LICENSE AGREEMENT (as amended)
Exhibit
10.7
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
A complete copy of this document has been filed separately with the Securities
and Exchange Commission.
(as
amended)
THIS
LICENSE AGREEMENT
(hereinafter referred to as this “Agreement”),
effective as of this February 8, 2005 is entered into by and between The
Cleveland Clinic Foundation, an Ohio non-profit corporation located at 0000
Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxx 00000 (the “Licensor”),
and
Greenwich Pharmaceuticals, Inc., a Delaware for-profit corporation located
at
000 Xxxxxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 (the “Company”).
Licensor and Company shall individually be referred to as “Party”
and
collectively referred to as the “Parties.”
WHEREAS,
the
Licensor owns rights to the research, development and commercialization of
intellectual property relating to Sodium Stibogluconate, Pentamidine, analogues
of Sodium Stibogluconate and Pentamidine, pentavalent antimony-based compounds
and other compounds (collectively, the “Technology”)
as
claimed in Patent Rights or covered by Know-How (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 Licensor is willing
to grant such rights 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 (as hereinafter defined), any Entity that
directly or indirectly controls, is controlled by, or is under common control
with such Entity.
1.2 “Control”
shall
mean, for this purpose, 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.
1.3 “Entity”
shall
mean any corporation, association, joint venture, partnership, trust,
university, business, individual, government or political subdivision thereof,
including an agency, or any other organization that can exercise independent
legal standing.
1.4 “Company”
shall
mean Greenwich Pharmaceuticals, Inc., a Delaware corporation.
1.5 “Fair
Market Value”
shall
mean a commercially reasonable price agreed to between a willing buyer and
a
willing seller in an arm’s length transaction.
1.6 “Field
of Use”
shall
mean all uses.
1.7 “Improvements”
shall
mean (i) any modifications of a Licensed Process or Licensed Product developed
by the Licensor after the date of this Agreement; (ii) any invention (whether
patentable or not), information and data developed or discovered after the
date
of this Agreement that the manufacture, use or sale of which would be reasonably
necessary in the manufacturing, use or sale of Licensed Products or Processes
or
would infringe an issued or pending claim within the Patent Rights.
1.8 “Investigator(s)”
shall
mean Taolin Yi, Ph.D., members of his laboratory during their respective
employment by Licensor, and any Licensor employee acting under Xx. Xx’x
direction or control.
1.9 “Know-how”
shall
mean all tangible information (other than those contained in the Patent Rights)
whether patentable or not (but which have not been patented), which are
reasonably necessary to practice the Patent Rights or to sell Licensed Compound,
Licensed Products or practice Licensed Processes, including formulations,
processes and procedures, data, drawings and sketches, in vitro and in vivo
data, animal data, laboratory data, observations, designs, testing and test
results, regulatory information of a like nature, manufacturing processes
developed by Investigators and owned by the Licensor, which Licensor have
the
right to disclose and license to the Company.
1.10 “Licensed
Compound”
shall
mean, separately, (i) Sodium Stibogluconate; (ii) Pentamidine; (iii) each
analogue of Sodium Stibogluconate; (iv) each analogue of Pentamidine, and
(v)
pentavalent antimony-based compounds; provided,
however,
such
compounds in (i)-(v) are covered under the Patent Rights; and (v) any other
compound described in the patent or patent application listed on Exhibit
A.
1.11 “Licensed
Product(s)”
shall
mean:
1.11.1 Any
product that is covered in whole or in part by Patent Rights in the country
in
which the product is made, used, leased or sold;
1.11.2 Any
product which is manufactured using a process which is covered in whole or
in
part by Patent Rights in the country in which the process is used;
1.11.3 Any
product which is used according to a method or use which is covered in whole
or
in part by Patent Rights in the country in which the method is
used.
1.12 “Licensed
Process(es)”
shall
mean any process, use or method, which is covered, in whole, or in part,
by
Patent Rights in the country in which the process or method is
used.
1.13 “Net
Sales”
shall
mean the total gross receipts for sales of Licensed Products or practice
of
Licensed Processes by or on behalf of the Company or any of its Affiliates
or
sublicensees, whether invoiced or not, less only the sum of the
following:
1.13.1 Usual
trade discounts to customers;
1.13.2 Sales,
tariff duties and/or taxes directly imposed and with reference to particular
sales;
1.13.3 Amounts
allowed or credited on returns or rejections;
1.13.4 Licensed
Product or Licensed Process revenues deemed uncollectible and actually written
off during the accounting period; and
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1.13.5 Outbound
transportation prepaid or allowed and transportation insurance.
