***Text Omitted and Filed
Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and
240.24b-2
THIS LICENSE
AGREEMENT (this “ Agreement ”) dated as of
March 14, 2007 (the “ Effective Date ”) is
entered into by and between CELL-MATRIX, INC., a Nevada corporation
(“ Cell-Matrix ”), having a place of business at
2110 Rutherford Road, Carlsbad, California 92008, and TRACON
PHARMACEUTICALS, INC., a Delaware corporation (“
Tracon ”), having a place of business at 4510
Executive Drive, Suite 330, San Diego, California
92121.
WHEREAS,
Cell-Matrix owns or has rights in the Cell-Matrix Patent Rights and
the Technology (as each is defined below).
WHEREAS,
Cell-Matrix, formerly known as Bio-Management, Inc., obtained
certain exclusive license patent rights pursuant to that certain
License Agreement by and between Cell-Matrix and the University of
Southern California (“ USC ”) effective as of
September 14, 1999 (as amended from time to time, the “
USC Agreement ”).
WHEREAS,
Cell-Matrix obtained ownership to certain rights in and to modified
antibodies pursuant to that certain Amended and Restated
Collaboration Agreement by and between Cell-Matrix and Applied
Molecular Evolution (“ AME ”) dated as of
October 15, 2004 (as amended from time to time, the “
AME Agreement ”).
WHEREAS,
Cell-Matrix has obtained certain rights to negotiate and receive a
commercial license grant (with the right to grant sublicenses) to
certain production systems pursuant to that certain Research
Evaluation Agreement between Micromet AG (an Affiliate of
Cell-Matrix, Inc.) and [***] made on [***] (as amended from time to
time, the “ [***] Agreement ”).
WHEREAS, Tracon
desires to obtain an exclusive license to the foregoing rights 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
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
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
“ AME ” shall have the meaning set forth in the
Recitals to this Agreement.
1.3
“ AME Agreement ” shall have the meaning set
forth in the Recitals to this Agreement.
1.4
“ BLA ” shall mean a Biologics License
Application, Product License Application, New Drug Application, or
Abbreviated New Drug Application submitted to the FDA, a Marketing
Approval Application filed with the EMEA, and any corresponding
applications in countries or territories other than the foregoing
submitted to the relevant Competent Authority, in each case for
marketing approval of a Product.
1.5
“ Cell-Matrix In-Licenses ” shall mean the AME
Agreement, [***] Agreement, the [***] License Agreement, and USC
Agreement.
1.6
“ Cell-Matrix Patent Rights ” shall mean
(a) the patents and patent applications listed on
Exhibit A hereto, (b) all patents and patent
applications in any country of the world that claim or cover the
Technology or its use, in each case in which Cell-Matrix has an
ownership or (sub)licensable interest as of the Effective Date, but
excluding the USC Patent Rights and the [***] Patent Rights,
(c) all patents and patent applications in any country of the
world to the extent specifically disclosing or claiming D93 [***],
in each case in which Cell-Matrix has an ownership or
(sub)licensable interest during the term of this Agreement, but
excluding the USC Patent Rights and the [***] Patent Rights,
(d) all divisions, continuations, and continuations-in-part,
that claim priority to, or common priority with, the patent
applications listed in clauses (a) — (c) above or the
patent applications that resulted in the patents described in
clauses (a) — (c) above (but, in the case of
continuations-in-part, only to the extent that such
continuations-in-part disclose or claim D93 or, provided that
Tracon has exercised its option pursuant to Section 3.2,
[***]), and (e) 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, renewals, extensions or additions
thereto.
1.7
“ Clinical Plan ” shall have the meaning set
forth in Section 3.9.
1.8
“ Competent Authority(ies) ” shall mean,
collectively, (a) the governmental entities in each country or
supranational organization that is responsible for the regulation
of any Product intended for use in the Field (including the FDA,
the EMEA and the MHLW), or (b) any other applicable regulatory
or administrative agency in any country or supranational
organization that is comparable to, or a counterpart of, the
foregoing.
1.9
“ Confidentiality Agreement ” shall mean that
certain Confidentiality Agreement made and entered into by
Cell-Matrix and Paramount as of July 13, 2006.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-2-
1.10
“ D93 ” shall mean the humanized IgG1 antibody
directed against denatured collagen with the variable domain amino
sequence listed in Exhibit B , together with any
derivatives, fragment or modifications of such antibody.
