TERMINATION AND LICENSE AGREEMENT
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EXECUTION
VERSION
This
Termination and License Agreement (the “Agreement”) is made and
entered into effective as of November 4, 2009 (the “Effective Date”), by and
between Micromet AG, having its principal place of business at Xxxxxxxxxxxxxxxxx
0, 00000, Xxxxxx, Xxxxxxx (“Micromet”), and MedImmune,
LLC, having its principal place of business at Xxx XxxXxxxxx Xxx, Xxxxxxxxxxxx,
XX 00000 (“MedImmune”). Micromet
and MedImmune each may be referred to herein individually as a “Party,” or collectively as the
“Parties.”
RECITALS
WHEREAS
the Parties have entered into a Collaboration and License Agreement (as defined
below);
WHEREAS
the Parties desire to terminate the Collaboration and License
Agreement;
WHEREAS
pursuant to such termination, MedImmune is surrendering rights to the Licensed
Product (as defined in the Collaboration and License Agreement), including the
rights provided under Section 3.6.2 thereof; and
WHEREAS
the Parties desire that the rights and obligations of the Parties with respect
to the Licensed Product (as defined below) be governed by this
Agreement.
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:
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AGREEMENT
1.
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Definitions
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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; provided, however, that if
local law restricts foreign ownership, control will be established by direct or
indirect ownership of the maximum ownership percentage that may, under such
local law, be owned by foreign interests.
1.2 “Applicable Law” means the
laws, rules, and regulations, including any statutes, rules, regulations, or
other requirements, that may be in effect from time to time and that apply to
the development, manufacture, registration, and marketing of Licensed Product in
the United States and the European Union and its member states, including any
such statutes, rules, regulations, or other requirements of the FDA and the
EMEA.
1.3 “BiTE Molecule” means a
polypeptide comprising a bi-specific Single Chain Antibody binding to
T-cells.
*** 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.
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17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.4 “BiTE Product” means any
compositions or formulation containing a BiTE Molecule.
1.5 “BLA” means a Biologics
License Application filed with the FDA in conformance with applicable laws and
regulations.
1.6 “cGMP” means current Good
Manufacturing Practices as contained in 21 CFR Parts 210 and 211 as amended from
time to time, and the equivalent Applicable Laws in jurisdictions outside the
United States.
1.7 “Clinical Materials” has the
meaning set forth in Section 4.1.
1.8 “Collaboration and License
Agreement” means the Collaboration and License Agreement by and between
MedImmune, LLC (formerly MedImmune, Inc.) and Micromet AG, effective June 6,
2003 and any amendment thereto made prior to the Effective Date.
1.9 “Collaboration Technology”
means Joint Collaboration Technology or MedImmune Collaboration
Technology.
1.10 “Commercialization” means
marketing, promotion, advertising, selling or distribution of a Licensed
Product. The term Commercialize has a correlative
meaning.
*** 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.
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17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.11 “Control” and, with
correlative meaning, the term “Controlled,” means, with
respect to any Patent, Know-How, or other intellectual property right of a
Party, the ability to grant the other Party access, a license or a sublicense
(as applicable) or right to use such Patent, Know-How, or intellectual property
right as provided in this Agreement without violating the terms of any agreement
or other arrangement with any Third Party existing at the time such Party would
be required under this Agreement to grant the other Party such access, license,
sublicense or right of use.
1.12 “EMEA” means the European
Medicines Agency and any successor agency thereof.
1.13 “FDA” means the United States
Food and Drug Administration and any successor agency thereof.
1.14 “FTE” means the equivalent of
a total of [***] hours per year of scientific or technical work on or directly
related to tasks to be performed under this Agreement, carried out by a
qualified employee of MedImmune.
1.15 “FTE Rate” means US $[***] per
FTE per annum, which amount includes, for each FTE, [***] and [***], [***] costs
[***], and a [***] of [***] and [***] plus [***] expenses.
1.16 “IND” means the
Investigational New Drug Application #100135 (including all amendments and
supplements thereto) as filed with the FDA and in existence as of the Effective
Date.
*** 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.
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17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.17 “Independent MedImmune
Technology” means any Patent or Know-How, other than MedImmune
Collaboration Technology, and other than MedImmune Process Technology that (a)
is owned by MedImmune as of the Effective Date, and (b) in the case of Patents,
claims or covers the composition, use, or manufacture of a Licensed Product, in
each case as the foregoing is used or exists as of the Effective Date, or
compounds or materials used or employed in the manufacture or use thereof as of
the Effective Date or, in the case of Know-How, is useful with respect to any of
the foregoing. Independent MedImmune Technology does not include
Know-How with respect to the recipe of Media Materials.
1.18 “Joint Collaboration
Technology” means any Patents and Know-How made or generated jointly by
employees, or Third Party agents or independent contractors of both Parties or
their Affiliates during the course of, in furtherance of, and as a direct result
of such employees, agents or independent contractors performing an activity
pursuant to the Collaboration and License Agreement or this
Agreement.
1.19 “Know-How” means (a) any
scientific or technical information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, 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.
1.20 “Licensed Product” means MT103
alone or as part of a composition or formulation.
*** 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.
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17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.21 “MAA” means a marketing
approval application filed with the EMEA, and any corresponding applications in
countries or territories other than the European Union and other than the United
States.
1.22 “Manufacturing Process” means
the [***] process used by MedImmune as of the Effective Date to manufacture
Clinical Materials and/or Licensed Product.
1.23 “Marketing Approval” means the
approval of a BLA or MAA, and any pricing and reimbursement approvals to the
extent required by Applicable Law prior to the marketing and sale of
pharmaceutical products in a country.
1.24 “MedImmune Collaboration
Technology” means (i) the Patents listed on Exhibit A, and (ii) any
Know-How, (other than MedImmune Process Technology or Know-How directed to
manufacturing of any product,) made or generated solely by employees, or Third
Party agents or independent contractors of MedImmune or its Affiliates during
the course of, in furtherance of, and as a direct result of such employees,
agents or independent contractors performing an activity pursuant to the
Collaboration and License Agreement, and (iii) any Patents and Know-How made or
generated solely by employees, or Third Party agents or independent contractors
of MedImmune or its Affiliates (to the extent MedImmune has the ability to grant
such rights) during the course of, in furtherance of, and as a direct result of
such employees, agents or independent contractors performing Services or
consulting services pursuant to Section 5.6 of this
Agreement. MedImmune Collaboration Technology does not include
Know-How with respect to the recipe of Media Materials.
1.25 "Media Materials" as the
meaning set forth in Section 5.2(a).
*** 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.
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1.26 “MedImmune Process Technology”
means any Patents and Know-How that (i) in the case of Know How that is
Controlled by MedImmune as of the Effective Date and in each case that has been
used by MedImmune with respect to the Manufacturing Process, and (ii) in the
case of Patents, that are owned by MedImmune as of the Effective Date and would
be infringed by use of the Manufacturing Process. MedImmune Process
Technology does not include Know-How with respect to the recipe of Media
Materials.
1.27 “MT103” means the BiTE Product
containing the BiTE Molecule with the amino acid sequence set forth in Exhibit
B. Such BiTE Molecule is currently known as
blinatumomab.
1.28 “Net Sales” means the gross
amount invoiced to Third Parties or received from Third Parties without prior
invoice, in either case by Micromet, its Affiliates, or any of their licensees
for the sale of a Licensed Product, less: (a) trade, quantity and cash discounts
allowed; (b) commissions, discounts, refunds, rebates (including federal, state
or local government rebates), chargebacks, retroactive price adjustments, all to
the extent allowed; (c) refunds or credits for actual returns of a Licensed
Product; (d) any tax imposed on the production, sale, delivery or use of a
Licensed Product, including sales, use, excise or value added taxes, other than
income taxes; (e) freight and insurance costs included in the gross amount
invoiced; (f) a reasonable allowance for distribution expenses; and (g) actual
write-offs of uncollectible accounts receivable. Such amounts will be
determined from the books and records of Micromet or its Affiliate, or their
licensee in accordance with United States generally accepted accounting
principles as applied by such entity consistently across its
products. “Net Sales” excludes any amounts invoiced or received in
connection with any transfers of a Licensed Product between Micromet and its
Affiliates or their licensees who have the right to Commercialize a Licensed
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.
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1.29 “North America” means the
United States of America, Canada, and Mexico, and any territories or possessions
of the foregoing countries.
1.30 “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.
1.31 “Related Agreements” means
individually or collectively the following agreements: [***] between MedImmune,
LLC, MedImmune Pharma BV, and Micromet AG of [***]; [***] between MedImmune
Pharma BV, Micromet AG and Output Pharma Services GmbH of [***]; and [***]
between MedImmune, LLC and Micromet AG, dated [***].
1.32 “Royalty Term” has the meaning
set forth in Section 8.4.
1.33 "Services" has the meaning set
forth in Section 3.1.
1.34 “Single Chain Antibody” means
a single chain polypeptide having a binding affinity for a cell surface antigen,
and comprising: (a) a [***] having a [***], (b) a [***] having a [***], and (c)
at least [***] the [***] and [***] into a single chain polypeptide.
*** 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.
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1.35 “Technology Patent” means (i)
a Patent owned by or licensed to Micromet that contains a claim that covers the
making, using, selling, offering for sale or importing of a Licensed Product or
(ii) a Patent that is included in Independent MedImmune Technology or (iii) a
Patent that is included in MedImmune Process Technology or (iv) a Patent that is
included in Collaboration Technology.
1.36 “Territory” means the entire
world.
1.37 “Third Party” means any entity
other than Micromet, MedImmune or their respective Affiliates.
1.38 “Valid Claim” means an issued
claim of an issued patent that has not (a) expired or been canceled, (b) been
declared invalid by a decision of a court or other appropriate body of competent
jurisdiction that has not been appealed or that is not appealable, (c) been
admitted to be invalid or unenforceable through reissue, disclaimer or
otherwise, or (d) been abandoned or disclaimed.
2.
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Termination
and Release
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2.1 Termination. As of the
Effective Date, Micromet and MedImmune hereby terminate the Collaboration and
License Agreement and the Related Agreements and the rights and
licenses granted thereunder and any and all rights and obligations thereunder,
including those incurred prior to, as of or subsequent to the Effective Date,
and no rights or obligations of the Collaboration and License Agreement and the
Related Agreements will survive such termination, notwithstanding anything
therein to the contrary; provided, however, that the
Related Agreements will survive and apply with respect to the supply of Clinical
Materials by MedImmune in accordance with this Agreement. For the
avoidance of doubt, this Section 2.1 supersedes Articles 12 and 16 of the
Collaboration and License Agreement.
*** 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.
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2.2 Release. (a) Micromet, on
behalf of itself and its Affiliates, hereby releases and discharges MedImmune
and its respective subsidiaries, divisions, parents, Affiliates, agents and each
of its respective officers, directors, employees, representatives and agents,
and (b) MedImmune, on behalf of itself and its Affiliates, hereby releases and
discharges Micromet and its subsidiaries, divisions, parents, Affiliates, agents
and each of its respective officers, directors, employees, representatives and
agents, in each case ((a) and (b)), from any and all actions, claims,
counterclaims, defenses and damages whatsoever, known or unknown, in law or
equity, whether in tort or contract or otherwise, which the releasing Party ever
had, now has or hereafter will or may have, that can be, could be or could have
been asserted by Micromet or MedImmune in any judicial or non-judicial
proceeding which in each case arises out of or relates to any right obligation,
breach, action or inaction of Micromet or MedImmune with respect to the
Collaboration and License Agreement and the Related Agreements. For
the avoidance of doubt, the release of this Section 2.2 is not applicable to
actions, claims, counterclaims, defenses and damages that arise out of this
Agreement.
2.3 Research Agreement.
Notwithstanding termination of the Collaboration and License Agreement and the
rights and licenses granted to MedImmune thereunder, the Parties acknowledge and
agree that the BiTE Research Collaboration Agreement by and between the Parties,
effective as of June 6, 2003 (the “Research Agreement”), remains
in full force and effect and that the releases of Section 2.2 of this Agreement
are not applicable to the rights and obligations of the Parties under the
Research Agreement. The Parties further acknowledge and agree that
Know-How (as defined in this Agreement) of Micromet with respect to the Licensed
Product (as defined in this Agreement) that is useful with respect to
Collaboration Products (as defined in the Research Agreement) is included in
Independent Micromet Technology (as defined in the Research
Agreement).
*** 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.
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Treatment Requested
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3.
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Work
to be Performed By MedImmune
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3.1 Services. MedImmune
will use commercially reasonable efforts to perform the services set forth in
Exhibit C (the “Services”) within the time
frames described therein. Micromet acknowledges and agrees that the
performance of the Services may not result in a desired or stated result and
MedImmune has no liability to Micromet for failing to achieve a desired or
stated result and no obligation to repeat such Services for
Micromet.
