Exhibit 2
[*] indicates that a confidential portion of the text of this agreement has been
omitted. The non-public information has been filed separately with the
Securities and Exchange Commission.
Execution Version
LICENSE AGREEMENT
This Agreement (hereinafter referred to as this "Agreement"), effective as
of this November 10, 2004, is entered into by and between XOMA Ireland Limited,
a company with limited liability organized under the laws of the Republic of
Ireland (the "Licensor"), and Zephyr Sciences Inc., a corporation duly organized
and existing under the laws of the State of Delaware (the "Company").
WHEREAS, the Licensor owns exclusive rights to the research, development
and commercialization of intellectual property relating to the Technology (as
defined below); and
WHEREAS, the Company is interested in obtaining rights for the use,
production, distribution, and marketing of products derived from the Technology
and the Licensor is willing to grant such rights, on the terms and conditions
set forth herein, so that the Technology may be developed and the benefits
enjoyed by the public.
NOW, THEREFORE, it is agreed as follows:
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall
have the following meanings:
1.1 "Affiliate" shall mean, with respect to any Entity, any Entity that
directly or indirectly controls, is controlled by, or is under common control
with such Entity.
1.2 "BPI" means a bactericidal/permeability-increasing protein molecule,
[*] and specifically includes rBPI21, opebacan (a/k/a NEUPREX(R)).
1.3 "BPI Cell Line" shall mean the cell line presently used by the Licensor
to manufacture BPI or any Improvement to or new cell lines producing BPI
developed by or for the Licensor, including, but not limited to, the genetic
material contained in the cell line from which BPI is produced.
1.4 "Category" shall mean Category 1, Category 2, Category 3 or Category 4,
each of which is mutually exclusive.
1.5 "Category 1" shall mean [*].
1.6 "Category 2" shall mean [*].
1.7 "Category 3" shall mean [*].
1.8 "Category 4" shall mean [*].
1.9 "control" and each of its derivatives shall mean, with respect to any
Entity, direct or indirect control of more than fifty percent (50%) of the
voting securities of an Entity or, if such Entity does not have outstanding
voting securities, more than fifty percent (50%) of the directorships or similar
positions with respect to such Entity.
1.10 "Entity" shall mean any corporation, association, joint venture,
partnership, limited liability company, trust, university, business, individual,
government or political subdivision thereof, including an agency, or any other
organization that can exercise independent legal standing.
1.11 "Existing Licenses" shall mean the NYU License Agreement, the Incyte
License Agreement and the Xxxxxx License Agreement.
1.12 "Fair Market Value" shall mean, as to any property, the amount which a
willing independent third party buyer, under no compulsion to buy, would pay a
willing seller, under no compulsion to sell, for such property in a voluntary,
negotiated, arms'-length transaction as of the time of such proposed sale, as
determined by the Company and the Licensor by good faith negotiations, and if
the parties, after good faith negotiations, dispute the value of such property,
the parties shall resolve such dispute in accordance with Article 8.
1.13 "Field of Use" shall mean all uses of BPI.
1.14 "Improvements" shall mean any modification of a Licensed Process or
Licensed Product or any discoveries, other technology or inventions (whether
patentable or not), information and data, in the Field of Use that, during the
term of this Agreement, the manufacture, use or sale of which would be (i)
necessary in the practice of, or would infringe an issued or pending claim
within, the Patent Rights or (ii) to the extent such modification, discovery,
other technology, invention, information or data is directed to BPI, useful in
the practice of the Patent Rights.
1.15 "Incyte License Agreement" shall mean the License Agreement, effective
as of July 9, 1998, between XOMA Corporation and Incyte Pharmaceuticals, Inc.
1.16 "Xxxxxx License Agreement" shall mean the License Agreement, effective
as of March 23, 2001, between the Xxxxxx Diabetes Center and XOMA Tech.
1.17 "Know-how" shall mean all tangible information (other than that
contained in the Patent Rights) whether patentable or not (but which have not
been patented), and all physical objects related to the Licensed Products
(including but not limited to formulations, biological samples, tissues,
animals, organisms, compounds, intermediates, Investigative New Drug
Applications ("IND"), integrated safety databases, laboratory notebooks,
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in vitro, preclinical or clinical design, information or results, other
proprietary materials, processes, including but not limited to manufacturing
processes, data, drawings and sketches, designs, testing and test results,
regulatory information of a like nature, owned by or in the possession of the
Licensor by license or otherwise) and any United States and/or foreign
trademarks or trademark applications filed by or on behalf of the Licensor
related to the Technology.
1.18 "Licensed Process(es)" shall mean any process, use or method to which
any of the Patent Rights or Know-how are directed, in whole or in part, in the
country in which the process or method is used.
1.19 "Licensed Product(s)" shall mean:
1.19.1 any product containing BPI which is covered in whole or in part by
Patent Rights or Know-how in the country in which the product is made, used,
leased or sold;
1.19.2 any product containing BPI which is manufactured using a process
which is covered in whole or in part by Patent Rights or Know-how in the country
in which the process is used; or
1.19.3 any product containing BPI which is used according to a method or
use which is covered in whole or in part by Patent Rights or Know-how in the
country in which the method is used.
1.20 "Market Price" shall mean, with respect to any shares of capital stock
or other securities of the Company, (i) if such stock or securities are listed
or admitted to trading on a national securities exchange or an inter-dealer
quotation system or traded in the over-the-counter market, the average price per
share or security, at the close, for the ten (10) trading days immediately
preceding the relevant determination date and (ii) if such stock or security is
not so listed, admitted or traded, the Fair Market Value of such stock or
security as determined by the Company and the Licensor by good faith
negotiations, and if the parties, after good faith negotiations, dispute the
price of such stock or security, the parties shall resolve such dispute in
accordance with Article 8.
1.21 "Net Sales" shall mean the total gross amounts invoiced by the Company
from the sale of Licensed Products or the practice of Licensed Processes by or
on behalf of the Company or any of its Affiliates, and from licensing, leasing,
renting or otherwise making Licensed Products available to others without sale
or other dispositions, whether invoiced or not, less only the sum of the
following:
1.21.1 usual trade discounts to customers;
1.21.2 sales, tariff duties and/or taxes directly imposed and with
reference to particular sales;
1.21.3 amounts allowed or credited on returns or rejections;
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1.21.4 bad debt deductions actually written off during the accounting
period; and
1.21.5 outbound transportation prepaid or allowed and transportation
insurance.
1.22 "Non-Licensor Patent Owners" shall mean the owners of the Patent
Rights other than the Licensor (including, without limitation, the counterparty
to each of the Existing Licenses).
1.23 "NYU" shall mean New York University, a New York corporation.
1.24 "NYU License Agreement" shall mean the Amended and Restated Research
and License Agreement, dated as of September 1, 1993, between XOMA Corporation
and NYU, as amended.
1.25 "Patent Rights" shall mean all U.S. and foreign patents and patent
applications set forth in Exhibit A and:
1.25.1 any other United States and/or foreign patent applications and/or
patents that claim priority to any of the patents or applications listed in
Exhibit A, together with any and all patents issuing thereon, including
continuations, divisionals, reexaminations, extensions, and reissue applications
and continuation-in-part applications and any United States or foreign patents
granted upon such applications, and Improvements on any of the foregoing, all of
which shall be deemed added to Exhibit A;
1.25.2 any United States and/or foreign patent applications or patents
(whether filed prior to or during the term of this Agreement) with claims
covering BPI or its manufacture or use, Improvements thereon, or corresponding
thereto, including any continuations, continuations-in-part, divisionals,
reissues, reexaminations, or extensions thereof; and
1.25.3 any United States and/or foreign patents issuing from any of the
foregoing.
For the avoidance of doubt, the parties acknowledge that, to the extent any
Patent Rights arise from or are governed by a license or other agreement with a
third party, such Patent Rights shall, for all purposes of this Agreement, be
subject to the limitations and restrictions contained in such third party
license or agreement. Notwithstanding anything in this Agreement to the
contrary, "Patent Rights" shall exclude, and the Licensor specifically does not
grant to the Company any rights under, the patents and patent applications
listed in Exhibit B.
1.26 "Peptides" shall mean peptide sequences [*] derived from BPI.
1.27 "Qualified Financing" shall mean the closing of the first financing of
the Company as a result of the sale of debt or equity securities resulting in
gross proceeds to the Company equal to or greater than [*].
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1.28 "Technology" shall mean all Know-how and Patent Rights, as well as all
other rights that the Licensor has in BPI Cell Lines, BPI or its use or
manufacture, unless expressly excepted or retained by the Licensor in this
Agreement.
1.29 "Territory" shall mean the world.
1.30 "XOMA Tech" shall mean XOMA Technology Ltd., a Bermuda company.
ARTICLE 2
GRANT
2.1 The Licensor hereby grants to the Company and the Company accepts,
subject to the terms and conditions of this Agreement, an exclusive license
(except as to the Licensor in cases where the Licensor provides development,
manufacturing or other services to the Company) in the Field of Use to practice
under the Technology and to utilize the Know-how and Improvements in the
Territory, and to (a) make, have made, use, lease, sell or offer to sell the
Licensed Products and to practice and have practiced the Licensed Processes, to
the full end of the term for which the Patent Rights are granted, unless sooner
terminated as hereinafter provided, and (b) sublicense to third parties, in
accordance with Section 2.2 below, the rights granted under clause (a) of this
Section 2.1.
2.2 In accordance with Section 2.1 above, the Licensor hereby grants to the
Company the right to grant sublicenses to third parties under the license
granted hereunder in its sole discretion; provided that each sublicensee shall,
as a condition to such sublicensee's sublicense, agree in writing to be bound by
the provisions of this Agreement as applicable to a licensee of the Licensed
Products and/or Licensed Processes and shall comply with such provisions during
the term of such sublicense.
2.2.1 Within thirty (30) days after execution or receipt thereof, as
applicable, the Company shall provide the Licensor with a copy of each
sublicense issued hereunder and shall deliver copies of all royalty reports
received by the Company from such sublicensees.
2.2.2 Upon termination of this Agreement, other than by expiration in
accordance with Section 7.6, any and all sublicenses shall survive such
termination. Notwithstanding the foregoing, if the Company believes that the
Licensor has terminated this Agreement for the primary purpose of doing business
directly with the sublicensee, the termination may be disputed under the
provisions of Article 8.
2.3 If the Company fails to close the Qualified Financing on or before [*],
the Licensor shall have the right, but not the obligation, to terminate this
Agreement at any time after [*], upon five (5) days' notice to the Company, and
until such right to terminate is exercised (if exercised), (i) the parties shall
continue to perform in accordance with the provisions of this Agreement and (ii)
the Company may continue its efforts to close the Qualified Financing (which
must occur prior to the exercise by the Licensor of its right to terminate this
Agreement).
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The Licensor's right to terminate this Agreement pursuant to this Section 2.3
shall expire upon the closing of the Qualified Financing and payment by the
Company to the Licensor of [*] pursuant to Section 4.9 hereof.
2.4 From the date of this Agreement until the HS Right Termination Date,
the parties agree that, notwithstanding Section 2.1, the Licensor retains the
right to make and sell any Licensed Products directly to the United States
Department of Homeland Security, either by itself or in conjunction with the
United States Department of Health and Human Services, or any agency or agencies
that is/are responsible for securing the continental United States against
terrorist attacks with biological agents (collectively, "Homeland Security")
solely under the provisions promulgated in the Final Rule relating to "New Drug
and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of
New Drugs When Human Efficacy Studies Are Not Ethical or Feasible" 67 Fed. Reg.
105, 37988-37998 (May 31, 2002) and the corresponding 21 C.F.R. Parts 314
Subpart I and 601 Subpart H (collectively, the "Final Rule"); provided that such
right shall not extend to (i) sales to any other end user, (ii) sales for any
reason other than the intended treatment of victims (or potential victims) of
terrorist attacks or (iii) the conduct of human efficacy clinical trials.
2.4.1 The Licensor shall provide to the Company updates of the status of
the efforts of the Licensor and its Affiliates to sell Licensed Products to
Homeland Security within thirty (30) days of the end of each calendar quarter
and in response to all reasonable requests made by the Company for such status
updates. As permitted by law and applicable government policy, the Licensor
shall provide the Company (subject to any required confidentiality restrictions)
with a copy of (i) all material written correspondence to be delivered to any
governmental agency in connection with the testing and trial of the Licensed
Products (including each interim and final report of any permitted human safety
trial) prior to delivery to any governmental agency and (ii) all written
correspondence received by the Licensor or any of its Affiliates (including,
without limitation, any requests for human clinical trials). Prior to the
commencement of any permitted human safety trials, the Licensor shall provide
the Company a written notice containing a thorough description of the trial
design intended to be conducted by the Licensor.
2.4.2 In the event the Licensor receives notice from Homeland Security
requesting that the Licensor conduct human safety clinical trials of such
Licensed Products, and (i) the dosing for such a trial is less than 3 mg/kg to
be administered over any period of 12 hours or less and (ii) the dosing regimen
for such a trial includes a bolus of 2.5 mg/kg or less to be administered in any
period of one hour or less (regardless of the amount of the total infusion) and
(iii) the dosing regimen for such a trial includes an infusion of 0.5 mg/kg or
less to be administered in any period of 15 minutes or less (regardless of the
amount of the total infusion), then the Licensor must obtain the prior written
consent of the Company to conduct the trial at the proposed dosage levels, which
consent to such dosage levels shall not be unreasonably withheld. The parties
agree that if the Company does not grant such consent, (x) the Licensor cannot
undertake such trial at such dosage levels and (y) the Licensor may submit such
matter to arbitration for resolution pursuant to Article 8. For purposes of this
Section 2.4.2, in the event of any such arbitration, either party may raise any
of the following factors to establish the reasonableness or unreasonableness of
the withholding of such consent: (a)
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whether the dosing regimen for such a trial exceeds any regimen previously
conducted using the Licensed Product, or (b) whether the conduct of such a trial
may interfere with any pending or planned clinical trial of the Company or any
of its sublicensees, or (c) whether such a trial is likely to result in a
serious adverse event in any subject of such trial, or (d) whether such a trial
relates to any indication that is not contemplated by the Final Rule; provided
that the factors in clauses (a), (b) (c) and (d) above are for illustrative
purposes only and shall not be deemed a conclusive list of factors.
2.4.3 In the event the Licensor receives a trial request from Homeland
Security requesting that the Licensor conduct human safety clinical trials of
such Licensed Products, and the dosing regimen for such a trial falls outside
the parameters set forth in Section 2.4.2 above, then the Licensor must obtain
the prior written consent of the Company to conduct the trial at the proposed
dosage levels, which consent to such dosage levels may be provided or withheld
by the Company in its sole discretion, it being agreed that if the Company does
not grant such consent, the Licensor cannot undertake such trial at such dosage
levels.
2.4.4 The Licensor shall use commercially reasonable efforts to insure that
none of the Licensed Products sold or intended to be sold to Homeland Security
are sold or conveyed into another market and in particular a market for which
human efficacy clinical trials are required, by (a) using appropriate and clear
labeling on the packaging to advise that the product is not for commercial sale
or resale and which complies with the labeling requirements of the FDA for drugs
and biologics for which no human efficacy trials have been conducted and in
particular as set out in 21 C.F.R. Parts 314 Subpart I and 601 Subpart H and (b)
providing reasonable safeguards to insure that off label sales and uses do not
occur. The Company shall have the right to audit the facilities and records of
Licensor to insure compliance with this provision.
2.4.5 The rights retained by the Licensor under this Section 2.4 shall
terminate upon the later of (the "HS Right Termination Date") [*]. On and after
the HS Right Termination Date, all sales to Homeland Security shall be made by
the Company or its sublicensee and shall be governed not by this Section 2.4 but
instead by the other applicable provisions of this Agreement, including Sections
2.1 and 4.1 hereof. Notwithstanding the foregoing, the occurrence of the HS
Right Termination Date shall not affect the right of the Licensor to perform
under any agreements in effect between the Licensor and Homeland Security as of
the HS Right Termination Date or supply any additional orders for Licensed
Products in the same indication or indications as any one or more orders placed
prior to the HS Right Termination Date, all of which shall continue to be
governed by the terms of this Section 2.4 (other than this Section 2.4.5).
2.4.6 The parties agree and acknowledge that, notwithstanding any consent
provided by the Company to the Licensor under this Section 2.4, the Company
shall have no liability resulting from, arising out of, or in connection with
any clinical trial conducted by the Licensor or any of its Affiliates in the
exercise of the Licensor's rights under this Section 2.4.
2.5 The Licensor hereby grants to the Company an exclusive sublicense in
the Field of Use to all rights granted under the NYU License Agreement (the "NYU
Sublicense").
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The Company shall fully comply with all terms and conditions of the NYU License
Agreement, as amended pursuant to an amendment to the NYU License Agreement,
dated as of November 9, 2004, a redacted copy of which is attached hereto as
Exhibit C-1 (the "NYU Amendment"). The provisions set forth below in clauses (a)
through (e), together with the NYU Amendment, shall govern the Company's
sublicense of the Licensor's rights under the NYU License Agreement. Upon
execution of this Agreement by the Licensor, the Licensor shall deliver to the
Company a redacted copy of the fully executed NYU Amendment and an
acknowledgement of NYU in substantially the form attached hereto as Exhibit C-2.
(a) The Company shall, at all times during the term of this Agreement and
thereafter, defend, indemnify and hold harmless NYU and its trustees, officers,
agents, employees, faculty and students from and against any and all liability,
loss, damages and expenses (including attorneys' fees), they may suffer as the
result of claims, demands, costs or judgments which may be made or instituted
against them or any of them arising out of the manufacture, distribution, use,
testing, sale or other disposition by Company or any Entity under common control
with the Company, distributor, customer, sublicensee or representative of the
Company or anyone in privity therewith, of any Licensed Products to the extent
such products are derived from Patent Rights owned by NYU, or any method or
process licensed by NYU to the Company hereunder or out of any representation
made by the Company pursuant to this Agreement, in each case relating to Patent
Rights and Know-how arising out of the NYU License Agreement. The Company's
obligation to defend, indemnify and hold harmless NYU shall include, but not be
limited to, claims, demands, costs or judgments, whether for money damages or
equitable relief by reason of: alleged personal injury (including death) to any
person; alleged property damage; alleged infringement of any United States or
foreign patent, copyright or other proprietary rights.
(b) Under the NYU License Agreement, NYU has agreed to notify the Licensor
as soon as NYU becomes aware of a claim or action for which indemnification may
be sought under the NYU License Agreement. The Licensor agrees to notify the
Company as soon as the Licensor is notified by NYU of NYU becoming aware of a
claim or action for which indemnification may be sought by NYU pursuant to this
Section 2.5. At NYU's request, the Company shall provide attorneys to defend
against any claim or action with respect to the subject of indemnity contained
herein, whether or not such claims are rightfully brought or filed.
(c) The Company shall not sell any Licensed Products arising out of the NYU
License Agreement nor manufacture, have manufactured, market or distribute any
Licensed Products arising out of the NYU License Agreement for commercial sale,
nor grant any rights to a third party to sell Licensed Products arising out the
NYU License Agreement or to make, have made, distribute or market any Licensed
Products arising out of the NYU License Agreement for commercial sale unless the
Company shall have first, as required by the NYU License Agreement:
(i) provided NYU and the Licensor with a certificate of insurance
proving the Company or such third party has in force, during the term of
this Agreement, a policy of insurance acceptable to NYU and the Licensor
which:
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(A) is drawn in an amount not less than five million dollars
($5,000,000) for each occurrence as a combined single limit for bodily
injury including personal injury and death and property damage; and
(B) is endorsed to name NYU, the Licensor, the Company, the
Company's sublicensees and their respective partners, trustees,
officers, directors, employees, agents and students as additional
insureds under such policy of insurance with respect to the Company's
obligations to indemnify pursuant to Section 2.5(a); and
(C) contains a stipulation that the required insurance coverage
will not be reduced, materially altered or cancelled without first
giving sixty (60) days prior written notice to NYU and the Licensor;
or
(ii) provided NYU written evidence acceptable to NYU (at the
individual full discretion of NYU) that the Company has sufficient
financial resources to support meaningfully the indemnification obligations
undertaken in Section 2.5(a); or
(iii) provided NYU with the Company's warranty and representation (and
upon request by NYU, evidence acceptable to NYU) that the Company's net
worth (excluding intangible assets) during the term of this Agreement is in
excess of five million dollars ($5,000,000), as determined in accordance
with accounting principles generally accepted in the United States and
consistently applied; or
(iv) provided NYU with a written guarantee and undertaking, in form
satisfactory, on a reasonable basis, to NYU by a party having sufficient
financial resources to support the indemnification obligations undertaken
in Section 2.5. Such party shall be required to execute in form
satisfactory, on a reasonable basis to NYU a guarantee and undertaking to:
(a) provide defense and indemnification to the NYU pursuant to Section 2.5
hereof; (b) maintain at all times required by Section 2.5 hereof sufficient
insurance or self-insurance to indemnify NYU pursuant to Section 2.5; (c)
upon written request of NYU provide evidence satisfactory, on a reasonable
basis, to NYU that such party maintains such insurance or self-insurance;
and (d) appoint an agent for service of process in the United States and
consent to jurisdiction in the federal and state courts of New York. With
respect to such third parties in each instance, NYU and the Company shall
negotiate in good faith to determine the nature an extent of the financial
resources necessary to constitute "sufficient financial resources" for
purposes of this Section 2.5(c)(iv).
(d) Unless waived in writing by NYU, the Company agrees that the liability
insurance policy or policies referred to in Section 2.5(c) above shall be
maintained in force for so long as this Agreement remains in force and for six
(6) years thereafter or as long as the Company shall make, use or sell the
Licensed Product derived from Patent Rights owned by NYU, and for six (6) years
thereafter, whichever shall be longer. The Company shall not terminate, reduce
the face value of, or otherwise materially modify such insurance coverage during
the aforementioned period of time, unless equal or greater coverage is provided
under another policy in compliance with the foregoing provisions and without a
gap in coverage.
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(e) The Company and the Licensor agree that NYU is a third party
beneficiary of the provisions set forth in Sections 2.5(a) - (d).
2.6 The Licensor hereby grants to the Company an exclusive sublicense in
the Field of Use under the Incyte License Agreement. The Company hereby agrees
to be bound by the terms and conditions of the Incyte License Agreement and
shall fully comply with all terms and conditions of the Incyte License
Agreement, in each case, as amended pursuant to an amendment to the Incyte
License Agreement, dated as of November 9, 2004, a redacted copy of which is
attached hereto as Exhibit D-1 (the "Incyte Amendment"). Upon execution of this
Agreement by the Licensor, the Licensor shall deliver to the Company a redacted
copy of the fully executed Incyte Amendment. The Licensor shall use commercially
reasonable efforts to have Incyte enter into an acknowledgement in substantially
the form attached hereto as Exhibit D-2.
2.7 The Licensor hereby grants to the Company an exclusive sublicense in
the Field of Use under the Xxxxxx License Agreement. The Company hereby agrees
to be bound by the terms and conditions of the Xxxxxx License Agreement and
shall fully comply with all terms and conditions of the Xxxxxx License
Agreement. The Licensor shall use commercially reasonable efforts to enter into
an amendment to the Xxxxxx License Agreement in substantially the form attached
hereto as Exhibit E (the "Xxxxxx Amendment").
2.8 The Licensor shall use its commercially reasonable efforts to comply
with all terms of the Existing Licenses and will take all steps reasonably
necessary to continue its compliance with such terms during the term of this
Agreement. The Licensor shall not enter into, or grant, any agreement,
amendment, modification, waiver or consent which would result in any diminution
or contravention of the rights granted to the Company by the other parties to
the Existing Licenses pursuant to the NYU Amendment, the Incyte Amendment and/or
(once executed) the Xxxxxx Amendment. Subject to the prohibition set forth in
the immediately prior sentence, (x) to the extent feasible, the Licensor shall
provide at least ten (10) days' prior notice to the Company of any proposed
change to any of the Existing Licenses and (y) the Licensor may not make any
other changes to the Existing Licenses, without the prior written consent of the
Company; provided, however, that adjustments in the financial terms favorable to
the Licensor may occur without notice to the Company and without the Company's
prior written consent (so long as such adjustment does not diminish or
contravene any rights of the Company). If the Company shall exercise its right
under the applicable amendment to an Existing License to cure a breach or
default of the Licensor, any reasonable, documented amounts (including, without
limitation, reasonable attorneys fees) paid, or expense or costs incurred, by
the Company in connection with such cure shall be a credit (and result in a
direct offset) to a portion of the Company's monetary obligations to the
Licensor under this Agreement equal to the monetary value of the reasonable,
documented amounts paid or otherwise incurred.
2.9 The Company hereby grants to the Licensor and the Licensor accepts,
subject to the terms and conditions of this Agreement (including, without
limitation, the restrictions set forth in Section 11.2), an irrevocable,
perpetual, fully paid up, exclusive sublicense under the Patent Rights, with the
right to further sublicense, to make, have made, use, lease, sell or offer to
sell products containing Peptides [*]. Any sublicense granted by the
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Licensor under this Section 2.9 shall be conditioned upon such sublicensee's
written agreement to be bound by the applicable provisions of this Agreement
(including, without limitation, the proviso set forth in the immediately
preceding sentence and the restrictions applicable to the Licensor under Section
11.2 hereof).
ARTICLE 3
COMMERCIALIZATION
3.1 Following the closing of the Qualified Financing, the Company shall use
its commercially reasonable efforts to bring a Licensed Product to market
through a thorough, vigorous and diligent program for exploitation of the
Technology as timely and efficiently as possible. Such program shall include the
preclinical and clinical development of Licensed Products, including research
and development, manufacturing, laboratory and clinical testing and marketing.
The Company shall continue active, diligent marketing efforts for Licensed
Products throughout the term of this Agreement. The Company will assume the
costs of the pre-clinical and clinical development of the Technology subsequent
to the date of the closing of the Qualified Financing. Notwithstanding the
foregoing, the Company agrees that it will:
(a) commence a Phase II clinical trial for a Licensed Product sponsored by
the Company or its sublicensee(s) (the "Initial Indication Trial")
within [*] of the closing of the Qualified Financing ("Initial Trial
Date"); and
(b) commence a Phase II clinical trial for a Licensed Product sponsored by
the Company or its sublicensee(s) in an indication other than the
indication that is the subject of Section 3.1(a) above (the "Second
Indication Trial"), within [*] of the closing of the Qualified
Financing ("Second Indication Trial Date"). The Second Indication Trial
Date shall be extended by that number of months equal to [*] minus the
number of months it takes the Company to commence the Phase II Clinical
trial indicated in Section 3.1(a) above; provided, however, the Second
Indication Trial Date shall never be less than [*] from the closing of
the Qualified Financing.
For purposes of this Section 3.1 and Section 3.2, the term "commence" shall mean
the dosing of the first patient in the applicable clinical trial.
3.2 If the Company fails to satisfy the conditions in Section 3.1(a) above,
it shall pay the Licensor [*] per month for each full calendar month in which
the Company does not commence the Initial Indication Trial following the Initial
Trial Date. Additionally, the Licensor shall credit the Company [*] per month
against the milestone payments and/or royalties (as directed by the Company) for
each full calendar month prior to the Initial Trial Date in which the Company
commences the Initial Indication Trial (such credit not to exceed [*]).
Additionally, if the Company fails to satisfy the condition of Section 3.1(b)
above, it shall pay the Licensor [*] per month for each full calendar month in
which the Company does not commence the Second Indication Trial following the
Second Indication Trial Date. Additionally, the Licensor shall credit the
Company [*] per month against milestone payments and/or royalties (as directed
by the Company) for each full calendar month prior to the Second Indication
Trial
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Date in which the Company commences the Second Indication Trial (such credit not
to exceed [*]). All rights and obligations of the parties under this Agreement
shall terminate upon termination or expiration of this Agreement except for any
rights or obligations which have accrued to the benefit of, or have been
incurred by, either party prior to such termination or expiration.
3.3 A Development Committee (the "Committee") shall be organized by the
Company to monitor the clinical progress of the Licensed Products. The Committee
will consist of independent scientific and technical thought leaders that are
highly regarded by the scientific community in the field of each Licensed
Product and at least one representative from each of the Licensor and the
Company. The Committee will be responsible for (i) making recommendations to the
Company's management relating to the pre-clinical and clinical development
strategy; (ii) analysis and assessment of ongoing pre-clinical and clinical
development of each Licensed Product; and (iii) assisting the Company to prepare
pre-clinical and clinical development budgets. The actions and opinions of the
Committee will be confidential; however, the Licensor representative may report
general status overviews to senior management of the Licensor and other
employees thereof who have a need to know such information. The Committee will
meet at least two (2) times per year. The Company shall reimburse the Committee
for any reasonable costs and expenses incurred by the Committee or its members
in connection with any review or analysis requested to be performed by the
Company.
ARTICLE 4
ROYALTIES AND OTHER CONSIDERATION
4.1 The Company agrees to pay to the Licensor the royalties set forth
below, and in accordance with the provisions of Sections 4.5 and 4.6, to (i) the
end of the term of the Patent Rights or (ii) [*] from first commercial sale of
any Licensed Product, whichever is later, or until this Agreement terminates as
hereinafter provided:
4.1.1 During the term of the License Agreement, the Company shall pay to
the Licensor royalties equal to [*] of Net Sales received by the Company
resulting from the sale of any Licensed Product by or on behalf of the Company
to an end user.
4.1.2 During the term of the License Agreement, the Company shall pay to
the Licensor royalties equal to [*] of the royalties received by the Company
resulting from sales by or on behalf of any sublicensee of Licensed Products to
an end user, provided, however, that in no case shall the Licensor receive less
than [*] of Net Sales of Licensed Products from any sublicensee to an end user.
Notwithstanding the foregoing, should the Company receive in excess of a [*]
royalty on Net Sales of a Licensed Product from a sublicensee, then the Company
will pay the Licensor [*] of such royalties received by the Company in excess of
[*] of Net Sales of Licensed Products from the sublicensee. By way of example,
should the Company receive a [*] royalty from a sublicensee, then the Licensor
shall be entitled to receive its [*] of Net Sales of Licensed Products from the
sublicensee to an end user plus [*]of Net Sales of Licensed Products from such
sublicensee to an end user (determined by giving the Licensor [*] of the [*]
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royalty in excess of [*]) for a total royalty to the Licensor equal to [*] of
Net Sales of Licensed Products from such sublicensee to an end user.
4.2 No multiple royalties shall be payable because the use, lease or sale
of any Licensed Product or Licensed Process is, or shall be, covered by more
than one valid and unexpired claim contained in the Patent Rights. In addition,
royalties shall be paid for a Licensed Product or Licensed Process based upon
only one of Sections 4.1.1 or 4.1.2 above (that is, royalties on direct sales of
a Licensed Product or Licensed Process by the Company or its Affiliates shall be
based only on clause 4.1.1, while royalties on sales of a Licensed Product or
Licensed Process by the Company's sublicensees shall be based only on clause
4.1.2, so as to avoid double counting).
4.3 In the event that a Licensed Product is sold in the form of a
combination product containing one or more products or technologies which are
themselves not a Licensed Product, the Net Sales for such combination product
shall be calculated by multiplying the sales price of such combination product
by the fraction A/(A+B) where A is the invoice price of the Licensed Product or
the Fair Market Value of the Licensed Product if sold to an Affiliate and B is
the total invoice price of the other products or technologies or the Fair Market
Value of the other products or technologies if purchased from an Affiliate. In
the case of a combination product which includes one or more Licensed Products,
the Net Sales for such combination product upon which the royalty due to the
Licensor is based shall not be less than the normal aggregate Net Sales for such
Licensed Product.