1.11
“ D93 Product ” shall mean a Product comprising
D93.
1.12
“ Development Milestone ” shall have the meaning
set forth in Section 8.3.
1.13
“ EMEA ” shall mean the European Medicines
Agency, or the successor thereto.
1.14
“ FDA ” shall mean the Food and Drug
Administration of the United States, or the successor
thereto.
1.15
“ Field ” shall mean the prevention, treatment,
diagnosis, detection, monitoring, prognosis or predisposition
testing for any disease, state or condition in humans or other
animals.
1.16
“ 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 Competent Authority of such
country.
1.17
“ [***] ” shall mean the [***] directed [***]
with the [***] listed in Exhibit C , together with any
[***] of such [***].
1.18
“ [***] Product ” shall mean a Product
comprising [***].
1.19
“ Indication ” shall mean any condition or
discrete disease pattern in the Field for which a BLA, supplemental
BLA, or similar regulatory filing may be filed.
1.20
“ JSC ” shall have the meaning set forth in
Section 3.10.
1.21
“ Knowledge ” shall mean the [***] (including,
the [***] and [***]) of Cell-Matrix, Micromet, Inc. or any of their
respective Affiliates and employees of Cell-Matrix, Micromet, Inc.
or their respective Affiliates with [***] regarding the [***] and
[***] regarding the [***].
1.22
“ Licensed IP Rights ” shall mean, collectively,
the Licensed Patent Rights and the Licensed Know-How
Rights.
1.23
“ Licensed Know-How Rights ” shall mean all
trade secret and other know-how rights in which Cell-Matrix has an
ownership interest or has a transferable interest, 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) which are necessary or
useful for Tracon to make, use, develop, sell or seek regulatory
approval to market a
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-3-
Product, or to
practice any method or process relating to a Product, and that
(a) is at any time claimed or disclosed in any issued patent
or pending patent application within the Cell-Matrix Patent Rights,
or (b) exists as of the Effective Date or during the term of
this Agreement to the extent specifically applicable to D93 [***]
or is generated by Cell-Matrix or its Affiliates in the course of
performing activities under this Agreement.
1.24
“ Licensed Patent Rights ” shall mean
(a) the Cell-Matrix Patent Rights, (b) the USC Patent
Rights, and (c) if Cell-Matrix has obtained a commercial
license grant from [***] under the [***] Agreement pursuant to
Section 3.7, the [***] Patent Rights.
1.25
“ [***] ” shall have the meaning set forth in
the Recitals to this Agreement.
1.26
“ [***] Agreement ” shall have the meaning set
forth in the Recitals to this Agreement.
1.27
“ [***] Know-How Rights ” shall mean all
know-how for which Cell-Matrix obtains a sublicensable right under
the [***] License Agreement.
1.28
“ [***] License Agreement ” shall have the
meaning as defined in Section 3.7.
1.29
“ [***] Patent Rights ” shall mean all patents
and patent applications for which Cell-Matrix obtains a
sublicensable right under the [***] License Agreement.
1.30
“ MHLW ” shall mean the Ministry of Health,
Labour and Welfare of Japan, or the successor thereto.
1.31
“ Net Sales ” shall mean, with respect to any
Product, the gross sales price of such Product invoiced by Tracon,
or any of its Affiliates or sublicensees to customers who are not a
sublicensee (or are a sublicensee but are the end users of such
Product) less, to the extent actually paid or accrued by Tracon, or
any of its Affiliates or sublicensees (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 Tracon, or any of its Affiliates or sublicensees (as applicable)
in transporting such Product to such customers to the extent
separately invoiced; (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; and (g) an allowance
for uncollectible or bad debts taken with respect to such Product,
in each case as determined in accordance with generally accepted
accounting principles.
1.32
“ Onset ” shall mean the first dosing of the
first patient in the applicable clinical trial.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-4-
1.33
“ Paramount ” shall mean Paramount BioSciences
LLC, a New York limited liability company.
1.34
“ 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.
1.35
“ Phase I Clinical Trial ” shall mean a human
clinical trial that is intended to initially evaluate the safety
and/or pharmacological effect of a Product in subjects or that
would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its
non-U.S. equivalent.
1.36
“ Phase IIa Clinical Trial ” shall mean a human
clinical trial that is intended to evaluate the pharmacokinetics
and safety of a Product for a particular indication or indications
in human subjects with the disease or indication under study and
establish the dose of a Product or that would otherwise satisfy the
requirements of US 21 C.F.R. §312.21(b) or its non-U.S.
equivalent.