3.2 Price. With respect to the
Services, Micromet will pay to MedImmune the FTE Rate for MedImmune employees
performing such Services and the amount paid by MedImmune to a Third Party in
relation to such Services. Such amount will be due and payable by
Micromet to MedImmune within [***]([***])[***] of invoice therefor and such
invoices will be submitted no more frequently than once per
month. Each invoice will include a description of the number of FTE
hours charged for the performance of the Services and a description of the
Services performed during the billing period. MedImmune will not be
obligated to perform Services and Micromet will not be obligated to pay for
Services that exceed the budget of Exhibit C unless Micromet agrees in writing
to pay for such Services in excess of such budget.
*** 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.
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4.
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Supply of Clinical
Materials
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4.1 Clinical Materials. To the
extent not already delivered on or prior to the Effective Date, MedImmune will
deliver to Micromet the materials set forth in Exhibit D (the “Clinical Materials”) to be
paid for by Micromet at the price set forth in Exhibit D (the “Price”). Except as
set forth in this Section 4.1, MedImmune will not be obligated to supply
Micromet with any Licensed Product, Clinical Materials or any products or
materials used in or for the production of Licensed Product except for
MedImmune’s obligations with respect to Media Materials under Section
5.2(b).
4.2 Packaging, Shipping and
Delivery. MedImmune will ship the Clinical Materials [***]
(Incoterms 2000) [***] facility by a common carrier designated by
Micromet. Each shipment will be made under the terms and conditions
set forth in this Agreement. Each shipment will include a certificate
of analysis and a certificate of compliance and will be released by MedImmune
Pharma BV’s qualified person for import, labeling and distribution to clinical
trial sites.
4.3 Risk of Loss. Risk
of loss of Clinical Materials will be transferred to Micromet upon delivery to
the carrier, and thereafter with respect to any loss thereof, Micromet will be
responsible for payment to MedImmune for such Clinical Materials.
4.4 Invoice and
Payment. Within [***]([***])[***] of acceptance of a shipment
of Clinical Materials, Micromet will pay to MedImmune the Price for the Clinical
Materials as set forth in an invoice therefor.
*** 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.
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4.5 Warranties. MedImmune
hereby warrants that any Clinical Materials provided by MedImmune to Micromet
under this Agreement, at the time of delivery: (a) will conform to the
specifications for such Clinical Materials set forth in Exhibit D (the “Specifications”), and (b) will
have been manufactured and shipped to Micromet in accordance with cGMP and
Applicable Laws (collectively, the “Product
Warranties”).
4.6 Acceptance of Clinical
Materials. Micromet will have [***]([***])[***] after receipt
of each shipment of Clinical Materials (such period, the “Acceptance Period”) to review
such shipment and test the Clinical Materials therein. If Micromet
believes that the Clinical Materials do not comply with the Product Warranties,
then Micromet will deliver to MedImmune written notice of rejection (the “Rejection Notice”) of such
Clinical Materials, stating in reasonable detail the basis for such assertion of
non-compliance with the Product Warranties. Any Clinical Materials
not rejected within such [***]([***])[***] period will be deemed to be accepted
by Micromet; provided,
however, that Micromet thereafter may send a Rejection Notice for
Clinical Material promptly following the discovery of any failure to comply with
the Product Warranties if such non-compliance was not reasonably discoverable
within such [***] period (each such non-compliance a “Latent Defect”). If
a Rejection Notice is received by MedImmune during the Acceptance Period, or
thereafter as permitted with respect to Latent Defects, then MedImmune and
Micromet will provide one another with all related paperwork and records
(including quality control tests) relating to the production of the Clinical
Materials in question or the Rejection Notice.
*** 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.
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17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
4.7 Disputes
Regarding Clinical Trial Materials.
(a) MedImmune
and Micromet will attempt to resolve any dispute regarding the conformity of a
shipment of Clinical Materials with the Product Warranties. If such
dispute cannot be settled within [***]([***])[***] of the submission by each
Party of such related paperwork and records to the other Party, then such
dispute will be resolved as set forth in this Section 4.7.
(b) If
the Clinical Materials are alleged not to conform with the Product Warranties
set forth in Section 4.5(a), then Micromet will submit a sample of the batch of
the disputed shipment to an independent testing laboratory of recognized repute
selected by Micromet and approved by MedImmune (such approval not to be
unreasonably withheld) for analysis, under Quality Assurance approved
procedures, of the conformity of such shipment of Clinical Materials with the
applicable Specifications. The costs associated with such analysis by
such independent testing laboratory will be paid by the Party whose assessment
of the conformity of the shipment of Clinical Materials with the Specifications
was mistaken. The determination by the independent testing
laboratory, will be final and binding.
(c) If
the Clinical Materials are alleged not to conform with the Product Warranties
set forth in Section 4.5(b), then such dispute will be submitted to an
arbitrator located in the state where the Clinical Materials are
manufactured. Such arbitrator will have adequate scientific
background and training and will be selected jointly by Micromet and
MedImmune. Such arbitrator, in accordance with the commercial
arbitration rules of the Judicial Arbitration and Mediation Services (“JAMS”), will determine whether
the Clinical Materials were non-conforming with the Product Warranties set forth
in Section 4.5(b), and such arbitrator’s findings, will be final and
binding. The costs and expenses associated with the retention of such
arbitrator will be paid by the Party whose assessment of the conformity of the
shipment of Clinical Trial Materials with the Product Warranties was
mistaken.
*** 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.
***Text Omitted and Filed
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17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
4.8 Remedies for Non-Conforming Clinical
Materials. In the event that the Parties agree, or an
independent testing laboratory or an arbitrator determines, pursuant to Section
4.7, that all or a portion of a shipment of Clinical Materials fails to conform
to the Product Warranties, then, as the sole and exclusive remedy for such
failure, Micromet will not be obligated to make any payment for such
non-conforming Clinical Materials and MedImmune will reimburse any payments for
such materials previously received from Micromet.
4.9 Audits and Inspections.
(a) Micromet
will have the right to inspect and audit (i) the facilities of MedImmune and
Third Parties in which cGMP production for Licensed Product, Media Materials,
and bag diluent was produced but only to the extent that such facilities are in
operation and (ii) the documentation generated in connection with the
manufacture and testing of Licensed Product, Media Materials and bag
diluent. MedImmune will have the right to redact documents to the
extent they contain the recipe for Media Materials. With respect to a
Third Party facility and documentation, subject to any confidentiality
requirements of the Third Party, MedImmune will use reasonable efforts to cause
any such Third Party to permit such inspection and audit (but excluding the
recipe of any Media Materials). Such inspection and audit will take
place during regular business hours with at least [***]([***])[***] prior notice
to MedImmune. Micromet will discuss the results of any inspection and
audit with MedImmune. Micromet’s right to inspect and audit is
limited to [***] and [***] per [***].
*** 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.
***Text Omitted and Filed
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Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(b) MedImmune
will permit a regulatory authority to inspect and audit the (i) the facilities
of MedImmune and Third Parties in which cGMP production for Licensed Product,
Media Materials, and bag diluent was produced but only to the extent that such
facilities are in operation and (ii) the documentation generated in connection
with the manufacture and testing of Licensed Product, Media Materials and bag
diluent. Micromet will pay all of the cost and expense thereof
including but not limited to those incurred by [***]. A
representative from Micromet will have the right to be present [***] at any such
inspections or audits by a regulatory authority. Such representative
from Micromet will [***] the [***] to [***] in [***] in the event a regulatory
authority requests information that is not related to the Manufacturing
Process. MedImmune will promptly provide Micromet with copies of
inspection requests from any regulatory authority.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
5.
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Transfer
of Manufacturing Process and
Regulatory
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5.1 Technology
Transfer.
(a) As
promptly as possible but no later than [***], Micromet will identify to
MedImmune a contract manufacturing organization that will manufacture Licensed
Product for Micromet. Subject to such contract manufacturing
organization executing an agreement pursuant to Section 5.4, MedImmune will
provide Micromet and such identified manufacturer (to the extent not previously
provided by MedImmune) with the Know-How in its possession as of the Effective
Date that is MedImmune Process Technology, which includes, but is not limited
to, and in each case that exists as of the Effective Date, technical reports and
materials for process development activities that are relevant to and would be
required for Micromet or its contract manufacturing organization to
perform such Manufacturing Process (including but not limited to any master cell
banks, working cell banks, fermentation processes, recovery steps established,
process validation, product identity assays, in-process-control assays, relevant
standard operating procedures, as well as samples of the working cell bank
prepared at MedImmune, and technical methods for assays required for the
applicable process. For clarity, all Know-How within MedImmune
Process Technology in tangible form (except for biological, chemical, or
physical materials) to be provided under this Section 5.1(a) are listed in
Exhibit E-3. In addition, MedImmune will have the right to redact the
documents to the extent they contain information that is not related to
Manufacturing Process or information related to the recipe of Media
Materials.
(b) Promptly
after the Effective Date, the MedImmune Project Manager, his counterpart at
Micromet, and other appropriate personnel of MedImmune and Micromet will meet to
establish a plan for the transfer of the Manufacturing Process and the MedImmune
Process Technology as is reasonable and customary in the industry for the
transfer of manufacturing processes and designed to complete the transfer of the
Manufacturing Process and the MedImmune Process Technology within the timeframe
set forth in subsection (c) below (the “Transfer Plan”), which
Transfer Plan will be deemed part of this Agreement and incorporated herein by
reference. Within [***]([***])[***] from the date on which MedImmune
is informed of the contract manufacturing organization (“CMO”) selected by Micromet for
the manufacture of the Licensed Product, MedImmune will make appropriate
personnel available to meet with the CMO to initiate such process
transfer.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) MedImmune
will use commercially reasonable efforts to complete transfer of the
Manufacturing Process and the MedImmune Process Technology to such manufacturer
within [***]([***])[***] from that first meeting. Such timelines will
be extended for delays that are reasonably outside the control of MedImmune,
including but not limited to delays related to the performance of Micromet, its
contract manufacturer, or licensees. Upon completion of the transfer
of the Manufacturing Process and the MedImmune Process Technology, MedImmune
will not have any further obligations to provide additional MedImmune Process
Technology to Micromet or its manufacturer.
(d) MedImmune's
obligation with respect to the Manufacturing Process and the MedImmune Process
Technology is limited to transfer of the Manufacturing Process Technology in
accordance with this Section 5.1 and providing consulting services pursuant to
Section 5.6 and MedImmune does not covenant, warrant or represent that the
Manufacturing Process and/or the MedImmune Process Technology when used by or on
behalf of Micromet or its sublicensees will be suitable for producing Clinical
Materials and/or Licensed 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
5.2 Supply of Cell Culture Media and
Nutrient Feeds.
(a) Promptly
after the Effective Date, MedImmune will introduce Micromet to MedImmune’s
current contract manufacturer(s) (individually a “Media Supplier” and
collectively the “Media
Suppliers”) for the cell culture media and nutrient feeds used in the
Manufacturing Process (the “Media Materials”) and will
reasonably cooperate with Micromet and the Media Suppliers in the establishment
of a direct supply agreement between Micromet and a Media Supplier for the
purchase and supply of the component(s) of the Media
Materials. MedImmune will permit the Media Supplier to supply the
Media Materials (but not the recipe to such Media Materials) to Micromet during
the Term of this Agreement.
(b) Promptly
after the Effective Date, MedImmune will deliver to Micromet or its designee the
Media Materials listed in Exhibit H. In addition, in the event that
(i) Micromet is [***] to [***] a [***] with a [***] for a necessary component of
the Media Materials [***] within a period of [***]([***])[***] from the
Effective Date after having used reasonable efforts to do so, or (ii) if a [***]
its [***] with Micromet (except in the event of such [***] for [***] by [***] of
this Agreement or its agreement with a Media Supplier), or (iii) in the event
such [***] is [***] to [***] the [***] to Micromet, then MedImmune will provide
Micromet (or Micromet’s contract manufacturer or licensee manufacturing the
Licensed Product) with Micromet’s (or such contract manufacturer’s or
licensee’s) commercially reasonable requirements of the Media Materials
necessary for the manufacture of the Licensed Product at cost pursuant to a
separate supply agreement to be executed promptly after the Effective Date,
which agreement will include the terms set forth in this Section 5.2(b)
(including terms for reasonable advanced forecasts for Media Materials) and such
other terms that are consistent with the terms under which MedImmune purchases
Media Materials from its third party supplier.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) Micromet
will not, and will cause its Affiliates, licensees and their respective
manufacturers not to (i) directly or indirectly, take any steps to ascertain the
recipe of any Media Materials provided by MedImmune and/or a Media Supplier, and
(ii) to not use the Media Materials for any purpose other than manufacturing
Licensed Product. In the event Micromet, its Affiliates, licensees,
or their respective manufactures ascertains or receives the recipe of any Media
Material through no fault of its own, Micromet will and cause its Affiliates,
licensees, and their respective manufacturers to promptly inform MedImmune of
such event and destroy such information.
(d) MedImmune
will provide (at Micromet’s cost) to Micromet, or at the discretion of MedImmune
to the applicable regulatory agencies, all necessary CMC documentation in its
possession relating to Media Materials required for regulatory filings for the
Licensed Product.
(e) MedImmune
may elect to terminate supply of some or all of the Media Materials by providing
Micromet with the recipes therefor, in which case MedImmune’s obligation to
supply such component of the Media Materials will expire, and Micromet will
terminate any supply agreements with the applicable Media Supplier(s) no later
than [***]([***])[***] after MedImmune provides the recipes.
5.3 Cost of
Transfer. Except for the internal FTEs of MedImmune (not to
exceed [***]([***]) FTEs total), the cost of which will be borne by MedImmune,
Micromet will pay all of the cost and expense (including the cost and expense of
Third Parties) for transfer of the Manufacturing Process and the MedImmune
Process Technology to Micromet or any Third Party pursuant to this
Agreement. In the event MedImmune’s internal costs exceed
[***]([***]) FTEs, Micromet will reimburse MedImmune for such costs above
[***]([***]) FTES within [***]([***])[***] of invoice therefor.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
5.4 Process
Transfer. Micromet will have the right to transfer the
Manufacturing Process and/or, the MedImmune Process Technology and/or Media
Materials to any Affiliate and to any Third Party (which may include a licensee
of Micromet) that is to manufacture Licensed Product for Micromet or its
licensees; provided,
however, that prior to such transfer, such Third Party will execute the
agreement with MedImmune in the form attached hereto as Exhibit F which will
require it to comply with the restrictions of Section 5.2 as to Media Materials
and that contains confidentiality and non-use obligations substantially similar
to those set forth in this Agreement with respect to Confidential Information of
MedImmune. Except as provided in this Section 5.4 and in Section
6.1(d), Micromet will not transfer Media Materials and/or transfer Know-How that
is MedImmune Process Technology or the Manufacturing Process to any Third
Party. In the event that an agreement between Micromet and a Third
Party with respect to Licensed Product is terminated, Micromet will notify
MedImmune of such termination within [***]([***])[***] of such
termination.
5.5 Non-Clinical, Clinical and Regulatory
Documentation. MedImmune will transfer to Micromet the
clinical and non-clinical information and documentation listed in Exhibit E-1
within [***]([***])[***] from the Effective Date. The Parties acknowledge that
MedImmune has transferred to Micromet the clinical and regulatory filings and
documentation listed in Exhibit E-2, including the (i) IND, (ii) all regulatory
correspondence related to the IND, (iii) all orphan drug designations and all
amendments, and (iv) all regulatory correspondence related to the orphan drug
designations. The Parties acknowledge that MedImmune has also transferred to
Micromet the safety database relating to the Licensed 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
5.6 Consulting
Services. From time to time, Micromet may submit to MedImmune
a written request to the designated MedImmune Project Manager as defined in
Section 5.7 to provide consulting services to Micromet with respect to the
Manufacturing Process, which request will include the specifics of the
consulting services being requested. Micromet will provide at least
[***]([***])[***] advanced notice for all such requests to
MedImmune. In the event that [***] has [***] about the [***], then
MedImmune will use reasonable efforts to promptly provide such consulting
services. For the avoidance of doubt, MedImmune will not be required
to provide general process development consulting services that could be
provided by any contract manufacturing organization. In no event will
MedImmune be obligated to provide more than [***]([***])[***] of consulting
services in any [***], or more than [***]([***])[***] of consulting services for
any [***]. Micromet will pay for such consulting services rendered at
the FTE Rate, within [***]([***])[***] of invoice
therefor. MedImmune’s obligation to provide these consulting services
will expire [***]([***])[***] after Micromet files the first MAA or the first
BLA for the Licensed Product, whichever is earlier. For the avoidance
of doubt such consulting services will not require MedImmune to perform any of
the following:
(a) generate
new scientific data or make any changes to the Manufacturing
Process;
(b) write
or create additional reports, manuscripts, or regulatory documents;
(c) have
direct interaction or correspondence with any regulatory agency except matters
relating to Media Materials as described in Section 5.2(d) or with respect to
inspections by such regulatory agency as provided in Section 4.9;
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(d) disclose
any Know-How that was not used by MedImmune in the Manufacturing Process
existing as of the Effective Date.
For the
avoidance of doubt, MedImmune has no obligation to provide consulting services
to Micromet with respect to any subject matter other than the Manufacturing
Process. Notwithstanding the preceding sentence, MedImmune as part of
the Consulting Services will use commercially reasonable efforts to provide any
raw data, report, or other tangible Know-How within MedImmune Process Technology
(in each case to the extent such Know-How is in its possession and was not
previously provided to Micromet or its contract manufacturer) that is necessary
to establish the Manufacturing Process, to generate additional reports, to
respond to the inquiry of any regulatory authority or to be included as part of
any regulatory filing in connection with the Manufacturing Process, subject to
the limitations of this Section 5.6.
5.7 Project
Manager. MedImmune will
appoint a primary contact person to represent MedImmune (“MedImmune Project Manager”) in
its provision of the services under this Agreement, including those in Articles
3, 4, and 5. All requests by Micromet regarding MedImmune’s services
hereunder will be coordinated through the MedImmune Project Manager, and
Micromet will not directly contact other employees of MedImmune unless
previously authorized by the MedImmune Project Manager.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
6.
|
License Grants
|
6.1 Licenses
granted by MedImmune.
(a) Subject
to the terms and conditions set forth in this Agreement, MedImmune hereby grants
to Micromet an exclusive (even as to MedImmune), royalty-bearing, right and
license, with the right to grant and authorize the grant of sublicenses, under
the Independent MedImmune Technology and Collaboration Technology, to make, have
made, use, offer for sale, sell, and import Licensed Products in the
Territory.
(b) Subject
to the terms and conditions set forth in this Agreement, MedImmune hereby grants
to Micromet a co-exclusive (with MedImmune), royalty-free right and license,
with the right to grant and authorize the grant of sublicenses, under the
Collaboration Technology to make, have made, use, offer for sale, sell, and
import any BiTE Product (other than any BiTE Product as to which MedImmune is
exclusively licensed under the Research Agreement) in the
Territory. The license set forth in this Section 6.1(b) is exclusive
except as to MedImmune and its licensees. For the avoidance of doubt,
the license granted under this Section 6.1(b) does not include any MedImmune
technology that is not Collaboration Technology.
(c) Subject
to the terms and conditions set forth in this Agreement, MedImmune hereby grants
to Micromet an exclusive (even as to MedImmune), royalty-bearing, right and
license, with the right to grant sublicenses as permitted by Section 6.1(d),
under MedImmune Process Technology, to make and have made Licensed Product for
sale and use in the Territory.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(d) Except
to any licensee of rights to the Licensed Product or a contract manufacturer for
Micromet, its licensee or their respective Affiliates pursuant to and in
accordance with Section 5.4, Micromet will not sublicense, transfer or disclose
the Manufacturing Process or the MedImmune Process Technology or provide the
Media Materials to a Third Party without the prior written consent of MedImmune
and then only subject to such Third Party executing the agreement with MedImmune
in the form attached hereto as Exhibit F providing for confidentiality and
non-use provisions to protect the Confidential Information of MedImmune and/or
the Media Materials.
(e) Other
than the case where a sublicensee of Micromet has entered into an agreement with
MedImmune that indemnifies MedImmune in a manner substantially identical to the
indemnification of Section 14 of this Agreement (including a CMO that has
executed the confidentiality agreement in the form attached as Exhibit F), any
sublicense granted under this Section 6.1 will require the sublicensee to
indemnify MedImmune in accordance with Section 14 of this Agreement, and
Micromet will use reasonable efforts to have MedImmune designated as third party
beneficiary thereof with the right to enforce. In the event that
MedImmune is not a third party beneficiary, Micromet agrees that MedImmune will
have the right to enforce such indemnity provisions in the name of
Micromet.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(f) Any
sublicense granted by Micromet will be made subject to and in accordance with
the terms of this Agreement. If a sublicensee of Micromet commits any
act or omission relating to (i) MedImmune’s Confidential Information disclosed
by Micromet to such sublicensee, (ii) the practice of the sublicense granted by
Micromet under the licenses granted to it in this Agreement outside the scope of
the license granted to Micromet, (iii) the use or disclosure of MedImmune’s
confidential Know-How or (iv) Media Materials, in each case which act or
omission, if committed by Micromet, would constitute a material breach of this
Agreement, then Micromet will, upon request of MedImmune, terminate the
sublicense agreement with such sublicensee if such material breach is not cured
within [***]([***])[***] from notice thereof. Promptly upon execution
of each agreement under which Micromet grants a sublicense under the licenses
granted by MedImmune to Micromet under this Agreement, Micromet will provide to
MedImmune a copy of such sublicense agreement with financial provisions and
scientific, technical and other proprietary business information
redacted.
(g) Micromet
hereby covenants and agrees not to grant any Third Party any license or right
under Independent MedImmune Technology or MedImmune Process Technology, or Media
Materials to develop or Commercialize any product other than Licensed Product in
the Territory and not to use or practice Independent MedImmune Technology or
MedImmune Process Technology except as expressly permitted by this
Agreement. For the avoidance of doubt, nothing in this Agreement will
limit Micromet’s rights to use or grant Third Parties the right to use
information or Know-How Controlled by Micromet that was originally transferred
by Micromet to MedImmune under the Collaboration and License Agreement, or to
use information or Know-How Controlled by Micromet that was used or developed by
or on behalf of Micromet independent of or prior to the transfer of MedImmune
Process Technology to Micromet under this Agreement or the Collaboration and
License Agreement.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(h) Micromet
hereby covenants and agrees not to grant any Third Party any license or right
under MedImmune Collaboration Technology, or Media Materials to develop or
Commercialize any product other than BiTE Products in the Territory and not to
use or practice MedImmune Collaboration Technology except as expressly permitted
by this Agreement.
(i) MedImmune
hereby covenants and agrees that it will not license, assign or otherwise
transfer to any Third Party any of its right and interest in and to any Patent
that is Joint Collaboration Technology or MedImmune Collaboration Technology or
Media Materials for research, development, manufacture, use or Commercialization
of any BiTE Product, except in connection with co-developing a BiTE Product(s)
with such Third Party. This limitation is not applicable to any BiTE
Product as to which MedImmune holds a license under any other agreement with
Micromet or its Affiliates.
6.2 Bankruptcy Provision under US
Law. All rights and licenses granted under or pursuant to this Agreement,
including amendments hereto, by MedImmune to Micromet are, for all purposes of
Section 365(n) of Title 11 of the U.S. Code (“Title 11”), licenses of rights
to intellectual property as defined in Title 11. All rights, powers
and remedies of Micromet provided in this Section 6.2 are in addition to and not
in substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity (including Title 11) in the event of the
commencement of a Title 11 case by or against MedImmune. In such
event, Micromet will be entitled to exercise all other such rights and powers
and resort to all other such remedies as may now or hereafter exist at law or in
equity (including under Title 11).
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
7.
|
Prosecution,
Enforcement and Defense of
Patents
|
7.1 Prosecution
and Maintenance of Patents.
(a) MedImmune
will have the sole right to file, prosecute and maintain Patents that are
Independent MedImmune Technology or MedImmune Process Technology and/or
MedImmune Collaboration Technology.
(b) With
respect to Patents in the Collaboration Technology, MedImmune will provide to
Micromet all documents that relate to patent filing, prosecution and
maintenance, including each patent application, office action, response to
office action, request for terminal disclaimer, request for reissue or
reexamination and opposition or appeal proceedings or extension of any patent
issuing from such application sufficiently prior to the filing of such
application, response or request to allow for review and comment by
Micromet. MedImmune agrees to consider in good faith and to take into
account all comments received from Micromet.
(c) If
MedImmune decides to discontinue the prosecution of a Patent or abandon an
issued Patent within Collaboration Technology, it will inform Micromet thereof
not less than [***]([***])[***] in advance of the deadline at which an action is
required to be taken in order to continue such prosecution of, or to maintain
such Patent, and upon request of Micromet, will allow Micromet to continue the
prosecution or maintenance of such Patent on behalf of MedImmune at Micromet’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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
7.2 Enforcement
of Patents.
(a) Within
the Territory, with respect to the alleged infringement by a Third Party of a
Patent that is MedImmune Collaboration Technology or MedImmune Process
Technology or Independent MedImmune Technology licensed to Micromet under this
Agreement (a “Product
Patent”) by making, using, selling, importing or offering for sale a
Licensed Product (a “Product
Infringement”), with the prior written consent of MedImmune, which
consent may be granted or withheld in the sole discretion of MedImmune, Micromet will have the
right (but not the obligation) to bring an infringement action or proceeding
with respect to a Product Infringement at the cost and expense of Micromet, by
counsel of its own choice. MedImmune will have the right, at its own
cost and expense, to be represented in any such action by counsel of its own
choice. If Micromet fails to bring such an action in the Territory
within [***]([***])[***] of written notice thereof from MedImmune to Micromet,
then MedImmune will have the right to bring such action at the cost and expense
of MedImmune with counsel selected by MedImmune. Micromet, at its
cost and expense, will have the right to be represented by counsel in any such
action brought by MedImmune.
(b) If
one Party brings any enforcement action or proceeding under this Section 7 with
respect to a Product Infringement, the other Party agrees to be joined as party
plaintiff if necessary to prosecute the action or proceeding and to give the
first Party reasonable assistance and authority to file and prosecute the suit;
provided, however, that
neither Party will be required to transfer any right, title or interest in or to
any property to the other Party or any other party to confer standing on a Party
hereunder. The Party bringing the action will have the right to
control such action, including the settlement thereof, provided, however, that no
settlement will be made that adversely affects the validity, enforceability or
scope of a Patent within MedImmune Collaboration Technology or MedImmune Process
Technology or Independent MedImmune Technology unless agreed to in writing by
both Parties, such agreement not to be unreasonably withheld, delayed or
conditioned. Any damages or other monetary awards recovered pursuant
to any suit, proceeding or other legal action taken under this Section 7.2 will
be allocated first to the costs and expenses of the Party bringing suit, and
second to the costs and expenses (if any) of the other Party that were
authorized by the Party bringing the suit, with any remaining amounts (if any)
to be allocated to the Party bringing suit and if the amount is allocated to
Micromet, such amount will be Net Sales subject to royalty under this
Agreement.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
8.
|
Fees
and Payments
|
8.1 Upfront
Fee.
(a) Micromet
will pay to MedImmune Six Million Five Hundred Thousand Dollars ($6,500,000)
which is non-refundable and non-creditable in the following
installments:
(i) Four
Million Dollars ($4,000,000) payable on January 8, 2010;
(ii) [***]
[***] payable on [***]; and
(b) Intentionally
left blank.
(c) As
to the installment due on [***], such payment is solely contingent upon Micromet
or its CMO having received the materials and reports of Exhibit E-3 prior to
such time. For the avoidance of doubt, if MedImmune delivers the
materials and reports of Exhibit E-3 after [***], then such payment will be due
and payable upon such delivery.
*** Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
8.2 Development
Milestones. Micromet will make the following non-refundable,
non-creditable payments to MedImmune in the amounts set forth below within
[***]([***])[***] of the occurrence of each of the following events with respect
to the first Licensed Product to achieve the applicable event:
Milestone
Event
|
Milestone
Payment
|
|
[***]
The [***] of [***] or [***] to a [***] to [***] in the
[***]
|
US$[***]
|
|
[***]
of a [***] for [***] in the [***]
|
US$[***]
|
|
[***]
of a [***] for [***] in the [***]
|
US$[***]
|
In the
event that Milestone Event 2 occurs, and the payment for Milestone Event 1 has
not been paid, then the milestone payment for Milestone Event 1 will be made
with the payment for Milestone Event 2. The aggregate of Milestone
Payments payable by Micromet under this Section 8.2 will not exceed
[***]($[***]).
8.3 Royalties.
(a) Subject
to the adjustments provided for in Section 8.5, Micromet will pay to MedImmune a
royalty equal to [***]([***]) of Net Sales of Licensed Product in North
America. For the avoidance of doubt, a sale that occurs outside of
North America for Licensed Product that is shipped for use in North America is
included in Net Sales in North America.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(b) In
the event that a Licensed Product is sold in combination with a therapeutically
active component that is not a Licensed Product (“Combination Product”), then
net sales (calculated as Net Sales) of such Combination Product upon which a
royalty is paid will be subject to the following adjustment. If the
Licensed Product and the other therapeutically active component of the
Combination Product are sold separately in a country, then net sales of such
Combination Product in such country upon which a royalty is paid will be
multiplied by the fraction A/A+B, where A equals the average sales price of such
Licensed Product sold separately in such country, and B equals the average sales
price of the other therapeutically active component sold separately in such
country. Otherwise, the Parties will enter into good faith
negotiations and attempt to reach mutual agreement to determine an appropriate
adjustment to the net sales of such Combination Product in a country to reflect
the relative contributions of the Licensed Product and the other therapeutically
active component to the value of the Combination Product in such
country. If such mutual agreement is not reached within
[***]([***])[***] after commencement of such negotiations, then the
determination will be submitted to binding arbitration under Section
17.4(c).
(c) Only
one royalty will be due and payable for the manufacture, use and sale of
Licensed Product irrespective of the number of Valid Claims within Technology
Patents that cover the manufacture, use and sale of Licensed
Product. Upon payment of a royalty under this Agreement with respect
to a unit of Licensed Product, no further royalty will be due with respect to
such unit of Licensed 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
8.4 Royalty Term. On a
country-by-country basis, royalties due under Section 8.3 for Licensed Product
will begin on the first sale of Licensed Product following Marketing Approval in
a particular country in North America and continue on a country-by-country basis
until the later of: (i) the [***]of the [***] containing a [***] that [***] by
the [***] in the [***] of [***] where the [***] is [***], or (ii) [***]([***])
years from the first commercial sale following Marketing Approval of such
Licensed Product in such country in North America (the “Royalty Term”).
8.5 Royalty
Adjustments. In the event that one or more Third Parties sell
a Licensed Product in a country of North America and such sale (a) [***] a [***]
of a [***] or (b) [***] a [***] by [***] to [***] hereunder with respect to
which MedImmune declined Micromet’s request to permit Micromet’s enforcement of
such [***] against such Third Party infringer, and Micromet can demonstrate that
the revenues from sales of such Licensed Product by such Third Parties in such
country in such calendar year amounts to greater than [***]([***]) of the
revenues from sales of Licensed Product by Micromet or its licensees in such
country in such calendar year, then the royalty payable by Micromet pursuant to
Section 8.3 on Licensed Product in such country for such calendar year will be
reduced to [***]([***]). If sales by such Third Parties are only for
a portion of a calendar year, the greater than [***]([***]) of revenues from
sales will be determined over such portion of the calendar
year. Sales are to be calculated in the currency of the applicable
country and the reduction, if any, is determined on a calendar year by calendar
year basis such that the reduction is applicable in a calendar year in a country
only if Micromet demonstrates for such calendar year in such country that the
Third Party revenues from sales of Licensed Product exceeds [***]([***]) of the
revenues from sales of Licensed Product by Micromet or its licensees in such
country.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
8.6 Payment by
MedImmune. Within [***] after the Effective Date, MedImmune
will pay to Micromet €[***], which amount is non-refundable and non-creditable,
and consists of €[***] payable on account of past due amounts for costs and
expenses incurred by Micromet through [***] with respect to the clinical study
[***], and €[***] payable on account of past due amounts for costs and expenses
incurred by Micromet through [***] with respect to the clinical study
[***].
9.
|
Payment
Terms
|
9.1 Payment Method. All amounts
due to a Party will be paid in United States Dollars by wire transfer in
immediately available funds to an account designated by such
Party. The conversion for royalties will be made at the exchange rate
reported in the Wall Street Journal, Eastern Edition on the last business day of
the calendar quarter for which royalties are payable, and in all other cases at
such exchange rate on the date that the payment is due. Any payments
or portions thereof due hereunder which are not paid on the date such payments
are due under this Agreement will bear interest at the lower of (i) [***]% over
the overnight LIBOR rate in effect on the due date, or (ii) the maximum rate
permitted by law, calculated on the number of days such payment is delinquent,
compounded monthly.
9.2 Payment Schedules; Reports.
Royalty payments due pursuant to Section 8.3 are due and payable within
[***]([***])[***] of the end of each calendar quarter during the Royalty Term
during which there were Net Sales of the applicable product in North
America. Micromet will accompany each payment of royalties under this
Agreement with a report containing a detailed account of Net Sales of each
product for which royalties are due during the preceding calendar
quarter.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
9.3 Records
Retention; Audit.
(a) Micromet
will maintain complete and accurate books, records and accounts used for the
determination of royalties payable in connection with Net Sales, in sufficient
detail to confirm the accuracy of any payments required under this Agreement,
which books, records and accounts will be retained by Micromet until
[***]([***])[***] after the end of the period to which such books, records and
accounts pertain.
(b) MedImmune
will have the right to have an independent certified public accounting firm of
internationally recognized standing, reasonably acceptable to have access during
normal business hours, and upon reasonable prior written notice, to such of the
records of Micromet as may be reasonably necessary to verify the accuracy of any
payments received from Micromet for any calendar quarter ending not more than
[***]([***]) [***] prior to the date of such request; provided, however, that
MedImmune will not have the right to conduct more than one such audit in any
[***]([***]) [***] period. The accounting firm will disclose to the
Parties only whether the Net Sales reported by the audited Party are correct or
incorrect and the specific details concerning any discrepancies. The
auditing Party will bear all costs of such audit, unless the audit reveals a
discrepancy in the audited Party’s favor of more than [***]%, in which case the
audited Party will bear the cost of the audit. The results of such
accounting firm will be final, absent manifest error.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) If,
based on the results of any audit, additional payments are owed to a Party under
this Agreement, the amount of such payments will be credited against future
amounts payable by such Party to the other Party under this Agreement; provided, however, that if
such additional payments are not fully credited within [***] after the receipt
of the applicable audit results, the Party owing such additional payments will
at such time pay the other Party any uncredited amounts thereof.
(d) Each
party will treat all information subject to review under this Section 9 in
accordance with the provisions of Section 10 and will cause its accounting firm
to enter into a reasonably acceptable confidentiality agreement with the audited
Party obligating such firm to maintain all such financial information in
confidence pursuant to such confidentiality agreement.
10.
|
Confidentiality
|
10.1 Definition. “Confidential Information”
means (a) any Know-How, and (b) any scientific, manufacturing, marketing and
business plans, and financial and personnel matters relating to a Party or its
present or future products, sales, suppliers, customers, employees, investors or
business; in either case, that has been disclosed by or on behalf of such Party
to the other Party either in connection with the discussions and negotiations
pertaining to this Agreement or in the course of performing this Agreement
(including any information disclosed under the Confidentiality Agreement between
the Parties dated [***]) and any information disclosed under the Collaboration
and License Agreement).
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
10.2 Exclusions. Notwithstanding
the foregoing, any information of a Party will not be deemed Confidential
Information with respect to a receiving Party for purposes of this Agreement if
such information:
(a) was
already known or available to the receiving Party or its Affiliates, other than
under an obligation of confidentiality or non-use to the other Party, at the
time of disclosure to the receiving Party;
(b) was
generally available or known to parties reasonably skilled in the field to which
such information pertains, or was otherwise part of the public domain, at the
time of its disclosure to the receiving Party;
(c) became
generally available or known to parties reasonably skilled in the field to which
such information pertains, or otherwise became part of the public domain, after
its disclosure to the receiving Party through no fault of or breach of its
obligations under this Section 10 by the receiving Party;
(d) was
disclosed to the receiving Party, other than under an obligation of
confidentiality or non-use, by a Third Party who had no obligation to the Party
that Controls such information not to disclose such information to others;
or
(e) was
independently discovered or developed by the receiving Party or its Affiliates,
as evidenced by their written records, without the use of, and by personnel who
had no access to, Confidential Information belonging to the Party that Controls
such information.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
10.3 Disclosure and Use
Restriction. Except as expressly provided herein, the Parties
agree that, during the Term and for [***]([***]) [***] thereafter, each Party
and its Affiliates and sublicensees will keep completely confidential and will
not publish or otherwise disclose any Confidential Information of the other
Party, its Affiliates or sublicensees. Neither Party will use any
Confidential Information of the other Party without such other Party’s consent,
except as expressly permitted by this Agreement. Notwithstanding the
foregoing, in the event that MedImmune discloses the recipe of the Media
Materials to Micromet, the confidentiality obligations with respect thereto will
remain in full force and effect during the Term and without limitation
thereafter.
