***Text Omitted and Filed
Separately
Confidential Treatment
Requested
Under 17 C.F.R. §§
200.80(b)(4), and 240.24b-2
OPTION, COLLABORATION AND LICENSE
AGREEMENT
This Option, Collaboration and License
Agreement (the “ Agreement ”) is made and
entered into effective as of January 12, 2009 (the “
Effective Date ”), by and between Micromet AG , having its
principal place of business at Staffelseestrasse 2, 81477 Munich,
Germany (“ Micromet ”), and Bayer Schering Pharma AG ,
having its principal place of business at Muellerstrasse 178, 13353
Berlin, Germany (“ Bayer
”). Micromet and Bayer each may be referred to
herein individually as a “ Party ,” or
collectively as the “ Parties .”
Recitals
A. Micromet
has developed a proprietary platform for discovery, research, and
development of BiTE ® antibodies, which may have applications in the
treatment of cancer and other diseases.
B.
Bayer
is a pharmaceutical company with experience in the development and
commercialization of pharmaceutical products.
C. Micromet
desires to grant, and Bayer desires to receive an option to
collaborate with Micromet on the research and parts of the
development of products comprising BiTE antibodies binding to a
specific target in accordance with the terms described
below.
D. Upon
exercise of the option rights provided hereunder, the Parties will
collaborate on the development of such products, with Bayer being
responsible for the further development and commercialization of
such products on a worldwide basis.
In consideration of the foregoing premises and
the mutual promises and covenants contained herein and other good
and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties hereby agree as
follows:
Agreement
When used in
this Agreement, capitalized terms will have the meanings as defined
below and throughout the Agreement.
1.1 “
Affiliate ” means a legal entity that, directly or
indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with a
Party. For purposes of this definition only,
“control” and, with correlative meanings, the terms
“controlled by” and “under common control
with” means (a) the possession, directly or indirectly, of
the power to direct the management or policies of a legal entity,
whether through the ownership of voting securities or by contract
relating to voting rights or corporate governance, or (b) the
ownership, directly or indirectly, of more than 50% of the voting
securities or other ownership interest of a legal
entity.
1.2 [***]
has the meaning as defined in Section 4.6.5.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.3 “
Applicable Law ” means the laws, rules, and
regulations, including any statutes, rules, regulations,
guidelines, or other requirements that may be in effect from time
to time and apply to the development, manufacture, registration,
and marketing of the Product in the countries of the Territory,
including any such statutes, rules, regulations, guidelines, or
other requirements of the FDA or the EMEA.
1.4 “
[***] ” means any Third Party performing an activity
pursuant to the [***] on the basis of a contractual arrangement
with Bayer.
1.5 [***]
means any Patents or Know-How generated by employees or agents of a
[***] in the course of, in furtherance of, and as a direct result
of such employees or agents performing an activity pursuant to the
[***] that (i) are [***], (ii) [***] of [***] or [***] of [***],
and (iii) [***.]
1.6 [***]
has the meaning as defined in Section 7.3.1.
1.7 “
[***] Development Plan ” means the description of the
development activities for the Product under the [***] from the
date of the plan.
1.8 “
[ *** ] Technology ” means any Patent or
Know-How (i) owned or Controlled by [***] or its Affiliates as of
the Effective Date; or (ii) independently discovered or reduced to
practice after the Effective Date by [***] or its Affiliates in
performing activities other than the [***] or [***] conducted
pursuant to this Agreement.
1.9 “
[***] ” means the development program conducted by or
on behalf of [***] or any of [***] under this Agreement for the
Product [***] for such Product.
1.10 “
[ *** ] ” means any Patents or Know-How that
(i) [***] that perform activities pursuant to the [***] conducted
under this Agreement in the course of, in furtherance of, and as a
direct result of such employees, agents or independent contractors
performing an activity pursuant to the [***]; (ii) [***]of [***] or
[***] of [***]; and (iii) are [***] [***] [***] [***] [***] [***]
[***;] provided that the foregoing will not include (a) any [***]
Technology; and (b) any [***] by [***] of [***] of the [***] in the
course of, in furtherance of, and as a direct result of such
employees, agents or independent contractors performing an activity
[***].
1.11 “
BiTE Antibody ” means any bi-specific, single-chain
antibody binding via [ *** ] to T cells.
1.12 “
BLA ” means a Biologics License Application,
supplemental Biologics License Application, or similar application
to be filed with the FDA, and any equivalent applications in
jurisdictions outside the United States of America, including a
marketing approval application for submission to the
EMEA.
1.13 “
Business Day ” means any day that is not a public
holiday in the Federal Republic of Germany, the State of Berlin, or
the State of Bavaria.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.14 “
Change of Control ” means with respect to any entity
(the “ Acquired Entity ”) (a) any sale,
exchange, transfer, or issuance to or acquisition by one or more
Third Parties of shares representing more than fifty percent (50%)
of the aggregate ordinary voting power entitled to vote for the
election of directors represented by the issued and outstanding
stock of the Acquired Entity or any Affiliate that directly or
indirectly controls the Acquired Entity (whether by sale or merger,
but excluding the issuance of shares in financing transactions),
whether such sale, exchange, transfer, issuance or acquisition is
made directly or indirectly, beneficially or of record or in one
transaction or a series of related transactions; (ii) a merger or
consolidation under applicable law of the Acquired Entity with a
Third Party in which the shareholders of the Acquired Entity or any
Affiliate that directly or indirectly controls the Acquired Entity
immediately prior to such merger or consolidation do not continue
to hold immediately following the closing of such merger or
consolidation at least fifty percent (50%) of the aggregate
ordinary voting power entitled to vote for the election of
directors represented by the issued and outstanding stock of the
entity surviving or resulting from such consolidation; or (iii) a
sale or other disposition of all or substantially all of the assets
of the Acquired Entity to one (1) or more Third Parties in one
transaction or a series of related transactions.
1.15 “
Collaboration Target ” means the whole or part of
[***] (“[***]”) identified by the [***] entry name
[***] and [***] and all of [***].
1.16 “
Collaboration Program ” means the [***] conducted
pursuant to this Agreement with respect to the Collaboration
Target.
1.17 “
[***] ” means (i) any invention that is conceived, and
any Know-How that is generated solely or jointly by employees,
agents or independent contractors of either or both Parties in the
course of, in furtherance of, and as a direct result of such
employees, agents or independent contractors performing an activity
pursuant to the [***], and (ii) any Patent to the extent claiming
such invention or Know-How.
1.18 “
Commercialization ” means the manufacture, marketing,
promotion, advertising, selling and distribution of the Product in
a country after all required Marketing Approvals have been obtained
in such country. The term “ Commercialize
” has a correlative meaning.
1.19 “
Commercially Reasonable Efforts ” means the level of
efforts consistent with the reasonable practices of (i) in the case
of Bayer: a company in the prescription pharmaceutical
industry comparable in size and operations to Bayer, or (ii) in the
case of Micromet: a company in the discovery, research and
development of antibodies, determined, in each case, based upon
conditions then prevailing, [***] provided, however, that
Commercially Reasonable Efforts requires that the Party in
accordance with its standard practices [***].
