EX-10.30






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
miniaturoTM 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
miniaturoTM 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 miniaturoTM, (F) floor plan and equipment list
for a facility capable of performing the manufacturing steps of the miniaturoTM
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 make copies
of, those books and records of AMS as are necessary to review and audit the calculation in
question. Neither Bio Control nor such accountant will have the right to review or audit
any other books and records of AMS. In no event shall more than one audit be conducted, nor
shall the records supporting any statements be audited more than once for the same purpose.
In the event any such audit reveals any discrepancy less than five percent (5%) of the
applicable Net Sales for any consecutive twelve (12) months, Bio Control shall pay for the
reasonable third party costs and expenses of such audit. In the event any such audit
reveals any discrepancy greater than or equal to five percent (5%) of the applicable Net
Sales for any consecutive twelve (12) months, AMS shall pay for the reasonable third party
costs and expenses of such audit.




(f) Expenses. Unless otherwise specifically set forth herein, all fees, costs and expenses
incurred by a Licensee in developing, manufacturing, promoting, marketing and selling its
Licensed Products or otherwise incurred under this Agreement shall be borne solely by such
Licensee.




4. Term and Termination.




(a) Term. The term of this Agreement shall commence on the Effective Date and shall remain
in force, unless terminated earlier in accordance with Section 4(b), until the last to
expire of the Patent Rights.




(b) Termination. Notwithstanding the provisions of Section 4(a), this Agreement may be
terminated in accordance with the following provisions




(i) AMS may terminate this Agreement immediately if all of the Intellectual Property
Rights Licensed to AMS, including, without limitation, the Bio Control Patent
Rights, have been rendered invalid or unenforceable by a court of competent
jurisdiction or other Governmental Authority from which no appeal can be taken.




(ii) Either party may terminate this Agreement upon an arbitration award (pursuant
to the dispute resolution procedure referenced in Section 9(c)) below, finding that
the other party is in material breach of this Agreement and the breaching party’s
failure to comply with the terms of such order (including payment of damages) within
ninety (90) days after entry of the award.




(c) Rights and Obligation on Termination. In the event of termination or expiration of this
Agreement for any reason, the parties shall have the following rights and obligations:




(i) AMS shall remain responsible for any payment due to Bio Control that has accrued
prior to the effective date of such termination or expiration, except if all of the
Bio Control Patent Rights have been held to be invalid, in which case no payments
shall be owed.




(ii) The licenses granted to the Licensees under Sections 2(a) and 2(b) above shall
immediately terminate and be of no further force and effect; provided, however, that
if this Agreement expires by its terms in accordance with Section 4(a), the licenses
granted to Licensees under Sections 2(a) and 2(b) shall continue indefinitely with
respect to all Licensed Intellectual Property Rights except the Patent Rights.




(iii) Sections 4(c), 7, 8 and 9 shall survive any termination or expiration of this
Agreement. In addition, Section 3(e) shall survive for a period of two (2) years
from the date of termination or expiration of this Agreement




(iv) Licensee, its Affiliates and any sublicensees shall be permitted to sell any
inventory of the Licensed Products on hand at the effective date of such termination
or expiration, provided that no provision of this Agreement shall prevent Licensee,
its Affiliates or sublicensees from selling the



 









 







Licensed Products after termination or expiration of this Agreement if the relevant
Patent Rights have expired.




