Exhibit 10.1

 

EXPANDED ACCESS PROGRAM (EAP) MASTER SERVICES AGREEMENT

 

This EAP MASTER SERVICES AGREEMENT (together with any Statements of Work (as
defined in Section 1), the “Agreement”) is effective this 30th day of May 2020
(“Effective Date”) by and between Mateon Therapeutics INC., a Delaware
corporation with its principal office at 29397 Agoura Rd., Suite 107, Agoura
Hills, CA 91301, USA (“Mateon”) and IMPATIENTS N.V., acting under the trade name
myTomorrows, a company formed and registered under the laws of The Netherlands,
and located at Anthony Fokkerweg 61, 1059 CP, Amsterdam, The Netherlands
(“Impatients”).

 

1. Agreement Structure. From time to time, Mateon may request that Impatients
provide certain Expanded Access Program related activities with respect to the
Product on behalf of Mateon (“Services”). This Agreement contains general terms
and conditions under which Mateon would engage Impatients and under which
Impatients would provide Services.

 

  1.1. Statements of Work. The Services will be defined in one or more
statements of work referencing this Agreement (each, a “Statement of Work”)
before any Services are provided. Neither Mateon nor Impatients is obligated to
execute any Statement of Work. Once executed, each Statement of Work becomes
part of this Agreement, although the terms in a Statement of Work will apply
only to Services described in that Statement of Work. A Statement of Work may
not change any term in this Agreement.

 

2. Definitions. The following terms when used in this Agreement, shall the have
meanings set forth in this Section:

 

  2.1. “Affiliate” means, as to any person or entity, any other person or
entity, which controls, is controlled by, or is under common control with such
person or entity. A person or entity shall be regarded as in control of another
entity only if it owns or controls, directly or indirectly, at least fifty
percent (50%) of the equity securities or other ownership interests in the
subject entity entitled to vote in the election of directors or with the power
to direct or elect management of such subject entity.         2.2. “Applicable
Laws” means any international, US, EU, national, local, regional or provincial
laws, regulations, ordinances, regulatory guidance, guidelines or other
requirements of the Regulatory Authorities, including but not limited to
Directive 2001/83/EC (“Medicinal Products for Human Use Directive”), Commission
Directive 2005/28/EC (“GCP Directive”), Regulation (EU) 2016/679 (“GDPR”), the
United States Foreign Corrupt Practices Act, the UK Bribery Act 2010 and the
OECD Anti-Bribery Convention and any applicable national laws, regulations and
guidance, as amended from time to time.         2.3. “Business Day” means any
calendar day other than a Saturday, Sunday or any official holiday in the
Netherlands.         2.4. “Expanded Access Approvals” means the permissions,
exemptions, approvals, authorizations and/or waivers required by Regulatory
Authorities for medical treatments, not the subject of a Marketing
Authorization, to be provided to a pharmacy or wholesale or to be delivered to a
physician, as the case may be, in any applicable country in the Territory, to be
administered to and/or used by a patient.

 

 

 

 

  2.5. “Expanded Access Program” or “EAP” means the activities required to
enable Expanded access to investigational medical treatments and for the
collection and analysis of RWD (as defined below). This includes activities
directed to (i) the education of physicians regarding the possibility of
Expanded access to investigational medical treatments that are not yet the
subject of a Marketing Authorization through named-patient use, hospital
exemption or compassionate use, (ii) patient enrollment, (iii) the securing of
Expanded Access Approvals, for the use of such treatments, (iv) the collection
and analysis of patient level data for research purposes, (v) pharmacovigilance
registration and/or (vi) the collection of data, including but not limited to
patient-reported outcomes and doctor-reported experiences.         2.6. “Field”
means the treatment of COVID-19 patients with hypoxemic respiratory failure    
      for whom there are no appropriate alternative therapies.         2.7.
 “Good Manufacturing Practice” or “GMP” means the current good manufacturing
practices applicable from time to time to the manufacturing of a Product or any
intermediate thereof pursuant to Applicable Laws.         2.8. “Marketing
Authorization” or “MA” means all approvals from the relevant Regulatory
Authority necessary to place a pharmaceutical Product on the market in a country
or region.         2.9. “Manufacturer” means the legal entity that physically
manufactures and/or fills and/or finishes and/or labels and/or stockpiles cGMP
grade Product.         2.10. “Product” means the product referred to as TGF-β
inhibitor OT-101, that is supplied, ready packed and labelled, quality tested
and QP released in accordance with applicable pharmaceutical laws and
regulations.         2.11. “Real World Data” or “RWD” means data relating to
patient health status and/or the delivery of health care routinely collected
from a variety of sources.         2.12. “Real World Evidence” or “RWE” means
the clinical evidence about the usage and potential benefits or risks of a
medical product derived from analysis of RWD.         2.13. “Regulatory
Authority” means any applicable supra-national, federal, national, regional,
state, provincial, or local governmental or regulatory authority, agency,
department, bureau, commission, council or other entities (e.g., FDA, EMA and
PMDA) regulating or otherwise exercising authority with respect to activities
contemplated under this Agreement.         2.14.  “Territory” means the United
States of America.

