Document:

Exhibit

Exhibit 10.6

Supply Agreement
This Supply Agreement (“Agreement”) is entered into as of the Effective Date by and between Cordis Corporation, a corporation duly organized and existing under the laws of the state of Florida and having its principal office at 430 Route 22 East, Bridgewater, NJ 08807-0908 (“Cordis” and a “Party”), and Silk Road Medical, Inc., a corporation duly organized and existing under the laws of the state of Delaware and having its principal office at 735 North Pastoria Avenue, Sunnyvale, California 94085 (“SRM”, a “Party”, and collectively with Cordis, the “Parties”).
WHEREAS, Cordis and SRM entered into a License Agreement on December 17, 2010 (“License Agreement”) whereby Cordis licensed to SRM certain intellectual property related to the PRECISE® Carotid Stent System, including the right to reference clinical data and other information contained in the Cordis Premarket Approval Application P030047, and all supplements thereto, for SRM to develop a modified stent delivery system optimized for transcervical.implantation of the PRECISE® carotid stent;
WHEREAS, the License Agreement contemplates, among other things, Cordis and SRM working together for the development, manufacture and supply of Product (defined below);
WHEREAS, SRM wishes to obtain supply of Product from Cordis for conducting preclinical and clinical trials with the Product and for commercializing Product upon SRM’s receipt of necessary regulatory approvals and/or clearances; and
WHEREAS, the Parties wish to work together pursuant to the terms of this Agreement.
NOW THEREFORE, in consideration of the premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1.DEFINITIONS
All capitalized terms shall have the same meaning as in the License Agreement, unless otherwise defined herein this Article 1 or elsewhere in this Agreement.
1.1.    “Applicable Laws” means all laws, statutes, ordinances, codes, rules, regulations, guidelines and procedures enacted or made by any government, division or agency thereof with applicable jurisdiction, including a Regulatory Authority, that are in force during the Term.
1.2.    “Clinical Study” means a clinical study conducted by SRM to test the safety and/or efficacy and/or functional performance of the Product.
1.3.    “Development Services” shall have the meaning set forth in Section 2.2 of this Agreement.
1.4.    “Effective Date” of this Agreement shall mean the last date of signature below.

[***]     Information has been omitted and submitted separately to the Securities and Exchange Commission. Confidential 
treatment has been requested with respect to the omitted portions.

1.5.    “Facility” means the manufacturing facility owned by Cordis de Mexico, S.A. de C.V. located in Juarez, Mexico (“Cordis Mexico”), where the Development Services and the Product will be manufactured, and for which Cordis has a service agreement with Cordis de Mexico, S.A. de C.V. to perform services for Cordis as set forth in Section 2.5.
1.6.    “Product” shall mean a stent delivery system with a PRECISE® carotid stent, for use only for transcervical implantation, manufactured and packaged, sterilized, and supplied by Cordis or its affiliates or subcontractors, in accordance with the Specifications.  Until such time as the Specification is agreed to by the Parties in writing signed by an authorized representative of each Party, the Product shall mean a stent delivery system with a PRECISE® carotid stent for use only for transcervical implantation as described in the Product Description.
1.7.    “Product Description” shall mean the design inputs, as set forth in Exhibit 1, as may be amended by the Parties in writing signed by an authorized representative of each Party.
1.8.    “QS” shall mean (a) current Quality System Regulations (QSR), as defined by the FDA and International Conference on Harmonization (ICH) guidelines, including 21 C.F.R, § 820 et seq.; and (b) all laws, rules, guidelines, regulations and standards of governmental authorities (including without limitation ISO 9001/ISO13485) in the United States, Europe and/or at the location of the Facility, that apply to the Product, the manufacturing process, the documentation or the Facility, or any other facilities in which the manufacturing process is performed.
1.9.    “Specification” shall mean the device master record, including, but not limited to the guidelines and requirements for the design, composition, product safety assurance, manufacture, packaging, sterilization, and/or quality control for the Product, and the specification itself, which are agreed to in a writing signed by an authorized representative of each Party, and which following such written agreement, shall be incorporated by reference in this Agreement as if attached hereto.  Any amendment to the Specification may be made only according to the terms and conditions of Section 2.3 of this Agreement.
1.10.    “SRM Neuroprotection System” means MICHITM Neuroprotection System, an access and embolic protection system for transcervical carotid artery stenting procedures which is owned and/or controlled by SRM.
1.11.    “Term” shall have the meaning set forth in Section 11.1 of this Agreement.
2.    PRODUCT DEVELOPMENT AND MANUFACTURE
2.1.    Development and Manufacture.  Cordis will perform Development Services, manufacture, and sell the Product to SRM in conformance with the Specifications, QS, Applicable Laws and otherwise in accordance with the terms and conditions of this Agreement and the License Agreement,
2.2.    Design Development.  Cordis will perform the development services in accordance with Cordis’ standard design control procedures and as set forth in Exhibits 1-4 and the time periods set forth in Exhibit 4 (the “Development Services”), Cordis shall provide SRM the 

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design review deliverables and applicable documentation as set forth in Exhibit 2 (the “Design and Development Plan”).  As part of the Development Services, Cordis will supply Product to SRM according to the volume and schedule in Exhibit 3 for SRM’s internal testing purposes.
2.2.1.    Quality System.  Cordis will use its QS procedures, including, but not limited to its standard design control procedures for all Development Services and procedures for manufacturing, documentation control, purchasing control, material identification, production and process controls, inspection and measurement controls, product acceptance activities, and change control, as it pertains to the development and manufacture of the Product.
2.2.2.    Design and Development Planning.  Cordis will conduct design reviews and generate documents in accordance with Cordis’ standard design control procedures. Cordis will provide reasonable notice of all scheduled design reviews with respect to the Product and SRM will have the right to attend and contribute to the design reviews. If there are any delays by Cordis in the implementation of the Design and Development Plan, and meeting the timelines set forth therein, Cordis shall provide notice in writing of any such delays to SRM. In the event Cordis is unable to complete any of the Milestones (as defined in Section 2.4.1) upon the timelines set forth in Exhibit 4, Cordis shall provide notice in writing to SRM explaining any such delays, and the Parties shall meet and confer as to amendments to the timeline and how to expedite the completion of the Milestones within a reasonable timeframe.
2.3.    Changes to Manufacturing of Product.
2.3.1.    Cordis Changes. Notwithstanding Section 6.2(c) of the License
Agreement,
(i)    Cordis may make changes to the Specification and/or manufacture of the Product, without SRM’s approval (including without limitation the manufacturing processes and raw materials contained therein or otherwise used to manufacture the Product), provided that such changes are within the ranges set forth in the Specification and Cordis (a) provides advance written notice to SRM of such changes, and (b) provides to SRM, pursuant to the criteria set forth in Form 12364266 (attached as Exhibit 7 to this Agreement), as may be amended by Cordis, and Form 12553603, (attached as Exhibit 8 to this Agreement), as may be amended by Cordis, a regulatory assessment of the changes to the specification and/or manufacture of the PRECISE® Carotid Stent System, such assessment is provided “as is,” without any representations or warranties, and shall be treated as Cordis Confidential Information, and (c) provides timely confirmation to SRM that the regulatory assessment in 233 (i)(b) did not require approval of a Regulatory Authority for the changes to the specification and/or manufacture of the PRECISE® Carotid Stent System, 

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such confirmation is provided “as is,” without representations or warranties, and shall be treated as Cordis Confidential Information. hi the event that any change by Cordis within the ranges set forth in the Specification requires Cordis receive approval of a Regulatory Authority for the PRECISE® Carotid Stent System, and therefore SRM receive approval of a Regulatory Authority for the Product, SRM may within fifteen (15) days of the date of delivery of the regulatory assessment, submit to Cordis one (1) purchase order for up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, manufactured according to the pre-change Specification and manufacturing process, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates in writing; except that if after using commercially reasonable efforts to obtain raw materials, such materials are not available, Cordis shall have no obligation to supply Product pursuant to this sentence. In the case of a change pursuant to Section 2.3.1(1), except as set forth in this Section 2.3.1(i), Cordis shall have no obligation to supply Product according to the pre-change Specification or manufacturing process.
(ii)    Cordis may make changes to the Specification and/or manufacture of the Product, outside the ranges set forth in the Specification, provided that (a) Cordis provides advance written notice to SRM of such changes, (b) Cordis provides a regulatory assessment of the changes to the specification and/or manufacture of the PRECISE® Carotid Stent System, such assessment is provided “as is,” without representations or warranties, and shall be treated as Cordis Confidential Information, and (c) Cordis provides SRM copies of engineering studies of the changes to the Specification and/or manufacture of the Product. In the case of a Cordis change pursuant to Section 2.3.1(ii) upon such written notice, SRM may within fifteen (15) days of the date of delivery of such notice, submit one (1) purchase order for up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, manufactured according to the pre-change Specification and manufacturing process, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates; except that if after using 

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commercially reasonable efforts to obtain raw materials, such raw materials are not available, Cordis shall have no obligation to supply Product pursuant to this sentence. In the event that the change pursuant to this Section 2.3.1(0) relates to a change in the Facility, SRM may within fifteen (15) days of the date of delivery of such notice, submit one (1) purchase order for Product to be manufactured according to the pre-change Specification and manufacturing process, such amount not to exceed up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates. In the case of a change pursuant to Section 2.3.1(0), except as set forth in this Section 2.3.1(0, Cordis shall have no obligation to supply Product according to the pre-change Specification or manufacturing process.
(iii)    Cordis shall provide advance notice to SRM of any proposed changes to Cordis’ methodology of conducting such regulatory assessments under Section 2.3.1(i) pursuant to Form 12364266 and Form 12553603, to permit SRM to timely evaluate any potential or actual impact of such changes on the Parties agreed-to procedure under this Section 2.3.1.
2.3.2.    SRM Changes.  If SRM requests any change to the Specification and/or manufacture of the Product, whether or not such change is within or outside of the ranges set forth in the Specification, SRM must submit the change to Cordis in writing specifying a detailed description of the change, rationale for the change, and requested date of implementation of the change.  Cordis shall review each SRM change request and either approve or reject the change request in writing within thirty (30) days of receipt of such written change request.  Specifically, any approval by Cordis to implement a change request must be done in writing signed by an authorized representative of Cordis, and shall specify a detailed description of the change and the estimated date or time period by which Cordis anticipates implementing such change.  If a change request is approved by Cordis according to this Section 2,3.2, and such change requires SRM receive approval of a Regulatory Authority, Cordis shall (i) provide to SRM any data generated by Cordis to validate a change that is required by Regulatory Authority and (ii) Cordis shall continue to supply SRM with the Product according to the pre-change Specification and manufacturing process until the earlier to occur of (a) approval of the change to the Product from a Regulatory Authority or (b) in the case that the same or similar change is submitted to a Regulatory Authority by Cordis for Cordis’ PRECISE® Carotid Stent System, upon Cordis’ receipt of approval of the change for Cordis’ PRECISE® Carotid Stent System. In the event that a similar change is submitted to a Regulatory Authority by Cordis for Cordis’ PRECISE® Carotid Stent System, and that change is approved by a Regulatory Authority before the similar change for the Product is approved by a Regulatory Authority, then Cordis will provide written notice of the approval for the Cordis PRECISE® Carotid Stent System and SRM 

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may within fifteen (15) days of the date of delivery of such notice, submit to Cordis one (1) purchase order for up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, manufactured according to the pre-change Specification and manufacturing process, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates; except that if after using commercially reasonable efforts to obtain raw materials, such materials are not available, Cordis shall have no obligation to supply Product pursuant to this sentence. Nothing herein this Section 2.3.2 or elsewhere in this Agreement shall require Cordis to implement a change request by SRM.
2.4.    Payment for Development.
2.4.1.    Payment Terms.  SRM shall pay Cordis for the Development Service in accordance with the milestones set forth in Exhibit 4 (each a “Milestone”), and the terms and conditions of this Section 2.4 (the “Development Fees”).  Upon completion of each Milestone, Cordis shall submit an invoice to SRM for payment in accordance with Exhibit 4.  In the event that the Milestones set forth in Exhibit 4 are completed within one hundred and eighty (180) days from the Effective Date of this Agreement, SRM shall pay Cordis a one-time, non-creditable bonus of [******************] for early completion of the Milestones (“Early Bonus”).  For clarity, if Cordis does not complete all Milestones within one hundred and eighty (180) days from the Effective Date of this Agreement, Cordis shall not be entitled to the Early Bonus. All invoices shall be sent to the address specified in the purchase order therefor.  All payments shall be made by direct bank transfer to an account designated by Cordis’ invoice or by check payable to Cordis. Payment terms shall be thirty (30) days from SRM’s receipt of the applicable invoice.
2.5.    Subcontracting.  Cordis may subcontract the Development Services and any other activities under this Agreement, including without limitation, to Cordis Mexico, S.A. de C.V.; provided, however, that Cordis shall at all times remain responsible for the obligations under this Agreement and for any subcontractor’s performance of any of the Development Services and any other activities under this Agreement.
3.    PRODUCT SUPPLY
3.1.    Supply for Clinical Studies.  Cordis will manufacture for, and supply to, SRM Product for use in Clinical Studies as set forth in this Section 3.1.
3.1.1.    Clinical Studies Approvals.  SRM shall be solely responsible for obtaining any governmental approvals required for carrying out the Clinical Studies.  SRM shall obtain Institutional Review Board or Ethics Committee (or equivalent, as required by Applicable Law) review and approval of all aspects of each Clinical Study.
3.1.2.    Delivery.  Upon Cordis’ completion of the Development Services, SRM may submit purchase orders for Product to be used by SRM in a Clinical Study.  For supply of Product for use in a Clinical Study, SRM shall place orders by written purchase order a minimum of will deliver Products on or before the date of delivery set forth in the purchase order.  In the event Cordis becomes aware that it may be unable to deliver any Products within the time period set forth 

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in the immediate foregoing sentence, Cordis shall promptly notify SRM, and the Parties shall cooperate to develop a delivery schedule which is mutually agreeable.
3.2.    Commercial Supply.  Cordis will manufacture for, and supply to SRM, Product for SRM’s commercial sale commencing on the anticipated approval or clearance of the Product by a Regulatory Authority for marketing of the Product in the applicable jurisdiction by SRM.  The terms and conditions for forecasts, orders and deliveries for commercial Product are set forth in Exhibit 5 attached hereto,
3.3.    Minimum Volumes.  Except as set forth in Section 3.3.1, commencing the first calendar year following the later of (i) FDA approval or clearance of the Product, or (ii) FDA approval or clearance of the SRM Neuroprotection System, SRM agrees that SRM will purchase (A) a minimum of [***********] units of Product during the first full calendar year, and (B)  minimum of [**********] units of Product annually thereafter (the “Minimum Volume”).  The Minimum Volume shall be binding on SRM until the natural expiration of the License Agreement, due to expiration of the last-to-expire of the Licensed IP, if the License Agreement remains in effect through such natural expiration, For the avoidance of doubt, Cordis may terminate this Agreement according to Section 11.2., if SRM fails to meet the Minimum Volume requirement set forth in this Section 3.3 and Section 3.3.1.
3.3.1.    Minimum Volume Exceptions.  In the case SRM is permitted to have Nitinol Device and Components, Inc. or a third party Manufacturer provide supply of Product, according to the terms and conditions set forth in Section 10.1, sentence 2, the Minimum Volume shall not apply for the calendar year(s) in which Cordis is not able to supply Product or not able to supply Product in quantities required of Cordis as set forth in Exhibit 5, Section 2, and following such calendar year(s) the Minimum Volume shall be reduced by fifty percent (50%) for the remainder of the Term of this Agreement.
4.    PAYMENT FOR SUPPLY.
4.1.    Price.  Except as otherwise provided herein, the price for supply of Products under Section 3.1 or 3.2 shall be as set forth in Exhibit 6, and shall remain firm for the Term of this Agreement.  Cordis may proportionately increase the price for supply of Product if the cost of any raw material or component used to manufacture the Product or used in the actual Product increases by five percent (5%) or greater.  The price of Product does not include the fees, costs, and expenses for the transportation of the Product.  Each calendar year, the Parties will discuss in good faith whether any changes in volumes, market conditions, and/or cost savings achieved by Cordis in manufacturing the Product (including, without limitation, any reduction in prices of raw materials and components) warrant a reduction in price to SRM, and if so, what that reduction will be for the following year.  Any reduction in price of the Product must be agreed to in writing signed by an authorized representative of Cordis.
4.2.    Invoicing; Payment.  Cordis shall submit an invoice to SRM upon shipment of Product ordered by SRM hereunder.  All invoices shall be sent to the address specified in the purchase order therefor.  All payments shall be made by direct bank transfer to an account designated by Cordis’ invoice or by check payable to Cordis. Payment terms shall be thirty (30) days from the 

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later of (i) SRM’s receipt of an invoice or (ii) SRM’s receipt of the Products.  Payment by SRM shall not constitute acceptance of the Product or impair SRM’s right of inspection.
5.    QUALITY
5.1.    Quality Assurance.  All Products supplied by Cordis shall meet the current Specifications therefor and shall be manufactured in accordance with the Specifications, Applicable Laws and QS procedures at Cordis’ Facility,
5.1.1.    Cordis shall maintain ISO 13485 status, and shall inform SRM of any changes of this status, including any changes in manufacturing site.  Cordis shall provide SRM with a copy of its ISO certification,
5.1.2.    Cordis shall maintain component and production control procedures, and environmental controls in accordance with its standard internal operating procedures.  Cordis shall qualify and approve all suppliers of components and services according to Cordis’ standard internal operating procedures.
5.1.3.    Cordis shall provide copies of all available design verification and process validation testing results that have been performed by Cordis for the Product, as set forth in Exhibit 2.
5.1.4.    Cordis shall disclose to SRM in a timely manner material warning letters or similar notices received from a Regulatory Authority relating to the Facility or FDA import alerts for products manufactured in its Facility during the Term,
5.2.    Records.  Cordis shall maintain all records necessary to comply with the QS, Specifications and Applicable Laws relating to the manufacture, packaging, testing, storage and shipment of Products for a minimum of five (5) years; provided, however, that all records relating to the manufacture, stability, and quality control of each batch of Product shall be retained until the Parties mutually agree to dispose of such records.
5.3.    Audit.  Upon reasonable written notice given by SRM to Cordis, during normal business hours, and in such a manner that does not unreasonably interfere with Cordis’ normal business activities no more than once a year or upon any action by a Regulatory Authority relative to the Product or the Facility, Cordis shall permit a third party auditor mutually agreed upon by the Parties in writing, with agreement not to be unreasonably withheld, (and then only after such third party auditor agrees in writing to the keep Cordis’ Confidential Information confidential under the terms materially the same as those incorporated in this Agreement), to access and analyze the part of the Facility used for manufacturing, production and storage of Product and Cordis’ device master, device history and quality system records relating to the manufacture of the Product (including, without limitation, batch records and SOPs), and permit such third party auditor to (i) verify compliance of Cordis with this Agreement including QS and Applicable Laws, and (ii) make quality assurance audits of the facilities and of the procedures and processes used by Cordis in manufacturing, packaging, testing, storing and shipping Products.

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5.4.    Recalls.  The Parties acknowledge and agree that Section 6.7 (Removals and Corrections (Recalls)) of the License Agreement is hereby incorporated by reference into this Agreement. SRM shall be solely responsible for communicating and retrieving Product from third party customers, that is subject to any removal, correction or other field action relating to the Product.  Prior to SRM providing written communication to a third party customer, SRM shall provide Cordis with the proposed written communication, so that Cordis may review and provide input on the content of such communication. In the event Cordis does not provide its input (i) within twenty-four (24) hours after delivery of such proposed written communication by SRM to Cordis if such notice is initially provided on or during a business day, or (ii) by the close of the first business day following delivery of such proposed written communication by SRM to Cordis if such notice is initially provided on or during a weekend or a holiday, SRM may proceed to disperse such proposed written communication.  The costs, fees, and expenses of any removal, correction or other field action relating to a Product shall be solely paid by SRM, with the exception if the removal, correction or other field action is caused by Cordis’ failure to manufacture the Product to the Specifications, Cordis shall be responsible for the reasonable costs, fees and expenses of such removal, correction or field action to the extent the removal, correction or field action is related to Cordis’ failure to manufacture the Product to the Specifications.
5.5.    Defective Product.  SRM shall notify Cordis in writing of the existence and nature of any Product that it determines does not meet the Specifications, and SRM shall return the Product with a description of the defect to Cordis, within thirty (30) days of such determination by SRM.  Cordis shall have a reasonable opportunity, not to exceed fifteen (15) business days from receipt of notification and Product, to inspect such Product. Cordis shall within forty-five (45) days replace and pay for the cost of transportation and disposition of any item that Cordis determines does not meet the Specifications or is otherwise defective.  If, after Cordis’ inspection of any Product, the Parties disagree as to whether such Product meets the Specifications, Cordis may deliver the Product to an independent third-party laboratory, mutually and reasonably acceptable to both Parties, for testing to confirm such Product’s conformance to the Specifications.  All costs associated with such third-party testing shall be at SRM’s expense unless the tested item is deemed by such third-party to not meet the Specifications, in which case all such costs, including reimbursement of transportation and disposition costs, shall be promptly paid by Cordis to SRM.
6.    REPRESENTATIONS AND WARRANTIES; DISCLAIMERS
6.1.    Mutual Representations and Warranties.  In addition to the warranties set forth in Section 8.2.2, each Party represents and warrants to the other that: (i) it is duly organized, validly existing, and in good standing in the jurisdiction in which it is incorporated, (ii) it has full corporate power and authority to carry on its business as presently conducted and as contemplated in this Agreement, to execute and deliver this Agreement, and to perform its obligations hereunder; (iii) the execution, delivery and performance of this Agreement do not and will not (A) violate any law, rule, regulation, order, decree or permit which is applicable to it or (B) violate its organizational documents or any agreement to which it is a Party; and (iv) this Agreement is a legal and binding obligation of it, enforceable against it in accordance with its terms, except to the extent enforceability is modified by bankruptcy, reorganization and other similar laws affecting the rights of creditors generally and by general principles of equity.

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6.2.    Product Representations and Warranties.
6.2.1.     Cordis.  Cordis warrants and represents that: (i) all Product supplied to SRM hereunder shall comply with the Specifications for the Product; (ii) the Facility, and all Products supplied to SRM hereunder meet Applicable Laws, Regulatory Authority’s requirements for commercialization of the Product, and QS; (iii) Development Services shall be conducted in a professional manner, with due care and in accordance with industry standards, and (iv) title to all Products supplied to SRM hereunder shall pass to SRM as provided herein free and clear of any security interest, lien, or other encumbrance.
6.2.2.    SRM.  SRM agrees that the warranty set forth in Section 6.2.1 does not include Products that have defects or failures resulting from the design of the Product, as distinct from the manufacture or workmanship thereof, including without limitation, design functionality or failures relating to the function of the Product for SRM’s intended purpose.
6.3.    DEVELOPMENT SERVICES DISCLAIMER.  OTHER THAN AS EXPRESSLY SET FORTH IN SECTIONS 2.1, 22, 5.1, AND 6.1(iii) OF THIS AGREEMENT OR SECTION 7.2 OR SECTION 7.3 OF THE LICENSE AGREEMENT, THE DEVELOPMENT SERVICES PERFORMED BY CORDIS OR BY A THIRD PARTY CONTRACTED BY CORDIS (INCLUDING THE DELIVERABLES) ARE PROVIDED TO SRM “AS IS,” AND CORDIS AND ITS DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARCULAR PURPOSE, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY.
6.4.    PRODUCT DISCLAIMER.  OTHER THAN AS EXPRESSLY SET FORTH IN SECTIONS 2.1, 22, 5.1, 6.1 AND 6.2 OF THIS AGREEMENT OR SECTION 7.2 OR SECTION 7.3 OF THE LICENSE AGREEMENT, SRM AGREES THE WARRANTIES SET FORTH IN SECTION 6.2.1 OF THIS AGREEMENT ARE THE ONLY WARRANTIES APPLICABLE TO THE PRODUCT AND CORDIS AND ITS DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY.
7.    REGULATORY MATTERS
7.1.    Adverse Events.  The Parties acknowledge and agree that Section 6.6 (Handling of Customer Complaints/Medical Device Reporting/Adverse Reaction and Device Defect Reporting) of the License Agreement is hereby incorporated by reference into this Agreement.
7.2.    Communications.  The Parties acknowledge and agree that SRM is solely responsible for filing any and all medical device reports or otherwise communicating with the FDA or any other Regulatory Authority with respect to the Products.  If SRM files any medical device report concerning the Products, it will promptly notify Cordis of its filing in writing.  If Cordis is 

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required by Applicable Laws, or a Regulatory Authority to disclose information directly to such Regulatory Authority, Cordis shall promptly notify SRM in writing of the requirement and the particulars of the information required to be disclosed prior to such disclosure, and shall provide SRM copies of all information and materials provided to such authorities and summaries of communications with such authorities. Further, each Party shall have the right to be present and to participate at all face-to-face meetings and scheduled conference calls between the other Party and such Regulatory Authority or any Facility inspections with respect to the manufacturing of the Products under this Agreement.
7.3.    Government Inspection.  As it pertains to the manufacture of Products by Cordis, (i) Cordis shall permit the FDA and other Regulatory Authorities, as applicable, to conduct such inspections of the Facility as such authority may request, and shall cooperate with the Regulatory Authorities with respect to such inspections and any related matters, (ii) Cordis shall give SRM reasonable notice of any scheduled inspections, and notice within twenty four (24) hours after any unannounced visit or inspection by any Regulatory Authority, (iii) to the extent practical under the circumstances, Cordis shall allow SRM or its representative to assist in the preparation for and be present at such inspections, (iv) Cordis shall keep SRM informed about the results and conclusions of each such Regulatory Authority inspection, including actions taken by Cordis to remedy conditions cited in such inspections, and (v) Cordis shall promptly provide SRM with copies of any written inspection reports issued by such Regulatory Authority and all correspondence between Cordis and the Regulatory Authority involved, including, but not limited to, FDA Form 483 and all correspondence relating thereto.
8.    COMPLIANCE.
8.1.    General Compliance with Laws.  Each Party agrees to exercise commercially reasonable efforts to the extent required by law to materially comply with the applicable provisions of any Federal or state law and all executive orders, rules and regulations issued thereunder, whether now or hereafter in force, including Executive Order 11246, as amended, Chapter 60 of Title 41 of the Code of Federal Regulations, as amended, prohibiting discrimination against any employee or applicant for employment because of race, color, religion, sex or national origin; Section 60-741.1 of Chapter 60 of 41 Code of Federal Regulations, as amended, prohibiting discrimination against any employee or applicant for employment because of physical or mental handicap; Section 60.250.4 of Chapter 60 of 41 Code of Federal Regulations, as amended, providing for the employment of disabled veterans and veterans of the Vietnam era; Chapter 1 of Title 48 of the Code of Federal Regulations, as Amended, Federal Acquisition Regulations; Sections 6, 7 and 12 of the Fair Labor Standards Act, as amended, and the regulations and orders of the United States Department of Labor promulgated in connection therewith; and any provisions, representations or agreements required thereby to be included in this Agreement are hereby incorporated by reference.
8.2.    Healthcare Compliance Laws and Policies.  No part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are any payments, or contributions of free products intended to induce illegal referrals of business.  Each Party shall exercise commercially reasonable efforts to materially comply with laws, regulations, including safe harbor regulations, and official guidance 

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pertaining to state and federal anti-kickback laws (42 U.S.C. §§ 1320a-7b, et seq. and its implementing regulations), and laws prohibiting the submission of false claims to governmental or private health care payors (31 U.S.C. §§ 3729, et seq. and its implementing regulations), and the Limitation on Certain Physician Referrals, also referred to as the “Stark Law” (42 U.S.C. 1395 (n)).  SRM represents and warrants that it understands and agrees that it shall use commercially reasonable efforts to ensure that the sale, distribution, and marketing of Product by SRM and its representatives shall be performed in material compliance with all laws and regulation, including, but not limited to, those healthcare related laws and regulations provided in this Section 8.2.  Each Party shall be responsible for using commercially reasonable efforts to materially for (i) ensuring that its employees, agents, representatives, independent contractors, officers and directors comply with the requirements of this Section 8.2, including conducting training as necessary, (ii) establishing a process for SRM and its employees, agents, representatives, independent contractors, officers and directors to report any violations of the compliance requirements set forth in this Section 8.2, and (iii) reporting any such compliance violations.  Any and all material violations must be reported by SRM to Cordis by calling 1-800-556-2596, and by Cordis to SRM, by calling 1-408-720-9002 extension 101, as the case may be.
8.2.1.    Patient and Individual Privacy Protections.
8.2.1.1.    Protected Health Information under HIPAA.  In the event that the investigation of Product complaints or other information about the Product involves the use or disclosure of Protected Health Information (as defined under the United States HIPAA Privacy Requirements) by health care providers, the Parties shall use commercially reasonable efforts to ensure that the use of the Protected Health Information materially complies with any HIPAA Privacy Requirements that apply to such Protected Health Information.  The “HIPAA Privacy Requirements” refer collectively to the applicable provisions of the Administrative Simplification section of HIPAA - the Health Insurance Portability and Accountability Act of 1996 (as codified at 42 U.S.C. § 1320d-8) and any regulations promulgated thereunder, including without limitation, the federal privacy regulations (45 CFR Parts 160 and 164) and the federal security standards (45 CFR Part 142).
8.2.1.2.    Consent to Use and Disclose Information.  In the event that the services provided under this Agreement involve direct interactions with patients, consumers or caregivers, SRM shall obtain written consent from any such persons providing Cordis the right to use and disclose the information collected from such persons.
8.2.2.    Debarment.  Each Party warrants that to the best of its knowledge and belief, it and its employees, agents and subcontractors are: (i) not excluded from a United States federal health care program as outlined in Sections 1128 and 1156 of the United States Social Security Act (see the Office of Inspector General of the Department of Health and Human Services List of Excluded Individuals/Entities at http://www.oig.hhs.gov/FRAUD/exclusions/listofexcluded.html); (ii) not debarred by the FDA under 21 United States Code 335a (see the FDA Office of Regulatory Affairs Debarment List at http://www.fda,gov/orakompliance ref/debar/); (iii) otherwise not excluded from contracting with the federal government (see the Excluded Parties Listing System at http://epls.arnet.gov); and (iv) if required, duly licensed and in good standing in 

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accordance with applicable state laws to perform its obligations under this Agreement.  In addition, the Parties agree to use commercially reasonable efforts to materially comply with all applicable laws, rules and regulations, including the federal anti-kickback stature (42 United States Code §§ 1320a-7(b)) and the related safe harbor regulations.  These shall be ongoing representations and warranties during the Term of this Agreement and each Party shall immediately notify the other Party of any change in the status of the representations and warranties set forth in this Section.
8.3.    Foreign Corrupt Practices Act.  In connection with this Agreement or the License Agreement, each Party will exercise commercially reasonable efforts to materially comply fully with the U.S. Foreign Corrupt Practices Act (“FCPA”) and the substantive provisions of applicable anti-bribery legislation, specifically those that were enacted to implement the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions dated November 21, 1997, as well as any amendments thereto (“Convention”).  Each Party will not make any payments or offers to pay anything of value to any government official in contravention of the FCPA or the Convention.  If at any time during the Term of this Agreement, either Party learns that any foreign government official (i) owns an interest in or is an officer, director or employee, agent, representative or independent contractor of such Party, or (ii) has any legal or beneficial interest in payments to be received by such Party hereunder, such Party will notify the other Party and take actions to ensure that such government official does not take any action, official or otherwise, and/or use any influence in connection with the other Party’s business.  Each Party warrants that it has not and will not pay or offer, directly or indirectly, any commission or finders or referral fee to any person or entity in connection with its activities under this Agreement unless it has obtained prior written approval from the other Party.
9.    PROPERTY RIGHTS; LICENSES; CORDIS DE MEXICO CONFIDENTIAL INFORMATION
9.1.    SRM Materials.  Other than as provided in Section 5 of the License Agreement, SRM shall retain all right, title and interest in and to the Specifications, designs, drawings, blueprints, paid for by SRM in connection with this Agreement or the License Agreement (collectively, the “SRM Materials”); and to the extent that Cordis would otherwise have any interest in or to the SRM Materials, Cordis hereby irrevocably transfers, conveys and assigns to SRM, and its successors and assigns, all right, title, and interest in and to the SRM Materials.  Cordis agrees to execute such documents and take such other actions as SRM may reasonably request to evidence and perfect the foregoing.  For the avoidance of doubt, SRM agrees that notwithstanding that SRM has all right, title and interest to the SRM Materials, SRM has no right to practice, duplicate or otherwise use Cordis Technology or Cordis Confidential Information contained in or incorporated by reference in SRM Materials, except to the extent permitted by the License Agreement and only for the period that the License Agreement is in effect.  Accordingly, SRM agrees that unless permitted by the License Agreement, SRM is prohibited from practicing, duplicating, or otherwise using the Cordis Technology or Cordis Confidential Information that is contained in such SRM Materials,
9.2.    License to Cordis.  In addition, to Section 5 of the License Agreement, SRM hereby grants to Cordis a non-exclusive, nontransferable license to the SRM Property solely to perform the Development Services and manufacture the Products ordered by SRM hereunder and 

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deliver such Products to SRM or its designee as specified in this Agreement.  For purposes of the foregoing, “SRM Property” shall mean SRM Materials, confidential information, data and such other intellectual property rights (including patent rights) owned or controlled by SRM during the Term of this Agreement, to the extent related to the development and manufacture of the Product.
9.3.    Cordis Mexico Confidential Information.  SRM recognizes and agrees that all information provided by Cordis Mexico to SRM shall be receive the same treatment as Cordis Confidential Information, as required by Section 9 of the License Agreement, Similarly, Cordis shall cause Cordis Mexico to be compliant with SRM Confidential Information as required by Section 9 of the License Agreement.
10.    THIRD PARTY MANUFACTURE AND FAILURE TO SUPPLY
10.1.    Third Party Manufacturer.  Notwithstanding the terms and conditions of Section 6.1(a) of the License Agreement, Cordis shall be the sole manufacturer of the Product during the Term of this Agreement, unless (i) Cordis fails to supply Product, as set forth in Section 10.2, (ii) Cordis provides written notice to SRM that it cannot meet SRM’s requirements of supply of Product, (iii) Cordis is not able or willing to make the improvements, modifications or changes to the Product requested by SRM according to the terms and conditions of Section 2.3.2, (iv) the Cordis facility is subject to a consent decree or injunction which materially adversely affects Cordis’ ability to supply SRM Product pursuant to the terms of this Agreement, or (v) the PRECISE® carotid stent is subject to an investigation or enforcement action by a Regulatory Authority or has been recalled, in either case in a way that materially adversely affects Cordis’ ability to supply SRM pursuant to the terms of this Agreement.  If any of the foregoing situations occurs, upon SRM’s election, (A) Cordis shall permit Nitinol Devices and Components, Inc. or a third party Manufacturer to provide supply of Product to SRM in accordance with Section 6.1 of the License Agreement, and (B) Cordis shall remain a manufacturer and supplier of Product to SRM under Sections 10.1(i)-(iii) to the extent Cordis is able to do so, even if Nitinol Devices and Components, Inc. or a third party Manufacturer is permitted also to supply product to SRM under Section 10.1(A).  If this Agreement is terminated by SRM according to Section 11.3.2 or by SRM or Cordis according to Section 11.3.3, or if Cordis terminates this Agreement for breach according to Section 11.2, or if, under subsection (v) of this Section, further manufacture by Nitinol Devices and Components, Inc. or a third party Manufacturer would not be legally permissible due to the nature of the investigation, enforcement action or recall (but only to the extent of the duration of the impermissibility), SRM shall not be permitted to have Nitinol Devices and Components, Inc. or a third party Manufacturer manufacture Product.  For the avoidance of doubt, and notwithstanding anything in this Agreement to the contrary, the Parties acknowledge and agree that SRM, without Cordis’ consent, may work directly with Nitinol Devices and Components, Inc. for the development and supply of next-generation products that materially expand or change the Specifications herein.
10.2.     Failure to Supply.  If Cordis fails to supply at least seventy five (75%) of the quantities of Product set forth in purchase orders for two (2) consecutive calendar quarters in accordance with either of Section 3.1 or Section 3.2 of this Agreement, then SRM shall seek supply from Nitinol Devices and Components, Inc. or a third party Manufacturer if Nitinol Devices and Components, Inc. is not able to manufacture, and in either case only with the advanced written 

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consent of Cordis, with such consent not to be unreasonably withheld as provided in Section 6.1(a) of the License Agreement, Subject to Section 11.3.1, nothing in this Section 10.2 shall amend or revise SRM’s obligation to pay Cordis the Development Fees for the Development Services performed by Cordis, as set forth in Section 2.4 of this Agreement.
11.    TERM
11.1.    Term.  This Agreement shall commence on the Effective Date and shall continue in full force and effect until earlier to occur of (a) termination as provided in this Article 11, (b) termination of the License Agreement pursuant to the terms of the License Agreement, (c) the Parties mutually agree in writing signed by an authorized representative of each Party, to terminate this Agreement, or (d) upon election by SRM if and when Cordis approves another Manufacturer in accordance with Section 10.1 or 10.2 of this Agreement (the “Term”).
11.2.    Termination by Either Party for Cause or for Insolvency.  This Agreement may be terminated prior to the expiration of the Term, by written notice stating the grounds of termination, by either Party to the other Party, without payment of penalty or damages by the Party giving such notice, at any time during the Term of this Agreement: (a) if the other Party is in material breach of its obligations hereunder and has not cured such breach within thirty (30) days after written notice requesting cure of the breach (in the event the breach is cured within such thirty (30) day period the termination shall be of no effect), or (b) upon the filing or institution of bankruptcy, liquidation or receivership proceedings, provided, however, in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if such other Party consents to the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the filing thereof.
11.3.    Other Termination Rights.
11.3.1.    Cordis.  Cordis may terminate this Agreement without penalty or damages upon One Hundred Eight (180) days’ prior written notice if (i) Cordis will no longer manufacture and/or sell the Cordis PRECISE carotid stent, or (ii) Cordis reduces capacity of its production facilities in a manner that materially impairs Cordis’ ability to supply to SRM Product in accordance with this Agreement, or (iii) Cordis permits Nitinol Devices and Components, Inc. or a third party Manufacturer to manufacture the Product pursuant to the terms of Section 10.1(iv) and 10.1(v) of this Agreement, provided that if either (i) and/or (ii) and/or (iii) occurs any time prior to (a) the first anniversary of the Effective Date, Cordis shall reimburse SRM for One Hundred Percent (100%) of the fees paid by SRM pursuant to Section 2.4, (b) the second anniversary of the Effective Date, Cordis shall reimburse SRM for Seventy Five Percent (75%) of the fees paid by SRM pursuant to Section 2.4 of this Agreement, or (c) the third anniversary of the Effective Date, Cordis shall reimburse SRM for Fifty Percent (50%) of the fees paid by SRM pursuant to Section 2.4 of this Agreement
11.3.2.    SRM.  SRM may terminate this Agreement sixty (60) days after written notice to Cordis in the event that SRM determines (i) it is not commercially reasonable to continue to pursue regulatory clearance or approval of the Product, (ii) the Product does not receive 

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approval or clearance by a Regulatory Authority or such approval or clearance is withdrawn, or (iii) it will discontinue sale of Products.
11.3.3.    Termination for Regulatory Reasons.  Either Party may terminate this Agreement without penalty or damages in the event that regulatory clearance or approval in either the U.S. or the European Union is revoked, such revocation to constitute a presumption that the Product design is deemed unsafe.
11.4.    Effect of Expiration or Termination and Survival.  Expiration or termination of this Agreement shall not relieve either Party of any obligation of such Party accruing prior to such termination.  Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other Party which accrued or is accruing under this Agreement prior to expiration or termination.  The provisions of Article 1 (Definitions), Article 4 (Payment for Supply), Section 5.2 (Records), Section 5.3 (Audit) (for one year after termination), Section 5.4 (Recalls), Article 6 (Representations and Warranties; Disclaimers), Article 7 (Regulatory Matters), Article 8 (Compliance), Section 9.1 (SRM Materials), Section 9.3 (Cordis Mexico Confidential Information), Sections 11.2 —11.6 (Term), Article 12 (Indemnification), Article 13 (Insurance; Limitation on Damages) and Article 14, (Miscellaneous) survive expiration or termination of this Agreement as specified herein.
11.5.    Transition.  Upon termination of this Agreement pursuant to Section 11.3.1 and upon SRM’s request, Cordis shall, in accordance with the terms and conditions of this Agreement, permit SRM to within thirty (30) days of delivery of Cordis’ notice, to place one (1) purchase order for up to twelve (12) months of forecast (the forecast as described in Exhibit 5, Section 1) Product times 1.5 units, manufactured according to the pre-change Specification and manufacturing process, such twelve (12) month period shall begin the next immediate month following the date of notice and continue for the next eleven (11) months, and such Product to be delivered by Cordis to SRM, three (3) months, six (6) months, and nine (9) months following Cordis’ receipt of a purchase order, and each Product shall have upon Cordis shipment to SRM, a minimum use by date remaining of twenty-three (23) months.  In addition, to the extent manufacturing is permitted to move to Nitinol Devices and Components, Inc. or a third party Manufacturer in accordance with Section 6.1 of the License Agreement, Cordis and SRM shall work together to ensure orderly transition of the manufacturing responsibilities at SRM’s cost and expense.  For the avoidance of doubt, SRM shall bear the cost and expense of directly billed fees from Nitinol Devices and Components, Inc. or a third party Manufacturer in connection with establishing manufacturing capabilities and supply of Product, and Cordis will provide, at its cost and expense, reasonable transition assistance in accordance with Section 6.1(b) of the License Agreement, but only if the License Agreement is in effect,
11.6.    Excess and Obsolete Inventory.  Any reasonable inventory (including raw materials, components, work-in-process, or Product) or orders for components and raw materials which are non-cancelable, non-returnable, and otherwise non-usable (including by Cordis or its affiliates for purposes of manufacturing products other than Product) that were ordered by Cordis or its affiliates pursuant to binding orders and are rendered excess or obsolete due to (i) termination of this Agreement by Cordis for SRM’s breach of this Agreement as set forth in Section 11.2, or 

