COLLABORATION AND LICENSE AGREEMENT
***Text Omitted and Filed
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Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
This
Collaboration and License Agreement (the “Agreement”) is made and
entered into effect as of October 28, 2009 (the “Effective Date”), by and
between Micromet
AG, having its principal place of business at Xxxxxxxxxxxxxxxxx 0, 00000
Xxxxxx, Xxxxxxx (“Micromet”), and sanofi-aventis,
having its principal place of business at 000, xxxxxx xx Xxxxxx, 00000 Xxxxx
Xxxxx 00, Xxxxxx (“Sanofi”). Micromet
and Sanofi each may be referred to herein individually as a “Party,” or collectively as the
“Parties.”
Recitals
A. Micromet
has developed a proprietary platform for the discovery, research, and
development of BiTE®
antibodies, which may have applications in the treatment of cancer and other
diseases.
B. Sanofi
is a global pharmaceutical company with experience in the development and
commercialization of pharmaceutical products.
C. Micromet
and Sanofi desire to collaborate on the research and development of one or more
products comprising a BiTE antibody binding to a specific target, and to have
Sanofi further develop, manufacture and commercialize such products on a
worldwide basis.
In
consideration of the foregoing premises and the mutual promises and covenants
contained herein and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereby agree as
follows:
Agreement
1.
|
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
“Additional Third Party IP”
has the meaning as defined in Section 8.5.2.
1.2
“Affiliate” means an 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 an
entity, whether through the ownership of voting securities, contract rights,
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 an entity.
1.3
“Alliance Manager” has the
meaning as defined in Section 2.3.1.
1.4
“
[***] Product” has the meaning defined
in Section 7.9.1.
***
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.
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Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.5
“Antibody” means a molecule
comprising two or more immunoglobulin variable domains or parts of such
domains.
1.6
“Applicable Law” means the
laws, rules, and regulations, including any statutes, rules, regulations,
guidelines, or other requirements (including Good Manufacturing Practices (GMP),
Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), collectively
referred to as “GxP”),
that may be in effect from time to time and apply to the development,
manufacture, registration, and marketing of a Product in the countries of the
Territory, including any such statutes, rules, regulations, guidelines, or other
requirements of the FDA or the EMEA.
1.7
“
[***] Product” means with respect to
a Product in a given [***] , any [***] product
that (a) is [***] in such [***] by
a [***] ; and (b) has [***] (based upon then-current
Applicable Laws governing [***] of [***] ) as
a [***] or [***] based in whole or in part
upon [***] for a [***] or [***] with
a [***] .
1.8
“BiTE
Antibody” means any bi-specific, single-chain Antibody binding to
the [***] of T cells.
1.9
“BLA” means a Biologics License
Application, supplemental Biologics License Application, or similar application
filed or to be filed with the FDA, or a comparable application in jurisdictions
outside the United States of America, including a marketing approval application
filed or to be filed with the EMEA.
1.10
“Breaching Party” has the meaning as
defined in Section 12.2.1.
1.11
“Business
Day” means any weekday that is not a legal holiday in New York, New York,
Paris, France, or Munich, Germany and is not a day on which banking institutions
in any of those cities are required by law or regulation to be
closed.
1.12
“Calendar Quarter” means any
one of the four three-month time periods in any calendar year commencing on
January 1, April 1, July 1 and October 1 of such year.
1.13
“Change of Control” means with respect to
any Party (the “Acquired
Entity”) (a) any sale, exchange, transfer, issuance to, or acquisition,
whether in one transaction or a series of related transactions, by one or more
Third Parties of shares representing more than fifty percent (50%) of the
aggregate ordinary voting power entitled to vote for the election of directors
represented by the issued and outstanding stock of the Acquired Entity or any
Affiliate that directly or indirectly controls the Acquired Entity, whether such
sale, exchange, transfer, issuance or acquisition is made directly or
indirectly, by merger or otherwise, or beneficially or of record, but excluding
the issuance of shares in a financing transaction; (b) a merger or consolidation
under applicable law of the Acquired Entity with a Third Party in which the
shareholders of the Acquired Entity or any Affiliate that directly or indirectly
controls the Acquired Entity immediately prior to such merger or consolidation
do not continue to hold immediately following the closing of such merger or
consolidation at least fifty percent (50%) of the aggregate ordinary voting
power entitled to vote for the election of directors represented by the issued
and outstanding stock of the entity surviving or resulting from such
consolidation; or (c) a sale or other disposition of all or substantially all of
the assets of the Acquired Entity to one (1) or more Third Parties in one
transaction or a series of related transactions.
***
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
1.14 “Clinical Supply Requirements”
means the quantities of BiTE Antibodies which are required by a Party or the
Parties for the development of a Product under this Agreement, including,
without limitation, the conduct of research, pre-clinical studies and clinical
trials in connection with the Development Plan.
1.15 “Co-Chair” has the meaning as
defined in Section 2.1.1.
1.16 “Collaboration Product Patent”
means any Patent within the Collaboration Technology that (i)
is [***] or [***] for the development,
manufacture or Commercialization of a Product; and (ii) is not [***]
or [***] for the development, manufacture or
commercialization of a [***] [***] to a
[***] that is not a [***] .
1.17 “Collaboration Target” means
the whole of, or fragments and [***] of, [***]
other [***] identified by
the [***] entry name [***] and
accession number [***] with the amino acid sequence as set
out in Exhibit
A, or any [***] of such target.
1.18 “Collaboration Technology”
means any Patent or Know-How that is conceived or generated solely or jointly by
any employee, agent or Service Provider of one or both Parties in the course of
performing activities under this Agreement.
1.19 “Commercialization” means the
pre-marketing activities conducted for a Product prior to obtaining Marketing
Approval, the manufacture for commercial sale, and the marketing, promotion,
advertising, selling and distribution of a Product after Marketing Approval has
been obtained. The term “Commercialize” has a
correlative meaning.
1.20
“Commercially Reasonable
Efforts” means the carrying out of obligations or tasks by a Party in an
ongoing and sustained manner using a level of efforts in good faith consistent
with the exercise of prudent scientific and business judgment, as applied by
such Party to products or research or development projects owned by it of
similar scientific and commercial potential. Commercially Reasonable
Efforts will take into account the stage of development or commercialization,
market potential and market size, the product life cycle, the risk of
development or Commercialization of the Product, the cost effectiveness of
efforts or resources, the competitiveness of alternative products that are or
are expected to be in the marketplace, the scope and duration of patent rights
or other proprietary rights related to the Product, the profitability of the
Product and alternative products and other relevant commercial
factors.
1.21 “Confidential Information” has the meaning as
defined in Section 10.1.
1.22 “Control” means, with respect
to a Party and any Patent, Know-How, or other intellectual property right, that
a Party owns or has a license to such Patent, Know-How or intellectual property
right and has the ability to grant to the other Party a license or a sublicense
(as applicable) to such Patent, Know-How or intellectual property right on the
terms and conditions set forth herein without violating the terms of any
agreement or other arrangement with any Third Party existing at the time such
Party would be required hereunder to grant to the other Party such access,
license or sublicense. The term “Controlled” 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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Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.23 “Development Plan” means the
plan for the research and development of a Product, as may be amended in
accordance with Section 3.1.2.
1.24 “Disclosing Party” has the meaning as
defined in Section 10.1.
1.25 “Dispute” has the meaning as
defined in Section 17.4.2.
1.26 “EMEA” means the European
Medicines Agency, or any successor agency thereto.
1.27 “Executive Officer” means (a)
in the case of Micromet, the [***] of Micromet; and (b) in
the case of Sanofi (i) prior to the Marketing Approval of a Product,
Sanofi’s [***] or the [***] of
Sanofi’s [***] ; and (ii) after the first Marketing Approval of a
Product, Sanofi’s [***] .
1.28 “FDA” means the United States
Food and Drug Administration, or any successor agency thereto.
1.29 “First Commercial Sale” means
the first sale to a Third Party of a Product in a country after approval of a
BLA has been obtained for such country.
1.30 “Field” means
the [***] and [***] of [***]
and [***] and [***] ,
including [***] and [***] .
1.31 “FTE” means the equivalent of a
total of [***] hours per year of work carried out by a
qualified employee a Party in connection with the execution of the Development
Plan. In the case that any personnel of a Party who works partially
on the execution of the Development Plan and partially on other work, then the
full-time equivalent to be attributed to such individual’s work hereunder will
be equal to the percentage of such individual’s total work time that such
individual spent working on the execution of the Development
Plan. FTE work will not include the work of [***]
or [***] , except to the extent included in the FTE
Rate.
1.32 “Governmental Authority” means
any supranational, national, federal, state, local, municipal,
quasi-governmental or other authority of any nature (including any governmental
division, subdivision, department, agency, bureau, branch, office, commission,
council, court or other tribunal) exercising executive, legislative or judicial
governmental powers.
1.33 “ICC” has the meaning as
defined in Section 17.4.3.
1.34 “IND” means an Investigational
New Drug Application filed or to be filed with the FDA, and the equivalent
application in jurisdictions outside the United States of America, including
“Investigational Medicinal Product Dossier” filed or to be filed with the
EMEA.
***
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
1.35 “Indemnification Claim Notice”
has the meaning as defined in Section 14.3.
1.36 “Indemnified Party” has the meaning as
defined in Section 14.3.
1.37 “Indemnifying Party” has the meaning as
defined in Section 14.3.
1.38 “Indemnitees” has the meaning as
defined in Section 14.3.
1.39 “Indication” means
a [***] of an [***] or any [***]
or [***] (or [***] thereof) of
a [***] of a [***] for which a [***] may
be [***] ( [***] or [***] , or [***]
or [***] ).
1.40 “Initial Development Plan” has the meaning as
defined in Section 3.1.2.
1.41
“Joint Collaboration
Technology” means any Collaboration Technology or any other Patent or
Know-How conceived
or generated jointly in the performance of this Agreement by employees, agents,
or Service Providers of both Parties or their respective
Affiliates.
1.42 “ [***] ” means the research
and development of a Product until the later of (a) the receipt of the
final [***] , or (b) the completion of all [***]
or [***] to be performed
by [***] pursuant to the [***] for
such Product.
1.43 “JPT” has the meaning as
defined in Section 2.2.1.
1.44 “JPT Leader” has the meaning as
defined in Section 2.2.1.
1.45 “JSC” has the meaning as
defined in Section 2.1.1.
1.46 “Know-How” means (a) any
scientific or technical information, results and data of any type whatsoever, in
any tangible or intangible form whatsoever, that is not in the public domain or
otherwise publicly known, including databases, practices, methods, techniques,
specifications, formulations, formulae, protein sequences, DNA sequences,
knowledge, know-how, skill, experience, test data including pharmacological,
medicinal chemistry, biological, chemical, biochemical, toxicological and
clinical test data, analytical and quality control data, stability data, studies
and procedures, and manufacturing process and development information, results
and data, and (b) any biological, chemical, or physical materials that are not
in the public domain or otherwise available to the public; all to the extent not
claimed or disclosed in a Patent.
1.47 “Lead Candidate” means a BiTE
Antibody binding to the Collaboration Target which has been designated as a Lead
Candidate by the JSC according to Sections 2.1.2 and 3.2.1.
1.48 “Licensed Technology” means
the [***] Technology, [***] Technology, [***] Technology,
and [***] rights and interest
in [***] Technology, and
any [***] Technology
or [***] Technology to the extent included in Licensed
Technology pursuant to Sections 7.3 or 7.4.
1.49 “Losses” has the meaning as
defined in Section 14.1.
***
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
1.50 “Major Market” means each of
the [***] , the [***] , [***]
, [***] , [***] , [***] and [***]
..
1.51 “Major Pharmaceutical
Company” has
the meaning defined in Section 7.5.
1.52 “Marketing Approval” means the
approval of a BLA, and any [***] and [***] to
the extent required by Applicable Law prior to the sale of a Product in a
country.
1.53 “ [***] Clinical Supply
Cost” means (a) the [***] incurred by [***] Micromet
for [***] and for having [***] and [***]
for [***] under the Development Plan, (b) the [***]
incurred by [***] for [***]
and [***] of such [***] for activities
contemplated under the Development Plan and (c) any [***]
or [***] actually paid with respect to
the [***] or [***] of [***]
..
1.54 “ [***] Technology”
means any [***] conceived or generated solely by
employees, agents or Service Providers of [***] or its
Affiliates.
1.55
“
[***] Collaborator” means any Third Party developing or
commercializing a product containing or comprising
a [***] alone or in collaboration
with [***] under a license to Patents Controlled
by [***] .
1.56 “ [***] Technology”
means any Patent or Know-How that (a) is conceived or generated by employees,
agents or Service Providers of a [***] or its Affiliates, either
solely or jointly with employees, agents or Service Providers
of [***] or its Affiliates, (b) is Controlled by [***] ,
and (c) is [***] or [***] for the [***]
or [***] of a [***] .
1.57 “ [***] Development
Expenses” means those costs and expenses incurred by [***]
after the [***] directly in connection with the [***] of
a [***] in accordance with this Agreement and included in
the [***] , limited to the following:
(a)
[***] associated with the [***] of any [***] performed
by [***] or by a [***] on behalf
of [***] in accordance with the Development Plan (and for
clarity are not otherwise included as part of the [***]
);
(b)
[***] ;
(c)
[***] ; and
(d) any
other costs or expenses [***] and included in the Development
Plan.
1.58 “ [***] FTE Costs” means, for
all [***] performed by [***] in accordance with
the [***] , the product of (a) the number of FTEs used
by [***] for such development activity as set forth in
the [***] and (b) the [***] FTE Rate. For the avoidance of
doubt, the activity of contract personnel will be charged as Out-of-Pocket
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
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Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.59 “ [***] FTE Rate” means €
[***] per FTE, which amount is [***] and
includes without limitation, for each FTE, [***] and [***]
, and [***] of [***] and [***] .
1.60 “Micromet Indemnitee” has the meaning as
defined in Section 14.1.
1.61 “ [***] Technology”
means any Patent or Know-How that (a) is [***] Technology
or [***] Technology, (b) is owned by [***]
after the Effective Date but prior to a [***] of [***] ,
and (c) is [***] or [***] for the [***]
or [***] of a [***] .
1.62 “ [***] Technology”
means any Patent or Know-How that (a) is Controlled by [***] through
a license from a Third Party to [***] as of the Effective
Date, and (b) is [***] or [***] for the [***]
or [***] of a [***] , including the Patents Controlled
by [***] pursuant to the [***] listed in Exhibit
D.
1.63 “ [***] Technology”
means any Patent or Know-How that (a) is Controlled
by [***] through ownership as of the Effective Date, and
(b) is [***] or [***] for the [***]
or [***] of a [***] , including the Patents
listed on Exhibit
C.
1.64 “ [***] Product” means any product
comprising a [***] binding to a target other than
the [***] .
1.65 “Net Sales” means the gross
amount invoiced or otherwise collected by or on behalf of Sanofi or its
Affiliates or sublicensees for arm’s length sales of Products to Third Party
purchasers, less the following deductions in each case to the extent included in
such invoice or otherwise actually allowed or incurred with respect to such
sales, determined in accordance with IAS/IFRS (or GAAP for the US) consistently
applied:
(a) normal
and customary trade, cash, quantity and free-goods allowances granted and taken
directly with respect to sales of such Products;
(b) amounts
repaid or credited by reason of returned products, including for defects,
rejections, recalls, returns and billing errors;
(c) chargebacks
and other amounts paid on sale of Products;
(d) Third
Party cash rebates and chargebacks related to sales of Products, to the extent
allowed;
(e) retroactive
price reductions that are actually allowed or granted;
(f) compulsory
refunds, credits and rebates granted to Third Parties for the sale of Products,
accrued, paid or deducted pursuant to agreements (including, but not limited to,
managed care agreements) or government regulations;
(g) freight,
postage, shipment and costs (or wholesale fees in lieu of those costs) and
customs duties incurred in importing or exporting Products that are separately
identified on the invoice or other documentation;
***
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
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Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(h) sales
taxes, excess duties, or other consumption taxes and compulsory payments to
Governmental Authorities or other governmental charges imposed on the sale of
Products, which are separately identified on the invoice or other documentation,
but specifically excluding taxes based upon net income of a Party;
(i) bad
debts relating to sales of Products that are actually written off by Sanofi in
accordance with IAS/IFRS (or GAAP for the US), consistently applied, during the
applicable royalty calculation period; and
(j) as
agreed by the Parties in writing (in each Party’s sole discretion), any other
specifically identifiable costs or charges included in the gross invoiced sales
price of such Product falling within categories substantially equivalent to
those listed above and ultimately credited to customers or a Governmental
Authority or agency thereof.
