IN WITNESS WHEREOF, the Recipient Party has truthfully completed the form below and executed this Confidentiality and Non-Disclosure Agreement as of the date that appears below.
IN WITNESS WHEREOF, the Recipient Party has truthfully completed the form below and executed this Confidentiality and Non-Disclosure Agreement as of the date that appears below.
THIS CONFIDENTIALITY AND NON-DISCLOSURE AGREEMENT (this “Agreement”) is entered into and is effective as of the date specified at the end of the Agreement, by and between AngioCure, Inc. and all its subsidiaries (the “Disclosing Party”) and the “Recipient Party” as specified at the end of the Agreement).
In consideration of the mutual promises contained herein, and for other good and valuable consideration, the receipt, sufficiency and adequacy of which are hereby acknowledged, the parties agree as follows:
Section 1.Purpose. The Recipient Party has requested that the Disclosing Party divulge certain Confidential Information (as defined below) to the Recipient Party in connection with a possible investment by the Recipient Party in securities of the Disclosing Party (the “Potential Investment”).
Section 2.Restrictions on Use and Disclosure; Property Rights.
(a) The Recipient Party shall use the Confidential Information for the sole purpose ofevaluating a possible or actual investment in the Disclosing Party. The Confidential Information shall be shared with and used only by the Recipient Party and its financial and legal advisors engaged with respect to the Potential Investment. The Recipient Party (and its advisors) shallnot disclose any of the Confidential Information to any third party whatsoever except as provided herein without prior written consent of the Disclosing Party.
(b) As used herein, term “Confidential Information” means:
(i) any information, data, or know-how that is competitively sensitive, including without limitation information that relates to research and development, the business plan, offering documents, planning information, products, services, customers, partners (including AngioCure LLC, Halo Management Group LLC and ES Medical LLC), strategic alliances, marketing strategies, technical plans, operations, prices, customer lists and relationships, business plans, developments, inventions, processes, designs, drawings, engineering, hardware configuration information, technology, coding marketing or finances of the Disclosing Party and the names of its personnel;
(ii) any scientific or technical information, design, process, procedure, formula or improvement;
(iii) all confidential or proprietary concepts, documentation, reports, data, specifications, flow charts, diagrams, databases, inventions, software (source or object code), information and trade secrets, whether or not patentable or copyrightable;
(iv) various non-public descriptions of surgical devices, implants, products and designs, concepts, ideas and strategies technical drawings and animations; and
(v) any documents or information designated in writing to be confidential or proprietary, or if given orally is identified as confidential or proprietary at the time of disclosure, or, in each case, which would reasonably be considered to be confidential.
Section 3.Rights. The Disclosing Party shall retain all right, title and interest in and to its Confidential Information and any and all derivatives thereof. Nothing in this Agreement is intended to grant any rights in or to the Disclosing Party’s Confidential Information other than the limited right to review such Confidential Information in connection with the Potential Investment.
Section 4.Care of Confidential Information. The Recipient Party shall not duplicate any Confidential Information and shall treat all Confidential Information with the same degree of care with respect to preserving its confidentiality as the Recipient Party accords to information of a similar nature regarding the Recipient Party or its business, but in no event less than reasonable care.
Section 5.Indemnity. The Recipient Party shall indemnify, defend and hold harmless the Disclosing Party from and against any claim, demand, cause of action, loss or liability (including attorneys fees and expenses of litigation) arising out of or in connection with any violation by the Recipient Party, or any of its officers, directors, employees, consultants or advisors, of any of the provisions of this Agreement.
Section 6.Exceptions to Restrictions. The obligations not to use or disclose Confidential Information set forth in Section 2 hereof shall not apply to any portion of such Confidential Information that, at the time of such use or disclosure: (a) is generally known by the public through no fault or participation by the Recipient Party; (b) was rightfully in the Recipient Party’s possession free of any obligation not to use or disclose such Confidential Information and, if such Confidential Information was disclosed to the Recipient Party by a third party, such third party was not, by disclosing such Confidential Information to the Recipient Party, in breach of any obligation of confidentiality to anyone; (c) has been independently developed by the Recipient Party without the use of Confidential Information; or (d) subject to compliance with Section 7 hereof, is disclosed in response to a valid order issued by a court or other governmental authority or otherwise as required by law.