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(ii) termination of this Agreement by either Cordis or SRM according to Section 11.3.2 or 11.3.3 of this Agreement, or (iii) to the extent of the cancellation of one or more of SRM’s purchase orders by SRM without cause, will be the sole financial responsibility of SRM.  SRM shall make payment to Cordis for all excess and obsolete inventory set forth in this Section, upon thirty (30) days of Cordis’ delivery of an invoice.
12.    INDEMNIFICATION
12.1.    SRM.  SRM shall indemnify, defend and hold harmless Cordis, its directors, officers, employees, agents, successors and assigns (the “Cordis Parties”) from and against any liabilities, expenses or costs (including reasonable attorneys’ fees and court costs) (“Damages”) arising out of any claim, complaint, suit, proceeding or cause of action against any of them by a third party, including a claim of patent infringement (“Claim”) resulting from (i) the design of the Product, (ii) the use of the MICHI Neuroprotection System; (iii) the use of the Product; (iv) the negligent or intentionally wrongful acts or omissions of SRM, its affiliates, or their directors, officers, agents, employees or consultants; (v) any breach by SRM of Section 8 or its representations and warranties in this Agreement; in the case of (iv) and (v) except to the extent any such Damages arise from, are caused by, or aggravated by the negligent or intentional misconduct of Cordis, the Cordis Parties, or Cordis’ indemnification obligations in Section 12.2.
12.2.    Cordis.  Cordis shall indemnify, defend and hold harmless SRM, its directors, officers, employees, agents, successors and assigns (the “SRM Parties”) from and against all Damages arising out of any Claim resulting from (i) the manufacture or supply of Product that fails to meet the Specifications, Applicable Laws, QS, or the requirements of this Agreement, (ii) the negligent or intentionally wrongful acts or omissions of Cordis, its affiliates, or their directors, officers, agents, employees or consultants; (iii) infringement of third party process intellectual property in the provision of Development Services or manufacture of Product; and (iv) any breach by Cordis of any of its representations and warranties or Section 8 of this Agreement; each of (i) — (iv) except to the extent any such Damages arise from, are caused by, or aggravated by the negligent or intentional misconduct of SRM, the SRM Parties, or SRM’s indemnification obligations in Section 12.1.
12.3.    Indemnification Procedure.  Any Cordis Party or SRM Party seeking indemnification under this Article 12 (the “Indemnitee”) shall promptly notify the indemnifying Party (the “Indemnitor”) in writing of such claim, including a detailed description of the claim (the “Indemnity Claim”).  The Indemnitor shall have the right to participate jointly with the Indemnitee in the Indemnitee’s defense, settlement or other disposition of any Indemnity Claim.  With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the Indemnitee becoming subject to injunctive or other equitable relief or otherwise adversely affecting the business of the Indemnitee in any manner, and as to which the Indemnitor shall have acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the Indemnitor shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the Indemnitor, in its sole discretion, shall deem appropriate, provided that the Indemnitor shall not enter into an agreement or settlement which requires the Indemnitee to admit to guilt, liability or wrongdoing of any kind and further providing that the Indemnitor shall provide reasonable evidence 

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of its ability to pay any damages claimed and with respect to any such settlement shall have obtained the written consent of the Indemnitee from the Indemnity Claim.  The Indemnitor shall obtain the written consent of the Indemnitee prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim if as a result thereof the Indemnitee would become subject to injunctive or other equitable relief or the business of the Indemnitee would be adversely affected in any manner,
13.    INSURANCE; LIMITATION ON DAMAGES.
13.1.    Insurance.  Prior to commencing human clinical trials in the United States with the Product, SRM shall, at its own expense, obtain and maintain , (i) product liability insurance providing protection in the amount of at least Three Million Dollars ($3,000,000) in annual aggregate against any claims, suits, losses or damages based upon any alleged defect in, or otherwise caused by, any Products purchased pursuant to this Agreement and (ii) general liability insurance providing protection in the amount of at least Three Million Dollars ($3,000,000) in annual aggregate against any claims, suits, losses or damages based upon any act or alleged activity of a Party pursuant to this Agreement.  Upon FDA clearance of the latter of the Product or the SRM Neuroprotection System, SRM shall, at its own expense, obtain and maintain (i) product liability insurance providing protection in the amount of at least Five Million Dollars ($5,000,000) in annual aggregate against any claims, suits, losses or damages based upon any alleged defect in, or otherwise caused by, any Products purchased pursuant to this Agreement and (ii) general liability insurance providing protection in the amount of at least Five Million Dollars ($5,000,000) in annual aggregate against any claims, suits, losses or damages based upon any act or alleged activity of a Party pursuant to this Agreement.  When SRM’s annual revenue of the Product exceeds Fifty Million Dollars ($50,000,000), SRM shall at its own expense, obtain and maintain (i) product liability insurance providing protection in the amount of at least Ten Million Dollars ($10,000,000) in annual aggregate against any claims, suits, losses or damages based upon any alleged defect in, or otherwise caused by, any Products purchased pursuant to this Agreement and (ii) general liability insurance providing protection in the amount of at least Ten Million Dollars ($10,000,000) in annual aggregate against any claims, suits, losses or damages based upon any act or alleged activity of a Party pursuant to this Agreement.  SRM shall maintain insurance as defined above throughout the Term of this Agreement and for a period of time thereafter for three (3) years or the shelf life of the Product, whichever is longer. SRM shall furnish to Cordis upon request and at least annually a Certificate of Insurance evidencing compliance with the provisions of this Section 13.1.  The existence of such coverage shall in no way limit a Party’s liability or obligations hereunder this Agreement.
13.2.    LIMITATION ON DAMAGES.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY PUNITIVE, EXEMPLARY, MULTIPLIED, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, PERSONAL INJURY AND PROPERTY DAMAGE, LOSS OF PROFITS OR REVENUES, AND EACH PARTY HERBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES, IN ADDITION, NO PARTY SHALL BE AWARED ANY MULTIPLIER TO ANY AWARD OF ACTUAL DAMAGES, EXCEPT AS REQUIRED BY STATUTE,

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14.    MISCELLANEOUS.
14.1.    Incorporation of License Agreement.  The applicable provisions of the License Agreement, including, without limitation, Articles 1 (Definitions), 2 (License Grants), 5 (Ownership and Prosecution of Patent Rights), 6 (Cooperation between Parties), 8 (Commercialization; Use of Names), 9 (Confidentiality), 10 (Right of First Negotiation), 11 (Transferability) (excluding Section 11.6), 12 (Termination), 13 (Dispute Resolution), and 14 (General excluding Section 14.1 (Integrated Agreement)) are hereby incorporated into this Agreement by reference and are binding on the Parties with respect to this Agreement.
14.2.    Entire Agreement.  This Agreement, together with the License Agreement between the Parties, constitutes the complete and exclusive statement of the agreement between the Parties, and supersedes all prior agreements, proposals, negotiations and communications between the Parties, both oral and written, regarding the subject matter hereof.  The language and terms of this Agreement and the License Agreement are intended to complement, supplement and be consistent with one another.  In case there is a conflict between any of the terms of the two Agreements, the language of the License Agreement shall control.

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IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly authorized representatives, to be effective as of the Effective Date.
	
					
	CORDIS CORPORATION
	 
	SILK ROAD MEDICAL, INC.

	 
	 
	 
	 
	 

	By:
	/s/ Jose A. Gonzalez
	 
	By:
	/s/ William Worthen

	Print:
	Jose A. Gonzalez
	 
	Print:
	William Worthen

	Title:
	VP OPS
	 
	Title:
	President & Chief Executive Officer

	Date:
	10/21/2011
	 
	Date:
	9/21/2011

Exhibit 1: Design Inputs
The design will include a shortened working length of the PRECISE® Carotid Stent System for transcervical implantation of the PRECISE® carotid stent, The design shall refer exclusively to a stent delivery system with a working length of 65 centimeters, The design will include validated packaging, package labeling, and sterilization, The design will include diameters and lengths as outlined in the table following:

	
		
	Stent Length(mm)
	Stent Diameter(mm)

	20
	5

	20
	6

	20
	7

	20
	8

	20
	9

	20
	10

	30
	5

	30
	6

	30
	7

	30
	8

	30
	9

	30
	10

	40
	5

	40
	6

	40
	7

	40
	8

	40
	9

	40
	10

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Exhibit 2: Design and Development Plan
SECTION 1 - PROJECT SCOPE AND APPROACHES
PRODUCT DESCRIPTION
New design consists of a shortened working length of the Precise Carotid Stent System. Application and clinical indication is determined by SRM,
PROJECT SCOPE
Under the scope of this project Cordis will create and release 18 new Carotid Stent Delivery System catalogs - 65cm length. These include combinations of six (6) stent diameters (5, 6, 7, 8, 9 and 10 mm) and three stent lengths (20mm, 30mm and 40 mm),

	
		
	Stent Length(mm)
	Stent Diameter(mm)

	20
	5

	20
	6

	20
	7

	20
	8

	20
	9

	20
	10

	30
	5

	30
	6

	30
	7

	30
	8

	30
	9

	30
	10

	40
	5

	40
	6

	40
	7

	40
	8

	40
	9

	40
	10

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Product tray will be qualified in as part of development of the product.
MANUFACTURING SITE
New Carotid Stent Delivery System catalogs with 65cm length assembly and packaging will be performed at Cordis de Mexico, Sterilization will be performed at Steris Isomedix Inc. sterilization facilities in El Paso, Texas,
FUNCTIONAL REPRESENTATIVES
	
			
	Team Member
	Roles
	Responsibilities

	OETS (Sustaining) / Operations

	James Merrit
	OETS (Sustaining) Director
	Overall Project Leadership.

	Victor Baylon
	OETS (Sustaining) Manager
	Project Manager. Provide input for this D&D plan.

	Laura Gisela Rico
	Lead) ETS (Sustaining) Engineer (Project Leader)
	Project leader. Plan and execute key activities as per this D&D plan.

	Laura C. Irigoyen
	OETS (Sustaining) Engineer
	Provide project support.

	Fabio Diaz
	OETS (Sustaining) Engineer
	Provide project support,

	Iris Castillo
	OETS (Sust/Contractor) - Packaging Engineer
	Provide project support in the area of packaging. Plan and execute key packaging related activities as per this D&D plan.

	Antolin Salazar
	OETS (Sustaining) Technician
	Provide project support.

	Victor Baylon
	Packaging Manager
	Overall Packaging Leadership

	Yipsi Bowley
	OETS (Sustaining) Engineer R&D Manager
	Provide Design Control support. Provide input for this D&D plan.

	R&D 

	Scott Jones
	R&D Engineer
	Provide support for planning & execution of Design Verification/Validation as per this D&D plan.

	Quality Assurance
	 
	 

	Nancy Amaya
	QA Director
	Overall QA leadership

	Hector Medrano
	QA Manager
	QA project management. Provide input into this D&D plan.

	Adriana Gamez
	PQS/FAL Manager
	Provide support/direction for this D&D Plan

	Sergio Muftoz
	QA Engineer
	QA Support

	Operations
	 
	 

	Karla Perea
	Mfg Manager
	Operations Management,

	Juan Carlos Gallegos
	Mfg Eng Ops
	Provide project support.

	Ignacio Arroniz
	Packaging Engineer
	Provide project support in the area of packaging, Plan and execute packaging related activities as per this D&D plan,

	Cross-Functional Support

	Sam Mirza
	Regulatory Affairs Manager
	Overall Regulatory Affairs project management, provide input for Regulatory Approach

	Independent Peers

	Shawn Kallivayalil
	R&D Mgr
	Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan

	Araceli Muiloz
	QA Engineer
	Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan

	Carlos Hem
	OPS Engineer
	Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan

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Design & Development APPROACHES
Marketing
Marketing Objectives
Responsibility of SRM.
Volume Expectations
Demand expected is according to SRM Planning, current forecast as follows:

	
								
	unit forecast as of 2/2/11

	 
	2011
	2012
	2013
	2014
	2015
	2016
	2017

	Scenario 1
	[***]
	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

	Scenario 2
	[***]
	[***]
	[***]
	[***]
	[***]
	[***]
	[***]

Note: Forecast may be revised in a subsequent revision of this Design and Development Plan.
Pricing Strategy
Pricing for final customer is managed by SRM.
Branding Name Strategy
Branding name strategy for 18 new Carotid Stent Delivery System catalogs - 65cm length will be selected by SRM.
Initial Sales Forecast and ISS Requirements
[*********] units will be manufactured as the Initial Shelf Stock (ISS) requirement for product launch. Manufacture and delivery of ISS is not included in Development Fees, SRM shall place a written purchase order for the ISS, the price of which is [********] per unit.
Desired Clinical Indications
To be determined by SRM (not part of this plan)
Desired Performance Claims
To be determined by SRM (not part of this plan)
Key Marketing Activities
To be determined by SRM (not part of this plan)
Regulatory
Distribution Region
To be determined by SRM (not part of this plan)
Regulatory Classification
To be determined by SRM (not part of this plan)

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Submission Type
To be determined by SRM (not part of this plan)
Regulatory Pathway
To be determined by SRM (not part of this plan)
Promotional Claims
To be determined by SRM (not part of this plan)
Import/Export Requirements:
To be determined by SRM (not part of this plan)
Testing Requirements
As determined by Cordis, Cordis will leverage the TDI’s corresponding to the PMA approved PRECISE products marketed by Cordis, except those that are specific to the new length (65 cm), which will be performed for the new length as set forth in the section Product Design Verification of this Design and Development Plan. Testing related to simulated use must be responsibility of SRM; since the clinical application of this product will be developed and validated by SRM.
Operations Planning
Carotid Stent Delivery System catalogs with 65cm length validation, such activities specified in this agreement will be managed per Cordis Quality System,
Design Reviews 
The following Technical Design Reviews (TDR) will be completed by Cordis for the carotid stent delivery system catalogs with 65cm length project:
		
	•
	Design Review I: Combined Design Input, Concept Selection and Planning & Design Output Technical Design Review (Prototypes testing completed)

		
	•
	Design Review II: Combined Verification/Validation and Design and Technology Transfer Technical Design Review (DV/PPQ Report approved)

Evidence of completion of Design Review I and Design Review II will be document as required per Cordis Quality System,
A Clinical Readiness Design Review is responsibility of SRM and will not be documented in the Cordis Quality System,
Design History File
A new electronic DHF will be created by Cordis for the 18 new Carotid Stent Delivery System catalogs - 65cm length project to allow for development and release of new documentation for these codes.

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Risk Assessment and Mitigation 
SRM is responsible for the risk management plan documentation required for 18 new Carotid Stent Delivery System catalogs - 65cm length due to new application (transcervical approach).
Concept Evaluation and Selection — Product & Package
Concept Generation
Cordis will manufacture the product and SRM will brand the product.
Prototyping Activities
Prototypes will be run by Cordis as a pre-requisite of the Design Verification/Product Performance Qualification. A summary of these evaluations, including reliability analysis of the testing done will be captured in an engineering report written by Cordis and provided to SRM.
Design Assessments
There is neither animal testing nor customer use feedback from Cordis for the 18 new Carotid Stent
Delivery System catalogs - 65cm length. Clinical trial is responsibility of SRM,
Test Method Development
Existing Cordis Test Methods will be used by Cordis to assess the change in the length of the 18 new Carotid Stent Delivery System catalogs - 65cm. If any test method is not applicable based on the SRM intended use, technical design input must be addressed by SRM,
Design Characterization
Design Characterization Activities
A tolerance stack up analysis will be done by Cordis to determine lengths for the 18 new Carotid Stent Delivery System catalogs - 65cm length components, Outer Member, Support Member, and their components. This stack up analysis will be used to determine dimensions for the components and for the packaging.
Key design elements not being modified or impacted as a result of the 65cm product include the stent, SDS, packaging (except product tray), as existing components will be utilized and there is no change or impact at the manufacturing/process level. Changes will be done only to remove the Cordis and J&J branding.
Anticipated Design Iterations and Contingencies
There are no planned design iterations and contingencies.
Product Design Verification
Technical Design Inputs (TDIs) affected by the change on the length (65cm) will be tested by Cordis for the 18 new SRM Carotid Stent Delivery System catalogs - 65cm length project and will be based 

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on length modification and size bracketing strategy., The only TDIs that Cordis will test are as follows:
		
	•
	Usable length

		
	•
	Exit port location

		
	•
	MB Positioning

		
	•
	Stent pre-deployment

		
	•
	OM stroke length

		
	•
	OM hub pull strength

		
	•
	OM Proximal OM Body elongation pull strength

		
	•
	Wire lumen/Proximal wire/PET Sleeve pull strength

		
	•
	SM distal hypotube/proximal wire pull strength

		
	•
	Coil Stop pull strength

		
	•
	Labeling content

For the avoidance of doubt, SRM will test TDIs for trackability and deployment force. Cordis will provide to SRM the following information (i) test method parameters and acceptance criteria Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force and which Cordis determines are applicable to the Product, and (ii) sample sizes Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force; so that SRM can develop and validate its own test methods for trackability and deployment force. Manufacture units for trackability and deployment force testing are included in the scope of the Development Fees up to the maximum number of units set forth in Exhibit 3 of the Supply Agreement.
For the avoidance of doubt, TDIs that will not be tested by Cordis for the 18 new Carotid Stent Delivery System catalogs - 65cm length project are:
		
	•
	Crossing profile

		
	•
	Luer fitting

		
	•
	Air embolization

		
	•
	Ability to aspirate

		
	•
	Wire lumen ID

		
	•
	SDS Tip TD

		
	•
	Deployment accuracy

		
	•
	OM hub/hemovalve joint torque

		
	•
	Pod/body fuse joint pull strength & elongation

		
	•
	Brite tip/pod fuse joint strength

		
	•
	Hub/hypotube pull strength

		
	•
	Hub/proximal wire pull strength

		
	•
	Wire lumen tip pull strength

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Design Verification (DV) & Product Performance Qualification (PPQ) for the 18 new Carotid Stent Delivery System catalogs - 65cm length will be combined and will address qualification of the product. DV/PPQ units will be subjected to three EtO sterilization cycles.
Stability is not required as this product does not contain drug.
Packaging Design Verification 
Design Verification related to packaging are the impacted TDI’s related to the tray only. The only TDIs associated with the tray that Cordis will tested as part of the Design Verification for packaging are:
		
	•
	Product Migration

		
	•
	Product Visual Inspection

		
	•
	Packaging Integrity Test (Visual Inspection)

		
	•
	Package Challenge Test (Bubble Test)

		
	•
	Dye Penetration Test

		
	•
	Seal Pull Test

DV & PPQ for the packaging will be combined. DV/PPQ units will be subjected to three EtO sterilization cycles.
No aging testing will be performed by Cordis for the 18 new Carotid Stent Delivery System catalogs - 65cm length project.
Quality
Quality is addressed through Cordis Quality System.
Design Validation — Product/Package
Product
The Carotid Stent Delivery System catalogs with 65cm length will be manufactured for SRM.
Design Validation for SRM intended use of the product is responsibility of SRM.
Product labeling dimensions are:
		
	•
	Outer label: 5.625” x 9.625”

		
	•
	Inner label: 5.25” x 8.825”

SRM to provide label content to Cordis, Fasson Trans-Therm 2 material to be used by Cordis. No aging testing will be performed by Cordis for the 18 new Carotid Stent Delivery System catalogs -65cm length labeling.

