Document:

EXHIBIT 10.2 

CERTAIN INFORMATION
INDICATED BY [ * * * ] HAS BEEN DELETED FROM THIS EXHIBIT AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24b-2. 

TRANSITION SERVICES AND SUPPLY AGREEMENT

          This
Transition Services and Supply Agreement (this “Agreement”) is made and entered
as of September 6, 2011 (the “Effective Date”), by and between, Medtronic,
Inc., a Minnesota corporation (“Licensor”), and Urologix Inc., a Minnesota corporation
(“Licensee”; Licensor and Licensee being sometimes individually referred to as
a “Party” and collectively as the “Parties”). 

          WHEREAS,
Licensor and Licensee entered into that certain License Agreement of even date
herewith (the “License Agreement”) pursuant to which Licensor, among other
things, granted to Licensee an exclusive license under Licensor’s intellectual
property relating to Licensor’s minimally-invasive radio-frequency treatment
for symptomatic benign prostatic hyperplasia (“BPH”) (the “Prostiva RF Therapy
System”) in the field of radio frequency treatment of the prostate, including
without limitation, the treatment of BPH; 

          WHEREAS,
prior to the Effective Date, Licensor was in the business of developing,
manufacturing, marketing, selling and distributing components for the Prostiva
RF Therapy System (the “Prostiva Business”), and after the Effective Date,
Licensee wishes to manufacture, market, sell and distribute the Prostiva RF
Therapy System, but in order to do so requires certain transition services from
Licensor; and 

          WHEREAS,
Licensee will act as Licensor’s interim distributor of the products and
components identified on Exhibit E to the License Agreement (the
“Products”) pursuant to the terms and conditions set forth on Schedule B hereto
(the “Interim Distribution Agreement”); and 

          WHEREAS,
to allow Licensee an opportunity to reach agreement with Licensor’s suppliers
regarding direct supply of the Products, and to facilitate Licensee’s marketing
and sale of the Products, the Parties deem it necessary and appropriate for
Licensor to consign to Licensee certain finished goods inventory, and, if
necessary, for Licensor to order and purchase certain products from certain
suppliers of Licensor on Licensee’s behalf, all of the foregoing in accordance
with the terms and conditions of this Agreement; and 

          WHEREAS,
in order to assist Licensee with the orderly transition of the Prostiva
Business, Licensor agrees to provide certain transition services, and Licensee
agrees to receive such services pursuant to the terms and conditions set forth
in this Agreement. 

          NOW,
THEREFORE, in consideration of the representations, warranties, covenants and
agreements contained herein, and for other valuable consideration, the receipt
and adequacy of which is hereby acknowledged, the parties mutually agree as
follows: 

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ARTICLE 1
DEFINITIONS

          1.1          Defined Terms. Capitalized terms contained herein but not
otherwise defined herein shall have the meanings ascribed them in the License
Agreement. Other terms defined in the text of this Agreement shall have the
following meanings or the meanings ascribed to them in body of this Agreement: 

          (a)          “Applicable
Law” shall mean the applicable laws, rules, regulations, including but not
limited to any guidelines or other requirements of any Regulatory Authority in
the relevant country, and industry guidelines or codes of conduct, that may
apply to the review and analysis of safety reports, the communication of safety
reports to Regulatory Authorities and the maintenance of records relating to
safety reports of the Products. 

          (b)          “Licensee
Awareness Date” shall mean the date on which Licensee Becomes Aware of a
reportable event. 

          (c)          “Licensor
Awareness Date” shall mean the date on which Licensor Becomes Aware of a
reportable event. 

          (d)          “Licensee
Becomes Aware” shall mean that a Licensee employee has acquired information
that reasonably suggests that a Product-related event has occurred. 

          (e)          “Licensor
Becomes Aware” shall mean that a Licensor employee has acquired information
that reasonably suggests that a Product-related event has occurred. 

          (f)          “Regulatory
Authority” shall mean any applicable federal, national, regional, state,
provincial or local regulatory agencies, departments, bureaus, commissions,
councils or other government entities regulating or otherwise exercising
authority with respect to the Products in the relevant country. 

          (g)          “Regulatory
Transfer” shall mean, for the United States, the US Regulatory Transfer;
for countries of the European Union, the EU Regulatory Transfer; and for the
rest of the world, the OUS/OEU Regulatory Transfer. Unless otherwise
specifically noted, references to the “Regulatory Transfer” herein are intended
to cover any of the foregoing. 

          (h)          “Product
Complaint” shall mean any written, electronic, or oral communication that
alleges deficiencies related to the identity, quality, durability, reliability,
safety, effectiveness, or performance of a medical device that has been placed
on the market. 

          (i)          “Valid
Report” means a complaint entry form approved by Licensor for purposes of
expedited reporting to Regulatory Authorities. 

          1.2          Other Definitional Provisions. 

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          (a)          The
words “hereof,” “herein,” and “hereunder” and words of similar import, when
used in this Agreement, shall refer to this Agreement as a whole and not to any
particular provisions of this Agreement. 

          (b)          The
terms defined in the singular shall have a comparable meaning when used in the
plural, and vice versa. 

          (c)          References
to a “schedule” are, unless otherwise specified, to one of the schedules
attached to or referenced in this Agreement, and references to an “Article” or
a “Section” are, unless otherwise specified, to one of the Articles or Sections
of this Agreement. 

          (d)          The
term “person” includes any individual, partnership, joint venture, corporation,
trust, unincorporated organization or government or any department or agency
thereof. 

          (e)          The
word “including” or any variation thereof means (unless the context of its
usage otherwise requires) “including, without limitation” and shall not be
construed to limit any general statement that it follows to the specific or
similar items or matters immediately following it. 

          (f)          All
references to time shall refer to Minneapolis, Minnesota time. 

ARTICLE 2

TRANSITION SERVICES

          2.1          Costs and Responsibilities. Each of Licensor and Licensee shall, from
and after the Effective Date assume those responsibilities and related costs
assigned to it as specifically provided in (a) this Agreement, including
without limitation, as set forth in the Transition Services Plan attached as Schedule
A (the “Transition Plan”), the Interim Distribution Agreement attached as Schedule
B, the Regulatory Transition Plan attached as Schedule C, and the
Quality Agreement attached as Schedule D) (b) the License Agreement, (c)
the Acquisition Option Agreement, and (d) the Asset Purchase Agreement, all in
accordance with the terms and conditions set forth herein and therein, for the
manufacturing, sourcing, operation, regulatory compliance, and quality
requirements of the Prostiva Business. 

          2.2          Transition Responsibilities. 

          (a)          Transition Services During Initial Term. 

	
  

 	
  

 
	
  

 	
           (i)          Licensor
 shall, with Licensee’s good faith cooperation, provide those transition
 services as specifically set forth in this Agreement and the applicable
 Schedules hereto (“Transition Services”) in accordance with Applicable Laws
 and in the manner and for the periods of time described therein. 

 
	
  

 	
  

 
	
  

 	
           (ii)          Licensor
 shall provide such Transition Services until the date that is one (1) month
 following the date that Licensor completes the 510(k) Work, as defined in
 Section 4.1 hereof (the foregoing period shall be hereinafter referred to

 

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 as
 the “Initial Term”). Notwithstanding the foregoing, if Licensee has not
 obtained the necessary regulatory clearances and permits to sell the Products
 in the United States under Licensee’s own quality system and labeling (“US
 Regulatory Transfer”) by the earlier of (i) April 30, 2012, or (ii) the date
 that is six (6) months following Licensor’s initial submission of the 510(k)
 Notification referred to in Section 4.1(a) hereof, a “Major Challenge” (as
 defined below) shall be deemed to have occurred under Section 4.1(d) below.

 
	
  

 	
  

 
	
  

 	
           (iii)          The
 Transition Plan may be revised from time to time upon the mutual written
 agreement of Licensor and Licensee. Licensee acknowledges that Licensor’s
 ability to perform the Transition Services depends in part on Licensee’s full
 and timely performance and cooperation, and as such, Licensee agrees to
 fulfill its responsibilities and obligations with respect to the Transition
 Plan, to comply with Applicable Laws, and to cooperate in good faith with
 Licensor in the provision of Transition Services hereunder.

 
	
  

 	
  

 
	
  

 	
           (iv)          Licensee
 shall pay Licensor a fee of $30,000 per month (the “Monthly Fee”) beginning
 in the second month following the Effective Date for the performance of
 Transition Services for each month until the earlier of (x) the expiration of
 the Initial Term or (y) one month following the last of the US Regulatory Transfer
 or the EU Regulatory Transfer.

 
	
  

 	
  

 
	
  

 	
           (v)          Further,
 in the event that Licensor is required to pay a Person (other than Licensor,
 its Affiliates, or contracted employees) to perform required Transition
 Services that are not anticipated by the Transition Plan, not related to the
 510(k) Work, or not due to Licensor’s failure to perform under this or any of
 the Transaction Documents (“Third Party Costs”), Licensor shall consult with
 Licensee to explore cost-savings measures with regard to those Third Party
 Costs. Following such consultation and incurring of such Third Party Costs,
 Licensor shall provide Licensee reasonable evidence of the Third Party Costs
 associated therewith. Licensor shall invoice Licensee for the foregoing
 Monthly Fees and Third Party Costs on a monthly basis, and Licensee shall pay
 each such invoice within thirty (30) days following the date thereof.
 Licensee shall reimburse Licensor for Third Party Costs up to an aggregate
 maximum of [ * * * ] during the Initial Term. If and once Third Party Costs
 have exceeded [ * * * ] during the Initial Term, Licensee shall have the
 option to terminate this Agreement pursuant to Section 9.2(c) hereof in lieu
 of incurring further Third Party Costs. In the event of such a termination,
 Licensor shall promptly refund to Licensee an amount equal to $250,000 (the
 “Excessive Third Party Costs Refund”). Such a termination of the Agreement
 will not release Licensor or Licensee from any obligation that accrued prior
 to the effective date of such termination, but such a termination will
 release Licensee of any further payment obligation for any Minimum Royalty
 for a partial Contract Year except as set forth in Section 9.2(d) hereof, any
 License Fee not then due and payable, and any obligation to purchase
 Transferred Prostiva Assets under the Acquisition Option Agreement or to 

 

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 purchase
 Assets under the Asset Purchase Agreement. As further described in Section
 9.2(c) hereof, the Excessive Third Party Costs Refund and the foregoing
 termination right shall be the sole remedy available to Licensee for
 excessive Third Party Costs described herein, and neither party shall have
 any liability to other party or shall suffer any consequences as a result of
 Licensee’s termination pursuant to this Section, except as explicitly set
 forth in this Section 2.2(a)(v) or Section 9.2(c) hereof. 

 

	
  

 	
  

 	
  

 
	
  

 	
 (b)       Services After Initial Term. Licensee
 may ask Licensor to provide Licensee with additional services following the
 expiration of the Initial Term, in which case Licensor may agree to do so, as
 determined in Licensor’s discretion, at a fee equal to $200 per hour. 

 

          2.3          Taxes. Prices and charges on the Transition Plan, or as otherwise agreed to
pursuant to Section 2.2 hereof, do not include any applicable sales, use, value
added or similar taxes, customs, duties, or tariffs imposed by any governmental
authority. 

          2.4          Document Delivery.   Subject to the terms and
conditions of this Agreement, during the Initial Term, Licensor shall provide
Licensee (i) copies of design specifications, drawings, bills of material,
engineering and documentation used in connection with the Prostiva Business as
contemplated in the Transition Plan, and (ii) sales and promotional literature,
artwork, other sales and marketing materials, and customer lists used in
connection with the Prostiva Business, as such materials are described in
Exhibit C of the License Agreement. 

          2.5          Employees.   On or promptly after the Effective Date, Licensee
shall offer to employ all eight (8) employees listed on Schedule 2.5 (the
“Designated Employees”) with compensation structures substantially similar to
those in existence on the Effective Date as well as substantially similar job
duties and responsibilities. Licensee shall also give each Designated Employee
who accepts employment with Licensee full credit for all years of service
accrued by such employee as of the Effective Date, subject to the terms of
Licensee’s benefit plans and policies. Licensor shall assist Licensee in its
efforts to hire the Designated Employees, but cannot guarantee their hiring.
Further, none of Licensor, its Affiliates, nor VidaMed may solicit employment
with the Designated Employees for a period of six (6) months from the Effective
Date. 

ARTICLE 3

SALE OF PRODUCTS 

          3.1          Exclusive Distributor of Products in the
United States. As of the
Effective Date, Licensor hereby appoints, and Licensee hereby agrees to act as
Licensor’s exclusive United States (excluding Puerto Rico) distributor of the
Products in compliance with the terms and conditions of the Interim
Distribution Agreement set forth in Schedule B. Licensee will operate as
Licensor’s exclusive interim distributor of the Products in the United States
(excluding Puerto Rico), and will be permitted to sell such products under
Licensor’s regulatory approvals and clearances until the date of US Regulatory
Transfer. For the avoidance of doubt, any alleged 

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breach
by Licensee of the terms and conditions of the Interim Distribution Agreement
shall be subject to the provisions of this Agreement. 

   3.2          
Sale of Products Outside of the United States. 

                   (a)
European Union. 

	
  

 	
  

 	
  

 
	
  

 	
  

 	
      (i)          After
 the Effective Date, Licensor shall continue to sell Products in the European
 Union (EU) either directly or through its distribution network until the date
 that is three (3) months following the Effective Date hereof (the “Licensor
 EU Transition Period”); provided, however,
 that in the event Licensor is unable able to orderly dissolve or terminate
 its distribution arrangement in a given territory of the EU so as to minimize
 its financial loss related thereto during the Licensor EU Transition Period,
 Licensor shall provide Licensee with notice thereof and of a reasonable
 extension of the Licensor EU Transition Period with respect to any such
 territory. If, during the Licensor EU Transition Period, as extended (if
 applicable), Licensor sells more than 300 handpieces in the European Union,
 Licensor will provide Licensee with a credit toward the second License Fee
 payment referred to in Section 3.1 of the License Agreement equal to fifty
 percent (50%) of the gross profit on those units sold in excess of 300, which
 gross profit shall be calculated by subtracting the transfer price of each
 such Product as set forth in Schedule 5.5 hereof, from the net sales amount
 of each such Product. 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
      (ii)          After
 the Licensor EU Transition Period has expired, as determined on a
 territory-by-territory basis, Licensee shall be entitled to distribute the
 Products in each such territory on an exclusive basis pursuant to the terms
 and conditions set forth in the Interim Distribution Agreement set forth in
 Schedule B until the earlier of (1) the time that Licensee obtains the
 necessary regulatory approvals and permits to sell the Products in the
 European Union under Licensee’s own quality system and labeling in accordance
 with the Transition Plan and Regulatory Transition Plan described below (“EU
 Regulatory Transfer”), or (ii) April 30, 2012 (the “Licensee EU Transition
 Period”). After the Licensee EU Transition Period has expired, Licensee shall
 be free to sell Products in the EU, subject to receipt of necessary
 regulatory approvals and permits. 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
 (b)
 Outside of the US and the EU.

