GM-CSF License Agreement
Exhibit 10.40
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
GM-CSF License Agreement
This GM-CSF License Agreement (the “Agreement”) is made and entered into
effective as of November 21, 2005 (the “Effective Date”), by and between Micromet AG,
having its principal offices at Xxxxxxxxxxxxxxxxx 0, 00000 Xxxxxx, Xxxxxxx (“Micromet”), and
Enzon Pharmaceuticals, Inc., having its principal offices at 000 Xxxxx 000/000,
Xxxxxxxxxxx, Xxx Xxxxxx 00000, XXX (“Enzon”). Micromet and Enzon each may be referred to herein
individually as a “Party,” or collectively as the “Parties.”
Whereas, on the Effective Date the Parties have terminated that certain Collaboration
Agreement, dated as of April 9, 2002, as amended on June 28, 2004 (the “Collaboration Agreement”);
Whereas, the Parties performed certain research activities under the GM-CSF Program,
as defined below, pursuant to the Collaboration Agreement;
Whereas, the Parties desire to reallocate the rights and responsibilities of the
Parties with respect to further research and development of the GM-CSF Target (as defined below);
Now, therefore, 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, intending to be legally bound, do hereby
agree as follows:
1. Definitions
When used in this Agreement, capitalized terms will have the meanings as defined below and
throughout the Agreement. Unless the context indicates otherwise, the singular will include the
plural and the plural will include the singular. Any references herein to the Collaboration
Agreement, including definitions defined by reference, will be construed as referring to the
Collaboration Agreement as it existed immediately prior to its termination on the Effective Date.
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 that, if local law restricts foreign ownership, control will be established
by direct or indirect ownership of the maximum ownership percentage that may, under such local law,
be owned by foreign interests.
1.2 “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.
1.3 “Antibody Product” means any composition or formulation consisting of or comprising one or
more Antibodies (other than Single Chain Antibodies) that is under development, approved or used
for the diagnosis, prophylaxis or treatment of human or non-human diseases or conditions.
1.4 “Antigen” means any structure with binding affinity to antibody variable domains.
1.5 “BiTE Product” means any composition or formulation consisting of or comprising a
bi-specific Single Chain Antibody expressed as a single polypeptide chain, binding to T-cells.
1.6 “BLA” means a Biologics License Application, as defined in the U.S. Federal Food, Drug,
and Cosmetics Act, as amended, and the regulations promulgated thereunder, or a foreign equivalent
to such application.
1.7 “Collaboration Agreement” has the meaning set forth in the recitals of this Agreement.
1.8 “Commercialization” means the marketing, promotion, advertising, selling or distribution
of a pharmaceutical product in a country after marketing approval has been obtained in such country
for such product. The term “Commercialize” has a correlative meaning.
1.9 “Commercialization Partner” means a Third Party that is a party to a Product License
Agreement.
1.10 “Controlled” means, with respect to any Know-How, Patent, or other intellectual property
right, possession of the right, whether directly or indirectly, and whether by ownership, license
or otherwise, to assign, or grant a license, sublicense or other right to or under, such Know-How,
Patent or right as provided for herein without violating the terms of any agreement or other
arrangements with any Third Party.
1.11 “Xxxxx Xxxxx-License Agreements” means those certain cross-license agreements dated as of
November 23, 1993, between Enzon and Creative BioMolecules, Inc., with respect to which Curis, Inc.
was the assignee of Creative BioMolecules, Inc., and with respect to which Micromet was the
assignee of Curis, Inc.
1.12 “Enzon GM-CSF Know-How” means any and all Know-How in the Control or possession of Enzon
or its Affiliates that was generated under the GM-CSF Program and that relates to the research and
development of pharmaceutical products binding to the GM-CSF Target.
1.13 “Enzon Collaboration Patents” has the meaning as defined in the Collaboration Agreement
(which definition is hereby incorporated herein by reference).
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1.14 “Enzon Licensed Patents” means those Patents now owned by or licensed to Enzon which were
the subject of a nonexclusive license to Micromet, as ultimate assignee of Creative BioMolecules,
Inc., pursuant to the Xxxxx Xxxxx-License Agreements, including without limitation those Patents
identified in Appendix A hereto.
1.15 “Enzon Licensed Technology” means the Enzon Licensed Patents, Enzon Collaboration Patents
and the Enzon GM-CSF Know-How.
1.16 “Exploit” or “Exploitation” means to make, have made, import, use, sell, offer for sale,
or otherwise dispose of a product, including all discovery, research, development, registration,
modification, enhancement, improvement, manufacture, storage, formulation, exportation,
transportation, distribution, promotion and marketing activities related thereto.
1.17 “GM-CSF Program” means the program of research relating to the GM-CSF Target undertaken
pursuant to the Collaboration Agreement.
1.18 “GM-CSF Target” means the whole or part of the human granulocyte macrophage-colony
stimulating factor identified by the SWISS-PROT entry name CSF2_HUMAN and accession number P04141.
1.19 “Industrial SCA Product” means any composition or formulation consisting of or comprising
one or more Single Chain Antibodies intended for any use other than for research or diagnosis,
prophylaxis, or treatment of disease or conditions in humans and other animals.
1.20 “Know-How” means (a) any scientific or technical information, results and data of any
type whatsoever, in any tangible or intangible form whatsoever, including databases, practices,
methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical test data, analytical and quality control data, stability
data, studies and procedures, and manufacturing process and development information, results and
data, and (b) any biological, chemical, or physical materials.
1.21 “Licensed Antibody” means any Antibody (including Single Chain Antibodies) that binds to
the GM-CSF Target and: (i) is identified by or on behalf of Micromet through the use of any Enzon
Licensed Technology, or (ii) the composition, manufacture, use or sale of which is embraced by any
Enzon Licensed Technology.
1.22 “Licensed Product” means any Antibody Product, SCA Product, Non-Human SCA Product,
Research Product, Industrial SCA Product, or BiTE Product that consists of, comprises or contains a
Licensed Antibody.
1.23 “Losses” means all losses, damages, liabilities, costs and expenses (including reasonable
attorneys’ fees and expenses) in connection with any and all liability suits, investigations,
claims or demands.
1.24 “Net Sales” has the meaning assigned to it in Appendix C.
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1.25 “Non-Human SCA Product” means any composition or formulation consisting of or comprising
one or more Single Chain Antibodies under development, approved or used for the diagnosis,
prophylaxis or treatment of non-human diseases or conditions, but excluding any BiTE Products.
1.26 “Other Patents” means any Patents Controlled by Enzon as of the Effective Date as well as
any Patents claiming inventions first conceived or reduced to practice by or on behalf of Enzon or
its respective Affiliates as of the Effective Date or first filed within [***] thereafter, but
excluding any Patent that is (i) a Collaboration Patent, or (ii) an Enzon Licensed Patent. For the
avoidance of doubt, “Other Patents” excludes any Patents Controlled at the time of a Change of
Control by a Third Party that is a party in the transaction resulting in a Change of Control of
Enzon. “Change of Control” means the sale of more than [***]% of Enzon’s voting stock or more than
[***]% of Enzon’s assets (on the basis of their book value) to a Third Party or group of Third
Parties acting in concert, or a swap, contribution or merger including within the meaning of the
Law on the Transformation of Companies (Umwandlungsgesetz) in respect of which more than [***]% of
Enzon’s voting stock.
1.27 “Patents” means (a) all patents and patent applications in any country or supranational
jurisdiction, and (b) any substitutions, divisions, continuations, continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations, extensions, supplementary protection
certificates and the like, and any provisional applications, of any such patents or patent
applications.
1.28 “Product License Agreement” means any agreement between Micromet and a Third Party under
which such Third Party is granted the right to Commercialize a Licensed Product.
1.29 “Research Product” means a product consisting of, comprising or containing one or more
Single Chain Antibodies used for research purposes and not for the diagnosis, prophylaxis or
treatment of human or non-human diseases or conditions.
1.30 “Royalty Term” has the meaning ascribed to it in Section 3.1.
1.31 “SCA Product” means any composition or formulation consisting of or comprising one or
more Single Chain Antibodies that is under development, approved or used for the diagnosis,
prophylaxis or treatment of human diseases or conditions, but excluding any BiTE Product.
1.32 “Single Chain Antibody” means a single chain polypeptide having binding affinity for an
Antigen and a defined amino acid sequence whereby such polypeptide comprises (i) a first
polypeptide segment having a light chain variable region, (ii) a second polypeptide having a heavy
chain variable region, and (iii) at least one peptide linker linking the first and second
polypeptides into a single chain polypeptide.
1.33 “Term” has the meaning assigned to it in section 7.1.
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1.34 “Therapeutic SCA Product” means an SCA Product under development or approved for the
treatment or prophylaxis of human diseases or conditions.
1.35 “Third Party” means any party other than Micromet, Enzon or their respective Affiliates.
1.36 “Valid Claim” means (a) any claim of an issued and unexpired patent within the Enzon
Licensed Patents which has not been held unenforceable or invalid by a court or other governmental
agency of competent jurisdiction in an unappealed or unappealable decision, and which has not been
disclaimed or admitted to be invalid or unenforceable through reissue or otherwise, or (b) a
pending claim in a pending patent application within the Enzon Licensed Patents. Notwithstanding
clause (b) above, in the event that a pending claim in a pending patent application does not issue
as a valid and enforceable claim in an issued patent within [***] years after the earliest date
from which such patent application claims priority, such a pending claim will not be a Valid Claim,
unless and until such pending claim subsequently issues as a valid and enforceable claim in an
issued patent, in which case such claim will be reinstated and be deemed to be a Valid Claim as of
the date of issuance of such patent.
2. Grant Of License
2.1 License Grant.
2.1.1 Enzon hereby grants to Micromet an exclusive, worldwide, royalty-bearing (as set forth
in section 3.1) license under the Enzon Licensed Technology to Exploit Licensed Products.
2.1.2 Enzon hereby grants to Micromet a worldwide, non-exclusive, fully paid-up, royalty-free,
perpetual, irrevocable and non-terminable license under the PEG Collaboration Patents (as defined
in the Collaboration Agreement, which definition is hereby incorporated in this Agreement by
reference), with the right to grant and authorize the grant of sublicenses, to Exploit Licensed
Products.
2.1.3 The licenses set forth in this section 2.1 shall be subject to the field limitations set
forth on Appendix B.
2.1.4 Freedom to Operate. Enzon hereby grants Micromet a worldwide, royalty-free,
non-exclusive license under its Other Patents, with the right to grant and authorize the grant of
sublicenses, to Exploit Licensed Products.
2.2 Amending Field Limitations. The field limitations listed in Appendix B set forth the
understanding of the Parties as of the Effective Date regarding the scope of such limitations
arising from license agreements under which licenses to Patents within the Enzon Licensed Patents
were granted to Third Parties prior to the Effective Date. Upon request of a Party, the Parties
will amend Appendix B as necessary to include additional or different limitations of which the
requesting Party in good faith was unaware as of the Effective Date.
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Furthermore, upon expiration or termination of a license agreement that was the basis of a
limitation listed in Appendix B, such limitation will be deemed stricken from Appendix B as of the
date of such expiration or termination.
2.3 Technology Transfer. Enzon will provide or make available to Micromet any Enzon GM-CSF
Know-How or other materials or data relating to the GM-CSF Program that exist as of the Effective
Date and that are necessary or useful for the development of Licensed Products, as reasonably
requested by Micromet. Enzon will transfer such materials in accordance with procedures agreed
upon by the Parties.
