COLLABORATION AND LICENSE AGREEMENT
Exhibit 10.1
This Collaboration and License Agreement (the “Agreement”) is made and entered into effective
as of May 24, 2007 (the “Effective Date”), by and between Micromet AG, having its
principal place of business at Xxxxxxxxxxxxxxxxx 0, 00000, Xxxxxx, Xxxxxxx (“Micromet”), and
Altana Pharma AG, a wholly owned subsidiary of Nycomed A/S, having its principal place of
business at Byk Xxxxxx Xxx. 0, 00000 Xxxxxxxx, Xxxxxxx (“Nycomed”). Micromet and Nycomed each may
be referred to herein individually as a “Party,” or collectively as the “Parties.”
Recitals
A. Micromet is developing
the MT203 Product, an anti-GM-CSF [***].
B. Nycomed is a pharmaceutical company with experience in the development and
commercialization of pharmaceutical products.
C. Micromet and Nycomed desire to exclusively collaborate on the development of one or more
products binding to and inhibiting the activity of GM-CSF in order to obtain marketing approval of
such products for various indications, and thereafter to have Nycomed commercialize such products.
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 shall 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 shall 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 “Antibody” means a molecule or gene encoding such a molecule comprising or containing at
least one immunoglobulin variable domain or parts of such domain or any existing or future
fragments, variants, modifications or antibody derivatives thereof.
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1.3 “Applicable Law” means the laws, rules, and regulations, including any statutes, rules,
regulations, guidelines, or other governmental requirements that may be in effect from time to time
and apply to the development, manufacture, registration, and marketing of a Product in the
countries of the Territory, including any such statutes, rules, regulations, guidelines, or other
requirements of the FDA or the EMEA or other national or international bodies relevant for
medicinal or medical products, including devices, materials and services required for application
of a pharmaceutical product.
1.4 “Bioequivalent Product” means, with respect to a particular Product, any Third Party
pharmaceutical product that contains an anti-GM-CSF [***] or an [***], in each case, with
[***] and [***] to the Product.
1.5 “BITE” means a bi-specific Single Chain Antibody wherein one arm of the Single Chain
Antibody binds to T-cells.
1.6 “BLA” means a Biologics License Application for submission to the FDA and the equivalent
application in jurisdictions outside the United States of America, including a Marketing Approval
application for submission to the EMEA, in each case in conformance with Applicable Law.
1.7 “Change in Control” means (i) a sale, lease, license or other disposition of all or
substantially all of the assets of a person or entity (in one transaction or a series of related
transactions), or (ii) any sale, exchange or other transfer to a Third Party (or several Third
Parties acting together) of shares representing more than fifty percent (50%) of the aggregate
ordinary voting power represented by the issued and outstanding stock of a person or entity,
whether such transfer is made directly or indirectly, beneficially or of record.
1.8 “Clinical Failure” means any of the following: (i) receipt of a written order by a
Regulatory Authority to cease development in a clinical trial in one or more Indications of the
MT203 Product; or (ii) a determination [***] by [***] or [***] (1) that the continued development
of the MT203 Product would not be ethical or in the best interest of patient safety or (2) that the
MT203 Product has failed to achieve the primary efficacy endpoints [***] based upon an applicable
final or interim study report.
1.9 “Collaboration Technology” means Joint Collaboration Technology, Micromet Collaboration
Technology, and Nycomed Collaboration Technology.
1.10 “Commercialization” means the manufacture, marketing, promotion, advertising, selling and
distribution of a Product in a country after Marketing Approval has been obtained in such country.
The term “Commercialize” has a correlative meaning.
1.11 “Commercially Reasonable Efforts” means the level of efforts consistent with the
reasonable best practices of the pharmaceutical industry and the exercise of prudent scientific and
business judgment for the development and commercialization of a pharmaceutical product having
similar market potential, profit potential or strategic value, based upon conditions then
prevailing. Without limiting the foregoing, Commercially Reasonable Efforts requires, with respect
to such an obligation, that the Party: (a) within a reasonable time assign responsibility for such
obligation to specific employee(s) who are held accountable for progress and monitor
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such progress on an on-going basis, (b) set and consistently seek to achieve specific,
meaningful and measurable objectives for carrying out such obligation, and (c) consistently make
and implement decisions and allocate resources designed to advance progress with respect to such
objectives.
1.12 “Control” and, with correlative meaning, the term “Controlled”, means, with respect to a
Party and any Patent, Know-How, or other intellectual property right, the ability to grant the
other Party access, a license, a sublicense or the right to use (as applicable) 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 Expenses” means, with respect to a Party, all costs and expenses incurred by
a Party in carrying out any activities to be performed pursuant to the Development Plan, calculated
in accordance with generally accepted accounting principles consistently applied and such Party’s
cost accounting systems, provided that the cost of a Party’s FTEs performing such activities shall
be calculated at the FTE Rate.
1.14 “Development Plan” has the meaning as defined in Section 3.2.1.
1.15 “EMEA” means the European Medicines Agency, or any successor agency thereto.
1.16 “European Union” means those countries that during the Term are member states of the
European Union.
1.17 “FDA” means the United States Food and Drug Administration, or any successor agency
thereto.
1.18 “Field” means the treatment of human diseases and conditions.
1.19 “FTE” means the full time equivalent of a total of [***] working hours per year of
scientific or technical or managerial work on or directly related to the execution or
implementation of the Development Plan, or other tasks to be performed under this Agreement,
carried out by a qualified employee or consultant of a Party. Scientific or technical work may
include, but is not limited to, research, experimental laboratory work, developing manufacturing
processes for a Product, conducting pre-clinical and clinical development of a Product, recording
and writing up results, reviewing literature and references, holding scientific discussions, and
attending conferences in the relevant field.
1.20 “FTE Cost” means the product of (a) the number of FTEs, which are documented using a
reasonably reliable tracking system and (b) the FTE Rate. The tracking system should include
employee’s function, performed tasks, and corresponding hours performed by the employee.
1.21 “FTE Rate” means [***] per FTE, which amounts include, for each FTE, laboratory supplies
and equipment (excluding items provided for separately under the applicable
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Development Plan), equipment maintenance costs, utilities, waste removal, and a pro rata
allocation of general and administrative expenses plus facilities expenses.
1.22 “GM-CSF” means the whole or part and natural variants of the granulocyte-macrophage
colony stimulating factor (GM-CSF) identified by the [***] entry name [***] and accession number
[***] with the amino acid sequence as set out in Exhibit G.
1.23 “IND” means an Investigational New Drug Application for submission to the FDA, and the
equivalent application in jurisdictions outside the United States of America, including
Investigational Medicinal Product Dossier for submission to a Regulatory Authority in Europe.
1.24 “Indication” means any discrete disease pattern in the Field for which a BLA,
supplemental BLA, Marketing Approval application or similar Regulatory Filing may be made.
1.25 “Joint Collaboration Technology” means any Patents claiming or covering a discovery or
invention conceived, and any Know-How generated, jointly by employees, agents or independent
contractors of both Parties 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 “JSC” has the meaning as defined in Section 2.2.
1.27 “Know-How” means (a) any scientific or technical information, results and data of any
type whatsoever, in any tangible or intangible form whatsoever, that is not in the public domain or
otherwise publicly known, including databases, practices, methods, techniques, specifications,
formulations, formulae, knowledge, know-how, skill, experience, test data including
pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical
test data, analytical and quality control data, stability data, studies and procedures, and
manufacturing process and development information, results and data, and (b) any biological,
chemical, or physical materials that are not in the public domain or otherwise available to the
public; all to the extent not claimed or disclosed in a Patent.
1.28 “Licensed Know-How” means (a) any Know-How Controlled by Micromet as of the Effective
Date, (b) any Know-How included in the Micromet Collaboration Technology, or (c) any Know-How
included in the Joint Collaboration Technology (but only with respect to Micromet’s rights and
interest in such Joint Collaboration Technology), to the extent such Know-How is necessary or
useful for the research, development, use, or Commercialization of a Product in the Field.
1.29 “Licensed Patents” means (a) any Patents Controlled by Micromet during the Term that
claim any invention or discovery included within any Know-How Controlled by Micromet as of the
Effective Date, Micromet Collaboration Technology or Micromet’s interest in Joint Collaboration
Technology, to the extent necessary or useful for the research, development, import, use or
Commercialization of a Product and (b) all of the Patents listed on Exhibit A.
1.30 “Licensed Technology” means the Licensed Patents, any Sublicensed Patents,
and Sublicensed Know-How and the Licensed Know-How.
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1.31 “Major Market” means each of the United States of America, the United Kingdom, Germany,
France, Italy, Spain and Japan.
1.32 “Marketing Approval” means the approval of a BLA, and any pricing and reimbursement
approvals to the extent required by Applicable Law prior to the sale of pharmaceutical products in
a country.
1.33 “Micromet Collaboration Technology” means any Patents claiming or covering a discovery
or invention conceived, and any Know-How generated, solely by employees, agents or independent
contractors of Micromet 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.
1.34 “MT203 Product”
means any pharmaceutical product comprising the [***] with the
variable domain amino sequence set forth in Exhibit B.
1.35 “Net Sales” means the gross amount invoiced by Nycomed, its Affiliates or sublicensees
for sales of a Product to any Third Party (and in all cases amounts actually received to the extent
not invoiced), less any (a) [***] and [***] , including [***] ; (b) amounts allowed for [***] or
[***] ; (c) [***] and [***] charges to the extent included in the invoiced amount; (d) [***] or
other [***] paid in connection with such sales (but excluding [***] ); and (e) the [***] and
[***] [***] including [***] to [***] , but excluding any [***] or [***] . Any of the
deductions listed above that involve a payment by Nycomed, its Affiliates or sublicensees shall be
taken as a deduction in the calendar quarter in which the payment is actually made by such entity.
Any amounts received on account of transfers of a Product between Nycomed, its Affiliates or
sublicensees shall be excluded from the calculation of Net Sales, and Net Sales shall be calculated
based on the final sale of such transferred product by Nycomed, its Affiliates or sublicensees to
any Third Party. If Nycomed or its Affiliates or sublicensees receive non-cash consideration for
Product sold or otherwise transferred to a Third Party, Net Sales for such sale or transfer shall
be determined based on the average of the gross invoice prices charged to other Third Parties in
respect of cash sales of Product during the applicable reporting period.
1.36 “Nycomed Collaboration Technology” means any Patents claiming or covering a discovery or
invention conceived, and any Know-How generated, solely by employees, agents or independent
contractors of Nycomed 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.
1.37 “Patents” means (a) all patents, patent applications, utility models and design patents
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.
1.38 “Phase 2 Trial” means a clinical trial in human patient population to determine the safe
and effective dose range in the proposed therapeutic indication, as more fully defined in
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21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent in any foreign country.