4.4 Royalty payments shall be paid in United States dollars at such place
as the Licensor may reasonably designate consistent with the laws and
regulations controlling in the United States and if applicable in any foreign
country. Any taxes which the Company, its Affiliate or any sublicensee shall be
required by law to withhold on remittance of the royalty payments shall be
deducted from such royalty payment to the Licensor. The Company shall furnish
the Licensor with the original copies of all official receipts for such taxes.
If any currency conversion shall be required in connection with the payment of
royalties hereunder, such conversion shall be made by using the exchange rate
prevailing at Citibank, N.A., in New York, New York on the last business day of
the calendar quarterly reporting period to which such royalty payments relate.
4.5 Royalties payable to the Licensor shall be paid on a quarterly basis
within thirty-five (35) days of the end of each calendar quarter. Each such
payment shall be for unpaid royalties which accrued within the most recently
completed calendar quarter.
4.6 As further consideration for the license granted hereunder, the Company
shall pay to the Licensor the following one time milestone payments (which
milestone payments shall not be deducted from royalties otherwise owed or which
may in the future be owing to the Licensor on account of sublicensing royalties
and/or lump sum payments received by the Company or its Affiliate from
sublicensees pursuant to clause 4.1.2):
4.6.1 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase II clinical trial with a Licensed Product to
treat a
13
Category 1 medical condition under a Company sponsored or Company sublicensee
sponsored IND;
4.6.2 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase III clinical trial to determine efficacy with
a Licensed Product to treat a Category 1 medical condition under a Company
sponsored or Company sublicensee sponsored IND;
4.6.3 [*] within thirty (30) days of the first date on which (x) the United
States Food & Drug Administration (the "FDA") accepts a biologics license or
other marketing application (an "NDA"), (y) the European Medicines Evaluation
Agency accepts the equivalent of an NDA or (z) the Japanese Food & Drug
Administration accepts the equivalent of an NDA (and only the first of these
three events to occur), in each case, submitted by the Company or its
sublicensee relating to a Licensed Product for the treatment of a Category 1
medical condition;
4.6.4 [*] within thirty (30) days of the approval by the FDA of an NDA
submitted by the Company or its sublicensee relating to a Licensed Product for
the treatment of a Category 1 medical condition;
4.6.5 [*] within thirty (30) days of the approval of a marketing
application by the European Medicines Evaluation Agency so that the Company or
its sublicensee may commence commercial sales of Licensed Product to treat a
Category 1 medical condition;
4.6.6 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase III clinical trial to determine efficacy with
a Licensed Product to treat a Category 2 medical condition under a Company
sponsored or Company sublicensee sponsored IND (for the avoidance of doubt, no
milestone payment shall be due as a result of the dosing of the first patient in
a Phase II clinical trial to determine efficacy with a Licensed Product to treat
a Category 2 medical condition);
4.6.7 [*] within thirty (30) days of the first date on which (x) the FDA
accepts an NDA, (y) the European Medicines Evaluation Agency accepts the
equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the
equivalent of an NDA (and only the first of these three events to occur), in
each case, submitted by the Company or its sublicensee relating to a Licensed
Product for the treatment of a Category 2 medical condition;
4.6.8 [*] within thirty (30) days of the approval by the FDA of an NDA
submitted by the Company or its sublicensee relating to a Licensed Product for
the treatment of a Category 2 medical condition;
4.6.9 [*] within thirty (30) days of the approval of a marketing
application by the European Medicines Evaluation Agency so that the Company or
its sublicensee may commence commercial sales of Licensed Product for the
treatment of a Category 2 medical condition;
14
4.6.10 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase II clinical trial with a Licensed Product to
treat a Category 3 medical condition under a Company sponsored or Company
sublicensee sponsored IND;
4.6.11 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase III clinical trial to determine efficacy with
a Licensed Product to treat a Category 3 medical condition under a Company
sponsored or Company sublicensee sponsored IND;
4.6.12 [*] within thirty (30) days of the first date on which (x) the FDA
accepts an NDA, (y) the European Medicines Evaluation Agency accepts the
equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the
equivalent of an NDA (and only the first of these three events to occur), in
each case, submitted by the Company or its sublicensee relating to a Licensed
Product for the treatment of a Category 3 medical condition;
4.6.13 [*] within thirty (30) days of the approval by the FDA of an NDA
submitted by the Company or its sublicensee relating to a Licensed Product for
the treatment of a Category 3 medical condition;
4.6.14 [*] within thirty (30) days of the approval of a marketing
application by the European Medicines Evaluation Agency so that the Company or
its sublicensee may commence commercial sales of Licensed Product for the
treatment of a Category 3 medical condition;
4.6.15 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase II clinical trial with a Licensed Product to
treat a Category 4 medical condition under a Company sponsored or Company
sublicensee sponsored IND;
4.6.16 [*] within thirty (30) days of the first date on which the Company
doses the first patient in a Phase III clinical trial to determine efficacy with
a Licensed Product to treat a Category 4 medical condition under a Company
sponsored or Company sublicensee sponsored IND;
4.6.17 [*] within thirty (30) days of the first date on which (x) the FDA
accepts an NDA, (y) the European Medicines Evaluation Agency accepts the
equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the
equivalent of an NDA (and only the first of these three events to occur), in
each case, submitted by the Company or its sublicensee relating to a Licensed
Product for the treatment of a Category 4 medical condition;
4.6.18 [*] within thirty (30) days of the first approval by the FDA of an
NDA submitted by the Company or its sublicensee relating to a Licensed Product
for the treatment of a Category 4 medical condition; and
4.6.19 [*] within thirty (30) days of the first approval of a marketing
application by the European Medicines Evaluation Agency so that the Company or
its
15
sublicensee may commence commercial sales of Licensed Product for the treatment
of a Category 4 medical condition.
Notwithstanding anything in this Section 4.6, in no event shall the Company be
obligated to pay any Milestone Payment more than one time for the Licensed
Products in Categories 1, 2 or 3.
4.7 The Company shall pay to the Licensor an amount equal to [*] of all
sublicensing fees and other lump sum payments (including milestones) or other
compensation (excluding royalties) received by the Company or an Affiliate from
its sublicensees or other third parties having a direct or indirect interest in
the proceeds from the sale of any Licensed Products for the development,
manufacture, use, lease or sale of Licensed Products to end users, other than
(a) payments received from the sale or issuance of debt or equity securities of
the Company unless such payments are made at a premium to the Market Price, in
which case, the Licensor shall be entitled to [*] of the difference between the
Market Price and the purchase price of such securities; and (b) payments
received by the Company that are (i) designated in any agreement with a third
party to be dedicated to the research and development of the Technology or
Licensed Products (including testing and FDA approvals), (ii) dedicated to
establish a marketing and sales force for sales of Licensed Products, or (iii)
in exchange for goods and/or services relating to a Licensed Product having a
Fair Market Value equivalent to the amount received by the Company. All payments
owing under this Section 4.7 shall be paid by the Company to the Licensor within
ten (10) business days of receipt by the Company of payment from the relevant
sublicensee or other third party.
4.8 The Company shall pay to the Licensor [*] of the gross proceeds the
Company actually receives from the sale of its equity or debt securities until
such time as the Licensor shall have received an aggregate of [*] from such
proceeds (the "Accruable License Fee"). In addition to the foregoing obligation
with respect to debt and equity financing that occurs after the date of this
Agreement, if the Licensor shall have not yet received the entire Accruable
License Fee (i) on or before [*], the Company shall pay the Licensor, as a
license fee, the lesser of (a) the remaining balance of the Accruable License
Fee and (b) an amount that when added to the aggregate Accruable License Fees
paid through such date equals [*] and (ii) on or before [*], the Company shall
pay the Licensor, as a license fee, the lesser of (a) the remaining balance of
the Accruable License Fee and (b) an amount that when added to the aggregate
Accruable License Fees paid through such date equals [*] (which includes all
payments made under clause (i)(b) above). All amounts payable under this Section
4.8 shall be paid within ten (10) days of the applicable determination date and
shall be credited against the Accruable License Fee and the remaining balance of
the Accruable License Fee shall be proportionately reduced. The amount payable
under Section 4.9 shall not be credited against the Accruable License Fee. Upon
termination of the License Agreement, for any reason, the Company will not be
obligated to the Licensor to pay the remaining balance, if any, of the Accruable
License Fee.
4.9 In addition to the milestone payments and royalties payable under this
Article 4, after the closing of the Qualified Financing, the Company shall pay
to the Licensor, as a license fee, [*] within five (5) days of the closing of
such financing.
For the avoidance of doubt, the obligations of the Company under Sections
4.8 and 4.9 of this Agreement relate to payments to be made after the date of
this Agreement (the failure of which
16
to be paid may provide the Licensor with a basis to assert a breach of this
Agreement) and shall not (i) constitute a condition precedent to the grant of
the license (or sublicense) rights granted to the Company under this Agreement
or (ii) result in the termination of any license (or sublicense) rights granted
hereunder, except as expressly provided in Article 7 of this Agreement.
4.10 To the extent that the Company or any Affiliate of the Company is
required, (i) after reasonable legal analysis, or (ii) by order or judgment of
any court in any jurisdiction, to obtain a license from a third party in order
to practice the rights purported to be granted to the Company by the Licensor
hereunder under Patent Rights in such jurisdiction, then up to [*] of the
royalties payable under such license in such jurisdiction may be deducted from
royalties otherwise payable to the Licensor hereunder, provided that in no event
shall the aggregate royalties payable to the Licensor in any quarterly period in
such jurisdiction be reduced (i) by more than [*] as a result of any such
deduction or (ii) by an amount that would reduce the Licensor's royalty payment
to less than [*] of Net Sales of Licensed Products from any license or
sublicensee.
4.11 The Licensor shall remit [*] of net revenues received by it to the
Company as a result of its sales, if any, to Homeland Security. For the purposes
of this Section, net revenues shall be defined as gross revenues from Homeland
Security minus (i) costs of goods sold ("COGS") determined according to GAAP,
(ii) directly related packaging and freight charges and (iii) other directly
related costs of such sales in an amount not to exceed [*] per annum. Such
sublicense fees shall be paid quarterly, due thirty-five (35) days after the
close of each calendar quarter and submitted along with a financial report
equivalent to what is required of Company under this Agreement. The Licensor
agrees to make such payments until (i) the end of the term of the Patent Rights
or (ii) [*] years from first commercial sale of any Licensed Product, whichever
is later.
4.12 To the extent the Company shall have paid to NYU, Incyte or Xxxxxx any
royalty or other payment which the Licensor was obligated to make under the
terms of any of the Existing Licenses (immediately prior to any termination) (i)
as a result of a failure of the Licensor to make such payment, or (ii) resulting
from the assumption by the Company (or its designee) of the obligations of the
Licensor under any Existing License after termination of such Existing Licenses
by the counterparty thereto (whether as a result of breach by the Licensor or
otherwise), in each case, the documented amount of such payments made by the
Company shall be credited against equal amounts owed by the Company to the
Licensor under this Agreement.
ARTICLE 5
REPORTS AND RECORDS
5.1 The Company shall keep full, true and accurate books of account
containing all particulars that may be necessary for the purpose of showing the
amounts payable to the Licensor by way of royalty as aforesaid. Said books of
account shall be kept at the Company's principal place of business and the
supporting data shall be made available up to once per year upon reasonable
notice to the Company, for three (3) years following the end of the calendar
year to which they pertain, for inspection by the Licensor's internal audit
division
17
and/or by another designated auditor selected by the Licensor, except one to
whom the Company has reasonable objection, for the purpose of verifying the
Company's royalty statement or compliance in other respects with this Agreement.
If an inspection shows an under reporting or underpayment in excess of the
greater of [*] of royalties payable for any twelve (12) month period and [*],
then the Company shall reimburse the Licensor for the cost of the inspection at
the time the Company pays the unreported royalties, including any late charges
as required by Section 5.4 of this Agreement. All payments required under this
Article 5 shall be due within fifteen (15) days of the date the Licensor
provides the Company notice of the payment due.
5.2 Within thirty five (35) days from the end of each quarter of each
calendar year, the Company shall deliver to the Licensor complete and accurate
reports, giving such particulars of the business conducted by the Company during
the preceding quarter under this Agreement as shall be pertinent to a royalty
accounting hereunder. These shall include at least the following:
5.2.1 All Licensed Products and Licensed Processes used, leased or sold by
or for the Company or its Affiliates;
5.2.2 Total amounts invoiced by the Company for Licensed Products and
Licensed Processes used, leased or sold by or for the Company or its Affiliates;
5.2.3 Deductions applicable in computed Net Sales, if any;
5.2.4 Total royalties due based on Net Sales by or for the Company or its
Affiliates or any sublicensee; and
5.2.5 Names and addresses of all sublicensees and Affiliates of the
Company.
In addition, within ninety (90) days of the end of each fiscal year of the
Company, the Company shall provide the Company's year-end financial statements
to the Licensor.
5.3 With each such quarterly report submitted, the Company shall pay to the
Licensor the royalties due and payable under this Agreement, subject to any
applicable credits. Until such time as the first Licensed Product is approved by
the FDA, the Company shall not be required to make a report pursuant to this
Article 5 (other than the provision of the Company's year-end financial
statements).
5.4 Amounts which are not paid when due and which are not the subject of a
bona fide dispute shall accrue interest from the due date until paid, at a rate
equal to the then prevailing prime rate of Citibank, N.A., plus two percent
(2%).
5.5 The Company agrees to forward to the Licensor annually a copy of any
report, which is in substance similar to the report required by this Article 5,
received from any sublicensee and other documents received from any sublicensee
as the Licensor may reasonably request, as may be pertinent to an accounting of
royalties.
18
5.6 The Licensor agrees to hold in confidence each report delivered by the
Company pursuant to this Article 5 until the termination of this Agreement.
Notwithstanding the foregoing, the Licensor may disclose any such information
required to be disclosed pursuant to any judicial, administrative or
governmental request, subpoena, requirement or order, provided that the Licensor
take reasonable steps to provide the Company with the opportunity to contest
such request, subpoena, requirement or order.
ARTICLE 6
PATENT PROSECUTION AND MAINTENANCE
6.1 Following the closing of the Qualified Financing, the Company shall
diligently prosecute and maintain the Patent Rights as set forth in Exhibit A
hereto (as the same may be amended or supplemented from time to time after the
date hereof), at its sole cost and expense, including, but not limited to, the
filing of patent applications which may be required. The Company agrees to keep
the Licensor reasonably well informed with respect to the status and progress of
any such applications, prosecutions and maintenance activities, subject to the
obligations of confidentiality set forth in Article 15 hereof, and to consult in
good faith with the Licensor and take into account the Licensor's comments and
requests with respect thereto. Both parties agree to provide reasonable
cooperation to each other to facilitate the application and prosecution of
patents pursuant to this Agreement.
6.2 The Company may, in its discretion, elect to abandon any patent
applications or issued patent in the Patent Rights. Prior to any such
abandonment, the Company shall give the Licensor at least sixty (60) days'
notice and a reasonable opportunity to take over prosecution or maintenance of
such Patent Rights. In such event, the Licensor shall have the right, but not
the obligation, to commence or continue such prosecution and to maintain any
such Patent Rights under its own control and at its expense. The Company agrees
to cooperate in such activities including execution of any assignments or other
documents necessary to enable the Licensor to obtain and retain sole ownership
and control of such Patent Rights.
ARTICLE 7
TERMINATION
7.1 If the Company shall file a petition in bankruptcy, an involuntary
petition for bankruptcy is filed against the Company and not contested with
ninety (90) days of such filing, or if the business of the Company shall be
placed in the hands of a receiver, assignee or trustee for the benefit of
creditors, whether by the voluntary act of the Company or otherwise, this
Agreement shall automatically terminate.
7.2 If the Company fails to make payment to the Licensor of royalties,
milestones or other amounts due in accordance with the terms of this Agreement
which are not the subject of a bona fide dispute between the Licensor and the
Company, the Licensor shall have the right to terminate this License Agreement
within ten (10) days after giving written
19
notice of termination unless the Company shall pay to the Licensor, within the
10-day period, all such royalties, milestones or other amounts due and payable
that are not the subject of a bona fide dispute. In the event of a bona fide
dispute over royalties, milestones or other amounts due and payable, the parties
shall resolve such dispute in accordance with Article 8. Subject to Article 8
and the immediately preceding sentence, upon the expiration of the 10-day
period, if the Company shall not have paid all such royalties, milestones or
other amounts due and payable, the rights, privileges and license granted
hereunder shall, at the option of the Licensor, immediately terminate.
