exv10w42



 





Exhibit 10.42




***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2




COLLABORATION AND LICENSE AGREEMENT




     This Collaboration and License Agreement (the “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 Staffelseestrasse 2, 81477, Munich, Germany (“Micromet”), and MedImmune, Inc.,
having its principal place of business at 35 W. Watkins Mill Road, Gaithersburg, MD 20878
(“MedImmune”). Micromet and MedImmune each may be referred to herein individually as a “Party,” or
collectively as the “Parties.”



Recitals




     A. Micromet is developing MT103 (as defined below).



     B. MedImmune is a biotechnology company with experience in the development and
commercialization of pharmaceutical products.



     C. Micromet and MedImmune desire to collaborate on the development of Licensed Products to
obtain marketing approval of such products for various indications in the countries of North
America, and thereafter to have MedImmune commercialize Licensed Product in these countries.



     D. Micromet and MedImmune desire to have MedImmune develop a commercial scale manufacturing
process for Licensed Products developed under this Agreement, and thereafter to have MedImmune
produce Licensed Product for the Parties.



     E. Micromet
desires to have MedImmune grant a loan in the amount of €10,000,000 secured by
a note convertible into Micromet preferred stock, and MedImmune desires to make such loan.



     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 the Agreement.



     1.1 “Affiliate” means a legal entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with a Party. For purposes
of this definition only, “control” and, with correlative meanings, the terms “controlled by” and
“under common control with” means (a) the possession, directly or indirectly, of the power to
direct the management or policies of a legal entity, whether through the ownership of voting



 









 







securities or by contract relating to voting rights or corporate governance, or (b) the
ownership, directly or indirectly, of more than 50% of the voting securities or other ownership
interest of a legal entity; provided, however, that if local law restricts foreign ownership,
control will be established by direct or indirect ownership of the maximum ownership percentage
that may, under such local law, be owned by foreign interests.



     1.2 “Applicable Law” means the laws, rules, and regulations, including any statutes, rules,
regulations, or other requirements, that may be in effect from time to time and that apply to the
development, manufacture, registration, and marketing of Licensed Product in the United States and
the European Union and its member states, including any such statutes, rules, regulations, or other
requirements of the FDA and the EMEA. If MedImmune is manufacturing Licensed 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 Licensed Product in Japan.



     1.3 “BiTE Molecule” means a polypeptide comprising a bi-specific Single Chain Antibody binding
to T-cells.



     1.4 “BiTE Product” means any composition or formulation containing a BiTE Molecule.



     1.5 “BLA” means a Biologics License Application filed with the FDA in conformance with
applicable laws and regulations.



     1.6 “cGMP” means current Good Manufacturing Practices as contained in 21 CFR Parts 210 and 211
as amended from time to time, and the equivalent Applicable Laws in jurisdictions outside the
United States.



     1.7 “Clinical Trial Materials” means Licensed Product formulated in accordance with applicable
specifications, and placebo of such formulations, for administration to patients in clinical
trials.



     1.8 “Collaboration Technology” means Joint Collaboration Technology, MedImmune Collaboration
Technology and Micromet Collaboration Technology.



     1.9 “Commercial Process” means a commercial scale manufacturing process for a Licensed Product
that is compliant with all Applicable Laws.



     1.10 “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.



     1.11 “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



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of pharmaceutical products of similar market potential and market size, at a similar stage in
the product life cycle, taking into account the risk of development or Commercialization of the
product, the cost-effectiveness of efforts or resources, the competitiveness of alternative
products that are or are expected to be in the marketplace, the scope and duration of patent rights
or other proprietary rights related to the product, the profitability of the product and
alternative products and other relevant commercial factors.



     1.12 “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.



     1.13 “Development Activities” means any activities to be performed in connection with the
development of Licensed 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 MAAs.



     1.14 “Development Cost” means the aggregate amount of costs incurred by Micromet in
development of MT103, including Commercial Process development and regulatory filing costs, as
determined in a reasonable manner consistent with Micromet’s normal internal cost accounting
practices and in accordance with generally accepted accounting principles, consisting of: (i)
[***], (ii) [***], (iii) [***] including [***] and [***], [***], and [***] and [***], (iv) [***].



     1.15 “Development Plan” means the development plan for a Licensed Product, as approved
pursuant to Section 2 and as may be amended pursuant to the terms of this Agreement.



     1.16 “EMEA” means the European Medicines Evaluation Agency and any successor agency thereof.



     1.17 “FDA” means the United States Food and Drug Administration and any successor agency
thereof.



     1.18 “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 [***] Costs. Scientific or technical work includes
performing research, experimental laboratory work, developing manufacturing processes for Licensed
Product, conducting pre-clinical and clinical development of Licensed Product, recording and
writing up results, reviewing literature and references, holding scientific discussions, and
attending conferences in the relevant field.





 




			
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     1.19 “FTE Rate” means US$[***], for [***], and #eu#[***] for [***], which amount includes, for
each FTE, [***] [***] and [***] (excluding items provided for separately in the Development Plan),
[***], [***], [***], and a [***] plus [***].



     1.20 “Fully-Burdened Manufacturing Cost” means the consolidated fully burdened cost incurred
by MedImmune in the manufacture of Licensed Product, consisting of: (i) [***]; (ii) [***]; (iii)
[***] of [***] and [***], excluding any [***] or [***]; (iv) a charge for [***] and [***] of [***]
and [***]; (v) [***] and [***]; (vi) a charge for [***] for [***] and [***]and [***]and [***]and
[***]and [***]; and (vii) charges for [***] or [***]; and (viii) [***] that are paid to [***] with
respect to [***]; in each of the above cases to the extent reasonably allocable to the manufacture
of Licensed 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 Licensed 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
Licensed Product or any component thereof, excluding any process development amortization costs
paid to such Third Party as a result of such Third Party performing development work on a
Commercial Process for MedImmune, will be added to the aggregate amount of the foregoing items (i)
through (viii).



     1.21 “IND” means an Investigational New Drug Application filed with the FDA.



     1.22 “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 a Licensed 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.



     1.23 “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 Licensed 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 Licensed 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 Licensed Product or the manufacture or
use thereof or compounds or compositions used or employed in the manufacture or use of a Licensed
Product. Independent Micromet Technology includes the Patents listed in Exhibits A-1, A-2 and A-3.



     1.24 “JDC” has the meaning set forth in Section 2.1.1.





 




			
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     1.25 “Joint Collaboration Technology” means any Patents and Know-How made or generated jointly
by employees, or Third Party agents or independent contractors of both Parties or their Affiliates
during the course of, in furtherance of, and as a direct result of such employees, agents or
independent contractors performing an activity pursuant to this Agreement.



     1.26 “JPT” has the meaning set forth in Section 2.2.1.



     1.27 “JPT Leader” has the meaning set forth in Section 2.2.1.



     1.28 “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.



     1.29 “Lead Product” means MT103 or any Replacement Product selected by the JDC pursuant to
Section 3.5 as a successor to the then-current Lead Product.



     1.30 “Lead Product Process” means a Commercial Process for the Lead Product.



     1.31 “Licensed Product” means MT103 and any Replacement Product, in each case, alone or as
part of a composition or formulation.



     1.32 “Licensed Technology” means the Independent Micromet Technology, the Micromet
Collaboration Technology, and Micromet’s rights and interest in Joint Collaboration Technology.



     1.33 “MAA” means a marketing approval application filed with the EMEA, and any corresponding
applications in countries or territories other than the European Union and other than the United
States.



     1.34 “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.



     1.35 “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.



     1.36 “MedImmune Process Technology” means any Patents and Know-How 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, in each case that is useful for the
manufacture of a Licensed Product.



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     1.37 “Micromet Collaboration Technology” means any Patents and Know-How, made or generated
solely by employees, or 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.



     1.38 “MT103” means the BiTE Product containing the BiTE Molecule with the amino acid sequence
set forth in Exhibit B.



     1.39 “MT103 Patents” means (a) patent applications [***] entered as national phases of [***];
and (b) any related Patents.



     1.40 “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 Licensed Product, less: (a) trade, quantity and cash discounts allowed; (b) commissions,
discounts, refunds, rebates (including federal, state or local government rebates), chargebacks,
retroactive price adjustments, all to the extent allowed; (c) refunds or credits for actual returns
of a Licensed Product; (d) any tax imposed on the production, sale, delivery or use of a Licensed
Product, including, 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 Licensed Product between a Party and its
Affiliates or their sublicensees who have the right to Commercialize a Licensed Product.



     1.41 “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.



     1.42 “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.



     1.43 “Replacement Product” means any BiTE Molecule, other than MT103, that binds to [***],
alone or as part of a composition or formulation.



     1.44 “Research Plan” has the meaning set forth in Section 3.5.3.



     1.45 “Royalty Term” has the meaning set forth in Section 10.4.2.





 




			
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     1.46 “Single Chain Antibody” means a single chain polypeptide having a binding affinity for a
cell surface antigen, 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.



     1.47 “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 Licensed 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 Licensed Product. The Technology Acquisition
Agreements of Micromet that exist as of the Effective Date are listed in Exhibit C.



     1.48 “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 Licensed Product.



     1.49 “Territory” means the United States of America, Canada, and Mexico, and any territories
or possessions of the foregoing countries.



     1.50 “Third Party” means any entity other than Micromet, MedImmune or their respective
Affiliates.



     1.51 “Upstream Licensor” means Micromet’s licensor of the [***] Patent.



     1.52 “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.



     1.53 “[***] Patent” means the patent listed in Exhibit D.



2. Collaboration Governance 




2.1 Joint Development Committee.




     2.1.1 Establishment of the JDC. The Parties will establish a joint development committee (the
“JDC”), which will oversee the development of Licensed Products under this Agreement. Each Party
will appoint two employees to serve as their 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 2,
the JDC will establish its own procedural rules for its operation.





