |
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Private Label Brands |
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Schedule 3 |
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Prices for Products |
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Schedule 4 |
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Limited Warranty |
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Exhibit 10.13
Products
Tyber Medical Headless & Headed Screw Systems
Exhibit 10.13
Private Label Brands
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CPM Medical |
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Small Cannulated Screw System Large Cannulate Screw System |
Exhibit 10.13
Schedule 3
Prices for Products
Implants : According to the following per unit (“$47.50”) for implants; Minimum order is 50 units. Pricing for less than 50 units or more than 3 lots will require a new price quote.
Instruments : A standard instrument set consisting of:
Small $4,702.12 |
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Large $5,676.68 |
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Individual instruments will be quoted at time of purchase based on quantity and availability.
Samples : Sample/Demo implants and instruments may be purchased at a mutually agreed upon price.
Any special instruments or customization will require a quote from Supplier.
Shipping, as described herein, and applicable tax if any to be added to the final invoice for all transactions as appropriate.
Exhibit 10.13
Schedule 4
Limited Warranty
The form of Limited Warranty in effect as of the Effective Date is as follows:
EACH Product is warranted to be free from defects in workmanship and materials at the time of delivery for a period of 3 months after delivery of each Product. This warranty is limited to the replacement of the Product. NO OTHER WARRANTY IS GIVEN BY SUPPLIER and no representation, warranty or affirmation of any employee, contractor, agent, detailer, distributor or any other person actually or purporting to represent Supplier, by word or action, will constitute a warranty and such word or action does not, and will not, expand or change the express warranty given in this Limited Warranty. SUPPLIER EXPRESSLY DISCLAIMS ANY OTHER EXPRESS OR IMPLIED WARRANTY OF ANY KIND, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING BY LAW, CUSTOM, CONDUCT, USAGE OR TRADE.
Exhibit 10.14
Net Lease for Entire Building
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1. |
Names. This lease is made by 1565 N. Central Expressway, LP , Landlord, and CPM Medical Consultants, LLC, Tenant. |
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2. Premises Being Leased. Landlord is leasing to Tenant and Tenant is leasing from Landlord the following premises:
1565 N. Central Expressway, 2nd Floor, Richardson, TX 75080
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3. |
Term of Lease. This lease begins on January 1, 2013, and ends on December 31, 2017. |
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4. Rent. Tenant will pay rent in advance on the day of each month. Tenant's first rent payment will be on January I, 2013, in the an1ount of $10,000.00 . Tenant will pay rent of $10,000.00 per month thereafter.
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[X] |
Tenant will pay this rental amount for the entire term of the lease. |
[ ] Rent will increase each year, on the anniversary of the starting date in Paragraph 3, as follows: - - - - - - -
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5. |
Option to Extend Lease |
[X] First Option. Landlord grants Tenant the option to extend this lease for an additional 5 years. To exercise this option, Tenant must give Landlord written notice on or before October 31, 2017 . Tenant may exercise this option only if Tenant is in substantial compliance with the terms of this lease. Tenant will lease the premises on the same terms as in this lease except as follows: N/A .
[ ] Second Option. If Tenant exercises the option granted above, Tenant will then have the option to extend this lease for years beyond the first option period. To exercise this option, Tenant must give Landlord written notice on or before . Tenant may exercise this option only if Tenant is in substantial compliance with the terms of this lease. Tenant will lease the premises on
the same terms as in this lease except as follows: .
Exhibit 10.14
Net Lease for Entire Building Page 1 of 7
Exhibit 10.14
6. Securit y Deposit. Tenant has deposited $ 0 with Landlord as securit y for Tenant's performance of this lease. Landlord will refund the full security deposit to Tenant within 14 days following the end of the lease if Tenant returns the premises to Landlord in good condition (except for reasonable wear and tear) and Tenant has paid Landlord all sums due under this lease. Otherwise, Landlord may deduct any amounts required to place the premises in good condition and to pay for any money owed to Landlord under the lease.
7 . Improvements by Landlord
[ J Before the lease te1m begins, Landlord (at Landlord's expense) will make the
[X] Tenant accepts the premises in "as is" condition. Landlord need not provide any repairs or improvements before the lease term begins.
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8. |
Improvements by Tenant. Tenant may make alterations and improvements to the premises after obtaining the Landlord's written consent. At any time before this lease ends, Tenant may remove any of Tenant's alterations and improvements, as long as Tenant repairs any damage caused by attaching the items to or removing them from the premises. |
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9. Tenant's Use of Premises. Tenant will use the premises for the following business purposes: office space . Tenant may also use the premises for purposes reasonably related to the main use.
