Statistical Procedures for the Medical Device Industry

LICENSED PROCEDURE AGREEMENT

RECITALS:

 WHEREAS, Licensor has developed certain procedures and related documents including spreadsheets and graphic files (collectively, the “Licensed Procedures”); and

 WHEREAS, Licensor is the owner of the Licensed Procedures(s); and

 WHEREAS, Licensee desires to license from the Licensor the Licensed Procedures subject to the terms and conditions described herein.

 NOW, THEREFORE, in consideration of the foregoing and the mutual covenants contained herein, the parties hereto agree as follows:

1.  License

In accordance with the terms herein, Licensor grants to Licensee and its Affiliates, and Licensee and each of its Affiliates, accepts from Licensor, a perpetual non-exclusive and non-transferable license to the Licensed Procedure(s) as listed on receipt.  Licensee may not sublicense or otherwise distribute the Licensed Procedure(s) at any time or in any fashion.

The term “Affiliates” shall refer to each entity which Licensee has directly or indirectly a greater than fifty-percent (50%) ownership interest.  In the event that an entity becomes an Affiliate during the term of this Agreement, such entity will be deemed an Affiliate and Permissible User from the date the Affiliate relationship began.  In the event that an entity ceases to be an Affiliate during the term of this Agreement, such entity’s interest in this Agreement will be deemed to have ceased on the date it ceases to be an Affiliate.  Upon loss of an Affiliate, unless the Affiliate obtains their own license, the Licensee will be responsible for removal of all Licensed Procedure(s) and any copies or modifications thereof from the possession of the Affiliate.

Permissible users within the Licensee and each of its Affiliates include employees and Consultants, meaning non-employee independent contractors who are working with or for the Licensee or an Affiliate pursuant to a written agreement.  Further Permissible Users may be agreed upon by written agreement of the Parties.

The Licensed Procedure(s) shall be used solely for internal use in Licensee’s own business.  Licensee shall not:  (1) permit any third party to use the Licensed Procedure(s), except for a Consultant or (2) allow access to the Licensed Procedure(s) outside of Licensee’s customary business practices.  Upon payment in full as indicated herein, Licensee may use the Licensed Procedures including derivative works under the terms of this Agreement without paying further compensation to Licensor.  Derivative works are to be treated the same as the original procedures.

2. Confidentiality

 Licensee acknowledges the confidential and proprietary nature of the Licensed Procedure(s) and agrees that it shall not reveal or disclose Licensed Procedure(s) or the confidential and propriety information contained therein for any purpose to any other person, firm, corporation, or other entity, except for consultants of Licensee performing within the scope of their duties for Licensee.  Licensee agrees to safeguard, secure, and protect the Licensed Procedure(s) from all manner of unauthorized copying, unauthorized disclosure, unauthorized use, theft, or piracy, all in a manner consistent with the manner in which Licensee protects its most confidential information and consistent with the maintenance of Licensor’s rights therein, and agrees that each employee or consultant who is permitted access to the Licensed Procedure(s) shall have executed Licensee’s confidentiality agreement which contains a general covenant to keep confidential information of which he learns or has access to during his engagement by Licensee.  Licensee agrees to inform its employees and consultants of their obligations under this Agreement, and shall take steps as may be reasonable in the circumstances, or as may reasonably be requested by Licensor, to prevent any unauthorized disclosure, copying, or use of the Licensed Procedure(s).

3.  Copies

 The license(s) granted herein include(s) the right to copy the Licensed Procedure(s) in whole or in part as necessary for Licensee’s own business use in conformance with Paragraph 1.  In order to protect Licensor’s copyrights in the Licensed Procedure(s), Licensee agrees to reproduce and incorporate Licensor’s copyright notice in any copies, modifications, or partial copies.  Failure to provide proper notice in reproductions will be considered a material breach of this Agreement and will result in the forfeiture of the license(s).

4.  Payment

Licensee shall make a one-time payment to Licensor for this Licensed Procedure(s) license in the amount listed on invoice or receipt.