 

3. Performance of the Services.

 

  3.1. Provision of Services. Impatients agrees to provide all Services
identified in any Statement of Work: (a) within the time specified in the
relevant Statement of Work (if applicable); and (b) in accordance with the terms
of this Agreement and any Applicable Laws.

 

 

 

 

  3.2. Subcontracting. Impatients may subcontract the performance of specific
obligations of Impatients under a Statement of Work to an Affiliate of
Impatients or to a qualified non-affiliate third party, including consultants
(collectively “Subcontractors”); provided, that (a) such Subcontractor performs
those Services in accordance with the Applicable Laws and in a manner consistent
with the terms and conditions of this Agreement; and (b) Impatients remains
liable for the performance of such Subcontractor.         3.3. Audits.
Impatients will allow representatives of regulatory agencies, with reasonable
advance notice and during normal business hours of Impatients, , to review
Impatients’ Records with respect to the Services, except for Records that may
not be shared due to Applicable Laws, including but not limited to data privacy
laws.         3.4. Personnel. Subject to the provisions of Section 3.2 of this
Agreement, Impatients will engage, and will require its Subcontractors to
engage, an appropriate number of employees with the proper education, training
and experience (“Impatients Personnel”) to enable the performance of the
Services in compliance with the Applicable Laws and this Agreement. Impatients
shall ensure that all Impatients Personnel are required to comply with the
obligations imposed by this Agreement and with the Applicable Laws.

 

4. Regulatory, Quality and Pharmacovigilance.

 

  4.1. Regulatory.

 

  (i) Scope. Mateon will be the approve for all content of any communications
with Regulatory Authorities and physicians with respect to matters relating to
Services, unless specified otherwise (for example when the treating physician
obtains expanded access approval directly from the competent authority). With
Mateon’s prior approval, Impatients will interact with Regulatory Authorities
and/or Ethics Committees / Institutional Review Boards (IRBs) as required by
local regulation on Mateon`s behalf. With Mateon’s prior approval, Impatients
will also support treating physicians to interact directly with competent
authorities. The purpose of this section is to describe how Mateon will maintain
control of the content of interactions with Regulatory Authorities and treating
physicians and at the same time enable Impatients to manage or execute certain
of those interactions on Mateon`s behalf.         (ii) Impatients will on
Mateon’s behalf work with physicians and treatment centers to file applications
within the Field for Expanded Access Approvals and shall on Mateon’s behalf
communicate with the Regulatory Authorities, to secure Expanded Access Approvals
for the Product in the Territory.         (iii) Impatients will notify Mateon by
telephone and email immediately but no later than one (1) Business Day after
Impatients receives any communication from any Regulatory Authority relating to
the Services and will provide Mateon with copies of such communication. Unless
prohibited by the Applicable Laws, Impatients will consult in advance with
Mateon regarding the response to any inquiry or observation from any Regulatory
Authority relating to the Services and will comply with all requests and
comments by Mateon with respect to all communications with any Regulatory
Authority relating to the Services.

 

 

 

 

  (iv)  For the avoidance of doubt, Impatients will only use materials and/or
information for all communications relating to the Services, including, but not
limited, to competent authorities, Regulatory Authorities, or physicians,
regardless of whether such materials and information will be communicated in
writing or verbally, that have been reviewed and approved by Mateon per Mateon’s
internal procedures and policies. Impatients will not make any changes or
alteration to these materials and/or information unless approved by Mateon.    
    (v) If Impatients receives written or electronic correspondence from any
Regulatory Authority relating to the withdrawal, suspension, or revocation of a
regulatory approval or Expanded Access Approval for Product in the Field, the
prohibition or suspension of the supply of a Product in the Field, or the
initiation of any investigation, review, or inquiry by such Regulatory Authority
concerning the safety and quality of a Product in the Field, Impatients shall
notify Mateon and provide copies of such written or electronic correspondence
within one (1) Business Day.

 

  4.2. Quality. Mateon shall be responsible for manufacturing and distribution,
including, but not limited to, labeling and packaging, testing and QP release,
compliant to GMP and GDP regulations and other Applicable Laws. If quality or
distribution complaints related to the Product are received by Impatients or
Impatients is notified of a temperature excursion related to the Product that
occurred during transport to the customer, Impatients shall notify Mateon on the
information received without undue delay. In case of a recall related to the
Product, Mateon shall be responsible for the execution of the recall and the
communication with the competent authorities. If requested by Mateon, Impatients
may provide reasonable support for the handling of complaints or the
communication of the recall. Any costs incurred by Impatients for support shall
be borne by Mateon.         4.3. Pharmacovigilance. Mateon shall be responsible
for the performance of pharmacovigilance obligations with respect to the
Product. If potential safety information related to the Expanded Access Program
is received by Impatients, Impatients shall instruct the providing HCP to
promptly report to Mateon using the SAE report form and notify Mateon on the
information received within one (1) Business Day. An ICSR report will be
processed in the format required for authority reporting by Mateon (or its
specialized third-party service provider).         4.4. Information. Mateon, at
its discretion, will provide Impatients with all relevant information required
to provide the Services.

 

5. Mutual Representations and Warranties. The parties represent and warrant to
each other, as of the Effective Date, as follows:

 

  5.1. Organization of Parties. Each party is and will remain a corporation or
company duly organized, validly existing and in good standing under the laws of
its jurisdiction of organization, and has the requisite power and authority,
corporate or otherwise, to execute, deliver, and perform this Agreement.

 

 

 

 

  5.2. Enforceability of this Agreement. The execution and delivery of this
Agreement by both parties has been authorized by all requisite corporate or
company action. This Agreement is and will remain a valid and binding obligation
of both parties, enforceable in accordance with its terms, subject to laws of
general application relating to bankruptcy, insolvency and the relief of
debtors.         5.3. Absence of Other Contractual Restrictions. Parties are
under no contractual or other obligation or restriction that is inconsistent
with the terms of this Agreement or any Statement of Work, or that would impede
the diligent and complete fulfilment of the parties’ obligations hereunder.
Parties will not enter into any agreement, either written or oral, that would
conflict with parties’ responsibilities under this Agreement or any Statement of
Work.         5.4. Compliance. Each party shall comply and shall cause its and
its Affiliates’ employees and contractors to comply with all Applicable Laws,
the terms of this Agreement and the Statements of Work in the performance of its
obligations under this Agreement and shall perform its obligations under this
Agreement with requisite care, skill and diligence.         5.5. Conflicts with
Rights of Third Parties. The conduct and provision of Services will not violate
any patent, trade secret or other proprietary or intellectual property right of
any third party.         5.6. Absence of Debarment. Impatients, its Affiliates,
Impatients Personnel, Subcontractors and each of their respective officers and
directors, as applicable: (a) have not been debarred or disqualified by any
governmental authority or regulatory agency, and are not subject to a pending
debarment or disqualification, and will not use in any capacity in connection
with Services any person who has been debarred or disqualified or is subject to
a pending debarment or disqualification by any governmental or regulatory
agency; and (b) have not been convicted of a criminal offense related to the
provision of healthcare items or services and are not subject to any such
pending action. Impatients will notify Mateon immediately if Impatients, its
Affiliates, any Impatients Personnel, any Subcontractor or any of their
respective officers or directors, as applicable, is subject to the foregoing, or
if any action, suit, claim, investigation, or proceeding relating to the
foregoing is pending, or to the best of Impatients’ knowledge, is threatened.

 

6. Compensation.

 

  6.1. Fees. As full consideration for Services, Mateon will pay Impatients the
amounts set forth in the applicable Statement of Work in accordance with the
payment schedule set forth in such Statement of Work. Impatients will invoice
Mateon for all amounts due in USD. All payments will be made by Mateon within
thirty (30) days after its receipt of an invoice.         6.2. Expenses.
Reasonably incurred expenses shall be reimbursed by Mateon.

 

 

 

 

  6.3. Fair Market Value. Impatients shall comply with all Applicable Laws and
industry standards, which govern the marketing and advertising of pharmaceutical
products, and Interactions with Healthcare Professionals. Impatients shall
include information relating to any payments to a health care professional
(“HCP”) or other transfers of value, including any payments through its
subcontractors (collectively “HCP Payments”), in its invoices provided to
Mateon. If and when applicable, Impatients shall report and demonstrate that all
HCP Payments reflect the fair market value of the services provided by the HCPs
in its invoices. Impatients will maintain financial records of any HCP Payments
in accordance with the requirements of Section 7, including copies of invoices
relating to any such HCP Payments. Impatients shall not make any payment or
other transfer of value on Mateon’s behalf (including any HCP Payments) that
exceed fair market value. Impatients agrees that the compensation being paid
under this Agreement and under any Statement of Work constitutes the fair market
value of the Services to be provided hereunder. No amounts paid under this
Agreement are intended to be for, nor shall they be construed as, an offer or
payment made in exchange for any explicit or implicit agreement for, past,
present or future purchasing, recommending, leasing or other use of any Mateon
or any Mateon Affiliate’s product or service.

 

7. Proprietary Rights.

 

  7.1. Materials. All documentation, information, and biological, chemical or
other materials controlled by Mateon and furnished to Impatients by or on behalf
of Mateon (collectively, with all associated intellectual property rights, the
“Materials”) will remain the exclusive property of Mateon. Impatients will use
Materials only as necessary to perform Services.         7.2. Deliverables.

 

  (i) Ownership. Mateon will own all rights throughout the world to all
inventions, discoveries, improvements, ideas, processes, formulations, products,
computer programs, works of authorship, databases, trade secrets, know-how,
information, data, documentation, reports, applications, permissions,
exemptions, approvals, authorizations and/or waivers, research, creations and
all other products and/or materials related to the Product (whether or not
patentable or subject to copyright or trade secret protection) (collectively,
with all associated intellectual property rights, the “Deliverables”).
Impatients will assign and does assign to Mateon all right, title and interest
in and to all Deliverables and will promptly disclose to Mateon all
Deliverables. For purposes of the copyright laws of the Applicable Laws,
Deliverables constitute “works made for hire,” except to the extent such
Deliverables cannot by law be “works made for hire”.         (ii) Impatients
Property. Notwithstanding the foregoing, Impatients will retain full ownership
rights in and to all templates, programs, methodologies, processes,
technologies, know-how and all other materials developed or licensed by
Impatients and its Affiliates prior to or apart from performing its obligations
under this Agreement (collectively, with all associated intellectual property
rights, the “Impatients Property”), regardless of whether such Impatients
Property is used in connection with Impatients’ performance of its obligations
under this Agreement.

 

  7.3. Work at Third Party Facilities. Impatients agrees not to accept or use
any funds, space, personnel, facilities, equipment or other resources of a third
party in performing Services or take any other action that could result in a
third party owning or having a right in any Deliverables.

 

 

 

 

  7.4. Records; Storage. Impatients will maintain all materials, data and
documentation obtained or generated by Impatients solely related to the Product
and in the course of preparing for and providing Services, including
computerized records and files (collectively, the “Records”) as required by the
Applicable Laws and in a secure area reasonably protected from fire, theft and
destruction. All Records, other than financial records of Impatients, will be
the property of Mateon. Impatients will not transfer, deliver or otherwise
provide any Records to any party other than Mateon or its Affiliates, without
the prior approval of Mateon, unless Impatients is obligated to do so under any
Applicable Laws or by court order.         7.5. Record Retention. All Records
will be retained by Impatients for a minimum period of five (5) years following
completion of the applicable Statement of Work, or longer if required by the
Applicable Laws. Impatients will, at the direction and written request of
Mateon, promptly deliver Records to Mateon or its designee, or dispose of the
Records, unless the Records are required to be retained by Impatients by
Applicable Laws. In no event will Impatients dispose of any Records without
first giving Mateon thirty (30) days’ prior written notice of its intent to do
so.

 

8. Confidentiality and Data Protection.

 

  8.1. Definition. “Confidential Information” means any and all non-public
scientific, technical, financial regulatory or business information, or data in
whatever form (written, oral or visual) that is furnished or made available by
or on behalf of one party (the “Discloser”) to the other (the “Recipient”) or
developed by Impatients in connection with Services. Confidential Information
includes (x) Materials, Deliverables, Records, scientific data and medical data
insofar as this is permitted by Applicable Laws, investigator brochures,
protocols and correspondence with or from institutional review boards and other
entities with oversight responsibilities for clinical studies that are the
subject of Services, including ethics committees and data safety monitoring
committees; (y) development and marketing plans, regulatory and business
strategies, financial information, and forecasts; and (z) all information of
third parties that a party has an obligation to keep confidential, whether or
not, in each case, such materials or information are marked or identified as
confidential.         8.2. Obligations. During the term of this Agreement and
for a period of ten (10) years thereafter, Recipient agrees to (a) hold in
confidence all Discloser’s Confidential Information, and not disclose
Discloser’s Confidential Information except as expressly provided in Section
8.3, without the prior written consent of Discloser; (b) use Discloser’s
Confidential Information solely to carry out Recipient’s rights or obligations
under this Agreement; (c) treat Discloser’s Confidential Information with the
same degree of care Recipient uses to protect Recipient’s own confidential
information but in no event with less than a reasonable degree of care; and (d)
reproduce Discloser’s Confidential Information solely to the extent necessary to
carry out Recipient’s rights or obligations under this Agreement, with all such
reproductions being considered Discloser’s Confidential Information.        
8.3. Permitted Disclosures. Recipient may provide Discloser’s Confidential
Information to its and its affiliates’ directors, employees, consultants,
contractors and agents on a need to know basis and solely as necessary to carry
out Recipient’s rights or obligations under this Agreement; provided, that
Recipient remains liable for the compliance of such affiliates, directors,
employees, consultants, contractors and agents with the terms of this Agreement.
Recipient may also disclose Discloser’s Confidential Information to third
parties only to the extent such disclosure is required (i) to comply with the
Applicable Laws; or (ii) by a governmental authority or by order of a court of
competent jurisdiction; provided, that Recipient provides prior written notice
of such disclosure to Discloser, takes all reasonable and lawful actions to
avoid or minimize the degree of such disclosure, and cooperates reasonably with
Discloser in any efforts to seek a protective order.

 

 

 

 

  8.4. Exceptions. Recipient’s obligations of non-disclosure and non-use under
this Agreement will not apply to any portion of Discloser’s Confidential
Information that Recipient can demonstrate, by competent proof:

 

  (i) is generally known to the public at the time of disclosure or becomes
generally known through no wrongful act on the part of Recipient;         (ii)
is in Recipient’s possession at the time of disclosure other than as a result of
Recipient’s breach of any legal obligation;         (iii) becomes known to
Recipient on a non-confidential basis through disclosure by sources other than
Discloser having the legal right to disclose such Confidential Information; or  
      (iv) is independently developed by Recipient without reference to or
reliance upon Discloser’s Confidential Information.

 

  8.5. Data Protection.

 

  (a) Each party may collect, use and store personal data, as this term is
defined in the Applicable Laws, relating to its directors, officers, employees,
contractors and agents for the purposes of performance of Services in this
Agreement. Each party may also provide to the other party such personal data for
these purposes. Each party shall ensure its compliance with all Applicable Laws
with respect to such personal data. Each party agrees to obtain the necessary
consents from its directors, officers, employees, contractors, and agents to the
disclosure, collection, use, storage of their personal data to the other party
and to the transfer of such personal data outside of the EU where the laws of
which may not provide the same level of data protection as do the laws of the
EU. Each party shall ensure that its directors, officers, employees, contractors
and agents are aware that their personal data will be collected, used and stored
for the above-mentioned purposes, that those data may be made available to the
other party and transferred outside the EU and that they consent to such
collection, use, storage and potential transfer. Additionally, each party agrees
to secure all Confidential Information in their control using appropriate
security controls that are in alignment with legally mandated controls.        
(b) Mateon shall be the “controller” for any personal data relating to the
Services and Impatients shall be the “processor” of this personal data as these
terms are defined in Article 4 of the General Data Protection Regulation EU
2016/279 (“GDPR”). Impatients shall process such personal data on behalf of
Mateon solely for the purposes of performance of this Agreement and the
Services, in accordance with the Applicable Laws and the Data Processing
Agreement, which is entered into separately by the Parties.

 

 

 

 

9. Indemnification, Insurance and Remedies.

 

  9.1. Indemnification by Impatients. Impatients will indemnify, defend and hold
harmless Mateon, its Affiliates, and its and their respective officers,
directors, employees and agents (collectively, the “Mateon Indemnitees”) against
any third party claims, including reasonable attorneys’ fees for defending those
claims, to the extent such claims arise out of or relate to (a) the performance
of Services by any Impatients Indemnitee (as defined in Section 7.2) or any
injury or harm to Impatients’ Personnel alleged by such Impatients’ Personnel to
have occurred on Mateon’s or its Affiliates’ premises during the course of
performance of Services (except to the extent such claims result from Mateon’s
breach of this Agreement, breach of the Applicable Laws or a Mateon Indemnitee’s
negligence or willful misconduct); (b) any Impatients Indemnitee’s negligence or
willful misconduct in performing obligations under this Agreement; or (c)
Impatients’ breach of this Agreement or the Applicable Laws.         9.2.
Indemnification by Mateon. Mateon will indemnify, defend and hold harmless
Impatients, its Affiliates, and its and their respective officers, directors,
employees and agents (collectively, the “Impatients Indemnitees”) against any
third party claims, including reasonable attorneys’ fees for defending those
claims, to the extent such claims arise out of or relate to (a) the use of the
Deliverables by Mateon or its Affiliates (except to the extent such claims
result from Impatients’ breach of this Agreement, breach of the Applicable Laws
or an Impatient Indemnitee’s negligence or willful misconduct); (b) any Mateon
Indemnitee’s negligence or willful misconduct in performing obligations under
this Agreement; or (c) Mateon’s breach of this Agreement or the Applicable Laws.
Mateon shall further indemnify, defend and hold harmless the Impatients
Indemnitees for any third-party claims, suits, demands, judgments, actions,
liabilities, (including strict liability and infringement of a third party’s
patent rights) expenses (including reasonable attorney’s fees) and damages
solely relating to the Product.         9.3. Indemnification Procedures. Each
party must notify the other party within thirty (30) days after receipt of any
claims made for which the other party might be liable under Section 9.1 or 9.2,
as applicable. The indemnifying party will have the sole right to defend,
negotiate, and settle such claims. The indemnified party will be entitled to
participate in the defense of such matter and to employ counsel at its expense
to assist in such defense; provided, however, that the indemnifying party will
have final decision-making authority regarding all aspects of the defense of the
claim. The indemnified party will provide the indemnifying party with such
information and assistance as the indemnifying party may reasonably request, at
the expense of the indemnifying party. Neither party will be responsible or
bound by any settlement of any claim or suit made without its prior written
consent; provided, however, that the indemnified party will not unreasonably
withhold or delay such consent.         9.4. Waiver of Consequential or Punitive
Damages/Limitation of Liability. Save as for gross negligence or intentional
wrongdoing by a party, neither party, nor any of their respective directors,
officers, employees or agents shall have any liability towards the other party,
for any indirect or consequential damages claimed by the other party, including
but not limited to the loss of opportunity, loss of use, and/or loss of revenue
or profit, in connection with or arising out of this Agreement, any Statement of
Work or breach thereof.

 

 

 

 

  9.5. Insurance. During the term of this Agreement and for a period of at least
two (2) years after termination or expiration of this Agreement, each party will
maintain any and all insurance coverage required by the Applicable Laws and
sufficient to cover the other party’s liability that may arise under this
Agreement or any Statement of Work. Each party shall on request provide the
other party with a Certificate of Insurance evidencing such insurance coverage.
        9.6. Remedies. Each party agrees that (i) the other party may be
irreparably injured by a breach of this Agreement; (ii) money damages would not
be an adequate remedy for any such breach; and (iii) the other party will be
entitled to seek equitable relief, including injunctive relief and specific
performance, without having to post a bond, as a remedy for any such breach. The
provisions of this Section 9.6 are not exclusive, and each party may seek any
other right or remedy that it may have under this Agreement or otherwise.

 

10. Term and Termination.

 

  10.1. Term. This Agreement will become legally effective on the Effective Date
and, unless earlier terminated pursuant to the terms hereof, shall continue in
full force and effect for an initial period of three (3) (“Initial Term”). This
Agreement will automatically extend by subsequent periods of one (1) year each
following the end of a term (“Subsequent Term”; Initial Term and Subsequent Term
each referred to as a “Term”).         10.2. Early Termination. Mateon may
terminate this Agreement or a Statement of Work at any time upon forty-five (45)
days’ prior written notice to Impatients. Impatients may terminate this
Agreement or a Statement of Work at any time after the first six months
following the Effective Date and upon thirty (30) days’ prior written notice to
Mateon.         10.3. Termination for Breach. Either party may terminate this
Agreement or any Statement of Work for material breach of this Agreement or
breach of the Applicable Laws if the breaching party fails to cure such breach
no later than sixty (60) days after receiving written notice. In the event a
party breaches a material obligation under this Agreement or any Statement of
Work that cannot be cured (e.g. breach of confidentiality obligations), this
Agreement or any Statement of Work may be terminated with immediate effect upon
written notice to the breaching party.         10.4. Effect of Termination. Upon
termination of this Agreement or any Statement of Work, as applicable, neither
Impatients nor Mateon will have any further obligations, except for the
following:

 

  (i) Impatients will terminate services in progress in accordance with a
schedule agreed to by Mateon, unless Mateon specifies in the notice of
termination that services in progress should be completed;         (ii)
Impatients will deliver to Mateon all Deliverables, whether completed or not;  
      (iii) As directed by Mateon, Impatients will either return to Mateon any
Materials and Mateon Records in its possession or control or arrange for their
secure destruction;

 

 

 

 

  (iv) Mateon will pay Impatients for all work performed under an applicable
Statement of Work until the moment of termination, pay all outstanding and
correct invoices and reimburse incurred expenses as authorized in the applicable
Statement of Work;         (v) Recipient will promptly return to Discloser all
of Discloser’s Confidential Information (including all copies) except for one
(1) copy which Recipient may retain solely for compliance purposes, subject to
confidentiality obligations that survive termination; and         (vi) Sections
3.1, 3.3, 4, 6, 7, 8, 9, and 10 survive termination or expiration.

 

11. Miscellaneous.

 

  11.1. Independent Contractor. Impatients is an independent contractor and not
an agent or employee of Mateon. Impatients will not in any way represent itself
to be an agent, employee, partner or joint ventures of or with Mateon, and
Impatients has no authority to obligate or bind Mateon by contract or otherwise.
Impatients is responsible for, and will withhold and/or pay, all contributions
required by the Applicable Laws. No Impatients employees or other Impatients
Personnel will be entitled to any benefits applicable to or available to
employees of Mateon. Impatients understands and agrees that it is solely
responsible for such matters and that it will indemnify Mateon and hold Mateon
harmless from all claims and demands in connection with such matters.        
11.2. Publicity. Except to the extent required by the Applicable Laws,
Impatients will not make any public statement or release concerning this
Agreement or the transactions contemplated by this Agreement or use Mateon’s
name or the name of any Affiliate of Mateon in any form of advertising,
promotion, or publicity without obtaining the prior written consent of Mateon.  
      11.3. Notices. All notices must be in writing and sent to the addresses
specified below, or at such other address as a party may specify in writing
under this procedure. Notices shall be given (a) by personal delivery, with
receipt acknowledged; (b) by prepaid certified or registered mail, return
receipt requested; or (c) by prepaid recognized express delivery service.
Notices will be effective upon receipt or at a later date stated in the notice.
Party addresses for notices are:

 

  To Mateon:

Mateon therapeutics INC.

23397 Agoura Rd., Suite 107

Agoura Hills, CA 91301

United States of America

Attn: XX

  With a copy to: XXX         To Impatients:

Impatients N.V.

Anthony Fokkerweg 61

1059 CP Amsterdam

The Netherlands

Attn: Corporate Development, D. Akkaya

  With a copy to:

Impatients N.V.

Anthony Fokkerweg 61

1059 CP Amsterdam

The Netherlands

Attn: General Counsel, P.E. de Ridders

 

 

 

 

  11.4. Assignment. Neither this Agreement nor any rights or obligations
hereunder may be assigned, or duties delegated (other than explicitly specified)
by either party without the prior written consent of the other party, which
consent shall not be unreasonably withheld. Notwithstanding the foregoing, each
party may assign this Agreement, without the written consent of the other party
to: (a) an Affiliate; and/or (b) an entity that acquires all or substantially
all of the stock, business or assets of such party to which this Agreement
pertains (whether by merger, reorganization, acquisition, sale or otherwise).
Any assignment in violation of this clause shall be null and void. Any permitted
assignee shall, upon the request of the other party hereto, expressly
acknowledge, by written agreement, its assumption of all obligations and
liabilities under this Agreement. No assignment, delegation or transfer will
relieve either party of the performance of any accrued obligation that such
party may then have under this Agreement.         11.5. Entire Agreement. This
Agreement, together with the attached Appendices and any fully-signed Statements
of Work, each of which are incorporated into this Agreement, constitute the
entire agreement between the parties with respect to the specific subject matter
of this Agreement and all prior agreements, oral or written, with respect to
such subject matter are superseded.         11.6. Remedy; Waiver. Exercise by
any party of any of its rights under this Agreement shall not be deemed to limit
any other right or remedy that such party may have in law or equity. The waiver
by either party of a breach of any of the provisions of this Agreement by the
other party shall not be construed as a waiver of any succeeding breach of the
same or other provisions; nor shall any delay or omission by either party in
exercising any right that it may have under this Agreement operate as a waiver
of any breach or default by the other party.         11.7. No Modification. This
Agreement (including, but not limited to, any Statement(s) of Work) may be
changed only by a writing signed by authorized representatives of each party.  
      11.8. Severability; Reformation. Each provision in this Agreement is
independent and severable from the others, and no provision will be rendered
unenforceable because any other provision is found by a proper authority to be
invalid or unenforceable in whole or in part. If any provision of this Agreement
is found by such an authority to be invalid or unenforceable in whole or in
part, such provision will be changed and interpreted so as to best accomplish
the objectives of such unenforceable or invalid provision and the intent of the
parties, within the limits of the Applicable Laws.         11.9. Event of
Conflict. All terms and conditions of this Agreement will apply to any Statement
of Work. In the event of any conflict between the terms and conditions of this
Agreement and any Statement of Work, the terms and conditions of this Agreement
will take precedence over any Statement of Work; provided, however, that the
parties may agree that a specific term of this Agreement shall not apply or
shall be modified or amended with respect to a particular Statement of Work (and
only with respect to that Statement of Work) by signing a Statement of Work
where the parties intend to waive such specific term, for the limited purpose of
that particular Statement of Work. No other terms, including, without
limitation, any terms or conditions set forth in any document issued by either
party, are effective unless accepted by the other party in writing.

 

 

 

 

  11.10. Governing Law. This Agreement and any disputes arising out of or
relating to this Agreement will be governed by, construed and interpreted in
accordance with the laws of the Netherlands, without regard to any choice of law
principle that would require the application of the law of another jurisdiction.
All parties consent to the exclusive jurisdiction of the courts of Amsterdam in
the Netherlands and waive any objection to the propriety or convenience of such
venues. The parties expressly reject any application to this Agreement of (a)
the United Nations Convention on Contracts for the International Sale of Goods;
and (b) the 1974 Convention on the Limitation Period in the International Sale
of Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980.
        11.11. Counterparts. This Agreement may be executed in any number of
counterparts, each of which will be deemed to be an original and all of which
together will constitute one and the same instrument

 

IN WITNESS WHEREOF, each party has caused this Agreement to be executed by its
duly authorized representative as of the Effective Date.

 

MATEON THERAPEUTICS, INC.   IMPATIENTS N.V. By: /s/ Vuong Trieu   By: /s/ Pieter
Erik de Ridders Name: Vuong Ttrieu   Name: Pieter Erik de Ridders Title: CEO  
Title: General Counsel