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8-K - FORM 8-K - SPECTRANETICS CORP | c94204e8vk.htm |
Exhibit 10.1
LICENSE AGREEMENT
This License Agreement (the Agreement) is made by and between Dr. Peter Rentrop, M.D., an
individual having offices at Gramercy Cardiac Diagnostic Services, P.C., 920 Broadway, Suite 600,
New York, New York 10010 (Dr. Rentrop), and The Spectranetics Corporation, a Delaware corporation
with its principal place of business at 9965 Federal Drive, Colorado Springs, Colorado 80921 (each
individually a Party and collectively the Parties).
RECITALS
WHEREAS, Dr. Rentrop is the sole inventor of and owns all right, title, and interest in and to
U.S. Patent Nos. 6,440,125 and 6,673,064 and any applications claiming priority thereto, and any
reissues, reexaminations thereof;
WHEREAS, the Parties are involved in litigation in the U.S. District Court for the Southern
District of New York, Case No. 1:2004cv00101 (PKC), before Hon. Judge P. Kevin Castel (the
Litigation);
WHEREAS, the Litigation was tried to the jury, resulting in a jury verdict on December 8, 2006
of infringement of claims 1, 8, and 15-17 of U.S. Patent Nos. 6,673,064 by the following catheters:
Point 9 Extreme (over-the-wire) Model 110-001,
Point 9 X80 Extreme (over-the-wire) Models 110-002 and 110-152,
Point 9 Vitesse (rapid exchange) Model 110-003,
Point 9 X80 Vitesse (rapid exchange) Model 110-004,
CLiRpath Turbo Peripheral Over-the-Wire (OTW) 0.9 mm X80 Model 310-152, and CLiRpath
Turbo Peripheral Rapid Exchange (RX) 0.9 mm X80 Model 310-154 (collectively Seven
Vitesse and Turbo Catheters; last two catheters, collectively Turbo Catheters); and
Point 9 X80 Extreme (over-the-wire) Models 110-002 and 110-152,
Point 9 Vitesse (rapid exchange) Model 110-003,
Point 9 X80 Vitesse (rapid exchange) Model 110-004,
CLiRpath Turbo Peripheral Over-the-Wire (OTW) 0.9 mm X80 Model 310-152, and CLiRpath
Turbo Peripheral Rapid Exchange (RX) 0.9 mm X80 Model 310-154 (collectively Seven
Vitesse and Turbo Catheters; last two catheters, collectively Turbo Catheters); and
further jury verdict of validity, rejection of trade secret misappropriation and conversion
defenses, and finding Dr. Rentrop to be the sole inventor of U.S. Patent Nos. 6,673,064 and
6,440,125 and damages of $650,000;
WHEREAS, the Court denied Spectranetics motion for judgment as a matter of law of
non-infringement and its defenses of inequitable conduct and implied license and entered final
judgment for Dr. Rentrop in the amount of $500,000 on August 24, 2006;
WHEREAS, the Court of Appeals for the Federal Circuit affirmed the final judgment for Dr.
Rentrop in all respects on December 18, 2008;
WHEREAS, the U.S. Patent and Trademark Office (USPTO), at Spectranetics request, declared
an ex parte reexamination of U.S. Patent Nos. 6,440,125 and 6,673,064
and in September 2009
confirmed that all of the originally issued claims therein were patentable;
WHEREAS, Spectranetics has continued the manufacture, sale, and use of the adjudged infringing
Seven Vitesse and Turbo Catheters to date; and
WHEREAS, the Parties desire to resolve the issue of ongoing royalties for Spectranetics
continued infringement to date and to enter into a license relationship going forward;
NOW, THEREFORE, in consideration of the mutual promises set forth herein and for other good
and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties agree as follows:
1. DEFINITIONS
1.1 Affiliate shall mean any entity controlled by, controlling or under common control of a
Party; control and its derivatives means the possession of the power to direct or cause the
direction of management and operations of such entity and/or the ownership of more than fifty
percent (50%) of (i) the capital, (ii) voting rights, and/or (iii) the right to elect or appoint
directors.
1.2 Spectranetics shall mean The Spectranetics Corporation, a Delaware corporation with its
principal place of business at 9965 Federal Drive, Colorado Springs, Colorado 80921, and any of its
Affiliates.
1.3 Effective Date shall mean the date specified in Section 3.3.
1.4 Rentrop Patent(s) shall mean U.S. Patent Nos. 6,440,125 and 6,673,064, and all
divisionals, continuations, continuations-in-part, reexaminations or reissuances, based upon or
derived from U.S. Patent Nos. 6,440,125 and 6,673,064, including claims issuing from U.S. Patent
App. 11/646,743 and all divisionals, continuations, continuations-in-part, reexaminations or
reissuances thereof, and all other patents presently owned or assigned to Dr. Rentrop relating to
Licensed Catheters. A listing of the Rentrop Patents is attached as Exhibit A.
1.5 Licensed Catheter(s) shall mean the following laser catheters: .9 Vitesse, ELCA
(110-003); .9 Vitesse, ELCA 80/80 (110-004); .9 Extreme, ELCA (110-001); .9 Extreme 80/80, ELCA
(110-002); .9 Extreme 80/80, ELCA (110-152); .9X-80 Extreme, CO, ClirPath (310-152); .9 Vitesse
80Hz, CO, ClirPath (310-154), .9 X-90 Vitesse (110-154); .7 Extreme Turbo (310-155); .7 Extreme OTW
X80 (110-005); and Turbo Elite Catheters (the .9 OTW Turbo Elite (410-152) and .9 RX Turbo Elite
(410-154) catheters) and any Additional Catheter(s) and any combination products which
include any of the above catheter(s) designed, developed, marketed, sold, used or manufactured by
Spectranetics in the United States.
