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EXHIBIT 10.1
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT--EXCLUSIVE
COVER PAGE
For PHS internal use only:
Patent License Number: 268-L-99/0
Serial Number(s) of Licensed Patent(s) and/or Patent Application(s):
PCT/US99/ 17282 (F- 131-98/1): 60/094.690 (E- 131-98/0)
Licensee:
RegeneRx Biopharmaceuticals Inc..
Cooperative Research and Development Agreement (CRADA) Number (if
applicable):
MTA Crada C-l 14-1997/0
Additional Remarks:
Company did not exercise their option under the MTA-CRADA
License was granted under procedures for Exclusive Licenses not
pursuant to a CRADA. with full Notice and Comment Period
Public Benefit(s):
Under certain conditions as set forth in Para2raph 10.03. in the event
PHS sponsors clinical trials on behalf of Licensee, Licensee has
agreed to supply clinical grade thymosin a4 to the PHS sponsored
clinical trial at cost
This Patent License Agreement, hereinafter referred to as the "Agreement",
consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A
(List of Patent(s) and/or Patent Application(s)), Appendix B (Fields of Use and
Territory), Appendix C (Royalties), Appendix D (Modifications), Appendix E
(Benchmarks), and Appendix F (Commercial Development Plan).
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The Parties to this Agreement are:
1) The National Institutes of Health ("NIH"), the Centers for Disease
Control and Prevention ("CDC"), or the Food and Drug Administration
("FDA"), hereinafter singly or collectively referred to as "PHS",
agencies of the United States Public Health Service within the
Department of Health and Human Services ("DHHS"); and
2) RegeneRx Biopharmaceuticals Inc., a corporation of Delaware, having
offices at 0 Xxxxxxxx Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, XX 00000, and
having done business as Alpha 1 Biomedicals, Inc. a corporation of
Delaware having offices at 0 Xxxxxxxx Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx,
XX 00000 until December 14, 2000, hereinafter referred to as "Licensee".
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PHS PATENT LICENSE AGREEMENT--EXCLUSIVE
PHS and Licensee agree as follows:
1. BACKGROUND
1.01 In the course of conducting biomedical and behavioral research,
PHS investigators made inventions that may have commercial
applicability.
1.02 By assignment of rights from PHS employees and other inventors,
DHHS, on behalf of the United States Government, owns
intellectual property rights claimed in any United States and/or
foreign patent applications or patents corresponding to the
assigned inventions. DHHS also owns any tangible embodiments of
these inventions actually reduced to practice by PHS.
1.03 The Secretary of DHHS has delegated to PHS the authority to
enter into this Agreement for the licensing of rights to these
inventions.
1.04 PHS 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.
1.05 Licensee desires to acquire commercialization rights to certain
of these inventions in order to develop processes, methods,
and/or marketable products for public use and benefit.
2. DEFINITIONS
2.01 "Benchmarks" mean the performance milestones that are set forth
in Appendix E.
2.02 "Commercial Development Plan" means the written
commercialization plan attached as Appendix F.
2.03 "First Commercial Sale" means the initial transfer by or on
behalf of Licensee or its sublicensees of Licensed Products or
the initial practice of a Licensed Process by or on behalf of
Licensee or its sublicensees in exchange for cash or some
equivalent to which value can be assigned for the purpose of
determining Net Sales.
2.04 "Government" means the Government of the United States of
America.
2.05 "Licensed Fields of Use" means the fields of use identified in
Appendix B.
2.06 "Licensed Patent Rights" shall mean:
a) Patent applications (including provisional patent
applications and PCT patent applications) and/or patents
listed in Appendix A, 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;
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b) to the extent that the following contain one or more
claims directed to the invention or inventions disclosed
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; iv) priority patent application(s) of a)
above; and v) any reissues, reexaminations, and
extensions of all such patents;
c) to the extent that the following contain one or more
claims directed to the invention or inventions disclosed
in a) above: all counterpart foreign and U.S. patent
applications and patents to a) and b) above, including
those listed in Appendix A.
Licensed Patent Rights shall not include b) or c) above to the
extent that they contain one or more claims directed to new
matter which is not the subject matter disclosed in a) above.
2.07 "Licensed Process(es)" means processes which, in the course of
being practiced would, in the absence of this Agreement,
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.
2.08 "Licensed Product(s)" means tangible materials which, in the
course of manufacture, use, offer to sell, sale, or importation
would, in the absence of this Agreement, 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.
2.09 "Licensed Territory" means the geographical area identified in
Appendix B.
2.10 "Net Sales" means the total gross receipts for sales of Licensed
Products or practice of Licensed Processes by or on behalf of
Licensee or its sublicensees, and from leasing, renting, or
otherwise making Licensed Products available to others without
sale or other dispositions, whether invoiced or not, less
returns and allowances, packing costs, insurance costs, freight
out, taxes or excise duties imposed on the transaction (if
separately invoiced), and wholesaler and cash discounts in
amounts customary in the trade to the extent actually granted.
No deductions shall be made for commissions paid to individuals,
whether they be with independent sales agencies or regularly
employed by Licensee, or sublicensees, and on its payroll, or
for the cost of collections.
2.11 "Practical Application" means to manufacture in the case of a
composition or product, to practice in the case of a process or
method, or to operate in the case of a machine or system; and in
each case, under such conditions as to establish that the
invention is being utilized and that its benefits are to the
extent permitted by law or Government regulations available to
the public on reasonable terms.
2.12 "Research License" means a nontransferable, nonexclusive license
to make and to use the Licensed Products or Licensed Processes
as defined by the Licensed Patent Rights for purposes of
research and not for purposes of commercial manufacture or
distribution or in lieu of purchase.
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3. GRANT OF RIGHTS
3.01 PHS hereby grants and Licensee accepts, subject to the terms and
conditions of this Agreement, an exclusive license under the
Licensed Patent Rights in the Licensed Territory to make and
have made, to use and have used, to sell and have sold, to offer
to sell, and to import any Licensed Products in the Licensed
Fields of Use and to practice and have practiced any Licensed
Processes in the Licensed Fields of Use.
3.02 This Agreement confers no license or rights by implication,
estoppel, or otherwise under any patent applications or patents
of PHS other than Licensed Patent Rights regardless of whether
such patents are dominant or subordinate to Licensed Patent
Rights.
4. SUBLICENSING
4.01 Upon written approval by PHS, which approval will not be
unreasonably withheld, Licensee may enter into sublicensing
agreements under the Licensed Patent Rights.
4.02 Licensee agrees that any sublicenses granted by it shall provide
that the obligations to PHS of Paragraphs 5.01-5.04, 8.01,
10.01, 10.02, 12.05, and 13.07-13.09 of this Agreement shall be
binding upon the sublicensee as if it were a party to this
Agreement. Licensee further agrees to attach copies of these
Paragraphs to all sublicense agreements.
4.03 Any sublicenses granted by Licensee shall provide for the
termination of the sublicense, or the conversion to a license
directly between such sublicensees and PHS, at the option of the
sublicensee, upon termination of this Agreement under Article
13. Such conversion is subject to PHS approval and contingent
upon acceptance by the sublicensee of the remaining provisions
of this Agreement.
4.04 Licensee agrees to forward to PHS a copy of each fully executed
sublicense agreement postmarked within thirty (30) days of the
execution of such agreement. To the extent permitted by law, PHS
agrees to maintain each such sublicense agreement in confidence.
5. STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
5.01 (a) PHS reserves on behalf of the Government an irrevocable,
nonexclusive, nontransferable, royalty-free license for
the practice of all inventions licensed under the
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. Prior to the First Commercial
Sale, Licensee agrees to provide PHS reasonable
quantities of Licensed Products or materials made
through the Licensed Processes for PHS research use.
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(b) In the event that Licensed Patent Rights are Subject
Inventions made under a Cooperative Research and
Development Agreement (CRADA), Licensee grants to the
Government, pursuant to 15 U.S.C. 3710a(b)(1)(A), a
nonexclusive, nontransferable, irrevocable, paid-up
license to practice Licensed Patent Rights or have
Licensed Patent Rights practiced throughout the world by
or on behalf of the Government. In the exercise of such
license, the Government shall not publicly disclose
trade secrets or commercial or financial information
that is privileged or confidential within the meaning of
5 U.S.C. 552(b)(4) or which would be considered as such
if it had been obtained from a non-Federal party. Prior
to the First Commercial Sale, Licensee agrees to provide
PHS reasonable quantities of Licensed Products or
materials made through the Licensed Processes for PHS
research use.
5.02 Licensee agrees that products used or sold in the United States
embodying Licensed Products or produced through use of Licensed
Processes shall be manufactured substantially in the United
States, unless a written waiver is obtained in advance from PHS.
5.03 Licensee acknowledges that PHS may enter into future Cooperative
Research and Development Agreements (CRADAs) under the Federal
Technology Transfer Act of 1986 that relate to the subject
matter of this Agreement. Licensee agrees not to unreasonably
deny requests for a Research License from such future
collaborators with PHS when acquiring such rights is necessary
in order to make a Cooperative Research and Development
Agreement (CRADA) project feasible. Licensee may request an
opportunity to join as a party to the proposed Cooperative
Research and Development Agreement (CRADA).
5.04 (a) In addition to the reserved license of Paragraph 5.01
above, PHS reserves the right to grant nonexclusive
Research Licenses directly or to require Licensee to
grant nonexclusive Research Licenses on reasonable
terms. The purpose of this Research License is to
encourage basic research, whether conducted at an
academic or corporate facility. In order to safeguard
the Licensed Patent Rights, however, PHS shall consult
with Licensee before granting to commercial entities a
Research License or providing to them research samples
of materials made through the Licensed Processes.
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(b) In exceptional circumstances, and in the event that
Licensed Patent Rights are Subject Inventions made under
a Cooperative Research and Development Agreement
(CRADA), the Government, pursuant to 15 U.S.C.
37l0a(b)(l)(B), retains the right to require the
Licensee to grant to a responsible applicant a
nonexclusive, partially exclusive, or exclusive
sublicense to use Licensed Patent Rights in Licensee's
field of use on terms that are reasonable under the
circumstances; or if Licensee fails to grant such a
license, the Government retains the right to grant the
license itself. The exercise of such rights by the
Government shall only be in exceptional circumstances
and only if the Government determines (i) the action is
necessary to meet health or safety needs that are not
reasonably satisfied by Licensee; (ii) the action is
necessary to meet requirements for public use specified
by Federal regulations, and such requirements are not
reasonably satisfied by the Licensee; or (iii) the
Licensee has failed to comply with an agreement
containing provisions described in 15 U.S.C.
37l0a(c)(4)(B). The determination made by the Government
under this Article is subject to administrative appeal
and judicial review under 35 U.S.C. 203(2).
6. ROYALTIES AND REIMBURSEMENT
6.01 Licensee agrees to pay to PHS a noncreditable, nonrefundable
license issue royalty as set forth in Appendix C within thirty
(30) days from the date that this Agreement becomes effective.
6.02 Licensee agrees to pay to PHS a nonrefundable minimum annual
royalty as set forth in Appendix C. The minimum annual royalty
is due and payable on January 1 of each calendar year and may be
credited against any earned royalties due for sales made in that
year. The minimum annual royalty due for the first calendar year
of this Agreement may be prorated according to the fraction of
the calendar year remaining between the effective date of this
Agreement and the next subsequent January 1.
6.03 Licensee agrees to pay PHS earned royalties as set forth in
Appendix C.
6.04 Licensee agrees to pay PHS benchmark royalties as set forth in
Appendix C.
6.05 Licensee agrees to pay PHS sublicensing royalties as set forth
in Appendix C.
6.06 A patent or patent application licensed under this Agreement
shall cease to fall within the Licensed Patent Rights for the
purpose of computing earned royalty payments in any given
country on the earliest of the dates that a) the application has
been abandoned and not continued, b) the patent expires or
irrevocably lapses, or c) the claim has been held to be invalid
or unenforceable by an unappealed or unappealable decision of a
court of competent jurisdiction or administrative agency.
6.07 No multiple royalties shall be payable because any Licensed
Products or Licensed Processes are covered by more than one of
the Licensed Patent Rights.
6.08 On sales of Licensed Products by Licensee to sublicensees or on
sales made in other than an arm's-length transaction, the value
of the Net Sales attributed under this Article 6 to such a
transaction shall be that which would have been received in an
arm's-length transaction, based on sales of like quantity and
quality products on or about the time of such transaction.
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6.09 With regard to expenses associated with the preparation, filing,
prosecution, and maintenance of all patent applications and
patents included within the Licensed Patent Rights incurred by
PHS prior to the effective date of this Agreement, Licensee
shall pay to PHS, as an additional royalty, within sixty (60)
days of PHS's submission of a statement and request for payment
to Licensee, an amount equivalent to such patent expenses
previously incurred by PHS.
6.10 With regard to expenses associated with the preparation, filing,
prosecution, and maintenance of all patent applications and
patents included within the Licensed Patent Rights incurred by
PHS on or after the effective date of this Agreement, PHS, at
its sole option, may require Licensee:
(a) to pay PHS on an annual basis, within sixty (60) days of
PHS's submission of a statement and request for payment, a
royalty amount equivalent to all such patent expenses incurred
during the previous calendar year(s); or
(b) to pay such expenses directly to the law firm employed by
PHS to handle such functions. However, in such event, PHS and
not Licensee shall be the client of such law firm.
In limited circumstances, Licensee may be given the right to
assume responsibility for the preparation, filing, prosecution,
or maintenance of any patent application or patent included with
the Licensed Patent Rights. In that event, Licensee shall
directly pay the attorneys or agents engaged to prepare, file,
prosecute, or maintain such patent applications or patents and
shall provide to PHS copies of each invoice associated with such
services as well as documentation that such invoices have been
paid.
6.11 Licensee may elect to surrender its rights in any country of the
Licensed Territory under any Licensed Patent Rights upon ninety
(90) days written notice to PHS and owe no payment obligation
under Article 6.10 for patent-related expenses incurred in that
country after ninety (90) days of the effective date of such
written notice.
7. PATENT FILING, PROSECUTION. AND MAINTENANCE
7.01 Except as otherwise provided in this Article 7, PHS agrees to
take responsibility for, but to consult with, the Licensee in
the preparation, filing, prosecution, and maintenance of any and
all patent applications or patents included in the Licensed
Patent Rights and shall furnish copies of relevant
patent-related documents to Licensee.
7.02 Upon PHS's written request, Licensee shall assume the
responsibility for the preparation, filing, prosecution, and
maintenance of any and all patent applications or patents
included in the Licensed Patent Rights and shall on an ongoing
basis promptly furnish copies of all patent-related documents to
PHS. In such event, Licensee shall, subject to the prior
approval of PHS, select registered patent attorneys or patent
agents to provide such services on behalf of Licensee and PHS.
PHS shall provide appropriate powers of attorney and other
documents necessary to undertake such actions to the patent
attorneys or patent agents providing such services. Licensee and
its attorneys or agents shall consult with PHS in all aspects of
the preparation, filing, prosecution and maintenance of patent
applications and patents included within the Licensed Patent
Rights and shall provide PHS sufficient opportunity to comment
on any document that Licensee intends to file or to cause to be
filed with the relevant intellectual property or patent office.
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7.03 At any time, PHS may provide Licensee with written notice that
PHS wishes to assume control of the preparation, filing,
prosecution, and maintenance of any and all patent applications
or patents included in the Licensed Patent Rights. If PHS elects
to assume such responsibilities, Licensee agrees to cooperate
fully with PHS, its attorneys, and agents in the preparation,
filing, prosecution, and maintenance of any and all patent
applications or patents included in the Licensed Patent Rights
and to provide PHS with complete copies of any and all documents
or other materials that PHS deems necessary to undertake such
responsibilities. Licensee shall be responsible for all costs
associated with transferring patent prosecution responsibilities
to an attorney or agent of PHS's choice.
7.04 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
with respect to the preparation, filing, prosecution, and
maintenance of Licensed Patent Rights, which comments and
suggestions shall be considered by the other party.
8. RECORD KEEPING
8.01 Licensee agrees to keep accurate and correct records of Licensed
Products made, used, sold, or imported and Licensed Processes
practiced under this Agreement appropriate to determine the
amount of royalties due PHS. Such records shall be retained for
at least five (5) years following a given reporting period and
shall be available during normal business hours for inspection
at the expense of PHS by an accountant or other designated
auditor selected by PHS for the sole purpose of verifying
reports and payments hereunder. The accountant or auditor shall
only disclose to PHS information relating to the accuracy of
reports and payments made under this Agreement. If an inspection
shows an underreporting or underpayment in excess of five
percent (5%) for any twelve (12) month period, then Licensee
shall reimburse PHS for the cost of the inspection at the tune
Licensee pays the unreported royalties, including any late
charges as required by Paragraph 9.08 of this Agreement. All
payments required under this Paragraph shall be due within
thirty (30) days of the date PHS provides Licensee notice of the
payment due.
8.02 Licensee agrees to have an audit of sales and royalties
conducted by an independent auditor at least every two (2) years
if annual sales of the Licensed Product or Licensed Processes
are over two (2) million dollars. The audit shall address, at a
minimum, the amount of gross sales by or on behalf of Licensee
during the audit period, terms of the license as to percentage
or fixed royalty to be remitted to the Government, the amount of
royalty funds owed to the Government under this Agreement, and
whether the royalty amount owed has been paid to the Government
and is reflected in the records of the Licensee. The audit shall
also indicate the PHS license number, product, and the time
period being audited. A report certified by the auditor shall be
submitted promptly by the auditor directly to PHS on completion.
Licensee shall pay for the entire cost of the audit.
9. REPORTS ON PROGRESS, BENCHMARKS. SALES. AND PAYMENTS
9.01 Prior to signing this Agreement, Licensee has provided to PHS
the Commercial Development Plan at Appendix F, under which
Licensee intends to bring the subject matter of the Licensed
Patent Rights to the point of Practical Application. This
Commercial Development Plan is hereby incorporated by reference
into this Agreement. Based on this plan, performance Benchmarks
are determined as specified in Appendix E.