Section 7.Notice of Required Disclosure. If the Recipient Party is required to disclose any Confidential Information pursuant to a valid order issued by a court or other governmental authority or otherwise pursuant to law, including, but not limited to by oral inquiry, notice of deposition, interrogatory, request for information or documents, subpoena, demand or similar process the Recipient Party shall provide the Disclosing Party with prompt notice of such inquiry, notice, interrogatory, request, subpoena, demand or similar process so that the Disclosing Party may seek an appropriate protective order or other relief or otherwise seek to prevent disclosure of such Confidential Information. In the event that no such protective order or other remedy is obtained or that the Disclosing Party waives compliance with the terms of this Agreement and that the Disclosing Party are nonetheless legally compelled to disclose such Confidential Information, the Disclosing Party shall furnish only that portion of the Confidential Information which it is advised by counsel is legally required and will give the Disclosing Party written notice (unless prohibited by law) of the Confidential Information to be disclosed as far in advance as practicable and exercise all reasonable efforts to obtain reliable assurance that confidential treatment will be accorded the Information.
Section 8.Injunctive Relief; Recovery of Costs of Enforcement. The parties hereto acknowledge that the Confidential Information is of a special, unique and extraordinary character, that the Disclosing Party would be immediately and irreparably harmed by any disclosure thereof in violation of this Agreement, and that the Disclosing Party will not have an adequate remedy at law or be compensable by damages alone in the event the Recipient Party, or anyone to whom the Recipient Party discloses Confidential Information, repudiates or breaches the provisions hereof, or threatens or attempts to do so. For these reasons, the Disclosing Party, in addition and not in limitation of any other rights, remedies or damages, at law or in equity, shall be entitled to seek temporary, preliminary or permanent injunctive relief without the posting of any bond or other security to prevent the use and/or disclosure of Confidential Information not authorized by this Agreement or by the Disclosing Party in writing. The prevailing party in any litigation to enforce the provisions of this Agreement shall be entitled to recover its reasonable attorney’s fees and costs. Each party agrees that its obligations provided in this Agreement are necessary and reasonable in order to protect the Disclosing Party and its business, and each party expressly agrees that monetary damages would be inadequate to compensate the Disclosing Party for any breach by the Recipient Party of its covenants and agreements set forth in this Agreement. Accordingly, each party agrees and acknowledges that any such violation or threatened violation will cause irreparable injury to the Disclosing Party and that, in addition to any other remedies that may be available, in law, in equity or otherwise, the Disclosing Party shall be entitled to obtain injunctive relief against the threatened breach of this Agreement or the continuation of any such breach by the Recipient Party, without the necessity of proving actual damages.
Section 9.Return and/or Destruction of Confidential Information. Upon request of the Disclosing Party, the Recipient Party shall promptly return to the Disclosing Party or, at the option of the Disclosing Party destroy, all Confidential Information and all databases, documents and other materials in whatever form that contain any Confidential Information or any conclusions, statements or other information made or derived in whole or in part on the basis of or from any Confidential Information, irrespective of by whom such databases, documents and other materials were prepared. Such materials shall also be returned or destroyed by the Recipient Party promptly upon (the Recipient Party declining to make an investment in the Disclosing Party. The Recipient Party shall promptly furnish to the Disclosing Party written certification of the Recipient Party’s compliance with this Section.
Section 10.Entire Agreement. This Agreement constitutes the entire understanding and agreement between the parties, merges and supersedes all previous communications, representations and agreements, whether oral or written, with respect to the subject matter hereof, and may not be changed, modified or terminated in whole or in part, except by an instrument in writing executed by all the parties hereto. No failure or delay by a party in exercising any right, power or privilege hereunder shall operate as a waiver thereof or preclude the exercise of any other or further right, power or privilege hereunder.
Section 11.Assignment; Binding Effect. Recipient Party may not assign this Agreement or any rights or obligations hereunder, nor may a Recipient Party delegate any of its obligations or duties hereunder, to anyone without the prior written consent of the Disclosing Party and any assignment or delegation without such consent shall be null and void. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, successors, personal representatives and permitted assigns. The Disclosing Party may assign this Agreement, its rights and or obligations hereunder to a parent company, a subsidiary or any current or future affiliate.
