LICENSE AGREEMENT
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of
1934.
Exhibit
10.1
This
License Agreement (the “Agreement”) takes effect as of March 29, 2007 (the
“Effective Date”) between Immunocept LLC (“Licensor”), with offices at 0000
Xxxxxxxxxx Xxxxxx, Xxxxxx, XX 00000, and Xxxxxx Systems, Inc. (“Xxxxxx” or
“Licensee”), with offices at 0000 Xxxxxx Xxxxxx, Xxxxx 0000, Xxxxxxx, XX 00000.
BACKGROUND
A. WHEREAS,
Xxxxxx
wishes to obtain a license from Licensor under certain Patent Rights (as defined
below) owned by Licensor and of which Xxxxx X. Xxxxxx M.D. (“Xx. Xxxxxx”) is a
co-inventor.
B. WHEREAS,
Licensor
is willing to grant a license to Xxxxxx under the Patent Rights on the terms
and
conditions set forth below.
NOW,
THEREFORE, in consideration of the foregoing and the covenants and premises
contained herein, the parties therefore agree as follows:
ARTICLE
1
DEFINITIONS
As
used
in this Agreement, the following terms have the meaning set forth in this
Article 1.
1.1 “Affiliate”
means
any corporation or other entity that is directly or indirectly controlling,
controlled by or under the common control with a party hereto. For the purpose
of this Agreement, “control” includes the direct or indirect ownership of at
least fifty percent (50%) of the outstanding shares or other voting rights
of
the subject entity to elect directors or, in the case of an entity that is
not a
corporation, for the election of the corresponding managing
authority.
1.2 “Arms
Length Royalty”
means
a
patent royalty paid to an unrelated party. Specifically, a royalty is not an
“Arms Length Royalty” if it is paid by a Licensed Party (which for purposes of
this definition, includes a Sublicensee) to either (a) another Licensed Party,
or to any person who is (or was, at the time the transaction was arranged,
negotiated, or agreed, or was at the time of the invention of the relevant
patent) an officer, director, employee, or owner of more than 5% of the equity
ownership of a Licensed Party; or (b) an Affiliate of any party described in
clause (a); or (c) a party with which the Licensed Party or any party described
in clauses (a) or (b) has some other relationship relevant to the development
or
commercialization of Products or Other Products, whether family or commercial,
such as joint venture partners.
1
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
1.3 “Arms
Length Sale”
means
a
sale of a Product or an Other Product to an unrelated party. Leasing or renting
a Product or an Other Product shall be deemed a sale for purpose of this
definition and for determining royalties payable under this Agreement. Any
Recovery for carrying out a method covered by a Valid Claim shall be deemed
a
sale for purpose of this definition and for determining royalties payable under
this Agreement. Specifically, a sale, including leasing or renting, is not
an
“Arms Length Sale” if it is a sale by a Licensed Party (which, for purposes of
this definition, includes a Sublicensee) to either (a) another Licensed Party,
or to any person who is (or was, at the time the transaction was arranged,
negotiated, or agreed) an officer, director, employee, or owner of more than
5%
of the equity ownership of a Licensed Party, (b) an Affiliate of any party
described in clause (a), or (c) a party with which the Licensed Party or any
party described in clauses (a) or (b) has some other relationship relevant
to
the development or commercialization of Products or Other Products, whether
family or commercial, such as joint venture partners and including without
limitation any Affiliate or Sublicensee, unless in any such event it is consumed
by such transferee.
1.4 “Data”
shall
have the meaning set forth in Section 2.2.
1.5 “Net
Sales”
means
gross invoiced amounts due to Xxxxxx, its Affiliates or Sublicensees as Recovery
on Arms Length Sales of Products or Other Products less: (1) ordinary and
customary trade discounts actually allowed; (2) credits, rebates,
allowances for uncollectible amounts and adjustments for rejections, recalls
and
returns (including, but not limited to, wholesaler and retailer returns);
(3) freight, postage, insurance and duties paid for and separately
identified on the invoice or other documentation maintained in the ordinary
course of business, (4) excise taxes, other consumption taxes, customs
duties and compulsory payments to governmental authorities actually paid and
separately identified on the invoice or other documentation maintained in the
ordinary course of business, and (5) allowances for actual uncollectible
accounts determined in accordance with U.S. generally accepted accounting
practices.
1.6 “Licensed
Party”
means
Xxxxxx and Xxxxxx Affiliates.
1.7 “Other
Product”
means
any unit of product which, if manufactured, used or sold in the United States,
would meet the definition of Product at the time of such manufacture, use,
or
sale, but which does not meet such definition in a country where actually
manufactured, used or sold due to the fact that Patent Rights were not pursued
or have not issued in such country(ies). For the avoidance of doubt by the
way
of example (a) a unit of Product manufactured in a country in which Patent
Rights were not pursued or have not issued, but sold in a country in which
Patent Rights covering such sale are issued (whether or not used in such
country) would be a Product and not an Other Product; (b) a unit of Product
manufactured in a country in which Patent Rights were not pursued or have not
issued, but sold in a country in which Patent Rights covering such Product’s use
or sale are issued would be a Product and not an Other Product; and (c) a unit
of Product manufactured in a country in which Patent Rights covering such
manufacture were pursued or have issued, but sold and used in a country in
which
Patent Rights were not pursued or issued would be a Product and not an Other
Product.
2
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
1.8 “Patent
Rights”
means
all of Licensor’s right, title and interest in:
1.8.1 all
patents and patent applications covering inventions relating to blood therapy
devices and systems for treatment of toxic and inflammatory mediator related
diseases or organ failures which are owned or controlled by Licensor as of
the
Effective Date or within one year thereafter, including without limitation
those
listed in Exhibit A hereto (the “Patents”);
1.8.2 all
divisionals, continuations, continuations-in-part (CIPs), and foreign
counterparts of the Patents, and
1.8.3 all
patents issuing on any preceding applications, and any re-issues,
re-examinations or extensions of any kind and supplementary protection
certificates with respect to any of the foregoing.
For
the avoidance of doubt, continuations-in-part shall include any
continuations-in-part resulting from or relating to the services
to be
performed under that certain Service Advisory Agreement to be entered
into
by and between Xxxxxx and Xxxxx X. Xxxxxx, MD of even date herewith
(the
“Xxxxxx Service Agreement”).
|
1.9 “Product”
means
a
product the manufacture, sale or use of which would, but for the license granted
hereunder, infringe a Valid Claim of a Patent Right in a country where either
its manufacture, sale or use occurs.
1.10 “Recovery”
means
any and all consideration received by a Licensed Party or a Sublicensee for
an
Arms Length Sale of a Product or an Other Product or for carrying out a method
covered by a Valid Claim, including cash, revenue, and non-cash
consideration.
1.11 “Sublicensee”
means
any third party who is not an Affiliate and to whom Xxxxxx, or an Affiliate
of
Xxxxxx, grants a sublicense under the Patent Rights to make, have made, use,
have used, sell, offer for sale, have sold, import or have imported Products
and/or Other Products.
1.12 “Valid
Claim”
means
a
claim of an issued and unexpired patent included within the Patent Rights which
has not been held invalid in a final decision of a court or forum of competent
jurisdiction from which no appeal may be taken, and which has not been
disclaimed or admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise.
3
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
2
LICENSE
2.1 Grant.
(a)
Licensor hereby grants Xxxxxx an exclusive worldwide license under the Patent
Rights and any and all related proprietary information, to research, develop,
make, import, have made, use, offer for sale, sell and have sold Products and
Other Products, including a license to research, develop, make, import, have
made, use, offer for sale, sell and have sold Products and Other Products that
if used together with other products in a hemofiltration system, a blood
filtration circuit, or method of treating patients under those systems that
would infringe the Patent Rights but for this license.
(b)
The
license granted under Section 2.1 includes the right to grant sublicenses
consistent with the terms of this Agreement, specifically requiring the payment
by the Sublicensee of royalties at least as great as the royalties that will
be
payable to Licensor hereunder on account of sales by the Sublicensee. Provided
that, such sublicenses must (a) expressly permit such sublicense to either
terminate (without notice or further action) or to be assigned to Licensor
or
its assigns (without notice or further action) in the event of termination
of
this Agreement; and (c) expressly permit Licensor to inspect Sublicensee's
books
and records in accordance with the terms of Section 4.4. The right to grant
sublicenses is also conditioned on Xxxxxx’ provision of a copy of any such
sublicense to Licensor within ten (10) days of its execution.
