Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed; and is indicated with brackets where the information has been omitted from the filed...
Certain
identified information has been excluded from this exhibit because
it is both (i) not material and (ii) would be competitively harmful
if publicly disclosed; and is indicated with brackets where the
information has been omitted from the filed version of this
exhibit.
by and between
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
and
and
MABVAX THERAPEUTICS, INC.
BII Contract No: [***]
-1-
Table of Contents
Clause
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Page
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1.
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DEFINITIONS
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3
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2.
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SALE AND PURCHASE OF THE ACQUIRED ASSETS
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13
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3.
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LICENSE GRANT
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14
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4.
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[***] RIGHTS
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15
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5.
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PAYMENT
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15
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6.
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CLOSING
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19
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7.
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REPRESENTATIONS AND WARRANTIES
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20
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8.
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COVENANTS
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24
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9.
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TREATMENT OF CONFIDENTIAL INFORMATION
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28
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10.
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CONDITIONS TO MABVAX’S OBLIGATION TO CLOSE
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30
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11.
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CONDITIONS TO BII’S OBLIGATION TO CLOSE
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30
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12.
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INDEMNITY AND LIMITATIONS OF LIABILITY
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31
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13.
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DISPUTE RESOLUTION
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33
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14.
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TERM, EXPIRATION, AND TERMINATION
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34
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15.
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MISCELLANEOUS
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38
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-2-
This Asset Purchase and License Agreement (the
“Agreement”) is made on July 4, 2018 (the
“Effective
Date”) under the terms
and conditions herein by and between Boehringer Ingelheim
International GmbH having a
principal place of business at ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, (hereinafter referred to as
“BII”), MabVax Therapeutics Holdings,
Inc., a corporation organized
and existing under the laws of Delaware, USA, having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, and MabVax Therapeutics
Inc., a corporation organized
and existing under the laws of Delaware, USA, having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (MabVax Therapeutics Holdings, Inc., and
MabVax Therapeutics Inc. hereinafter referred to as
“MABVAX”).
RECITALS
WHEREAS, MABVAX owns or controls certain assets relating
to the [***] Program as further
defined herein; and
WHEREAS, BII is a pharmaceutical company engaged
in the research, development and commercialization of products
useful in the treatment of human and animal diseases and
conditions; and
WHEREAS, MABVAX wishes to sell to BII and BII wishes to
purchase from MABVAX the Acquired Assets as defined
herein.
NOW,
THEREFORE, the Parties agree as
follows:
1.
DEFINITIONS
1.1
Except as expressly
set forth herein, capitalized terms used in this Agreement, whether
used in the singular or plural, shall have the meanings set forth
below:
1.1.1
“Accounting Standards”
shall mean the maintenance of records and books of accounts in
accordance with International Financial Reporting Standards (IFRS)
or Generally Accepted Accounting Principles (GAAP) or those
accounting standards used in accordance with the German
Handelsgesetzbuch (HGB), which standards or principles (as
applicable) are currently used at the relevant time, and
consistently applied by the applicable Party.
1.1.2
“Acquired Assets” shall
mean all of MABVAX’s right, title and interest in and to all
of the assets owned or controlled by MABVAX relating solely and
exclusively to the [***] Program, consisting of (a) all [***]
Program Patents, (b) all [***] Program Know-How, (c) all [***]
Program Inventory, and (d) all Books and Records and Patent
Files.
1.1.3
“Action” shall mean any dispute, controversy,
claim, action, litigation, suit, cause of action, arbitration,
mediation, oppositions,
interferences or any proceeding
by or before any mediator,
arbitration panel or
Governmental Entity, or any investigation, subpoena, or demand
preliminary to any of the forgoing.
1.1.4
“Affiliate” means any corporation, firm,
limited liability company, partnership, or other entity that
directly or indirectly controls, or is controlled by, or is under
common control with a Party. For the purpose of this definition
only, “control” means ownership, directly or through
one or more Affiliates, of fifty percent (50%) (or such lesser
percentage which is the maximum allowed to be owned by a foreign
entity in a particular jurisdiction) or more of the shares of stock
entitled to vote
-3-
for the election of
directors in the case of a corporation, or fifty percent (50%) (or
such lesser percentage which is the maximum allowed to be owned by
a foreign entity in a particular jurisdiction) or more of the
equity interests in the case of any other type of legal entity, or
status as a general partner in any partnership, or any other
arrangement whereby a Party controls or has the right to control
the board of directors or equivalent governing body of a
corporation or other entity.
1.1.5
“Applicable Law” means all
applicable statutes, ordinances, regulations, rules, orders or
guidance of any Regulatory Authority or other Governmental Entity
or court of competent jurisdiction that may be in effect from time
to time.
1.1.6
“Assignment and
Assumption Agreement”
shall mean the general assignment and assumption agreement to be
executed by the Parties at
Closing, substantially in the form attached as Exhibit
A.
1.1.7
“Assumed Liabilities”
shall have the meaning as defined in Section 2.2.
1.1.8
“Authorization” shall mean any legally required consent,
authorization, approval, order, license, certificate or permit of
or from, or declaration or filing with, any Governmental Entity,
including without limitation, any legally required filing with any
Governmental Entity and the subsequent expiration of any legally
required waiting period under any antitrust
laws.
1.1.9
“▇▇▇▇ of
Sale” means the ▇▇▇▇ of
sale to be executed by the
Parties at Closing, substantially in the form of
Exhibit B.
1.1.10
“BII
Product” shall mean any
pharmaceutical product developed by or on behalf of BII using the
Acquired Assets.
1.1.11
“Books and Records” shall
mean all of MABVAX’s right, title, and interest in all books,
records and other documents used for and solely and exclusively related
to the [***] Program, including, but
not limited to, (a) records, experiments, etc. relating to
the discovery, affinity maturation and humanization of the
parent antibody to the leads particularly relating to [***], (b)
the preparation of [***], (c) purified [***], (d) research and development files [***] at
the Closing Date. For clarity, Books and Records shall include
original lab notebooks covering the [***] Program.
1.1.12
“Business Day” shall mean
any day other than a Saturday, a Sunday, or a day on which
commercial banks in Frankfurt am Main, Germany, or California, USA
are authorized or required by law to remain closed.
1.1.13
“Calendar Quarter”
means a period of three calendar months ending on March 31, June
30, September 30 or December 31 in any Calendar
Year.
1.1.14
“Calendar Year”
means each successive period of twelve (12) months commencing on
January 1 and ending on December 31.
1.1.15
“Claim” shall mean any Action asserted by MABVAX
against BII, or by BII against MABVAX.
1.1.16
“Clinical Trial”
means any experiment in which a drug or therapy is administered or
dispensed to, or used involving, one or more human subjects
(including but not limited to a Phase I Clinical Trial, and a
Phase III Clinical Trial).
-4-
1.1.17
“Closing” shall mean the closing of the transactions
contemplated by this Agreement in accordance with the terms and
upon the conditions set forth in this Agreement. The date upon
which Closing occurs shall be July 5, 2018 (the
“Closing
Date”).
1.1.18
“Combination Product”
means a pharmaceutical formulation containing as its active
ingredients [***]
1.1.19
“Commercially Reasonable
Efforts” shall mean
efforts and resources commonly used for a pharmaceutical product
which is at a similar stage in its research, development or
commercialization as the relevant BII Product [***] The level of
diligence stipulated in the immediately preceding sentence shall in
no event generate a higher level of diligence than BII would devote
to another pharmaceutical product owned by BII that is at a similar
stage in its research, development, commercialization and which is
of similar market potential as a BII Product at a similar stage of
its product life. Commercially Reasonable Efforts shall be
determined on a country-by-country basis for a particular BII
Product, [***]
1.1.20
“Confidential Information”
shall mean information and material, which is disclosed or provided
in oral, electronic, written or other tangible or intangible form
by a Party to another Party hereunder who receives it including but
not limited to [***] Program Patents and [***] Program Know-How.
Confidential Information shall not include information or material
that: (a) is already in the lawful possession of the receiving
Party at the time of disclosure by the disclosing Party, as
established by relevant documentary evidence; (b) is already in the
public domain as of the Effective Date or subsequently enters the
public domain through no faulting act or omission of the receiving
Party; (c) is lawfully received by the receiving Party on an
unrestricted basis from a Third Party having a lawful right to
disclose such information or material and is free of any obligation
of confidentiality to the disclosing Party; or (d) is similar in
nature to the purported confidential information or material but
which the receiving Party can demonstrate has been independently
created or invented, as established by relevant documentary
evidence.
1.1.21
“Co-Packaged Product”
means a single packaged product containing a [***] and one or more
other [***] components in a co-packaged form.
1.1.22
“Effective Date”
shall mean the date first written above.
1.1.23
“Encumbrance”
means any security interest, pledge, attachment, easement,
restriction, hypothecation, mortgage, lien (statutory or
otherwise), option, [***] (including any agreement to grant any of
the foregoing), or encumbrance.
1.1.24
“Excluded
Assets” shall mean MABVAX’s right title and interest to (a) all
cash and cash equivalents, (b) all trademarks, trade names and
logos, (c) all accounts and notes receivable, and all
claims, causes of action, defenses and rights of offset or
counterclaim (at any time or in any manner arising or existing,
whether ▇▇▇▇▇▇ or inchoate, known or unknown, contingent or
non-contingent) not included in the Acquired Assets.
1.1.25
“Excluded Liabilities”
shall have the meaning set forth in Section 2.2.
1.1.27
“Field” shall mean any and all uses; including
diagnosis, treatment, palliation or prevention of a disease or
medical [***] condition [***].
-5-
1.1.28
“First Commercial Sale”
means, in any country within the Territory, the first sale by BII,
its Affiliates or Sublicensees in an arm’s length transaction
of the
first BII Product to a Third Party other than a Sublicensee
in such country in exchange for cash (or some equivalent to which
value can be assigned) after Regulatory Approval for such BII
Product has been granted in such country.
1.1.29
“Generic Competition”
means and shall be deemed to exist in a particular country in the
Territory with respect to a particular [***]in a given Calendar
Quarter if in such country during such Calendar Quarter one or more
Generic Products (other than a Generic Product sold by BII or its
Affiliates or by a Sublicensee under a license granted by BII or
its Affiliates) [***] and (b) the aggregate unit sales of such
Generic Product in such country, as measured by IQVIA (formerly IMS
Health) standard units sold based on data provided by IQVIA
(formerly IMS Health) or, if such data is not available, such other
reliable data source as reasonably agreed upon by MABVAX and BII.
If no data is commercially available, then the Parties shall agree
upon a methodology for estimating the percentage unit-based market
share of Generic Products in such country.
1.1.30
“Generic Product” means,
with respect to a particular [***] and a particular country, (a)
any pharmaceutical product (other than the [***], as applicable)
that contains the same active ingredient(s) in a comparable quality
and quantity as such [***], as applicable irrespective of its
pharmaceutical form and is approved under an Abbreviated New Drug
Application (ANDA) or under 505(b)(2) of the United States Federal
Food, Drug and Cosmetic Act or any similar abbreviated route of
approval in such country, or (b) any biologic medicinal product
(other than the [***], as applicable) that is a biosimilar of such
[***], and, if the [***] is a component of a Combination Product, a
biosimilar of the Combination Product, and is approved under a
biological product licensure application submitted by any person
under 42 U.S.C. § 262(k) or any similar abbreviated route of
approval in such country.
1.1.31
“Governmental Entity”
shall mean any arbitrator, court, judicial, legislative,
administrative, or regulatory agency, commission, department,
board, or bureau or body or other government authority or
instrumentality or any person or entity exercising executive,
legislative, judicial, regulatory, or administrative functions of
or pertaining to government, whether foreign or domestic, whether
federal, state, provincial, municipal, or
other.
1.1.32
“Improvement”
shall mean any modifications, enhancements or improvements to a
compound, product,
technology or Intellectual
Property.
1.1.33
“Initiation” means, with
respect to a Clinical Trial, the first dosing of the first human
subject in such Clinical Trial.
1.1.34
“Intellectual Property”
shall mean all rights in Inventions, Patents, priority
rights, copyrights, design rights, trade names, trademarks, service
marks, trade secrets, Know-How, database rights, domain names and
all other intellectual property rights (whether registered or
unregistered) and all applications and rights to apply for any of
them, anywhere in the world.
1.1.35
“Invention” shall mean any
process, method, utility, formulation, composition of matter,
article of manufacture, discovery or finding or improvement that is
conceived and/or reduced to practice, whether patentable or
not.
1.1.36
“Inventor” shall mean inventorship as determined by
applicable (e.g., United States, European, or German) patent
statutes, regulations, and supporting case law.
1.1.37
“Invoice” means an
original invoice sent by MabVax
Therapeutics Holdings, Inc. to BII with respect to any
payment due hereunder, containing the information and meeting the
requirements as
-6-
1.1.38
“Know-How”
shall mean all technical information,
know-how and data, in any tangible or intangible form and whether
or not patentable, [***]
1.1.39
“Knowledge”
means knowledge, information, belief or awareness, after reasonable
investigation or diligence, of any MABVAX individuals, officers,
directors and employees who participate in the management or
operation of the [***] Program, including without limitation [***]
as of the Closing Date.
1.1.40
“Major Market” means each of the USA, Germany, the
United Kingdom, France, Italy, Spain and Japan.
1.1.41
“Material Adverse Effect”
means any event, occurrence, fact, condition or change that would
reasonably be expected to be materially adverse to or have a
material adverse effect on (a) the ability of MABVAX to carry out
its obligations under, and to consummate the transactions
contemplated by, this Agreement, or (b) the Assumed Liabilities or
the Acquired Assets, (c) BII’s ability to further exploit the
Acquired Assets, including without limitation the research, development, commercialization or
other exploitation of the Acquired Assets. For purposes of
clarity, none of the following events, changes or effects,
individually or in the aggregate, shall be considered a Material
Adverse Effect: (i) the effect of any change that generally affects
any industry in which BII or MABVAX operates; (ii) the effect of
any changes after the Effective Date in Applicable Law or
accounting rules not uniquely relating to BII or MABVAX; (iii) any
event, change or effect on the business, assets, or operations of
BII’s or MABVAX’s business primarily caused by, related
to or resulting from the announcement of the transactions
contemplated by this Agreement; (iv) the effect of any change in
the United States or foreign economies or securities or financial
markets; (v) the effect of any action taken by BII or BII’s
Affiliate with respect to the transactions contemplated by this
Agreement, other than actions taken pursuant to the provisions of
this Agreement; (vi) the effect of any Regulatory Approval of a
product that could compete with the BII Products; and (vii) the
indirect or consequential effect of any outbreak of hostilities,
acts of war, sabotage or terrorism or military actions or any
escalation or material worsening of any such hostilities, acts of
war, sabotage or terrorism or military actions existing as of the
date hereof.
1.1.42
“[***] Rights” shall have
the meaning as defined in Section 4.1.
1.1.43
“Net Sales” means, with respect to
a certain time period, the gross invoiced sales charged for BII
Product(s) sold by or for BII, its Affiliates and/or Sublicensees
in arm’s length transactions to Third Parties (but not
including sales relating to transactions between BII, its
Affiliates, and/or their respective Sublicensees) during such time
period, less the total of the following charges or expenses as
determined in accordance with the relevant Accounting Standards,
consistently applied across all products sold by BII, in each case
without duplication:
(a)
Sales returns and
allowances [***];
(b)
Credits or
allowances [***];
(c)
Rebates, chargeback
rebates, compulsory rebates, reimbursements or similar payments
[***];
(d)
Retroactive price
reductions applicable to sales of such BII Product;
-7-
(e)
Adjustments
actually made in accordance with consumer discount programs
[***];
(f)
The actual
acquisition cost of devices used for dispensing or administering
the Product that are shipped with the BII Product
[***];
(g)
Non-collectable
receivables related to BII Product;
(h)
Customs or excise
duties, sales tax, consumption tax, value added tax, and other
taxes (except income taxes);
(i)
Charges for
packing, freight, shipping and insurance (to the extent that BII,
its Affiliates and Sublicensees bear the cost for BII
Products)
BII,
its Affiliates and Sublicensees shall not incur discounts,
allowances, credits, rebates or other deductions on the BII Product
in order to advantage other products of BII, its Affiliates and
Sublicensees, such that the BII Product would bear a
disproportionate portion of such deductions. All defined deductions
in this section shall be consistent with BII’s audited
financial statements.
For the
sake of clarity and avoidance of doubt, sales by BII, its
Affiliates, or Sublicensees of a BII Product to Recognized Agent of
such BII Product in a given country shall be considered a sale to a
Third Party customer.
Any
disposal of BII Products for promotional or advertising purposes,
or use of BII Products in clinical or preclinical trials, given as
free samples, or distributed at no charge to patients unable to
purchase BII Product shall not be included in Net Sales. Donations
for charity reasons shall also not be part of Net
Sales.
Upon
any sale or other disposal of any BII Product that should be
included in Net Sales for any consideration other than an
exclusively monetary consideration on bona fide arm’s length
terms, then for purposes of calculating the Net Sales under this
Agreement, such BII Product shall be deemed to be sold exclusively
for money at the average sales price during the applicable
reporting period generally achieved for such BII Product in the
country in which such sale or other disposal occurred when such BII
Product is sold alone and not with other products.
