BiTE Research Collaboration Agreement
Exhibit 10.41
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
This BiTE Research Collaboration Agreement (“Agreement”) is made and entered into effective as
of June 6, 2003 (the “Effective Date”), by and between Micromet AG, having its principal place of
business at Xxxxxxxxxxxxxxxxx 0, 00000, Xxxxxx, Xxxxxxx (“Micromet”), and MedImmune, Inc., having
its principal place of business at 00 X. Xxxxxxx Xxxx Xxxx, Xxxxxxxxxxxx, XX 00000 (“MedImmune”).
Micromet and MedImmune each may be referred to herein individually as a “Party,” or collectively as
the “Parties.”
Recitals
A. Micromet is a biotechnology company that has developed the BiTE product platform, which is
useful for the development of antibody-based pharmaceutical products.
B. MedImmune is a biotechnology company with experience in the development and
commercialization of pharmaceutical products.
C. MedImmune desires to develop pharmaceutical products that target certain antigens using
Micromet’s BiTE product platform.
D. Micromet and MedImmune desire to collaborate on the development and commercialization of
BiTE products binding to antigens designated by MedImmune that are proprietary to MedImmune or in
the public domain.
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
When used in this Agreement, capitalized terms will have the meanings as defined below and
throughout this Agreement.
1.1 “Affiliate” means a legal entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with a Party. For purposes
of this definition only, “control” and, with correlative meanings, the terms “controlled by” and
“under common control with” means (a) the possession, directly or indirectly, of the power to
direct the management or policies of a legal entity, whether through the ownership of voting
securities or by contract relating to voting rights or corporate governance, or (b) the ownership,
directly or indirectly, of more than 50% of the voting securities or other ownership interest of a
legal entity; provided, however, that if local law restricts foreign ownership, control will be
established by direct or indirect ownership of the maximum ownership percentage that may, under
such local law, be owned by foreign interests.
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1.2 “Applicable Law” means the laws, rules, and regulations, including any statutes, rules,
regulations, or other requirements, that may be in effect from time to time and that apply to the
development, manufacture, registration, and marketing of Collaboration Product in the United States
and the European Union and its member states, including any such statutes, rules, regulations, or
other requirements of the FDA and the EMEA. If MedImmune is manufacturing Collaboration Product
for sale in Japan, the term “Applicable Law” will be deemed to include the laws, rules, and
regulations, including any rules, regulations, or other requirements of the Ministry of Health,
Labor and Welfare and any other Japanese regulatory authorities, that may be in effect from time to
time and apply to the development, manufacture, registration, and marketing of Collaboration
Product in Japan.
1.3 “Approved Collaboration Product” means a Collaboration Product selected by the JDC
pursuant to Section 4.1.1 for further development in a pre-clinical development program.
1.4 “BiTE Molecule” means a polypeptide comprising a bi-specific Single Chain Antibody binding
to T-cells.
1.5 “BiTE Product” means any composition or formulation containing a BiTE Molecule.
1.6 “BLA” means a Biologics License Application filed with the FDA in conformance with
applicable laws and regulations.
1.7 “cGMP” means current Good Manufacturing Practices as contained in 21 CFR Parts 210 and 211
as amended from time to time, and the equivalent Applicable Laws in jurisdictions outside the
United States.
1.8 “Clinical Trial Materials” means Collaboration Product formulated in accordance with
applicable specifications, and placebo of such formulations, for administration to patients in
clinical trials.
1.9 “Collaboration Product” means any composition or formulation containing a BiTE Molecule
binding to a Collaboration Target.
1.10 “Collaboration Target” means any Target selected by MedImmune pursuant to Section 2 that
becomes a Collaboration Target pursuant to Section 2.2.2.
1.11 “Collaboration Technology” means Joint Collaboration Technology, MedImmune Collaboration
Technology and Micromet Collaboration Technology.
1.12 “Commercial Process” means a commercial scale manufacturing process for a Collaboration
Product that is compliant with all Applicable Laws.
1.13 “Commercialization” means the marketing, promotion, advertising, selling or distribution
of a pharmaceutical product in a country after Marketing Approval has been obtained in such country
for such product. The term “Commercialize” has a correlative meaning.
1.14 “Commercially Reasonable Efforts” means those efforts consistent with the exercise of
prudent scientific and business judgment, as applied by a Party to the development of its own
research or development projects at a similar stage of development or Commercialization of
pharmaceutical products of similar market potential and market size, at a similar stage in the
product life cycle, taking into account the
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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.
1.15 “Control” and, with correlative meaning, the term “Controlled,” means, with respect to
any Patent, Know-How, or other intellectual property right of a Party, the ability to grant the
other Party access, a license or a sublicense (as applicable) or right to use such Patent,
Know-How, or intellectual property right as provided in this Agreement without violating the terms
of any agreement or other arrangement with any Third Party existing at the time such Party would be
required under this Agreement to grant the other Party such access, license, sublicense or right of
use.
1.16 “Co-Promotion Option” has the meaning set forth in Section 5.1.
1.17 “Development Activities” means any activities to be performed in connection with the
development of Collaboration Product pursuant to a Development Plan, including any in vitro or in
vivo studies, clinical studies in humans, and the preparation and filing of BLAs and XXXx.
1.18 “Development Cost” means the aggregate amount of costs incurred by MedImmune in research
and development of a Collaboration Product, including Commercial Process development and regulatory
filing costs as determined in a reasonable manner consistent with MedImmune’s normal internal cost
accounting practices and in accordance with generally accepted accounting principles, consisting
of: (i) [***], (ii) [***], (iii) [***], and [***], (iv) [***].
1.19 “Development Plan” has the meaning set forth in Section 3.2.4.
1.20 “EMEA” means the European Medicines Evaluation Agency and any successor agency thereof.
1.21 “Europe” means the countries located in Europe and including the Russian Federation and
Turkey.
1.22 “Excluded Target” has the meaning set forth in Section 2.2.1.
1.23 “FDA” means the United States Food and Drug Administration, and any successor agency
thereof.
1.24 “FTE” means the equivalent of a total of [***] per year of scientific or technical work
on or directly related to the execution or implementation of a Research Plan or a Development Plan
or other tasks to be performed under this Agreement, carried out by a qualified employee of a
Party, except to the extent included in [***]. Scientific or technical work includes performing
research, experimental laboratory work, developing manufacturing processes for Collaboration
Products, conducting pre-clinical and clinical development of Collaboration Products, recording and
writing up results, reviewing literature and references, holding scientific discussions, and
attending conferences in the relevant field.
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1.25 “FTE Rate” means US$[***] per FTE per annum for MedImmune, and €[***] per FTE per
annum for Micromet, which amount includes, for each FTE, [***]), [***], [***] and [***].
1.26 “Fully-Burdened Manufacturing Cost” means the consolidated fully burdened cost incurred
by MedImmune in the manufacture of Collaboration Product, consisting of: (i) [***]; (ii) [***];
(iii) [***], excluding any [***]; (iv) a charge for [***]; (v) [***] costs; (vi) a charge for
[***]; and (vii) charges for [***]; and (viii) [***] that are paid to a [***] with respect to
[***]; in each of the above cases to the extent reasonably allocable to the manufacture of
Collaboration Product as determined in accordance with United States generally accepted accounting
principles as applied by MedImmune consistently for all its products. To the extent that
manufacturing of Collaboration Product or any component thereof is performed for MedImmune by a
Third Party, amounts paid by MedImmune to such Third Party in connection with the manufacturing of
Collaboration Product or any component thereof, excluding any process development amortization
costs paid to such Third Party, will be added to the aggregate amount of the foregoing items (i)
through (viii).
1.27 “IND” means an Investigational New Drug Application filed with the FDA.
1.28 “Independent MedImmune Technology” means any Patent or Know-How, other than Collaboration
Technology, that (a) is Controlled by MedImmune or its Affiliates at any time during the Term, and
(b) claims or covers the composition, use, or manufacture of Collaboration Product, or compounds or
materials used or employed in the manufacture or use thereof or, in the case of Know-How, is useful
with respect to any of the foregoing.
1.29 “Independent Micromet Technology” means: (a) any Know-How (i) that, as of the Effective
Date, has been used or is being used by Micromet with respect to research, development, or
production of Collaboration Products, or (ii) that is Controlled by Micromet at any time during the
Term, in each case to the extent that such Know-How is useful with respect to the research,
development, or production of Collaboration Products; and (b) any Patent (i) that is owned by or
licensed to Micromet as of the Effective Date, (ii) that becomes owned by Micromet at any time
during the Term, except to the extent that such Patent is acquired from a Third Party under terms
that prevent Micromet from granting the licenses contemplated herein, or (iii) that is licensed to
Micromet by a Third Party under an agreement entered into after the Effective Date and as to which
Micromet has the right to grant the sublicenses contemplated herein, and in each of the foregoing
cases only to the extent that such Patent claims or covers a Collaboration Product or the
manufacture or use thereof or compounds or compositions used or employed in the manufacture or use
of a Collaboration Product. Independent Micromet Technology includes the Patents listed in
Exhibits A-1 and A-2.
1.30 “JDC” has the meaning set forth in Section 3.1.1.
1.31 “Joint Collaboration Technology” means any Patents and Know-How made or generated jointly
by employees, Third Party agents or independent contractors of both Parties or their Affiliates
during the course of, in furtherance of, and as a direct result of such employees, agents or
independent contractors performing an activity pursuant to this Agreement.
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1.32 “JPT” has the meaning set forth in Section 3.2.1.
1.33 “JPT Leader” has the meaning set forth in Section 3.2.1.
1.34 “Know-How” means (a) any scientific or technical information, results and data of any
type whatsoever, in any tangible or intangible form whatsoever, including databases, practices,
methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and quality control data, stability
data, studies and procedures, and manufacturing process and development information, results and
data, and (b) any biological, chemical, or physical materials.
1.35 “Licensed Technology” means the Independent Micromet Technology, the Micromet
Collaboration Technology, and Micromet’s rights and interest in Joint Collaboration Technology.
1.36 “MAA” means a marketing approval application filed with the EMEA, and any corresponding
applications in countries or territories other than the European Union and the United States.
1.37 “Major European Markets” means [***] and [***].
1.38 “Marketing Approval” means the approval of a BLA or MAA, and any pricing and
reimbursement approvals to the extent required by Applicable Law prior to the marketing and sale of
pharmaceutical products in a country.
1.39 “MedImmune Collaboration Technology” means any Patents and Know-How, other than MedImmune
Process Technology, made or generated solely by employees, or Third Party agents or independent
contractors of MedImmune or its Affiliates during the course of, in furtherance of, and as a direct
result of such employees, agents or independent contractors performing an activity pursuant to this
Agreement.
1.40 “MedImmune Process Technology” means any Patents and Know-How made or generated solely by
employees, Third Party agents or independent contractors of MedImmune or its Affiliates during the
course of, in furtherance of, and as a direct result of such employees, agents or independent
contractors performing an activity pursuant to this Agreement, in each case that is useful for the
manufacture of a Collaboration Product.
1.41 “Micromet Collaboration Technology” means any Patents and Know-How made or generated
solely by employees, Third Party agents or independent contractors of Micromet or its Affiliates
during the course of, in furtherance of, and as a direct result of such employees, agents or
independent contractors performing an activity pursuant to this Agreement.
1.42 “Net Profits” has the meaning as defined in Exhibit B.
1.43 “Net Sales” means the gross amount invoiced to Third Parties or received from Third
Parties without prior invoice by a Party, its Affiliates, or any of their sublicensees for the sale
of a Collaboration
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Product, less: (a) trade, quantity and cash discounts allowed; (b) commissions, discounts,
refunds, rebates (including federal, state or local government rebates), chargebacks, retroactive
price adjustments, all to the extent allowed; (c) refunds or credits for actual returns of a
Collaboration Product; (d) any tax imposed on the production, sale, delivery or use of a
Collaboration Product, including, without limitation, sales, use, excise or value added taxes,
other than income taxes; (e) freight and insurance costs included in the gross amount invoiced; (f)
a reasonable allowance for distribution expenses; and (g) actual write-offs of uncollectible
accounts receivable. Such amounts will be determined from the books and records of the applicable
Party, Affiliate, or sublicensee in accordance with United States generally accepted accounting
principles as applied by such entity consistently across its products. “Net Sales” excludes any
amounts invoiced or received in connection with any transfers of a Collaboration Product between a
Party and its Affiliates or their sublicensees who have the right to Commercialize a Collaboration
Product.
1.44 “Non-Proprietary Target” means a Target that is not a Proprietary Target.
1.45 “Patents” means (a) all patents and patent applications in any country or supranational
jurisdiction, and (b) any provisionals, substitutions, divisions, continuations, continuations in
part, reissues, renewals, registrations, confirmations, reexaminations, extensions, supplementary
protection certificates and the like, of any such patents or patent applications.
1.46 “Phase I Clinical Trial” means, as to a specific Collaboration Product, the first
controlled and lawful study in humans of the safety of such Collaboration Product, which is
prospectively designed to generate sufficient data (if successful) to commence a Phase II Clinical
Trial of such Collaboration Product, as further defined in Federal Regulation 21 C.F.R. 312.21, or
corresponding Applicable Laws outside the United States.
1.47 “Phase II Clinical Trial” means, as to a specific Collaboration Product, a controlled and
lawful study in humans of the safety, dose ranging and efficacy of such Collaboration Product,
which is prospectively designed to generate sufficient data (if successful) to commence a Pivotal
Trial of such Collaboration Product, as further defined in Federal Regulation 21 C.F.R. 312.21, or
corresponding Applicable Laws outside the United States.
1.48 “Pivotal Trial” means a clinical trial that is of size and design agreed to by the FDA
that is appropriate to establish that a pharmaceutical product is safe and effective for its
intended use, to define warnings, precautions and adverse reactions that are associated with the
pharmaceutical product in the dosage range to be prescribed, and to support Marketing Approval of
such pharmaceutical product or label expansion of such pharmaceutical product.
1.49 “Proprietary Target” means any Target (a) that is set forth on Exhibit C, or (b) as to
which, at the time of receipt of a Selection Notice for such Target, a BiTE Molecule binding to
such Target, or use of such a BiTE Molecule, is subject to issued Patents or patent applications
that: (i) are owned or exclusively licensed by MedImmune, (ii) in the case of patent applications,
have been submitted to the European Patent office or filed under the Patent Cooperation Treaty
designating Europe, (iii) in the case of issued Patents, have at least [***] of patent protection
remaining on one or more claims of such Patents, and (iv) would reasonably be expected to exclude
Micromet from developing and Commercializing a BiTE Product against such Target in Europe.
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1.50 “Qualified Sales Force” means, with respect to a Collaboration Product in a country, a
sales organization for such Collaboration Product capable of covering the target audience for such
Collaboration Product in such country to the lesser of: (a) [***]% of such target audience, and (b)
the percentage of the [***] that is [***] of such Collaboration Product in such country.
1.51 “Research Plan” has the meaning as defined in Section 3.2.3.
1.52 “Single Chain Antibody” means a single chain polypeptide having a binding affinity for
one or more Targets, and comprising: (a) a first polypeptide segment having a light chain variable
region, (b) a second polypeptide segment having a heavy chain variable region, and (c) at least one
peptide linker linking the first and second polypeptide segments into a single chain polypeptide.
1.53 “Target” means a cell-surface antigen.
1.54 “Technology Acquisition Agreement” means any agreement entered into before or after the
Effective Date between a Party and a Third Party under which such Party is granted a license to or
is assigned (a) any of such Third Party’s Patents that claim the composition, use, or manufacture
of Collaboration Product, or (b) any of such Third Party’s Know-How that covers or is useful with
respect to the composition, use, or manufacture of Collaboration Product. The Technology
Acquisition Agreements of Micromet that exist as of the Effective Date are listed in Exhibit D.
1.55 “Technology Acquisition Payments” means license fees, milestone payments, or royalties
payable by a Party to a Third Party under any Technology Acquisition Agreement in connection with
the development or Commercialization of a Collaboration Product.
1.56 “Territory” means all countries of the world, except that with respect to Collaboration
Products that bind to a Non-Proprietary Target, the Territory means all countries of the world
except the countries in Europe.
1.57 “Third Party” means any entity other than Micromet, MedImmune or their respective
Affiliates.
1.58 “Upstream Licensor” means Micromet’s licensor of the [***] Patent.
1.59 “Valid Claim” means an issued claim of an issued patent that has not (a) expired or been
canceled, (b) been declared invalid by a decision of a court or other appropriate body of competent
jurisdiction that has not been appealed or that is not appealable, (c) been admitted to be invalid
or unenforceable through reissue, disclaimer or otherwise, or (d) been abandoned or disclaimed.
1.60 “[***] Patent” means the patent listed in Exhibit E.
2. Selection of Collaboration Targets
2.1 Identification of Targets by MedImmune.
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2.1.1 Selection Notice. During the period beginning on the Effective Date and ending [***]
after Micromet initiates work under Section 4.1.1 with respect to the first Collaboration Target
(the “Selection Period”), MedImmune has the right to provide Micromet written notice of specific
Targets with respect to which MedImmune wishes to commence the development of a BiTE Molecule.
Each such notice (a “Selection Notice”) will set forth a detailed description of the Target,
including any Patents of MedImmune or Patents of Third Parties known to MedImmune that may claim
such Target or the use thereof or antibodies against such Target, as well as a description of
whether such Target, in MedImmune’s estimation, is a Proprietary Target or a Non-Proprietary
Target. The Selection Period may be extended by successive [***] periods upon mutual agreement of
the Parties no later than 30 days prior to the expiration of the original Selection Period or any
extension thereof. MedImmune agrees to provide a Selection Notice within [***] from the Effective
Date and, if MedImmune fails to do so, as the sole and exclusive remedy for such failure, Micromet
may terminate this Agreement.