1.37
“ Phase IIb Clinical Trial ” shall mean a human
clinical trial that is intended to initially evaluate the efficacy
of a Product for a particular indication or indications in human
subjects with the disease or indication under study or that would
otherwise satisfy the requirements of US 21 C.F.R. §312.21(b)
or its non-U.S. equivalent.
1.38
“ Phase III Clinical Trial ” shall mean a human
clinical trial in any country the results of which could be used to
establish safety and efficacy of a Product as a basis for a BLA or
label expansion of a pharmaceutical product or that would otherwise
satisfy the requirements of 21 C.F.R. 312.21(c), or its non-US
equivalent.
1.39
“ Pivotal Trial ” shall mean a Phase IIb
Clinical Trial or Phase III Clinical Trial in any country the
results of which could be used to establish safety and efficacy of
a Product as a basis for a BLA or label expansion of a
pharmaceutical product.
1.40
“ Product(s) ” shall mean any product comprising
D93[***] [***].
1.41
“ Registration(s) ” shall mean any and all
permits, licenses, authorizations, registrations or regulatory
approvals (including BLAs) required and/or granted by any Competent
Authority as a prerequisite to the development, manufacturing,
packaging, marketing and selling of any product.
1.42
“ Royalty Term ” shall mean, with respect to
each Product in each country, the period commencing on First
Commercial Sale in such country and expiring on a
country-by-country basis on the later of (a) the expiration of
the last-to-expire Valid Claim that would be infringed but for the
license granted by this Agreement, by the manufacture, use, offer
for sale, sale or import of such Product in such country, or (b)
[***]years following the First Commercial Sale of such Product in
such country.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-5-
1.43
“ Sublicense Agreement ” shall mean any
agreement under which Tracon grants a sublicense under the license
set forth in Section 3.1.
1.44
“ Sublicensing Revenues ” shall mean, with
respect to any Product, the aggregate consideration received by
Tracon or any of its Affiliates in connection with an agreement
under which Tracon grants a sublicense under any of the rights
granted to Tracon under this Agreement to a Third Party (including
upfront fees, annual license fees and milestone payments), but
excluding amounts received by Tracon or any of its Affiliates
(i) as [***]under this Agreement or the under the Cell-Matrix
In-Licenses, (ii) to [***] or [***]after the execution of such
sublicense, [***], for such Product; (iii) [***] relating to such
Product; or (iv) in consideration for the [***]in a
transaction not made in connection with a Sublicense Agreement. In
the case of any [***]as shall be mutually agreed by the
parties.
1.45
“ Successful Completion ” shall mean that the
applicable Phase I Clinical Trial has shown a safe and tolerable
dose and that the Product had a side effect profile that does not
adversely affect the applicable Product’s eligibility to
enter the next phase clinical trial or, if applicable, to be
subject to a BLA.
1.46
“ Technology ” shall mean (a) D93 [***],
(b) any derivatives, fragment or modifications of any such
antibody, and (c) nucleotide sequences that encode any of the
foregoing.
1.47
“ Territory ” shall mean all countries of the
world.
1.48
“ Third Party ” shall mean any Person other than
Cell-Matrix or Tracon or any of their Affiliates.
1.49
“ USC ” shall have the meaning set forth in the
Recitals to this Agreement.
1.50
“ USC Agreement ” shall have the meaning set
forth in the Recitals to this Agreement.
1.51
“ USC Patent Rights ” shall mean the
“PATENT” and “PATENTS” as defined in the
USC Agreement.
1.52
“ Valid Claim ” shall mean (a) 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, and
(b) a claim included in a pending patent application included
in the Licensed Patent Rights that is being actively prosecuted and
that has not been canceled, withdrawn from consideration, finally
determined to be unallowable by the applicable governmental
authority (from which no appeal is or can be taken), or abandoned
or disclaimed, provided that notwithstanding the foregoing clause
(b), in the event that a pending claim in a pending patent
application does not issue in an issued
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-6-
patent within
[***]after the earliest date from which such patent application
claims priority, such a pending claim shall not be a Valid Claim,
unless and until such pending claim subsequently issues in an
issued patent, in which case such claim shall be reinstated and be
deemed to be a Valid Claim as of the date of issuance of such
patent in accordance with clause (a) above.
2.
