Definitions.

“Affiliate” of a Person is a Person controlling, controlled by or under common control with the Person specified. “Controlling”, “controlled” or “control” means owning greater than 50% of the voting equity interests of a Person, either directly or indirectly through one or more intermediaries in which it has such an interest, or otherwise having the power to direct the management of that Person.

“Arbitrators” has the meaning ascribed thereto in Section 3(F)(iii).

“Billabong Patents” means (i) the Patents listed on Exhibit A, and (ii) any claims of any future Patent which claim and are entitled to claim (in whole but not in part, so long as neither CPI nor any of its Affiliates files any claims in a continuation-in-part Patent which require new matter for support for the primary purpose of avoiding, circumventing, evading or minimizing its payment obligations to SVI hereunder or pursuant the License Agreement) priority to a Patent covered by the preceding clause (i) (e.g., claims in a continuation-in-part Patent which require new matter

“Bionics” means Boston Scientific Neuromodulation Corporation (formerly known as Advanced Bionics Corporation), a wholly-owned indirect subsidiary of Boston Scientific Corporation and an Affiliate of CPI.

“Bionics Agreements” means the following agreements: (i) the Bionics Lead Development Agreement, (ii) that certain Amended and Restated Multiple Advance Secured Convertible Promissory Note dated as of June 30, 2007 made by SVI and payable to Bionics (as may be further amended, restated, supplemented or otherwise modified from time to time), (iii) the Bionics License Agreement, and (iv) that certain Security Agreement dated as of December 30, 2005 by and between SVI and Bionics (as amended by that certain Omnibus Amendment dated as of June 30, 2007, and as may be further amended, supplemented, or otherwise modified from time to time).

“Bionics Amendment” means that certain Omnibus Amendment No. 2 to the Bionics Lead Development Agreement and Bionics License Agreement dated as of the date hereof by and between SVI and Bionics.

“Bionics Lead Development Agreement” means that certain System and Lead Development and Transfer Agreement dated as of December 30, 2005, as amended by that certain Amendment No. 1 dated as of May 31, 2006, as further amended by that certain Omnibus Amendment dated June 30, 2007, as further amended by the Bionics Amendment (as may be further amended, supplemented or otherwise modified from time to time).

“Bionics License Agreement” means that certain License Agreement dated as of December 30, 2005, as amended by that certain Omnibus Amendment dated June 30, 2007, as further amended by the Bionics Amendment (as may be further amended, supplemented or otherwise modified from time to time).

“Bionics Reserved IP” means any BSC Solely Invented Development IP and any Joint Development IP that is, at least in part, conceived or reduced to practice by Bionics (or its employees, agents or consultants).

“Brady Lead” has the meaning ascribed thereto in the Project Plan attached as Exhibit A.

“BSC Controlled IP” means the Patents included in Development IP.

“BSC Core Product Information” means that core product information proprietary to CPI which is listed on Exhibit C hereto (as may be updated from time to time by CPI upon notice to SVI).

“BSC Solely Invented Development IP” means any Intellectual Property Rights conceived or reduced to practice solely (as between the Parties) by CPI or its Affiliates (or their respective employees, agents or consultants) that are (i) related to this Agreement, (ii) primarily related to the Field, or (iii) based on CPI’s or its Affiliates’ Confidential Information.

“Change Control Document” has the meaning ascribed thereto in Section 2(C).

“Change in Control” means any transaction or series of transactions (whether or not related), including a merger, consolidation, exchange, sale of equity securities, recapitalization, sale of assets, dissolution or liquidation, pursuant to which any Person or group of Persons (within the meaning of Section 13(d)(3) of the Securities Exchange Act of 1934, as amended) acquires (directly or indirectly) (i) equity securities possessing the voting power to elect a majority of a Party’s (or a successor’s) board of directors (or equivalent body) or a majority of the voting equity interests in a Party (or a successor thereto) or (ii) all or substantially all of the assets of a Party.

“Change Request” has the meaning ascribed thereto in Section 2(C).

“Claim” means any allegation, demand, investigation, suit, proceeding, claim, settlement or compromise.

“Confidential Information” means information which, prior to or during the Term (including pursuant to the Earlier Confidentiality Agreement) is disclosed or shared by one Party to the other Party or generated or developed by one or both Parties, including information that was disclosed, shared, generated or developed under the Earlier Confidentiality Agreement, that the non-owning Party has a reasonable basis to believe is confidential to the owning Party or has been marked or orally designated by the owning Party as confidential.

“CPR” has the meaning ascribed thereto in Section 3(E)(ii).

“Cure Period” has the meaning ascribed thereto in Section 5(C)(i).

“Damages” has the meaning ascribed thereto in Section 11(A).

“Definitive Agreements” means this Agreement and the License Agreement, collectively.

“Determination Notice” means a notice from CPI to SVI stating that CPI has determined that a New Lead is (or is not) a Royalty Product or will become (or will not become) a Royalty Product upon the issuance of any allowed claims of any pending application for a Royalty Patent.

“Development IP” means, collectively, the BSC Solely Invented Development IP, the SVI Solely Invented Development IP and the Joint Development IP, in each case that is conceived or reduced to practice during the Term and, unless CPI terminates this Agreement pursuant to Section 5(B) or Section 5(C)(v), a period of two (2) years thereafter. For the avoidance of any doubt, in no event shall the Development IP include (i) the Royalty Patents, (ii) any Existing Intellectual Property, (iii) any Future Intellectual Property or Joint Intellectual Property conceived and reduced to practice prior to the Effective Date, or (iv) IPR in and to any Intellectual Property licensed by SVI pursuant to the JHU Agreements. The Parties agree and acknowledge that any Future Intellectual Property conceived or reduced to practice after the Effective Date may also constitute Development IP.

“Earlier Confidentiality Agreement” means that certain Mutual Nondisclosure Agreement entered into by the Parties on August 20, 2006, as amended by the First Amendment to the Mutual Nondisclosure Agreement entered into by the Parties on September 5, 2007.

“Effective Date” is defined in the introductory paragraph.

“Existing Intellectual Property” has the meaning ascribed thereto in Section 4.8 of the Bionics Lead Development Agreement.

“Feasibility Study” and “Feasibility Studies” have the meaning ascribed thereto in Section 2(A)(i).

“Field” means the Implantable Cardiac Field and the Neuro Field, collectively.