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10. |
L a ndlor d's Representations. Landlord represents that: |
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A. |
At the beginning of the lease term, the premises will be properly zoned for Tenant's stated use and will be in compliance with all applicable laws and regulations. |
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B. The premises have not been used for the storage or disposal of any toxic or hazardous substance and Landlord has received no notice from any governmental authority concerning removal of any toxic or hazardous substance from the prope1iy.
i
I
Utilities and Services. Tenant will pay for all utilities and services, including water,
I
electricity, and gas, including the electricity or gas needed for heating and air
conditioning.
Exhibit 10.14
Exhibit 10.14
A. Tenant will maintain and make all necessary repairs to: (1) the roof, structural components, exterior walls, and interior walls of the premises, and (2) the plumbing, electrical, heating, ventilating, and air-conditioning systems.
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B. |
Tenant will clean and maintain (including snow removal) the parking areas, yards, common areas, and exterior of the premises so that the premises will be kept in a safe and attractive condition. |
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13.Insurance
A. Tenant will carry fire and extended coverage insurance on the building in the amount of at least $1,375,000; this insurance will include Landlord as m1 insured p arty.
B. Tenant will carry public liability insurance, which will include Landlord as an insured party. The public liability coverage for personal injury will be in at least the following amounts:
&> $6,000,000 per occurrence
ei $6,000,000 in any one year
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C. |
Landlord and Tenant release each other from any liability to the other for any property loss, property damage, or personal injury to the extent covered by insurance carried by the party suffering the loss, damage, or injury. |
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D. Tenant will give Landlord a copy of all insurance policies that this lease requires Tenant to obtain.
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14. |
Taxes |
A. Tenant will pay all real property truces levied mid assessed against the premises during the term of this lease.
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B. |
Tenant will pay all personal property taxes levied and assessed against Tenant's personal property. |
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15. |
Subletting and Assignment. Tenant will not assign this lease or sublet any part of |
Exhibit 10.14
Net Lease for Entire Building Page 3 of 7
Exhibit 10.14
the premises without the written consent of Landlord. Landlord will not unreasonably withhold such consent.
16. Notice of Default. Before starting a legal action to recover possession of the premises based on Tenant's default, Landlord will notify Tenant in writing of the default. Landlord will take legal action only if Tenant does not correct the default within ten days after written notice is given or mailed to Tenant.
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17. |
Quiet Enjoyment . As long as Tenant is not in default under the te1ms of this lease, Tenant will have the right to occupy the premises peacefully and without interference. |
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18. Eminent Domain. This lease will become void if any part of the leased premises or the building in which the leased premises are located is taken by eminent domain. Tenant has the right to receive and keep any amount of money that the agency taking the premises by eminent domain pays for the value of Tenant's lease, its loss of business, and for moving and relocation expenses.
19. Holding Over. If Tenant remains in possession after this lease ends, the continuing tenancy will be from month to month.
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20. |
Disputes |
[ ] Litigation. If a dispute arises, either party may take the matter to court.
[X] Mediation and Possible Litigation. If a dispute arises, the parties will try in good faith to settle it through mediation conducted by
(] _
[X] a mediator to be mutually selected.
The parties will share the costs of the mediator equally. Each party will cooperate fully and fairly with the mediator and will attempt to reach a mutually satisfactory compromise to the dispute. If the dispute is not resolved within 30 days after it is referred to the mediator, either party may take the matter to court.
[X] Mediation and Possible Arbitration. If a dispute arises, the parties will try in good faith to settle it through mediation conducted by
[] _
Net Lease for Entire Building Page 4 of 7
Exhibit 10.14
[X] a mediator to be mutually selected.
The parties will share the costs of the mediator equally. Each party will cooperate fully and fairly with the mediator and will attempt to reach a mutually satisfactory compromise to the dispute. If the dispute is not resolved within 30 days after it is referred to the mediator, it will be arbitrated by
[] _ _ _ _ _
[X] an arbitrator to be mutually selected.
Judgment on the arbitration award may be entered in any court that has jurisdiction over the matter. Costs of arbitration, including lawyers' fees, will be allocated by the arbitrator.
Landlord need not participate in mediation or arbitration of a dispute unless Tenant has paid the rent called for by this lease or has placed any unpaid rent in escrow with an agreed-upon mediator or arbitrator.
[X] Attorneys' Fees. If either party brings a legal action arising out of a dispute over this agreement, the losing party will reimburse the prevailing party for all reasonable costs and attorneys' fees incurred by the prevailing party in the lawsuit.