In the
event no sales
price is available for the BII Product alone in such country during
the applicable reporting period, then such BII Product shall be
deemed to be sold exclusively for money at the arithmetic mean
sales price during the applicable reporting period generally
achieved for such BII Product in all countries in which such sale
or other disposal occurred when such BII Product is sold alone and
not with other products (provided, however, that if such BII
Product is not sold alone in any country, then BII shall calculate
in good faith a hypothetical market price for the BII Product,
allocating the same proportion of costs, overhead and profit as are
then allocated to all similar substances then being made and
marketed by BII and having an ascertainable market price; provided,
however, that if BII in good faith disputes BII’s
calculation, the Parties shall submit the matter promptly for
resolution in accordance with the dispute resolution procedure
outlined in Article 12).
In the
event a BII Product is sold as a Combination Product or a
Co-Packaged Product, Net Sales of such Combination Product or
Co-Packaged Product will be calculated as follows:
(i)
In the case of
Combination Product and/or Co-Packaged Product, if the BII Product
and the other products therein are sold separately, Net Sales of
the BII Product
-8-
portion of
Combination Products and/or the Co-Packaged Products will be
calculated by multiplying the total Net Sales of the Combination
Product and/or Co-Packaged Product by the fraction A/(A+B), where A
is the average gross selling price in the applicable country in the
Territory of the BII Product sold separately in the same
formulation and dosage, and B is the sum of the average gross
selling prices in the applicable country in the Territory of all
other therapeutically or prophylactically active ingredients or
products in the Combination Product [***].
(ii)
If the Combination
Product and/or the Co-Packaged Product and the BII Product are sold
separately, but the average gross selling price of the other
product(s) cannot be determined, Net Sales of the Combination
Product or the Co-Packaged Product shall be equal to [***]. the Net
Sales of the Combination Product or Co-Packaged Product multiplied
by the fraction A/C wherein A is the average gross selling price of
the BII Product and C is the average gross selling price of the
Combination Product or Co-Packaged Product.
(iii)
If the Combination
Product and/or the Co-Packaged Product and the other product(s) are
sold separately, but the average gross selling price of the BII
Product cannot be determined, Net Sales of the Combination Product
and/or Co-Packaged Product shall be equal to the Net Sales of the
Combination Product and/or Co-Packaged Product multiplied by the
following formula: one (1) minus B/C wherein B is the average gross
selling price of the other product(s) and C is the average gross
selling price of the Combination Product and/or Co-Packaged
Product.
(iv)
If the Combination
Product or Co-Packaged Product are sold but the average gross
selling price of neither the BII Product nor the other product(s)
can be determined, Net Sales of the Combination Product or
Co-Packaged Product shall be equal to Net Sales of the Combination
Product or Co-Packaged Product multiplied by a mutually agreed
percentage.
The
average gross selling price for such other product(s) contained in
the Combination Product or Co-Packaged Product shall be calculated
for each Calendar Year [***]. In the initial Calendar Year during
which a Combination Product or Co-Packaged Product is sold, a
forecasted average gross selling price shall be used for BII
Product, other product(s), or Combination Product and/or
Co-Packaged Product. Any over or underpayment due to a difference
between forecasted and actual average gross selling prices shall be
paid or credited in the second Earn-Out-Payment payment of the
following Calendar Year. In the following Calendar Year the average
gross selling price of the previous Calendar Year shall apply from
the second Earn-Out-Payment payment on.
1.1.44
“Oxford Agreement” shall
mean the loan and security agreement between Oxford Finance LLC, a
Delaware limited liability company with an office located at ▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, (“Oxford
Finance LLC”), certain other lenders, MabVax Therapeutics,
Inc., a Delaware corporation with offices located at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇, and MabVax
Therapeutics Holdings Inc., dated as of January 15, 2016, as
amended, regarding the provision of certain loans to MabVax
Therapeutics Inc. and MabVax Therapeutics Holdings
Inc.
1.1.45
“Patent”
shall mean any and all (a) patents, (b) patent applications,
including all priority applications, provisional and
non-provisional applications, foreign patent application,
patent
-9-
cooperation treaty
(PCT) applications, substitutions, continuations,
continuations-in-part, divisions and renewals, and all patents
granted thereon, (c) all patents-of-addition, reissues,
re-examinations and extensions or restorations by existing or
future extension or restoration mechanisms, including supplementary
protection certificates or the equivalent thereof, (d)
inventor’s certificates, letters patent or (e) any other
substantially equivalent form of government-issued right
substantially similar to any of the foregoing described in
subsections (a)-(d) above.
1.1.46
“Patent
Files” shall mean any and
all files, books, records, patent application documents, inventor
assignment agreements and/or inventor reports, MABVAX claim(s) of
invention(s), and all other similar or like information that solely
and exclusively relate to the
[***] Program Patents.
1.1.47
“Phase I Clinical Trial”
means a human clinical trial conducted in any country that meets
the requirements of 21 CFR §312.21(a). By way of example and
not limitation, a Phase I Clinical Trial is usually performed as a
single or multiple dose Clinical Trial in healthy volunteers or
patients to assess specific administration, distribution,
metabolism, excretion (ADME), safety and tolerability,
bioavailability/bioequivalence or exploratory efficacy (in the
sense of demonstrating “proof-of-principle”) of an
investigational drug, and the emphasis in Phase I is usually on
safety and tolerability and it is typically used to plan patient
dosing in Phase II Clinical Trials. For clarity, a Phase I Clinical
Trial may also represent the initial phase of a combined Phase
Ib/II Clinical Trial.
1.1.48
“Phase III Clinical Trial”
means a human clinical trial conducted in any country that meets
the requirements of 21 CFR §312.21(c). By way of example and
not limitation, a Phase III Clinical Trial is a large scale
Clinical Trial (usually several hundreds of patients) performed
after preliminary evidence suggesting effectiveness of the drug has
been obtained in Phase II clinical studies, and it is intended to
gather the pivotal information about effectiveness and safety that
is needed to evaluate the overall benefit-risk relationship of the
drug and, along with other clinical trials, to provide an adequate
basis for Regulatory Approval. For clarity, a Phase III Clinical
Trial may also represent the second part of a combined Phase II/III
Clinical Trial.
1.1.49
“Recognized Agent” means
any Third Party who distributes products directly to customers
[***]
1.1.50
“Regulatory Approval”
means both: (a) the technical, medical and scientific licenses,
registrations, authorizations and approvals (including approvals of
NDAs and labelling approvals), and (b) any necessary pricing and/or
reimbursement authorizations and approvals, of any Regulatory
Authority necessary for the distribution, marketing, promotion,
offer for sale, use, import, export or sale of such pharmaceutical
product in such country.
1.1.51
“Regulatory Authority”
means any (a) governmental authority, notified bodies or other
organization in a country or region that regulates the manufacture
or sale of pharmaceutical or medicinal products or medical devices,
including the US Food and Drug Administration (or any succeeding
entity), Japan Pharmaceutical and Medical Device Agency (or any
succeeding entity) and the European Medicines Agency (or any
succeeding entity), and any successors thereto and (b) any other
relevant bodies authorized by Applicable Law to review or otherwise
exercise oversight over marketing authorization applications, other
regulatory filings or regulatory approvals.
1.1.52
“Sublicensees” means a
Third Party, [***] to whom BII (or its Affiliate or another of its
Sublicensees) grants a license or sublicense under any rights
transferred to BII under this Agreement to develop or commercialize
BII Products in the Territory. For the avoidance of doubt, if a
Third Party is solely granted the right to perform distribution
activities of BII Products in a country in the Territory, such
Third Party shall be considered a Third Party distributor in such
country.
-10-
1.1.53
“Start of
Development” or “SoD” shall mean with respect to a BII Product,
the formal decision [***].
1.1.54
“Taxes”
shall mean all forms of preliminary or finally imposed
taxation, domestic
and foreign, federal, state,
provincial, municipal, or other taxes, fees, levies, duties and
other assessments or charges of whatever kind (including without
limitation, sales, use, excise,
stamp, transfer, property, value added, recording, registration,
intangible, documentary, goods and services, real estate, payroll,
gains, gross receipts, withholding, and franchise taxes) together
with any interest, penalties, or additions payable in connection
with such taxes, fees, levies, duties and other assessments or
charges.
1.1.55
“Tax
Law” shall mean any
applicable law, rule or regulation of any Government Entity, or
judgment, order, writ, decree, permit or license of any Government
Entity of competent jurisdiction that, in each case, relates to
taxes or other similar assessments or charges of any kind
whatsoever (including, but not limited to, withholding on amounts
paid to any person).
1.1.56
“Term”
shall mean the period of time beginning on the Effective Date and
continuing until the expiration or termination of this Agreement,
whichever occurs first in time.
1.1.57
“Territory”
shall mean all of the countries in the world, and their territories
and possessions.
1.1.58
“Third
Party” means a person or entity other than (a) BII or any of
its Affiliates, or (b) MABVAX or any of its
Affiliates.
1.1.59
“[***]
Program” shall mean MABVAX’s research and development
program to identify and characterize antibodies that bind the [***]
antigen [***]
1.1.60
“[***]
Program Antibodies” shall mean all antibodies generated in
the course of the [***] Program at MABVAX, [***].
1.1.61
“[***]
Program Inventory” shall mean all inventory of product,
[***], wherever located, owned or controlled by MABVAX, including
without limitation all [***] Program Antibodies.
1.1.62
“[***]
Program Know-How” shall mean all Know-How, owned by MABVAX
that is solely and exclusively related to the [***] Program, [***]
owned by MABVAX and that solely relates to the [***]
Program.
1.1.63
“[***]
Program Patents” shall mean all Patents that are set forth in Schedule 1.1.63,
including all reissues, reexaminations, divisions, renewals,
extensions or supplementary protection certificates, provisionals,
continuations and continuations-in-part thereof (only to the extent
that such continuations-in-part claim inventions disclosed as
required by 35 U.S.C. § 112, in the parent application
thereof) and the like, and all patents issuing on the foregoing
patent applications, in all jurisdictions.
1.1.64
“[***]
Program Patent Assignment” shall mean the general assignment
of the [***] Program Patents from MABVAX to BII, which will be
substantially in the form attached as Exhibit C.
1.1.65
“Transaction
Documents” shall mean collectively: (a) this Agreement; (b)
the [***] Program Patent Assignment; (c) the ▇▇▇▇ of Sale; and (iv)
the Assignment and Assumption Agreement. The phrase “the
consummation of the transactions contemplated by this
Agreement” or such similar phrases includes the execution,
delivery, and performance of the Transaction
Documents.
-11-
1.1.66
“Valid
Claim” means with respect to a given jurisdiction, (a) a
claim within the a Patents, once issued, that has not expired or
been abandoned or been revoked, been declared invalid or
unenforceable by a court of competent jurisdiction in a final and
non-appealable judgment (or judgment from which no appeal was taken
within the allowable time period) or (b) a claim within a patent
application which application has not been pending for more than
[***] years from the date of its priority filing date and which
claim has not been irretrievably revoked, irretrievably cancelled,
irretrievably withdrawn, held invalid or abandoned by a patent
office, court or other governmental agency of competent
jurisdiction in a final and non-appealable judgment [***] or
finally determined to be unallowable in a decision from which an
appeal cannot or can no longer be taken. For clarity, a claim of an
issued patent that ceased to be a Valid Claim before it issued
because it had been pending too long, but subsequently issues and
is otherwise described by clause (a), shall be considered to be a
Valid Claim once it issues. The same principle shall apply in
similar circumstances such as if, for example (but without
limitation), a final rejection of a claim is overcome.
1.1.67
In
this Agreement a reference to:
()
a document in the
“agreed form” is a reference to a document in a form
approved and for the purposes of identification signed by or on
behalf of each Party;
(a)
a statutory provision includes a reference to the statutory
provision as modified or re-enacted or both from time to time
before the date of this Agreement and any subordinate legislation
made under the statutory provision before the date of this
Agreement;
(b)
a person includes a reference to a body corporate body,
association or partnership;
(c)
a person includes a reference to that person's
legal personal representatives and successors;
(d)
a clause,
paragraph or schedule, unless the context otherwise requires, is a
reference to a clause or paragraph of or schedule to this
Agreement;
(e)
MABVAX and BII may be referred to herein as a
“Party” if singular, and as “Parties” if
plural; and
(f)
The
headings in this Agreement do not affect its
interpretation.
2.
SALE
AND PURCHASE OF THE ACQUIRED ASSETS
2.1
Sale and Purchase. In
accordance with the terms and upon the conditions of this
Agreement, at the Closing, MABVAX will sell, convey, assign, and
transfer to BII, MABVAX’s entire right, title, and interest
in and to the Acquired Assets in the Territory free and clear of
Encumbrances, in exchange for payment by BII of the consideration
as described in Sections 5.1 – 5.4, and BII will purchase,
acquire, accept, and assume the Acquired Assets in the Territory.
For the avoidance of doubt, upon transfer of title to BII or its
designee, and subject to the terms and conditions of this
Agreement, BII shall have the sole and exclusive proprietary right,
as against MABVAX, to fully exploit the Acquired Assets worldwide
without restriction, and no rights in the Acquired Assets shall
remain with MABVAX. For the avoidance of doubt,(i) to the extent
books, records and other documents that otherwise correspond to the
definition of Books and Record in accordance with Section 1.1.11,
but do not relate solely and exclusively to the [***] Program but
also to other programs, MABVAX will provide to BII redacted copies
of such books, records and other
-12-
documents, and (ii) to the
extent patent files that otherwise correspond to the definition of
Patent Files in accordance with Section 1.1.44, but do not relate solely and
exclusively to the [***] Program but also to other program paying,
performing and discharging when due, and BII shall not assume or
have any responsibility for (a) all liabilities relating to or
arising out of the Excluded Assets, (b) all accounts payable, taxes
and other accrued expenses and/or obligations related to the [***]
Program arising and/or related to any act, omission, fact, and/or
matter prior to the Closing Date, (c) all obligations under the
[***] Agreement and the [***] Agreement, and (d) MABVAX’s
obligations under this Agreement (the “Excluded Liabilities”)s,
MABVAX will provide to BII redacted copies of such patent
files.
2.2
Assumption and Exclusion of
Liabilities. Upon the terms and subject to the conditions
set forth in this Agreement, BII shall assume, and agree to pay,
perform and discharge when due, any and all liabilities arising
from BII’s ownership, use or operation of the Acquired Assets
or the exploitation of the BII Products after the Closing Date (the
“Assumed
Liabilities”). MABVAX shall retain, and shall solely
be responsible for paying, performing and discharging when due, and
BII shall not assume or have any responsibility for (a) all
liabilities relating to or arising out of the Excluded Assets, (b)
all accounts payable, taxes and other accrued expenses and/or
obligations related to the [***] Program arising and/or related to
any act, omission, fact, and/or matter prior to the Closing Date,
(c) all obligations under the [***] Agreement and the Oxford
Agreement, and (d) MABVAX’s obligations under this Agreement
(the “Excluded
Liabilities”).
2.3
MABVAX Data Room. Within ten
(10) days of the Effective Date, MABVAX shall make available to BII
via the MABVAX Data Room (to the extent not already made available
to BII in the MABVAX Data Room as of the Effective Date) copies of
all: (a) [***]patent filing documents including employment
agreements providing IP assignment, assignment documents for all
relevant patent applications, lab notebook records, unpublished
patent applications, unpublished patent wrappers/prosecution
histories, agreements relating to the subject matter, publications
and public disclosures, and patents and legal related matters, and
(b) [***]program files, including without limitation publications,
manuscripts, and abstracts, meeting minutes, research plans and
program summaries, reports and presentations, the [***] Agreement,
and inventory lists, in each case (a) and (b), existing as of the
Effective Date. In addition, MABVAX shall provide an external
independent Third Party designated by BII and approved by MABVAX
(such approval not to be unreasonably withheld, delayed or
conditioned and provided that such external independent Third Party
shall be subject to customary obligations to keep MABVAX’s
Confidential Information received by it confidential) with one
complete version of the MABVAX Data Room content as of the
Effective Date, using an appropriate storage media (e.g., CD or
USB-stick), solely for the purpose to serve as evidence of the
information provided by MABVAX to BII prior to the Effective
Date.
3.
LICENSE
GRANT
3.1
[***] Program Related
Know-How and IP. MABVAX hereby grants BII [***]the Know-How
owned or otherwise controlled by MABVAX that is not [***] Program
Know-How, but is otherwise disclosed,
provided and/or made available in writing, visually, orally or in
electronic medium to BII and/or any of its Affiliates, whether
prior or after the Effective Date in connection with this
Agreement, and/or that is necessary to exploit the Acquired Assets
within the Field in the Territory, including but not limited to
further research, develop, make, have made, use, sell, offer for
sale, import, or otherwise commercialize the Acquired Assets and/or
any BII Product, as applicable, in the Field in the Territory (the
“[***] Program
License”). For clarity,
the Parties agree
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that the [***] Program License under this
Section 3.1 shall be [***] as far as the scope of the [***]
Program is concerned.
3.2
No Implied Right or License.
Except as explicitly provided herein, this Agreement does not
convey any property rights in or imply any license to the use of
any Intellectual Property and/or assets from MABVAX to
BII.
4.
[***] RIGHTS
4.1
[***] Agreement. Pursuant to the terms of the research and license
agreement between [***] and MabVax Therapeutics, Inc., dated [***],
as amended (the “[***]
Agreement”), [***], inter
alia, licensed certain of its biologic materials, intellectual
property and know-how relating to the [***] Program
(“[***]
Rights”) to MabVax
Therapeutics, Inc. as further described
therein.
4.2
S[***] Agreement. Prior to the
Closing, the Parties and [***] will execute an agreement (a)
confirming that during the term of the [***] Agreement, MABVAX will
continue to be solely responsible for all of its obligations
therein, including but not limited to any and all payment
obligations due by MABVAX to [***] and (b)
whereby BII and [***] will agree that [***] will not assert against
BII, its Affiliates, Sublicensees or its or their distributors or
independent contractors, any claims for infringement of such [***]
Rights based on the research, development, manufacture, use, sale,
offer for sale or license, or import of the Acquired Assets, and/or
any BII Product in the Field in the Territory (the
“S{***]
Agreement”).
5.
PAYMENT
5.1
Upfront Purchase Price. The
up-front purchase price for the Acquired Assets shall be
US dollars Four Million (US$ 4,000,000) (“Upfront Purchase Price”).
Subject to Section 14.4.2 (i)(d), the
Upfront Purchase Price shall be non-refundable and
non-creditable.
5.2
Payment of Purchase
Price. The Upfront Purchase
Price shall be due and payable upon Closing by BII to MabVax Therapeutics
Holdings Inc. BII will make such payment due hereunder by wire
transfer of immediately available funds within [***] Business Days
of the Closing Date and after
the receipt by BII of an original Invoice and of a duly signed
original of this Agreement.
5.3
Milestone Payments.
As further consideration for the sale
and transfer of the Acquired Assets, BII shall pay to MabVax
Therapeutics Holdings Inc. the following one-time, milestone
payments (each a “Milestone
Payment”) set forth below
upon the first occurrence of the applicable milestone event with
respect to the first BII Product, provided that each such Milestone
Payment shall be due only once. Each Milestone Payment shall be due
and payable to MabVax Therapeutics Holdings Inc. within [***]
Business Days after receipt of an Invoice from MabVax Therapeutics
Holdings Inc., which shall be provided to BII as soon as
practicable after BII has notified MabVax Therapeutics Holdings
Inc. that the particular milestone event has been achieved (whether
achieved by or on behalf of BII or any of its Affiliates or
Sublicensees). BII will notify MabVax Therapeutics Holdings Inc.
within [***] Business Days after it becomes aware of the
achievement of any milestone event for which a payment to MabVax
Therapeutics Holdings Inc. is required under this Section
5.3. It is hereby understood
that each Milestone Payment shall be paid
[***].
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|
Milestone Event
|
Milestone
Payment
|
|
Start
of Development of the first BII Product
|
[***]
|
|
Initiation
of first Phase I Clinical Trial [***]
|
[***]
|
|
Initiation
of first Phase III Clinical Trial [***]
|
[***]
|
|
First
Commercial Sale [***]in a Major Market
|
[***]
|
The Milestone Payment for the First Commercial
Sale [***] in a Major Market shall be payable [***], for the first
Calendar Year in which the First Commercial Sale milestone
event is achieved [***].
[***].
The First Commercial Sale Milestone Payment shall
be paid together with the Earn-Out-Payment of the Calendar Quarter
during which the First Commercial Sale milestone event
has been achieved.
5.4.2
Earn-Out
Period. BII’s
obligation to pay to MabVax Therapeutics Holdings Inc. the Earn-Out
Payment in the Territory shall begin, on a country-by-country and
BII Product-by-BII Product basis, with the First Commercial Sale of
such BII Product in such country and shall expire, the later of (a)
the expiration of the last to expire Valid Claim of a [***] Program
Patent covering the
composition of matter of such a BII Product or (b) [***]
years from the date of First Commercial Sale of such BII Product in such
country (the “Earn-Out
Period”).
5.4.3
No Multiple
Earn-Out-Payments. No multiple
Earn-Out Payments shall be payable because a BII Product, its
manufacture, use or sale is or shall be covered by more than one
Valid Claim included in the [***] Program Patents or more than one
patent under the [***] Program Patents.
(a)
Non-Patented Product. During
the applicable Earn-Out Period, if a BII Product sold in a country
in the Territory is not covered by a Valid Claim in such country at
the time of its sale, then the Earn-Out Payment for such BII
Product in such country shall be reduced by [***] percent ([***]%)
as determined pursuant to Section 5.4.1.
(b)
Third Party
Offset. During the Earn-Out
Period, if BII is required to (i) obtain a license grant from one
or more Third Parties under such Third Party’s patent rights
or other intellectual property in the absence of which a BII
Product could not legally be developed, have developed, made, have
made, used, offered for sale, sold or imported in a country in the
Territory and (ii) pay a royalty payment or other consideration
under such license grant
-15-
(including in connection with the settlement of a
patent infringement claim), then the Earn-Out Payment for
such BII Product in such country as
determined pursuant to Section 5.4.1 shall be reduced by
[***]percent ([***]%) of the amount
actually paid to the Third Party in such country in the same
Calendar Year.
(c)
Generic
Competition. The Earn-Out
Payment otherwise due under Section 5.4.1 shall be reduced, on a country-by-country
and BII Product-by-BII Product basis,
in the event of Generic Competition in a particular country of the
Territory to [***]per cent ([***]%) in any Calendar Quarter
in which there is Generic Competition for so long as the Generic Competition
exists.
(d)
Limits on
Deductions. Notwithstanding
anything to the contrary herein, in no event shall any deduction,
reduction or set off, individually or in the aggregate, as a result
of Sections 5.4.4(a), (b) and/or (c)
(each, a “Deduction”
and collectively, “Deductions”)
exceed [***]percent ([***]%) of the Earn-Out Payment determined
pursuant to Section 5.4.1
on a country-by-country and BII
Product-by-BII Product basis. On a
country-by-country and BII Product-by-BII Product
basis, BII shall be entitled to set
off any accrued but un-deducted Deductions from the previous
Calendar Years in the subsequent Calendar
Years.
5.4.5
Reports and Payments. Within
[***] days following the end of each Calendar Quarter, BII shall
submit to MabVax Therapeutics
Holdings, Inc. a written report of Net Sales of BII Products
sold by or on behalf of BII, its Affiliates and Sublicensees during
a Calendar Quarter in each country of the Territory in sufficient
detail to permit confirmation of the accuracy of the Earn-Out
Payment paid, and BII shall pay to MabVax Therapeutics Holdings, Inc., within
[***] days thereafter, all Earn-Out Payment payable by BII. If
applicable, by separate notice, BII will provide a confirmation
including gross sales and Net Sales of any and all BII Product on a
country-by-country basis (including calculation of Net Sales of
Combination Products or Co-Packaged Products ) in the currency for
which such BII Product was sold, and, if the currency of sale was
not US dollars, also in US dollars; an accounting of deductions
taken in the calculation of Net Sales; details of any royalty
credits taken on a Third Party licence-by-Third Party licence
basis; on a country-by-country basis, any reduction, including the
relevant market share data on the basis of which such reduction was
taken and the source of such data; the applicable exchange rate to
convert from each country’s currency to US dollars. BII shall
use the monthly average exchange rates used by BII throughout its
regular accounting system for the Calendar Quarter in which such
BII Products are sold.
5.4.6
Financial Audit. BII shall keep
(and shall cause its Affiliates and Sub-Licensees to keep) complete
and accurate records pertaining to the sale or other disposition of
BII Products in sufficient detail to permit BII to confirm the
accuracy of all Earn-Out Payment payments reported, for at least
[***] full Calendar Years following the end of the Calendar Year to
which they pertain. MabVax Therapeutics Holdings Inc. shall have
the right to cause an independent, certified public accountant
reasonably acceptable to BII (the “Auditor”) to audit
such records solely to confirm Net Sales, Milestone Payments and
Earn-Out Payments for a period
covering not more than the preceding [***] full Calendar Years,
provided that such audits may not be performed more than [***] a
year and only [***] per audited period. Such audits may be
exercised during normal business hours upon reasonable prior
written notice to BII. The Auditor will execute a reasonable
written confidentiality agreement with BII and will disclose to
MabVax Therapeutics Holdings Inc. only such information as is
reasonably necessary to provide MabVax Therapeutics Holdings Inc.
with information regarding any actual or potential discrepancies
between amounts reported and actually paid and amounts payable
under this Agreement. The report of the Auditor will include the
methodology and calculations used to determine the results, will be
delivered to BII and MabVax Therapeutics Holdings Inc. at the same
time, and will be final [***] Business Days after delivery to both
Parties,
-16-
it being understood
that BII will have the right during such [***] Business Day period
to discuss the report with the Auditor. In the event the Parties
are not in alignment after such [***] Business Day period, either
Party may refer this matter for resolution in accordance with the
defined dispute resolution procedure set forth in Article 13 within
[***] Business Days. MabVax Therapeutics Holdings Inc. shall bear
the full cost of such audit unless the report of the Auditor
discloses an underpayment by BII of more than [***] percent
([***]%) of the amount due for any Calendar Year, in which case BII
shall bear the full cost of such audit. BII shall pay the amount of
any underpayment disclosed in the undisputed Auditor’s
report, together with interest thereon to MabVax Therapeutics
Holdings Inc. within [***] days after delivery to the Parties of
the final Auditor’s report. If such final Auditor’s
report discloses an overpayment by BII of the amounts payable
hereunder, BII shall have the right to offset the overpayment
against the actual Earn-Out
Payment following the audit in question. Upon the expiration
of [***] full Calendar Years following the end of any Calendar
Year, the calculation of Earn-Out
Payment payments with respect to such Calendar Year shall be
binding and BII shall be released from any liability and obligation
with respect to payments for such year except in the case of fraud
or willful deceit.
5.4.7
Currency Conversion. All
Earn-Out Payments shall be payable in full in US dollars. Any sales
of BII Products incurred in a currency other than US dollars shall
be converted to the US dollars equivalent using a rate of exchange
that corresponds to the rate used by BII or any of its Affiliates
or Sublicensees recording such receipt or expenditure, for the
respective reporting period, related to recording such Net Sales or
expenses in its books and records that are maintained in accordance
with the applicable Accounting Standards consistently used by BII,
its Affiliates or their respective Sublicensees. If such party is
not required to perform such currency conversion for its respective
Accounting Standards reporting with respect to the applicable
period, then for such period such party shall convert its amounts
received and expenses incurred into US dollars using exchange rates
published by the ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ (▇▇▇), ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇.
For exchange rates not published by ECB an alternative source will
be agreed between the Parties. Any Earn-Out-Payment shall be
calculated based upon the US dollars equivalent calculated in
accordance with the foregoing.
5.5
Payment Terms. BII shall pay
all amounts payable under this Agreement as stated in the
respective sections, upon delivery to BII of an Invoice for such
amounts by MabVax Therapeutics
Holdings Inc.. All payments to be made by BII to
MabVax Therapeutics Holdings
Inc. under this Agreement shall be made in US dollars and may be paid by bank wire
transfer in immediately available funds to such bank account as may
be designated by MabVax Therapeutics
Holdings Inc. from time to time.
5.6
Taxes in general. Subject to
Section 5.7, all payments under or in connection with this
Agreement shall be inclusive of any Taxes and each Party shall be
responsible for and shall bear, pay or set-off its own Taxes
assessed by a tax or other authority except as otherwise set forth
in this Agreement.
5.7
VAT. All payments due to the
terms of this Agreement are expressed to be exclusive of value
added tax (VAT) or similar indirect taxes (e.g. goods and service
tax). VAT/indirect taxes shall be added to the payments due to the
terms if legally applicable.
5.8
Withholding Tax. If Applicable
Laws or regulations require withholding by BII and/or its
Affiliates of any taxes imposed upon MabVax Therapeutics Holdings Inc. on
account of any Earn-Out Payments and other payments paid under this
Agreement to benefit of MABVAX,
such taxes have to be retained by BII and/or its Affiliates as
required by local law from such remittable royalty and other
payment and shall be paid by BII and/or its Affiliates to the
proper tax authorities on account
-17-
of MabVax Therapeutics Holdings Inc. Official
receipts of payment of any retained local withholding tax shall be
secured and sent by BII and/or its Affiliates to MabVax Therapeutics Holdings Inc. as
evidence of such payment only on MabVax Therapeutics Holdings Inc.’s
request. The Parties shall cooperate and exercise their best
efforts to ensure that any withholding taxes imposed on
MabVax Therapeutics Holdings
Inc. are reduced as far as possible under the provisions of
any relevant double tax treaty. Withholding taxes retained by BII
and/or its Affiliates and paid to the proper German/local tax
authorities as well as a possible refund of retained and paid local
withholding taxes from the German/local tax authorities in favor of
MabVax Therapeutics Holdings
Inc. are paid in local/German currency (Local currency/EUR).
Any effect by currency conversion is benefit or burden of
MabVax Therapeutics Holdings
Inc. as tax-payer and are not refundable or taken by BII
and/or its Affiliates.
5.9
Interest on Late Payments. If
BII fails to pay any payment due under this Agreement as provided
herein on or before the date such payment is due, then such late
payment will bear interest, to the extent permitted by Applicable
Law, at an annual rate of [***] percent ([***]%) above the 1 month
EUR LIBOR rate which applied on the due date effective for the
first date on which payment was delinquent and calculated for the
exact number of days in the interest period based on a year of
three hundred sixty (360) days (actual/360). If the LIBOR is no
longer published, the Parties will agree upon another
internationally recognized rate which has historically been
substantially equivalent to the 1 month EUR LIBOR rate and utilize
such rate retroactively to such time as the rate was no longer
available.
5.10
Loss or Damage to the Acquired
Assets. Prior to the Closing, any loss or damage to the
Acquired Assets shall be the sole responsibility of
MABVAX.
5.11
Commercially Reasonable
Efforts. BII shall use Commercially Reasonable Efforts to
advance the development of at least one (1) BII Product into a
Phase I Clinical Trial. BII shall endeavour to achieve (a) Start of
Development of a BII Product within approximately [***] months
after the Effective Date, and (b) Initiation of the first Phase I
Clinical Trial of a BII Product approximately [***] months after
the effective date of the Agreement, it being understood by the
Parties these timelines are anticipated timelines only and are
neither binding nor enforceable under this Agreement. For the
avoidance of doubt, BII is permitted to suspend or stop the
development of a BII Product for a period that does not exceed
[***] months even as such suspension or stoppage would be a breach
of BII’s obligation to use Commercially Reasonable
Efforts.
5.12
S[***]Agreement.
Notwithstanding anything to contrary in this Agreement, the Parties
agree, that in the event BII makes any payments that are due under
this Article 5 to [***] and not to MabVax Therapeutics Holdings Inc. pursuant
to the [***] Agreement, such payments shall not be made by BII to
MabVax Therapeutics Holdings Inc.,
(or, for the avoidance of doubt, to MabVax Therapeutics
Inc.) under this Agreement.
6.
CLOSING
ACTIONS
TO BE TAKEN PRIOR TO OR AT CLOSING. ON OR AFTER THE EFFECTIVE DATE AND
PRIOR TO OR AT CLOSING, MABVAX SHALL DELIVER TO BII, DULY
EXECUTED:
6.1
The (a) ▇▇▇▇ of
Sale; (b) Assignment and Assumption Agreement, (c) [***] Program
Patent Assignment, and (d) written confirmation by [***] that the
Acquired Assets have been released, all lenders under the [***]
Agreement have expressed their consent to the transactions under
this Agreement, and that any of MABVAX’s obligations under
the [***] Agreement relating to the
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[***] Program
and/or the Acquired Assets have been fully satisfied and the
Acquired Assets are not and will not be Encumbered by the [***]
Agreement.
6.2
Certified
copies of any necessary corporate actions of MABVAX authorizing the
execution and performance of this Agreement and the consummation of
the transaction contemplated herein; and
6.3
Such
other documents as are necessary or desirable for MABVAX and BII to
transfer the Acquired Assets from MABVAX to BII and as far as
applicable the assignment of such documents.
6.4
Interdependence. The transfers
and deliveries described in this Article 6 are mutually
interdependent and are to be regarded as occurring simultaneously
as of the Closing Date. Unless agreed otherwise in writing by
MABVAX and BII, no such transfer or delivery shall become effective
until all other transfers and deliveries provided for in this
Article 6 have also become effective. The parties agree that the
failure of MABVAX to transfer and deliver to BII the [***] Program
Inventory upon Closing in accordance with Section 8.2.2 shall have no effect on the
effectiveness and validity of the other transfers and deliveries
provided for in this Article 6.
7.