“Future Intellectual Property” has the meaning ascribed thereto in Section 7.6 of the Bionics Lead Development Agreement.

“Heart Failure Lead” has the meaning ascribed thereto in the Project Plan attached as Exhibit A.

“Indemnified Party” has the meaning ascribed thereto in Section 11(A).

“Indemnifying Party” has the meaning ascribed thereto in Section 11(A).

“Implantable Cardiac Field” means the field of implantable medical leads for all cardiac applications (including nerve stimulation for intentionally affecting the heart), including implantable leads for cardiac rhythm

“Infringe” means (as applicable, depending on the context of the subject or object of the word Infringe) to infringe, misappropriate, use or disclose without authorization or otherwise violate Intellectual Property Rights (whether direct, indirect, contributory, inducement or otherwise). The words “Infringement” and “Infringing” have corresponding meanings.

“Intellectual Property” means intangible property that is legally protectable, including inventions, improvements, discoveries, conceptions, algorithms, integrated circuits, ideas, techniques, processes, designs, products, developments, specifications, methods, drawings, diagrams, tooling, models, software programs (including object code, source code and commenting), data, data analysis, data interpretation, written reports, Know-How, Trade Secrets, Confidential Information, documentation and copyrightable material whether patentable or non-patentable.

“Intellectual Property Rights” or “IPRs” means all rights under or to Intellectual Property.

“JHU” means the Johns Hopkins University.

“JHU Agreements” means, collectively, (i) that certain License Agreement by and between SVI and JHU entered into on or around June 20, 1998, as amended by that certain Amendment to License Agreement dated as of January 15, 2000, and as further amended by that certain Addendum to License Agreement entered into on or around December 7, 2004, as in effect as of the Effective Date, (ii) that certain License Agreement by and between SVI and JHU entered into on or around December 7, 2006, as in effect as of the Effective Date; (iii) the consent letter dated December 27, 2005 signed by JHU, (iv) the consent letter dated August 7, 2007 signed by JHU, (v) the letter dated August 7, 2007 signed by Bionics, SVI and JHU, and (vi) the consent letter dated March 19, 2008 signed by SVI and JHU.

“Joint Development IP” means any Intellectual Property Rights, other than Royalty Patents, conceived or reduced to practice jointly by SVI (or its Affiliates, employees, agents or consultants) and CPI or one of its Affiliates (or their respective employees, agents or consultants) that are (i) related to this Agreement, (ii) primarily related to the Field, or (iii) based on CPI’s or its Affiliates’ Confidential Information.

“Joint Intellectual Property” has the meaning ascribed thereto in Section 11.1(b) of the Bionics Lead Development Agreement.

“Key Employees” means (i) [***] and (ii) each other employee, agent, consultant and contractor of SVI who has contributed to or participated in the conception, creation, development or reduction to practice of any Development IP or Royalty Patent on behalf of SVI provided such Person is an employee, agent, consultant or contractor of SVI on or after the Effective Date.

“Know-How” means all factual knowledge and information that gives a Person the ability to produce or market something that it otherwise would not have known how to produce or market with the same accuracy or precision, including all formulae, algorithms, processes, procedures, writings, data, protocols, techniques, proposals, designs, ideas, concepts, strategic, research and development information and related documentation business and other plans, research, inventions, and invention disclosure and all records of the foregoing.

“Licensed Product” means any product in the Implantable Cardiac Field, including but not limited to Royalty Products.

“Milestone One” has the meaning ascribed thereto in Section 4(A).

“Milestone Payment” means the payment due by CPI to SVI upon satisfaction of any of the Milestones.

“Milestones” has the meaning ascribed thereto in Section 4.

“Milestone Three” has the meaning ascribed thereto in Section 4(C).

“Milestone Two” has the meaning ascribed thereto in Section 4(B).

“Neuro Field” means the neuromodulation field of the Bionics Lead Development Agreement. For purposes of clarity, the Neuro Field does not encompass the Implantable Cardiac Field.

“New Lead” means any implantable medical lead developed in connection with the Project Plan.

“Opinion” has the meaning ascribed thereto in Section 3(D).

“Patent” means all classes or types of patents, design patents, utility patents, including issued patents, published and non-published patent applications (including inventors’ certificates and utility models) in any country or jurisdiction or under any treaty, including all originals, provisionals, substitutions, continuations, continuations-in-part,

“Person” means an individual, partnership, corporation, business trust, limited liability company, unincorporated association, trust, joint venture or any other entity or governmental authority

“Project” means the research and development to be conducted according to this Agreement to develop implantable medical leads.

“Project Manager” has the meaning ascribed thereto in Section 2(B).

“Prosecution” means prosecution of any proceeding in the United States Patent and Trademark Office or in any other registration authority in any country, including regarding any application (whether ex parte or inter partes), including interference, reexamination and reissue.

“Prosecution Costs” has the meaning ascribed thereto in Section 6(A).

“Prosecution Request” has the meaning ascribed thereto in Section 6(D).

“Royalty Patent” means (i) a Patent to which SVI has and has granted to CPI exclusive commercial rights in the Implantable Cardiac Field and which is listed on Exhibit D to the License Agreement, (ii) any claims of any future Patent for which SVI has and has granted to CPI exclusive commercial rights in the Implantable Cardiac Field, which claim and are entitled to claim (in whole, but not in part) priority to a Patent covered by the preceding clause (i) (e.g., claims in a continuation-in-part Patent which require new matter for support are not Royalty Patents), and (iii) any of the Billabong Patents to which SVI has and has granted to CPI exclusive commercial rights in the Implantable Cardiac Field. For the avoidance of any doubt, CPI acknowledges and agrees that the following shall not be considered in determining whether SVI has and has granted to CPI exclusive commercial rights in the Implantable Cardiac Field with respect to any Patent: (a) any lien or security interest in such Patent; (b) any rights retained by JHU under the JHU Agreements; (c) to the extent the Patent was supported by federal funding obtained by JHU, any rights, conditions and limitations imposed by U.S. law (including any royalty-free nonexclusive license granted to the U.S. government pursuant to U.S. law and any requirement that products used or sold in the U.S. be manufactured substantially in the U.S.); and (d) any right to author, to publish and to retain or transfer copyright to scientific reports retained by SVI or SVI’s collaborators or granted by SVI to Third Parties.

“Royalty Product” means an implantable lead (alone or in combination with other devices) that if sold by CPI or one of its Affiliates in the

Implantable Cardiac Field would (absent the License (as defined in the License Agreement)) Infringe a valid and enforceable claim of an issued Royalty Patent.

“Royalty Product Dispute” has the meaning ascribed thereto in Section 3.

“Short Form Registration Statement” means a short-form document suitable for recordation at a local patent office, sufficient to put persons on notice of the license to Patent rights granted pursuant to the Definitive Agreements.

“Surgi-Vision IP” means all IPR in and to all Intellectual Property in the Implantable Cardiac Field now or hereinafter owned by or exclusively licensed to SVI, including the Billabong Patents.

“SVI Grant-Back Field” means all uses which are simultaneously outside both the (i) field of implantable medical devices, and (ii) the Field.

“SVI Solely Invented Development IP” means any Intellectual Property Rights, other than Royalty Patents, conceived or reduced to practice solely by SVI (or its Affiliates, employees, agents or consultants) that are (i) related to this Agreement, (ii) primarily related to the Field, or (iii) based on CPI’s or its Affiliates’ Confidential Information; provided, however, that in no event shall SVI Solely Invented Development IP include any Intellectual Property Rights conceived or reduced to practice by SVI (or its Affiliates, employees, agents or consultants) that relate to the System (as defined in the Bionics Lead Development Agreement), but which do not in any way relate to the Lead (as defined in the Bionics Lead Development Agreement), for which Bionics has not contributed to the conception or design.

“Tachy Lead” has the meaning ascribed thereto in the Project Plan attached as Exhibit A.

“Technology Transfer” means SVI’s transfer to CPI of all relevant information relating to the use of technology in the Implantable Cardiac Field, including (i) all information relating to such technology, including research documentation, designs, design drawings, specification, Know-How and test methodology and data for the technology, (ii) all manufacturing information and Know-How, including manufacturing process details, identification of manufacturing equipment, and descriptions of associated quality control tests, and (iii) training of CPI and CPI Affiliate personnel on product design and manufacturing.

“Term” has the meaning ascribed thereto in Section 5(A).

“Termination Option” has the meaning ascribed thereto in Section 5(B).

“Third Party” and “Third Parties” mean one or more Persons other than SVI, CPI and their respective Affiliates.

“Third Party Licensor” means any Third Party that has granted a Party a license to Intellectual Property.

“Trade Secret” means any Know-How or other information that generally facilitates the production, manufacturing, marketing, or sale of products or services, increases revenues, or provides an advantage over the competition, is not generally known, and is the subject of reasonable efforts to maintain its confidentiality.

Development.

Feasibility and Development.

Project Administration. Each of SVI and CPI will appoint a project manager to act on its behalf for the Project (each, a “Project Manager”) and each Party may replace its Project Manager at any time upon notice to the other Party. SVI’s initial Project Manager will be [***]. CPI’s initial Project Manager will be [***]. The Project Managers will act as contact persons between the Parties in conducting the Project, and will meet on an as-needed basis as mutually agreed to monitor and discuss the Project’s progress. The Project Manager meetings may take place in person or via telephonic or other electronic means of communication as the Parties may agree.

Amending Project Plan. CPI may, upon reasonable notice to SVI in writing, request reasonable changes to the Project Plan by notifying SVI of the requested change, including such detail as will allow SVI to evaluate it (a “Change Request”). Within ten (10) business days after SVI’s receipt of a Change Request, SVI will, at its own expense, deliver a document to CPI that (i) assesses whether and the extent to which the requested change causes an increase or decrease in the costs or time required to perform the Project, and (ii) incorporates a description of the requested changes (a “Change Control Document”). If CPI accepts the Change Control Document in writing, then the provisions of this Agreement and the Project Plan shall be deemed amended to incorporate such change in accordance with the Change Control Document. If CPI does not accept the Change Control Document in writing within ten (10) business days after CPI’s receipt of the Change Control Document, CPI shall be deemed to have rejected the Change Control Document. Absent CPI’s acceptance of the Change Control Document in writing, no change requested by CPI pursuant to the Change Request shall be binding on either SVI or CPI.

FDA Approval. SVI will assist CPI, at CPI’s sole expense, in obtaining applicable regulatory and legal approvals for any New Lead developed under this Agreement or any product in which a New Lead is used, to the extent reasonably requested by CPI. Without limiting the foregoing, if CPI chooses to conduct one or more clinical trials relating to a New Lead or any product in which a New Lead is used, SVI will provide commercially reasonable cooperation and assistance to CPI, at CPI’s sole expense, in developing protocols relating to the trial and in conducting the trial, if requested by CPI.

Within sixty (60) days after (i) successful completion of a Feasibility Study with respect to a New Lead, (ii) successful completion of the Technology Transfer relevant to a New Lead, and (iii) receipt of FDA approval for a New Lead, CPI shall deliver to SVI a Determination Notice regarding such New Lead. Notwithstanding the foregoing, any failure by CPI to deliver a Determination Notice will not constitute a breach of this Agreement (it being understood, however, that any failure by CPI to deliver a timely Determination Notice could result in SVI having additional time to assert that the New Lead is a Royalty Product in accordance with the procedures of this Section 3 with respect to the applicable Milestone Payment).

Within ninety (90) days of SVI’s Chief Executive Officer, President or Chief Financial Officer obtaining actual knowledge of (i) successful completion of a Feasibility Study with respect to a New Lead, (ii) successful completion of the Technology Transfer relevant to a New Lead, or (iii) receipt of FDA approval for a New Lead, in each case where CPI has not already delivered a Determination Notice to SVI, SVI shall deliver to CPI written notice requesting that CPI deliver a Determination Notice for such New Lead with respect to the applicable Milestone Payment. Within sixty (60) days following CPI’s receipt of such a request, CPI shall deliver to SVI a Determination Notice regarding such New Lead. Notwithstanding the foregoing, (i) any failure by SVI to deliver a request for Determination Notice will not constitute a breach of this Agreement (it being understood, however, that any failure by SVI to deliver a timely request for Determination Notice could result in SVI losing the opportunity to claim that a New Lead constitutes a Royalty Product for purposes of the applicable Milestone Payment), and (ii) to the extent CPI determines that the New Lead is or will become a Royalty Product, SVI need not request any further Determination Notice(s) from CPI with respect to the same New Lead.

To the extent there is any dispute between the Parties as to whether a New Lead constitutes (or will constitute) a Royalty Product (any such dispute being referred to herein as a “Royalty Product Dispute”), such Royalty Product Dispute shall be exclusively resolved pursuant to the provisions of this Section 3. SVI may deliver to CPI written notice of its intent to begin a Royalty Product Dispute within, and only within, the following timeframes. For the purposes of clarity, if SVI fails to deliver to CPI written notice of a Royalty Product Dispute within the following timeframes, SVI waives its rights to challenge CPI’s determination or to otherwise claim that a New Lead constitutes (or will constitute) a Royalty Product for purposes of the applicable Milestone Payment.

In the event the Parties are unable to resolve a Royalty Product Dispute informally within forty-five (45) days after delivery of SVI’s written notice of such Royalty Product Dispute, the Parties shall hire an experienced patent attorney who is knowledgeable in the field of intellectual property law relating to medical devices and who (and whose firm) shall have no current or prior (within the preceding five year period) business relationships with the Parties or any of their respective Affiliates to offer an opinion, within a reasonable amount of time as mutually agreed upon by the Parties, as to whether the New Lead subject to the Royalty Product Dispute constitutes a Royalty Product (the “Opinion”). If either Party challenges the Opinion, resolution of the Royalty Product Dispute will proceed as follows under this Section 3. The cost of such patent attorney shall be shared equally between the Parties.

No Party hereto may invoke, demand, file or otherwise commence an arbitration pursuant to Section 3(F) until the Parties have completed a good faith mediation of the applicable Royalty Product Dispute in accordance with the following provisions:

In the event that no agreement is reached by CPI and SVI as to a Royalty Product Dispute following a good faith mediation in accordance with Section 3(E) above, either CPI or SVI, acting alone, may deliver to the other Party written notice demanding arbitration within twenty (20) days following the completion of such mediation undertaken, in which case the following provisions shall apply:

Milestone One Payment. Within forty-five (45) days after successful completion of the Feasibility Study for a New Lead described in the Project Plan pursuant to Section 2(A)(i) above (“Milestone One”), CPI will pay to SVI the following amounts: Acceptance of the Brady Lead Feasibility Study - five hundred thousand ($500,000.00) dollars; Acceptance of the Heart Failure Lead Feasibility Study - four million ($4,000,000.00) dollars; Acceptance of the Tachy Lead Feasibility Study - four million ($4,000,000.00) dollars.

Milestone Two Payment. If Milestone One has been achieved with respect to at least one of the Feasibility Studies, and CPI does not exercise the Termination Option in Section 5(B) below, within forty-five (45) days after successful completion of the first Technology Transfer relevant to a New Lead pursuant to Section 2(A)(iii) above (“Milestone Two”), CPI will pay SVI five hundred thousand ($500,000.00) dollars. For purposes of clarity, there is only a single Milestone Two payment, even if there is Technology Transfer for all three (3) lead types.

Milestone Three Payment. If Milestone Two has been achieved, within forty-five (45) days after receipt of FDA approval, if any, for a New Lead described in the Project Plan (“Milestone Three”), CPI will pay SVI the following amounts: Brady Lead FDA approval - one million ($1,000,000.00) dollars; Heart Failure Lead FDA approval - five million ($5,000,000.00) dollars; Tachy Lead FDA approval - five million ($5,000,000.00) dollars. For purposes of clarity, there is only a single Milestone Three payment for each lead type, regardless of FDA approval for multiple lead designs of a single lead type.

Subject to Section 6(B) of the License Agreement, on and after the date hereof, CPI shall have full control, authority and discretion over any and all commercialization of Royalty Products, including: (i) all activities relating to clinical trials for Royalty Products, including commencement, termination, patient enrollment, design and timing, (ii) all activities relating to the manufacture and supply of the Royalty Products; (iii) all marketing, promotion, sales, distribution, import and export activities relating to the Royalty Products; and (iv) all activities relating to any regulatory filings, registrations, applications and approvals relating to any of the foregoing. As between the Parties, CPI shall own all data, results and all other information arising from any such activities under this Agreement, including all regulatory filings, registrations, applications and approvals relating to Royalty Products, and all of the foregoing information, documentation and materials shall be considered Confidential Information owned solely by CPI. Other than funding for the activities required to be performed by SVI, as specifically identified in the Project Plan, as between the Parties the funding of these activities will be by CPI. It is hereby acknowledged and agreed that notwithstanding any and all

After the completion of Milestone One, SVI will remain, and will use its commercially reasonable efforts to cause its employees and contractors to remain, available for consulting related to the technology and its use in the Implantable Cardiac Field, at commercially reasonable mutually agreed upon terms.

Term and Termination.

Term.     Unless sooner terminated pursuant to this Section 5, the term of this Agreement will begin as of the Effective Date and shall remain in full force and effect until, and shall expire upon, FDA approval of a lead design for each of the three (3) lead types described in the Project Plan (“Term”).

Termination Option by CPI.     CPI may, in its sole discretion, elect not to continue with further development and terminate this Agreement upon written notice to SVI within sixty (60) days after successful completion of the first Feasibility Study pursuant to Section 2(A)(i) above (the “Termination Option”).

Termination for Cause.

Effect of Termination. Upon expiration of this Agreement or termination of this Agreement by either Party, (i) each Party will comply with Section 9(E) (“Return of Information”), and (ii) SVI will effect a Technology Transfer of all Development IP in whatever form or stage of completion the subject of such Technology Transfer may be in at the time of such expiration or termination.

Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Without limiting the foregoing, the obligations pursuant to Sections 1, 4(A), 4(B), 4(C) (it is understood, however, that Sections 4(A), 4(B) and 4(C) will survive without prejudice to any right that CPI may have to damages or offset), 5(D), 5(E), 6, 7, 8, 9, 10, 11, 13, 15 and 16 shall survive termination of this Agreement. Notwithstanding the foregoing, no claim for breach of warranty or representation under Section 10 may be brought unless it is either (i) brought no later than two years following the latter of the termination or expiration of this Agreement or the License Agreement, or (ii) brought anytime as a counterclaim or a defense.

Intellectual Property Ownership; Licenses.

Ownership.