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           (i)     After
 the Effective Date, Licensor shall continue to sell Products outside of the
 United States and the EU either directly or through its distribution network
 until the date that is three (3) months following the Effective Date hereof
 (the “Licensor OUS / OEU Transition Period”); provided, however, that in the event Licensor is unable to
 orderly dissolve or terminate its distribution arrangement in a given
 territory so as to minimize its financial loss related thereto during the
 Licensor OUS / OEU Transition Period, Licensor shall provide Licensee with
 notice thereof and of a reasonable extension of the Licensor EU

 

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 Transition
 Period with respect to any such territory. Licensor shall not be obligated to
 make any payments to Licensee as a result of, and Licensee will have no
 obligation to provide any Product or support for, Licensor’s sales during the
 Licensor OUS / OEU Transition Period.

 
	
  

 	
  

 
	
  

 	
      (ii)          After
 the Licensor OUS / OEU Transition Period has expired, as determined on a
 country-by-country basis, Licensee shall be entitled to distribute the
 Products in each such country on an exclusive basis pursuant to the terms and
 conditions set forth in that Interim Distribution Agreement set forth in
 Schedule B until the earlier of (1) the time that Licensee obtains the
 necessary regulatory approvals, clearances and permits to sell the Products
 in each such territory under Licensee’s own quality system and labeling in
 accordance with the Transition Plan and Regulatory Transition Plan described
 below (“OUS / OEU Regulatory Transfer”), or (2) the date that is one (1)
 month following the date of EU Regulatory Transfer (the “Licensee OUS/ OEU
 Transition Period”). After the Licensee OUS / OEU Transition Period has
 expired with respect to a territory outside of the EU or the United States,
 Licensee shall be free to sell Products in such territory subject to receipt
 of necessary regulatory approvals, clearances and permits. 

 

3.3     Product Warranties. 

	
  

 	
  

 
	
                        (a)     Repair and Service of Damaged Products.

 
	
  

 	
  

 
	
  

 	
           (i)          Financial Responsibility for Repairs and Services. With
 respect to Products sold by Licensor prior to, on or after the Effective Date
 in accordance with Sections 3.1 or 3.2 above, which are under written
 warranty, Licensor agrees to be financially responsible for the actual costs
 related to repair and service of such Products, and in accordance with,
 Licensor’s written warranties to the extent such costs are not reimbursed by
 the manufacturers of such Products. With respect to Products sold after the
 Effective Date by Licensee, Licensee agrees to be financially responsible for
 the actual costs related to repairs and service of Products under, and in
 accordance with, Licensee’s written warranties to the extent such costs are
 not reimbursed by the manufacturers of such Products. With respect to
 Products received by either party for repair or service which are not under
 written warranty (regardless of who sold such Product), Licensee will be
 financially responsible for the actual costs related to repairs and services
 of such Products. In the event that Licensor receives Products for repair or
 service that are not under written warranty from a customer in a country in
 which Licensee is distributing the Products, and Licensor performs repairs or
 services related thereto in the ordinary course, Licensee will reimburse
 Licensor for its direct costs related thereto. 

 
	
  

 	
  

 
	
  

 	
           (ii)          Performance of Repairs and Services.
 With respect to the performance of repairs and services for Products after
 the Effective Date

 

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 (regardless
 of whether such Products are under any warranty), Licensor shall be
 responsible to perform or have performed such warranty obligations until such
 time as Product repair and service capabilities have been transferred to
 Licensee pursuant to the Transition Plan; provided,
 however, that in no event shall Licensee or Licensor be entitled
 to augment or expand the terms of Product warranties beyond the terms and
 conditions first offered by Licensor for such Products sold by Licensor
 before such transfer has occurred. Once such transfer has occurred, Licensee
 shall be responsible to perform or have performed the repairs and services
 for the Products. 

 
	
  

 	
  

 	
  

 
	
  

 	
           (b)
 Limited Returns for Certain Products.
 For a period of 90 days following the Effective Date, Licensor shall only
 accept the return by customers of Products sold by Licensor in the United
 States prior to the Effective Date up to a maximum of one hundred (100)
 units, provided that such
 Products must be undamaged and have greater than 4 months of shelf-life
 remaining at the time of return. In addition, Licensor shall only accept the
 foregoing limited returns on the condition that (i) Licensee agrees that it
 will not sell any Products to such customers for a period of 90 days after
 the applicable return date, and (ii) any such returned Product will be
 consigned to Licensee under Article 5. 

 
	
  

 	
  

 	
  

 
	
  

 	
           (c)   Manufacturers’ Warranties. Licensor and
 Licensee shall each have the rights described in the letter agreement with
 MediVision, Inc. dated August 16, 2011, the letter agreement with The MedTech
 Group, Inc. dated August 29, 2011, and the letter agreement with Bovie
 Medical Corporation dated August 31, 2011, in each case with respect to,
 among other things, the Parties’ rights under manufacturers’ warranties
 related to the Products. 

 

ARTICLE 4

REGULATORY TRANSITION;
QUALITY AGREEMENT

4.1       Regulatory Transition Plan. 

	
  

 	
  

 	
  

 
	
  

 	
  

 	
 (a)   Generally.

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           (i)          Subject
 to the Transition Plan, the Regulatory Transition Plan set forth on Schedule
 C (the “Regulatory Transition Plan”) and the Quality Agreement set forth
 in Schedule D (the “Quality Agreement”), Licensee will be responsible
 for achieving US Regulatory Transfer and all other necessary marketing
 approvals at its own expense and as soon as possible after Licensor completes
 the 510(k) Work (as defined below); provided
 that, Licensor will prepare and file at its own expense an
 appropriate 510(k) Notification, close out open FDA comments and letters to
 the file regarding the Products, and pursue achieving 510(k) clearance,
 including but not limited to responding to FDA questions (the “510(k) Work”)
 during the Initial Term in accordance with the Transition Plan and the
 schedule attached hereto as Schedule 4.1(a) which 

 

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 outlines
 the scope of such work (the “510(k) Work Schedule”), and subject to Section
 4.1(d) below. Licensor and Licensee will work together to complete the 510(k)
 Work and the US Regulatory Transfer in accordance with the Transition Plan
 and the 510(k) Work Schedule (subject to Section 4.1(d) below). 

 
	
  

 	
  

 
	
  

 	
           (ii)          Nothing
 in this Agreement, the License Agreement, the Acquisition Option Agreement or
 the Asset Purchase Agreement (collectively the “Transaction Documents”),
 shall be interpreted to transfer or grant Licensee any of Licensor’s rights
 to sell, distribute or have distributed Products in any jurisdiction where
 such activities would be prohibited, except in accordance with the Interim
 Distribution Agreement or through appropriate regulatory approvals,
 clearances or permits obtained by Licensee pursuant to the Transition Plan,
 the Regulatory Transition Plan and the Quality Agreement. Licensee and
 Licensor acknowledge and agree that the Transition Plan, the 510(k) Work
 Schedule, the Regulatory Transition Plan and the Quality Agreement are
 working documents that have been prepared by Licensor and Licensee to reflect
 their current intentions regarding the transition of regulatory approvals and
 clearances. Nothing in the Transition Plan, 510(k) Work Schedule, Regulatory
 Transition Plan or Quality Agreement shall be interpreted as expanding or
 diminishing representations, warranties and covenants of the Parties that are
 made pursuant to any of the other Transaction Documents, except only with
 respect to, and only to the extent of, commitments of each party that are
 specifically described in the Transition Plan, 510(k) Work Schedule,
 Regulatory Transition Plan or Quality Agreement. In the event of a conflict
 between the terms of the Transition Plan, the 510(k) Work Schedule, the
 Regulatory Transition Plan or the Quality Agreement, on the one hand, and
 this Agreement or any of the other Transaction Document, on the other hand,
 the terms of this Agreement and the other Transaction Documents shall
 control. 

 

            (b)     Recalls and Field Actions. After
the Effective Date but prior to occurrence of Regulatory Transfer in a given
country, Licensor shall (i) have the authority to make all decisions regarding
recalls and field actions and responses thereto with respect to the Products in
such countries, and (ii) be responsible for performing or having performed the
necessary corrective actions and management activities in response to such
recall or field corrective action, subject to Section 4.1(d) below. Licensee
will provide field resources to support Licensor in the performance of the
above-described activities, as directed by Licensor and all in accordance with
the Transition Plan. Notwithstanding the foregoing, each party will be
financially responsible for the direct costs of supporting the recall or
corrective action with respect to Products such party sold regardless of
whether the applicable Regulatory Transfer has occurred (but subject to Section
4.1(d)); provided, however, that
in the event that Licensee assists Licensor with Products sold by Licensor by
providing field resources in response to a recall or field action as directed
by Licensor, Licensor will reimburse Licensee for Licensee’s reasonable
out-of-pocket expenses related thereto, subject to the provision of competent
documentation thereof. 

9

             (c)     Product Changes. Subject to Section 4.1(d)
below with respect to Major Challenges, in
the event of routine Product changes, Licensor shall be responsible for
performing the necessary engineering and supply management activities until
such time as US Regulatory Transfer occurs, and Licensee shall provide support
related thereto, all in accordance with the Transition Plan. Each Party shall
bear its own costs in performing such activities. 

             (d)      Major Challenges. 

	
  

 	
  

 	
  

 
	
  

 	
           (i)       Notwithstanding
 anything to the contrary in this Agreement, and in addition to the deemed
 Major Challenge set forth in Section 2.2(a) above, in the event that after
 the Effective Date but prior to US Regulatory Transfer, any of the following
 occur, it shall be considered to be a “Major Challenge” hereunder: 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           a)          Licensor
 is unable to ship or allow shipment of Product for [ * * * ] days or more due
 to safety concerns; 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           b)          a
 new clinical trial involving the Product is required by the FDA; 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           c)          Product
 recalls, field actions, Product changes or other similar Product activities
 required by Applicable Law or any Regulatory Authority, including without
 limitation, by the FDA in connection with the 510(k) Work or US Regulatory
 Transfer, are necessary and which (x) cost or are reasonably expected to
 cost, individually or in the aggregate, [ * * * ] or more, the calculation of
 which shall exclude any Monthly Fees and Third Party Costs paid by Licensee
 to Licensor, or (y) individually or in the aggregate, are reasonably expected
 to take longer than six (6) months to address; or 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           d)          currently
 unforeseen problems that must be addressed by Licensor under Applicable Law
 to perform the Transition Services in accordance with the provisions of this
 Agreement which (x) cost, or are reasonably expected to cost, individually or
 in the aggregate, [ * * * ] or more, the calculation of which shall exclude
 any Monthly Fees and Third Party Costs paid by Licensee to Licensor, or (y)
 individually or in the aggregate, are reasonably expected to prevent US
 Regulatory Transfer from occurring by the earlier of, April 30, 2012, or the
 date that is six (6) months following Licensor’s submission of the 510(k)
 Notification referred to in Section 4.1(a) hereof. 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
 (ii)      In the event of a Major Challenge:

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
           a)          Licensor
 shall have the first option to determine in its reasonable discretion whether
 it elects to do the work and incur the costs 

 

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 necessary to respond to
 the Major Challenge (the “Major Challenge Option”);

 
	
  

 	
  

 
	
  

 	
           b)          In
 the event that Licensor elects not to exercise the Major Challenge Option,
 then Licensee shall have thirty (30) days to notify Licensor in writing
 whether it elects to exercise such Option at its own expense (the “Option
 Notice”), subject to the terms set forth herein. As soon as reasonably
 practicable following the receipt by Licensor of an Option Notice indicating
 the Licensee elects to exercise the Major Challenge Option, (1) Licensor will
 cease the 510(k) Work and will transfer such work to Licensee to the extent
 possible under Applicable Law, (2) Licensor will provide up to eighty (80)
 hours of regulatory or engineering support related to the 510(k) Work at no
 cost to Licensee in the month following such the exercise of such option, (3)
 both Parties will cooperate to complete the Transition Services within one
 month following the date of the Option Notice, and (4) the obligation for
 Licensee to pay Licensor the remaining unpaid License Fee under Section 3.1
 of the License Agreement (excluding the obligation to pay the Purchase Price
 under the Asset Purchase Agreement) on the twelve (12) month anniversary of
 the Effective Date will be automatically waived, subject to the continuing
 obligations of Licensee pursuant to Section 3.3 of the License Agreement (the
 “Major Challenge Transition Period”). For the avoidance of doubt, during the
 Major Challenge Transition Period, each party shall also continue to perform its
 applicable obligations under this Agreement, including without limitation,
 the payment obligations set forth under Article 2 hereof. Notwithstanding the
 foregoing, if the 510(k) Work cannot be transferred to Licensee within six
 (6) months following the date of the Option Notice, the parties shall discuss
 alternatives in good faith, and if the parties cannot mutually agree on next
 steps, the Major Challenge Transition Period shall end and either Party may
 terminate this Agreement and the other Transaction Documents in accordance
 with Section 9.2(b) hereof. In addition, if, after six (6) months of the date
 of the Option Notice, there are countries in which Licensee is distributing
 Product but with respect to which Regulatory Transfer has not yet occurred, Licensee
 will cease distributing Products in such country under the applicable Interim
 Distribution Agreement. 

 
	
  

 	
  

 
	
             (iii)     Notwithstanding
 anything contained herein to the contrary, if neither Party elects to
 exercise the Major Challenge Option, either Party may terminate this
 Agreement and the Transaction Documents in accordance Section 9.2(b) hereof.
 In the event of termination under Section 9.2(b), Licensor shall promptly
 refund to Licensee an amount equal to $250,000 (the “Major Challenge Refund”).
 Such a termination of the Agreement will not release Licensor or Licensee
 from any obligation that accrued prior to the effective date of such
 termination, but such a termination will release Licensee of any further
 payment

 

11

	
  

 	
  

 
	
  

 	
 obligation for any Minimum Royalty for a partial Contract Year except
 as set forth in Section 9.2(d) hereof, any License Fee not then due and
 payable, and any obligation to purchase Transferred Prostiva Assets under the
 Acquisition Option Agreement or to purchase Assets under the Asset Purchase
 Agreement. As further described in Section 9.2(b) hereof, the Major Challenge
 Refund and the foregoing termination right shall be the sole remedy available
 to Licensee in the event neither Party elects to exercise the Major Challenge
 Option, and neither party shall have any liability to other party or shall
 suffer any consequences as a result of Licensee’s termination pursuant to
 this Section, except as explicitly set forth in this Section 4.1(d)(iii) or
 Section 9.2(b) hereof. 