2.1.2 Target Limitation. MedImmune may provide a Selection Notice for Proprietary Targets
until [***] such Proprietary Targets have become Collaboration Targets as provided for in Section
2.2. Except with the prior written consent of Micromet, MedImmune’s right under Section 2.1.1 to
provide Selection Notices for Targets will expire at the time when a total of [***] Targets have
become Collaboration Targets pursuant to Section 2.2. In the event that there is a change in
Target status under Section 2.2.3, MedImmune will have the right to select such Target even if
MedImmune has selected the maximum number of Targets under this Section 2.1.2.
2.2 Gatekeeping Process.
2.2.1 Exclusion Criteria. Upon receipt of a Selection Notice, Micromet will within [***] days
determine whether the Target described in such Selection Notice is the same as: (a) any Target set
forth on Exhibit F; (b) any Target that, at such time, is part of a development program conducted
at Micromet that has been approved by Micromet’s Project Monitoring Committee; (c) any Target for
which at such time Micromet has granted a Third Party the exclusive right to develop or
Commercialize a BiTE Product that binds to such Target; or (d) any Target for which Micromet at
such time is in good faith discussions with a Third Party respecting an agreement to grant such
Third Party an exclusive right to develop, co-develop with Micromet, or Commercialize a BiTE
Product that binds to such Target (each such Target described in (a), (b), (c), and (d) above an
“Excluded Target”).
2.2.2 Notification by Micromet. If a Target described in a Selection Notice is an Excluded
Target, then Micromet will notify MedImmune in writing of the grounds for the exclusion during the
[***] period described above. If a Target described in a Selection Notice is not an Excluded
Target, then Micromet will notify MedImmune in writing thereof during the [***] period described
above, and such Target will become a Collaboration Target upon dispatch of such notice to MedImmune
or upon the failure of Micromet to provide any notice during such [***] period. For each Target
that becomes a Collaboration Target under this Section 2.2.2, Micromet will provide notice to
MedImmune of Micromet’s determination as to whether such Collaboration Target is a Proprietary
Target. Each such notice will include reasonable documentation supporting Micromet’s
determination. If the Parties fail to agree as to whether a Collaboration Target is a Proprietary
Target (including, without limitation, due to a disagreement as to whether one or more claims in a
patent application would reasonably be expected to be granted),
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MedImmune will have the right to submit such issue to arbitration under Section 22.4. If a
Target described in a Selection Notice as a Proprietary Target is, as the result of arbitration,
judged not to be a Proprietary Target, then MedImmune may withdraw such Target from selection and
such Target will be treated for the purposes of the limits set forth in Section 2.1.2 as if
MedImmune had not submitted a Selection Notice for such Target.
2.2.3 Change of Target Status.
(a) If a Target designated an Excluded Target pursuant to Section 2.2.1 becomes available for
selection as a Collaboration Target in that the circumstance of Section 2.2.1 that caused the
Target to become an Excluded Target no longer exists, then as of such date, such Target will no
longer be deemed an Excluded Target under Section 2.2.1, Micromet will promptly notify MedImmune of
such availability, and MedImmune may thereafter tender a Selection Notice with respect to such
Target as provided in Section 2.1.1.
(b) If with respect to a Target designated an Excluded Target pursuant to Section 2.2.1(d)
Micromet does not execute an agreement under which a Third Party is granted an exclusive right to
develop, co-develop with Micromet, or Commercialize a BiTE Product that binds to such Excluded
Target within [***]s following such designation, then, as of the expiration of such [***] period,
such Target will no longer be deemed an Excluded Target under Section 2.2.1(d), Micromet will
promptly notify MedImmune thereof, and MedImmune may thereafter tender a Selection Notice with
respect to such Target as provided in Section 2.1.1.
3. Collaboration Governance for Collaboration Products
3.1 Joint Development Committee.
3.1.1 Establishment of the JDC. Promptly after the first Target becomes a Collaboration
Target pursuant to Section 2, the Parties will establish a joint development committee (the “JDC”),
which will oversee the research and development of Collaboration Products under this Agreement.
Each Party will appoint two employees to serve as its representatives on the JDC. From time to
time, Micromet and MedImmune each may substitute any of its representatives on the JDC. The JDC
will meet in person not less than once every calendar semester. Each Party will bear its own costs
associated with holding and attending such meetings. Subject to the provisions of this Section 3,
the JDC will establish its own procedural rules for its operation.
3.1.2 Tasks of the JDC. The JDC will: (a) select Approved Collaboration Products for
preclinical development from BiTE Molecules constructed by Micromet pursuant to Section 4.1.1; (b)
review and approve the Research Plan for each Approved Collaboration Product and any updates or
amendments thereto proposed by the JPT; (c) prior to the filing of the first IND for any Approved
Collaboration Product, determine the indications to be pursued in the clinical development of such
products; (d) review and approve the Development Plan for each Approved Collaboration Product and
any updates or amendments thereto proposed by the JPT; (e) review the product lifecycle plans for
Approved Collaboration Products, including indication and label expansions, new dosage forms, and
new formulations or delivery systems; and (f) take such other actions as are expressly delegated to
the JDC in this Agreement.
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3.1.3 JDC Meetings. Each Party will designate one of its representatives on the JDC as a
co-chairperson. The co-chairpersons will be responsible for organizing the meetings of the JDC and
for setting the agenda of the meetings. An agenda will be agreed upon by the co-chairpersons and
be distributed to the Parties no less than one week before any JDC meeting. Upon prior written
notice to the other Party, a 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 15) to attend any meeting of the JDC. Each meeting
of the JDC will include at least one representative from each Party.
3.1.4 Meeting Minutes. Minutes will be kept of all JDC meetings by the hosting Party and sent
to all members of the JDC for review and approval within 7 days after each meeting. Minutes will
be deemed approved unless any member of the JDC objects to the accuracy of such minutes by
providing written notice to the other members of the JDC within 14 days of receipt of the minutes.
In the event of any such objection that is not resolved by mutual agreement of both
co-chairpersons, such minutes will be amended to reflect such unresolved dispute.
3.1.5 Decision Making.
(a) The JDC will take action by unanimous consent of its members, with each representative
having a single vote, or by a written resolution signed by all of the representatives.
(b) If the JDC is unable to reach unanimous consent on a particular matter, then the matter
will be referred to the Chief Executive Officers the Parties who will use good faith efforts to
resolve such matter. If such officers fail to resolve such matter, then the [***] of [***] will
finally decide the issue, except that if such matter is primarily related to Micromet’s activities
to be performed for the development in Europe of an Approved Collaboration Product that binds to a
Non-Proprietary Target, the [***] of [***] will finally decide the issue.
(c) Notwithstanding the provisions in this Section 3.1.5 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 decided in accordance with the terms of Section 22.4.
(d) The JDC will not have any power to amend this Agreement and will have only such powers as
are specifically delegated to it under this Agreement. Without limiting the preceding sentence,
the Parties understand and agree that the JDC has no decision-making authority with respect to
Commercialization of any Approved Collaboration Product.
3.2 Joint Project Team.
3.2.1 Establishment of the JPT. Promptly after the Effective Date, the JDC will establish a
joint project team consisting of an adequate number of employees of both Parties that will be
responsible for managing the execution of each Development Plan (the “JPT”). Each Party will
designate one of its JPT members as the co-leader of the JPT (each, a “JPT Leader”). The JPT
Leaders may, in their
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discretion, create sub-teams of the JPT for the purpose of carrying out specific tasks
provided for in a Development Plan.
3.2.2 Decision Making. The JPT will act by unanimous consent of its members or by a written
resolution signed by both JPT Leaders. If the JPT is unable to reach unanimous consent on a
particular matter, either JPT Leader may refer such matter to the JDC for resolution.
3.2.3 Research Plan. Promptly after a Target becomes a Collaboration Target pursuant to
Section 2.2.2, the JPT will prepare a plan for the construction of BiTE Molecules binding to the
Collaboration Target, and the pre-clinical development of Approved Collaboration Products binding
to such target up to and including the filing of an IND for such products (each such plan a
“Research Plan”). Each such Research Plan will provide for Micromet to construct the BiTE
Molecules and, if applicable, to perform any re-engineering thereof, and will include a detailed
set of features or specifications for such BiTE Molecules. Each Research Plan will include a
budget of the costs and expenses to be incurred by the Parties and their subcontractors in the
performance of the tasks and activities described in such Research Plan, as well as a description
of the preclinical proof of concept criteria described in clause (1) of the table set forth in
Section 13.1. Any changes to the Research Plan, including changes to the target dates included in
the Research Plan or the budget, will be discussed in the JPT. The JPT will update the Research
Plan for approval by the JDC from time to time, but in any case at least semi-annually.
3.2.4 Development Plan. Promptly after the decision of the JDC to file an IND for a
particular Approved Collaboration Product, the JPT will develop the clinical development strategy
and prepare a plan for the clinical development through the filing of Marketing Approvals for such
Approved Collaboration Product in the Major European Markets, the United States and Japan (each
such plan a “Development Plan”). Each Development Plan will include a budget of the costs and
expenses to be incurred by the Parties and their subcontractors in the performance of the tasks and
activities described in such Development Plan. Any changes to a Development Plan, including
changes to the target dates included in the Development Plan or the budget, will be discussed in
the JPT. The JPT will update each Development Plan for approval by the JDC from time to time, but
in any case at least semi-annually.
3.2.5 Reporting. Within [***] after the end of each calendar quarter and at least one week
prior to any JDC meeting, the JPT Leaders will provide to the JDC a written progress report, which
will describe the progress made in the execution of the Research Plans and Development Plans since
the last such report. In addition to the progress reports provided hereunder, it is contemplated
that the Parties and the JPT Leaders will maintain informal communications through the JDC on their
day-to-day activities under this Agreement.
3.2.6 Agendas; Meetings; Minutes. The JPT Leaders will be responsible for organizing the
meetings of the JPT and for setting the agenda of the meetings. An agenda will be agreed upon by
the JPT Leaders and distributed to the Parties no less than one week before any JPT meeting.
Minutes will be kept of all JPT meetings by the hosting Party and sent to all members of the JPT
for review and approval within 7 days after each meeting. 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 14 days
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of receipt of the minutes. In the event of any such objection that is not resolved by mutual
agreement of both JPT Leaders, such minutes will be amended to reflect such unresolved dispute.
4. Research and Development of Collaboration Products
4.1 Preclinical Research and Development.
4.1.1 No later than [***] after the approval of each Research Plan by the JDC, Micromet will
commence with the construction of BiTE Molecules, and will be responsible for creating BiTE
Molecules that meet the specifications contained in such Research Plan. Micromet will present the
JDC with any BiTE Molecules meeting the applicable criteria, and the JDC may select one or more of
such BiTE Molecules as an Approved Collaboration Product for further development in a pre-clinical
development program as further described in the applicable Research Plan. Micromet will not be
obligated to initiate work under more than one Research Plan during any [***] period.
4.1.2 Each Party will use Commercially Reasonable Efforts to perform the tasks assigned to it
in each Research Plan with respect to the preparation of an IND filing for the applicable Approved
Collaboration Product.
4.2 Clinical Development of Collaboration Products binding to Proprietary Targets. With
respect to the development of any Approved Collaboration Product binding to a Proprietary Target,
and as set forth in greater detail in each applicable Development Plan, as between Micromet and
MedImmune, MedImmune will have the sole right to (a) perform any Development Activities necessary
to enable the filing of a BLA and XXXx in the indications set forth in the applicable Development
Plan in the Territory, and (b) file and prosecute such BLA and XXXx through the grant of Marketing
Approval for such Approved Collaboration Product in the Territory. Without limiting the foregoing,
Micromet will not conduct any clinical trial for an Approved Collaboration Product binding to a
Proprietary Target without MedImmune’s express, prior, written consent.
4.3 Clinical Development of Collaboration Products binding to Non-Proprietary Targets.
4.3.1 With respect to the development of any Approved Collaboration Product binding to a
Non-Proprietary Target, and as set forth in greater detail in each applicable Development Plan, as
between Micromet and MedImmune, MedImmune will have the sole right to: (i) perform any Development
Activities necessary to enable the filing of a BLA and the XXXx in the indications set forth in the
applicable Development Plan in countries outside of Europe; (ii) file and prosecute such BLA and
XXXx through the grant of Marketing Approval for such Approved Collaboration Product in countries
outside of Europe; and (iii) perform any Development Activities provided for in the Development
Plan for the development of the applicable Approved Collaboration Product in Europe up to and
including the completion of Phase I Clinical Trials, if any. MedImmune will not conduct any
clinical trial in Europe for an Approved Collaboration Product binding to Non-Proprietary Targets
after the completion of Phase I Clinical Trials for such Approved Collaboration Product without
Micromet’s express, prior, written consent. Micromet will not conduct any clinical trial in the
Territory for Approved Collaboration Products binding to Non-Proprietary Targets without
MedImmune’s express prior written consent.
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4.3.2 With respect to the development of any Approved Collaboration Product binding to a
Non-Proprietary Target, Micromet or its designees will perform any Development Activities in
addition to those performed by MedImmune pursuant to Section 4.3.1 above as may be necessary to
obtain Marketing Approval for such Approved Collaboration Product in Europe. Micromet will not
conduct any clinical trial for such Approved Collaboration Products in countries outside of Europe
without MedImmune’s express, prior, written consent.
4.3.3 The Parties will continuously inform each other of their Development Activities with
respect to any Approved Collaboration Product binding to a Non-Proprietary Target that is developed
by Micromet pursuant to Section 4.3.2 above, through their interactions in the JPT and through
progress reports submitted to the JDC. Upon the reasonable request of a Party, the other Party
will provide the requesting Party with copies of clinical trial protocols, preliminary reports and
final reports of any clinical studies performed by such other Party, and any other information or
data Controlled by such other Party relating to such product.
4.3.4 Each Party hereby grants to the other Party (the “Passive Party”) the right to use and
reference: (a) any non-clinical data, clinical data (including raw data, safety data, and efficacy
data), and clinical trial protocols relating to any Approved Collaboration Product binding to a
Non-Proprietary Target, (b) any INDs, BLAs, MAAs, other regulatory filings, and Marketing Approvals
for any such Approved Collaboration Product, and (c) any correspondence with any regulatory
authorities relating to any such Approved Collaboration Product; in each case, as generated,
developed or received by or on behalf of the granting Party in the course of the performance of
this Agreement, and in each case, for the development of Approved Collaboration Products and the
filing and prosecution of any INDs, BLAs, and XXXx, and the maintenance of any Marketing Approvals
and other regulatory approvals of Approved Collaboration Products by the Passive Party in countries
outside of Europe (if MedImmune is the Passive Party) or in countries inside of Europe (if Micromet
is the Passive Party). In addition, if a Party receives notice of a scheduled meeting or visit
with a regulatory authority relating to such Party’s development, manufacture, or Commercialization
of an Approved Collaboration Product binding to a Non-Proprietary Target, then such Party will
notify the Passive Party of such meeting or visit and such Passive Party will have the right to
have [***] representatives of such Passive Party present at such meeting or visit, provided that
each such representative remains a silent observer throughout such meeting or visit. Each Party
will take all necessary and proper acts, and will cause its employees, Affiliates, agents, and
independent contractors to take such necessary and proper acts, to effectuate the rights of use and
reference provided in this Section 4.3.4.
4.4 Research and Development Costs.
4.4.1 Research Plan.
(a) MedImmune will bear the costs and expenses incurred by MedImmune in the performance of
activities under the Research Plan. MedImmune will pay any costs and expenses incurred by Micromet
in the performance of any activities provided for in the Research Plan quarterly in advance within
[***] after receipt of a corresponding invoice from Micromet that estimates the costs and expenses
for such quarter. Micromet employees will be charged on an hourly basis at the FTE Rate. Goods
and services provided by Third Parties specified and agreed upon in the Research Plan that are paid
by
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13
Micromet will be charged at [***]. In no event will MedImmune be obligated to make any
payments to Micromet for research activities that are not included in the applicable Research Plan
or that are in excess of [***]% of the amount included in the budget of such Research Plan for a
calendar year, unless such expenses have been approved in writing by the JDC in advance. In no
event will Micromet be obligated to incur costs and expenses for research activities that are not
included in the applicable Research Plan or costs and expenses in excess of the amount included in
the budget of such Research Plan, unless such costs and expenses have been approved in writing by
the JDC in advance.
(b) Micromet will provide quarterly reports on its activities under each Research Plan and the
costs and expenses for such activities. If such report reveals that Micromet’s actual, documented
costs and expenses were lower than the amount paid by MedImmune in advance for such quarter, the
overpayment will be credited to the next payment due under this Section 4.4. If such report
reveals that Micromet’s actual, documented costs and expenses were higher than the amount paid by
MedImmune in advance for such quarter, MedImmune will make a supplemental payment for the unpaid
amount within [***] after receipt of such report.
(c) MedImmune will have the right to terminate research with respect to Collaboration Products
against a Collaboration Target and the activities under a Research Plan with respect thereto by
[***] prior written notice to Micromet, and after the expiration of such [***] period, MedImmune
will no longer be obligated for costs and expenses incurred by Micromet with respect to
Collaboration Products against such Collaboration Target. During such 3-month period, MedImmune
will be responsible for the costs and expenses that are reasonably incurred in terminating the
activities under the Research Plan, including without limitation any ongoing personnel costs for
Micromet employees engaged in such activities, to the extent such employees cannot be reassigned to
other projects.
4.4.2 Development Plan. Unless expressly agreed otherwise, each Party will bear any costs and
expenses incurred by such Party in the performance of Development Activities provided for in a
particular Development Plan.