10.4 Authorized Disclosure. Each
Party may use and disclose Confidential Information of the other Party to the
extent that such use and disclosure is:
(a) made
in response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided, however, that such
Party will first have given notice to such other Party and given such other
Party a reasonable opportunity to quash such order and to obtain a protective
order requiring that the Confidential Information and documents that are the
subject of such order be held in confidence by such court or governmental or
regulatory body or, if disclosed, be used only for the purposes for which the
order was issued; and provided, further, that if a
disclosure order is not quashed or a protective order is not obtained, the
Confidential Information disclosed in response to such court or governmental
order will be limited to that information which is legally required to be
disclosed in response to such court or governmental order;
(b) otherwise
required by law, rule, or regulation; provided, however, that the
disclosing Party will provide such other Party with notice of such disclosure in
advance thereof to the extent practicable;
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) made
by such Party to the regulatory authorities as required in connection with any
filing of XXXx, Investigational New Drug Applications, BLAs, marketing approval
applications, or similar applications or requests for regulatory approvals;
provided, however, that
reasonable measures will be taken to assure confidential treatment of such
information;
(d) made
by such Party, in connection with the performance of this Agreement, to
Affiliates, permitted sublicensees, research parties, employees, consultants,
representatives or agents, each of whom prior to disclosure must be bound by
obligations of confidentiality and non-use at least equivalent in scope to those
set forth in this Section 10;
(e) made
by such Party to existing or potential acquirers or merger candidates; existing
or potential pharmaceutical collaborators (to the extent contemplated under this
Agreement); investment bankers; existing or potential investors, venture capital
firms or other financial institutions or investors for purposes of obtaining
financing; or Affiliates, each of whom prior to disclosure must be bound by
obligations of confidentiality and non-use at least equivalent in scope to those
set forth in this Section 10; or
(f) other
than Media Materials made in a patent application filed in conformance with this
Agreement.
10.5 Terms of Agreement to be Maintained
in Confidence. Subject to the provisions of this Section 10,
the Parties agree that the terms of this Agreement are deemed Confidential
Information of both Parties and will be subject to the restrictions on use and
disclosure set forth herein.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
11.
|
Public
Communications
|
11.1 Use of
Name. Neither Party will make public use of the other Party’s
name except (a) in connection with announcements and other permitted disclosures
relating to this Agreement and the activities contemplated hereby, (b) as
required by applicable law, rule, or regulation, and (c) otherwise as agreed in
writing by such other Party.
11.2 Press
Releases.
(a) Micromet
will have the right to issue the press release attached hereto as Exhibit G in
connection with the execution of this Agreement. Except with respect
to the terms of this Agreement that may be required to be disclosed under
Section 10.4(b), neither Party will make any public announcement regarding the
terms or the performance of this Agreement without the prior written approval of
the other Party. Any press release containing information to be
disclosed under the terms of Section 10.4(b) will be made only in accordance
with the terms thereof.
(b) A
Party may publicly disclose without regard to the preceding requirements of this
Section 11.2 information that was previously disclosed in compliance with such
requirements.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
11.3 Publications. MedImmune
will not make any publications or presentation of any material related to the
research or development activities performed by or on behalf of MedImmune under
the Collaboration and License Agreement or this Agreement except with prior
written consent of Micromet. Micromet will not make any publications
or presentations of any material related to the research or development
activities performed by or on behalf of MedImmune under the Collaboration and
License Agreement or this Agreement that identifies MedImmune as the originator
of the material, except with the prior written consent of
MedImmune.
12.
|
Term
and Termination
|
12.1 Term. The term of
this Agreement (the “Term”) will commence on the
Effective Date and will expire upon the earlier of (i) the [***] of the [***] or
(ii) [***] years from the Effective Date, unless earlier terminated as provided
in this Agreement.
12.2 Breach
by Micromet.
(a) In
the event that Micromet materially breaches a payment obligation under this
Agreement, in addition to any other remedy (but subject to Section 12.4),
including the right to bring an action to collect such payment, by [***]([***])
[***] prior written notice to Micromet, MedImmune will have the right to
terminate performance of its obligations under one or more
of Sections 3, 4 or 5, and if the payment breach is under Section 8.1
or 8.2, MedImmune will also have the right to send written notice to Micromet
that the provisions of Section 12.2(c) will come into effect unless such payment
breach under Section 8.1 or 8.2 is cured within [***]([***])
[***]. If such payment breach is not cured within the [***]([***])
[***] period, the termination of performance pursuant to notice and/or the
provisions of Section 12.2(c), as the case may be, will automatically become
effective. In the event that Micromet disputes a payment obligation
for which MedImmune provides notice under this Section and Micromet notifies
MedImmune of such dispute and makes the payment under protest within the
applicable [***]([***]) [***] period, then (i) termination of performance
pursuant to such notice and/or the provisions of Section 12.2(c) will not become
effective, and (ii) notwithstanding such payment, Micromet will have the right
to arbitrate under Section 17.4 whether or not Micromet is obligated to make
such payment and to the extent Micromet prevails in such arbitration, MedImmune
will return such disputed payments to Micromet with interest calculated in
accordance with Section 9.1.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(b) In
the event that Micromet breaches Micromet’s obligations under Sections 5.2 or
5.4 of this Agreement or Micromet’s obligations with respect to Media Materials,
MedImmune will have the right to send written notice to Micromet of such
breach. In the event that such breach is not cured within
[***]([***]) [***] or is not capable of cure, MedImmune will have the right to
terminate MedImmune’s obligations under Section 5.2 by written notice to
Micromet and Micromet will terminate all supply agreements for Media Materials.
In the event that Micromet disputes MedImmune’s claim that Micromet has breached
its obligations under Sections 5.2 or 5.4, Micromet will have the right to
arbitrate under Section 17.4 whether or not Micromet has breached such
obligations, and MedImmune will not have the right to terminate MedImmune’s
obligations under Section 5.2 until such breach has been found to exist in the
final judgment made by the arbitrator(s) in such arbitration.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) [***] will have the [***] to
[***] in the [***] under the terms and conditions set forth in Section [***]
which Section [***] is incorporated herein by reference, and will [***] of this
Agreement as set forth in Section 12.2(a) of this Agreement. Upon
[***] pursuant to Section [***] the [***] of the [***] that [***] into [***] as
a [***]of this Agreement to the extent required to effectuate the rights and
obligations of the Parties upon [***] of such [***] by [***] will provide [***]
to [***]or [***] that [***] of the rights of [***] with respect to [***] in the
[***] pursuant to Section 12.2 of this Agreement. Notwithstanding
anything else to the contrary,[***] will have the right to notify [***] to [***]
of [***] under Section 12.2 of this Agreement.
12.3 Breach by
MedImmune. In the event that MedImmune commits a material
breach of its obligations under one or more of Sections 3.1, 5.1 or 5.2 of this
Agreement, in addition to any other remedy (but subject to Section 12.4),
Micromet, will have the right prior to [***] to provide MedImmune with written
notice of such breach and the details thereof, and if such breach is not cured
within [***]([***]) [***] of such written notice, upon written notice to
MedImmune, Micromet will have the right to either:
(a) terminate
this Agreement in the entirety. In addition, Micromet will have the
right to pursue a claim for damages under Section 17.4 available to it under
law, subject to the limitations of Section 16.2(a) but not the limitations of
Section 16.2(b); or
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(b) elect
to keep this Agreement in full force and effect and initiate a proceeding under
Section 17.4 to determine whether MedImmune has committed a material breach of
its obligations under one or more of Sections 3.1, 5.1 or 5.2 of this
Agreement. Following a final determination under Section 17.4 that
MedImmune did commit such material breach that has not been cured, if in the
arbitration it is determined that such breach is not curable or if it is
determined in the arbitration that such breach is curable and MedImmune does not
cure such breach within [***]([***]) [***] after such determination, then (i)
the amount of future payments due to MedImmune under Section 8.2 will be
[***]([***]) and in no event [***] of the [***] set forth in [***] and (ii)
MedImmune will pay to Micromet any and all damages determined by such arbitrator
in such proceeding; provided,
however, that in any event such payment will not exceed
[***]($[***]). In any determination of whether MedImmune committed a
material breach, the arbitrator also will take into consideration the scope and
extent to which MedImmune performed such obligations under this Agreement and
the extent of the benefits received by Micromet with respect to such
performance.
12.4 Limitation on Termination
Rights. Each Party will only have the rights described above
in this Article 12 with regard to the termination of one or more provisions of
this Agreement and the Parties expressly acknowledge that except as provided in
Section 12.3(a) neither Party will have the right to terminate this Agreement in
its entirety, including on the basis of a material breach by a
Party.
13.
|
Effects
of Expiration or Termination
|
13.1 Accrued
Rights. Expiration or termination of this Agreement will be
without prejudice to any rights that will have accrued to the benefit of a Party
prior to the effective date of such expiration or termination. Such
expiration or termination will not relieve a Party from obligations that are
expressly indicated to survive the expiration or termination of this
Agreement
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
13.2 Survival. Article
2, Sections 9.1 and 9.2 (with respect to amounts unpaid as of the date of
expiration), 9.3, 10, 13, 14, 16 and 17, together with any definitions used or
exhibits referenced therein, will survive expiration of this
Agreement. Notwithstanding termination of a Party’s rights or
obligations under the Articles or Sections specified in Section 12.2, the rights
and obligations of the Parties under the other Articles and Sections of this
Agreement will remain in full force and effect. For the avoidance of
doubt, except as provided in Section 12.3(a), Micromets obligations to pay
upfront fees, milestones (subject to Section 12.3(b)) and royalties under
Article 8 will continue in full force and effect throughout the Royalty
Term.
13.3 Effect of Expiration on Intellectual
Property. Upon expiration of this Agreement pursuant to
Section 12.1 above, the licenses and sublicensing rights granted in Section 6.1
by MedImmune to Micromet will become fully paid, perpetual, and
irrevocable.
13.4 Effect of
Termination. Upon termination of this Agreement, the rights
and obligations of the Parties under this Agreement will be terminated, except
as provided in Section 13.2, and Micromet covenants and agrees to discontinue
and to cause its Affiliates and licensees to discontinue any and all use of
MedImmune Collaboration Technology and/or MedImmune Process Technology and/or
Independent MedImmune Technology and/or Media Materials.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
14. Indemnification
and Insurance
14.1 Indemnification of
MedImmune. Micromet will indemnify MedImmune and its
Affiliates, and their respective directors, officers, and employees (each, a
“MedImmune Indemnitee”),
and defend and save each of them harmless from and against any and all losses,
damages, liabilities, costs and expenses (including reasonable attorneys’ fees
and expenses) in connection with any and all liability suits, investigations,
claims or demands (collectively, “Losses”) arising from or
occurring as a result of any claim or lawsuit by a Third Party against a
MedImmune Indemnitee, to the extent caused by or arising out of: (a) negligence
or willful misconduct on the part of Micromet, its Affiliates or licensees in
performing any activity contemplated by this Agreement, or (b) the development
or Commercialization of Licensed Product in the Territory by Micromet, its
Affiliates or licensees; or (c) the use by Micromet, its Affiliates or licensees
of any Know-How provided under this Agreement or Patents licensed under this
Agreement, in each case, excluding any Losses to the extent that such Losses
arise out of the negligence or willful misconduct of a MedImmune
Indemnitee.
14.2 Notice of
Claim. All indemnification claims in respect of any MedImmune
Indemnitee under Section 14.1 (collectively, the “Indemnitees” and each an
“Indemnitee”) will be
made solely by MedImmune (the “Indemnified
Party”). The Indemnified Party will give Micromet (the “Indemnifying Party”) prompt
written notice (an “Indemnification Claim Notice”)
of any Losses or discovery of fact upon which such Indemnified Party intends to
base a request for indemnification under Section 14.1, but in no event will the
Indemnifying Party be liable for any Losses that result from any delay in
providing such notice. Each Indemnification Claim Notice must contain
a description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). The
Indemnified Party will furnish promptly to the Indemnifying Party copies of all
papers and official documents received in respect of any Losses.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
14.3 Control of
Defense. At its option, the Indemnifying Party may assume the
defense of any claim subject to indemnification as provided for in Section 14.1
(each, a “Third Party
Claim”) by giving written notice to the Indemnified Party within thirty
(30) days after the Indemnifying Party’s receipt of an Indemnification Claim
Notice. Upon assuming the defense of a Third Party Claim, the
Indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the Indemnifying Party. In the
event the Indemnifying Party assumes the defense of a Third Party Claim, the
Indemnified Party will immediately deliver to the Indemnifying Party all
original notices and documents (including court papers) received by any
Indemnitee in connection with the Third Party Claim. Should the
Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying
Party will not be liable to the Indemnified Party or any other Indemnitee for
any legal expenses subsequently incurred by such Indemnified Party or other
Indemnitee in connection with the analysis, defense or settlement of the Third
Party Claim.
14.4 Right to Participate in
Defense. Without limiting Section 14.2, any Indemnitee will be
entitled to participate in, but not control, the defense of such Third Party
Claim and to employ counsel of its choice for such purpose; provided, however, that such
employment will be at the Indemnitee’s own expense unless (i) the employment
thereof has been specifically authorized by the Indemnifying Party in writing,
or (ii) the Indemnifying Party has failed to assume the defense and employ
counsel in accordance with Section 14.2 (in which case the Indemnified Party
will control the defense).