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21. |
Additional Agreements. Landlord and Tenant additionally agree that |
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22. |
Entire Agreement. This is the entire agreement between the parties. It replaces and |
supersedes any and all oral agreements between the parties, as well as any prior writings.
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23. |
Successors and Assignees. This lease binds and benefits the heirs, successors, and assignees of the parties. |
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24. |
Notices. All notices must be in writing. A notice may be delivered to a party at the address that follows a party's signature or to a new address that a party designates in writing. A notice may be delivered: |
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(1) |
in person |
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(2) |
by certified mail, or |
Net Lease for Entire Building Page 5 of 7
Exhibit 10.14
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(3) |
by overnight courier. |
25. Governing Law. This lease will be governed by and construed in accordance with the laws of the state of Texas .
26. Counterparts. This lease may be signed by the parties in different counterparts and the signature pages combined will create a document binding on all parties.
27. Modification. This lease may be modified only by a written agreement signed by all the parties.
28. Waiver. If one party waives any term or provision of this lease at any time, that waiver will only be effective for the specific instance and specific purpose for which the waiver was given. If either party fails to exercise or delays exercising any of its rights or remedies under this lease, that party retains the right to enforce that term or provision at a later time.
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29. |
Severability. If any court determines that any provision of this lease is invalid or unenforceable, any invalidity or unenforceability will affect only that provision and will not make any other provision of this lease invalid or unenforceable and shall be modified, amended, or limited only to the extent necessary to render it valid and enforceable. |
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Landlord
Name of business: 1565 N. Central Expressway, LP
a Limited Partnership
By: And By:
Dated: 1/1/2013 Dated: 1/1/2013
Address: 1565 N. Central Expressway, 2nd Floor, Richardson, TX 75080
Exhibit 10.14
Net Lease for Entire Building Pa ge 6 of 7
Exhibit 10.14
Name of business: CPM Medical Consultants, LLC a Limited Liability Corporation
By: Dated: 1/1/2013
Printed name: Mark W. Brooks Title: President & CEO
Address: 1565 N. Central Expressway, 2nd Floor, Richardson, TX 75080
[ ] Guarantor
By signing this lease, I personally guarantee the perfom1ance of all financial obligations of under this lease.
By:
Dated:
Printed name:
Address:
Exhibit 10.14
Net Lease for Entire Building Page 7 of 7
Exhibit 10.19
Professional Employer Organization Client Service Agreement
This Professional Employer Organization ("PEO " ) Client Service Agreement (the " Agreement " ), dated as of January 1, 2015 (the "Effective Date"), is by and between AmBio Staffing, LLC , a Texas limited liability company, with offices located at 1565 North Central Expressway, Suite 300, Richardson, TX 75080 its successors and assigns (the "PEO Provider") and CPM Medical Consultants, LLC , a Texas limited liability company, with offices located at 1565 North Central Expressway, Suite 200, Richardson, TX, 75080 (the "Client") .
1. Relationship of the Parties ; Services . The parties agree to enter into an arrangement for PEO Provider to provide human resources-related services to Client as a co-employer of Client's employees. For purposes of providing services under this arrangement, PEO Provider is designated as the Administrative Employer and agrees that it is a co-employer for purposes of carrying out the responsibilities described in Section 2 of this Agreement (hereafter "Services"). Client is designated as the Worksite Employer and agrees that it is a co-employer for purposes of carrying out the responsibilities described in Section 3 of this Agreement. Client's employees are referred to as Work Site Employees (WSEs) throughout this Agreement.
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2. |
Rights and Responsibilities of PEO Provider. |
2.1 |
PEO Provider assumes full responsibility, as the Administrative Employer of WSEs, for the duties described in this Section 2 . |
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2.2 Payment of wages, as reported by Client, through PEO Provider's payroll, including the following from which PEO Provider will make all required deductions and withholdings under applicable federal, state and local laws:
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(a) |
Salary or other Base Pay; |
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(b) |
Commissions ; |
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(c) |
Bonuses ; |
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(d) |
Overtime pay; |
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(e) |
Vacation pay ; |
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(f) |
Sick time pay ; |
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(g) |
Paid time off ; |
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(h) |
Paid leaves of absence; and |
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(i) |
Severance. |
2.3 Reporting and remitting payroll taxes, in compliance with all federal and state tax requirements on payroll wages paid under this Agreement.