1.39 “Phase 3 Trial” means a clinical trial in human patients designed to (a) establish that a
drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse
reactions that are associated with the drug in the dosage range to be prescribed; and (c) support
Marketing Approval of such drug, as more fully defined in 21 C.F.R. § 312.21(c), or its successor
regulation, or the equivalent in any foreign country.
1.40 “Pivotal Trial” means (a) Phase 3 Trial or (b) a Phase 2 Trial that is of appropriate
size and design 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 a BLA for such
pharmaceutical product or label expansion of such pharmaceutical product. For clarity, the
determination of whether a Phase 2 Trial is a Pivotal Trial for purposes of this Agreement shall be
based upon a determination by the relevant Regulatory Authority that such trial could be
sufficient, depending on its outcome, to support the filing of a BLA for such pharmaceutical
product or label expansion of such pharmaceutical product.
1.41 “Product” means any (i) MT203 Product;
and (ii) any product comprising any [***] developed pursuant to this Agreement including any
fragment or Single Chain Antibody fragment thereof, in each of subsections (i) and (ii) that is
covered or claimed by, incorporates, comprises or was developed using the Licensed Technology. The
definition of “Product” shall exclude in all cases any composition or formulation of a product
comprising a BITE molecule or fragment thereof.
1.42 “Regulatory Authority” means, in a particular country or jurisdiction, any applicable
government regulatory authorities or other bodies involved in granting approval to market or sell
a Product, including any pricing and reimbursement approvals, in such country or jurisdiction,
including, (a) in the United States, the FDA, and any successor government authority having
substantially the same function, (b) any non-United States equivalent thereof, and (c) in the
European Union, the EMEA and any national regulatory authority in any member state of the European
Union.
1.43 “Regulatory Filing” means any submission or application made or filed with a Regulatory
Authority, including any IND or BLA.
1.44 “SCA Patents” means those Patents identified on Exhibit F, and 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.
1.45 “Single Chain Antibody” or “SCA” means an Antibody comprising (a) a polypeptide segment
having a light chain variable region, (b) a polypeptide segment having a heavy chain variable
region, and (c) at least one peptide linker linking those polypeptides into a single chain
polypeptide.
1.46 “Sublicensed Know-How” means the Know-How Controlled by Micromet pursuant to the Upstream
Agreements.
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1.47 “Sublicensed Patents” means the Patents Controlled by Micromet pursuant to the Upstream
Agreements.
1.48 “Sublicensed Technology” means any Sublicensed Patents and Sublicensed Know-How.
1.49 “Territory” means all countries of the world.
1.50 “Third Party” means any entity other than Micromet, Nycomed or their respective
Affiliates.
1.51 “Upstream Agreement” means any of the agreements listed in Exhibit D and as may
be amended in accordance with Section 7.3.3.
1.52 “Valid Claim” means (a) an issued claim of an issued Patent that has not (i) expired or
been canceled, (ii) been declared invalid by a decision of a court or other appropriate body of
competent jurisdiction, from which no appeal is or can be taken, (iii) been admitted to be invalid
or unenforceable through reissue, disclaimer or otherwise, or (iv) been abandoned or disclaimed;
and (b) a claim included in a pending patent application that is being actively prosecuted and that
has not been (i) canceled, (ii) withdrawn from consideration, (iii) finally determined to be
unallowable by the applicable governmental authority (from which no appeal is or can be taken), or
(iv) abandoned or disclaimed, provided, however, that if a claim of a patent application has been
pending for more than [***] years, such claim shall not constitute a Valid Claim for the purposes
of this Agreement unless and until a Patent issues with such claim.
2. Collaboration Governance
2.1 Exclusive co-development. The Parties shall conduct in good faith the exclusive
collaboration on the terms set out below.
2.2 Establishment of Joint Steering Committee. Within [***] days following the Effective
Date, the Parties shall establish a joint steering committee (the “JSC”) to oversee the development
of the Products under this Agreement. Each Party shall appoint three employees to serve as their
representatives on the JSC. From time to time, on written notice to the other Party, Micromet and
Nycomed each may substitute any of its representatives on the JSC. Each Party shall designate one
of its members of the JSC as the “Co-Chair.” Subject to the provisions of this Section 2, the JSC
shall establish its own procedural rules for its operation. The JSC shall be disbanded upon the
earlier to occur of (a) anytime following the receipt of the first Marketing Approval of a Product,
at the option of Micromet, (b) anytime the Parties have ceased development of all Products under
this Agreement, or (c) the [***] anniversary of the Effective Date. Following any such
dissolution of the JSC and for the remainder of the Term, Nycomed shall provide Micromet with
quarterly written reports regarding the status of and plans for the development and
commercialization of all Products as applicable, including copies of Nycomed’s then-existing
development and commercialization plans, as applicable, for such Product and other such information
as may be reasonably requested by Micromet regarding such Product.
2.3 Tasks of the JSC. The JSC shall: (a) review and approve the Development Plan
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and any updates or amendments to the Development Plan and any budgets for such activities; (b)
monitor the progress of and coordinate the activities undertaken pursuant to the Development Plan;
(c) review the product lifecycle plans of the Parties for all 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 JSC in this Agreement. The JSC shall not have any
power to amend this Agreement and shall have only such powers as are specifically delegated to it
under this Agreement.
2.4 JSC Meetings. The JSC shall meet not less than once every calendar quarter. Meetings may
be held in person or by means of telecommunication (telephone, video, or web conferences); provided
that at least two meetings per year shall be held in person. The JSC may meet more frequently by
agreement of the Parties. The Co-Chairs shall be responsible for organizing the meetings of the
JSC and for distributing the agenda of the meetings. The Co-Chairs shall include on the agenda any
item within the scope of the responsibility of the JSC that is requested to be included by a Party,
and shall distribute the agenda to the Parties no less than one week before any meeting of the JSC.
Each Party may, in its discretion, invite non-voting employees, consultants or advisors (which
consultants and advisors shall be under an obligation of confidentiality no less stringent than the
terms set forth in Section 9) to attend any meeting of the JSC. Each Party shall bear its own
costs associated with holding and attending JSC meetings.
2.5 Meeting Minutes. The Co-Chairs (or their designee(s)) shall prepare the minutes of each
JSC meeting, and send it to all members of the JSC for review and approval within [***] days after
each meeting. Minutes shall be deemed approved unless any member of the JSC objects to the
accuracy of such minutes by providing written notice to the other members of the JSC within [***]
days of receipt of the minutes. In the event of any such objection that is not resolved by mutual
agreement of the Parties, such minutes shall be amended to reflect such unresolved dispute.
2.6 Decision Making.
2.6.1 The JSC shall take action on matters within its power by unanimous consent of the
Parties, with each Party having a single vote, irrespective of the number of representatives
actually in attendance at a meeting, or by a written resolution signed by the designated
representative of each Party.
2.6.2 If the JSC is unable to reach unanimous consent on a particular matter (such matter a
“JSC Dispute”), then either Party may provide written notice of such dispute to the other Party’s
senior executive management representative as may be designated by a Party. Such senior executive
management representative shall have appropriate decision making authority for the Party and not be
a member of the JSC. The senior executive management representatives of each Party shall meet at
least once in person to discuss the dispute and use their good faith efforts to resolve the JSC
dispute within [***] days after submission of such dispute to such officers.
2.6.3 If the senior executive management representatives (or their designees) cannot reach
agreement with respect to a JSC dispute within the time period set forth in
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subsection (b) above, the [***] shall have the authority to finally resolve such dispute.
2.6.4 Notwithstanding the terms of subsections 2.6.2 and 2.6.3 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 shall be resolved in accordance with the terms of Section 16.4.
2.7 Project Team. The Parties shall establish a joint project team (the “JPT”) consisting of
an appropriate number of representatives of each Party. Each Party shall designate one of its JPT
members as the project team leader who shall be the primary contact person for the other Party for
matters relating to the development of a Product by such Party. The JPT shall coordinate the
day-to-day activities of the Parties in the performance of the Development Plan and conduct those
activities as directed by the JSC, including preparation of applicable budget expense reporting.
The JPT shall take action by unanimous consent of the Parties, with each Party having a single
vote, irrespective of the number of representatives actually in attendance at a meeting, or by a
written resolution signed by the designated representative of each Party. If the JPT is unable to
reach unanimous consent on a particular matter, such matter shall be submitted to the JSC for
resolution in accordance with Section 2.6. On a quarterly basis, the JPT shall provide a written
report to the JSC summarizing the Parties’ progress with respect to the development of the Products
and any matters directed by the JSC. The JPT shall be disbanded upon the earlier to occur of (a)
anytime following the receipt of the first Marketing Approval of the MT203 Product, at the option
of Micromet, (b) anytime Micromet is no longer actively participating in the development of the
MT203 Product under this Agreement, or (b) the [***] anniversary of the Effective Date.
3. Product Development
3.1 General. Without limiting the Parties’ obligations under this Agreement, the Parties
acknowledge that the ultimate objective of the collaboration is to develop one or more
pharmaceutical products including formulation, packaging and application systems as an MT203
Product or Product to be launched and marketed in the Field in the Territory. The Parties shall
take into consideration this ultimate target when undertaking the development as set out below and
subject to the terms of this Agreement.
3.2 Development Plan.
3.2.1 Promptly following the execution of this Agreement with respect to the MT203 Product,
and the delivery of a written notice pursuant to Section 3.8.1 with respect to any Additional
Product, and pursuant to Section 3.8.2 with respect to any Substitute Product, the JPT shall
prepare for review by the JSC a detailed plan of the research, development and manufacturing
activities to be performed by the Parties with respect to the MT203 Product, and any such
Additional Product or Substitute Product (the “Development Plan”). The Development Plan shall
include an allocation of the responsibility for the performance of the development activities to
one or the other Party and an estimated budget for the activities to be conducted by each Party,
with Micromet being assigned those activities relating primarily to the preclinical development of
such Product and process development and manufacturing of such
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Product for clinical trials, and Nycomed being assigned those activities relating primarily to
the clinical development of such Product, including establishment of a commercial manufacturing
process and commercial manufacturing. Notwithstanding the above, the Development Plan shall in any
event include the activities and allocation of responsibilities described in the outline of the
Development Plan contained in Exhibit C (it being understood that the estimated budget on
Exhibit C is preliminary and subject to change based upon the Parties’ preparation and
review of the Development Plan). The JSC shall promptly review and approve the initial Development
Plan and on a regular basis review and revise the then-current Development Plan (including the
related budget) to reflect the progress achieved and the further development activities to be
undertaken by the Parties in the development of the Product. Any material revisions to the
Development Plan must be approved by the JSC in accordance with Section 2.6, provided that any
modifications to the obligations or expenses of Micromet under the Development Plan shall require
the prior written consent of Micromet not to be unreasonably withheld or delayed regarding any
activity for which Micromet is primarily responsible as described on Exhibit C or any
Development Plan approved by Micromet. Except as otherwise provided in this Agreement, Nycomed
shall control the performance of the activities performed in the Development Plan, and shall at its
discretion designate activities to be performed by Nycomed or by a Third Party.
3.2.2 The Development Plan shall be designed to accomplish the filing of INDs, and BLAs and
the receipt of Marketing Approval in order to optimize the economic potential for the Product in
the Territory, including the proposed study designs for clinical trials and a budget of Development
Expenses to be incurred pursuant to the Development Plan. The Development Plan shall set specific
objectives and timelines for carrying out development activities sufficient in scope and quality to
progress the development of the Product towards Marketing Approval within timelines and using
standards customary in the biopharmaceutical industry for products at a similar stage of
development and with similar market potential. Without limiting the generality of the foregoing,
the Development Plan shall be designed to develop, and to obtain Marketing Approval for, such
Product in all Major Markets.
3.3 Development Expenses. Nycomed shall bear all Development Expenses incurred by the Parties
after the Effective Date, and shall pay to Micromet on or before the first day of each calendar
quarter the amount of Development Expenses budgeted to be incurred by Micromet in such calendar
quarter as set forth in the applicable Development Plan. Nycomed shall pay all such amounts to an
account established by Micromet which is exclusively used for the coverage of the Development
Expenses. Any interest received from the deposited amount on the account shall be credited against
the Development Expenses. Micromet shall provide Nycomed with quarterly reports containing a
detailed account of development activities performed and Micromet’s Development Expenses incurred
during the preceding calendar quarter. The Parties shall work together to reconcile, in a timely
fashion, the Development Expenses set forth in the reports presented by Micromet with Nycomed’s
payments for such quarter. If the Parties determine that such payments exceed Micromet’s reported
Development Expenses, then the amount of such excess shall be credited against the next payment of
Development Expenses by Nycomed hereunder (or, if no such payment is anticipated, refunded by
Micromet to Nycomed within [***] days of such determination). If the Parties determine that
Micromet’s reported Development Expenses exceed the amount paid by Nycomed, then Nycomed shall pay
the excess amount to Micromet within [***] days of such determination but no later than the next
quarterly advance payment made by Nycomed under this Section 3.3. All
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such Development Expenses shall be paid to the extent made or incurred in conjunction with an
approved budget line item in the Development Plan as approved and revised from time to time by the
JSC as set forth below. The JSC shall monitor and review on a quarterly basis the actual expenses
incurred by the Parties in conducting development activities under the Development Plan and each
Party shall promptly notify the JSC if it reasonably expects that its Development Expenses during
any calendar period shall exceed by [***] percent [***] the then-current budgeted amount for such
period. In such event, the JSC shall in good faith consider and review a corresponding amendment
to either the applicable budget or the scope of development activities to be performed consistent
with the Parties’ obligations under this Agreement.
3.4 Right of Negotiation for [***] . At any time prior to the initiation of the [***] with a
Product by Nycomed, upon written request of Micromet, the Parties shall [***] whether and under
what terms Micromet may [***] . Such [***] may include the [***] for the clinical development,
and an [***] to reflect the [***] borne by the Parties as a result of such [***] , and such other
terms that the Parties may deem appropriate under the circumstances. For clarity, the Parties agree
that Micromet’s rights with respect to [***] are limited to the [***] mentioned in this Section
3.4 unless the Parties agree otherwise in their sole discretion.
3.5 Diligence in Development.
3.5.1 Micromet shall use Commercially Reasonable Efforts to perform the activities assigned to
it in the Development Plan. Micromet shall deliver certain data generated by Micromet to be
included in the “CMC Part” of the BLA. All efforts of Micromet’s Affiliates, sublicensees and Third
Party contractors shall be considered efforts of Micromet for the purpose of determining Micromet’s
compliance with its obligations under this Section 3.5.1.
3.5.2 Nycomed shall use Commercially Reasonable Efforts to develop each Product in one or more
Indications with the objective of maximizing the overall commercial potential of such Product and
to perform the activities assigned to it in the Development Plan. All efforts of Nycomed’s
Affiliates, sublicensees and Third Party contractors shall be considered efforts of Nycomed for the
purpose of determining Nycomed’s compliance with its obligations under this Section 3.5.2.
3.6 Selection of Indications. The Parties agree that each Product may be effective for the
treatment of Indications in the field of [***] diseases, but not limited to, rheumatoid arthritis,
COPD, asthma, psoriasis, multiple sclerosis [***] diseases, and that it is in the best interest of
both Parties to develop such Product broadly in multiple Indications subject to reasonable
commercial and technical considerations. The Parties further agree to pursue a development
strategy that initially focuses on the clinical development of the MT203 Product in [***] , and
subject to reasonable commercial and technical considerations to expand the Development Plan to
include additional Indications following the achievement of clinical proof of principle of such
Product in [***] in a clinical trial. To that end, the Parties agree to include in the
Development Plan the performance of development activities designed to establish in preclinical
models proof of concept of the effectiveness of such Product in two other Indications. Such
development activities shall be performed in parallel with the development of the MT203 Product in
[***] . If the Parties achieve such preclinical proof of concept with one or more such additional
Indications, the Development Plan shall be amended to include the development of the
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11
MT203 Product in such additional Indications, subject to reasonable commercial and technical
considerations, promptly after the achievement of proof of principle of such Product [***] in a
clinical trial.
3.7 Records.
3.7.1 Micromet Records. All research, process development and preclinical work conducted by
or on behalf of Micromet under the Development Plan shall be completely and accurately recorded, in
sufficient detail and in good scientific manner, in separate laboratory notebooks in accordance
with Applicable Law distinct from other work being conducted by Micromet.
3.7.2 Nycomed Records. All development work for all Products performed by or on behalf of
Nycomed shall be completely and accurately recorded, in sufficient detail and in good scientific
manner, in separate laboratory notebooks distinct from other work being conducted. Nycomed shall
also retain all clinical trial records required by Applicable Law to be maintained in connection
with the development of all Products.
3.8 Additional Products.
3.8.1 Nycomed shall have the right at any time during the Term to initiate development of a
Product in addition to the MT203 Product as an “Additional Product” under this Agreement upon prior
written notice to Micromet other than Substitute Products described below. For the avoidance of
doubt, the terms and conditions of this Agreement applicable to Products (other than those
specifically limited to the MT203 Product) shall apply to such Additional Product. The development
of the Product for an Indication following a Clinical Failure and discontinuance of development for
another Indication shall not be deemed an Additional Product but rather a Substitute Product as
defined below.
3.8.2 Nycomed shall have the right at any time during the Term to initiate development of a
Product other than the MT203 Product as replacement Product (a “Substitute Product”) under this
Agreement upon prior written notice to Micromet in the event of a Clinical Failure of the MT203
Product and discontinuance of development of such Product by Nycomed. For the avoidance of doubt,
the terms and conditions of this Agreement applicable to Products (other than those specifically
limited to the MT203 Product) shall apply to such Substitute Product; provided, however, that
Nycomed shall not be obligated to pay Micromet upon the achievement of any milestone event
described in Exhibit E for such Substitute Product for which Nycomed previously paid
Micromet in respect of the MT203 Product.
3.9 Product Manufacture. As between the Parties, Micromet shall be responsible for, and shall
use Commercially Reasonable Effort to, manufacture of the MT203 Product for clinical trials other
than Phase 3 Trials for the Territory as described on Exhibit C and to be set forth in the
Development Plan, including manufacturing of the finished Product, ingredients thereof and delivery
systems therefor, including test method development and stability testing, formulation, process
development, manufacturing scale-up, quality assurance/quality control development, quality control
testing, packaging, release and regulatory activities related to all of the foregoing (it being
understood that the supply and availability of a Product shall depend in
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12
part upon the selection and availability of Third Party suppliers). Except as described in
the foregoing, Nycomed shall be responsible for, and shall use Commercially Reasonable Efforts to,
manufacture the Products prior to and following Marketing Approval pursuant to Article 4, either
directly or through Third Parties (it being understood that the supply and availability of a
Product shall depend in part upon the selection and availability of Third Party suppliers). In
addition, Micromet and Nycomed shall agree and describe in the Development Plan the appropriate
timeframe and activities that provide for the transfer of the applicable manufacturing processes
for the MT203 Product to a Third Party manufacturer designated by Nycomed.
4. Product Commercialization
4.1 General. As between the Parties, Nycomed shall be solely responsible for the
Commercialization of the Products in the Territory during the Term. Nycomed shall use Commercially
Reasonable Efforts to Commercialize the Products, either directly or through Third Parties (it
being understood that the supply and availability of a Product shall depend in part upon the
selection and availability of Third Party suppliers).
4.2 Diligence in Commercialization. Nycomed shall, subject to reasonable commercial
considerations in such country, launch the Products within [***] months after receiving Marketing
Approval in any country in the Territory, and thereafter shall use Commercially Reasonable Efforts
to Commercialize the Products in each such country.
4.3 Branding, Trademarks, Trade Dress, and Logos. Nycomed shall solely own, and shall be
solely responsible for selecting, the trademark used to identify a Product that shall be
Commercialized in the Territory pursuant to this Agreement. Nycomed shall oversee the filing,
prosecution and maintenance of all trademark registrations for a Product in the Territory. Nycomed
shall be responsible for the payment of any and all costs relating to filing, prosecution, and
maintenance of the trademarks for a Product in the Territory. Nycomed shall have sole
responsibility for, and shall be sole owner of, all trade dress, logos, slogans, and designs used
on and in connection with a Product in the Territory.
5. Regulatory Matters
5.1 Regulatory Filings; Inspections. Subject to Nycomed’s obligation to Commercialize the
Products pursuant to Section 4, Nycomed shall be responsible for the preparation, filing,
prosecution and maintenance of any Regulatory Filings for the Products. Micromet shall assist
Nycomed, as reasonably necessary, in the preparation of Regulatory Filings, including providing
necessary documents or other materials required by Applicable Law, all as provided for in the
Development Plan (including any applicable timeframes) and in a format and standard reasonably
agreed by the Parties, in each case at Nycomed’s expense. Nycomed shall promptly notify Micromet in
writing and in advance of any meeting with or inspection by any Regulatory Authority relating to a
Product. At Micromet’s option, Micromet may have an employee or Third Party consultant participate
in such meeting or inspection as an observer.