1.14 “Patent
Rights”
shall
mean all U.S. and foreign patents and patent applications set forth in
Exhibit
A
and:
1.14.1 Any
other
United States and/or foreign patent applications and/or patents filed on
behalf
of the Investigators by CCF and owned by CCF that claim priority to any of
the
patents or applications listed in Exhibit
A,
together with any and all patents issuing thereon, including continuations,
continuations in part, divisionals, reexaminations, extensions, and reissue
applications and continuation-in-part applications and any United States
or
foreign patents granted upon such applications;
1.14.2 U.S.
and
foreign patents and patent applications claiming Improvements developed in
the
first year immediately following the Effective Date of this Agreement including
any continuations, continuations-in-part, divisionals, reissues, reexaminations
or extensions thereof;
1.14.3 Any
United States and/or foreign patents issuing from any application or other
right
listed in this Article 1.14.
1.14.4 Any
patent or patent application owned as of the Effective Date by Licensor claiming
Licensed Compounds or their use or manufacture that that would be reasonably
necessary for the Company to manufacture, use, or sell Licensed Products
or
Licensed Processes.
1.15 “Territory”
shall
mean the world.
ARTICLE
2 - GRANT
2.1 Licensor
hereby grants to the Company and the Company accepts, subject to the terms
and
conditions of this Agreement, an exclusive license in the Field of Use to
practice under the Patent Rights and to utilize the Know-how in the Territory,
and (a) to make, have made, use, lease and/or 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 subsection (a) of this Section 2.1.
Notwithstanding the foregoing, Licensor reserves the right to practice under
the
Patent Rights and utilize the Know-How for its own non-commercial research
and
educational purposes; provided,
however,
the
Licensor shall not conduct any human clinical trials with a Licensed Product
without first receiving written permission from Company.
2.2 In
accordance with Section 2.1 above, 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 such sublicenses shall be in writing.
Within thirty- (30) days after execution or receipt thereof, as applicable,
the
Company shall provide Licensor with a copy of each sublicense issued hereunder.
Upon termination of this Agreement, any sublicensee shall survive such
termination provided that sublicensees agree in writing to fully comply with
the
terms and conditions this Agreement, provided, further, however, that such
sublicensee is in good standing at the time of such termination and that
if such
sublicensee is not in good standing at the time of termination of this
Agreement, the Company shall notify sublicensee of its default and such
sublicensee shall have sixty- (60) days to cure any breach of its sublicense
agreement. Notwithstanding the foregoing, if Company believes that 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.
3
2.3 The
licenses granted in Sections 2.1 may be subject to the rights of the United
States Government as set forth in 35 U.S.C. § 200 et seq. If there is any
conflict between any Government rights and the rights granted herein, such
Government rights shall prevail.
2.4 The
Licensor hereby grants to the Company, and the Company hereby accepts, the
exclusive right to negotiate for a license, on a worldwide basis in all fields
of use, and on commercially reasonable terms, any Improvements developed
on or
after the first anniversary of the Effective Date of this Agreement through
the
end of the Term (hereinafter “Follow-on
Improvements”).
In
the event that Licensor files a U.S. patent application on any Follow-on
Improvements, Licensor shall under confidentiality notify Company of such
Follow-on Improvements prior to discussing a license with any third party.
Company shall have no longer than thirty- (30) days immediately following
the
disclosure of such Follow-on Improvements to notify Licensor in writing of
its
desire to obtain a license to the Follow-on Improvements. Parties shall enter
into good-faith negotiations for a license to the Follow-on Improvements
for a
period of ninety- (90) days. If within such time period, the Parties are
not
able to agree upon a license, Licensor shall have no further obligation to
Company relating to such Follow-on Improvement.
2.5 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 or litigation against the Company based on or alleging that the Company’s
manufacture, use, or sale of Licensed Processes or License Products infringe
on
any rights under any patents or patent applications having the Investigator
as
an inventor and owned by the Licensor as of the Effective Date or (b) enter
into
a license with respect to or otherwise convey rights under, any of the patents
and patent applications listed in Exhibit
A
to any
third party.
