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AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

AMENDED AND RESTATED LICENSE AGREEMENT | Document Parties: American Medical Systems, Inc | Bio Control Medical (BCM), Ltd You are currently viewing:
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American Medical Systems, Inc | Bio Control Medical (BCM), Ltd

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Title: AMENDED AND RESTATED LICENSE AGREEMENT
Governing Law: New York     Date: 3/3/2009
Industry: Medical Equipment and Supplies     Law Firm: Oppenheimer Wolff     Sector: Healthcare

AMENDED AND RESTATED LICENSE AGREEMENT, Parties: american medical systems  inc , bio control medical (bcm)  ltd
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Exhibit 10.30

AMENDED AND RESTATED LICENSE AGREEMENT

          THIS AMENDED AND RESTATED LICENSE AGREEMENT (this “ Agreement ”) is made and entered into effective as of January 1, 2008 (the “ Effective Date ”), by and between Bio Control Medical (B.C.M), Ltd., an Israeli company (“ Bio Control ”), and American Medical Systems, Inc., a Delaware corporation (“ AMS ”).

Recitals

          A. Bio Control and AMS are parties to that certain Asset Purchase Agreement dated April 26, 2006 (the “ Asset Purchase Agreement ”), pursuant to the terms of which AMS purchased certain assets of Bio Control’s Urology Business, as defined therein, excluding certain intellectual property rights that were subject to the terms of a related original License Agreement by and between Bio Control and AMS dated April 26, 2006 (the “ License Agreement ”).

          B. Subsequent to entering into the License Agreement, Bio Control and AMS determined that it is in their best interests to transfer certain patents and patent applications originally licensed to AMS under the License Agreement, to AMS, with AMS granting to Bio Control certain license rights therein, as reflected in a Non-Binding Memorandum of Understanding, dated September 25, 2007, between Bio Control and AMS (the “ Memorandum of Understanding ”).

          C. Bio Control and AMS wish to amend and restate the License Agreement in its entirety exclusively on the terms and conditions provided in this Agreement.

Agreement

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

1. Definitions.

(a) “Affiliate” means, with respect to any Person, any Person directly or indirectly controlling, controlled by or under direct or indirect common control with such other Person.

(b) “AMS Patents” means those patents and patent applications listed on Exhibit B hereto.

(c) “AMS Patent Rights” as used in this Agreement means each and all of the following: (i) all right, title and interest of AMS and its Affiliates in the AMS Patents and any patents issuing on any patent applications, including any reissues, re-examinations, provisionals, divisionals, continuations and continuations-in-part, and extensions thereof; and (ii) any corresponding foreign patents or patent applications related or claiming priority thereto, in each case to the extent not already included in the AMS Patents or in the Transferred Intellectual Property (as defined in the Asset Purchase Agreement).

(d) “Bio Control Patents” means all of Bio Control’s patents and patent applications as in existence on April 26, 2006, including, but not limited to, those listed on Exhibit A hereto.

(e) “Bio Control Patent Rights” as used in this Agreement means each and all of the following: (i) all right, title and interest of Bio Control and its Affiliates in the Bio Control Patents and any patents issuing on any patent applications, including any reissues, re-examinations, provisionals, divisionals, continuations and continuations-in-part, and extensions thereof; and (ii) any corresponding foreign patents or patent applications related or claiming priority thereto, in each case to the extent not already included in the Bio Control Patents.

(f) “Confidential Information” means any information that is disclosed in any tangible form and is clearly labeled or marked as confidential, proprietary or its equivalent, and any information that is disclosed orally or visually, is designated confidential, proprietary or its equivalent at the time of its disclosure and is reduced to writing and clearly marked or labeled as confidential, proprietary or its equivalent within thirty (30) days of disclosure, including, without limitation, any non-public information of a disclosing party or its Affiliates, and any scientific or technical data, know-how or expertise of a disclosing party or its Affiliates that relates to a Licensed Product of such disclosing party or its Affiliates (whether existing at or

 


 

after the Effective Date); provided, however, that “Confidential Information” shall not include information that (i) was in the receiving party’s possession or was known to it prior to its receipt from the disclosing party; (ii) is or becomes public knowledge without the fault of the receiving party; (iii) is or becomes rightfully available on an unrestricted basis to the receiving party from a source other than a party owing an obligation of confidentiality to the disclosing party; or (iv) becomes available on an unrestricted basis to a third party from the disclosing party or from someone acting under its control.

(g) “AMS Field of Use” means the field of urology, gynecology, colorectal disorders, sexual dysfunction and related pelvic disorders.

(h) “Governmental Authority” means any foreign, domestic, federal, territorial, state or local governmental authority, quasi-governmental authority, instrumentality, court, government or self-regulatory organization, commission, tribunal or organization or any regulatory, administrative or other agency, or any political or other subdivision, department or branch of any of the foregoing.

(i) “Intellectual Property Rights Licensed to AMS” means the following: (i) the Bio Control Patent Rights; (ii) the Urology Business Information; and (iii) all copyrights, trade secrets, know-how and other proprietary rights related thereto.