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SRM to provide to Cordis artwork and content for both instructions for use and stent implant card for the DV/PPQ. For the avoidance of doubt, SRM is solely responsible for ensuring that the artwork and content of the instructions for use and stent implant card meet the requirements of all laws and regulations.
Cordis will purchase the materials for the instructions for use and stent implant card, which will fabricated by using the existing qualified Cordis specification (dimensions, materials, weight.)
No clinical trial will be done by Cordis to support the 18 new Carotid Stent Delivery System catalogs - 65cm length.
Process Validation
Project approach to Process Validation will be done according to Cordis Quality System,
Sterilization 
The Sterilization strategy is to be 3X EtO capable, which will be the same as current marketed devices (self expandable stents), Previous Cordis validations will be leveraged for sterilization.
DV/PPQ units for both product and its packaging for the 18 new Carotid Stent Delivery System catalogs - 65cm length will be subjected to three EtO sterilization cycles,
Complaint .11andlinz/FAL 
See License Agreement for Complaint Handling and FAL.
SECTION 2 — DESIGN & DEVELOPMENT SCHEDULE

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SECTION 3 - PROJECT DELIVERABLES 
The documentation set forth in 1 and 2 immediately below are the only deliverables of Cordis to SRM for the 18 new Carotid Stent Delivery System catalogs - 65cm length project:
		
	1.
	Carotid stent delivery system (femoral access approach) documentation that will be leveraged by Cordis:

		
	a,
	Sterility Assurance Assessment

		
	b.
	Product Description

		
	c.
	Operations Strategy and Manufacturing Readiness (manufacturing process documentation)

		
	d.
	Biocompatibility (Nan and Summary Report)

		
	e.
	Supplier Qualification (Including: Specification, Strategy, Checklist, and Agreement. New SQS will be done ONLY for affected components)

		
	f.
	Environmental Impact Assessment

		
	g,
	Shelf Life Test (Protocols/Reports) to support 24 month shelf life

		
	h.
	Software Validation (Protocols/Reports)

		
	i.
	Physical Test Methods (Validation Protocols/Reports)

		
	j.
	Essential Requirement Checklist

		
	k.
	DFMEA, PFMEA, MQP, AFMEA (for application elements not impacted by the length change or SRM intended use.)

		
	2
	Documents that will be created by Cordis for SRM:

		
	a.
	Design Review I and Design Review II

		
	b.
	Design Summary (Related to length change)

		
	c.
	Product Configuration (Drawings, Specifications, etc., to reflect length change)

		
	d.
	Process Validation Strategy (Validation Change Management Assessment)

		
	e.
	Supplier Qualification (Process Strategy, Checklist for affected components)

		
	f.
	Installation Qualification/Operational Qualification (Protocols/Reports as required)

		
	g.
	Combined Design Verification /Product Performance Qualification (Protocols/Reports)

		
	h.
	Product Configuration (Bill of Materials, Route Sheets for 18 new Carotid Stent Delivery System catalogs - 65cm length)

		
	i.
	Sterility Assessment

		
	3
	For the avoidance of doubt, documents that are the sole responsibility of SRM and are not part of this Design and Development Plan:

		
	a.
	Market Opportunity Assessment

		
	b.
	Technology and Capabilities Assessment

		
	c.
	Design Change Record

		
	d.
	Prototype Evaluation (Protocol/Report — Animal)

		
	e.
	Prototype Evaluation (Protocol/Report — Bench)

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	f.
	Prototype Evaluation Summary Report

		
	g.
	Global Market Plan

		
	h.
	Pre-Clinical Study (Protocol/Report)

		
	i.
	Clinical (Study Plan, Release Engineering Test Protocol/Report, Literature Review, Product Release Authorization Clinical Product)

		
	j.
	Regional Launch Plan

		
	k.
	Declaration of Conformity

		
	1.
	Market Launch Preparation

		
	m.
	Legal Clearance

		
	n.
	Clinical Risk Management Plan

		
	o.
	Trackability TDI

		
	p.
	Deployment TDI

		
	4.
	For the avoidance of doubt, all documents relative to the intended use, are the sole responsibility of SRM, and are not part of this Design and Development Plan. These documents include but are not limited to the following:

		
	a.
	Hazard List and AFMEA

		
	b.
	Design Validation (Protocol/Report)

		
	c.
	Instructions for Use

		
	d.
	Stent Implant Card

SECTION 4 — Glossary

	
		
	Term
	Definition

	Confirmation run
	A single run of a process under normal production conditions.

	IQ/OQ
	Installation Qualification/Output Qualification, which is used synonymously with SWIP, Software Installation Protocol.

	Product Performance Qualification (PPQ)
	Documented verification that the equipment and ancillary systems, under normal production conditions, can consistently produce finished product that meets all effective specifications. This term is also referred to in industry as PV (Product Validation).

	Protocol
	A pre-approved, written plan stating how validation testing will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable results,

	Validation
	Confirmation by examination and provision of objective evidence that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.

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	Term
	Definition

	Validation Strategy (VS)
	A project-specific document that establishes the validation approach, requirements and schedule of validation activities,

	Design and Development Plan
	A plan that describes the design and development activities and defines responsibility for implementation. It also identifies and describes the interfaces with different groups or activities that provide, or result in, input to the design and development process.

	Design Review — FDA § 820.3(h)
	Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

	Design Validation — FDA § 820,3(z)
	Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

	Design Verification
	Confirmation by examination and provision of objective evidence that the design output has fulfilled requirements set out in the Technical Design Input.

	Technical Design Inputs (TDI)
	The functional, performance, and interface requirements of a product, translated from the User Requirement to an engineering level of detail that can be verified. The requirements that form the Design Input establish a basis for performing subsequent design tasks and validating the design,

	Specification — FDA § 820.3(y)
	Specification means any requirement with which a product, process, service, or other activity must conform.

	Real Time Aging
	Design verification after the product has been exposed to defined conditions for a period of time equal to or greater than the labeled shelf life. Real time aging is a confirmation of an accelerated aging study and is required if accelerated aging is required.

	Accelerated aging
	Design verification after the product has been exposed to a defined temperature and time in order to simulate a defined shelf life.

	Design Change
	A Change to fain, fit, function, identity, quality, strength, or purity of product or process Design,

	Design Change Control
	Procedures for the identification, documentation, verification or where appropriate validation, review, and approval of design changes before their implementation.

	Design Change Record
	A report summarizing the history of Design Changes and their assessment.

	Design History File - ISO/TR 14969:2004(E)
	A compilation of records, which describes and records the history of design activity.

	Design History File — FDA § 820.3(e)
	Design history file (DHF) means a compilation of records, which describes the design history of a finished device.

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	Term
	Definition

	Final Assembly
	Final assembly is defined as an assembly level at which the product or the device (or accessory to the device) is completed and suitable for use or capable of functioning, whether or not is packaged, labeled, or sterilized,

	Component
	Any raw material, subassembly, or part, which is intended to be included as part of the finished device.

	Intended Use
	Describes how the device will be used and who the end users will be. This shall include the indicated full range of use for the product.

	Leverage
	When a project team utilizes information (components, specifications, deliverables, etc.) from a preexisting project or qualified product.

	Product
	Refers to medical devices, as well as, medical drug/device combinations, Includes components, packaging, manufacturing materials, in-process product, finished product, and returned product.

	Product Configuration (PC)
	Product Configuration objects describe the physical characteristics of a product. PC object types in cPDM include Specifications, Parts, Routers, Item Master Information, Branch Item Master etc,

	Product Description (PD)
	Matrix of Design Inputs and Outputs including references to additional items such as design verification and validation activities, and risk class.

	Unqualified (UQ)
	The state, referring to a PC document, that indicates qualification requirements are incomplete, per CFM 13001 and CFM 10369616.

	Qualified (Q)
	The state, referring to a PC document that indicates successful completion of all qualification requirements, per CFM 13001 and CFM 10369616,

	Supplier
	An establishment with whom Cordis has a relationship for the procurement of goods or services to the organization.

	Failure Mode and Effects Analysis (FMEA)
	A procedure by which each potential Failure Mode or fault of a system is analyzed to determine the consequences of effects thereof on the system, to classify each potential Failure Mode according to its severity, and to recommend actions to eliminate, or compensate for, unacceptable effects.

	Sterility Assurance Level (SAL)
	Probability of a viable microorganism being present on a product after sterilization. SAL is normally expressed as 10-n. Cordis products are sterilized with an SAL of 10-6.

	Sterilization
	Validated process used to render a product free from viable microorganisms.

	Bioburden
	Populations of viable organisms on a product and/or package.

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Exhibit 3: Product Samples for SRM In-house Testing

	
			
	Project Phase
	Product Description
	Qty

	Confirmation Run
	Pre design verification units
	[*******]

	Design Verification
	Final Product configuration with full traceability packaged and sterile
	[*******]

In addition to the [*****] units for Confirmation Run and the [*****] units for Design Verification, Cordis will  provide to SRM an additional [*****] units to be used by SRM for SRM trackability and deployment force testing and studies. Any number of units greater than the [*****] set forth in this Exhibit will  be paid for by SRM at price of [*****] per unit.

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Exhibit 4: Development Plan Payment Schedule and Milestones
 
	
				
	Payment
	Milestone
	Payment by SRM to Cordis
	Completion Date

	1
	Agreement Execution
	[**********]
	 

	2
	Design Review I
	[**********]
	Within 4 months of the Effective Date of this Agreement

	3
	Design Review II
	[**********]
	Within 7 months of the Effective Date of this Agreement

	 
	Total
	[**********]
	 

The total fees payable by SRM for Development Services is set forth in this Exhibit 4 under the row entitled “Total,” and such Total includes the costs for all components and materials for Cordis to perform the Development Services in accordance with this Agreement as set forth on Exhibits 1-3.

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Exhibit 5: Commercial Supply of Product
The Parties agree that the following terms shall govern the commercial supply of Product by Cordis to SRM:
		
	1.
	Forecasts: Orders. Six (6) months prior to an anticipated regulatory approval or clearance, SRM shall provide Cordis with an initial non-binding forecast of the quantities of Products estimated to be required during the initial twelve (12) month period after such approval or clearance. Thereafter, SRM will provide to Cordis each February 1, May 1, August 1, and November 1 an updated forecast for the following (12) twelve month period commencing two (2) months from the applicable date (“Updated Forecast”). Each Updated Forecast shall be binding for (i) the first month by part number one hundred percent (100%) as to mix and volumes, (ii) the second month by part number ninety percent (90%) as to mix and volumes (iii) the third month by part number seventy five percent (75%) as to mix and volumes. The first three months of an Updated Forecast which are binding is a “Binding Quarter.” SRM’s orders for Product shall be made pursuant to a written purchase order specifying the desired quantity and configuration of Product, and subject to Section 2 of this Exhibit, will provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by SRM and Cordis. In addition, if requested by Cordis, SRM will participate in Cordis’ Sales and Operations Planning Process (S&OP) to review SRM’s forecasts, orders, and market demand changes.

		
	2.
	Acceptance of Orders. All purchase orders shall be delivered by SRM to Cordis in writing to Cordis de Mexico, S.A. de C.V. do CEVA, 950 LomaVerde, El Paso, TX 79936, Attention: Cordis de Mexico, S.A. de C.V. Plant Manager. SRM shall place all purchase orders to Cordis a minimum of eight (8) weeks prior to the desired date of delivery. SRM shall place all purchase orders for Product in a Complete Lot. SRM shall place no more than one (1) purchase order each month. SRM agrees that Cordis may deliver quantities of Product in quantities +1- 10% of the quantities set forth in the SRM purchase orders. SRM agrees that Cordis is not required to deliver Product in excess of one-hundred and fifty percent (150%) of the Updated Forecast for any month which is binding, provided that in total Cordis is not obligated to provide in excess of one hundred and twenty five percent (125%) of the Updated Forecast for any Binding Quarter. In the event Cordis is unable to accept a purchase order, Cordis will promptly notify SRM as to why it cannot accept such purchase order. In the event of any inconsistency between this Agreement and a purchase order, the terms of this Agreement shall control. For clarity, any additional or inconsistent terms in any purchase order, acknowledgement or other form are hereby excluded. “Complete Lot” shall mean a minimum quantity of [******] units of one Product code,

		
	3.
	Cancellation: Rescheduling of Delivery, SRM or its designees may cancel an outstanding purchase order by notifying Cordis in writing; provided that SRM is responsible for payment of the inventory as set forth in Section 11.6 of this Agreement. SRM may at any time reschedule the shipment date for any Products that have not been 

-35-

shipped to SRM, provided that SRM pays a reasonable restocking fee to be mutually agreed upon in writing associated with the storage of such Products.
		
	4.
	Delivery. Cordis shall ship the Products to the destination set forth in the purchase order. All shipments shall be delivered FCA (lncotenns 2010) from Cordis’ Facility to the location specified by SRM in the purchase order. The carrier shall be selected by mutual agreement between Cordis and SRM, Concurrent with the shipment of each order of Product, Cordis shall deliver to SRM a Router corresponding to such shipment in along with a Certificate of Conformity stating that the shipment complies with the Specification.

“Router” shall be limited to the following information: process flows, component traceability, inspection results (pass/fail), statistical process control results (monitoring of the critical parameters and/or defects) (pass/fail), quality assurance audit results (inspections made on the Product during manufacturing) (pass/fail), label inspection results (pass/fail), pyrogen test results (pass/fail), route sheet review (pass/fail), sterilization flow, copy of the first and last label used in the lot, label reconciliation results, set-up parameters and testing results (equipment set-up, process parameters information and results of the testing performed to the Product during manufacturing).
		
	5.
	Packaging. Products will be packaged, labeled, sterilized, and released by Cordis to SRM in accordance with (i) the Specifications and (ii) Section 6.8 and Section 8.2 of the License Agreement. Products shall be shipped to SRM in containers as agreed to by Cordis and SRM prior to the first shipment of Product. Each such container shall be individually labeled with a description of its contents, including the manufacturer name, manufacturer lot number, quantity of Products, use by date, and date of manufacture,

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Exhibit 6: Price for Supply of Product
[*******] per unit of Product

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AMENDMENT
Silk Road Medical, Inc. (“SRM”) and Cordis Corporation (“Cordis” and together with SRM, the “Parties”) are Parties to a Supply Agreement (“Supply Agreement”) dated October 21, 2011 (“Supply Agreement Effective Date”), for Cordis to perform development, manufacturing and supply services to SRM for a stent delivery system per the terms set forth therein.
For good and valuable consideration, the receipt of which is duly acknowledged, the Parties hereby agree that the design review completion dates set forth in Exhibit 4 of the Supply Agreement shall now be amended as follows:
		
	(i)
	The Design Review I completion date is no later than five (5) months from the Supply Agreement Effective Date; and

		
	(ii)
	The Design Review a completion date is no later than eight (8) months of the Supply Agreement Effective Date.

All other terms of the Supply Agreement shall remain in full force and effect without amendment.
IN WITNESS WHEREOF, the Parties have executed this Amendment by their duly authorized representatives, to be effective .as of the latest date set forth below.
	
					
	CORDIS CORPORATION
	 
	SILK ROAD MEDICAL, INC.

	 
	 
	 
	 
	 

	By:
	/s/ Jose A. Gonzalez
	 
	By:
	/s/ William Worthen

	Print:
	Jose A. Gonzalez
	 
	Print:
	William Worthen

	Title:
	WW V.P. OPS
	 
	Title:
	President & Chief Executive Officer

	Date:
	3/7/2012
	 
	Date:
	3/12/2012

SECOND AMENDMENT TO 
SUPPLY AGREEMENT
THIS SECOND AMENDMENT TO SUPPLY AGREEMENT (this “Second Amendment”) is made and entered into as of the last date of signature below (the “Second Amendment Effective Date”), by and between Silk Road Medical, Inc. (“SRM”) and Cordis Corporation (“Cordis”), with reference to the following:
A.    SRM and Cordis are parties to that certain Supply Agreement dated as of October 21, 2011, as amended as of March 12, 2012 (collectively, the “Agreement”), providing for Cordis to perform development, manufacturing and supply services for SRM for a stent delivery system per the terms set forth therein.  Capitalized terms used and not otherwise defined in this Second Amendment have the same respective meanings given to such terms in the Agreement, as amended hereby.
B.    SRM and Cordis desire to amend the Agreement in order to reflect modifications to the project scope, design and development plan, deliverables and milestone timelines contained therein, with such modifications effective as of the Second Amendment Effective Date.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1.    Amendment.
		
	(a)
	That the second sentence of Exhibit 1 (Design Inputs) to the Agreement is deleted and replaced in its entirety as follows:

The design shall refer exclusively to a stent delivery system with a working length of 57 centimeters.
		
	(b)
	That Exhibit 2 (Design and Development Plan) to the Agreement is replaced in its entirety with the amended Exhibit 2 attached hereto as Appendix A.

		
	(c)
	That the Completion Dates set forth in Exhibit 4 (Development Plan Payment Schedule and Milestones) to the Agreement are deleted and replaced in their entirety with:

Design Review I = Completion Date was extended to, and completed on, April 20, 2012
Design Review II = Completion Date shall be on or before December 18, 2012, except that if Cordis does not receive the documentation set forth in Section 1(c)(i) - (vi) of this Second Amendment on or before July 10, 2012, then the Design Review II Completion Date of December 18, 2012 shall be extended one (1) day for each day that SRM is delayed in delivering the 

documentation set forth in (i) - (vi) to Cordis, and such new date shall be defined as the Design Review H Completion Date.
		
	i.
	Final OUS (for use outside the United States) outer label (OL) content with translation & translation service certificate, certifying that each language translation is accurate,

		
	ii.
	Final OUS OL, released by SRM (verification of OL content),

		
	iii.
	Final OUS instructions for use (IFU) content with translation and translation certificate, certifying that each language translation is accurate,

		
	iv.
	Final OUS IFU, released by SRM (verification of IFU content),

		
	v.
	Final US (for use in the United States) inner label, OL, stent implant card for United States Product codes including both content and artwork, and

		
	vi.
	IFU revision 1 for United States Product codes, including both content and artwork.

		
	(d)
	That the third and fourth sentences of Section 2.4.1 of the Agreement shall be deleted and replaced in their entirety as follows:

In the event that the Design Review II is completed by Cordis pursuant to the Completion Date set forth in Exhibit 4 of the Agreement, SRM shall pay Cordis a one-time, non-creditable bonus of [************] for early completion of the Milestones (“Early Bonus”).
		
	(e)
	Section 2.4.2 shall be added to the Agreement as follows:

Additional Development Fees.  SRM has requested and Cordis agrees to perform, upon receipt of the payment set forth in this Section 2.4.2, Development Services to change the length of the Product from 65 cm to 57 cm and to increase the number of catalogs from 18 to 36, both as more specifically set forth in Exhibit 2 to the Agreement, as amended hereunder.  SRM shall pay Cordis for the Development Services set forth in the immediate foregoing sentence, in the amount of [***********], by check payment to Cordis.  Notwithstanding the payment terms in Section 2.4.1, SRM shall pay Cordis for the Development Services described in this Section 2.4.2 on the Second Amendment Effective Date.
2.    Effect.  Except as and to the extent amended by this Second Amendment, the Agreement shall remain in full force and effect in accordance with its terms.  In the event of any 

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conflict between the terms of the Agreement and this Second Amendment, the terms and conditions of this Second Amendment shall control.
3.    Counterparts.  This Second Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which together will constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have executed this Second Amendment as of the Second Amendment Effective Date.
	
					
	CORDIS CORPORATION
	 
	SILK ROAD MEDICAL, INC.

	 
	 
	 
	 
	 

	By:
	/s/ Jose A. Gonzalez
	 
	By:
	/s/ William Worthen

	Print:
	Jose A. Gonzalez
	 
	Print:
	William Worthen

	Title:
	VP Production Ops
	 
	Title:
	President & Chief Executive Officer

	Date:
	7/12/2012
	 
	Date:
	7/9/2012

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Appendix A
Exhibit 2: Design and Development Plan
SECTION 1 - PROJECT SCOPE AND APPROACHES
PRODUCT DESCRIPTION
New design consists in a shortened working length of the Precise Carotid Stent System.  Application and clinical indication is determined by SRM.
PROJECT SCOPE
Under the scope of this project:
Cordis will create and release 36 new Carotid Stent Delivery System catalogs - 57 cm length (18 final subassemblies for SRM OUS commercial distribution and 18 final subassemblies for SRM United States clinical studies).  These include combinations of six (6) stent diameters (5, 6, 7, 8, 9 and 10 mm) and three stent lengths (20 mm, 30 mm and 40 mm).

	
		
	Stent Length(mm)
	Stent Diameter(mm)

	20
	5

	20
	6

	20
	7

	20
	8

	20
	9

	20
	10

	30
	5

	30
	6

	30
	7

	30
	8

	30
	9

	30
	10

	40
	5

	40
	6

	40
	7

	40
	8

	40
	9

	40
	10

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Product packaging will be qualified by Cordis in conjunction with development of the product.
Upon written request by SRM, Cordis will, all pursuant content provided solely by SRM, revise the previously released instructions for use, labels and stent implant card for the 18 final subassemblies for U.S. clinical studies to make them applicable for U.S. commercial distribution, and will provide such deliverables to SRM no later than five (5) months following receipt of SRM’s request.  For the avoidance of doubt, this one revision is part of the project scope and SRM is not required to pay any additional fees for this revision.
If testing is needed to support the revision of the instructions for use, labels, and stent implant cards, testing expenses (units and laboratory) shall be paid by SRM at the rate of [****] USD per unit.