4.5 Diligence.
4.5.1 MedImmune will use Commercially Reasonable Efforts (a) to develop and to obtain
Marketing Approval in [***], the [***] and [***] for an Approved Collaboration Product binding to
each Proprietary Target, (b) to develop and to obtain Marketing Approval in [***] and [***] for an
Approved Collaboration Product binding to each Non-Proprietary Target, and (c) to develop a
Commercial Process for each Approved Collaboration Product developed by MedImmune under this
Agreement. It is expressly understood that MedImmune will not be required to perform trials for or
seek Marketing Approval for an Approved Collaboration Product in [***] [***] (with respect to
Approved Collaboration Products binding to Proprietary Targets) until MedImmune has obtained
Marketing Approval for such Approved Collaboration Product in [***]. It is further expressly
understood that MedImmune will not be required to perform trials for or seek Marketing Approval for
an Approved Collaboration Product in [***] until MedImmune has obtained Marketing Approval for such
Approved Collaboration Product in [***] and [***] (with respect to Approved Collaboration Products
binding to Proprietary Targets). All efforts of MedImmune’s Affiliates and sublicensees, together
with any efforts of Micromet performed under a
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Development Plan (to the extent applicable to MedImmune’s development efforts for the
applicable country), will be considered efforts of MedImmune for the purpose of determining
MedImmune’s compliance with its obligations under this Section 4.5.1.
4.5.2 If Micromet determines that MedImmune has failed to meet its obligations under Section
4.5.1 with respect to an Approved Collaboration Product, then, as the sole and exclusive remedy for
such failure, Micromet will have the right to terminate the licenses granted to MedImmune under
this Agreement with respect to such Approved Collaboration Product pursuant to Section 17.2.
4.5.3 Micromet will use Commercially Reasonable Efforts to construct BiTE Molecules meeting
the specifications in the Research Plans and otherwise to perform the activities assigned to
Micromet in each Research Plan and Development Plan.
4.6 Exchange of CMC Documentation. Upon completion of development of each Commercial Process
for an Approved Collaboration Product binding to a Non-Proprietary Target, MedImmune will provide
to Micromet, or at the discretion of MedImmune to the applicable regulatory agency, all necessary
CMC documentation for Europe in the possession of MedImmune, its Affiliates, contractors, or
licensees and, as reasonably requested by Micromet, assistance with the presentation of such
documentation to regulatory authorities in Europe, all as required for filing in Europe of an MAA
relating to the manufacture of the applicable Collaboration Product by means of such Commercial
Process and Micromet will reimburse MedImmune at the FTE Rate for such assistance.
4.7 Restrictions on Development and Commercialization of Licensed Products
4.7.1 During the period commencing on the Effective Date and ending on the earlier of (a) the
date 4 years after the Effective Date, and (b) any termination of this Agreement, MedImmune hereby
covenants not to engage, directly or indirectly, in the research, development, or Commercialization
of any BiTE Product that is not an Approved Collaboration Product under this Agreement or a
“Licensed Product” under that certain Collaboration and License Agreement executed by the Parties
on the Effective Date.
4.7.2 During the Term, Micromet will not itself or through any Third Party (whether through
the grant of a license or otherwise) develop or Commercialize outside of Europe any Collaboration
Product binding to Non-Proprietary Targets, except as expressly permitted under the terms of this
Agreement. During the Term, MedImmune will not itself or through a Third Party, whether through
the grant of a license or otherwise, develop or Commercialize in Europe any Collaboration Product
binding to Non-Proprietary Targets.
4.7.3 During the period that MedImmune has licenses under this Agreement to a Collaboration
Product, neither Party shall develop or perform clinical trials or obtain marketing approval for
such Collaboration Product, other than for an Approved Collaboration Product as permitted by this
Agreement.
5. Co-Promotion Option
5.1 Grant and Exercise. MedImmune hereby grants Micromet an option with respect to any
Approved Collaboration Product binding to a Proprietary Target to obtain the right to co-promote
such Approved Collaboration Product in Europe (the “Co-Promotion Option”). Micromet may exercise
such option with respect to each such Approved Collaboration Product by written notice to MedImmune
at any
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time prior to the [***] with such Approved Collaboration Product. Such exercise will be
effective on the date of receipt of such written notice by MedImmune (the “Exercise Date”). Upon
such exercise, Micromet will have the right to participate in the Commercialization of such
Approved Collaboration Product in Europe by sharing [***]% of the Net Profits generated by
MedImmune with such Approved Collaboration Product, as provided in Section 13.3.
5.2 Development Following Option Exercise. The development of an Approved Collaboration
Product with respect to which Micromet has exercised the Co-Promotion Option will continue pursuant
to the terms of Sections 2, 3 and 4. MedImmune will file and prosecute an MAA, and maintain any
Marketing Approval granted on such MAA, in all Major European Markets and any other countries in
Europe reasonably designated by Micromet prior to the filing of the first MAA in Europe.
5.3 Development Costs. If Micromet has exercised the Co-Promotion Option with respect to an
Approved Collaboration Product, then Micromet will bear [***]% of MedImmune’s Development Cost
incurred in connection with the worldwide development of such Approved Collaboration Product [***]
for such Approved Collaboration Product in accordance with the applicable Development Plan.
Micromet will pay Micromet’s share of such Development Costs for Development Activities provided
for in the Development Plan quarterly in arrears within 30 days after receipt of a corresponding
invoice from MedImmune. With each invoice, MedImmune will provide a detailed accounting of the
costs and expenses invoiced.
5.4 Co-Promotion Agreement.
5.4.1 Within [***] after completion of the Pivotal Trials required for obtaining Marketing
Approval in the Major European Markets for an Approved Collaboration Product for which Micromet has
exercised the Co-Promotion Option, the Parties will negotiate in good faith a co-promotion
agreement governing the co-promotion of such Approved Collaboration Product by the Parties in
Europe. The co-promotion agreement will provide for a role of the Parties in the marketing and
promotion of the applicable Approved Collaboration Product in Europe commensurate with the Parties’
respective sales force capabilities; provided, however, that MedImmune will set the sales price,
book all sales revenue, and have control over the marketing and sales programs in Europe.
5.4.2 Dispute Resolution for Co-Promotion Terms.
(a) If the Parties are unable to agree on all terms of the co-promotion agreement with respect
to a particular Collaboration Product prior to the expiration of the [***] period referred to in
Section 5.4.1, the Parties may select a mutually agreeable arbitrator who has significant relevant
experience in the pharmaceutical industry and the promotion of pharmaceutical products in Europe
and no affiliation or pre-existing relationship with either Micromet or MedImmune. If the Parties
cannot agree on an arbitrator within [***] after the termination of the [***] period described in
Section 5.4.1, either Party may request the Judicial Arbitration Mediation Services (“JAMS”) in
Washington, D.C. to appoint an arbitrator with such experience on behalf of the Parties in
accordance with the commercial arbitration rules of JAMS. The date on which such arbitrator is
selected will be the “Arbitration Commencement Date.”
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(b) Within [***] after the Arbitration Commencement Date, each Party will prepare and deliver
to both the arbitrator and the other Party its proposed co-promotion agreement and a memorandum
(the “Support Memorandum”) in support thereof. The arbitrator will also be provided with a copy of
this Agreement. Within [***] after receipt of the other Party’s Support Memorandum, each Party may
submit to the arbitrator (with a copy to the other Party) a rebuttal to the other Party’s Support
Memorandum (a “Rebuttal”), which may include a revision, marked to show changes, of either Party’s
proposed co-promotion agreement. Neither Party may have communications (either written or oral)
with the arbitrator other than for the sole purpose of engaging the arbitrator or as expressly
permitted in this Section 5.4.2.
(c) Within [***] after the Arbitration Commencement Date, the arbitrator will select from the
two co-promotion agreements provided by the Parties the co-promotion agreement that he or she
believes most accurately reflects the intention of the Parties to this Agreement and the industry
customs regarding the co-promotion of pharmaceutical biopharmaceutical products (the “Selected
Agreement”). The Selected Agreement will become a binding and enforceable agreement between
Micromet and MedImmune.
(d) The arbitrator will have reasonable discretion to request additional information, hold a
hearing, and extend the time frame for reaching his or her decision regarding the dispute at issue.
To the extent any further arbitration rules or procedures are necessary for resolution of the
dispute at issue, the arbitration rules of JAMS will apply. Notwithstanding the foregoing, the
Parties are not required to select an arbitrator from JAMS’s panel of arbitrators. The
arbitrator’s fees and expenses will be paid by the Party whose form of co-promotion agreement is
not selected by the arbitrator. Each Party will bear and pay its own expenses incurred in
connection with any contract resolution under this Section 5.4.2.
5.4.3 Buy-Out of Co-Promotion Option. At any time prior to or after the exercise of the
Co-Promotion Option by Micromet, but in any event before the Parties refer a co-promotion agreement
to arbitration pursuant to Section 5.4.2, MedImmune will have the right to terminate such option or
the co-promotion right by providing written notice of such termination to Micromet. Upon such
termination, MedImmune will pay Micromet a royalty of [***]% of all Net Sales of such Approved
Collaboration Product in [***] sold by MedImmune, its Affiliates or
their sublicensees for the royalty term of Section 13.2.2(a), and will assume any Technology Acquisition Payments that may
become due as a result of the development or Commercialization of such Approved Collaboration
Product in Europe. In such event, Section 13.2.3 will apply with respect to such payments;
provided, however, that in no event will the credit set forth in Section 13.2.3(b) reduce the
amount of royalties due and payable by MedImmune to Micromet under this Section 5.4.3 to less than
[***]% of Net Sales of such Approved Collaboration Product in Europe. For the avoidance of doubt,
the royalties set forth in this Section 5.4.3 are in lieu of, and not in addition to, the royalties
set forth in Section 13.2.1.
5.4.4 Loss of Co-Promotion Rights. If, at the time of an MAA filing in Europe for an Approved
Collaboration Product as to which Micromet has exercised Micromet’s co-promotion rights in
accordance with this Agreement, Micromet does not have a Qualified Sales Force for co-promoting
such Collaboration Product in one or more countries in Europe, MedImmune will have the right to
terminate
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Micromet’s co-promotion rights for such Collaboration Product in each such country by written
notice to Micromet. Upon such written notice, Micromet’s co-promotion rights will be terminated
with respect to such Collaboration Product in each such country and thereafter MedImmune will be
obligated to pay royalties to Micromet with respect to Net Sales of such Collaboration Product in
each such country in accordance with Section 13.2.1(c), as well as Sections 13.2.1(a) and (b). In
the event that there is a dispute between the Parties as to whether or not Micromet has such a
Qualified Sales Force in one or more countries, such issue will be submitted to arbitration under
Section 22.4 and Micromet’s co-promotion rights will continue in each such country until there is a
decision in such arbitration that Micromet does not have a Qualified Sales Force in such country at
the time of the MAA filing.
6. Reversion of Collaboration Products; Expiration of Collaboration
6.1 Reversion of Products.
6.1.1 Reversion Triggers and Territories. If MedImmune notifies Micromet of its decision to
discontinue the development or Commercialization of all Collaboration Products binding to a
particular Non-Proprietary Target, Micromet will have the exclusive right to continue the
development of and to Commercialize any and all Collaboration Products binding to such
Non-Proprietary Target on a worldwide basis. If MedImmune notifies Micromet of its decision to
discontinue development or Commercialization of all Collaboration Products binding to a particular
Proprietary Target in Europe and Micromet has exercised a Co-Promotion Option and made the
contribution to development costs set forth in Section 5.3 with respect to each Approved
Collaboration Product, then Micromet will have the exclusive right to continue the development of
and to Commercialize any and all Collaboration Products against such Proprietary Target being
developed by MedImmune at such time, but only for sale and use in Europe. In each of the above
cases, such rights will become effective only upon provision by Micromet of the notice described in
Section 6.1.2.
6.1.2 Continuation Notice. If Micromet decides to continue the development or
Commercialization of Collaboration Products under Section 6.1.1 or Section 18.1.1, it will provide
MedImmune with written notice of such decision (the “Continuation Notice”) within [***] after
receipt of the notice from MedImmune under Section 6.1.1, or within [***] after the effective date
of termination in the entirety of MedImmune’s licenses under this Agreement, as applicable. During
such [***] period, MedImmune will make available to Micromet all data and information relating to
such product generated by or on behalf of MedImmune in the performance of the applicable Research
Plan and Development Plan, other than MedImmune Process Technology, as may be reasonably requested
by Micromet to determine its interest in such Collaboration Products.
6.1.3 Licenses and Royalties. If Micromet decides to continue the development or
Commercialization of a Collaboration Product pursuant to this Section 6.1, Micromet will bear all
costs and expenses incurred by it in the development and Commercialization of such Collaboration
Product, including any Technology Acquisition Payments becoming due and payable after Micromet has
provided the Continuation Notice. In addition, Micromet will pay to MedImmune a [***] of such
Collaboration Product that is equal to [***], subject to the [***] set forth in Section [***].
Payment of said royalty to MedImmune will expire if and when the [***] has reached the [***] in
connection with the development of
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such Collaboration Product pursuant to the applicable Research Plan and Development Plan to
the extent such [***] were not [***] under this Agreement, plus an interest charge of [***]%
compounded annually on [***]. For the avoidance of doubt, notwithstanding the termination of
royalty payments, Micromet will continue to pay all Technology Acquisition Payments under
Technology Acquisition Agreements of MedImmune and Micromet that become due as a result of
Micromet’s development and Commercialization of such Collaboration Products.
6.1.4 Any continuation of development or Commercialization of a Collaboration Product pursuant
to this Section 6.1 will be subject to the terms and conditions set forth in Section 18.1.
6.2 Expiration of Collaboration.
6.2.1 The decision-making powers of the JDC and the JPT will cease to apply to the development
of any Approved Collaboration Product for which Micromet fails to exercise the Co-Promotion Option
or for which Micromet’s Co-Promotion Option or co-promotion rights have been terminated. MedImmune
will assume full control over the development of such Approved Collaboration Products, except that
MedImmune will update Micromet at the meetings of the JDC regarding the progress of the
development, and will provide Micromet with the Development Plan and any updates thereof prepared
by MedImmune in accordance with its normal business practices.
6.2.2 The decision-making powers of the JDC and the JPT will cease to apply to the development
of Collaboration Products that are developed by Micromet after MedImmune has discontinued its
development thereof. Micromet will assume full control over the development of such Collaboration
Products as to which Micromet has provided MedImmune with a Continuation Notice, except that
Micromet will update MedImmune at the meetings of the JDC regarding the progress of the
development, and will provide MedImmune with the Development Plan and any updates thereof prepared
by Micromet in accordance with its normal business practices.
7. Supply of Collaboration Product
7.1 Clinical Supply of Collaboration Products. Upon establishing a manufacturing process
suitable for producing Clinical Trial Materials, MedImmune itself or through a Third Party will
manufacture and supply Clinical Trial Materials in accordance with Applicable Law and cGMP for all
clinical trials for such Collaboration Products conducted by the Parties pursuant to a Development
Plan. For clinical trials of Collaboration Product conducted by Micromet pursuant to this
Agreement, MedImmune will supply Micromet with such Clinical Trial Materials on the terms and
conditions set forth in this Section 7.
7.2 Supply Price, Forecasting and Purchase Orders. Upon establishing a manufacturing process
suitable for producing Clinical Trial Materials, MedImmune will supply Micromet with Micromet’s
requirements of such Clinical Trial Materials at MedImmune’s [***] for such Clinical Trial
Materials for use in Europe. If Micromet orders such Clinical Trial Material for use in Pivotal
Trials, then MedImmune will manufacture any such Clinical Trial Materials using the applicable
Commercial Process or a clinical scale process, as unanimously determined by the JDC. Micromet
will provide to MedImmune rolling forecasts of its requirements of such Clinical Trial Materials.
The frequency and forward-looking time period of such forecasts will be determined by the JDC.
Micromet will place purchase orders for such
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Clinical Trial Material as needed for the performance of clinical trials by Micromet in
accordance with the applicable Development Plan. Each purchase order will specify the delivery
dates for the quantities ordered; provided, however, that MedImmune will not be required to supply
such Clinical Trial Materials earlier than a certain number of days after receipt of a purchase
order from Micromet. The number of days for the lead time will be determined by the JDC. Should
MedImmune at any time during the term of this Agreement have reason to believe that it will be
unable to meet an agreed upon delivery date of a shipment after submission of the relevant purchase
order, then MedImmune will promptly notify Micromet of the cause for such delay and the steps to be
undertaken by MedImmune to make up lost time. MedImmune will supply each of Micromet’s licensees
of Collaboration Product with such licensee’s requirements of Clinical Trial Materials at [***] for
such Clinical Trial Materials, and each such licensee will be entitled to the rights and privileges
set forth in this Agreement with respect to such Clinical Trial Material; provided, however, that
such licensee agrees to comply with the terms and conditions applicable to Micromet’s purchase of
such Clinical Trial Material hereunder from MedImmune and MedImmune is made a third party
beneficiary thereof with the right of enforcement.
7.3 Packaging, Shipping and Delivery. MedImmune will fill, release, package and label
Clinical Trial Materials for shipment using due care and in accordance with Applicable Laws and the
specifications set forth in the applicable Development Plan. Any packaging and labeling material
for such Clinical Trial Materials to be used in countries outside the Territory will be provided by
Micromet, at the cost and expense of Micromet. MedImmune will ship such Clinical Trial Materials
[***] (Incoterms 2000) MedImmune’s facility by a common carrier designated by Micromet in the
applicable purchase order. Each shipment will be made according to the delivery schedule and in
the amounts specified in the applicable purchase order, and under the terms and conditions set
forth in this Agreement. Each shipment will include a certificate of analysis and such other
documentation as may be requested on the applicable purchase order.