Section 12.Notices. All notices required or permitted to be given hereunder shall be in writing and may be given only in person or by posting the same certified or registered mail, postage prepaid, or by private courier (provided the courier shall verify time and place of delivery), or by facsimile transmission (confirmed by mailing by certified or registered mail of paper copy within 48 hours), to the affected party at the address stated on the signature page to this Agreement.
Section 13.No Representations or Warranties. By executing this Agreement, the Disclosing Party makes no representations or warranties, express or implied, as to the accuracy, completeness or efficacy of its Confidential Information, and to the extent any such Confidential Information is provided to the Recipient Party such Confidential Information is provided “as is.”
Section 14.Governing Law. This Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of California, and the parties consent to and hereby submit to the jurisdiction of the state and federal courts in California for the purpose of adjudicating any dispute between the parties arising hereunder.
Section 15.No Commitments. Nothing in this Agreement requires the Recipient Party to make an investment in the Disclosing Party and nothing in this Agreement requires the Disclosing Party to accept an investment offer from the Recipient Party.
Section 16.Severability. If any provision of this Agreement is held by a court to be illegal, invalid or unenforceable, the remaining provisions of this Agreement shall not be affected or impaired thereby, and this Agreement shall be construed so as to achieve as nearly as possible the same intended economic effect as the Agreement in its original form, as amended.
Section 17.Authority to Bind, Binding Effect; No Waiver. Each of the undersigned represents and warrants that it has the full power and authority to bind the named parties to the provisions hereof. Failure to enforce any provision of this Agreement by a party shall not constitute a waiver of any term hereof by such party.
Section 18. Term. This Agreement shall govern all communications from the Disclosing Party to the Recipient Party until such time as either party receives from the other written notice that subsequent communications between them shall not be so governed. Such notice shall not affect, however, the Recipient Party’s obligations hereunder with respect to Confidential Information disclosed to the Recipient Party or its officers, directors, employees and professional advisors prior to the Disclosing Party’s giving or receipt of such notice, which obligations shall survive.
Section 19.Headings. The headings of the Sections of this Agreement are for convenience only and shall not affect the interpretation of this Agreement.
Section 20. Counterparts.This Agreement, and any amendment thereof, may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same document.
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AngioCure is currently seeking investment to take its revolutionary Clear Vessel technology to market. Investors who would like to gain access to our investor portal and review the AngioCure investor documents and due dillegence materials will first need to register with AngioCure and request access to the Investor Portal.
In an effort to protect AngioCure's Intellectual Property and to further adhere to the Securities and Exchange Commission's (SEC) Compliance Regulations under Rule 506(d) we would like to request that you complete the following steps prior to your access being granted.
Furthermore, all registrants need to be manually approved by the AngioCure team. Registration is not automated and will not provide you with instant access. The link to register is below the NDA. Thank you for your interest in AngioCure! We look forward to providing you with the information you require to make an informed investment decision.
Step 1: Read & Sign the Non-Disclosure Agreement (NDA)
Below is a link to the NDA for Investors which must be filled out and digitally authenticated/signed in order to finalize your registration. After you have completed and authenticated the NDA, you will go to the next step to request access to the AngioCure Investor Portal.
Step 2: Request Investor Access
After reading and submitting your digital authentication/signature for the NDA, you also need to register on the website for access to the investor portal. You will be presented with the page to request access after you complete the NDA.
It may take a short period of time for us to review your request before your access is granted. You will be notified by email when it has been approved.
PLEASE NOTE: The approval email will come from OneHub, not AngioCure. The email from OneHub links to the AngioCure Investor Portal data room. You will need to create a username and password on OneHub in order to gain access.
Thank you for your interest in AngioCure!
If you already have registered for a OneHub account to access the Sanovas Investor Portal you can use this form to log in.
Significant Unmet Clinical Need:
Vascular disease is often treated via the implantation of stents that are designed to expand the vessels and remain in place. Many stents are combined with drugs (Drug-Eluting Stents, or DES) to prevent endothelialization and vessel restenosis. The scientific literature, however, has been reporting high incidence of restenosis with both stents and DES within 10 years of implantation. Thus, for many patients, it is not feasible to implant stents. Other complications can include thrombosis (clot formation).
