Exhibit 10.13
Portions of this exhibit marked [*] are requested to be treated
confidentially.
LICENSE AGREEMENT
This License Agreement (this
“Agreement”) made as of this 28th day of August
, (the “ Effective Date”) 2007 by and between
TMRC Co., Ltd., a corporation
organized under the laws of Japan (“TMRC”), having a
place of business at 4-3, Akasaka 3-chome, Minato-ku, Tokyo,
Japan
and
INNOVIVE PHARMACEUTICALS, INC., a
corporation organized under the laws of the State of Delaware,
U.S.A. (“Innovive”), having a place of business at 555
Madison Avenue, New York, NY 10022, U.S.A.
WITNESSETH THAT:
WHEREAS, TMRC is engaged in research
and development of pharmaceutical product called TM-411
(Tamibarotene); and
WHEREAS, Innovive desires to obtain
an exclusive license under TMRC’s rights in the
pharmaceutical product called TM-411 (Tamibarotene) to research,
develop and commercialize such product in European countries;
and
WHEREAS, TMRC has agreed to grant
exclusive license under TMRC’s rights in the pharmaceutical
product called TM-411 (Tamibarotene) to research, develop and
commercialize such product in the Territory (as defined below)
.
NOW, THEREFORE, in consideration of
the foregoing premises and the mutual covenants herein contained,
the parties hereby agree as follows:
1.
DEFINITIONS
For purposes of this Agreement, the
terms defined in this Section 1 shall have the respective
meanings set forth below:
1.1 “ Affiliate ”
shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under
common control with such Person. A Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
1
1.2 “ Applicable Laws
” shall mean all applicable laws, statutes, rules,
regulations, ordinances, orders, decrees or administrative
decisions and the like of any nation or government.
1.3 “ Competent Authority
(ies) ” shall mean, collectively, the governmental
entities in each country in the Territory responsible for
(a) the regulation of any Product intended for use in the
Field (b) the establishment, maintenance and/or protection of
rights related to the Licensed Patent Rights, or (c) any other
applicable regulatory or administrative agency in any country in
the Territory that is comparable to, or a counterpart of, the
foregoing, including but not limited to European Agency for the
Evaluation of Medicinal products (EMEA) and each
country’s Medicines and Healthcare Products Regulatory Agency
(MHRA).
1.4 “ Compound ”
shall mean the compound known as TM-411 (Tamibarotene) listed on
Exhibit B, and any parts, analogs and derivatives
thereof.
1.5 “ Government
Approvals ” shall mean any approvals, licenses,
registrations, or equivalents of Competent Authorities that are
necessary for the manufacture, use, storage, transport, export,
import, clinical testing or sale of the Product.
1.6 “ Field 1 ”
shall mean the pharmaceutical prevention or treatment of acute
promyelocytic leukemia (APL), “Field 2” shall mean the
pharmaceutical prevention or treatment in human hematological
malignancies, including but not limited to Multiple myeloma (MM),
Myelodysplastic syndrome (MDS), Chronic myelomonocytic leukemia
(CMMoL), Chronic Myelocytic leukemia (CML) and Acute
myelocytic leukemia (AML) and solid tumor indications except
Hepatocelluar carcinoma (HCC). “ Field ” shall
collectively mean Field 1 and Field 2.
1.7 “ First Commercial
Sale ” shall mean that, with respect to any Product, the
first sale of such Product after all applicable marketing and
pricing approvals (if any) have been granted by the applicable
governing health authority of such country.
1.8 “ Joint Development
” shall mean work to be conducted by TMRC and/or Innovive
(including but not limited to work in which either TMRC or Innovive
participates by means of payment in part), such as nonclinical
and/or clinical studies of Product in the Field, in each case as
listed on Exhibit D.
1.9 “ LICENSE AGREEMENT
” shall mean the License Agreement that provides for a
license grant to TM-411 (Tamibarotene) for use in North America as
of December 6, 2006 between TMRC and Innovive.
