Exhibit 10.33

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

 

 

 

 

 

 

 

 

 

COLLABORATION AGREEMENT

by and between

BridgeBio GENE THERAPY, LLC

and

CATALENT MARYLAND, INC.

 

Dated as of December 31, 2019

 

 

 

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TABLE OF CONTENTS

 

 

Page

ARTICLE I DEFINITIVE AGREEMENTS

2

 

1.1

General

2

 

1.2

BridgeBio Manufacturing and Supply Agreement

2

 

1.3

Additional Manufacturing and Supply Agreements

3

ARTICLE II ROLES AND RESPONSIBILITIES OF THE PARTIES

3

 

3

General

3

 

3

Catalent

3

 

2.3

BridgeBio

4

 

2.4

No Obligation to Perform

4

ARTICLE III DEDICATED CLEAN ROOM SUITE; BWI FACILITY

5

 

3.1

The Dedicated Clean Room Suite.

5

 

3.2

The BWI Facility

6

ARTICLE IV STEERING COMMITTEE

6

 

6

Joint Steering Committee

6

 

4.2

Decision-Making

7

 

4.3

Periodic Status Updates

8

ARTICLE V REGULATORY MATTERS

9

 

5.1

Ownership of Regulatory Materials

9

 

5.2

Regulatory Filings and Regulatory Approvals

9

 

5.3

Communications

10

 

5.4

Reserved.

10

 

5.5

Regulatory Authority Communications Received

10

 

5.6

Environmental Audit of BWI Facility

11

ARTICLE VI LIMITATIONS AND CERTAIN RIGHTS

11

 

6.1

Limitations

11

 

6.2

Continuity of Operations

11

ARTICLE VII FORCE MAJEURE

12

 

7.1

Force Majeure Events

12

 

7.2

Examples

12

 

7.3

Process

12

ARTICLE VIII CONFIDENTIALITY

13

 

8.1

Sharing of Confidential Information

13

 

8.2

Confidential Disclosure Agreement

13

 

8.3

Confidential Information

13

 

8.4

Exceptions to Confidential Information

14

 

8.5

Confidentiality Obligations

14

 

8.6

Permitted Disclosure and Use

15

 

8.7

Notification

16

 

8.8

Publicity

16

 

8.9

Use of Names

16

 

8.10

Defend Trade Secrets Act Notice

16

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8.11

Survival

16

ARTICLE IX FINANCIAL PROVISIONS

17

 

9.1

Clean Room Reservation Fee

17

 

9.2

Clean Room Use Fee.

17

 

9.3

BridgeBio-Requested Equipment

17

 

9.4

Withholding Tax Matters

18

 

9.5

Audit

18

ARTICLE X INTELLECTUAL PROPERTY

19

 

10.1

General

19

 

10.2

License to Catalent

19

 

10.3

License to BridgeBio

19

 

10.4

Project Intellectual Property

20

 

10.5

Patent Filings; Cooperation

20

ARTICLE XI REPRESENTATIONS AND WARRANTIES

20

 

11.1

BridgeBio and Catalent Mutual Representations and Warranties

20

 

11.2

Mutual Covenants; No Debarment

21

 

11.3

Additional Representations, Warranties and Covenants by Catalent

22

 

11.4

Additional Representations, Warranties and Covenants of BridgeBio

22

 

11.5

No Other Representations or Warranties

23

 

11.6

Catalent Indemnity

23

 

11.7

BridgeBio Indemnity

24

 

11.8

Indemnification Procedures

24

 

11.9

Insurance

25

ARTICLE XII TERMINATION AND SURVIVAL

25

 

12.1

Term and Termination

25

 

12.2

Effect of Termination

26

ARTICLE XIII DISPUTE RESOLUTION

29

 

13.1

Disputes

29

 

13.2

Dispute Resolution

29

 

13.3

Patent and Trademark Dispute Resolution

30

 

13.4

Injunctive Relief

30

ARTICLE XIV MISCELLANEOUS

30

 

14.1

Assignment; Binding Effect

30

 

14.2

Expenses

30

 

14.3

Notices

31

 

14.4

Severability

32

 

14.5

Entire Agreement

32

 

14.6

Waiver

32

 

14.7

Governing Law; Jurisdiction; Venue

32

 

14.8

Headings

32

 

14.9

Counterparts

32

 

14.10

Construction

33

 

14.11

Interpretation

33

 

14.12

Relationship of the Parties

33

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Attachments

 

ADefinitions

BMinimum Annual Threshold and Forecasting

CDedicated Clean Room Suite Floor Plan

DBase Equipment Package

 

Schedules

 

2.2Summary of Key Milestones for Dedicated Clean Room Suite

3.1(b)Readiness Determination Check List

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COLLABORATION AGREEMENT

THIS COLLABORATION AGREEMENT (this “Agreement”), dated as of the 31st day of
December, 2019 (the “Effective Date”), is entered into by and among Bridgebio
gene therapy, LLC, a limited liability corporation organized and existing under
the Laws of Delaware and having a place of business at 421 Kipling Street, Palo
Alto, California 94301, (“BridgeBio”) and CATALENT MARYLAND, INC. (formerly
Paragon Bioservices, Inc.), a corporation organized and existing under the Laws
of Delaware and having a place of business at 801 West Baltimore Street, Suite
302, Baltimore, Maryland 21201 (“Catalent”).  BridgeBio and Catalent are
sometimes referred to herein, individually, as a “Party” and, collectively, as
the “Parties.”  All capitalized terms used herein, including in the Exhibits and
Schedules hereto, shall have the meanings specified in Exhibit A attached hereto
or elsewhere in this Agreement, as applicable, unless otherwise specified.

RECITALS

WHEREAS, BridgeBio and its majority- and wholly-owned subsidiaries including
ASPA Therapeutics, Inc. (“ASPA”), Adrenas Therapeutics, Inc. (“Adrenas”), and
Audition Therapeutics, Inc. (“Audition”) (BridgeBio and its subsidiaries are
collectively referred to herein as the “BridgeBio Entities” and each subsidiary
is referred to herein as “BridgeBio Entity”) are gene therapy companies that are
currently developing Adeno-associated virus (“AAV”)-delivered therapeutics for
the treatment of genetic diseases.  BridgeBio (on behalf of itself and the other
BridgeBio Entities) is interested in securing clinical and commercial scale
manufacturing capacity for the Manufacture of Batches of Bulk Drug Substance of
which the BridgeBio Entities or BridgeBio’s designated Strategic Partners may
later contract with Catalent for clinical and/or commercial supply (each such
Batch of Bulk Drug Substance being a “BridgeBio Product” and collectively the
“BridgeBio Products”);

WHEREAS, Catalent has process development, manufacturing, and related services
experience and expertise, and operates facilities for the development and
manufacturing of biopharmaceuticals, including but not limited to a clinical and
commercial scale biomanufacturing facility located at 7555 Harmans Road,
Baltimore, Maryland (the “BWI Facility”);

WHEREAS, the Parties wish to enter into a business transaction involving the
commitment by Catalent to BridgeBio of dedicated biomanufacturing space and the
execution by both Parties of various agreements governing collaboration,
development, clinical and/or commercial supply of and with respect to BridgeBio
Products (hereinafter the “Proposed Transaction”);

WHEREAS, the Proposed Transaction contemplates that during the Term the
BridgeBio Entities and Catalent will enter into manufacturing and supply
agreements for clinical and commercial supply manufacturing of one or more
BridgeBio Products (each such agreement being referred to herein as the
“BridgeBio Manufacturing and Supply Agreement”);

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WHEREAS, on August 22, 2019, ASPA and Catalent entered into an Interim Services
Agreement (“ISA”) in order to commence with the reservation, planning, and
design of the clean room suite to be dedicated to BridgeBio, initiate the
exchange of information regarding the Manufacturing Process of the BridgeBio
Products, and order long lead-time equipment (hereinafter the “Transition
Services”);

WHEREAS, on November 23, 2019, ASPA and Catalent executed the First Amendment to
the Interim Services Agreement to extend the term thereof;

WHEREAS, to consummate the Proposed Transaction, the Parties intend to execute
(i) this Agreement, which, among other things, will set forth the terms and
conditions of the overall relationship between the Parties and the dedication of
[***] at the BWI Facility for BridgeBio for a [***] period during each calendar
year for the Term of this Agreement (collectively, the “Dedicated Clean Room
Collaboration”), and (ii) one or more BridgeBio Manufacturing and Supply
Agreements; and

WHEREAS, this Agreement provides for certain rights, obligations, terms and
conditions among the Parties with respect to the Dedicated Clean Room
Collaboration.