 




			
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          2.1.2 Tasks of the JDC. The JDC will: (a) determine indications to be pursued in the
development of each Licensed Product in addition to the indications set forth in the applicable
Development Plan; (b) review and approve any updates or amendments to each Research Plan and
Development Plan proposed by the JPT; (c) review the product lifecycle plans of the Parties for
Licensed Products, including indication and label expansions, new dosage forms, and new
formulations or delivery systems; and (d) take such other actions as are expressly delegated to the
JDC in this Agreement.




          2.1.3 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 12) to attend any meeting of the JDC. Each meeting
of the JDC will include at least one representative from each Party.




          2.1.4 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.




          2.1.5 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 of the Parties who will use good faith efforts to
resolve such matter. If such officers fail to resolve such matter, then: (a) if such matter is
primarily related to the development of Licensed Product in the Territory or the development of a
Commercial Process, the Chief Executive Officer of [***] will finally decide the issue; and (b) if
such matter is primarily related to the development of Licensed Product outside the Territory, the
Chief Executive Officer of [***] will finally decide the issue.



               (c) Notwithstanding the provisions in this Section 2.1.5 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 20.4.





 




			
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               (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 Licensed Product .



     2.2 Joint Project Team.



          2.2.1 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 discretion, create sub-teams of the JPT for the purpose of carrying out
specific tasks provided for in a Development Plan.




          2.2.2 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.




          2.2.3 Development Plan. The initial Development Plan for MT103 is attached as Exhibit E. The
JPT will prepare and update each Development Plan for approval by the JDC from time to time, but in
any case at least semi-annually.




          2.2.4 Reporting. Within 30 days 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 each Development Plan 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. Development of Licensed Products




     3.1 Technology Transfer.



          3.1.1 As further specified in the applicable Development Plan, Micromet will transfer to
MedImmune: (a) the manufacturing process for MT103 as it exists on the Effective Date in [***]
scale, including the analytical methods relating to MT103; and (b) certain material information
relating to MT103, including preclinical and clinical analytical assays, preclinical and clinical
data, and copies of any regulatory filings. MedImmune will reimburse Micromet for any reasonable
and documented out-of-pocket expenses (including payments made to Micromet’s consultants and
independent contractors) incurred by Micromet to a Third Party in connection with the technology
transfer described in this Section 3.1.1 to the extent that Micromet is requested by MedImmune in
writing to incur such expenses.




          3.1.2 During the Term on a periodic basis, Micromet will transfer to MedImmune Know-How that
is Licensed Technology known to Micromet and that is useful with






 




			
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respect to the research, development, or production of a Licensed Product or Commercial
Process being developed by MedImmune pursuant to a Development Plan. Micromet will effect the
above technology transfer in accordance with procedures agreed upon by the JDC. MedImmune will
reimburse Micromet for any reasonable and documented out-of-pocket expenses (including payments
made to Micromet’s consultants and independent contractors) incurred by Micromet to a Third Party
in connection with the technology transfer described in this Section 3.1.2 to the extent that
Micromet is requested by MedImmune in writing to incur such expenses.




          3.1.3 For the avoidance of doubt, Micromet will not have any obligation under this Agreement
to disclose or transfer any Know-How relating to the 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 development
of a Licensed Product under a Development Plan or Research Plan.




          3.1.4 During the Term on a periodic basis, MedImmune will transfer to Micromet Know-How that
is MedImmune Collaboration Technology or Joint Collaboration Technology known to MedImmune and that
is useful with respect to the research, development, or production of a Licensed Product being
developed by Micromet pursuant to a Development Plan. MedImmune will effect the above technology
transfer in accordance with procedures agreed upon by the JDC. Micromet will reimburse MedImmune
for any reasonable and documented out-of-pocket expenses (including payments made to MedImmune’s
consultants and independent contractors) incurred by MedImmune to a Third Party in connection with
the technology transfer described in this Section 3.1.4 to the extent that MedImmune is requested
by Micromet in writing to incur such expenses.




     3.2 Clinical Development Responsibilities; Development Costs.



          3.2.1 Responsibilities of MedImmune. As set forth in greater detail in each Development Plan,
MedImmune will have the responsibility for (a) performing any Development Activities necessary to
enable the filing of a BLA and, if applicable, the MAAs in the indications set forth in such
Development Plan in the Territory, and (b) filing and prosecuting such BLA and, if applicable, MAAs
through the grant of Marketing Approval for Licensed Products in the Territory. MedImmune will not
conduct any clinical trial for Licensed Products outside the Territory without Micromet’s express
prior written consent.




          3.2.2 Responsibilities of Micromet. As set forth in greater detail in each Development Plan,
Micromet or its designees may perform in its discretion and at its own cost any Development
Activities in addition to those performed by MedImmune pursuant to Section 3.2.1 above as may be
necessary to obtain Marketing Approval for Licensed Product in the European Union or any other
countries or territories outside the Territory. Micromet will not conduct any clinical trial for
Licensed Product in the Territory without MedImmune’s express prior written consent, or as
otherwise expressly permitted under this Agreement.




          3.2.3 Approval of Clinical Trials. Each Party will submit to the JDC the details of each
proposed clinical study conducted for Licensed Product at least 60 days prior to the proposed
initiation date of such study. Neither Party will initiate any clinical trial for

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Licensed Product without the JDC’s express prior written authorization, which authorization
will not be withheld unreasonably or delayed unreasonably.




          3.2.4 Development Costs.




               (a) With respect to the costs and expenses incurred by [***] in the performance of Development
Activities relating to any [***] and [***] that are ongoing as of the Effective Date and that are
necessary to support [***] for [***] (as determined by the JDC), [***] will bear [***]% of such
costs and expenses incurred after the Effective Date for any such Development Activities pursuant
to the Development Plan for MT103.



               (b) [***] will bear [***]% of the costs and expenses of any [***] that are necessary to
support [***] for [***] (as determined by the JDC) and that are initiated after the Effective Date
pursuant to the Development Plan for MT103.



               (c) With respect to the costs and expenses incurred by [***] after the Effective Date, but
prior to [***] for [***], in the performance of Development Activities relating to any clinical
studies for MT103, [***] will bear [***]% of such costs and expenses up to a maximum reimbursement
of US$[***]; provided, however, that any amounts paid to [***] under this Section 3.2.4(c) will be
[***] upon [***] of an [***] for a Licensed Product in the Territory.



               (d) After the [***] for a Licensed Product, [***] will bear any costs incurred by [***] in
connection with its performance of Development Activities provided for in the applicable
Development Plan; provided, however, that any costs and expenses incurred by the Parties in
connection with a clinical trial for Licensed Product that, pursuant to a Development Plan, is
conducted jointly by both Parties will be shared by the Parties as follows: [***]% by MedImmune and
[***]% by Micromet.



               (e) Each Party will make any payments due to the other Party under this Section 3.2.4 [***]
based on an invoice and supporting documentation submitted by such other Party.



          3.2.5 Progress Reports and Exchange of Information.




               (a) The Parties will continuously inform each other of their Development Activities through
their interactions in the JPT and through progress reports submitted to the JDC. Upon request of a
Party, the other Party will provide the requesting Party copies of clinical trial protocols,
preliminary reports and final reports of any clinical studies performed by it, and any other
information or data reasonably requested by the other Party.



               (b) Each Party hereby grants to the other Party (the “Passive Party”) the right to use and
reference any non-clinical and clinical data (including raw data, safety data, and efficacy data),
clinical trial protocols, INDs, BLAs, MAAs and other regulatory filings, any Marketing Approvals
for Licensed Product, and any correspondence with any regulatory





 




			
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authorities relating to any Licensed Product, generated, developed or received by or on behalf
of the granting Party in the course of the performance of this Agreement, in each case, for the
development of Licensed Product and the filing and prosecution of any INDs, BLAs, and MAAs, and the
maintenance of any Marketing Approvals and other regulatory approvals of Licensed Product by the
Passive Party in the Territory (if MedImmune is the Passive Party) or outside the Territory (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 Licensed Product, then such Party will notify the Passive Party of such
meeting or visit and such Passive Party will have the right to have two representatives of such
Passive Party present at such meeting or visit, provided that such representatives remain silent
observers 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
3.2.5(b).




               (c) Prior to the compilation of a final report for any clinical trial performed pursuant to
any Development Plan, the Party conducting such clinical trial will provide the Passive Party with
any data (including raw data, safety data, and efficacy data) resulting from such trial. The
Passive Party may review such data and make recommendations to the other Party regarding such data
(including, by way of example, the accuracy, presentation, or interpretation thereof). The Party
compiling the final report will reasonably consider and incorporate the comments provided by a
Passive Party under this Section 3.2.5(c).



          3.2.6 Diligence in the United States.




               (a) MedImmune, itself or through one or more Third Parties, will use its Commercially
Reasonable Efforts to develop the Lead Product for approval and sale in the United States, and to
develop the Lead Product Process. All efforts of MedImmune’s Affiliates and sublicensees, together
with any efforts of Micromet performed under a Development Plan (to the extent applicable to
MedImmune’s development efforts for the United States), will be considered efforts of MedImmune for
the purpose of determining MedImmune’s compliance with its obligations under this Section 3.2.6.



               (b) MedImmune will be deemed to have met its obligations under Section 3.2.6(a) with respect
to the Lead Product during such time as MedImmune is performing the Development Activities with
respect to the development of the Lead Product and Lead Product Process for approval and sale in
the United States set forth in the initial Development Plan for such Lead Product, as may be
amended by unanimous consent of the JDC.