(c)
The
license granted herein includes a fully paid, perpetual, irrevocable license
under the Patent Rights with respect to all actions of Xxxxxx occurring prior
to
the Effective Date of this Agreement. This Section 2.1(c) shall survive any
termination of this Agreement.
2.2 Related
Information.
Within
thirty (30) days of the Effective Date, Licensor shall also provide to Xxxxxx
copies of all data and information in its possession relating to large pore
hemofiltration for use in critical care (“Data”), including all data and
information relating to preclinical studies performed by Licensor. Xxxxxx shall
be entitled to use such information in connection with the research,
development, regulatory approval, clinical development and commercialization
of
Products and related projects.
2.3 Additional
Research.
In
consideration of the rights granted hereunder, Xxxxxx agrees to perform, or
have
performed, certain product development and clinical research relating to sepsis
applications of hemofiltration products as follows: (a) the work shall be
conducted by Xxxxxx in accordance with a research plan, timeline, budget, and
clinical protocol as mutually agreed by Xx. Xxxxxx and Xxxxxx promptly following
the Effective Date, (b) the research plan may include the development of
clinical grade filters having mutually agreed specifications, (c) the total
budget for such product development and clinical research efforts shall not
be
required to exceed [*] unless otherwise agreed by Xxxxxx, which amount shall
not
include any amounts paid to Xx. Xxxxxx pursuant to the Xxxxxx Service Agreement
nor the cost of up to fifty (50) clinical grade filters which shall be provided
by Xxxxxx at Xxxxxx’ expense for use with up to twenty (20) patients to be
enrolled in the mutually agreed clinical study. Xxxxxx shall own all results
of
any such work, provided that Xx. Xxxxxx shall be permitted to use such results
in pursuing further clinical studies as reasonably agreed in writing by Xxxxxx.
Xx. Xxxxxx’x efforts related to such research shall be provided pursuant to a
Service Advisory Agreement between Xx. Xxxxxx and Xxxxxx of even date herewith.
4
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
2.4 Fair
Dealing.
Xxxxxx
agrees to act in good faith in the manufacture, distribution and pricing of
Products and Other Products and any related systems or components sold by Xxxxxx
or its Affiliates in conjunction with Products or Other Products so as to not
intentionally seek to reduce royalties payable to Licensor
hereunder.
ARTICLE
3
CONSIDERATION
3.1 License
Fees.
On the
Effective Date, Xxxxxx shall pay Licensor an initial non-refundable license
fee
of [*]. In addition, on the Effective Date Xxxxxx shall xxxxx warrants to
Licensor for the purchase of 225,000 shares of Xxxxxx Common Stock according
to
the form of warrant attached as Exhibit B hereto.
Additionally,
Xxxxxx shall make the following cash payments to Licensor during the term of
this Agreement:
3.1.1 [*]
on or
before January 1, 2008;
3.1.2 [*]
on or
before January 1, 2009;
3.1.3 [*]
on or
before January 1, 2010;
3.1.4 [*]
within thirty (30) days of the issuance of the first European patent [*];
3.1.5 [*]
within thirty (30) days of the issuance of the first European patent included
in
the Patent Rights [*];
3.1.6 [*]
within thirty (30) days of the first issuance following the Effective Date
of a
U. S. patent [*];
3.1.7 [*]
within thirty (30) days of the first issuance following the Effective Date
of a
U. S. patent included in the Patent Rights[*].
Each
such
payment shall be due only once and only if the relevant event occurs during
the
term of this Agreement.
5
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
3.2 Royalties.
3.2.1 Percentage.
During
the relevant royalty term as defined in Section 3.2.5 below, Xxxxxx shall pay
Licensor a royalty of [*%)] on Net Sales of Products and [*%]) on Net Sales
of
Other Products.
3.2.2 One
Royalty.
No more
than one royalty payment shall be due with respect to Net Sales of a particular
Product or Other Product. No multiple royalties shall be payable because a
Product or Other Product, or its manufacture, sale or use, is covered by more
than one Valid Claim.
3.2.3 Reductions.
If
Xxxxxx is also required to pay any Arms Length Royalties with respect to Net
Sales of a Product under agreements for rights to patent rights covering the
relevant Product, Xxxxxx shall be entitled to credit 50% of any such payments
against royalties due hereunder, subject to a maximum reduction of [*]% of
the
royalties otherwise due (i.e., a minimum royalty of [*]% on Net Sales of
Products shall apply). If Xxxxxx is also required to pay Arms Length Royalties
with respect to Net Sales of an Other Product under agreements for rights to
patent rights covering the relevant Other Product, Xxxxxx shall be entitled
to
credit 50% of any such payments against royalties due hereunder, with no maximum
reduction of the royalties otherwise due.
3.2.4 Non-commercial
Transactions.
In the
event that a Product or Other Product is provided by a Licensed Party and
actually used for medical purposes, but no Arms Length Sale has taken place,
then Net Sales with respect to such Product or Other Product shall be determined
based upon the price generally charged the trade in Arms Length Sales by the
Licensee, its Affiliates or Sublicensees, as relevant, at that time. As used
herein “price generally charged the trade” shall be determined by obtaining the
average of the net sales price in Arms Length Sales over the prior twelve (12)
months (or so long as sales have been made, if fewer than twelve (12) months’
information is then unavailable); provided that if no such comparable net sales
price is available, it shall be based upon a commercially reasonable price
determined by mutual written agreement of the parties. For clarity and
notwithstanding the foregoing, provision of Products or Other Products at no
cost for use in development activities, including clinical trials, or at no
cost
for promotional purposes in a manner reasonably consistent with industry
practices, shall not be subject to the foregoing provision. Xxxxxx agrees that
it will not sell Products or Other Products in any manner other than to
Affiliates or Sublicensees, or in an Arms Length Sale, unless otherwise agreed
by Licensor, such agreement to not be unreasonably withheld.
3.2.5 Royalty
Term.
Royalties due under this Article 3 shall be payable on a country-by-country
and
product-by-product basis for Products until the expiration of the last-to-expire
Valid Claim covering such Product in such country and, with respect to Other
Products, until the expiration of the last-to-expire Valid Claim of relevant
Patent Rights in the United States.
6
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
4
PAYMENTS;
REPORTS AND RECORDS
4.1 Payments;
Currency.
Xxxxxx
shall make all payments due under this Agreement by wire transfer in United
States dollars in immediately available funds to an account designated by
Licensor. If any currency conversion is required in connection with the payment
of any royalties under this Agreement, the conversion shall be made by using
the
exchange rate for the purchase of U.S. dollars reported by The Wall Street
Journal on the last business day of the calendar quarter to which such royalty
payments relate.
4.2 Taxes.
Royalty
amounts required to be paid to Licensor pursuant to this Agreement may be paid
with deduction for withholding for or on account of any taxes (other than taxes
imposed on or measured by net income) or similar governmental charge imposed
by
a jurisdiction other than the United States (“Withholding Taxes”); provided
that, Xxxxxx provides Licensor with advance notice of any expected Withholding
Taxes which may reduce the amounts actually received by Licensor hereunder.
At
Licensor’s request, Xxxxxx shall provide Licensor a certificate evidencing
payment of any Withholding Taxes hereunder and shall reasonably assist Licensor
to obtain the benefit of any applicable tax treaty or law.
4.3 Royalty
Reports and Payments.
After
the first commercial sale of a Product or Other Product, Xxxxxx shall make
quarterly written reports to Licensor within forty-five (45) days after the
end
of each calendar quarter, stating in each such report, by country, the number,
description, and aggregate Net Sales of each Product and Other Product sold
(whether by Xxxxxx, its Affiliates, or its Sublicensees) and sublicensing
royalties received during the calendar quarter, including detail reasonably
necessary to substantiate the calculation of royalties. Such information shall
permit Licensor to calculate royalties based upon direct sales by Arbios and
each of its Affiliates and Sublicensees, and any distributors and resellers
to
whom sales that are not Arms Length Sales are made. Concurrently with the making
of such reports, Xxxxxx shall pay Licensor the payments specified in
Section 3.2.
4.4 Records;
Inspection.
Xxxxxx
shall keep complete, true and accurate books of account and records for the
purpose of determining the royalty amounts payable under this Agreement. Such
books and records shall be kept at the principal place of business of Xxxxxx
for
at least three (3) years following the end of the calendar quarter to which
they
pertain and will be open for inspection during such period by a representative
of Licensor for the purpose of verifying the royalty reports and payments.
Such
inspections shall be made during ordinary business hours. The representative
may
be obliged to execute a reasonable confidentiality agreement prior to commencing
any such inspection. Inspections conducted under this Section 4.4 shall be
at Licensor’s expense, unless an underpayment exceeding five percent (5%) of the
amount stated for the period covered by the inspection is identified, in which
case all costs relating to the inspection and any unpaid amounts will be paid
by
Xxxxxx.
Any
amounts not paid when due (for any reason) shall bear interest at the lesser
of
one percent (1%) per month or the maximum interest allowable under the
law.
7
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
5
DUE
DILIGENCE
5.1 Diligence
Efforts.
Xxxxxx
shall use commercially reasonable efforts to develop and bring one or more
Products to market through a diligent program for the exploitation of the Patent
Rights. In
addition, Xxxxxx shall:
a.
|
Submit
to the United States Food and Drug Administration (“FDA”) by
[*]
plans for a pivotal clinical study designed for a Product covered
by the
‘040 family of Patents for liver failure (an “[*] Study”) and, within
thirty (30) days of such submission, deliver to Licensor a certificate
stating the product and/or method that is the subject of the study
is a
Product covered by this License;
|
b.
|
Within
90 days after receiving FDA permission to begin an [*] Study, recruit
at
least 4 sites for such study, defined as Principal Investigators
having
been identified and contracts being under negotiation;
|
c.
|
Bring
a commercial Product to market no later than [*]; and
|
d.
|
Obtain
aggregate cash equity or debt investments, funding from corporate
partners, sale of assets, or grants, of at least the following amounts
on
or before the designated dates (amounts are cumulative, not additive):
|
i.
|
$[*]
by [*];
|
ii.
|
$[*]
by [*]; and
|
iii.
|
$[*]
by [*].
|
Material
failure by Xxxxxx to meet any of the above milestones shall be deemed a material
breach of this Agreement and shall give Licensor the right to terminate this
Agreement pursuant to the provisions of Section 9.3 hereof. The certificate
delivered by Xxxxxx in satisfaction of the requirement stated in Section 5.1(a)
shall be irrevocably binding on Xxxxxx, Licensed Parties, and Sublicensees
for
all purposes of this Agreement.
5.2 Information.
As
Licensor may reasonably request from time to time, no more than twice per
calendar year, Xxxxxx shall keep Licensor informed as to Xxxxxx’ progress in
developing, marketing and selling the Products under this Agreement.
8
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
6
CONFIDENTIAL
INFORMATION
6.1 Definition. “Confidential
Information” shall mean trade secrets, know-how, technical, business and market
information, patent disclosures, patent applications, structures, models,
techniques, formula processes, compositions, compounds, antigens, antibodies,
hybridomas, apparatus, designs, sketches, photographs, plans, drawings,
specifications, samples, reports, customer lists, price lists, studies,
findings, inventions, business and financial plans, clinical development and
clinical trial plans/status, and results, devices, device designs, absorbents,
materials, membranes, intended uses, and ideas) disclosed by one Party to the
other hereunder, but only to the extent that such information is either
marked as “CONFIDENTIAL”
or that, due to the nature of the information, the receiving party should
reasonably know is confidential.
6.2 Limitations.
Each
party
shall:
6.2.1 use
reasonable commercial
efforts to maintain the confidentiality of all Confidential
Information;
6.2.2 not
use
or permit the
use of
any Confidential Information, except as reasonably required to accomplish the
purpose of the disclosure of the Confidential Information or to exercise rights
hereunder; and
6.2.3 not
disclose
any
Confidential Information, other than to employees or agents who reasonably
require knowledge of such Confidential Information to accomplish the purpose
of
the disclosure of the Confidential Information, and who are bound by
substantially similar written obligations of confidentiality.
6.3 Property
of Disclosing Party; Return of Information.
Confidential Information and all embodiments and expressions of such
Confidential Information, including,
without
limitation, all reports, notes, reprints, descriptions, copies and summaries
thereof, shall be and remain the property of the disclosing party at all times,
and, to the extent in the disclosing party’s possession and control, and not
subject to any continuing licenses hereunder, shall be returned to the
disclosing party upon request, except for a single copy that may be retained
in
the receiving party’s legal files for record keeping purposes only.
6.4 Exclusion.
Neither
party shall be liable
for the
disclosure or use of any Confidential Information which was:
6.4.1 at
the
time of disclosure, in the possession of receiving party on a non-confidential
basis as shown
by
contemporaneous written records,
and not
as a result of any unauthorized act or omission on the part of the receiving
party or any third party;
9
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
6.4.2 independently
developed by the
receiving party; or
6.4.3 required
to be disclosed by law so long as the disclosing party is promptly given prior
written notice of the required disclosure.
6.5
Publicity.
Neither
party shall, without the prior written consent of the other party, which consent
shall not be unreasonably withheld or delayed, disclose to third parties, other
than its attorneys and accountants and other advisors on a need to know basis,
nor originate any publicity, news release or public announcement, written or
oral, whether to the public, the press, stockholders or otherwise, referring
to
this Agreement, including its existence, the subject matter to which it relates,
including without limitation the patent numbers, the performance under it or
any
of its specific terms and conditions, except such announcements or disclosures
as, in the opinion of the counsel for the party making such announcement, are
required by law, including United States securities laws, food, drug and
cosmetic laws, or patent marking laws. If a party determines that it is required
by law to make an announcement with respect to this Agreement, it will give
the
other party such notice as is reasonably practicable and an opportunity to
comment upon the announcement and will limit any such announcement to the facts
that it is advised by counsel are required to be disclosed.
ARTICLE
7
REPRESENTATIONS
AND WARRANTIES
7.1 Representations
and Warranties.
Licensor represents and warrants that: (i) it has the full right and authority
to enter into this Agreement, (ii) it owns the Patent Rights without lien or
other encumbrance; (iii) it knows of no other party having any claim to
ownership of any of the Patent Rights or of any prior act or any fact which
causes it to conclude that any of the Patents identified on Exhibit A is invalid
or unenforceable in whole or in part; (iv) it is current in the payment of
all
maintenance fees (however denominated) with respect to the Patent Rights; and
(v) it has not previously granted and will not grant any rights or licenses
in
conflict with the rights and licenses granted to Xxxxxx in this
Agreement.
7.2 Disclaimer.
Nothing
in this Agreement is or shall be construed as:
7.2.1 A
warranty or representation by Licensor as to the validity or scope of any claim
within the Patent Rights;
7.2.2 A
warranty or representation that anything made, used, sold, or otherwise disposed
of under any license granted in this Agreement is or will be free from
infringement of any patent rights of any third party;
7.2.3 An
obligation to bring or prosecute actions or suits against third parties for
infringement of any of the Patent Rights, subject to reasonable assistance
pursuant to Section 8.2; or
10
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
7.2.4 Granting
by implication, estoppel, or otherwise any licenses or rights under patents
or
other rights of Licensor or third parties, regardless of whether such patents
or
other rights are dominant or subordinate to any patent within the Patent
Rights.
7.3 Additional
Representations and Warranties.
Xxxxxx
represents and warrants that: (a) the clinical trial being conducted at the
time
of execution of this Agreement, identified as the SEPET™ Feasibility Trial,
involves the use of a blood filtration device with an albumin sieving
coefficient of approximately [*]%,; (b) each product for which it requests
permission from the FDA for purposes of a clinical study and/or commercial
marketing in satisfaction of Section 5.1 of this Agreement shall be a Product;
and (c) prior to the execution of this Agreement, it has not engaged in any
negotiations for the sublicensing or assignment of this license. Upon written
request of Licensor, Xxxxxx shall certify that the representation of clause
(b)
above applies in connection with any relevant milestone which has been met
as
specified in Section 5.1.
7.4 No
Other Warranties, Liability.