5. Option to File Continuing Applications. Each party (the “Filing Party”) shall have the
right to file U.S. patent applications (“Other Party Applications”) claiming priority from
one or more of the Patents assigned to or under an obligation to be assigned to the other
party (the “Other Party”), subject to the following terms and conditions: (i) the Filing
Party shall (a) bear all costs associated with the filing and prosecution of the Other Party
Application and the issuance and maintenance of any patent that issues therefrom; (b) be
responsible for the prosecution of the Other Party Application; (c) keep the Other Party
apprised of all proceedings concerning prosecution of the Other Party Application before the
US Patent and Trademark Office (the “USPTO”) by electronic access or by providing copies of
correspondence and official actions within ten (10) days of receipt thereof from the USPTO;
by providing the Other Party copies of all correspondence, filings and responses to official
actions at least thirty (30) days in advance of the deadline for any such filing with the
USPTO; and by providing the Other Party with an opportunity to comment; and (d) consult with
the Other Party before carrying out any filing in the USPTO with respect to the Other Party
Application; (ii) the Other Party shall have the right to object to the future filing of any
Other Party Application, or to the carrying out of any filing in the USPTO, in whole or in
part, with respect to an Other Party Application that the Other Party reasonably believes
may adversely affect the Other Party’s rights in any other applications or patents assigned
to or under an obligation to be assigned to the Other Party and the party proposing to file
the Other Party Application shall refrain filing the proposed Other Party Application upon
any such objection by the Other Party ; (iii) the Other Party Application shall be assigned
to the Other Party, and any patent that issues from the Other Party Application shall remain
assigned to the Other Party; and (iv) this right to file Other Party Applications shall not
be applicable if the number of continuing applications that may be filed is limited by US
law or USPTO rules. Notwithstanding subsection (iv) above, if the number of continuing
applications or Requests for Continued Examination (“RCEs”) that may be filed is limited by
US law or USPTO rules, AMS shall have the right, subject to subsections (i)-(iii) above, to
file half of the maximum permitted number of continuing applications claiming priority from
US Application 10/538,521, and half of the maximum permitted number of RCEs available to US
Application 10/538,521 and its continuing applications, with any fractional number of
continuing applications or RCEs being rounded down to next lower integer, including zero if
applicable. The parties agree that US Application 11/932,579 [docket numbers STC 63142 and
A92.12-0039], filed October 31, 2007, shall be an Other Party Application.




6. Patent Prosecution and Infringement.




(a) Licensed Rights. With respect to the Patent Rights only, each Licensor shall (i) pay
when due all maintenance and annuity fees for its respective Patent Rights; (ii) be
responsible for the prosecution of its respective Patent Rights before the applicable
examining authority; (iii) consult with Licensee regarding in which foreign countries
Licensee desires patent protection; and (iv) keep Licensee apprised of all proceedings
concerning prosecution of the Licensor’s Patent Rights before the applicable examining
authority by electronic access or by providing copies of correspondence and official actions
within ten (10) days of receipt thereof from any such examining authority; by providing
Licensee copies of all correspondence, filings and responses to official actions at least
thirty (30) days in advance of the deadline for any such filing with such authorities; and
by providing Licensee with an opportunity to comment. If Licensee’s comments are related to
arguments made to advance prosecution of any claim related to the AMS Field of Use, in the
case of AMS, or outside the AMS Field of Use, in the case of Bio Control, Licensor shall not
unreasonably refuse to take into account such input in its response to the official action.
If Licensor (i) elects not to prosecute; (ii) desires to abandon any patent applications
included in the definition of the Licensed Intellectual Property Rights; (iii) desires not
to maintain any patent or patent application included in the definition of Patent Rights; or
(iv) does not desire to file a patent application in any foreign country in which Licensee
has expressed an interest, it shall so notify Licensee in writing allowing sufficient time
for Licensee to (w) assume the prosecution of any such patent application prior to any
abandonment thereof; (x) prevent any actual abandonment of any patent or patent application;
(y) make maintenance and annuity fee payments in advance of any abandonment thereof; and (z)
file patent applications in foreign countries of Licensee’s choice. Licensor shall assign
its rights to Licensee in any such patent or patent application filed outside of the US, and
Licensee shall have the right to prosecute and



 









 







maintain such patent or patent application in its own name at its own expense. Any such
patent or patent application filed in the US shall remain assigned to Licensor, who will
cooperate at Licensee’s expense and at Licensee’s complete discretion with the prosecution
and maintenance of such patent. Licensee’s complete discretion shall be subject to the
following obligations: (i) to keep the Licensor apprised of all proceedings concerning
prosecution of the Other Party Application before the US Patent and Trademark Office (the
“USPTO”) by electronic access or by providing copies of correspondence and official actions
within ten (10) days of receipt thereof from the USPTO; by providing the Other Party copies
of all correspondence, filings and responses to official actions at least thirty (30) days
in advance of the deadline for any such filing with the USPTO; and by providing the Other
Party with an opportunity to comment; and to take into account any objections of the
Licensor to actions which Licensor reasonably believes may adversely affect the Licensor’s
rights in any other applications or patents assigned to or under an obligation to be
assigned to the Licensor. Licensee will have an exclusive, irrevocable, fully paid up,
license to exploit such patent or patent application in the country in which the application
or patent was filed in the AMS Field of Use, in the case of AMS, or outside the AMS Field of
Use, in the case of Bio Control, with the full right to sublicense. Licensee and Licensor
shall cooperate fully with each other to execute all necessary documentation to enable each
party to perform its duties and exercise its rights under the terms of this Section 6(a).
All out of pocket costs to Licensor arising out of fulfillment of a specific, written
request of Licensee pursuant to this subsection shall be borne by Licensee, so long as
Licensee has approved such expenses in advance.




(b) Infringement.




(i) With respect to the Patent Rights only, when information comes to the attention
of Licensor or Licensee to the effect that any of the Patent Rights have been or are
threatened to be infringed by a third party, Licensor or Licensee, as the case may
be, shall notify the other party in writing of any such infringement or threatened
infringement of which it becomes aware. If such infringement or threatened
infringement relates to any Patent Rights within the AMS Field of Use, in the case
of AMS, or outside the AMS Field of Use, in the case of Bio Control, Bio Control or
AMS, as the case may be, shall have the initial right but not the obligation to take
action to stop such infringement or otherwise enforce its rights. In the event Bio
Control or AMS, as the case may be, takes no action to stop such infringement within
ninety (90) days of notifying the other partying in writing of the infringement or
threatened infringement or within ninety (90) days of it otherwise becoming aware of
such infringement, Bio Control, as Licensor, or AMS, as Licensor, shall have the
right to commence an action against such infringement, at its own expense and in its
own name. The party controlling any such action is referred to below as the
“Controlling Party” and the other party, with respect to such action, as the
“Cooperating Party.”




(ii) The Cooperating Party shall cooperate with the Controlling Party in any action,
suit or proceeding brought under Section 6(b)(i). If a Controlling Party determines
that it is necessary or desirable for a Cooperating Party to join any such suit,
action or proceeding, the Cooperating Party shall, at the Controlling Party’s
expense, execute all documents and perform such other acts as may be reasonably
required. If the Controlling Party initiates suit hereunder it shall have the
exclusive right to employ counsel of its own selection and to direct and control the
litigation or any settlement thereof (subject to the penultimate sentence hereof),
shall pay all of the Cooperating Party’s reasonable, out of pocket costs, if any,
promptly upon the Controlling Party’s receipt of a request for reimbursement
(accompanied by sufficient supporting documentation). Subject to such reimbursement
of the Cooperating Party’s reasonable, out-of-pocket expenses, the Controlling Party
shall be entitled to reimburse itself out of any sums recovered in such suit or in
settlement thereof for all costs and expenses, including reasonable attorneys’ fees,
necessarily involved in the prosecution of such suit, and any funds that shall
remain from said recovery shall be used to reimburse the Cooperating Party for all
of its other reasonable costs and expenses, in addition to the out-of-pocket costs
already reimbursed, necessarily involved in its participation in such suit, and any
balance remaining thereafter shall be distributed to the Controlling Party subject,
in the case of a Licensee as Controlling Party, to the royalty obligations herein.
In any such action, the Cooperating Party shall, at it own expense, have the right
to non-controlling participation through counsel of its own selection. If the
Controlling Party desires to settle such claim or suit, it shall first give the
Cooperating Party written notice of the terms of the proposed



 









 







settlement and the Cooperating Party shall have the right to approve or reject such
proposal. The failure of the Cooperating Party to respond in writing to a notice of
settlement within fifteen (15) business days following the giving of such notice by
the Controlling Party shall automatically constitute an approval of the terms of the
proposed settlement contained therein.




(c) Action Against Licensee. At the request of Licensee, Licensor will cooperate with
Licensee in the defense of any suit, action or proceeding against Licensee, or any Affiliate
or sublicensee of Licensee, alleging the infringement of a patent or other intellectual
property right in the manufacture, use or sale of the Licensed Products. Licensee shall
give Licensor prompt notice of the commencement of any such suit, action or proceeding or
claim of infringement and shall furnish to Licensor a copy of each communication relating to
the alleged infringement. Licensor hereby grants to Licensee the right to exclusive control
of the defense of any such suit, action or proceeding and the exclusive right to compromise,
litigate, settle or otherwise dispose of any such suit, action or proceeding and shall
provide all information and assistance necessary to defend or settle any such suit, action
or proceeding. Licensee shall have the right to join Licensor as a defendant, if necessary
or desirable, and Licensor shall join in any such action and shall execute all documents and
take all other actions, including giving testimony, which may reasonably be required in
connection with the defense of such suit, action or proceeding. Each party shall have the
right to be represented by counsel of its own selection, at its own expense, in the defense
of any suit under this Section 6(c). Notwithstanding the foregoing, Bio Control’s sole and
exclusive financial obligations arising out of any claim for infringement of any third party
Intellectual Property rights are set forth in the Indemnification provisions of Section 5.6
of the Asset Purchase Agreement, and AMS shall have no financial obligations to Bio Control
arising out of any claim for infringement of any third party Intellectual Property rights
under the AMS Patent Rights.