7.4 Risk of Loss. Risk of loss of Clinical Trial Materials will be transferred to Micromet
upon delivery to the carrier, and thereafter with respect to any loss thereof, Micromet will be
responsible for payment to MedImmune for such Clinical Trial Materials.
7.5 Invoice and Payment. MedImmune will enclose an invoice with each shipment of Clinical
Trial Materials made pursuant to this Section 7 setting forth a detailed account of the quantities
of such Clinical Trial Materials included in such shipment and a good faith estimate of the [***]
for such Clinical Trial Materials. Within [***] of acceptance by Micromet of a shipment of such
Clinical Trial Materials, Micromet will pay the full amount of the estimated [***] set forth in the
relevant invoice. Within [***] after each shipment of Clinical Trial Materials provided to
Micromet under this Section 7, MedImmune will calculate the actual [***] for such shipment and will
provide Micromet with written notice of such [***] and, within [***] of receipt of such notice,
Micromet will pay the difference between the actual [***] for such Clinical Trial Materials and the
amounts paid by Micromet based on MedImmune’s estimate of the [***] for such Clinical Trial
Materials, or MedImmune will reimburse any amount of overpayment, as the case may be.
7.6 Warranties. MedImmune hereby warrants that any Clinical Trial Materials provided by
MedImmune to Micromet under this Agreement, at the time of delivery pursuant to Section 7.3 above:
(a) will conform to the specifications for such Clinical Trial Materials set forth in the
Development Plan (the
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20
“Specifications”), and (b) will have been manufactured and shipped to Micromet in accordance
with cGMP and other Applicable Laws in Europe (the “Product Warranties”).
7.7 Acceptance of Clinical Trial Materials. Micromet will have 60 days after receipt of each
shipment of Clinical Trial Materials (such period, the “Acceptance Period”) to review such shipment
and test the Clinical Trial Materials therein. If Micromet believes that the Clinical Trial
Materials do not comply with the Product Warranties, then Micromet will deliver to MedImmune
written notice of rejection (the “Rejection Notice”) of such Clinical Trial Materials, stating in
reasonable detail the basis for such assertion of non-compliance with the Product Warranties. Any
Clinical Trial Materials not rejected within such 60 day period will be deemed to be accepted by
Micromet; provided, however, that Micromet thereafter may send a Rejection Notice for Clinical
Trial Material promptly following the discovery of any failure to comply with the Product
Warranties if (a) such non-compliance was not reasonably discoverable within such 60-day period
(each such non-compliance a “Latent Defect”), and (b) such non-compliance is discovered within 12
months following receipt by Micromet of the applicable shipment of Clinical Trial Materials. If a
Rejection Notice is received by MedImmune during the Acceptance Period, or thereafter as permitted
with respect to Latent Defects, then MedImmune and Micromet will provide one another with all
related paperwork and records (including, but not limited to, quality control tests) relating to
the production of the Clinical Trial Materials in question or the Rejection Notice.
7.8 Disputes Regarding Clinical Trial Materials.
7.8.1 MedImmune and Micromet will attempt to resolve any dispute regarding the conformity of a
shipment of Clinical Trial Materials with the Product Warranties. If such dispute cannot be
settled within 30 days of the submission by each Party of such related paperwork and records to the
other Party, then such dispute will be resolved as set forth in this Section 7.8.
7.8.2 If the Clinical Trial Materials are alleged not to conform with the Product Warranties
set forth in Section 7.6(a), then Micromet will submit a sample of the batch of the disputed
shipment to an independent testing laboratory of recognized repute selected by Micromet and
approved by MedImmune (such approval not to be unreasonably withheld) for analysis, under Quality
Assurance approved procedures, of the conformity of such shipment of Clinical Trial Materials with
the applicable Specifications. The costs associated with such analysis by such independent testing
laboratory will be paid by the Party whose assessment of the conformity of the shipment of Clinical
Trial Materials with the Specifications was mistaken. The determination by the independent testing
laboratory, will be final and binding.
7.8.3 If the Clinical Trial Materials are alleged not to conform with the Product Warranties
set forth in Section 7.6(b), then such dispute will be submitted to an arbitrator located in the
state where the Clinical Trial Materials are manufactured. Such arbitrator will have adequate
scientific background and training and will be selected jointly by Micromet and MedImmune. Such
arbitrator, in accordance with the commercial arbitration rules of JAMS, will determine whether the
Clinical Trial Materials were non-conforming with the Product Warranties set forth in Section
7.6(b), and such arbitrator’s findings, will be final and binding. The costs and expenses
associated with the retention of such arbitrator will be paid by the Party whose assessment of the
conformity of the shipment of Clinical Trial Materials with the Product Warranties was mistaken.
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7.9 Remedies for Non-Conforming Clinical Trial Materials. In the event that the Parties
agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.8,
that all or a portion of a shipment of Clinical Trial Materials materially fails to conform to the
Product Warranties, then, as the sole and exclusive remedy for such failure, Micromet will not be
obligated to make any payment for such non-conforming Clinical Trial Materials and MedImmune will
reimburse any payments for such materials previously received from Micromet. Further, MedImmune
will produce for Micromet sufficient quantities of Clinical Trial Materials to replace the
non-conforming portion of such shipment of Clinical Trial Materials, in accordance with the
provisions of this Agreement.
7.10 Audits and Inspections.
7.10.1 A delegation consisting of representatives of Micromet and its licensees that are to be
supplied Clinical Trial Materials by MedImmune under this Agreement, no more than once per calendar
year, will have the right to inspect and audit any MedImmune facility where a manufacturing process
is implemented for such Clinical Trial Materials, and the documentation generated in connection
with the manufacture and testing of such Clinical Trial Materials; provided, however, that Micromet
will be entitled to perform an additional audit in the event that an inspection by a regulatory
authority results in a determination that the facilities in which Clinical Trial Materials are
manufactured fail to comply with Applicable Law in such a manner as may affect the supply of
Clinical Trial Materials hereunder. Such inspections will take place during regular business hours
and with at least 60 days prior notice to MedImmune. Micromet will discuss the results of any
inspection with MedImmune. Any inspection by Micromet, if it occurs, does not relieve MedImmune of
its obligation to comply with all Applicable Laws and does not constitute a waiver of any right
otherwise available to Micromet.
7.10.2 Up to two representatives of Micromet and its licensees that are to be supplied
Clinical Trial Materials by MedImmune under this Agreement will have the right to be present as
silent observers at any announced visits to MedImmune by any regulatory authority relating to the
manufacture of Clinical Trial Materials. Furthermore, MedImmune will inform Micromet of the
results of any inspection by a regulatory authority that does or could reasonably be expected to
affect the manufacture of such Clinical Trial Materials. MedImmune will promptly provide Micromet
with copies of notifications from any regulatory authority (including, without limitation, any Form
No. 483 notification, Enforcement Inspection Reports, Notice of Adverse Finding, etc.). Micromet
will treat all information subject to review under this Section 7.10.2 in accordance with the
provisions of Section 15 and will cause any Third Party auditor retained by Micromet (and
reasonably acceptable to MedImmune) to enter into a reasonably acceptable confidentiality agreement
with MedImmune obligating such auditor to maintain all such information in confidence pursuant to
such confidentiality agreement.
7.11 Commercial Supply of Collaboration Product.
7.11.1 Commercial Supply Agreement. MedImmune will inform Micromet of the completion of
development of each Commercial Process. At such time, Micromet may request that MedImmune supply
Micromet or its licensees with Approved Collaboration Product manufactured using such Commercial
Process in bulk form (i.e. filled vials, unlabelled and unpackaged) for use and sale in Europe if
such Approved Collaboration Product is developed or Commercialized by Micromet or its licensees in
Europe pursuant to this Agreement. If MedImmune elects to undertake the supply of such Approved
Collaboration Product to Micromet or its licensees, then the Parties will enter into a supply
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agreement setting forth the terms and conditions of the manufacture and supply (the
“Commercial Supply Agreement”).
7.11.2 Supply Price; Royalty.
(a) Each Commercial Supply Agreement will provide that the supply price of Collaboration
Product intended for commercial sale in Europe will be [***]% of the [***] so long as such amount
exceeds [***]% of [***] of Micromet or its licensees [***]. If [***]% of [***] is less than or
equal to [***]% of [***] then the supply price will be the lesser of [***]% of [***] or [***]% of
[***] of Micromet or its licensees [***].
(b) If MedImmune has transferred a process pursuant to Section 8 below and Micromet or any of
its licensees obtains Collaboration Product for commercial sale either by manufacturing
Collaboration Product itself or by engaging a Third Party for the manufacture and supply of
Collaboration Product for commercial sale using the Commercial Process transferred by MedImmune,
without material changes thereto, then Micromet will pay MedImmune a royalty of [***]% of Net Sales
of such Collaboration Product by Micromet, its Affiliates or licensees.
(c) Notwithstanding the provisions of Section 7.11.2(b) above, Micromet will have no
obligation to pay royalties on Net Sales of a Collaboration Product in Japan if the Commercial
Process transferred to Micromet by MedImmune for such Collaboration Product, at the time of such
transfer, is not compliant with Japanese cGMP and Applicable Law.
8. Transfer of Manufacturing Process
8.1 Transfer Triggers. In accordance with Section 8.2, MedImmune will transfer to Micromet
the then-current process for producing an Approved Collaboration Product: (1) if MedImmune does not
desire to supply such Approved Collaboration Product to Micromet, or (2) upon request of Micromet.
In each case, the Party whose decision triggers the transfer will provide the other Party with
written notice at least 60 days before such transfer. MedImmune cannot provide notice under this
Section 8.1 until such time as it has completed the development of the Commercial Process for such
Approved Collaboration Product. Except upon termination of all the licenses granted to MedImmune
under this Agreement, Micromet cannot provide notice under this Section 8.1 before MedImmune has
completed the development of the applicable Commercial Process during such time as MedImmune is
developing such Commercial Process as set forth in the applicable Development Plan unanimously
approved by the JDC. Micromet will pay MedImmune: (a) upon process transfer at Micromet’s request,
a technology transfer fee equal to the amount of any reasonable and documented expenses at the FTE
Rate as well as any reasonable and documented out-of-pocket expenses incurred by MedImmune in the
course of effecting such process transfer, or (b) upon process transfer for any other reason under
this Section 8.1, a technology transfer fee equal to the amount of any reasonable and documented
out-of-pocket expenses incurred by MedImmune in the course of effecting such process transfer. For
the avoidance of doubt, no payment shall be due under the preceding sentence if the transfer
results from a termination of the licenses granted to MedImmune in the entirety pursuant to Section
17.2.
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23
8.2 Manufacture During Process Transfer. During any manufacturing process transfer made
pursuant to Section 8.1 above and until such time as Micromet or a contract manufacturer designated
by Micromet has established and validated the transferred process and is approved to manufacture
commercial supplies of the applicable Approved Collaboration Product (but in no event longer than
[***] after the applicable triggering event described in Section 8.1 above), MedImmune will
continue to supply such Approved Collaboration Product to Micromet at [***] for Clinical Trial
Materials of such Approved Collaboration Product, and at the supply price set forth in Section
7.11.2 pursuant to the Commercial Supply Agreement. Except as provided in this Section 8.2, upon
receipt of the written notice pursuant to Section 8.1, MedImmune will no longer have an obligation
to manufacture such Approved Collaboration Product for Micromet.
8.3 Technology Transfer. As part of any manufacturing process transfer made pursuant to this
Section 8, MedImmune will provide Micromet with technical reports and materials for process
development activities completed at the time of such transfer that are relevant to and would be
required to perform the applicable process as performed by MedImmune at such time and for
regulatory filings (including but not limited to any master cell banks, working cell banks,
fermentation processes, recovery steps established, process validation, product identity assays,
in-process-control assays, relevant standard operating procedures, blueprints of facilities,
information regarding equipment and the layout thereof, etc.), as well as samples of the working
cell bank prepared at MedImmune, and technical methods for assays required for the applicable
process. At the option of MedImmune in lieu of providing Micromet with recipes for the cell
culture media and nutrient feeds used in the applicable process, MedImmune itself or though a Third
Party may provide Micromet at cost with such cell culture media and nutrient feeds. Micromet will
not, directly or indirectly, take any steps to ascertain the recipe of any such cell culture media
or nutrient feeds provided by MedImmune. MedImmune will provide to Micromet, or at the discretion
of MedImmune to the applicable regulatory agencies in Europe, all necessary CMC documentation
relating to such cell culture media and nutrient feeds required for regulatory filings for the
applicable Approved Collaboration Product for Europe.
8.4 Subsequent Process Transfer by Micromet. To the extent that Micromet has rights under
this Agreement to use a Commercial Process for the manufacture of a Collaboration Product, Micromet
will have the right to use a Third Party to manufacture Collaboration Product by means of a
Commercial Process transferred to Micromet pursuant to this Section 8 and to transfer to such Third
Party the Know-How transferred to Micromet by MedImmune in connection with the transfer of such
Commercial Process; provided, however, that such Third Party enters into a confidentiality
agreement with MedImmune containing confidentiality and non-use obligations substantially similar
to those set forth in this Agreement with respect to Confidential Information of MedImmune.
9. Commercialization of Collaboration Products
9.1 Commercialization Rights and Responsibilities. Subject to Micromet’s right to
Commercialize Approved Collaboration Products binding to Non-Proprietary Targets in Europe and
Micromet’s Co-Promotion Option under Section 5, as between the Parties, MedImmune will have the
sole right to Commercialize Approved Collaboration Products anywhere in the world, and conduct all
activities necessary to maintain Marketing Approvals for Approved Collaboration Products anywhere
in the world,
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24
including communicating and preparing and filing all reports (including without limitation
adverse drug experience reports) with the appropriate regulatory authorities.
9.2 Diligence.
9.2.1 MedImmune will use Commercially Reasonable Efforts to Commercialize Approved
Collaboration Product in any country in the Territory, and in each country of the Territory in
which MedImmune receives Marketing Approval for such Approved Collaboration Product.
9.2.2 If Micromet determines that MedImmune is not Commercializing an Approved Collaboration
Product in a particular country of the Territory as required under Section 9.2.1, then, as the sole
and exclusive remedy for such failure, Micromet will have the right to terminate the licenses
granted to MedImmune under this Agreement with respect to such Collaboration Product in such
country, as set forth in Section 17.2.
9.2.3 Micromet will use Commercially Reasonable Efforts to Commercialize Approved
Collaboration Product in any country in Europe in which Micromet receives Marketing Approval for
such Approved Collaboration Product.
9.2.4 If MedImmune determines that Micromet is not Commercializing an Approved Collaboration
Product in a particular country of Europe as required under Section 9.2.3, then, as the sole and
exclusive remedy for such failure, MedImmune will have the right to terminate the licenses granted
to Micromet under this Agreement with respect to such Approved Collaboration Product and such
country, as set forth in Section 17.2.
9.2.5 Adverse Drug Experiences. To the extent either Party receives any information regarding
adverse drug experiences related to the use of an Approved Collaboration Product, such Party will
promptly provide the other Party with such information as is required under Applicable Laws. Prior
to the first commercial launch of an Approved Collaboration Product by either Party, the Parties
will agree on standard operating procedures implementing the requirements under Applicable Laws
regarding adverse event reporting, which procedures, as may be amended from time to time upon
mutual agreement of the Parties, will be incorporated in this Agreement by reference.
9.3 Branding, Trademarks, Trade Dress, and Logos.
9.3.1 Except as provided in Section 9.3.2, MedImmune will have sole responsibility for all
trademarks, trade dress, logos, slogans, and designs used on and in connection with Approved
Collaboration Products in the Territory. MedImmune will be the sole owner of all trademarks, trade
dress, logos, slogans, designs and copyrights developed for or used on or in connection with the
marketing and sale of such Collaboration Products in the Territory. Except as provided in Section
9.3.2, MedImmune will select the trademark used to identify such Collaboration Products that will
be sold in the Territory pursuant to this Agreement. MedImmune will oversee the filing,
prosecution and maintenance of all trademark registrations for such Collaboration Products in the
Territory. MedImmune will be responsible for the payment of any and all costs relating to filing,
prosecution, and maintenance of the trademarks for such Collaboration Products in the Territory.
9.3.2 Micromet will have sole responsibility for all trademarks, trade dress, logos, slogans,
and designs used on and in connection with Approved Collaboration Products binding to a
Non-Proprietary
25
Target in Europe. Micromet will be the sole owner of all trademarks, trade dress, logos,
slogans, designs and copyrights developed for or used on or in connection with the
Commercialization of such Collaboration Products in Europe. Micromet will select the trademark
used to identify such Collaboration Products that will be Commercialized in Europe pursuant to this
Agreement. Micromet will oversee the filing, prosecution and maintenance of all trademark
registrations for such Collaboration Products in Europe. Micromet will be responsible for the
payment of any and all costs relating to filing, prosecution, and maintenance of the trademarks for
such Collaboration Products in Europe.
10. Ownership of Intellectual Property; Acquisition of Third Party Intellectual Property
10.1 Ownership by Micromet. Micromet will own all right, title, and interest in and to the
Independent Micromet Technology and Micromet Collaboration Technology, subject only to the licenses
granted to MedImmune in this Agreement. Micromet will promptly disclose to MedImmune in writing,
and will cause its Affiliates, agents and independent contractors to so disclose to Micromet, the
development, making, conception or reduction to practice of any Patents within Micromet
Collaboration Technology.