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9.02 Licensee shall provide written annual reports on its product
development progress or efforts to commercialize under the
Commercial Development Plan for each of the Licensed Fields of
Use within sixty (60) days after December 31 of each calendar
year. These progress reports shall include, but not be limited
to: progress on research and development, status of applications
for regulatory approvals, manufacturing, sublicensing,
marketing, importing, and sales during the preceding calendar
year, as well as plans for the present calendar year. PHS also
encourages these reports to include information on any of
Licensee's public service activities that relate to the Licensed
Patent Rights. If reported progress differs from that projected
in the Commercial Development Plan and Benchmarks, Licensee
shall explain the reasons for such differences. In any such
annual report, Licensee may propose amendments to the Commercial
Development Plan, acceptance of which by PHS may not be denied
unreasonably. Licensee agrees to provide any additional
information reasonably required by PHS to evaluate Licensee's
performance under this Agreement. Licensee may amend the
Benchmarks at any time upon written consent by PHS. PHS shall
not unreasonably withhold approval of any request of Licensee to
extend the time periods of this schedule if such request is
supported by a reasonable showing by Licensee of diligence in
its performance under the Commercial Development Plan and toward
bringing the Licensed Products to the point of Practical
Application as defined in 37 C.F.R. 404.3(d). Licensee shall
amend the Commercial Development Plan and Benchmarks at the
request of PHS to address any Licensed Fields of Use not
specifically addressed in the plan originally submitted.
9.03 Licensee shall report to PHS the dates for achieving Benchmarks
specified in Appendix E and the First Commercial Sale in each
country in the Licensed Territory within thirty (30) days of
such occurrences.
9.04 Licensee shall submit to PHS within sixty (60) days after each
calendar half-year ending June 30 and December 31 a royalty
report setting forth for the preceding half-year period the
amount of the Licensed Products sold or Licensed Processes
practiced by or on behalf of Licensee in each country within the
Licensed Territory, the Net Sales, and the amount of royalty
accordingly due. With each such royalty report, Licensee shall
submit payment of the earned royalties due. If no earned
royalties are due to PHS for any reporting period, the written
report shall so state. The royalty report shall be certified as
correct by an authorized officer of Licensee and shall include a
detailed listing of all deductions made under Paragraph 2.10 to
determine Net Sales made under Article 6 to determine royalties
due.
9.05 Licensee agrees to forward semi-annually to PHS a copy of such
reports received by Licensee from its sublicensees during the
preceding half-year period as shall be pertinent to a royalty
accounting to PHS by Licensee 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 New York foreign exchange rate quoted in The
Wall Street Journal on the day that the payment is due. All
checks and bank drafts shall be drawn on United States banks and
shall be payable, as appropriate, to "NIH/Patent Licensing." All
such payments shall be sent to the following address: NIH, X.X.
Xxx 000000, Xxxxxxxxxx, XX 1525 1-6 120. Any loss of exchange,
value, taxes, or other expenses incurred in the transfer or
conversion to U.S. dollars shall be paid entirely by Licensee.
The royalty report required by Paragraph 9.04 of this Agreement
shall accompany each such payment, and a copy of such report
shall also be mailed to PHS at its address for notices indicated
on the Signature Page of this Agreement.
9.07 Licensee shall be solely responsible for determining if any tax
on royalty income is owed outside the United States and shall
pay any such tax and be responsible for all filings with
appropriate agencies of foreign governments.
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9.08 Interest and penalties may be assessed by PHS on any overdue
payments in accordance with the Federal Debt Collection Act. The
payment of such late charges shall not prevent PHS from
exercising any other rights it may have as a consequence of the
lateness of any payment.
9.09 All plans and reports required by this Article 9 and marked
"confidential" by Licensee shall, to the extent permitted by
law, be treated by PHS as commercial and financial information
obtained from a person and as privileged and confidential, and
any proposed disclosure of such records by the PHS under the
Freedom of Information Act (FOIA). 5 U.S.C. Section 552 shall be
subject to the predisclosure notification requirements of 45
C.F.R. Section 5.65(d).
10. PERFORMANCE
10.01 Licensee shall use its reasonable best efforts to bring the
Licensed Products and Licensed Processes to Practical
Application. "Reasonable best efforts" for the purposes of this
provision shall include adherence to the Commercial Development
Plan at Appendix F and performance of the Benchmarks at Appendix
F. The efforts of a sublicensee shall be considered the efforts
of Licensee.
10.02 Upon the First Commercial Sale, until the expiration of this
Agreement, Licensee shall use its reasonable best efforts to
make Licensed Products and Licensed Processes reasonably
accessible to the United States public.
11. INFRINGEMENT AND PATENT ENFORCEMENT
11.01 PHS and Licensee agree to notify each other promptly of each
infringement or possible infringement of the Licensed Patent
Rights, as well as any facts which may affect the validity,
scope, or enforceability of the Licensed Patent Rights of which
either Party becomes aware.
11.02 Pursuant to this Agreement and the provisions of Chapter 29 of
title 35, United States Code, Licensee may: a) bring suit in its
own name, at its own expense, and on its own behalf for
infringement of presumably valid claims in the Licensed Patent
Rights; b) in any such suit, enjoin infringement and collect for
its use, damages, profits, and awards of whatever nature
recoverable for such infringement; and c) settle any claim or
suit for infringement of the Licensed Patent Rights provided,
however, that PHS and appropriate Government authorities shall
have the first right to take such actions. If Licensee desires
to initiate a suit for patent infringement, Licensee shall
notify PHS in writing. If PHS does not notify Licensee of its
intent to pursue legal action within ninety (90) days, Licensee
will be free to initiate suit. PHS shall have a continuing right
to intervene in such suit. Licensee shall take no action to
compel the Government either to initiate or to join in any such
suit for patent infringement. Licensee may request the
Government to initiate or join in any such suit if necessary to
avoid dismissal of the suit. Should the Government be made a
party to any such suit, Licensee shall reimburse the Government
for any costs, expenses, or fees which the Government incurs as
a result of such motion or other action, including any and all
costs incurred by the Government in opposing any such motion or
other action. In all cases, Licensee agrees to keep PHS
reasonably apprised of the status and progress of any
litigation. Before Licensee commences an infringement action,
Licensee shall notify PHS and give careful consideration to the
views of PHS and to any potential effects of the litigation on
the public health in deciding whether to bring suit.
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11.03 In the event that a declaratory judgment action alleging
invalidity or non-infringement of any of the Licensed Patent
Rights shall be brought against Licensee or raised by way of
counterclaim or affirmative defense in an infringement suit
brought by Licensee under Paragraph 11.02, pursuant to this
Agreement and the provisions of Chapter 29 of Xxxxx 00, Xxxxxx
Xxxxxx Code or other statutes, Licensee may: a) defend the suit
in its own name, at its own expense, and on its own behalf for
presumably valid claims in the Licensed Patent Rights; b) in any
such suit, ultimately to enjoin infringement and to collect for
its use, damages, profits, and awards of whatever nature
recoverable for such infringement; and c) settle any claim or
suit for declaratory judgment involving the Licensed Patent
Rights-provided, however, that PHS and appropriate Government
authorities shall have the first right to take such actions and
shall have a continuing right to intervene in such suit. If PHS
does not notify Licensee of its intent to respond to the legal
action within a reasonable time, Licensee will be free to do so.
Licensee shall take no action to compel the Government either to
initiate or to join in any such declaratory judgment action.
Licensee may request the Government to initiate or to join any
such suit if necessary to avoid dismissal of the suit. Should
the Government be made a party to any such suit by motion or any
other action of Licensee, Licensee shall reimburse the
Government for any costs, expenses, or fees which the Government
incurs as a result of such motion or other action. If Licensee
elects not to defend against such declaratory judgment action,
PHS, at its option, may do so at its own expense. In all cases,
Licensee agrees to keep PHS reasonably apprised of the status
and progress of any litigation. Before Licensee commences an
infringement action, Licensee shall notify PHS and give careful
consideration to the views of PHS and to any potential effects
of the litigation on the public health in deciding whether to
bring suit.
11.04 In any action under Paragraphs 11.02 or 11.03, the expenses
including costs, fees, attorney fees, and disbursements, shall
be paid by Licensee. The value of any recovery made by Licensee
through court judgment or settlement shall be treated as Net
Sales and subject to earned royalties.
11.05 PHS shall cooperate fully with Licensee in connection with any
action under Paragraphs 11.02 or 11.03. PHS agrees promptly to
provide access to all necessary documents and to render
reasonable assistance in response to a request by Licensee.
12. NEGATION OF WARRANTIES AND INDEMNIFICATION
12.01 PHS offers no warranties other than those specified in
Article 1.
12.02 PHS 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.
12.03 PHS 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 OR TANGIBLE MATERIALS RELATED THERETO.
12.04 PHS does not represent that it will commence legal actions
against third parties infringing the Licensed Patent Rights.
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12.05 Licensee shall indemnify and hold PHS, its employees, students,
fellows, agents, and consultants harmless from and against all
liability, demands, damages, expenses, and losses, including but
not limited to death, personal injury, illness, or property
damage in connection with or arising out of: a) the use by or on
behalf of Licensee, its sublicensees, directors, employees, or
third parties of any Licensed Patent Rights; or b) the design,
manufacture, distribution, or use of any Licensed Products,
Licensed Processes or materials by Licensee, or other products
or processes developed in connection with or arising out of the
Licensed Patent Rights. Licensee agrees to maintain a liability
insurance program consistent with sound business practice.