1.20 “
Control ” and, with correlative meaning, the term
“ Controlled ”, means, with respect to a Party
and any Patent, Know-How, or other intellectual property right, the
ability to grant the other Party access, a license, a sublicense or
the right to use (as applicable) such Patent, Know-How, or
intellectual property right as provided in this Agreement without
violating the terms of any license granted by, or agreement or
other arrangement with, any Third Party.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.21 “
D2 Decision ” means the decision by Bayer whether or
not to continue the development of a Product following the review
of the data and information as further described in Exhibit
A .
1.22 “
D3 Decision ” means the decision by Bayer whether or
not to continue the development of a Product following the review
of the data and information as further described in Exhibit
A .
1.23 “
Development Expenses ” means all costs and expenses
incurred by a Party in carrying out any activities to be performed
pursuant to the [***] Development Plan, calculated in accordance
with U.S. generally accepted accounting principles (or IFRS, if and
when enacted in the U.S.) consistently applied and such
Party’s cost accounting systems, provided that the cost of a
Party’s FTEs performing such activities will be calculated at
the FTE Rate.
1.24 “
EMEA ” means the European Medicines Agency, or any
successor agency thereto.
1.25 “
Executive Officer ” means (a) in the case of [***],
the [***] of [***]; and (b) in the case of [***], the
[***].
1.26 “
FDA ” means the United States Food and Drug
Administration, or any successor agency thereto.
1.27 “
Field ” means the treatment of diseases and conditions
in humans or animals.
1.28 “
First Commercial Sale ” means the date on which Bayer
or an Affiliate or a licensee of Bayer first sells commercially for
use or consumption by the public, following receipt of all
Marketing Approvals necessary to commence regular commercial sales,
a Product to a Third Party. A sale of a Product by Bayer to an
Affiliate or licensee will not constitute a First Commercial
Sale. Sales prior to receipt of all Marketing Approvals
necessary to commence regular commercial sales in a particular
country that are made in furtherance of obtaining Marketing
Approval in such country, such as so-called “treatment IND
sales,” “named patient sales” and
“compassionate use sales,” will not be construed as a
First Commercial Sale.
1.29 “
FTE ” means the equivalent of a total of [***] hours
per year of scientific or technical work on or directly related to
the execution or implementation of the [***] Development Plan, or
other tasks to be performed under this Agreement, carried out by a
qualified employee or consultant of a Party. Scientific
or technical work may include, but is not limited to, research,
experimental laboratory work, developing manufacturing processes
for the Product, conducting pre-clinical and clinical development
of the Product, recording and writing up results, reviewing
literature and references, holding scientific discussions, and
attending conferences in the relevant field.
1.30 “
FTE Rate ” means €[***] per FTE, which amounts
include, for each FTE, [***] and [***] (excluding items provided
for separately under the applicable Development Plan), [***] and a
[***] plus [***].
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.31 “
IND ” means any clinical trial application, including
any Investigational New Drug Application filed or to be filed with
the FDA, and any equivalent application in jurisdictions outside
the United States of America, including Investigational Medicinal
Product Dossier filed or to be filed with the EMEA.
1.32 “
Indication ” means a tumor of an organ or any discrete
form or precursor condition of a tumor or treatment thereof for
which a BLA may be filed.
1.33 [***]
has the meaning as defined in Section 7.3.1.
1.34 “
[***] Development Plan ” means the plan and
budget for the research and development of the Product during the
[***], as may be amended in accordance with Section 4.3.
1.35 “[***
] ” means the research and development program of the
Product conducted [***] up to and including [***] that have been
initiated prior to the [***] for the Product.
1.36 “
JPT ” has the meaning as defined in Section
3.6.1.
1.37 “
JSC ” has the meaning as defined in Section
3.1.
1.38 “
Know-How ” means (a) any scientific or technical
information, results and data of any type whatsoever, in any
tangible or intangible form whatsoever, that is not in the public
domain or otherwise publicly known, including databases, practices,
methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures, and
manufacturing process and development information, results and
data, and (b) any biological, chemical, or physical materials that
are not in the public domain or otherwise available to the public;
all to the extent not claimed or disclosed in a Patent.
1.39
“License Effective Date” has the meaning as
defined in Section 2.3.
1.40 “
Licensed Technology ” means the Micromet Technology
and Sublicensed Technology.
1.41 “
Major Market ” means each of the [***], the [***],
[***], [***], [***], [***] and [***].
1.42 “
Marketing Approval ” means with respect to a
regulatory jurisdiction, any and all approvals, [***] of any
federal, state or local regulatory agency, department, bureau or
other governmental entity, necessary for [***], Commercialization
or sale of a Product in such regulatory jurisdiction, including,
where applicable, (a) [***] in such regulatory jurisdiction, (b)
[***] (including any prerequisite manufacturing approval or
authorization related thereto), (c) [***] approval and (d) [***]
and [***].
1.43 [***]
means any Third Party engaged in the research, development or
Commercialization of BiTE Antibodies on the basis of a license
under the Micromet Technology or any other contractual arrangement
with Micromet relating to the Micromet Technology.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.44
“[ *** ]” means any Patents or Know-How
of a [***] that (i) are [***] (ii) [***] and (iii)
[***].
1.45 “
[ *** ] Technology ” means (i) [***] generated
solely by [ *** ] Affiliates’ employees or by a
Third Party on Micromet’s behalf; and (ii) any Patent or
Know-How generated by an employee or independent contractor of
[***] during the [***] conducting research and development
activities on BiTE Antibodies binding to the Collaboration Target,
excluding the [ *** ] Patent or any Know-How
comprising inventions claimed therein.
1.46 “
[ *** ] ” means any Patents or Know-How
licensed or acquired by Micromet from a Third Party other than a
[***] that (i) [***], and (ii) [***].
1.47 “
Micromet Product ” means any product consisting
of or containing a BiTE Antibody binding to a target other than the
Collaboration Target.
1.48 “
Micromet Technology ” means (i) the Patents listed on
Exhibit C and any Know-How necessary or useful for the
development and Commercialization of the Product in the Field, each
to the extent Controlled by Micromet as of the Effective Date; and
(ii) any [***] [***] and [***] with respect to which the Parties
have executed an amendment to this Agreement pursuant to Section
7.4.2.
1.49
[ *** ] ” means any Patents or Know-How, other
than [***], that (i) [***] (ii) [***] and (iii) [***].