2.6 Licensor
shall, to the extent permitted by applicable law and regulations, provide
the
Company with, and/or give the Company access to the following information
specifically pertaining to the research and development of the Technology
to the
extent that such information is reasonably available and accessible to Licensor:
(i) copies of all regulatory submissions by the Licensor, its Affiliates,
contractors or agents, (ii) copies of or access to all patient records and
data
(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, (vii) reasonable storage of and access 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, if any, 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. 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, and materials. 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.
4
ARTICLE
3 - COMMERCIALIZATION
The
Company shall use all 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 a Licensed Product throughout the term of this Agreement.
Company intends to fund and support ongoing research and clinical development
at
CCF, provided however, the Company funded research or clinical trials are
conducted under the direction and control of the Company and such research
and
clinical development is in the best interest of commercially developing the
compounds as determined by the Company in its sole discretion. Should the
Company discontinue such research and clinical development with the Technology
at the Cleveland Clinic, such action shall not be deemed a breach of this
Agreement
ARTICLE
4 - ROYALTIES AND OTHER CONSIDERATION
4.1 In
partial consideration for the License Grant herein, Company will remit to
the
Licensor a non-creditable, non-refundable fee of Five Hundred Thousand Dollars
($500,000)
within
fifteen- (15) days of the Effective Date of this Agreement. Additionally,
the
Company will remit to Licensor [***] Dollars ($[***]) promptly upon execution
of
this Agreement to reimburse Licensor for accountable out of pocket expenses
incurred directly from the filing, prosecuting, and maintaining of the Licensed
Patents accrued prior to the execution of the License Agreement.
4.2 Within
thirty- (30) days immediately following the first anniversary of the License
Agreement and every anniversary thereafter for the duration of the Term,
Company
would pay Licensor Thirty Five Thousand Dollars ($35,000)
(the
“Maintenance
Fee”).
Maintenance Fees will be fully creditable against Earned Royalties payable
pursuant to Section 4.1 and Milestone Payments due Licensor within the twelve-
(12) months immediately following each payment.
4.3 As
further consideration for the license granted hereunder, the Company will
make
the following one-time milestone payments (each a “Milestone
Payment”)
to
Licensor. The Company will not pay the same milestone twice on any Licensed
Product containing a Licensed Compound already developed by the Company.
For
clarity, should the Company develop a Licensed Product containing Pentamidine,
it would not have to pay the Milestone Payment listed below for the development
of a subsequent Licensed Product containing Pentamidine, but would only be
obligated to pay the Milestone Payment below if such subsequent Licensed
Product
contains an active ingredient other than Pentamidine and that is not present
in
a prior Licensed Product. Payments made pursuant to this Section 4.5 shall
be
credited against Earned Royalties payable pursuant to Section 4.1 and accrued
for the same Licensed Product within the twelve (12) months immediately
following the payment of such Milestone Payment. Accordingly, the Company
shall
remit to the Licensor:
4.3.1 [***]
Dollars ($[***]) upon the first dosing of a patient, with a Licensed Product,
in
the first Phase II clinical trial (or if in a country other than the United
States, a regulatory equivalent of a Phase II Clinical Trial) under a
Company-sponsored (or sublicensee-sponsored) Investigational New Drug
Application (an “IND”)
for
such Licensed Product;
4.3.2 [***]
Dollars ($[***]) upon the first dosing of a patient, with a Licensed Product,
in
the first Phase III clinical trial (or if in a country other than the United
States, a regulatory equivalent of a Phase III Clinical Trial) under a Company
sponsored (or sublicensee sponsored) IND for such Licensed Product;
5
4.3.3 [***]
Dollars ($[***]) upon the acceptance for review a Company sponsored (or
sublicensee sponsored) New Drug Application (an “NDA”)
by the
United States Food and Drug Administration (the “FDA”)
for
such Licensed Product (or if in a country other than the United States, that
countries regulatory equivalent on an NDA); and
4.3.4 [***]
Dollars ($[***]) upon the final approval by the FDA of a Company-sponsored
(or
sublicensee-sponsored) NDA for such Licensed Product filed by the Company
or its
sublicensee (or if in a country other than the United States, that countries
regulatory equivalent of an NDA).
For
clarity, one time payments due to the Licensor in Sections 4.3.1-4.3.4 above
shall be due on the first to occur of a United States and foreign clinical
event
(as applicable), but in no case both. The Company shall be responsible for
notifying Licensor in writing of achievement of the milestones listed above
within ten- (10) business days of their occurrence and Milestone Payments
shall
be due within thirty- (30) days following such written
notification.
4.4 During
the Term, the Company shall pay to the Licensor royalties equal to [***]
percent
([***]%) of annual Net Sales by the Company or its sublicensees resulting
from
the sale of any Licensed Product by the Company or its sublicensees to an
end
user (hereinafter “Earned
Royalty”).
4.5 No
multiple Earned 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.
4.6 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 that includes one or more Licensed Products, the Net
Sales
for such combination product upon which the royalty due to Licensor is based
shall not be less than the normal aggregate Net Sales for such Licensed Product.
In no event shall Licensor’s Earned Royalty be calculated on a pro rata
contribution to a combination product of less than [***] percent ([***]%)
of the
Net Sales.
4.7
Royalty
payments shall be paid in United States dollars at such place as Licensor
may
reasonably designate consistent with the laws and regulations controlling
in the
United States and if applicable in any foreign country. If Company is required
by law, rule or regulation to withhold taxes from the types of payment due
Licensor hereunder, the parties shall (a) deduct those taxes from the amount
otherwise remittable to Licensor hereunder, (b) pay such taxes to the proper
taxing authority, and (c) send evidence of the obligation together with proof
of
payment to Licensor within fifteen- (15) business days following that payment.
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.
6
4.8 Royalties
payable to Licensor shall be paid quarterly on or before March 30, June 30,
September 30, and December 31 of each calendar year. Each such payment shall
be
for unpaid royalties that accrued within or prior to the Company’s most recently
completed fiscal quarters.
4.9 No
Earned
Royalty obligations shall be due with respect to any sale or sublicense covering
any Licensed Product in a country if there are no Patent Rights underlying
such
Licensed Product in such country.
4.10 To
the
extent that the Company or any Affiliate of the Company is required (i) in
its
sole discretion after appropriate 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 use or sell Licensed Products or Licensed Processes under the Patent
Rights, the Earned Royalty payable under Section 4.1 shall be reduced by
[***]
the royalty payable to such third party; provided,
however,
in no
event shall the Earned Royalty be reduced to less than [***] percent ([***]%)
of
Net Sales.
4.11 Company
will pay Licensor a fee of [***] percent ([***]%) of all revenue received
from
granting of sublicenses to sublicensees, excluding amounts paid by sublicensee
to Company directly relating to (a) any issuance of debt or equity securities
of
the Company; (b) the research and development of the Technology or dedicated
to
establish a marketing and sales force for sales of the Technology; (c) Net
Sales
of Licensed Products; and/or (iv) 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 (the “Sublicense
Fee”).
For
instance, the Company would not owe the Licensor a Sublicense Fee based on
royalties it receives from a sublicensee for Net Sales of Licensed Products,
other than those described in Section 4.4.
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 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
open 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 Licensor’s internal audit division and/or by another designated
auditor selected by 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 [***] percent
([***]%) and [***] Dollars ($[***]) for any twelve- (12) month period the
Company shall reimburse 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. Notwithstanding the foregoing, all payments
required under this Article 5 shall be due within thirty- (30) days of the
date
Licensor provides the Company notice of the payment due.
5.2 Within
sixty- (60) days from the end of each quarter of each calendar year, the
Company
shall deliver to 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 for Licensed Products and Licensed Processes used, leased
or
sold, by or for the Company or its Affiliates;
7
5.2.3 Deductions
applicable in computed Net Sales, if any;
5.2.4 Total
Earned Royalties due based on Net Sales by or for the Company or its Affiliates
or any sublicensee;
5.2.5 Names
and
addresses of all sublicensees and Affiliates of the Company;
5.2.6 On
an
annual basis, the Company’s year-end financial statements.
5.3 With
each
such quarterly report submitted, the Company shall pay to Licensor the royalties
due and payable under this Agreement. If no royalties shall be due, the Company
shall indicate so in writing.
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 [***] percent
([***]%).
5.5 The
Company agrees to forward to 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 Licensor
may
reasonably request, as may be pertinent to an accounting of
royalties.
