Exhibit 10.5

Confidential Treatment Requested by Achaogen, Inc.

 

COLLABORATIVE DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

This Collaborative Development and Commercialization Agreement (“Agreement”) is
entered into as of April 26, 2016 (“Effective Date”) by and between Microgenics
Corporation (hereinafter “Microgenics”), having its principal place of business
at 46500 Kato Road, Fremont, California 94538, and Achaogen Inc. (hereinafter
“Achaogen”), having a place of business at 7000 Shoreline Court, #371, South San
Francisco, California 94080. Both Microgenics and Achaogen are referred to
herein individually as a “Party” and collectively as the “Parties.”  

 

WHEREAS, Achaogen possesses certain intellectual property rights and know-how
relating to drug compound Plazomicin;

 

WHEREAS, Microgenics has certain expertise and know-how relating to the
development, manufacture and sale of immunoassays for in vitro diagnostic use;

 

WHEREAS, the Parties are undertaking, as of the Effective Date, activities under
that certain Antibody Development Agreement, dated [***] (the “Antibody
Development Agreement”), for the purpose of identifying and developing
antibodies against Plazomicin and this Agreement is the “Assay Commercialization
Agreement” referred to in Section 2.6 of the Antibody Development Agreement; and

 

WHEREAS, the Parties desire to collaborate on the development and
commercialization of a therapeutic drug monitoring assay for the measurement of
concentrations of Plazomicin in biological fluids.

 

NOW THEREFORE, in consideration of the foregoing premises and the covenants and
promises contained herein, the Parties intending to be bound, hereby agree as
follows:

 

1.Definitions

 

For the purposes of this Agreement and the Exhibits hereto, the following words
and phrases shall have the following meanings (words defined in the Agreement
shall have the meaning ascribed to them in that Section):

 

1.1“Achaogen Know-How” shall mean all proprietary, technical and clinical
information, data and know-how relating to Plazomicin and haptens and polyclonal
antibodies related directly to Plazomicin, whether or not patentable, which is
Controlled as of the Effective Date or acquired during the Term by Achaogen.

 

1.2“Achaogen Materials” shall mean the materials set forth in Exhibit A.  

 

1.3“Achaogen Patents” shall mean the Patents and Patent applications set forth
in Exhibit B hereto.

 

1.4“Affiliate” shall mean, with respect to a Party, any corporation, or other
business entity which directly controls, is controlled by or is under common
control with that Party. A person or entity shall be regarded as in control of
another entity if it owns, directly or indirectly, fifty percent (50%) or more
of the outstanding equity securities of the subject entity which is entitled to
vote in the election of directors, or a fifty percent (50%) or greater interest
in the net assets or profits of the subject entity if such entity is not a
corporation.

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1.5“Applicable Law” shall mean all applicable provisions of all statutes, laws,
rules, regulations, administrative codes, ordinances, decrees, orders,
decisions, injunctions, awards judgments, permits and licenses of or from
governmental authorities, including those relating to or governing the use or
regulation of the subject item and the listing standards or agreements of any
national or international securities exchange.

 

1.6“Assay” shall mean an antibody-based immunoassay or immunoassays used for the
in vitro measurement of Plazomicin concentration in human blood and other body
fluids, [***], that (a) uses or otherwise would infringe Immunoassay
Technologies, (b) is developed by Microgenics and its Affiliates under this
Agreement, and (c) [***].

 

1.7“Commercially Reasonable Efforts” shall mean efforts and resources normally
utilized by a Party for a product owned by it or to which it has rights, which
is of similar market potential at a similar stage in its product life, taking
into account the competitiveness of the marketplace, the proprietary position of
the product, the regulatory structure involved, the profitability of the
applicable products, the relative benefit that accrues to actual and potential
patients and other relevant factors; provided, that, in any event, “Commercially
Reasonable Efforts” under this Agreement require that a Party (a) [***],
(b) [***], and (c) [***].

 

1.8“Confidential Information” shall mean all proprietary and confidential
business, technical, scientific, and/or regulatory information relating to the
Assay, Plazomicin, and/or the purpose of, or activities under, this Agreement,
that is provided by or on behalf of a Disclosing Party to a Receiving Party
hereunder, whether disclosed in writing or orally.

 

1.9“Control” shall mean with respect to any (a) item of information, including
know-how, or (b) intellectual property right, the possession (whether by
ownership or license) by a Party of the ability to grant to the other Party
access and/or a license as provided herein under such item or right without
violating the terms of any agreement or other arrangements with any Third Party
existing before or after the Effective Date.

 

1.10“Development and Manufacturing Phase” shall mean that phase of the Research
Program set forth in the Project Plan relating to the optimization of the Assay
and the manufacture and validation of [***] ([***]) production lots of the Assay
that meet the Specifications [***].

 

1.11“Feasibility Study Phase” shall mean that phase of the Research Program set
forth in the Project Plan comprising all studies conducted by Microgenics to
establish the feasibility for developing the Assay by demonstrating (a) [***],
(b) [***], (c) [***], (d) [***], (e) [***], and (f) [***].

 

1.12“First Commercial Sale” shall mean (a) with respect to the Assay, the
initial sale by or on behalf of Microgenics (or its Affiliates) of the Assay and
(b) with respect to Plazomicin, the initial sale by or on behalf of Achaogen (or
its Affiliates) of Plazomicin, in each case, to a Third Party in exchange for
cash or some equivalent to which value can be assigned; provided, that a sale of
the Assay or Plazomicin, as applicable, in connection with [***] of the Assay or
Plazomicin, as applicable, or for [***] therefor will not constitute First
Commercial Sale.

 

1.13“Good Clinical Practice” or “GCP” shall mean the then current standard for
clinical trials for assays, as set forth in the United States Federal Food, Drug
and Cosmetics Act and applicable regulations

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promulgated thereunder, as amended from time to time and such standards of good
clinical practice as are required by the European Union and other organizations
and governmental agencies in countries where the Assay is intended to be sold,
to extent such standards are no less stringent than United States GCP.

 

1.14“Good Laboratory Practice” or “GLP” shall mean the then current standards
for laboratory activities for assays, as set forth in the United States Federal
Food, Drug and Cosmetics Act and applicable regulations promulgated thereunder,
as amended from time to time and such standards of good laboratory practice as
are required by the European Union and other organizations and governmental
agencies in countries where the Assay is intended to be sold, to extent such
standards are no less stringent than United States GLP.

 

1.15“Good Manufacturing Practices” or “GMP” shall mean the then current
standards for the manufacture of assays, as set forth in the United States
Federal Food Drug and Cosmetics Act and applicable regulations promulgated
thereunder, as may be amended from time to time and such standards of good
manufacturing practice as are required by the European Union and other
organizations and governmental agencies in countries where the Assay is intended
to be sold, to extent such standards are no less stringent than United States
GMP.

 

1.16“Immunoassay Technologies” shall mean technologies, including any patentable
or unpatentable intellectual property rights appurtenant thereto, Controlled by
Microgenics or its Affiliates suitable for developing and manufacturing assays,
calibrators and controls for application on [***], including [***] assay
technology, [***] technology, [***] technology, [***] immunoassay, the
Microgenics Cell Line, and Microgenics [***] Antibodies.

 

1.17“Microgenics Cell Line” shall mean those certain cell lines (a) that were
developed under the Antibody Development Agreement, or (b) that produce
Microgenics [***] Antibodies and are Controlled by Microgenics and listed in
Exhibit C, as such Exhibit may be amended from time to time upon the mutual
written agreement of the Parties.

 

1.18“Microgenics Know-How” shall mean all proprietary, technical information,
data and know-how relating to the Assay or Immunoassay Technologies and reagents
for use therewith which are Controlled as of the Effective Date or acquired or
developed during the Term by Microgenics or its Affiliates.

 

1.19“Microgenics [***] Antibodies” shall mean [***] antibodies developed by, or
Controlled by, Microgenics or its Affiliates and directed to Plazomicin.  

 

1.20“Patent” shall mean any existing or future: (a) national, regional or
international patent or patent application in any jurisdiction (including any
provisional, divisional, continuation, continuation-in-part, non-provisional,
converted provisional, or continued prosecution application, any utility model,
petty patent, design patent and/or certificate of invention), (b) any extension,
restoration, revalidation, reissue, re-examination and extension (including any
supplementary protection certificate and the like) of any of the foregoing
patents or patent applications, and (c) any ex-U.S. equivalents corresponding to
any of the foregoing.

 

1.21“Plazomicin” shall mean Achaogen’s aminoglycoside antibiotic that is in
Phase 3 clinical development as of the Effective Date and having the chemical
structure shown on Exhibit D, and [***] thereof, regardless of commercial name.

 

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1.22“Primary Countries” shall mean (a) the countries set forth on Exhibit E and
(b) any other country in the Territory which the Parties mutually agree in
writing shall be a Primary Country in accordance with Section 4.2.5, in each
case, for which the Parties intend to pursue initial registration,
commercialization and launch of the Assay.

 

1.23“Project Plan” shall mean the plan of work to be conducted under the
Research Program pursuant to Section 2.1 (Project Plan) hereof as attached as
Exhibit F.

 

1.24“Regulatory Approval” shall mean all authorizations, registrations or
clearances with or by the appropriate Regulatory Authorities which are required
for the marketing, promotion, pricing and sale of either the Assay or
Plazomicin, as applicable, in any country or regulatory jurisdiction in the
Territory.

 

1.25“Regulatory Authority” shall mean any national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity involved in the granting of Regulatory Approval,
including the United States Food and Drug Administration.

 

1.26“Research Program” shall mean the collaborative program of research relating
to the development of the Assay to be carried out by the Parties pursuant to
this Agreement.  

 

1.27“Secondary Countries” shall mean all countries in the Territory, other than
the Primary Countries.

 

1.28“Shortfall License” shall mean a temporary, fully-paid up, royalty-free,
worldwide non-exclusive license granted by Microgenics (including on behalf of
its Affiliates as appropriate), under Section 4.3.2.3, to (a) the Immunoassay
Technologies and (b) all other intellectual property rights (including Patent
applications, Patents, trade secrets, copyrights, and trademarks) (i) of
Microgenics (or its Affiliates as appropriate) arising out of the performance of
this Agreement or the Antibody Development Agreement, or (ii) Controlled by
Microgenics (or its Affiliates as appropriate) that are necessary or desirable
for or used in the manufacture and commercialization of the Assay, which license
would be for the manufacture, use, sale, offer for sale and import of the Assay.
Such license shall be fully sub-licensable to any Third Party for purposes of
manufacturing and commercializing the Assay (including the components thereof)
under Section 4.3.2.3.

 

1.29“Specifications” shall mean the specifications applicable to the Assay, as
set forth on Exhibit G.  

 

1.30“Territory” shall mean the world.

 

1.31“Third Party(ies)” shall mean any person(s) or entity(ies) other than
Achaogen, Microgenics or their respective Affiliates.

 

1.32“Trademarks” shall mean all registered and unregistered trademarks
(including all common law rights thereto), service marks, trade names, brand
names, logos, taglines, slogans, certification marks, Internet domain names,
trade dress, corporate names, business names and other indicia of origin,
together with the goodwill associated with any of the foregoing and all
applications, registrations, extensions and renewals thereof throughout the
world, and all rights therein provided by international treaties and
conventions.

 

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1.33“Transfer License” shall mean a royalty-bearing, worldwide exclusive license
granted by Microgenics (including on behalf of its Affiliates as appropriate),
under Section 9.4.4.1, to (a) the Immunoassay Technologies and (b) all Patent
applications, Patents, trade secrets and other know-how, (i) of Microgenics (or
its Affiliates as appropriate) arising out of the performance of this Agreement
or the Antibody Development Agreement, or (ii) Controlled by Microgenics (or its
Affiliates as appropriate) as of the termination date of this Agreement that are
necessary for or used in the development, manufacture, and commercialization of
the Assay, which license would be solely for the development, manufacture, use,
sale, offer for sale and import of the Assay in connection solely with the use
of Plazomicin. Such license shall be fully sub-licensable to any Third Party for
purposes of manufacturing and commercializing the Assay (including the
components thereof) [***].

 

1.34Additional Definitions.  Each of the following definitions is set forth in
the Section of the Agreement indicated below.  

 

Definition

Section

AAA

13.8.2

Abandoned Commercialization

4.2.7.1

Abandoned Development

4.2.7.1

Achaogen

Preamble

Achaogen Indemnified Parties

11.2

Achaogen Inventions

8.1

Agreement

Preamble

Alliance Manager

5.1.1

Antibody Development Agreement

Recitals

Assay Commercialization Plan

4.2.4

Audit Outcome

4.4.2

Back-up Supplier

4.3.2.2

Binding Forecast

4.2.2

Commercial Leader

5.3.1

Convicted Entity or Convicted Individual

10.4.4

Debarred Entity

10.4.2

Debarred Individual

10.4.1

Development Leader

5.3.1

Disclosing Party

12.1

Dispute

13.8.1

Effective Date

Preamble

Excluded Entity or Excluded Individual

10.4.3

FDA

10.4.5

FDA Disqualified/Restricted List

10.4.5

Force Majeure Event

13.1

Functional Leaders

5.3.1

Joint Project Team or JPT

5.3.1

JSC

5.2

[***] Products

8.1

Joint Patent

8.2.2

Launch Plan

4.2.4

Losses

11.1

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Confidential Treatment Requested by Achaogen, Inc.

 

Definition

Section

Microgenics

Preamble

Microgenics Indemnified Parties

11.1

Microgenics Inventions

8.1

Minimum Threshold

4.2.3

Minimum Threshold Period

4.2.3

Party or Parties

Preamble

Plazomicin Commercialization Plan

4.2.1

Receiving Party

12.1

Regulatory Finding

3.3.1.2

Regulatory Leader

5.3.1

Responsible Party

8.3.1

Review Party

8.3.1

Supply Resumption Date

4.3.2.2

Term

9.1

Third Party Claims

11.1

VAT

7.3.2

 

 

2Research and Development Collaboration

 

2.1Project Plan.  The Parties shall collaborate on the Research Program in
accordance with the Project Plan, as set forth as Exhibit F. As may be necessary
or reasonable from time-to-time, the JPT may suggest appropriate revisions to
the Project Plan to the JSC for its review in accordance with Section 5.3.2 and,
if approved by the JSC in accordance with Section 5.1, the Project Plan may be
amended from time to time by the JSC.

 

2.2Party Responsibilities.

 

2.2.1General.  Microgenics and Achaogen shall each perform their respective
obligations under the Research Program, using Commercially Reasonable Efforts,
in accordance with the Project Plan and in compliance with Applicable Law.

 

2.2.2Achaogen.  Achaogen shall supply to Microgenics, [***], (a) Achaogen
Materials, including Plazomicin and Plazomicin clinical patient samples, in such
quantities as are set forth in Exhibit A or otherwise mutually agreed by the
Parties or set forth in the Project Plan; and (b) all necessary and in
Achaogen’s possession Plazomicin pharmacological and biochemical information,
including [***] etc., to enable the JPT to correctly design the Assay and
Microgenics to work with the appropriate Regulatory Authorities to secure
Regulatory Approval for the Assay. Microgenics shall not transfer any portion of
the Achaogen Materials to any Third Party or use the Achaogen Materials for any
purpose other than the purposes of performing its obligations under, and in
accordance with, this Agreement and the applicable Project Plan. Microgenics
shall hold, store and transport all supplies of the Achaogen Materials in
compliance with all Applicable Laws and [***]. Microgenics shall maintain
complete and accurate records relating to the disposition of all Achaogen
Materials.  

 

2.2.3Microgenics.  Subject to the provisions of this Agreement (including
Article 3 (Regulatory Submissions and Meetings)), Microgenics shall be
responsible for the research, development, manufacture and sale of the Assay.
Microgenics shall manufacture the Assay according to the Specifications

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attached hereto as Exhibit G (which may be amended from time to time by the JSC
in accordance with Section 5.1) and in accordance with the timelines set forth
in the Project Plan. Without limiting the foregoing, Microgenics shall develop
and commercialize the Assay such that it is capable of being run on no less than
[***] ([***]) distinct [***] platforms, which [***] platforms shall be mutually
agreed upon by the Parties in good faith.  

 

2.3Information Exchange, Records and Compliance.

 

2.3.1Technology Transfer.  Achaogen shall provide Microgenics with all Achaogen
Know-How [***] reasonably necessary for Microgenics to carry out its
responsibilities under the Research Program and to obtain Regulatory Approvals
for the Assay. Microgenics shall provide Achaogen with all Microgenics Know-How
[***] reasonably necessary for Achaogen to carry out its responsibilities under
the Research Program and to conduct clinical trials of Plazomicin. All
information exchanged shall be subject to the confidentiality requirements set
forth in Article 12 (Confidentiality) hereof.  

 

2.3.2Record Keeping/Compliance.  During the Term and for a period of [***]
([***]) years thereafter (or such longer period of time as required by
Applicable Laws), each Party shall maintain records in sufficient detail and in
good scientific manner appropriate for obtaining and maintaining Regulatory
Approvals. Achaogen shall have the right (either by itself or through a Third
Party reasonably acceptable to Microgenics), during normal business hours and
upon reasonable notice, to inspect records pertinent to Microgenics’ obligations
under this Agreement. To the extent such records contain Confidential
Information of Microgenics, Achaogen shall maintain such Confidential
Information disclosed therein in confidence in accordance with Article 12.
Achaogen shall have the right to arrange for its employee(s) and/or
consultant(s) involved in the activities contemplated hereunder, during normal
business hours and upon reasonable notice, to discuss the development activities
and results contemplated under this Agreement in detail with the technical
personnel and consultant(s) of Microgenics. Each Party shall comply with all
applicable GLP, GCP, GMP, ISO 9001 and ISO 13485:2003 requirements and other
Applicable Laws in the conduct of the Research Program and in the activities
contemplated under this Agreement, including the development, manufacture and
commercialization of the Assay.  

 

2.4Installation and Training.  Upon Achaogen’s request, Microgenics shall,
[***], install any necessary equipment and train appropriate staff at clinical
sites designated by Achaogen for the performance of clinical trials by Achaogen,
in connection with obtaining Regulatory Approval for Plazomicin, and in order to
enable such sites to use the Assay in connection with such use of Plazomicin and
provide training for such sites’ personnel on how to operate such equipment. For
clarity, [***] shall be [***] responsible for the costs of (a) any clinical
trials conducted for purposes of obtaining Regulatory Approval for the Assay (as
opposed to Regulatory Approval for Plazomicin) and (b) any activities conducted
in a given country in the Territory following the receipt of Regulatory Approval
for the Assay for such country (e.g. commercial activities).

 

2.5Quality Agreement.  No later than [***] ([***]) days after the Effective Date
(or such later date as may be otherwise agreed upon by the Parties in writing),
the Parties shall enter into a quality agreement defining the commitments of
both Parties to ensure that the Assay and related services developed and
commercialized under this Agreement satisfy the quality and regulatory
requirements required by this Agreement.  Microgenics shall manage all Achaogen
Materials (including clinical patient samples) according to customer property
requirements described in such quality agreement.

 

2.6BARDA Requirements.  The Parties acknowledge and agree that Achaogen receives
funding

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from the United States government through the Biomedical Advanced Research and
Development Authority within the office of the Assistance Secretary for
Preparedness and Response in the United States Department of Health and Human
Services (BARDA) in connection with Achaogen’s development of new antibacterial
treatment of MDR gram-negative bacterial infection.  In connection with the
foregoing, the terms and conditions of this Agreement shall be subject in their
entirety to the terms and conditions set forth on Appendix A of Exhibit H.  In
the event of any conflict between the terms and conditions of the main body of
this Agreement and Appendix A of Exhibit H, Appendix A of Exhibit H shall
control.

 

3Regulatory Submissions and Meetings  

 

3.1Coordination.  Achaogen and Microgenics shall [***] coordinate the
therapeutic and diagnostic regulatory filings and communications with Regulatory
Authorities in the Territory. Achaogen will be responsible for all activities
regarding the Regulatory Approval of Plazomicin (and, as between the Parties,
Achaogen shall retain ownership of all regulatory filings and Regulatory
Approvals for Plazomicin), and, subject to the terms and conditions of this
Agreement, [***] will be responsible for all activities regarding the Regulatory
Approval of [***] (and, as between the Parties, [***] shall retain ownership of
all regulatory filings and Regulatory Approvals for [***]). For the avoidance of
doubt, the Parties acknowledge and agree that, notwithstanding anything herein
to the contrary, but subject to Section 3.2 and Section 4.2.7, (a) Achaogen
shall have the sole discretion, at any time during the Term, to determine
whether to conduct any clinical trial or make any regulatory filing, submission
or correspondence with respect to Plazomicin; and (b) [***], subject to Section
4.2.7, at any time during the Term, to conduct any clinical trial (provided,
that, in the event of a clinical trial that involves the use or administration
of [***], [***]) or make any regulatory filing, submission or correspondence
with respect to [***].  

 

3.2Reporting and Consultation.  [***] shall keep [***] regularly informed in
connection with the preparation of all regulatory filings, submissions or
correspondence related to [***] and [***] shall have the right to review and
comment on any regulatory filing, submission or correspondence related to [***]
(including any [***]), to be submitted to any health authority by [***]. In
connection therewith, [***] shall provide to [***] for review the text of any
such regulatory filing, submission or correspondence for [***] prior to
submission and [***] shall consider in good faith all comments provided by
[***]; provided that any disputes with respect to comments provided by [***]
shall be resolved by the JSC. In addition, [***] shall consult with [***] with
respect to all material matters required for regulatory filings, submissions or
correspondence, under this Agreement; provided, however, that, subject to
Section 3.1, [***] shall have sole responsibility hereunder for all regulatory
filings (including [***] or their ex-United States equivalent), submissions or
correspondence, including preparing and analyzing all [***] information required
pursuant to any and all Applicable Laws, and preparing and analyzing any
additional data and information required by any applicable Regulatory Authority
(other than any data or information regarding [***]). Upon written request from
[***], [***] shall promptly provide to [***] copies of all submitted regulatory
filings, submissions, and material correspondence to and from any Regulatory
Authorities; provided, that [***] may redact from such copies information that
does not relate to the Assay, Plazomicin or this Agreement and the activities
hereunder.

 

3.3Correspondence from Regulatory Authority.  

 

3.3.1.1If either Party receives any material communication from the Regulatory
Authorities relating to [***] or has any meetings (telephonic or in person) with
any Regulatory Authority for any material reason regarding [***], such Party
shall promptly notify the other Party and, upon mutual agreement, decide whether
it is necessary for the other Party to be present in any

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discussions with the Regulatory Authorities regarding [***]; provided, however,
that, notwithstanding the foregoing, Achaogen shall have the right to
participate in (a) [***], (b) [***], or (c) [***] pertaining to Achaogen
Materials or Achaogen Know-How. For clarity, as between the Parties, [***] shall
be responsible for leading any meetings or other discussions with the [***].
[***] shall not make any representations or discuss the uses of [***] with any
Regulatory Authority except to the extent it relates to [***]. Neither Party
shall disclose, without the other Party’s prior written consent, Confidential
Information of such other Party in any regulatory filing, submission or
correspondence or at a meeting with any Regulatory Authority, except to the
extent required by Applicable Laws or otherwise under the Project Plan.

3.3.1.2In addition, Microgenics shall notify Achaogen within [***] ([***])
business days of any regulatory finding or violation identified by a Regulatory
Authority that may potentially impact the activities contemplated under the
Project Plan or the development, manufacture or commercialization of the Assay
(a “Regulatory Finding”). With respect to each Regulatory Finding, if any,
Microgenics shall provide (1) (a) [***], or (b) [***], or (c) [***] and (2)
Microgenics’ [***]; provided, that, in each case of clauses (a), (b), and (c),
Microgenics’ may redact from such copies or reports information that does not
relate to the Assay, Plazomicin or this Agreement and the activities hereunder.
Without limiting the next to last sentence of Section 3.5, Microgenics shall
notify Achaogen promptly of any notification or information received from a
Regulatory Authority, that: (i) would reasonably be expected to impair the
integrity or reputation of Plazomicin or the Assay; (ii) raises any material
concerns regarding the safety or efficacy of Plazomicin or the Assay; (iii)
indicates or suggests a potential material liability of either Party to Third
Parties in connection with Plazomicin or the Assay; (iv) is reasonably likely to
lead to a recall or market withdrawal with respect to Plazomicin or the Assay;
or (v) [***].

3.4Package Insert Information.  Notwithstanding anything to the contrary
contained herein, but subject to any applicable review and comment rights of the
other Party, and dispute resolution escalation procedures set forth in Section
13.8, [***] shall have final decision making authority on all package insert
language directed [***], and [***] shall have final decision making authority on
all Assay package insert language directed [***].

 

3.5Filings. On a country-by-country basis, a Regulatory Approval from the
applicable Regulatory Authority(ies) is required for the Assay prior to launch
in such country. Upon Achaogen’s request, Microgenics shall reasonably cooperate
with Achaogen with respect to any regulatory filings, submissions, or
correspondence made by Achaogen related to Plazomicin in any country in the
Territory, including promptly providing data, information and advice regarding
the Assay, including the manufacture (including any recall information) and use
thereof. This Agreement generally assumes that there is a current 510(k) pathway
for obtaining Regulatory Approval for the Assay; provided, that, if a PMA
pathway is required, the Parties acknowledge and agree that [***] reviewed by
the Parties and may need to be adjusted to the extent agreed upon between the
Parties and subject to the proviso in the foregoing sentence. For the avoidance
of doubt, Achaogen shall have sole right to control any such regulatory filings,
submissions, correspondence or other matters related to Plazomicin including any
joint submissions or filings, but not [***], and to communicate with Regulatory
Authorities related thereto. No later than [***] (or such later date as
otherwise agreed to by the Parties), the Parties shall enter into an agreement
setting forth the Parties respective responsibilities for adverse event and
complaint reporting, the exchange of safety data and, to the extent agreed by
the Parties to be appropriate and relevant, recall matters.

 

3.6Right of Reference.  [***] hereby grants to [***] a non-exclusive,
non-transferable (except

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in connection with a permitted assignment, sublicense or subcontract) “right of
reference” (as defined in 21 CFR 314.3(b)) with respect to clinical trial data
and results related to [***], solely as necessary for [***] to prepare, submit
and maintain regulatory submissions related to [***] and Regulatory Approvals
for [***]. [***] hereby grants to [***] a non-exclusive, non-transferable
(except in connection with a permitted assignment, sublicense or subcontract)
“right of reference” (as defined in 21 CFR 314.3(b)) with respect to [***]
clinical trial data (including [***]), information (including the [***], as
applicable) and results related to [***], solely as necessary for [***] to
prepare, submit and maintain regulatory submissions related to [***] and
Regulatory Approvals for [***].

 

3.7[***].  In connection with the [***] of [***] in any [***] in the Territory,
[***] shall [***] of the [***] in [***] in [***] with such [***] of [***]. The
Parties shall discuss in good faith (via the JPT) and mutually agree as to [***]
shall [***] for [***], which discussion and decision shall occur no later than
[***] ([***]) year [***]. In the event that the Parties later agree to [***] for
[***] in a [***], the Parties (through the JPT and JSC) shall amend the Project
Plan to [***], subject to [***], and [***] shall [***].

 

4Manufacture and Commercialization of Assay

 

4.1Manufacture.  Except as provided elsewhere in this Agreement, including
Section 4.3 (Supply) and Section 9.4.4 (Effect of Termination), during the Term,
Microgenics shall be solely and exclusively responsible for the worldwide
manufacture of the Assay in accordance with GMP standards, the Specifications
and Applicable Law.  For clarity, from and after the expiration or termination
of this Agreement, nothing in this Agreement shall restrict Microgenics from
developing, manufacturing or commercializing the Assay as and to the same extent
as any third party.

 

4.2Commercialization.  Upon successful completion of the Development and
Manufacturing Phase and upon receipt of the applicable Regulatory Approval in a
given country in the Territory required in order to sell the Assay in such
country, Microgenics shall use Commercially Reasonable Efforts to exclusively
commercialize and market the Assay, under the Thermo Scientific tradename and
packaging and utilizing Microgenics’ and its Affiliate’s commercial
infrastructure, in each country within the Territory in which Achaogen is
commercializing Plazomicin for so long as Achaogen is commercializing Plazomicin
in such country. Solely to the extent Achaogen elects to promote an assay  which
may be capable of measuring Plazomicin in a given Primary Country ([***]) in the
Territory, and subject to receipt and conditions of any applicable Regulatory
Approvals, Achaogen shall prioritize the promotion of the Assay relative to any
other assay which may be capable of measuring Plazomicin, in its marketing and
sales efforts in such Primary Country; provided, however, that in the event (a)
Microgenics [***] is unable to supply the Assay in quantities sufficient to meet
each applicable Binding Forecast, including [***], or (b) [***], Achaogen may
prioritize the promotion of assays capable of measuring Plazomicin in the
affected country(ies).  For clarity, and notwithstanding anything to the
contrary in this Agreement, including this Section 4.2, Achaogen expressly
reserves and retains the right to, directly or indirectly (including through
contractors or collaborators), research, develop, manufacture, use or
commercialize assays capable of measuring Plazomicin other than the Assay;
provided, that, Achaogen may not, directly or indirectly (including through
contractors or collaborators) commercialize any immunoassay [***], other than
the Assay in accordance herewith, [***]; provided, further, that the restriction
on Achaogen’s right to commercialize immunoassays [***], other than the Assay,
shall be of no force or effect if Microgenics is unable to supply the Assay for
[***] ([***]) days at any time [***] or if the Parties mutually determine
that  Microgenics will not be able to supply the Assay. Additional
commercialization and supply terms may be added to this Agreement in the form of
an amendment.  Without limiting the foregoing:  

 

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4.2.1Plazomicin Commercialization Plan.  As soon as commercially reasonable, but
no later than [***] ([***]) days after the Effective Date of this Agreement,
Achaogen shall share its global commercialization plans for Plazomicin with
Microgenics (“Plazomicin Commercialization Plan”). The Plazomicin
Commercialization Plan shall include the list of countries consistent with the
Primary Country list for commercialization of Plazomicin, anticipated launch
timing, initial volume forecasts and such other information as may be determined
by the JPT. Microgenics will develop timelines on a country basis to the extent
it receives adequate Plazomicin Commercialization Plan details with respect to a
given country. Achaogen agrees to keep such Plazomicin Commercialization Plan
updated via regular communication with the JSC. For clarity, (a) the Plazomicin
Commercialization Plan shall be Confidential Information of Achaogen hereunder,
and (b) Achaogen [***] in preparing and conducting activities under the
Plazomicin Commercialization Plan.

4.2.2Volumes and Pricing.  

4.2.2.1On a regular basis, beginning at least [***] ([***]) months prior to the
anticipated date of the First Commercial Sale of Plazomicin in the Territory,
Achaogen will share confidential, non-binding (except as described below) good
faith volume forecasts in units for the Assay and updates thereof in the
Plazomicin Commercialization Plan through the JSC in order for the Parties to
develop a [***] market introduction including achieving Regulatory Approval
[***] for the Assay in all relevant countries and regions. Thereafter, and on a
[***] basis, Achaogen shall supply Microgenics with a confidential, good faith
rolling [***] ([***]) month forecast (in units, broken-down by country (or
regions)) as to Achaogen’s estimated unit demand for worldwide commercial demand
for the Assay (it being agreed and understood that such forecasts shall be
Confidential Information of Achaogen hereunder); provided, however, only the
first [***] ([***]) months of each [***] ([***]) month forecast shall be binding
(a “Binding Forecast”) and the remaining [***] ([***]) months of such forecast
shall be non-binding (for clarity, when each [***] forecast update is provided,
[***] of the previous forecast (i.e., [***] of the Binding Forecast previously
submitted) shall not be changed as they become [***] of the current forecast and
[***] of the current Binding Forecast). For clarity, except as otherwise
provided in this Agreement with respect to the Binding Forecast, Achaogen shall
have no liability whatsoever with respect to such forecasts, including no
liability for any Assay manufactured or materials ordered by or on behalf of
Microgenics based on such forecasts. Microgenics shall supply the quantities of
the Assay set forth in the applicable Binding Forecasts and shall use
Commercially Reasonable Efforts to ensure that [***], in each case, in
accordance with Section 4.3; provided, however, [***].

4.2.2.2The Parties acknowledge and agree that [***] shall have [***] with
respect to the pricing of the Assay in any country in the Territory; provided,
however, [***] shall [***] to price the Assay in a given country at an amount no
greater than (i) (a) $[***] in the United States or (b) $[***] in any other
country, or (ii) [***] percent ([***]%) of the applicable list price of any
other [***] assay marketed in such country; provided, further, that [***] shall
[***]  to take into account [***].  In the event that (x) [***] to price the
Assay at an amount greater than the foregoing subclauses (i) and (ii), then the
JSC shall review the available data and discuss the Assay price in accordance
with Section 5.2.1(h), and/or (y) the Assay pricing [***], the JSC will review
the available data and discuss various alternative solutions.  

4.2.3Minimum Thresholds.  In the event that, during the applicable Minimum
Threshold Periods (as defined below), Microgenics does not receive the
applicable Minimum Threshold Revenue (as defined below) during a given calendar
year, Achaogen agrees to pay [***] Microgenics for such region during such
calendar year (on a prorated basis, as applicable). For purposes of this Section
4.2.3,

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4.2.3.1The “First Minimum Threshold Period” shall begin on the [***] ([***])
anniversary of the date on which the First Commercial Sale of the Assay in [***]
occurred and shall end on the [***] ([***]) anniversary of the date on which the
First Commercial Sale of the Assay in [***] occurred. For example, if the First
Commercial Sale of the Assay in [***] occurred on [***] then the First Minimum
Threshold Period would begin on [***] and would end on [***];  

4.2.3.2The “Second Minimum Threshold Period” shall begin on the [***] ([***])
anniversary of the earlier of the date on which the First Commercial Sale of the
Assay occurred in (i) [***] of the following countries – [***] (each an “[***]
Country”); or (ii) an [***] Country and [***]; or (iii) [***] ([***]) of the
Primary Country list ([***]) (subclause (i), (ii), or (iii), as applicable, the
“Start Date”), and shall end on the earlier of (a) the [***] ([***]) anniversary
of the Start Date or (b) the date this Agreement expires or terminates;

4.2.3.3“Minimum Threshold Revenue” shall mean, with respect to each of the First
Minimum Threshold Period and the Second Minimum Threshold Period, USD $[***] of
annual gross revenue received by Microgenics from sales of the Assay in the
Territory (for clarity, during any overlap between the First Minimum Threshold
Period and the Second Minimum Threshold Period, the total Minimum Threshold
Revenue would be USD $[***]); provided, however, that the Minimum Threshold
Revenue (i) shall be determined by [***] for a given Assay, less [***] directly
associated with such sale and Assay and permitted to be taken in accordance with
generally accepted accounting principles in the United States, and (ii) that in
the event the Minimum Threshold Period begins or ends during a given calendar
year, the Minimum Threshold Revenue for such calendar year shall be prorated
accordingly.   

4.2.4Market Introduction.  The Parties will reasonably agree regarding details
related to commercialization of the Assay once the [***] are clarified by
Achaogen in the Plazomicin Commercialization Plan. Within [***] ([***]) months
of receiving the initial Plazomicin Commercialization Plan, Microgenics will
provide Achaogen with (a) a detailed market introduction plan for the Assay (the
“Launch Plan”) and (b) a global commercialization plan for the Assay, in a form
to be determined by the JSC (the “Assay Commercialization Plan”). During the
Term, Microgenics shall provide Achaogen [***] with (i) an updated Launch Plan
[***], and (ii) an updated Assay Commercialization Plan [***]. For clarity, (i)
the Launch Plan and Assay Commercialization Plan shall be Confidential
Information of Microgenics hereunder, and (ii) Microgenics is [***] in preparing
and conducting activities under the Launch Plan and Assay Commercialization
Plan.

4.2.5Geographies.  Other than the Primary Countries set forth on Exhibit E, the
Parties shall mutually agree upon any Secondary Countries where Achaogen plans
to introduce Plazomicin, which such Secondary Countries shall thereafter be
deemed to be Primary Countries and included in the Plazomicin Commercialization
Plan and the Assay Commercialization Plan, in all cases no later than [***]
prior to the anticipated launch of Plazomicin in any such country; provided,
however, the parties agree that actual product registration may take longer than
[***] ([***]) months.  