REPRESENTATIONS AND WARRANTIES
2.1
Mutual Representations and Warranties . Each party hereby
represents and warrants to the other party, as of the Effective
Date, as follows:
2.1.1
Such party is a corporation duly organized, validly existing and in
good standing under the laws of the state in which it is
incorporated.
2.1.2
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 (except as limited by applicable bankruptcy, insolvency,
reorganization, moratorium or other laws of general application
affecting enforcement of creditors’ rights, or as limited by
general principles of equity that restrict the availability of
equitable remedies).
2.1.3
All necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such party in connection with this Agreement have been
obtained.
2.1.4
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.
2.2
Cell-Matrix Representations and Warranties . Cell-Matrix,
Micromet, Inc., and Micromet AG each hereby represent and warrant
to Tracon that, to its Knowledge as of the Effective
Date:
2.2.1
Cell-Matrix (a) is the sole owner or exclusive licensee of the
Licensed IP Rights, and except as Cell-Matrix has expressly
informed Tracon 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, (b) is not aware of any Third Party
patent, patent application or other intellectual property rights
that would be infringed by making, using or selling Products,
except as Cell-Matrix has informed Tracon in writing prior to the
date of this Agreement, and (c) is not aware of any
infringement or misappropriation by a Third Party of the Licensed
IP Rights.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-7-
2.2.2
Cell-Matrix has provided Tracon with complete and correct copies of
all Cell-Matrix In-Licenses, and there have been no modifications,
amendments or restatements other than as provided to Tracon prior
to the Effective Date. The Cell-Matrix In-Licenses are in full
force and effect in accordance with their terms. After giving
effect to this Agreement, there exist no breaches, defaults or
events which would (with the giving of notice, the passage of time
or both) give rise to a breach, default or other right to terminate
or modify any Cell-Matrix In-License. Cell-Matrix has not
transferred or granted, and Cell-Matrix shall not transfer or
grant, to any Third Party any license or other interest in the
Cell-Matrix In-Licenses that would conflict with the rights granted
to Tracon under this Agreement. With respect to the AME Agreement,
Cell-Matrix does not have any further obligation to AME with
respect to, and the negotiation and execution of this Agreement
shall not result in any right accruing to AME pursuant to
Section 7.5 of the AME Agreement. Other than [***] Cell-Matrix
has not filed any Registrations with any Competent Authority for
the Product.
2.3
Tracon Covenant . Tracon covenants and agrees that it shall
not knowingly, nor shall it knowingly cause or permit any Affiliate
or sublicensee to, use or practice the Licensed IP Rights outside
of the scope of the licenses granted in this Agreement, and not to
knowingly take any action or knowingly make any omission that would
cause Cell-Matrix to default under any of the Cell-Matrix
In-Licenses, or otherwise provide the other party under the
applicable Cell-Matrix In-License the right to terminate such
Cell-Matrix In-License.
2.4
Limitation on Representations or Warranties .
Notwithstanding anything to the contrary in this Agreement, a party
shall not be in breach of any representation or warranty made
pursuant to Section 2 to the extent such breach arises
directly from any fact or circumstance actually known by the other
party on or prior to the Effective Date.
2.5
Disclaimer of Warranties . EXCEPT FOR THE EXPRESS WARRANTIES
SET FORTH IN SECTION 2 AND SECTION 4.2.1, TRACON AND CELL-MATRIX
MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND TRACON AND CELL-MATRIX EACH SPECIFICALLY DISCLAIMS
ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL,
EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY
WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT
OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
3.1
Licensed IP Rights . Cell-Matrix hereby grants to Tracon an
exclusive license (with the right to grant sublicenses through
multiple tiers) under the Licensed IP Rights to conduct research
and to develop, make, have made, use, offer for sale, sell, import
and otherwise commercialize Products in the Territory for use in
the Field.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-8-
3.2
[***] to [***] . Cell-Matrix hereby grants to Tracon an
[***] to obtain an [***] (with the [***]) under the [***]. Tracon
may [***] at any time during the term of this Agreement. Upon
receipt of such notice by Cell-Matrix, [***], and the terms of this
Agreement shall apply to such [***] in all respects. Promptly
following the [***] and the [***], Cell-Matrix shall [***] for the
[***]then in Cell-Matrix’s possession.
3.3
Reservation of Rights . Except for the rights expressly
provided herein, nothing contained in this Agreement shall be
construed as granting or conveying (expressly, by implication, or
otherwise) to Tracon any license or other rights under any of
patent, know-how or other intellectual property rights of
Cell-Matrix or its Affiliates.