1.10 “ Licensed IP
Rights ” shall mean, collectively, the Licensed Patent
Rights, Licensed Trademark Rights and the Licensed Know-How
Rights.
1.11 “ Licensed Know-How
Rights ” shall mean all trade secret and other know-how
rights in and to all data, information, compositions and other
technology, including the Compound (and including, but not limited
to, formulae, procedures, protocols, techniques and results of
experimentation and testing) which are available to TMRC and are
necessary or useful for Innovive to make, use, develop, sell or
seek regulatory approval to market a composition, or to practice
any method or process, at any time claimed or disclosed in any
issued patent or pending patent application within the Licensed
Patent Rights or which otherwise relates to the Compound.
1.12 “ Licensed Patent
Rights ” shall mean (a) the patents and patent
applications listed on Exhibit A hereto, (b) all patents
and patent applications in the Territory that claim or cover the
Compound and for which TMRC heretofore or hereafter has an
ownership or (sub) licensable interest, (c) all
divisions, continuations, continuations-in-part, that claim
priority to, or common priority with, the patent applications
listed in clauses (a) — (b) above or the patent
applications that resulted in the patents described in clauses (a)
— (b) above, and (d) all patents that have issued
or in the future issue from any of the foregoing patent
applications, including utility, model and design patents and
certificates of invention, together with any reissues,
reexaminations, renewals, extensions or additions thereto.
1.13 “ Licensed Trademark
Rights ” shall mean (a) trademark owned by TMRC all
common law rights and registered rights in and to the
Trademark.
1.14 “ MAA ” shall
mean a Marketing Authorization Application, or similar application
for marketing approval of a Product for use in the Field submitted
by Innovive to the applicable Competent Authority, or its foreign
equivalent.
1.15 “ Net Sales ”
shall mean, with respect to any Product, the gross sales price of
such Product invoiced by Innovive and its sublicensees or its
Affiliate to customers who are not Affiliates (or are Affiliates
but are the end users of such Product) less, to the extent actually
paid or accrued by Innovive and its sublicensees or its Affiliate
(as applicable), (a) credits, allowances, discounts and
rebates to, and chargebacks from the account of, such customers for
nonconforming, damaged, out-dated and returned Product;
(b) freight and insurance costs incurred by Innovive and its
sublicensees or its Affiliate (as applicable) in transporting such
Product to such customers; (c) cash, quantity and trade
discounts, rebates and other price reductions for such Product
given to such customers under price reduction programs;
(d) sales, use, value-added and other direct taxes incurred on
the sale of such Product to such customers; (e) customs
duties, tariffs, surcharges and other governmental charges incurred
in exporting or importing such Product to such customers;
(f) sales commissions incurred on the sale of such Product to
such customers; and (g) an allowance for uncollectible or bad
debts determined in accordance with generally accepted accounting
principles.
1.16 “ Person ”
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
1.17 “ Phase II Clinical
Trial ” shall mean a Phase II human clinical trial
sponsored by Innovive or its Affiliate that is intended to
initially evaluate the effectiveness of the Compound for a
particular indication or indications in patients with the disease
or indication under study, and is conducted in any country in
Territory.
1.18 “ Phase III Clinical
Trial ” shall mean Phase III human clinical trial
sponsored by Innovive or its Affiliate that is to investigate the
safety and efficacy use of the Compound which investigation will
include comparative trials with appropriate antitumor agents.
1.19 “ Product(s)
” shall mean any therapeutic or preventative pharmaceutical
products containing the Compound as an ingredient.
1.20 “ Registration(s)
” shall mean any and all permits, licenses, authorizations,
registrations or regulatory approvals (including MAAs) required
and/or granted by any Competent Authority as a prerequisite to the
development, manufacturing, packaging, marketing and selling of any
product.
1.21 “ Royalty Term
” shall mean, with respect to each Product in each country,
the term for which a Valid Claim remains in effect and would be
infringed but for the license granted by this Agreement, by the
use, offer for sale, sale or import of such Product in such
country.
1.22 “ SUPPLY AGREEMENT
” shall mean the Supply Agreement between the parties
regarding the supply of Tamibarotene dated March 12, 2007
between TMRC and Innovive.
1.23 “ Territory ”
shall mean countries listed on Exhibit C.
1.24 “ Third Party
” shall mean any Person other than TMRC, Innovive and their
respective Affiliates.
1.25 “ Trademark ”
shall mean “OSALEUKIN”.
1.26 “ Valid Claim
” shall mean a claim of an issued and unexpired patent
included within the Licensed Patent Rights, which has not been held
permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
2.
REPRESENTATIONS AND WARRANTIES
Each party hereby represents and
warrants to the other party as follows:
2.1 Corporate Existence . Such
party is a corporation duly organized, validly existing and in good
standing under the laws of the state in which it is
incorporated.
2.2 Authorization and Enforcement
of Obligations . Such party (a) has the corporate power
and authority and the legal right to enter into this Agreement and
to perform its obligations hereunder, and (b) has taken all
necessary corporate action on its part to authorize the execution
and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly executed and
delivered on behalf of such party, and constitutes a legal, valid,
binding obligation, enforceable against such party in accordance
with its terms.
2.3 No Consents . All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such party in connection with license of this Agreement have
been obtained.
2.4 No Conflict . The
execution and delivery of this Agreement and the performance of
such party’s obligations hereunder (a) do not conflict
with or violate any requirement of applicable laws or regulations,
and (b) do not conflict with, or constitute a default under,
any contractual obligation of it.
2.5 Licensed IP Rights . As to
TMRC only, TMRC (a) is the sole owner or exclusive licensee of
the Licensed IP Rights, and except as TMRC has expressly informed
Innovive in writing prior to the date of this Agreement, has not
granted to any Third Party any license or other interest in the
Licensed IP Rights in Territory, (b) is not aware of any Third
Party patent, patent application or other intellectual property
rights that would be infringed (i) by practicing any process
or method or by making, using or selling any composition which is
claimed or disclosed in the Licensed Patent Rights or which
constitutes Licensed Know-How Rights, or (ii) by making, using
or selling Products, and (c) is not aware of any infringement
or misappropriation by a Third Party of the Licensed IP
Rights.
2.6 TMRC’s REPRESENTATION
AND WARRANTIES . EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT
NOTHING IN THIS AGREEMENT IS OR SHALL BE CONSTRUED AS (i) A
WARRANTY OR REPRESENTATION BY TMRC AS TO THE VALIDITY OR SCOPE OF
ANY LICENSED PATENT RIGHTS (ii) 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 OR OTHER INTELLECTUAL PROPERTY OF THIRD
PARTIES; OR (iii) A REPRESENTATION OR WARRANTY BY TMRC OF THE
ACCURACY, SAFETY, OR USEFULNESS FOR ANY PURPOSE OF ANY TMRC
KNOW-HOW AT ANY TIME MADE AVAILABLE BY TMRC. TMRC SHALL HAVE NO
LIABILITY WHATSOEVER TO INNOVIVE OR ANY OTHER PERSON FOR OR ON
ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE,
SUSTAINED BY, OR ANY DAMAGE ASSERTED OR ASSERTED AGAINST, OR ANY
OTHER LIABILITY INCURRED BY OR IMPOSED ON INNOVIVE OR ANY OTHER
PERSON, ARISING OUT OF IN CONNECTION WITH OR RESULTING FROM
(A) THE PRODUCTION, USE , OR SALE OF ANY PRODUCT BY INNOVIVE,
OR THE PRACTICE OF THE LICENSED PATENT RIGHTS ;BY INNOVIVE; OR
(B) THE USE BY INNOVIVE OF ANY TMRC KNOW-HOW, AND INNOVIVE
SHALL HOLD TMRC, OR ITS OFFICERS, EMPLOYEES , OR AGENTS, HARMLESS
IN THE EVENT TMRC, OR ITS OFFICERS, EMPLOYEES, OR AGENTS, IS HELD
LIABLE THEREFOR, EXCEPT TO THE EXTENT RESULTING FROM THE NEGLIGENCE
OR WILLFUL MISCONDUCT OF TMRC OR ITS OFFICERS, EMPOYEES, OR
AGENTS.