10.2 Ownership by MedImmune. MedImmune will own all right, title, and interest in and to any
Independent MedImmune Technology, MedImmune Process Technology, and MedImmune Collaboration
Technology, subject only to the licenses granted to Micromet in this Agreement. MedImmune will
promptly disclose to Micromet in writing, and will cause its Affiliates, agents and independent
contractors to disclose to MedImmune, the development, making, conception or reduction to practice
of any Patents within MedImmune Collaboration Technology.
10.3 Joint Ownership. Micromet and MedImmune will each own an undivided 50% interest in any
Joint Collaboration 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
Joint Collaboration Technology, in each case subject to the licenses granted in this Agreement.
Each Party will promptly disclose to the other Party in writing, and will cause its Affiliates,
agents and independent contractors to so disclose to it, the development, making, conception or
reduction to practice of any Joint Collaboration Technology.
10.4 Further Acts. Each Party will take all necessary and proper acts, and will cause its
employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to
effectuate the ownership provisions provided in this Section 10.
10.5 Third Party Technology.
10.5.1 Consent.
(a) After the Effective Date, if a Party intends to negotiate a Technology Acquisition
Agreement that, at such time, is applicable to a Collaboration Product, such Party will keep the
other Party advised of such negotiation. It is expressly understood that the Party negotiating the
Technology Acquisition Agreement will make the final determination as to the terms thereof and
whether or not to enter into such Technology Acquisition Agreement, and the other Party will not
interfere with such negotiation or the ability of the Party to enter into such Technology
Acquisition Agreement.
26
(b) The Party negotiating the Technology Acquisition Agreement will use reasonable efforts to
secure a license that is sublicensable to the other Party on the same terms and conditions
applicable to the negotiating Party.
(c) Promptly upon execution by a Party of any Technology Acquisition Agreement under which the
other Party receives a sublicense under this Agreement, the Party that executed such Technology
Acquisition Agreement will provide to the other Party a complete copy of such Technology
Acquisition Agreement.
10.5.2 Terms and Maintenance. Each Party hereby covenants and agrees that: (i) it will not
consent to any amendment or modification or termination of any Technology Acquisition Agreement
that would adversely affect the licenses granted to the other Party hereunder without the written
permission of such other Party; (ii) it will perform its contractual obligations to keep any
Technology Acquisition Agreement in full force and effect during the respective terms thereof;
(iii) it will not assign any Technology Acquisition Agreement without the written consent of the
other Party (which consent will not be unreasonably withheld), except that such consent will not be
required for assignment in connection with the transfer or sale of all or substantially all of its
business, or in the event of its merger, consolidation, change in control or similar transaction,
(x) provided that such assignment is subject to this Agreement and (y) such assignment does not
adversely affect the Technology Acquisition Agreement or either Party’s rights thereunder; and (iv)
it will promptly advise the other Party of any notice of a breach or intent to terminate any
Technology Acquisition Agreement that is received, and to the extent permitted under the Technology
Acquisition Agreement, such other Party will have the right but not the obligation to cure any such
breach. Notwithstanding the foregoing, MedImmune’s obligations under this Section 10.5.2 only
apply to Technology Acquisition Agreements that affect (a) an Approved Collaboration Product
against a Non-Proprietary Target in Europe or a process for producing such Collaboration Product
for Europe and/or (b) an Approved Collaboration Product against a Proprietary Target in Europe to
the extent that Micromet has and maintains co-promotion or Commercialization rights thereto.
10.5.3 Technology Acquisition Payments.
(a) MedImmune will be responsible for and will make any Technology Acquisition Payments
arising in connection with the development or Commercialization of Approved Collaboration Products
in the Territory under its own Technology Acquisition Agreements and under any Technology
Acquisition Agreements of Micromet pursuant to which Licensed Technology is licensed to MedImmune
under this Agreement; provided, however, that MedImmune may deduct a portion of these Technology
Acquisition Payments paid by MedImmune from royalties payable to Micromet under this Agreement, as
set forth in Section 13.2.3(b). Each such Technology Acquisition Payment due under a Technology
Acquisition Agreement of Micromet will be due and payable as set forth in the applicable Technology
Acquisition Agreement and will be paid by MedImmune to Micromet.
(b) Micromet will be responsible for and will make any Technology Acquisition Payments arising
in connection with the development or Commercialization of Approved Collaboration Products outside
the Territory under its own Technology Acquisition Agreements and under any Technology Acquisition
Agreements pursuant to which Micromet holds a license under this Agreement. Each such Technology
Acquisition Payment due under a Technology Acquisition Agreement of MedImmune will be due and
payable as set forth in the applicable Technology Acquisition Agreement and will be paid by
Micromet to MedImmune.
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(c) Each Party has the right to notify the other Party that the notifying Party desires to
terminate its license under one or more of the other Party’s Technology Acquisition Agreements, in
which case such license will be terminated and the notifying Party will no longer be obligated to
make payments for such license.
11. License Grants
11.1 Licenses granted by Micromet.
11.1.1 Subject to Section 4.7 and the other terms and conditions set forth in this Agreement,
Micromet hereby grants to MedImmune an exclusive (even as to Micromet), royalty-bearing right and
license under the Licensed Technology, to make, have made, use, offer for sale, sell, and import
Collaboration Products in the Territory for any use in humans.
11.1.2 MedImmune hereby covenants and agrees not to use any confidential Know-How that is
Licensed Technology, nor grant any Third Party any license or right under confidential Know-How
that is Independent Micromet Technology or Micromet Collaboration Technology, to develop or
Commercialize any product other than Collaboration Products without Micromet’s written consent, and
not otherwise to use or practice the confidential Know-How that is Independent Micromet Technology
or Micromet Collaboration Technology except as expressly permitted by this Agreement.
11.1.3 Subject to the terms and conditions set forth in this Agreement, Micromet hereby grants
to MedImmune a worldwide, co-exclusive (with Micromet), royalty-free right and license, with the
right to grant sublicenses, under the Micromet Collaboration Technology to make, have made, use,
offer for sale, sell, and import any product that is not a BiTE Product for any use in humans. The
license set forth in this Section 11.1.3 is exclusive except as to Micromet and its permitted
licensees under Section 11.4 below.
11.1.4 MedImmune will have the right to grant sublicenses under the licenses granted in
Section 11.1.1, provided that each such sublicense grant will be made subject to the terms of this
Agreement. If a sublicensee of MedImmune commits any act or omission relating to (a) Micromet’s
Confidential Information disclosed by MedImmune to such sublicensee, (b) the practice of the
sublicense granted by MedImmune under the licenses granted to it in this Agreement to such
sublicensee outside the limited geographic and product-related scope thereof, or (d) the
misappropriation of Micromet’s confidential Know-How, which act or omission, if committed by
MedImmune, would constitute a material breach of this Agreement, then MedImmune will, upon request
of Micromet, terminate the sublicense agreement with such sublicensee. Promptly upon execution of
each agreement under which MedImmune grants a sublicense under the licenses granted by Micromet to
MedImmune under this Agreement, MedImmune will provide to Micromet a complete copy of such
sublicense agreement.
11.2 Licenses granted by MedImmune.
11.2.1 Subject to the terms and conditions set forth in this Agreement and subject to the
payment obligations of this Agreement including Sections 6.1.3, 7.11.2 and 10.5.3, MedImmune hereby
grants to Micromet an exclusive (even as to MedImmune), royalty-free, right and license, with the
right to grant and authorize the grant of sublicenses, under the Independent MedImmune Technology,
MedImmune’s rights and interest in the Joint Collaboration Technology, and the MedImmune
Collaboration Technology to use, offer for sale, sell, and import Collaboration Products that bind
to a Non-Proprietary Target for any use in humans, but only for sale and use in Europe.
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11.2.2 Subject to the terms and conditions set forth in this Agreement, MedImmune hereby
grants to Micromet a worldwide, co-exclusive (with MedImmune), royalty-free right and license, with
the right to grant and authorize the grant of sublicenses, under MedImmune’s rights and interest in
the Joint Collaboration Technology and the MedImmune Collaboration Technology to make, have made,
use, offer for sale, sell, and import any BiTE Product (other than any Collaboration Product, or
any BiTE Product as to which MedImmune is exclusively licensed under an agreement with Micromet)
for any use in humans. The license set forth in this Section 11.2.2 is exclusive except as to
MedImmune and its permitted licensees under Section 11.3 below.
11.2.3 Upon transfer of a manufacturing process to Micromet in accordance with Section 8 of
this Agreement and subject to the payment obligations of Sections 7.11.2 and 10.5.3, MedImmune
hereby grants to Micromet an exclusive (even as to MedImmune, but not as to sublicensees of
Micromet that receive a direct license from MedImmune upon Micromet’s request pursuant to Section
11.2.4), royalty-bearing right and license, without the right to grant sublicenses, under
Independent MedImmune Technology, MedImmune Collaboration Technology, MedImmune Process Technology,
and MedImmune’s rights and interest in the Joint Collaboration Technology to use such manufacturing
process to make and have made Approved Collaboration Products against a Non-Proprietary Target for
sale and use in Europe.
11.2.4 In the event that Micromet grants a license in Europe to a Third Party for an Approved
Collaboration Product, and Micromet has a license under this Section 11.2 to the applicable
Commercial Process for such Approved Collaboration Product, then, upon request by Micromet,
MedImmune will grant such Third Party a license under Independent MedImmune Technology, MedImmune
Collaboration Technology, MedImmune Process Technology, and MedImmune’s right and interest in the
Joint Technology to use such Commercial Process to make and have made the applicable Collaboration
Product for sale and use in Europe. The commercial terms of each such license will be the same as
the terms set forth in Sections 7.11.2 and 8, as applicable, and the remaining terms will be
negotiated in good faith between MedImmune and such Third Party. In addition, MedImmune will
transfer the Commercial Process to such Third Party pursuant to the terms, mutatis mutandis, of
Section 8.
11.2.5 If a sublicensee of Micromet commits any act or omission relating to (a) MedImmune’s
Confidential Information disclosed by Micromet to such sublicensee, (b) the practice of the
sublicense granted by Micromet under the licenses granted to it in this Agreement to such
sublicensee outside the limited geographic and product-related scope thereof, or (d) the
misappropriation of MedImmune’s confidential Know-How, which act or omission, if committed by
Micromet, would constitute a material breach of this Agreement, then Micromet will, upon request of
MedImmune, terminate the sublicense agreement with such sublicensee. Promptly upon execution of
each agreement under which Micromet grants a sublicense under the licenses granted by MedImmune to
Micromet under this Agreement, Micromet will provide to MedImmune a complete copy of such
sublicense agreement.
11.2.6 Micromet hereby covenants and agrees not to use any confidential Know-How that is
Independent MedImmune Technology or MedImmune Collaboration Technology, nor grant any Third Party
any license or right under confidential Know-How that is Independent MedImmune Technology or
MedImmune Collaboration Technology, to develop or Commercialize any product other than
Collaboration Product outside the Territory without MedImmune’s written consent, and not otherwise
to use or practice the confidential Know-How that is Independent MedImmune Technology or MedImmune
Collaboration Technology except as expressly permitted by this Agreement.
29
11.3 Limitations on MedImmune’s Ability to License. MedImmune hereby covenants and agrees
that it will not license, assign or otherwise transfer to any Third Party any of its right and
interest in and to the Joint Collaboration Technology or the MedImmune Collaboration Technology for
research, development, manufacture, use or Commercialization of any BiTE Product, except in
connection with co-developing one or more BiTE Products with such Third Party or with respect to
Collaboration Product in the Territory. This limitation is not applicable to any Approved
Collaboration Product as to which MedImmune holds a license under this Agreement or any “Licensed
Product,” as that term is defined in that certain Collaboration and License Agreement executed by
the Parties on the Effective Date.
11.4 Limitations on Micromet’s Ability to License. Micromet hereby covenants and agrees that
it will not license, assign or otherwise transfer to any Third Party any of its right and interest
in and to the Joint Collaboration Technology or the Micromet Collaboration Technology for research,
development, manufacture, use or Commercialization of any product that is not a BiTE Product,
except in connection with co-developing such product with such Third Party.
11.5 Option for Exclusive License to [***] Patent.
11.5.1 Grant of Option. Micromet hereby grants MedImmune an exclusive option to obtain an
exclusive, royalty-bearing right and license under the [***] Patent, to make, have made, use, offer
for sale, sell, and import Collaboration Products in the United States for any use in humans.
MedImmune may exercise the option at any time during the term of this Agreement by providing
written notice to Micromet.
11.5.2 Financial Terms. MedImmune will make any payments due by Micromet to Upstream
Licensor; provided, however, that Micromet will remain solely responsible for the payment of any
annual license maintenance fees; and provided, further, that any payments due from Micromet to the
Upstream Licensor as a result of receiving royalties on Net Sales from MedImmune may be off-set
against royalties due to Micromet under this Agreement as provided in Section 10.5.3(b).
11.6 Bankruptcy Provision under German Law.
11.6.1 In the event that Micromet becomes insolvent, has to file for insolvency or is
adjudicated insolvent, Micromet, its legal successor or the insolvency administrator will, to the
extent legally possible, use commercially reasonable endeavors to ensure that MedImmune retains the
licensing rights based on Licensed Technology owned by Micromet granted to MedImmune under this
Agreement. Except for any mandatory law, in such event MedImmune will continue to use the
licensing rights in accordance with the terms set out in this Agreement.
11.6.2 In relation to licensing rights granted to MedImmune which are based on Licensed
Technology that Micromet licenses from Third Parties, Micromet or its legal successor or the
insolvency administrator will, to the extent legally possible, use commercially reasonable
endeavors to secure the retention of the licensing rights granted to MedImmune. Except for any
mandatory law, depending on the terms of the license agreement between Micromet and the relevant
Third Party Micromet, its legal successor or the insolvency administrator will use its commercially
reasonable endeavors to assign or transfer all its rights or obligations under the relevant
licensing agreement between Micromet and the relevant Third Party
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to MedImmune. Alternatively, Micromet or its legal successor or the insolvency administrator
will use its commercially reasonable endeavors to convince the relevant Third Party to enter into
negotiations with MedImmune in order to cause the conclusion of the appropriate license agreements
between the relevant Third Party and MedImmune.
11.7 Bankruptcy Provision under US Law. All rights and licenses granted under or pursuant to
this Agreement, including amendments hereto, by MedImmune to Micromet are, for all purposes of
Section 365(n) of Title 11 of the U.S. Code (“Title 11”), licenses of rights to intellectual
property as defined in Title 11. All rights, powers and remedies of Micromet provided in this
Section 11.7 are in addition to and not in substitution for any and all other rights, powers and
remedies now or hereafter existing at law or in equity (including, without limitation Title 11) in
the event of the commencement of a Title 11 case by or against MedImmune. In such event, Micromet
will be entitled to exercise all other such rights and powers and resort to all other such remedies
as may now or hereafter exist at law or in equity (including, without limitation, under Title 11).
11.8 First Offer. In the event that Micromet decides to transfer ownership of Micromet
Collaboration Technology to a Third Party, Micromet will first offer ownership in and to such
Micromet Collaboration Technology to MedImmune by written notice to MedImmune and if, within [***]
after such written notice, MedImmune notifies Micromet that MedImmune has an interest in acquiring
the Micromet Collaboration Technology, then for a period of [***] thereafter, the Parties will
negotiate in good faith the terms and conditions of such acquisition. If the Parties do not reach
agreement on such terms and conditions within a period of [***] after such written notice from
MedImmune, then for a period of [***] thereafter Micromet will have the right to transfer ownership
to the Micromet Collaboration Technology to a Third Party without re-offering such rights to
MedImmune; provided, however, that during such [***] period, Micromet will not transfer the
applicable rights to a Third Party on financial terms and conditions that, in the aggregate, are no
more favorable to the Third Party or equal to MedImmune’s final offer to Micromet. This clause
does not apply to any assignment of this Agreement by Micromet or any sale by Micromet of
substantially all of Micromet’s assets pertaining to a Collaboration Product, each as set forth in
Section 22.2.
11.9 Disclosure of Micromet Core Technology. For the avoidance of doubt, Micromet will not
have any obligation under this Agreement to disclose or transfer any Know-How relating to creation
or characterization of BiTE Molecules, including protein engineering, the selection or
determination of the amino acid sequence of proteins relevant for the function of BiTE Molecules,
except as necessary to perform the development of an Approved Collaboration Product under a
Development Plan.
12. Prosecution, Enforcement and Defense of Patents
12.1 Prosecution and Maintenance of Patents.
12.1.1 Micromet will have the sole right to file, prosecute and maintain Patents in the
Independent Micromet Technology and Micromet Collaboration Technology. MedImmune will cooperate
with Micromet to file, prosecute and maintain such Patents, and will have the right to review and
provide comments to Micromet relating to such patent applications and patents.
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12.1.2 MedImmune will have the sole right to file, prosecute and maintain Patents in the Joint
Collaboration Technology. Micromet will reimburse MedImmune for [***]% of MedImmune’s reasonable
and documented out-of-pocket costs incurred in connection with the filing and prosecution of
Patents included in the Joint Collaboration Technology. Micromet will cooperate with MedImmune to
file, prosecute and maintain such Patents, and will have the right to review and provide comments
to MedImmune relating to such patent applications and patents.
12.1.3 For all other Patents, the person or entity owning the Patent will pay the costs and
expenses thereof.
12.1.4 With respect to Patents in the Licensed Technology or Patents in MedImmune
Collaboration Technology, each Party will provide to the other Party all documents that relate to
patent filing, prosecution and maintenance, including, but not limited to, each patent application,
office action, response to office action, request for terminal disclaimer, and request for reissue
or reexamination or extension of any patent issuing from such application sufficiently prior to the
filing of such application, response or request to allow for review and comment by such other
Party, except to the extent that the filing Party is prohibited from doing so under a Technology
Acquisition Agreement. The filing Party agrees to consider and take into account all comments
received from the other Party.
12.1.5 Micromet will not withdraw or abandon any Patent in the Licensed Technology in the
Territory, without MedImmune’s prior written consent, and at the request of MedImmune, Micromet
will file continuation and divisional applications, except to the extent that Micromet is
prohibited from doing so under a Technology Acquisition Agreement.
12.2 Enforcement of Patents.
12.2.1 Notice. If either Party learns that a Third Party is infringing or allegedly
infringing any Patent within the Micromet Independent Technology, MedImmune Independent Technology,
or Collaboration 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.
12.2.2 Enforcement Actions for Micromet Technology.
(a) Outside the Territory, Micromet will have the sole right (but not the obligation) to take
the appropriate steps to remove the infringement or alleged infringement of Licensed Technology,
including by initiation, prosecution and control at its own expense of any suit, proceeding or
other legal action by counsel of its own choice. MedImmune will have the right, at its own
expense, to be represented in any such action by counsel of its own choice.
(b) Except as described in Section 12.2.2(a), with respect to the alleged infringement of
Licensed Technology by Collaboration Products developed or Commercialized by a Third Party, and
subject to the rights of any licensor of Licensed Technology under Technology Acquisition
Agreements with Micromet, MedImmune will have the first right (but not the obligation) to bring any
infringement action or proceeding within the Territory, at the cost and expense of MedImmune, by
counsel
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32
of its own choice. Micromet will have the right, at its own cost and expense, to be
represented in any such action by counsel of its own choice. If MedImmune fails to bring such an
action in the Territory within 180 days of written notice thereof from Micromet to MedImmune, then
Micromet will have the right to bring such action at the cost and expense of Micromet with counsel
selected by Micromet. MedImmune, at its cost and expense, will have the right to be represented by
counsel in any such action brought by Micromet.
12.2.3 Enforcement Actions for MedImmune Technology. MedImmune will have the first right (but
not the obligation) to take the appropriate steps to remove the infringement or alleged
infringement of Independent MedImmune Technology and MedImmune Collaboration Technology, including
by initiation, prosecution and control at its own expense of any suit, proceeding or other legal
action by counsel of its own choice. Micromet will have the right, at its own expense, to be
represented in any such action by counsel of its own choice. If MedImmune fails to bring such an
action in the Territory within 180 days of written notice thereof from Micromet to MedImmune under
MedImmune Collaboration Technology with respect to a Third Party making, using, selling, offering
for sale or importing a Collaboration Product, then Micromet will have the right to bring such
action at the cost and expense of Micromet with counsel selected by Micromet. MedImmune, at its
cost and expense, will have the right to be represented by counsel in any such action brought by
Micromet.
12.2.4 Cooperation; Damages. If one Party brings any enforcement action or proceeding under
this Section 12 with respect to a Collaboration Product, the other Party agrees to be joined as
party plaintiff if necessary to prosecute the action or proceeding and to give the first Party
reasonable assistance and authority to file and prosecute the suit; provided, however, that neither
Party will be required to transfer any right, title or interest in or to any property to the other
Party or any other party to confer standing on a Party hereunder. The Party bringing the action
will have the right to control such action, including the settlement thereof, provided, however,
that no settlement will be made that adversely affects the validity, enforceability or scope of a
Patent included in Licensed Technology unless agreed to in writing by both Parties. Any damages or
other monetary awards recovered pursuant to any suit, proceeding or other legal action taken under
this Section 12.2 will be allocated first to the costs and expenses of the Party bringing suit, and
second to the costs and expenses (if any) of the other Party that were authorized by the Party
bringing the suit, with any remaining amounts (if any) to be allocated to the Party bringing suit
and if the amount is allocated to MedImmune, such amount will be Net Sales subject to royalty under
this Agreement.
12.3 Third Party Patents. If any notice of infringement is received by, or a suit is
initiated against, either Party with respect to a Collaboration Product, the Parties will consult
in good faith regarding the best response. In each case, the Party that is sued will have the sole
right to defend such action. If MedImmune is required to make any payments to any Third Party with
respect to the development, manufacture, use or sale of a Collaboration Product as a result of such
action, MedImmune will be entitled to offset such payments against the royalties otherwise due and
payable by MedImmune under this Agreement to Micromet as provided in Section 13.2.3.
13. Fees and Payments
13.1 Development Milestones. MedImmune will make the following non-refundable, non-creditable
payments to Micromet in the amounts set forth below within 15 days of the occurrence of the
following events with respect to each Collaboration Product:
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Milestone Event | Milestone Payment | |||
1. Upon achievement of the preclinical proof of concept criteria, as
established unanimously by the JDC and set forth in the applicable
Research Plan |
US$[***] | |||
2. Upon filing of the first IND in the United States |
US$[***] | |||
3. First patient enrolled in first Pivotal Trial for the United
States |
US$[***] | |||
4. Filing of first BLA in the United States |
US$[***] | |||
5. Approval of first BLA in the United States |
US$[***] | |||
6. Approval of first MAA in Europe |
US$[***]* |
* | This milestone payment is waived by Micromet if Micromet or a Third Party licensee of Micromet is the sponsor of such MAA pursuant to clause (b) of Section 4.2. |
13.2 Royalties.
13.2.1 Royalty Rates. Subject to the adjustments provided for in Section 13.2.3, MedImmune
will pay to Micromet:
(a) a royalty equal to [***]% of Net Sales of each Collaboration Product in the Territory sold
by MedImmune, its Affiliates or their sublicensees for that portion of the total amount of
aggregate Net Sales of that Collaboration Product in the Territory in a calendar year that is less
than or equal to US$[***];
(b) a royalty equal to [***]% of Net Sales of each Collaboration Product in the Territory sold
by MedImmune, its Affiliates or their sublicensees for that portion of the total amount of
aggregate Net Sales of that Collaboration Product in the Territory in a calendar year that is
greater than US$[***];
(c) in addition to the royalties payable pursuant to Sections 13.2.1(a) and (b) above, a
royalty equal to [***]% of Net Sales of each Collaboration Product sold by MedImmune, its
Affiliates or their sublicensees in a country for which Micromet’s co-promotion rights have been
terminated under Section 5.4.4.
(d) It is expressly understood that no royalties will be due from MedImmune under any of
Sections 13.2.1(a), (b) or (c) to the extent payments are due under Section 5.4.3 or Section 13.3.
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(e) In the event that a Collaboration Product is sold in combination with a therapeutically
active component that is not a Collaboration Product (“Combination Product”), then net sales
(calculated as Net Sales) of such Combination Product upon which a royalty is paid will be subject
to the following adjustment. If the Collaboration Product and the other therapeutically active
component of the Combination Product are sold separately in a country, then net sales of such
Combination Product in such country upon which a royalty is paid will be multiplied by the fraction
A/A+B, where A equals the average sales price of such Collaboration Product sold separately in such
country, and B equals the average sales price of the other therapeutically active component sold
separately in such country. Otherwise, the parties will enter into good faith negotiations and
attempt to reach mutual agreement to determine an appropriate adjustment to the net sales of such
Combination Product in a country to reflect the relative contributions of the Collaboration Product
and the other therapeutically active component to the value of the Combination Product in such
country. If such mutual agreement is not reached within 90 days after commencement of such
negotiations, then the determination will be submitted to binding arbitration under Section 22.4.
(f) Only one royalty will be due and payable for the manufacture, use and sale of
Collaboration Product irrespective of the number of Valid Claims within the Licensed Technology
that cover the manufacture, use and sale of Collaboration Product. Upon payment of a royalty under
this Agreement with respect to a unit of Collaboration Product, no further royalty will be due with
respect to such unit of Collaboration Product.
13.2.2 Royalty Term.
(a) Royalties due under Section 13.2.1(a) and (b), and if applicable Section 5.4.3, will
continue until the later of: (i) the expiration of the last-to-expire Patent within the Licensed
Technology containing a Valid Claim claiming or covering such Collaboration Product in the country
of the Territory where sold, or (ii) 10 years from the first commercial sale of such Collaboration
Product in such country of the Territory.
(b) Royalties due under Section 13.2.1(c) for a particular Collaboration Product will continue
until the cumulative amount of such royalties paid to Micromet equals [***], plus an interest
charge of [***]% compounded annually on [***]; provided, however, that if Micromet’s co-promotion
rights with respect to one or more countries have been terminated by MedImmune pursuant to Section
5.4.4 above, the [***], as determined by the Parties in the Co-Promotion Agreement.
(c) The royalty rate adjustments set forth in Sections 13.2.2(a) and (b) are not cumulative
and in no event will the application of one or both of such adjustments reduce the royalty payable
by MedImmune pursuant to Section 13.2.1 on Collaboration Product to less than [***]% of Net Sales
of Collaboration Product.
13.2.3 Royalty Adjustments.
(a) In the event that one or more Third Parties sell a Collaboration Product in a country of
the Territory that does not infringe a Valid Claim of a Patent that is Licensed Technology and the
sales of such Collaboration Product by such Third Parties amounts to [***]% of aggregate sales of
such
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Collaboration Product in such country in a calendar year by MedImmune, its Affiliates and
sublicensees, then the royalty payable by MedImmune pursuant to Section 5.4.3 or 13.2.1 on such
Collaboration Product in such country for such calendar year will be reduced to [***]%. If sales
by such Third Parties are only for a portion of a calendar year, the [***]% of sales by MedImmune,
its Affiliates and sublicensees will be determined over such portion of the calendar year.
(b) MedImmune may credit up to [***]% of any Technology Acquisition Payments that may become
due as a result of the development or Commercialization of Collaboration Product by MedImmune
against the amount of any royalties due and payable by MedImmune pursuant to Section 5.4.3 or
13.2.1; provided, however, that in no event will such credit reduce the amount of royalties due and
payable by MedImmune to Micromet (i) under Section 13.2.1, to less than [***]% of Net Sales of
Collaboration Product, or (ii) under Section 5.4.3, to less than [***]% of Net Sales of
Collaboration Product.
13.3 Profit Sharing. If Micromet exercises the Co-Promotion Option with respect to a
Collaboration Product and retains such co-promotion rights therefor in one or more countries of
Europe, MedImmune will pay to Micromet an amount corresponding to [***]% of Net Profits of such
Collaboration Product sold by MedImmune, its Affiliates or sublicensees in such countries.
14. Payment Terms
14.1 Payment Method. All amounts due to Micromet will be paid in EURO and those due to
MedImmune will be paid in United States Dollars, in each case by wire transfer in immediately
available funds to an account designated by the Party that is the payee. The conversion for
royalties will be made at the exchange rate reported in The Wall Street Journal, Eastern Edition on
the last business day of the calendar quarter for which royalties are payable, and in all other
cases at such exchange rate on the date that the payment is due. Any payments or portions thereof
due hereunder which are not paid on the date such payments are due under this Agreement will bear
interest at the lower of (i) [***]% over the overnight LIBOR rate 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.
14.2 Payment Schedules; Reports. Payments due pursuant to Sections 5.4.3, 6.1.3, 7.11.2,
13.2, and 13.3 are due and payable within [***] of the end of each calendar quarter during the Term
during which there were Net Sales in the Territory or Net Profits in Europe. Each payment will be
accompanied with a report containing a detailed account of the calculation of such Net Sales and
Net Profits.
14.3 Records Retention; Audit.
14.3.1 Record Retention. Each Party will maintain complete and accurate books, records and
accounts used for the determination of Net Sales and any expenses incurred in connection with the
performance of the Research Plans and Development Plans, 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 [***] years after the end of the period to which such books, records
and accounts pertain.
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14.3.2 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 as may be reasonably necessary to verify the accuracy of any payments
made to or received from the other Party 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 [***].
The accounting firm will disclose to the Parties only whether the 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 audited Party’s favor of more than [***]%, in which case the audited Party
will bear the cost of the audit. The results of such accounting firm will be final, absent
manifest error.
14.3.3 Payment of Additional Amounts. If, based on the results of any audit, additional
payments are owed to a Party under this Agreement, the amount of such payments will be credited
against future amounts payable by such Party to the other Party under this Agreement; provided,
however, that if such additional payments are not fully credited within [***] months after the
receipt of the applicable audit results, the Party owing such additional payments will at such time
pay the other Party any uncredited amounts thereof.
14.3.4 Confidentiality. Each Party will treat all information subject to review under this
Section 14.3 in accordance with the provisions of Section 15 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.
15. Confidentiality
15.1 Definition. “Confidential Information” means (a) any Know-How, and (b) any scientific,
manufacturing, marketing and business plans, and financial and personnel matters relating to a
Party or its present or future products, sales, suppliers, customers, employees, investors or
business; in either case, that has been disclosed by or on behalf of such Party to the other Party
either in connection with the discussions and negotiations pertaining to this Agreement or in the
course of performing this Agreement (including any information disclosed under the Confidentiality
Agreement between the Parties dated December 11, 2002).
15.2 Exclusions.
15.2.1 Notwithstanding the foregoing, any information of a Party will not be deemed
Confidential Information with respect to a receiving Party for purposes of this Agreement if such
information:
(a) was already known or available to the receiving Party or its Affiliates, other than under
an obligation of confidentiality or non-use to the other Party, at the time of disclosure to the
receiving Party;
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(b) was generally available or known to parties reasonably skilled in the field to which such
information pertains, or was otherwise part of the public domain, at the time of its disclosure to
the receiving Party;
(c) became generally available or known to parties reasonably skilled in the field to which
such information pertains, or otherwise became part of the public domain, after its disclosure to
the receiving Party through no fault of or breach of its obligations under this Section 15 by the
receiving Party;
(d) was disclosed to the receiving Party, other than under an obligation of confidentiality or
non-use, by a Third Party who had no obligation to the Party that Controls such information not to
disclose such information to others; or
(e) was independently discovered or developed by the receiving Party or its Affiliates, as
evidenced by their written records, without the use of, and by personnel who had no access to,
Confidential Information belonging to the Party that Controls such information.
15.3 Disclosure and Use Restriction. Except as expressly provided herein, the Parties agree
that, during the Term and for [***] thereafter, each Party and its Affiliates and sublicensees will
keep completely confidential and will not publish or otherwise disclose any Confidential
Information of the other Party, its Affiliates or sublicensees. Neither Party will use any
Confidential Information of the other Party without such other Party’s consent, except as expressly
permitted by this Agreement.
15.4 Authorized Disclosure. Each Party may use and disclose Confidential Information of the
other Party to the extent that such use and disclosure is:
(a) made in response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided, however, that such Party will
first have given notice to such other Party and given such other Party a reasonable opportunity to
quash such order and to obtain a protective order requiring that the Confidential Information and
documents that are the subject of such order be held in confidence by such court or governmental or
regulatory body or, if disclosed, be used only for the purposes for which the order was issued; and
provided, further, that if a disclosure order is not quashed or a protective order is not obtained,
the Confidential Information disclosed in response to such court or governmental order will be
limited to that information which is legally required to be disclosed in response to such court or
governmental order;
(b) otherwise required by law, rule or regulation; provided, however, that the disclosing
Party will provide such other Party with notice of such disclosure in advance thereof to the extent
practicable;
(c) made by such Party to the regulatory authorities as required in connection with any filing
of XXXx, 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;
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(d) made by such Party, in connection with the performance of this Agreement, to Affiliates,
permitted sublicensees, research partners, employees, consultants, representatives or agents, each
of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least
equivalent in scope to those set forth in this Section 15;
(e) made by such Party to existing or potential acquirers or merger candidates; existing or
potential pharmaceutical collaborators (to the extent contemplated under this Agreement);
investment bankers; existing or potential investors, venture capital firms or other financial
institutions or investors for purposes of obtaining financing; or Affiliates, each of whom prior to
disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope
to those set forth in this Section 15; provided, however, neither Party will disclose any item of
the other Party’s Confidential Information to any existing or potential acquirer or merger partner
that is substantially involved in the development or Commercialization of pharmaceutical products
comprising or containing Single Chain Antibodies or Collaboration Products without first providing
such other Party with reasonable advance written notice of each such disclosure; or
(f) made in a patent application filed in conformance with this Agreement.
15.5 Terms of Agreement to be Maintained in Confidence. Subject to the provisions of this
Section 15, 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.
16. Public Communications
16.1 General Provisions. The Parties will cooperate with respect to the timing and content of
communications with the public regarding the development and marketing of Collaboration Products,
under the terms to be set forth in each Development Plan and subject to the provisions of this
Section 16.
16.2 Use of Name. Neither Party will make public use of the other Party’s name except (a) in
connection with announcements and other permitted disclosures relating to this Agreement and the
activities contemplated hereby, (b) as required by applicable law, rule, or regulation, and (c)
otherwise as agreed in writing by such other Party.
16.3 Press Releases.
16.3.1 If the Parties desire to make a joint press release regarding the execution of this
Agreement, the final form of such release will be subject to approval of both Parties prior to its
release to the public. For subsequent press releases and other written public disclosures relating
to this Agreement or the Parties’ relationship hereunder (each, a “Proposed Disclosure”), each
Party will use reasonable efforts to submit to the other Party a draft of such Proposed Disclosure
for review and comment by the other Party at least [***] days prior to the date on which such Party
plans to release such Proposed Disclosure, and in any event will submit such drafts at least [***]
prior to the release of such Proposed Disclosure, and will review and consider in good faith any
comments provided in response.
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16.3.2 If a Party is unable to comply with the foregoing [***] notice requirement because of a
legal obligation or stock exchange requirement to make more rapid disclosure, such Party will not
be in breach of this Agreement but will in that case give telephone notice to a senior executive of
the other Party and provide a draft disclosure with as much notice as possible prior to the release
of such Proposed Disclosure.
16.3.3 A Party may publicly disclose without regard to the preceding requirements of this
Section 16.3 information that was previously disclosed in a Proposed Disclosure that was in
compliance with such requirements.
16.4 Publications. At least [***] prior to submission of any material related to the research
or development activities hereunder for publication or presentation, 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.
No publication or presentation with respect to the research or development activities hereunder
will be made unless and until the other Party’s comments on the proposed publication or
presentation have been duly considered and any information determined by the other Party to be its
Confidential Information has been removed. 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.
17. Term and Termination
17.1 Term. The term of this Agreement (the “Term”) will commence on the Effective Date and
will expire upon the earlier of (i) the date of expiration of all royalty and payment obligations
due under this Agreement for all Collaboration Products, and (ii) fifty years from the Effective
Date, unless earlier terminated as provided in this Agreement.
17.2 Breach.
17.2.1 In the event that MedImmune materially breaches a material obligation under this
Agreement, Micromet will have the right to send written notice to MedImmune that Micromet will
terminate the licenses granted to MedImmune under this Agreement in the entirety or, as set forth
in Section 9.2.2, with respect to a particular Collaboration Product in a particular country of the
Territory, unless such breach is cured within [***] ([***] for a payment breach) after receipt by
MedImmune of such notice. If such breach is not cured within the applicable period and if for a
breach other than a payment breach, MedImmune does not submit the issue of breach to arbitration
under Section 22.4, then, upon expiration of the applicable period, the licenses granted to
MedImmune under this Agreement will terminate in the entirety or with respect to the applicable
Collaboration Product in the applicable country of the Territory and MedImmune will have no further
obligations under this Agreement except those set forth in Section 18. In the event that MedImmune
disputes a payment obligation for which Micromet provides notice under this Section 17.2.1 and
MedImmune notifies Micromet of such dispute and makes the payment under protest, then
notwithstanding such payment, MedImmune will have the right to arbitrate under Section 22.4 whether
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MedImmune is obligated to make such payment and Micromet will return such disputed payments to
MedImmune to the extent MedImmune prevails in such arbitration.
17.2.2 In the event that Micromet materially breaches a material obligation under this
Agreement, MedImmune will have the right to send written notice to Micromet that MedImmune will
terminate the licenses and co-promotion rights granted to Micromet under this Agreement in the
entirety or, as set forth in Section 9.2.4, with respect to a particular Collaboration Product in a
particular country of the Territory unless such breach is cured within [***] ([***] for a payment
breach) after receipt by Micromet of such notice. If such breach is not cured within the
applicable period and if, for a breach other than a payment breach, Micromet does not submit the
issue of breach to arbitration under Section 22.4, then, upon expiration of the applicable period,
the licenses and co-promotion rights granted to Micromet under this Agreement will terminate in the
entirety or with respect to the applicable Collaboration Product in the applicable country of the
Territory and Micromet will have no further obligations under this Agreement except those set forth
in Section 18. In the event that Micromet disputes a payment obligation for which MedImmune
provides notice under this Section 17.2.2 and Micromet notifies MedImmune of such dispute and makes
the payment under protest, then notwithstanding such payment, Micromet will have the right to
arbitrate under Section 22.4 whether or not Micromet is obligated to make such payment and to the
extent Micromet prevails in such arbitration, MedImmune will return such disputed payments to
Micromet to the extent that Micromet prevails in such arbitration.
17.3 Voluntary Termination. MedImmune will have the right to terminate the licenses granted
to MedImmune under this Agreement in the entirety or in one or more countries of the Territory by
[***] prior written notice to Micromet. If the licenses granted to MedImmune are terminated in the
entirety pursuant to this Section 17.3, then MedImmune will have no further obligations under this
Agreement except for those set forth in Section 18. If the licenses granted to MedImmune are
terminated in one or more countries pursuant to this Section 17.3, then MedImmune will have no
further payment obligations with respect to such countries.
18. Effects of Termination
18.1 Continuation of Development and Commercialization.
18.1.1 Upon termination in the entirety of MedImmune’s licenses under this Agreement pursuant
to Sections 17.2.1 or 17.3, and subject to any rights retained by MedImmune’s sublicensees in the
Territory pursuant to Section 18.8, Micromet will have the right to continue the development of and
to Commercialize, by itself or with or through Third Parties: (a) on a worldwide basis, any
Collaboration Product that binds to a Non-Proprietary Target, and (b) for use and sale in Europe
only, any Approved Collaboration Product binding to a Proprietary Target with respect to which
Micromet has exercised a Co-Promotion Option and has made the contribution to development costs set
forth in Section 5.3. Micromet may exercise the continuation right described in this Section
18.1.1 by providing MedImmune with a Continuation Notice in accordance with the terms of Section
6.1.2.
18.1.2 Upon continuation of development or Commercialization of a Collaboration Product by
Micromet pursuant to Sections 6.1 and 18.1.1, MedImmune will, upon request of Micromet:
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(a) continue the Development Activities set forth in the applicable Development Plan relating
to clinical trials commenced by or on behalf of MedImmune prior to the effective date of such
continuation, at the cost and expense of Micromet, or upon request of Micromet and subject to
Applicable Law and to MedImmune’s obligations to Third Parties conducting such Development
Activities, transfer such Development Activities to Micromet;
(b) transfer to Micromet or its designee the then-existing clinical scale manufacturing
process for such Collaboration Product or the existing Commercial Process for such Collaboration
Product, under the terms set forth in Section 8;
(c) provide Micromet with Clinical Trial Materials for such Collaboration Product (if, at the
time of such continuation, MedImmune is providing Micromet with Clinical Trial Materials) until
such time as Micromet or its designee has established and validated a manufacturing process for any
such Collaboration Product and is approved to manufacture Pivotal Trial and commercial supplies of
Collaboration Product (but in no event longer than [***] from completion of the transfer of the
manufacturing process described in Section 8); and
(d) transfer to Micromet all non-clinical and clinical data, information, regulatory
approvals, and Know-How directly related to such Collaboration Product, and any trademarks relating
to such Collaboration Product.
18.1.3 In consideration of the performance of the obligations set forth in the preceding
Section 18.1.2, Micromet will pay MedImmune:
(a) in the event of voluntary termination by MedImmune, a technology transfer fee equal to the
amount of any reasonable and documented expenses at the FTE Rate as well as any out-of-pocket
expenses incurred by MedImmune in the course of effecting the transfer of materials described in
Section 18.1.2(b);
(b) [***] for Clinical Trial Materials provided under Section 18.1.2(c), on the terms set
forth in Section 7;
(c) if, at the time of such termination, MedImmune is supplying Micromet with Collaboration
Product, for commercial supply of Collaboration Product, under the terms set forth in the
applicable Commercial Supply Agreement executed by the Parties pursuant to Section 7.11.1 or, if no
such agreement has been executed, under the terms set forth in Section 7;
(d) the royalty set forth in Section 7.11.2(b), and the payments of Section 10.5.3; and
(e) the royalty set forth in Section 6.1.3, unless Micromet has terminated in the entirety
MedImmune’s licenses under this Agreement pursuant to Section 17.2.1, in which case no such royalty
is due.
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18.1.4 If the licenses granted to Micromet under this Agreement are terminated in the entirety
pursuant to Section 17.2.2, then MedImmune will have the right to continue the development of and
to Commercialize Collaboration Products by itself or with or through Third Parties in the
Territory. Upon such termination, (a) Micromet will, at MedImmune’s option, either continue or
terminate the activities set forth in each Research Plan commenced prior to the effective date of
such termination, and, if any Research Plan is terminated, transfer to MedImmune at [***] expense
the BiTE Molecules generated pursuant to such Research Plan and associated data, and (b) MedImmune
will provide Micromet with Clinical Trial Materials (if, at the time of such termination, MedImmune
is supplying Micromet with Clinical Trial Materials) required by Micromet to complete any clinical
trials commenced by or on behalf of Micromet prior to the effective date of such termination
pursuant to a Development Plan approved unanimously by the JDC.
18.2 Effect of Expiration on Intellectual Property. Upon expiration of this Agreement
pursuant to Section 17.1 above, (a) the licenses granted in Section 11 by Micromet to MedImmune
will become fully paid, perpetual, and irrevocable, and (b) the licenses granted in Section 11 by
MedImmune to Micromet will become fully paid, perpetual, and irrevocable.
18.3 Effects of Termination on Licenses.
18.3.1 If the licenses granted to MedImmune under this Agreement are terminated in the
entirety pursuant to Section 17.2.1 or Section 17.3, then the licenses granted to Micromet by
MedImmune under this Agreement will continue in full force and effect under the terms and
conditions of this Agreement, except that (a) with respect to any Collaboration Product binding to
a Non-Proprietary Target, the licenses granted to Micromet under Section 11 will be extended to
include the Territory and (b) with respect to any Collaboration Product binding to a Proprietary
Target, the licenses granted to Micromet under Section 11 will be extended to include the
development, manufacture, sale and use of such Collaboration Product in Europe; provided, however,
that Micromet’s and MedImmune’s obligations under this Agreement with respect to such licenses and
any Patents and Know-How covered thereunder will also remain in full force and effect; and
provided, further, that in each case such licenses to Micromet will be subject to any rights
retained by MedImmune’s sublicensees in the Territory pursuant to Section 18.8.
18.3.2 If the licenses granted to MedImmune under this Agreement are terminated in one or more
countries in the Territory pursuant to Section 17.2.1 or 17.3, then (a) with respect to any
Collaboration Product binding to a Non-Proprietary Target, the licenses granted to Micromet under
Section 11 will be extended to each such country, and (b) with respect to any Collaboration Product
binding to a Proprietary Target, the licenses granted to Micromet under Section 11 will be extended
to each such country that is in Europe; provided, however, that Micromet’s and MedImmune’s
obligations under this Agreement with respect to such licenses and any Patents and Know-How covered
thereunder will also remain in full force and effect; and provided, further, that in each case such
licenses to Micromet will be subject to any rights retained by MedImmune’s sublicensees in the
Territory pursuant to Section 18.8.
18.3.3 In the event that the rights and licenses granted to Micromet under this Agreement are
terminated under this Agreement, then the rights and licenses granted to MedImmune under this
Agreement will remain in full force and effect under this Agreement, and Micromet’s and MedImmune’s
obligations
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with respect to such licenses and any Patents and Know-How covered thereunder will remain in
full force and effect.
18.4 Accrued Rights. Termination of this Agreement in the entirety for any reason or
termination of the rights and licenses granted to a Party under this Agreement will be without
prejudice to any rights that will have accrued to the benefit of a Party prior to the effective
date of such termination. Such termination will not relieve a Party from obligations that are
expressly indicated to survive the termination of this Agreement or termination of the rights and
licenses granted to a Party thereunder.
18.5 Survival. Sections 10.1, 10.2, 10.3, 10.4, 11.1.2, 11.2.6, 12.1.1, 12.1.2, 12.1.3, 14,
15, 16.2, 18, 19, 21 and 22 (except for Section 22.2.2), and the limitation on remedies set forth
in Sections 4.5.2, 9.2.2 and 9.2.4, together with any definitions used or exhibits referenced
therein, will survive any termination or expiration of this Agreement. In addition, the provisions
set forth in Sections 6.1, 7 and 8 will survive any termination or expiration of this Agreement to
the extent such provisions are necessary to effect the activities described in this Section 18.
18.6 Inventory. During a period of [***] following any termination of this Agreement,
MedImmune will be entitled, at its option, to sell any completed inventory of Collaboration Product
which remains on hand as of the date of the termination under the licenses granted under this
Agreement, so long as MedImmune pays to Micromet the royalties applicable to said subsequent sales
in accordance with the same terms and conditions as set forth in this Agreement.
18.7 Proprietary Target Restrictions. Upon termination of this Agreement in its entirety for
any reason or termination of MedImmune’s rights with respect to a Collaboration Product against a
Proprietary Target, Micromet agrees not to and agrees not to assist a Third Party to research,
develop, market or sell any Collaboration Product against a Proprietary Target in any country,
other than in countries in Europe as to which Micromet has rights to a Collaboration Product
against a Proprietary Target under the provisions of this Agreement.
18.8 Sublicenses. In the event that a Party’s licenses under this Agreement are terminated
with respect to one or more countries, and a sublicense has been granted under this Agreement under
any such licenses by such Party with respect to Collaboration Product in any such country, then
this Agreement will become an agreement between the Party whose licenses were not terminated and
any such sublicensee with respect to Collaboration Products in any such country, subject to such
sublicensee agreeing to be bound to the terms and conditions of this Agreement; provided, however,
that this Section 18.8 will not apply with respect to any sublicensee that is in breach of the
applicable sublicense agreement or would be in breach of this Agreement upon the conversion of the
applicable sublicense as contemplated herein; and provided, further, that MedImmune’s obligations
to supply Clinical Trial Materials and Licensed Product for commercial sale may not be transferred
by MedImmune to any sublicensee pursuant to this Section 18.8.
19. Indemnification and Insurance
19.1 Indemnification of Micromet. MedImmune will indemnify Micromet and its Affiliates, and
their respective directors, officers, and employees (each, a “Micromet Indemnitee”), and defend and
save each of them harmless from and against any and all losses, damages, liabilities, costs and
expenses
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(including reasonable attorneys’ fees and expenses) in connection with any and all liability
suits, investigations, claims or demands (collectively, “Losses”) arising from or occurring as a
result of any claim or lawsuit by a Third Party against a Micromet Indemnitee, to the extent caused
by or arising out of: (a) the gross negligence or willful misconduct on the part of MedImmune, its
Affiliates or sublicensees in performing any activity contemplated by this Agreement, or (b) the
development or Commercialization of Collaboration Product by MedImmune, its Affiliates or
sublicensees (other than Collaboration Product provided by MedImmune to Micromet or its Affiliates
or their licensees); in each case, excluding any Losses for which Micromet has an obligation to
indemnify one or more MedImmune Indemnitees pursuant to Section 19.2.
19.2 Indemnification of MedImmune. Micromet will indemnify MedImmune, its Affiliates, and
their respective directors, officers, and employees (each, a “MedImmune Indemnitee”), and defend
and save each of them harmless from and against any and all Losses arising from or occurring as a
result of any claim or lawsuit by a Third Party against a MedImmune Indemnitee, to the extent
caused by or arising out of: (a) the gross negligence or willful misconduct on the part of Micromet
or its Affiliates, licensees or sublicensees in performing any activity contemplated by this
Agreement, or (b) the research, development or Commercialization of Collaboration Product (or any
other product or process as to which Micromet is licensed under this Agreement by MedImmune) by
Micromet, its Affiliates or licensees; in each case, excluding any Losses for which MedImmune has
an obligation to indemnify one or more Micromet Indemnitees pursuant to Section 19.1.
19.3 Notice of Claim. All indemnification claims in respect of any MedImmune Indemnitee or
Micromet Indemnitee seeking indemnity under Sections 19.1 or 19.2 (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 19.1 or Section 19.2,
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). The Indemnified Party will furnish promptly to the Indemnifying Party copies
of all papers and official documents received in respect of any Losses.
19.4 Control of Defense. At its option, the Indemnifying Party may assume the defense of any
claim subject to indemnification as provided for in Sections 19.1 and 19.2 (each, a “Third Party
Claim”) by giving written notice to the Indemnified Party within 30 days after the Indemnifying
Party’s receipt of an Indemnification Claim Notice. Upon assuming the defense of a Third Party
Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim
any legal counsel selected by the Indemnifying Party. In the event the Indemnifying Party assumes
the defense of a Third Party Claim, the Indemnified Party will immediately deliver to the
Indemnifying Party all original notices and documents (including court papers) received by any
Indemnitee in connection with the Third Party Claim. Should the Indemnifying Party assume the
defense of a Third Party Claim, the Indemnifying Party will not be liable to the Indemnified Party
or any other Indemnitee for any legal expenses subsequently incurred by such Indemnified Party or
other Indemnitee in connection with the analysis, defense or settlement of the Third Party Claim.
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19.5 Right to Participate in Defense. Without limiting Section 19.4, 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 (i) the employment thereof has been specifically authorized by the
Indemnifying Party in writing, or (ii) the Indemnifying Party has failed to assume the defense and
employ counsel in accordance with Section 19.4 (in which case the Indemnified Party will control
the defense).
19.6 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 other than by the payment of money damages, and as to which the Indemnifying Party
will have acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the
Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any
settlement or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its sole
discretion, will deem appropriate, and will transfer to the Indemnified Party all amounts which
said Indemnified Party will be liable to pay prior to the entry of judgment. With respect to all
other Losses in connection with Third Party Claims, where the Indemnifying Party has assumed the
defense of the Third Party Claim in accordance with Section 19.4, 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 will not
be liable for any settlement or other disposition of a Loss by an Indemnitee that is reached
without the written consent of the Indemnifying Party. Regardless of whether the Indemnifying
Party chooses to defend or prosecute any Third Party Claim, no Indemnitee will admit any liability
with respect to, or settle, compromise or discharge, any Third Party Claim without the prior
written consent of the Indemnifying Party.
19.7 Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party will, and will cause each other Indemnitee to,
cooperate in the defense or prosecution thereof and will furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings,
trials and appeals as may be reasonably requested in connection with such Third Party Claim. Such
cooperation will include access during normal business hours afforded to the Indemnifying Party to,
and reasonable retention by the Indemnified Party of, records and information that are reasonably
relevant to such Third Party Claim, and making Indemnitees and other employees and agents available
on a mutually convenient basis to provide additional information and explanation of any material
provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its
reasonable and documented out-of-pocket expenses in connection with such cooperation.