1.6 Additional Catheter(s) shall mean any laser catheter designed, developed, marketed,
sold, used, or manufactured by Spectranetics in the United States,
having a tip diameter of less
than 1mm, and which: (i) Spectranetics claims for regulatory purposes or otherwise to be
substantially equivalent to any of the Seven Vitesse and Turbo Catheters and Turbo Elite Catheters
or for which any of the Seven Vitesse and Turbo Catheters and Turbo Elite Catheters serve as
predicate devices, or (ii) is insubstantially different from or a colorable variation of any of the
Seven Vitesse and Turbo Catheters and Turbo Elite Catheters, or (iii) otherwise infringes one or
more claims of the Rentrop Patents.
1.7 Net Sales shall mean (i) the amount separately billed or invoiced for sales of Licensed
Catheters manufactured or sold in the United States to Spectraneticss third party customers, after
the deduction of Cap Free Up-Charge and regular trade and quantity discounts actually given, and
returns actually made, or (ii) if Licensed Catheters are transferred to a third party without
consideration other than for uses in research or clinical trials, or are not separately billed or
invoiced, the amount equal to the greater of (1) the average invoiced or billed price of the
Licensed Catheters separately billed or invoiced over the preceding 12 months multiplied by the
number of Licensed Catheters so transferred, or (2) the portion of the lump sum fee attributable to
the Licensed Catheters on a pro rata basis as a percentage of any bundled product offering that
includes Licensed Catheters. Licensed Catheters transferred to a third party without consideration
for uses in research or clinical trials, and where that entity and personnel performing such
research and/or clinical trial are not separately compensated by Spectranetics for the treatment or
procedures performed using Licensed Catheters shall not be Net Sales provided Spectranetics
provides Dr. Rentrop with the number of the Licensed Catheters used or transferred in connection
with any clinical trial and the name of the clinical study as part of the Accounting Report under
Article 3.5 of the Agreement. For research or clinical trials involving the transfer of 100 or more
catheters, Spectranetics shall further provide Dr. Rentrop with the number of patients involved in
the study and notification of published results of the study as part of the reporting and auditing
obligations under Articles 3.5 3.7. Spectraneticss manufacture or use of a Licensed Catheter for
internal research and development purposes, which does not involve treatment of patients, is not a
Net Sale under this Agreement. The number of Licensed Catheters used in clinical trials shall not
exceed 15% of the number of Licensed Catheters on which Spectranetics paid Dr. Rentrop royalties
during the preceding calendar year.
1.8 Cap Free Up-Charge shall mean, for Spectranetics customers paying reduced fees for use
of the excimer laser machine only, the difference between list price of the Licensed Catheters and
the higher actual amount charged these customers for the Licensed Catheters.
1.9 Quarterly Minimum Royalty shall mean $135,000 (one hundred thirty five thousand U.S.
dollars).
2. LICENSE GRANT
2.1 Subject to all other provisions of this Agreement, Dr. Rentrop hereby grants to
Spectranetics a world-wide exclusive, nontransferable, personal, sublicenseable
only to those
companies against which Spectranetics enforces the Rentrop Patents pursuant to Section 8 of this
Agreement, revocable, royalty-bearing license under the Rentrop Patents to make, use, offer for
sale, import, sell, or otherwise dispose of Licensed Catheters.
2.2 The license granted under this Agreement shall not be construed to convey to Spectranetics
any additional rights to the Rentrop Patents, including but not limited to title or ownership
rights. Subject to the following restrictions, Dr. Rentrop grants Spectranetics a limited right to
have Licensed Catheters made (have made) by Spectraneticss manufacturers (OEMs) of the Licensed
Catheters, whose number should not exceed three OEMs in any calendar year. Spectranetics shall
contractually restrict and require that Spectraneticss OEMs shall only manufacture Licensed
Catheters exclusively for Spectranetics and shall not manufacture, transfer, or sell them to any
other entity, and that the number of such Licesensed Catheters made by Spectranetics OEM shall not
exceed the number of Licensed Catheters Spectranetics purchases from Spectranetics OEMs.
Spectranetics shall use its best efforts to select only reputable OEMs with no known prior
instances of unauthorized manufacture and sale, and to ensure Spectranetics OEMs actual compliance
with these restrictions. Upon notice from Dr. Rentrop that Spectranetics OEMs are engaged in
unauthorized manufacturing, offerings for sale, importation, use, or sales of the Licensed
Catheters to third parties, Spectranetics shall expeditiously take steps to stop the OEM from the
unauthorized manufacture and sale of the catheters, and if the OEM fails to do so, terminate its
agreement with the noncompliant OEM and expeditiously institute and prosecute, at its own expense,
an action seeking to stop the noncompliant OEM from continuing such unauthorized acts.
2.3 The license granted under this Agreement shall continue in full force and effect from the
Effective Date until January 4, 2020, unless this Agreement is earlier terminated in accordance
with section 10 herein.
2.4 In the event Spectranetics fails to make a quarterly royalty payment in excess of $135,000
in a quarter, this license grant shall convert from an exclusive license to a non-exclusive,
nontransferable, personal, nonsublicenseable, revocable, royalty-bearing license under the Rentrop
Patents to make, use, offer for sale, import, sell, or otherwise dispose of Licensed Catheters with
no reduction or change to the royalty rate and other obligations of Spectranetics under this
Agreement. Any sublicense executed prior to the conversion of the exclusive license to a
non-exclusive license shall remain valid.
2.5 Within ten (10) days of the Effective Date of this Agreement, the parties shall execute
and file with the Court the Consent Judgment in the form attached hereto.
3. PAYMENTS, ROYALTIES, AND ACCOUNTING
3.1 Spectranetics shall pay to Dr. Rentrop a non-refundable and non-recoverable royalty at a
rate of 10% (ten percent) of Net Sales of the Licensed Catheters, the accrual of which begins on
October 1, 2009. All payments to Dr. Rentrop should be wire transferred in U.S. dollars to the
account number at Citibank, N.A. Br.
#584, New York, NY 10010 (ABA Routing Number
) or to another account as may be specified in writing by Dr. Rentrop pursuant to section
11.9 herein.
3.2 Royalties shall accrue when any Licensed Catheter is shipped, invoiced, transferred or
otherwise delivered to a third party, whichever is earlier, regardless of when or whether payment
is received by Spectranetics.