EXCEPT
AS EXPRESSLY SET FORTH IN SECTION 7.1, LICENSOR GRANTS NO WARRANTIES WITH
RESPECT TO THE PATENT RIGHTS, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION
OF LAW, BY STATUE OR OTHERWISE, AND LICENSOR SPECIFICALLY DISCLAIMS ANY EXPRESS
OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OR SCOPE OF THE PATENT RIGHTS, OR NON-INFRINGEMENT OF THE
INTELLECTUAL-PROPERTY RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL EITHER PARTY
BE LIABLE TO THE OTHER PARTY FOR ECONOMIC DAMAGES OF AN INDIRECT, SPECIAL,
INCIDENTAL, OR CONSEQUENTIAL NATURE, INCLUDING WITHOUT LIMITATION LOSS OF
PROFITS, LOSS OF USE, OR OTHER ECONOMIC LOSS.
ARTICLE
8
INTELLECTUAL
PROPERTY
8.1 Patent
Prosecution.
From
and after the Effective Date, Xxxxxx, at its sole expense and using patent
counsel selected by Xxxxxx, shall
diligently pursue in a commercially reasonable manner the filing, prosecution,
maintenance, defense and enforcement of all applications for patents and all
patents included in Patent Rights. Xxxxxx will provide Licensor a quarterly
report on the status of all efforts to prosecute, maintain, defend and enforce
all applications for patent and all patents included in Patent Rights, and
shall
respond to all reasonable requests by Licensor for information regarding the
status of Patent Rights. Xxxxxx shall keep Licensor regularly informed of all
prosecution activities and the parties shall confer in advance on actions to
be
taken in connection with the prosecution of applications for all Patent Rights.
Licensor shall, and shall use reasonable efforts (without being required to
incur any cost or expense) to cause its representatives who are inventors of
the
Patent Rights to, fully cooperate at the expense of Xxxxxx, and as reasonably
requested by Xxxxxx, in efforts relating to the filing, prosecution,
maintenance, defense and/or enforcement of all Patent Rights. Xxxxxx agrees
to
execute a letter agreement with Xxxxx Xxxxxxxx in the form attached as Exhibit
C
11
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
8.2 Patent
Enforcement.
If
either party becomes aware that any Patent Rights are being or have been
infringed by any third party, such party shall promptly notify the other party
in writing describing the facts relating thereto in reasonable detail. Xxxxxx
shall have the right, but not the obligation, to institute, prosecute and
control any action, suit or proceeding (an “Action”) with respect to such
infringement, including any declaratory judgment action, at its expense, using
counsel of its choice. Notwithstanding any other provision hereof, if either
party notifies the other party in writing that an infringement of the Patent
Rights exists, and Xxxxxx does not take reasonable steps within nine (9) months
of any such notice by Licensor to cause such infringement to cease, then for
the
following nine (9) months only, Licensor and not Xxxxxx shall have the first
right to prosecute any such infringement, and Xxxxxx shall provide reasonable
assistance (and shall use reasonable efforts to obtain assistance from the
inventors) to Licensor with respect to any such action at Licensor’s expense.
The parties agree that the party filing any action as described above may file
such action in the name of the other party if reasonably necessary. Any recovery
from any action brought hereunder shall be first allocated to reimbursing costs
incurred in such action, and the remainder allocated 90% to the party
controlling the action and 10% to the other party; provided that, if a
sublicense is granted under the Patent Rights in the course of any litigation,
then the royalty obligations of Section 3.2 and Article 4 shall apply to Net
Sales under any such sublicense agreement with respect to all sales covered
by
such sublicense in lieu of the foregoing.
8.3 Existing
Action.
This
Agreement shall not affect [*]. Licensor shall keep Xxxxxx reasonably informed
of any events related [*].
ARTICLE
9
TERM
AND TERMINATION
9.1 Term.
The
term of this Agreement will commence on the Effective Date of this Agreement
and
remain in full force and effect until the expiration of the last Patent Right,
unless earlier terminated in accordance with this Article 9.
9.2 Permissive
Termination.
Xxxxxx
may terminate this Agreement at any time by providing Licensor notice in writing
at least thirty (30) days prior to the effective date of termination.
9.3 Termination
for Cause.
Either
party may terminate this Agreement if the other party has materially breached
or
defaulted in the performance of any of its obligations hereunder, and such
default has continued for forty-five (45) days after written notice thereof
(ten
(10) days for payment breaches) was provided to the breaching party by the
nonbreaching party. Any termination shall become effective at the end of such
forty-five (45) day period (ten (10) days for payment breaches) unless the
breaching party has cured or remedied any such breach or default prior to the
expiration of such period. Notwithstanding
the foregoing, the period to cure any default to which Section 10.3 (c) is
applicable (as provided in Section 10.3(c)(i)), shall be extended until the
first to occur of (A) the mutual agreement of the parties with respect thereto,
or (B) five business days after the arbitration award with respect thereto
has
been issued, and any termination of this Agreement on account of such default
shall not become effective until such extended cure period has ended without
the
breach being cured if, but only if, all payments in controversy are made by
Xxxxxx into escrow pursuant to Section 10.3 (c) within any original cure period
for such payments (i.e., the original cure period as stated in the first
sentence of this paragraph). All such payments made by Xxxxxx in escrow must
be
accompanied by a written statement to the escrow agent, with a copy to Licensor,
identifying the original due date of the payment. The parties acknowledge and
agree that time is of the essence with respect to the actions specified in
Sections 5.1(a), (b), (c), and (d), and in making any required payments under
this Agreement.
12
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
9.4 Termination
for Insolvency.
Either
party, in addition to any other remedies available to it by law or in equity,
may terminate this Agreement by providing written notice to the other party
on
or after the occurrence of any of the following events with regard to such
other
party: (i) becoming insolvent, or admitting in writing its insolvency or
inability to pay its debts or perform its obligations as they mature; or (ii)
becoming the subject of any voluntary or involuntary proceeding in bankruptcy,
liquidation, dissolution, receivership, attachment or composition or general
assignment for the benefit of creditors that is not dismissed with prejudice
within thirty (30) days after the institution of such proceeding, attachment
or
assignment.
9.5 Effect
of Termination.
9.5.1 Accrued
Rights and Obligations. Termination of this Agreement for any reason does not
release any party hereto from any liability which, at the time of such
termination, has already accrued to the other party or which is attributable
to
a period prior to such termination nor preclude either party from pursuing
any
rights and remedies it may have hereunder or at law or in equity with respect
to
any breach of this Agreement. It is understood and agreed that monetary damages
may not be a sufficient remedy for any breach of this Agreement and that the
non-breaching party may be entitled to seek injunctive relief as a remedy for
any such breach. Such remedy shall not be considered to be the exclusive remedy
for any such breach of this Agreement, but shall be in addition to all other
remedies available at law or in equity.
9.5.2 Stock
on
Hand. If this Agreement is terminated for any reason, Xxxxxx may sell or
otherwise dispose of the stock of any Product then on hand until one year after
such termination, subject to Article 3 and Article 4 and the other applicable
terms of this Agreement.
13
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
9.5.3 Licenses.
All licenses granted hereunder (other than the license granted in Section
2.1(c)) shall terminate upon the termination of this Agreement. Licensor shall
have the unilateral right to request the assignment of any sublicense granted
prior to termination or to terminate such sublicense
9.5.4 Survival.
Sections 9.5 and Section 3.2, and Section 2.1(c), and Articles 4, 6, 8 and
10 of
this Agreement, as well as any obligation to pay royalties accruing prior to
termination, shall survive the expiration or termination of this Agreement
for
any reason.
ARTICLE
10
MISCELLANEOUS
PROVISIONS
10.1 Governing
Law.
This
Agreement and any dispute, including without limitation any arbitration, arising
from the performance or breach hereof shall be governed by and construed and
enforced in accordance with the laws of the State of New York, without reference
to the conflicts-of-laws principles thereof.
10.2 Assignment.
Neither
party may transfer or assign this Agreement or any of its rights hereunder
to
any party without the written consent of the other party, such consent not
to be
unreasonably withheld; provided, however, that (a) either party may assign
its
entire interest in this Agreement in connection with a merger or sale of
substantially all of the assets of such party relating to the subject matter
of
this Agreement without any such prior consent and (b) Licensor may assign its
right to receive royalties hereunder to one or more trusts. Subject to the
foregoing, this Agreement binds upon and inures to the benefit of the parties
and their permitted successors and assigns. No such assignment shall be
permitted unless the assigning party shall promptly notify the other party
hereto of such assignment, and the assignee shall agree for the benefit of
the
continuing party (i.e. the non-assigning party) in writing to be bound by all
duties and obligations of the assignor hereunder.
10.3 Dispute
Resolution.
(a) Any
dispute, controversy or claim arising out of or relating to this Agreement,
or
the breach, termination or invalidity thereof, shall be finally settled by
binding arbitration conducted in Chicago, Illinois under the commercial
arbitration rules of the American Arbitration Association (“AAA”). The
arbitration shall be conducted by a single independent arbitrator jointly
appointed by the parties; provided,
however,
that if
they cannot agree within thirty (30) days after the initiation of the
arbitration, then the arbitrator shall be a lawyer or former judge experienced
in patent litigation appointed by the AAA; provided further, however, that
if
the amount in controversy exceeds $[*] with respect to any calendar quarter,
then a panel of three arbitrators so qualified shall be appointed. Disputes
about arbitration procedure shall be resolved by the arbitrator(s). The
arbitrator(s) may proceed to an award notwithstanding the failure of either
party to participate in the proceedings. It is the goal of the parties that
any
arbitration proceeding be completed within twelve months of being initiated.
The
parties shall conduct themselves in good faith with the objective of achieving
that goal and the arbitrator(s) shall be instructed to manage the arbitration
accordingly. Discovery shall be limited to mutual exchange of documents relevant
to the dispute, controversy or claim; depositions shall not be permitted unless
agreed to by both Parties. The arbitrator(s) shall be authorized to grant
interim relief, including to prevent the destruction of goods or documents
involved in the dispute, protect trade secrets and provide for security for
a
prospective monetary award. The limitations on liability set out in Article
7
hereof shall apply to an award of the arbitrator(s). Specifically, but without
limitation, under no circumstances shall the arbitrator(s) be authorized to
award punitive or multiple damages. The prevailing party shall be entitled
to an
award of reasonable attorney fees incurred in connection with the arbitration
in
such amount as may be determined by the arbitrator(s). The award of the
arbitrator(s) shall be the sole and exclusive remedy of the parties and shall
be
enforceable in any court of competent jurisdiction, subject only to revocation
on grounds of fraud or clear bias on the part of the arbitrator(s).
Notwithstanding this, application may be made to any court for a judicial
acceptance of the award or order of enforcement. Notwithstanding anything
contained in this Section 10.3 to the contrary, each party shall have the right
to institute judicial proceedings against the other party or anyone acting
by,
through or under such other party, in order to enforce the instituting party’s
rights hereunder through reformation of contract, specific performance,
injunction or similar equitable relief, and either party may require that any
question of patent validity, be determined by a court of competent jurisdiction,
rather than by arbitration hereunder.
14
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
(b) Section
10.3(a) does not apply to any claim for patent infringement with respect to
any
period of time following termination of this agreement. No arbitration award
(or
suit to enforce an arbitration award) shall constitute res judicata or
collateral estoppel or otherwise be relevant to any proceeding for patent
infringement with respect to any period of time following termination of this
agreement.
(c)
Controversies
Concerning Product Classification.
(i) This
Section 10.3 (c) is applicable to a notice of default given by Licensor only
in
the following circumstances: if any Licensed Party or Sublicensee sells a
product or service that will generate revenue that Xxxxxx believes in good
faith
either (A) does not constitute Recovery because the product is neither a Product
nor an Other Product, or because the method used in the service does not
infringe a Valid Claim, or (B) is properly subject to a [*]% royalty as the
sale
of an Other Product rather than a [*]% royalty as the sale of a Product, and
Xxxxxx notifies the Licensor of such fact (the “Xxxxxx Notice”) no later than
the date on which the cure period for such notice of default would have ended
(without the effect of this Section 10.3 (c)), stating in the notice reasonably
complete reasons for its belief and currently available support therefor, and
accompanying such notice with a sample product, if relevant.
(ii)
In
the case of a notice of default to which this Section 10.3 (c) is applicable,
the parties will consult actively with one another to come to agreement on
the
question within fifteen (15) days of the Xxxxxx Notice.
15
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
(iii)
If
the parties have failed to come to agreement on the question within the period
provided above, then either party may request that the matter be resolved by
arbitration pursuant to Section 10.3(a).
(iv)
During the pendency of any dispute resolution process as provided herein, Xxxxxx
shall pay the relevant royalties into escrow. The royalty rate to be paid into
escrow shall be [*]% unless Licensor agrees that a [*]% royalty rate would
apply
under its interpretation of the facts and the Patent Rights, which
interpretation shall be made in good faith, in which case the [*]% rate shall
apply. The escrow agreement pursuant to which Xxxxxx shall make the required
payments shall be with a mutually agreeable escrow agent, or if Licensor does
not timely agree to an agent, then with an impartial agent of national
reputation appointed by Arbios, and the escrow agreement shall contain the
agent’s normal indemnity provisions and shall provide that the funds shall be
reasonably invested and shall be paid out by the escrow agent on the first
to
occur of the following: (A) receipt by the escrow agent of joint instructions
from Xxxxxx and Licensor directing such payment; or (B) receipt of and pursuant
to an arbitration award directing the escrow agent to pay out the money; or
(C)
twelve months after the original due date of the payment which was paid into
escrow, at which time the relevant payment shall be paid to Licensor, along
with
any interest earned thereon.
10.4 Waiver.
No
waiver of any rights is effective unless consented to in writing by the party
to
be charged and the waiver of any breach of default does not constitute a waiver
of any other right hereunder or any subsequent breach or default.
10.5 Severability.
If any
provisions of this Agreement are determined to be invalid or unenforceable
by a
court of competent jurisdiction, the remainder of the Agreement remains in
full
force and effect without said provision.
10.6 Notices.
All
notices, requests and other communications hereunder shall be in writing and
shall be personally delivered or sent by telecopy or other electronic facsimile
transmission or by registered or certified mail, return receipt requested,
postage prepaid, in each case to the respective address specified below, or
such
other address as may be specified in writing to the other parties
hereto:
Xxxxxx:
|
Xxxxxx
Systems, Inc.
|
0000
Xxxxxx Xxxxxx, Xxxxx 0000
|
|
Xxxxxxx,
XX 00000
|
|
Attn:
President
|
16
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
Licensor: | Immunocept LLC |
0000
Xxxxxxxxxx Xxxxxx
|
|
Xxxxxx,
XX 00000
|
|
Attn:
Xxxxx X. Xxxxxx, MD
|
|
With a copy to: |
Xxxxx
Xxxxxxxx
|
00000
Xxxxxxxxx Xxx
|
|
Xxxxxx,
XX 00000
|
10.7 Independent
Contractors.
Both
parties are independent contractors under this Agreement. Nothing contained
in
this Agreement is intended nor is to be construed so as to constitute Licensor
or Xxxxxx as partners or joint venturers with respect to this Agreement. Neither
party has any express or implied right or authority to assume or create any
obligations on behalf of or in the name of the other party or to bind the other
party to any other contract, agreement, or undertaking with any third
party.
10.8 Compliance
with Laws.
In
exercising their rights under this license, the parties shall fully comply
in
all material respects with the requirements of any and all applicable laws,
regulations, rules and orders of any governmental body having jurisdiction
over
the exercise of rights under this Agreement.
10.9 Use
of
Name.
Neither
party shall use the name or trademarks of the other party without the prior
written consent of such other party.
10.10 Entire
Agreement; Amendment.
This
Agreement including all Exhibits and the Xxxxxx Service Agreement constitute
the
entire and exclusive Agreement between the parties with respect to the subject
matter hereof and supersedes and cancels all previous discussions, agreements,
commitments and writings in respect thereof. No amendment or addition to this
Agreement is effective unless reduced to writing and executed by the authorized
representatives of the parties.
10.11 Further
Assurances.
Each
party agrees to execute, acknowledge and deliver such further instruments,
and
do such other acts, as may be necessary and appropriate in order to carry out
the purposes and intent of this Agreement.
IN
WITNESS WHEREOF, the undersigned have entered into this Agreement as of the
date
first set forth above.
IMMUNOCEPT LLC | XXXXXX SYSTEMS, INC. | |||
By: | /s/ Xxxxx Xxxxxxxx | By: | /s/ Xxxxxx Xxxxx | |
Print Name: Xxxxx Xxxxxxxx |
Print Name: Xxxxxx Xxxxx |
|||
Title: CEO |
Title:
President
|
17
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
EXHIBIT
A
PATENTS
U.S.