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 Licensee is in default in the performance of
any material obligations under this Agreement, including but not
limited to the obligations listed in Article 13.05, and if the
default has not been remedied within ninety (90) days after the
date of notice in writing of such default, PHS may terminate
this Agreement by written notice and pursue outstanding amounts
owed through procedures provided by the Federal Debt Collection
Act.
13.03 In the event that Licensee becomes insolvent, files a petition
in bankruptcy, 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,
Licensee shall immediately notify PHS in writing. Furthermore,
PHS shall have the right to terminate this Agreement immediately
upon Licensee's receipt of written notice.
13.04 Licensee shall have a unilateral right to terminate this
Agreement and/or any licenses in any country or territory by
giving PHS sixty (60) days written notice to that effect.
13.05 PHS shall specifically have the right to terminate or modify, at
its option, this Agreement, if PHS determines that the Licensee:
1) is not executing the Commercial Development Plan submitted
with its request for a license and the Licensee cannot otherwise
demonstrate to PHS's satisfaction that the Licensee 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; 2) has not achieved the Benchmarks as may
be modified under Paragraph 9.02; 3) 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; 4) has committed a material breach of a covenant or
agreement contained in the license; 5) is not keeping Licensed
Products or Licensed Processes reasonably available to the
public after commercial use commences; 6) cannot reasonably
satisfy unmet health and safety needs; or 7) cannot reasonably
justify a failure to comply with the domestic production
requirement of Paragraph 5.02 unless waived. In making this
determination, PHS 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 Licensee under Paragraph 9.02. Prior to
invoking this right, PHS shall give written notice to Licensee
providing Licensee specific notice of, and a ninety (90) day
opportunity to respond to, PHS's concerns as to the previous
items 1) to 7). If Licensee fails to alleviate PHS's concerns as
to the previous items 1) to 7) or fails to initiate corrective
action to PHS's satisfaction, PHS may terminate this Agreement.
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13.06 When the public health and safety so require, and after written
notice to Licensee providing Licensee a sixty (60) day
opportunity to respond, P1-IS shall have the right to require
Licensee to grant sublicenses to responsible applicants, on
reasonable terms, in any Licensed Fields of Use under the
Licensed Patent Rights, unless Licensee 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. PHS will not
require the granting of a sublicense unless the responsible
applicant has first negotiated in good faith with Licensee.
13.07 PHS reserves the right according to 35 U.S.C. Section 209(0(4)
to terminate or modify this Agreement if it is determined that
such action is necessary to meet requirements for public use
specified by federal regulations issued after the date of the
license and such requirements are not reasonably satisfied by
Licensee.
13.08 Within thirty (30) days of receipt of written notice of PHS's
unilateral decision to modify or terminate this Agreement,
Licensee may, consistent with the provisions of 37 C.F.R.
404.11, appeal the decision by written submission to the
designated PHS official. The decision of the designated PHS
official shall be the final agency decision. Licensee may
thereafter exercise any and all administrative or judicial
remedies that may be available.
13.09 Within ninety (90) days of expiration or termination of this
Agreement under this Article 13, a final report shall be
submitted by Licensee. Any royalty payments, including those
incurred but not yet paid (such as the full minimum annual
royalty), and those related to patent expense, due to PHS 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
PHS pursuant to Paragraph 4.03. Unless otherwise specifically
provided for under this Agreement, upon termination or
expiration of this Agreement, Licensee shall return all Licensed
Products or other materials included within the Licensed Patent
Rights to PHS or provide PHS with certification of the
destruction thereof.
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
the Government 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 the Government or
excuse a similar subsequent failure to perform any such term or
condition by Licensee.
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.
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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 District of Columbia.
14.06 All notices required or permitted by this Agreement shall be
given by prepaid, first class, registered or certified mail or
by an express/overnight delivery service provided by a
commercial carrier, 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
Xxxxx. Notices shall be considered timely if such notices are
received on or before the established deadline date or sent on
or before the deadline date as verifiable by U.S. Postal Service
postmark or dated receipt from a commercial carrier. Parties
should request a legibly dated U.S. Postal Service postmark or
obtain a dated receipt from a commercial carrier or the U.S.
Postal Service. Private metered postmarks shall not be
acceptable as proof of timely mailing.
14.07 This Agreement shall not be assigned by Licensee except: a) with
the prior written consent of PHS, such consent not to be
withheld unreasonably; or b) as part of a sale or transfer of
substantially the entire business of Licensee relating to
operations which concern this Agreement. Licensee shall notify
PHS within ten (10) days of any assignment of this Agreement by
Licensee, and Licensee shall pay PHS, as an additional royalty,
[ * ] of the fair market value of any consideration received for
any assignment of this Agreement within thirty (30) days of such
assignment.
14.08 Licensee agrees in its use of any PHS-supplied materials to
comply with all applicable statutes, regulations, and
guidelines, including PHS and DHHS regulations and guidelines.
Licensee agrees not to use the materials for research involving
human subjects or clinical trials in the United States without
complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46. Licensee
agrees not to use the materials for research involving human
subjects or clinical trials outside of the United States without
notifying PHS, in writing, of such research or trials and
complying with the applicable regulations of the appropriate
national control authorities. Written notification to PHS of
research involving human subjects or clinical trials outside of
the United States shall be given no later than sixty (60) days
prior to commencement of such research or trials.
14.09 Licensee 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 Licensee that it shall not export such items to
certain foreign countries without prior approval of such agency.
PHS neither represents that a license is or is not required or
that, if required, it shall be issued.
14.10 Licensee agrees to xxxx the Licensed Products or their packaging
sold in the United States with all applicable U.S. patent
numbers and similarly to indicate "Patent Pending" status. All
Licensed Products manufactured in, shipped to, or sold in other
countries shall be marked in such a manner as to preserve PHS
patent rights in such countries.
14.11 By entering into this Agreement, PHS does not directly or
indirectly endorse any product or service provided, or to be
provided, by Licensee whether directly or indirectly related to
this Agreement. Licensee shall not state or imply that this
Agreement is an endorsement by the Government, PHS, any other
Government organizational unit, or any Government employee.
Additionally, Licensee shall not use the names of NIH, CDC, PHS,
or DHHS or the Government or their employees in any advertising,
promotional, or sales literature without the prior written
consent of PHS.
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
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14.12 The Parties agree to attempt to settle amicably any controversy
or claim arising under this Agreement or a breach of this
Agreement, except for appeals of modifications or termination
decisions provided for in Article 13. Licensee agrees first to
appeal any such unsettled claims or controversies to the
designated PHS official, or designee, whose decision shall be
considered the final agency decision. Thereafter, Licensee may
exercise any administrative or judicial remedies that may be
available.
14.13 Nothing relating to the grant of a license, nor the grant
itself, shall be construed to confer upon any person any
immunity from or defenses under the antitrust laws or from a
charge of patent misuse, and the acquisition and use of rights
pursuant to 37 C.F.R. Part 404 shall not be immunized from the
operation of state or Federal law by reason of the source of the
grant.
14.14 Paragraphs 4.03, 8.01, 9.05-9.07, 12.01-12.05, 13.08, 13.09, and
14.12 of this Agreement shall survive termination of this
Agreement.
SIGNATURES BEGIN ON NEXT PAGE
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17
PHS PATENT LICENSE AGREEMENT--EXCLUSIVE
SIGNATURE PAGE
For PHS:
/s/ Xxxx Xxxxxxx 2/5/01
------------------------------------------------ --------------------------
Xxxx Xxxxxxx, Ph.D. Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health
Mailing Address for Notices:
Office of Technology Transfer
National Institutes of Health
0000 Xxxxxxxxx
Xxxxxxxxx, Xxxxx 000
Xxxxxxxxx, Xxxxxxxx 00000-0000 X.X.X.
For LICENSEE (Upon, information and belief, the undersigned expressly certifies
or affirms that the contents of any statements of LICENSEE made or referred to
in this document are truthful and accurate.):
by:
/s/ Xxxxx X. Xxxxxxxxx 2/6/01
----------------------------------------------------- --------------------------
Signature of Authorized Official
Xxxxx X. Xxxxxxxxx
-----------------------------------------------------
Printed Name
President & CEO
-----------------------------------------------------
Title
Official and Mailing Address for Notices:
RegeneRx Biopharmaceuticals Inc.
0 Xxxxxxxx Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Attention: XX Xxxxxxxxxxx
Any false or misleading statements made, presented, or submitted to the
GOVERNMENT, including any relevant omissions, under this AGREEMENT and during
the course of negotiation of this AGREEMENT are subject to all applicable civil
and criminal statutes including Federal statutes 31 U.S.C. Sections 3801-3812
(civil liability) and 18 U.S.C. Section 1001 (criminal liability including
fine(s) and/or imprisonment).
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APPENDIX A--Patent(s) or Patent Application(s)
Patent(s) or Patent Application(s):
(A) PCT/US99/l7282 (PHS Ref. E-13 1-98/1) entitled "Thymosin a4
Promotes Wound Repair" filed July 29, 1999 which claims the
benefit of U.S. Provisional Application USSN 60/094,690 (PHS
Ref. F- 131-98/0) entitled "Thymosin a4 Promotes Wound Repair"
filed July 30, 1998, now abandoned.