7.3 Upon any material breach or default of this Agreement by the Company,
other than as set forth in Sections 7.1 and 7.2 above, the Licensor shall have
the right to terminate this Agreement and the rights, privileges and license
granted hereunder by giving sixty (60) days prior written notice to the Company.
Subject to Article 8, such termination shall become effective immediately unless
the Company shall have cured any such breach or default prior to the expiration
of such 60-day period referred to above. If a dispute regarding termination is
addressed according to Article 8, the licenses and rights granted under this
Agreement shall remain in full force and effect until such dispute is settled in
a manner that is not further appealable or not appealed.
7.4 The Company shall have the right at any time to terminate this
Agreement in whole, for any reason or no reason, by giving sixty (60) days
notice thereof in writing to the Licensor.
7.5 Upon termination of this Agreement for any reason, all monetary
obligations of a party that would accrue or be incurred by such party after the
date of such termination shall be released and terminated; provided, however,
nothing herein shall be construed to release either party from any obligation
that matured prior to the effective date of such termination or obligations
under Articles 4, 5, 8, 9, 10, 11, 14, 16 and 19 and Sections 2.4 and 3.2. The
Company and/or any sublicensee thereof may, however, after the effective date of
any such termination by the Company due to a material breach or default of this
Agreement by the Licensor and continuing for a period not to exceed six (6)
months thereafter, sell all completed Licensed Products, provided that the
Company shall pay or cause to be paid to the Licensor the royalties thereon as
required by Article 4 of this Agreement and shall submit the reports required by
Article 5 hereof on the sales of Licensed Products. All representations and
warranties contained in this Agreement (including the schedules hereto) shall
survive during the term of this Agreement and, in the case of a termination by
the Company due to a material breach or default of this Agreement by the
Licensor, for the [*] after such termination.
7.6 If not terminated sooner, this Agreement shall terminate, on a country
by country basis, on (i) the date of the last to expire claim contained in the
Patent Rights or (ii) thirteen (13) years from first commercial sale of any
Licensed Product, whichever is later.
20
ARTICLE 8
DISPUTE RESOLUTION
8.1 Any dispute arising from or relating to the amount of any payments to
be made, or alleged to be made, under Article 3 or Article 4 of this Agreement,
or arising under Section 2.4.2 of this Agreement, shall be determined before a
tribunal of three arbitrators in New York, New York in accordance with the rules
of the American Arbitration Association. One arbitrator shall be selected by the
Licensor, one arbitrator shall be selected by the Company and the third
arbitrator shall be selected by mutual agreement of the first two arbitrators.
8.2 Any other claim, dispute, or controversy arising from this Agreement
and the provisions hereof (including, without limitation, the validity,
enforceability, or infringement of any patent contained in the Patent Rights
licensed hereunder and/or the license of the Patent Rights) shall be resolved in
any court as to which the parties have submitted to jurisdiction pursuant to
Section 19.10 hereof.
8.3 In the event that, in any arbitration proceeding, any issue other than
the amount and/or existence of any payment obligation under Article 3 or Article
4 shall arise, the arbitrators shall, to the extent possible, resolve only the
issues relating to the amount and/or existence of any payment obligation under
Article 3 or Article 4; in any event, the arbitrators shall not delay the
arbitration proceeding for the purpose of obtaining or permitting either party
to obtain judicial resolution of any other issues, unless an order staying the
arbitration proceeding shall be entered by a court of competent jurisdiction.
8.4 The costs of such arbitration shall be borne proportionate to the
finding of fault as determined by the arbitrators. Judgment on the arbitration
award may be entered by any court of competent jurisdiction.
ARTICLE 9
INFRINGEMENT AND OTHER ACTIONS
9.1 Each of the parties shall, promptly after receipt of notice or other
indication of alleged infringement by a third party of the Patent Rights,
provide written notice to the other party of such alleged infringement and
provide such other party with any available evidence of such infringement.
9.2 During the term of this Agreement, the Company shall have the right,
but not the obligation, to prosecute and/or defend, at its own expense and
utilizing counsel of its choice, any infringement of, and/or challenge to, the
Patent Rights. In furtherance of such right, the Licensor hereby agrees that the
Company may join the Licensor as a party in any such suit (and will join at the
Company's request), provided that the Company pay all of the Licensor's
reasonable out-of-pocket expenses. Any recovery of damages pursuant to this
Section 9.2 shall be retained entirely by the Company and allocated pursuant to
9.4 below. In addition, the
21
Company shall defend, indemnify and hold the Licensor, its Affiliates and their
respective directors, officers, shareholders, agents, successors and permitted
assigns harmless from and against any costs, expenses or liability that may be
found or assessed against the Licensor in any such suit, other than those
resulting from the Licensor's gross negligence or willful misconduct or any fact
or condition the existence of which constitutes a breach of any representation
or warranty made by the Licensor to the Company in Article 17 hereof.
9.3 In the event that a claim or suit is asserted or brought against the
Company alleging that the manufacture or sale of any Licensed Product by the
Company, an Affiliate of the Company, or any sublicensee, or the use of such
Licensed Product by any customer of any of the foregoing, infringes proprietary
rights of a third party, the Company shall give written notice thereof to the
Licensor. The Company may, in its sole discretion, modify such Licensed Product
to avoid such infringement and/or may settle on terms that it deems advisable in
its sole discretion, subject to Section 9.2. Otherwise, the Company shall have
the right, but not the obligation, to defend any such claim or suit.
9.4 Any recovery of damages by the Company, in any such suit, shall be
applied first in satisfaction of any unreimbursed expenses and legal fees of the
Company relating to the suit. The balance remaining from any such recovery shall
be treated as royalties received by the Company from sublicensees and shared by
the Licensor and the Company in accordance with clause 4.1.1 or 4.1.2 hereof, as
applicable.
9.5 If within six (6) months after receiving notice of any alleged
infringement, the Company shall have been unsuccessful in persuading the alleged
infringer to desist, or shall not have brought and shall not be diligently
prosecuting an infringement action, or if the Company shall notify the Licensor,
at any time prior thereto, of its intention not to bring suit against the
alleged infringer, then, and in those events only, the Licensor shall have the
right, but not the obligation, to prosecute, at its own expense and utilizing
counsel of its choice, any infringement of the Patent Rights, and the Company
may, for such purposes, join the Licensor as a party plaintiff. The total cost
of any such infringement action commenced solely by the Licensor shall be borne
by the Licensor and the Licensor shall keep any recovery or damages for
infringement or otherwise derived therefrom and such shall not be applicable to
any royalty obligation of the Company.
9.6 In any suit to enforce and/or defend the Patent Rights pursuant to this
Agreement, the party not in control of such suit shall, at the request and
expense of the controlling party, cooperate in all respects and, to the extent
possible, have its employees testify when requested and make available relevant
records, papers, information, samples, specimens, and the like.
ARTICLE 10
LIMITATION OF LIABILITY, INDEMNITIES
10.1 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR
MAKES NO REPRESENTATIONS AND EXTENDS NO
22
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED
TO, WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE.
10.2 The Company agrees to defend, indemnify and hold the Licensor, its
Affiliates and their respective directors, officers, shareholders, agents,
successors and permitted assigns harmless from and against all losses,
liabilities, claims, obligations, penalties, damages, costs and expenses
(including all attorneys' fees and disbursements and other costs reasonably
incurred or sustained in connection with the investigation, defense or
prosecution of any such claim or any action or proceeding ("Losses") relating to
or arising directly or indirectly: (a) out of use by the Company or its
transferees of inventions licensed or information furnished under this Agreement
or (b) out of any use, sale or other disposition by the Company or its
transferees of Patent Rights, Licensed Products or Licensed Processes, in each
case which are not the result of the Licensor's gross negligence or willful
misconduct or any fact or condition the existence of which constitutes a breach
of any representation or warranty made by the Licensor to the Company in Article
17 hereof. The Company agrees that any sublicense agreement it enters relative
to the Licensed Products and/or Licensed Processes shall contain a covenant by
such sub-licensee providing for the indemnification of the Licensor as provided
in this Article 10.
10.3 The Licensor agrees to defend, indemnify and hold the Company, its
Affiliates and their respective directors, officers, shareholders, agents,
successors and permitted assigns harmless from and against, and shall pay and
reimburse the foregoing persons for, any and all Losses relating to or arising,
directly or indirectly, out of the breach (or alleged breach if asserted by a
third party) of (i) any representation or warranty of the Licensor contained in
this Agreement, (ii) any covenant or agreement of the Licensor contained in this
Agreement, (iii) any agreement between the Licensor and any third party in
existence as of the date of this Agreement (including all clinical trial
agreements and all agreements containing indemnification obligations of the
Licensor), or (iv) any clinical trial conducted by the Licensor or any of its
Affiliates pursuant to Section 2.4 hereof. All Losses as to which the Company
shall be entitled to recover from the Licensor under this Section 10.3 may be
credited against any amounts owing by the Company to the Licensor under this
Agreement.
10.4 A party seeking indemnification pursuant to Section 10.2 or 10.3 (an
"Indemnified Party") shall give prompt notice to the party from whom such
indemnification is sought (the "Indemnifying Party") of the assertion of any
claim or assessment, or the commencement of any action, suit or other
proceeding, by a third party in respect of which indemnity may be sought
hereunder (a "Third Party Claim") and will give the Indemnifying Party such
information with respect thereto as the Indemnifying Party may reasonably
request, but no failure to give such notice shall relieve the Indemnifying Party
of any liability hereunder (except to the extent the Indemnifying Party has
suffered actual and material prejudice thereby). The Indemnifying Party shall
have the right, exercisable by written notice to the Indemnified Party within 14
days of receipt of notice from the Indemnified Party of commencement of or
assertion of any Third Party Claim, to assume the defense of such Third Party
Claim, using counsel selected by the Indemnifying Party and reasonably
acceptable to the Indemnified Party; provided, that if the Indemnified Party
shall have been advised by counsel that under applicable standards of
professional responsibility, a conflict will arise in the event both the
Indemnified
23
Party and the Indemnifying Party are represented by the same counsel with
respect to the Third Party Claim, such Indemnified Party shall have the right to
separate counsel for the defense of such Third Party Claim and all Losses in
connection therewith shall be reimbursed by the Indemnifying Party from time to
time upon demand of the Indemnified Party. The Indemnifying Party or the
Indemnified Party, as the case may be, shall in any event have the right to
participate at its own expense, in the defense of any Third Party Claim which
the other is defending. The Indemnifying Party, if it shall have assumed the
defense of any Third Party Claim in accordance with the terms hereof, shall have
the right, upon 30 days' prior written notice to the Indemnified Party, to
consent to the entry of judgment with respect to, or otherwise settle, such
Third Party Claim unless (i) the Third Party Claim involves equitable or other
non-monetary damages, (ii) in the reasonable judgment of the Indemnified Party
such settlement would have a continuing material adverse effect on the business
of the Indemnified Party (including any material impairment of relationships
with customers or suppliers) or (iii) the terms of such settlement do not
include a full release of the Indemnified Party from the liability in connection
with such Third Party Claim, in which cases such settlement only may be made
with the written consent of the Indemnified Party, which consent shall not be
unreasonably withheld. The Indemnified Party shall have the sole and exclusive
right to settle any Third Party Claim, on such terms and conditions as it deems
reasonably appropriate, (A) if the Indemnifying Party fails to assume the
defense in accordance with the terms hereof or (B) to the extent such Third
Party Claim involves equitable or other non-monetary relief, and shall have the
right to settle any Third Party Claim involving monetary damages with the
consent of the Indemnifying Party, which consent shall not be unreasonably
withheld.
ARTICLE 11
OTHER AGREEMENTS
11.1 In connection with the transfer of the Technology, the Licensor shall,
to the extent permitted by law, provide the Company with, sell to the Company
(as specifically indicated below and only to the extent requested by the
Company), and/or give the Company access to the following: (i) copies of all
regulatory submissions by the Licensor, its Affiliates, contractors or agents,
(ii) copies of or access to all patient records (including those held by
physicians, care facilities, or clinical trial organizations) to the extent the
Licensor has copies thereof or can provide access thereto, (iii) copies of all
computer data and reports pertaining to clinical trials, (iv) copies of all
adverse event reports, (v) copies of all pre-clinical evaluations, (vi) any
clinical trial material in the Licensor's possession that has not expired at
cost plus [*], (vii) storage of and access permission to biological samples,
(viii) physicians, CROs and health care administrators involved in trials, to
the extent such persons are available, (ix) all drug manufacture files along
with the right to use manufacturing processes, (x) remaining quantities of any
active pharmaceutical ingredient intermediates pursuant to the terms of a supply
agreement to be negotiated between the parties and (xi) all other information
that the Company may reasonably request from the Licensor. All costs related to
the duplication and transfer of such materials shall be borne by the Company. In
addition, the Licensor shall assign or, if the Licensor is legally prohibited
from assigning or the parties agree to cross-reference, cross-reference to the
Company all regulatory filings relating to Licensed Products; provided that the
24
Licensor shall have access to such regulatory filings related to the Licensed
Products to the extent necessary to assist in the sale of Licensed Products to
Homeland Security pursuant to Section 2.4 hereof. To the extent that the
Licensor has access to patient records, data, computer files, patient samples or
other patient clinical trial information, the Licensor, to the extent permitted
by law, on written request by the Company, shall arrange for the Company access
to such documents, information, materials and CT Agreements (as defined below).
The Licensor will promptly notify the Company of any ongoing clinical trial
responsibilities (including patient monitoring and follow-up) under the CT
Agreements and shall allow the Company to decide, in its sole discretion,
whether to assume such obligations and, to the extent the Company elects not to
assume such obligations, such obligations shall remain the sole responsibility
of the Licensor. From time to time during the term of this Agreement, at the
request and expense of the Company, the Licensor agrees to execute and deliver
to the Company such documents and take such other actions as the Company may
reasonably request in order to consummate more effectively the transactions
contemplated hereby. The Licensor shall reasonably cooperate with the Company
and provide the Company with such assistance as reasonably may be requested by
the Company, including with respect to the transfer of clinical data and filings
with the FDA.
11.2 In consideration of the obligations of the Company under this
Agreement and the payments made, and to be made, by the Company to the Licensor,
and for other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Licensor shall not (and shall cause its
employees, consultants and agents not to), for a period commencing on the date
hereof and ending (x) in the case of a termination resulting from a breach by
the Licensor or its Affiliate, [*] after the termination of this Agreement or
(y) in all other cases, upon the termination of this Agreement, by business
operation, joint venture, partnership, merger, consolidation, acquisition,
ownership of securities or otherwise, develop, commercialize, operate, manage,
control, finance, consult with, engage or participate in any manner in any
business or activity anywhere in the world that uses one or more Peptides for
treatment of any of the indications set forth on Schedule 11.2 attached hereto.
The Licensor acknowledges that a violation or threatened violation of any of the
provisions of this Section 11.2 may result in the Company sustaining irreparable
harm, which result may not be adequately redressed by the payment of damages to
the Company and, therefore, in addition to any other remedies that the Company
may have under this Agreement or otherwise, the Company shall be entitled to
apply to any court of competent jurisdiction, at law or in equity, for an
injunction, without providing any bond, enjoining or restraining any such
violation, including the rescission of any violative transaction to the extent
permissible under applicable law. If, for any reason, a court of competent
jurisdiction shall find any of the provisions of this Section unreasonable in
duration, geographic scope or otherwise, the prohibitions contained herein shall
be restricted to such time and geographic area as such court determines to be
reasonable and that reflect the intention of the parties to the fullest extent
permissible. Such restriction shall apply only with respect to the operation of
such provisions in the particular jurisdiction in which such adjudication is
made. The parties agree that the list of indications included on Schedule 11.2
may be supplemented by the Company, at any time during the term of this
Agreement, with any additional indications that the Company or its sublicensee
has formally committed to pursue, as evidenced by the initiation of a
development program therefor, by providing the Licensor with written notice of
such additional indication(s) and the initiation of such program(s); provided
that
25
any such additional indication(s) shall only be added to Schedule 11.2 if, at
the time of such notice, the Licensor or an Affiliate has not commenced a
development program to develop a compound for treatment of such indication.
11.3 The Licensor hereby authorizes the Company (a) to include in any NDA
for a Licensed Product, as the Company may deem appropriate under the Federal
Food, Drug and Cosmetic Act (the "Act"), a list of patents included among the
Licensed Patents that relate to such Licensed Product and such other information
as the Company in its reasonable discretion believes is appropriate to be filed
pursuant to the Act; (b) to commence suit for any infringement of the Licensed
Patents under ss. 271(e) (2) of Title 35 of the United States Code occasioned by
the submission by a third party of an IND, an Abbreviated New Drug Application
(as that term is defined in the Act) for a Licensed Product pursuant to ss.
505(j) of the Act or an NDA for a Licensed Product pursuant to ss. 505(b)(2) of
the Act; and (c) subject to the Licensor's consent (which consent will not be
unreasonably withheld or delayed), to exercise any rights that may be
exercisable by Licensor as patent owner under the Act to apply for an extension
of the term of any patent included among the Licensed Patents. In the event that
applicable law in any other country of the Territory hereafter provides for the
extension of the term of any patent included among the Licensed Patents in such
country, upon request by and at the expense of the Company, the Licensor shall
use commercially reasonable efforts to obtain such extension or, in lieu
thereof, shall authorize the Company or, if requested by the Company or its
sublicensees to apply for such extension, in consultation with the Licensor. The
Licensor, at the Company's expense, agrees to reasonably cooperate with the
Company or its sublicensees, as applicable, in the exercise of the authorization
granted herein or which may be granted pursuant to this Section and will execute
such documents and take such additional actions as the Company may reasonably
request in connection therewith, including, if necessary, permitting itself to
be joined as a proper party in any suit for infringement brought by the Company
under clause (b) above. The provisions of this Section 11.3 shall apply to any
suit for infringement brought by the Company under clause (b) above. In the
event the Company decides not to commence suit for infringement under clause (b)
above, the Company will notify the Licensor of its decision within twenty-five
(25) days after the receipt of notice that the third party has made a
certification described in ss. 505(b)(2)(A)(iv) or 505(j)(2)(A)(vii)(IV) of the
Act, so that Licensor may institute such litigation itself, if it wishes, at its
own cost and expense.
11.4 The Licensor shall promptly provide to the Company a copy of each (i)
written notice (including, without limitation, relating to termination,
amendment, cancellation or acceleration), (ii) request for waiver, consent,
amendment or modification, and (iii) other material written materials, in each
case, received on or after the date of this Agreement by the Licensor or any of
its Affiliates in connection with each Material Agreement.
11.5 The Licensor covenants that it will not during the term of this
Agreement (a) cause or assist in the assertion, instigation, maintenance or
pursuit of any claim against the Company based on or alleging infringement of
any rights under any of the patents or patent applications listed in Exhibit B
or any and all patents issuing thereon, including continuations, divisionals,
reexaminations, extensions, and reissue applications and continuation-in-part
applications and any United States or foreign patents granted upon such
applications in connection with the practice by the Company of any of its rights
granted hereunder other than
26
with respect to Peptides or (b) enter into a license with respect to, or
otherwise convey rights under, any of the patents and patent applications listed
in Exhibit B to any third party relating to (i) peptide sequences [*] derived
from BPI or (ii) any licensed products comprising, or licensed processes
utilizing, peptide sequences [*] derived from BPI.
ARTICLE 12
ASSIGNMENT
This Agreement and the rights and duties appertaining hereto may not be
assigned by either party without first obtaining the written consent of the
other which consent shall not be unreasonably withheld. Any such purported
assignment, without the written consent of the other party, shall be null and of
no effect. Notwithstanding the foregoing, each party may assign this Agreement
without the consent of the other party (i) to a purchaser, merging or
consolidating corporation, or acquiror of substantially all of the assignor's
assets or business and/or pursuant to any reorganization qualifying under
section 368 of the Internal Revenue Code of 1986, as amended, as may be in
effect at such time, or (ii) in whole or in part to an Affiliate of the
assignor; provided that the Licensor may not assign any portion of this
Agreement that relates to NYU or Incyte as provided above unless the assignee is
assigned all of the Licensor's rights and obligations under the Incyte License
Agreement and the NYU License Agreement. The Licensor may not assign or
terminate any rights held by Licensor as of the date of this Agreement with
respect to the Patent Rights arising from any license, agreement or arrangement
with any Non-Licensor Patent Owner without the prior written consent of the
Company.
ARTICLE 13
PAYMENT OF FEES AND EXPENSES
Each of the Company and the Licensor shall be responsible for their own
expenses relating to the preparation and consummation of this Agreement and the
agreements and transactions contemplated hereby.
ARTICLE 14
USE OF NAMES AND PUBLICATION
14.1 Nothing contained in this Agreement shall be construed as granting any
right to the Company or its Affiliates to use in advertising, publicity, or
other promotional activities any name, trade name, trademark, or other
designation of the Licensor or any of its units (including contraction,
abbreviation or simulation of any of the foregoing) without the prior, written
consent of the Licensor; provided, however, that the Licensor acknowledges and
agrees that the Company may use the names of the Licensor in various documents
used by the Company for capital raising and financing without such prior written
consent where the use of such names may be required by law. Notwithstanding the
foregoing, the Licensor hereby grants
27
to the Company for the term of this Agreement a non-exclusive, royalty free
license to use any United States and/or foreign trademarks or trademark
applications filed by or on behalf of the Licensor related to the Technology,
the Patent Rights, Licensed Products or Licensed Processes, including
NEUPREX(R).
14.2 Nothing herein shall be deemed to establish a relationship of
principal and agent between the Licensor and the Company, nor any of their
agents or employees for any purpose whatsoever.
14.3 The Licensor and the Company agree to the release of a press release
in the form attached hereto as Schedule 14.3 upon full execution of this
Agreement and that the consummation of this Agreement, as well as such terms as
are expressly described in such press release, shall be deemed to be in the
public domain. Subject to either party's disclosure obligations under law, the
Licensor and the Company shall cooperate with each other in the development and
distribution of all further news releases and other written statements for
general circulation relating primarily to the transaction contemplated hereby.
ARTICLE 15
PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any payment, notice or other communication required or permitted to be
given pursuant to this Agreement shall be in writing and sent by certified first
class mail, postage prepaid, by hand delivery or by facsimile if confirmed in
writing, in each case effective upon receipt, at the addresses below or as
otherwise designated by written notice given to the other party:
In the case of the Licensor:
XOMA Ireland Limited
Xxxxxxx Xxxxxxx Xxxxx
Xxxxxxx Xx., Xxxxx
Xxxxxxx
Attention: Company Secretary
Fax:
with a copy to:
Xxxxxx Xxxxxx & Xxxxxxx LLP
00 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn.: Xxxxxxxx X. Xxxxxxxx, Esq.
Fax: 000-000-0000
28
In the case of the Company:
Zephyr Sciences Inc.
00 Xxxxx Xxxxxx
00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: President
Fax: (000) 000-0000
With a copy to:
Reitler Xxxxx & Rosenblatt
00 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn.: Xxxxx X. Xxxxxxxxxx, Esq.
Fax: 000-000-0000
ARTICLE 16
CONFIDENTIALITY
16.1 Any and all proprietary or confidential information relating to the
Patent Rights (including but not limited to Know-how and patent prosecution
documents relating to Patent Rights) collectively constitute the "Confidential
Information." The Company and the Licensor agree that they will not use the
Confidential Information for any purpose unrelated to this Agreement, and will
hold it in confidence during the term of this Agreement and for a period of five
(5) years after the termination or expiration date of this Agreement. The
Company shall exercise with respect to such Confidential Information the same
degree of care as the Company exercises with respect to its own confidential or
proprietary information of a similar nature, and shall not disclose it or permit
its disclosure to any third party (except to those of its employees,
consultants, or agents who are bound by the same obligation of confidentiality
as the Company is bound by pursuant to this Agreement). However, such
undertaking of confidentiality by the Company shall not apply to any information
or data which:
16.1.1 The Company receives at any time from a third party lawfully in
possession of same and having the right to disclose same;
16.1.2 Is, as of the date of this Agreement, in the public domain, or
subsequently enters the public domain through no fault of the Company;
16.1.3 Is independently developed by the Company as demonstrated by written
evidence without reference to information disclosed to the Company by the
Licensor;
16.1.4 Is disclosed pursuant to the prior written approval of the Licensor;
or
29
16.1.5 Is required to be disclosed pursuant to law or legal process
(including, without limitation, to a governmental authority) provided, in the
case of disclosure pursuant to legal process, reasonable notice of the impending
disclosure is provided to the Licensor and the Licensor has agreed to such
disclosure in writing or has exhausted its right to contest such disclosure.
ARTICLE 17
REPRESENTATIONS AND WARRANTIES OF LICENSOR
The Licensor represents and warrants to the Company, as of the date of this
Agreement, that:
17.1 The Licensor is a company with limited liability duly organized,
validly existing and in good standing under the laws of the Republic of Ireland.
The Licensor has the requisite power and authority to execute and deliver this
Agreement and the other agreements contemplated hereby to which it is a party
and to consummate the transactions contemplated hereby and thereby. The
execution and delivery of this Agreement and the other agreements contemplated
hereby to which the Licensor is a party and the performance and consummation of
the transactions contemplated hereby and thereby by the Licensor have been duly
authorized by all necessary action on the part of the Licensor. This Agreement
and the other agreements contemplated hereby to which the Licensor is a party
have been duly executed and delivered by the Licensor and, subject to the due
authorization, execution and delivery of such agreements by the other parties
thereto, this Agreement and such other agreements contemplated hereby constitute
valid and binding obligations of the Licensor, enforceable against the Licensor
in accordance with their respective terms, except as such enforcement may be
affected by bankruptcy, reorganization, insolvency, moratorium or similar laws
affecting creditor's rights generally and except for general principles of
equity.
17.2 The execution and delivery of this Agreement and the other agreements
contemplated hereby do not, and the consummation of the transactions
contemplated hereby and thereby will not, (i) conflict with, or result in any
violation or breach of any provision of the organizational documents of the
Licensor, (ii) conflict with or violate any applicable foreign, Federal, state
and local statutes, judgments, decrees, laws, ordinances, rules, regulations,
injunctions and orders ("Laws") of any U.S. Federal, state, foreign or local
government or any court, tribunal, administrative agency or commission or other
governmental or regulatory authority, body or agency, including any
self-regulatory organization ("Governmental Authorities") applicable to the
Licensor or any of its assets or operations or any permit applicable to the
Licensor or (iii) result in (x) any violation or breach of, constitute (with or
without notice or lapse of time or both) a default under or conflict with (or
give rise to a right of termination, amendment, cancellation or acceleration of
any material obligation or loss of any benefit under) the provisions of any
lease, contract or other agreement to which the Licensor is a party or by which
it or any of its properties or assets is otherwise bound or (y) the imposition
of any lien, pledge, hypothecation, mortgage, security interest, claim, lease,
charge, option, right of first refusal or first offer, easement, servitude,
transfer restriction, voting requirement or any other encumbrance, restriction
or limitation on any of the properties or assets of the Licensor, in
30
the case of clauses (ii) and (iii), except for such conflicts, violations,
breaches, or defaults which, individually or in the aggregate, would not
reasonably be likely to have a material adverse effect (A) on the Licensor's
business, financial condition or results of operations or on its ability to
enter into, or perform its obligations under, this Agreement or (B) on the
rights of the Company hereunder or the Company's ability to sell or sublicense
the Licensed Products (a "Material Adverse Effect").
17.3 No consent, approval or authorization of, or declaration or filing
with, any Governmental Authority or Person (a "Consent") is required on the part
of the Licensor in connection with its execution, delivery and performance of
this Agreement or the consummation of the transactions contemplated hereby.
17.4 No written communication has been received by the Licensor, and no
investigation, regulatory enforcement action (including seizure, injunction,
civil penalty or criminal action) or any related Governmental Authority review
is or, in respect of any Licensed Product, to the knowledge of the Licensor, was
at any time pending or is threatened by any Governmental Authority with respect
to (i) any alleged or actual violation by the Licensor of any permit, Law or
other requirement of any Governmental Authority relating to the operations
conducted by the Licensor with respect to any Licensed Product or (ii) any
alleged or actual failure to have or maintain in effect all permits required in
connection with the operations conducted by the Licensor with respect to any
Licensed Product. The Licensor has not received from the Federal Drug
Administration ("FDA"), the U.S. Drug Enforcement Administration ("DEA") or any
similar state, local or foreign Governmental Authority any written notice
regarding the approvability or approval of any of the Licensed Products, except
as set forth in Schedule 17.4. Except for the NEUPREX(R) product in the
meningococcemia and trauma indications, no Licensed Product has been withdrawn,
suspended or discontinued by the Licensor as a result of any action by the FDA,
the DEA or any similar state, local or foreign Governmental Authority, either
within or outside the U.S. (whether voluntarily or otherwise). With respect to
any Licensed Products only, no officer, employee or, to the knowledge of the
Licensor, agent of the Licensor has made any untrue statement of a material fact
or a fraudulent statement to the FDA, DEA or any similar state, local or foreign
Governmental Authority, failed to disclose any material fact required to be
disclosed to the FDA, the DEA or any similar state, local or foreign
Governmental Authority, or committed an act, made a statement or failed to make
a statement that, at the time such act, statement or omission was made, could
reasonably be expected to provide a basis for the FDA, the DEA or any similar
state, local or foreign Governmental Authority to invoke the FDA's policy
respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal
Gratuities" set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar
policy, nor has any director, officer, employee or, to the knowledge of the
Licensor, agent of the Licensor been convicted of any crime or engaged in any
conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) (or any
similar Law) or authorized by 21 U.S.C. Section 335a(b) (or any similar Law).
17.5 There are no suits or actions, administrative, arbitration or other
proceedings, or governmental investigations pending or, to the knowledge of the
Licensor, threatened against or affecting the Licensor with respect to the
Licensed Products. No Entity has notified the Licensor in writing of any
material claim against the Licensor alleging any personal
31
property or economic injury, loss or damage incurred as a result of or relating
to the use of the Licensed Products. There is no judgment, order, injunction,
decree, writ or award against the Licensor that is not satisfied and remains
outstanding with respect to any Licensed Product.
17.6 Schedule 17.6 hereto sets forth a true and complete list of each
material license, contract or other agreement (together with certain other
agreements) to which the Licensor is a party or by or to which any property of
the Licensor is otherwise bound or subject that relates to the Licensed Products
or the Patent Rights (collectively, the "Material Agreements"), including,
without limitation, the Existing Licenses and any material CT Agreements. True
and complete copies of all Material Agreements have been previously delivered to
the Company or, in the case of the CT Agreements, have been made available for
review and copying by the Company and its agents. Each of the Material
Agreements is valid, binding and in full force and effect, and enforceable by
the Licensor, or has expired, in each case in accordance with its respective
terms. No Person (other than the Licensor) that is a party to any Material
Agreement or is otherwise bound thereby is, to the knowledge of the Licensor, in
default or breach thereof and, to the Licensor's knowledge, no event, condition
or act exists that, with the giving of notice or the lapse of time or both,
would give rise to such a default or breach thereof or a right of cancellation
by the Licensor thereunder. The Licensor is not in default or breach in any
material respect of any of the Material Agreements and, to the knowledge of the
Licensor, no event, condition or act exists that, with the giving of notice or
the lapse of time or both, would give rise to a default or breach by the
Licensor thereof or a right of cancellation thereunder by any other party
thereto. For the purposes of this Section 17.6, the term "material" shall mean
having any ongoing effect on any Licensed Product or Patent Rights.
17.7 Except as provided in the documents set forth on Schedule 17.6, the
Licensor has all right, title, and interest in and to the Patent Rights,
Licensed Products, Licensed Processes and Know-how (including the exclusive,
absolute, irrevocable right, title and interest thereto), free and clear of all
liens, charges, encumbrances or other restrictions or limitations of any kind
whatsoever material to the uses of the Patent Rights, Licensed Products and
Know-how. Except as provided in the Material Agreements, there are no
restrictions on the direct or indirect transfer of any contract or other
agreement, or any interest therein, held by the Licensor in respect of any of
the Patent Rights and Know-how.
17.8 To the knowledge of the Licensor, none of the Patent Rights, Licensed
Products or Licensed Processes infringes or conflicts in any material respect
with, and the Licensor has not received any notice of infringement of, or
conflict with, any license, patent, copyright, trademark, service xxxx or other
intellectual property right of any other Entity and, to the knowledge of the
Licensor, there is no infringement or unauthorized use by any person of any of
the Patent Rights, Licensed Products or Licensed Processes. Except as set forth
on Schedule 17.8, the validity or enforceability of any of the Patent Rights,
Licensed Products and Licensed Processes and or the title of the Licensor
thereto has not been questioned in any litigation, governmental inquiry or
proceeding to which the Licensor is a party and, to the knowledge of the
Licensor, no such litigation, governmental inquiry or proceeding is threatened.
17.9 The U.S. and foreign patent applications and patents itemized on
Exhibit A set forth all of the patents and patent applications relating to and
necessary for the
32
development, sublicensing and/or sale of Licensed Products in the Field of Use
owned by, or licensed to, the Licensor as of the date of this Agreement. There
are no inventors of Patent Rights other than those listed as inventors on the
patent filings and, to the knowledge of the Licensor, each of the Patent Rights
is valid and enforceable. The Licensor has complied with its duty of disclosure
to the U.S. Patent and Trademark Office regarding each of such patents in all
material respects.
17.10 To the knowledge of the Licensor, the Licensor has taken all
reasonable actions necessary or appropriate to preserve the confidentiality of
all trade secrets, proprietary and other confidential information material to
the Licensed Products and Patent Rights.
17.11 The Licensor is party to numerous clinical trial agreements that
relate to Licensed Products ("CT Agreements") with physicians, care facilities,
hospitals and contract research organizations to organize and carry out clinical
trials. The parties acknowledge that, by this Agreement, the Licensor is not
assigning, and the Company is not assuming, any indemnification or other
obligations under the CT Agreements and that all liabilities and obligations
under the CT Agreements shall be the sole responsibility of the Licensor. The
Licensor has provided to the Company a copy of each written notice of invention,
if any, received by the Licensor or its Affiliates under any of the CT
Agreements.
17.12 The Licensor has received, by irrevocable assignment for adequate
consideration effective prior to the date of this Agreement, from its Affilates
(including XOMA Tech) the exclusive right to license any Technology, Patent
Rights and Licensed Products covered by the Existing Licenses. The Licensor has
the sole power and authority (to the exclusion of all of its Affiliates) to
sublicense to the Company any Technology, Patent Rights and Licensed Products
covered by the Existing Licenses.
17.13 The portions of the NYU Amendment, the Incyte Amendment and the
Xxxxxx Amendment that have been redacted from Exhibits C-1, D-1 and E,
respectively, represent changed economic terms more favorable to the Licensor
than the comparable terms of the NYU License Agreement, the Incyte License
Agreement and the Xxxxxx License Agreement, as the case may be, prior to being
amended thereby.
ARTICLE 18
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
The Company represents and warrants to the Licensor, as of the date of this
Agreement, that:
18.1 The Company is a corporation duly organized, validly existing and in
good standing under the laws of the State of Delaware. The Company has the
requisite corporate power and authority to execute and deliver this Agreement
and the other agreements contemplated hereby to which it is a party and to
consummate the transactions contemplated hereby and thereby. The execution and
delivery of this Agreement and the other agreements
33
contemplated hereby to which the Company is a party and the performance and
consummation of the transactions contemplated hereby and thereby by the Company
have been duly authorized by all necessary corporate action on the part of the
Company. This Agreement and the other agreements contemplated hereby to which
the Company is a party have been duly executed and delivered by the Company and,
subject to the due authorization, execution and delivery of such agreements by
the other parties thereto, this Agreement and such other agreements contemplated
hereby constitute valid and binding obligations of the Company, enforceable
against the Company in accordance with their respective terms, except as such
enforcement may be affected by bankruptcy, reorganization, insolvency,
moratorium or similar laws affecting creditor's rights generally and except for
general principles of equity.
18.2 The execution and delivery of this Agreement and the other agreements
contemplated hereby do not, and the consummation of the transactions
contemplated hereby and thereby will not, (i) conflict with, or result in any
violation or breach of any provision of the certificate of incorporation or
bylaws of the Company, (ii) conflict with or violate any applicable Laws of any
U.S. Federal, state, foreign or local government or any court, tribunal,
administrative agency or commission or other Governmental Authorities applicable
to the Company or any of its assets or operations or any permit applicable to
the Company or (iii) result in (x) any violation or breach of, constitute (with
or without notice or lapse of time or both) a default under or conflict with (or
give rise to a right of termination, amendment, cancellation or acceleration of
any material obligation or loss of any benefit under) the provisions of any
lease, contract or other agreement to which the Company is a party or by which
it or any of its properties or assets is otherwise bound or (y) the imposition
of any lien, pledge, hypothecation, mortgage, security interest, claim, lease,
charge, option, right of first refusal or first offer, easement, servitude,
transfer restriction, voting requirement or any other encumbrance, restriction
or limitation on any of the properties or assets of the Company.
18.3 No Consent is required on the part of the Company in connection with
its execution, delivery and performance of this Agreement or the consummation of
the transactions contemplated hereby.
ARTICLE 19
MISCELLANEOUS PROVISIONS
19.1 This Agreement shall be construed, governed, interpreted and applied
in accordance with the laws of the State of New York, without regard to
principles of conflicts of laws.
19.2 If this Agreement or any associated transaction is required by the law
of any nation to be either approved or registered with any governmental agency,
the Company shall assume all legal obligations to do so and the costs in
connection therewith.
19.3 The parties hereto acknowledge that this Agreement, including the
Appendices and documents incorporated by reference, sets forth the entire
agreement and understanding of the parties hereto as to the subject matter
hereof, and shall not be subject to any
34
change of modification except by the execution of a written instrument
subscribed to by the parties hereto.
19.4 The provisions of this Agreement are severable, and in the event that
any provision of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.
19.5 The failure of either party to assert a right hereunder or to insist
upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
19.6 The headings of the several articles are inserted for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
19.7 This Agreement will not be binding upon the parties until it has been
signed below on behalf of each party, in which event, it shall be effective as
of the date recited on page one.
19.8 This Agreement embodies the entire understanding of the parties and
shall supersede all previous communications, representations or understandings,
either oral or written, between the parties relating to the subject matter
hereof.
19.9 Neither party shall be liable for delays or nonperformance of this
Agreement if such delay or nonperformance was caused by: (i) act of God, act of
war, strike, fire, natural disaster, terrorism, quarantine or accident; (ii)
lack of availability of materials, fuel or utilities; or (iii) any other cause
beyond such party's control (provided that the required acts of the Non-Licensor
Patent Owners shall not be an act beyond the Licensor's control for purposes of
this Section 19.9).
19.10 For the purposes of this Agreement and all claims, disputes, or
controversies arising from this Agreement (other than as provided in Section 8.1
above), the parties submit to the exclusive jurisdiction of the state and
federal courts located in the Southern District of the State of New York.
35
IN WITNESS WHEREOF, the parties hereto have executed this Agreement, in
triplicate by proper persons thereunto duly authorized.
ZEPHYR SCIENCES INC. XOMA Ireland Limited
By: __________________________ By: _____________________________
Name: _______________________ Xxxx Xxxx
Title: ________________________ Director
Date: ________________________
duly authorized for and on behalf of
XOMA Ireland Limited in the presence of:
_________________________________
36
EXHIBIT A
Patent Rights
Tab 1
Title: BPI-Immunoglobulin Fusion Proteins
Inventors: Theofan, Grinna, Xxxxxxx
Based on PCT/US93/04754 [WO93/23434] which corresponds to U.S. Application No.
08/064,693 filed May 19, 1993.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/064,693 5,643,570
United States 08/885,366 6,274,348
[*]
37
Tab 2
Title: Improved Methods for the Preparation to Endotoxin-Binding Protein
Inventors: Grinna
Based on PCT/US93/04752 [WO93/23540] which corresponds to U.S. Application No.
08/072,063 filed May 19, 1993.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/072,063 5,439,807
[*] [*] [*]
Canada 2,136,208 2,136,208
Canada 2,276,548 2,276,648
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Japan 6-503617 0000000
Xxxxx (Div) 2002-300374 Pending
[*]
38
Tab 3
Title: Stable Bactericidal/Permeability-Increasing Protein Products and
Pharmaceutical Compositions Containing the Same
Inventors: Theofan, Horwitz, Burke, Baltaian, Grinna
Based on PCT/US94/01235 [WO94/18323] which corresponds to U.S. Application No.
08/013,801 filed February 2, 1993.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/013,801 5,420,019
[*] [*] [*]
United States 08/430,417 5,674,834
United States 08/466,822 5,827,816
[*] [*] [*]
[*] [*] [*]
United States 09/425,034 6433140
[*] [*] [*]
Australia 61702/94 693,089
Canada 2,155,004 Pending
China 94191672.3 94191672.3
EPO 94908704.3 0689592
Austria 94908704.3 0689592
Belgium 94908704.3 0689592
Denmark 94908704.3 0000000
Xxxxxx 94908704.3 0689592
Germany 94908704.3 69426019.3
Great Britain 94908704.3 0000000
Xxxxxx 94908704.3 0689592
Hong Kong 98115811.8 1014548
Ireland 94908704.3 0000000
Xxxxx 94908704.3 0689592
Luxembourg 94908704.3 0689592
Monaco 94908704.3 0689592
Netherlands 94908704.3 0689592
Portugal 94908704.3 0000000
Xxxxx 94908704.3 94908704.3
Sweden 94908704.3 94908704.3
Switzerland 94908704.3 0689592
EPO (Div) 00103901.5 0000000
Xxxxxx 00103901.5 1013760
Germany 00103901.5 64931995.3
Great Britain 00103901.5 1013760
Ireland 00103901.5 0000000
Xxxxx 00103901.5 1013760
[*] [*] [*]
39
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
Finland 953,658 112367
Finland (Div) 20031199 Pending
[*] [*] [*]
Norway 1995-3033 315705
Norway (Div) 2002-3224 Pending
New Zealand 262284 262284
Japan 6-518210 Pending
Japan (Div) 2003-355706 Pending
Japan 2004-108131 Pending
Korea 703197/95 000000
Xxxxxx 94 1544 196117
So. Africa 94/0703 94/0703
[*]
40
Tab 4
Title: Pharmaceutical Compositions Containing Bactericidal
Permeability Increasing Protein and a Surfactant
Inventors: McGregor, Stubstad, Xxxxx
Based on PCT/US94/01239 [WO94/17819] which corresponds to U.S. Application No.
08/190,869 filed February 2, 1994.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/190,869 5,488,034
United States 08/251,576 5,932,544
United States 08/472,995 5,696,090
United States 08/986,413 5,955,427
United States 09/299,321 6,057,293
United States 09/313,525 6,066,620
United States 09/502,286 6,268,345
United States 09/502,356 6,255,284
[*] [*] [*]
Australia 61330/94 695125
Canada 2,155,005 2,155,005
China 94191355.4 94191355.4
EPO 94907963.6 0000000
Xxxxxx 94907963.6 0682524
Germany 94907963.6 69428521.8
Great Britain 94907963.6 0682524
Austria 94907963.6 E206308
Belgium 94907963.6 0682524
Denmark 94907963.6 0000000
Xxxxxx 94907963.6 3037729
Ireland 94907963.6 000000
Xxxxx 94907963.6 0682524
Luxembourg 94907963.6 0682524
Monaco 94907963.6 0682524
Netherlands 94907963.6 0682524
Portugal 94907963.6 0000000
Xxxxx 94907963.6 94907963.6
Sweden 94907963.6 94907963.6
Switzerland 94907963.6 0682524
Hong Kong 98115456.8 0000000
Xxxxx 6-518123 Pending
Mexico 94 2023 191964
So. Africa 94/1531 94/1531
[*]
41
Tab 4A
Title: Pharmaceutical Compositions Containing Bactericidal
Permeability Increasing Protein and a Lipid Carrier
Inventors: Grinna
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/251,576 5,932,544
United States 09/299,321 6,057,293
United States 09/502,286 6,268,345
42
Tab 5
Title: Therapeutic Uses of BPI Protein Products
Inventors: Little, Xxxxxxx-Xxxxxxx, Parent
Based on PCT US94/02401 [WO 94/20128], which is a continuation-in part of U.S.
Patent Application No. 08/030,644 filed March 12, 1993.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/030,644 5,348,942
[*] [*] [*]
United States 08/415,158 5,639,727
United States 08/435,855 5,807,818
United States 08/466,624 5,837,678
United States 08/466,826 5,854,214
[*] [*] [*]
[*] [*] [*]
Australia 63605/94 684503
Canada 2,157,927 2,157,927
China 94191892.0 94191892.0
[*] [*] [*]
EPO 94910854.2 0690720
Austria 94910854.2 0690720
Belgium 94910854.2 0690720
Denmark 94910854.2 0000000
Xxxxxx 94910854.2 0690720
Germany 94910854.2 69427582.4
Great Britain 94910854.2 0690720
[*] [*] [*]
Hong Kong 98115810.9 1014497
Ireland 94910854.2 0000000
Xxxxx 94910854.2 0690720
Luxembourg 94910854.2 0690720
Monaco 94910854.2 0690720
Netherlands 94910854.2 0690720
Portugal 94910854.2 0000000
Xxxxx 94910854.2 0690720
Switzerland 94910854.2 0690720
Sweden 94910854.2 0690720
[*] [*] [*]
Japan 6-520214 Pending
Mexico 94 1807 205944
New Zealand 263057 263057
New Zealand 500011 Pending
So. Africa 94/1773 94/1773
43
Tab 7
Title: Treatment of Mycobacterial Diseases by Administration of
Bactericidal/Permeability-Increasing Protein Products
Inventors: Xxxxxxx
Based on PCT/US94/02463 [WO94/20129] [*] filed March 12, 1993.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
United States 08/626,646 6,214,789
United States 09/782,642 6,620,785
[*] [*] [*]
Canada 2,157,925 2,157,925
EPO 94910876.5 0690721
Austria 94910876.5 0690721
Belgium 94910876.5 0690721
Denmark 94910876.5 0000000
Xxxxxx 94910876.5 0690721
Germany 94910876.5 69410254.7
Great Britain 94910876.5 0000000
Xxxxxx 94910876.5 0690721
Hong Kong 98111614.6 1010983
Ireland 94910876.5 0000000
Xxxxx 94910876.5 0690721
Luxembourg 94910876.5 0690721
Monaco 94910876.5 0690721
Netherlands 94910876.5 0690721
Portugal 94910876.5 0000000
Xxxxx 94910876.5 94910876.5
Sweden 94910876.5 94910876.5
Switzerland 94910876.5 0000000
Xxxxxx 94 1808 194437
So. Africa 94/1772 94/1772
[*]
44
Tab 10
Title: Method for Quantifying BPI in Body Fluids
Inventors: White, Carroll, Ma
Based on PCT US94/10793 [WO 95/08773] which corresponds to U.S. Patent
Application No. 08/310,961 filed September 22, 1993.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/125,677 5,466,580
United States 08/175,276 5,466,581
United States 08/310,961 5,821,064
United States 09/169,125 6,759,203
Australia 78010/94 697356
Canada 2,172,243 2,172,243
[*] [*] [*]
EPO 94928653.8 0720745
Austria 94928653.8 0720745
Belgium 94928653.8 0720745
Denmark 94928653.8 0000000
Xxxxxx 94928653.8 0720745
Germany 94928653.8 69414871.7
Great Britain 94928653.8 0000000
Xxxxxx 94928653.8 3029150
Hong Kong 98115455.9 1014207
Ireland 94928653.8 0000000
Xxxxx 94928653.8 0720745
Luxembourg 94928653.8 0720745
Monaco 94928653.8 0720745
Netherlands 94928653.8 0720745
Portugal 94928653.8 0000000
Xxxxx 94928653.8 94928653
Sweden 94928653.8 94928653
Switzerland 94928653.8 0720745
[*] [*] [*]
Korea 701474/96 Pending
Mexico 94 7290 210407
New Zealand 274083 274083
So. Africa 94/7393 94/7393
45
Tab 11
Title: Method of Treating Gram-Negative Bacterial Infection By
Administration of Bactericidal/Permeability-Increasing (BPI)
Protein Product and an Antibiotic
Inventors: Xxxxx, Kung
Based on PCT/US94/11225 [WO95/08344] which corresponds to U.S. Application No.
08/311,611 filed September 22, 1994.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
United States 08/311,611 5,523,288
United States 08/657,162 6,140,306
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Australia 80740/94 695814
Canada 2,172,245 2,172,245
EPO 94931793.7 0759774
Austria 94931793.7 0759774
Belgium 94931793.7 0759774
Denmark 94931793.7 0000000
Xxxxxx 94931793.7 0759774
Germany 94931793.7 69430823.4
Great Britain 94931793.7 0000000
Xxxxxx 94931793.7 3040717
Hong Kong 98115454.0 1014155
Ireland 94931793.7 0000000
Xxxxx 94931793.7 0759774
Luxembourg 94931793.7 0759774
Monaco 94931793.7 0759774
Netherlands 94931793.7 0759774
Portugal 94931793.7 0000000
Xxxxx 94931793.7 94931793.7
Sweden 94931793.7 94931793.7
Switzerland 94931793.7 0000000
Xxxxx 7-509977 Pending
Mexico 94 7310 Pending
New Zealand 275205 275205
New Zealand 329583 329583
So. Africa 94/7394 94/7394
*Cases abandoned in favor of a continuing application.
46
Tab 12
Title: Method of Treating Depressed Reticuloendothelial System Function
Inventors: van Leeuwan, Xxxxxxxxxxx
Based on PCT/US94/11404 [WO95/10297] [*] filed October 5, 1994.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
United States 09/689,097 6,686,332
[*] [*] [*]
Canada 2,173,611 2,173,611
EPO 94930656.7 000000
Xxxxxxx 94930656.7 722333
Belgium 94930656.7 722333
Denmark 94930656.7 000000
Xxxxxx 94930656.7 000000
Xxxxxxx 94930656.7 722333
Great Britain 94930656.7 000000
Xxxxxx 94930656.7 722333
Hong Kong 98115812.7 Pending
Ireland 94930656.7 000000
Xxxxx 94930656.7 000000
Xxxxxxxxxx 94930656.7 722333
Monaco 94930656.7 000000
Xxxxxxxxxxx 94930656.7 722333
Portugal 94930656.7 000000
Xxxxx 94930656.7 94930656.7
Sweden 94930656.7 94930656.7
Switzerland 94930656.7 722333
[*] [*] [*]
So. Africa 94/7783 94/7783
[*]
47
Tab 14
Title: Human Therapeutic Uses of BPI Protein Products
Inventors: Friedmann, Scannon, van Deventer, von der Mohlen, Xxxxx
Based on PCT/US95/01151 [WO95/19784] which corresponds to U.S. Application No.
08/378,228 filed January 24, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/291,112 5,643,875
United States 08/378,228 5,753,620
United States 09/081,166 5,952,302
United States 09/388,758 6,191,112
United States 09/733,613 6,586,400
[*] [*] [*]
Australia 16944/95 703728
Canada 2,181,816 2,181,816
[*] [*] [*]
EPO 95908723.0 Pending
EPO (Div) 01121005.1 Pending
[*] [*] [*]
Hong Kong 02104223.9 Pending
[*]
48
Tab 15
Title: Therapeutic Uses of Bactericidal/Permeability-Increasing
Protein Dimer Products
Inventors: Xxxxxx, Little
Based on PCT/US95/03125 [WO95/24209] which corresponds to U.S. Application No.
08/704,504 filed March 13, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/212,132 5,447,913
United States 08/470,366 5,703,038
United States 08/704,504 5,856,302
United States 09/223,342 6,277,821
Australia 19969/95 703134
Canada 2,185,155 2,185,155
EPO 95913668.0 0749317
Austria 95913668.0 0749317
Belgium 95913668.0 0749317
Denmark 95913668.0 0000000
Xxxxxx 95913668.0 0749317
Germany 95913668.0 69527049.4
Great Britain 95913668.0 0000000
Xxxxxx 95913668.0 0749317
Hong Kong 98115460.2 1014159
Ireland 95913668.0 0000000
Xxxxx 95913668.0 0749317
Luxembourg 95913668.0 0749317
Monaco 95913668.0 0749317
Netherlands 95913668.0 0749317
Portugal 95913668.0 0000000
Xxxxx 95913668.0 95913668.0
Sweden 95913668.0 95913668.0
Switzerland 95913668.0 0749317
[*] [*] [*]
49
Tab 16
Title: Method of Treating Conditions Associated with Intestinal
Ischemia/Reperfusion
Inventors: Xxxxxx, Xxxxxxxx
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/232,527 5,578,568
United States 08/756,164 6,017,881
United States 09/416,828 6,767,893
50
Tab 17
Title: Anti-Gram-Positive Bacterial Methods and Materials
Inventors: Horwitz, Lambert, Little
Based on PCT/US95/00656 [WO95/19180] which corresponds to U.S. Application No.
08/372,783 filed January 13, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/372,783 5,578,572
[*] [*] [*]
United States 08/758,116 5,783,561
United States 09/119,263 6,054,431
[*] [*] [*]
Australia 16822/95 703192
Canada 2,181,164 Pending
EPO 95908545.7 0754050
Austria 95908545.7 0754050
Belgium 95908545.7 0754050
Denmark 95908545.7 0000000
Xxxxxx 95908545.7 0754050
Germany 95908545.7 69527195.4
Great Britain 95908545.7 0000000
Xxxxxx 95908545.7 0754050
Hong Kong 98115461.1 1014160
Ireland 95908545.7 0000000
Xxxxx 95908545.7 0754050
Luxembourg 95908545.7 0754050
Monaco 95908545.7 0754050
Netherlands 95908545.7 0754050
Portugal 95908545.7 0000000
Xxxxx 95908545.7 95908545.7
Sweden 95908545.7 95908545.7
Switzerland 95908545.7 0000000
Xxxxx 7-519190 Pending
So. Africa 95/0249 95/0249
[*]
51
Tab 18
Title: Anti-Fungal Methods and Materials
Inventors: Little, Lim, Scannon, Xxxxxxx
Based on PCT US95/00498 [WO 95/19179] [*]
COUNTRY APPLICATION NO. STATUS/PATENT NO.u
------- --------------- ------------------
[*] [*] [*]
United States 08/372,105 5,627,153
Australia 16797/95 703211
Canada 2,181,165 Pending
China 95191676.9 95191676.9
EPO 95908502.8 0000000
Xxxxxx 95908502.8 0754049
Germany 95908502.8 69526216.5
Great Britain 95908502.8 0754049
Hong Kong 98115459.5 1014158
Ireland 95908502.8 0754049
Switzerland 95908502.8 0000000
Xxxxx 7-519144 Pending
Korea 703773/96 Pending
Mexico 96/02570 195391
[*] [*] [*]
52
Tab 19
Title: Anti-Protozoan Methods and Materials
Inventors: Xxxxxxx
Based on PCT/US95/08624 [WO96/01647] which corresponds to U.S. Application No.
08/273,470 filed July 11, 1994.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/273,470 5,646,114
United States 08/888,876 6,013,629
United States 09/416,118 6,271,203
United States 09/878,546 6,440,936
Canada 2,194,895 Status Pending
EPO 95925597.7 Status Pending
Great Britain 95925597.7 Status Pending
Hong Kong 98115458.6 Status Pending
Ireland 95925597.7 Status Pending
Japan 8-504455 Status Pending
So. Africa 95/5740 Status Pending
53
Tab 20
Title: Therapeutic Compositions Comprising BPI protein products
Inventors: Xxxxxxx
Based on PCT/US96/01095 [WO96/21436] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
United States 08/586,133 5,912,228
[*] [*] [*]
[*] [*] [*]
Australia 47705/96 717640
Canada 2,210,390 Pending
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Japan 8-521883 Pending
54
Tab 21
Title: Method of Treating Conditions Associated with Burn Injuries
Inventors: Hansbrough
Based on PCT US96/02349 [WO 96/30037] which corresponds to U.S. Application No.
08/414,924 filed March 31, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/414,924 5,494,896
[*] [*] [*]
55
Tab 23
Title: Methods of Treating Conditions Associated with Corneal Injury
Inventors: Scannon
Based on PCT US96/18632 [WO 97/17990] [*] filed November 14, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Australia 10215/97 730307
Canada 2,235,626 2,235,626
[*] [*] [*]
[*] [*] [*]
Japan 9-519166 Pending
56
Tab 24
Title: Methods of Treating Conditions Associated with Corneal
Transplantation
Inventors: Scannon
Based on PCT US96/18416 [WO 97/17989] which corresponds to U.S. Application No.
08/557,287 filed November 14, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/557,287 5,686,414
Australia 77361/96 730303
Canada 2,235,625 2,235,625
[*] [*] [*]
Hong Kong 99100829.9 Pending
Japan 9-519125 Pending
57
Tab 25
Title: Methods for Recombinant Microbial Production of Fusion
Proteins and BPI Derived Peptides
Inventors: Better
Based on PCT US97/05287 [WO 97/24297] which corresponds to U.S. Application No.
08/621,803 filed March 18, 1997.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/621,803 5,851,802
United States 09/217,352 6,274,344
[*] [*] [*]
Australia 24297/97 732,475
Canada 2,249,180 2,249,180
[*] [*] [*]
Hong Kong 00000000.0
Japan 9-533802 Pending
58
Tab 26
Title: Therapeutic Uses of BPI Protein Products for Human
Meningococcemia
Inventors: Xxxxxx, Scannon
Based on PCT/US97/08016 [WO97/42966] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/927,437 5,888,977
United States 09/203,159 5,990,086
United States 09/365,858 6,242,418
United States 09/728,938 6,596,691
[*] [*] [*]
[*] [*] [*]
Australia 30043/97 735058
Canada 2,253,837 2,253,837
[*] [*] [*]
EPO 97924679.0 0914144
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
France 97924679.0 0914144
Germany 97924679.0 69703689.8
Great Britain 97924679.0 0914144
[*] [*] [*]
Hong Kong 99105126.8 1019856
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Netherlands 97924679.0 0914144
[*] [*] [*]
Spain 97924679.0 0914144
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
New Zealand 332720 332720
New Zealand 505070 Pending
[*]
59
Tab 27
Title: Antithrombotic Materials and Methods
Inventors: White, Xxxxxx
Based on PCT/US97/08017 [WO97/42976] which corresponds to U.S. Application No.
08/644,290 filed May 10, 1996.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/644,290 5,741,779
United States 09/063,465 5,935,930
United States 09/299,319 6,107,280
United States 09/610,785 6,599,881
[*] [*] [*]
Australia 30044/97 735318
Canada 2,253,836 Pending
[*] [*] [*]
[*] [*] [*]
Hong Kong 99105772.5 Pending
[*] [*] [*]
[*] [*] [*]
60
Tab 28
Title: Therapeutic Uses of BPI Protein Products for Humans with
Hemorrhage Due to Trauma
Inventors: Scannon, Xxxxx
Based on PCT/US97/08941 [WO97/44056] which corresponds to U.S. Application No.
08/862,785 filed May 23, 1997.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/862,785 5,945,399
United States 08/927,438 5,756,464
[*]
61
Tab 29
Title: Anti-Chlamydial Methods and Materials
Inventors: Xxxxxxx
Based on PCT/US97/13810 [WO98/06415] which corresponds to U.S. Application No.
08/694,843 filed August 9, 1996.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/694,843 5,888,973
United States 09/281,985 6,162,788
United States 09/699,625 6,583,116
[*] [*] [*]
Australia 39094/97 Status Pending
Canada 2,263,181 Status Pending
China 97198452.2 Status Pending
EPO 97936420.5 Status Pending
France 97936420.5 Status Pending
Germany 97936420.5 Status Pending
Great Britain 97936420.5 Status Pending
Hong Kong 99105621.8 Status Pending
Switzerland 97936420.5 Status Pending
Japan 10-509836 Status Pending
Mexico 991366 Status Pending
New Zealand 334041 Status Pending
62
Tab 30
Title: Therapeutic Uses of N-Terminal BPI Protein Products in
ANCA-Positive Patients
Inventors: Xxxxxxx
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 09/255,245 6,482,796
[*] [*] [*]
63
Tab 31
Title: Therapeutic Uses of BPI Protein Products in Cystic Fibrosis
Patients
Inventors: Xxxxxxx, Scannon
Based on PCT/US97/19850 [WO98/19694] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
United States 09/255,083 6,482,796
[*] [*] [*]
Australia 51596/98 744918
Canada 2,270,290 Pending
EPO 97946427.8 0000000
Xxxxxx 97946427.8 0938331
Germany 97946427.8 69718047.6
Great Britain 97946427.8 0938331
Ireland 97946427.8 0938331
[*] [*] [*]
Hong Kong 00100900.9 Pending
Japan 10-521605 Pending
New Zealand 335401 335401
[*]
64
Tab 32
Title: Three Dimensional Structure of Bactericidal/Permeability
Increasing Protein (BPI)
Inventors: Beamer, Carroll, Xxxxxxxxx
Based on PCT US97/13007 [WO 98/58961] which is a continuation-in-part
application of U.S. Application No. 08/879,565, filed June 20, 1997
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/879,565 6,093,573
United States 09/446,415 Status Pending
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Australia 84722/98 Status Pending
Canada 2,293,999 Status Pending
[*] [*] [*]
Japan 11-504967 Pending
65
Tab 35
Title: Bactericidal/Permeability Increasing (BPI) Protein Deletion
Analogs
Inventors: Horwitz, Carroll, Xxxxx
Based on PCT/US99/1386 [WO99/66044] which corresponds to U.S. Application No.
09/336,402 filed June 18, 1999.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/099,725 6,013,631
United States 09/336,402 6,087,126
United States 09/579,403 6,599,880
[*] [*] [*]
Australia 46976/99 755624
Canada 2,331,880 Pending
[*] [*] [*]
Hong Kong 01106701.6 Pending
Japan 2000-554855 Pending
China 99809726.8 Pending
Mexico 2000/011398 Status Pending
New Zealand 508816 Pending
66
Tab 36
Title: Identification of Novel Antimicrobial Agents using Membrane
Potential Indicator Dyes
Inventors: Little, Abrahamson, Xxxx
Based on PCT/US99/22361 [WO0/18951] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
United States 09/404,926 6,143,516
United States 09/626,995 6,455,271
Australia 61644/99 Pending
Canada 2344676 Pending
Great Britain 01096825 2361316
67
Tab 38
Title: Method of Treating Chronic Cardiac Disease
Inventors: Xxxxxx, Scannon
Based on PCT US00/01515 [WO 00/43028] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/488,979 6,509,317
[*] [*] [*]
[*] [*] [*]
Xxxxxxxxx 00000/00 Xxxxxxx
Xxxxxx 2,359,681 Pending
Japan 2000-594481 Pending
China 008051151.1 Pending
Mexico 2001/00731 Pending
New Zealand 513087 513087
EPO 00905696.1 1143996
Belgium 00905696.1 0000000
Xxxxxx 00905696.1 1143996
Germany 00905696.1 60002552.7
Great Britain 00905696.1 1143996
Hong Kong 02102817.5 Pending
Ireland 00905696.1 1143996
Monaco 00905696.1 1143996
Switzerland 00905696.1 1143996
68
Tab 40
Title: Therapeutic Uses of BPI Protein Products in BPI-Deficient
Humans
Inventors: Levy
Based on PCT US00/08864 [WO 00/59531] which corresponds to U.S. Application No.
09/285,124 filed April 1, 1999
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/285,124 6,153,584
United States 09/541,821 6,376,465
[*] [*] [*]
Xxxxxxxxx 00000/00 Xxxxxxx
Xxxxxx 2,367,943 2,367,943
[*] [*] [*]
Hong Kong 02105068.4 Pending
69
Tab 41
Title: Therapeutic Uses of BPI Protein Products in Humans with
Otitis Media with Effusion
Inventors: Xxxxx, Xxxx
Based on PCT US00/14496 [WO 00/71149] [*] filed May 24, 1999.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/586,850 6,670,327
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Australia 52923/00 Pending
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
70
[*]
71
[*]
72
Tab 47
Title: Agents and Methods for Inhibiting F1/F0 ATPase
Inventors: Little, Xxxxxxxxxx
Based on PCT US00/09137 [WO01/04347] [*] filed July 12, 1999.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 09/545,112 6,376,211
[*] [*] [*]
Canada 2,379,119 Pending
73
Tab 48
Title: Identification of Novel Antimicrobial Agents using Metabolic
Oxidation - Reduction Indicator Dyes
Inventors: Little
Based on PCT US00/09116 [WO01/04346] [*] filed July 12, 1999.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
[*] [*] [*]
United States 09/543,955 6,436,660
Canada 2,379,118 Pending
74
Tab 51
Title: Modulation of Pericyte Proliferation
Inventors: King, Abrahamson, Xxxxxxx
Based on PCT US01/46609 [WO 02/055099] which claims benefit under 35 USC
ss.119(e) of U.S. Provisional Application No. 60/250,542 filed December 1, 2000.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
Australia 2002241589 Pending
Canada 2,430,588 Pending
[*] [*] [*]
Japan 2002-555833 Pending
75
NYU
Title: Biologically Active Bactericidal/Permeability-Increasing
Protein Fragments
Inventors: Elsbach, Xxxxx (New York University)
Based on PCT/US88/02700 [WO 89/01486] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
United States 07/801,814 6,132,775
United States 07/805,031 5,198,541
[*] [*] [*]
United States 08/007,837 5,641,874
United States 08/023,760 5,489,676
United States 08/173,968 5,576,292
United States 08/361,299 5,948,408
[*] [*] [*]
[*] [*] [*]
United States 08/478,063 5,980,897
United States 09/309,217 6,287,811
United States 09/866,514 6,652,862
[*] [*] [*]
Xxxxxxxxx 00000/00 Xxxxxxx
Xxxxxx 2,574,398 Pending
[*] [*] [*]
Europe 88907884.6 0375724
Austria 88907884.6 Status Pending
Belgium 88907884.6 0000000
Xxxxxx 88907884.6 0375724
Germany 88907884.6 3853918.7
Great Britain 88907884.6 0000000
Xxxxx 88907884.6 Xxxxxx Xxxxxxx
Xxxxxxxxxx 00000000.0 Xxxxxx Xxxxxxx
Xxxxxxxxxxx 88907884.6 0375724
Sweden 88907884.6 Status Pending
Switzerland 88907884.6 0375724
[*] [*] [*]
Europe 92902215.0 0000000
Xxxxxx 92902215.0 0563222
Great Britain 92902215.0 0563222
76
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
Germany 92902215.0 00000000.9
Japan 63-507146 0000000
Xxxxx 11-331278 3086685
[*]
77
INCYTE 11300
Title: Use of Bactericidal/Permeability Increasing Protein or
Biologically Active Analogs Thereof to Treat
Lipopolysaccharide Associated Gram Negative Infections
Inventors: Xxxxx, Xxxxx
Based on PCT/US90/00837 [WO 90/09183] [*] filed February 14, 1989.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 07/468,696 5,089,274
Australia 51706/90 647734
Canada 2,048,619 2,048,619
Canada (Divisional) 2,323,630 Pending
EPO 90904068.5 0460058
Belgium 90904068.5 0460058
Denmark 90904068.5 0000000
Xxxxxx 90904068.5 0460058
Germany 90904068.5 69032579.7
Great Britain 90904068.5 0000000
Xxxxx 90904068.5 0460058
Netherlands 90904068.5 0000000
Xxxxx 90904068.5 0460058
EPO 97118279.5 0841064
Belgium 97118279.5 0000000
Xxxxxx 97118279.5 0841064
Germany 97118279.5 69034096.6
Great Britain 97118279.5 0000000
Xxxxx 97118279.5 0841064
Netherlands 97118279.5 0000000
Xxxxx 97118279.5 00000000.5
Japan 504045/90 2966923
Korea 702247/1990 Status Pending
78
INCYTE 11301
Title: Use of Bactericidal/Permeability Increasing Protein or
Biologically Active Analogs Thereof to Treat Lipopolysaccharide
Associated Gram Negative Infections
Inventors: Xxxxx, Xxxxx
Based on PCT/US91/05758 [WO 92/03535] filed August 13, 1990.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 07/681,551 5,171,739
United States 07/990,662 5,308,834
United States 07/990,044 5,334,584
Australia 88501/91 660427
Canada 2,088,496 Pending
Japan 517796/91 Pending
Japan (Div) 2002-108147 0000000
Xxxxx (Div) 2003-317025 Pending
Korea 700379/1993 240385
Korea 7002675 Status Pending
79
INCYTE 11303
Title: Compositions Comprising a Bactericidal/Permeability-Increasing
Protein and a Lipid Carrier, Methods of Making Same, and Uses
Thereof.
Inventors: Xxxxx, Xxxxx
Based on PCT/US92/08234 [WO 93/05797] filed September 27, 1991.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 07/468,696 5,089,274
Australia 51706/90 647734
Canada 2,048,619 2,048,619
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
EPO 97118279.5 0841064
Belgium 97118279.5 0000000
Xxxxxx 97118279.5 0841064
Germany 97118279.5 69034096.6
Great Britain 97118279.5 0000000
Xxxxx 97118279.5 0841064
Netherlands 97118279.5 0000000
Xxxxx 97118279.5 00000000.5
Japan 504045/90 2966923
[*]
80
INCYTE 11301
Title: Use of Bactericidal/Permeability Increasing Protein or
Biologically Active Analogs Thereof to Treat Lipopolysaccharide
Associated Gram Negative Infections
Inventors: Xxxxx, Xxxxx
Based on PCT/US91/05758 [WO 92/03535] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 07/681,551 5,171,739
[*] [*] [*]
United States 07/990,662 5,308,834
United States 07/990,044 5,334,584
Australia 88501/91 660427
Canada 2,088,496 Pending
EPO 00126715.2 Pending
Japan 517796/91 Pending
Japan (Div) 2002-108147 0000000
Xxxxx (Div) 2003-317025 Pending
Korea 700379/1993 240385
[*]
81
INCYTE 11303
Title: Compositions Comprising a Bactericidal/Permeability-Increasing
Protein and a Lipid Carrier, Methods of Making Same, and Uses
Thereof.
Inventors: Xxxxx, Xxxxx
Based on PCT/US92/08234 [WO 93/05797] [*] filed September 27, 1991.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
Australia 26997/92 664206
Canada 2,119,262 2,119,262
EPO 93906309.5 0000000
Xxxxxx 93906309.5 0610445
Germany 93906309.5 69327516.2
Great Britain 93906309.5 0610445
Ireland 93906309.5 0610445
Switzerland 93906309.5 0610445
[*]
82
[*]
83
[*]
84
INCYTE 11306
Title: Glycosylated and Non-Glycosylated Bactericidal/Permeability-
Increasing Protein and Methods for Producing Same.
Inventors: Xxxxx, Xxxxx, Xxxx, Xxxxxx
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
EPO 94921451.4 000000
Xxxxxx 94921451.4 000000
Xxxxxxx 94921451.4 69431923
Ireland 94921451.4 726944
[*] [*] [*]
85
INCYTE 11307
Title: Recombinant Endotoxin-Neutralizing Proteins
Inventors: Xxxxx, Xxxxx
Based on PCT/US96/06134 [WO 96/34873] which corresponds to U.S. Application No.
08/431,517 filed May 1, 1995.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 08/431,517 6,265,187
[*] [*] [*]
[*] [*] [*]
Australia 56358/96 Pending
86
INCYTE 11308
Title: Neutralization of Non-Lipopolysaccharide Compounds by
Bactericidal/Permeability-Increasing Protein
Inventors: Espevik, Xxxxx
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/267,139 5,532,216
87
INCYTE 11309
Title: Genetically Engineered BPI Variant Proteins
Inventors: Xxxxx, Xxxxx
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 07/915,720 5,770,694
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
United States 09/025,543 6,093,801
[*] [*] [*]
88
EXHIBIT B
Tab 6
Title: Biologically Active Peptides from Functional Domains of
Bactericidal/Permeability-Increasing Protein and Uses Thereof
Inventors: Little
Based on PCT US94/02465 [WO94/20532], [*]filed January 14, 1994.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/209,762 5,733,872
[*] [*] [*]
United States 08/473,344 5,763,567
[*] [*] [*]
United States 09/093,539 6,228,834
United States 09/790,230 6,495,516
[*] [*] [*]
Australia 63988/94 694,108
Canada 2,158,058 2,158,058
China 94191894.7 Pending
EPO 94911490.4 0690872B
Austria 94911490.4 0690872B
Belgium 94911490.4 0690872B
Denmark 94911490.4 0690872B
France 94911490.4 0690872B
Germany 94911490.4 69412243.2
Great Britain 94911490.4 0690872B
Greece 94911490.4 0690872B
Hong Kong 98115457.7 1014191
Ireland 94911490.4 0000000X
Xxxxx 94911490.4 0690872B
Luxembourg 94911490.4 0690872B
Monaco 94911490.4 0690872B
Netherlands 94911490.4 0690872B
Portugal 94911490.4 0690872B
Spain 94911490.4 94911490.4
Sweden 94911490.4 94911490.4
Switzerland 94911490.4 0690872B
Mexico 94 00000 Xxxxxxx
Xxx Xxxxxxx 000000 Xxxxxx Xxxxxxx
Xxxxx Xxxxxx 94/1771 00/0000
Xxxxx 6-520251 Pending (8-508248)
United States 08/306,473 5,652,332
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
United States 08/485,445 5,856,438
[*] [*] [*]
United States 09/224,480 6,153,730
[*] [*] [*]
United States 10/446,628 Pending
Australia 79560/94 681,453
Canada 2,181,150 2,181,150
China 94194835.8 94194835.8
PCT US94/10427 Pub. WO95/19372
EPO 94930435.6 0754194B
France 94930435.6 0754194B
Germany 94930435.6 69427546.8
Great Britain 94930435.6 0754194B
[*] [*] [*]
Ireland 94930435.6 0754194B
Switzerland 94930435.6 0754194B
Japan 7-519010 Pending (9-507501)
Mexico 94 7149 Pending
South Africa 94/7133 94/7133
2
Tab 22
Title: Anti-Fungal Peptides
Inventors: Little, Lim, Xxxxx
Based on PCT US95/09262 [WO 96/08509] [*].
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
United States 09/881,490 Pending
Australia 31981/95 709738
Canada 2,200,069 2,200,069
[*] [*] [*]
Hong Kong 98110168.8 Pending
Japan 8-510173 Pending
United States 08/621,259 5,858,974
United States 09/227,659 6,156,730
United States 09/677,664 6,664,231
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
PCT US96/03845 Pub. WO97/04008
[*]
3
[*]
4
Tab 42
Title: Therapeutic Peptide-Based Constructs Derived From Domain II of
Bactericidal/Permeability-Increasing Protein
Inventors: Little, Lin, Gikonyo
Based on PCT/US00/17358 [WO01/00655] which corresponds to U.S. Application No.
09/344,219 filed June 25, 1999.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/344,219 6,515,104
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
Xxxxxxxxx 00000/00 Xxxxxxx
Xxxxxx 2,377,209 Pending
[*] [*] [*]
Japan 2001-518656 Pending
5
Tab 43
Title: Derivative Compounds Derived From or Based On
Bactericidal/Permeability-Increasing Protein
Inventors: Little, Lin, Gikonyo
Based on PCT US00/17383 [WO 01/00671] which corresponds to U.S. Application No.
09/344,541 filed June 25, 1999.
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/344,541 6,355,616
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
6
Tab 44
Title: Therapeutic Derivative Compounds Derived From Domain II of
Bactericidal/Permeability-Increasing Protein
Inventors: Little, Lin, Gikonyo
COUNTRY APPLICATION NO. STATUS/PATENT NO.
------- --------------- -----------------
United States 09/344,827 6,423,825
7
[*]
8
[*]
9
Exhibit C-1
NYU License Agreement Amendment
10
Exhibit C-2
NYU Acknowledgement
ACKNOWLEDGEMENT
Reference is made to the Amended and Restated Research and License
Agreement dated as of September 1, 1993, as amended (the "License Agreement")
between XOMA Corporation and New York University ("NYU") and the Seventh
Amendment to License Agreement dated as of the date hereof (the "Amendment" and,
together with the License Agreement, the "Agreement") among XOMA Technology
Ltd., XOMA Ireland Limited (each a subsidiary of the successor in interest to
XOMA Corporation and collectively "XOMA") and NYU.
NYU hereby acknowledges to Zephyr Sciences Inc. ("Zephyr") that (i) to the
knowledge of its Executive Director, Industrial Liaison/Technology Transfer
without investigation, as of the date hereof, there is no breach or event of
default existing or continuing by XOMA and (ii) Zephyr is an intended third
party beneficiary under the last sentence of Subsection 13.c. of the Agreement.
This acknowledgement shall be governed by and construed in accordance with
the laws of the State of New York, without regard to principles of conflicts of
laws, and may be executed in counterparts and delivered by facsimile
transmission.
11
NEW YORK UNIVERSITY
By:__________________________
Xxxxx X. Xxxxxxxxxx
Executive Director,
Industrial Liaison/
Technology Transfer
Date: _______________________
ACCEPTED and AGREED
as of the date set forth below:
ZEPHYR SCIENCES INC.
By: _____________________
Name:
Title:
Date: ______________________
12
Exhibit D-1
Incyte License Agreement Amendment
Exhibit D-2
Incyte Acknowledgement
Incyte hereby acknowledges to Zephyr Sciences Inc. ("Zephyr") that (i) XOMA has
the right under the Agreement to grant Zephyr an exclusive sublicense with the
ability of Zephyr to sublicense its rights, subject to the terms of Zephyr's
sublicense and the Agreement, (ii) as of the date hereof, there is no breach or
event of default existing or continuing by XOMA, (iii) Zephyr is an intended
third party beneficiary under the Agreement and this Acknowledgement and (iv)
Zephyr shall rely upon the truth and accuracy of this Acknowledgement in
entering into its sublicense from XOMA
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Exhibit E-1
Xxxxxx License Agreement Amendment Terms
So long as a valid sublicense hereunder remains in effect between XOMA Ireland
Limited and Zephyr Sciences Inc. ("Sublicensee"), there shall be no amendment to
the terms or conditions of this Agreement without the prior written consent of
Sublicensee; provided, however, that adjustments in the financial terms
favorable to XOMA may occur without Sublicensee's prior consent (so long as such
adjustment does not diminish or contravene any rights of Sublicensee).
Exhibit X-0
Xxxxxx Xxxxxxxxxxxxxxx
Xxxxxx hereby acknowledges to Zephyr Sciences Inc. ("Zephyr") that (i) XOMA has
the right under the Agreement to grant Zephyr an exclusive sublicense with the
ability of Zephyr to sublicense its rights, subject to the terms of Zephyr's
sublicense and the Agreement, (ii) as of the date hereof, there is no breach or
event of default existing or continuing by XOMA, (iii) Zephyr is an intended
third party beneficiary under the Agreement and this Acknowledgement and (iv)
Zephyr shall rely upon the truth and accuracy of this Acknowledgement in
entering into its sublicense from XOMA.
2