Appln. No. and
File
Date
|
Title
|
Inventors
|
||
10/796,882*
3/8/2004
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
||
10/826,736
4/16/2004
|
Hemofiltration
Systems, Methods and Devices Used to Treat Inflammatory Mediator
Related
Disease
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
||
10/843,933
5/12/2004
|
Hemofiltration
Systems, Methods, and Devices Used for Treatment of Chronic and Acute
Diseases
|
Xxxxxx,
Xxxxx X.
|
||
11/387,556*
3/23/2006
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
U.S.
Patent. No. and
Issue
Date
|
Title
|
Inventors
|
||
5,571,418
11/5/1996
|
Hemofiltration
of Toxic Mediator-Related Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxx,
Xxxxxx X.
|
||
6,287,516
9/11/2001
|
Hemofiltration
Systems, Methods, and Devices Used to Treat Inflammatory Mediator
Related
Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
||
6,730,266
5/4/2004
|
Hemofiltration
Systems, Methods, and Devices Used to Treat Inflammatory Mediator
Related
Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
||
6,736,972
5/18/2004
|
Method
and System for Providing Therapeutic Agents with Hemofiltration for
Reducing Inflammatory Mediator Related Diseases
|
Xxxxxx,
Xxxxx X.
|
||
6,787,040*
9/7/2004
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
Foreign
Appln. No.
and
File Date
|
Title
|
Inventors
|
||
European
02750294.7
7/24/2002
|
Hemofiltration
Systems, Methods, and Devices Used to Treat Inflammatory Mediator
Related
Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
||
European
03726057.7*
3/13/2003
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
*
[*]
18
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
EXHIBIT
B
FORM
OF WARRANT
THIS
WARRANT AND THE SECURITIES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN
REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”) OR ANY
APPLICABLE STATE LAWS, AND NO INTEREST THEREIN MAY BE SOLD, DISTRIBUTED,
ASSIGNED, OFFERED, PLEDGED OR OTHERWISE TRANSFERRED UNLESS THERE IS AN EFFECTIVE
REGISTRATION STATEMENT UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS
COVERING ANY SUCH TRANSACTION, OR SUCH TRANSACTION IS EXEMPT FROM THE
REGISTRATION REQUIREMENTS OF THE ACT AND SUCH LAWS, SUCH COMPLIANCE, AT THE
OPTION OF THE CORPORATION, TO BE EVIDENCED BY AN OPINION OF
THE
WARRANT HOLDER'S COUNSEL, IN FORM ACCEPTABLE TO THE CORPORATION, THAT NO
VIOLATION OF SUCH REGISTRATION PROVISIONS WOULD RESULT FROM ANY PROPOSED
TRANSFER OR ASSIGNMENT.
FORM
OF COMMON STOCK PURCHASE WARRANT
XXXXXX
SYSTEMS, INC.
THIS
CERTIFIES that for good and valuable consideration received, Immunocept LLC,
or
a registered assignee (the “Holder”)
is
entitled, upon the terms and subject to the conditions hereinafter set forth,
to
acquire from Xxxxxx Systems, Inc., a Delaware corporation (the “Corporation”),
up to
225,000 (Two hundred twenty-five thousand) fully paid and nonassessable shares
of common stock, par value $0.001, of the Corporation (“Warrant
Stock”)
at a
purchase price per share (the “Exercise
Price”)
of
$1.50 (the “Warrant”).
ARTICLE
1 Term
of
Warrant
Subject
to the terms and conditions set forth herein, this Warrant shall be exercisable,
in whole or in part, at any time on or after the date hereof and at or prior
to
11:59 p.m., Pacific Standard Time, on March 29th, 2013 (the “Expiration
Date”).
ARTICLE
2
Exercise
of Warrant.
The
purchase rights represented by this Warrant are exercisable by the registered
Holder hereof, in whole or in part, at any time and from time to time at or
prior to the Expiration Date by delivery of the following to the office of
the
Corporation specified in Section 13:
(a) A
duly
executed Notice of Exercise in the form attached hereto;
(b) Payment
of the Exercise Price for the shares thereby purchased either (i) by cash or
by
check or bank draft payable to the order of the Corporation, (ii) by
cancellation of indebtedness of the Corporation to the Holder hereof, if any,
at
the time of exercise in an amount equal to the purchase price of the shares
thereby purchased, or (iii) by net exercise pursuant to Section 2.1 hereof;
and
19
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
(c) This
Warrant.
Upon
the
exercise of the rights represented by this Warrant, the Holder shall be entitled
to receive from the Corporation a stock certificate in proper form representing
the number of shares of Warrant Stock so purchased.
2.1 Net
Exercise.
Notwithstanding
any provisions herein to the contrary, in the event of a Change of Control
the
Holder may elect, in lieu of exercising this Warrant by payment of cash, to
receive shares equal to the value (as determined below) of this Warrant (or
the
portion hereof being canceled) by surrender of this Warrant at the principal
office of the Corporation together with the properly endorsed Notice of Exercise
in which event the Company shall issue to the Holder, upon consummation of
such
Change of Control, a number of shares of Warrant Stock computed using the
following formula:
X
=
Y
(A-B)
A
Where X = |
the
number of shares of Warrant Stock to be issued to the
Holder
|
Y
=
|
the
number of shares of Warrant Stock purchasable under the Warrant or,
if
only a portion of the Warrant is being exercised, the portion of
the
Warrant being canceled (at the date of such
calculation)
|
A
=
|
the
fair market value of one share of the Corporation’s Warrant Stock (at the
date of such calculation)
|
B
=
|
Exercise
Price (as adjusted to the date of such
calculation)
|
For
purposes of the above calculation, the fair market value of one share of Warrant
Stock shall be the
value
received in such Change of Control by the holders of the securities as to which
purchase rights under this Warrant exist.
ARTICLE
3
Issuance
of Shares; No Fractional Shares of Scrip.
Certificates
for shares purchased hereunder shall be delivered to the Holder hereof by the
Corporation's transfer agent at the Corporation's expense within a reasonable
time after the date on which this Warrant shall have been exercised in
accordance with the terms hereof. Each certificate so delivered shall be in
such
denominations as may be requested by the Holder hereof and shall be registered
in the name of such Holder or, subject to applicable laws, such other name
as
shall be requested by the Holder. If, upon exercise of this Warrant, fewer
than
all of the shares of Warrant Stock evidenced by this Warrant are purchased
prior
to the Expiration Date, one or more new warrants substantially in the form
of,
and on the terms in, this Warrant will be issued for the remaining number of
shares of Warrant Stock not purchased upon exercise of this Warrant. The
Corporation hereby represents and warrants that all shares of Warrant Stock
which may be issued upon the exercise of this Warrant will, upon such exercise,
be duly and validly authorized and issued, fully paid and nonassessable and
free
from all taxes, liens and charges in respect of the issuance thereof (other
than
liens or charges created by or imposed upon the Holder of the Warrant Stock).
The Corporation agrees that the shares so issued shall be and will be deemed
to
be issued to such Holder as the record owner of such shares as of the close
of
business on the date on which this Warrant shall have been surrendered for
exercise in accordance with the terms hereof. No fractional shares or scrip
representing fractional shares shall be issued upon the exercise of this
Warrant. With respect to any fraction of a share called for upon the exercise
of
this Warrant, an amount equal to such fraction multiplied by the then current
price at which each share may be purchased hereunder shall be paid in cash
to
the Holder of this Warrant.
20
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
4
Charges,
Taxes and Expenses.
Issuance
of certificates for shares of Warrant Stock upon the exercise of this Warrant
shall be made without charge to the Holder hereof for any issue or transfer
tax
or other incidental expense in respect of the issuance of such certificate,
all
of which taxes and expenses shall be paid by the Corporation, and such
certificates shall be issued in the name of the Holder of this Warrant or in
such name or names as may be directed by the Holder of this Warrant; provided,
however, that in the event certificates for shares of Warrant Stock are to
be
issued in a name other than the name of the Holder of this Warrant, this Warrant
when surrendered for exercise shall be accompanied by an Assignment Form to
be
provided by the Corporation duly executed by the Holder hereof.
ARTICLE
5
No
Rights as Stockholders.
This
Warrant does not entitle the Holder hereof to any voting rights or other rights
as a stockholder of the Corporation prior to the exercise hereof.
ARTICLE
6
Exchange
and Registry of Warrant.
This
Warrant is exchangeable, upon the surrender hereof by the registered Holder
at
the above mentioned office or agency of the Corporation, for a new Warrant
of
like tenor and dated as of such exchange. The Corporation shall maintain at
the
above-mentioned office or agency a registry showing the name and address of
the
registered Holder of this Warrant. This Warrant may be surrendered for exchange,
transfer or exercise, in accordance with its terms, at such office or agency
of
the Corporation, and the Corporation shall be entitled to rely in all respects,
prior to written notice to the contrary, upon such registry.
21
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
7
Loss,
Theft, Destruction or Mutilation of Warrant.
Upon
receipt by the Corporation of evidence reasonably satisfactory to it of the
loss, theft, destruction or mutilation of this Warrant and in case of loss,
theft or destruction of indemnity or security reasonably satisfactory to it,
and
upon reimbursement to the Corporation of all reasonable expenses incidental
thereto, and upon surrender and cancellation of this Warrant, if mutilated,
the
Corporation will make and deliver a new Warrant of like tenor and dated as
of
such cancellation, in lieu of this Warrant.
ARTICLE
8
Saturdays,
Sundays and Holidays.
If
the
last or appointed day for the taking of any action or the expiration of any
right required or granted herein shall be a Saturday
or a Sunday or that is a legal holiday, then such action may be taken or such
right may be exercised on the next succeeding
day not a Saturday, Sunday or legal holiday.
ARTICLE
9
Merger,
Sale of Assets, Etc.
If
at any
time prior to the Expiration Date the Corporation proposes to effect an
acquisition of the Corporation by another entity by means of any transaction
or
series of related transactions (including, without limitation, any
reorganization, merger or consolidation) that results in the transfer of 50%
or
more of the outstanding voting power of the Corporation or sell or convey all
or
substantially all of the Corporation’s assets to any other entity (each, a
“Change of Control”), then, as a condition of such Change of Control, the
Corporation or its
successor, as the case may be, shall enter into a supplemental
agreement to make lawful and adequate provision whereby the Holder shall have
the right to receive, upon exercise of the Warrant, the kind and amount of
equity securities which would have been received upon such Change of Control
by
a Holder of a number of shares of common stock equal to the number of shares
issuable upon exercise of the Warrant immediately prior to such Change of
Control. If the property to be received upon such Change of Control is not
equity securities, or in the event of an initial public offering of securities
of the Corporation registered under the Act (whether or not such public offering
would be deemed a Change of Control), the Corporation shall give the Holder
of
this Warrant twenty (20) business days prior written notice of the proposed
effective date of such transaction, and if this Warrant has not been exercised
by or on the effective date of such transaction, it shall terminate.
Notwithstanding the foregoing, in the event of a public offering or Change
of
Control, the Holder shall have the right to deliver a Notice of Exercise to
the
Corporation conditioned upon consummation of such public offering or Change
of
Control transaction (a “Conditional Notice”). In the event of a Conditional
Notice, this Warrant shall be exercised only in the event such transaction
is
consummated, and shall be deemed so exercised immediately prior to the
consummation of such public offering or Change of Control transaction (but
after
giving effect to any adjustment to the Exercise Price).
22
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
10 Subdivision,
Combination, Reclassification, Conversion, Etc.
If
the
Corporation at any time shall by subdivision, combination, reclassification
of
securities or otherwise, change the Warrant Stock into the same or a different
number of securities of any class or classes, this Warrant shall thereafter
entitle the Holder to acquire such number and kind of securities as would have
been issuable in respect of the Warrant Stock (or other securities which were
subject to the purchase rights under this Warrant immediately prior to such
subdivision, combination, reclassification or other change) as the result of
such change if this Warrant had been exercised in full for cash immediately
prior to such change. The Exercise Price hereunder shall be adjusted if and
to
the extent necessary to reflect such change. If the Warrant Stock or other
securities issuable upon exercise hereof are subdivided or combined into a
greater or smaller number of shares of such security, the number of shares
issuable hereunder shall be proportionately increased or decreased, as the
case
may be, and the Exercise Price shall be proportionately reduced or increased,
as
the case may be, in both cases according to the ratio which the total number
of
shares of such security to be outstanding immediately after such event bears
to
the total number of shares of such security outstanding immediately prior to
such event. The Corporation shall give the Holder prompt written notice of
any
change in the type of securities issuable hereunder, any adjustment of the
Exercise Price for the securities issuable hereunder, and any increase or
decrease in the number of shares issuable hereunder.
ARTICLE
11 Transferability;
Compliance with Securities Laws.
11.1 This
Warrant may not be transferred or assigned in whole or in part without
compliance with all applicable federal and state securities laws by the
transferor and transferee (including the delivery of investment representation
letters and legal opinions reasonably satisfactory to the Corporation, if
requested by the Corporation). Subject to such restrictions, prior to the
Expiration Date, this Warrant and all rights hereunder are transferable by
the
Holder hereof, in whole or in part, at the office or agency of the Corporation
referred to in Section 2 hereof. Any such transfer shall be made in person
or by
the Holder's duly authorized attorney, upon surrender of this Warrant together
with the Assignment Form attached hereto properly endorsed.
11.2 The
Holder of this Warrant, by acceptance hereof, acknowledges that this Warrant
and
the Warrant Stock issuable upon exercise hereof are being acquired solely for
the Holder's own account and not as a nominee for any other party, and for
investment, and that the Holder will not offer, sell or otherwise dispose of
this Warrant or any shares of Warrant Stock to be issued upon exercise hereof
except under circumstances that will not result in a violation of the Act,
or
any state securities laws. Upon exercise of this Warrant, the Holder shall,
if
requested by the Corporation, confirm in writing, in a form satisfactory to
the
Corporation, that the shares of Warrant Stock so purchased are being acquired
solely for Holder's own account and not as a nominee for any other party, for
investment, and not with a view toward distribution or resale.
23
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
11.3 The
Holder understands that the Warrant Stock has not been registered under the
Act
on the basis that no distribution or public offering of the stock of the
Corporation is to be effected. The Holder realizes that the basis for the
exemption may not be present if, notwithstanding its representations, the Holder
has a present intention of acquiring the securities for a fixed or determinable
period in the future, selling (in connection with a distribution or otherwise),
granting any participation in, or otherwise distributing the securities. The
Holder has no such present intention.
11.4 Notwithstanding
the foregoing, no registration statement, no-action letter or opinion of counsel
shall be necessary for a transfer, pledge or grant of security interest by
a
holder of a Warrant (or securities issuable upon exercise thereof) (i) to a
fund, partnership, limited liability company, trust, or other entity that is
an
affiliate of such holder, (ii) to a partner or member (or retired partner or
member) of such transferring holder, or to the estate of any such partner or
member (or retired partner or member), (iii) to holder’s spouse, siblings,
lineal descendants or ancestors by gift, will or intestate succession or (iv)
in
compliance with Rule 144(k) (or any successor provision) of the Act so long
as
the Corporation is furnished with satisfactory evidence of compliance with
such
rule; provided, however, that, in the case of (i), (ii) or (iii), the transferee
agrees in writing to be subject to the terms of this Warrant to the same extent
as if he or she were an original holder hereunder.
11.5 Each
certificate representing the Warrant Stock or other securities issued in respect
of the Warrant Stock upon any stock split, stock dividend, recapitalization,
merger, consolidation or similar event, shall be stamped or otherwise imprinted
with a legend substantially in the following form (in addition to any legend
required under applicable securities laws):
THE
SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED. SUCH SHARES MAY NOT BE SOLD, OFFERED FOR
SALE, PLEDGED OR TRANSFERRED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION
STATEMENT AS TO THE SECURITIES UNDER SAID ACT OR UNLESS THE SALE OR TRANSFER
IS
EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID
ACT.
24
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
12 Representations
and Warranties.
The
Corporation hereby represents and warrants to the Holder hereof
that:
12.1 during
the period that this Warrant is outstanding, the Corporation will reserve from
its authorized and unissued common stock a sufficient number of shares to
provide for the issuance of Warrant Stock upon the exercise of this
Warrant;
12.2 the
issuance of this Warrant shall constitute full authority to the Corporation's
officers who are charged with the duty of executing stock certificates to
execute and issue the necessary certificates for the shares of Warrant Stock
issuable upon exercise of this Warrant;
12.3 the
Corporation has all requisite legal and corporate power to execute and deliver
this Warrant, to sell and issue the Warrant Stock hereunder, and to carry out
and perform its obligations under the terms of this Warrant;
12.4 all
corporate action on the part of the Corporation, its directors and stockholders
necessary for the authorization, execution, delivery and performance of this
Warrant by the Corporation, the authorization, sale, issuance and delivery
of
the Warrant Stock, the grant of registration rights as provided herein and
the
performance of the Corporation's obligations hereunder has been
taken;
12.5 the
Warrant Stock, when issued in compliance with the provisions of this Warrant
and
the Corporation's Certificate of Incorporation (as they may be amended from
time
to time), will be validly issued, fully paid and nonassessable, and free of
all
taxes, liens or encumbrances with respect to the issue thereof, and will be
issued in compliance with all applicable federal and state securities laws;
12.6 the
issuance of the Warrant Stock will not be subject to any preemptive rights,
rights of first refusal or similar rights;
12.7 Except
and to the extent as waived or consented to by the Holder, the Corporation
will
not, by amendment of its Articles of Incorporation or through any
reorganization, transfer of assets, consolidation, merger, dissolution, issue
or
sale of securities or any other voluntary action, avoid or seek to avoid the
observance or performance of any of the terms to be observed or performed
hereunder by the Corporation, but will at all times in good faith assist in
the
carrying out of all the provisions of this Warrant and in the taking of all
such
action as may be necessary or appropriate in order to protect the exercise
rights of the Holder against impairment; and
25
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
12.8 In
the
event of any taking by the Corporation of a record of the holders of any class
of securities for the purpose of determining the holders thereof who are
entitled to receive any dividend (other than a cash dividend which is the same
as cash dividends paid in previous quarters) or other distribution, the Company
shall mail to the Holder, at least ten (10) days prior to the date the
Corporation plans to take a record of any class of securities for the purpose
of
determining the holders thereof who are entitled to receive any dividend, a
notice specifying the date on which any such record is to be taken for the
purpose of such dividend or distribution.
ARTICLE
13 Notices.
All
notices required or permitted hereunder shall be in writing and shall be deemed
effectively given: (a) upon personal delivery to the party to be notified,
(b)
when sent by confirmed facsimile if sent during normal business hours of the
recipient, if not, then on the next business day, (c) five (5) days after having
been sent by registered or certified mail, return receipt requested, postage
prepaid, or (d) one (1) business day after deposit with a nationally recognized
overnight courier, specifying next day delivery, with written verification
of
receipt.
All
communications to the Corporation shall be sent to the following
address:
Xxxxxx
Systems, Inc.
0000
Xxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx,
XX 00000
Facsimile:
0-000-000-0000
Attn:
President
and
all
communications to the Holder shall be sent to the following
address:
Immunocept
LLC
0000
Xxxxxxxxxx Xxxxxx
Xxxxxx,
XX 00000
Attn:
Xxxxx X. Xxxxxx, MD
or
such
other address as the Corporation or Holder may designate by ten (10) days
advance written notice to the other parties hereto.
26
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
ARTICLE
14 Governing
Law.
This
Warrant shall be governed by and construed in accordance with the laws of the
State of New York.
27
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
IN
WITNESS WHEREOF, the Corporation has caused this Warrant to be executed by
its
duly authorized officers.
Dated:
March 29, 2007
XXXXXX
SYSTEMS, INC.
|
||||
By: | ||||
Xxxxxx X. Xxxxx |
||||
President
and Chief Executive Officer
|
28
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
NOTICE
OF EXERCISE
To: Xxxxxx
Systems, Inc.
(1) □ The
undersigned hereby elects to purchase _______ shares of common stock of Xxxxxx
Systems, Inc. pursuant to the terms of the attached Warrant and tenders herewith
payment of the exercise price in full, together with all applicable transfer
taxes, if any.
□ The
undersigned hereby elects to purchase _______ shares of common stock of Xxxxxx
Systems, Inc. pursuant to the terms of the net exercise provisions set forth
in
Section 2.1 of the attached Warrant, and shall tender payment of all applicable
transfer taxes, if any.
(2) Please
issue a certificate or certificates representing said shares of common stock
in
the name of the undersigned or in such other name as is specified
below:
______________________________________
(Name)
______________________________________
(Address)
(3) The
undersigned represents that (i) the aforesaid shares of common stock are being
acquired for the account of the undersigned for investment and not with a view
to, or for resale in connection with, the distribution thereof and that the
undersigned has no present intention of distributing or reselling such shares;
(ii) the undersigned is experienced in making investments of this type and
has
such knowledge and background in financial and business matters that the
undersigned is capable of evaluating the merits and risks of this investment
and
protecting the undersigned’s own interests; and (iii) the undersigned
understands that the shares of common stock issuable upon exercise of this
Warrant have not been registered under the Securities Act of 1933, as amended
(the “Securities Act”), by reason of a specific exemption from the registration
provisions of the Securities Act, which exemption depends upon, among other
things, the bona fide nature of the investment intent as expressed herein,
and,
because such securities have not been registered under the Securities Act,
they
must be held indefinitely unless subsequently registered under the Securities
Act or an exemption from such registration is available.
Date:__________________________
______________________________
(Signature)
29
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
EXHIBIT
C
RADUNSKY
AGREEMENT
Xxxxxx
Systems, Inc.
0000
Xxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx,
XX 00000
March
29,
2007
Xxxxx
Xxxxxxxx
00000
Xxxxxxxxx Xxx
Xxxxxx,
XX 00000
Dear
Xx.
Xxxxxxxx:
This
letter agreement is entered into ancillary to that certain License Agreement
dated March 29th, 2007, by and between Xxxxxx Systems, Inc. and Immunocept,
LLC.
Xxxxxx
hereby engages you to act as a consultant, without any compensation, but with
reimbursement of reasonable expenses that are approved in advance by Xxxxxx,
in
connection with the prosecution of Patent Rights (as defined in the License
Agreement). In this regard:
1.
|
You
will have the right (along with other representatives of Xxxxxx),
to
participate in consultations with Arbios attorneys that are advising
on
the prosecution of various patent applications included in the Patent
Rights, but you will not have authority to direct the patent prosecutions
nor make decisions about the prosecution of patent applications.
You are
not being engaged as an attorney, but rather as a business
consultant.
|
2.
|
Xxxxxx
will use all reasonable efforts to not make significant decisions
nor
instruct its patent prosecution attorneys to take significant actions
regarding Patent Rights without prior consultation with
you.
|
3.
|
You
will be generally obligated to maintain the confidentiality of the
matters
covered by your activities hereunder, but it is agreed that information
not subject to the attorney client privilege may be used by you in
consultation with the officers, directors, and legal advisors of
Immunocept in connection with its evaluation of its rights under
the
License Agreement.
|
30
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment
under Rule 24b-2 of the Securities Exchange Act of 1934.
4.
|
You
are not obligated to devote any specific amount of time to this
engagement, and it is recognized that you have other full time employment
and that the amount of time that you will devote to this engagement
is
limited in amount and with respect to
schedule.
|
5.
|
This
Letter Agreement will terminate on the earlier
of:
|
a.
|
Your
death, resignation, or notice that you are unable to continue your
consultation hereunder for any
reason.
|
b.
|
Notice
from Xxxxxx terminating this letter agreement and the consultation
at any
time after either (i) the expiration of five years from the date
hereof or
(ii) the issuance of one US patent and one foreign patent with respect
to
the Patent Rights after the effective date of the License Agreement,
whichever comes first.
|
6.
|
In
the event this Letter Agreement is terminated under clause 5 a.,
then
Immunocept will have the right to have Xxxxxx appoint another consultant
under substantially similar terms as this Letter
Agreement.
|
Please
sign and return a copy of this letter to us indicating your agreement to the
terms hereof.
Very
truly yours,
|
|||
|
|||
/s/ Xxxxxx Xxxxx | |||
Xxxxxx X. Xxxxx |
|||
President
|
Agreed:
|
|||
|
|||
/s/ Xxxxx Xxxxxxxx | |||
Xxxxx Xxxxxxxx |
31