7. Confidentiality. Bio Control and AMS agree that Section 4.1 (“Confidentiality”) of the
Asset Purchase Agreement is incorporated by reference herein and shall apply to all
information disclosed in the performance of this Agreement, provided that, in addition to
the respective rights to use, and restrictions on each party’s use of, the Urology Business
Information pursuant to the exclusive licenses granted in Sections 2(a) and 2(b), above:




(a) AMS will treat the Urology Business Information as the Confidential Information of Bio
Control outside of the AMS Field of Use, and, subject to the exceptions and exclusions in
Section 4.1(c) of the Asset Purchase Agreement, will not disclose the Urology Business
Information for any purpose outside of the AMS Field of Use or to any Person for the use, or
intended use, by such Person outside of the AMS Field of Use;




     (b) AMS will treat the Urology Business Information as the Confidential Information of
Bio Control within the AMS Field of Use, and, subject to the exceptions and exclusions in
Section 4.1(c) of the Asset Purchase Agreement, will not disclose the Urology Business
Information for any purpose within the AMS Field of Use or to any Person for the use, or
intended use, by such Person within of the AMS Field of Use; and




     (c) Each party will treat the Urology Business Information as confidential and
proprietary, and will protect the Urology Business Information from disclosure using same
degree of care that it uses to protect its other, similar confidential and proprietary
information (but in any event no less than commercially reasonable care, including requiring
execution and delivery of appropriate confidentiality and non-disclosure agreements prior to
any permitted disclosure).




8. Additional Grant. Bio Control and AMS hereby agree to disclose to each other, the filing
of any and all patent applications (including all patents issuing on such applications)
covering electrical stimulation technology during a period from April 26, 2006, through
April 26, 2009, subject to renewal for successive two (2) year terms thereafter, to the
extent mutually agreed in writing by the parties prior to the end of the initial term or any
renewal term, as the case may be. Bio Control and AMS agree that each will use good faith
and commercially reasonable efforts (including after such period) to negotiate and enter
into one or more non-exclusive license agreements with one another for all patent
applications disclosed during the period, (i) granting AMS rights to any such patent
applications filed by Bio Control during such period within the AMS Field of Use; and (ii)
granting Bio Control rights to any such patent applications filed by AMS during such period
outside of the AMS Field of Use. In all cases, such license agreements will



 









 







provide for royalty payments at a rate that is commercially reasonable, commensurate with
the value accorded by the parties, but not to exceed six percent (6%). Either party may
terminate the parties’ obligations to disclose patent applications and to negotiate or to
continue any ongoing negotiations under this Section 8 by notice to the other party
following a Change in Control (as defined in the Asset Purchase Agreement) of either party,
provided that such notice is given within thirty (30) days following the effective date of:
(i) the Change in Control, if the termination notice is given by the party undergoing the
Change in Control; or (ii) notice of the Change in Control given pursuant to the following
sentence, if the termination notice is given by the party not undergoing the Change in
Control. Each party covenants and agrees to provide the other with notice of any Change in
Control no later than two (2) business days following the effective date of the Change in
Control.




9. Miscellaneous.




(a) Assignment; Change in Control. Neither party may assign or otherwise transfer its
rights and obligations under this Agreement without the prior written consent of the other
party, except to an Affiliate or any successor in interest of all or substantially all of
the business of such party, whether by merger, operation of law, assignment, purchase or
otherwise, and except that a Licensee may grant any sublicenses in accordance with Section
2(c). Any prohibited assignment shall be null and void. All terms and conditions of this
Agreement shall be binding on and inure to the benefit of the successors and permitted
assigns of the parties. Notwithstanding the foregoing, this Agreement shall not be
assignable upon a Change in Control of Bio Control (by operation of law or otherwise) unless
the party(ies) acquiring control execute and deliver, and upon any Change in Control Bio
Control shall cause such parties to execute and deliver, an agreement, in the form attached
as Exhibit D, acknowledging AMS’ exclusive license hereunder, including AMS’ rights in the
Urology Business Information.




(b) Relationship. This Agreement shall not constitute either party as the legal
representative, partner, joint venturer or agent of the other party hereto, nor shall either
party have the right or authority to assume, create, or incur any liability or any
obligation of any kind, express or implied, against or in the name of or on behalf of the
other party hereto.




