Exhibit 10.3

 

[* * *] Portions of this exhibit that are both not material and would likely
cause competitive harm to the registrant if publicly disclosed have been omitted
pursuant to Item 601(b)(10)(iv) of Regulation S-K.

 

COLLABORATION AGREEMENT

This Collaboration Agreement (this “Agreement”) is made as of July 17, 2020 (the
“Effective Date”), by and between Assembly Biosciences, Inc., a corporation
organized and existing under the laws of Delaware (“AssemblyBio”), having a
place of business at 331 Oyster Point Blvd., 4th Floor, South San Francisco, CA
94080, and BeiGene, Ltd., a Cayman Island exempted company incorporated with
limited liability (“BeiGene”), having a place of business at c/o Mourant
Governance Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, PO Box
1348, Grand Cayman KY1-1108, Cayman Islands. AssemblyBio and BeiGene are
referred to in this Agreement individually as a “Party” and collectively as the
“Parties.”

BACKGROUND

A.AssemblyBio is a biopharmaceutical company that is developing proprietary
compounds known as ABI-H0731, ABI-H2158, and ABI-H3733 for the treatment of
hepatitis B (HBV) and controls certain patents and know-how relating to such
compounds;

B.BeiGene is a biopharmaceutical company engaged in the research, development
and commercialization of pharmaceutical products;

C.BeiGene wishes to obtain from AssemblyBio an exclusive license to develop and
commercialize ABI-H0731, ABI-H2158, and ABI-H3733 in the Field in the Territory,
and AssemblyBio is willing to grant such a license to BeiGene, all in accordance
with the terms and conditions set forth herein; and

D.The Parties originally entered into the Agreement as of the Effective
Date.  The Parties are re-executing this version of the Agreement as of November
2, 2020 to correct certain section and exhibit references.  The Parties
acknowledge and agree this version supersedes and replaces in its entirety,
effective as of the Effective Date, the version of this Agreement previously
executed by the Parties as of the Effective Date.

Now Therefore, in consideration of the mutual covenants and agreements contained
herein below, and other good and valuable consideration, the sufficiency of
which is hereby acknowledged by both Parties, the Parties agree as follows:

-1-

--------------------------------------------------------------------------------

Article 1

DEFINITIONS & INTERPRETATION

Whenever used in this Agreement with an initial capital letter, the terms
defined in this Article 1 and elsewhere in this Agreement, whether used in the
singular or plural, shall have the meanings specified.

1.1“Accounting Standard” means (a) with respect to AssemblyBio, GAAP, and (b)
with respect to BeiGene, GAAP (or IFRS, if applicable, in connection with an
assignment to an Affiliate under Section 16.2), in both cases (a) and (b),
consistently applied.

1.2“Acquiring Entity” means a Third Party that merges or consolidates with or
acquires a Party, or to which a Party transfers all or substantially all of its
assets to which this Agreement pertains.

1.3“Active Ingredient” means the clinically active material(s) that provide
pharmacological activity in a pharmaceutical product (excluding formulation
components such as coatings, stabilizers, excipients or solvents, adjuvants or
controlled release technologies).

1.4“Affiliate” means, with respect to a Person, any other Person controlling,
controlled by or under common control with such Person, for so long as such
control exists.  For purposes of this Section 1.4 only, “control” means
(a) direct or indirect ownership of fifty percent (50%) or more of the stock or
shares having the right to vote for the election of directors of such corporate
entity or (b) the possession, directly or indirectly, of the power to direct, or
cause the direction of, the management or policies of such entity, whether
through the ownership of voting securities, by contract or otherwise.

1.5“Applicable Laws” means collectively all laws, regulations, ordinances,
decrees, judicial and administrative orders (and any license, franchise, permit
or similar right granted under any of the foregoing) and any policies and other
requirements of any applicable Governmental Authority that govern or otherwise
apply to a Party’s activities in connection with this Agreement.

1.6“AssemblyBio Ancillary Trials” means the Clinical Trials conducted to support
the Regulatory Submissions for any Licensed Product, which include DDI studies,
ADME studies, studies of a Licensed Product in certain subpopulations (e.g.
renal or hepatic impairment studies) or certain safety Clinical Trials as may be
required by the applicable Regulatory Authorities (e.g. thorough QT/QTc
assessment studies).

1.7“AssemblyBio Collaboration IP” means all Inventions that are owned solely by
AssemblyBio pursuant to Section 14.1(a).

1.8“AssemblyBio IP” means, collectively, AssemblyBio Know-How and AssemblyBio
Patent Rights.

1.9“AssemblyBio Know-How” means all Know-How, except to the extent excluded
subject to Sections 5.5(b) and 5.5(c), which: (a) is Controlled by AssemblyBio
or any of its Affiliates as of the Effective Date or during the Term of this
Agreement, (b) is not generally known, and (c) is necessary or reasonably useful
for the Development, Manufacture or

-2-

--------------------------------------------------------------------------------

Commercialization of Licensed Products (excluding Other Components in any
Combination Product) in the Field in the Territory, including all Know-How
included as part of AssemblyBio Collaboration IP.

1.10“AssemblyBio Patent Rights” means all Patent Rights which (a) are Controlled
by AssemblyBio or any of its Affiliates as of the Effective Date or at any time
during the Term and (b) are necessary or reasonably useful (or, with respect to
patent applications, would be necessary or reasonably useful if such patent
applications were to issue as patents) for the Development, Manufacture or
Commercialization of Licensed Products (excluding Other Components in any
Combination Product) in the Field in the Territory, including all Patent Rights
in the Territory claiming Product-Specific IP, AssemblyBio’s interest in the
Joint Patent Rights and all other Patent Rights claiming AssemblyBio
Collaboration IP.  

1.11“BeiGene Collaboration IP” means all Inventions that are owned solely by
BeiGene pursuant to Section 14.1(a).

1.12“BeiGene IP” means all Patent Rights and Know-How (except to the extent
excluded subject to Section 5.5(b)) that (i) are Controlled by BeiGene as of the
Effective Date or (ii) thereafter come into BeiGene’s Control independent of
this Agreement, and in each case, that are generated, used or applied by or on
behalf of BeiGene or its Affiliates or sublicensees in the Development,
Manufacture or Commercialization of Licensed Products. For clarity, “BeiGene IP”
does not include Product-Specific IP.

1.13“BeiGene Patent Rights” means all Patent Rights in the BeiGene IP.

1.14“Business Day” means a day other than (a) a Saturday or Sunday, and (b) any
other day on which banking institutions in San Francisco, California or Beijing,
China are authorized or required by Applicable Laws to remain closed.

1.15“Calendar Quarter” means the period beginning on the Effective Date and
ending on the last day of the calendar quarter in which the Effective Date
falls, and thereafter each successive period of three (3) consecutive calendar
months ending on March 31, June 30, September 30 and December 31; provided that
the final Calendar Quarter shall end on the last day of the Term.

1.16“Calendar Year” means the period beginning on the Effective Date and ending
on December 31 of the calendar year in which the Effective Date falls, and
thereafter each successive period of twelve (12) months commencing on January 1
and ending on December 31; provided that the final Calendar Year shall end on
the last day of the Term.

1.17“cGMP” means applicable current Good Manufacturing Practices, including, as
applicable, (a) the principles detailed in the U.S. Current Good Manufacturing
Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive
2003/94/EC and Eudralex 4, (c) China Food and Drug Administration Ministry of
Health Decree No. 79 for Good Manufacturing Practice for Drugs, effective as of
March 1, 2011, (d) the principles detailed in the International Conference on
Harmonization’s Q7 guidelines, and (e) the Applicable Laws in any relevant
country or region corresponding to (a) through (d) above, each as may be amended
and applicable from time to time.  

-3-

--------------------------------------------------------------------------------

1.18“China” means the People’s Republic of China, which for the purposes of this
Agreement shall exclude Hong Kong, Macau and Taiwan.

1.19“Clinical Data” means, except to the extent excluded subject to Sections
5.5(b) and 5.5(c), (a) any and all data (together with all Clinical Trial
reports and the results of analyses thereof) derived from or generated in any
Clinical Trial, or (b) any and all pre-clinical or non-clinical data derived
from or generated in any Development activities under this Agreement, in both
cases (a) and (b), conducted by or on behalf of a Party.

1.20“Clinical Trial” means any human clinical trial of a Licensed Product in the
Field.

1.21“Clinical Trials Application” means an application or submission to the
competent Regulatory Authority for authorization to conduct a Clinical Trial in
the applicable jurisdiction.

1.22“CMO” means contract manufacturing organization.

1.23“Combination Product” means a Licensed Product that is (a) sold in a form of
a combination that contains or comprises a Licensed Compound and (i) one or more
additional Active Ingredients (whether coformulated or copackaged or otherwise
sold for a single price) other than a Licensed Compound, (ii) delivery device or
component therefor, (iii) companion diagnostic related to any Licensed Compound,
or (iv) product, process, service, or therapy other than the Licensed Compound
(the products, devices, processes, services, and therapies described in the
foregoing clauses (i) – (iv), each, an “Other Component”); or (b) defined as a
“combination product” by the FDA pursuant to 21 C.F.R. §3.2(e) or its foreign
equivalent, where such “combination product” is sold for a single
price.  Notwithstanding the foregoing, the License granted hereunder does not
expand to Other Components of the Combination Product.

1.24“Commercialization” or “Commercialize” means any and all activities directed
to the offering for sale and sale of any Licensed Product, including (a)
marketing, promoting, advertising, exhibiting, distributing, detailing, selling
(and offering for sale or contracting to sell) or otherwise commercially
exploiting a Licensed Product in the Field in the Territory (including importing
and exporting activities in connection therewith); (b) order processing,
handling of returns and recalls, booking of sales and transporting such Licensed
Product for commercial sale; (c) the conduct of any post-approval Clinical
Trials involving such Licensed Product; (d) interacting with Regulatory
Authorities regarding the above; (e) seeking and obtaining pricing approvals and
reimbursement approvals (as applicable) for that Licensed Product in the
Territory; (f) any pharmacoeconomic studies relating to the Indication for which
the applicable Licensed Product is being Developed; and (g) any investigator- or
institution-sponsored studies. For clarity, Commercialization does not include
activities directed to Development or Manufacture.  

1.25“Commercially Reasonable Efforts” means, (a) with respect to a Party’s
obligations or activities under this Agreement (other than those described in
clause (b)), the carrying out of such obligations or activities with a level of
effort and resources consistent with the commercially reasonable practices
normally devoted [* * *] in accordance with Applicable Laws; and (b) with
respect to the Development, Manufacture or Commercialization of the Licensed
Compounds and Licensed Products by a Party, the carrying out of such activities
with a

-4-

--------------------------------------------------------------------------------

level of effort and resources consistent with the commercially reasonable
practices normally devoted [* * *], taking into account all relevant factors,
including but not limited to, [* * *].  

1.26“Confidential Information” of a Party (a “Disclosing Party”) means, subject
to Section 10.2, all Know-How, which is generated by or on behalf of such
Disclosing Party under this Agreement and/or any other technical, scientific,
trade, research, manufacturing, business, financial, marketing, product,
supplier, intellectual property, and other non-public or proprietary data or
information that is disclosed by a Disclosing Party or its Affiliates to the
other Party (a “Receiving Party”) or its Affiliates pursuant to this Agreement
(including information disclosed prior to the Effective Date pursuant to the
Confidentiality Agreement) or which such Disclosing Party or any of its
Affiliates or contractors has provided or otherwise made available to the
Receiving Party, whether made available orally, in writing, or in electronic
form, including (a) such Know-How comprising or relating to concepts,
discoveries, Inventions, data, designs or formulae arising from this Agreement
and (b) any unpublished patent applications disclosed hereunder.  For purposes
of clarity, unless excluded pursuant to Section 10.2, (i) all Clinical Data and
results generated in any Joint Global Study shall be deemed Confidential
Information proprietary to AssemblyBio, subject to the rights of BeiGene to use
and reference such Clinical Data, without additional consideration, in
accordance with Sections 5.9 and 6.3; (ii) all Inventions shall be deemed the
Confidential Information of the owning Party as set forth in Section 14.1(a);
(iii) any scientific, technical, manufacturing or financial information,
including (except as set forth in (i) above) Clinical Data and information
disclosed through an audit report, Commercialization report, Development report
or other report, shall constitute Confidential Information of the Disclosing
Party; (iv) any combination of Confidential Information shall not be considered
in the public domain or in the possession of the Receiving Party merely because
individual elements of such Confidential Information are in the public domain or
in the possession of the Receiving Party unless the combination and its
principles are in the public domain or in the possession of the Receiving Party;
and (v) the existence and terms of this Agreement shall be deemed Confidential
Information of both of the Parties.

1.27“Control” or “Controlled” means with respect to any material, Know-How, or
intellectual property right (including Patent Rights), that a Party has the
power (whether by ownership, license, or otherwise other than pursuant to this
Agreement) to grant to the other Party access, a license, or a sublicense (as
applicable) to the same on the terms and conditions set forth in this Agreement
without violating any obligations of the granting Party to a Third Party.
Notwithstanding the foregoing, a Party will not be deemed to “Control” any
material, Know-How, or intellectual property right (including Patent Rights)
that, prior to the consummation of the merger, consolidation or transfer making
a Third Party an Acquiring Entity, is owned or in-licensed by such Third Party
that becomes an Affiliate of such acquired Party after the Effective Date as a
result of such acquisition transaction or that any Acquiring Entity subsequently
develops without accessing or practicing any AssemblyBio IP or BeiGene IP unless
(a) prior to the consummation of such acquisition transaction, such acquired
Party or any of its Affiliates also owned or in-licensed such Patent Right or
Know-How, or (b) the Know-How or Patent Rights owned or in-licensed by the
applicable Third Party were not used in the performance of activities under this
Agreement prior to the consummation of such acquisition transaction, but after
the consummation of such acquisition transaction, such acquired Party or any of
its Affiliates uses any such Patent Rights or Know-How in the performance of its
obligations or exercise of its rights

-5-

--------------------------------------------------------------------------------

under this Agreement, in each of which cases ((a) and (b)), such Patent Rights
or Know-How will be “Controlled” by such Party for purposes of this Agreement.

1.28“Cover” means, with respect to a Licensed Product in a particular country or
region that the manufacture, use, sale or importation of such Licensed Product,
as applicable, in such country or region would, but for the licenses granted
herein, infringe a Valid Claim.  Cognates of the word “Cover” shall have
correlative meanings.

1.29“Develop” or “Development” or “Developing” means all development activities
for any Licensed Compound or Licensed Product that are directed to obtaining
Regulatory Approval(s) of such Licensed Product and to support appropriate usage
for such Licensed Product in the Field, including: (a) all non-clinical and
preclinical testing and studies of such Licensed Product; (b) Clinical Trials;
(c) toxicology, pharmacokinetic, pharmacodynamic, drug-drug interaction, safety,
tolerability and pharmacological studies of such Licensed Product; (d)
distribution of such Licensed Product for use in Clinical Trials (including
placebos and comparators); (e) statistical analyses; (f) the preparation, filing
and prosecution of any NDA for such Licensed Product in the Territory, with
respect to Development activities conducted under the Territory Development
Plan, and the preparation, filing and prosecution of any Biological License
Application or New Drug Application (each as defined by the FDA) outside the
Territory, with respect to Development activities conducted under the Global
Development Plan; (g) all development activities directed to label expansion
(including prescribing information) or obtaining Regulatory Approval for one or
more additional Indications following initial Regulatory Approval; and (h) all
development activities conducted after receipt of Regulatory Approval that are
required or requested in writing by a Regulatory Authority as a condition of, or
in connection with, obtaining or maintaining a Regulatory Approval; and (i) all
regulatory activities related to any of the foregoing.  For clarity, Development
does not include activities directed to Manufacture or Commercialization.

1.30“Development and Regulatory Costs” means all internal and external costs and
expenses (including the cost of allocated FTEs at the FTE Rate) incurred by a
Party and its Affiliates (“Costs”) during the Term in connection with the
Development of Licensed Compounds or Licensed Products in accordance with the
Global Development Plan or Territory Development Plan:

(a)with respect to BeiGene, including, as applicable:

(i)all Costs incurred by BeiGene or its Affiliates in performing Development
activities in or for the Territory (including [* * *]);

(ii)all Costs incurred by BeiGene or its Affiliates for Licensed Compounds or
Licensed Products or any other materials (such as non‑Party comparator drugs and
placebo) reasonably required to be obtained or made for use in Clinical Trials
of or related to a Licensed Compound or Licensed Product; and

(iii)all Costs incurred by BeiGene or its Affiliates associated with obtaining,
maintaining and renewing Regulatory Submissions and Regulatory Approvals for a
Licensed Product;

-6-

--------------------------------------------------------------------------------

(b)with respect to AssemblyBio, including, as applicable:

(i)all Costs incurred by AssemblyBio or its Affiliates in performing Development
activities in and for the Territory (including [* * *]); and

(ii)all Costs incurred by AssemblyBio or its Affiliates for Licensed Compounds
or Licensed Products or any other materials (such as non‑Party comparator drugs
and placebo) reasonably required to be obtained or made for use in Clinical
Trials of or related to a Licensed Compound or Licensed Product in and for the
Territory (but excluding any such Costs taken into account in the calculation of
Fully Burdened Manufacturing Costs);

in both cases (a) and (b), (x) as set forth in the Global Development Budget or
the Territory Development Budget, (y) incurred in relation to activities
expressly set forth in the Global Development Plan, the Territory Development
Plan or this Agreement, and (z) evidenced by written records reasonably
acceptable to the other Party; provided that any Costs [* * *] may be counted as
Development and Regulatory Costs [* * *] (1) [* * *], (2) [* * *], and (3)
[* * *]. For clarity, any external or Third Party costs are included in the
Development and Regulatory Costs in the amount actually incurred without any
markup. All Development and Regulatory Costs must be recorded in accordance with
the applicable Accounting Standard, and either directly attributed to or fairly
allocable to the Development activities of the Licensed Compounds and Licensed
Products as conducted by the applicable Party.

1.31“Development Plan” means the Global Development Plan, the Territory
Development Plan or the ABI-H0731 Initial Development Plan.

1.32“[* * *]” means, with respect to a [* * *], (a) the [* * *] of such [* * *]
through (i) an [* * *] to a Third Party or (ii) an [* * *], with no further
rights or role or ability to [* * *], directly or indirectly, with respect to
such [* * *] such that neither the applicable Party nor its Affiliates are
consulted with respect to, and do not otherwise participate in, [* * *] (other
than those described in clauses (i) and (ii) above), or otherwise [* * *] with
any Third Party, with respect to the [* * *] or the [* * *]; or (b) the complete
[* * *] with respect to such [* * *]. For clarity, the right of the applicable
Party to receive royalties, milestones or other payments in connection with
[* * *] pursuant to sub-section (a) above, shall be permitted for any such
[* * *]. When used as a verb, “[* * *]” and “[* * *]” means to cause a [* * *].

1.33“[* * *]” means [* * *].

1.34“Exchange Act” means the United States Securities Exchange Act of 1934, as
amended.

1.35“FDA” means the United States Food and Drug Administration or any successor
entity thereto.

1.36“Field” means the diagnosis, treatment, palliation or prevention of all
indications, diseases and disorders in humans, provided that, with respect to
the In-Licensed Patent Rights, the “Field” will be limited to diagnosis and
treatment of all indications, diseases and disorders in humans.

-7-

--------------------------------------------------------------------------------

1.37“Finite Duration Therapy” means any labelled Indication for the treatment of
chronic HBV infection that [* * *].

1.38“First Commercial Sale” means, with respect to any Licensed Product in any
country or jurisdiction in the Territory, the first sale of such Licensed
Product by BeiGene, its Affiliates, or sublicensees to a Third Party for
distribution, use or consumption in such country or jurisdiction after obtaining
Regulatory Approvals, as applicable, have been obtained for such Licensed
Product in such country or jurisdiction; provided, that, the following shall not
constitute a First Commercial Sale of a Licensed Product: (a) any sale to an
Affiliate or sublicensee, (b) any use of a Licensed Product in Clinical Trials,
pre-clinical studies or other research or Development activities, or (c) the
[* * *].

1.39“FTE” means, with respect to a person the equivalent of the work of one (1)
employee full time for one (1) year (consisting of at least a total of [* * *]
per year, excluding vacations and holidays). Overtime, work on weekends,
holidays and the like will not be counted with any multiplier (e.g.,
time-and-a-half or double time) toward the number of hours that are used to
calculate the FTE contribution.  No one person shall be permitted to account for
more than one FTE.

1.40“FTE Rate” means, (a) for any employee of BeiGene conducting Development
activities, [* * *], and (b) for an employee of AssemblyBio, [* * *], in both
cases (a) and (b), increasing by [* * *] each January 1st beginning on January
1, [* * *]. The FTE Rate for each Party includes fully burdened personnel costs
(including taxes, benefits, overhead, general and administrative expenses,
related capital expenditures, etc.).

1.41“Fully Burdened Manufacturing Cost” means, with respect to any Licensed
Product supplied by or on behalf of AssemblyBio to BeiGene hereunder, and as
determined on a Calendar Quarter-by-Calendar Quarter basis:

(a)if such Licensed Product (or any precursor or intermediate thereof) is
Manufactured by a Third Party manufacturer, (i) the [* * *] costs of such supply
of such Licensed Product (or precursor or intermediate) incurred by AssemblyBio,
to the extent specifically identifiable or reasonably allocated to the supply of
such Licensed Product as determined in accordance with GAAP (including, but not
limited to, [* * *], the costs [* * *] of such Licensed Product (including
applicable [* * *])), and (ii) any internal or Third Party costs incurred by
AssemblyBio in connection with such Manufacturing by such Third Party, including
[* * *] at the FTE Rate, provided, that the costs described in this clause (ii)
[* * *]; or

(b)if such Licensed Product (or any precursor or intermediate thereof) is
Manufactured by AssemblyBio or its Affiliate, the actual, fully burdened
documented and verifiable direct and indirect costs and expenses incurred and
recorded in Manufacturing such Licensed Product “consisting solely of” (i) the
cost of [* * *] (including any costs incurred by AssemblyBio for time spent by
AssemblyBio personnel to [* * *], at the FTE Rate), [* * *], (ii) the reasonable
allocation of [* * *], to such manufacturing operation (including the allocable
costs of [* * *], if applicable, but excluding [* * *]; (iii) [* * *] (including
[* * *] but excluding any allocation for [* * *]); (iv) [* * *]; (v) [* * *];
(vi) [* * *]; and (vii) [* * *], in each case ((i) through (vii)), to the extent
allocable to the Manufacture of such Licensed Product as determined in
accordance with GAAP.

-8-

--------------------------------------------------------------------------------

1.42“GAAP” means United States generally accepted accounting principles,
consistently applied.

1.43“GCP” means all applicable Good Clinical Practice standards for the design,
conduct, performance, monitoring, auditing, recording, analyses and reporting of
Clinical Trials, including, as applicable (a) as set forth in the International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical
Practice (CPMP/ICH/135/95) (the “ICH Guidelines”) and any other guidelines for
good clinical practice for trials on medicinal products in the Territory, (b)
the Declaration of Helsinki (2004) as last amended at the 52nd World Medical
Association in October 2000 and any further amendments or clarifications
thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of
Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New
Drug Application), as may be amended from time to time, (d) the PRC Good
Clinical Practices for Pharmaceutical Products (药物临床试验质量管理规范), as released by
China National Medical Products Administration in 2003 and latest updated in
2020, and (e) the equivalent Applicable Laws in the region in the Territory,
each as may be amended and applicable from time to time and in each case, that
provide for, among other things, assurance that the clinical data and reported
results are credible and accurate and protect the rights, integrity, and
confidentiality of trial subjects.

1.44“Generic Product” means, with respect to a Licensed Product in a particular
region in the Territory, any pharmaceutical product that is being sold
commercially by a Third Party in such region in the Territory without
authorization by BeiGene (or its Affiliate or sublicensee), that (a) contains
the same Active Ingredient(s) as a Licensed Product, (b) is determined to be
bioequivalent to such Licensed Product in accordance with Applicable Laws, and
(c) is approved for sale in such region under an abbreviated route of regulatory
approval in such region similar to the Abbreviated New Drug Application, or
under 505(b)(2) of the United States Federal Food, Drug and Cosmetic Act, in the
U.S. and is sold under a Regulatory Approval granted to the selling Third Party
in such region which authorization is based substantially on clinical data
pertaining to such Licensed Product. For purposes of clarity, for regions in the
Territory where no explicit generic regulations exist, the term Generic Product
also shall mean any product that is authorized for sale by the applicable
Regulatory Authority in such region by a Third Party that contains the same
Active Ingredient(s) as a Licensed Product.

1.45“Global Commercialization Principles” means, with respect to a Licensed
Product, the written summary of the key principles and strategy for the
Commercialization of such Licensed Product in the Field worldwide (including in
the Territory) to be prepared by AssemblyBio and approved by the JCC in
accordance with this Agreement, as such written summary may be amended, modified
or supplemented by either Party and approved by the JCC in accordance with
Section 3.3(b).

1.46“GLP” means all applicable Good Laboratory Practice standards, including, as
applicable, (a) as set forth in the then-current good laboratory practice
standards promulgated or endorsed by the U.S. Food and Drug Administration, as
defined in 21 C.F.R. Part 58, (b) the Good Laboratory Practices for Nonclinical
Drug Research, as released by China National Medical Products Administration in
2017, and (c) the equivalent Applicable Laws in the Territory, each as may be
amended and applicable from time to time.

-9-

--------------------------------------------------------------------------------

1.47“Governmental Authority” means any federal, state, national, state,
provincial or local government, or political subdivision thereof, or any
multinational organization or any authority, agency or commission entitled to
exercise any administrative, executive, judicial, legislative, police,
regulatory or taxing authority or power, or any court or tribunal (or any
department, bureau or division thereof, or any governmental arbitrator or
arbitral body).

1.48“HBV Core Protein” means HBV core protein (Cp), a structural protein,
typically 183 or 185 amino acids long, that self assembles to form the HBV viral
capsid. The key mechanism which HBV Cp controls HBV replication is with specific
packaging of viral pgRNA and HBV polymerase protein into a viral capsid to
enable viral DNA replication.

1.49“Indication” means a generally acknowledged disease or condition, a
significant manifestation of a disease or condition, or symptoms associated with
a disease or condition or a risk for a disease or condition. For clarity, all
variants of a single disease or condition (e.g., variants of colon cancer or
variants of prostate cancer), whether classified by severity or otherwise, shall
be treated as the same Indication for purposes of this Agreement.

1.50“Invention” means any Know-How, composition of matter, article of
manufacture or other subject matter, whether patentable or not, that is
conceived or reduced to practice in the conduct of the Development, Manufacture,
or Commercialization of a Licensed Product under this Agreement.

1.51“Joint Global Study” means a global Clinical Trial or a set of global
Clinical Trials of a Licensed Product which include Clinical Trial sites in and
outside of the Territory.

1.52“Know-How” means all technical information, know-how, data, inventions,
discoveries, trade secrets, specifications, instructions, processes, formulae,
methods, protocols, expertise and other technology applicable to formulations,
compositions or products or to their manufacture, development, registration, use
or marketing or to methods of assaying or testing them, and all biological,
chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical
and analytical, safety, quality control, manufacturing, preclinical and clinical
data relevant to any of the foregoing. For clarity, Know-How excludes Patent
Rights and physical substances.

1.53“Licensed ABI-H0731 Product” means any Licensed Product containing ABI-H0731
as an Active Ingredient.

1.54“Licensed ABI-H2158 Product” means any Licensed Product containing ABI-H2158
as an Active Ingredient.

1.55“Licensed ABI-H3733 Product” means any Licensed Product containing ABI-H3733
as an Active Ingredient.

1.56“Licensed Compound” means AssemblyBio’s proprietary compounds: ABI-H0731,
ABI-H2158, and ABI-H3733 (collectively, the “Listed Compounds”), each with the
structure as set forth on Exhibit 1.56, and [* * *].

-10-

--------------------------------------------------------------------------------

1.57“Licensed Product” means any pharmaceutical, formulation or dosage form
containing any Licensed Compound, whether as its sole active ingredient or in
combination with one or more other active ingredients, in final finished form.

1.58“Manufacture” or “Manufacturing” means activities directed to process,
analytical and formulation development, manufacturing, processing, packaging,
labeling, filling, finishing, assembly, quality assurance, quality control,
testing, and release, shipping, or storage of the Licensed Compounds and
Licensed Products (or any components or process steps involving the Licensed
Compounds and Licensed Products), placebo, or comparator agent, as the case may
be, including process development, qualification, and validation, scale-up,
pre-clinical, clinical, and commercial manufacture and analytic development,
product characterization, and stability testing. For clarity, Manufacture does
not include activities directed to Development or Commercialization.

1.59“NDA” means a New Drug Application (as defined by the NMPA or other
applicable Regulatory Authorities in the Territory), or any successor
application for Regulatory Approval having substantially the same function, or
its foreign equivalent for approval to market or sell a pharmaceutical product
in the Territory.

1.60“Net Sales” means the gross amount invoiced by BeiGene, its Affiliates or
sublicensees (collectively, the “Sellers”) for sales or other transfers of
Licensed Product in bona fide arm’s length transactions to a Third Party
(including any Third Party distributors, collectively, the “Buyers”), less the
following deductions, [* * *]:

(a)[* * *], to the extent such [* * *] are not attributable to other products or
services of the Sellers that are unrelated to the sales and distribution of the
Licensed Product;

(b)[* * *], to the extent not otherwise attributable to other products or
services of the Sellers that are unrelated to the sales and distribution of the
Licensed Product;

(c)[* * *];

(d)[* * *] to the extent relating to the Licensed Product [* * *] in accordance
with the applicable Seller’s Accounting Standard, [* * *];

(e)[* * *] allowed or paid for [* * *]; and

(f)[* * *], in each case to the extent not reimbursed.

Each of the foregoing deductions shall be determined as incurred in the ordinary
course of business in type and amount consistent with good industry practice and
in accordance with the applicable accounting requirements on a basis consistent
with BeiGene’s audited consolidated financial statements. In the case of any
other sale [* * *], such as [* * *], of any Licensed Product, or part thereof,
other than [* * *], Net Sales shall be calculated as above [* * *], defined as
[* * *].  

For purposes of this Agreement, a “sale” or “transfer” shall mean any transfer
or other distribution or disposition, but shall not include transfers or other
distributions or dispositions of Licensed Product at no charge (i) for academic
research, preclinical, clinical, or regulatory purposes (including the use of a
Licensed Product in Clinical Trials), (ii) [* * *], or (iii) to

-11-

--------------------------------------------------------------------------------

physicians or hospitals for promotional purposes (including free samples to a
level and in an amount which is customary in the industry and which is
reasonably proportional to the market for such Licensed Product), to the extent
permitted under Applicable Laws in the Territory.

All deductions in clauses (a) through (f) above will be fairly and equitably
allocated between such Licensed Product and other products of the Sellers, such
that such Licensed Product does not bear a disproportionate portion of such
deductions. Calculations of Net Sales will be in accordance with the applicable
Seller’s Accounting Standard, consistently applied across all products of such
Seller and across periods. If a single item falls into more than one of the
categories set forth in clauses (a)-(f) above, then such item may not be
deducted more than once.

In the event that a Combination Product is sold in the Territory by or under the
authority of BeiGene or its Affiliate or sublicensee, Net Sales for the Licensed
Product included in such Combination Product shall be calculated by multiplying
the Net Sales (as calculated above but based on the gross invoice price of the
Combination Product) during the applicable reporting period by the fraction
A/(A+B), where “A” is the average sales price of the Licensed Product sold
separately, and “B” is the average sales price of the Other Components, in each
case, in the Territory during the applicable reporting period.  If sales of the
Licensed Product sold separately and of the Other Components did not occur
during the applicable reporting period, the respective average sales prices
during the most recent reporting period in which sales of both occurred in the
Territory shall be used. In the event that either or both of A or (and) B is
(are) not available in the Territory, then Net Sales for purposes of determining
royalty payments shall be [* * *].

1.61“NMPA” means the National Medical Products Administration of China, and
local counterparts thereto, and any successor agency(ies) or authority thereto
having substantially the same function.

1.62“[* * *]” means, with respect to a Licensed Product, the [* * *].

1.63“Patent Prosecution” means activities directed to (a) preparing, filing and
prosecuting applications (of all types) for any Patent Rights, (b) managing any
interference, opposition, re-issue, reexamination, supplemental examination,
invalidation proceedings (including inter partes or post-grant review
proceedings), revocation, nullification, or cancellation proceeding relating to
the foregoing, (c) deciding whether to abandon, extend or maintain Patent
Rights, (d) listing in regulatory publications (as applicable), and (e) settling
any interference, opposition, reexamination, invalidation, revocation,
nullification or cancellation proceeding, but excluding the defense of
challenges to such patent or patent application as a counterclaim in an
infringement proceeding with respect to the particular patent or patent
application, and any appeals therefrom.  For purposes of clarity, “Patent
Prosecution” will not include any other enforcement actions taken with respect
to a patent or patent application.

1.64“Patent Rights” means the rights and interests in and to issued patents and
pending patent applications (which, for purposes of this Agreement, include
certificates of invention, applications for certificates of invention and
priority rights) in any country or region, including all provisional
applications, substitutions, continuations, continuations-in-part, continued
prosecution applications including requests for continued examination,
divisional applications and renewals, and all letters patent or certificates of
invention granted thereon, and all reissues, reexaminations, extensions
(including pediatric exclusivity patent extensions), term restorations,
renewals,

-12-

--------------------------------------------------------------------------------

substitutions, confirmations, registrations, revalidations, revisions and
additions of or to any of the foregoing, in each case, in any country or region.

1.65“Person” means any individual, corporation, company, partnership,
association, joint-stock company, trust, unincorporated organization or
government or political subdivision thereof.

1.66“Phase 3 Clinical Trial” means a controlled or uncontrolled human Clinical
Trial of a Licensed Product that would satisfy the requirements of 21 CFR
312.21(c) or corresponding foreign regulations, regardless of whether such trial
is referred to as a “phase 3 clinical trial” in the Global Development Plan or
the Territory Development Plan.

1.67“Pricing and Reimbursement Approval” means the later of (a) the approval,
agreement, determination, or governmental decision establishing a price for the
applicable Licensed Product that can be legally charged to consumers, if
required in a given country or region for the Commercialization of such Licensed
Product in such country or region; and (b) the approval, agreement,
determination, or governmental decision establishing the level of reimbursement
for such Licensed Product that will be reimbursed by Governmental Authorities,
if either required or otherwise commercially beneficial in a given country or
region for the Commercialization of such Licensed Product in such country or
region.

1.68“Product-Specific IP” means all Inventions that are made jointly by the
Parties or solely by a Party that relate (a) to the composition of matter of, or
a method of using or detecting, a Licensed Compound or a Licensed Product, or
any companion or complementary diagnostic to a Licensed Product, or (b) to a
method of manufacturing specific to a Licensed Product.

1.69“Regulatory Approval” means all approvals from the relevant Regulatory
Authority necessary to initiate marketing and selling a product (including
Licensed Product) in any country or jurisdiction, excluding Pricing and
Reimbursement Approvals.  

1.70“Regulatory Authority” means any applicable Governmental Authority with
authority over the distribution, importation, exportation, manufacture,
production, use, storage, transport, clinical testing or sale of a
pharmaceutical product (including any Licensed Product), which may include the
authority to grant the required Pricing and Reimbursement Approvals for such
sale.

1.71“Regulatory Exclusivity” means any exclusive marketing rights or data
exclusivity rights conferred by any Regulatory Authority with respect to a
Licensed Product in a region, other than a Patent Right (potentially including
new clinical data exclusivity, orphan drug exclusivity, pediatric exclusivity,
or rights similar thereto), in each case, that confers exclusive rights to
BeiGene, its Affiliates or sublicensees, as applicable to Commercialize such
Licensed Product in such region.

1.72“Regulatory Submissions” means any filing, application or submission with
any Regulatory Authority, including authorizations, approvals or clearances
arising from the foregoing, including Regulatory Approvals and any Pricing and
Reimbursement Approvals, as applicable, and all correspondence or communication
with or from the relevant Regulatory

-13-

--------------------------------------------------------------------------------

Authority, as well as minutes of any material meetings, telephone conferences or
discussions with the relevant Regulatory Authority, in each case, with respect
to a Licensed Product.

1.73“[* * *]” means, with respect to a [* * *], to [* * *] the research,
development, manufacturing and commercialization activities relating to such
[* * *], [* * *] research, development and commercialization activities with
respect to Licensed Products under this Agreement, including by ensuring that:
(a) [* * *], as applicable, [* * *] or [* * *]; and (b) [* * *]; provided, that,
in either case of (a) or (b), [* * *], solely in connection with [* * *].

1.74“Territory” means China, Hong Kong, Taiwan, and Macau, with each considered
a “region” for purposes of this Agreement.

1.75“Territory Commercialization Plan” means, with respect to a Licensed
Product, the written strategic and tactical plan for the Commercialization of
such Licensed Product in the Field in the Territory to be prepared by BeiGene in
accordance with this Agreement, as such written plan may be amended, modified or
updated by BeiGene in accordance with Section 3.3(b).

1.76“Territory Only Case” means, with respect to each of (a) Licensed ABI-H0731
Product, (b) Licensed ABI-H2158 Product, and (c) Licensed ABI-H3733 Product, a
scenario where all registrational Clinical Trials for such Licensed ABI-H0731
Product, Licensed ABI-H2158 Product or Licensed ABI-H3733 Product (as
applicable) after the Effective Date for the purpose of obtaining the initial
Regulatory Approval in the Territory are conducted within the Territory. With
respect to the Licensed ABI-H0731 Product, the specific design of the Territory
Only Case is set forth in the ABI-H0731 Initial Development Plan, as may be
updated in accordance with Section 5.2(c).

1.77“[* * *]” means [* * *].

1.78“Third Party” means any Person other than a Party or an Affiliate of a
Party.

1.79“United States” or “US” means the United States of America and its
territories and possessions.

1.80“Upstream License” means that certain Exclusive License Agreement by and
between AssemblyBio and Indiana University Research and Technology Corporation
(“IURTC”), dated as of September 3, 2013, as may be amended.

1.81“USD” means United States dollars.

1.82“Valid Claim” means any claim of (a) an issued and unexpired patent or (b) a
pending patent application, in each case included within the AssemblyBio Patent
Rights; provided that such claim has not been abandoned, revoked or held
unenforceable, invalid or unpatentable by a court or other government body of
competent jurisdiction with no further possibility of appeal and which claim has
not been disclaimed, denied or admitted to be invalid or unenforceable through
reissue, re-examination or disclaimer or otherwise; provided that, if a pending
patent application has been pending for at least [* * *] years from its earliest
claimed priority date, then such corresponding claim in such pending patent
application will not be deemed to be a Valid Claim unless and until it
subsequently issues.

-14-

--------------------------------------------------------------------------------

1.83Additional Definitions. The following table identifies the location of
definitions set forth in various Sections of this Agreement:

 

Definition

Section

ABI-H0731 Initial Development Plan

5.2(c)

Accounting Firm

9.10(b)(i)

Agreement

Preamble

Agreement Payments

9.11(a)

Alliance Manager

3.1

Anti-Corruption Laws

12.7(a)(i)

Applicable Upstream License Provisions

2.8

AssemblyBio

Preamble

AssemblyBio Ancillary Trials Budget

5.5(c)

AssemblyBio Indemnitee(s)

13.1

AssemblyBio Publication

11.1(d)

AssemblyBio Veto Right

3.2(f)(i)

Audited Party

9.10(b)(i)

Auditing Party

9.10(b)(i)

BeiGene

Preamble

BeiGene Collaboration Patent Rights

14.3(a)

BeiGene Development Report

5.8

BeiGene Election

5.2(d)(ii)

BeiGene Indemnitees

13.2

BeiGene Publication

11.1(c)

BeiGene Veto Right

3.2(f)(ii)

Breach Notification

15.2(c)(i)

Claims

13.1

Clinical Supply Agreement

7.2(a)

Commercial Supply Agreement

7.2(b)

Commercialization Milestone Event

9.3

Commercialization Milestone Payment

9.3

Competing Product

2.6(a)

Confidentiality Agreement

16.15

Continuing Technology Transfer

4.1

Development Cost Cap

5.4(a)

Development Milestone Event

9.2

Development Milestone Payment

9.2

Disclosing Party

1.26

Dispute

16.6(a)

Effective Date

Preamble

-15-

--------------------------------------------------------------------------------

Enforceable Patent Rights

14.3(b)

Ex-Territory Infringement

14.3(a)

Excluded Claim

16.6(e)

Executive Officers

3.2(f)

Existing Regulatory Materials

12.2(o)

Expert

16.7(c)

Expert Dispute

16.7(a)

Expert Resolution Notice

16.7(b)

[* * *]

9.2

Global Brand Elements

8.4(c)

Global Development Budget

5.2(a)

Global Development Plan

5.2(a)

Global Publication Strategy

11.1(a)

ICH Guidelines

1.43

In-Licensed Patent Rights

2.8

Indemnified Party

13.3

Indemnifying Party

13.3

Initial Technology Transfer

4.1

Initiation

9.2

JAMS

16.6(a)

JCC

3.3(b)

JDC

3.3(a)

JGS Territory Extra Costs

5.4(c)

JGS Territory Extra Patients

5.4(c)

JMC

3.3(c)

Joint COGM Improvements

7.2(d)(i)

Joint Collaboration IP

14.1(a)

Joint Patent Rights

14.1(c)(ii)

JSC

3.2(a)

License

2.1

Losses

13.1

New Development Proposal

5.5(a)

Notice of Dispute

16.6(a)

Party/Parties

Preamble

Patient Enrollment Guardrail

5.2(b)

Pharmacovigilance Agreement

6.4

Product Infringement

14.3(a)

Product Marks

14.8

Public Official

12.7(d)

Publication

11.1(d)

-16-

--------------------------------------------------------------------------------

Receiving Party

1.26

Representatives

12.7(a)

[* * *]

[* * *]

Review Period

11.1(c)

Royalty Term

9.6(b)

Rules

16.6(a)

Scheduled Patent Rights

12.2(a)

SEC

11.4(c)

Securities Regulators

11.4(c)

Standstill Period

16.1

Subcommittees

3.3(d)

Taxes

9.11(a)

Technology Transfer

4.1

Term

15.1

Territory Clinical Trials

5.3(b)

Territory Development Budget

5.3(a)

Territory Development Plan

5.3(a)

Territory Only Case Budget

5.4(d)

Territory-Related Clinical Trials

5.3(b)

Territory-Specific Clinical Trials

5.3(b)

Third Party License

14.5

Unilateral Development Activity

5.5(b)

Upfront Payment

9.1

 

1.84Interpretation. The captions and headings to this Agreement are for
convenience only and are to be of no force or effect in construing or
interpreting any of the provisions of this Agreement. Unless specified to the
contrary, references to Articles, Sections or Exhibits mean the particular
Articles, Sections or Exhibits to this Agreement and references to this
Agreement include all Exhibits hereto.  In the event of any conflict between the
main body of this Agreement and any Exhibit hereto, the main body of this
Agreement shall prevail.  Unless context otherwise clearly requires, whenever
used in this Agreement: (a) the words “include” or “including” shall be
construed as incorporating, also, “but not limited to” or “without limitation”;
(b) the word “day” or “year” means a calendar day or year unless otherwise
specified; (c) the word “notice” shall mean notice in writing (whether or not
specifically stated) and shall include notices, consents, approvals and other
written communications contemplated under this Agreement; (d) the words
“hereof,” “herein,” “hereby” and derivative or similar words refer to this
Agreement as a whole and not merely to the particular provision in which such
words appear; (e)  the words “shall” and “will” have interchangeable meanings
for purposes of this Agreement; (f) the word “or” shall have the inclusive
meaning commonly associated with “and/or”; (g) provisions that require that a
Party, the Parties or a committee hereunder “agree,” “consent” or “approve” or
the like shall require that such agreement, consent or approval be specific and
in writing, whether by written agreement, letter, approved minutes or otherwise;
(h) words of any gender include the other gender; (i) words using the singular
or plural number also include the plural or singular number, respectively; (j)

-17-

--------------------------------------------------------------------------------

references to any specific law, rule or regulation, or article, section or other
division thereof, shall be deemed to include the then-current amendments thereto
or any replacement law, rule or regulation thereof; and (k) neither Party or its
Affiliates shall be deemed to be acting “under authority of” the other Party.

Article 2

LICENSE

2.1License Grant to BeiGene. Subject to the terms and conditions of this
Agreement and the terms and conditions of the Upstream License set forth on
Exhibit 2.1, AssemblyBio hereby grants to BeiGene an exclusive (subject to
AssemblyBio’s retained rights as set forth in Section 2.3), royalty-bearing
license, with the right to grant sublicenses solely in accordance with Section
2.2, under the AssemblyBio IP to (a) Develop and Commercialize Licensed Products
in the Field in the Territory, and (b) if applicable, to conduct any
Territory-Related Clinical Trials in accordance with Section 5.3(b) (the
“License”). For clarity, the License does not include any right for BeiGene to
Manufacture the Licensed Product, unless BeiGene takes on the Manufacturing of
the Licensed Product pursuant to Sections 7.2(d)(i) or 7.3.

2.2Right to Sublicense.

(a)Subject to the terms and conditions of this Agreement (including the
Applicable Upstream License Provisions and other terms and conditions of the
Upstream License as set forth in Exhibit 2.1), BeiGene shall have the right to
grant sublicenses under the License through multiple tiers: (i) to its
Affiliates, provided that such sublicense shall automatically terminate if such
sublicensee ceases to be an Affiliate of BeiGene; (ii) subject to Section 5.10,
to contract research organizations, distributors and other Third Party
subcontractors for the sole purpose of performing BeiGene’s obligations
hereunder, on BeiGene’s behalf, with respect to the Development and
Commercialization (or Manufacturing, in the event BeiGene takes on the
Manufacturing of the Licensed Product pursuant to Sections 7.2(d)(i) or 7.3) of
Licensed Products in the Field in the Territory, in each case as is set forth in
the Global Development Plan, Territory Development Plan or Territory
Commercialization Plan; and (iii) to any other Third Party with respect to the
Development and/or Commercialization of Licensed Products in the Field in the
Territory, subject to AssemblyBio’s prior written consent, not to be
unreasonably withheld, conditioned or delayed.  For purposes of clarity, BeiGene
shall have the right, in connection with the grant of a sublicense to any Third
Party pursuant to Section 2.2(a)(ii) or (iii), to transfer to such Third Party
such quantities of Licensed Compound as is reasonably necessary for such Third
Party to conduct Development and/or Commercialization activities in accordance
with the sublicense grant.

(b)Each sublicense shall be subject to a written agreement that is consistent
with the terms and conditions of this Agreement, and BeiGene shall ensure that
its sublicensees comply with the terms and conditions of this Agreement. BeiGene
shall include in each sublicense agreement an obligation of the applicable
sublicensee to cease all activities with respect to Licensed Products if BeiGene
terminates such sublicense agreement or if AssemblyBio terminates this
Agreement. BeiGene will remain directly responsible for all its obligations
under this Agreement, regardless of whether any such obligation is delegated or
sublicensed to any of its Affiliates or sublicensees. Any act or omission of a
sublicensee of BeiGene will be considered as an act or omission by BeiGene
hereunder. In the event of any material breach by any such

-18-

--------------------------------------------------------------------------------

sublicensee of any agreement entered into by BeiGene pursuant to Section 2.2(a)
that would be a material breach of this Agreement by BeiGene, BeiGene shall
[* * *].  BeiGene shall provide AssemblyBio with written notice of any proposed
sublicense (including the identity of the sublicensee, a summary of the
activities that are sublicensed and the region in which such rights have been
sublicensed) and, to the extent the sublicense agreement is executed pursuant to
Section 2.2(a)(iii), BeiGene shall provide AssemblyBio with a true and complete
copy of such sublicense agreement within [* * *] after it becomes effective,
subject to BeiGene’s right to redact any confidential or proprietary information
contained therein that is not necessary for AssemblyBio to determine compliance
with this Agreement, and if such agreement is not in English, a certified
translation into English thereof within [* * *] after the execution of such
sublicense agreement.  

2.3Retained Rights. Notwithstanding the exclusive nature of the License,
AssemblyBio expressly retains the rights to use the AssemblyBio IP in the Field
in the Territory in order to (a) perform its obligations under this Agreement,
(b) to conduct research and Development activities that are assigned to
AssemblyBio under the Global Development Plan or otherwise to the extent
expressly permitted by Sections 5.1(c), 5.5(b) and 5.5(c) of this Agreement, (c)
to Develop the Licensed Products in the Territory to support the Development or
Commercialization outside of the Territory (only to the extent such Development
would not reasonably be expected to materially adversely impact BeiGene’s
Development or Commercialization activities of the Licensed Products in the
Field in the Territory under this Agreement), and (d) to Manufacture Licensed
Product in the Territory, in each case whether directly or through its
Affiliates, licensees or contractors. For clarity, AssemblyBio retains the
exclusive right to practice, license and otherwise exploit the AssemblyBio IP
outside the scope of the License.

2.4License Grants to AssemblyBio.  Subject to the terms and conditions of this
Agreement, BeiGene hereby grants to AssemblyBio a non-exclusive, fully-paid,
royalty-free (except as set forth in Section 15.3(b)), perpetual, irrevocable,
and sublicensable (through multiple tiers) license under the BeiGene IP, BeiGene
Collaboration IP and BeiGene’s interest in the Joint Collaboration IP solely (a)
to Develop, Manufacture, and Commercialize Licensed Products outside the
Territory and (b) to conduct any activities within AssemblyBio’s retained rights
set forth under Section 2.3 in the Territory.

2.5No Implied Licenses; Negative Covenant.  Except as expressly set forth
herein, neither Party shall acquire any license or other intellectual property
interest, by implication or otherwise, under any trademarks, Patent Rights or
patent applications of the other Party. BeiGene shall not, and shall not permit
any of its Affiliates or sublicensees to, practice any AssemblyBio IP outside
the scope of the License.

2.6Non-Compete.

(a)Non-Compete Obligations of BeiGene. Subject to Section 2.7 and except as
otherwise agreed by the Parties, during the Term, BeiGene shall not [* * *]
Commercialize any pharmaceutical product that [* * *] (each a “Competing
Product”) in the Territory, other than Licensed Products in accordance with this
Agreement.

(b)Non-Compete Obligations of AssemblyBio. Subject to Section 2.7 and except as
otherwise agreed by the Parties, during the Term, AssemblyBio shall not [* * *]

-19-

--------------------------------------------------------------------------------

Commercialize any Competing Products in the Territory, other than Licensed
Products in accordance with this Agreement.

2.7[* * *]. Notwithstanding Section 2.6, if at any time during the Term:

(a)a Party or any of its Affiliates [* * *] through the acquisition of a Third
Party (whether by merger or acquisition of all or substantially all of the stock
or assets of a Third Party or of any operating or business division of a Third
Party or similar transaction), such acquisition, and the [* * *] thereafter,
shall not constitute a breach of [* * *] if such Party or such Affiliate, as
applicable, (i) [* * *] such [* * *] within [* * *] of closing of the
acquisition and, at all times prior to such [* * *], [* * *] such [* * *], or
(ii) with the consent of the other Party, agrees to [* * *]; or

(b)a Third Party that is (at the time of such acquisition) [* * *] acquires a
Party (whether by merger or acquisition of all or substantially all of the stock
or of all or substantially all of the assets of such Party or of any operating
or business division of such Party or similar transaction), such acquisition,
and the [* * *] by such relevant acquiring Third Party, as the case may be, or
any of its Affiliates, shall not constitute a breach of [* * *]; provided that
(i) such acquiring Third Party at all times [* * *] and (ii) to the extent that
AssemblyBio is the Party being acquired, then [* * *], solely to the extent
reasonably necessary to (x) [* * *] or (y) [* * *]; provided that, in each case
(x) and (y), [* * *].

2.8Upstream License.  BeiGene acknowledges and agrees that (a) AssemblyBio
obtained the rights to certain AssemblyBio Patent Rights under the Upstream
License (the “In-Licensed Patent Rights”); and (b) the License granted by
AssemblyBio to BeiGene under Section 2.1 with respect to such In-Licensed Patent
Rights constitutes a sublicense under the Upstream License.  BeiGene shall
comply with the terms and conditions of the Upstream License set forth in
Exhibit 2.8 (the “Applicable Upstream License Provisions”). The Applicable
Upstream License Provisions and other terms and conditions of the Upstream
License as set forth in Exhibit 2.1 and Exhibit 14.6 shall be considered an
integral part of the terms and conditions of this Agreement.

Article 3

GOVERNANCE

3.1Alliance Managers. Each Party shall appoint an individual, who is an employee
of such Party, to act as its alliance manager under this Agreement [* * *] after
the Effective Date (the “Alliance Manager”). The Alliance Managers shall: (a)
serve as the primary points of contact between the Parties for the purpose of
providing the other Party with information on the progress of a Party’s
activities under this Agreement; (b) be responsible for facilitating the flow of
information and otherwise promoting communication, coordination and
collaboration between the Parties, provided that all communications between the
Parties shall be in English; (c) facilitate the prompt resolution of any
disputes; and (d) attend JSC (as a non-voting participant), JDC, JMC, JCC and
other Subcommittee meetings. An Alliance Manager may also bring any matter to
the attention of the JSC, JDC, JMC, JCC or any other Subcommittee if such
Alliance Manager reasonably believes that such matter warrants such attention.
Each Party may replace its Alliance Manager at any time upon written notice to
the other Party.

-20-

--------------------------------------------------------------------------------

3.2Joint Steering Committee.

(a)Formation. No later than [* * *] following the Effective Date, the Parties
shall establish a joint steering committee (the “JSC”) to (i) monitor and
coordinate the Development, Manufacture and Commercialization of Licensed
Products in the Field in the Territory and the Development and Manufacture of
Licensed Products pursuant to the Global Development Plan outside of the
Territory and (ii) provide a forum for AssemblyBio to provide updates with
respect to the Commercialization of Licensed Products outside of the Territory
to the extent necessary and useful for BeiGene in its Commercialization of
Licensed Products in the Field in the Territory.  The JSC will be composed of an
equal number of representatives from each Party and a minimum of three (3)
representatives of each Party, with (x) at least two (2) representatives of each
Party that have direct knowledge and expertise in the development, manufacture
and commercialization of biopharmaceutical products, and (y) at least one
representative of each Party holding the position of vice president or above in
such Party. Each representative to the JSC shall be an employee of the
applicable Party, unless otherwise agreed by both Parties.

(b)Role. The JSC shall:

(i)set the strategic direction of, and encourage and facilitate ongoing
communication between the Parties with respect to, the Development, Manufacture
and Commercialization of Licensed Products;

(ii)provide a forum for the discussion of the Parties’ activities under this
Agreement;

(iii)review and discuss the overall strategy for the Development, Manufacture,
and Commercialization of Licensed Products in the Field in the Territory;

(iv)establish and oversee the JDC, JCC, JMC and other Subcommittees as necessary
or advisable to further the purpose of this Agreement, and review, discuss and
try to resolve any unresolved disputes from the JDC, JCC, JMC and other
Subcommittees;

(v)review and discuss any updates provided by AssemblyBio regarding AssemblyBio
Know-How pursuant to Section 4.1;

(vi)review and discuss each BeiGene Development Report, the status, progress and
results of Development activities of the Licensed Products and the related costs
pursuant to Section 5.8;

(vii)review and discuss any potential harmful actions brought to its attention
by either Party pursuant to Section 6.6;

(viii)review and discuss any Commercialization report submitted by BeiGene
pursuant to Section 8.3;

-21-

--------------------------------------------------------------------------------

(ix)review, discuss and adopt the Global Publication Strategy and any amendments
thereto pursuant to Section 11.1(a); and

(x)perform such other functions as expressly set forth in this Agreement or
allocated to the JSC by the Parties’ written agreement.

(c)Limitation of Authority. The JSC shall only have the powers expressly
assigned to it in this Article 3 and elsewhere in this Agreement and shall not
have the authority to: (i) modify or amend the terms and conditions of this
Agreement; (ii) waive either Party’s compliance with the terms and conditions of
this Agreement; or (iii) determine any issue in a manner that would conflict
with the express terms and conditions of this Agreement.

(d)Meetings. The JSC shall hold meetings at such times as it elects to do so,
but shall meet no less frequently than [* * *] per Calendar Year. In addition,
special meetings of the JSC may be convened by either Alliance Manager upon not
less than [* * *] (or, if such meeting is proposed to be conducted by
teleconference, as soon as reasonably practicable) written notice to the other
Alliance Manager. The JSC may meet in person or by means of teleconference,
Internet conference, videoconference or other similar communication method, or
(no more than [* * *]) in person at locations selected alternatively by
AssemblyBio and BeiGene or such other location as the Parties may agree. Each
Party shall bear its own expenses related to participation in and attendance at
such meetings by its respective JSC representatives. The Alliance Managers shall
jointly prepare and circulate minutes for each JSC meeting within [* * *] of
each such meeting and shall ensure that such minutes are reviewed and approved
by their respective companies within [* * *] thereafter.  Communications between
the Parties pursuant to the JSC meetings shall be in English.

(e)Non-Member Attendance. Each Party may from time to time invite a reasonable
number of participants, in addition to its representatives, to attend a meeting
of the JSC (in a non-voting capacity), JDC, JCC, JMC or other Subcommittee in
the event that the planned agenda for such JSC, JDC, JCC, JMC or Subcommittee
meeting would require such participants’ expertise; provided that if either
Party intends to have any Third Party (including any consultant) attend such a
meeting, such Party shall provide prior written notice to the other Party, shall
obtain approval from such other Party for such Third Party to attend (such
approval not to be unreasonably withheld, conditioned or delayed), and shall
ensure that such Third Party is bound by confidentiality and non-use obligations
consistent with the terms of this Agreement.

(f)Decision-Making. All decisions of the JSC shall be made by consensus, with
each Party’s representatives having, collectively, one vote. If after reasonable
discussion and good faith consideration of each Party’s view on a particular
matter before the JSC, the JSC cannot reach consensus as to such matter within
[* * *] after such matter was brought to the JSC for resolution, such matter
shall be referred to the Chief Executive Officer of AssemblyBio (or an executive
officer of AssemblyBio designated by the Chief Executive Officer of AssemblyBio
who has the power and authority to resolve such matter) and the Chief Executive
Officer of BeiGene (or an executive officer of BeiGene designated by the Chief
Executive Officer of BeiGene who has the power and authority to resolve such
matter) (collectively, the “Executive Officers”) for

-22-

--------------------------------------------------------------------------------

resolution. If the Executive Officers cannot resolve such matter within [* * *]
after such matter has been referred to them, then:

(i)BeiGene Final Decision-Making Authority. Subject to Section 3.2(f)(ii),
BeiGene shall have the final decision-making authority for matters within the
scope of the JSC’s decision-making authority with respect to (A) any [* * *] for
Licensed Products solely in the Field in the Territory [* * *], including
[* * *], (B) all [* * *], including approval of the [* * *], and, with respect
to Licensed Products, further including [* * *], in each case solely in the
Field in the Territory, and (C) all [* * *] leading up to and including the
[* * *], solely for Licensed Products in the Field from Regulatory Authorities
in the Territory; provided that BeiGene shall not exercise its final decision
making authority to take any action that would be reasonably expected to (x)
[* * *], or (y) [* * *], in both cases (x) and (y), without AssemblyBio’s prior
consent (such consent not to be unreasonably withheld, conditioned or delayed)
(AssemblyBio’s right to veto matters set forth under clauses (x) and (y),
“AssemblyBio Veto Rights”).

(ii)AssemblyBio Final Decision-Making Authority. Subject to Section 3.2(f)(i),
AssemblyBio shall have the final decision-making authority for matters within
the scope of the JSC’s decision-making authority with respect to (A) whether the
Parties will [* * *] for the Licensed Products, (B) any [* * *], including any
[* * *], (C) the approval of the [* * *] and any updates thereto, (D) the
approval of [* * *] or any updates thereto, and (E) any [* * *] matters of the
Licensed Compounds and Licensed Products, except for [* * *]; provided that,
AssemblyBio shall not exercise its final decision-making authority in a manner
that would be reasonably expected to: (x) [* * *], or (y) [* * *], in both cases
(x) and (y), without BeiGene’s prior consent (such consent not to be
unreasonably withheld, conditioned or delayed) (BeiGene’s right to veto matters
set forth under clauses (x) and (y), “BeiGene Veto Rights”). For clarity,
AssemblyBio retains sole discretion and final decision-making authority with
respect to (1) any Development or Commercialization activities in relation to
the Licensed Compounds and Licensed Products outside of the Territory, and (2)
the Development of all Licensed Products before the Initiation of Phase 3
Clinical Trial thereof, including such Development activities in the Territory
pursuant to Section 5.1(c). Notwithstanding the foregoing, as AssemblyBio
exercises its sole discretion and final decision-making authority with respect
to any Development or Commercialization activities in relation to the Licensed
Compounds and Licensed Products outside of the Territory, if [* * *], then
[* * *].

(iii)No Change; Status Quo. Neither Party shall have final decision making
authority with respect to: (A) the number of patients to be enrolled in the
Territory for any Joint Global Study in excess of [* * *] of the worldwide
patients to be enrolled pursuant to Section 5.2(b), subject to the Patient
Enrollment Guardrail thereunder; (B) whether to approve any Global Development
Budget or Territory Development Budget for the Licensed ABI-H0731 Products
pursuant to Section 5.2(c) that [* * *]; (C) any approval of a New Development
Proposal under Section 5.5(a); (D) any Joint COGM Improvements (which shall
require amendment of this Agreement); (E) the transfer of some or all
Manufacturing responsibilities of Licensed Compounds and Licensed Products in
the Territory to BeiGene pursuant to Section 7.2(d)(i); and (F) whether [* * *].
All matters set forth in the foregoing clauses ((A) through (F)) must be decided
by unanimous agreement of the Parties in order to take any action or adopt any
change from the then-current status quo.

-23-

--------------------------------------------------------------------------------

3.3Sub-Committees.

(a)Joint Development Committee. Within [* * *] after the Effective Date, the
Parties shall establish a joint development committee (the “JDC”) to (i) review,
discuss, coordinate and share information regarding the Development of Licensed
Products in the Territory or outside the Territory pursuant to the Global
Development Plan; (ii) review, discuss, and share information regarding the
Development of Licensed Products outside of the Territory; (iii) review,
discuss, coordinate and share information regarding the progress of the
Regulatory Approvals and Regulatory Submissions for Licensed Products in the
Territory; (iv) review, discuss and approve the Territory Development Plan and
Global Development Plan and any amendments thereto; (v) agree to the proportion
of patients in any Joint Global Study to be included from the Territory pursuant
to Section 5.2(b); (vi) review, discuss and determine the path forward for the
joint Development of the Licensed ABI-H2158 Products and Licensed ABI-H3733
Products under Section 5.2(d), (vii) coordinate regarding the reimbursement of
the JGS Territory Extra Costs under Section 5.4(c); (viii) review, discuss and
determine whether to approve any New Development Proposal pursuant to Section
5.5(a); (ix) review updates regarding Clinical Trials conducted pursuant to the
Global Development Plan or the Territory Development Plan pursuant to Section
6.2; and (x) perform such other functions as expressly set forth in this
Agreement or allocated to the JDC by the Parties’ written agreement.

(b)Joint Commercialization Committee. Not later than [* * *] prior to the
anticipated date of the filing of the first application for Regulatory Approval
for a Licensed Product in the Territory, the Parties shall establish a joint
commercialization committee (the “JCC”) to: (i) review, discuss, coordinate,
share information regarding, and approve the Global Commercialization Principles
and the Territory Commercialization Plan and amendments thereto; (ii) review,
discuss, coordinate, and share information regarding the progress of the
Commercialization of Licensed Products in the Territory; (iii) review, discuss,
coordinate, and share information regarding commercial issues relevant to the
Commercialization of Licensed Products in the Territory and AssemblyBio’s
Commercialization of Licensed Products outside of the Territory and global
harmonization of such activities; (iv) review and discuss any Commercialization
report submitted by BeiGene pursuant to Section 8.3; (v) review and discuss any
pricing matters of the Licensed Products in and outside of the Territory
pursuant to Section 8.4(b); (vi) review and discuss the branding strategy for
the Licensed Products in the Territory pursuant to Section 8.4(c); and (vii)
perform such other functions as expressly set forth in this Agreement or
allocated to the JCC by the Parties’ written agreement.

(c)Joint Manufacturing Committees. Not later than [* * *] after the Effective
Date, the Parties shall establish a joint manufacturing committee (the “JMC”)
to: (i) review and discuss Manufacturing of Licensed Compounds and Licensed
Products, including the Fully Burdened Manufacturing Cost; (ii) review, discuss
and approve any Joint COGM Improvements pursuant to Section 7.2(d); (iii) review
and discuss potential transfer of Manufacturing activities to the Territory
pursuant to Section 7.3 (provided, that such transfer shall require the approval
of the Parties, rather than the JMC, pursuant to Section 7.3); and (iv) perform
such other functions as expressly set forth in this Agreement or allocated to
the JMC by the Parties’ written agreement.

(d)Subcommittees and Working Groups. The JSC may create, when advisable, other
subcommittees or working groups (such as, for example, a joint project team in
charge of day-to-day communication and operation of the Development activities
in the Territory),

-24-

--------------------------------------------------------------------------------

comprised of representatives of each Party having qualifications and experience
relevant to a productive dialogue on the subject matter of each such
subcommittee (collectively with the JDC, JCC and JMC, the “Subcommittees”).

(e)Subcommittee Representatives. Each Party shall appoint two (2)
representatives to each Subcommittee, each of whom is an officer or employee of
the applicable Party having sufficient knowledge regarding the topics within the
jurisdiction of such Subcommittee with respect to the Territory.

(f)Subcommittee Meetings. The Subcommittees will meet with the frequency and in
the manner (in person or otherwise) of the JSC or such other frequency or manner
as the JSC shall determine.  

(g)Subcommittee Decision Making. Each Subcommittee and its activities shall be
subject to the oversight of, and shall report to, the JSC, and the JSC shall
resolve all disputes that arise within the Subcommittee within [* * *] after any
such matter is brought to the JSC for resolution, except regarding the JDC’s
decision on the path forward for the joint Development of the Licensed ABI-H2158
Products and Licensed ABI-H3733 Products under Section 5.2(d)(i), which shall be
referred to the Executive Officers of the Parties for resolution directly if JDC
is unable to reach an agreement pursuant to Section 5.2(d). In no event shall
the authority of the Subcommittees exceed the authority of the JSC. Each Party
shall be responsible for all of its own expenses of participating in the
Subcommittees.

3.4Discontinuation of JSC and Subcommittees. The JSC shall continue to exist
until the Parties mutually agree to disband the JSC. Once the JSC is disbanded,
the JSC shall have no further obligations under this Agreement and, thereafter,
the Alliance Managers shall be the points of contact for the exchange of
information under this Agreement and decisions of the JSC shall be decisions
between the Parties, subject to the other terms and conditions of this
Agreement.  The Subcommittees shall disband upon the disbandment of the JSC or
earlier, as determined by the JSC.

Article 4

TECHNOLOGY TRANSFER

4.1Technology Transfer.  Within [* * *] after the Effective Date, AssemblyBio
will provide and transfer to BeiGene [* * *] the AssemblyBio Know-How that
exists on the Effective Date and was not previously provided to BeiGene by
providing copies or samples of relevant documentation, materials and other
embodiments of such AssemblyBio Know-How, including data within reports, and
electronic files, that exist on the Effective Date (the “Initial Technology
Transfer”). Thereafter, during the Term, AssemblyBio shall (a) at each meeting
of the JSC (and, in any event, on [* * *] if any JSC meeting is not held in a
particular [* * *]), provide BeiGene with a summary of additional AssemblyBio
Know-How, if any, developed since the last meeting of the JSC, (b) transfer any
such AssemblyBio Know-How to BeiGene promptly following BeiGene’s reasonable
request, and (c) provide BeiGene with reasonable access to AssemblyBio personnel
involved in the research and Development of Licensed Products, either in-person
at AssemblyBio’s facility or by teleconference (the “Continuing Technology
Transfer,” and together with the Initial Technology Transfer, the “Technology
Transfer”).  For the avoidance of doubt, AssemblyBio’s personnel shall not be
obligated to travel to BeiGene’s facilities, and

-25-

--------------------------------------------------------------------------------

AssemblyBio’s transfer obligations under this Section 4.1 shall apply solely to
the extent the AssemblyBio Know-How is reasonably necessary to support BeiGene’s
Development and Commercialization of a Licensed Product in the Field in the
Territory in accordance with this Agreement.

Article 5

DEVELOPMENT PROGRAM

5.1Diligence and Responsibilities.

(a)BeiGene shall be responsible for the Development of the Licensed Products in
the Field in the Territory in accordance with this Article 5.  BeiGene shall use
Commercially Reasonable Efforts to (i) Develop Licensed Products in the Field in
the Territory in accordance with the Territory Development Plan and the Global
Development Plan, and (ii) obtain Regulatory Approval and Pricing and
Reimbursement Approval for Licensed Products in the Field in the Territory in
accordance with the Territory Development Plan. BeiGene shall conduct such tasks
in a timely, professional manner and in compliance with the Territory
Development Plan and Global Development Plan, as applicable, and all Applicable
Laws, including GLP, GCP and cGMP.

(b)AssemblyBio shall be responsible for the Development of the Licensed Products
outside of the Territory. AssemblyBio shall use Commercially Reasonable Efforts
to conduct the research and Development activities in or for the Territory that
are assigned to AssemblyBio under the Global Development Plan. In addition,
AssemblyBio may conduct research and Development activities in the Territory (i)
to the extent permitted by Sections 5.1(c), 5.5(b) and 5.5(c) of this Agreement,
or (ii) to support the Development or Commercialization outside of the Territory
(to the extent such Development by AssemblyBio in the Territory would not
[* * *]).

(c)Unless the Parties otherwise agree, AssemblyBio will have operational control
over the Development of each Licensed Product before the Initiation of Phase 3
Clinical Trial for such Licensed Product, including such Development activities
in the Territory, and shall be solely responsible for all costs and expenses of
all such Development activities. For clarity, any phase 1 or phase 2 Clinical
Trials for a Licensed Product conducted concurrently with or after the
Initiation of a Phase 3 Clinical Trial for such Licensed Product will remain
subject to the foregoing provision in this Section 5.1(c) after the Initiation
of Phase 3 Clinical Trial of such Licensed Product.  

5.2Global Development Activities.

(a)Global Development Plan. With respect to each of Licensed ABI-H0731 Products,
Licensed ABI-H2158 Products and Licensed ABI-H3733 Products, the Parties will
discuss and decide through the JDC whether to jointly conduct global Development
activities for such Licensed Products (including a Joint Global Study) that
include Clinical Trial sites in the Territory, taking into account the feedback
from the Regulatory Authorities in and outside the Territory, and with respect
to Licensed ABI-H2158 Products and Licensed ABI-H3733 Products, subject to
Section 5.2(d). If the Parties disagree regarding the foregoing, [* * *]
regarding whether the Parties shall jointly conduct global Development
activities for such Licensed Products (including a Joint Global Study), provided
that the proposed Development activities to be

-26-

--------------------------------------------------------------------------------

conducted in the Territory and the related study protocols are [* * *]. If the
Parties agree to conduct any such joint global Development activities (including
any Joint Global Study) or if [* * *] (subject to BeiGene Election under Section
5.2(d)(ii)), the Parties, through the JDC, will agree to a global clinical
Development plan for such joint global Development activities, including a
Clinical Trial protocol for any Joint Global Study (the “Global Development
Plan” and, until the Global Development Plan is approved pursuant to this
Section 5.2(a), all references in this Agreement to the Global Development Plan
shall be deemed references to the ABI-H0731 Initial Development Plan). The
Global Development Plan shall include (i) an outline of all such global
Development activities (including all Clinical Trials) for Licensed Products to
be conducted by either Party, (ii) details and timelines of the Development
activities in the Territory assigned to BeiGene as part of a Joint Global Study
(including the number of patients to be enrolled in the Territory for such Joint
Global Study), (iii) unless otherwise agreed to by the Parties, the details and
timelines of any other Development activities (including Clinical Trials) in the
Territory assigned to BeiGene to support global Development of the Licensed
Product, and (iv) a proposed budget for the Joint Global Study and other global
Development activities set forth under the Global Development Plan (including
any Costs incurred related to any start-up activities for any Phase 3 Clinical
Trial) (the “Global Development Budget”). AssemblyBio will propose the initial
draft of the Global Development Plan and submit to the JDC for its review,
discussion and, solely with respect to the portion of the Global Development
Plan that relates to the Territory or activities assigned to BeiGene, approval.
From time to time, AssemblyBio may make and implement amendments to the
then-current Global Development Plan, and may propose amendments to the Global
Development Plan to include the other Licensed Compounds. To the extent such
amendments relate to the Territory or activities assigned to BeiGene,
AssemblyBio shall submit such proposed amendments to the JDC for review,
discussion and approval.  AssemblyBio shall [* * *] any comments provided by
BeiGene with respect to the Global Development Plan and any amendments thereto
to the extent related to the Territory or activities assigned to BeiGene.  In
[* * *] in relation to whether to conduct a Joint Global Study and designing
study protocols under the Global Development Plan, AssemblyBio shall reasonably
take into account [* * *].

(b)Joint Global Study Patient Enrollment. The portion of patients to be enrolled
in the Territory for each Joint Global Study shall be mutually agreed to by the
Parties and set forth in the applicable Global Development Plan (and in no event
shall be less than [* * *] of all patients to be enrolled worldwide, unless the
Parties otherwise agree), which allocation will be determined in a manner to
maximize the speed and chance of success for such Joint Global Study. BeiGene
will be responsible for the recruitment and enrollment of all patients in the
Territory and the conduct of the portion of the Clinical Trial in the Territory
that constitutes part of the Joint Global Study.  Notwithstanding [* * *], in
the event that AssemblyBio’s proposed portion of patients allocated to the
Territory for any Joint Global Study exceeds [* * *] of all patients to be
enrolled worldwide, BeiGene has the right to veto such allocation above [* * *]
of worldwide patients if, [* * *], in which case the Parties will discuss in
good faith through the JDC and agree on any portion of patients above [* * *] of
worldwide patients to be enrolled in the Territory by BeiGene for such Joint
Global Study, and in the event the Parties cannot reach an agreement, the number
of patients to be enrolled in the Territory shall be [* * *] of all patients to
be enrolled worldwide (the “Patient Enrollment Guardrail”).

-27-

--------------------------------------------------------------------------------

(c)ABI-H0731 Initial Development Plan. The initial Development Plan for the
Licensed ABI-H0731 Products is attached hereto as Exhibit 5.2(c) (the “ABI-H0731
Initial Development Plan”). The ABI-H0731 Initial Development Plan sets forth,
among other things, [* * *]. Any global Development activities (including any
Joint Global Study) in the ABI-H0731 Initial Development Plan shall be updated
by the Parties pursuant to the process described in Section 5.2(a), and any
Territory-specific Development activities in the ABI-H0731 Initial Development
Plan will be updated pursuant to the process described in Section 5.3(a). The
Global Development Budget and Territory Development Budget, as applicable, for
the Licensed ABI-H0731 Products shall not [* * *], unless such Phase 3 Clinical
Trial design is modified as contemplated by this Section 5.2(c) (i) [* * *],
(ii) [* * *], or (iii) as otherwise agreed by the Parties.

(d)Joint Development of Licensed ABI-H2158 Products and Licensed ABI-H3733
Products.

(i)Selection of Development Plan. For each of Licensed ABI-H2158 Products and
Licensed ABI-H3733 Products, promptly after the first end-of-phase 2 (EOP2)
meeting between AssemblyBio and the applicable Regulatory Authority, the Parties
shall discuss through the JDC the path forward for the joint Development of the
Licensed ABI-H2158 Products or Licensed ABI-H3733 Products (as applicable), and
shall discuss (A) whether to conduct a Territory-only Phase 3 Clinical Trial for
such Licensed Products, including the study design, protocol, the number of
patients to be enrolled for such Phase 3 Clinical Trial, and the related budget
for such Development activities; and (B) (x) whether the Territory will be part
of the Joint Global Study, and (y) if the Territory will be part of the Joint
Global Study, the study design and protocol for the Territory-portion of such
Joint Global Study, the number of patients to be enrolled for such Joint Global
Study in the Territory (pursuant to Section 5.2(b)), and the related budget for
such Development activities. If the JDC decides to move forward with the
Territory-only Phase 3 Clinical Trial for such Licensed Products, such
Development activities will be governed by a Territory Development Plan pursuant
to Section 5.3(a) and subject to the cost sharing arrangement under Section 5.4.
If the JDC decides to move forward with a Joint Global Study, such Development
activities will be governed by a Global Development Plan pursuant to Section
5.2(a) and the Territory-portion of such Joint Global Study shall be subject to
the cost sharing arrangement under Section 5.4. If the JDC cannot reach an
agreement regarding the path forward for the joint Development of the Licensed
ABI-H2158 Products or Licensed ABI-H3733 Products (as applicable) within [* * *]
following the first EOP2 meeting between AssemblyBio and the applicable
Regulatory Authority, such matter shall be referred to the Executive Officers of
both Parties for resolution. All discussion between the Parties under this
Section 5.2(d)(i) shall be conducted and all decisions related thereto shall be
made in good faith. For clarity, AssemblyBio shall retain operational control
and full discretion over any Development activities outside of the Territory
(including any global study that does not include the Territory or any portion
of a Joint Global Study that is outside of the Territory).

(ii)BeiGene’s Election. If the Executive Officers of the Parties cannot agree
upon a path forward for the joint Development of the Licensed ABI-H2158 Products
or Licensed ABI-H3733 Products (as applicable) within [* * *] after such matter
is referred to them pursuant to Section 5.2(d)(i), AssemblyBio shall have the
final decision-making authority regarding such matter (which authority shall not
be subject to BeiGene Veto Rights under Section 3.2(f)(ii)). If AssemblyBio
decides to move forward with a Joint Global Study for such Licensed Products
with patient enrollment in the Territory pursuant to Section 5.2(b), then
BeiGene shall

-28-

--------------------------------------------------------------------------------

have the option to, solely with respect to the Licensed ABI-H2158 Products or
Licensed ABI-H3733 Products (as applicable): (A) conduct the Territory-portion
of the Joint Global Study as proposed by AssemblyBio, or (B) terminate this
Agreement with respect to the Licensed ABI-H2158 Products or Licensed ABI-H3733
Products (as applicable) immediately upon written notice to AssemblyBio (the
election to terminate pursuant to this clause (B), the “BeiGene Election”). In
the event BeiGene elects to conduct the Territory-portion of the Joint Global
Study, the Parties will continue to collaborate on such Development activities
pursuant to a Global Development Plan for the applicable Licensed Products in
accordance with Section 5.2(a) and Section 5.2(b) and the Territory-portion of
the Joint Global Study shall be subject to the cost sharing arrangement under
Section 5.4. In the event BeiGene elects to exercise BeiGene Election, (1) this
Agreement will be deemed terminated immediately with respect to the Licensed
ABI-H2158 Products or Licensed ABI-H3733 Products (as applicable) upon written
notice of such election by BeiGene to AssemblyBio, which notice shall be
provided within [* * *] after the expiration of the foregoing [* * *] period;
(2) BeiGene shall [* * *]; (3) ABI-H2158 or ABI-H3733 (as applicable) and such
Licensed Compound’s corresponding Licensed Products will cease to be a Licensed
Compound, Listed Compound and Licensed Products under this Agreement, and,
except as set forth under clause (4) below, will no longer be subject to terms
and conditions of this Agreement (including the non-compete obligations under
Section 2.6 and the payment obligations under Article 9); (4) Section 15.3 shall
apply to ABI-H2158 or ABI-H3733 (as applicable) and such Licensed Compound’s
Licensed Products (to the extent applicable, except that, for clarity, such
Licensed Products shall not be subject to [* * *] under Section 15.3(b)); and
(5) BeiGene shall have no further rights or obligations related to ABI-H2158 or
ABI-H3733 (as applicable) and such Licensed Compound’s corresponding Licensed
Products, and Exhibit 12.2(a) will be deemed to be updated to exclude the
AssemblyBio Patent Rights that are solely related thereto. For clarity, in the
event AssemblyBio decides to move forward with a Joint Global Study for the
Licensed ABI-H2158 Products or Licensed ABI-H3733 Products (as applicable),
BeiGene shall no longer have the option to instead conduct a Territory-only
Phase 3 Clinical Trial for such Licensed Products but shall have the right to
make the BeiGene Election.

5.3Territory Development Activities.

(a)Territory Development Plan. Except for the activities allocated to BeiGene
under the Global Development Plan pursuant to Section 5.2, all Development of
Licensed Products in the Territory under this Agreement shall be conducted by
BeiGene pursuant to a written development plan (as amended from time to time in
accordance with this Section 5.3 and Section 3.3(a), the “Territory Development
Plan” and, until the Territory Development Plan is approved pursuant to this
Section 5.3(a), all references in this Agreement to the Territory Development
Plan shall be deemed references to the ABI-H0731 Initial Development Plan). The
Territory Development Plan shall include a proposed budget for the Development
activities (including the Territory Clinical Trials) set forth under the
Territory Development Plan (including any Costs incurred related to any start-up
activities for any Phase 3 Clinical Trial) (the “Territory Development Budget”).
AssemblyBio will propose the initial draft of the Territory Development Plan for
the Licensed ABI-H2158 Products and Licensed ABI-H3733 Products and submit to
the JDC for its review, discussion and approval. From time to time after the
Effective Date, but not less than annually, either Party may propose amendments
to the Territory Development Plan and submit such proposed updated or amended
Territory Development Plan to the JDC for review, discussion and approval. Once
approved by the JDC, the amended Territory Development Plan

-29-

--------------------------------------------------------------------------------

shall become effective. For clarity, the Territory Development Plan and
amendments thereto shall be consistent with the Global Development Plan, and the
Global Development Plan shall take precedence in case of any conflict or
inconsistency between the Territory Development Plan and the Global Development
Plan.

(b)Territory Clinical Trials. In accordance with the Territory Development Plan,
BeiGene shall be responsible for and be the sponsor of (i) all Clinical Trials
in the Territory that are not part of the Joint Global Study nor part of
AssemblyBio’s retained right under Section 2.3 to conduct Development activities
with respect to the Licensed Products (the “Territory-Specific Clinical
Trials”), and (ii) all Clinical Trials in other Asian countries outside of the
Territory that are required by Regulatory Authorities in the Territory (the
“Territory-Related Clinical Trials,” together with the Territory-Specific
Clinical Trials, the “Territory Clinical Trials”). The Development and
Regulatory Costs incurred by BeiGene for the Territory-Specific Clinical Trials
will count towards the Development Cost Cap and be subject to Section 5.4.
[* * *] of the Development and Regulatory Costs incurred by BeiGene for
Development activities for countries outside of the Territory in relation to the
Territory-Related Clinical Trials.

5.4Development Costs Sharing.

(a)Development Cost Cap. BeiGene will be responsible for all Development and
Regulatory Costs for the Development activities with respect to the Licensed
Products in and for the Territory contemplated by the Global Development Plan
and Global Development Budget or the Territory Development Plan and Territory
Development Budget, as applicable, after the Effective Date (including the
portion of Joint Global Studies being conducted in the Territory), up to an
aggregate maximum of USD forty-five million ($45,000,000) (the “Development Cost
Cap”).  For clarity, except as provided under Section 5.5(c), costs and expenses
incurred by AssemblyBio outside of the Territory are not within BeiGene’s
responsibility.

(b)Development Costs Sharing Over Cap. After BeiGene’s total expenditure on
Development and Regulatory Costs for the Territory reaches the Development Cost
Cap, BeiGene and AssemblyBio will share all Development and Regulatory Costs
incurred by both Parties in relation to Licensed Products in and for the
Territory (including the portion of Joint Global Studies being conducted for
Licensed Products in the Territory) in excess of the Development Cost Cap for
the Licensed Products equally (50:50), exclusive of any JGS Territory Extra
Costs (as defined below) incurred by BeiGene, which shall be reimbursed by
AssemblyBio in accordance with Section 5.4(c).  For clarity, except as provided
under Section 5.5(c), BeiGene shall not share in any costs and expenses of
AssemblyBio outside of the Territory pursuant to this Section 5.4.

(c)JGS Territory Extra Costs. If the actual portion of patients enrolled in the
Territory by BeiGene for a Joint Global Study exceeds [* * *] of all patients
enrolled worldwide, AssemblyBio shall reimburse the Development and Regulatory
Costs incurred by BeiGene that are directly attributed or fairly allocable to
the enrollment of the number of patients over [* * *] of all patients enrolled
worldwide (the “JGS Territory Extra Patients”) and the portion of Clinical
Trials conducted in the Territory with respect to such JGS Territory Extra
Patients that constitute part of the Joint Global Study (the “JGS Territory
Extra Costs”). If AssemblyBio is obligated to reimburse any JGS Territory Extra
Costs under this Section 5.4(c) during any Calendar Quarter, BeiGene shall issue
an invoice for such JGS Territory Extra Costs incurred during such Calendar

-30-

--------------------------------------------------------------------------------

Quarter that are subject to such reimbursement within [* * *] after the end of
such Calendar Quarter, and AssemblyBio shall pay the undisputed invoiced amounts
within [* * *] after the receipt of such invoice. On an annual basis or as may
be otherwise agreed between the Parties, the Parties will coordinate through the
JDC regarding any overpayments or underpayments made by AssemblyBio during the
immediately preceding Calendar Year and an adjustment payment shall be made by
or to AssemblyBio so that the total reimbursement amount paid by AssemblyBio for
such Calendar Year equals the actual JGS Territory Extra Costs incurred by
BeiGene during such Calendar Year.

(d)Territory Only Case Budget. For each of the (i) Licensed ABI-H0731 Product,
(ii) Licensed ABI-H2158 Product, and (iii) Licensed ABI-H3733 Product, the
Parties will discuss through the JDC and agree upon a baseline budget for the
Territory Only Case for such Licensed ABI-H0731 Product, Licensed ABI-H2158
Product or Licensed ABI-H3733 Product (as applicable), setting forth the total
expenditure of Development and Regulatory Costs that would be incurred therefor
in the scenario of a Territory Only Case (the “Territory Only Case Budget”). In
the event that the Parties disagree regarding the Territory Only Case Budget,
[* * *]. The budget for BeiGene’s Development activities in the Territory under
the applicable Development Plan shall be consistent with the Territory Only Case
Budget. Notwithstanding any provisions to the contrary hereunder, in the event
BeiGene’s total expenditure on Development and Regulatory Costs in the Territory
for a Joint Global Study for the initial Regulatory Approval in relation to a
Licensed ABI-H0731 Product, Licensed ABI-H2158 Product or Licensed ABI-H3733
Product (as applicable) exceeds the applicable Territory Only Case Budget,
[* * *].

(e)Cost Sharing Examples. For the avoidance of doubt, the cost-sharing concepts
set forth under this Section 5.4 are intended to follow the principles and
examples set forth in Exhibit 5.4(e).

(f)Development and Regulatory Costs. For clarity, all Development and Regulatory
Costs covered under this Section 5.4 will be subject to the restrictions set
forth in the definition of “Development and Regulatory Costs”, including clauses
(x), (y) and (z) and the treatment of budget overage thereunder.

5.5New Development Activities in the Territory.

(a)New Development Proposal. Either Party may propose with respect to the
Licensed Products in the Territory new Development activities (including the
Development of a Licensed Product for a new Indication or as part of a
Combination Product, excluding the Development of Licensed Products before the
Initiation of Phase 3 Clinical Trial thereof) not currently set forth in an
existing Territory Development Plan with its study design, protocol, specific
Development activities allocated to each Party, and the budget for such
allocated activities (each proposal, a “New Development Proposal”). The JDC will
review, discuss and determine whether to approve each New Development Proposal
within [* * *] after the receipt thereof. If the JDC approves by consensus such
New Development Proposal, (i) the Parties will, through the JDC, update the
Territory Development Plan to include the Development activities proposed in the
New Development Proposal, and (ii) the Development and Regulatory Costs incurred
with respect to the Development activities proposed in the approved New
Development Proposal will be subject to Section 5.4.

-31-

--------------------------------------------------------------------------------

(b)Unilateral Development Activities. If the JDC does not approve a New
Development Proposal, then the proposing Party may not exercise its final
decision-making authority under Section 3.2(f) to override such JDC decision,
but may proceed with such proposed Development activities in the Territory at
its own cost and expense (such activities, the “Unilateral Development
Activities”); except that if the non-proposing Party objects to such New
Development Proposal based on the AssemblyBio Veto Right or BeiGene Veto Right
(as applicable), the proposing Party shall not proceed with such proposed
Development activities in such New Development Proposal. The other Party shall
not have access to the Know-How and Clinical Data generated through the
Unilateral Development Activities, unless and until such other Party reimburses
the proposing Party [* * *] of the Costs incurred by the proposing Party in
relation to the conduct of the Unilateral Development Activities.
Notwithstanding the foregoing, the other Party may access safety data resulting
from such Unilateral Development Activities pursuant to Section 5.9 without the
foregoing payment obligation.

(c)AssemblyBio Ancillary Trials. The Parties acknowledge that AssemblyBio will
conduct certain AssemblyBio Ancillary Trials which may be outside of the scope
of any Development Plan. AssemblyBio will be solely responsible for conducting
such AssemblyBio Ancillary Trials outside of the Development Plans at its own
costs.  The proposed budget for the AssemblyBio Ancillary Trials for the
Licensed ABI-H0731 Products in the pipeline as of the Effective Date is set
forth on Exhibit 5.5(c) (the “AssemblyBio Ancillary Trials Budget”). In the
event BeiGene elects to have access and a right of reference to the Know-How and
the Clinical Data resulting from any such AssemblyBio Ancillary Trial(s) (other
than safety data which will be exchanged in accordance with Section 5.9),
BeiGene shall reimburse AssemblyBio [* * *] of the Costs incurred by AssemblyBio
in relation to such AssemblyBio Ancillary Trial(s) (only to the extent such
Costs are incurred after the Effective Date), provided that (i) with respect to
AssemblyBio Ancillary Trials for the Licensed ABI-H0731 Products, such
reimbursement obligations shall not apply to any such Costs [* * *]; and (ii)
with respect to AssemblyBio Ancillary Trials for the Licensed ABI-H2158 Products
or for Licensed ABI-H3733 Products, BeiGene’s reimbursement obligations under
this Section 5.5(c) shall only apply to the extent [* * *] and the Costs
incurred by AssemblyBio in relation to such AssemblyBio Ancillary Trials for
Licensed ABI-H2158 Products or for Licensed ABI-H3733 Products (as applicable)
do not [* * *] (i) (adjusted to [* * *]). All such Costs must be recorded in
accordance with the Accounting Standards and either directly attributed to or
fairly allocable to the conduct of the AssemblyBio Ancillary Trials.

5.6Development Records. BeiGene shall maintain reasonably complete, current and
accurate records of (a) all Development activities conducted by or on behalf of
BeiGene, its Affiliates or its sublicensees pursuant to this Agreement, the
Global Development Plan or the Territory Development Plan, (b) all Development
and Regulatory Costs incurred in connection with such Development activities,
and (c) all data and other information resulting from such activities, in each
case in accordance with all Applicable Laws. BeiGene shall maintain such records
during the Term and for a period of time after the Term consistent with
Applicable Laws and reasonable industry practices on record retention and
destruction (which shall not be less than three (3) years).  Such records will
be in English (or include complete English translations) and shall fully and
properly reflect all work done and results achieved by or on behalf of BeiGene
in the performance of the Development activities in the Territory hereunder, in
good scientific manner appropriate for regulatory and patent purposes.  BeiGene
shall document all non-clinical

-32-

--------------------------------------------------------------------------------

studies and Clinical Trials of a Licensed Product in formal written study
reports in accordance with Applicable Laws and national and international
guidelines (e.g., GCP, GLP and cGMP). Upon AssemblyBio’s request, BeiGene shall,
and shall cause its Affiliates and sublicensees to, provide AssemblyBio with
copies of such records.

5.7Clinical Trial Audit Rights.

(a)Upon reasonable notification by AssemblyBio and at AssemblyBio’s cost and
expense, AssemblyBio or its representatives shall be entitled to conduct an
audit of any Clinical Trial sites or vendors engaged, or other facilities used,
by BeiGene or its Affiliates or sublicensees to conduct BeiGene’s obligations
under the Global Development Plan and Territory Development Plan, to ensure that
such Clinical Trials are conducted in compliance with the Global Development
Plan, Territory Development Plan and all Applicable Laws, including GCP. No
later than [* * *] following the completion of any such audit, AssemblyBio will
provide BeiGene with a written summary of AssemblyBio’s findings in English,
including any deficiencies or other areas of remediation that AssemblyBio
reasonably identifies during such audit and the Parties shall promptly meet to
discuss any such deficiencies or other areas of remediation identified by
AssemblyBio. BeiGene will use Commercially Reasonable Efforts to remediate such
deficiencies promptly following BeiGene’s receipt of such report, at BeiGene’s
cost and expense.    

(b)BeiGene will provide AssemblyBio with copies of all quality oversight or
audit reports, including certified translations into English thereof, prepared
in connection with any audit that BeiGene, its Affiliates or sublicensees
conduct of a Clinical Trial site or vendor that BeiGene, its Affiliates or
sublicensees have engaged or are evaluating to potentially engage to fulfill
BeiGene’s obligations under the Global Development Plan or the Territory
Development Plan no later than [* * *] after receiving or preparing, as
applicable, any such report.

5.8Development Reports. BeiGene shall provide AssemblyBio with [* * *] written
reports (which may be in the form of PowerPoint or Excel presentations), at
least [* * *], summarizing its, its Affiliates’ and its sublicensees’
Development of Licensed Products, including a summary of the results of such
Development and the Development and Regulatory Costs incurred in connection with
such Development activities, which reports shall be in English (the “BeiGene
Development Report”). Without limiting the foregoing, such reports shall contain
(a) sufficient detail to enable AssemblyBio to assess BeiGene’s compliance with
its Development obligations hereunder, (b) the total amount of and a detailed
summary of Development and Regulatory Costs incurred for the Development
activities conducted by BeiGene for each Licensed Product in each region during
the past [* * *], including, as may be applicable, the Development and
Regulatory Costs incurred for any Joint Global Study, (c) the cumulative amount
of Development and Regulatory Costs that have been incurred by BeiGene to date
from the Effective Date subject to Section 5.4, and (d) a non-binding good-faith
estimate of the Development and Regulatory Costs to be incurred by BeiGene
during the then-ongoing [* * *]. Without limiting the foregoing, within [* * *]
following the end of each [* * *], BeiGene shall provide AssemblyBio with a
good-faith estimate of information under foregoing clauses (b) through (d) to be
set forth in the next BeiGene Development Report to follow. Subject to
AssemblyBio’s right to use and disclose data and results in accordance with
Section 5.9 and the licenses and rights granted to AssemblyBio in Section 2.4,
such reports shall be Confidential Information of BeiGene pursuant to Article
10. BeiGene shall promptly respond to AssemblyBio’s reasonable requests from
time to time for additional information regarding material Development
activities. The Parties shall review

-33-

--------------------------------------------------------------------------------

each BeiGene Development Report and discuss the status, progress and results of
Development activities and the related costs at JSC meetings, and AssemblyBio
shall keep BeiGene reasonably informed through the JDC as to any material
developments with respect to the Development of Licensed Products outside the
Territory.

5.9Data Exchange and Use. In addition to its adverse event and safety data
reporting obligations pursuant to Section 6.4 and except to the extent excluded
pursuant to Sections 5.5(b) and 5.5(c), each Party shall promptly (but in any
event no later than [* * *] from the other Party’s request) provide the other
Party with copies of all data and results, including all Clinical Data and all
supporting documentation (e.g., protocols, CRFs, analysis plans) Controlled by
such Party or its Affiliates that are generated by or on behalf of such Party or
its Affiliates or sublicensees, if applicable, in the Development of Licensed
Products; provided that AssemblyBio shall only be required to provide BeiGene
such data, results and documentation to the extent it comprises AssemblyBio
Know-How and is necessary or reasonably useful for BeiGene’s Development or
Commercialization of the Licensed Products in the Field in the Territory,
including any such data, results and documentation that are reasonably requested
by BeiGene or that are necessary to support filings for Regulatory Approval for
a Licensed Product in the Territory.  AssemblyBio agrees to use Commercially
Reasonable Efforts to [* * *]. BeiGene shall have the right to use and reference
such data and results provided by AssemblyBio, without additional consideration,
for the purpose of obtaining and maintaining Regulatory Approvals and any
Pricing and Reimbursement Approvals, as applicable, of Licensed Products in the
Field in the Territory. AssemblyBio and its designees shall have the right to
use and reference such data and results provided by BeiGene, without additional
consideration, for the purpose of (a) Developing, Manufacturing and
Commercializing Licensed Products in accordance with the licenses granted under
Section 2.4, (b) filing Patent Rights covering AssemblyBio’s Inventions and
Product-Specific IP, (c) obtaining and maintaining Regulatory Approval and any
Pricing and Reimbursement Approvals, as applicable, of Licensed Products outside
the Field in the Territory or outside of the Territory, and (d) seeking,
obtaining and maintaining a Clinical Trials Application for any Licensed Product
in the Field in the Territory in accordance with AssemblyBio’s retained rights
under Section 2.3. For clarity, any such data or results that are Inventions
will be owned in accordance with Section 14.1 and subject to the licenses,
rights and obligations set forth herein.

5.10Subcontractors.

(a)BeiGene shall have the right to engage subcontractors for purposes of
conducting activities assigned to it under this Agreement or for which it is
responsible under this Agreement. BeiGene shall cause any subcontractor engaged
by it to be bound by written obligations of confidentiality and non-use
consistent with this Agreement prior to performing any activities. BeiGene shall
cause its subcontractors to assign to BeiGene (or, in the case of academic
institutions or Clinical Trial sites, use reasonable efforts to cause such
subcontractor to so assign, and in any event cause such entity to grant an
option for a license to use) all intellectual property made by such
subcontractor in the course of performing such subcontracted work. BeiGene shall
remain directly responsible for any obligations under this Agreement that have
been delegated or subcontracted to any subcontractor and shall be directly
responsible for the performance of its subcontractors.

-34-

--------------------------------------------------------------------------------

(b)Without limiting the foregoing, BeiGene shall obtain AssemblyBio’s written
approval, such approval not to be unreasonably withheld, conditioned or delayed,
prior to engaging any contract research organization to perform services (i)
[* * *], or (ii) [* * *].

(c)AssemblyBio may conduct any activities assigned to it under the Global
Development Plan or this Agreement through one or more Affiliates or Third Party
designees.

Article 6

REGULATORY

6.1Holder of Regulatory Approvals and Regulatory Submissions. To the extent
permissible under Applicable Law, BeiGene shall be the holder of Regulatory
Approvals and Regulatory Submissions for Licensed Products in the Field in the
Territory. To the extent the foregoing is not permissible under Applicable Law,
then AssemblyBio shall be the holder of Regulatory Approvals and Regulatory
Submissions for Licensed Products in the Field in the Territory, and BeiGene
shall act as the authorized regulatory agent of record for AssemblyBio in the
Territory and take actions on behalf of and for the benefit of AssemblyBio in
accordance with the Applicable Law. AssemblyBio shall reasonably cooperate with
BeiGene, at BeiGene’s request and expense, to enable BeiGene to obtain any or
all such Regulatory Approvals and Regulatory Submissions.  

6.2Review of Regulatory Submissions.

(a)BeiGene shall provide to AssemblyBio all Regulatory Submissions (including
certified English translations thereof) prepared by or on behalf of BeiGene at
least [* * *] prior to submission and shall consider in good faith any
reasonable comments received from AssemblyBio with respect thereto. AssemblyBio
shall provide BeiGene with copies of all Clinical Trial Applications for the
Licensed ABI-H0731 Products in the Territory (including certified English
translations thereof) prepared by or on behalf of AssemblyBio.

(b)In addition, each Party shall notify the other Party of any comments or other
material correspondence regarding any Regulatory Submissions that are received
from any Regulatory Authority in the Territory or, with respect to Clinical
Trials conducted pursuant to the Global Development Plan, outside the Territory,
and shall provide the other Party with copies thereof as soon as reasonably
practicable, but in all events within [* * *] of receipt (or such longer time
period as may be necessary to obtain translations thereof).  Each Party will
provide quarterly updates, at each JDC meeting, regarding its activities and
progress with respect to all Clinical Trials conducted pursuant to the Global
Development Plan or the Territory Development Plan.

(c)Each Party shall keep the other Party reasonably informed of regulatory
developments related to Licensed Products in the Field in the Territory and
outside the Territory of which it becomes aware and shall promptly notify the
other Party in writing of any material decision by any Regulatory Authority in
the Field, in the Territory and outside the Territory, of which it becomes aware
regarding any Licensed Product.  

(d)Each Party shall provide the other Party with notice no later than [* * *]
after receiving notice of any material meeting or substantive communication with
any Regulatory Authority in the Territory related to any Licensed Product in the
Field.  Each Party shall provide

-35-

--------------------------------------------------------------------------------

the other Party with a written summary of each such meeting or substantive
communication in English promptly following such meeting or
discussion.  AssemblyBio or its designee will have the right, but not the
obligation, to attend and observe any such meeting or discussion with Regulatory
Authorities in the Territory unless prohibited or restricted by Applicable Law
or the Regulatory Authorities; provided that BeiGene shall not be obligated to
schedule such meetings to specifically enable AssemblyBio’s or its designee’s
attendance.  Without limiting the generality of the foregoing, with respect to
ABI-H0731 and Licensed ABI-H0731 Products, (i) until the study protocols of the
Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the
applicable Regulatory Authorities in the Territory, AssemblyBio shall be the
leading Party for the discussion and interactions with Regulatory Authorities in
the Territory with respect to the Licensed ABI-H0731 Products, taking into
account in good faith comments and input from BeiGene related thereto; (ii)
after the study protocols of the Phase 3 Clinical Trials for the Licensed
ABI-H0731 Products are approved by the applicable Regulatory Authorities in the
Territory, BeiGene shall be the leading Party for the discussion and
interactions with Regulatory Authorities in the Territory with respect to the
Licensed ABI-H0731 Products, taking into account in good faith comments and
input from AssemblyBio related thereto; and (iii) BeiGene shall have the right
to participate in any meeting between AssemblyBio and Regulatory Authorities in
the Territory regarding the Clinical Trials for ABI-H0731 and Licensed ABI-H0731
Products unless prohibited or restricted by Applicable Law or the Regulatory
Authorities, provided that AssemblyBio shall not be obligated to schedule such
meetings to specifically enable BeiGene’s or its designee’s attendance.

6.3Right of Reference. Each Party hereby grants to the other Party the right of
reference to all Regulatory Submissions pertaining to Licensed Products in the
Field submitted by or on behalf of such Party or its Affiliates, solely to the
extent reasonably necessary for the purposes set forth in this Section 6.3 and
requested by such other Party. BeiGene may use such right of reference to
AssemblyBio’s Regulatory Submissions solely for the purpose of seeking,
obtaining and maintaining Regulatory Approvals and any Pricing and Reimbursement
Approvals, as applicable, of Licensed Products in the Field in the Territory.
AssemblyBio may use such right of reference to BeiGene’s Regulatory Submissions
and Regulatory Approvals solely for the purpose of (a) seeking, obtaining and
maintaining Regulatory Approvals and any Pricing and Reimbursement Approval of
Licensed Products outside the Territory or (b) seeking, obtaining and
maintaining a Clinical Trials Application for any Licensed Product in the Field
in the Territory only to the extent included within AssemblyBio’s retained
rights under Section 2.3.  The Party requesting such right of reference shall
bear the reasonable costs and expenses of the other Party associated with
providing the right of reference pursuant to this Section 6.3. Each Party will
take such actions as may be reasonably requested by the other Party to give
effect to the intent of this Section 6.3 and to give the other Party the benefit
of the rights of reference to the granting Party’s Regulatory Submissions in the
other Party’s territory as provided herein.  

6.4Adverse Events Reporting. Within [* * *] after the Effective Date, BeiGene
and AssemblyBio shall develop and agree in a written agreement to worldwide
safety and pharmacovigilance procedures for the Parties with respect to Licensed
Products, such as safety data sharing and exchange, adverse events reporting and
prescription events monitoring (the “Pharmacovigilance Agreement”).

-36-

--------------------------------------------------------------------------------

6.5Safety and Regulatory Audits and Inspections.

(a)Safety and Regulatory Audits. Upon reasonable advance (not less than [* * *]
written notification), AssemblyBio or its representatives shall be entitled to
conduct an audit of the safety and regulatory systems, procedures or practices
of BeiGene and its Affiliates relating to the Licensed Products no more often
than [* * *] period. Upon AssemblyBio’s reasonable request, BeiGene will conduct
such audits of its sublicensees and subcontractors hereunder (subject to the
terms and conditions of BeiGene’s agreements with such sublicensees and
subcontractors) and provide AssemblyBio with the results of such audits.

(b)Safety and Regulatory Inspections. BeiGene shall promptly notify AssemblyBio
of any inspection of BeiGene, its Affiliates, CMOs, sublicenses or
subcontractors (including Clinical Trial sites) by any Regulatory Authority
relating to Licensed Products and shall provide AssemblyBio with all information
in BeiGene’s Control pertinent thereto. Without limiting the foregoing, BeiGene
shall permit Regulatory Authorities outside the Territory to conduct inspections
of BeiGene, its Affiliates, CMOs, sublicensees or subcontractors (including
Clinical Trial sites) relating to Licensed Products, and shall ensure that such
Affiliates, CMOs, sublicensees and subcontractors permit such inspections.
AssemblyBio shall have the right, but not the obligation, to be present at and
participate in any such inspection described in this Section 6.5(b) [* * *].
BeiGene will provide AssemblyBio with a written summary in English of any
findings of a Regulatory Authority relating to Licensed Products following a
regulatory audit (and any written correspondences in relation thereto) within
[* * *] following any such audit, and will provide AssemblyBio with an
unredacted copy of any report issued by such Regulatory Authority, including if
applicable, a certified English translation thereof within [* * *] following
such audit.

6.6No Harmful Actions. If either Party reasonably believes that the other Party
is taking or intends to take any action with respect to a Licensed Product in
such other Party’s territory that would reasonably be expected to have a
material adverse impact upon the regulatory status of any Licensed Product in
the Field in its respective territory, then such Party shall have the right to
bring the matter to the attention of the JSC, and the Parties shall discuss in
good faith a resolution to such concern. Without limiting the foregoing, unless
the Parties otherwise agree (or unless otherwise set forth herein or in the
Global Development Plan): (a) neither Party shall communicate with any
Regulatory Authority having jurisdiction outside of its respective territory
with respect to any Licensed Product, unless required by such Regulatory
Authority, in which case such Party shall notify the other Party of such order
within [* * *] of such communication; and (b) neither Party shall submit any
Regulatory Submissions or seek Regulatory Approvals for any Licensed Product in
the other Party’s respective territory, except AssemblyBio’s right to seek,
obtain and maintain Clinical Trial Applications for the Licensed Products in the
Field in the Territory in accordance with AssemblyBio’s retained rights under
Section 2.3, which shall not be limited.

6.7Notice of Regulatory Action. If any Regulatory Authority takes or gives
notice of its intent to take any regulatory action with respect to any activity
of BeiGene relating to the Licensed Product, then BeiGene shall notify
AssemblyBio of such notice within [* * *] of its receipt thereof. AssemblyBio
shall have the right to review and comment on any responses to Regulatory
Authorities that pertain to a Licensed Product promptly and in any event within
[* * *] of receipt of such proposed response.  BeiGene will [* * *] to a
Licensed Product in the Territory and will [* * *].  AssemblyBio will [* * *] to
a Licensed Product outside of the Territory and will

-37-

--------------------------------------------------------------------------------

[* * *]. The costs and expenses of any regulatory action in the Territory will
be included among the Development and Regulatory Costs and shared in accordance
with Section 5.4. In addition, each Party shall promptly notify the other Party
of any information it receives regarding any threatened or pending action,
inspection or communication by or from a Third Party that, in the case of notice
to AssemblyBio, would reasonably be expected to materially affect the
Development or Commercialization of the Licensed Products, and in the case of
notice to BeiGene, would reasonably be expected to materially affect the
Development or Commercialization of the Licensed Products in the Field in the
Territory.

Article 7.  

MANUFACTURING

7.1Manufacture of Licensed Product for the Territory.  Subject to the terms and
conditions of this Article 7, BeiGene shall have the right to (a) purchase
Development supply from AssemblyBio or AssemblyBio’s CMO pursuant to the
Clinical Supply Agreement, and (b) purchase commercial supply of Licensed
Product from AssemblyBio or AssemblyBio’s CMO pursuant to the Commercial Supply
Agreement.

7.2Supply by AssemblyBio.

(a)Development Supply. AssemblyBio shall, either by itself or through a CMO,
Manufacture and supply to BeiGene all Licensed Products required by BeiGene for
Development use in the Territory under the Territory Development Plan and for
BeiGene’s Development-related responsibilities under the Global Development
Plan, subject to the terms and conditions of the Clinical Supply Agreement. The
Parties shall use Commercially Reasonable Efforts to enter into an agreement
governing the supply by AssemblyBio of such Licensed Products for such
Development use by BeiGene (“Clinical Supply Agreement”) within [* * *] after
the Effective Date, pursuant to which BeiGene shall purchase its clinical
requirements for Licensed Product in the Territory from
AssemblyBio.  AssemblyBio shall supply the Licensed Products pursuant to this
Section 7.2(a) in [* * *] at a transfer price [* * *]. AssemblyBio shall invoice
BeiGene for Licensed Products [* * *] in accordance with this Section 7.2 and
BeiGene shall, subject to the terms of the Clinical Supply Agreement, pay the
undisputed invoiced amounts within [* * *] after the date of such
invoice.  Notwithstanding the foregoing, in the event AssemblyBio will incur,
[* * *], any advance fee or charge, including a slot reservation fee, advance
raw material charges, or other similar fees or charges for Manufacture of
Licensed Product solely for BeiGene, AssemblyBio may invoice BeiGene for such
fee or charge, as applicable, [* * *], and BeiGene shall, pay such invoiced
amounts within [* * *] after the date of such invoice.  Amounts paid by BeiGene
for clinical supply of Licensed Products under this Agreement will be included
among Development and Regulatory Costs and shared by the Parties in accordance
with Section 5.4.

(b)Commercial Supply. The Parties shall use Commercially Reasonable Efforts to
agree, not later than [* * *] prior to the anticipated launch date of a Licensed
Product in the Territory, on the principal terms of a commercial supply
agreement (the “Commercial Supply Agreement”) pursuant to which BeiGene shall
purchase commercial supply of a Licensed Product for the Territory from
AssemblyBio or AssemblyBio’s CMO.  The transfer price under the Commercial
Supply Agreement shall be [* * *].  The terms of the Commercial Supply Agreement
shall be consistent with the terms and conditions of this Agreement, the
applicable terms and

-38-

--------------------------------------------------------------------------------

conditions of Clinical Supply Agreement, and the terms and conditions of any
agreement between AssemblyBio and its CMOs, to the extent applicable to
commercial supply of Licensed Product in the Field in the Territory. The Parties
shall negotiate in good faith and endeavor to enter into such Commercial Supply
Agreement at least [* * *] prior to the estimated date of enrollment of the last
patient in the first Phase 3 Clinical Trial of such Licensed Product in the
Territory. Unless and until otherwise agreed by the Parties, and except as
otherwise set forth in the Commercial Supply Agreement, BeiGene shall purchase
its commercial requirements for Licensed Product in the Territory from
AssemblyBio pursuant to the Commercial Supply Agreement. AssemblyBio shall
invoice BeiGene for the Licensed Products [* * *] and BeiGene shall, subject to
the terms of the Commercial Supply Agreement, pay the undisputed invoiced
amounts within [* * *] after the date of such invoice.

(c)Delivery. Delivery of Licensed Products supplied by AssemblyBio for
Development and Commercialization will be made EXW (Incoterms 2020) designated
facilities of AssemblyBio or its CMOs. BeiGene shall contract for shipment and
insurance of such Licensed Product from AssemblyBio’s or its CMO’s
facility.  BeiGene shall be responsible for obtaining all licenses or other
authorizations for the importation of such Licensed Product, [* * *]. BeiGene
shall also be responsible for the clinical packaging, labeling, QC/QA/QP
release, storage, customs clearance and distribution of such Licensed Product,
[* * *].

(d)Fully Burdened Manufacturing Cost Adjustment.  

(i)BeiGene and AssemblyBio will act in good faith and use Commercially
Reasonable Efforts to work with each other to reduce the Fully Burdened
Manufacturing Cost under both the Clinical Supply Agreement and Commercial
Supply Agreement. Fully Burdened Manufacturing Cost reduction measures, along
with all discussions and decisions regarding Manufacturing will be discussed and
decided through the JMC.  The Fully Burdened Manufacturing Cost reduction
measures to be discussed at the JMC may include: (A) activities and measures
required to streamline, enhance and optimize the manufacturing process,
including for materials and equipment related thereto, (B) the possibility of
BeiGene taking on some, or all, of Manufacturing for the Territory and/or
potentially becoming a second supplier for AssemblyBio globally, and (C) any
other technical or business solutions aimed at reducing Fully Burdened
Manufacturing Cost (collectively, “Joint COGM Improvements”).

(ii)If the [* * *] Fully Burdened Manufacturing Cost with respect to any
Calendar Quarter is greater than [* * *], then upon written notice by BeiGene to
AssemblyBio, the Parties agree to promptly discuss in good faith appropriate
adjustment or compensation to be provided by AssemblyBio to BeiGene (including
[* * *]), taking into account: (A) [* * *], (B) [* * *], (C) [* * *], and (D)
[* * *].  If the Parties cannot agree, such decision will be referred to the
Executive Officers for decision in accordance with Section 16.6(a) and, if the
Executive Officers cannot agree, [* * *].

(iii)For clarity, if the Fully Burdened Manufacturing Cost with respect to any
Calendar Quarter is equal to or below [* * *], then Section 7.2(d)(ii) shall not
apply with respect to such Calendar Quarter, and instead Section 9.6(c)(v) shall
apply, if and as applicable, with respect to such Calendar Quarter.
Notwithstanding any provision to the contrary hereunder, in no event shall both
Sections 7.2(d)(ii) and 9.6(c)(v) apply at the same time.

-39-

--------------------------------------------------------------------------------

(e)Single Agreement.  The Parties may agree to execute a single supply agreement
pursuant to which AssemblyBio (or its CMO) would supply BeiGene Licensed
Products for the Territory, rather than a separate Clinical Supply Agreement and
Commercial Supply Agreement.  

7.3Manufacturing in Territory.  In the event that (a) the Applicable Laws or the
Regulatory Authorities in the Territory require, or (b) BeiGene becomes aware of
any potential changes under the Applicable Laws or the requirements of
Regulatory Authorities in the Territory that are reasonably likely to become
effective within the next [* * *], which would require, in either case (a) or
(b), the Licensed Products to be Manufactured in the Territory, then BeiGene
shall bring this matter to the attention of JMC to be discussed in good faith
between the Parties. If the Parties agree, or if in the opinion of BeiGene’s
external legal counsel, such requirement under the Applicable Laws or by
Regulatory Authorities exist or are likely to become effective in the Territory
within the next [* * *], then the Parties shall discuss and approve appropriate
measures to meet such actual or potential requirements, which may include: (i)
AssemblyBio to Manufacture, or have Manufactured through its CMO, the applicable
Licensed Products in the Territory for supply to BeiGene, or (ii) BeiGene to
take on some or all of the Manufacturing activities of the applicable Licensed
Products in the Territory.

Article 8

COMMERCIALIZATION

8.1Commercialization Responsibility.

(a)BeiGene shall be solely responsible for Commercializing the Licensed Products
in the Field in the Territory in accordance with this Article 8 and shall book
all sales of such Licensed Products in the Territory. BeiGene shall use
Commercially Reasonable Efforts to Commercialize each Licensed Product in each
region in which such Licensed Product receives Regulatory Approval and Pricing
and Reimbursement Approval in the Field.  BeiGene shall conduct all
Commercialization of Licensed Products in the Field in the Territory in
accordance with the Global Commercialization Principles (subject to [* * *]) and
the Territory Commercialization Plan for such Licensed Product and all
Applicable Laws, at its sole cost and expense.

(b)As between the Parties, AssemblyBio shall have the sole right to
Commercialize each Licensed Product outside of the Territory and outside the
Field in the Territory, and to book all such sales of Licensed Products outside
of the Territory and outside the Field in the Territory.

8.2Global Commercialization Principles and Territory Commercialization Plan.

(a)Global Commercialization Principles. AssemblyBio shall prepare and deliver an
initial draft of the Global Commercialization Principles to the JCC for its
review, discussion and approval not later than [* * *] prior to the anticipated
date of the first filing of the first Regulatory Approval for the applicable
Licensed Product in any country or jurisdiction. Thereafter, either Party may
propose updates or amendments to the Global Commercialization Principles, which
updates or amendments shall be reviewed and approved by the JCC.

-40-

--------------------------------------------------------------------------------

(b)Territory Commercialization Plan. The Territory Commercialization Plan with
respect to a Licensed Product shall contain in reasonable detail the major
Commercialization activities planned for such Licensed Product in the Territory,
including any activities in relation to medical affairs. The Territory
Commercialization Plan shall be consistent with the Global Commercialization
Principles. BeiGene shall deliver an initial draft of the Territory
Commercialization Plan to the JCC for its review, discussion and approval no
later than [* * *] prior to the anticipated date of the first filing of the
first Regulatory Approval for a Licensed Product in the Territory. AssemblyBio
shall have the right to comment through the JCC on such Territory
Commercialization Plan, and BeiGene shall [* * *] prior to finalizing such
Territory Commercialization Plan. BeiGene shall promptly provide AssemblyBio
with a copy of such final Territory Commercialization Plan, and thereafter, from
time to time, but at least [* * *], BeiGene shall propose updates or amendments
to the Territory Commercialization Plan to reflect any changes in such plans,
including those made in response to changes in the marketplace, relative
commercial success of such Licensed Product, and other relevant factors that may
influence such plan and activities. BeiGene shall submit the proposed updated or
amended Territory Commercialization Plan to the JCC for review, discussion and
approval before implementing such update or amendment.

8.3Commercialization Reports. For each Calendar Year following receipt of the
first Regulatory Approval and, if applicable, Pricing and Reimbursement Approval
for any Licensed Product in any region in the Territory, BeiGene shall provide
to AssemblyBio annually within [* * *] after the end of each Calendar Year a
written report that summarizes the Commercialization activities on a Licensed
Product-by-Licensed Product and region-by-region basis, as applicable, performed
by or on behalf of BeiGene, its Affiliates and sublicensees in the Territory
since the prior report provided by BeiGene. Such reports shall be Confidential
Information of BeiGene, subject to Article 10. BeiGene shall provide updates to
any such report at each meeting of the JSC and the JCC.

8.4Coordination of Commercialization Activities.

(a)The Parties recognize that they may benefit from the coordination of certain
activities in support of the Commercialization of Licensed Products in and
outside the Territory. As such, the Parties shall coordinate such activities
where appropriate, which may include scientific and medical communication and
product positioning.

(b)BeiGene shall keep AssemblyBio timely informed on the status of any
application for Pricing and Reimbursement Approvals for Licensed Products in the
Field in the Territory, including any discussion with the applicable Regulatory
Authority with respect thereto.  Each Party shall have the right to determine
the price of Licensed Products sold in its territory and neither Party shall
have the right to direct, control or approve the pricing of Licensed Products
sold by the other Party in such other Party’s territory, provided that all
pricing matters for Licensed Products in the Territory shall be reviewed and
discussed by the JCC, subject to BeiGene’s final decision-making authority on
such pricing matters.

(c)BeiGene will use Commercially Reasonable Efforts to cooperate with
AssemblyBio in AssemblyBio’s development and adoption of a global branding
strategy for the Licensed Products, which may include certain distinctive
colors, logos, images, symbols, and trademarks to be used in connection with the
Commercialization of Licensed Products on a global

-41-

--------------------------------------------------------------------------------

basis (such branding elements, collectively, the “Global Brand Elements”).
AssemblyBio shall own all rights in such Global Brand Elements and shall grant
BeiGene the exclusive right to use such Global Brand Elements in connection with
the Commercialization of Licensed Products in the Field in the Territory.
BeiGene shall Commercialize Licensed Products in the Territory in a manner
consistent with the Global Brand Elements to the extent included in the
Territory Commercialization Plan. The branding strategy in the Territory shall
be included in the Territory Commercialization Plan and reviewed by the JCC,
subject to BeiGene’s final decision-making authority on such branding matters.

8.5Diversion. Each Party covenants and agrees that it shall not, and shall
ensure that its Affiliates and sublicensees shall not, either directly or
indirectly, promote, market, distribute, import, sell or have sold any Licensed
Products, including via the Internet or mail order, to any Third Party or to any
address or Internet Protocol address or the like in the other Party’s territory;
provided that each Party shall have the right to attend conferences and meetings
of congresses in the other Party’s territory and to promote and market Licensed
Products to Third Party attendees at such conferences and meetings, subject to
this Section 8.5. Neither Party shall engage, nor permit its Affiliates or
sublicensees to engage, in any advertising or promotional activities relating to
any Licensed Products for use directed primarily to customers or other buyers or
users of Licensed Products located in any country or jurisdiction in the other
Party’s territory, or solicit orders from any prospective purchaser located in
any country or jurisdiction in the other Party’s territory. If a Party or its
Affiliate or sublicensee receives any order for Licensed Products for use from a
prospective purchaser located in a country or jurisdiction in the other Party’s
territory, such Party shall immediately refer that order to such other Party and
shall not accept any such orders. Neither Party shall, nor permit its
Affiliates, sublicensees or distributors to, deliver or tender (or cause to be
delivered or tendered) any Licensed Products for use in the other Party’s
territory.

-42-

--------------------------------------------------------------------------------

Article 9

PAYMENTS

9.1Upfront Fee. In partial consideration of AssemblyBio’s granting of the
licenses and rights to BeiGene hereunder and AssemblyBio’s undertaking of the
activities required under this Agreement, BeiGene shall pay to AssemblyBio a
one-time, non-refundable, non-creditable upfront payment of forty million USD
($40,000,000) (the “Upfront Payment”) within [* * *] following the Effective
Date.

9.2Development Milestones. Within [* * *] after the achievement of each
milestone event set forth in the table below for each of the [* * *] Licensed
Products (each, a “Development Milestone Event”), BeiGene shall make the
corresponding milestone payment to AssemblyBio (each, a “Development Milestone
Payment”) in accordance with Section 9.5(a).  Subject to Section 9.4, each
Development Milestone Payment shall be payable [* * *] Licensed Products, upon
the [* * *] of the corresponding Development Milestone Event for such Licensed
Product.

 

Development Milestone Event

Milestone Payment

[* * *]

[* * *]

[* * *]

[* * *]

1.    [* * *]*

[* * *]

[* * *]

[* * *]

2.    [* * *]*

[* * *]

[* * *]

[* * *]

3.    [* * *]**, ***

[* * *]

[* * *]

[* * *]

4.    [* * *]

[* * *]

[* * *]

[* * *]

5.    [* * *]

[* * *]

[* * *]

[* * *]

 

* Only [* * *] will be due for the [* * *] of a Licensed Product [* * *].

** If any Licensed Product achieves [* * *] without [* * *] (as such [* * *] may
be applicable to such Licensed Product), then [* * *] will become payable
[* * *].

*** As an example, in the event [* * *], it will [* * *] and AssemblyBio will
receive [* * *].  If subsequently [* * *], then [* * *] will [* * *] ([* * *])
and [* * *] ([* * *]).

The Development Milestone Payments set forth above are payable [* * *]
Development Milestone Event for [* * *]. For the purpose of this Agreement,
“[* * *]” means [* * *].

-43-

--------------------------------------------------------------------------------

9.3Commercialization Milestones.  Upon the [* * *] achievement of each milestone
event set forth in the table below with respect to a particular Licensed Product
(each, a “Commercialization Milestone Event”) for [* * *] Licensed Products,
BeiGene shall make the corresponding milestone payment to AssemblyBio (each, a
“Commercialization Milestone Payment”) in accordance with Section 9.5(b):

 

Commercialization Milestone

Event*

Milestone Payment

[* * *]

[* * *]

[* * *]

[* * *]

1.    [* * *]

[* * *]

[* * *]

[* * *]

2.    [* * *]

[* * *]

[* * *]

[* * *]

3.    [* * *]

[* * *]

[* * *]

[* * *]

4.    [* * *]

[* * *]

[* * *]

[* * *]

 

* As an example, in the event [* * *], it will [* * *] and AssemblyBio will
receive [* * *]. If thereafter, [* * *], then it will [* * *], and AssemblyBio
will receive [* * *].

The Commercialization Milestone Payments set forth above are payable [* * *].

In the event that [* * *], BeiGene shall pay AssemblyBio [* * *].  For example,
if [* * *], BeiGene would pay AssemblyBio [* * *] in Commercialization Milestone
Payments pursuant to this Section 9.3. Each milestone payment set forth above
shall be payable [* * *] Licensed Product.

9.4Product [* * *].  For purposes of calculating the Development Milestone
Payments and Commercialization Milestone Payments, a Licensed Product is [* * *]
if it [* * *].  For clarity, if a Licensed Product is [* * *], that [* * *]
would be considered a [* * *].

9.5Payment Terms.

(a)Development Milestone Payments. BeiGene shall provide AssemblyBio with notice
of the achievement of each Development Milestone Event within [* * *] thereafter
and make the corresponding Development Milestone Payment within [* * *] after
such achievement.  

(b)Commercialization Milestone Payments and Royalty Payments.  During the Term,
following the First Commercial Sale of a Licensed Product, BeiGene shall furnish
to AssemblyBio a written report for each Calendar Quarter showing the Net Sales
by Licensed Product sold by BeiGene and its Affiliates and sublicensees during
the reporting Calendar Quarter and the Licensed Product royalties payable under
this Agreement in sufficient detail to allow AssemblyBio to verify the amount of
Licensed Product royalties paid by BeiGene with respect to such Calendar
Quarter.  Each such report shall include, on a region-by-region and Licensed
Product-by-Licensed Product basis, (i) the total gross amount invoiced for
Licensed Product sold, (ii) the Net Sales of each Licensed Product and the
applicable deductions made to

-44-

--------------------------------------------------------------------------------

determine such Net Sales of Licensed Products (by category, as such deductions
are set forth under Section 1.60), (iii) a calculation of the royalty payment
for each Licensed Product (in USD) payable (including any royalty reduction made
in accordance with Section 9.6(c)), and (iv) the royalty payment in total for
all Licensed Products and the manner and basis for any currency conversion in
accordance with Section 9.8, and shall specify if each Commercialization
Milestone Event is achieved during such Calendar Quarter.  Such reports shall be
due no later than [* * *] following the end of each Calendar Quarter; provided
that, within [* * *] following the end of each Calendar Quarter, BeiGene shall
provide AssemblyBio with a good-faith estimate of the payment amounts to be set
forth in such reports to follow. The corresponding Commercialization Milestone
Payment(s) and Licensed Product royalties shown to have accrued by each report
provided under this Section 9.5(b) shall be due and payable on the date such
report is due.

9.6Royalty Payments to AssemblyBio.

(a)Royalty Rates. In further consideration of AssemblyBio’s grant of the rights
and licenses to BeiGene hereunder, BeiGene shall, during each applicable Royalty
Term, pay to AssemblyBio a tiered royalty on Net Sales [* * *] in the Territory
for each Calendar Year, at the percentage rates set forth below (subject to
Section 9.6(c)):

 

Calendar Year, Net Sales [* * *] in

the Territory

Royalty Rate

1.≤ USD [* * *]

[* * *]%

2.> USD [* * *]  - ≤ USD [* * *]

[* * *]%

3.>USD [* * *] -  ≤ USD [* * *]

[* * *]%

4.> USD [* * *] - ≤ USD [* * *]

[* * *]%

5.> USD [* * *]

[* * *]%

 

By way of illustration, assume in a Calendar Year that (i) Net Sales of [* * *]
in the Territory in USD total [* * *] USD ($[* * *]) and (ii) no adjustments or
deductions to payments under Section 9.6(c) apply. The total royalties due and
payable by BeiGene to AssemblyBio for such Net Sales of [* * *] would be [* * *]
USD ($[* * *]), calculated as follows:

 

$[* * *]

x

[* * *]

 

%

=

 

$[* * *]

$[* * *]

x

[* * *]

 

%

=

 

$[* * *]

$[* * *]

x

[* * *]

 

%

=

 

$[* * *]

$[* * *]

x

[* * *]

 

%

=

 

$[* * *]

$[* * *]

x

[* * *]

 

%

=

 

$[* * *]

Total Royalty

 

 

=

 

$[* * *]

(b)Royalty Term. The royalty payments payable under this Section 9.6 shall be
payable on a Licensed Product-by-Licensed Product and region-by-region basis
from the First Commercial Sale of such Licensed Product in such region in the
Territory until the latest of: (i)

-45-

--------------------------------------------------------------------------------

the [* * *] anniversary of the date of the First Commercial Sale of such
Licensed Product in such region; (ii) the expiration of the last Valid Claim
(including any patent term adjustments or extensions) within the AssemblyBio
Patent Rights that Covers such Licensed Product in such region; and (iii)
[* * *] for such Licensed Product in such region (the “Royalty Term”).

(c)Royalty Reductions.

(i)No Valid Claim. Subject to Section 9.6(c)(iv), on a Licensed
Product-by-Licensed Product and region-by-region basis, if there is no Valid
Claim within the AssemblyBio Patent Rights that Covers such Licensed Product in
a given region in the Territory, then, commencing in the first Calendar Quarter
after the date on which this Section 9.6(c)(i) applies and continuing for each
Calendar Quarter thereafter for so long as there is no Valid Claim that Covers
such Licensed Product in such region, the applicable royalty rate that would
otherwise be owed on such Net Sales of such Licensed Product in such region
under Section 9.6(a) will be reduced by [* * *].

(ii)Generic Product. If a Licensed Product is generating Net Sales in the Field
in a region in the Territory during the applicable Royalty Term at a time when
one or more Generic Products with respect to such Licensed Product is being sold
in such region, then the royalty rate applicable to Net Sales of such Licensed
Product in such region in such Calendar Quarter shall be reduced by (A) [* * *]
in any Calendar Quarter that BeiGene can demonstrate that [* * *], or (B)
[* * *] in any Calendar Quarter that BeiGene can demonstrate that [* * *].
BeiGene will promptly notify AssemblyBio upon BeiGene becoming aware of the
entry of such Generic Product(s), which notice will specify the applicable
Generic Product and its Indication, the applicable region in the Territory, and
the [* * *] of the Generic Products in such region (in each case, to the extent
then known by BeiGene).

(iii)Third Party Payments. With respect to any Third Party License entered into
by BeiGene pursuant to Section 14.5 for a Licensed Product in a region (for
licenses in connection with the Licensed Compound(s) in such Licensed Products
but not with respect to Other Components of a Combination Product), and during
any Calendar Quarter in which BeiGene makes royalty payments to the applicable
Third Party, BeiGene may credit against the royalty payments payable to
AssemblyBio pursuant to Section 9.6(a) with respect to such Licensed Product in
such region in such Calendar Quarter up to [* * *] for which BeiGene is
responsible under such Third Party License.

(iv)Royalty Floor. In no event will the aggregate amount of royalty payments due
to AssemblyBio for a Licensed Product in a region in the Territory in any given
Calendar Quarter during the Royalty Term for such Licensed Product in such
region be reduced to less than [* * *] of the amount that otherwise would have
been due and payable to AssemblyBio in such Calendar Quarter for such Licensed
Product in such region but for the reductions set forth in Sections 9.6(c)(i),
(ii) and (iii) (the “Royalty Floor”); provided that, subject always to the
Royalty Floor, [* * *].

(v)COGM Adjustment.  If the Fully Burdened Manufacturing Cost of a Licensed
Product is higher than [* * *], then [* * *] of the percent Fully Burdened
Manufacturing Cost [* * *] will be [* * *]. By way of example, if [* * *] and
the Fully Burdened Manufacturing

-46-

--------------------------------------------------------------------------------

Cost is [* * *], then the [* * *] would be [* * *].  If subsequently Fully
Burdened Manufacturing Cost are reduced to [* * *], the [* * *].

(vi)Compulsory Licenses. If a compulsory license is granted to a Third Party
with respect to a Licensed Product in any region in the Territory, to the extent
BeiGene is compensated on a royalty basis with a royalty rate lower than the
royalty rates provided by Section 9.6(a) (as adjusted per Sections 9.6(c)(i),
(ii) (iii) and (v)), the royalty rate to be paid by BeiGene on Net Sales made
pursuant to such compulsory license in such region under Section 9.6(a) will be
reduced to the rate payable by the compulsory licensee. For purposes of the
foregoing, a “compulsory license” means, with respect to a Licensed Product in a
country or territory, a license or rights granted to a Third Party by a
governmental agency within such country or territory to sell or offer for sale
such Licensed Product in such country or territory under any Patent Rights or
Know-How owned or Controlled by either Party or its Affiliates, without direct
or indirect authorization from such Party or its Affiliates.

9.7Payments to Third Parties. Except as expressly set forth herein, each Party
shall be solely responsible for any payments due to Third Parties under any
agreement entered into by such Party with respect to the Licensed Product, as a
result of activities hereunder.

9.8Payment Currency; Exchange Rate. All payments to be made under this Agreement
shall be made in USD.  Payments to AssemblyBio shall be made by electronic wire
transfer of immediately available funds to the account of AssemblyBio, as
designated in writing to BeiGene.  If any currency conversion is required in
connection with the calculation of amounts payable hereunder, such conversion
shall be made in a manner consistent with BeiGene’s normal practices used to
prepare its audited financial statements for external reporting purposes;
provided that such practices use a widely accepted source of published exchange
rates.

9.9Late Payments. Any payments or portions thereof due hereunder that are not
paid on the date such payments are due under this Agreement shall bear interest
at a rate equal to the lesser of: (a) [* * *] percentage points above the prime
rate as published by The Wall Street Journal or any successor thereto on the
first day of each Calendar Quarter in which such payments are overdue or (b) the
maximum rate permitted by Applicable Laws; in each case calculated on the number
of days such payment is delinquent, compounded monthly.

9.10Records and Audit Rights.

(a)Records.  Each Party will keep (and will cause its Affiliates and
sublicensees to keep) complete, true and accurate books and records in
sufficient detail for the other Party to determine payments due to such other
Party under this Agreement, including Licensed Product royalty payments and for
each Party to calculate Development and Regulatory Costs hereunder.  Each Party
will keep such books and records for at least [* * *] following the end of the
Calendar Year to which they pertain (or a longer period that may be required by
Applicable Laws or the applicable Accounting Standard), in accordance with the
applicable Accounting Standard. BeiGene will keep such books and records in
accordance with the record keeping requirements in Section 6.3 of Exhibit 2.8.

-47-

--------------------------------------------------------------------------------

(b)Audit Rights.  

(i)Each Party (the “Auditing Party”) shall have the right during the [* * *]
period described in Section 9.10(a) to (A) appoint at its expense an independent
certified public accountant of nationally recognized standing (the “Accounting
Firm”) reasonably acceptable to the other Party (the “Audited Party”) to audit
the relevant records of the Audited Party and its Affiliates to verify that the
amount of such payments were correctly determined and/or (B) require the Audited
Party to (1) appoint such an Accounting Firm to conduct such an audit of the
applicable sublicensee and (2) provide the results of such audit to the Auditing
Party. The Audited Party and its Affiliates shall each make its records
available for audit by the Accounting Firm during regular business hours at such
place or places where such records are customarily kept, upon reasonable notice
from the Auditing Party, solely to verify the payments hereunder were correctly
determined.  Such audit right shall not be exercised by the Auditing Party more
than once in any Calendar Year nor more than once with respect to sales of a
particular Licensed Product in a particular period and may cover a period ending
not more than [* * *] prior to the date of such request. All records made
available for audit pursuant to this Section 9.10(b) shall be deemed to be
Confidential Information of the Audited Party. The results of each audit, if
any, shall be binding on both Parties. If the amount of any payment hereunder
was underreported, the Audited Party shall promptly (but in any event no later
than [* * *] after its receipt of the Accounting Firm’s report so concluding)
make payment to the Auditing Party of the underreported amount.  The Auditing
Party shall bear the full cost of an audit that it conducts pursuant to this
Section 9.10(b) unless such audit discloses an under reporting by the Audited
Party of more than [* * *] of the aggregate amount of the payments hereunder
reportable in any Calendar Year, in which case the Audited Party shall reimburse
the Auditing Party for the reasonable audit fees for such audit, in addition to
paying the underreported amount.  

(ii)The Accounting Firm will disclose to the Auditing Party only whether the
payments or costs subject to such audit are correct or incorrect and the
specific details concerning any discrepancies.  No other information regarding
the results of such audit will be provided to the Auditing Party without the
prior consent of the Audited Party.  The Audited Party is entitled to require
the Accounting Firm to execute a reasonable confidentiality agreement prior to
commencing any such audit.  The Accounting Firm shall provide a copy of its
report and findings to the Audited Party.

9.11Taxes and Blocked Currency

(a)Taxes. Each Party shall be responsible for its own tax liabilities arising
under this Agreement.  Subject to this Section 9.11, AssemblyBio shall be liable
for all of its income and other taxes (including interest) (“Taxes”) imposed
upon any payments made by BeiGene to AssemblyBio under this Agreement
(“Agreement Payments”).  

(i)Tax Withholding. If Applicable Laws require the withholding of Taxes, BeiGene
shall make such withholding payments in a timely manner and shall subtract the
amount thereof from the Agreement Payments.  BeiGene shall promptly (as
available) submit to AssemblyBio appropriate proof of payment of the withheld
Taxes as well as the official receipts within a reasonable period of time.
BeiGene shall provide AssemblyBio reasonable assistance in order to allow
AssemblyBio to obtain the benefit of any present or future treaty against double
taxation or refund or reduction in Taxes which may apply to the Agreement
Payments. Without

-48-

--------------------------------------------------------------------------------

limiting the generality of the foregoing, if AssemblyBio is entitled under any
applicable tax treaty to a reduction of rate of, or the elimination of, or
recovery of, applicable withholding Taxes, it may deliver to BeiGene or the
appropriate Governmental Authority in the Territory the prescribed forms
necessary to reduce the applicable rate of withholding or to relieve BeiGene of
its obligation to withhold Taxes. In such case, BeiGene shall apply the reduced
rate of withholding, or not withhold, as the case may be, provided that BeiGene
is in receipt of evidence, in a form reasonably satisfactory to BeiGene (e.g.,
AssemblyBio’s delivery of all applicable documentation) prior to the time that
the applicable Agreement Payments are due.

(ii)Tax Cooperation. Each Party will provide the other with reasonable
assistance to enable the recovery, as permitted by Applicable Law, of
withholding Taxes, VAT, or similar obligations resulting from payments made
under this Agreement, such recovery to be for the benefit of the Party bearing
such withholding Tax or VAT.

(iii)Changes in Domicile. Notwithstanding anything to the contrary set forth in
this Agreement, if BeiGene assigns, transfers, or otherwise disposes of some or
all of its rights and obligations under this Agreement to any Person and if, as
a result of such action, the withholding or deduction of Tax required by
Applicable Law with respect to any Agreement Payment is increased, then (A) any
amount payable to AssemblyBio under this Agreement will be increased to take
into account such withheld Taxes as may be necessary so that, after making all
required withholdings (including withholdings on the withheld amounts),
AssemblyBio receives an amount equal to the sum it would have received had no
such withholding been made, and (B) AssemblyBio shall use Commercially
Reasonable Efforts to obtain a foreign Tax credit for U.S. corporate income Tax
purposes for any such additional amount paid pursuant to this sentence, upon the
receipt of which AssemblyBio will reimburse BeiGene for such additional amount
paid and credited within [* * *]. This Section 9.11(a)(iii) shall not apply to
the increased tax exposure caused by the following: (1) any Licensed Product is
being or will be Manufactured in the Territory pursuant to Section 7.2(d)(i) or
7.3; and (2) BeiGene assigns some or all of its rights and obligations under
this Agreement to a BeiGene Affiliate in China pursuant to Section 16.2, only to
the extent that BeiGene is unable to obtain Regulatory Approval in China that
would allow a BeiGene Affiliate outside of China to Commercialize the Licensed
Products in China despite the use of Commercially Reasonable Efforts to obtain
the same.

(b)Blocked Currency. If by Applicable Law in a region in the Territory,
conversion into USD or transfer of funds of a convertible currency to the United
States becomes materially restricted, forbidden or substantially delayed, then
BeiGene shall promptly notify AssemblyBio and, thereafter, amounts accrued in
such region under this Article 9 shall be paid to AssemblyBio (or its designee)
in such region in local currency by deposit in a local bank designated by
AssemblyBio and to the credit of AssemblyBio, unless the Parties otherwise
agree.    

Article 10

CONFIDENTIALITY

10.1Duty of Confidence. During the Term and for [* * *] thereafter, all
Confidential Information disclosed by a Disclosing Party to a Receiving Party
hereunder, including (a) with respect to BeiGene as Receiving Party, AssemblyBio
Know-How and (b) with respect to AssemblyBio as Receiving Party, any Know-How
within BeiGene IP, shall be maintained in confidence by the Receiving Party and
shall not be disclosed to any Third Party or used for any

-49-

--------------------------------------------------------------------------------

purpose, except as set forth herein, without the prior written consent of the
Disclosing Party; provided, however, that with respect to any Confidential
Information that is specifically identified at the time of disclosure to be a
trade secret under Applicable Laws, such obligations shall survive the
expiration of such [* * *] period for so long as such Confidential Information
remains a trade secret.  The Receiving Party may only use Confidential
Information of the Disclosing Party for purposes of exercising its rights and
fulfilling its obligations under this Agreement and may disclose Confidential
Information of the Disclosing Party and its Affiliates to employees, agents,
contractors, consultants and advisers of the recipient Party and its Affiliates,
licensees and sublicensees to the extent reasonably necessary for such purposes;
provided that such Persons are bound by confidentiality and non-use obligations
of the Confidential Information consistent with the confidentiality provisions
of this Agreement as they apply to the Receiving Party and that the Receiving
Party will remain fully responsible for any breach of the confidentiality or
non-use obligation by such Persons. Notwithstanding the foregoing, AssemblyBio
may disclose the terms of this Agreement, the Development Plans, records and
reports hereunder to IURTC to the extent required to comply with the terms and
conditions of the Upstream License, provided that other than with respect to the
terms of this Agreement and the exhibits hereto, AssemblyBio shall redact all
information not required to be provided to IURTC pursuant to the Upstream
License.

10.2Exceptions. The obligations under this Article 10 shall not apply to any
information to the extent the recipient Party can demonstrate by competent
evidence that such information:

(a)is (at the time of disclosure) or becomes (after the time of disclosure)
known to the public or part of the public domain through no breach of this
Agreement by the Receiving Party or its Affiliates;

(b)was known to, or was otherwise in the possession of, the Receiving Party or
its Affiliates, as evidenced by its written records, prior to the time of
disclosure by the Disclosing Party;

(c)is disclosed to the Receiving Party or an Affiliate on a non-confidential
basis by a Third Party that is entitled to disclose it without breaching any
confidentiality obligation to the Disclosing Party or any of its Affiliates; or

(d)is independently developed by or on behalf of the Receiving Party or its
Affiliates, as evidenced by its written records, without use of or reference to
the Confidential Information disclosed by the Disclosing Party or its Affiliates
under this Agreement.

10.3Authorized Disclosures. Subject to this Section 10.3 and Section 7 of
Exhibit 2.8, the Receiving Party may disclose Confidential Information belonging
to the other Party to the extent permitted as follows:

(a)such disclosure is deemed necessary by counsel to the Receiving Party to be
disclosed to such Receiving Party’s attorneys, independent accountants or
financial advisors for the sole purpose of enabling such attorneys, independent
accountants or financial advisors to provide advice to the Receiving Party, on
the condition that such attorneys, independent accountants and financial
advisors are bound by confidentiality and non-use obligations consistent with
the confidentiality provisions of this Agreement as they apply to the Receiving
Party;

-50-

--------------------------------------------------------------------------------

(b)disclosure by a Receiving Party or its Affiliates to governmental or other
regulatory agencies in order to obtain and maintain Patent Rights consistent
with Article 14;

(c)disclosure by a Receiving Party to any Affiliate, or to its or its
Affiliates’ employees, consultants, contractors, subcontractors, agents or
sublicensees on a need-to-know basis in order to enable such Receiving Party to
exercise its rights or to carry out its responsibilities under this Agreement,
including to any Third Party that is engaged by such Party to perform services
in connection with the Development, Manufacture and/or Commercialization of each
Licensed Compound and/or any Licensed Products in accordance with this
Agreement; provided, in each case, that such Persons are bound by
confidentiality and non-use obligations consistent with those contained in this
Agreement as they apply to the Receiving Party and that the Receiving Party will
remain fully responsible for the any breach of the confidentiality or non-use
obligation by such Persons;

(d)disclosure by BeiGene or a BeiGene Affiliate or sublicensee as reasonably
necessary to gain or maintain approval to conduct Clinical Trials for a Licensed
Product, to obtain and maintain any Regulatory Approval or Pricing and
Reimbursement Approval or to otherwise Develop, Manufacture and Commercialize
Licensed Products in the Territory, in accordance with this Agreement;

(e)disclosure by AssemblyBio or an AssemblyBio Affiliate or sublicensee as
reasonably necessary to gain or maintain approval to conduct Clinical Trials for
a Licensed Product, to obtain and maintain any Regulatory Approval or Pricing
and Reimbursement Approval or to otherwise Develop, Manufacture and
Commercialize Licensed Products outside the Territory;

(f)disclosure by a Party required in connection with any judicial or
administrative process relating to or arising from this Agreement (including any
enforcement hereof) or to comply with applicable court orders or governmental
regulations (or the rules of any recognized stock exchange or quotation system);

(g)disclosure by a Party to potential or actual investors or potential or actual
acquirers or actual or potential sublicensees in connection with due diligence
or similar investigations by such Third Parties; provided, in each case, that
any such potential or actual investor or acquirer or sublicensee agrees to be
bound by confidentiality and non-use obligations consistent with those contained
in this Agreement as they apply to the Receiving Party, and that the Receiving
Party will remain fully responsible for the any breach of the confidentiality or
non-use obligation by such Persons; or

(h)disclosure or publications permitted pursuant to the terms of Article 11.  

If the Receiving Party is required by judicial or administrative process to
disclose Confidential Information that is subject to the non-disclosure
provisions of this Article 10, such Receiving Party shall promptly inform the
Disclosing Party of the disclosure that is being sought in order to provide the
Disclosing Party an opportunity to challenge or limit the disclosure
obligations, and, if requested by the Disclosing Party, cooperate in all
reasonable respects with the Disclosing Party’s efforts to obtain confidential
treatment or a protective order with respect to any such disclosure, at the
Disclosing Party’s expense.  Confidential Information that is disclosed as
permitted by this Section 10.3 shall remain otherwise subject to the
confidentiality and non-use

-51-

--------------------------------------------------------------------------------

provisions of this Article 10, and the Party disclosing Confidential Information
as permitted by this Section 10.3 shall take all steps reasonably necessary,
including obtaining an order of confidentiality and otherwise cooperating with
the other Party, to ensure the continued confidential treatment of such
Confidential Information.

 

Article 11

PUBLICATIONS & PUBLICITY

11.1Publications.

(a)Prior to the issuance of any Publication contemplated by this Section 11.1,
the Parties will jointly develop a high-level global publication strategy
(“Global Publication Strategy”) to guide the Parties’ publications under this
Agreement.  The Global Publication Strategy shall be delivered to the JSC for
its review, discussion and approval.  Thereafter, either Party may propose any
amendments to the Global Publication Strategy, which amendments also shall be
delivered to the JSC for its review, discussion and approval. Prior to the
establishment of the Global Publication Strategy, each Party shall provide to
the other Party a copy of any proposed Publication for review and comment, to
the extent practicable and not causing any delays in the submission process of
such Publication.

(b)BeiGene acknowledges that some of the Clinical Trials are part of a
multi-center global study.  Accordingly and notwithstanding anything to the
contrary herein, BeiGene shall not publish or present the Clinical Trial
results, Clinical Data, non-clinical data or any associated results or
conclusions of any Clinical Trial from a Joint Global Study until after the
first publication or presentation regarding the overall global study is
completed by AssemblyBio, such publication to be at the sole discretion of
AssemblyBio.  Thereafter, BeiGene may publish or disclose such Clinical Data,
non-clinical data or any associated results or conclusions of any Joint Global
Study to the extent provided in, and in accordance with Section 11.1(c) and the
Global Publication Strategy.

(c) BeiGene may publicly present or publish any Clinical Data, non-clinical data
or any associated results or conclusions generated by or on behalf of BeiGene
pursuant to this Agreement solely to the extent that such data, results and
conclusions are specific to the Territory and the Field (each such proposed
presentation or publication, a “BeiGene Publication”), and subject to the
additional limitations set forth in this Article 11. In the event BeiGene
desires to publicly present or publish a BeiGene Publication in accordance with
the foregoing sentence, BeiGene shall provide AssemblyBio (including the
Alliance Manager and all AssemblyBio members of the JSC) with a copy of such
proposed BeiGene Publication at least [* * *] prior to the earlier of its
presentation or intended submission for publication; provided that in the case
of abstracts, this period shall be at least [* * *] (such applicable period, the
“Review Period”). BeiGene agrees that it will not submit or present any BeiGene
Publication (i) until AssemblyBio has provided written comments during such
Review Period on the material in such BeiGene Publication or (ii) until the
applicable Review Period has elapsed without written comments from AssemblyBio,
in which case BeiGene may proceed and the BeiGene Publication will be considered
approved in its entirety. If BeiGene receives written comments from AssemblyBio
during the applicable Review Period, it shall consider the comments of
AssemblyBio in good faith, but will retain the sole authority to submit the
manuscript for BeiGene Publication; provided that BeiGene agrees to (A) delete
any Confidential Information of AssemblyBio that AssemblyBio

-52-

--------------------------------------------------------------------------------

identifies for deletion in AssemblyBio’s written comments, (B) delete any
Clinical Data, non-clinical data results, conclusions or other related
information that is not specific to the Territory or the Field, or the
publication of which AssemblyBio reasonably determines, in its sole discretion,
would conflict with the Global Publication Strategy or materially and adversely
impact the Licensed Product, and (C) delay such BeiGene Publication for a period
of up to an additional [* * *] after the end of the applicable Review Period to
enable AssemblyBio to draft and file Patent Rights with respect to any subject
matter to be made public in such BeiGene Publication and to which AssemblyBio
has the applicable intellectual property rights to file such Patent Rights.
BeiGene shall provide AssemblyBio a copy of the BeiGene Publication at the time
of the submission or presentation. BeiGene agrees to acknowledge the
contributions of AssemblyBio, and the employees of AssemblyBio, in all BeiGene
Publications as scientifically appropriate. BeiGene shall require its
Affiliates, sublicensees and contractors to comply with the obligations of
Section 11.1.  

(d)Without limiting Section 11.1(a), AssemblyBio shall have the right to
publicly present or publish any Clinical Trial results or Clinical Data,
including non-clinical data or any results or conclusions associated therewith
(each such proposed presentation or publication, a “AssemblyBio Publication”
and, collectively with any BeiGene Publication, a “Publication”), and subject to
the limitations set forth in this Section 11.1(d) and in accordance with the
Global Publication Strategy. In the event AssemblyBio desires to publicly
present or publish a AssemblyBio Publication that includes data from a Clinical
Trial site in the Territory in accordance with the foregoing sentence,
AssemblyBio shall provide BeiGene (including the Alliance Manager and all
BeiGene members of the JSC) with a copy of such proposed AssemblyBio Publication
consistent with the applicable Review Period. AssemblyBio agrees that it will
not submit or present any AssemblyBio Publication (i) until BeiGene has provided
written comments during such Review Period on the material in such AssemblyBio
Publication or (ii) until the applicable Review Period has elapsed without
written comments from BeiGene, in which case AssemblyBio may proceed and the
AssemblyBio Publication will be considered approved in its entirety. If
AssemblyBio receives written comments from BeiGene during the applicable Review
Period, it shall consider the comments of BeiGene in good faith, but will retain
the sole authority to submit the manuscript for AssemblyBio Publication;
provided that AssemblyBio agrees to (A) delete any Confidential Information of
BeiGene that BeiGene identifies for deletion in BeiGene’s written comments and
(B) delay such AssemblyBio Publication for a period of up to an additional
[* * *] after the end of the applicable Review Period to enable BeiGene to draft
and file Patent Rights with respect to any subject matter to be made public in
such AssemblyBio Publication and to which BeiGene has the applicable
intellectual property rights to file such Patent Rights. AssemblyBio shall
provide BeiGene a copy of the AssemblyBio Publication at the time of the
submission or presentation. AssemblyBio agrees to acknowledge the contributions
of BeiGene, and the employees of BeiGene, in all AssemblyBio Publications as
scientifically appropriate. AssemblyBio shall require its Affiliates,
sublicensees and contractors to comply with the obligations of this Section
11.1(d).

11.2Attorney-Client Privilege.In the event of a dispute or potential dispute
where the Parties: (a) share a common legal and commercial interest in such
disclosure that is subject to attorney work product protections, attorney-client
privileges or similar protections and privileges; (b) are or may become joint
defendants in proceedings to which the information covered by such protections
and privileges relates; (c) intend that such privileges and protections remain
intact

-53-

--------------------------------------------------------------------------------

should either Party become subject to any actual or threatened proceeding to
which the Disclosing Party’s Confidential Information covered by such
protections and privileges relates; and (d) intend that both the Receiving Party
and the Disclosing Party will have the right to assert such protections and
privileges, the Parties may negotiate and enter into a common or joint defense
agreement.  Notwithstanding the foregoing, nothing in this Section 11.2 will
apply with respect to a Dispute between the Parties (including their respective
Affiliates).

11.3Publication and Listing of Clinical Trials. Each Party agrees to comply,
with respect to the listing of Clinical Trials or the publication of Clinical
Trial results with respect to Licensed Products and to the extent applicable to
its activities conducted under this Agreement, with (a) the Pharmaceutical
Research and Manufacturers of America (PhRMA) Guidelines on the listing of
Clinical Trials and the Publication of Clinical Trial results, and (b) any
Applicable Law or applicable court order, stipulations, consent agreements and
settlements entered into by such Party; provided that any listings or
publications made pursuant to this Section 11.3 shall be considered a
Publication hereunder and shall be subject to Section 11.1.

11.4Publicity.

(a)The Parties have mutually approved a joint press release attached hereto as
Exhibit 11.4 with respect to this Agreement and either Party may make subsequent
public disclosure of the contents of such press release.  Subject to the
foregoing, each Party agrees not to issue any press release or other public
statement, whether oral or written, disclosing the terms hereof or any of the
activities conducted hereunder without the prior written consent of the other
Party (such consent not to be unreasonably withheld, conditioned or delayed),
provided, however, that neither Party will be prevented from complying with any
duty of disclosure it may have pursuant to Applicable Laws or pursuant to the
rules of any recognized stock exchange or quotation system, subject to that
Party notifying the other Party of such duty and limiting such disclosure as
reasonably requested by the other Party (and giving the other Party sufficient
time to review and comment on any proposed disclosure).  

(b)Notwithstanding Section 11.4(a), AssemblyBio has the right to publicly
disclose (i) the achievement of material milestones under this Agreement; (ii)
to the extent required by Applicable Laws or by any Securities Regulator (as
defined below) and subject to AssemblyBio’s compliance with Section 11.4(c), the
amount of any payment received by AssemblyBio under this Agreement; (iii) the
commencement, completion, material data and key results of Clinical Trials
conducted under this Agreement; and (iv) any information relating to a Joint
Global Study. After a Publication has been made available to the public, each
Party may post such Publication or a link to it on its corporate web site
without the prior written consent of the other Party.

(c)The Parties hereby acknowledge and agree that either Party may be required by
Applicable Laws to submit a copy of this Agreement to the U.S. Securities and
Exchange Commission (the “SEC”) or any national or sub-national securities
regulatory body in any jurisdiction (collectively, the “Securities Regulators”).
If a Party is required by Applicable Laws to submit a description of the terms
of this Agreement to and/or file a copy of this Agreement with any Securities
Regulator, such Party agrees to consult and coordinate with the other Party with
respect to such disclosure and/or the preparation and submission of a
confidential treatment request for this Agreement.  Notwithstanding the
foregoing, if a Party is required by Applicable Laws to

-54-

--------------------------------------------------------------------------------

submit a description of the terms of this Agreement to or file a copy of this
Agreement with any Securities Regulator and such Party has (i) promptly notified
the other Party in writing of such requirement and any respective timing
constraints, (ii) provided copies of the proposed disclosure or filing to the
other Party reasonably in advance of such filing or other disclosure and (iii)
given the other Party a reasonable time under the circumstances to comment upon
and request confidential treatment for such disclosure, then such Party will
have the right to make such disclosure or filing at the time and in the manner
reasonably determined by its counsel to be required by Applicable Laws or the
applicable Securities Regulator.  If a Party seeks to make a disclosure or
filing as set forth in this Section 11.4(c) and the other Party provides
comments within the respective time periods or constraints specified herein, the
Party seeking to make such disclosure or filing will in good faith consider
incorporating such comments.

11.5Repeat Publicity and Publications. Notwithstanding anything to the contrary
in this Article 11, the contents of any press release or other publication that
has been reviewed and approved by a reviewing Party in accordance with this
Article 11 may be re-released by such reviewing Party or publishing Party
without a requirement for re-approval.

Article 12

REPRESENTATIONS, WARRANTIES, AND COVENANTS

12.1Representations, Warranties of Each Party. Each Party represents and
warrants to the other Party as of the Effective Date that:

(a)it is a corporation or limited company duly organized, validly existing, and
in good standing under the laws of the jurisdiction of formation;

(b)it has full corporate power and authority to execute, deliver, and perform
this Agreement, and has taken all corporate action required by Applicable Laws
and its organizational documents to authorize the execution and delivery of this
Agreement and the consummation of the transactions contemplated by this
Agreement;

(c)this Agreement constitutes a valid and binding agreement enforceable against
it in accordance with its terms (except as the enforceability thereof may be
limited by bankruptcy, bank moratorium or similar laws affecting creditors’
rights generally and laws restricting the availability of equitable remedies and
may be subject to general principles of equity whether or not such
enforceability is considered in a proceeding at law or in equity); and

(d)the execution and delivery of this Agreement and all other instruments and
documents required to be executed pursuant to this Agreement, and the
consummation of the transactions contemplated hereby do not and shall not (i)
conflict with or result in a breach of any provision of its organizational
documents, (ii) result in a breach of any agreement to which it is a party, or
(iii) violate any Applicable Laws.

-55-

--------------------------------------------------------------------------------

12.2Representations and Warranties of AssemblyBio.  AssemblyBio represents and
warrants to BeiGene as of the Effective Date that:

(a)Exhibit 12.2(a) sets forth a complete and accurate list of all AssemblyBio
Patent Rights Controlled by AssemblyBio as of the Effective Date that Cover the
Listed Compounds in the Territory (the “Scheduled Patent Rights”).

(b)AssemblyBio owns or is the exclusive licensee of all right, title, and
interest in and to the Scheduled Patent Rights;

(c)AssemblyBio has the right under the Scheduled Patent Rights to grant the
License to BeiGene, and it has not granted any license or other right under the
Scheduled Patent Rights that is inconsistent with the License;

(d)neither AssemblyBio nor any of its Affiliates has granted any mortgage,
pledge, claim, security interest, encumbrance, lien or other charge of any kind
on the Scheduled Patent Rights, and the Scheduled Patent Rights are free and
clear of any mortgage, pledge, claim, security interest, encumbrance, lien or
charge of any kind, in each case that would adversely affect the rights granted
to BeiGene herein;

(e)there are no claims, judgments or settlements against AssemblyBio pending, or
to AssemblyBio’s knowledge, threatened that invalidate or seek to invalidate any
Scheduled Patent Rights;

(f)AssemblyBio is not a party to any agreement with any governmental entity or
an agency thereof pursuant to which such governmental entity or such agency
provided funding for the development of any of the Scheduled Patent Rights and
which gives such governmental entity or such agency any rights to any Scheduled
Patent Rights that conflicts with, or limits the scope of, the License granted
to BeiGene hereunder;

(g)there is no pending litigation, nor has AssemblyBio received any written
notice from any Third Party, asserting or alleging that the Development,
Manufacture or Commercialization of the Licensed Product prior to the Effective
Date infringed or misappropriated the intellectual property rights of such Third
Party;

(h)to AssemblyBio’s knowledge, none of the Scheduled Patent Rights is the
subject of any interference proceeding, inter partes review or post-grant review
and there is no pending or threatened action, suit, proceeding or claim by a
Third Party challenging AssemblyBio’s ownership rights in, or the validity or
scope of, any Scheduled Patent Rights;

(i)there are no pending or, to its knowledge, no threatened (in writing),
adverse actions, suits or proceedings against AssemblyBio involving the
Scheduled Patent Rights or Licensed Product;

(j)to its knowledge, the AssemblyBio IP includes all Know-How Controlled by
AssemblyBio or its Affiliates that is necessary or reasonably useful to Develop,
Manufacture and Commercialize each Licensed Compound and/or Licensed Product in
the Field in the Territory

-56-

--------------------------------------------------------------------------------

as such Development, Manufacture and Commercialization is currently being
conducted by AssemblyBio;

(k)to its knowledge, AssemblyBio has complied with all Applicable Laws
applicable to (i) the prosecution and maintenance of the Scheduled Patent Rights
and (ii) its Development and Manufacture of Licensed Products in the Field;

(l)to its knowledge, there are no acts or omissions of AssemblyBio that would
constitute inequitable conduct, fraud, or misrepresentation to the applicable
patent office with respect to any Scheduled Patent Rights;

(m)except as set forth under Exhibit 12.2(m), (i) AssemblyBio has obtained, or
caused its Affiliates to obtain, assignments from the inventors of all rights
and embodiments in and to the Scheduled Patent Rights that are solely owned by
AssemblyBio or its Affiliates, (ii) to its knowledge, all such assignments are
valid and enforceable, and (iii) the inventorship of the Scheduled Patent Rights
that are solely owned by AssemblyBio or its Affiliates is properly identified on
each issued patent or patent application in such Scheduled Patent Rights;

(n)AssemblyBio and its Affiliates have used reasonable and diligent efforts
consistent with industry practices to protect the secrecy, confidentiality and
value of all AssemblyBio Know-How that constitutes trade secrets under
Applicable Laws;

(o)AssemblyBio has provided to BeiGene all material documentation, data, and
information under its control requested by BeiGene relating to each Licensed
Compound and the use thereof in the Field. Without limiting the foregoing,
AssemblyBio has provided to BeiGene complete and accurate copies of (i) all
existing material Regulatory Submissions made by AssemblyBio or its Affiliate in
the Territory or the United States (the “Existing Regulatory Materials”), and
(ii) all other material correspondence to/from any Regulatory Authority in the
Territory or the United States controlled by AssemblyBio, in each case related
to each Licensed Compound or any Licensed Product. Other than the Existing
Regulatory Materials, neither AssemblyBio nor any of its Affiliates has, as of
the Effective Date, obtained or filed any INDs or any other form of regulatory
application with Regulatory Approvals for marketing, for each Licensed Compound
or any Licensed Product in the Territory or the United States. The Existing
Regulatory Materials are, to the knowledge of AssemblyBio, in good standing, and
neither AssemblyBio nor any of its Affiliates has received any notice in writing
from any Regulatory Authority that the Existing Regulatory Materials are not
currently in, or may not remain in, good standing with the applicable Regulatory
Authority;

(p)AssemblyBio has provided to BeiGene all material adverse event information
with respect to each Licensed Compound or any Licensed Product known to
AssemblyBio or its Affiliates; and

(q)The Upstream License is the only agreement by and between AssemblyBio and any
Third Party that provides for the license to AssemblyBio of any Know-How or
Patent Rights that are included as part of the AssemblyBio IP. BeiGene
acknowledges that AssemblyBio has provided BeiGene with the copy of the Upstream
License prior to the Effective Date. Without limiting the generality of the
foregoing, the Upstream License is in full force and effect and is the valid and
binding obligation of AssemblyBio, enforceable in accordance with its terms, and
is

-57-

--------------------------------------------------------------------------------

binding on IURTC. AssemblyBio has not materially breached and is not currently
in material breach of its obligations under the Upstream License in a manner
that has, or would reasonably be expected to have, a material adverse effect on
the rights granted to BeiGene under this Agreement, and to AssemblyBio’s
knowledge, IURTC has not materially breached, and is not currently in material
breach of, its obligations under the Upstream License.

12.3Representations and Warranties of BeiGene. BeiGene represents and warrants
to AssemblyBio as of the Effective Date that:

(a)there are no legal claims, judgments or settlements against or owed by
BeiGene or any of its Affiliates, or pending or, to BeiGene’s knowledge,
threatened, legal claims or litigation, in each case, relating to antitrust,
anti-competition, anti-bribery or corruption violations;

(b)each of BeiGene and its Affiliates is not, and has not been, debarred or
disqualified by any Regulatory Authority; and none of BeiGene or its Affiliates’
employees or contractors who will be involved in the Development, Manufacture or
Commercialization of the Licensed Product are, or have been, debarred or
disqualified by any Regulatory Authority;

(c)BeiGene has sufficient financial wherewithal to (i) perform all of its
obligations pursuant to this Agreement, and (ii) meet all of its obligations
that come due in the ordinary course of business; and

(d)BeiGene has or can readily obtain sufficient technical, clinical, and
regulatory expertise to perform all of its obligations pursuant to this
Agreement, including its obligations relating to Development, manufacturing,
Commercialization, and obtaining Regulatory Approval.

12.4Covenants of BeiGene.  BeiGene covenants to AssemblyBio that:

(a)in the course of performing its obligations or exercising its rights under
this Agreement, BeiGene shall comply with all Applicable Laws, including, as
applicable, cGMP, GCP, and GLP standards;

(b)BeiGene will conduct its obligations with respect to the Global Development
Plan and the Territory Development Plan in strict adherence with the study
design set forth in the Global Development Plan and the Territory Development
Plan, as may be amended from time to time;

(c)BeiGene and its Affiliates will not employ any employees or use any
contractors in the Development, Manufacture or Commercialization of the Licensed
Product who are, or have been, debarred or disqualified by any Regulatory
Authority;

(d)BeiGene will only engage Clinical Trial sites under the Territory Development
Plan and the Global Development Plan that conduct all Clinical Trials in
compliance with Applicable Laws, including GCP and the ICH Guidelines, and are
approved by the applicable Regulatory Authority;

-58-

--------------------------------------------------------------------------------

(e)BeiGene and its Affiliates will obtain necessary consents, and sufficient
rights, title and interests in the Clinical Data and Regulatory Submissions to
grant the right of reference or other right of use to AssemblyBio under Sections
5.9 and 6.3;

(f)except as otherwise expressly permitted in this Agreement, commencing on the
Effective Date and continuing until the end of the Term, BeiGene and its
Affiliates will not (i) assign or otherwise transfer ownership of any BeiGene IP
or BeiGene Collaboration IP, except to the extent such assignment or transfer
does not conflict with or adversely affect any of the licenses granted to
AssemblyBio hereunder, or (ii) grant to any Third Party any license rights to
any BeiGene IP or BeiGene Collaboration IP in the Territory if such license
grant conflicts with any of the licenses granted to AssemblyBio hereunder;

(g)BeiGene shall comply with all Applicable Upstream License Provisions; and

(h)At such times as BeiGene is serving as regulatory agent pursuant to Section
6.1, (i) BeiGene or its Affiliate who will serve as AssemblyBio’s regulatory
agent in the Territory will at all times meet all qualification requirements
under Applicable Laws in all material respects to be AssemblyBio’s regulatory
agent in the Territory as contemplated by this Agreement, and (ii)  BeiGene will
promptly notify AssemblyBio (A) of any significant change to these qualification
requirements of which it becomes aware and (B) if BeiGene or its Affiliate may
not meet these requirements, upon receiving any notice from any Regulatory
Authority or Third Party indicating or otherwise becoming aware of such fact.

12.5Covenants of AssemblyBio. AssemblyBio covenants to BeiGene that:

(a)in the course of performing its obligations or exercising its rights under
this Agreement, AssemblyBio shall comply with all Applicable Laws, including, as
applicable, cGMP, GCP, and GLP standards;

(b)AssemblyBio will conduct its obligations with respect to the Global
Development Plan in strict adherence with the study design set forth in the
Global Development Plan, as may be amended from time to time;

(c)AssemblyBio will only engage Clinical Trial sites under the Global
Development Plan that conduct all Clinical Trials in compliance with Applicable
Laws, including GCP and the ICH Guidelines, and are approved by the applicable
Regulatory Authority;  

(d)AssemblyBio and its Affiliates will not employ any employees or use any
contractors in the Development or Manufacture of the Licensed Product who are,
or have been, debarred or disqualified by any Regulatory Authority;

(e)AssemblyBio and its Affiliates will obtain necessary consents, and sufficient
rights, title and interests in the Clinical Data and Regulatory Submissions to
grant the right of reference or other right of use to BeiGene under Sections 5.9
and 6.3;

(f)except as otherwise expressly permitted in this Agreement, commencing on the
Effective Date and continuing until the end of the Term, AssemblyBio and its
Affiliates will

-59-

--------------------------------------------------------------------------------

not (i) assign or otherwise transfer ownership of any AssemblyBio Patent Rights
or AssemblyBio Know-How in the Territory, except to the extent such assignment
or transfer does not conflict with or adversely affect any of the Licenses
granted to BeiGene hereunder, or (ii) grant to any Third Party any license
rights to any AssemblyBio Patent Rights or AssemblyBio Know-How in the Territory
if such license grant conflicts with any of the Licenses granted to BeiGene
hereunder;

(g) AssemblyBio and its Affiliates shall be responsible for any payments under
the Upstream License resulting from the Development, Manufacture, or
Commercialization of the Licensed Products in the Field in the Territory under
this Agreement; and

(h)AssemblyBio and its Affiliates shall remain in compliance with the Upstream
License and shall not terminate, amend, waive or otherwise modify (or consent to
any of the foregoing) its rights under the Upstream License in any manner that
would materially adversely affect the rights or License granted to BeiGene
hereunder or increase or generate any new payment obligation under the Upstream
License that would apply to BeiGene, without BeiGene’s express written consent.
If AssemblyBio or any of its Affiliates receives any notice or other
communication that IURTC intends to terminate the Upstream License or the
Upstream License otherwise terminates, then AssemblyBio shall provide a written
notice to BeiGene as soon as possible, and in any event no later than [* * *]
after receipt of such notice or communication or other termination, as
applicable.

12.6NO OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS Article 12, (A) NO
REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON
BEHALF OF ASSEMBLYBIO OR BEIGENE; AND (B) ALL OTHER CONDITIONS AND WARRANTIES
WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE EXPRESSLY EXCLUDED,
INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON-INFRINGEMENT.

12.7Compliance with Anti-Corruption Laws.

(a)Notwithstanding anything to the contrary in this Agreement, each Party
agrees, on behalf of itself, its Affiliates, and its and their officers,
directors, employees, authorized agents, representatives and consultants,
sublicensees and subcontractors (collectively, the “Representatives”) that:

(i)it and its Representatives shall not, in the performance of this Agreement,
perform any actions that are prohibited by local and other anti-corruption laws
(including the provisions of the United States Foreign Corrupt Practices Act and
equivalent Applicable Laws in the Territory, collectively “Anti-Corruption
Laws”) that may be applicable to one or both Parties;

(ii)it and its Representatives shall adhere to its own internal anti-corruption
policies and shall not, in the performance of this Agreement, directly or
indirectly, make any payment, or offer or transfer anything of value, or agree
or promise to make any payment or offer or transfer anything of value, to a
government official or government employee, to any political party or any
candidate for political office or to any other Third Party with the purpose of

-60-

--------------------------------------------------------------------------------

influencing decisions related to either Party or its business in a manner that
would violate Anti-Corruption Laws;

(iii)it and its Representatives shall not, directly or indirectly, solicit,
receive or agree to accept any payment of money or anything of value in
violation of the Anti-Corruption Laws;

(iv)it will (A) promptly provide written notice to the other Party of any
violations of Anti-Corruption Laws by such Party, its Affiliates or its and
their respective Representatives that are performing under of this Agreement of
which it becomes aware; and (B) upon the request of the other Party (which such
request may be made no more frequently than once per Calendar Year), verify in
writing that to the best of its knowledge, there have been no violations of
Anti-Corruption Laws by such Party, its Affiliates or its and their respective
Representatives that are performing under this Agreement, or shall provide
details of any exception to the foregoing; and

(v)it shall maintain records (financial and otherwise) and supporting
documentation related to the subject matter of this Agreement in order to
document or verify compliance with the provisions of this Section 12.7, and upon
request of the other Party, up to one time per Calendar Year and upon reasonable
advance notice, shall provide the other Party or its representative with access
to such records for purposes of verifying compliance with the provisions of this
Section 12.7.

(b)Each Party represents and warrants that, to its knowledge, neither such Party
nor any of its Representatives or other Third Parties acting on behalf of such
Party or any of its Affiliates:

(i)has taken any action in violation of any applicable Anti-Corruption Laws; or

(ii)has offered, paid, given, promised to pay or give, or authorized the payment
or gift of anything of value, directly or indirectly, to any Public Official,
for the purposes of:

(1)influencing any act or decision of any Public Official in his or her official
capacity;

(2)inducing such Public Official to do or omit to do any act in violation of his
or her lawful duty;

(3)securing any improper advantage; or

(4)inducing such Public Official to use his or her influence with a government,
governmental entity, or commercial enterprise owned or controlled by any
government (including state-owned or controlled veterinary, laboratory or
medical facilities) in obtaining or retaining any business whatsoever.

-61-

--------------------------------------------------------------------------------

(c)Each Party further represents and warrants that, as of the Effective Date,
none of its Representatives or agents acting on behalf of such Party or any of
its Affiliates, is a Public Official.

(d)For purposes of this Section 12.7, “Public Official” means (i) any officer,
employee or representative of any regional, federal, state, provincial, county
or municipal government or government department, agency or other division; (ii)
any officer, employee or representative of any commercial enterprise that is
owned or controlled by a government, including any state-owned or controlled
veterinary, laboratory or medical facility; (iii) any officer, employee or
representative of any public international organization, such as the African
Union, the International Monetary Fund, the United Nations or the World Bank;
(iv) candidates of political positions, officers or employees of political
parties, or individuals working for such officers or employees; and (v) any
person acting in an official capacity for any government or government entity,
enterprise or organization identified above.

-62-

--------------------------------------------------------------------------------

Article 13

INDEMNIFICATION

13.1Indemnification by BeiGene. BeiGene shall indemnify and hold harmless
AssemblyBio, its Affiliates, and their respective directors, officers,
employees, contractors, agents and assigns (individually and collectively, the
“AssemblyBio Indemnitee(s)”) from and against all losses, liabilities, damages
and expenses (including reasonable attorneys’ fees and costs) (individually and
collectively, “Losses”) incurred in connection with any claims, demands, actions
or other proceedings by any Third Party (individually and collectively,
“Claims”) to the extent arising from (a) the Development, Manufacture or
Commercialization of the Licensed Products by or on behalf of BeiGene or any of
its Affiliates or sublicensees, including product liability Claims, in the
Territory, (b) BeiGene’s actions (or omissions) in the performance of its
obligations with respect to Regulatory Approvals, Regulatory Submissions and
interactions with Regulatory Authorities, in each case as the authorized
regulatory agent of record for AssemblyBio in the Territory, (c) BeiGene’s
actions (or omissions) in the performance of its obligations with respect to
Regulatory Approvals, Regulatory Submissions and interactions with Regulatory
Authorities, in each case, with respect to the Licensed Products in the
Territory, (d) the gross negligence or willful misconduct of BeiGene or its
Affiliates or sublicensees, (e) BeiGene’s breach of any of its representations
or warranties made in or pursuant to this Agreement or any covenants or
obligations set forth in this Agreement, or (f) the failure of BeiGene or its
Affiliates or sublicensees to abide by any Applicable Laws, in each case of
clauses (a) through (f) above, except to the extent such Losses or Claims arise
out of an AssemblyBio Indemnitee’s gross negligence or willful misconduct,
breach of this Agreement, or material failure to abide by any Applicable Laws.

13.2Indemnification by AssemblyBio. AssemblyBio shall indemnify and hold
harmless BeiGene, its Affiliates, and their directors, officers, employees,
contractors, agents and assigns (individually and collectively, the “BeiGene
Indemnitee(s)”) from and against all Losses incurred in connection with Claims
against such BeiGene Indemnitee to the extent arising from (a) the Development,
Manufacture or Commercialization of the Licensed Products by or on behalf of
AssemblyBio or any of its Affiliates or sublicensees (not including BeiGene or
its Affiliates or sublicensees), including product liability Claims, outside the
Territory, (b) the Development or Manufacture of the Licensed Products by or on
behalf of AssemblyBio or any of its Affiliates or sublicensees (not including
BeiGene or its Affiliates or sublicensees) in the Territory as contemplated by
this Agreement, (c) AssemblyBio’s actions (or omissions) in the performance of
its obligations with respect to Regulatory Approvals, Regulatory Submissions and
interactions with Regulatory Authorities, in any case, with respect to the
Licensed Products, (d) the gross negligence or willful misconduct of AssemblyBio
or its Affiliates hereunder, (e) AssemblyBio’s breach of any of its
representations or warranties made in or pursuant to this Agreement or any
covenants or obligations set forth in this Agreement, or (f) failure of
AssemblyBio or its Affiliates to abide by any Applicable Laws in its performance
hereunder, in each case of clauses (a) through (f) above, except to the extent
such Losses or Claims arise out of any of a BeiGene Indemnitee’s gross
negligence or willful misconduct, breach of this Agreement or material failure
to abide by any Applicable Laws.

13.3Indemnification Procedure. If either Party is seeking indemnification under
Sections 13.1 or 13.2 (the “Indemnified Party”), it shall inform the other Party
(the “Indemnifying Party”) of the Claim giving rise to the obligation to
indemnify pursuant to such Section within [* * *] after receiving written notice
of the Claim (it being understood and agreed,

-63-

--------------------------------------------------------------------------------

however, that the failure or delay by an Indemnified Party to give such notice
of a Claim shall not affect the indemnification provided hereunder except to the
extent the Indemnifying Party shall have been actually and materially prejudiced
as a result of such failure or delay to give notice). The Indemnifying Party
shall have the right to assume the defense of any such Claim for which it is
obligated to indemnify the Indemnified Party. The Indemnified Party shall
cooperate with the Indemnifying Party and the Indemnifying Party’s insurer as
the Indemnifying Party may reasonably request, and at the Indemnifying Party’s
cost and expense. The Indemnified Party shall have the right to participate, at
its own expense and with counsel of its choice, in the defense of any Claim that
has been assumed by the Indemnifying Party. Neither Party shall have the
obligation to indemnify the other Party in connection with any settlement made
without the Indemnifying Party’s written consent, which consent shall not be
unreasonably withheld, conditioned or delayed. The Indemnifying Party will not
admit liability of the Indemnified Party or otherwise enter into a settlement
adverse to the interest of the Indemnified Party without the Indemnified Party’s
prior written consent, which consent will not be unreasonably withheld,
conditioned, or delayed. If the Parties cannot agree as to the application of
Section 13.1 or 13.2 as to any Claim, pending resolution of the dispute pursuant
to Section 16.6, the Parties may conduct separate defenses of such Claims, with
each Party retaining the right to Claim indemnification from the other Party in
accordance with Section 13.1 or 13.2 upon resolution of the underlying Claim.

13.4Mitigation of Loss. Each Indemnified Party shall take and shall procure that
its Affiliates take all such reasonable steps and action as are reasonably
necessary in order to mitigate any Losses (or potential losses or damages) under
this Article 13. Nothing in this Agreement shall or shall be deemed to relieve
any Party of any common law or other duty to mitigate any losses incurred by it.

13.5Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
SECTION 13.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 13.1 OR 13.2, OR DAMAGES
AVAILABLE FOR A PARTY’S BREACH OF ITS OBLIGATIONS HEREUNDER RELATING TO
CONFIDENTIALITY OR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER SECTIONS 2.6 and
2.7.

13.6Insurance. Each Party shall procure and maintain insurance, including
product liability insurance, with respect to its activities hereunder and which
is consistent with normal business practices of prudent companies similarly
situated at all times during which any Licensed Product is being clinically
tested in human subjects or commercially distributed or sold in the Territory
and/or outside of the Territory and the requirements set forth in Section 12 of
Exhibit 2.8. All such insurance coverage may be maintained through a
self-insurance plan that substantially complies with the foregoing limits and
requirements and may be satisfied through one or more policies, including an
umbrella policy; provided, however, that the other Party will provide to the
requesting Party a letter(s) affirming appropriate self-insurance and/or a
certificate of insurance evidencing such coverage in accordance with this
Agreement. Each Party will maintain such insurance or self-insurance coverage
without interruption during the Term and for a period of [* * *]

-64-

--------------------------------------------------------------------------------

thereafter, and, if applicable, will provide certificates and/or letters
evidencing such insurance coverage without interruption as reasonably requested
during the period of time for which such coverage must be maintained. Each Party
will be provided at least [* * *] prior written notice of any cancellation or
material decrease in the other Party’s insurance coverage limits described
above. Notwithstanding the foregoing, either Party’s failure to maintain
adequate insurance will not relieve that Party of its obligations set forth in
this Agreement.

Article 14

INTELLECTUAL PROPERTY

14.1Inventions.

(a)Ownership. As between the Parties, (i) AssemblyBio shall solely own all
AssemblyBio IP and Product-Specific IP, (ii) BeiGene shall solely own all
BeiGene IP, and (iii) the ownership of any other Invention shall be determined
by inventorship in accordance with the United States patent law. Accordingly,
except as otherwise provided in this Section 14.1(a), (A) Inventions that are
made solely by or on behalf of AssemblyBio and its Affiliates (and all
intellectual property rights therein, including the Patent Rights claiming them)
shall be owned solely by AssemblyBio (“AssemblyBio Collaboration IP”); (B)
Inventions that are made solely by BeiGene (and all intellectual property rights
therein, including the Patent Rights claiming them, except any Product-Specific
IP) shall be owned solely by BeiGene (“BeiGene Collaboration IP”); and (C)
Inventions that are made jointly by the Parties (and all intellectual property
rights therein, including the Patent Rights claiming them) shall be owned
jointly by the Parties (“Joint Collaboration IP”).  Product-Specific IP shall be
included in the AssemblyBio IP and licensed to BeiGene in the Field in the
Territory under Section 2.1.

(b)Disclosure. Each Party shall promptly disclose to the other Party all
Inventions, including all invention disclosures or other similar documents
submitted to such Party by its or its Affiliates’ employees, agents, or
independent contractors relating thereto, and shall also promptly respond to
reasonable requests from the other Party for additional information relating
thereto.

(c)Assignment; Jointly-Owned Inventions.

(i)BeiGene shall assign and hereby does assign to AssemblyBio all right, title
and interest in and to all Product-Specific IP. BeiGene shall take (and cause
its Affiliates, sublicensees and their employees, agents, and contractors to
take) such further actions reasonably requested by AssemblyBio to evidence such
assignment and to assist AssemblyBio in obtaining patent and other intellectual
property rights protection for the Product-Specific IP. BeiGene shall obligate
its Affiliates, sublicensees and contractors to assign all Product-Specific IP
to BeiGene (or directly to AssemblyBio), so that BeiGene can comply with its
obligations under this Section 14.1, and BeiGene shall promptly obtain such
assignment.

(ii)Subject to the rights granted under and the restrictions set forth in this
Agreement, it is understood that neither Party shall have any obligation to
account to the other Party for profits, or to obtain any approval of the other
Party to license, assign or otherwise exploit any Joint Collaboration IP (or any
Patent Rights claiming the same, “Joint Patent Rights”), by

-65-

--------------------------------------------------------------------------------

reason of joint ownership thereof, and each Party hereby waives any right it may
have under the Applicable Law of any jurisdiction to require any such approval
or accounting.

14.2Patent Prosecution.

(a)AssemblyBio Patent Rights.

(i)Subject to Section 14.2(c), as between the Parties, AssemblyBio shall have
the right to control the Patent Prosecution of all AssemblyBio Patent Rights
[* * *].  

(ii)AssemblyBio shall (A) provide BeiGene with a reasonable opportunity to
consult with AssemblyBio regarding such AssemblyBio Patent Rights in the
Territory, and any amendment, submission or response with respect to such
AssemblyBio Patent Rights and keep BeiGene reasonably informed of the Patent
Prosecution of the AssemblyBio Patent Rights and (B) provide BeiGene with all
material correspondence received from any patent authority in connection
therewith in sufficient time to allow for review and comment by BeiGene.
Further, AssemblyBio shall notify BeiGene of any decision to cease Patent
Prosecution or maintenance of any AssemblyBio Patent Rights in the Territory.
AssemblyBio will consider BeiGene’s comments on Patent Prosecution in good faith
but will have final decision-making authority under this Section 14.2(a)(ii).

(b)BeiGene Patent Rights. As between the Parties, BeiGene shall have the sole
right to control the Patent Prosecution of all BeiGene Patent Rights throughout
the world, [* * *].

(c)Joint Patent Rights. In the event that any jointly-owned Invention is created
hereunder, at either Party’s request, the Parties shall discuss a mutually
acceptable filing and prosecution strategy for any Joint Patent Rights; provided
that absent such agreement, AssemblyBio shall control the Patent Prosecution of
any Joint Patent Rights, as set forth in this Section 14.2(c). Unless the
Parties agree in writing on an alternative arrangement, AssemblyBio shall
[* * *] of Patent Prosecution of Joint Patent Rights. AssemblyBio shall (i)
provide BeiGene with an opportunity to consult with AssemblyBio regarding such
Joint Patent Rights, and any amendment, submission or response with respect to
such Joint Patent Rights and keep BeiGene reasonably informed of the Patent
Prosecution of the Joint Patent Rights, and (ii) provide BeiGene with all
material correspondence received from any patent authority in connection
therewith in sufficient time to allow for review and comment by
BeiGene.  Further, AssemblyBio shall notify BeiGene of any decision to cease
Patent Prosecution of any Joint Patent Rights. AssemblyBio will consider
BeiGene’s comments on Patent Prosecution in good faith but will have final
decision-making authority under this Section 14.2(c).

(d)Cooperation. Each Party shall provide the other Party all reasonable
assistance and cooperation in the Patent Prosecution efforts under this Section
14.2, including providing any necessary powers of attorney and executing any
other required documents or instruments for such prosecution.

(e)Abandonment. If AssemblyBio decides to cease the Patent Prosecution, or to
allow to lapse, any AssemblyBio Patent Rights in the Territory or any Joint
Patent Rights, AssemblyBio shall inform BeiGene of such decision promptly and,
in any event, so as to provide

-66-

--------------------------------------------------------------------------------

BeiGene a reasonable amount of time to meet any applicable deadline to establish
or preserve such Patent Rights in such country or region.  BeiGene shall have
the right, but not the obligation, to assume responsibility for continuing the
Patent Prosecution of such Patent Rights in AssemblyBio’s name (or both Parties’
names, with respect to Joint Patent Rights), [* * *], through patent counsel or
agents of its choice and, to the extent that BeiGene assumes such
responsibility, AssemblyBio shall promptly deliver to BeiGene copies of all
necessary files related to any Patent Rights with respect to which
responsibility has been transferred and shall take all actions and execute all
documents reasonably necessary for BeiGene to assume such Patent Prosecution
activities, [* * *].

14.3Patent Enforcement.

(a)Notice. Each Party shall notify the other within [* * *] of becoming aware of
any alleged or threatened infringement by a Third Party of (i) any of the
Scheduled Patent Rights or Joint Patent Rights in the Territory or (ii) any of
the BeiGene Patent Rights in the Territory, which infringement of such BeiGene
Patent Rights adversely affects or is reasonably expected to adversely affect
any Licensed Product in the Field in the Territory, and, in each case, any
related declaratory judgment or equivalent action alleging the invalidity,
unenforceability or non-infringement of any such Patent Rights (collectively
“Product Infringement”). Each Party shall also notify the other within [* * *]
of becoming aware of any alleged or threatened infringement by a Third Party of
any Patent Rights that claims BeiGene Collaboration IP (“BeiGene Collaboration
Patent Rights”), which infringement adversely affects or is reasonably expected
to adversely affect any Licensed Product outside of the Territory, including any
related declaratory judgment or equivalent action alleging the invalidity,
unenforceability or non-infringement of any such Patent Rights (an “Ex-Territory
Infringement”). For clarity, Product Infringement and Ex-Territory Infringement,
in each case, exclude any adversarial Patent Prosecution proceedings.

(b)Enforcement Rights.

(i)BeiGene shall have the first right to bring and control any legal action to
enforce Scheduled Patent Rights and any substitutions, continuations,
continuations-in-part, continued prosecution applications including requests for
continued examination, divisional applications and renewals, and all letters
patent or certificates of invention granted thereon, and all reissues,
reexaminations, extensions (including pediatric exclusivity patent extensions),
term restorations, renewals, substitutions, confirmations, registrations,
revalidations, revisions and additions of or to any of the foregoing, in each
case, in the Territory, or Joint Patent Rights (cumulatively, the “Enforceable
Patent Rights”) against any Product Infringement in the Territory at its sole
expense as it reasonably determines appropriate, and BeiGene shall consider in
good faith the interests of AssemblyBio in such enforcement of the Enforceable
Patent Rights; provided that: (A) BeiGene shall keep AssemblyBio reasonably
informed about such enforcement; (B) BeiGene shall not take any position with
respect to, or compromise or settle, any such Product Infringement in any way
that materially and adversely affects the scope, validity or enforceability of
any Enforceable Patent Rights, without the prior consent of AssemblyBio, which
consent shall not be unreasonably withheld, delayed or conditioned; and (C) if
BeiGene does not intend to prosecute or defend a Product Infringement, or ceases
to diligently pursue an enforcement with respect to such a Product Infringement,
it shall promptly inform AssemblyBio in such a manner that such enforcement will
not be prejudiced and Section 14.3(b)(ii) shall apply.

-67-

--------------------------------------------------------------------------------

(ii)If BeiGene or its designee fails to abate such Product Infringement in the
Territory or to file an action to abate such Product Infringement in the
Territory within [* * *] after becoming aware of such Product Infringement, or
if BeiGene discontinues the prosecution of any such action after filing without
abating such Product Infringement, then AssemblyBio shall have the right to
enforce the Enforceable Patent Rights, as applicable, against such Product
Infringement in the Territory at its sole expense as it reasonably determines
appropriate and shall keep BeiGene reasonably informed with respect to any such
enforcement action; provided that (A) if BeiGene provides a reasonable rationale
for not pursuing or continuing to pursue such Product Infringement (including a
substantive concern regarding counter-claims by the infringing Third Party),
AssemblyBio shall not pursue any action against such Product Infringement, and
BeiGene and AssemblyBio shall discuss in good faith whether to consider the
appropriate steps to be taken to address BeiGene’s concerns as well as the
effect of such Product Infringement on BeiGene and (B) AssemblyBio shall not
enter into any settlement admitting the invalidity of, or otherwise impairing,
any Enforceable Patent Rights in the Territory without the prior written consent
of BeiGene, which consent shall not be unreasonably withheld, delayed or
conditioned.

(iii)BeiGene shall have the sole right to bring and control any legal action to
enforce BeiGene Patent Rights against any Product Infringement in the Territory
at its sole expense as it reasonably determines appropriate, and shall keep
AssemblyBio reasonably informed with respect to any such legal action. BeiGene
shall not have the right to enforce any AssemblyBio Patent Rights outside of the
Territory.

(iv)BeiGene shall have the first right to bring and control any legal action to
enforce any BeiGene Collaboration Patent Rights against any Ex-Territory
Infringement outside of the Territory at its sole expense as it reasonably
determines appropriate, and BeiGene shall consider in good faith the interests
of AssemblyBio in such enforcement of the BeiGene Collaboration Patent Rights.
If BeiGene or its designee fails to abate such Ex-Territory Infringement outside
of the Territory or to file an action to abate such Ex-Territory Infringement
outside of the Territory within [* * *] after a written request from AssemblyBio
to do so, or if BeiGene discontinues the prosecution of any such action after
filing without abating such infringement, then AssemblyBio shall have the right
to enforce such BeiGene Collaboration Patent Rights against such Ex-Territory
Infringement outside the Territory at its own expense as it reasonably
determines appropriate; provided that (A) if BeiGene provides a reasonable
rationale for not pursuing or continuing to pursue such Ex-Territory
Infringement (including a substantive concern regarding counter-claims by the
infringing Third Party), AssemblyBio shall not pursue any action against such
Product Infringement, and BeiGene and AssemblyBio shall discuss in good faith
whether to consider the appropriate steps to be taken to address BeiGene’s
concerns and (B) AssemblyBio shall not enter into any settlement admitting the
invalidity of, or otherwise impairing, any BeiGene Collaboration Patent Rights
without the prior written consent of BeiGene which consent shall not be
unreasonably withheld, delayed or conditioned.

(c)Cooperation. At the request of the Party bringing an action related to
Product Infringement or Ex-Territory Infringement, the other Party shall provide
reasonable assistance in connection therewith, including by executing reasonably
appropriate documents, cooperating in discovery and joining as a party to the
action if required by Applicable Laws to pursue such action, at each such
Party’s sole cost and expense.

-68-

--------------------------------------------------------------------------------

(d)Recoveries. Any recoveries resulting from an enforcement action relating to a
claim of Product Infringement in the Territory or an Ex-Territory Infringement
will first be applied to costs and expenses incurred by each Party in connection
with such action (including, for this purpose, a reasonable allocation of
expenses of internal counsel) (provided that if the amount of such recovery is
not sufficient to cover all such costs and expenses of each Party, then the
amount of the recovery will be proportionately shared by the Parties based on
the amount of such costs and expenses incurred by each Party); and with respect
to any remaining proceeds, (i) the Parties shall negotiate in good faith an
appropriate allocation of such remaining proceeds to reflect the economic
interests of the Parties under this Agreement with respect to such Product
Infringement and (ii) unless otherwise agreed in subsection (i), [* * *] of such
remaining proceeds will be allocated to the enforcing Party and [* * *] of such
remaining proceeds will be allocated to the non-enforcing Party.

14.4Infringement of Third Party Rights.

(a)Notice. If any Licensed Product used or sold by BeiGene, its Affiliates or
sublicensees becomes the subject of a Third Party’s claim or assertion of
infringement of any Patent Rights or other intellectual property rights in the
Territory that are owned or controlled by such Third Party, BeiGene shall
promptly notify AssemblyBio within [* * *] after receipt of such claim or
assertion and such notice shall include a copy of any summons or complaint (or
the equivalent thereof), including, if applicable, a certified translation into
English, received regarding the foregoing. Thereafter, the Parties shall
promptly meet to consider the claim or assertion and the appropriate course of
action and may, if appropriate, agree on and enter into a “common interest
agreement” wherein the Parties agree to their shared, mutual interest in the
outcome of such potential dispute. The Parties shall assert and not waive the
joint defense privilege with respect to any communications between the Parties
in connection with the defense of such claim or assertion.

(b)Defense. In the event that a claim is brought against either Party alleging
the infringement, violation or misappropriation of any Third Party intellectual
property right based on the Manufacture, use, sale or importation of the
Licensed Products in the Field in the Territory, the Parties shall promptly meet
to discuss the defense of such claim, and the Parties shall, as appropriate,
enter into a joint defense agreement with respect to the common interest
privilege protecting communications regarding such claim in a form reasonably
acceptable to the Parties; provided, that, unless otherwise agreed by the
Parties, BeiGene will have the first right, but not the obligation, to defend
and dispose (including through settlement or license) such claim; provided that
(i) BeiGene will discuss in good faith and coordinate with AssemblyBio in
connection therewith and BeiGene will consider in good faith and reasonably
address AssemblyBio’s input and comments with respect thereto and (ii) BeiGene
will not, without the consent of AssemblyBio, enter into any such settlement,
consent judgment or other disposition of any action or proceeding that would (A)
impose any liability or obligation on AssemblyBio, (B) include the grant of any
license, covenant or other rights to any Third Party that would conflict with or
reduce the scope of the rights of AssemblyBio with respect to the Licensed
Products outside of the Territory or with respect to the AssemblyBio IP, or (C)
otherwise adversely affect the rights of AssemblyBio with respect to the
Licensed Products outside of the Territory or with respect to the AssemblyBio
IP. BeiGene will keep AssemblyBio informed on the status of such defense action,
and AssemblyBio will have the right, but not the obligation, to participate and
be separately represented in such defense action at its sole option and at its
own expense. In the event BeiGene fails to use Commercially Reasonable Efforts

-69-

--------------------------------------------------------------------------------

to resolve such Third Party claims, AssemblyBio shall have the right to assume
the defense of such claims.

14.5Third Party In-License. In the event either Party reasonably determines that
any Patent Rights owned or controlled by a Third Party are necessary for the
Development or Commercialization of the Licensed Product in the Field in the
Territory, such Party will so notify the other Party, and shall provide the
other Party with the opportunity to review and comment on (a) such Patent Rights
as identified as necessary, and (b) the proposed terms and conditions of a
license agreement with such Third Party for such Patent Rights (a “Third Party
License”), and such Party shall consider in good faith any comments received
from the other Party. If such Party enters into such Third Party License with
the applicable Third Party, such Party will provide the other Party with a true
and complete copy of such Third Party License within [* * *] following the
execution thereof.  In the event AssemblyBio enters into such Third Party
License, BeiGene shall [* * *]. In the event BeiGene enters into such Third
Party License, BeiGene shall [* * *].

14.6In-Licensed Patent Rights. Each Party’s rights under this Article 14 with
respect to the prosecution and enforcement of any In-Licensed Patent Rights
shall be subject to the rights of IUTRC under the Upstream License to prosecute
and enforce such Patent Rights that are set forth on Exhibit 14.6.  

14.7Patent Term Extensions. BeiGene will reasonably cooperate with AssemblyBio,
including providing reasonable assistance to AssemblyBio in its efforts to seek
and obtain patent term restoration or supplemental protection certificates or
the like or their equivalents in any region in the Territory, where applicable
to AssemblyBio Patent Rights, including as may be available to the Parties under
the provisions of the U.S. Drug Price Competition and Patent Term Restoration
Act of 1984 or comparable laws outside the United States of America, in each
case, in connection with any Licensed Product. Notwithstanding anything to the
contrary contained herein, if elections with respect to obtaining such patent
term restoration or supplemental protection certificates or the like or their
equivalents in the Territory are to be made in connection therewith, the Parties
will mutually agree upon the election. The requirements of Section 9.7 of
Exhibit 2.8 shall also apply to this Agreement.

14.8Product Trademarks. Subject to Section 8.4(c), BeiGene shall have the right
to brand Licensed Products in the Territory using trademarks, logos, and trade
names it determines appropriate for such Licensed Products, which may vary by
region or within a region (the “Product Marks”); provided, however, that BeiGene
shall not (a) use any trademarks or house marks of AssemblyBio (including
AssemblyBio’s corporate name) or any trademark confusingly similar thereto, or
(b) any trademarks or house marks that are inconsistent with the Global Brand
Elements, in both cases (a) and (b), without AssemblyBio’s prior written
consent. BeiGene shall own all rights in the Product Marks in the Territory
(excluding any such marks that include, in whole or part, any corporate name or
logos of AssemblyBio or its Affiliates or sublicensees) and shall register and
maintain the Product Marks in the Territory that it determines reasonably
necessary, at BeiGene’s cost and expense.

14.9Patent Marking. BeiGene shall mark all Licensed Products in accordance with
Applicable Laws, including the applicable patent marking laws, and shall require
all of its Affiliates and sublicensees to do the same. To the extent permitted
by Applicable Laws, BeiGene

-70-

--------------------------------------------------------------------------------

shall indicate on the product packaging, advertisement and promotional materials
that such Licensed Product is in-licensed from AssemblyBio.

Article 15

TERM AND TERMINATION

15.1Term.  This Agreement shall be effective as of the Effective Date, and shall
continue, on a region-by-region and Licensed Product-by-Licensed Product basis,
in effect until the expiration of the Royalty Term applicable to such Licensed
Product in such region (the “Term”). On a region-by-region and Licensed
Product-by-Licensed Product basis, upon the natural expiration of the Term as
contemplated in this Section 15.1, the License in such region shall become fully
paid-up, royalty-free, perpetual, irrevocable and non-exclusive; provided, that,
any remaining Development Milestone Events or Commercialization Milestones
Events that are achieved with respect to a Licensed Product after such
expiration shall be and remain subject to BeiGene’s obligation to pay the
corresponding Development Milestone Payments or Commercialization Milestone
Payments (as applicable) in accordance with Sections 9.2 and 9.3, which shall
survive such expiration.

15.2Termination

(a)Termination by BeiGene for Convenience. At any time, BeiGene may terminate
this Agreement by providing written notice of termination to AssemblyBio, which
termination is effective ninety (90) days after the date of the notice.

(b)Termination upon BeiGene Election. This Agreement will terminate on a
Licensed Compound-by-Licensed Compound basis with respect to ABI-H2158 or
ABI-H3733, and such Licensed Compound’s corresponding Licensed Products, upon
written notice by BeiGene of termination to AssemblyBio after the process
outlined under Section 5.2(d).

(c)Termination for Material Breach.

(i)If either BeiGene or AssemblyBio is in material breach of any obligation
hereunder, the non-breaching Party may give notice to the breaching Party
specifying the claimed particulars of such breach (a “Breach Notification”).  If
the Party receiving a Breach Notification fails to cure, or fails to dispute,
that material breach on or before [* * *] from the date of the Breach
Notification, the Party delivering the Breach Notification may terminate this
Agreement.

(ii)If the allegedly breaching Party disputes in good faith the existence,
materiality, or cure of the applicable material breach and provides written
notice of such dispute to the other Party within the [* * *] period set forth
above, then the matter will be addressed under the dispute resolution provisions
in Section 16.6 and the termination will not become effective unless and until
it has been determined under Section 16.6 that the allegedly breaching Party is
in material breach of any of its obligations under this Agreement and has failed
to cure the same.  During the pendency of such a dispute, all of the terms of
this Agreement will remain in effect and the Parties will continue to perform
all of their respective obligations hereunder.

-71-

--------------------------------------------------------------------------------

(d)Termination for Patent Challenge. Notwithstanding anything herein to the
contrary, in the event that BeiGene or its Affiliates file or initiate an action
challenging (directly or indirectly (e.g., through a Third Party)) in a court or
by administrative proceeding seeking the invalidity or unenforceability or
seeking to limit the scope of any Scheduled Patent Rights (or their respective
counterpart Patent Rights in other jurisdictions), then AssemblyBio, at its
discretion, may give notice to BeiGene that AssemblyBio will terminate the
License granted to BeiGene under Section 2.1 unless such challenge is withdrawn,
abandoned, or terminated (as appropriate) within [* * *] from the date of such
notice. In the event that BeiGene or its Affiliate (as the case may be) does not
withdraw, abandon or terminate (as appropriate) such challenge within such
[* * *] period, AssemblyBio may terminate this Agreement, and BeiGene shall
cease all Development and Commercialization of the Licensed Products. For
clarity, this Section 15.2(d) does not apply to any counterclaim filed by
BeiGene or its Affiliates or sublicensees as defendant in any Scheduled Patent
Rights (or their respective counterpart Patent Rights in other jurisdictions)
infringement cause of action filed or initiated by AssemblyBio or its Affiliates
with respect to a Licensed Product or activities under this Agreement.

(e)Termination for Insolvency. Each Party shall have the right to terminate this
Agreement upon delivery of written notice to the other Party in the event that
(i) such other Party files in any court or agency pursuant to any statute or
regulation of any jurisdiction a petition in bankruptcy or insolvency or for
reorganization or similar arrangement for the benefit of creditors or for the
appointment of a receiver or trustee of such other Party or its assets,
(ii) such other Party is served with an involuntary petition against it in any
insolvency proceeding and such involuntary petition has not been stayed or
dismissed within [* * *] of its filing, or (iii) such other Party makes an
assignment of substantially all of its assets for the benefit of its creditors.

(f)Full Force and Effect During Notice Period. This Agreement shall remain in
full force and effect until the expiration of the applicable termination notice
period. For clarity, if any milestone event is achieved or royalty payments
become payable under Article 9 during the termination notice period, the
corresponding milestone payment or royalty payment, as applicable, is accrued
and BeiGene shall remain responsible for the payment of such milestone payment
or royalty payment, as applicable, even if the due date of such milestone
payment or royalty payment, as applicable, may come after the effective date of
the termination.

15.3Effect of Termination. Except as provided in Section 15.4, if this Agreement
is terminated (including due to the exercise of BeiGene Election pursuant to
Section 5.2(d)(ii)) the following shall apply:

(a)License Grant to BeiGene. The License and all other rights granted by
AssemblyBio to BeiGene under the AssemblyBio IP pursuant to this Agreement
(including any sublicense with respect to the In-Licensed Patent Rights) shall
terminate.

(b)  License Grants to AssemblyBio.  The licenses granted by BeiGene to
AssemblyBio pursuant to Section 2.4 shall continue following the effective date
of termination and will become a worldwide license.  Such license shall be
[* * *], except that in the case BeiGene terminates this Agreement pursuant to
Section 15.2(c), then such license in the Territory shall be [* * *], provided
that [* * *].  Except as otherwise provided in this Section 15.3, all other
rights and licenses granted by BeiGene to AssemblyBio pursuant to this Agreement
shall terminate.

-72-

--------------------------------------------------------------------------------

(c)Sublicenses.  If the License granted to BeiGene terminates as a result of a
termination of this Agreement, the terms of this Section 15.3(c) will apply with
respect to any sublicense agreement existing as of the effective date of such
termination, but only if the applicable sublicensee did not contribute to any
material breach of this Agreement that was the cause of the termination by
AssemblyBio of this Agreement and is not otherwise in material breach of the
applicable sublicense agreement at such time. At the request of a sublicensee in
good standing, AssemblyBio will consider in good faith maintaining such
sublicense, provided that (i) all of such sublicensee’s obligations under the
applicable sublicense agreement to BeiGene will remain in effect as obligations
to AssemblyBio and will be enforceable solely by AssemblyBio as a third party
beneficiary; (ii) such sublicensee’s rights under the sublicense agreement that
do not exceed and are consistent with AssemblyBio’s obligations to BeiGene under
this Agreement, whether in scope, duration, nature or otherwise, will survive
termination; provided, that, the foregoing will in no way be interpreted to
increase the scope, duration, territory or other aspect of the rights
sublicensed to such sublicensee; and (iii) all of BeiGene’s rights under such
sublicense agreement will remain in effect, may be exercised solely by
AssemblyBio and will inure to the exclusive benefit of AssemblyBio.

(d)Regulatory Submissions. Upon AssemblyBio’s written request to the extent
delivered on or before the effective date of termination or within [* * *]
thereafter, BeiGene shall provide AssemblyBio with copies of all Regulatory
Submissions for Licensed Products. To the extent permissible under Applicable
Law, BeiGene shall assign to AssemblyBio or shall provide AssemblyBio with a
right of reference with respect to such Regulatory Submissions, as AssemblyBio
determines at its reasonable discretion, at BeiGene’s cost and expense. The
right of reference granted to AssemblyBio under Section 6.3 shall survive during
any transition period after the termination of this Agreement before all
relevant Regulatory Submissions, Regulatory Approvals and Pricing and
Reimbursement Approvals are transferred to AssemblyBio or a separate right of
reference is granted pursuant to this Section 15.3(d). In addition, upon
AssemblyBio’s written request, BeiGene shall, at its cost and expense, provide
to AssemblyBio copies of all material related documentation, including material
Clinical Data that are held by or reasonably available to BeiGene, its
Affiliates or sublicensees. The Parties shall discuss and establish appropriate
arrangements with respect to safety data exchange, provided that AssemblyBio
will assume all safety and safety database activities no later than [* * *]
after termination.

(e)Trademarks. BeiGene shall transfer and assign, and shall ensure that its
Affiliates transfer and assign, to AssemblyBio, at no cost to AssemblyBio, all
Product Marks relating to any Licensed Product and any applications therefor
(excluding any such marks that include, in whole or part, any corporate name or
logos of BeiGene or its Affiliates or sublicensees). AssemblyBio and its
Affiliates and licensees shall have the right to use other identifiers specific
to any Licensed Product (e.g., BeiGene compound identifiers). BeiGene shall also
transfer to AssemblyBio any in-process applications for generic names for any
Licensed Product.

(f)Inventory. At AssemblyBio’s election and request, BeiGene shall transfer to
AssemblyBio or its designee some or all inventory of Licensed Products
(including all final product, bulk drug substance, intermediates,
works-in-process, formulation materials, reference standards, drug product
clinical reserve samples, packaged retention samples, and the like) then in the
possession or control of BeiGene, its Affiliates or sublicensees; provided that,
AssemblyBio will pay BeiGene a price equal to [* * *] for such transferred
Licensed Products.

-73-

--------------------------------------------------------------------------------

(g)Wind Down and Transition. BeiGene shall be responsible, at its own cost and
expense, for the wind-down of BeiGene’s and its Affiliates’ and, subject to
Section 15.3(c), its sublicensees’ Development, Manufacture and
Commercialization activities for Licensed Products. BeiGene shall, and shall
cause its Affiliates and, subject to Section 15.3(c), its sublicensees to,
reasonably cooperate with AssemblyBio to facilitate orderly transition of the
Development, Manufacture and Commercialization of Licensed Products to
AssemblyBio or its designee, including (i) assigning or amending as appropriate,
upon request of AssemblyBio, any agreements or arrangements with Third Party
vendors (including distributors) to Develop, Manufacture, promote, distribute,
sell or otherwise Commercialize Licensed Products or, to the extent any such
Third Party agreement or arrangement is not assignable to AssemblyBio,
reasonably cooperating with AssemblyBio to arrange to continue to provide such
services for a reasonable time after termination; and (ii) to the extent that
BeiGene or its Affiliate is performing any activities described above in (i),
reasonably cooperating with AssemblyBio to transfer such activities to
AssemblyBio or its designee and continuing to perform such activities on
AssemblyBio’s behalf for a reasonable time after termination until such transfer
is completed.

(h)Ongoing Clinical Trial. If, at the time of such termination, BeiGene or its
Affiliates are conducting any Clinical Trials, then, at AssemblyBio’s election
on a Clinical Trial-by-Clinical Trial basis to the extent delivered on or before
the effective date of termination or within the [* * *] period immediately
thereafter: (i) to the extent permissible under Applicable Law, BeiGene shall,
and shall cause its Affiliates to, cooperate with AssemblyBio to transfer the
conduct of such Clinical Trial to AssemblyBio or its designees and complete such
transfer promptly and, in any case, within [* * *] after the termination
effective date, and AssemblyBio shall assume any and all liability for the
conduct of such transferred Clinical Trial after the effective date of such
transfer (except to the extent arising prior to the transfer date or from any
willful misconduct or negligent act or omission by BeiGene, its Affiliates or
their respective employees, agents and contractors or their violation of
Applicable Laws); and (ii) BeiGene shall, at its cost and expense, orderly
wind-down the conduct of any such Clinical Trial that is not assumed by
AssemblyBio under clause (i) above.

(i)Return of Confidential Information. At the Disclosing Party’s election, the
Receiving Party will return (at Disclosing Party’s expense) or destroy all
tangible materials comprising, bearing, or containing any Confidential
Information of the Disclosing Party relating to any Licensed Product that are in
the Receiving Party’s or its Affiliates’ possession or control and provide
written certification of such destruction (except to the extent any information
is the Confidential Information of both Parties or to the extent that the
Receiving Party has the continuing right to use the Confidential Information
under this Agreement); provided, that, the Receiving Party may retain one copy
of such Confidential Information for its legal archives.  Notwithstanding
anything to the contrary set forth in this Agreement, the Receiving Party will
not be required to destroy electronic files containing such Confidential
Information that are made in the ordinary course of its business information
back-up procedures pursuant to its electronic record retention and destruction
practices that apply to its own general electronic files and information, which
will continue to be subject to the applicable confidentiality and non-use
obligation under this Agreement.

(j)Costs of Termination Activities.  Notwithstanding anything to the contrary in
this Section 15.3, if BeiGene terminates this Agreement pursuant to Section
15.2(c), AssemblyBio will be responsible for the reasonable out-of-pocket costs
incurred by BeiGene

-74-

--------------------------------------------------------------------------------

directly in connection with the performance of the activities set forth in this
Section 15.3. BeiGene will invoice AssemblyBio quarterly for the foregoing costs
incurred by or on behalf of BeiGene, and AssemblyBio will pay the invoiced
amounts within [* * *] after the date of any such invoice. If this Agreement is
terminated for other reasons, BeiGene shall be responsible for the costs
incurred in connection with the performance of such activities to the extent not
otherwise set forth in this Section 15.3.

15.4Continuation of Agreement in Lieu of Termination by BeiGene for Breach.
Notwithstanding anything to the contrary in this Article 15, if BeiGene has the
right to terminate this Agreement pursuant to Section 15.2(c), then, at
BeiGene’s option (which may be exercised by BeiGene by written notice to
AssemblyBio within [* * *] of the date of delivery by BeiGene of the notice of
termination), BeiGene may elect not to terminate this Agreement, in which case
the rights and obligations of the Parties under this Agreement shall continue
following the effective date of termination, including the License granted by
AssemblyBio to BeiGene pursuant to Section 2.1 and the right of AssemblyBio to
receive the milestone and royalty payments pursuant to Article 9; provided that
AssemblyBio’s rights and BeiGene’s obligations under Sections 3.2, 3.3, 5.8,
8.2, 8.3 and 8.4(b) shall terminate (with respect to Sections 3.2, 3.3 and 5.8,
only in relation to activities in the Territory, which sections shall remain
effective for any global Development activities).

15.5Survival. Expiration or termination of this Agreement shall not relieve the
Parties of any obligation accruing prior to such expiration or termination.
Without limiting the foregoing, the provisions of Article 1 (as applicable),
Article 10, Article 11, Article 13 and Article 16 (as applicable), and Sections
2.4 (subject to Section 15.3(b)), 2.5, 2.8 (only to the extent any terms and
conditions of the Upstream License set forth in Exhibit 2.8 survive the
termination or expiration thereof or of any sublicense agreements by their
express terms or by reasonable implication), 5.6, 5.9 (with respect to
AssemblyBio’s use rights), 5.10 (with respect to responsibility for
subcontractors), 9.5, 9.8 through 9.10 (with respect to Sections 9.5, and 9.8
through 9.10, solely in connection with amounts accrued prior to termination or
expiration of this Agreement but not paid as of the termination or expiration of
this Agreement), 12.6, 13.5, 14.1, 14.2(c), 15.1, 15.3, 15.5, and 15.6 shall
survive the expiration or termination of this Agreement for any reason.

15.6Termination Not Sole Remedy. Termination is not the sole remedy under this
Agreement and, whether or not termination is effected and notwithstanding
anything contained in this Agreement to the contrary, all other remedies shall
remain available except as agreed to otherwise herein.

Article 16

MISCELLANEOUS

16.1Standstill. BeiGene agrees that for a period of two years from and after the
Effective Date (the “Standstill Period”), unless specifically invited by
AssemblyBio, neither BeiGene, any of Affiliates, nor its and their
representatives acting on behalf of BeiGene or its Affiliates shall (and BeiGene
shall cause its Affiliates and its and their representatives not to), directly
or indirectly:

(a)  elect, propose or consummate, or announce an intention to effect or
knowingly facilitate or encourage any other person to elect, propose or
consummate: (i) the

-75-

--------------------------------------------------------------------------------

acquisition of record or beneficial ownership of any voting securities of
AssemblyBio or any rights to acquire such voting securities; (ii) any merger,
consolidation, or business combination with AssemblyBio; (iii) any
recapitalization, restructuring, liquidation, dissolution or other similar
extraordinary transactions with respect to AssemblyBio; or (iv) any
“solicitation” of “proxies” (as such terms are used in Regulation 14A of the
Exchange Act) or consents to vote (whether or not related to the election or
removal of directors) with respect to any voting securities of AssemblyBio, or
the initiation, proposal, encouragement or solicitation of stockholders of
AssemblyBio for the approval of any stockholder proposals with respect to
AssemblyBio, or the solicitation, advisement or influence of any person with
respect to the voting of any voting securities of AssemblyBio;

(b)form, join or in any way participate in a “group” as defined in Section
13(d)(3) or Section 14(d)(2) of the Exchange Act with respect to any voting
securities of AssemblyBio or otherwise in connection with any of the foregoing;

(c)(i) call or seek to call any meeting of stockholders of AssemblyBio,
including by written consent, or provide to any Third Party a proxy, consent or
requisition to call any meeting of stockholders of AssemblyBio; (ii) seek
representation on the Board of Directors of AssemblyBio; or (iii) seek the
removal of any member of the Board of Directors or management of AssemblyBio; or

(d)publicly disclose any intention, plan or arrangement, whether written or
oral, inconsistent with the foregoing;

provided, however, that (i) notwithstanding the foregoing, BeiGene shall not be
restricted from [* * *] and (ii) BeiGene will cease to be bound by the
provisions of clauses (a) through (d) above upon (A) the public announcement or
entry by AssemblyBio into a definitive agreement with a Third Party for a
transaction involving the acquisition of more than [* * *] of the outstanding
equity securities of AssemblyBio or all or a substantial portion of the assets
of AssemblyBio by way of merger, consolidation, business combination, tender or
exchange offer, recapitalization, restructuring, sale, equity issuance or
otherwise or (B) the public announcement by AssemblyBio that it has undertaken a
process for the sale of more than [* * *] of the outstanding equity securities
of AssemblyBio or all or a substantial portion of the assets of AssemblyBio by
way of merger, consolidation, business combination, tender or exchange offer,
recapitalization, restructuring, sale, equity issuance or otherwise.

16.2Assignment. Except as provided in this Section 16.2, this Agreement may not
be assigned or otherwise transferred, nor may any right or obligation hereunder
be assigned or transferred, by either Party without the consent of the other
Party; provided, however, that (and notwithstanding anything elsewhere in this
Agreement to the contrary) either Party may, without the written consent of the
other Party, assign this Agreement and its rights and obligations hereunder in
whole or in part to an Affiliate of such Party (for so long as such entity
remains an Affiliate of such Party) and (a) BeiGene may, without the written
consent of AssemblyBio, assign this Agreement and its rights and obligations
hereunder (or under a transaction under which this Agreement is assumed) in
connection with the transfer or sale of all or substantially all of its assets
or business, or in the event of its merger or consolidation or similar
transaction; and (b) AssemblyBio may, without the written consent of BeiGene,
assign this Agreement and its rights and obligations hereunder (or under a
transaction under which this Agreement is assumed) in

-76-

--------------------------------------------------------------------------------

connection with the transfer or sale of all or substantially all of its assets
or business, or in the event of its merger or consolidation or similar
transaction.  Any attempted assignment not in accordance with this Section 16.2
shall be void.  Any permitted assignee shall expressly assume all assigned
obligations of its assignor under this Agreement in writing. Section 14.2 of
Exhibit 2.8 shall apply to any encumbrance, pledge or hypothecation of either
Party’s rights granted in this Agreement.

16.3Extension to Affiliates. Except as expressly set forth otherwise in this
Agreement, each Party shall have the right to extend the rights and obligations
granted in this Agreement to one or more of its Affiliates by providing written
notice to the other Party.  All applicable terms and provisions of this
Agreement, except this right to extend, shall apply to any such Affiliate to
which this Agreement has been extended to the same extent as such terms and
provisions apply to the Party extending such rights and obligations.  The Party
extending the rights and obligations granted hereunder shall remain primarily
liable for any acts or omissions of its Affiliates.

16.4Severability. Should one or more of the provisions of this Agreement become
void or unenforceable as a matter of Applicable Laws, then this Agreement shall
be construed as if such provision were not contained herein and the remainder of
this Agreement shall be in full force and effect, and the Parties will use their
best efforts to substitute for the invalid or unenforceable provision a valid
and enforceable provision which conforms as nearly as possible with the original
intent of the Parties.

16.5Governing Law; English Language. This Agreement shall be governed by and
construed in accordance with the laws of the State of New York and the patent
laws of the United States without reference to any rules of conflict of
laws.  This Agreement was prepared in the English language, which language shall
govern the interpretation of, and any dispute regarding, the terms of this
Agreement.

16.6Dispute Resolution.

(a)If any dispute, claim or controversy of any nature arising out of or relating
to this Agreement, including any action or claim based on tort, contract or
statute, or concerning the interpretation, effect, termination, validity,
performance or breach of this Agreement (each, a “Dispute”), arises between the
Parties and the Parties cannot resolve such Dispute through good faith
discussions, within [* * *] of a written request by either Party to the other
Party (“Notice of Dispute”), either Party may refer the Dispute to Executive
Officers of each Party for resolution.  Each Party, within [* * *] after a Party
has received such written request from the other Party to so refer such Dispute,
shall notify the other Party in writing of the specific Executive Officer to
whom such dispute is referred.  If, after an additional [* * *] after the Notice
of Dispute, such Executive Officers have not succeeded in negotiating a
resolution of the Dispute, and a Party wishes to pursue the matter, each such
Dispute, controversy or claim that is not an “Excluded Claim” (defined below)
shall be finally resolved by binding arbitration administered by JAMS (“JAMS”)
(or any successor entity thereto) pursuant to its arbitration rules and
procedures then in effect (the “Rules”), as modified in this Section 16.6.  

(b)The arbitration shall be conducted by a tribunal of arbitrators experienced
in the business of pharmaceuticals. The tribunal shall be compromised of three
(3) arbitrators, one of whom shall be nominated by each Party and a third of
whom, who shall serve as the presiding

-77-

--------------------------------------------------------------------------------

arbitrator, shall be nominated by mutual agreement of the two party-nominated
arbitrators.  If the two party-nominated arbitrators do not nominate the third
arbitrator within [* * *] of the second arbitrator’s appointment, then the third
arbitrator shall be appointed by JAMS. If the issues in dispute involve
scientific, technical or commercial matters, the arbitrators chosen hereunder
shall engage experts that have educational training or industry experience
sufficient to demonstrate a reasonable level of relevant scientific, medical and
industry knowledge, as necessary to resolve the dispute. Within [* * *] after
initiation of arbitration, the Parties shall select the arbitrators.  The place
of arbitration shall be New York City, New York, and all proceedings and
communications shall be in English.

(c)Prior to the arbitrators being selected, either Party, without waiving any
remedy under this Agreement, may seek from any court having jurisdiction any
temporary injunctive or provisional relief necessary to protect the rights or
property of that Party until final resolution of the issue by the arbitrator or
other resolution of the controversy between the Parties.  Once the arbitrators
have been selected, either Party may apply to the arbitrators for interim
injunctive relief until the arbitration award is rendered or the controversy is
otherwise resolved, and either Party may apply to a court of competent
jurisdiction to enforce interim injunctive relief granted by the
arbitrators.  Any final award by the arbitrators may be entered by either Party
in any court having appropriate jurisdiction for a judicial recognition of the
decision and applicable orders of enforcement.  The arbitrators shall have no
authority to award punitive or any other type of damages not measured by a
Party’s compensatory damages.  Each Party shall bear its own costs and expenses
and attorneys’ fees and an equal share of the arbitrators’ fees and any
administrative fees of arbitration, unless the arbitrators agree otherwise.

(d)Except extent necessary to confirm an award or as may be required by law,
neither a Party nor the arbitrators may disclose the existence, content, or
results of an arbitration without the prior written consent of both Parties.  In
no event shall an arbitration be initiated after the date when commencement of a
legal or equitable proceeding based on the dispute, controversy or claim would
be barred by the applicable New York statute of limitations.

(e)As used in this Section 16.6, the term “Excluded Claim” means any dispute,
controversy or claim that concerns (i) the validity, enforceability or
infringement of any patent, trademark or copyright, or (ii) any antitrust,
anti-monopoly or competition law or regulation, whether or not statutory.  Any
Excluded Claim may be submitted by either Party to any court of competent
jurisdiction over such Excluded Claim.

16.7Resolution of Certain Disputes.

(a)Application to Certain Disputes.  The provisions of this Section 16.7 shall
apply with respect to any dispute that has not been resolved within the [* * *]
period following referral to Executive Officers described in Section 16.6(a),
where such dispute concerns (i) [* * *], (ii) [* * *], and (iii) other matters
that the Parties mutually agree should be subject to the dispute resolution
mechanism set forth under this Section 16.7 (an “Expert Dispute”).

(b)Resolution by Expert.  If the Parties do not reach a mutually acceptable
resolution as to an Expert Dispute within the [* * *] period following referral
to Executive Officers described in Section 16.6(a), then upon written notice by
either Party (an “Expert Resolution

-78-

--------------------------------------------------------------------------------

Notice”), the Expert Dispute shall be resolved by a final, binding determination
by an independent expert in the manner described in this Section 16.7.

(c)Selection of Expert and Submission of Positions.  The Parties shall select
and agree upon a mutually acceptable independent Third Party expert who is
neutral, disinterested and impartial, and has at least [* * *] of commercial
pharmaceutical industry experience (the “Expert”).  If the Parties are unable to
mutually agree upon an Expert within [* * *] following the delivery of the
Expert Resolution Notice, then upon request by either Party, then the Expert
shall be an arbitrator appointed by JAMS, which arbitrator need not have the
above-described experience.  Once the Expert has been selected, each Party shall
within [* * *] following selection of the Expert provide the Expert and the
other Party with a written report setting forth its position with respect to the
substance of the Expert Dispute and may submit a revised or updated report and
position to the Expert within [* * *] of receiving the other Party’s report.  If
so requested by the Expert, each Party shall make oral submissions to the Expert
based on such Party’s written report delivered pursuant to this Section 16.7(c),
and each Party shall have the right to be present during any such oral
submissions.

(d)JAMS Supervision.  In the event the Expert is a JAMS arbitrator selected by
JAMS as provided in Section 16.7(c) above, the matter shall be conducted as a
binding arbitration in accordance with JAMS procedures, as modified by this
Section 16.7 (including that the arbitrator shall adopt as his or her decision
the position of one Party or the other, as described in Section 16.7(c)).  The
arbitrator shall retain a neutral, disinterested and impartial Third Party
expert with experience relevant to the specific subject matter of the particular
Expert Dispute to assist in rendering such decision, and the expenses of such
expert shall be shared by the Parties as costs of the arbitration.

(e)Determination by the Expert.  The Expert shall, no later than [* * *] after
the last submission of the written reports and, if any, oral submissions, select
one of the Party’s positions as his or her final decision, and shall not have
the authority to modify either Party’s position or render any substantive
decision other than to so select the position of either BeiGene or AssemblyBio
as set forth in their respective written report (as initially submitted, or as
revised in accordance with Section 16.7(c), as applicable).  The Parties agree
that the decision of the Expert shall be the sole, exclusive and binding remedy
between them regarding any Expert Dispute presented to the Expert, and the
Expert’s decision shall become the decision of the JSC on the matter.

(f)Location; Costs.  Unless otherwise mutually agreed upon by the Parties, the
location and costs of any dispute resolution under this Section 16.7 shall be as
set forth in Section 16.6.

(g)Timetable for Completion.  The Parties shall use, and shall direct the Expert
to use, best efforts to resolve any Expert Dispute within [* * *] after the
selection of the Expert, or if resolution within [* * *] is not reasonably
achievable, as determined by the Expert, then as soon thereafter as is
reasonably practicable.

16.8Force Majeure. Neither Party shall be responsible to the other for any
failure or delay in performing any of its obligations under this Agreement or
for other nonperformance hereunder (excluding, in each case, the obligation to
make payments when due) if such delay or

-79-

--------------------------------------------------------------------------------

nonperformance is caused by strike, fire, flood, earthquake, accident, war, act
of terrorism, act of God or of the government of any country or of any local
government, or by any other cause unavoidable or beyond the control of any Party
hereto.  In such event, the Party affected will use reasonable efforts to resume
performance of its obligations and will keep the other Party informed of actions
related thereto.  If any such failure or delay in a Party’s performance
hereunder continues for more than [* * *], the other Party may terminate this
Agreement upon written notice to he delayed Party.

16.9Waivers and Amendments. The failure of any Party to assert a right hereunder
or to insist upon compliance with any term or condition of this Agreement shall
not constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other Party.  No waiver shall be
effective unless it has been given in writing and signed by the Party giving
such waiver.  No provision of this Agreement may be amended or modified other
than by a written document signed by authorized representatives of each Party.

16.10Relationship of the Parties.  Nothing contained in this Agreement shall be
deemed to constitute a partnership, joint venture, or legal entity of any type
between AssemblyBio and BeiGene, or to constitute one as the agent of the
other.  Each Party shall act solely as an independent contractor, and nothing in
this Agreement shall be construed to give any Party the power or authority to
act for, bind, or commit the other.

-80-

--------------------------------------------------------------------------------

16.11Notices.  All notices, consents or waivers under this Agreement shall be in
writing and will be deemed to have been duly given when (a) scanned and
converted into a portable document format file (i.e., pdf file), and sent as an
attachment to an e-mail message, where, when such message is received, a read
receipt e-mail is received by the sender (and such read receipt e-mail is
preserved by the Party sending the notice), provided that a copy is promptly
sent by an internationally recognized overnight delivery service (receipt
requested) (although the sending of the e-mail message shall be when the notice
is deemed to have been given), or (b) the earlier of when received by the
addressee or [* * *] after it was sent, if sent by registered letter or
overnight courier by an internationally recognized overnight delivery service
(receipt requested), in each case to the appropriate addresses and e-mail
addresses set forth below (or to such other addresses and e-mail addresses as a
Party may designate by notice):

If to AssemblyBio:

 

Assembly Biosciences, Inc.

331 Oyster Point Blvd., 4th Floor

South San Francisco, CA 94080

Attention:  Chief Legal and Business Officer

E-mail address:  [* * *]

 

with copies to:

 

Ropes & Gray LLP

36F Park Place

1601 Nanjing Road West

Shanghai, China 200040

Attention: [* * *]

Email address: [* * *]

If to BeiGene:

BeiGene, Ltd.

c/o Mourant Governance Services (Cayman) Limited

94 Solaris Avenue

Camana Bay

PO Box 1348

Grand Cayman, KY1-1108,

Cayman Islands

Attention: Chief Financial and Strategy Officer

E-mail address:  [* * *]

 

With copies to:

 

BeiGene, Ltd.

55 Cambridge Parkway, Suite 700W

Cambridge, MA 02142

Attn:  Senior Vice President, General Counsel

E-mail address:  [* * *]

-81-

--------------------------------------------------------------------------------

 

16.12Further Assurances.  BeiGene and AssemblyBio hereby covenant and agree
without the necessity of any further consideration, to execute, acknowledge and
deliver any and all documents and take any action as may be reasonably necessary
to carry out the intent and purposes of this Agreement.

16.13Compliance with Law.  Each Party shall perform its obligations under this
Agreement in accordance with all Applicable Laws.  No Party shall, or shall be
required to, undertake any activity under or in connection with this Agreement
which violates, or which it believes, in good faith, may violate, any Applicable
Laws.

16.14No Third Party Beneficiary Rights.  This Agreement is not intended to and
shall not be construed to give any Third Party any interest or rights (including
any Third Party beneficiary rights) with respect to or in connection with any
agreement or provision contained herein or contemplated hereby, except as
otherwise expressly provided for in this Agreement.

16.15Entire Agreement.  This Agreement sets forth the entire agreement and
understanding of the Parties as to the subject matter hereof and supersedes all
proposals, oral or written, and all other communications between the Parties
with respect to such subject matter. The Parties acknowledge and agree that, as
of the Effective Date, all Confidential Information disclosed pursuant to the
Confidentiality Agreement by a Party or its Affiliates shall be included in the
Confidential Information subject to this Agreement and the Confidentiality
Agreement is hereby superseded in its entirety; provided, that the foregoing
shall not relieve any Person of any right or obligation accruing under the
Confidentiality Agreement prior to the Effective Date.  “Confidentiality
Agreement” means the Non-Disclosure Agreement between AssemblyBio and BeiGene
dated [* * *].

16.16Counterparts.  This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

16.17Expenses.  Each Party shall pay its own costs, charges and expenses
incurred in connection with the negotiation, preparation and completion of this
Agreement.

16.18Binding Effect.  This Agreement shall be binding upon and inure to the
benefit of the Parties and their respective successors and permitted assigns.

16.19Construction.  The Parties hereto acknowledge and agree that: (a) each
Party and its counsel reviewed and negotiated the terms and provisions of this
Agreement and have contributed to its revision; (b) the rule of construction to
the effect that any ambiguities are resolved against the drafting Party shall
not be employed in the interpretation of this Agreement; and (c) the terms and
provisions of this Agreement shall be construed fairly as to all Parties hereto
and not in a favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement.

16.20Cumulative Remedies.  No remedy referred to in this Agreement is intended
to be exclusive unless explicitly stated to be so, but each shall be cumulative
and in addition to any other remedy referred to in this Agreement or otherwise
available under law.

-82-

--------------------------------------------------------------------------------

16.21Export.  Each Party acknowledges that the laws and regulations of the
United States restrict the export and re-export of commodities and technical
data of United States origin.  Each Party agrees that it will not export or
re-export restricted commodities or the technical data of the other Party in any
form without appropriate United States and foreign government licenses.

16.22Notification and Approval.  In the event that this Agreement or the
transaction(s) set forth herein are subject to notification or regulatory
approval in one or more countries, then development and commercialization in
such country(ies) will be subject to such notification or regulatory
approval.  The Parties will reasonably cooperate with each other with respect to
such notification and the process required thereunder, including in the
preparation of any filing.  BeiGene will be responsible for any and all costs,
expenses, and filing fees associated with any such filing.

[Remainder of page left blank intentionally.]

 

 

-83-

--------------------------------------------------------------------------------

 

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement
to be executed by their duly authorized representatives.

 

ASSEMBLY BIOSCIENCES, INC.

 

 

 

 

 

 

By:

 

/s/ Jason A. Okazaki

Name:

 

Jason A. Okazaki

Title:

 

Chief Legal and Business Officer

 

[Signature Page to Collaboration Agreement]

--------------------------------------------------------------------------------

 

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement
to be executed by their duly authorized representatives.

 

BEIGENE, LTD.

 

 

 

 

 

 

By:

 

/s/ Guillaume Vignon, Ph.D.

Name:

 

Guillaume Vignon, Ph.D.

Title:

 

Senior Vice President, Business Development

 

 

 

[Signature Page to Collaboration Agreement]

--------------------------------------------------------------------------------

 

List of Exhibits

 

Exhibit 1.56

 

Structure of Listed Compounds

Exhibit 2.1

 

Upstream License Provisions Related to License Grant

Exhibit 2.8

 

Applicable Upstream License Provisions

Exhibit 5.2(c)

 

ABI-H0731 Initial Development Plan

Exhibit 5.4(e)

 

Cost Sharing Examples

Exhibit 5.5(c)

 

AssemblyBio Ancillary Trials and Budget

Exhibit 11.4

 

Joint Press Release

Exhibit 12.2(a)

 

Scheduled Patent Rights

Exhibit 12.2(m)

 

Assignment Related to Scheduled Patent Rights

Exhibit 14.6

 

Upstream License Provisions Related to IP Prosecution and Enforcement

 

 

 

 

--------------------------------------------------------------------------------

 

EXHIBIT 2.1

UPSTREAM LICENSE PROVISIONS RELATED TO LICENSE GRANT

 

2

Definitions: For the purposes of this Exhibit 2.1 and the Agreement, the
following words and phrases have the meanings assigned to them below. Please
refer to Exhibit 2.8 for the definition of other capitalized terms.

“Agreement” referenced in this Exhibit 2.1 refers to the Upstream License.

2.3

Field: Diagnostics and therapeutics.

2.5

Licensed Product: Any product: (i) the making, using or selling of which, absent
the license granted hereunder, would infringe one or more pending or issued
Valid Claims (without giving effect to any safe harbor from infringement under
35 U.S.C. 271 (e)(1)); or (ii) that is made by, uses, or is used by a process
that, absent the license granted hereunder, would infringe one or more pending
or issued Valid Claims.

2.8

Patent Rights:

 

2.8.1

The patent applications (including provisionals) filed or to be filed as listed
on Exhibit A;

 

2.8.2

All U.S. patent applications directly or indirectly claiming priority to the
abovereferenced patents or applications, including divisionals, continuations,
and claims in continuations-in-part applications that are entitled to the
priority filing date of any of the above;

 

2.8.3

Foreign equivalent applications;

 

2.8.4

Patents issuing from the above applications;

 

2.8.5

Reissues, re-examinations and extensions of the above, supplementary protection
certificates and any patents issuing therefrom; and

 

2.8.6

Any of the foregoing during reissue, re-examination, or post grant review
proceedings.

2.10

Sublicensee: A non-Affiliate third party to whom Assembly has granted a
Sublicense pursuant to and in accordance with Article 3 of this Agreement.
“Sublicense” is an arms- length agreement in which Assembly:

 

2.10.1

Grants or sublicenses any of the rights granted hereunder;

 

2.10.2

Agrees not to assert the Patent Rights or agrees not to sue, prevent, or seek a
legal remedy for the practice of same; or

 

2.10.3

Has agreed to do any of the foregoing, including but not limited to licenses,
option agreements, right of first refusal agreements, standstill agreements,

Exhibit 2.1-1

--------------------------------------------------------------------------------

 

 

settlement agreements, co-development agreements, co-promotion agreements, joint
venture agreements, or other agreements.

2.12

Term: Commencing on the Effective Date and continuing until the expiration of
the last to expire of the patents in the Patent Rights unless earlier terminated
in accordance with this Agreement.

2.13

Territory: Anywhere in the world, except those countries to which export of
technology or goods is prohibited by applicable United States export control
laws or regulations.

2.14

Valid Claim: A claim of a pending Patent Rights patent application or of an
issued and unexpired Patent Rights patent, in each case that has not lapsed or
been held revoked, invalid or unenforceable by a court or other governmental
agency of competent jurisdiction in a decision or order that is not subject to
appeal, provided that if a pending patent application has not issued within five
(5) years from receiving a first US office action or foreign equivalent, the
claims of such patent application will no longer be considered Valid Claims
hereunder.

3

Grant: Subject to the terms and conditions of this Agreement and in
consideration of Assembly’s satisfaction of its obligations hereunder, IURTC
hereby grants to Assembly and Assembly hereby accepts, the following license
during the Term in the Territory:

3.1

An exclusive license to IURTC’s and the Institutions’ ownership rights in the
Patent Rights, to make, have made, use, offer for sale, sell, and import
Licensed Products in the Field.

3.2

The rights licensed to Assembly hereunder, except for the right to grant
Sublicenses, may be extended to Affiliates provided that each such Affiliate
first agrees in a written agreement to be bound by the terms and conditions of
this Agreement as Assembly is bound, and such agreement: (a) names IURTC as a
third party beneficiary; (b) terminates upon termination of this Agreement; and
(c) is not transferable. Any Affiliate that desires to exercise any of the
rights granted hereunder will enter into such written agreement with Assembly
prior to exercising such rights. Assembly will deliver to IURTC a copy of said
agreement and any amendment thereto within thirty (30) days of each execution.
Assembly agrees to be fully responsible for the performance of such Affiliates
and liable for their compliance herewith.

3.3

Assembly may grant Sublicenses to non-Affiliate third parties under this
Agreement. Only Assembly, and not its Affiliates, is permitted to grant
Sublicenses. Notwithstanding the foregoing, Sublicensees may grant
sub-sublicenses (through multiple tiers) under the Agreement solely: (i) to
their Affiliates, provided that any such sub-sublicenses shall automatically
terminate if the sub-sublicensee party thereto ceases to be an Affiliate of the
Sublicensee; (ii) subject to the terms of the Sublicense, to contract research
organizations, distributors and other third party subcontractors for the sole
purpose of performing

Exhibit 2.1-2

--------------------------------------------------------------------------------

 

Sublicensee’s obligations under the Sublicense; and (iii) to any other third
party subject to IURTC’s prior written consent, not to be unreasonably withheld,
conditioned or delayed.

 

3.3.1

Any Sublicense granted by Assembly under this Agreement will be consistent with
the terms and conditions of this Agreement and will:

 

3.3.1.1

Contain the terms and conditions set forth in definition 2.6 and the definitions
it references, and in paragraphs 3.4, 3.6, 3.7, 6.3, 8.5, 8.6, 9.7, 16.6, and
16.8, and in Article 7 modified only to indicate that Sublicensee is under the
same obligations as Assembly;

 

3.3.1.2

Contain the terms and conditions set forth in paragraph 6.2 and the definitions
it references modified only to indicate that the Sublicensee is obligated to
Assembly as Assembly is to IURTC; and

 

3.3.1.3

Contain the terms and conditions set forth in Articles 11, 12, and paragraph
7.5, modified only to indicate that the Sublicensee is obligated to IURTC and IU
as Assembly is obligated to IURTC and IU hereunder.

 

3.3.2

If Assembly voluntarily enters bankruptcy or receivership, or if an involuntary
bankruptcy action is filed against Assembly and not dismissed within ninety (90)
days, then upon notice from IURTC, royalties based on Sublicensee’s Net Sales
and Sublicensing Revenue then or thereafter due to Assembly will become directly
due and owing to IURTC for the account of Assembly. IURTC will remit to Assembly
any amounts received that exceed the sum actually owed by Assembly to IURTC.

 

3.3.3

Within thirty (30) days of the effective date of any Sublicense, Assembly will
provide IURTC a complete copy of the Sublicense and all exhibits thereto, along
with Assembly’s representation and warranty that no prior, contemporaneous,
planned, or proposed contractual relationships between Assembly and Sublicensee
contain consideration to Assembly reasonably attributable to the sublicensed
rights. If the original Sublicense is written in a language other than English,
the copy of the Sublicense and all exhibits thereto will be accompanied by a
complete translation written in English. Assembly represents and warrants that
such translation will be a true and accurate translation of the Sublicense and
its exhibits.

 

3.3.4

Assembly agrees to be fully responsible for the performance of its Sublicensees
hereunder and any sub-sublicensees under any sub-sublicenses granted by
Sublicensee. Any act or omission by a Sublicensee or sub-sublicensee that would
be a breach of this Agreement if imputed to Assembly will be deemed to be a
breach by Assembly of this Agreement.

3.4

IURTC and the Institutions retain the right to practice under the Patent Rights
for noncommercial educational and research purposes and permit other
universities and nonprofit research institutes to do the same for non-commercial
educational and research purposes.

Exhibit 2.1-3

--------------------------------------------------------------------------------

 

Assembly may not in any way restrict the rights of IU, other universities or
non-profit research institutions, or their faculty, staff, students, or
employees from publishing the results of their research related to the Patent
Rights.

3.5

This Agreement provides Assembly and Sublicensees no ownership rights of any
kind in the Patent Rights, provided that the Parties acknowledge that Assembly
has joint ownership rights in certain Patent Rights as set forth on Exhibit A.
All ownership rights, other than such joint ownership rights owned by Assembly,
remain the property of the Institutions and/or IURTC.

3.6

In accordance with 35 U.S.C. §§ 200-212, 37 C.F.R. Part 401, and in the relevant
government research contracts with the Institutions, the United States
government retains certain rights to inventions arising from federally supported
research or development. Under these laws and implementing regulations, the
government may impose requirements on such inventions. To the extent applicable,
such rights and requirements include without limitation (i) the grant of a
nonexclusive, nontransferable, irrevocable, paid-up license to practice or have
practiced for or on behalf of the government any of the Patent Rights throughout
the world, and (ii) the requirement that Licensed Products used or sold in the
U.S. will be manufactured substantially in the U.S. The rights granted in this
Agreement are expressly made subject to these laws and regulations as they may
be amended from time to time. Assembly will be required to abide by all
applicable laws and regulations. IURTC agrees to cooperate with Assembly in
connection with attempting to secure any waiver of any obligations under 35
U.S.C. §204.

13.5

Upon termination of this Agreement, Assembly will promptly notify its
Sublicensees of such termination. Any rights previously granted by Assembly
under any Sublicense hereunder will be automatically revoked thirty (30) days
following the effective date of termination of this Agreement. However,
Sublicensees have the right to enter into a written license agreement with IURTC
before their Sublicense is revoked, through which such Sublicensee will become
bound to IURTC on substantially the same terms and conditions (including
financial terms) as it was bound to Assembly under the Sublicense, but only to
the extent that each financial term is no less favorable to IURTC than
those  set forth in Article 5 and paragraphs 9.3 and 9.4, and provided that the
Sublicense does not impose any obligations on IURTC in excess of those imposed
under this Agreement. If any Sublicensee desires to enter into such a license
agreement, it will be wholly the responsibility of that Sublicensee to notify
IURTC of such desire within thirty (30) days after the effective date of
termination of this Agreement. IURTC hereby agrees to enter into such written
license agreement, with modifications as is reasonably necessary to accommodate
the functional and structural differences between Assembly and IURTC. Failure of
a Sublicensee to timely enter into such a license agreement will automatically
result in the termination of the Sublicense and all rights granted thereunder.

 

 

Exhibit 2.1-4

--------------------------------------------------------------------------------

 

EXHIBIT 2.8

APPLICABLE UPSTREAM LICENSE PROVISIONS

All terms and conditions in this Exhibit 2.8 which shall be considered an
integral part of the terms and conditions of the Collaboration Agreement, and,
pursuant to Section 3.3.1 of the Agreement:

 

 

•

The terms and conditions set forth in definition 2.6 and the definitions it
references, and in paragraphs 3.4, 3.6, 3.7, 6.3, 8.5, 8.6, 9.7, 16.6, and 16.8,
and in Article 7 shall be considered modified only to indicate that BeiGene is
under the same obligations as AssemblyBio;

 

•

The terms and conditions set forth in paragraph 6.2 and the definitions it
references shall be considered modified only to indicate that the BeiGene is
obligated to AssemblyBio as AssemblyBio is to IURTC; and

 

•

The terms and conditions set forth in Articles 11, 12, and paragraph 7.5 shall
be considered modified only to indicate that the BeiGene is obligated to IURTC
and IU as AssemblyBio is obligated to IURTC and IU hereunder.

 

2

Definitions: For the purposes of this Exhibit 2.8 and the Agreement, the
following words and phrases have the meanings assigned to them below.

“Agreement” referenced in this Exhibit 2.8 refers to the Upstream License.

“Collaboration Agreement” referenced in this Exhibit 2.8 refers to the
Collaboration Agreement by and between Assembly Biosciences, Inc. and BeiGene,
Ltd. dated July 17, 2020.

“Effective Date” for the Agreement is September 3, 2013.

“Institutions” means collectively, The Scripps Research Institute and Indiana
University (“IU”).

2.1

Affiliate: Any person or entity that, directly or indirectly, owns or controls
Assembly or that is owned or controlled by or under common ownership or control
with Assembly. Own(s) or control(s) means:

 

2.1.1

Direct or indirect ownership of at least 50% of the outstanding voting
securities of a corporation;

 

2.1.2

The right to receive at least 50% of the earnings of the person, corporation, or
other entity in question; or

 

2.1.3

The right to control the business decisions of the person, corporation, or other
entity in question.

Exhibit 2.8-1

--------------------------------------------------------------------------------

 

2.2

Development Plan: Assembly’s good faith, bona fide plan for the development,
manufacture, promotion, importation, use, sale and/or marketing of Licensed
Products. The Development Plan will include, at a minimum:

 

 

2.2.1

A definition and/or specification of each Licensed Product planned for
development;

 

2.2.2

Tasks to be performed by Assembly, its contractors and/or Sublicensees to
develop each Licensed Product to the point of commercialization, including
estimated time schedules for specific tasks;

 

2.2.3

Tasks to be performed to achieve any regulatory approval or other certification
of each Licensed Product, including estimated time schedules for each; and

 

2.2.4

Identification of the primary country(ies) in which Assembly plans to sell each
Licensed Product and a good faith estimate of time of First Commercial Sale in
the primary country(ies).

2.3

Field: Diagnostics and therapeutics.

2.4

Licensed Product: Any product: (i) the making, using or selling of which, absent
the license granted hereunder, would infringe one or more pending or issued
Valid Claims (without giving effect to any safe harbor from infringement under
35 U.S.C. 271 (e)(1)); or (ii) that is made by, uses, or is used by a process
that, absent the license granted hereunder, would infringe one or more pending
or issued Valid Claims.

2.6

Net Sales: The fair market cash value of all value, compensation, and payments
received from the Sale of Licensed Products, less the following:

 

2.6.1

Trade, quantity, and cash rebates on Licensed Products actually provided to
third parties;

 

2.6.2

Credits, allowances, or refunds, not to exceed the original invoice amount, for
actual claims, damaged goods, rejections, or returns of Licensed Products; and

 

2.6.3

Excise, sale, use, value added, or other taxes, other than income taxes, that
are included in the amounts received and that are paid by Assembly or
Sublicensees for Licensed Products.

In the event that a Licensed Product is bundled or integrated with one or more
other products (such Licensed Product together with such other product(s), a
“Bundled Product”), Net Sales will be calculated on the basis of the total
invoice price of the Bundled Product multiplied by a fraction, the numerator of
which will be the list price of the Licensed Product and the denominator of
which will be an amount equal to the aggregate of all list prices of the
Licensed Product and all other products in the applicable Bundled Product. In
the event that there is Bundled Product and the list price of the Licensed
Product and each other product in the applicable Bundled Product cannot be
determined, then (a) the parties will negotiate in good faith to agree in
writing on the relative value of the

Exhibit 2.8-2

--------------------------------------------------------------------------------

 

Licensed Product and each other product in the applicable Bundled Product, which
determination will be based upon sales prices for comparable products or
processes, and (b) such relative value(s) will be used in calculating Net Sales.
The deductions set forth in clauses 2.6.1 through 2.6.3 will be applied to the
total invoice price for the applicable Bundled Product prior to calculating Net
Sales of the Licensed Product.

2.7

Party: Individually, IURTC or Assembly. Collectively, IURTC and Assembly may be
referred to as the “Parties.”

2.8

Patent Rights:

 

2.8.1

The patent applications (including provisionals) filed or to be filed as listed
on Exhibit A;

 

2.8.2

All U.S. patent applications directly or indirectly claiming priority to the
abovereferenced patents or applications, including divisionals, continuations,
and claims in continuations-in-part applications that are entitled to the
priority filing date of any of the above;

 

2.8.3

Foreign equivalent applications;

 

2.8.4

Patents issuing from the above applications;

 

2.8.5

Reissues, re-examinations and extensions of the above, supplementary protection
certificates and any patents issuing therefrom; and

 

2.8.6

Any of the foregoing during reissue, re-examination, or post grant review
proceedings.

2.9

The terms Sale, Sold, Sell: Any transaction in which a Licensed Product is
exchanged or transferred for value, including without limitation sales, leases,
licenses, rentals, provision of services through the use of Licensed Products,
and other modes of distribution or transfer of a Licensed Product or its
beneficial use. A Sale of a Licensed Product will be deemed to have been made
when Assembly or its Sublicensee (or anyone acting on behalf of or for the
benefit of Assembly or any of its Sublicensees) first invoices, ships, or
receives value for a Licensed Product, whichever is earliest.

2.10

Sublicensee: A non-Affiliate third party to whom Assembly has granted a
Sublicense pursuant to and in accordance with Article 3 of this Agreement.
“Sublicense” is an arms- length agreement in which Assembly:

 

2.10.1

Grants or sublicenses any of the rights granted hereunder;

 

2.10.2

Agrees not to assert the Patent Rights or agrees not to sue, prevent, or seek a
legal remedy for the practice of same; or

 

2.10.3

Has agreed to do any of the foregoing, including but not limited to licenses,
option agreements, right of first refusal agreements, standstill agreements,

Exhibit 2.8-3

--------------------------------------------------------------------------------

 

 

settlement agreements, co-development agreements, co-promotion agreements, joint
venture agreements, or other agreements.

2.12

Term: Commencing on the Effective Date and continuing until the expiration of
the last to expire of the patents in the Patent Rights unless earlier terminated
in accordance with this Agreement.

2.14

Valid Claim: A claim of a pending Patent Rights patent application or of an
issued and unexpired Patent Rights patent, in each case that has not lapsed or
been held revoked, invalid or unenforceable by a court or other governmental
agency of competent jurisdiction in a decision or order that is not subject to
appeal, provided that if a pending patent application has not issued within five
(5) years from receiving a first US office action or foreign equivalent, the
claims of such patent application will no longer be considered Valid Claims
hereunder.

 

3.3.2

If Assembly voluntarily enters bankruptcy or receivership, or if an involuntary
bankruptcy action is filed against Assembly and not dismissed within ninety (90)
days, then upon notice from IURTC, royalties based on Sublicensee’s Net Sales
and Sublicensing Revenue then or thereafter due to Assembly will become directly
due and owing to IURTC for the account of Assembly. IURTC will remit to Assembly
any amounts received that exceed the sum actually owed by Assembly to IURTC.

3.4

IURTC and the Institutions retain the right to practice under the Patent Rights
for noncommercial educational and research purposes and permit other
universities and nonprofit research institutes to do the same for non-commercial
educational and research purposes. Assembly may not in any way restrict the
rights of IU, other universities or non-profit research institutions, or their
faculty, staff, students, or employees from publishing the results of their
research related to the Patent Rights.

3.6

In accordance with 35 U.S.C. §§ 200-212, 37 C.F.R. Part 401, and in the relevant
government research contracts with the Institutions, the United States
government retains certain rights to inventions arising from federally supported
research or development. Under these laws and implementing regulations, the
government may impose requirements on such inventions. To the extent applicable,
such rights and requirements include without limitation (i) the grant of a
nonexclusive, nontransferable, irrevocable, paid-up license to practice or have
practiced for or on behalf of the government any of the Patent Rights throughout
the world, and (ii) the requirement that Licensed Products used or sold in the
U.S. will be manufactured substantially in the U.S. The rights granted in this
Agreement are expressly made subject to these laws and regulations as they may
be amended from time to time. Assembly will be required to abide by all
applicable laws and regulations. IURTC agrees to cooperate with Assembly in
connection with attempting to secure any waiver of any obligations under 35
U.S.C. §204.

Exhibit 2.8-4

--------------------------------------------------------------------------------

 

3.7

Assembly will mark all Licensed Products made or sold in the United States in
accordance with 35 U.S.C. §287(a), and will mark all Licensed Products made or
sold in other countries in accordance with the laws and regulation then
applicable in each such country.

6.2

Assembly will deliver to IURTC, with each payment made under paragraph 6.1, a
written report describing the purpose of the payment and setting forth the
calculation of the payment being made to IURTC, including the following:

 

6.2.1

For payments under paragraph 5.1, calculations of payments due in connection
with Net Sales by Assembly, by each Affiliate, and by each Sublicensee on a
country-by-country basis: the number of Licensed Products Sold; gross receipts
for Sales; deductions as described in paragraph 2.6, giving totals by each type;
and Net Sales.

 

6.2.2

For payments under paragraph 5.1 and 5.4, the serial numbers of the patent
applications and patents in the Patent Rights that in Assembly’s good-faith
determination cover each Licensed Product.

 

6.2.3

For payments under paragraph 5.2, a description and list of amounts credited
against the diligence maintenance fee.

 

6.2.4

For payments under paragraph 5.3, the name of the Sublicensee paying the
Sublicensing Revenue to Assembly.

6.3

Assembly will maintain complete and accurate books of account and records that
would enable an independent auditor to verify the amounts paid under this
Agreement, and for otherwise verifying its performance hereunder. The books and
records will be maintained for three (3) years following the quarter after
submission of the reports required by this Article. Upon reasonable notice by
IURTC, Assembly will give IURTC (or auditors or inspectors appointed by and
representing IURTC) access to all books and records for Sales of Licensed
Products to conduct, at IURTC’s expense, an audit or review of those books and
records. This access will be available no more than once every calendar year,
during regular business hours, during the Term and for the three calendar years
following the year in which termination or expiration occurs. Any underpayment
will be promptly paid, with interest as set forth in paragraph 6.4, to IURTC.
Any overpayment will be granted to Assembly as a credit against future payment.
If the audit or review reports an underpayment by five percent (5%) or more for
any fiscal quarter, Assembly will promptly reimburse IURTC for the costs and
expenses of the accountants and auditors in connection with the review and
audit.

7

Confidentiality:

7.1

The terms and conditions of Articles 4 and 5 and information exchanged between
the Parties under Articles 4, 6, and 9, as well as any information designated by
a Party in any reasonable manner as confidential within a reasonable time after
it is delivered to the receiving Party, are Confidential Information.

Exhibit 2.8-5

--------------------------------------------------------------------------------

 

7.2

During the Term and for a period of three (3) years thereafter, the receiving
Party agrees to maintain in secrecy and not disclose to any third party any
Confidential Information received, and to use reasonable measures to ensure the
confidentiality of such Confidential Information. Receiving Party will use the
Confidential Information received solely as necessary to perform its obligations
and exercise its rights in accordance with the terms and conditions of this
Agreement.

7.3

Confidential Information does not include information that:

 

7.3.1

Is or becomes publicly known through no fault of the receiving Party;

 

7.3.2

Was known to the receiving Party before disclosure by the disclosing Party as
established by documentary evidence;

 

7.3.3

Is identical subject matter originally and independently developed by the
receiving Party’s personnel without knowledge or use of or access to any
disclosing Party’s Confidential Information as established by documentary
evidence; or

 

7.3.4

Was disclosed to the receiving Party without restriction by a third party having
a right to make the disclosure.

7.4

Notwithstanding the other terms of this Article 7,

 

7.4.1

Assembly may, to the extent necessary, use Confidential Information to secure
governmental approval to clinically test or market a Licensed Product, to comply
with a court order or governmental rule or regulation, or to show to a potential
or actual sublicensee, contractor, investor, acquirer or professional adviser,
subject to an appropriate confidentiality agreement (or in the case of
professional advisers, ethical obligations). Assembly will, in any such use,
take all reasonably available steps to maintain confidentiality of the disclosed
information and to guard against any further disclosure.

 

7.4.2

IURTC may report consideration received under this Agreement and Assembly’s
progress under Article 4, including providing the Development Plans and reports,
to the Institutions and the Inventors.

7.5

Neither Party may use the name of the other for any commercial, advertisement,
or promotional purpose without the prior written consent of the other. Assembly
may not use the name of the Institutions for any commercial, advertisement, or
promotional purpose without the prior written consent of the Institutions.
However, each Party may state that Assembly licensed from IURTC one or more of
the patent applications and/or patents in the Patent Rights and may further
include (i) Institutions’ Inventors’ names, (ii) invention titles and summaries,
(iii) Field, and (iv) type and extent of license. The foregoing shall not
restrict either Party from making disclosures or statements as required by law
or regulation.

Exhibit 2.8-6

--------------------------------------------------------------------------------

 

8.5

It is understood that IURTC and Assembly are subject to United States laws and
regulation (including the Arms Export Control Act, as amended, and the Export
Administration Act of 1979) controlling the export of technical data, computer
software, laboratory prototypes, and other commodities, and that such
obligations hereunder are contingent upon compliance with applicable U.S. export
laws and regulations. The transfer of certain technical data and commodities may
require a license from the cognizant agency of the U.S. Government and/or
written assurances by Assembly that Assembly will not export data or commodities
to certain foreign countries without prior approval of such agency. IURTC does
not represent that a license is not required, or that, if required, such a
license will be issued.

8.6

It is understood that IURTC and Assembly are subject to United States and
foreign laws and regulations prohibiting bribery, including, but not limited to,
the U.S. Foreign Corrupt Practices Act of 1977, as amended, and that the
obligations of IURTC and Assembly under this Agreement are contingent upon
compliance with the U.S. Foreign Corrupt Practices Act. IURTC is not obligated
to take any action that it believes in good faith may cause it to be in
violation of the U.S. Foreign Corrupt Practices Act or other U.S. laws.

9.7

Assembly and IURTC agree that the Patent Rights will be extended by all means
provided by law or regulation, including without limitation extensions provided
under United States law at 35 U.S.C. §154(b) and 156. Assembly hereby agrees to
provide IURTC with all necessary assistance in securing such extension,
including without limitation, providing all information regarding applications
for regulatory approval, approvals granted, and the timing of same. Assembly
acknowledges that extension under 35 U.S.C. §156 must be applied for within
sixty (60) days of the date that a Licensed Product receives permission under
the provision of law under which the applicable regulatory review period
occurred for commercial marketing or use, and that Assembly’s failure to
promptly provide the necessary information or assistance to IURTC during such
sixty day period will cause serious injury to IURTC, for which Assembly will be
liable at law.

 

11

Indemnification:

11.1

Assembly will indemnify, defend, and hold harmless IURTC, the Institutions,
their respective Board of Directors, trustees, employees, the Institutions’
faculty, staff, employees, students, successors, assigns, independent
contractors, and agents (collectively, “IURTC Indemnitees”) from and against any
and all judgments, liabilities, losses, or damages, (including all attorney fees
and costs incurred by IURTC Indemnitees) (collectively, “Losses”) in connection
with any actions or claims brought by any third party arising out of, relating
to, or incidental to the exercise of any rights or breach of any term or
condition under this Agreement by Assembly or its Affiliates, successors or
assigns, or Sublicensees (provided, however, that Assembly will have no
obligation pursuant to the foregoing with respect to any Losses that result
solely and exclusively from the gross negligence or willful misconduct of any
IURTC Indemnitee), including but not limited to:

 

11.1.1

The use of any Patent Rights in the design, development, production,
manufacture, sale or offer for sale, use, importation, lease, marketing or
promotion of any Licensed Product;

Exhibit 2.8-7

--------------------------------------------------------------------------------

 

 

11.1.2

Injury or death to any person, damage to property, or any injury to business,
including, but not limited to, business interruption or damage to reputation,
arising out of, relating to, or incidental to the use of the Patent Rights or a
Licensed Product; and

 

11.1.3

Any third party claim that any use or licensing of the Patent Rights or
development, provision, or use of Licensed Products violates or infringes a
third party’s intellectual property rights.

11.2

Assembly at its sole expense will defend third party claims. Assembly will have
the right to conduct the defense of such actions. Assembly will consult with
IURTC prior to and in conjunction with all significant issues, will keep IURTC
informed of all proceedings, and will provide copies to IURTC of all pleadings,
legal analyses, and other papers related to such actions. IURTC will provide
reasonable assistance to Assembly in defending any such actions and IURTC
Indemnitees may be represented by counsel of its choosing at its expense.
Assembly will not settle or compromise any claim or action in a manner that
imposes restrictions or obligations on IURTC Indemnitees or requires any
financial payment or admission of liability by IURTC Indemnitees.

11.3

If Assembly fails to defend a claim or action for which it is required to
provided indemnification under this Article 11 within twenty (20) days of
learning of the same, in addition to and not in lieu of other rights and
remedies, IURTC may assume the defense for the account of and at the risk of
Assembly, and any resulting liability, including attorney fees, will be deemed
conclusively to be a liability of Assembly. Assembly’s failure or refusal to act
is a material breach of this Agreement. If it is determined by a court of
competent jurisdiction that such claim is not within Assembly’s indemnification
obligations under this Article 11 the foregoing will not apply, Assembly’s
failure or refusal to act will not be deemed a material breach, and any
termination will be reversed.

12

Insurance:

12.1

Assembly will at all times comply, through insurance, with all statutory
workers’ compensation and employers’ liability requirements covering all
employees with respect to activities undertaken in performance of this
Agreement.

12.2

In addition to the foregoing, Assembly and Sublicensees will obtain and maintain
commercial general liability insurance with a reputable and financially secure
insurance carrier prior to making, using, importing, offering to sell, or
selling any Licensed Product, or engaging in any other act involving any
Licensed Product or the Patent Rights, if such act could possibly create risk of
a claim against IURTC Indemnitees for personal injury or property damage.

 

12.2.1

The insurance will identify IURTC as an additional insured and will provide that
the carrier will notify IURTC in writing at least thirty (30) days prior to
cancellation or material change in coverage.

 

12.2.2

The insurance will include coverage for product liability with a minimum of two
million dollars ($2,000,000) per occurrence and five million dollars
($5,000,000)

Exhibit 2.8-8

--------------------------------------------------------------------------------

 

 

annual aggregate, coverage for contractual liability, and all other coverages
standard for such policies.

 

12.2.3

Insurance policies purchased to comply with this Article will be kept in force
for at least five (5) years after the last Sale of Licensed Product.

12.3

At IURTC’s request, such request to be made no more than annually, Assembly will
provide IURTC with a certificate of insurance and notices of subsequent renewals
for its insurance and that of any Sublicensee.

12.4

The specified minimum coverages and other provisions of this Article 12 do not
constitute a limitation on Assembly’s obligation to indemnify the IURTC
Indemnitees under this Agreement.

14.2

The rights granted in this Agreement may not be encumbered, pledged, or
hypothecated in any way by Assembly or any Sublicensee, including but not
limited to secure any purchase, lease, or loan.

16.6

The provisions of this Agreement are severable in that if any provision in the
Agreement is finally determined by a court of competent jurisdiction to be
invalid or unenforceable, such invalidity or non-enforceability will not in any
way affect the validity or enforceability of the remaining provisions or the
validity or enforceability of such provision in any jurisdiction where valid and
enforceable. Any invalid or unenforceable provision will be reformed by the
Parties to effectuate their intent as evidenced on the Effective Date.

16.8

Assembly agrees that in the event an Institution’s faculty or staff member
serves Assembly in the capacity of consultant, officer, employee, board member,
advisor, or other designation, pursuant to contract or otherwise, such
Institution’s faculty or staff member is subject to compliance with
Institution’s conflict of interest and conflict of commitment policies,
including the obligation to complete a disclosure therefor, will serve in his or
her individual capacity, as an independent contractor, and not as an agent or
representative of IURTC or Institutions, that IURTC or Institutions exercises no
authority or control over such faculty or staff member while acting in such
capacity, that IURTC or Institutions receives no benefit from such activity, and
that IURTC or Institutions assume no liability or obligation in connection with
any such work or service undertaken by such faculty or staff member. Assembly
further agrees that any breach, error, or omission by an Institutions faculty or
staff member acting in the capacity set forth above in this paragraph will not
be imputed or otherwise attributed to IURTC or Institutions, and will not
constitute a breach of this Agreement by IURTC.

 

Exhibit 2.8-9

--------------------------------------------------------------------------------

 

Exhibit 11.4

JOINT PRESS RELEASE

 

[See attached.]

 

 

Exhibit 11.4 -1

--------------------------------------------------------------------------------

CONFIDENTIAL

 

Press Release Targeted: Monday, July 20, 2020 at 3:30 am PT / 6:30 am ET

 

 

[glsa0uz20nmn000001.jpg]

[glsa0uz20nmn000002.jpg]

 

Assembly Biosciences and BeiGene Announce License and Collaboration Agreement in
China for Assembly’s Portfolio of Three Clinical-Stage Core Inhibitors for
Chronic Hepatitis B Infection

 

-- BeiGene acquires exclusive development and commercialization rights to
ABI-H0731, ABI-H2158, and ABI-H3733 in China --

-- Assembly receives $40 million upfront payment and is eligible to receive

up to $500 million in potential development, regulatory, and sales milestone
payments plus royalties on product sales --

-- Assembly to host webcast and conference call today at 8:30 am ET --

 

SOUTH SAN FRANCISCO, Calif., BEIJING, China and CAMBRIDGE, Mass, July 20, 2020
(GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB) and BeiGene, Ltd.
(NASDAQ: BGNE; HKEX: 06160), today announced that the companies have entered
into a collaboration in China for Assembly’s portfolio of three clinical-stage
core inhibitor candidates for the treatment of patients with chronic hepatitis B
virus (HBV) infection.

 

Under the terms of the agreement, Assembly has granted BeiGene exclusive rights
to develop and commercialize ABI-H0731, ABI-H2158 and ABI-H3733 in China,
including Hong Kong, Macau, and Taiwan. ABI-H0731 and ABI-H2158 are both in
ongoing Phase 2 clinical trials and ABI-H3733 is in Phase 1 development. BeiGene
will be responsible for development, regulatory submissions, and
commercialization in China. Assembly retains full worldwide rights outside of
the partnered territory for the Company’s HBV portfolio.

 

Assembly will receive an upfront cash payment of $40 million and is eligible to
receive up to approximately $500 million in potential development, regulatory
and net sales milestone payments pending successful development and
commercialization of the licensed candidates. In addition, Assembly is eligible
to receive tiered royalties of net sales. BeiGene will contribute initial
funding for clinical development in China, after which the development costs for
the territory will be shared equally by the parties.

 

“This collaboration with Assembly expands our portfolio beyond oncology to liver
diseases, which are highly prevalent and represent a high unmet need in China,”
said John Oyler, Co-Founder, Chairman and Chief Executive Officer of BeiGene.
“We are thrilled to collaborate with the Assembly team that has industry-leading
expertise in this area to advance novel treatments for hepatitis B, with the
ultimate goal of developing a cure. Since one-third of the world’s individuals
living with chronic hepatitis B are in China, we are committed to leveraging our
capabilities to further develop these novel therapies for patients with HBV
infection.”

 

“Our goal for China has been to find a strong, trustworthy partner with a proven
track record, and we are excited to collaborate with the experienced team at
BeiGene, a premier scientific partner in

1

--------------------------------------------------------------------------------

CONFIDENTIAL

 

Press Release Targeted: Monday, July 20, 2020 at 3:30 am PT / 6:30 am ET

 

our industry,” said John McHutchison, AO, MD, Chief Executive Officer and
President of Assembly Biosciences. “BeiGene has world-class operations in China,
enabling us to accelerate the clinical development and commercialization of our
core inhibitors for this important market as well as globally. With up to 90
million individuals infected with HBV in China and given the significant unmet
medical need, we and BeiGene are committed to advancing our novel core
inhibitors for patients living with this chronic disease.”

 

Assembly currently projects its $249 million in cash at March 31, 2020, together
with these additional near-term sources of funding, will extend its funding of
operations into the second half of 2022.  

 

Goldman Sachs & Co. LLC is acting as exclusive financial advisor to Assembly
Biosciences.

 

Assembly’s Webcast and Conference Call Today

Management from Assembly Biosciences will host a webcast and conference call
today at 5:30 am PT / 8:30 am ET. The live audio webcast with accompanying
slides may be accessed through the “Events & Presentations” page in the
“Investors” section of Assembly’s website at
https://investor.assemblybio.com/events-presentations. Alternatively,
participants may dial (866) 438-0453 (domestic) or (409) 220-9366
(international) and refer to conference ID 4380778. Call participants are
encouraged to connect at 5:15 am PT / 8:15 am ET to ensure a timely connection
to the call or to utilize the webcast link for listen-only access.

 

The archived webcast will be available on Assembly’s website beginning
approximately two hours after the event and will be archived and available for
replay for at least 30 days after the event.

 

About Assembly Biosciences’ HBV Core Inhibitor Portfolio
Assembly’s HBV portfolio includes three clinical-stage small molecule
candidates, all of which are HBV core inhibitors that target multiple steps of
the HBV lifecycle. In Phase 2 clinical trials, first-generation core inhibitor
ABI-H0731 administered with nucleos(t)ide analogue reverse transcriptase
inhibitor (NrtI) therapy has been well-tolerated, has shown statistically
superior antiviral activity in HBV DNA suppression compared to NrtI therapy
alone, and has demonstrated significant declines in pgRNA that may indicate
decreased cccDNA levels. In the ongoing Phase 2 open-label extension trial,
Assembly is beginning to transition patients off combination therapy, to then
monitor for sustained virologic response (SVR).  

 

Assembly’s HBV portfolio also includes two more potent, second-generation
candidates, ABI-H2158 in a Phase 2 clinical trial and ABI-H3733 in Phase 1
development.

 

Clinical data from ABI-H0731 and ABI-H2158 have been selected for presentation
at the European Association for the Study of the Liver’s (EASL) Digital
International Liver Congress, August 27-29, 2020.

 

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver
that afflicts over 250 million people worldwide with up to 90 million people in
China, as estimated by the World Health

2

--------------------------------------------------------------------------------

CONFIDENTIAL

 

Press Release Targeted: Monday, July 20, 2020 at 3:30 am PT / 6:30 am ET

 

Organization. HBV is a global epidemic that affects more people than hepatitis C
virus (HCV) and HIV infection combined—with a higher morbidity and mortality
rate. HBV is a leading cause of chronic liver disease and need for liver
transplantation, and up to one million people worldwide die every year from
HBV-related causes.

 

The current standard of care for patients with chronic HBV infection is
life-long suppressive treatment with medications that reduce, but do not
eliminate, the virus, resulting in very low cure rates. There is a significant
unmet need for new therapies to treat HBV.

 

About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing
innovative therapeutics targeting hepatitis B virus (HBV) and diseases
associated with the microbiome. The HBV program is focused on advancing a new
class of potent, oral core inhibitors that have the potential to increase cure
rates for chronically infected patients. The microbiome program is developing
novel oral live microbial biotherapeutic candidates with Assembly’s fully
integrated platform, including a robust process for strain identification and
selection, GMP manufacturing expertise and targeted delivery to the lower
gastrointestinal tract with the GEMICEL® technology. For more information,
visit assemblybio.com.

 

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on
discovering, developing, manufacturing, and commercializing innovative medicines
to improve treatment outcomes and access for patients worldwide. Its 4,100+
employees in China, the United States, Australia, and Europe are committed to
expediting the development of a diverse pipeline of novel therapeutics for
cancer. BeiGene currently markets two internally-discovered oncology products:
BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and
anti-PD-1 antibody tislelizumab in China. BeiGene also markets or plans to
market in China additional oncology products licensed from Amgen Inc., Celgene
Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn
more about BeiGene, please visit www.beigene.com and follow on Twitter at
@BeiGeneUSA.

3

--------------------------------------------------------------------------------

CONFIDENTIAL

 

Press Release Targeted: Monday, July 20, 2020 at 3:30 am PT / 6:30 am ET

 

Assembly’s Forward-Looking Statements
The information in this press release contains forward-looking statements that
are subject to certain risks and uncertainties that could cause actual results
to materially differ from those projected or implied. These risks and
uncertainties include: Assembly and BeiGene’s ability to initiate and complete
clinical trials for ABI-H0731, ABI-H2158, and ABI-H3733 in the currently
anticipated timeframes in China; safety and efficacy data from clinical studies
may not warrant further development of Assembly’s core inhibitor product
candidates; the products subject to the collaboration may not achieve future
milestones or be eligible for royalties; ABI-H0731, ABI-H2158 and ABI-H3733 may
not receive regulatory approval under the currently anticipated timelines, or at
all; Assembly’s core inhibitor products may not be differentiated from other
companies’ candidates; Assembly may not observe sustained virologic response
(SVR) in patients who are treated with its core inhibitors; and other risks
identified from time to time in Assembly’s reports filed with the U.S.
Securities and Exchange Commission (the SEC). All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. Readers are cautioned not to rely on these
forward-looking statements. Assembly intends such forward-looking statements to
be covered by the safe harbor provisions contained in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. More information about the risks and uncertainties
faced by Assembly are more fully detailed under the heading “Risk Factors” in
Assembly’s filings with the Securities and Exchange Commission, including its
most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K. Except as required by law, Assembly assumes no
obligation to update publicly any forward-looking statements, whether resulting
from new information, future events or otherwise.

 

BeiGene’s Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and other federal securities
laws, including statements regarding future development and potential
commercialization of the licensed product candidates; potential payments payable
to Assembly; the potential of the licensed product candidates to treat and
possibly achieve SVR in HBV patients; and the parties’ commitments and the
potential benefits of the collaboration. Actual results may differ materially
from those indicated in the forward-looking statements as a result of various
important factors, including BeiGene's ability to demonstrate the efficacy and
safety of its drug candidates; the clinical results for its drug candidates,
which may not support further development or marketing approval; actions of
regulatory agencies, which may affect the initiation, timing and progress of
clinical trials and marketing approval; BeiGene's ability to achieve commercial
success for its marketed products and drug candidates, if approved; BeiGene's
ability to obtain and maintain protection of intellectual property for its
technology and drugs; BeiGene's reliance on third parties to conduct drug
development, manufacturing and other services; BeiGene’s limited operating
history and BeiGene's ability to obtain additional funding for operations and to
complete the development and commercialization of its drug candidates; the
impact of the COVID-19 pandemic on the Company’s clinical development,
commercial and other operations, as well as those risks more fully discussed in
the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on
Form 10-Q, as well as discussions of potential risks, uncertainties, and other
important factors in BeiGene's subsequent filings with the U.S. Securities and
Exchange Commission. All information

4

--------------------------------------------------------------------------------

CONFIDENTIAL

 

Press Release Targeted: Monday, July 20, 2020 at 3:30 am PT / 6:30 am ET

 

in this press release is as of the date of this press release, and BeiGene
undertakes no duty to update such information unless required by law.

 

Assembly Contacts

Investors and Media:

Lauren Glaser

Senior Vice President, Investor Relations and Corporate Affairs

(415) 521-3828

lglaser@assemblybio.com

 

Amy Figueroa, CFA

Investor Relations Consultant

(415) 366-5158

afigueroa@assemblybio.com 

 

Solebury Trout

Luke Brown

(646) 378-2944

lbrown@troutgroup.com

 

BeiGene Contacts

Investors:

Craig West or Gabrielle Zhou

(857) 302-5189 or +86 010 8514 8822

ir@beigene.com

 

Media:

Liza Heapes or Vivian Ni

(857) 302-5663 or (857) 302-7596

media@beigene.com

 

# # #

 

5

--------------------------------------------------------------------------------

 

EXHIBIT 14.6

UPSTREAM LICENSE PROVISIONS

RELATED TO IP PROSECUTION AND ENFORCEMENT

 

2

Definitions: For the purposes of this Exhibit 2.8 and the Agreement, the
following words and phrases have the meanings assigned to them below. Please
refer to Exhibit 2.8 for the definition of other capitalized terms.

“Agreement” referenced in this Exhibit 2.8 refers to the Upstream License.

2.1

Field: Diagnostics and therapeutics.

2.2

Licensed Product: Any product: (i) the making, using or selling of which, absent
the license granted hereunder, would infringe one or more pending or issued
Valid Claims (without giving effect to any safe harbor from infringement under
35 U.S.C. 271 (e)(1)); or (ii) that is made by, uses, or is used by a process
that, absent the license granted hereunder, would infringe one or more pending
or issued Valid Claims.

2.3

Patent Rights:

 

2.3.1

The patent applications (including provisionals) filed or to be filed as listed
on Exhibit A;

 

2.3.2

All U.S. patent applications directly or indirectly claiming priority to the
abovereferenced patents or applications, including divisionals, continuations,
and claims in continuations-in-part applications that are entitled to the
priority filing date of any of the above;

 

2.3.3

Foreign equivalent applications;

 

2.3.4

Patents issuing from the above applications;

 

2.3.5

Reissues, re-examinations and extensions of the above, supplementary protection
certificates and any patents issuing therefrom; and

 

2.3.6

Any of the foregoing during reissue, re-examination, or post grant review
proceedings.

2.4

Sublicensee: A non-Affiliate third party to whom Assembly has granted a
Sublicense pursuant to and in accordance with Article 3 of this Agreement.
“Sublicense” is an arms- length agreement in which Assembly:

 

2.4.1

Grants or sublicenses any of the rights granted hereunder;

 

2.4.2

Agrees not to assert the Patent Rights or agrees not to sue, prevent, or seek a
legal remedy for the practice of same; or

Exhibit 14.6 - 1

--------------------------------------------------------------------------------

 

 

2.4.3

Has agreed to do any of the foregoing, including but not limited to licenses,
option agreements, right of first refusal agreements, standstill agreements,
settlement agreements, co-development agreements, co-promotion agreements, joint
venture agreements, or other agreements.

2.12

Term: Commencing on the Effective Date and continuing until the expiration of
the last to expire of the patents in the Patent Rights unless earlier terminated
in accordance with this Agreement.

2.13

Territory: Anywhere in the world, except those countries to which export of
technology or goods is prohibited by applicable United States export control
laws or regulations.

2.14

Valid Claim: A claim of a pending Patent Rights patent application or of an
issued and unexpired Patent Rights patent, in each case that has not lapsed or
been held revoked, invalid or unenforceable by a court or other governmental
agency of competent jurisdiction in a decision or order that is not subject to
appeal, provided that if a pending patent application has not issued within five
(5) years from receiving a first US office action or foreign equivalent, the
claims of such patent application will no longer be considered Valid Claims
hereunder.

9.1

IURTC is the owner or co-owner of the Patent Rights and will have exclusive
control of the preparation, filing, prosecution, issue, and maintenance of the
Patent Rights. Maintenance includes but is not limited to post-issuance
proceedings such as post-grant reviews, reissue proceedings, and re-examination
proceedings. IURTC will select qualified patent counsel reasonably acceptable to
Assembly to prepare, file, prosecute and maintain the Patent Rights. IURTC will
keep Assembly fully informed of patent prosecution, will seek Assembly’s
comments and suggestions prior to taking material actions for the same, and will
take all prosecution actions reasonably recommended by Assembly which would
expand the scope of rights sought.

9.8

Notwithstanding anything in this Agreement to the contrary, the Parties
acknowledge and agree that for the patent applications listed on Exhibit A that
are identified as “Protein Modulator Patents” (including all associated Patent
Rights) (such patent applications and associated Patent Rights, collectively,
the “Protein Modulator Patent Rights”)  that Assembly is a co-owner of the
Protein Modulator Patent Rights and, notwithstanding anything in Sections 9.1
through 9.7 to the contrary, the Parties agree that:

 

9.8.3

Assembly will not abandon the prosecution of any patent application or the
maintenance of any patent under the Protein Modulator Patent Rights without
prior written notice to IURTC. Upon receiving such written notice, IURTC, at its
sole option, may take over the prosecution of any such patent application or the
maintenance of any such issued patent in accordance with Sections 9.1 through
9.7.

Exhibit 14.6 - 2

--------------------------------------------------------------------------------

 

10.Third Party Infringement:

10.1

The Parties will give prompt written notice to each other of any known or
suspected infringement of the Patent Rights by a third party. Assembly at its
sole expense has the right to attempt to abate any infringement of the Patent
Rights in the Field. Assembly may initiate and prosecute actions against third
parties for infringement and/or unfair trade practices, and if required by law,
IURTC will permit any action to be brought in its name, including being joined
as a party-plaintiff. Assembly will consult with IURTC prior to and in
conjunction with all significant issues, will keep IURTC informed of all
proceedings, and will provide copies to IURTC of all pleadings, legal analyses,
and other papers related to such actions. IURTC will provide reasonable
assistance to Assembly in prosecuting any such actions and will be compensated
by Assembly for its reasonable out-of-pocket expenses, which IURTC will only be
required to expend if Assembly has approved same for reimbursement. Absent
IURTC’s prior written consent, Assembly will not settle or compromise any claim
or action in a manner that grants rights or concessions to a third party to the
Patent Rights.

10.2

Any damages paid (including without limitation statutory damages, compensatory
damages, lost profits damages, exemplary damages, increased damages, and awards
of costs and attorney fees) will first be applied to reimbursement of Assembly’s
reasonable costs, expenses, and legal fees, including amounts Assembly has
reimbursed to IURTC. Assembly will retain the remaining balance of such damages,
subject to payment to IURTC of an amount based upon a reasonable approximation
of the royalties and other amounts that Assembly would have paid to IURTC if
Assembly had sold the infringing products rather than the infringer. Any special
or punitive damages will be distributed [* * *] percent ([* * *]%) to Assembly
and [* * *] percent ([* * *]%) to IURTC.

10.3

If Assembly fails or declines to take any action under paragraph 10.1 within
sixty (60) days after learning of third party infringement or unfair trade
practices, IURTC will have the right, but not the obligation, to take
appropriate actions against any such third party at its sole expense and to
retain all recovered damages. In such instances, Assembly will cooperate as
requested by IURTC, and will be compensated by IURTC for its reasonable
out-of-pocket expenses, which Assembly will only be required to expend if IURTC
has approved same for reimbursement.

Exhibit 14.6 - 3