2.4 Exclusivity. Enzon hereby covenants during the [***]year period commencing on the
Effective Date not to commence or perform, itself or with or through an Affiliate or any Third
Party, any research program or other activities directed at identifying, developing or
commercializing any Antibody (including Single Chain Antibodies) that binds to the GM-CSF Target.
3. Financial Terms
3.1 Royalty on Net Sales. Micromet will pay to Enzon a royalty equal to [***]% of Net Sales
of Licensed Products. The term of such royalty payment obligation (the “Royalty Term”) will
commence as of the first commercial sale of a Licensed Product by Micromet, its Affiliates or
sublicensees in a particular country and will expire, on a country-by-country basis, [***] years
after such first commercial sale. Such royalty will be due within [***] ([***]) days following the
end of each calendar quarter during which Net Sales occurred or, if later, within [***] ([***])
days after receipt of the royalty payment with respect to such Net Sales from a sublicensee.
3.2 Payment Terms.
3.2.1 Reporting. On or before January 30 of each year during the Term until the first receipt
of Net Sales, Micromet will provide to Enzon a written annual report on the development activities
undertaken by Micromet with respect to Licensed Products. Micromet will inform Enzon in writing
upon the first receipt of any amount of Net Sales. After the first receipt of Net Sales, Micromet
will provide together with the payment of the royalty (but in no
event later than [***] after each
calendar quarter during which Net Sales accrued) a written report showing the gross revenues and
the calculation of Net Sales. In addition, each such report will include information on revenues
and expenses in such detail as may be reasonably required to determine the accuracy of such
calculation, including information on costs deducted from revenues in the calculation of Net Sales.
3.2.2 Payment Method. All amounts due hereunder will be paid in U.S. Dollars by wire transfer
in immediately available funds to an account designated by Enzon. Any payments or portions thereof
due hereunder which are not paid on the date such payments are due under this Agreement will bear
interest at the lower of (i) [***]% over the overnight LIBOR
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rate in effect on the due date, and (ii) the maximum rate permitted by law, calculated on the
number of days such payment is delinquent, compounded monthly.
3.2.3 Currency Conversion. For any currency conversion required in connection with any
payment hereunder, such conversion will be made at the prevailing commercial rate of exchange for
purchasing the currency into which an amount is to be converted as publicly announced by Citibank
N.A. (or its successor) in New York on the last business day of the calendar quarter to which such
payments relate. The calculation of Net Sales will be made in accordance with Micromet’s standard
accounting procedures applied by Micromet in its operations.
3.2.4 Records Retention. Micromet will maintain complete and accurate books, records and
accounts in sufficient detail to confirm the accuracy of any payments required hereunder, which
books, records and accounts will be retained by Micromet until [***] years after the end of the
period to which such books, records and accounts pertain.
3.2.5 Audit. Enzon will have the right to have an independent certified public accounting
firm of internationally recognized standing, reasonably acceptable to Micromet, to have access
during normal business hours, and upon reasonable prior written notice, to such of the records of
Micromet as may be reasonably necessary to verify the accuracy of amounts reported and payments
required hereunder (“Payment Information”) for any calendar quarter ending not more than 36 months
prior to the date of such request; provided, however, that Enzon will not have the
right to conduct more than [***]. The accounting firm will disclose to both Parties whether such
Payment Information is correct or incorrect and the specific details concerning any discrepancies.
Enzon will bear all costs of such audit, unless the audit reveals an underpayment of more than
[***]% of the amount paid, in which case Micromet will bear the cost of the audit.
3.2.6 Payment of Additional Amounts. If, based on the results of any audit, additional
payments are owed by Micromet under this Agreement, then Micromet will make such additional
payments promptly after the accounting firm’s written report is delivered to both Parties. If,
based on the results of any audit, payments made pursuant to section 3.1 exceeded payments
indicated by the audit as being due thereunder, such excess will be credited against future amounts
owed by Micromet under section 3.1.
3.2.7 Confidentiality. Enzon will treat all information subject to review under this section
3.2 in accordance with the confidentiality provisions of section 6 and will cause its accounting
firm to enter into a reasonably acceptable confidentiality agreement with Micromet obligating such
firm to maintain all such financial information in confidence pursuant to such confidentiality
agreement.
4. Filing, Prosecution and Maintenance of Patent Rights
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4.1 Responsibility. Enzon will be solely responsible and bear all costs for the preparation,
filing, prosecution and maintenance of the Enzon Licensed Patents in its sole and absolute
discretion.
4.2 Enforcement. Enzon will be solely responsible and bear all costs for (and enjoy all
recovery from) any inter partes actions concerning the Enzon Licensed Patents, including but not
limited to reexaminations, oppositions, interferences, and infringement actions, all in its sole
and absolute discretion.
4.3 Notice. Enzon will (i) promptly notify Micromet of any actions that may arise pursuant to
section 4.2 and (ii) upon reasonable request by Micromet, provide Micromet a report on the status
of its activities described in section 4.1.
5. Representation and Warranties
5.1 Enzon. Enzon hereby represents and warrants to Micromet that: (i) it has the right to
grant the licenses granted by it pursuant to this Agreement; and (ii) the licenses so granted do
not conflict with or violate the terms of any agreement, assignment, or encumbrance between Enzon
and any person or company.
5.2 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 5.1,
ENZON 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 ENZON AND MICROMET EACH SPECIFICALLY
DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS 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.
6. Confidentiality
6.1 Definition. “Confidential Information” means any 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
disclosed by one Party to the other pursuant to this Agreement.
6.2 Exclusions.
6.2.1 Notwithstanding the foregoing, information of a Party will not be deemed Confidential
Information with respect to a receiving Party for purposes of this Agreement if such information:
(a) was already known to the receiving Party or its Affiliates, other than under an obligation
of confidentiality or non-use, at the time of disclosure to the receiving Party;
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(b) was generally available or known to parties reasonably skilled in the field to which such
information or know-how 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 or know-how pertains, or otherwise became part of the public domain, after its
disclosure to the receiving Party through no fault of or breach of its obligations under this
section 6 by the receiving Party;
(d) was disclosed to the receiving Party other than under an obligation of confidentiality or
non-use, by a Third Party who had no obligation to the Party that Controls such information and
know-how not to disclose such information or know-how to others; or
(e) was independently discovered or developed by the receiving Party or its Affiliates, as
evidenced by their written records, without the use of, and by personnel who had no access to,
Confidential Information belonging to the Party that Controls such information and know-how.
6.2.2 Specific aspects or details of Confidential Information will not be deemed to be within
the public domain or in the possession of a Party merely because the Confidential Information is
embraced by more general information in the public domain or in the possession of such Party.
Further, any combination of Confidential Information will not be considered in the public domain or
in the possession of a Party merely because individual elements of such Confidential Information
are in the public domain or in the possession of such Party unless the combination and its
principles are in the public domain or in the possession of such Party.
6.3 Disclosure and Use Restriction. Except as expressly provided herein, the Parties agree
that, for the Term and for [***] thereafter, each Party and its Affiliates and sublicensees will
keep completely confidential and will not publish or otherwise disclose and will not use for any
purpose except for the purposes contemplated by this Agreement any Confidential Information of the
other Party, its Affiliates or sublicensees.
6.4 Authorized Disclosure. Each Party may disclose Confidential Information of the other
Party to the extent that such disclosure is:
6.4.1 made in response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided, however, that
such Party will first have given notice to such other Party and given such other Party a reasonable
opportunity to quash such order and to obtain a protective order requiring that the Confidential
Information and documents that are the subject of such order be held in confidence by such court or
governmental or regulatory body or, if disclosed, be used only for the purposes for which the order
was issued; and provided, further, that if a disclosure order is not quashed or a
protective order is not obtained, the Confidential Information disclosed in response to such court
or governmental order will be limited to that information which is legally required to be disclosed
in response to such court or governmental order;
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6.4.2 otherwise required by law; provided, however, that the disclosing Party
will provide such other Party with notice of such disclosure in advance thereof to the extent
practicable;
6.4.3 made by such Party to the regulatory authorities as required in connection with any
filing of BLAs, marketing approval applications, or similar applications or requests for regulatory
approvals; provided, however, that reasonable measures will be taken to assure
confidential treatment of such information;
6.4.4 made by such Party, in connection with the performance of this Agreement, to Affiliates,
permitted sublicensees, research parties, employees, consultants, representatives or agents, each
of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least
equivalent in scope to those set forth in this section 6; or
6.4.5 made by such Party to existing or potential acquirers or merger candidates; existing or
potential pharmaceutical collaborators (to the extent contemplated hereunder); investment bankers;
existing or potential investors, venture capital firms or other financial institutions or investors
for purposes of obtaining financing; or Affiliates, each of whom prior to disclosure must be bound
by obligations of confidentiality and non-use at least equivalent in scope to those set forth in
this section 6. Notwithstanding this section 6.4.5, neither Party will disclose any item of the
other Party’s Confidential Information to any existing or potential acquirer or merger partner that
is substantially involved in the Exploitation of Single Chain Antibodies without first providing
such other Party with reasonable advance written notice of each such disclosure.
6.5 Use of Name. Neither Party will make public use of the other Party’s name except (a) in
connection with announcements and other permitted disclosures relating to this Agreement and the
activities contemplated hereby, (b) as required by applicable law, and (c) otherwise as agreed in
writing by such other Party.
6.6 Press Releases.
6.6.1 The Parties will make a joint press release regarding the execution of this Agreement,
the final form of which will be subject to approval of both Parties prior to its release to the
public. For subsequent press releases and other written public disclosures relating to this
Agreement or the Parties’ relationship hereunder (“Proposed Disclosures”), each Party will use
reasonable efforts to submit to the other Party a draft of such Proposed Disclosures for review and
comment by the other Party at least [***] prior to the date on which such Party plans to release
such Proposed Disclosure, and in any event will submit such drafts at least [***] prior to the
release of such Proposed Disclosure, and will review and consider in good faith any comments
provided in response.
6.6.2 If a Party is unable to comply with the foregoing [***] notice requirement because of a
legal obligation or stock exchange requirement to make more rapid disclosure, such Party will not
be in breach of this Agreement but will in that case give telephone notice to a
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senior executive of the other Party and provide a draft disclosure with as much notice as
possible prior to the release of such Proposed Disclosure.
6.6.3 A Party may publicly disclose without regard to the preceding requirements of this
section 6.6 information that was previously disclosed in a Proposed Disclosure that was in
compliance with such requirements.
6.6.4 The requirements of this section 6.6 will not apply to public disclosures, written or
otherwise regarding a Party’s Pipeline Products that do not specifically refer to this Agreement or
the Parties’ relationship hereunder.
6.7 Terms of Agreement to be Maintained in Confidence. Subject to the provisions of this
section 6, including the exception for any public disclosures made in compliance with the terms of
section 6.6, the Parties agree that the terms of this Agreement are confidential and will not be
disclosed by either Party to any Third Party (except to a Party’s professional advisor) without
advance written permission of the other Party, provided that either Party may make any filings of
this Agreement required by law or regulation in any country so long as such Party uses its
reasonable efforts to obtain confidential treatment for portions of this Agreement as available,
consults with the other Party, and permits the other Party to participate, to the extent
practicable, in seeking a protective order or other confidential treatment, and further provided
that either Party may disclose the terms of this Agreement to a Third Party (and its professional
advisors) when such disclosure is reasonably necessary in connection with (i) the grant of a
license or sublicense of the licensed Patents to such Third Party, (ii) a merger, acquisition,
placement, investment, or other such transaction with such Third Party, or (iii) the sale of
securities to or other financing from such Third Party or a financing underwritten by such Third
Party, in which case disclosure may be made to any person or entity to whom such Third Party sells
such securities (and its professional advisers). Advance written permission for disclosure will
not be required when a Party is ordered to disclose information concerning the Agreement by a
competent tribunal or such disclosures are required by law, regulation, or stock exchange rules,
except that such Party will make all reasonable efforts to limit any disclosure as may be required
in the course of legal proceedings by entry of an appropriate protective and confidentiality order,
and will provide the other Party with as much advance notice of such circumstances as is
practicable.