MANUFACTURING SITE
New Carotid Stent Delivery System catalogs with 57 cm length assembly and packaging will be performed at Cordis de Mexico.  Sterilization will be performed at Steris Isomedix Inc. sterilization facilities in El Paso, Texas.

FUNCTIONAL REPRESENTATIVES: Team members, roles, and responsibilities are subject to change at Cordis’ sole discretion.

	
			
	Team Member
	Roles
	Responsibilities

	OETS (Sustaining) / Operations

	James Merrit
	MEST Director
	Overall Project Leadership.

	Victor Baylon
	MEST (Value Engineering) Manager
	Project Manager. Provide input for this D&D plan.

	Laura Gisela Rico
	Lead MEST (Value Engineering) Engineer 
(Project Leader)
	Project leader. Plan and execute key activities as per this D&D plan.

	Laura C. Irigoyen
	MIST (Value Engineering) Engineer
	Provide project support.

	Daniel Gonzalez
	MEST (Value Engineering) Engineer
	Provide project support.

	Iris Castillo
	MEST (Value Engineering /Contractor) – Packaging Engineer.
	Provide project support in the area of packaging. Plan and execute key packaging related activities as per this D&D plan.

	Antolin Salazar
	MEST (Value Engineering) Technician
	Provide project support.

	Victor Baylon
	Packaging Manager
	Overall Packaging Leadership

-5-

	
			
	Team Member
	Roles
	Responsibilities

	Yipsi Bowley
	MEST (Labeling and Packaging) Manager
	Provide Design Control support. Provide input for this D&D plan.

	R&D

	Wilson Tsang
	R&D Eng/Mgr
	Provide support for planning & execution of Design Verification/Validation as per this D&D plan.

	Quality Assurance

	Nancy Amaya
	QA Director
	Overall QA leadership

	Hector Medrano
	QA Manager
	QA project management. Provide input into this D&D plan.

	Adriana Gamez
	PQS/FAL Manager
	Provide support/direction for this D&D Plan

	Tatiana Del Valle
	QA Engineer
	QA Support

	Operations

	Jose Salcedo
	Mfg Manager
	Operations Management.

	Juan Carlos Gallegos
	Mfg Eng Ops
	Provide project support.

	Cross-Functional Support

	Dennis Griffin
	Regulatory Affairs Manager
	Overall Regulatory Affairs project management, provide input for Regulatory Approach

	Independent Peers

	Nitin Salunke
	R&D Mgr
	Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan

	Sergio Muñoz
	QA Engineer
	Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan

	Carlos Henao
	OPS Engineer
	Serve as Independent Peer for Technical Design Review(s) as per this D&D Plan

Design & Development APPROACHES
Marketing
Marketing Objectives
Responsibility of SRM.
Volume Expectations
Refer to Sections 3.3 and 3.3.1 of the Agreement for Minimum Volume commitments.  Refer to Exhibit 5 of the Agreement for Forecast timelines and process.

-6-

Pricing Strategy
Pricing for final customer is managed by SRM.
Branding Name Strategy
Branding name strategy for 36 new Carotid Stent Delivery System catalogs — 57 cm length will be selected by SRM.
Initial Sales Forecast and ISS Requirements
[*********] units will be manufactured as the Initial Shelf Stock (ISS) requirement for product launch.  Manufacture and delivery of ISS is not included in Development Fees.  SRM shall place a written purchase order for the ISS, the price of which is [*****] per unit.
Desired Clinical Indications
To be determined by SRM (not part of this plan)
Desired Performance Claims
To be determined by SRM (not part of this plan)
Key Marketing Activities
To be determined by SRM (not part of this plan)
Regulatory
Distribution Region
To be determined by SRM (not part of this plan)
Regulatory Classification
To be determined by SRM (not part of this plan)
Submission Type
To be determined by SRM (not part of this plan)
Regulatory Pathway
To be determined by SRM (not part of this plan)

-7-

Promotional Claims
To be determined by SRM (not part of this plan)
Import/Export Requirements:
To be determined by SRM (not part of this plan)
Testing Requirements
As determined by Cordis, Cordis will leverage the TDI’s corresponding to the PMA approved PRECISE products marketed by Cordis, except those that are specific to the new length (57cm), which will be performed for the new length as set forth in the section Product Design Verification of this Design and Development Plan.  Testing related to simulated use must be responsibility of SRM; since the clinical application of this product will be developed and validated by SRM.

Operations Planning
Carotid Stent Delivery System catalogs with 57cm length validation, such activities specified in this Design and Development Plan will be managed per Cordis Quality System.
Design Reviews
The following Technical Design Reviews (TDR) will be completed by Cordis for the carotid stent delivery system catalogs with 57cm length project:
		
	•
	Design Review I: Combined Design Input, Concept Selection and Planning & Design Output Technical Design Review (Prototypes testing completed)

		
	•
	Design Review II: Combined Verification/Validation and Design and Technology Transfer Technical Design Review (DV/PQ Report approved)

Evidence of completion of these design reviews will be documented as required per Cordis Quality System.
A Clinical Readiness Design Review is responsibility of SRM and will not be documented in the Cordis Quality System.
Design History File
A new electronic DHF will be created by Cordis for the 36 new Carotid Stent Delivery System catalogs - 57cm length project to allow for development and release of new documentation for these codes.
Risk Assessment and Mitigation

-8-

SRM is responsible for the risk management plan documentation required for 36 new Carotid Stent Delivery System catalogs - 57cm length due to new application (transcervical approach).
Concept Evaluation and Selection - Product & Package
Concept Generation
Cordis will manufacture the Product and SRM will brand the Product.
Prototyping Activities
Prototypes will be run by Cordis as a pre-requisite of the Design Verification/Product Performance Qualification.  A summary of these evaluations, including reliability analysis of the testing done will be captured in an engineering report written by Cordis and provided to SRM.
Design Assessments
There is neither animal testing nor customer use feedback from Cordis for the 36 new Carotid Stent Delivery System catalogs - 57cm length.  Clinical trial is responsibility of SRM.
Test Method Development
Existing Cordis Test Methods will be used by Cordis to assess the change in the length of the 36 new Carotid Stent Delivery System catalogs - 57cm.  If any test method is not applicable based on the SRM intended use, technical design input must be performed by SRM.

Design Characterization
Design Characterization Activities
A tolerance stack up analysis will be done by Cordis to determine lengths for the 36 new Carotid Stent Delivery System catalogs - 57cm length components, Outer Member, Support Member, and their components.  This stack up analysis will be used to determine dimensions for the components and for the packaging.
Key design elements not being modified or impacted as a result of the 57cm pivduct include the stent, SDS, packaging (except product tray), as existing components will be utilized and there is no change or impact at the manufacturing/process level.  Changes will be done only to remove the Cordis and J&J branding.
Anticipated Design Iterations and Contingencies
There are no planned design iterations and contingencies.

-9-

Product Design Verification,
Technical Design Inputs (TDIs) affected by the change on the length (57cm) will be tested by Cordis for the 36 new SRM Carotid Stent Delivery System catalogs - 57cm length project and will be based on length modification and size bracketing strategy.  The only This that Cordis will test are as follows:
		
	•
	Usable length

		
	•
	Exit port location

		
	•
	MB Positioning

		
	•
	Stent pre-deployment

		
	•
	OM stoke length

		
	•
	Hub/hypotube pull strength

		
	•
	Hub/proximal wire pull strength

		
	•
	Wire lumen/Proximal wire/PET Sleeve pull strength

		
	•
	SM distal hypotube/proximal wire pull strength

		
	•
	Coil Stop pull strength

For the avoidance of doubt, SRM will test TDIs for trackability and deployment force.  Cordis will provide to SRM the following information (i) test method parameters and acceptance criteria Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force and which Cordis determines are applicable to the Product, and (ii) sample sizes Cordis uses to test Cordis’ PRECISE® Carotid Stent System for trackability and deployment force.  Manufacture units for trackability and deployment force testing are included in the scope of the Development Fees up to the maximum number of units set forth in Exhibit 3 of the Supply Agreement.
For the avoidance of doubt, TDIs that will not be tested by Cordis for the 36 new Carotid Stent Delivery System catalogs - 57cm length project are:
		
	•
	Crossing profile

		
	•
	Luer fitting

		
	•
	Air embolized

		
	•
	Ability to aspirate

		
	•
	Wire lumen ID

-10-

		
	•
	SDS Tip ID

		
	•
	Deployment accuracy

		
	•
	OM hub/hemovalve joint torque

		
	•
	Pod/body fuse joint pull strength & elongation

		
	•
	Brite tip/pod fuse joint strength

		
	•
	Wire lumen tip pull strength

Design Verification (DV) & Product Performance Qualification (PQ) for the 36 new Carotid Stent Delivery System catalogs - 57cm length will be combined and will address qualification of the product.  DV/PQ units will be subjected to three EtO sterilization cycles.
Stability is not required as this product does not contain drug.

Packaging, Design Verification
Design Verification related to packaging are the impacted TDI’s related to the packaging configuration (tray, pouch, sheath extrusion (length change), carton) only.  The only TDIs that Cordis will be tested as part of the Design Verification for packaging are:
		
	•
	Product Migration

		
	•
	Product Visual Inspection

		
	•
	Packaging Integrity Test (Visual Inspection)

		
	•
	Package Challenge Test (Bubble Test)

		
	•
	Dye Penetration Test

		
	•
	Seal Pull Test

DV & PQ for the packaging will be combined.  DV/PQ units will be subjected to three EtO sterilization cycles.
No aging testing will be performed by Cordis for the 36 new Carotid Stent Delivery System catalogs - 57cm length project.

-11-

Quality
Cordis Quality System is used by Cordis.

Design Validation - Product/Package
Product
The Carotid Stent Delivery System catalogs with 57cm length will be manufactured for SRM.
Design Validation for SRM intended use of the product is responsibility of SRM.
Product labeling dimensions are:
		
	•
	Outer label: 5.625” x 9.625”

		
	•
	Inner label: 5.25” x 8.825”

SRM to provide label content to Cordis.  Fasson Trans-Therm 2 material to be used by Cordis.  No aging testing will be performed for the 36 new Carotid Stent Delivery System catalogs -57cm length labeling.
SRM to provide to Cordis artwork and content for both instructions for use and stent implant card for the DV/PQ.  For the avoidance of doubt, SRM is solely responsible for ensuring that the artwork and content of the instructions for use and stent implant card meet the requirements of all laws and regulations.
Cordis will purchase the materials for the instructions for use and stent implant card, which will fabricate by using the existing qualified Cordis specification (dimensions, materials, weight)
No clinical trial will be done by Cordis to support the 36 new Carotid Stent Delivery System catalogs - 57cm length.
Process Validation
Project approach to Process Validation will be done according to Cordis Quality System.
Sterilization
The Sterilization strategy is to be 3X EtO capable, which will be the same as current marketed devices (self expandable stents).  Previous Cordis validations will be leveraged for sterilization.
DV/PQ units for both product and its packaging for the 36 new Carotid Stent Delivery System catalogs - 57cm length will be subjected to three EtO sterilization cycles.
Complaint Handling/FAL
See License Agreement for Complaint Handling and FAL.
SECTION 2 - DESIGN & DEVELOPMENT SCHEDULE

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For detailed timeline see Attachment 1.

SECTION 3 - PROJECT DELIVERABLES
The documentation set forth in 1 and 2 immediately below are the only deliverables of Cordis to SRM for the 36 new Carotid Stent Delivery System catalogs - 57cm length project:
		
	1.
	Carotid stent delivery system (femoral access approach) documentation that will be leveraged by Cordis:

		
	a.
	Sterility Assurance Assessment

		
	b.
	Product Description

		
	c.
	Operations Strategy and Manufacturing Readiness (manufacturing process documentation)

		
	d.
	Biocompatibility (Plan and Summary Report)

		
	e.
	Supplier Qualification (Including: Specification, Strategy, Checklist, and Agreement.  New SQS will be done ONLY for affected components)

		
	f.
	Environmental Impact Assessment

		
	g.
	Shelf Life Test (Protocols/Reports) to support 24 months shelf life

		
	h.
	Software Validation (Protocols/Reports)

-13-

		
	i.
	Physical Test Methods (Validation Protocols/Reports)

		
	j.
	Essential Requirement Checklist (for application elements not impacted by the length change or SRM intended use)

		
	k.
	DFMEA, PFMEA, MQP, AFMEA (for application elements not impacted by the length change or SRM intended use)

		
	2.
	Documents that will be created by Cordis for SRM:

		
	a.
	Design Review I and Design Review II

		
	b.
	Design Summary (Related to length change)

		
	c.
	Product Configuration (Drawings, Specifications, etc., to reflect length change)

		
	d.
	Process Validation Strategy (Validation Change Management Assessment)

		
	e.
	Supplier Qualification (Process Strategy, Checklist for affected components)

		
	f.
	Installation Qualification/Operational Qualification (Protocols/Reports as required)

		
	g.
	Combined Design Verification /Product Performance Qualification (Protocols/Reports)

		
	h.
	Product Configuration (Bill of Materials, Route Sheets for 36 new Carotid Stent Delivery System catalogs - 57cm length)

		
	i.
	Sterility Assessment

		
	3.
	For the avoidance of doubt, documents that are the sole responsibility of SRM and are not part of this Design and Development Plan:

		
	a.
	Market Opportunity Assessment

		
	b.
	Technology and Capabilities Assessment

		
	c.
	Design Change Record

		
	d.
	Prototype Evaluation (Protocol/Report — Animal)

		
	e.
	Prototype Evaluation (Protocol/Report — Bench)

		
	f.
	Prototype Evaluation Summary Report

		
	g.
	Global Market Plan

-14-

		
	h.
	Pre-Clinical Study (Protocol/Report)

		
	i.
	Clinical (Study Plan, Release Engineering Test Protocol/Report, Literature Review, Product Release Authorization Clinical Product)

		
	j.
	Regional Launch Plan

		
	k.
	Declaration of Conformity

		
	l.
	Market Launch Preparation

		
	m.
	Legal Clearance

		
	n.
	Clinical Risk Management Plan

		
	o.
	Trackability TDI

		
	p.
	Deployment TDI

		
	4.
	For the avoidance of doubt, all documents relative to the intended use, are the sole responsibility of SRM, and are not part of this Design and Development Plan.  These documents include but are not limited to the following:

		
	a.
	Hazard List and AFMEA

		
	b.
	Design Validation (Protocol/Report)

SECTION 4 – Glossary

	
		
	Term
	Definition

	Confirmation run
	A single run of a process under normal production conditions.

	IQ
	Installation Qualification/Output Qualification, which is used synonymously with SWIP, Software Installation Protocol.

	Product Performance Qualification (PQ)
	Documented verification that the equipment and ancillary systems, under normal production conditions, can consistently produce finished product that meets all effective specifications. This term is also referred to in industry as PV (Product Validation).

	Protocol
	A pre-approved, written plan stating how validation testing will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable results.

	Validation
	Confirmation by examination and provision of objective evidence that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.

-15-

	
		
	Term
	Definition

	Validation Strategy (VS)
	A project-specific document that establishes the validation approach, requirements and schedule of validation activities.

	Design and Development Plan
	A plan that describes the design and development activities and defines responsibility for implementation. It also identifies and describes the interfaces with different groups or activities that provide, or result in, input to the design and development process.

	Design Review - FDA § 820.3(h)
	Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

	Design Validation - FDA § 820.3(z)
	Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

	Design Verification
	Confirmation by examination and provision of objective evidence that the design output has fulfilled requirements set out in the Technical Design Input.

	Technical Design Inputs (TDI)
	The functional, performance, and interface requirements of a product, translated from the User Requirement to an engineering level of detail that can be verified. The requirements that form the Design Input establish a basis for performing subsequent design tasks and validating the design.

	-Specification - FDA § 820.3(y)
	Specification means any requirement with which a product, process, service, or other activity must conform.

	Real Time Aging
	Design verification after the product has been exposed to defined conditions for a period of time equal to or greater than the labeled shelf life. Real time aging is a confirmation of an accelerated aging study and is required if accelerated aging is required.

	Accelerated aging
	Design verification after the product has been exposed to a defined temperature and time in order to simulate a defined shelf life.

	Design Change
	A Change to form, fit, function, identity, quality, strength, or purity of product or process Design.

	Design Change Control
	Procedures for the identification, documentation, verification or where appropriate validation, review, and approval of design changes before their implementation.

	Design Change Record
	A report summarizing the history of Design Changes and their impact assessment.

	Design History File - ISO/TR 14969:2004(E)
	A compilation of records, which describes and records the history of the design activity.

	Design History File - FDA § 820.3(e)
	Design history file (DHF) means a compilation of records, which describes the design history of a finished device.

	Final Assembly
	Final assembly is defined as an assembly level at which the product or the device (or accessory to the device) is completed and suitable for use or capable of functioning, whether or not is packaged, labeled, or sterilized.

	Component
	Any raw material, subassembly, or part, which is intended to be included as part of the finished device.

-16-

	
		
	Term
	Definition

	Intended Use
	Describes how the device will be used and who the end users will be. This shall include the indicated full range of use for the product.

	Leverage
	When a project team utilizes information (components, specifications, deliverables, etc.) from a preexisting project or qualified product.

	Product
	Refers to medical devices, as well as, medical drug/device combinations. Includes components, packaging, manufacturing materials, in-process product, finished product, and returned product.

	Product Configuration (PC)
	Product Configuration objects describe the physical characteristics of a product. PC object types in cPDM include Specifications, Parts, Routers, Item Master Information, Branch Item Master etc.

	Product Description (PD)
	Matrix of Design Inputs and Outputs including references to additional items such as design verification and validation activities, and risk class.

	Unqualified (UQ)
	The state, referring to a PC document, that indicates qualification requirements are incomplete, per CFM 13001 and CFM 10369616.

	Qualified (Q)
	The state, referring to a PC document that indicates successful completion of all qualification requirements, per CFM 13001 and CFM 10369616.

	Supplier
	An establishment with whom Cordis has a relationship for the procurement of goods or services to the organization.

	Failure Mode and Effects Analysis (FMEA)
	A procedure by which each potential Failure Mode or fault of a system is analyzed to determine the consequences of effects thereof on the system, to classify each potential Failure Mode according to its severity, and to recommend actions to eliminate, or compensate for, unacceptable effects.

	Sterility Assurance Level (SAL)
	Probability of a viable microorganism being present on a product after sterilization. SAL is normally expressed as 10-n. Cordis products are sterilized with an SAL of 10-6.

	Sterilization
	Validated process used to render a product free from viable microorganisms.

	Bioburden
	Populations of viable organisms on a product and/or package.

-17-

THIRD AMENDMENT TO  
SUPPLY AGREEMENT
THIS THIRD AMENDMENT TO SUPPLY AGREEMENT (this “Third Amendment”) is made and entered into as of the last date of signature below (the “Third Amendment Effective Date”), by and between Silk Road Medical, Inc. (“SRM”) and Cordis Corporation (“Cordis”), with reference to the following:
A.    SRM and Cordis are parties to that certain Supply Agreement dated as of October 21, 2011, as amended as of March 12, 2012 and as of July 12, 2012 (collectively, the “Agreement”), providing for Cordis to perform development, manufacturing and supply services for SRM for a stent delivery system per the terms set forth therein. Capitalized terms used and not otherwise defined in this Third Amendment have the same respective meanings given to such terms in the Agreement, as amended hereby.
B.    SRM and Cordis desire to amend the Agreement as set forth below, with such amendments effective as of the Third Amendment Effective Date.
1.    NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows: Amendment.
		
	(a)
	The Second sentence of Exhibit 5 (Commercial Supply of Product) of the Agreement, Section 4 (Delivery) is hereby deleted in its entirety and replaced with the following:

“All shipments shall be delivered DAT (Incoterms 2010) to the SRM selected carrier located at CEVA Logistics located at 1240 Don Haskins Drive, El Paso, Texas 79936 or such other warehouse as designated by Cordis (“Pick-Up Location).”
		
