Portions of this exhibit marked [*]
are omitted and are requested to be treated
confidentially.
THIS LICENSE
AGREEMENT (this “Agreement”) dated as of
December 6, 2006 (the “Effective Date”) is entered
into between TMRC CO., LTD., a privately-held corporation organized
under the laws of Japan (“TMRC”), having a place of
business at 4-3 Akasaka, 3-chome, Minato-ku, Tokyo 107-0052, 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.
WHEREAS, TMRC owns
or has rights in the Technology (as defined below).
WHEREAS, Innovive
desires to obtain an exclusive license under TMRC’s rights in
the Technology on the terms and conditions set forth
below.
NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants
herein contained, the parties hereby agree as follows:
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.
1.2
“ 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, including the FDA, (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.
1.3
“ FDA ” shall mean the Food and Drug
Administration of the United States, or the successor
thereto.
1.4
“ Field 1 ” shall mean the pharmaceutical
prevention or treatment in humans of the following indications:
acute promyelocytic leukemia (APL), “ Field 2
” shall mean the pharmaceutical prevention or treatment in
humans of the following indications : multiple
myeloma (MM),
myelodysplatic syndrome (MDS), and all solid tumor indications and
“ Field ” shall collectively mean Field 1 and
Field 2.
1.5
“ First Commercial Sale ” shall mean, 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.
1.6
“ Joint Work ” shall mean work in which TMRC
participates by means of payment in part relating to animal studies
and human clinical trial of Product in Field 1 to be conducted by
Innovive, as listed on Exhibit C .
1.7
“ Licensed IP Rights ” shall mean, collectively,
the Licensed Patent Rights, Licensed Trademark Rights and the
Licensed Know-How Rights.
1.8
“ 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, but not
limited to, formulae, procedures, protocols, techniques and results
of experimentation and testing) that are not Licensed Patent Rights
and 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 Technology.
1.9
“ Licensed Patent Rights ” shall mean
(a) the patents and patent applications listed on
Exhibit A hereto, (b) all U.S. Canadian and Mexican
patents and patent applications that claim or cover the Technology
in 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.
1.10
“ Licensed Trademark Rights ” shall mean all
common law rights and registered rights in and to the
Trademark.
1.11
“ NDA ” shall mean a New Drug Application, or
similar application for marketing approval of a Product for use in
the Field submitted to the FDA, or its foreign
equivalent.
1.12
“ 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.
1.13
“ 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.
1.14
“ Phase II Clinical Trial ” shall mean a human
clinical trial in any country in the Territory that is sponsored by
Innovive or its Affiliate and that is intended to initially
evaluate the effectiveness of a Product for a particular indication
or indications in patients with the disease or indication under
study or would otherwise satisfy requirements of 21 CFR 312.21(b),
or its foreign equivalent.
1.15
“ Product(s) ” shall mean any therapeutic or
preventative pharmaceutical product made from or comprising
Technology for human use in the Field.
1.16
“ Registration(s) ” shall mean any and all
permits, licenses, authorizations, registrations or regulatory
approvals (including NDAs) required and/or granted by any Competent
Authority as a prerequisite to the development, manufacturing,
packaging, marketing and selling of any product.
1.17
“ 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.
1.18
“ Technology ” shall mean the compound known as
TM-411 (Tamibarotene) listed on Exhibit B and any parts,
analogs or derivatives thereof.
1.19
“ Territory ” shall mean North America (the
United States of America, Canada, and Mexico).
1.20
“ Third Party ” shall mean any Person other than
TMRC, Innovive and their respective Affiliates.
1.21
“ Trademark ” shall mean a trademark defined in
the letter agreement titled “Re: Trademark relating to TM411
dated December 5th, 2006.
1.22
“ Valid Claim ” shall mean a claim of an issued
and unexpired patent or Trademark included within the Licensed
Patent Rights and Licensed Trademark 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.
3.1
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 1, and Field 2 under
Section 3.6.
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
Technology, 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 and to the extent Innovive
is not legally or contractually prohibited therefrom, with all data
and reports developed 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 costs, and
Innovive grants to TMRC’s other licensees of the Technology,
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 joint ownership for the data and reports accrued
from Joint Work and TMRC 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 in Field 1as Innovive reasonably
requests regarding the Licensed IP Rights, Products or Technology,
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 Technology as the
parties mutually agree. In the
[*]
Confidential treatment requested; certain information omitted and
filed separately with the SEC.
event TMRC has
adequate personnel available, TMRC shall undertake such technical
assistance on Innovive’s behalf. Innovive shall pay to TMRC
its pre-approved, documented reasonable costs including but not
limited to all salary, round trip fee and accommodation fee of
providing such technical assistance. In addition, upon signing of
this agreement, TMRC will make available to Innovive an English
translation of the Japanese summary of approval.