1.50 “
Net Sales ” means the amount invoiced
by Bayer, its Affiliates or sublicensees for sales of
the Product to unaffiliated Third Parties less the following
deductions applicable to the Product determined in accordance with
U.S. GAAP or IFRS and with Bayer’s, or its Affiliate’s
or sublicensee’s standard methods as generally and
consistently applied:
(a) transportation
charges, distribution, packing and handling charges, and insurance
charges to the extent included in the invoice price;
(b) sales
and excise taxes or customs duties or any other governmental
charges imposed upon the sale of the Product (other than taxes
based on income), to the extent included in the invoice
price;
(c) sales
performance bonuses paid to distributors, and rebates and premiums
granted or allowed in connection with the sale of a
Product;
(d) allowances
or credits to customers on account of governmental requirements,
price differences arising in connection with sales in countries
where the price is fixed in local currency, but payments are made
in another currency, rejection, outdating, returns or recalls of
the Product;
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
(e) quantity
discounts, cash discounts or chargebacks granted in connection with
the sale of the Product;
(f) provisions
for retroactive price reductions;
(g) costs
of customer programs agreed upon by the Parties in writing such as
cost effectiveness or patient assistance studies or programs
designed to aid in patient compliance with medication schedules in
connection with the sale of a Product;
Sales between the Parties, or between the
Parties and their Affiliates or sublicensees, for resale will be
disregarded for purposes of calculating Net Sales. The
Parties recognize that (a) Bayer’s customers may include
persons in the chain of commerce who enter into agreements with
Bayer as to price even though title to the Product does not pass
directly from Bayer to such customers and even though payment for
such Product is not made by such customers directly to Bayer and
(b) in such cases, chargebacks paid by Bayer to or through a third
party (such as a wholesaler) can be deducted by Bayer pursuant to
subsection (e) above. Any deductions above which involve a payment
by Bayer will be taken as a deduction against aggregate sales for
the period in which the payment or deduction is made. Any of the
items set forth above that would otherwise be deducted from the
invoice price in the calculation of Net Sales but which are
separately charged to, and paid by, Third Parties will not be
deducted from the invoice price in the calculation of Net Sales. In
the case of any sale of a Product for consideration other than
cash, such as barter or countertrade, Net Sales will be calculated
on the fair market value of the consideration received as agreed by
the Parties. If any discounts or other similar deductions are
granted or allowed in connection with sales of the
Product together with other products of Bayer, its Affiliates or
sublicensees, the discounts or deductions will be allocated to
Products and such other products on a pro rata basis based on the
respective list prices of the Product and such other
products.
In the event a Product is sold in the form of a
combination product containing one or more active ingredients in
addition to a Product, Net Sales for such combination product will
be adjusted by multiplying actual Net Sales of such combination
product by the fraction A / (A+B) where A is the invoice price of
the Product, if sold separately, and B is the invoice price of any
other active ingredient or ingredients in the combination, if sold
separately. If, on a country-by-country basis, the other active
ingredient or ingredients in the combination are not sold
separately in that country, Net Sales will be calculated by
multiplying actual Net Sales of such combination product by the
fraction A / C where A is the invoice price of the Product if sold
separately, and C is the invoice price of the combination product.
If, on a country-by-country basis, neither the Product nor the
other active component or components of the combination product is
sold separately in said country, Net Sales will be determined
between the Parties in good faith.
1.51 “
Patents ” means (a) all patents and patent
applications in any country or supranational jurisdiction, and (b)
any provisionals, substitutions, divisions, continuations,
continuations in part, reissues, renewals, registrations,
confirmations, reexaminations, extensions, supplementary protection
certificates and the like, of any such patents or patent
applications.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.52 “
Phase 1 Trial ” means a clinical trial of a
pharmaceutical product on healthy subjects or patients with the
primary purpose of determining safety, metabolism and
pharmacokinetic properties and clinical pharmacology of such
product, as more fully defined in 21 C.F.R. § 312.21(a), or
its successor regulation, or the equivalent in any foreign country,
including any clinical trial that is a combination Phase 1 Trial
and Phase 2 Trial.
1.53 “
Phase 2 Trial ” means a clinical trial in human
patient population to determine the safe and effective dose range
in the proposed therapeutic indication, as more fully defined in 21
C.F.R. § 312.21(b), or its successor regulation, or the
equivalent in any foreign country.
1.54 “
Phase 3 Trial ” means a clinical trial in human
patients designed to (a) establish that a drug is safe and
efficacious for its intended use; (b) define warnings, precautions
and adverse reactions that are associated with the drug in the
dosage range to be prescribed; and (c) support BLA Approval of such
drug, as more fully defined in 21 C.F.R. § 312.21(c), or its
successor regulation, or the equivalent in any foreign
country.
1.55 “
Pivotal Trial ” means (a) Phase 3 Trial or (b) a Phase
2 Trial that is of appropriate size and design to establish that a
pharmaceutical product is safe and effective for its intended use,
to define warnings, precautions and adverse reactions that are
associated with the pharmaceutical product in the dosage range to
be prescribed, and to support a BLA for such pharmaceutical product
or label expansion of such pharmaceutical product. For clarity, the
determination of whether a Phase 2 Trial is a Pivotal Trial for
purposes of this Agreement will be based upon a determination by
the relevant Regulatory Authority that such trial could be
sufficient, depending on its outcome, to support the filing of a
BLA for such pharmaceutical product or label expansion of such
pharmaceutical product.
1.56 “
Positive D2 Decision ” means a D2 Decision to continue
a [***].
1.57 “
Positive D3 Decision ” means a D3 Decision to continue
a [***].
1.58 “
Product ” means any product containing or comprising a
BiTE Antibody binding to the Collaboration Target developed
pursuant to this Agreement, including all forms, presentations,
doses and formulations thereof alone or in combination with other
therapeutically active ingredients; it being understood that all
pharmaceutical products that contain the same BiTE Antibody will be
considered the same Product.
1.59 “
Project Team Leader ” has the meaning as defined in
Section 3.6.2.
1.60 [***
] Patent ” means the patent application filed on [***]
under the no. [***] on the BiTE Antibody directed against [***] and
any Patents arising therefrom.
1.61 “
Regulatory Authority ” means any national (e.g., the
FDA), supra-national (e.g., the European Commission, the Council of
the European Union, or the European Medicines Agency), regional,
state or local regulatory agency, department, bureau, commission,
council or other governmental entity in each country of the world
involved in the granting of Marketing Approval for the
Product.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
1.62 “
Regulatory Submission ” means any submission or
application made or filed with a Regulatory Authority, including
any IND or BLA.
1.63 “
Sublicensed Technology ” means any Patent or Know-How
Controlled by Micromet pursuant to the Agreements listed in
Exhibit D-1 and Exhibit D-2 .
1.64 “
Territory ” means all countries of the world,
[***].
1.65 “
Third Party ” means any entity other than Micromet,
Bayer or their respective Affiliates.
1.66 “
Valid Claim ” means (a) an issued claim of an issued
patent that has not (i) expired or been canceled, (ii) been
declared invalid by a decision of a court or other appropriate body
of competent jurisdiction, from which no appeal is or can be taken,
(iii) been admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise, or (iv) been abandoned or disclaimed; and
(b) a claim included in a pending patent application that is being
actively prosecuted and that has not been (i) canceled, (ii)
withdrawn from consideration, (iii) finally determined to be
unallowable by the applicable governmental authority (from which no
appeal is or can be taken), or (iv) abandoned or disclaimed,
provided, however, that if a claim of a patent application
has been pending for more than [***] years, such claim will not
constitute a Valid Claim for the purposes of this Agreement unless
and until a Patent issues with such claim.
2.1
Option Grant. Micromet hereby grants Bayer an
exclusive option (the “ Option ”) during the
Option Period (defined below) to license the Licensed Technology
for the development and Commercialization of the Product and to
collaborate with Micromet regarding such development and
Commercialization of such Product on the terms set forth in this
Agreement.
2.2
Option Fee. Bayer will pay to Micromet a
non-refundable, non-creditable option fee of €4,500,000 in
accordance with the terms of Section 9.1 within thirty (30) days
after the Effective Date.