NOW, THEREFORE, in consideration of the foregoing and the representations,
warranties, covenants, agreements and provisions set forth herein, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, and intending to be legally bound hereby, the Parties agree as
follows:

Article I
Definitive Agreements

1.1General. This Agreement, together with the BridgeBio Manufacturing and Supply
Agreement (including the Quality Agreements) and any Additional Manufacturing
and Supply Agreements are collectively referred to herein as the “Definitive
Agreements” and set forth the material terms related to the roles, allocations
of responsibilities, rights, obligations, terms and conditions for each of the
Parties’ involvement in the Dedicated Clean Room Collaboration.  

1.2BridgeBio Manufacturing and Supply Agreements. During the Term, one or more
BridgeBio Entities and Catalent will enter into one or more agreements for
development services and clinical supply Manufacture and Delivery of one or more
BridgeBio Products under which scopes of work for development services and/or
clinical supply for each BridgeBio Products will be issued (each agreement being
a “Development Services and Clinical Supply Agreement” and each scope of work
being a “Scope of Work”).  Catalent shall enter into Development Services and
Clinical Supply Agreements with ASPA, Adrenas and Audition for the development
services and/or clinical supply for products relating to the treatment,
prevention or diagnosis of Canavan Disease, Congenital Adrenal Hyperplasia, and
TMC-1-dependent genetic hearing loss (the “Existing Programs”).  The Parties
shall negotiate in good faith on commercially reasonable terms a Development
Services and Clinical Supply Agreement for at least one (1) Existing Program
within [***] of the Effective Date.  Further, it is anticipated that one or more
of the

2

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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BridgeBio Entities and Catalent will enter into one or more agreements for the
commercial supply of each BridgeBio Product for which BridgeBio submits for
Regulatory Approval (each a “Commercial Supply Agreement”).  The Development
Services and Clinical Supply Agreements and Commercial Supply Agreements are
each a BridgeBio Manufacturing and Supply Agreement.  It is the intention of the
Parties that each of the BridgeBio Entities and Catalent will enter into a
separate BridgeBio Manufacturing and Supply Agreement that is unique to the
BridgeBio Products being Developed by that BridgeBio Entity.

1.3Additional Manufacturing and Supply Agreements. In addition to the BridgeBio
Manufacturing and Supply Agreement for clinical supply of BridgeBio Products,
the Parties anticipate that additional supply agreements may be negotiated in
good faith as part of the Dedicated Clean Room Collaboration for BridgeBio’s
Strategic Partners (each such agreement being an “Additional Manufacturing and
Supply Agreement”).

Article II
Roles and Responsibilities of the Parties

2.1General.  The roles and responsibilities of each Party with respect to
activities under the Dedicated Clean Room Collaboration are as provided
herein.  The Parties understand and agree that there are significant
interdependencies by and between each Party in carrying out their respective
responsibilities under this Agreement.  This Article II is intended to give an
overview of the respective roles and responsibilities of the Parties and to
provide the appropriate context for those roles and responsibilities.

2.2Catalent. Catalent shall, by itself or through subcontractors, be responsible
for the following:

(a)Constructing the Dedicated Clean Room Suite and the Associated
Infrastructure, each of which is defined below, in a manner that (i)
accommodates the use of the BridgeBio Technology for the Manufacture of the
BridgeBio Products in compliance with cGMP requirements and the principles in
their respective Quality Agreements, and (ii) achieves the timeline attached
hereto as Schedule 2.2 or such other date(s) as BridgeBio and Catalent may agree
on in writing;

(b)Completing the qualification and other activities related to the Dedicated
Clean Room Suite and the BWI Facility (including the installation of all
equipment for use in the Dedicated Clean Room Suite);

(c)Ensuring that all equipment used in the Dedicated Clean Room Suite are
suitable for the Manufacture of BridgeBio Products in accordance with the
related Definitive Agreements;

3

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(d)Conducting all of its activities under the Dedicated Clean Room Collaboration
in good scientific manner, in compliance with all material respects of this
Agreement, all requirements of applicable Laws and Regulatory Acts and any other
requirements, and as applicable, of cGMPs;

(e)Remaining in compliance with and maintaining the necessary regulatory filings
in accordance with applicable Laws and Regulatory Acts with respect to the BWI
Facility and Dedicated Clean Room Suite; and

(f)Using commercially reasonable efforts to achieve the objectives of the
Dedicated Clean Room Collaboration efficiently and expeditiously.

2.3BridgeBio. BridgeBio shall, by itself or through subcontractors, be
responsible for the following:

(a)Providing reasonable support to Catalent in planning the Dedicated Clean Room
Suite in preparation for the Manufacture of the BridgeBio Products;

(b)Using commercially reasonable efforts to achieve the objectives of the
Dedicated Clean Room Collaboration efficiently and expeditiously;

(c)Consulting with Catalent in the planning, specification, and procurement of
BridgeBio-Requested Equipment to be deployed in the Dedicated Clean Room Suite
for the Manufacture of BridgeBio Products;

(d)To the extent within the control of BridgeBio, support the timely transfer of
BridgeBio Technology associated with the BridgeBio Products, including but not
limited to timely transferring of the Manufacturing Process, batch production
records, standard operating procedures, raw materials, and assays and analytical
methods, if applicable;

(e)Timely performance of necessary audits and inspections of the Dedicated Clean
Room Suite and installed BridgeBio-Requested Equipment to confirm readiness for
the Manufacture of the BridgeBio Products; and

(f)Promptly making all required payments set forth in this Agreement, consisting
of the following, if applicable: Clean Room Reservation Fee, Clean Room Use Fee,
BridgeBio-Requested Equipment Cost, and BridgeBio-Requested Equipment Use Fee.

2.4No Obligation to Perform.  Neither Catalent nor its Affiliates shall be
obliged to Manufacture any BridgeBio Product for sale in any countries that are
targeted by the comprehensive sanctions, restrictions or embargoes administered
by the United Nations, European Union, United Kingdom, or the United States if
it is prevented from doing so, or would be required to obtain or apply for
special permission to do so, due to any restriction (such as an embargo) imposed
on it by any Governmental Authority, including those imposed by the U.S.
Department of the Treasury’s Office of Foreign Assets Control.

4

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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Article III
Dedicated Clean Room Suite; BWI Facility

3.1The Dedicated Clean Room Suite.

(a)As part of the Dedicated Clean Room Collaboration, Catalent shall dedicate
clean room space at the BWI Facility, designated as [***] (the “Dedicated Clean
Room Suite”), for the purpose of exclusively Manufacturing BridgeBio Products
for [***] (each [***] period being a “Dedicated Manufacturing Period”),
beginning and ending at the same time each year during the Term of this
Agreement. The Parties agree that the Dedicated Manufacturing Period will
commence on [***] and conclude on [***].  The commencement and conclusion of the
Dedicated Manufacturing Period may be modified based upon the written agreement
of the Parties.  The approximate outline of the floor plan and location of the
Dedicated Clean Room Suite within the BWI Facility is set forth in Exhibit C
attached hereto.  As part of its obligation to perform Manufacturing of
BridgeBio Products in the Dedicated Clean Room Suite, Catalent shall provide the
necessary supporting cGMP infrastructure required for clean room operations,
including QC, warehousing, buffer preparation, master cell bank storage
(“Associated Infrastructure”).

(b)The Dedicated Manufacturing Period shall first commence upon the
determination by the JSC that the Dedicated Clean Room Suite and Associated
Infrastructure have been fully qualified and validated for cGMP Manufacturing of
the BridgeBio Products (such determination being a “Readiness
Determination.”)  Notwithstanding the forgoing, if the JSC approves the
commencement of Manufacturing in the Dedicated Clean Room Suite prior to the
Readiness Determination, the start date of the Manufacturing shall be deemed the
Readiness Determination.  In the event that BridgeBio desires to exclusively
secure the Dedicated Clean Room Suite for an entirety of the remaining Term, it
shall provide Catalent with a notice of its intent at least [***] prior to the
time it would like to secure the space and the Parties agree to negotiate in
good faith the exclusive access of BridgeBio to the Dedicated Clean Room Suite
for the remaining term, subject to its availability and any additional term of
fees that will be charged to BridgeBio.  The Readiness Determination shall
consider cGMP readiness of the Dedicated Clean Room Suite and Associated
Infrastructure, as provided for in Schedule 3.1(b), as well as compliance with
the applicable regulatory and quality assurance requirements for cGMP
Manufacturing. Upon the Readiness Determination, BridgeBio shall start paying
[***] use fee (payable as set forth in Section 9.2(a)) for the ongoing
operational and maintenance costs associated with the Dedicated Clean Room Suite
(as are necessary to maintain cGMP operations), which shall include, but are not
limited to, costs associated with maintenance and repairs, equipment calibration
and metrology, environmental monitoring, cleaning, solid and liquid waste
disposal, warehousing, raw material and product storage, personal protective
equipment, shipping and receiving, and utilities (such fee being the “Clean Room
Use Fee”).  