REPRESENTATIONS
AND WARRANTIES
7.1.1
Authority. MABVAX has the power
and authority to execute and deliver this Agreement and to
consummate the transactions contemplated hereby. All corporate
proceedings on the part of MABVAX that are necessary to approve and
authorize the execution and delivery of this Agreement and the
consummation of the transaction contemplated hereby have occurred,
and assuming proper execution and delivery by BII, this Agreement
is enforceable against MABVAX in accordance with its terms. Each
Transaction Document will be enforceable in accordance with each of
its terms upon execution and delivery to BII, in each case, subject
to (a) applicable bankruptcy, insolvency, reorganization,
moratorium and similar laws affecting creditors rights and remedies
generally, and (b) the remedy of specific performance and
injunctive and other forms of equitable relief. There are no other
MABVAX Third Party consents or approvals necessary for MABVAX to
sell and transfer to BII the Acquired Assets as contemplated
hereby.
7.1.2
Finder’s Fees. Except for
those listed in Schedule
7.1.2, MABVAX has no liabilities or obligations to pay any
fees or commissions to any broker, finder, or other agent with
respect to the transactions contemplated by this Agreement for
which BII could become liable or obligated. For clarity, the
finder’s fee listed in Schedule 7.1.2 is borne by
MABVAX.
7.1.3
Authorizations. No
Authorization is needed by MABVAX for the execution, delivery, or
performance of this Agreement and the consummation of the
transactions contemplated hereby, except where the failure to
obtain such Authorization will not have a Material Adverse Effect
on this Agreement or the consummation of the transactions
contemplated hereby.
7.1.4
Litigation and Claims. In the
Territory, there is no Action pending or involving MABVAX, or to
the Knowledge of MABVAX, threatened against MABVAX related to the
Acquired Assets before any Governmental Entity. MABVAX has settled or will settle any claims of
inventors relating to the Acquired Assets and no remuneration is
due or otherwise payable to the inventor(s) of
the
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Acquired Assets, including any compounds, whether
or not such compounds are subject to existing patents, patent
filings, or patent applications that may be filed by BII subsequent
to the Effective Date.
7.1.5
Organization and Good Standing.
MABVAX is a corporation duly organized, validly existing, and in
good standing under the laws of the
United States of America and is duly authorized to do business
therein.
7.1.6
Title to Acquired
Assets. MABVAX
is the sole owner of the Acquired
Assets and has and will convey
to BII good and marketable title to all of the Acquired Assets free
and clear of Encumbrances. Except for Excluded Assets, the Acquired
Assets include all of the tangible properties, Patents and Know-How
and other assets owned by MABVAX that are solely and exclusively
related to the [***] Program.
7.1.7
Sufficiency. To the knowledge of MABVAX, the Acquired Assets
and the rights licensed pursuant to Section 3.1
are all of the assets and rights owned
or controlled by MABVAX which are necessary for BII to conduct the
[***] Program in substantially the manner conducted by MABVAX as of
the date hereof, other than (a) personnel, (b) items generally
categorized as corporate overhead, [***], and (c) the Excluded
Assets.
7.1.8
Books and
Records. To the Knowledge of
MABVAX the Books and Records are reasonably conceived in a manner as appropriate in
the international pharmaceutical industry. None of the Books and
Records are recorded, stored,
maintained, operated or otherwise wholly or partly dependent on or
held or accessible by any means (including without limitation, an
electronic, mechanical or photographic process computerized or not)
which are not under the exclusive ownership and direct control of
MABVAX.
7.1.9
Patent
Files. To the Knowledge of MabVax, the Patent Files
include all of the material
information necessary for BII to fully exploit the Acquired Assets
and are conceived in a reasonable manner as appropriate in the good
international pharmaceutical industry. To the Knowledge of MABVAX, none of the material
Patent Files is recorded, stored, maintained, operated or otherwise
wholly or partly dependent on or held or accessible by any means
(including without limitation, an electronic, mechanical or
photographic process computerized or not) which are not under the
exclusive ownership and direct control of
MABVAX.
7.1.10
Violations/Breaches.
To the Knowledge of MABVAX, the
execution and delivery of this Agreement and the consummation of
the transactions contemplated hereby do not or will not (a) violate
any Applicable Law, (b) result in a breach of any term of the
certificate of incorporation, by-laws or governing document of
MABVAX or (c) result in a breach of any contract, agreement, or
other instrument to which MABVAX is a party, except, in the
case of clause (c), as would not have a Material Adverse
Effect.
(a)
[***] Program
Patents. To the knowledge of MABVAX, each of the
[***] Program
Patents is valid
and enforceable, and nothing has been done or omitted to be done by
which it may cease to be valid and enforceable or which may
restrict the scope of protection afforded by such [***] Program Patents, and/or would justify
cancellation, rectification or other modification of a registration
of any of the [***] Program Patents. All [***] Program Patents are
legally and beneficially owned solely by MABVAX free and clear of
Encumbrances.
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(c)
MABVAX has not
received any written notice of any claim, legal action, proceeding,
judgment or settlement, and to the Knowledge of MABVAX’s
there is no threatened claim, relating to any of the [***] Program
Patents and/or [***] Program Know-How, including but not limited to
any claim or opposition as to title, validity, scope of protection,
enforceability, entitlement or otherwise.
(d)
All fees that have
become due and payable, including but not limited to renewal fees,
in respect to any [***] Program Patents have been paid and all
documents, recordations and certificates in connection with all
[***] Program Patents currently required to be filed have been
filed with the relevant patent office or other authorities in the
United States or foreign jurisdictions, as the case may be, for the
purposes of prosecuting, maintaining and perfecting all [***]
Program Patents.
(e)
There are no Third
Party challenges against the [***] Program Patents in oppositions,
nullity proceedings, re-examination proceedings or any other
proceedings that are pending. No supplier of any products or
services to MABVAX is a party to or to the best knowledge of MABVAX
has threatened with any civil, criminal, arbitration,
administrative or other claim or proceeding.
(g)
To the Knowledge of
MABVAX, there currently is, and has not been, no infringement of
any or the [***] Program Patents.
7.1.14
Third Party
Rights. To the
knowledge of MABVAX, the exploitation of the Acquired Assets does
not infringe any Patent or other Intellectual Property Right of
MABVAX or a Third Party and there are no existing or threatened
claims from third parties regarding the exploitation of the
Acquired Assets nor any contractual obligations or governmental
directions, orders or other regulations from any Governmental
Entity restricting the exploitation of the Acquired
Assets.
7.1.15
To the Knowledge of
MABVAX, all material Confidential Information owned or
used by MABVAX that is related
to the Acquired Assets are accurately recorded and accessible by and comprehensible to a
reasonable person experienced in the development, manufacture and
marketing of pharmaceutical or medicinal products. To the Knowledge
of MABVAX, it is not a party to a confidentiality or other
agreement that restricts the use or disclosure of information
solely and exclusively relates to the Acquired Assets. MABVAX has
not disclosed, except under appropriate confidentiality and non-use
obligations, any Confidential Information that relates to the
Acquired Assets to Third Parties.
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7.1.16
Complete Information.
To the Knowledge of MABVAX, all material information given by, or
on behalf of, MABVAX or to BII, its advisers or agents before
and/or during the negotiations leading to this Agreement and
including all information set out in this Agreement and any of the
Schedules attached to this Agreement, is true, complete, accurate
and not misleading. To the Knowledge of MABVAX, all information
about the Acquired Assets that might be material for disclosure to
a purchaser of the Acquired Assets have been disclosed to BII. As
far as MABVAX is aware, no information which it reasonably believes
to be material regarding the Acquired Assets (in particular its
financial condition, developments, prospects and liabilities) has
not been disclosed to BII.
7.1.17
Effects of Sale. Neither the execution nor performance of this
Agreement or a document to be executed at or before Closing
will:
(a)
result in MABVAX losing the benefit of a permit or
an asset, license, grant, subsidy, right or privilege which it
enjoys at the Effective Date in any jurisdiction relating to the
Acquired Assets; or
(b)
conflict with, or
result in a breach of, or give rise to an event of default under,
or require the consent of a person under, or enable a person to
terminate, or relieve a person from an obligation under, an
agreement, arrangement or obligation relating to the Acquired
Assets to which MABVAX is a party or a legal or administrative
requirement in any jurisdiction.
7.2
BII
represents and warrants to MABVAX as of the Effective Date and as
of the Closing Date that:
7.2.1
Authority. BII has the power
and authority to execute and deliver this Agreement and to
consummate the transactions contemplated hereby. All corporate
proceedings on the part of BII that are necessary to approve and
authorize the execution and delivery of this Agreement and the
consummation of the transaction contemplated hereby have occurred,
and assuming proper execution and delivery by MABVAX, this
Agreement is enforceable against BII in accordance with its terms,
and the other Transaction Documents will be enforceable in
accordance with their terms upon execution and delivery to MABVAX,
in each case, subject to (a) applicable bankruptcy, insolvency,
reorganization, moratorium and similar laws affecting creditors
rights and remedies generally, and (b) the remedy of specific
performance and injunctive and other forms of equitable
relief.
7.2.2
Authorizations. No
Authorization is needed by BII for the execution, delivery, or
performance of this Agreement and the consummation of the
transactions contemplated hereby, except where the failure to
obtain such Authorization will not have a Material Adverse Effect
on this Agreement or the consummation of the transactions
contemplated hereby.
7.2.3
Organization and Good
Standing. BII is a corporation
duly organized, validity existing, and in good standing under the
laws of Germany, and is duly authorized to do business
therein.
7.2.4
Violations/Breaches.
To the Knowledge of BII, the execution and delivery of
this Agreement and the consummation of the transactions
contemplated hereby do not violate any law, rule or regulation or
order, judgment, or decree within the Territory binding on BII, and
will not result in a breach of any term of the certificate of
incorporation, code of regulation or by-laws of BII or of any
contract, agreement, or other instrument to which any of BII is a
party.
7.3
If not otherwise
set forth herein the warranty shall be in line with Applicable
Law.
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8.
COVENANTS
8.1
Operation of the [***] Program Prior
to Closing. Except for actions taken pursuant to the prior
consent of BII, MABVAX from the Effective Date until Closing
will:
8.1.1
Conduct the [***]
Program in the ordinary course; and
8.1.2
Not transfer or Encumber any of the Acquired Assets;
and
8.1.3
Maintain all [***] Program Patents and [***] Program Know-How, including but
not limited to the maintenance and prosecution of [***]
Program Patents;
and
8.1.4
Continue
to meet the contractual obligations
of, and pay obligations relating to the Acquired Assets;
and
8.1.5
Not start litigation or arbitration proceedings relating to the [***]
Program; and
8.1.6
Notify BII immediately if it becomes aware of a
fact or circumstance which constitutes a breach of Section 8.1 or
has caused, or will or might cause, a warranty to become untrue,
inaccurate, incomplete or misleading at any time before
Closing;
and
8.1.7
Non-Impairment. MABVAX
will not act to impair the value of, or BII’s interest in,
the Acquired Assets, and will not use or infringe any Acquired
Assets in conducting its businesses in
the Territory. In particular, MABVAX will not abandon any of
the [***] Program Patents, cancel or narrow claims in any [***]
Program Patent, oppose any [***] Program Patents, challenge any
[***] Program Patents in nullity proceedings, re-examination
proceedings or otherwise challenge the validity or enforceability
of any of the [***] Program Patents.
8.1.8
Efforts to Close. With respect
to efforts to close, MABVAX and BII agree the following: MABVAX and
BII will cause all of the conditions, as specified in Articles 10
and 11 of this Agreement, to the obligations of the others to
consummate the transactions contemplated hereby, within [***] days
of the Effective Date of the Agreement.
8.1.9
MABVAX and BII
will comply fully with all applicable notification, reporting, and
other requirements of any applicable antitrust
laws.
8.1.10
MABVAX
and BII will each use all reasonable efforts to obtain, as soon as
practicable, the Authorizations that may be or become necessary for
the performance of their obligations under this Agreement and the
consummation of the transactions contemplated hereby, if any, and
will cooperate fully with each other in promptly seeking to obtain
such Authorizations.
8.2
Transfer of Acquired
Assets.
8.2.1
Within [***] Business Days
after the Effective Date, and in all cases by the Closing Date
should the Closing Date fall within the above [***] Business Days,
MABVAX shall make available to BII, or a party designated by BII,
all Books and Records and Patent Files. To the extent books,
records and other documents that otherwise correspond to the
definition of Books and Record in accordance with Section 1.1.11,
but do not relate solely and exclusively to the [***] Program but
also to other programs, MABVAX will provide to BII redacted copies
of such books, records and other documents, and to the extent
patent files that otherwise correspond to the definition of Patent
Files in accordance with Section 1.1.44, but do not relate solely
and exclusively to the [***] Program but also to other programs,
MABVAX will provide to BII redacted copies of such
patent
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files. . MABVAX
will store the originals of the Books and Records, including but
not limited to original lab notebooks, for access by both Parties
at a qualified storage facility located on San Diego, CA at
MABVAX’s cost and expense. Any copies of the Books and
Records and Patent Files shall be shipped to the address of BII
at:
Books and Records:
[***]
Boehringer
Ingelheim [***]
Tel:
[***]
Patent Files:
[***]
Boehringer
Ingelheim [***]
Tel:
[***]
8.2.2
Within [***]
Business Days after the Effective Date, and in all cases by the
Closing Date should the Closing Date fall within the above [***]
Business Days, MABVAX shall make available to BII, or a party
designated by BII, all [***] Program
Inventory, provided, at BII’s sole option, MABVAX may destroy
any such [***] Program Inventory in lieu of transferring such [***]
Program Inventory to BII in accordance with this Section
8.2.2.
8.2.3
On
the Closing Date, MABVAX shall make all other Acquired Assets,
including but not limited to copies of file wrappers for the [***]
Program Patents and written or tangible embodiments of the [***]
Program Know-How, available to BII, and will provide copies of
technical information used by MABVAX or Third Parties acting on
MABVAX’s behalf in the research work related to the [***]
Program, to the extent assigned by MABVAX to BII pursuant to this
Agreement. Such other documentation shall be provided in the format
as used by MABVAX or available and existing as of the Closing Date
and shall be shipped to the address of BII at:
[***]
Tel:
[***]
8.2.4
In
the event certain assets solely and exclusively related to the
[***] Program and existing as of the Closing Date have not been
specified as Acquired Assets and consequently have not been
assigned and transferred to BII at Closing, MABVAX shall promptly
assign and transfer such other assets once so identified, to BII
after Closing and such other assets so assigned and transferred
shall be treated as Acquired Assets for purposes of this
Agreement.
8.2.5
For the assignment
of the [***] Program Patents, MABVAX shall do all acts necessary to
vest in BII or its designated parties full and unrestricted
ownership in the [***] Program Patents, including those actions as
further described in Section 8.6.2.
8.2.6
Wrong Pockets; Further
Assurances. After the Closing,
in the event that MABVAX
receives or discovers that it is in possession of any asset that is
an Acquired Asset or is otherwise properly due and owing to BII in
accordance with the terms of this Agreement, MABVAX promptly shall
transfer such asset to BII. MABVAX shall provide (at no cost to
BII) reasonable and appropriate scientific expertise to support the
transfer of the technical aspects and Know How related to the
Acquired Assets to BII, for up to [***] weeks or a total of [***]
hours, whichever is first reached. The time can be spread across
appropriate MABVAX employees, to begin at a time mutually agreed to
by the Parties, and in all cases, to begin within [***] Business
Days after the Effective Date.
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8.3
Publicity. Any press releases,
financial filings, public announcements or similar publicity with
respect to this Agreement or the transaction contemplated hereby
shall be made upon the mutual consent of the Parties in advance of
publication. Exhibit
D attached
herein sets forth the final press release related to the execution
of this Agreement by both Parties, as approved by each Party for
public announcement on or after the Effective Date.
8.4
Cooperation in
Litigation. For a period of
five (5) years after Closing,
MABVAX and BII will, in the defense of any Third Party Action
relating to the Acquired Assets, communicate to the other Party any
facts of which such Party has knowledge with respect to the
Acquired Assets, testify in any legal proceedings, sign all
documents, make all rightful oaths and declarations, and make
available records to the extent reasonably necessary to permit the
effective defense or investigation of such Action at such other
Party’s sole cost and expense. If information other than that
pertaining to the Acquired Assets is contained in such records
and/or other communication, MABVAX and BII will either agree that
such information may be omitted or redacted by the producing party,
or will enter into appropriate secrecy commitments to protect such
information. For the avoidance of doubt, in the event of MABVAX
bankruptcy and/or liquidation, MABVAX’s Chief Executive
Officer and/or Chief Scientific Officer shall remain available for
the period of time indicated above as reasonably necessary to
permit the effective defense or investigation of any Third Party
Action relating to the Acquired Assets.
8.5
Expenses. Except as otherwise expressly provided in this
Agreement, whether or not the transactions contemplated by this
Agreement are consummated, each of MABVAX and BII shall bear its
own costs and expenses.
8.6
Assignment of
Patents.
8.6.1
Inventor Compensation. Each of
MABVAX and BII shall compensate each of its own Inventors according
to each of its own internal policy. No Party shall in any way be
responsible or liable for compensating the Inventors of another
Party.
8.6.2
Assignment and
Recordation. At BII’s
sole cost and expense, MABVAX will submit the appropriate
assignment documents to the relevant Governmental Entity, by
country, requesting that MABVAX’s entire right, title and
interest in the [***] Program Patents is transferred and assigned
solely to BII or a party designated by BII. MABVAX shall inform BII
in writing of these above submissions, including, without
limitation providing a copy of all communication sent to and
received from the Governmental Entities, within two (2) weeks of
their submission or receipt, and MABVAX shall on the Closing Date
provide BII with a signed and notarized [***] Program Patent
Assignment. MABVAX, at BII’s sole cost and expense, shall
promptly execute and deliver further documents and take such
further steps as may reasonably be required to vest in BII the
[***] Program Patents. Upon BII’s reasonable request and at
BII’s sole cost and expense, MABVAX shall execute and supply
documents necessary for BII’s prosecution and maintenance of
the [***] Program Patents that BII is unable to obtain without the
assistance of MABVAX, including, but not limited to declarations,
affidavits and inventor assignments, notarization and legalization
of documents, if necessary consularization of a respective country,
depose to or procure the deposing to or swearing of such documents
and do any act or thing and provide any information which may be
useful and necessary for the assignment of the [***] Program
Patents to BII.
8.6.3
BII shall be responsible for, and will pay all
out-of-pockets expenses (whether incurred before or after the
Closing Date) involved in notarization, authentication,
legalization, and/or consularization of the signatures of
BII’s representatives on the [***] Program Patent Assignment
and other [***] Program Patent assignment documents, by country,
and recording such assignment documents with the appropriate
Governmental Entities. BII will also be responsible for, and will
pay all expenses
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(whether incurred before or after the Closing
Date) involved in notarization, authentication, legalization,
and/or consultation of the signatures of MABVAX’s
representatives on the [***] Program Patent Assignment
documents.
8.6.4
Local
Patent Representatives.
MABVAX shall have responsibility, at
its own cost to:
(a)
With respect to the
[***] Program Patents: notify each in writing each of its local
patent representatives in the Territory within [***] Business Days
of the Closing Date that: (i) the [***] Program Patents have been
assigned to BII; and (ii) all future correspondence regarding the
[***] Program Patents should be sent to:
[***]
Tel:
[***]
(b)
Forward copies of any correspondence it receives
from its local patent representative or any Governmental Entities
regarding the [***] Program Patents to BII that it receives before or after the Closing
Date.
8.6.5
Maintenance of [***] Program
Patents. MABVAX will timely pay all out-of-pocket expenses
related to the maintenance of [***] Program Patents due between the
Effective Date and the Closing Date. After the Closing Date, BII
will be solely responsible for the maintenance of the [***] Program
Patents. If MABVAX receives any bills or invoices for expenses
related to the maintenance of [***] Program Patents after the
Closing Date, then MABVAX will forward to BII any such bills or
original invoices for payment by BII and MABVAX shall have no
liability for BII’s failure to timely pay such bills or
invoices.
8.6.6
Prosecution of [***]
Program Patents. MABVAX will
pay all bills and invoices for
[***] Program Patent prosecution expenses for activities or work
completed prior to the Closing Date and which relate to work
performed for the benefit of MABVAX. For clarity, work, whether
performed before or after the Closing Date, which relates to the
transfer of the [***] Program Patents to BII pursuant to this
Agreement shall not be “work performed for the benefit of
MABVAX”. Upon BII’s written request and at BII’s
expense, MABVAX will be responsible for Prosecuting the [***]
Program Patents for up to [***] days after the Closing Date;
provided, however, that “Prosecuting”
solely for the purposes of this Section 8.6.6
shall mean filing such documents as
may be reasonably necessary to continue the pendency of a patent
application for at least [***] days after the filing of such
document. Otherwise, BII will be responsible for Prosecuting the
[***] Program Patents as of the Closing Date. For a period of [***]
years after the Closing Date, MABVAX will further cooperate with
and reasonably assist and provide support to BII in relation to the
prosecution and maintenance of [***] Program Patents, at
BII’s request and expense. In the event that BII does not
have legal status in a [***] Program Patent because the recordation
process has not been completed, MABVAX shall upon instruction from
BII, act on BII’s behalf and at BII’s
expense.
8.6.7
Covenant Not to ▇▇▇. MABVAX
hereby agrees that with respect to any Patent or other Intellectual
Property that, on the date of Closing, they own or under which they
have the right to grant licenses, they will not assert against BII,
its Affiliates, Sublicensees or its or their distributors or
independent contractors, any claims for infringement of such Patent
or Intellectual Property based on the research, development,
manufacture, use, sale, offer for sale or license, or import of the
Acquired Assets, and/or any BII Product in the Field in the
Territory.
8.6.8
Non-Compete. After the Closing
Date until the [***] anniversary of the Closing Date, MABVAX
undertakes to BII that it shall not, and shall procure that its
Affiliates shall not, directly or indirectly conduct any activity
involving the research, development, commercialization or other
exploitation
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of a [***] Program
and/or any product competing with a BII Product, or fund, authorize
or assist any such activity.
8.6.9
Conditional No Challenge. To
the extent legally enforceable, MABVAX hereby agrees, so long as a
[***] Program Patent is pending or in force, neither to file any
Action that challenges the validity, enforceability or
patentability of such [***] Program Patent, nor to support any
Third Party to file such an Action; provided however, that none of
the foregoing shall apply to any Action (including counter-claims)
filed by MABVAX in the defense of an Action brought by BII or its
licensees against MABVAX alleging patent infringement. MABVAX shall
bind any of its assignees to this obligation.
8.7
Additional Records. Within a
reasonable time but no later than [***] days after Closing, MABVAX
will provide to BII copies of books, records, or other documents,
if any, which are not Books and Records, but which are necessary
for the operation of the [***] Program. MABVAX may redact from such
copies any information that does not relate to the [***] Program
and BII will have the right to use such copies only in connection
with its operation and ownership of the [***] Program.
9.
TREATMENT
OF CONFIDENTIAL INFORMATION
9.1
Confidential
Information of a Party disclosed by that Party to another Party
under this Agreement shall be received and held in confidence by
the receiving Party and, except with the consent of the disclosing
Party or as otherwise permitted under this Agreement, shall neither
be used by the receiving Party nor disclosed by the receiving Party
to others. For clarity, the terms and the existence of this
Agreement and the Transaction Documents shall be considered
Confidential Information of both Parties. MABVAX shall neither use
nor disclose to Third Parties any Confidential Information related
to the Acquired Assets.
9.2
A receiving Party
may disclose and authorize the use of the disclosing Party’s
Confidential Information (a) to and by its Affiliates, consultants,
advisors, and agents only to the extent necessary to carry out the
Party’s rights and responsibilities under this Agreement, (b)
in the course of the consummation of the transactions contemplated
hereby, or (c) to actual or potential investors, acquirors,
licensees or sublicensees, as applicable, provided however, that
the receiving Party will ensure that said Affiliates, consultants,
advisors, agents, actual or potential investors, acquirors,
licensees or sublicensees, as applicable, are bound to such Party
by obligations of confidentiality and limited use at least as
restrictive as the obligations of such Party under this
Agreement.
9.3
The Parties agree
to take or cause action to be taken to preserve the confidentiality
of Confidential Information received from another Party as it would
customarily take to preserve the confidentiality of its own
Confidential Information, using in all such circumstances, not less
than reasonable care.
9.4
Except
as required by law and subject to Sections 8.3 and 9.2 above,
neither Party will disclose the terms of this Agreement without the
written consent of the other Party.
9.5
In the event disclosure of Confidential
Information is required by Applicable Law or rules of a security
exchange, then the disclosing Party will provide reasonable advance
written notice to the other Party of the timing, nature, and
content, of the anticipated disclosure, and shall use its
reasonable efforts to assist the disclosing Party in objecting to such request. If
the receiving Party is compelled to disclose any of the
Confidential Information pursuant to such legal or governmental
proceeding or Applicable Law or rules, receiving Party shall use
its
-27-
reasonable efforts to assist disclosing Party in
obtaining confidential treatment for such disclosed Confidential
Information. Any Confidential Information so disclosed shall still
be subject to the terms of this Agreement.
9.6
If this Agreement is, for any reason, terminated
prior to Closing, then BII agrees to promptly return to MABVAX, or
will promptly destroy, any tangible written, printed, visual or
digital media, or any other materials or substances, containing
Confidential Information,
including all copies and excerpts thereof except for one archival
copy, to be retained by BII in a secure manner for archival
purposes only. The return of such media or materials shall not
affect the obligations of BII as to confidentiality or non-use as
set forth herein.
9.7
For the sake of clarity, any and all of
MABVAX’s Confidential Information included in the Acquired
Assets transferred to BII at Closing, with the exception only of
Books and Records which are stored in accordance with
Section 8.2.1 above, which constitute Confidential Information
of both Parties, will no longer be considered MABVAX’s Confidential Information after
Closing, but will thereupon be BII’s Confidential Information
that MABVAX will be obligated to protect in accordance with the
provisions of this Article 8.
9.8
The Parties
undertake to protect Confidential Information (including but not
limited to patent-relevant, scientific or technical information)
against unauthorized access by Third Parties. If Confidential
Information is communicated via internet mail, use of internet mail
encryption technology is compulsory (for direct communication
between the Parties, BII provides for a suitable technology at
▇▇▇▇://▇▇▇▇▇▇.▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇▇.▇▇▇/.
free of charge).
9.9
Survival. This Article 9
shall survive the expiry or termination of this Agreement and shall
remain in full force and effect for [***] years after the expiry or
termination of this Agreement, except that any the obligations with
respect to Confidential Information that is a trade secret under
Applicable Law shall continue to survive thereafter.
All obligations of MABVAX to sell and transfer to
BII the Acquired Assets, to grant the rights under Section
3.1, and
to perform any other action at the Closing are subject to the
fulfilment, prior to or at the Closing, of each of the following
conditions, of which Sections 10.2 and 10.3 may be waived by
MABVAX, in whole or in part, without notice of such waiver to
BII.
10.1
No Injunction/Order. No
preliminary or permanent injunction or other order will have been
issued that would make unlawful the consummation of the
transactions contemplated by this Agreement.
10.2
Performance of
BII’s Obligations. BII
will have fully performed all commitments required by this
Agreement to be performed prior to Closing (except for those which,
in the aggregate, will not have a Material Adverse Effect on this
Agreement or the consummation of the transactions contemplated
hereby).
10.3
BII’s
Representations
and
Warranties True. All
representations and warranties of BII contained in this Agreement
will be true and correct as of the Closing, except for those which,
individually or in the aggregate, will not have a Material Adverse
Effect on this Agreement or the consummation of the transactions
contemplated hereby.
-28-
All obligations of BII to purchase the Acquired
Assets, to assume the Assumed Liabilities, to obtain the rights
under Section 3.1, and
to perform any other action at the Closing, are subject to the
fulfilment, prior to or at the Closing, of each of the following
conditions, of which Sections 11.2 and 11.3 may be waived by BII,
in whole or in part, without notice of such waiver to
MABVAX.
11.1
No Injunction/Order. No
preliminary or permanent injunction or other order will have been
issued that would make unlawful the consummation of the
transactions contemplated by this Agreement.
11.2
Performance of
MABVAX’s Obligations. MABVAX will have fully performed all commitments
required by this Agreement to be performed prior to Closing (except
for those which, in the aggregate, will not have a material adverse
effect on this Agreement or the consummation of the transactions
contemplated hereby) and will have tendered at the Closing, the
documents required in Section 6.1.
11.3
MABVAX’s Representations and
Warranties. All representations
and warranties of MABVAX contained in this Agreement will be true
and correct as of the Closing, except for those which, individually
or in the aggregate, will not have a Material Adverse Effect on
this Agreement or the consummation of the transactions contemplated
hereby.
11.4
[***] Agreement. [***], MABVAX
and BII shall have executed the [***] Agreement in the form set
forth in Schedule
11.4.
11.5
[***] Agreement. MABVAX will
have provided BII with the written confirmation by [***] that the
Acquired Assets have been released, all lenders under the [***]
Agreement have expressed their consent to the transactions under
this Agreement, any of MABVAX’s obligations under the [***]
Agreement relating to the [***] Program and/or the Acquired Assets
have been fully satisfied, and the Acquired Assets are not and will
not be Encumbered by the [***] Agreement.
12.
INDEMNITY
AND LIMITATIONS OF LIABILITY
12.1
Survival of Representations and
Warranties. The representations and warranties of MABVAX
contained in Article 7 of this Agreement and the other Transaction
Agreements shall survive the Closing and MABVAX shall remain liable
in that regard until the date which is twenty-four (24) months
after the Closing with the exception of the representation and
warranties contained in Sections 7.1.6, 7.1.7,
7.1.11(a), 7.1.11(b), and 7.1.11(f), which shall survive the termination
and expiration of this Agreement. The representations and
warranties of BII contained in this Agreement and the other
Transaction Agreements shall survive the termination and expiration
of this Agreement.
12.2.1
Subject to the
terms and conditions of this Agreement, MABVAX will defend and hold
BII harmless from and against all claims, losses, liabilities,
damages, costs, and expenses (including without limitation
reasonable fees and expenses of attorneys incurred in investigation
or defense of any third party Action) as a result of a Third Party
claim arising out of or related to an Excluded Liability or
material breach of an obligation, representation and warranty or
covenant of MABVAX in this Agreement.
12.2.2
Promptly, but no later than [***] days, after
receipt by BII of notice of any third party Action in respect of
which indemnity may be sought against MABVAX hereunder (for
purposes of this
-29-
Section 12.2.2, a “BII’s
Assertion”), BII will
notify MABVAX in writing of the BII’s Assertion, but the
failure to so notify MABVAX will not relieve MABVAX of any
liability they may have to BII, except to the extent MABVAX have
suffered actual prejudice thereby. MABVAX will be entitled to
participate in and, to the extent MABVAX elects by written notice
to BII within [***] days after receipt by MABVAX of notice of such
BII’s Assertion, to assume the defense of such BII’s
Assertion, at MABVAX’s own expense, with counsel chosen by it
which will be reasonably satisfactory to BII. With respect to any
such BII’s Assertion, BII will promptly provide MABVAX with:
(i) notice and copies of any documents served upon BII; and (ii)
all reasonable cooperation which MABVAX deem necessary to defend
such BII’s Assertion, including without limitation, providing
MABVAX and their outside attorneys access to any potentially
relevant documents, information, or individuals within the control
of BII, other than any privileged documents. If business
information of BII other than that pertaining to the [***] Program
is contained in such documents or information, MABVAX and BII will
enter into appropriate secrecy commitments to protect such
documents or information. Notwithstanding that MABVAX may have
elected by written notice to assume the defense of any BII’s
Assertion, BII will have the right to participate in the
investigation and defense thereof, with separate counsel chosen by
BII, but in such event the fees and expenses of BII (above those
which would otherwise have been incurred) and such separate counsel
will be paid by BII.
12.2.3
Notwithstanding
anything in this Section
12.2 to
the contrary:
()
MABVAX will have no
obligation with respect to any BII’s Assertion if, in
connection therewith, BII, without the written consent of MABVAX,
settles or compromises any Action or consents to the entry of any
judgment; and
(a)
MABVAX will not, without the written consent of
BII with respect to any BII’s Assertion:
()
Settle or
compromise any Action or consent to the entry of any judgment which
does not include as an unconditional term thereof the delivery by
the claimant or plaintiff to BII of a duly executed written release
of BII from all liability in respect of such Action, which release
will be reasonably satisfactory in form and substance to counsel
for BII; and
(i)
Settle or compromise any Action in any manner
that, in the reasonable judgment of BII or its counsel, will materially
adversely affect BII other than as a result of money damages or
other money payments.
(b)
Upon the payment of any settlement or judgment
pursuant to this Section 12.2, with
respect to any BII’s Assertion, MABVAX will be subrogated to
all rights and remedies of BII,
against any Third Party in respect of such BII’s Assertion,
to the extent of the amount so paid by MABVAX.
12.3.1
Subject to the
terms and conditions of this Agreement, BII will defend and hold
MABVAX harmless from and against all claims, losses, liabilities,
damages, costs, and expenses (including without limitation
reasonable fees and expenses of attorneys incurred in investigation
or defense of any third party Action) as a result of a Third Party
claim arising out of the Assumed Liabilities,
-30-
and/or a material
breach of an obligation, representation and warranty or covenant of
BII in this Agreement.
12.3.2
Promptly, but no later than [***] days, after
receipt by MABVAX of notice of any third party Action in respect of
which indemnity may be sought against BII hereunder (for purposes
of this Section 12.3, a
“MABVAX’s
Assertion”), MABVAX will
notify BII in writing of the MABVAX’s Assertion, but the
failure to so notify BII will not relieve BII of any liability they
may have to MABVAX, except to the extent BII has suffered actual
prejudice thereby. BII will be entitled to participate in and, to
the extent BII elects by written notice to MABVAX within
[***] days after receipt by BII
of notice of such MABVAX’s Assertion, to assume the defense
of such MABVAX’s Assertion, at BII’s own expense, with
counsel chosen by it which will be reasonably satisfactory to
MABVAX. With respect to any such MABVAX’s Assertion, MABVAX
will promptly provide BII with: (a) notice and copies of any
documents served upon MABVAX; and (b) all reasonable cooperation
which BII deems necessary to defend such MABVAX’s Assertion,
including without limitation, providing BII and their outside
attorneys access to any potentially relevant documents,
information, or individuals within the control of MABVAX, other
than any privileged documents. If business information of MABVAX
other than that pertaining to the [***] Program is contained in
such documents or information, MABVAX and BII will enter into
appropriate secrecy commitments to protect such documents or
information. Notwithstanding that BII may have elected by written
notice to assume the defense of any MABVAX’s Assertion,
MABVAX will have the right to participate in the investigation and
defense thereof, with separate counsel chosen by MABVAX, but in
such event the fees and expenses of MABVAX (above those which would
otherwise have been incurred) and such separate counsel will be
paid by MABVAX.
12.3.3
Notwithstanding
anything in this Section
12.3 to
the contrary:
()
BII will have no
obligation with respect to any MABVAX’s Assertion if, in
connection therewith, MABVAX, without the written consent of BII,
settles or compromises any Action or consents to the entry of any
judgment; and
(a)
BII will not,
without the written consent of MABVAX with respect to any
MABVAX’s Assertion:
()
Settle or
compromise any Action or consent to the entry of any judgment which
does not include as an unconditional term thereof the delivery by
the claimant or plaintiff to MABVAX of a duly executed written
release of MABVAX from all liability in respect of such Action,
which release will be reasonably satisfactory in form and substance
to counsel for MABVAX; and
(i)
Settle or
compromise any Action in any manner that, in the reasonable
judgment of MABVAX or their counsel, will materially adversely
affect MABVAX other than as a result of money damages or other
money payments.
(b)
Upon the payment of
any settlement or judgment pursuant to this Section12.3 , with respect to any MABVAX’s
Assertion, BII will be subrogated to all rights and remedies of
MABVAX, against any third party in respect of such MABVAX’s
Assertion, to the extent of the amount so paid by BII.
-31-
12.4
Indemnification
Limitations. The total aggregate amount in respect of which the
Parties shall be liable for indemnification under any provision of
Section 12.2 or 12.3 respectively shall not exceed, in the
aggregate three (3) times the amount actually received by MabVax
Therapeutics Holdings Inc. from BII under this Agreement except for
liabilities arising from or related to acts or omissions of gross
negligence or wilful misconduct by a Party.
12.5
Damage Limitations. In the
event any Claim or Action hereunder results in a Tax benefit or is
an insured loss to the indemnified Party, the indemnifying Party
will be entitled to take a credit against any liability thereunder
in the amount by which any Taxes of the indemnified Party will be
reduced by reason of any deduction or adjustment allowed the
indemnified Party for any payment, settlement, satisfaction of such
claim, as well as in the amount of and to the extent of any
insurance proceeds to which the indemnified Party is entitled. For
purposes hereof, it will be presumed that the maximum possible Tax
benefit is derived in the shortest time period
possible.
13.
DISPUTE
RESOLUTION
13.1
Any Claim arising
out of or related to this Agreement, and/or the Transaction
Documents, including without limitation, any Claim for
indemnification pursuant to Article 12 hereof will be resolved
pursuant to the procedures set forth in this Article
13.
13.2
Should any Claim
arise, MABVAX and BII will first attempt to resolve such Claim
amicably by entering into good faith negotiations by or among their
appropriate employees or officers. Such negotiations will commence
as soon as practicable after MABVAX and BII have each received
written notice of such Claim, but no later than [***] Business Days
after such receipt, and will terminate [***] days after such
commencement.
13.3
Any
Claim which is not resolved by the procedure set forth in Section
13.2 herein, will be referred to the Executive Official (or their
successor or designee) of MABVAX and BII. Such negotiations will
commence as soon as practicable after termination of the
negotiations described in Section 13.2, but not later than [***]
Business Days after any Party provides written notice to the others
that such Claim is not resolved and that they wish to invoke the
procedures set forth in this Section 13.3, and such negotiations
will terminate [***] days after commenced.
13.4
Any Claim which has not been resolved by the
procedures set forth in Sections 13.3 shall be finally resolved by binding arbitration in accordance with
the ICC arbitration rules by three (3) arbitrators. No arbitrator
shall be an employee, director or shareholder of either Party or
any of their Affiliates but each shall have substantial experience
in commercial disputes in the pharmaceutical industry. The
chairperson shall be a lawyer and not be a national of the country
of one of the Parties. Each Party shall name one arbitrator, and
such named arbitrators shall select the third arbitrator. Place of
such arbitration shall be [***]. The language of the arbitration
proceeding shall be English. The Parties acknowledge that they
desire for any arbitration to be conducted in an efficient, speedy
and economical manner.
13.5
The award for arbitration shall be final and
binding and may be enforced in any court of competent jurisdiction
against either Party. Notwithstanding the foregoing, the Parties
shall each be entitled
either prior to or during arbitration to seek and obtain
injunctive or other equitable relief in any
-32-
court of competent
jurisdiction to preserve the status quo pending arbitration or to
prevent the breach of this Agreement.
13.6
Except to the
extent necessary to confirm or obtain judgment on an award or
decision or as may be required by Applicable Law, neither Party
may, and the Parties shall instruct the arbitrators not to,
disclose the existence, content, or results of a dispute without
the prior written consent of the other Party.
14.1
Term. This Agreement shall
become effective as of the Effective Date and shall remain in full
force and effect unless terminated earlier in accordance with this
Article 14.
14.2
Termination prior to
Closing.
14.2.1
Termination for Breach. Either
Party shall be entitled to terminate this Agreement at any time
prior to Closing upon written notice if the other Party is in
material breach of its obligations under this
Agreement.
14.2.2
Termination for Delay in
Closing. This Agreement may be
terminated at any time by either Party, if the Closing has not
occurred within [***] days after the Effective Date. In case either
Party seeks to terminate this Agreement pursuant to this Section
14.2.2, such Party shall provide [***] days written notice to the
other Party, such notice not to be dated prior to the [***] day
after the Effective Date.
14.2.3
Termination in view of
Governmental Ruling. This
Agreement may be terminated at any time prior to Closing by any
Party not in default, if any Governmental Entity has issued a
final, non-appealable order, decree, or ruling permanently
enjoining or prohibiting the consummation of the transactions
contemplated by this Agreement. A Party seeking to terminate this
Agreement pursuant to this Section 14.2.3 shall provide [***]
Business Days written notice to the other Party which shall include
a copy of the writing evidencing such order, decree or
ruling.
14.3
Termination after
Closing.
14.3.1
Termination by BII for
Discontinuation. BII shall have
the right, at any time,
to terminate this Agreement if BII, or
its Affiliates decide, at their sole discretion, to discontinue
BII’s or its Affiliates’ activities with regard to the
[***] Program, including without limitation the discontinuation of
research, development or commercialization of the Acquired Assets
and/or BII Products, upon [***] days prior written notice to
MABVAX.
14.3.2
Termination for Breach
of Covenants. BII shall be
entitled to terminate this Agreement at any time, if MABVAX does
not fulfill its contractual obligations under Article 8 after
Closing, and provided MABVAX does not cure such non-fulfillment of
its contractual obligations within [***] Business Days after
receipt of written notice from BII regarding such nonfulfillment.
However, such cure is not possible in case of MABVAX’s non fulfillment of the contractual
obligations has caused an impairment of the Acquired Assets as
solely determined by BII.
-33-
a Material Adverse
Effect, and provided MABVAX does not
cure the alleged breach of such warranty within [***] Business Days
after receipt of written notice from BII regarding such breach of
warranty. However, such cure is not possible in case
of MABVAX’s breach of warranty has caused an
impairment of the Acquired Assets as solely determined by
BII.
14.3.4
Termination for Breach
at any Time. This Agreement may
be terminated at any time after Closing by any Party, if the other
Party (the “Defaulting
Party”) is in default of
any of its material obligations under this Agreement,
including without limitation a breach
of the confidentiality and non-use obligations set forth under
Article 9 of this Agreement (“Default”)
which Default remains uncured for [***] days, each measured from
the date written notice of such Default is provided to the
Defaulting Party. The Party terminating the Agreement based on this
Section 14.3.4 (the “Non-Defaulting
Party”) shall provide
written notice to the Defaulting Party, which notice shall identify
the Default, the intent to so terminate and the actions or conduct
that it considers would be an acceptable cure of such Default. In
case the Defaulting Party disputes the Default under this
Section 14.3.4,
then the issue of whether the Non-Defaulting Party may properly
terminate this Agreement on expiration of the applicable cure
period shall be resolved in accordance with Article 13 of this
Agreement. If, as a result of such dispute resolution process, it
is determined that the alleged Defaulting Party committed a Default
and that the Default has not been cured prior to such
determination, then the Agreement, subject to the limitation in
this Section 14.3.4,
shall be terminated effective as of the determination unless the
arbitration tribunal as set forth in Article 13 of this Agreement
determines that the Default is of a nature that can be cured within
[***] days after the date of such judgment and indicates what
minimal actions need to be completed with such time period (the
“Additional Cure
Period”) to cure the
Default. In this latter case, the termination shall be effective as
of the expiration of the Additional Cure Period unless the
Defaulting Party completes the required actions on or prior to such
date. If the Parties dispute whether such Default was so cured,
either Party alone may request the same court to determine whether
it was so cured, and the Parties shall cooperate to allow such
determination to be made within [***] Business Days after such
request by either Party. The dispute resolution proceeding
contemplated above in this Section 14.3.4
does not suspend any obligations of
either Party hereunder, and each Party shall use reasonable efforts
to mitigate any damages resulting from a Default. If as a result of
such dispute resolution proceeding it is determined that the
alleged Defaulting Party did not commit the alleged Default (or
such Default was cured in accordance with this Section
14.3.4 prior to or during the Additional Cure Period),
then no termination shall be effective, and this Agreement shall
continue in full force and effect.
Notwithstanding
the foregoing, MABVAX shall not have the right to terminate this
Agreement for BII’s Default following [***], provided that
BII pays MABVAX the amount of such damages that have been awarded
by a dispute resolution proceeding pursuant to Article 13 and
without prejudice to any other remedies MABVAX may have under
Applicable Law.
14.4
Effects of Termination.
(a)
This Agreement
shall become void and have no effect, and no Party hereto shall
have any liability to the other party hereto or their respective
Affiliates, directors, officers or employees;
-34-
(b)
All licenses
granted by a Party to the other Party under this Agreement shall
immediately terminate;
(c)
BII
shall return the original Acquired Assets to MABVAX as transferred
under this Agreement. [***]
(d)
Upon either Party’s request the other Party shall
promptly (i) return to the requesting Party any and all
Confidential Information of such requesting Party; or (ii) destroy
such Confidential Information of such requesting Party and certify
the destruction to such requesting Party within [***] calendar days
upon such requesting Party’s request according to this
Section (d), save
that each Party may retain one copy of the other Party’s
Confidential Information for the sole purpose of monitoring its
legal compliance with this Agreement, provided that the obligations
of confidentiality and non-use under Article 9 shall continue to
apply to such copies.
(i)
Terminate the Agreement in which case the following effects shall
apply:
(a)
This Agreement
shall become void and have no effect, and no Party hereto shall
have any liability to the other party hereto or their respective
Affiliates, directors, officers or employees;
(b)
All licenses granted by a Party to the other Party
under this Agreement shall immediately
terminate;
(c)
BII
shall return the original Acquired Assets to MABVAX as transferred
under this Agreement. [***]
(d)
MABVAX will refund to BII the Upfront Purchase
Price previously paid by BII to MABVAX under Section
5.1,
solely in the event that BII terminates this Agreement pursuant to
Section 14.3.2– 14.3.4,
(i) for MABVAX’s breach of its obligation to transfer to BII
the [***] Program Inventory pursuant to Section 8.2.2. and
this breach is not cured within [***] Business Days after the
Effective Date, or (ii) for MABVAX’s failure to sell,
convey, transfer, assign and deliver to BII MABVAX’s entire
right, title and interest in, to and under the Acquired Assets free
and clear of Encumbrances;
and
(e)
Upon either Party’s request the other Party shall
promptly (i) return to the requesting Party any and all
Confidential Information of such requesting Party; or (ii) destroy
such Confidential Information of such requesting Party and certify
the destruction to such requesting Party within [***] calendar days
upon such requesting Party’s request according to this
Section 14.4.1(d),
save that each Party may retain one copy of the other Party’s
Confidential Information for the sole purpose of monitoring its
legal compliance with this Agreement, provided that the obligations
of confidentiality and non-use under Article 9 shall continue to
apply to such copies.
,
or
(ii) apply as
an alternative remedy to the termination right pursuant to
Section 14.4.2(i)
and without consideration (except as otherwise stated below) in
lieu of termination of this Agreement:
-35-
(a)
BII may retain all
of its licenses and other rights granted under this Agreement,
subject to all of its payment and other obligations; except that
the applicable Milestone Payments and the applicable Earn-Out
Payment rate payable thereafter under this Agreement shall be
reduced by [***] percent [***] and
(b)
Any BII Confidential Information provided to MABVAX pursuant to this
Agreement will be promptly returned to BII or destroyed, as
requested by BII.
For the avoidance of doubt, except as set forth in
this Section 14.4.2, in
the event BII exercises the alternative remedy set forth below in
this Section 14.4.2(ii), all rights and obligations of BII under this
Agreement shall continue unaffected upon Default by MABVAX, unless
this Agreement is subsequently terminated by either Party pursuant
to another termination right under this Article 14, as applicable,
after BII exercises its rights pursuant to this Section
14.4.2(ii).
14.4.3
Rights Accruing Prior
to Expiration or Termination. Termination of this Agreement shall not relieve
the Parties of any obligation accruing prior to such termination.
Any termination of this Agreement shall be without prejudice to the
rights of either Party against the other accrued or accruing under
this Agreement or otherwise under Applicable Law prior to
termination, including the obligation to pay for any amounts that
accrued prior to the effective date of such termination. The
damages recoverable by the Non-Defaulting Party shall include all
attorneys’ fees reasonably incurred by such
party.
15.
MISCELLANEOUS
15.1
Applicability. The obligations
and restrictions contained in the provisions of this Agreement
shall apply to any and all consultants, subcontractors, agents,
independent contractors, or other individuals employed by a Party
to achieve performance under this Agreement.
15.2
Assignment. Neither this Agreement nor any right or
obligation hereunder may be assigned or otherwise transferred, in
whole or in part, by any Party without the prior express written
consent of the other Party, such consent not to be unreasonably
withheld or delayed; provided, however, that a Party may, without
the written consent of the others, assign this Agreement and its
rights and obligations hereunder (a) to an Affiliate provided that
the assigning Party shall remain liable for the performance of such
Affiliate, or (b) in connection with a merger or sale of all or
substantially all of the assets of the assigning Party to which the
subject matter of this Agreement relates, provided that the
assignee assumes all of the assigning Party’s obligations
under this Agreement. The terms and conditions of this Agreement
shall be binding upon and inure to the benefit of the permitted
successors and assigns of the Parties.
15.3
Counterparts. This Agreement may be executed simultaneously in
one or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the
same instrument.
15.4
Covenants and
Agreements. All covenants and
agreements of the Parties are subject to all applicable statutes of
limitation, statutes of repose, and other similar defenses provided
by law or equity.
15.5
Entire
Agreement. This is the entire
Agreement, including all exhibits and schedules hereto, between the
Parties with respect to the subject matter hereof and supersedes
all prior representations, understanding and agreements between the
Parties with respect to the subject matter
hereof. This Agreement supersedes the Mutual Confidential
Disclosure Agreement between the Parties dated as of February 23,
2018 (the “CDA”). All confidential information
exchanged
-36-
between the Parties under the CDA shall be deemed
Confidential Information and shall be subject to the terms of
Article 9. No amendments, modifications, or supplements of this
Agreement or any of the other Transaction Documents shall be valid
or effective unless in writing and executed by duly authorized
representatives of the Parties thereto.
15.6
Schedules; Exhibits. All Schedules and Exhibits referred to in this
Agreement are hereby incorporated herein and made a part of this
Agreement. The fact that any document, asset, item, action, entity,
event, condition, claim, agreement, or other matter (collectively
“Matters”) is set forth or described or referred to in
any one or more Schedule or Exhibit will not be construed as a
representation, warranty, acknowledgement, or admission by any
Party or as evidence that such Matter is, or may at any time be, or
have been, material or in any way significant to the transactions
contemplated by this Agreement.
15.7
Force
Majeure. Neither Party shall be
liable for failure of or delay in performing obligations
set forth in this Agreement, nor shall
be deemed in breach of its obligations to the extent such failure
or delay is caused by or results from causes beyond the reasonable
control of the affected Party, including but not limited to fire,
flood, embargo, war, acts of war (whether war is declared or not),
acts of terrorism, insurrection, riot, civil commotion, acts of
God, or intervening acts, omissions or delays perpetrated by
governmental authority; provided however, that the Party failing or
delayed shall use all reasonable efforts to avoid or remove such causes of failure
or delay, and shall continue to perform hereunder with reasonable
dispatch whenever such causes are removed. Either Party shall
promptly provide the other Party with written notice of any failure
or delay to perform believed to be attributable to force
majeure.