19.8 Insurance. During the Term, each Party will have and maintain such types and amounts of
liability insurance as is normal and customary in the industry generally for parties similarly
situated, and will upon request provide the other Party with a copy of its certificate of insurance
in that regard, along with any amendments and revisions thereto.
20. Representations and Warranties
20.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other Party that, as of the Effective Date:
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20.1.1 Such Party (a) has the power and authority to enter into this Agreement and perform its
obligations hereunder, and (b) has taken all necessary action on its part required to authorize the
execution and delivery of this Agreement and the performance of its obligations hereunder;
20.1.2 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 and general principles of equity, whether enforceability is
considered a proceeding at law or equity;
20.1.3 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 applicable law or 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.
20.2 Additional Representations and Warranties of Micromet. Micromet hereby represents and
warrants to MedImmune that:
(a) 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;
(b) Micromet owns all right, title and interest in and to the Patents of Exhibit A-1;
(c) The Patents of Exhibit A-2 are licensed to Micromet under one or more Technology
Acquisition Agreements of Exhibit D and that the Patents of Exhibit A-2 have been sublicensed to
MedImmune in the Territory under this Agreement;
(d) Micromet has not previously granted and, prior to expiration or termination of this
Agreement, will not grant any rights in the Licensed Technology that conflict with the rights and
licenses granted to MedImmune herein;
(e) prior to the Effective Date, it has disclosed to MedImmune all such information that, to
Micromet’s knowledge, is material to the activities contemplated hereunder and that, to Micromet’s
knowledge, such information and data is correct in all material respects;
(f) as of the Effective Date, it has neither received from nor delivered any written claim to
a Third Party (nor has a Third Party to the knowledge of Micromet’s officers threatened such a
claim) asserting the invalidity, unenforceability or misuse of any Patent included in Licensed
Technology;
(g) to the knowledge of Micromet’s officers as of the Effective Date, other than Patents
licensed to MedImmune under this Agreement, no Patent owned or controlled by a Third Party would be
infringed by manufacture, use or sale of a BiTE Product in the Territory; and
(h) as of the Effective Date, (i) all the Technology Acquisition Agreements as to which
Micromet is a party with respect to Know-How and Patents that relate to BiTE Product or
47
manufacture or use thereof are listed in Exhibit D, (ii) such Technology Acquisition
Agreements are in full force and effect and that valid and effective sublicenses thereunder have
been granted to MedImmune pursuant to this Agreement, (iii) to the knowledge of Micromet, no Party
to any such Technology Acquisition Agreement is in breach thereof, and (iv) to the knowledge of
Micromet, no Party to any such Technology Acquisition Agreement has notified any other party
thereto of any breach thereof.
20.3 Schedule of Exceptions. Promptly after a Target is designated a Collaboration Target
pursuant to this Agreement, Micromet will deliver to MedImmune written notice that Micromet
continues to grant the warranties set forth in Section 20.2 above with respect to such
Collaboration Target and Collaboration Products binding thereto; provided, however, that if
Micromet cannot, in good faith, make one or more of such warranties with respect to such
Collaboration Target and Collaboration Products binding thereto, Micromet may include in such
written notice a schedule of exceptions describing which such warranties are no longer valid and
the reasons therefor.
20.4 Additional Representations and Warranties of MedImmune. MedImmune hereby represents and
warrants to Micromet that MedImmune is a corporation duly organized, validly existing and in good
standing under the laws of Delaware, 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. Promptly after a
Proprietary Target is designated a Collaboration Target, MedImmune will warrant to Micromet at such
time that (a) MedImmune owns or is the exclusive licensee of the Patents or patent applications
responsible for the proprietary status of such Target, and (b) to the best knowledge of MedImmune’s
officers, the performance of Micromet’s rights and obligations under this Agreement with respect to
the development of Collaboration Products binding to such Proprietary Target does not infringe any
Patents of a Third Party other than those licensed to MedImmune, provided, however, if MedImmune
cannot in good faith make the warranty (b) of this Section 20.4, MedImmune shall designate such
exceptions to Micromet in writing.
21. Disclaimer; Limitation of Liability
21.1 Disclaimer of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT,
MEDIMMUNE AND MICROMET MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER
IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND MEDIMMUNE AND MICROMET EACH
SPECIFICALLY DISCLAIM ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR IMPLIED,
INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR
ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES.
21.2 Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR LOST PROFITS, LOSS
OF DATA, OR FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER
CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF THIS
AGREEMENT. THE FOREGOING LIMITATIONS WILL NOT APPLY TO AN AWARD OF ENHANCED DAMAGES AVAILABLE
UNDER THE PATENT LAWS FOR WILLFUL PATENT
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INFRINGEMENT AND WILL NOT LIMIT EITHER PARTY’S LIABILITY AND OBLIGATIONS TO THE OTHER PARTY
UNDER SECTIONS 15 AND 19.
22. Miscellaneous
22.1 Force Majeure. Neither Party will be held liable or responsible to the other Party or be
deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or
performing any term of this Agreement when such failure or delay is caused by or results from
events beyond the reasonable control of the non-performing Party, including fires, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of God
or acts, omissions or delays in acting by any governmental authority. The non-performing Party
will notify the other Party of such force majeure within 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.
22.2 Assignment.
22.2.1 Neither Party will sell, transfer, assign, delegate, pledge or otherwise dispose of,
whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its
rights or duties under this Agreement without the prior written consent of the other Party, which
consent will not be withheld or delayed unreasonably; provided, however, that either Party may
assign or transfer this Agreement or any of its rights or obligations under this Agreement without
the consent of the other Party (a) to any Affiliate of such Party, or (b) to any Third Party with
which it merges or consolidates, or to which it transfers all or substantially all of its assets to
which this Agreement relates. The assigning Party (unless it is not the surviving entity) will
remain jointly and severally liable with the relevant Affiliate or Third Party assignee under this
Agreement, and the relevant Affiliate assignee, Third Party assignee or surviving entity will
assume in writing all of the assigning Party’s obligations under this Agreement. Any purported
assignment or transfer in violation of this section will be void ab initio and of no force or
effect.
22.2.2 Neither Party will assign or otherwise transfer ownership (in whole or in part), in the
case of Micromet, in and to Licensed Technology and, in the case of MedImmune, in and to MedImmune
Collaboration Technology and/or MedImmune Independent Technology (as to MedImmune, in each case
only with respect to (i) Approved Collaboration Products against a Non-Exclusive Target in Europe,
(ii) Approved Collaboration Product against a Proprietary Target in Europe to the extent that
Micromet has co-promotion rights thereto under this Agreement, and (iii) any Commercial Process for
producing the foregoing in Europe) without the prior written consent of the other Party; provided,
however, that a Party may assign such interest in whole without such consent (a) to an Affiliate of
such Party, (b) in connection with the transfer or sale of all or substantially all of its
business, or (c) to any Third Party with which it merges or consolidates; and provided, further,
that such assignment is in connection with a permitted assignment of this Agreement and to the same
assignee as to which this Agreement is assigned, that such
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assignment is subject to this Agreement, and that the assignee assumes in writing the
assigning Party’s obligations under this Agreement.
22.3 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.
22.4 Governing Law; Dispute Resolution.
22.4.1 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
the State of New York, U.S.A., without giving effect to any principles of choice of law that would
require the application of the laws of a different state or country.
22.4.2 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 may notify the other Party in
writing of such Dispute. If the Parties are unable to resolve the Dispute within [***] of receipt
of the written notice by the other Party, such dispute will be referred to the Chief Executive
Officers of each of the Parties who will use their good faith efforts to resolve the Dispute within
[***] after such referral.
22.4.3 If a Dispute is not resolved as provided in the preceding Section 22.4.2, whether
before or after termination of this Agreement, the Parties hereby agree to resolve such Dispute by
final and binding arbitration administered under the rules of arbitration of JAMS by one arbitrator
appointed in accordance with the said Rules, provided that upon request of either Party, three
arbitrators will be appointed. If the Parties are unable to mutually select such panel, the panel
will be selected in accordance with the procedures of JAMS. The decision and award rendered by the
panel will be final and binding. In any such arbitration, the arbitrators will not have the right
to modify the terms and conditions of this Agreement. As a result, the rights and obligations of
the Parties will be determined in accordance with the terms and conditions of this Agreement and
any award will be only in accordance with the terms and conditions of this Agreement. The Parties
will exert best efforts to have the decision and award rendered within [***] after the first to
occur of (i) notice of breach of this Agreement, which breach is a subject of the arbitration, and
(ii) a notice invoking this arbitration provision. Judgment upon the award may be entered in any
court having jurisdiction thereof. Any arbitration pursuant to this section will be held in
Washington, D.C. or such other place as may be mutually agreed upon in writing by the Parties. With
respect to any disputes arising in connection with an alleged breach of a Party’s rights and
obligations with respect to confidential Know-How or Confidential Information received from the
other Party, the arbitrator will apply
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
50
the discovery provisions of the Federal Rules of Civil Procedure. This means that depositions
may be taken and full discovery may be obtained in any arbitration commenced under this Section
22.4 with respect to such disputes.
22.4.4 Notwithstanding the provisions of this Section 22.4, either Party will have the right
to seek temporary or permanent injunctive relief in any court of competent jurisdiction as may be
available to such Party under the laws and rules applicable in such jurisdiction. Further, the
provisions of this Section 22.4 will not apply with respect to any claim of a Party that the other
Party is infringing any of its patents.
22.5 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 MedImmune, to:
Before January 1, 2004
MedImmune, Inc.
00 X. Xxxxxxx Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
XXX
Attention: Legal Department
Facsimile: (000) 000-0000
00 X. Xxxxxxx Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
XXX
Attention: Legal Department
Facsimile: (000) 000-0000
After January 1, 2004
MedImmune, Inc.
Xxx XxxXxxxxx Xxx
Xxxxxxxxxxxx, XX 00000
XXX
Attention: Legal Department
Facsimile: (000) 000-0000
Xxx XxxXxxxxx Xxx
Xxxxxxxxxxxx, XX 00000
XXX
Attention: Legal Department
Facsimile: (000) 000-0000
If to Micromet, to:
Micromet AG
Xxxxxxxxxxxxxxxxx 0
00000 Xxxxxx
Xxxxxxx
Attention: Chief Business Officer
Facsimile: xx00 00 000 000 000
Xxxxxxxxxxxxxxxxx 0
00000 Xxxxxx
Xxxxxxx
Attention: Chief Business Officer
Facsimile: xx00 00 000 000 000
with a copy to:
Cooley Xxxxxxx XXX
Xxx Xxxxxxx Xxxxxx
00
Xxxxxx Xxxx Center
00000 Xxxxxxx Xxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxx Xxxxx
Facsimile: (000) 000-0000
00000 Xxxxxxx Xxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxx Xxxxx
Facsimile: (000) 000-0000
or to such other address as the Party to whom notice is to be given may have furnished to the other
Party in writing in accordance with this Agreement. Any such communication will be deemed to have
been given (i) when delivered, if personally delivered or sent by facsimile on a business day, and
(ii) on the second business day after dispatch, if sent by internationally-recognized overnight
courier. It is understood and agreed that this Section 22.5 is not intended to govern the
day-to-day business communications necessary between the Parties in performing their duties, in due
course, under the terms of this Agreement.
22.6 Entire Agreement; Modifications. This Agreement (including any Exhibits, Schedules, or
other attachments hereto, each of which is hereby incorporated by reference herein) sets forth and
constitutes the entire agreement and understanding between the Parties with respect to the subject
matter of this Agreement and all prior agreements, understanding, promises and representations,
whether written or oral, with respect thereto are superseded by this Agreement, including the
Confidentiality Agreement between the Parties dated December 11, 2002; provided, however, that no
agreement between the Parties executed contemporaneously with this Agreement will be so superseded
by this Agreement. Each Party confirms that it is not relying on any representations or warranties
of the other Party except as specifically set forth in this Agreement. No amendment or
modification of this Agreement will be binding upon the Parties unless in writing and duly executed
by authorized representatives of both Parties.
22.7 Relationship of the Parties. It is expressly agreed that the relationship between the
Parties is and will be that of independent contractors, and that the relationship between the
Parties will not constitute a partnership, joint venture or agency. Neither Party will have the
authority to make any statements, representations or commitments of any kind, or to take any
action, which will be binding on the other, without the prior written consent of the other to do
so. All persons employed by a Party will be employees of such Party and not of the other Party and
all costs and obligations incurred by reason of any such employment will be for the account and
expense of such Party.
22.8 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.
22.9 Counterparts. This Agreement may be executed in counterparts, each of which will be
deemed an original, but all of which together will constitute one and the same instrument.
22.10 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.
52
22.11 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.
22.12 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.
22.13 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 “Sections” are references to the numbered sections
of this Agreement, unless expressly stated otherwise.
[Remainder of this page is left blank intentionally]
53
In Witness Whereof, the Parties hereto have caused this Agreement to be executed by their
duly authorized representatives as of the date first above written.
Micromet AG
|
MedImmune, Inc. |
|
By: /s/ Xxxxxxxxx Xxxx
|
By: /s/ Xxxxx X. Xxxx | |
Name: Xxxxxxxxx Xxxx
|
Name: Xxxxx X. Xxxx | |
Title: Chief Business Officer
|
Title: CEO | |
By: /s/ X.X. Xxxxx |
||
Name: X.X. Xxxxx |
||
Title: Chief Financial Officer |
[Signature Page to the BiTE Research Collaboration Agreement]
54
Exhibit A-1
Issued Patents and Published Patent Applications of Micromet
(as of the Effective Date)
(as of the Effective Date)
Patent / Application | ||||||
Country | Title of Application | Number | Comment/Status | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1
Patent / Application | ||||||
Country | Title of Application | Number | Comment/Status | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
[***]
|
[***] | [***] | [***] | |||
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
2
Exhibit A-2
Issued Patents and Published Patent Applications
licensed by Micromet
(as of the Effective Date)
licensed by Micromet
(as of the Effective Date)
Application | Application | Patent | Date of | |||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1
Application | Application | Patent | Date of | |||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
2
Date of | ||||||||||||
Application | Application | Application | Patent | Patent | ||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
3
Date of | ||||||||||||
Application | Application | Application | Patent | Patent | ||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
Licensed by Micromet from [***]
As per [***]
I. Patents and Patent Applications based on Swiss Patent Application No[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
4
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] |
II. Patents and Patent Applications based on Swiss Patent Application [***]
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. | |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
5
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
Patents and patent applications licensed to Micromet by [***]include, in addition to those rights
indicated above, the patents and patent applications based on Swiss Patent Application No.[***] and
any and all patents that may issue from said patent applications, including any and all divisions,
continuations, continuations-in-part, extensions in any form whatsoever, substitutions, renewals,
registrations, revalidations, reissues or additions of or to any of the aforesaid patents and
patent applications.
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
6
Exhibit B
Net Profits
“Net Profits” means Net Sales and damages awarded to MedImmune for [***] [***] for the applicable
countries of Europe, less: (a) [***], (b) [***], (c) [***], (d) [***], (e) [***], and (f) [***],
(g) [***] all as further defined below, and (h) [***] in Europe, including [***]; (i) a charge for
[***] and [***] at [***]; (j) all [***] including the [***], [***] and [***] in excess of [***] or
[***] [***], if any; and (k) all [***] of [***] or [***] with respect to Collaboration Product in
Europe and [***] paid by [***] resulting therefrom.
“[***]” means, with respect to a particular unit of the Collaboration Product, (a) the [***] (if
[***]), or (b) the [***] to a Third Party [***], and any costs of [***], [***], [***] and [***] of
product (if necessary), [***], and [***] by [***] (to the extent not included in such purchase
price).
“[***]” means the costs and expenses specifically identifiable to the [***], consisting of [***],
[***] about sales to [***] and other [***], [***], [***], [***], [***] and [***] and other such
activities, but in any case, not including any costs or expenses which are [***] by any Third
Party.
“[***]” means, with respect to the Collaboration Product before and after launch, the direct costs
and expenses of [***], [***], [***], [***], [***], [***], relationships with opinion leaders and
[***], [***] of a Collaboration Product), [***], [***] required to maintain or expand [***] of the
Collaboration Product and other similar activities related to such product, obtaining [***], and
[***] (to the extent not included in the [***]); all of which costs will be calculated based on
both [***] (e.g., [***], [***], [***] and [***], [***] and [***] and [***] to the marketing of
Collaboration Product in Europe, etc.) and costs of outside services and expenses (e.g., [***],
[***], [***], etc.) in each case consistent with MedImmune’s normal accounting practice applied
consistently across all MedImmune’s products.
“[***]” means, with respect to a Collaboration Product, [***] incurred by [***] for the [***],
[***] and [***] such [***] and specifically identifiable to the [***] for such product, including
cost of [***], [***], [***], [***], [***], training, and [***], overhead for the [***] and
allocated to the [***] in Europe and [***] and [***] allocated to the [***] for [***] in Europe in
each case consistent with MedImmune’s normal accounting practice applied consistently across all
MedImmune’s products.
“[***]” means, with respect to the Product, costs equal to [***]% of the sum of the [***], [***]
and [***] related to the Product.
“[***]” means the cost and expense for [***] of Collaboration Product in any county of Europe
required or requested by [***] thereover or as a result of a [***], including but not limited to,
expenses incurred for [***].
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1
“[***]” means payments due as a result of the [***] of Collaboration Products.
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
2
Exhibit C
List of Proprietary Targets
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1
Exhibit D
List of Technology Acquisition Agreements
• [***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1
Exhibit E
[***] Patent
Country | Appln.-No. | Patent-No. | Expiry Date | Status | Type | |||||
[***]
|
[***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1
Exhibit F
List of Excluded Targets
• [***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1