	(b)
	Section 6 is hereby added to Exhibit 5 (Commercial Supply of Product) of the Agreement as follows:

“6.Responsibility. For clarity, Cordis is fully responsible for the storage, transportation and risk of loss of the Products (unfinished or finished) during their delivery from the Facility to SRM selected carrier at the Pick-Up Location. The Parties acknowledge and agree that such delivery may include delivery to and from one or more intermediate third party sterilization, processing or storage facilities. SRM shall be responsible for the risk of loss of Product beginning upon loading on to the SRM selected carrier. SRM shall be responsible for the importation of the Products (under SRM Importer of Record) over the United States-Mexico border, including the preparation and provision of any documentation required by government authorities in either country in connection therewith; except that Cordis shall provide the Mexican Custom’s invoke. SRM and its selected broker agency shall be responsible for 

the U.S. Customs and Border Protection documentation during the importation process. SRM shall be responsible to provide the documentation of destruction or exportation of the Product, to the FDA and/or U.S. Customs and Border Protection and as otherwise required under applicable law. The foregoing obligations shall be included under “Import/Export Requirements” in Exhibit 2 to this Agreement.”
2.    Effect. Except as and to the extent amended by this Third Amendment, the Agreement shall remain in full force and effect in accordance with its terms. In the event of any conflict between the terms of the Agreement and this Third Amendment, the terms and conditions of this Third Amendment shall control.
3.    Counterparts. This Third Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which together will constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have executed this Third Amendment as of the Third Amendment Effective Date.
	
					
	CORDIS CORPORATION
	 
	SILK ROAD MEDICAL, INC.

	 
	 
	 
	 
	 

	By:
	/s/ Tom Turley
	 
	By:
	/s/ Erica Rogers

	Print:
	Tom Turley
	 
	Print:
	Erica Rogers

	Title:
	FODL
	 
	Title:
	President & Chief Executive Officer

	Date:
	4/17/2013
	 
	Date:
	4/19/2013

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FOURTH AMENDMENT TO 
SUPPLY AGREEMENT
THIS FOURTH AMENDMENT TO SUPPLY AGREEMENT (this “Fourth Amendment”) is made and entered into as of the last date of signature below (the “Fourth Amendment Effective Date”), by and between Silk Road Medical, Inc. (“SRM”) and Cordis Corporation (“Cordis”), with reference to the following:
A.    SRM and Cordis are parties to that certain Supply Agreement dated as of October 21, 2011, as amended as of March 12, 2012, July 12, 2012 and April 19, 2013 (collectively, the “Agreement”), providing for Cordis to perform development, manufacturing and supply services for SRM for a stent delivery system per the terms set forth therein.  Capitalized terms used and not otherwise defined in this Fourth Amendment have the same respective meanings given to such terms in the Agreement, as amended hereby.
B.    SRM and Cordis desire to amend the Agreement as set forth below, with such amendments effective as of the Fourth Amendment Effective Date.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
		
	1.
	Amendment. Exhibit 5 of the Agreement is hereby deleted in its entirety and replaced with the following Exhibit 5:

“Exhibit 5: Commercial Supply of Product
The Parties agree that the following terms shall govern the commercial supply of Product by Cordis to SRM:
		
	1.
	FORECASTS; Orders.  SRM will provide to Cordis on a monthly basis an updated rolling forecast of expected purchases for the following (24) twenty four month period commencing two (2) months from the applicable date (“Updated Forecast”). Each Updated Forecast shall be binding for (i) the first month by part number one hundred percent (100%) as to mix and volumes, (ii) the second month by part number ninety percent (90%) as to mix and volumes (iii) the third month by part number seventy five percent (75%) as to mix and volumes.  The first three months of an Updated Forecast which are binding is a “Binding Quarter.” SRM’s orders for Product shall be made pursuant to a written purchase order specifying the desired quantity and configuration of Product, and subject to Section 2 of this Exhibit, will provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by SRM and Cordis. In addition, if requested by Cordis, SRM will participate in Cordis’ Sales and Operations Planning Process (S&OP) to review SRM’s forecasts, orders, and market demand changes.

		
	2.
	ACCEPTANCE of ORDERS.  All purchase orders shall be delivered by SRM to Cordis through the Cardinal Health Customer Service team, using any of the standard ordering channels.  SRM shall place all purchase orders to Cordis a minimum of eight (8) weeks prior to the desired date of delivery.  SRM shall place all purchase orders for Product in a Complete Lot.  SRM shall place no more than one (1) purchase order each month.  SRM agrees that Cordis may delivery quantities of Product in quantities +/-10% of the quantities set forth in the SRM purchase orders.  SRM agrees that Cordis is not required to deliver Product in excess of one-hundred and fifty percent (150%) of the Updated Forecast for any month which is binding, providing that in total Cordis is not obligated to provide in excess of one hundred and twenty five percent (125%) of the Updated Forecast for any Binding Quarter.  In the event Cordis is unable to accept a purchase order, Cordis will promptly notify SRM as to why it cannot accept such purchase order.  In the event of any inconsistency between this Agreement and a purchase order, the terms of this Agreement shall control.  For clarity, any additional or inconsistent terms in any purchase order, acknowledgment or other form are hereby excluded.  “Complete Lot” shall mean a minimum quantity of [*****] of one Product code.

		
	3.
	CANCELLATION; RESCHEDULING of DELIVERY.  SRM or its designees may cancel an outstanding purchase order by notifying Cordis in writing; provided that SRM is responsible for payment of the inventory as set forth in Section 11.6 of this Agreement.  SRM may at any time reschedule the shipment date for any Products that have not been shipped to SRM, provided that SRM pays a reasonable restocking fee to be mutually agreed upon in writing associated with the storage of such Products.

		
	4.
	DELIVERY.  All shipments shall be delivered to the carrier at Cordis’ distribution facility located in Texas or Mississippi (the “Distribution Center”) for delivery to the location specified by SRM in the purchase order.  The carrier shall be selected by mutual agreement of SRM and Cordis, except that if no such agreement is reached in good faith, the carrier shall be the standard carrier used by the Cardinal Health Customer Service team for freight that is to be transported via truck.  Each shipment of Products shall be insured for the benefit of SRM.  Concurrent with the shipment of each order of Product, Cordis shall deliver to SRM a Router corresponding to such shipment in along with a Certificate of Conformity stating that the shipment complies with the Specification.  Title and risk of loss shall transfer to SRM at the time Cordis delivers the Products to the carrier at the Distribution Center.  SRM shall be invoiced for transportation costs from the Distribution Center to the location specified by SRM in the purchase order.

“Router” shall be limited to the following information; process flows, component traceability, inspection results (pass/ fail), quality assurance audit results (inspections made on the Product during manufacturing) (pass fail), label inspection results (pass/ fail), pyrogen testing results (pass/ fail), route sheet review (pass/ fail), sterilization 

-2-

flow, copy of the first and last label used in the lot, label reconciliation results, set-up parameters and testing results (equipment set-up, process parameters information and results of the testing performed to the Product during manufacturing).
		
	5.
	PACKAGING.  Products will be packaged, labeled, sterilized, and released by Cordis to SRM in accordance with (i) the Specifications and (ii) Section 6.8 and Section 8.2 of the License Agreement.  Products shalt be shipped to SRM in containers as agreed to by Cordis and SRM prior to the first shipment of Product.  Each such container shall be individually labeled with a description of its contents, including the manufacturer name, manufacturer lot number, quantity of Products, use by date, and date of manufacture.

		
	6.
	RESPONSIBILITY.  For clarity, Cordis is fully responsible for the storage, transportation and risk of loss of the Products (unfinished or finished) during their transit from the Facility to the carrier at the Distribution Center.  The Parties acknowledge and agree that such delivery may include delivery to and from one or more intermediate third party sterilization, processing or storage facilities.

		
	2.
	Effect.  Except as and to the extent amended by this Fourth Amendment, the Agreement shall remain in full force and effect in accordance with its terms.  In the event of any conflict between the terms of the Agreement and this Fourth Amendment, the terms and conditions of this Fourth Amendment shall control.

		
	3.
	Counterparts.  This Fourth Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which together will constitute one and the same instrument.

IN WITNESS WHEREOF, the parties hereto have executed this Fourth Amendment as of the Fourth Amendment Effective Date.
	
					
	CORDIS CORPORATION
	 
	SILK ROAD MEDICAL, INC.

	 
	 
	 
	 
	 

	By:
	/s/ Stephen Davis
	 
	By:
	/s/ Lucas Buchanan

	Print:
	Stephen Davis
	 
	Print:
	Lucas Buchanan

	Title:
	Director Business Development
	 
	Title:
	CFO

	Date:
	April 9, 2018
	 
	Date:
	4/4/2018

-3-Exhibit

Exhibit 10.7

LICENSE AGREEMENT
This License Agreement (“Agreement”) is entered into as of the Effective Date by and between Cordis Corporation, a corporation duly organized and existing under the laws of the state of Florida and having its principal office at 430 Route 22 East, Bridgewater, NJ 088070908 (“Cordis” and a “Party”), and Silk Road Medical, Inc., a corporation duly organized and existing under the laws of the state of Delaware and having its principal office at 735 North Pastoria Avenue, Sunnyvale, California 94085 (“SRM”, a “Party”, and collectively with Cordis, the “Parties”).
WHEREAS, Cordis owns certain patent rights and technical and regulatory information concerning its PRECISE® Carotid Stent System;
WHEREAS, SRM has a business in transcervical access to, flow-altered treatment of, and closure of the access point into, the carotid artery;
WHEREAS, SRM intends to develop a modified stent delivery system optimized for transcervical implantation of the PRECISE® carotid stent, for which SRM intends to submit a PMA application as well as other international regulatory approvals and to CE mark the device in accordance with EU law;
WHEREAS, SRM wishes to license from Cordis certain intellectual property related to the PRECISE® carotid stent, including the right to reference clinical data and other information contained in the Cordis PMA, the Cordis Design Dossier, and/or other regulatory submissions applicable to the Cordis PRECISE® Carotid Stent System and
WHEREAS, the Parties wish to work together pursuant to the terms of this Agreement, to enable SRM to achieve its goals;
NOW THEREFORE, in consideration of the premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1.DEFINITIONS
For the purposes of this Agreement, the following terms shall have the following meanings:
		
	1.1.
	“Affiliate” means any corporation, company, partnership, joint venture and/or firm which controls, is controlled by, or is under common control with a Party hereto. For purposes of this definition, “control” shall mean (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares entitled to vote for the election of directors; or (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

[***]     Information has been omitted and submitted separately to the Securities and Exchange Commission. Confidential 
treatment has been requested with respect to the omitted portions.

		
	1.2.
	“Control” or “Controlled” shall mean with respect to any (i) item of information, including, without limitation, know-how, or (ii) intellectual property right; the possession (whether by ownership or license) by a Party of the ability to grant to the other Party access and/or a license as provided herein under such item or right without violating the terms of any agreement or other agreements with any third party.

		
	1.3.
	“Cordis Patent Rights” means the U.S. patent and patent applications set forth in Appendix A that constitute the PRECISE® Carotid Stent System Portfolio, including any divisionals, continuations, continuation-in-part applications, of the foregoing, U.S. patents issuing from the foregoing applications, U.S. patents resulting from reissues or reexaminations thereof and extensions thereof, and foreign patents and patent applications claiming priority to any of the foregoing.

		
	1.4.
	“Cordis Technology” shall mean all inventions and ideas, whether or not patentable, know-how, processes, information and data, including any copyright or trade secret relating thereto, which (i) are owned or Controlled by CORDIS or its Affiliates as of the Effective Date or (ii) which are developed, acquired or otherwise come into ownership or Control of CORDIS during the Term of this Agreement from a third party other than SRM, and includes the PRECISE® Carotid Stent System and Cordis Patent Rights.

		
	1.5.
	“Effective Date” means December 17, 2010.

		
	1.6.
	“Exit Transaction” means in one transaction or in a series of related transactions, (i) the sale, transfer or other similar disposition of SRM Assets, or (ii) a merger, acquisition, consolidation or similar event involving the entirety of the SRM entity, with or to another non-Affiliate entity in which SRM’s stockholders, immediately prior to such event, do not hold at least fifty percent (50%) of the voting securities of the other non-Affiliate entity (or the ultimate parent of such entity) immediately following such event involving the entirety of the SRM entity. The entity which participates in an Exit Transaction with SRM shall be referred to as SRM’s “assignee/successor.”

		
	1.7.
	“Gross Sales” means any and all forms of consideration, monetary or otherwise, received by SRM or any of its Affiliates from the sale, lease, license or other disposition of Licensed Products and Licensed Methods.  For the avoidance of doubt, internal licenses, transfers and sales between SRM and any of its Affiliates shall not be calculated as part of the Gross Sales.

		
	1.8.
	“Licensed Product” means any SRM product that if made, used, offered for sale, sold or imported would, but for the licenses granted herein, infringe one or more of the Cordis Patent Rights in the SRM Field.

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	1.9.
	“Licensed Method” means any SRM process or procedure that, but for the license granted herein, would infringe one or more of the Cordis Patent Rights in the SRM Field.

		
	1.10.
	“Licensed IP” means the Licensed Products and Licensed Methods.

		
	1.11.
	“Net Sales” means Gross Sales minus: (1) customary trade, quantity or cash discounts and non-affiliated brokers’ or agents’ commissions actually allowed and taken; (2) import, export, excise, sales and value added taxes, custom duties and freight, shipping and insurance costs, to the extent separately stated on the purchase order, invoice or other document of sale; and (3) credits for returns.

		
	1.12.
	“SRM Assets” means (i) substantially all of SRM’s equity, or (ii) all or substantially all of SRM’s assets to which this Agreement relates.  For the purpose of clarity, the assets referred to in clause (ii) do not include that portion of SRM Technology concerning the diagnosis and/or treatment of stroke or neurovascular conditions other than carotid artery disease.

		
	1.13.
	“SRM Field” means methods, materials, protocols, assays, devices, machines and apparatus related to transcervical treatment of carotid artery disease with an intravascular stent where blood vessels are accessed from the neck and cervical area utilizing a stent delivery system having a maximum working length of 90 centimeters. For the avoidance of doubt, the SRM Field does not include transfemoral access to the vasculature.

		
	1.14.
	“SRM Technology” means all inventions and ideas, whether or not patentable, know-how, processes, information and data, including any copyright or trade secret relating thereto, for the transcervical access to, blood-flow alteration within, intervention within (including through delivery of stents mounted on particular, transcervical-specific stent delivery systems), and closure of the access point into, the carotid artery, for purposes of diagnosis and/or treatment of carotid artery disease, stroke, and other neurovascular conditions, which (i) are owned or Controlled by SRM as of the Effective Date, or (ii) which are developed, acquired or otherwise come into ownership or Control of SRM during the Term of this Agreement from a third party other than Cordis.

		
	1.15.
	For purposes of this Agreement, the CE mark for the Cordis PRECISE® Carotid Stent System shall mean the mark demonstrating conformity of the PRECISE® Carotid Stent System with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and subsequent amendments.

		
	1.16.
	“Cordis PMA” shall mean Premarket Approval Application P030047, which received PMA Approval on September 22, 2006, together with all approved PMA Supplements thereto.

-3-

		
	1.17.
	[RESERVED].

		
	1.18.
	“FDA” shall mean the United States Food and Drug Administration.

		
	1.19.
	“FDCA” shall mean the United States Federal Food, Drug, and Cosmetic Act of 1938, as amended (21 U.S.C. §§ 301 et. seq.).

		
	1.20.
	“Law” shall mean any United States or non-United States federal, national, European Union, supranational, state, provincial, local or similar law, ordinance, regulation, rule, code, directive, order, or requirement.

		
	1.21.
	“Notified Body” shall mean any third party designated by the Competent Authorities in EU Member States, to participate in assessment of the conformity of certain classes of medical devices with applicable EU rules and, upon completion of such assessment, required to issue related CE certificate(s) of conformity of such medical devices with applicable EU law.

		
	1.22.
	“PMA Application” and/or “Premarket Approval Application” shall mean a premarket approval application under section 515(c) of the FDCA requesting the FDA’s approval to commercially sell and distribute a medical device in the United States and its territories and possessions, including all information submitted with or incorporated by reference therein.

		
	1.23.
	“PMA Approval” shall mean approval from the FDA of a PMA Application.

		
	1.24.
	“PMA Supplement” shall mean a supplemental application to an approved PMA Application, including all information submitted with or incorporated by reference therein.

		
	1.25.
	“PMA Supplement Approval” shall mean approval from the FDA of a PMA Supplement.

		
	1.26.
	“Regulatory Authority” shall mean with respect to any country or jurisdiction, any governmental entity involved in granting approval of, accepting notification of, or regulating the investigation, manufacture, distribution, marketing, sale, pricing or reimbursement of a Licensed Product, a Licensed Method or the Cordis PRECISE® Carotid Stent System in that country or jurisdiction.

		
	1.27.
	“Right of Access Letter” shall mean a letter from Cordis to BSI, or other Notified Body as applicable, authorizing the Notified Body to access the Design Dossier and related documentation on the basis of which the PRECISE® Carotid Stent System is CE marked.  SRM warrants that information accessed shall be used solely for the purposes of referencing the clinical data and other information contained in the 

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Design Dossier and related documentation for the purposes of CE marking of Licensed Products.
		
	1.28.
	“Letter of Authorization” shall mean a letter from Cordis to SRM authorizing the FDA or any comparable foreign authority to reference the clinical data and other information contained in the Cordis PMA, or otherwise on file with any foreign Regulatory Authority in a jurisdiction in which SRM is seeking regulatory clearance or approval to market a Licensed Product or Licensed Method for the purpose of facilitating FDA approval of the SRM PMA, any SRM PMA Supplements, or marketing authorization, clearance, approval, permit or license, as the case may be.

		
	1.29.
	“SRM PMA” shall mean PMA Approval and PMA Supplement Approval of a PMA Application or PMA Supplement, as the case may be, for the Licensed Product.

		
	1.30.
	“Design Dossier” shall mean the compilation of technical documentation per Council Directive 93/42/EEC as last amended, and related notices of change submitted to the notified body for conformity assessment and/or design examination of the Cordis PRECISE® Carotid Stent System or any aspect thereof.

		
	1.31.
	“Improvement” shall mean any modification to or derivative of the Cordis PRECISE® Carotid Stent System.

		
	1.32.
	“BSI” shall mean the British Standards Institution.

		
	1.33.
	“PRECISE® Carotid Stent System” shall mean the PRECISE® Carotid Stent System, the PRECISE RX® Carotid Stent System, and/or the PRECISE PRO RX® Carotid Stent System.

		
	1.34
	[***********]

		
	1.35
	[***********]

2.    LICENSE GRANTS
		
	2.1.
	(a) Cordis hereby grants to SRM and its Affiliates, solely within the SRM Field, a worldwide, non-exclusive, royalty-bearing license, without the right to sublicense, to make, have made, use (including but not limited to testing, experimenting and conducting clinical trials), market, offer for sale, sell, have sold, distribute, have distributed, import and have imported, Licensed Products and to practice Licensed Methods, and otherwise to commercialize and exploit the Licensed IP in the SRM Field.

		
	(b)
	Cordis grants to SRM a non-exclusive license to reference, in any SRM regulatory filing made with any Regulatory Authority having jurisdiction over a Licensed Product or Licensed Method (including but not limited to as part of the SRM PMA) in each jurisdiction where SRM seeks regulatory approval, and as part of any 

-5-

application, subsequent amplification, variation or extension of a CE mark for a Licensed Product: the clinical data, material and any other information contained in the Cordis PMA, the Design Dossier and related documentation on the basis of which the PRECISE® Carotid Stent System is PMA approved, CE marked, or in any other regulatory submission applicable to the PRECISE® Carotid Stent System that is on file with a Regulatory Authority.
		
	2.2.
	Despite the nominally ‘non-exclusive’ nature of the license granted hereunder, Cordis expressly agrees that it will not license the Licensed IP within any portion of the SRM Field to any other third party during the Term of this License Agreement.

		
	2.3.
	For clarity, Sections 2.1 and 2.2 do not affect Cordis’ right to continue to develop, in-license, market and sell any current or future product, including the right to make, have made, use, market, offer for sale, sell, have sold, distribute, have distributed, import and have imported products, including those covered by the Licensed IP in any and all fields, or out-license any current or future product outside the SRM Field.

		
	2.4.
	Nothing in this Agreement shall be construed to confer any rights upon SRM by implication, estoppel or otherwise as to any technology or intellectual property rights of Cordis, beyond the express licenses granted to SRM and its Affiliates herein.

3.    MONETARY CONSIDERATION & ROYALTIES
		
	3.1.
	License Fee.  Within ten (10) days of execution of the Agreement, SRM shall provide to Cordis a License Execution Fee of [*********]. This Fee shall not be creditable against any other payment to be made under this Agreement and shall not be refundable for any reason other than either (i) an Arbitrator may award a refund of the license execution fee, in whole or in part, for a finding of material breach pursuant to Dispute Resolution prior to FDA approval of the Licensed Product, or (ii) by mutual agreement of the Parties.

		
	3.2.
	Royalty.  SRM shall pay to Cordis, on a calendar quarter basis during the Term of the Agreement, royalties equal to [*********] of Net Sales during the preceding quarterly period.  SRM shall pay such royalties to Cordis within sixty (60) days following the end of such preceding quarterly period.