7. Term and Termination
7.1 Term. The term of this Agreement (the “Term”) will commence as of the Effective Date and
will expire on a country-by-country basis upon the later of: (i) expiration of the last-to-expire
Valid Claim in the Enzon Licensed Technology in such country, and (ii) expiration of the Royalty
Term in such country; provided, however, that if no first commercial sale has
occurred as of the date 15 years after the Effective Date, then this Agreement will expire
automatically upon such date.
7.2 Termination for Material Breach.
7.2.1 Any material failure by a Party to comply with any of its material obligations contained
herein (“Default”) will entitle the Party not in default to give to the Party
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in Default written notice specifying the nature of the Default, requiring the defaulting Party
to make good or otherwise cure such Default.
7.2.2 If such Default is not cured within [***]s after the receipt of notice pursuant to
section 7.2.1 above (or, if such Default cannot be cured within such [***] period, if the Party in
Default does not commence actions to cure such Default within such [***] period and thereafter
diligently continue such actions or if such Default is not otherwise cured within [***] after the
receipt of such notice, except in the case of a payment Default, as to which the defaulting Party
will have only a [***] cure period), the Party not in Default will be entitled, on written notice
to the other Party and without prejudice to any of its other rights conferred on it by this
Agreement to seek a determination by a court of competent jurisdiction, in accordance with the
procedures set forth in section 10.4 hereof, that such Default constitutes a material breach of
this Agreement for which termination of this Agreement is authorized by law (such determination a
“Finding of Justifiable Termination”).
7.2.3 Upon a Finding of Justifiable Termination, the Party not in default will be entitled, in
addition to any other remedies available to it by law or in equity, to terminate this Agreement,
unless the breaching Party has cured such Default within [***] after delivery of the Finding of
Justifiable Termination.
7.3 Consequences of Expiration and Termination.
7.3.1 For Material Breach. Upon termination of this Agreement by Enzon pursuant to section
7.2, all licenses granted by Enzon to Micromet under this Agreement will terminate (except as
provided in section 7.3.2).
7.3.2 Survival of Certain Sublicenses. Sublicenses granted by Micromet to a Third Party will
survive termination of Micromet’s license under section 7.3.1 provided that (a) such Third Party is
not the cause of the Default, (b) such Third Party is not in breach of, and continues to fully
perform all obligations under, its sublicense agreement, and (c) Micromet causes such Third Party
to, and such Third Party does, pay directly to Enzon the amounts to which Enzon is entitled under
this Agreement with respect to such Third Party’s Exploitation of Licensed Products.
7.3.3 Obligations Continue. Expiration or termination of this Agreement will not relieve the
Parties of any obligation accruing prior to such expiration or termination. The provisions of
sections 2.1.2, 2.1.3, 3.2.4 to 3.2.7, 5.2, 6 (except 6.6), 7.3, 8, 9 and 10 will survive
termination or expiration of this Agreement.
7.3.4 Know-How License. Upon expiration of this Agreement pursuant to Section 7.1, Micromet
will have a non-exclusive, worldwide, irrevocable, perpetual, fully paid-up license, with the right
to sublicense through multiple tiers of sublicenses, under the Enzon GM-CSF Know-How to Exploit
Licensed 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. |
12
8. Indemnification and Insurance
8.1 Indemnification of Enzon. Micromet will indemnify Enzon, its Affiliates, and their
respective directors, officers, employees and agents, and defend and save each of them harmless,
from and against any and all Losses by Third Parties arising from or occurring as a result of or in
connection with Exploitation by Micromet of Licensed Products hereunder, including any claims of
Curis, Inc. for payment of license fees or royalties in connection with such Exploitation.
8.2 Indemnification Procedure.
8.2.1 Notice of Claim. The indemnified Party will give the indemnifying Party (the
“Indemnifying Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or
discovery of fact upon which such Indemnified Party intends to base a request for indemnification
under section 8.1, but in no event will the Indemnifying Party be liable for any Losses that result
from any delay in providing such notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent that the nature and
amount of such Loss are known at such time). The indemnified Party will furnish promptly to the
Indemnifying Party copies of all papers and official documents received in respect of any Losses.
All indemnification claims in respect of a Party, its Affiliates or their respective directors,
officers, employees and agents (collectively, the “Indemnitees” and each an “Indemnitee”) will be
made solely by such Party to this Agreement (the “Indemnified Party”).
8.2.2 Third Party Claims. The obligations of an Indemnifying Party under this section 8 with
respect to Losses arising from claims of any Third Party that are subject to indemnification as
provided for in section 8.1 (a “Third Party Claim”) will be governed by and be contingent upon the
following additional terms and conditions:
(a) Control of Defense.
(i) At its option, the Indemnifying Party may assume the defense of any Third Party Claim by
giving written notice to the Indemnified Party within 30 days after the Indemnifying Party’s
receipt of an Indemnification Claim Notice.