               (c) MedImmune will be deemed to have met its obligations under Section 3.2.6(a):



12









 





                    (i) for [***], if MedImmune has spent US$[***] in such year on Development Activities with
respect to the development of the Lead Product and Lead Product Process;



                    (ii) for each of [***], if MedImmune has spent US$[***] during each such calendar year on
Development Activities with respect to the development of the Lead Product and Lead Product
Process;



                    (iii) for each [***], if MedImmune has spent US$[***] in such calendar year on Development
Activities with respect to the development of the Lead Product and Lead Product Process;



                    (iv) even if MedImmune has not met its minimum spending obligations set forth in subsections
(i) through (iii) above in a particular calendar year:



                         (1) if [***] it has spent US$[***] in [***] on Development Activities with respect to the
development of the Lead Product and Lead Product Process;



                         (2) if [***] it has spent US$[***] in [***] on Development Activities with respect to the
development of the Lead Product and Lead Product Process;



                         (3) if [***] it has spent US$[***] in [***] on Development Activities with respect to the
development of the Lead Product and Lead Product Process;



                         (4) if at the [***] year thereafter up to the calendar year of the first Marketing Approval
for the Lead Product in the US, it has spent US$[***] in [***] and the [***] on Development
Activities with respect to the development of the Lead Product and Lead Product Process.



               (d) If Micromet determines that MedImmune has failed to meet its obligations under Section
3.2.6(a) with respect to the Lead Product and, in addition, MedImmune is not deemed to have met
such obligations pursuant to Section 3.2.6(b) or 3.2.6(c), then, as the sole and exclusive remedy
for such failure, Micromet will have the right to terminate in the entirety the licenses granted to
MedImmune under this Agreement pursuant to Section 15.2.1.



          3.2.7 Diligence in [***].




               (a) After a Licensed Product receives Marketing Approval in [***], MedImmune will submit to
the JDC a Development Plan for developing such Licensed Product for sale in [***]. Following
approval of such Development Plan by the JDC pursuant to Section 2.1.2 above, MedImmune will use
its Commercially Reasonable Efforts to perform the Development Activities set forth in each such
Development Plan and to file for Marketing





 




			
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Approval with respect to such Licensed Product in [***]. All efforts of MedImmune’s Affiliates
and sublicensees will be considered efforts of MedImmune for the purpose of determining MedImmune’s
compliance with its obligations under this Section 3.2.7. If MedImmune fails to submit such a plan
for [***] or, if such a plan is submitted and approved, and MedImmune fails to undertake such
activities and file for Marketing Approval as provided in the preceding sentence, then, as its sole
and exclusive remedy for such failure, Micromet may terminate MedImmune’s licenses as provided in
Section 15.2 with respect to each such country with respect to which a plan is not submitted or not
executed, as applicable.




               (b) Notwithstanding Section 3.2.7(a) above, MedImmune may at any time after first commercial
sale of Licensed Product in [***] provide written notice to Micromet that Commercialization of
Licensed Product in either or both of [***] will have a material adverse effect on [***] that can
be generated with Licensed Product [***]. Any such notice will include copies of marketing studies
and other materials on which MedImmune’s conclusion of such adverse effects are based. Promptly
after receipt of such notice and materials from MedImmune, the Parties will meet to discuss
MedImmune’s conclusion.



               (c) If the Parties agree that MedImmune should not [***], then MedImmune will be under no
obligation under this Agreement to develop, obtain Marketing Approval for, or sell Licensed Product
[***]. MedImmune will provide Micromet with an annual update, in writing, on the reasons for
continuing the delay of the launch of such Licensed Product [***].



               (d) If Micromet disagrees with MedImmune’s initial assessment or any annual update thereof
that the sale of Licensed Product [***] will have a material adverse effect on [***] that can be
generated with such Licensed Product [***], Micromet will have the right to submit such dispute to
arbitration in accordance with the provisions of Section 20.4. Micromet will not have the right to
terminate MedImmune’s license [***] until there is a determination in an arbitration proceeding
pursuant to Section 20.4 that the sale of Licensed Product [***], as the case may be, will not
adversely affect [***] in the Territory as a whole.



     3.3 Process Development.



          3.3.1 Performance of Development Plan.




               (a) As set forth in greater detail in the applicable Development Plan, MedImmune will develop
the Lead Product Process. MedImmune will use the manufacturing process transferred to it by
Micromet pursuant to Section 3.1 as the basis for the Lead Product Process. MedImmune will bear
all costs and expenses associated with the development of the Lead Product Process.



               (b) Micromet will assist MedImmune in the development of each Commercial Process being
developed by MedImmune through Micromet’s participation in the JPT and by providing any other
assistance reasonably requested by MedImmune. MedImmune will reimburse Micromet for any reasonable
and documented out-of-pocket expenses and, based





 




			
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on the FTE Rate, for any FTEs performing Development Activities relating to a Commercial
Process, but only to the extent requested by MedImmune. MedImmune will make any such payments to
Micromet quarterly in arrears based on an invoice and supporting documentation submitted by
Micromet.




          3.3.2 Progress Reports; Access. During the development of each Commercial Process being
developed by MedImmune, MedImmune will keep Micromet informed through the JPT of MedImmune’s
process development activities and progress on an on-going basis. Further, MedImmune will provide
to Micromet, on a regular basis, any assay data, validation data, standard operating procedures,
reagents and any other materials or protocols, in each case only as necessary for conducting any
release assays relating to the detection, identification, and characterization of Licensed Product,
that MedImmune has generated or used during the development of each such Commercial Process.




          3.3.3 Third Party Intellectual Property. Each Party will advise the other Party of Patents
owned by a Third Party that are known to a Party and that may present an infringement risk with
respect to Licensed Product or any Commercial Process that is being developed by MedImmune.




          3.3.4 Exchange of CMC Documentation. Upon completion of development of each Commercial
Process, MedImmune will provide to Micromet, or at the discretion of MedImmune to the applicable
regulatory agency, all necessary CMC documentation in the possession of MedImmune, its Affiliates
or contractors and, as reasonably requested by Micromet, assistance with the presentation of such
documentation to regulatory authorities outside the Territory, all as required for filing of an MAA
relating to the manufacture of the applicable Licensed Product by means of such Commercial Process
and Micromet will reimburse MedImmune at the FTE Rate for such assistance.




          3.3.5 Processes for other Licensed Products. Micromet understands and agrees that MedImmune
is not obligated to develop a Commercial Process for any Licensed Product other than the Lead
Product, except as set forth in Section 3.5.2. However, if MedImmune develops such a Commercial
Process, Micromet will have the rights and obligations set forth in this Section 3.3 (excluding
Section 3.3.1(a)) with respect to such Commercial Process.




     3.4 Restrictions on Development and Commercialization of Licensed Products.



          3.4.1 During the Term, Micromet will not itself or through any Third Party (whether through
the grant of a license or otherwise) develop or Commercialize in the Territory any Licensed
Product, 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 a Licensed Product outside the Territory.




          3.4.2 During the period commencing on the Effective Date and ending on the earlier of (a) the
[***], and (b) any [***] executed by the Parties on the Effective Date (the






 




			
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“[***]”), 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 the BiTE Agreement or a Licensed Product under this Agreement.




     3.5 Development of Replacement Products.



          3.5.1 Commencement. Subject to the terms and conditions of this Agreement, MedImmune may
elect to commence development of a Replacement Product, as a follow-on product to the Lead Product,
contemporaneously with the development or Commercialization of the Lead Product, or as a substitute
for the then-current Lead Product. If MedImmune intends to commence development of a Replacement
Product, then MedImmune will provide Micromet with written notice of such intention. Each such
notice will identify the cell surface antigen of the proposed Replacement Product (i.e. [***]) and
the desired specifications of the BiTE Molecule for the proposed Replacement Product.




          3.5.2 Substitution of Lead Product. If MedImmune elects to develop a Replacement Product as a
substitute for the then-current Lead Product, such Replacement Product will be deemed the new Lead
Product upon approval of a Research Plan for such product by the JDC, and MedImmune may discontinue
development of the replaced Lead Product; provided, however, that if MT103 is replaced in this way,
MedImmune will continue with the development of the Commercial Process for MT103 under the terms of
this Agreement for so long as Micromet is continuing development of MT103 outside the Territory.




          3.5.3 Research Plan. Promptly after submission of an antigen for a proposed Replacement
Product pursuant to Section 3.5.1, the JPT will prepare a plan for the construction of BiTE
Molecules binding to such antigen, and the pre-clinical development of Replacement 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. 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 submit each Research Plan to the JDC for approval.
Promptly after the JDC approves a Research Plan developed by the JPT, the JPT will meet to prepare
a Development Plan for the applicable Replacement Product, as set forth in Section 2.2.2 of this
Agreement. The JPT will update each Research Plan for approval by the JDC from time to time, but
in any case at least semi-annually.




          3.5.4 Creation and Selection of BiTE Molecules. No later than [***] after the approval of
each Research Plan by the JDC, Micromet will commence with the construction of BiTE Molecules, and
will create 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 a Replacement Product






 




			
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for further development under the terms and conditions set forth in this Section 3. Micromet
will not be obligated to initiate work under more than one Research Plan during any [***] period.




          3.5.5 Research and Development Costs.




               (a) If MedImmune elects to develop a Replacement Product (i) as a substitute for the
then-current Lead Product and Micromet is continuing development of a Licensed Product outside the
Territory, or (ii) contemporaneously with the development or Commercialization of the Lead Product,
then this Section 3.5.5(a) will govern the allocation of costs incurred by the Parties in
connection with the performance of the Research Plan for such Replacement Product. MedImmune will
bear the costs and expenses incurred by MedImmune in the performance of activities under such
Research Plan. MedImmune will reimburse Micromet for any costs and expenses incurred by Micromet
in the performance of any activities provided for in such Research Plan. 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 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. MedImmune will pay any
costs and expenses incurred by Micromet in the performance of any activities provided for in the
Research Plan [***] within [***] after receipt of a corresponding invoice from Micromet that
estimates the costs and expenses for such quarter. Micromet will provide quarterly reports on its
activities under such 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 to
Micromet under this Section 3.5.5(a). 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 [***] days after receipt of
such report. In any event, Sections 3.2.4(d) and (e) will govern the allocation of costs incurred
by the Parties in connection with any Development Activities for Replacement Products.