(c) Dispute Resolution. The parties agree that all disputes, of whatever nature, arising
hereunder shall be finally settled pursuant to Article 6 of the Asset Purchase Agreement.




(d) Entire Agreement; Waiver and Release. This Agreement constitutes the entire agreement
between the parties hereto relative to the subject matter hereof, and supersedes any and all
prior agreements, written or oral, between the parties relating to such subject matter
including but not limited to the License Agreement and the Memorandum of Understanding.




(e) Amendments. No modifications or amendments of any of the terms hereof shall be valid or
binding unless made in writing and signed by Bio Control and AMS.




(f) Waiver. No waiver of any breach of any provision of this Agreement shall constitute a
waiver of any prior, concurrent or subsequent breach of the same or any other provision
hereof, and no waiver shall be effective unless made in writing.




(g) Notices. All notices, requests, demands, claims and other communications hereunder
shall be in writing. Any notice, request, demand, claim, or other communication hereunder
shall be deemed duly given (a) if personally delivered, when so delivered, (b) if given by
facsimile, once such notice or other communication is transmitted to the facsimile number
specified below and electronic confirmation is received; or (c) if sent through an overnight
delivery service in circumstances to which such service guarantees second day international
delivery, the second day following being so sent:




If to Bio Control:




			
	                    To:	 	Bio Control Medical (B.C.M), Ltd.

3 Geron St.

Yehud 56100

Israel

Attn: Chief Executive Officer

Fax: +972-3-6322125





 









 









With a copy to:


Sanford T. Colb & Co.

P.O.B. 2273,

Rehovot, Israel

Attn: Sanford T. Colb, Esq.

Fax: +972 8 9 454556





If to AMS:




			
	                    To:	 	American Medical Systems, Inc.

10700 Bren Road West

Minnetonka, Minnesota 55343

Attn: Chief Executive Officer
Fax: (612) 930-6695




With a copy to:

Oppenheimer Wolff & Donnelly LLP

3300 Plaza VII

45 South Seventh Street

Minneapolis, Minnesota 55402

Attn: Thomas A. Letscher, Esq.

Fax: (612) 607-7100





Any party may give any notice, request, demand, claim or other communication hereunder using
any other means (including ordinary mail or electronic mail), but no such notice, request,
demand, claim or other communication shall be deemed to have been duly given unless and
until it actually is received by the individual for whom it is intended. Any party may
change the address to which notices, requests, demands, claims and other communications
hereunder are to be delivered by giving the other parties notice in the manner herein set
forth.




(h) Severability. If any provision of this Agreement shall be held invalid or unenforceable
by any court of competent jurisdiction, the remaining provisions of this Agreement shall
remain in full force and effect. Further, should any provision of this Agreement be deemed
unenforceable by virtue of its scope, such provision shall be deemed limited to the extent
necessary to render the same enforceable.




(i) Governing Law. This Agreement shall be governed by, construed and enforced in
accordance with the laws of the State of New York (regardless of the laws that might
otherwise govern under applicable principles of conflicts of law).




(j) Headings. The headings of sections and subsections of this Agreement have been inserted
for the convenience of reference only and shall in no way restrict or otherwise modify the
terms of this Agreement.




(k) Counterparts. This Agreement may be signed in any number of counterparts and the
signatures delivered by facsimile, each of which shall be an original, with the same effect
as if the signatures thereto and hereto were upon the same instrument. This Agreement shall
become effective when each party hereto shall have received a counterpart hereof signed by
the other parties hereto.



[Remainder of Page Intentionally Left Blank]




 









 








     IN WITNESS WHEREOF, the parties hereto have executed this Amended and Restated License
Agreement effective as of the Effective Date.



	 	 	 	 	 
	 	BIO CONTROL MEDICAL (B.C.M), LTD.

 	 
	 	By:  	/s/   Ruth Alon
 	 
	 	 	Name:  	Ruth Alon 	 
	 	 	Title:  	Director 	 
	 
	 	 	 
	 	By:  	/s/  Yosef Gross
 	 
	 	 	Name:  	Yosef Gross 	 
	 	 	Title:  	Director 	 
	 
	 	AMERICAN MEDICAL SYSTEMS, INC.

 	 
	 	By:  	/s/  John F. Nealon
 	 
	 	 	Name:  	John F. Nealon 	 
	 	 	Title:  	Senior Vice President, Business Development 	 
	 



SIGNATURE PAGE

LICENSE AGREEMENT