EXHIBIT 10.34
COLLABORATION AGREEMENT
This Agreement is entered into as of June 14, 2005 by and between
SEATTLE GENETICS, INC
., a Delaware corporation, having its principal place of business at 21823 30th Drive S.E., Bothell, Washington 98021 (hereinafter referred to as “
SGI
”), and
PSMA DEVELOPMENT COMPANY LLC
, a Delaware limited liability corporation, having its principal place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591 (hereinafter referred to as “
Licensee
”).
WITNESSETH
WHEREAS
, SGI Controls (as defined below) intellectual property rights relating to certain technology useful for linking certain proprietary [*] to other molecules, such as antibodies, capable of directing such [*] to specific tissues and/or cells;
WHEREAS
, Licensee Controls intellectual property rights relating to the Designated Antigen (as defined below), and is currently conducting research and development relating to Antibodies (as defined below) that bind to the Designated Antigen pursuant to a Research Collaboration Agreement dated [*], as amended (the “
Research Collaboration Agreement
”); and
WHEREAS
, Licensee wishes to acquire from SGI, and SGI wishes to grant to Licensee, an exclusive, worldwide license under SGI patent rights and know-how related to SGI’s proprietary [*] for use in conjunction with such Antibodies for the development, commercialization, manufacture, marketing and sale of Licensed Products (as defined below).
NOW, THEREFORE
, in consideration of the mutual covenants and obligations set forth herein, the Parties hereto, intending to be legally bound, agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATION
1.1
Definitions
: For the purposes of this Agreement the following words and phrases shall have the following meanings:
1.1.1
“
AAA
” has the meaning set forth in Section 19.3.4.
1.1.2
“
ADC
” or “
Antibody-Drug Conjugate
” means an Antibody
[*]
and that contains, uses or is made using SGI Technology.
1.1.3
“
ADC Access Fee
” has the meaning set forth in Section 6.1.1.
1.1.4
“
Adverse Drug Experience
” shall mean any “adverse experience” as defined or contemplated by 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.5
“
Affiliate
” of a Party means any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with a Party. As used herein, the term “control” means the direct or indirect ownership of
[*]
or more of the stock having the right to vote for directors thereof or the ability to otherwise control the management thereof. For purposes of clarification, each of Progenics Pharmaceuticals, Inc. (“
Progenics
”) and Cytogen Corporation (“
Cytogen
”) shall be deemed an Affiliate of Licensee so long as their respective
[*]
.
1.1.6
“
Agreement
” means this agreement, all duly executed amendments and supplements to this Agreement and all schedules to this Agreement, including the following:
Schedule A
- Research Plan.
Schedule B
- SGI Patents.
Schedule C
- SGI In-Licenses.
1.1.7
“
Antibody
” or “
Antibodies
” means any molecule that binds specifically to an Antigen, including, but not limited to,
[*]
.
1.1.8
“
Antigen
” means any molecule that will induce an
[*]
, including but not limited to a
[*]
.
1.1.9
“
[*]
” means the SGI Technology licensed to SGI under the
[*]
Agreement (as defined in the definition of “
SGI In-Licenses
”).
1.1.10
“
Breaching Party
” has the meaning set forth in Section 13.3.
1.1.11
“
Calendar Quarter
” means any of the three-month periods beginning January 1, April 1, July 1 and October 1 in any year.
1.1.12
“
Combination Product
” means any Licensed Product that contains, in
[*]
.
1.1.13
“
Commercially Reasonable Efforts
” means, with respect to a Party, the efforts and resources typically used by biotechnology companies similar in size and scope to such Party to perform the obligation at issue; in each case with respect to a product or potential product of similar nature at a similar stage in its development or product life and of similar market potential, in view of conditions prevailing at the time, and evaluated taking into account all relevant factors, including without limitation, the mechanism of action, efficacy, safety, the anticipated regulatory authority approved labeling, the competitiveness of alternative products that are in the marketplace or under development, the patent and other proprietary position of the product, the likelihood of Regulatory Approval, the profitability of the product and other technical, scientific, legal, medical, marketing and competitive factors.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.14
“
Confidential Information
” has the meaning set forth in Section 8.1.
1.1.15
“
Control
” means, with respect to any information or intellectual property right, possession by a Party of the ability to grant the right to access or use, or to grant a license or a sublicense to, such information or intellectual property right without violating the terms of any agreement or other arrangement with any Third Party. In the case of an Antigen, such Antigen will be deemed to be Controlled by Licensee if Licensee Controls
[*]
.
1.1.16
“
Cost of Goods
” shall mean with respect to Drug Conjugation Materials or ADCs supplied to Licensee by SGI: (a) for manufacturing activities performed by Third Parties, SGI’s reasonably documented out-of-pocket costs actually incurred in such manufacture and supply of Drug Conjugation Materials or ADCs, as well as SGI’s reasonable internal costs incurred in supporting the Third Party manufacturing relationship, including without limitation
[*]
; and (b) for manufacturing activities performed by SGI or its Affiliates, the consolidated fully burdened cost of manufacturing such Drug Conjugation Materials or ADCs, which shall mean costs of the following as such costs are actually incurred by SGI or its Affiliates:
[*]
, and as determined in accordance with GAAP as consistently applied by SGI.
1.1.17
“
Designated Antigen
” means the PSMA Antigen having a GenBank Accession No.
[*]
.
1.1.18
“
Disclosing Party
” has the meaning set forth in Section 8.1.
1.1.19
“
Drug Conjugation Materials
” means the
[*]
and certain
[*]
, as well as other compounds that are useful in attaching such compounds to
[*]
. Drug Conjugation Materials shall also include SGI Inventions to the foregoing, and shall also include any additional
[*]
compound or other compounds that are useful in attaching compounds to Antibodies and that are included in New Technologies that the Parties agree to include under this Agreement pursuant to Section 3.3.
1.1.20
“
Effective Date
” means the date set forth in the first line of this Agreement.
1.1.21
“
Events of Force Majeure
” has the meaning set forth in Article 15.
1.1.22
“
Exclusive License
” has the meaning set forth in Section 3.1.
1.1.23
“
Exclusive License Renewal Fee
” has the meaning set forth in Section 6.2.
1.1.24
“
Existing Third Party Royalties
” has the meaning set forth in Section 6.4.3.
1.1.25
“
Extended Research Program Term
” has the meaning set forth in Section 2.2.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.26
“
FD&C Act
” means the federal Food, Drug & Cosmetic Act, as amended.
1.1.27
“
FDA
” means the United States Food and Drug Administration and its subdivisions, and any successor agency thereto.
1.1.28
“
Field
” means the
[*]
.
1.1.29
“
First Commercial Sale
” means, in each country of the Territory, the first commercial sale of a Licensed Product by Licensee, its Affiliates or Sublicensees to a Third Party following, if required by law, Regulatory Approval and, when Regulatory Approval is not required by law, the first commercial sale in that country, in each case for use or consumption of such Licensed Product in such country by the general public.
1.1.30
“
Former Designated Antigen
” has the meaning set forth in Section 3.6.
1.1.31
“
FTE
” means a full time equivalent person year, based upon a total of
[*]
.
1.1.32
“
GAAP
” means generally accepted accounting principles in the United States.
1.1.33
“
Generic Version
” means, with respect to a Licensed Product in a
[*]
and (ii)
[*]
.
1.1.34
“
Good Clinical Practices
” means the standards, practices and procedures set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA, any successor agency and, as applicable, the equivalent thereof in jurisdictions outside the United States.
1.1.35
“
Good Laboratory Practices
” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the United States.
1.1.36
“
Good Manufacturing Practices
” means the then-current good manufacturing practices required by the FDA and set forth in the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, for the manufacturing and testing of pharmaceutical materials, and any other laws or regulations applicable to the manufacturing and testing of pharmaceutical materials in jurisdictions outside the United States.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.37
“
IND
” means (a) an Investigational New Drug Application filed with the FDA or its equivalent in any country outside the United States where a regulatory filing is required or obtained to conduct a clinical trial; or (b) with respect to any country where a regulatory filing is not required or obtained to conduct a clinical trial, the first enrollment of a patient in the first trial involving the first use of a Licensed Product in humans.
1.1.38
“
Indemnitee
” has the meaning set forth in Section 14.3.1.
1.1.39
“
Indemnitor
” has the meaning set forth in Section 14.3.1.
1.1.40
“
Initial Research Program Term
” has the meaning set forth in Section 2.2.
1.1.41
“
Initiation
” means, with respect to a human clinical trial, the dosing of the first patient with a Licensed Product pursuant to the clinical protocol for the specified clinical trial.
1.1.42
“
Inventions
” means any patentable or non-patentable inventions, discoveries or other know-how discovered, created or developed and Controlled by either Party that arise out of activities conducted under this Agreement or the Research Collaboration Agreement; provided that Inventions shall not include any
[*]
.
1.1.43
“
Joint Inventions
” has the meaning set forth in Section 9.1.2(c).
1.1.44
“
Joint Patents
” has the meaning set forth in Section 9.2.2.
1.1.45
“
Licensed Product
” means any and all products containing an ADC comprised of an Antibody that binds to the Designated Antigen.
1.1.46
“
Licensee
” has the meaning set forth in the first paragraph of this Agreement. Each reference to “Licensee” shall, where appropriate, be deemed to include applicable “Sublicensees”.
1.1.47
“
Licensee ADC Know-How
” means all technical information, processes, formulae, data, inventions, methods, chemical compounds, biological or physical materials, know-how and trade secrets Controlled by Licensee, in each case that are not in the public domain, that are developed by Licensee using SGI Technology, and that relate to or are useful in identifying, developing, making, using or selling
[*]
.
1.1.48
“
Licensee ADC Patents
” means all patent applications and patents that are Controlled by Licensee that claim inventions made using SGI Technology, which inventions are for identifying, developing, making, using or selling
[*]
.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.49
“
Licensee Know-How
” means all technical information, processes, formulae, data, inventions, methods, chemical compounds, biological or physical materials, know-how and trade secrets Controlled by Licensee, in each case that are not in the public domain, that relate to or are useful in (a)
[*]
, or (b)
[*]
.
1.1.50
“
Licensee Indemnified Parties
” has the meaning set forth in Section 14.2.
1.1.51
“
Licensee Invention Patents
” has the meaning set forth in Section 9.3.3.
1.1.52
“
Licensee Inventions
” has the meaning set forth in Section 9.1.2(a).
1.1.53
“
Licensee Patents
” means all patent applications and patents that are Controlled by Licensee that claim (a)
[*]
, or (b)
[*]
.
1.1.54
“
Losses
” has the meaning set forth in Section 14.1.
1.1.55
“
Net Sales
” means, as to each calendar quarter, the gross invoiced sales prices charged for all Licensed Products sold by or for Licensee, its Affiliates and Sublicensees to independent Third Parties during such quarter,
[*]
with respect to sales of Licensed Products:
(a)
[*]
;
(b)
[*]
;
(c)
[*]
; and
(d)
[*]
.
All of the foregoing [*] shall be determined in accordance with GAAP. In the event that Licensee, its Affiliates or Sublicensees make any adjustments to such [*] have been reported pursuant to this Agreement, the adjustments shall be reported and reconciled in the next report and payment of any royalties due.
In the event a Licensed Product is sold as part of a [*]
during the applicable royalty reporting period, by the
[*]
in each case during the applicable royalty reporting period or, if sales of the Licensed Product [*]
did not occur in such period or country, then in the most recent royalty reporting period in which [*] Licensed Product occurred in such country or if no such sales have occurred in such country, the [*]
during the applicable royalty period. In the event that such [*].
1.1.56
“
New Technologies
” means any
[*]
(i) that are
[*]
Controlled by SGI, or (ii) that are first developed by SGI after the Effective Date and that are
[*]
, including but not limited to the chemical compositions and the methods useful for
[*]
.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.57
“
Notice of Dispute
” has the meaning set forth in Section 19.3.1.
1.1.58
“
Parties
” means Licensee and SGI, and “Party” means either of them.
1.1.59
“
Person
” means a natural person, a partnership, a corporation, an association, a joint stock company, a limited liability company, a trust, a joint venture or an unincorporated organization.
1.1.60
“
Personnel Fees
” has the meaning set forth in Section 6.1.2.
1.1.61
“
Phase I Clinical Trial
” means a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients.
1.1.62
“
Phase II Clinical Trial
” means a controlled dose clinical trial prospectively designed to evaluate the efficacy and safety of a candidate drug in the targeted patient population and to define the optimal dosing regimen.
1.1.63
“
Phase III Clinical Trial
” means a controlled, and usually multi-center, clinical trial, involving patients with the disease or condition of interest to obtain sufficient efficacy and safety data to support Regulatory Approval of a candidate drug.
1.1.64
“
Publication
” has the meaning set forth in Section 8.5.
1.1.65
“
Receiving Party
” has the meaning set forth in Section 8.1.
1.1.66
“
Regulatory Approval
” means final regulatory approval (including, where applicable, pricing approval in the event that actual sales do not take place before such approval) required to market a Licensed Product for a disease or condition in accordance with the applicable laws and regulations of a given country. In the United States, its territories and possessions, Regulatory Approval means approval of a New Drug Application (“
NDA
”), Biologics License Application (“
BLA
”) or an equivalent by the FDA.
1.1.67
“
[*]
” has the meaning set forth in Section 3.6.
1.1.68
“
Replacement Antigen Fee
” has the meaning set forth in Section 3.6.
1.1.69
“
Reports
” has the meaning set forth in Section 7.1.1.
1.1.70
“
Research Fees
” has the meaning set forth in Section 6.1.2.
1.1.71
“
Research Fees Report
” has the meaning set forth in Section 6.1.2.
1.1.72
“
Research Plan
” means the plan for the Research Program agreed upon by the Parties and attached hereto as
Schedule A
.
1.1.73
“
Research Program
” means the research program conducted pursuant to Article 2.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.74
“
Research Program Term
” means the term of the Research Program set forth in Section 2.2.
1.1.75
“
Royalty Term
” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the later to occur of: (a) the tenth
anniversary of the date of First Commercial Sale of the Licensed Product in such country; or (b) the expiration of the last to expire Valid Patent Claim that would be infringed by the sale of the Licensed Product in such country, if not for the licenses granted hereunder.
1.1.76
“
Serious Adverse Drug Experience
” shall mean any Adverse Drug Experience that is fatal or life-threatening, is permanently disabling, requires in-patient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability or incapacity, or is a congenital anomaly, or overdose, or other event which would constitute a “serious” adverse experience pursuant to the terms of 21 C.F.R. § 312.32 or 21 C.F.R. §314.80.
1.1.77
“
SGI Indemnified Parties
” has the meaning set forth in Section 14.1.
1.1.78
“
SGI In-Licenses
” means the following agreements between SGI and the indicated Third Parties: (a) [*]; (b) [*]; and (c) [*].
1.1.79
“
SGI Inventions
” has the meaning set forth in Section 9.1.2(b).
1.1.80
“
SGI Know-How
” means all technical information, processes, formulae, data, inventions, methods, chemical compounds, biological or physical materials, know-how and trade secrets Controlled by SGI, in each case that are not in the public domain, that relate to or are useful in the discovery, research, development, manufacture or use of Drug Conjugation Materials or ADCs for purposes of the offer and sale of Licensed Products in the Field, including but not limited to the chemical compositions and the methods useful for attaching the Drug Conjugation Materials to Antibodies. SGI Know-How shall exclude any
[*]
.
1.1.81
“
SGI Patents
” means:
(a)
any patents and patent applications listed in
Schedule B
to this Agreement (each, an “
Existing SGI Patent
”), which shall be amended from time to time to add any other patents and patent applications which shall be included as SGI Patents;
(b)
any patents and patent applications covering SGI Know-How or SGI Inventions and, solely to the extent the parties so agree pursuant to
[*]
, and
Schedule B
to this Agreement shall be amended from time to time to add patents or patent applications that arise from any of the foregoing;
(c)
any future patents issued from any patent applications referred to above and any future patents issued from any continuation, continuation-in-part (to the extent Controlled by SGI), divisional or provisional of any of the foregoing patent applications or any patent applications from which the foregoing patents issued; and
(d)
any reissues, reexaminations, confirmations, renewals, registrations, substitutions, extensions, or counterparts of any of the foregoing.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.1.82
“
SGI Technology
” means the SGI Patents, the Drug Conjugation Materials, the SGI Know-How, SGI’s rights in the Joint Inventions and the SGI Inventions. For purposes of clarification, SGI Technology shall include, without limitation, the technology comprising
[*]
in each case as set forth on Schedule B, or as may otherwise be identified as an SGI In-License pursuant to Section 1.1.78.
1.1.83
“
Sublicensees
” means any person or entity that is granted a sublicense under the SGI Technology by Licensee or its Affiliates in accordance with the terms of this Agreement.
1.1.84
“
Supply Fees
” has the meaning set forth in Section 5.3.
1.1.85
“
Term
” has the meaning set forth in Article 13.
1.1.86
“
Territory
” means all countries in the world.
1.1.87
“
Third Party
” means any person or entity other than Licensee, SGI and their respective Affiliates.
1.1.88
“
Third Party Claim
” has the meaning set forth in Section 14.1.
1.1.89
“
Valid Patent Claim
” means a claim (a) of any issued and unexpired SGI Patent (as applicable) which has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) of any patent application contained in the SGI Patents (as applicable) which shall not have been pending on or after the
[*]
of the date of issuance of a first patent office communication during examination of the first application related thereto (in the relevant country), and shall not have been earlier cancelled, withdrawn or abandoned, and, on a country-by-country basis, which is enforceable on the operative date of inquiry by virtue of applicable law in such country.
1.2
Certain Rules of Interpretation in this Agreement and the Schedules
.
1.2.1
Unless otherwise specified, all references to monetary amounts are to United States of America currency (U.S. Dollars);
1.2.2
The preamble to this Agreement and the descriptive headings of Articles and Sections are inserted solely for convenience of reference and are not intended as complete or accurate descriptions of the content of this Agreement or of such Articles or Sections;
1.2.3
The use of words in the singular or plural, or with a particular gender, shall not limit the scope or exclude the application of any provision of this Agreement to such person or persons or circumstances as the context otherwise permits;
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
1.2.4
The words “include” and “including” have the inclusive meaning frequently identified with the phrases “without limitation” and “but not limited to”;
1.2.5
Unless otherwise specified, time periods within or following which any payment is to be made or act is to be done shall be calculated by excluding the day on which the period commences and including the day on which the period ends and by extending the period to the next business day following if the last day of the period is not a business day in the jurisdiction of the Party to make such payment or do such act; and
1.2.6
Whenever any payment is to be made or action to be taken under this Agreement is required to be made or taken on a day other than a business day, such payment shall be made or action taken on the next business day following such day to make such payment or do such act.
ARTICLE 2
RESEARCH PROGRAM
2.1
Objective and Conduct of the Research Program
. Licensee intends to conduct a Research Program, with SGI’s support, to evaluate ADCs for commercial development under this Agreement. Licensee acknowledges that, in addition to the licenses to the SGI Patents granted hereunder, the SGI Know-How transferred to Licensee under this Agreement contains valuable information that is critical to Licensee’s development of ADCs hereunder. SGI’s research activities hereunder which are designated by Licensee to be used in support of regulatory filings will be performed in a good scientific manner, consistent with Good Laboratory Practices. SGI shall deliver to Licensee a report summarizing the results of such research activities within
[*]
of the end of any calendar quarter in which such research activities were conducted.
2.2
Term of the Research Program
. The initial term of the Research Program shall be for a period of
[*]
after the Effective Date (the “
Initial Research Program Term
”),
[*];
provided, however, that, upon notice and payment to SGI of
[*]
, Licensee may renew (prior to the end of Initial Research Program Term) the Research Program for an
[*]
(the “
Extended Research Program Term
”, and together with the Initial Research Program Term, the “
Research Program Term
”).
2.3
SGI Preparation of ADCs
. SGI will prepare, in accordance with the procedures set forth in the Research Plan, such research quantities of ADCs as may be reasonably requested by Licensee using Antibodies supplied by Licensee to SGI and Drug Conjugation Materials manufactured by SGI, or by or on behalf of Licensee, and shall deliver the resulting ADCs to Licensee in accordance with the reasonable timelines requested by Licensee (or as otherwise set forth in the Research Plan). SGI will also provide Licensee, in accordance with Article 4 and the Research Plan, with
[*]
. All such Drug Conjugation Materials provided by SGI to Licensee hereunder will be deemed Confidential Information of SGI pursuant to Article 8.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
2.4
Payment
. Licensee shall pay SGI the amounts set forth in Section 6.1.2 for any research efforts or other assistance provided by SGI pursuant to Section 2.3.
2.5
Disclaimer
. EXCEPT AS MAY BE OTHERWISE PROVIDED IN ARTICLE 12, NEITHER PARTY MAKES ANY REPRESENTATION OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, REGARDING THE DRUG CONJUGATION MATERIALS, ANTIBODIES, ANTIGENS, ADCs OR LICENSED PRODUCTS, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR USE OR PURPOSE.
ARTICLE 3
EXCLUSIVE LICENSE
3.1
Exclusive License Grant
. Upon payment of the ADC Access Fee set forth in Section 6.1.1, subject to the terms and conditions of this Agreement, SGI shall be automatically deemed to grant to Licensee a worldwide, exclusive (even as to SGI), royalty-bearing license under the SGI Technology, with the right to sublicense as permitted in Section 3.2, to discover, research, develop, make, have made, import, have imported and use, Licensed Products in the Field and Drug Conjugation Materials for the offer and sale of Licensed Products in the Field in the Territory (the “
Exclusive License
”). The Exclusive License shall continue for the Royalty Term, unless earlier terminated pursuant to Article 13, subject to payment of applicable milestones, royalties and the Exclusive License Renewal Fees set forth in Section 6.2.
3.2
Rights to Sublicense
.
3.2.1
Licensee shall have the right to grant sublicenses of the rights granted to Licensee pursuant to this Agreement to any Affiliate or any Third Party, subject to the restrictions contained in this Section 3.2 and the requirements of Section 3.4. Licensee shall not have the right to sublicense the SGI Technology outside the scope of the license granted in Section 3.1, including to develop further Drug Conjugation Materials on a stand alone basis or to create ADCs that include or are based upon any Antibodies that do not bind to the Designated Antigen or Replacement Antigen, if any.
3.2.2
Licensee agrees that it shall have responsibility to make payments to SGI for the achievement of any milestones set forth in Section 6.5 by its Sublicensee(s), and to pay royalties on Net Sales of any Licensed Products by any such Sublicensee(s) pursuant to Section 6.3 (subject to reduction in accordance with Section 6.4). In addition, Licensee shall be responsible for the compliance by its Sublicensee(s) with all terms of this Agreement applicable to Licensee (including all terms of this Agreement identified as applicable to such Sublicensee(s)). Licensee shall also require any such Sublicensee(s) to agree in writing to keep books and records and permit SGI to review the information concerning such books and records in accordance with Section 7.2.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
3.2.3
Licensee shall notify SGI of each sublicense granted to Affiliates or Third Parties and shall provide SGI with the name and address of each Sublicensee and a description of the rights granted and the territory covered by each Sublicensee.
3.3
[*].
The Exclusive License shall extend to
[*]
as follows: SGI shall promptly notify Licensee of any
[*]
to which it obtains rights (with the right to grant sublicenses thereunder) during the Term by providing to Licensee a
[*]
, including all
[*]
under which Licensee would be able to access such
[*]
. If Licensee is interested in practicing such
[*]
, the Parties shall discuss in good faith modifications to this Agreement to reflect the terms governing Licensee’s access to any
[*]
pursuant to this Agreement, which shall include without limitation Licensee’s agreement to
[*]
; provided, however, that in no event shall the costs to Licensee associated with Licensee’s use of such
[*]
exceed the amount of any
[*]
.
3.4
Compliance with the SGI In-Licenses
.
3.4.1
Licensee, its Affiliates and Sublicensees shall comply with all obligations, covenants and conditions of the SGI In-Licenses listed in
Schedule C
(unless such obligations, conditions or covenants have been redacted by SGI in the version of SGI In-License delivered to Licensee), and any amendments thereto following written disclosure thereof to Licensee, to the extent (i) expressly applicable to sublicensees under such SGI In-Licenses, and (ii) technology included within such SGI In-License is being utilized in the Research Program or is incorporated into a Licensed Product. Licensee shall be entitled to all rights expressly provided sublicensees under the terms of the SGI In-Licenses, including but not limited to the rights provided under
[*]
. The Parties agree that BMS
is a Third Party beneficiary to this Agreement to the extent SGI Technology includes BMS
Technology. SGI shall use best efforts to include in each SGI In-License executed after the Effective Date a provision requiring the licensor of such rights to treat Licensee as a direct licensee under the terms of such SGI In-License in the event that such SGI In-License is terminated; provided that Licensee is then in compliance with the terms of such SGI In-License.
3.4.2
SGI shall perform all obligations required to be performed by it under each SGI In-License in accordance with the terms and conditions of each such SGI In-License, and SGI will use its Commercially Reasonable Efforts to maintain each SGI In-License in full force and effect. SGI will not
[*]
. In the event that SGI receives notice of a material breach of any SGI In-License, SGI shall immediately inform Licensee of receipt of such notice.
3.4.3
SGI will not
[*]
any
[*]
to an
[*]
that
[*]
.
3.5
Limited License to SGI
. Subject to the provisions of this Agreement, Licensee hereby grants to SGI, during the Research Program Term, a non-exclusive, royalty-free, nonsublicenseable (except to the extent that the Research Plan provides for the use of a Third Party subcontractor by SGI) license under the Licensee Patents and Licensee Know-How in the Territory, for the sole purpose of enabling SGI to perform its obligations under Article 2 and the Research Plan.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
3.6
[*]
. At any time during the
[*]
, Licensee shall have the right to
[*]
subject to and in accordance with the procedures described below and upon payment of
[*]
. Once the Designated Antigen
[*]
, such Designated Antigen shall be considered the “
Former Designated Antigen
” and (a)
[*]
, and (b)
[*]
; provided, however, that the terms of this Section 3.6 shall not be deemed to grant to SGI any rights in the Licensee Patents, Licensee Know-How, Licensee Inventions, Licensee Invention Patents, or Joint Inventions, beyond the
[*]
. For the avoidance of doubt, the grant of this license is not
[*]
. Thereafter, the
[*]
shall be considered the Designated Antigen for purposes of this Agreement (except, for the limited purpose of the license provided in
[*]
to the extent the Designated Antigen is considered the Former Designated Antigen and this Agreement shall be appropriately amended or modified to establish the
[*]
as the Designated Antigen. The
[*]
, will have no effect on the intellectual property ownership rights of the parties relating to such Designated Antigen as such rights existed on the date of the replacement. In addition, upon designation of the
[*]
.
3.7
Availability of
[*]
. To determine if an Antigen is available to become the
[*]
, Licensee shall provide SGI with a
[*]
, including to the extent available, the
[*]
, which Licensee desires to
[*]
for purposes of this Agreement. Within
[*]
, SGI shall notify Licensee in writing whether the Exclusive License is available with respect to such Antigen. If the Exclusive License is available for such Antigen, such Antigen shall
[*]
. The Parties hereby acknowledge and agree that an Antigen
[*]
(a)
[*]
or (b)
[*]
.
ARTICLE 4
TECHNOLOGY DISCLOSURE
As soon as reasonably practicable following the Effective Date, and from time to time during the Term upon the reasonable request of Licensee, SGI shall deliver to Licensee, in such form as may reasonably be requested by Licensee from time to time, the SGI Know-How as is necessary or reasonably useful to enable Licensee to manufacture or have manufactured and use the Drug Conjugation Materials and the ADCs as provided in this Agreement, including, without limitation, available written or electronic information relating to the [*]. During the Term, upon Licensee’s reasonable request, SGI will provide Licensee, or such Affiliate of Licensee as may be designated by Licensee, with assistance and training regarding the manufacture and/or use of Drug Conjugation Materials and ADCs; provided that if in-person assistance is required, such assistance shall take place upon at least [*]
prior written notice to SGI at SGI’s facilities, unless otherwise mutually agreed upon. Licensee shall pay to SGI for such assistance an amount equal to the Personnel Fees in accordance with Section 6.1.2 for SGI employees providing such assistance.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
ARTICLE 5
DEVELOPMENT AND COMMERCIALIZATION; MANUFACTURING
5.1
Diligence
. Licensee shall use Commercially Reasonable Efforts to develop, commercialize and market Licensed Products. Notwithstanding the foregoing, Licensee shall have
[*]
.
5.2
Funding and Progress Reports
. Except as set forth herein, as between SGI and Licensee, Licensee shall be solely responsible for funding all costs of the development and commercialization of Licensed Products. Beginning on
[*]
, and annually thereafter within
[*]
following the
[*]
, Licensee shall provide SGI with a written report summarizing Licensee’s significant activities related to research and development of Licensed Products and status of clinical trials and applications for Regulatory Approval necessary for marketing Licensed Products. Such reports shall be deemed Licensee’s Confidential Information for the purposes of Article 8.
5.3
Manufacturing
.
5.3.1
Except as otherwise set forth in this Agreement, Licensee shall be responsible for all manufacturing and supply of Licensed Products. Licensee shall pay SGI for
all Drug Conjugation Materials and/or ADCs supplied by SGI to Licensee under Section 2.3 at the
[*]
(the “
Supply Fees
”).
5.3.2
SGI shall, upon request by Licensee (i)
[*]
, and (ii) provide Licensee, or Third Parties manufacturing Drug Conjugation Materials on behalf of Licensee, such assistance related to the manufacture of Drug Conjugation Materials as may reasonably be requested by Licensee pursuant to the terms of Article 4 and the Research Plan. Notwithstanding the foregoing, SGI shall
[*]
.
5.3.3
SGI shall, upon reasonable request by Licensee,
[*]
.
ARTICLE 6
FEES, ROYALTIES AND PAYMENTS
6.1
Research Fees
. Licensee shall pay to SGI the following amounts in consideration of the Research Program:
6.1.1
Within ten (10) days of the Effective Date, Licensee shall pay to SGI the sum of Two Million U.S. Dollars ($2,000,000) by wire transfer of immediately available funds (the “ADC Access Fee”).
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
6.1.2
Licensee shall pay SGI at a rate of
[*]
per FTE for the performance by such FTEs as requested by Licensee pursuant to Sections 2.4, 5.3.2 and 5.3.3 and Articles 2, 4 and 11 of this Agreement (the “
Personnel Fees
”). Commencing upon the
[*]
of the Effective Date and upon every
[*]
thereafter, the Personnel Fees will increase by
[*]
per FTE per year. The Personnel Fees and the Supply Fees are collectively referred to herein as the “
Research Fees
”. For purposes of clarification, costs for labor that are appropriately includable within the calculation of Personnel Fees shall not be included in the calculation of Supply Fees. Within
[*]
days after the end of each
[*]
, SGI shall submit a report to Licensee supporting the calculation of the Research Fees due for such
[*]
(a “
Research Fees Report
”). Licensee shall pay all Research Fees to SGI within
[*]
of receipt of each Research Fees Report.
6.1.3
SGI shall be obligated to maintain all books and records relating to Research Fees billed to Licensee during the Term. Licensee shall have the right to engage an independent certified public accounting firm of internationally recognized standing, selected by Licensee and reasonably acceptable to SGI, to audit the books and records of SGI related to the Research Fees to verify the accuracy of the Research Fees Reports upon at least
[*]
prior notice and
[*]
. Such accountants may audit the books and records relating to the Research Fees Reports for any year
[*]
of such request. The accounting firm shall disclose to Licensee only whether such Research Fees Reports were correct or not, and the specific details concerning any discrepancies. No other information obtained by such accountants shall be shared with Licensee. If such accounting firm concludes that there was an overpayment of the Research Fees during any time period that is subject to the audit, SGI shall refund such overpayment within
[*]
of the date Licensee delivers to SGI such accounting firm’s written report so correctly concluding. The fees charged by such accounting firm shall be paid by
[*]
;
provided
,
however
, if the audit discloses that the Research Fees charged for the audited period are more than
[*]
of the Research Fees actually due for such period, then
[*]
shall pay the reasonable fees and expenses charged by such accounting firm. If such accounting firm concludes that the Research Fees paid were less than what was owed during such period, Licensee shall pay the amount of any underpayment within
[*]
of the date Licensee receives such accounting firm’s written report so concluding.
6.2
License Maintenance Fees
. Licensee shall be
[*]
to SGI in the sum of
[*]
by wire transfer of immediately available funds (the “
Exclusive License Renewal Fee
”) on
[*]
. Notwithstanding the foregoing, the Exclusive License Renewal Fee
[*]
.
6.3
Royalties Payable by Licensee
. In consideration for the Exclusive License granted to Licensee herein, during the Royalty Term, and subject to Section 6.4, Licensee shall pay to SGI royalties on Net Sales of Licensed Products. Such royalties shall be paid at the following rates, determined on a Licensed Product-by-Licensed Product basis as set forth below:
6.3.1
[*]
of the first
[*]
in aggregate
[*]
of the
[*]
in
[*]
;
6.3.2
[*]
of the portion of aggregate
[*]
of the
[*]
between
[*]
; and
6.3.3
[*]
of the portion of aggregate
[*]
of the
[*]
in excess of
[*]
.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
In establishing the royalty structure of this Section 6.3, the Parties recognize, and Licensee acknowledges, the substantial value of the various actions and investments undertaken by SGI prior to the Effective Date. Such value is significant and in addition to the value of SGI’s grant to Licensee of the Exclusive License pursuant to Section 3.1, as it enables the rapid and effective development and commercialization of the Licensed Products in the Territory. Therefore, the Parties agree that the royalty payments calculated as a percentage of [*] (plus the license fee, milestone payments and other payment provided for elsewhere herein) provide fair compensation to SGI for these additional benefits.
6.4
Royalty Reductions
. During the Royalty Term, the royalties otherwise payable under Section 6.3 shall be
[*]
:
6.4.1
With respect to any country in which royalties are payable in accordance with Section 6.3 above, during any period in which there is
[*]
, the royalty rate otherwise in effect under Section 6.3 shall be
[*]
in such country during such period.
6.4.2
With respect to any country in which royalties are payable in accordance with Section 6.3 above, during any period in which
[*]
, the royalties otherwise payable in accordance with Section 6.3 shall be
[*]
in such country during such period.
6.4.3
Licensee shall be solely responsible for paying all royalties owed to Third Parties by either Licensee or by SGI under SGI In-Licenses on account of sales of Licensed Products, including royalties owed due to use of the SGI Technology;
[*]
. SGI represents and warrants that all Third Party royalties owed pursuant to the SGI In-Licenses existing as of the Effective Date are described in
Schedule B
(“
Existing Third Party Royalties
”).
6.4.4
If the sum of (a) the royalties payable by Licensee, its Affiliates or Sublicensees to SGI under
[*]
(taking into account Sections 6.4.1 and 6.4.2) and (b) the Existing Third Party Royalties payable by Licensee, its Affiliates or Sublicensees pursuant to Section 6.4.3
[*]
, then the royalties otherwise due and payable by Licensee under Section 6.3 shall be
[*]
of any royalties due by Licensee with respect to
[*]
of a
[*]
in such year that
[*]
of such Net Sales;
provided
,
however
, that in no event shall the royalty payments due and payable to SGI pursuant to Section 6.3 with respect to a Licensed Product in any calendar year be
[*]
of the amount that would otherwise be owed to SGI under
[*]
.
6.5
Milestone Payments
. As additional consideration for the licenses, rights and privileges granted to it hereunder, Licensee shall pay to SGI the following milestone payments within
[*]
of the first occurrence of each event set forth below with respect to the first
[*]
, whether such events are achieved by Licensee, its Affiliates or Sublicensees, as follows:
6.5.1
Upon
[*];
6.5.2
Upon
[*]
;
6.5.3
Upon
[*];
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
6.5.4
Upon
[*]
;
6.5.5
Upon
[*]
;
6.5.6
Upon
[*]
; and
6.5.7
Upon
[*]
.
If any of the milestone events set forth in Sections 6.5.1 through 6.5.6 above is achieved before a preceding milestone, then such payment shall be deemed to become due within [*] of the achievement of the subsequent milestone. [*].
6.6
Payment Terms
. Royalties shown to have accrued by each Report provided for under Article 7 of this Agreement shall be due on the date such Report is due pursuant to Section 7.1.3.
6.7
Payment Method
. All payments by Licensee to SGI under this Agreement shall be paid in U.S. dollars, and all such payments shall be made by bank wire transfer in immediately available funds to the bank account designated by SGI in writing.
6.8
Exchange Control
. If at any time legal restrictions prevent the prompt remittance of part or all royalties with respect to any country in the Territory where Licensed Product is sold, payment shall be made through such lawful means or method as the Parties reasonably shall determine.
6.9
Withholding Taxes
. Licensee shall be entitled to deduct the amount of any withholding taxes payable or required to be withheld by Licensee, its Affiliates or Sublicensees, to the extent Licensee, its Affiliates or Sublicensees pay such withheld amounts to the appropriate governmental authority on behalf of SGI. Licensee shall use Commercially Reasonable Efforts to minimize any such taxes, levies or charges required to be withheld on behalf of SGI by Licensee, its Affiliates or Sublicensees. Licensee promptly shall deliver to SGI proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto, and shall cooperate with SGI in seeking any related tax credits that may be available to SGI with respect thereto.
ARTICLE 7
ROYALTY REPORTS AND ACCOUNTING
7.1
Reports, Exchange Rates
.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
7.1.1
During the Royalty Term, Licensee shall furnish to SGI, within
[*]
of the end of each
[*]
, a written report showing, on a consolidated basis in reasonably specific detail and on a country-by-country basis, with respect to such
[*]
, (a) the gross sales of Licensed Products sold by Licensee, its Affiliates and its Sublicensees in the Territory during such
[*]
and the calculation of Net Sales from such gross sales; (b) the royalties payable in U.S. dollars, if any, which shall have accrued hereunder based upon such Net Sales of Licensed Products; (c) the withholding taxes, if any, required by law to be deducted in respect of such royalties; (d) the dates of the First Commercial Sale of each Licensed Product in each country in the Territory, if it has occurred during such
[*]
; and (e) the exchange rates (as determined pursuant to Section 7.1.4 herein) used in determining the royalty amount expressed in U.S. dollars (collectively, “
Reports
”).
7.1.2
Licensee shall include in each permitted sublicense granted by it pursuant to this Agreement a provision requiring its Affiliates and Sublicensees to make Reports to Licensee sufficiently in advance of Licensee’s reporting deadline under Section 7.1.1 so as to enable Licensee to meet such deadlines and to keep and maintain records of sales made pursuant to each sublicense as if such sales were by Licensee for the purpose of Section 7.1.1.
7.1.3
Licensee shall keep complete and accurate records in sufficient detail to properly reflect all gross sales and Net Sales and to enable the royalties payable hereunder to be determined.
7.1.4
With respect to Net Sales invoiced in U.S. dollars, the Net Sales and the amounts due to SGI hereunder shall be expressed in U.S. dollars. With respect to Net Sales invoiced or expenses incurred in a currency other than U.S. dollars, the Net Sales or expenses shall be expressed in the domestic currency of the entity making the sale, together with the U.S. dollar equivalent, calculated using the
[*]
.
7.2
Audits
.
7.2.1
Upon the written request of SGI and with at least
[*]
prior written notice, but not more than
[*]
in any
[*]
, Licensee shall permit an independent certified public accounting firm of internationally recognized standing, selected by SGI and reasonably acceptable to Licensee, at SGI’s expense, to have access during normal business hours to such of the records of Licensee as required to be maintained under this Agreement to verify the accuracy of the Reports due hereunder. Such accountants may audit records relating to Reports made for any year
[*]
. The accounting firm shall disclose to SGI only whether the Reports were correct or not, and the specific details concerning any discrepancies. No other information obtained by such accountants shall be shared with SGI. The accounting firm shall provide a copy of its report to Licensee at the same time that such report is provided to SGI.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
7.2.2
If such accounting firm concludes that any royalties were owed but not paid to SGI, Licensee shall pay the additional royalties within
[*]
after the date of such determination. The fees charged by such accounting firm shall be paid by
[*]
;
provided
,
however
, if the audit discloses that the royalties payable by Licensee for the audited period are more than
[*]
of the royalties actually paid for such period, then
[*]
shall pay the reasonable fees and expenses charged by such accounting firm. If such accounting firm concludes that the royalties paid were more than what was owed during such period, SGI shall refund the overpayments within
[*]
of the date SGI receives such accounting firm’s written report so concluding.
7.3
Confidential Financial Information
.
SGI shall treat all financial information subject to review under this Article 7 or under any sublicense agreement as Confidential Information of Licensee as set forth in Article 8, and shall cause its accounting firm to retain all such financial information in confidence under terms substantially similar to those set forth in Article 8.
ARTICLE 8
CONFIDENTIALITY
8.1
Non-Disclosure Obligations
. Except as otherwise provided in this Article 8, during the Term and for a period of
[*]
thereafter, each Party shall maintain in confidence, and use only for purposes as expressly authorized and contemplated by, or in the exercise of its rights and performance of its obligations under, this Agreement, all Confidential Information, of the other Party. “
Confidential Information
” means all confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer or other form, provided by one Party (the “
Disclosing Party
”) to the other Party (the “
Receiving Party
”) pursuant to this Agreement or generated pursuant to this Agreement or the Research Collaboration Agreement, including but not limited to, information relating to the Disclosing Party’s existing or proposed research, development efforts, patent applications, business or products and any other materials that have not been made available by the Disclosing Party to the general public. Confidential Information of SGI shall include SGI Know-How, Drug Conjugation Materials and SGI’s interest in any Inventions and New Technologies. Confidential Information of Licensee shall include Licensee Know-How, Licensee ADC Know-How and Licensee’s interests in all Inventions. Each Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that its and its Affiliates’ employees, agents, consultants and clinical investigators only make use of the other Party’s Confidential Information for purposes as expressly authorized and contemplated by this Agreement and do not disclose or make any unauthorized use of such Confidential Information.
8.2
Permitted Disclosures
. Notwithstanding the foregoing, but subject to the last sentence of this Section 8.2, information, documents and materials will not be considered as “Confidential Information” and the provisions of Section 8.1 shall not apply to information, documents or materials that the Receiving Party can conclusively establish:
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
8.2.1
have become published or otherwise entered the public domain other than by breach of this Agreement by the Receiving Party or its Affiliates;
8.2.2
have become known to the Receiving Party by disclosure from a Third Party, provided such Confidential Information was not obtained by such Third Party directly or indirectly from the Disclosing Party on a confidential basis;
8.2.3
prior to disclosure under the Agreement, was already in the possession of the Receiving Party, its Affiliates or Sublicensees, provided such Confidential Information was not obtained directly or indirectly from the Disclosing Party;
8.2.4
are required to be disclosed by the Receiving Party to comply with any applicable law, regulation or court order, provided that the Receiving Party shall provide prior notice of such disclosure to the Disclosing Party and take reasonable and lawful actions to avoid or minimize the degree of disclosure; and
8.2.5
is independently developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Confidential Information.
8.3
Terms of the Agreement
. Except as otherwise provided in this Article 8, Licensee and SGI shall not disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party, except as required by applicable laws, regulations or a court order or to comply with rules of a securities exchange, in which case the disclosing Party shall provide notice to the other Party and take reasonable and lawful actions to avoid or minimize the degree of such disclosures.
8.4
Press Releases and Other Disclosures to Third Parties
. Except as otherwise provided in this Article 8, neither SGI nor Licensee will, without the prior written consent of the other which consent will not be unreasonably withheld, conditioned or delayed, issue any press release or make any other public announcement or furnish any statement to any person or entity (other than either Parties’ respective Affiliates) concerning the existence of this Agreement, its terms and the transactions contemplated hereby, except for (i) an initial press release mutually agreed upon by the Parties, (ii) disclosures made in compliance with Sections 8.2, 8.3 and 8.5, (iii) disclosures made to attorneys, consultants, accountants and other service providers retained by SGI or Licensee; provided, that such service providers are under obligations of confidentiality at least as restrictive as those contained herein. Notwithstanding anything contained in this Article 8 to the contrary, Licensee and its Affiliates shall be entitled to disclose the terms of this Agreement and information and results arising hereunder (including clinical trial results) to governmental agencies, including but not limited to the Securities and Exchange Commission and the FDA, if in the reasonable opinion of their respective counsel such disclosure is necessary to comply with law; provided, however, that such disclosure shall be sent to SGI for review no later than
[*]
prior to sending to such governmental agencies and Licensee and its Affiliates shall redact those portions of such disclosure as reasonably requested by SGI in accordance with applicable laws or regulations in order to protect SGI’s Confidential Information to the extent that such redaction would not, in the good faith belief of Licensee or its Affiliates, as applicable, result in violation of applicable law.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
8.5
Publications Regarding Results of the Research Program
. Neither Party may publish, present or announce results of the Research Program either orally or in writing (a “
Publication
”) without complying with the provisions of this Section 8.5. The other Party shall have
[*]
from receipt of a proposed Publication to provide comments and/or proposed changes to the publishing Party. The publishing Party shall reasonably take into account the comments and/or proposed changes made by the other Party on any Publication and shall agree to designate employees or others acting on behalf of the other Party as co-authors on any Publication describing results to which such persons have contributed in accordance with standards applicable to authorship of scientific publications. If the other Party reasonably determines that the Publication would entail the public disclosure of such Party’s Confidential Information and/or of a patentable invention upon which a patent application should be filed prior to any such disclosure, submission of the concerned Publication to Third Parties shall be delayed for
[*]
any such Confidential Information of the other Party (if the other Party has requested deletion thereof from the proposed Publication), and/or the drafting and filing of a patent application covering such invention, provided such additional period shall not exceed
[*]
from the date the publishing Party first provided the proposed Publication to the other Party; provided, however, that such
[*]
period shall be extended for an additional reasonable period of time if the non-publishing Party is diligently pursuing appropriate means to protect its intellectual property.
ARTICLE 9
INVENTIONS AND PATENTS
9.1
Ownership of Inventions
.
9.1.1
Disclosure of Inventions
. Each Party shall promptly disclose to the other Party Inventions made by such Party during the Term.
9.1.2
Ownership of Inventions
. All right, title and interest in all Inventions shall be owned as follows:
(a)
Licensee shall own and have the sole right in accordance with Section 9.2.2 to file patent applications on all Inventions that (i) are made solely by one or more employees, agents or consultants of
[*]
or (ii) are made solely by
[*]
(“
Licensee Inventions
”). To the extent that any Licensee Inventions shall have been made solely by
[*]
. For the avoidance of doubt, Licensee shall
[*]
, including without limitation patents or patent applications claiming compositions of matter or methods of use of Licensed Products.
(b)
SGI shall own and shall have the sole right in accordance with Section 9.2.2 to file patent applications on all Inventions that (i) are made solely by one or more employees, agents or consultants of
[*]
or (ii) are made solely by
[*]
(“
SGI Inventions
”). To the extent that any SGI Inventions shall have been made solely by
[*]
.
(c)
Except as set forth in Sections 9.1.2 (a) and 9.1.2 (b), Licensee and SGI shall jointly own all other Inventions (“
Joint Inventions
”).
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
(d)
Inventorship, for the purposes of this Agreement, shall be determined in accordance with U.S. patent law.
9.2
Patent Prosecution and Maintenance
.
9.2.1
SGI shall be responsible for and shall control the preparation, filing, prosecution, grant and maintenance of all SGI Patents. SGI shall, at its sole expense, prepare, file, prosecute and maintain such SGI Patents in good faith consistent with its customary patent policy and its reasonable business judgment, and shall consider in good faith the interests of Licensee in so doing. SGI shall promptly provide Licensee a copy of all material, publicly available filings related to the SGI Patents to the extent such SGI Patents are related to a Licensed Product.
9.2.2
Each Party shall be responsible for and shall control the preparation, filing, prosecution, grant and maintenance, of any patents and patent applications claiming Inventions owned
[*]
by it in accordance with
[*]
and shall,
[*]
in good faith consistent with
[*]
. Patents and patent applications claiming Inventions owned
[*]
shall be controlled, prepared, filed, prosecuted and maintained by
[*]
. The Party responsible for filing and controlling patent prosecution and maintenance for Inventions shall provide to the other Party copies of any response, document or communication with patent authorities that could materially affect the scope of any patent or patent application covering Inventions or detrimentally effect the rights of the Parties in such inventions in any way, at least
[*]
prior to the planned submission or communication. Such other Party shall have the opportunity to comment on the response or document within such
[*]
period, which comments shall be reasonably considered by the Party primarily responsible for the prosecution.
9.2.3
If either Party decides not to continue prosecuting patent applications or not to maintain a patent claiming an Invention assigned to such Party pursuant to Section 9.1 in whole or in part, then such Party shall promptly so notify the other Party (which notice shall be at least
[*]
before any relevant deadline for such patent application or patent). Thereafter, the other Party shall have the right to prosecute or maintain such patent application or patent, at such Party’s sole expense. The Party responsible for filing and controlling patent prosecution and maintenance for Inventions shall provide to the other Party copies of any response, document or communication with patent authorities that could materially affect the scope of any patent or patent application covering Inventions or detrimentally effect the rights of the Parties in such Inventions in any way, at least
[*]
prior to the planned submission or communication. Such other Party shall have the opportunity to comment on the response or document within such
[*]
period, which comments shall be reasonably considered by the Party primarily responsible for the prosecution.
9.2.4
The Parties shall at all times fully cooperate in order to reasonably implement the foregoing provisions, such cooperation may include the execution of necessary legal documents, coordinating prosecution to avoid issues during prosecution including enablement, estoppel and double patenting, and the provision of the assistance of its relevant personnel. Further, notwithstanding anything to the contrary herein, neither Party shall disclose in any patent application, patent or publication of such party the Confidential Information of the other Party without prior written consent.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
9.3
Enforcement of SGI Patents
.
9.3.1
SGI shall have the first right,
[*]
, but not the obligation, to determine the appropriate course of action to enforce the
[*]
or otherwise abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce the
[*]
, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to the
[*]
; provided, that SGI shall not settle any such action in a manner that would materially negatively affect the rights or obligations of Licensee hereunder without Licensee’s prior consent, which consent shall not be unreasonably withheld. SGI shall in good faith consider the interests of Licensee in conducting the foregoing activities. All monies recovered upon the final judgment or settlement of any such suit to enforce any
[*]
with respect to the manufacture, use or sale by Third Parties of products competitive with Licensed Products or technologies competitive with technologies related to the manufacture or use of Drug Conjugation Materials or ADCs shall be
[*]
. In the event Third Parties have rights in the SGI Patents under other license agreements between SGI and such Third Parties, such recoveries shall be
[*]
. Licensee shall reasonably cooperate with SGI in any such action at SGI’s expense, to enforce the SGI Patents, including being joined as a party to such action if necessary.
9.3.2
If
[*]
fails to take any action to enforce the
[*]
or control any litigation with respect to the
[*]
with respect to the manufacture, use or sale by Third Parties of products competitive with Licensed Products or technologies competitive with technologies related to the manufacture or use of Drug Conjugation Materials or ADCs within a period of ninety (90) days after the Parties receive reasonable notice of the infringement of the
[*]
, then
[*]
. In such case, all monies recovered upon the final judgment or settlement of any such suit to enforce any
[*]
shall be retained by
[*]
. In the event Third Parties have rights in the SGI Patents under other license agreements between SGI and such Third Parties, such recoveries shall be
[*]
. In such a case, SGI shall reasonably cooperate with Licensee,
[*]
, in its efforts to enforce the
[*]
, including being joined as a party to such action if necessary. In no event may Licensee assert an argument or settle a suit in a manner which would render a claim in the
[*]
invalid or unenforceable without SGI’s prior written consent.
9.3.3
[*]
shall have the right, at its sole expense, to determine the appropriate course of action to enforce patents claiming
[*]
, or otherwise to abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce the
[*]
, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to the
[*]
. All monies recovered upon the final judgment or settlement of any such suit to enforce any
[*]
. SGI shall reasonably cooperate with Licensee, at Licensee’s expense, in any action to enforce the
[*]
.
9.3.4
In the event either Party becomes aware of an infringement by a Third Party of a Joint Patent, it shall promptly notify the other Party and the Parties shall determine a mutually agreeable course of action; provided, however, that if such infringement relates to a
[*]
, or otherwise to abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce the Joint Patents, to control any litigation or other enforcement action and to enter into or permit the settlement of any such litigation or enforcement action with respect to such Joint Patent; provided, however, that in no event shall any Party make an argument or settle a dispute which would render a claim in a Joint Patent to be invalid or unenforceable or that would materially negatively affect the rights of the other Party with respect to such Joint Patent without the other Party’s prior written consent. All monies recovered upon the final judgment or settlement of any such suit to enforce any Joint Patent shall be
[*]
.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
9.4
Prior Patent Rights
. Notwithstanding anything to the contrary in this Agreement, with respect to any SGI Patents that are subject to the SGI In-Licenses, the rights and obligations of the Parties under Section 9.2 and 9.3 shall be subject to SGI’s licensors’ rights to participate in and control prosecution, maintenance and enforcement of such SGI Patents, and to receive a share of damages recovered in such action, in accordance with the terms and conditions of the applicable SGI In-License.
ARTICLE 10
INFRINGEMENT ACTIONS BROUGHT BY THIRD PARTIES
If Licensee, SGI or any of their respective Affiliates or Sublicensees, is sued by a Third Party for infringement of a Third Party’s patent because of the research, development, manufacture, use or sale of Licensed Products, the Party that has been sued shall promptly notify the other Party in writing within ten (10) days of its receipt of written notice of such suit. The notice shall set forth the material facts to the extent available to the relevant Party, including the nature of the claims made and the patents with respect to which infringement is claimed. Licensee shall have the first right, but not the obligation, to defend against such suit at its sole cost and expense, with counsel chosen by Licensee; provided, that if such suit relates primarily to the [*] specifically, then [*]
shall have the first right, but not the obligation, to defend against such suit at its sole cost and expense. Each Party agrees to be joined as a party if necessary to defend the action or proceeding and shall provide all reasonable cooperation, including any necessary use of its name, required to defend against such suit. The Party controlling the defense of such suit shall have sole control of any such suit and all negotiations for its settlement or compromise, provided that such Party shall not settle or compromise any such suit or enter into any consent order for the settlement or compromise thereof without the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned. If, prior to the expiration of [*] from such claim being brought, or such sooner period as may be necessary to appropriately respond to said claim, the responsible Party has not elected to defend such action or proceeding, or if the responsible Party shall notify the other Party at any time prior thereto of its intention not to defend such action or proceeding, then, and in those events only, the other Party shall have the right, but not be obligated, to defend and control any action or proceeding. Each Party agrees to be joined as a party if necessary to defend the action or proceeding and shall provide all reasonable cooperation, including any necessary use of its name, required to defend against such suit.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
ARTICLE 11
REGULATORY ASSISTANCE
All Regulatory Approvals with respect to Licensed Products in the Field in the Territory shall be in the name of Licensee or its Sublicensee. Licensee shall have exclusive control and authority over, and responsibility for, the regulatory strategies relating to the development and commercialization of all Licensed Products in the Field in the Territory, including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval of Licensed Products in the Field in the Territory (including each IND); and (b) all regulatory actions, communications and meetings with any governmental authority with respect to any Licensed Product in the Field in the Territory. Upon the request of Licensee, SGI shall use Commercially Reasonable Efforts to provide to Licensee on a timely basis such information as may be required or useful for the foregoing regulatory activities, and otherwise provide reasonable assistance to Licensee in complying with all regulatory obligations, including certifications and product approvals. Licensee shall be responsible for interfacing, corresponding and meeting with all Regulatory Authorities with respect to any Licensed Product in the Field in the Territory. Except as required by applicable law or in response to a request of Licensee, SGI shall not communicate directly with the FDA or any other governmental authority relating to any Licensed Product without the prior written consent of Licensee. In furtherance thereof, SGI shall refer all FDA communications relating to any Licensed Product to Licensee. SGI shall cooperate with Licensee to provide all reasonable assistance and take all actions reasonably requested by Licensee that are necessary to comply with any law in the Territory applicable to any Licensed Product in the Field. SGI hereby [*] required to support the filing of all submissions relating to Regulatory Approval of a Licensed Product in the Field in the Territory, solely for purposes of allowing Licensee to obtain and maintain submissions relating to Regulatory Approvals for Licensed Products in the Field in the Territory. In furtherance of the foregoing, SGI shall, promptly upon request of Licensee, deliver a letter to the FDA, in form and substance reasonably acceptable to Licensee, authorizing Licensee to reference the drug master files of SGI. SGI will inform Licensee of all changes to drug master files that will or might be reasonably likely to affect the regulatory filings of Licensee. Licensee shall reimburse SGI for any out of pocket costs incurred by SGI in providing any such information plus an amount equal to SGI’s then current Personnel Fee for SGI’s personnel engaged in such activities, as set forth in Section 6.1.2.
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1
Representations and Warranties
.
12.1.1
This Agreement has been duly executed and delivered by each Party and constitutes the valid and binding obligation of each Party, enforceable against such Party in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium or other laws relating to or affecting creditors’ rights generally and by general equitable principals. The execution, delivery and performance of this Agreement has been duly authorized by all necessary action on the part of each Party.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
12.1.2
The execution, delivery and performance of the Agreement by each Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.
12.1.3
SGI represents and warrants that it has the right to grant the licenses and sublicenses granted herein and that as of the Effective Date it has
[*]
in connection with activities to be conducted hereunder. Licensee represents and warrants that it has the right to grant the licenses granted to SGI herein and that as of the Effective Date it has
[*]
.
12.1.4
Licensee and SGI shall comply in all material respects with all applicable laws, rules and regulations in the development and commercialization of Licensed Products and each shall cause its Affiliates and Sublicensees to do the same.
12.2
Additional SGI Representations, Warranties and Covenants
. SGI represents, warrants and covenants to Licensee that:
12.2.1
all Third Party royalties owed pursuant to the existing SGI In-Licenses are listed in
Schedule B
.
12.2.2
all patents and patent applications included within the SGI Patents listed on
Schedule B
are existing and,
[*]
;
12.2.3
all inventors of any inventions included within the SGI Patents listed on
Schedule B
have
[*]
and (ii) to
[*]
;
12.2.4
each of the SGI In-Licenses are in
[*]
of each of the parties thereto and are in the form previously furnished to Licensee;
12.2.5
SGI (i) has the right to grant the licenses granted herein; (ii) Controls the patents and patent applications listed on Schedule B and (iii) that as of the Effective Date it has
[*]
;
12.2.6
the
[*]
;
12.2.7
the
[*]
;
12.2.8
neither
[*]
;
12.2.9
there are no claims, judgments or settlements against SGI pending or,
[*]
;
12.2.10
it has obtained the
[*]
; and
12.2.11
[*]
.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
12.3
Performance by Affiliates
. The Parties recognize that each may perform some or all of its obligations under this Agreement through Affiliates, provided, however, that each Party shall remain responsible and be a guarantor of the performance by its Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.
ARTICLE 13
TERM AND TERMINATION
13.1
Term
. Unless earlier terminated pursuant to this Article 13, the term of this Agreement (the “
Term
”) shall commence on the Effective Date and shall remain in full force and effect until the expiration of the last to expire Royalty Term.
13.2
Termination by Licensee
. Licensee shall have the right to terminate this Agreement in its entirety by providing not less than
[*]
prior written notice to SGI of such termination.
13.3
Termination for Cause
. Either Party may terminate this Agreement for material breach by the other Party (the “
Breaching Party
”) of any material provision of the Agreement, if the Breaching Party has not cured such breach within
[*]
after notice thereof. In addition, all rights and obligations under an SGI In-License sublicensed under this Agreement shall terminate upon
[*]
prior written notice by SGI if Licensee performs any action that would constitute a breach of any material provision of such SGI In-License Agreement
[*]
and fails to cure such breach within such
[*]
period; provided, however, such cure period may be extended by mutual written consent of the Parties. All rights and obligations under the
[*]
.
13.4
Termination Upon Insolvency
. Either Party may terminate this Agreement if, at any time, (a) the other Party shall file in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, (b) such other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within
[*]
after the filing thereof, (c) such other Party shall propose or be a party to any dissolution or liquidation, or (d) such other Party shall make an assignment for the benefit of its creditors.
13.5
Effect of Expiration and Termination
.
13.5.1
Except where explicitly provided within this Agreement, termination of this Agreement for any reason, or expiration of this Agreement, will not affect any: (a) obligations, including payment of any royalties or other sums which have accrued as of the date of termination or expiration, and (b) rights and obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement, including provisions of Articles 1, 8, 9, 10, 13, 14, 18 and 19, Sections 6.1.2, 7.2 and 7.3 and any payment obligations pursuant to Section 6 incurred prior to termination.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
13.5.2
Subject to Section 13.5.3, all licenses granted by SGI to Licensee hereunder, including the Exclusive License, and all sublicenses granted by Licensee hereunder, will immediately terminate upon termination of this Agreement pursuant to Sections 13.2, 13.3 (if SGI is terminating party) or 13.4 (if SGI is terminating party).
13.5.3
Upon termination of this Agreement for any reason, any Sublicensee hereunder who has not breached its sublicense in any material respect shall be entitled to receive a license directly from SGI granting rights substantially the same in all material respects as those granted in such sublicense and containing obligations as a licensee identical to those set forth in this Agreement; provided, however, that (a) each such Sublicensee shall expressly agree in writing to be bound by the terms and conditions of such direct license, and (b) the obligations of SGI under any such direct license shall be no greater than the obligations of SGI hereunder.
13.5.4
Upon the expiration of the Royalty Term, SGI shall grant, and shall by this provision be deemed to have granted, to Licensee a royalty-free, perpetual, worldwide, nonexclusive license to use the SGI Technology to make, have made, import, have imported and use Drug Conjugation Materials and Licensed Products, for the offer for sale and sale of Licensed Products, with no further obligation to SGI.
13.5.5
Upon any termination of the Exclusive License, except by Licensee in accordance with
[*]
, Licensee shall be automatically deemed to grant to
[*]
.
13.6
[*]
Notwithstanding the foregoing, such election shall not preclude the exercise by Licensee of any other remedies available to it under the terms of this Agreement, in law or in equity.
ARTICLE 14
INDEMNITY
14.1
Licensee
. Licensee shall defend SGI and its Affiliates at Licensee’s cost and expense, and will indemnify and hold SGI and its Affiliates and their respective directors, officers, employees and agents (the “
SGI Indemnified Parties
”) harmless from and against any and all losses, costs, damages, fees or expenses (including reasonable attorney’s fees and expenses) (“
Losses
”) incurred in connection with or arising out of any Third Party claim (a “
Third Party Claim
”) relating to (i) any material breach by Licensee of this Agreement, (ii) any gross negligence or willful misconduct of Licensee in the exercise of any of its rights or the performance of any of its obligations under this Agreement, or (iii) any liability or other claims arising from the manufacture, handling, packaging, storage, sale or other disposition of any Licensed Product by Licensee or any of its Affiliates or Sublicensees; provided, however, that the obligations set forth in this Section 14.1 shall not apply to the extent that such Losses were incurred in connection with, or have arisen out of, any act or omission of gross negligence or willful misconduct on the part of SGI for which SGI would otherwise be required to indemnify the Licensee Indemnified Parties pursuant to Section 14.2.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
14.2
SGI
. SGI shall defend Licensee and its Affiliates at SGI’s cost and expense, and will indemnify and hold Licensee and its Affiliates and their respective directors, officers, employees and agents (the “
Licensee Indemnified Parties
”) harmless from and against any and all Losses incurred in connection with or arising out of any Third Party Claim relating to (i) any material breach by SGI of this Agreement, (ii) any gross negligence or willful misconduct of SGI in the exercise of any of its rights or the performance of any of its obligations under this Agreement, (iii) any product liability, clinical trial liability or other claims arising from the manufacture, handling, packaging, storage, sale or other disposition of any Drug Conjugation Materials or ADCs by SGI or its Affiliates, or (iv) an SGI In-License Agreement for which SGI would be entitled to indemnification thereunder; provided, however, that the obligations set forth in this Section 14.2 shall not apply to the extent that such Losses were incurred in connection with, or have arisen out of, any act or omission of gross negligence or willful misconduct on the part of Licensee for which Licensee would otherwise be required to indemnify the SGI Indemnified Parties pursuant to Section 14.1.
14.3
Indemnification Procedures
.
14.3.1
In the case of a Third Party Claim made by any Person who is not a Party to this Agreement (or an Affiliate thereof) as to which a Party (the “
Indemnitor
”) may be obligated to provide indemnification pursuant to this Agreement, such Party seeking indemnification hereunder (“
Indemnitee
”) will notify the Indemnitor in writing of the Third Party Claim (and specifying in reasonable detail the factual basis for the Third Party Claim and to the extent known, the amount of the Third Party Claim) reasonably promptly after becoming aware of such Third Party Claim; provided, however, that failure to give such notification will not affect the indemnification provided for hereunder except to the extent the Indemnitor shall have been actually prejudiced as a result of such failure.
14.3.2
If a Third Party Claim is made against an Indemnitee and the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee therefor, the Indemnitor will be entitled, within one hundred twenty (120) days after receipt of written notice from the Indemnitee of the commencement or assertion of any such Third Party Claim, to assume the defense thereof (at the expense of the Indemnitor) with counsel selected by the Indemnitor and reasonably satisfactory to the Indemnitee, for so long as the Indemnitor is conducting a good faith and diligent defense. Should the Indemnitor so elect to assume the defense of a Third Party Claim, the Indemnitor will not be liable to the Indemnitee for any legal or other expenses subsequently incurred by the Indemnitee in connection with the defense thereof; provided, that if under applicable standards of professional conduct a conflict of interest exists between the Indemnitor and the Indemnitee in respect of such claim, such Indemnitee shall have the right to employ separate counsel (which shall be reasonably satisfactory to the Indemnitor) to represent such Indemnitee with respect to the matters as to which a conflict of interest exists and in that event the reasonable fees and expenses of such separate counsel shall be paid by such Indemnitor; provided, further, that the Indemnitor shall only be responsible for the reasonable fees and expenses of one separate counsel for such Indemnitee. If the Indemnitor assumes the defense of any Third Party Claim, the Indemnitee shall have the right to participate in the defense thereof and to employ counsel, at its own expense, separate from the counsel employed by the Indemnitor.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
If the Indemnitor assumes the defense of any Third Party Claim, the Indemnitor will promptly supply to the Indemnitee copies of all correspondence and documents relating to or in connection with such Third Party Claim and keep the Indemnitee informed of developments relating to or in connection with such Third Party Claim, as may be reasonably requested by the Indemnitee (including, without limitation, providing to the Indemnitee on reasonable request updates and summaries as to the status thereof). If the Indemnitor chooses to defend a Third Party Claim, all Indemnitees shall reasonably cooperate with the Indemnitor in the defense thereof (such cooperation to be at the expense, including reasonable legal fees and expenses, of the Indemnitor). If the Indemnitor does not elect to assume control of the defense of any Third Party Claim within the one hundred twenty (120) day period set forth above, or if such good faith and diligent defense is not being or ceases to be conducted by the Indemnitor, the Indemnitee shall have the right, at the expense of the Indemnitor, after three (3) Business Days notice to the Indemnitor of its intent to do so, to undertake the defense of the Third Party Claim for the account of the Indemnitor (with counsel selected by the Indemnitee), and to compromise or settle such Third Party Claim, exercising reasonable business judgment and with the written consent of the non-electing Indemnitor, which consent shall not be unreasonably withheld.
14.3.3
If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee will agree to any settlement, compromise or discharge of such Third Party Claim that the Indemnitor may recommend that by its terms obligates the Indemnitor to pay the full amount of Losses (whether through settlement or otherwise) in connection with such Third Party Claim and unconditionally and irrevocably releases the Indemnitee completely from all liability in connection with such Third Party Claim; provided, however, that, without the Indemnitee’s prior written consent, the Indemnitor shall not consent to any settlement, compromise or discharge (including the consent to entry of any judgment), and the Indemnitee may refuse in good faith to agree to any such settlement, compromise or discharge, that provides for injunctive or other nonmonetary relief affecting the Indemnitee or that otherwise negatively effects the Indemnitee. If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a Third Party Claim, the Indemnitee shall not (unless required by law) admit any liability with respect to, or settle, compromise or discharge, such Third Party Claim without the Indemnitor’s prior written consent (which consent shall not be unreasonably withheld).
14.4
Insurance Proceeds
. Any indemnification hereunder shall be made
[*]
; provided, however, that if, following the payment to the Indemnitee of any amount under this Article 14, such Indemnitee
[*]
.
ARTICLE 15
FORCE MAJEURE
No Party (or any of its Affiliates) shall be held liable or responsible to the other Party (or any of its Affiliates), or be deemed to have defaulted under or breached the Agreement, for failure or delay by such Party in fulfilling or performing any term of the Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party (or any of its Affiliates), including fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, acts of God or acts, earthquakes, or omissions or delays in acting by any governmental authority (collectively, “
Events of Force Majeure
”);
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
provided
,
however
, that the affected Party shall exert all reasonable efforts to eliminate, cure or overcome any such Event of Force Majeure and to resume performance of its covenants promptly. Notwithstanding the foregoing, to the extent that an Event of Force Majeure continues for a period in excess of [*], the affected Party shall promptly notify in writing the other Party of such Event of Force Majeure and within [*] of the other Party’s receipt of such notice, the Parties shall negotiate in good faith either (a) a resolution of the Event of Force Majeure, if possible, (b) an extension by mutual agreement of the time period to resolve, eliminate, cure or overcome such Event of Force Majeure, (c) an amendment of this Agreement to the extent reasonably possible, or (d) an early termination of this Agreement. All payments accruing prior to, or during, the Events of Force Majeure shall be made in accordance with the terms of this Agreement; however, the foregoing notwithstanding, no Exclusive License Renewal Fee shall be paid during any period where the provisions of this Article 15 have been invoked by SGI and continue in force.
ARTICLE 16
ASSIGNMENT
This Agreement may not be assigned or otherwise transferred, nor, except as expressly provided hereunder, may any right or obligation hereunder be assigned or transferred to any Third Party by either Party without the consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed;
provided
,
however
, that either Party may, without such consent but with notification, assign this Agreement and its rights and obligations hereunder to any of its Affiliates or in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger or consolidation of such Party. Any permitted assignee shall assume all rights and obligations of its assignor under this Agreement; provided, however, that [*]. Any attempted assignment of this Agreement not in accordance with this Article 16 shall be void and of no effect.
ARTICLE 17
SEVERABILITY
Each Party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent, valid provisions for such invalid provisions, in their economic effect, are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement based on such valid provisions. In case such alternative provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid provisions.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
ARTICLE 18
INSURANCE
During the Term and thereafter for the period of time required below, each Party shall maintain an ongoing basis comprehensive general liability insurance in the minimum amount of [*] for bodily injury and property damage liability; and commencing not later than [*], Licensee shall obtain and maintain on an ongoing basis products liability insurance (including contractual liability coverage on Licensee’s indemnification obligations under this Agreement) in the amount of at least [*] for bodily injury and property damage liability; provided, however, to the extent that Licensee has not [*], Licensee shall maintain product liability insurance in the amount of [*]. All of such insurance coverage shall be maintained with an insurance company or companies having an A.M. Best rating of “A-” or better and an aggregate deductible not to exceed [*]. Not later than the Effective Date, and not later than [*] prior to the first use in humans of the first Licensed Product, Licensee shall provide to SGI a certificate(s) evidencing all required coverage hereunder. Thereafter, Licensee shall maintain such insurance coverage without interruption during the Term and for a period of at least [*] thereafter, and shall provide certificates evidencing such insurance coverage without interruption on an annual basis during the period of time for which such coverage must be maintained. Licensee’s insurance shall name SGI and (to the extent that Licensee has [*] as additional insureds on the products liability insurance required hereunder and shall state that SGI shall be provided at least [*] prior written notice of any cancellation or material change in the insurance policy.
ARTICLE 19
MISCELLANEOUS
19.1
Notices
. Any consent, notice or report required or permitted to be given or made under this Agreement by one of the Parties hereto to the other shall be in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery, first class air mail or courier), first class air mail or courier, postage prepaid (where applicable), addressed to such other Party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the address or in accordance with this Section 19.1 and (except as otherwise provided in this Agreement) shall be effective upon receipt by the addressee.
If to SGI
:
Seattle Genetics, Inc.
21823 30th Drive S.E.
Bothell, WA 98021
Attention: General Counsel
Telephone: (425) 527-4000
Facsimile: (425) 527-4109
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
If to Licensee
:
PSMA Development Company LLC
777 Old Saw Mill River Road
Tarrytown, NY 10591
Attention: President
Telephone: (914) 789-2800
Facsimile: (914) 789-2817
With a copy to
:
Cytogen Corporation
650 College Road East
Suite 650
Princeton, NJ 09540
Attention: General Counsel
Telephone: (609) 750-8200
Facsimile: (609) 452-2476
and
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
Attention: General Counsel
Telephone: (914) 789-2800
Facsimile: (914) 789-2817
19.2
Applicable Law
.
The Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to the conflict of law principles thereof that may dictate application of the laws of any other state.
19.3
Dispute Resolution
.
The Parties agree that if any dispute or disagreement arises between Licensee on the one hand and SGI on the other in respect of this Agreement, they shall follow the following procedure in an attempt to resolve the dispute or disagreement.
19.3.1
The Party claiming that such a dispute exists shall give notice in writing (“
Notice of Dispute
”) to the other Party of the nature of the dispute;
19.3.2
Within
[*]
of receipt of a Notice of Dispute, a nominee or nominees of Licensee and a nominee or nominees of SGI shall meet in person and exchange written summaries reflecting, in reasonable detail, the nature and extent of the dispute, and at this meeting they shall use their reasonable endeavors to resolve the dispute;
19.3.3
If, within a further period of
[*]
, the dispute has not been resolved, the President of SGI and the President of Licensee, or their designees, shall meet at a mutually agreed upon time and location for the purpose of resolving such dispute;
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
19.3.4
If, within a further period of
[*]
, the dispute has not been resolved or if, for any reason, the required meeting has not been held, then the same shall be submitted by the Parties for resolution by an arbitral body in Wilmington, Delaware in accordance with the then-current commercial arbitration rules of the American Arbitration Association (“
AAA
”) except as otherwise provided herein. The Parties shall choose, by mutual agreement,
[*]
of receipt of notice of the intent to arbitrate. If no
[*]
is appointed within the times herein provided or any extension of time that is mutually agreed upon, the AAA shall make such appointment within
[*]
of such failure. The judgment rendered by the
[*]
shall include costs of arbitration, reasonable attorneys’ fees and reasonable costs for expert and other witnesses. Nothing in this Agreement shall be deemed as preventing either Party from seeking injunctive relief (or any other equitable or provisional remedy). If the issues in dispute involve scientific, technical or commercial matters, any arbitrator chosen hereunder shall have educational training and/or industry experience sufficient to demonstrate a reasonable level of relevant scientific, medical and industry knowledge.
19.3.5
In the event of a dispute regarding any payments owing under this Agreement, all undisputed amounts shall be paid promptly when due and the balance, if any, promptly after resolution of the dispute.
19.3.6
Notwithstanding the foregoing, any disputes relating to inventorship or the validity, enforceability or scope of any patent or trademark rights shall be submitted for resolution by a court of competent jurisdiction.
19.4
Entire Agreement
. This Agreement contains the entire understanding of the Parties with respect to the specific subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made are expressly superseded by this Agreement, including, without limitation, the terms of the Research Collaboration Agreement. In the event of conflict of terms included herein with terms of the Research Collaboration Agreement, the terms of this Agreement will dominate. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by both Parties hereto.
19.5
Independent Contractors
. SGI and Licensee each acknowledge that they shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture, agency or any type of fiduciary relationship. Neither SGI nor Licensee 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 Party, without the prior consent of the other Party to do so.
19.6
Affiliates
. Each Party shall cause its respective Affiliates to comply fully with the provisions of this Agreement to the extent such provisions specifically relate to, or are intended to specifically relate to, such Affiliates, as though such Affiliates were expressly named as joint obligors hereunder.
19.7
Waiver
. The waiver by either Party hereto of any right hereunder or the failure to perform or of a breach by the other Party shall 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.
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19.8
Counterparts
. This Agreement may be executed in two counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
19.9
Headings
. Headings in this Agreement are included herein for ease of reference only and shall have no legal effect.
[*] CONFIDENTIAL TREATMENT REQUESTED
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
SEATTLE GENETICS, INC.
By:______________________________
Name:____________________________
Title:_____________________________
PSMA DEVELOPMENT COMPANY LLC
By:______________________________
Name:____________________________
Title:_____________________________
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SCHEDULE A
RESEARCH PLAN
Assistance will be provided in the form of technical summaries and teleconferences as needed. Requested data, reports, methods and materials will be provided on an as available basis and as information is updated. On-site meetings and technical transfer will be provided as needed to advance development efforts. SGI will provide a primary point of contact for development support.
ARTICLE 1
-
RESEARCH SUPPORT
SGI will provide the following research support:
[*]
ARTICLE 2
- PRECLINICAL DEVELOPMENT SUPPORT
SGI will provide the following preclinical support:
[*]
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SCHEDULE B
SGI PATENTS*
Existing SGI Technology
[*]
[*] CONFIDENTIAL TREATMENT REQUESTED
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SCHEDULE C
SGI IN-LICENSES
[*]
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Exhibit 10.35
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (this “
Agreement
”), effective as of February 21, 2001 (the “
Effective Date
”), is entered into between ABGENIX, INC., a Delaware corporation (“
ABX
”), having a place of business at 7601 Dumbarton Circle, Fremont, California 94555, and PSMA DEVELOPMENT COMPANY, LLC, a Delaware limited liability company (“
PSMA
”), having a place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591, with respect to the following facts:
RECITALS
A. ABX has rights in certain strains of XenoMouse
TM
Animals (as defined below) that are capable of producing human antibodies when immunized with an antigen.
B. PSMA desires to engage in a research program to immunize the XenoMouse Animals with the Antigen (as defined below) to generate human monoclonal antibodies to the Antigen.
C. ABX is willing to grant to PSMA, and PSMA desires to obtain, an exclusive license to engage in such program and an option to obtain an exclusive license to commercialize products comprising one or more antibodies derived from such research on the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties agree as follows:
1.
DEFINITIONS
For purposes of this Agreement, the terms set forth in this Section 1 shall have the respective meanings set forth below:
1.1
“
ABX In-License
” shall mean a license, sublicense or other agreement under which ABX acquired rights to the ABX Patent Rights or ABX Know-How Rights.
1.2
“
ABX Know-How Rights
” shall mean, collectively, all trade secret and other know-how rights (other than Research Program Know-How Rights) in the ABX Technology described in clauses (a) and (b) of Section 1.4 below or clause (d) of Section 1.4 below to the extent it relates to clauses (a) and (b) of Section 1.4 below.
1.3
“
ABX Patent Rights
” shall mean, collectively, (a) all patent applications (other than Research Program Patent Rights) owned or controlled by ABX heretofore or hereafter filed in any country which claim, and only to the extent they claim, the ABX Technology described in clauses (a) and (b) of Section 1.4 below or clause (d) of Section 1.4 below to the extent it relates to clauses (a) and (b) of Section 1.4 below; (b) all patents (other than Research Program Patent Rights) that have issued or in the future issue from any of the foregoing patent applications, including, without limitation, utility models, design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such patents and patent applications. The ABX Patent Rights shall include, without limitation, those patents and patent applications listed on the attached Exhibit C.
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1.4
“
ABX Technology
” shall mean, collectively, (a) all XenoMouse Animals (including, without limitation, those immunized with the Antigen hereunder), all other materials specified in Section 3.2 below and all uses thereof; (b) all XenoMouse Methods; (c) all materials (other than Research Program Technology) derived from the foregoing and all uses thereof; and (d) all information (other than Research Program Technology) regarding the foregoing (and all tangible and intangible embodiments thereof); in each case which is disclosed by ABX to PSMA under this Agreement or the Material Transfer Agreement or which is derived from activities under this Agreement or the Material Transfer Agreement. All ABX Technology shall be Confidential Information of ABX (unless included within a Confidentiality Exception, as defined below).
1.5
“
Affiliate
” shall mean, with respect to any person or entity, any other person or entity that controls, is controlled by or is under common control with such person or entity. For purposes of this Agreement, a person or entity shall be in “
control
” of an entity if it owns or controls at least fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority), or otherwise has the power to control the management and policies of such other entity.
1.6
“
Antibody
” shall mean a composition comprising a whole antibody, or any fragment thereof derived from the XenoMouse Animals or derived from any such antibody or fragment.
1.7
“
Antibody Cells
” shall mean all cells that contain, express or secrete antibodies or genetic materials that encode antibodies.
1.8
“
Antigen
” shall mean prostate specific membrane antigen, as well as fragments thereof, all as described in [*].
1.9
“
BLA
” shall mean a Biologics License Application, Product License Application, New Drug Application, or similar application for marketing approval of a product for use in the Commercial Field submitted to the FDA, or its foreign equivalent.
1.10
“
Commercial Field
” shall mean human therapeutic, preventative (prophylactic) and diagnostic medical use.
1.11
“
Confidential Information
” shall mean, with respect to a party, all information (and all tangible and intangible embodiments thereof), which is owned or controlled by such party, is disclosed by such party to the other party pursuant to this Agreement or the Material Transfer Agreement, and (if disclosed in writing or other tangible medium) is marked or identified as confidential at the time of disclosure to the receiving party or (if otherwise disclosed) is identified as confidential at the time of disclosure to the receiving party and described as such in writing within [*] after such disclosure.
[*] CONFIDENTIAL TREATMENT REQUESTED
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Notwithstanding the foregoing, Confidential Information of a party shall not include information which, and only to the extent, the receiving party can establish by written documentation (a) was known by the receiving party prior to disclosure of such information by the disclosing party to the receiving party; (b) was or becomes generally available in the public domain, without the fault of the receiving party; (c) has been received by the receiving party at any time from a source, other than the disclosing party, rightfully having possession of and the right to disclose such information free of confidentiality obligations; (d) becomes otherwise known by the receiving party free of confidentiality obligations prior to disclosure of such information by the disclosing party to the receiving party; or (e) has been independently developed by employees or others on behalf of the receiving party without access to or use of such information disclosed by the disclosing party to the receiving party (each of the foregoing exceptions being referred to herein as a “
Confidentiality Exception
”).
1.12
“
Core Third-Party Patents
” shall mean an issued, unexpired patent that is owned or controlled by a third party and is not licensed to ABX or an Affiliate of ABX, that has not been invalidated in a final unappealed or unappealable judgment by a court of competent jurisdiction, which patent covers XenoMouse Animals and which patent would be infringed by the sale of Products but for ABX or PSMA, as the same may be, obtaining a license under such patent (other than pursuant to this Agreement) in order to commercialize Products in the Commercial Field under this Agreement.
1.13
“
Cytogen
” shall mean Cytogen Corporation, a Delaware corporation.
1.14
“
Derived
” or “
derived
” shall mean obtained, developed, created, synthesized, designed or resulting from, based upon or otherwise generated (whether directly or indirectly, or in whole or in part).
1.15
“
FDA
” shall mean the Food and Drug Administration of the United States, or the successor thereto.
1.16
“
First Commercial Sale
” shall mean, with respect to any Product, the first sale of such Product by a party, its Affiliates or (sub)licensees to customers who are not Affiliates in any country after all applicable marketing and pricing approvals (if any) have been granted by the applicable governing health authority of such country.
1.17
“
Genetic Material
” shall mean a nucleotide or nucleic acid sequence (whether coding or noncoding and whether intact or a fragment).
1.18
“[*]
Agreement
” shall mean that certain [*] Agreement entered into by and between [*], effective as of [*], as the same may be amended from time to time.
1.19
“
IND
” shall mean an Investigational New Drug application filed with the FDA, or any corresponding filing or submission with any foreign regulatory authority required to commence human clinical testing of any product.
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1.20
“
Licensed ABX IP Rights
” shall mean ABX’s rights in the ABX Know-How Rights, ABX Patent Rights, Research Program Know-How Rights and Research Program Patent Rights.
1.21
“
Major Countries
” shall mean, collectively, [*].
1.22
“
Material Transfer Agreement
” shall mean the Material Transfer Agreement effective as of [*], between the parties.
1.23
“
Net Sales
” shall mean, with respect to any Product, the gross sales price of such Product in final form invoiced by PSMA, its sublicensees and their respective Affiliates to customers who are not Affiliates or sublicensees (or are Affiliates or sublicensees but are end users of such Product) less, to the extent actually paid or accrued by PSMA, its sublicensees or their respective Affiliates (as applicable), (a) normal and customary credits, allowances, discounts and rebates to, and chargebacks from the account of, such customers for spoiled, damaged, out-dated or returned Product; (b) normal and customary outer packing, freight and insurance costs incurred in transporting such Product in final form to such customers; (c) normal and customary cash, quantity and trade discounts, rebates and other price reductions for such Product given to such customers; (d) sales, use, excise, value-added and other taxes (but not income taxes of any kind) imposed upon the sale of such Product in final form to such customers; and (e) customs duties, surcharges and other governmental charges incurred in exporting or importing such Product in final form to such customers. Sales by PSMA, its Affiliates or sublicensees at or below the fully burdened cost of manufacturing such Product or purchasing such Product from a Third-Party manufacturer (plus, in each case, the costs of shipping), solely for the research or clinical testing of such Product or for indigent or similar public support or compassionate use programs, shall be excluded from the computations of Net Sales.
In the case of a Combination Product (as defined below) for which the agent or ingredient constituting a Product and each of the other active agents or active ingredients not constituting Products have established market prices when sold separately, Net Sales shall be determined by [*]. When such separate market prices are not established, then [*]. For purposes of the foregoing, “
Combination Product
” shall mean any product containing both an agent or ingredient, which constitutes a Product and one or more [*] which do not by themselves constitute Products, whether such [*] are packaged separately but sold together or are both packaged and sold together.
1.24
“
Phase II Clinical Trial
” shall mean a human clinical trial in any country that is intended to initially evaluate the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy requirements of 21 CFR 312.21(b), or its foreign equivalent.
1.25
“
Phase III Clinical Trial
” shall mean a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a BLA or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.
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1.26
“
Product
” shall mean any product that consists of or includes one or more Antibodies that binds to the Antigen and that constitutes Research Program Technology.
1.27
“
Progenics
” shall mean Progenics Pharmaceuticals, Inc., a Delaware corporation.
1.28
“
PSMA Know-How Rights
” shall mean, collectively, all trade secret and other know-how rights (other than Research Program Know-How Rights) specifically in PSMA Technology.
1.29
“
PSMA Patent Rights
” shall mean, collectively, (a) all patent applications (other than Research Program Patent Rights) owned or controlled by PSMA heretofore or hereafter filed in any country which specifically claim, and only to the extent they claim, PSMA Technology; (b) all patents that have issued or in the future issue from any of the foregoing patent applications, including, without limitation, utility models, design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such patents and patent applications.
1.30
“
PSMA Technology
” shall mean, collectively, all technology owned or controlled by PSMA (other than Research Program Technology) relating to the Antigen, including, without limitation, (a) the Antigen, (b) antibodies or fragments of antibodies that bind to the Antigen, (c) Genetic Materials encoding (a) or (b), (d) recombinant cells containing or expressing (a), (b) or (c), (e) all uses of the foregoing, including, without limitation, medical therapeutics, prophylactics and diagnostics, and (f) information regarding the foregoing (and all tangible and intangible embodiments thereof). All PSMA Technology shall be Confidential Information of PSMA (unless included within a Confidentiality Exception).
1.31
“
Research Field
” shall mean the immunization of XenoMouse Animals with the Antigen and the use of such immunized XenoMouse Animals and materials derived from such immunized XenoMouse Animals, in each case solely for the creation, identification, analysis, research, characterization and preclinical development (but not for the screening of compositions, other than Antibodies that specifically bind to the Antigen) of Antibodies for use in the Commercial Field.
1.32
“
Research Program
” shall mean the research and preclinical development program described in Section 3.1 below.
1.33
“
Research Program Know-How Rights
” shall mean, collectively, all trade secret and other know-how rights specifically in Research Program Technology.
1.34
“
Research Program Patent Rights
” shall mean, collectively, (a) all patent applications hereafter filed in any country which specifically claim and only to the extent they claim Research Program Technology; (b) all patents that have issued or in the future issue from any of the foregoing patent applications, including, without limitation, utility models, design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such patents and patent applications.
[*] CONFIDENTIAL TREATMENT REQUESTED
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1.35
“
Research Program Technology
” shall mean, collectively, (a) Antibodies that bind to the Antigen; (b) Genetic Materials that encode Antibodies that bind to the Antigen; (c) amino acid sequences of Antibodies that bind to the Antigen; (d) Antibody Cells that contain express or secrete Antibodies that bind to the Antigen or Genetic Materials that encode such Antibodies; (e) uses of the foregoing; and (f) information regarding the foregoing (and all tangible and intangible embodiments thereof); in each case that is derived from the activities under and in strict accordance with this Agreement or the Material Transfer Agreement. All Research Program Technology shall be Confidential Information of ABX and PSMA (unless included within a Confidentiality Exception).
1.36
“
Royalty Term
” shall mean, with respect to the sale of a Product in each country, the longer of (a) [*] from the date of the First Commercial Sale of such Product to be sold in such country, or (b) if, at the time of the First Commercial Sale of such Product in such country, any of the XenoMouse Animals, the use of the XenoMouse Animals hereunder or the manufacture, use, offer for sale, sale or import of such Product in such country would infringe a Valid Claim, the term for which such Valid Claim remains in effect and would be infringed.
1.37
“
Technology
” shall mean, collectively, ABX Technology, PSMA Technology and Research Program Technology.
1.38
“
Valid Claim
” shall mean either (a) a claim of an issued and unexpired patent included within the ABX Patent Rights or the Research Program Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or (b) a claim of a pending patent application included within the ABX Patent Rights or the Research Program Patent Rights, which claim was filed in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of such application and which application has not been pending itself or through claim of priority for more than [*].
1.39
“
XenoMouse Animals
” shall mean [*], and are intended to be immunized with the Antigen under this Agreement or the Material Transfer Agreement.
1.40
“
XenoMouse Methods
” shall mean, collectively, (a) all methods and techniques, currently known or developed during the term of the Research Program, specific to immunizing XenoMouse Animals with an antigen or deriving specifically therefrom Antibodies, Genetic Materials that encode Antibodies, or Antibody Cells that contain, express or secrete Antibodies or such Genetic Materials, and all uses thereof, which are disclosed by ABX to PSMA under this Agreement or the Material Transfer Agreement; and (b) all methods and techniques specific to immunizing XenoMouse Animals with an antigen or deriving therefrom Antibodies, Genetic Materials that encode Antibodies, or Antibody Cells that contain, express or secrete Antibodies or such Genetic Materials, and all uses thereof specific to XenoMouse Animals, which are derived from activities under this Agreement or the Material Transfer Agreement.
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2.
REPRESENTATIONS AND WARRANTIES
Each party represents and warrants to the other party as follows:
2.1
Organization
. Such party is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is organized.
2.2
Authorization and Enforcement of Obligations
. Such party (a) has the requisite power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; and (b) has taken all requisite action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms subject, as to enforcement, to bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles.
2.3
Consents
. All necessary consents, approvals and authorizations of all governmental authorities and other persons or entities required to be obtained by such party in connection with this Agreement have been obtained.
2.4
No Conflict
. The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws, regulations or orders of governmental bodies; and (b) do not conflict with, or constitute a default under, any contractual obligation of such party.
2.5
Further Representations, Warranties and Covenants of ABX
. ABX further represents and warrants to PSMA, as of the Effective Date, and covenants, that:
2.5.1
To the knowledge of ABX, there are no existing or threatened actions, suits or claims pending with respect to the subject matter hereof or the right of ABX to enter into and perform its obligations under this Agreement.
2.5.2
ABX has the full right and authority to grant the rights and licenses granted herein; it has not previously granted any rights under the Licensed ABX IP Rights in conflict with the rights and licenses granted to PSMA herein; ABX has no current actual knowledge of (a) any existing or threatened actions, suits or claims pending against ABX with respect to the Licensed ABX IP Rights, or (b) any Core Third-Party Patents that would prohibit PSMA’s use of the Licensed ABX IP Rights as licensed under this Agreement.
2.5.3
[*].
2.5.4
ABX has provided to PSMA copies of all applicable ABX In-Licenses as of the Effective Date (which copies are complete except as to the redaction of confidential financial information) setting forth all applicable limitations or restrictions on the Licensed ABX IP Rights and the XenoMouse Animals.
[*] CONFIDENTIAL TREATMENT REQUESTED
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2.5.5
ABX will use commercially reasonable efforts to maintain in force the [*] and the other ABX In-Licenses.
2.5.6
ABX shall, at the reasonable request of PSMA, discuss with PSMA ABX’s interpretation of material terms and conditions of ABX In-Licenses, including, without limitation, any limitations on ABX’s right to transfer or grant licenses or sublicenses to PSMA to any and all rights to technology within the scope of the ABX Patent Rights and/or ABX Know-How Rights under any ABX In-License.
2.5.7
ABX shall not agree to any termination, modifications or amendments to any ABX In-Licenses that would adversely affect PSMA’s rights under this Agreement without first obtaining PSMA’s prior written consent (which shall not be unreasonably withheld), and ABX shall notify PSMA as soon as practicable (if possible) of any material modification or amendment of any ABX In-License that materially affects (positively or negatively) PSMA’s rights or obligations under this Agreement and provide to PSMA a copy of such modification or amendment.
2.5.8
ABX shall promptly provide PSMA with a copy of any notice of default by ABX and/or its sublicensee under any ABX In-License, and of any notice of termination by any other party to any ABX In-License.
2.5.9
If any officer of ABX becomes actually aware of any third-party intellectual property that would constitute a Core Third-Party Patent, ABX agrees to inform PSMA of such third-party intellectual property and discuss with PSMA ways to resolve issues related thereto;
provided, however,
that the failure of ABX to so notify PSMA shall not form the basis for the termination of this Agreement by PSMA to the extent that ABX has exercised prudent and reasoned diligence in its efforts to keep PSMA so advised and such failure was not the result of willful misconduct or gross negligence on the part of ABX.
2.5.10
ABX will disclose to PSMA, at PSMA’s request, all methods, techniques and other information regarding the protocols described in Exhibit B that are used by ABX at the time of the delivery to PSMA of XenoMouse Animals in accordance with Section 3.2, and shall consult with PSMA as reasonably requested by PSMA with respect to the practice and application of such methods, techniques or information in the conduct of the Research Program.
2.5.11
During the term of this Agreement, ABX shall not (a) develop or sell any antibody or fragment thereof that binds to the Antigen, or enter into any agreement with any third party for the creation, research or development of such antibodies or fragments thereof, or (b) option, license or otherwise transfer intellectual property rights of any kind whatsoever, whether for research or commercial purposes, to any third party, to develop or sell any antibody or fragment thereof that binds to the Antigen, without the prior written consent of PSMA.
[*] CONFIDENTIAL TREATMENT REQUESTED
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2.6
DISCLAIMER OF WARRANTIES
. EXCEPT AS EXPRESSLY STATED HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING ANY MATERIALS, PRODUCTS OR LICENSED TECHNOLOGY, INCLUDING, WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING VALIDITY, ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. EXCEPT AS EXPRESSLY STATED HEREIN, ALL MATERIALS PROVIDED TO EITHER PARTY HEREUNDER ARE PROVIDED “AS IS.”
3.
RESEARCH PROGRAM
3.1
Conduct
.
3.1.1
During the term of the Research Program, PSMA shall conduct the Research Program as set forth in Exhibit A. During the term of the Research Program, PSMA may conduct, in its sole discretion, such additional preclinical research in the Research Field as PSMA reasonably desires;
provided, however,
prior to commencing such additional preclinical research, PSMA shall give prior written notice to ABX of the nature and scope of such additional preclinical research. PSMA shall provide the personnel, materials, equipment and other resources required to conduct the Research Program. PSMA shall conduct the Research Program in accordance with applicable scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws, regulations and current good laboratory practices.
3.1.2
Upon the mutual agreement of the parties, ABX shall conduct such immunizations of the XenoMouse with the Antigen as the parties mutually agree, and deliver to PSMA such Antibodies binding to the Antigen, Genetic Materials encoding such Antibodies and Antibody Cells that contain, express or secrete such Antibodies or Genetic Materials as the parties mutually agree. In such case, and in each such case at each party’s own cost, (a) PSMA shall deliver to ABX such PSMA Technology as reasonably necessary to conduct such activities; (b) ABX shall provide the personnel, materials, equipment and other resources required to conduct such activities; and (c) ABX shall conduct such activities in accordance with applicable scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws, regulations and current good laboratory practices. ABX’s right and obligation to conduct immunizations and other research under this Section 3.1.2 shall terminate on the earlier of (x) the delivery to PSMA of such Antibodies binding to the Antigen, Genetic Materials encoding such Antibodies and Antibody Cells that contain, express or secrete such Antibodies or Genetic Materials as the parties mutually agree prior to the commencement of such immunizations and other research, and (y) express written notice from either party to the other party of the termination of such immunizations and other research.
[*] CONFIDENTIAL TREATMENT REQUESTED
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3.2
Deliveries
.
3.2.1
Pursuant to the Material Transfer Agreement, ABX has delivered to PSMA, [*] XenoMouse Animals, together with the protocols described in Exhibit B for use in the Research Program. ABX shall deliver to PSMA, at the facilities of Progenics described in the previous sentence, the following materials in each case for use in the Research Program: (i) [*]; (ii) [*], upon the written request of PSMA; and (iii) [*], as requested by PSMA by giving not less than [*] prior written notice to ABX (which, to be effective, such written notice must be received by ABX not later than the date [*] following the Effective Date).
3.2.2
If, prior the [*] anniversary of the Effective Date, PSMA reasonably desires additional [*] under the Research Program, then subject to availability (as reasonably determined by ABX), ABX shall deliver to PSMA up to such additional quantity, not to exceed [*] as reasonably requested by PSMA [*] under the Research Program. Within [*] after receipt by PSMA of such [*], PSMA shall pay to ABX [*].
3.2.3
ABX acknowledges that the facilities described above in this Section 3.2 are owned by [*]. PSMA and Progenics represent and warrant that (a) Progenics is, and at all times during which Progenics is using such facilities shall be, the lessee from [*] of, and has the right to occupy and use, such facilities, (b) [*], and (c) [*] shall have no right, title or interest in or to the Technology.
3.3
Records
. PSMA shall maintain records, in reasonable detail and in good scientific manner appropriate for patent purposes, which shall be complete and accurate in all material respects and shall reflect work done and results achieved in the performance of the Research Program. ABX shall have the right, during normal business hours and upon reasonable notice, and at its sole expense to inspect and copy all such records of PSMA to the extent reasonably required in connection with the performance of its obligations or exercise of its rights under this Agreement. All such records shall be Confidential Information of PSMA, unless included within a Confidentiality Exception.
3.4
Reports
. During the term of the Research Program, PSMA shall keep ABX informed of the progress of its activities under the Research Program to the extent reasonably necessary for ABX to perform its obligations or exercise its rights under this Agreement. To this end, within [*] following the last day of each [*] during the term of the Research Program, PSMA shall prepare, and provide to ABX, a written summary report which shall describe the work performed to date under the Research Program and the results thereof. In addition, PSMA shall promptly notify ABX at such time as PSMA may select a compound candidate for clinical development. All such reports and other information so provided shall be Confidential Information of PSMA, unless included within a Confidentiality Exception.
3.5
Term of Research Program
. Unless this Agreement is earlier terminated, the term of the Research Program shall commence on [*], and shall continue through the earlier of (a) the [*] of the Effective Date, and (b) the date of the exercise by PSMA of the Option.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
3.6
Communication
. PSMA shall conduct the Research Program under the direct supervision of [*], or such other person proposed by PSMA and accepted by ABX, such acceptance not to be unreasonably withheld, who shall be the primary contact for PSMA regarding the Research Program. PSMA shall provide ABX with reasonable access to such persons, on reasonable notice and during normal business hours, to discuss the status of the Research Program and the results thereof.
4.
OPTION AND LICENSES
4.1
Research License
.
4.1.1
By ABX
. Subject to the terms and conditions of this Agreement, ABX hereby grants to PSMA an exclusive license under the Licensed ABX IP Rights (a) to use the XenoMouse Animals provided by ABX solely for immunization with the Antigen for the generation, creation and identification of Antibodies that bind specifically to the Antigen, (b) to make, have made by permitted transferees specified in Section 4.1.2 and use (but not to transfer (except as provided in Section 4.1.2 below), sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibody Cells that contain, express or secrete Antibodies that bind specifically to the Antigen, or Genetic Material that encodes such Antibodies, solely for use in the Research Field, (c) to make, have made by permitted transferees specified in Section 4.1.2 and use (but not to transfer (except as provided in Section 4.1.2 below), sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibodies that bind specifically to the Antigen, or Genetic Material that encodes such Antibodies, and (d) to engage in such other research and development activities as may be reasonably incidental to the foregoing, in each case solely for the research and development of such Antibodies in the Research Field. Except as expressly set forth in Section 4.3 or 8.1 below, PSMA shall not use the Licensed ABX IP Rights, the ABX Technology or any materials or information derived therefrom (including, without limitation, Antibodies, Genetic Material encoding Antibodies, and Antibody Cells) for any other use.
4.1.2
Sublicenses
. The license granted under Section 4.1.1 shall not include the right to grant sublicenses;
provided, however,
that PSMA shall have the right to transfer Antibodies that specifically bind to the Antigen, and Antibody Cells that contain, express or secrete such Antibodies, to third-party contractors, including, without limitation, academic or commercial collaborators performing research for or on behalf of PSMA and any manufacturer retained by PSMA to manufacture on their behalf research material, under the terms of written agreements having provisions regarding confidentiality, non-use and ownership of intellectual property consistent with those contained herein prohibiting the further transfer or disclosure of such Antibodies, Antibody Cells or the results of research with respect thereto to any third party (other than PSMA or ABX).
4.2
Option to Obtain Commercial License
. Subject to the terms and conditions of this Agreement, ABX hereby grants to PSMA the exclusive option (the “
Option
”) to obtain the commercial license under Section 4.3 below. The Option may be exercised by PSMA giving ABX express written notice (the “
Exercise Notice
”) of exercise at any time during the period (the “
Option Period
”) of [*] following the Effective Date. If PSMA fails to give the Exercise Notice to ABX on or before the expiration of the Option Period, this Agreement immediately shall terminate. Neither PSMA, its sublicensees nor their respective Affiliates shall submit an IND for any Antibody directed to the Antigen or Product, or administer to humans any Antibody direct to the Antigen or Product, unless and until PSMA has timely exercised the Option in accordance with this Section 4.2.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
4.3
Commercial License
. Subject to the terms and conditions of this Agreement, if PSMA has timely exercised the Option in accordance with Section 4.2 above, then effective upon the date of such exercise, ABX grants to PSMA an exclusive worldwide license, with the right to grant sublicenses, under Licensed ABX IP Rights to research, develop, make, have made, use, import, offer to sell and sell Products in the Commercial Field. Within [*] of granting any sublicense hereunder, PSMA shall provide ABX with at least the following information with respect to each sublicensee: (i) the identity of the sublicensee; (ii) a description of the Product and the rights granted to such sublicensee; and (iii) the countries in which the Products may be sold. Except as expressly set forth in this Agreement, PSMA shall not use the Licensed ABX IP Rights or the ABX Technology for any other use. Any such sublicense shall be subject and subordinate to the terms and conditions of this Agreement, and PSMA shall remain responsible for all payments due to ABX hereunder. Notwithstanding the foregoing, PSMA shall have no right to transfer, and ABX shall have no obligation to send, XenoMouse Animals to any sublicensee, without ABX’s prior written consent (which may be withheld in its sole discretion).
4.4
Grantback License
. The parties intend that this Agreement shall not restrict ABX’s freedom to operate regarding practice and commercialization of the ABX Technology (including, without limitation, XenoMouse Animals), except as expressly set forth herein regarding the Antibodies to the Antigen and the Antigen. Accordingly, in the event that any patent owned or controlled by PSMA, that (a) arises from use of the XenoMouse Animals, the ABX Technology or the Research Program Technology, or (b) uses data or information comprising, or derived from the use of, Research Program Technology, has application other than for the manufacture, use, sale, offer for sale or import of Products, PSMA hereby grants to ABX a royalty-free, perpetual, irrevocable license, with the right to grant and authorize sublicenses, under all such patents only for use in conjunction with the use of ABX Technology (including, without limitation, XenoMouse Animals) in all fields of use, other than (during the term of the licenses granted to PSMA under Section 4.3) the manufacture, use, sale, offer for sale or import of Products.
4.5
PSMA Exclusivity
.
4.5.1
At any time during which ABX is conducting immunizations or research pursuant to Section 3.1.2, neither PSMA nor its Affiliates shall create, research, develop, sell or otherwise commercialize any fully-human antibody or fragment thereof (other than an Antibody) that binds to the Antigen, or enter into any agreement with any third party for the creation, research, characterization, development, sale or other commercialization of such other fully-human antibodies or fragments thereof, without prior express written consent of ABX.
[*] CONFIDENTIAL TREATMENT REQUESTED
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4.5.2
Otherwise, during the term of this Agreement, neither PSMA nor its Affiliates shall create, research, develop, sell or otherwise commercialize any fully-human antibody or fragment thereof (other than an Antibody) that binds to the Antigen, or enter into any agreement with any third party for the creation, research, characterization, development, sale or other commercialization of such other fully-human antibodies or fragments thereof, without prior express written consent of ABX;
provided, however,
that such consent shall not be unreasonably withheld if (a) at the time of any request by PSMA for such consent, PSMA has satisfied its diligence obligations under Section 5.1.1, and (b) PSMA reasonably demonstrates that the development of such other fully-human antibody or fragment will not diminish, except for reasons outside of PSMA’s reasonably foreseeable control, the priority, personnel, funding and other resources dedicated to the future research, development and commercialization of Products hereunder.
5.
COMMERCIAL DILIGENCE
5.1
Diligence Efforts
.
5.1.1
PSMA (alone or with its Affiliates and/or sublicensees) shall use reasonable commercial efforts to, as expeditiously as possible, actively research, develop and obtain regulatory approvals to market in major markets throughout the world at least one Product hereunder.
5.1.2
Without limiting the generality of the obligations set forth in Section 5.1.1 above, and subject to the provisions of Section 5.1.3 below, PSMA, its sublicensee or their respective Affiliates shall file an IND with the FDA in the United States, or the foreign equivalent with the regulatory authority of competent jurisdiction in [*], for one or more Products under this Agreement within [*] after the effective date of the exercise of the Option in accordance with Section 4.2 above;
provided, however,
that such [*] period may be extended for [*] if, at the time of the expiration of the first [*] period, (a) PSMA reasonably demonstrates that (i) it has used commercially reasonable efforts to, as expeditiously as possible, actively research, develop and obtain regulatory approvals to market in major markets throughout the world at least one Product hereunder, and (ii) the reason for the failure to file an IND with the FDA in the United States, or the foreign equivalent with the regulatory authority of competent jurisdiction in [*], for one or more Products under this Agreement within the first [*] period are due to reasons outside of PSMA’s reasonably foreseeable control, and (b) PSMA has paid to ABX the [*] clinical milestone payment (for $[*]) listed under Section 6.2.1(a). After the filing of an IND for a Product, PSMA, its sublicensee or their respective Affiliates shall have an active IND and actively conduct clinical trials in pursuit of regulatory approval for such Product in the United States until such Product may be sold commercially in the United States.
5.2
Research and Development Reports
. After the term of the Research Program, and assuming exercise of the Option, within [*] after the end of each [*], PSMA shall prepare and provide ABX with a reasonably detailed written report of the activities conducted under this Agreement, including, without limitation, the general results, status and potential timing of research, preclinical and clinical testing and manufacture of Products, any anticipated IND filings for Products, and any anticipated filings of any BLA and/or similar foreign marketing application for Products. All such reports shall be Confidential Information of PSMA, unless included within a Confidentiality Exception.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
6.
PAYMENTS
6.1
License Fees
. PSMA shall pay to ABX the following nonrefundable and noncreditable license fees on or before the following dates (unless, as to any such payment, this Agreement shall have been terminated, prior to the applicable payment date):
6.2
Milestone Payments
.
6.2.1
Within [*] following the achievement of each of the following milestones, only with respect to the first Product to achieve such milestone, PSMA shall give written notice to ABX thereof and shall pay to ABX the corresponding nonrefundable and noncreditable milestone payments described below.
(a)
Clinical Milestones
:
(b)
Regulatory Milestones
:
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
6.2.2
If, at any time when any Clinical Milestone payment listed in Section 6.2.1 (a) above is due with respect to a Product, PSMA has not paid all other Clinical Milestone payments (if any) previously listed in Section 6.2.1(a) above with respect to such Product, then at such time PSMA shall pay all such unpaid milestone payments with respect to such Product. If, at the time of [*] by PSMA, its sublicensee or their respective sublicensees of a Product in a particular marketing region (
i.e.
, the [*]), PSMA has not paid all Regulatory Milestone payments for such marketing region (if any) listed in Section 6.2.1(b) above with respect to such Product, then at such time PSMA shall pay all such unpaid Regulatory Milestone payments that relate to such marketing region (if any) listed in Section 6.2.1(b) above with respect to such Product. PSMA shall not be obligated to pay any of the milestone payments set forth in Section 6.2.1 more than once regardless of the number of different Products that it may develop or commercialize.
6.3
Royalties
.
6.3.1
Within [*] following [*] of each Product in each country, PSMA shall give written notice to ABX thereof.
6.3.2
During the applicable Royalty Term, PSMA shall pay to ABX royalties equal to [*] of the aggregate Net Sales by PSMA, its sublicensees and their respective Affiliates of each Product in each country. PSMA may offset [*] of any royalty payments actually paid by PSMA to a third party (other than an Affiliate) in consideration for a license under any bona fide patent rights (other than to the extent such patent rights cover the Antigen, antibodies directed thereto generally or their use in the Commercial Field) which would be infringed by the manufacture, use or sale of a particular Product in a particular county, against the other royalty payments owing to ABX under this Section 6.3.2 on Net Sales of such Product in such county;
provided, however,
that the royalty payments owing to ABX under this Section 6.3.2 with respect to Net Sales of such Product in such country shall not be reduced pursuant to this provision in the aggregate to less than [*] of Net Sales of such Product in such country.
6.3.3
If PSMA, its sublicensees or their respective Affiliates sells a Product to a third party who also purchases other products or services from PSMA, its sublicensees or their respective Affiliates, and PSMA, its sublicensees or their respective Affiliates discounts the purchase price of such Product to a greater degree than it generally discounts the price of such Product to other customers, then in such case the Net Sales for the sale of such Product to such third party shall equal the arm’s-length price that third parties would generally pay for the Product alone when not purchasing any other product or service from PSMA, its sublicensee or their respective Affiliates. For purposes of this provision “discounting” includes establishing the list price at a lower-than-normal level.
6.3.4
If, in a given country commencing [*] after the date of [*] of a Product in such country, the market share in such country attributable to competition from [*] that is then being sold in such country equals or exceeds [*] of the total market share in such country for [*], as measured by a mutually acceptable publication or other mutually acceptable data, thereafter PSMA may reduce the royalties owing under Section 6.3.2 with respect to sales of such Product in such country by [*];
provided, however,
that the royalty payments owing to ABX under Section 6.3.2 with respect to sales of such Product in such country shall not be reduced pursuant to this Section 6.3.4 to less than [*] of Net Sales of such Product in such country.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
6.3.5
No provision of this Agreement shall be construed as requiring the payment of more than a single royalty for each Net Sale of a Product regardless of the number of patented or patentable claims or amount of know-how incorporated into such Product. ABX shall be solely liable for the payment of any royalties or other payments or fees owing under any ABX In-License as a result of the development, manufacture or sale of Products or the other activities of PSMA contemplated by this Agreement.
6.4
Royalty Reports
.
6.4.1
Within [*] after the end of each [*] during the term of this Agreement following [*] of a Product by PSMA, its sublicensees or their respective Affiliates, PSMA shall furnish to ABX a written report showing in reasonably specific detail, on a Product-by-Product and country-by-country basis, (a) [*]; (b) [*]; (c) [*]; and (d) [*].
6.4.2
With respect to sales of Products invoiced in United States dollars, all such amounts shall be expressed in United States dollars. With respect to sales of Products invoiced in a currency other than United States dollars, all such amounts shall be expressed both in the currency in which the sale is invoiced and in the United States dollar equivalent. The United States dollar equivalent shall be calculated using the exchange rate (local currency per US$1) published in [*] on the last business day of the applicable [*]. All royalties payable hereunder shall be calculated based on Net Sales expressed in United States dollars.
6.4.3
PSMA shall keep complete and accurate records in sufficient detail to properly reflect all gross sales and Net Sales and to enable the royalties payable (including the determination of, and the calculation of Net Sales of, Combination Products) to be determined.
6.4.4
All royalties shown to have accrued by each royalty report provided under this Section 6.4 shall be payable on the date such royalty report is due. Payment of royalties in whole or in part may be made in advance of such due date.
6.5
Audits
.
6.5.1
Upon the written request of ABX and not more than [*] in each [*], PSMA shall permit an independent certified public accounting firm of nationally recognized standing, selected by ABX and reasonably acceptable to PSMA, at ABX’s expense, to have access during normal business hours to such of the records of PSMA as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any year ending not more than [*] prior to the date of such request. ABX shall not be entitled to audit the same year more than once. The accounting firm shall disclose to ABX only whether the reports are correct or not and the specific details concerning any discrepancies. No other information shall be shared.
6.5.2
If such accounting firm concludes that royalties are owed with respect to the audited period in addition to those previously reported by PSMA to be owed, PSMA shall pay such additional royalties within [*] of the date ABX delivers to PSMA such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by ABX;
provided, however,
if the audit discloses that the royalties payable by PSMA for such period are more than [*] of the royalties actually paid for such period, then PSMA shall pay the reasonable fees and expenses charged by such accounting firm.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
6.5.3
ABX shall treat all financial information subject to review under this Section 6.5 as confidential, and shall cause its accounting firm to retain all such financial information in confidence and, at the request of PSMA, enter into a standard form of nondisclosure agreement prior to commencing an audit.
6.6
Withholding Taxes
. PSMA shall be entitled to deduct from the royalty payments otherwise due to ABX hereunder, the amount of any withholding taxes, value-added taxes or other taxes, levies or charges with respect to such royalty payments that are required to be withheld by PSMA, to the extent PSMA pays to the appropriate governmental authority on behalf of ABX such taxes, levies or charges. PSMA shall use reasonable efforts to minimize any such taxes, levies or charges required to be withheld on behalf of ABX by PSMA. PSMA promptly shall deliver to ABX proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto.
6.7
Payment Method
. All payments by PSMA to ABX hereunder shall be in United States Dollars in immediately available funds and shall be made by wire transfer from a United States bank located in the United States to such bank account as designated from time to time by ABX to PSMA.
7.
TECHNOLOGY
7.1
Ownership
. ABX shall solely own all right, title and interest in the ABX Technology and all patent rights and other intellectual property rights therein. PSMA shall solely own all right, title and interest in and to (i) the PSMA Technology, (ii) any technology or inventions (other than ABX Technology, PSMA Technology or Research Program Technology) arising out of the Research Program, and (iii) all patent rights and other intellectual property rights therein. ABX and PSMA shall jointly own all right title and interest in the Research Program Technology and all patent rights and other intellectual property rights therein. Each party shall have the right, subject to the provisions of this Agreement (including, without limitation, the exclusive licenses contemplated hereby), to freely exploit, transfer, license or encumber its rights in any Research Program Technology and the patent rights and other intellectual property rights therein without the consent of, or payment or accounting to, the other party;
provided, however,
that if this Agreement shall terminate for any reason, (a) PSMA shall not exploit or commercialize the Research Program Technology, the Research Program Know How Rights or the Research Program Patent Rights, directly or indirectly, including, without limitation, through sublicense, without the prior written consent of ABX, and (b) ABX shall not exploit or commercialize the Research Program Technology, without the prior written consent of PSMA. The transfer of physical possession of any Technology owned by, and the physical possession and use of any Technology by, PSMA or ABX, as the case may be, shall not be (nor be construed as) a sale, lease, offer to sell or lease, or other transfer of title of such Technology to PSMA or ABX, as the case may be.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
7.2
Assignment and Disclosure
. Each party shall cause all employees and others conducting work on its behalf under this Agreement to promptly disclose to the other party all Technology in which the other party has an ownership interest, and to assign any and all right, title and interest in all Technology and all patent rights and other intellectual property rights therein in accordance with this Agreement. Each party shall maintain records in sufficient detail and in good scientific manner appropriate for patent purposes to properly reflect all work done and results achieved in conducting its work hereunder, and shall respond to reasonable requests of the other party for information regarding Technology in which the other party has an ownership interest.
7.3
Certain Restrictions Regarding the XenoMouse Animals
. The transfer of the XenoMouse Animals to PSMA is made expressly subject to the following terms and conditions:
7.3.1
All XenoMouse Animals transferred to PSMA shall be the sole property of ABX, and the transfer of physical possession to PSMA, and/or possession or use by PSMA, of XenoMouse Animals shall not be, nor be construed as, a sale, lease, offer to sell or lease, or other transfer of title to or any interest in any XenoMouse Animals.
7.3.2
All XenoMouse Animals shall remain in the control of PSMA at the facility described in Section 3.2 hereof (or such other location as ABX agrees in writing), and subject to the provisions of Section 12.14, PSMA shall not (and shall not attempt or purport to) transfer the XenoMouse Animals to any third party (other than ABX).
7.3.3
PSMA shall not directly or indirectly use or attempt to use the XenoMouse Animals or any materials or information derived therefrom to reproduce, generate, create or produce, through breeding, reverse-engineering, genetic manipulation or otherwise, the XenoMouse Animals or other transgenic mice or other transgenic animals.
7.3.4
PSMA shall not use the XenoMouse Animals for any purpose other than immunization with the Antigen and shall not use the immunized XenoMouse Animals or any materials or information derived therefrom or from the use thereof for any purpose other than for the generation, purification, identification, research, evaluation, and preclinical development of Antibodies that specifically bind to the Antigen in accordance with the Research Program and the further research, development and commercialization of Products.
7.3.5
Except as expressly provided in this Agreement, PSMA shall not (and shall not attempt or purport to) assign, sell, have sold, lease, offer to sell or lease, distribute, license, sublicense or otherwise transfer title to or an interest in the XenoMouse Animals or Antibody Cells derived from the XenoMouse Animals.
7.3.6
Except as expressly set forth in this Agreement, PSMA shall not (and shall not attempt or purport to) assign, sell, have sold, lease, offer to sell or lease, distribute, license, sublicense or otherwise transfer title to or an interest in Antibodies, Genetic Materials derived from the XenoMouse Animals, or products comprising an Antibody or Genetic Material that encodes an Antibody.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
7.3.7
PSMA shall not directly or indirectly use the XenoMouse Animals to make or use antibodies to any antigen other than the Antigen.
7.4
Restrictions Regarding the Technology
. Except as otherwise expressly set forth in this Agreement:
7.4.1
Prior to the exercise of the Option: (i) PSMA shall not transfer or provide access to the ABX Technology, Research Program Technology or Products to any third party; and (ii) PSMA shall limit access to the ABX Technology, Research Program Technology or Products to those of its employees working on its premises to the extent such access is reasonably necessary to the conduct of its activities expressly authorized by this Agreement. Notwithstanding anything contained in this Agreement to the contrary, prior to the exercise of the Option, PSMA shall have the right to transfer Antibodies that bind specifically to the Antigen, and Antibody Cells that contain, express or secrete such Antibodies, to third-party contractors, including academic or commercial collaborators, performing research for or on behalf of PSMA under the terms of written agreements having provisions regarding confidentiality, non-use, and ownership of intellectual property consistent with those contained herein and prohibiting the further transfer or disclosure of such Antibodies, Antibody Cells or the results of research with respect thereto to any third party.
7.4.2
After the exercise of the Option: (a) PSMA shall not transfer or provide access to the ABX Technology or Research Program Technology to any third party other than to a sublicensee under Section 4.3; and (b) PSMA (or its sublicensee as applicable) shall limit access to the ABX Technology or Research Program Technology to those of its employees working on its premises to the extent such access is reasonably necessary to the conduct of its activities expressly authorized by this Agreement. Notwithstanding anything contained in this Agreement to the contrary unless this Agreement is terminated, after the exercise of the Option, (x) PSMA (or its sublicensee as applicable) shall have the right to transfer Antibodies that bind specifically to the Antigen, and Antibody Cells that contain, express or secrete such Antibodies, to (i) third-party contractors performing research for or on behalf of PSMA (or its sublicensee as applicable); (ii) potential or actual sublicensees, collaborators or partners; in each case under the terms of written agreements having provisions regarding confidentiality, non-use, and ownership of intellectual property consistent with those contained herein and prohibiting the further transfer or disclosure of such Antibodies, Antibody Cells or the results of research with respect thereto to any third party; and (y) PSMA (or its sublicensee as applicable) shall have the right to make, use, offer for sale, sell and import Products for use in the Field.
7.4.3
PSMA acknowledges that the ABX Technology and Research Program Technology is experimental in nature and may have unknown characteristics. PSMA shall use reasonable care in the use, handling, storage, transportation, disposition and containment of the ABX Technology and Research Program Technology.
7.4.4
Prior to the exercise of the Option, PSMA shall not (and shall not attempt or purport to) administer any materials comprising the ABX Technology or Research Program Technology to humans, or file or submit any regulatory application or other submission to obtain approval therefor.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
8.
PATENT RIGHTS
8.1
Prosecution and Maintenance
.
8.1.1
ABX shall have the sole right (but not the obligation), at its expense, to prepare, file, prosecute and maintain the ABX Patent Rights.
8.1.2
PSMA shall have the sole right (but not the obligation), at its expense, to prepare, file, prosecute and maintain the PSMA Patent Rights.
8.1.3
PSMA shall have the first right (but not the obligation), at PSMA’s sole expense, to prepare, file, prosecute and maintain the Research Program Patent Rights.
(a)
With respect to each patent application and patent within the Research Program Patent Rights, PSMA shall (i) provide ABX with any patent application filed by PSMA promptly prior to filing and receive and, in PSMA’s reasonable discretion, incorporate reasonable comments by ABX thereon; (ii) provide ABX with any patent application filed by PSMA promptly after such filing; (iii) provide ABX promptly with copies of all substantive communications received from or filed in patent office(s) with respect to such filings and receive and incorporate reasonable comments by ABX thereon; (iv) notify ABX of any interference, opposition, reexamination request, nullity proceeding, appeal or other interparty action, review it with the ABX as reasonably requested, and receive and, in PSMA’s reasonable discretion, incorporate reasonable comments by ABX thereon; and (v) a reasonable time prior to abandoning such patent applications or patents or otherwise taking or failing to take any action that would substantially affect the scope or validity of rights under such patent applications or patents, provide ABX with notice of such proposed action, review it with the ABX as reasonably requested, and receive and, in PSMA’s reasonable discretion, incorporate reasonable comments by ABX thereon.
(b)
ABX shall assist PSMA, upon request and at PSMA’s sole expense, and to the extent commercially reasonable, in preparing, filing or maintaining the patent applications and patents within the Research Program Patent Rights.
(c)
If PSMA does not intend to, or will not, commence or continue the filing, prosecution or maintenance of any patent application (or continuing or divisional application) or patent within the Research Program Patent Rights in any Major Country, PSMA shall give express written notice to ABX, not less than [*] before the last date to file any such patent application (or continuing or divisional application) in such Major Country within the Research Program Patent Rights or to make any filing or submission in connection with the prosecution or maintenance thereof. In such case, ABX shall have the right (but not the obligation), at its sole expense, to undertake the filing, prosecution and maintenance thereof, in which case such patent application and patent thereon in such Major Country shall be solely owned by ABX and shall not constitute Licensed ABX IP Rights.
(d)
If the Option expires unexercised or this Agreement is terminated, ABX shall thereafter have the right (but not the obligation), at its sole expense, to undertake the filing, prosecution and maintenance of the Research Program Patent Rights.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
8.2
Enforcement
.
8.2.1
ABX shall have the sole right (but not the obligation), at its expense, to enforce the ABX Patent Rights.
8.2.2
PSMA shall have the sole right (but not the obligation), at its expense, to enforce the PSMA Patent Rights.
8.2.3
PSMA shall have the first right (but not the obligation), at its sole expense, to enforce the Research Program Patent Rights. PSMA shall keep ABX informed, consult with ABX and consider in good faith the reasonable comments of ABX, both prior to and during any such enforcement. ABX shall assist PSMA, upon request and at PSMA’s sole expense, and to the extent commercially reasonable, in taking any action to enforce the Research Program Patent Rights.
(a)
If the Option expires unexercised or this Agreement is terminated, if PSMA fails to abate an infringement of the Research Program Patent Rights, or to file an action to abate such infringement, within [*] after a written request from ABX to do so, or if PSMA discontinues the prosecution of any such action after filing, ABX at its expense may, in its discretion, undertake such action as it determines appropriate to enforce the Research Program Patent Rights. In such case, PSMA shall assist ABX, upon request and at ABX’s sole expense, and to the extent commercially reasonable, in taking any action to enforce the Research Program Patent Rights.
(b)
All monies recovered upon the final judgment or settlement of any such action shall be used (i) first [*]; (ii) second [*]; and (iii) the remainder to the account of [*].
9.
CONFIDENTIALITY
9.1
Confidentiality
. During the term of this Agreement and for a period of [*] following the expiration or earlier termination hereof, unless otherwise agreed in writing by the parties, each party shall maintain in confidence the Confidential Information of the other party, shall not use or grant the use of the Confidential Information of the other party except as expressly permitted hereby, and shall not disclose the Confidential Information of the other party except on a need-to-know basis to such party’s directors, officers and employees, and to such party’s consultants and agents working on such party’s premises, to the extent such disclosure is reasonably necessary in connection with such party’s activities as expressly authorized by this Agreement. To the extent that disclosure to any person is authorized by this Agreement, prior to disclosure, a party shall obtain written agreement of such person to hold in confidence and not disclose, use or grant the use of the Confidential Information of the other party except as expressly permitted under this Agreement. Each party shall notify the other party promptly upon discovery of any unauthorized use or disclosure of the other party’s Confidential Information.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
9.2
Terms of Agreement
. Neither party shall disclose any terms or conditions of this Agreement to any third party without the prior written consent of the other party;
provided, however,
that a party may disclose the terms or conditions of this Agreement, (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary, and (b) subject to having first obtained written non-disclosure and non-use agreements no less protective than those contained in this Agreement, to a third party in connection with (i) an equity investment in such party, (ii) a merger, consolidation or similar transaction by such party, (iii) the sale of all or substantially all of the assets of such party or (iv) a potential or actual sublicensee, collaborator or partner. Notwithstanding the foregoing, the parties shall negotiate in good faith and agree upon the substance of information that can be used to describe the terms and conditions of this transaction, and each party may disclose such information, as modified by mutual written agreement the parties, without the consent of the other party, at any time following the earlier of (x) the determination that a party has produced under the Research Program one or more Antibodies that bind to the Antigen and that satisfy the functional criteria mutually agreed by the parties prior to the Effective Date, and (y) such time as such party is required by applicable securities laws or regulations to disclose such description of the terms and conditions of this transaction.
9.3
Permitted Disclosures
. The confidentiality obligations under this Section 9 shall not apply to the extent that a party, in the reasonable opinion of such party’s counsel, is required to disclose information by applicable law, regulation or order of a governmental agency or a court of competent jurisdiction, including, without limitation, a disclosure in connection with such party’s filing of a registration statement or other filing with the United States Securities and Exchange Commission;
provided, however,
that such party shall provide written notice thereof to the other party, consult with the other party with respect to such disclosure and provide the other party sufficient opportunity to comment on or object to any such disclosure or to request confidential treatment thereof. In addition, subject to having first obtained written nondisclosure and non-use agreements no less protective than those contained in this Agreement, PSMA may disclose Confidential Information to potential or actual sublicensees, collaborators and partners.
10.
INDEMNIFICATION
10.1
PSMA
. PSMA shall indemnify and hold harmless ABX, and its directors, officers, employees and agents, from and against all losses, liabilities, damages and expenses, including reasonable attorneys’ fees and costs (collectively, “
Liabilities
”), resulting from any claims, demands, actions or other proceedings by any third party to the extent resulting from to (a) the material breach of any representation, warranty or covenant by PSMA under this Agreement; (b) the use of the Licensed ABX IP Rights, ABX Technology or Research Program Technology by PSMA or its sublicensees; (c) the manufacture, use, sale, handling or storage of Products by PSMA, its sublicensees or their respective Affiliates, customers or end-users; or (d) the use of the Confidential Information of ABX by PSMA or its sublicensees;
provided, however,
that PSMA shall not be obligated to indemnify or hold harmless ABX for Liabilities to the extent that such Liabilities arise from: (i) the gross negligence or willful misconduct of ABX; (ii) claims that technology underlying the Licensed ABX IP Rights infringes Core Third-Party Patents; or (iii) claims that ABX has otherwise misappropriated the trade secrets or other proprietary information of third parties.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
10.2
ABX
. ABX shall indemnify and hold harmless PSMA, and its directors, officers, employees and agents, from and against all Liabilities resulting from any claims, demands, actions or other proceedings by any third party to the extent resulting from (a) the material breach of any representation, warranty or covenant by ABX under this Agreement; or (b) the use by ABX of the Confidential Information of PSMA;
provided, however,
that ABX shall not be obligated to indemnify or hold harmless PSMA for Liabilities to the extent that such Liabilities arise from: (i) the gross negligence or willful misconduct of PSMA; or (ii) claims that PSMA has misappropriated the trade secrets or other proprietary information of third parties.
10.3
Procedure
. If a party (the “
Indemnitee
”) intends to claim indemnification under this Section 10, it shall promptly notify the other party (the “
Indemnitor
”) in writing of any claim, demand, action or other proceeding for which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have the right to participate in, and, to the extent the Indemnitor so desires, to assume the defense thereof with counsel mutually satisfactory to the parties;
provided, however,
that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitor, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between the Indemnitee and any other party represented by such counsel in such proceeding. The obligations of this Section 10 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if materially prejudicial to its ability to defend such action, shall relieve the Indemnitor of any obligation to the Indemnitee under this Section 10, but the omission so to deliver written notice to the Indemnitor shall not relieve it of any obligation that it may have to any party claiming indemnification otherwise than under this Section 10. The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by this Section 10.
11.
TERM; TERMINATION
11.1
Term
. This Agreement shall commence on the Effective Date and, unless earlier terminated pursuant to Section 4.2 above or this Section 11, shall continue in effect until the expiration of PSMA’s obligation to pay royalties hereunder. Following the expiration of this Agreement on a Product-by-Product and country-by-country basis, PSMA’s license hereunder shall be fully paid-up and perpetual.
11.2
Termination for Breach
. If a party has materially breached any of its other obligations hereunder, and such material breach shall continue for [*] after written notice of such breach was provided to the breaching party by the nonbreaching party, the nonbreaching party shall have the right at its option to terminate this Agreement effective at the end of such [*] period.
11.3
Termination by PSMA
. PSMA may terminate this Agreement at any time upon [*] prior written notice to ABX.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
11.4
Effect of Expiration or Termination
.
11.4.1
Accrued Obligations
. Expiration or termination of this Agreement shall be without prejudice to any rights which shall have accrued to the benefit of a party prior to such expiration or termination. Without limiting the foregoing, Sections 4.4, 7, 8, 9, 10, 11.4 and 11.5 of this Agreement shall survive any expiration or termination of this Agreement.
11.4.2
Handling of Technology
. Except as otherwise expressly set forth in this Agreement, promptly upon the expiration or earlier termination of this Agreement, (a) PSMA shall destroy all physical embodiments of the Research Program Technology;
provided, however,
that PSMA shall deliver to ABX copies of any research results or reports that are reasonably necessary for ABX to exercise its rights under Section 8.1.3(d); (b) PSMA shall destroy or return to ABX (as ABX shall direct) all remaining ABX Technology; and (c) except as otherwise provided in clause (a), each party shall return to the other party all tangible items regarding the Confidential Information of the other party and all copies thereof;
provided, however,
that each party shall have the right to retain one (1) copy for its legal files for the sole purpose of determining its obligations hereunder.
11.4.3
Stock in Hand
. In the event this Agreement is terminated for any reason, PSMA and its Affiliates and sublicensees shall have the right, for a period not to exceed [*] after the date of such termination, to sell or otherwise dispose (consistent with all applicable regulations and law and subject to Sections 6.3 through 6.6 of this Agreement) of the stock of any Product subject to this Agreement then on hand.
11.4.4
Sublicenses
. Upon termination of this Agreement for any reason, any third-party licensee of PSMA which has not breached in any material respect its sublicense shall be entitled to receive a license directly from ABX granting rights substantially the same as those granted in such sublicense and containing obligations as a licensee similar to those set forth in this Agreement;
provided, however,
that (a) each such sublicensee shall expressly agree in writing to be bound by the terms and conditions of such direct license, and (b) the obligations of ABX under any such direct license shall be no greater than the obligations of ABX hereunder.
11.5
Certain Bankruptcy Matters
. In the event a party (the “
grantor
”) rejects this Agreement pursuant to Section 365 of the U.S. Bankruptcy Code, all rights and licenses granted under or pursuant to this Agreement by the grantor to the other party (the “
grantee
”) are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(52) of the U.S. Bankruptcy Code. The parties agree that the grantee, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. The parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against the grantor under the U.S. Bankruptcy Code, the grantee shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property upon written request therefor by the grantee. Such intellectual property and all embodiments thereof shall be promptly delivered to the grantee
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
(i) upon any such commencement of a bankruptcy proceeding upon written request therefor by the grantee, unless the grantor elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of the grantor, as the case may be, upon written request therefor by the grantee. The grantor shall not interfere with the rights of the grantee as provided in this Agreement, or any agreement supplementary hereto, to such intellectual property (including all such embodiments thereof), including any right of the grantee to obtain such intellectual property (or such embodiment) from any other entity.
12.
MISCELLANEOUS
12.1
Governing Law
. This Agreement shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to the conflicts of law principles thereof.
12.2
Waiver
. No waiver by a party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.
12.3
Assignment
. Neither this Agreement nor any right or obligation hereunder may be assigned or delegated, in whole or part, by either party without the prior express written consent of the other;
provided, however,
that either party may, without the written consent of the other, assign this Agreement and its rights and delegate its obligations hereunder in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger, consolidation, change in control or similar transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement. Any purported assignment in violation of this Section 12.3 shall be void. Notwithstanding the foregoing, ABX shall not be obligated without its consent to send XenoMouse Animals to any party other than PSMA, nor subject to the provisions of Section 12.14 shall PSMA have the right to transfer XenoMouse Animals to any other party without ABX’s prior written consent. The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the parties.
12.4
Independent Contractors
. The relationship of the parties hereto is that of independent contractors. The parties hereto are not deemed to be agents, partners or joint venturers of the others for any purpose as a result of this Agreement or the transactions contemplated thereby.
12.5
Further Actions
. Each party agrees to execute, acknowledge and deliver such further documents and instruments and to perform all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
12.6
Notices
. All requests and notices required or permitted to be given to the parties hereto shall be given in writing, shall expressly reference the section(s) of this Agreement to which they pertain, and shall be delivered to the other party, effective on receipt, at the appropriate address as set forth below or to such other addresses as may be designated in writing by the parties from time to time during the term of this Agreement.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
If to ABX:
Abgenix, Inc.
7601 Dumbarton Circle
Fremont, California 94555
Attn: President
with a copy to:
[*]
If to PSMA:
PSMA Development Company LLC
777 Old Saw Mill River Road
Tarrytown, New York 10591
Attn: Ronald J. Prentki
Representative
with a copy to:
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Attn: Philip K. Yachmetz
General Counsel
12.7
No Implied Licenses
. Only licenses and rights granted expressly herein shall be of legal force and effect. No license or other right shall be created hereunder by implication, estoppel or otherwise.
12.8
Force Majeure
. Nonperformance of a party (other than for the payment of money) shall be excused to the extent that performance is rendered impossible by strike, fire, earthquake, flood, governmental acts or orders or restrictions, failure of suppliers, or any other reason where failure to perform is beyond the reasonable control and not caused by the negligence, intentional conduct or misconduct of the nonperforming party;
provided, however,
that the nonperforming party shall use commercially reasonable efforts to resume performance as soon as reasonably practicable.
12.9
No Consequential Damages
. IN NO EVENT SHALL A PARTY BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 12.9 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 10 ABOVE.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
12.10
Third-Party Rights
. Notwithstanding anything to the contrary in this Agreement, the grant of rights by ABX under this Agreement shall be subject to and limited in all respects by the terms of the applicable ABX In-License(s) pursuant to which ABX acquired any Licensed ABX IP Rights, and all rights or sublicenses granted under this Agreement shall be limited to the extent that ABX may grant such rights and sublicenses under such ABX In-Licenses. Additionally, and without limiting the foregoing, the rights granted to PSMA hereunder, including, without limitation, any grant of “exclusive” rights, shall be subject to the rights granted to or retained by [*].
12.11
Complete Agreement
. This Agreement constitutes the entire agreement between the parties regarding the subject matter hereof, and all prior representations, understandings and agreements regarding the subject matter hereof (including, without limitation,, the Material Transfer Agreement), either written or oral, expressed or implied, are superseded and shall be and of no effect.
12.12
Counterparts
. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same agreement.
12.13
Headings
. The captions to the several sections hereof are not a part of this Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation.
12.14
Service Agreement
. The parties hereto acknowledge that the activities contemplated to be performed by PSMA under the Research Program are expected to be conducted on PSMA’s behalf by Progenics, under the terms of a written services agreement between PSMA and Progenics. In connection therewith, for so long and only so long as Progenics is obligated under the terms of such written services agreement to perform services for and on behalf of PSMA, PSMA may disclose to Progenics information regarding the Research Program, including its objectives, status and results, and information regarding this Agreement, in each case including Confidential Information, subject to first having obtained a written agreement containing non-disclosure and non-use provisions no less restrictive than those contained in this Agreement. Any action under the Research Program which may be taken by PSMA hereunder may be taken on its behalf by Progenics pursuant to such written services agreement. PSMA shall be liable for all acts and omissions of Progenics, its employees, consultants and agents to the same extent as if such acts and omissions had been made by PSMA or its employees. Progenics has, and at all times during the term of this Agreement shall have and acquire, no right, title or interest in or to the ABX Technology, the Research Program Technology or any other results of the Research Program or the other activities conducted under this Agreement.
12.15
Members of PSMA
. PSMA has informed ABX that PSMA is a Delaware limited liability company, the outstanding membership interest of which are owned fifty percent (50%) by Progenics and fifty percent (50%) by Cytogen. Notwithstanding anything in this Agreement to the contrary, PSMA and Progenics may disclose information regarding the Research Program, including its objectives, status and results, and information regarding this Agreement, in each case including Confidential Information, to Cytogen subject to first having obtained a written agreement containing non-disclosure and non-use provisions no less restrictive than those contained in this Agreement.
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective duly authorized officers as of the day and year first above written.
ABGENIX, INC.
|
By:
|
_____________________________
|
PSMA DEVELOPMENT COMPANY, LLC
|
By:
|
_____________________________
|
To the extent Progenics performs any services on behalf of PSMA as provided in Section 12.14, Progenics hereby agrees to be bound by the terms of this Agreement applicable to such services.
PROGENICS PHARMACEUTICALS, INC.
|
By:
|
_____________________________
|
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
EXHIBIT A
RESEARCH PROGRAM
[*]
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
EXHIBIT B
ABX PROTOCOLS
[*]
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
EXHIBIT C
ABX PATENT RIGHTS
I.
Owned by Abgenix
[*]
II.
Licensed to ABX
[*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION