Exhibit 10.28
COLLABORATION AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
HYSEQ, INC.
(d.b.a. HYSEQ PHARMACEUTICALS)
JANUARY 8, 2002
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (the "Agreement") is made effective as of
January 8, 2002 (the "Effective Date") by and between AMGEN INC., a Delaware
corporation having its principal place of business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("Amgen") and HYSEQ, INC., d.b.a. HYSEQ
PHARMACEUTICALS, a Nevada corporation having its principal place of business at
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("Hyseq"). Amgen and Hyseq
are sometimes referred to herein individually as a "Party" and collectively as
the "Parties".
RECITALS
WHEREAS, Amgen has developed certain technology and know-how which
relates to a protein known as Alfimeprase;
WHEREAS, Hyseq has technology and know-how and significant experience
and expertise in the research and development of pharmaceutical products that
may be particularly well suited to develop and market a product such as
Alfimeprase;
WHEREAS, Hyseq now wishes to collaborate with Amgen in the further
research, development and commercialization of Alfimeprase on the terms and
conditions set forth herein;
WHEREAS, the Parties believe it to be in their mutual interest to
combine their mutual experience, know-how and expertise and to grant each other
such intellectual property licenses and other rights as are necessary to
diligently continue the research and development begun by Amgen so as to
commercialize Alfimeprase or one or more products resulting from the aforesaid
continuing research and development.
NOW THEREFORE, based on the foregoing premises and the mutual covenants
and obligations set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used but not otherwise defined herein have the
meanings provided in EXHIBIT A hereto.
ARTICLE 2
COLLABORATION GOVERNANCE
2.1 COLLABORATION. The Parties agree to jointly Develop and
Commercialize Collaboration Products under the terms of this Agreement.
1.
2.2 STEERING COMMITTEE. As soon as practicable following the Effective
Date, the Parties shall establish a Committee (the "Steering Committee")
comprised of two (2) senior officers or managers from each of Hyseq and Amgen.
The Steering Committee shall follow the organizational and meeting procedures
set forth in Section 2.4.
2.3 STEERING COMMITTEE RESPONSIBILITIES. The Steering Committee shall be
responsible for overseeing and managing the collaboration, including, without
limitation the following functions:
(a) determining the overall strategy for the Development, manufacturing
and Commercialization of all Collaboration Products in the manner contemplated
by this Agreement;
(b) establishing a governance structure for and coordinating the
activities of the Parties hereunder including, to the extent necessary,
establishing certain operating committees to oversee certain activities such as
Development, finance, manufacturing and Commercialization (the operating
committees shall be subordinate to the Steering Committee and shall include
individuals with expertise and responsibilities in the relevant areas);
(c) reviewing and approving the Program Plan;
(d) reviewing the activities and Collaboration Expenditures compared to
the Program Plan and determining whether any changes are necessary, given the
then-current progress and results;
(e) approving target product profiles for Collaboration Products,
including indications, in addition to peripheral arterial occlusion (PAO), for
which the Collaboration Products will be further Developed and Commercialized;
(f) determining which Collaboration Products will be Developed and
Commercialized;
(g) facilitating the exchange of all data, Information, Materials or
results relating to Collaboration Products, including developing report formats
to facilitate the respective activities and responsibilities of the Parties; and
(h) performing such other functions as appropriate to further the
purposes of the collaboration as determined by the Parties.
2.4 DECISION MAKING; ADMINISTRATIVE MATTERS.
(a) Decision Making. All decisions of the Steering Committee shall be
made by the [***] of Hyseq and Amgen, with the representatives of each Party who
are members of the Steering Committee collectively having one vote in any matter
requiring the approval of the Steering Committee.
(b) Dispute Resolution. If the Steering Committee is unable to reach
[***] agreement on any issue within a period of forty-five (45) days after
receiving notification of such dispute
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2.
regarding any aspect under this Agreement, then the final decision-making
authority for any such matter shall be determined, depending upon the subject
matter of the unresolved issue, as follows:
(i) Development decisions: Other than as set forth in this
Section 2.4(b)(i), Hyseq shall have final decision-making authority with
respect to the generation and implementation of the Development Plan,
after reasonably considering in good faith any concerns raised or
comments provided by Amgen. This authority shall apply to all
Development decisions, with the exception of the following issues, which
will at all times require [***] consent of the Steering Committee:
setting product specifications and product forecasts (as detailed in the
Development Plan and/or Commercial Plan sections of the Program Plan);
setting the [***] charged to the Operating Profit or Loss account; and
deciding whether to [***] for the generation of sufficient clinical data
to file for and obtain Regulatory Approval of a first Collaboration
Product.
(ii) Manufacturing decisions: Other than as set forth in this
Section 2.4(b)(ii), the Manufacturing Lead shall have final
decision-making authority with respect to the generation and
implementation of the Process Development/Manufacturing Plan, after
reasonably considering in good faith any concerns raised or comments
provided by the other Party. This authority shall apply to all
manufacturing decisions, with the exception of the following issues,
which will at all times require [***] consent of the Steering Committee:
setting product specifications and product forecasts (as detailed in the
Development Plan and/or the Commercial Plan sections of the Program
Plan); and setting the [***] charged to the Operating Profit or Loss
account.
(iii) Regulatory decisions: Other than as set forth in this
Section 2.4(b)(iii), the Regulatory Lead for an indication shall have
final decision-making authority with respect to the generation and
implementation of the Regulatory Plan during the time period for which
it is responsible (i.e. pre- or post-Transition Date), after reasonably
considering in good faith any concerns raised or comments provided by
the other Party. This authority shall apply to all regulatory decisions,
with the exception of the following issues, which will at all times
require [***] consent of the Steering Committee: setting the [***]
charged to the Operating Profit or Loss account; and Recalling
Collaboration Products (provided that regulatory timeframes or safety
considerations do not require early action by a Party before action by
the Steering Committee).
(iv) Commercialization decisions: Other than as set forth in
this Section 2.4(b)(iv), the Commercial Lead shall have final
decision-making authority with respect to the generation and
implementation of the Commercial Plan, after reasonably considering in
good faith any concerns raised or comments provided by the other Party.
This authority shall apply to all Commercialization decisions, with the
exception of the following issues, which will at all times require [***]
consent of the Steering Committee: setting the [***] charged to the
Operating Profit or Loss account.
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3.
(v) All other decisions: The Parties shall attempt to resolve
disputes concerning matters not listed in (i)-(iv) above in accordance
with the provisions of Article 17, below.
For the avoidance of doubt, control of a final decision-making authority for any
aspect of the Program Plan as set forth in Sections 2.4(b)(i)-(iv) shall not
relieve the Party with such control from any of its representations, warranties
and/or covenants as set forth in Article 13 nor shall it enable such Party to
unilaterally modify or amend the terms of this Agreement.
(c) Administrative Matters. The Steering Committee shall establish its
own procedural rules for its operation, consistent with the terms of this
Section 2.4. A chairperson for the Steering Committee shall be appointed from
among its members. The chairperson shall be appointed on an annual basis and
shall alternate each Calendar Year between a Hyseq representative and an Amgen
representative, with Hyseq being responsible for designating the chairperson for
the first Calendar Year after the Effective Date. The chairperson shall be
responsible for calling meetings of the Steering Committee and for leading the
meetings. A Steering Committee member of the Party hosting a meeting of the
Steering Committee shall serve as secretary of that meeting. Within ten (10)
business days following each meeting, the secretary of such meeting shall
prepare and distribute to all members of the Steering Committee the minutes of
the meeting. Such minutes shall provide a reasonably detailed description of the
meeting discussions and a list of any actions, decisions or determinations
approved by the Steering Committee. The minutes of each Steering Committee
meeting shall be approved or disapproved, and revised as necessary, at the next
meeting. Final minutes of each meeting shall be distributed to the members of
the Steering Committee by the chairperson.
(d) Meetings. The Steering Committee shall meet at least semi-annually
per Calendar Year. Such meetings shall alternate between Amgen and Hyseq
locations and be held at such times as are mutually agreed upon by the Steering
Committee and shall be conducted in person, unless approved by the chairperson
to conduct such meetings by video conference or teleconference. The first
meeting shall be held at Amgen's facilities.
(e) Attendance at Meetings. If a Party's representative is unable to
attend a meeting, such Party may designate an alternate representative to attend
such meeting. In addition, each Party may, at its discretion (and with the
consent of the other Party), invite additional employees, consultants or
scientific advisors to attend any Steering Committee meetings.
ARTICLE 3
DEVELOPMENT
3.1 DEVELOPMENT. Following the Effective Date, the Parties shall
undertake Development of the Collaboration Products in the manner contemplated
in this Agreement. To the extent applicable, each Party agrees to maintain all
regulatory and governmental permits, licenses and approvals and to comply with
all laws, rules and regulations that are applicable to each such Party's
activities and the particular stage of Development of the Collaboration
4.
Products including, without limitation, GLPs, GCPs and GMPs, as such standards
are defined in accordance with the applicable guidance and regulations including
the International Conference of Harmonization (ICH), the U.S. Food, Drug and
Cosmetic Act, 21 C.F.R.(s) 210 et seq. and the regulations promulgated
thereunder, and any amendments thereto and the regulations promulgated
thereunder, and the equivalent laws, rules and regulations of other countries in
the Territory.
3.2 HYSEQ RESPONSIBILITIES.
(a) Hyseq shall be designated as the "Development Lead." Hyseq shall be
responsible for preparing and submitting the Development Plan section of the
Program Plan to and for approval by the Steering Committee, and shall update the
Development Plan on an annual basis, in time for the annual budget cycle of each
of the Parties; provided however, it is acknowledged and agreed that the
Development Plan may need to be modified from time-to-time between annual
updates, based upon the results of clinical trials and other unanticipated
events. [***]. Hyseq shall have responsibility for all aspects of Developing the
Collaboration Products in the Territory, including making all strategic and
tactical decisions with respect thereto in accordance with the Development Plan
and establishing the methods and means by which it performs its services under
this Agreement (including the management of permitted subcontractors, pursuant
to Section 18.7). Hyseq [***] in accordance with the Development Plan approved
by the Steering Committee, [***].
(b) Upon the request of Hyseq, Amgen [***], to assume certain
Development responsibilities in support of Hyseq's carrying out the activities
within the Development Plan. Prior to assuming any such responsibility, Amgen
shall provide to Hyseq, for approval by the Steering Committee and inclusion
within the Development Plan, the estimated budget for carrying out any such
responsibility and may thereafter charge the Operating Profit or Loss account
for any approved expenditures.
(c) Each Party shall be responsible for carrying out its assigned
activities in accordance with the Development Plan. These activities shall
include, without limitation (i) investigating peripheral arterial occlusion as
the primary indication for which Collaboration Products will be developed, and
identifying other indications for which Collaboration Products will be
Developed; (ii) identifying and carrying out all major Development tasks to be
conducted prior to submission of filings for Regulatory Approval of a
Collaboration Product for a particular indication; (iii) identifying key
Development objectives, expected associated resources, risk factors, timelines,
go/no go decision points and relevant decision criteria; (iv) carrying out all
aspects of (e.g., designing studies and protocols and conducting), and preparing
the associated Regulatory Plan for, all clinical trials necessary to obtain
Regulatory Approval for each indication pursued, as well as establishing new
dosage forms, new formulations or other enhancements of approved Collaboration
Products (but excluding Post-Approval Clinical Studies) including, but not
limited to (1) establishing/contracting with clinical sites, investigators and
CROs, (2) enrolling clinical study patients, (3) organizing investigator
meetings, scientific meetings, advisory panel workshops and regulatory meetings,
and (4) analyzing, summarizing
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and presenting clinical study results; (v) performing any other additional
research and pre-clinical research in support of the clinical development of
Collaboration Products; (vi) forecasting clinical manufacturing production
requirements; (vii) Regulatory Authority reporting on study design, study
outcome, other communications and regulatory filings (to the extent not covered
by a Regulatory Plan); (viii) establishing material transfer and collaboration
agreements, pursuant to Section 9.13, prior to the Transition Date of the first
Collaboration Product; and (ix) preparing publications and presentations of data
regarding Collaboration Products generated prior to the Transition Date of a
Collaboration Product.
3.3 INFORMATION AND DATA. Hyseq shall promptly disclose to Amgen all
material scientific or technical information relating to any Collaboration
Product that it discovers in the course of Development activities, promptly
after it is learned or its materiality is appreciated. Hyseq shall maintain a
database which contains (a) all clinical trial data accumulated from clinical
trials of all Collaboration Products, (b) all safety data, and (c) all adverse
reaction information for all Collaboration Products during Development. On an
annual basis, Hyseq shall provide Amgen with written summaries of all
pre-clinical and clinical data generated by Hyseq with respect to Collaboration
Products, as well as all such pre-clinical and clinical data in computer
readable format requested by Amgen. Amgen shall be entitled to have access,
during regular business hours and upon reasonable advance notice, to such
pre-clinical and clinical data maintained by Hyseq (including all clinical trial
databases, in a computer readable format requested by Amgen). The Parties shall
each own an undivided one-half (50:50) interest in all data and Information
generated as part of the Development of Collaboration Products, including all
data accumulated from all clinical trials of each Collaboration Product.
3.4 AUDIT. Amgen shall have the right to conduct reasonable quality
assurance audits with respect to all facilities, operations and laboratories
(and any records related thereto) of Hyseq or Third Party subcontractors, where
Development activities are conducted, as is reasonably necessary solely for the
purpose of verifying Hyseq's conformance with applicable cGMP, cGLP, cGCP and
other regulatory requirements. Hyseq shall have the right to conduct reasonable
quality assurance audits with respect to all facilities, operations and
laboratories (and any records related thereto) of Amgen where Development
activities are conducted, [***] to permit Hyseq to carry out its activities as
Development Lead and/or Regulatory Lead and/or Commercial Lead (as determined
hereunder). Such audits shall be conducted upon reasonable notice during
reasonable business hours.
ARTICLE 4
REGULATORY
4.1 REGULATORY LEAD. The Development Lead (Hyseq) shall be responsible
for all regulatory matters for Development, i.e., concerning each indication for
a Collaboration Product prior to the Transition Date for such Collaboration
Product in such indication. On an indication-by-indication basis, the Commercial
Lead (as determined pursuant to Sections 5.1 and 5.8) shall be responsible for
all regulatory matters for Commercialization, i.e., concerning each indication
for a Collaboration Product upon the Transition Date for such Collaboration
Product in each such indication including, without limitation, the filing and
support of any Drug Approval
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Applications and matters concerning Post-Approval Clinical Studies. Each Party
having responsibility for regulatory matters during the time periods (pre- and
post-Transition Date) as set forth in this Section 4.1 shall be designated as
the "Regulatory Lead" for such regulatory matters during such time periods.
4.2 RESPONSIBILITIES AND RIGHTS OF REGULATORY LEAD. During the time
period for which it is responsible for regulatory matters, the Regulatory Lead
for an indication shall be the trial sponsor with Regulatory Authorities and
shall be responsible for preparing and submitting, with respect to such
indication, a draft Regulatory Plan section of the Program Plan to the Steering
Committee for its approval, as well as updating the Regulatory Plan on an annual
basis, in time for the annual budget cycle of each of the Parties; provided
however, it is acknowledged and agreed that the Regulatory Plan may need to be
modified from time-to-time between annual updates, based upon the results of
clinical trials and other unanticipated events. [***]. With respect to
regulatory matters for which it is responsible, the Regulatory Lead for an
indication shall have the right to monitor, review and direct all aspects of
regulatory matters regarding Collaboration Products for such indication in the
Territory, including making all strategic and tactical decisions with respect
thereto (in accordance with the Regulatory Plan) and establishing the methods
and means by which it performs such services, including the management of
permitted subcontractors, pursuant to Section 18.7. In accordance with Section
4.7, the Regulatory Lead shall have responsibility for all associated official
correspondence, communications and Regulatory Filings with Regulatory
Authorities regarding such matters. The Regulatory Lead shall not transfer title
in or otherwise attempt in any manner to dispose of any Regulatory Filings or
Regulatory Approvals or other governmental licenses, approvals or certificates
for Collaboration Products in the Territory, or otherwise impair the other
Party's rights in such Regulatory Filings or Regulatory Approvals, or other
governmental licenses, approvals or certificates.
4.3 TRANSFER OF IND. As of the Effective Date, Amgen owns in its own
name a certain IND filing for Alfimeprase in the Territory, which is set forth
in Exhibit C. Subject to Amgen's rights pursuant to this Agreement, Amgen hereby
assigns to Hyseq Amgen's entire right, title and interest in and to such IND set
forth in Exhibit C; Hyseq shall then assume all responsibility (and become the
sponsor and party of record) for regulatory matters therewith, and shall
thereafter be designated the "Regulatory Lead" therefor. Hyseq, in consultation
with Amgen, shall prepare, file and maintain all regulatory documentation and
perform all applicable regulatory activities for each Collaboration Product
prior to its respective Transition Date. No later than [***] after the Effective
Date, Amgen shall notify Regulatory Authorities in the Territory of the transfer
and [***] shall take all actions reasonably necessary to effect or evidence the
transfer of such IND to Hyseq. For the avoidance of doubt, the transfer of such
IND shall not be effective to transfer to Hyseq the ownership of or the right to
practice any Amgen Material and Manufacturing Information. Notwithstanding
anything to the contrary in this Agreement, Hyseq shall have the right to
receive from Amgen, and Amgen shall provide to Hyseq, any regulatory data or
information to which Hyseq, as the holder of any IND in the Territory, is
required by law, rule, regulation or a Regulatory Authority having jurisdiction
in the Territory, to have access, or which Hyseq reasonably requires in order to
carry out its responsibilities as Development Lead and/or Regulatory Lead and/or
Commercial
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Lead; [***] such law, rule, regulation or Regulatory Authority [***] carry out
its responsibilities as Development, Regulatory and/or Commercial Lead.
4.4 DRUG APPROVAL APPLICATIONS.
(a) After the Transition Date for a Collaboration Product in an
indication, the Commercial Lead shall become the Regulatory Lead with respect to
such indication, with responsibility for filing Drug Approval Applications and
seeking Regulatory Approvals for such Collaboration Product in the Territory.
(b) To the extent that it is the Commercial Lead, Amgen shall have the
right to receive from Hyseq, and Hyseq shall provide to Amgen any regulatory
data or information which Amgen requires to file the Drug Approval Applications,
or to which Amgen, as the holder of any Drug Approval Applications in the
Territory, is required by law, rule, regulation or a Regulatory Authority having
jurisdiction in the Territory, to have access, or which Amgen reasonably
requires in order to carry out its responsibilities as Commercial Lead; but
Amgen shall only be entitled to use such regulatory data or information to the
extent it is reasonably required for Amgen to carry out its responsibilities as
Commercial Lead or as a Regulatory Lead. To the extent that Amgen is the
Commercial Lead, Hyseq shall also grant Amgen a right of access and reference to
(and name it a party of record on) all INDs and shall promptly notify Regulatory
Authorities in the Territory of (and as soon as is reasonably practicable
thereafter take all actions reasonably necessary to effect or evidence) the
right of access and reference to (and naming Amgen as a sponsor and party of
record on) such INDs.
(c) Prior to submitting any Drug Approval Application the Commercial
Lead, through the Steering Committee, shall consult with the other Party about
the content and scope of such Drug Approval Applications. The Commercial Lead
shall own (be the sponsor and party of record of) all Drug Approval Applications
for Collaboration Products in the Territory.
4.5 TRANSFER OF REGULATORY FILINGS AND REGULATORY APPROVALS. If
ownership of a Regulatory Filing or Regulatory Approval in any country cannot be
transferred from the owning Party to the other Party pursuant to any one of
Sections 4.3, 4.4(b), 5.8(b), 16.9(a)(iii) or 16.9(c)(ii), the owning Party
shall grant to the other Party an exclusive right of access and reference to
such Regulatory Filing or Regulatory Approval in such country in order to enable
the other Party to become a sponsor and party of record of an IND. If such right
of access and reference is not sufficient to permit the other Party to file a
Drug Approval Application and receive Regulatory Approval or to Develop,
manufacture or Commercialize a Collaboration Product, the owning Party shall
provide the other Party with any and all information necessary for the other
Party to carry out such activities and to receive Regulatory Approval in its own
name.
4.6 ADVERSE EVENT REPORTING; CUSTOMER COMPLAINTS.
(a) Each Party shall maintain a record of all non-medical and medical
product-related complaints and reports of adverse events that it receives with
respect to any Collaboration Product. Each Party shall notify the other Party of
any complaint received by it and, within
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[***] (but, in the event of serious adverse events, [***]) of the initial
receipt, provide the other Party with a copy of such complaint(s) and adverse
event reports.
(b) On an indication-by-indication basis, after the Effective Date and
prior to the Transition Date for a Collaboration Product in an indication, Hyseq
(as the IND sponsor and party of record) shall be responsible for reporting to
Regulatory Authorities any adverse experience and safety issues for such
Collaboration Product in compliance with the requirements of the U.S. Food, Drug
and Cosmetic Act, 21 USC Section 321 et seq., the regulations promulgated
thereunder, and the equivalent, laws, rules and regulations in the Territory and
shall promptly thereafter provide Amgen with a copy of such report.
(c) On an indication-by-indication basis, after the Transition Date for
a Collaboration Product, the Commercial Lead shall be responsible (as the
sponsor and party of record) for reporting to Regulatory Authorities any adverse
experience and safety issues regarding such Collaboration Product in compliance
with the requirements of all applicable laws and regulations (including the FD&C
Act and the PHS Act, and any amendments thereto and the regulations promulgated
thereunder, and the equivalent laws, rules and regulations of other countries in
the Territory) and shall promptly thereafter provide the other Party with a copy
of such report. To the extent Hyseq is conducting clinical studies for a new
indication (after the Transition Date for such Collaboration Product in a
different indication), Hyseq shall provide Amgen (to the extent Amgen is the
Commercialization Lead) with a report of any related adverse events that need to
be reported to the Regulatory Authorities.
4.7 COMMUNICATIONS.
(a) The Regulatory Lead for an indication shall have exclusive
responsibility for all correspondence and for any official of communication
(except as the other Party may be required by applicable laws or regulations or
a Regulatory Authority to communicate) regarding such indication with applicable
Regulatory Authorities in the Territory and the other Party shall have the right
to be present (and to participate at the request of the Regulatory Lead or the
Regulatory Authority) at all face-to-face meetings and scheduled conference
calls regarding significant clinical events or decisions. If one Party is
required by applicable laws or regulations or a Regulatory Authority to disclose
information to such Regulatory Authority having jurisdiction in the Territory,
including information regarding the manufacture of Collaboration Products, such
Party will notify the other Party before communicating with the Regulatory
Authority.
(b) After the Effective Date and prior to the Transition Date for a
Collaboration Product in an indication, and with respect to such indication,
Amgen (to the extent it is the Manufacturing Lead) will reasonably cooperate
with Hyseq to make and provide copies of any direct communications by Amgen with
the Regulatory Authorities having jurisdiction in the Territory regarding the
manufacture of any Collaboration Product by Amgen for supply to Hyseq; provided
however, that Amgen's obligation to provide Hyseq with Amgen Material and
Manufacturing Information is limited to the circumstance where the information
is reasonably required for Hyseq to carry out its responsibilities as
Development Lead and/or Regulatory Lead and/or Commercial Lead, or is required
by law, rule, regulation or a Regulatory Authority having
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jurisdiction in the Territory, to have access; but Hyseq shall only be entitled
to use such information to the extent required by such law, rule, regulation or
Regulatory Authority or to the extent reasonably required to carry out its
responsibilities as Development, Regulatory and/or Commercial Lead. For so long
as Amgen is supplying Hyseq with Collaboration Products hereunder, Amgen shall
have the right to be present at all meetings and to participate in telephone
calls with Regulatory Authorities having jurisdiction in the Territory wherein
the CMC contained in any Regulatory Filing is to be discussed.
(c) After the Transition Date for a Collaboration Product in an
indication, and with respect to such indication, the Commercial Lead (as the
Regulatory Lead) shall have exclusive responsibility for all correspondence and
for any official communications (except as the other Party may be required by
applicable laws or regulations or a Regulatory Authority to communicate) with
Regulatory Authorities in the Territory (e.g., annual reports, filing of
Promotional Materials) consistent with all applicable laws and regulations
(including the FD&C Act and the PHS Act, and any amendments thereto and the
regulations promulgated thereunder) and the equivalent regulations of any
country in the Territory. The other Party shall have the right to be present
(and to participate at the request of the Commercial Lead or the Regulatory
Authority) at all face-to-face meetings and scheduled conference calls regarding
significant clinical events or decisions. Except as may be required by
applicable laws and regulations, or requested by the Commercial Lead or any
Regulatory Authority having jurisdiction in the Territory, the other Party shall
not communicate regarding any Collaboration Product with any Regulatory
Authority having jurisdiction in the Territory. The other Party shall keep the
Commercial Lead informed of any such required communications. The other Party
shall provide the Commercial Lead with all information regarding ongoing
activities (in clinical trials, etc.) that the Commercial Lead needs to fulfill
the reporting requirements to Regulatory Authorities for the Collaboration
Products.
(d) Each Party shall promptly notify the other Party of and provide such
other Party with a copy of any correspondence or other reports or complaints
submitted to or received from any Regulatory Authority, or other Third Party
claiming that any Promotional Materials are inconsistent with the Product
Labeling or are otherwise in violation of any applicable laws and regulations
(including the FD&C Act, the PHS Act, and any amendments thereto and the
regulations promulgated thereunder) and the equivalent regulations in the
Territory.
4.8 APPLICATIONS FOR REGULATORY EXCLUSIVITY. The Parties recognize that
exclusivity rights granted or provided for under regulatory laws of the
countries of the Territory may be commercially significant to Collaboration
Products. To the extent permitted by law, as between the Parties, the Commercial
Lead shall have the exclusive right to file for, request and maintain any
regulatory exclusivity rights for Collaboration Products in the Territory
(including without limitation regulatory exclusivity rights based upon an orphan
drug designation of a Collaboration Product) and to conduct and prosecute any
proceedings or actions to enforce such regulatory exclusivity rights.
4.9 RECALLS.
10.
(a) The Parties shall exchange their internal standard operating
procedures, if any, as to product recalls ("SOPs") reasonably promptly after the
Effective Date and thereafter reasonably promptly after such SOPs are approved
or modified. If either Party becomes aware of information about quantities of
Collaboration Product supplied by the Manufacturing Lead to the other Party
which may not conform to the specifications for such Collaboration Product then
in effect pursuant to the Program Plan, or for which there are potential
adulteration, misbranding and/or other issues regarding safety or effectiveness,
or for which the Collaboration Product itself is alleged or proven to be the
subject of a Recall in any country in the Territory, it shall promptly so notify
the other Party and the Party having the right to control such a Recall pursuant
to Section 4.9(b) below may take [***] with notice to the Steering Committee
when the regulatory timeframes or public safety considerations so require. In
all other circumstances Recalls can only be made by [***] consent of the
Steering Committee and shall be made by the Party having the first right to
control a Recall pursuant to Section 4.9(b), below. The Steering Committee will
meet (in person, by telephone or otherwise) to discuss such other circumstances
and to consider appropriate courses of action, which courses of action with
respect to a Recall shall be consistent with the internal SOP of the Party
having the first right to control such Recall pursuant to Section 4.9(b) below,
and the other Party shall make available to the Party having the first right to
control such Recall all pertinent records which the Party having the first right
to control such Recall may reasonably request to assist in effecting any Recall.
(b) With respect to any clinical studies conducted by Hyseq under this
Agreement, Hyseq shall have the first right to control a Recall of the
Collaboration Product in the Territory. If Hyseq shall elect not to conduct a
Recall of the Collaboration Product in the Territory when, in the good faith
opinion of Amgen, regulatory timeframes or public safety considerations so
require, Amgen shall have the right to conduct such Recall. Other than with
respect to any clinical studies conducted by Hyseq under this Agreement, the
Commercial Lead shall have the first right to control any Recall of the
Collaboration Product in the Territory. If the Commercial Lead shall elect not
to conduct a Recall of the Collaboration Product in the Territory when, in the
good faith opinion of the other Party, regulatory timeframes or public safety
considerations so require, the other Party shall have the right to conduct such
Recall. Hyseq and Amgen shall each maintain complete and accurate records of any
Recall it has the right to control pursuant to this Section 4.9 for such periods
as may be required by legal requirements, but in any event for no less than
[***].
4.10 MANUFACTURING. The Manufacturing Lead shall cooperate with the
Regulatory Lead for a Collaboration Product in an indication with respect to
Regulatory Authority reporting, other communications and Regulatory Filings
regarding such Collaboration Product in such indication and the Manufacturing
Lead shall bear initial responsibility for preparing communications relating to
manufacturing issues, subject to review by the other Party. In order to help
preserve the proprietary nature of Amgen's manufacturing information (e.g., the
CMC section contained in any Regulatory Filings), Amgen shall have the right, to
the extent permitted by Regulatory Authorities, to file a drug master file with
a Regulatory Authority to make the information regarding such manufacturing
information available directly to the Regulatory Authority; provided however,
that Hyseq (as Development Lead, Regulatory Lead and/or Commercial Lead) shall
have the right to access and reference the Regulatory Filing, including
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the CMC section and documentation, to the extent required by law, rule,
regulation or a Regulatory Authority having jurisdiction in the Territory or
which Hyseq reasonably requires in order to carry out its responsibilities as
Development Lead and/or Regulatory Lead and/or Commercial Lead. Hyseq shall only
be entitled to use such information to the extent reasonably required by such
law, rule, regulation or Regulatory Authority or to carry out its
responsibilities as Development, Regulatory and/or Commercial Lead.
ARTICLE 5
COMMERCIALIZATION
5.1 IDENTIFICATION OF COMMERCIAL LEAD AND CO-DETAILER. Unless Amgen
elects to exercise its option right to convert its Commercial Lead right to a
Co-Detailer right pursuant to Section 5.8, reference herein to "Commercial Lead"
shall mean Amgen and reference to "Co-Detailer" shall mean Hyseq. If Amgen
exercises its option pursuant to Section 5.8, reference to "Commercial Lead"
shall mean Hyseq and reference to "Co-Detailer" shall mean Amgen.
5.2 RESPONSIBILITIES AND RIGHTS OF THE COMMERCIAL LEAD. The Commercial
Lead shall be responsible for preparing and submitting the Commercial Plan
section of the Program Plan to the Steering Committee (within [***] after the
filing of a first BLA for a first Collaboration Product for an indication) for
its approval, as well as updating the Commercial Plan [***]; provided however,
it is acknowledged and agreed that the Commercial Plan may need to be modified
from time-to-time, [***], upon the occurrence of unanticipated events. [***].
The Commercial Lead shall have responsibility for all aspects of Commercializing
Collaboration Product(s) in the Territory, including making all strategic and
tactical decisions with respect thereto in accordance with the Commercial Plan
and establishing the methods and means by which it performs such services
(including the management of permitted subcontractors, pursuant to Section
18.7). Each Party shall be responsible for carrying out its assigned activities
in accordance with the Commercial Plan. These activities shall include, without
limitation: (a) Commercial strategies (e.g., strategies for regulatory,
branding, product positioning, pre-launch (e.g., market research), launch and
post-launch marketing and promotion, pricing and reimbursement and field sales
force optimization); (b) packaging, labeling and language to be included in the
package insert; (c) forecasting sales and Commercial manufacturing production
requirements; (d) creating and developing Promotional Materials regarding
Collaboration Products which are intended for distribution to Third Parties
(including medical professionals) and to the Parties' respective sales forces;
(e) Promotion; (f) Detailing (subject to the Co-Detailer's limited right as set
forth in Section 5.3), including setting sales force staffing levels and
Detailing levels (including the relative proportion of required primary
Details); (g) sales and distribution including booking sales (i.e., recognizing
all revenues), taking orders and distributing, contracting, handling of returns,
handling all aspects of order processing, invoicing and collecting, warehousing,
documenting inventory and receivables and collecting prescription tracking, call
reporting, handling data regarding sales to hospitals and other end users (e.g.,
DDD data) and handling all other customer service-related functions); (h) level
of sampling; (i) selecting, obtaining and maintaining generic names and Product
Trademarks; (j) licensing or otherwise acquiring rights to intellectual property
from Third Parties (but excluding anything covered by Section 6.8); (k)
preparing and filing Drug Approval Applications for all
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clinical studies; (l) supervising and training of (and coordinating sales
briefing meetings and disseminating information, including all communications
related to marketing and Promotion) and otherwise aligning sales force
operations by and between sales representatives of both Parties as may be
required to Detail Collaboration Products as provided herein; (m) establishing
target call lists; (n) carrying out all aspects of (e.g., designing studies and
protocols) conducting, and preparing the associated Regulatory Plan for all
Post-Approval Clinical Studies; (o) preparing publications and presentations of
data regarding Collaboration Products generated upon or after the Transition
Date of the first Collaboration Product and (p) establishing collaboration and
material transfer agreements, pursuant to Section 9.13, upon or after the
Transition Date of the first Collaboration Product.
5.3 LIMITED CO-DETAILING RIGHTS OF CO-DETAILER.
(a) At its request, the Co-Detailer shall have a limited secondary
right, but not the obligation, to deploy a supportive sales force in the United
States to co-Detail Collaboration Products, [***]. For the avoidance of doubt,
in the event the Co-Detailer elects not to deploy a supportive sales force, the
Co-Detailer shall retain its designation as "Co-Detailer" hereunder and its
rights and obligations will not otherwise be limited or restricted (including
the rights of a "Co-Detailer" under this Agreement); provided however that if
the Co-Detailer later elects to deploy a supportive sales force the Commercial
Lead shall transition activities to the Co-Detailer in an orderly manner that
will not adversely affect product sales or profitability of the Collaboration
Products. All such co-Detailing efforts by the Co-Detailer shall be under the
coordination, direction and approval of the Commercial Lead (after consultation
with the Co-Detailer). Such coordination, direction and approval shall include,
without limitation, the following terms and conditions.
(i) The Co-Detailer's sales force shall only Detail a
Collaboration Product in the United States.
(ii) The Co-Detailer's sales force shall be [***] (e.g., whether
or not such supportive sales force representatives shall double call on
customers already called on by sales force representatives of the
Commercial Lead), provided however, that notwithstanding the above, the
supportive sales force representatives shall not call on national
accounts.
(iii) The Co-Detailer's sales force shall jointly Detail with
the sales force of the Commercial Lead under a single Product Trademark
in accordance with the Commercial Plan including, without limitation,
being trained by and using the field sales force materials (including,
without limitation, Promotional Materials) and systems of the Commercial
Lead.
(iv) The Co-Detailer's sales force shall only Detail a
Collaboration Product [***].
(v) The number of representatives within the Co-Detailer's sales
force shall be determined as follows:
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(1) in any succeeding Calendar Year following a Calendar Year in
which the U.S. annual Net Sales of Collaboration Products shall have
been below or equal to [***], the number of representatives within the
Co-Detailer's sales force for any such succeeding Calendar Year shall be
approximately [***] of the estimated total number of representatives
within the combined field sales force of both Parties, as set forth in
such Commercial Plan; and
(2) in any succeeding Calendar Year following a Calendar Year in
which the U.S. annual Net Sales of Collaboration Products shall have
been above [***], the number of representatives within the Co-Detailer's
sales force for any such succeeding Calendar Year shall be approximately
[***] of the estimated total number of representatives within the
combined field sales force of both Parties, as set forth in such
Commercial Plan.
(b) The Commercial Lead shall determine the minimum level of effort and
resources the Co-Detailer shall be directed to commit to individual field
activities under Section 5.3(a), provided the overall effort and resources of
the Co-Detailer shall be generally proportional to the relative percentage of
sales representatives deployed in the United States by the Co-Detailer under
Section 5.3(a)(v).
(c) Except with the prior written consent of the Commercial Lead, all
sales representatives of the Co-Detailer Detailing a Collaboration Product shall
be full-time employees of the Co-Detailer. If the Commercial Lead, in good
faith, shall determine that any sales representative of the Co-Detailer does not
meet the professional standards established by the Commercial Lead for its own
sales representatives or is not competent or qualified to carry out the
Co-Detailer's responsibilities pursuant to this Section 5.3, the Commercial Lead
(at its discretion after consultation with the Co-Detailer) may require the
Co-Detailer to [***] from the Detailing of all Collaboration Products.
(d) If a Collaboration Product is returned to the Co-Detailer, it shall
promptly be shipped to the facility responsible for shipment of Collaboration
Products in the country in question, to the attention of a department or to
another location as may be designated by the Commercial Lead.
(e) Neither Party shall have any responsibility for the hiring, firing
or compensation of the other Party's employees or for any employee benefits. No
employee or representative of a Party shall have any authority to bind or
obligate the other Party to this Agreement for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability on the
other Party without said other Party's authorized written approval.
5.4 MEDICAL AND OTHER INQUIRIES. The Commercial Lead shall have
responsibility for all correspondence and communication with physicians and
other health care professionals and customers in the Territory regarding product
complaints (e.g., quality) and all adverse drug experience information and,
other than with respect to the Co-Detailer's rights in Section 5.3, all other
correspondence and communication with physicians and other health care
professionals and customers in the Territory. The Commercial Lead shall keep
such records and make such
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reports as shall be reasonably necessary to document such communications in
compliance with all applicable regulatory requirements.
5.5 PROMOTIONAL MATERIALS. The Commercial Lead shall be responsible for
the creation, preparation, production and reproduction of all Promotional
Materials and for filing, as appropriate, such Promotional Materials with all
Regulatory Authorities.
(a) Upon the other Party's request and to the extent permitted by law,
regulation or Regulatory Authorities, the other Party's corporate name and/or
logo shall be included on Promotional Materials and Product Labeling in
positions of equivalent prominence and frequency with the corporate name and
logo of the Commercial Lead.
(b) In order to maintain the value of the other Party's corporate name
and/or logo, when using the other Party's corporate name and/or logo, the
Commercial Lead shall maintain such reasonable quality standards as it maintains
for its own corporate name and/or logo and shall comply with the other Party's
then-current policies regarding use of its corporate name and/or logo. Prior to
the use thereof, the Commercial Lead shall provide to the other Party a
prototype of any Promotional Materials or Product Labeling which contains the
other Party's corporate name and/or logo, so that the other Party may review the
manner in which its corporate name and/or logo are used therein. The other Party
shall notify the Commercial Lead within ten (10) days after delivery of such
prototype, whether the other Party approves or disapproves of the manner of such
use and, in the case of disapproval, the specific reasons therefor and an
acceptable alternative. In the event the other Party fails to so notify the
Commercial Lead within such 10-day period, the other Party shall be deemed to
have approved the manner of such use. In the event that (i) the Promotional
Materials and Product Labeling comply with Section 5.5(a), but the other Party
disapproves of the manner of such use and (ii) the Parties are unable to reach
agreement regarding the manner of such use before an applicable regulatory or
other legal deadline for submission of Promotional Materials, then the
Commercial Lead shall retain the right to print and use, and the other Party
agrees to use, to the extent applicable, such Promotional Materials and Product
Labeling without the other Party's corporate name and/or logo. The Commercial
Lead and other Party shall continue efforts to reach agreement on approving
Promotional Materials with the other Party's corporate name and/or logo that
comply with Section 5.5(a).
5.6 COMPLIANCE WITH LAWS, REGULATIONS AND GUIDELINES. Each Party agrees
to comply with all applicable laws, rules and regulations (e.g., the FD&C Act,
the PHS Act, the U.S. Foreign Corrupt Practices Act and any amendments thereto
and the regulations promulgated thereunder, and the equivalent laws, rules and
regulations in the Territory) and in all material respects to conform its
practices and procedures with, as applicable, the Pharmaceutical Research and
Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing Practices
and the American Medical Association ("AMA") Guidelines on Gifts to Physicians
from Industry, as the same may be amended from time to time, and equivalent
guidelines in the Territory with respect to the Commercialization of
Collaboration Products. Each Party shall conduct its business operations and
cause each of its employees, representatives and agents to do nothing which such
Party knows or reasonably should know would jeopardize the good will or
reputation of the other
15.
Party or the Collaboration Products. Neither Party shall be required to
undertake any activity relating to the Commercialization of Collaboration
Products that it believes, in good faith, may violate any law or regulations.
Each Party shall promptly notify the other Party of and provide to that other
Party a copy of any correspondence or other reports with respect to the
Promoting or Detailing of Collaboration Products submitted to or received from
PhRMA or the AMA or equivalent organizations in the Territory and the Commercial
Lead shall be responsible for responding to such correspondence or other
reports. Each Party shall in all material respects conform its practices and
procedures relating to educating the medical community in the U.S. with respect
to Collaboration Products to the Accreditation Council for Continuing Medical
Education ("ACCME") Standards for Commercial Support of Continuing Medical
Education and any applicable FDA regulations or guidelines, as the same may be
amended from time to time, and, as applicable, equivalent guidelines in the
Territory and each Party shall promptly notify the other Party of and provide to
the other Party a copy of any correspondence or other reports submitted to or
received from the ACCME with respect to Collaboration Products and the
Commercial Lead shall be responsible for responding to such correspondence or
other reports.
5.7 REPORTS.
(a) For information purposes each Party shall provide the other Party
with current Detailing reports of the number of Details delivered, broken down
by sales force and by physician specialty. Such Detailing reports and any other
relevant sales force information related to such Collaboration Product shall be
provided to the other Party on a mutually agreed regular basis (e.g., monthly).
(b) No later than [***] after the conclusion of each Calendar Quarter
after First Commercial Sale of a Collaboration Product in a country in the
Territory, each Party shall submit to the other Party an audit report, based
upon the reporting Party's internal Detailing report data, setting forth the
number of the reporting Party's Details for such Collaboration Product for the
Calendar Quarter for each such country in the Territory, broken down by sales
force and by physician specialty. Each Party agrees to make available to the
other Party, upon reasonable advance notice, such books and records necessary to
verify the accuracy of such audit report in respect of any Calendar Quarter
ending not more than [***] prior to the date of such request. Upon expiration of
[***] following the end of any Calendar Year, the audit report reflecting the
reporting Party's Details for such Collaboration Product for such Calendar Year
shall be binding on the other Party, and the reporting Party shall be released
from any liability or accountability to the other Party with respect to the
number of Details given during such Calendar Year unless prior to such
expiration the other Party has notified the reporting Party of an issue
regarding such audit report (arising from such inspection) pursuant to Section
5.7(c), below.
(c) Except as set forth in this Section 5.7 and subject to the other
Party's rights under Section 5.7(b), for purposes of this Agreement the number
of Details for a Collaboration Product performed by a Party for a given Calendar
Quarter shall be based on such performing Party's internal Detailing report
data.
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(i) If the other Party has a good faith concern with the
accuracy of the number of the performing Party's Details reflected by
the performing Party's internal Detailing report data (based on the
other Party's assessment of such data when compared to available Third
Party audit data, sampling data, if applicable, or other relevant data
relating to the performing Party's Detailing of such Collaboration
Product), then the other Party shall so advise the performing Party of
such concern, and promptly thereafter the other Party's and the
performing Party's representatives shall consider in good faith whether
the number of Details reflected by the performing Party's internal
Detailing report data are accurate and, if not, whether an adjustment to
the number of Details of such Collaboration Product performed by the
performing Party for such Calendar Quarter is appropriate.
(ii) If such representatives referred to in Section 5.7(c)(i)
are unable to resolve the matter, either Party may, by notice to the
other Party, have the dispute [***], or their designees, for attempted
resolution by good faith negotiations for a period of not more than
[***] after such notice is received or such other period of time as may
be mutually agreed upon by the Parties to determine whether an
adjustment to the number of the performing Party's Details for
Collaboration Product in such Calendar Quarter is appropriate.
(iii) If the Parties are unable to resolve the matter after such
negotiation as provided in Section 5.7(c)(ii), then such dispute
regarding the number of the performing Party's Details for Collaboration
Product in such Calendar Quarter shall [***]. The fees that such market
research firm or other expert shall be paid in connection with such
resolution shall be charged to the Operating Profit or Loss account. The
settlement of such dispute [***] shall be binding upon the Parties, and
[***]. The Parties expressly recognize that Third Party audits of
Details conducted hereunder do not accurately reflect actual Details
conducted hereunder and that, for purposes of determining any potential
shortfall in Details conducted hereunder, if the ratio of Third Party
audits of Details conducted hereunder to the performing Party's internal
Detail reports is within the range then existing for other comparably
promoted products by the performing Party, then the performing Party's
internal Details report shall be deemed to be accurate by the Parties.
5.8 AMGEN'S CO-DETAILER OPTION.
(a) Subject to the terms of this Section 5.8(a), Amgen shall have the
option to convert its right to be the Commercial Lead to the right to be the
Co-Detailer with respect to a Collaboration Product. Amgen may exercise such
option with respect to a Collaboration Product: (i) at any time between the
Effective Date and [***] after commencing a Pivotal Trial of such Collaboration
Product or (ii) at any time after [***] of the date of [***] of such
Collaboration Product. If Amgen wishes to exercise such Co-Detailer option at
the times permitted hereunder, it shall give Hyseq written notice.
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(b) If Hyseq becomes the Commercial Lead of a Collaboration Product
under the terms and conditions of this Agreement, Amgen: (i) shall immediately
and, for a period of [***] after Hyseq's acceptance, provide reasonable
assistance (including providing reasonable access to and assistance from those
of Amgen's Collaboration Product marketing personnel selected by Amgen) to
transition such marketing and sales force training knowledge and materials to
Hyseq to enable it to assume the responsibilities of Commercial Lead pursuant to
Section 5.2, provided however, that Amgen shall retain its rights and
obligations of Commercialization during such [***] transition period; and (ii)
shall assign Amgen's entire right, title and interest in and to all Drug
Approval Applications and, to the extent applicable, Regulatory Approvals for
Collaboration Products in the Territory to Hyseq and, within such [***] period
shall notify Regulatory Authorities in the Territory of (and as soon as is
reasonably practicable thereafter, take all actions reasonably necessary to
effect or evidence) the transfer of such Drug Approval Applications and
Regulatory Approvals to Hyseq; provided however, that Amgen's obligation to
provide Hyseq with Amgen Material and Manufacturing Information is limited to
circumstances where Hyseq is required by law, rule, regulation or a Regulatory
Authority having jurisdiction in the Territory or to the extent reasonably
required to have access in order to carry out its responsibilities as Regulatory
Lead and/or Commercial Lead. Hyseq shall only be entitled to use such
information to the extent required by such law, rule, regulation or Regulatory
Authority or to the extent reasonably required to carry out its responsibilities
as Development, Regulatory and/or Commercial Lead. After such [***] period Hyseq
shall be the designated Commercial Lead and shall assume all rights and
obligations associated therewith as set forth in this Article 5, Amgen shall be
the Co-Detailer and shall assume all rights and obligations associated therewith
as set forth in this Article 5, and Hyseq shall be designated the Regulatory
Lead for the indications for which Amgen (as the Commercial Lead) had been the
Regulatory Lead and Hyseq shall assume all rights and obligations associated
therewith as set forth in Article 4.
ARTICLE 6
MANUFACTURE AND SUPPLY
6.1 MANUFACTURING LEAD. Reference to "Manufacturing Lead" shall mean
Amgen, unless Amgen elects to exercise its right pursuant to Section 6.7 below.
If Hyseq or a Third Party shall manufacture Collaboration Products then the
Manufacturing Lead shall be Hyseq.
6.2 RESPONSIBILITIES AND RIGHTS OF MANUFACTURING LEAD. The Manufacturing
Lead shall be responsible for preparing and submitting the Process
Development/Manufacturing Plan section of the Program Plan to the Steering
Committee (within [***] after receiving annual forecasts from the Development
Lead and/or Commercial Lead, as applicable) for its approval, as well as
updating the Process Development/Manufacturing Plan [***]; provided however, it
is acknowledged and agreed that the Process Development/Manufacturing Plan may
need to be modified from time-to-time, between annual updates, upon the
occurrence of unanticipated events. The Manufacturing Lead shall have the first
right to manufacture and supply Collaboration Products for Development and
Commercialization in the Territory, in accordance with the Process
Development/Manufacturing Plan. The Process Development/Manufacturing Plan shall
set forth the activities necessary or useful to obtain the authorization to
manufacture,
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formulate, fill and ship Collaboration Products in the Territory including,
without limitation, bulk manufacture, finish and fill, labeling and packaging,
lot release and process development work to support quality assurance, improving
manufacturing/cost efficiency and commercial scale-up manufacturing. [***]. The
Manufacturing Lead shall have responsibility for all aspects of manufacturing
Collaboration Products(s) in the Territory (excluding product specifications and
product forecasts), including making all strategic and tactical decisions with
respect thereto in accordance with the Process Development/Manufacturing Plan,
establishing the methods and means by which it performs such services and
fulfilling its regulatory responsibilities over all steps of the manufacturing
process (including the management of permitted subcontractors, pursuant to
Section 18.7).
6.3 MANUFACTURE OF COLLABORATION PRODUCTS FOR DEVELOPMENT. With respect
to each Collaboration Product selected to be advanced to IND-enabling toxicology
studies and/or clinical studies, prior to the first Transition Date with respect
to such Collaboration Product the Manufacturing Lead shall use Commercially
Reasonable Efforts to develop and initiate scale-up of the manufacturing
process, to develop a manufacturing process(es) suitable for commercial
production, and to supply (in accordance with Section 6.5) clinical grade,
filled and finished, selected Collaboration Products and placebo for use in all
pre-clinical trials and clinical trials in the Territory, in quantities (as
reasonably forecast by Hyseq) and with specifications (to the extent consistent
with Section 6.5) as set forth in the Process Development/Manufacturing Plan
section of the Program Plan. The Development Lead shall determine its good faith
projected Collaboration Product supply needs, taking into consideration
inventory levels, and will deliver an annual forecast, updated quarterly.
6.4 MANUFACTURE OF COLLABORATION PRODUCT(S) FOR COMMERCIALIZATION. With
respect to each Collaboration Product, after the first Transition Date of each
such Collaboration Product the Manufacturing Lead shall use Commercially
Reasonable Efforts to supply (in accordance with Section 6.5) filled and
finished Collaboration Products approved by each applicable Regulatory Authority
for commercial use in the Territory, in quantities (as reasonably forecast by
the Commercial Lead) and with specifications (to the extent consistent with
Section 6.5) as set forth in the Process Development/Manufacturing Plan section
of the Program Plan for such approved Collaboration Product. The Commercial Lead
shall determine its good faith projected Collaboration Product supply needs,
taking into consideration inventory levels, and will deliver an annual rolling
forecast, updated quarterly.
6.5 STANDARDS OF SUPPLY. Collaboration Products shall be manufactured by
the Manufacturing Lead (pursuant to Section 6.3 and 6.4) in accordance with
current GMP in a manufacturing process and facility as described in the
applicable Regulatory Filings filed with the Regulatory Authority. The
Manufacturing Lead shall be responsible for the labeling, packaging and lot
release of such Collaboration Products. The Manufacturing Lead shall be
responsible for the quality assurance/quality control (QA/QC) of all
manufactured Collaboration Products and shall provide a certification that all
supplied Collaboration Products shall conform to the product specifications.
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6.6 STANDARD COST AND BUDGET. The Manufacturing Lead shall have the
right to charge to the Operating Profit or Loss account the cost of developing
manufacturing processes, manufacturing and supplying Collaboration Products in
accordance with Sections 6.3 and 6.4, at the Manufacturing Lead's Standard Cost
plus [***]. Standard Cost for a Calendar Year shall be estimated or established
on a reasonable basis by the Manufacturing Lead. Within [***] following the end
of the Manufacturing Lead's fiscal year, the Manufacturing Lead shall calculate
an annual adjustment by comparing its actual annual manufacturing costs
(including [***], if any) to total costs calculated using the [***] amount
(vials manufactured multiplied by Standard Cost per vial, excluding any annual
adjustment related to the previous year, but including any interim adjustment
charged to the Commercial Lead as described below). The Manufacturing Lead shall
use this annual adjustment to increase/decrease the Standard Cost for the
then-current Calendar Year in order to recover/refund this difference from/to
the Parties. The per unit annual adjustment to the Standard Cost shall be based
upon the forecasted annual requirements (as included in the rolling forecast to
be supplied by the Development Lead and/or Commercial Lead on a quarterly basis)
for such following year. Until the annual adjustment is calculated, the
Manufacturing Lead shall estimate the annual adjustment to be included in the
following year's Standard Cost in good faith. In addition, if the rolling
forecast volume over the next [***] to be supplied to the Development Lead
and/or Commercial Lead decreases by more than [***] compared to the previously
submitted rolling forecast, [***] for the year will be recalculated. If, based
upon such recalculation, the Manufacturing Lead determines that [***] has
increased, an interim adjustment shall be made to [***] and such interim
adjustment will apply to all Collaboration Products and placebos supplied for
the remainder of the year. The Manufacturing Lead will give the other Party
[***] written notice prior to applying the [***] in Standard Cost. [***] per
year, the other Party shall have the right, at its own cost, to cause its
independent certified public accountant to audit the Manufacturing Lead's books
and records, upon reasonable notice and during normal business hours, to
determine the accuracy of such Standard Cost calculation and any adjustments
thereto. In the event the manufacturing rights are transferred to a Third Party
manufacturer as per Section 6.7, the actual cost of purchasing the Collaboration
Product will be charged to the Operating Profit or Loss account in lieu of
charging the Manufacturing Lead's Standard Cost plus [***], as outlined above.
6.7 ALTERNATIVE MANUFACTURING SOURCE. In the event Amgen, at any time
and in its sole discretion, decides not to manufacture Collaboration Products
and not to act as the Manufacturing Lead as set forth in Section 6.3 or 6.4,
then Amgen shall provide written notice thereof to Hyseq. Within [***] after
receipt of such notice together with access to such Amgen Material and
Manufacturing Information reasonably necessary to make a decision on
manufacturing, Hyseq shall notify Amgen whether Hyseq shall manufacture
Collaboration Products itself or, if Hyseq does not elect to so manufacture, the
name of a proposed Third Party manufacturer for Amgen's approval, such approval
not to be unreasonably withheld; provided however, if Hyseq does not provide
such notice within such [***] period or if Amgen does not approve of a Third
Party manufacturer in such [***] period, Amgen [***] may, at any time
thereafter, [***] select a Third Party manufacturer which must have [***]
(within a reasonable period of time thereafter) to make Collaboration Products
in a suitable quality and [***], such selection to be [***] Hyseq. Once Amgen
has approved ([***]) a Third Party manufacturer, Hyseq, in consultation with
Amgen, shall be responsible for promptly negotiating the terms of
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the agreement pursuant to which such Third Party manufacturer will manufacture
and supply Collaboration Products, which agreement Amgen shall have the right to
approve, such approval not to be unreasonably withheld or delayed. For the
avoidance of doubt, Amgen may withhold the right of Hyseq or a designated Third
Party manufacturer to use Amgen Material and Manufacturing Information to
manufacture Collaboration Products unless and until Hyseq or such Third Party
manufacturer satisfies Amgen that all necessary Third Party intellectual
property licenses shall have been obtained; provided however that Amgen shall
not delay transfer of Amgen Material and Manufacturing Information to Hyseq or
such Third Party manufacturer during any time period that Hyseq or such Third
Party manufacturer is seeking to obtain any such Third Party intellectual
property licenses. The Parties acknowledge that Amgen has a license from [***]
for licensing of certain [***] technology. Amgen agrees to contact [***]
promptly after the Effective Date to request a right of sublicense to Hyseq of
Amgen's rights under such license with respect to Collaboration Products;
provided however, Hyseq shall have the right to approve of any such sublicense
and agrees that (i) any consideration required for such sublicense shall be paid
directly by Hyseq and not charged to the Operating Profit or Loss account and
(ii) nothing contained hereunder shall be construed as a representation that any
such sublicense will be available or as a commitment by Amgen that Hyseq may
obtain such sublicense as a result of Amgen's effort. Thereafter, Hyseq shall be
designated as the "Manufacturing Lead" (whether it manufactures Collaboration
Products itself or via an approved Third Party manufacturer) and shall assume
all rights and obligations therewith as set forth in this Article 6. Promptly
after receiving notice from Hyseq that it shall manufacture Collaboration
Products or after Amgen's approval of a Third Party manufacturer under this
Section 6.7, Amgen shall transfer to Hyseq (or an approved Third Party
manufacturer as designated in such notice) the Amgen Material and Manufacturing
Information and shall provide all associated technical assistance so as to
permit the transferee to implement the manufacturing process and shall grant to
such transferee a license under Amgen Technology to make (and in the case of
Hyseq, to make and have made) the Collaboration Products. All transfer of such
Information and Materials to Hyseq and associated assistance shall be charged as
Other Allowable Expenditures to the Operating Profit or Loss account. For the
avoidance of doubt, Amgen shall not be required to transfer any capital
equipment; provided however, capital equipment useful for the manufacture of
Collaboration Products will be transferred (with title and risk of loss passing
to Hyseq immediately after leaving Amgen's facility) to the extent Amgen elects
to offer such equipment to Hyseq and Hyseq agrees to accept and reimburse Amgen
for such equipment. For a period of up to [***] after Hyseq provides Amgen with
notice that Hyseq shall manufacture Collaboration Products or after Amgen's
approval of a Third Party manufacturer under this Section 6.7, Amgen will
continue to provide clinical and commercial manufacturing of then-manufactured
Collaboration Products (or will provide an equivalent supply to satisfy the
then-current forecasts). The transfer of Amgen Material and Manufacturing
Information and continued supply of Collaboration Products by Amgen pursuant to
this Section 6.7 shall be conducted in accordance with a transition plan which
shall be approved by [***] decision of the Steering Committee and which sets
forth responsibilities and schedules for transferring the Amgen Material and
Manufacturing Information as expeditiously as possible to meet the foregoing
[***] time limit with the goal of providing for an uninterrupted supply of
Collaboration Product of suitable quality and quantity required for the
Development and/or Commercialization to proceed. Once Amgen has transferred the
Amgen Materials and
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Manufacturing Information and otherwise fulfilled its obligations under this
Section 6.7, Amgen shall no longer be responsible for manufacturing
Collaboration Products under this Agreement.
6.8 THIRD PARTY LICENSES. [***] deems necessary for a license or other
rights or to incur an obligation for any Third Party payments for a license to
any Third Party of Patent Rights and other intellectual property rights
necessary or useful to make or have made a Collaboration Product in a country in
the Territory, for subsequent use, sale or other exploitation or transfer of
physical possession of or title in a Collaboration Product in the Territory. The
Manufacturing Lead shall have the right to incorporate Third Party payments made
to any Third Party within the Cost of Goods, as set forth in Schedule I.
ARTICLE 7
COLLABORATION CONSIDERATION
7.1 LICENSE FEE. In lieu of the payment of up-front cash consideration
and subject to the terms and conditions set forth below and in that certain
warrant agreement executed on the same date herewith ("Warrant Purchase
Agreement"), Hyseq shall issue to Amgen an irrevocable warrant to purchase one
million four hundred ninety-one thousand five hundred forty-four (1,491,544)
fully paid and nonassessable shares of Hyseq's Common Stock, par value $ 0.001
per share, all as more fully described in the Warrant Purchase Agreement. A copy
of the Warrant Purchase Agreement, in the form to be executed and delivered by
each of Amgen and Hyseq on the Effective Date, is attached hereto as Schedule
III.
7.2 REGULATORY APPROVAL MILESTONE. Hyseq shall pay to Amgen a one-time
milestone payment of Ten Million Dollars ($10,000,000.00) within thirty (30)
days after the first Regulatory Approval for a first Collaboration Product in a
first Major Market Country. Such Milestone Payment shall not be payable more
than once, no matter how many times achieved by one or more Collaboration
Product(s). Such Milestone Payments shall be nonrefundable and noncreditable
against any other fees or other payments due Amgen with respect to Collaboration
Products under this Agreement.
ARTICLE 8
PROGRAM PLAN; OPERATING PROFIT OR LOSS
8.1 PROGRAM PLAN.
(a) No later than [***] after the Effective Date, the Steering Committee
shall review and approve the Program Plan (and associated budget) to cover the
first twelve (12) months after the Effective Date. Any disputes with respect to
the Program Plan shall be handled in accordance with Section 2.4(b). Once
approved, the Parties will be authorized to undertake their respective
activities for such initial twelve (12) month period under the Program Plan and
to charge the Operating Profit or Loss account for approved Collaboration
Expenditures. Schedule II provides a format for the Program Plan budget, which
format the Steering Committee shall have the right to modify from time-to-time.
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(b) Within [***] of the Effective Date and thereafter no later than
[***] before each anniversary of such [***] date of the Effective Date, the
Steering Committee shall review and approve the Program Plan (and associated
budget) covering the following Calendar Year. The Steering Committee shall
determine the timing of the annual budget cycles to meet the business objectives
of both Parties (e.g., to coincide with each Party's fiscal year) and will alter
the schedule accordingly. Once approved, the Parties will be authorized to
undertake their respective activities for such Calendar Year under the Program
Plan and to charge the Operating Profit or Loss account for approved
Collaboration Expenditures.
(c) On a [***] basis the Steering Committee shall review the
Collaboration Expenditures actually incurred against the budget of the Program
Plan for such expenses in the applicable Calendar Year and consider for approval
any appropriate changes to such budget. In preparing the reports contemplated by
Sections 8.3- below, costs and expenses shall be submitted as part of
Collaboration Expenditures only to the extent made or incurred in conjunction
with an approved budget line item as approved and revised from time-to-time by
the Steering Committee. Any expenditure(s) not included in an approved Program
Plan and/or any acceptable cost overruns to the budget (as pre-determined by the
Steering Committee) shall need written approval by the Steering Committee prior
to being charged as Collaboration Expenditures to the Operating Profit or Loss
account. Any expenditures not otherwise approved by the Steering Committee shall
not be deemed Collaboration Expenditures and shall be completely assumed by the
Party assuming such expenditure. Any disputes regarding such expenditures shall
be handled in accordance with Section 2.4(b).
8.2 OPERATING PROFIT OR LOSS SHARING. Amgen and Hyseq shall each share
on a fifty:fifty (50:50) basis the Operating Profit or Loss for all
Collaboration Products, except as set forth below:
(a) As of the Effective Date, Hyseq shall be responsible for [***] of
all approved Collaboration Expenditures up to and including the first [***]
incurred after the Effective Date.
(b) The Parties shall share on a fifty:fifty (50:50) basis all
Collaboration Expenditures in excess of [***] incurred after the Effective Date.
8.3 ACCOUNTING AND REPORTING OF COLLABORATION PROFITS AND LOSSES.
(a) On a quarterly basis during the Term of this Agreement, the Parties
shall each submit to the other Party a written report (including supporting
documentation) setting forth in reasonable detail an accounting of any approved
Collaboration Expenditures that have been incurred. These expenses will be
submitted in a timely manner to maintain accurate accounting of Operating Profit
or Loss.
(b) Prior to the Transition Date of the first Collaboration Product,
Hyseq shall establish and maintain an accounting of the approved Collaboration
Expenditures in the Operating Profit or Loss account. The format of the
reporting shall be initially as proposed in Schedule II, which may be changed
from time-to-time by the Steering Committee to meet the business objectives of
both Parties (e.g., to coincide with each Party's fiscal year).
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(i) Prior to the Operating Profit or Loss account reaching or
equaling a cumulative amount of [***] in Collaboration Expenditures from
the Effective Date, Hyseq shall provide a [***] reporting of those
Collaboration Expenditures to the Parties setting forth in reasonable
detail (and including supporting documentation) an accounting of all
items credited or charged to the Operating Profit or Loss account.
(ii) After the Operating Profit or Loss account balance exceeds
a cumulative amount of [***] in Collaboration Expenditures from the
Effective Date, Hyseq shall provide a [***] reporting of those
Collaboration Expenditures to the Parties. Within [***] following the
end of each Calendar Quarter, Hyseq shall submit to Amgen a written
report (including supporting documentation) setting forth in reasonable
detail (and including supporting documentation) an accounting of all
items credited or charged to the Operating Profit or Loss account and
the calculation of any net amount owed by Hyseq to Amgen or by Amgen to
Hyseq, as the case may be, in order to ensure the appropriate
fifty-fifty (50:50) sharing of Operating Profit or Loss. The net amount
payable shall be paid by Amgen or Hyseq, as the case may be, within
[***] after receipt of such written report, without regard to any
dispute as to the amounts under this Section 8.3(b)(ii), but subject to
Section 18.17.
(c) After the Transition Date of the first Collaboration Product, the
Commercial Lead shall establish and maintain an accounting of the approved
Collaboration Expenditures in the Operating Profit or Loss account. The format
of the reporting shall be initially as proposed in Schedule II, which may be
changed from time-to-time by the Steering Committee to meet the business
objectives of both Parties (e.g.,, to coincide with each Party's fiscal year).
Within [***] following the end of each Calendar Quarter, the Commercial Lead
shall submit to the other Party a written report setting forth in reasonable
detail (and including supporting documentation) an accounting of all items
credited or charged to the Operating Profit or Loss account and the calculation
of any net amount owed by Hyseq to Amgen or by Amgen to Hyseq, as the case may
be, in order to ensure the appropriate fifty-fifty (50:50) sharing of Operating
Profit or Loss. The net amount payable shall be paid by Amgen or Hyseq, as the
case may be, within [***] after receipt of such written report, without regard
to any dispute as to the amounts under this Section 8.3(c), but subject to
Section 18.17.
(d) In the event of a dispute with respect to any amounts under Sections
8.3(b) or 8.3(c), the disputing Party shall provide written notice within [***]
after receipt of the written report in question, specifying such dispute and
explaining the basis of the dispute. The Parties shall promptly thereafter meet
and negotiate in good faith a resolution to such dispute. In the event that the
Parties are unable to resolve such dispute within [***] after notice by the
disputing Party, the matter shall be resolved in a manner consistent with the
procedures set forth in Article 17 and shall not be subject to either Party's
casting vote. Notwithstanding the above, such dispute resolution shall not
prejudice a Party's right to audit the records of the other Party in accordance
with Section 10.2.
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(e) Hyseq and Amgen shall work in good faith to realize the benefits of
the orphan drug credits pursuant to IRC Section 41 and Section 45C for the
activities or expenditures of either Party under this Agreement or any legal
entity formed pursuant to Section 13.3(d).
(f) Upon termination of this Agreement, the Parties shall immediately
(but in no event any later than [***] from such termination) conduct a final
accounting to reconcile, settle and close the Profit or Loss account; provided
however, that after such final accounting, with respect to surviving sections
that reference the charging or crediting of the Profit or Loss account (e.g.,
Section 14.3, Section 16.9(a)(i) as it applies to Section 9.7(c) and Section
16.9(b)(i) as it applies to Sections 9.6(d) and Section 9.7(c)), such charges or
credits shall be made directly between the Parties and shall proportionally
borne by the Parties in the same manner as if such Profit or Loss account was
still open].
ARTICLE 9
INTELLECTUAL PROPERTY
9.1 TECHNOLOGY OWNERSHIP. Ownership of inventions shall be determined in
accordance with the rules of inventorship under United States patent laws.
Subject to the licenses granted in Section 9.2(a) below, as between the Parties,
Amgen shall own all right, title and interest in and to Amgen Technology, and
any Confidential Information contained therein shall be considered the
Confidential Information of Amgen. Subject to the licenses granted in Section
9.2(b) below, as between the Parties, Hyseq shall own all right, title and
interest in and to Hyseq Technology, and any Confidential Information contained
therein shall be considered the Confidential Information of Hyseq. All right,
title and interest in and to Joint Know-How (which shall be considered the joint
Confidential Information of the Parties) and Joint Patent Rights shall be owned,
as between the Parties, jointly by Hyseq and Amgen. Other than with respect to
the rights and licenses granted under this Agreement to Joint Know-How, each
Party shall have the unrestricted, royalty-free, worldwide right to make, have
made, use, sell, lease, offer to sell or lease, import, export or otherwise
exploit, or transfer physical possession of or title in Joint Know-How, without
accounting. All right and interest in and to Product Trademarks shall be owned,
as between the Parties, jointly by Hyseq and Amgen, and any Confidential
Information related thereto shall be considered the joint Confidential
Information of the Parties; provided however, if for any reason the Parties are
prohibited by law, rule or regulation in any country from jointly owning Product
Trademarks (or if the mutually acceptable outside counsel retained pursuant to
Section 9.4(d) so advises) the Commercial Lead shall own all such Product
Trademarks.
9.2 PATENT LICENSES.
(a) Amgen hereby grants to Hyseq a sole royalty-free license
(co-exclusive with only Amgen), with a qualified right to sublicense pursuant to
this Section 9.2(a), under the Amgen Technology to use, sell, offer to sell,
import, export or otherwise transfer physical possession of or otherwise
transfer title in Collaboration Products in the Field of Use in the Territory,
solely in compliance with the terms and conditions of this Agreement. For the
avoidance of doubt, as
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used in this Agreement a "sole" license which is "co-exclusive" with only the
licensor means that only the licensor and the licensee shall enjoy the rights to
the technology so licensed, to the exclusion of all others. Pursuant to Sections
18.6 and 18.7 below, Hyseq may grant sublicenses (or covenants not to ▇▇▇) under
Hyseq Technology, Joint Know-How, Joint Patent Rights and, to the extent
licensed under this Section 9.2(a), Amgen Technology.
(b) Hyseq hereby grants to Amgen a sole royalty-free license
(co-exclusive with only Hyseq), with a qualified right to sublicense pursuant to
this Section 9.2(b), under the Hyseq Technology to make, have made, use, sell,
offer to sell, import, export or otherwise transfer physical possession of or
otherwise transfer title in Collaboration Products in the Field of Use in the
Territory, solely in compliance with the terms and conditions of this Agreement.
Pursuant to Sections 18.6 and 18.7 below, Amgen may grant sublicenses (or
covenants not to ▇▇▇) under Amgen Technology, Joint Know-How, Joint Patent
Rights and, to the extent licensed under this Section 9.2(b), Hyseq Technology.
(c) Pursuant to Section 6.7 and subject to this Section 9.2(c) and
Section 9.2(e) below, Amgen shall grant to Hyseq an exclusive license (with a
limited sublicense right to Third Party manufacturers approved by Amgen) under
Amgen Technology and Amgen Material and Manufacturing Information to make, have
made and use Collaboration Products solely in compliance with the terms and
conditions of this Agreement. Amgen expressly reserves for itself and its
Affiliates a non-transferable, non-sublicensable license under the Amgen
Technology and the Amgen Material and Manufacturing Information to make and use
(but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer
title to or interest in) Collaboration Products for its (and its Affiliates')
own internal non-commercial purposes only. Amgen shall further retain all rights
in Amgen Technology and Amgen Material and Information not expressly licensed
hereunder (e.g., to make, have made, use, sell, offer to sell, import, export or
otherwise transfer physical possession of or otherwise transfer title in
products, other than Collaboration Products, in the Field of Use in the
Territory).
(d) Other than as expressly set forth in this Section 9.2, neither Party
shall grant any sublicense without the prior written consent of the other Party.
(e) Certain license rights granted to a Party under this Section 9.2 may
include a sublicense of Patent Rights and know-how of Third Parties under Third
Party licenses. Notwithstanding anything to the contrary in this Agreement, the
Party receiving a sublicense of such Third Party licenses shall, in exercising
such sublicense rights, comply with, perform in accordance with, and be subject
to the provisions of such Third Party licenses relating to Collaboration
Products if the granting Party has provided a copy of such Third Party license
to the Party receiving a sublicense of such Third Party licenses. Each Party
shall promptly provide to the other Party a copy of any notice of breach
received by it under any such Third Party license.
9.3 TRADEMARK; COPYRIGHT LICENSES.
(a) Amgen hereby grants to Hyseq a sole royalty-free license
(co-exclusive with only Amgen), without the right to grant sublicenses (except
as set forth in Sections 18.6 and 18.7), under Amgen Trademarks and Amgen's
entire right, title and interest in and to Product
26.
Trademarks to use and display the Amgen Trademarks and Product Trademarks in
connection with Collaboration Products in the Territory solely in compliance
with the terms and conditions of this Agreement (including Section 5.5);
provided however, that Hyseq agrees to comply with Amgen's then-current
trademark policy. Amgen shall have the right to audit and inspect, upon advance
written notice and during regular business hours, Hyseq's use of Trademarks
licensed hereunder.
(b) Hyseq hereby grants to Amgen a sole royalty-free license
(co-exclusive with only Hyseq), without the right to grant sublicenses (except
as set forth in Sections 18.6 and 18.7), under Hyseq Trademarks and Hyseq's
entire right, title and interest in and to Product Trademarks to use and display
the Hyseq Trademarks and Product Trademarks in connection with Collaboration
Products in the Territory solely in compliance with the terms and conditions of
this Agreement (including Section 5.5); provided however, that Amgen agrees to
comply with Hyseq's then-current trademark policy. Hyseq shall have the right to
audit and inspect, upon advance written notice and during regular business
hours, Amgen's use of Trademarks licensed hereunder.
(c) Each Party hereby grants to the other Party a sole license
(co-exclusive with only the other Party) under the Party's entire right, title
and interest in any copyrights in Promotional Materials, without the right to
grant sublicenses (except as set forth in Sections 18.6 and 18.7), to reproduce,
distribute copies of, prepare derivative works of and publicly perform and
display such Promotional Materials in connection with Collaboration Products in
the Territory solely in compliance with the terms and conditions of this
Agreement (including Section 5.5).
9.4 PROSECUTION.
(a) (i) Amgen shall be responsible (using mutually acceptable outside
counsel) for the filing, prosecution, defense and maintenance of the
Amgen Patent Rights and Joint Patent Rights before all patent
authorities in the Territory.
(ii) Hyseq shall have the right to review and comment on such
filing, prosecution and defense by Amgen of the Amgen Patent Rights and
Joint Patent Rights and if such outside counsel concludes that taking
any specific action(s) may likely have an adverse effect on the scope or
validity of any such Amgen Patent Rights or Joint Patent Rights, then
Amgen shall not take such specific action(s) without the prior express
written consent of Hyseq and Amgen shall propose an alternative strategy
for Hyseq's consideration. To that end, Amgen shall instruct such
outside counsel to furnish Hyseq with a reasonably complete draft of
each submission to a patent authority regarding Amgen Patent Rights and
Joint Patent Rights no later than twenty (20) days prior to the date
such submission is proposed to be made, or if given less than twenty
(20) days to respond as soon as practicable, and Amgen will reasonably
consider any of Hyseq's reasonably timely comments thereon.
Additionally, Amgen shall instruct such outside counsel to provide Hyseq
with a copy of each submission made to and document received from a
patent authority regarding any Amgen Patent Rights and Joint Patent
Rights reasonably promptly after making such filing or receiving such
document. If Amgen
27.
determines in its sole discretion to not file, prosecute, defend or
maintain any claim or patent application or patent within Amgen Patent
Rights and Joint Patent Rights in any country, then Amgen shall provide
Hyseq with thirty (30) days prior written notice of such determination
and shall provide Hyseq with the right and opportunity to file,
prosecute, defend and maintain such claim or patent application or
patent on behalf of Amgen.
(b) (i) Hyseq shall be responsible (using mutually acceptable outside
counsel which, unless there is a conflict of interest, shall be the
mutually acceptable outside counsel handling Amgen Patent Rights and
Joint Patent Rights pursuant to Section 9.4(a)) for the filing,
prosecution, defense and maintenance of Hyseq Patent Rights before all
patent authorities in the Territory.
(ii) Amgen shall have the right to review and comment on such
filing, prosecution and defense by Hyseq of the Hyseq Patent Rights and
if such outside counsel concludes that taking any specific action(s) may
likely have an adverse effect on the scope or validity of any such Hyseq
Patent Rights, then Hyseq shall not take such specific action(s) without
the prior express written consent of Amgen, and Hyseq shall propose an
alternative strategy for Amgen's consideration. To that end, Hyseq shall
instruct such outside counsel to furnish Amgen with a reasonably
complete draft of each submission to a patent authority regarding Hyseq
Patent Rights no later than twenty (20) days prior to the date such
submission is proposed to be made, or if given less than twenty (20)
days to respond as soon as practicable, and Hyseq will reasonably
consider any of Amgen's reasonably timely comments thereon.
Additionally, Hyseq shall instruct such outside counsel to provide Amgen
with a copy of each submission made to and document received from a
patent authority regarding any Hyseq Patent Rights reasonably promptly
after making such filing or receiving such document. If Hyseq determines
in its sole discretion to not file, prosecute, defend or maintain any
claim or patent application or patent within the Hyseq Patent Rights in
any country, then Hyseq shall provide Amgen with thirty (30) days prior
written notice of such determination and shall provide Amgen with the
right and opportunity to file, prosecute, defend and maintain such claim
or patent application or patent on behalf of Hyseq.
(c) Amgen and Hyseq shall each provide to the other any invention
disclosures submitted to its respective outside or in-house patent counsel in
the normal course of its business which disclose an invention within Amgen
Know-How, Hyseq Know-How or Joint Know-How, respectively. Amgen and Hyseq shall
cooperate with each other and render all reasonable assistance in prosecuting
and maintaining all intellectual property licensed under this Agreement. Both
Parties shall meet regularly, but not less than on a quarterly basis, to discuss
the prosecution (and other related proceedings, such as interferences and
oppositions) of all intellectual property licensed under this Agreement. Amgen
and Hyseq shall cooperate with each other in any such matters, and shall sign
any necessary legal papers and provide the Party responsible for such
prosecution with data or other information in support thereof (and use their
best efforts to ensure the cooperation of any of their respective personnel,
Affiliates and licensee(s) as might reasonably be requested).
28.
(d) The Commercial Lead shall be responsible (using mutually acceptable
outside counsel) for the filing, prosecution, defense and maintenance of the
Product Trademarks before all trademark authorities in the Territory. The other
Party shall have the right to review and comment on such filing, prosecution and
defense of the Product Trademarks by the Commercial Lead and if such outside
counsel concludes that taking any specific action(s) may likely have an adverse
effect on the scope or validity of any such Product Trademarks, then the
Commercial Lead shall not take such specific action(s) without the prior express
written consent of the other Party, and the Commercial Lead shall propose an
alternative strategy for the other Party's consideration. To that end, the
Commercial Lead shall instruct such outside counsel to furnish the other Party
with a reasonably complete draft of each submission to a trademark authority
regarding the Product Trademarks no later than twenty (20) days prior to the
date such submission is proposed to be made, or if given less than twenty (20)
days to respond as soon as practicable, and the Commercial Lead will consider
any of the other Party's reasonably timely comments thereon. Additionally, the
Commercial Lead shall instruct such outside counsel to provide the other Party
with a copy of each submission made to or document received from a trademark
authority regarding any Product Trademarks reasonably promptly after making such
filing or receiving such document. If the Commercial Lead determines in its sole
discretion to not file, prosecute, defend or maintain a Product Trademark in any
country, then the Commercial Lead shall provide the other Party with thirty (30)
days prior written notice of such determination and shall provide the other
Party with the right and opportunity to file, prosecute, defend and maintain
such Product Trademark on behalf of the Commercial Lead.
9.5 PATENT AND TRADEMARK EXPENSES.
(a) With respect to carrying out its responsibilities under Section 9.4,
Amgen shall have the right to charge the Operating Profit or Loss account for
all of Amgen's external costs, expenses and fees (as documented by written
invoices for legal services and receipts for filing, maintenance and other fees
paid) to have outside counsel prepare, file, ex parte prosecute and maintain
and/or defend Amgen Patent Rights, Joint Patent Rights and, if applicable,
Product Trademarks before all patent and trademark offices in the Territory
during the Term. Amgen shall obtain advance written consent from Hyseq (such
consent not to be unreasonably withheld) in the event any such ex parte expenses
collectively exceed [***] in any given Calendar Year; provided however, that the
costs, expenses and fees to defend such Patent Rights in any inter partes
actions before any such patent offices (including, without limitation,
interferences and oppositions) shall be excluded from such [***]. In the event
Hyseq does not consent to reimburse Amgen for such costs, expenses or fees in
excess of such [***] in a Calendar Year for any aspect related to preparing,
filing, ex parte prosecuting, maintaining or defending any of the Amgen Patent
Rights, Joint Patent Rights and Product Trademarks in the Territory during the
Term, Amgen shall not be obligated to continue any of its activities or to incur
any further costs or expenses related to such aspect.
(b) With respect to carrying out its responsibilities under Section 9.4,
Hyseq shall have the right to charge the Operating Profit or Loss account for
all of Hyseq's external costs, expenses and fees (as documented by written
invoices for legal services and receipts for filing, maintenance and other fees
paid) to have outside counsel prepare, file, ex parte prosecute and
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SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
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maintain, and/or defend Hyseq Patent Rights, any Amgen Patent Rights and Joint
Patent Rights (to the extent not pursued by Amgen) and, if applicable, Product
Trademarks before all patent and trademark offices in the Territory during the
Term. Hyseq shall obtain advance written consent from Amgen (such consent not to
be unreasonably withheld) in the event any such ex parte costs, expenses and
fees collectively exceed [***] in any given Calendar Year; provided however,
that the costs, expenses and fees to defend such Patent Rights in any inter
partes actions before any such patent offices (including, without limitation,
interferences and oppositions) shall be excluded from such [***]. In the event
Amgen does not consent to reimburse Hyseq for such costs, expenses or fees in
excess of such [***] in a Calendar Year for any aspect related to preparing,
filing, ex parte prosecuting, maintaining or defending any of the Hyseq Patent
Rights, any Amgen Patent Rights and Joint Patent Rights (to the extent not
pursued by Amgen), and Product Trademarks in the Territory during the Term,
Hyseq shall not be obligated to continue any of its activities or to incur any
further costs or expenses related to such aspect.
9.6 INFRINGEMENT OF COLLABORATION PATENT RIGHTS AND PRODUCT TRADEMARKS.
(a) Amgen Patent Rights and Joint Patent Rights.
(i) Amgen may, but shall not be obligated to, elect to enforce
Amgen Patent Rights and/or Joint Patent Rights and to enforce its rights
in Amgen Know-How and the Parties' rights in Joint Know-How against any
actual, alleged or threatened infringement by Third Parties and to
defend Amgen Patent Rights and/or Joint Patent Rights Amgen Know-How and
the Parties' rights in Joint Know-How against any challenges in the
Territory. In the event Amgen shall so elect to enforce Amgen Patent
Rights against a Third Party infringement which may in any way affect
the rights conferred pursuant to this Agreement to Hyseq to Develop,
manufacture and Commercialize Licensed Products and/or to enforce Joint
Patent Rights, Amgen shall seek and reasonably consider Hyseq's comments
before determining the strategy and Hyseq shall reasonably assist and
cooperate in any such enforcement or defense.
(ii) In the event Amgen does not commence an enforcement and/or
defense action pursuant to this Section 9.6(a) within [***] after Hyseq
notifies or is notified by Amgen in writing of an infringement of Amgen
Patent Rights which may in any way affect the rights conferred pursuant
to this Agreement to Hyseq to Develop, manufacture and Commercialize
Licensed Products and/or Joint Patent Rights in the Territory (or of the
filing of a declaratory judgment action), Hyseq shall be entitled to
bring and prosecute such an action. If Hyseq elects to bring and
prosecute such an action, then Hyseq shall
(b) Hyseq Patent Rights.
(i) Hyseq may, but shall not be obligated to, elect to enforce
Hyseq Patent Rights and its rights in Hyseq Know-How against any actual,
alleged or threatened infringement by Third Parties and to defend Hyseq
Patent Rights and Hyseq Know-How against any challenges in the
Territory. In the event Hyseq shall so elect, Hyseq shall
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seek and reasonably consider Amgen's comments before determining the
strategy and Amgen shall reasonably assist and cooperate in any such
enforcement or defense.
(ii) In the event Hyseq does not commence an enforcement and/or
defense action pursuant to this Section 9.6(b) within [***] after Amgen
notifies or is notified by Hyseq in writing of an infringement of Hyseq
Patent Rights in the Territory (or of the filing of a declaratory
judgment action), Amgen shall be entitled to bring and prosecute such an
action. If Amgen elects to bring and prosecute such an action, then
Amgen shall seek and reasonably consider Hyseq's comments on strategy.
(c) Product Trademarks.
(i) The Commercial Lead may, but shall not be obligated to,
enforce the Product Trademarks against any actual, alleged or threatened
infringement by Third Parties or from any unfair trade practices, trade
dress imitation, passing off of counterfeit goods or like offenses. In
the event the Commercial Lead shall so elect, the Commercial Lead shall
seek and reasonably consider the other Party's comments before
determining the strategy and the other Party shall reasonably assist and
cooperate in any such enforcement or defense.
(ii) In the event the Commercial Lead does not commence an
enforcement and/or defense action pursuant to this Section 9.6(c) within
[***] after the other Party notifies or is notified by the Commercial
Lead in writing of any actual, alleged or threatened infringement of the
Product Trademarks in the Territory (or of the filing of a declaratory
judgment action) or of any unfair trade practices, trade dress
imitation, passing off of counterfeit goods or like offenses, the other
Party shall be entitled to bring and prosecute such an action. If the
other Party elects to bring and prosecute such an action, then the other
Party shall seek and reasonably consider the Commercial Lead's comments
on strategy.
(d) The Party bringing suit under this Section 9.6 shall [***] for all
external costs, fees and expenses (including attorneys' fees of outside counsel)
incurred by such Party to carry out the activities described in this Section
9.6; and each Party shall [***] in carrying out the activities described in this
Section 9.6. Recoveries in any actions under this Section 9.6 [***].
9.7 INFRINGEMENT OF THIRD PARTY RIGHTS.
(a) The Commercial Lead shall have the first right to defend any actual,
alleged or threatened claim or action which names the Commercial Lead and/or
both Parties and which claims the infringement of (i) Third Party Patent Rights
or other intellectual property rights through the making, having made, using,
selling, offering to sell, importing exporting or otherwise transferring
physical possession of or otherwise transferring title in a Collaboration
Product or (ii) any Third Party trade name, service ▇▇▇▇, logo or trademark
(other than as set forth in Sections 14.1(d) or 14.2(d)). If necessary, the
other Party will assist and cooperate with the Commercial Lead in any such
defense.
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(b) The other Party shall have the right to defend any actual, alleged
or threatened claim or action which names the other Party but does not name the
Commercial Lead or, in the event the Commercial Lead elects not to defend, any
action naming both Parties and which claims the infringement of (i) Third Party
Patent Rights or other intellectual property rights through the making, having
made, using, selling, offering to sell, importing exporting or otherwise
transferring physical possession of or otherwise transferring title in a
Collaboration Product or (ii) any Third Party trade name, service ▇▇▇▇, logo or
trademark (other than as set forth in Sections 14.1(d) or 14.2(d)). If
necessary, the Commercial Lead will assist and cooperate with the other Party in
any such defense.
(c) A Party defending a suit pursuant to this Section 9.7 [***] for all
external costs and expenses (including attorneys' fees of outside counsel)
incurred in carrying out the activities described in this Section 9.7; and each
Party shall [***] incurred in carrying out the activities described in this
Section 9.7. Pursuant to Section 14.3, Losses in any actions under this Section
9.7 [***].
9.8 COOPERATION.
(a) Each Party shall promptly notify the other upon becoming aware of
(i) any actual, alleged or threatened Third Party claim or action against Hyseq
and/or Amgen for infringement of any Third Party trade name, service ▇▇▇▇, logo
or trademark through the Development, manufacturing or Commercialization of a
Collaboration Product; or Third Party Patent Rights or other intellectual
property rights through the making, having made, use, selling, offering to sell,
importing, exporting or otherwise transferring physical possession of or
otherwise transferring title in or to Collaboration Products in the Territory;
or (ii) any Third Party infringement of the Amgen Trademarks, Hyseq Trademarks,
Product Trademarks, Collaboration Patent Rights, Amgen Know-How, Hyseq Know-How
or Joint Know-How.
(b) The Parties shall confer with each other regarding the bringing or
defense of any suit under Section 9.6 and/or 9.7 including, if necessary [***].
If the Party bringing or defending such suit finds it necessary or desirable to
[***].
(c) Neither Party shall enter into any settlement of any suit brought or
defended under Section 9.6 and/or 9.7 that affects the other Party's rights or
interests [***].
(d) A Party bringing or defending suit under Section 9.6 and/or 9.7
shall notify the other Party of all substantive developments with respect to
such enforcement or defensive actions including, but not limited to, all
material filings, court papers and other related documents, substantive
settlement negotiations and offer of settlement.
9.9 WAIVER.
(a) Hyseq, on behalf of itself and its directors, employees, officers,
shareholders, agents, successors and assigns hereby waives any and all actions
and causes of action, claims and demands whatsoever, in law or equity, of any
kind it or they may have against Amgen, its directors, employees, officers,
shareholders, agents, successors and assigns which may arise in
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any way, except as a result of Amgen's gross negligence, recklessness or
willful misconduct in the performance of its rights or obligations under
Sections 9.4, 9.6, 9.7, 9.10 and 9.11.
(b) Amgen, on behalf of itself and its directors, employees, officers,
shareholders, agents, successors and assigns hereby waives any and all actions
and causes of action, claims and demands whatsoever, in law or equity, of any
kind it or they may have against Hyseq, its directors, employees, officers,
shareholders, agents, successors and assigns which may arise in any way, except
as a result of Hyseq's gross negligence, recklessness or willful misconduct in
the performance of its rights or obligations under Sections 9.4, 9.6, 9.7, 9.10
and 9.11.
9.10 TECHNICAL ASSISTANCE. In addition to other assistance explicitly
set forth in this Agreement, during the period of the Term, Amgen and Hyseq
shall each provide the other Party with reasonable technical assistance relating
to the use of such Amgen Know-How and Hyseq Know-How, respectively, and Joint
Know-How solely to the extent permitted under the license(s) granted to the
other Party in this Agreement. In addition, during the Term each Party shall
make its employees, consultants and agents reasonably available upon reasonable
notice during normal business hours at their respective places of employment to
consult with the other Party on issues relating to any aspect of the subject
matter of this Agreement and in connection with any request from any Regulatory
Authority, including those relating to regulatory, scientific and technical
issues.
9.11 EMPLOYEE OBLIGATIONS. Prior to beginning work relating to any
aspect of the subject matter of this Agreement and/or being given access to
Hyseq Know-How, Amgen Know-How or Joint Know-How or the Confidential Information
of the other Party, each employee, consultant or agent of Hyseq and Amgen shall
have signed or shall be required to sign a non-disclosure and invention
assignment agreement pursuant to which each such person shall agree to comply
with all of the obligations of Hyseq or Amgen, as appropriate, substantially
including: (a) promptly reporting any invention, discovery, process, software
program or other intellectual property right, as appropriate within Hyseq
Know-How, Amgen Know-How or Joint Know-How; (b) assigning to Hyseq or Amgen, as
appropriate, all of his or her right, title and interest in and to any such
invention, discovery, process, software program or other intellectual property
right; (c) cooperating in the preparation, filing, prosecution, maintenance,
enforcement and defense of any Collaboration Patent Rights and the enforcement
and defense of Amgen Know-How, Hyseq Know-How and Joint Know-How; (d) performing
all acts and signing, executing, acknowledging and delivering any and all
papers, documents and instruments required for effecting the obligations and
purposes of this Agreement and (e) abiding by the obligations of confidentiality
and non-use set forth in this Agreement. It is understood and agreed that any
such non-disclosure and invention assignment agreement need not be specific to
this Agreement.
9.12 PATENT MARKING. Collaboration Products marketed and sold by the
Commercial Lead hereunder shall be marked with appropriate patent numbers or
indicia of Collaboration Patent Rights, to the extent permitted by law in those
countries of the Territory in which such markings have notice value as against
infringers of patents.
33.
9.13 THIRD PARTY RESEARCH AGREEMENTS. The Parties shall, through the
Steering Committee, agree upon and coordinate Third Party material transfer
agreements and collaboration agreements with academic or governmental research
institutions related to the Development of Collaboration Products or involving
the use of Collaboration Products, in a manner so as to conserve the available
quantities of the Parties' research materials and to avoid compromise of the
Parties' abilities to fulfill their responsibilities under the Program Plan and
so as to maintain access to relevant intellectual property rights. The form of
any such Third Party material transfer agreement or collaboration agreement
shall be agreed upon by the Parties. Notwithstanding the above, other than with
respect to Collaboration Products, neither Party may transfer the other Party's
Materials to any such academic or governmental research institution, without the
express written consent of the other Party. In the event any invention or
know-how resulting from such material transfer agreement or collaboration
agreement has applicability outside the scope of this Agreement, and both
Parties desire to have access to such invention or know-how for uses outside the
scope of this Agreement, the Parties shall ensure that they each have the
opportunity to separately license the rights to such invention or know-how.
ARTICLE 10
PAYMENTS; RECORDS; AUDIT
10.1 PAYMENTS.
(a) U.S. Dollars. All payments to be made under this Agreement shall be
made in U.S. Dollars by bank wire transfer in immediately available funds to a
bank account designated from time-to-time by the Party receiving the funds.
(b) Foreign Exchange. Currencies other than United States Dollars shall
be converted into the United States Dollar equivalent at the average rate of
exchange for the Calendar Quarter to which such payments relate (as reported in
Bloomberg Professional, a service of Bloomberg L.P.) or in the event Bloomberg
Professional is not available then The Wall Street Journal, for the currency of
the country in which the sale is made.
(c) Late Payments. Any amounts not paid by a Party when due under this
Agreement shall be subject to interest from and including the date payment is
due through and including the date upon which such Party has made a wire
transfer of immediately available funds into an account designated by the other
Party of such payment at a rate equal to the lesser of (i) the sum of [ ] plus
the annual prime rate or successive annual prime rates of interest quoted in the
Money Rates section of the on-line edition of the Wall Street Journal (at
▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇▇) calculated daily on the basis of a 365-day year
or (ii) the highest rate permitted by applicable law.
(d) Blocked Currency. With respect to receipt of a foreign currency for
sales of Collaboration Products, if the Commercial Lead and its Affiliates are
unable to convert such foreign currency into United States Dollars for reasons
beyond their respective control, or are restricted by law or regulation from
remitting funds from any country of sale, the Commercial Lead shall cause such
payment to be made by deposit to the credit and account of both Parties (or
34.
their respective nominee(s)) in any commercial bank designated by the Commercial
Lead in the applicable country. The Commercial Lead shall deliver to the other
Party proper evidence of such deposit.
(e) Withholding Taxes. Any taxes, assessments and fees to be withheld by
the Commercial Lead under the laws, rules or regulations of any foreign country
for the account of the other Party shall be promptly paid by the Commercial Lead
for and on behalf of the other Party to the appropriate governmental authority,
and the Commercial Lead shall furnish the other Party with an original copy of
the official receipt for the payment of such tax within [***] of payment. Any
such tax, assessment and fee actually paid on the other Party's behalf shall be
deducted from any payments due to the other Party. The Commercial Lead agrees to
make all lawful and reasonable efforts to minimize such taxes, assessments and
fees to the other Party.
10.2 RECORDS; AUDIT. The Parties shall keep or cause to be kept such
records as are required in sufficient detail to track and determine, in a manner
consistent with GAAP, the accuracy of calculations of all sums or credits due
under this Agreement to accurately account for all items within the Operating
Profit or Loss account. Such records shall be retained for a period of the later
of: (i) a [***] period following the year in which any payments were made
hereunder, and (ii) the expiration of the applicable tax statute of limitations
(or any extensions thereof), or such longer period as may be required by law.
Once per Calendar Year each Party shall have the option to engage, at its own
expense, an independent certified public accountant, appointed by the auditing
Party and reasonably acceptable to the audited Party, to examine in confidence
the books and records of the Party being audited as may be necessary to
determine, with respect to any Calendar Year, the correctness or completeness of
any report or payment required to be made under this Agreement; provided
however, that the books and records for any particular Calendar Year shall only
be subject to one audit. The report of such accountant shall be limited to a
certificate verifying any report made or payment submitted by the audited Party
during such period but may include, in the event the accountant shall be unable
to verify the correctness of any such payment, information relating to why such
payment is unverifiable. All information contained in any such certificate shall
be deemed the Confidential Information of the audited Party hereunder. If any
audit performed under this Section 10.2 (showing the calculation of a
reimbursement or payment amount) discloses a variance of more than [***] from
the amount of the original report, the audited Party shall bear the full cost of
the performance of such audit. Upon the expiration of [***] following the end of
any particular Calendar Year, the calculation of any such amounts payable with
respect to such particular Calendar Year shall be binding and conclusive upon a
Party entitled to such audit and the other Party or its Affiliates shall be
released from any liability or accountability with respect to such amounts for
such Calendar Year.
ARTICLE 11
PUBLICATIONS
11.1 PROCEDURE. The Steering Committee shall determine the overall
strategy for publication and presentation of results of pre-clinical and
clinical studies of Collaboration Products. [***]. Each Party to this Agreement
recognizes that the publication of papers
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regarding results of and other information regarding the activities under this
Agreement, including oral presentations and abstracts, may be beneficial to both
Parties provided such publications are subject to reasonable controls to protect
Confidential Information. In particular, it is the intent of the Parties to
maintain the confidentiality of any Confidential Information included in any
patent application until such patent application has been published.
Accordingly, each Party will have the right to review and approve any paper
proposed for publication by the other Party, including oral presentations and
abstracts, which utilizes data generated under this Agreement and/or includes
Confidential Information of the other Party. Before any such paper is submitted
for publication or an oral presentation is made, the Party publishing or
presenting will deliver a complete copy of the paper or materials and abstracts
for oral presentation to the other Party at least [***] prior to submitting the
paper to a publisher or making the presentation. The other Party will review any
such paper and give its comments to the publishing Party within [***] after the
delivery of such paper to the other Party. With respect to oral presentation
materials and abstracts, the other Party will make reasonable efforts to
expedite review of such materials and abstracts, and will return such items as
soon as practicable to the presenting Party with appropriate comments, if any,
but in no event later than [***] after the date of delivery to the other Party.
The publishing Party will comply with the other Party's request to delete
references to the other Party's Confidential Information in any such paper,
materials and abstracts and agrees to withhold publication of same for an
additional [***] in order to permit the Parties to obtain patent protection, if
either of the Parties deems it necessary, in accordance with the terms of this
Agreement.
11.2 CREDIT. Any such publication or presentation will include
recognition of the contributions of the other Party according to standard
practice for assigning scientific credit, either through authorship or
acknowledgment, as may be appropriate.
ARTICLE 12
CONFIDENTIALITY
12.1 TREATMENT OF CONFIDENTIAL INFORMATION. The Parties agree that
during the Term, and for a period of [***] after this Agreement expires or
terminates, a Party receiving Confidential Information of the other Party shall
(a) maintain in confidence such Confidential Information to the same extent such
Party maintains its own confidential or proprietary information or trade secrets
of similar kind and value (but at a minimum each Party shall use reasonable best
efforts to maintain such Confidential Information in confidence); (b) not
disclose such Confidential Information to any Third Party without the prior
written consent of the disclosing Party, except for disclosures to its
Affiliates and, pursuant to Section 18.7, to authorized subcontractors who agree
to be bound by obligations of non-disclosure and non-use at least as stringent
as those contained in this Article 12; and (c) not use such Confidential
Information for any purpose except those purposes permitted by this Agreement.
Neither Party shall knowingly disclose to the other Party any Third Party
information or know-how that such Party does not have the legal right to
disclose to the other Party and/or has a contractual obligation not to disclose
to the other Party.
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12.2 AUTHORIZED DISCLOSURE. Notwithstanding any other provision of this
Agreement, a Party may disclose Confidential Information of the other Party:
(a) to the extent and to the persons and entities as required by an
applicable law, rule, regulation, legal process, court order or the rules of the
National Association of Securities Dealers or of a Regulatory Authority;
(b) as necessary to file, prosecute or defend those patent applications
or patents for which either Party has the right to assume filing, prosecution,
defense or maintenance, pursuant to Section 9.4 of this Agreement;
(c) to prosecute or defend litigation or otherwise establish rights or
enforce obligations pursuant to this Agreement, but only to the extent that any
such disclosure is necessary; or
(d) in the event of a Recall, by the Party responsible for such Recall
pursuant to Section 4.9.
The Party required or intending to disclose the other Party's Confidential
Information under Sections 12.2(a) or (c) shall first have given prompt notice
to such other Party to enable it to seek any available exemptions from or
limitations on such disclosure requirement and shall reasonably cooperate in
such efforts by the other Party.
12.3 TRANSFER OF MATERIALS. For purposes of this Agreement, the Parties
anticipate that each Party may transfer certain of its Materials to the other
Party. Each Party agrees that it will use such Materials of the other Party only
in accordance with the terms and conditions of this Agreement and will not
transfer such Materials to any Third Party without the consent of the other
Party, except as expressly permitted under this Agreement.
12.4 PUBLICITY; TERMS OF AGREEMENT. The Parties agree that the existence
of and the material terms of this Agreement shall be considered Confidential
Information of both Parties, subject to the special authorized disclosure
provisions set forth below in this Section 12.4 (in lieu of the authorized
disclosure provisions set forth in Section 12.2, to the extent of any conflict)
and without limiting the generality of the definition of Confidential
Information. The Parties will mutually agree on the text of a press release
announcing the execution of this Agreement. Thereafter, if either Party desires
to make a public announcement concerning this Agreement or the terms hereof,
such Party shall give reasonable prior advance notice of the proposed text of
such announcement to the other Party for its prior review and approval, such
approval not to be unreasonably withheld or delayed. A Party shall not be
required to seek the permission of the other Party to repeat any information as
to the terms of this Agreement that has already been publicly disclosed by such
Party in accordance with the foregoing or by the other Party. Either Party may
disclose the terms of this Agreement to potential investors who agree to be
bound by obligations of non-disclosure and non-use at least as stringent as
those contained in this Article 12. The Parties acknowledge that Amgen and/or
Hyseq may be obligated to file a copy of this Agreement with the U.S. Securities
and Exchange Commission with its next quarterly report on Form 10-Q, an annual
report on Form 10-K or a current report on Form 8-K or with any
37.
registration statement filed with the U.S. Securities and Exchange Commission
pursuant to the Securities Act of 1933, as amended, and each such Party shall be
entitled to make such filing, provided however, that it requests confidential
treatment of the more sensitive terms hereof to the extent such confidential
treatment is reasonably available to the filing Party under the circumstances
then prevailing. In the event of any such filing, the filing Party will provide
the non-filing Party with an advance copy of the Agreement marked to show
provisions for which the filing Party intends to seek confidential treatment,
and the filing Party shall reasonably consider the non-filing Party's timely
comments thereon.
ARTICLE 13
REPRESENTATIONS, WARRANTIES AND COVENANTS
13.1 MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents
and warrants to the other Party that as of the Effective Date:
(a) Power and Authority. It has the corporate power, authority and legal
right to enter into this Agreement and perform its obligations hereunder and has
taken all necessary corporate action on its part required to authorize the
execution and delivery of the Agreement and the performance of its obligations
hereunder, including without limitation the right to grant the licenses
hereunder.
(b) Binding Agreement. This Agreement has been duly executed and
delivered on behalf of Hyseq and constitutes a legal, valid and binding
obligation of Hyseq that is enforceable against it in accordance with its terms.
(c) No Conflict. The execution, delivery and performance of this
Agreement does not conflict with, and would not result in a breach of any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.
(d) Validity. It is aware of no action, suit, inquiry or investigation
instituted by any Third Party which questions or threatens the validity of this
Agreement.
(e) Business Condition. It is not in violation of its charter, bylaws,
or any other organizational document, or in violation of any law, administrative
regulation, ordinance or order of any court or governmental agency, arbitration
panel or authority applicable to it, which violation, individually or in the
aggregate, would reasonably likely have a materially adverse effect on its
business or financial condition. Except as may be set forth in any documents
filed with the Securities and Exchange Commission, as required to be filed by it
under the Securities Act or Exchange Act, as the case may be, it is not aware of
any facts or circumstances, individually or in the aggregate, which would
reasonably likely have a materially adverse effect on its business or financial
condition.
38.
13.2 MUTUAL COVENANTS. Each Party hereby covenants to the other Party as
follows:
(a) No Misappropriation. It shall not knowingly misappropriate the trade
secret of a Third Party in its activities to Develop, manufacture or
Commercialize Collaboration Products.
(b) No Debarment. In the course of the Development, manufacture and
Commercialization of Collaboration Products and during the Term, such Party
shall not knowingly use and shall not have knowingly used any employee or
consultant who is or has been debarred by a Regulatory Authority or, to the best
of such Party's knowledge, is or has been the subject of debarment proceedings
by a Regulatory Authority.
(c) No Conflict. It shall not during the term of this Agreement grant
any right, license, consent or privilege to any Third Party(ies) in the
Territory which would conflict with the rights granted to the other Party under
this Agreement, and shall not take any action that would in any way prevent it
from assuming its obligations or granting the rights granted to the other Party
under this Agreement or that would otherwise materially conflict with or
adversely affect its obligations or its assumption of the rights granted to the
other Party under this Agreement.
(d) Exclusivity. It shall work exclusively with the other Party with
respect to Collaboration Products. It shall not, directly or indirectly, make,
have made, use, sell, offer to sell, import, export or otherwise transfer
physical possession of or otherwise transfer title in (for purposes of
Developing, manufacturing or Commercializing) a [***] in the Territory, nor
license or otherwise enable a Third Party to take such actions during the Term.
[***].
(e) Compliance. Each Party shall comply with all applicable statutes,
regulations and guidance of Regulatory Authorities in carrying out its
respective activities regarding the Development, manufacture and
Commercialization of Collaboration Products in the Territory.
(f) Regulatory Data. It shall store and provide the other Party access
to source data supporting all Regulatory Filings and Regulatory Approvals for
the longer of (i) [***] or (ii) the time period required by any applicable
Regulatory Authority in the Territory. Prior to initiation of the first Phase II
Clinical Trial of the first Collaboration Product, it shall also make its
employees, consultants and agents reasonably available upon reasonable notice
from the other Party to consult with the other Party on issues relating to the
Collaboration Product or relating to requests from any Regulatory Authority in
the Territory.
(g) Formation of Legal Entity. In the event either Party determines that
the formation of a partnership or other legal entity co-owned by the Parties to
further the Development, manufacture and Commercialization of the Collaboration
Products would be beneficial for legal, tax or other reasons, the other Party
covenants that it shall cooperate and take all reasonable steps necessary to
form such entity.
13.3 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF HYSEQ.
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(a) Corporate Existence. Hyseq hereby represents and warrants to Amgen
that as of the Effective Date of this Agreement it is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Nevada, and has full corporate power and authority and the legal right to own
and operate its property and assets and to carry on its business as it is now
being conducted and as contemplated in this Agreement.
(b) Expertise. In entering into this Agreement, Hyseq hereby represents
and warrants to Amgen that as of the Effective Date of this Agreement it has
[***].
(c) Diligence. Hyseq covenants that it shall use Commercially Reasonable
Efforts to carry out its obligations in accordance with the terms of this
Agreement including, as applicable, the Development, manufacture and
Commercialization of Collaboration Products in the Territory in accordance with
the terms of this Agreement. Without limiting the generality of the foregoing
obligation, Hyseq covenants that:
(i) Hyseq shall use Commercially Reasonable Efforts to
administer a Collaboration Product to a patient in a government-approved
clinical trial within [***] after the Effective Date. In the event Hyseq
fails to administer a Collaboration Product in such time period then,
within [***] after the Effective Date, Hyseq shall either pay Amgen a
[***] maintenance fee or Amgen may terminate this Agreement in
accordance with Section 16.3.
(ii) Hyseq shall use Commercially Reasonable Efforts to
administer a Collaboration Product to a patient in a government-approved
clinical trial within [***] after the Effective Date. In the event Hyseq
fails to administer a Collaboration Product in such time period then, in
addition to any payment that may have been due under subsection (i)
above and within [***] after the Effective Date, in addition to the
payment in subsection (i) above, Hyseq will either pay Amgen a [***]
maintenance fee or Amgen may terminate this Agreement in accordance with
Section 16.3.
(iii) Hyseq shall use Commercially Reasonable Efforts to
administer a Collaboration Product to a patient in a government-approved
clinical trial within [***] after the Effective Date. In the event Hyseq
fails to administer such Collaboration Product in such time period, then
Amgen shall have the right to terminate this Agreement in accordance
with Section 16.3.
13.4 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF AMGEN.
(a) Corporate Existence. Amgen hereby represents and warrants to Hyseq
that as of the Effective Date of this Agreement it is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Delaware, and has full corporate power and authority and the legal right to own
and operate its property and assets and to carry on its business as it is now
being conducted and as contemplated in this Agreement.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
40.
(b) Diligence. Amgen covenants that it shall use Commercially Reasonable
Efforts to carry out its obligations under the terms of this Agreement
including, as applicable, the Development, manufacture and Commercialization of
Collaboration Products.
13.5 DISCLAIMERS. EXCEPT AS EXPRESSLY PROVIDED HEREIN, THE mATERIALS AND
iNFORMATION PROVIDED HEREUNDER ARE BEING PROVIDED "AS IS" AND WITHOUT ANY
REPRESENTATIONS OR WARRANTIES. NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, OF ANY TYPE WHATSOEVER REGARDING THE mATERIALS
AND iNFORMATION. EACH PARTY EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY,
OF FITNESS FOR A PARTICULAR PURPOSE OR OF NONINFRINGEMENT.
ARTICLE 14
INDEMNIFICATION
14.1 INDEMNIFICATION BY AMGEN. Amgen hereby agrees to defend, hold
harmless and indemnify (collectively "Indemnify" or "Indemnified") Hyseq and its
Affiliates, agents, directors, officers and employees (the "Hyseq Indemnitees")
from and against any and all Losses resulting directly or indirectly from any
Third Party claims, suits, actions or demands, whether brought during or after
the Term, arising out of (a) any of Amgen's representations and warranties set
forth in this Agreement being untrue in any material respect when made; (b) any
material breach or material default by Amgen of its covenants and obligations
under this Agreement; (c) Amgen's carrying out of activities outside the Program
Plan during the Term or Amgen's [***] of any Third Party engaged by Amgen) in
carrying out its activities set forth in the Program Plan including, without
limitation, manufacturing and Commercialization activities of Amgen; and/or (d)
resulting solely from Hyseq's proper use of Amgen's Trademarks in connection
with a Collaboration Product in accordance with the terms of this Agreement. To
be eligible to be so Indemnified as described in this Section 14.1, the Hyseq
Indemnitees shall provide Amgen with prompt notice of any claims, suits, actions
or demands (with a description of the claim and the nature and amount of any
such Loss) giving rise to the indemnification obligation pursuant to this
Section 14.1 and the exclusive ability to defend such claims, suits, actions or
demands (with the reasonable cooperation of Hyseq Indemnitees); provided
however, that Amgen shall be relieved of its obligations only if any failure by
the Hyseq Indemnitee to deliver prompt notice shall have been prejudicial to its
ability to defend such claims, suits, actions or demands. Hyseq shall have the
right to retain its own counsel, at its own expense, if representation of the
counsel of Amgen would be inappropriate due to actual or potential differing
interests between the Parties. Neither Party shall settle or consent to the
entry of any judgment with respect to any claim for Loss for which
indemnification is sought, [***]. Amgen's obligation to Indemnify the Hyseq
Indemnitees pursuant to this Section 14.1 shall not apply to the extent of any
Losses (i) that arise from the [***] of any Hyseq Indemnitee (including but not
limited to that arising from the Development or Commercialization of a
Collaboration Product by Hyseq); (ii) that arise from Hyseq's breach of any
representation, warranty, covenant or obligation under this Agreement; or (iii)
for which Hyseq is obligated to Indemnify the Amgen Indemnitees pursuant to
Section 14.2 of this Agreement.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
41.
14.2 INDEMNIFICATION BY HYSEQ. Hyseq hereby agrees to Indemnify Amgen
and its Affiliates, agents, directors, officers and employees (the "Amgen
Indemnitees") from and against any and all Losses resulting directly or
indirectly from any Third Party claims, suits, actions or demands, whether
brought during or after the Term, arising out of (a) any of Hyseq's
representations and warranties set forth in this Agreement being untrue in any
material respect when made; (b) any material breach or material default by Hyseq
of its covenants and obligations under this Agreement; (c) Hyseq's carrying out
of activities outside the Program Plan during the Term or Hyseq's [***] of any
Third Party engaged by Hyseq) in carrying out its activities set forth in the
Program Plan including, without limitation, Development activities of Hyseq;
and/or (d) resulting solely from Amgen's proper use of Hyseq's Trademarks in
connection with a Collaboration Product in accordance with the terms of this
Agreement. To be eligible to be Indemnified as described above in this Section
14.2, the Amgen Indemnitees shall provide Hyseq with prompt notice of any
claims, suits, actions or demands (with a description of the claim and the
nature and amount of any such Loss) giving rise to the indemnification
obligation pursuant to this Section 14.2 and the exclusive ability to defend
such claims, suits, actions or demands (with the reasonable cooperation of Amgen
Indemnitees); provided however, that Hyseq shall be relieved of its obligations
only if any failure by the Amgen Indemnitee to deliver prompt notice shall have
been prejudicial to its ability to defend such claims, suits, actions or
demands. Amgen shall have the right to retain its own counsel, at its own
expense, if representation of the counsel of Hyseq would be inappropriate due to
actual or potential differing interests between the Parties. Neither Party shall
settle or consent to the entry of any judgment with respect to any claim for
Loss for which indemnification is sought, [***]. Hyseq's obligation to Indemnify
the Amgen Indemnitees pursuant to this Section 14.2 shall not apply to the
extent of any Losses (i) that arise from the [***] of any Amgen Indemnitee
(including but not limited to that arising from the manufacture or
Commercialization of Collaboration Product by Amgen); (ii) that arise from
Amgen's breach of any representation, warranty, covenant or obligation under
this Agreement; or (iii) for which Amgen is obligated to Indemnify the Hyseq
Indemnitees pursuant to Section 14.1 of this Agreement.
14.3 JOINT LIABILITY. Other than as set forth in Section 14.1 or 14.2
and after exhausting the minimum insurance coverage as listed in the table in
Section 14.4, any and all Losses arising from Third Party claims, suits, actions
or demands, whether brought during or after the Term, resulting directly or
indirectly out of the making, having made, using, selling, having sold, offering
for sale or resale, and/or otherwise Developing, manufacturing, or
Commercializing Collaboration Products (including a claim that a Collaboration
Product caused death or personal injury of any kind) during the Term [***] at
the time such claim is finally determined, whether by judgment, award, decree or
settlement. For avoidance of doubt, prior to Hyseq [***]. In the event a Party
becomes aware of a claim which, if resulting in a Loss, it intends to [***],
such Party shall inform the other Party of such claim [***] after it receives
notice thereof. Subject to Section 9.7, Hyseq shall have the right to assume
direction and control of the defense of any claim alleging a date of injury (or
in the event of a continuing injury alleging the then-most recent date of
injury) to be prior to the Transition Date of the first Collaboration Product,
and Amgen shall have the right to assume direction and control of the defense of
any claim alleging a date of injury (or in the event of a continuing injury
alleging the then-most recent date of injury) to be upon or after the Transition
Date of the first Collaboration
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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Product. The Party not in control of such defense shall [***] in the defense of
the claim and if the Party in control of such defense finds it necessary or
desirable to [***]; provided however, that the other Party shall have the right
to retain its own counsel, at its own expense, if representation by the counsel
of the Party in control would be inappropriate due to actual or potential
differing interests between the Parties. Neither Party shall settle or consent
to the entry of any judgment with respect to any claim for Losses associated
with such claim [***].
14.4 INSURANCE. Within thirty (30) days after the Effective Date, each
Party shall at its own expense procure and maintain during the Term and for a
period of [***] thereafter an insurance policy/policies, including product
liability insurance (but excluding clinical trial insurance policies which shall
be required only while trials are ongoing), adequate to cover its obligations
hereunder and which is/are consistent with normal business practices of prudent
companies similarly situated. Amgen may self-insure and Hyseq may self-insure
all or part of any such obligation consistent with pharmaceutical industry
practices but Hyseq shall at all times maintain the following minimum Third
Party insurance coverage:
TYPE OF COVERAGE AMOUNT
---------------- ------
Commercial General Liability Insurance [***]
Product Liability Insurance [***]
Excess Liability Insurance [***]
Clinical Trial Liability Insurance [***]
▇▇▇▇▇▇▇'▇ Compensation [***]
Each insurance policy required by and procured by a Party under this
Section 14.4 shall name the other Party as an additional insured. Such insurance
shall not be construed to create a limit of the insuring Party's liability with
respect to its indemnification obligations under this Article 14. Each Party
shall provide the other Party with a certificate of insurance or other evidence
of such insurance and/or self-insurance, upon request. Each Party shall provide
the other Party with written notice at least thirty (30) days prior to the
cancellation, non-renewal or a material change in such insurance or
self-insurance which materially adversely affects the rights of the other Party
hereunder.
14.5 PRE-EFFECTIVE DATE LOSSES. In connection with this Agreement, Hyseq
shall not assume or be liable for any Losses resulting from or arising in
connection with the use by Amgen (or any Third Party under Amgen's direction) of
any Collaboration Product on or prior to the Effective Date.
14.6 LIMITATION OF LIABILITY. NEITHER PARTY NOR ITS RESPECTIVE
AFFILIATES SHALL BE LIABLE FOR SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE
DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE
INCURRED BY THE OTHER PARTY
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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IN CONNECTION WITH THIS AGREEMENT, INCLUDING BUT NOT LIMITED TO DAMAGES
MEASURING LOST PROFITS OR BUSINESS OPPORTUNITIES.
ARTICLE 15
COLLABORATION OPT OUT
15.1 AMGEN'S OPT-OUT RIGHT. Subject to this Article 15, Amgen shall have
the right to elect to opt out of this Agreement and to grant Hyseq an exclusive
license (even as to Amgen) under the terms and conditions as set forth in that
certain License Agreement attached hereto as Schedule IV, at which time this
Agreement shall be terminated in accordance with Section 16.8.
15.2 EXERCISE. Amgen may exercise the opt-out right described in Section
15.1 by providing Hyseq with written notice thereof at any time between [***].
Notwithstanding the foregoing, if Hyseq, after the foregoing [***], Amgen's
opt-out right under this Article 15 [***] as provided in this Section 15.2.
15.3 LICENSE AGREEMENT. In the event Amgen shall have exercised its
right pursuant to Section 15.1, Hyseq and Amgen shall execute the License
Agreement attached hereto as Schedule IV not less than [***] following Amgen's
written notification provided under Section 15.2.
ARTICLE 16
TERM AND TERMINATION
16.1 TERM. This Agreement shall become effective on the Effective Date
and shall remain in full force and effect, unless earlier terminated pursuant to
this Article 16, for such time as the Collaboration Products are being Developed
or Commercialized by the Parties.
16.2 TERMINATION FOR CONVENIENCE. Hyseq may terminate this Agreement at
any time by providing ninety (90) days prior written notice of termination to
Amgen. The effects of such termination will occur in accordance with Section
16.9(a).
16.3 TERMINATION BY AMGEN. In the event Hyseq shall not timely pay any
maintenance fees due pursuant to either Section 13.3(c)(i) or 13.3(c)(ii) or
shall not timely administer a Collaboration Product to a patient pursuant to
Section 13.3(c)(iii), Amgen shall have the right, in its sole discretion, to
terminate this Agreement by providing thirty (30) days prior written
notification of termination to Hyseq. The effects of such termination will occur
in accordance with Section 16.9(a).
16.4 TERMINATION FOR MATERIALLY ADVERSE CLINICAL DEVELOPMENT. If, in the
good faith opinion of Amgen, the results of any clinical trial or of any
decision by a Regulatory Authority regarding a Collaboration Product constitutes
a materially adverse change in the commercial prospects or prospects for
approval of any Collaboration Product, then Amgen may terminate this Agreement
by providing thirty (30) days prior written notification of termination to
Hyseq. The effects of such termination will occur in accordance with Section
16.9(c).
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
44.
16.5 MUTUAL CONSENT. This Agreement shall terminate upon the mutual
written consent of the Parties and, unless otherwise specified in such written
consent, shall be effective thirty (30) days after the date of last signature of
the Parties to such mutual written consent. The effects of such termination will
occur in accordance with Section 16.9(b).
16.6 TERMINATION FOR DEFAULT.
(a) In the event any material representation or warranty made hereunder
or under the Warrant Purchase Agreement by either Party shall have been untrue
in any material respect ("Representation Default"), or upon any material breach
or material default of a material obligation of this Agreement or the Warrant
Purchase Agreement by a Party ("Performance Default"), the Party not in default
("Non-Defaulting Party") must first give the other Party ("Defaulting Party")
written notice thereof ("Notice of Default"), which notice must state the nature
of the Representation Default or Performance Default in reasonable detail and
must request the Defaulting Party cure such Representation Default or
Performance Default within sixty (60) days. During any such 60-day period after
receipt or delivery of a Notice of Default under this Section 16.6(a) for which
termination of this Agreement, in whole or in part, is a remedy, all of the
Party's respective rights and obligations under the affected parts of this
Agreement, including but not limited to Development, manufacture and
Commercialization, shall (to the extent applicable) remain in force and effect.
If the Defaulting Party shall dispute the existence, extent or nature of any
default set forth in a Notice of Default, the Parties shall use good faith
efforts to resolve the dispute.
(b) Hyseq Default. In the event of a Representation Default or a
Performance Default by Hyseq that shall not have been cured within the period
set forth in Section 16.6(a) above after receipt of a Notice of Default, Amgen,
at its option, may terminate this Agreement upon sixty (60) days prior written
notice, unless such Representation Default is an unintentional Representation
Default of the Warranty Agreement and Amgen did not provide Notice of Default
within one (1) year after the Effective Date. The effects of such termination
will occur in accordance with Section 16.9(a). In addition, in the event of
termination pursuant to such uncured Representation Default as provided in the
foregoing sentence, Amgen will be entitled to receive a refund of all money
paid.
(c) Amgen Default. In the event of a Representation Default or a
Performance Default by Amgen that shall not have been cured within the period
set forth in Section 16.6(a) after receipt of a Notice of Default, Hyseq, at its
option, may terminate this Agreement upon sixty (60) days prior written notice.
The effects of such termination will occur in accordance with Section 16.9(c).
In addition, in the event of termination pursuant to such uncured Representation
Default as provided in the foregoing sentence, Hyseq will be entitled to receive
a refund of all money paid.
45.
16.7 BANKRUPTCY.
(a) Amgen may terminate the Agreement if Hyseq shall file in any court
or agency pursuant to any statute or regulation of any state or country, a
petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver or trustee of Hyseq or of its assets, or if
Hyseq proposes a written agreement of composition or extension of its debts, or
if Hyseq shall be served with an involuntary petition in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up arrangement, composition or
readjustment of its debts or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction now or hereafter
in effect, or there shall have been issued a warrant of attachment, execution,
distraint or similar process against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within ninety (90) days after the filing
thereof, or if Hyseq shall propose or be a party to any dissolution or
liquidation, or if Hyseq shall make an assignment for the benefit of creditors.
The effects of such termination will occur in accordance with Section 16.9(a).
(b) All rights and licenses granted under or pursuant to this Agreement
by Amgen or Hyseq 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 of the U.S. Bankruptcy Code. The Parties
agree that each Party 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 a bankrupt
Party under the U.S. Bankruptcy Code, the other Party shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any intellectual
property and all embodiments of such intellectual property, and same, if not
already in the other Party's possession, shall be promptly delivered to the
other Party (a) upon any such commencement of a bankruptcy proceeding, upon the
other Party's written request therefor, unless the non-bankrupt Party (or a
trustee on behalf of the non-bankrupt Party) elects to continue to perform all
of its obligations under this Agreement or (b) if not delivered under (a) above,
upon the rejection of this Agreement by or on behalf of the non-bankrupt Party,
upon written request therefor by the other Party.
16.8 OPT OUT BY AMGEN. In the event Amgen shall provide notice of its
election to opt out of this Agreement pursuant to Section 15.2, this Agreement
shall automatically terminate within thirty (30) days after Hyseq's receipt of
such opt-out notice. The effects of such termination will occur in accordance
with Section 16.9(c).
16.9 EFFECTS OF TERMINATION. In addition to any other remedies which may
be available at law or equity, upon termination of this Agreement the rights and
obligations of the Parties shall be as set forth in this Section 16.9.
(a) Upon termination of this Agreement in accordance with either
Sections 16.2, 16.3, 16.6(b) or 16.7(a), the following rights and obligations
shall apply:
(i) The following provisions shall remain in full force and
effect after the expiration or termination of this Agreement: Article 1,
Section 7.1, Subsection 8.3(f), Section 9.1, Subsection 9.2(b),
Subsection 9.2(e) (solely to the extent relevant to the
46.
license granted to Amgen pursuant to Section 9.2(b)), Subsection 9.3(b),
Subsection 9.3(c) (solely to the extent relevant to the license granted
to Amgen pursuant to Section 9.2(b)), Subsection 9.4(a)(i) (solely to
the extent pertaining to Joint Patent Rights); Subsection 9.4(a)(ii)
(with respect to the claims of Joint Patent Rights not relating to
Collaboration Products); Subsection 9.4(b), Subsection 9.4(d) (first
sentence only, with Amgen having the rights of the Commercial Lead);
Subsection 9.6(a)(i) (with Hyseq being included within the definition of
a Third Party and Amgen bearing all costs and expenses and being
entitled to all recoveries from such actions), Subsection 9.6(a)(ii)
(with respect to the claims of Joint Patent Rights not relating to
products which may in any way affect the rights conferred to Amgen to
Develop, manufacture and Commercialize Collaboration Products, with
Hyseq bearing all costs and expenses and being entitled to all
recoveries from such actions); Subsection 9.6(b)(i) (with respect to the
claims of Hyseq Patent Rights not relating to products which may in any
way affect the rights conferred to Amgen to Develop, manufacture and
Commercialize Collaboration Products and with Hyseq bearing all costs
and expenses and being entitled to all recoveries from such actions),
Subsection 9.6(b)(ii) (only with respect to products which may in any
way affect the rights conferred to Amgen to Develop, manufacture and
Commercialize Collaboration Products) and with Amgen bearing all costs
and expenses and being entitled to all recoveries from such actions),
Subsection 9.6(c)(i) (with Amgen having the rights of the Commercial
Lead), Section 9.7 (with Amgen having the rights of the Commercial
Lead), Section 9.8(b)-(d) (except that a Party bringing a suit under
Section 9.6 shall reimburse the other Party for its reasonable costs and
expenses for assisting therewith), Section 9.9, Section 9.11 (solely
with respect to any ongoing possession or exchange of the other Party's
Confidential Information), Section 9.12 (with Amgen having the
obligations of the Commercial Lead); Article 10 (only with respect to
surviving rights and obligations pursuant to this Section 16.9(a) and to
accrued rights and obligations pursuant to Section 16.12), Article 11
(with Amgen having the rights of the Commercial Lead), Article 12,
Section 13.1, Section 13.2(f), Sections 13.3(a)-(b), Section 13.4(a),
Section 13.5, Article 14, Section 16.1, Section 16.9, Section 16.11,
Section 16.12, Article 17 and Article 18.
(ii) Amgen shall have sole and full control, authority and
responsibility for conducting, funding and pursuing all aspects of
Development, manufacture and Commercialization of Collaboration Products
in the Field of Use in the Territory, with no obligation of accounting
to Hyseq.
(iii) Pursuant to Section 4.5, Hyseq shall promptly transfer to
Amgen all right, title and interest in (or comparable rights in) all
Regulatory Filings and Regulatory Approvals then in its name for all
Collaboration Products and shall notify the appropriate Regulatory
Authorities and take any other action reasonably necessary to effect
such transfer of ownership. Hyseq shall assign to Amgen Hyseq's right,
title and interest in the Product Trademarks. At Amgen's request and
expense, within seven (7) days after such request Hyseq will provide
Amgen with access to any pre-clinical and clinical information
(reasonably necessary to the continued Development and Commercialization
of a Collaboration Product), and Hyseq will assist Amgen in
47.
responding to any request or inquiry by a Regulatory Authority regarding
such information.
(iv) Amgen shall have the right to use Hyseq's Trademarks in the
selling of any existing inventory of Collaboration Product(s) (and to
use Promotional Materials it then has on hand, provided however, that
Amgen promptly creates new Promotional Materials which do not use
Hyseq's corporate name and/or logo), with no obligation of accounting to
Hyseq.
(v) Hyseq shall within thirty (30) days (other than with respect
to Third Party agreements entered into pursuant to Section 6.8, in which
case by no later than completion of its obligations, if any, under
Section 16.9(a)(vii) below), at the request of Amgen, assign (if
assignable under its terms) to Amgen all of Hyseq's rights and
obligations under any then-existing Third Party agreements limited
specifically to Collaboration Products, regarding the making, having
made, use, selling, offering to sell, and importing, exporting or
otherwise transferring physical possession of or otherwise transferring
title in or to Collaboration Products and shall not (until receiving
notice of whether or not Amgen desires such an assignment) terminate or
amend any such Third Party agreement. Otherwise, Hyseq shall, at the
request of Amgen, sublicense (if sublicenable under its terms) to Amgen
all of Hyseq's rights and obligations under any then-existing Third
Party agreement regarding the making, having made, use, selling,
offering to sell, and importing, exporting or otherwise transferring
physical possession of or otherwise transferring title in or to
Collaboration Products and shall not (until receiving notice of whether
or not Amgen desires such a sublicense) terminate or amend any such
Third Party agreement. Such assignment or sublicense shall be made for
no additional consideration and be under the same terms and conditions
as the underlying agreement.
(vi) Hyseq shall within thirty (30) days (other than with
respect to Amgen Material and Manufacturing Information, in which case
by no later than completion of its obligations, if any, under Section
16.9(a)(vii) below) destroy, or at Amgen's request return, all of
Amgen's Confidential Information (other than with respect to maintaining
one (1) archival copy of Confidential Information related thereto for
its legal files, for the sole purpose of determining its obligations
under this Agreement) and Materials, and shall provide Amgen with
certification by an officer of Hyseq that all such Confidential
Information and Materials have been destroyed or returned to Amgen, as
appropriate.
(vii) In the event Hyseq shall have been the Manufacturing Lead
at termination and (1) have been using a Third Party contract
manufacturer to manufacture Collaboration Products, it shall only be
obligated, with respect to the manufacture and supply of Collaboration
Products under this Agreement, to assign its agreement with each such
Third Party contract manufacturer to Amgen or (2) have been
manufacturing Collaboration Products at its own facilities, it shall
remain responsible for supplying the amounts of Collaboration Products
that it was obligated to supply at the time of such termination
(consistent with the clinical and/or commercial forecasts, as
applicable, and
48.
other terms and conditions of the Process Development/Manufacturing Plan
section of the Program Plan) for a reasonable period of time to allow
Amgen to obtain an alternate source of supply, if necessary, pursuant to
a transition plan which shall be approved by [***] decision of the
Steering Committee and which shall set forth the responsibilities and
schedules for transferring manufacturing responsibilities as
expeditiously as possible with the goal of providing for an
uninterrupted supply of Collaboration Product of suitable quality and
quantity required for the Development and Commercialization to proceed.
Hyseq shall have the right to charge Amgen and Amgen shall pay Hyseq's
Standard Cost plus [***] for the supply of Collaboration Products
pursuant to this Section 16.9(a)(vii) and shall also reimburse Hyseq for
all Third Party payments made to any Third Party pursuant to Section 6.8
(to the extent such agreements have not already been transferred
pursuant to Section 16.9(a)(v)). Once manufacturing responsibility has
been successfully transferred, Hyseq shall no longer be responsible for
any obligations pursuant to Article 6. In the event Hyseq is obligated
to continue to supply Collaboration Products under this Section
16.9(a)(vii), Amgen shall use Commercially Reasonable Efforts to
identify one or more viable Third Party manufacturers in order to
transfer manufacturing operations as soon as commercially reasonable.
(viii) Amgen hereby agrees to Indemnify the Hyseq Indemnitees
from and against any and all Losses resulting from any Third Party
claims, suits, actions or demands resulting directly or indirectly from
the Development, manufacture or Commercialization of Collaboration
Products (including a claim that a Collaboration Product caused death or
personal injury of any kind). To be eligible to be Indemnified as
described above in this Section 16.9(a)(viii), the Hyseq Indemnitees
shall provide Amgen with prompt notice of any claim (with a description
of the claim and the nature and amount of any such Loss) giving rise to
the indemnification obligation pursuant to this Section 16.9(a)(viii)
and the exclusive ability to defend such claim (with the reasonable
cooperation of Hyseq Indemnitees); provided however, that Amgen shall be
relieved of its obligations only if any failure by the Hyseq Indemnitee
to deliver prompt notice shall have been prejudicial to its ability to
defend such action. Hyseq shall have the right to retain its own
counsel, at its own expense, if representation of the counsel of Amgen
would be inappropriate due to actual or potential differing interests
between the Parties. Neither Party shall settle or consent to the entry
of any judgment with respect to any claim for Loss for which
indemnification is sought, without the prior written consent of the
other Party (not to be unreasonably withheld). Amgen's obligation to
Indemnify the Hyseq Indemnitees pursuant to this Section 16.9(a)(viii)
shall not apply to the extent of any Losses (i) that arise from the
negligence or intentional misconduct of any Hyseq Indemnitee (including
but not limited to that arising from the Development of Collaboration
Product by Hyseq); (ii) that arise from Hyseq's breach of any
representation, warranty, covenant or obligation under this Agreement;
or (iii) for which Hyseq is obligated to Indemnify the Amgen Indemnitees
pursuant to Section 14.2 of this Agreement.
(ix) Except as expressly set forth in this Section 16.9(a), all
other rights and obligations shall terminate.
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(b) Upon termination of this Agreement in accordance with Section 16.5,
the following rights and obligations shall apply:
(i) The following provisions shall remain in full force and
effect after the expiration or termination of this Agreement: Article 1,
Section 7.1, Subsection 8.3(f), Section 9.1, Subsection 9.4(a) (solely
to the extent pertaining to Joint Patent Rights), Subsection 9.4(d)
(with the Commercial Lead and other Party on the date of termination
retaining their respective rights thereunder, unless survival of this
Subsection would have a materially adverse effect on either Party),
Subsection 9.6(a)(i), Subsection 9.6(a)(ii) (solely to the extent
pertaining to Joint Patent Rights), Subsection 9.6(b)(i), Subsection
9.6(c) (with the Commercial Lead and other Party on the date of
termination retaining their respective rights thereunder unless survival
of this Subsection would have a materially adverse effect on either
Party), Subsection 9.6(d) (only with respect to actions pertaining to
Joint Patent Rights under surviving Section 9.6 or brought under
9.6(c)), Section 9.7 (with the Commercial Lead and other Party on the
date of termination retaining their respective rights thereunder),
Subsections 9.8(b)-(d), Section 9.9, Article 10 (only with respect to
surviving rights and obligations pursuant to this Section 16.9(b) and
accrued rights and obligations pursuant to Section 16.12), Article 11
(with the Commercial Lead and other Party on the date of termination
retaining their respective rights thereunder), Article 12, Section 13.1,
Section 13.2(f), Sections 13.3(a)-(b), Section 13.4(a), Section 13.5,
Article 14, Section 16.1, Section 16.9, Section 16.11, Section 16.12,
Article 17 and Article 18.
(ii) Each Party shall within thirty (30) days destroy, or at the
other Party's request return, all of the other Party's Confidential
Information (other than with respect to maintaining one (1) archival
copy of Confidential Information related thereto for its legal files,
for the sole purpose of determining its obligations under this
Agreement) and Materials, and shall provide the other Party with
certification by an officer of such Party that all such Confidential
Information and Materials have been destroyed or returned to the other
Party, as appropriate.
(iii) Except as expressly set forth in this Section 16.9(b), all
other rights and obligations shall terminate
(c) Upon termination of this Agreement under Section 16.4, as a
consequence of an Amgen Default pursuant to Section 16.6(c) or under Section
16.8, and upon entering into the License Agreement attached in Schedule IV
(which, at the request of Hyseq, shall be timely executed by Amgen), in addition
to the rights and obligations of the Parties pursuant to such License Agreement
the following rights and obligations shall apply (provided however if Hyseq
elects not to execute such License Agreement, the rights and obligations of the
Parties shall be governed by the terms and conditions of Section 16.9(b)):
(i) The following provisions shall remain in full force and
effect after the expiration or termination of this Agreement: Article 1,
Subsection 8.3(f), Article 10 (only with respect to surviving rights and
obligations pursuant to this Section 16.9(c)
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and accrued rights and obligations pursuant to Section 16.12), Article
11 (with the Commercial Lead and other Party on the date of termination
retaining their respective rights thereunder), Article 12, Section 13.1,
Section 13.2(f), Sections 13.3(a)-(b), Section 13.4(a) and Section 13.5,
Article 14, Section 16.1, Section 16.9, Section 16.11, Section 16.12,
Article 17 and Article 18.
(ii) Pursuant to Section 4.5, Amgen shall promptly transfer to
Hyseq all right, title and interest in (or comparable rights in) all
Regulatory Filings and Regulatory Approvals then in its name for all
Collaboration Products, and shall notify the appropriate Regulatory
Authorities and take any other action reasonably necessary to effect
such transfer of ownership. Amgen will also deliver to Hyseq all
correspondence between Amgen and Regulatory Authorities relating to all
Regulatory Filings and Regulatory Approvals.
(iii) Hyseq shall have the right to use Amgen's Trademarks in
the selling of existing inventory of Collaboration Product(s) (and to
use Promotional Materials it then has on hand, provided however, that
Hyseq promptly creates new Promotional Materials' which do not use
Amgen's corporate name and/or logo).
(iv) Amgen shall within thirty (30) days (other than with
respect to information necessary or useful to complete its obligations
under Section 16.9(c)(vi) below, in which case by no later than
completion of its obligations, if any, under Section 16.9(c)(vi) below)
destroy, or at Hyseq's request return, all of Hyseq's Confidential
Information (other than with respect to maintaining one (1) archival
copy of Confidential Information related thereto for its legal files,
for the sole purpose of determining its obligations under this
Agreement) and Materials, and shall provide Hyseq with certification by
an officer of Amgen that all such Confidential Information and Materials
have been destroyed or returned to Hyseq, as appropriate.
(v) Amgen shall within thirty (30) days (other than with respect
to Third Party agreements entered into pursuant to Section 6.8, in which
case by no later than completion of its obligations, if any, under
Section 16.9(c)(vi) below), at the request of Hyseq, assign (if
assignable under its terms) to Hyseq all of Amgen's rights and
obligations under any then-existing Third Party licenses having a
license grant limited specifically to Collaboration Products, regarding
the making, having made, use, selling, offering to sell, and importing,
exporting or otherwise transferring physical possession of or otherwise
transferring title in or to Collaboration Products and shall not (until
receiving notice of whether or not Hyseq desires such an assignment)
terminate or amend any such Third Party license. Otherwise, Amgen shall,
at the request of Hyseq, sublicense (if sublicensable under its terms)
to Hyseq all of Amgen's rights and obligations under any then-existing
Third Party licenses regarding the making, having made, use, selling,
offering to sell, and importing, exporting or otherwise transferring
physical possession of or otherwise transferring title in or to
Collaboration Products and shall not (until receiving notice of whether
or not Hyseq desires such a sublicense) terminate or amend any such
Third Party license. Such assignment or sublicense shall
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be made for no additional consideration and be under the same terms and
conditions as the underlying agreement.
(vi) In the event Amgen shall have been the Manufacturing Lead
at termination and had been manufacturing Collaboration Products at its
own facilities, it shall remain responsible for supplying the amounts of
Collaboration Products that it was obligated to supply at the time of
such termination (consistent with the clinical and/or commercial
forecasts, as applicable, and other terms and conditions of the Process
Development/Manufacturing Plan section of the Program Plan) for a
reasonable period of time to allow Hyseq itself manufacture or to obtain
an alternate source of supply, if necessary, pursuant to a transition
plan which shall be consistent with Section 6.7 and approved by [***]
decision of the Steering Committee and which shall set forth the
responsibilities and schedules for transferring manufacturing
responsibilities as expeditiously as possible with the goal of providing
for an uninterrupted supply of Collaboration Product of suitable quality
and quantity required for the Development and Commercialization to
proceed. Amgen shall have the right to charge Hyseq and Hyseq shall pay
Amgen's Standard Cost plus [***] for the supply of Collaboration
Products pursuant to this Section 16.9(c)(vi) and shall also reimburse
Amgen for all Third Party payments made to any Third Party pursuant to
Section 6.8 (to the extent such agreements have not already been
transferred pursuant to Section 16.9(c)(v)). Once manufacturing
responsibility has been successfully transferred, Amgen shall no longer
be responsible for any obligations pursuant to Article 6. In the event
Amgen is obligated to continue to supply Collaboration Products under
this Section 16.9(c)(vi), Hyseq shall use Commercially Reasonable
Efforts to identify one or more viable Third Party manufacturers to
which it may transfer manufacturing operations as soon as commercially
reasonable.
(vii) Except as expressly set forth in this Section 16.9(c), all
other rights and obligations shall terminate.
16.10 ACQUISITION. In the event that, during the term of this Agreement,
a Third Party shall acquire, directly or indirectly, more than 50% of the shares
of a Party's stock entitled to vote for the election of directors of such Party
(the "Acquired Party"), the other Party shall have the right, within one hundred
twenty (120) days of such acquisition, to assume the rights and responsibilities
of, and shall be deemed, the Development Lead, Regulatory Lead, Manufacturing
Lead and Commercial Lead (with the Acquired Party being designated as the
"Co-Detailer") and the Acquired Party shall take all actions to facilitate such
transition to the other Party, including without limitation, those as set forth
hereinbelow; provided however, that all other rights and obligations of the
Parties shall remain in full force and effect:
(a) The Acquired Party shall transfer to the other Party ownership of
all Regulatory Filings and Regulatory Approvals then in its name for all
Collaboration Products and shall notify the appropriate Regulatory Authorities
and take any other action reasonably necessary to effect such transfer of
ownership. The Acquired Party shall assign to the other Party all of the
Acquired Party's right, title and interest in the Product Trademarks.
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(b) The Acquired Party shall, at the request of the other Party, assign
(if assignable under its terms) to the other Party all of the Acquired Party's
rights and obligations under any then-existing Third Party licenses having a
license grant limited specifically to Collaboration Products, regarding the
making, having made, use, selling, offering to sell, and importing, exporting or
otherwise transferring physical possession of or otherwise transferring title in
or to Collaboration Products and shall not (until receiving notice of whether or
not the other Party desires such an assignment) terminate or amend any such
Third Party license. Otherwise, the Acquired Party shall, at the request of the
other Party, sublicense (if sublicensable under its terms) to the other Party
all of the Acquired Party's rights and obligations under any then-existing Third
Party licenses regarding the making, having made, use, selling, offering to
sell, and importing, exporting or otherwise transferring physical possession of
or otherwise transferring title in or to Collaboration Products and shall not
(until receiving notice of whether or not the other Party desires such a
sublicense) terminate or amend any such Third Party license.
(c) In the event the Acquired Party shall have been the Manufacturing
Lead on the date of acquisition and (1) have been using a Third Party contract
manufacturer to manufacture Collaboration Products, it shall only be obligated,
with respect to the manufacture and supply of Collaboration Products under this
Agreement, to assign its agreement with each such Third Party contract
manufacturer to the other Party or (2) have been manufacturing Collaboration
Products at its own facilities, it shall remain responsible for supplying the
amounts of Collaboration Products that it was obligated to supply at the time of
such termination (consistent with the clinical and/or commercial forecasts, as
applicable, and other terms and conditions of the Process
Development/Manufacturing Plan section of the Program Plan) for a reasonable
period of time to allow the other Party to obtain an alternate source of supply,
if necessary, pursuant to a transition plan which shall be approved by [***]
decision of the Steering Committee and which sets forth responsibilities and
schedules for transferring manufacturing responsibilities as expeditiously as
possible with the goal of providing for an uninterrupted supply of Collaboration
Product of suitable quality and quantity required for the Development and
Commercialization to proceed. Once manufacturing responsibility has been
successfully transferred, the Acquired Party shall no longer be responsible for
the manufacture and supply of Collaboration Products to the other Party for the
Development and Commercialization of Collaboration Products in the Territory and
making any decision with respect thereto and shall no longer be responsible for
any process development work to support quality assurance, improving
manufacturing/cost efficiency and commercial scale-up manufacturing. In the
event the Acquired Party is obligated to continue to supply Collaboration
Products under this Section 16.10(c), the other Party shall use Commercially
Reasonable Efforts to identify one or more viable Third Party manufacturers in
order to transfer manufacturing operations as soon as commercially reasonable.
16.11 TRANSITION. After a notice of termination has been delivered
pursuant to any one of Sections 16.2 to 16.8, each Party shall, in no event in
excess of ninety (90) days after the delivery date of such notice (other than
with respect to obligations which explicitly exceed such 90-day period), assist
(and, other than Wind Down Costs, be responsible for its own costs and expenses)
in the transition of affairs as set forth in this Article 16 in a timely,
reasonable and businesslike manner. Such assistance shall include, but not be
limited to (i) making its personnel and other resources reasonably available to
the other Party, as necessary and (ii) transferring
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copies of all relevant information, files or data containing Information and all
Materials to the non-terminating Party. Thereafter, unless explicitly set forth
in Sections 16.2 through 16.9, as appropriate, the Parties shall have no further
obligation to assist in such transition.
16.12 ACCRUED RIGHTS. Termination, relinquishment or expiration of any
licenses under this Agreement or of this Agreement for any reason in accordance
with this Article 16 shall be without prejudice to any rights which shall have
accrued to the benefit of either Party or any liability incurred by either Party
prior to the effective date of such termination, relinquishment or expiration
and shall not preclude either Party from pursuing all rights and remedies it may
have hereunder or at law or in equity with respect to any breach of this
Agreement nor prejudice either Party's right to obtain performance of any
obligation.
ARTICLE 17
DISPUTE RESOLUTION
17.1 DISPUTES. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to
either Party's rights and/or obligations hereunder and which are not resolved by
the Steering Committee (e.g. disputes pursuant to Section 2.4(b)(v)). It is the
objective of the Parties to establish procedures to facilitate the resolution of
disputes arising from, concerning or in any way relating to this Agreement in an
expedient manner by mutual cooperation and without resort to litigation. To
accomplish this objective, the Parties agree to follow the procedures set forth
in this Section 17.1 if and when such a dispute arises under this Agreement
(other than with respect to disputes to be resolved in accordance with Section
2.4(b)(i)-(iv) or, as set forth in this Agreement, disputes explicitly excluded
from being resolved pursuant to this Article 17). The Parties shall undertake
good faith efforts to resolve any such dispute in good faith. In the event the
Parties shall be unable to resolve such dispute, either Party may, by written
notice to the other Party, have any dispute between the Parties referred to
their respective executive officers designated below (or their designees or
successors), for attempted resolution by good faith negotiations within fifteen
(15) days after such notice is received. Such designated officers are as
follows:
For Hyseq: Hyseq's General Counsel
For Amgen: Amgen's General Counsel
If the designated officers are not able to resolve such dispute within such
fifteen (15) day period, the dispute will be referred to the respective Chief
Executive Officers of each Party, or their Senior Vice President designee(s). If
the Chief Executive Officers (or their designees) are unable to resolve such
dispute within such further 15-day period, either Party may at any time
thereafter pursue any legal or equitable remedy available to it. Notwithstanding
the above, either Party shall be entitled at all times and without delay to seek
equitable relief.
17.2 GOVERNING LAW; JUDICIAL RESOLUTION. Resolution of all disputes
arising out of or related to this Agreement or the performance, enforcement,
breach or termination of this Agreement and any remedies relating thereto, shall
be governed by and construed under the
54.
substantive laws of the State of California, as applied to agreements executed
and performed entirely in the State of California by residents of the State of
California, without regard to conflicts of law rules. Any dispute arising under
this Agreement shall be submitted to a state or federal court of competent
jurisdiction in California; provided however, that if Amgen is the initiating
Party in a dispute, its shall bring such suit in a state or federal court which
has jurisdiction over Sunnyvale, California; and if Hyseq is the initiating
Party in a dispute, its shall bring such suit in a state or federal court which
has jurisdiction over Thousand Oaks, California.
17.3 PATENT AND TRADEMARK DISPUTE RESOLUTION. Notwithstanding the above
Section 17.2, as between the Parties, any dispute, controversy or claim relating
to the scope, validity, enforceability or infringement of any Collaboration
Patent Rights or of any Amgen Trademark, Hyseq Trademark or Product Trademark
shall be submitted to a court of competent jurisdiction in the Territory in
which such patent or trademark rights were granted or arose. Notwithstanding the
foregoing, any dispute, controversy or claim relating to the scope, validity,
enforceability or infringement of any United States patent application or patent
within Collaboration Patent Rights shall be submitted to a court of competent
jurisdiction in the State of California.
ARTICLE 18
GENERAL
18.1 CONDITIONS TO CLOSING. The obligations of each Party to the other
Party under this Agreement are subject to fulfillment, on or before the
Effective Date, of the execution and delivery of the Warrant Purchase Agreement.
18.2 FORCE MAJEURE. Both Parties shall be excused from the performance
of their obligations under this Agreement to the extent that such performance is
prevented by Force Majeure and the nonperforming Party promptly provides notice
of the prevention to the other Party. Such excuse shall be continued so long as
the condition constituting Force Majeure continues and the nonperforming Party
uses reasonable efforts to remove the condition. When such circumstances arise,
the Parties shall discuss what, if any, modification of the terms of this
Agreement may be required in order to arrive at an equitable solution.
18.3 NOTICES. Any notice required or permitted to be given under this
Agreement shall be in writing, shall specifically refer to this Agreement and
shall be deemed to have been sufficiently given for all purposes if mailed by
first class certified or registered mail, postage prepaid, express delivery
service or personally delivered, or if sent by facsimile, electronic
transmission confirmed. Unless otherwise notified in writing, the mailing
addresses and fax numbers for notice of the Parties shall be as described below.
For Hyseq: Hyseq Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇.
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attn: General Counsel
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With a copy to: Chief Financial Officer
For Amgen: Amgen Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Vice President, Licensing
With a copy to: Corporate Secretary
18.4 MAINTENANCE OF RECORDS. Each Party shall keep and maintain all
records required by law or regulation with respect to Collaboration Products and
shall make copies of such records available to the other Party upon request.
18.5 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly
and shall not be strictly construed against either Party.
18.6 PERFORMANCE BY AFFILIATES. Each of Amgen and Hyseq acknowledge that
obligations under this Agreement may be performed by Affiliates of Amgen and
Hyseq and that each of Amgen and Hyseq may grant its respective Affiliates a
license or sublicense to (or covenant not to ▇▇▇ under) Amgen Technology, Hyseq
Technology, Joint Know-How, Joint Patent Rights, Amgen Trademarks, Hyseq
Trademarks and Product Trademarks, as applicable, only to the extent and only
for so long as such license or sublicense or covenant not to ▇▇▇ is necessary
for such Affiliate to perform such tasks. Each of Amgen and Hyseq guarantee
performance of this Agreement by its Affiliates, notwithstanding any assignment
to Affiliates in accordance with Section 18.8 below. Wherever in this Agreement
the Parties delegate responsibility to Affiliates or local operating entities,
the Parties agree that such entities may neither make decisions inconsistent
with this Agreement, amend the terms of this Agreement nor act contrary to its
terms in any way. The Party granting a license or sublicense to its Affiliates
shall forward to the other Party a copy of each fully executed license or
sublicense agreement, within [***] of the execution of each such license or
sublicense agreement.
18.7 SUBCONTRACTING. The Parties acknowledge and agree that the
following portions of the work involved in Development, manufacture and
Commercialization of Collaboration Products may be subcontracted to a Third
Party by the responsible Party, and the Party entering into such subcontract may
as part of such subcontract grant to such Third Party a license or sublicense to
Amgen Technology, Hyseq Technology, Joint Know-How, Joint Patent Rights, Amgen
Trademarks, Hyseq Trademarks and Product Trademarks, as applicable, only to the
extent and only for so long as such license or sublicense is necessary for such
Third Party to perform such tasks; provided however, that the responsible Party
remains responsible for the satisfactory accomplishment of such work in
accordance with the terms and conditions of this Agreement and that the
subcontractor shall enter into a written agreement binding such subcontractor to
the obligations the responsible Party has to the other Party (and containing any
other provisions normal and customary for similar types of agreements): (i) the
Development Lead may contract with/establish clinical sites, investigators and
CROs pursuant to Section 3.2; (ii) the Parties may subcontract to a Third Party
manufacturer pursuant to Section 6.7; and (iii)
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the Commercialization Lead may, in its sole discretion, decide to unilaterally
enter into agreements with distributors or sublicensees for commercial
distribution of Collaboration Products; (provided however, that any proceeds
from a sublicense activity shall be credited to the Operating Profit or Loss
account). The subcontracting Party shall Commercially Reasonable Efforts to
enter into an Agreement with the bidder that is best able to meet the Parties'
mutual requirements, taking into consideration such factors as price, quality,
capacity, quantity, reliability and reputation. The subcontracting Party shall
forward to the other Party a copy of each fully executed subcontracting
agreement, within [***]of the execution of each such agreement.
18.8 ASSIGNMENT. Except as set forth in Sections 18.6 and 18.7, neither
Party may assign or transfer this Agreement or any rights or obligations
hereunder without the prior written consent of the other, except that a Party
may make such an assignment without the other Party's consent to Affiliates or
to an entity that acquires all or substantially all of the business of such
Party, whether in a merger, consolidation, reorganization, acquisition, sale or
otherwise. This Agreement shall be binding on the successors and assigns of the
assigning Party, and the name of a Party appearing herein shall be deemed to
include the name(s) of such Party's successors and permitted assigns to the
extent necessary to carry out the intent of this Agreement. Any assignment or
attempted assignment by either Party in violation of the terms of this Section
18.8 shall be null and void and of no legal effect. The assigning Party shall
forward to the other Party a copy of those portions of each fully executed
assignment agreement which relate to the assumption of the rights and
responsibilities of the assigning Party, within [***] of the execution of such
assignment agreement.
18.9 COUNTERPARTS. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
18.10 SEVERABILITY. If any one or more of the provisions of this
Agreement are held to be invalid or unenforceable by any court of competent
jurisdiction from which no appeal can be or is taken, the provision shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof. The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement, as evidenced by the terms of this Agreement in accordance with
Section 18.19, may be realized.
18.11 HEADINGS. The headings for each Article and Section in this
Agreement have been inserted for convenience of reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular Article or Section. Unless otherwise specified, (a) references in
this Agreement to any Article, Section, Exhibit or Schedule shall mean
references to such Article, Section, Exhibit or Schedule of this Agreement, (b)
references in any Section to any clause are references to such clause of such
Section, and (c) references to any agreement, instrument or other document in
this Agreement refer to such agreement, instrument or other document as
originally executed or, if subsequently varied, replaced or
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supplemented from time-to-time, as so varied, replaced or supplemented and in
effect at the relevant time of reference thereto.
18.12 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of the
Agreement.
18.13 INDEPENDENT CONTRACTORS. The relationship between Hyseq and Amgen
created by this Agreement is solely that of independent contractors. This
Agreement does not create any agency, distributorship, employee-employer,
partnership, joint venture or similar business relationship between the Parties.
Neither Party is a legal representative of the other Party, and neither Party
can assume or create any obligation, representation, warranty or guarantee,
express or implied, on behalf of the other Party for any purpose whatsoever.
Each Party shall use its own discretion and shall have complete and
authoritative control over its employees and the details of performing its
obligations under this Agreement.
18.14 NO BENEFIT OF THIRD PARTIES. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties hereto and their successors and permitted assigns, and they shall
not be construed as conferring any rights on any Third Parties.
18.15 USE OF NAMES, LOGOS OR SYMBOLS. Subject to Sections 5.5, 12.2(a)
and 12.4, no Party hereto shall use, and no rights are granted in or to, the
names or trademarks (including the names "Amgen" and "Hyseq"), physical
likeness, employee names or owner symbol of any other Party for any purpose
(including, without limitation, private or public securities placements) without
the prior written consent of the affected Party, such consent not to be
unreasonably withheld or delayed so long as such use of name is limited to
objective statement of fact rather than for endorsement purposes. Neither Party
shall use any trademark which either substantially resembles or is confusingly
similar to, misleading or deceptive with respect to, or which dilutes any of the
other Party's trademarks in connection with the subject matter of this
Agreement.
18.16 NO WAIVER. Any delay in enforcing a Party's rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of such Party's rights to the future enforcement of its
rights under this Agreement, except with respect to an express written and
signed waiver relating to a particular matter for a particular period of time.
18.17 OFFSET. Either Party shall be entitled to offset, against any
payments due and payable to the other Party hereunder, all such amounts due and
payable hereunder but not yet paid by the other Party to the Party seeking such
offset. Prior to applying an offset under this Section 18.17, the Party seeking
such offset shall first give the other Party written notice of such due and
payable amounts and shall request the other Party to pay all such due and
payable amounts within [***] from the date of such notice.
18.18 EXPORT REQUIREMENTS. It is understood and acknowledged that the
transfer of certain commodities and technical data is subject to United States
laws and regulations controlling the export of such commodities and technical
data, including all Export
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Administration Regulations of the United States Department of Commerce. Each
Party hereby agrees and by entering into this Agreement gives written assurance
that it shall comply with all United States laws and regulations controlling the
export of commodities and technical data within Information and Materials, that
it will be solely responsible for any violation of any such laws and regulations
by itself, its Affiliates or its sublicensees, and that it will Indemnify,
defend and hold the other Party harmless from any liability in the event of any
legal action of any nature occasioned by such violation, pursuant to Section
14.1 (in the case of Amgen) or Section 14.2 (in the case of Hyseq).
18.19 ENTIRE AGREEMENT; AMENDMENT. This Agreement (including all
Exhibits and Schedules, including the Warrant Purchase Agreement) set forth the
complete, final and exclusive agreement and all the covenants, promises,
agreements, warranties, representations, conditions and understandings between
the Parties hereto and supersedes and terminates all prior agreements and
understandings between the Parties; on the Effective Date of this Agreement, the
Confidential Disclosure Agreement dated October 10, 2001 (Amgen Reference No.
20018121) is hereby superseded, provided that all Confidential Information
disclosed therein shall be treated as if disclosed under, and shall be subject
to the terms of, this Agreement. There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties other than as are set forth herein and therein.
This Agreement may only be modified or supplemented in a writing expressly
stated for such purpose and signed by an authorized officer of each Party (i.e.,
it may not be modified by any purchase order, change order, acknowledgment,
order acceptance, standard terms of sale, invoice or the like); except that the
Steering Committee may amend or update the Program Plan as expressly permitted
hereby.
18.20 EXHIBITS AND SCHEDULES. All Exhibits and Schedules referenced
herein and attached hereto are incorporated in this Agreement by reference. In
case of any discrepancies between the language incorporated from the Exhibits
and Schedules and the terms of the Sections, the terms of the Sections shall
prevail; provided however, where Sections of the Agreement make explicit
reference to a substantive matter contained in an Exhibit or Schedule, or with
respect to definitions set forth in the Exhibits or Schedules, the substantive
matter or definitions contained in such Exhibit and Schedules shall prevail.
59.
IN WITNESS WHEREOF, the Parties have executed this Agreement in
duplicate originals by their duly authorized representatives as of the Effective
Date.
AMGEN INC. HYSEQ, INC.
(D.B.A. HYSEQ PHARMACEUTICALS)
By: By:
-------------------------------- --------------------------------
Print Name: Print Name:
------------------------ ------------------------
Title: Title:
----------------------------- -----------------------------
60.
EXHIBIT A
DEFINED TERMS
A.1 "AFFILIATE" shall mean, except as provided below, an individual, a
partnership, a joint venture, a corporation, a trust, an estate, an
unincorporated organization, a government or any department or agency thereof,
or any other entity or any combination of the aforementioned entities that,
directly or indirectly through one or more intermediaries, controls, is
controlled by or is under common control with Amgen or Hyseq. For purposes of
this definition, "control" shall mean the possession, direct or indirect, of the
power to cause the direction of the management and policies of a Party, whether
through ownership of more than fifty percent (50%) of the voting securities of
such Party, by contract or otherwise.
A.2 "ALFIMEPRASE" shall mean the polypeptide having the amino acid
sequence which is set forth in Exhibit B.
A.3 "AMGEN KNOW-HOW" shall mean all Information and Material Controlled
by Amgen on or following the Effective Date necessary to Develop, manufacture or
Commercialize Collaboration Products, including but not limited to the following
information: (1) information disclosed in the IND for Alfimeprase as of the
Effective Date; (2) information disclosed as of the Effective Date in any IND
supplements for Alfimeprase; (3) all Amgen-sponsored collaborator data and
results (subject to any contractual confidentiality obligations of Amgen to
Third Parties regarding such results); (4) any regulatory data which Amgen
provides to Hyseq; (5) sequence information of other Collaboration Products and
information regarding their activity; and (6) such information which Amgen
expressly designates in writing it intends to include as Amgen Know-How under
this Agreement; provided however, that Amgen Know-How shall exclude Amgen
Material and Manufacturing Information.
A.4 "AMGEN MATERIAL AND MANUFACTURING INFORMATION" shall mean the most
current version of (i) the Materials (other than Collaboration Products); (ii)
the Information pertaining to the manufacture of Collaboration Products
including, without limitation, Information contained in the CMC section of any
applicable Regulatory Filings or Information regarding Amgen's manufacturing
facility; and (iii) Information regarding the Materials.
A.5 "AMGEN PATENT RIGHTS" shall mean Amgen's rights in (a) those Patent
Rights Controlled by Amgen on the Effective Date with respect to the
Collaboration Products and listed in Exhibit D and (b) all Patent Rights
Controlled by Amgen prior to or during the Agreement that claim Amgen Know-How.
A.6 "AMGEN TECHNOLOGY" shall mean all Amgen Patent Rights and Amgen
Know-How and Amgen's interest in the Joint Patent Rights and Joint Know-How.
A.7 "AMGEN TRADEMARKS" shall mean, other than Product Trademarks, any
and all corporate names, service marks, logos or trademarks and trademark
applications (whether or not registered) together with all good will associated
therewith, and any renewals, extensions or modifications thereto either filed or
used by Amgen.
A-1
A.8 "CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on either March 31, June 30, September 30, or
December 31 for so long as this License Agreement is in effect.
A.9 "CALENDAR YEAR" means each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
A.10 "CMC" shall mean the Chemistry Manufacturing Control section of a
Regulatory Filing.
A.11 "COLLABORATION PATENT RIGHTS" shall mean Amgen Patent Rights, Hyseq
Patent Rights and Joint Patent Rights.
A.12 "COLLABORATION PRODUCT(S)" shall mean (a) Alfimeprase or (b) any
fibrinolytic metalloproteinase product which is owned or Controlled by Amgen
and/or Hyseq and which has, incorporates, or contains the following properties:
(i) is [***], (ii) does not require the involvement of the [***], and (iii) is
complexed by [***].
A.13 "COMMERCIAL EXPENDITURES" shall have the meaning set forth in
Schedule I.
A.14 "COMMERCIAL PLAN" shall mean the comprehensive plan and overall
strategy, and any updates thereto, for the Commercialization of Collaboration
Products (in accordance with customary standards for a product of comparable
market potential) including, without limitation, regulatory activities after the
Transition Date, Promotion, Detailing and other pre-launch and post-launch
marketing and sales activities. The Commercial Plan shall include, but not be
limited to, a reasonably detailed description of the schedule of work
activities, responsibility for the work activities and an associated budget.
A.15 "COMMERCIALIZE" OR "COMMERCIALIZATION" shall mean all activities
after the Transition Date, or prior to the Transition Date upon the approval of
both Parties, (including the preparation and filing of Drug Approval
Applications) of a Collaboration Product relating to the Promotion, Detailing,
and other pre-launch and post-launch marketing and sale activities and shall
include, without limitation, Post-Approval Clinical Studies and regulatory
affairs related to the foregoing.
A.16 "COMMERCIALLY REASONABLE EFFORTS" shall mean the level of efforts
and resources required to Develop, manufacture or Commercialize a Collaboration
Product in a sustained manner consistent with the efforts a similarly situated
biopharmaceutical company would typically devote to a product of similar market
potential, profit potential or strategic value resulting from its own research
efforts, based on conditions then prevailing. Commercially Reasonable Efforts
shall be determined on a country-by-country (each country including its
territories) basis for a particular Collaboration Product, and it is anticipated
that the level of effort will change over time reflecting changes in the status
of the Collaboration Product and the country (including its territories)
involved.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
A-2
A.17 "COMPETITIVE PRODUCT" shall mean any pharmaceutical product, other
than a Collaboration Product, that contains (a) Alfimeprase or (b) any
fibrinolytic metalloproteinase product which has, incorporates, or contains the
following properties: (i) is [***], (ii) does not require the involvement of the
[***], and (iii) is complexed by [***].
A.18 "CONFIDENTIAL INFORMATION" shall mean all Information received by
either Party from the other Party pursuant to this Agreement, other than that
portion of such Information which:
(a) is publicly disclosed by the disclosing Party, either before or
after it becomes known to the receiving Party;
(b) was known to the receiving Party, without obligation to keep it
confidential, prior to when it was received from the disclosing
Party;
(c) is subsequently disclosed to the receiving Party by a Third
Party lawfully in possession thereof without obligation to keep
it confidential;
(d) has been publicly disclosed other than by the disclosing Party
and without breach of an obligation of confidentiality with
respect thereto; or
(e) has been independently developed by the receiving Party without
the aid, application or use of Confidential Information, as
demonstrated by competent written proof.
A.19 "CONTROL" OR "CONTROLLED" shall mean possession of the ability to
grant a license or sublicense as provided for herein under such intellectual
property right without violating the terms of any agreement or other arrangement
with any Third Party.
A.20 "DETAIL" OR "DETAILING" shall mean, with respect to a Collaboration
Product, an interactive face-to-face visit by a Party's sales representative
with a physician, designated by the Commercial Lead as a member of the target
call audience, at his or her office, at hospitals or at other locations
(excluding exhibits, displays and other forms of communication not involving
face-to-face contact by such sales representative), during which indicated uses,
safety, effectiveness, contraindications, side effects, warnings and/or other
relevant characteristics of a Collaboration Product as approved by a Regulatory
Authority are described in a fair and balanced manner consistent with the FD&C
Act (or equivalent laws in the Territory), as applicable, including, but not
limited to, the regulations at 21 CFR Part 202 and using, as necessary or
desirable, the Product Labeling (as defined herein) or the Promotional Materials
(as defined herein), in an effort to increase physician prescribing preferences
of such Collaboration Product for its approved indicated uses.
A.21 "DEVELOPMENT" OR "DEVELOP" shall mean all research, pre-clinical
and clinical activities undertaken for a Collaboration Product required to
successfully complete Pivotal Trials in an indication in the Territory. For the
avoidance of doubt, these activities shall include
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
A-3
clinical drug development activities, including among other things: test method
development and stability testing, toxicology, formulation, statistical analysis
and report writing, product approval and registration, and regulatory affairs
related to the foregoing. When used as a verb, "Develop" means to engage in
Development.
A.22 "DEVELOPMENT PLAN" shall mean the comprehensive plan, overall
strategy and timelines, and any updates thereto, for the Development of
Collaboration Products (in accordance with customary standards for a product of
comparable market potential) including, without limitation, the research,
preclinical research, clinical studies, development/manufacturing, clinical and
regulatory activities required to obtain Regulatory Approval(s) in the
Territory. The Development Plan shall include, but not be limited to, a
reasonably detailed description of the schedule of work activities,
responsibility for the work activities and an associated budget.
A.23 "DOLLAR" shall mean a United States dollar, and "$" shall be
interpreted accordingly.
A.24 "DRUG APPROVAL APPLICATION" shall mean an application for
Regulatory Approval required before commercial sale or use of a Collaboration
Product as a drug or to treat a particular indication in a regulatory
jurisdiction, including without limitation: (a) (i) a Biologics License
Application (BLA) pursuant to 21 C.F.R. 601.2, submitted to the FDA or any
successor application or procedure and (ii) any counterpart of a U.S. BLA in
another country in the Territory; and (b) all supplements and amendments,
including supplemental Biologics License Applications (and any foreign
counterparts) that may be filed (e.g., to expand the label) with respect to the
foregoing.
A.25 "FDA" shall mean the United States Food and Drug Administration, or
any successor thereto.
A.26 "FIELD OF USE" shall mean all uses of Collaboration Products
including, without limitation, all human therapeutic, prophylactic and
diagnostic uses.
A.27 "FIRST COMMERCIAL SALE" shall mean the initial transfer by a Party
of a Collaboration Product to a Third Party in exchange for cash or some
equivalent to which value can be assigned for the purpose of determining Net
Sales, following Regulatory Approval to market such Collaboration Product.
A.28 "FORCE MAJEURE" shall mean any occurrence beyond the reasonable
control of a Party that prevents or substantially interferes with the
performance by the Party of any of its obligations hereunder, if such occurs by
reason of any act of God, flood, fire, explosion, earthquake, breakdown of
plant, shortage of critical equipment, loss or unavailability of manufacturing
facilities or material, strike, lockout, labor dispute, casualty or accident, or
war, revolution, civil commotion, acts of public enemies, blockage or embargo,
or any injunction, law, order, proclamation, regulation, ordinance, demand or
requirement of any government or of any subdivision, authority or representative
of any such government, inability to procure or use
A-4
materials, labor, equipment, transportation or energy sufficient to meet
manufacturing needs without the necessity of allocation, or any other cause
whatsoever, whether similar or dissimilar to those above enumerated, beyond the
reasonable control of such Party, if and only if the Party affected shall have
used reasonable efforts to avoid such occurrence and to remedy it promptly if it
shall have occurred.
A.29 "GAAP" shall mean United States generally accepted accounting
principles.
A.30 "HYSEQ KNOW-HOW" shall mean all Information and Materials
Controlled by Hyseq on or following the Effective Date necessary to Develop,
manufacture or Commercialize Collaboration Products and any replication or any
part of such Information or Materials.
A.31 "HYSEQ PATENT RIGHTS" shall mean Hyseq's rights in all Patent
Rights that claim Hyseq Know-How and that are Controlled by Hyseq on the
Effective Date or during the Agreement.
A.32 "HYSEQ TECHNOLOGY" shall mean all Hyseq Patent Rights and Hyseq
Know-How and Hyseq's interest in the Joint Patent Rights and Joint Know-How.
A.33 "HYSEQ TRADEMARKS" shall mean, other than Product Trademarks, any
and all corporate names, service marks, logos or trademarks and trademark
applications (whether or not registered) together with all good will associated
therewith, and any renewals, extensions or modifications thereto either filed or
used by Hyseq.
A.34 "IND" shall mean an Investigational New Drug application.
A.35 "INFORMATION" shall mean all tangible and intangible techniques,
technology, practices, trade secrets, inventions (whether patentable or not),
methods, knowledge, know-how, conclusions, skill, experience, test data and
results (including pharmacological, toxicological and clinical test data and
results), analytical and quality control data, results or descriptions, software
and algorithms.
A.36 "JOINT KNOW-HOW" shall mean Information and Materials
characterized, conceived, developed, derived, generated or identified jointly by
employees of or consultants to Hyseq and employees of or consultants to Amgen
from the Effective Date through the Term.
A.37 "JOINT PATENT RIGHTS" shall mean all Patent Rights that claim or
disclose Joint Know-How.
A.38 "LOSSES" shall liabilities, costs, fees, expenses and/or losses,
including without limitation reasonable legal costs, expenses and attorneys'
fees for outside counsel.
A.39 "MAJOR MARKET COUNTRY" shall mean the United States, United
Kingdom, Italy, Germany, France or Japan.
A-5
A.40 "MATERIALS" shall mean certain biological materials including, but
not limited to, Collaboration Products, screens, animal models, cell lines,
cells, nucleic acids, receptors and reagents.
A.41 "NET SALES" shall mean all revenues recognized in accordance with
GAAP from the sale or other disposition of Collaboration Products by Amgen,
Hyseq or their respective Affiliates to a Third Party after deducting returns
and allowances (actually paid or allowed) including, but not limited to, prompt
payment and volume discounts, price reductions, including Medicaid and similar
types of rebates, chargebacks from wholesalers of Collaboration Products
(whether in cash or trade), freight, shipping, packing, insurance, rebates, and
sales and other taxes based on sales prices when included in gross sales, but
not including taxes when assessed on income derived from such sales. Amounts
received by Hyseq or its Affiliates for the sale of Collaboration Products among
Hyseq or its Affiliates for resale shall not be included in the computation of
Net Sales hereunder.
A.42 "OPERATING PROFIT OR LOSS" shall mean, for any period, the total
Net Sales of Collaboration Products less the sum of Collaboration Expenditures.
A.43 "PATENT RIGHTS" shall mean (i) a pending application for a patent,
including without limitation any provisional, converted provisional, continued
prosecution application, continuation, divisional or continuation-in-part
thereof; or (ii) an issued, unexpired patent (with the term "patent" being
deemed to encompass, without limitation, an inventor's certificate) which has
not been held invalid or unenforceable by a court of competent jurisdiction from
which no appeal can be taken or has been taken within the required time period,
including without limitation any substitution, extension, registration,
confirmation, reissue, re-examination, renewal or any like filing thereof.
A.44 "PHASE II CLINICAL TRIAL(S)" shall mean those clinical trials on
sufficient numbers of patients that are designed to establish the safety and
preliminary efficacy of a drug for its intended use, and to define warnings,
precautions and adverse reactions that are associated with the drug in the
dosage range to be prescribed and that satisfy the requirements of 21 CFR
312.21(b) (or its successor regulation), or an equivalent foreign clinical
trial.
A.45 "PHASE IV CLINICAL TRIAL(S)" shall mean those clinical trials,
including safety surveillance studies, conducted under an IND which are agreed
upon by the Commercial Lead and a Regulatory Authority as a condition of
approval or maintenance of approval of a Drug Approval Application for a
Collaboration Product, as the case may be, other than patient registries of
other than a passive, non-interventional nature.
A.46 "PIVOTAL TRIAL(S)" shall mean those clinical trials on sufficient
numbers of patients that, if the defined end-points are met, are designed (and
agreed to by the FDA, or other Regulatory Authorities in the Territory) based
upon existing data in the same patient population as of the start of the trial
to definitively establish that a drug is safe and efficacious for its intended
use, and to define warnings, precautions and adverse reactions that are
associated with the drug in the dosage range to be prescribed, and which provide
pivotal data supporting
A-6
Regulatory Approval of such drug or label expansion of such drug and that
satisfy the requirements of 21 CFR 321.21(c), or its successor regulation, or an
equivalent foreign clinical trial.
A.47 "POST-APPROVAL CLINICAL STUDIES" shall mean those clinical studies,
after Regulatory Approval of a Collaboration Product, approved by the Steering
Committee including, but not limited to, Phase IV Clinical Trials,
pharmacoeconomic studies, pharmacoepidemiology studies, and investigator
sponsored clinical studies and, to the extent requested or modified from time to
time, safety surveillance studies.
A.48 "PROCESS DEVELOPMENT/MANUFACTURING PLAN" shall mean the
comprehensive plan and overall strategy, and any updates thereto, for process
development/manufacturing scale-up, manufacture, formulation, filling and/or
shipping of selected Collaboration Products (in accordance with customary
standards for a product of comparable market potential). The Process
Development/Manufacturing Plan shall include, but not be limited to, (i) a
reasonably detailed description of the schedule of work activities,
responsibility for the work activities and an associated budget of Collaboration
Products prior to completion of any Pivotal Trial therewith and (ii) a
reasonably detailed description of the schedule of work activities,
responsibility for the work activities and an associated budget of Collaboration
Products upon or after completion of any Pivotal Trial therewith.
A.49 "PRODUCT LABELING" shall mean (a) the Regulatory Authority-approved
full prescribing information of a Collaboration Product, including any required
patient information and (b) all labels and other written, printed or graphic
matter upon any container, wrapper or any package insert or outsert utilized
with or for a Collaboration Product.
A.50 "PRODUCT TRADEMARK" shall mean any trademarks and trade names (and
trademark applications (whether or not registered) together with all goodwill
associated therewith, and any renewals, extensions or modifications thereto in
the Territory), trade dress and packaging which (a) are owned by or Controlled
by either Party and (b) are applied to or used with Collaboration Products or
any Promotional Materials.
A.51 "PROGRAM PLAN" shall mean the comprehensive plan and overall
strategy, and any updates thereto, for the Development, manufacture and
Commercialization of Collaboration Products. The Program Plan shall be comprised
of the Development Plan, Process Development/Manufacturing Plan, Regulatory
Plan, Commercial Plan and other allowable activities (and Other Allowable
Expenditures) and an associated budget for the foregoing.
A.52 "PROMOTE" OR "PROMOTION" OR "PROMOTING" OR "PROMOTIONAL" shall
mean, with respect to a Collaboration Product, those activities and obligations
other than Detailing undertaken by a Party to encourage sales of such
Collaboration Product including, but not limited to, journal advertising, direct
mail programs, direct-to-consumer advertising, education, convention exhibits,
and other forms of advertising, promotion and any other communication specified
in any Commercial Plan.
A-7
A.53 "PROMOTIONAL MATERIALS" shall mean all sales representative
training materials and all written, printed, graphic, electronic, audio or video
matter including, but not limited to, journal advertisements, sales visual aids,
direct mail, direct-to-consumer advertising, Internet postings, broadcast
advertisements, and sales reminder aids (e.g., scratch pads, pens and other such
items) intended for use or used by a Party in connection with any Promotion (as
defined herein) or Detailing of a Collaboration Product, except Product
Labeling.
A.54 "RECALL" OR "RECALLING" shall mean an event, incident or
circumstance which may result in the need for a "recall" or "market withdrawal"
(as such terms are defined in U.S. regulations in 21 CFR 7.3 or other similar
national, state or local law or regulations) or field alert or field correction
of a Collaboration Product or any lots thereof.
A.55 "REGULATORY APPROVAL" shall mean any approvals (including
supplements, amendments, pre- and post-approvals and price approvals), licenses,
registrations or authorizations (including designations of a Collaboration
Product as an "Orphan Product" under the Orphan Drug Act), howsoever called, of
any Regulatory Authority, which are necessary for the distribution, importation,
exportation, manufacture, production, use, storage, transport or clinical
testing and/or sale of a Collaboration Product in a regulatory jurisdiction.
Regulatory Approval shall not include any site license for an Amgen
manufacturing facility.
A.56 "REGULATORY AUTHORITY" shall mean the FDA or any counterpart of the
FDA outside the United States, or other national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity with authority over the distribution, importation,
exportation, manufacture, production, use, storage, transport or clinical
testing and/or sale of a Collaboration Product.
A.57 "REGULATORY FILINGS" shall mean, collectively, INDs, BLAs,
establishment license applications (ELAs) and drug master files (DMFs),
applications for designation of a Collaboration Product as an "Orphan
Product(s)" under the Orphan Drug Act or any other similar filings (including
any foreign equivalents and further including any related correspondence and
discussions), and all data contained therein, as may be required by the FDA or
equivalent foreign Regulatory Authorities for the Development, manufacture or
Commercialization of a Collaboration Product.
A.58 "REGULATORY PLAN" shall mean the comprehensive plan or plans and
overall strategy, and any updates thereto, for preparing and filing any and all
Regulatory Filings regarding Collaboration Products (in accordance with
customary standards for a product of comparable market potential) and for
communications with Regulatory Authorities, including all interactions with
respect to such Regulatory Filings. The Regulatory Plan shall include, but not
be limited to, a reasonably detailed description of the schedule of the work
activities, responsibility for the work activities and an associated budget.
A.59 "TERRITORY" shall mean the world.
A-8
A.60 "THIRD PARTY" shall mean any individual, partnership, joint
venture, corporation, trust, estate, unincorporated organization, government or
any department or agency thereof, or any other entity other than Amgen or Hyseq
or an Affiliate of either of them.
A.61 "TRANSITION DATE" shall mean the date that the Steering Committee
shall have decided to [***].
A.62 Each of the following definitions are found in the body of this
Agreement as indicated below:
DEFINED TERM LOCATION
---------------------------------------------- --------------
"ACCME" Section 5.6
"ACQUIRED PARTY" Section 16.10
"AMA" Section 5.6
"AMGEN" Page 1
"AMGEN INDEMNITEES" Section 14.2
"CO-DETAILER" Section 5.1
"COLLABORATION EXPENDITURES" Schedule I
"COMMERCIAL LEAD" Section 5.1
"DEFAULTING PARTY" Section 16.6(a)
"DEVELOPMENT EXPENDITURES" Schedule I
"DEVELOPMENT LEAD" Section 3.2(a)
"EFFECTIVE DATE" Page 1
"FTE" Schedule I
"FTE COSTS" Schedule I
"GENERAL AND ADMINISTRATIVE EXPENDITURES" Schedule I
"HYSEQ" Page 1
"HYSEQ INDEMNITEES" Section 14.1
"INDEMNIFY" OR "INDEMNIFIED" Section 14.1
"INTERNAL FTE" Schedule I
"MANUFACTURING LEAD" Section 6.1
"NON-DEFAULTING PARTY" Section 16.6(a)
"NOTICE OF DEFAULT" Section 16.6(a)
"OTHER ALLOWABLE EXPENDITURES" Schedule I
"PARTY" OR "PARTIES" Page 1
"PERFORMANCE DEFAULT" Section 16.6(a)
"PHRMA" Section 5.6
"PROCESS DEVELOPMENT/MANUFACTURING EXPENDITURES" Schedule I
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
A-9
DEFINED TERM LOCATION
---------------------------------------------- --------------
"REGULATORY EXPENDITURES" Schedule I
"REGULATORY LEAD" Section 4.1
"REPRESENTATION DEFAULT" Section 16.6(a)
"RCT" Section 6.7
"SOPS" Section 4.9(a)
"STEERING COMMITTEE" Section 2.2
"TERM" Section 16.1
"WARRANT PURCHASE AGREEMENT" Section 7.1
"WIND DOWN COSTS" Schedule I
A-10
EXHIBIT B
PROTEIN SEQUENCE OF ALFIMEPRASE
RN 259074-76-5 ZREGISTRY
CN 3-203-Fibrolase [3-serine] (Agkistrodon contortrix contortrix recombinant)
(9CI) (CA INDEX NAME)
FS PROTEIN SEQUENCE
SQL 201
NTE
----------------------------------------------------------------------
type ------ location ------ description
----------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇-▇▇▇ - ▇▇▇-▇▇▇ disulfide bridge
bridge ▇▇▇-▇▇▇ - ▇▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇-▇▇▇ - ▇▇▇-▇▇▇ disulfide bridge
----------------------------------------------------------------------
SEQ 1 SFPQRYVQLV IVADHRMNTK YNGDSDKIRQ WVHQIVNTIN EIYRPLNIQF
▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
101 DFDGDTVGLA YVGGMCQLKH STGVIQDHSA INLLVALTMA HELGHNLGMN
151 HDGNQCHCGA NSCVMAAMLS DQPSKLFSDC SKKDYQTFLT VNNPQCILNK
201 P
SEQ3 1 Ser-Phe-Pro-Gln-Arg-Tyr-Val-Gln-Leu-Val-
11 ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
▇▇ ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
31 Trp-Val-His-Gln-Ile-Val-Asn-Thr-Ile-Asn-
41 Glu-Ile-Tyr-Arg-Pro-Leu-Asn-Ile-Gln-Phe-
51 Thr-Leu-Val-Gly-Leu-Glu-Ile-Trp-Ser-Asn-
61 Gln-Asp-Leu-Ile-Thr-Val-Thr-Ser-Val-Ser-
71 His-Asp-Thr-Leu-Ala-Ser-Phe-Gly-Asn-Trp-
81 ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
▇▇ ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
101 Asp-Phe-Asp-Gly-Asp-Thr-Val-Gly-Leu-Ala-
111 ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
▇▇▇ ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
131 Ile-Asn-Leu-Leu-Val-Ala-Leu-Thr-Met-Ala-
141 His-Glu-Leu-Gly-His-Asn-Leu-Gly-Met-Asn-
151 His-Asp-Gly-Asn-Gln-Cys-His-Cys-Gly-Ala-
161 Asn-Ser-Cys-Val-Met-Ala-Ala-Met-Leu-Ser-
171 Asp-Gln-Pro-Ser-Lys-Leu-Phe-Ser-Asp-Cys-
181 Ser-Lys-Lys-Asp-Tyr-Gln-Thr-Phe-Leu-Thr-
191 Val-Asn-Asn-Pro-Gln-Cys-Ile-Leu-Asn-Lys-
201 Pro
B-1
EXHIBIT C
AMGEN IND AS OF THE EFFECTIVE DATE
FDA FILE # [***]
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C-1
EXHIBIT D
AMGEN PATENT RIGHTS AS OF THE EFFECTIVE DATE
PATENT/PATENT APPLICATION COUNTRY OUR REF.:
-------------------------------------------------------------------------------------------------
Size Enhanced Fibrinolytic Enzymes: US - Granted 6,214,594 [***]
Limitations of Plasma Inactivation
CA - [***] [***] CA
Appln # not yet available.
EP - Appln #99922877.8 [***] (EP)
PCT - Appln #99/10108 [***] (PCT)
US - Provisional 60/084,833 [***]
-------------------------------------------------------------------------------------------------
Pharmaceutical Compositions of US - Appln #09/411,335 [***]
Fibrinolytic Agent
PCT - Appln #00/27022 [***] (PCT)
-------------------------------------------------------------------------------------------------
Fibrinolytically Active Polypeptide US - Granted 6,261,820 [***]
PCT - Appln #00/27029 [***] (PCT)
-------------------------------------------------------------------------------------------------
DNA Molecules Encoding US - Appln #09/846,729 [***]
Fibrinolytically Active Polypeptide
-------------------------------------------------------------------------------------------------
Method for Localized Administration of US - Appln #09/466,276 [***]
Fibrinolytic Metalloproteinases
PCT - Appln #00/34143 [***] (PCT)
-------------------------------------------------------------------------------------------------
D-1
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SCHEDULE I
ALLOWABLE COLLABORATION EXPENDITURES
TO THE OPERATING PROFIT AND LOSS ACCOUNT
The Parties have agreed to pursue a collaboration with respect to Collaboration
Products and jointly share certain costs and expenditures related to these
activities. This Schedule I outlines the understanding of the Parties as to
which activities and associated expenditures can be submitted for consideration
in a Program Plan and budget (See Collaboration Program Plan Budget, Schedule
II) for Development, manufacturing and Commercialization of Collaboration
Products; [***].
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I-1
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SCHEDULE II
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II-1
SCHEDULE III
WARRANT PURCHASE AGREEMENT
BY AND BETWEEN
AMGEN INC
AND
HYSEQ, INC (D.B.A. HYSEQ PHARMACEUTICALS)
III-1
SCHEDULE IV
LICENSE AGREEMENT
BY AND BETWEEN
AMGEN INC
AND
HYSEQ, INC (D.B.A. HYSEQ PHARMACEUTICALS)
IV-1
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LICENSE AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
HYSEQ, INC.
(D.B.A. HYSEQ PHARMACEUTICALS)
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "License Agreement") is made effective as of
_______________, ______ (the "Effective Date") by and between AMGEN INC., a
Delaware corporation having its principal place of business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("Amgen") and HYSEQ, INC., D.B.A.
HYSEQ PHARMACEUTICALS, INC., a Nevada corporation having its principal place of
business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("Hyseq").
Amgen and Hyseq are sometimes referred to herein individually as a "Party" and
collectively as the "Parties".
RECITALS
WHEREAS, Amgen and Hyseq have been collaborating in the joint development
and commercialization of a protein known as Alfimeprase (and other variants of
Alfimeprase) under the terms and conditions of that certain Collaboration
Agreement between the Parties, dated January 8, 2002 ("Collaboration
Agreement");
WHEREAS, pursuant to Article 15 of the Collaboration Agreement, Amgen has
elected to exercise its right to convert its right to jointly develop and
commercialize Alfimeprase (and other variants of Alfimeprase) into the grant to
Hyseq of an exclusive license under certain Amgen rights to Develop, manufacture
and Commercialize Alfimeprase (and other variants of Alfimeprase);
WHEREAS, Hyseq wishes to exclusively license such Amgen rights from Amgen
in connection with the Development, manufacture and Commercialization of the
Licensed Product(s) (as hereinafter defined), on the terms and conditions
herein;
NOW THEREFORE, based on the foregoing premises and the mutual covenants
and obligations set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used but not otherwise defined herein have the meanings
provided in EXHIBIT A hereto.
1
ARTICLE 2
GRANT OF LICENSES AND OTHER RIGHTS
2.1 PATENT LICENSES. Amgen hereby grants to Hyseq an exclusive license
(even as to Amgen) under Amgen Technology to make, have made, use, sell, lease,
offer to sell or lease, have sold, import, export or otherwise exploit, transfer
physical possession of and transfer title or interest in and to Licensed
Products in the Territory.
2.2 TRADEMARK; COPYRIGHT LICENSES.
(a) Amgen hereby grants to Hyseq an exclusive royalty-free license, with
the right to grant sublicenses (subject to Hyseq's compliance with Section 2.3),
under Amgen's entire right, title and interest in and to the Product Trademarks,
to use and display the Product Trademarks in connection with Licensed Products
in the Territory. For the avoidance of doubt, Hyseq shall have the right to
select for and use and display with Licensed Products such Trademarks as it
desires.
(b) Amgen hereby grants to Hyseq an exclusive royalty-free license under
Amgen's entire right, title and interest in any copyrights in and to Promotional
Materials, with the right to grant sublicenses subject to Hyseq's compliance
with Section 2.3 of this License Agreement), to reproduce, distribute copies of,
prepare derivative works of and publicly perform and display such Promotional
Materials in connection with Licensed Products in the Territory solely in
compliance with the terms and conditions of this License Agreement.
(c) Other than with respect to the rights and licenses granted to Joint
Know-How under this License Agreement, each Party shall have the unrestricted,
royalty-free, worldwide right to make, have made, use, sell, lease, offer to
sell or lease, have sold, import, export or otherwise exploit, or transfer
physical possession of or title in, Joint Know-How, without accounting.
2.3 SUBLICENSING.
(a) Hyseq will have the sole right to determine whether to sublicense
any of its rights under Section 2.1 or 2.2. Any such sublicense shall require
the Sublicensee to comply with the obligations of Hyseq as contained herein
(specifically including, without limitation, obligations under Section 6.6,
Article 7 and Section 14.15), and including an obligation of the Sublicensee to
account for and report its sales of Licensed Products on the same basis as if
such sales were Net Sales by Hyseq. Any such sublicense shall provide for the
termination of the sublicense, or the conversion to a license directly between
such Sublicensee and Amgen, at the option of Amgen, upon termination of this
License Agreement pursuant to Article 12. Hyseq shall forward to Amgen a copy of
each fully executed sublicense agreement within sixty (60) days of the execution
of such agreement.
(b) Notwithstanding the sublicensing of all or part of Hyseq's rights
and obligations hereunder, Hyseq shall remain responsible for the full and
complete performance of all of Hyseq's obligations and duties under this License
Agreement. For the avoidance of doubt, Hyseq shall forward to Amgen and
acknowledges that Amgen shall be entitled to receive
2
Royalties on Net Sales of Licensed Product(s) sold by Sublicensees hereunder and
that Hyseq shall be responsible to Amgen for paying Royalties due on Net Sales
of Product(s) sold by Sublicensees.
2.4 ASSIGNMENT TO HYSEQ. Pursuant to Section 16.9(c)(ii) of the
Collaboration Agreement, Amgen shall have transferred or is in the process of
transferring to Hyseq all right, title and interest in all Regulatory Filings
and Regulatory Approvals owned in each case by Amgen and shall have delivered or
is in the process of delivering to Hyseq all correspondence between Amgen and
Regulatory Authorities relating to all Regulatory Filings and Regulatory
Approvals. At Hyseq's request and expense, within [***] after such request Amgen
will provide Hyseq with access to any pre-clinical and clinical information
(reasonably necessary to the continued Development, manufacturing and
Commercialization of a Collaboration Product), and Amgen will assist Hyseq in
responding to any request or inquiry regarding such information by a Regulatory
Authority.
2.5 MANUFACTURING LICENSE TO HYSEQ. Pursuant to Section 4.1, Amgen shall
grant to Hyseq an exclusive license, with a limited right to sublicense (to
Third Party manufacturers pursuant to Section 4.2), to make, have made and use
Amgen Material and Manufacturing Information solely for the purposes set forth
in Section 3.1 below.
2.6 RETAINED RIGHTS. With respect to the licenses granted under this
Article 2, Amgen expressly reserves for itself and its Affiliates a
non-transferable, non-sublicensable right to make, have made and use (but not to
transfer, sell, have sold, offer to sell or lease, import, export or otherwise
exploit or transfer possession of, title to or interest in) Licensed Products
under Amgen Technology and Amgen Material and Manufacturing Information which
are solely for internal research purposes unrelated to Licensed Products. For
the avoidance of doubt, Amgen shall further retain all rights in Amgen
Technology and the Amgen Material and Manufacturing Information not expressly
licensed hereunder, including the right to make, have made, use, sell, lease,
offer to sell or lease, have sold, import, export or otherwise exploit, transfer
physical possession of and transfer title or interest in and to products, other
than Licensed Products, for any purpose in the Territory.
ARTICLE 3
DEVELOPMENT AND COMMERCIALIZATION
3.1 DEVELOPMENT AND COMMERCIALIZATION. At its discretion Hyseq shall
have sole and full control, authority and responsibility for conducting, funding
and pursuing all aspects of Development and Commercialization of each said
Licensed Product in the Territory.
3.2 REGULATORY FILINGS AND REGULATORY APPROVALS. With respect to each
Licensed Product, at its discretion Hyseq will prepare, file and own all right,
title and interest in Regulatory Filings and Regulatory Approvals relating to
each said Licensed Product in the Territory.
3.3 ANNUAL REPORTS. Hyseq will provide Amgen with detailed written
annual reports concerning their efforts regarding Development and
Commercialization (pursuant to Article 3)
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3
and regarding manufacturing (pursuant to Article 4) of the Licensed Products. At
Amgen's request, Hyseq shall promptly discuss such annual report and any
progress regarding Development, manufacturing and Commercialization with Amgen.
ARTICLE 4
MANUFACTURE AND SUPPLY
4.1 MANUFACTURING RIGHT. Hyseq shall be responsible for manufacturing
and supplying Licensed Products for Development and Commercialization in the
Territory and for making all decisions with respect thereto in its sole
discretion, including without limitation, decisions relating to process
development work to support quality assurance, improving manufacturing/cost
efficiency and commercial scale-up manufacturing. For the avoidance of doubt,
Hyseq shall have final decision making authority to fulfill its regulatory
responsibilities over all steps of the manufacturing process (including bulk,
finish and fill, labeling and packaging, lot release and management of
subcontractors).
4.2 TRANSFER OF MANUFACTURING RESPONSIBILITIES. Transfer of
manufacturing responsibilities from Amgen to Hyseq or to a Third Party
manufacturer approved by Amgen pursuant to Section 6.7 of the Collaboration
Agreement will take place according to Section 16.9(c) of the Collaboration
Agreement.
ARTICLE 5
CONSIDERATION
5.1 CLINICAL MILESTONES.
(a) Within [***] days following the first achievement or occurrence with
the first Licensed Product(s) of each of the following milestone events by
performance of Hyseq or an Affiliate or Sublicensee of Hyseq ("Milestone
Event(s)"), Hyseq shall pay to Amgen the corresponding one-time, non-creditable,
non-refundable milestone payments set forth herein ("Milestone Payment(s)"):
MILESTONE EVENT MILESTONE PAYMENT
--------------- -----------------
(i) [***] [***]
(ii) [***] [***]
(iii) [***] [***]
(iv) [***] [***]
(v) [***] [***]
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4
MILESTONE EVENT MILESTONE PAYMENT
--------------- -----------------
TOTAL $40,000,000.00
(b) For purposes of clarification, [***]. No Milestone Payment shall be
payable more than once, no matter how many times achieved by one or more
Licensed Product(s). Each such Milestone Payment shall be nonrefundable and
noncreditable against Royalties payable pursuant to Section 5.2 and any other
fees, other Milestone Payments or other payments due Amgen with respect to
Licensed Product(s) under this License Agreement.
(c) In the event [***] shall be the [***] by Hyseq, and the Milestone
Event(s) set forth in Sections 5.1(a)(i) or 5.1(a)(ii) is/are first achieved
with respect to the [***], Hyseq shall pay to Amgen [***] of the corresponding
Milestone Payment for any such achieved Milestone Event, with the balance of any
such corresponding Milestone Payment being due and payable upon the achievement
of such Milestone Event with respect to [***]. In the event that Hyseq shall not
have obtained Regulatory Approval for the [***] in the United States, [***]
gross sales in the United States for the [***] are or exceed [***], (based on
data provided by IMS International, or if such data shall not be available,
based on such other data mutually agreed to by Amgen and Hyseq), then Hyseq
shall immediately pay the balance of any partially paid Milestone Payment under
this Section 5.3(c).
(d) If the Effective Date of this License Agreement is after the date of
achievement of any Milestone Event(s) set forth in Sections 5.1(a)(i) and
5.1(a)(ii), then the corresponding Milestone Payment of such previously achieved
Milestone Event shall be deemed waived and not payable to Amgen.
(e) If the Effective Date of this License Agreement is after the date of
achievement of any Milestone Event(s) set forth in Sections 5.1(a)(iii), (iv) or
(v), the corresponding Milestone Payment shall be due within [***] after the
Effective Date of this License Agreement. Notwithstanding the above sentence,
the Ten Million Dollar ($10,000,000.00) Regulatory Approval Milestone incurred
by Hyseq under Section 7.2 of the Collaboration Agreement as a consequence of
the achievement of any such Milestone Event shall be creditable against any
Milestone Payments due for the achievement of any Milestone Event(s) set forth
in Sections 5.1(a)(iii), (iv) or (v) prior to or during the Term of this License
Agreement.
5.2 ROYALTIES. Subject to Sections 5.3 and 5.4, below, Hyseq shall pay
to Amgen a Royalty, based on the following Royalty rates, for annual Net Sales
of each Licensed Product (on a Licensed Product-by-Licensed Product basis) by
Hyseq, its Affiliates, or its Sublicensees in the Territory:
(a) a Royalty rate of [***] of that portion of annual Net Sales in the
Territory of each such Licensed Product that is less than or equal to [***];
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5
(b) a Royalty rate of [***] of that portion of annual Net Sales in the
Territory of each such Licensed Product that is greater than [***] and less than
or equal to [***]; and
(c) a Royalty rate of [***] of that portion of annual Net Sales in the
Territory of each such Licensed Product that is greater than [***].
5.3 [***] Hyseq acknowledges that Hyseq may be obligated to pay Third
Party Payments to [***] for licensing of [***] technology with respect to
Licensed Products, in addition to the Milestone Payments set forth in Section
5.1 and the Royalties set forth in Section 5.2 above. Such payments shall be
non-creditable against any payments due to Amgen under this License Agreement.
5.4 THIRD PARTY ROYALTY REDUCTION. Hyseq shall be responsible for
obtaining any licenses, and for making any Third Party Payments thereunder, or
making any then-due Third Party Payments to Amgen (for forwarding to the
licensing Third Party) under any sublicenses granted by Amgen hereunder, for
rights to any Third Party intellectual property required to make, have made,
use, sell, lease, offer to sell or lease, have sold, import, export or otherwise
exploit, or transfer physical possession of or title in, a Licensed Product in
one or more countries in the Territory. [***] if, and for so long as Hyseq is
required to pay such Third Party royalties for such license, [***] of the
royalties which are payable by Hyseq shall be creditable by Hyseq against any
Royalties due to Amgen under Section 5.2 above for the Net Sales of such
Licensed Product in such country, provided however, that, on a Licensed
Product-by-Licensed Product basis, Hyseq's Royalty rate set forth in Section 5.2
in any given year will not be reduced in excess of [***] as a consequence of any
royalties being creditable against the Royalties to be paid to Amgen by Hyseq.
Hyseq shall have sole discretion, authority and right with respect to
determining whether to enter into an agreement for a license or other rights and
to incur an obligation for any Third Party Payments.
5.5 COMPETITION REDUCTION. If, and for so long as one or more
Competitive Product(s) shall be commercially available in a country in the
Territory and shall have in the aggregate a share of more than [***] of the
total market of all Licensed Product(s) in that country as measured by sales
units (based on data provided by IMS International, or if such data shall not be
available, based on such other data mutually agreed to by Amgen and Hyseq),
Hyseq shall have the immediate right to reduce the Royalty rates on Net Sales of
each such Licensed Product(s) in such country by [***] of those set forth in
Section 5.2.
5.6 TERM OF ROYALTIES. Amgen's right to receive Royalties under Section
5.2 shall expire, on a Licensed Product-by-Licensed Product basis and
country-by-country basis, upon the later of: (a) [***] after the date of First
Commercial Sale of each such Licensed Product; or (b) the expiration of the
last-to-expire of the Amgen Patent Rights and (subject to the following
sentence) Joint Patent Rights containing an issued Valid Claim that, but for the
license granted by Amgen to Hyseq, would be infringed by the use or sale by
Hyseq, its Affiliates and Sublicensees of such Licensed Product in such country.
Where the Joint Patent Rights described in subparagraph (b) subsist after expiry
of the Amgen Patent Rights, then upon such expiry the Royalties payable pursuant
to Section 5.2 (as reduced by Sections 5.4 and 5.5, as applicable) [***], and
shall continue to be payable by Hyseq if:
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6
(i) a mutually acceptable [***] has provided a [***] to both Parties to
the effect that but for a license under such subsisting Joint Patent Rights, the
actual or theoretical using (in accordance with a [***] of, or with published,
[***] clinical human trial results regarding, a Licensed Product) or selling by
a Third Party of a competing pharmaceutical product within the meaning of
Competitive Product would infringe an issued Valid Claim under the Joint Patent
Rights, or
(ii) Hyseq has elected to continue to retain its exclusive rights to such
subsisting Joint Patent Rights,
but failing which Hyseq's obligation to pay all Royalties shall expire and each
Party shall thereafter be free to use and exploit their respective interest in
the Joint Patent Rights without the obligation to obtain the consent of, or to
account to, the other Party. Notwithstanding any of the foregoing, after
expiration of Amgen's right to receive Royalties for at least one Licensed
Product (i.e. the first Licensed Product), Amgen's right to receive Royalties
for any subsequent Licensed Product shall be determined solely by subparagraph
(b) above and not by subparagraph (a).
5.7 SUBLICENSING IN ASIAN COUNTRIES. In the event of a sublicensing by
Hyseq to a Third Party of the right to Develop and/or Commercialize Licensed
Products in Asian Countries, Amgen will waive all of Hyseq's Milestone Payments
described in Section 5.1(a)(v) above (and the Milestone Payments due under
Section 5.1(a)(i) or Section 5.1(a)(ii) shall only apply upon achievement of the
corresponding Milestone Event in a country other than a country within the Asian
Countries), and the Royalty payment described in Section 5.2 above with respect
to Net Sales of Licensed Products in such Asian Countries, and will instead
receive [***] of all consideration received by Hyseq from such Sublicensee. In
all other regions, Hyseq shall remain responsible for all other rights and
obligations under this License Agreement, including making all payments to Amgen
in accordance with Sections 5.1 and 5.2 and in guaranteeing the performance of
such Sublicensee for all other obligations to Amgen.
ARTICLE 6
INTELLECTUAL PROPERTY
6.1 TECHNOLOGY OWNERSHIP. Ownership of inventions shall be determined in
accordance with the rules of inventorship under United States patent laws.
Subject to the licenses granted in Section 2.1, as between the Parties, Amgen
shall own all right, title and interest in and to Amgen Technology, and any
Confidential Information contained therein shall be considered the Confidential
Information of Amgen. As between the Parties, all right and interest in and to
Joint Know-How (which shall be considered the joint Confidential Information of
the Parties) and Joint Patent Rights shall be owned jointly by Hyseq and Amgen,
and shall be subject to the license granted to Hyseq in Section 2.1.
6.2 PROSECUTION.
(a) At its own cost and expense, Amgen will be responsible (using
mutually acceptable outside counsel) for the filing, prosecution, defense and
maintenance of Amgen
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7
Patent Rights before all patent authorities in the Territory. [***] such filing,
prosecution and defense of the Amgen Patent Rights by Amgen and [***] Amgen
[***]. To that end, Amgen shall instruct such outside counsel to furnish Hyseq
with a reasonably complete draft of each potential submission to a patent
authority regarding Amgen Patent Rights no later than [***] (or if given less
than [***] to respond as soon as practicable) prior to the date such submission
is proposed to be made, and shall [***] thereon. Additionally, Amgen shall
instruct such outside counsel to provide Hyseq with a copy of each submission
made to and document received from a patent authority regarding any Amgen Patent
Rights reasonably promptly after making such filing or receiving such document.
If Amgen determines in its sole discretion to not file, prosecute, defend or
maintain any claim or patent application or patent within Amgen Patent Rights in
any country, then Amgen shall provide Hyseq with [***] prior written notice of
such determination to provide Hyseq with the right and opportunity to file,
prosecute and maintain such claim or patent application or patent on behalf of
Amgen (at Hyseq's sole cost and expense).
(b) At its own cost and expense, Hyseq will be responsible (using
mutually acceptable outside counsel) for the filing, prosecution, defense and
maintenance of Joint Patent Rights before all patent authorities in the
Territory. [***] such filing, prosecution and defense of the Joint Patent Rights
by Hyseq and [***], Hyseq shall [***]. To that end, Hyseq shall instruct such
outside counsel to furnish Amgen with a reasonably complete draft of each
potential submission to a patent authority regarding Joint Patent Rights no
later than [***] (or if given less than [***] to respond as soon as practicable)
prior to the date such submission is proposed to be made, and shall [***]
thereon. Additionally, Hyseq shall instruct such outside counsel to provide
Amgen with a copy of each submission made to and document received from a patent
authority regarding any Joint Patent Rights reasonably promptly after making
such filing or receiving such document. If Hyseq determines in its sole
discretion to not file, prosecute, defend or maintain or any claim or patent
application or patent within Joint Patent Rights in any country, then Hyseq
shall provide Amgen with [***] prior written notice of such determination to
provide Amgen with the right and opportunity to file, prosecute, defend and
maintain such claim or patent application or patent on behalf of both Parties
(at Amgen's sole cost and expense).
(c) Amgen and Hyseq shall each provide to the other any invention
disclosures submitted to its respective outside or in-house patent counsel in
the normal course of its business which disclose an invention within Amgen
Know-How and Joint Know-How, respectively. Amgen and Hyseq shall cooperate with
each other and render all reasonable assistance in prosecuting and maintaining
all intellectual property licensed under this License Agreement. Both Parties
shall meet regularly, but not less than on a quarterly basis, to discuss the
prosecution (and other related proceedings, such as interferences and
oppositions) of all intellectual property licensed under this License Agreement.
Amgen and Hyseq shall cooperate with each other in any such matters, and shall
sign any necessary legal papers and provide the Party responsible for such
prosecution with data or other information in support thereof (and use their
best efforts to ensure the cooperation of any of their respective personnel and,
in the case of Hyseq, it's Affiliates and licensee(s) as might reasonably be
requested).
(d) Hyseq shall be responsible (using mutually acceptable outside
counsel) for the filing, prosecution, defense and maintenance of the Product
Trademarks before all trademark authorities in the Territory. For the Product
Trademarks solely or jointly owned by Amgen,
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Amgen shall have the [***] on such filing, prosecution and defense of the
Product Trademarks by Hyseq and [***] and Hyseq shall [***]. To that end, Hyseq
shall instruct such outside counsel to furnish Amgen with a reasonably complete
draft of each submission to a trademark authority regarding the Product
Trademarks no later than [***] prior to the date such submission is proposed to
be made, or if given less than [***] to respond as soon as practicable, and
Hyseq will [***] thereon. Additionally, Hyseq shall instruct such outside
counsel to provide Amgen with a copy of each submission made to or document
received from a trademark authority regarding any Product Trademarks reasonably
promptly after making such filing or receiving of such document. If Hyseq
determines in its sole discretion to not file, prosecute, defend or maintain a
Product Trademark in any country, then Hyseq shall provide Amgen with [***]
prior written notice of such determination and shall provide Amgen with the
right and opportunity to file, prosecute, defend and maintain such Product
Trademark on behalf of Hyseq.
6.3 INFRINGEMENT OF PATENTS AND TRADEMARKS BY THIRD PARTIES.
(a) At its own cost and expense, Amgen may, but shall not be obligated
to, elect to enforce Amgen Patent Rights against any actual, alleged or
threatened infringement by Third Parties and to defend the Amgen Patent Rights
against any challenges in the Territory. In the event Amgen shall so elect to
enforce Amgen Patent Rights against a Third Party infringement which may in any
way affect the rights conferred to Hyseq pursuant to this License Agreement to
Develop, manufacture and Commercialize Licensed Products, Amgen shall [***] and
Hyseq, at Amgen's request [***]. If Amgen finds it necessary or desirable to
[***], at the expense of Amgen. In the event Amgen does not commence an
enforcement and/or defense action pursuant to this Section 6.3(a) within [***]
after Hyseq notifies Amgen or is notified by Amgen in writing of an actual,
alleged or threatened infringement by a Third Party of the Amgen Patent Rights
in the Territory (or of the filing of a declaratory judgment action) which may
in any way affect the rights conferred to Hyseq pursuant to this License
Agreement to Develop, manufacture and Commercialize Licensed Products, Hyseq
shall be entitled to bring and prosecute such an action at its own cost and
expense. If Hyseq elects to bring and prosecute such an action, then Hyseq shall
[***], and Amgen (at Hyseq's request [***]). If Hyseq finds it necessary or
desirable to [***] at Hyseq's expense. Amgen shall, at its own expense, be
entitled to participate in and to have counsel selected by it participate in any
action in which Amgen is a named party.
(b) At its own cost and expense, Hyseq may, but shall not be obligated
to, elect to enforce Joint Patent Rights against any actual, alleged or
threatened infringement by Third Parties and to defend the Joint Patent Rights
against any challenges in the Territory. In the event Hyseq shall so elect,
Hyseq shall [***], and Amgen (at Hyseq's request [***]). If Hyseq finds it
necessary or desirable to [***], at the expense of Hyseq. In the event Hyseq
does not commence an enforcement and/or defense action pursuant to this Section
6.3(b) within [***] after Amgen notifies Hyseq or is notified by Hyseq in
writing of an actual, alleged or threatened infringement by a Third Party of the
Joint Patent Rights in the Territory (or of the filing of a declaratory judgment
action), Amgen shall be entitled to bring and prosecute such an action at its
own cost and expense. If Amgen elects to bring and prosecute such an action,
then Amen shall [***], and Hyseq (at Amgen's request [***]). If Amgen finds it
necessary or desirable to [***], at Amgen's expense. Hyseq shall, at its own
expense, be entitled to participate in and to have counsel selected by it
participate in any action in which Hyseq is a named party.
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(c) At its own cost and expense, Hyseq may, but shall not be obligated
to, elect to enforce the Product Trademarks against Third Parties and to defend
the Product Trademarks against any challenges in the Territory. Hyseq shall
[***] determining the strategy and Amgen, at Hyseq's request [***] in any such
enforcement or defense. If Hyseq finds it necessary or desirable to [***], at
the expense of Hyseq. In the event Hyseq does not commence an enforcement and/or
defense action pursuant to this Section 6.3(c) within [***] after Amgen notifies
or is notified by Hyseq in writing of an infringement of the Product Trademarks
in the Territory (or of the filing of a declaratory judgment action, in the case
of defense actions), Amgen shall be entitled to bring and prosecute such an
action at its own cost and expense. If Amgen elects to bring and prosecute such
an action, then Amen shall [***] and Hyseq, at Amgen's request [***] in any such
enforcement or defense. If Amgen finds it necessary or desirable to [***] at
Amgen's expense. Hyseq shall, at its own expense, be entitled to participate in
and to have counsel selected by it participate in any action in which Hyseq is a
named party.
(d) Any recovery realized as a result of any such litigation described
in this Section 6.3 (after reimbursement of the Parties' reasonable attorneys'
fees for outside counsel and litigation expenses) shall be allocated [***].
(e) Neither Party shall enter into any settlement of any suit brought
under this Section 6.3 that affects the other Party's rights or interests
without the other Party's written consent, which consent shall not be
unreasonably withheld or delayed.
(f) A Party bringing suit under this Section 6.3 shall notify the other
Party of all substantive developments with respect to such enforcement or
defensive actions including, but not limited to, all material filings, court
papers and other related documents, substantive settlement negotiations and
offers of settlement.
(g) Each Party shall promptly notify the other upon becoming aware of
any Third Party infringement of the Amgen Patent Rights, Joint Patent Rights,
Product Trademarks, Amgen Know-How or Joint Know-How.
6.4 INFRINGEMENT OF THIRD PARTY RIGHTS.
(a) At its own cost and expense, Hyseq shall have the first right to
defend any action naming Hyseq, or both Parties, and claiming the infringement
of (i) any Third Party Patent Rights or other intellectual property rights
through the making, having made, using, selling, offering to sell or having
sold, importing, exporting or otherwise exploiting, transferring possession of
title or interest in, Licensed Product, or (ii) any Third Party Trademark
through the Development, manufacturing or Commercialization of a Licensed
Product. The Parties shall [***] during the defense of any such action. At
Hyseq's cost and expense, Amgen shall [***]. If Hyseq finds it necessary or
desirable to [***], at Hyseq's expense. Subject to the foregoing, Amgen shall,
at its own expense, be entitled to participate in and to have counsel selected
by it participate in any action in which Amgen is a named party.
(b) Each Party shall promptly notify the other upon becoming aware of
any actual, alleged or threatened Third Party claim or action against Hyseq
and/or Amgen for infringement of any Third Party Trademark through the
Development, manufacturing or Commercialization of
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a Licensed Product; or any Third Party Patent Rights through the making, having
made, using, selling, offering to sell, and importing, exporting or otherwise
transferring physical possession of or otherwise transferring title in and to
Licensed Products in the Territory.
(c) Neither Party shall enter into any settlement of any suit referenced
under this Section 6.4 that [***].
(d) A Party defending suit under this Section 6.4 shall notify the other
Party of all substantive developments with respect to such enforcement or
defensive actions including, but not limited to, all material filings, court
papers and other related documents, substantive settlement negotiations and
offers of settlement.
6.5 EMPLOYEE OBLIGATIONS. Prior to beginning work relating to any aspect
of the subject matter of this License Agreement and/or being given access to
Amgen Know-How or Joint Know-How or the Confidential Information of the other
Party, each employee, consultant or agent of Hyseq and Amgen shall have signed
or shall be required to sign a non-disclosure and invention assignment agreement
pursuant to which each such person shall agree to comply with all of the
obligations of Hyseq or Amgen, as appropriate, substantially including: (a)
promptly reporting any invention, discovery, process, software program or other
intellectual property right, as appropriate within Amgen Know-How or Joint
Know-How; (b) assigning to Hyseq or Amgen, as appropriate, all of his or her
right, title and interest in and to any such invention, discovery, process,
software program or other intellectual property right; (c) cooperating in the
preparation, filing, prosecution, maintenance and enforcement of any Patent
Rights; (d) performing all acts and signing, executing, acknowledging and
delivering any and all papers, documents and instruments required for effecting
the obligations and purposes of this License Agreement; and (e) abiding by the
obligations of confidentiality and non-use set forth in this License Agreement.
It is understood and agreed that any such non-disclosure and invention
assignment agreement need not be specific to this License Agreement.
6.6 PATENT MARKING. Licensed Products marketed and sold by Hyseq
hereunder shall be marked with appropriate patent numbers or indicia of Amgen
Patent Rights and/or Joint Patent Rights to the extent permitted by law in those
countries of the Territory in which such markings have notice value as against
infringers of patents.
6.7 WAIVER.
(a) Hyseq, on behalf of itself and its directors, employees, officers,
shareholders, agents, successors and assigns hereby waives any and all actions
and causes of action, claims and demands whatsoever, in law or equity, of any
kind it or they may have against Amgen, its directors, employees, officers,
shareholders, agents, successors and assigns, which may arise in any way, except
as a result of Amgen's gross negligence, recklessness or willful misconduct in
the performance of its rights or obligations under Sections 6.2, 6.3, 6.4 and
6.5.
(b) Amgen, on behalf of itself and its directors, employees, officers,
shareholders, agents, successors and assigns hereby waives any and all actions
and causes of action, claims and demands whatsoever, in law or equity, of any
kind it or they may have against Hyseq, its directors, employees, officers,
shareholders, agents, successors and assigns, which may arise in
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any way, except as a result of Hyseq's gross negligence, recklessness or willful
misconduct in the performance of its rights or obligations under Sections 6.2,
6.3, 6.4 and 6.5.
ARTICLE 7
PAYMENTS; RECORDS; AUDIT
7.1 PAYMENTS.
(a) U.S. Dollars. All payments to be made under this License Agreement
shall be made in United States Dollars by bank wire transfer in immediately
available funds to a bank account designated from time-to-time by Amgen.
(b) Royalty Payments. All Royalties payable to Amgen under this License
Agreement shall be paid within [***] of the end of each Calendar Quarter except
as otherwise specifically provided herein. Each payment of Royalties owing to
Amgen shall be accompanied by a statement certified by an executive officer of
Hyseq as accurate to the best of its ability consistent with Hyseq's standard
practices in performing such computations and in accordance with GAAP, (i) on a
country-by-country basis, of the amount of gross sales of Licensed Products, an
itemized calculation of Net Sales of each Licensed Product during such Calendar
Quarter, (ii) the amount of aggregate worldwide gross sales of Licensed Product
and Net Sales during such Calendar Quarter and (iii) on a cumulative basis for
the current year and the amount of Royalty due on Net Sales during such Calendar
Quarter.
(c) Foreign Exchange. Net Sales received in currencies other than United
States Dollars shall be converted into the United States Dollar equivalent, at
the average rate of exchange for the Calendar Quarter to which such payments
relate, as reported in Bloomberg Professional, a service of Bloomberg L.P.,
during the Royalty period of such Net Sales, or in the event Bloomberg
Professional is not available then The Wall Street Journal.
(d) Late Payments. Any amounts not paid by Hyseq when due under this
License Agreement shall be subject to interest from and including the date
payment is due through and including the date upon which Hyseq has made a wire
transfer of immediately available funds into an account designated by Amgen of
such payment at a rate equal to the lesser of (i) the sum of [***] plus the
annual prime rate or successive annual prime rates of interest quoted in the
Money Rates section of the on-line edition of the Wall Street Journal (at
▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇▇) calculated daily on the basis of a 365-day year
or (ii) the highest rate permitted by applicable law.
(e) Blocked Currency. If Hyseq, its Affiliates and/or Sublicensees are
unable to convert a foreign currency into United States Dollars for reasons
beyond their respective control, or are restricted by law or regulation from
remitting Royalties from any country of sale, Hyseq shall cause such payment to
be made by deposit to the credit and account of Amgen or its designated nominee
in any commercial bank designated by Amgen in the applicable country. Hyseq
shall deliver to Amgen proper evidence of such deposit.
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(f) Withholding Taxes. Any taxes, assessments and fees to be withheld by
Hyseq under the laws, rules or regulations of any foreign country for the
account of Amgen shall be promptly paid by Hyseq for and on behalf of Amgen to
the appropriate governmental authority, and Hyseq shall furnish Amgen with a
copy of the original official receipt for the payment of such tax within [***]
of payment. Any such tax, assessment and fee actually paid on Amgen's behalf
shall be deducted from any Royalty payments due to Amgen. Hyseq agrees to make
all lawful and reasonable efforts to minimize such taxes, assessments and fees
to Amgen.
7.2 RECORDS; AUDIT. Hyseq shall keep or cause to be kept such records as
are required in sufficient detail to track and determine (in a manner consistent
with GAAP) the accuracy of calculations of all sums or credits due under this
License Agreement and to accurately account for the calculations of all
Royalties due for Licensed Products under this License Agreement. Such records
shall be retained for a period of the later of (i) a [***] period following the
year in which any payments were made hereunder and/or (ii) the expiration of the
applicable tax statute of limitations (or any extensions thereof), or such
longer period as may be required by law. [***] per Calendar Year, Amgen shall
have the option to engage (at its own expense) an independent certified public
accountant, appointed by Amgen and reasonably acceptable to Hyseq, to examine in
confidence the books and records of Hyseq as may be necessary to determine, with
respect to any Calendar Year, the correctness or completeness of any report or
payment required to be made under this License Agreement; provided however, that
the books and records for any particular Calendar Year shall only be subject to
one audit. The report of such accountant shall be limited to a certificate
verifying any report made or payment submitted by Hyseq during such period but
may include, in the event the accountant shall be unable to verify the
correctness of any such payment, information relating to why such payment is
unverifiable. All information contained in any such certificate shall be deemed
the Confidential Information of Hyseq hereunder. If any audit performed under
this Section 7.2 discloses a variance of more than [***] from the amount of the
original report, showing the calculation of a Royalty under section 5.2 of this
License Agreement or calculation of consideration due to Amgen under section 5.7
of this License Agreement, Hyseq shall bear the full cost of the performance of
such audit. Upon the expiration of [***] following the end of any Calendar Year,
the calculation of any such amounts payable with respect to such Calendar Year
shall be binding and conclusive upon Amgen, and Hyseq shall be released from any
liability or accountability with respect to such amounts for such Calendar Year.
ARTICLE 8
PUBLICATIONS
8.1 PROCEDURE. Hyseq shall determine the overall strategy for and have
the right of publishing and presenting results of pre-clinical and clinical
studies of Licensed Products. However, each Party to this License Agreement
recognizes that the publication of papers regarding results of and other
information involving the activities under this License Agreement (including
oral presentations and abstracts) may be beneficial to both Parties, provided
such publications are subject to reasonable controls to protect Confidential
Information. In particular, it is the intent of the Parties to maintain the
confidentiality of any Confidential Information included in any patent
application until such patent application has been published. Accordingly, Amgen
will have the right to review and approve any paper proposed for publication by
Hyseq
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(including oral presentations and abstracts) which utilizes Confidential
Information of Amgen. Before any such paper is submitted for publication or an
oral presentation made, Hyseq will deliver a complete copy of the paper or
materials and abstracts for oral presentation to Amgen at least [***] prior to
submitting the paper to a publisher or making the presentation. Amgen will
review any such paper and give its comments to Hyseq within [***] after the
delivery of such paper to Amgen. With respect to oral presentation materials and
abstracts, Amgen will make reasonable efforts to expedite review of such
materials and abstracts and will return such items as soon as practicable to
Hyseq with appropriate comments, if any, but in no event later than [***] from
the date of delivery to Amgen. Hyseq will comply with Amgen's request to delete
references to Amgen's Confidential Information in any such paper and agrees to
withhold publication of same for an additional [***] in order to permit the
Parties to obtain patent protection, if either of the Parties deems it
necessary, in accordance with the terms of this License Agreement. Hyseq will
have the right to review and approve any paper proposed for publication by Amgen
(including oral presentations and abstracts) which describes Licensed Products
or which includes Confidential Information of Hyseq. Before any such paper is
submitted for publication or an oral presentation made, Amgen will deliver a
complete copy of the paper or materials and abstracts for oral presentation to
Hyseq at least [***] prior to submitting the paper to a publisher or making the
presentation. Hyseq will review any such paper, materials and abstracts and give
its comments to Amgen within [***] after the delivery of such paper to Hyseq.
With respect to oral presentation materials and abstracts, Hyseq will make
reasonable efforts to expedite review of such materials and abstracts and will
return such items as soon as practicable to Amgen with appropriate comments, if
any, but in no event later than [***] from the date of delivery to Hyseq. Amgen
will comply with Hyseq's request to delete references to Hyseq's Confidential
Information in any such paper and agrees to withhold publication of same for an
additional [***] in order to permit the Parties to obtain patent protection, if
either of the Parties deems it necessary, in accordance with the terms of this
License Agreement.
8.2 CREDIT. Any such publication or presentation will include
recognition of the contributions of the other Party according to standard
practice for assigning scientific credit, either through authorship or
acknowledgment as may be appropriate.
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ARTICLE 9
CONFIDENTIALITY
9.1 TREATMENT OF CONFIDENTIAL INFORMATION. The Parties agree that during
the Term, and for a period of [***] after this License Agreement expires or
terminates, a Party receiving Confidential Information of the other Party shall
(a) maintain such Confidential Information in confidence to the same extent such
Party maintains its own confidential or proprietary information or trade secrets
of similar kind and value (but at a minimum each Party shall use to maintain
such Confidential Information in confidence); (b) not disclose such Confidential
Information to any Third Party without the prior written consent of the
disclosing Party, except for disclosures to its Affiliates and Sublicensees who
agree to be bound by obligations of non-disclosure and non-use at least as
stringent as those contained in this Article 9; and (c) not use such
Confidential Information for any purpose except those purposes permitted by this
License Agreement. Neither Party shall knowingly disclose to the other Party any
Third Party information or know-how that such Party does not have the legal
right to disclose to the other Party and/or which it has a contractual
obligation not to disclose to the other Party.
9.2 AUTHORIZED DISCLOSURE. Notwithstanding any other provision of this
License Agreement, each Party may disclose Confidential Information of the other
Party:
(a) to the extent and to the persons and entities as required by an
applicable law, rule, regulation, legal process, court order or the rules of the
National Association of Securities Dealers or of a Regulatory Authority; or
(b) as necessary to file, prosecute or defend those patent applications
or patents for which either Party has the right to assume filing, prosecution,
defense or maintenance, pursuant to Section 6.2 of this License Agreement; or
(c) to prosecute or defend litigation or otherwise establish rights or
enforce obligations under this License Agreement, but only to the extent that
any such disclosure is necessary.
The Party required or intending to disclose the other Party's Confidential
Information under Sections 9.2(a) or (c) shall first have given prompt notice to
the other Party to enable it to seek any available exemptions from or
limitations on such disclosure requirement and shall reasonably cooperate in
such efforts by the other Party.
9.3 MATERIALS. Pursuant to Section 16.9(c) of the Collaboration
Agreement, the Parties anticipate that Amgen may transfer certain of its Amgen
Know-How and Amgen Material and Manufacturing Information to Hyseq; provided
however, that Hyseq agrees and acknowledges that Amgen may, but shall be under
no obligation, to transfer any Amgen Know-How and Amgen Material and
Manufacturing Information characterized, conceived, developed, derived,
generated or identified by Amgen after the Effective Date. Hyseq agrees that it
shall use such Amgen Know-How and Amgen Material and Manufacturing Information
only in accordance with the terms and conditions of this License Agreement and
will transfer such Amgen Know-How and Amgen Material and Manufacturing
Information only to a Third Party
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15
which has agreed in writing to be bound by obligations of confidentiality and
non-use at least as restrictive as set forth herein and only to use in
accordance with the terms of this License Agreement. Hyseq will promptly
thereafter provide notice of such transfer to Amgen.
9.4 PUBLICITY; TERMS OF AGREEMENT. The Parties agree that the existence
of and the material terms of this License Agreement shall be considered
Confidential Information of both Parties, subject to the special authorized
disclosure provisions set forth below in this Section 9.4 (in lieu of the
authorized disclosure provisions set forth in Section 9.2, to the extent of any
conflict) and without limiting the generality of the definition of Confidential
Information. The Parties will mutually agree upon the text of a press release
announcing the execution of this License Agreement. Thereafter, if either Party
desires to make a public announcement concerning this License Agreement or the
terms hereof that differs from this mutually agreed upon text, such Party shall
give reasonable prior advance notice of the proposed text of such announcement
to the other Party for its prior review and approval, such approval not to be
unreasonably withheld or delayed. A Party shall not be required to seek
permission from the other Party to repeat any information as to the terms of
this License Agreement that have already been publicly disclosed by such Party,
in accordance with the foregoing, or by the other Party. Either Party may
disclose the terms of this License Agreement to potential investors who agree to
be bound by obligations of non-disclosure and non-use at least as stringent as
those contained in this Article 9. The Parties acknowledge that Amgen and/or
Hyseq may be obligated to file a copy of this License Agreement with the U.S.
Securities and Exchange Commission (the "SEC") with its next quarterly report on
Form 10-Q, annual report on Form 10-K or current report on Form 8-K or with any
registration statement filed with the U.S. Securities and Exchange Commission
pursuant to the Securities Act of 1933, as amended, and each such Party shall be
entitled to make such filing; provided however, that it requests confidential
treatment of the more sensitive terms hereof to the extent such confidential
treatment is reasonably available to the filing Party under the circumstances
then prevailing. In the event of any such filing, the filing Party will provide
the non-filing Party with an advance copy of the License Agreement marked to
show provisions for which the filing Party intends to seek confidential
treatment and shall reasonably consider the non-filing Party's timely comments
thereon.
9.5 USE OF NAMES, LOGOS OR SYMBOLS. Subject to the licenses granted
under Section 2.2, and further subject to the authorized disclosure provisions
under Sections 9.2(a) and 9.4, no Party hereto shall use the name, Trademarks,
physical likeness, employee names or owner symbol of any other party for any
purpose (including, without limitation, private or public securities placements)
without the prior written consent of the affected Party, such consent not to be
unreasonably withheld or delayed so long as such use of name is limited to
objective statement of fact rather than for endorsement purposes. Hyseq shall
not use any Trademark either substantially resembling or which is confusingly
similar to any of Amgen's Trademarks in connection with the subject matter of
this License Agreement.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1 REPRESENTATIONS AND WARRANTIES OF HYSEQ. Hyseq hereby represents and
warrants to Amgen that as of the Effective Date of the Collaboration Agreement:
16
(a) Corporate Existence, Power and Authority. It is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Nevada and has full corporate power and authority and the legal right to own and
operate its property and assets and to carry on its business as it is now being
conducted and as contemplated in this License Agreement and to perform its
obligations hereunder including, without limitation the right to grant the
licenses granted hereunder. It has taken all necessary corporate action on its
part required to authorize the execution and delivery of this License Agreement
and the performance of its obligations hereunder.
(b) Binding Agreement. This License Agreement has been duly executed and
delivered on behalf of Hyseq and constitutes a legal, valid and binding
obligation of Hyseq that is enforceable against it in accordance with its terms.
(c) No Conflict. The execution, delivery and performance of this License
Agreement by Hyseq does not conflict with and would not result in a breach of
any agreement, instrument or understanding, oral or written, to which it is a
party or by which it may be bound, nor does it violate any material law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
(d) Validity. It is aware of no action, suit, inquiry or investigation
instituted by any Third Party which questions or threatens the validity of this
License Agreement.
(e) Expertise. In entering into this License Agreement, Hyseq has relied
solely on its own scientific and commercial experience and its own analysis and
evaluation of both the scientific and commercial value of the Licensed Products.
(f) Business Condition. It is not in violation of its charter, bylaws,
or any other organizational document, or in violation of any law, administrative
regulation, ordinance or order of any court or governmental agency, arbitration
panel or authority applicable to it, which violation, individually or in the
aggregate, would reasonably likely have a materially adverse effect on its
business or financial condition. Except as may be set forth in any documents
required to be filed by it under the Securities Act or Exchange Act, as the case
may be, it is not aware of any facts or circumstances, individually or in the
aggregate, which would reasonably likely have a materially adverse effect on its
business or financial condition.
10.2 REPRESENTATIONS AND WARRANTIES OF AMGEN. Amgen hereby represents and
warrants to Hyseq that as of the Effective Date of the Collaboration Agreement:
(a) Corporate Existence, Power and Authority. It is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Delaware and has full corporate power and authority and the legal right to own
and operate its property and assets and to carry on its business as it is now
being conducted and as contemplated in this License Agreement and to perform its
obligations hereunder including, without limitation, the right to grant the
licenses granted hereunder. It has taken all necessary corporate action on its
part required to authorize the execution and delivery of this License Agreement
and the performance of its obligations hereunder.
17
(b) Binding Agreement. This License Agreement has been duly executed and
delivered on behalf of Amgen and constitutes a legal, valid and binding
obligation of Amgen that is enforceable against it in accordance with its terms.
(c) No Conflict. The execution, delivery and performance of this License
Agreement by Amgen does not conflict with and would not result in a breach of
any agreement, instrument or understanding, oral or written, to which it is a
party or by which it may be bound, nor does it violate any material law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
(d) Validity. It is aware of no action, suit, inquiry or investigation
instituted by any Third Party which questions or threatens the validity of this
License Agreement.
(e) Business Condition. It is not in violation of its charter, bylaws,
or any other organizational document, or in violation of any law, administrative
regulation, ordinance or order of any court or governmental agency, arbitration
panel or authority applicable to it, which violation, individually or in the
aggregate, would reasonably likely have a materially adverse effect on its
business or financial condition. Except as may be set forth in any documents
filed with the Securities and Exchange Commission, as required to be filed by it
under the Securities Act or Exchange Act, as the case may be, it is not aware of
any facts or circumstances, individually or in the aggregate, which would
reasonably likely have a materially adverse effect on its business or financial
condition.
10.3 MUTUAL COVENANTS. Each Party hereby covenants to the other Party as
follows:
(a) No Conflict. It shall not during the term of this License Agreement
grant any right, license, consent or privilege to any Third Party(ies) in the
Territory which would conflict with the rights granted to the other Party under
this License Agreement, and shall not take any action that would in any way
prevent it from assuming its obligations or granting the rights granted to the
other Party under this License Agreement or that would otherwise materially
conflict with or adversely affect its obligations or its assumption of the
rights granted to the other Party under this License Agreement.
(b) Exclusivity. It shall work [***] with the other Party with respect
to Licensed Products (subject to Hyseq's rights under Sections 2.3 and 4.1 of
this License Agreement to grant sublicenses to Third Parties). It shall not,
directly or indirectly, make, have made, use, sell, offer to sell, import,
export or otherwise transfer physical possession of or otherwise transfer title
in (for purposes of Developing, manufacturing or Commercializing) a [***]
Product in the Territory, nor license or otherwise enable a Third Party to take
such actions during the Term. [***].
(c) Regulatory Data. It shall store and provide the other Party access
to source data supporting all Regulatory Filings and Regulatory Approvals for
the longer of (i) [***] or (ii) the time period required by any applicable
Regulatory Authority in the Territory. [***] of the first Licensed
Product, it shall also make its employees, consultants and agents reasonably
available upon reasonable notice from the other Party to consult with the other
Party on issues relating to
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Licensed Products or relating to requests regarding Licensed Products from any
Regulatory Authority in the Territory.
10.4 COVENANTS OF HYSEQ.
(a) No Debarment. In the course of the Development, manufacture and
Commercialization of Licensed Products and during the Term, Hyseq shall not
knowingly use and shall not have knowingly used any employee or consultant who
is or has been debarred by a Regulatory Authority or, to the best of Hyseq's
knowledge, is or has been the subject of debarment proceedings by a Regulatory
Authority.
(b) Compliance. Hyseq shall comply with all applicable statutes,
regulations and guidance of Regulatory Authorities in carrying out its
activities regarding the Development, manufacturing and Commercialization of
Licensed Products in the Territory.
(c) Diligence. Hyseq covenants that it shall use Commercially Reasonable
Efforts to carry out its obligations in accordance with the terms of this
License Agreement including, as applicable, the Development, manufacturing and
Commercialization of Licensed Products in the Territory in accordance with the
terms of this License Agreement. Without limiting the generality of the
foregoing obligation, Hyseq covenants that:
(i) Hyseq shall use Commercially Reasonable Efforts to administer
a Licensed Product to a patient in a government-approved clinical trial within
[***] after the Effective Date of the Collaboration Agreement. In the event
Hyseq fails to administer such Licensed Product in such time period then, within
[***] after the Effective Date, Hyseq shall either pay Amgen a [***] or Amgen
may terminate this License Agreement and Hyseq shall immediately return all
rights to Amgen.
(ii) Hyseq shall use Commercially Reasonable Efforts to administer
a Licensed Product to a patient in a government-approved clinical trial within
[***] after the Effective Date of the Collaboration Agreement. In the event
Hyseq fails to administer such Licensed Product in such time period then, in
addition to any payment that may have been due under subsection (i) above and
within [***] after the Effective Date, in addition to the payment in subsection
(i) above, Hyseq will either pay Amgen a [***] or Amgen may terminate this
License Agreement and Hyseq shall immediately return all rights to Amgen.
(iii) Hyseq shall use Commercially Reasonable Efforts to administer
a Licensed Product to a patient in a government-approved clinical trial within
[***] after the Effective Date of the Collaboration Agreement. In the event
Hyseq fails to administer such Licensed Product in such time period, then Amgen
shall have the right to terminate this License Agreement and Hyseq shall
immediately return all rights to Amgen.
(d) No Misappropriation. It shall not knowingly misappropriate the trade
secret of a Third Party in its activities to Develop, manufacture or
Commercialize Licensed Products.
10.5 DISCLAIMERS. EXCEPT AS EXPRESSLY PROVIDED HEREIN, THE MATERIALS AND
INFORMATION PROVIDED HEREUNDER ARE BEING PROVIDED "AS IS" AND WITHOUT ANY
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
19
REPRESENTATIONS OR WARRANTIES. NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, OF ANY TYPE WHATSOEVER REGARDING THE MATERIALS
AND INFORMATION. EACH PARTY EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY,
OF FITNESS FOR A PARTICULAR PURPOSE OR OF NONINFRINGEMENT.
ARTICLE 11
INDEMNIFICATION
11.1 INDEMNIFICATION BY AMGEN. Amgen hereby agrees to defend, hold
harmless and indemnify (collectively "Indemnify" or be "Indemnified") Hyseq and
its Affiliates, agents, directors, officers and employees (the "Hyseq
Indemnitees") from and against any and all Losses resulting directly or
indirectly from any Third Party claims, suits, actions or demands arising
directly or indirectly out of (a) any of Amgen's representations and warranties
set forth in this License Agreement being untrue in any material respect when
made and/or (b) any material breach or material default by Amgen of its
covenants and obligations under this License Agreement. To be eligible to be so
Indemnified as described in this Section 11.1, the Hyseq Indemnitees shall
provide Amgen with prompt notice of any claims, suits, actions or demands (with
a description of the claim and the nature and amount of any such Loss) giving
rise to the indemnification obligation pursuant to this Section 11.1 and the
exclusive ability to defend such claims, suits, actions or demands (with the
reasonable cooperation of Hyseq Indemnitees); provided however, that Amgen shall
be relieved of its obligations only if any failure by the Hyseq Indemnitee to
deliver prompt notice shall have been prejudicial to its ability to defend such
claims, suits, actions or demands. Hyseq shall have the right to retain its own
counsel, at its own expense, if representation of the counsel of Amgen would be
inappropriate due to actual or potential differing interests between the
Parties. Amgen shall not settle or consent to the entry of any judgment with
respect to any claim for Loss for which indemnification is sought [***]. Amgen's
obligation to Indemnify the Hyseq Indemnitees pursuant to this Section 11.1
shall not apply to the extent of any Losses (i) that arise from the [***] of any
Hyseq Indemnitee; (ii) that arise from Hyseq's material breach of any
representation, warranty, covenant or obligation under this License Agreement;
or (iii) for which Hyseq is obligated to Indemnify the Amgen Indemnitees
pursuant to Section 11.2 of this License Agreement.
11.2 INDEMNIFICATION BY HYSEQ. Hyseq hereby agrees to Indemnify Amgen and
its Affiliates, agents, directors, officers and employees (the "Amgen
Indemnitees") from and against any and all Losses arising from Third Party
claims, suits, actions or demands resulting directly or indirectly from (a) any
of Hyseq's representations and warranties set forth in this License Agreement
being untrue in any material respect when made; (b) the Development, manufacture
and Commercialization of Licensed Products by, on behalf of or under authority
of Hyseq, its Affiliates or its Sublicensees; and/or (c) any material breach or
material default by Hyseq of its covenants and obligations under this License
Agreement. To be eligible to be Indemnified as described above in this Section
11.2, the Amgen Indemnitees shall provide Hyseq with prompt notice of any
claims, suits, actions or demands (with a description of the claim and the
nature and amount of any such Loss) giving rise to the indemnification
obligation pursuant to this Section 11.2 and the exclusive ability to defend
such claims, suits, actions or demands (with the reasonable cooperation of Amgen
Indemnitees); provided however, that Hyseq shall be relieved of its obligations
only if any failure by the Amgen Indemnitee to deliver prompt notice shall have
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SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
20
been prejudicial to its ability to defend such claims, suits, actions or
demands. Amgen shall have the right to retain its own counsel, at its own
expense, if representation of the counsel of Hyseq would be inappropriate due to
actual or potential differing interests between the Parties. Hyseq shall not
settle or consent to the entry of any judgment with respect to any claim for
Loss for which indemnification is sought [***]. Hyseq's obligation to Indemnify
the Amgen Indemnitees pursuant to this Section 11.2 shall not apply to the
extent of any Losses (i) that arise from the [***] of any Amgen Indemnitee
(including but not limited to that arising from the manufacture of Licensed
Product by Amgen), (ii) that arise from any material breach by Amgen of any
representation, warranty, covenant or obligation under this License Agreement or
(iii) for which Amgen is obligated to Indemnify the Hyseq Indemnitees pursuant
to Section 11.1 of this License Agreement.
11.3 INSURANCE. Within thirty (30) days of the Effective Date, Hyseq
shall at its own expense procure and maintain an insurance policy/policies,
including product liability insurance (but excluding clinical trial insurance
policies which shall be required only while trials are ongoing), adequate to
cover its obligations hereunder and which is/are consistent with normal business
practices of prudent companies similarly situated. Hyseq may self-insure all or
part of any such obligation consistent with pharmaceutical industry practices
but Hyseq shall at all times maintain the following minimum Third Party
insurance coverage:
TYPE OF COVERAGE AMOUNT
---------------- ------
Commercial General Liability Insurance [***]
Product Liability Insurance [***]
Excess Liability Insurance [***]
Clinical Trial Liability Insurance [***]
▇▇▇▇▇▇▇'▇ Compensation [***]
Each insurance policy required by and procured by Hyseq under this Section 11.3
shall name Amgen as an additional insured. Such insurance shall not be construed
to create a limit of Hyseq's liability with respect to its indemnification
obligations under this Article 11. Hyseq shall provide Amgen with a copy of the
certificate of insurance or other evidence of such insurance and/or
self-insurance, upon request. Hyseq shall provide Amgen with written notice at
least thirty (30) days prior to the cancellation, non-renewal or material change
in such insurance or self-insurance which materially adversely affects the
rights of Amgen hereunder.
11.4 PRE-EFFECTIVE DATE LOSSES. In accordance with Section 16.12 of the
Collaboration Agreement, each Party shall retain its obligations for Losses
accrued under the Collaboration Agreement and this License Agreement shall not
release, waive, alter or otherwise modify the Parties' respective obligations
thereunder. Other than with respect to its obligation for Losses due under and
prior to the termination of the Collaboration Agreement, Hyseq shall not assume
or be liable for (pursuant to this License Agreement) any Losses for which Amgen
is
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SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
21
previously responsible, resulting from or arising in connection with the
Development, manufacture or Commercialization of Licensed Product on or prior to
the Effective Date.
11.5 LIMITATION OF LIABILITY. NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES
SHALL BE LIABLE FOR SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES,
WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE INCURRED BY
THE OTHER PARTY IN CONNECTION WITH THIS LICENSE AGREEMENT, INCLUDING BUT NOT
LIMITED TO DAMAGES MEASURING LOST PROFITS OR BUSINESS OPPORTUNITIES.
ARTICLE 12
TERM AND TERMINATION
12.1 TERM. This License Agreement shall become effective on the Effective
Date and shall remain in full force and effect, unless earlier terminated
pursuant to this Article 12, on a country-by-country basis until there is no
remaining Royalty payment obligation in any country. Upon the expiry of Hyseq's
obligation to pay Royalties under this License Argeement for a given Licensed
Product in a country, Hyseq shall have a fully paid, royalty free, unrestricted
license under the Amgen Technology and the Amgen Material and Manufacturing
Information to make, have made, use, sell, offer to sell, have sold, import,
export and otherwise exploit, transfer physical possession of and transfer title
or interest in or to such given Licensed Product in such country.
12.2 TERMINATION FOR CONVENIENCE. Hyseq may terminate this License
Agreement at any time by providing ninety (90) days prior written notice of
termination to Amgen.
12.3 TERMINATION BY AMGEN. In the event Hyseq shall not timely pay any
maintenance fees due pursuant to either Section 10.4(c)(i) or 10.4(c)(ii) or
shall not timely administer a Licensed Product to a patient pursuant to Section
10.4(c)(iii), Amgen shall have the sole right to terminate this License
Agreement by providing thirty (30) days prior written notification of
termination to Hyseq.
12.4 TERMINATION FOR DEFAULT.
(a) In the event any material representation or warranty made hereunder
or under the Warrant Purchase Agreement by either Party shall have been untrue
in any material respect ("Representation Default"), or upon any material breach
or material default of a material obligation of this License Agreement or the
Warrant Purchase Agreement (as defined in the Collaboration Agreement) by a
Party ("Performance Default"), the Party not in default ("Non-Defaulting Party")
must first give the other Party ("Defaulting Party") written notice thereof
("Notice of Default"), which notice must state the nature of the Representation
Default or Performance Default in reasonable detail and must request the
Defaulting Party cure such Representation Default or Performance Default within
sixty (60) days. During any such 60-day period after receipt or delivery of a
Notice of Default under this Section 12.4(a) for which termination of this
License Agreement, in whole or in part is a remedy, all of the Party's
respective rights and obligations under the affected parts of this License
Agreement, including but not limited to Development, manufacturing and
Commercialization, shall (to the extent applicable) remain in force and effect.
If the Defaulting Party shall dispute the existence, extent
22
or nature of any default set forth in a Notice of Default, the Parties shall use
good faith efforts to resolve the dispute.
(b) Hyseq. In the event of a Representation Default or a Performance
Default by Hyseq that shall not have been cured within the period set forth in
Section 12.4(a) above after receipt of a Notice of Default (or Hyseq shall not
have presented a reasonably achievable plan to cure such Default as promptly as
is reasonably practicable under the circumstances), Amgen, at its option, may
terminate this License Agreement upon sixty (60) days prior written notice,
unless such Representation Default is an unintentional Representation Default of
the Warranty Agreement and Amgen did not provide Notice of Default within one
(1) year after the Effective Date. In addition, in the event of termination
pursuant to such uncured Representation Default as provided in the foregoing
sentence, Amgen will be entitled to receive a refund of all money paid.
(c) Amgen. In the event of a Representation Default or a Performance
Default by Amgen that shall not have been cured within the period set forth in
Section 12.4(a) after receipt of a Notice of Default (or Amgen shall not have
presented a reasonably achievable plan to cure such Default as promptly as is
reasonably practicable under the circumstances), Hyseq, at its option, may
terminate this License Agreement upon sixty (60) days prior written notice. In
addition, in the event of termination pursuant to such uncured Representation
Default as provided in the foregoing sentence, Hyseq will be entitled to receive
a refund of all money paid.
12.5 BANKRUPTCY.
(a) Amgen may terminate this License Agreement if, during the term of
the Research Program, Hyseq shall file in any court or agency pursuant to any
statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the appointment of
a receiver or trustee of Hyseq or of its assets, or if Hyseq proposes a written
agreement of composition or extension of its debts, or if Hyseq shall be served
with an involuntary petition in bankruptcy or seeking reorganization,
liquidation, dissolution, winding-up arrangement, composition or readjustment of
its debts or any other relief under any bankruptcy, insolvency, reorganization
or other similar act or law of any jurisdiction now or hereafter in effect, or
there shall have been issued a warrant of attachment, execution, distraint or
similar process against it, filed in any insolvency proceeding, and such
petition shall not be dismissed within ninety (90) days after the filing
thereof, or if Hyseq shall propose or be a party to any dissolution or
liquidation, or if Hyseq shall make an assignment for the benefit of creditors.
(b) All rights and licenses granted under or pursuant to this License
Agreement by Amgen or Hyseq 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 of the U.S. Bankruptcy
Code. The Parties agree that each Party 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 a bankrupt Party under the U.S. Bankruptcy Code, the other Party shall
be entitled to a complete duplicate of (or complete access to, as appropriate)
any intellectual property and all embodiments of such intellectual property, and
same, if not already in the other Party's possession, shall be promptly
delivered to the other Party (a) upon any such commencement of a bankruptcy
proceeding, upon the other Party's written request therefor, unless the
non-bankrupt Party (or a trustee on behalf of
23
the non-bankrupt Party) elects to continue to perform all of its obligations
under this License Agreement or (b) if not delivered under (a) above, upon the
rejection of this License Agreement by or on behalf of the non-bankrupt Party,
upon written request therefor by the other Party.
12.6 EFFECTS OF TERMINATION. In addition to any other remedies which may
be available at law or equity upon termination of this License Agreement the
rights and obligations of the Parties shall be as set forth in this Section
12.6.
(a) The following provisions shall remain in full force and effect after
the expiration or termination of this License Agreement: Section 6.5 (solely
with respect to any ongoing possession or exchange of the other Party's
Confidential Information); Section 6.7; Article 7 (only with respect to accrued
rights and obligations pursuant to Section 12.7); Article 9 (Confidentiality);
Section 10.3(c), 10.5 (Disclaimers); Article 11 (Indemnification); Article 12
(Term and Termination); and Article 14 (General).
(b) The Parties shall retain their respective ownership rights as set
forth in Section 6.1(a). Amgen shall have the right, mutatis mutandis, to file,
prosecute, defend and maintain Joint Patent Rights under Section 6.2(b) (with
Hyseq having the right mutatis mutandis to comment with respect to the claims of
Joint Patent Rights not relating to products which may in any way affect the
rights conferred to Amgen to Develop, manufacture and Commercialize Licensed
Products) and Product Trademarks under Section 6.2(d), enforce Joint Patent
Rights under Section 6.3(b) (with Hyseq having the right mutatis mutandis to
assume any enforcement and/or defense action not taken by Amgen with respect to
the claims of Joint Patent Rights not relating to products which may in any way
affect the rights conferred to Amgen to Develop, manufacture and Commercialize
Licensed Products) and Product Trademarks under Section 6.3(c); and defend any
action claiming the infringement of any Third Party Patent Rights or any Third
Party Trademark under Section 6.4(a) and to publish under Article 8.
(c) Hyseq shall within thirty (30) days (other than with respect to
Amgen Material and Manufacturing Information, in which case by no later than
completion of its obligations, if any, under Section 12.6(g) below) destroy, or
at Amgen's request return, all Amgen Confidential Information, Amgen Know-How
and Amgen Material and Manufacturing Information (other than with respect to
maintaining one (1) archival copy of Confidential Information related thereto
for its legal files, for the sole purpose of determining its obligations
hereunder) and shall provide Amgen with certification by an officer of Hyseq
that all such materials have been returned to Amgen.
(d) Hyseq shall promptly transfer to Amgen ownership of all Regulatory
Filings and Regulatory Approvals then in its name for all Licensed Products and
shall notify the appropriate Regulatory Authorities and take any other action
reasonably necessary to effect such transfer of ownership. Hyseq shall assign to
Amgen Hyseq's right, title and interest in the Product Trademarks.
(e) Amgen shall have the right to use Hyseq's Trademarks in the selling
of any existing inventory of Licensed Product(s) and to use Promotional
Materials it then has on hand, provided however, that Amgen promptly creates new
Promotional Materials (which do not use Hyseq's corporate name and/or logo),
with no obligation of accounting to Hyseq.
24
(f) Hyseq shall within thirty (30) days (other than with respect to
Third Party agreements entered into pursuant to Section 6.8, in which case by no
later than completion of its obligations if any under Section 12.6(g) below), at
the request of Amgen, assign (if assignable under its terms) to Amgen all of
Hyseq's rights and obligations under any then-existing Third Party licenses
having a license grant limited specifically to Licensed Products, regarding the
making, having made, use, selling, offering to sell, and importing, exporting or
otherwise transferring physical possession of or otherwise transferring title in
or to Licensed Products and shall not (until receiving notice of whether or not
Amgen desires such an assignment) terminate or amend any such Third Party
license. Otherwise, Hyseq shall, at the request of Amgen, sublicense (if
sublicensable under its terms) to Amgen all of Hyseq's rights and obligations
under any then-existing Third Party licenses regarding the making, having made,
use, selling, offering to sell, and importing, exporting or otherwise
transferring physical possession of or otherwise transferring title in or to
Licensed Products and shall not (until receiving notice of whether or not Amgen
desires such a sublicense) terminate or amend any such Third Party license. Such
assignment or sublicense shall be made for no additional consideration and be
under the same terms and conditions as the underlying agreement.
(g) In the event Hyseq shall (i) have been using a Third Party contract
manufacturer(s) to manufacture Licensed Products, it shall only be obligated
with respect to the manufacture and supply of Licensed Products under this
License Agreement to assign its agreement with each such Third Party contract
manufacturer to Amgen or (ii) have been manufacturing Licensed Products at its
own facilities, it shall remain responsible for supplying the reasonable amounts
of Licensed Products for such reasonable period of time as to allow Amgen to
obtain an alternate source of supply, if necessary, while ensuring an
uninterrupted supply of Licensed Product of suitable quality and quantity
required for the Development and Commercialization to proceed. Once
manufacturing responsibility has been successfully transferred, Hyseq shall no
longer be responsible for the manufacture and supply of Licensed Products to
Amgen for the Development and Commercialization of Licensed Products in the
Territory and for making any decision with respect thereto and shall no longer
be responsible for any obligations pursuant to Article 4. In the event Hyseq is
obligated to continue to supply Licensed Products under this Section 12.6(g),
Amgen shall use Commercially Reasonable Efforts to identify one or more viable
Third Party manufacturers in order to transfer manufacturing operations as soon
as commercially reasonable.
(h) Amgen hereby agrees to Indemnify the Hyseq Indemnitees from and
against any and all Losses resulting from any Third Party claims, suits, actions
or demands resulting directly or indirectly from the Development, manufacture or
Commercialization of Licensed Products (including a claim that a Licensed
Product caused death or personal injury of any kind). To be eligible to be
Indemnified as described above in this Section 12.6(h), the Hyseq Indemnitees
shall provide Amgen with prompt notice of any claim (with a description of the
claim and the nature and amount of any such Loss) giving rise to the
indemnification obligation pursuant to this Section 12.6(h) and the exclusive
ability to defend such claim (with the reasonable cooperation of Hyseq
Indemnitees); provided however, that Amgen shall be relieved of its obligations
only if any failure by the Hyseq Indemnitee to deliver prompt notice shall have
been prejudicial to its ability to defend such action. Hyseq shall have the
right to retain its own counsel, at its own expense, if representation of the
counsel of Amgen would be inappropriate
25
due to actual or potential differing interests between the Parties. Neither
Party shall settle or consent to the entry of any judgment with respect to any
claim for Loss for which indemnification is sought, without the prior written
consent of the other Party (not to be unreasonably withheld). Amgen's obligation
to Indemnify the Hyseq Indemnitees pursuant to this Section 12.6(h) shall not
apply to the extent of any Losses (i) that arise from the negligence or
intentional misconduct of any Hyseq Indemnitee (including but not limited to
that arising from the Development of Collaboration Product by Hyseq); (ii) that
arise from Hyseq's breach of any representation, warranty, covenant or
obligation under this License Agreement; or (iii) for which Hyseq is obligated
to Indemnify the Amgen Indemnitees pursuant to Section 11.2 of this License
Agreement.
(i) In the event that Amgen becomes entitled to terminate this License
Agreement at any time after the First Commercial Sale, the Parties will mutually
agree upon the text of a press release announcing the termination of this
License Agreement. After a notice of termination has been delivered pursuant to
any one of Sections 12.2 to 12.4, Hyseq shall, in no event in excess of ninety
(90) days after the delivery date of such notice (other than with respect to
obligations which explicitly exceed such 90-day period), conduct an orderly
transition of rights and responsibilities from Hyseq to Amgen or to a Third
Party, as the case may be. Further, each Party shall cooperate and assist the
other Party to effect any such transition of rights and responsibilities in an
orderly, reasonable and businesslike manner. Such assistance shall include, but
not be limited to (i) making its personnel and other resources reasonably
available to Amgen, as necessary and (ii) transferring copies of all relevant
information, files or data containing Information and all Materials to Amgen.
(j) Except as expressly set forth in this Section 12.6, all other rights
and obligations shall terminate.
12.7 ACCRUED RIGHTS. Termination, relinquishment or expiration of any
licenses under this License Agreement or of this License Agreement for any
reason in accordance with this Article 12 shall be without prejudice to any
rights which shall have accrued to the benefit of either Party or any liability
incurred by either Party prior to the effective date of such termination,
relinquishment or expiration nor preclude either Party from pursuing all rights
and remedies it may have hereunder or at law or in equity with respect to any
breach of this License Agreement nor prejudice either Party's right to obtain
performance of any obligation.
ARTICLE 13
DISPUTE RESOLUTION
13.1 DISPUTES. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this License Agreement which
relate to either Party's rights and/or obligations hereunder. It is the
objective of the Parties to establish procedures to facilitate the resolution of
disputes arising from, concerning or in any way relating to this License
Agreement in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow the
procedures set forth in this Section 13.1 if and when a dispute arises under
this License Agreement. The Parties shall undertake good faith efforts to
resolve any such dispute in good faith. In the event the Parties shall be unable
to
26
resolve such dispute, either Party may, by written notice to the other Party,
have any dispute between the Parties referred to their respective executive
officers designated below )or their designees or successors) for attempted
resolution by good faith negotiations within fifteen (15) days after such notice
is received. Such designated officers are as follows:
FOR HYSEQ: HYSEQ'S GENERAL COUNSEL
FOR AMGEN: AMGEN'S GENERAL COUNSEL
If the designated officers are not able to resolve such dispute
within such fifteen (15) day period, the dispute will be referred to the
respective Chief Executive Officers of each Party (or their respective Senior
Vice President designee(s)). If the Chief Executive Officers (or their
designees) are unable to resolve such dispute within a further fifteen (15) day
period, either Party may at any time thereafter pursue any legal or equitable
remedy available to it. Notwithstanding the above, either Party shall be
entitled at all times and without delay to seek equitable relief.
13.2 GOVERNING LAW; JUDICIAL RESOLUTION. Resolution of all disputes
arising out of or related to this License Agreement, or the performance,
enforcement, breach or termination of this License Agreement and any remedies
relating thereto, shall be governed by and construed under the substantive laws
of the State of California as applied to agreements executed and performed
entirely in the State of California by residents of the State of California,
without regard to conflicts of law rules. Any dispute arising under this License
Agreement shall be submitted to a state or federal court of competent
jurisdiction in California; provided however, that if Amgen is the initiating
Party in a dispute, its shall bring such suit in a state or federal court which
has jurisdiction over Sunnyvale, California; and if Hyseq is the initiating
Party in a dispute, its shall bring such suit in a state or federal court which
has jurisdiction over Thousand Oaks, California.
13.3 PATENT AND TRADEMARK DISPUTE RESOLUTION. Notwithstanding the above
Section 13.2, as between the Parties, any dispute, controversy or claim relating
to the scope, validity, enforceability or infringement of any Amgen Patent
Rights or Joint Patent Rights or of any Product Trademark shall be submitted to
a court of competent jurisdiction in the Territory in which such Patent Rights
or Trademark rights were granted or arose. Notwithstanding the foregoing, any
dispute, controversy or claim relating to the scope, validity, enforceability or
infringement of any United States patent application or patent within Amgen
Patent Rights or Joint Patent Rights shall be submitted to a court of competent
jurisdiction in the State of California.
ARTICLE 14
GENERAL
14.1 FORCE MAJEURE. Both Parties shall be excused from the performance of
their obligations under this License Agreement to the extent that such
performance is prevented by Force Majeure and the nonperforming Party promptly
provides notice of the prevention to the other Party. Such excuse shall be
continued so long as the condition constituting Force Majeure continues and the
nonperforming Party uses reasonable efforts to remove the condition. When
27
such circumstances arise, the Parties shall discuss what, if any, modification
of the terms of this License Agreement may be required in order to arrive at an
equitable solution.
14.2 NOTICES. Any notice required or permitted to be given under this
License Agreement shall be in writing, shall specifically refer to this License
Agreement and shall be deemed to have been sufficiently given for all purposes
if mailed by first class certified or registered mail, postage prepaid, express
delivery service or personally delivered or, if sent by facsimile, electronic
transmission is confirmed. Unless otherwise notified in writing, the mailing
addresses and fax numbers for notice of the Parties shall be as described below.
For Hyseq: Hyseq, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇.
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Phone: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attn: General Counsel
With a copy to: Chief Financial Officer
For Amgen: Amgen Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Vice President, Licensing
With a copy to: Corporate Secretary
14.3 MAINTENANCE OF RECORDS. Each Party shall keep and maintain all
records required by law or regulation with respect to Licensed Products and
shall make copies of such records available to the other Party upon request.
14.4 NO STRICT CONSTRUCTION. This License Agreement has been prepared
jointly and shall not be strictly construed against either Party.
14.5 ASSIGNMENT. Other than as set forth in Sections 2.3 or 14.6, neither
Party may assign or transfer this License Agreement or any rights or obligations
hereunder without the prior written consent of the other, except that a Party
may make such an assignment without the other Party's consent to Affiliates or
to an entity that acquires all or substantially all of the business of such
Party, whether in a merger, consolidation, reorganization, acquisition, sale or
otherwise. This License Agreement shall be binding on the successors and assigns
of the assigning Party, and the name of a Party appearing herein shall be deemed
to include the name(s) of such Party's successors and permitted assigns to the
extent necessary to carry out the intent of this License Agreement. Any
assignment or attempted assignment by either Party in violation of the terms of
this Section 14.5 shall be null and void and of no legal effect. The assigning
Party shall forward to the other Party a copy of those portions of each fully
executed assignment agreement which
28
relate to the assumption of the rights and responsibilities of the assigning
Party, within sixty (60) days of the execution of such assignment agreement.
14.6 PERFORMANCE BY AFFILIATES. Each of Amgen and Hyseq acknowledge that
obligations under this License Agreement may be performed by Affiliates of Amgen
and Hyseq. Each of Amgen and Hyseq guarantee performance of this License
Agreement by its Affiliates, notwithstanding any assignment to Affiliates in
accordance with Section 14.5 of this License Agreement. Wherever in this License
Agreement the Parties delegate responsibility to Affiliates or local operating
entities, the Parties agree that such affiliates/entities may not make decisions
inconsistent with this License Agreement, nor amend the terms of this License
Agreement or act contrary to its terms in any way. Hyseq shall forward to Amgen
a copy of each fully executed license or sublicense agreement, within sixty (60)
days of the execution of each such license or sublicense agreement.
14.7 COUNTERPARTS. This License Agreement may be executed in two (2) or
more counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
14.8 SEVERABILITY. If any one or more of the provisions of this License
Agreement are held to be invalid or unenforceable by any court of competent
jurisdiction from which no appeal can be or is taken, such provisions shall be
considered severed from this License Agreement and shall not serve to invalidate
any remaining provisions hereof. The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this License
Agreement, as evidenced by the terms of this License Agreement in accordance
with Section 14.16, may be realized.
14.9 HEADINGS. The headings for each Article and Section in this License
Agreement have been inserted for convenience of reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular Article or Section. Unless otherwise specified, (a) references in
this License Agreement to any Article, Section or Exhibit shall mean references
to such Article, Section or Exhibit of this License Agreement, (b) references in
any Section to any clause are references to such clause of such Section, and (c)
references to any agreement, instrument or other document in this License
Agreement refer to such agreement, instrument or other document as originally
executed or, if subsequently varied, replaced or supplemented from time-to-time,
as so varied, replaced or supplemented and in effect at the relevant time of
reference thereto.
14.10 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
License Agreement.
14.11 INDEPENDENT CONTRACTORS. The relationship between Hyseq and Amgen
created by this License Agreement is one of independent contractors. This
License Agreement does not create any agency, distributorship,
employee-employer, partnership, joint venture or similar business relationship
between the parties. Neither Party is a legal representative of the other Party,
and neither Party can assume or create any obligation, representation, warranty
or
29
guarantee (express or implied) on behalf of the other Party for any purpose
whatsoever. Each Party shall use its own discretion and shall have complete and
authoritative control over its employees and the details of performing its
obligations under this License Agreement.
14.12 NO BENEFIT OF THIRD PARTIES. The representations, warranties,
covenants and agreements set forth in this License Agreement are for the sole
benefit of the Parties hereto and their successors and permitted assigns, and
they shall not be construed as conferring any rights on any Third Parties.
14.13 USE OF NAME. Except as expressly provided in this License Agreement,
no Party hereto shall use, and no rights are granted in or to, the names or
Trademarks (including the names "Amgen" and "Hyseq"), physical likeness,
employee names or owner symbol of the other Party for any purpose (including,
without limitation, private or public securities placements) without the prior
written consent of the affected Party, such consent not to be unreasonably
withheld or delayed so long as such use of name is limited to an objective
statement of fact rather than for endorsement purposes. Neither Party shall use
any Trademark which either substantially resembles or is confusingly similar to,
misleading or deceptive with respect to, or which dilutes any of the other
Party's Trademarks in connection with the subject matter of this License
Agreement.
14.14 NO WAIVER. Any delay in enforcing a Party's rights under this
License Agreement or any waiver as to a particular default or other matter shall
not constitute a waiver of such Party's rights to the future enforcement of its
rights under this License Agreement, except with respect to an express written
and signed waiver relating to a particular matter for a particular period of
time.
14.15 EXPORT REQUIREMENTS. It is understood and acknowledged that the
transfer of certain commodities and technical data is subject to United States
laws and regulations controlling the export of such commodities and technical
data, including all Export Administration Regulations of the United States
Department of Commerce. Each Party hereby agrees and by entering into this
License Agreement gives written assurance that it shall comply with all United
States laws and regulations controlling the export of commodities and technical
data within Information and Materials, that it will be solely responsible for
any violation of any such laws and regulations by itself, its Affiliates or its
Sublicensees, and that it will indemnify, defend and hold the other Party
harmless from any liability in the event of any legal action of any nature
occasioned by such violation, pursuant to Section 11.1 (in the case of Amgen) or
Section 11.2 (in the case of Hyseq).
14.16 ENTIRE AGREEMENT; AMENDMENT. This License Agreement (including all
Exhibits); that certain Warrant Purchase Agreement, dated January 8, 2002; and
any rights and obligations surviving, by its terms, termination of that certain
Collaboration Agreement (as defined herein on Page 1) set forth the complete,
final and exclusive agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties
hereto and supersedes and terminates all prior agreements and understandings
between the Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings (either oral or written) between
the Parties other than as are set forth herein and therein. This License
Agreement may only be modified or
30
supplemented in a writing expressly stated for such purpose and signed by an
authorized officer of each Party (i.e., it may not be modified by any purchase
order, change order, acknowledgment, order acceptance, standard terms of sale,
invoice or the like).
14.17 EXHIBITS. All Exhibits referenced herein and attached hereto are
incorporated in this License Agreement by reference.
31
IN WITNESS WHEREOF, the Parties have executed this License Agreement in
duplicate originals by their duly authorized representatives as of the Effective
Date.
AMGEN INC. HYSEQ, INC.
(D.B.A. HYSEQ PHARMACEUTICALS)
By:___________________________________ By:___________________________________
Print Name:___________________________ Print Name:___________________________
Title:________________________________ Title:________________________________
32
EXHIBIT A
DEFINED TERMS
A.1 "AFFILIATE" shall mean, except as provided below, an individual, a
partnership, a joint venture, a corporation, a trust, an estate, an
unincorporated organization, a government or any department or agency thereof,
or any other entity or any combination of the aforementioned entities that,
directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with Amgen or Hyseq. For purposes of
this definition, "control" shall mean the possession, direct or indirect, of the
power to cause the direction of the management and policies of a Party, whether
through ownership of more than fifty percent (50%) of the voting securities of
such Party, by contract or otherwise.
A.2 "ALFIMEPRASE" shall mean the polypeptide having the amino acid
sequence which is set forth in Exhibit B.
A.3 "AMGEN KNOW-HOW" shall mean all Information and Material Controlled
by Amgen prior to or on the Effective Date necessary to Develop, manufacture or
Commercialize Licensed Products, including but not limited to the following
information: (1) information disclosed in the IND for Alfimeprase as of the
Effective Date; (2) information disclosed as of the Effective Date in any IND
supplements for Alfimeprase; (3) all Amgen-sponsored collaborator data and
results (subject to any contractual confidentiality obligations of Amgen to
Third Parties regarding such results); (4) any regulatory data which Amgen
provides to Hyseq; (5) sequence information of other Licensed Products and
information regarding their activity; and (6) such information which Amgen
expressly designates in writing it intends to include as Amgen Know-How under
this License Agreement; provided however, that Amgen Know-How shall exclude
Amgen Material and Manufacturing Information.
A.4 "AMGEN MATERIAL AND MANUFACTURING INFORMATION" shall mean the most
current version of (i) the Materials (other than Licensed Products); and (ii)
the Information pertaining to the manufacture of Licensed Products including,
without limitation, Information contained in the CMC section of any applicable
Regulatory Filings or Information regarding Amgen's manufacturing facility; and
(iii) Information regarding the Materials.
A.5 "AMGEN PATENT RIGHTS" shall mean Amgen's rights in (a) those Patent
Rights Controlled by Amgen on the Effective Date with respect to the Licensed
Products and listed in Exhibit C and (b) all Patent Rights Controlled by Amgen
prior to or during the term of the License Agreement that claim Amgen Know-How.
A.6 "AMGEN TECHNOLOGY" shall mean all Amgen Patent Rights and Amgen
Know-How and Amgen's interest in the Joint Patent Rights and Joint Know-How.
A.7 "ASIAN COUNTRIES" shall mean one or more of the following:
Bangladesh, Cambodia, India, Indonesia, Japan, Laos, Malaysia, Myanmar, Nepal,
North Korea, Pakistan, Peoples Republic of China (including Hong Kong and
Macao), Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand and
Vietnam.
A-1
A.8 "CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on either March 31, June 30, September 30, or
December 31 for so long as this License Agreement is in effect.
A.9 "CALENDAR YEAR" means each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
A.10 "COMMERCIALIZE" OR "COMMERCIALIZATION" shall mean all activities
relating to the manufacturing, promotion, and other pre-launch and post-launch
marketing and sale activities of Licensed Products and shall include without
limitation, Phase IV clinical trials (as defined in the Collaboration Agreement)
or equivalent clinical trials conducted following Regulatory Approval to market
such Licensed Product.
A.11 "COMMERCIALLY REASONABLE EFFORTS" shall mean the level of efforts
and resources required to Develop, manufacture or Commercialize a Licensed
Product in a sustained manner consistent with the efforts a similarly situated
biopharmaceutical company would typically devote to a product of similar market
potential, profit potential or strategic value resulting from its own research
efforts, based on conditions then prevailing. Commercially Reasonable Efforts
shall be determined on a country-by-country (each country including its
territories) basis for a particular Licensed Product, and it is anticipated that
the level of effort will change over time reflecting changes in the status of
the Licensed Product and the country (including its territories) involved.
A.12 "COMPETITIVE PRODUCT" shall mean any pharmaceutical product, other
than a Licensed Product, that contains (a) Alfimeprase or (b) any fibrinolytic
metalloproteinase product which has, incorporates or contains the following
properties: (i) is [***], (ii) does not require the involvement of the [***],
and (iii) is complexed by [***].
A.13 "CONFIDENTIAL INFORMATION" shall mean all Information received by
either Party from the other Party pursuant to this License Agreement, other than
that portion of such Information which:
(a) is publicly disclosed by the disclosing Party, either before
or after it becomes known to the receiving Party;
(b) was known to the receiving Party, without obligation to keep
it confidential, prior to when it was received from the
disclosing Party;
(c) is subsequently disclosed to the receiving Party by a Third
Party lawfully in possession thereof without obligation to
keep it confidential;
(d) has been publicly disclosed other than by the disclosing Party
and without breach of an obligation of confidentiality with
respect thereto; or
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
A-2
(e) has been independently developed by the receiving Party
without the aid, application or use of Confidential
Information, as demonstrated by competent written proof.
A.14 "CONTROL" OR "CONTROLLED" shall mean possession of the ability to
grant a license or sublicense as provided for herein under such intellectual
property right without violating the terms of any agreement or other arrangement
with any Third Party.
A.15 "DEVELOPMENT" OR "DEVELOP" shall mean all research, pre-clinical,
process development/manufacturing and clinical activities undertaken for a
Licensed Product required to successfully complete Pivotal Trials in the
Territory. For the avoidance of doubt, these activities shall include clinical
drug development activities, including among other things: test method
development and stability testing, toxicology, formulation, statistical analysis
and report writing, product approval and registration, and regulatory affairs
related to the foregoing. When used as a verb, "Develop" means to engage in
Development.
A.16 "DOLLAR" shall mean a United States dollar, and "$" shall be
interpreted accordingly.
A.17 "DRUG APPROVAL APPLICATION" shall mean an application for Regulatory
Approval required before commercial sale or use of a Licensed Product as a drug
or to treat a particular indication in a regulatory jurisdiction, including
without limitation: (a) (i) a Biologics License Application (BLA) pursuant to 21
C.F.R. 601.2, submitted to the FDA, or any successor application or procedure
and (ii) any counterpart of a U.S. BLA in another country in the Territory; and
(b) all supplements and amendments, including supplemental BLAs (and any foreign
counterparts), that may be filed (e.g., to expand the label) with respect to the
foregoing.
A.18 "FDA" shall mean the United States Food and Drug Administration, or
any successor thereto.
A.19 "FIRST COMMERCIAL SALE" shall mean the initial transfer by Hyseq or
its Affiliates or Sublicensees under this License Agreement of a Licensed
Product to a non-Sublicensee Third Party in exchange for cash or some equivalent
to which value can be assigned for the purpose of determining Net Sales,
following Regulatory Approval to market such Licensed Product.
A.20 "FORCE MAJEURE" shall mean any occurrence beyond the reasonable
control of a Party that prevents or substantially interferes with the
performance by such Party of any of its obligations hereunder, if such occurs by
reason of any act of God, flood, fire, explosion, earthquake, breakdown of
plant, shortage of critical equipment, loss or unavailability of manufacturing
facilities or material, strike, lockout, labor dispute, casualty or accident, or
war, revolution, civil commotion, acts of public enemies, blockage or embargo,
or any injunction, law, order, proclamation, regulation, ordinance, demand or
requirement of any government or of any subdivision, authority or representative
of any such government, inability to procure or use materials, labor, equipment,
transportation, or energy sufficient to meet manufacturing needs without the
necessity of allocation, or any other cause whatsoever, whether similar or
dissimilar to those above enumerated, beyond the reasonable control of such
Party, if and only if the Party affected shall have used reasonable efforts to
avoid such occurrence and to remedy it promptly if it shall have occurred.
A-3
A.21 "GAAP" shall mean United States generally accepted accounting
principles.
A.22 "IND" shall mean an Investigational New Drug application.
A.23 "INFORMATION" shall mean all tangible and intangible techniques,
technology, practices, trade secrets, inventions (whether patentable or not),
methods, knowledge, know-how, conclusions, skill, experience, test data and
results (including pharmacological, toxicological and clinical test data and
results), analytical and quality control data, results or descriptions, software
and algorithms.
A.24 "JOINT KNOW-HOW" shall mean Information and Materials characterized,
conceived, developed, derived, generated or identified jointly by employees of
or consultants to Hyseq and employees of or consultants to Amgen from the
Effective Date through the Term.
A.25 "JOINT PATENT RIGHTS" shall mean all Patent Rights that claim or
disclose Joint Know-How.
A.26 "LICENSED PRODUCT(s)" shall mean (a) Alfimeprase or (b) any
fibrinolytic metalloproteinase product which is owned or Controlled by Amgen
and/or Hyseq and which has, incorporates or contains the following properties:
(i) is [***], (ii) does not require the involvement of the [***], and (iii) is
complexed by [***].
A.27 "LOSSES" shall mean liabilities, costs, fees, expenses and/or
losses, including without limitation reasonable legal costs and expenses and
attorneys' fees for outside counsel.
A.28 "MATERIALS" shall mean certain biological materials including, but
not limited to, Licensed Products, screens, animal models, cell lines, cells,
nucleic acids, receptors and reagents.
A.29 "NET SALES" shall mean all revenues recognized in accordance with
GAAP from the sale or other disposition of Licensed Products by Hyseq or its
Affiliates or Sublicensees to a non-Sublicensee Third Party after deducting
returns and allowances (actually paid or allowed) including, but not limited to,
prompt payment and volume discounts, price reductions, including Medicaid and
similar types of rebates, chargebacks from wholesalers of Licensed Products
(whether in cash or trade), freight, shipping, packing, insurance, rebates, and
sales and other taxes based on sales prices when included in gross sales, but
not including taxes when assessed on income derived from such sales. Amounts
received by Hyseq or its Affiliates for the sale of Licensed Products among
Hyseq or its Affiliates for resale or for transfer of Licensed Products to a
Sublicensee for resale shall not be included in the computation of Net Sales
hereunder.
A.30 "PATENT RIGHTS" shall mean (i) a pending application for a patent,
including without limitation any provisional, converted provisional, continued
prosecution application, continuation, divisional or continuation-in-part
thereof; or (ii) an issued, unexpired patent (with the term "patent" being
deemed to encompass, without limitation, an inventor's certificate) which has
not been held invalid or unenforceable by a court of competent jurisdiction from
which no appeal can be taken or has been taken within the required time period,
including without limitation any substitution, extension, registration,
confirmation, reissue, re-examination, renewal or any like filing thereof.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
A-4
A.31 "PIVOTAL TRIAL(S)" shall mean those clinical trials on sufficient
numbers of patients that, if the defined end-points are met, are designed (and
agreed to by the FDA, or other Regulatory Authorities in the Territory based
upon existing data in the same patient population) as of the start of the trial
to definitively establish that a drug is safe and efficacious for its intended
use, and to define warnings, precautions and adverse reactions that are
associated with the drug in the dosage range to be prescribed, and provide
pivotal data supporting Regulatory Approval of such drug or label expansion of
such drug and that satisfy the requirements of 21 CFR 321.21(c) (or its
successor regulation), or an equivalent foreign clinical trial.
A.32 "PRODUCT TRADEMARK" shall mean any trademarks and trade names (and
trademark applications (whether or not registered) together with all goodwill
associated therewith, and any renewals, extensions or modifications thereto in
the Territory), trade dress and packaging which (a) are owned by or Controlled
by either Party and (b) are applied to or used with Licensed Products or any
Promotional Materials.
A.33 "PROMOTIONAL MATERIALS" shall mean all sales representative training
materials and all written, printed, graphic, electronic, audio or video matter
including, but not limited to, journal advertisements, sales visual aids, direct
mail, direct-to-consumer advertising, Internet postings, broadcast
advertisements, and sales reminder aids (e.g., scratch pads, pens and other such
items) intended for use or used by a Party in connection with any Promotion (as
defined herein) or Detailing (as defined in the Collaboration Agreement) of a
Licensed Product, except for (i) the Regulatory Authority-approved full
prescribing information for a Licensed Product, including any required patient
information and (ii) all labels and other written, printed or graphic matter
upon any container, wrapper, or any package insert or outsert utilized with or
for a Licensed Product.
A.34 "REGULATORY APPROVAL" shall mean any approvals (including
supplements, amendments, pre- and post-approvals and price approvals), licenses,
registrations or authorizations (including designations of a Licensed Product as
an "Orphan Product" under the Orphan Drug Act) of any national, supra-national,
regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity, including the FDA or equivalent foreign
Regulatory Authorities, necessary for the distribution, use or sale of a
Licensed Product in a regulatory jurisdiction. Regulatory Approval shall not
include any site license for an Amgen manufacturing facility.
A.35 "REGULATORY AUTHORITY" shall mean the FDA or any counterpart of the
FDA outside the United States.
A.36 "REGULATORY FILINGS" shall mean collectively, INDs, BLAs,
establishment license applications (ELAs) and drug master files (DMFs),
applications for designation of a Licensed Product as an "Orphan Product" under
the Orphan Drug Act, or any other similar filings (including any foreign
equivalents and further including any related correspondence and discussions),
and all data contained therein, as may be required by the FDA or equivalent
foreign Regulatory Authorities for the Development, manufacture or
Commercialization of a Licensed Product.
A-5
A.37 "ROYALTY" OR "ROYALTIES" shall mean those amounts payable as
royalties by Hyseq to Amgen pursuant to Section 5.2 of this License Agreement.
A.38 "SUBLICENSEE" shall mean a Third Party to whom Hyseq shall have
granted a license or sublicense under Hyseq's rights pursuant to Section 2.3 to
make, have made, use, sell, offer for sale, or import a Licensed Product in one
or more countries in the Territory. Solely for the purpose of any compensation
payable to Amgen hereunder, "Sublicensee" shall include a Third Party to whom
Hyseq or another Sublicensee shall have granted the right to distribute one or
more Licensed Product(s), wherein such distributor pays to Hyseq or such another
Sublicensee a royalty based upon the revenues received by the distributor for
the sale of such Licensed Product(s), but shall not include (i) any Third Party
who receives an implied license to use a unit of Licensed Product(s), arising by
operation of law, as a consequence of the purchase of said unit of Licensed
Product(s); or (ii) any Third Party where Hyseq or such another Sublicensee
merely sells such Licensed Product(s) at a fixed transfer price to such
distributor for resale by such distributor and Hyseq is not compensated based on
the resale price of such Licensed Product by such distributor.
A.39 "TERM" shall have the meaning set forth in Section 12.1.
A.40 "TERRITORY" shall mean the world.
A.41 "THIRD PARTY" shall mean any individual, a partnership, a joint
venture, a corporation, a trust, an estate, an unincorporated organization, a
government or any department or agency thereof, or any other than Amgen or Hyseq
or an Affiliate of either of them.
A.42 "THIRD PARTY PAYMENT" shall mean all upfront payments, milestone
payments, license fees, royalties or other payments, payable to any Third Party
under any Third Party license agreement deemed necessary or useful to make, have
made, use, sell, offer to sell, and import, export or otherwise transfer
physical possession of or otherwise transfer title in a Licensed Product.
A.43 "TRADEMARK" shall mean any and all corporate names, trade names,
service marks, logos or trademarks and trademark applications (whether or not
registered) together with all good will associated therewith, and any renewals,
extensions or modifications thereto either filed or used.
A.44 "VALID CLAIM" shall mean (i) an unexpired claim of an issued patent
within the Amgen Patent Rights and Joint Patent Rights that has not been found
to be unpatentable, invalid or unenforceable by a court or other authority in
the country of the patent, from which decision no appeal is taken or can be
taken; or (ii) a claim of a pending application within the Amgen Patent Rights
and Joint Patent Rights, wherein such pending application claims a first
priority no more than [***] prior to the date upon which pendency is determined.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
A-6
EXHIBIT B
PROTEIN SEQUENCE OF ALFIMEPRASE
RN 259074-76-5 ZREGISTRY
CN 3-203-Fibrolase [3-serine] (Agkistrodon contortrix contortrix recombinant)
(9CI) (CA INDEX NAME)
FS PROTEIN SEQUENCE
SQL 201
NTE
----------------------------------------------------------------------
type ------ location ------ description
----------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇-▇▇▇ - ▇▇▇-▇▇▇ disulfide bridge
bridge ▇▇▇-▇▇▇ - ▇▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇-▇▇▇ - ▇▇▇-▇▇▇ disulfide bridge
----------------------------------------------------------------------
SEQ 1 SFPQRYVQLV IVADHRMNTK YNGDSDKIRQ WVHQIVNTIN EIYRPLNIQF
▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
101 DFDGDTVGLA YVGGMCQLKH STGVIQDHSA INLLVALTMA HELGHNLGMN
151 HDGNQCHCGA NSCVMAAMLS DQPSKLFSDC SKKDYQTFLT VNNPQCILNK
201 P
SEQ3 1 Ser-Phe-Pro-Gln-Arg-Tyr-Val-Gln-Leu-Val-
11 ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
▇▇ ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
31 Trp-Val-His-Gln-Ile-Val-Asn-Thr-Ile-Asn-
41 Glu-Ile-Tyr-Arg-Pro-Leu-Asn-Ile-Gln-Phe-
51 Thr-Leu-Val-Gly-Leu-Glu-Ile-Trp-Ser-Asn-
61 Gln-Asp-Leu-Ile-Thr-Val-Thr-Ser-Val-Ser-
71 His-Asp-Thr-Leu-Ala-Ser-Phe-Gly-Asn-Trp-
81 ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
▇▇ ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
101 Asp-Phe-Asp-Gly-Asp-Thr-Val-Gly-Leu-Ala-
111 ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
▇▇▇ ▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-▇▇▇-
131 Ile-Asn-Leu-Leu-Val-Ala-Leu-Thr-Met-Ala-
141 His-Glu-Leu-Gly-His-Asn-Leu-Gly-Met-Asn-
151 His-Asp-Gly-Asn-Gln-Cys-His-Cys-Gly-Ala-
161 Asn-Ser-Cys-Val-Met-Ala-Ala-Met-Leu-Ser-
171 Asp-Gln-Pro-Ser-Lys-Leu-Phe-Ser-Asp-Cys-
181 Ser-Lys-Lys-Asp-Tyr-Gln-Thr-Phe-Leu-Thr-
191 Val-Asn-Asn-Pro-Gln-Cys-Ile-Leu-Asn-Lys-
201 Pro
B-1
EXHIBIT C
AMGEN PATENT RIGHTS AS OF THE EFFECTIVE DATE
C-1