(ii) Upon assuming the defense of a Third Party Claim, the Indemnifying Party may appoint as
lead counsel in the defense of the Third Party Claim any legal counsel selected by the Indemnifying
Party. In the event the Indemnifying Party assumes the defense of a Third Party Claim, the
Indemnified Party will immediately deliver to the Indemnifying Party all original notices and
documents (including court papers) received by any Indemnitee in connection with the Third Party
Claim. Should the Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying
Party will not be liable to the Indemnified Party or any other Indemnitee for any legal expenses
subsequently incurred by such Indemnified Party or other Indemnitee in connection with the
analysis, defense or settlement of the Third Party Claim.
(b) Right to Participate in Defense. Without limiting section 8.2.2(a), any Indemnitee will
be entitled to participate in, but not control, the defense of such Third Party Claim and to employ
counsel of its choice for such purpose; provided, however, that
13
such employment will be at the Indemnitee’s own expense unless (i) the employment thereof has
been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party
has failed to assume the defense and employ counsel in accordance with section 8.2.2(a) (in which
case the Indemnified Party will control the defense).
(c) Settlement. With respect to any Losses relating solely to the payment of money damages in
connection with a Third Party Claim and that will not result in the Indemnitee’s becoming subject
to injunctive or other relief or otherwise adversely affect the business of the Indemnitee in any
manner, and as to which the Indemnifying Party will have acknowledged in writing the obligation to
indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole right to consent to
the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such
terms as the Indemnifying Party, in its sole discretion, will deem appropriate, and will transfer
to the Indemnified Party all amounts which said Indemnified Party will be liable to pay prior to
the time prior to the entry of judgment. With respect to all other Losses in connection with Third
Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim in
accordance with section 8.2.2(a), the Indemnifying Party will have authority to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such Loss provided it
obtains the prior written consent of the Indemnified Party (which consent will be at the
Indemnified Party’s sole and absolute discretion). The Indemnifying Party will not be liable for
any settlement or other disposition of a Loss by an Indemnitee that is reached without the written
consent of the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend
or prosecute any Third Party Claim, no Indemnitee will admit any liability with respect to, or
settle, compromise or discharge, any Third Party Claim without the prior written consent of the
Indemnifying Party.
(d) Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party will, and will cause each other Indemnitee to,
cooperate in the defense or prosecution thereof and will furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings,
trials and appeals as may be reasonably requested in connection therewith. Such cooperation will
include access during normal business hours afforded to the Indemnifying Party to, and reasonable
retention by the Indemnified Party of, records and information that are reasonably relevant to such
Third Party Claim, and making Indemnitees and other employees and agents available on a mutually
convenient basis to provide additional information and explanation of any material provided
hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection therewith.
8.3 Expenses. Except as provided above, the reasonable and verifiable costs and expenses,
including fees and disbursements of counsel, incurred by the Indemnified Party in connection with
any claim will be reimbursed on a calendar quarter basis by the Indemnifying Party, without
prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.
8.4 Insurance. Each Party will have and maintain such types and amounts of liability
insurance as is normal and customary in the industry generally for parties similarly situated, and
14
will upon request provide the other Party with a copy of its policies of insurance in that
regard, along with any amendments and revisions thereto.
9. Limitation of Liability
IN NO EVENT WILL EITHER PARTY BE LIABLE FOR LOST PROFITS, LOSS OF DATA, OR FOR ANY SPECIAL,
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY
AND WHETHER OR NOT SUCH PARTY HAD OR SHOULD HAVE HAD KNOWLEDGE, ACTUAL OR CONSTRUCTIVE, OF THE
POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF THIS
AGREEMENT. THE FOREGOING LIMITATIONS WILL NOT APPLY TO AN AWARD OF ENHANCED DAMAGES AVAILABLE
UNDER THE PATENT LAWS FOR WILLFUL PATENT INFRINGEMENT AND WILL NOT LIMIT EITHER PARTY’S INDEMNITY
OBLIGATIONS TO THE OTHER PARTY UNDER THIS AGREEMENT. The foregoing limitations on liability and
exclusions of damages: (a) are a fundamental element of the basis of the bargain between the
Parties and this Agreement would not be entered into without such limitations and exclusions; and
(b) shall apply notwithstanding any failure of essential purpose of any limited remedy herein.
10. Miscellaneous
10.1 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by Enzon are, and will otherwise be deemed to be, for purposes of Section 365(n) of the
United States Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Section 101 of the United States Bankruptcy Code. The Parties agree that Micromet, as licensee of
such rights under this Agreement, will retain and may fully exercise all of their rights and
elections under the United States Bankruptcy Code. The Parties further agree that, in the event of
the commencement of a bankruptcy proceeding by or against Enzon under the United States Bankruptcy
Code, Micromet will be entitled to a complete duplicate of (or complete access to, as appropriate)
any such intellectual property and all embodiments of such intellectual property, which, if not
already in Micromet’s possession, will be promptly delivered to it (a) upon any such commencement
of a bankruptcy proceeding upon Micromet’s written request therefore, unless Enzon continues to
perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above,
following the rejection of this Agreement by or on behalf of Enzon upon written request therefore
by Micromet.
10.2 Assignment. Without the prior written consent of the other Party hereto (which such
consent may be granted, withheld or conditioned at the other Party’s sole and absolute discretion),
neither Party will sell, transfer, assign, delegate, pledge or otherwise dispose of, whether
voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights
or duties hereunder; provided, however, that either Party hereto may assign or
transfer this Agreement or any of its rights or obligations hereunder without the consent of the
other Party (a) to any Affiliate of such Party; or (b) to any Third Party with which it merges or
consolidates, or to which it transfers all or substantially all of its assets to which this
Agreement relates. The assigning Party (except if it is not the surviving entity) will remain
jointly and severally liable with the relevant Affiliate or Third Party assignee under this
Agreement, and the relevant
15
Affiliate assignee, Third Party assignee or surviving entity will assume in writing all of the
assigning Party’s obligations under this Agreement. Any purported assignment or transfer in
violation of this section will be void ab initio and of no force or effect.
10.3 Severability. If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any present or future law, and if the rights or obligations of either Party
under this Agreement will not be materially and adversely affected thereby, (a) such provision will
be fully severable, (b) this Agreement will be construed and enforced as if such illegal, invalid
or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this
Agreement will remain in full force and effect and will not be affected by the illegal, invalid or
unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid or
unenforceable provision, there will be added automatically as a part of this Agreement a legal,
valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable
provision as may be possible and reasonably acceptable to the Parties herein. To the fullest
extent permitted by applicable law, each Party hereby waives any provision of law that would render
any provision prohibited or unenforceable in any respect.
10.4 Governing Law; Dispute Resolution.
10.4.1 This Agreement, its interpretation and construction, and any controversy, claim or
dispute between the Parties related to or arising out of this Agreement (each a “Dispute”),
including any Dispute relating to the Parties’ relationship created hereby, the negotiations for
and entry into this Agreement, its conclusion, binding effect, amendment, coverage, or termination,
or the performance or alleged non-performance of a Party of its obligations under this Agreement
will be governed by the laws of the State of New York applicable to contracts made and wholly
performed within such jurisdiction by residents of such jurisdiction and without reference to its
choice of law principles.
10.4.2 The Parties will try to settle any Dispute amicably between themselves. In the event
of a Dispute, a Party may notify the other Party in writing of such Dispute. If the Parties are
unable to resolve the Dispute within [***] of receipt of the written notice by the other Party,
such dispute will be referred to the [***] who will use their good faith efforts to resolve the
Dispute within [***] after it was referred to the [***].
10.4.3 If a Dispute is not resolved [***] pursuant to section 10.4.2, either Party may bring
an action in the federal courts or State courts located in New York County, State of New York,
which will have exclusive jurisdiction (without prejudice to the right to seek removal to federal
courts) over any such Disputes. The Parties submit to the personal jurisdiction of such courts for
any such action, agree that such courts provide a convenient forum for any such action, and waive
any objections or challenges to venue.
10.5 Notices. All notices or other communications that are required or permitted hereunder
will be in writing and delivered personally, sent by facsimile (and promptly confirmed
*** | 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. |
16
by personal delivery or overnight courier as provided herein), or sent by
internationally-recognized overnight courier addressed as follows:
If to Enzon, to:
Enzon Pharmaceuticals, Inc.
000 Xxxxx 000/000
Xxxxxxxxxxx, Xxx Xxxxxx 00000
XXX
Attention: Chief Executive Officer
Facsimile: (000) 000-0000
000 Xxxxx 000/000
Xxxxxxxxxxx, Xxx Xxxxxx 00000
XXX
Attention: Chief Executive Officer
Facsimile: (000) 000-0000
with a copy to:
Enzon Pharmaceuticals, Inc.
000 Xxxxx 000/000
Xxxxxxxxxxx, XX 00000
Attention: General Counsel
Facsimile: (000) 000-0000
000 Xxxxx 000/000
Xxxxxxxxxxx, XX 00000
Attention: General Counsel
Facsimile: (000) 000-0000
If to Micromet, to:
Micromet AG
Xxxxxxxxxxxxxxxxx 0
00000 Xxxxxx
Xxxxxxx
Attention: Chief Executive Officer
Facsimile: xx00 00 000 000 000
Xxxxxxxxxxxxxxxxx 0
00000 Xxxxxx
Xxxxxxx
Attention: Chief Executive Officer
Facsimile: xx00 00 000 000 000
with a copy to:
Cooley Godward LLP
One Freedom Square
Reston Town Center
00000 Xxxxxxx Xxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxx Xxxxx, Esq.
Facsimile: (000) 000-0000
One Freedom Square
Reston Town Center
00000 Xxxxxxx Xxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxx Xxxxx, Esq.
Facsimile: (000) 000-0000
or to such other address as the Party to whom notice is to be given may have furnished to the other
Party in writing in accordance herewith. Any such communication will be deemed to have been given
(i) when delivered, if personally delivered or sent by facsimile on a business day, and (ii) on the
second business day after dispatch, if sent by internationally-recognized overnight courier. It is
understood and agreed that this section 10.5 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.
17
10.6 Entire Agreement; Modifications. This Agreement sets forth and constitutes the entire
agreement and understanding between the Parties with respect to the subject matter hereof and all
prior agreements, understanding, promises and representations, whether written or oral, with
respect thereto are superseded hereby. Each Party confirms that it is not relying on any
representations or warranties of the other Party except as specifically set forth herein. No
amendment or modification of this Agreement will be binding upon the Parties unless made in writing
and duly executed by authorized representatives of both Parties.
10.7 Relationship of the Parties. It is expressly agreed that the Parties’ relationship under
this Agreement is strictly one of licensor-licensee and that this Agreement does not create or
constitute a partnership, joint venture, or agency. Neither Party will have the authority to make
any statements, representations or commitments of any kind, or to take any action, which will be
binding (or purport to be binding) on the other. All persons employed by a Party will be employees
of such Party and not of the other Party and all costs and obligations incurred by reason of any
such employment will be for the account and expense of such Party.
10.8 Waiver. Any term or condition of this Agreement may be waived at any time by the Party
that is entitled to the benefit thereof, but no such waiver will be effective unless set forth in a
written instrument duly executed by or on behalf of the Party waiving such term or condition. The
waiver by either Party hereto of any right hereunder or of claims based on the failure to perform
or a breach by the other Party will not be deemed a waiver of any other right hereunder or of any
other breach or failure by said other Party whether of a similar nature or otherwise.
10.9 Counterparts. This Agreement may be executed in 2 or more counterparts, each of which
will be deemed an original, but all of which together will constitute one and the same instrument.
10.10 No Benefit to Third Parties. The representations, warranties, covenants and agreements
set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and
permitted assigns, and they will not be construed as conferring any rights on any other parties.
10.11 Further Assurance. Each Party will duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and do and cause to be done such further acts and
things, including the filing of such assignments, agreements, documents and instruments, as may be
necessary or as the other Party may reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes, or to better assure and confirm unto such
other Party its rights and remedies under this Agreement.
10.12 English Language. This Agreement has been written and executed in the English language.
Any translation into any other language will not be an official version thereof, and in the event
of any conflict in interpretation between the English version and such translation, the English
version will control.
10.13 Construction. Except where the context otherwise requires, wherever used, the singular
will include the plural, the plural the singular, the use of any gender will be applicable to
18
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. The language of this Agreement will be deemed to be the language mutually
chosen by the Parties and no rule of strict construction will be applied against either Party
hereto.
10.14 No Stacking of Payments. If a Party has an obligation to make any royalty payments
under this Agreement with respect to a Licensed Product, then the amount of such payments made will
be creditable against any milestone, royalty or profit-sharing payments with respect to the same
product under any other agreement between the Parties.
[Remainder of Page Intentionally Left Blank]
19
In Witness Whereof, the Parties have caused this Agreement to be executed by their
respective authorized representatives as of the date first written above.
Micromet AG
|
Enzon Pharmaceuticals, Inc. | ||
By: /s/ Xxxxxxxxx Xxxx
|
By: /s/ Xxxxxxx X. Xxxxxxxxx | ||
Name: Xxxxxxxxx Xxxx
|
Name: Xxxxxxx X. Xxxxxxxxx | ||
Title: CEO
|
Title: Chairman, President & CEO | ||
By: /s/ Xxxxxx X. Xxxxx |
|||
Name: Xxxxxx X. Xxxxx |
|||
Title: CFO/COO |
[Signature Page to the GM-CSF License Agreement]
APPENDIX A
Enzon Licensed Patents
Application | Application | Patent | Date of | |||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
2.
Application | Application | Patent | Date of | |||||||||
Number | Filing Date | Country | Title of Application | Status | Number | Grant | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***]
|
[***] | [***] | [***] | [***] | ||||||||
[***] |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
3.
APPENDIX B
Field Limitations
The licenses granted under this Agreement will not include the right to exploit 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. |
APPENDIX C
Net Sales and Other Financial Definitions
“Net Sales” means the aggregate amount of gross revenues invoiced by Micromet, and its Affiliates
and its sublicensees from or on account of the sale of product to unaffiliated third parties, less
deductions allowed to customers by Micromet, its Affiliates or sublicensees as the case may be, to
sell such product using generally accepted accounting principles and reasonable practices with
respect to sales of all Micromet’s products, consistently applied, for the following: (a) trade,
cash and quantity discounts or rebates; (b) chargebacks paid to distributors and customers; (c)
credits or allowances, if any, actually granted on account of price adjustments, recalls, rejection
or return of product; (d) payments or rebates paid in respect of any state or federal Medicare,
Medicaid or similar programs of the United States or other governments in connection with sales of
product to any regulatory authority, governmental agency or any third party funded or reimbursed by
Medicare, Medicaid or similar programs of the United States or other governments; (e) excise taxes,
sales taxes, value added taxes, consumption taxes, customs and other duties or other taxes or other
governmental charges imposed upon and paid or allowed with respect to the production, importation,
use or sale of the product (excluding income or franchise taxes of any kind); (f) separately
itemized, insurance, freight or other transportation costs and distribution fees paid to a sole
source distributor for product (such fees not to exceed [***] of the average sales price) incurred
in shipping product to such third parties; and (g) any write-offs for bad debt (collectively, the
“Permitted Deductions”). No deduction will be made for any item of cost incurred by Micromet, its
Affiliates or sublicensees in preparing, shipping or selling product except as permitted pursuant
to the foregoing clauses (a) through (g) inclusive. Net Sales will not include any transfer between
any of Micromet and any of its Affiliates or sublicensees for resale, but Net Sales will include
the subsequent final sales to unaffiliated third parties by such Affiliates or sublicensees. Fair
Market Value will be assigned to any and all non-cash consideration such as but not limited to any
credit, barter, benefit, advantage or concession received by Micromet or its Affiliates or
sublicensees in payment for sale of product. As used in this definition, a “sale” has occurred when
Micromet, an Affiliate or sublicensee recognizes revenue for such sale according to U.S. GAAP (or
such other accounting principles as may be applicable to Micromet, such Affiliate or sublicensee).
Notwithstanding anything herein to the contrary, the following will not be considered a sale of
product under this Agreement: (i) the transfer of a product to a third party without consideration
in connection with the development or testing of a product; or (ii) the transfer of a product to a
third party without consideration in connection with the marketing or promotion of the product
(e.g., pharmaceutical samples). Notwithstanding the foregoing, in calculating Net Sales, no
deductions from gross revenues that are not permitted by U.S. GAAP (or such other accounting
principles as may be applicable to the Party, Affiliate or sublicensee) to be deducted for the
purposes of such calculation will be deducted.
“Fair Market Value” means the price at which the property would change hands between a willing
buyer and a willing seller, neither being under any compulsion to buy or to sell and both having
reasonable knowledge of relevant facts. For stock that can be bought or sold on an
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established securities market, or through some other system that acts as the equivalent of a
securities market, the Fair Market Value is the average of the high and low selling prices on the
date on which a Party receives or transfers such stock. For not publicly traded stock, the Fair
Market Value is the value of the stock in the last arm’s length sale to an independent, unrelated
Third Party occurring in the 6 months preceding that date, or if no such sale has occurred, the
value as determined by the board of directors of the receiving or transferring Party. If the other
Party disagrees with the determination by the board of directors, such Party will have the right to
dispute such determination and resolve such dispute in accordance with the dispute resolution
procedures set forth in the Agreement.
2.