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APPENDIX B--Licensed Fields of Use and Territory
Licensed Fields of Use:
Development of therapeutic applications, including compositions and
methods, to be used in the treatment of wounds and tissue repair.
Licensed Territory:
Worldwide
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APPENDIX C--Royalties
Royalties:
1. Licensee agrees to pay to PHS a nonrefundable license issue royalty
pursuant to Paragraph 6.01 of this Agreement in the amount of [ * ].
II. Licensee agrees to pay to PHS a nonrefundable minimum annual royalty
pursuant to Paragraph 6.02 of this Agreement in the amount of [ * ]
until the first United States Patent, within the Licensed Patent Rights
as defined in Paragraph 2.06 of this Agreement, issues ("Pre-issuance
Minimum Annual Royalty") and in the amount of [ * ] after the issuance
of the first United States Patent within the Licensed Patent Rights as
defined in Paragraph 2.06 of this Agreement ("Post-issuance Minimum
Annual Royalty").
III. Licensee agrees to pay PHS earned royalties on Net Sales by or on behalf
of Licensee and its sublicensees pursuant to Paragraph 6.03 of this
Agreement as follows:
A. [ * ] of Net Sales
The obligation to pay PHS earned royalties on Net Sales by or on behalf
of Licensee and its sublicensees pursuant to Paragraph 6.03 of this
Agreement begins with the First Commercial Sale by or on behalf of
Licensee and its sublicensees and requires only that manufacture, use,
offer for sale, sale, or importation of the Licensed Product or the
Licensed Process involve a claim in any pending application or issued
patent within the Licensed Patent Rights. In the event that no patent
application within the Licensed Patent Rights is pending in any country
the obligation to pay PHS earned royalties under Paragraph 6.03 of this
Agreement requires that the manufacture, use, offer for sale, sale, or
importation of the Licensed Product or the Licensed Process involve a
claim of an issued patent within the Licensed Patent Rights. In the
event that the manufacture, use, offer for sale, sale, or importation of
the Licensed Product or the Licensed Process does not involve a claim of
any pending patent application or issued patent within the Licensed
Patent Rights then Licensee and its sublicensees are not obligated to
pay earned royalties under Paragraph 6.03 of this Agreement.
IV. Licensee agrees to pay PHS benchmark royalties pursuant to Paragraph
6.04 of this Agreement as follows:
A. [ * ] upon receipt of marketing approval by the United States
Food and Drug Administration.
B. [ * ] upon receipt of marketing approval from the applicable
regulatory agency in each of the following countries: Canada,
China, France, Germany, Italy, Japan, Mexico, Spain, Taiwan and
the United Kingdom.
C. [ * ] upon receipt of marketing approval from the applicable
regulatory agency of any other country for which patent
protection has been received in such country for the Licensed
Patent Rights.
V. Licensee agrees to pay PHS additional sublicensing royalties pursuant to
Paragraph 6.05 of this Agreement as follows:
[ * ] of the fair market value of any consideration received for
granting each sublicense.
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
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APPENDIX D--Modifications
PHS and Licensee agree to the following modifications to the Articles and
Paragraphs of this Agreement:
Article I. BACKGROUND
Paragraphs 1.01 through 1.02 are amended to read as follows:
1.01 In the course of conducting biomedical and behavioral research,
PHS investigators and others have made inventions that may have
commercial applicability.
1.02 By assignment of rights from PHS employees and other inventors,
DHHS, on behalf of the United States Government, owns certain
interests in intellectual property rights claimed in certain
United States and foreign patent applications or patents
corresponding to the assigned inventions. DHHS also owns any
tangible embodiments of these inventions actually reduced to
practice by PHS, to the extent of PHS's interest therein.
New Paragraph 1.06 is added to read as follows:
1.06 Xxxxx X. Xxxxxxxxx, who, along with PHS developed the inventions
which are the subject of this Agreement, has assigned all of his
rights in and to such inventions to Licensee, and, therefore,
Licensee is the owner of an undivided and equal interest in and
to such inventions and may practice such inventions without the
benefit of this Agreement. By this Agreement, however, PHS and
Licensee intend for Licensee to have the exclusive right to
practice such inventions within the Fields of Use as specified
in Appendix B of this Agreement.
Article 2. DEFINITIONS
Paragraphs 2.01 through 2.03, 2.06 and 2.12 are amended to read as follows:
2.01 "Benchmarks" mean the performance milestones that are set forth
in Appendix F, as may be amended from time to time by the mutual
written consent of PHS and Licensee.
2.02 "Commercial Development Plan" means the written
commercialization plan attached as Appendix F, as may be amended
from time to time by the mutual written consent of PHS and
Licensee.
2.03 "First Commercial Sale" means the initial transfer by or on
behalf of Licensee or its sublicensees of Licensed Products or
the initial practice of a Licensed Process by or on behalf of
Licensee or its sublicensees in exchange for cash or some
equivalent to which value can be assigned for the purpose of
determining Net Sales, provided, however, First Commercial Sale
shall not include transfers at or below cost by or on behalf of
Licensee, its Affiliates, or its sublicensees of Licensed
Products or the practice of Licensed Processes in connection
with compassionate use, emergency use, treatment Investigational
New Drug Applications (IND's), or the like authorized by the FDA
or corresponding foreign agencies.
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2.06 "Licensed Patent Rights" shall mean:
a) Patent applications (including provisional patent
applications and PCT patent applications) and/or patents
listed in Appendix A, all divisions and continuations of
these applications, all patents issuing from such
applications, divisions, and continuations, and any
reissues, reexaminations, reregistrations, and
extensions of all such patents;
b) to the extent that the following contain one or more
claims directed to the invention or inventions disclosed
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; iv) priority patent application(s) of a)
above; and v) any reissues, reexaminations,
reregistrations, and extensions of all such patents;
c) to the extent that the following contain one or more
claims directed to the invention or inventions disclosed
in a) above: all counterpart foreign and U.S. patent
applications and patents to a) and b) above, including
those listed in Appendix A.
Licensed Patent Rights shall not include b) or c) above to the
extent that they contain one or more claims directed to new
matter which is not the subject matter disclosed in a) above.
2.12 "Research License" means a nontransferable, nonexclusive license
to make and to use the Licensed Products or Licensed Processes
as defined by the Licensed Patent Rights solely for purposes of
research and not for purposes of commercial manufacture or
distribution or in lieu of purchase.
New Paragraphs 2.13 through 2.15 are added to the Agreement and read as follows:
2.13 "FDA" means the U.S. Food and Drug Administration.
2.14 "Affiliate(s)" means any corporation or other business entity
controlling, controlled by, or under common control with
Licensee. For this purpose, "control" means direct or indirect
beneficial ownership of at least fifty percent (50%) interest in
the income of such corporation or other business.
2.15 "Combined Product" means a product that contains a Licensed
Product along with at least one other active component or active
ingredient not covered by the Licensed Patent Rights.
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23
Article 3. GRANT OF RIGHTS
Paragraphs 3.01 and 3.02 are amended to read as follows:
3.01 PHS hereby grants to Licensee and its Affiliate(s) and Licensee
and its Affiliate(s) accept, subject to the terms and conditions
of this Agreement, an exclusive license under the Licensed
Patent Rights in the Licensed Territory to make and have made,
to use and have used, to sell and have, sold, to offer to sell,
and to import any Licensed Products in the Licensed Fields of
Use and to practice and have practiced any Licensed Processes in
the Licensed Fields of Use. Licensee shall notify PHS, in
writing, of any Affiliate included under this Paragraph 3.01,
and for the purposes of this Agreement, the term Licensee shall
include such Affiliate
3.02 This Agreement confers no license or rights by implication,
estoppel, or otherwise to either party under any patent
applications or patents (or rights therein) of PHS or of
Licensee other than Licensed Patent Rights regardless of whether
such patents are dominant or subordinate to Licensed Patent
Rights.
New Paragraphs 3.03 through 3.05 are added to the Agreement and read as follows:
3.03 PHS grants Licensee the benefit of any patent term extensions
and reregistrations applicable to the Licensed Patent Rights
and, as long as Licensed Patent Rights are in existence, the
benefit of any Orphan Drug Act registrations applicable to
Licensed Products and Licensed Processes and comparable
extensions and registrations in foreign countries within the
Licensed Territory. PHS agrees to submit applications to
appropriate governmental agencies at the request and expense of
Licensee or to otherwise cooperate, at Licensee's expense, in
connection with applying for and obtaining such extensions and
registrations.
3.04 This Agreement provides no rights to PHS to utilize rights to
Licensee's solely owned intellectual property, know-how, data or
regulatory submissions or to disseminate such information to
third parties, except with Licensee's consent or as otherwise
required by law.
3.05 Notwithstanding the grant set forth in Paragraph 3.01 herein, or
any other provisions of this Agreement, in the event that a
third party submits a bona fide Application to License PHS
Inventions to PHS requesting a Non-Exclusive license to an
indication within the Licensed Field of Use as defined in
Paragraph 2.05, Licensee will have a period of ninety (90) days
from the date which Licensee is notified in writing by PHS of
the third party's application for a Non-Exclusive license to
submit to PHS an acceptable detailed, written Commercial
Development Plan and Benchmarks for the indication for which
third party has applied for a Non-Exclusive license. In the
event that Licensee fails to submit to PHS the Commercial
Development Plan and Benchmarks for the indication requested by
the third party by the end of the ninety (90) day period
specified in this Paragraph 3.05 such failure will result in the
grant pursuant to Paragraph 3.01 becoming Non-Exclusive for the
indication for which the third party has requested a
Non-Exclusive License.