               (b) If MedImmune elects to develop a Replacement Product as a substitute for the then-current
Lead Product and Micromet (i) has discontinued development of Licensed Product outside the
Territory, and (ii) elects to participate in such development, then this Section 3.5.5(b) will
govern the allocation of costs incurred by the Parties in connection with the performance of the
Research Plan for such Replacement Product. The Parties will share the costs and expenses incurred
by the Parties in the performance of activities under such Research Plan as follows: [***]% by
MedImmune and [***]% by Micromet; provided, however, that if Micromet discontinues development of
MT103 during the performance of a Research Plan for a





 




			
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new Lead Product, Micromet will only be obligated to share the costs and expenses incurred by
the Parties after the date of such discontinuation. Each Party’s 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 a Party will be charged at [***]. In no event will a
Party be obligated to make any payments to the other Party 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 a Party 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. Each Party will provide quarterly
reports on its activities under such Research Plan and the costs and expenses for such activities
and the Parties will make any payments due under this Section 3.5.5(b) in arrears based on such
quarterly reports. In any event, Sections 3.2.4(d) and (e) will govern the allocation of costs
incurred by the Parties in connection with any Development Activities for Replacement Products. If
Micromet does not elect to participate in the development of a Replacement Product under this
Section 3.5.5(b), then Micromet will not itself or through any Third Party (through a license or
otherwise) develop or Commercialize such Replacement Product outside the Territory, except pursuant
to Section 3.5.5(d).




               (c) If Micromet has constructed a BiTE Molecule as a Replacement Product and selected such
BiTE Molecule for further development in a pre-clinical development program, and such selection is
contemporaneous with the development or Commercialization of the Lead Product under this Agreement,
then Micromet will provide MedImmune with written notice of such selection.



                    (i) If MedImmune elects to participate in the development of such Replacement Product and
MedImmune informs Micromet in writing of such election within [***] after receipt by MedImmune of
Micromet’s notice of selection, then (a) the provisions of Section 3.5.5(b) will govern the
allocation of costs incurred by the Parties in connection with the performance of the Research Plan
for such Replacement Product, and (b) Sections 3.2.4(d) and (e) will govern the allocation of
further costs.



                    (ii) If MedImmune does not elect to participate in the development of such Replacement Product
within such [***] period, or if MedImmune informs Micromet that it declines to participate in such
development, then (a) notwithstanding anything in this Agreement, MedImmune will not itself or
through any Third Party (through a license or otherwise) develop or Commercialize such Replacement
Product inside the Territory, except pursuant to Section 3.5.5(d), (b) Micromet may continue
development of such product [***], (c) MedImmune will have no obligations whatsoever with respect
to the development or Commercialization of such product, and (d) during the Term, Micromet will not
develop or Commercialize such product in the Territory.





 




			
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                    (d) If a Party that has not elected to participate in the development of a Replacement Product
pursuant to Section 3.5.5(b) (in the case of Micromet) or Section 3.5.5(c)(ii) (in the case of
MedImmune), and such Party desires to commence such participation, such Party may provide written
notice of such desire to the other Party at any time. Upon receipt of such notice, the Parties
will meet to discuss and negotiate in good faith the commercial terms upon which the
non-participating Party will commence such participation.



          3.5.6 Discontinuation. MedImmune will have the right to terminate research with respect to
Replacement Products and the activities under a Research Plan with respect thereto by 3 months
prior written notice to Micromet, and after the expiration of such 3-month period, MedImmune will
no longer be obligated for costs and expenses incurred by Micromet with respect to such Replacement
Products. 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.




     3.6 Consequences of Substitution of MT103.



          3.6.1 If MedImmune elects to discontinue development of MT103 and develop a Replacement
Product as the new Lead Product, and if Micromet obtains Marketing Approval for MT103 in Europe
prior to the [***], Micromet will have the right, notwithstanding anything in this Agreement to the
contrary (including, without limitation, MedImmune’s exclusive right to market Licensed Products in
the Territory), to develop MT103, file a BLA and MAAs, and obtain Marketing Approval for MT103 in
the Territory.




          3.6.2 MedImmune will have the right to reacquire the license to Commercialize MT103 in the
Territory by providing written notice thereof to Micromet within [***] after receiving written
notice from Micromet that it has obtained Marketing Approval of MT103 in the US, and by paying with
such notice any milestone payments set forth in Section 10.2 that have not already been paid with
respect to a new Lead Product. Within [***] after exercising such right, MedImmune will pay to
Micromet [***]% of the amount corresponding to [***]% of any [***] with respect to MT103 after the
date that MedImmune has discontinued the development of MT103. MedImmune will pay the remaining
[***]% of such [***] either (a) as a lump sum payment on the first anniversary of the date on which
MedImmune has provided notice under this Section 3.6.2, or (b) in the form of a royalty of [***]%
on Net Sales of MT103 in the Territory by MedImmune, its Affiliates or their sublicensees in
addition to the royalties payable pursuant to Section 10.4.1; provided, however, that any remaining
amounts due to Micromet will bear interest of [***]% per annum compounded annually until the
payment has been made in full; and provided, further, that any amounts remaining unpaid will be due
and payable with the last royalty payment due for MT103 under this Agreement.




          3.6.3 If MedImmune does not provide any notice within the [***] period set forth in Section
3.6.1, or provides notice that it declines to exercise its right to reacquire the






 




			
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license to Commercialize MT103 in the Territory, Micromet will be free to Commercialize MT103
in the Territory alone or with or through a Third Party.




4. Supply of Licensed Product 




     4.1 Clinical Supply of Licensed Product. As provided in this Section 4, 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 clinical trials to be performed pursuant to each Development Plan.



     4.2 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 [***] for such Clinical Trial Materials. If
Micromet orders such Clinical Trial Material for use in Pivotal Trials, then MedImmune will
manufacture any such Clinical Trial Material 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 Clinical Trial Material as needed for the performance of clinical trials by Micromet in
accordance with the 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 Licensed
Product with its respective requirements of such Clinical Trial Materials at [***] for such
Clinical Trial Material, 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.



     4.3 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 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,





 




			
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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.




     4.4 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.



     4.5 Invoice and Payment. MedImmune will enclose an invoice with each shipment of Clinical
Trial Materials made pursuant to this Section 4 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 4, 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.



     4.6 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 4.3 above:
(a) will conform to the specifications for such Clinical Trial Materials set forth in the
Development Plan (the “Specifications”), and (b) will have been manufactured and shipped to
Micromet in accordance with cGMP and other Applicable Laws (the “Product Warranties”).



     4.7 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





 




			
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(including, but not limited to, quality control tests) relating to the production of the
Clinical Trial Materials in question or the Rejection Notice.




     4.8 Disputes Regarding Clinical Trial Materials.



          4.8.1 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 4.8.




          4.8.2 If the Clinical Trial Materials are alleged not to conform with the Product Warranties
set forth in Section 4.6(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.




          4.8.3 If the Clinical Trial Materials are alleged not to conform with the Product Warranties
set forth in Section 4.6(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 the Judicial Arbitration and
Mediation Services (“JAMS”), will determine whether the Clinical Trial Materials were
non-conforming with the Product Warranties set forth in Section 4.6(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.




     4.9 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 4.8,
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.



     4.10 Audits and Inspections.



          4.10.1 A delegation consisting of representatives of Micromet and its licensees that are to be
supplied Licensed Product 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


22









 







Commercial Process is implemented, and the documentation generated in connection with the
manufacture and testing of Licensed Product; 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 Licensed Product are manufactured fail to comply with
Applicable Law in such a manner as may affect the supply of Licensed Product hereunder. Such
inspections will take place during regular business hours 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.




          4.10.2 A representative of Micromet and its licensees that are to be supplied Licensed Product
by MedImmune under this Agreement will have the right to be present as a silent observer at any
announced visits to MedImmune by any regulatory authority relating to the manufacture of Licensed
Product. 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
Licensed Product. 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 4.10 in accordance with the provisions of Section 12 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.




     4.11 Commercial Supply of Licensed Product.



          4.11.1 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
Licensed Product in bulk form (i.e. filled vials, unlabelled and unpackaged) for use and sale
outside the Territory. If MedImmune elects to undertake the supply of Licensed Product to Micromet
or its licensees, then the Parties will enter into a supply agreement setting forth the terms and
conditions of the manufacture and supply (the “Commercial Supply Agreement”).




          4.11.2 Supply Price; Royalty.



               (a) Each Commercial Supply Agreement will provide that the supply price of Licensed Product
intended for commercial sale outside the Territory will be [***]% of the [***] so long as such
amount exceeds [***]% of [***] of Micromet or its licensees outside the Territory. 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 outside the Territory.





 




			
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been requested with respect to the omitted portions.




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               (b) If MedImmune has transferred a Commercial Process pursuant to Section 5 below and Micromet
obtains Licensed Product for commercial sale either by manufacturing Licensed Product itself or by
engaging a Third Party for the manufacture and supply of Licensed 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 Licensed Product by Micromet, its
Affiliates or licensees. At the time when the total royalty payments by Micromet to MedImmune
under this Section 4.11.2(b) equal [***], plus an interest charge of [***]% per annum on the unpaid
principal, the royalty rate will be adjusted as set forth in Exhibit F.



               (c) Notwithstanding the provisions of Section 4.11.2(b) above, Micromet will have no
obligation to pay royalties on Net Sales in Japan if the Commercial Process transferred to Micromet
by MedImmune, at the time of such transfer, is not compliant with Japanese cGMP and Applicable Law.



5. Transfer of Manufacturing Process




     5.1 Transfer Triggers. In accordance with Section 5.2 and upon 60 days advance written notice
to MedImmune, MedImmune will transfer to Micromet the then-current Commercial Process: (1) if
MedImmune does not desire to supply Licensed 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 5.1 until such time as it has completed the development of the applicable Commercial
Process. Except upon termination of all the licenses granted to MedImmune, Micromet cannot provide
notice under this Section 5.1 before MedImmune has completed the development of the applicable
Commercial Process if and for so long 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 5.1, 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 15.2.



