1
EXHIBIT 1.9
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT--NONEXCLUSIVE
COVER PAGE
For PHS internal use only:
Patent License Number:
L-176-99/0
Serial Number(s) of Licensed Patent(s) and/or Patent Application(s):
U.S. Patent Applications Serial No. 06/330,959 (U.S. Patent 4,522,918,
issued June 11, 1985) and Serial No. 06/707,400 (U.S. Patent 4,612,282,
issued September 16, 1986).
Licensee:
AltaRex Corp.
Cooperative Research and Development Agreement (CRADA) Number (if
applicable):
Not applicable.
Additional Remarks:
None.
Public Benefit(s):
Development of therapeutic agent against ovarian cancer.
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). 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) The person, corporation, or institution identified above and/or on the
Signature Page, having offices at the address indicated on the
Signature Page, hereinafter referred to as "LICENSEE".
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PHS PATENT LICENSE AGREEMENT--NONEXCLUSIVE
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 regardless of whether United States or foreign patent
applications or patents claiming such inventions exist.
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 and/or
the tangible embodiments thereof.
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 and/or certain tangible embodiments thereof 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 for use or
consumption by the general public 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,
after the required approvals have been granted by the appropriate
regulatory authority, in exchange for cash or some equivalent to which
value can be assigned.
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;
b) to the extent that the following contain one or more claims
directed to the invention or inventions disclosed in a) above:
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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:
a) tangible materials which, in the course of manufacture, use,
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; and
b) LICENSED MATERIALS.
2.09 "LICENSED MATERIALS" means:
a) the tangible materials identified in Appendix A; and
b) all materials, including progeny, subclones, derivatives,
modifications, fractions or components, derived or isolated from
tangible materials by LICENSEE.
2.10 "LICENSED TERRITORY" means the geographical area identified in
Appendix B.
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.
3. GRANT OF RIGHTS
3.01 PHS hereby grants and LICENSEE accepts, subject to the terms and
conditions of this AGREEMENT, a nonexclusive 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.
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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 or utilizing LICENSED PRODUCT(S) only to the
extent that such sublicensing agreements include patent rights other
than LICENSED PATENT RIGHTS, or other proprietary technology of
LICENSEE.
4.02 LICENSEE agrees that any sublicenses granted by it shall provide that
the obligations to PHS of Paragraphs 5.01, 5.02, 9.01, 9.02, 11.05,
and 12.06-12.08 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 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 for internal, non-commercial research
use only.
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.
6. ROYALTIES AND REIMBURSEMENT
6.01 LICENSEE agrees to pay to PHS a noncreditable, nonrefundable license
issue royalty as set forth in Appendix C.
7. PATENT FILING, PROSECUTION, AND MAINTENANCE
7.01 PHS agrees to take responsibility for the preparation, filing,
prosecution, and maintenance of any and all patent applications or
patents included in the LICENSED PATENT RIGHTS.
8. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
8.01 Prior to signing this AGREEMENT, LICENSEE has provided, in confidence,
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.
8.02 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
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include, but not be limited to: progress on research and development,
status of applications for regulatory approvals, manufacturing,
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.
8.03 LICENSEE shall report to PHS the dates for achieving BENCHMARKS
specified in Appendix E and the FIRST COMMERCIAL SALE in the LICENSED
TERRITORY within thirty (30) days of such occurrences.
8.04 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
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.
8.05 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.
8.06 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.
8.07 All plans and reports required by this Article 8 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. [ ] 552 shall be subject to the predisclosure
notification requirements of 45 CFR [ ] 5.65(d).
9. PERFORMANCE
9.01 LICENSEE shall use its reasonable diligent efforts to bring the
LICENSED PRODUCTS AND LICENSED PROCESSES to PRACTICAL APPLICATION.
"Reasonable diligent 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 E.
9.02 Upon the FIRST COMMERCIAL SALE, until the expiration of this
AGREEMENT, LICENSEE shall use its reasonable diligent efforts to make
LICENSED PRODUCTS and LICENSED PROCESSES reasonably accessible to the
United States public.
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10. INFRINGEMENT AND PATENT ENFORCEMENT
10.01 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.
10.02 In the event that a declaratory judgment action alleging invalidity
of any of the LICENSED PATENT RIGHTS shall be brought against PHS,
PHS agrees to notify LICENSEE that an action alleging invalidity has
been brought. PHS does not represent that it will commence legal
action to defend against a declaratory action alleging invalidity.
LICENSEE shall take no action to compel the GOVERNMENT either to
initiate or to join in any such declaratory judgment action. 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. Upon LICENSEE'S payment of all costs
incurred by the GOVERNMENT as a result of LICENSEE'S joinder motion
or other action, these actions by LICENSEE will not be considered a
default in the performance of any material obligation under this
AGREEMENT.
11. NEGATION OF WARRANTIES AND INDEMNIFICATION
11.01 PHS offers no warranties other than those specified in Article 1.
11.02 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.
11.03 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.
11.04 PHS does not represent that it will commence legal actions against
third parties infringing the LICENSED PATENT RIGHTS.
11.05 No indemnification for any loss, claim, damage or liability is
intended or provided by any party under this AGREEMENT. Each party
shall be liable for any loss, claim, damage or liability that said
party incurs as a result of its activities under this AGREEMENT,
except that PHS, as an agency of the United States, assumes liability
only to the extent provided under the Federal Tort Claims Act, 28
U.S.C. 2671 et seq.
12. TERM, TERMINATION, AND MODIFICATION OF RIGHTS
12.01 This AGREEMENT, when signed by all parties, is effective as of
September 11, 1997, which is the date upon which Licensee obtained
the tangible material(s) identified in Appendix A, and shall extend
to June 11, 2002, which is the date of expiration of the last to
expire of the LICENSED PATENT RIGHTS, or such earlier date if the
LICENSED PATENT RIGHTS are held invalid or unenforceable by an
unappealed or unappealable judgment of a court of competent
jurisdiction in the LICENSED TERRITORY prior to June 11, 2002, unless
sooner terminated as provided in this Article 12.
12.02 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 12.05, and if the default has
not been remedied within ninety (90) days after the date of notice in
writing of such default,
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PHS may terminate this AGREEMENT by written notice and pursue
outstanding amounts owed through procedures provided by the Federal
Debt Collection Act.
12.03 In the event that LICENSEE becomes insolvent, files a Chapter 7
petition in bankruptcy, has such a petition filed against it or
receives notice of a third party's intention to file an involuntary
Chapter 7 petition in bankruptcy and such bankruptcy proceeding is
not dismissed within ninety (90) days of filing, LICENSEE shall
immediately notify PHS in writing. Furthermore, PHS shall have the
right to terminate this Agreement immediately upon receipt of
LICENSEE'S written notice.
12.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT in
any country or territory by giving PHS sixty (60) days written notice
to that effect.
12.05 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
8.02; 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
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 8.02. 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 6). If LICENSEE fails to alleviate PHS'S
concerns as to the previous items 1) to 6) or fails to initiate
corrective action to PHS'S satisfaction, PHS may terminate this
AGREEMENT.
12.06 PHS reserves the right according to 35 U.S.C. [ ] 209(f)(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.
12.07 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 CFR 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.
12.08 Within ninety (90) days of expiration or termination of this
AGREEMENT under this Article 12, a final report shall be submitted by
LICENSEE. Unless otherwise specifically provided for under this
AGREEMENT, upon termination 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. Unless otherwise specifically provided for under
this AGREEMENT, upon expiration of this AGREEMENT, LICENSEE shall not
return all LICENSED PRODUCTS or other materials included within the
LICENSED PATENT RIGHTS to PHS or provide PHS with certification of
the destruction thereof.
13. GENERAL PROVISIONS
13.01 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
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GOVERNMENT or excuse a similar subsequent failure to perform any such
term or condition by LICENSEE.
13.02 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.
13.03 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.
13.04 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.
13.05 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.
13.06 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 Party. 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.
13.07 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.
13.08 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 CFR Part 50 and
45 CFR 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 thirty (30) days prior to
commencement of such research or trials.
13.09 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.
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13.10 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.
13.11 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.
13.12 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 12. 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.
13.13 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 CFR Part 404
shall not be immunized from the operation of state or Federal law by
reason of the source of the grant.
13.14 Paragraphs 2.03, 2.08, 2.09, 6.01, 8.03, 8.05-8.07, 11.01-11.05,
12.07, 12.08, and 13.12 of this AGREEMENT shall survive termination
or expiration of this AGREEMENT, with the exception that any royalty
payments under Paragraph 6.01 which have not yet been incurred
(excluding the first payment which is due and payable within thirty
(30) days from the date this AGREEMENT is signed by all parties), and
the reporting of any BENCHMARKS reportable to PHS under Paragraph
8.03 which have not yet been achieved, shall not survive if the
LICENSED PATENT RIGHTS are held invalid or unenforceable by an
unappealed or unappealable judgment of a court of competent
jurisdiction in the LICENSED TERRITORY prior to June 11, 2002.
SIGNATURES BEGIN ON NEXT PAGE
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PHS PATENT LICENSE AGREEMENT--NONEXCLUSIVE
SIGNATURE PAGE
For PHS:
/s/ Xxxx Xxxxxxx 9/21/99
---------------------------------------------- --------------------------
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/ Xxxxxxx X. Xxxxxx 9/13/99
--------------------------------------------- --------------------------
Signature of Authorized Official Date
Xxxxxxx X. Xxxxxx
---------------------------------------------
Printed Name
President
---------------------------------------------
Title
Official and Mailing Address for Notices:
AltaRex Corp.
000 Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
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. [ ][ ] 3801-3812
(civil liability) and 18 U.S.C. [ ] 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):
U.S. Patent Application Serial Number 06/330,959 (U.S. Patent 4,522,918,
issued June 11, 1985), entitled "Process for Producing Monoclonal
Antibodies Reactive With Human Breast Cancer", and
U.S. Patent Application Serial Number 06/707,400 (U.S. Patent 4,612,282,
issued September 16, 1986), entitled "Monoclonal Antibodies Reactive With
Human Breast Cancer".
TANGIBLE MATERIAL(S):
Hybridoma Cell Line #HB-8108 (deposited in the ATCC by PHS); and
Xxxxxxxx X00.0.
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APPENDIX B--LICENSED FIELDS OF USE AND TERRITORY
LICENSED FIELDS OF USE:
Agents for the prevention and treatment of ovarian and other cancers in
humans.
LICENSED TERRITORY:
The United States of America, its territories and possessions, the District
of Columbia, and the Commonwealth of Puerto Rico.
PHS Patent license Agreement -- Nonexclusive CONFIDENTIAL L-176-99/0
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13
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX C--ROYALTIES
ROYALTIES:
LICENSEE agrees to pay to PHS a noncreditable, nonrefundable license issue
royalty in the amount of [**] as follows:
A first payment of [**] shall be due and payable within thirty (30) days
from the date that this AGREEMENT is signed by all parties;
A second payment of [**] shall be due and payable upon the first to occur
of submission by LICENSEE or its sublicensee(s) of the first Product
License Application, or equivalent, for the LICENSED PRODUCT(S) in the
LICENSED TERRITORY, or execution of the first corporate partnership or
sublicensing agreement for the LICENSED PRODUCT(S) in the LICENSED
TERRITORY; and
A third payment of [**] shall be due and payable upon FIRST COMMERCIAL SALE
in the LICENSED TERRITORY.
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APPENDIX D--MODIFICATIONS
PHS and LICENSEE agree to the following modifications to the Articles and
Paragraphs of this AGREEMENT:
None.
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15
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.
Submission of IND: July, 2001.
Execution of first corporate partnership or sublicensing agreement for the
LICENSED PRODUCT(S) in the LICENSED TERRITORY: upon occurrence.
Submission of first Product License Application, or equivalent, in the
LICENSED TERRITORY: upon occurrence.
FIRST COMMERCIAL SALE in the LICENSED TERRITORY: upon occurrence.
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APPENDIX F--COMMERCIAL DEVELOPMENT PLAN
Refer to License Application (attached).
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17
APPLICATION FOR LICENSE TO PUBLIC HEALTH SERVICE INVENTIONS
Thank you for your interest in the technology transfer activities of the
U.S. Public Health Service. Your answers to the following questions will provide
the foundation for licensing decisions. Please return this form and the required
attachments to: OFFICE OF TECHNOLOGY TRANSFER, NATIONAL INSTITUTES XX XXXXXX,
XXX XXX, XXXXXXXX, XX 00000.
IDENTIFICATION OF INVENTION(S) FOR WHICH LICENSE IS SOUGHT
(Complete all relevant sections)
U.S. Patent Numbers:
4,552,918 AND 4,612,282
Title of Patents:
"PROCESS FOR PRODUCING MONOCLONAL ANTIBODIES REACTIVE WITH HUMAN BREAST CANCER"
AND
"MONOCLONAL ANTIBODIES REACTIVE WITH HUMAN BREAST CANCER"
Biological Material(s): N/A
Inventor(s): XXXXXXX XXXXXX, ET. AL.
INFORMATION ABOUT APPLICANT
1. Name and Address of Applicant:
ALTAREX CORP.
000 XXXXX XXXXXX
XXXXX 000
XXXXXXX, XX
00000
2. Name, title, address, phone and FAX numbers of Applicant's licensing
representative:
XXXXX XXXXXXX
BUSINESS DEVELOPMENT ASSOCIATE
000 XXXXX XXXXXX
XXXXX 000
XXXXXXX, XX
00000
PHONE: 000-000-0000 EXT. 228
FAX: 000-000-0000
18
3. Is Applicant a U.S. Corporation?
ALTAREX CORP. IS A CANADIAN PUBLIC COMPANY DIRECTING BUSINESS OPERATIONS
FROM A WHOLLY-OWNED U.S. SUBSIDIARY, ALTAREX, U.S. CORP.
4. Is Applicant a Small Business Firm? x yes no
----- ------
TYPE OF LICENSE SOUGHT
Exclusive Commercialization License
----------
Coexclusive Commercialization License
----------
x Nonexclusive Commercialization License (THERAPEUTIC USE ONLY)
----------
Nonexclusive Internal Commercial Use License (internal
----------
use only - no right to sell or otherwise distribute materials)
Nonexclusive Biological Materials License (for materials
----------
not covered under a patent or patent application)
Commercial Evaluation License (for a limited-term evaluation)
----------
PROPOSED FIELD(S) OF USE:
THERAPEUTIC TREATMENT OF CANCER.
PLEASE SEE ATTACHED FOR THE FOLLOWING INFORMATION:
I. DESCRIPTION OF APPLICANT
II. OTHER LICENSES AND USE OF THE INVENTION
III. PROPOSED LICENSE TERMS
IV. RESEARCH, DEVELOPMENT AND MARKETING PLAN
V. OTHER INFORMATION WHICH YOU BELIEVE WILL SUPPORT A DETERMINATION TO
GRANT THE REQUESTED LICENSE
/s/ Xxxxx Xxxxxxx
------------------------------------------------------------------------------
Signature of Applicant or Authorized Representative
April 15, 1999
---------------------------
Date
Xxxxx Xxxxxxx, Business Development Associate
-------------------------------------------------------------------------------
Print Name and Title
The commercial and financial responses in this application will be treated as
privileged and confidential information as provided in 15 U.S.C. 209(a); and, to
the extent permitted by law, will not be accessible under the Freedom of
Information Act.
19
ATTACHMENT TO APPLICATION FOR LICENSE
TO PUBLIC HEALTH SERVICE INVENTIONS
U.S. Patent No. 4,522,918
"Process for producing monoclonal antibodies reactive with human breast cancer"
and
U.S. Patent No. 4,612,282
"Monoclonal antibodies reactive with human breast cancer"
I. DESCRIPTION OF THE APPLICANT
AltaRex Corp. is an emerging biotechnology company focused on the research,
development and commercialization of unique antibody-based immunotherapeutics
for the treatment of cancers. The Company's products are based on its unique
proprietary platform technology, anti-idiotype induction therapy or AIT(R).
Based upon research and clinical studies to date, AltaRex believes that its
AIT(R) technology enhances the ability of the human immune system to produce its
own anti-tumor response. The Company has filed five patent applications for its
AIT(R) technology in the United States of America. Four of these patents have
been or will be the subject of worldwide patent filings.
The Company's objective is to develop unique, patent protected products for
commercialization primarily by pharmaceutical partners.
The Company's business strategy has been to focus on developing therapeutic
antibodies for cancer. AltaRex's products are modified murine monoclonal
antibodies or MAbs developed by the Company's scientists or licensed to the
Company. The Company believes that these MAbs may be used effectively in
conjunction with traditional cancer therapies and may be applicable to treating
7 of the top 10 cancer killers in the U.S. By pursuing this line of research
AltaRex scientists have developed a sophisticated understanding of the immune
system and expertise in immune modulating technology.
AltaRex's lead antibody product, OvaRexTM MAb, is in late stage clinical
development. The Company is currently conducting two potentially pivotal phase
IIb clinical trials for women who have been diagnosed with stage III or IV
disease and who have had a complete clinical response to their initial surgery
and chemotherapy. These are double-blinded, placebo-controlled trials designed
to increase time to disease relapse and ultimately survival. These trials are
being conducted in a patient population where there is currently no approved
treatment option.
The Company is also conducting two open-label trials of OvaRexTM MAb in women
who have experienced disease relapse. These trials are designed to provide the
Company with important immunology data.
AltaRex has 38 employees, 26 of whom are located at the Company's facilities in
Edmonton, Alberta and 12 of whom are located at its office in Waltham,
Massachusetts. There are 20 employees working in research and development and 18
working in administration and corporate affairs. Employees include several
Ph.D.'s and two M.D.'s.
AltaRex had revenues of CDN$1.0 million for the year ended December 31, 1998.
For the year ended December 31, 1998, the Company had a net loss of CDN$13.1.
Approximately 67% of the Company's expenses in 1998 were devoted to scientific
research and development activities. The majority of this investment is devoted
to the Company's lead product, OvaRexTM MAb, which is currently undergoing
potentially pivotal phase IIb clinical trials. Cash and short-term investments
as at December 31, 1998 were CDN$12.8 million. The Company is currently in the
process of raising up to CDN$17 million in the public markets to facilitate
further development of its programs.
AltaRex has assembled a strong management team and Board of Directors with
significant expertise in the area of drug development and has a commitment to
developing products that will provide a significant benefit to society.
20
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
II. OTHER LICENSES AND USE OF THE INVENTION
AltaRex does not have license to any federally owned inventions. The Company has
applied for a license for U.S. Patent Application Number 09/020,116 for the
treatment of allergic diseases. AltaRex believes that the license for the
invention being applied for in this document is held by several organizations on
a non-exclusive basis.
III. PROPOSED LICENSE TERMS
A. LICENSED PATENTS/TECHNOLOGY
U.S. Patent No. 4,522,918 "Process for producing monoclonal antibodies reactive
with human breast cancer" and U.S. Patent No. 4,612,282 "Monoclonal antibodies
reactive with human breast cancer" or upon any divisions, continuations,
reissues, reexamines, extensions and any claims in continuations-in-part
applications; and any and all foreign patents, extensions and supplemental
protection certificates or patent applications corresponding thereto.
B. SCOPE OF LICENSE
In return for a non-exclusive, worldwide, sublicensable license to the above
mentioned Licensed Patents for all mammalian uses, until the expiration of such
Licensed Patents, AltaRex Company (AltaRex) will make the following payments to
the National Institutes of Health (NIH):
C. LICENSE TERMS
I. LICENSE PAYMENT US$[**] UPON SIGNING
II. MILESTONE PAYMENTS for a product covered
by issued or pending claims of the Licensed
Patents:
Upon approval of an NDA or equivalent US$[**]
application with the FDA
III. ROYALTY PAYMENTS
For a product that is covered by valid [**]% OF NET SALES
unexpired claims of the Licensed Patents
D. SUBLICENSE
AltaRex has the right to sublicense the technology, and will inform NIH of all
sublicenses. AltaRex will remain responsible for paying the milestone and
royalty payments.
IV. RESEARCH, DEVELOPMENT AND MARKETING PLAN
AltaRex intends to further develop the licensed technology, in concert with its
own proprietary AIT(R)-based technology, into a product or products that are
capable of providing a therapeutic effect for cancer patients. The Company has
attained certain expertise relating to a novel antibody-based approach to cancer
therapy. The Company is currently in late-stage clinical development of an
antibody immunotherapeutic for ovarian cancer and is currently conducting four
separate trials at 65 trial sites. The technology being sought in this
application has some existing and promising clinical data associated with
ovarian cancer and it is the intent of the Company to initially develop products
for therapeutic applications for ovarian cancer.
00
XxxxXxx plans to use its proprietary AITTM technology to further develop the
technology outlined in the patents. The Company believes that there is
sufficient clinical data to support a positive safety profile for the B72.3
antibody (covered by the patents) and plans to initially submit an IND
application to the U.S. FDA for a potentially pivotal phase IIb trial for the
treatment of ovarian cancer.
The Company anticipates that an ovarian cancer product derived from the
technology would be used in an ovarian cancer patient population where there is
currently no approved therapy. As such, the Company believes that due to the
deadly nature of the disease that it will be able to petition for, and receive,
FDA Fast Track Designation and would thereby considerably reduce the amount of
time required for product commercialization.
AltaRex will also evaluate other antibodies covered by the patents to determine
the applicability to other cancers and, if appropriate, will take the necessary
measures to develop additional products.
The mechanism of action of the Corporation's AIT(R) technology is based on what
the Corporation believes is the ability of the human immune system to generate a
highly specific immune response to low doses of injected MAbs associated with
specific TAAs. The Corporation believes that certain murine MAbs may, upon
administration to a cancer patient, produce both a humoral and a cellular
response by the patient's immune system.
Estimated time to therapeutic development (for ovarian cancer indication):
Compilation of previous data and preparation of IND - July, 2001.
Potentially pivotal Phase IIb trial and BLA submission and approval - Completion
anticipated after June, 2002.
V. MARKET ANALYSIS
In the United States, Canada and Europe, ovarian cancer causes more deaths than
any other cancer of the female reproductive tract. It is estimated that in the
United States more than 25,400 new cases of ovarian cancer will be diagnosed and
more than 14,000 women will die from this disease annually (American Cancer
Society, 1998 Cancer Facts & Figures). The Corporation has received Orphan Drug
Status and Fast Track Designation for OvaRexTM MAb for this indication and
believes that the same opportunities would be available for the licensed
patents.
Although detection of the tumor at an early stage is now associated with an
improved chance for curative treatment, survival figures have not changed
significantly over the past 15 years. This is partially due to a lack of
efficient diagnostic methods or markers for routine tests that could increase
the number of patients diagnosed at the early stage of their disease.
Consequently, in most diagnosed patients (75%), the tumor has already progressed
to an advanced stage (Stage III or IV), making therapeutic approaches more
difficult. The five-year survival rates for women with regional and distant
ovarian cancer are 49% and 23%, respectively (American Cancer Society, 1996
Cancer Facts & Figures). Patients diagnosed with advanced ovarian cancer usually
demonstrate a survival time of less than two years (Xxxxxxx et al., Journal of
Clinical Oncology, October 1992).
Worldwide market estimates for effective therapeutics for late-stage ovarian
cancer range from $400 million to $800 million annually.
VI. OTHER INFORMATION
In developing the Company's four cancer products, AltaRex scientists have
developed a sophisticated understanding of the immune system and expertise in
immune modulating technology. AltaRex scientists are engaged in leading edge
immunology research and have developed particular expertise in protein
engineering and purification techniques. Through its OvaRexTM MAb program, the
Company has also gained considerable expertise in the area of ovarian cancer.
In addition, AltaRex has assembled a strong management team with considerable
drug development experience. AltaRex's founding scientist and Chairman, Xxxxxxx
Xxxxxxx, Ph.D., was also a founder of Biomira, a Canadian biotechnology company
also developing cancer therapeutics. Xx. Xxxxxxx has extensive expertise in the
22
development of radiopharmaceuticals and has established AltaRex as the
world-leader in the use of anti-idiotype induction technology.
Xxxxxxx Xxxxxx, President and CEO, has over 30 years of experience in health
care. His experience includes prescription pharmaceuticals, consumer products
and biotechnology. He has held senior management positions at ProScript, Inc.,
ImmuLogic Pharmaceutical Company, Squibb Corp. and SmithKline. While at
ProScript, Xx. Xxxxxx directed the development of small molecule therapeutics
for cancer and inflammatory disease.
The Senior Vice President of Medical and Regulatory Affairs, Xxxxxxxxxxx
Xxxxxxxxx, M.D., is Board Certified in Internal Medicine, and in Allergy and
Clinical Immunology. He trained at, and remains affiliated with the Department
of Rheumatology and Immunology at Xxxxxxx and Women's Hospital, Harvard Medical
School. He has extensive drug development experience including positions at
Pfizer Labs, ImmuLogic Pharmaceutical Company, and Diatide, Inc. Xx. Xxxxxxxxx
has participated in the development and registration of multiple products.