2.4 Providing and administering health and welfare benefits through PEO Provider-sponsored plans, in compliance with applicable federal and state laws, and subject to eligibility requirements. These employee benefits are described on the attached Employee Benefits Addendum and include:
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(a) |
Medical; |
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(b) |
Dental; |
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(c) |
Vision; |
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(d) |
Health Flexible Spending Accounts ; |
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(e) |
Group Life ; |
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(f) |
Voluntary Life ; and |
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(g) |
Disability Insurance . |
2.5 Compliance with requirements of the Affordable Care Act (ACA) (that is, the Patient Protection and
Exhibit 10.19
Affordable Care Act (PPACA) , as amended by the Health Care and Education Reconciliation Act of 2010 (HCERA)), as applicable .
Exhibit 10.19
2.6 Compliance with requirements of the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), the Uniformed Services Employment and Reemployment Rights Act of 1994 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
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2.7 |
Providing a Section 401(k) plan or other retirement plan if and when the Client requests. |
2.8 |
Providing workers compensation insurance coverage that covers the WSEs, as well as processing and defending all workers compensation claims. |
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2.9 |
Processing and defending unemployment claims. |
2.10 |
Aggregate Client employee-related policies for the purpose of developing the basis of an Employee Handbook, that comply with federal, state and local laws in all locations where Client has employees. PEO Provider agrees that it will ensure the Employee Handbook and all employee-related policies are timely updated and communicated, as necessary, due to changes in the law. If requested, PEO Provider agrees to make any stylistic changes to customize the Employee Handbook and employee-related policies to better reflect Client's culture. |
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2.11 |
Training employees on compliance with workplace policies, including those that may be required by |
law .
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2.12 |
Providing a worksite safety program, including training of WSEs . |
2.13 PEO Provider shall coordinate the on-boarding of new WSEs, including execution of pre-employment screening, back-ground checks, reference checks, drug testing and ensure proper approval and authorization of any and all WSEs changes prior to execution as well as proper completion and filing and maintenance of all relevant WSEs personnel documentation.
2.14 |
PEO Provider shall maintain proper filing and maintenance of all relevant WSEs personnel documentation , employee-related records, as may be require federal and state laws. |
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2.15 |
PEO Provider will ensure benefit vendor invoices at all times properly reflect WSEs benefit selections and related payroll withholdings . Discrepancies will be identified and resolved in a timely manner. |
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2.16 Managing and tracking WSEs paid time-off, observed holidays and employee leaves of absence, ensuring compliance with Client policies.
2.17 PEO Provider and Client are jointly responsible for compliance with all applicable employment laws, including, but not limited to the following federal laws, and their state or local equivalents:
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(a) |
Title VII of the Civil Rights Act of 1964; |
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(b) |
Americans with Disabilities Act, as amended; |
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(c) |
Fair Labor Standards Act; |
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(d) |
Family and Medical Leave Act; |
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(e) |
Section 503 of the Rehabilitation Act; |
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(f) |
Occupational Safety and Health Act of 1970 (OSHA); and |
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(g) |
Immigration laws . |
Exhibit 10.19
2.18 |
PEO Provider shall assume responsibility for recruiting, hiring, and firing workers in addition to Client's responsibility for recruiting, hiring, and firing workers. |
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Exhibit 10.19
\.
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3. |
Rights and Responsibilities of Client. |
3.1 Client agrees, as the Worksite Employer , to be responsible for the following duties described in this Section 3 .
3.2 Client shall have sole responsibility for the day-to-day control and supervision of WSEs, as well as hiring, firing, disciplining or promoting WSEs.
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3.3 |
Properly classify employees as exempt or non-exempt under applicable wage and hour laws . |
3.4 Maintain accurate records regarding time worked by WSEs and timely transmit compensation payment information to PEO Provider for each work pay-cycle on a bi-weekly basis including as applicable:
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(a) |
Wages, including whether salaried or hourly, and regular rate of pay; |
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(b) |
Overtime ; |
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(c) |
Commissions ; |
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(d) |
Bonuses ; |
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(e) |
Vacation pay ; |
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(f) |
Sick pay ; |
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(g) |
Paid time off ; |
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(h) |
Paid leaves of absence; and |
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(i) |
Severance payments. |
3.5 Timely report to PEO Provider any changes in its workforce, such as employees hired or terminated, and any changes in salary, hour wages or other compensation, along with applicable authorizations and approvals .
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3.6 |
Maintain licenses that may be required of any WSEs . |
3 . 8 Provide a safe work environment, in compliance with OSHA , and timely report any work-related injuries to PEO Provider.
4. Term. This Agreement shall commence as of the Effective Date and shall continue thereafter a period of two (2) years with subsequent one (1) year automatic renewal terms, unless sooner terminated pursuant to Section 6 .
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5. |
Fees; Payment Terms. |
5.1 Service Fees . In consideration of the provision of the services by PEO Provider and the rights granted to Client under this Agreement, Client shall pay the fees set forth in Exhibit A
5.2 Payment Terms . PEO Provider shall issue invoices to Client, which shall be due and payable upon receipt after Client receives such invoice, except for any amounts disputed by Client in good faith. All payments hereunder shall be in US dollars and made by check or wire transfer.
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6. |
Termination; Effect of Termination. |
6.1 Either party , in its sole discretion, may terminate this Agreement, in whole or in part, at any time
Exhibit 10.19
without cause, by providing ninety (90) days' prior written notice to the other party. On the termination of this Agreement for any reason, the WSEs will remain employees of the Client as the initial employer.
6.2 Either party may terminate this Agreement , effective upon written notice to the other party (the "Defaulting Party"), if the Defaulting Party:
Exhibit 10.19
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(a) |
(I) materially breaches this Agreement, and such breach is incapable of cure; or (ii) with respect to a material breach capable of cure, the Defaulting Party does not cure such breach within thirty (30) days after receipt of written notice of such breach. |
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(b) (i) becomes insolvent or admits its inability to pay its debts generally as they become due; (ii) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully stayed within seven (7) business days or is not dismissed or vacated within Forty-five (45) days after filing; (iii) is dissolved or liquidated or takes any corporate action for such purpose;
(iv) makes a general assignment for the benefit of creditors; or (v) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
6.3 The rights and obligations of the parties set forth in this Section 6.3 and Section 7, Section 8, Section 9, Section 11, Section 12, Section 13 and Section 14, and any right or obligation of the parties in this Agreement which, by its nature, will survive any such termination or expiration of this Agreement.
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7. |
Intellectual Property Rights; Ownership. |
7.1 Client is, and shall be, the sole and exclusive owner of all right, title and interest in and to the materials provided by PEO Provider pursuant to its obligations under this Agreement (hereafter "Deliverables"), including all intellectual property rights therein. PEO Provider agrees, and will cause its employees (meaning those employees employed by PEO Provider to provide services under this Agreement, who are hereafter referred to as "PEO Provider Personnel") to agree, that with respect to any Deliverables that may qualify as "work made for hire" as defined in 17
U.S.C. § 101, such Deliverables are hereby deemed a "work made for hire" for Client. To the extent that any of the Deliverables do not constitute a "work made for hire", PEO Provider hereby irrevocably assigns, and shall cause PEO Provider Personnel to irrevocably assign to Client, in each case without additional consideration, all right, title and interest throughout all United States territories and to the Deliverables, including all intellectual property rights therein. PEO Provider shall cause PEO Provider Personnel to irrevocably waive, to the extent permitted by applicable law, any and all claims such employees may now or hereafter have in any jurisdiction with respect to the Deliverables.
7.2 Upon the reasonable request of Client, PEO Provider shall, and shall cause PEO Provider Personnel to, promptly take such further actions, including execution and delivery of all appropriate instruments of conveyance, as may be necessary to assist Client to prosecute, register, perfect or record its rights in or to any Deliverables.
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8. |
Confidential Information. |
8.1 Both parties may be given access to or acquire information which is proprietary or confidential to the other party and its affiliated companies, clients and customers. Any and all such information obtained by either party or the WSEs shall be deemed to be confidential and proprietary information. Both parties agree to hold such information in strict confidence and not to disclose such information to third parties or to use such information for any purposes whatsoever other than the providing of Services under this Agreement. Either party may request WSEs or employees of the PEO Provider responsible for providing Services to the Client to enter into confidentiality agreements.
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9. |
Representations and Warranties. |
Exhibit 10.19
9.1 Each party represents and warrants to the other party that:
(a) it is duly organized, validly existing and in good standing as a corporation or other entity as represented herein under the laws and regulations of its jurisdiction of incorporation, organization or chartering;
Exhibit 10.19
(b) it has the full right, power and authority to enter into this Agreement, to grant any rights and licenses granted hereunder and to perform its obligations hereunder;
(c) the execution of this Agreement by its representative whose signature is set forth at the end hereof has been duly authorized by all necessary corporate action of the party; and
(d) when executed and delivered by such party, this Agreement will constitute the legal, valid and binding obligation of such party, enforceable against such party in accordance with its terms.
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9.2 |
PEO Provider represents and warrants to Client that : |
(a) it shall perform the Services using personnel of required skill, experience and qualifications and in a professional and workmanlike manner in accordance with generally recognized and commercially reasonable industry standards for similar services and shall devote adequate resources to meet its obligations under this Agreement;
(b) it is a Licensed Professional Employer Organization by the Texas Department of Licensing and Regulation and will maintain in good standing at all times such license;
(c) it is in compliance with, and shall perform the Services in compliance with, all applicable laws, including PEG-specific laws in states where WSEs are located;
9.3 EXCEPT FOR THE EXPRESS WARRANTIES IN THIS AGREEMENT, (A) EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES, EITHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE UNDER THIS AGREEMENT, AND (B) PEO PROVIDER SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANT ABILITY, AND FITNESS FOR AP ARTICULAR PURPOSE.
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10. |
Indemnification. |
10.1 PEO Provider shall defend, indemnify and hold harmless Client and its officers, directors, employees, agents, successors and permitted assigns (each, a "Client Indemnitee") from and against any and all claims, demands, damages (including liquidated, punitive and compensatory), actions in state or federal courts or before administrative agencies, losses and liabilities, costs and expenses (including attorneys' fees) and monetary fines or penalties assessed by any administrative agency (hereafter "Actions") arising out of or resulting from:
(a) bodily injury, death of any person or damage to real or tangible, personal property resulting from the willful, fraudulent or negligent acts or omissions of PEO Provider or PEO Provider Personnel; and
(b) PEO Provider's breach of any representation, warranty or obligation of PEO Provider set forth in this Agreement, including PEO Provider's failure to comply with all employment laws in connection with the Services provided by PEO Provider under this Agreement.
10.2 Client shall defend, indemnify and hold harmless PEO Provider and its officers, directors, employees, agents, successors and permitted assigns from and against any and all Actions arising out of or resulting from:
(a) bodily injury, death of any person or damage to real or tangible, personal property resulting from the [grossly] negligent or willful acts or omissions of Client; and
Exhibit 10.19
10.3 The party seeking indemnification hereunder shall promptly notify the indemnifying party in writing of any Action and cooperate with the indemnifying party at the indemnifying party's sole cost and expense. The indemnifying party shall immediately take control of the defense and investigation of such Action and shall employ
Exhibit 10.19
counsel of its choice to handle and defend the same, at the indemnifying party's sole cost and expense . The indemnifying party shall not settle any Action in a manner that adversely affects the rights of the indemnified party without the indemnified party's prior written consent , which shall not be unreasonably withheld or delayed . The indemnified party's failure to perform any obligations under this Section 10.3 shall not relieve the indemnifying party of its obligations under this Section 10.3 except to the extent that the indemnifying party can demonstrate that it has been materially prejudiced as a result of such failure . The indemnified party may participate in and observe the proceedings at its own cost and expense .
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11. |
Limitation of Liability. |
11.1 EXCEPT AS OTHERWISE PROVIDED IN Section 11 . 3, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER OR TO ANY THIRD PARTY FOR ANY LOSS OF USE, REVENUE OR PROFIT OR LOSS OF DATA OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL OR PUNITIVE DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES .
11.2 EXCEPT AS OTHERWISE PROVIDED IN Section 11.3, IN NO EVENT WILL EITHER PARTY'S LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EXCEED TWO (2) TIMES THE AGGREGATE AMOUNTS PAID OR PAYABLE TO PEO PROVIDER PURSUANT TO THIS AGREEMENT.
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11.3 |
The exclusions and limitations in Section 11.1 and Section 11.2 shall not apply to : |
(a) damages or other liabilities arising out of or relating to a party's failure to comply with its obligations under Section 7 (Intellectual Property Rights ; Ownership) ;
(b) damages or other liabilities arising out of or relating to a party's failure to comply with its obligations under Section 8 (Confidential Information) ;
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(c) |
a party's indemnification obligations under Section 10 (Indemnification); |
(d) damages or other liabilities arising out of or relating to a party's gross negligence, willful misconduct or intentional acts ;
(e) death or bodily injury or damage to real or tangible personal property resulting from a party's negligent acts or omissions;
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(f) |
damages or liabilities to the extent covered by a party's insurance; and |
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(g) |
a party's obligation to pay attorneys' fees and court costs in accordance with Section 14 . 2 . ]] |
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12. |
Insurance. |
12.1 At all times during the Term of this Agreement and for a period of three years thereafter, PEO Provider shall procure and maintain, at its sole cost and expense, at least the following types and amounts of insurance coverage :
Exhibit 10.19
(a) Commercial General Liability with limits no less than $ 1 , 000,000 . 00 per occurrence and
$2,000,000.00 in the aggregate, including bodily injury and property damage and products and completed operations, which policy will include contractual liability coverage insuring the activities of PEO Provider under this Agreement;
Exhibit 10.19
(b) Worker's Compensation with limits no less than the greater of (i) $1 , 000,000 . 00 or (ii) the minimum amount required by applicable law;
(c) If and when applicable, ERISA fidelity bond covering the qualified retirement plan or any other employee benefit plan as required by Section 412 of the Employee Retirement Income Security Action of 1974 (ERISA) in an amount determined under DOL Reg . § 2580.412-11. The ERISA fidelity bond shall satisfy the requirements of ERISA Section 412 and the regulations ;
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Commercial Automobile Liability with limits no less than $1,000,000 . 00, combined single limit; |
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(e) |
Errors and Omissions/Professional Liability with limits no less than $1,000,000 . 00 per occurrence |
and $2,000,000.00 in the aggregate.