(c)As part of the Dedicated Clean Room Collaboration and more fully set forth in
Exhibit B attached hereto, the Parties have agreed to the following operational
provisions for the use of the Dedicated Clean Room Suite during the Term: (i)
minimum [***] ordering obligations for the Manufacture of clinical and/or
commercial supply of BridgeBio Products in the Dedicated Clean Room Suite
following the Readiness Determination, (ii) the establishment of procedures for
the initial forecasting and rolling forecasts of the BridgeBio Entities’
ordering of clinical and/or commercial supply Manufacturing of the BridgeBio
Products in the Dedicated Clean Room Suite, and (iii) any other services to be
performed by Catalent for BridgeBio to which the Parties mutually agree.  

5

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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

 

3.2The BWI Facility.

(a)Catalent shall maintain full and exclusive rights over the operation of the
BWI Facility and, as contemplated in this Agreement during the Dedicated
Manufacturing Period, shall use the Dedicated Clean Room Suite for the benefit
of BridgeBio for the Manufacture of the BridgeBio Products. Except that as
provided for in Section 9.2(b), Catalent may use the Dedicated Clean Room Suite
or clean rooms within the Dedicated Clean Room Suite for Manufacturing for other
Catalent customers during the Dedicated Manufacturing Period solely upon
BridgeBio’s prior written approval, provided that Catalent timely returns the
Dedicated Clean Room Suite, or clean rooms within the Dedicated Clean Room
Suite, such that the compliance with applicable Law or Manufacture of the
BridgeBio Products will not be delayed or otherwise adversely affected.

(b)[***] is responsible for all costs associated with the readiness and on-going
operation of the BWI Facility (and its systems) and the Dedicated Clean Room
Suite.  If BridgeBio makes specific requests regarding the construction, layout,
commissioning, qualification and/or validation of the Dedicated Clean Room Suite
or the equipment installed in the Dedicated Clean Room Suite that are unique to
the Manufacture of BridgeBio Products, Catalent agrees to reasonably consider
such requests [***].  If [***] Catalent will implement the requested changes.

Article IV
Steering Committee

4.1Joint Steering Committee.  The Parties have established a Joint Steering
Committee (the “Joint Steering Committee,” or “JSC”) comprised of
representatives of the Parties.  The JSC has and will continue to oversee and
coordinate all aspects of (x) the Dedicated Clean Room Collaboration, and
(y) the Definitive Agreements.  The JSC will periodically meet in person, by
videoconference or teleconference.  Among the activities for oversight by the
JSC are the following:

(a)Review, coordinate and discuss the overall plans for (i) completing and
maintaining the Dedicated Clean Room Suite, (ii) the use of the Dedicated Clean
Room Suite for the Manufacture of BridgeBio Products, and (iii) forecasting,
ordering and delivery of Products;

(b)Review plans and timelines, and any amendments thereto, for the layout and
process flows in the Dedicated Clean Room Suite;

(c)Review matters related to potential regulatory approvals of the BWI Facility
and any post-regulatory approval commitments for the BWI Facility related to the
Manufacture of BridgeBio Products;

(d)Planning and scheduling the Manufacturing of BridgeBio Products in the
Dedicated Clean Room Suite on a quarterly and annual basis;

6

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(e)Review Catalent’s risk assessments relating to operations, employees,
technology, suppliers, inventory policy, emergency plans related to the
Dedicated Clean Room Suite;

(f)Undertake annually, if not more frequently, review the BridgeBio Product
Manufacturing costs and Procurement Costs and develop and implement plans to
reduce the BridgeBio Product Manufacturing costs and Procurement Costs and, if
such cost reductions or savings are actually realized, establish a process for
the sharing of such cost reductions and savings;

(g)Review the BridgeBio Entities’ proposed product pipeline and any potential
Strategic Partners under consideration, and discuss potential conflicts with
Catalent’s then-existing obligations to Third Parties;

(h)Undertake such other matters as expressly indicated by this Agreement; and

(i)Undertake such other matters as may be mutually agreed in writing by the
Parties.

The JSC shall not have the power to take any action to interpret, amend or
modify the Definitive Agreements, or waive compliance therewith.  The Parties
acknowledge and agree to establish sub-committees of the JSC and/or additional
operational committees, as appropriate and as mutually agreed upon, that may be
delegated or otherwise assigned the governance or operational responsibilities
set forth above and that are more narrowly focused on issues relating to a
particular BridgeBio Products or group of BridgeBio Products, such as a joint
manufacturing committee.

4.2Decision-Making.

(a)The decisions of the JSC with respect to matters subject to its
decision-making authority shall be made as set forth in this Section 4.2 and
shall be final.  Subject to and after giving effect to the provisions of Section
4.2(b), all decisions of the JSC will be made by unanimous vote or written
consent, with BridgeBio and Catalent each having, collectively among its
respective members, one (1) vote in all decisions, such decision to be
documented in the meeting minutes.  The JSC shall use commercially reasonable
efforts to resolve the matters within its roles and functions or otherwise
referred to it with due regard to the Dedicated Clean Room Collaboration and
Definitive Agreements.  If the JSC cannot reach consensus on a matter within
[***] (or such longer period of time as mutually agreed by the Parties) after
such matter has been presented to the JSC, then such matter shall be handled in
the following manner.  Any disputed matter that cannot be resolved by the JSC
shall be first referred to the executive officers designated by each
Party.  Such executive officers shall use commercially reasonable efforts to
reach mutually acceptable resolutions on all such disputed matters.  If such
executive officers are unable to resolve any disputed matter within [***] (or
such longer period of time as mutually agreed by the Parties) after the dispute
is first referred to them, the matter shall be resolved as provided in Section
4.2(b).

7

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(b)If any matter within the decision-making authority of the JSC remains
unresolved following attempted resolution under Section 4.2(a), the following
shall apply:

(i)Subject to and after giving effect to the provisions of Section 4.2(b)(iv),
if the dispute relates to clinical, commercial supply or regulatory matters
regarding any BridgeBio Product, BridgeBio shall have final decision-making
authority with respect to such matters.  In the event any such matter requires
an immediate or prompt decision and the JSC is not able to reach agreement,
BridgeBio, by written notice to Catalent, may inform it of the need to
accelerate a decision on that matter and that it is electing to exercise its
decision-making authority on a shortened time frame than that set forth in
Section 4.2(a).

(ii)Subject to and after giving effect to the provisions of Section 4.2(b)(iv),
if the dispute relates to construction, commission, qualification and validation
of the BWI Facility and the Dedicated Clean Room Suite, Catalent shall have
final decision-making authority with respect to such matters, provided that
Catalent’s final decision-making authority does not include the Readiness
Determination.  In the event any such matter requires an immediate or prompt
decision and the JSC is not able to reach agreement, Catalent, by written notice
to BridgeBio, may inform it of the need to accelerate a decision on that matter
and that it is electing to exercise its decision-making authority on a shortened
time frame than that set forth in Section 4.2(a).

(iii)Subject to and after giving effect to the provisions of Section 4.2(b)(i),
(ii) and (iv), any remaining unresolved dispute regarding a matter within the
decision-making authority of the JSC shall be resolved in accordance with
Article XIII, and none of the Parties shall have any final decision-making
authority with respect to such dispute.

(iv)Notwithstanding the foregoing provisions of this Section 4.2(b): (A) either
Party’s exercise of a right to finally resolve a dispute hereunder shall not
excuse the other Party from any of its obligations specifically enumerated under
the Definitive Agreements; and (B) neither Party shall exercise such a right in
a manner that violates any rights or obligations specifically addressed in any
Definitive Agreements.  In addition, in resolving a dispute hereunder each Party
shall act in good faith.