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24
Article 4. SUBLICENSING
Paragraph 4.03 is amended to read as follows:
4.03 Any sublicenses granted by Licensee shall provide for the
termination of the sublicense, or the conversion to a license
directly between such sublicensees, on the one hand, and PHS and
Licensee, on the other hand, at the option of the sublicensee,
upon termination of this Agreement under Article 13. Any
sublicense granted by Licensee shall further provide for the
termination of the sublicense or the conversion to a license
directly between such sublicensee, on the one hand, and PHS and
Licensee, on the other hand at the option of the sublicensee, if
PHS rescinds a Licensed Field of Use to Licensee and said
Licensed Field of Use was granted by the Licensee in said
sublicense. A conversion, in either of such cases, is subject to
PHS approval, which shall not be unreasonably withheld, and is
contingent upon acceptance by the sublicensee of the remaining
provisions of this Agreement.
Article 5. STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
Paragraphs 5.01, 5.03, and 5.04 are amended to read as follows:
5.01 PHS reserves on behalf of the Government an irrevocable,
nonexclusive, nontransferable, royalty-free license for the
practice of all inventions licensed under the 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. Prior to the
First Commercial Sale, Licensee agrees to provide PHS reasonable
quantities of Licensed Products or materials made through the
Licensed Processes solely for PHS research use and not for
purposes of commercial development, manufacture or distribution,
at a price equal to Licensee's cost of such.
5.03 Licensee acknowledges that PHS may enter into future Cooperative
Research and Development Agreements (CRADAs) under the Federal
Technology Transfer Act of 1986 that relate to the subject
matter of this Agreement. PHS agrees to notify Licensee, as soon
as is practical of any proposed CRADA that relates to the
subject matter of this Agreement. Licensee agrees not to
unreasonably deny requests for a Research License from such
future collaborators with PHS when acquiring such rights is
necessary in order to make a Cooperative Research and
Development Agreement (CRADA) project feasible. As of the
effective date of this Agreement, Licensee requests that
Licensee have an opportunity to join as a party to any proposed
Cooperative Research and Development Agreement (CRADA).
5.04 In addition to the reserved license of Paragraph 5.01 above, PHS
reserves the right to grant such nonexclusive Research Licenses
directly or to require Licensee to grant nonexclusive Research
Licenses on commercially reasonable terms. The purpose of this
Research License is to encourage basic research, whether
conducted at an academic or corporate facility. In order to
safeguard the Licensed Patent Rights, however, PHS shall consult
with Licensee before granting to commercial entities a Research
License or providing to them research samples of Licensed
Products or materials made through the Licensed Processes,
provided however that PHS will not provide materials obtained
from Licensee under Paragraph 5.01 above to third parties,
except with Licensee's prior written consent, which shall not be
unreasonably withheld.
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25
Article 6. ROYALTIES AND REIMBURSEMENT
Paragraphs 6.01, 6.02, 6.04, 6.06, and 6.08 through 6.10 are amended to read as
follows:
6.01 Licensee agrees to pay to PHS a nonrefundable license issue
royalty as set forth in Appendix C within thirty (30) days from
the date that this Agreement becomes effective, in part to
reimburse PHS for the preparation, filing, prosecution, and
maintenance of all patent applications and patents included
within the Licensed Patent Rights incurred by PHS prior to the
effective date of this Agreement. Within sixty (60) days of the
effective date of this Agreement, PHS shall submit to Licensee a
detailed statement of such patent expenses previously incurred
by PHS.
6.02 Licensee agrees to pay to PHS a nonrefundable minimum annual
royalty as set forth in Appendix C. The minimum annual royalty
is due and payable on January 1 of each calendar year and may be
credited against any earned royalties due for sales made in that
year. The minimum annual royalty due for the first calendar year
of this Agreement may be prorated according to the fraction of
the calendar year remaining between the effective date of this
Agreement and the next subsequent January 1, and shall be due
upon the effective date of this Agreement and payable within
sixty (60) days after the date that this Agreement becomes
effective. In the event that the first United States Patent
issues after the payment of the minimum annual royalty for the
year in which the first United States Patent issues, the first
payment of the Post-issuance Minimum Annual Royalty will be due
beginning the January 1 subsequent to the issuance of the
patent. In the event that the minimum annual royalty, for any
year, exceeds the earned royalty payable under Paragraph 6.03
for that same year, the excess minimum annual royalty may be
carried as a credit against the earned royalties for succeeding
periods until used in full.
6.04 Licensee agrees to pay PHS benchmark royalties as set forth in
Appendix C. The benchmark royalties payable under this Paragraph
may be credited against any earned royalties due for sales made
in the year the benchmark royalty is payable. In the event that
the benchmark royalty, for any year, exceeds the earned royalty
payable under Paragraph 6.03 for that same year, the excess
benchmark royalty may be carried as a credit against the earned
royalties for succeeding periods until used in full.
6.06 A claim of a patent or patent application licensed under this
Agreement shall cease to fall within the Licensed Patent Rights
for the purpose of computing earned royalty payments in any
given country in the Licensed Territory on the earliest of the
dates that a) the claim has been abandoned and not continued, b)
the patent expires or irrevocably lapses, or c) the claim has
been held to be invalid or unenforceable by an unappealed or
unappealable decision of a court of competent jurisdiction or
administrative agency.
6.08 On sales of Licensed Products by Licensee to sublicensees or
Affiliates, other than sales of Licensed Products intended for
resale, or on sales made in other than an arm's-length
transaction, the value of the Net Sales attributed under this
Article 6 to such a transaction shall be that which would have
been received in an arm's-length transaction, based on sales of
like quantity and quality products on or about the time of such
transaction. On sales of Licensed Products by Licensee to
sublicensees or Affiliates which are intended for resale,
royalties shall be calculated on the basis of Net Sales of
Licensed Products by any such sublicensee or Affiliate to
someone other than an Affiliate as provided in Paragraph 6.03
hereof.
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6.09 With regard to expenses associated with the preparation, filing,
prosecution, and maintenance of all patent applications and
patents included within the Licensed Patent Rights incurred by
PHS prior to the effective date of this Agreement, and to the
extent that such expenses exceed the License Issue Royalty as
set forth in Paragraph 6.01 of this Agreement, Licensee shall
pay to PHS, as an additional royalty, within sixty (60) days of
PHS's submission of a statement and request for payment to
Licensee, an amount equivalent to the difference between the
License Issue Royalty as set forth in Paragraph 6.01 of this
Agreement and the total of such patent expenses previously
incurred by PHS.
6.10 With regard to expenses associated with the preparation, filing,
prosecution, and maintenance of all patent applications and
patents included within the Licensed Patent Rights incurred by
PHS on or after the effective date of this Agreement, PHS, at
its sole option, may require Licensee:
(a) to pay PHS on an annual basis, within sixty (60)
days of PHS's submission of a statement and request for
payment, a royalty amount equivalent to all such patent
expenses incurred during the previous calendar year(s);
or
(b) to pay such expenses directly to the law firm
employed by PHS to handle such functions within thirty
(30) days of Licensee's receipt of such law firm's
submission and a statement and request for payment.
However, in such event, PHS and not Licensee shall be
the client of such law firm.
Under exceptional circumstances, Licensee may be given the right
to assume responsibility for the preparation, filing,
prosecution, or maintenance of any patent application or patent
included with the Licensed Patent Rights. In that event,
Licensee shall directly pay the attorneys or agents engaged to
prepare, file, prosecute, or maintain such patent applications
or patents and shall provide to PHS copies of each invoice
associated with such services as well as documentation that such
invoices have been paid. Any right not assumed by Licensee under
this Paragraph 6.09 shall be performed by PHS in accordance with
Article 7.
New Paragraph 6.12 is added to this Agreement and reads as follows:
6.12 If the Licensee, its sublicensee(s) or Affiliate(s) sells a
Combined Product, the Net Sales for purposes of earned royalty
determination under this Article 6 shall be calculated by
multiplying the Net Sales of the Combined Product by the
fraction a/(ai-b), where a is the total market price of the
Licensed Product if sold separately and b is the total market
price of any other product or component in the Combined Product
if sold separately. If the Licensed Product is not sold
separately, then, for purposes of this Paragraph 6.11, the
market price of such component or product shall be determined by
assuming a market price at which such component or product
reasonably could be sold as a separate item. Notwithstanding the
foregoing, in no event should the royalty on Net Sales due and
payable to PHS under this Paragraph be reduced to an amount
equivalent to an earned royalty due under Paragraph 6.03 of
[ *] or the Minimum Annual Royalty due under Paragraph 6.02
whichever is less.