3.4
Sublicenses . Tracon shall, in each Sublicense Agreement,
require the sublicensee to transfer to Cell-Matrix if this
Agreement terminates and to Tracon if only such sublicense
terminates (a) documents and materials described in, and to
the extent associated with, Section 11.5 held, possessed or
transferable by such sublicensee; and (b) all patents and
know-how claiming inventions or discoveries relating to the
Products conceived or reduced to practice in the course of
developing or commercializing the Products pursuant to the
Sublicense Agreement owned or sublicensable by such sublicensee
(which shall be transferred either by assignment or by license with
rights to further sublicense). Any Sublicense Agreement shall be
consistent with the terms and conditions of this Agreement. Tracon
shall (i) provide Cell-Matrix with a copy of each Sublicense
Agreement; (ii) use commercially reasonable efforts to procure
the performance by any sublicensee of the terms of each such
Sublicense Agreement, and (iii) be responsible for any breach
of this Agreement that is caused (directly or indirectly) by the
performance (or failures to perform) of its sublicensee. The grant
of any such sublicense shall not relieve Tracon of its obligations
under this Agreement, except to the extent they are satisfactorily
performed by an Affiliate or sublicensee. In the event that Tracon,
after [***], then [***] shall be [***].
3.5
USC Agreement . Tracon agrees to be bound by the terms and
conditions of the USC Agreement applicable to
“SUBLICENSEES” (as defined in the USC Agreement). If,
prior the Effective Date, Cell-Matrix has not obtained written
permission from USC to grant the sublicense under the USC Patent
Rights as set forth in this Agreement, then promptly following the
Effective Date Cell-Matrix shall obtain such written consent from
USC. Cell-Matrix shall timely perform in full all obligations
required to be performed by Cell-Matrix under the USC Agreement.
Cell-Matrix promptly shall provide Tracon with copies of all
notices and other deliveries received under the USC Agreement.
Without the prior express written consent of Tracon, Cell-Matrix
shall not (and shall take no action or make no omission to) modify
or waive any provision of the USC Agreement that could impair the
value of the license and rights under the USC Patent Rights that
are granted to Tracon herein, or to terminate or have terminated
the USC Agreement. Within [***] following the Effective Date,
Cell-Matrix shall propose a written amendment to USC that amends
the USC Agreement such that if the USC Agreement [***], USC shall
[***] and thereafter Cell-Matrix shall use reasonable efforts to
negotiate and enter into such amendment with USC.
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-9-
3.6
AME Agreement . Cell-Matrix shall timely perform in full all
obligations required to be performed by Cell-Matrix under the AME
Agreement. Cell-Matrix promptly shall provide Tracon with copies of
all notices and other deliveries received under the AME Agreement.
Without the prior express written consent of Tracon, Cell-Matrix
shall not (and shall take no action or make no omission to) modify
or waive any provision of the AME Agreement that could impair the
value of the license and rights under the Cell-Matrix Patent Rights
that are granted to Tracon herein, or to terminate or have
terminated the AME Agreement.
3.7
[***] Agreement . Tracon acknowledges that as of the
Effective Date, Micromet AG’s rights under the [***]
Agreement are limited to a non-sublicensable research and
evaluation license grant. Within [***] following the Effective
Date, Micromet AG shall exercise its option to obtain a commercial
license under the [***] Agreement and shall cause Cell-Matrix to
use reasonable efforts to seek and obtain from [***] a definitive
license agreement (the “ [***] License Agreement
”) including a commercial license grant (with the right to
grant sublicenses) under and in accordance with the [***]
Agreement, and after obtaining such license grants, the [***]
Patent Rights and [***] Know-How Rights, as applicable, shall be
included within the scope of the Licensed IP Rights. Following the
execution of the [***] License Agreement, Cell-Matrix shall timely
perform in full all obligations required to be performed by
Cell-Matrix under the [***] License Agreement. Cell-Matrix promptly
shall provide Tracon with copies of all notices and other
deliveries received under the [***] License Agreement. Without the
prior express written consent of Tracon, Cell-Matrix shall not (and
shall take no action or make no omission to) modify or waive any
provision of the [***] License Agreement that could impair the
value of the license and rights under the [***] Patent Rights or
[***] Know-How Rights, as applicable, that are granted to Tracon
herein, or to terminate or have terminated the [***] License
Agreement.