4.3Periodic Status Updates.  Each Party shall provide the JSC with reports
detailing the activities it conducts under the Dedicated Clean Room
Collaboration on a periodic basis to be reviewed and, if appropriate, acted upon
by the JSC.  Such reports shall be provided at least five (5) Business Days
prior to the JSC meeting at which the report is scheduled to be discussed.

8

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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Article V
Regulatory Matters

5.1Ownership of Regulatory Materials.  Any and all Regulatory Materials,
including Regulatory Approvals, arising under the Dedicated Clean Room
Collaboration in respect to BridgeBio Products and the Manufacture thereof,
including labeling and packaging and any Drug Master Files and Chemistry,
Manufacturing and Control (“CMC”) (or equivalent) sections of any such
Regulatory Materials shall be in the name of the applicable BridgeBio Entity,
and such BridgeBio Entity shall own all right, title and interest in and to all
such Regulatory Materials; provided, however, that Regulatory Materials,
including Regulatory Approvals, solely relating to establishment license
approvals for the BWI Facility and the Dedicated Clean Room Suite shall be in
the name of Catalent, and Catalent shall own all right, title and interest in
and to only such Regulatory Materials, subject to and after giving effect to the
BridgeBio Entity’s right to use such establishment license approvals in
connection with its Development, Manufacturing and Commercialization activities
for the Manufacture of BridgeBio Product.

5.2Regulatory Filings and Regulatory Approvals.

(a)BridgeBio General Responsibilities.  The applicable BridgeBio Entity shall be
solely responsible for the preparation of all Regulatory Materials owned by such
BridgeBio Entity, and all costs related thereto, including as may be necessary
or desirable for obtaining and maintaining Regulatory Approvals owned by such
BridgeBio Entity.  BridgeBio and other BridgeBio Entities shall not identify
Catalent in any Regulatory Materials without Catalent’s prior written consent.
Such consent shall not be unreasonably withheld, conditioned, or delayed.    

(b)Manufacturing Approvals and BWI Facility Related Sections.  Catalent shall be
responsible for the preparation of all Regulatory Materials solely relating to
establishment license approvals for the BWI Facility and the Dedicated Clean
Room Suite for the Manufacture of BridgeBio Products under the Dedicated Clean
Room Collaboration and Definitive Agreements.  Catalent also shall prepare and
provide to the BridgeBio Entities the Regulatory Materials relating to such
establishment license approvals in a timely manner in order for the BridgeBio
Entities to comment and agree on and to use in compiling, supporting and
maintaining each BridgeBio Entity’s regulatory filings for its BridgeBio
Products.  Catalent shall provide such Regulatory Materials with the content and
in the format required by a Regulatory Authorities as well as such content and
format requested by the BridgeBio Entities.  Without limiting the foregoing and
as provided for in a Scope of Work under a BridgeBio Manufacturing and Supply
Agreement, Catalent will provide BridgeBio with available data and documentation
necessary to support a BridgeBio Entity’s submission to any Regulatory
Authority, and provide responses to questions raised by a Regulatory Authority
with respect to Manufacturing BridgeBio Products that are necessary for
Regulatory Approval of the BWI Facility as a clinical or commercial supply
manufacturing (as applicable under the respective BridgeBio Manufacturing and
Supply Agreement), testing, and packaging site for the applicable BridgeBio
Products.  To the extent that a Regulatory Approval of a BridgeBio Entity’s
Products in jurisdictions other than the U.S. or EU impose additional
requirements on Catalent, Catalent agrees to comply with such requirements, at
such BridgeBio Entity’s cost and expense, provided that compliance with the
additional requirements does not materially disrupt Catalent’s operation of the
BWI Facility.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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5.3Communications.  The BridgeBio Entities shall be primarily responsible for
communicating with any Regulatory Authority having jurisdiction anywhere in the
world regarding BridgeBio Products under the Dedicated Clean Room Collaboration;
provided, that BridgeBio shall keep the JSC reasonably and timely informed of
all such relevant communications regarding such BridgeBio Product or their
components; and Catalent shall, at no cost to the BridgeBio Entity, where
requested by the BridgeBio Entity to do so, assist the BridgeBio Entity in
communications as they pertain to the Manufacture of BridgeBio Product,
including but not limited to provision of documentation and other evidence,
preparation for and participation in any inspection and conduct of any other
activities necessary to facilitate the communications between the BridgeBio
Entity and the Regulatory Authority.  Catalent shall be responsible for
communicating with any Regulatory Authority having jurisdiction over the BWI
Facility used in the Manufacture of BridgeBio Product under the Dedicated Clean
Room Collaboration; provided, that Catalent shall, as promptly as practicable
but in no event later than the time frames agreed on in the Quality Agreement,
notify the applicable BridgeBio Entity in the event that Catalent communicates,
or intends to communicate, either on its own initiative in accordance with this
Agreement or as a result of such a Regulatory Authority initiating contact with
Catalent that may affect or involve operations associated with the Manufacture
of a BridgeBio Product, and promptly provide the BridgeBio Entity with a copy of
all such communications.

5.4Reserved.

5.5Regulatory Authority Communications Received.

(a)General.  Catalent shall inform the applicable BridgeBio Entity as promptly
as practicable but in no event later than within the time frames agreed in the
Quality Agreement of notification of any action by, or notification or other
information which it receives (directly or indirectly) from, any Regulatory
Authority with respect to a BridgeBio Product or the BWI Facility which:
(i) raises any material concerns regarding the safety or efficacy of a BridgeBio
Product; (ii) relates to expedited and periodic reports of adverse events with
respect to a BridgeBio Product; (iii) are Regulatory Warning Notices; and/or
(iv) which may have an adverse impact on Regulatory Approval, Development,
Manufacturing or Commercialization of a BridgeBio Product.

(b)Cooperation.  The Parties shall reasonably cooperate with and assist each
other in complying with regulatory obligations, including by each Party
providing to the Parties such information and documentation which is in such
Party’s possession as may be reasonably necessary for a Party to prepare a
response to an inquiry from a Regulatory Authority with respect to BridgeBio
Products or the BWI Facility under the Dedicated Clean Room Collaboration.

(c)Disclosures. In addition to its obligations under this Agreement, Catalent
shall promptly disclose to the applicable BridgeBio Entities the following
regulatory information: all material notices or demands received from Regulatory
Authorities in connection with a BridgeBio Product or the BWI Facility under the
Dedicated Clean Room Collaboration, including any notice, audit notice, notice
of initiation by Regulatory Authorities of investigations, inspections,
detentions, seizures or injunctions, a notice of violation letter (i.e., an
untitled letter), warning letter, service of process or other inquiry, including
that which may affect the overall compliance status of any party participating
in the Manufacturing of a BridgeBio Product under the Dedicated Clean Room
Collaboration.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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5.6Environmental Audit of BWI Facility.

Catalent agrees that BridgeBio (the “Auditing Party”) shall have the right upon
reasonable notice and during normal business hours, at the Auditing Party’s
expense, once every year during the Term of this Agreement to conduct, or to
nominate a Third Party (subject to the execution of confidentiality and
indemnity agreements reasonably acceptable to Catalent and the Auditing Party)
to conduct on the Auditing Party’s behalf, an environmental audit of Catalent’s
operations at the BWI Facility under this Agreement to monitor Catalent’s
compliance with applicable environmental Laws and Regulatory Acts, and with
applicable environmental health safety guidelines; provided, however, the
Auditing Party or any such Third Party may not perform any invasive testing of
the BWI Facility without Catalent’s prior written consent, which shall not be
unreasonably withheld, conditioned or delayed, and the Auditing Party or any
such Third Party will provide Catalent the opportunity to accompany Auditing
Party or any such Third Party in the event of any such invasive testing of the
BWI Facility.  

Article VI
Limitations and Certain Rights

6.1Limitations.

(a)No Unauthorized Use.  Each Party covenants that it will not use or practice
any Patents, Know-How or Confidential Information licensed, sublicensed,
disclosed or otherwise made available to it under the Definitive Agreements
except for the purposes expressly permitted in an applicable license grant to
such Party that is explicitly set forth in the Definitive Agreements.  Except as
explicitly set forth in the Definitive Agreements, no Party grants any license,
express or implied, under any Patents, Know-How, Regulatory Materials,
Confidential Information or any other intellectual property rights, whether by
implication, estoppel or otherwise.

