Exhibit 10.1(l)
PATENT LICENSE AGREEMENT
This Patent License Agreement, effective the date last signed by the
parties (April 17, 1996) hereinafter referred to as the "Agreement," is by and
between:
Washington University, located at Xxx Xxxxxxxxx Xxxxx, Xx. Xxxxx,
Xxxxxxx 00000, an educational institution and corporation of the State of
Missouri, hereinafter referred to as "WU".
and
Athena Diagnostics, Inc., located at Four Biotech Park, 000 Xxxxxxxxxx
Xxxxxx, Xxxxxxxxx, XX 00000, a corporation of the Commonwealth of Massachusetts,
hereinafter referred to as "ATHENA."
WU and ATHENA agree as follows:
1. BACKGROUND
1.01 In the course of conducting biomedical and behavioral research, WU
investigators made inventions that may have commercial applicability.
1.02 By assignment of rights from a WU employee, WU owns intellectual
property rights claimed in any United States patent applications and patents
corresponding to the assigned inventions. WU also owns any tangible embodiments
of these inventions actually reduced to practice by WU.
1.03 WU desires to transfer these inventions to the private sector
through commercialization licenses to facilitate the commercial development of
products and processes for public use and benefit.
1.04 ATHENA desires to acquire commercialization rights to this
invention in order to develop processes, methods, or marketable products for
public use and benefit.
2. DEFINITIONS
2.01 "Licensed Patent Rights" means:
(a) The U.S. patent and patent applications listed in Appendix A, and
all divisions and continuations of these applications, all patents issuing from
such applications, divisions, and continuations, and any reissues,
reexaminations, and extensions of all such patents;
* Material omitted and filed separately with the Securities and Exchange
Commission pursuant to request for confidential treatment under Rule 406.
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(b) to the extent that the following contain one or more claims
directed to the invention or inventions claimed in (a) above: (i)
continuations-in-part of (a) above; (ii) all divisions and continuations of
these continuations-in-part; (iii) all patents issuing from such
continuations-in-part, divisions, and continuations; and (iv) any reissues,
reexaminations, and extensions of all such patents;
(c) Japanese counterpart foreign applications and patents to (a) and
(b) above.
Licensed Patent Rights shall not include (b) br (c) above to the extent
that they contain one or more claims directed to new matter which is not the
subject matter of a claim in (a) above.
2.02 "Licensed Product(s)" means tangible materials which, in the
course of manufacture, use, or sale, would, in the absence of this Agreement,
(a) infringe one or more claims of the Licensed Patent Rights that have not been
held invalid or unenforceable by an unappealed or unappealable judgment of a
court of competent jurisdiction or (b) contain or make use of Technical
Developments.
2.03 "Licensed Process(es)" means processes which, in the course of
being practiced, would, in the absence of this Agreement, (a) infringe one or
more claims of the Licensed Patent Rights that have not been held invalid or
unenforceable by an unappealed or unappealable judgment of a court of competent
jurisdiction or (b) contain or make use of Technical Developments.
2.04 "Technical Developments" means all physical embodiments of
Licensed Patent Rights including technical data, drawings, and research
information, including all progeny and derivative works thereof, developed by or
under the supervision of Xx. Xxxx Xxxxxxxx ("Xx. Xxxxxxxx").
2.05 "Technical Information" means all ideas, know-how, research
information, methods, procedures or processes developed by or under the
supervision of Xx. Xxxxxxxx and owned by WU which is not in the public domain
and which contributes to the practice of the Licensed Patent Rights and the
marketing of Licensed Products.
2.06 "Territory" means the United States and Japan.
2.07 "Contract Year" means the one year period beginning with the
Effective Date of this Agreement and each one year period thereafter.
2.08 "Net Sales" means the total actual gross receipts for sales of
Licensed Products or practice of Licensed Processes by or on behalf of ATHENA or
its sublicensees, and from leasing, renting, or otherwise making Licensed
Products available to others without sale or
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other dispositions, whether invoiced or not, less returns and allowances
actually granted, freight out, taxes or excise duties imposed on the transaction
(if separately invoiced), and wholesaler and cash discounts in amounts customary
in the trade. No deductions shall be made for commissions paid to individuals,
whether they be with independent sales agencies or regularly employed by ATHENA,
or sublicensees, and on its payroll, or for the cost of collections.
2.09 "First Commercial Sale" means the initial transfer by or on behalf
of ATHENA or its sublicensees of Licensed Products or the initial practice of a
Licensed Process by or on behalf of ATHENA or its sublicensees in exchange for
cash or some equivalent to which value can be assigned for the purpose of
determining Net Sales.
2.10 "Government" means the government of the United States of
America.
2.11 "Field of Use" means the use of Licensed Products as research
reagents and human diagnostics.
3. GRANT OF RIGHTS
3.01 Subject to the terms and conditions of this Agreement, WU hereby
grants and ATHENA accepts, an exclusive license under the Licensed Patent Rights
in the Territory to make, use, and sell Licensed Products in the Field of Use
and to practice and have practiced any Licensed Processes in the Field of Use.
3.02 Subject to the terms and conditions of this Agreement, WU hereby
grants and ATHENA accepts an exclusive license in the Territory to make, use and
sell Technical Developments in the Field of Use.
3.03 Subject to the terms and conditions of this Agreement, WU hereby
grants and ATHENA accepts, subject to the terms and conditions of this
Agreement, an exclusive license in the Territory to make, use and sell Technical
Information in the Field of Use.
3.04 This Agreement confers no license or rights by implication,
estoppel, or otherwise under any patent applications or patents of WU other than
Licensed Patent Rights regardless of whether such patents are dominant or
subordinate to Licensed Patent Rights.
3.05 ATHENA hereby grants to WU a non-exclusive, paid-up license and
right to practice Licensed Patent Rights, Technical Developments and Technical
Information for clinical testing, not to exceed [ ]* sulfatide diagnostic tests
per year, and [ ]* GALOP diagnostic tests per year. WU may also use such tests
for internal research purposes.
3.06 ATHENA further grants to WU a non-exclusive license and right to
use all information, data and reports developed by ATHENA or by third parties
acting on behalf of or
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under authorization from ATHENA for internal research purposes, subject to
patient confidentiality. WU will not provide any such information, data or
reports to third parties.
3.07 In addition to the reserved license of Section 3.06 above, WU
reserves the right to grant nonexclusive licenses to academic and other
non-profit research institutions to make and to use the inventions defined by
the Licensed Patent Rights solely for purposes of research involving the
inventions themselves, and not for purposes of clinical diagnosis or in lieu of
purchase if the inventions are avaable as commercial products for research
purposes. The purpose of this research license is to encourage basic research.
3.08 ATHENA shall ensure that "Patent Pending" and/or the Licensed
Patent Rights number for issued patents appears on all Licensed Products or
their labels.
3.09 For each year that ATHENA pays to WU the annual minimum royalty
required under Article 6, WU hereby grants to ATHENA a right of first refusal to
exclusively license new inventions by Xx. Xxxxxxxx, or WU employees under Xx.
Xxxxxxxx'x supervision, in the field of autoantibodies in neurological
disorders. Such right of first refusal shall expire ninety (90) days after
ATHENA receives written disclosure of such new invention from WU.
3.10 For each year that ATHENA pays to WU the annual minimum royalty
required under Article 6, Xx. Xxxxxxxx will provide up to eight (8) days of
advice and support to ATHENA for grand round talks, development of audio or
video tapes and other activities to be mutually agreed upon, in support of the
field of autoimmune peripheral neuropathies. Such support will be at no charge
for the first Contract Year, and thereafter, at a reasonable per diem rate to be
agreed upon, except reimbursement of out-of-pocket expenses, which shall be
reimbursed within thirty (30) days after receipt of invoices from Xx. Xxxxxxxx.
3.11 ATHENA agrees to provide Xx. Xxxxxxxx with positive sera and
clinical information concerning each patient, subject to patient confidentiality
and the availability of such data to ATHENA.
4. SUBLICENSING
4.01 Upon written approval by WU, which approval will not be
unreasonably withheld, ATHENA may enter into sublicensing agreements under the
Licensed Patent Rights.
4.02 ATHENA agrees that any sublicenses granted by it shall provide
that the obligations to WU of Sections 5.01, 5.02, 8.01, 10.01, 10.02, 12.04,
12.05 and 13.08 of this Agreement shall be binding upon the sublicensee as if it
were a party to this Agreement. ATHENA further agrees to attach copies of these
Sections to all sublicense agreements.
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4.03 Any sublicenses granted by ATHENA shall provide for the
termination of the sublicense, or the conversion to a license directly between
such sublicensees and WU, at the option of the sublicensee, upon termination of
this Agreement under Article 13. Such conversion is subject to WU approval and
contingent upon acceptance by the sublicensee of the remaining provisions of
this Agreement.
4.04 ATHENA agrees to forward to WU a copy of each fully executed
sublicense agreement postmarked within sixty (60) days of the execution of such
agreement.
5. RESERVED GOVERNNIENT RIGHTS
5.01 Should the Government jointly fund research supporting the
development of Licensed Patent Righits or new inventions, WU shall reserve on
behalf of the Government an irrevocable, nonexclusive, nontransferable,
royalty-free license for the practice of Licensed Patent Rights throughout the
world by or on behalf of the Government and on behalf of any foreign government
or international organization pursuant to any existing or future treaty or
agreement to which the Government is a signatory.
5.02 ATHENA agrees that License Products used or sold in the United
States embodying Licensed Patent Rights or products produced through use of
Licensed Processes developed with Government funding shall be manufactured
substantially in the United States, unless a written waiver is obtained in
advance from WU.
6. ROYALTIES AND REIMBURSEMENT
6.01 Within thirty (30) days after the Effective Date, ATHENA will pay
to WU a nonrefundable license issue fee of $[ ]*, which shall be creditable
against earned royalties during the first Contract Year.
6.02 For the second and each subsequent Contract Year, ATHENA agrees to
pay to WU a nonrefundable annual minimum royalty of $[ ]* for each Contract Year
until separate patent claims under the Licensed Patent Rights for the detection
of each of the IgM and IgG antibodies for sulfatide issue in the United States.
Starting with the next Contract Year after such patent issues, then the
nonreftmdable, annual minimum royalty shall be $[ ]* per Contract Year. The
annual minimum royalty shall be fully creditable against earned royalties under
6.03(a) in the Contract Year so earned. No carry forward of annual minimum
royalty credits shall be allowed. The minimum annual royalty is due and payable
within thirty (30) days of the end of each Contact Year.