Net Sales
in currency other than Euro will be translated into Euro according to the
provisions of Section 9.4 of this Agreement. Sales between the
Parties, or between the Parties and their Affiliates or sublicensees, for resale
to Third Parties, will be disregarded for purposes of calculating Net Sales;
provided that the subsequent sale to a Third Party is included in Net Sales. Any
of the items set forth above that would otherwise be deducted from the invoice
price in the calculation of Net Sales but which are separately charged to, and
paid by Third Parties will not be deducted from the invoice price in the
calculation of Net Sales. In the case of any sale of a Product for consideration
other than cash, such as barter or countertrade, Net Sales will be calculated on
the fair market value of the consideration received as agreed by the
Parties.
A sale of
a Product is deemed to occur upon invoicing. If any discounts or
other deductions are made in connection with sales of the Product that are
bundled or sold together with other products of Sanofi, its Affiliates or
sublicensees, in no event will the discount applied to the Product exceed the
discount applied to other products of Sanofi, its Affiliates or sublicensees in
such arrangement based upon the respective list prices of the Product and such
other products prior to applying the discount.
Solely
for purposes of calculating Net Sales, if Sanofi or its Affiliate or sublicensee
sells Products in the form of a combination product containing any
Product and one or more active ingredients (whether combined in a single
formulation or package, as applicable, or formulated or packaged separately but
sold together for a single price in a manner consistent with the terms of this
Agreement) (a "Combination
Product"), then Net Sales, for purposes of determining royalty payments
on such Combination Product, will be calculated by multiplying the Net Sales of
the Combination Product by the fraction A over A+B, in which A is the gross
selling price of the Product portion of the Combination Product when such
Product is sold separately during the applicable accounting period in which the
sales of the end-user product were made, and B is the gross selling price of the
other active ingredients, as the case may be, of the Combination Product sold
separately during the accounting period in question. All gross selling prices of
the elements of such Combination Product will be calculated as the average gross
selling price of the said elements during the applicable accounting period for
which the Net Sales are being calculated. In the event that, in any
country or countries, no separate sale of either such above-designated Product
or such above designated active ingredients of the Combination Product are made
during the accounting period in which the sale was made or if gross retail
selling price for the active ingredient cannot be determined for an accounting
period, Net Sales allocable to the Product in each such country will be
determined by mutual agreement reached in good faith by the Parties prior to the
end of the accounting period in question based on an equitable method of
determining same that takes into account, on a country-by-country basis,
variations in potency, the relative contribution of each active agent, component
or service, as the case may be, in the combination, and relative value to the
end user of each active ingredient. Notwithstanding the foregoing,
the Parties agree that, for purposes of this paragraph, [***] but
not [***] , and [***] will not be deemed to be
“active ingredients”.
***
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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
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Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.66 “Non-Breaching Party” has the meaning as
defined in Section 12.2.1.
1.67 “Out-of-Pocket Costs” means
costs and expenses paid to Third Parties (or payable to Third Parties and
accrued in accordance with IAS/IFRS (or GAAP for the US)) by Micromet and/or its
Affiliates, if applicable.
1.68 “Patent” means (a) any patent
and patent application in any country or supranational jurisdiction, and (b) any
provisional, substitution, division, continuation, continuation in part,
reissue, renewal, registration, confirmation, reexamination, extension,
supplementary protection certificate and the like, of any such patent or patent
application.
1.69 “Patent Challenge” has the meaning as
defined in Section 6.6.1.
1.70 “Percentage [***]
” has the
meaning as defined in Section 8.4.3.
1.71 “Phase 1 Trial” means a
clinical trial of a pharmaceutical product on healthy subjects or patients
designed with the primary purpose of determining safety, metabolism and
pharmacokinetic properties and clinical pharmacology of such product as and to
the extent defined for the United States in 21 C.F.R. § 312.21(a), or its
successor regulation, or the equivalent regulation in any
other country, including the Phase 1 part of any clinical trial that
is a combination Phase 1 Trial and Phase 2 Trial.
1.72 “Phase 2 Trial” means a
clinical trial of a pharmaceutical product on patients designed to
determine the safe and effective dose range in the proposed therapeutic
indication as and to the extent defined for the United States in 21 C.F.R. §
312.21(b), or its successor regulation, or the equivalent regulation in any
other country.
1.73 “Phase 3 Trial” means a
clinical trial of a pharmaceutical product on patients designed to (a) establish
that a drug is safe and efficacious for its intended use; (b) define warnings,
precautions and adverse reactions that are associated with the drug in the
dosage range to be prescribed; and (c) support a Marketing Approval of such
drug, as and to the extent defined for the United States in 21 C.F.R. §
312.21(c), or its successor regulation, or the equivalent
regulation in any other 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.
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Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
1.74 “Pivotal Trial” means (a) Phase
3 Trial, or (b) a Phase 2 Trial, or a combination Phase 2 Trial and Phase 3
Trial for which the relevant Regulatory Authority has determined that the data
generated in such trial could be sufficient, depending on its outcome, to
support a Marketing Approval for such pharmaceutical product.
1.75 “Proceeding Commencement
Date” has
the meaning as defined in Exhibit
I.
1.76 “Product” means any product
comprising a BiTE Antibody binding to the Collaboration Target.
1.77 “Program Transfer” has the meaning as
defined in Section 13.1.
1.78 “Receiving Party” has the meaning as
defined in Section 10.1.
1.79 “Recovery” has the meaning as
defined in Section 6.5.2(d).
1.80 “Regulatory Authority” means,
in a particular country or jurisdiction, any Governmental Authority involved in
granting approval to market or sell a Product, including any pricing and
reimbursement approvals, in such country or jurisdiction, including the FDA, the
EMEA, and any Governmental Authority equivalent to and performing some or all of
the functions the FDA or EMEA in the applicable jurisdiction.
1.81 “Regulatory Filing” means any
submission or application made or filed with a Regulatory Authority, including
any IND or BLA.
1.82 “ [***] ”
means [***] Percent ( [***] %),
unless [***] pursuant to the terms of Section 8.4.3 to
either [***] Percent ( [***] %)
or [***] Percent ( [***] %).
1.83 “ [***] Technology”
means any Patent or Know-How that is conceived or generated solely by
employees, agents or Service Providers of [***] or its Affiliates in the course
of [***] under this Agreement, but excluding in each case
any [***] Technology and
any [***] Technology. For
clarity, [***] Technology includes any Patent or Know-how
(a) developed in the conduct of performing [***] or
during [***] or [***] of the [***] , or (b)
Patent or Know-How that specifically relates to or arises out of
activities [***] by or on behalf of [***] or its
Affiliates other than those described in the preceding subsections in
preparation for [***] or [***] (but
not in preparation for [***] ) or [***] of
the [***] for [***] or [***] .
1.84 “ [***] Technology”
means any Collaboration Technology that is (i) conceived or generated solely by
employees, agents or Service Providers [***] or its Affiliates in
connection with the performance of this Agreement and (ii) developed or used in
the conduct of [***]
for [***] (including [***] Technology
conceived or generated in the conduct of (a) [***]
or [***] (including [***] for [***]
to [***] or (b) the [***] ), but excluding
any [***] Technology or any Patent or Know-How that
specifically relates to or arises out of activities conducted by or on behalf
of [***] or its Affiliates other than those described in the
preceding subsections in preparation for [***] or
later [***] or [***] of [***]
for [***] 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
1.85 “ [***] Technology”
means any Patent or Know-How that (a) claims or covers a [***] , and
(b) is Controlled by [***] or its Affiliates during the Term of this
Agreement.
1.86 “Sanofi Indemnitee” has the meaning as
defined in Section 14.2.
1.87 “ [***] Technology”
means any Patent or Know-How that (a) is Controlled
by [***] or its Affiliates and (b) in the case of any
Patent, would be [***] a [***] by the [***]
or [***] of a [***] or in the case of Know-How
is [***] for the [***] or would
be [***] for [***] or [***] of
a [***] , excluding in each
case [***] Technology, [***] Technology
and [***] Technology.
1.88 “
[***] Technology” means any Patent or
Know-How that (a) is Controlled by [***] or its Affiliates during the
Term of this Agreement, and (b) is [***] for the [***]
or [***] of a [***] in the [***] .
1.89 “Service Provider” has the meaning as
defined in Section 3.5.
1.90 “Support Memorandum” has the meaning as
defined in Exhibit
I.
1.91 “Term” has the meaning as
defined in Section 12.1.
1.92 “Territory” means all countries
of the world.
1.93 “Third Party” means any entity
other than Micromet, Sanofi or their respective Affiliates.
1.94 “Third Party Claim” has the meaning as
defined in Section 14.1.
1.95 “ [***] ” means any of the
agreements listed in Exhibit
D.
1.96 “Valid Claim” means
an [***] of an [***] that has not (i) expired
or been canceled, (ii) been declared invalid by a decision of a court or other
appropriate body of competent jurisdiction, from which no appeal is or can be
taken, (iii) been admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise, or (iv) been abandoned or disclaimed.
2.
|
Collaboration
Governance
|
2.1 Joint
Steering Committee.
2.1.1 Establishment of Joint Steering
Committee. The Parties will establish a joint steering
committee (the “JSC”)
within thirty (30) days of the Effective Date, to oversee the development of the
Products and the activities to be performed by the JPT under this
Agreement. Each Party will appoint three (3) employees with senior
level authority and expertise to serve as their representatives on the
JSC. From time to time, on written notice to the other Party,
Micromet and Sanofi each may substitute any of its representatives on the
JSC. Each Party will designate one of its members of the JSC as a
co-chairperson (each a “Co-Chair”). Subject
to the provisions of this Section 2, the JSC will establish its own procedural
rules for its operation.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
2.1.2 Tasks of the
JSC. The JSC will have the power only to: (a) establish the
overall development and regulatory strategy for the Products and the selection
of Indications, (b) nominate a BiTE Antibody for Sanofi’s approval as a Lead
Candidate; (c) oversee the conduct of the development of the Products under this
Agreement; (d) monitor the activities and performance of the JPT; (e) review and
approve in writing any updates or amendments to the Development Plan including
the Micromet Development Expenses; (f) monitor the progress of and coordinate
the activities undertaken pursuant to the Development Plan; (g) review new
dosage forms and new formulations or delivery systems; and (h) take such other
actions as are expressly delegated to the JSC in this Agreement. The
JSC will not have any power to amend this Agreement.
2.1.3 JSC Meetings. The
JSC will meet once every Calendar Quarter. Meetings may be held in
person or by means of telecommunication (telephone, video, or web conferences);
provided, however, that at least two
meetings per year will be held in person. The JSC may meet more
frequently by agreement of the Co-Chairs. The Co-Chair of a Party,
alternating with the Co-Chair of the other Party, will be responsible for
organizing the meetings of the JSC and for distributing the agenda of the
meetings. The organizing Co-Chair will include on the agenda any item
within the scope of the responsibility of the JSC that is requested to be
included by any member of the JSC, and will distribute the agenda to the JSC no
less than one (1) week before the meeting. Each Party may, in its
discretion, invite non-voting employees, consultants or advisors (which
consultants and advisors will be under an obligation of confidentiality no less
stringent than the terms set forth in Section 10) to attend any meeting of the
JSC.
2.1.4 Meeting
Minutes. The Co-Chair who organized the JSC meeting (or their
designee) will prepare the meeting minutes within seven (7) Business Days after
each meeting, and will send it to all members of the JSC for review and
approval. Minutes will be deemed approved unless any member of the
JSC objects to the accuracy of such minutes by providing written notice to the
other members of the JSC within fourteen (14) Business Days of receipt of the
minutes. In the event of any such objection that is not resolved by
mutual agreement of the Co-Chairs, such minutes will be amended to reflect such
unresolved objection.
2.1.5
Decision Making.
(a) The
JSC will take action on matters within its power by unanimous consent of the
members of the JSC, with each Party having a single vote, irrespective of the
number of JSC members in attendance at a meeting, or by a written resolution
signed by the Co-Chairs.
(b) If
the JSC is unable to reach unanimous consent on a particular matter, then either
Party may provide written notice of such unresolved matter to the Alliance
Managers who will try to facilitate the resolution of such issue. If
the JSC is unable to resolve such matter within thirty (30) days after a Party
provided written notice to the Alliance Managers, then the matter will be
escalated, by written notice, to the respective Executive Officers of each
Party. The Executive Officers (or his or her designee, who must be a
member of the Party’s senior management with appropriate decision-making
authority, but who is not a member of the JSC, JPT or the Alliance Manager) of
each Party will meet at least once in person to discuss such matter and use
their good faith efforts to resolve the unresolved matter within thirty (30)
days after the matter has been escalated by written notice to the Executive
Officers. If the Executive Officers (or their designees) cannot reach
agreement on how to resolve such matter within the thirty (30) day time period,
the Executive Officer of [***] will have the authority
to [***] a [***] on the matter in lieu of
the [***] of the [***] . Without limiting the
generality of the foregoing [***] will have
the [***] (a) to designate a [***] as a [***] ,
(b) to designate a [***] as a [***] for further
development as a [***] , and (c) to approve the filing
of [***] for a Product, in each case subject to [***]
obligations 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
(c) Notwithstanding
the terms of Section 2.1.5(b), the Executive Officer of [***] will
not have the authority to make a [***] that would
(i) [***] the [***] of [***]
of [***] , or [***] or [***] obligations under
the [***] ; or (ii) [***] any [***]
or [***] during the [***] ( [***] ) [***] following
the [***] that materially [***] the [***] of
the [***] from that described in the [***] attached as
[***]
.
(d) Notwithstanding
the terms of Sections 2.1.5(b) and (c) above, if the matter concerns a dispute
regarding the interpretation of this Agreement, the performance or alleged
nonperformance of a Party’s obligations under this Agreement, or any other
alleged breach of this Agreement, such matter will be resolved in accordance
with the terms of Section 17.4.
2.2 Joint
Project Team.
2.2.1 Establishment of Joint Project
Team. The Parties will establish a joint project team (the
“JPT”) to oversee the
research and development of Products under this Agreement and for the
performance of the [***] . The JPT will consist of
representatives of each Party designated by the JSC. Each Party will
designate one of its JPT members as the project team leader (each a “JPT Leader”) who will be the
primary contact person for the other Party for all operational matters relating
to the development of a Product by such Party. From time to time, on
written notice to the other Party, Micromet and Sanofi each may substitute any
of its representatives on the JPT. Upon completion of
the [***] or the withdrawal by either Party from the JSC,
the JPT will automatically be disbanded.