(b)Limited Access.  Catalent hereby covenants to and agrees with BridgeBio that
it and its Affiliates shall limit access to the materials, processes, methods
and Confidential Information utilized in the Manufacturing of BridgeBio Products
to such employees of Catalent or its Affiliates on a need to know/access basis,
where each such employees are bound by confidentiality and intellectual property
provisions at least as protective of BridgeBio Entities or Strategic Partners as
those set forth in this Agreement.

6.2Continuity of Operations.

(a)Through the Term, Catalent shall keep up to date a clearly organized, written
record of all standard operating procedures and other Know-How utilized by or on
behalf of Catalent to fulfill its obligations and perform under the Definitive
Agreements, including: (i) as it relates to the operation and maintenance of the
BWI Facility in connection with Manufacturing BridgeBio Products under the
Dedicated Clean Room Collaboration; and (ii) the utilization (or not) of any
BridgeBio Technology (including, for example, the Know-How of any Third-Party
(such as a redundant contract development and manufacturing organization)) made
available to Catalent by or on behalf of BridgeBio.  

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been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(b)For the sole purpose of the Dedicated Clean Room Collaboration, Catalent
hereby grants to the BridgeBio Entities a non-exclusive, fully paid up,
perpetual, irrevocable right and license to use for the Licensed Purpose (i)
standard operating procedures, other Know-How and Confidential Information of
Catalent, as well as (ii) the Regulatory Materials and Regulatory Approvals
(together with a right of reference in all such approvals and materials) in the
name of, owned by or otherwise held by or behalf of Catalent or its Affiliates
relating to the BWI Facility’s establishment license and other licenses for the
maintenance and operation of the BWI Facility (the “Licensed Subject Matter”). 
The BridgeBio Entities agree not to use such license for any purpose other than
verifying the completeness of the licensed subject matter, unless and until this
Agreement is terminated due to material breach by Catalent under any Definitive
Agreement or bankruptcy of Catalent in which case the BridgeBio Entities may use
such license for the purposes of Development, Manufacture, and Commercializing
of a BridgeBio Product that was the subject of a BridgeBio Manufacturing and
Supply Agreement or an Additional Supply Agreement.

Article VII
Force Majeure

7.1Force Majeure Events.  No Party shall be in default under this Agreement
because of any failure to perform if the failure arises from causes beyond the
control and without the fault or negligence of such Party (“Force Majeure
Event”), unless:

(a)The supplies, services or other subject matter impacted by the Force Majeure
Event were obtainable from other sources; and

(b)The Party experiencing a Force Majeure Event preventing it from performing
its obligations or duties under this Agreement failed to obtain such supplies,
services or other subject matter therefrom.

7.2Examples.  Examples of these Force Majeure Events are: (1) acts of God or of
the public enemy, (2) acts of any Governmental Authority in either its sovereign
or contractual capacity, (3) fires, (4) floods, (5) epidemics, (6) quarantine
restrictions, (7) strikes (exclusive of labor disputes), (8) freight embargoes,
and (9) unusually severe weather.  A Force Majeure Event does not include (i) a
party’s financial inability to perform, or general business or economic
conditions affecting the industry as a whole, or (ii) an act, omission or
circumstance arising from the negligence or willful misconduct of the party
claiming that a Force Majeure event has occurred.

7.3Process.

(a)The Party experiencing a Force Majeure Event preventing it from performing
its obligations or duties under this Agreement shall promptly notify the other
Party of the occurrence and particulars of such Force Majeure Event and shall
provide the other Party, from time to time, with its best estimate of the
duration of such Force Majeure Event and with notice of the resolution or
cessation thereof.  The Party so affected shall use commercially reasonable
efforts to avoid or promptly remove such causes of nonperformance.  

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(b)Upon resolution or cessation of the Force Majeure Event, the affected Party
shall promptly notify the other Party thereof, and performance of any suspended
obligation or duty under this Agreement shall promptly recommence.

(c)This Article VII will not operate to excuse payment by either Party of any
amounts due to another Party under this Agreement

Article VIII
Confidentiality

8.1Sharing of Confidential Information.  The BridgeBio Entities may from time to
time share and exchange Confidential Information with Catalent and Catalent may
share Confidential Information from any one of the BridgeBio Entities with any
of the other BridgeBio Entities and/or BridgeBio Pharma, Inc. (the parent entity
of BridgeBio).  

8.2Confidential Disclosure Agreement.  Catalent and each of ASPA and Adrenas
entered into GMP Manufacturing Services Agreements (each a “GMP Agreement”) with
an effective date of [***].  The confidentiality obligations set forth in the
GMP Agreements remain in full force and effect and, in the event of a conflict
between the confidentiality obligations provided in the GMP Agreements and this
Agreement, the terms in this Agreement will control solely with respect to the
Dedicated Clean Room Collaboration.

8.3Confidential Information.  As used in this Agreement and the other Definitive
Agreements, the term “Confidential Information” means the following:

(a)all information furnished by or on behalf of a disclosing party, its
Affiliates or any of its or their respective Representatives (the “Disclosing
Party”), to the other Party, its Affiliates or any of its or their respective
Representatives (the “Receiving Party”), whether furnished before, on or after
the Effective Date and furnished in any form, including written, verbal, visual,
electronic or in any other media or manner and information acquired by
observation or otherwise during any site visit at the other Party’s
facility.  Confidential Information includes all proprietary technologies,
know-how, trade secrets, discoveries, inventions and any other intellectual
property (whether or not patented), analyses, compilations, business or
technical information and other materials prepared by either Party, their
respective Affiliates, or any of its or their respective Representatives,
containing or based in whole or in part on any information furnished by the
Disclosing Party, its Affiliates or any of its or their respective
Representatives; and

(b)any information concerning this Agreement or the other Definitive Agreements;
and

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(c)includes but is not limited to that which relates to business plans,
strategic plans or business methods that derive economic value from not being
generally known to other persons or easily ascertainable by other persons,
business policies, research, product plans, BridgeBio Products or components
thereof, product pricing or product strategy, services, service pricing or
service strategy, manufacturing information, actual or proposed alliance
partners, actual or proposed vendors, vendor offerings and pricing, actual or
proposed customers, customer usage and customer purchasing potential, employee
and consulting relationship information, actual or proposed markets, sales and
marketing materials, plans and methods, specifications, shop-practices,
software, developments, inventions (whether or not patented), product names or
marks, trade secrets, technologies, discoveries, and any other intellectual
property (whether or not registered), processes, designs, drawings, engineering,
hardware configuration information or finance, accounting or financial plans and
forecasts, compilations, formulas, devices, methods, prototypes, techniques,
procedures, protocols, programs, records, and databases.

8.4Exceptions to Confidential Information.  Confidential Information shall not
include any information or materials to the extent the Receiving Party can
reasonably demonstrate through its contemporaneous written records that such
information or materials are or have been:

(a)part of public domain at the time of its creation or receipt by the Receiving
Party or which thereafter becomes part of the public domain other than as a
result of a breach of this Agreement or the obligations of confidentiality under
this Agreement; or

(b)is approved in writing by the Disclosing Party for release; or

(c)independently developed by the Receiving Party or its Affiliates or
Representatives without use of or reference to the Confidential Information of
the Disclosing Party; or

(d)received from a Third Party who, to the knowledge of the Receiving Party, is
not under any obligation of confidentiality towards the Disclosing Party with
respect to such information.

The Receiving Party has the burden of proving any of the above exceptions.  The
Disclosing Party has the right to inspect the Receiving Party’s documentary
evidence upon which the Receiving Party bases its claim that Confidential
Information is within any of the above exceptions.  

8.5Confidentiality Obligations.  Each Party shall keep all Confidential
Information received from or on behalf of another Party with the same degree of
care with which it maintains the confidentiality of its own Confidential
Information, but in all cases no less than a reasonable degree of care.  Each
Party, in their position as a Receiving Party hereunder, shall, during the Term
and for [***] thereafter:

(a)not use the Disclosing Party’s Confidential Information other than as
strictly necessary to exercise its rights and perform its obligations under this
Agreement; and

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(b)maintain the Disclosing Party’s Confidential Information in strict confidence
and, subject to Section 8.6, not disclose the Disclosing Party’s Confidential
Information to any Person without the Disclosing Party’s prior written consent,
provided, however, the Receiving Party may disclose the Confidential Information
to its Representatives who:

(i)have a need to know the Confidential Information for purposes of the
Receiving Party’s performance, or exercise of its rights concerning the
Confidential Information, under this Agreement, it being understood that, except
as provided for in Section 8.6, in no event shall Catalent share any
Confidential Information of BridgeBio with other customers of Catalent
(excluding BridgeBio Entities) or use such information for the benefit of other
customers of Catalent (excluding BridgeBio Entities);

(ii)have been apprised of this restriction; and

(iii)are themselves bound by written nondisclosure agreements or ethical
obligations of confidentiality at least as restrictive as those set forth in
this Section 8.5, provided further that the Receiving Party shall be responsible
for ensuring its Representatives’ compliance with, and shall be liable for any
breach by its Representatives of the confidentiality and non-disclosure
obligations set forth herein.