5.6 On
a
semi-annual basis, the Company shall provide Licensor with a report detailing
the clinical progress of Licensed Products that have been made since the
previous such report and steps that are being taken to further develop and
commercialize Licensed Products.
5.7 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, Licensor may disclose any such information required to be disclosed
pursuant to any judicial, administrative or governmental request, subpoena,
requirement or order, provided that 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 Effective Date, at the Company’s expense and providing Licensor has received
the Patent Fee, the Company shall diligently prosecute and maintain the Patent
Rights set forth in Exhibit
A
hereto
(as the same may be amended or supplemented from time to time after the date
hereof), including, but not limited to, the filing of patent applications
which
may be required. The Company agrees to keep Licensor reasonably well informed
with respect to the status and progress of any such applications, prosecutions
and maintenance activities and to consult in good faith with Licensor and
take
into account 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 Licensor at least sixty- (60) days notice and a reasonable
opportunity to take over prosecution of such patent or patent application.
In
such event, Licensor shall have the right, but not the obligation, to commence
or continue such prosecution and to maintain any such patent or patent
obligation under its own control and at its expense in which case the license
to
Company to such patent or patent application in such jurisdiction will
terminate. The Company agrees to cooperate in such activities including
execution of any assignments or other documents necessary to enable Licensor
to
obtain and retain sole ownership and control of such patents or patent
applications.
8
6.3 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 §271(e) 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 §505(j) of the Act or an NDA for a Licensed Product
pursuant to §505(b)(2) of the Act; and (c) 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 Licensee, 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
Licensor.
6.4 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 Article 6 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
Section 6.2 and/or Section 6.3 above.
ARTICLE
7 - TERMINATION
7.1 If
the
Company shall become bankrupt, or shall file a petition in bankruptcy, 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 Upon
any
material breach or default of this Agreement by the Company, other than as
set
forth in Section 7.1 above, Licensor shall have the right to terminate this
Agreement and the rights, privileges and license granted hereunder by giving
ninety- (90) days prior written notice to the Company. Subject to Article
8,
such termination shall become effective immediately upon notice from the
Company
following such ninety- (90) day period unless the Company shall have cured
any
such breach or default prior to the expiration of the ninety- (90) day period
referred to above. If a dispute regarding termination is addressed according
to
Article 8, 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
provided however, that Company fulfills all rights and obligations to Licensor
under this Agreement that are not in dispute.
7.3 The
Company shall have the right at any time to terminate this Agreement in whole
or
as to any portion of the Patent Rights, for any reason or no reason, by giving
thirty- (30) days notice thereof in writing to Licensor.
7.4 Upon
termination of this Agreement for any reason, 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, 10, 13, and
15.
The Company and/or any sublicensee thereof may, however, after the effective
date of such termination and continuing for a period not to exceed twelve-
(12)
months thereafter, sell all completed Licensed Products, and any Licensed
Products in the process of manufacture at the time of such termination, and
sell
the same, provided that the Company shall pay or cause to be paid to 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.
9
7.5 If
not
terminated sooner, this Agreement shall terminate, on a country by country
basis, on the date of the last to expire claim contained in the Patent Rights
(the “Term”),
at
which time the Company will have an irrevocable, paid up, royalty-free license
under the Patent Rights to make, have made, use, have used, sell and have
sold
Licensed Products.
ARTICLE
8 - DISPUTE RESOLUTION
8.1 The
Parties shall attempt in good faith to promptly resolve any dispute arising
out
of or relating to payments required under this Agreement between representatives
who have authority to settle the controversy within thirty- (30) days of
one
party notifying the second party of such dispute in writing.
8.2 If
the
matter pertaining to payments has not been resolved by negotiation within
thirty- (30) days, the parties shall attempt in good faith to settle the
dispute
by mediation under the then-current rules of the American Arbitration
Association (“AAA”).
The
neutral third party will be selected from the panel of neutrals of the AAA
in
accordance with the selection process of the AAA.
8.3 If
the
matter has not been resolved by mediation within ninety- (90) days of the
initiation of such procedure, or if either party does not participate in
mediation in good faith, the dispute shall be settled by arbitration before
a
tribunal of three arbitrators in a location mutually agreeable to both parties
in accordance with the rules of the AAA. Licensor shall select one- (1)
arbitrator, the Company shall select one- (1) arbitrator, and the third
arbitrator shall be selected by mutual agreement of the first two- (2)
arbitrators.