 

	
  

 	
  

 
	
  

 	
           (e)     Regulatory Reporting. After the
 Effective Date but prior to occurrence of Regulatory Transfer in a given
 country, Licensor shall be responsible for, with respect to any such country,
 all of the regulatory reporting related to such Products, and shall incur the
 costs associated therewith, in accordance with the Transition Plan. After
 Regulatory Transfer occurs in a given country, Licensee shall be responsible
 for all regulatory reporting for the Products and for bearing any costs
 related thereto. 

 
	
  

 	
  

 
	
  

 	
           (f) Safety Data Reporting and Exchange. In
 addition to Section 4.1(e) above, after the Effective Date but prior to
 Regulatory Transfer in a given country, Licensor shall be responsible for
 reporting the safety data regarding the Products, including reporting Product
 Complaints, to Regulatory Authorities. The Parties agree to amend this
 Agreement if reasonably necessary to comply with Applicable Laws, regulatory
 reporting requirements and obligations imposed by Regulatory Authorities.
 Licensor will provide Licensee a copy of any Product surveillance reports,
 including but not limited to Product Complaint trend reports, that are
 generated during the normal course of business. In addition, Licensor and
 Licensee agree the following shall apply from the Effective Date until
 Regulatory Transfer occurs in a given country: 

 

	
  

 	
  

 
	
  

 	
           (i)          Contact Points. Each Party will
 designate a contact point(s) for the other Party to provide safety data under
 this Agreement. Each Party will provide the safety data pertaining to the
 Product that is required to be provided under this Agreement to the other
 Party’s designated contact point. A Party may change its designated contact
 point by written notice to the other Party’s most recently identified contact
 point. The Parties’ initial designated contact points shall be as set forth
 in Schedule 4.1(f) (the “Contact List”). 

 
	
  

 	
  

 
	
  

 	
           (ii)          Exchange of Safety Data. Within 24 hours
 from the Licensee Awareness Date of a Product Complaint, Licensee will send
 by secure email a Valid Report(s) to Licensor for any Product Complaint(s)
 identified by Licensee as Product-related, that reference a Product or that,
 in Licensee’s reasonable judgment, appear to involve a Product (collectively,
 “Product Complaint”). In addition, Licensee will immediately provide to
 Licensor any Valid Reports that were not initially reported as being Product
 Complaints but that Licensee later reasonably determines to be Product
 related. If Licensee believes that there is a 

 

12

	
  

 	
  

 
	
  

 	
 safety issue that could result in a Serious Adverse Event (“SAE”), it
 will immediately notify Licensor of such issue but in no event shall it
 notify Licensor later than 24 hours from the Licensee Awareness Date.
 Licensee agrees to make best efforts to acquire and report as much
 information as possible in the initial Product Complaint, and when submitting
 the Valid Report to Licensor, Licensee will provide all information requested
 on the Valid Report that is reasonably known. Licensor shall be responsible
 for any follow-up investigation of a Product Complaint. Licensee shall not
 conduct further investigation of a Product Complaint previously exchanged,
 except as reasonably requested by Licensor. If Licensor so requests, Licensee
 agrees to promptly conduct follow-up investigation. Licensee will provide to
 Licensor in writing the results of such further investigation within the
 timeframe specified above and shall include the Licensor reference number on
 the documentation (e.g., PCIR#). In addition, Licensor may request and
 Licensee agrees to promptly provide review and feedback on all or a portion
 of all Product Complaints that Licensor intends to include in (but is not
 limited to) annual reports, final reports and reports to support other
 regulatory submissions to Regulatory Authorities in connection with the
 Product. After Licensor has made the appropriate regulatory filings it will
 email to Licensee copies of those reports for Product Complaints. To
 facilitate reconciliation of the exchanged data, prior to the time that all
 Regulatory Transfers have occurred, Licensee will provide to Licensor within
 the first thirty (30) days of each month contained therein, a monthly listing
 of all Valid Reports sent to Licensor during the previous month. Information
 exchanged under this Subsection will be in English, except that translation
 of materials not originally generated by a Party is not required if
 translation would be substantially burdensome, and the Party providing the
 material otherwise makes reasonable efforts to summarize or describe in
 English the document and its relation to patient safety. 

 
	
  

 	
  

 
	
  

 	
           (iii)          Internal Systems. Each Party will keep
 an individualized written record of each of its Product Complaints to the
 extent required under its standard operating procedures (SOPs) and Applicable
 Law. Each Party will maintain its own SOPs for receiving, investigating,
 tracking, following up, storing and reporting Product Complaints. Licensor
 may audit Licensee for compliance with the requirements under this Section
 4.1(f) only for cause. Audits will be scheduled in advance and will be
 conducted during normal business hours. 

 
	
  

 	
  

 
	
  

 	
           (iv)          Regulatory Reports and Requests. From
 the Effective Date until Regulatory Transfer occurs in a given country,
 Licensee will send to Licensor by secure email within 24 hours of its
 receipt, a copy of any correspondence from that country’s Regulatory
 Authority specifically involving the Product, with the exception that any
 information not specifically involving the Product may be redacted at
 Licensee’s discretion. To the extent reasonably possible, Licensee will
 provide Licensor with a copy of any documentation pertaining to the request
 and the response to a Regulatory Authority prior to submission of the
 response for 

 

13

	
  

 	
  

 
	
  

 	
 comments. If time constraints make it impossible or unreasonable to
 provide Licensor with a copy of the response before submission, Licensee will
 use diligent efforts to notify Licensor of the circumstances and coordinate
 in good faith with regard to any areas for Licensor’s input. Licensee will
 not unreasonably reject suggestions by Licensor for changes in the proposed
 submission. Licensor will use diligent efforts to respond in a reasonable period
 of time. In addition, Licensee will provide to Licensor a copy of its
 responses to any Regulatory Authority’s request. After the Regulatory
 Transfer in any country, Licensee will keep records of all Regulatory Reports
 and Requests as mandated by Applicable Law, and will provide Licensor with a
 monthly report summarizing trend analysis and results but only until the date
 upon which Licensor’s labeled Products are no longer being offered for sale
 by Licensor or its agents or distributors anywhere in the world. 

 

	
  

 	
  

 
	
  

 	
           (g) Complaint Handling. After the Effective
 Date but prior to occurrence of Regulatory Transfer in a given country,
 Licensor shall be responsible for the performance of complaint follow-up
 activities, analysis trending and decision making regarding complaints, and
 shall bear the costs associated therewith, and Licensee shall be responsible
 for performing initial customer interaction activities and data collection,
 and shall bear the costs associated therewith, all in accordance with the
 Transition Plan. From the date of the applicable Regulatory Transfer in a
 given country and thereafter, Licensee shall be responsible for performing
 all complaint handling activities for the Products and bearing any costs
 related thereto. 

 
	
  

 	
  

 
	
  

 	
           (h) Customer Service, Sales Support, Field Servicing
 and Technical Services. From and after the Effective Date, subject
 to the terms and conditions of this Agreement, each Party is responsible for
 performing customer service activities, sales support activities, field
 servicing coordination, and technical services activities for the Products
 described in the Transition Plan. Any costs associated with the foregoing
 shall be borne solely by the Party who performs the services in accordance
 with the Transition Plan. 

 

             4.2
Quality Agreement. Licensee and Licensor shall comply in all
material respects with the terms of the Quality Agreement set forth in Schedule D. In the event of a conflict between the terms of the Quality Agreement and
the balance of this Agreement (other than the Interim Distribution
Agreement(s)) or any of the other Transaction Documents, the terms of the
balance of this Agreement (other than the Interim Distribution Agreement(s))
and the other Transaction Documents shall control. In the event of a conflict
between the terms of the Quality Agreement and the terms of the Interim
Distribution Agreement(s), the terms of the Quality Agreement shall control.  

ARTICLE 5

CONSIGNMENT INVENTORY

             5.1
Consignment and Use of US Consignment Inventory. As of the
Effective Date, Licensor shall consign, and Licensee shall accept (a) the
finished goods inventory of Product 

14

located in Licensor’s distribution centers or other U.S. field
locations which have been manufactured for, or are held or used primarily for,
the conduct of the Prostiva Business identified in Schedule 5.1 to this
Agreement, and which are new, unexpired and not due to expire within six (6)
months of the date of consignment, and (b) Products returned to Licensor in
accordance with Section 3.3(b) above (the “US Consignment Inventory”), except
for that inventory that Licensor anticipates will be necessary to fulfill
orders received from its customers or distributors outside of the United States
in accordance with Section 3.2 hereof (the “OUS Consignment Inventory”) during
the three (3) month period following the Effective Date (the “Consignment
Period”) (The US Consignment Inventory and OUS Consignment Inventory are
collectively referred to as the “Consignment Inventory”). Licensee will use the
US Consignment Inventory as needed to fulfill orders it receives as Licensor’s
distributor of Products pursuant to the terms of the Interim Distribution
Agreement. Licensee shall sell Consignment Inventory prior to selling Products
received under new purchase orders. 

             5.2
Consignment and Use of OUS Consignment Inventory. Upon the
expiration of each of the Licensor EU Transition Period and the applicable
Licensor OUS / OEU Transition Periods, as determined on a country-by-country
basis, Licensee shall accept consignment of any remaining OUS Consignment
Inventory that is new, unexpired and not due to expire within six (6) months of
the date of consignment and in salable condition which Licensor purchases back
from any of its distributors outside of the United States. 

             5.3
Shipment of Consignment Inventory. As soon as practicable after
the Effective Date, Licensor will make the US Consignment Inventory available
and Licensee will arrange for shipment, at Licensee’s expense, of the US
Consignment Inventory to Licensee’s facility located at 14405 21st Avenue
North, Minneapolis, MN 55447 (the “Facility”). As soon as practicable after the
expiration of the Licensor EU Transition Period and each Licensor OUS / OEU Transition
Period, as applicable, Licensor will make available and Licensee will arrange
and pay for shipping the specified OUS Consignment Inventory to the Facility;
provided that Licensee may reject, and will not be obligated to pay for any OUS
Consignment Inventory that, upon receipt and inspection following receipt
thereof, is not new, is expired (or due to expire within six months of the
consignment date) or is not in saleable condition. Licensee must notify
Licensor in writing of any rejection of OUS Consignment Inventory within ten
(10) business days following receipt thereof, and if Licensee fails to do so,
such inventory will be deemed accepted by Licensee. In each case, Licensee
shall pay for all shipping costs for Consignment Inventory (other than rejected
Consignment Inventory) and for any insurance necessary to cover such
Consignment Inventory during shipment but shall not pay for handling. 

             5.4
Duration of Consignment Period; Title. For the avoidance of
doubt, both the US Consignment Inventory and the OUS Consignment Inventory will
be consigned by Licensor for a maximum period of nine (9) months following the
Effective Date (the “Consignment Period”). Licensor shall retain title to the
US Consignment Inventory and OUS Consignment Inventory until the earlier to
occur of (i) Licensee’s removal of any Product from the Consignment Inventory,
or (ii) the expiration of the Consignment Period.

15

             5.5
Price, Reports and Payment. The prices to be paid by Licensee for
the Consignment Inventory shall be as set forth on Schedule 5.5 hereof.
Licensee shall submit a written report to Licensor within ten (10) business
days after the end of each calendar month during the Consignment Period setting
forth the number of Product removed from inventory during the previous calendar
month, and the number of Products remaining in the Consignment Inventory. Based
on such report, Licensor shall issue an invoice for the number of Products
removed by Licensee from the Consignment Inventory and Licensee shall pay such
invoice within nine (9) months of the fifteenth (15th) day of that
month. Within ten (10) business days following the expiration of the
Consignment Period, Licensee shall submit a final report to Licensor setting
forth the number of Products remaining in the Consignment Inventory (if any).
Based on such final report, Licensor shall issue an invoice for the number of
Products remaining in the Consignment Inventory and documentation of the
invoiced cost to Licensor, at which time title shall have passed to Licensee,
and Licensee shall pay such invoice within nine (9) months following the
expiration of the Consignment Period. 

             5.6
Risk of Loss. Licensee will bear the risk of loss for the
Consignment Inventory once it has been shipped to Licensee’s facility as
provided in Section 4.3. Once placed on the carrier for shipment, Licensor
shall not be liable for any damage or unexplained disappearance of the
Consignment Inventory. 

ARTICLE 6 

SUPPLY OF PRODUCT COMPONENTS

             6.1
Bovie Products. Subject to the terms and conditions of this
Agreement and as requested by Licensee, Licensor agrees to place one last time
buy order on Licensee’s behalf under that certain Development and Supply
Agreement by and between Licensor and Bovie Medical Corporation (“Bovie”) dated
September 15, 2003, as amended (“Bovie Agreement”), and Licensee agrees to
purchase such requested products (the “Bovie Products”) from Licensor.
Licensor’s obligation to place orders under the Bovie Agreement is subject to
the terms and conditions thereof, including without limitation, the termination
of such agreement. Licensee understands and acknowledges that the Bovie
Agreement will terminate on December 31, 2011, and nothing contained herein
shall require Licensor to seek modification to the terms and conditions of the
Bovie Agreement, including without limitation, extension thereof, or to enter
into any new supply agreements with any of Licensor’s previous suppliers or
with other third parties in order to fulfill Licensor’s obligations under this
Agreement. 

             6.2
MedTech Products. Subject to the terms and conditions of this
Agreement and as requested by Licensee, Licensor agrees to place orders for
handpieces (the “MedTech Products”) on a monthly basis until US Regulatory
Transfer occurs on Licensee’s behalf under that certain Manufacturing and
Supply Agreement with The MedTech Group, Inc., dated August 6, 2010 (“MedTech
Agreement”). Licensor’s obligation to place orders under the MedTech Agreement
is subject to the terms and conditions thereof, including without limitation,
the termination of such agreement. Nothing contained herein shall require 

16

Licensor to seek modification to the terms and conditions of the
MedTech Agreement, including without limitation, extension thereof, or to enter
into any new supply agreements with any of Licensor’s previous suppliers or
with other third parties in order to fulfill Licensor’s obligations under this
Agreement. 

             6.3
MediVision Products. Licensor shall assign to Licensee the
MediVision, Inc. Sales Orders described in the letter agreement by and among
Licensor, Licensee and MediVision, Inc. dated August 16, 2011 (the “MediVision
Agreement”), in accordance with the MediVision Agreement. 

             6.4
Price. Licensor shall sell Licensee each Bovie Product and
MedTech Product ordered by Licensor on Licensee’s behalf pursuant to this
Article 6 at Licensor’s invoiced cost. Notwithstanding the foregoing, Licensor
may adjust the price of any Bovie Product or MedTech Product for an amount
equal to any tax levied on it with respect to the sale, use or delivery of the
Bovie Products or MedTech Products, as applicable (other than taxes based upon
the income of Licensor), including sales tax, use tax, gross receipts tax, and
value added tax, in each case to the extent payable by the Licensor or required
to be collected by Licensor. Licensee will arrange for shipping of the Bovie
Products and MedTech Products to Licensee’s Facility at Licensee’s expense. 