5.2 Regulatory Approvals; Adverse Drug Experiences. Nycomed shall be the holder of all
marketing authorizations for the Products and shall be responsible for obtaining and
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13
maintaining any Marketing Approvals and other regulatory approvals required for the
Commercialization of the Products in the Territory, including communicating and preparing and
filing all reports (including without limitation adverse drug experience reports) and the
application for Marketing Approval with the applicable regulatory authorities. Nycomed shall
comply with the standard of care in performing such activities reasonable and customary to the
pharmaceutical industry and in compliance with all Applicable Law. To the extent either Party
receives any information regarding adverse drug experiences related to the use of a Product, such
Party shall promptly provide the other Party with such information as is required under Applicable
Laws. Prior to the first commercial launch of a Product, the Parties shall agree on standard
operating procedures implementing the requirements under Applicable Law regarding adverse event
reporting, which procedures, as may be amended from time to time upon mutual agreement of the
Parties, shall be incorporated in this Agreement by reference. The Parties acknowledge that the
receipt of Marketing Approvals depends on, in part, the availability and sufficiency of efficacy
and safety data for a Product.
5.3 Communications with Regulatory Authorities. Nycomed shall be solely responsible for any
communications with the regulatory authorities occurring or required in connection with obtaining
or maintaining any Marketing Approvals for a Product. Nycomed shall promptly provide Micromet with
copies of all written or electronic correspondence received from regulatory authorities relating to
a Product, and shall provide Micromet with a reasonable opportunity to provide comments on any
responses by Nycomed to such regulatory authorities. Upon the reasonable request of Nycomed,
Micromet shall assist Nycomed to address requests from and communications to regulatory authorities
applicable to Micromet’s activities conducted with respect to a Product, including data and
information held by Micromet.
5.4 Regulatory Records. Each Party shall maintain, or cause to be maintained, for at least
[***] years and for at least [***] years after the termination of this Agreement, or for such
longer period as may be required by Applicable Law, complete and accurate records of its respective
development activities with respect to a Product in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes, which fully and properly reflect all work done and
results achieved in the performance of its respective development activities. Each Party shall have
the right, during normal business hours and upon reasonable notice, to inspect and copy any such
records, except to the extent that a Party reasonably determines that such records contain
Confidential Information that is not licensed to the other Party, or to which the other Party does
not otherwise have a right hereunder.
6. Intellectual Property
6.1 License Grants by Micromet.
6.1.1 Subject to the terms and conditions set forth in this Agreement, Micromet grants to
Nycomed an exclusive, royalty-bearing license, with the right to grant sublicenses in accordance
with Section 6.2, to the Licensed Technology (other than the Sublicensed Patents and the
Sublicensed Know-How), to conduct research and development, make, have made, use, Commercialize,
and import the Products in the Field in the Territory.
6.1.2 Subject to the terms and conditions set forth in this Agreement and the
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14
applicable Upstream Agreements, Micromet grants to Nycomed an exclusive, royalty-bearing
sublicense, with the right to grant further sublicenses in accordance with Section 6.2, under the
rights and licenses granted to Micromet in the Upstream Agreements with respect to the Sublicensed
Technology, to research, develop, Commercialize, make, have made, use, offer for sale, sell, and
import the Products in the Field in the Territory. Nycomed acknowledges and agrees that it has
received a copy of each Upstream Agreement, and that the rights, licenses and sublicenses granted
by Micromet to Nycomed in this Agreement are subject to the terms of the Upstream Agreements.
Subject to section 6.8.2, Nycomed covenants not to take or fail to take any action that violates
the terms of such Upstream Agreements applicable to sublicensees, or that would cause Micromet to
be in breach of any of the terms of the Upstream Agreements.
6.2 Sublicensing by Nycomed.
6.2.1 General. Subject to the terms and conditions of this Agreement, Nycomed shall have the
right to sublicense to a Third Party any rights granted under Section 6.1.1 or 6.1.2 with respect
to a particular Product, through written sublicense agreements for (i) [***] to an entity having
[***] and [***] at least [***] to [***] for the [***] or
[***] of a Product, as [***] to the [***] and [***] under the
[***] for [***] and (ii) other [***] in the [***] in its
[***]. In connection with the grant of any such sublicense, Nycomed shall remain responsible
to Micromet for the performance of Nycomed’s obligations under this Agreement.
6.2.2 SCA Patent
Option. If Nycomed desires to initiate the development of a Product
comprising a [***], Nycomed shall provide written notice thereof to Micromet. Upon
receipt of such notice, the definition of “Licensed Patents” shall be expanded to include the
Patents listed in Exhibit F, by amending Exhibit A-2 to include such Patents, and
Nycomed shall be granted a license or sublicense, as applicable, under the SCA Patents pursuant to
the terms of Section 6.1.1 or 6.1.2, as applicable, and the other terms of this Agreement. Any
license or sublicense under this Agreement to the [***] shall be subject to the terms of the
applicable Upstream Agreements, including the exclusion of the research, development, manufacture,
use, or sale of any product described in Exhibit I.
6.3 License Grant by Nycomed. Subject to the terms and conditions set forth in this
Agreement, Nycomed grants to Micromet a non-exclusive, royalty-free license, under any applicable
Patents or Know-How Controlled by Nycomed, to conduct those development responsibilities assigned
to Micromet under the Development Plan. Such license shall be sublicensable solely to
subcontractors approved by the JSC, such approval not be unreasonably withheld.
6.4 Reservation of Rights. Nycomed hereby covenants and agrees not to use any Licensed
Technology, nor cause or authorize any Affiliate or Third Party to use any Licensed Technology,
other than as expressly permitted in this Agreement. Except for the rights specifically granted in
this Agreement and subject to Section 6.9, Micromet reserves all rights to the Licensed Technology
and reserves the right to utilize or allow Third Parties to utilize the Licensed Technology
consistent with the terms of this Agreement. In addition, Micromet reserves all rights in the
Licensed Technology to the extent necessary for it to conduct those
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15
development responsibilities assigned to it under the Development Plan. No implied licenses
are granted under this Agreement. Notwithstanding anything in this Agreement to the contrary, no
license or right granted by Micromet under this Agreement, including Sections 6.1.1, 6.1.2 and
6.5.2, shall convey or grant to Nycomed any right, either directly or through a Third Party, to
research, develop, use, manufacture or Commercialize any product containing or comprising a BITE
molecule or fragment thereof.
6.5 Ownership of Collaboration Technology; Licenses to Nycomed Collaboration Technology.
6.5.1 Subject to the licenses granted to Nycomed in this Agreement, Micromet shall own all
right, title, and interest in and to the Micromet Collaboration Technology. Subject to the
licenses granted to Micromet in this Agreement, Nycomed shall own all right, title, and interest in
and to any Nycomed Collaboration Technology. Subject to the licenses granted to Nycomed in this
Agreement and the terms of this Agreement, Micromet and Nycomed shall each own an undivided equal
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 Joint
Collaboration Technology. Each Party shall disclose to the other Party in writing, and shall cause
its Affiliates, agents and independent contractors to so disclose to it, the development, making,
conception or reduction to practice of any Collaboration Technology owned by it pursuant to this
Section 6.5.1 in reports provided to the JPT or the JSC in the course of the performance of this
Agreement. Each Party shall take all necessary and proper acts, and shall cause its employees,
Affiliates, sublicensees, contractors, and consultants to take such necessary and proper acts, to
effectuate the ownership provisions provided in this Section 6.5.1.
6.5.2 Each Party hereby grants, and agrees to grant, to the other Party a worldwide,
perpetual, non-exclusive, royalty free license (with the right to grant and authorize the further
grant of sublicenses), under any Patent or Know-How included within the Nycomed Collaboration
Technology and Micromet Collaboration Technology, respectively, to research, to have researched, to
develop, to have developed, to Commercialize, to import and to have imported pharmaceutical
products other than Products subject to the rights and licenses granted to Nycomed under this
Agreement and the mutual covenant in Section 6.9. Each of the Parties may grant sublicenses to
Third Parties under the foregoing license only for products developed or commercialized by such
Party or with a Third Party. Each Party shall provide the other Party with written notice promptly
following the grant of any such sublicense.
6.6 Prosecution and Maintenance of Patents.
6.6.1 As between the Parties, Micromet shall be responsible for the filing, prosecution and
maintenance of the Patents within the Licensed Technology, Micromet Collaboration Technology and
Joint Collaboration Technology. Nycomed shall reimburse Micromet for Micromet’s reasonable and
documented external costs incurred in connection with the filing, prosecution and maintenance of
the foregoing except for the Patents listed on Exhibit A-2; provided, however, that
Nycomed’s reimbursement obligation shall be limited to [***] percent [***] of any costs
associated with the Joint Collaboration Technology and the Micromet Collaboration Technology. Upon
receipt of written notice of the filing of a patent application within the Micromet Collaboration
Technology, Nycomed shall have the option to decline to pay
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16
for the filing, prosecution and maintenance of such patent by written notice to Micromet.
Upon receipt of such notice by Micromet, such patent shall be excluded from the licenses granted
under this Agreement. Nycomed shall be responsible, at its sole cost, for the filing, prosecution
and maintenance of the Patents within the Nycomed Collaboration Technology.
6.6.2 With respect to each of the Patents within the Licensed Technology listed in Exhibit
A-1, Micromet Collaboration Technology and Joint Collaboration Technology, Micromet shall give
Nycomed an opportunity to review and comment on the text of the patent application, office action
(including restriction requirements) and substantive correspondence with the applicable patent
office before filing and shall supply Nycomed with a copy of each patent application as filed,
together with its notice of filing date and serial number. Micromet shall consider and incorporate
in good faith the requests and suggestions of Nycomed with respect to the foregoing.
6.6.3 Micromet shall keep Nycomed informed of progress with regard to the preparation, filing,
prosecution and maintenance of the Patents within the Licensed Technology listed in Exhibit
A-1, Micromet Collaboration Technology and Joint Collaboration Technology. Nycomed shall
cooperate with Micromet, execute all lawful papers and instruments and make all rightful oaths and
declarations as may be necessary in the preparation, prosecution and maintenance of all patents and
other filings referred to in this Section 6.6.
6.6.4 If Micromet, in its sole discretion, decides to abandon the preparation, filing,
prosecution or maintenance of any Patent within the Licensed Technology listed in Exhibit
A-1, Micromet Collaboration Technology or Joint Collaboration Technology, then Micromet shall
notify Nycomed in writing thereof and following the date of such notice (a) Nycomed shall, at its
option, be responsible for and shall control, [***] , the preparation, filing, prosecution and
maintenance of such patents and patent applications, and (b) if Nycomed does not assume such
control, then Micromet may abandon such Patent.
6.7 Enforcement of Patents.
6.7.1 Notice. If either Party learns that a Third Party is infringing or allegedly infringing
any Patent within the Licensed Technology or Joint Collaboration Technology, it shall promptly
notify the other Party thereof including available evidence of infringement. The Parties shall
cooperate and use reasonable efforts to stop such alleged infringement without litigation.
6.7.2 Enforcement Actions for Licensed Technology.
(a) As between the Parties, Micromet shall have the first right (but not the obligation) to
take the appropriate steps to remove the infringement or alleged infringement of Licensed
Technology or Joint 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.