4.2.6Selling, Marketing and Customer Support to Clinical Labs.  Microgenics will
establish and maintain a commercial infrastructure for the supply of the Assay,
as well as adequate product support, customer support and regulatory support in
each market where the Assay is introduced, including [***]. For clarity,
Achaogen [***] the Assay to physicians and other prescribers and related
individuals and organizations; provided, that, for clarity, Microgenics [***] of
the Assay to any such physicians or other prescribers or related individuals and
organizations.  

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4.2.7Abandoned or Uninitiated Development or Commercialization of Assay.  

4.2.7.1If, during the Term, Achaogen determines in good faith that Microgenics
has ceased to develop, commercialize and market the Assay in a specific country
within the Territory in which Achaogen has obtained or is in the process of
obtaining Regulatory Approval for Plazomicin for a period of at least [***]
([***]) months (“Abandoned Commercialization” or “Abandoned Development,” as
applicable), then Achaogen may deliver to Microgenics written notice that
Achaogen deems Microgenics to have Abandoned Commercialization. If Achaogen
delivers such written notice to Microgenics, such notice shall set forth the
basis for Achaogen’s good faith determination. If Microgenics disagrees with
Achaogen’s determination that Microgenics has Abandoned Commercialization, then
the Parties will meet within [***] ([***]) business days to discuss such
disagreement. If the Parties cannot agree after such discussion, then the terms
of Section 13.8 shall apply to resolve such Dispute.  

4.2.7.2If it is finally determined pursuant to the procedures set forth in
Section 4.2.7.1 that Microgenics has Abandoned Commercialization, then, within
[***] ([***]) business days of such determination, Microgenics will
commercialize and market the Assay for [***] ([***]) months after the written
determination is received.  After the [***] ([***]) months period has expired,
Microgenics will continue to supply the Assay to Achaogen or its distributor
pursuant to the terms of a supply agreement that the Parties will negotiate
during the first [***] ([***]) months of the [***] month period described in the
prior sentence; provided, that such supply agreement shall include an initial
(i.e., for a period of no less than [***] ([***]) months) supply price that is
no greater than [***] ([***]%) of the lowest price at which Microgenics has made
the Assay available to its distributors, or any Third Party if there is no
distributor, in the affected country.   Microgenics shall [***] promptly assist
Achaogen (and/or its designee) in obtaining all necessary Regulatory Approvals
and/or modifying and/or transferring existing Regulatory Approvals to enable
Achaogen (and/or its designee) to develop, make, have made, use, market,
distribute, import, sell and offer for sale the Assay ([***]) in any applicable
country.

4.2.7.3Solely in the event of Abandoned Development, the Parties acknowledge and
agree that this Agreement does not supersede Section 5.3 of the Antibody
Development Agreement and that Achaogen reserves all of its rights under Section
5.3 of the Antibody Development Agreement, including in the event of Abandoned
Development.

4.3Supply.  

 

4.3.1Clinical Supply.  Microgenics shall supply to Achaogen the amount of Assay
ordered by Achaogen, if any, for use in any clinical trials or other development
of Plazomicin in accordance with the delivery and shipment terms set forth in
the Project Plan to the extent applicable. Achaogen shall provide to Microgenics
confidential, non-binding good faith clinical trial and other development supply
forecasts for each [***] ([***]) month period starting on [***] and [***] of
each calendar year and shall deliver each forecast in writing at least [***]
([***]) days prior to the commencement of the applicable [***] ([***]) month
period. The Parties shall agree on the exact date for the delivery of such
Assay. Achaogen shall reimburse Microgenics at (a) a price of USD $[***] per
patient result used to make diagnostic decisions for the applicable patient or
(b) in the event the Assay is being commercialized at the time of supply, [***];
provided, however, in each case, if Microgenics utilizes any data from any
clinical trial or other study conducted by Achaogen with Assay supplied under
this Section 4.3.1, Achaogen shall have no obligation to reimburse Microgenics
for such Assay.    

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4.3.2Continued Supply.  

4.3.2.1Microgenics shall ensure the continued worldwide supply of the Assay in
quantities at least sufficient to meet each applicable Binding Forecast. Without
limiting the foregoing, Microgenics agrees to maintain a safety stock of rare
reagents sufficient to meet each applicable Binding Forecast for the Assay.
Microgenics shall provide Achaogen at least [***] ([***]) months (or [***])
prior written notice of any possible shortfall in meeting each applicable
Binding Forecast or other commercial demand for the Assay, and the Parties shall
promptly meet and discuss all reasonable commercial resolutions if Microgenics
is unable to assure supply as needed to meet each applicable Binding Forecast
pursuant to the terms set forth in Section 4.3.2.2.  

4.3.2.2In addition, in order to ensure security of supply of the Assay, within
[***] of Microgenics’ receipt of the first Regulatory Approval for the Assay in
any country in the Territory, Microgenics shall designate [***] (the “Back-up
Supplier”) which such Back-up Supplier shall be and remain qualified as a
manufacturer of the Assay for the supply of the Assay for sale in the
Territory.  Microgenics shall [***] ensure that the Back-up Supplier can supply
the Assay for sale in the Territory within [***] days.  Microgenics will develop
a manufacturing transition plan that will highlight [***] needed to complete the
transition to the back-up supplier.  This plan will be presented to the JSC
prior to first commercial launch of the Assay.

4.3.2.3If, for any reason, [***], both Microgenics and the Back-up Supplier (as
applicable) are unable to supply the Assay in quantities sufficient to meet the
quantities of the Assay either (a) as set forth in each applicable Binding
Forecast or (b) based on such other measure of commercial demand as agreed to by
the Parties in writing, in either case, during any given [***] ([***]) month
period for a given country in the Territory, then Microgenics hereby grants
Achaogen or its designee a Shortfall License, which license shall survive until
[***] ([***]) months following the date that either Microgenics or the Back-up
Supplier (as applicable) is in a position again to fulfill such demand (as such
positioning is demonstrated [***]) (the “Supply Resumption Date”). The Shortfall
License shall expire automatically [***] ([***]) months after the Supply
Resumption Date; provided, however, that (a) Achaogen shall be entitled to use,
sell, offer for sale, and import any assay that are in inventory prior to the
expiration of the Shortfall License (even if such activity occurs after
expiration of the Shortfall License). Additionally, [***], Microgenics shall (i)
make its personnel available for a reasonable period of time (not to exceed
[***] ([***]) months) to effect a successful technology transfer with respect to
the manufacture and commercialization of such Assay under the terms of this
paragraph, (ii) provide Achaogen with copies of the physical embodiment of all
processes, protocols, procedures, methods, tests and other intellectual property
rights licensed to Achaogen under the Shortfall License, as applicable, related
to Assay (including the manufacture thereof), (iii) supply [***] (including
[***]) reasonably required to perform [***] as may be required by the applicable
Regulatory Authorities, and upon request by Achaogen, [***], provide Achaogen
(and/or its designee) with [***] related to the Assay, and (iv) promptly assist
Achaogen (and/or its designee) in obtaining all necessary Regulatory Approvals
and/or modifying and/or transferring existing Regulatory Approvals to enable
Achaogen (and/or its designee) to develop, make, have made, use, market,
distribute, import, sell and offer for sale the Assay ([***]).  

4.4Audit Rights.  

 

4.4.1[***] during the Term, commencing on the [***] ([***]) [***] of the
Effective Date, Achaogen shall have the right to inspect and audit [***] per
calendar year (either by itself or through a Third Party reasonably acceptable
to Microgenics) the Assay manufacturing process, facilities, procedures,

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and records upon reasonable notice (which shall be no less than [***] ([***])
calendar days prior notice, unless a shorter period is mutually agreed to by the
Parties), and during normal business hours. Notwithstanding the foregoing,
Achaogen shall have the right to conduct “for cause” audits (either by itself or
through a Third Party reasonably acceptable to Microgenics) [***] during normal
business hours of the [***], including in the event of a failure to supply the
Assay as specified under Section 4.3.2. Any information shared with Achaogen or
a Third Party under this Section 4.4.1 shall be considered Confidential
Information. In connection with any such inspection or audit, Microgenics shall
have no obligation to provide Achaogen and/or a Third Party access to
Microgenics’ Confidential Information related to any product other than the
Assay.  

 

4.4.2Additionally, during the Term, Microgenics shall inform Achaogen within
[***] ([***]) business days after receipt of any notice of an audit or
inspection by ay Regulatory Authority which directly or indirectly relates to
the Assay or the Assay manufacturing or distribution operations and Microgenics
shall promptly provide to Achaogen in writing the results of any such audit or
inspection within [***] ([***]) business days of receipt, including (a) a copy
of any inspection reports, Form 483s, warning letters or similar such reports or
warnings (“Audit Outcome”), to the extent such Audit Outcome solely addresses
the Assay, or (b) a summary of such Audit Outcome, including verbatim text
copies of portions thereof pertaining to the Assay, to the extent such Audit
Outcome addresses the Assay and other matters, or (c) a summary of such Audit
Outcome, to the extent that the Assay is not mentioned in such Audit Outcome;
provided, that, in each case of clauses (a), (b), and (c), Microgenics’ may
redact from such copies or reports information that does not relate to the
Assay, Plazomicin or this Agreement and the activities hereunder, and a summary
of Microgenics proposed strategy for addressing any issues or violations noted
during the course of such audit or inspection.

 

4.5Labeling.

 

4.5.1Assay Labeling.  Microgenics shall be responsible for ensuring that all
Assay packaging and labeling are in compliance with its Regulatory Approvals and
Applicable Law.

 

4.5.2Information for Labeling and Promotional Materials for Plazomicin.  At the
request of Achaogen, Microgenics shall provide to Achaogen such information
related to the Assay which is in Microgenics’ possession, for Achaogen’s use and
reference in the packaging and labeling (including package insert) and
promotional materials for Plazomicin.  

4.5.3Changes to Labeling.  Achaogen will promptly notify Microgenics of any
changes to Plazomicin labeling relevant for the Assay, including [***]. [***],
such changes will be implemented by Achaogen with [***] in order to allow
Microgenics to change any labeling on the Assay as a result of such changes to
Plazomicin labeling. Similarly, Microgenics will promptly notify Achaogen of any
changes to the Assay labeling, and Microgenics will implement such changes with
[***] in order to allow Achaogen to change any labeling on Plazomicin as a
result of such changes to the Assay labeling; provided, however, that
Microgenics shall not make any such changes directed to Plazomicin (including,
[***]) or which would otherwise require a change to the labeling for Plazomicin,
without Achaogen’s prior written approval.

5Governance.  

 

5.1Alliance Managers.  

 

5.1.1No later than [***] ([***]) days after the Effective Date, each of the
Parties shall

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appoint one (1) representative as its alliance manager (“Alliance Manager”). The
Alliance Managers shall have the right to attend all JSC and JPT meetings as
non-voting participants and may bring to the attention of the JSC or JPT any
matters or issues either of them reasonably believes should be discussed, and
shall have such other responsibilities as set forth in Section 5.1.2 or as the
Parties may mutually agree. Each Party may replace its Alliance Manager at any
time or may designate different Alliance Managers by notice in writing to the
other Party.  

 

5.1.2The Alliance Managers shall have responsibility for creating and
maintaining a constructive work environment between the Parties. Without
limiting the generality of the foregoing, each Alliance Manager shall:

 

5.1.2.1identify and bring disputes and issues, including disputes that cannot be
resolved by the JPT, that may result in disputes to the attention of the JSC in
a timely manner, and function as the point of first referral in all matters of
conflict resolution. In doing so, it is not intended that the Alliance
Manager(s) act as a substitute for, or insert any delay in, the formal dispute
resolution mechanisms set forth in Section 13.8, but rather that the Alliance
Manager(s) shall endeavor to maintain a positive and constructive relationship
between the Parties at the working level;

 

5.1.2.2provide a single point of communication for seeking consensus both
internally within the Parties’ respective organizations and between the
Parties;  

5.1.2.3plan and coordinate cooperative efforts, internal communications and
external communications between the Parties with respect to this Agreement; and

5.1.2.4take responsibility for ensuring that meetings and the production of
meeting agendas and minutes occur as set forth in this Agreement, and that
relevant action items resulting from such meetings are appropriately carried out
or otherwise addressed.

5.2Joint Steering Committee.  The Parties agree that the Research Program shall
be managed by a Joint Steering Committee (“JSC”) and that the JSC shall
otherwise have responsibility for the general oversight of activities hereunder.
No later than [***] ([***]) days after the Effective Date, each of the Parties
shall appoint two (2) representatives to the JSC. The JSC shall be led by two
(2) co-chairs, one (1) appointed by Microgenics and one (1) appointed by
Achaogen. The JSC will make decisions by consensus, with Microgenics and
Achaogen each having one vote. In the event of an impasse, the matter shall be
resolved pursuant to Section 5.2.3 (Decision-Making). A Party may change any of
its representatives at any time by giving [***] ([***]) days prior written
notice to the other Party.

 

5.2.1Responsibilities.  In addition to its general responsibility to oversee and
coordinate the development of the Assay according to the Project Plan and to
assure the regular flow of information between the Parties, the JSC shall:

 

(a)

develop the Project Plan, monitor the progress of the Research Program, and
review and approve all proposed changes to the Project Plan;

 

(b)

amend the Specifications for the Assay;

 

(c)

review and approve the [***] in accordance with Section [***] hereof;

 

(d)

oversee the activities of the JPT;

 

(e)

review and approve the most appropriate regulatory pathway for obtaining
Regulatory

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Approval of the Assay;

 

(f)

review and approve the contents of all applications for Regulatory Approval and
related and supporting submissions to Regulatory Authorities;

 

(g)

develop and manage clinical samples supply;

 

(h)

discuss pricing policy for the Assay in the Territory, including [***] and
similar matters, to the extent permitted under Applicable Law; provided that,
for clarity, [***];

 

(i)

resolve disputes escalated by the Alliance Managers; provided that, if after
[***], the JSC is unable to resolve any such dispute, such dispute shall be
resolved in accordance with Section 5.2.3.2;

 

(j)

confirm completion of each event described in Section 7.1 if the Joint Project
Team has not agreed that a Milestone has been completed; and

 

(k)

manage and coordinate the supply and commercialization of the Assay, including
the initial commercial launch of the Assay and monitoring the progress of the
Assay Commercialization Plan and Launch Plan.

 

5.2.2Meetings.  The JSC shall meet at least [***] during the Term at such place
and time as is agreed upon by the Parties; provided, however, that in the event
of an emergent situation, including a situation in which a decision by the JSC
is required, a meeting shall be held within [***] ([***]) days after written
request for such meeting by either Party. Meetings of the JSC may be conducted
in person, by telephone or videoconference as agreed by the JSC or the Parties.
When held in person, the location of the meetings shall alternate between
Achaogen’s facilities and Microgenics’ facilities, unless otherwise mutually
agreed by the Parties. The Alliance Managers shall be responsible for planning
and scheduling the meetings and preparing the agenda. The Alliance Managers will
record the minutes of each meeting (alternating between Achaogen and
Microgenics). Minutes of each meeting of the JSC shall be exchanged for review,
comment and approval by the members; provided that, if after [***] ([***]) days
following the distribution of the minutes, neither Party has raised any
objection, the minutes shall be deemed to have been approved by the Parties.
Thereafter, the minutes shall be signed by the co-chairs and distributed to each
of the Parties. Additionally, upon invitation by the JSC, the Functional Leaders
(or other JPT members) may attend JSC meetings as non-voting members, and each
JSC member may reasonably invite other guests to the meetings, in order to
discuss special technical or commercial topics relevant to the applicable
agenda; provided, that any guests are subject to the confidentiality provisions
set forth in Article 12 (Confidentiality).

 

5.2.3Decision-Making.  

 

5.2.3.1All decisions of the JSC shall be made in good faith in the interest of
furthering the purposes of this Agreement and the JSC members shall use good
faith efforts to make decisions unanimously.  

 

5.2.3.2If the JSC is unable to agree on any matter after good faith attempts to
resolve such disagreement [***], then for matters that are [***], the JSC may
refer the disagreement to a meeting between a senior executive (other than a JSC
member) representing each Party (currently [***] for Achaogen and [***] for
Microgenics) which meeting shall take place as soon as practicable, but in no
event later than [***] ([***]) days after the date of the relevant referral. If
the senior executives for Achaogen and Microgenics cannot resolve such
disagreement over such [***] matter in a mutually acceptable manner within [***]
([***]) business days after such meeting then the matter shall be decided in
accordance with Section 13.8.2. Notwithstanding the foregoing, except as
otherwise provided in, and subject to the terms and conditions of, this
Agreement: (a) [***], with appropriate consideration of the interests of [***],
will have [***] that impact the development,

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manufacture or marketing of [***] and (b) [***], with appropriate consideration
of the interests of [***], will have [***] that [***] impact the development,
manufacture or marketing of [***]; provided, that, [***] shall not have
decision-making authority regarding (i) [***], or (ii) [***], which such
decisions shall require the mutual agreement of the Parties, or (iii) [***]
(which the Parties acknowledge will be ultimately dictated by [***]), or (iv)
[***].  

 

5.2.4Expenses.  Microgenics and Achaogen shall be responsible for all expenses
incurred by its JSC members in connection with performing their duties
hereunder, including all costs of travel, lodging and meals.

 

5.2.5No Authority to Amend.  For the avoidance of doubt, the JSC (and any Party
exercising decision-making authority under Section 5.2.3.2) shall not have the
authority to amend this Agreement, but the JSC shall have authority to amend the
Project Plan and the Specifications as expressly set forth herein (and, for
clarity, [***] shall not have decision-making authority with respect to any
[***]).

 

5.3Joint Project Team; Functional Leaders.  

 

5.3.1Formation.  The Parties shall form a joint project team (the “Joint Project
Team” or “JPT”). The JPT shall be comprised of a total of six (6) project team
members from Microgenics and Achaogen, with Microgenics and Achaogen each
designating a development leader, a regulatory leader, and a commercial leader
(respectively, the “Development Leader”, the “Regulatory Leader” and the
“Commercial Leader”, and collectively, the “Functional Leaders”) who shall be
the principal point of contact for each Party for matters relating to its
respective function, and shall be responsible for implementing and coordinating,
on a day-to-day basis, all activities and facilitating the exchange of
information between the Parties regarding the Project Plan for his or her
function. Notwithstanding the foregoing, the Regulatory Leaders and Commercial
Leaders may be appointed at such time as the Parties deem appropriate to
facilitate the development of the Assay and a successful commercial launch of
Plazomicin and the Assay.

 

5.3.2Responsibilities.  The JPT shall have responsibility for coordinating all
development, regulatory, commercial and other business and technical activities
under this Agreement. In addition to its general responsibility to deliver the
development of the Assay according to the Project Plan and to assure the regular
flow of information between the Parties, the JPT shall:

 

 

(a)

recommend changes to the Project Plan, Launch Plan and Assay Commercialization
Plan to the JSC,

 

(b)

monitor the activities vs budget to the JSC,

 

(c)

recommend changes to the Specifications for the Assay to the JSC;

 

(d)

communicate progress to the JSC;

 

(e)

plan the regulatory pathway for obtaining Regulatory Approval of the Assay; and

 

(f)

prepare all applications for Regulatory Approval and related and supporting
submissions to Regulatory Authorities.

 

5.3.3Members.  No later than [***] ([***]) days after the Effective Date, each
Party shall provide the other with the names of its JPT members and Functional
Leaders (other than the Regulatory Leaders and Commercial Leaders). Microgenics
and Achaogen may replace its JPT members and Functional Leaders at any time and
for any reason upon written notice to the other Party.

 

5.3.4Sub-Teams.  The JPT and Functional Leaders may delegate tasks and

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responsibilities to sub-managers, working groups and other team members as they
deem appropriate to efficiently and effectively perform their respective
obligations hereunder.  

 

5.3.5Meetings.  The JPT shall meet as soon as practicable after the Effective
Date and thereafter during the performance of the Project Plan, at least [***],
and at such additional times as the JPT or the Parties reasonably deem
appropriate; provided, that, following the completion of the Project Plan, the
JPT shall continue to meet no less frequently than [***]. Meetings of the JPT
may be conducted in person, by telephone or videoconference as agreed by the JPT
or the Parties. Additionally, the JPT and the Functional Leaders (or their
designees) shall maintain close regular communications with each other as to the
status of the ongoing and planned activities under the Project Plan, Launch Plan
and Assay Commercialization Plan. Each JPT member may reasonably invite other
guests to the meetings, in order to discuss special technical or commercial
topics relevant to the applicable agenda; provided, that any guests are subject
to the confidentiality provisions set forth in Article 12.  

 

5.3.6No Authority to Amend.  Neither the JPT nor the Functional Leaders (or
their designees) shall have authority to amend this Agreement or the Project
Plan, but may make recommendations regarding such amendments to the JSC.

 

5.3.7Dispute Resolution.  The JPT and the Functional Leaders will cooperate with
each other and work in good faith to resolve any disagreements between them or
their respective teams. Any such disagreements that are not resolved by the JPT
shall be raised to the Alliance Managers for internal escalation if needed.

 

5.3.8Records.  The JPT shall keep accurate and complete records of their
activities and meetings and shall, from time to time as requested by the JSC,
provide the JSC with appropriate updates and information to keep the JSC
apprised of the progress of the Project Plan, Launch Plan and Assay
Commercialization Plan. All records of the JPT that are disclosed to the other
Party and which relate to the Project Plan shall be available at all times to
the JSC and to each Party on a confidential basis solely for use with respect to
such Party’s activities conducted pursuant to this Agreement.  

 

5.3.9Expenses.  Microgenics and Achaogen shall be responsible for all expenses
incurred by its JPT members in connection with performing their duties
hereunder, including all costs of travel, lodging and meals.

 

5.4Reporting.  The Parties shall keep each other promptly informed on an ongoing
basis through the Joint Project Team and the JSC on the progress of the Project
Plan, the Launch Plan and the Assay Commercialization Plan, including forecasts
of expected performance and completion of activities. Without limiting the
foregoing, within [***] ([***]) days following [***] of each calendar year
during the Term, Microgenics shall provide to Achaogen a written progress report
in English, in a form to be agreed upon by the JSC, which shall include any
information required under the Project Plan and as otherwise reasonably
determined by the JSC relating to the progress of the goals or performance of
the development, commercialization and other activities under the Project Plan,
the Launch Plan and the Assay Commercialization Plan.  

 

6Grant of License

 

6.1Exclusive License by Achaogen.  During the Term, and without limiting Section
4.2, Achaogen hereby grants to Microgenics a royalty-free, exclusive, worldwide
license to use the Achaogen

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Know-How, Achaogen Patents, and Achaogen Materials to research, develop,
manufacture, use, market and sell the Assay in the Territory. [***].  

 

6.2License by Microgenics.  During the Term, Microgenics hereby grants to
Achaogen and its Affiliates a royalty-free, non-exclusive, sub-licenseable,
worldwide license, under and with respect to the Immunoassay Technologies,
Microgenics Know-How and any Patents or Patent applications Controlled by
Microgenics or its Affiliates to the extent reasonably necessary for Achaogen to
perform its obligations or exercise its rights under this Agreement or as is
otherwise reasonably necessary to make, have made, use, sell, offer for sale,
import and otherwise commercialize Plazomicin. For the avoidance of doubt, the
foregoing license grant does not provide any license or right for Achaogen to
make, have made, use, sell, offer for sale, import or otherwise commercialize
the Assay, except in connection with Achaogen’s exercise of the Shortfall
License or Transfer License.

 

6.3[***] Products and Joint Patents.  Each Party shall be entitled to grant
non-exclusive licenses to any Third Party under its interest in a [***] Products
or Joint Patent [***]. [***], and if in certain countries the grant of a
license, in order to be effective, requires declarations from the other Party,
the other Party shall reasonably cooperate and provide the necessary
declarations.  

 

6.4No Implied License.  Achaogen retains all rights in and to the Achaogen
Patents and Achaogen Know-How. Microgenics retains all rights in and to the
Immunoassay Technologies and Microgenics Know-How. Only the licenses and other
rights expressly granted by one Party to the other Party under terms of this
Agreement are of any legal force or effect. No other licenses or other rights
are granted, conveyed or created (whether by implication, estoppel or
otherwise).

 

7Consideration to Microgenics  

 

7.1Development Payments.  In consideration of the development efforts of
Microgenics under the Research Program, Achaogen shall pay to Microgenics the
following one-time payments upon the occurrence of the corresponding events:  

 

 

(a)

USD $[***] upon the successful completion of Phase 0: [***] as determined in
accordance with the Project Plan, including delivery by Microgenics of all
deliverables required by the Project Plan for Phase 0;

 

 

(b)

USD $[***] upon the successful completion of Phase 1: [***] as determined in
accordance with the Project Plan, including delivery by Microgenics of all
deliverables required by the Project Plan for Phase 1;

 

 

(c)

USD $[***] upon the successful completion of Phase 2: [***] as determined in
accordance with the Project Plan, including delivery by Microgenics of all
deliverables required by the Project Plan for Phase 2;

 

 

(d)

USD $[***] upon the successful completion of Phase 3: [***] as determined in
accordance with the Project Plan, including delivery by Microgenics of all
deliverables required by the Project Plan for Phase 3;

 

 

(e)

USD $[***] upon the successful completion of the first milestone of Phase 4:
[***] as determined in accordance with the Project Plan, including delivery by
Microgenics of

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all deliverables required by the Project Plan for the first milestone of Phase
4;

 

 

(f)

USD $[***] upon the successful completion of the second milestone of Phase 4:
[***] as determined in accordance with the Project Plan, including delivery by
Microgenics of all deliverables required by the Project Plan for the second
milestone of Phase 4;

 

 

(g)

USD $[***] upon the successful completion of the third milestone of Phase 4:
[***] as determined in accordance with the Project Plan, including delivery by
Microgenics of all deliverables required by the Project Plan for the third
milestone of Phase 4;

 

 

(h)

[***], USD $[***] upon the successful completion of the fourth milestone of
Phase 4: [***] as determined in accordance with the Project Plan, including
delivery by Microgenics of all deliverables required by the Project Plan for the
fourth milestone of Phase 4;

 

 

(i)

USD $[***] upon the successful completion of the first milestone of Phase 5:
[***] as determined in accordance with the Project Plan, including delivery by
Microgenics of all deliverables required by the Project Plan for the first
milestone of Phase 5;

 

 

(j)

USD $[***] upon the successful completion of the second milestone of Phase 5:
[***] as determined in accordance with the Project Plan, including delivery by
Microgenics of all deliverables required by the Project Plan for the second
milestone of Phase 5;

 

 

(k)

[***]; and

 

 

(l)

[***] and assuming [***], USD $[***] upon [***]; provided, however, this amount
[***].

 

Thereafter, no additional payments shall be due and payable to Microgenics by
Achaogen for any Assay [***].

 

7.2Invoices; Mechanism of Payment.  Upon the completion of each event as
described in Section 7.1, Microgenics will invoice Achaogen within [***] ([***])
business days. Microgenics agrees to submit invoices to Achaogen (on a timely
basis) for all payments due hereunder. Invoices shall reference Achaogen’s
contract number and the purchase order number. The invoices due under this
Agreement shall be submitted to:

 

Achaogen Inc.

7000 Shoreline Court, #371

South San Francisco, CA 94080

 

Reference: Achaogen Contract No. _____________, Attn.: _______

Email:  

 

All payments due Microgenics under this Agreement shall be made by Achaogen in
United States dollars within [***] ([***]) days after receipt of the applicable
invoice by ACH transfer to the credit and account of Microgenics at the
following account: [***].

 

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7.3Taxes.

 

7.3.1Withholding.  Microgenics shall be liable for all income and other taxes
(including interest) imposed upon any payments made by Achaogen to Microgenics
under this Agreement. In the event that any Applicable Law requires Achaogen to
withhold taxes with respect to any payment to be made by Achaogen pursuant to
this Agreement, Achaogen will notify Microgenics of such withholding requirement
prior to making the payment to Microgenics and provide such assistance to
Microgenics, including the provision of such documentation as may be required by
a tax authority, as may be reasonably necessary in Microgenics’ efforts to claim
an exemption from or reduction of such taxes. Achaogen will, in accordance with
such Law withhold taxes from the amount due, remit such taxes to the appropriate
tax authority, and furnish Microgenics with proof of payment of such taxes
within [***] ([***]) days following the payment.  If taxes are paid to a tax
authority, Achaogen shall provide reasonable assistance to Microgenics to obtain
a refund of taxes withheld, or obtain a credit with respect to taxes paid.

 

7.3.2VAT.  All payments due to Microgenics from Achaogen pursuant to this
Agreement shall be paid exclusive of any value-added tax (“VAT”) (which, if
applicable, shall be [***]). If Microgenics is required to report any such tax,
Achaogen shall promptly provide Microgenics with applicable receipts and other
documentation necessary or appropriate for such report.

 

8Intellectual Property Rights; Ownership

 

8.1Ownership of Discoveries and Inventions.  Achaogen shall own all discoveries
and inventions made by one or both of the Parties as part of the Research
Program, whether or not patentable, relating (i) solely to Plazomicin, the
Achaogen Patents, the Achaogen Know-How, and Achaogen Materials or (ii) [***]
(each of (i) and (ii), “Achaogen Inventions”). Microgenics shall own all
inventions and discoveries made by one or both of the Parties as part of the
Research Program, whether or not patentable, relating solely to Microgenics Cell
Lines, Microgenics [***] Antibodies, the Assay, Immunoassay Technologies and
Microgenics Know-How (“Microgenics Inventions”). For all other inventions and
discoveries, whether or not patentable, made by the Parties as part of the
Research Program, whether individually or jointly, inventorship shall be
determined pursuant to the inventorship principles arising under the patent laws
of the United States of America, [***] (“[***] Products”). Each Party shall
ensure that each of its employees and other representatives performing
activities hereunder has agreed to assign to it all discoveries and inventions
made by such employee or other representative in the course of his or her
employment.  

 

8.2Patent Procurement.  

 

8.2.1Achaogen and Microgenics shall each disclose to the other any inventions
and discoveries made during the course of the Research Program. Achaogen shall
be responsible for the prosecution and maintenance of any Patent applications
and Patents claiming or covering any Achaogen Inventions, and Microgenics shall
be responsible for the prosecution and maintenance of any Patent applications
and Patents claiming or covering any Microgenics Inventions; provided, that
[***] shall not, without first obtaining [***] prior written consent, file any
Patent claiming or covering the [***]; provided, further, that, in the event
that any such Patent applications covering or claiming any [***] are filed
without first obtaining [***] prior written consent, then [***] hereby grants
[***] a perpetual, irrevocable, fully paid-up, royalty-free, worldwide,
sublicenseable, non-exclusive license under such Patent applications and any
Patents issuing therefrom or related thereto for the purpose of developing,
manufacturing, using or commercializing [***].  

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8.2.2With respect to any Patent applications and Patents claiming or covering
any [***] Products, the Parties shall meet to determine in what countries, if
any, Patent applications claiming such [***] Products should be filed and the
appropriate filing Party (a “Joint Patent”). The Parties shall [***] by the
Party filing such patent applications in connection with any Joint Patents. If a
Party elects [***] related to any Joint Patent, the other Party shall provide
written notice upon the decision to [***] and the Party not giving such notice
shall have the right to assume responsibility for any such prosecution or
maintenance, [***].  

 

8.3Prosecution, Review, Cooperation.  

 

8.3.1The Party responsible for prosecuting and maintaining a given Patent
pursuant to Section 8.2.1 or 8.2.2 (i.e., Microgenics with respect to Patents
claiming or covering any Microgenics Inventions and the Assay Patent and the
Party agreed to by the Parties with respect to Joint Patents) (the “Responsible
Party”) shall keep the other Party (the “Review Party”) reasonably informed
regarding the status of the filing, prosecution and maintenance of each
applicable Patents, and shall provide the Review Party with copies of all
documentation concerning each applicable Patent, including all correspondence to
and from any Governmental Authority relating thereto.  Prior to filing an
applicable Patent application for, or material prosecution documents or other
submissions relating to, an applicable Patent, the Responsible Party shall
provide the Review Party with a reasonable opportunity to review and comment on
the proposed application, document or submission, and the Responsible Party
shall reasonably consider all such comments and incorporate such comments.  In
the event that the Responsible Party elects to abandon any applicable Patent,
the Responsible Party shall notify the Review Party in writing (such notice, an
“Abandonment Notice”) at least [***] ([***]) days prior to any filing or payment
due date or any other due date that requires action to prevent loss of rights,
and in the event that the Review Party provides the Responsible Party with
written notice within [***] ([***]) days of receipt of the applicable
Abandonment Notice, the Review Party shall thereafter have the right, [***], to
conduct such filing, prosecution and maintenance for the applicable Patent.

 

8.3.2Each of the Parties shall execute or have executed by its employees,
representatives and agents such documents as may be reasonably necessary to
obtain, perfect, or maintain any Patent rights which would be filed pursuant to
this Agreement and to cooperate with the other Party, [***], as reasonably
necessary with respect to the prosecution of such Patent rights.

 

8.4Ownership.  The Achaogen Patents, Achaogen Know-How and the Achaogen
Materials shall at all times remain the sole property of Achaogen. Microgenics
shall not use the Achaogen Know-How or the Achaogen Materials to develop or
market, or have developed or marketed, any Assay for any Third Party. The
Microgenics Cell Lines, Microgenics [***] Antibodies, Immunoassay Technologies
and Microgenics Know-How shall remain the sole property of Microgenics. Except
as may otherwise be expressly permitted pursuant to the terms and conditions of
this Agreement, Achaogen shall not use the Microgenics Cell Lines, Microgenics
Monoclonal Antibodies, Immunoassay Technologies and Microgenics Know-How to
develop, manufacture, or market, or have developed, manufactured, or marketed,
the Assay or any additional assay(s) for Plazomicin or any other
compound/substance.

 

8.5Enforcement.  Each Party shall immediately notify the other if it becomes
aware of any infringement, anywhere in the world, of any issued Patent within
the Joint Patents. The Parties shall mutually determine whether to take action
to obtain a discontinuance of infringement or bring suit against a Third Party
infringer of any Joint Patents within [***] ([***]) days from the date of
notice; provided that neither

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Party shall be obligated to join any such action. In the event that either Party
does not want to join as a Party plaintiff, then the Party not seeking to
enforce such infringement claims shall have the right to assign the relevant
Joint Patents to the other Party; provided that such assignment is solely and
sufficient for purposes of commencing and maintaining the action. The Party
seeking to enforce such infringement claims [***] of any suit brought by it
claiming infringement of any Joint Patent. The Parties will reasonably
cooperate, at the expense of the Party seeking to enforce such infringement
claim, in any such suit and shall have the right to consult with the other Party
and to participate in and be represented by independent counsel in such
litigation [***]. Any recoveries obtained by Achaogen or Microgenics, as
applicable, as a result of any proceeding against such a Third Party infringer
shall be allocated as follows: (a) such recovery shall first be used to
reimburse each Party for all reasonable attorney fees and other litigation costs
actually incurred in connection with such litigation by that Party, and (b) any
remainder shall be shared [***] by the Parties.  

 

8.6Patent Infringement.  Each Party shall immediately notify the other if a
claim or other proceeding is brought against either Party alleging infringement
of Third Party Patent rights based upon the manufacture, use or sale of the
Assay. The Parties shall immediately consult on how to proceed with respect to
defending against any such claim of infringement.

 

8.7Third Party Licenses.  Microgenics shall be solely responsible, at its own
expense, for obtaining rights under any Third Party intellectual property
necessary for Microgenics to perform its obligations under this Agreement and
Achaogen shall be under no obligation to provide support therefor, financial or
otherwise.

 

8.8Trademarks.  As between the Parties, Microgenics shall own all right, title
and interest in and to any Trademarks developed by or for Microgenics for use in
connection with the Assay. Microgenics hereby grants to Achaogen a royalty-free
non-exclusive right to use such Trademarks in connection with advertising,
promoting and marketing Plazomicin, subject to Section 12.5 (Non-Use of Names).
All use of Microgenics’ Trademarks by Achaogen shall inure to the sole benefit
of Microgenics. As between the Parties, Achaogen shall own all right, title and
interest in and to all Trademarks developed by or for Achaogen for use in
connection with Plazomicin.

 

9Term and Termination

 

9.1Term.This Agreement shall be effective as of the Effective Date and unless
terminated earlier by mutual written agreement of the Parties or pursuant to
Section 9.2 (Termination At Will) or Section 9.3 (Termination for Cause) below,
the term of this Agreement shall continue in effect until Achaogen ceases
development and commercialization of Plazomicin (“Term”).  

 

9.2Termination At Will.  Achaogen may terminate this Agreement in its entirety,
for any reason, by providing at least sixty (60) days prior written notice to
Microgenics.  

 

9.3Termination for Cause.This Agreement may be terminated in its entirety by
written notice by either Party at any time:

 

9.3.1For material breach by the other Party, which breach remains uncured for
ninety (90) days from the date written notice of such breach is given to the
breaching Party, or, if such breach is not susceptible of cure within such
ninety (90) day period and the breaching Party uses diligent good faith efforts
to cure such breach, for one hundred eighty (180) days after written notice to
the breaching Party if such breach remains uncured; or

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9.3.2Upon the filing or institution of bankruptcy, reorganization, liquidation
or receivership proceedings, or upon an assignment of a substantial portion of
the assets for the benefit of creditors by the other Party, or in the event a
receiver or custodian is appointed for such Party’s business, or if a
substantial portion of such Party’s business is subject to attachment or similar
process; provided, however, that in the case of any involuntary bankruptcy
proceeding such right to terminate shall only become effective if the proceeding
is not dismissed within sixty (60) days after the filing thereof.

 

9.4Effect of Termination.  Upon termination of this Agreement pursuant to
Sections 9.1 (Term), Section 9.2 (Termination At Will) or 9.3 (Termination for
Cause):

 

9.4.1All rights and licenses granted under Section 6.1 (License by Achaogen) of
this Agreement shall terminate and all rights to the Achaogen Patents and
Achaogen Know-How shall revert to Achaogen.

 

9.4.2All rights and licenses granted under Section 6.2 (License by Microgenics)
of this Agreement shall terminate and, subject to Section 9.4.4, all rights to
the Immunoassay Technologies and Microgenics Know-How shall revert to
Microgenics.  

 

9.4.3Microgenics shall promptly return or destroy (as directed by Achaogen) to
Achaogen all Achaogen Know-How and Achaogen Materials provided to Microgenics
hereunder, and, subject to Section 9.4.4, Achaogen shall promptly return to
Microgenics all Microgenics Know-How provided to Achaogen hereunder;

 

9.4.4Solely in the case of termination of this Agreement by Achaogen under
Section 9.3 (Termination for Cause):

 

9.4.4.1Microgenics hereby grants Achaogen a Transfer License; provided, that,
Achaogen covenants not to use the Transfer License beyond the scope set forth in
Section 1.33. In the event that Microgenics reasonably believes that Achaogen
has breached the foregoing covenant, Microgenics shall provide written notice
thereof, including reasonable supporting evidence, and, in the event that
Achaogen agrees with such written notice and does not indicate to Microgenics
that it will conform its activities to the scope of the Transfer License within
[***] ([***]) business days after receiving the written notice, then the
Transfer License shall be void as of the end of [***] period described in this
sentence. If Achaogen indicates that it will so conform its activities, then the
Transfer License shall remain in full force and effect.  In the event that
Achaogen disagrees with such written notice and advises Microgenics of such
disagreement, the Parties shall submit this matter to the Dispute resolution
process in 13.8.  For purposes of resolving any disputes regarding the Transfer
License, the Parties agree to complete the Dispute resolution process in 13.8
within [***] from the date of Microgenics’ first written notice of the breach of
the covenant found in the proviso to the first sentence of this Section
9.4.4.1(i).  If after concluding the Dispute resolution process in 13.8 it is
determined that the covenant found in the proviso was breached, then the
Transfer License shall terminate immediately.   In the event that the Transfer
License is granted, Achaogen shall owe no payments to Microgenics for the first
[***] ([***]) months that any Assay commercialized under the Transfer License is
commercialized and shall pay a [***] percent ([***]%) royalty on its net sales
(i.e., gross sales less all deductions, reductions and offsets reasonably taken
in accordance with generally accepted accounting principles in the United
States) of Assays commercialized under the Transfer License following the end of
such [***] ([***]) month

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period.  

 

9.4.4.2Microgenics shall (a) make its personnel available for a reasonable
period of time (not to exceed [***] ([***]) months) to effect a successful
technology transfer with respect to the manufacture and commercialization of the
Assay, (b) provide Achaogen with copies of the physical embodiment of all
processes, protocols, procedures, methods, tests and other intellectual property
rights licensed to Achaogen under the Transfer License, as applicable, related
to the Assay (including the manufacture thereof), (c) supply [***] (including
[***]) reasonably required to perform [***] as may be required by the applicable
Regulatory Authorities, and upon request by Achaogen, [***], provide Achaogen
(and/or its designee) with [***] related to the Assay, and (d) promptly assist
Achaogen (and/or its designee) in obtaining all necessary Regulatory Approvals
and/or modifying and/or transferring existing Regulatory Approvals to enable
Achaogen (and/or its designee) to develop, make, have made, use, market,
distribute, import, sell and offer for sale the Assay ([***]).

 

9.4.4.3If, at the date of the actual termination of this Agreement, Microgenics
is commercializing the Assay, such termination shall be suspended, and
Microgenics shall continue to supply the Assay to the market, until [***];
provided that (i) such period shall not extend beyond an additional [***]
([***]) months from the date of the actual termination of this Agreement, (ii)
Achaogen, itself or through or in conjunction with a Third Party, may
commercialize another assay for use in conjunction with Plazomicin (i.e.,
Microgenics shall lose its commercial exclusivity), and (iii) Section 4.2.3
shall be of no force or effect during any such suspended termination.

 

9.4.5If this Agreement is terminated during the Term at any time by Achaogen
under Section 9.2 (Termination At Will) or by Microgenics under Section 9.3
(Termination for Cause), the following terms shall apply:

9.4.5.1Solely to the extent the expiration or termination of this Agreement
occurs prior to the payment of all development payments described in Section
7.1, Achaogen shall pay to Microgenics an amount equal to the first applicable
unpaid development payment as described in Section 7.1 (Development Payments)
for the period in which the Agreement is terminated or expires (for illustrative
purposes only, if Achaogen provides notice of termination under Section 9.1
(Term) prior to the completion of the Phase 3: [***], then Achaogen shall pay an
amount equal to USD $[***] to Microgenics pursuant to the terms of Section 7.2
(Invoices; Mechanism of Payment)); provided, that, notwithstanding the
foregoing, no payment shall be due under this Section 9.4.5.1 in the event that
this Agreement is terminated by Achaogen under Section 9.2 (Termination At Will)
at any time in connection with the failure to obtain, or maintain, Regulatory
Approval for Plazomicin; and

 

9.4.5.2for a period of two (2) years after the expiration or termination date of
this Agreement pursuant to Section 9.4.5, in the event Achaogen decides to
continue to develop and commercialize Plazomicin, Achaogen shall provide written
notice thereof to Microgenics and, upon Achaogen’s receipt of a written proposal
from Microgenics, the Parties shall use good faith efforts to negotiate a
definitive agreement for the continued development, manufacture, supply and sale
of the Assay by Microgenics on commercially reasonable terms; provided, however,
that nothing in this Section 9.4.5.2 shall (a) obligate Achaogen to enter into
any new agreement with Microgenics with respect to the development, manufacture,
supply or sale of the Assay or (b) prohibit Achaogen from negotiating or
entering into an agreement with any Third Party with respect to the development,
manufacture, supply or sale of any assay.

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9.4.6The termination, expiration or non-renewal of this Agreement shall not
relieve either Party from any obligation that accrues pursuant to this Agreement
before the effective date of the termination or expiration nor shall it release
the Parties from any obligation that may have been incurred as a result of
operations conducted under this Agreement.

 

9.5Survival. Termination of this Agreement for whatever reason in accordance
with the provisions hereof or expiration of this Agreement shall not affect the
accrued rights of the Parties, and shall not limit remedies that may be
otherwise available in law or equity. Article 1 (Definitions), Section 4.1
(Manufacture), 8 (Intellectual Property Rights; Ownership) (except for Section
8.8 (Trademarks) (unless Achaogen intends to commercialize the Assay upon
termination)), 11 (Indemnification), 12 (Confidentiality), and 13
(Miscellaneous) and Section 3.6 (Right of Reference) (but only in the event that
Achaogen intends to commercialize the Assay upon termination), 9.4 (Effect of
Termination) and 9.5 (Survival) shall survive expiration or termination of this
Agreement for any reason. All other rights and obligations will terminate upon
expiration of this Agreement.

 

10Representations and Warranties

 

10.1Representations and Warranties of Each Party.  Each of Achaogen and
Microgenics hereby represents, warrants and covenants to the other Party hereto
as follows:

 

10.1.1it is a corporation or other entity duly organized and validly existing
under the laws of the state or other jurisdiction of incorporation or formation;

 

10.1.2the execution, delivery, and performance of this Agreement by such Party
has been duly authorized by all requisite corporate action and does not require
any shareholder action or approval;

 

10.1.3no consent, approval, order or authorization of, or registration,
declaration or filing with, or exemption by, any Third Party or any governmental
entity is required by or with respect to such Party in connection with the
execution, delivery and performance of this Agreement;

 

10.1.4this Agreement constitutes a valid and legally binding obligation of such
Party, enforceable against such Party in accordance with its respective terms,
except as may be limited by (a) applicable bankruptcy, insolvency,
reorganization or other laws of general application relating to or affecting the
enforcement of creditors’ rights generally and (b) the effect of rules of law
governing the availability of equitable remedies;

 

10.1.5the execution, delivery and performance of this Agreement do not and will
not conflict with, or result in any violation of, or default (with or without
notice or lapse of time, or both) under, or give rise to a right of termination,
cancellation or acceleration of any obligation that would result in the creation
of any encumbrance upon any of the assets owned by such Party under, any
material provision of Applicable Law, of such Party’s organizational documents
or of any agreement, judgment, injunction, order, decree, or other instrument
binding on such Party or any assets owned by such Party; and

 

10.1.6it shall comply with all material Applicable Laws relating to its
activities under this Agreement.

 

10.2Representations and Warranties of Microgenics.  In addition to the
representations and

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warranties made by Microgenics under Section 10.1 (Representations and
Warranties of Each Party) above, Microgenics further represents and warrants to
Achaogen that:

 

10.2.1it has the capacity and resources (including [***]) to (i) develop,
manufacture and supply the Assay in and for the Territory, and (ii)
commercialize the Assay in the Primary Countries;

10.2.2and further covenants that, the Assay shall be developed, manufactured,
commercialized, and shall function, in accordance with applicable GMP,
Specifications and Applicable Laws;

 

10.2.3it has the capacity and resources to develop (including [***]),
manufacture and commercialize the Assay in accordance with this Agreement,
including in accordance with the Project Plan;

 

10.2.4to the best of its knowledge, the development, manufacture, use and sale
of the Assay will not infringe any issued Patents in the Territory owned or
controlled by any Third Party; and

 

10.2.5it owns or controls all rights to the Microgenics Cell Lines, Microgenics
[***] Antibodies, and Immunoassay Technologies.

 

10.3Representations and Warranties by Achaogen.  In addition to the
representations and warranties made by Achaogen under Section 10.1
(Representations and Warranties of Each Party) above, Achaogen further
represents and warrants to Microgenics that:  

 

10.3.1it owns, controls or has the right and ability to grant Microgenics the
licenses under its (and its Affiliates) rights in the Achaogen Patents (as
listed in Exhibit B hereto) related to the use of Plazomicin, pursuant to this
Agreement; and

 

10.3.2it owns, controls or has the right and ability to provide to Microgenics
the Achaogen Materials for development, manufacture, marketing, and sale of the
Assay pursuant to this Agreement.

 

10.4Debarment and Exclusion.  Achaogen and Microgenics represent and warrant
that neither it, nor any of its employees or agents working on the subject
matter of this Agreement, has ever been, is currently, or is the subject of a
proceeding that could lead to it becoming, as applicable, a Debarred Entity or
Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted
Entity or Convicted Individual, nor are they listed on the FDA’s
Disqualified/Restricted List for clinical investigators. Each Party further
covenant, represent and warrant that if, during the Term, it, or any of its
employees or agents working on their behalf, becomes or is the subject of a
proceeding that could lead to that Party with respect to the subject matter
hereof, becoming, as applicable, a Debarred Entity or Debarred Individual, an
Excluded Entity or Excluded Individual or a Convicted Entity or Convicted
Individual, or added to FDA’s Disqualified/Restricted List for clinical
investigators, the Party shall immediately notify the other Party. This
provision shall survive termination or expiration of this Agreement. For
purposes of this provision, the following definitions shall apply:

 

10.4.1A “Debarred Individual” is an individual who has been debarred by the FDA
pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity
to a person that has an approved or pending drug product application.

 

10.4.2A “Debarred Entity” is a corporation, partnership or association that has
been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting
or assisting in the submission of

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any abbreviated drug application, or a subsidiary or Affiliate of a Debarred
Entity.

 

10.4.3An “Excluded Individual” or “Excluded Entity” is (a) an individual or
entity, as applicable, who has been excluded, debarred, suspended or is
otherwise ineligible to participate in federal health care programs such as
Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the
U.S. Department of Health and Human Services, or (b) is an individual or entity,
as applicable, who has been excluded, debarred, suspended or is otherwise
ineligible to participate in federal procurement and non-procurement programs,
including those produced by the U.S. General Services Administration (GSA).

 

10.4.4A “Convicted Individual” or “Convicted Entity” is an individual or entity,
as applicable, who has been convicted of a criminal offense that falls within
the ambit of 42 U.S.C. §1320a – 7(a), but has not yet been excluded, debarred,
suspended or otherwise declared ineligible.

 

10.4.5“FDA’s Disqualified/Restricted List” is the list of clinical investigators
restricted from receiving investigational drugs, biologics or devices if the
United State Food and Drug Administration (“FDA”) has determined that the
investigators have repeatedly or deliberately failed to comply with regulatory
requirements for studies or have submitted false information to the study
sponsor.

 

10.5Disclaimer. EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED
IN THIS AGREEMENT, NEITHER MICROGENICS NOR ACHAOGEN MAKES, AND EACH HEREBY
EXPRESSLY DISCLAIMS, ANY REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR
IMPLIED, WHETHER IN FACT OR IN LAW, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.

 

10.6No Representations Regarding Approval or Commercial Success. Neither Party
makes any representations or warranties as to: (a) whether Plazomicin or the
Assay will be approved for commercial sale by the applicable Regulatory
Authorities; or (b) the commercial potential or success of Plazomicin or the
Assay.

 

11Indemnification

 

11.1Indemnification by Achaogen.  Achaogen shall indemnify, defend and hold
harmless Microgenics and its Affiliates and each of its and their respective
employees, officers, directors and agents (each a “Microgenics Indemnified
Party”) from and against any and all liabilities, damages, penalties, expenses
and/or losses (including reasonable legal expenses and attorneys’ fees)
(collectively, “Losses”), resulting from any Third Party suits, claims, actions
or demands (collectively, “Third Party Claims”), to the extent arising out of or
relating to: (a) the breach by Achaogen of any representation, warranty or
covenant contained in this Agreement; (b) the willful misconduct or negligent
acts or omissions of Achaogen, its Affiliates or any of their respective
employees, officers, directors or agents; (c) the manufacture, promotion,
distribution, use, testing, marketing or sale of pharmaceutical products
containing Plazomicin by Achaogen or its Affiliates; or (d) claims of
infringement of Third Party Patents based upon the manufacture, use or sale of
Plazomicin; except, in each case, to the extent such Losses result from clauses
(a), (b), (c) or (d) of Section 11.2 (Indemnification by Microgenics).    

 

11.2Indemnification by Microgenics.   Microgenics shall indemnify, defend and
hold harmless Achaogen and its Affiliates and each of its and their respective
employees, officers, directors and agents (each a “Achaogen Indemnified Party”)
from and against any and all Losses, resulting from any Third Party

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Claims, to the extent arising out of or relating to: (a) the breach by
Microgenics of any representation, warranty or covenant contained in this
Agreement; (b) the willful misconduct or negligent acts of Microgenics, its
Affiliates or any of their respective employees, officers, directors, or agents;
(c) the manufacture, promotion, distribution, use, testing, marketing or sale of
the Assay; or (d) claims of infringement of Third Party Patents based upon the
manufacture, use or sale of the Assay; except, in each case, to the extent such
Losses result from clauses (a), (b) (c) or (d) of Section 11.1 (Indemnification
by Achaogen).  

 

11.3Conditions to Indemnification    The obligations of the indemnified Party
under Sections 11.1 (Indemnification by Achaogen) and 11.2 (Indemnification by
Microgenics) are conditioned upon the delivery of written notice to the
indemnifying Party of any potential liability promptly after the indemnified
Party become aware of such potential liability; provided, however, that the
failure to give such notice promptly shall not impair a Party’s right to
indemnification under this Section 11.3 (Conditions to Indemnification) unless
the delay in providing such notice has a material adverse effect on the ability
of the indemnifying Party to defend against such liability. The indemnifying
Party shall have the right to assume the defense of any suit or claim relating
to the liability if it has assumed responsibility for the suit or claim in
writing; however, if in the reasonable judgment of the indemnified Party, such
suit or claim involves an issue or matter which could have a material adverse
effect on the business operation or assets of the indemnified Party, the
indemnified Party may waive its rights to indemnity under this Agreement and
control the defense or settlement thereof, but in no event shall any such waiver
be construed as a waiver of any rights such indemnified Party may have against
any Third Party at law or in equity. If the indemnifying Party defends the suit
or claim, the indemnified Party shall cooperate with the indemnifying Party in
such defense and the indemnified Party or Parties may participate in (but not
control) the defense thereof at its sole cost and expense.

 

11.4Settlements. Neither of the Parties may settle a claim or action related to
a Third Party Claim without the consent of the other Party, if such settlement
would impose any monetary obligation on the other Party, or would require the
other Party to submit to an injunction or otherwise limit the other Party’s
rights under this Agreement. Any payments made by a Party to settle any such
claim or action shall be at its own costs and expense, except in the event such
payment was made with the prior written consent of an indemnifying Party, in
which case such payment shall be subject to the obligations of the Parties as
set forth in Sections 11.1 (Indemnification by Achaogen), 11.2 (Indemnification
by Microgenics), and 11.3 (Conditions to Indemnification).

 

11.5Limitation of Liability.  except with respect to damages that arise due to a
Party’s breach of confidentiality (article 12) or indemnification obligations
(article 11), in no event will either Party be liable to the other for
consequential, indirect, special, exemplary or punitive damages for any cause of
action, whether in contract, tort or otherwise, including lost revenues, profits
or business opportunities arising out of or in connection with this Agreement,
whether or not the other Party was or should have been aware of the possibility
of these damages.  except with respect to damages that arise due to a Party’s
breach of confidentiality (article 12) or indemnification obligations (article
11), the liability of either Party under this Agreement (whether by reason of
breach of contract, tort, or otherwise) with respect to a given claim shall not
exceed an amount equal to [***].

 

11.6Insurance.  Each Party shall maintain, through self-insurance or
commercially-placed insurance, adequate commercial general liability and
products liability insurance, including contractual liability coverage,
necessary to satisfy its obligations hereunder and consistent with
pharmaceutical and

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diagnostic industry practices.  

 

12Confidentiality

 

12.1Nondisclosure.  During the Term, and for a period of [***] ([***]) years
thereafter, all Confidential Information disclosed to a Party hereto or its
Affiliates (the “Receiving Party”) by the other Party or its Affiliates (the
“Disclosing Party”) shall be deemed confidential and shall be treated as such by
the Receiving Party (meaning that the Receiving Party shall take the same steps
to protect such information as it does to protect its own confidential
information, which in any event shall be no less than the reasonable protective
measures for the industry) and shall only be used for the purposes of this
Agreement. Notwithstanding the foregoing, Confidential Information shall not
include information that is:

 

 

(a)

known by the Receiving Party at the time of its receipt and not through a prior
disclosure by the Disclosing Party;  

 

 

(b)

at the time of disclosure or thereafter, becomes published or otherwise part of
the public domain through no breach of this Agreement by the Receiving Party;  

 

 

(c)

subsequently disclosed to the Receiving Party by a Third Party having the right
to make such a disclosure;  or

 

 

(d)

developed by the Receiving Party, as evidenced by its records, independently of
information received by it from the Disclosing Party hereunder.

 

12.2Permitted Disclosure.  Information provided under this Agreement may be
disclosed to employees, agents or consultants of the Receiving Party, but only
to the extent required to accomplish the purposes of this Agreement and only
after the Receiving Party obtains the prior agreement of its employees, agents
and consultants to whom disclosure is to be made to hold in confidence and not
to make use of such information for any purpose other than that permitted by
this Agreement. In addition to the foregoing exceptions, either Party may
disclose Confidential Information to the extent it is required to be disclosed
under Applicable Law, or in connection with any application by the Receiving
Party for any Regulatory Approvals; provided, however, that the Receiving Party
shall furnish the Disclosing Party with as much prior written notice of such
disclosure requirement as reasonably practicable, so as to permit the Disclosing
Party, in its sole discretion, and at its sole expense, to take appropriate
action, including seeking a protective order, in order to prevent the Disclosing
Party’s Confidential Information from passing into the public domain or becoming
generally available to the public.

 

12.3Publicity.  The Parties agree to make a joint public release of the having
entered into this Agreement upon the successful completion of Phase I as
described in Exhibit F. The public release must however not contain any
Confidential Information of any kind such as scientific, commercial or financial
which both Parties have not agreed to include in writing. No public announcement
concerning the existence, terms or subject matter of this Agreement shall be
made, either directly or indirectly, by any Party, without first obtaining the
prior written approval of the other Party and agreement upon the nature and text
of such public announcement which such agreement and approval shall not be
unreasonably withheld. Notwithstanding the foregoing, if, in the opinion of
legal counsel for the Party desiring to make such public announcement, such
disclosure is required under Applicable Law, subject to Section 12.2 (Permitted
Disclosure) above, the Party required to make such public announcement shall
inform the other Parties of the proposed announcement or disclosure in
reasonably sufficient time prior to public release, which shall be not

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less than [***] ([***]) business days (or such shorter period as may be required
under Applicable Law) prior to release of such proposed public announcement, and
shall provide the other Parties with a written copy thereof in order to allow
such other Parties to comment upon such public announcement. The Receiving Party
shall reasonably cooperate with the Disclosing Party (at the Disclosing Party’s
expense) with respect to all disclosures regarding this Agreement required under
Applicable Law, including requests for confidential treatment of proprietary
information of the Disclosing Party included in any such disclosure.  

 

12.4Applicable Law. Nothing in this Agreement shall be construed as preventing
or in any way inhibiting any Party from complying with Applicable Law governing
activities and obligations undertaken pursuant to this Agreement, in any manner
which it reasonably deems appropriate, including, for example, by disclosing to
Regulatory Authorities confidential or other information received from the other
Parties, subject to Sections 12.2 (Permitted Disclosure) and 12.3 (Publicity).

 

12.5Non-Use of Names. Except as otherwise provided in this Agreement, neither
Party (or its Affiliates) shall use, either directly or indirectly, the
Trademarks of the other Party (or their Affiliates), or the names of any of
their officers, employees or board members in any publicity, marketing
advertising or other documents (or other disclosures) unless (a) such use is
consistent with, and permitted under, the Project Plan or (b) a copy or
transcript of the proposed disclosure is submitted to and approved in advance in
writing by the other Party (each in its sole discretion), except in the case in
which a governmental authority requires the use of the Trademark by a Party in
the sale or distribution of the Assay or Plazomicin. Each Party will use good
faith efforts to review and approve any proposed disclosure within [***] ([***])
business days of its receipt from the other Party of a copy or transcript of the
proposed disclosure. If a Party approves the other Party’s usage of its
Trademarks (or its Affiliates), or the names of any of their officers, employees
or board members in accordance with this Section 12.5 (Non-Use of Names), the
other Party shall comply with any usage guidelines or requirements imposed by
the approving Party.

 

12.6Publications. Publication in a journal, paper, magazine or any other such
similar disclosure relating to the development, manufacture or commercialization
of the Assay will not take place without the prior written agreement of both
Achaogen and Microgenics, which shall not be unreasonably withheld. Any draft
article intended to be submitted for publication by Microgenics or Achaogen (or
a clinical trial site utilized by Achaogen) hereto shall first be sent to the
other Party in order to allow such Party to preserve its intellectual property
rights by delaying such publication (but not for more than [***] ([***]) days)
and/or removing its Confidential Information. Achaogen’s and/or Microgenics’
contribution shall be acknowledged in any publication by co-authorship or
acknowledgment, whichever is appropriate. Republication of any article, in whole
or in part, which has previously been approved by the Parties shall not require
subsequent approval, provided that the content is substantially unchanged. These
restrictions are not applicable to Plazomicin; provided, however, that, for
clarity, Microgenics shall have no right to publish with respect to
Plazomicin.  

 

12.7Prior CDAs.  This Agreement supersedes that certain Confidential Disclosure
Agreement between the Parties dated [***]; provided, however, that all
Confidential Information disclosed or received by the Parties thereunder will be
deemed Confidential Information hereunder and will be subject to the terms and
conditions of this Agreement. For clarity, this Agreement does not supersede the
Antibody Development Agreement.  

 

13Miscellaneous

 

13.1Force Majeure.  Neither Party shall be liable to the other for delay or
failure in the

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performance of the obligations on its part contained in this Agreement if and to
the extent that such failure or delay is due to government action, war,
terrorism, fire, explosion, flood, strike, lockout, embargo, shortage of
materials or utilities, vendor failure to supply, act of God, or any other cause
beyond the control and without the fault or negligence of the defaulting Party
(a “Force Majeure Event”), provided that the Party claiming Force Majeure Event
has exerted all Commercially Reasonable Efforts to avoid or remedy such force
majeure. Such excuse shall continue as long as the condition preventing the
performance continues. Upon cessation of such Force Majeure Event, the affected
Party shall promptly resume performance hereunder. Each Party agrees to give the
other Party prompt written notice of the occurrence of any such Force Majeure
Event, the nature thereof, and the extent to which the affected Party will be
unable to perform its obligations hereunder. Each Party further agrees to use
all Commercially Reasonable Efforts to correct the Force Majeure Event [***] and
to give the other Party prompt written notice when it is again fully able to
perform its obligations hereunder.

 

13.2Assignment.  Neither Party may assign this Agreement to a Third Party unless
both Parties have agreed to such assignment in a writing signed by an authorized
representative of each Party hereto; provided, however, that upon providing
written notice, (i) either Party may, without the other Party’s consent, assign
this Agreement to an Affiliate or to any Third Party entity that acquires all or
substantially all of its assets to which this Agreement relates and (ii)
Achaogen may, without Microgenics’ consent, assign this Agreement (in whole or
in part) to a Third Party licensee of Achaogen’s rights with respect to
Plazomicin. This Agreement shall be binding upon and inure to the benefit of the
successors and permitted assigns of the Parties. Any assignment not in
accordance with this Section 13.2 (Assignment) shall be void.  

 

13.3No Waiver.  The failure of either Party to require performance by the other
Party of any of that other Party’s obligations hereunder shall in no manner
affect the right of such Party to enforce the same at a later time. No waiver by
any Party hereto of any condition, or the breach of any provision, term,
representation or warranty contained in this Agreement, whether by conduct or
otherwise, in any one or more instances, shall be deemed to be or construed as a
further or continuing waiver of any such condition or breach, or of any other
condition or of the breach of any other provision, term, representation or
warranty hereof.

 

13.4Severability.  If a court or other tribunal of competent jurisdiction should
hold any term or provision of this Agreement to be excessive, or invalid, void
or unenforceable, the offending term or provision shall be deleted, and, if
possible, replaced by a term or provision which, so far as practicable, achieves
the legitimate aims of the Parties.  In the event that such provisions cannot be
agreed upon, the invalidity, illegality or unenforceability of one or more
provision of this Agreement shall not affect the validity of this Agreement as a
whole.  

 

13.5Relationship Between the Parties.  Both Parties are independent contractors
under this Agreement. Nothing herein contained shall be deemed to create an
employment, agency, joint venture or partnership relationship between the
Parties hereto or any of their agents or employees, or any other legal
arrangement that would impose liability upon one Party for the act or failure to
act of the other Party. Neither Party shall have any express or implied power to
enter into any contracts or commitments or to incur any liabilities in the name
of, or on behalf of, the other Party, or to bind the other Party in any respect
whatsoever.

 

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13.6Correspondence and Notices.  Correspondence, reports, documentation and any
other communication in writing between the Parties in the course of
implementation of this Agreement shall be in writing and sent by internationally
recognized overnight delivery service that maintains records of delivery, or by
facsimile confirmed by prepaid registered or certified air mail letter, and
shall be deemed to have been properly served to the addressee upon the date
delivered by hand or transmitted by facsimile (with transmission confirmed) or
on the second business day (at the place of delivery) after deposit with an
internationally recognized overnight delivery service. The proper address for
communication and for all payments shall be:

 

To Microgenics:With a copy to:

 

Microgenics CorporationThermo Fisher Scientific

Attn: VP & General ManagerAttn: SDG General Counsel

46500 Kato Road81 Wyman Street

Fremont, CA 94538Waltham, MA 02451

Fax: Fax: (781) 622-1283

 

 

To Achaogen:With a copy to:

 

 

Achaogen Inc.  

 

7000 Shoreline Court, #371

 

South San Francisco, CA 94080

 

Fax:

 

 

13.7Choice of Law.  This Agreement is subject to and governed by the laws of the
State of Delaware, U.S.A. (without regard to conflict of law principles).  

 

13.8Dispute Resolution.  

 

13.8.1Executive Resolution. In the event of a dispute with respect to (a) the
validity, interpretation or construction of this Agreement, (b) compliance with
this Agreement or (c) a breach of this Agreement (a “Dispute”), a Party may
provide the other Party with written notice of the Dispute, and the Parties
agree to exercise reasonable efforts to resolve the Dispute in good faith by
promptly engaging in discussions with duly authorized representatives of the
Parties. If the Dispute cannot be resolved by such authorized representatives of
the Parties within [***] ([***]) business days, the authorized representatives
shall refer the Dispute to a meeting between a senior executive representing
each Party (currently the [***] for Achaogen, and the [***] for Microgenics),
which such senior executives shall participate in at least one in person meeting
as soon as practicable, but in no event later than [***] ([***]) days after the
date of the relevant referral. If the senior executives for Achaogen and
Microgenics cannot resolve such Dispute in a mutually acceptable manner within
[***] ([***]) business days after such meeting, then the Dispute shall be
resolved exclusively by final and binding arbitration in accordance with Section
13.8.2.  

 

13.8.2Arbitration. Arbitration will be conducted exclusively in the State of
Delaware by arbitration administered by the American Arbitration Association
(“AAA”) under its Commercial Arbitration Rules and Supplementary Procedures for
Large Complex Disputes, and judgment on the award rendered by the arbitrator(s)
may be entered in any court having jurisdiction thereof. [***]. Notwithstanding
anything in this Agreement to the contrary, each Party shall have the right, at
its election, to seek injunctive or other equitable relief in any court of
competent jurisdiction to enforce or obtain compliance with any provision of

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this Agreement without first submitting such matter to arbitration. All rights
and remedies hereunder shall be cumulative, may be exercised singularly or
concurrently and, unless otherwise stated herein, shall not be deemed
exclusive.  

 

13.9Entire Agreement; Amendment.  Except as otherwise set forth in Section 12.7,
this Agreement and the Antibody Development Agreement, including the Exhibits
and Schedules hereto and thereto and all the covenants, promises, agreements,
warranties, representations, conditions and understandings contained herein and
therein sets forth the complete, final and exclusive agreement between the
Parties and supersedes and terminates all prior and contemporaneous agreements
and understandings between the Parties, whether oral or in writing. There are no
covenants, promises, agreements, warranties, representations, conditions or
understandings, either oral or written, between the Parties other than as are
set forth in this Agreement and the Antibody Development Agreement. No
subsequent alteration, amendment, change, waiver or addition to this Agreement
shall be binding upon the Parties unless reduced to writing and signed by an
authorized officer of each Party. No understanding, agreement, representation or
promise, not explicitly set forth herein, or in the Antibody Development
Agreement, has been relied on by either Party in deciding to execute this
Agreement. Notwithstanding anything to the contrary contained herein or in the
Antibody Development Agreement, nothing in the Antibody Development Agreement
shall be deemed to modify or diminish the representations, warranties, covenants
and obligations of the Parties under this Agreement and in the event of any
conflict between the terms and conditions of this Agreement and the terms and
conditions of the Antibody Development Agreement, this Agreement shall govern
except with respect to Section 4.2.7.3 of this Agreement which shall be subject
to the Antibody Development Agreement.  

 

13.10Headings.  The headings and captions used in this Agreement are solely for
the convenience of reference and shall not affect its interpretation.

 

13.11Counterpart.  This Agreement may be executed in one or more counterparts,
each of which shall be an original, and all of which shall constitute together
the same document. Each Party acknowledges that an original signature or a copy
thereof transmitted by facsimile (or .pdf file) shall constitute an original
signature for purposes of this Agreement.

 

13.12Further Actions.   Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement
including any filings with any antitrust agency which may be required.

 

13.13Affiliates. Both Parties shall have the right, in their sole discretion, to
perform some or all of its obligations and exercise some or all of its rights
under this Agreement through its Affiliates.  

 

13.14Joint Negotiation. This Agreement is the joint product of Microgenics and
Achaogen, and each provision hereof has been subject to the mutual consultation,
negotiation and agreement of the Parties and their respective legal counsel and
advisers and any rule of construction that a document shall be interpreted or
construed against the drafting Party shall not be applicable.

 

13.15Construction.  Except where the context otherwise requires, wherever used,
the singular shall include the plural, the plural the singular, the use of any
gender shall be applicable to all genders and the word “or” is used in the
inclusive sense (and/or). All references to a “business day” or “business days”
in this Agreement means any day other than a day which is a Saturday, a Sunday
or any day banks are authorized or required to be closed in the United States.
The words “include”, “includes” and “including” shall be deemed to be followed
by the phrase “without limitation”. The word “will” shall be construed to have
the same

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meaning and effect as the word “shall.” The words “herein”, “hereof” and
“hereunder”, and words of similar import, shall be construed to refer to this
Agreement in its entirety and not to any particular provision hereof. All
currency herein shall refer to United States dollars, unless specifically
provided otherwise. All exhibits to this Agreement are hereby made a part of
this Agreement.

 

13.16Use of Third Parties. All obligations under this Agreement shall be
performed by the Party designated to perform such obligations under this
Agreement and such obligations may not be performed by a Third Party on such
Party’s behalf, unless (a) the other Party has consented in writing which shall
not be unreasonably be withheld or delayed, (b) the Party engaging such Third
Party performs appropriate qualification and oversight of such Third Party in
accordance with the Applicable Law, including applicable GMP, GCP, and GLP
requirements, and (c) the Party engaging such Third Party ensures that such
Third Party complies with the terms and conditions of this Agreement, and
provided that such performance of activities by a Third Party is consistent with
the rights and obligations of the Parties under this Agreement. Notwithstanding
any such consent, each Party shall remain at all times fully liable for its
respective responsibilities under this Agreement. Each Party hereby expressly
waives any requirement that the other Party exhaust any right, power or remedy,
or proceed against such subcontractor for an obligation or performance
hereunder, prior to proceeding directly against the Party engaging such
subcontractor.  

 

 

[Signature Page to Follow]

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IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly
executed this Agreement to be effective as of the Effective Date.

 

 

 

ACHAOGEN INC.MICROGENICS CORPORATION

 

By: /s/ Blake Wise

By: /s/ Marc Tremblay

Name: Blake Wise

Name: Marc Tremblay

Title: COO

Title: President, Clinical Diagnostics

Date: 4/26/16

Date: 4/26/2016

 

 

 

 

Signature Page to Collaborative Development and Commercialization Agreement

DB2/ 26356633.19

 

 

 

 

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Exhibit A

Achaogen Materials

 

 

 

Achaogen Materials

Estimated Amount

Estimated Development Phase Required

[***]

 

 

(1)

[***]

 

 

 

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Exhibit B

Achaogen Patents

[***]

 

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Exhibit C

Microgenics’ Cell Lines

 

[***]

Clone #

Clone ID

[***]

 

 

[***]

Clone #

Clone ID

[***]

 

[***]

Clone #

Clone ID

[***]

 

 

[***]

Rabbit

Identity

Immunogen

[***]

 

[***]

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Exhibit D

Plazomicin Chemical Structure

 

 

[g2017050820081368717.jpg]

 

 

 

 

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Exhibit E

Primary Countries

 

Achaogen Primary Country List

Country

Country

[***]

 

 

 

 

 

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Exhibit F

Project Plan Timeline and Deliverables

 

 

Plazomicin TDM Immunoassay Development Project Plan Timeline and Deliverables

 

Deliverables

Start

End

Duration (M)

Phase 0

[***]

[***]

[***]

[***]

[***]

[***]

Phase 1

[***] 

[***]

[***]

[***]

•[***]

•[***]

Phase 2

[***]

[***]

[***]

[***]

[***]

[***]

Phase 3

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

Phase 4

[***]

[***]

[***]

[***]

Milestone 1: [***]

[***]

[***]

[***]

[***]

Milestone 2: [***]

[***]

[***]

[***]

[***]

Milestone 3: [***]

[***]

[***]

[***]

Milestone 3A: [***]

[***]

[***]

[***]

[***]

Milestone 3B: [***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

Phase 5

[***]

[***]

[***]

[***]

Milestone 1: [***]

[***]

[***]

[***]

[***]

Milestone 2: [***]

[***]

[***]

[***]

[***]

 

 

 

 

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Exhibit G

Specifications

 

[***]

 

Performance Attributes

Desired Value(s)

Acceptable Value(s)

[***]

 

 

 

1

[***]

 

 

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Exhibit H - BARDA Requirements

 

1.0

Additional Terms and Conditions for this Agreement as a Federal Subcontract

 

1.1

Purpose. This Agreement is a subcontract under the following Achaogen Government
Contract(s):

 

•

Contract No. HHSO100201000046C (BARDA 0046C Contract) between Achaogen, Inc. and
Department of Health and Human Services, Biomedical Advanced Research and
Development Authority;

The purpose of this Section 1.0 is to incorporate by reference certain
government (“ Government”) contract clauses (flow downs) associated with the
Achaogen Government Contract(s) specified above, that Achaogen, as a prime
contractor, must include, and by which Microgenics, as a subcontractor, must
abide.

 

1.2

Incorporated Government Contract Clauses

 

(a)

For BARDA Contract. This Agreement incorporates by reference Appendix A,
“Government Provisions for Commercial Item  Subcontracts  Under Contract
No.  HHSO100201000046C  (BARDA 0046C Contract).”  Microgenics agrees to abide by
all of the provisions listed in Appendix A hereto as a condition of performance
of services pursuant to any duly-executed Exhibit under this Agreement.

 

1.3

Changes to Government Contracts Provisions

Microgenics agrees that upon the request of Achaogen it will negotiate in good
faith with Achaogen amendments to this Agreement to incorporate additional
provisions herein or to change provisions hereof, as Achaogen may reasonably
deem necessary in order to comply with the provisions of the applicable Achaogen
Government Contract or with the provisions of amendment(s) to such Achaogen
Government Contract.  If any such amendment to this Agreement causes [***], an
equitable adjustment shall be made pursuant to the “Changes” clause of this
Agreement.

 

1.4

RESERVED [Not applicable]  

 

1.5

Government Right to Inspection of Research and Development (Reference: FAR
52.246-9)

 

(a)

Microgenics recognizes that the Government has the right to inspect and
evaluate  work performed or being performed under the Achaogen Government
Contract, including any such work performed or being performed under this
Agreement, to the extent practicable at all reasonable places and times and in a
manner that will not unduly delay the work, including the period of performance,
and in any event before its termination.

 

(b)

If the Government performs any inspection or test on Microgenics’ premises,
Microgenics shall furnish all reasonable facilities and assistance for the safe
and convenient performance of these duties.

 

1.6

Representations and Certifications

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By executing this Agreement, Microgenics represents and certifies that:

 

(a)

neither it, nor any of its Principals (as defined hereinafter), is presently
debarred, suspended, proposed for debarment or otherwise declared ineligible for
participating in any federal or state procurement action by any federal, state,
or local government or agency;

 

(b)

neither it, nor any of its Principals, has within the last three years, been
convicted of, or had a civil judgment rendered against it, for any of the
following:  (i) the commission of fraud or a criminal offense in connection with
obtaining, attempting to obtain, or performing a federal, state or local
government contract or agreement; (ii) a violation of federal or state antitrust
statutes relating to the submission of offers; or (iii) the commission of
embezzlement, theft, forgery, bribery, falsification or destruction of records,
making false statements, tax evasion, or receiving stolen property;

 

(c)

it will comply with all applicable Federal laws and regulations regarding ethics
in public acquisitions and procurement and performance of contracts;

 

(d)

RESERVED

 

(e)

it has not made or solicited and will not make or solicit kickbacks in violation
of FAR 52.203-7 or the Anti-Kickback Act of 1986 (41 USC 51-58);

 

(f)

that (i) no federal appropriated funds have been paid or will be paid to any
person for influencing or attempting to influence an officer or employee of any
agency, a Member of Congress, an officer or employee of Congress, or an employee
of a Member of Congress on his or her behalf in connection with the awarding of
this Agreement;  (ii) if any funds other than federal appropriated funds
(including profit or fee received under a covered federal transaction) have been
paid, or will be paid, to any person for influencing or attempting to influence
an officer or employee of any agency, a Member of Congress, an officer or
employee of Congress, or an employee of a Member of Congress on his or her
behalf in connection with this Agreement, Microgenics  shall complete and
submit, with its offer, OMB standard form LLL, Disclosure of Lobbying
Activities, to the Contracting Officer; and (iii) it will include the language
of this certification in all subcontract awards at any tier and require that all
recipients of subcontract awards in excess of $150,000 shall certify and
disclose accordingly (the definitions and prohibitions contained in the clause
at FAR 52.203-12, Limitation on Payments to Influence Certain Federal
Transactions, included in this Subsection 12.7 (f) and will be included in all
such certifications);

 

(g)

that (i) if Microgenics has participated in a previous contract or subcontract
subject to the Equal Opportunity clause (FAR 52.222-26), Microgenics has filed
all required compliance reports; and (ii) representations indicating submission
of required compliance reports, signed by proposed subcontractors, will be
obtained before subcontract awards; and

 

(h)

that to the best of the Microgenics's knowledge and belief, there are no
relevant facts or circumstances which could give rise to an organizational
conflict of interest, as defined in FAR Subpart 9.5.

Microgenics agrees to provide immediate written notice to Achaogen if, at any
time prior to termination, Microgenics learns that its certification was
erroneous when submitted or has become erroneous by reason of changed
circumstances. For the purpose of paragraphs (a)

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and (b) above, “Principal” means an officer; director, owner; partner; or a
person having primary management or supervisory responsibilities within a
business entity.

 

2.0

Government Interface

 

2.1

Microgenics employees may not communicate with any Government employee,
including Achaogen’s contracting officer (“Contracting Officer”), Contracting
Officer’s representative or their respective support staff, concerning any work
performed pursuant to this Agreement or any associated Exhibit or appendix,
without advance written consent from Achaogen.

 

2.2

Under no circumstances may Microgenics accept Government instruction on behalf
of Achaogen.  Microgenics is not authorized to make offers, commitments, or
otherwise negotiate with the Government on Achaogen’s behalf or its own behalf
in its capacity as a subcontractor to Achaogen. In case of occurrence of any
such events, Microgenics shall:

 

(a)

suggest to the Government representative that Achaogen be involved in all such
discussions, and

 

(b)

immediately report to Achaogen any attempt by Government personnel to provide
such instruction or conduct such negotiations.

 

2.3

If Microgenics communicates with the Government regarding a Project,
Microgenics’s monthly contract management reports shall list all data exchanged
and shall summarize each and every significant discussion with Government
personnel during the reporting period.

3.0

Disputes

 

3.1

Disputes Involving the Prime Contract and/or the Government

 

(a)

Any dispute arising under or related to this Agreement which relates to a matter
for which Achaogen has recourse against the Government under the Achaogen
Government Contract (also hereinafter sometimes referred to as the “Prime
Contract”) shall be resolved as follows unless the Parties otherwise agree in
writing.

 

(b)

Microgenics shall give Achaogen a fully supported written request for equitable
adjustment or claim concerning any such dispute within [***] years after the
basis of the equitable adjustment arises or claim accrues, but in no event later
than [***], or Microgenics shall be barred from any remedy for such claim.

 

(c)

Achaogen shall forward such request for equitable adjustment or claim to the
Contracting Officer on Microgenics’s behalf for final decision, subject to the
limitations and other conditions contained in this provision.  Achaogen shall in
good faith consult with Microgenics concerning the forwarding of such request
for equitable adjustment or claim to the Contracting Officer.

 

(d)

Any final decision of the Contracting Officer under the Prime Contract as it
relates to this Agreement, whether or not it results from a claim under Section
3.1(b) and (c) of this Agreement submitted on Microgenics’s behalf under the
provision stated above, shall be binding upon Microgenics; provided however,
that Achaogen shall notify Microgenics immediately of  any such final decision
of the Contracting Officer and if: (i) Achaogen elects not to appeal such
decision pursuant to the

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“Disputes” clause of the Prime Contract; (ii) Achaogen thereafter receives, no
less than [***] ([***]) days before the expiration of the period of appeal under
the “Disputes” clause of the Prime Contract, a written request by Microgenics to
appeal such decision, and (iii) Achaogen has the right of such appeal under the
Prime Contract, then Achaogen shall file an appeal from the final decision on
Microgenics’s behalf.

 

(e)

If Achaogen appeals such a decision, whether at its election or at
Microgenics’s  request, any decision upon such appeal by the Board of Contract
Appeals, the United States Court of Federal Claims, or any other board or agency
having jurisdiction over the appeal shall be  binding upon Microgenics insofar
as it relates to a claim under this Section 3.1 of this Agreement, provided
however, that if Microgenics timely (i.e., no less than [***] ([***]) days
before the expiration of the relevant period of appeal) requests Achaogen to
bring a further appeal to obtain judicial review of such final decision by a
court of competent jurisdiction, Achaogen shall do so, subject to the terms
below.  A final judgment in any such further appeal, if binding on Achaogen
under the Prime Contract, shall in turn be binding on Microgenics insofar as it
relates to a claim under this Section 3.1 of this Agreement.

 

(f)

In any appeal brought by Achaogen on behalf of Microgenics, or at Microgenics’s
request under the above provisions, [***] shall bear all costs and expenses
incurred by Microgenics in prosecuting such appeal, including but not limited
to, any legal fees or costs incurred.  In any appeal taken or brought by
Achaogen, whether at its election or at Microgenics request, Microgenics shall
cooperate fully with Achaogen in its prosecution thereof in every reasonable
manner and Microgenics shall be afforded reasonable opportunity to participate
in the prosecution thereof to the extent Microgenics’s interest may be
affected.  To the extent requested by Achaogen, Microgenics shall prosecute for
Achaogen any appeal taken or brought at Microgenics request and, in such event,
Achaogen shall assist Microgenics in every reasonable manner.

 

(g)

If Achaogen is required to certify any claim of Microgenics, Achaogen shall not
forward such claim unless it is reasonably satisfied the claim is in good faith,
and Achaogen can certify such claim to the Contracting Officer to the extent and
manner required by the Contract Disputes Act, as applicable.  Microgenics agrees
to provide Achaogen with such information as Achaogen reasonably may deem
necessary to make this determination, including but not limited to, its own
certification in the form prescribed by the Contract Disputes Act or its
implementing regulations.  Such certification shall be executed by a person duly
authorized to bind Microgenics.  Microgenics agrees that, with respect to any
claim or dispute that arises under or relates to the Prime Contract which, if it
were Achaogen’s claim, can properly be submitted for a decision of the
Contracting Officer under the “Disputes” clause, its right of claim or appeal is
limited to the procedures set forth in this provision.

 

(h)

Microgenics’s failure to comply with the terms of this provision shall entitle
Achaogen to terminate any such appeal on Microgenics’s behalf.  The rights and
obligations described herein shall survive completion of and final payment under
this Disputes section.

 

3.2

Other Disputes Any dispute arising under or related to this Agreement which
relates to a matter for which Achaogen has recourse against the Government under
the Prime Contract shall be resolved in accordance with Subsection 3.1.  In the
event of any dispute between the

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Parties arising out of or in connection with this Agreement that does not relate
to a matter for which Sponsor has recourse against the Government under the
Prime Contract, such dispute shall be resolved pursuant to Section 13.8 of the
Agreement.  

 

3.3

Choice of Law:   This Agreement is subject to and governed by the laws of the
State of Delaware, U.S.A. without regard to conflict of law principles, as
applicable except that any provision in this Agreement  that is (i) incorporated
in full text or by reference from the Federal Acquisition Regulation (FAR) or
(ii) incorporated in full text or by reference from any agency regulation that
implements or supplements the FAR or (iii) substantially based on any such FAR
provision or agency regulation, shall be construed and interpreted according to
the federal common law of government contracts as enunciated and applied by
federal judicial bodies, boards of contract appeals, and quasi-judicial agencies
of the federal government.  

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Appendix A
Government Provisions for Commercial Item Subcontracts
Under Contract Number HHSO100201000046C (BARDA Prime Contract)

The following provisions, as they may be amended by the United States Government
over time, are incorporated by reference with the same force and effect as if
set forth in full text and shall be deemed to apply solely to such portions of
work as are funded using Government funds.  For the purposes of this Agreement,
the term “contract” shall mean this Agreement; the terms “Contractor” and
“Company” shall mean Microgenics; the term “prime contractor” shall mean
Achaogen; and the terms “Government” and “Contracting Officer” may mean Achaogen
or the United States Government as expressly indicated on this document.   The
dollar amount listed parenthetically in the titles of some referenced clauses in
this Appendix A is the applicability threshold for the clause.  If the total
cumulative amount invoiced by Microgenics for all Government Sponsored Projects
performed under the BARDA Prime Contract is expected to exceed this amount, the
clause applies.

Federal Acquisition Regulation

Clause

Date

Title

FAR 52.202-1

Jul-04

Definitions (Over $100,000)

FAR 52.203-3

Apr-84

Gratuities (Over $100,000)

FAR 52.203-5

Apr-84

Covenant Against Contingent Fees (Over $100,000). Substitute “Achaogen ” for
“Government” or “United States” in paragraph (a) of this clause, provided
however that Achaogen may annul the contract or deduct amounts only to the
extent of a Government annulment or deduction due to conduct of Microgenics.

FAR 52.203-6

Sep-06

Restrictions on Subcontractor Sales to the Government (Over $100,000)

FAR 52.203-7

Jul-95

Anti-Kickback Procedures (Over $100,000)

FAR 52.203-8

Jan-97

Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Over $100,000). Substitute “Achaogen ” for “Government” or “United States”
throughout this clause, provided however that Achaogen may rescind the contract
and recover funds only to the extent of a Government rescission or recovery due
to conduct of Microgenics.

FAR 52.203-10

Jan-97

Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
Substitute “Achaogen ” for “Government” or “United States” throughout this
clause and “Achaogen” for “Contracting Officer” throughout this clause, provided
however that Achaogen may make a reduction only to the extent that the
Government makes a reduction due to conduct of Microgenics.

FAR 52.203-12

Sep-07

Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)

FAR 52.203-13

Apr-10

Contractor Code of Business Ethics and Conduct (applies if Agreement is over
$5,000,000 and has a performance period greater than 120 days). Disclosures made
under this clause shall be made directly to the government entities listed in
the clause.

FAR 52.203-14

Dec-07

Display of Hotline Poster(s).  (d) Subcontracts. The Contractor shall include
the substance of this clause, including this paragraph (d), in all subcontracts
that exceed $5,000,000, except when the subcontract—(1) Is for the acquisition
of a commercial item; or (2) Is performed entirely outside the United States.

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Clause

Date

Title

FAR 52.209-6

Sep-06

Protecting the Government’s Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $30,000)

FAR 52.215-2

Mar 09

Audit and Records- Negotiation (Over $100,000) (Only Government receives access
and audit rights under this clause)

FAR 52.215-21

Oct-97

Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing
Data—Modifications. Substitute “Achaogen” for “Contracting Officer” throughout
this clause, provided however, that Achaogen may seek from Microgenics only such
information as the Government has requested, and Microgenics shall deliver any
such information directly and only to the Government.  FAR 52.215-21 (as
modified above) shall apply only with respect to modifications funded by the
Government; FAR 52.215-21 shall not apply to modifications that are not funded
by the Government.  

FAR 52.219-8

May-04

Utilization of Small Business Concerns (Over $100,000)

FAR 52.222-3

Jun-03

Convict Labor

FAR 52.222-21

Feb-99

Prohibition of Segregated Facilities

FAR 52.222-26

Mar-07

Equal Opportunity (Over $10,000)

FAR 52.222-35

Sept-06

Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Over $100,000)

FAR 52.222-36

Jun-98

Affirmative Action for Workers with Disabilities (Over $10,000)

FAR 52.222-37

Sep-06

Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Over $100,000)

FAR 52.222-39

Dec-04

Notification of Employee Rights Concerning Payment of Union Dues or
Fees.  Applicable if value of this Agreement equals or exceeds $100,000.  

FAR 52.222-50

Feb-09

Combating Trafficking in Persons

FAR 52.222-54

Jan-09

Employment Eligibility Verification. Applicable to services and construction
subcontracts that: (1) exceed $3,000; and (2) include work performed in the
United States.  This clause does not apply to subcontracts for commercial
services that are (a) part of the purchase of a Commercially Available Off the
Shelf (COTS) item (or an item that would be a COTS item, but for minor
modifications) (b) performed by the COTS provider, and (c) are normally provided
for that COTS item.

FAR 52.223-6

May-01

Drug-Free Workplace

FAR 52.224-1

Apr-84

Privacy Act Notification (If subcontract requires design, development, or
operation of a system of records)

FAR 52.224-2

Apr-84

Privacy Act (If subcontract requires design, development, or operation of a
system of records)

FAR 52.225-1

Feb-09

Buy American Act- Supplies

FAR 52.225-13

Jun-08

Restrictions on Certain Foreign Purchases

FAR 52.227-1

Dec-07

Authorization and Consent, Alternate I (Apr 1984) (Over $100,000)

FAR 52.227-2

Dec-07

Notice and Assistance Regarding Patent and Copyright Infringement  (Over
$100,000). Substitute “Achaogen” for “Contracting Officer” throughout this
clause.  Insert “or Achaogen” after “Government” throughout this clause.

 

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Clause

Date

Title

FAR 52.227-11

Dec-07

Patent Rights –Ownership by the Contractor (Only Government receives license;
Achaogen receives no license.)  (Note: In accordance with FAR 27.303(b)(2),
paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i)
through (iv). The frequency of reporting in (i) is annual. Microgenics shall
provide to Achaogen a copy of any notice or election that Microgenics submits to
the Contracting Officer pursuant to subparagraph (c)(1), (c)(2) and (e)(3).  

FAR 52.227-16

Jun-87

Additional Data Requirements.  Substitute “Achaogen” for “Contracting Officer”
throughout this clause, provided however, that Achaogen may order from
Microgenics only such data that the Government has ordered and provided further
that the following data are hereby specifically identified for purposes of FAR
52.227-16(b), and are not subject to disclosure obligations under FAR 52.227-16,
and shall not be disclosed:  (i) Immunoassay Technologies (as defined in Section
1.16); (ii) Microgenics Know-How (as defined in Section 1.18) related to
Immunoassay Technologies; and (iii) any and all limited rights data (i.e., data
that embody trade secrets or are commercial or financial and confidential or
privileged, to the extent such data pertain to items, components, or processes
developed at private expense, including minor modifications) not already
included in (i) or (ii).

FAR 52.242-15

Aug-89

Stop Work Order (April 1984) (Achaogen may issue stop work order only to the
extent the Government issues a stop work order) Substitute “Achaogen” for
“Contracting Officer” throughout this clause.

FAR 52.244-5

Dec-96

Competition in Subcontracting

FAR 52.244-6

Jun-10

Subcontracts for Commercial Items

FAR 52.245-1

Aug-10

Government Property Applicable where government property involved in performance
of subcontract; "Contracting Officer" means “Achaogen” except in the definition
of Property Administrator and in paragraph h(1)(iii) and where it is unchanged,
and in paragraphs (c) and (h)(4) where it includes Achaogen.  "Government" is
unchanged in the phrases "Government property" and "Government furnished
property" and where elsewhere used except in paragraph (d)(1) where it means
Achaogen and except in paragraphs (d)(2) and (g) where the term includes
Achaogen.

 

the Department of Health and Human Services
Supplemental Regulation provisions

Clause

Date

Title

HHSAR 352.203-70

Jan-06

Anti-lobbying

HHSAR 352.223-70

Jan-06

Safety and Health

HHSAR 352.224-70

Jan-06

Privacy Act (if subcontract requires design, development, or operation of a
system of records)

HHSAR 325.242-73

Jan-06

Withholding of Contract Payments

HHSAR 352.270-4

Jan-06

Protection of Human Subjects

HHSAR 352.270-5

Jan-06

Care of Live Vertebrate Animals

HHSAR 352.270-6

Jan-06

Restriction on Use of Human Subjects

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HHSAR 352.227-70

Jan-06

Publications and Publicity

 

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BARDA Required Provisions

Prime Contract Provision

Clause

H.2: Human Materials

The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by Company in full
compliance with applicable State and Local laws and the provisions of the
Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.

Company shall provide Achaogen with written documentation that all human
materials obtained as a result of research involving human subjects conducted
under this contract, by collaborating sites, or by subcontractors identified
under this Agreement were obtained with prior approval by the Office for Human
Research Protections of an Assurance to comply with the requirements of 45 CFR
46 to protect human research subjects.

Provision by Company to Achaogen of a properly completed “Protection of Human
Subjects Assurance Identification/IRB Certification/Declaration of Exemption,”
Form OMB No. 0990-0263 (formerly optional form 310), certifying IRB review and
approval of the protocol from which the human materials were obtained
constitutes the written documentation required.

H.3: Research Involving Human Fetal Tissue

All research involving human fetal tissue shall be conducted in accordance with
the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2.  Implementing
regulations and guidance for conducting research on human fetal tissue may be
found at 45 C.F.R. 46, Subpart B, and
http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any
subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.

Company shall make available, for audit by Achaogen, the secretary, HHS, the
physician statements and informed consents required by 42 U.S.C. 289g-1(b) and
(c), or ensure HHS access to those records, if maintained by an entity other
than the Contractor.

H.4: Needle Exchange

Company shall not use contract funds to carry out any program of distributing
sterile needles or syringes for the hypodermic injection of any illegal drug.

H.5:  Press Releases

Company shall clearly state, when issuing statements, press releases, requests
for proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (1) the percentage of
the total costs of the program or project which will be financed with Federal
money; (2) the dollar amount of Federal funds for the project or program; and
(3) the percentage and dollar amount of the total costs of the project or
program that will be financed by nongovernmental sources.

H.7:  Animal Welfare

All research involving live, vertebrate animals shall be conducted in accordance
with the Public Health Service Policy on Humane Care and Use of Laboratory
Animals. This policy may be accessed
at:  http://grants1.nih.gov/grants/olaw/references/phspol.htm.

H.8:  Protection of Personnel who Work with Nonhuman Primates

All Company personnel who work with nonhuman primates or enter rooms or areas
containing nonhuman primates shall comply with the procedures set forth in NIH
Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with
Nonhuman Primates,” located at the following
URL:  http://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/

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Prime Contract Provision

Clause

H.9:  Publications and Publicity

No information related to data obtained under this contract shall be released or
publicized without the prior written consent of Achaogen and the Contracting
Officer Technical Representative.

In addition to the requirements of HHSAR 352.227-70, Publications and Publicity
incorporated by reference in section I of this contract shall acknowledge the
support of the Biomedical Advanced Research and Development Authority whenever
publicizing the work under this contract in any media by including an
acknowledgment substantially as follows:

“This project has been funded in whole or in part with Federal funds from the
Biomedical Advanced Research and Development Authority, office of the Assistant
Secretary for Preparedness and response, Office of the Secretary, Department of
Health and Human Services, Under Contract No. HHSO100201000046C.”

H.10:  Reporting Matters Involving Fraud, Waste and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in BARDA funded programs is encouraged to report such matters to the
HHS Inspector General’s Office in writing or on the Inspector General’s Hotline.
The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls
will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the
mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C.  20026.

H.11  Prohibition on Contractor Involvement with Terrorist Activities

Company acknowledges that U.S. Executive Orders and Laws, including but not
limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the
provision of resources and support to, individuals and organizations associated
with terrorism. It is the legal responsibility of Company to ensure compliance
with these Executive Orders and Laws. This clause must be included in all
subcontracts issued under this contract.

H.15:  Privacy Act Applicability

Notification is hereby given that Company and its employees are subject to
criminal penalties for violation of the Privacy Act to the same extent as
employees of the Government.

H.16: Laboratory license requirement

Company shall comply with all applicable requirements of Section 353 of the
Public Health Service Act (Clinical Laboratory Improvement Act as
Amended).  This requirement shall also be included in any subcontract for
services under this contract.

The parties anticipate that no part of the performance of this Agreement will be
subject to the Clinical Laboratory Improvement Act As Amended.

H.17:  Dissemination of Information

Except for any application to the FDA for approval of a diagnostic, any
publication in connection with such FDA filing or approval, and any filing in
connection with obtaining patent protection, no information related to data
obtained under this contract shall be released or publicized without the prior
written consent of the Contracting officer, to be obtained through Achaogen.

H.18:  Identification and Disposition of Data

Company will be required to provide certain data generated under this contract
to the Department of Health and Human Services (DHHS).  DHHS reserves the right
to review any other data determined by DHHS to be directly related to and/or
generated under this contract.  Company shall keep copies of all data required
by the Food and Drug Administration (FDA) relevant to this contract for the time
period specified by the FDA.

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Prime Contract Provision

Clause

H.19:  Information on Compliance With Animal Care Requirements

Registration with the U.S. Dept. of Agriculture (USDA) is required to use
regulated species of animals for biomedical purposes.  USDA is responsible for
the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq),
http://www.nal.usda.gov/awic/legislat/awa.htm

The Public Health Service (PHS) Policy is administered by the Office of
Laboratory Animal Welfare (OLAW)
http://grants2.nih.gov/grants/olaw/olaw.htm.  An essential requirement of the
PHS Policy, http://grants2.nih.gov/grants/olaw/references/phspol.htm is that
every institution using live vertebrate animals must obtain an approved
assurance from OLAW before they can receive funding from any component of the
U.S. Public Health Service.

The PHS Policy requires that Assured institutions base their programs of animal
care and use on the Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/readingroom/books/labrats/ and that they comply with the
regulations (9 C.F.R., subchapter A)
http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S. Department
of Agriculture (USDA) under the Animal Welfare Act.  The Guide may differ from
USDA regulations in some respects.  Compliance with USDA regulations is an
absolute requirement of this Policy.

The Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) http://www.aaalac.org is a professional organization that
inspects and evaluates programs of animal care institutions at their request.  
Those that meet the high standards are given accredited status.  As of the 2002
revision of the PHS policy, the only accrediting body recognized by PHS is the
AAALAC.  While AAALAC Accreditation is not required to conduct biomedical
research, it is highly desirable. AAALAC uses the Guide as their primary
evaluation tool.  They also use the Guide for the Care and Use of Agricultural
Animals in Agricultural Research and Teaching.   It is published by the American
Science Societies.  http://www.fass.org.

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Prime Contract Provision

Clause

H.20:  Requirements for Adequate Assurance of Protection of Vertebrate Animal
Subjects

The PHYS Policy on Humane Care and Use of Laboratory Animals requires that
applicant organizations proposing to use vertebrate animals file a written
Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW),
establishing appropriate policies and procedures to ensure the humane care and
use of live vertebrate animals involved in research activities supported by the
PHS.  The PHS Policy stipulates that an applicant organization, whether domestic
or foreign, bears responsibility for the humane care and use of animals in
PHS-supported research activities.  Also the PHS policy defines “animal” as “any
live, vertebrate animal used, or intended for use, in research, research
training, experimentation, biological testing or for related purposes.”  This
policy implements and supplements the U.S. Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing, Research, and
Training, and requires that institutions use the Guide for the Care and Use of
Laboratory Animals as a basis for developing and implementing an institutional
animal care use program.  This Policy does not affect applicable State or local
laws or regulations that impose more stringent standards for the care and use of
laboratory animals.  All institutions are required to comply, as applicable,
with the Animal Welfare Act, as amended and other Federal statutes and
regulations relating to animals.  These documents are available from the Office
of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892,
(301) 496-7163. http://grants.nih.gov/grants/olaw/olaw.htm.

No PHYS supported work or research involving vertebrate animals will be
conducted by an organization, unless that organization is operating in
accordance with an approved Animal Welfare Assurance and provides verification
that the Institutional Animal Care and Use Committee (IACUC) has reviewed and
approved the proposed activity in accordance with the PHS policy.  Applications
may be referred by the PHS back to the institution for further review in the
case of an apparent or potential violations of the PHS policy.  No award to an
individual will be made unless that individual is affiliated with an assured
organization that accepts responsibility for compliance with the PHS
Policy.  Foreign applicant organizations applying for PHS awards for activities
involving vertebrate animals are required to comply with PHS Policy or provide
evidence that acceptable standards for the humane care and use of animals will
be met.  Foreign applicant organizations are not required to submit IACUC
approval, but should provide information that is satisfactory to the Government
to provide assurances for the humane care of such animals.

H.21: Approval of Required Assurance by OLAW

Under governing regulations, federal funds which are administered by DHHS,
Office of Biomedical Advanced Research and Development Authority (BARDA) shall
not be expended by the contractor for research involving live vertebrate
animals, nor shall live vertebrate animals be involved in research activities by
Company under this award unless a satisfactory assurance of compliance with 7
U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date
of this award and approved by the Office of Laboratory Animal Welfare
(OLAW).  Each performance site (if any) must also assure compliance, with the
following restriction:  Only activities which do not directly involve live
vertebrate animals (i.e., are clearly severable and independent from those
activities) may be conducted by the contractor or individual performance sites
pending OLAW approval of their respective assurance of compliance.

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Prime Contract Provision

Clause

H.22:  Registration with the Select Agent Program for Work involving the
possession, use, and/or transfer of select biological agents or toxins

Company shall not conduct work involving select agents or toxins under this
contract until it and any associated subcontractor(s) comply with the following:

For prime or subcontract awards to domestic institutions that possess, use,
and/or transfer Select Agents under this contract, the institution must comply
with the provisions of 42 C.F.R. part 73, 7 C.F.R. part 331, and/or 9 C.F.R.
part 121 (
http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ) as
required, before using NIH funds for work involving a Select Agent or Toxin. No
government funds can be used for research involving a Select Agent or Toxin at a
domestic institution without a valid registration certificate.

For prime or subcontract awards to foreign institutions that possess, use,
and/or transfer a Select Agent or Toxin, before using NIH funds for any work
directly involving a Select Agent or Toxin, the foreign institution must provide
information satisfactory to the government that safety, security, and training
standards equivalent to those described in 42 C.F.R. part 73, 7 C.F.R. part 331,
and/or 9 C.F.R. part 121 are in place and will be administered on behalf of all
Select Agent or Toxin work supported by these funds. The process for making this
determination includes inspection of the foreign laboratory facility by a
government representative. During this inspection, the foreign institution must
provide the following information: concise summaries of safety, security, and
training plans; names of individuals at the foreign institution who will have
access to the Select Agents and procedures for ensuring that only approved and
appropriate individuals, in accordance with institution procedures, will have
access to the Select Agents under the contract; and copies of or links to any
applicable laws, regulations, policies, and procedures applicable to that
institution for the safe and secure possession, use, and/or transfer of select
agents. No funds can be used for work involving a Select Agent or Toxin at a
foreign institution without written approval from Achaogen.

Listings of HHS select agents and toxins, and overlap select agents or toxins as
well as information about the registration process for domestic institutions,
are available on the Select Agent Program Web site at http://
www.cdc.gov/od/sap/ and http://www.cdc.gov/od/sap/docs/salist.pdf.

Listings of USDA select agents and toxins as well as information about the
registration process for domestic institutions are available on the APHIS/USDA
website at: http://www.aphis.usda.gov/programs/ag_selectagent/ index.html and:
http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html

For foreign institutions, see the NIAID Select Agent Award
information:  http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm.

H.23:  EPA Energy Star Requirements

All microcomputers, including personal computers, monitors, and printers
purchased with government funds in the performance of a contract shall be
equipped with or meet the energy efficient low-power standby feature as defined
by the EPA Energy Star program unless the equipment always satisfies Energy Star
efficiency levels.

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Prime Contract Provision

Clause

H.24:  Acknowledgement of Federal Funding

(a)Section 507 of P.L. 104-208 mandates that contractors funded with Federal
dollars, in whole or in part, acknowledge Federal funding when issuing
statements, press releases, requests for proposals, bid solicitations and other
documents. Contractors are required to state (1) the percentage and dollar
amounts of the total program or project costs financed with federal money, and
(2) the percentage and dollar amount of the total costs financed by
nongovernmental sources.  This requirement is in addition to the continuing
requirement to provide an acknowledgement of support and disclaimer on any
publication reporting the results of a contract funded activity.

(b)Publication and Publicity.  The contractor shall acknowledge the support of
the Department of Health and Human Service, Office of the Assistant Secretary
for Preparedness and Response, Biomedical Advanced Research and Development
Authority whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:  “This project has been
funded in whole or in part with Federal funds from the Office of the Assistant
Secretary for Preparedness and Response, Biomedical Advanced Research and
Development Authority, under Contract no. HHSO100201000046C.

(c)Press Releases.  Pursuant to Section 508 of Public Law 105-78, the contractor
shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or programs
funded in whole or in part with federal money that: (1) the percentage of the
total costs of the program or project which will be financed with federal money;
(2) the dollar amount of Federal funds for the project or program; and (3) the
percentage and dollar amount of the total costs of the project or program that
will be financed by nongovernmental sources.

H.25:  Manufacturing Standards

The Current Good Manufacturing Practice Regulations (“cGMP”) (21 C.F.R. Parts
210-211) and regulations pertaining to biological products (21 C.F.R. Part 600)
will be the standard to be applied for manufacturing, processing, packing,
storage, and delivery of this product.

If at any time during the life of the contract, Company fails to comply with
cGMP in the manufacturing, processing and packaging of this product and such
failure results in a material adverse effect on the safety, purity or potency of
this product (a material failure), the Contractor shall have thirty (30)
calendar days from the time such material failure is identified to cure such
material failure.  If the Contractor fails to take such an action within the
thirty (30) calendar day period, then the contract may be terminated for
default.

H.26:  Export Control Notification

Company is responsible for ensuring compliance with all export control laws and
regulations that may be applicable to the export of and foreign access to their
proposed technologies.

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Prime Contract Provision

Clause

H.27:  Institutional responsibility Regarding Conflicting Interests of
Investigators

Company shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing
standards to ensure that investigators (defined as the principle investigator
and any other person who is responsible for design, conduct, or reporting of
research funded under BARDA contracts) will not be biased by any conflicting
financial interest.  For the purposes of this part relating to financial
interest, “investigator” includes the investigator’s spouse and dependent
children.

Company shall at a minimum:

(a)Maintain a written, enforceable policy on conflict of interest and inform
each investigator of the policy, the investigator’s reporting responsibilities,
and the applicable regulations. The contractor must take reasonable steps to
ensure that investigators working as collaborators or subcontractors comply with
the regulations.

(b)Designate and official to review financial disclosure statements from each
investigator participating in BARDA-funded research. Based on established
guidelines consistent with the regulations, the designated official must
determine whether a conflict of interest exists, and if so, determine what
actions should be taken to manage, reduce, or eliminate such a conflict.

(c)Require updating of financial disclosure statements during the period of
award.

(d)Maintain records taken under this provision for three years after final
payment.

(e)Establish adequate enforcement mechanisms.

If a conflict of interest is identified, the Institution shall report to
Achaogen the existence of the conflicting interest found. This report shall be
made and the conflicting interest managed, reduced, or eliminated, at least on a
temporary basis, within thirty (30) days of that identification.

 

Order Of Precedence

In the event of a conflict between the terms of this Appendix and any term of
the Agreement or an Exhibit or other appendix issued there under, the terms of
this Appendix shall govern.

 

 

 

 

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