1 EXHIBIT 10.4 ------------ AMENDED AND RESTATED LICENSE AGREEMENT between POLYMEDICA INDUSTRIES, INC. as Licensor and CARDIOTECH INTERNATIONAL, INC., as Licensee 2 TABLE OF CONTENTS Article 1 - DEFINITIONS 1.1 Confidential Information 1 1.2 Effective Date 1 1.3 Licensed Technology 1 1.4 New Inventions 2 1.5 Implantable Medical Device Technology 2 1.6 Implantable Medical Devices 2 Article II - GRANT OF LICENSE 2.1 Practice of Licensed Technology 2 2.2 Quality Controls 3 2.3 Transfer of Information 3 2.4 No Rights by Implication 3 2.5 No Warranty 3 2.6 Representations and Warranties 3 Article III - CONFIDENTIAL INFORMATION 3.1 Confidentiality Maintained 5 3.2 Information in Connection with Sale 5 Article IV - PROTECTION OF LICENSED TECHNOLOGY 4.1 Litigation with Third Parties 5 4.2 Use of Name in Suit 6 4.3 Notification of Suit by Licensee 6 4.4 Notification of Suit by Licensor 6 Article V - OWNERSHIP OF PROPRIETARY RIGHTS 5.1 Acknowledgment of Existing Rights 6 5.2 Rights to New Inventions 7 Article VI - TERMINATION AND EXPIRATION 6.1 Expiration; Term of Agreement 8 6.2 Bankruptcy 8 6.3 Material Breach 8 6.4 No Right of Licensor to Terminate 8 6.5 After Termination or Expiration 8 3 Article VII - NON-COMPETITION 7.1 Warranty of Non-Competition 9 Article VIII - MISCELLANEOUS 8.1 Assignments 9 8.2 Sublicense 9 8.3 Governing Law 9 8.4 Arbitration 9 8.5 Waiver 10 8.6 No Other Relationship 10 8.7 Notices 10 8.8 Entire Understanding 11 8.9 Invalidity 11 8.10 Amendments 11 8.11 Bard Access Systems, Inc. Agreement 11 8.12 Survival of Contents 11 8.13 Table of Contents and Headings 11 8.14 Exhibit 12 EXHIBIT A List of Patents, Trademarks, 13 Service Marks, Copyrightable Material, Rights, Trade Secrets and Other Proprietary Rights 4 AMENDED AND RESTATED LICENSE AGREEMENT THIS AMENDED AND RESTATED LICENSE AGREEMENT is made and entered into as of the 9th day of May, 1996 by and between PolyMedica Industries, Inc. ("Licensor"), a Massachusetts corporation having offices at 11 State Street, Woburn, Massachusetts 01801 with Telecopy No. (617) 933-7992 and CardioTech International, Inc. ("Licensee"), a Massachusetts corporation having offices at 11 State Street, Woburn, Massachusetts 01801 with Telecopy No. (617) 933-4772. WHEREAS, Licensor possesses certain intellectual property rights which Licensee is desirous of using. Licensor is willing to grant Licensee exclusive rights to use and practice such intellectual property rights in accordance with the terms and conditions hereinafter set forth. Licensor and Licensee have entered into a License Agreement, dated as of March 19, 1996, and by mutual agreement desire to amend and restate that Agreement pursuant hereto. NOW, THEREFORE, in consideration of the premises and mutual promises, terms and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties do hereby agree as follows: I. DEFINITIONS As used herein, the following terms shall have the following definitions: 1.1 CONFIDENTIAL INFORMATION. "Confidential Information" shall mean that part of the Licensed Technology which is not publicly known. 1.2 EFFECTIVE DATE. "Effective Date" shall mean the date on which Licensor executes this Agreement. 1.3 LICENSED IMPLANTABLE MEDICAL DEVICE TECHNOLOGY. "Licensed Technology" shall mean any and all patents, trademarks, service marks, copyrightable material, trade secrets and other proprietary rights including without limitation all such rights listed in Exhibit A that relate to Implantable Medical Device Technology as defined herein. Exhibit A may be amended from time to time by the mutual consent of the parties hereto. If any additional United States Letters Patent or foreign patents are issued based on any of the proprietary rights listed in Exhibit A that relate to Implantable Medical Device Technology as defined herein, such patents shall be deemed to be included in Exhibit A -1- 5 as of their date of issuance for the same purpose as the other patents listed in Exhibit A. 1.4 NEW INVENTIONS. "New Inventions" means any and all inventions, discoveries, concepts, ideas, improvements, original works of authorship, know-how, modifications to existing copyrightable works of authorship and data (whether or not patentable or subject to copyright or trade secret protection) concerning any present or prospective activities of Licensor or Licensee, which Licensor or Licensee, or their respective employees, agents or representatives formulate, make, conceive or become acquainted with during the term of this Agreement that relate to Implantable Medical Device Technology as defined herein. 