8.4 Any
claim, dispute, or controversy that does not concern payments, including
concerning the validity, enforceability, or infringement of any patent contained
in the Patent Rights licensed hereunder shall be resolved in any court having
jurisdiction thereof.
8.5 In
the
event that, in any arbitration proceeding, any issue shall arise concerning
the
validity, enforceability, or infringement of any patent contained in the
Patent
Rights licensed hereunder or any other issue not subject to arbitration,
the
arbitrators shall, to the extent possible, resolve all issues other than
such
issues including validity, enforceability, and infringement; 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 such
issues, unless an order staying the arbitration proceeding shall be entered
by a
court of competent jurisdiction. Neither Party shall raise any issue concerning
the validity, enforceability, and/or infringement of any patent contained
in the
Patent Rights licensed hereunder, in any proceeding to enforce any arbitration
award hereunder, or in any proceeding otherwise arising out of any such
arbitration award.
8.6 The
costs
of such arbitration shall be borne proportionate to the finding of fault
as
determined by the Arbitrator. Any court of competent jurisdiction may enter
judgment on the arbitration award.
10
ARTICLE
9 - INFRINGEMENT AND OTHER ACTIONS
9.1 The
Company and Licensor shall promptly provide written notice, to the other
party,
of any alleged infringement by a third party of the Patent Rights 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, Licensor hereby agrees that the Company may join
Licensor as a party in any such suit (and will join at the Company’s request),
provided that the Company pays all of Licensor’s reasonable out-of-pocket
expenses. The Company shall indemnify and hold Licensor harmless against
any
costs, expenses or liability that may be found or assessed against Licensor
in
any such suit other than resulting from Licensor’s negligence or willful
misconduct. Any recovery of damages pursuant to this Section 9.2 shall be
retained entirely by the Company and allocated pursuant to Section 9.4
below.
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 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 above. Otherwise, the Company shall have
the
right, but not the obligation, to defend any such claim or suit. In the event
the Company elects not to defend such suit, Licensor shall have the right,
but
not the obligation to do so at its sole expense.
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 Licensor
and
the Company in accordance with Section 4.1.1.
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 Licensor, at any time prior thereto,
of
its intention not to bring suit against the alleged infringer, then, and
in
those events only, Licensor shall have the right, but not the eobligation,
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 Licensor shall be borne by Licensor and 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, INDEMNITY
10.1 EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
FOR
A PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR PENDING.
11
10.2 Nothing
in this Agreement should be construed as:
10.2.1 A
warranty or representation by Licensor as to the validity or scope of any
Patent
Rights;
10.2.2 A
warranty or representation that anything made, used, sold or otherwise disposed
of under any license granted in this Agreement is or will be free from
infringement of patents of third parties; or
10.2.3 A
requirement that Licensor shall file any patent application, secure any patent,
or maintain any patent, including without limitation any Licensed Patents,
in
force.
10.3 The
Company agrees to defend, indemnify and hold Licensor harmless from and against
all liability, demands, damages, including without limitation, expenses or
losses including death, personal injury, illness or property damage 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 Licensor’s negligence or willful misconduct. 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 Licensor as provided in this Article. The Licensor
agrees
to defend, indemnify and hold Company harmless from and against all liability,
demands, damages, including without limitation, expenses or losses including
death, personal injury, illness or property damage arising directly or
indirectly out of a negligent or willful act of Licensor including pertaining
to
clinical evaluations of Licensed Compounds, Processes and Products.
ARTICLE
11 - 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, the Company may assign this Agreement without
the
consent of Licensor (i) to a purchaser, merging or consolidating corporation,
or
acquiror of substantially all of the Company’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)
to an
Affiliate of the Company.
ARTICLE
12 - PAYMENT OF FEES AND EXPENSES
Each
of
the Company and 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
13 - USE OF NAMES AND PUBLICATION
13.1 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 Licensor
or
any of its units (including contraction, abbreviation or simulation of any
of
the foregoing) without the prior, written consent of Licensor; provided,
however, that Licensor acknowledges and agrees that the Company may use the
names of 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.
12
13.2 Nothing
herein shall be deemed to establish a relationship of principal and agent
between Licensor and the Company, nor any of their agents or employees for
any
purpose whatsoever.
13.3 In
the
event that Licensor desires to publish or disclose, by written, oral or other
presentation, Patent Rights, Know-how, or any material information related
thereto then Licensor shall notify the Company in writing by facsimile where
confirmed by the receiving party, and/or by certified or registered mail
(return
receipt requested) of their intention at least sixty- (60) days prior to
any
speech, lecture or other oral presentation and at least ninety- (90) days
before
any written or other publication or disclosure. The Licensor shall include
with
such notice a description of any proposed oral presentation or, in any proposed
written or other disclosure, a current draft of such proposed disclosure
or
abstract. The Company may request that the Licensor, no later than thirty-
(30)
days following the receipt of such notice, delay such presentation, publication
or disclosure for up to an additional sixty- (60) days in order to enable
the
Company to file, or have filed on their behalf, a patent application, copyright
or other appropriate form of intellectual property protection related to
the
information to be disclosed or request that Licensor do so. Upon receipt
of such
request to delay such presentation, publication or disclosure, Licensor shall
arrange for a delay of such presentation, publication or disclosure until
such
time as the Company or Licensor have filed, or had filed on its behalf, such
patent application, copyright or other appropriate form of intellectual property
protection in form and in substance reasonably satisfactory to the Company
and
Licensor. If the Licensor does not receive any request from the Company to
delay
such presentation, publication or disclosure, Licensor may submit such material
for presentation, publication or other form of disclosure.
ARTICLE
14 - 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 Licensor:
Notices
or other Communications:
CCF
Innovations
0000
Xxxxxx Xxxxxx / Xxxxxxxx X00
Xxxxxxxxx,
Xxxx 00000
Attn:
Licensing Coordinator
Tel:
000-000-0000
Fax:
000-000-0000
E-mail:
xxxxx@xxx.xxx (Xx. Xxxxx Xxxx)
For
technical/scientific issues, with a copy to:
Taolin
Yi, Ph.D. / Mailcode NB40
13
For
legal
issues, with a copy to:
Office
of
General Counsel / Mailcode H18
For
use
of name and/or publicity issues, with a copy to:
Chief
Communications Officer / Mailcode H18
Payments:
The
Cleveland Clinic Foundation
Attention:
CCF Innovations (Agreement No. 02190-001)
P.O.
Lockbox 931532
Xxxxxxxxx,
XX 00000
Licensor’s
Federal Tax Identification Number: 00-0000000.
In
the
case of the Company:
Greenwich
Therapeutics, Inc.
000
Xxxxxxx Xxxxxx
00xx
Xxxxx
Xxx
Xxxx,
XX 00000
Attn:
President and CEO
Tel:
(000) 000 0000
Fax:
(000) 000 0000
ARTICLE
15 - CONFIDENTIALITY
Any
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 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 the 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:
(i) The
Company receives at any time from a third-party lawfully in possession of
same
and having the right to disclose same;
(ii) Is,
as of
the date of this Agreement, in the public domain, or subsequently enters
the
public domain through no fault of the Company;
(iii) Is
independently developed by the Company as demonstrated by written evidence
without reference to information disclosed to the Company by
Licensor;
14
(iv) Is
disclosed pursuant to the prior written approval of Licensor; or
(v) 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 Licensor and Licensor has agreed to such disclosure in writing
or
has exhausted its right to contest such disclosure.
ARTICLE
16 - INSURANCE
16.1 At
such
time as any product, process, service relating to, or developed pursuant
to,
this Agreement is being commercially distributed or sold (other than for
the
purpose of obtaining regulatory approvals) by Company or sublicensee, Company
shall at its sole cost and expense, procure and maintain comprehensive general
liability insurance in amounts not less than [***] Dollars ($[***]) per incident
and naming the Licensor as additional insureds. Such comprehensive general
liability insurance shall provide product liability coverage for Company’s
indemnification under this Agreement. If Company elects to self-insure all
or
part of the limits described above (including deductibles or retentions which
are in excess of [***] Dollars ($[***]) annual aggregate) such self-insurance
program must be acceptable to Licensor. Such insurance will be considered
primary as to any other valid and collectible insurance, but only as to acts
of
the named insured. The minimum amounts of insurance coverage required shall
not
be construed to create a limit of Company’s liability with respect to its
indemnification under this Agreement.
16.2 Company
shall provide Licensor with written evidence of such insurance upon request
of
the Licensor. Company shall provide the Licensor with written notice at least
sixty- (60) days prior to the cancellation or non-renewal of such insurance;
if
Company does not obtain replacement insurance providing commercially reasonable
coverage within such sixty- (60) day period, the Licensor shall have the
right
to terminate this Agreement effective at the end of such sixty- (60) day
period
without notice or any additional waiting periods.
16.3 Company
shall maintain such comprehensive general liability insurance beyond the
expiration or termination of this Agreement during (i) the period that any
product, process, or service, relating to, or developed pursuant to, this
Agreement is being commercially distributed or sold by Company or by a
sublicensee, and (ii) a commercially reasonable period thereafter.
ARTICLE
17 - MISCELLANEOUS PROVISIONS
17.1 This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of Ohio, without regard to its principles of
conflicts of laws.
17.2 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.
17.3 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 change of modification except by the execution of a
written instrument subscribed to by the parties hereto.
17.4 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.
15
17.5 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.
17.6 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.
17.7 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.
17.8 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.
17.9 Each
party hereto shall be excused from any breach of this Agreement that is
proximately caused by governmental regulation, act of war, strike, act of
God or
other similar circumstance normally deemed outside the control of the
parties.
ARTICLE
18 - REPRESENTATIONS AND WARRANTIES OF LICENSOR
As
of the
Effective Date of this Agreement, Licensor represents and warrants that to
its
knowledge and belief:
(i) Licensor
has all right, title, and interest in and to the Patent Rights and Know-how,
including the exclusive, absolute, and irrevocable right, title and interest
thereto, free and clear of all liens, charges, encumbrances or other
restrictions or limitations of any kind whatsoever;
(ii) Licensor
has not issued any licenses, options, restrictions, liens, rights of third
parties, disputes, royalty obligations, proceedings or claims limiting
Licensor’s rights or the rights of the Company under this Agreement or which may
reasonably lead to a claim of infringement or invalidity regarding, any part
or
all of the Patent Rights or Know How or their use;
(iii) 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, or other
intellectual property right of any third party and, to the knowledge of the
Licensor. There is no claim pending, filed or threatened against Licensor,
of
infringement, interference or invalidity regarding any part or all of the
Patent
Rights or Know-how or their use;
(iv) The
US
and foreign patent applications and patents itemized on Exhibit A set forth
all
of the patents and patent applications owned by or licensed by Licensor as
of
the Effective Date claiming the Technology in the Field of Use; and
(v) Licensor
has provided Company with copies of all documents reflecting support or funding
for all or part of the research leading to Patent Rights and Know How, and
has
listed all funding agencies on Exhibit
B.
16
IN
WITNESS WHEREOF,
the
parties hereto have executed this Agreement, in triplicate by proper persons
thereunto duly authorized.
THE
CLEVELAND CLINIC FOUNDATION (LICENSOR):
By: ______________________________ Date: __________,
2005
Name: Xxxxxxx
X. X’Xxxxx
Title: Chief
Financial Officer
GREENWICH
PHARMACEUITICALS, INC.
By: ______________________________ Date: __________,
2005
Name: ______________________________
Title: ______________________________
Acknowledged
(not signatories):
By: ______________________________ Date: __________,
2005
Name: Xxxxx
Xxxxxxxx, M.D., Ph.D.
Title: Chairman
and Director, Cleveland Clinic Taussig Cancer Center
By: ______________________________ Date: __________,
2005
Name: Xxxx
XxXxxxxxx, Ph.D.
Title: Chairman,
Xxxxxx Research Institute
By: ______________________________ Date: __________,
2005
Name: Taolin
Yi, Ph.D.
Title: Staff
Scientist
17
EXHIBIT
A
|
Serial
Number
|
Title
|
Pub.
Date
|
|
[***]
|
[***]
|
[***]
|
18
EXHIBIT
B
Funding
Sources:
The
following National Institute of Health grants to Taolin Yi, Ph.D. have funded
the development of the Technology:
1. R01
CA79891 (Principal Investigator: Taolin Yi, Ph.D.);
2. R01
GM58893 (Principal Investigator: Taolin Yi, Ph.D.);
3. R01
CA096636 (Principal Investigator: Taolin Yi, Ph.D.); and
4. R01
CA102481 (Principal Investigator: Taolin Yi, Ph.D.)
19