12.2 Except for the ERISA fidelity bond required in Section 12. l(c), all insurance policies required pursuant to this Section 12 shall:
(a) be issued by insurance companies reasonably acceptable to Client ;
(b) provide that such insurance carriers give Client at least 30 days' prior written notice of cancellation or non-renewal of policy coverage; provided that , prior to such cancellation, the PEO Provider shall have new insurance policies in place that meet the requirements of this Section 12;
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(c) |
waive any right of subrogation of the insurers against the Client . |
(d) provide that such insurance be primary insurance and any similar insurance in the name of and / or for the benefit of Client shall be excess and non-contributo ry ; and
(e) name Client and Client's Affiliates , including, in each case, all successors and permitted assigns , as additional insureds .
12.3 Upon the written request of Client, PEO Provider shall provide Client with copies of the certificates of insurance and policy endorsements for all insurance coverage required by this Section 12, and shall not do anything to invalidate such insurance . This Section 12 shall not be construed in any manner as waiving, restricting or limiting the liability of either party for any obligations imposed under this Agreement (including but not limited to, any provisions requiring a party hereto to indemnify , defend and hold the other harmless under this Agreement) .
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13. |
Non-Solicitation. |
13.1 During the Term of this Agreement and for a period of twenty-four (24) months thereafter, neither party shall , directly or indirectly, in any manner solicit or induce for employment any person who performed any work under this Agreement who is then in the employment of the other party . A general advertisement or notice of a job listing or opening or other similar general publication of a job search or availability to fill employment positions, including on the internet , shall not be construed as a solicitation or inducement for the purposes of this Section 13.1, and the hiring of any such employees or independent contractor who freely responds thereto shall not be a breach of this Section 13 . 1.
Exhibit 10.19
13.2 If either PEO Provider or Client Breaches Section 13.1, the breaching party shall, on demand , pay to the non-breaching party a sum equal to two (2) year's basic salary and the annual fee that was payable by the claiming party to that employee, worker or independent contractor plus the recruitment costs incurred by the non-breaching party in replacing such person .
Exhibit 10.19
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14. |
Notices. |
14.1 All notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been given (a) when delivered by hand (with written confirmation of receipt);
(b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next business day if sent after normal business hours of the recipient or (d) on the third (3rd) day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. Such communications must be sent to the respective parties at the addresses indicated below (or at such other address for a party as shall be specified in a notice given in accordance with this Section 14 .1.
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If to PEO Provider: |
1565 North Central Expressway Suite 300 |
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Richardson, TX 75080
Facsimile: 972.354,5568
Attention: Chief Financial Officer
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If to Client: |
1565 North Central Expressway Suite 200 |
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Richardson, TX 75080
Facsimile: 972.354,5568
Attention: Chief Executive Officer
14.2 For purposes of this Agreement, (a) the words "include," "includes" and "including" shall be deemed to be followed by the words "without limitation"; (b) the word "or" is not exclusive; and (c) the words "herein," "hereof," "hereby," "hereto" and "hereunder" refer to this Agreement. Unless the context otherwise requires, references herein: (x) to Sections, Schedules, Exhibits and Statements of Work refer to the Sections of, and Schedules and Exhibits attached to this Agreement; (y) to an agreement, instrument or other document means such agreement, instrument or other document as amended, supplemented and modified from time to time to the extent permitted by the provisions thereof and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting an instrument or causing any instrument to be drafted. The Schedules and Exhibits referred to herein shall be construed with, and as an integral part of, this Agreement to the same extent as if they were set forth verbatim herein.