1.5 "IMPLANTABLE MEDICAL DEVICE TECHNOLOGY" shall mean Implantable Medical Devices, the equipment used to fabricate such Implantable Medical Devices, methods of manufacturing and/or using Implantable Medical Devices, biostable polyurethane material that is used to fabricate such Implantable Medical Devices, and biodurable polymer materials (that are sold in bulk) that are used for medical applications. 1.6 IMPLANTABLE MEDICAL DEVICES. "Implantable Medical Devices" shall mean (i) invasively implantable medical devices which are designed to be implanted by a licensed and/or trained medical or health care professional that are wholly or partially implanted in the body of a human or animal and (ii) any product, system, component, part, or item which either: (a) embodies any of the inventions, discoveries, concepts, ideas, improvements, original works of authorship, know-how or data (whether or not patentable or subject to copyright, or trade secret protection) included in the Licensed Technology; or (b) is produced through the use of any of the inventions, discoveries, concepts, ideas, improvements, original works of authorship, know-how or data (whether or not patentable or subject to copyright or trade secret protection) included in the Licensed Technology. II. GRANT OF LICENSE Subject to all of the terms and conditions set forth in this Agreement: 2.1 PRACTICE OF LICENSED TECHNOLOGY. Licensor hereby grants to Licensee a perpetual, irrevocable, worldwide, royalty-free, exclusive right and license, except as provided in Section 6 even as to the Licensor, to use and practice the Licensed Technology and to make, use, sell, and import Implantable Medical Devices, with the unrestricted right to sublicense the Licensed Technology. Such license shall not be terminable by Licensor or any successor or assign of Licensor or any party claiming through Licensor under any circumstance or for any reason, including without limitation any breach of this Agreement or any other agreement between Licensor and Licensee. -2- 6 2.2 QUALITY CONTROLS. If Licensee, in its sole discretion, uses any trademarks or service marks included in the Licensed Technology on any Implantable Medical Device, Licensee agrees that such use shall be in strict compliance with the provisions of all applicable laws and regulations. Licensee also agrees to conduct any and all advertising and promotion in which such trademarks or service marks are used so as to assure the continued validity and enforceability of those trademarks and service marks. Licensor shall have the right to inspect Licensee's facilities during normal business hours, without prior advance notice, to confirm that Licensee's use of such trademarks and service marks is in compliance with this Section 2.2. 2.3 TRANSFER OF INFORMATION. As soon as practicable after the Effective Date, but in no event later than sixty (60) days after the Effective Date, Licensor shall provide to Licensee, at no cost to Licensee, any and all trade secrets and other proprietary information described in Exhibit A. 2.4 NO RIGHTS BY IMPLICATION. No rights or licenses with respect to Licensed Technology or the Implantable Medical Devices are granted or deemed granted hereunder or in connection herewith, other than those rights or licenses expressly granted in this Agreement. 2.5 NO WARRANTY. EXCEPT AS SET FORTH IN SECTION 2.6, LICENSEE ACKNOWLEDGES THAT IT RECEIVES THE LICENSED TECHNOLOGY ON AN "AS IS" BASIS. THERE IS NO WARRANTY OF LICENSOR IN THIS AGREEMENT CONCERNING THE LICENSED TECHNOLOGY OR THE IMPLANTABLE MEDICAL DEVICES, AND LICENSOR MAKES NO WARRANTY, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 2.6 REPRESENTATIONS AND WARRANTIES. (A) Licensor hereby represents and warrants that: (1) Licensor has full power and authority to execute, deliver and perform this Agreement. (2) This Agreement has been duly executed and delivered by Licensor and constitutes the valid and binding obligation of Licensor, enforceable against Licensor in accordance with its terms, except as limited by principles of equity and applicable bankruptcy, insolvency, and other laws of general applicability affecting the enforcement of creditors' rights. (3) Licensor represents and warrants that it is the owner of the entire right, title, and interest in and to Licensed Technology, except for a joint ownership interest of Thermedics, Inc., a Massachusetts corporation, having offices at 470 Wildwood Street, Woburn, MA 01888, with Licensor in and to U.S. Patent No. 5,254,662 and its related patents and applications in Australia, Canada, the EPO, and WO, as set forth in Exhibit A -3- 7 hereto as "Joint Patents and Patent Applications." To the best of Licensor's knowledge and except set forth in this Section 2.6 (c), the Licensed Technology is free and clear of any lien or similar encumbrance. (4) The Licensor represents and warrants that it has the right to