3.3 Based on Spectranetics representation and warranty, on which Dr. Rentrop relies, that Net
Sales of the Licensed Catheters between November 1, 2006 and September 30, 2009 are $21,012,396,
the accrued royalties due Dr. Rentrop for that period are $2,101,239 plus interest at the rate of
4.16% compounded annually. No later than 10 business days after the execution of this Agreement,
Spectranetics shall (i) make a lump sum payment of $2,266,175 to pay all the accrued royalties and
interest for the period between November 1, 2006 and September 30, 2009; and (ii) a lump sum
payment of $38,488 to pay additional post-judgment interest on the judgment amount of $610,361 for
the period between August 24, 2007 and February 20, 2009. The Effective Date of this Agreement is
the date Spectranetics makes the lump sum payment of $2,304,663.
3.4 Thirty days after the end of a quarter, i.e., on January 30, April 30, July 30, and
October 30, Spectranetics shall make a quarterly royalty payment equal to the greater of Quarterly
Minimum Royalty or actual royalties due for the immediately preceding quarter. For the period
starting on October 1, 2009, Spectranetics shall compute the amount of royalties due to Dr. Rentrop
on a quarterly basis, and shall furnish Dr. Rentrop with an Accounting Report in the form specified
in section 3.5 no later than thirty (30) days after the end of each calendar quarter.
3.5 The Accounting Report shall include a summary of sales of Licensed Catheters sufficient to
identify the quantity of Licensed Catheters made and sold during the reporting period, the
corresponding Net Sales and applicable deductions, and the total royalty due and method of
calculation thereof, and the number of Licensed Catheters transferred to Third Parties without
consideration.
3.6 Spectranetics shall keep clear, complete and accurate records with respect to Licensed
Catheters manufactured, sold, used, imported, exported or otherwise disposed of for a period of at
least five (5) years following such manufacture, sale, use, import, export or other disposal. Dr.
Rentrop may, at any time upon at least 14 days written notice and during normal business hours,
have independent, third-party auditors inspect and copy Spectranetics books and records, including
those concerning sales, shipment, manufacturing, and patent marking records, relating to any
Accounting Report provided by Spectranetics, and such other records and accounts as may, under
recognized accounting practices, contain information bearing upon the amount of royalties due and
payable pursuant to this Agreement. The auditors must be approved by Spectranetics, although
approval will not be unreasonably withheld, and may be accompanied by Dr.
Rentrops attorneys during the audit. The audit may cover a period of not more than five (5) years
before the first day of the calendar quarter in which the audit is requested. In the event that
such audit shows that Spectranetics has cumulatively underpaid royalties by five percent (5%) or
more, Spectranetics shall pay, no later than ten (10) days after
written itemized demand by Dr.
Rentrop, the direct out-of-pocket costs and expenses of such audit (including the reasonable fees
charged by Dr. Rentrops auditors and attorneys involved in the audit), in addition to the amount
of 110% of the underpayment and interest thereon. In the event that such audit shows that
Spectranetics has cumulatively underpaid royalties by less than five percent (5%), Spectranetics
shall pay, no later than ten (10) days after written itemized demand by Dr. Rentrop, the amount of
the underpayment and interest thereon. Notwithstanding the terms of this section of the Agreement,
Dr. Rentrop shall not be permitted to request an audit more than once in a twelve-month period of
time. Any overage of payment of royalties by Spectranetics for a given quarter may be deducted
from a quarterly royalty payment for any six (6) succeeding quarters following discovery of the
overpayment but only from the portion of such quarterly royalty payment that exceeds the Quarterly
Minimum Royalty. Except for overage recovery specified in the preceeding sentence, Spectranetics,
as partial consideration for the license granted herein by Dr. Rentrop to Spectranetics, hereby
waives any right it may have to a refund of any royalties or other amounts actually paid to Dr.
Rentrop or a portion thereof.
3.7 Spectranetics agrees to cooperate reasonably with Dr. Rentrops auditors and attorneys in
connection with any such audit. During the audit, Spectranetics shall provide Dr. Rentrops
auditors and attorneys with all information reasonably requested, including without limitation,
information relating to sales, inventory, transfer records, invoices, purchase orders, sales
orders, shipping documentation, patent marking records, cost information, customer lists,
pricing/invoicing/revenue recognition and allocation policies, and agreements with third parties or
affiliates of Spectranetics.
3.8 Spectranetics shall pay to Dr. Rentrop interest for any payment that is late at an
interest rate of 4.16% per annum compounded quarterly.
3.9 Transfer Pricing. In the event Spectranetics transfers a Licensed Catheter to an
affiliate or subsidiary for further sale to a third party customer, the price used as the basis for
calculating the royalty owed by Spectranetics shall be price of the Licensed Catheter sold by the
affiliate or subsidiary to the third-party customer.
3.10 In addition to the royalties due and payable to Dr. Rentrop in accordance with section 3,
Spectranetics shall pay royalties to Dr. Rentrop on all Licensed Catheters manufactured prior to,
but remaining in Spectranetics inventory at the date of expiration or termination of this
Agreement. The royalties due on the Licensed Catheters in inventory at the date of expiration or
termination shall be computed by multiplying the 10% royalty rate by the average selling price of
the Licensed Catheters over the immediately preceding calendar year. No later than thirty (30)
days after the date of termination or expiration of this Agreement, Spectranetics shall pay Dr.
Rentrop any and all amounts that are due pursuant to this Agreement as of the date of such
termination or expiration, together with an Accounting Report for such payment, duly certified by
an
officer of Spectranetics, specifying (i) the total quantities of Licensed Catheters, identifying
(by catalogue number or the like) the types of such Licensed Catheters, in inventory on the date of
expiration or termination of this Agreement; (ii) the total number of orders pending for the
Licensed Catheters on the date of expiration or termination of
this Agreement; and (iii) the total
royalties due and payable for such Licensed Catheters, except that such Accounting Report shall
cover the period from the end of the last calendar quarter prior to termination or expiration to
the date of termination or expiration. Nothing in the foregoing shall be deemed to satisfy any of
Spectranetics other obligations under this Agreement upon termination or expiration.