(b) If Micromet fails to bring an action or proceeding to remove the infringement of the
Licensed Technology or Joint Collaboration Technology with respect to the research, development,
use, manufacture, filing for Marketing Approval of a product constituted through an “ANDA”
registration in the U.S., marketing or sale of a product potentially
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17
competitive with a Product (a “Product Infringement Claim”) within [***] days of a Party
giving notice to the other Party under Section 6.7.1 (or [***] days of a Party giving notice to
the other Party under Section 6.7.1 if the infringement is through an “ANDA” registration in the
U.S.), then (subject to the terms of the applicable Upstream Agreement with respect to the
Sublicensed Patents), Nycomed shall have the right (but not the obligation) to bring any such
action or proceeding by counsel of its own choice for any Licensed Patent listed on Exhibit
A-1 and Joint Collaboration Technology, and Micromet shall have the right, at its own expense,
to be represented in any such action by counsel of its own choice. To the extent that any alleged
infringer claims invalidity or non-enforceability of a Patent within Licensed Technology or Joint
Collaboration Technology as a defense, Micromet shall have the right to assume control of the
litigation with respect to such defense. The Parties mutually shall issue the necessary power of
attorneys for each other to undertake the steps described in subsection (a) above and in this
subsection (b).
6.7.3 Enforcement Actions for Nycomed Collaboration Technology. Nycomed shall have the sole
right (but not the obligation) to take the appropriate steps to remove the infringement or alleged
infringement of Nycomed 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 shall have the right, [***] , to be represented in any such action by counsel of its own
choice.
6.7.4 Enforcement Actions for Micromet Collaboration Technology. Micromet shall have the sole
right (but not the obligation) to take the appropriate steps to remove the infringement or alleged
infringement of Micromet 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.
Nycomed shall have the right, [***] , to be represented in any such action by counsel of its own
choice.
6.7.5 Cooperation; Damages.
(a) If one Party brings any action or proceeding described in this Section 6.7, 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 shall 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.
(b) Any settlements, damages or other monetary awards (the “Recovery”) recovered pursuant to a
Product Infringement Claim shall be allocated first to the costs and expenses of the Party bringing
suit, and second to the costs and expenses (if any) of the other Party, with any remaining amounts
(if any) to be allocated as follows:
(i) If Nycomed pursued the Product Infringement Claim, the Recovery shall be [***] .
(ii) If Micromet pursued the Product Infringement Claim, the Recovery shall be [***] , and
[***] , and Micromet shall [***] after deducting the [***]
pursuant to [***] .
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18
6.8 Consequences of Patent Challenge.
6.8.1 Termination on Patent Challenge. Micromet shall be permitted to terminate this
Agreement by written notice effective upon receipt if Nycomed or its Affiliates directly, or
indirectly through assistance granted to a Third Party, commence any interference or opposition
proceeding, challenge the validity or enforceability of, or oppose any extension of or the grant of
a supplementary protection certificate with respect to, any Patent within the Licensed Technology
(other than the Sublicensed Patents and the Sublicensed Know-How) (each such action a “Patent
Challenge”).
6.8.2 Patent Challenge on Sublicensed Patents. Before commencing any interference or
opposition proceeding, challenging the validity or enforceability of, or opposing any extension of
or the grant of a supplementary protection certificate with respect to any Sublicensed Patents,
Nycomed shall duly consult with Micromet and consider any comments from Micromet in that respect.
In particular, Nycomed shall consider consequences of Micromet’s contractual relationships in
relation to any such Sublicensed Patents. In the event that Nycomed either directly or indirectly
commences any such proceeding for any Patent covered by an Upstream Agreement over the objections
of Micromet, then Micromet may immediately terminate the license to Nycomed under Section 6.1 as to
any Sublicensed Technology under such applicable Upstream Agreement, or to the extent permitted
under the applicable Upstream Agreement, with respect to the Sublicensed Patent that is the subject
of such Patent Challenge.
6.8.3 Sublicensees. Nycomed shall include provisions in all agreements granting sublicenses
of Nycomed’s rights hereunder providing that if the sublicensee or its Affiliates undertake a
Patent Challenge with respect to any Patent within the Licensed Technology under which the
sublicensee is sublicensed, Nycomed shall be permitted to terminate such sublicense agreement. If
a sublicensee of Nycomed (or an Affiliate of such sublicensee) undertakes a Patent Challenge of any
such Patent under which such sublicensee is sublicensed, then Nycomed upon receipt of notice from
Micromet of such Patent Challenge shall terminate the applicable sublicense agreement. If Nycomed
fails to so terminate such sublicense agreement, Micromet may terminate this Agreement.
6.9 Parallel Programs.
6.9.1 Permitted Products.
(a) During the Term, neither Party, either on its own, through an Affiliate or in
collaboration with a Third Party, shall [***] or [***] , in the Territory an [***] ; provided,
however, the foregoing restriction shall not apply to any Permitted Product (defined below) of a
Third Party that [***] or [***] with other [***] all or [***] of
the [***] or [***] [***] % [***] the [***] of a [***] in [***]
with a [***] in
[***]. For purposes of this Section 6.9, a “Permitted Product” means any [***] then being
developed or commercialized by [***] . In the [***] of any [***] in [***] of [***]
where the
[***] a [***], then [***] [***] the
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19
[***] of
such [***]: [***] . Notwithstanding the above, no rights to
Collaboration Technology and Licensed Technology are or may be granted or exploited in connection
with the research, development or Commercialization of a Permitted Product.
(b) Notwithstanding subsection (a) above, Nycomed shall have the right to research, develop
and Commercialize [***] that is based solely on patents and know-how generated by Nycomed
(“Independent Product”); provided, however, that Nycomed shall inform Micromet if and when it
initates the research, development or Commercialization of such product; and provided, further,
that Micromet shall have the right [***] to the extent permitted by applicable laws upon [***]
days prior written notice at any time after the [***] . For the avoidance of doubt, Nycomed has
not been granted any rights under the Licensed Technology, and shall not use any Licensed
Technology, for or in connection with the research, development or Commercialization of an
Independent Product.
6.9.2
In the event that, following the Effective Date, Nycomed or its Affiliates [***], as
part of a [***] of a [***], a [***] or [***] that [***] a [***],
then [***] shall upon the [***] the [***] (i) [***] ; or (ii) [***]
within the [***] [***] the [***] of
[***], subject to [***] it [***] understood that such [***] may be [***] other [***],
where such [***]; or (iii) [***] into a
[***] to a [***] such
[***] and [***] of its [***] of the
[***] ; [***] shall not [***] of such [***] as a part of a
[***] does not [***] . In the event that, [***] or its
[***], as part of a [***] of a [***], a person or
entity that [***] , then [***] may [***] following the closing of
such [***].
6.10 Third Party Patent Rights. Upon the request of Nycomed, Micromet shall use reasonable
efforts to search, monitor, collate and evaluate Third Party Patent rights that may be potentially
related to the MT203 Product during a period not to exceed [***] months following the Effective
Date. Nycomed shall reimburse Micromet for its internal FTE Costs and external costs of conducting
such activities. Any Third Party Patent rights which in Micromet’s good faith evaluation
potentially related to the MT203 Product shall be brought to Nycomed’s attention without
unreasonable delay. Micromet shall reasonably cooperate with Nycomed upon request regarding the
review and analysis of such Third Party Patent rights. To the extent that the Parties reasonable
determine to acquire any rights in and to such Third Party Patents, the Parties shall discuss in
good faith the license or acquisition of such rights in accordance with Section 7.3.3.
7. Fees and Payments
7.1 Initial License Fee. On the Effective Date, Nycomed shall pay to Micromet a
non-refundable, non-creditable initial license fee in the amount of five million Euros
(€5,000,000).
7.2 Development Milestones. Nycomed shall pay Micromet each of the non-
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20
refundable, non-creditable payments in the amounts set forth on Exhibit E attached
hereto within [***] days after the first occurrence of the corresponding event described on such
exhibit with respect to a Product.
7.3 Royalties.
7.3.1 Royalty Rates. Subject to the adjustments provided for in Section 7.3.3, Nycomed shall
pay to Micromet a royalty equal to:
(a) [***] percent [***] of worldwide Net Sales of a Product for that portion of the total
amount of aggregate worldwide Net Sales of all Products in any calendar year that is less than or
equal to [***] ;
(b) [***] percent [***] of worldwide Net Sales of a Product for that portion of the total
amount of aggregate worldwide Net Sales of all Product in any calendar year that is greater than
[***] but less than or equal to [***] ;
(c) [***] percent [***] of worldwide Net Sales of a Product for that portion of the total
amount of aggregate worldwide Net Sales of all Products in any calendar year that is greater than
[***] but less than or equal to [***] ; and
(d) [***] percent [***] of worldwide Net Sales of a Product for that portion of the total
amount of aggregate worldwide Net Sales of all Products in any calendar year that is greater than
[***] .
7.3.2 Aggregation of Net Sales; Royalty Term; Bioequivalent Products.
(a) The Parties agree and acknowledge that the determination of aggregate worldwide Net Sales
for the tiers described in Section 7.3.1 shall be based upon the Net Sales of all Products then
accrued during each applicable calendar year (or portion thereof) and the determination of a
particular royalty rate then-applicable to a particular sale of a Product shall be made as of the
date such sale was invoiced.
(b) Royalties due under the preceding Section 7.3.1 shall commence upon first commercial sale
of a Product in a particular country in the Territory and shall expire on a country-by-country
basis upon the later of: (i) the [***] of the [***] within the [***] (other than
[***]) containing a [***] in such [***] from the [***] of a [***].
(c)
With respect to any country in the Territory, in the event that (i) [***]
within the [***] (other than [***] in such [***] have [***]
and (ii) the [***] of a [***] in such [***]
of the [***] of such [***] in the [***] for which the [***] is then
[***] in such [***], then the [***] in such [***] shall be [***]
in lieu of the [***] under [***] shall no longer be [***]
to any [***] under [***] in such [***].
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7.3.3 Adjustment to Royalties. If (a) a Patent or Patents of a Third Party should exist in
any country during the Term that cover the research, development, use, manufacture, or sale of a
Product, which would prevent Nycomed or any Affiliate from undertaking any of the above-mentioned
activities without obtaining a royalty-bearing license from such Third Party under such Patent or
Patents, and (b) the total royalties payable by Nycomed under all such licenses including the
royalties payable under the Upstream Agreements with respect to sales of such Product in a
particular country exceeds [***] percent [***] of Net Sales, then Nycomed shall be entitled to
credit [***] against the royalty payments due to Micromet upon sales of such Product in the
applicable country; provided that such credit shall in no event cause the royalty payable to
Micromet as applicable to a particular country hereunder to be reduced to below [***] percent
[***] . Micromet shall reasonably cooperate with Nycomed upon request regarding whether Micromet
should obtain directly a license to any intellectual property described in this Section 7.3.3. If
agreed by the Parties, Micromet shall license such intellectual property from a Third Party for the
benefit of Nycomed (and with Nycomed bearing all such associated costs subject to this Section
7.3.3) and thereupon Exhibit D shall be automatically amended to include any corresponding
license agreement as an Upstream Agreement.