grant the exclusive right in Section 2.1, without requiring the consent or approval of any third party to this Agreement, with regard to Licensor's entire right, title, and interest in and to the Licensed Technology. In the event that, as a result of Thermedics, Inc.'s joint ownership in the patents and patent applications set forth in Exhibit A as "Joint Patents and Patent Applications," in the written opinion of patent counsel for Licensee, the consent of Thermedics, Inc. is required by the law of a foreign country for the grant of the license set forth herein, Licensor will use its best efforts to obtain such consent. If such consent is not granted by Thermedics, Inc. in writing within sixty (60) days after the date of Licensee's request for such consent, then, at the request of Licensee, Licensor will execute and deliver to Licensee an assignment, in mutual satisfactory form, conveying to Licensee an undivided joint interest in and to Licensor's joint ownership of the right, title and interest in and to the specific patent or patent application of the "Joint Patents and Patent Applications" in Exhibit A for which Thermedics, Inc. did not grant its consent. If such an assignment is granted, the result will be that the specific patent or patent application of the "Joint Patents and Patent Applications" in Exhibit A will be jointly owned by Licensor, Licensee and Thermedics, Inc. in the foreign country at issue. (5) Licensor represents and warrants that the execution and delivery of this Agreement is not inconsistent with any prior agreements or instruments regarding Licensed Technology to which the Licensor is bound. (B) Licensee hereby represents and warrants that: (1) Licensee has full power and authority to execute, deliver and perform this Agreement. (2) This Agreement has been duly executed and delivered by Licensee and constitutes the valid and binding obligation of Licensee, and its successors and assigns, enforceable against Licensee, and its successors and assigns, in accordance with its terms, except as limited by principles of equity and applicable bankruptcy, insolvency, and other laws of general applicability affecting the enforcement of creditors' rights. (3) Licensee represents and warrants that the execution and delivery of this Agreement is not inconsistent with any prior agreements or instruments regarding Licensed Technology to which the Licensee is bound. -4- 8 III. CONFIDENTIAL INFORMATION 3.1 CONFIDENTIALITY MAINTAINED. Licensee acknowledges that Licensor will provide Licensee with Confidential Information in the transfer of information pursuant to Section 2.3. All disclosures which have utility for purposes other than Implantable Medical Devices made to Licensee, its agents and employees shall be held in strict confidence by Licensee, its agents and employees. Licensee shall disclose all such Confidential Information that relates to information other than information relating to Implantable Medical Devices only to those of its agents and employees to whom it is necessary in exercising its rights and carrying out its duties under this Agreement. Licensee shall not use the Confidential Information except for the purposes of exercising its rights and carrying out its duties hereunder, including, without limitation, its right to grant sublicenses. The provisions of Section 3.1 shall also apply to any consultants, subcontractors or sublicensees that Licensee may engage in connection with the exercise of its rights or the carrying out of its duties under this Agreement. 3.2 INFORMATION IN CONNECTION WITH SALE. Licensor hereby grants to Licensee the right during the term of this Agreement to sell and distribute in connection with each sale of an Implantable Medical Device that part of the Licensed Technology necessary (in the sole and absolute judgement of Licensee) for such purchaser to use and operate such Implantable Medical Device, even if such information includes Confidential Information. IV. PROTECTION OF LICENSED TECHNOLOGY 4.1 LITIGATION WITH THIRD PARTIES. (a) Licensee shall have the right, but not the obligation, to take any and all actions in its own name, legal or otherwise, which are necessary to: (i) terminate infringements of any proprietary right which is part of the Licensed Technology; or (ii) terminate any attempted passing-off by imitation of any Implantable Medical Device. Licensee shall bear all the expenses of all actions which it initiates pursuant to Section 4.1(a). Any recoveries or settlement fees received from suits or settlements involving an action initiated pursuant to this section 4.1(a) or agreed to shall be paid to Licensee for its own use and benefit. (b) If Licensee does not bring an action, legal or otherwise, which Licensor, believes, in its reasonable judgment, is necessary to protect Licensor's rights related to the underlying Licensed Technology, Licensor, at its sole discretion, may take any and all actions, legal or otherwise, which are necessary to: (i) terminate infringements of any proprietary right which is part of the licensed Technology; or (ii) terminate any attempted passing off by imitation of any Implantable Medical Device. Licensor shall bear all the expenses of all actions which it initiates pursuant to this Section 4.1(b). Any recoveries or -5- 9 settlement fees received from suits or settlements involving an action initiated pursuant to this Section 4.1(b) or agreed to shall be paid to Licensor for its own use and benefit. (c) Licensor may agree to any settlement of any such action brought under Section 4.1(b), at its own discretion, without the prior consent of Licensee so long as such settlement does not grant any rights relating to Implantable Medical Devices to Licensed Technology and does not impose any obligation on Licensee. (d) Licensor shall have the right to take any and all actions in its own name, legal or otherwise, which are necessary to protect the exclusive rights licensed to it by Licensee under Section 5.2(a) relating to Licensee's New Inventions against infringement through the manufacture, use, sale or import by third parties of products which are not Implantable Medical Devices. 4.2 USE OF NAME IN SUIT. When, in the reasonable judgment of Licensor, it is necessary to use Licensee's name to prosecute or defend an action pursuant to Section 4.1 hereof, Licensee agrees to allow Licensor to so use its name; and when, in the judgment of Licensee, it is necessary to use Licensor's name to prosecute or defend an action pursuant to Section 4.1 hereof, Licensor agrees to allow Licensee to use its name. 4.3 NOTIFICATION OF SUIT BY LICENSEE. Licensee shall notify Licensor in writing of the initiation of any actions by third parties against the Licensee or Licensee's initiation of any actions against any third party under Section 4.1(a). Such notice shall be given promptly after Licensee acquires such knowledge. 4.4 NOTIFICATION OF SUIT BY LICENSOR. Licensor shall notify Licensee in writing of the initiation of any actions by third parties against the Licensor or Licensor's initiation of any actions against any third party under Section 4.1(b) and/or relating to the Licensor's exclusive rights licensed to it by Licensee under Section 5.2(a) relating to Licensee's New Inventions. Such notice shall be given promptly after Licensor acquires such knowledge. V. OWNERSHIP OF PROPRIETARY RIGHTS 5.1 ACKNOWLEDGMENT OF EXISTING RIGHTS. (a) Licensee hereby acknowledges that each and every part of the Licensed Technology on the Effective Date and any addition to the Licensed Technology by Licensor during the term of this Agreement is either: (i) the property of Licensor; or (ii) has been used by Licensee pursuant to a grant of rights to Licensor by the owner of such rights to use such rights. (b) Licensee agrees for itself and its successors and assigns, upon request of Licensor, to at all times do such acts -6- 10 and to execute and deliver promptly to Licensor such papers, instruments and documents, at Licensor's expense, as from time to time may be necessary or useful in Licensor's opinion to prove, apply for, secure, maintain, reissue, extend or defend Licensor's world-wide rights in the rights described in Section 5.1(a) above. Without limiting the foregoing, Licensee shall enter into such user agreements with Licensor as necessary to secure Licensor's ownership rights described in Section 5.1(a), in forms mutually agreed upon by Licensor and Licensee. (c) Licensee warrants and represents to Licensor that Licensee, and to Licensee's knowledge the employees, agents, or representatives that it hires or employs, are not subject to any agreement inconsistent with this Agreement regarding the rights described in Section 5.1(a) above. 5.2 RIGHTS TO NEW INVENTIONS. (a) For all New Inventions that relate to Implantable Medical Device Technology as defined herein and which have utility for products which are not Implantable Medical Devices that are formulated, made or conceived by Licensee, its employees, agents and representatives, solely or jointly with others, during the term of this Agreement, with respect to which Licensee acquires any patents, trademarks, service marks, copyrightable material, trade secrets or any other proprietary rights which Licensee has the right to license to others, any and all such rights of Licensee shall be owned by Licensee and Licensee shall grant Licensor a perpetual, irrevocable, world-wide, royalty-free, exclusive right and