3.8
Transfer of Know-How and Product Materials . Promptly
following the Effective Date, Cell-Matrix shall transfer to Tracon
all Licensed Know-How Rights that exist in written or electronic
form together with copies of all data, information, reports,
protocols, Registrations (including, without limitation, [***]),
and communications with Competent Authorities in each case with
respect to the D93 Product and in existence as of the Effective
Date, or in the case of the [***], on the effective date of [***].
Notwithstanding the foregoing, Cell-Matrix shall timely file the
required annual report to [***] for the current calendar year and
transfer such IND promptly after the filing of such annual report.
Cell-Matrix shall make its and its Affiliates’ employees and
consultants reasonably available to Tracon (at no cost to Tracon)
for consultation as reasonably necessary to provide an orderly
transfer of the foregoing information.
3.9
Clinical Plan . Following the Effective Date, Tracon shall
prepare and provide to Cell-Matrix a clinical development plan that
sets forth Tracon’s intended research, development,
manufacturing and clinical activities for the purpose of obtaining
marketing approval of the Products (the “ Clinical
Plan ”). From time to time during the term of this
Agreement, as Tracon makes any significant changes to its intended
development and clinical
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-10-
activities, but
not less than once per calendar year, Tracon shall provide to
Cell-Matrix an updated Clinical Plan.
3.10
Joint Steering Committee . The parties shall establish a
joint steering committee with at least one (1) representative
appointed by each party to review and discuss progress of
activities under the Clinical Plan (the “ JSC
”). The JSC shall meet on a semi-annual basis at times and
places to be mutually agreed upon in good faith. The purpose of the
JSC shall be solely to oversee such activities, and any decisions
of the JSC on matters regarding such activities shall not be
binding on the parties unless approved by all members of the JSC.
The JSC will not have any power to amend this Agreement and will
have only such powers as are specifically delegated to it under
this Agreement. If, with respect to a certain matter, there is not
unanimity by all members of the JSC, then the Chief Executive
Officers of each party shall meet and attempt to resolve the
matter. If after meeting and attempting to resolve any such matter
the Chief Executive Officers of the parties are unable to resolve
the matter, then the [***] shall have the final decision making
authority with respect to such matter. The JSC shall be disbanded
upon the date that is [***] from the Effective Date. In addition,
Cell-Matrix shall have the right to disband the JSC with respect to
a Product upon [***] written notice at any time after the [***] of
such Product [***].
3.11
Technical Assistance . For a reasonable period following
completion of the transfer pursuant to Section 3.8,
Cell-Matrix shall provide such technical assistance to Tracon as
Tracon reasonably requests regarding the Licensed IP Rights, D93
Products [***], or Technology. Tracon shall pay to Cell-Matrix its
documented reasonable out-of-pocket costs in providing such
technical assistance, and reimburse Cell-Matrix for time of
personnel of Cell-Matrix or its Affiliates engaged in the
performance of such technical assistance at a reasonable cost to be
agreed by the parties.
3.12
Registrations . Tracon shall file and shall own all
Registrations for Products for use in the Field in each country in
the Territory.
4.1
Delivery . Promptly following the Effective Date,
Cell-Matrix shall sell and deliver to Tracon the following
materials (collectively, the “ Materials
”):
(a)
[***] of clinical trial grade materials consisting of
D93;
(b) Master
cell banks for D93; and
(c) all
associated toxicology and reference material for D93 in
Cell-Matrix’s possession or control.
4.2
Delivery; Acceptance and Rejection .
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-11-
4.2.1
Cell-Matrix shall transfer ownership to the Materials to Tracon at
the facility of [***] (“ [***] ”) and the
parties shall execute such documents as necessary with [***] to
evidence such transfer of ownership, with delivery of the Materials
to be deemed made to Tracon upon such transfer. Cell-Matrix hereby
represents and warrants to Tracon that the Materials shall conform
to the applicable specifications set forth in Exhibit D
(the “ Specifications ”) at the time of such
delivery. Tracon shall be responsible for transferring the
Materials to its Third Party storage facility and for all risk of
the loss of the Materials, storing and handling the materials in
accordance all applicable requirements to maintain the quality
thereof, and all costs associated for storage of the Materials by
[***] or other Third Party, provided that the parties shall share
equally in the cost of shipping of and insurance for the Materials
from the [***] facility to such Third Party. Tracon shall inspect
the Materials upon transfer of ownership, and conduct such testing
as it deems appropriate to confirm that the Materials conform to
the Specifications. Any Materials not rejected in writing within
[***] after the date of transfer shall be deemed accepted, except
to the extent of any nonconformity with the Specifications not
discoverable through reasonable testing and in existence on the
date of delivery (a “ Latent Defect ”). If
Tracon determines that any Materials do not conform to the
Specifications, it shall promptly provide written notice thereof to
Cell-Matrix within the [***] acceptance period or within [***] of
any discovery of any Latent Defect. If Cell-Matrix does not agree
with Tracon’s determination, the Materials shall be submitted
for inspection and testing by a mutually agreed upon independent
laboratory, which shall make a final determination binding upon the
parties as to whether the Materials in question met the
Specifications as of the date of delivery. The cost of such testing
shall be borne by the party against which the independent
laboratory rules in its determination.