8.6Permitted Disclosure and Use.  Notwithstanding Section 8.5, a Party may
disclose Confidential Information belonging to another Party if and only to the
extent such disclosure is reasonably necessary to:  

(a)comply with applicable Laws, Regulatory Acts, rules, regulations, government
requirements or court orders, provided that the Receiving Party shall promptly
notify the Disclosing Party of its notice of any such requirements, and provide
the Disclosing Party a reasonable opportunity to seek a protective order or
other appropriate remedy or waive its rights under this Article VIII; and
disclose only the portion of Confidential Information that it is legally
required to furnish;

(b)secure any Regulatory Approvals for the BridgeBio Products, provided that the
Disclosing Party will take all reasonable steps to limit disclosure of the
Confidential Information outside such Regulatory Authority and to otherwise
maintain the confidentiality of the Confidential Information; or

(c)solely with respect to Confidential Information consisting of this Agreement
and, if executed, the other Definitive Agreements and the financial aspects of
such agreements, for the presentation of or reporting to (i) financial agencies
or institutions, (ii) actual or potential investors or brokers, or (iii)
potential Third Party acquirors (including their respective officers, directors,
employees and representatives) of all or substantially all of the relevant
Party’s assets or lines of business; and maintaining compliance with the
Definitive Agreements executed in connection with this Section 8.6(c)(i), (ii)
and (iii); provided that any such disclosure is provided pursuant to a
confidentiality agreement containing similar or more restrictive terms than in
this Agreement.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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8.7Notification.  A Receiving Party shall notify a Disclosing Party promptly
upon discovery of any unauthorized use or disclosure of a Disclosing Party’s
Confidential Information and will cooperate with a Disclosing Party in any
reasonably requested fashion to assist a Disclosing Party to regain possession
of such Confidential Information and to prevent its further unauthorized use or
disclosure.

8.8Publicity.  The Parties agree that any public announcement of the execution
of this Agreement will be in the form of a mutual press release to be agreed
upon by the Parties.  Except as otherwise provided in this Section 8.8, each
Party shall maintain the confidentiality of all provisions of this Agreement,
and without the prior written consent of the other Party, which consent shall
not be unreasonably withheld, no Party nor its respective Affiliates shall make
any press release or other public announcement of the provisions of this
Agreement to any Third Party, except for:  (i) disclosures required by stock
exchange regulation or any listing agreement with a national securities
exchange, in which case a Disclosing Party shall provide the other Parties with
at least [***] notice unless otherwise not practicable, but in any event no
later than the time a disclosure required by such stock exchange regulation or
listing agreement is made; and (ii) disclosures as may be required by applicable
Laws and Regulatory Acts, including but not limited to those required by the
Securities Exchange Commission and the FDA, in which case a Disclosing Party
shall provide the other Parties with prompt advance notice of such disclosure
and cooperate with the other Party to seek a protective order or other
appropriate remedy, including a request for confidential treatment in the case
of a filing with the Securities and Exchange Commission.  A Party may publicly
disclose without regard to the preceding requirements of this Section 8.8 any
information that was previously publicly disclosed pursuant to this Section 8.8.

8.9Use of Names.  Except as otherwise set forth in this Agreement, no Party
shall use the name of another Party in relation to the Dedicated Clean Room
Collaboration in any public announcement, press release or other public document
without the written consent of such other Party.

8.10Defend Trade Secrets Act Notice.  The Receiving Party acknowledges, and
shall inform its Representatives of, the following notice required by the Defend
Trade Secrets Act: An individual will not be held criminally or civilly liable
under any federal or state trade secret law for the disclosure of a trade secret
that is made in confidence to a federal, state, or local government official or
to an attorney solely for the purpose of reporting or investigating a suspected
violation of law.  Similarly, an individual will not be held criminally or
civilly liable under any federal or state trade secret law for the disclosure of
a trade secret that is made in a complaint or other document filed in a lawsuit
or other proceeding, if such filing is made under seal.  An individual who files
a lawsuit for retaliation by an employer for reporting a suspected violation of
law may disclose the trade secret to that individual’s attorney and use the
trade secret information in the court proceeding, if the individual files any
document containing the trade secret under seal; and does not disclose the trade
secret, except pursuant to court order.

8.11Survival.  The obligations and prohibitions contained in this Article VIII
as they apply to Confidential Information shall survive the expiration or
termination of this Agreement for a [***].

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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Article IX
Financial Provisions

9.1Clean Room Reservation Fee.  BridgeBio shall pay Catalent a Clean Room
Reservation Fee of [***] for the Dedicated Clean Room Suite according to the
terms herein as follows: (i) [***] which has already been paid to Catalent
pursuant to the ISA, (ii) [***] shall be paid within [***] from the Effective
Date of this Agreement, (iii) [***] shall be paid within [***] following the
date of the [***], and (iv) [***] shall be paid within [***] following the date
of the [***].

9.2Clean Room Use Fee.  

(a)As set forth in Article III, upon the start of the first BMP following the
Readiness Determination and during the Dedicated Clean Room Period (defined
below), BridgeBio shall pay to Catalent an annual Clean Room Use Fee equal to
[***], payable in advance with [***] payable prior to the [***] and [***]
payable prior to the [***], and prorated for the first year and the last year
based on the date of the Readiness Determination.  If an extension to the
Dedicated Clean Room Period is exercised by BridgeBio, the Clean Room Use Fee
shall be subject to reasonable adjustments by Catalent during the Extended
Dedicated Clean Room Period.  Payments of the Clean Room Use Fee shall be made
within [***] upon receipt of an invoice from Catalent (the “Clean Room Use Fee
Invoice”).  

(b)If the Dedicated Clean Room Suite is not being fully utilized for the
Manufacture of BridgeBio Products based on the BridgeBio Entities’ binding
forecasts of its supply needs during a Dedicated Manufacturing Period, Catalent
may use the Dedicated Clean Room Suite or rooms within the Dedicated Clean Room
Suite for Manufacturing on behalf of other Catalent customers by providing
notice to BridgeBio at least [***] prior to the date of its intended use (a
“Catalent Use Request”) and such Catalent Use Notice shall describe the schedule
during which the room will be used and the nature of the Manufacturing
activities that will be performed, subject to any confidentiality requirements
between Catalent and its customers.  As provided for in Exhibit B, Catalent
shall provide a credit to BridgeBio against the Clean Room Use Fee on a
proportional basis for each month of use of the suite or the clean rooms therein
by Catalent for other Catalent customers (the “Catalent Use Credit”).  

9.3BridgeBio-Requested Equipment.  If BridgeBio has equipment needs beyond the
Base Equipment Package that have been discussed and approved by the JSC or
otherwise authorized in a writing duly executed by an officer of BridgeBio,
Catalent will procure such equipment in consultation with BridgeBio (the
“BridgeBio-Requested Equipment”) and BridgeBio will pay (i) the actual
procurement cost of the BridgeBio-Requested Equipment (the “BridgeBio-Requested
Equipment Cost”), (ii) as approved by the JSC, a reimbursement to Catalent of up
to [***] of the BridgeBio-Requested Equipment Cost for Catalent’s internal and
external costs for installing, commissioning, qualifying, and validating the
BridgeBio-Requested Equipment, and (iii) an annual equipment use fee to cover
the maintenance, metrology/calibration, storage, and any other costs associated
with the BridgeBio-Requested Equipment (the “BridgeBio-Requested Equipment Use
Fee”).  Upon receipt of an invoice from Catalent for the procurement

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been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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of the BridgeBio-Requested Equipment Cost, along with supporting documentation
from the equipment vendor, BridgeBio shall pay to Catalent the invoiced amount
within [***] of receipt.  [***] shall own all right, title, and interest in and
to any and all such BridgeBio-Requested Equipment and such equipment shall be
used in the performance of Development and Manufacturing services solely for
[***] unless otherwise mutually agreed by the Parties.  [***] shall be
responsible for the use, maintenance, repair and storage of the
BridgeBio-Requested Equipment; [***] shall be responsible for the cost of the
maintenance, and repair of the BridgeBio-Requested Equipment which shall be
included in the BridgeBio-Requested Equipment Use Fee.  BridgeBio shall be
consulted for all non-routine maintenance and repairs involving
BridgeBio-Requested Equipment.  In addition to the BridgeBio-Requested Equipment
Cost and at BridgeBio’s cost, Catalent will procure and maintain spare parts and
equipment necessary to ensure the BridgeBio-Requested Equipment is fully
operational during the Term of the Agreement.  Furthermore, Catalent shall
maintain the BridgeBio-Requested Equipment in a validated state during the Term
of this Agreement.  If at any time during a calendar year, Catalent uses the
BridgeBio-Requested Equipment for other Catalent customers, Catalent shall
[***]. However, notwithstanding the foregoing, any costs for non-routine
maintenance or repairs which are the result of Catalent’s use of such equipment
for other Catalent customers shall not be charged to BridgeBio.  Disposition of
BridgeBio-Requested Equipment upon expiration or termination of this Agreement
shall be pursuant to Section 12.2.  [***] may request to purchase from [***] any
BridgeBio-Requested Equipment and terms of sale will be as mutually agreed to in
writing by the Parties.

9.4Withholding Tax Matters.  Only if applicable during the Term, a Party making
a payment to another Party under the Dedicated Clean Room Collaboration will
have the right to withhold taxes in the event that authorities in any country
requires tax withholding on amounts paid hereunder to such other Party.  Any
such withheld taxes shall be paid by such paying Party to the proper taxing
authority on behalf of such other Party.  The paying Party will secure and send
to such other Party proof evidencing payment of such taxes withheld and paid by
the paying Party for the benefit of such other Party.  The paying Party will,
upon request of the other Party, assist that Party in claiming exemption from
(or reduction in the amount of) such deductions or withholdings under any
applicable income tax treaty by providing such documentation as may be
reasonably required by such other Party to claim such exemption.

9.5Audit.  During the Term of this Agreement and for a period of [***] after its
termination, expiration or cancellation, but no more than once each [***] and
only once within the [***] period after termination, expiration or cancellation,
BridgeBio shall, upon [***] prior written notice, have the right to have an
independent Third Party auditor, mutually acceptable to both Parties, examine
the relevant books and records of Catalent for the previous [***] to confirm the
costs related to (i) Procurement Costs, (ii) BridgeBio-Requested Equipment,
(iii) the BridgeBio-Requested Equipment Use Fees, and (iv) CRUF Credits were
made in accordance with and consistent with the requirements of this
Agreement.  Any such auditor shall be subject to confidentiality obligations no
less stringent than those contained in this Agreement, and Catalent shall not be
obligated to disclose its Confidential Information to the auditor except to the
extent such disclosure is necessary to verify the accuracy of costs described
above.  The audits shall be

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been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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conducted during reasonable business hours and a copy of any such audit report
shall be provided to Catalent at the same time it is provided to BridgeBio.  The
cost of all audits conducted pursuant to this Section 9.4 shall be borne [***]
unless the auditors find an overcharge by Catalent for such fees in an amount
equal to the greater of (x) [***] and (y) [***] charged by Catalent for such
items, in which case [***] of the audit shall be borne [***].

Article X
Intellectual Property

10.1General. As part of the Dedicated Clean Room Collaboration, this Article X
provides the general terms regarding Intellectual Property and attendant rights
of the Parties thereto.  The BridgeBio Manufacturing and Supply Agreement will
also have terms and conditions pertaining to the parties’ rights and
responsibilities as to Intellectual Property.  In the event of a conflict
between the terms and conditions in this Agreement as to Intellectual Property
associated with a BridgeBio Product and the terms and conditions in the
BridgeBio Manufacturing and Supply Agreement, the conflicting terms and
conditions in the applicable BridgeBio Manufacturing and Supply Agreement shall
control.  In the event of a conflict between the terms and conditions in this
Agreement as to Intellectual Property associated with the Dedicated Clean Room
Suite and the terms and conditions in the BridgeBio Manufacturing and Supply
Agreement, the conflicting terms and conditions in this Agreement shall control.

10.2License to Catalent.  BridgeBio retains all right, title, and interest in
and to any BridgeBio Intellectual Property.  During the Term, BridgeBio hereby
grants to Catalent a fully paid, non-exclusive license under any and all
BridgeBio Intellectual Property and BridgeBio Arising IP that is necessary for
the sole and limited purpose of Catalent’s performance of its obligations under
this Agreement (limited to BridgeBio Products), including, without limitation,
the Dedicated Clean Room Collaboration.

10.3License to BridgeBio.  Except as expressly set forth herein, Catalent
retains all right, title, and interest in and to any Catalent Intellectual
Property.  Any Intellectual Property arising under the Dedicated Clean Room
Collaboration that relates generally to the Development or Manufacture of
substances or drug products, including any process, protocol, technology,
Know-How or the like that applies generally to the conduct by Catalent of
laboratory and manufacturing operations and activities, except to the extent any
of the same constitutes BridgeBio Intellectual Property or BridgeBio Arising IP,
or incorporates or utilizes BridgeBio Confidential Information, BridgeBio
Arising IP, BridgeBio Intellectual Property, BridgeBio’s proprietary materials,
or are directly related to the BridgeBio Product and/or directly related to
those aspects of the Manufacturing Process that are specific to the BridgeBio
Product, shall be “Catalent Arising IP,” and Catalent shall own all right, title
and interest therein.  Catalent hereby grants to BridgeBio [***]  

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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10.4Project Intellectual Property.  All Intellectual Property created or
developed by (i) BridgeBio or (ii) solely or jointly by or on behalf of Catalent
in the course of participating in the Dedicated Clean Room Collaboration that
incorporates or utilizes BridgeBio Confidential Information, BridgeBio’s
proprietary materials, or BridgeBio Intellectual Property or are directly
related to a BridgeBio Product and/or directly related to those aspects of the
Manufacturing Process that are specific to a BridgeBio Product or are an express
deliverable to BridgeBio, shall be “BridgeBio Arising IP” and the exclusive
property of BridgeBio. As such BridgeBio Arising IP is created or developed,
Catalent shall provide written notice to BridgeBio of any such BridgeBio Arising
IP and is recognized as such by Catalent, as soon as possible but no later than
[***] after conception or observation of the same by Catalent. Catalent hereby
assigns to BridgeBio all right, title, and interest in and to all such BridgeBio
Arising IP, free and clear of all liens, claims, and encumbrances, and shall
take any actions, including but not limited to the execution of documents,
reasonably requested by BridgeBio and at BridgeBio’s expense, to effect the
purposes of the foregoing. Notwithstanding the foregoing, for clarity, to the
extent Intellectual Property is created or developed under another Definitive
Agreement, the terms and conditions of such Definitive Agreement shall control.

10.5Patent Filings; Cooperation.  The Parties agree to reasonably cooperate in
the preparation, filing, prosecution and maintenance of all Patents disclosing
or claiming the BridgeBio Arising IP or the Catalent Arising IP (collectively,
the “Arising IP Patents”), including obtaining and executing necessary powers of
attorney and assignments by the named inventors, providing relevant technical
reports to the filing Party concerning Inventions disclosed in such Arising IP
Patents, obtaining execution of such other documents which are needed in the
filing and prosecution of such Arising IP Patents.  The Parties shall cooperate
reasonably in the prosecution of all Arising IP Patents.

Article XI
Representations and Warranties

11.1BridgeBio and Catalent Mutual Representations and Warranties.  BridgeBio and
Catalent each hereby represent, warrant and covenant to one another as follows,
as of the Effective Date:

(a)Corporate/Company Existence and Power.  It is a company or corporation duly
organized, validly existing, and in good standing under the Laws of the
jurisdiction in which it is incorporated, and has full company or corporate
power and authority and the legal right to own and operate its property and
assets and to carry on its business as it is now being conducted and as
contemplated in this Agreement, including the right to grant the licenses
granted by it hereunder (except as provided in Section 11.1(d)).

(b)Authority and Binding Agreement.  