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
14.5 Settlement. With
respect to any Losses relating solely to the payment of money damages in
connection with a Third Party Claim and that will not result in the Indemnitee’s
becoming subject to injunctive or other relief or otherwise adversely affect the
business of the Indemnitee in any manner other than by the payment of money
damages, and as to which the Indemnifying Party will have acknowledged in
writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying
Party will have the sole right to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of such Loss, on such terms as the
Indemnifying Party, in its sole discretion, will deem appropriate, and will
transfer to the Indemnified Party all amounts which said Indemnified Party will
be liable to pay prior to the entry of judgment. With respect to all
other Losses in connection with Third Party Claims, where the Indemnifying Party
has assumed the defense of the Third Party Claim in accordance with Section 14,
the Indemnifying Party will have authority to consent to the entry of any
judgment, enter into any settlement or otherwise dispose of such Loss provided
it obtains the prior written consent of the Indemnified Party (which consent
will be at the Indemnified Party’s sole and absolute discretion). The
Indemnifying Party will not be liable for any settlement or other disposition of
a Loss by an Indemnitee that is reached without the written consent of the
Indemnifying Party. Regardless of whether the Indemnifying Party
chooses to defend or prosecute any Third Party Claim, no Indemnitee will admit
any liability with respect to, or settle, compromise or discharge, any Third
Party Claim without the prior written consent of the Indemnifying
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
14.6 Cooperation. Regardless
of whether the Indemnifying Party chooses to defend or prosecute any Third Party
Claim, the Indemnified Party will, and will cause each other Indemnitee to,
cooperate in the defense or prosecution thereof and will furnish such records,
information and testimony, provide such witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be reasonably
requested in connection with such Third Party Claim. Such cooperation
will include access during normal business hours afforded to the Indemnifying
Party to, and reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making
Indemnitees and other employees and agents available on a mutually convenient
basis to provide additional information and explanation of any material provided
hereunder, and the Indemnifying Party will reimburse the Indemnified Party for
all its reasonable and documented out-of-pocket expenses in connection with such
cooperation.
14.7 Insurance. During
the Term, Micromet will have and maintain such types and amounts of liability
insurance as is normal and customary in the industry generally for parties
similarly situated, and will upon request provide MedImmune with a complete copy
of its policies of insurance in that regard, along with any amendments and
revisions thereto.
15.
|
Representations
and Warranties
|
15.1 Mutual Representations and
Warranties. Each Party hereby represents and warrants to the
other Party that, as of the Effective Date:
(a) Such
Party (i) has the power and authority to enter into this Agreement and perform
its obligations hereunder, and (ii) has taken all necessary action on its part
required to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder;
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(b) This
Agreement has been duly executed and delivered on behalf of such Party and
constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with its terms subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity, whether
enforceability is considered a proceeding at law or equity;
(c) The
execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (i) do not conflict with or violate any requirement of
applicable law or any provision of the articles of incorporation, bylaws or any
similar instrument of such Party in any material way, and (ii) do not conflict
with, violate, or breach or constitute a default or require any consent under,
any contractual obligation or court or administrative order by which such Party
is bound.
15.2 Additional Representations and
Warranties of Micromet. Micromet hereby represents and
warrants to MedImmune that Micromet is a corporation duly organized, validly
existing and in good standing under the laws of Germany, and has full corporate
power and authority and the legal right to own and operate its property and
assets and to carry on its business as it is now being conducted and as it is
contemplated to be conducted by this Agreement.
15.3 Additional Representations and
Warranties of MedImmune. MedImmune hereby represents and
warrants to Micromet that as of the Effective Date:
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(a) MedImmune
is a limited liability company duly organized, validly existing and in good
standing under the laws of Delaware, and has full power and authority and the
legal right to own and operate its property and assets and to carry on its
business as it is now being conducted and as it is contemplated to be conducted
by this Agreement;
(b) There
are no pending claims against MedImmune or to the actual knowledge of MedImmune
any threatened claims against MedImmune that Licensed Product infringes any
Patents of a Third Party;
(c) Exhibit
A includes all of the Patents made or generated in furtherance of and as a
direct result of employees, agents or independent contractors of MedImmune or
its Affiliates performing an activity pursuant to the Collaboration and License
Agreement; provided, however,
that any Patent within Collaboration Technology that is not included in
Exhibit A will be deemed automatically included therein and licensed hereunder
as of the Effective Date; and
(d) MedImmune
has the right to grant the licenses granted to Micromet in this Agreement, and
MedImmune has no actual knowledge that any of the Know-How within MedImmune
Process Technology has been misappropriated from a Third Party; and
(e) MedImmune
has transferred to Micromet the IND, orphan drug designations, any amendments
thereto, and all regulatory correspondence relating to the Product that are is
in the possession of MedImmune; provided, however, that
MedImmune will not be deemed to be in breach of this subsection (e) if it
provides any additional such regulatory filings or materials in its possession
promptly after receiving a request from Micromet identifying a specific
regulatory filing or document.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(f) As
of the Effective Date, MedImmune is not exclusively licensed under a license
agreement with a Third Party under any claims of a Patent that claim only a
process for manufacturing a BiTE Molecule which patent MedImmune has the right
to sublicense to Micromet without violating the terms of an agreement or
arrangement with such Third Party; provided, however, that MedImmune will not be
deemed to be in breach of this subsection (f) if MedImmune has such a license
and, upon request of Micromet, grants Micromet a sublicense with respect to
Licensed Product of the scope set forth under Section 6.1(a) of this Agreement,
but only to the extent permitted by and in accordance with the terms of such
license agreement and further provided that Micromet is obligated to make any
and all payments and royalties due to such Third Party as a result of granting
of and/or exercising rights granted under such sublicense, including but not
limited to milestones and royalties.
16.
|
Disclaimer;
Limitation of Liability
|
16.1 Disclaimer of Warranty. EXCEPT
FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, MEDIMMUNE AND MICROMET
MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN
FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND MEDIMMUNE AND MICROMET
EACH SPECIFICALLY DISCLAIM ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL,
EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO
THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES, AND MEDIMMUNE MAKES NO REPRESENTATIONS OR WARRANTIES
WITH RESPECT TO THE MANUFACTURING PROCESS OR MANUFACTURING PROCESS TECHNOLOGY
PROVIDED TO MICROMET.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
16.2 Limitation of
Liability. (a) IN NO EVENT WILL EITHER PARTY BE LIABLE FOR
LOST PROFITS, LOSS OF DATA, OR FOR ANY SPECIAL, INDIRECT, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY
AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF THIS
AGREEMENT. THE FOREGOING LIMITATIONS WILL NOT APPLY TO AN AWARD OF
ENHANCED DAMAGES AVAILABLE UNDER THE PATENT LAWS FOR WILLFUL PATENT INFRINGEMENT
AND WILL NOT LIMIT EITHER PARTY’S LIABILITY AND OBLIGATIONS TO THE OTHER PARTY
UNDER SECTIONS 10 AND 14.
(b) EXCEPT
AS PROVIDED IN SECTION 12.3(a) AND SUBJECT TO SECTION 16.2(a), IN NO EVENT WILL
MEDIMMUNE BE LIABLE TO MICROMET IN AN AMOUNT THAT EXCEEDS THE PAYMENTS RECEIVED
BY MEDIMMUNE FROM MICROMET UNDER THIS AGREEMENT.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
17.
|
Miscellaneous
|
17.1 Force
Majeure. Neither Party will be held liable or responsible to
the other Party or be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond the reasonable
control of the non-performing Party, including fires, floods, embargoes,
shortages, epidemics, quarantines, war, acts of war (whether war be declared or
not), insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority. The non-performing Party will notify the
other Party of such force majeure within [***]([***]) [***] after such
occurrence by giving written notice to the other Party stating the nature of the
event, its anticipated duration, and any action being taken to avoid or minimize
its effect. The suspension of performance will be of no greater scope
and no longer duration than is necessary and the non-performing Party will use
commercially reasonable efforts to remedy its inability to perform; provided, however, that in
the event the suspension of performance continues for [***]([***]) [***] after
the date of the occurrence, the Party not affected by such force majeure may
terminate this Agreement immediately upon written notice to the other
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
17.2 Assignment. Neither
Party will sell, transfer, assign, delegate, pledge or otherwise dispose of,
whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or duties under this Agreement without the prior
written consent of the other Party, which consent will not be withheld or
delayed unreasonably; provided, however, that
either Party may assign or transfer this Agreement or any of its rights or
obligations under this Agreement without the consent of the other Party (a) to
any Affiliate of such Party, or (b) to any Third Party with which it merges or
consolidates, or to which it transfers all or substantially all of its assets to
which this Agreement relates. The assigning Party (unless it is not
the surviving entity) will remain jointly and severally liable with the relevant
Affiliate or Third Party assignee under this Agreement, and the relevant
Affiliate assignee, Third Party assignee or surviving entity will assume in
writing all of the assigning Party’s obligations under this
Agreement. Any purported assignment or transfer in violation of this
section will be void ab initio and of no force or effect.
17.3
Severability. If
any provision of this Agreement is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations of either
Party under this Agreement will not be materially and adversely affected
thereby, (a) such provision will be fully severable, (b) this Agreement will be
construed and enforced as if such illegal, invalid or unenforceable provision
had never comprised a part of this Agreement, (c) the remaining provisions of
this Agreement will remain in full force and effect and will not be affected by
the illegal, invalid or unenforceable provision or by its severance from this
Agreement, and (d) in lieu of such illegal, invalid or unenforceable provision,
there will be added automatically as a part of this Agreement a legal, valid and
enforceable provision as similar in terms to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the
Parties.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
17.4 Governing
Law; Dispute Resolution.
(a) This
Agreement, and any claim, dispute, or controversy of whatever nature arising out
of or relating to this Agreement will be governed by and construed in accordance
with the laws of the State of New York, U.S.A., without giving effect to any
principles of choice of law that would require the application of the laws of a
different state or country.
(b) The
Parties will try to settle their differences amicably between
themselves. If any claim, dispute, or controversy of whatever nature
arising out of or relating to this Agreement, including the performance or
alleged non-performance of a Party of its obligations under this Agreement
arises between the Parties (each a “Dispute”), a Party may notify
the other Party in writing of such Dispute. If the Parties are unable
to resolve the Dispute within [***]([***]) [***] of receipt of the written
notice by the other Party, such Dispute will be referred to the Chief Executive
Officers of each of the Parties who will use their good faith efforts to resolve
the Dispute within [***]([***]) [***] after such referral.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(c) If
a Dispute is not resolved as provided in the preceding Section 17.4(b), whether
before or after termination of this Agreement, the Parties hereby agree to
resolve such Dispute by final and binding arbitration administered under the
rules of arbitration of JAMS by one (1) arbitrator appointed in accordance with
the said Rules, provided that upon request of either Party, three (3)
arbitrators will be appointed. If the Parties are unable to mutually
select such panel, the panel will be selected in accordance with the procedures
of JAMS. The decision and award rendered by the panel will be final
and binding. In any such arbitration, the arbitrators will not have
the right to modify the terms and conditions of this Agreement. As a
result, the rights and obligations of the Parties will be determined in
accordance with the terms and conditions of this Agreement and any decision or
award will be only in accordance with the terms and conditions of this
Agreement. The Parties will exert best efforts to have the decision
and award rendered within [***]([***]) [***] after the first to occur of (i)
notice of breach of this Agreement, which breach is a subject of the
arbitration, and (ii) a notice invoking this arbitration
provision. Judgment upon the award may be entered in any court having
jurisdiction thereof. Any arbitration pursuant to this section will
be held in Washington, D.C. or such other place as may be mutually agreed upon
in writing by the Parties. With respect to any Disputes arising in
connection with an alleged breach of a Party’s rights and obligations with
respect to confidential Know-How or Confidential Information received from the
other Party, the arbitrator will apply the discovery provisions of the Federal
Rules of Civil Procedure. This means that depositions may be taken
and full discovery may be obtained in any arbitration commenced under this
Section 17.4 with respect to such Disputes.
(d) Notwithstanding
the provisions of this Section 17.4, either Party will have the right to seek
temporary or permanent injunctive relief in any court of competent jurisdiction
as may be available to such Party under the laws and rules applicable in such
jurisdiction. Further, the provisions of this Section 17.4 will not
apply with respect to any claim of a Party that the other Party is infringing
any of its patents.
17.5 Notices. All
notices or other communications that are required or permitted hereunder will be
in writing and delivered personally, sent by facsimile (and promptly confirmed
by personal delivery or overnight courier as provided in this Agreement), or
sent by internationally-recognized overnight courier addressed as
follows:
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
If to
MedImmune, to:
MedImmune,
LLC.