15.8
Survival. Expiration
or termination of this Agreement for
any reason shall not relieve a Party from obligations and
duties which (i) by their nature extend beyond the
expiration or termination of this Agreement and (ii) that are expressly indicated to survive
the termination or expiration
of this Agreement. Without limiting the foregoing, the following
provisions shall expressly survive any such expiration or
termination: Articles [***] and Sections [***]
15.9
Further
Assurances. Each Party agrees
to execute, acknowledge and deliver such further instructions, and
to do all such other acts, as may be necessary or appropriate to
carry out the purposes and intent of this
Agreement.
15.10
Governing Law. This Agreement shall be construed, interpreted
and applied in accordance with the laws of the State New York,
excluding its choice of law and conflict of law
provisions.
15.11
Language. This Agreement has been prepared in the language
of English and such language
shall control its interpretation.
15.12
Notice. Any notices, requests, consent, and
Invoices given under this Agreement shall be in writing and shall
be deemed given (i) upon
the date of personal delivery or by facsimile transmission (receipt
verified), provided that such date is a Business Day and if
confirmed by delivery of the hardcopy original by overnight courier
or registered mail; or (ii)
[***] Business Day after dispatch by overnight courier; or
(iii) [***] Business Days
after dispatch of registered or certified mail (return receipt
requested), postage prepaid, in each of subsection (i), (ii) or (iii), above, to the Parties at the
following addresses (or at such other address for a Party as shall
be specified by like notice, provided, however, that notices of a
change of address shall be effective only upon receipt
thereof):
If to
MABVAX:
11535
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇
-▇▇-
▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇
[***]
With a copy to:
[***]
If to
BI:
Boehringer
Ingelheim International GmbH
[***]
Fax:
[***]
With a copy to:
[***]
15.13
Relationship of the
Parties. Nothing in this
Agreement is intended or shall be deemed to constitute a partner,
agency, employer-employee, or joint venture relationship between
the Parties. Except as expressly provided in this Agreement,
neither Party shall be deemed as authorized or empowered to act on
behalf of the other Party, nor to bind or commit the other Party in
any manner whatsoever, including but not limited to incurring
expenses, liabilities or obligations.
15.14
Severability.
If any provision of this Agreement is or becomes invalid, is
declared illegal by a court of
competent jurisdiction or is deemed unenforceable under then
Applicable Law during the Term, it is the intention of the Parties
that the remainder of this Agreement shall not be affected thereby,
provided that a Party’s rights under this Agreement are not
materially affected negatively. The Parties agree to renegotiate
any such provision or the application thereof in good faith in
order to provide a reasonably acceptable alternative to the
provision or application thereof that is invalid, illegal, or
unenforceable, it being the intent of the Parties that the basic
purposes of this Agreement are to be
effectuated.
15.15
Time for Taking
Action. Whenever periods of
time are referred to in this Agreement in days, calendar days are
intended unless stated otherwise. When the day or last day for
taking any action is not indicated by a specific date, but is
instead stated as, e.g. “[***] days after…”, and
the day or last day falls on a day other than a Business Day, then
the action may be timely taken on the next Business Day without
prejudice to the Party taking action.
15.16
Use of
Name. Neither Party shall
employ or use the name, trademarks and logo of the other Party in
any promotional materials or advertising without obtaining the
prior, express written consent of the other
Party.
15.17
Waiver. The terms and conditions of the Transaction
Documents may be waived only by a written instrument executed by
duly authorized representatives of the Party waiving compliance.
The failure of either Party at any time to require performance of
any provision hereof shall in no manner affect its rights at a
later time to enforce the same. No waiver by either Party of any
condition or term shall be deemed as a continuing waiver of such
condition or term or as a waiver of another condition or
term.
[Remainder of the Page Intentionally Left Blank]
-38-
IN WITNESS WHEREOF, THE PARTIES CAUSE THIS AGREEMENT TO BE EXECUTED
BY THEIR DULY AUTHORIZED REPRESENTATIVES:
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MabVax Therapeutics Holdings,
Inc.:
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MabVax Therapeutics,
Inc.:
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By:__________________________________________
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By:
_________________________________________
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Name:
_______________________________________
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Name:
______________________________________
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Title:
________________________________________
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Title:
________________________________________
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Date:
________________________________________
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Date:
________________________________________
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Boehringer Ingelheim International
GmbH:
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Boehringer Ingelheim International
GmbH:
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ppa
By:__________________________________________
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ppa
By:
_________________________________________
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Name: [***]
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Name: [***]
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(Authorized Signatory) |
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Title: (Authorized
Signatory)
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Date: July 04,
2018
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Date: July 04,
2018
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Exhibits
Exhibit
A:
Form of Assignment
and Assumption Agreement
Exhibit
B:
Form of ▇▇▇▇ of
Sale
Exhibit
C:
[***] Program
Patent Assignment
Exhibit
D:
Press
Release
Schedules:
Schedule 1.1.26:
Executive
Officials
Schedule 1.1.37:
Invoice
Requirements
Schedule 1.1.63:
[***] Program
Patents
Schedule 7.1.2:
Finder’s
Fee
-39-
Exhibit A
Assignment and Assumption Agreement
ASSIGNMENT AND ASSUMPTION AGREEMENT
This ASSIGNMENT AND ASSUMPTION AGREEMENT
(this “Assignment
Agreement”) is made as of July 5, 2018, by and between
MabVax Therapeutics Holdings,
Inc., a corporation organized and existing under the laws of
Delaware, USA, having its principal place of business at ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
MabVax Therapeutics, Inc., a
corporation organized and existing under the laws of Delaware, USA,
having its principal place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, (MabVax Therapeutics
Holdings, Inc., and MabVax Therapeutics, Inc. collectively referred
to as “Seller”) and Boehringer Ingelheim International
GmbH, having a
principal place of business at ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇, (“Buyer”).
WHEREAS, Seller and Buyer entered into
that certain Asset Purchase and License Agreement, dated as of July
4, 2018 (the “Asset
Purchase and License Agreement”); and
WHEREAS, pursuant to the Asset Purchase and License
Agreement, Seller has agreed to sell, convey, transfer, assign and
deliver to Buyer all of Seller’s right, title and interest
in, to and under the Acquired Assets, and Buyer has agreed to assume, timely perform and
discharge in accordance with their respective terms, the Assumed
Liabilities.
NOW THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, and intending to be legally bound hereby, it is
hereby agreed that:
1. Definitions. Unless otherwise
defined herein, all capitalized terms used in this Assignment
Agreement shall have the meanings set forth in the Asset Purchase
and License Agreement.
2. Assignment of Acquired Assets.
Effective as of the Closing Date, Seller hereby sells, conveys,
transfers, assigns and delivers to Buyer all of Seller’s
right, title and interest in, to and under the Acquired Assets free
and clear of Encumbrances, and Buyer hereby accepts such sale,
conveyance, transfer, assignment and delivery from Seller;
provided, however, that the
tangible Acquired Assets are being specifically assigned and
transferred pursuant to the ▇▇▇▇ of Sale and any other Acquired
Assets that are specifically assigned or transferred pursuant to
any other Transaction Document are being specifically assigned and
transferred pursuant to such other Transaction Documents and, in
each case, shall not be assigned or transferred pursuant to this
Section
2.
3. Assumption of Assumed
Liabilities. Effective as of the Closing Date, Buyer hereby
assumes, accepts and agrees to timely perform and discharge in
accordance with their respective terms any and all of the Assumed
Liabilities; provided,
however, that any Assumed Liabilities that are specifically
assumed by Buyer pursuant to any other Transaction Document shall
not be assumed pursuant to this Section 3.
4. Subject to the Asset Purchase and
License Agreement. This Assignment Agreement is subject in
all respects to the terms and conditions of the Asset Purchase and
License Agreement, and all of the representations, warranties,
covenants and agreements of the Seller and Buyer contained therein,
all of which shall survive the execution and delivery of this
Assignment Agreement in accordance with the terms of the Asset
Purchase and License Agreement. Nothing in this Assignment
Agreement shall supersede, amend, alter or modify (nor shall it be
deemed or construed to supersede, amend, alter or modify) any of
the terms or conditions of the Asset Purchase and License Agreement
in any manner whatsoever. In the event of any conflict between the
provisions of this Assignment Agreement and the provisions of the
Asset Purchase and License Agreement, the provisions of the Asset
Purchase and License Agreement shall control and
prevail.
5. Representations and Warranties.
Except as set forth in the Asset Purchase and License Agreement,
the Seller makes no representations or warranties, express or
implied, with respect to the Acquired Assets or the Assumed
Liabilities, and the Seller expressly disclaims any implied
warranties.
6. Successors and Assigns. Except
as otherwise set forth in Section 15.2 of the Asset Purchase and
License Agreement, no assignment of this Assignment Agreement or of
any rights or obligations hereunder may be made by Seller or Buyer,
directly or indirectly (by operation of law or otherwise), without
the prior written consent of the other party hereto and any
attempted assignment without the required consents shall be null
and void and without any legal effect This Assignment Agreement
shall be binding upon and inure to the benefit of the parties and
their respective permitted successors and assigns.
7. Counterparts. This Assignment
Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
8. Amendments; Waiver. This
Assignment Agreement may be amended, supplemented or modified in
whole or in part if, but only if, such amendment, supplement or
modification is in writing and is signed by each party and specific
reference to this Assignment Agreement is made. Any provision of
this Assignment Agreement may be waived if, but only if, such
waiver is in writing and is signed by the party or parties against
whom enforcement of any such waiver is sought and specific
reference to this Assignment Agreement is made. The waiver by any
party hereto of a breach of any provision of this Assignment
Agreement shall not operate or be construed as a further or
continuing waiver of such breach or as a waiver of any other or
subsequent breach. No failure on the part of any party to exercise,
and no delay in exercising, any right, power or remedy hereunder
shall operate as a waiver thereof, nor shall any single or partial
exercise of such right, power or remedy by such party preclude any
other or further exercise thereof or the exercise of any other
right, power or remedy.
9. Severability. If any provision
of this Assignment Agreement is held invalid or unenforceable by
any court of competent jurisdiction, the other provisions of this
Assignment Agreement shall remain in full force and effect. The
parties further agree that if any provision contained herein is, to
any extent, held invalid or unenforceable in any respect under the
Applicable Laws governing this Assignment Agreement, they shall
take any actions necessary to render the remaining provisions of
this Assignment Agreement valid and enforceable to the fullest
extent permitted by Applicable Law and, to the extent necessary,
shall amend or otherwise modify this Assignment Agreement to
replace any provision contained herein that is held invalid or
unenforceable with a valid and enforceable provision giving effect
to the intent of the parties to the greatest extent legally
permissible.
10. Governing Law; Jurisdiction.
This Agreement shall be construed, interpreted and applied in
accordance with the laws of the State New York, excluding its
choice of law and conflict of law provisions.
SIGNATURE PAGES FOLLOW
IN WITNESS WHEREOF, the parties hereto
have caused this Assignment Agreement to be executed by their
respective officers thereunto duly authorized as of the date first
above written.
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Seller:
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By:
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Name:
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Title:
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Date:
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MabVax
Therapeutics, Inc.
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By:
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Name:
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Title:
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Date:
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-40-
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Buyer:
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Boehringer Ingelheim International GmbH
ppa.
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By:
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Name:
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Title:
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(Authorized
Signatory)
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Date:
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Boehringer Ingelheim International GmbH
ppa.
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By:
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Name:
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Title:
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(Authorized
Signatory)
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Date:
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[Signature Page Exhibit A to Asset Purchase and License Agreement
between MabVax Therapeutics Holdings Inc., MabVax Therapeutics
Inc., and Boehringer Ingelheim International GmbH, dated July 4,
2018]
-41-
Exhibit B
▇▇▇▇ of Sale
▇▇▇▇ OF SALE
This ▇▇▇▇ OF SALE (this
“▇▇▇▇ of
Sale”) is made as of July 5, 2018, by and between
MabVax Therapeutics Holdings,
Inc., a corporation organized and existing under the laws of
Delaware, USA, having its principal place of business at ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
MabVax Therapeutics, Inc., a
corporation organized and existing under the laws of Delaware, USA,
having its principal place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, (MabVax Therapeutics
Holdings, Inc., and MabVax Therapeutics, Inc. collectively referred
to as “Seller”) and Boehringer
Ingelheim International GmbH, having a principal place of business
at ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇,
(“Buyer”).
WHEREAS, Seller and Buyer entered into
that certain Asset Purchase and License Agreement, dated as of July
4, 2018 (the “Asset
Purchase and License Agreement”); and
WHEREAS, pursuant to the Asset Purchase
and License Agreement, Seller has agreed to sell, convey, transfer,
assign and deliver to Buyer all of the Acquired Assets, and Buyer
has agreed to purchase the Acquired Assets from
Seller.
NOW THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, and intending to be legally bound hereby, it is
hereby agreed that:
1. Definitions. Unless otherwise
defined herein, all capitalized terms used in this ▇▇▇▇ of Sale
shall have the meanings set forth in the Asset Purchase and License
Agreement.
2. Transfer of Assets. Effective
as of the Closing Date, Seller hereby sells, conveys, transfers,
assigns and delivers to Buyer all of Seller’s right, title
and interest in, to and under the tangible Acquired Assets free and
clear of Encumbrances, and Buyer hereby purchases such tangible
Acquired Assets and accepts such conveyance, transfer, assignment
and delivery; provided,
however, that any Acquired Assets that are specifically
assigned or transferred pursuant to any other Transaction Document
shall not be assigned or transferred pursuant to this Section 2.
3. Subject to the Asset Purchase and
License Agreement. This ▇▇▇▇ of Sale is subject in all
respects to the terms and conditions of the Asset Purchase and
License Agreement, and all of the representations, warranties,
covenants and agreements of the Seller and Buyer contained therein,
all of which shall survive the execution and delivery of this ▇▇▇▇
of Sale in accordance with the terms of the Asset Purchase and
License Agreement. The Acquired Assets are being delivered for good
and valuable consideration, pursuant to the terms and conditions
contained in the Asset Purchase and License Agreement. Nothing
contained herein shall supersede, amend, alter or modify (nor shall
it be deemed or construed to supersede, amend, alter or modify) any
of the terms or conditions of the Asset Purchase and License
Agreement in any manner whatsoever. In the event of any conflict
between the provisions of this ▇▇▇▇ of Sale and the provisions of
the Asset Purchase and License Agreement, the provisions of the
Asset Purchase and License Agreement shall control and
prevail.
4. Representations
and Warranties. Except as set forth in the Asset Purchase
and License Agreement, Seller makes no representations or
warranties, express or implied, with respect to the Acquired
Assets, and Seller expressly disclaims any implied
warranties.
5. Successors and Assigns. Except
as otherwise set forth in Section 15.2 of the Asset Purchase and
License Agreement, no assignment of this ▇▇▇▇ of Sale or of any
rights or obligations hereunder may be made by Seller or Buyer,
directly or indirectly (by operation of law or otherwise), without
the prior written consent of the other party hereto and any
attempted assignment without the required consents shall be null
and void and without any legal effect This ▇▇▇▇ of Sale shall be
binding upon and inure to the benefit of the parties and their
respective permitted successors and assigns.
6. Counterparts. This ▇▇▇▇ of Sale
may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one
and the same instrument.
7. Amendments; Waiver. This ▇▇▇▇
of Sale may be amended, supplemented or modified in whole or in
part if, but only if, such amendment, supplement or modification is
in writing and is signed by each party and specific reference to
this ▇▇▇▇ of Sale is made. Any provision of this ▇▇▇▇ of Sale may
be waived if, but only if, such waiver is in writing and is signed
by the party or parties against whom enforcement of any such waiver
is sought and specific reference to this ▇▇▇▇ of Sale is made. The
waiver by any party hereto of a breach of any provision of this
▇▇▇▇ of Sale shall not operate or be construed as a further or
continuing waiver of such breach or as a waiver of any other or
subsequent breach. No failure on the part of any party to exercise,
and no delay in exercising, any right, power or remedy hereunder
shall operate as a waiver thereof, nor shall any single or partial
exercise of such right, power or remedy by such party preclude any
other or further exercise thereof or the exercise of any other
right, power or remedy.
8. Severability. If any provision
of this ▇▇▇▇ of Sale is held invalid or unenforceable by any court
of competent jurisdiction, the other provisions of this ▇▇▇▇ of
Sale shall remain in full force and effect. The parties further
agree that if any provision contained herein is, to any extent,
held invalid or unenforceable in any respect under the Applicable
Laws governing this ▇▇▇▇ of Sale, they shall take any actions
necessary to render the remaining provisions of this ▇▇▇▇ of Sale
valid and enforceable to the fullest extent permitted by Applicable
Law and, to the extent necessary, shall amend or otherwise modify
this ▇▇▇▇ of Sale to replace any provision contained herein that is
held invalid or unenforceable with a valid and enforceable
provision giving effect to the intent of the parties to the
greatest extent legally permissible.
9. Governing Law; Jurisdiction.
This Agreement shall be construed, interpreted and applied in
accordance with the laws of the State New York, excluding its
choice of law and conflict of law provisions.
SIGNATURE PAGES FOLLOW
-42-
STRICTLY
CONFIDENTIAL
IN WITNESS WHEREOF, the parties hereto
have caused this ▇▇▇▇ of Sale to be executed by their respective
officers thereunto duly authorized as of the date first above
written.