		
	3.3.
	Taxes.  Cordis shall be responsible for any and all tax consequences associated with the payment of fees and royalties by SRM under this Agreement.

		
	3.4.
	Royalty Reports.  Within sixty (60) days following the end of each calendar quarter in which a commercial sale of a Licensed Product or Licensed Method has been made, SRM shall deliver to Cordis a written report showing at least (i) the Gross Sales and Net Sales during such calendar quarter, and (ii) the amount of any royalties due to Cordis for such calendar quarter.

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	3.5.
	Payments.  All payments due Cordis shall be payable in United States Dollars, in immediately available funds, by wire transfer in accordance with written instructions provided by Cordis to SRM not less than two (2) business days prior to the due date of such payment.  If Cordis fails to provide such written notice, payment shall be made to Cordis at Cordis’ corporate office: 430 Route 22 East, Bridgewater, NJ 08807-0908 Attn: VP Finance.  As to Net Sales made in any country outside the United States in local currency, the applicable earned royalty shall be converted from local currency into United States Dollars at the applicable exchange rate published in the Wall Street journal on the last business day of the subject quarter.

4.    ROYALTY AUDITS
		
	4.1.
	Upon the written request of Cordis and not more than once in each calendar year, SRM shall permit an independent certified public accounting firm selected by Cordis and reasonably acceptable to SRM, at Cordis’ expense, to have access during normal business hours to such of the records of SRM as may be reasonably necessary to verify the accuracy of the royalty reports for any year ending not more than twenty-four (24) months prior to the date of such request.  The accounting firm shall disclose to Cordis only whether or not the reports are correct and/or the amount of any discrepancies.  All findings by the accounting firm shall be shared with SRM.

		
	4.2.
	If such accounting firm concludes that additional royalties were owed during any particular period, SRM shall pay the additional royalties within thirty (30) days of the date of the accounting firm’s written report.  The fees charged by such accounting firm shall be paid by Cordis; provided, however, that if the audit discloses that the royalties payable by SRM for the audited period are more than ten percent (10%) higher than the royalties actually paid for such period, then SRM shall pay the reasonable fees and expenses charged by such accounting firm for the audit and shall pay interest on the amount of royalties not previously paid but identified as payable as a result of the audit, at a rate of two percent (2%) per annum.

		
	4.3.
	Cordis shall treat, and Cordis shall cause the accounting firm to treat, all financial information subject to review under this Audit right as confidential to SRM, under Section 9 (“Confidentiality”) below.

5.    OWNERSHIP AND PROSECUTION OF PATENT RIGHTS
		
	5.1.
	Cordis acknowledges that SRM has certain intellectual property rights to the SRM Technology.  SRM shall retain all rights in the SRM Technology.  SRM acknowledges that Cordis has certain intellectual property rights to the Cordis Technology, including to the Cordis Patent Rights.  Cordis shall retain all rights in the Cordis Technology, subject to the licensed rights granted to SRM herein.

		
	5.2.
	Any inventions, improvements, or ideas made or conceived by Cordis, individually or jointly with SRM as part of, or during work performed under, this Agreement, that 

-7-

(i) incorporates only the SRM Technology, or (ii) is considered an improvement only of the SRM Technology, shall be solely owned by SRM.  Cordis shall disclose all such inventions, improvements, and ideas, whether or not patentable, promptly to SRM, and Cordis hereby assigns to SRM all of Cordis’ rights, title and interest in and to each such invention, improvement, and idea.
		
	5.3.
	Any inventions, improvements, or ideas made or conceived by SRM, individually or jointly with Cordis as part of, or during work performed under, this Agreement, that (i) incorporates only the Cordis Technology or (ii) is considered an improvement only of the Cordis Technology, shall be solely owned by Cordis.  To the extent that any invention, improvement or idea under this section is also considered an Improvement of Licensed IP, it shall be licensed to SRM under this Agreement. SRM shall disclose all such inventions, improvements, and ideas, whether or not patentable, promptly to Cordis, and SRM hereby assigns to Cordis all of SRM’s rights, title and interest in and to each such invention, improvement, and idea.

		
	5.4.
	Cordis and SRM shall jointly own any new inventions, improvements or ideas that are made or conceived as part of, or during work performed under, this Agreement, that (i) incorporate both Cordis Technology and SRM Technology, or (ii) are considered an improvement of both Cordis Technology and SRM Technology (“Joint Inventions”).  To the extent that any Joint Inventions include Licensed IP, they shall be licensed to SRM under this Agreement.  Unless so licensed under this Agreement, each Party can make (have made), use, offer for sale, sell (have sold) or import (have imported) any product or method constituting a Joint Invention; provided, however, that (a) SRM and any SRM assignee/successor expressly agrees not to make (have made), use, offer for sale, or sell (have sold) or import (have imported) any product or method constituting one or more Joint Inventions outside the SRM Field, nor shall SRM or any SRM assignee/successor transfer to any third party any rights (for example, by license, assignment or sale) to Joint Inventions outside the SRM Field; and (b) Cordis expressly agrees not to make (have made), use, offer for sale, or sell (have sold) or import (have imported) any product or method constituting one or more Joint Inventions within the SRM Field, nor shall Cordis transfer any rights to any third party (for example, by license, assignment or sale) to Joint Inventions within the SRM Field; and (c) the restrictions in subsections 5.4(a) and (b) shall survive termination of this Agreement.  Each Party shall disclose all Joint Inventions, whether or not patentable, promptly to one another.  In the event that any Joint Invention is not jointly owned by Cordis and SRM as a matter of law, Cordis hereby assigns to SRM an undivided joint ownership interest in all of Cordis’ rights, title and interest in and to any Joint Invention that is made or conceived solely by Cordis as part of, or during work performed under, this Agreement, and SRM hereby assigns to Cordis an undivided joint ownership interest in all of SRM’s rights, title and interest in and to any Joint Invention that is made or conceived solely by SRM as part of, or during work performed under, this Agreement.

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	5.5.
	Each Party agrees that it will, within a reasonable timeframe upon the request of the other Party, take all reasonable steps, including executing all necessary documents, to fully effectuate the foregoing ownership provisions concerning separately and jointly owned inventions, improvements or ideas.

		
	5.6.
	(a) Each Party shall be responsible, at its sole expense and discretion, for the protection, including, if said Party so desires, the preparation, filing, prosecution and maintenance of all patent applications and patents (i) solely within that Party’s respective Technology, and (ii) solely owned by that Party, using legal counsel of that Party’s choice.  Each Party shall have no obligation whatsoever to prepare, file, prosecute, or maintain any patent application or patent within its own Technology.

		
	(b)
	The Parties shall jointly protect and maintain all Joint Inventions, which may include the filing, prosecution and maintenance of patents and patent applications for Joint Inventions.  Accordingly, the Parties shall meet, confer and act together as a composite party for all protection, prosecutorial, and/or maintenance matters related to Joint Inventions, including determining if a Joint Invention should be maintained as a trade secret or filed in a patent application.  To this end, each Party agrees that it will take all reasonable steps, including executing all necessary documents, to prepare, file, prosecute, and maintain all patent applications and patents concerning such Joint Invention.  Each Party further undertakes to consider, in good faith, any reasonable requests by the other Party to file and prosecute any patent claims within the Joint Inventions that may be particularly beneficial to the requesting Party.

		
	(c)
	The Parties agree to use patent counsel reasonably acceptable to both SRM and Cordis and shall equally share all expenses in connection with the preparation, filing and prosecution of patent applications that claim patentable, jointly owned Joint Inventions.  In the event that one party declines to equally share the expenses related to the preparation, filing and prosecution of patent applications that claim patentable, jointly owned Joint Inventions (“Declined Applications”), that Party shall provide the other Party with reasonable notice of such determination, which shall be at least thirty (30) days where reasonably possible, in advance of any deadline to prosecute or maintain any such patent or patent application, and the other Party shall have the option to prosecute or maintain such patent or patent application, as applicable, at its own expense.  If the other Party exercises the foregoing option to prosecute and maintain said Declined Applications, then the Party providing the initial notice agrees to surrender and relinquish all control and decision making to the other Party with regard to the filing, prosecution and maintenance of said Declined Applications.  For avoidance of doubt, the Party providing the initial notice shall not lose any rights to any patents issuing from said Declined Applications.

		
	(d)
	In the case of foreign patents and patent applications that are part of the Joint Inventions, if either Party elects to file, prosecute or maintain a foreign patent or patent application in a foreign country or jurisdiction that is not agreed upon by both Parties (“Other Foreign Applications”), the electing Party shall bear all costs of filing, 

-9-

prosecution and maintenance of such Other Foreign Applications in that foreign country or jurisdiction, and shall fully control and make all decisions with regard to the filing, prosecution and maintenance of said Other Foreign Applications in that foreign country or jurisdiction.  For avoidance of doubt, the non-electing Party shall not lose any rights to any patents issuing from said Other Foreign Applications.
6.    COOPERATION BETWEEN PARTIES
		
	6.1.
	Manufacturer. (a) Subject to Section 6.5, SRM will work exclusively for development, manufacture and supply of Licensed Products and Licensed Methods with either (i) Cordis; or (ii) Nitinol Devices and Components, Inc. (“NDC”) (“Manufacturer”).  The consent by Cordis to participate as a Manufacturer shall be at the sole discretion of Cordis.  In the event development begins with one of the above entities and then that entity cannot continue for some reason, SRM can seek a third party manufacturer (who shall also be considered a “Manufacturer” under this Agreement), but only with the advanced written consent of Cordis, such consent shall not be unreasonably withheld.

		
	(b)
	Cordis shall transfer to Manufacturer, upon reasonable request by Manufacturer from time to time, (i) any and all manufacturing and other know-how that exists and is under Cordis’ Control as of the Effective Date, and (ii) any and all manufacturing and other know-how that is developed after the Effective Date, that pertains to the PRECISE® Carotid Stent System, and is within Cordis’ Control at the time of the request, in either case that is necessary for Manufacturer to develop, manufacture and supply the Licensed Products and Licensed Methods for SRM; provided, however, Manufacturer shall not disclose such know-how to SRM or any third party, and Manufacturer shall execute an appropriate confidentiality agreement (“Manufacturer Confidentiality Agreement”) between Cordis and Manufacturer.  Notwithstanding the foregoing, Manufacturer shall be free to disclose to SRM within Manufacturer’s discretion, and to use on SRM’s behalf without restriction, any know-how developed by Manufacturer and/or SRM after the Effective Date that is relevant or useful to the development, manufacture or supply of Licensed Products and Licensed Methods that does not disclose the manufacturing or other know-how of Cordis or violate the Manufacturer Confidentiality Agreement between Cordis and Manufacturer.

		
	6.2.
	Technical Information Rights. (a) In order to facilitate regulatory approval of any Licensed Product or Licensed Method, Cordis shall provide to SRM:

(1)    A Letter of Authorization; and
(2)    A Right of Access Letter.
Any Letter of Authorization, Right of Access Letter or other information provided by Cordis under this subparagraph 6.2 shall be used solely for the purpose of allowing a Regulatory Authority to access the clinical data and other information contained in 

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the Design Dossier, Cordis PMA, or other regulatory body registration or licensing submission and/or related documentation for the purposes of regulatory clearance or approval of the Licensed Products.
		
	(b)
	Notwithstanding anything to the contrary, any information shall be limited to information within Cordis’ possession or control that relates directly to the Licensed IP and that is reasonably required for the development, manufacture and/or commercialization of Licensed Products and Licensed Methods in the SRM Field, and SRM will have the right to reference such information for the purposes of such development, manufacture and commercialization of Licensed Products and Licensed Methods in the SRM Field under the Agreement.  Disclosure of any information from Cordis to SRM will be subject to the confidentiality provisions of Section 9 of this Agreement; provided, however, that the confidentiality provisions shall not be construed to prevent or restrict SRM from obtaining or maintaining regulatory approval of Licensed Products and Licensed Methods as contemplated by this Agreement or from complying with its obligations under Section 6.4(d).

		
	(c)
	Cordis shall promptly notify SRM and NDC, as the case may be, of any process or design changes that are directly related to, and may affect the manufacture of, the PRECISE® Carotid Stent System being manufactured and sold as of the time of execution of this Agreement.

		
	(d)
	(1) The Parties acknowledge and agree that during the term of this Agreement, (i) SRM shall be responsible for development of, all development costs of, and all costs related to and arising from obtaining necessary regulatory approval for, the Licensed Products and Licensed Methods;

(ii)    at SRM’s reasonable request and at SRM’s expense, Cordis shall provide to SRM assistance and advice using Cordis information then on-hand, concerning the Cordis PRECISE® Carotid Stent System and its use in development of the first Licensed Product or Licensed Method; and
(iii)    after SRM receives regulatory approval for the first Licensed Product or Licensed Method in any jurisdiction, upon SRM’s reasonable request and at SRM’s expense, Cordis shall provide further assistance and advice using Cordis information then on-hand, concerning the Cordis PRECISE® Carotid Stent System and its use in development of the any Licensed Product or Licensed Method.
		
	(2)
	Cordis shall provide such assistance under subparagraphs (ii) and (iii) as promptly as reasonably practicable, given Cordis’ circumstances at the time of SRM’s reasonable request.  For the purpose of clarity, if Cordis deems information that could be helpful to SRM under Section 6.2(d)(1) to be proprietary to Cordis, and if Cordis is not otherwise inclined to share same with SRM under the terms of, and to further the purposes of, this Agreement, the Parties shall discuss in good faith how to proceed.

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	6.3.
	Development Plan. (a) SRM agrees to undertake the development of the Licensed Products and Licensed Methods at its own cost and expense.

		
	(b)
	Within thirty (30) days after the end of each calendar year, SRM shall provide Cordis with written reports setting forth in reasonable detail the progress made in the development of Licensed Products and Licensed Methods.  Disclosure of such written reports from SRM to Cordis will be subject to the confidentiality provisions of Section 9 of this Agreement.  Each such report shall include, without limitation, a description of all studies conducted during the period covered by the report, and a reasonable summary of data generated as part of the Licensed Product and Licensed Method development efforts during the period covered by the report.

		
	6.4.
	Regulatory Matters.  (a) SRM shall be solely responsible for (and shall use its reasonable efforts, and at its sole expense) all activities required to obtain regulatory approval of the Licensed Products and Licensed Methods.

		
	(b)
	SRM shall, at its sole expense, be responsible for the preparation and filing, in its own name, with the appropriate regulatory authorities, all documents, including without limitation, all regulatory filings that are necessary to conduct clinical studies of Licensed Products and Licensed Methods and applications for regulatory approval that are necessary to market and sell Licensed Products and practice Licensed Methods in covered geographies.

		
	(c)
	When necessary, Cordis shall authorize the FDA to reference Cordis’ annual PMA reports or will provide to SRM any documents that will be reasonably required by SRM to fulfill its PMA annual reporting obligations.  Cordis’ assistance shall be reasonable and limited to documents within Cordis’ possession or control.

		
	6.5.
	Compliance with Law. (a) Each Party shall comply in all material respects with all applicable Laws and, except as provided for herein, shall bear its own cost and expense of complying therewith.

		
	(b)
	The termination or expiration of this Agreement shall not relieve either Party of its responsibility to comply in all material respects with any statutory or regulatory requirements associated with the Licensed Products or Licensed Methods.

		
	6.6.
	Handling of Customer Complaints / Medical Device Reporting / Adverse  Reaction and Device Defect Reporting. (a) Each party shall reasonably cooperate fully with the other party in dealing with customer complaints concerning the Licensed Products, Licensed Methods and/or the Cordis PRECISE® Carotid Stent System and shall take reasonable action to promptly resolve and follow up with regard to such complaints.

		
	(b)
	SRM shall be responsible for complying with adverse event reporting requirements for Licensed Products, including the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (“MDR”), or the 

-12-

reporting requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, the applicable Laws of EU Member States and relevant European Commission guidelines, for the Licensed Product.
		
	(c)
	Cordis shall provide such assistance and information as SRM reasonably requests to fulfill its adverse event reporting obligations for Licensed Products and Licensed Methods. Without limiting the generality of the foregoing, Cordis shall: (1) keep and maintain a record of all customer complaints received by Cordis relating to the Cordis PRECISE® Carotid Stent System that are required to be maintained by Cordis pursuant to 21 C.F.R. § 820.198, or comparable Laws or equivalent regulations applicable in third countries; (2) notify SRM immediately upon receipt of any information, including adverse event reports, field safety corrective actions and customer complaints, that indicates a material safety concern with respect to the Cordis PRECISE® Carotid Stent System that could have a significant effect on the safety or efficacy of any Licensed Product or Licensed Method; and (3) otherwise cooperatively undertake investigations with SRM, provide information and analysis to SRM, and conduct such follow-up activities as reasonably requested by SRM in fulfillment of SRM’s obligations under this Section 6.5.

		
	(d)
	Regardless of whether the complaint information was received by SRM or Cordis, SRM shall: (1) keep and maintain a record of all customer complaints relating to any Licensed Product or Licensed Method that are required to be maintained by SRM pursuant to 21 C.F.R. § 820.198 or comparable Laws or equivalent regulations applicable in third countries; (2) notify Cordis upon receipt of any information that indicates a customer complaint, field safety corrective actions or material safety concern with respect to any Licensed Product or Licensed Method that could have a significant effect on the safety or efficacy of the Cordis Technology; and (3) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Cordis in fulfillment of Cordis’ obligations pursuant to this Section 6.6.

		
	6.7.
	Removals and Corrections (Recalls).  (a) If either party, is ordered by a competent authority or in good faith determines that a removal from the market, correction or other field action involving a Licensed Product, Licensed Method or the Cordis PRECISE® Carotid Stent System is warranted, such party shall immediately notify the other party in writing and shall advise such other party of the reasons underlying its determination that a removal, correction or other field action is warranted.  The parties shall consult with each other as to any action to be taken in regard to such removal, correction or other field action.  If after consultations: (1) SRM in good faith believes that such a removal, correction or field action should be undertaken with respect to a Licensed Product or Licensed Method, the parties shall cooperate in carrying out the same; or (2) Cordis in good faith believes that such a removal, correction or field action should be undertaken with respect to the Cordis PRECISE® Carotid Stent System, the parties shall cooperate in carrying out the same.  Any 

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removal, correction or other field action shall be carried out within the timeline applicable in the concerned jurisdiction.
		
	(b)
	SRM and Cordis shall submit to the FDA any necessary reports of removals, corrections or other field actions, as required under 21 C.F.R. Part 806, and shall be responsible for drafting any notifications of removals and corrections with respect to: (1) a Licensed Product or Licensed Method; and (2) the Cordis PRECISE® Carotid Stent System, respectively.  Each party shall within a reasonable time thereafter provide the other party with a copy of all such reports as filed with the FDA, with the exception of any confidential, trade secret or proprietary information. Each party shall maintain records of all corrections or removals as required by Law, and shall promptly provide the other party with a copy of such records, with the exception of any confidential, trade secret or proprietary information.

		
	6.8.
	Distribution.  With respect to each country or other jurisdiction where SRM markets and/or distributes (directly or indirectly) any Licensed Product or Licensed Method, SRM agrees to (i) identify SRM as the manufacturer of the Licensed Product or the source of the Licensed Method in all filings with the appropriate Regulatory Authorities and/or correspondence as may be required, (ii) comply with all laws relating to the distribution of the Licensed Products and Licensed Methods in each such country or jurisdiction, and (iii) identify SRM as the “manufacturer” of the Licensed Products and the source of the Licensed Methods in the labels, directions for use, package inserts, marketing materials or any other materials accompanying or promoting the Licensed Products and or Licensed Methods.

7.    WARRANTIES AND DISCLAIMER
		
	7.1.
	SRM Representation and Warranty.  SRM represents and warrants that all persons employed by, or serving as consultants to, SRM who shall have access to Cordis Technology shall have executed a written agreement requiring each such person to assign to SRM all of such person’s right, title and interest in and to any intellectual property rights in SRM Technology prior to having access to Cordis Technology.

		
	7.2.
	Cordis Representation and Warranty.  Cordis represents and warrants that (a) all persons employed by, or serving as consultants to, Cordis who shall have access to SRM Technology shall have executed a written agreement requiring each such person to assign to Cordis all of such person’s right, title and interest in and to any intellectual property rights in Cordis Technology prior to having access to SRM Technology; and

(b) all patent rights, pending or issued, that concern any aspect of the PRECISE® Carotid Stent System are included in Exhibit A to this Agreement.  To the extent any such rights in existence as of the Effective Date are not included and are later discovered, such shall be added to Exhibit A at that time and shall be treated as if included in Exhibit A from the Effective Date of this Agreement.

-14-

		
	7.3.
	DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED HEREIN: (i) SRM AGREES THAT THE CORDIS LICENSE TO SRM OF THE CORDIS PATENT RIGHTS ARE GRANTED “AS IS;” AND (ii) NEITHER PARTY, NOR THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, TITLE, VALIDITY OF PATENT RIGHTS OR CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE.

		
	7.4.
	Mutual Representations and Warranties.  Each Party represents and warrants to the other that: (i) it is duly organized, validly existing, and in good standing in the jurisdiction in which it is incorporated, (ii) it has full corporate power and authority to carry on its business as presently conducted and as contemplated in this Agreement, to execute and deliver this Agreement, and to perform its obligations hereunder; (iii) the execution, delivery and performance of this Agreement have been authorized and approved by its Board of Directors and do not and will not (A) violate any law, rule, regulation, order, decree or permit which is applicable to it or (B) violate its organizational documents or any agreement to which it is a party; and (iv) this Agreement is a legal and binding obligation of it, enforceable against it in accordance with its terms, except to the extent enforceability is modified by bankruptcy, reorganization and other similar laws affecting the rights of creditors generally and by general principles of equity.

8.    COMMERCIALIZATION; USE OF NAMES
		
	8.1.
	Cordis.  Cordis shall not use the name of SRM or any of its Affiliates, employees or agents in any advertising, promotional or sales literature, or publication without the prior written consent of SRM.

		
	8.2.
	SRM.  (a) SRM shall not use the names of Cordis or any of its Affiliates, employees or agents, in any advertising, promotional or sales literature or publication without the prior written consent of Cordis. SRM shall, at its own expense, be solely responsible for the manufacture, promotion, marketing, distribution and sale of each Licensed Product and Licensed Method.  Unless otherwise agreed to with Cordis, SRM shall promote, market, distribute and sell each Licensed Product and Licensed Method under its own trade name and a trademark of its choice, provided, however, that such trademark shall not be confusingly similar to any trademark owned or used by Cordis or any of Cordis Affiliates.

		
	(b)
	SRM shall include, on the packaging and label of each Licensed Product, a statement indicating that such Licensed Product is being made, distributed and sold by SRM pursuant to a license from Cordis.  The statement shall be in both form and substance acceptable to Cordis.

-15-

		
	(c)
	Notwithstanding any of the above, SRM shall be able to promote published clinical data related to the PRECISE® Carotid Stent System in conjunction with the marketing of each Licensed Product and Licensed Method subject to Cordis’ review and approval, said approval not to be unreasonably withheld or delayed.

		
	(d)
	Patent Marking.  SRM shall affix to all of its Licensed Products made, used, sold, offered for sale or imported into the U.S. (and/or all labeling and/or packaging thereof), where appropriate and in accordance with U.S. patent law, marking notices of all of the U.S. patent rights including the Cordis Patent Rights practiced by such Licensed Product (Patent Marking Statement).  Before so marking its Licensed Products, SRM will review the Patent Marking Statement with Cordis. SRM shall be solely responsible for the accuracy of the Patent Marking Statement, and provided that Cordis does not modify in any way the Patent Marking Statement proposed by SRM, SRM shall be solely liable for any damages assessed or incurred that result from an improper Patent Marking Statement.

9.    CONFIDENTIALITY
		
	9.1.
	Confidential Information.  Both Cordis and SRM agree that all information disclosed to the other Party shall be deemed “Confidential Information” of the disclosing party.  In particular, “Confidential Information” shall be deemed to include, but not be limited to, any invention disclosures, unpublished patent applications, trade secrets, information, ideas, inventions, materials, samples, processes, procedures, methods, formulations, protocols, packaging designs and materials, test data, future development plans, product launch dates, technological know-how and engineering, manufacturing, regulatory, marketing, servicing, sales, or financial matters relating to the disclosing party and its business.

		
	9.2.
	Nondisclosure and Nonuse.  During the Term and for five (5) years following its termination or expiration (“Confidentiality Period”), each Party shall maintain all Confidential Information in confidence and shall not disclose any Confidential Information to any third party (other than its Affiliates and sub-licensees of the licensed rights) or use any such information for any unauthorized purpose.  Each Party may use such Confidential Information only to the extent required to accomplish the purposes of this Agreement.  Both Parties shall take precautions as each normally takes with its own confidential and proprietary information to prevent disclosure to third parties, but no less than reasonable precautions.  Notwithstanding the above, the Parties agree that SRM may reveal this Agreement (i) to a potential investor, strategic partner or in connection with a potential or actual Exit Transaction, provided that any such third party shall execute an appropriate nondisclosure agreement beforehand, and (ii) in connection with obtaining or maintaining regulatory approval for the Licensed Products and Licensed Methods and with its obligations under Section 6.4(d).

-16-

		
	9.3.
	Exceptions.  Both Parties agree that, notwithstanding the above, the obligations of confidentiality and nonuse shall not apply to:

		
	9.3.1.
	Information that at the time of disclosure is, or thereafter becomes, generally known or available to the public, through no wrongful act or failure to act on the part of the receiving Party;

		
	9.3.2.
	Information known by or in the possession of the receiving Party at the time of receiving such information from the disclosing Party, as evidenced by written records;

		
	9.3.3.
	Information obtained by the receiving Party from a third-party source who is not breaching a commitment of confidentiality to the disclosing Party by revealing such information to the receiving Party, as evidenced by written records;

		
	9.3.4.
	Information required to be disclosed pursuant to applicable law, regulation (including the requirements of the U.S. Securities and Exchange Commission and the listing rules of any applicable securities exchange), court order or compulsory discovery process; provided, however, each Party may only disclose information as specifically required and necessary to be disclosed, and with respect to information disclosed pursuant to a court order or compulsory discovery process, the Party required to make the disclosure shall provide notice thereof to the other Party and shall use reasonable efforts to obtain confidential treatment of the disclosed information.

		
	9.3.5.
	Information SRM discloses to any regulatory agency in connection with facilitating regulatory approval or CE marking for the Licensed products and Licensed Methods under Section 6 above; provided, however, that the obligations of confidentiality and non-use shall remain applicable to any such information that is treated as confidential information by the Regulatory Authority to which it is disclosed.

		
	9.4.
	Employees, Agents and Consultants.  Both parties shall make diligent efforts to ensure that all employees, agents and consultants who may have access to Confidential Information of the other party, and any other third parties who might have access to Confidential Information, shall sign nondisclosure agreements consistent with the terms set forth in this Section 9.  No Confidential Information shall be disclosed to any employees, agents, consultants or third parties who do not have a need to receive such information for the purposes of this Agreement.

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10.    RIGHT OF FIRST NEGOTIATION
		
	10.1.
	(a)(i) SRM may notify Cordis, in writing from time to time, that SRM wishes to offer to Cordis a period of thirty (30) days of exclusivity to execute a term sheet for an Exit Transaction with Cordis.  If Cordis and SRM do not execute such a term sheet during that period of exclusivity, then SRM would have a subsequent 180 day window in which to offer an Exit Transaction to any other party, provided that SRM may not sign a definitive agreement for an Exit Transaction with a third party unless SRM first provides Cordis with written notice of the material terms of the proposed Exit Transaction and Cordis fails to execute a definitive, fully binding term sheet acceptable to SRM to enter into an Exit Transaction with SRM within fifteen (15) business days after receiving such notice. During the 180 day window, SRM and Cordis could choose to continue their discussions, albeit on a nonexclusive basis.

		
	(i)
	The procedure set forth in section 10.1(a)(i) shall be referred to as the “Right of First Negotiation.”

		
	(b)
	If, and only if, SRM does not execute a term sheet for an Exit Transaction with a third party during the subsequent 180 day period, then the Right of First Negotiation shall reset.

		
	(c)
	Notwithstanding anything in this section 10, SRM shall have no right to execute a term sheet for an Exit Transaction with a third party without first providing the Right of First Negotiation to Cordis.

		
	(d)
	The Right of First Negotiation shall terminate upon an Initial Public Offering of SRM.

11.    TRANSFERABILITY
		
	11.1
	[************]

		
	11.2
	[************]

		
	11.3
	[************]

		
	11.4
	[************]

		
	11.5
	[************]

		
	11.6
	[************]

		
	11.7
	[************]

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12.    TERMINATION
		
	12.1.
	Term.  The license granted to SRM and all of the obligations for the parties shall be effective as of the Effective Date of the Agreement, and shall remain in full force and effect on a country by country basis until the last to expire of the Licensed IP in such country, unless earlier terminated, either (i) by mutual written agreement of the parties or (ii) as otherwise provided for in this Agreement (“Term”).

		
	12.2.
	(A) Either Party may terminate the Agreement upon written notice provided to the other party at any time during the Term upon sixty (60) days’ written notice (“Notice Period”) if (i)the other Party commits a material breach of this obligation and such breach remains uncured for the Notice Period, or (ii) SRM fails to diligently pursue commercialization of the Licensed IP by failing to submit an IDE filing for a Licensed Product with the FDA, or commence a clinical trial to collect data to support a PMA submission on a Licensed Product, within twenty-four (24) months of the later of (1) the Effective Date of this Agreement, or (2) the date of execution of a development/manufacture/supply agreement with a Manufacturer under Section 6.1, or (iii) SRM fails to have a commercially available and approved Licensed Product in the United States within sixty (60) months of the later of (1) the Effective Date of this Agreement, or (2) the date of execution of a development/manufacture/supply agreement with a Manufacturer under Section 6.1; provided, however, that for subsections (i), (ii) and (iii), (1) during the Notice Period, the Parties shall meet and confer in good faith in order to attempt to resolve any disagreement, and (2) a Party’s right to terminate the Agreement shall be tolled from the date of presentation of a Notice of Dispute under the Dispute Resolution provisions of this Agreement through actual final resolution of the Dispute; or (iv) upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, termination of business operations, or upon an assignment of a substantial portion of the other Party’s Technology for the benefit of creditors by the other Party, or in the event a receiver or custodian is appointed for such other Party’s business, or if a substantial portion of such other Party’s business is subject to attachment or similar process. In order for Cordis to terminate this Agreement pursuant to clause (i) or (ii) or (iii), Cordis must include a detailed explanation of such material breach or alleged lack of diligence in the written notice of such termination it provides to SRM.

(B) If SRM fails to timely make any payment Cordis believes is due under this Agreement, Cordis may terminate for material breach under section 12.2(A)(i), provided, however, that the written Notice Period under these circumstances shall be thirty (30) days instead of sixty (60) days.  If the Agreement is terminated under this subsection, for the purpose of clarity, SRM and SRM’s assignee/successor shall be precluded from selling, leasing, transferring or otherwise disposing any Licensed Products or Licensed Methods in inventory under section 12.4.
		
	12.3.
	In addition, if Cordis materially breaches this Agreement, after the requisite sixty (60)-day Notice Period, SRM may elect (i) to keep the Agreement in effect in order to 

-19-

continue to pursue its purpose, and (ii) to pay all further consideration due Cordis under this Agreement into an Escrow account under control of a neutral, independent third party mutually agreed to by the Parties.  If SRM elects to take this path, the funds in the Escrow account shall be released by the neutral third party only upon (i) mutual agreement of the Parties, as conveyed in writing by both Parties, or (ii) to the prevailing party upon an order resulting from the arbitration proceeding under Dispute Resolution. SRM’s election to proceed under this subsection 12.3 shall not derogate or otherwise adversely affect or detract from any other right, remedy, claim or cause of action one Party may have against the other Party for material breach under the terms of this Agreement.
		
	12.4.
	Effects of Termination.  (a) Upon termination of this Agreement for any reason: (i) nothing herein shall be construed to release either Party from any obligation that matured prior to the effective date of termination; (ii) Sections 5, 9, 12, 13, and 14 shall survive any termination according to their respective terms; and (iii) except for Confidential Information a Party reasonably needs to continue to exercise the licenses granted herein that survive termination, each Party shall immediately return all Confidential Information to the disclosing Party and shall cease and refrain from any further use of such Confidential Information, provided, however, that one copy of the other Party’s Confidential Information may be retained within the Party’s legal archives for purposes solely related to ensuring compliance with this Agreement until the expiration of the Confidentially Period.

		
	(b)
	After the effective date of any termination of this Agreement, other than a termination for purposes of requiring a Replacement Product as set forth in Section 11 or termination for failure to make any payment due under this Agreement, SRM or its assignee/successor shall have six (6) months to sell, lease, transfer or otherwise dispose of all Licensed Products and Licensed Methods that are completed and in inventory at the time of termination.  SRM shall duly account to Cordis for the disposition of such Licensed Products, Licensed Methods and inventory in its possession as of the date of termination, and shall pay any royalties due as if this Agreement remained in effect.  The first such report shall be due within ninety (90) days of the termination of this Agreement, with updated reports due each subsequent ninety (90) day period thereafter until the earlier of (i) the six (6) month anniversary of the termination date, or (ii) disposition of all such Products completed and in inventory as of the date of termination.

13.    DISPUTE RESOLUTION
		
	13.1.
	Any controversy or claim arising out of or relating to this Agreement, including any such controversy or claim involving the parent company, subsidiaries, or affiliates under common control of any Party (a “Dispute”), if not resolved through good faith discussion between the Parties, shall first be submitted to mediation according to the Commercial Mediation Procedures of the American Arbitration Association (“AAA”) (see www.adr.org).  Such mediation shall be attended on behalf of each party for at 

-20-

least one session by a senior business person with authority to resolve the Dispute. Any period of limitations that would otherwise expire between the initiation of a mediation and its conclusion shall be extended until 20 days after the conclusion of the mediation.
		
	13.2.
	(a) Any Dispute that cannot be resolved by mediation within 45 days of notice by one Party to the other of the existence of a Dispute (unless the parties agree to extend that period) shall be resolved by arbitration in accordance with the Commercial Arbitration Rules of the AAA (“AAA Rules”; see www.adr.org) and the Federal Arbitration Act, 9 U.S.C. §1 et seq.. The arbitration shall be conducted in New Jersey, by one arbitrator appointed in accordance with the AAA Rules.

		
	(b)
	The arbitrator shall follow the ICDR Guidelines for Arbitrators Concerning Exchanges of Information in managing and ruling on requests for discovery.  The arbitrator, by accepting appointment, undertakes to exert her or his best efforts to conduct the process so as to issue an award within eight (8) months of his or her appointment, but failure to meet that timetable shall not affect the validity of the award.  The arbitrator shall decide the Dispute in accordance with the substantive law of New Jersey. The arbitrator may not award punitive or consequential damages, nor may the arbitrator apply any multiplier to any award of actual damages, except as may be required by statute.  The award of the arbitrator may be entered in any court of competent jurisdiction.  The arbitrator shall not award either Party attorneys fees or costs.

		
	(c)
	This manner of dispute resolution (mediation, followed by arbitration) shall be the exclusive method of resolving Disputes between the Parties; provided, however, that in the event of a Party’s violation of any of its obligations under Section 9 (Confidentiality) of this Agreement, (i) the other Party may seek preliminary and permanent injunctive relief relating to such violation in any federal or state court sitting in the State of New Jersey without having to prove actual damages or immediate or irreparable harm or to post a bond, and (ii) the Parties hereby consent to the jurisdiction of such courts in such State and waive any defense of inconvenient forum for any such action brought in any such venue.

		
	(d)
	EACH PARTY UNDERSTANDS AND AGREES THAT THE DISPUTE RESOLUTION PROVISIONS (MEDIATION, FOLLOWED BY ARBITRATION) OF THIS SECTION 13 CONSTITUTE A WAIVER OF ITS RIGHT TO A JURY TRIAL.

14.    GENERAL
		
	14.1.
	Integrated Agreement.  This Agreement (including Appendix A which is incorporated herein by reference) constitutes the complete and exclusive statement of the agreement between the Parties, and supersedes all prior agreements, proposals, 

-21-

negotiations and communications between the Parties, both oral and written, regarding the subject matter hereof.
		
	14.2.
	Waiver or Modification.  No waiver, alteration or modification of any of the provisions of this Agreement shall be binding unless made in writing and signed by each of the Parties hereto.

		
	14.3.
	Notices.  All notices, requests or communications to be given under this Agreement shall be in writing and shall be deemed duly given if sent by prepaid registered or certified mail, return receipt requested, or by prepaid overnight courier service, or by facsimile, with confirmed transmission receipt, to the addresses set forth immediately below (or to such other addresses as the Parties may designate by notice given in accordance with this provision):

If to Cordis:
Cordis Corporation 
430 Route 22 East 
Bridgewater, NJ 08807-0908 
Attn: Vice President, Business Development 
Fax: 908 541 4482
If to SRM:
Silk Road Medical, Inc. 
735 North Pastoria Avenue 
Sunnyvale, California 94085 
Attn: William Worthen, President & Chief Executive Officer 
Fax: (408) 720-9013
All such notices if properly addressed shall be effective when received.
		
	14.4.
	Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey, without regard to conflict of laws principles, and as necessary the laws of the United States of America.

		
	14.5.
	Failure to Exercise Remedy.  If either Party fails to enforce any term of this Agreement or fails to exercise any remedy, such failure to enforce or exercise on that occasion shall not prevent enforcement or exercise on any other occasion.

		
	14.6.
	Cumulative Remedies.  All rights and remedies, whether conferred by this Agreement or by any other instrument or by law shall be cumulative, and may be exercised singularly or concurrently.

		
	14.7.
	Assignment.  (a) Cordis may not assign or transfer this Agreement, in whole or in part, without first receiving the prior written consent of SRM, such consent not to be unreasonably withheld.

-22-

		
	(b)
	SRM may not assign or transfer this Agreement, in whole or in part, other than in connection with an Exit Transaction according to the terms of this Agreement.

		
	(c)
	Any attempted assignment or transfer in derogation of the foregoing shall be null and void.

		
	(d)
	Subject to the foregoing, this Agreement shall be binding on, and inure to the benefit of, the Parties hereto, and their respective successors and permitted assigns.

		
	14.8.
	Independent Contractors.  The Parties agree that, in the performance of this Agreement, they are and shall be independent contractors. Nothing herein shall be construed to constitute either Party as the agent of the other Party for any purpose whatsoever other than as expressly permitted by this Agreement, and neither Party shall bind or attempt to bind the other Party to any contract or the performance of any obligation or represent to any third party that it has any right to enter into any binding obligation on the other Party’s behalf.

		
	14.9.
	Force Majeure.  No Party shall be held liable or responsible to any other Party, nor be deemed to have defaulted under, or breached, this Agreement for failure or delay in fulfilling or performing any term of this Agreement to the extent, and for so long as, such failure or delay is caused by, or results from, causes beyond the reasonable control of the affected Party, including but not limited to fire, floods, embargoes, war, terrorism, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority.

		
	14.10.
	Invalidity.  If any provision of this Agreement is held invalid by any law, rule, order, or regulation of any government or by the final determination of any court of competent jurisdiction, such invalidity shall not affect the enforceability of any other provisions, and any such provision held invalid shall be interpreted or reformed so as to best accomplish the objectives of the parties to this Agreement within the limits of applicable law or applicable court decision.

		
	14.11.
	Drafting.  Each Party represents that it participated equally with the other in the drafting of this Agreement. This Agreement shall be interpreted without regard to any principle of construction regarding the drafting, authorship or revision thereof.

		
	14.12.
	Counterparts.  This Agreement may be executed in one or more counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one and the same agreement.

IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly authorized representatives, to be effective as of the Effective Date.

-23-

	
					
	CORDIS CORPORATION
	 
	SILK ROAD MEDICAL, INC.

	 
	 
	 
	 
	 

	By:
	/s/ Raymond Suehnholz
	 
	By:
	/s/ William Worthen

	 
	 
	 
	 
	 

	Print:
	Raymond Suehnholz
	 
	Print:
	William Worthen

	 
	 
	 
	 
	 

	Title:
	VP Global Strategic Marketing
	 
	Title:
	President & Chief Executive Officer

-24-

APPENDIX A 
CORDIS PATENT RIGHTS
	
			
	US Patent
	Title
	Related OUS issued 
Family members

	US6859986B2
	Method system for loading a self-expanding stent
	EP1462070B1;
JP4405282B2

	US6743219B1
	Delivery apparatus for a self-expanding stent
	AU777433B2 ;
AU780428B2;
EP1181906B1

	US6773446B1
	Delivery apparatus for a self-expanding stent
	AU777433B2;
AU780428B2;
EP1181906B1

	US6942688B2
	Stent delivery system having delivery catheter member with a clear transition zone
	EP1129674B1

	US6019778A
	Delivery apparatus for a self-expanding stent
	AU736076B2;
EP0941716B1

	US6425898B1
	Delivery apparatus for a self-expanding stent
	AU736076B2;
AU758842B2 ;
JP4393655B2;
EP0941716B1;
EP1025813B1

	US6129755A
	Intravascular stent having an improved strut configuration
	AU740593B2;  
EP0928605B1

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