5.  Licensor Representations and Warranties

Licensor represents and warrants that it is the owner of the Licensed Procedure(s) and all portions thereof and that it has the right to modify same and to grant Licensee a license for its use.

6.  Intent to Cooperate

Licensor and Licensee acknowledge that successful implementation of the Licensed Procedure(s) pursuant to this License Agreement shall require their full and mutual good faith cooperation, and each of Licensor and Licensee acknowledge that it shall timely fulfill its responsibilities, including, but not limited to, those set forth below.  Notwithstanding, nothing in the foregoing waives each parties’ duty of good faith and fair dealing.

7.  Title to Licensed Procedure(s)

The Licensed Procedure(s), and all supporting materials thereof, developed hereunder and all copies of each are proprietary to Licensor and title thereto remains held by Licensor.  All applicable rights to patents, copyrights, trademarks, and trade secrets, as defined by the common law of the State of Illinois, in the Licensed Procedure(s), or any modifications made either at Licensee’s request pursuant to Paragraph 12 herein or in the discretion of Licensor are and shall remain in Licensor.  Subject to Licensee’s right to distribute to Affiliates described in Paragraph 1 above, Licensee shall not sell, transfer, publish, disclose, display, or otherwise make available the Licensed(s) or copies thereof to others.  Licensee agrees to secure and protect the Licensed Procedure(s), and each module, product, documentation, and copies thereof in a manner consistent with the maintenance of Licensor’s rights therein and to take appropriate action by instruction or agreement with its employees or Consultants who are permitted access to each to satisfy its obligations hereunder.  All copies made by the Licensee of the Licensed Procedure(s) and other procedures developed hereunder, including translations, compilations, partial copies with modifications and up-dated works, are the property of Licensor.  Licensee may modify the Licensed Procedure(s) for its own use as Licensee sees fit.  Licensee may not use any of the Licensed Procedure(s) to develop other information, documentation, materials, or resources to be marketed or sold to third parties that will compete with the Licensed Procedure(s) or Licensor.  Violation of any provision of this paragraph shall be the basis for immediate termination of this Agreement.

8.  Disclaimer of Warranty and Limitation of Liability

 LICENSOR MAKES NO WARRANTIES, AND LICENSOR EXPRESSLY DISCLAIMS, AND LICENSEE HEREBY EXPRESSLY WAIVES, ALL WARRANTIES EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ALL WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.  LICENSOR DOES NOT WARRANT THAT THE LICENSED PROCEDURE(S) WILL MEET LICENSEE’S REQUIREMENTS, AND THE ENTIRE RISK OF THE QUALITY AND PERFORMANCE OF THE LICENSED PROCEDURE(S) IS WITH LICENSEE.

LICENSOR SHALL HAVE NO LIABILITY WITH RESPECT TO ITS OBLIGATIONS UNDER THIS AGREEMENT FOR CONSEQUENTIAL, EXEMPLARY, OR INCIDENTAL DAMAGES EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.  IN ANY EVENT, THE LIABILITY OF LICENSOR TO LICENSEE FOR ANY REASON AND UPON ANY CAUSE OF ACTION SHALL BE LIMITED TO THE AMOUNT PAID TO LICENSOR BY LICENSEE UNDER THIS AGREEMENT.  THIS LIMITATION APPLIES TO ALL CAUSES OF ACTION IN THE AGGREGATE, INCLUDING WITHOUT LIMITATION TO BREACH OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE, STRICT LIABILITY, MISREPRESENTATIONS, AND OTHER TORTS.  BOTH PARTIES UNDERSTAND AND AGREE THAT THE REMEDIES AND LIMITATIONS HEREIN ALLOCATE THE RISKS OF PRODUCT AND SERVICE NONCONFORMITY BETWEEN THE PARTIES AS AUTHORIZED BY THE UNIFORM COMMERCIAL CODE AND ALL OTHER APPLICABLE LAWS.  THE LICENSE FEES HEREIN REFLECT, AND ARE SET IN RELIANCE UPON, THIS ALLOCATION OF RISK AND THE EXCLUSION OF CONSEQUENTIAL DAMAGES SET FORTH IN THIS AGREEMENT.