             6.5
Payment. Licensee shall pay all invoices for Bovie Products ordered by
Licensor on Licensee’s behalf pursuant to this Article 6 in full within 30 days
following date of all such invoices. Licensee shall pay Licensor within 270
days of invoice date for all invoices for MedTech Products received within four
(4) months of the Effective Date; thereafter, .Licensee shall pay all invoices
for MedTech Products ordered by Licensor on Licensee’s behalf pursuant to this
Article 6 in full within 30 days following date of all such invoices.  

             6.6
Generators. Promptly following the Effective Date, Licensor, at
its own expense, shall transfer, convey, assign and deliver to Licensee at the
Facility all right, title and interest to thirty (30) Prostiva generators,
which generators shall be [ * * * ]. 

ARTICLE 7 

INTELLECTUAL PROPERTY; CONFIDENTIALITY

             7.1
Intellectual Property. Nothing in this Agreement shall be
construed as an assignment or grant of any rights with respect to either party’s
intellectual property, or to modify the terms and conditions of any other
Transaction Agreement. 

             7.2
Confidentiality. All Confidential Information obtained by the
parties in connection herewith shall be subject to the parties’ confidentiality
obligations under the License Agreement. 

17

ARTICLE 8 

PERFORMANCE; REPRESENTATIONS; DISCLAIMER; INDEMNIFICATION

             8.1
Standard of Performance for Services. Each Party shall perform
all services pursuant to this Agreement in a commercially reasonable manner.
Each Party and its Affiliates, as applicable, will perform services in the
manner and the relative level of quality and service consistent in all material
respects with those performed by such Party and its Affiliates prior to the date
hereof. 

             8.2
Representations and Warranties. Licensor represents and warrants
that: 

	
  

 	
  

 
	
  

 	
           (a)
 Licensor has good title to the Consignment Inventory, free and clear of liens
 and encumbrances;

 
	
  

 	
  

 
	
  

 	
           (b)
 Licensor has not extended any written warranty to a customer beyond the
 written warranties referred to in Section 3.3(a)(i) of this Agreement;

 
	
  

 	
  

 
	
  

 	
           (c)
 Licensor has not adulterated or misbranded (within the meanings of the
 Federal Food, Drug and Cosmetic Act, as amended) the Consignment Inventory or
 Prostiva generators to be transferred to Licensee under this Agreement; and 

 
	
  

 	
  

 
	
  

 	
           (d) All
 of the Consignment Inventory to be consigned to Licensee hereunder shall be
 in saleable condition in the ordinary course of business on the date of
 consignment.

 

             8.3
No Other Warranty for Products. EXCEPT AS SET FORTH IN THIS
AGREEMENT OR THE OTHER TRANSACTION AGREEMENTS, LICENSOR MAKES NO OTHER
WARRANTIES WITH RESPECT TO THE PRODUCTS WHICH ARE CONSIGNED, TRANSFERRED OR
SOLD TO LICENSEE HEREUNDER. EXCEPT AS SET FORTH IN THIS AGREEMENT OR THE OTHER
TRANSACTION AGREEMENTS, THE PRODUCTS ARE CONSIGNED, SOLD OR TRANSFERRED
HEREUNDER IN “AS IS/WHERE IS” AND “WITH ALL FAULTS” CONDITION, WITH ALL
WARRANTIES AND REPRESENTATIONS BEING EXPRESSLY DISCLAIMED AND WAIVED. LICENSEE
HEREBY ACKNOWLEDGES AND AGREES THAT LICENSOR MAKES NO OTHER REPRESENTATIONS OR
WARRANTIES WHATSOEVER, EXPRESS OR IMPLIED, UNDER THIS AGREEMENT WITH RESPECT TO
ANY MATTER RELATING TO THE PRODUCTS, INCLUDING, WITHOUT LIMITATION, INCOME TO
BE DERIVED OR EXPENSES TO BE INCURRED IN CONNECTION WITH THE PRODUCTS, THE
TRANSFERABILITY OF THE PRODUCTS, THE MERCHANTABILITY OR FITNESS OF THE PRODUCTS
FOR ANY PARTICULAR PURPOSE, ANY IMPLIED WARRANTY OR CONDITION ARISING FROM A
COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE, ANY IMPLIED
WARRANTY OR CONDITION OF DURABILITY OR DESCRIPTION, OR ANY OTHER MATTER OR
THING RELATING TO THE PRODUCTS OR ANY PORTION THEREOF. 

             8.4
Indemnification. 

18

	
  

 	
  

 
	
  

 	
           (a) Indemnification
 by Licensee. Pursuant to Section 8.1(a) of the License Agreement, and
 subject to Sections 2.2(a)(v) and 4.1(d)(iii) of this Agreement, Licensee
 shall indemnify Licensor, and any other Medtronic Indemnitees, and defend and
 save each of them harmless, from and against any and all Losses in connection
 with any and all Third Party Claims to the extent arising from or occurring
 as a result of the breach by Licensee of any representation or warranty, or
 the material breach of a covenant, under this Agreement. 

 
	
  

 	
  

 
	
  

 	
           (b) Indemnification
 by Licensor. Pursuant to Section 8.2(a) of the License Agreement, and
 subject to Sections 2.2(a)(v) and 4.1(d)(iii) of this Agreement, Licensor
 shall indemnify Licensee, and any other Urologix Indemnitees, and defend and
 save each of them harmless, from and against any and all Losses in connection
 with any and all Third Party Claims to the extent arising from or occurring
 as a result of the breach by Licensor of any representation or warranty, or the
 material breach of a covenant, under this Agreement. 

 
	
  

 	
  

 
	
  

 	
           (c) Indemnification
 as Sole Remedy for Third Party Claims. Other than the equitable relief
 described in Section 10.13 hereof, the remedies set forth in Sections
 2.2(a)(v) and 4.1(d)(iii) hereof, and the termination rights set forth in
 Section 9.2 hereof, indemnification pursuant to this Section 8.4 shall be a
 party’s sole remedy for Third Party Claims arising hereunder. 

 
	
  

 	
  

 
	
  

 	
           (d) Contribution.
 With respect to any Third Party Claim for which both parties have an
 obligation to indemnify the other pursuant to this Section 8.4, the
 provisions set forth in Section 8.3 of the License Agreement (Contribution)
 shall be incorporated herein by reference and shall apply. 

 
	
  

 	
  

 
	
  

 	
           (e) Procedure
 for Indemnification. The procedures for indemnification set forth in
 Section 8.4 of the License Agreement (Procedure for Indemnification) shall be
 incorporated herein by reference and shall apply to any indemnification
 claims under this Section 8.4. 

 
	
  

 	
  

 
	
  

 	
           (f) Exclusions
 / Limitations. All claims arising under this Agreement, including but not
 limited to, direct claims and in the case of indemnification, for Third Party
 Claims, are subject to the exclusions and limitations set forth in Section
 8.6 of the License Agreement (including all of its subsections) and shall be
 incorporated herein by reference. 

 

ARTICLE 9 

TERM AND TERMINATION

             9.1
Term. The term of this Agreement shall commence on the date
hereof and shall expire on the twelve (12) month anniversary hereof, except
with respect to services expressly agreed to by Licensor in writing to be
performed after such period pursuant to the terms of this Agreement (the
“Term”), and provided that, if US
Regulatory Transfer has not occurred 

19

within such twelve (12) month period, this Agreement shall be
automatically extended for a period of three (3) months. 

             9.2
Termination. 

	
  

 	
  

 
	
  

 	
           (a) By Licensor. Except as set forth in this
 Section 9.2, Licensor may terminate this Agreement in the event Licensee
 materially breaches this Agreement, including the terms and conditions of the
 Interim Distribution Agreement and the Quality Agreement, and such breach
 remains uncured for sixty (60) days’ following written notice from Licensor
 specifying in detail the claimed breach by Licensee of this Agreement and
 required corrective action. Licensee shall not be deemed in breach of a
 particular obligation under this Agreement to the extent Licensee’s
 performance is delayed or prohibited due to Licensor’s failure to meet
 Licensor’s obligations under this Agreement. 

 
	
  

 	
  

 
	
  

 	
           (b) By Either Party. Either Party may
 terminate this Agreement in connection with a Major Challenge only in the
 specific circumstances set forth in Section 4.1(d)(ii) and Section
 4.1(d)(iii) hereof. Such a termination of the Agreement will not release
 Licensor or Licensee from any obligation that accrued prior to the effective
 date of such termination, but such a termination will release Licensee of any
 further payment obligation for any Minimum Royalty for a partial Contract
 Year, any License Fee not then due and payable, and any obligation to
 purchase Transferred Prostiva Assets under the Acquisition Option Agreement
 or to purchase Assets under the Asset Purchase Agreement. Except as set forth
 in Section 4.1(d)(iii) with respect to a termination in connection with
 Section 4.1(d)(ii) hereof, such a termination shall be the sole and exclusive
 remedy available to the applicable terminating Party, and neither party shall
 have any direct liability to the other party or obligation to indemnify the
 other party, including without limitation pursuant to Section 8.4 hereof or
 Article 8 of the License Agreement, or shall suffer any consequences as a
 result of such Party’s decision to terminate pursuant to this Section, except
 as explicitly set forth herein or in the License Agreement. Notwithstanding
 the foregoing, in the event of any such termination, (i) the terminating
 Party shall give the other Party fifteen (15) days’ advance written notice
 thereof, (ii) during or after such period, the Parties shall meet to discuss
 and document, in good faith, a plan to unwind the transition of the Prostiva
 Business from Licensor to Licensee that had occurred prior to the effective
 date of termination, including without limitation, with respect to the
 treatment of Consignment Inventory; and (iii) the provisions set forth in
 Sections 6.4 and 6.5.3 of the License Agreement are incorporated herein by
 reference and shall apply as set forth therein. 

 
	
  

 	
  

 
	
  

 	
           (c) By Licensee. Licensee may terminate this
 Agreement in connection with excessive Third Party Costs as described in
 Section 2.2(a)(v) hereof. Such a termination of the Agreement will not
 release Licensor or Licensee from any obligation that accrued prior to the
 effective date of such termination, but such a termination will release
 Licensee of any further payment obligation for any Minimum Royalty for a
 partial Contract Year except as set forth in Section 9.2(d), any License Fee
 not then due and 

 

20

	
  

 	
  

 
	
  

 	
 payable, and any obligation to purchase Transferred Prostiva Assets
 under the Acquisition Option Agreement or to purchase Assets under the Asset
 Purchase Agreement. Except as set forth in Section 2.2(a)(v), such a termination
 shall be the sole and exclusive remedy available to the Licensee, and neither
 party shall have any direct liability to the other party or obligation to
 indemnify the other party, including without limitation pursuant to Section
 8.4 hereof or Article 8 of the License Agreement, or shall suffer any
 consequences as a result of such Party’s decision to terminate pursuant to
 this Section, except as explicitly set forth herein or in the License
 Agreement. Notwithstanding the foregoing, in the event of any such
 termination, (i) the Licensee shall give Licensor fifteen (15) days’ advance
 written notice thereof, (ii) during or after such period, the Parties shall
 meet to discuss and document, in good faith, a plan to unwind the transition
 of the Prostiva Business from Licensor to Licensee that had occurred prior to
 the effective date of termination including without limitation, with respect
 to the treatment of Consignment Inventory; and (iii) the provisions set forth
 in Sections 6.4 and 6.5.3 of the License Agreement are incorporated herein by
 reference and shall apply as set forth therein. 

 
	
  

 	
  

 
	
  

 	
           (d) Inventory. In the event of termination
 of this Agreement, Licensee shall (i) return to Medtronic all finished goods
 inventory of Product consigned to it pursuant to this Agreement and (ii)
 provide Licensor the right to purchase, at Licensee’s cost, all finished
 goods inventory of Product owned by Licensee which have been manufactured
 for, or are held or used primarily for, the conduct of the Prostiva Business
 and which are new, unexpired and not due to expire within six (6) months of
 the date of termination. In the event Licensor does not exercise its right to
 purchase the Licensee owned inventory, Licensee shall have an additional 90
 days after termination of this Agreement to sell the inventory under the
 licenses granted in the License Agreement as set forth in Section 6.5.6 of
 the License Agreement, as if the Interim Distribution Agreement had not
 terminated. 

 
	
  

 	
  

 
	
  

 	
           (e) Survival. The Parties’ obligations
 pursuant to Article 7, Article 10 and Sections 2.2(a)(v), 2.3, 4.1(d)(iii),
 8.4, and 9.2 hereof, and any other express terms and provisions hereof to be
 performed by the parties after the termination hereof, shall survive the
 expiration or termination of this Agreement in accordance with their
 respective terms. 

 

ARTICLE 10 

MISCELLANEOUS

             10.1          Complete
Agreement. This Agreement, including all schedules and exhibits annexed
hereto, contain the entire understanding of the Parties hereto with respect to
the subject matter contained herein. 

             10.2          Waiver
and Amendment. This Agreement may be amended, or any provision of this
Agreement may be waived, provided that any such amendment or waiver will be
binding on a party hereto only if such amendment or waiver is set forth in a
writing 

21

executed by such party. The waiver by any party hereto of a breach of
any provision of this Agreement shall not operate or be construed as a waiver
of any other breach. 

             10.3          Notices.
All notices and other communications hereunder shall be in writing and shall be
deemed to have been given only if and when (i) personally delivered, or (ii)
three (3) business days after mailing, postage prepaid, by certified mail, or
(iii) when delivered (and receipted for) by an overnight delivery service, or
(iv) when first sent by facsimile provided such communication is promptly
confirmed, addressed in each case as follows: 

	
  

 	
  

 
	
 If to
 Licensee:

 
	
  

 	
  

 
	
  

 	
 Urologix
 Inc. 

 
	
  

 	
 14405 21st Avenue
 North

 
	
  

 	
 Minneapolis,
 MN 55447

 
	
  

 	
 Attn: Greg
 Fluet

 
	
  

 	
 Fax:
 763-475-1443

 
	
  

 	
  

 
	
 With a copy
 to:

 
	
  

 	
  

 
	
  

 	
 Lindquist
 & Vennum P.L.L.P. 

 
	
  

 	
 80 S. 8th
 Street, Suite 4200 

 
	
  

 	
 Minneapolis,
 MN 55402 

 
	
  

 	
 Attention:
 Charles P. Moorse and Barbara Rummel 

 
	
  

 	
 FAX No:
 (612) 371-3207 

 
	
  

 	
  

 
	
 If to
 Licensor:

 
	
  

 	
  

 
	
  

 	
 Medtronic,
 Inc. 