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 full access to
all other Registrations and all other regulatory documents that
relate to the Licensed IP Rights, Products or Technology, including
INDs, BLAs, NDAs and DMFs (whether as an independent document or as
part of any NDA, and all chemistry, manufacturing and controls
information), 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. 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, 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 pharmaceutical Products in the Territory from TMRC at a price
of [*] Japanese Yen (¥[*]) per 2mg Tamibarotene tablet.
Innovive shall provide TMRC with an annual non-binding forecast by
calendar quarter Innovive’s estimated requirements. If
purchase of the pharmaceutical Products 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
toTMRC’s inability or unwillingness, then Innovive shall have
the right to manufacture the Product itself, or to purchase the
pharmaceutical Products 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. Within [*] months of the Effective Date, TMRC and
Innovive shall enter into a definitive agreement of Supply
Agreement separately, on the terms and conditions outlined in this
section 3.5 to cover manufacture and supply of Products to
Innovive.
3.6
First Refusal Right . With respect to the use of the
Technology for either multiple myeloma or a solid tumor indication
(including hepatic cancer), within [*] months following the date
that (a) TMRC has provided to Innovive completed Phase II data
from an applicable clinical trial sponsored by or for TMRC, or
(b) if TMRC did not sponsor such a clinical trial, upon
written notice to Innovive regarding any such use, Innovive shall
have the exclusive right and option to include all patent and other
intellectual property regarding such use within the scope of the
Licensed IP Rights in Field 2 and included within the license grant
to Innovive set forth in Section 3.1. Such right and option
may be exercised at any time within such [*] months by
[*]
Confidential treatment requested; certain information omitted and
filed separately with the SEC.
Innovive
sending to TMRC written notice of such exercise. Upon exercise of
such right and option, all patent and other intellectual property
regarding such use shall be included within the scope of the
Licensed IP Rights and included within the license grant to
Innovive set forth in Section 3.1, and Innovive shall owe any
applicable milestone payments for such indication as set forth in
Section 4.3. If the [*] months expires with respect to a use
and Innovive has not provided such written notice, Innovive shall
retain the right to negotiate in good faith for any other such
uses.
4.
FINANCIAL CONSIDERATIONS
4.1.1
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
(a) [*] percent ([*]%) of Net Sales of such Product by Innovive,
its Affiliates and its sublicensees up to [*] US Dollars ($[*] USD)
in any calendar year, (b) [*] percent ([*]%) of Net Sales of such
Product by Innovive , its Affiliates and its sublicensees in excess
of [*] US Dollars ($[*] USD) but less than [*] US Dollars ($[*]
USD) in any calendar year, and (c) [*] percent ([*]%) of Net Sales
of such Product by Innovive, its Affiliates and its sublicensees in
excess of [*] US Dollars ($[*] USD) in any calendar year. Innovive
shall use the Trademark on any Product; provided, however, that
Innovive may cease to use the Trademark if the registration of
Trademark is not obtained. During the Royalty Term for a Product,
Innovive shall pay to TMRC an additional royalty of [*] percent
([*] %) of Net Sales of such Product by Innovive and its
Affiliates.
4.1.2
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 shall have
the right to credit one hundred percent (100%) of such Third Party
royalty payments against the royalties owing to TMRC under
Section 4.1.1 above with respect to sales of such Product in
such country; provided , however , that Innovive
shall not reduce the amount of the royalties paid to TMRC under
Section 4.1.1 above by reason of this Section 4.1.2, with
respect to sales of such Product in such country, to less than [*]
percent ([*]%) of Net Sales of such Product in such
country.
4.2
Combination Products . If a Product consists of components
that are covered by a Valid Claim and components that are not
covered by a Valid Claim, then for purposes of the royalty payments
under Section 4.1 for Net Sales of such Products, such Net
Sales, prior to the royalty calculation set forth in
Section 4.1, first shall be multiplied by the fraction
A/(A+B), where A is the value of the component covered by the Valid
Claim as reasonably determined by Innovive, and B is the value of
the component that is not covered by the Valid Claim as reasonably
determined by Innovive, and such resulting amount shall be the
“Net Sales” for purposes of the royalty calculation in
Section 4.1 for such Product.
4.3
Milestones . Innovive shall pay to TMRC the following
milestone payments within thirty (30) days following the first
achievement of the applicable milestone:
(i)Upon
signing of this Agreement, Innovive shall pay TMRC ¥10,000,000
in cash
[*]
Confidential treatment requested; certain information omitted and
filed separately with the SEC.
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