4. ADDITIONAL PRODUCTS
4.1 Spectranetics represents and warrants that all of its laser catheters having a tip
diameter of less than 1mm are set forth on Exhibit B by trade name and model number. Spectranetics
further represents and warrants that there are no laser catheters having a tip diameter of less
than 1mm for which Spectranetics has applied for regulatory clearance as of the Effective Date
which are not set forth on Exhibit B.
4.2 Spectranetics shall provide Dr. Rentrop with written notice of each laser catheter having
a tip diameter less than 1 mm it intends to introduce to the market, by itself or as part of a kit
or a combination of products and/or services no later than 30 days after Spectranetics first
applies for regulatory approval for sales within or outside the United States with respect to such
laser catheter. In such notice Spectranetics shall state whether such laser catheter should be
deemed an Additional Catheter and should be subject to payment of royalties under this Agreement.
If Spectranetics deems such catheter not to be an Additional Catheter, it should include in such
notice a detailed claim-by-claim explanation of why it believes such catheter does not embody each
claim element of the Rentrop Patents literally and under the doctrine of equivalents. Dr. Rentrop
shall have the right to make a reasonable request for information, including but not limited to
product brochures, final engineering drawings, physical sample, testing data, and regulatory
submissions. No later than 14 days after Dr. Rentrop makes a request for information, Spectranetics
shall provide all information reasonably requested by Dr. Rentrop in sufficient detail to enable
Dr. Rentrop to determine the structure, intended use, and projected sales of such catheter. Any
information provided to Dr. Rentrop shall be provided pursuant to the protective order entered in
the Litigation.
4.3 Upon receipt of the information provided by Spectranetics pursuant to Section 4.2 Dr.
Rentrop shall provide notice within 45 days to Spectranetics if Dr. Rentrop believes a catheter
identified pursuant to section 4.2 is an additional Licensed Catheter and should be subject to the
payment of royalties under this Agreement. (Dr. Rentrop shall have the option to reasonably
request additional documentation or explanation regarding structure, function, or use of such
catheter from Spectranetics if Dr. Rentrop deems information already provided to be insufficient to
complete his analysis.)
4.4 The Parties shall have sixty (60) days to resolve whether such catheter identified
pursuant to section 4.2 or 4.8 is an additional Licensed Catheter under this Agreement and any
other relevant issues.
4.5 If the Parties reach agreement that such catheter to be introduced to the market should
become an additional Licensed Catheter under this Agreement, such
catheter shall be added to this
Agreement by a signed written amendment after which such catheter shall become a Licensed Catheter
under this Agreement. Spectranetics shall pay Dr. Rentrop royalties for the Additional Catheter
pursuant to Article 3 of this Agreement which start accruing from the date of first sale or
transfer of such Additional Catheter.
4.6 If the Parties are unable to reach agreement regarding whether the Additional Product
infringes a claim of the Rentrop Patents, the sole remedy for either Party shall be to file a claim
for arbitration with the American Arbitration Association to be heard and resolved in New York City
by Judge Robert Faulkner as arbitrator, if available, and if not available, a mutually agreed
replacement (the Arbitration), and to make a motion in the Arbitration in a summary manner to
determine whether any of Spectranetics catheters, to be introduced to the market by Spectranetics
subsequent to the Effective Date, having a tip diameter less than 1mm, are insubstantially
different from or a mere colorable variation of the adjudged infringing Seven Vitesse and Turbo
Catheters and stipulated infringing Turbo Elite Catheters and are to be included as an Additional
Catheter.
4.7 An action brought pursuant to section 4.6 above shall not provide a basis to terminate
this Agreement with respect to the Licensed Catheters or to stop or delay any payments under this
Agreement.
4.8 Dr. Rentrop may at any time provide Spectranetics with written notice that he considers a
particular Spectranetics catheter an Additional Catheter under this License Agreement. Together
with or after such notice, Dr. Rentrop may demand and Spectranetics shall provide information and
documents specified in section 4.2 regarding such catheter.
5. PATENT MARKING
5.1 Spectranetics shall mark the packaging of all the Licensed Catheters manufactured after
the Effective Date with the notation Licensed under United States Patent No(s). . Other
patent(s) pending with the blanks appropriately filled in for each Licensed Catheter.
Notwithstanding the above, Spectranetics is under no obligation to mark the packaging of any
Licensed Catheter already manufactured, and shall have up to six months after the Effective Date of
this Agreement, or until the appropriate regulatory agencies allow, which ever is later, to begin
marking the packaging of Licensed Catheters. Spectranetics shall diligently use its best efforts
to obtain such regulatory approval without delay and shall provide Dr. Rentrop with copies of all
correspondence with the appropriate regulatory agency regarding this issue.
6. NO CHALLENGES TO THE RENTROP PATENTS
6.1 Spectranetics agrees and acknowledges that the Rentrop Patents are valid and enforceable.
Spectranetics further agrees and acknowledges that but for this Agreement, its Turbo Elite
Catheters would infringe one or more of the claims of the Rentrop Patents.
6.2 Spectranetics or its respective officers, directors, shareholders, employees, agents,
customers, distributors, officials, subsidiaries, affiliates, predecessors, successors, or assigns
shall not challenge the validity, enforceability, or scope of the Rentrop Patents in any action,
proceeding, arbitration, reexamination, reissue or the like after the Effective Date nor shall it
participate in, assist, aid, or abet any third party in doing so. This waiver applies to any
product made, used, or sold by Spectranetics.
6.3 Dr. Rentrop, on behalf of himself and his agents, servants, employees, officers,
directors, parents, subsidiaries and affiliates, franchises, successors and assigns (collectively
the Affiliates), covenants and agrees that neither he nor any of his Affiliates will bring a
lawsuit, claim, or cause of action against Spectranetics or its respective officers, directors,
shareholders, employees, agents, customers, distributors, officials, predecessors, successors, or
assigns, for infringement of the Rentrop Patents with respect to the Licensed Catheters or any
Additional Catheters so long as this Agreement remains in full force and effect and Spectranetics
has fully complied with its royalty payment and reporting obligations.