 
	
  

 	
 World
 Headquarters 

 
	
  

 	
 710
 Medtronic Parkway 

 
	
  

 	
 Minneapolis,
 MN 55432-5604 

 
	
  

 	
  

 
	
 With
 separate copies thereof addressed to:

 
	
  

 	
  

 
	
  

 	
 Attention:          General
 Counsel 

 
	
  

 	
 FAX
 No.:          (763)
 572-5459 

 
	
  

 	
  

 
	
  

 	
 -and- 

 
	
  

 	
  

 
	
  

 	
 Attention:     Vice
 President and Chief Development Officer

 
	
  

 	
 FAX
 No.:          (763)
 505-2542 

 

22

Either the Licensor or the Licensee may change the address(es) for the
giving of notices and communications to it, and/or copies thereof, by written
notice to the other Party in conformity with the foregoing. 

             10.4          Expenses.
Except as may be expressly provided herein, Licensor and Licensee shall each
pay their own expenses (including, but not limited to, all compensation and
expenses of counsel, financial advisors, consultants, actuaries and independent
accountants) incident to this Agreement and the preparation for, and
consummation of, the transactions provided for herein. 

             10.5          Governing
Law. This Agreement shall be governed by, and construed, interpreted and
enforced under, the laws of the State of Minnesota without giving effect to its
conflict of laws principles. 

             10.6          Jurisdiction
and Venue. Each Party hereby irrevocably submits to the exclusive
jurisdiction of the courts located in Hennepin County, Minnesota, in respect of
any claim relating to the interpretation and enforcement of the provisions of
this Agreement and of the documents referred to in this Agreement, or otherwise
in respect of the transactions contemplated hereby and thereby, and hereby
waives, and agrees not to assert, as a defense in any action, suit or
proceeding in which any such claim is made that it is not subject thereto or
that such action, suit or proceeding may not be brought or is not maintainable
in such courts or that the venue thereof may not be appropriate or that this
Agreement or any such document may not be enforced in or by such courts. 

             10.7          Relationship.
This Agreement does not make either party the employee, agent or legal
representative of the other for any purpose whatsoever. Neither party is
granted any right or authority to assume or to create any obligation or
responsibility, express or implied, on behalf of or in the name of the other
party. In fulfilling its obligations pursuant to this Agreement, each party
shall be acting as an independent contractor. 

             10.8          Assignment.
Neither Party shall assign this Agreement, or any right or obligation thereunder,
to any third party without the prior written consent of the other Party. This
Agreement shall be binding upon and be for the benefit of the Parties and their
respective successors and permitted assigns. In the event either Party (the
“Assigning Party”) merges or consolidates with another entity or sells
substantially all of its assets to another person or entity, or if there is a
change in control of the Assigning Party or other corporate reorganization or
transaction affecting the Assigning Party (an “Acquisition”), no consent of the
other Party shall be required, but this Agreement shall remain in full force
and effect and the Assigning Party shall assign and transfer (whether by
operation of law or otherwise) this Agreement to the entity with which it has
merged or consolidated, the new owners of the assets, the new owners of the
Assigning Party or the surviving entity in the reorganization or corporate
transaction, as the case may be, and shall cause that entity or person to
assume and agree to perform the entirety of this Agreement, but shall remain
responsible for its obligations hereunder notwithstanding such assumption. 

23

             10.9          Titles
and Headings; Construction. The titles and headings herein are inserted for
the convenience of reference only and are not intended to be a part of or to
affect the meaning or interpretation of this Agreement. This Agreement shall be
construed without regard to any presumption or other rule requiring
construction hereof against the party causing this Agreement to be drafted. 

             10.10        Third
Parties. Nothing herein expressed or implied is intended or shall be
construed to confer upon or give to any Person, other than the parties to this
Agreement and their respective permitted successors and assigns, any rights or
remedies under or by reason of this Agreement. 

             10.11        Illegality.
In case any provision of this Agreement shall be invalid, illegal or
unenforceable, the validity, legality and enforceability of the remaining
provisions shall not in any way be affected or implied thereby. 

             10.12        Counterparts.
This Agreement may be executed simultaneously in two or more counterparts, each
of which shall be deemed an original but all of which together shall constitute
one and the same agreement and shall become effective when one or more
counterparts have been signed by each of the parties hereto and delivered to
the other. In the execution of this Agreement, facsimile, scanned or
electronically delivered signatures shall be fully effective for all purposes. 

             10.13        Remedies.
The Parties agree, that in addition to any other relief afforded under the
terms of this Agreement or by law, each Party has the right to seek equitable
remedies, including specific performance and enforcement of this Agreement by
injunction issued against the other Party, it being understood that both
damages and equitable remedies will be proper modes of relief and are not to be
considered as alternative remedies. 

[Signatures
follow]

24

EXHIBIT 10.2 

                  IN
WITNESS WHEREOF, the parties have executed this Transition Services and Supply
Agreement as of the Effective Date. 

	
  

 	
  

 	
  

 
	
  

 	
 UROLOGIX INC. 

 
	
  

 	
  

 
	
  

 	
 By: /s/ Stryker Warren Jr.
 

 	
  

 
	
  

 	
  

 
	
  

 	
 Name: Stryker Warren Jr. 

 
	
  

 	
  

 
	
  

 	
 Title: Chief Executive
 Officer 

 
	
  

 	
  

 
	
  

 	
 MEDTRONIC, INC. 

 
	
  

 	
  

 
	
  

 	
 By: /s/ Thomas M. Tefft 

 	
  

 
	
  

 	
  

 
	
  

 	
 Name: Thomas M. Tefft 

 
	
  

 	
  

 
	
  

 	
 Title: Senior Vice
 President & President, Neuromodulation 

 

25

CERTAIN
INFORMATION INDICATED BY [ * * * ] HAS BEEN DELETED FROM THESE SCHEDULES AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2. 

Schedule A

Transition Plan

See attached.

 

	
  

 	
  

 
	
 MEDTRONIC
 CONFIDENTIAL DOCUMENT

 	
 SCHEDULE A 

 

Transition Plan 

	
  

 	
  

 	
  

 
	
Transition
Team Leaders:

 
	
  

 	
 o

 	
 o Greg
 Fluet, EVP & COO

 
	
  

 	
 o

 	
 o Eric
 Schantz, Business 

 

Transition
Team: 

	
  

 	
  

 	
  

 	
  

 
	
 Licensee Transition Team

 
	
 Team Lead/Business Dev

 	
  

 	
  

 	
 Greg Fluet

 
	
 Corporate Development

 	
  

 	
  

 	
 Greg Fluet

 
	
 Europe Manager

 	
  

 	
  

 	
 TBD (Greg
 Fluet)

 
	
 Marketing

 	
  

 	
  

 	
 Annette
 Johnson

 
	
 R&D

 	
  

 	
  

 	
 Ralph
 Cardinal

 
	
 Supply Chain

 	
  

 	
  

 	
 Brian Wegber

 
	
 Manufacturing

 	
  

 	
  

 	
 Charlie
 Lehman

 
	
 Quality/Regulatory

 	
  

 	
  

 	
 Jennifer
 Willner

 
	
 Finance

 	
  

 	
  

 	
 Brian Smrdel

 
	
 Legal

 	
  

 	
  

 	
 Charles
 Moorse (Corporate)

 
	
  

 	
  

 	
  

 	
 Rich Billion
 & Tim Clise (IP)

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
  

 	
  

 
	
 Licensee Transition Team

 
	
 Team Lead/Business Dev

 	
  

 	
  

 	
 Eric Schantz

 
	
 Corporate Development

 	
  

 	
  

 	
 Brooke Story

 
	
 Europe Manager

 	
  

 	
  

 	
 Ubi Van den
 Hombergh

 
	
 Marketing

 	
  

 	
  

 	
 Judy Johnson

 
	
 R&D

 	
  

 	
  

 	
 Brent
 Torgenson

 
	
 Supply Chain

 	
  

 	
  

 	
 Susan
 Whittemore

 
	
 Manufacturing

 	
  

 	
  

 	
 Sara McKee

 
	
 Quality/Regulatory

 	
  

 	
  

 	
 Andrea
 Rasmussen, Tom Reichel

 
	
 Finance

 	
  

 	
  

 	
 Brian Nelson

 
	
 Legal

 	
  

 	
  

 	
 Orland
 Flores (Neuro)

 
	
  

 	
  

 	
  

 	
 Mary Bauman
 (Neuro IP)

 

Page 1 of 8

	
  

 	
  

 
	
 MEDTRONIC
 CONFIDENTIAL DOCUMENT

 	
 SCHEDULE A 

 

TRANSITION SERVICES ACTIVITIES 

	
  

 	
  

 	
  

 
	
 Definitions:

 	
  

 
	
  

 	
 • 

 	
 “Closing”
 means the Effective Date of the TSSA. 

 
	
  

 	
  •

 	
 “Initial
 Term” has the definition set forth in the TSSA. 

 
	
  

 	
  •

 	
 “Legal
 Manufacturer” means the party registered with the FDA as the manufacturer of
 the Product, which coincides with the US Regulatory Transfer. 

 
	
  

 	
  •

 	
 “License
 Agreement” means the License Agreement between Licensor and Licensee dated
 September 6, 2011. 

 
	
  

 	
  •

 	
 “Licensor”
 means Medtronic, Inc, 

 
	
  

 	
  •

 	
 “Licensee”
 means Urologix, Inc. 

 
	
  

 	
  •

 	
 “Product(s)”
 has the definition set forth in the License Agreement. 

 
	
  

 	
  •

 	
 “TSSA”
 means the Transition Services and Supply Agreement between Licensor and
 Licensee dated September 6, 2011. 

 

	
  

 	
  

 	
  

 
	
 A. Marketing, Marketing
 Communication, Sales and Education

 
	
  

 	
 1.          One
 Field Development Manager (FDM) or designate and the core Prostiva RF Therapy
 team (Marketing and Engineering) will give up to two 2-Day training sessions
 to the group of Licensee’s designated trainers (a “Train the Trainer”
 session) in Minneapolis. If Licensee prefers an alternate site, Licensee is
 responsible for all travel expenses. The training will be hands on, including
 demonstration as well as performance by Licensee personnel. Licensee will
 assign a group of “trainers” to attend this event. This activity will be
 provided within the first 60 days after the Closing. 

 
	
  

 	
  

 
	
  

 	
  

 	
 Additionally,
 during the 90 days after the Closing, one Prostiva marketing team member and
 one FDM (or designate) will be available to give up to 3 one-day overview
 sessions of Prostiva to all required personnel at Licensee’s designated US
 location, with out-of-pocket travel expenses of the Licensor’s
 representative(s) covered by Licensee. This overview will include explaining
 the therapy indication, diagnosis, components of the product, the procedure,
 and interpretation of the results. Licensor will transfer digital content and
 hard copies of all training materials to Licensee within 15 days after the
 Closing.

 
	
  

 	
  

 	
  

 
	
  

 	
 2.          Marketing
 and Sales Materials: Licensor will compile a binder to send to Licensee
 within one (1) week of the Closing that will include current marketing
 materials including vanity URLs, pricing and reimbursement information, sales
 process flows, customer call management plans and an approved list of
 clinical support articles. The remaining stock of produced promotion material
 specific to Prostiva will be shipped to the Licensee within 30 days after the
 Closing. Licensee is entitled to use such material until Licensee becomes the
 Legal Manufacturer of the Products. Licensee will have the right to
 incorporate copy and content of promotional material into new material with
 Licensee’s labeling, excluding the use of patient testimonials without the
 patient’s prior written consent, in accordance with the terms of the TSSA and
 License Agreement. Electronic copies of the materials will also be provided
 as available but in no event later than thirty (30) days after the Closing.
 To the extent possible, Licensor will provide existing materials used for
 trade shows. Licensee shall be entitled to use existing 

 

Page 2 of 8

	
  

 	
  

 
	
 MEDTRONIC CONFIDENTIAL
 DOCUMENT

 	
 SCHEDULE
 A 

 

	
  

 	
  

 
	
  

 	
 audiovisual
 and other promotion material where Licensor’s name and logotype are embedded
 in the material until Licensee revises or edits such material or decides that
 a specific marketing tool is obsolete, but in all such cases Licensee shall
 make clear that the Products are sold by Licensee under license from
 Licensor.

 
	
  

 	
  

 
	
  

 	
 3.       At
 the Closing, or as soon as practical after the Closing, Licensor will
 redirect Licensor’s website visitors for the Products to Licensee’s
 designated website, and Licensor will take all necessary steps to transfer
 registration of the following domains to Licensee: 

 

	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 a.

 	
 Vidamed.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 b.

 	
 Prostiva.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 c.

 	
 takecontrolofyourflow.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 d.

 	
 getoffyourmeds.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 e.

 	
 getoutofthebathroom.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 f.

 	
 beat-bph.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 g.

 	
 bphtreatment.com 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 h.

 	
 helpmyprostate.com 

 

	
  

 	
  

 	
  

 
	
  

 	
  

 	
 As
 soon as practical, Licensor will take all necessary steps to transfer
 Prostiva — related website content from Licensor’s website
 (www.medtronic.com) and the above-listed websites to Licensee. Licensor will
 maintain links from its website to Licensee’s designated website for 6 months
 after the Closing.

 
	
  

 	
  

 	
  

 
	
  

 	
 4.       Licensor
 will provide to Licensee in electronic format the United States customer
 lists with purchasing history for the past three (3) years, as well as quote
 standards, any outstanding quotes, current contract, rebate processes and
 price lists at the Closing. 

 
	
  

 	
  

 
	
  

 	
 5.

 	
 Licensor
 will provide Licensee the most recent forecasts for the Licensor’s fiscal
 year. 

 
	
  

 	
  

 	
  

 
	
  

 	
 6.

 	
 The
 parties will mutually prepare and agree upon a formalized communication plan,
 including formal press release plans (to be approved by Licensor and
 Licensee), and formal communication to customers. 

 
	
  

 	
  

 	
  

 
	
 B.
 Healthcare Economics and Reimbursement Services

 
	
  

 	
 Within
 30 days of the Closing, Licensor will provide:

 
	
  

 	
  

 
	
  

 	
 1.

 	
 Coding
 and payment status requirements. 

 
	
  

 	
 2.

 	
 List
 of issues and common questions from customers. 

 
	
  

 	
 3.

 	
 List
 of previously used, but outdated customer materials.

 

Page 3 of 8

	
  

 	
  

 
	
 MEDTRONIC CONFIDENTIAL
 DOCUMENT

 	
 SCHEDULE
 A 

 

	
  

 	
  

 
	
  

 	
 4.          Current
 payor coverage status. 

 
	
  

 	
 5.          Licensee
 will provide to Licensor the contact information of Licensee staff for
 customer referrals regarding coding, coverage or payment questions. 

 
	
  

 	
  

 
	
 C.
 Regulatory Transition Services

 
	
  

 
	
  

 	
 1.          Regulatory
 Plan (Schedule C to the TSSA) contains details related to the transition
 requirements and current geography approval/status. 