2.2.2 Tasks of the
JPT. The JPT will: (a) oversee the day-to-day activities of
the Parties in the performance of the Development Plan; (b) develop and propose
updates to the Development Plan for review and approval by the JSC in accordance
with Section 2.1.2, including
the [***] and [***]
for [***] and [***] approved by the
JSC; (c) provide a quarterly written report to the JSC summarizing the Parties’
progress with respect to the development of Products under this Agreement; and
(d) take such other actions as are expressly delegated to the JPT by the JSC or
by the terms of this Agreement. The JPT will not have any power to amend this
Agreement or to make decisions assigned to the JSC, and will have only such
powers as are specifically delegated to it by the JSC or 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
2.2.3 JPT Meetings. The
JPT will meet in plenum
or in subgroups as often as required for the expeditious performance of the
Development Plan, but not less than once every Calendar Quarter prior to the
next JSC meeting. Meetings may be held in person or by means of
telecommunication (telephone, video, or web conferences); provided, however, that at least two
meetings per year will be held in person. The JPT Leaders will be
responsible for establishing the meeting schedule, and will alternate in
organizing the meetings of the JPT. The JPT Leader organizing a JPT
meeting will be responsible for distributing the agenda of the
meeting. The organizing JPT Leader will include on the agenda any
item within the scope of the responsibility of the JPT that is requested to be
included by any member of the JPT, and will distribute the agenda to the JPT no
less than one (1) week before the meeting. Each Party may, in its
discretion, invite non-voting employees, consultants or advisors (which
consultants and advisors will be under an obligation of confidentiality no less
stringent than the terms set forth in Section 10) to attend any meeting of the
JPT.
2.2.4 Meeting
Minutes. The JPT Leader who organized the JPT meeting (or
their designee) will prepare the meeting minutes within seven (7) Business Days
after each meeting, and will send it to all members of the JPT for review and
approval. Minutes will be deemed approved unless any member of the
JPT objects to the accuracy of such minutes by providing written notice to the
other members of the JPT within fourteen (14) Business Days of receipt of the
minutes. In the event of any such objection that is not resolved by
mutual agreement of the JPT Leaders, such minutes will be amended to reflect
such unresolved objection.
2.2.5 Decision
Making. The JPT will agree on proposals and recommendations to
the JSC on all matters within the responsibility of the JPT by unanimous
consent, with each Party having a single vote, irrespective of the number of JPT
members in attendance at a meeting, or by a written resolution signed by the JPT
Leaders. All proposals and recommendations of the JPT will be
submitted for approval by the JSC at the subsequent JSC meeting. If
the JPT is unable to reach unanimous consent on a particular matter, such matter
will be submitted to the JSC for resolution in accordance with Section
2.1.5.
2.3 Alliance
Managers.
2.3.1 Appointment. Each
of the Parties will appoint a single individual (who may be such Party’s JPT
Leader) to act as a single point of contact between the Parties to facilitate
the effective exchange of information between the Parties and discuss the
performance of this Agreement (each an “Alliance
Manager”). Each Party may change its designated Alliance
Manager from time to time upon written notice to the other Party. Any
Alliance Manager may designate a substitute to temporarily perform the functions
of that Alliance Manager by written notice to the other Party.
2.3.2 Responsibilities. The
Alliance Managers will use good faith efforts to attend all JSC and JPT meetings
and support the Co-Chairs in the discharge of their
responsibilities. Alliance Managers will be nonvoting participants in
the JSC and JPT meetings, unless they are also appointed members of the
JSC. An Alliance Manager may bring any matter to the attention of any
committee if such Alliance Manager believes that such matter warrants such
attention. Each Alliance Manager will be charged with creating and
maintaining a collaborative work environment within and among the
committees. In addition, each Alliance Manager: (a) will coordinate
the interactions between the relevant functional representatives of the Parties;
(b) will identify and bring disputes to the attention of the JSC in a timely
manner; (c) will assist with governance activities, such as the conduct of
required committee meetings and drafting of meeting minutes; (d) will ensure
that relevant action items resulting from such meetings are appropriately
carried out or otherwise addressed; and (e) will serve as the initial point of
contact to resolve any disputes between the Parties. From time to
time, each Party may reasonably request that the Alliance Managers facilitate a
meeting between appropriate senior level executives of the Parties to discuss
any issues relevant to the relationship of the Parties under this Agreement and
the current status of the Product.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
2.4
[***] Committees. At any time during the Term after
completion of the [***] and for any reason, each Party
will have the right to [***] from [***] in
the [***] upon written notice to the other
Party. Upon any such [***] , the JSC will
be [***] and the [***] will remain
the [***] for the exchange of information under this
Agreement.
3.
|
Product
Development
|
3.1 Development
Plan.
3.1.1 The
Development Plan will be designed to accomplish the filing of the first IND for
a Product [***] ( [***] ) [***] after
the [***] and the filing of BLAs and the receipt of
Marketing Approval for a Product in the [***] . The
Development Plan will include a budget of Micromet Development Expenses to be
incurred pursuant to the Development Plan. The Development Plan will set
specific objectives and timelines for carrying out development activities
sufficient in scope and quality to progress the development of a Product towards
Marketing Approval within timelines and using standards customary in the
biopharmaceutical industry for Products at a similar stage of development and
with similar market potential. The Parties agree that the initial
Product as described in the Development Plan to be developed under this
Agreement will be based on Micromet’s new [***] and [***]
Version [***] .
3.1.2 The
initial Development Plan for the initial Product covering the period from the
Effective Date through the first IND filing is attached as Exhibit B (the “Initial Development
Plan”). During the [***] , the JPT will
periodically review and propose amendments to the Development Plan within the
parameters established in Section 3.1.1 and 3.2 for approval by the JSC, to
reflect the progress achieved and the further development activities to be
undertaken by the Parties in the development of a Product under this Agreement,
but not less than once every year in conjunction with the Parties’ budget and
program review cycle. After completion of the [***] , the
Development Plan will be updated by Sanofi consistent with the terms of this
Agreement, and any such updates will be provided to Micromet together with the
quarterly progress reports delivered pursuant to Section 3.4.
3.2 Allocation of
Responsibilities. Each Development Plan will reflect the
following allocation of responsibilities:
***
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
3.2.1 BiTE Antibody Generation and
Research. Micromet will be responsible for conducting the
generation and optimization of BiTE Antibodies binding to the Collaboration
Target, and for conducting any further research activities. Micromet
will provide to the JSC BiTE Antibodies as proposed Lead Candidates generated
within the scope of the Development Plan for the JSC’s review and
selection. Within thirty (30) days after submission by Micromet of
the proposed Lead Candidates, the JSC (subject to [***] in
Section [***] ) will select the Lead Candidate binding to the
Collaboration Target for further development as a Product. If the JSC
does not nominate the proposed BiTE Antibody as a Lead Candidate and the JSC
recommends that such BiTE Antibody should be subject to additional
work, then the Parties will amend the Development Plan to reflect any
desired additional activities and Micromet will use Commercially Reasonable
Efforts to conduct such activities. Following completion of such
activities, Micromet will re-submit such BiTE Antibody to the JSC for Lead
Candidate nomination in accordance with the terms of this Section
3.2.1.
3.2.2 [***] . Micromet
will be responsible for the development of [***] and for
conducting of [***]
during [***] in [***] and [***]
..
3.2.3 [***] . Micromet
will be primarily responsible for conducting [***] testing
in [***] for BiTE Antibodies binding to the Collaboration
Target.
3.2.4 [***] . Sanofi may
conduct certain [***] (e.g. [***] ) and will be
primarily responsible for performing [***] testing of the Products
(other than any studies requiring [***] or [***] ),
provided that Micromet will participate in the design and monitoring of such
studies and conduct [***] testing.
3.2.5 [***] and [***]
..
(a) Micromet
will be responsible for the development of
a [***] activities, the development and performance
of [***] assays, the development of an [***] ,
and the [***] of BiTE Antibodies binding to the Collaboration Target
and of any Product for [***] and [***] up to and
including [***] . The foregoing activities will be part of
the [***] agreed upon in the [***]
.. Unless the Parties determine otherwise (which determination will be
made not less than [***] ( [***] ) [***] prior
to the planned start of the first [***] ), Sanofi or its designee
will be responsible for the manufacture of the Product for [***]
..
(b) Upon
completion of the development of the [***] and with
appropriate lead time prior to the initiation of the [***] of
the [***] by [***] for [***]
or [***] , as the case may be, Micromet will transfer to Sanofi
Micromet’s [***] , [***] assays, [***] , and
any other information, documentation and materials as is reasonably required by
Sanofi to [***] the [***] in its [***] , or
its [***] . Sanofi will reimburse Micromet at the [***]
and for [***] for such activities performed by
Micromet.
(c) Sanofi
or its designee will be responsible for further [***]
to [***] , further [***] and
the [***] of any BiTE Antibody used in the Product and
the [***] and [***] of the [***]
for [***] and for [***] . In
addition, Sanofi may conduct certain [***] as further
detailed in the [***] .
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
(d) If
a Party will manufacture and supply Product to the other Party for the
performance of clinical trials, the Parties will enter into a “Quality
Agreement” describing the responsibilities of each Party relating to quality
control and release of the Product, which agreement hereby is incorporated in
and made part of this Agreement by reference.
3.2.6
Clinical Development.
(a) Phase 1 Clinical Trials.
Micromet will take the lead in the [***] of the [***] for
the Phase 1 Trials for review and approval by the JPT and the
JSC. Micromet will be responsible for the performance of Phase 1
Trials of a Product, [***] and associated regulatory
activities. Sanofi will participate in the [***] of
the [***] including [***] , the review and assessment of
safety and efficacy data, and attend the meetings with the data review committee
and the drug safety monitoring board for the various clinical
trials.
(b) Phase 2 Clinical
Trials. Sanofi will take the lead in the [***] of
the [***] for the [***] for review and approval
by the JPT and the JSC. Sanofi will be responsible for the
performance of Phase 2 Trials of a Product and associated regulatory
activities. Micromet, at its own cost and expense, may participate in
the [***] of the [***] including [***] , and
the review and assessment of safety and efficacy data, and attend the meetings
with the data review committee and the drug safety monitoring board for the
various clinical trials; provided, however, Sanofi will reimburse Micromet at
the FTE Rate and for all Out-of-Pocket Costs for such activities performed by
Micromet at the request of Sanofi or pursuant to the Development
Plan.
(c) Phase 3 and Pivotal
Trials. Sanofi will draft the [***] for
the [***] for review by the JSC, and will be fully
responsible for the performance of Pivotal Trials of a Product in accordance
with the Development Plan.
3.3
Diligence in Development.
3.3.1 Micromet will use
Commercially Reasonable Efforts to generate BiTE Antibodies binding to the
Collaboration Target, and to perform the activities assigned to it in the
Development Plan. All efforts of Micromet’s Affiliates and Micromet’s
Service Providers will be considered efforts of Micromet for the purpose of
determining Micromet’s compliance with its obligations under this Section
3.3.1.
3.3.2 Sanofi will use
Commercially Reasonable Efforts to develop a Product and obtain Marketing
Approval for such Product in the Major Markets, and to perform the activities
assigned to it in the Development Plan. All efforts of Sanofi’s
Affiliates and Sanofi’s Service Providers will be considered efforts of Sanofi
for the purpose of determining Sanofi’s compliance with its obligations under
this Section 3.3.2.
3.4 Reports. During
the [***] , each Party will provide through the JPT regular reports
to the JSC detailing its development activities under the Development Plan and
the results of such activities. After completion of
the [***] or the termination of the JSC by either Party,
Sanofi will provide to Micromet [***] written progress reports during
each [***] with a summary of [***] in
the [***] of the [***] of
the [***] and a summary of Sanofi’s [***] for the
Product.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
3.5 Use of Service
Providers. Each Party may perform any of its obligations under
the Development Plan through Third Party service providers such as contract
research organizations, contract manufacturing organizations, consultants or
other independent contractors (each a “Service
Provider”). The Party engaging a Service Provider will be
responsible for conducting such qualification audits as may be required under
GxP regulations prior to the engagement of such Service
Provider. Each Party will inform the other Party of the identity of,
and the nature of services provided by the Service Providers used by such
Party. The Party using a Service Provider will remain responsible to
the other Party for the work performed by the Service Provider. Each
Party will ensure that such Service Providers are bound in writing by
obligations of confidentiality and non-use regarding Confidential Information
that are substantially the same as or more stringent than those undertaken by
the Parties pursuant to Section 10 hereof and, the provisions on intellectual
property ownership hereunder and that the agreement with such Service Providers
contains customary terms providing for the assignment to such Party of all
intellectual property developed in the course of performing the services for
such Party.
4.
|
Commercialization
|
4.1 Commercialization. Sanofi
will be solely responsible for and bear all costs and expenses associated with
the Commercialization of a Product in the Territory during the
Term. Sanofi will be responsible for all aspects of the
Commercialization of the Product in the Territory, including, booking sales and
distribution and performance of related services, handling all aspects of order
processing, invoicing and collection, inventory and receivables, and providing
customer support, including handling medical queries. Sanofi will
develop an annual commercialization plan for a Product that complies and is in
accordance with Sanofi’s [***]
for [***] products.
4.2 Diligence in
Commercialization. Sanofi will use Commercially Reasonable
Efforts to Commercialize a Product in the Territory.
4.3 Branding, Trademarks, Trade Dress,
and Logos. Sanofi will solely own, and will be solely
responsible for selecting, the trademark used to identify any Product that will
be Commercialized in the Territory pursuant to this Agreement. Sanofi
will oversee the filing, prosecution and maintenance of all trademark
registrations for a Product in the Territory, and Sanofi will be responsible for
the payment of any and all costs relating to such filing, prosecution, and
maintenance. Sanofi will have sole responsibility for, and will be
the sole owner of, all trade dress, logos, slogans, and designs used on and in
connection with any Product that will be Commercialized in the Territory
pursuant to this Agreement.
***
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.
|
Regulatory
Matters
|
5.1 Regulatory
Filings.
5.1.1 Unless
the JSC determines otherwise (with the consent of the Micromet representative),
Micromet will be responsible for the preparation, filing, prosecution and
maintenance of any Regulatory Filings for a Product up to and including the
completion of the first [***] and will be the sponsor of
such trial. Sanofi will assist Micromet, as may be reasonably
necessary, in the preparation of Regulatory Filings, including providing
necessary documents or other materials required by Applicable Law, all as
provided for in the Development Plan. The sponsor of a clinical trial
of the Product performed pursuant to this Agreement will be responsible for and
control, as required by Applicable Law, the performance of such clinical trial,
including but not limited to any decisions relating to the safety of any
subjects participating in such clinical trial.
5.1.2 As
soon as practicable after the completion of the first [***] ,
Micromet will transfer to Sanofi all Regulatory Filings for such Product in the
Territory to the extent necessary or useful for Sanofi to conduct the continued
development and Commercialization of the Product. Micromet and Sanofi
will execute such documents and take such actions as are reasonably necessary to
effectuate the foregoing transfers. After the transfer of such
Regulatory Filings for a Product, Sanofi will be responsible for performing all
regulatory activities including those necessary for filing BLAs and obtaining
and maintaining any Marketing Approvals and other regulatory approvals required
for the Commercialization of a Product in the Territory.
5.2 Communications and Meetings with
Regulatory Authorities. The Party that is the sponsor of an
IND of a Product will be responsible for any communications with the Regulatory
Authorities occurring or required in connection with obtaining or maintaining
any Regulatory Filings or Marketing Approvals for a Product; provided, however,
that during the time that Micromet is the sponsor of an IND of a Product,
Micromet will coordinate with Sanofi regarding its interactions with Regulatory
Authorities. The responsible Party will promptly provide the other
Party with copies of all written or electronic correspondence received from
Regulatory Authorities relating to a Product, and will provide such other Party
with a reasonable opportunity to provide comments on any responses to such
Regulatory Authorities. In addition, the responsible Party will
promptly notify the other Party in writing and in advance of any meeting with
any Regulatory Authority in the U.S. or the EU relating to a Product, and such
other Party may, at their own expense, have an employee or consultant
participate in such meeting as an observer. In addition to the
foregoing, Sanofi must approve the filing of all INDs for any Product under this
Agreement.
5.3 Clinical Safety and Pharmacovigilance
Matters. The Party that is the sponsor of an IND will be
responsible for handling, recording and reporting of adverse events arising in
the development of the Product, and will establish the standard operating
procedures implementing the requirements under Applicable
Law. Micromet will establish and maintain the global safety database,
and will transfer such database to Sanofi together with the transfer of the IND
of a Product to Sanofi as provided in Section 5.1.2. Prior to the
initiation of the first Phase 1 Trial, the Parties will enter into
“Pharmacovigilance Agreement” describing the responsibilities of each Party
relating to clinical safety and pharmacovigilance.
***
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
Audits and Inspections.
5.4.1 Each
Party will perform such internal audits and external audits of its Service
Providers, and will have the right, at its own cost, to conduct such audits of
the other Party’s facilities, records, and Service Providers as is reasonably
requested by a Party or required under Applicable Laws to assure itself of the
compliance with GxP regulations in the development of a Product; provided, however, that such
audits of the other Party or its Service Providers will be conducted not less
than [***] ( [***] ) Business Days advance notice during regular
business hours, and may not be conducted more than once in
any [***] period. The audited Party will
correct the findings of any such audit in accordance with standard industry
practice. In the event of recalls, voluntary withdrawals,
manufacturing process changes, deviations, out-of-specification results or
protocol violations, the other Party may conduct additional audits as such Party
may deem appropriate and necessary to determine the cause of, and to follow up
on such events.
5.4.2 Each
Party will inform the other Party without delay of any inspections its
facilities or records relating to the development or manufacture of a Product
that are planned to be performed by any Regulatory Authorities. The
Party to be inspected will take all reasonable measures in accordance with
standard industry practice to prepare for such inspections. The other
Party will have the right to have an employee or consultant attend such
inspections as an observer.
5.5
Recalls and Voluntary
Withdrawals. If either Party becomes aware of information
relating to any Product that indicates that a unit or batch of Product may not
conform to the specifications thereof, or that potential adulteration,
misbranding, and/or other issues have arisen that relate to the safety or
efficacy of such released Products, it will promptly notify the other Party
thereof in writing. The holder of the IND for the applicable clinical
trial, or, Sanofi after Marketing Approval of a Product, will have the
right, [***] to control any Product recall, field
correction, or withdrawal of any Product in the Territory; provided, however, that such
Party will promptly notify the other Party of any recall action being
considered, and where practicable, consider the views of the other Party prior
to taking any recall action.
5.6
Regulatory
Records. All activities performed by or on behalf of a Party
under the Development Plan will be completely and accurately recorded, in
sufficient detail and in good scientific manner. Each Party will
maintain, or cause to be maintained, for at least [***] ( [***] )
years after the termination of this Agreement, or for such longer period as may
be required by Applicable Law, complete and accurate records of its respective
development activities with respect to a Product, including the drug master
file, Product recalls, and other records made in connection with or filed with
any Regulatory Authority. Each Party will have the right, during
normal business hours and upon reasonable notice, to inspect and copy any such
records, except to the extent that a Party reasonably determines that such
records contain Confidential Information that is not licensed to the other
Party, or to which the other Party does not otherwise have a right
hereunder.
6.
|
Intellectual
Property Matters
|
6.1 Inventorship. Inventorship
with respect to any invention or discovery that is or may be patentable made
pursuant to activities conducted pursuant to this Agreement will be determined
in accordance with United States rules of inventorship.
***
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
6.2 Ownership. Micromet
will own all right, title and interest in and to
any [***] Technology, [***] Technology, [***] Technology,
and Micromet’s rights and interest in [***] Technology,
provided that Micromet will [***] Micromet’s right, title
and interest in and to any [***] Patent, whereupon
such [***] Patent will cease to be part of
the [***] . Sanofi will own all right, title and interest
in and to any [***] Patent assigned to Sanofi pursuant to
this Section 6.2 and
any [***] Technology, [***] Technology, [***] Technology
and Sanofi’s rights and interest
in [***] Technology. Micromet and Sanofi will
each [***] an [***] in
any [***] Technology, without obligation to account to the
other for the exploitation thereof or to seek consent of the other for the grant
of any licenses under or the enforcement
of [***] Technology, except as expressly limited by the
terms of this Agreement.
6.3 Disclosure of
Know-How. The Parties will disclose Know-How licensed to the
other Party under this Agreement and required by such Party to perform
activities assigned to it under this Agreement through a process reasonably
acceptable to both Parties. If such Know-How is a patentable
invention, the owner thereof pursuant to Section 6.2 above may withhold the
disclosure to the other Party until after the filing of a patent application
claiming such invention.
6.4 Filing,
Prosecution and Maintenance of Patents.
6.4.1 [***] Technology; [***] Technology. Subject
to the terms of this Section 6, Micromet will use Commercially Reasonable
Efforts to file, prosecute, defend and maintain (including the filing of any
extension or supplementary protection certificate) at its cost any Patents
claiming inventions or discoveries that are part of the [***]
Technology and [***] Technology. Micromet will provide
Sanofi with an update of the filing, prosecution and maintenance status for each
of the Patents within the [***] Technology (to the extent of any
claims that cover the composition or use of the Product) and within
the [***] Technology on a periodic basis, and will use Commercially
Reasonable Efforts to consult with and cooperate with Sanofi with respect to the
filing, prosecution and maintenance of the [***] Technology (to the
extent of any claims that cover the composition or use of the Product)
and [***] Technology, including providing Sanofi with drafts of
proposed material filings to the extent of any claims that cover the composition
or use of the Product to allow Sanofi a reasonable opportunity for review and
comment before such filings are due. Micromet will give reasonable
consideration to any suggestions or recommendations of Sanofi concerning the
preparation, filing, prosecution, defense and maintenance of such Patents to the
extent of any claims that cover the composition or use of the
Product. Micromet will file and maintain such Patents,
at [***] and [***] in the [***] specified in
[***] and in
any other country requested by Sanofi. Sanofi will reimburse Micromet
for costs and expenses incurred for filing and maintenance of such Patents in
those [***] by [***] ; provided that if
Micromet [***] to [***] in such [***]
for [***] , then [***] will [***] on
a [***] (based solely on the total number
of [***] including [***] ).
6.4.2 [***] Technology; [***]
Technology. Sanofi will have the right to file, prosecute,
defend and maintain at its costs any Patents claiming inventions or discoveries
that are part of the [***] Technology or [***]
Technology. Sanofi will reasonably inform Micromet and consult with
Micromet regarding the filing, prosecution, defense and maintenance of Patents
within the [***] Technology and any Patents within
the [***] Technology under which Micromet has taken a license under
Section 7.6.3 and will give reasonable consideration to any suggestions or
recommendations of Micromet concerning the preparation, filing, prosecution,
defense and maintenance of such Patents to the extent specifically applicable to
BiTE Antibodies.
***
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
6.4.3 [***] Technology. With
respect to inventions or discoveries within the Joint Collaboration Technology,
the JSC will decide on a case-by-case basis which [***]
will [***] and [***] Patents claiming such
inventions or discoveries giving good faith and due consideration to the
following: Micromet is anticipated to bear such responsibility with
respect to Patents within [***] Technology primarily related to
the [***] , and Sanofi is anticipated to bear such responsibility
with respect to Patents within [***] Technology primarily related to
a [***] . Any such filing, prosecution and maintenance
(including the filing of any extension or supplementary protection certificate),
will be made in both Parties’ name. The Parties will [***]
the [***] for the foregoing activities in
the [***] specified in [***] and Sanofi
will [***] the [***] for the foregoing
activities in any [***] not [***] . The filing
Party will reasonably inform the other Party and consult with the other Party
and, to the extent possible, will undertake the filing, prosecution and defense
of any Patents within [***] Technology in a way that will not be
detrimental to the prosecution, issuance and validity of Patents that are part
of [***] Technology or [***] Technology, or the
development or Commercialization of a Product.
6.4.4 Cooperation. Each
Party will provide the other Party with summaries (or copies as reasonably
requested) of patent applications, office actions (including restriction
requirements) and substantive correspondence with the applicable patent office
for Patents licensed to the other Party under this Agreement during such
preceding Calendar Quarter. Each Party will cooperate with the other
Party, execute all lawful papers and instruments and make all rightful oaths and
declarations as may be necessary in the preparation, prosecution and maintenance
of all patents and other filings referred to in this Section 6.4. If
Micromet does not wish to continue the prosecution of any claim in a Patent
comprising the [***] Technology, or [***] Technology that
covers the composition or use of the Product, then it will inform Sanofi thereof
in writing with sufficient advance notice to reasonably enable Sanofi to assume
the filing or prosecution of such claim(s), at Sanofi’s cost. If
Sanofi decides to assume the filing or prosecution of such claim(s), Micromet
will assign such claim(s) to Sanofi whereupon such Patents will cease to be part
of the [***] Technology and Sanofi will agree to assume all of
Micromet’s obligations under such Patents under applicable Law. In
addition, Micromet will not finally discontinue the prosecution of any claim in
a Patent comprising the [***] Technology that covers the composition
or use of the Product without having used good faith and reasonable efforts in
its discretion to prosecute such claim. Micromet will inform and
discuss any such discontinuance with respect to the [***] Technology
pursuant to the terms of Section 6.4.1 above. In
addition, Sanofi will not finally discontinue the prosecution of any claim in a
Patent comprising the [***] Technology or [***] Technology
that relates to BiTE Antibodies without having used good faith and reasonable
efforts in its discretion to prosecute such claim. Sanofi will inform
and discuss any such discontinuance with respect to the [***]
Technology or [***] Technology pursuant to the terms of Sections
6.4.2 and 6.4.3 above. A Party will promptly notify the other Party
in the event that it becomes aware of any Third Party Patent or Know-How that
may constitute [***] .
***
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
6.5
Enforcement of
Patents.
6.5.1 Notice. If either
Party learns that a Third Party is infringing or allegedly infringing any Patent
within the Licensed Technology it will promptly notify the other Party thereof
including available evidence of infringement. The Parties will
cooperate and use reasonable efforts to stop such alleged infringement without
litigation.
6.5.2 Enforcement
Actions.
(a) The
Party owning the infringed or allegedly infringed Patent within the Licensed
Technology (or Micromet with respect to
any [***] Technology) will have the first right (but not
the obligation) to take the appropriate steps to remove the infringement or
alleged infringement thereof by a Third Party, including, by initiation,
prosecution and control at its own expense of any suit, proceeding or other
legal action by counsel of its own choice.
(b) The
Party that is not the plaintiff in an action brought by the other Party pursuant
to this Section 6.5.2 will have the right, at its own expense, to be represented
in any such action by counsel of its own choice. In addition, such
Party agrees to be joined as party plaintiff if necessary to prosecute the
action or proceeding and to give the other 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.
(c) If
the alleged infringement of a Patent is based on the fact that a Third Party is
selling a product that is competing with a Product, and if a Party fails to
bring an action or proceeding to remove the infringement pursuant to subsections
(a) and (b) above within [***] ( [***] )
days of a written request for such action by the other Party, then
such other Party will have the right (but not the obligation) to bring any such
action or proceeding by counsel of its own choice; provided, however, that the
Party with the initial right to bring such action will have the right to approve
in writing any settlement of any claim, suit or action involving its Patents
such approval not to be unreasonably withheld. The [***] (
[***] ) day period in the immediately preceding sentence will be shortened as
reasonably necessary to enable a Party to initiate a suit or take other
appropriate action if, in the absence of such shortening, a loss of rights with
respect to such suit or other action would occur (e.g., if a generic
pharmaceutical maker files an abbreviated new drug application or analogous
application for which the reference listed drug is a Product and, in order to
obtain an automatic stay from the FDA with respect to the approval of such
application, a patent infringement suit must be brought within a shorter period
of time).
(d) If
the alleged infringement of a Patent within the Licensed Technology
is based on the fact that a Third Party is selling a product that is competing
with a Product, any settlements, damages or other monetary awards (the “Recovery”) recovered by a
Party in an action pursuant to this Section 6.5.2 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, with any remaining amounts (if any) to be
allocated 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
(i) If
Sanofi pursued such action, the Recovery will be deemed to be Net Sales and
Sanofi will pay a royalty to Micromet as provided in Section 8.4 (without taking
into account any reduction under Section 8.4.3).
(ii) If
Micromet pursued such action, the Recovery will be retained by Micromet to the
extent that the Recovery is based on the damages incurred by Micromet, and
deemed Net Sales to the extent based on the damages incurred by Sanofi (without
taking into account any reduction under Section 8.4.3), and Micromet will pay
the portion of such Recovery based on the damages incurred by Sanofi to Sanofi
after deducting the royalty due to Micromet thereon pursuant to Section 8.4
(without taking into account any reduction under Section 8.4.3).
In all
other cases regarding the enforcement of any Patent under this Section 6.5, any
Recovery will be retained by the Party maintaining the action and if maintained
jointly, in proportion to the costs and expenses incurred by the Parties in
maintaining such action, in each case after deducting each Party’s legal
expenses and costs incurred in such action.
6.6
Consequences of
Patent Challenge.
6.6.1 Micromet will have
the right to terminate this Agreement by written notice effective upon receipt
if Sanofi or any of its Affiliates directly, or indirectly through assistance
granted to a Third Party, commence any interference or opposition proceeding,
challenge the validity or enforceability of, or oppose any extension of or the
grant of a supplementary protection certificate with respect to, any Patent
within the Licensed Technology (each such action a “Patent
Challenge”).
6.6.2 Sanofi will
include provisions in all agreements granting sublicenses of Sanofi’s rights
hereunder providing that if the sublicensee or any of its affiliates undertake a
Patent Challenge with respect to any Patent within the Licensed Technology under
which the sublicensee is sublicensed, then such sublicense will automatically
terminate.
7.
|
License
Grants
|
7.1 License Grants by
Micromet. Subject to the terms and conditions set forth in
this Agreement, Micromet grants to Sanofi an exclusive, royalty-bearing license
or sublicense, under the Licensed Technology, to research, develop, make, have
made, use, offer for sale, sell, import, export and otherwise Commercialize
Products in the Field in the Territory.
7.2 [***] . Sanofi
acknowledges and agrees that it has received a copy of each [***] ,
and that the sublicense granted in Section 7.1 under
any [***] Technology is subject to the terms of the
applicable [***] . Sanofi covenants not to take or fail to
take any action that violates the terms of
such [***] applicable to sublicensees, or that would cause
Micromet to be in breach of any of the terms of the [***] , other
than the payments due pursuant to such [***] which all
remain an express obligation of Micromet except as otherwise provided in Section
8.5.1. Notwithstanding the foregoing, Micromet will immediately
notify Sanofi if Micromet fails to meet any of its obligations, including any
payment obligations, under any of the [***] . If such a
failure will occur, Sanofi will have the right to step-in and meet such
obligations, including the right to make payment on behalf of Micromet, and
Micromet will take all necessary steps such that the other party to
such [***] accepts performance by Sanofi on behalf of
Micromet for such obligations. Any amounts paid by Sanofi pursuant to
the immediately preceding sentence will be credited towards any amount due to
Micromet from Sanofi under this Agreement except in the event and to the extent
of any amount that Micromet disputed in good faith as payable under the
applicable [***] .
***
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
7.3 Access
to [***] Technology.
7.3.1 Sanofi
will have the right to request from time to time the disclosure
of [***] Technology. Upon receipt of such request,
Micromet undertakes to use reasonable efforts to provide Sanofi a summary of
such [***] Technology in such detail as reasonably required for
Sanofi to determine its interest in seeking a license thereunder pursuant to
this Section 7.3.1. If Sanofi determines that any [***]
Technology would be [***] or [***] for
the [***] or [***] of a [***] , and that Sanofi desires to
obtain a license under such Patents or Know-How, then Sanofi will provide
Micromet with written notice of such determination.
7.3.2 If
such [***] Technology was generated by employees, agents
or Service Providers of [***] , the Parties will negotiate in good
faith the [***] for including such [***]
Technology in the [***] Technology, taking into
consideration [***] for [***] in the generation of
such [***] Technology and Sanofi will have the
rights granted in Sections 6.4 and 6.5 with respect to
such [***] Technology except as the Parties may otherwise
agree.