7.4 Payments under Upstream Agreements. [***] shall pay to [***]
any and all [***]
and other [***] to the opposite [***] of the [***]
that may become due during the [***] of all [***]. Any such payment shall made into an [***]
for the specific purpose of [***] and making such
payments to the opposite parties of the [***]. Upon receipt of each such payment
from [***] shall make a corresponding payment to the opposite party in accordance with
the terms of the applicable [***]. The Parties shall agree on a process, [***] shall receive the
payment from [***] in time to make the [***] in a timely fashion. [***] due
to [***] under the [***] shall be due and payable at least [***]
before any [***] are owed [***] under the [***].
For purposes of this Agreement, “Business Days” mean dates that banks are open in Germany.
8. Payment Terms
8.1 Payment Method. All amounts due hereunder shall be paid in Euros by wire transfer in
immediately available funds to an account designated by Micromet. Any payments or portions thereof
due hereunder which are not paid on the date such payments are due under this Agreement shall bear
interest at the lower of (i) [***] % over the [***] 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; provided that Nycomed shall not be obligated to pay interest on any amount that it
disputes in good faith are not due and payable while such dispute is pending, further provided that
such interest shall be due and payable if any such dispute is resolved in favor of Micromet.
8.2 Payment Schedules; Reports. The milestone payments due pursuant to Section 7.2 are due
and payable within [***] days after the achievement of the applicable milestone
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22
event set forth in Exhibit E. Royalty payments due pursuant to Section 7.3 are due
and payable within [***] days of the end of each calendar quarter during the Term during which
there were Net Sales of any Product in the Territory. Nycomed shall accompany each payment of
royalties under this Agreement with a report containing a detailed and itemized calculation of Net
Sales of all Products in the Territory during the preceding calendar quarter, including a
description of the dates and territories in which any Product sales were made.
8.3 Currency Conversion. For any currency conversion required in determining the amount of
royalties due, such conversion shall be made at the prevailing commercial rate of exchange for
purchasing the currency into which an amount is to be converted as set forth in the Frankfurter
Allgemeine Zeitung on the day that is the last business day of the applicable quarterly period for
any royalty payments made pursuant to this Agreement. For purposes of determining the amount of
royalties due, the amount of Net Sales in any foreign currency shall be computed by converting such
amount into Euros as provided in this Section 8.3. All payments due under this Agreement shall be
paid in full without deduction for any withholding or value added tax.
8.4 Records Retention; Audit.
8.4.1 Record Retention. Each Party shall maintain complete and accurate books, records and
accounts used for the determination of (a) any Development Expenses that the other Party is
required to reimburse under this Agreement and (b) Net Sales, in sufficient detail to confirm the
accuracy of any payments required under this Agreement, which books, records and accounts shall be
retained by such Party until [***] years after the end of the period to which such books, records
and accounts pertain.
8.4.2 Audit. Each Party shall 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 Development
Expenses or Net Sales for any calendar quarter ending not more than [***] months prior to the date
of such request; provided, however, that no Party shall have the right to conduct more than one
such audit in any [***] -month period. The accounting firm shall 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 shall bear all
costs of such audit, unless the audit reveals any discrepancy in the audited Party’s favor of more
than [***] %, in which case the audited Party shall bear the cost of the audit. The results of
such accounting firm shall be final, absent manifest error.
8.4.3 Payment of Additional Amounts. If, based on the results of any audit, additional
payments are owed to Micromet under this Agreement, then Nycomed shall make such additional
payments promptly after the accounting firm’s written report is delivered to both Parties. If,
based on the results of any audit, royalty or development payments made by Nycomed hereunder
exceeded payments indicated by the audit as being due thereunder, such excess shall be credited
against future amounts owed by Nycomed under this Agreement.
8.4.4 Confidentiality. Each Party shall treat all information subject to review
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23
under this Section 8.4 in accordance with the provisions of Section 9 and shall 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.
9. Confidentiality
9.1 Definition. During the Term and subject to the terms and conditions of this Agreement, a
Party (the “Disclosing Party”) may communicate to the other Party (the “Receiving Party”)
information in connection with this Agreement or the performance of its obligations under this
Agreement, including, without limitation, any information regarding Improvements, reports provided
pursuant to this Agreement, scientific and manufacturing information and plans, marketing and
business plans, and financial and personnel matters relating to a Party or its present or future
products, sales, suppliers, customers, employees, investors or business (collectively,
“Confidential Information”). Subject to Section 9.2, “Confidential Information” shall also include
any information disclosed prior to the Effective Date pursuant to that certain Confidentiality
Agreement between the Parties dated February 7, 2007.
9.2 Exclusions.
9.2.1 Notwithstanding the foregoing, any information of a Party shall not be deemed
Confidential Information with respect to the 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 Disclosing 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 the Receiving Party or the Receiving Party’s breach of its
obligations under this Article 9;
(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 Disclosing Party 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 of the Disclosing Party.
9.3 Disclosure and Use Restriction. Except as expressly provided herein, the Parties agree
that, during the Term and for ten (10) years thereafter, each Party and its Affiliates and
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24
sublicensees shall keep completely confidential and shall not publish or otherwise disclose
any Confidential Information of the other Party, its Affiliates or sublicensees. Neither Party
shall use any Confidential Information of the other Party without such other Party’s consent,
except as expressly permitted by this Agreement.
9.4 Authorized Disclosure. Each Party may use and disclose Confidential Information of the
other Party to the extent that such use and disclosure is:
9.4.1 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 shall
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 shall be
limited to that information which is legally required to be disclosed in response to such court or
governmental order;
9.4.2 otherwise required by applicable laws or regulations, including the rules of any
applicable securities exchange; provided, however, that the Disclosing Party shall provide such
other Party with notice of such disclosure in advance thereof to the extent practicable;
9.4.3 made by such Party to the regulatory authorities as required in connection with any
filing of INDs, BLAs, marketing approval applications, or similar applications or requests for
regulatory approvals; provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information;
9.4.4 made by such Party, in connection with the performance of this Agreement, on a
need-to-know basis 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 9;
9.4.5 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; or existing or potential investors, venture capital firms or other financial
institutions or investors for purposes of obtaining financing, 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 9; or
9.4.6 made in a patent application filed in conformance with this Agreement.
9.5 Terms of Agreement to be Maintained in Confidence. Subject to the provisions of this
Section 9, the Parties agree that the terms of this Agreement are deemed Confidential Information
of both Parties and shall be subject to the restrictions on use and disclosure set forth herein
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25
9.6 Replacement of existing CDA. This Agreement shall replace the Confidential Non Disclosure
Agreement entered into between Parties on February 7, 2007. Any Confidential Information provided
under that agreement shall be deemed provided under this Agreement.
10. Public Communications
10.1 General Provisions. The Parties shall cooperate with respect to the timing and content
of communications with the public regarding the development and marketing of a Product, under the
terms to be set forth in the Development Plan and subject to the provisions of this Section 10.
10.2 Use of Name. Neither Party shall make public use of the other Party’s name except (a) as
required by applicable law or regulation, or (b) otherwise as agreed in writing by such other
Party.
10.3 Press Releases.
10.3.1 The Parties (or their Affiliates) shall issue a joint press release regarding the
execution of this Agreement substantially in the form attached in Exhibit H. For
subsequent press releases relating to this Agreement or the Parties’ relationship hereunder, each
Party (or its Affiliate) shall use reasonable efforts to submit to the other Party a draft of such
press release for review and comment by the other Party at least [***] Business Days prior to the
date on which such Party plans to issue such press release (“Proposed Disclosure”), and shall
review and consider in good faith any comments provided by the other Party. If a Party is unable
to comply with the foregoing [***] -Business Day notice requirement because of a legal obligation
or stock exchange requirement to make more rapid disclosure, such Party shall not be in breach of
this Agreement but shall 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
press release. For the avoidance of doubt, Micromet or its Affiliate) may disclose the receipt and
amount of any milestone payment made by Nycomed under this Agreement in accordance with the
provisions of this Section 10.3.1.
10.3.2 A Party may publicly disclose without regard to the preceding requirements of this
Section 10.3 information that was previously disclosed in a Proposed Disclosure that was in
compliance with such requirements.
10.4 Publications. At least [***] days prior to submission of any material related to the
research or development activities hereunder for publication or presentation, the submitting Party
shall provide to the other Party a draft of such material for its review and comment. The
receiving Party shall provide any comments to the submitting Party within [***] days of receipt of
such materials. No publication or presentation with respect to the research or development
activities hereunder shall be made unless and until the other Party’s comments on the proposed
publication or presentation have been addressed and changes have been agreed upon 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 shall withhold material from
submission for publication or presentation for the time reasonably required for the filing and
until expiry of the priority year relating to that patent application or the taking of such
measures
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to establish and preserve proprietary rights in the information in the material being
submitted for publication or presentation.
11. Term and Termination
11.1 Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and
end upon the date of expiration of all payment obligations for all Products, unless earlier
terminated as provided in this Agreement.
11.2 Termination for Material Breach.
11.2.1 Any material failure by a Party (the “Breaching Party”) to comply with any of its
material obligations provided for in this Agreement shall entitle the other Party (the
“Non-Breaching Party”) to give to the Breaching Party written notice specifying the nature of the
material breach, requiring the Breaching Party to make good or otherwise cure such material breach.
11.2.2 If such breach is not cured within [***] days after the receipt of notice pursuant to
Section 11.2.1 above, the Non-Breaching Party shall have the right, on written notice to the
Breaching Party, to terminate this Agreement without prejudice to any of its other rights and
remedies conferred on it by this Agreement or by law.
11.3 Termination at Will. At any time following the completion of the [***] for the MT203
Product described on Exhibit C and performed pursuant to the Development Plan, Nycomed may
terminate this Agreement it its entirety, for any reason or no reason by written notice to Micromet
effective upon [***] days from the date of receipt of the notice by Micromet.
12. Effects of Termination
12.1 Program Transfer upon Termination. Upon any termination of this Agreement, Nycomed
shall, at no cost to Micromet, transfer to Micromet or its designee all materials, documentation,
processes, regulatory filings, licenses, and other items as are reasonably necessary for Micromet
to continue the development or Commercialization of each Product (such transfer, including the
actions listed below hereafter referred to as the “Program Transfer”). Without limiting the
generality of the foregoing, Nycomed shall:
(a) upon Micromet’s request, assign to Micromet any agreements between Nycomed and Third
Parties relating solely to the development, Commercialization or manufacture of each Product;
(b) deliver or return to Micromet all data, materials, and other deliverables developed under
the Development Plan and treat the foregoing as “Confidential Information” of Micromet under
Section 9;
(c) assign to Micromet its entire right, title and interest in and to any trademarks, trade
dress, logos, slogans, designs and copyrights relating specifically to the Products, including any
registrations for the foregoing;
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(d) transfer to Micromet all clinical and commercial supplies of the Products in Nycomed’s
possession or control;
(e) transfer to Micromet the management and continued performance of any clinical trials for
each Product ongoing as of the effective date of such termination;
(f) transfer to Micromet any and all regulatory filings and approvals relating to each
Product, including any INDs and BLAs.