Assignment. SVI hereby assigns and transfers, and shall cause its employees and consultants to assign and transfer, to CPI (or, to the extent

Further Assurances. Each Party agrees to (and to cause its Affiliates, and its and their employees, agents and consultants to) promptly and fully disclose in writing to the other Party all Development IP, including all invention disclosure forms or other internal documents as such Party utilizes in the ordinary course of its business to document new inventions. SVI agrees to (and to cause its Affiliates, and its and their employees, agents and consultants to): (i) execute all documents necessary to effect its assignment of such Development IP, (ii) assist CPI and its Affiliates as set forth in Section 7, at CPI’s or such Affiliates’ expense, in obtaining foreign and domestic intellectual-property protection on all Development IP and enforcing same, (iii) execute all documents necessary to obtain such intellectual-property protection in the name of CPI and its Affiliates, and (iv) maintain all information relative to all Development IP, as Confidential Information of CPI and its Affiliates subject to the confidentiality provisions (including permitted disclosures) set forth in this Agreement.

SVI Licenses. CPI hereby grants SVI (i) an exclusive, fully paid, sublicensable, worldwide, perpetual license to all Development IP that is SVI Solely Invented Development IP for use within the SVI Grant-Back Field, and (ii) a non-exclusive, fully paid, sublicensable, worldwide, perpetual license to all Development IP (with the exception of the Bionics Reserved IP) that is BSC Solely Invented Development IP or Joint Development IP, for use within the SVI Grant-Back Field. CPI agrees to (and to cause its Affiliates to) execute confirmatory licenses reasonably requested by SVI to evidence SVI’s rights herein set forth.

CPI License. SVI hereby grants CPI an exclusive, fully paid, sublicensable, worldwide license in the Field for any Surgi-Vision IP developed or acquired during the Term and a period of two (2) years thereafter, that is not already owned, assigned or licensed to CPI or its Affiliates, provided, that (i) the foregoing license shall terminate in the event CPI exercises the Termination Option, and (ii) in no event shall the foregoing license include any Intellectual Property Rights conceived or reduced to practice by SVI (or its Affiliates, employees, agents or consultants) that relate to the System (as defined in the Bionics Lead Development Agreement), but which do not in any way relate to the Lead (as defined in the Bionics Lead Development Agreement), for which Bionics has not contributed to the conception or design. Subject to the foregoing, the Parties acknowledge that this license is intended to capture Surgi-Vision IP developed or acquired in the time frame described hereinabove which, although related to the Field, is not “primarily” related to the Field. For the avoidance of any doubt, in no event (x) does this

Joint Development Agreement. This Development Agreement is and is intended to be a “joint development agreement” within the meaning of 35 U.S.C. § 103(c).

Patent Prosecution.

Costs.     CPI and its Affiliates will pay all Patent Prosecution costs and expenses for all Patents subject to their sole control, as set forth in Section 7(B) below (“Prosecution Costs”).

Intellectual Property Protection.   With respect to any BSC Controlled IP, CPI and its Affiliates will jointly control the Prosecution of all Patents, each at its own expense and with legal counsel of its own choice, and will take such other legal steps as CPI and its Affiliates will determine in their sole discretion to be necessary to protect their rights for all BSC Controlled IP. For the avoidance of doubt, neither CPI nor its Affiliates will be obligated to pay any Prosecution Costs to protect any Intellectual Property if they determine, in their sole discretion, that those Prosecution Costs outweigh the likely benefits to CPI or such Affiliate.

SVI Cooperation.   SVI will cooperate with CPI and its Affiliates in filing, Prosecuting and maintaining Patents and taking such other legal steps as set forth in this Section 7 and will execute and deliver any documents and instruments in connection therewith which CPI or its Affiliates may request at no additional cost or expense to CPI or such Affiliate.

SVI Intervention.   CPI (or its applicable Affiliate) will provide written notice to SVI prior to abandoning any patent application or issued Patent that is part of the BSC Controlled IP. If SVI desires to file and Prosecute any patent application, or to pay maintenance fees or annuities to maintain any issued Patent, that CPI or its Affiliates determined was not worthwhile to protect CPI’s or such Affiliates’ rights, SVI may provide CPI with a reasonable written request to file and Prosecute or maintain such Patent (“Prosecution Request”). If CPI fails to complete the Prosecution Request after thirty (30) days of receiving the Prosecution Request, then as between the Parties: (i) SVI may independently file and Prosecute the patent application or maintain the issued Patent that was the subject of the

Prosecution Request; (ii) SVI will bear all Prosecution Costs with respect to such patent application or issued Patent; (iii) SVI will control the remainder of the Prosecution for the patent application or the maintenance of the issued Patent that was the subject of the Prosecution Request; and (iv) CPI and its Affiliates will have the right (but not the obligation) to participate in an advisory capacity in such Prosecution. The Parties acknowledge and agree that any action by SVI pursuant to this Section 7(D) will not confer or convey any ownership rights in the subject Patent to SVI, and will not otherwise adversely affect any of CPI’s or its Affiliates’ rights in same.

Enforcement.

Notice of Infringement. If either Party learns of any actual, alleged or threatened Infringement of any BSC Controlled IP by a Third Party, such Party shall promptly notify the other Party and shall provide such other Party with all available evidence of such Infringement.

Enforcement [***]. As between the Parties, [***] shall have the sole right (but not the obligation), each at its own expense and with legal counsel of its own choice, to bring suit (or take other appropriate legal action) against any actual, alleged or threatened Infringement of [***] provided, however, that [***] shall have the right (but, subject to Section 11(C) below, not the obligation) to participate in an advisory capacity only in the institution and prosecution of any such Infringement suit, [***].

Join in Action. If either [***] brings any such action or proceeding hereunder, [***] agrees to be joined as party plaintiff if necessary to prosecute such action or proceeding, and, at [***] expense, to give [***] reasonable assistance and authority to file and prosecute the suit; provided, however, that neither [***] shall be required to transfer any right, title or interest in or to any property to [***] or any Third Party to confer standing on [***] hereunder.

Costs. [***] will pay all costs, fees, and expenses associated with an Infringement action they have initiated and prosecuted. [***] will pay all costs, fees, and expenses associated with [***] participation in an advisory capacity under Section 8(B).

Recovery. Any recovery obtained in an action initiated and prosecuted solely by [***], and in which [***] does not participate in an advisory capacity, shall belong to [***]. Any recovery obtained in an action initiated and prosecuted by [***], and in which [***] participates in an advisory capacity, shall be

Cooperation. [***] agrees to fully cooperate with [***] in the prosecution of any such suit at no additional expense to [***].

Confidentiality.

Ownership of Confidential Information. The Parties agree that (i) all BSC Controlled IP will be deemed to be Confidential Information owned by CPI (irrespective of which Party generated, development or first shared or disclosed such information), (ii) all BSC Core Product Information generated or developed by CPI, its Affiliates, or a Third Party on behalf of CPI or its Affiliates will be deemed to be Confidential Information owned by CPI, and (iii) the terms and existence of the Definitive Agreements are Confidential Information owned by both Parties. Except as otherwise expressly provided in this Section 9, neither Party is subject to the obligations of a “non-owning Party” with respect to Confidential Information that is owned by both Parties. Except as otherwise expressly provided in this Agreement, for all other Confidential Information, the “owning Party” is deemed to be the disclosing Party. Confidential Information shall remain the property of the owning Party, and the non-owning Party shall not be deemed by virtue of this Agreement or any access to the owning Party’s Confidential Information to have acquired any right, title or interest in or to any Confidential Information, except the limited right to use such Confidential Information in accordance with the terms of the Definitive Agreements or other agreements between the Parties or their Affiliates.

Non-Use and Non-Disclosure. Prior to the commencement of the Term, certain Confidential Information was exchanged between the Parties under the terms of the Earlier Confidentiality Agreement. Likewise, from time to time during the Term, either Party may make available to the other Party or otherwise generate or develop Confidential Information. The non-owning Party will maintain the owning Party’s Confidential Information in confidence and will not use such Confidential Information except as reasonably necessary to perform its obligations and exercise its rights under this Agreement or other agreements between the Parties or their Affiliates. Notwithstanding any provision to the contrary contained in the Bionics Lead Development Agreement, SVI agrees and acknowledges that CPI and its Affiliates may share all of SVI’s Confidential Information with and among each of their respective Affiliates for use solely within the Field, provided that (i) prior to any such sharing of SVI’s Confidential Information such Affiliates are bound by obligations of confidentiality, non-disclosure and non-use substantially similar in scope to those in this Agreement and (ii) CPI shall be

Standard Exceptions. The obligations of Sections 9(B), (E) and (F) do not apply to any of the other Party’s Confidential Information: (i) which, other than the Development IP, is already known by the non-owning Party at the time of the disclosure; (ii) following such information becoming publicly known without the wrongful act or breach of this Agreement by the non-owning Party; (iii) following such information becoming rightfully received by the non-owning Party from a Third Party without breaching any confidentiality obligation owed by such Third Party to the owning Party; (iv) following such information becoming approved for release by written authorization of the owning Party; or (v) other than the Development IP, following such information becoming subsequently and independently developed by employees or representatives of the non-owning Party without knowledge or use of the owning Party’s Confidential Information. The burden of proving the existence of facts which would provide an exception under this Section 9(C) rests with the non-owning Party. Notwithstanding any provision herein to the contrary, to the extent required under the JHU Agreements, SVI shall be permitted to disclose the terms of this Agreement to JHU.

Permitted Disclosures. Each Party may disclose the other Party’s Confidential Information:

Return of Information. Upon termination or expiration of this Agreement for any reason, each Party will return or destroy (at the other Party’s choice) all Confidential Information owned by such other Party then in its possession and, if applicable, provide a certification of such destruction.

Injunctive Relief. Each Party acknowledges and agrees that the breach of this Section 9 would be likely to cause serious and irreparable harm, the amount of which may be extremely difficult to estimate, thus making any remedy at law or in damages inadequate. Each Party therefore agrees that if the other Party breaches this Section 9 or if such Party has cause to

Termination of Earlier Confidentiality Agreement. The Parties agree that the Earlier Confidentiality Agreement will terminate as of the Effective Date, and that any and all Confidential Information exchanged or disclosed by the Parties pursuant to the Earlier Confidentiality Agreement will be subject solely to the terms of this Section 9 and Section 9 of the License Agreement.

Representations, Warranties and Covenants.

No Conflicting Agreements.    SVI represents, warrants and covenants that, after giving effect to the Bionics Amendment, it has not and will not enter into any agreement or commitment or obligation with any Third Party or Affiliate that conflicts in any way with its obligations under this Agreement. CPI represents, warrants and covenants that it has not and will not enter into any agreement or commitment or obligation with any Third Party or Affiliate that conflicts in any way with its obligations under this Agreement.

Authority.    Each Party represents and warrants that, as of the Effective Date and after giving effect to the Bionics Amendment: (i) it has the full right, power, and authority to execute and deliver this Agreement and to perform its terms; (ii) it has taken all required corporate actions to approve and adopt this Agreement; (iii) this Agreement is enforceable against it according to its terms, subject to bankruptcy, insolvency, and other laws relating to or affecting creditors’ rights and to general equity principles; and (iv) the person or persons executing this Agreement on its behalf are duly authorized and empowered to do so.

Sufficiency.    SVI represents and warrants that Exhibit A and Exhibit D to the License Agreement collectively set forth a true and complete list, as of the Effective Date, of all Patents related to the development of the Licensed Products pursuant to the Development Agreement which are (i) owned or co-owned by SVI, and (ii) licensed to SVI (complete with the name of the Third Party Licensor of each licensed Patent) in the Implantable Cardiac Field. SVI represents and warrants that all items required to be disclosed pursuant to clause (ii) are licensed exclusively to SVI and constitute Surgi-Vision IP

Personnel.

Non-Infringement. SVI represents and warrants as of the Effective Date that, to its actual knowledge, the New Leads will not Infringe any Patents, Trade Secrets, copyrights or other Intellectual Property Rights of any Third Party or Affiliate. If, at any time, SVI becomes aware or has reason to believe that the New Leads may Infringe any Patents, Trade Secrets, copyrights or other Intellectual Property Rights of any Third Party or Affiliate, SVI shall promptly notify CPI in writing of such awareness or belief, describing in reasonable detail the basis for same.

Freedom to Operate. SVI represents and warrants that, as of the Effective Date, it has not received and has no knowledge of any Claim by a Third Party containing any express or implied allegation that SVI, its Third Party Licensors or the Surgi-Vision IP is or may be Infringing any of such Third Party’s Intellectual Property Rights, except that (a) SVI knows of a Third Party’s attempt to invoke an interference against U.S. 6,904,307, (b) SVI has filed a re-issue with respect to U.S. 6,904,307, and (c) SVI has filed a patent application (application number [***]) attempting to [***]. If, at any time during the Term, SVI receives or becomes aware of any such Claim, SVI shall promptly notify CPI of such Claim in writing, describing the Claim in reasonable detail (but performing and providing no written analysis regarding the Claim). Provided CPI has not exercised its Termination Option, upon such notice, CPI may, in its sole discretion, evaluate such Claim to determine whether a license of the Third Party’s Intellectual Property is necessary or desirable, or whether such Third Party’s Intellectual Property may otherwise have a material effect on the Surgi-Vision IP in the Implantable Cardiac Field.

Know-How and Trade Secrets. SVI represents, warrants and covenants that: (i) it has taken, and will continue to take, all actions that a reasonably prudent person would take to maintain its Trade Secrets as confidential and proprietary, and to protect against the loss, theft or unauthorized use of such Trade Secrets; (ii) its Trade Secrets are not in the public domain and have not been divulged or appropriated to the detriment of SVI; and (iii) SVI’s records do and will continue to include sufficient documentation of the Know-How and Trade Secrets, such as manufacturing and engineering plans, blueprints, designs, process instructions, formulae, quality assurance protocols and procedures and the like, to enable persons who are reasonably skilled and proficient in the relevant subject matter to continue the same in the ordinary course of business without unreasonable delay, expense, or reliance on the memory of any individual.

Disclosure. SVI represents and warrants that in the course of diligence and negotiations leading up to the execution of this Agreement, SVI has not misrepresented to CPI any material information regarding the Surgi-Vision IP, the technology related thereto, the to-be-developed Development IP and the New Leads.

Indemnification.

General Indemnification.    Each Party (the “Indemnifying Party”) will defend, indemnify and hold harmless the other Party (the “Indemnified Party”) and all of such Party’s Affiliates from and against any and all liabilities, losses, obligations, claims, damages, penalties, causes of action, costs and expenses (including attorneys’ fees) (collectively “Damages”), to the extent such Damages arise out of any Third Party claim based on allegations that, if true as alleged, would constitute (i) a breach of the representations and warranties made by it in this Agreement, or (ii) a material breach of its obligations pursuant to this Agreement.

Indemnification Procedures.    An Indemnifying Party’s duty to indemnify pursuant to Section 13(A) is subject to the Indemnified Party giving prompt written notice to such Indemnifying Party of any claim against the Indemnified Party covered by the Indemnifying Party’s indemnification obligations hereunder; provided, however, that a delay in such notice to the Indemnifying Party shall not terminate indemnification obligations hereunder, unless such delay shall have materially impaired the defense of such claim. The Indemnifying Party shall have sole and exclusive control of the defense of any such claim, including the choice and direction of any legal counsel. The Indemnified Party may not settle or compromise any such claim without the written consent of the Indemnifying Party.

Insurance. Each Party shall procure and maintain the following insurance during the term of this Agreement:

Commercial General Liability Insurance. The insurance shall provide coverage against all claims arising from or relating to the Definitive Agreements in any manner including, but not limited to, product liability claims and those claims which allege bodily injuries and/or property damage. The liability limits shall not be less than $1,000,000 per occurrence and $1,000,000 in the aggregate for such claims.

Excess Liability Insurance. The insurance shall provide excess liability coverage against the risks specified in subsection A above. The liability limits shall not be less than $1,000,000 per occurrence.

Notices. Any notice or other communication in connection with this Agreement must be in writing, must be addressed as provided below and will be deemed delivered when (a) actually delivered in person or by facsimile, provided that delivery is made during normal business hours, (b) three business days have elapsed after deposit in the United States mail, postage prepaid and registered or certified, return receipt requested, or (c) two business days after sent by nationally recognized overnight receipted courier:

To CPI:

Cardiac Pacemakers, Inc. c/o

Boston Scientific Corporation

One Boston Scientific Place

Natick, MA 01760-1537

Attention: Chief Financial Officer

Phone: 508.650.8000

Fax: 508.650.8956

with copies to:

Boston Scientific Corporation

One Boston Scientific Place

Natick, MA 01760-1537

Attention: General Counsel

Phone: 508.650.8000

Fax: 508.650.8960

and

Cardiac Pacemakers, Inc.

4100 Hamline Avenue North

St. Paul, MN 55112

Attention: Chief Patent Counsel

Phone: 651.582.7196

Fax: 651.582.2926

To SVI:

Kimble L. Jenkins

Surgi-Vision, Inc.

50 North Front Street

19th Floor

Memphis, TN 38103

Phone: 901.531.3236

Fax: 901.579.4979

with copies to:

John C. Thomas, Jr.

Surgi-Vision, Inc.

200 N. Cobb Parkway

Suite 140

Marietta, GA 30062-3585

Phone: 770.514.0077

Fax: 770.424.8236

and

Oscar L. Thomas

Bass, Berry & Sims PLC

100 Peabody Place

Suite 900

Memphis, TN 38103

Phone: 901.543.5905

Fax: 901.543.5999

Assignment.    This Agreement shall be binding upon and inure to the benefit of the Parties and their successors and permitted assigns. Neither this Agreement nor any right or obligation hereunder will be assignable by a Party without the prior written consent of the other Party and any purported assignment without such consent will be void; provided that, subject to CPI’s exercise of its rights pursuant to Section 5(C)(iv), either Party may, without such prior written consent, assign this Agreement to an Affiliate or in connection with a merger or consolidation (or other similar transaction) or the sale of all or substantially all of its assets in the realm of its respective field under this Agreement; provided, further, that such Party must give the other Party thirty (30) days prior written notice of such assignment. Any permitted assignee will assume all obligations of its assignor under this Agreement. No assignment will relieve any Party of responsibility for the performance of any accrued obligation that such Party then has hereunder.

Affiliates.    To the extent that CPI allows its Affiliates to exercise rights pursuant to this Agreement (including under a sublicense from CPI), CPI agrees (i) to bind such Affiliates to the confidentiality, use restriction, records/audit, intellectual property enforcement and patent Prosecution provisions of this Agreement and (ii) to be responsible for any breaches by its Affiliates of such provisions. Notwithstanding anything to the contrary, but subject to the previous sentence, if and when CPI allows its Affiliates to exercise rights pursuant to this Agreement (including under a sublicense from CPI), CPI may do so under any form of permission or arrangement, whether written, oral or course of conduct, and if done pursuant to a written document irrespective of whether that particular written document contains within its four corners all of the restrictions and requirements set forth in this Agreement.

Force Majeure.    If the performance of this Agreement or any obligations under this Agreement, except the making of required payments, is

prevented, restricted, or interfered with by reason of fire, flood, earthquakes, explosion, or other casualty, accident, or act of God; strikes or labor disturbances; war, whether declared or not, or other violence; sabotage; any law, order, proclamation, regulation, ordinance, demand, or requirement of any government agency; or any other event beyond the reasonable control of the Parties, the affected Party, upon giving prompt notice to the other Party, will be excused from such performance to the extent of such prevention, restriction, or interference. The affected Party will use its reasonable efforts to avoid or remove such cause of non-performance or to limit the impact of the event on such Party’s performance and will continue performance with the utmost dispatch whenever such causes are removed.

Export Controls.    A recipient of technical data or products agrees to comply with all United States Department of Commerce and other United States export controls. Each Party agrees that, unless prior authorization is obtained from the Office of Export Administration, it will not knowingly ship or transfer technical data covered by this Agreement or any direct product of such technical data, directly or indirectly, to any country in contravention of any Office of Export Administration requirement.

Entire Agreement.    This Agreement and its Exhibits, together with the License Agreement, set forth the entire agreement between the Parties and supersede all previous agreements and understandings, whether oral or written, between the Parties with respect to the subject matter of this Agreement.

Amendment.    This Agreement may not be modified, amended or discharged except as expressly stated in this Agreement or by a written agreement signed in ink by an authorized representative of each Party.

Separability. The provisions of this Agreement will be deemed separable. If any provision in this Agreement will be found or be held to be invalid or unenforceable in any jurisdiction in which this Agreement is performed, then the meaning of that provision will be construed, to the extent feasible, to render the provision enforceable, and if no feasible interpretation would save such provision, it will be severed from the remainder of this Agreement that will remain in full force and effect unless the provisions that are invalid or unenforceable substantially impair the value of the entire Agreement to either Party. In such event, the Parties will use their respective reasonable efforts to negotiate a substitute, valid and enforceable provision that most nearly reflects the Parties’ intent in entering into this Agreement.

Waiver. No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances will be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement.

Relationship of Parties. Each of the Parties hereto is an independent contractor and nothing herein will be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between the Parties hereto.

Counsel/Interpretation. The Parties and their respective counsel have negotiated this Agreement or have had an opportunity to review this Agreement. The Parties hereto acknowledge and agree that: (a) the rule of construction to the effect that any ambiguities are resolved against the drafting Party will not be employed in the interpretation of this Agreement; and (b) the terms and provisions of this Agreement will be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement. When used in this Agreement, the words “including” or “includes” are deemed to be followed by the words “without limitation.”

Governing Law. The construction, validity and performance of this Agreement will be governed exclusively by the laws of the State of Minnesota, U.S.A., without regard to the principles of conflicts of law. Each Party hereby submits itself for the sole purpose of this Agreement and any controversy arising hereunder to the non-exclusive jurisdiction of the federal and state courts located in the State of Minnesota, and any courts of appeal therefrom, and waives any objection (on the grounds of lack of jurisdiction, venue or forum non conveniens or otherwise) to the exercise of such non-exclusive jurisdiction over it by any such courts. With the exception of an arbitration pursuant to Section 3 above, any action brought by SVI against CPI in connection with this Agreement, must be instituted in the federal or state courts located in the State of Minnesota. A Party shall be entitled to seek within such jurisdiction whatever equitable relief it may be entitled to under applicable law.

Headings. The article and section headings in this Agreement are inserted for convenience only and will not constitute a part hereof.

No Third-Party Beneficiary Rights. Except with respect to CPI’s Affiliates and to Persons receiving indemnification under Section 11, no person not a Party to this Agreement is an intended beneficiary of this Agreement, and no person not a Party to this Agreement will have any right to enforce any term of this Agreement.

Compliance with Laws. Each Party will comply in all material respects with all applicable U.S. and foreign statutes, laws, ordinances, rules, orders and regulations in all actions relating to this Agreement and its performance hereunder.

Counterparts. This Agreement may be executed in any number of counterparts each of which will be deemed to be an original but all of which together will constitute one and the same instrument, and all signatures need not appear on any one counterpart.

Effect of Bankruptcy. No proceeding, or result or adjudication of a proceeding, in which either of the Parties is a debtor, defendant or party seeking an order for its own relief or reorganization, under any foreign, United States or state bankruptcy or insolvency law will (in and of itself) cause a termination of this Agreement or any of the licenses granted under this Agreement.

U.S. Dollars. All Milestone Payments to SVI contemplated in this Agreement shall be made in U.S. Dollars.

SURGI-VISION, INC.

CARDIAC PACEMAKERS, INC.

BY:

/s/ Kim Jenkins

BY

/s/ Fred Colen

NAME:

Kim Jenkins

NAME:

Fred A. Colen

TITLE:

Pres

TITLE:

Executive Vice President,

Operations and Technology CRM

ACKNOWLEDGEMENT BY BIONICS

Boston Scientific Neuromodulation Corporation (formerly known as Advanced Bionics Corporation) acknowledges that even though it is not a party to this Agreement, it hereby agrees that Section 15 of this Agreement shall be binding upon it.

BY:

/s/ Michael Onuscheck

NAME: Michael Onuscheck

TITLE: President

Definitions

Feasibility Studies

Development

Technology Transfer

Design and development documents, methods, and data

Device specifications

Assembly drawings, including tolerances

Material and component specifications, including tolerances

Material and component supplier capability requirements

Computational design evaluation methods and results, including FEA methods and results

Biomechanics parameters used in design evaluation

Biocompatibility requirements and data

Design verification and validation methods and results, including fatigue testing and biocompatibility testing

Pre-clinical and pre-market human clinical trial methods and results j. MRI performance-related testing methods and results

Process development, manufacturing, and process control documents, methods, and data

Manufacturing instructions and production methods, including connection methodologies and parameters, materials preparation and assembly techniques

Supplier selection process, CPI’s and its Affiliates’ supplier identity and status of supplier relationship

Supplier material and component qualification methods and results

Process validation methods and results

Process control methods and results including sampling plans, test and inspection methods and criteria

Regulatory submission documents, methods and data