6.4 In the event Spectranetics, its present and future officers, directors, employees,
agents, subsidiaries, successor corporations or partnerships, affiliates, assigns and any and all
persons and entities in active concert or participation with any of them initiates any proceeding
or otherwise asserts any claim challenging the validity or enforceability of any Rentrop Patent in
any court, administrative agency or other forum or participates in, assists, aids, or abets any
third party in doing so (Challenge), all royalty rates, Quarterly Minimum Royalty, and other
payments under this Agreement shall be automatically doubled on and after the date of such
Challenge for the remaining term of this Agreement.
7. REPRESENTATIONS AND WARRANTIES
7.1 Dr. Rentrop warrants that he owns all right, title, and interest in and to the Rentrop
Patents and has the right to grant the license set forth in this Agreement. Dr. Rentrop disclaims
all other warranties, representations or guarantees of any kind as to the Rentrop Patents and
Licensed Catheters, including but not limited to warranties of merchantability, fitness, adequacy
or suitability for a particular purpose, use or result.
7.2 In no event shall Dr. Rentrop, have any liability to Spectranetics or to any third party
arising out of the use, operation or application of the Rentrop Patents, Licensed Catheters, or
anything discovered, developed, manufactured, used, sold, offered for sale, imported, exported,
distributed, rented, leased or otherwise disposed of under the license granted hereunder, by
Spectranetics or any third party for any reason, including
but not limited to, the unmerchantability, inadequacy or unsuitability of the Rentrop Patents,
Licensed Catheters and/or anything discovered, developed, manufactured, used, sold, offered for
sale, imported, exported, distributed, rented, leased or otherwise disposed of under the license
granted hereunder for any particular purpose or to produce any particular result, or for any latent
defects therein.
7.3 In no event shall Dr. Rentrop, have any liability to Spectranetics or any third party for
any consequential, incidental, special or indirect damages (including, but not limited to, from any
destruction to property or from any loss of use, revenue, profit, time or good will) based on
activity arising out of or related to this Agreement, whether pursuant to a claim of breach of
contract or any other claim of any type.
7.4 In no event shall Dr. Rentrops liability to Spectranetics exceed the payments made to Dr.
Rentrop by Spectranetics under this Agreement.
7.5 The Parties hereto acknowledge that the limitations and exclusions of liability and
disclaimers of warranty set forth in this Agreement form an essential basis of the bargain between
the Parties.
7.6 Nothing contained in this Agreement shall be construed as:
(a) a warranty or representation by Dr. Rentrop as to the validity or scope of any of the
Rentrop Patents;
(b) a warranty or representation that any manufacture, sale, use, lease, importation,
exportation or other disposal of any Licensed Catheter will be free from infringement of any patent
or other industrial or intellectual property rights of any third party;
(c) conferring by implication, estoppel or otherwise upon Spectranetics any license or other
right under any patent or other industrial or intellectual property rights other than those patent
rights expressly granted in this Agreement;
(d) conferring on Spectranetics any license or other right under the patent rights licensed
under this Agreement to manufacture, offer for sale, sell, use, import, export or otherwise dispose
of a product or apparatus other than a Licensed Catheter;
(e) conferring on Dr. Rentrop an obligation to file any patent application, or to secure any
patent;
(f) conferring on Dr. Rentrop an obligation to make any determination as to the applicability
of any patents to any product of Spectranetics;
(g) imposing on Dr. Rentrop an obligation to institute any suit or action for infringement of
any of the Rentrop Patents licensed under this Agreement or to defend any suit or action brought by
a third party which challenges or concerns the validity of the Rentrop Patents;
(h) conferring on Dr. Rentrop an obligation to furnish any manufacturing or technical
information or assistance; nor
(i) conferring on Spectranetics any right to use, in advertising, publicity or otherwise, any
name, likeness, trade name, service mark, or trademark of Dr. Rentrop.
8. INDEMNITIES AND INFRINGEMENT ACTIONS
8.1 Spectranetics may prosecute in good faith any and all infringements of the Rentrop
Patents. Prior to Spectranetics filing, initiating, or raising any claim concerning the Rentrop
Patents, Spectranetics shall provide Dr. Rentrop with information on which such claim is based,
including but not limited to infringement, validity, and damages analyses, and litigation budget
and strategy, and seek Dr. Rentrops permission to proceed with such litigation to be prosecuted by
its proposed counsel, and such permission shall not be unreasonably withheld. Spectranetics shall
reimburse Dr. Rentrop for reasonable attorneys fees and costs incurred by his counsel in
evaluating Spectranetics request, not to exceed $15,000, no later than 30 days after a written
demand therefor. Dr. Rentrop agrees to share the analysis and/or work product generated as the
result of this analysis. Dr. Rentrop shall respond to Spectraneticss request within 30 days of
the request and receipt of complete information specified above, except in the event Spectranetics
indicates to Dr. Rentrop it may seek a preliminary injunction, in which case Dr. Rentrop shall
respond to Spectraneticss request within 20 days of the request and receipt of complete
information specified above. The Parties represent and warrant that each is presently unaware of
any such infringement of the Rentrop Patents and has no present reason to suspect same.
8.2 Spectranetics shall prosecute in good faith any claims approved by Dr. Rentrop in
accordance with section 8.1 at its own cost and expense. Spectranetics shall provide, at its own
expense, Dr. Rentrop and his counsel with copies of all pleadings, correspondence, memoranda,
opinions, transcripts, reports, and other documents concerning the prosecution of such claim,
subject to the terms of any protective order entered in the litigation. Spectranetics specifically
shall attempt to include Dr. Rentrop as a recipient of confidential information in any such
protective order. Spectranetics shall consult with Dr. Rentrop regarding significant litigation
related decisions, such as claim construction, infringement, or validity positions. Spectranetics
may enter into settlements, stipulated judgments or other arrangements regarding such infringement
without the written consent of Dr. Rentrop but may not do so with respect to validity or
enforceability of the Rentrop Patents to the extent the settlement, stipulated judgment, or other
arrangement results in a finding or agreement of invalidity or non-enforceability of one or more of
the claims of the Rentrop Patents without the consent of Dr. Rentrop, which shall not be
unreasonably withheld. Dr. Rentrop shall permit any action for infringement under the Rentrop
Patents to be brought in his name if required by law in which case he will be represented in such
action by the counsel of Spectranetics choosing at Spectraneticss expense, and/or, at Dr.