4.2.2
If Materials are determined to be not conforming to the
Specifications in accordance with the procedures set forth in
Section 4.2.1 above, Cell-Matrix shall in its discretion
replace the non-conforming Materials or reduce the applicable
payments due under Section 4.3 pro rata of the quantity of the
applicable Materials found to be not conforming. Such replacement
or reduction in payment shall be Tracon’s sole and exclusive
remedy in connection with any failure of Cell-Matrix to deliver
Materials that conform to Specifications or with regard to any
warranty made pursuant to Section 4.2.1.
4.3
Payment Schedule . Tracon shall pay to Cell-Matrix a total
of [***] ($[***]) in the aggregate for the Materials identified in
Section 4.1 above, consisting of (a) [***] ($[***]) for the
Materials described in Section 4.1(a), (b) [***] ($[***]) for
the Materials described in Section 4.1(b), and (c) [***]
($[***]) for the Materials described in Section 4.1(c). Tracon
shall pay the aggregate amount in accordance with the following
payment schedule:
(i)
[***] ($[***]) within [***] of the Effective Date of this
Agreement;
(ii)
[***] ($[***]) within [***] following the Effective
Date;
(iii)
[***] ($[***]) within [***] following the Effective
Date;
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-12-
(iv)
[***] ($[***]) within [***] following the Effective
Date;
(v)
[***] ($[***]) within [***] following the Effective
Date;
(vi)
[***] ($[***]) within [***] following the Effective
Date;
(vii)
[***] ($[***]) within [***] following the Effective Date;
and
(viii)
[***] ($[***]) within [***] following the Effective
Date.
5.
FINANCIAL CONSIDERATIONS
5.1
License Fees . In consideration of the licenses granted
hereunder, Tracon shall make the following non-refundable,
non-creditable one-time payments to Cell-Matrix as
follows:
(a) within
[***] following the Effective Date, Tracon shall pay to Cell-Matrix
[***] ($[***]), [***] ($[***]) of which is to be paid by
Cell-Matrix to AME pursuant to Section 4.1.5(d) of the AME
Agreement;
(b) on
the [***] anniversary of the Effective Date, Tracon shall pay to
Cell-Matrix [***] ($[***]); and
(c) within
[***] following the delivery of the [***] pursuant to
Section 3.2, Tracon shall pay to Cell-Matrix [***] ($[***])
which is to be paid by Cell-Matrix to AME pursuant to [***] the AME
Agreement.
5.2
Royalties . During the applicable Royalty Term for a
Product, subject to the terms and conditions of this Agreement,
Tracon shall pay to Cell-Matrix royalties, with respect to each
Product, equal to [***] percent ([***]%) of Net Sales of such
Product by Tracon, its Affiliates, or its sublicensees. Only one
royalty shall be owing for a Product regardless of how many Valid
Claims cover such Product. Tracon will be solely responsible for
any royalties or other payments due to any Third Party in order to
exercise rights hereunder to make, have made, use, sell, offer for
sale or import any Product (excluding any payments that may be due
under the Cell-Matrix In-Licenses, which are addressed in
Section 5.6 below).