To address the complications and short lifespan of stents and DES, interventional science has experienced a trend toward ‘Directional’ atherectomy technologies that scrape or drill the plaque out of the vessels, in the effort to restore vessel integrity organically. Regrettably, these new Directional methods lack any kind of intuitive architecture that afford physicians the physiologic intelligence and intuitive command of vessel integrity to mitigate adverse events. Effectively, they exert too much concentric force and/or linear translation upon the vessel. These mechanical side effects compromise the structural integrity of the vessel, resulting in vessel perforation, pseudo-aneurysm, stroke and even death.
AngioCure was founded to deliver an entirely new class of interventional tools called ‘Smart Balloon Catheters’, such as TOP-C, which possess the physiologic intelligence and device characteristics that not only advance physicians’ intra-operative skills but also their intuitive command of vessel integrity to deliver safe, reproducible results across the broad spectrum of diverse and challenging patient populations.
No Regulatory Hurdles:
The AngioCure TOP-C ‘Smart Balloon Catheter’ will follow the 510(k) regulatory path. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is “equivalent” to a device already placed into one of the three classification categories. “Class 1” predicate devices are already in the U.S. market. This means that AngioCure expects to be able to quickly gain clearance to market TOP-C in the United States.
Favorable Medical Economics:
Cardiovascular intervention procedures are shifting away from Drug Eluting Stents (DES) toward Drug Eluting Balloons (DEB). While effective, DEB performance includes the following: 10% of the drug may be lost during catheter placement; 80% of the drug is transferred off the balloon during inflation, but most is lost downstream. Consequently, only about 20% of the drug is transferred to vessel wall membranes.
Drug Eluting Balloons are desirable because they are easy to use and leave nothing implanted in the patient at the end of a procedure. The market for Drug Eluting Balloons is expected to be $127M USD by 2017, at an annual growth rate of 8.1%. Drug Eluting Balloons are expected to be used in 90%+ of all peripheral percutaneous vascular procedures. A growing need for peripheral intervention procedures, significant incidence of restenosis after stenting, and bifurcated lesions point to a market of nearly $8 billion for the AngioCure’s TOP-C Smart balloon Catheter.
Validated Product Concept:
(How can we communicate that TOP-C “works?”)
Extensive IP Protection:
AngioCure has numerous patents and patents pending for its Smart Balloon Catheters. Specific details are subject to restricted access.
Significant Competitive Advantages:
AngioCure’s intellectual properties safeguard its development of an all-new class of semi-compliant Smart Balloon Catheters, comprised of: (1) A proprietary physiologic metric and biofeedback technology system, PhysioSense™; (2) its new class of Plug-N-Play Surgical Camera, AngioCam™; and (3) its proprietary extravasated drug delivery platform, NanoVas™. These patent-protected assets afford AngioCure a dramatic, next-generation advantage in the commercialization of sophisticated, physiologically intelligent devices. Like nothing else available in the market, AngioCure’s technologies are designed to empower surgeons with an entirely new armamentarium of medical devices that advance physicians’ intra-operative skills along with their intuitive command of vessel integrity to help them deliver safe, reproducible results across the broad spectrum of diverse and challenging patient populations.
Experienced, Successful Leadership:
Stephen C. Schimpff, M.D., is Chairman of the AngioCure Scientific Advisory Board. Dr. Schimpff is the retired CEO of the University of Maryland Medical Center. Dr. Schimpff is a consultant to the United States Army on mechanisms to interdigitate high technology into improved patient safety in the “operating room of the future.” He has been consultant to the Battelle Memorial Institute in techniques to assist states or institutions to increase translational research. He continues as a voluntary Professor of Medicine at the University of Maryland.
Attractive Exit Validation:
C. R. Bard’s Peripheral Vascular Division acquired Lutonix for $325 million. Maquet Vascular acquired Atrium Medical for $680 million. Medrad Interventional, a unit of Bayer AG, acquired Pathway Medical for $125 million. Medtronic acquired Invatec for $350 million. Terumo acquired Arterial Remodeling Technologies for $144 million.