Rentrops option, of Dr. Rentrops choosing at his own expense, in which case Spectranetics agrees
to reimburse Dr. Rentrop up to $35,000 no later than 30 days after a written demand therefor. Upon
Spectraneticss request, Dr.
Rentrop agrees to provide reasonable assistance of a technical nature which Spectranetics may
require in any litigation arising in accordance with the provisions of this section, for which
Spectranetics agrees to pay to Dr. Rentrop a reasonable hourly rate of
compensation of not less
than $500 an hour. In the event Spectranetics refuses to prosecute a claim against a third-party
for infringement of the Rentrop Patents brought to Spectraneticss attention by Dr. Rentrop, Dr.
Rentrop shall have the right to prosecute any action related to the Rentrop Patents without
consent, involvement, or sharing any recovery with Spectranetics.
8.3 Any damages or other recovery, including a settlement or a sublicense taken by a third
party, which results from an infringement action undertaken by Spectranetics under Section 8.1
shall first be used to reimburse the parties for their costs and expenses incurred in good faith in
such action, and shall thereafter be allocated between the parties as follows: (i) fifty percent
(50%) to Dr. Rentrop and (ii) fifty percent (50%) to Spectranetics.
8.4 Spectranetics shall indemnify, defend, and hold harmless Dr. Rentrop from and against any
and all third-party actions, suits, claims, demands, prosecutions, liabilities, costs, expenses,
damages, deficiencies, losses or obligations (including reasonable attorneys fees) based on,
arising out of, or relating to this Agreement, including, without limitation, (i) the discovery,
development, manufacture, packaging, use, sale, offering for sale, importation, exportation,
distribution, rental or lease of Licensed Catheters, even if altered for use for a purpose not
intended, (ii) the use of the Rentrop Patents by Spectranetics or its customers, (iii) any
representation made or warranty given by Spectranetics with respect to the Rentrop Patents or the
Licensed Catheters, and (iv) any infringement claims relating to the Licensed Catheters.
Spectranetics shall reimburse Dr. Rentrop for the actual reasonable fees, costs, and expenses
(including reasonable attorneys fees) that he may incur in enforcing this provision no later than
30 days after written itemized demand by Dr. Rentrop for such reimbursement.
9. MATERIAL BREACH AND CURE
9.1 In addition to the applicable legal standards, Spectranetics shall be deemed to be in
material breach of this Agreement if it fails, at any time, to make full and timely payments of
royalties and interest, timely submit any information or reports required by this Agreement,
reasonably cooperate with Dr. Rentrop in auditing Spectranetics books and records, initiates or
prosecutes any claim concerning the Rentrop Patents without Dr. Rentrops approval, commits any
breach of any covenant contained in this Agreement, makes a materially inaccurate statement or
report, commences or participates in any challenge to the Rentrop Patents, or failes to
expeditiously take steps to stop the OEM from the unauthorized manufacture and sale of the
catheters, and if the OEM fails to do so, fails to terminate its agreement with the noncompliant
OEM.
9.2 Either Party shall have the right to cure its material breach provided the cure is
effected within 30 days after written notice thereof by the other Party.
10. TERMINATION
10.1. If a material breach by Spectranetics remains uncured for 30 days after written notice,
Dr. Rentrop, in his sole discretion, may, at his option, terminate this Agreement and the license
granted to Spectranetics herein or any part thereof.
10.2 In the event Spectranetics commences any action against Dr. Rentrop relating to the
Rentrop Patents during the term of this Agreement, Dr. Rentrop may, in his sole discretion,
forthwith, terminate this Agreement and the license granted to Spectranetics herein or any part
thereof.
10.3 If Spectranetics should become insolvent, a subject of a voluntary bankruptcy, a subject
of an involuntary petition in bankruptcy not resolved or bonded over within 90 days, be dissolved,
seek court or governmental protection from creditors, make any assignment for creditors, or should
a receiver or trustee be appointed for Spectranetics, Spectranetics shall give Dr. Rentrop notice
of any of the events specified in this section no later than 10 days after the occurrence of such
event. Upon the occurrence of any such event, Dr. Rentrop may terminate this Agreement by written
notice of Termination to Spectranetics terminating this Agreement and the license granted to
Spectranetics herein or any part thereof.
10.4 This Agreement shall terminate if the 064 patent and the 125 patent should expire, be
declared invalid, unenforceable, or lapse, except that if the 064 and 125 patent are finally
declared invalid or unenforceable due to an action brought by Spectranetics pursuant to Section 8
of this Agreement, the royalty rate under Section 3.1 of this Agreement shall become 5%, payable
for one-half the otherwise remaining patent terms of the 064 and 125 patents, at which time
Spectranetics receives a royalty-free license to the Rentrop Patents.
10.5 Unless previously terminated in accordance with other provisions of this Agreement, this
Agreement shall continue until January 4, 2020 and shall thereupon terminate.
11. MISCELLANEOUS PROVISIONS
11.1 Waiver and Election of Remedies. The failure of any party to insist upon strict
adherence to any term of this Agreement on any occasion shall not be considered a waiver or deprive
that party thereafter of the right to insist upon strict adherence to that term or any other term
of this Agreement. All waivers must be in writing and signed by an authorized representative of
the party against which such waiver is being asserted. The pursuit by either party of any remedy
to which it is entitled at any time or continuation of the Agreement despite a breach by the other
party shall not be deemed an election of remedies or waiver of the right to pursue any other
remedies to which it may be entitled.