9.  Indemnity

Licensor hereby agrees to hold Licensee harmless from any and all loss, costs, damages, or expenses (including but not limited to reasonable attorneys’ fees) that may be incurred by Licensee to the extent that it is based on a claim that any Licensed Procedure(s) used within the scope of this License Agreement infringes any patents, copyrights, license or other property right of any third party, provided that Licensor is timely notified in writing of such claim.  Licensee shall be liable for any damage suffered by Licensor to the extent Licensee prejudiced Licensor’s rights by failing to timely notify Licensor of any such claim.  In no event shall Licensee settle any such claim, lawsuit, or proceeding without Licensor’s prior written approval, which approval shall not be unreasonably withheld.

If, as a result of any claim of infringement against any patent, copyright, license or other property right, Licensor is enjoined from using the Licensed Procedure(s), or if Licensor believes that the Licensed Procedure(s) is likely to become the subject of a claim of infringement, Licensor at its option and expense may procure the right for Licensee to continue to use the Licensed Procedure(s), or replace or modify the Licensed Procedure(s) so as to make it non-infringing.  If neither of these two options is reasonably practicable Licensor may discontinue the license granted herein on one month’s written notice and refund to Licensee the unamortized portion of the license fees hereunder (based on four-year straight-line amortization).  The foregoing states the entire liability of Licensor with respect to infringement of any copyrights or patents by the Licensed Procedure(s) or any parts thereof.

Licensee hereby agrees hold Licensor harmless from any and all loss, costs, damages or expenses (including but not limited to reasonable attorney’s fees) that may be incurred by Licensor relating to Licensee’s use of the Licensed Procedures in any manner prohibited by this Agreement.

10.  Termination

Licensor and Licensee shall each have the right to terminate this Agreement and license(s) granted herein:

             (a)        In the event that the other party, its officers, employees, or Consultants breaches any material term of this Agreement including, but not limited to, confidentiality and payment subject to the right to cure described below;

             (b)        In the event the other party (i) terminates or suspends its business;  (ii) becomes subject to any bankruptcy or insolvency proceeding under federal or state statute; or (iii) becomes insolvent or becomes subject to direct control by a trustee, receiver, or similar authority; or

              (c)        In the event the other party breaches a material term of any other licensing agreement that may exist between the parties, in which case, the non-breaching party may elect to terminate any or all said licensing agreements subject to the right to cure described below.

 In the event of termination by reason of the Licensee’s failure to comply with any material term of this Agreement, or upon any act that shall give rise to Licensor’s right to terminate as described in Paragraphs 10(a) or 10(c), the non-breaching party shall provide written notice clearly designated as notice of intent to terminate the Agreement.  Within five (5) business days of written notice, the breaching party shall have the opportunity to cure any breach.  If the breaching party fails to cure, Licensor shall have the right to terminate the license(s) and take immediate possession of the Licensed Procedure(s) and all copies wherever located, without further demand or notice.  Within fifteen (15) days after termination of the license(s), Licensee will return to Licensor the Licensed Procedure(s) in the form provided by Licensor or as modified by the Licensee, or upon request by Licensor destroy the Licensed Procedure(s), and all copies of each, and certify in writing that they have been destroyed.  Termination under this paragraph shall not relieve either party of its obligations regarding confidentiality of the Licensed Procedure(s).  Termination of the Agreement shall be in addition to and not in lieu of any other remedies in law or in equity that may be available to Licensor.  In the event of termination by Licensee following breach of a material term by Licensor, Licensee may retain the perpetual right to use the Licensed Procedures and materials developed for which Licensee pays or has paid amounts due therefor.

Without limiting any of the above provisions, in the event of termination as a result of the Licensee’s failure to comply with any of its material obligations under this Agreement, the Licensee shall continue to be obligated for any payments accrued and owing prior to the date of termination.  Termination of the license(s) shall be in addition to and not in lieu of any equitable remedies available.