(g) complete all manufacturing activities ongoing as of the effective date of such termination
and, upon Micromet’s request, provide Micromet with clinical and commercial quantities of each
Product until such time as Micromet or its designee has established and validated a manufacturing
process for such Product and is approved to manufacture pivotal trial and commercial supplies of
such Product, at no cost to Micromet; provided, that Micromet shall reimburse Nycomed for [***] %
of the reasonable and documented costs incurred by Nycomed in such manufacturing activities
performed by or on behalf of Nycomed following the date [***] months after the effective date of
termination of this Agreement;
(h) upon Micromet’s request, transfer the completed manufacturing process for each Product to
Micromet or its designee; and
(i) grant to Micromet a worldwide, irrevocable, exclusive license (with the right to grant and
authorize the further grant of sublicenses), under any intellectual property right of Nycomed
related to any of the items described in Section 12.1.1(a)-(h) and under any Patents Controlled by
Nycomed claiming the use, manufacture, or sale of each Product, to make, have made, use, offer for
sale, sell and import such Product.
12.1.2 In consideration of the Program Transfer, Micromet shall pay to Nycomed,
notwithstanding the reason of termination, a royalty of [***] % on Net Sales of each Product until
such time as Nycomed has received an amount equivalent to [***] and the [***] pursuant to this
Agreement; provided, however, that the foregoing shall not limit either Party’s rights or remedies
under this Agreement or at law or in equity. No other compensation shall be owed by Micromet to
Nycomed in connection with the Program Transfer or Micromet’s practice of the license granted under
Section 12.1.1(i).
12.2 Rights Upon Expiration. Upon expiration of this Agreement pursuant to Section 11.1,
Nycomed shall have a non-exclusive, fully paid, royalty-free right and license under the Licensed
Technology to make, have made, use, sell, offer for sale, and import all Products in the Territory
in the Field.
12.3 Accrued Rights. Termination of this Agreement for any reason shall be without prejudice
to any rights that shall have accrued to the benefit of a Party prior to the effective date of such
termination. Such termination shall not relieve a Party from obligations that are expressly
indicated to survive the termination of this Agreement.
12.4 Survival. Sections 3.7, 5.4, 6.5, 6.7 (only with respect to pending actions), 7 and 8
(only as to accrued and unpaid amounts), 9, 12, 13, 15 and 16, together with any definitions
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used or exhibits referenced therein, shall survive any termination or expiration of this
Agreement.
13. Indemnification and Insurance
13.1 Indemnification of Micromet. Nycomed shall 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) (collectively, “Losses”) arising in
connection with any and all claims, demands, lawsuits, or investigations by a Third Party (each a
“Third Party Claim”) against a Micromet Indemnitee, to the extent caused by or arising out of: (a)
any breach by Nycomed of this Agreement, (b) the gross negligence or willful misconduct on the part
of Nycomed or its Affiliates, licensees or sublicensees in performing any activity contemplated by
this Agreement; or (c) the development, manufacture or Commercialization of any Product in the
Territory by Nycomed, its Affiliates, agents or sublicensees after the Effective Date, in each
case, excluding any Losses for which Micromet has an obligation to indemnify Nycomed pursuant to
Section 13.2.
13.2 Indemnification of Nycomed. Micromet shall indemnify Nycomed, its Affiliates, and their
respective directors, officers, and employees (each, a “Nycomed Indemnitee”), and defend and save
each of them harmless from and against any and all Losses arising in connection with any Third
Party Claim against a Nycomed Indemnitee, to the extent caused by or arising out of: (a) any breach
by Micromet of this Agreement, (b) the gross negligence or willful misconduct on the part of
Micromet or its Affiliates in performing any activity contemplated by this Agreement; or (c) a
claim arising from: i) the development, ii) manufacture or iii) use of any Product, in each case
taking place prior to the Effective Date, by Micromet, its Affiliates, agents or sublicensees, in
each case, excluding any Losses for which Nycomed has an obligation to indemnify Micromet and its
Affiliates pursuant to Section 13.1.
13.3 Notice of Claim. All indemnification claims in respect of any Nycomed Indemnitee or
Micromet Indemnitee seeking indemnity under Sections 13.1 or 13.2 (collectively, the “Indemnitees”
and each an “Indemnitee”) shall be made solely by the corresponding Party (the “Indemnified
Party”). The Indemnified Party shall 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 13.1 or Section
13.2, but in no event shall the Indemnifying Party be liable for any Losses that result from any
delay in providing such notice. Each Indemnification Claim Notice must contain a description of
the claim and the nature and amount of such Loss (to the extent that the nature and amount of such
Loss are known at such time). Together with the Indemnification Claim Notice, the Indemnified
Party shall furnish promptly to the Indemnifying Party copies of all notices and documents
(including court papers) received by any Indemnitee in connection with the Third Party Claim.
13.4 Control of Defense. At its option, the Indemnifying Party may assume the defense of any
Third Party Claim subject to indemnification as provided for in Sections 13.1 and 13.2 by giving
written notice to the Indemnified Party within [***] days after the Indemnifying Party’s receipt
of an Indemnification Claim Notice. Upon assuming the defense of a Third Party
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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. Should the Indemnifying Party assume
the defense of a Third Party Claim, the Indemnifying Party shall 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.
13.5 Right to Participate in Defense. Without limiting Section 13.4, any Indemnitee shall 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 shall be at the
Indemnitee’s own expense unless (a) the employment thereof has been specifically authorized by the
Indemnifying Party in writing, or (b) the Indemnifying Party has failed to assume the defense and
employ counsel in accordance with Section 13.4 (in which case the Indemnified Party shall control
the defense).
13.6 Settlement. With respect to any Losses relating solely to the payment of money damages
in connection with a Third Party Claim and that shall not result in the Indemnitee’s becoming
subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee
in any manner, and as to which the Indemnifying Party shall have acknowledged in writing the
obligation to indemnify the Indemnitee hereunder, the Indemnifying Party shall 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, shall deem appropriate, and
shall transfer to the Indemnified Party all amounts which said Indemnified Party shall be liable to
pay prior to the time of the entry of judgment. With respect to all other Losses in connection
with Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party
Claim in accordance with Section 13.4, the Indemnifying Party shall have authority to consent to
the entry of any judgment, enter into any settlement or otherwise dispose of such Loss provided it
obtains the prior written consent of the Indemnified Party (which consent shall be at the
Indemnified Party’s sole and absolute discretion). The Indemnifying Party that has assumed the
defense of the Third Party Claim in accordance with Section 13.4 shall not be liable for any
settlement or other disposition of a Loss by an Indemnitee that is reached without the written
consent of such Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend
or prosecute any Third Party Claim, no Indemnitee shall admit any liability with respect to, or
settle, compromise or discharge, any Third Party Claim without first offering to the Indemnifying
Party the opportunity to assume the defense of the Third Party Claim in accordance with Section
13.4.
13.7 Cooperation. If the Indemnifying Party chooses to defend or prosecute any Third Party
Claim, the Indemnified Party shall, and shall cause each other Indemnitee to, cooperate in the
defense or prosecution thereof and shall 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 shall
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 shall reimburse the
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Indemnified Party for all its reasonable out-of-pocket expenses in connection with such
cooperation.
13.8 Expenses. Except as provided above, the reasonable and verifiable costs and expenses,
including fees and disbursements of counsel, incurred by the Indemnified Party in connection with
any claim shall be reimbursed on a calendar quarter basis by the Indemnifying Party, without
prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.
13.9 Insurance. During the Term, each Party shall have and maintain such types and amounts of
liability insurance as is normal and customary in the industry generally for parties similarly
situated, and shall upon request provide the other Party with a copy of its policies of insurance
in that regard, along with any amendments and revisions thereto.
14. Representations and Warranties
14.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other Party that, as of the Effective Date:
14.1.1 Such Party (a) has the corporate power and authority to enter into this Agreement and
perform its obligations hereunder, and (b) has taken all necessary corporate action on its part
required to authorize the execution and delivery of this Agreement and the performance of its
obligations hereunder;
14.1.2 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;
14.1.3 The execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any requirement of any provision of the
articles of incorporation, bylaws or any similar instrument of such Party in any material way, and
(b) do not conflict with, violate, or breach or constitute a default or require any consent under,
any contractual obligation or court or administrative order by which such Party is bound.
14.1.4 Such Party is a corporation duly organized, validly existing and in good standing under
the laws of the country of its incorporation, 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.
14.2 Additional Representations and Warranties of Micromet. Micromet hereby represents and
warrants to Nycomed that, as of the Effective Date:
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
31
14.2.1 To the knowledge of Micromet, and except as expressly notified to Nycomed with
reference to this Section 14.2.1 prior to the Effective Date, the research, development,
Commercialization or use of the MT203 Product does not infringe an issued Patent of any Third Party
in the Territory.
14.2.2 Micromet has the right to grant the rights and licenses described in this Agreement.
14.2.3 To the knowledge of Micromet, there is no Third Party infringing any of the Licensed
Patents or using any of the Licensed Know-How contrary to the rights granted to Nycomed pursuant to
this Agreement.
14.2.4 Micromet has not been served with any interference action or litigation asserting the
invalidity, misuse, unregisterability, unenforceability or non-infringement of any of the Licensed
Patents or challenging Micromet’s rights to use any of the Licensed Patents or making any adverse
claim of ownership thereof and claiming any part of the MT203 Product or related to the MT203
Product or the manufacture hereof, and Micromet has not received any written communication which
expressly threatens interference actions or other litigation described above before any patent and
trademark office, court, or any other governmental entity in any jurisdiction in regard to any such
Licensed Patents.
14.2.5 Micromet has provided Nycomed’s internal patent counsel, during a due diligence meeting
conducted on March 13, 2007 and subsequent telephone conferences, with access to complete copies of
the most current versions of all pending patent applications included in the Licensed Patents and
all material correspondence between Micromet and any patent office with respect to the pending
patent applications included in the Licensed Patents as of the Effective Date.
14.2.6 Prior to the Effective Date, all maintenance fees associated with the Licensed Patents
that have issued as of the Effective Date have been paid;
14.2.7 Prior to the Effective Date, Micromet has used commercially reasonable efforts to
maintain the Licensed Technology under its control in confidence and has not disclosed,
distributed, or disseminated such information to anyone who is not in turn under an obligation to
Micromet to maintain this information in confidence.