5.3
Combination Products . If a Combination Product (as defined
below) is sold, then for the purpose of calculating royalties owed
under this Agreement on sales of the Combination Product, Net Sales
shall be calculated as follows: first, Tracon shall determine the
actual Net Sales of such Combination Product (calculated using the
above described deductions) and then such amount shall be
multiplied by the fraction A/(A+B), where A is the weighted (by
sales volume) average invoice price of the actual Product component
of such Combination Product, and B is the weighted (by sales
volume) average invoice price of the other active ingredient(s) of
such Combination Product or proprietary delivery device. If the
invoice price of either the applicable Product, the other active
ingredient(s) of such Combination Product or the
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-13-
or proprietary
delivery device cannot be determined, Net Sales of such Combination
Product shall be (i) equitably determined by the parties, and
(ii) if no agreement can be reached, submitted to binding
arbitration by a single arbitrator under the AAA arbitration rules
for Commercial Disputes. “ Combination Product ”
means [***] a product consisting of a Product and one or more other
active ingredients[***].
5.4
Sublicensing Revenues . During the applicable Royalty Term
for a Product, subject to the terms and conditions of this
Agreement, Tracon shall pay to Cell-Matrix a share of Sublicensing
Revenues as follows:
(a) With
respect to each agreement entered into by Tracon, its Affiliate or
sublicensee prior to [***] for a particular Product, Tracon shall
pay to Cell-Matrix [***] percent ([***]%) of the applicable
Sublicensing Revenues received by Tracon or any of its Affiliates
as a result of such agreement;
(b) With
respect to each agreement (other than those described in clause
(a) above) entered into by Tracon, its Affiliate or
sublicensee prior to [***] for a particular Product, Tracon shall
pay to Cell-Matrix [***] percent ([***]%) of the applicable
Sublicensing Revenues received by Tracon or any of its Affiliates
as a result of such agreement;
(c) With
respect to each agreement (other than those described in clauses
(a) or (b) above) that Tracon, its Affiliate or
sublicensee enters into prior to [***] for a particular Product,
Tracon shall pay to Cell-Matrix [***] percent ([***]%) of the
applicable Sublicensing Revenues received by Tracon or any of its
Affiliates as a result of such agreement; and
(d) With
respect to each agreement that Tracon enters into after [***] for a
particular Product, Tracon shall pay to Cell-Matrix [***] percent
([***]%) of the applicable Sublicensing Revenues received by Tracon
or any of its Affiliates as a result of such agreement.
5.5.1
Milestones due for any Product . Tracon shall pay to
Cell-Matrix the following non-refundable, non-creditable one-time
milestone payments within [***] following the first achievement of
the applicable milestone event:
|
|
$[***]
|
|
Successful Completion of the first
Phase I Clinical Trial for a Product conducted by or for Tracon,
its Affiliate or sublicensee;
|
|
|
|
|
|
|
|
$[***]
|
|
Onset of the first Phase IIa
Clinical Trial for a Product conducted by or for Tracon, its
Affiliate or sublicensee;
|
|
|
|
|
|
|
|
$[***]
|
|
Onset of the first Pivotal Trial for
a Product conducted by or for Tracon, its Affiliate or
sublicensee;
|
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with
respect to the omitted portions.
|
-14-
For the
avoidance of doubt, each milestone shall be paid once irrespective
of the number of times such milestone is achieved by one or more
Products and the total aggregate milestones payable under
Section 5.5.1 in the aggregate for all Products shall not
exceed $[***].
If a milestone
event described in Section 5.5.1 is achieved that is
subsequent to a preceding milestone event with respect to which
Tracon has not yet made the corresponding milestone payment, the
preceding milestone event is deemed achieved, and the corresponding
milestone payment is due and payable together with the payment of
the milestone payment for the subsequent milestone
event.
5.5.2
BLA Acceptance and Approval Milestones due for D93 [***] .
Tracon shall pay to Cell-Matrix the following non-refundable,
non-creditable one-time milestone payments within [***] following
[***] the first achievement of the applicable milestone event with
a D93 Product, [***]:
|
|
$[***]
|
|
upon acceptance for review by the
FDA of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the first Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
|
|
$[***]
|
|
upon acceptance for review by the
EMEA of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the first Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
|
|
$[***]
|
|
upon acceptance for review by the
MHLW of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the first Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
|
|
$[***]
|
|
upon acceptance for review by the
FDA of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the second Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
|
|
$[***]
|
|
upon acceptance for review by the
EMEA of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the second Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
|
|
$[***]
|
|
upon acceptance for review by the
MHLW of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the second Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
|
|
$[***]
|
|
upon acceptance for review by the
FDA of the first BLA submitted by Tracon, its Affiliate or
sublicensee for the third Indication for [***] the D93 Product
[***];
|
|
|
|
|
|
***
|
|
Certain
information on this page has been omitted and filed separately with
the Commission. Confidential
|
|