 
	
  

 	
  

 
	
  

 	
 2.          Licensor
 and Licensee will complete the 510(k) Work and Regulatory Transfer as set
 forth in the TSSA and the Regulatory Plan. During the Initial Term, Licensor
 will transition all the related regulatory documentation to Licensee,
 including but not limited to the Product Technical File as defined below,
 product change files, device registration files, licenses, regulating body
 agreements/correspondence, and product regulatory files including any
 clinical results. Notwithstanding the foregoing, documents with original
 signatures will be provided as copies, and originals will be transferred when
 regulatory certificates are issued in Licensee’s name. The details of the
 transition will be covered in the Regulatory Plan. 

 
	
  

 	
  

 
	
  

 	
 3.          Licensor
 will provide Licensee within thirty (30) days of Closing the current
 electronic copy of the technical file and supporting documents referenced in
 Conformity Assessments and SAM for each model (the “Product Technical File”)
 and labeling to initiate product re-labeling/re-branding, CE mark transfer
 and design certificate transfer to the Licensee’s Notified Body. 

 
	
  

 	
  

 
	
  

 	
 4.          After
 the US Regulatory Transfer, Licensor will provide up to forty (40) hours of
 additional consultation at no cost to Licensee during the Initial Term. 

 
	
  

 	
  

 
	
  

 	
 5.          Licensor
 shall remain responsible for a regulatory body audits that may occur before
 the date Licensee becomes the Legal Manufacturer of the Products. Licensee
 will cooperate with Licensor to facilitate any audits. 

 
	
  

 	
  

 
	
 D.
 Quality Assurance & Quality Management System
Key
 assumptions:

 
	
  

 
	
  

 	
 1.          After
 Licensee completes training provided by Licensor specified in Section F,
 Licensor will complete an audit of Licensee’s QMS (“Quality Audit”) as it
 relates to post market surveillance prior to transferring those activities to
 Licensee as outlined in the Quality Agreement (Schedule D to the TSSA). 

 
	
  

 	
  

 
	
  

 	
 2.          Licensee
 will distribute Licensor’s branded Products in accordance with the TSSA,
 Interim Distribution Agreement and Quality Agreement (Schedule B and D). All
 products labeled with Licensor’s brand will be processed through Licensor’s
 quality system and distribution center, and then transferred to Licensee’s
 designated distribution center. 

 
	
  

 	
  

 
	
  

 	
 3.          The
 post market surveillance activities listed in Section F and G, including
 technical service, complaint handling, Product and supplier quality monitoring,
 returned product analysis, and servicing/repair management, for Licensor
 branded Products will 

 

Page 4 of 8

	
  

 	
  

 
	
 MEDTRONIC CONFIDENTIAL
 DOCUMENT

 	
 SCHEDULE
 A 

 

	
  

 	
  

 
	
  

 	
 continue
 to be primarily supported by Licensor until Licensee becomes the Legal Manufacturer
 of the Prostiva Product, at which time Licensee will assume primary
 responsibilities for the post market surveillance activities listed in
 Section F. The parties will cooperate to facilite the timing of the knowledge
 transfer of post market surveillance activities in conjunction with the
 expected completion of the 510(k) Work. Unless specified in this Plan or the
 TSSA, Licensor’s responsibilities and services will terminate at the end of
 the Initial Term. Licensee will provide required information under Section
 4.1(f) of the TSSA for facilitation Licensor’s regulatory reporting
 requirements.

 
	
  

 	
  

 
	
  

 	
 4.          Licensor
 will manage all communications with Licensor’s notified body and Licensee
 will manage all communications with Licensee’s notified body, including any
 required audits related to the Product Technical File transfer. 

 
	
  

 	
  

 
	
  

 	
 5.          Licensor
 and Licensee will agree upon a joint communication to Prostiva customers
 outlining the order/entry, order fulfillment, technical services and post
 market surveillance transition timeline. 

 
	
  

 	
  

 
	
  

 	
 6.          Licensor
 may audit Licensee’s compliance and fulfillment of the outsourced post market
 surveillance activities as described in the Quality Agreement and the Interim
 Distribution Agreement, and/or the verification of re-branding/re-labeling
 activities completed by Licensee no more than 3 times during the 18 months
 following the Closing. 

 

	
  

 	
  

 	
  

 
	
 Quality
 Transition Services:

 
	
  

 	
 Licensor
 will provide all documentation described below in the order of preference of,
 and only when available, an editable electronic file, in a non-editable
 electronic file format and lastly in paper copy if neither of the other 2
 forms are available. In the event some documents described below are not
 available at time of closing and are provided by Bovie as part of the
 termination of the Bovie Agreement, Licensor will provide Licensee a copy of
 such documents within 60 days of Licensor’s receipt thereof.

 
	
  

 	
  

 	
  

 
	
  

 	
 7.          Licensor
 will provide Licensee with electronic files of the current Product Technical
 File and the available editable files (Adobe FrameMaker, etc) of the current
 Prostiva labeling within thirty (30) days of the Closing. 

 
	
  

 	
  

 
	
  

 	
 8.          Licensor
 will provide Licensee with electronic copies of all TUNA and Prostiva related
 DHFs including the approved and editable files for any historical versions
 during the Initial Term. 

 
	
  

 	
  

 
	
  

 	
 9.          Licensor
 will provide Licensee with electronic copies of both the approved and
 available editable files (3D cad, Word, Excel, etc.) of DMR documentation
 maintained by the Licensor during the Initial Term. 

 
	
  

 	
  

 
	
  

 	
 10.        Licensor
 will provide Licensee with copies of applicable QMS records such as CAPAs,
 complaint records, MDRs, Vigilance Reports and servicing records during the Initial
 Term.

 

Page 5 of 8

	
  

 	
  

 
	
 MEDTRONIC CONFIDENTIAL
 DOCUMENT

 	
 SCHEDULE
 A 

 

	
  

 	
  

 	
  

 
	
  

 	
 11.          Licensor’s
 historical DHRs still in its possession will be made available to the
 Licensee upon reasonable request (for ex: governmental investigation or
 litigation).

 
	
  

 	
  

 
	
  

 	
 12.          Licensor
 will provide Licensee with access to paper Vidamed files, based on Licensor’s
 file summary. Any paper Vidamed files Licensee does not take will be
 destroyed at the discretion of Licensor.

 
	
  

 	
  

 
	
  

 	
 13.          Additional
 consultation requested by Licensee in excess of time required for completion
 of items 1-12 in this Section D will be available from Licensor at no charge
 through the Initial Termin an amount not to exceed twenty (20) hours.

 
	
  

 	
  

 
	
 E.
 Supply Chain Management

 
	
  

 	
 1.          Licensor
 will provide Licensee with originals or copies of all major tier 1 supply
 agreements, supplier quality agreements, supplier metrics, supplier audit
 records and current inventory levels for both finished goods and components. 

 
	
  

 	
  

 
	
  

 	
 2.          Licensee
 and Licensor will agree to a date by which to notify all suppliers that they
 can no longer produce product with Licensor’s brand, in accordance with the
 Quality Agreement. 

 
	
  

 	
  

 
	
  

 	
 3.          SCARs,
 supplier metrics, supplier initiatives, etc. will be provided to the Licensee
 during the Initial Term. 

 
	
  

 	
  

 
	
  

 	
 4.          Additional
 Supplier quality consultation/training in excess of time required for
 completion of items 1-3 in this Section E requested by Licensee will be
 available from Licensor at no charge through the Initial Term in an amount
 not to exceed twenty (20) hours. 

 
	
  

 	
  

 
	
 F.
 Post Market Surveillance

 
	
  

 	
 Technical
 Service/Customer Support Transition Services:

 
	
  

 	
 1.          Licensor
 will provide technical service and customer support during the Initial Term
 as set forth below. 

 
	
  

 	
  

 
	
  

 	
 2.          Prior
 to Closing, Licensee and Licensor will agree upon and execute a plan to
 inform and train Licensor’s customer service and technical service groups in
 the proper handling of customer calls relating to the transaction. At
 Closing, customer order calls will be routed to Licensee for processing. 

 
	
  

 	
  

 
	
  

 	
 3.          Licensor
 will provide technical service and customer support training as part of the
 Continuation Engineering Support training described in Section G below. 

 
	
  

 	
  

 
	
  

 	
 4.          Training
 must be completed prior to the transition dates outlined in the customer
 communication from D.5 above. Once the training is complete, Licensor will
 start routing the calls to a location specified by Licensee. Licensor’s
 technical service/customer support staff will be available for same-business
 day or next-business day call assistance (i.e.; teleconferenced in, etc.) for
 the remainder of the Initial Term in an amount not to exceed sixteen (16)
 hours. 

 

Page 6 of 8

	
  

 	
  

 
	
 MEDTRONIC CONFIDENTIAL
 DOCUMENT

 	
 SCHEDULE
 A 

 

	
  

 	
  

 	
  

 
	
  

 	
 5.          Licensor
 will provide copies of all technical service documentation (tech notes,
 training materials, and any other customer-related information, etc.) to
 Licensee during the Initial Term. 

 
	
  

 	
  

 
	
  

 	
 Returned
 Product Analysis & Repair Transition Services:

 
	
  

 	
  

 
	
  

 	
 6.          Licensor
 will handle returned product analysis and repairs as specified in Section D.3
 and the TSSA and otherwise provide the services set forth below during the
 Initial Term. 

 
	
  

 	
  

 
	
  

 	
 7.          Licensor
 will maintain a forwarding address for a minimum of two (2) years following
 the Closing and will forward any returned product to a U.S. address
 designated by Licensee. 

 
	
  

 	
  

 
	
  

 	
 8.          Licensor
 will provide up to one (1) week of returned product analysis and repair
 training for several qualified Licensee employees at Licensor’s facility
 (Minneapolis). The “hands-on” training will include a knowledge transfer on
 returned product analysis. 

 
	
  

 	
  

 
	
  

 	
 9.          After
 US Regulatoy Transfer, Licensor will start routing the returned product to a
 location specified by Licensee. Licensor’s returned product support staff
 will be available for assistance at no charge for the remainder of the
 Initial Term in an amount not to exceed twenty-four (24) hours; however
 Licensor’s personnel will be reassigned and hence 24 - 48 hours may be needed
 by Licensor to provide the consult. 

 
	
  

 	
  

 
	
  

 	
 10.        Licensor
 will provide copies of all returned product and repair procedures as part of
 the DMR transfer during the Initial Term.

 
	
  

 	
  

 
	
  

 	
 11.        Licensor
 will ship redundant analysis and repair equipment to Licensee’s designated US
 address after the training in F.8.

 
	
  

 	
  

 
	
  

 	
 Complaint
 Handling and Regulatory Reporting Transition Services:

 
	
  

 	
  

 
	
  

 	
 12.        Licensor
 will handle complaints, analysis, trending and regulatory reporting until the
 date Licensee becomes the Legal Manufacturer of the Products and otherwise
 provide the services set forth below until that time. After the US Regulatory
 Transfer, new complaints will be transferred to and become the responsibility
 of the Licensee. The Parties agree that until the US Regulatory Transfer
 Licensor will use commercially reasonable efforts to close existing
 complaints and returned product analysis files with the goal (not the
 obligation) to close them within this period and not transfer open files to
 the Licensee.

 
	
  

 	
  

 
	
  

 	
 13.        During
 the remainder of the Initial Term Licensor’s complaint handling and
 regulatory reporting staff will be available at no charge for consultation in
 the amount not to exceed sixteen (16) hours; however Licensor’s personnel
 will be reassigned, and hence 24 - 48 hours may be needed by Licensor to
 provide the consult.

 

Page 7 of 8

	
  

 	
  

 
	
 MEDTRONIC CONFIDENTIAL
 DOCUMENT

 	
 SCHEDULE
 A 

 

	
  

 	
  

 
	
 G. Product-Level
 Continuation Engineering Support

 
	
  

 	
 1.          Licensor
 will provide up to eighty (80) hours of initial product training for
 qualified Licensee employees at Licensor’s facility in conjunction of the
 expected timeline of completing the 510(k) Work. This “hands-on” training
 will include a knowledge transfer of: current engineering projects,
 current/historical CAPAs, current supplier and value engineering initiatives,
 software/system architecture knowledge, manufacturing process, design and
 product history, product opportunities, customer service trouble shooting
 etc. Licensee will pay for its employees’ travel costs and, if necessary,
 Licensors’ employee travel costs to Licensee’s facilities. After the US
 Regulatory Transfer, Licensee will be primarily responsible for continuation
 engineering activities, including effecting design changes. 

 
	
  

 	
  

 
	
  

 	
 2.          Once
 this initial training is complete, Licensor’s product engineering staff will
 be available at no charge for assistance through the Initial Term, up to
 forty (40) additional hours. 

 
	
  

 	
  

 
	
  

 	
 3.          Any
 product engineering support consultation requested by Licensee after the
 Initial Term will be at Licensor’s discretion and charged to Licensee at an
 agreed upon hourly rate plus any additional out-of-pocket travel costs. 

 

Page 8 of 8

Schedule B

Interim Distribution Agreement

See attached.

SCHEDULE B 

Terms of Distribution

	
  

 
	
 Distributor
 = Licensee 

 
	
 Principal
 = Licensor

 
	
 Products
 = Products as defined in the Transition Services and Supply Agreement (the
 “Agreement”) but only those with the Licensor’s label

 
	
 Territory
 and Term = As provided in Article 3 of the Agreement

 
	
  

 
	
           1.          No
 Modification of Products. Except as otherwise permitted under the
 Transition Services and Supply Agreement or to meet requirements to add a
 label identifying the Distributor, Distributor shall under no circumstances
 modify, repackage, encase, insert any other product into, combine as a unit
 with any other product, adulterate, misbrand, alter or add labels to or
 remove labels from any Product, whether for purpose of display or sale. 

 
	
  

 
	
           2.          Product
 Warranty or Representations. Distributor shall make no false or
 misleading representations or warranties of performance, efficiency, or otherwise
 for any of the Products, except for those warranties provided by Principal to
 customers prior to the Effective Date or as otherwise approved of in writing
 by Principal. Further, Distributor shall make no warranties of performance,
 efficiency, or otherwise, which binds Principal in any way, or hold itself
 out as having any rights not expressly granted herein. 

 
	
  

 
	
           3.          Compliance
 with Applicable Law. In performing its obligations hereunder Distributor
 shall comply with any law or regulation applicable to it or to its activity
 of purchasing Products from Principal, importing Products into the Territory,
 and marketing and reselling Products in the Territory (collectively, the
 “Applicable Laws”). Moreover, Distributor shall not perform its obligations
 hereunder in a manner that would cause Principal to not be in compliance with
 any Applicable Law of the Territory or of the United States of America
 (including, without limitation, U.S. laws and regulations governing exports
 and the Foreign Corrupt Practices Act). 