     5.2 Manufacture During Process Transfer. During any transfer of Commercial Process made
pursuant to Section 5.1 above and until such time as Micromet or a contract manufacturer designated
by Micromet has established and validated such Commercial Process and is approved to manufacture
commercial supplies of the applicable Licensed Product (but in no event longer than [***] after the
applicable triggering event described in Section 5.1 above), MedImmune will continue to supply such
Licensed Product to Micromet at [***] for Clinical Trial Materials, and at the supply price set
forth in Section 4.11.2 pursuant to the Commercial





 




			
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Supply Agreement. Except as provided in this Section 5.2, upon receipt of the written notice
pursuant to Section 5.1, MedImmune will no longer have an obligation to manufacture such Licensed
Product for Micromet.




     5.3 Technology Transfer. As part of any Commercial Process transfer made pursuant to this
Section 5, 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 such Commercial 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, all necessary CMC documentation relating to
such cell culture media and nutrient feeds required for regulatory filings for the applicable
Licensed Product.



     5.4 Subsequent Process Transfer by Micromet. To the extent that Micromet has rights under
this Agreement to use a Commercial Process, Micromet will have the right to use a Third Party to
manufacture Licensed Product by means of a Commercial Process transferred to Micromet pursuant to
this Section 5 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. Except as provided in this Section 5.4, Micromet will not
transfer such Know-How to any Third Party.



6. Commercialization




     6.1 Principles of Commercialization. As between the Parties, MedImmune has the sole right to
Commercialize Licensed Product in the Territory during the Term, except as otherwise expressly set
forth in Section 3.6. As between the Parties, Micromet has the sole right to Commercialize
Licensed Product outside the Territory during the Term.



     6.2 Regulatory Obligations. MedImmune will be solely responsible for all activities in
connection with maintaining Marketing Approvals and other regulatory approvals for the marketing
and manufacture of Licensed Product in the Territory, including communicating and preparing and
filing all reports (including without limitation adverse drug experience reports) with the FDA.
Micromet will have the sole right to conduct activities in connection with maintaining Marketing
Approvals and other regulatory approvals for the manufacture of Licensed Product outside the
Territory, including communicating and preparing and filing all



25









 







reports (including without limitation adverse drug experience reports) with the applicable
regulatory authorities.



     6.3 Diligence.



          6.3.1 MedImmune will use Commercially Reasonable Efforts to Commercialize Licensed Product in
each country of the Territory in which MedImmune receives Marketing Approval therefor.




          6.3.2 If Micromet determines that MedImmune is not Commercializing Licensed Product as
required under Section 6.3.1 in a particular country in the Territory, then, as the sole and
exclusive remedy for such failure, Micromet will have the right to terminate all the licenses
granted to MedImmune under this Agreement with respect to such Licensed Product in such country
pursuant to Section 15.2.




     6.4 Adverse Drug Experiences. To the extent either Party receives any information regarding
adverse drug experiences related to the use of Licensed 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 Licensed 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.



     6.5 Branding, Trademarks, Trade Dress, and Logos.



          6.5.1 MedImmune will have sole responsibility for all trademarks, trade dress, logos, slogans,
and designs used on and in connection with Licensed Product 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 Licensed Product in the Territory.
MedImmune will select the trademark used to identify Licensed Product that will be sold in the
Territory pursuant to this Agreement. MedImmune will oversee the filing, prosecution and
maintenance of all trademark registrations for Licensed Product 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 Licensed Product in the Territory.




          6.5.2 Micromet will have sole responsibility for all trademarks, trade dress, logos, slogans,
and designs used on and in connection with Licensed Product outside the Territory. 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 marketing and sale of Licensed Product outside the
Territory. Micromet will select the trademark used to identify Licensed Product that will be sold
outside the Territory pursuant to this Agreement. Micromet will oversee the filing, prosecution
and maintenance of all trademark registrations for Licensed Product outside the Territory. Micromet
will be responsible for the payment of any and all costs relating to filing, prosecution, and
maintenance of the trademarks for Licensed Product outside the Territory.




26









 









	7.	 	Ownership of Intellectual Property; Acquisition of Third Party Intellectual Property





     7.1 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.



     7.2 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.



     7.3 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.



     7.4 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 7.



     7.5 Third Party Technology.



          7.5.1 Consent.




               (a) After the Effective Date, if a Party intends to negotiate a Technology Acquisition
Agreement that would be applicable to Licensed 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.



               (b) Subject to Section 7.5.1(c) below, 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.



27









 





               (c) Notwithstanding the provisions of Section 7.5.1(b), any Technology Acquisition Agreement
entered into by MedImmune with respect to any Commercial Process for a Lead Product will include
the right of MedImmune to grant Micromet a sublicense to MedImmune’s rights and licenses under such
Technology Acquisition Agreement.



               (d) 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.



          7.5.2 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 7.5.2 only apply
to Technology Acquisition Agreements that affect the Lead Product or the Lead Product Process.




          7.5.3 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 Licensed Product in the
Territory under its own Technology Acquisition Agreements and under any Technology Acquisition
Agreements of Micromet existing as of the Effective Date 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 10.4.3(b). Each such Technology Acquisition Payment under
a Micromet Technology Acquisition Agreement will be due and payable as set forth in the applicable
Technology Acquisition Agreement and shall 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 Licensed Product outside the Territory
under its own Technology Acquisition Agreements and under any Technology Acquisition Agreements of
MedImmune under which Micromet holds a license under this Agreement. Each such Technology
Acquisition Payment under a MedImmune



28









 







Technology Acquisition Agreement will be due and payable as set forth in the applicable
Technology Acquisition Agreement and shall be paid by Micromet to MedImmune.



               (c) Each Party has the right to notify the other Party that such Party terminates such Party’s
license under one or more of the other Party’s Technology Acquisition Agreements, in which case
such license will be terminated thereunder and the notifying Party will no longer be obligated to
make payments thereunder.



8. License Grants




     8.1 Licenses granted by Micromet.



          8.1.1 Subject to the terms and conditions set forth in this Agreement, Micromet hereby grants
to MedImmune an exclusive (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 Licensed Product
in the Territory for any use in humans.




          8.1.2 MedImmune hereby covenants and agrees not to use any confidential Know-How that is
Independent Micromet Technology or Micromet Collaboration 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 Licensed Product in
the Territory 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.




          8.1.3 MedImmune will have the right to grant sublicenses under the licenses granted in Section
8.1.1, 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, except that financial terms may be redacted.




     8.2 Licenses granted by MedImmune.



          8.2.1 Subject to the terms and conditions set forth in this Agreement and subject to the
payment obligations of Section 7.5.3, 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 outside the Territory Licensed Products developed by




29









 







MedImmune pursuant to any Development Plan for any use in humans. MedImmune understands and
agrees that, under the license set forth in this Section 8.2.1, Micromet may use, offer for sale,
sell, and import outside the Territory Licensed Product purchased from MedImmune hereunder for any
use in humans.




          8.2.2 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 Licensed 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 8.2.2 is exclusive except as to MedImmune and its
permitted licensees under Section 8.3 below.




          8.2.3 Upon transfer of a Commercial Process to Micromet in accordance with Sections 5.1 and
5.2 of this Agreement and subject to the payment obligations of Section 4.11.2 and Section 7.5.3,
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 8.2.5), royalty-bearing right and license, without the right to grant sublicenses, under
Independent MedImmune Technology, MedImmune’s rights and interest in the Joint Collaboration
Technology, and the MedImmune Collaboration Technology to use such Commercial Process to make and
have made the applicable Licensed Product for sale and use outside of the Territory.




          8.2.4 Upon transfer of a Commercial Process to Micromet in accordance with Section 5 of this
Agreement and subject to the payment obligations of Section 4.11.2 and Section 7.5.3, 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 8.2.5),
royalty-bearing right and license, without the right to grant sublicenses, under MedImmune Process
Technology to use such Commercial Process to make and have made the applicable Licensed Product for
sale and use outside of the Territory.




          8.2.5 In the event that Micromet grants a license outside the Territory to a Third Party for a
Licensed Product, and Micromet has a license under this Section 8.2 to the applicable Commercial
Process for such Licensed Product, then, upon request by Micromet, MedImmune will grant such Third
Party a license under Independent MedImmune Technology, MedImmune Process Technology, MedImmune’s
right and interest in the Joint Technology, and the MedImmune Collaboration Technology to use such
Commercial Process to make and have made the applicable Licensed Product for sale and use outside
of the Territory. The commercial terms of each such license will be the same as the terms set
forth in Sections 4.11.2 and 5, 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 5.




          8.2.6 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

30









 








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
(c) 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, except that financial terms may be redacted.




          8.2.7 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 Independent MedImmune Technology or MedImmune
Collaboration Technology, to develop or Commercialize any product other than Licensed 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.




          8.3 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 a BiTE Product(s) with such Third Party or with respect to Licensed
Product in the Territory. This limitation is not applicable to any BiTE Product as to which
MedImmune holds a license under this Agreement or under any other agreement with Micromet or its
Affiliates.




     8.4 Option for Exclusive License to [***] Patent.



          8.4.1 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 Licensed Products in the United States of America 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.




          8.4.2 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 10.4.3(b).




     8.5 Bankruptcy Provision under German Law.





 




			
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          8.5.1 In the event that Micromet becomes insolvent, has to file for insolvency or is
adjudicated insolvent, Micromet, its legal successor or the insolvency administrator shall, to the
extent legally possible, use its 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 shall continue to use the
licensing rights in accordance with the terms set out in this Agreement.




          8.5.2 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 shall, to the extent legally possible, use its 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 shall 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 to MedImmune.
Alternatively, Micromet or its legal successor or the insolvency administrator shall 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.




     8.6 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 8.6 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).



     8.7 First Offer. In the event that Micromet decides to transfer ownership of Micromet
Collaboration Technology to any 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
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





 




			
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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 20.2.




9. Prosecution, Enforcement and Defense of Patents 




     9.1 Prosecution and Maintenance of Patents.



          9.1.1 Micromet will have the sole right to file, prosecute and maintain Patents in the
Licensed Technology (including Patents within Joint Collaboration Technology). MedImmune will
reimburse Micromet for [***]% of Micromet’s reasonable and documented out-of-pocket costs incurred
in connection with the filing and prosecution of Patents included in the Joint Collaboration
Technology inside or outside the Territory. MedImmune will cooperate with Micromet to file,
prosecute and maintain such Patents inside or outside the Territory, and will have the right to
review and provide comments to Micromet relating to such patent applications and patents. For all
other Patents, the person or entity owning the Patent will pay the costs and expenses thereof.




          9.1.2 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.




          9.1.3 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.




     9.2 Enforcement of Patents.



          9.2.1 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.




          9.2.2 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





 




			
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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) Within the Territory, with respect to the alleged infringement by a Third Party of
Licensed Technology by making, using, selling, importing or offering for sale a Licensed Product,
subject to the rights of any licensor of Licensed Technology under 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 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.



          9.2.3 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 under MedImmune Collaboration Technology with respect to a Third Party
making, using, selling, offering for sale or importing Licensed Product 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.




          9.2.4 Cooperation; Damages. If one Party brings any enforcement action or proceeding under
this Section 9 with respect to Licensed 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 9.2 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.




     9.3 Third Party Patents. If any notice of infringement is received by, or a suit is initiated
against, either Party with respect to Licensed 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



34









 








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 Licensed 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 10.4.3.



10. Fees and Payments 




     10.1 Technology Access Fee. MedImmune will pay to Micromet a non-refundable, non-creditable
annual technology access fee of €[***] in equal quarterly installments, each payable within 30
days after the end of the applicable calendar quarter during the first 2 years following the
Effective Date. The Parties will negotiate the amount of the annual technology access fee, if any,
payable during each year thereafter.



     10.2 Development Milestones. MedImmune will make the following non-refundable, non-creditable
payments to Micromet in the amounts set forth below within 30 days of the occurrence of the
following events with respect to each Licensed Product in the Territory:



	 	 	 	 	 
	Milestone Event	 	Milestone Payment
	1.

	 	Upon filing of the first IND or equivalent filing
in any country of the Territory
	 	US$[***]
	 
	 	 	 	 
	2.

	 	First patient enrolled in first Pivotal Trial for
any country of the Territory
	 	US$[***]
	 
	 	 	 	 
	3.

	 	Filing of the first BLA for such Licensed Product
	 	US$[***]
	 
	 	 	 	 
	4.

	 	Filing of the second BLA for such Licensed Product
	 	US$[***]
	 
	 	 	 	 
	5.

	 	Approval of the first BLA for such Licensed Product
	 	US$[***]
	 
	 	 	 	 
	6.

	 	Approval of the second BLA for such Licensed
Product
	 	US$[***]





Notwithstanding the foregoing, if the Lead Product is not MT103, then MedImmune will not be
required to make any milestone payment that MedImmune has earlier paid in connection with the
development of a predecessor of the then-current Lead Product.




     10.3 Commercialization Milestones. MedImmune will make the following non-refundable one-time
payments to Micromet in the amounts set forth below within 30 days of the occurrence of the
following events with respect to Licensed Product sold in the Territory by MedImmune, its
Affiliates or sublicensees:





 




			
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	Milestone Event	 	Milestone Payment
	The first time that Net Sales of Licensed
Product in the Territory reaches US$[***] in a
calendar year

	 	US$[***]
	 
	 	 
	The first time that Net Sales of Licensed
Product in the Territory reaches US$[***] in a
calendar year

	 	US$[***]





[***]% of the milestone payments made pursuant to this Section 10.3 are creditable against the
royalties due to Micromet pursuant to Section 10.4 below; provided, however, that MedImmune may
take such credit only to the extent that each such royalty payment due to Micromet is not reduced
by more than [***]% of the payment that would be due without such credit.




     10.4 Royalties.



          10.4.1 Royalty Rates.




               (a) Subject to the adjustments provided for in Section 10.4.3 MedImmune will pay to Micromet a
royalty equal to:



                    (i) [***]% of Net Sales of Licensed Product in the Territory for that portion of the total
amount of aggregate Net Sales of Licensed Product in the Territory during a calendar year that is
less than or equal to US$[***];



                    (ii) [***]% of Net Sales of Licensed Product in the Territory for that portion of the total
amount of aggregate Net Sales of all Licensed Product in the Territory during a calendar year that
is greater than US$[***] but less than or equal to US$[***]; and



                    (iii) [***]% of Net Sales of Licensed Product in the Territory for that portion of the total
amount of aggregate Net Sales of all Licensed Product in the Territory during a calendar year that
is greater than US$[***].



               (b) In the event that a Licensed Product is sold in combination with a therapeutically active
component that is not a Licensed Product (“Combination Product”), then net sales (calculated as Net
Sales) of such Combination Product upon which a royalty is paid will be subject to the following
adjustment. If the Licensed Product and the other therapeutically active component of the
Combination Product are sold separately in a country, then net sales of such Combination Product in
such country upon which a royalty is paid will be multiplied by the fraction A/A+B, where A equals
the average sales price of such Licensed Product sold separately in such country, and B equals the
average sales price of the other therapeutically active component sold separately in such country.
Otherwise, the parties will enter into good faith negotiations and attempt to reach mutual
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the net sales of such Combination Product in a
country to reflect the relative contributions of the Licensed Product and the other therapeutically
active component to the value of the Combination
Product in such country. If such mutual agreement is not reached within ninety (90) days
after commencement of such negotiations, then the determination will be submitted to binding
arbitration under Section 20.4.3.




               (c) Only one royalty will be due and payable for the manufacture, use and sale of Licensed
Product irrespective of the number of Valid Claims within the Licensed Technology that cover the
manufacture, use and sale of Licensed Product. Upon payment of a royalty under this Agreement with
respect to a unit of Licensed Product, no further royalty will be due with respect to such unit of
Licensed Product.



          10.4.2 Royalty Term. Royalties due under the preceding Section 10.4.1 for Licensed Product
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 Licensed Product in the country
of the Territory where sold, or (ii) [***] from the first commercial sale of such Licensed
Product in the Territory (the “Royalty Term”).




          10.4.3 Royalty Adjustments.




               (a) In the event that one or more Third Parties sell a Licensed 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 Licensed Product by such Third Parties amounts to [***] percent ([***]%) of
MedImmune’s sales of Licensed Product in such country in a calendar year, then the royalty payable
by MedImmune pursuant to Section 10.4.1 on Licensed Product in such country for such calendar year
will be reduced to [***]%. If sales by such Third Parties are only for a portion of a calendar
year, the [***]% of MedImmune’s sales 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 Licensed Product by MedImmune against
the amount of any royalties due and payable by MedImmune pursuant to Section 10.4.1; provided,
however, that in no event will such credit reduce the amount of royalties due and payable by
MedImmune to Micromet to less than [***]% of Net Sales of Licensed Product.



               (c) The royalty rate adjustments set forth in Sections 10.4.3 (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 10.4.1 on Licensed Product to less than [***]% of Net Sales of
Licensed Product.



11. Payment Terms




     11.1 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





 




			
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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 in
effect on the due date, or (ii) the maximum rate permitted by law, calculated on the number of days
such payment is delinquent, compounded monthly.




     11.2 Payment Schedules; Reports. Royalty payments due pursuant to Sections 4.11.2 and 10.4
are due and payable within [***] of the end of each calendar quarter during the Term during which
there were Net Sales of the applicable product in the Territory. A Party will accompany each
payment of royalties under this Agreement with a report containing a detailed account of Net Sales
of each product for which royalties are due during the preceding calendar quarter.



     11.3 Records Retention; Audit.



          11.3.1 Record Retention. Each Party will maintain complete and accurate books, records and
accounts used for the determination of expenses incurred in connection with the performance of the
Development Plan and Net Sales, in sufficient detail to confirm the accuracy of any payments
required under this Agreement, which books, records and accounts will be retained by such Party
until [***] years after the end of the period to which such books, records and accounts pertain.




          11.3.2 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.




          11.3.3 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
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          11.3.4 Confidentiality. Each party will treat all information subject to review under this
Section 11.3 in accordance with the provisions of Section 12 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.




12. Confidentiality




     12.1 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).



     12.2 Exclusions.



          12.2.1 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;



               (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 12 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.



          12.3 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






 




			
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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.




     12.4 Authorized Disclosure. Each Party may use and disclose Confidential Information of the
other Party to the extent that such use and disclosure is:



          12.4.1 made in response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided, however, that such Party will
first have given notice to such other Party and given such other Party a reasonable opportunity to
quash such order and to obtain a protective order requiring that the Confidential Information and
documents that are the subject of such order be held in confidence by such court or governmental or
regulatory body or, if disclosed, be used only for the purposes for which the order was issued; and
provided, further, that if a disclosure order is not quashed or a protective order is not obtained,
the Confidential Information disclosed in response to such court or governmental order will be
limited to that information which is legally required to be disclosed in response to such court or
governmental order;




          12.4.2 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;




          12.4.3 made by such Party to the regulatory authorities as required in connection with any
filing of MAAs, 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;




          12.4.4 made by such Party, in connection with the performance of this Agreement, to
Affiliates, permitted sublicensees, research parties, employees, consultants, representatives or
agents, each of whom prior to disclosure must be bound by obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Section 12;




          12.4.5 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 12; provided, however, that 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 Licensed Products without first
providing such other Party with reasonable advance written notice of each such disclosure; or




          12.4.6 made in a patent application filed in conformance with this Agreement.




40









 








          12.5 Terms of Agreement to be Maintained in Confidence. Subject to the provisions of this
Section 12, 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.




13. Public Communications




     13.1 General Provisions. The Parties will cooperate with respect to the timing and content of
communications with the public regarding the development and marketing of Licensed Product, under
the terms to be set forth in the Development Plan and subject to the provisions of this Section 13.



     13.2 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.



     13.3 Press Releases.



          13.3.1 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 [***] 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.




          13.3.2 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.




          13.3.3 A Party may publicly disclose without regard to the preceding requirements of this
Section 13.3 information that was previously disclosed in a Proposed Disclosure that was in
compliance with such requirements.




     13.4 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





 




			
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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.




14. Convertible Note 




     On the Effective Date, MedImmune will execute the agreement attached as Exhibit G hereto.



15. Term and Termination




     15.1 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 Licensed Products, and (ii) fifty years from the Effective Date,
unless earlier terminated as provided in this Agreement.



     15.2 Breach.



          15.2.1 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 Sections 3.2.7 and 6.3, with respect to a particular Licensed Product in a particular country
of the Territory unless such breach is cured in [***] ([***] for a payment breach). 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 20.4.3, 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 Licensed Product in the applicable
country of the Territory and MedImmune will have no further obligations under this Agreement except
those set forth in Section 16. In the event that MedImmune disputes a payment obligation for which
Micromet provides notice under this Section 15.2.1 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 20.4.3 whether or not MedImmune is obligated to make such payment
and to the extent MedImmune prevails in such arbitration, Micromet will return such disputed
payments to MedImmune.




          15.2.2 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 granted to Micromet under this Agreement in the entirety unless such breach
is cured in [***] ([***] for a payment breach). 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 20.4.3, then, upon expiration of the applicable period, the
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the entirety and Micromet will
have no further obligations under this Agreement except those set forth in Section 16. In the
event that Micromet disputes a payment obligation for which
MedImmune provides notice under this Section 15.2.2 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 20.4.3 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.




     15.3 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 and if the licenses granted to MedImmune are terminated in
the entirety, then MedImmune will have no further obligations under this Agreement except for those
set forth in Section 16 and, if the licenses granted to MedImmune are terminated in one or more
countries, then MedImmune will have no further payment obligations with respect to such countries.



16. Effects of Termination 




     16.1 Post-Termination Activities.



          16.1.1 Upon termination of the rights and licenses granted to MedImmune in its entirety, and
subject to any rights retained by MedImmune’s sublicensees in the Territory pursuant to Section
16.7, Micromet will have the right to continue the development of and to Commercialize Licensed
Product by itself or with or through Third Parties anywhere in the world. Upon such termination,
MedImmune will upon request of Micromet:




          (a) continue the Development Activities set forth in the Development Plan relating to clinical
trials commenced by or on behalf of MedImmune prior to the effective date of such termination, at
the cost and expense of Micromet, or upon request by Micromet and subject to Applicable Law and to
MedImmune’s obligations to Third Parties conducting such Development Activities on behalf of
MedImmune, transfer such Development Activities to Micromet;




          (b) transfer the then-existing clinical scale manufacturing process for the Lead Product or,
if applicable, the fully-developed Lead Product Process to Micromet or its designee under the terms
set forth in Section 5;




          (c) provide Micromet with Clinical Trial Materials (if, at the time of such termination,
MedImmune is supplying Micromet with Clinical Material) until such time as Micromet or its designee
has established and validated a manufacturing process for one or more Licensed Products and is
approved to manufacture Pivotal Trial and commercial supplies of such Licensed Products (but in no
event longer than [***] from completion of the transfer of the manufacturing process described in
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               (d) transfer to Micromet all non-clinical and clinical data, information, regulatory
approvals, and Know-How directly related to Licensed Product (other than that directed to a
Commercial Process), and any trademarks relating to Licensed Product.



          16.1.2 In consideration of the performance of the obligations set forth in the preceding
Section 16.1.1, Micromet will pay MedImmune:




               (a) in the event of termination pursuant to Section 15.3, 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 the transfer of
materials described in clause (b) of Section 16.1.1;



               (b) the [***] for Clinical Trial Materials, on the terms set forth in Section 4;



               (c) if, at the time of such termination, MedImmune is supplying Micromet with Licensed
Product, for commercial supply of Licensed Product, under the terms set forth in the applicable
supply agreement executed by the Parties pursuant to Section 4.11 or, if no such agreement has been
executed, under the terms set forth in Section 4; and



               (d) the royalty set forth in Section 4.11.2(b) above, and the payments of Section 7.5.3.



               16.1.3 If the licenses granted to Micromet under this Agreement are terminated in the entirety
pursuant to Section 15.2.2, then MedImmune will have the right to continue the development of and
to Commercialize Licensed Product 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 a 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 and
associated data generated pursuant to such Research Plan, and



               (b) MedImmune will provide Micromet with Clinical Trial Materials (if, at the time of such
termination, MedImmune is supplying Micromet with Clinical Material) 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.



     16.2 Effect of Expiration on Intellectual Property. Upon expiration of this Agreement
pursuant to Section 15.1 above, (a) the licenses and sublicensing rights granted in Sections 8.1.1
and 8.1.3 by Micromet to MedImmune will become fully paid, perpetual, and irrevocable, and (b) the
licenses granted in Section 8.2 by MedImmune to Micromet will become fully paid, perpetual, and
irrevocable.





 




			
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     16.3 Effects of Termination on Licenses.



          16.3.1 If the licenses granted to MedImmune under this Agreement are terminated in the
entirety pursuant to Section 15.2.1 or Section 15.3, then the licenses granted to




          Micromet under this Agreement will continue in full force and effect under the terms and
conditions of this Agreement, except that the licenses granted to Micromet under Section 8.2 will
be extended to include the Territory and 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; provided, however, 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 16.7.




          16.3.2 If the licenses granted to MedImmune under this Agreement are terminated with respect
to any Licensed Product in one or more countries in the Territory pursuant to Section 15.2.1 or
with respect to any country pursuant to Section 15.3, then the licenses granted to Micromet under
this Agreement will be extended to each such Licensed Product in each such country or countries,
and Micromet’s and MedImmune’s obligations under this Agreement with respect to such licenses and
any Patents and Know-How covered thereunder will also be extended thereto; provided, however, 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 16.7.




          16.3.3 If the licenses granted to Micromet under this Agreement are terminated pursuant to
Section 15.2.2, then the licenses granted to MedImmune under this Agreement will remain in full
force and effect under the terms and conditions of this Agreement, and Micromet’s and MedImmune’s
obligations with respect to such licenses and any Patents and Know-How covered thereunder will
remain in full force and effect.




     16.4 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.



     16.5 Survival. Sections, 3.4.2, 7.1, 7.2, 7.3, 7.4, 8.1.2, 8.2.7, 9.1.1, 11, 12, 13.2, 16,
17, 19 and 20 (except for Section 20.2.2), and the limitation on remedies set forth in Sections
3.2.6(d), 3.2.7(a) and 6.3.2, 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 4 and 5 will survive any termination or expiration of this Agreement to the
extent such provisions are necessary to effect the activities described in this Section 16.



     16.6 Inventory. During a period of [***] following any termination of this Agreement
MedImmune will be entitled, at its option, to sell any completed inventory of Licensed Product
which remains on hand as of the date of the termination under the licenses





 




			
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granted under this
Agreement, so long as MedImmune pays to Micromet the royalties applicable to such subsequent sales
in accordance with the same terms and conditions as set forth in this Agreement.




     16.7 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 Licensed 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 Licensed 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 16.7 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, and to develop the Lead Product
Process may not be transferred to any sublicensee pursuant to this Section 16.7.



17. Indemnification and Insurance 




     17.1 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 (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 Licensed Product in the Territory by
MedImmune, its Affiliates or sublicensees (other than Licensed Product provided to Micromet or its
Affiliates or licensees); in each case, excluding any Losses for which Micromet has an obligation
to indemnify one or more MedImmune Indemnitees pursuant to Section 17.2.



     17.2 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, its Affiliates or sublicensees in performing any activity contemplated by this Agreement,
(b) the development or Commercialization of Licensed Product outside the Territory by Micromet, its
Affiliates or sublicensees (and countries inside the Territory in the event that Micromet’s license
is extended to countries of the Territory under Section 16.3.1 and/or 16.3.2), or (c) the research,
development, manufacture or sale of BiTE Product by Micromet, its Affiliates or sublicensees
pursuant to a license granted to Micromet under this Agreement; in each case, excluding any Losses
for which MedImmune has an obligation to indemnify one or more Micromet Indemnitees pursuant to
Section 17.1.



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     17.3 Notice of Claim. All indemnification claims in respect of any MedImmune Indemnitee or
Micromet Indemnitee seeking indemnity under Sections 17.1 or 17.2 (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 17.1 or Section 17.2, 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.



     17.4 Control of Defense. At its option, the Indemnifying Party may assume the defense of any
claim subject to indemnification as provided for in Sections 17.1 and 17.2 (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.



     17.5 Right to Participate in Defense. Without limiting Section 17.4, 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 17.4 (in which case the Indemnified Party will control
the defense).



     17.6 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 17.4, the Indemnifying Party will have
authority to consent to the entry of any



47









 




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.




     17.7 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.



     17.8 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 complete copy of its policies of
insurance in that regard, along with any amendments and revisions thereto.



18. Representations and Warranties




     18.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other Party that, as of the Effective Date:



          18.1.1 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;




          18.1.2 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;




          18.1.3 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




48









 







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.




     18.2 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 the Technology Acquisition
Agreements of Exhibit C and that the Patents of Exhibit A-2 have been sublicensed to MedImmune in
the Territory under this Agreement;



               (d) Micromet (i) owns all right, title and interest in and to the MT103 Patents with respect
to [***] and [***], (ii) believes that it owns all right, title and interest in and to the MT103
Patents with respect to [***], and (iii) will use commercially reasonable efforts to resolve the
[***] with respect to [***] interest in the MT103 Patents;



               (e) 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;



               (f) prior to the Effective Date, it has provided to MedImmune access to all material
information and data in Micromet’s possession and control regarding the safety and efficacy of
Licensed Product and 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;



               (g) 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 expressly threatened
such a claim) asserting the invalidity, unenforceability or misuse of any Patent included in
Licensed Technology;



               (h) to the knowledge of Micromet’s officers as of the Effective Date, other than Patents
licensed or optioned to MedImmune under this Agreement, no Patent owned or controlled by a Third
Party would be infringed by manufacture, use or sale of Licensed Product in the Territory; and





 




			
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               (i) 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 Licensed Product or
manufacture or use thereof are listed in Exhibit C, (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.



     18.3 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.



19. Disclaimer; Limitation of Liability




     19.1 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.



     19.2 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 INFRINGEMENT AND WILL NOT LIMIT EITHER PARTY’S LIABILITY
AND OBLIGATIONS TO THE OTHER PARTY UNDER SECTIONS 12 AND 17.



20. Miscellaneous




     20.1 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),



50









 







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.



     20.2 Assignment.



          20.2.1 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.




          20.2.2 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, in each case only as to
MedImmune, with respect to any Licensed Product or Commercial Process 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; provided, however, 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
assignment is subject to this Agreement, and that the assignee assumes in writing the assigning
Party’s obligations under this Agreement.




     20.3 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





 




			
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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.




     20.4 Governing Law; Dispute Resolution.



          20.4.1 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.




          20.4.2 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 20 days 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.




          20.4.3 If a Dispute is not resolved as provided in the preceding Section 20.4.2, 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 decision or award will be only in accordance with the terms and conditions of this Agreement.
The Parties will exert best efforts to have the decision and award rendered within [***] after the
first to occur of (i) notice of breach of this Agreement, which breach is a subject of the
arbitration, and (ii) a notice invoking this arbitration provision. Judgment upon the award may be
entered in any court having jurisdiction thereof. Any arbitration pursuant to this section will be
held in Washington, D.C. or such other place as may be mutually agreed upon in writing by the
Parties. With respect to any disputes arising in connection with an alleged breach of a Party’s
rights and obligations with respect to confidential Know-How or Confidential Information received
from the other Party, the arbitrator will apply the discovery provisions of the Federal Rules of
Civil Procedure. This means that depositions may be taken and full






 




			
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discovery may be obtained in
any arbitration commenced under this Section 20.4 with respect to such disputes.




          20.4.4 Notwithstanding the provisions of this Section 20.4, 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 20.4 will not apply with respect to any claim of a Party
that the other Party is infringing any of its patents.




     20.5 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.

35 W. Watkins Mill Road

Gaithersburg, MD 20878

USA

Attention: Legal Department

Facsimile: (301)527-4214



After January 1, 2004



MedImmune, Inc.

One MedImmune Way

Gaithersburg, MD 20878, USA

Attention: Legal Department

Facsimile: (301) 527-4214



If to Micromet, to:

Micromet AG

Staffelseestrasse 2

81477 Munich

Germany

Attention: Chief Business Officer

Facsimile: ++49 89 895 277 205





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with a copy to:



Cooley Godward, LLP

One Freedom Square

Reston Town Center

11951 Freedom Drive

Reston, Virginia 20190-5656

Attention: Matthias Alder

Facsimile: (703) 456-8100



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 20.5 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.




     20.6 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.



     20.7 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.



     20.8 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.



54









 





     20.9 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.



     20.10 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.



     20.11 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.



     20.12 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.



     20.13 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]




55









 








     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/ Christian Itin
	 	By:
	 	/s/ David M. Mott
	Name:

	 	Christian Itin
	 	Name:
	 	David M. Mott
	Title:

	 	Chief Business Officer
	 	Title:
	 	CEO
	 
	 	 	 	 	 	 
	By:

	 	/s/ G.K. Mirow	 	 	 	 
	Name:

	 	G.K. Mirow	 	 	 	 
	Title:

	 	Chief Financial Officer	 	 	 	 






[Signature Page to the Collaboration and License Agreement]





56









 













Exhibit A-1




Issued Patents and Published Patent Applications of Micromet

(as of the Effective Date)




	 	 	 	 	 	 	 
	 	 	 	 	Patent /	 	 
	 	 	 	 	Application	 	 
	Country	 	Title of Application	 	Number	 	Comment/Status
	[***]

	 	[***]
	 	[***]
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	 	[***]
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	***	 	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.






 









 











Exhibit A-2




Issued Patents and Published Patent Applications 

licensed by Micromet

(as of the Effective Date)




	 	 	 	 	 	 	 	 	 	 	 	 	 
	Application	 	Application	 	 	 	 	 	 	 	Patent	 	Date of
	Number	 	Filing Date	 	Country	 	Title of Application	 	Status	 	Number	 	Grant
	[***]

	 	[***]
	 	[***]
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	***	 	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.




 









 










	 	 	 	 	 	 	 	 	 	 	 	 	 
	Application	 	Application	 	 	 	 	 	 	 	Patent	 	Date of
	Number	 	Filing Date	 	Country	 	Title of Application	 	Status	 	Number	 	Grant
	[***]

	 	[***]
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	 	[***]
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	 	[***]	 	 	 	 





Licensed by Micromet from [***]

As per Licensing Agreement of September 2000



I. Patents based on Swiss Patent Application [***]




	 	 	 	 	 	 	 	 	 	 	 
	Country	 	Appln.-No.	 	Patent-No.	 	Expiry Date	 	Status	 	Type
	[***]

	 	[***]
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	 	[***]	 	 
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	 	[***]





II. Patents based on Swiss Patent Application [***]




	 	 	 	 	 	 	 	 	 	 	 
	Country	 	Appln.-No.	 	Patent-No.	 	Expiry Date	 	Status	 	Type
	[***]

	 	[***]
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	***	 	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









 









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
[***] 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.




3









 












Exhibit A-3




Published Patent Applications of Micromet

(subject to challenge 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.




 









 












Exhibit B




MT103 Sequence



MT103 Amino Acid Sequence

[***]






 




			
	***	 	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.




 









 












Exhibit C




Micromet 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.




 









 












Exhibit D




[***] 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.




 









 












Exhibit E




Development Plan for MT103




[Exhibit begins on following page.]





 









 










ARTICLE 1 — MT103 Clinical Development Plan




General assumptions:

[***]




ARTICLE 2 — Phase I/II studies




Terminated studies:





	 	1.	 	MT103/I-01-2001; [***]

[***]





Currently ongoing studies:





	 	2.	 	MT103/I-01-2002; [***]

[***]
	 
	 	3.	 	MT103/I-02-2002; [***].

[***]





Currently planned studies:





[***]




[***]




	 	a.	 	[***]






[***]



Additional studies



[***]






 




			
	***	 	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.




 









 










Different routes of administration



[***]



Non-invasive patient studies



[***]



Proof of efficacy



[***]



End of Phase II decision points



[***]



Phase III studies/other studies for BLA filing




     [***]


CLL



[***]



Safety population



[***]



Timelines



[***]






 




			
	***	 	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









 










	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	2003	 	 	2004	 
	 	 	1Q	 	 	2Q	 	 	3Q	 	 	4Q	 	 	1Q	 	 	2Q	 	 	3Q	 	 	4Q	 
	Process related
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Transfer @ 100L
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Trial runs & evaluation @ MEDI
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Process optimization
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Stability of representative material
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Viral clearance (1)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Cell line
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Bulk harvest testing inkl. VLP (2)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	End of production cell bank
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	MCB Characterization (3)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Analytical methods
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Validation potency assay
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Two-sided binding assay (4)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Removal of contaminants (5)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	MT103 PK assay (6)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Assay for anti-MT103 Abs (Immunogenicity)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Multimer characterization
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Degradation pathways
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Formulation
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Lyophilization cycle opt.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	In vitro pharmacology
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Toxicity studies
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Tissue Cross Reactivity w/ MT103(7)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	General tox at high dose (8)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IND Filing
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 






 





							
	NOTES:

	 	 	(1	)	 	Studies to validate viral clearance; additional viruses and process steps to be evaluated.
	 
	 	 	 	 
	 

	 	 	(2	)	 	Additional EOP testing (retroviral quantitation) may be needed on the unpurified bulk; next CTM production (either CMO or MEDI)
	 
	 	 	 	 
	 

	 	 	(3	)	 	MCB testing doesn’t fulfill the safety requirements in FDA PTC for mfg of mAbs (XC assay, RT assay, and in vivo adventicious agents)
	 
	 	 	 	 
	 

	 	 	(4	)	 	Develop a two-sided binding assay; Biacore for CD3 and CD19.
	 
	 	 	 	 
	 

	 	 	(5	)	 	Additional assays needed to quantify removal of process and product-related contaminants.
	 
	 	 	 	 
	 

	 	 	(6	)	 	Develop a robust assay; consider generating an anti-idotype antibody assay.
	 
	 	 	 	 
	 

	 	 	(7	)	 	Conduct TCR studies with MT103 compound to show binding to tissues known to be positive and negative for CD3 and CD19.
	 
	 	 	 	 
	 

	 	 	(8	)	 	Conduct general toxicity study in non-relevant species at high MT103 dose level.





[***]






 




			
	***	 	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









 












Exhibit F




Process Royalties Upon [***]




	 	 	 
	 	 	Royalty Rate upon
	[***]	 	repayment of costs
	[***]

	 	[***]%
	 
	 	 
	[***]

	 	[***]%
	 
	 	 
	[***]

	 	[***]%








 




			
	***	 	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.




 









 











Exhibit G




Convertible Note




[see Second Amended and Restated Note, dated December 27, 2006, incorporated by reference to Micromet’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 4, 2007]