14.3 This Agreement, together with all Schedules, Exhibits and any other documents incorporated herein by reference, constitutes the sole and entire agreement of the parties to this Agreement with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings and agreements, both written and oral, with respect to such subject matter . In the event of any conflict between the terms and provisions of this Agreement and those of any Schedule or Exhibit, the following order of precedence shall govern: (a) first, this Agreement,
Exhibit 10.19
exclusive of its Exhibits and Schedules; and (b) second, any Exhibits and Schedules to this Agreement.
14.4 Neither party may assign, transfer or delegate any or all of its rights or obligations under this Agreement, without the prior written consent of the other party, which consent shall not be unreasonably withheld or delayed. No assignment shall relieve the assigning party of any of its obligations hereunder. Any attempted assignment, transfer or other conveyance in violation of the foregoing shall be null and void. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns.
Exhibit 10.19
14.5 This Agreement is for the sole benefit of the parties hereto and their respective successors and permitted assigns and nothing herein, express or implied, is intended to or shall confer upon any other Person any legal or equitable right, benefit or remedy of any nature whatsoever, under or by reason of this Agreement.
14.6 The headings in this Agreement are for reference only and shall not affect the interpretation of this Agreement.
14.7 This Agreement may only be amended, modified or supplemented by an agreement in writing signed by each party hereto . No waiver by any party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any rights, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.
14.8 If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction . Upon such determination that any term or other provision is invalid, illegal or unenforceable , the parties hereto shall negotiate in good faith to modify this Agreement to affect the original intent of the parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible .
14.9 This Agreement shall be governed by and construed in accordance with the internal laws of the State of Texas without giving effect to any choice or conflict of law provision or rule or any other jurisdiction that would cause the application of Laws of any jurisdiction other than those of the State of Texas. Any legal suit , action or proceeding arising out of this Agreement or the Services provided hereunder be instituted in the federal courts of the United States or the courts of the State of Texas in each case located in the city of Richardson and County of Dallas , and each party irrevocably submits to the exclusive jurisdiction of such courts in any such suit , action or proceeding . Service of process , summons, notice or other document by mail to such party's address set forth herein shall be effective service of process for any suit, action or other proceeding brought in any such court .
14.10 Each party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement or the transactions contemplated hereby.
14.11 Each party acknowledges that a breach by a party of Section 7 (Intellectual Property Rights; Ownership) or Section 8 (Confidential Information) may cause the non-breaching party irreparable damages, for which an award of damages would not be adequate compensation and agrees that, in the event of such breach or threatened breach , the non-breaching party will be entitled to seek equitable relief, including a restraining order, injunctive relief, specific performance and any other relief that may be available from any court, in addition to any other remedy to which the non-breaching party may be entitled at law or in equity . Such remedies shall not be deemed to be exclusive but shall be in addition to all other remedies available at law or in equity, subject to any express exclusions or limitations in this Agreement to the contrary.
14.12 In the event that any action , suit, or other legal or administrative proceeding is instituted or commenced by either party hereto against the other party arising out of or related to this Agreement, the prevailing party shall be entitled to recover its attorneys' fees and court costs from the non-prevailing party .
14.13 This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of
Exhibit 10.19
which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile , e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
Exhibit 10.19
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written .
AmBio Staffing, LLC
Name: Mark W. Brooks Title: Managing Member
Title: Chief Financial Officer
EXHIBIT A
FEE SCHEDULE
EXHIBIT B
EMPLOYEE BENEFITS ADDENDUM
Exhibit 21.1
Fuse Medical, Inc.
(A Delaware Corporation)
List of Significant Subsidiaries
(As of December 31, 2017)
CPM Medical Consultants, LLC
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
I, Christopher C. Reeg, certify that:
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1. |
I have reviewed this annual report on Form 10-K of Fuse Medical, Inc.; |
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2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
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3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
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a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: April 5, 2018
/s/ Christopher C. Reeg |
Christopher C. Reeg Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I, William E. McLaughlin, III, certify that:
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1. |
I have reviewed this annual report on Form 10-K of Fuse Medical, Inc.; |
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
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5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
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b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: April 5, 2018
/s/ William E. McLaughlin, III |
William E. McLaughlin, III Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of Fuse Medical, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission on the date hereof, I, Christopher Reeg, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
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1. |
The annual report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and |
|
2. |
The information contained in the annual report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Christopher C. Reeg |
Christopher C. Reeg Chief Executive Officer (Principal Executive Officer) |
Dated: April 5, 2018
In connection with the annual report of Fuse Medical, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission on the date hereof, I, William McLaughlin, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
|
1. |
The annual report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and |
|
2. |
The information contained in the annual report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ William E. McLaughlin, III |
William E. McLaughlin, III Chief Financial Officer (Principal Financial Officer) |
Dated: April 5, 2018