license, exclusive of Implantable Medical Device Technology as defined herein, even as to Licensee, during the term of this Agreement, to use and practice such New Inventions and to make, use and sell products which are not Implantable Medical Devices with the right to sublicense such New Invention solely for such purpose. Such exclusive license to Licensor for Licensee's New Inventions is in consideration of the royalty-free license granted to Licensee pursuant to Section 2.1 above. Licensee shall take no actions to defeat Licensor's rights under Section 5.2(a). (b) Licensee shall inform Licensor fully of each of Licensee's New Inventions which have utility for products which are not Implantable Medical Devices by a written report, setting forth in detail the procedures employed and results achieved. Such report shall be given to Licensor within ninety days after the formulation, making or conception of such New Inventions. Licensee shall also provide Licensor with an annual report identifying all such New Inventions of Licensee formulated, made or conceived during the twelve (12) month period covered by that report. (c) For all New Inventions that relate to Implantable Medical Device Technology as defined herein, that are formulated, made or conceived by Licensor, its employees, agents and representatives, solely or jointly with others, during the term of -7- 11 this Agreement with respect to which Licensor acquires any patents, trademarks, service marks, copyrightable material, trade secrets or any other proprietary rights, it shall be deemed to be part of the Licensed Technology and Licensee shall have a right to use such rights, title and interest pursuant to Section 2.1 hereof without paying any royalty or any other consideration to Licensor. Licensor shall take no actions to defeat Licensee's rights under Section 5.2(c). (d) Licensor shall inform Licensee fully of each of Licensor's New Inventions which have utility for products which are Implantable Medical Devices by a written report, setting forth in detail the procedures employed and results achieved. Such report shall be given to Licensee within ninety days after the formulation, making or conception of such New Inventions. Licensor shall also provide Licensee with an annual report identifying all such New Inventions of Licensor formulated, made or conceived during the twelve (12) month period covered by that report. VI. TERMINATION AND EXPIRATION 6.1 EXPIRATION: TERM OF AGREEMENT. Unless it is terminated by mutual agreement, this Agreement shall continue in full force and effect perpetually. The term of this Agreement shall be from the Effective Date to the date of termination or expiration of this Agreement, as the case may be. 6.2 BANKRUPTCY. If Licensee, voluntarily or involuntary, is subject to bankruptcy under Chapter 7 of the Bankruptcy code, the purchaser, assignee, or other entity who obtains in any way any rights of Licensee under this Agreement shall have no right to bring any action against any third party pursuant to Section 4.1(a) hereof. 6.3 MATERIAL BREACH. Upon the occurrence of a curable material breach or default as to any obligation hereunder by Licensee and the failure of Licensee to promptly pursue (within ninety (90) days after receiving written notice thereof from Licensor) a reasonable remedy designed to cure (in the reasonable judgment of Licensor) such curable material breach or default, Licensee agrees to pay Licensor $1,000.00 per day after the 90 day period has expired until the curable material breach or default is cured. 6.4 NO RIGHT OF LICENSOR TO TERMINATE. In the event of a material breach of any of the provisions hereof by Licensee, Licensor may seek to recover monetary damages against Licensee in accordance with Section 8.4 hereof. Licensor shall not have the right to unilaterally terminate this Agreement. Licensor's sole remedy shall be the recovery of monetary damages. 6.5 AFTER TERMINATION OR EXPIRATION. The parties hereto agree that, once this Agreement is terminated or expires, Licensee shall immediately cease any use or practice of the Licensed -8- 12 Technology. Licensee shall, at its expense, return to Licensor all Confidential Information as soon as practicable after the date of such termination or expiration, including, but not limited to, original documents, drawings, computer diskettes, models, samples, notes, reports, notebooks, letters, manuals, prints, memoranda and any copies thereof, which have been received by Licensee. All such Confidential Information shall be owned by Licensor during the term of this Agreement and thereafter. VII. NON-COMPETITION 7.1 WARRANTY OF NON-COMPETITION. Licensee agrees that it will not directly or knowingly indirectly compete