11.  Taxes

Licensee shall, in addition to the other amounts payable under this Agreement, pay all sales and other taxes, federal, state, or otherwise, however designated, which are levied or imposed by reason of the license granted to Licensee by this Agreement, except for income taxes imposed upon licensing proceeds received by Licensor.  Without limiting the foregoing, Licensee shall promptly pay to Licensor an amount equal to any such items actually paid, or required to be collected or paid by Licensor, upon reasonable notice thereof, together with supporting documentation.

12.  Custom Modifications

All custom modifications to the Licensed Procedure(s) may be undertaken by Licensor pursuant to the terms of another agreement entered into by and between the parties, the terms of which shall be mutually agreed upon prior to commencement of such custom modification effort.

13.  General

            (a)        Each party acknowledges that it has read this Agreement, it understands it, and agrees to be bound by its terms, and further agrees that this is the complete and exclusive statement of the Agreement between the parties, which supersedes and merges all prior proposals, understandings and all other agreements, oral and written, between the parties relating to this Agreement.  This Agreement may not be modified or altered except by written instrument duly executed by all parties.

             (b)        Dates or times by which either party is required to make performance under this license shall be postponed automatically to the extent that that party is prevented from meeting them by causes beyond its reasonable control.

             (c)        This Agreement and performance hereunder shall be governed by the laws of the State of Illinois, without regard to conflicts of law principles.

             (d)       The parties hereto consent and agree that all legal proceedings relating to the subject matter of this Agreement shall be maintained only in courts sitting within Lake or Cook Counties, Illinois, and each of the parties consents and submits to the jurisdiction of any local, state, or federal court in said counties.  The parties hereto waive any rights to have transferred or changed the venue of any litigation brought against them.

             (e)       No action, regardless of form, arising out of this Agreement may be brought by Licensee more than two years after the cause of action has arisen.

             (f)        If any provision of this Agreement is invalid, illegal, or unenforceable under any applicable statute or rule of law, it is deemed modified to the extent necessary to render the provision enforceable.

             (g)        The Licensee may not assign or sub-license, except to Affiliates and described herein, without the prior written consent of Licensor, its rights, duties, or obligations under this Agreement to any person or entity, in whole or in part.  If Licensee is acquired, Licensee may assign its right under this Agreement to the acquiring company provided appropriate additional license fee has been paid by the acquiring company if it desires to use the Licensed Procedure(s) outside of Licensee’s preexisting businesses. 

             (h)        Each non-breaching party hereto shall have the right to collect from the breaching party each non-breaching party’s reasonable expenses incurred in enforcing this Agreement including, but not limited to, all reasonably incurred attorneys’ fees, experts’ fees, and costs.

             (i)         The waiver or failure of Licensor to exercise in any respect any right provided for herein shall not be deemed a waiver of any further right hereunder.

             (j)         Notice under this Agreement shall be deemed given when: delivered to the party personally, deposited in the U.S. Mail with first class postage prepaid to the party, faxed to the party, or sent via overnight courier with charges prepaid, next day delivery, all to the address or fax number indicated below.

             (k)        In the event of a breach of this Agreement, each party hereto acknowledges that the remedy at law may be inadequate and that the injured party shall be entitled to an injunction restraining such breach without the necessity to post a bond, in addition to all other remedies available in law or equity.  Each party hereto agrees to reimburse the injured party for any and all loss, damages, costs, including but not limited to reasonable attorneys’ fees, and expenses incurred by the injured party in enforcing the provisions of this Agreement.

             (l)         Licensor shall not be required to modify the Licensed Procedure(s) during the course of this Agreement so as to conform to new equipment or hardware, or to modify features or add additional features, except as per agreement of the parties hereto, and for such additional fees and payments and other conditions as the parties hereto shall agree in writing.

             (m)       Licensee agrees and acknowledges that Licensor may sell, license or otherwise distribute the Licensed Procedure(s) to other parties as Licensor sees fit.

             (n)        Licensee agrees and acknowledges that Licensee will look only to Licensor and to no other party with regard to the performance of this Agreement, and that no other party shall be liable for Licensor’s non-performance of this Agreement.

             (o)        This Agreement shall be interpreted as though each party had an opportunity, and did, participate in the drafting hereof.

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