6.03 ATHENA and its sublicensees agree to pay WU earned royalties as
follows:
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(a) With regard to tests for autoantibodies to sulfatide based on
analysis of IgM or IgG or their combination:
(i) During the first Contract Year, an earned royalty of
[ ]%* of Net Sales;
(ii) Until the date of issuance of the separate patent(s)
described in 6.02, an earned royalty of [ ]%* of Net Sales;
(iii) Following the issuance of the patent claims in (ii), an
earned royalty of [ ]%* of annual Net Sales until such annual Net Sales
reach $[ ]*;
(iv) For annual Net Sales in excess of $1 million in (iii),
an earned royalty of [ ]%* of annual Net Sales.
(b) with regard to the GALOP test, an earned royalty of [ ]%* of
Net Sales.
6.04 No multiple royalties shall be payable because any Licensed
Products or Licensed Processes are covered by more than one of the Licensed
Patent Rights.
6.05 To the extent commercially practicable, ATHENA shall invoice, list
and xxxx any Licensed Product and non-Licensed Product as a separate item on
invoices and reports to customers. In the event ATHENA offers a non-assay
service in combination with the offer of any Licensed Product ("Combination
Service"), then the Net Sales revenue, for the purposes of determining royalties
due WU, shall be determined by multiplying the Net Sales revenue of such
Combination Service by the fraction A/(A+B), where A is the Net Sales revenue of
the Licensed Product then charged by ATHENA for such Licensed Product, when
performed and billed separately and B is the Net Sales revenue for the
non-Licensed Product then charged by ATHENA for such non-Licensed Product, when
performed and billed separately.
7. DOMESTIC AND FOREIGN PATENT FILING, PROSECUTION, AND MAINTENANCE
7.01 WU agrees to take responsibility for, and to diligently pursue the
preparation, filing, prosecution, and maintenance of any and all patent
applications or patents included in the Licensed Patent Rights, including
without limitation, any applications under 7.04, and shall furnish copies of
relevant patent related documents to ATHENA. ATHENA shall have the right to
approve WU patent counsel, such approval not to be unreasonably withheld.
7.02 Each party shall promptly inform the other as to all matters that
come to its attention that may affect the preparation, filing, prosecution, or
maintenance of the Licensed Patent Rights and permit each other to provide
comments and suggestions, as far in advance as is
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practical with respect to the preparation, filing, and prosecution of Licensed
Patent Rights, which comments and suggestions shall be considered by the other
party.
7.03 ATHENA agrees to reimburse WU, within thirty (30) days after
receipt of an invoice from WU, for the following reasonable patent expenses
incurred after the Effective Date:
(a) All maintenance costs and fees for issued U.S. Patent
No. 5,443,952;
(b) Except for patent filing expenses as provided in Section 7.04, all
prosecution and maintenance costs of divisional patent applications and issued
patents for sulfatide IgG and IgM S/Ns TBD;
(c) All filing, prosecution and maintenance fees for US and Japanese
patent applications and issued patents for the GALOP diagnostic test currently
contained in continuation in part patent application S/Ns 08/137,895 and
08/481,144.
7.04 WU shall pay for the preparation and initial filing fees of
divisional applications for sulfatide IgG and IgM autoantibody diagnostic tests.
7.05 With regard to the GALOP diagnostic test, ATHENA shall be entitled
to a credit of patent prosecution and maintenance expenses for patent
applications and issued patents against the earned royalties of 6.03(b) for all
patent filing and maintenance costs paid by ATHENA to WU, exceeding $[ ]*.
8. RECORD KEEPING
8.01 ATHENA agrees to keep accurate and correct records of Licensed
Products made, used, or sold and Licensed Processes practiced under this
Agreement appropriate to determine the amount of royalties due WU. Such records
shall be retained for at least five (5) years following a given reporting
period. They shall be available during normal business hours for inspection at
the expense of WU by an accountant or other designated auditor selected by WU
and reasonably approved by ATHENA for the sole purpose of verifying reports and
payments thereunder. The accountant or auditor shall only disclose to WU
information relating to the accuracy of reports and payments made under this
Agreement. If an inspection shows an underreporting or underpayment in excess of
[ ]%* for any Contract Year, then ATHENA shall reimburse WU for the cost of the
inspection at the time ATHENA pays the unreported royalties, including any late
charges as required by Section 9.07 of this Agreement. All payments required
under this Section shall be due within thirty (30) days after receipt by ATHENA
of a written invoice from WU.
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9. REPORTS ON PROGRESS, SALES, AND PAYMENTS
9.01 Ninety (90) days after the Effective Date ATHENA will provide to
WU a written commercialization plan ("Commercial Development Plan") under which
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ATHENA intends to bring the subject matter of the Licensed Patent Rights into
commercial use. The Commercial Development Plan will be incorporated by
reference into this Agreement.
9.02 Until First Commercial Sale, ATHENA shall provide written annual
reports on its product development progress or efforts to commercialize each
diagnostic test under the Commercial Development Plan for IgG, IgM and GALOP
within sixty (60) days after the start of each Contract Year. These progress
reports shall include, but not be limited to: progress on research and
development, status of applications for regulatory approvals, manufacturing,
sublicensing., and marketing efforts during the preceding calendar year, as well
as plans for the present calendar year. If reported progress differs
substantially from that projected in the Commercial Development Plan, ATHENA
shall explain the reasons for such differences. ATHENA may propose amendments in
any such annual report to the Commercial Development Plan, acceptance of which
by WU may not unreasonably be denied.
9.03 ATHENA shall report to WU the date of the First Commercial Sale in
each country in the Territory within thirty (30) days of such occurrence.
9.04 ATHENA shall submit to WU a royalty report on a semi-annual basis,
within thirty (30) days after the close of each six (6) month Contract Year
period. This report shall set forth for the preceding six (6) months the amount
of the Licensed Products sold or Licensed Processes practiced by or on behalf of
ATHENA in each country within the Territory, the Net Sales, and a calculation of
royalties payable. With each such royalty report, ATHENA shall submit payment of
the earned royalties due. If no earned royalties are due to WU for any reporting
period, the written report shall so state. The royalty report shall be certified
as correct by an authorized officer of ATHENA.
9.05 ATHENA agrees to forward semi-annually to WU a copy of such
reports received by ATHENA from its sublicensees during the preceding half-year
period as shall be pertinent to a royalty accounting to WU by ATHENA for
activities under the sublicense.
9.06 Royalties due under Article 6 shall be paid in U.S. dollars. For
conversion of foreign currency to U.S. dollars, the conversion rate shall be the
rate quoted in the Wall Street Journal on the day that the payment is made. WU
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checks and bank drafts shall be drawn on United States banks and shall be
payable to WU. Any taxes or other expenses incurred in the transfer or
conversion to U.S. dollars shall be paid entirely by ATHENA. All royalty
payments due under this Agreement shall be mailed to the following address:
Washington University, Xxx Xxxxxxxxx Xxxxx, Xxxxxx Xxx 0000, Xx. Xxxxx, Xxxxxxxx
00000.
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9.07 Late charges will be applied to any overdue payments at a rate of
[ ]* as of the date such payment is due, plus [ ]%*, for the
period that payment is due until the time payment is actually received. The
payment of such late charges shall not prevent WU from exercising any other
rights it may have as a consequence of the lateness of any payment.
9.08 During the term of the Agreement, and for a period of five (5)
years following the expiration or earlier termination hereof, each party shall
maintain in confidence all information of the other party (including royalty
reports, test results and samples) disclosed by the other party (the
"Confidential Information"), and shall not disclose or grant the use of the
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Confidential Information except on a need-to-know basis to those directors,
officers, affiliates, employees, or representatives, to the extent such
disclosure is reasonably necessary in connection with such party's activities as
expressly authorized by the Agreement, or unless expressly approved in advance
by the other party. Each party shall notify the other promptly upon discovery of
any unauthorized use or disclosure of the other party's Confidential
Information.
9.09 The confidentiality obligations contained in Section 9.08 shall
not apply to the extent that (a) any receiving party (the "Recipient") is
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required (i) to disclose information by Law, order or regulation of a
governmental agency or a court of competent jurisdiction, or (ii) to disclose
information to any governmental agency for purposes of obtaining approval to
test or market a Licensed Product, provided in either case that the Recipient
shall provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof; or (b) the Recipient can demonstrate that (i) the disclosed
information was public knowledge at the time of such disclosure to the
Recipient, or thereafter became public knowledge, other than as a result of
actions of the Recipient in violation hereof; (ii) the disclosed information was
rightfully known by the Recipient (as shown by its written records) prior to the
date of disclosure to the Recipient by the other party hereunder; or (iii) the
disclosed information was disclosed to the Recipient on an unrestricted basis
from a source unrelated to any party to the Agreement and not under a duty of
confidentiality to the other party. Except as otherwise provided immediately
above, WU and ATHENA shall not disclose any terms or conditions of this
Agreement to any third party without the prior consent of the other party.
10. PERFORMANCE
10.01 ATHENA shall be diligent and shall use its reasonable efforts to
introduce the Licensed Products into the commercial market or apply the Licensed
Processes to commercial use as listed herein. "Reasonable efforts" for the
purpose of this provision shall include, but not be limited to, substantial
adherence to the Commercial Development Plan. The efforts of a sublicensee shall
be considered the efforts of ATHENA. As part of the Commercial Development Plan,
ATHENA hereby agrees to cornmercially introduce the GALOP diagnostic test within
one (1) year after the Effective Date.
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10.02 Upon the First Commercial Sale, until the expiration of this
Agreement, ATHENA shall use its reasonable efforts to keep Licensed Products and
Licensed Processes reasonably accessible to the public.
10.03 ATHENA shall be considered diligent in its sales of Licensed
Products, sulfatide IgG and IgK, provided ATHENA pays its annual minimum royalty
due in any Contract Year. For the GALOP diagnostic test, ATHENA shall be
considered diligent provided that the GALOP diagnostic test is made reasonably
available in the Territory.
11. INFRINGEMENT AND PATENT ENFORCEMENT
11.01 If ATHENA or WU has actual notice of infringement or possible
infringement of the Licensed Patent Rights, the parties shall notify each other
and confer to determine in good faith an appropriate course of action to enforce
the Licensed Patent Rights or otherwise xxxxx the infringement thereof.