 
	
  

 
	
           4.          Record
 Keeping. Distributor shall maintain all records regarding sales and
 traceability of Products as required by Applicable Law. More specifically,
 Distributor shall maintain traceability records and a Product tracking system
 throughout the duration of this Agreement, and shall keep such records
 available for inspection or use by Principal. The tracking system shall
 record or allow to retrieve: (i) Product information as needed to comply with
 all legal requirements applicable at the time of resale of such Product by
 Distributor, including information on all parties involved in the Product’s
 chain of distribution and its end user; and (ii) information on such Product
 performance and safety record. 

 
	
  

 
	
           5.          Product
 Labeling and Information. Distributor shall ensure at all times that
 Products are accompanied by labeling, instructions for use and other relevant
 Product information documentation in the language required by applicable law
 in the country where the Product is to be used. 

 
	
  

 
	
           6.          Product
 Recalls, Field Actions. In the event Principal deems it necessary to
 recall any Product or to implement any other form of field corrective action
 concerning Products, or if any governmental authority requests such recall or
 implementation, Principal and Distributor 

 

1

 SCHEDULE B 

	
  

 	
  

 	
  

 
	
 shall
 cooperate fully with each other in performing such recall or implementation
 program. Costs and expenses of the program, including without limitation
 expenses or obligations to third parties, costs of notifying customers and
 costs associated with the shipment of such Products from customers will be
 divided as specified under the Agreement.

 
	
  

 
	
  

 	
 7.          Commercial
 Policy. 

 
	
  

 	
  

 
	
  

 	
             (a)          Each
 of the parties hereto warrants that it shall not, directly or indirectly pay,
 offer to pay, promise to pay or authorize payment of, or give, offer to give,
 promise to give or authorize the giving of, any money or thing of value to
 any government official, customer or person in the knowledge that all or a
 portion of such money or thing of value shall be offered, given or promised,
 directly or indirectly, to a government official, customer or person for the
 purpose of corruptly influencing any act or decision of such government
 official, customer or person, including a decision to fail to perform his or
 her lawful duty, or inducing such government official, customer or person to
 use influence on any governmental authority or customer to corruptly affect
 or influence any act or decision of such governmental authority in order to
 assist Principal or Distributor in connection with the use or sale of the
 Products.

 
	
  

 	
  

 
	
  

 	
             (b)          Principal
 and Distributor hereby represent, warrant and covenant as follows: 

 
	
  

 	
  

 
	
  

 	
  

 	
                  (i)          Each
 has been and will continue to conduct business in material compliance with
 all Applicable Laws, including but not limited to the Social Security Act, 42
 U.S.C. et seq, including the anti-kickback provisions of 42 U.S.C.§
 1320a-7b(b); the False Claims Act, 31 U.S.C. 3729 et seq. and the public transparency and disclosure laws of
 42 U.S.C. Section 1320a-7h. Each possesses, and is in compliance with (except
 for such noncompliance as would not have a material adverse effect on its
 business), all licenses, permits, approvals and other governmental
 authorizations necessary to conduct its business; 

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
                  (ii)         Each
 will comply with Principal’s Business Conduct Policy (“BCP”) for activities
 in the United States and Principal’s Global Anti-Corruption Policy for
 activities outside of the United States (“GACP”) governing relationships with
 health care professionals and other “Customers” as defined therein, and
 Foreign Officials and others under the scope of the GACP, as the same may be
 amended from time to time, upon notice of any such amendment by Principal.
 Distributor acknowledges having received from Principal a copy of Principal’s
 BCP and of the GACP, and that Principal’s BCP are available at all times on
 Principal’s public web site at: http://www.medtronic.com/corporate
 governance/principles-and-ethics/us-business-conduct-standards/index.htm.
 Distributor agrees to receive from Principal training on Principal’s BCP and
 of the GACP and how they apply in connection with Distributor’ activities
 related to the marketing and sales of Products. Distributor, in all of its
 efforts and activities under this Agreement, agrees that it will not do
 anything inconsistent with the BCP or the GACP in any activities connected
 herewith.

 

2

 SCHEDULE B 

	
  

 	
  

 	
  

 
	
  

 	
  

 	
                  (iii)         Each
 has complied and will continue to comply with all applicable third party
 payor billing policies, procedures, limitations and restrictions; and there
 is no pending or, to its knowledge, threatened recoupment or penalty action
 or proceeding against it under governmental programs (including without
 limitation Medicare or Medicaid) or by any other third party payor;

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
                  (iv)         Neither
 Principal nor Distributor, nor any of either’s respective officers,
 directors, agents, or managing employees, has been excluded or is a party to
 an action for exclusion from participation in federal or state health care
 programs pursuant to §1128 of the Social Security Act, 42 U.S.C. §1320a-7, or
 related regulations or other federal or state laws and regulations; and

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
                  (v)         Distributor
 acknowledges that any coding and billing information provided to Distributor
 by Principal is for Distributor’s convenience only. Distributor agrees that
 it remains solely responsible to determine applicable coverage and to submit
 appropriate and accurate codes, modifiers and charges to third party payors
 for Distributor products, notwithstanding any coding and billing information
 provided to Distributor from Principal. Notwithstanding any other provision
 herein, Distributor agrees to hold Principal and its affiliates harmless
 from, and covenants not to sue Principal or its affiliates for any claim
 related to, Principal’s provision of coding and billing information to
 Distributor, including without limitation for negligence in relation to such
 information.

 
	
  

 	
  

 	
  

 
	
  

 	
           (c)          Distributor
 acknowledges that its failure to observe strictly these terms and conditions
 may subject Principal’s and its affiliates’ employees, agents and
 representatives to substantial fines, penalties, damages, expenses, the
 imposition of additional taxes or the loss of tax deductions, the loss of
 business opportunities, including those which are sought in connection
 herewith, and other consequential losses, damages and expenses.

 
	
  

 	
  

 
	
           8.       Certain
U.S. Laws and Regulations. Distributor acknowledges that Principal has
informed Distributor that United States law and regulations may under certain
circumstances forbid or limit the re-export of Products (or associated
technical data) sold or transferred to customers in the Territory.
Distributor undertakes to make every reasonable effort to comply with such
laws and regulations, including, without limitation, providing customer
information required by Principal to comply with Applicable Law of the U.S.  

 
	
  

 	
  

 
	
           9.       Conflicts.
These Terms of Distribution are expressly subject to the limitations of
liability and remedies and disclaimers of the Agreement. If there is a
conflict between the provisions of the Terms of Distribution and the
Agreement, the terms of the Agreement shall take precedence.  

 

3

Schedule C

Regulatory Transition Plan

See attached.  

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
 Medtronic

 Neuromodulation

 Confidential

 	
 Document

 Number

 	
 Ver/Rev

 2.0

 	
 Page 1

 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

Project Name: Regulatory Plan

Prostiva® RF Therapy System Transfer to Urologix 

Authored By: Tom Reichel and Andrea Rasmussen

	
  

 	
  

 
	
 Version/Revision History:

 
	
 Version

 	
 Description of Change

 
	
 1.0

 	
 Initial draft

 
	
 2.0

 	
 Initial release into NPD system (must start at revision 2)

 
	
  

 	
  

 
	
  

 	
  

 

Note: This
regulatory plan represents our best current plans based on current knowledge.
As a working document, it is anticipated that this plan will evolve as more
information becomes available. 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
 Medtronic

 Neuromodulation

 Confidential

 	
 Document

 Number

 	
 Ver/Rev

 2.0

 	
 Page 2

 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

	
  

 	
  

 	
  

 
	
 1.

 	
 Overview 

 
	
  

 	
 This
 document outlines a regulatory plan intended to support Medtronic corporate
 commercial release requirements and worldwide regulatory requirements for the
 transfer of the Prostiva® RF Therapy (Prostiva) business and products to
 Urologix. 

 
	
  

 	
  

 
	
 2.

 	
 Scope 

 
	
  

 	
 The intent
 of this regulatory plan is to identify current regulatory approvals and
 summarize those tasks required to continue marketing Prostiva products and
 accessories into existing geographies after the close of the agreement and
 through the relabeling process. The following products/accessories are
 included in the Prostiva therapy system: 

 
	
  

 	
  

 
	
  

 	
 •

 	
 Model 8930
 Prostiva RF Generator 

 
	
  

 	
 •

 	
 Model 8929
 Prostiva RF Therapy Hand Piece Kit including: 

 
	
  

 	
 •

 	
 Model 6101*
 Tubing System (not sold separately) 

 
	
  

 	
 •

 	
 Model 8934
 Return Electrode (not sold separately) 

 
	
  

 	
 •

 	
 Model 8099*
 Telescope (0° angle of view) 

 
	
  

 	
 •

 	
 Model 8099TU15
 Telescope (15° angle of view) 

 
	
  

 	
 •

 	
 Model 60883
 Footswitch (this item is an off-the-shelf accessory) 

 
	
  

 	
  

 	
  

 
	
  

 	
 *Note: There
 are instances in Medtronic documentation where Model 6101 is referred to as
 Model 6101(TU) and Model 8099 is referred to as Model 8099TU. The labeled
 product model number and model number in the US regulatory documentation is
 the number without the “TU” suffix. 

 
	
  

 	
  

 
	
 3.

 	
 Current PROSTIVA Registrations/Approvals 

 
	
  

 	
 Table 1
 lists those countries or geographies that have regulatory approval to market
 certain products/accessories of the Prostiva RF Therapy System, The model
 numbers of the products that have approval are listed for that country or
 geography. 

 

Table 1: Global Status of Prostiva Approvals

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 Geography/

 Country

 	
 Current models that

 Have Country

 Regulatory Approval

 	
 License

 	
 Comments

 
 (Document license holder if

 different then Medtronic)

 
	
 Australia

 	
 8929,
 8930, 8099,

 8099TU15, & 60883

 	
 8099

 8929

 8930

 60883

 8099TU15

 	
 AUST I 136825

 AUST I 138134

 AUST I 137006

 AUST I 136836

 AUST I 136825

 	
  [***]

 
	
 Canada

 	
 60883

 	
 60883

 	
 64122_2004/04/05

 	
  [***]

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
 Medtronic

 Neuromodulation

 Confidential

 	
 Document

 Number

 	
 Ver/Rev

 2.0

 	
 Page 3

 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 Geography/

 Country

 	
 Current models that

 Have Country

 Regulatory Approval

 	
 License

 	
 Comments

 
 (Document license holder if

 different then Medtronic)

 
	
 Costa
 Rica

 	
 8929

 	
 1005-EMB-8208

 	
  [***]

 
	
 EU

 	
 8929,
 8920, 8099, &

 60883.

 	
 6101

 

 8099

 

 8929

 

 8930

 

 8934

 

 60883

 	
 G2S 10 05 39709

 647_06/30/2010

 Q1N 10 05 39709

 646_07/01/2010

 G1 10 05 3970

 645_06/30/2010

 G1 10 05 39709

 645_06/30/2010

 11N 10 05 39709

 646_07/01/2010

 G1 09 06 39709

 604_06/05/2009

 	
  [***]

 
	
 Mexico

 	
 8929,
 8930, 8099 &

 60883

 	
 8099

 8929

 8930

 60883

 8934

 6101

 	
 1261E2006SSA

 1176E2006 SSA

 1261E2006SSA

 1261E2006SSA

 1176E2006 SSA

 1176E2006 SSA

 	
  [***]

 
	
 New
 Zealand

 	
 8929,
 8930, 8099,

 8099TU15, & 60883

 	
 8099

 8929

 8930

 60883

 8099TU15

 	
 77TA2D

 77T9ZE

 77TA29

 77TA2B

 77TA2D

 	
  [***]

 
	
 Singapore

 	
 8929,
 8930, 8099,

 8099TU15, & 60883

 	
 6101

 8099

 8929

 8930

 8934

 60883

 8099TU15

 	
 DE0003918

 DE0003918

 DE0003918

 DE0003918

 DE0003918

 DE0003918

 DE0003918

 	
  [***]

 
	
 South
 Korea

 	
 8929,
 8930, 8099, , &

 60883

 	
 8099

 8929

 8930

 8934

 6101

 60883

 	
 PA04-703_2004/06/07

 PA09-938_2009/09/18

 PA08-97_2008/01/29

 PA09-938_2009/09/18

 PA04-703_2004/06/07

 PA08-97_2008/01/29

 	
  [***]

 
	
 United
 States

 	
 8929,
 8930, 8099, &

 60883. Model

 8099TU15 is marketed,

 but has not been

 communicated to FDA.

 	
 8099

 8929

 8934

 8930

 6101

 8099 /

 8099TU15

 	
 K101139

 K052413

 K052413

 K052413

 K002583

 K002583

 	
  [***]

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
 Medtronic

 Neuromodulation

 Confidential

 	
 Document

 Number

 	
 Ver/Rev

 2.0

 	
 Page 4

 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 Geography/

 Country

 	
 Current models that

 Have Country

 Regulatory Approval

 	
 License

 	
 Comments

 
 (Document license holder if

 different then Medtronic)

 
	
  

 	
  

 	
  

 	
  

 

	
  

 	
  

 	
  

 
	
  

 	
 [* * *]

 
	
  

 	
  

 
	
 4.

 	
 US and EU status of Prostiva System Components 

 
	
  

 	
  

 
	
  

 	
 4.1

 	
 US Status

 
	
  

 	
  

 	
 The Prostiva
 RF Therapy system is considered a Class II medical device and meets the
 premarket notification requirements under section 510(k) of the US FD&C
 Act. Table 2 lists the Prostiva RF Therapy system models and the
 corresponding 510k submission that obtained clearance for the currently
 marketed product. 

 

Table 2: Approval Status in the Unites Stales

	
  

 	
  

 	
  

 
	
 Current Model

 	
 Clearing

 501K

 	
 Comments

 
	
 8929

 	
 K101139

 	
  [* * *] 

 
	
 60883

 	
 K052413

 	
  [* * *] 

 
	
 8924

 	
 K052413

 	
  [* * *] 

 
	
 8930

 	
 K052413

 	
  [* * *] 

 
	
 6101

 	
 K002583

 	
  [* * *] 

 
	
 8099
 /

 8099TU15

 	
 K002583

 	
  [* * *] 

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
 Medtronic

 Neuromodulation

 Confidential

 	
 Document

 Number

 	
 Ver/Rev

 2.0

 	
 Page 5

 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

	
  

 	
  

 
	
 4.2

 	
 EU Status

 
	
  

 	
 Table 3
 lists the status of the Prostiva system components according to Annex IX of
 the Medical Device Directive (MDD, 93/42/EEC) 

 

Table 3: Approval Status in the EU

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 Component

 	
 Class

 	
 Rule

 	
 Invasive

 	
 Duration

 
	
 8929

 	
 IIb

 	
 Rule
 9

 	
 Non-invasive

 	
 Transient

 
	
 60883

 	
 IIb

 	
 Rule
 9

 	
 Invasive

 	
 Transient

 
	
 8924

 	
 I

 	
 Rule
 1, Non-sterile

 	
 Non-invasive

 	
 Transient

 
	
 8930

 	
 I

 	
 Rule
 2, Sterile

 	
 Non-invasive

 	
 Transient

 
	
 6101

 	
 IIb

 	
 Rule
 9

 	
 Non-invasive

 	
 Transient

 
	
 8099
 /

 8099TU15

 	
 I

 	
 Rule
 5, Non-sterile

 	
 Non-invasive

 	
 Transient

 

	
  

 	
  

 	
  

 
	
 5.

 	
 Tasks Required to Transfer Brand by Country 

 
	
  

 	
 For a Brand
 change, most markets will be stopped for delivery until the new Brand and its
 products have been properly registered. Therefore, a distribution agreement
 between Medtronic, Inc. and Urologix is required to allow Urologix to
 continue to sell and distribute approved Medtronic-labeled products until
 completion of the 510(k) Work and/or Regulatory Transfer as defined in the
 TSSA when Urologix’s own registrations have been completed. 

 
	
  

 	
  

 
	
  

 	
 Note:
 Normally, a global regulatory plan summarizes input from the geography
 regulatory representatives. Because the divestiture of the Prostiva system
 is, at present, confidential as is the potential transfer to Urologix, much
 of the re-registration into in this plan is oases on the input from the
 geographies for a recent Medtronic product divestiture that was concluded
 within the past 30 months. 

 
	
  

 	
  

 
	
  

 	
 The
 following is necessary for being able to start re-registrations with a new
 company name for those countries dependent on the CE mark: 

 
	
  

 	
  

 
	
  

 	
 •

 	
 An audited
 Quality system in accordance with ISO 13485 

 
	
  

 	
 •

 	
 EC
 certificate (upon successful technical file review and/or ISO audit) 

 
	
  

 	
 •

 	
 Updated
 product labeling 

 
	
  

 	
  

 	
  

 
	
  

 	
 The product
 approvals, registrations or re-registrations in the various geographies (OUS
 and non-EC), in most cases, must be submitted by an in-country
 representative. This is usually the distributor or importer in these countries.
 To the extent that Urologix elects to

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
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 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

	
  

 	
  

 	
  

 
	
  

 	
 use
 Medtronic distributors in these geographies, the in-country Medtronic
 Regulatory Specialists can assist in those registrations. 

 
	
  

 	
  

 
	
  

 	
 Table 3
 below, summarizes those tasks and approximate timing for notifying or
 re-registering the Prostiva system in the geographies/countries where it is
 currently approved. 

 

Table 5-1: Re-registration Timing and Tasks

	
  

 	
  

 	
  

 	
  

 
	
 Geography/Country

 	
 Time for Re-

 registration1

 	
 Tasks2

 	
 Notes

 
	
 Singapore

 	
  [* * *] 

 	
     ●  [* * *] 

 	
  

 
	
 Australia/New
 Zealand

 	
  [* * *] 

 	
     ●  [* * *] 

 	
  

 
	
 EU

 	
  [* * *] 

 	
     ●  [* * *] 

 	
  [* * *] 

 
	
 Mexico

 	
  [* * *] 

 	
     ●  [* * *] 

 	
  

 
	
 South
 Korea

 	
  [* * *] 

 	
     ●  [* * *] 

 	
  

 
	
 United
 States

 	
  [* * *] 

 	
     ●  [* * *] 

 	
  [* * *] 

 

	
  

 	
  

 	
  

 
	
 6.

 	
 Transferable Regulatory Documents 

 
	
  

 	
  

 
	
  

 	
 Note: Copies
 of regulatory documents will be made available to the Buyer during the
 transition period. Originals must be maintained by Medtronic as long as
 product is being manufactured by Medtronic under the Medtronic label.
 Original documents will be made available to Urologix as necessary for
 Regulatory Transfer but will remain owned and controlled by Medtronic until
 specified in the Related Agreements. 

 
	
  

 	
  

 
	
  

 	
 6.1

 	
 US

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
 The
 following Medtronic 510(k) submissions K101139, K082464 and K052413, as well
 as the 510(k) submissions of predicate devices that preceded Medtronic’s
 submissions, serve as the basis for regulatory approval in the United States.
 Historical regulatory submissions for the predicate TUNA devices will be
 transferred as well. 

 

	
  

 

1 Based on UDx, GDx, NDx and BRAVO PCN feedback 

2 A submission to a country generally cannot
be made until the new labeling is available. Thus, there is very little overlap
between the relabeling and submission activities. 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
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 Neuromodulation

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 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

	
  

 	
  

 	
  

 
	
  

 	
 6.2

 	
 EU

 
	
  

 	
  

 	
  

 
	
  

 	
  

 	
 The Prostiva
 Technical File consists of two components: The Prostiva System Conformity
 Assessment and the Prostiva System Standards Assessment. Both of these
 documents reference additional documentation in the Design History File (DHF)
 and Device Master Record (DMR). 

 
	
  

 	
  

 	
  

 
	
 6.3

 	
 Other 

 
	
  

 	
  

 
	
  

 	
 Medtronic,
 Inc. will request the transfer of any and all documentation related to
 registrations/approvals and permits that can be legally transferred in the
 geographies to Urologix. 

 
	
  

 	
  

 
	
 6.4

 	
 Translations 

 
	
  

 	
  

 
	
  

 	
 Medtronic,
 Inc. will provide current manual translations in the following languages: 

 

	
  

 	
  

 
	
 English

 	
 French

 
	
  

 	
  

 
	
 Portuguese

 	
 Spanish

 
	
  

 	
  

 
	
 Swedish

 	
 Dutch

 
	
  

 	
  

 
	
 Finish

 	
 German

 
	
  

 	
  

 
	
 Danish

 	
 Italian

 
	
  

 	
  

 
	
 Greek

 	
  

 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
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 Neuromodulation

 Confidential

 	
 Document

 Number

 	
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 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

Exhibit 1: FDA Clearance Letter (K101139)

 [* * *] 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
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 Neuromodulation

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 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

Exhibit 2: FDA Clearance Letter (K052413)

 [* * *] 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
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 Neuromodulation

 Confidential

 	
 Document

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 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

Exhibit 3: Information from Section 4 of K052413:

 [* * *] 

	
  

 	
  

 	
  

 	
  

 	
  

 
	
 

 	
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 Neuromodulation

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 of 15

 
	
 Title: Regulatory Plan - Prostiva® RF Therapy
 System Transfer to Urologix

 

Exhibit 4: 8099TU15 Regulatory Assessment:

 [* * *] 

Schedule D

Quality Agreement

See attached.

Schedule 2.5

Designated Employees

	
  

 	
  

 
	
 [* * *]

 	
 Sales Rep 1
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 2
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 2
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 2
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 3
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 2
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 3
 - Prostiva

 
	
 [* * *]

 	
 Sales Rep 3 – Prostiva

 

Schedule 4.1(a)

510(k) Work Plan

See attached.  

	
  

 	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
 510k Work Schedule  

 	
  

 	
  

 

[* * *]

Schedule 4.1(f)

Safety Data Contact Lists

	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 
	
 Licensor List of Contact Persons

 
	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 
	
 AREA
OF

SAFETY

INFORMATION

EXCHANGE 

 	
  

 	
  

 	
WHAT 

 	
  

 	
  

 	
WHOM
TO

CONTACT 

 	
  

 	
  

 	
 ADDRESS 

 	
  

 	
  

 	
FAX
NO. 

 	
  

 	
TEL.
NO. 

 	
  

 	
  

 	
E-MAIL 

 
	
 Spontaneous
Reports and General Procedural Issues 

 	
  

 	
  

 	
 Primary reporting AEs and
 general procedural issues

 	
  

 	
  

 	
 [* * *] 

 	
  

 	
  

 	
[* * *] 

 	
  

 	
  

 	
[* * *] 

 	
  

 	
[* * *] 

 	
  

 	
  

 	
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 Secondary liaison for
 reporting AE’s and general procedural issues

 	
  

 	
  

 	
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Affairs and Labeling Changes 

 	
  

 	
  

 	
 Primary liaison for general
 regulatory and labeling issues

 	
  

 	
  

 	
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 Secure email address for receipt of Product Complaints
 information from Licensee

 	
  

 	
  

 	
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 Licensor List of Contact Persons 

 
	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 	
  

 
	
 AREA
OF

SAFETY

INFORMATION

EXCHANGE 

 	
  

 	
  

 	
WHAT 

 	
  

 	
  

 	
WHOM
TO

CONTACT 

 	
  

 	
  

 	
ADDRESS 

 	
  

 	
  

 	
FAX
NO. 

 	
  

 	
TEL.
NO. 

 	
  

 	
  

 	
E-MAIL 

 
	
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Reports and General Procedural Issues 

 	
  

 	
  

 	
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 reporting AE’s and general procedural issues

 	
  

 	
  

 	
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Affairs and Labeling Changes 

 	
  

 	
  

 	
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 Secure email address for receipt of Regulatory information
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Schedule 5.1(a)

US Consignment Inventory

	
  

 	
  

 	
  

 	
  

 
	
 Ind Std Desc

 	
 CFN

 	
 Material

 	
 Available Inventory

 
	
  

 	
  

 	
  

 	
  

 
	
 8099TU

 	
 8099

 	
 00613994751003

 	
 [*
* *] 

 
	
  

 	
  

 	
  

 	
  

 
	
 8099TU15

 	
 8099TU15

 	
 00613994145758

 	
 [*
* *] 

 
	
  

 	
  

 	
  

 	
  

 
	
 8099TU15

 	
 8099TU15

 	
 00613994760524

 	
 [*
* *] 

 
	
  

 	
  

 	
  

 	
  

 
	
  

 	
  

 	
  

 	
  

 
	
 8929

 	
 8929

 	
 00613994757463

 	
 [*
* *] 

 
	
  

 	
  

 	
  

 	
  

 
	
 8930

 	
 8930001

 	
 00613994529251

 	
 [*
* *] 

 
	
  

 	
  

 	
  

 	
  

 
	
 8930

 	
 8930001

 	
 00885074460376

 	
 [*
* *] 

 
	
  

 	
  

 	
  

 	
  

 

Schedule 5.5(a)

Transfer Prices

	
  

 	
  

 
	
 Prostiva RF Therapy Kit
 (Model 8929)

 	
 [* * *] 

 
	
  

 	
  

 
	
 Prostiva RF Therapy
 Telescope (Model 8099, 8099TU)

 	
 [* * *] 

 
	
  

 	
  

 
	
 Prostiva RF Therapy
 Telescope (Model 8099TU15)

 	
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 Prostiva RF Therapy
 Generator (Model 8930001 and 8930002)

 	
 [* * *] 

 
	
  

 	
  

 
	
 US Configuration:

 	
 [* * *] 

 
	
  

 	
  

 
	
 OUS Configuration:

 	
 [* * *] 

 
	
  

 	
  

 
	
 Remote Footswitch (Model
 60883)

 	
 [* * *]ex101.htm

 

EXHIBIT 10.1

 

 

TOWER INTERNATIONAL

17672 Laurel Park Drive N

Suite 400E

Livonia, MI 48152

 

December 19, 2011

 

Mr. Mark M. Malcolm

President & CEO

Tower International, Inc

Dear Mark:

 

Reference is hereby made to the Employment Agreement, as amended, between Tower Automotive Operations USA I, LLC (the “Company”) and you dated as of August 1, 2007, as extended by letter agreements dated as of June 29, 2009 and June 1, 2010 (as so extended, the “Employment Agreement”). Capitalized terms used in this letter agreement and not specifically defined in this letter agreement shall have the meanings set forth in the Employment Agreement. The principal purpose of this letter agreement is to memorialize the extension of the employment relationship under the Employment Agreement (as contemplated by Section 2 of the Employment Agreement).

 

Subject to your acceptance of the terms set forth in this letter (by signing the enclosed copy of this letter and returning it to the undersigned within the time frame provided):

 

1.            Extension Notice. This letter shall serve as the Company’s written notice to you of its intention to extend the Term of the Employment Agreement and shall be deemed the Extension Notice contemplated under Section 2 of the Employment Agreement.

 

2.            Term. Section 2 of your Employment Agreement is hereby amended to permit the Company to extend your Employment Agreement for periods of either one, two or three years (rather than just one-year or two-year extension periods). To effect this change, the second sentence of Section 2 is hereby amended and restated to read:

 

“Effective upon the expiration of the Initial Term and of each Additional Term (as defined below), if any, this Agreement and the employment relationship hereunder may be extended for an additional period of one (1) or, if you agree, two (2) or up to three (3) years, subject to earlier termination pursuant to Section 5, (each, an “Additional Term”), in each such case commencing upon the expiration of the Initial Term or the then-current Additional Term, as the case may be, but only if, at least sixty (60) calendar days prior to the expiration of the Initial Term or the then-current Additional Term, as the case may be, the Company shall have given written notice to the Employee of its intention
to extend the Term of this Agreement and the time period (one or, if you agree, two or three years) of the extension (the “Extension Notice”).”

 

The second Additional Term of your Employment Agreement, which commenced on August 1, 2010 and was heretofore scheduled to expire on July 31, 2012, shall be extended until December 31, 2014 (the “Extended Second Additional Term”).

 

3.            Base Salary. During the course of the Extended Second Additional Term, and pursuant to Section 4.1 of your Employment Agreement, on an annual basis the Compensation Committee shall consider whether to increase your base salary, and such increases, if any, shall take effect on January 1, 2012, January 1, 2013 and January 1, 2014, respectively.

 

4.            Severance Amount. The modifications made in the calculation of the Severance Amount set forth in your letter agreement dated as of June 1, 2010 remain in full force and effect.

 

5.            Restricted Stock Units. Concurrent with your execution of this letter agreement, you shall be awarded restricted stock units covering shares of the common stock of Tower International, Inc. (“Tower”) having a Fair Market Value (as defined in Tower’s 2010 Equity Incentive Plan), as of the date of such award, of $3,000,000. The terms of such restricted stock units shall be governed by a restricted stock unit agreement executed contemporaneously with your execution of this letter agreement.

 

Except as specifically set forth in this letter, all terms of the Employment Agreement shall remain unmodified and in full force and effect.

 

Please acknowledge your understanding and agreement with the terms set forth in this letter agreement by signing the enclosed copy of this letter agreement and returning it to the undersigned on or before December 31, 2011. If you do not sign and return this letter agreement within the time frame provided, this letter agreement (including, without limitation, the Extension Notice) shall be void and of no force and effect and no such restricted stock units shall be granted.

 

We look forward to your continued service to the Company.

 

TOWER INTERNATIONAL, INC.

By: /s/ Bill Cook

Name: William Cook

Title: Senior Vice President

Agreed and accepted this

20th day of December, 2011

/s/ Mark M. Malcom

Mark M. Malcolm

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00197-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00197-of-00352.parquet"}]]