(j) “Intellectual Property Rights Licensed to Bio Control” means the following: (i) the AMS Patent Rights and (ii) all copyrights, trade secrets, know-how and other proprietary rights related thereto.

(k) “Licensed Intellectual Property Rights” means the Intellectual Property Rights Licensed to Bio Control or the Intellectual Property Rights Licensed to AMS, as the case may be.

(l) “Licensed Products” means a Licensed Product of Bio Control or a Licensed Product of AMS, as the case may be.

(m) “Licensed Products of AMS” means any product or device that is developed, designed, modified, improved, manufactured, used, imported, sold or offered for sale by AMS in the AMS Field of Use that (x) in the absence of this Agreement, would infringe one or more Valid and Enforceable Claims of the Bio Control Patent Rights or (y) would infringe one or more Valid and Enforceable Claims of the patent rights included in the Transferred Intellectual Property (as defined in the Asset Purchase Agreement).

(n) “Licensed Products of Bio Control” means any product or device that is developed, designed, modified, improved, manufactured, used, imported, sold or offered for sale by Bio Control, any licensee of or transferee from Bio Control outside the AMS Field of Use that, in the absence of this Agreement, would infringe one or more Valid and Enforceable Claims of the AMS Patent Rights.

(o) “Licensee” means Bio Control or AMS in its capacity as licensee under Section 2(a) or Section 2(b), as the case may be.

(p) “Licensor” means Bio Control or AMS in its capacity as licensor under Section 2(a) or Section 2(b), as the case may be.

(q) “Net Sales” means AMS’, or, in the case of any sublicensee, the sublicensee’s properly recognized consolidated aggregate net sales of Licensed Product during the royalty period provided in Section 3 hereof, calculated in accordance with generally accepted accounting principles in the U.S.A. consistently applied by AMS in accordance with its audited revenue recognition policies, reduced by the allowance for bad debts recorded related to the revenue. Whenever a Licensed Product is sold as part of a bundled product, the “Net Sales” for the Licensed Product resulting from such sale of such bundled product shall be the product of (X) the net revenues reported by AMS or its Affiliate or a sublicensee, whichever is applicable, for such bundled product multiplied by (Y) a fraction, the numerator of which is the per unit average selling price of such Licensed Product and the denominator of which is the sum of the aggregate per unit average selling prices of all products, including the Licensed Product, included in such bundled product.

(r) “Patent Rights” means the Bio Control Patent Rights or the AMS Patent Rights, as the case may be.

(s) “Person” means an individual, corporation, partnership, limited liability company, association, trust, estate or other entity or organization, including a Governmental Authority.

 


 

(t) “Software” means all the series of instructions and algorithms which operate the miniaturo™ Bio Control Device and physician programmer.

(u) “Source Code” means the series of statements written in human-readable computer programming language which, when complied into machine-readable format, constitute the Software.

(v) “Urology Business Information” means the following business information and related records as in existence on the date hereof to the extent used in or applicable to the Urology Business:

(i) documentation related to the design, validation, and production of the miniaturo™ current model of Bio Control Device, physician programmer, stimulation lead, system accessories, test fixtures and manufacturing fixtures;

(ii) documentation related to the assembly of Bio Control Devices, including: (A) process flow charts, process standard operating procedures (SOPs), (B) copies of all equipment drawings and manuals, (C) calibration records for all equipment and other fixed assets; (D) sterilization cycle validation reports, (E) drawing of molds needed to manufacture parts for the miniaturo™, (F) floor plan and equipment list for a facility capable of performing the manufacturing steps of the miniaturo™ currently performed by Bio Control, and (G) floor plan, equipment list and software list for a facility capable of performing the development process currently performed by Bio Control;

(iii) lists of vendors and suppliers, including addresses and telephone numbers, if possible, and a breakdown of purchases by vendor or supplier;

(iv) details of expected cost of goods sold and other manufacturing costs for Bio Control’s current model of Bio Control Device;

(v) draft marketing material (posters, procedure video, etc.);

(vi) lists of third party software used by Bio Control;

(vii) all of Bio Control’s preclinical and clinical data, including animal studies, and human clinical data, descriptions of protocols, adverse event reports, study reports and database copies (in printed or electronic format), as well as a list of investigational sites and principal investigators;

(viii) all regulatory documents, including submissions, registrations and licenses;

(ix) all Software, including Source Code; and

(x) all invention records created by internal and external personnel not otherwise included in the Purchased Assets, as defined in the Asset Purchase Agreement.

(w) “Valid and Enforceable Claim” with respect to any patent claim means an issued claim that has not expired or been rendered invalid or unenforceable by a court of competent jurisdiction or other Governmental Authority from which no appeal can be taken.

(y) “Patents” means the AMS Patents or the Bio Control Patents, as the case may be.