11.2 Costs and Expenses. Each Party shall pay its own costs and expenses, including court
costs and attorneys fees associated with the mediation, settlement and the creation of this
Agreement. The parties agree that the Arbitrator may, in its sole
discretion, and upon a finding that one party failed to act in good faith, award attorneys
fees, or a portion thereof, to the prevailing party in any dispute arising out of this Agreement.
11.3 Governing Law. This Agreement shall be construed under the laws of the State of New York
notwithstanding any conflict of law principles. The Parties consent and stipulate that any dispute
regarding this Agreement shall be exclusively brought and resolved in arbitration before Judge
Robert Faulkner, if available, and if not available, a mutually agreed replacement, conducted in
New York City in accordance with the rules and procedure of the AAA., and the Parties consent and
stipulate to the exclusive jurisdiction thereof. Any litigation arising out of or in connection
with such arbitration shall be brought exclusively in the U.S. District Court for the Southern
District of New York. The Parties shall however attempt in good faith to resolve any dispute prior
to resorting to arbitration or court.
11.4 Entire Agreement. This Agreement contains the entire agreement between the Parties
relating to the subject matter hereof, and may only be amended or supplemented in a writing signed
by both Parties.
11.5 Successors and Assigns. This Agreement shall be binding upon and shall inure to the
benefit of the Parties, their agents, servants, employees, officers, directors, successors and
assigns. This Agreement may not be assigned by Spectranetics, other than in connection with the
sale of all or substantially all of the assets of Spectranetics, without the written consent of Dr.
Rentrop, which consent shall not be unreasonably withheld. Dr. Rentrop may assign his rights to
receive royalty and other payments under this Agreement upon notice to and without the consent of
Spectranetics.
11.6 Severability. If any provision of this Agreement is determined to be invalid or
unenforceable, the remainder of the Agreement shall remain unaffected.
11.7 Counterparts. This Agreement may be executed in one or more counterparts, each of which
shall be deemed to be an original, and all counterparts together shall constitute the Agreement.
11.8 Secrecy of Patent Applications. Spectranetics agrees not to have access and not to
demand access to any unpublished patent application of Dr. Rentrop which is unrelated to excimer
laser catheters.
11.9 Notices. All notices, demands, and communications provided for herein or made hereunder
shall be in writing and shall be deemed to have been given (i) upon receipt, when personally
delivered; (ii) upon receipt when sent by overnight courier; or (iii) on the first business day
after transmission by electronic means, if a hard copy is sent simultaneously by certified mail,
overnight courier, or personal delivery. All notices shall be addressed to the party to receive
such notice as follows:
If to Dr. Rentrop:
|
Dr. Peter Rentrop | |
c/o Gramercy Cardiac Diagnostic Services, P.C. | ||
920 Broadway, Suite 600 | ||
New York, New York 10010 | ||
With a copy to:
|
Marvin S. Gittes | |
Mintz, Levin, Cohn, Ferris, | ||
Glovsky and Popeo, P.C. | ||
Chrysler Center | ||
666 Third Avenue | ||
New York, New York 10017 | ||
msgittes@mintz.com | ||
If to Spectranetics:
|
Roger Wertheimer | |
Vice President and General Counsel | ||
9965 Federal Drive | ||
Colorado Springs, Colorado 80921 | ||
roger.wertheimer@spectranetics.com | ||
With a copy to:
|
Kenneth S. Chang | |
Townsend and Townsend and Crew LLP | ||
1400 Wewatta Street, Suite 600, | ||
Denver, CO 80202 | ||
kschang@townsend.com |
11.10 Confidentiality. The Parties shall hold this Agreement in confidence and shall not
disclose the terms or conditions of this Agreement without the prior written permission of the
other Party, which consent shall not be unreasonably withheld. Notwithstanding the foregoing,
either Party may disclose this Agreement and its terms and conditions: (i) to the extent necessary
to enforce its rights under this Agreement; (ii) pursuant to a valid court order or subpoena; (iii)
to a Partys accountants and attorneys; (iv) to prospective licensees or business partners or
investors, provided however that any such disclosure imposes on the receiving party confidentiality
oblications at least as restrictive as provided herein. Nothwithstanding the foregoing,
Spectraneticss may file with the SEC or other governmental agency, or otherwise as required by
law, upon advice of counsel, issue any press release or other filing regarding this Agreement as it
deems appropriate. Additionally, each Party shall have the right to publicize the existence of this
Agreement and the license granted herein so long as such public notice does not disclose the terms
or conditions of the Agreement.
IN WITNESS WHEREOF, the Parties, through their authorized officers, have caused this Agreement
to be executed as of the Effective Date.
DR. K. PETER RENTROP | THE SPECTRANETICS CORPORATION | |||||||||||||
By: | /s/ K. Peter Rentrop | By: | /s/ Guy A. Childs | |||||||||||
Name: | Name: | Guy A. Childs | ||||||||||||
Title: | Title: | Chief Financial Officer | ||||||||||||
Exhibit A
Listing of the Rentrop Patents:
1. U.S. Patent Nos. 6,440,125;
2. U.S. Patent Nos. 6,673,064; and
3. U.S. Patent Application No. 11/646,743.
EXHIBIT B
MODEL | ||
NUMBER | TRADE NAME | |
110-003
|
.9 Vitesse, ELCA | |
110-004
|
.9 Vitesse 80/80, ELCA | |
110-001
|
.9 Extreme, ELCA | |
110-002
|
.9 Extreme 80/80, ELCA | |
110-152
|
.9 Extreme 80/80, ELCA | |
310-152
|
.9 X-80 Extreme, CO, ClirPath | |
310-154
|
.9 Vitesse 80 Hz, CO, ClirPath | |
410-152
|
.9 OTW Turbo Elite | |
410-154
|
.9 RX Turbo Elite | |
110-005
|
Extreme .7 OTW X80 | |
110-154
|
.9 X-80 Vitesse | |
310-155
|
.7 Extreme Turbo |
FORM OF CONSENT JUDGMENT
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
SOUTHERN DISTRICT OF NEW YORK
X | ||||
: | ||||
DR. PETER RENTROP, |
||||
: | ||||
Plaintiff-Counterdefendant,
|
: | 04 Civ. 0101 (PKC) | ||
V. |
||||
: | ||||
THE SPECTRANETICS CORPORATION, |
||||
: | ||||
Defendant-Counterplaintiff. |
||||
: | ||||
X |
CONSENT JUDGMENT
This action having been tried to the jury, resulting in a jury verdict on December 8, 2006
that claims 1, 8, and 15-17 of U.S. Patent No. 6,673,064 were infringed by the following
catheters:
Point 9 Extreme (over-the-wire) Model 110-001,
Point 9 X80 Extreme (over-the-wire) Models 110-002 and 110-152,
Point 9 X80 Extreme (over-the-wire) Models 110-002 and 110-152,
Point 9 Vitesse (rapid exchange) Model 110-003,
Point 9 X80 Vitesse (rapid exchange) Model 110-004,
Point 9 X80 Vitesse (rapid exchange) Model 110-004,
CLiRpath Turbo Peripheral Over-the-Wire (OTW) 0.9 mm X80 Model 310-152, and
CLiRpath Turbo Peripheral Rapid Exchange (RX) 0.9 mm X80 Model 310-154
CLiRpath Turbo Peripheral Rapid Exchange (RX) 0.9 mm X80 Model 310-154
(collectively Seven Vitesse and Turbo Catheters); and
further jury verdict of validity, rejection of trade secret misappropriation and conversion
defenses, and finding Dr. Peter Rentrop (Dr. Rentrop) to be the sole inventor of U.S. Patent
Nos. 6,673,064 and 6,440,125 and awarding damages of $650,000;
The Court having rejected the motion for judgment as a matter of law of non-infringement
filed by The Spectranetics Corporation (Spectranetics) and its defenses of inequitable conduct
and implied license and having entered final judgment for Dr. Rentrop in the amount of $500,000;
The Court of Appeals for the Federal Circuit having affirmed the final judgment for Dr.
Rentrop on December 18, 2008;
The United States Patent and Trademark Office having, at the request of Spectranetics,
conducted a reexamination and having confirmed patentability of all the of the original claims of
U.S. Patent Nos. 6,673,064 and 6,440,125;
Spectranetics having represented and warranted to Dr. Rentrop, and Dr. Rentrop having
relied thereon, that all of Spectranetics continued sales were completely and accurately reported
to Dr. Rentrop;
The parties wishing to settle the existing controversy over payment of royalties for
continuing sales and license future sales and amicably resolve this issue on consent;
The Court having jurisdiction over the parties and the action;
The Court having considered the representations of the parties;
IT IS HEREBY ORDERED, ADJUDGED AND DECREED that
1. The parties resolved the outstanding issue of ongoing royalties for Spectranetics
continued manufacture, sale, use, offer for sale, or importation of Seven Vitesse and Turbo
Catheters and other catheters on the terms and conditions set forth in a License Agreement executed
on December 30, 2009 (the License Agreement) between Spectranetics and Dr. Rentrop,
which licenses Spectranetics to U.S. Patent Nos. 6,673,064 and 6,440,125. The parties shall
promptly execute any additional documents, if necessary, in order to effectuate the License
Agreement.
2. Spectranetics consents to the entry of judgment that it shall pay Dr. Rentrop
royalties on the terms and conditions set forth in the License Agreement.
3. Contingent upon Spectranetics timely and accurate payments of royalties as they become due
pursuant to the License Agreement for 6 months from the date of this Consent Judgment, this action
shall be dismissed with prejudice.
4. Spectranetics agrees and acknowledges that U.S. Patent Nos. 6,673,064 and 6,440,125 are
valid and enforceable, and that Dr. Rentrop is the sole owner and inventor thereof. Spectranetics
further agrees and acknowledges that but for the License Agreement, its .9mm OTW Turbo Elite, Model
410-152; .9mm RX Turbo Elite, Model 410-154; Extreme .7 OTW X80, Model 110-005; .7 Extreme Turbo,
Model 310-155; .9 X-80 Vitesse, Model 110-154 catheters would infringe one or more of the claims of
U.S. Patent No. 6,673,064.
5. Spectranetics together with its respective officers, directors, shareholders, employees,
agents, customers, distributors, officials, subsidiaries, affiliates, predecessors, successors, or
assigns consents to refrain from challenging the validity, enforceability, inventorship, ownership
or scope of U.S. Patent Nos. 6,673,064 and 6,440,125 and any patent application and/or patent
claiming priority to U.S. Patent Nos. 6,673,064 and/or 6,440,125 in any action, proceeding,
arbitration, reexamination, reissue or the like nor shall it participate in, assist, aid, or abet
any third party in doing so. This waiver applies to any product made, used, or sold by
Spectranetics.
6. The parties shall bear their own respective attorneys fees, costs, expert witness fees,
expert consultant fees, mediation fees, investigation costs or fees arising in connection with the
above-captioned litigation, mediation, settlement, and the creation of the License Agreement.
7. This Consent Judgment shall have the full force and effect of a final order and
judgment under the Federal Rules of Civil Procedure.
8. The Court shall retain continuous jurisdiction to enforce this Consent Judgment
and the License Agreement.
9. Spectranetics waives all right to appeal from this consent judgment.
SO ORDERED:
|
Dated: | |||
United States District Judge |
Agreed as to form: | ||||||||||
MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, P.C. | TOWNSEND TOWNSEND & CREW LLP | |||||||||
By:
|
By: | |||||||||
Timur E. Slonim (TS 0915) | 1400 Wewatta Street, Suite 600, | |||||||||
666 Third Avenue | Denver, CO 80202 | |||||||||
New York, New York 10017 | Tel: (303) 607-3209 | |||||||||
Tel: (212) 935-3000 | Fax: (303) 571-4321 | |||||||||
Fax: (212) 983-3115 | ||||||||||
Attorneys for Defendant Spectranetics Corp. | ||||||||||
Attorneys for
Plaintiff-Counterdefendant, Dr. Peter Rentrop |