2.3
Option Exercise. Bayer may exercise the Option
at any time during a period commencing on the Effective Date and
ending at midnight (Central European Time) of January 5, 2010
(the “ Option Period ”) by providing Micromet
with written notice (“ Option Exercise Notice ”)
of Bayer’s desire to exercise the Option and making a payment
to Micromet in the amount of € [ *** ] (the
“ Option Exercise Fee ”). Bayer will notify
Micromet, on a non-binding basis, of its intent regarding the
exercise of the Option not later than ninety (90) days prior to the
expiration of the Option Period. Promptly after receipt
of such declaration of intent, Micromet will provide to Bayer a
schedule listing the exceptions, if any, to the representations and
warranties made by Micromet in Section 15.2 or provide a written
confirmation that there are none. Micromet will continuously
provide updates to such schedule or confirmation whenever there is
a change until one (1) Business Day after receipt of the Option
Exercise Notice where Micromet will provide a final schedule or
confirmation. If such final schedule or confirmation deviates from
the last schedule or confirmation received from Micromet prior to
dispatch of the Option Exercise Notice, Bayer may withdraw the
Option Exercise Notice by providing written notice to Micromet
within ten (10) Business Days from receipt of the final schedule or
confirmation. Upon receipt by Micromet of the Option Exercise
Notice and the Option Exercise Fee (the “ License
Effective Date ”) prior to the expiration of the Option
Period, Bayer will be granted the rights in this Agreement and all
of the terms and conditions of this Agreement will be binding on
the Parties, unless it withdraws its Option Exercise Notice in
accordance with this Section 2.3.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
2.4
Exclusivity. During the Option Period, Micromet
will not (i) negotiate, offer, enter into, or otherwise discuss
with any Third Party any agreement granting any option or license
with respect to the Licensed Technology for the Collaboration
Target; or (ii) collaborate or provide services to a Third Party
with respect to the Micromet Technology for the Collaboration
Target or otherwise grant rights that would prevent, upon the
exercise of the Option, the grant of the rights, licenses, and
interests to Bayer under the terms and conditions of this
Agreement.
2.5
Updates. During the Option Period,
Micromet will provide Bayer with a quarterly update regarding its
activities in respect of the BiTE Antibody binding to the
Collaboration Target. Micromet will provide such update by
telephone conference or a meeting, if the Parties agree, to
designated representatives of Bayer. In addition, Micromet will
provide a written report on the status and the results of such
activities by September 30, 2009 and will thereafter, upon request
of Bayer, provide Bayer the opportunity to review and discuss with
Micromet any data and results generated during the Option
Period.
2.6
Binding Effect. Prior to the License Effective
Date, (a) only the following Sections are legally binding on the
Parties: 1, 2, 4.5.1, 4.6.1, 7.8.2, 7.8.3, 9.1, 10, 11, 12, 13.4,
15, 16 and 17, and (b) the foregoing terms (other than Section 10,
13.4, 15, 16 and 17) will terminate and be of no further force and
effect upon the earlier of (i) termination of this Agreement by
Bayer pursuant to Section 12.3.1 or (ii) expiration of the Option
Period without exercise of the Option in accordance with Section
2.3.
3.1
Establishment of Joint Steering Committee.
Promptly after the License Effective Date, the Parties will
establish a joint steering committee (the “ JSC
”) to oversee the [***]. Each Party will appoint
three employees to serve as their representatives on the JSC. From
time to time, on written notice to the other Party, Micromet and
Bayer each may substitute any of its representatives on the JSC
unable to attend a meeting or replace a representative by a new
one. Each Party will designate one of its members of the JSC as the
“Co-Chair.” Subject to the provisions of this Section
3, the JSC will establish its own procedural rules for its
operation.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
3.2
Tasks of the JSC. The JSC will: (a) review and
approve any updates or amendments to the [***] Development Plan,
including, subject to Section 4.3, any changes to the budget for
the [***]; (b) monitor the progress of and coordinate the
activities undertaken pursuant to the [***] Development Plan; (c)
decide on the achievement of scientific or technical objectives and
any go/no go criteria as described in the [***] Development Plan;
(d) discuss and consider which Party files and prosecutes Patents
for an invention within the [***] in accordance with the provisions
of Section 7.8.1; (e) resolve any issues that could not be resolved
by the JPT; (f) propose and consider amendments to the terms of
this Agreement, provided that any such amendment will be made by
the Parties solely pursuant to Section 17.6; and (g) take such
other actions as are expressly delegated to the JSC in this
Agreement. The JSC will not have any power to amend this
Agreement and will have only such powers as are specifically
delegated to it under this Agreement.
3.3
JSC Meetings. The JSC will meet not less than
once every calendar quarter during the first year after the License
Effective Date, and not less than once every six months thereafter.
Meetings may be held in person or by means of telecommunication
(telephone, video, or web conferences); provided that at least two
meetings during the first year after the License Effective Date and
one meeting per year thereafter will be held in person. The JSC may
meet more frequently by agreement of the Parties or at the
reasonable request of a Party with not less than twenty (20)
Business Days notice to the other. The Co-Chairs will
alternately be responsible for organizing the meetings of the JSC
and for distributing the agenda of the meetings. The
Co-Chairs will include on the agenda any item within the scope of
the responsibility of the JSC that is requested to be included by a
Party, and will distribute the agenda to the Parties no less than
one week before any meeting of the JSC. Each Party may,
with the prior approval of the other Party which will not be
unreasonably withheld, invite non-voting employees, consultants or
advisors (which consultants and advisors will be under an
obligation of confidentiality no less stringent than the terms set
forth in Section 10) to attend any meeting of the
JSC. Each Party will bear its own costs associated with
holding and attending JSC meetings.
3.4
Meeting Minutes. The Co-Chair (or its designee)
responsible for the organization of the respective JSC meeting will
prepare the minutes, and send it to all members of the JSC for
review and approval within twenty (20) days after the
meeting. Each Party will send any objections against the
accuracy or completeness of such minutes by providing written
notice to the other members of the JSC within fourteen (14) days of
receipt of the minutes. In the event of any such
objection that is not resolved by mutual agreement of the Parties,
such minutes will be amended to reflect such unresolved
dispute.
3.5.1 The
JSC will take action on matters within its power by unanimous
consent of the Parties, with each Party having a single vote,
irrespective of the number of representatives actually in
attendance at a meeting, or by a written resolution signed by its
representatives.
3.5.2 If
the JSC is unable to reach unanimous consent on a particular
matter, such matter will be resolved in a second JSC meeting to be
held within twenty (20) Business Days from the meeting in which the
disputed matter has remained unresolved. In the event that the JSC
is again unable to resolve the matter, either Party may provide
written notice of such dispute to the Executive Officer of the
other Party. The Executive Officers (or their respective
designees, who must be members of the Party’s senior
management, but who are not members of the JSC) of each Party will
meet at least once in person to discuss the dispute and use their
good faith efforts to resolve the JSC dispute within thirty (30)
days after submission of such dispute to such officers. If the
Executive Officers (or their designees) cannot reach agreement with
respect to a JSC dispute within the thirty (30) day time period,
[***].
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
3.5.3 Notwithstanding
the terms of Section 3.5.2 above, if the matter concerns a dispute
regarding the interpretation of this Agreement, the performance or
alleged nonperformance of a Party’s obligations under this
Agreement, or any other alleged breach of this Agreement, such
matter will be resolved in accordance with the terms of Section
17.4.
3.6.1 Promptly
after the License Effective Date, the Parties will establish a
joint project team (the “ JPT ”) for managing
the day-to-day work within the [***], consisting of an appropriate
number of representatives of each Party. In particular,
the JPT will have the following tasks: (a) developing and proposing
any updates or amendments to the [***] Development Plan; (b)
coordinating the activities undertaken pursuant to the [***]
Development Plan, including assigning specific development tasks to
the appropriate Party consistent with the terms of Section 4; (c)
ensuring timely performance of the activities under the [***]
Development Plan; (d) monitoring the expenses of the [***] and
compliance with the budget in the [***] Development Plan; (e)
making proposals on achievement of scientific or technical
objectives and go/no go criteria pursuant to the [***] Development
Plan; (f) making proposals on which Party files and prosecutes
Patents for an invention within the [***] in accordance with the
provisions of Section 7.8.1; (g) supporting each Party’s
Patent filings within the [***]; and (h) preparing update reports
for the Product and presenting such updates at the JSC
meetings.
3.6.2 Each
Party will designate one of its JPT members as the project team
leader (the “ Project Team Leader ”) who will be
the primary contact person for the other Party for matters relating
to the development of the Product by such Party. In
order to ensure regular information of the JSC on the progress with
respect to the [***], the Project Team Leaders will be permanent
guests of the JSC.
3.6.3 The
JPT will meet not less than once a quarter. Meetings may be held in
person or by means of telecommunication (telephone, video, or web
conferences). The JPT may meet more frequently by
agreement of the Parties or at the reasonable request of a Party
with not less than twenty (20) Business Days notice to the
other. The Project Team Leaders will alternately be
responsible for organizing the meetings of the JPT and for
distributing the agenda of the meetings. The Project
Team Leaders will include on the agenda any item within the scope
of the responsibility of the JPT that is requested to be included
by a Party, and will distribute the agenda to the Parties no less
than one week before any meeting of the JPT. Each Party
may, with the prior approval of the other Party which will not be
unreasonably withheld, invite non-voting employees, consultants or
advisors (which consultants and advisors will be under an
obligation of confidentiality no less stringent than the terms set
forth in Section 10) to attend any meeting of the
JPT. Each Party will bear its own costs associated with
holding and attending JPT meetings.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
3.6.4 The
Project Team Leader (or his or her designee) responsible for the
organization of the respective JPT meeting will prepare the
minutes, and send it to all members of the JPT for review and
approval within twenty (20) days after the meeting. Each
Party will send any objections against the accuracy or completeness
of such minutes by providing written notice to the other members of
the JPT within fourteen (14) days of receipt of the
minutes. In the event of any such objection that is not
resolved by mutual agreement of the Parties, such minutes will be
amended to reflect such unresolved dispute.
3.6.5 The
JPT will take action by unanimous consent of the Parties, with each
Party having a single vote, irrespective of the number of
representatives actually in attendance at a meeting, or by a
written resolution signed by the designated representatives of each
Party. If the JPT is unable to reach unanimous consent
on a particular matter, such matter will be submitted to the JSC
for resolution in accordance with Section 3.5. The JPT
will not have any power to amend this Agreement and will have only
such powers as are specifically delegated to it under this
Agreement.
3.7
[ *** ] of JSC and JPT. The JSC and the
JPT will be [***].
4.1
[***] Development Plan. The initial [***]
Development Plan is attached as Exhibit B
. Promptly following the License Effective Date, the
Parties will consider and discuss amendments to the initial [***]
Development Plan to reflect the anticipated activities, budgets and
timelines then applicable. The [***] Development Plan
and any amendments thereto will be designed to accomplish the
filing of INDs for the Product in one or more Major Markets, will
set specific objectives for carrying out development activities in
the course of the [***], will include a budget for such activities,
and will be reviewed and updated as necessary or appropriate by the
JPT and JSC in accordance with the provisions of Section
4.3.
4.2
Allocation of Responsibilities. As and to the
extent described in the [***] Development Plan, the Parties will be
responsible for the performance of the activities as
follows:
4.2.1 Micromet
will be responsible for research and preclinical development of the
Product up to the filing of the first IND for the applicable
Product, including any protein engineering, and in vitro and in
vivo pharmacology and laboratory studies within the toxicology
testing, except that Bayer will conduct certain preclinical studies
(e.g. imaging studies) as well as the in-life phase and
histopathologic evaluation of toxicology studies prior to the
filing of the first IND for such Product as further detailed in the
[***] Development Plan. Unless otherwise agreed by the
Parties, Micromet will generate BiTE Antibodies binding to the
Collaboration Target.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
4.2.2 Micromet
will be responsible for the development of a production cell line,
pre-formulation studies, bioanalytics and process development, and
the manufacturing of research-grade material, and Bayer will be
responsible for scale up, further process optimization and the
manufacturing, fill & finish of Product for GLP tox testing and
clinical trials.
4.2.3 The
Parties will collaborate on the Phase 1 Trials of the Product
conducted during the [***], with [***] holding the IND for the
Product and taking the lead in the performance of Phase 1 Trials
and associated regulatory activities, and [***] performing [***]
and participating in the [***] of such Phase 1 Trials (including
[***] and the review and assessment of [***] and participation in
the discussions with the meetings with the [***] and the [***] for
the various the clinical trials).
4.2.4 Bayer
will be fully responsible for the further development of the
Product after completion of [***] in accordance with
the [***] Development Plan, and the regulatory activities,
including BLA filings.
4.3
Revisions of the [***] Development Plan. The JPT
will periodically review and propose to the JSC updates of the
[***] Development Plan to reflect the progress achieved and the
further development activities to be undertaken by the Parties in
the development of the Product, but not less than once every year
in conjunction with the Parties’ budget and program review
cycle. Notwithstanding anything in this Agreement, any
of the following changes to a [***] Development Plan may be
implemented only by an amendment of this Agreement executed by two
duly authorized officers of Micromet and Bayer: (a) any reduction
or increase of any budget set forth in such [***] Development Plan
by more than [***]; (b) any reduction or increase of the aggregate
amount to be spent during the [***] or in a calendar year pursuant
to such [***] Development Plan by more than [***]; (c) any change
to the allocation of responsibilities between the Parties set forth
in Section 4.2 with respect to such [***] Development Plan; and (d)
the allocation of responsibility for any tasks unassigned in the
then-current [***] Development Plan. In addition, any revisions to
the [***] Development Plan must be approved by the JSC in
accordance with Section 3.2.
4.4
Development Expenses. Bayer will bear its own
Development Expenses and any Development Expenses incurred by
Micromet that have been budgeted in the [***] Development Plan, and
will pay such Development Expenses of Micromet as specified in
Section 8.1; provided, however, that Micromet
will not have any obligation to perform any activities under the
[***] for which it is not being reimbursed by Bayer, and
provided further, that Micromet will be reimbursed for
activities that have been either delayed or accelerated as required
by Bayer in an amended [***] Development Plan.