2. License; Information Access.

(a) Bio Control License Grant. Bio Control hereby grants to AMS and its Affiliates an exclusive (excluding inter alia BioControl), worldwide, irrevocable (except as provided in Section 4 below) fully transferable and assignable, right and license (including the right to grant sublicenses), under the Intellectual Property Rights Licensed to AMS, solely within the AMS Field of Use, to develop, design, modify, improve, make, have made, use, import, offer to sell and sell Licensed Products of AMS. AMS hereby acknowledges that Bio Control is the sole and exclusive owner of all right, title and interest in and to the Intellectual Property Rights Licensed to AMS. Except as set forth in this Agreement, AMS shall not have any right, title or interest in or to the Intellectual Property Rights Licensed to AMS. AMS’ license to the Source Code and Software includes the right to use, modify, sublicense, and create derivative works of the Source Code and Software.

(b) AMS License Grant. AMS hereby grants to Bio Control and its Affiliates an exclusive (excluding

 


 

inter alia AMS), worldwide, irrevocable, fully transferable and assignable, royalty-free, right and license (including the right to grant sublicenses), under the Intellectual Property Rights Licensed to Bio Control, solely outside the AMS Field of Use, to develop, design, modify, improve, make, have made, use, import, offer to sell and sell Licensed Products of Bio Control. Bio Control hereby acknowledges that AMS is the sole and exclusive owner of all right, title and interest in and to the Intellectual Property Rights Licensed to Bio Control. Except as set forth in this Agreement, Bio Control shall not have any right, title or interest in or to the Intellectual Property Rights Licensed to Bio Control.

(c) Sublicenses and Cross-licenses. Both Licensees may grant sublicenses and cross-licenses under their respective Licensed Intellectual Property Rights and under each Licensee’s name without the prior written consent of, or payment of any consideration to, the respective Licensor. In addition, Licensee may grant sublicenses and cross-licenses under the Licensed Intellectual Property Rights to develop, design, modify, improve, make, have made, use, import, offer to sell and sell the Licensed Products without the prior written consent of Licensor.

(d) Copying and Access; Destruction. Commencing upon execution and delivery of this Agreement and as requested from time to time thereafter, Bio Control will provide AMS with lists and other reasonable details of the data comprising the Urology Business Information, and will provide AMS with access to and, if requested, true and correct copies (at Bio Control’s expense) of such Urology Business Information in such format(s) as AMS may request. Bio Control will provide AMS with at least ninety (90) days prior notice of its intention to destroy or otherwise dispose of any Urology Business Information, during which time AMS may request and Bio Control will provide AMS with access to, copies of, or possession of original versions of, any such information.

(e) Patent Assignment. Concurrently with the execution of this Agreement, Bio Control will assign to AMS the AMS Patents listed on Exhibit B-3 by an assignment in the form attached as Exhibit C. The AMS Patents listed in B-3 do not include the AMS Patents listed in Exhibits B-1 and B-2, which Bio Control has already assigned to AMS prior to the date hereof. Beginning as of the date hereof, AMS will bear all costs associated with the AMS Patents, including costs of prosecution, issuance fees, and maintenance and annuity fees.

3. Royalties; Audits; Expenses.

(a) Percentage Royalty. Commencing upon April 26, 2006, and for a period of ten (10) years thereafter or, if earlier, upon the expiration or termination of this Agreement, AMS shall pay to Bio Control, or its designee, a royalty equal to the percentage of Net Sales set forth below during each of AMS’ fiscal periods set forth below (subject to appropriate adjustment for any subsequent change in AMS’ fiscal year

 

 

 

 

 

Fiscal Period

 

Royalty Rate

2006 through 2009          

 

 

6

%

2010 through 2012

 

 

5

%

2013 through 2016

 

 

4

%

(b) Sublicense Royalty. In addition to the percentage royalty set forth in Section 3(a) above, AMS shall pay or cause its Affiliate to pay royalties to Bio Control based upon Net Sales of any Licensed Product by sublicensees at the same rate set forth in Section 3(a) above; provided, however, no royalties shall be paid in connection with any sublicense granted by AMS pursuant to any exercise of its authority under Section 6(c) in a case of infringement of a patent or other intellectual property right owned by a third party by reason of the use of the Patent Rights in the manufacture, use or sale of the Licensed Products..

(c) Payments. During the royalty period, AMS shall deliver to Bio Control, no later than forty-five (45) days following the end of each fiscal quarter of AMS, a royalty payment for the preceding fiscal quarter, accompanied by a reasonably detailed report, setting forth the royalty calculations for the quarter to which the payment relates.

(d) Books and Records. AMS agrees to keep substantially complete and accurate books of account and records covering all transactions relating to this Agreement. All such books of account and records shall be

 


 

kept available for at least two (2) years after the termination or expiration of this Agreement.

(e) Audit Rights. Bio Control may cause an audit to be made of those books and records of AMS as necessary to review and audit any statements delivered pursuant to Section 3(c) hereof. Such audit shall be conducted only by an independent certified accountant selected by Bio Control and reasonably acceptable to AMS, after prior written notice to AMS and shall be conducted during regular business hours at AMS’ offices and in such a manner so as not to interfere with AMS’ normal business activities. AMS shall permit such accountant, during normal business hours, to have reasonable access to, and to examine and m


 
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