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):
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(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 in
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