Xxx
XxxXxxxxx Xxx
Xxxxxxxxxxxx,
XX 00000, XXX
Attention: Legal
Department
Facsimile: (000)
000-0000
If to
Micromet, to:
Micromet
AG
Xxxxxxxxxxxxxxxxx
0
00000
Xxxxxx
Xxxxxxx
Attention:
Chief Executive Officer
Facsimile:
xx00 00 000 000 000
With a
copy to:
0000
Xxxxxxxxx Xxxx.
Xxxxx
000
Xxxxxxxx,
XX 00000
Attention:
General Counsel
Facsimile:
000-000-0000
or to
such other address as the Party to whom notice is to be given may have furnished
to the other Party in writing in accordance with this Agreement. Any
such communication will be deemed to have been given (i) when delivered, if
personally delivered or sent by facsimile on a business day, and (ii) on the
second business day after dispatch, if sent by internationally-recognized
overnight courier. It is understood and agreed that this Section 17.5
is not intended to govern the day-to-day business communications necessary
between the Parties in performing their duties, in due course, under the terms
of this Agreement.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
17.6 Entire Agreement;
Modifications. This Agreement (including any Exhibits,
Schedules, or other attachments hereto, each of which is hereby incorporated by
reference herein) sets forth and constitutes the entire agreement and
understanding between the Parties with respect to the subject matter of this
Agreement and all prior agreements, understanding, promises and representations,
whether written or oral, with respect thereto are superseded by this Agreement
except to the extent expressly referenced herein, including the Collaboration
and License Agreement and the Related Agreements; provided, however, that no
agreement between the Parties executed contemporaneously with this Agreement
will be so superseded by this Agreement. Each Party confirms that it
is not relying on any representations or warranties of the other Party except as
specifically set forth in this Agreement. No amendment or
modification of this Agreement will be binding upon the Parties unless in
writing and duly executed by authorized representatives of both
Parties.
17.7 Relationship of the
Parties. It is expressly agreed that the relationship between
the Parties is and will be that of independent contractors, and that the
relationship between the Parties will not constitute a partnership, joint
venture or agency. Neither Party will have the authority to make any
statements, representations or commitments of any kind, or to take any action,
which will be binding on the other, without the prior written consent of the
other to do so. All persons employed by a Party will be employees of
such Party and not of the other Party and all costs and obligations incurred by
reason of any such employment will be for the account and expense of such
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
17.8 Waiver. Any term or
condition of this Agreement may be waived at any time by the Party that is
entitled to the benefit of such term or condition, but no such waiver will be
effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. The waiver by either
Party of any right under this Agreement or of claims based on the failure to
perform or a breach by the other Party will not be deemed a waiver of any other
right under this Agreement or of any other breach or failure by said other Party
whether of a similar nature or otherwise.
17.9 Counterparts. This
Agreement may be executed in counterparts, each of which will be deemed an
original, but all of which together will constitute one and the same
instrument.
17.10 No Benefit to Third
Parties. The representations, warranties, covenants and
agreements set forth in this Agreement are for the sole benefit of the Parties
hereto and their successors and permitted assigns, and they will not be
construed as conferring any rights on any other parties.
17.11 Further
Assurance. Each Party will duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents and instruments, as may be necessary or as the other Party
may reasonably request in connection with this Agreement or to carry out more
effectively the provisions and purposes, or to better assure and confirm unto
such other Party its rights and remedies under this Agreement.
17.12 English
Language. This Agreement has been written and executed in the
English language. Any translation into any other language will not be
an official version hereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version will
control.
*** 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
17.13 Non-Solicitation. During
the [***]([***])-[***] period following the Effective Date, Micromet will not
solicit the employment of any individual who, at the time of such solicitation
is an employee of MedImmune. For the avoidance of doubt, this Section
17.13 will not apply to general solicitations through public media, websites and
the like, and will not apply with respect to individuals who are first referred
to Micromet by third parties pursuant to an arrangement based on which such
third party is providing job placement services to such individual, or to
individuals who first approach Micromet regarding job
opportunities.
17.14 Construction. Except
where the context otherwise requires, wherever used, the singular will include
the plural, the plural the singular, the use of any gender will be applicable to
all genders, and the word “or” is used in the inclusive sense
(and/or). The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement. The term “including” as used herein means including,
without limiting the generality of any description preceding such
term. References to “Section” or “Sections” are references to the
numbered sections of this Agreement, unless expressly stated
otherwise.
[Remainder of this page is left blank
intentionally]
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
IN
WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by
their duly authorized representatives as of the date first above
written.
Micromet
AG
|
MedImmune,
LLC
|
|||
By:
|
/s/
Xxxx Xxxxxxxx
|
By:
|
/s/
Xxxxx Xxxxxxxxx
|
|
Name:
|
Xxxx
Xxxxxxxx
|
Name:
|
Xxxxx
Xxxxxxxxx
|
|
Title:
|
SVP,
Business Development
|
Title:
|
SVP,
Commercial, Corp. Dev.
|
|
By:
|
/s/
Xxxxxxx Xxxxxxxx
|
|||
Name:
|
Xxxxxxx
Xxxxxxxx
|
|||
Title:
|
CSO,
SVP R&D
|
[Signature
Page to the Termination and License Agreement]
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
A
Patents
within MedImmune Collaboration 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
B
MT103
Sequence
[***]
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
C
Services
Scope
of Work & Budget for Studies
A. [***]
[***] Protocol
|
Lot
#
|
Timing
|
Estimated
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
B. [***]
Description
of Study
|
Timing
|
Estimated
Costs
|
[***]
|
[***]
|
[***]
|
C. [***]
Description
of Study
|
Timing
|
Estimated
Costs
|
[***]
|
[***]
|
[***]
|
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
D
Clinical
Materials
[***]
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
E-1
Clinical
and Non-Clinical Documentation
Clinical
Documentation
·
|
[***]
|
·
|
[***]
|
Non-Clinical
Documentation
[***]
The
information and documentation listed above will be transferred to Micromet
within [***]([***]) [***] from the Effective Date.
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
E-2
Documents
and Material previously transferred to Micromet*
Clinical
Documentation
[***]
Regulatory
[***]
INN
[***]
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
E-3
Documents
to be transferred to Micromet
Document
Title
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[***]
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***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
[***]
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***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
[***]
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[***]
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***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
[***]
|
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|
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***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
[***]
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[***]
|
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
|
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
[***]
|
[***]
|
[***]
|
[***]
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[***]
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[***]
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***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
F
Form
of Confidentiality Agreement
This
Confidentiality (“Agreement”) is effective as of __________ __,
____(“Effective Date”), between MedImmune, LLC, having a place of business at
Xxx XxxXxxxxx Xxx, Xxxxxxxxxxxx, XX 00000 (“MedImmune”) and ________________,
having a place of business at
____________________________________ (“Company”). MedImmune
and Company may be referred to herein individually as a “Party” and collectively
as the “Parties.”
WHEREAS,
MedImmune and Micromet AG (“Micromet”) have entered into a Termination and
License Agreement, effective November 4, 2009, to terminate MedImmune’s rights
in MT103 (as defined below) and as such MedImmune has agreed to transfer its
manufacturing process for MT103 to a contract manufacturing
organization (“CMO”) on behalf on Micromet;
WHEREAS,
Company, on behalf of Micromet, has been selected as the CMO for
MT103;
WHEREAS,
MedImmune will provide MedImmune Property (as defined below) to Company solely
for the limited purpose of the technology transfer and establishment of a
manufacturing process and/or manufacture of MT103 Product at Company’s
facilities in its capacity as a CMO for Micromet (“Purpose”); and
WHEREAS,
MedImmune is willing to disclose the MedImmune Property on the condition that it
be maintained in strict secrecy and confidence and not be used for any purpose
other than the Purpose.
NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants
herein contained, the receipt and sufficiency of which are hereby acknowledged,
the Parties agree as follows.
1.
|
Definitions and
Interpretation.
|
1.1 Definitions. Capitalized
terms used in this Agreement shall have the meaning ascribed to them in this
Section 1.1 or as otherwise defined in the preamble or recitals above or
the text of this Agreement following this Section 1.1.
“MT103
Product” means MT103 alone or as part of a composition or formulation containing
MT103.
“MedImmune
Property" means any Know-How of MedImmune or any other information of MedImmune,
in each case provided to Company by or on behalf of MedImmune and/or by or on
behalf of Micromet.
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
“Know-How”
means (a) any scientific or technical information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever, 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, which Know-How includes but is not limited to fermentation processes,
recovery steps, process validation, product identity assays, in process control
assays, the formulation and/or components of Media Materials, relevant standard
operating procedures, and technical methods for assays and (b) any biological,
chemical, or physical materials, including but not limited to working cell banks
and Media Materials ("Materials").
“Media
Materials” shall mean the cell culture media and nutrient feeds used in the
Manufacturing Process.
“Manufacturing
Process” shall mean the process for manufacturing or producing MT103 alone or as
part of a composition or formulation.
“MT103”
shall mean the BiTE Product containing the BiTE Molecule with the amino acid
sequence set forth in Exhibit B of the Termination and License Agreement (as
referenced above). Such BiTE Molecule is currently known as
blinatumomab.
1.2 Other Interpretive
Matters.
(a) Unless
the context requires otherwise, (i) words in the singular include the
plural and vice versa, (ii) the term “includ(ing)(es)” means
“includ(ing)(es) without limitation,” and (iii) the terms “herein,”
“hereof,” “hereunder” and words of similar import shall mean references to this
Agreement as a whole and not to any individual Section or portion of this
Agreement. All references to “day” or “days” shall mean calendar days
unless otherwise noted.
(b) No
provision of this Agreement will be interpreted in favor of, or against, either
of the Parties by reason of the extent to which any such Party or its counsel
participated in the drafting thereof or by reason of the extent to which any
such provision is inconsistent with any prior draft of this Agreement or such
provision.
(c) The
captions to the several Articles and Sections hereof are not a part of the
Agreement, but are merely for convenience to assist in locating and reading the
several Articles and Sections of this Agreement.
2.
|
Duties.
|
2.1 Disclosure and Use
Restrictions. Except as expressly provided herein, Company
agrees that without limitation as to time and subject to Sections 3.1 and 3.2,
Company and its Affiliates will keep completely confidential and will not
publish or otherwise disclose any MedImmune Property and/or provide a third
party with MedImmune Property and will use MedImmune Property including but not
limited to Media Materials only for the Purpose.
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
2.2 Restrictions Regarding
Physical Prototypes. Company shall not sequence, reverse
engineer, copy, dissemble, obtain the recipe or components or otherwise attempt
to reconstruct any physical embodiments of the Media
Materials. Notwithstanding anything to the contrary, in the event
Company, its Affiliates, subcontractors, or licensees ascertains or receives the
recipe of any Media Material through no fault of its own, such recipe will still
be considered Confidential Information herein and Company will inform and cause
its Affiliates, subcontractors, or licensees to promptly inform MedImmune of
such event and destroy such information.
3.
|
Exceptions and Other
Matters.
|
3.1 Exclusions Notwithstanding
the foregoing, any MedImmune Property will not be deemed MedImmune Property for
purposes of this Agreement if such MedImmune Property:
|
(1)
|
was
already known or available to Company, other than under an obligation of
confidentiality or non-use, at the time of disclosure to
Company;
|
|
(2)
|
was
generally available or known to parties reasonably skilled in the field to
which such information pertains, or was otherwise part of the public
domain, at the time of its disclosure to the
Company;
|
|
(3)
|
became
generally available or known to parties reasonably skilled in the field to
which such information pertains, or otherwise became part of the public
domain, after its disclosure to the Company through no fault of or breach
of its obligations under Article 2 by the
Company;
|
|
(4)
|
was
disclosed to the Company, other than under an obligation of
confidentiality or non-use, by a Third Party who had no obligation to
MedImmune not to disclose such information to others;
or
|
|
(5)
|
was
independently discovered or developed by the Company or its Affiliates, as
evidenced by their written records, without the use of, and by personnel
who had no access to MedImmune
Property.
|
3.2 Authorized
Disclosures. Company may disclose MedImmune Property to the
extent that such disclosure is:
|
(1)
|
made
in response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided, however, that
the Company will first have given notice to MedImmune and given MedImmune
a reasonable opportunity to quash such order and to obtain a protective
order requiring that the MedImmune Property and documents that are the
subject of such order be held in confidence by such court or governmental
or regulatory body or, if disclosed, be used only for the purposes for
which the order was issued; and provided, further, that
if a disclosure order is not quashed or a protective order is not
obtained, the MedImmune Property disclosed in response to such court or
governmental order will be limited to that information which is legally
required to be disclosed in response to such court or governmental order;
or
|
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
|
(2)
|
otherwise
required by law, rule, or regulation; provided, however, that
the Company will provide MedImmune with notice of such disclosure in
advance thereof to the extent
practicable.
|
3.3 No Representation or
Warranty by MedImmune. MedImmune makes no express or implied
representation or warranty as to the accuracy, completeness or utility of the
MedImmune Property.
3.4 Ownership;
Return/Destruction. All MedImmune Property is and shall remain
the sole and exclusive property of MedImmune. Company agrees that
upon its termination as a CMO by Micromet related to the Purpose, within twenty
(20) days thereafter, Company shall: (a) cease any use of the
Materials, including any Media Materials, and all copies of the foregoing or any
portion thereof, in whatever form or medium stored, and (b) transfer all
MedImmune Property, including all documents, samples, summaries, extracts,
records or other materials that contain any of the MedImmune Property, in
whatever form or medium stored, to Micromet or its designee, and such designee
shall be subject to legally
binding nondisclosure and use restrictions that are at least as restrictive as
the terms of this Agreement, and (c) upon completion of such transfer,
certify in writing that such transfer is complete.
3.5 No License
Implied. This Agreement shall not be construed to grant to
Company any license, expressed or implied, or other rights with respect to the
MedImmune Property.
3.6 Indemnification by
Company. Company will indemnify MedImmune and its Affiliates,
and their respective directors, officers, and employees (each, a “MedImmune
Indemnitee”), and defend and save each of them harmless from and against any and
all losses, damages, liabilities, costs and expenses (including reasonable
attorneys’ fees and expenses) in connection with any and all liability suits,
investigations, claims or demands (collectively, “Losses”) arising from or
occurring as a result of any claim or lawsuit by a third party against a
MedImmune Indemnitee, to the extent caused by or arising out of: (a) negligence
or willful misconduct on the part of Company, or its Affiliates, representatives
or agents in performing any activity related to the Purpose, or (b) the
manufacture or production of MT103 Product by Company, its Affiliates,
representatives or agents; or (c) the use of MedImmune Property by or on behalf
of Company or its Affiliates, agents or representatives; in each case, excluding
any Losses to the extent that such Losses arise out of the negligence or willful
misconduct of a MedImmune Indemnitee.
3.7 Use of
Name. Neither Party will make public use of the other Party’s
name except (a) in connection with announcements and other permitted disclosures
relating to this Agreement and the activities contemplated hereby, (b) as
required by applicable law, rule, or regulation, and (c) otherwise as agreed in
writing by such other 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
4.
|
Termination.
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4.1 Termination. MedImmune
may terminate this Agreement for any or no reason upon thirty (30) days
advance written notice to Company. Expiration or termination of this
Agreement for any reason shall be without prejudice to any rights that shall
have accrued to the benefit of a Party or the Parties prior to such expiration
or termination, and shall not relieve the Parties of any obligations that have
accrued to the other Party prior to such expiration or termination.
4.2 Survival. Company’s
obligations, agents or representations under Articles 2, 3, and 5 and this
Section 4.2 shall survive termination of this Agreement.
5.
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Miscellaneous.
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5.1 Assignment. Company
will not sell, transfer, assign, delegate, pledge or otherwise dispose of,
whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or duties under this Agreement without the prior
written consent of MedImmune, which consent will not be withheld or delayed
unreasonably; provided,
however, that Company may assign or transfer this Agreement or any of its
rights or obligations under this Agreement without the consent of MedImmune (a)
to any Affiliate of such Party, or (b) to any third party with which it merges
or consolidates, or to which it transfers all or substantially all of its assets
to which this Agreement relates. MedImmune may assign this Agreement
without the consent of Company by written notice to Company. The
assigning Party (unless it is not the surviving entity) will remain jointly and
severally liable with the relevant Affiliate or third party assignee under this
Agreement, and the relevant Affiliate assignee, third party assignee or
surviving entity will assume in writing all of the assigning Party’s obligations
under this Agreement. Any purported assignment or transfer in
violation of this section will be void ab initio and of no force or
effect.
5.2 Applicable
Law. This Agreement, and any claim, dispute, or controversy of
whatever nature arising out of or relating to this Agreement will be governed by
and construed in accordance with the laws of the State of New York, U.S.A.,
without giving effect to any principles of choice of law that would require the
application of the laws of a different state or country.
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
5.3 Compliance with Laws; Export
Controls. Company shall comply with all applicable laws, rules
and regulations arising in connection with this Agreement and its use of the
MedImmune Property. Without limiting the foregoing, this Agreement is
made subject to any restrictions under the export control laws, rules and
regulations concerning the export of products, materials or technical
information either from the United States of America or to a foreign
national within the United States of America (e.g., a “deemed export”
applying to transfers solely within the United States of America) which may be
imposed upon or related to Company from time to time by the government of the
United States of America. In connection therewith, Company
agrees that it will not export, directly or indirectly, technical information
provided or arising under this Agreement or any materials or products using or
embodying such technical information to any country or foreign national for
which the United States government or any agency thereof at the time of export
requires an export license or other governmental approval, without first
obtaining the written consent to do so from the Department of Commerce or other
agency of the United States government when required by an applicable statute or
regulation.
5.4 Notices. Each
notice required or permitted hereunder shall be in writing and sufficient if
delivered personally, sent by a nationally-recognized overnight courier or sent
by registered or certified mail, postage prepaid, return receipt requested, to
the Parties at the addresses indicated in the introductory paragraph of this
Agreement, to the attention of the signatories below. Either Party
may change its address by giving the other party written notice, delivered in
accordance with this Section 5.4.
5.5 Waivers and Amendments;
Preservation of Remedies. This Agreement may be amended,
modified, superseded, canceled, renewed or extended, and the terms and
conditions hereof may be waived, only by a written instrument signed by the
Parties or, in the case of a waiver, the Party waiving compliance. No
delay on the part of any Party in exercising any right, power or privilege
hereunder shall operate as a waiver thereof, nor shall any waiver on the part of
any Party of any right, power or privilege hereunder, nor any single or partial
exercise of any right, power or privilege hereunder, preclude any other or other
exercise thereof hereunder. The rights and remedies herein provided
are cumulative and are not exclusive of any rights or remedies which any Party
may otherwise have at law or in equity.
5.6 Injunctive
Relief. Company acknowledges that: (a) the
covenants and the restrictions contained in this Agreement are an inducement to
MedImmune to enter into this Agreement and are necessary and required for the
protection of MedImmune; (b) such covenants and restrictions relate to
matters that are of a special, unique and extraordinary character that give each
of such covenants a special, unique and extraordinary value; and (c) a
breach of any of such covenants or restrictions may result in irreparable harm
and damages to MedImmune in an amount difficult to ascertain and which cannot be
adequately compensated by a monetary award. Accordingly, in addition
to any of the relief to which MedImmune shall be entitled under this Agreement,
at law or in equity, MedImmune shall be entitled to seek temporary and permanent
injunctive relief from any breach or threatened breach of such covenants or
restrictions without proof of actual damages that have been or may be caused to
MedImmune by such breach or threatened breach. In the event an action
for injunctive relief is brought by MedImmune, Company waives any right to
require MedImmune to post any bond or other security with the court in
connection therewith.
5.7 Independent
Relationship. Company and MedImmune are independent
contractors. The relationship between the two Parties does not
constitute a partnership, joint venture or agency and shall not be construed as
such. Neither Company nor MedImmune has any authority to make any
statements, representations or commitments of any kind, or to take any action
that is binding on the other 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
5.8 Entire
Agreement. This Agreement constitutes the entire understanding
of the Parties with respect to the subject matter hereof. All express
or implied agreements and understandings, either oral or written, with regard to
the services to be performed hereunder are superseded by the terms of this
Agreement.
5.9 Severability. If
any one or more provisions of this Agreement is held invalid, illegal or
unenforceable in any respect by a court having competent jurisdiction, the
validity, legality and enforceability of this Agreement and the remaining
provisions contained herein shall not in any way be affected or impaired
thereby, unless the absence of the invalidated provision(s) adversely affects
the substantive rights of the Parties. The Parties shall in such
instance use their best efforts to replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s) which,
insofar as practical, implement the purposes of this
Agreement.
5.10 Counterparts. This
Agreement may be executed and delivered by any means and in any number of
counterparts, each of which shall be an original as against either Party whose
signature appears thereon, but all of which taken together shall constitute but
one and the same instrument.
{
Signature page follows. }
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
IN
WITNESS WHEREOF, the Parties have executed this Agreement to be effective as of
the Effective Date.
MEDIMMUNE,
LLC
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By:
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Name:
|
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Title:
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[NAME
OF COMPANY]
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By:
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Name:
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Title:
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***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
G
Press
Release
Micromet
Buys Out MedImmune’s Remaining Rights to Blinatumomab
BETHESDA, MD,
<<Date>>— Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical
company developing novel, proprietary antibodies for the treatment of cancer,
inflammation and autoimmune diseases, today announced that it has signed an
agreement with MedImmune, LLC to buy out MedImmune’s rights to blinatumomab in
North America, and to terminate the collaboration agreement signed in 2003 under
which MedImmune had been granted the right to develop and commericalize
blinatumomab in North America. As a result of this transaction,
Micromet now controls global rights to develop and commercialize
blinatumomab.
In March
2009, MedImmune returned the North American rights to develop and commercialize
blinatumumab to Micromet, but retained an option to reacquire the right to
commercialize blinatumomab in North America. Under the terms of the termination
agreement, Micromet has now regained MedImmune’s remaining rights relating to
blinatumomab as well as any other BiTE antibodies binding to antigens relevant
for hematological cancers that had been reserved for MedImmune under the
terminated agreement. Micromet will make upfront, milestone, and
royalty payments to MedImmune related to the development and North American net
sales of blinatumomab.
“The
advancement of blinatumomab in the clinic is the top priority for Micromet,”
said Micromet CEO Xxxxxxxxx Xxxx. “With complete control over global development
and commercialization of blinatumomab, Micromet can develop an integrated
clinical and regulatory strategy across multiple commercial territories,
starting with the first pivotal study that we expect to initiate in
2010.”
Blinatumomab
is a novel therapeutic antibody that activates a patient's T cells to seek out
and destroy lymphoma and leukemia cells. At the recent meeting of the European
Hematological Association (EHA), Micromet announced that blinatumomab had
achieved its primary endpoint in an ongoing phase 2 clinical trial in ALL
patients. Micromet intends to initiate a pivotal trial of blinatumomab in ALL
patients next year.
About
Micromet, Inc.
Micromet,
Inc. is a biopharmaceutical company developing novel, proprietary antibodies for
the treatment of cancer, inflammation and autoimmune diseases. Its product
development pipeline includes novel antibodies generated with its proprietary
BiTE® antibody platform, as well as conventional monoclonal antibodies. Two of
Micromet’s BiTE antibodies and three of its conventional antibodies are
currently in clinical trials. Micromet's preclinical product pipeline
includes several novel BiTE antibodies generated with its proprietary BiTE
antibody platform technology. Micromet’s collaboration partners
include Bayer Schering Pharma, Merck Serono, MedImmune and Nycomed.
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Forward-Looking
Statements
This
release contains certain forward-looking statements that involve risks and
uncertainties that could cause actual results to be materially different from
historical results or from any future results expressed or implied by such
forward-looking statements. These forward-looking statements include statements
regarding the development and commercialization of blinatumomab, including the
conduct and timing of future clinical trials involving this product candidate.
You are urged to consider statements that include the words "ongoing," "may,"
"will," "believes," "potential," "expects," "plans," "anticipates," "intends,"
or the negative of those words or other similar words to be uncertain and
forward-looking. Factors that may cause actual results to differ materially from
any future results expressed or implied by any forward-looking statements
include the risk that blinatumomab does not demonstrate safety and/or efficacy
in future clinical trials, the risk that we will not obtain approval to market
blinatumomab and the risks associated with reliance on outside financing to meet
capital requirements. These factors and others are more fully discussed in
Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2009, filed with the SEC on August 6, 2009, as well as other filings by the
company with the SEC.
# #
#
US
Media:
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European
Media:
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Xxxxxx
xxxXxxxx/Xxxxx Xxxxx
|
Xxxxxx
Xxxx
|
(000)-000-0000
|
x00
(00) 0000 0000
|
xxxxxxxx@xxxxxxxx-xx.xxx
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xxxxxx@xxxxxxxx.xxx
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US
Investors:
|
European
Investors:
|
Xxxxx
Xxxxxx
|
Xxxx-Xxxxxx
Xxxx
|
x00
(00) 0000 0000
|
|
xxxxx@xxxxxxxx.xxx
|
xxxx@xxxxxxxx.xxx
|
***
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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
H
Media
Materials
Cell
Culture Media and Nutrient Feeds
Quantity:
Media and nutrient feed sufficient for [***]
Price:
Amount corresponding to purchase price paid by MedImmune to the Media
Suppliers
Delivery
Term: FCA (Incoterms 2000)
Specifications:
As used for the manufacture of the Clinical Materials
***
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.