14.2.8 To the knowledge of Micromet, there are no inquiries, actions, investigations or other
proceedings pending before or threatened by any Regulatory Authority with respect to the MT203
Product or any facility where the MT203 Product is manufactured, and Micromet, to its knowledge,
has not received written notice threatening any such inquiry, action, investigations or other
proceeding.
14.2.9 To the knowledge of Micromet, no party to any of the Upstream Agreements is in breach
of such Agreement.
14.2.10 To the knowledge of Micromet, the development and manufacture of the Product has been
conducted by Micromet, its Affiliates and subcontractors, to the extent necessary, in compliance in
all material respects with Applicable Law.
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
32
14.2.11 As used herein, “knowledge of Micromet” means the actual knowledge, as of the
Effective Date, of any executive officer of Micromet with operational responsibility for the
subject matter of the applicable representation or warranty.
14.3 Additional Covenants of Micromet.
14.3.1 Micromet shall not amend or waive, or take any other action or commit any omission that
would alter, any of its rights under any of the Upstream Agreements in any manner that would
materially and adversely affect Nycomed’s rights and benefits under this Agreement; and
14.3.2 Micromet shall not license, sell or otherwise transfer any right, title or interest in,
to or under any Licensed Technology in contravention of the rights and licenses granted to Nycomed;
provided, however, that the foregoing shall not limit Micromet’s rights under Section 16.2.
15. Disclaimer; Limitation of Liability
15.1 Disclaimer of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 14,
NYCOMED 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 NYCOMED AND MICROMET EACH SPECIFICALLY
DISCLAIMS ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR
IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR
PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
15.2 Limitation of Liability. IN NO EVENT SHALL 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 SHALL NOT APPLY TO AN AWARD OF ENHANCED DAMAGES AVAILABLE
UNDER THE PATENT LAWS FOR WILLFUL PATENT INFRINGEMENT AND SHALL NOT LIMIT EITHER PARTY’S
OBLIGATIONS TO THE OTHER PARTY UNDER SECTIONS 9, 10 AND 13.
16. Miscellaneous
16.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or
be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or
performing any term of this Agreement when such failure or delay is caused by or results from
events beyond the reasonable control of the non-performing Party, including fires, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
33
God or acts, omissions or delays in acting by any governmental authority. The non-performing
Party shall notify the other Party of such force majeure within [***] 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 shall be of no greater scope and no longer duration than is necessary and the
non-performing Party shall use commercially reasonable efforts to remedy its inability to perform;
provided, however, that in the event the suspension of performance continues for [***] days 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.
16.2 Assignment. Neither Party shall sell, transfer, assign, delegate, pledge or otherwise
dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or
any of its rights or obligations under this Agreement without the prior written consent of the
other Party (which consent may be granted, withheld or conditioned at such other Party’s sole and
absolute discretion); provided, however, that either Party may assign or transfer this Agreement or
any of its rights or obligations under this Agreement without the consent of the other Party (a) to
any Affiliate of such Party provided that such transfer and assignment shall be effective for only
so long as such Affiliate remains an 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. The
assigning Party (unless it is not the surviving entity) shall 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 shall assume in writing all of the
assigning Party’s obligations under this Agreement. Any purported assignment or transfer in
violation of this section shall be void ab initio and of no force or effect.
16.3 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 shall not be materially and adversely affected thereby, (a) such provision
shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal,
invalid or unenforceable provision had never comprised a part of this Agreement, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall 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 shall 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.
16.4 Governing Law; Dispute Resolution.
16.4.1 This Agreement, and any claim, dispute, or controversy of whatever nature arising out
of or relating to this Agreement shall be governed by and construed in accordance with the laws of
Germany, without giving effect to any principles, statutory provisions or other rules of choice of
law that would require the application of the laws of a different state or country.
16.4.2 The Parties shall try to settle their differences amicably between themselves. If any
claim, dispute, or controversy of whatever nature arising out of or relating to
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
34
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 shall,
before initiating any proceedings pursuant to Section 16.4.3, notify the other Party in writing of
such Dispute. If the Parties are unable to resolve the Dispute within [***] days of receipt of
the written notice by the other Party, such dispute shall be referred to a member of each of the
Party’s senior executive management, with appropriate decision making authority (or its designee),
who is not on the JSC, who shall meet in person at least once and use their good faith efforts to
resolve the Dispute within [***] days after such referral.
16.4.3 If a Dispute is not resolved as provided in the preceding Section 16.4.2, whether
before or after termination of this Agreement, the Parties hereby agree to the exclusive
jurisdiction of the courts of competent jurisdiction in Frankfurt, Germany. Each Party hereby
agrees to such exclusive jurisdiction and waives any objections as to the personal jurisdiction or
venue of such courts.
16.4.4 Notwithstanding the provisions of this Section 16.4, either Party shall have the right
to seek temporary injunctive relief in any court of competent jurisdiction as may be available to
such Party under the laws and rules applicable in such jurisdiction.
16.5 Notices. All notices or other communications that are required or permitted hereunder
shall 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 Nycomed, to:
Altana Pharma XX
Xxx Xxxxxx Xxx. 0
00000 Xxxxxxxx
Xxxxxxx
Attention: General Counsel
Facsimile: xx00 0000 00 0000
Xxx Xxxxxx Xxx. 0
00000 Xxxxxxxx
Xxxxxxx
Attention: General Counsel
Facsimile: xx00 0000 00 0000
If to Micromet, to:
Micromet AG
Xxxxxxxxxxxxx. 0
00000 Xxxxxx
Xxxxxxx
Attention: Business Development
Facsimile: xx00 00 000 000 000
Xxxxxxxxxxxxx. 0
00000 Xxxxxx
Xxxxxxx
Attention: Business Development
Facsimile: xx00 00 000 000 000
with a copy to:
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
35
Bethesda, MD
Attention: General Counsel
Facsimile: x0-000-000-0000
Attention: General Counsel
Facsimile: x0-000-000-0000
or to such other address as the Party to whom notice is to be given may have furnished to the other
Party in writing in accordance with this Agreement. Any such communication shall 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 16.5 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.
16.6 Entire Agreement; Modifications. This Agreement 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 February 7, 2007. Each Party confirms that it is not relying
on any representations or warranties of the other Party except those that are expressly made in
this Agreement. No amendment or modification of this Agreement shall be binding upon the Parties
unless made in writing and duly executed by authorized representatives of both Parties, including
any amendment to, or waiver of, the foregoing requirement that all amendments shall be made in
writing.
16.7 Relationship of the Parties. It is expressly agreed that the relationship between the
Parties is and shall be that of independent contractors, and that the relationship between the
Parties shall not constitute a partnership, joint venture or agency. Neither Party shall have the
authority to make any statements, representations or commitments of any kind, or to take any
action, which shall be binding on the other, without the prior written consent of the other to do
so. All persons employed by a Party shall be employees of such Party and not of the other Party
and all costs and obligations incurred by reason of any such employment shall be for the account
and expense of such Party.
16.8 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 shall 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 shall 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.
16.9 Counterparts. This Agreement may be executed in 2 or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument.
16.10 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 shall not be construed as conferring any rights on any
other parties.
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
36
16.11 Further Assurance. Each Party shall 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.
16.12 English Language. This Agreement has been written and executed in the English language.
Any translation into any other language shall 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 shall control.
16.13 Construction. Except where the context otherwise requires, wherever used, the singular
shall include the plural, the plural the singular, the use of any gender shall be applicable to all
genders, and the word “or” is used in the inclusive sense (and/or). The captions of this Agreement
are for convenience of reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this Agreement. The term
“including” as used herein means including, without limiting the generality of any description
preceding such term. References to “Section” or “Exhibit” are references to the numbered sections
of this Agreement and the exhibits attached to this Agreement, unless expressly stated otherwise.
[Remainder of this page is left blank intentionally]
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
37
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 | Altana Pharma AG | |||||||||
By:
|
By: | |||||||||
Name: Xxxxxxx Xxxxxxxx | Name: Xxxxxx Xxxxxx | |||||||||
Title: CSO | Title: Board of Management | |||||||||
By:
|
By: | |||||||||
Name: Xxxx Xxxxxxxx | Name: Xxxxxxxxx Xxxxxxxxxxx | |||||||||
Title: VP Business Development |
Title: Corporate Vice President |
[Signature Page To The Collaboration And License Agreement]
*** | Certain information in this document has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Exhibit A-1
Licensed Patents
Application | Application | |||||||
Number | Filing Date | Country | Title of Application | Status | ||||
[***]
|
[***] | [***] | [***] | [***] |
* | Subject to the terms of an Upstream Agreement |
*** | 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
Licensed Patents
Application | Application | |||||||
Number | Filing Date | Country | Title of Application | Status | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] | ||||
[***]
|
[***] | [***] | [***] | [***] |
* | Subject to the terms of an Upstream Agreement |
*** | 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
MT203 Amino Acid Sequence of Variable Domains
[***]
*** | 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
Development Plan Outline
*** | 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
List of Upstream Agreements
[***]
Upon exercise of the SCA Patent option pursuant to Section 6.2.2:
[***]
*** | 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
Milestone Schedule
Milestone Event | Milestone Payment | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***] |
||
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***] |
||
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***] |
||
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] | |
[***]
|
[***] |
*** | 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. |
Milestone Event | Milestone Payment | |
[***]
|
[***] | |
[***]
|
[***] |
If a milestone event described above is achieved that is subsequent to a preceding milestone
event with respect to which Nycomed has not yet made the corresponding milestone payment, the
preceding milestone event is deemed achieved, and the corresponding milestone payment is due and
payable together with the payment of the milestone payment for the subsequent milestone event.
*** | 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 F
SCA PATENTS
Application | Application | |||||||||
Number | Filing Date | Country | Title of Application | Status | Patent Number | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] |
*** | 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 | |||||||||
Number | Filing Date | Country | Title of Application | Status | Patent Number | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] | |||||
[***] |
[***] | [***] | [***] | [***] | [***] |
[***]
[***] | [***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
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[***] | [***] | [***] | [***] | [***] | |||||
[***]
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[***] | [***] | [***] | [***] | ||||||
[***]
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[***] | [***] | [***] | [***] | ||||||
[***]
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[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] |
*** | 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. |
[***] | [***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] |
* | The license rights granted under this Agreement do not apply to claims relating to those antibodies of specific sequences binding to [***] , which antibodies are described or disclosed in the above-described Patents, and such claims are excluded from the definition of the SCA Patents. |
Application | ||||||||||
Application | Filing | |||||||||
Number | Date | Country | Title of Application | Status | Patent Number | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | |||||
[***]
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[***] | [***] | [***] | [***] | [***] | |||||
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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 G
[***]
*** | 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 H
Press Release
*** | 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 I
Excluded Field
Any license granted pursuant to this Agreement shall not include the right to use, research,
develop, manufacture, use, or commercialize the following products:
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |