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EXHIBIT 10.23
NON-EXCLUSIVE LICENSE AGREEMENT
[As Amended by FHCRC and Licensee on December 1, 2000]
This Agreement is entered into as of the 20th day of October, 1999
("Effective Date") by and between the Xxxx Xxxxxxxxxx Cancer Research Center, a
Washington non-profit corporation ("FHCRC") and Xcyte Therapies, Inc
("LICENSEE"), a Delaware corporation having a place of business at 0000 Xxxxxxx
Xxx X., Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000. All references to LICENSEE shall
include its AFFILIATES.
RECITALS
A. FHCRC has developed and owns the valuable [*];
B. FHCRC is committed to a policy that ideas or creative works produced
at FHCRC should be used for the greatest possible public benefit and believes
that every reasonable incentive should be provided for the prompt introduction
of such ideas into public use, all in a manner consistent with the public
interest;
C. LICENSEE desires to obtain a worldwide license in and to the
above-referenced rights; and
D. FHCRC is willing to grant such a license to LICENSEE subject to the
terms and conditions of this Agreement.
TERMS AND CONDITIONS
The parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 "AFFILIATE" shall mean any corporation or other entity which is directly or
indirectly controlling, controlled by or under the common control with a party
hereto which has agreed in writing to be bound by the terms of this Agreement.
For the purpose of this Agreement, "control" shall mean the direct or indirect
ownership of at least thirty percent (30%) of the outstanding shares or other
voting rights of the subject entity to elect directors, or if not meeting the
preceding, any entity owned or controlled by or owning or controlling at the
maximum control or ownership right permitted in the country where such entity
exists. "Affiliates" includes only Affiliates of LICENSEE and does not include
Affiliates of LICENSEE's Affiliates.
1.2 "LICENSED CELL LINE" means the [*]. Such derivatives and modifications shall
not include antibodies which are not derived from or developed using the
Licensed Materials and which have been entirely made with the use of information
or materials available in the public domain.
1.3 "LICENSED MONOCLONAL ANTIBODY" means the [*], produced by or derived from
the licensed CELL LINE.
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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1.4 "LICENSED PRODUCTS" means any product, including reagents, devices, kits and
packages that contain, or are derived from, or result from the use of the
LICENSED MONOCLONAL ANTIBODY including without limitation beads coated with the
LICENSED MONOCLONAL ANTIBODY either by itself or in combination with other
antibodies. LICENSED PRODUCTS does not include the LICENSED CELL LINE.
1.5 "LICENSED SERVICES" means any service performed for a third party using a
LICENSED PRODUCT or the LICENSED MONOCLONAL ANTIBODY. Services performed on
biological materials from a single patient which are clinically defined to
constitute a single course of treatment shall constitute the performance of a
single LICENSED SERVICE procedure for purposes of Section 5.2 of this Agreement.
1.6 "FIELD" means [*].
1.7 "NET SALES" means the amount actually received by LICENSEE and its
AFFILIATES or sublicensees on sales of LICENSED PRODUCTS and LICENSED SERVICES
less:
(a) Customary trade, quantity or cash discounts and non-affiliated
brokers' or agents' commissions actually allowed and taken;
(b) Amounts repaid or credited by reason of rejection or return; and/or
(c) To the extent separately stated on purchase orders, invoices or
other documents of sales, taxes levied on and/or other governmental
charges made as to production, sale, transportation, delivery or use and
paid by or on behalf of LICENSEE; and/or Import and I or export duties
actually paid.
(d) NET SALES shall include all consideration received for a sale and
shall be based on the usual full arms length third party price in the
event that LICENSED PRODUCT is transferred at a lower sum.
ARTICLE 2 - GRANT
2.1 Non-Exclusive License. FHCRC hereby grants to LICENSEE and LICENSEE accepts
subject to the terms and conditions hereof the following licenses:
(a) a non-exclusive license to use, possess, culture and employ the
LICENSED CELL LINE at its business premises solely in the United States;
(b) a worldwide, non-exclusive license to the LICENSED MONOCLONAL
ANTIBODY to make and have made, to use, to sell, have sold and offer for
sale the LICENSED PRODUCTS and the LICENSED SERVICES in the FIELD for
the term of this Agreement (collectively the "Licenses").
Notwithstanding any other provision of this Agreement, (1) LICENSEE and
its Affiliates shall not use the LICENSED CELL LINE or LICENSED
MONOCLONAL ANTIBODY for any purpose other than that expressly described
in this Agreement (2) shall not transfer the LICENSED CELL LINE to any
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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third party or AFFILIATE for any purpose except to a sublicensee as
provided in Section 2.2(a) of this Agreement and (3) shall in no event
transfer the LICENSED CELL LINE outside of the United States.
2.2 Sublicensing
(a) LICENSEE shall have no right or power to grant sublicenses of the
LICENSED CELL LINE, under section 21. (a), except LICENSEE shall have
the right to sublicense third parties to make the LICENSED MONOCLONAL
ANTIBODY on behalf of LICENSEE solely for the use of LICENSEE, its
AFFILIATES and sublicensees subject to FHCRC's prior written consent,
which consent shall not be unreasonably withheld. If FHCRC does not
respond in thirty (30) days to written request for consent from
LICENSEE, such non-response shall constitute consent by FHCRC hereunder.
In addition to any other requirements imposed under this Agreement, a
sublicense of the LICENSED CELL LINE shall require that the LICENSED
CELL LINE be maintained in and not transferred from the United States
and will prohibit the sublicensee from sublicensing or otherwise
transferring the LICENSED CELL LINE to any other person or entity. Upon
the prior written approval of FHCRC, which shall not be unreasonably
withheld, LICENSEE may sublicense on third party to make the LICENSED
MONOCLONAL ANTIBODY in Europe on behalf of LICENSEE solely for the use
of LICENSEE, its AFFILIATES and sublicensees upon terms and conditions
agreeable to FHCRC. A determination by FHCRC that a sublicense will
affect adversely its rights in the LICENSED CELL LINE or the LICENSED
MONOCLONAL ANTIBODY or its ability to enforce those rights shall be
deemed a reasonable basis to withhold consent to that sublicense for
purposes of this Section 2.2(a).
(b) LICENSEE may grant and authorize sublicenses to permit third parties
to perform LICENSED SERVICES and to make, have made, use and sell
LICENSED PRODUCTS (but not the LICENSED CELL LINE) within the scope of
the License described in Section 2.1(b) of this Agreement with FHCRC's
prior written consent, which consent will not be unreasonably withheld.
If FHCRC does not respond in thirty (30) days to written request for
consent from LICENSEE, such non-response shall constitute consent by
FHCRC hereunder. All sublicenses granted by LICENSEE under this Section
2.2(b) shall include a requirement that the sublicensesee use
reasonable efforts to introduce the LICENSED PRODUCTS into the
commercial market as soon as reasonably possible, consistent with sound
and reasonable business practices and judgment, and thereafter endeavor
to keep LICENSED PRODUCTS reasonably available to the public.
(c) In addition to any other requirements of this Agreement, any
sublicense agreement under this Section 2.2 shall bind the sublicensee
to meet all LICENSEE's obligations to FHCRC under this Agreement.
Royalties charged for sublicenses by LICENSEE shall be commercially
reasonable. LICENSEE shall promptly provide FHCRC with a copy of any
sublicense agreement subject to the confidentiality provisions of
Article 10 of this Agreement.
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(d) Notwithstanding 2.2 (a)-(c), LICENSEE may transfer the LICENSED
MONOCLONAL ANTIBODY to third parties, and if required by such third
party, sublicense the LICENSED MONOCLONAL ANTIBODY for the purpose of
testing, analysis, development or manufacturing of LICENSED PRODUCTS or
LICENSED SERVICES to be sold or offered for sale by LICENSEE or
authorized sublicensees; provided that the third party to whom the
transfer is made has agreed (1) in writing to use the LICENSED
MONOCLONAL ANTIBODY solely for that limited purpose and has agreed (2)
not to make, use or sell or offer for sale or otherwise distribute or
exploit the LICENSED MONOCLONAL ANTIBODY or any LICENSED PRODUCT or
LICENSED SERVICE and (3) to be bound by the Confidentiality provisions
in Article 10 of this Agreement.
2.3 Restrictions on License. Notwithstanding any other provision of this
Agreement, the License is subject to the following policies, obligations and/or
conditions:
(a) FHCRC's Patents and Inventions Policy adopted September 30, 1983,
Public Laws 96-517 and 98-620 and FHCRC's obligations under agreement
with other sponsors of research. Any right granted in this Agreement
greater than that permitted under Public Laws 96-5 17 or 98-620 shall be
subject to modification as may be required to conform to the provisions
of the statutes.
(b) LICENSEE agrees during the term of the License that any LICENSED
MONOCLONAL ANTIBODY produced for sale in the United States will be
manufactured substantially in the United States.
ARTICLE 3 - TERM OF AGREEMENT
3.1 Term. The term of this Agreement commences on the Effective Date and,
subject to earlier termination as provided in Article 9, shall remain in effect
for fifteen (15) years following the first sale of a LICENSED PRODUCT or
LICENSED SERVICE by LICENSEE to a customer who is not an AFFILIATE or
sublicensee ("First Commercial Sale"). Upon expiration of the term, provided
LICENSEE is not in material breach of this Agreement, the licenses granted
LICENSEE under this Agreement shall be deemed fully paid-up.
ARTICLE 4 - DELIVERY OF LICENSED MATERIAL
4.1 Delivery of [*]. Within thirty (30) days of receipt by FHCRC of any Signing
Fee owed under this Agreement, the Effective Date, FHCRC shall provide to
LICENSEE [*] from the Manufacturer's Working Cell Bank ("MWCB").
4.2 Replacement of [*]. If the [*] dies during the Term of this Agreement, FHCRC
will, after it has been reimbursed its reasonable costs and expenses by
LICENSEE, and no more than two occasions during the Term, provide to LICENSEE
sufficient quantities of additional seed stock from the MWCB to replace the cell
line, but in no event more then a total of two additional vials.
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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4.3 Antibody Production. The parties acknowledge that LICENSEE has contracted
with FHCRC for production and supply of the [*] pursuant to a Laboratory
Services Agreement dated even herewith.
ARTICLE 5 - PAYMENTS
5.1 Signing Fee. LICENSEE shall pay to FHCRC a non-refundable signing fee in the
sum of Fifty Thousand Dollars ($50,000). FHCRC acknowledges receipt of Twenty
Five Thousand Dollars ($25,000). The remaining Twenty Five Thousand Dollars
shall be due and payable within five (5) days of the Amendment Effective Date.
5.2 Earned Royalties. LICENSEE shall pay to FHCRC a royalty in the amount of [*]
of the NET SALES of all LICENSED PRODUCTS and [*] of the NET SALES of all
LICENSED SERVICES sold by LICENSEE during the Term. The royalty payable with
respect to the performance of a single LICENSED SERVICE procedure shall not
exceed [*] per single LICENSED SERVICE procedure (the "LICENSED SERVICES Royalty
Cap") for a period of three (3) years following the date of the first commercial
sale of a LICENSED SERVICE hereunder. Thereafter, the LICENSED SERVICES Royalty
Cap shall increase at the rate of [*] per calendar year. LICENSEE shall also pay
FHCRC a) [*] of all non-royalty consideration other than equity and [*] of all
non-royalty consideration which is equity received as a result of a sublicense
of LICENSED SERVICES, b) and [*] of all non-royalty consideration received as a
result of a sublicense of LICENSED PRODUCTS, all within thirty (30) days of
receipt of such consideration; provided, however, that to the extent the
non-royalty consideration received as a result of a sublicense is paid to
LICENSEE as funding for a specific research project, LICENSEE may at its option
elect to give FHCRC a negotiable promissory note in the principal amount of such
funding payable in twenty-four (24) months from the date the funding is received
by LICENSEE together with interest thereon at a per annum rate equal to the
prime rate of Bank of America, adjusted quarterly. Non-cash consideration
received by LICENSEE on account of a sublicense shall be appraised at LICENSEE's
expense using a third party acceptable to FHCRC. Non-cash consideration
includes, without limitation, debt, equity or other financial instruments, real
property, tangible personal property, rights and patents, patent applications,
trade secrets and licenses to such patents, patent applications and trade
secrets. Non-royalty sublicense income includes, without limitation, signing
fees, upfront fees, license issue fees, license maintenance fees, milestone
payments or other payments paid as consideration for the right to sell or
otherwise distribute LICENSED PRODUCTS or LICENSED SERVICES whether structured
as a sublicense, joint venture, collaboration or other arrangement. On sales
between LICENSEE and its AFFILIATES or authorized sublicensees for resale
royalties shall be paid on the resale.
5.3 Combined Products. In the event that any of the LICENSED PRODUCTS or
LICENSED SERVICES are used or sold by LICENSEE in combination as a single
product or service with one or more other product(s) or service(s) whose sale
and/or use are not within the scope of the this Agreement, and do not entail the
use of the LICENSED MONOCLONAL ANTIBODY, NET SALES from such sales and/or use
for purposes of calculating the amounts due under Section 5.2 above shall be
calculated by multiplying the NET SALES of that combination by the faction
A/(A+B), where A is the gross selling price of the LICENSED PRODUCT or LICENSED
SERVICE sold separately and B is the gross selling price of the other product or
service sold separately. In the event that no such separate sales or use are
made by LICENSEE, NET SALES for purposes of royalty determination shall be as
reasonably allocated by LICENSEE between such LICENSED PRODUCT or LICENSED
SERVICE and such other product or service, based upon their relative importance
and proprietary protection. It is
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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understood and agreed that LICENSEE intends to use LICENSED PRODUCTS and
LICENSED SERVICES in connection with products and services provided by LICENSEE
which do not entail the use of the LICENSED MONOCLONAL ANTIBODY, and that such
products and services shall be subject to this Section 5.3.
5.4 One Royalty. No more than one royalty payment shall be due with respect to a
sale of a particular LICENSED PRODUCT. No royalty shall be payable under this
Article 5 with respect to LICENSED PRODUCTS, distributed at no charge, for use
in research and/or development, in clinical, in clinical trials or as
promotional samples. When a LICENSED PRODUCT is used, sold or sublicensed as
part of LICENSED SERVICES, the royalty rate and other changes applicable to
LICENSED SERVICES shall apply and no royalty or charge shall be made for the
LICENSED PRODUCT in that case.
5.5 Equity Consideration. Within thirty days of the Amendment Effective Date
Xcyte Therapies, Inc. will issue Equity Consideration and deliver to FHCRC [*]
shares of common stock of Xcyte Therapies, Inc. These shares will be issued by
Xcyte Therapies, Inc. under a stock subscription agreement acceptable to FHCRC.
ARTICLE 6 - REPORTING AND ROYALTY PAYMENT TERMS
6.1 First Sales. LICENSEE shall report to FHCRC the date of first sale of
LICENSED PRODUCTS and or LICENSED SERVICES in each country within thirty (30)
days of occurrence.
6.2 Sales Reports and Royalty Payments. Commencing upon the First Commercial
Sale, LICENSEE shall submit to FHCRC within sixty (60) days after June 30 and
December 31 of each year during the Term, and upon the effective termination Of
this Agreement, reports for the preceding six (6) month period identifying the
amount of the LICENSED PRODUCTS or LICENSED SERVICES sold by LICENSEE, its
AFFILIATES and sublicensees in each country, the sales volume and NET SALES, and
the amount of royalty due to FHCRC together with payment of such royalty amount.
Such report shall be certified as correct by an officer of LICENSEE and shall
include a detailed listing of all deductions from NET SALES, sublicensee income
or from royalties as specified herein. If no royalties are due to FHCRC for any
reporting period, the written report shall so state. All payments due hereunder
shall be paid in United States Dollars. If any currency conversion shall be
required in connection with the payment of any royalties hereunder, such
conversion shall be made by using the exchange rate for the purchase of United
States Dollars reported by the Bank of America on the last business day of the
calendar quarter to which such royalty payments relate. If at any time legal
restrictions prevent the prompt remittance of any royalties owed on NET SALES in
any jurisdiction, LICENSEE shall notify FHCRC and make such payments by
depositing the amount thereof in local currency in a bank account or other
depository in such country in the name of FHCRC. All payments shall be without
deduction of exchange, collection or other charges. Without regard to or waiver
of any other remedies that may be available under this Agreement, any royalty
payments not made when due shall bear interest at the rate of [*] per annum,
compounded daily.
6.3 Withholding Taxes on Royalties. To the extent that any earned royalties due
FHCRC under this Agreement are subject to taxation where the taxes are imposed
on FHCRC, FHCRC agrees to bear such taxes. FHCRC hereby authorizes LICENSEE or
sublicensee to withhold such taxes from the payment which are otherwise payable
to FHCRC in accordance with this Agreement if LICENSEE or sublicensee is either
required to do so under the tax laws of the
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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country of sale or in the United States or directed to do so by an agency of
either such government. LICENSEE shall furnish FHCRC with relevant documentation
showing assessment of the taxes and the best available evidence of payment
whenever LICENSEE or sublicensee deducts such tax from any payments due FHCRC.
6.4 Confidentiality of Reports. All such reports shall be maintained in
confidence by FHCRC, except as required by law, including Public Laws 96-517 and
98-620.
ARTICLE 7 - RECORD KEEPING
7.1 Recordkeeping. LICENSEE shall maintain and require each sublicensee to
maintain complete and accurate books of account and records showing all sales of
LICENSED PRODUCTS and all NET SALES (including the amount of gross sales and
allowable deductions attributable to such sales). For purposes of verifying the
accuracy of the royalties paid by LICENSEE pursuant to this Agreement or
verifying performance of LICENSEE of any other obligation to FHCRC hereunder,
such books and records shall be open to inspection and copying, during usual
business hours, by an independent certified public accountant. Such accountant
shall not disclose to FHCRC any information other than information relating to
accuracy of reports and calculations of amounts due to FHCRC made under this
Agreement. In the event that any such inspection shows any underreporting and
underpayment by LICENSEE in excess of five percent (5%) for any twelve (12)
month period, then LICENSEE shall pay the cost of such examination. Such books
and records shall be maintained for at least three (3) years following the
reporting period to which the books and records relate.
ARTICLE 8 - INDEMNIFICATION AND INSURANCE
8.1 Indemnification. LICENSEE, including any successor to LICENSEE, shall, and
shall obligate its AFFILIATES or its sublicensees, if any, to indemnify, defend
and hold harmless FHCRC, its AFFILIATES and their respective directors,
officers, employees, agents and contractors (each an "Indemnitee") from and
against any and all liabilities, damages, losses, costs or expenses (including
reasonable attorneys' and professionals' fees and other expenses of litigation
and/or arbitration (a "Liability")) resulting from a claim, suit or proceeding
brought against an Indemnitee, arising out of or in connection with or resulting
from (i) any misrepresentation with regard to, or breach of, any of the
representations and warranties of LICENSEE set forth in Section 12 of this
Agreement, (ii) the use, development, manufacture, distribution, sublicensing or
sale of the LICENSED PRODUCTS or LICENSED SERVICES by LICENSEE or its AFFILIATES
or sublicensees except to the extent caused by the negligence or willful
misconduct of FHCRC, including without limitation any Liabilities resulting from
infringement of third party intellectual property rights, and (iii) any other
activities performed by LICENSEE or its AFFILIATES or sublicensees pursuant to
this Agreement.
8.2 FHCRC. FHCRC shall indemnify, defend and hold harmless LICENSEE and its
directors, officers and employees (each an "Indemnitee") from and against any
and all liabilities, damages, losses, costs or expenses (including reasonable
attorneys' and professionals' fees and other expenses of litigation and/or
arbitration) resulting from a claim, suit or proceeding brought against an
Indemnitee, arising out of or in connection with any misrepresentation with
regard to,
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or breach of, any of the representations and warranties of FHCRC set forth in
Section 12, except to the extent caused by the negligence or willful misconduct
of LICENSEE.
8.3 Insurance. In the event of any testing or use in human subjects of LICENSED
PRODUCTS, LICENSEE will have FHCRC named as an additional insured on LICENSEE'S
product liability insurance policies, with limits of at least [*]. Upon the
First Commercial Sale, LICENSEE will have FHCRC named as an additional insured
on LICENSEE's product liability insurance policies, with limits of [*]. Such
policies shall not be terminated without thirty (30) days prior written notice
to FHCRC. LICENSEE shall provide FHCRC with written evidence of the insurance
and a copy of the policy upon request.
8.4 Legal Action. In the event any legal action is commenced against LICENSEE
involving the LICENSED MONOCLONAL ANTIBODY, LICENSED CELL LINE, LICENSED
PRODUCTS and/or LICENSED SERVICES, whether or not FHCRC is named as a party to
the legal action, LICENSEE shall keep FHCRC or its attorney nominee fully
advised of the progress of the legal action and shall reimburse FHCRC for its
reasonable legal costs (including attorney's fees) incurred as a result of
FHCRC's employees or agents being called as witnesses therein or asked to
testify for or consult with LICENSEE in connection therewith. FHCRC agrees to
cooperate with LICENSEE, to the extent reasonably possible, in any legal action
brought pursuant to this Article 8.
ARTICLE 9 - DISPUTE RESOLUTION
9.1 The parties do not favor litigation. Therefore, unless a party is entitled
to injunctive relief, as ultimately determined by a court of competent
jurisdiction, because (i) the party is exposed to irreversible losses unless the
conduct is enjoined, (ii) there is no adequate remedy in the form of
compensatory damages, and (iii) there is a substantial likelihood that the party
will prevail on the merits, the parties agree to submit all disputes relating to
the interpretation, enforcement, or breach of this Agreement to non-binding
mediation before a mediator acceptable to both parties in accordance with its
Commercial Mediation Rules or such alternative mediator as the parties may
approve in writing.
9.2 If the parties are unable to resolve their differences through mediation as
provided in this Article 14 or if the matter is not subject to mediation under
this Article 14, either party may initiate a lawsuit to resolve the dispute.
ARTICLE 10 - CONFIDENTIALITY
10.1 Definition of Confidential Information. It is contemplated that in the
course of the performance of this Agreement each party may, from time to time,
disclose proprietary and confidential information to the other ("Confidential
Information"). Confidential Information shall include all disclosures made
hereunder or under previous confidentiality agreements between the Parties in
writing and identified as being "Confidential," or if disclosed orally, which
are reduced to writing within thirty (30) days of oral disclosure and clearly
identified as being "Confidential." FHCRC and LICENSEE agree that this Agreement
shall supersede all
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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previous confidentiality agreements between the parties and all disclosures made
under any previous confidentiality agreements shall be subject to the terms of
this Section 10.
10.2 Nondisclosure of Confidential Information. Except to the extent expressly
authorized by this Agreement or otherwise agreed to in writing, during the term
of this Agreement and for a period of five (5) years following the termination
of this Agreement, each party shall take such reasonable measures to protect the
secrecy of and avoid disclosure or use of such Confidential Information of the
other party in order to prevent it from falling into the public domain or the
possession of any person other than those persons authorized under this
Agreement to have any such information. Such measures shall include, but not be
limited to, the highest degree of care the receiving party takes to protect its
own proprietary and confidential information of a similar nature, which shall be
no less than reasonable care. Neither party shall disclose or permit disclosure
of any Confidential Information of the other party to third parties or to
employees of the party receiving Confidential Information, other than directors,
officers, employees, consultants and agents who are required to have the
information in order to carry out the terms of this Agreement. Each party shall
notify the other in writing of any actual or suspected misuse, misappropriation
or unauthorized disclosure of the other party's Confidential Information that
may come to such party's attention. Not withstanding the foregoing, Confidential
Information from FHCRC shall include but not be limited to devices, cell lines,
monoclonal antibodies, methods, processes, data regarding testing and
experiments, drawings, documentation, patent applications and product
development plans, is FHCRC's confidential, proprietary, trade secret
information.
10.3 Exceptions. The following information shall not be considered Confidential
Information:
(a) information which was already known to the receiving party,
other than under an obligation of confidentiality to the
disclosing party, at the time of disclosure by the other party
as shown by the receiving parties written records;
(b) information which was generally available to the public or
otherwise part of the public domain at the time of its
disclosure to the receiving party;
(c) information which becomes generally available to the public or
otherwise part of the public domain after its disclosure and
other than through any act or omission of the receiving party in
breach of this Agreement;
(d) information which was disclosed to the receiving party, other
than under an obligation of confidentiality, by a third party
who had no obligation to the disclosing party not to disclose
such information; or
(e) information which was developed independently without reference
to Confidential Information received from the other party
hereunder as evidenced by the receiving party's own written
records.
10.4 Permitted Usage. Notwithstanding the provisions of Section 10.1 above, the
receiving party may use or disclose Confidential Information of the disclosing
party in connection with the
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exercise of its rights hereunder (including commercialization and/or
sublicensing) or the fulfillment of its obligations and/or duties hereunder and
in filing for, prosecuting or maintaining any proprietary rights, prosecuting or
defending litigation, complying with applicable governmental regulations and/or
submitting information to tax or other governmental authorities; provided that
if the receiving party is required by law to make any public disclosures of
Confidential Information of the disclosing party, to the extent it may legally
do so, it shall give reasonable advance notice to the disclosing party of such
disclosure and shall use its reasonable efforts to secure confidential treatment
of Confidential Information prior to its disclosure (whether through protective
orders or otherwise); and, provided, further, that to the extent that the
receiving party is disclosing information to a third party for commercialization
or sublicensing that the third party has agreed to terms at least as restrictive
as the terms of this Article 10 and may not further disclose the information to
any third party and FHCRC has been provided with a copy of the agreement.
ARTICLE 11 - TERMINATION OF AGREEMENT
11.1 Termination on Payment Default. At FHCRC's option, FHCRC may terminate this
Agreement effective thirty (30) days after giving written notice in the event
LICENSEE fails to pay any royalties or other amounts owed under this Agreement
when due. During the thirty (30) day period after written notice of payment
default, LICENSEE has the right to cure any payment default and prevent
termination under this Section 11.1.
11.2 Termination on Other Defaults. This Agreement may be terminated by either
party upon a material breach by the other party other than a payment default
which is governed by Section 11.1, effective ninety (90) days after giving
written notice to the breaching party of such termination under this Section and
specifying such breach, unless the breach is cured or shown to be non-existent
within the ninety (90) day period, in which case the Agreement will remain in
effect.
11.3 Termination on Bankruptcy or Insolvency. Subject to any provisions of the
federal bankruptcy laws limiting rights of termination, FHCRC may terminate this
Agreement if LICENSEE files for protection under federal bankruptcy laws,
becomes insolvent, makes an assignment for the benefit of creditors, appoints or
suffers appointment of a receiver or trustee over its property, files a petition
under any bankruptcy or insolvency act or has any such petition filed against it
or files for dissolution.
11.4 Termination by LICENSEE. LICENSEE may terminate this Agreement in its
entirety for any reason or no reason with thirty (30) days written notice to
FHCRC.
11.5 Effect of Termination. Upon termination of this Agreement, each party will
turn over to the other party all Confidential Information of such other party
and all documents or data storage media containing any such Confidential
Information and any and all copies thereof and will delete all such Confidential
Information from its documents or data storage media. In addition, upon
termination of this Agreement, LICENSEE shall return to FHCRC or destroy, at
FHCRC's option and expense all of the LICENSED CELL LINE and all LICENSED
MONOCLONAL ANTIBODY in possession of LICENSEE or any AFFILIATE sublicensee or
other third party
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who has received the LICENSED CELL LINE or LICENSED MONOCLONAL ANTIBODY from
LICENSEE provided that LICENSEE shall be entitled to sell LICENSED PRODUCT as
provided in Section 11.7 of this Agreement. Upon termination of this Agreement
the Licenses shall terminate. Neither party shall be able to claim from the
other party any damages or compensation for loses or expenses resulting solely
from termination of this Agreement as permitted under this Section 11.
11.6 Effect of Termination on Sublicensees. Any sublicenses granted by LICENSEE
under this Agreement shall provide for termination or assignment to FHCRC at
FHCRC's sole discretion, of LICENSEE's interests therein upon termination of
this Agreement for any reason.
11.7 Sale of Products on Termination. In the event of any early termination of
this Agreement in accordance with this Article 11, for a period of six (6)
months after termination LICENSEE shall have the right to sell all LICENSED
PRODUCTS on hand at the time of such termination, provided that LICENSEE shall
make all payments with respect thereto to FHCRC in accordance with this
Agreement.
11.8 Final Report. Upon termination, a final report shall promptly be submitted
in accordance with the provisions of Section 5.4, together with any royalty
payments and unreimbursed patent expenses due to FHCRC.
11.9 Survival of Rights and Duties. Rights and duties hereunder which by their
terms or nature survive the termination or expiration of this Agreement shall so
survive such termination or expiration, including without limitation LICENSEE's
duties under Articles 5 through 11 and 15.
ARTICLE 12 - REPRESENTATIONS AND COVENANTS
12.1 LICENSEE Representations and Warranties. LICENSEE represents and warrants
to FHCRC that it has obtained and will at all times during the Term hold and
comply with all licenses, permits and authorizations necessary to LICENSEE's
complete and timely performance of its obligations under this Agreement which
are required under any applicable statutes, laws, ordinances, rules and
regulations of the United States as well as those of all applicable foreign
governmental bodies, agencies and subdivisions, having, asserting or claiming
jurisdiction over LICENSEE or LICENSEE's performance of the terms of this
Agreement. In particular, LICENSEE:
(a) will be responsible for obtaining all necessary United States Food
and Drug Administration approvals and all approvals required by similar
governmental bodies or agencies of all applicable foreign countries; and
(b) understands and acknowledges that the transfer of certain
commodities and technical data is subject to United States laws and
regulations controlling the export of such commodities and technical
data, including all Export Administration Regulations of the United
States Department of Commerce. These laws and regulations, among other
things, prohibit or require a license for the export of certain types of
technical data to certain specified countries. LICENSEE hereby agrees
and gives written assurance that it
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will comply with all United States laws and regulations controlling the
export of commodities and technical data, that it will be solely
responsible for any violation of such by LICENSEE or its AFFILIATES or
sublicensees, and that it will defend and hold FHCRC harmless in the
event of any legal action of any nature occasioned by such violation.
12.2 FHCRC Representations and Covenants. FHCRC warrants and represents to
LICENSEE that: (i) it has and will maintain the full right and authority to
enter into this Agreement and grant the rights and licenses granted herein; (ii)
it has not previously granted and will not grant any rights or licenses in
conflict with the rights and licenses granted herein; (iii) to its knowledge no
action, suit or claim has been initiated or threatened with respect to the
LICENSED MATERIALS that would call into question FHCRC's right to enter into and
perform its obligations under this Agreement;
12.3 Disclaimer of Warranty. To Licensee, its AFFILIATES, its sublicensees and
customers or otherwise, express or implied, oral or written, arising by law,
course of dealing, course of performance usage of trade or otherwise, with
respect to the LICENSED CELL LINE, LICENSED MONOCLONAL ANTIBODY, LICENSED
PRODUCT, LICENSED TECHNICAL INFORMATION, including without limitation all
warranties as to the condition, manufacture, sale, use, operation, design,
quality, capacity, latent defects, compliance with any law, ordinance,
regulation, rule, contract or specification, "merchantability," fitness for any
particular purpose, and all other qualities and characteristics whatsoever.
FHCRC neither assumes nor authorizes LICENSEE or any person to assume for FHCRC
any liability in connection with the manufacture, sale or use of any LICENSED
PRODUCT. In no event shall FHCRC be liable for any consequential, incidental or
special damages or expenses (including without limitation labor, transportation,
loss of use, loss of profits and damage to persons or property) even if FHCRC
has been advised of the possibility thereof.
ARTICLE 13 - COMMERCIALLY REASONABLE EFFORTS
13.1 Reasonable Efforts. LICENSEE shall use reasonable effort to introduce the
LICENSED PRODUCTS into the commercial market within five (5) years of the
Effective Date, consistent with sound and reasonable business practices and
judgment, and thereafter endeavor to keep LICENSED PRODUCTS reasonably available
to the public.
ARTICLE 14 - NOTICES
14.1 Notices. All communications, including payments, notices, demands or
requests required or permitted to be given hereunder, shall be given in writing
and shall be:
(a) personally delivered;
(b) sent by facsimile or other electronic means of transmitting
written documents; or
(c) sent to the parties at their respective addresses indicated
herein by registered or certified U.S. mail, return receipt
requested and postage prepaid, or by private overnight
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mail courier service. The respective addresses to be used for all such
payments, notices, demands or requests are as follows:
If to FHCRC: Xxxx Xxxxxxxxxx Cancer Research Center
0000 Xxxxxxxx Xxx. X., X0X-000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx Beer,
Senior Licensing Associate
Facsimile: (000) 000-0000
With copies to: Xxxxxxx X. Xxxxxxxx, Esq.
Xxxx Xxxxxxxxxx Cancer Research Center
0000 Xxxxxxxx Xxx. X., X0X-000
Xxxxxxx, Xxxxxxxxxx 00000
Facsimile: (000) 000-0000
If to LICENSEE: Xcyte Therapies, Inc.
0000 Xxxxxxx Xxx Xxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Business Development
Facsimile: (000) 000-0000
With copies to: Venture Law Group
0000 Xxxxxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxxxx
Facsimile: (000) 000-0000
If personally delivered, such communication shall be deemed delivered upon
actual receipt. If electronically transmitted pursuant to this section, such
communication shall be deemed delivered when transmitted. If sent by overnight
courier pursuant to this section, such communication shall be deemed delivered
within twenty-four hours of deposit with such courier. If sent by U.S. mail
pursuant to this section, such communications shall be deemed delivered as of
the date of delivery indicated on the receipt issued by the relevant postal
service, or, if the addressee fails or refuses to accept delivery, as of the
date of such failure or refusal. Any party to this Agreement may change their
address for the purposes of this Agreement by giving notice in accordance with
this Section.
ARTICLE 15 - MISCELLANEOUS
15.1 Governing Law. The rights and obligations of the parties under this
Agreement shall be governed by and construed in accordance with the laws of the
State of Washington.
15.2 Amendments. This Agreement may not be amended except by an instrument in
writing signed by both parties.
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15.3 Assignability. The Agreement shall be binding on the parties hereto and
upon their respective heirs, administrators, successors and assigns. This
Agreement may not be assigned by LICENSEE or by operation of law without the
prior written consent of FHCRC, which consent shall not be unreasonably
withheld; except either party may assign this Agreement, without such consent,
to (i) an AFFILIATE of such party; or (ii) an entity that acquires all or
substantially all of the business or assets of such party to which this
Agreement pertains, whether by merger, reorganization, acquisition, sale or
otherwise, and that agrees in writing to be strictly bound by the terms and
conditions of this Agreement.
15.4 Non-Profit Status. LICENSEE acknowledges that FHCRC is a non-profit
organization qualifying for and holding the status of an exempt organization
under Section 50l(c)(3) of the United States Internal Revenue Code. If the
Internal Revenue Service determines, or a determination by FHCRC based on advice
of legal or tax counsel is reasonably made, that any part or all of this
Agreement will jeopardize FHCRC's Section 501(c)(3) status, the parties agree to
meet and confer in good faith to amend this Agreement to the extent necessary to
satisfy Internal Revenue Service requirements for retention of FHCRC's Section
50l(c)(3) status. If FHCRC and LICENSEE cannot agree within 30 days after
commencing negotiations regarding the amendments to be made to this Agreement in
order for FHCRC to retain its Section 501(c)(3) status, FHCRC may terminate this
Agreement effective upon giving written notice to LICENSEE of termination under
this Section 10.
15.5 Conflicts with Grants. LICENSEE understands and acknowledges that
agreements between FHCRC and agencies of the United States Government funding
FHCRC's programs may contain clauses granting patent and/or other rights to the
agencies or the U.S. Government; LICENSEE agrees that the rights granted to it
under this Agreement shall be subject to any rights of the agencies and the U.S.
Government. If a conflict arises, the provisions of any U.S. Government agency
funding agreement and/or regulation shall prevail over any conflicting
provisions of this Agreement and FHCRC will have no liability to LICENSEE as a
result of such conflict. If such a conflict arises or is reasonably anticipated,
FHCRC will promptly give notice to LICENSEE of the nature of the conflict and
copies of any correspondence relating thereto in accordance with Section 14.1.
15.6 Use of Name. Neither party shall use the name of the other party or reveal
the terms of this Agreement in any publicity or advertising without the prior
written approval of the other party, except that (i) either party may use the
text of a written statement approved in advance by both parties without further
approval; (ii) either party shall have the right to identify the other party and
to disclose the terms of this Agreement as required by applicable securities
laws or other applicable law or regulation; and (iii) either party may disclose
that a licensing relationship exists between the parties and may disclose the
name of the other party in that context.
15.7 Written Notices. All letters, documents, or other materials of a written or
physical nature, required by or relating to this Agreement shall be in English
and sent to the party at the address given in Article 14.
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15.8 Independent Parties. The parties to this Agreement are independent
contractors and not agent of the other. This Agreement shall not constitute a
partnership or joint venture, and neither party may be bound by the other to any
contract, arrangement or understanding except as specifically stated herein.
15.9 Enforceability. Should a court of competent jurisdiction later consider any
provision of this Agreement to be invalid, illegal, or unenforceable, it shall
be considered severed from this Agreement. All other provisions, rights and
obligations shall continue without regard to the severed provision, provided
that the remaining provisions of this Agreement are in accord with the intention
of the parties.
15.10 Actions. In the event any party to this Agreement commences any action or
proceeding, including an appeal of an action or proceeding, against the other,
or otherwise retains an attorney, by reason of any breach or claimed breach of
any provision of this Agreement, or to seek a judicial declaration of rights
hereunder or judicial or equitable relief, the prevailing party in such action
or proceeding shall be entitled to recover its reasonable attorneys' fees and
costs. At the option of FHCRC, venue of any such legal or equitable action shall
lie in Seattle, Washington. LICENSEE hereby submits to the jurisdiction of the
Federal District Court of Western Washington located in Seattle, Washington, and
hereby agrees to accept service of process by certified mail, return receipt
requested, effective upon delivery to LICENSEE.
15.11 Force Majeure. LICENSEE and FHCRC shall not be liable for loss, damage,
detention or delay resulting from any cause whatsoever beyond its reasonable
control or resulting from a force xxxxxx, including, without limitation, fire,
flood, strike, lockout, civil or military authority, insurrection, war, embargo,
container or transportation shortage or delay of suppliers due to such causes,
and delivery dates shall be extended to the extent of any delays resulting from
the foregoing or similar causes. The party so affected shall give prompt notice
to the other party of such cause, and shall take whatever reasonable steps are
necessary to relieve the effect of such cause as rapidly as reasonably possible.
The party giving such notice shall thereupon be excused from such of its
obligations hereunder as it is thereby disabled from performing for so long as
it is so disabled and for thirty (30) days thereafter, whichever is longer;
provided, however, that such affected party commences and continues to take
reasonable and diligent actions to cure such cause.
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IN WITNESS WHEREOF, the parties have executed this Agreement through
duly authorized representatives as of the date first above written.
XXXX XXXXXXXXXX CANCER RESEARCH CENTER
By /s/ Xxxxxxx X. Xxxxxxxx
-------------------------------
Printed
Name Xxxxxxx X Xxxxxxxx
Title, V.P. and General Counsel
XCYTE THERAPIES INC.
By /s/ Xxxxxx Xxx Xxxxxxxx
-------------------------------
Printed
Name Xxxxxx Xxx Xxxxxxxx
-----------------------------
Title President & CEO
----------------------------
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