3.
LICENSE GRANT
3.1 Licensed IP Rights . TMRC
hereby grants to Innovive an exclusive license (with the right to
grant sublicenses ) under the Licensed IP Rights to conduct
research and to develop, make, have made, use, offer for sale, sell
and import Products in the Territory for use in the Field.
3.2 Availability of the Licensed
IP Rights . TMRC shall provide Innovive with a copy of all
information available to TMRC (including information regarding the
Japanese filing for the product) relating to the Licensed IP
Rights, Products or Compound, including without limitation:
(a) regulatory submissions including all protocols, protocol
amendments and investigator brochures, (b) communications with
the Competent Authorities (including the minutes of any meetings as
well as all pharmacovigilance documents heretofore or hereafter
prepared), (c) trial master files, including case report
forms, (d) listings and tables of results from the clinical
trials, (e) treatment-related serious adverse event reports from
the clinical trials, (f) storage of and access
permission to any retained samples of materials used in clinical
trials, and (g) access to CROs involved in the clinical
trials. Innovive shall provide TMRC, at TMRC’s cost for
copying and delivery and to the extent Innovive is not legally or
contractually prohibited therefrom, with all data and reports
developed or made by Innovive under this Agreement and are specific
to the Licensed IP Rights. Innovive shall grant to TMRC a
nonexclusive license to use such data and reports outside the
Territory, subject to TMRC paying to Innovive such cost for copying
and delivery, and Innovive grants to TMRC’s other licensees
of the Compound, to the extent Innovive is not legally or
contractually prohibited therefrom, a nonexclusive license to use
such data and reports in the Field outside the Territory subject to
a royalty to be mutually agreed upon by the parties in good faith
prior to the granting of such license.
Notwithstanding foregoing TMRC has
ownership for the data and reports accrued from Joint Development
and is free to use such data and reports in and outside the
Territory without any restriction.
3.3 Technical Assistance . For
a period of [*] following the date of this Agreement, Innovive may
request that TMRC provides directly, or indirectly if reasonably
possible to TMRC, such technical assistance to Innovive regarding
APL as Innovive reasonably requests regarding the Licensed IP
Rights, Products or Compound, including without limitation making
all data relevant to regulatory filings available to Innovive and
providing to Innovive all or part of TMRC’s inventory of GMP
and non-GMP Compound as the parties mutually agree. In the event
TMRC has adequate personnel available, TMRC shall undertake such
technical assistance on Innovive’s behalf for the period
determined between TMRC and Innovive. Innovive shall pay to TMRC
its pre-approved, documented, reasonable expense incurred by TMRC
in regarding such technical assistance to Innovive including but
not limited to all salary, round trip fee and accommodation fee for
providing such technical assistance.
3.4 Registrations. TMRC
acknowledges and agrees that Innovive shall own all Registrations
for Products for use in the Field, in each country in the
Territory. TMRC hereby grants to Innovive a free-of-charge right to
reference and use and have access to all other Registrations and
all other regulatory documents that relate to the Licensed IP
Rights, Products or Compound, including CTAs (Clinical Trial
Authorization), MAAs, and DMFs, and any supplements, amendments or
updates to the foregoing (for the purposes of this Section, the
“Right of Reference”) which TMRC has right to do so.
Innovive shall have the right to (sub) license the Right of
Reference to its sublicensees and Affiliates on the condition that
Innovive shall impose the same secrecy obligations as those of
Innovive. TMRC shall promptly notify Innovive of any written or
oral notices received from, or inspections by any Competent
Authority relating to any such Registrations, and shall promptly
inform Innovive of any responses to such written notices or
inspections and the resolution of any issue raised by such
Competent Authority. During the time that TMRC is the holder of a
Registration, if any, Innovive shall be entitled to attend any
major meetings and participate in telephone calls with the
Competent Authorities, including without limitation any major
meeting preparation, meeting co-ordination and preparation of
minutes.
3.5 Product Supply . Subject
to the terms and conditions contained herein, Innovive shall
purchase all the requirements of the Product in the Territory from
TMRC at a price of [*] Japanese yen (Yen[*]) per 2mg Tamibarotene
tablet or [*] percent ([*]%) of the average reference prices of
Product in [*] countries ([*] and [*]), whichever is higher;
provided, however, that in the
[*]
Confidential treatment requested; certain information omitted and
filed separately with the SEC.
event of
any unanticipated condition or circumstances that would have a
material, adverse impact on either party’s economic return
derived from such price of Product, the parties agree promptly to
negotiate in good faith to arrive at a new price with a view to
sharing equitably such adverse economic impact. Innovive shall
provide TMRC with an annual non-binding forecast by calendar
quarter Innovive’s estimated requirements. If the Supply
Agreement terminates, or if purchase of the Product is not feasible
due to a problem in compliance with regulations in the Territory,
or due to TMRC’s inability or unwillingness to provide the
total amounts required by Innovive, then the parties shall discuss
in good faith how to solve such problem and explore the
alternatives including allowing Innovive to manufacture product on
its own. If after such good faith discussions it becomes clear that
TMRC is unable to provide such required amounts of Product due to
TMRC’s inability or unwillingness, then Innovive shall have
the right to manufacture the Product itself, or to purchase the
Product from Third Parties; provided, however, that TMRC, Innovive
and such Third Parties shall in good faith discuss terms and
conditions concerning such Third Parties’ manufacture.
3.6 Continue or Return . If
Innovive does not pay any milestone under Section 4.4(1),
4.4(2) or 4.4(3) after TMRC has provided written notice to Innovive
and at least [*] days to make such payment, TMRC may terminate this
Agreement forthwith. If Innovive does not pay any milestone under
Section 4.4(6) to TMRC with respect to the use of the
development of Compound for any of the indication in Field 2 after
[*] years from the date of execution of this Agreement, upon
written notice to Innovive regarding any such use from TMRC,
Innovive shall continue such development with payment of milestone
under Section 4.4(6) or the exclusive right for such
development in Field 2 shall be converted to a nonexclusive right
and TMRC can license such rights in Field 2 without any restriction
other than Innovive’s nonexclusive right.
4.
FINANCIAL CONSIDERATIONS
4.1 Royalty Rate . In
consideration for the licenses granted to Innovive herein, during
the Royalty Term for a Product, Innovive shall pay to TMRC
royalties, with respect to each Product, equal to [*] percent
([*]%) of Net Sales of such Product by Innovive its Affiliates and
its sublicensees for the first year and following First Commercial
Sale and in subsequent years either (a) such [*] percent
([*]%) of Net Sales of such Product by Innovive or (b) [*] Japanese
yen (Yen[*]), whichever is greater in subsequent years, until
expiration of the last-to-expire patent or [*] years from marketing
Product on each indication respectively, whichever is later. If
Product is supplied to Innovive by TMRC, Innovive may use the
Trademark free of charge. If Product is not supplied to Innovive by
TMRC, Innovive shall pay to TMRC a trademark royalty of [*] percent
([*]%) of Net Sales of Product that uses the Trademark for [*]
years from the date when Innovive ceases to be supplied Product by
TMRC; provided, however, that Innovive shall not pay such trademark
royalty after expiration of this Agreement under
Section 10.1.
4.2 Third Party Royalties. If
Innovive, its Affiliates or sublicensees is required to pay
royalties to any Third Party in order to exercise its rights
hereunder to make, have made, use, sell, offer to sale or import
any Product, then Innovive s
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