4.5 Diligence
in Development
4.5.1 Micromet
will use Commercially Reasonable Efforts to generate a BiTE
Antibody binding to the Collaboration Target, and to perform the
activities assigned to it in the [***] Development
Plan. All efforts of Micromet’s Affiliates will be
considered efforts of Micromet for the purpose of determining
Micromet’s compliance with its obligations under this Section
4.5.1.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
4.5.2 Bayer
will use Commercially Reasonable Efforts to perform the activities
assigned to it in the [***] Development Plan, to perform the [***]
Development Plan, and to develop and obtain Marketing Approval for
the Product in the Major Markets. All efforts of Bayer’s
Affiliates, contractors or sublicensees will be considered efforts
of Bayer for the purpose of determining Bayer’s compliance
with its obligations under this Section 4.5.2. If Bayer fails to
utilize such diligence and if such failure constitutes a material
breach of this Agreement, Micromet may terminate the Agreement in
accordance with and under the conditions specified in Section 12.2.
[***].
4.6.1
Micromet Records. All activities performed by or
on behalf of Micromet during the Option Period and under the [***]
Development Plan will be completely and accurately recorded in
written records, in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes. Such records will
be retained by Micromet for at least [***] after the termination of
this Agreement or for such longer period as may be required by any
Applicable Law.
4.6.2
Bayer Records. All activities performed by or on
behalf of Bayer in the course of the Collaboration Program
(including all Regulatory Submissions and activities and records
related to Bayer’s regulatory activities) will be completely
and accurately recorded in written records, in sufficient detail
and in good scientific manner appropriate for patent and regulatory
purposes. Such records will be retained by Bayer for at least [***]
after the termination of this Agreement or for such longer period
as may be required by any Applicable Law.
4.6.3
Inspection of Records. Each Party will have the right,
during normal business hours and upon reasonable notice, to inspect
and copy any such records, except that a Party may provide copies
with redactions of any information that either is not licensed to
the other Party or does not relate to the development, manufacture
or Commercialization of the Product.
4.6.4
Reports on [ *** ]. Each Party will
provide the JPT with regular oral or written reports detailing its
development activities under the [***] Development Plan and the
results of such activities.
4.6.5
[***] Development Plan; Reports on [ *** ].
Prior to the [***], Bayer will create and submit to
Micromet a copy of the initial [***]Development Plan for the [***],
which plan may be revised by Bayer from time- to-time. Bayer will
report to Micromet on the [***] (including a [***] and one or more
representatives of [***] The [***] will provide Micromet
in advance of [***] with a copy of the then-current [***]
Development Plan. Representatives of other relevant Bayer functions
may participate in the [***] In addition, Bayer will provide to
Micromet on [***] written progress reports with a summary of past
activities in the performance of the [***] and an updated [***]
Development Plan not later than [***] following the end of the
[***].
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
4.7
Subcontracting. Each Party may perform any of
its obligations under the Joint Development Plan through service
providers such as e.g. contract research organizations, consultants
or universities with the other Party’s prior written consent
which will not be unreasonably withheld. The Party using a service
provider will remain responsible to the other Party for the work
performed by the service provider. Each Party will ensure that such
service providers are bound in writing by obligations of
confidentiality and non-use regarding Confidential Information that
are substantially the same as those undertaken by the Parties
pursuant to Section 10 hereof, that the agreement with such service
providers contains customary terms providing for the assignment to
such Party (sufficient for a Party to grant to the other Party the
rights provided herein but subject to normal and customary retained
rights of university or government collaborators) of all results
developed in the course of performing the services for such Party
and that any publication of such results will be subject to the
other Party’s prior written consent.
4.8
Third Party Agreements . The JPT will monitor and
discuss during the JPT meetings the technologies, materials, and
processes used in or required for the development or
Commercialization of the Product. If either Party identifies any
such technology, material, or process that is not yet licensed by
either Party, then the Project Team Leader of such Party will bring
the matter to the attention of the JPT at the next JPT meeting, or,
if the JPT does no longer exist, of the other Party as soon as
reasonably practicable. The Party who will be responsible for
payments to the Third Party in accordance with Section 8.4 will
have the first right to negotiate and enter into an agreement with
respect to such technology, material or process, subject to the
terms and conditions of this Agreement (including, without
limitation, the allocation of costs described in Section 8.4). If
the respective Party [***] or if it fails to [***] within [***]
following the notice described above, then the other Party will
have the right to [***] in its discretion, [***] with respect to
such technology, material or process, subject to the terms and
conditions of this Agreement. In any case, the Party negotiating
such Third Party agreement will use reasonable efforts to secure a
license that is sublicensable to the other Party for the Product on
the same terms and conditions applicable to the negotiating
Party.
4.9
Follow-up Program. If the first Product candidate fails and
development of such Product is discontinued before [***], a new
[***] for a replacement Product candidate (a “ Replacement
Product ”) will be started at Bayer’s request,
which request will be made in writing within [ *** ]
after Bayer has decided to discontinue the development of the first
Product candidate, or Bayer will terminate this
Agreement by giving [ *** ] written notice
to Micromet within such period. Promptly following the receipt of
such request, the Parties will: (a) [ *** ], if they
have been [ *** ] pursuant to Section [ ***
]; (b) prepare a [***] Development Plan; and (c) conduct the
development and Commercialization of the Replacement Product in
accordance with the provisions of this Agreement.
|
|
Product Manufacture and
Commercialization
|
5.1
Commercial Manufacturing. Except as expressly
otherwise provided in the [***] Development Plan, Bayer will be
responsible for all commercial manufacturing activities related to
the Product, including without limitation, process development and
scale-up, further process optimization and the manufacturing, fill
& finish of Product for GLP toxicology testing, clinical trials
and commercial sale.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
5.2
Commercialization. Subject to Section 5.5, Bayer
will be solely responsible for the Commercialization of the Product
in the Territory during the Term.
5.3
Diligence in Commercialization. Bayer’s
diligence obligation during Commercialization will be [***] to
[***] in the Major Markets after having received Marketing Approval
for such countries; provided, however, where Bayer is
marketing the Product through a Third Party or sublicensee, such
Third Party or sublicensee will be obliged to [***] to
Commercialize the Product in the Major Markets. If Bayer fails to
comply with its obligation under this Section 5.3 and if such
failure constitutes a material breach of this Agreement, Micromet
may terminate the Agreement in accordance with and under the
conditions specified in Section 12.2. [***]
5.4
Branding, Trademarks, Trade Dress, and Logos.
Bayer will solely own, and will be solely responsible for
selecting, the trademark used to identify any Product that will be
Commercialized in the Territory pursuant to this
Agreement. Bayer will oversee the filing, prosecution
and maintenance of all trademark registrations for the Product in
the Territory, and Bayer will be responsible for the payment of any
and all costs relating to such filing, prosecution, and
maintenance. Bayer will have sole responsibility for,
and will be sole owner of, all trade dress, logos, slogans, and
designs used on and in connection with any Product that will be
Commercialized in the Territory pursuant to this
Agreement.
5.5
Right of First Negotiation for [ *** ].
If [***] desires to [***] a Product through one or more Third
Parties in any country, it will notify [***] and will offer to
[***] a right to [***] in such country. If [***] does
not notify [***] of its interest in [***] within [***] from receipt
of [***] notice or if the Parties have not [***], or such longer
period as the Parties may agree, [***] will be free to
[***].
6.1
Regulatory Submissions; Inspections . Bayer will
be responsible for the preparation, filing, prosecution and
maintenance of any Regulatory Submissions for the
Product. Bayer will promptly notify Micromet in writing
and, to the extent reasonably possible, in advance of any meeting
with or inspection by any Regulatory Authority relating to the
Product. Micromet will assist Bayer, as may be
reasonably necessary, in the preparation of Regulatory Submissions
and inspections by Regulatory Authorities, including providing
necessary documents or other materials required by Applicable Law,
and will, if requested by a Regulatory Authority, grant access to
its personnel and facilities to representatives of Bayer and the
Regulatory Authority, all at Bayer’s expense. With [***],
Micromet may [***] with and [***] by [***] as [***].
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
6.2
INDs; Regulatory Approvals; Adverse Drug Experiences.
[***] will be responsible for obtaining and maintaining
any [***] and [***] and other [***] for the Commercialization of
the Product in the Territory, including communicating and preparing
and filing all reports (including adverse drug experience reports)
with the applicable regulatory authorities, provided that [***]
will provide [***] with a reasonable opportunity to provide
comments to such portions of filings where data generated by [***]
are presented to the Regulatory Authorities. To the extent either
Party receives any information regarding relevant safety
information related to the use of the Product, such Party will
promptly provide the other Party with such information as is
required under Applicable Laws. Prior to the enrolment
of the first patient in a study related to a Product, the Parties
will agree on a standard operating procedures implementing the
requirements under Applicable Law for safety information exchange,
which procedures, as may be amended from time to time upon mutual
agreement of the Parties, will be incorporated in this Agreement by
reference.
6.3
Communications with Regulatory Authorities. [***
] will be solely responsible for any communications with the
regulatory authorities occurring or required in connection with
obtaining or maintaining any [ *** ] and [ ***
] for the Product. [ *** ] will provide
[ *** ] with [***] relating to the
Product, [***].
7.1 License
and Sublicense Grants by Micromet.
7.1.1
Micromet Technology and [***]. Subject to the
terms and conditions set forth in this Agreement, Micromet grants
to Bayer an exclusive, royalty-bearing license, under
the Micromet Technology (except for any Sublicensed Technology),
the [***] and Micromet’s interest in the [***], to
perform any activities assigned to Bayer in the [***] Development
Plan and to develop, have developed, make, have made, use, have
used, offer for sale, have offered for sale, sell, have sold,
import and have imported Product in the Field in the
Territory.
7.1.2
Sublicensed Technology. Subject to the terms and
conditions set forth in this Agreement, Micromet grants to Bayer an
exclusive, royalty-bearing sublicense, under the Sublicensed
Technology, to perform any activities assigned to Bayer in the
[***] Development Plan and to develop, have developed, make, have
made, use, have used, offer for sale, have offered for sale, sell,
have sold, import and have imported Product in the Field in the
Territory. Bayer acknowledges and agrees that the rights, licenses
and sublicenses granted by Micromet to Bayer in this Agreement are
subject to this Agreement and [ *** ] Bayer covenants
not to take or fail to take any action that violates [ ***
].
7.2 License
Grants by Bayer.
7.2.1
Bayer Technology. Subject to the terms and
conditions set forth in this Agreement, Bayer grants to Micromet a
non-exclusive, royalty-free license, under any applicable Patents
or Know-How Controlled by Bayer during the [***] of the [***]
(including the [***] and Bayer’s interest in the [***])
, for the sole purpose of conducting those development
responsibilities assigned to Micromet under the [***] Development
Plan. Such license will be sublicensable solely to
subcontractors approved by Bayer, such approval not be unreasonably
withheld.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
7.2.2
[ *** ] Technology. Subject to the terms
and conditions set forth in this Agreement, Bayer grants to
Micromet a worldwide, sole (i.e. exclusive except as to Bayer and
its Affiliates) royalty-free license under the [***] Technology to
develop, have developed, make, have made, use, have used, offer for
sale, have offered for sale, sell, have sold, import and have
imported Micromet Products in the Field. Sections [***],
[***] and [***] will apply to the license to Micromet mutatis
mutandis .
7.2.3
[ *** ]. Subject to the terms and
conditions set forth in this Agreement, Bayer grants to Micromet an
exclusive, worldwide, royalty-free license under [***] in the [***]
to develop, have developed, make, have made, use, have used, offer
for sale, have offered for sale, sell, have sold, import and have
imported Micromet Products in the Field. Sections [***], [***] and
[***] will apply to the license to Micromet mutatis mutandis
.
7.2.4
[ *** ]. Micromet will have the right to
[***], under the license granted under Section 7.2.2 and Section
7.2.3 only to [***] and only to those [***] that [***] the [***] of
[***] to [***] pursuant to this Agreement.
7.3.1
Ownership. Micromet will own all right, title and interest
in and to any [***] Technology. Bayer will own all right, title and
interest in and to any [***] generated solely by Bayer’s or
Bayer’s Affiliates’ employees or by a Third Party on
Bayer’s behalf (the [***]”). Any [***] generated [***]
by employees of [***] or their respective Affiliates will be [***]
by the Parties [***]”).
7.3.2
Disclosure of [ ***] . Each Party will
disclose to the other Party the development, making, conception or
reduction to practice of any [***] within [***], and will ensure
that such [***] is disclosed to it by its Affiliates and
contractors as necessary for such Party to comply with its own
obligations under this Section 7.3.2. The Parties will make such
disclosure to the [***] or the [***] in the course of the
performance of the [***]. If such [***] within [***] Technology or
[***] Technology, the owner thereof pursuant to Section 7.3.1 above
may withhold the disclosure to the other Party until after the
filing of a patent application claiming such invention.
7.4.1 Bayer
will have the right to request from time to time the disclosure of
[***], any [***] and any [***]. Upon receipt of such request,
Micromet undertakes to use reasonable efforts to provide Bayer a
summary of such [***], [***], and [***] in such detail as is
reasonably required for Bayer to determine its interest in [***] a
[***] thereunder pursuant to this Section 7.4. If Bayer
desires to use or apply any [***] or [***] within the [***], [***],
or [***] in the development or Commercialization of a Product,
Bayer will notify Micromet thereof in writing, and the Parties will
meet to discuss the extent to which such [***], [***], or [***]
would be necessary for the development or Commercialization of the
Product. If Bayer determines that such [***], [***] or
[***] would be necessary for the development or Commercialization
of the Product and [***], then Bayer will provide Micromet with
written notice of such determination, and the Parties will [***]
the [***] for [***] such [***], [***] or [***] in the licenses
granted to [***] under this Agreement (it being understood that
Bayer will be responsible for [***] on account of any [***] or
[***] to the extent arising from Bayer’s practice of [***] to
such [***] except as provided in Section 7.12.2 or Section 8.4.2).
If the Parties fail to [***], the procedure described in Section
[***] will apply.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
7.4.2 Upon
execution of a [***] identifying the [***], [***], or [***] and
reflecting the [***] by the [***] or established pursuant to
Section 17.4.3(a), such [***] [***] and [***] will be deemed [***]
and [***] under this Agreement; provided, however, that
[***] or [***] to Third Parties, if such Third Parties are [***]
that do not [***] of [***] to Micromet pursuant to this Agreement;
and provided further, that [***] under this Agreement to
[***] and [***] will be subject to any terms and conditions of
[***] under which Micromet receives [***] to such [***] and
[***].
7.5 [***];
[***]. Micromet will have the right to request from time
to time the disclosure of [***] and [***]. Upon receipt
of such request, Bayer undertakes to use reasonable efforts to
provide Micromet a summary of such [***] and [***] in such detail
as is reasonably required for Micromet to determine its interest in
[***] pursuant to this Section 7.5. If Micromet desires to use or
apply any [***] or [***] within the [***] or [***] in the
development or Commercialization of a Micromet Product, Micromet
will notify Bayer thereof in writing, and the Parties will meet to
discuss the extent to which such [***] or [***] would be necessary
for the development or Commercialization of a Micromet
Product. If Micromet determines that such [***] or [***]
would be necessary for the development or Commercialization of a
Micromet Product and [***], then Micromet will provide Bayer with
written notice of such determination, and the Parties will [***]
for the development and Commercialization of [***] (it being
understood that Micromet will be responsible for all payments due
to a Third Party on account of any [***] to any [***] to the extent
arising from Micromet’s practice of [***]; provided,
however, that such [***] will only be [***] by [***] to [***]
and only to those [***] that [***] of [***] to [***] pursuant to
this Agreement; provided further, that the license granted
under this Agreement to [***] will be subject to any terms and
conditions of the [***] under [***]; and provided further
that Sections [***] and [***] of this Agreement shall apply [***]
mutatis mutandis . If the Parties fail to [***] of
Micromet’s notice, the procedure described in Section [***]
will apply.
7.6
[***] by Bayer. Subject to the terms and
conditions of this Agreement, [***], Bayer will have the right
[***] to a Third Party the [***] through [***]; provided,
however, that (a) Bayer may not [***], on a
country-by-country basis in all or a portion of Europe or the
United States other than for purposes of [***] after [***], (b)
Bayer will [***] for the performance of Bayer’s obligations
under this Agreement (either directly by Bayer or by [***]), and
(c) Bayer provides to Micromet a [***] of such [***] that the
[***], and [***] of this Agreement. For clarity, the Parties agree
and acknowledge that [***] will be deemed to be the [***] for
purposes of this Agreement if such Third Party has [***] and that
Section 7.6 (a) shall not [***]
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
7.7
Reservation of Rights . Bayer hereby covenants
and agrees not to use or practice any Licensed Technology, nor
cause or authorize any Affiliate or Third Party to use or practice
any Licensed Technology, other than as expressly permitted in this
Agreement. Except for the rights specifically granted in
this Agreement, Micromet reserves all rights to the Licensed
Technology and reserves the right to utilize or allow Third Parties
to utilize the Licensed Technology consistent with the terms of
this Agreement. In addition, Micromet reserves all
rights in the Licensed Technology to the extent necessary for it to
conduct those development responsibilities assigned to it under the
[***] Development Plan. No implied licenses are granted
under this Agreement.
7.8 Filing,
Prosecution and Maintenance of Patents.
7.8.1 [***].
Micromet will have the first right
to file, prosecute, defend and maintain at its costs and in its
name any Patents claiming inventions or discoveries that are
[***] . Bayer will have the first right to file,
prosecute, defend and maintain at its costs and in its name any
Patents claiming inventions or discoveries that are [***]
Technology . With regard to inventions or
discoveries within the [***], the Parties will discuss on a
case-to-case basis who will file, prosecute, defend and maintain
Patents claiming such inventions or discoveries, based on the
Parties’ understanding that Micromet will bear such
responsibility with respect to Patents within [***]
more [***] to the [***] and that Bayer will bear such
responsibility with respect to Patents within [***] more [
***] to the [***]. Any such filing,
prosecution and maintenance will be made [***] , but at the
[***] costs. The filing Party will reasonably
inform the other Party and consult with the other Party and, to the
extent possible, will undertake the filing, prosecution and defense
of any Patents within [***] in a way that will not be
detrimental to the prosecution, issuance and validity of Patents
that are part of [***], or the development or
Commercialization of the Product. If the filing Party
does not want to continue the prosecution of a patent application
in the [***], it will inform the other Party thereof in
writing with sufficient advance notice to reasonably enable the
other Party to assume the filing or prosecution of such Patent at
its cost. If the other Party decides to assume the filing or
prosecution of such Patent, the filing Party will assign such
Patent to the other Party.
7.8.2 [***]
Patent. Micromet will have the right to
file, prosecute, defend and maintain at its costs the [***]
Patents. Micromet will reasonably inform Bayer and
consult with Bayer and will undertake the filing, prosecution and
defense of such Patents in a way that will not be detrimental to
the prosecution, issuance and validity of Patents that are part of
[***] or the [***] or [*** ]. If
Micromet does not want to continue the prosecution of any such
Patent, it will inform Bayer thereof in writing with sufficient
advance notice to reasonably enable Bayer to assume the filing or
prosecution of such Patent at its cost. If Bayer decides to assume
the filing or prosecution of such Patent, Micromet will assign such
Patent to Bayer. Notwithstanding the generality of the
foregoing, Micromet will provide to Bayer [***] of the
[***] Patent by providing to Bayer all draft filings in
advance of submission to the relevant patent authorities so that
Bayer can comment, provide input and demand changes to such
documents. Micromet will implement such proposed
changes, unless those changes would, in Micromet’s reasonable
belief, [***] or [***]. In any event,
Micromet will not abandon any claims or will not limit any claims
specific to the [***] without Bayer’s prior written
consent. Micromet will file and maintain such Patents at
its costs in the countries specified in Exhibit H
and advance notice regarding the timing of filings in
such countries. If Bayer wishes any such Patents to be
filed and maintained in additional countries, it will notify
Micromet accordingly and Micromet will file such Patents in such
countries at Bayer’s cost.
***
Certain confidential information contained in this document, marked
by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
7.8.3 Micromet
Licensed Patents . Except as provided in Section
7.8.2, Micromet will file, prosecute, defend and maintain at its
costs and in its name any Patents within the Micromet
Technology. Micromet will provide Bayer with an annual
oral report summarizing the status of patent applications, office
actions (including restriction requirements) and substantive
correspondence with the applicable patent office for such Patents
and made during such annual year.
7.8.4 Cooperation.
Each Party will keep the other Party
reasonably informed of progress with regard to its filing,
prosecution and maintenance of the Patents pursuant to this Section
7.8, and will consider in good faith the requests and suggestions
of the other Party with respect to the foregoing. Each
Party will provide the other Party with quarterly reports
summarizing (or providing copies as reasonably requested) of patent
applications, office actions (including restriction requirements)
and substantive correspondence with the applicable patent office
for such Patents and made during such preceding calendar
quarter. Further, each Party will cooperate with
the other Party, execute all lawful papers and instruments and make
all rightful oaths and declarations as may be necessary in the
preparation, prosecution and maintenance of all patents and other
filings referred to in this Section 7.8.
7.9
Enforcement of Patents .
7.9.1 Notice.
If either Party learns that a Third
Party is infringing or allegedly infringing any Patent within the
Licensed Technology or the [***] to the extent related to a
Product, it will promptly notify the other Party thereof including
available evidence of infringement. The Parties will
cooperate and use reasonable efforts to stop such alleged
infringement without litigation.
7.9.2 Enforcement
Actions.
(a) The
Party owning a Patent within the Licensed Technology or the [***]
will have the first right (but not the obligation) to take the
appropr
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