7.3.3 If
such [***] Technology was [***]
or [***] to [***] by a [***] , the Parties will
negotiate in good faith the [***] for including
such [***] Technology in
the [***] Technology, taking into
consideration [***] for [***] or [***] for
such [***] Technology; provided, however, (a) Sanofi
will be responsible for all [***] to
a [***] to the extent arising from the [***]
to [***] or Sanofi’s practice of the [***]
to [***] to such [***] Technology;
and (b) any license granted to Sanofi will be subject to the terms and
conditions of any Third Party license agreement under which
such [***] Technology is [***]
to [***] .
7.3.4 If the
Parties fail to reach an agreement on the [***] for
including [***] Technology in the [***] Technology
within [***] of Sanofi’s notice, the procedure described
in Section 17.4 will apply.
7.4 Access
to [***] Technology.
7.4.1 Sanofi
will have the right to request from time to time the disclosure
of [***] Technology that is available for a license by
Sanofi. Sanofi acknowledges that it only may receive a right to
license Patents and Know-How of a [***] that, if evaluated
under this Agreement (treating such Patent or Know-How as [***]
Technology or [***] Technology) would be eligible for license by the
particular [***] under substantially similar terms and
conditions (including financial terms) in all material respects. Upon
receipt of such request, Micromet undertakes to use reasonable efforts to
provide Sanofi a summary of such [***] Technology in such
detail as reasonably required for Sanofi to determine its interest in seeking a
license thereunder pursuant to this Section 7.4.1. If Sanofi
determines that [***] Technology would be [***]
or [***] for the [***] or [***] of
a [***] , and that Sanofi desires to obtain a license under such
Patents or Know-How, then Sanofi will provide Micromet with written notice of
such determination, and the Parties (and the
applicable [***] to the extent required) will negotiate in
good faith an amendment to this Agreement pursuant to which
such [***] Technology will be included in
the [***] Technology and licensed to Sanofi under the
terms of this Agreement and the terms of Micromet’s agreement with the
applicable [***] .
***
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
7.4.2
Subject to Section 7.4.1, (a) Sanofi will be responsible for all payments, if
any, due to a Third Party on account of any sublicense to any [***]
Technology to the extent arising from Sanofi’s practice of the license granted
to Sanofi, and (b) such license only will be granted to the extent that Sanofi
does not restrict the license of corresponding [***] Technology to
such [***] .
7.5 Sublicensing by
Sanofi. Subject to the terms and conditions of this Agreement,
Sanofi will have the right to sublicense all or part of the rights granted under
Section 7.1: (a) at any time, to an Affiliate but only for such
period of time as such entity remains an Affiliate of Sanofi, or to a Service
Provider solely to the extent necessary for the performance of any contract
research, contract manufacturing or other similar service; or (b) following
completion of the [***] for a Product, to
a [***] Company without the prior consent of Micromet or
to any other entity with the prior consent of Micromet, not to be unreasonably
withheld. In each case and as a condition of such sublicense, Sanofi
will remain responsible to Micromet for the performance of Sanofi’s obligations
under this Agreement (either directly by Sanofi or by Sanofi’s sublicensee),
provide to Micromet a copy of such sublicense together with a written
confirmation by the sublicensee that it agrees to be bound by the applicable
terms and conditions contained in this Agreement, and make Micromet a third
party beneficiary with respect to the enforcement of the applicable terms and
conditions against the sublicensee. For purpose of this Section 7.5,
a “
[***] Company” means a company that (i) is among
the [***] companies as ranked
by [***] from the [***] of [***] ,
(ii) has a [***] in all [***] , and (iii) has experience
and capabilities to conduct the [***] and [***] of
products for the [***] of [***] .
7.6 License
Grants by Sanofi.
7.6.1 Sanofi
Technology. Subject to the terms and conditions set forth in
this Agreement, Sanofi grants to Micromet a co-exclusive (together with Sanofi,
its Affiliates and permitted sublicensees), worldwide, fully-paid, royalty-free
license, under the Sanofi Technology, solely to conduct its obligations under
the Development Plan. Such license will be sublicensable
solely to Affiliates of Micromet and Service Providers for the provision of
services to Micromet, other than contract sales or Product detailing
activities.
7.6.2 [***]
Technology. Subject to the terms and conditions set forth in
this Agreement, Sanofi grants to Micromet a worldwide, non-exclusive,
fully-paid, royalty-free license (with the right to sublicense
to [***] as described in Section 7.6.4) under
the [***] Technology to research, develop, make, use, offer for sale,
sell, import, export and otherwise commercialize Micromet
Products. If Micromet desires to receive an exclusive version of the
foregoing license (which would be royalty-bearing and not fully-paid), the
Parties will negotiate in good faith the terms for such exclusive license
grant.
***
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
7.6.3 Access
to [***] Technology.
(a) Micromet
will have the right to request from time to time the disclosure
of [***] Technology. Upon receipt of such request, Sanofi
undertakes to use reasonable efforts to provide Micromet a summary of only such
Sanofi [***] Technology that Sanofi would consider granting a license
to, in such detail as is reasonably required for Micromet to determine its
interest in seeking a license thereunder pursuant to this Section
7.6.3.
(b) If
Micromet desires to obtain a license under such [***] Technology
described in Section 7.6.3(a), then Micromet will provide Sanofi with written
notice, and subject to [***] , the Parties will [***]
in [***] the [***] of a
[***] license under such [***] Technology, if
any. For purposes of clarity, Sanofi will have no obligation
whatsoever to [***] or [***] into [***]
to [***] , any [***] Technology to Micromet or
its Affiliates, or any [***] .
7.6.4 Sublicensing by
Micromet. Micromet will have the right to grant sublicenses in
any particular [***] Technology or [***] Technology (to
which Sanofi grants a license under Section 7.6.3) with the right to grant
further sublicenses under the license granted under Section 7.6.2 or Section
7.6.3, as applicable, to a [***] ; provided; however, in each
case and as a condition of such sublicense that: (a) Micromet’s
agreement with the particular [***] would permit the grant of a
reciprocal license to Sanofi of such [***] Technology under
substantially similar terms and conditions (including financial terms) in all
material respects (if treating such [***] Technology as technology
Controlled by the [***] and evaluating any restrictions on
licensing to Sanofi under the license agreement between Micromet and
the [***] ), (b) Micromet remains responsible to Sanofi for the
performance of Micromet’s obligations under this Agreement (either directly by
Micromet or by the [***] ), and (c) Micromet provides to Sanofi a
copy of such sublicense (and/or the applicable license agreement with
such [***] ) to the extent reasonably necessary to demonstrate the
satisfaction of the condition in subsection (a) above (with the identity of the
target and other confidential terms redacted) and a written confirmation by the
sublicensee that it agrees to be bound by the applicable terms and conditions
contained in this Agreement.
7.6.5 Grant Back of Licensed
Technology. Sanofi hereby grants to Micromet a nonexclusive
license of all rights in the Licensed Technology granted to Sanofi pursuant to
Section 7.1, solely to the extent necessary for Micromet to perform its
development obligations assigned to it under the Development Plan.
7.7
[***] Technology.
7.7.1 Each
Party covenants that it will not subject any [***] Technology to any
lien, encumbrance, security interest and/or other imposition that would effect
the other Party’s title or right to use the [***] Technology under
this Agreement or to sell or otherwise assign its rights thereunder without
consent of the other Party, except for any assignment of this Agreement
permitted under Section 17.2.
***
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
7.7.2 Sanofi
will not and will cause its Affiliates not to, grant any right, license or
interest or otherwise transfer its interest in any [***] Technology
to develop (including pre-clinical or clinical testing), manufacture, market,
sell, promote or otherwise commercialize any pharmaceutical product that
contains or comprises a [***] other than a [***]
..
7.8
Retained Rights; Covenant Not to
Practice.
7.8.1 Sanofi Intellectual Property
Rights. Except as and to the extent expressly granted in
Sections 7.6 and 13.1, nothing in this Agreement will grant to Micromet any
right, title or interest in and to the intellectual property rights of Sanofi or
its Affiliates (either expressly or by implication or
estoppel). Except as and to the extent expressly granted in Sections
7.6 and 13.1 and
subject to Section
7.9, Sanofi reserves all rights to the intellectual property rights Controlled
by Sanofi (including the [***] Technology, [***]
Technology and [***] Technology) and reserves the right to utilize or
allow Third Parties to practice such rights; provided that, during the term of
the [***] , Sanofi will not and will cause its Affiliates not to,
grant any right, license or interest or otherwise transfer any [***]
Technology to develop (including pre-clinical or clinical testing), manufacture,
market, sell, promote or otherwise commercialize any pharmaceutical product that
contains or comprises a [***] (other than Products or as
the Parties may agree in writing). Sanofi covenants that it will not
subject any [***] Technology or [***] Technology to which
Sanofi has granted Micromet a license under Section 7.6.2 or Section 7.6.3,
respectively, to any lien, encumbrance, security interest and/or other
imposition that would limit or restrict Micromet’s licenses under Sections 7.6
or 13.1.
7.8.2 Micromet Intellectual Property
Rights. Except as and to the extent expressly granted in Sections 7.1,
7.3 and Section 7.4, nothing in this Agreement will grant to Sanofi any right,
title or interest in and to the intellectual property rights of Micromet or its
Affiliates (either expressly or by implication or estoppel). Except
as and to the extent expressly granted to Sanofi in Sections 7.1, 7.3 and
Section 7.4 or the
terms of Section 7.9, Micromet reserves all rights to the intellectual property
Controlled by Micromet and its Affiliates (including the [***]
Technology and [***] Technology) and reserves the right to utilize or
allow Third Parties to practice such rights.
7.8.3 Limitation on Licensed
Rights. Sanofi hereby covenants and agrees not to use or
practice any [***] Technology or any [***] Patent, nor
cause or authorize any Affiliate or Third Party to use or practice any Licensed
Technology or Collaboration Product Patent, other than as expressly permitted by
Sections 7.1, 7.3 and Section 7.4 of this Agreement. Micromet hereby
covenants and agrees not to use or practice any [***] Technology
or [***] Technology nor cause or authorize any Affiliate or Third
Party to use or practice any [***] Technology or [***]
Technology other than as expressly permitted by Sections 7.6 and 13.1 in this
Agreement. In addition, Micromet hereby covenants and agrees not to
use or practice or license [***] Technology for the development,
manufacture or commercialization of a Product, except as required for Micromet
to perform its obligations 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
7.9
Exclusivity.
7.9.1 During
the Term, each
Party will not, and will cause its Affiliates not to, either directly or through
any Third Party, develop (through pre-clinical or clinical testing),
manufacture, market, sell, promote or otherwise commercialize, a pharmaceutical
product (other than a Product developed or Commercialized under this Agreement)
containing or comprising an Antibody binding to the Collaboration Target (an
“
[***] Product”), nor grant any license or other rights to a
Third Party to conduct any of the foregoing.
7.9.2 In the
event that any Party undergoes a Change of Control resulting in such Party
Controlling an [***] Product, then the terms of Section
7.9.1 will not apply to in any way limit or restrict, by or on behalf of a Party
or its Affiliates, the research, development, use, manufacture, marketing, sale,
promotion or commercialization of any [***] Product that
as of the date of consummation of such Change of Control was Controlled by such
Third Party acquiror and was the subject of an ongoing research or development
program, or was being commercialized by such Third Party acquiror.
7.9.3
Subject to Section 7.9.2, in the event that a Party or any of its Affiliates
acquires all or substantially all of the assets of a Third Party (whether in a
Change of Control of such Third Party or otherwise) and in such transaction
obtains Control of an [***] Product that would result in a
violation of the terms of Section 7.9.1 with respect to a particular country,
then, the Party or its Affiliate will (i) notify the other Party in writing no
later than [***] ( [***] ) [***] after consummation of such
transaction, (ii) [***] of
such [***] Product in such country by an [***]
to a [***] of all of such Party’s and its Affiliate’s rights to
such [***] Product not later than [***] ( [***]
) [***] from acquisition of such [***] Product
(or in the case of Sanofi obtaining Control of an [***] Product,
Sanofi may terminate this Agreement in its entirety with [***] (
[***] ) [***] prior written notice within [***] ( [***] )
[***] following such Change in Control), and (iii) notify the other
Party in writing of such [***] .
8.
|
Fees
and Payments
|
8.1 Initial Fees. In
consideration of the rights and licenses granted to Sanofi hereunder, no later
than ten (10) Business Days after the Effective Date, Sanofi will pay to
Micromet (a) a non-refundable, non-creditable initial license fee in the amount
of Five Million Two Hundred Fifty Thousand Euros (€5,250,000), and (b) an
advance payment of Micromet Development Expenses, in an amount equal to Two
Million Seven Hundred Fifty Thousand Euros (€2,750,000), which amount will be
credited towards Micromet FTE Costs to be reimbursed by Sanofi pursuant to
Section 8.2.
***
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 Payment of Micromet Development
Expenses. As set forth in Section 3.1.1 above, the Development
Plan will include a budget of Micromet Development Expenses to be
incurred. Sanofi will be responsible for all costs incurred by the
Parties after the Effective Date in the development of the
Products. Sanofi will pay Micromet for Micromet Development Expenses
in the manner set forth in this Section 8.2, provided that such Micromet
Development Expenses are incurred per the budget for such activities included in
the Development Plan as approved by the JSC and do not [***] of
the [***] for the activities during the applicable
Calendar Quarter. Micromet will provide an invoice to Sanofi promptly
following the beginning of each Calendar Quarter that details the Micromet
Development Expenses expected to be incurred by it during such Calendar
Quarter. Sanofi will make a payment to Micromet of such invoiced
amount within [***] ( [***] ) [***] following receipt
thereof. Within [***] ( [***] ) [***] following
the end of each Calendar Quarter, Micromet will provide Sanofi with a reports
containing a detailed account of activities actually performed and Micromet’s
Development Expenses actually incurred during such Calendar
Quarter. Such report will specify in reasonable detail (as agreed
with Sanofi) all Micromet Development Expenses during such Calendar Quarter and
will be accompanied by invoices, and/or such other appropriate supporting
documentation as may be required by Sanofi. The Parties will work
together to reconcile, in a timely fashion, the Micromet Development Expenses
set forth in the reports presented by Micromet with Sanofi’s payments for such
quarter. If the Parties determine that such payments exceed
Micromet’s reported Micromet Development Expenses, then the amount of such
excess will be credited against the next payment of Micromet Development
Expenses by Sanofi hereunder (or, if no such payment is anticipated, refunded by
Micromet to Sanofi within [***] ( [***]
) [***] of such determination). If the Parties
determine that Micromet’s reported Micromet Development Expenses exceed the
amount paid by Sanofi but such excess does not rise to the level of a Cost
Overrun (as defined below), then Sanofi will pay the excess amount to Micromet
together with amounts paid under the next Calendar Quarter invoice (or, if no
such payment is anticipated, paid by Sanofi to Micromet within [***]
( [***] ) [***] of such determination). Micromet will
report to Sanofi Micromet Development Expenses incurred by it for comparison
against such invoices and the Development Plan, on a line item basis (e.g.,
budgeted Micromet FTE Costs and actual out-of-pocket cost). The
Parties will seek to resolve any questions related to such accounting statements
within [***] ( [***] ) [***] following receipt by Sanofi
of Micromet’ report hereunder. Sanofi will have the right at
reasonable times and upon reasonable prior notice to audit Micromet’ records as
provided in Section 9.5.2 to confirm the accuracy of Micromet’ costs and reports
with respect to Micromet Development Expenses under this
Agreement. If Micromet anticipates that any Micromet Development
Expenses may exceed an amount equal to [***] of the [***]
for the [***] as [***] in
the [***] (such excess, a “Cost Overrun”), then Micromet
will give notice to Sanofi’s Alliance Manager of such anticipated Cost Overrun,
and Sanofi will in good faith (in consultation with Micromet) decide to modify
the Development Plan to reduce the costs appropriately and/or to increase the
budget for such tasks so that there is no longer a Cost Overrun.
8.3 Development
Milestones. Sanofi will pay Micromet each of the
non-refundable, non-creditable payments in the amounts set forth on Exhibit F attached
hereto within fifteen ( [***] ) [***] after the first occurrence of
the corresponding event described on such exhibit with respect to each
Product.
8.4 Royalties.
8.4.1 Royalty
Rates. Within [***] ( [***] ) [***] of
the end of each Calendar Quarter during the Term during which there were Net
Sales of a Product in the Territory, Sanofi will pay to Micromet a royalty equal
to:
***
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)
[***] percent ( [***] %) of the annual, worldwide, aggregate Net
Sales less than € [***] of such Product;
(b)
[***] percent ( [***] %) of the annual, worldwide, aggregate Net
Sales equal to or greater than € [***] and less than €
[***] of such Product; and
(c)
[***] percent ( [***] %) of the annual, worldwide, aggregate Net
Sales greater than € [***] .
By way of
example, if, during any calendar year during the Royalty Term, the amount of Net
Sales of a Product is € [***] , Micromet will receive [***] % of €
[***] + [***] % of € [***] + [***] %
of € [***] .
8.4.2 Royalty
Term. Royalties due under the preceding Section 8.4.1 will
commence upon First Commercial Sale of a Product in a particular country in the
Territory and will expire on a country-by-country basis upon the later of: (i)
the [***] of the [***] of any [***] within
the [***] or any [***] that [***]
a [***] or the [***] of a [***] , by the sale of the
Product in such country, or (ii) [***] ( [***] ) [***] from the First
Commercial Sale of such Product in such country.
8.4.3 Reduction of Royalty for
a [***] Product. The royalty rates set
forth in Section 8.4.1 applicable to a particular Product and particular country
will be reduced in accordance with the table below in the event that
a [***] the [***] of a [***] and the
sales of the Product in any Calendar Quarter [***] by the
applicable [***] (defined below) relative to the Calendar
Quarter immediately preceding the [***] of
the [***] and for so long as
the [***] [***] apply in the applicable
country. For purposes of this Section 8.4.3, the “ [***] ”
for any particular Calendar Quarter (following first commercial sale of
a [***] in such country) means
the [***] (expressed as a percentage) obtained
by [***] (A) the [***] obtained
by [***] the [***] of the Product in such
country for such applicable Calendar Quarter from the [***] of
the [***] in such [***] for the Calendar
Quarter immediately prior to [***] of the [***] in
such [***] by (B) the [***] [***] of
the [***] in such [***] for the Calendar
Quarter prior to [***] of the [***] in
such [***] . Once the
applicable [***] has been attained for a particular
country for a Calendar Quarter, then the royalty rates set forth in Section
8.4.1. for the Product in such applicable country will be [***] in
accordance with the table below commencing on the next Calendar Quarter for so
long as the applicable [***] continues to [***]
.. Notwithstanding anything in this Section 8.4.3,
no [***] will be triggered under this Section 8.4.3 for
a [***] which [***] its Affiliates or
sublicensees either [***] or [***] has [***]
a [***] to [***] the [***] ,
or [***] , its [***] or [***] have
any [***] in the [***] of such [***]
.. In the event that the royalty obligation to Micromet
is [***] by [***] of this Section 8.4, then
the [***] will be [***] as described
below.
***
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 [***]
|
Applicable [***]
|
Less
than [***] %
|
[***]
|
[***]
%
|
Greater
than or equal to [***] % but less than [***]
%
|
[***]
%
|
[***]
%
|
Greater
than or equal to [***] % but less than [***]
%
|
[***]
%
|
[***]
%
|
8.5
Payments
under [***] .
8.5.1 Sanofi
will be responsible for the payment obligations that are incurred after the
Effective Date to [***] under the agreement listed in Exhibit G-1; provided
that if Micromet is a party to the agreement listed in Exhibit G-1, then
Sanofi will not be required to pay [***] directly but will instead
reimburse Micromet for any payment obligations thereunder. Except as
set forth in Section 8.5.2 below, Sanofi will be responsible for the payments
that become due under any agreements under which Sanofi obtains a license or
otherwise acquires rights to intellectual property that is necessary or useful
for the development, manufacture, storage, handling, use, Commercialization or
importation of Products.
8.5.2
Micromet will be responsible for the payments made prior to the Effective Date
or that become due after the Effective Date to the licensors or assignors under
the agreements listed in Exhibit
G-2. In the event that the JSC (or Sanofi in consultation with
Micromet if the JSC does not exist) reasonably determines that a license is
necessary to avoid the risk of infringing Third Party Patents or Know-How
related to [***] of [***] to
the [***] (or [***] of [***]
such [***] ) (such Patents or Know-How, “Additional Third Party IP”),
then the JSC (or Sanofi in consultation with Micromet if the JSC does not exist)
will determine the manner in which such Additional Third Party IP will be
licensed, including the Party that should obtain the license. The
Party selected to obtain such license will use Commercially Reasonable Efforts
to negotiate, in consultation with the other Party, a license to such Third
Party IP and to present such license for review and approval by the JSC (or
Sanofi in consultation with Micromet if the JSC does not exist). The
Parties will [***] all payments due under such agreements
in respect of the license of the Additional Third Party IP (such payments,
“Third Party Payments”),
subject to Section 8.5.3. With respect to any non-royalty Third Party
Payments, [***] will pay directly to the Third Party both
its share and [***] share of any such non-royalty Third
Party Payments ( [***] total share, the “Advanced Amount”) when due (or
reimburse [***] , if [***] is the licensing
Party). [***] will [***]
the [***] by [***] the [***]
to [***] upon BLA submission and/or BLA approval (each as
described in Exhibit
F) in each case subject to the [***] (defined
below) (and the balance of the [***] will be [***]
the [***] to [***] under Section 8.2 subject to
the [***] ). Third Party Payments in the form of a royalty
will be [***] subject to
the [***] and the terms of Section 8.5.3.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Notwithstanding
the foregoing, in no event will any payments made by or on behalf of Micromet to
Third Parties under this Section 8.5.2, considered in the
aggregate, [***] the [***] received by Micromet
hereunder on Net Sales of Product to [***] than
the [***] or [***] the [***]
by [***] upon first BLA submission and/or BLA approval
(described in Exhibit
F) by more than [***] ( [***] %) of the amounts
thereof (the “ [***] ”).
Any additional payments due to Third Parties on account of the development,
manufacture, storage, handling, use, Commercialization or importation of
Products by Sanofi, its Affiliates or sublicensees will be [***]
by [***] . For the avoidance of doubt, for so long as the
applicable [***] is [***] ) pursuant to Section
8.4.3, then Sanofi will make all payments to Third Parties under agreements
under which either party has obtained a license, sublicense, assignment or other
right to Patents or Know-How relating to the Product, including all Third Party
Payments. In the event that either Party determines that
the [***] is [***] than
the [***] for any Calendar Quarter, then such Party will
notify the other Party and if both Parties agree to such determination, then
Sanofi will be obligated to pay to Micromet the amount necessary in such
Calendar Quarter to provide Micromet with the amount due under
the [***] .
8.5.3 In the
event Micromet is bound to a Third Party for payments described in this Section
8.5 for which Sanofi is responsible, then Micromet will make such payment
directly to the Third Party in accordance with the terms of such Third Party
agreement, and Sanofi will be obligated to make such payments directly to
Micromet in advance of the date such payments are due to the Third
Party. Promptly following the Effective Date, the Parties will
establish a mutually acceptable process to facilitate the timely and accurate
payment to Micromet of such Third Party payments.
8.5.4
Micromet will duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and does 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 Sanofi may reasonably request for
Sanofi to operate under the agreements listed in Exhibit
G-2.
9.
|
Payment
Terms
|
9.1 Payment Method;
Interest. All undisputed amounts due hereunder to Micromet will be
paid in Euros, within [***] ( [***]
) [***] upon receipt of corresponding invoices, by wire
transfer in immediately available funds to an account designated by
Micromet. 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) [***] ( [***] ) percentage
points 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 Tax Matters.
9.2.1 Deduction or Withholding
Tax. All payments required under this Agreement will be
without any deduction or withholding for, or on account of, any tax or similar
governmental charge imposed by any jurisdiction, unless such deduction or
withholding is required by applicable laws or regulation. If Sanofi is required
to deduct or withhold under Applicable Law amounts payable to Micromet, Sanofi
will (a) promptly notify Micromet of such requirement, (b) pay to the relevant
authorities the full amount required to be deducted or withheld, and (c) forward
to Micromet within [***] ( [***] ) [***] an official
report (or certified copy) or other documentation evidencing such payment to
such authorities.
***
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
9.2.2 Withholding Taxes Resulting From
Sanofi Action. If Sanofi (or Sanofi’s Affiliates or
successors) is required to make a payment to Micromet subject to a deduction or
withholding of tax, then (A) if such deduction or withholding of tax obligation
arises as a result of any action taken by Sanofi or Sanofi’s Affiliates or
successors, including a change of domicile, any assignment or transfer of all or
a portion of this Agreement as permitted under this Agreement or any sublicense
of rights or obligations hereunder to an Affiliate or Third Party and such
action has the effect of increasing the amount of tax deducted or
withheld (a “Sanofi Withholding
Tax Action”), then notwithstanding Section 9.2.1, the payment by Sanofi
(in respect of which such deduction or withholding of tax is required to be
made) will be increased by the amount necessary (the “Additional Amounts”) to ensure
that Micromet receives an amount equal to the same amount that it would have
received had no Sanofi Withholding Tax Action occurred, and (B) the Additional
Amounts will be deducted and withheld by Sanofi from the increased payment made
by Sanofi to Micromet. The Additional Amounts, along with any other
tax deducted and withheld from the payment made by Sanofi, will be timely
remitted to the proper tax authority for the account of Micromet in accordance
with applicable Law and Sanofi will provide Micromet with evidence of such
remittance in accordance with Section 9.2.3.
9.2.3 Cooperation between Sanofi and
Micromet. Sanofi and Micromet will reasonably cooperate in
completing and filing documents required under the provisions of any applicable
tax laws or under any other applicable law in connection with the making of any
required tax payment or withholding payment, or in connection with any claim to
a refund of or credit for any such payment. Notably, prior to any
first payment by Sanofi to Micromet in a calendar year, Micromet will provide
Sanofi with any relevant form required by the relevant tax authorities in order
for Micromet to attest its fiscal residence and accordingly obtain the
application of the reduced withholding tax rate or the exemption of withholding
tax rate, according to the relevant bilateral convention for the prevention of
double taxation. At the request of Micromet, Sanofi will forward to
Micromet the applicable forms for fulfillment. In the event Micromet fails to
return to Sanofi such forms duly completed and signed before a payment date,
Sanofi will declare and pay withholding tax at the local common law rate
applicable to the payments, and such tax will be deducted from the corresponding
payment by Sanofi to Micromet. Sanofi will remit the withholding tax to the
proper tax authority and proof of payment of such tax will be secured and sent
to Micromet as evidence of such payment within ( [***]
) [***] of such payment.
9.3
Reports. Sanofi
will accompany each payment of royalties under this Agreement with a report
containing a detailed and itemized calculation of Net Sales of a Product in the
Territory during the preceding Calendar Quarter, including a description of the
dates and territories in which Product sales were made.
9.4
Currency
Conversion. For any currency conversion required in
determining the amount of royalties due the amount of Net Sales in any foreign
currency will be computed by converting such amount into Euros, such conversion
will be made in a manner consistent with Sanofi’s normal practices used to
prepare its audited financial statements for internal and external reporting
purposes, which uses a widely accepted source of published exchange
rates. Except as provided in Section 9.2, all payments due
under this Agreement will be paid in full without deduction for any withholding
or value added tax.
***
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
9.5 Records Retention;
Audit.
9.5.1 Record
Retention. Each Party will maintain complete and accurate
books, records and accounts used for the determination of (a) any Micromet
Development Expenses that Sanofi is required to reimburse under this Agreement
and (b) 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 such Party until [***] ( [***] ) [***] after
the end of the period to which such books, records and accounts
pertain.
9.5.2 Audit. Each Party
will have the right to have an independent certified public accounting firm of
internationally recognized standing, reasonably acceptable to the other Party,
have access during normal business hours, and upon reasonable prior written
notice, to such of the records of the other Party and its Affiliates as may be
reasonably necessary to verify the accuracy of Micromet Development Expenses or
Net Sales for any Calendar Quarter ending not more than [***] ( [***]
) [***] prior to the date of such request; provided, however, that no Party will
have the right to conduct more than one such audit in any [***]
.. The accounting firm will disclose to the Parties only whether the
Micromet Development Expenses or 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 auditing Party’s favor of more
than [***] percent ( [***] %), 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.
9.5.3 Payment of Additional
Amounts. If, based on the results of any audit, additional
payments are owed Micromet under this Agreement, then Sanofi will make such
additional payments promptly after the accounting firm’s written report is
delivered to both Parties. If, based on the results of any audit, any
payments made by Sanofi to Micromet exceeded the amounts due and payable under
this Agreement, then Micromet will return such excess to Sanofi promptly after
the accounting firm’s written report is delivered to both Parties.
9.5.4 Confidentiality. Each
Party will treat all information subject to review under this Section 9.5 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.
***
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.
|
Confidentiality
|
10.1 Definition. During
the Term and subject to the terms and conditions of this Agreement, a Party (the
“Disclosing Party”) may
communicate to the other Party (the “Receiving Party”) information
in connection with this Agreement or the performance of its obligations under
this Agreement, including, any information in reports provided pursuant to this
Agreement, scientific and manufacturing information and plans, 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 (collectively, “Confidential
Information”). 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. Confidential Information also includes any information
disclosed prior to the Effective Date pursuant to that certain Confidentiality
Agreement between the Parties dated [***] .
10.2 Exclusions. Notwithstanding
the foregoing, any information of a Party will not be deemed Confidential
Information with respect to the Receiving Party for purposes of this Agreement
if such information:
10.2.1 was already known
or available to the Receiving Party or its Affiliates at the time of disclosure
to the Receiving Party, other than under an obligation of confidentiality or
non-use to the Disclosing Party;
10.2.2 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 Receiving Party;
10.2.3 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 Receiving Party, other than through the Receiving Party’s
breach of its obligations under this Section 10;
10.2.4 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 Disclosing Party not to
disclose such information to others; or
10.2.5 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 of the Disclosing Party.
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 will keep completely
confidential and will not publish or otherwise disclose any Confidential
Information of the other Party or its Affiliates. Neither Party will
use any Confidential Information of the other Party without such other Party’s
consent, except as expressly permitted by this Agreement.
10.4 Authorized Use and
Disclosure. Each Party may use and disclose Confidential
Information of the other Party to the extent that such use and disclosure
is:
***
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
10.4.1 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 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;
10.4.2 otherwise
required by applicable laws, regulations or the rules of any nationally
recognized security exchange; provided, however, that the Disclosing
Party will provide such other Party with notice of such disclosure in advance
thereof to the extent practicable;
10.4.3 made by such
Party to the regulatory authorities as required in connection with any filing of
INDs, 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;
10.4.4 made by such
Party, in connection with the performance of this Agreement or a grant to a
Third Party of a license or right hereunder to the extent expressly permitted by
this Agreement, on a need-to-know basis to Affiliates, research parties,
employees, consultants, licensees, 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;
10.4.5 made by such
Party to existing or potential acquirers or merger candidates, investment
bankers or existing or potential investors, including venture capital firms or
other financial institutions, 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
10.4.6 made in a patent
application expressly permitted to be filed under Section 6.
11.
|
Public
Communications
|
11.1 General
Provisions. The Parties will cooperate with respect to the
timing and content of communications with the public regarding the development
and marketing of a Product, subject to the provisions of this Section
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
11.2 Press Releases. The
Parties agree that the public announcement of the execution of this Agreement
will be made by individual press releases issued by each Party and will not be
made in a joint press release. Furthermore, each such press release
will be substantially in the form of the press releases attached as Exhibits H-1 and
H-2. Any
subsequent press releases by Micromet relating to this Agreement or to the
performance hereunder, will first be reviewed and approved by Sanofi; provided, however, that (i)
any disclosure which is required by law, including disclosures required by the
U.S. Securities and Exchange Commission or made pursuant to the requirements of
the national securities exchange or other stock market on which Micromet’s
securities are traded, as advised by Micromet’s counsel, (ii) the receipt by
Micromet of any milestone payments or the achievement of any material clinical
development or regulatory activities for the Product, in each case may be made
without the prior consent of Sanofi, although Sanofi will be given prompt notice
of any such disclosure and to the extent practicable will provide Sanofi an
opportunity to comment on the proposed disclosure. Any subsequent
press releases by Sanofi relating to this Agreement or to the performance
hereunder, will, to the extent practicable, be reviewed by Micromet with an
opportunity to comment on the proposed disclosure.
11.3 Publications and
Presentations. At least [***] ( [***] )
[***] prior to submission of any material related to the research or
development activities hereunder for publication in print or electronic media or
presentation at conferences, the submitting Party will provide to the other
Party a draft of such material for its review and comment. The
receiving Party will provide any comments to the submitting Party
within [***] ( [***] ) [***] of receipt of such materials,
and the submitting Party will review and consider in good faith any comments
provided by the other Party. In addition, any information determined
by the other Party to be its Confidential Information must be removed upon
request of the other Party. If requested in writing by the other
Party, the submitting Party will withhold material from submission for
publication or presentation for an additional [***] (
[***] ) [***] to allow for the filing of a patent application or the
taking of such measures to establish and preserve proprietary rights in the
information in the material being submitted for publication or
presentation.
11.4 Previous
Disclosures. A Party may publicly disclose without regard to
the requirements of this Section 11 any information that was previously
disclosed in compliance with such requirements.
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 expiration and satisfaction of all
payment obligations hereunder for Products, unless earlier terminated as
provided in this Agreement.
12.2 Termination
for Material Breach.
12.2.1 If a Party (the
“Breaching Party”)
commits a material breach of this Agreement, the other Party (the “Non-Breaching Party”) may give
to the Breaching Party written notice specifying the nature of the material
breach and requiring the Breaching Party to make good or otherwise cure such
material breach.
12.2.2 If such material
breach is not cured within [***] ( [***] ) [***] after the
receipt of notice pursuant to Section 12.2.1 above (or within [***] (
[***] ) [***] notice in the event such breach is solely based upon
the breaching Party’s failure to pay any amounts due hereunder), the
Non-Breaching Party will have the right, on written notice to the Breaching
Party, to terminate this Agreement without prejudice to any of its other rights
and remedies conferred on it by this Agreement or by
law. Notwithstanding the foregoing provisions of this Section 12.2,
if a material breach (other than for non-payment) cannot be cured within the
stated period and the Breaching Party uses diligent good faith efforts to cure
such breach, the respective [***] ( [***]
) [***] cure period will be extended for so long as such
diligent efforts continue for up to an additional [***] ( [***] )
[***] from the expiry of the initial [***] ( [***] )
[***] cure period.
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
12.3 Termination at
Will. Sanofi may terminate this Agreement in its entirety with
ninety (90) days prior written notice to Micromet during the following time
periods: (i) for a period of [***] ( [***]
) [***] after the later of the two (2) year anniversary of
the Effective Date if a [***] has not [***] by
the [***] pursuant to [***] or such [***] if
any, as may be set forth in an [***] to [***]
an [***] ; (ii) [***] ( [***] )
[***] following [***] receipt of the [***] for
the [***] ; (iii) the period from the [***] of
the [***] in the [***] of
the [***] (as specified in the
then-current [***] for such [***] ) and
ending [***] ( [***] ) days following the receipt of
the [***] for such [***] ; (iv) the period from
the [***] of the [***] in the [***] of
the [***] (as specified in the
then-current [***] for such [***] ) and
ending [***] ( [***] ) days following the receipt of
the [***] , and (v) anytime after [***]
and [***] after the Effective Date, if an [***]
for a [***] was not [***] prior to such
date. In addition to the foregoing, at anytime after the receipt of
the first preliminary Phase 2 Trial report, Sanofi may terminate this Agreement
in its entirety with at least one hundred eighty (180) days’ prior written
notice to Micromet.
12.4 Termination of Collaboration by
Sanofi for Material Breach. If Micromet is in material breach
of this Agreement, then Sanofi may, instead of terminating the Agreement
pursuant to Section 12.2, elect to continue this Agreement in full force and
effect, except to terminate certain portions of the Agreement as further
described in this Section 12.4. In the event Sanofi notifies Micromet
of a material breach of this Agreement pursuant to Section 12.2.1 (a “Material Breach Notice”), then
Micromet may initiate the dispute resolution procedures of Section
17.4. If Micromet does not initiate arbitration
within [***] ( [***] ) [***] after receipt of the Material
Breach Notice or if the arbitration conducted under Section 17.4 results in a
final determination that Micromet has committed a material breach and that
Micromet has failed to cure such breach pursuant to Section 12.2.2, then Sanofi
will have the right to immediately terminate upon written notice (in whole or in
part, as determined by Sanofi and specified in the written notice) Sections 2
and 3 of this Agreement (other than Sections 3.3). Upon such partial
termination (i) Sanofi will assume full control over the development of Product,
(ii) all committees, including the JSC will be disbanded, (iii) Sanofi will have
no further obligation to send Micromet any reports or updates regarding the
Product other than to provide Micromet with an annual summary of its development
progress during such year and proposed annual sales forecast following
Regulatory Approval of the Product and the reports described in Section 9.3 and
(iv) Micromet will assign to Sanofi (or at the discretion of Sanofi, terminate)
any contracts entered into with any Third Parties in connection with the
development of the Product to the extent permitted to do so and thereafter
Sanofi will have no further obligation whatsoever to reimburse Micromet for any
Micromet Development Expenses that are incurred after the effective date of
termination. In addition to the rights described above, Sanofi will
have the right to set-off, against any payments or other amounts due to Micromet
by Sanofi but not yet paid by Sanofi, all direct damages established in the
arbitration under Section 17.4 (or as agreed in writing by Micromet) suffered by
Sanofi, based on the material breach that gave rise to Sanofi’s election under
this Section 12.4. If Sanofi elects this set-off remedy, then such
remedy will be exclusive and in lieu of all other remedies that may be available
to Sanofi for such material breach.
***
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.
|
Effects
of Termination
|
13.1 Program Transfer upon Termination.
Upon any termination of this Agreement (excluding any partial termination
under Section 12.4), Sanofi will, at [***] to Micromet, transfer or
assign to Micromet or its designee all materials, documentation, processes,
Regulatory Filings, licenses, and other items as are reasonably necessary for
Micromet to continue the development of a Product (such transfer, including the
actions listed below hereafter referred to as the “Program
Transfer”). Without limiting the generality of the foregoing,
and to the extent requested by Micromet, Sanofi hereby agrees (effective only
upon such termination) and will:
(a) transfer
to Micromet all Know-How, data, materials, reports and information in Sanofi’s
possession or control that were developed under the Agreement or in winding down
the clinical trials and other development activities relating to Products, and
treat the foregoing as “Confidential Information” of Micromet under Section 10;
provided that Sanofi will be allowed to retain any such materials that a
Regulatory Authority requires Sanofi to retain;
(b) transfer
to Micromet all Regulatory Filings and Marketing Approvals relating to such
Product;
(c) transfer
to Micromet the management and continued performance of any clinical trials for
such Product ongoing as of the effective date of such termination;
(d) transfer
to Micromet all clinical and commercial supplies of such Product in Sanofi’s
possession or control;
(e) complete
all manufacturing activities relating to such Product that are ongoing as of the
effective date of such termination, and upon Micromet’s request, supply Micromet
with such Product for clinical development or commercial sale but in no event
longer than [***] ( [***] ) [***] ; provided, that Micromet will
reimburse Sanofi for [***] % of the reasonable and documented costs
incurred by Sanofi in such manufacturing activities performed by or on behalf of
Sanofi;
(f) transfer
the manufacturing process for the Product to Micromet or its designee (which
will be designated by Micromet as soon as reasonably practical but in no event
later than [***] ( [***] ) [***] following the effective
date of the termination of this Agreement);
(g) assign
to Micromet any or all agreements between Sanofi and Third Parties, relating
solely to the development or manufacture of such Product, to the extent
permissible under the terms of such agreements;
***
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) assign
to Micromet its entire right, title and interest in and to any [***]
;
(i) assign
to Micromet its entire right, title and interest in and to any trademarks, trade
dress, logos, slogans, designs and copyrights, in each case relating solely to
such Product, including any registrations for the foregoing;
(j) grant
to Micromet a worldwide, fully-paid, transferrable, irrevocable, exclusive
license (with the right to grant and authorize the further grant of sublicenses)
under any [***] Technology, Sanofi’s interest in
any [***] Technology and a worldwide, royalty bearing,
transferrable, irrevocable, exclusive license (with the right to grant and
authorize the further grant of sublicenses) under
any [***] Technology
and [***] Technology in each case as and to the extent
incorporated or used in the Product or otherwise necessary to research, develop,
make, use, offer for sale, sell, import, export and otherwise commercialize the
Product. Promptly following the delivery of a termination notice by a
Party under this Agreement, the Parties will negotiate in good faith
the [***] on [***] of the [***] for
the foregoing license to [***] Technology
and [***] Technology. If the Parties fail to
reach an agreement on the terms and conditions of the [***] to
such [***] to the [***] Technology
and [***] Technology within [***] ( [***] )
[***] of the commencement of such negotiations, the procedure
described in Section 17.4 will apply and Sanofi covenants during the pendency of
such proceedings not to xxx Micromet, its Affiliates or any third party
sublicensee under any Sanofi Additional Collaboration Technology or Sanofi
Independent Technology in connection with any research, development,
manufacture, use sale, import, export or other commercialization of the Product;
and
(k) grant
to Micromet a worldwide, fully-paid, transferrable, irrevocable, non-exclusive
license (with the right to grant and authorize the further grant of sublicenses)
under any [***] Technology and Sanofi’s interest in
any [***] Technology to research, develop, make, use offer
for sale, sell, import, export or otherwise commercialize any Micromet
Product.
13.2 Funding during Notice Period and
Payment of Committed Expenses. During the period from
providing a notice of termination pursuant to Section 12.3 through the
termination of the Agreement, Sanofi will continue to perform the Development
Plan and reimburse Micromet for its Micromet Development Expenses in accordance
with the terms of this Agreement. In addition, Sanofi will pay to
Micromet (i) upon termination of this Agreement pursuant to Section 12.3 and for
a period [***] thereafter, amounts that Micromet is
obligated to pay to Third Parties based on legally binding commitments made in
accordance with the Development Plan prior to the date of such notice of
termination and (ii) upon termination of this Agreement pursuant to Section 12.3
any non-cancellable amounts that Micromet is obligated to pay to Third Parties
based on legally binding commitments made in accordance with the Development
Plan prior to the date of such notice of termination in the event Micromet
determines not to continue the development or commercialization of the
Product. Micromet will inform Sanofi prior to entering into any
agreement with a Third Party covered under this Section 13.2 that would include
payment obligations that are not cancellable with [***] ( [***] )
[***] 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.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
13.3 Termination of
Licenses. Upon any termination of this Agreement, all rights
and licenses granted by Micromet to Sanofi hereunder will
terminate.
13.4 Rights Upon
Expiration. Upon expiration of this Agreement pursuant to
Section 12.1, Sanofi will have a non-exclusive, fully paid, royalty-free right
and license under the Licensed Technology to make, have made, use, sell, offer
for sale, and import Products then being Commercialized in the Territory in the
Field. Notwithstanding the foregoing, Sanofi will make any payments
under any [***] , the agreements listed in Exhibit G-1 and any
other payments due to Third Parties for any intellectual property rights
licensed to Sanofi pursuant to this Agreement, for
as long as such payments are due under such agreements, and Sanofi’s rights as a
licensee or sublicensee under such intellectual property rights will remain
subject to Sanofi’s compliance the payment and other terms thereof.
13.5 Accrued
Rights. Termination of this Agreement for any reason will be
without prejudice to any rights that will have accrued to the benefit of a Party
prior to the effective date of such termination. Such termination
will not relieve a Party from obligations that are expressly indicated to
survive the termination of this Agreement.
13.6 Survival. Sections
5.4, 5.6, 6.1, 6.2, 8 (with respect to any unpaid amounts due), 9, 10 (for the
period stated in Section 10.3), 13, 14, 16 and 17, together with any definitions
used or exhibits referenced therein, will survive any termination or expiration
of this Agreement.
14.
|
Indemnification
and Insurance
|
14.1 Indemnification of
Micromet. Sanofi will indemnify Micromet and its Affiliates,
and their respective directors, officers, and employees (each, a “Micromet Indemnitee”), and
defend and hold each of them harmless from and against any and all losses,
damages, liabilities, costs and expenses (including reasonable attorneys’ fees
and expenses) (collectively, “Losses”) arising in connection
with any and all claims, demands, lawsuits, or investigations by a Third Party
(each a “Third Party
Claim”) against a Micromet Indemnitee, to the extent caused by or arising
out of: (a) any breach by Sanofi of this Agreement, (b) the gross negligence or
willful misconduct on the part of Sanofi, its Affiliates, or Service Providers
in performing any activity contemplated by this Agreement, or (c) the
development, manufacture, use, handling, storage, supply, Commercialization or
other disposition of Product by Sanofi, its Affiliates or its/their
sublicensees.
14.2 Indemnification of
Sanofi. Micromet will indemnify Sanofi, its Affiliates, and
their respective directors, officers, and employees (each, a “Sanofi Indemnitee”), and
defend and hold each of them harmless from and against any and all Losses
arising in connection with any Third Party Claim against a Sanofi Indemnitee, to
the extent caused by or arising out of: (a) any breach by Micromet of this
Agreement; (b) the gross negligence or willful misconduct on the part
of Micromet, its Affiliates, or Service Providers in performing any activity
contemplated by this Agreement; (c) the performance of Micromet’s development
activities under the [***] , or (d) from the manufacture, use,
handling, storage, supply, sale or other disposition of Product by Micromet or
its Affiliates, or Service Providers, in each case, excluding any Losses to the
extent Sanofi has an obligation to indemnify Micromet and its Affiliates
pursuant to Section 14.1.
***
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
14.3 Notice of
Claim. All indemnification claims in respect of any Sanofi
Indemnitee or Micromet Indemnitee seeking indemnity under Sections 14.1 or 14.2
(collectively, the “Indemnitees” and each an
“Indemnitee”) will be
made solely by the corresponding Party (the “Indemnified Party”). The
Indemnified Party will give the indemnifying Party (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 or Section 14.2, 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). Together with the Indemnification Claim Notice, the
Indemnified Party will furnish promptly to the Indemnifying Party copies of all
notices and documents (including court papers) received by any Indemnitee in
connection with the Third Party Claim.
14.4 Control of
Defense. At its option, the Indemnifying Party may assume the
defense of any Third Party Claim subject to indemnification as provided for in
Sections 14.1 and 14.2 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 select and appoint the lead legal counsel for the defense
of 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, except as provided in
Section 14.5.
14.5 Right to Participate in
Defense. Without limiting Section 14.4, 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 (a) the employment thereof has
been specifically authorized by the Indemnifying Party in writing, or (b) the
Indemnifying Party has failed to assume the defense and employ counsel in
accordance with Section 14.4 (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
14.6 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, and as to which the Indemnifying Party
has 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. The Indemnifying Party will pay all amounts on behalf of the
Indemnified Party at or prior to the time of 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 14.4, 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 that has assumed the
defense of the Third Party Claim in accordance with Section 14.4 will not be
liable for any settlement or other disposition of a Loss by an Indemnitee that
is reached without the written consent of such Indemnifying
Party. Regardless of whether the Indemnifying Party chooses to
defend any Third Party Claim, no Indemnitee will admit any liability
with respect to, or settle, compromise or discharge, any Third Party Claim
without first offering to the Indemnifying Party the opportunity to assume the
defense of the Third Party Claim in accordance with Section 14.5.
14.7 Cooperation. If the
Indemnifying Party chooses to defend any Third Party Claim, the Indemnified
Party will, and will cause each other Indemnitee to, cooperate in the defense
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 the defense of
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. The
Indemnifying Party will reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection with such cooperation.
14.8 Expenses. Except as
provided above, the reasonable and verifiable costs and expenses, including fees
and disbursements of counsel, incurred by the Indemnified Party in connection
with any claim will be reimbursed on a Calendar Quarter basis by the
Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund
in the event the Indemnifying Party is ultimately held not to be obligated to
indemnify the Indemnified Party.
14.9 Insurance. During
the Term, each Party will have and maintain such types and amounts of liability
insurance including self-insurance as is normal and customary in the industry
generally for similarly situated parties, and will upon request provide the
other Party with a certificate 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:
15.1.1 Such Party (a)
has the corporate power and authority to enter into this Agreement and perform
its obligations hereunder, and (b) has taken all necessary corporate 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
15.1.2 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;
15.1.3 The execution and
delivery of this Agreement and the performance of such Party’s obligations
hereunder (a) do not conflict with or violate any requirement of any provision
of the articles of incorporation, bylaws or any similar instrument of such Party
in any material way, and (b) 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 Sanofi that, as of the Effective Date:
15.2.1 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.
15.2.2 Micromet is the
sole and exclusive owner of all right, title and interest in the Licensed
Technology or, as the case may be, has obtained licenses thereto.
15.2.3 To the knowledge
of Micromet’s officers and the head of Micromet’s Intellectual Property
department (i) Micromet has not received any written allegation from a Third
Party that any Patent within the [***] Technology is invalid or
unenforceable and (ii) no Patent within the [***] Technology is
subject to interference, reexamination, reissue, revocation, opposition, appeal
or other administrative proceedings.
15.2.4 [***] , to the
knowledge of Micromet’s officers and the head of Micromet’s Intellectual
Property department (i) the research and development activities of potential
Products as described in the Development Plan as of the Effective Date, and (ii)
the generation of BiTE Antibodies binding to the Collaboration Target and
manufacture for clinical purposes of such BiTE Antibodies as described in the
Development Plan as of the Effective Date and the composition or use of such
generated BiTE Antibodies in a Product is not claimed in any
published patent application (evaluating such patent application as of the
Effective Date as though it was issued with the claims as published as of the
Effective Date) or any issued Patent of a Third Party that is not sublicensed to
Sanofi under this Agreement as part
of [***] Technology.
15.2.5 Micromet has not
received, with respect to the Licensed Technology, any notice of infringement or
any written communication relating in any way to a possible infringement of any
Third Party patent rights by its activities prior to the Effective Date or the
activities of either Party contemplated by 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
15.2.6 Micromet has the
right and authority to grant the rights and licenses granted to Sanofi pursuant
to the terms and conditions of this Agreement, and Micromet has not granted any
right, license, or interest in, to, or under the Licensed Technology that is
inconsistent with the rights, licenses, and interests granted to Sanofi under
the terms and conditions of this Agreement.
15.2.7 Micromet has not
placed, and to Micromet’s knowledge there does not exist, upon the Licensed
Technology any encumbrance, charge or lien that would preclude Micromet from
granting the rights to Sanofi under this Agreement.
15.2.8 The Patents
listed on Exhibit
C represent all Patents within Micromet’s Control required or useful for
the development and Commercialization of a Product; provided that it will not be
a breach of this representation if any Patent was omitted from this Exhibit C and is
subsequently included on an revised Exhibit
C.
15.2.9 The Patents
listed on Exhibit
C have been filed and maintained in a manner consistent with its standard
practice in each applicable country in the Territory in which such Patents have
been filed and all applicable fees have been paid on or before the due date for
payment.
15.2.10 To Micromet’s
knowledge, all inventors of inventions claimed in the Patents listed on Exhibit C have
assigned, or have a contractual obligation to assign, their entire right, title
and interest in and to such inventions to Micromet and the inventors listed are
correct and there are no claims or assertions in writing regarding the
inventorship of such Patent Rights alleging that additional or alternative
inventors ought to be listed, except for the corrections listed on Exhibit
J.
15.2.11 To the knowledge
of Micromet’s officers, the option under Contract # [***] listed on
Exhibit G-1 is
in full force and effect and Micromet has not received any notice that such
option could not be exercised by Micromet in accordance with the terms
thereof.
15.3 Additional Representations and
Warranties of Sanofi. Sanofi hereby represents and warrants to Micromet
that, as of the Effective Date: Sanofi is a corporation duly
organized, validly existing and in good standing under the laws of France, 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.
15.4 Compliance. Each
Party will conduct its respective activities under this Agreement with respect
to a Product in good scientific manner, and in compliance in all material
respects with all requirements of Applicable Laws.
***
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.
|
Disclaimer;
Limitation of Liability
|
16.1 Disclaimer of
Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
SECTION 15, SANOFI 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 SANOFI AND MICROMET EACH SPECIFICALLY DISCLAIMS ANY OTHER
REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR
IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR
THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.
16.2 Limitation of
Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR LOST
PROFITS, 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
OBLIGATIONS TO THE OTHER PARTY UNDER SECTIONS 10 AND 14.
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, pandemics, quarantines, war, acts of terrorism, 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 ten (10) days
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 obligations under this Agreement without the
prior written consent of the other Party (which consent may be granted, withheld
or conditioned at such other Party’s sole and absolute discretion); 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 provided that such transfer and assignment will be effective for only
so long as such Affiliate remains an Affiliate, or (b) to any Third Party in
connection with a Change of Control of such Party. In addition, in
the event that in connection with any Change of Control of, or the acquisition
of a Third Party by Sanofi, a Governmental Authority requires the sale, transfer
or divestiture of Sanofi’s rights in and to a Product, then Sanofi may assign
this Agreement in whole or in part to a Third Party, within the [***]
( [***] ) [***] period following the closing of such Change of
Control or acquisition, subject to Micromet’s consent not to be unreasonably
withheld (it being understood that such consent may be withheld, among other
reasons, in the event such Third Party is developing or commercializing a
product that may be competitive with a Product); provided, however, that such consent
will not be required for any assignment of this Agreement to any person or
entity designated and approved by the Governmental Authority requiring such
sale, transfer or other divestiture of a Product. Any such assignment
will not be effective unless and until the relevant Affiliate assignee, Third
Party assignee or surviving entity assumes in writing all of the assigning
Party’s obligations under this Agreement. A copy of such written
assumption of obligations will be provided to the other Party upon
request. 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.
17.4
Governing Law;
Dispute Resolution.
17.4.1 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 New York, New York, United States of America, without giving effect
to any principles, statutory provisions or other rules of choice of law that
would require the application of the laws of a different country.
17.4.2 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
will, before initiating any proceedings pursuant to Section 17.4.3, 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 meet in person
at least once and 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
17.4.3 If a Dispute is
not resolved as provided in the preceding Section 17.4.2, whether before or
after termination of this Agreement, the Parties hereby agree that:
(a) if
the Parties fail to agree on the appropriate terms of a license to be granted
under Sections 7.3 or 13.1(j) then the procedures set forth on Exhibit I will apply;
and
(b) all
other Disputes will be resolved by final and binding arbitration conducted in
accordance with the terms of this Section 17.4.3. The arbitration
will be held in New York, New York, USA according to Rules of Arbitration of the
International Chamber of Commerce (“ICC”). The
arbitration will be conducted by a panel of three (3) arbitrators with
significant experience in the pharmaceutical industry, unless otherwise agreed
by the Parties, appointed in accordance with applicable ICC
rules. Any arbitration herewith will be conducted in the English
language to the maximum extent possible. The arbitrators will be
instructed not to award any punitive or special damages and will render a
written decision no later than [***] following the
selection of the arbitrator, including a basis for any damages awarded and a
statement of how the damages were calculated. Any award will be
promptly paid in Euros free of any tax, deduction or offset. Each
Party agrees to abide by the award rendered in any arbitration conducted
pursuant to this Section 17. With respect to money damages, nothing
contained herein will be construed to permit the arbitrator or any court or any
other forum to award punitive or exemplary damages. By entering into
this agreement to arbitrate, the Parties expressly waive any claim for punitive
or exemplary damages. Each Party will pay its legal fees and costs
related to the arbitration (including witness and expert
fees). Judgment on the award so rendered will be final and may be
entered in any court having jurisdiction thereof.
17.4.4 Nothing in this
Section 17 will preclude either Party from seeking equitable relief or interim
or provisional relief from a court of competent jurisdiction, including a
temporary restraining order, preliminary injunction or other interim equitable
relief, concerning a dispute either prior to or during any arbitration if
necessary to protect the interests of such Party or to preserve the status quo
pending the arbitration proceeding.
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:
If to Sanofi, to:
xxxxxx-xxxxxxx
000,
xxxxxx xx Xxxxxx
75635
Paris, Cedex 13
France
Attention:
Senior Vice President – Business Development
Facsimile:
00.0.00.00.00.00
***
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
with a
copy to:
sanofi-aventis
000,
xxxxxx xx Xxxxxx
00000
Xxxxx, Cedex 13
France
Attention:
Senior Vice President & General Counsel
Facsimile:
00.0.00.00.00.00
If to
Micromet, to:
Micromet
AG
Xxxxxxxxxxxxx.
0
00000
Xxxxxx
Xxxxxxx
Attention:
Head of Business Development
Facsimile:
xx00 00 000 000 000
with a
copy to:
0000
Xxxxxxxxx Xxxxxxxxx
Xxxxx
000
Xxxxxxxx,
XX 00000
Attention:
General Counsel
Facsimile:
x0-000-000-0000
or to
such other address as the Party to whom notice is to be given may have furnished
to the other Party in writing. Any such communication will be deemed
to have been given (i) when delivered, if personally delivered or sent by
facsimile on the same day if a Business Day and if not on the next Business Day
following delivery, 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 obligations, in
due course, under the terms of this Agreement.
17.6
Entire Agreement;
Modifications. This Agreement and all Exhibits and Schedules
hereto (including the diligence summary delivered by Micromet as of the
Effective Date) 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,
including the Confidentiality Agreement between the Parties
dated [***] . Each Party confirms that it is not relying
on any representations or warranties of the other Party except those that are
expressly made in this Agreement. No amendment or modification of
this Agreement will be binding upon the Parties unless made in writing and duly
executed by authorized representatives of both 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
17.7
Relationship of the
Parties. The relationship between the Parties is and will be
that of independent contractors, and does and 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 actions, which are binding on the other Party, except with
the prior written consent of the other Party 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.
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 two (2) or more 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.
17.13 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 “Exhibit” are references to the
numbered sections of this Agreement and the exhibits attached to this Agreement,
unless expressly stated otherwise.
***
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
[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.
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
|
SANOFI-AVENTIS
|
|||
By:
|
/s/ Xxxx Xxxxxxxx
|
By:
|
/s/ Xxxxxx Contamine
|
|
Name:
|
Xxxx Xxxxxxxx
|
Name:
|
Xxxxxx CONTAMINE
|
|
Title:
|
SVP Business Development,
|
Title:
|
Executive Vice President and
|
|
Vorstand
|
Chief Financial Officer
|
|||
By:
|
/s/ Xxxxxxx Xxxxxxxx
|
By:
|
/s/ Xxxxxxxx Xxxxxxx
|
|
Name:
|
Xxxxxxx Xxxxxxxx
|
Name:
|
Xxxxxxxx Xxxxxxx
|
|
Title:
|
SVP & CSO, Vorstand
|
Title:
|
SVP, Chief Strategic Officer
|
Legal
Department Review: MaA
[Signature
Page to 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
Exhibit
A
Collaboration
Target
SwissProt
entry: [***]
Accession
number: [***]
[***]
***
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
Initial
Development Plan
***
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
Patents
within [***] Technology
[***]
[***]
Application
Number
|
Application
Filing Date
|
Country
|
Title of Application
|
Status
|
Patent Number
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
|||||
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
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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
[***]
Application
Number
|
Application
Filing Date
|
Country
|
Title of Application
|
Status
|
Patent Number
|
|||||
[***]
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[***]
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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
Exhibit
D
[***]
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
This
Exhibit D will automatically be amended to include any [***] entered into
between [***] and [***] pursuant to the [***]
***
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
***Text Omitted and Filed
Separately
Confidential
Treatment Requested
Under
17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
Exhibit
E
Patent
Jurisdictions
Patent Code
|
Patent Jurisdiction
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
|
[***]
|
***
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
Milestone
Schedule
Milestone Event
|
Milestone
Payments
|
||
[***]
of the [***] for a [***] or, if earlier,
the [***] of a [***] as
a [***]
|
€
[***]
|
||
[***]
of the [***] by the [***]
|
€
[***]
|
||
[***]
of [***] in [***]
(or [***] part of [***] )
|
[***]
|
€
[***]
|
|
[***]
|
€
[***]
|
||
[***]
of [***] in [***]
|
[***]
|
€
[***]
|
|
[***]
|
€
[***]
|
||
[***]
of [***] in a [***]
|
[***]
|
€
[***]
|
|
[***]
|
€
[***]
|
||
[***]
of a [***] in a [***]
|
[***]
|
€
[***]
|
|
[***]
|
€
[***]
|
||
[***]
for the [***] for the [***]
|
€
[***]
|
||
[***]
for the [***] for
the [***]
|
€
[***]
|
||
[***]
for the [***] for the [***]
|
€
[***]
|
Notwithstanding
anything to the contrary above, Sanofi will not be obligated to pay the
milestones described above for a particular Product as applicable to a [***] for
[***] for the [***] .
If a
milestone event described above is achieved that is subsequent to a preceding
milestone event with respect to which Sanofi has not yet made the corresponding
milestone payment, the preceding milestone event is deemed achieved, and the
corresponding milestone payment is due and payable together with the payment of
the milestone payment for the subsequent milestone event.
If the
development of a Product is terminated but the Parties subsequently develop
another Product against the same Collaboration Target, the milestone payments
made by Sanofi with respect to the terminated Product will not have to be made a
second time with respect to the Product replacing the terminated
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
Exhibit
G-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
Exhibit
G-2
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
***
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-1
Sanofi
Press Release
***
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-2
Micromet
Press Release
***
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
I
Dispute
Resolution Procedures
1.
|
The
Parties will resolve disputes stipulated in Section 17.4.3 (a) by final
and binding expertise proceedings in accordance with this Exhibit
I. The Parties will select a mutually agreeable expert
who has significant relevant experience in the subject matter of the
disputed issue and no affiliation or pre-existing relationship with either
Party. If the Parties cannot agree on an expert
within [***] days after
the [***] have failed to resolve the disagreement,
either Party may request the appointment of the expert in accordance with
the provisions for the appointment of experts under the Rules for
Expertise of the International Chamber of Commerce. The date on
which such expert is selected will be the “Proceeding Commencement
Date.”
|
2.
|
Each
Party will prepare and, within [***] ( [***] )
[***] after the Expertise Proceedings Commencement Date,
deliver to both the expert and the other Party its proposed license
agreement and a memorandum in support thereof (the “Support
Memorandum”). The expert will also be provided with a
copy of this Agreement.
|
3.
|
Within [***] (
[***] ) [***] after the receipt of all proposed
license agreements and Support Memoranda, the expert will select from the
two proposals provided by the Parties the proposal that the expert
believes [***] the [***] of the Parties to this
Agreement and the [***] the [***]
and [***] of [***] . The expert’s
decision will be provided in
writing.
|
4.
|
The
expert will have reasonable discretion to request additional information,
hold a hearing, and extend the time frame for reaching their decision
regarding the dispute at issue.
|
5.
|
The
expert’s fees and expenses will be shared equally by the
Parties. Each Party will bear and pay its own expenses incurred
in connection with any dispute resolution under this Exhibit
I.
|
***
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
J
[***]
[***]
***
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.