11.02 ATHENA, at its sole expense and in its sole discretion, shall
have the right to (i) determine and take the appropriate course of action to
enforce the Licensed Patent Rights or otherwise xxxxx the infringement thereof,
(ii) take or refrain from taking appropriate action to enforce the Licensed
Patent Rights, (iii) initiate and control any litigation or other enforcement
action, including without limitation any declaratory relief action asserting the
invalidity or noninfringement of any of the Licensed Patent Rights (in its own
name or, if required by applicable law, in the came of WU) and (iv) enter into,
or permit, the settlement of any such litigation or other enforcement action
regarding the Licensed Patent Rights, and shall consider, in good faith, the
interest of WU in so doing. At any time after receipt of notice, of ATHENA's
intent to file or respond to any such suit under this Section, WU shall have the
right to join such suit, and shall pay its own fees and costs if it chooses to
do so. WU shall join as a necessary party in any such suit if required to do so
by applicable law. If WU is joined as a necessary party without its consent,
ATHENA will pay reasonable fees and costs actually incurred by WU upon the
presentation of detailed invoices. ATHENA will keep WU reasonably apprised of
the status and progress of any such litigation.
11.03 If ATHENA does not, within one hundred and twenty (120) days of
receipt of written request to do so from WU, xxxxx the infringement or file suit
to enforce the Licensed Patent Rights against at least one infringing party, WU
shall have the right to take or refrain from taking appropriate action to
enforce the Licensed Patent Rights, to initiate and control any litigation or
other enforcement action and enter into, or permit, the settlement of any such
litigation or other enforcement action regarding the Licensed Patent Rights, and
shall consider, in good faith, the interests of ATHENA in so doing. WU will keep
ATHENA reasonably apprised of the status and progress of any such litigation. At
any time after receipt of notice of WU's intent to file any such suit under this
Section, ATHENA shall have the right to join in such suit and shall pay its own
fees and costs if it chooses to do so.
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11.04 ATHENA shall have the right to credit all actual, reasonable,
external expenses (including reasonable attorneys fees and costs), incurred by
ATHENA and its affiliates in the planning, filing and prosecution or defense of
any suit or other enforcement action under this Section, against any royalties
owning to WU pursuant to Section 6.03(a) or 6.03(b), as the case may be, until
such time as ATHENA has taken a credit equal to the aggregate amount of such
expenses, except that such credit may not exceed in any Contract Year, [ ]%* of
the royalties owned by ATHENA for that Contract Year, and in any event may not
reduce the royalties below the minimum royalties provided in Section 6.02.
Expenses not so credited may be carried over and credited in subsequent Contract
Years on the same basis.
11.05 All amounts recovered upon the final judgment or settlement of
any such suit or other enforcement action under this Section regarding the
Licensed Patent Rights shall be shared as follows: first, to WU and ATHENA, pro
rata, for reimbursement of expenses actually incurred by each of them in
accordance with this Section in the infringement proceeding to which the
settlement or recovery relates (to the extent not already recovered by ATHENA by
credits against royalties, as provided in the above section); and thereafter,
equally between WU and ATHENA.
11.06 WU and ATHENA shall fully cooperate with each other in the
planning, filing and prosecution of any suit or other enforcement action under
this Section and execute all such documents as may be reasonably necessary in
connection therewith.
12. NEGATION OF WARRANTIES, INDEMNIFICATION AND INSURANCE
12.01 WU offers no warranties other than those specified in Article 1.
12.02 WU does not warrant the validity of the Licensed Patent Rights
and makes no representations whatsoever with regard to the scope of the Licensed
Patent Rights, or that the Licensed Patent Rights may be exploited without
infringing other patents or other intellectual property rights of third parties.
WU does not represent that it will commence legal actions against third parties
infringing the Licensed Patent Rights.
12.03 WU MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS
OF THE LICENSED PATENT RIGHTS.
12.04 ATHENA shall indemnify, defend and hold harmless WU, their
trustees, officers and employees, against any liability, damage, loss or expense
incurred by or imposed upon WU in connection with any claims, suits, actions,
demands or judgments arising out of (i) the design, production, manufacture,
sale, use in commerce, lease, barter, or promotion by ATHENA or by ATHENA
subsidiaries or agents of ATHENA, (ii) any Licensed Product, process or service
relating to or developed pursuant to this Agreement by ATHENA; or (iii)
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any other activities to be carried out pursuant to this Agreement including the
assertion of Licensed Patent Rights against third parties, except to the extent
of any gross negligence or willful misconduct of WU, its officers, employees or
representatives.
12.05 Throughout the term of the Agreement, ATHENA shall, at its sole
cost and expense, procure and maintain comprehensive general liability insurance
with product liability coverage in an amount not less than $[ ]* per incident
and $[ ]* annual aggegate, with such excess coverage as ATHENA may deem
reasonable and appropriate. Within ten (10) days of the date of this Agreement,
ATHENA will provide WU with a certificate of insurance in the name of WU. The
minimum amounts of insurance coverage stated above shall not be construed to
create a limit of ATHENA's liability with respect to any indemnification
obligations under this Agreement. ATHENA will give written notice to WU in the
event of cancellation or termination of such liability or excess coverage. All
carriers of such insurance shall be of nationally recognized standing, and shall
maintain ratings no less than those currently in effect for ATHENA's current
insurance carrier, unless reasonably acceptable to WU. If ATHENA elects to
self-insure, all or part of the limits described above (excluding deductibles or
retentions of less than $[ ]* annual aggregate), such self-insurance program
must be reasonably acceptable to WU.
13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS
13.01 This Agreement is effective when signed by all parties and shall
extend to the expiration of the last to expire of the Licensed Patent Rights
unless sooner terminated as provided in this Article 13.
13.02 In the event that ATHENA is in default in the performance of any
material obligations under this Agreement, and if the default has not been
remedied within ninety (90) days after the date of notice in writing of such
default, WU may terminate this Agreement by written notice.
13.03 At least thirty (30) days prior to filing a petition in
bankruptcy, ATHENA must inform WU in writing of its intention to file the
petition in bankruptcy or of a third party's intention to file an involuntary
petition in bankruptcy.
13.04 In the event that ATHENA becomes insolvent, files a petition in
bankruiptcy, has such a petition filed against it, determines to file a petition
in bankruptcy, or receives notice of a third party's intention to file an
involuntary petition in bankruptcy, ATHENA shall immediately notify WU in
writing. Furthermore, WU shall have the right to terminate this Agreement by
giving ATHENA written notice. Termination of this Agreement is effective upon
ATHENA's receipt of the written notice.
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13.05 ATHENA shall have a unilateral right to terminate this Agreement
and/or any licenses in any country by giving WU sixty (60) days' written notice
to that effect.
13.06 WU shall specifically have the right to terminate or render
non-exclusive, at its option, this Agreement, if WU determines that ATHENA: (a)
is not executing the Commercial Development Plan submitted with its request for
a license and ATHENA cannot otherwise demonstrate to WU's satisfaction that
ATHENA has taken, or can be expected to take within a reasonable time, effective
steps to achieve practical application of the Licensed Products or Licensed
Processes; (b) has not been reasonably diligent in its pursuit of the milestones
in the Product Plan; (c) has willfully made a false statement of, or willfully
omitted, a material fact in the license application or in any report required by
the license agreement; (d) has committed a substantial breach of a covenant or
agreement contained in the license; (e) is not keeping Licensed Products or
Licensed Processes reasonably available to the public after commercial use
commences; or, (f) cannot reasonably justify a failure to comply with the
domestic production requirement of Section 5.02 unless waived. In making this
determination, WU will take into account the normal course of such commercial
development programs conducted with sound and reasonable business practices and
judgment and the annual reports submitted by ATHENA under Sections 9.02 and
9.04. Prior to invoking this right, WU shall give written notice to ATHENA
providing ATHENA specific notice of, and a ninety (90) day opportunity to
respond to, WU's concerns as to the previous items (a) through (f). If ATHENA
fails to reasonably alleviate WU's concerns as to the previous items (a) through
(f) or fails to initiate corrective action to WU's reasonable satisfaction, WU
may terminate this Agreement.
13.07 When the public health and safety so require, and after written
notice to ATHENA providing ATHENA a sixty (60) day opportunity to respond, WU
shall have the right to require ATHENA to grant sublicenses to responsible
applicants, on reasonable terms, in any Field of Use under the Licensed Patent
Rights, unless ATHENA can reasonably demonstrate that the granting of the
sublicense would not materially increase the availability to the public of the
subject matter of the Licensed Patent Rights. WU will not require the granting
of a sublicense unless the responsible applicant has first negotiated in good
faith with ATHENA.
13.08 Within ninety (90) days of termination of this Agreement under
this Article 13 or expiration under Section 13.01, a final report shall be
submitted by ATHENA. Any royalty payments, including those related to patent
expense, due to WU shall become immediately due and payable upon termination or
expiration. If terminated under this Article 13, sublicensees may elect to
convert their sublicenses to direct licenses with WU pursuant to Section 4.03.
13.09 Notwithstanding anything in this Agreement to the contrary, WU's
remedies under Section 13.06 must be exercised solely and separately, as between
IgG/IgM sulfatide
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antibody tests, on the one hand, and GALOP, on the other, according to the
actual alleged breach or default.
14. GENERAL PROVISIONS
14.01 Neither Party may waive or release any of its rights or interests
in this Agreement except in writing. The failure of WU to assert a right
hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right by WU or excuse a similar
subsequent failure to perform any such term or condition by ATHENA.
14.02 This Agreement constitutes the entire agreement between the
Parties relating to the subject matter of the Licensed Patent Rights, and all
prior negotiations, representations, agreements, and understandings are merged
into, extinguished by, and completely expressed by this Agreement.
14.03 The provisions of this Agreement are severable, and in the event
that any provision of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of law, such determination shall not in
any way affect the validity or enforceability of the remaining provisions of
this Agreement.
14.04 If either Party desires a modification to this Agreement, the
Parties shall, upon reasonable notice of the proposed modification by the Party
desiring the change, confer in good faith to determine the desirability of such
modification. No modification will be effective until a written amendment is
signed by the signatories to this Agreement or their designees.
14.05 The construction, validity, performance, and effect of this
Agreement shall be governed by Federal law as applied by the Federal courts in
the State of Missouri.
14.06 All notices required or permitted by this Agreement shall be
given by prepaid, first class, registered or certified mail properly addressed
to the other Party at the address designated on the following Signature Page, or
to such other address as may be designated in writing by such other Party, and
shall be effective as of the date of the postmark of such notice.
14.07 This Agreement shall not be assigned by ATHENA except (a) with
the prior written consent of WU, such consent to be reasonably given; or (b) as
part of a sale or transfer of substantially the entire business of ATHENA
relating to operations which concern this Agreement. ATHENA shall notify WU
within ten (10) days of any assignment of this Agreement by ATHENA.
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14.08 ATHENA agrees in its use of any WU-supplied materials to comply
with all applicable statutes, regulations, and guidelines, including Public
Health Service and National institutes of Health regulations and guidelines.
ATHENA agrees not to use the materials for research involving human subjects or
clinical trials of the United States without notifying WU, in writing, of such
research or trials and complying with the applicable regulations of the appro
priate Government authorities. Written notification to WU of research involving
human subjects or clinical trials of the United States shall be given no later
than sixty (60) days prior to commencement of such research or trials.
14.09 ATHENA acknowledges that it is subject to and agrees to abide by
the United States laws and regulations (including the Export Administration Act
of 1979 and Arms Export Control Act) controlling the export of technical data,
computer software, laboratory prototypes, biological material, and other
commodities. The transfer of such items may require a license from the cognizant
agency of the U.S. Government or written assurances by ATHENA that it shall not
export such items to certain foreign countries without prior approval of such
agency. WU neither represents that a license is or is not required or that, if
required, it shall be issued.
14.10 All Licensed Products manufactured in, shipped to, or sold in
other countries shall be marked in such a manner as to preserve WU patent rights
in such countries.
14.11 By entering into this Agreement, WU does not directly or
indirectly endorse any product or service provided, or to be provided, by ATHENA
whether directly or indirectly related to this Agreement. ATHENA shall not state
or imply that this Agreement is an endorsement by WU or its employees.
Additionally, ATHENA shall not use the names of WU or its employees in any
advertising, promotional, or sales literature without the prior written consent
of WU.
14.12 The Parties agree to attempt to settle amicably any controversy
or claim arising under this Agreement or a breach of this Agreement. Any dispute
or claim arising out of this Agreement that cannot be settled by and between the
Parties to their mutual satisfaction within a reasonable period of time shall be
submitted to non-binding arbitration in St. Louis, Missouri under the Commercial
Arbitration Rules of the American Arbitration Association by one arbitrator
appointed in accordance with said Rules. The arbitrator shall apply Missouri law
to the merits of any dispute or claim, without reference to rules of conflicts
of law. Judgment on the award rendered by the arbitrator may be entered in any
court having jurisdiction thereof. Either party may file an action in a court of
competent jurisdiction for a de novo hearing regarding such arbitrated disputes.
The parties agree that decisions of the arbitrator are admissible and discovery
conducted during arbitration may be used in such action. Should the court
substantially uphold the findings of the arbitrator, the party seeking the de
novo hearing shall pay all parties costs involved including reasonable
attorney's fees.
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14.13 Sections 4.03, 8.01, 9.06, 9.07, 12.01-12.05, and 14.12 of this
Agreement shall survive termination of this Agreement.
FOR WASHINGTON UNIVERSITY:
By: /s/ X.X. Xxxxxx
---------------------------------------------
Name: X.X. Xxxxxx
Title: Director, Technology Management
FOR ATHENA DIAGNOSTICS, INC.
By: /s/ Xxxxxx Xxxxxxxx
---------------------------------------------
Name: Xxxxxx Xxxxxxxx
Title: President
APPENDIX A
LICENSED PATENT RIGHTS
ISSUED UNITED STATES PATENTS
US Patent No. 5,443,952
PENDING UNITED STATES PATENTS
Patent Application S/N 07/743,005 (abandoned)
Patent Application S/N 07/925,926 (abandoned) - Continuation of 07/743,005
Patent Application S/N 08/137,895 (pending) - Continuation in Part of 07/925,926
Patent Application S/N 08/481,144 (pending) - Continuation in Part of 08/137,895
Divisional Patent Application, S/N TBD - IgG and IgM independent claims.
-2-
FIRST AMENDMENT TO PATENT LICENSE AGREEMENT
THIS FIRST AMENDMENT TO PATENT LICENSE AGREEMENT is effective December
17, 1997, by and between Washington University ("WU"), an educational
institution and corporation of the State of Missouri, with an address of Xxx
Xxxxxxxxx Xxxxx, Xx. Xxxxx, Xxxxxxxx 00000, and Athena Diagnostics, Inc., a
Massachusetts corporation, with an address of Four Biotech Park, 000 Xxxxxxxxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("ATHENA").
WHEREAS, WU and ATHENA entered into a Patent License Agreement
effective April 17, 1996 (the "License Agreement");
-----------------
WHEREAS, WU and ATHENA desire to extend the terms of the License
Agreement, in the manner hereinafter set forth;
NOW, THEREFORE, in consideration of the mutual covenants contained
herein and for good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the parties hereby agree as follows:
The Patent License Agreement. Except as specifically set forth herein
----------------------------
in this First Amendment to Patent License Agreement (hereinafter "First
-----
Amendment"), the parties hereby ratify and confirm each and every term,
---------
representation, warranty, covenant and condition of the License Agreement which
shall remain in full force and effect; provided, however, that in the event of
-------- -------
any conflict between the License Agreement and this First Amendment, this First
Amendment shall govern and control.
Background. Paragraphs 1.06 and 1.07 shall be added to the License
----------
Agreement as follows:
1.06 WU is the owner of the XXXXX xxxx (the "Xxxx") in connection with
the Licensed Products and Licensed Process (defined below), including
diagnostic services incorporating an assay for Gait Disorder
Auto-Antibody Late Onset Polyneuropathy.
1.07 WU desires to grant and ATHENA desires to acquire a license to
use the Xxxx in connection with diagnostic services incorporating the
assay for Gait Disorder Auto-Antibody Late Onset Polyneuropathy (the
"Licensed Services") under the terms and conditions provided herein.
Trademark Filing, Prosecution and Maintenance. Section 7a shall be
---------------------------------------------
added to the License Agreement as follows:
7a. TRADEMARK FILING, PROSECUTION AND MAINTENANCE.
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7a.01 Subject to the terms and conditions of this Agreement, WU hereby
grants and ATHENA accepts, an exclusive, paid-up, license to use the
Xxxx in the Territory in connection with the Licensed Services, except
that WU reserves the right to use the Xxxx in connection with ATHENA's
grant back of rights under Section 3.05 of the License Agreement.
ATHENA acknowledges that its use of the Xxxx will not create in it any
right, title or interest in or to the Xxxx other than as set forth
herein. ATHENA agrees to use the Xxxx in a manner that creates a
separate and distinct impression from any other trademark or service
xxxx that may be used by ATHENA in advertising or promotional
materials.
7a.02 ATHENA agrees, at its expense, on WU's behalf and in WU's name,
to take responsibility for, and to diligently pursue the preparation,
filing, prosecution and maintenance of U.S. federal trademark
applications with respect to the Xxxx. In addition, ATHENA may, in its
sole discretion, pursue the preparation, filing, prosecution and
maintenance of trademark applications with respect to the Xxxx in other
jurisdictions within the Territory. During the term of this Agreement
and any subsequent renewal thereof, ATHENA further agrees to take all
steps required to maintain any registrations that result from said
applications. At ATHENA's request, WU agrees to do all lawful acts
which may be required for filing, prosecuting and maintaining said
applications and the registrations issuing therefrom. ATHENA shall
furnish copies of relevant trademark-related documents to WU. WU will
retain ownership of the Xxxx, and any applications or registrations
therefor.
7.a03 Given the parties' mutual interest in the Xxxx, the parties agree
to promptly inform each other as to all matters that may have a
material impact on the Xxxx, or any applications or registrations
therefor. Communications in this regard will be made as far in advance
as is practical, allowing each party the opportunity to comment and/or
make suggestions with respect thereto. It is understood, however, that
WU, as owner of the Xxxx, has the right to make all final decisions
concerning the Xxxx and any corresponding applications or registrations
therefor.
7.a04 ATHENA shall use the Xxxx in connection with the Licensed
Services in accordance with the guidelines and directions furnished by
WU, as set forth in the License Agreement and the patents and patent
applications attached thereto as Appendix A. ATHENA will permit WU, or
its designated representative, to inspect ATHENA's facility or
facilities at all reasonable times, for the purpose of ascertaining or
determining the quality of services provided in con-
-4-
nection with the Xxxx. WU shall be the sole judge of whether or not
ATHENA has met or is meeting the standards of quality so established.
7.a05 The provisions of Sections 4.01 to 4.04 of the License Agreement
shall apply with equal force and effect to the rights granted herein to
the Xxxx. In addition, ATHENA agrees that any sublicenses granted by it
shall provide that Section 7.a04 shall be binding upon the sublicensee
as if it were a party to the Licnese Agreement. ATHENA agrees to attach
a copy of that Section to all sublicense agreements.
7.a06 The provisions of Sections 11.01 to 11.06 of the License
Agreement shall apply with equal force and effect to the rights granted
herein to the Xxxx.
7.a07 The license granted in this Section 7a to use the Xxxx in
connection with the Licensed Services shall terminate upon termination
or expiration of the License Agreement, provided, however, that ATHENA
-------- -------
may use the Xxxx for a period of six (6) months for ATHENA's
stock-on-hand promotional literature, stationery, packaging, and other
printed or written materials. However, if any such materials remain in
ATHENA's stock-on-hand after the six months, ATHENA agrees to destroy
all such materials, other than archival copies. Upon termination of the
license granted in this Section 7a, all trademark rights granted herein
shall immediately revert to WU, and any and all rights of ATHENA in the
Xxxx shall terminate. ATHENA shall no longer use or have the right to
use the xxxx, any variation or deviation thereof, or any work, xxxx, or
trade name confusingly similar thereto.
7.a08 WU hereby grants ATHENA a first option to negotiate in good faith
with ATHENA for an exclusive license to the XXXX after expiration of
the last to expire Licensed Patent Rights and the right to use the Xxxx
for no more than six (6) months during the negotiations under the
option. If no license to the Xxxx is granted or taken under the option,
then ATHENA may make reference in its promotional materials, and its
other written and printed materials to the Xxxx for a period of one (1)
year after expiration of the last to expire Licensed Patent Rigths to
advise its customers and prospective customers that the services
incorporating an assay for Gait Disorder Auto-Antibody Late Onset
Polyneuropathy was formerly known as the GALOP service.
This document sets forth the entire agreement between the parties as to
the subject matter of the First Amendment and supersedes any prior written or
oral or contemporaneous oral agreement with respect thereto.
-5-
IN WITNESS WHEREOF, WU and ATHENA hereby execute this First Amendment
to Patent License Agreement.
ATHENA DIAGNOSTICS, INC. WASHINGTON UNIVERSITY
By:/s/ Xxxxxx Xxxxxxxx By:/s/ Xxxxxxxx X. Xxxxxx
-------------------------------- -----------------------------------
Name: Xxxxxx Xxxxxxxx Name: Xxxxxxxx X. Xxxxxx, Ph.D.
Title: President Title: Vice Chancellor for Research
12/17/97