with PMI in the following areas for a period of five calendar years from the Effective Date of this Agreement: (1) Prescription or over-the-counter Wound Dressing Business. (2) Cosmetic Business, including but not limited to, active ingredients and finished cosmetic products. VIII. MISCELLANEOUS 8.1 ASSIGNMENTS. This Agreement and any and all of the rights and obligations of either party hereunder shall not be assigned, delegated, sold, transferred or otherwise disposed of, by operation of law or otherwise, without the prior written consent of the other party, which consent shall not be unreasonably withheld, provided that either party may sell, assign, transfer, delegate or otherwise dispose of its rights and obligations hereunder in connection with its merger or consolidation or the sale of all or substantially all of its assets. This Agreement shall be binding upon, and inure to the benefit of, Licensor and Licensee and their respective successors and assigns, to the extent such assignments are in accordance with Section 8.1. 8.2 SUBLICENSE. Licensee shall have the right to sublicense the Licensed Technology to a third party under this Agreement as long as the third party agrees to be bound by the terms of this Agreement to the same extent as the Licensee, and any sublicensing agreement made with such third party by Licensee shall expressly incorporate by reference the terms of this Agreement. 8.3 GOVERNING LAW. This Agreement shall be governed, interpreted and construed in accordance with the laws of the Commonwealth of Massachusetts. 8.4 ARBITRATION. (a) Any dispute, controversy or claim arising out of or relating to this Agreement or to a breach thereof, including its interpretation or performance, shall be finally resolved by arbitration. The arbitration shall be conducted in accordance with -9- 13 the rules of the American Arbitration Association, which shall administer the arbitration and act as appointing authority. The arbitration, including the rendering of the award, shall take place in Boston, Massachusetts and shall be the exclusive forum for resolving such dispute, controversy or claim. For the purposes of this arbitration, the provisions of this Agreement and all rights and obligations thereunder shall be governed and construed in accordance with the laws of the Commonwealth of Massachusetts. The decision of the arbitrators shall be final and binding upon the parties hereto, and the expense of the arbitration shall be paid as the arbitrators determine. The decision of the arbitrators shall be executory, and judgment thereon may be entered by any court of competent jurisdiction. Notwithstanding this, judgment upon the award of the arbitration may be entered in any court where the arbitration takes place or any court having jurisdiction thereof, and application may be made to any court for a judicial acceptance of the award or order of enforcement. (b) Notwithstanding anything contained in Section 8.4(a) above to the contrary, each party shall have the right to institute judicial proceedings against the other party or anyone acting by, through or under such other party in order to enforce the instituting party's rights hereunder through reformation of contract, specific performance, injunction or similar equitable relief. 8.5 WAIVER. A waiver of any breach or any provision of this Agreement shall not be construed as a continuing waiver of other breaches of the same or other provisions of this Agreement. 8.6 NO OTHER RELATIONSHIP. Nothing herein contained shall be deemed to create an agency, joint venture or partnership relationship between the parties hereto. Neither party shall have any power to enter into any contracts or commitments in the name of, or on behalf of, the other party, or to bind the other party in any respect whatsoever except as specified in this Agreement. 8.7 NOTICES. Each notice required or permitted to be sent under this Agreement shall be given by telecopy transmission or by registered or recorded delivery letter to the parties at the addresses and telecopy numbers indicated above. Either party may change its address and/or telecopy number, for purposes of this Agreement, by giving the other party written notice of its new address and/or telecopy number. Any notice if given or made by registered or recorded delivery letter shall be deemed to have been received on the earlier of the date actually received and the date five (5) days after the same was posted (and in proving such it shall be sufficient to prove that the envelope containing the same was properly addressed and posted as aforesaid) and if given or made by telecopy transmission shall be deemed to have been received at the time of dispatch, unless such date of deemed receipt is not a day on which banks are open for business in Boston, Massachusetts in which case the date of deemed receipt -10- 14 shall be the next succeeding day on which banks are open in Boston, Massachusetts. 8.8 ENTIRE UNDERSTANDING. This Agreement embodies the entire understanding between the parties relating to the subject matter hereof, whether written or oral, and there are no prior representations, warranties or agreements between the parties not contained in this Agreement. 8.9 INVALIDITY. If any provision of this Agreement is declared invalid or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall endure except for the part declared invalid or uInenforceable by order of such court. 8.10 AMENDMENTS. Any amendment or modification of any provision of this Agreement must be in writing, dated and signed by both parties hereto. 8.11 BARD ACCESS SYSTEMS, INC. AGREEMENT. (a) Licensor hereby assigns all of its rights, interests, and duties under the Development, Supply and License Agreement (the "Bard Agreement"), dated November 11, 1992, between Bard Access Systems, Inc. having offices at 5425 West Amelia Earhart Drive, Salt Lake City, Utah 84116 ("Bard"), and Licensor to Licensee, and Licensee agrees to assume all of Licensor's rights, interests, and duties under the Bard Agreement between Bard and Licensor. (b) Licensor shall be liable for any obligations, claims, or liabilities relating to, or arising out of, the Bard Agreement and incurred prior to the Effective Date and hereby agrees to indemnify and hold harmless Licensee from and against any such obligations, claims, or liabilities. Licensee shall be liable for any obligations, claims, or liabilities relating to, or arising out of, the Bard Agreement and incurred on and after the Effective Date and hereby agrees to indemnify and hold harmless Licensor from and against any such obligations, claims, or liabilities. Licensor acknowledges that Bard must consent to the foregoing assignment and that representatives of Licensee will contact Bard to obtain such consent and negotiate appropriate amendments to the Bard Agreement to reflect this assignment. 8.12 SURVIVAL OF CONTENTS. Notwithstanding anything else in this Agreement to the contrary, the parties agree that Sections 2.2, 2.4, 2.5, 2.6, 3.1, 4.1, 4.2, 4.3, 5.1, 6.5, 7.1, 8.1, 8.2, 8.3, 8.5, 8.6, 8.7, 8.8 and 8.10 shall survive the termination or expiration of this Agreement to the extent required hereby for the full observation and performance by either or both of the parties hereto. 8.13 TABLE OF CONTENTS AND HEADINGS. Any table of contents accompanying this Agreement and any headings contained herein are -11- 15 for directory purposes only, do not constitute a part of this Agreement, and shall not be employed in interpreting this Agreement. 8.14 EXHIBIT. The exhibit referred to in this Agreement is attached hereto and incorporated herein by this reference. IN WITNESS WHEREOF, the parties hereto have signed this Agreement. POLYMEDICA INDUSTRIES, INC., as Licensor By /s/ Steven James Lee ------------------------------ Name: Steven James Lee Title: President Date Licensor Executed this Agreement: May 9, 1996 ----------------- CARDIOTECH INTERNATIONAL, INC., as Licensee By /s/ Michael Szycher ------------------------------ Name: Michael Szycher Title: President -12- 16 Exhibit A to License Agreement LIST OF PATENTS, TRADEMARKS, SERVICE MARKS, COPYRIGHTABLE MATERIAL, RIGHTS, TRADE SECRETS AND OTHER PROPRIETARY RIGHTS TRADEMARKS ---------- Trademark Intl. Class Registration No. --------- ----------- ---------------- CHRONOFILM 17 1,691,545 CHRONOFLEX 17 1,762,851 PATENTS ------- Publication/ Patent Appln. No./ Filing/ Patent No. Country Title Issue Date ---------- ------- ----- ---------- 5,118,779 U.S. Hydrophilic Polyurethane 06/02/92 Elastomers JOINT PATENTS AND PATENT APPLICATIONS ------------------------------------- Publication/ Patent Appln. No./ Filing/ Patent No. Country Title Issue Date 9186454 Australia Biostable Polyurethane 03/30/92 Products 2091564 Canada Biostable Polyurethane 03/13/92 Products 548256 EPO Biostable Polyurethane 07/07/93 Products 5,254,662 U.S. Biostable Polyurethane 10/19/93 Products -13- 17 9204390 WO Biostable Polyurethane 03/19/92 Products Together with all divisions, continuations, continuations-in-part, substitutions, reissues, extensions, reexaminations and foreign equivalents of the foregoing. -14- 18 Other ----- All trade secrets, know-how, copyrightable material, or other proprietary rights that relate to the above-listed patents or patent applications, or generally to the Licensed Technology, that will be necessary to practice the Licensed Technology, including the above-listed patents or patent applications. -15-