The remainder of this page intentionally left blank
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
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Article 7. PATENT FILING. PROSECUTION AND MAINTENANCE
Paragraphs 7.01 through 7.03 are amended to read as follows:
7.01 Except as otherwise provided in Article 6 or in this Article 7,
PHS agrees to take responsibility for, but to consult with, the
Licensee in the preparation, filing, prosecution, and
maintenance of any and all patent applications or patents
included in the Licensed Patent Rights and shall furnish copies
of relevant patent-related documents to Licensee or PHS shall
instruct its patent representative to provide said copies
directly to Licensee. At Licensee's request and expense, PHS
shall cooperate with Licensee in preparing, filing, prosecuting,
and maintaining such patent applications and patents included in
the Licensed Patent Rights as reasonably requested by Licensee
from time to time. Notwithstanding the foregoing, PHS will
retain principal power of attorney and primary control over the
preparation, filing, prosecution and maintenance of said patent
applications and patents. PHS shall provide Licensee with
reasonable opportunity to comment on any document PHS intends to
file or causes to be filed with the relevant patent office.
7.02 Upon PHS's written request, or at Licensee's option, Licensee
shall assume the responsibility for the preparation, filing,
prosecution, and maintenance of any and all patent applications
or patents included in the Licensed Patent Rights and shall, on
an ongoing basis, promptly furnish copies of all relevant
patent-related documents to PHS. In such event, Licensee shall,
subject to the prior approval of PHS, select registered patent
attorneys or patent agents to provide such services on behalf of
Licensee and PHS. PHS shall provide appropriate powers of
attorney and other documents necessary to undertake such actions
to the patent attorneys or patent agents providing such
services, and PHS shall otherwise cooperate fully with Licensee,
its attorneys and agents in the preparation, filing,
prosecution, and maintenance of any and all patent applications
or patents included in the Licensed Patent Rights and shall
provide Licensee with complete copies of any and all documents
or other materials that Licensee deems necessary to undertake
such responsibilities. Licensee and its attorneys or agents
shall consult with PHS in all aspects of the preparation,
filing, prosecution and maintenance of patent applications and
patents included within the Licensed Patent Rights and shall
provide PHS sufficient opportunity to comment on any document
that Licensee intends to file or to cause to be filed with the
relevant intellectual property or patent office.
7.03 At any time, following Licensee's assumption of the
responsibility for patent matters at PHS's request in accordance
with Paragraph 7.02, PHS may provide Licensee with written
notice that PHS wishes to assume control of the preparation,
filing, prosecution, and maintenance of any and all patent
applications or patents included in the Licensed Patent Rights.
If PHS elects to assume such responsibilities, Licensee agrees
to cooperate fully with PHS, its attorneys, and agents in the
preparation, filing, prosecution, and maintenance of any and all
patent applications or patents included in the Licensed Patent
Rights and to provide PHS with complete copies of any and all
documents or other materials that PHS deems necessary to
undertake such responsibilities. Licensee shall be responsible
for all costs associated with transferring patent prosecution
responsibilities to an attorney or agent of PHS's choice,
provided, however, that if PHS elects to assume control of the
preparation, filing, prosecution and maintenance of any and all
patent applications or patents included in the Licensed Patent
Rights for a reason other than Licensee's failure to perform
under this Agreement, then PHS shall be responsible for all
costs associated with transferring patent prosecution
responsibilities to an attorney or agent of PHS's choice.
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Article 8. RECORD KEEPING
Paragraph 8.01 is amended to read as follows:
8.01 Licensee agrees to keep accurate and correct records of Licensed
Products made, used, sold, or imported and Licensed Processes
practiced under this Agreement appropriate to determine the
amount of royalties due PHS. Such records shall be retained for
at least five (5) years following a given reporting period and
shall be available during normal business hours upon five (5)
business days prior written notice from PHS to Licensee for
inspection at the expense of PHS by an accountant or other
designated auditor selected by PHS for the sole purpose of
verifying reports and payments hereunder. The accountant or
auditor shall only disclose to PHS information relating to the
accuracy of reports and payments made under this Agreement. If
an inspection shows an under reporting or underpayment in excess
of five percent (5%) for any twelve (12) month period, then
Licensee shall reimburse PHS for the cost of the inspection at
the time Licensee pays the unreported royalties, including any
late charges as required by Paragraph 9.08 of this Agreement.
All payments required under this Paragraph shall be due within
thirty (30) days of the date PHS provides Licensee notice of the
payment due.
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29
Article 9. REPORTS ON PROGRESS. BENCHMARKS. SALES AND PAYMENTS
Paragraphs 9.02, 9.04, and 9.06 are amended to read as follows:
9.02 Licensee shall provide written annual reports on its product
development progress or efforts to commercialize under the
Commercial Development Plan for each of the Licensed Fields of
Use within sixty (60) days after December 31 of each calendar
year. These progress reports shall include, but not be limited
to: progress on research and development, status of applications
for regulatory approvals, manufacturing, sublicensing,
marketing, importing, and sales during the preceding calendar
year, as well as plans for the present calendar year. PHS also
encourages these reports to include information on any of
Licensee's public service activities that relate to the Licensed
Patent Rights. If reported progress differs from that projected
in the Commercial Development Plan and Benchmarks, Licensee
shall explain the reasons for such differences. To the extent
such differences are not the result of Licensee's failure to
perform in accordance with the requirements of Paragraph 10.01
hereunder, Licensee and PHS shall amend the Commercial
Development Plan and Benchmarks accordingly. The parties
recognize and acknowledge that the Commercial Development Plan
and Benchmarks represent an estimate of the time frames and
steps necessary for development of the Licensed Product(s). As
the profiles of the Licensed Product(s) and the Licensed
Process(es) become more fully understood by the parties hereto,
including without limitation, the emerging
pharmacologic/toxicologic profile in human subjects and
technical issues relating to the manufacture of Licensed
Product(s), adjustments and modifications to the Commercial
Development Plan and Benchmarks may be necessary. In addition,
preclinical and clinical work in addition to that noted in the
Commercial Development Plan may be reasonable or necessary in
order to satisfy the FDA or other regulatory requirements,
requests, or concerns regarding the Licensed Product(s) or
Licensed Process(es). Accordingly, in any such annual report,
Licensee may propose amendments to the Commercial Development
Plan and/or the Benchmarks, acceptance of which by PHS may not
be denied unreasonably. Licensee agrees to provide any
additional information reasonably required by PHS to evaluate
Licensee's performance under this Agreement. Licensee may amend
the Benchmarks at any time upon written consent by PHS. PHS
shall not unreasonably withhold approval of any request of
Licensee to extend the time periods of this schedule if such
request is supported by a reasonable showing by Licensee of
diligence in its performance under the Commercial Development
Plan and toward bringing the Licensed Products to the point of
Practical Application as defined in 37 C.F.R. 404.3(d). Licensee
shall amend the Commercial Development Plan and Benchmarks at
the request of PHS to address any Licensed Fields of Use not
specifically addressed in the plan originally submitted.
9.04 Licensee shall submit to PHS within sixty (60) days after each
calendar half-year ending June 30 and December 31 a royalty
report setting forth for the preceding half-year period the
amount of the Licensed Products sold or Licensed Processes
practiced by or on behalf of Licensee in each country within the
Licensed Territory, the Net Sales, and the amount of royalty
accordingly due. With each such royalty report, Licensee shall
submit payment of the earned royalties due. If no earned
royalties are due to PHS for any reporting period, the written
report shall so state. The royalty report shall be certified as
correct by an authorized officer of Licensee and shall include a
detailed listing of all deductions made under Paragraph 2.10 to
determine Net Sales and the calculations made under Article 6 to
determine royalties due.
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 New York foreign exchange rate quoted in The
Wall Street Journal on the day prior to the day that the payment
is due. All checks and bank drafts shall be drawn on United
States banks and shall be payable, as appropriate, to
"NIH/Patent Licensing." All such payments shall be sent to the
following
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30
address: NIH, X.X. Xxx 000000, Xxxxxxxxxx, XX 00000-0000. Any
loss of exchange, value, taxes, or other expenses incurred in
the transfer or conversion to U.S. dollars shall be paid
entirely by Licensee. The royalty report required by Paragraph
9.04 of this Agreement shall accompany each such payment, and a
copy of such report shall also be mailed to PHS at its address
for notices indicated on the Signature Page of this Agreement.
Article 10. PERFORMANCE
Paragraph 10.01 is amended to read as follows:
10.01 Licensee shall use its reasonable best efforts to bring the
Licensed Products and Licensed Processes to Practical
Application. "Reasonable best efforts" for the purposes of this
provision shall include substantial adherence to the Commercial
Development Plan at Appendix F and substantial performance of
the Benchmarks at Appendix E as may be amended from time to time
by mutual written consent. The efforts of sublicensees and
Affiliates shall be considered the efforts of Licensee. To the
extent that the Benchmarks or development obligations set forth
in Appendix E differ from or conflict with those set forth in
the Commercial Development Plan in Appendix F, Appendix E shall
be considered to supersede Appendix F and the Commercial
Development Plan in Appendix F shall be amended to be consistent
with Appendix E.
New Paragraph 10.03 is added to this Agreement and reads as follows:
10.03 In the event that an investigator is conducting clinical trials
related to the Licensed Products and/or Licensed Processes and
that clinical trial is sponsored or funded by PHS under a grant
or contract from PHS and Licensee enters into a separate
agreement with the investigator or the investigator's
Institution to provide Licensee with preclinical and/or clinical
data, including but not limited to, Investigational New Drug
Applications (IND's), Safety Reports for Serious and Unexpected
Adverse Events as defined in 37 C.F.R. Section 312.32(a)
submitted to the FDA, and IND Annual Reports submitted to the
FDA, relating to the Licensed Products and Licensed Processes
from said clinical trial sponsored or funded by PHS under a
grant or contract from PHS, Licensee agrees to provide, at
Licensee's cost of such, to said investigators conducting
clinical trials sponsored or funded by PHS under grant or
contract from PHS, sufficient quantities of Licensed Products in
a form suitable for conducting said clinical trial to complete
the aforesaid clinical trial carried out under said PHS grant or
contract.
Article 11: INFRINGEMENT AND PATENT ENFORCEMENT
Paragraph 11.04 is amended to read as follows:
11.04 In any action under Paragraphs 11.02 or 11.03, the expenses
including costs, fees, attorney fees, and disbursements
("Licensee's Expenses"), shall be paid by Licensee. The value of
any recovery, including, royalties, attorney fees, costs, fees,
and disbursements ("Recovery"), less Licensee's Expenses,
actually received by Licensee through court judgment,
arbitration, or settlement shall be treated as Net Sales and
subject to earned royalties. The payment due to PHS under this
Paragraph can also be described in the following manner:
Amount due to PHS = [ * ] * (Recovery - Licensee's Expenses).
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
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Article 12: NEGATION OF WARRANTIES AND INDEMNIFICATION
Paragraph 12.05 is amended to read as follows:
12.05 Licensee shall indemnify and hold PHS, its employees, students,
fellows, agents, and consultants (the "Indemnified Parties")
harmless from and against all liability, demands, damages,
expenses, and losses, including but not limited to death,
personal injury, illness, or property damage (the "Indemnified
Losses") suffered by an Indemnified Party in connection with or
arising out of: a) the use by or on behalf of Licensee, its
sublicensees, directors, employees, or third parties of any
Licensed Patent Rights, or b) the design, manufacture,
distribution, or use of any Licensed Products, Licensed
Processes or materials by Licensee, or other products or
processes developed in connection with or arising out of the
Licensed Patent Rights. Licensee agrees to maintain a liability
insurance program consistent with sound business practice.
Notwithstanding any other provision to the contrary, Licensee
shall have no obligation to indemnify an Indemnified Party from
an Indemnified Loss in connection with or arising out of the
design, manufacture, distribution or use of any Licensed Product
or Licensed Process by or on behalf of the Indemnified Party.
Article 13. TERM, TERMINATION AND MODIFICATION OF RIGHTS
Paragraphs 13.01, 13.03, 13.05, 13.06 and 13.09 are amended to read as follows:
13.01 This Agreement is effective when signed by all parties and shall
extend on a country by country basis to the expiration of the
last to expire of the Licensed Patent Rights in each respective
country unless sooner terminated as provided in this Agreement.
13.03 In the event that Licensee becomes insolvent, files a petition
in bankruptcy, 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,
Licensee shall immediately notify PHS in writing, and PHS shall
thereupon have the right to terminate this Agreement.
13.05 PHS shall specifically have the right to terminate or, with
Licensee's consent, modify, at its option, this Agreement, if
PHS determines that the Licensee: 1) is not using its reasonable
best efforts to execute the Commercial Development Plan
submitted with its request for a license and the Licensee cannot
otherwise demonstrate to PHS's satisfaction that the Licensee
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; 2) has not used its reasonable
best efforts to achieve the Benchmarks as may be modified under
Paragraph 9.02; 3) has willfully made a false statement of, or
willfully omitted, a material fact in the license application or
in any report required by this Agreement; 4) has committed a
material breach of a covenant or agreement contained in the
license; 5) is not keeping Licensed Products or Licensed
Processes reasonably available to the public after commercial
use commences; 6) cannot reasonably satisfy unmet health and
safety needs; or 7) cannot reasonably justify a failure to
comply with the domestic production requirement of Paragraph
5.02 unless waived. In making this determination, PHS 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 Licensee under
Paragraph 9.02. Prior to invoking this right, PHS shall give
written notice to Licensee providing Licensee specific notice
of, and a ninety (90) day opportunity to respond to, PHS's
concerns as to the previous items 1) to 7). If Licensee fails to
alleviate PHS's concerns as to the previous items 1) to 7) or
fails to initiate corrective action to PHS's reasonable
satisfaction, PHS may terminate this Agreement.
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13.06 When the public health and safety so require, and after written
notice to Licensee providing Licensee a sixty (60) day
opportunity to respond, PHS shall have the right to require
Licensee to grant sublicenses to responsible applicants, on
commercially reasonable terms, in any Licensed Fields of Use
under the Licensed Patent Rights, unless Licensee 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. PHS will not
require the granting of a sublicense, as provided in this
Paragraph 13.06, unless the responsible applicant has first
negotiated in good faith with Licensee.
13.09 Within ninety (90) days of expiration or termination of this
Agreement under this Article 13, a final report shall be
submitted by Licensee. Any royalty payments, including those
incurred but not yet paid (such as the full minimum annual
royalty), and those related to patent expense, due to PHS 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
PHS and Licensee pursuant to Paragraph 4.03.
New Paragraph 13.10 is added to this Agreement and reads as follows:
13.10 Any expiration or termination of this Agreement shall not
preclude Licensee from exercising any rights it may have under
applicable law with respect to the commercial or other
exploitation of the Licensed Patent Rights.
Article 14. GENERAL PROVISIONS
Paragraphs 14.01, 14.03, 14.06, 14.07, 14.10 through 14.11, are amended to read
as follows:
14.01 Neither Party may waive or release any of its rights or
interests in this Agreement except in writing. The failure of
either Licensee or the Government 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 such
Party or excuse a similar subsequent failure to perform any such
term or condition by the other Party.
14.03 The provisions of this Agreement are severable, and in the event
that any provision of this Agreement shall be determined by a
court of competent jurisdiction 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 the Agreement.
14.06 All notices required or permitted by this Agreement shall be
given by prepaid, first class, registered or certified mail or
by a national express/overnight delivery service, properly
addressed to the other Party at the address designated on the
Signature Page hereto, or to such other address as may be
designated in writing by such other Party. A notice shall be
considered timely if such notice is received on or before the
established deadline date or sent on or before the deadline date
as verifiable by U.S. Postal Service postmark or dated receipt
or other form indicating the date of deposit with a national
express/overnight delivery service.
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14.07 This Agreement shall not be assigned by Licensee except: a) with
the prior written consent of PHS, such consent not to be
withheld unreasonably; or b) without the prior written consent
of PHS, to the successor of that part Licensee's business to
which this Agreement pertains. Licensee shall notify PHS within
ten (10) days of any assignment of this Agreement by Licensee,
and Licensee shall pay PHS, as an additional royalty, [ * ] of
the fair market value of any consideration received for any
assignment of this Agreement within thirty (30) days of such
assignment.
14.10 Licensee agrees to xxxx the Licensed Products or their packaging
sold in the United States with all applicable U.S. patent
numbers and similarly to indicate "Patent Pending" status. All
Licensed Products manufactured in, shipped to, or sold in other
countries shall be marked in such a manner as to preserve PHS's
and Licensee's patent rights in such countries, if any.
14.11 By entering into this Agreement, PHS does not directly or
indirectly endorse any product or service provided, or to be
provided, by Licensee whether directly or indirectly related to
this Agreement. Licensee shall not state or imply that this
Agreement is an endorsement by the Government, PHS, any other
Government organizational unit, or any Government employee.
Additionally, Licensee shall not use the names of NIH, CDC, PHS,
or DHHS or the Government or their employees in any advertising,
promotional, or sales literature without the prior written
consent of PHS, except that Licensee may publicly identify the
existence of this Agreement and is not prohibited from using
publicly available factual information regarding the Licensed
Patent Rights, Licensed Products, and Licensed Processes
specifically including, but not limited to, the names of the
inventors as they appear on the Licensed Patent Rights and their
associated NIH institutes, without such consent.
New Paragraphs 14.15 through 14.16 are added to this Agreement and read as
follows:
14.15 Upon termination or expiration of this Agreement, Licensee and
any sublicensee or Affiliates shall be entitled to sell any
Licensed Products manufactured prior to the date of such
termination or expiration for up to an additional six (6) month
period subject to the obligations of Articles 6, 8 and 9.
14.16 To the extent permitted by law, government regulation and PHS
policy, PHS agrees to maintain in confidence and not disclose
any confidential information provided by Licensee to PHS under
this Agreement or the terms and conditions of this Agreement.
Licensee will xxxx such information as confidential.
The remainder of this page intentionally left blank
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
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APPENDIX E--Benchmarks and Performance
Licensee agrees to the following Benchmarks for its performance under this
Agreement and, within thirty (30) days of achieving a Benchmark, shall notify
PHS that the Benchmark has been achieved.
RegeneRx Biopharmaceuticals Inc. (RegeneRx) intends to develop the Licensed
Product for Wound Healing. [ * ]
The remainder of this page intentionally left blank
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
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[ * ]
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
PHS Patent License Agreement--Exclusive CONFIDENTIAL L-268-99/0
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APPENDIX F--Commercial Development Plan
[ * ]
"[ * ]" = omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a request for
confidential treatment.
PHS Patent License Agreement--Exclusive CONFIDENTIAL L-268-99/0
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PHS Patent License Agreement--Exclusive CONFIDENTIAL L-268-99/0
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