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Seller:
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By:
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Title:
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Date:
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MabVax
Therapeutics, Inc.
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By:
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Name:
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-43-
STRICTLY
CONFIDENTIAL
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Buyer:
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Boehringer Ingelheim International GmbH
ppa.
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By:
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Name:
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Title:
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(Authorized
Signatory)
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Date:
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Boehringer Ingelheim International GmbH
ppa.
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By:
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Name:
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Title:
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(Authorized
Signatory)
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Date:
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[Signature Page Exhibit B to Asset Purchase and License Agreement
between MabVax Therapeutics Holdings Inc., MabVax Therapeutics
Inc., and Boehringer Ingelheim International GmbH, dated July 4,
2018]
-44-
STRICTLY CONFIDENTIAL
Exhibit C
[***] Program Patent Assignment
Pursuant
to the Asset Purchase and License Agreement by and between
Boehringer Ingelheim International
GmbH, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
(“BII”),
MabVax Therapeutics Holdings,
Inc., a corporation organized
and existing under the laws of Delaware, USA, having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, MabVax
Therapeutics Inc., a corporation organized and existing
under the laws of Delaware, USA, having its principal place of
business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (MabVax
Therapeutics Holdings, Inc. and MabVax Therapeutics Inc.
collectively referred to as “MABVAX”), and regarding
MABVAX´s assets relating to the [***] Program, effective July
4, 2018 (the “Agreement”), for good and valuable
consideration to them paid by BII, invoiced as of this Closing
Date, MABVAX hereby assigns as of the Closing Date to BII the full
and entire property, right and title in the [***] Program Patents
listed in Schedule 1.1.63 of the Agreement free and clear of
Encumbrances, a copy of which is attached hereto for reference, so
that BII may enjoy the full benefits and all the rights resulting
therefrom without restriction.
Subject
to the Agreement, MABVAX hereby authorizes BII to take any and all
actions in connection with the Patents, in BII´s own name and
at BII´s sole expense.
MABVAX Therapeutics Holdings, Inc.
By:
_____________________________
Name:
_____________________________
Title:
_____________________________
Date:
_____________________________
MABVAX Therapeutics, Inc.
By:
_____________________________
Name:
_____________________________
Title:
_____________________________
Date:
_____________________________
-45-
Boehringer Ingelheim International GmbH
ppa.
By:
_____________________________
Name:
Title:
(Authorized
Signatory)
Date:
Boehringer Ingelheim International GmbH
ppa.
By:
_____________________________
Name:
Title:
(Authorized
Signatory)
Date:
[Signature Page Exhibit C to Asset Purchase and License Agreement
between MabVax Therapeutics Holdings Inc., MabVax Therapeutics
Inc., and Boehringer Ingelheim International GmbH, dated July 4,
2018]
-46-
Exhibit D
Press Release
MabVax Therapeutics and Boehringer Ingelheim Sign Asset Purchase
and License Agreement and Related Agreements for an Antibody
Development Program Targeting Multiple Solid Tumor
Cancers
SAN
DIEGO, CA – July
9, 2018 – MabVax
Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage
oncology drug development company and Boehringer Ingelheim today
announced they have signed an asset acquisition and related
agreements centered on MabVax’s program targeting a glycan
commonly overexpressed on multiple solid tumor cancers. Boehringer
Ingelheim has acquired all
rights in and to the program.
MabVax
will receive a total of US $11 million in upfront and near term
milestones as well as downstream regulatory milestone payments plus
further earn-out payments. The asset acquisition is separate and
distinct from other programs under development at MabVax, enabling
MabVax to retain all rights to its lead HuMab-5B1antibody program
which is in Phase 1 clinical trials as a therapeutic product and as
a diagnostic product, as well as other antibody discovery programs
from the Company’s rich antibody discovery portfolio
targeting other cancer antigens.
MabVax
discovered the antibody series at the center of this transaction
from biological samples, originally from patients who were
vaccinated against their solid tumors with a glycan
antigen-containing vaccine. The discovery of fully human antibodies
directly from vaccinated cancer patients has potential advantages
which include greater specificity and reduced toxicities. MabVax
completed and has reported on early preclinical development
activities to establish the utility of the program.
“We
are very pleased to have Boehringer Ingelheim as a major industry
partner to further develop one of our preclinical antibody assets
based on our proprietary HuMab technology,” said ▇▇▇▇▇
▇▇▇▇▇▇, President and CEO of MabVax Therapeutics. “This agreement with Boehringer
Ingelheim recognizes the value of our innovative approach to
discovering novel antibodies to diagnose and treat cancer.
We have been committed since the founding of the Company to
discovering and developing unique fully human antibodies to
diagnose and treat patients with cancers where there remain
significant unmet medical needs.”
About MabVax:
MabVax Therapeutics Holdings, Inc. is a clinical-stage
biotechnology company with a fully human antibody discovery
platform focused on the rapid translation into clinical development
of products to address unmet medical needs in the treatment of
cancer. Our antibody MVT-5873, is a fully human IgG1 monoclonal
antibody (mAb) that targets sialyl ▇▇▇▇▇ A (sLea), an epitope on
CA19-9, and is currently in Phase 1 clinical trials as a
therapeutic agent for patients with pancreatic cancer and other
CA19-9 positive tumors. CA19-9 is expressed in over 90% of
pancreatic cancers and in other diseases including small cell lung
and GI cancers. CA19-9 plays an important role in tumor adhesion
and metastasis, and is a marker of an aggressive cancer phenotype.
CA19-9 serum levels are considered a valuable adjunct in the
diagnosis, prognosis and treatment monitoring of pancreatic cancer.
With our collaborators including Memorial Sloan Kettering Cancer
Center, ▇▇▇▇▇ ▇▇▇▇▇▇ Research Institute, Honor Health and Imaging
Endpoints, we have treated over 56 patients with either our
therapeutic antibody designated as MVT-5873 or our PET imaging
diagnostic product designated as MVT-2163 in Phase 1 clinical
studies, and demonstrated early safety and specificity for the
target. Patient dosing is continuing in Phase 1 clinical studies of
MVT-5873 in combination with nab-paclitaxel and gemcitabine to
patients newly diagnosed with CA19-9 positive pancreatic cancer,
and for the Company's radioimmunotherapy product MVT-1075. Other
discovery programs at MabVax are in preclinical development. For
additional information, please visit the Company's website,
▇▇▇.▇▇▇▇▇▇.▇▇▇.
Forward Looking Statements
This
press release contains “forward-looking statements”
regarding matters that are not historical facts, including
statements relating to the asset acquisition and related agreements
centered on the undisclosed program, and what programs remain at
MabVax that continue to be under development in the Company’s
development pipeline. We have no assurance that all of the product
development pipeline will be fully developed by the Company.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Words such as
"anticipates," "plans," "expects," "intends," "will," "potential,"
“hope” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon current expectations of the Company and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties. Detailed
information regarding factors that may cause actual results to
differ materially from the results expressed or implied by
statements in this press release relating to the Company may be
found in the Company’s periodic filings with the Securities
and Exchange Commission, including the factors described in the
section entitled “Risk Factors” in its annual report on
Form 10-K for the fiscal year ended December 31, 2017, as amended
and supplemented from time to time and the Company's Quarter Reports on Form
10-Q and other filings submitted by the Company to the SEC, copies
of which may be obtained from the SEC's website at
▇▇▇.▇▇▇.▇▇▇. The parties do not undertake
any obligation to update forward-looking statements contained in
this press release.
Investor Contact:
Email: ▇▇▇▇▇▇▇▇@▇▇▇▇▇▇.▇▇▇
Media Contact:
▇▇▇▇▇
Partners LLC
Phone:
▇▇▇-▇▇▇-▇▇▇▇
Email:
▇▇▇▇▇▇.▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇
-47-
Schedule 1.1.26
Executive Official
1.
For MABVAX:
[***]
2.
For BII:
[***]
-48-
Schedule
1.1.37
Invoice Requirements
Invoices
to be sent to:
Boehringer
Ingelheim International GmbH
[***]
The
invoice must be in accordance to the actual Tax Law.
-49-
Schedule 1.1.63
[***] Program Patents
|
COUNTRY
|
SERIAL NO.
|
Attorney Docket NO.
|
ASSIGNEE
|
INVENTORS
|
PRIORITY FILING DATE
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
-50-
Schedule 7.1.2
Finder’s Fee
[***]
-51-
Schedule 11.4
S[***] Agreement
AGREEMENT
by and between
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
and
[***]
and
MABVAX THERAPEUTICS HOLDINGS, INC.
and
MABVAX THERAPEUTICS, INC.
BII Contract No:[***]
-52-
This Agreement (the “Agreement”) is made on July 4, 2018 (the
“Effective
Date”) under the terms
and conditions herein by and between Boehringer Ingelheim
International GmbH having a
principal place of business at ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇, (hereinafter referred to as “BII[***] MabVax Therapeutics Holdings,
Inc., a corporation organized
and existing under the laws of Delaware, USA, having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, and MabVax Therapeutics,
Inc., a corporation organized
and existing under the laws of Delaware, USA, having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, (MabVax Therapeutics Holdings, Inc. and
MabVax Therapeutics, Inc. hereinafter collectively referred to as
“MabVax”). BII, [***] and MabVax are
referred to individually as a "Party" and collectively as the
"Parties."
WHEREAS, BII and MabVax have entered into an Asset Purchase
and License Agreement on July 4, 2018 (the “BII/MabVax
Agreement”), attached hereto in Appendix 1.
WHEREAS, under the BII/MabVax Agreement, MabVax sells,
conveys, assigns and transfers to BII, and BII acquires from
MabVax, certain of MabVax’s assets solely and exclusively
related to MabVax’s [***] Program, as further defined in the
BII/MabVax Agreement as Acquired Assets.
WHEREAS, MabVax Therapeutics Inc. and [***] have entered into [***] agreement dated [***] (the “[***] Agreement”).
[***]
NOW, THEREFORE, the Parties
hereby agree as follows:
1.
MabVax agrees and acknowledges that during the
term of the [***] Agreement, as amended, MabVax shall
continue to be responsible for all of its obligations therein,
including but not limited to any and all payment obligations due by
MabVax to [***]
(“[***]
Payments”).
2.
BII agrees that in the event that the [***]
Agreement expires or is terminated for any reason, including but
not limited to bankruptcy or liquidation of MabVax and subject to
Section 3 below, BII’s obligations to MabVax Therapeutics
Holdings Inc. under the following Sections of the BII/MabVax
Agreement shall be
[***]:
a.
Section
5.3: All Milestone Payments (as
defined in the BII/MabVax Agreement) which would otherwise have been owed to
MabVax Therapeutics Holdings Inc., had the [***] Agreement not been
terminated, shall be paid directly to [***] in accordance with
Sections 5.3 of the BII/MabVax Agreement;
b.
Section
5.4: All Earn-Out
Payments (as defined in
the BII/MabVax Agreement) which
would otherwise have been owed to MabVax Therapeutics Holdings
Inc., had the [***] Agreement not been terminated, shall be paid
directly to [***] in accordance with Section 5.4 of the BII/MabVax Agreement during the term of the Earn-Out Period (as defined
in the BII/MabVax Agreement).
c.
Section
5.4.5: BII shall provide [***]
with the written reports as described in Section 5.4.5 of
the BII/MabVax Agreement.
d.
Sections 5.5 –
5.9: All payment obligations
from BII to [***] in subsections (a) and (b) hereinabove shall be
made in accordance with Sections 5.5-5.9 of the BII/MabVax
Agreement.
3.
Notwithstanding anything to the contrary, BII,
[***] and MabVax agree that the payments by BII to [***] under
Section 2 above shall not be due if such payment (i) is prohibited
by Applicable Law, including without limitation insolvency law,
(ii) has already been made to MabVax Therapeutics Holdings Inc. in
accordance with the BII/MabVax Agreement, and/or (iii) will have to be made to
MabVax Therapeutics Holdings Inc. in accordance with Applicable
Law, it being understood that in case of (i) or (iii) BII shall
make the payments due under the BII/MabVax Agreement to MabVax Therapeutics Holdings Inc., or
a trustee, if applicable, in accordance with the terms and
conditions of the BII/MabVax Agreement and Applicable Law.
4.
For avoidance of doubt, [***] is not party to
the BII/MabVax Agreement and
shall have no liabilities to BII.
5.
[***]
agrees that [***] will not assert against BII, its Affiliates,
Sublicensees or its or their distributors or independent
contractors any claims for infringement of those [***] Rights
[***], based on the research, development, manufacture, use, sale,
offer for sale or license, or import of any BII Product [***], so
long as BII pays the Milestone Payments and the Earn-Out Payments
in accordance with the above Section 2.
6.
This Agreement shall be construed, interpreted and applied in
accordance with the laws of the State New York, excluding its
choice of law and conflict of law provisions. Any dispute which has
not been resolved amicably by BII, MabVax and [***], as applicable,
shall be escalated to the applicable executive official level
employee of each BII, [***], and/or MabVax. Said employees shall
use further good faith efforts to reach resolution on such dispute
within [***] days.
7.
If
BII, MabVax and/or [***], as applicable do not reach resolution on
such dispute within such [***] days period, then BII, MabVax and/or
[***], as applicable, agree to first try, in good faith, to settle
the dispute by mediation, administered by the American Arbitration
Association (the “AAA”) under its Commercial Mediation
Procedures, before resorting to the arbitration procedure set forth
in Section 8 below. BII, MabVax and/or [***], as applicable, may
initiate mediation upon written notice to the other party(ies) and
the AAA ("Mediation Notice Date"), whereupon the respective parties
shall be obligated to engage in a mediation proceeding. The
mediation shall commence within [***] days of the Mediation Notice
Date. The mediation shall be conducted by a single mediator in New
York, New York. The party requesting mediation shall designate two
(2) or more nominees for mediator in its notice. The other
party(ies) may accept one of the nominees or may designate its own
nominees by notice addressed to the AAA and to the requesting
party. If within [***] days following the Mediation Notice Date,
the parties to the dispute have not selected a mutually acceptable
mediator, a mediator shall be appointed by the AAA according to the
Commercial Mediation Rules. The mediator shall attempt to
facilitate a negotiated settlement of the dispute, but shall have
no authority to impose any settlement terms on the parties to the
dispute. The expenses of the mediation shall be borne equally by
the parties to such mediation, but each party shall be responsible
for its own counsel fees and expenses. BII, MabVax and [***]
acknowledge that the existence, content, or results of a dispute
under such mediation shall not be disclosed without the prior
written consent of BII, MabVax, and/[***], as
applicable.
8.
Any dispute which has not been resolved by the
procedures set forth in Sections 6 or 7 above shall be finally
resolved by binding arbitration in accordance with the ICC
arbitration rules by three (3) arbitrators. Place of such arbitration shall be New York, New
York. The language of the arbitration proceeding shall be English.
Except to the extent necessary to confirm or obtain judgment on an
award or decision or as may be required by Applicable Law, neither
BII, MabVax and/or [***], as applicable, may, and BII, MabVax
and/or [***] shall instruct the arbitrators not to, disclose the
existence, content, or results of a dispute without the prior
written consent of the parties to such
arbitration.
9.
[***]. No
disclosure of the existence, and/or the terms, of this Agreement
may be made by either Party, and no Party shall use the name,
trademark, trade name or logo of the other Party, its affiliates or
their respective employees in any publicity, promotion, news
release or disclosure relating to this Agreement or its subject
matter, without the prior express written permission of the other
Party, except as may be required by applicable law or securities
exchange regulations.
10.
This is the entire
Agreement, including all exhibits and schedules hereto, between the
Parties with respect to the subject matter hereof and supersedes
all prior representations, understanding and agreements between the
Parties with respect to the subject matter hereof.
11.
If any provision of
this Agreement is or becomes invalid, is declared illegal by a
court of competent jurisdiction or is deemed unenforceable under
then applicable law during the Term, it is the intention of the
parties that the remainder of this Agreement shall not be affected
thereby, provided that a party’s rights under this Agreement
are not materially affected negatively. The Parties agree to
renegotiate any such provision or the application thereof in good
faith in order to provide a reasonably acceptable alternative to
the provision or application thereof that is invalid, illegal, or
unenforceable, it being the intent of the parties that the basic
purposes of this Agreement are to be effectuated.
12.
This Agreement may
be executed simultaneously in one or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
[Remainder of the Page Intentionally Left Blank]
-53-
IN WITNESS WHEREOF, THE PARTIES CAUSE THIS AGREEMENT TO BE EXECUTED
BY THEIR DULY AUTHORIZED REPRESENTATIVES:
Ingelheim,__________________________
(date)
Boehringer Ingelheim International GmbH
ppa.
ppa.
_______________________
_______________________
Name:
Name:
Authorized
Signatory
Authorized Signatory
Date:
__________________
Date: __________________
|
[Place],__________________________
(date)
MabVax Therapeutics Holdings Inc.
_______________________
Name:
Authorized
Signatory
[Place],__________________________
(date)
MabVax Therapeutics Inc.
_______________________
Name:
Authorized
Signatory
|
[Place],
______________________
(date)
[***]
_______________________
Name:
Authorized
Signatory
|
-54-
Appendix 1
Asset Purchase and License Agreement
-55-