(i)It has the company or corporate power and authority and the legal right to
enter into this Agreement and perform its obligations hereunder,

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been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(ii)It has taken all necessary company or corporate action on its part required
to authorize the execution and delivery of this Agreement and the performance of
its obligations hereunder, and

(iii)This Agreement has been duly executed and delivered on behalf of such
Party, and constitutes a legal, valid, and binding obligation of such Party that
is enforceable against it in accordance with its terms, except as enforcement
may be affected by bankruptcy, insolvency or other similar Laws and by general
principles of equity.

(c)No Conflicts.  The execution, delivery and performance of this Agreement by
it does not (i) conflict with any agreement, instrument or understanding, oral
or written, to which it is a party and by which it may be bound or (ii) violate
any Laws of any Governmental Authority having jurisdiction over it.

(d)All Consents and Approvals Obtained.  Except with respect to Regulatory
Approvals for the Development, Manufacturing or Commercialization of a BridgeBio
Product, (i) all necessary consents, approvals and authorizations of, and
(ii) all notices to, and filings by such Party with, all Governmental
Authorities and other Persons required to be obtained or provided by such Party
as of the Effective Date in connection with the execution, delivery and
performance of this Agreement have been obtained and provided, except for those
approvals, if any, not required at the time of execution of this Agreement.

(e)Compliance with Law.  The Parties shall perform all of their respective
obligations under this Agreement in full compliance with all applicable Laws.

(f)Banned Transactions or Dealings.  No transactions or dealings under this
Agreement shall be conducted with or for a Person that is designated as the
target of any sanctions, restrictions or embargoes administered by the United
Nations, European Union, United Kingdom or the United States of America.  

11.2Mutual Covenants; No Debarment.  No Party shall use in any capacity, in
connection with the Dedicated Clean Room Collaboration or its Development,
Manufacture or Commercialization of a BridgeBio Product hereunder, any Person
who has been debarred pursuant to Section 306 of the FD&C Act (or similar Law
outside of the U.S.), who is the subject of a conviction described in such
section, and each Party shall inform the other Party in writing immediately if
it or any Person who is performing services for such Party hereunder is debarred
or is the subject of a conviction described in Section 306 (or similar Law
outside of the U.S.), or if any action, suit, claim, investigation or legal
administrative proceeding is pending or, to such Party’s knowledge, is
threatened, relating to the debarment of such Party or any Person used in any
capacity by such Party.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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11.3Additional Representations, Warranties and Covenants by Catalent.  Catalent
represents, warrants and covenants to BridgeBio as follows:

(a)As of the Effective Date, to the best of Catalent’s knowledge, the use of
Catalent Technology in the performance of activities contemplated for the
Dedicated Clean Room Collaboration as of the Effective Date shall not infringe
any Intellectual Property of Third Parties.  Catalent covenants to BridgeBio
that it shall promptly notify the applicable BridgeBio Entities in writing
should it become aware of any claims asserting such infringement, which could
reasonably be expected to affect a BridgeBio Entity’s ability to perform under
the Definitive Agreements.

(b)(i) As of the Effective Date, there is no claim, action, suit, proceeding or
governmental investigation (“Action”) of any nature filed, made, taken or
threatened against or by Catalent; and (ii) to the best of Catalent’s knowledge
as of the Effective Date, after reasonable inquiry and investigation,  no event
has occurred or circumstances exist that may give rise to, or serve as a basis
for, any such Action which could reasonably be expected to affect Catalent’s or
a BridgeBio Entity’s ability to perform the Definitive Agreements.

(c)Catalent, to the best of its knowledge, has complied, is now complying, and
will comply, with all applicable Law and Regulatory Acts relative to its use and
improvement of the BWI Facility that could adversely affect its ability to
Manufacture BridgeBio Products and all terms of the BWI Lease. The BWI Lease
means that specific lease agreement entered into by and between Harmons Road
Associates, LLC (“Landlord”) and Paragon, dated December 20, 2017.  Catalent
will notify BridgeBio of any material breach or alleged breach of the BWI Lease
by Catalent or Landlord that could adversely affect its ability to Manufacture
BridgeBio Products.  

(d)Catalent has obtained, or will obtain prior to Manufacturing the first
BridgeBio Product in the Dedicated Clean Room Suite, and will maintain during
the Term of this Agreement any required licenses, permits and authorizations
necessary to perform the Manufacturing at the BWI Facility for each BridgeBio
Entity pursuant to a BridgeBio Manufacturing and Supply Agreement.  

(e)To Catalent’s knowledge, no legal or regulatory requirement imposed on
Catalent by a Regulatory Authority will prevent Catalent from performing its
obligations under this Agreement, or otherwise complying with its obligations
under this Agreement.

[***]

11.4Additional Representations, Warranties and Covenants of
BridgeBio.  BridgeBio hereby represents, warrants and covenants to Catalent
that, as of the Effective Date, that to the best of BridgeBio’s knowledge, the
use of BridgeBio Technology in the performance of activities contemplated for
the Dedicated Clean Room Collaboration as of the Effective Date shall not
infringe any Intellectual Property of Third Parties.

 

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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11.5No Other Representations or Warranties.  EXCEPT AS EXPRESSLY STATED IN THIS
Article XI OR ANY OF THE DEFINITIVE AGREEMENTS, NO REPRESENTATIONS OR WARRANTIES
WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED REPRESENTATION OR
WARRANTY WITH RESPECT TO (I) MERCHANTABILITY, NON-INFRINGEMENT, SUITABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE, (II) THE LIKELIHOOD OF SUCCESS OF ANY
APPLICATION FOR MARKETING AUTHORIZATION RELATING TO ANY BRIDGEBIO PRODUCT
CURRENTLY IN DEVELOPMENT OR FOR WHICH MARKETING AUTHORIZATION HAS NOT YET BEEN
GRANTED EITHER IN THE U.S. OR IN ANY OTHER COUNTRY, OR (III) THE PROBABLE
SUCCESS OR PROFITABILITY OF ANY BRIDGEBIO PRODUCT AFTER THE EFFECTIVE DATE ARE
MADE OR GIVEN BY OR ON BEHALF OF A PARTY AND, EXCEPT AS EXPRESSLY STATED IN THIS
AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF
LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

11.6Catalent Indemnity.  Catalent shall defend, indemnify and hold harmless
BridgeBio and its Affiliates (each, a “BridgeBio Indemnitee”) from and against
any and all liabilities, losses, costs and expenses (collectively, “Loss”)
suffered or incurred by them in connection with any claim brought by a Third
Party that arises or is alleged to arise from or in connection with:

(a)Any material breach of representation or warranty or covenant made by
Catalent under this Agreement or any material breach of Catalent’s obligations
under this Agreement;

(b)Catalent’s use of the Dedicated Clean Room Suite for other Catalent
customers;

(c)any gross negligence or willful misconduct of Catalent, its Affiliates or any
of their respective Representatives with respect to the performance of this
Agreement; and

(d)infringement of any Third-Party Intellectual Property arising from the use of
the Catalent Technology pursuant to any of this Agreement;

except to the extent in each case that the Loss in question resulted from the
gross negligence or willful misconduct of, or material breach of this Agreement
by, a BridgeBio Indemnitee or any of its or their Representatives.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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11.7BridgeBio Indemnity.  BridgeBio shall defend, indemnify and hold harmless
Catalent and its respective Affiliates (each, a “Catalent Indemnitee”) from and
against any and all Loss suffered or incurred by them in connection with any
claim brought by a Third Party that arises or is alleged to arise from or in
connection with:

(a)any material breach of representation or warranty or covenant made by
BridgeBio under this Agreement or any material breach of BridgeBio’s obligations
under this Agreement;

(b)any gross negligence or willful misconduct of BridgeBio, its Affiliates or
any of their respective Representatives with respect to the performance of this
Agreement; and

(c)infringement of any Third-Party Intellectual Property arising from the use of
the BridgeBio Technology pursuant to any of this Agreement, in a manner Covered
by BridgeBio Patents;

except to the extent in each case that the Loss in question (i) resulted from
the gross negligence or willful misconduct of, or material breach of this
Agreement by, a Catalent Indemnitee or any of its or their Representatives, or
(ii) resulted from any activities for which Catalent is obligated to indemnify a
BridgeBio Indemnitee pursuant to Section 11.6.

11.8Indemnification Procedures.  The Person or Persons claiming indemnity under
this Article XI (the “Indemnified Party”) shall give written notice to the Party
from whom indemnity is being sought (the “Indemnifying Party”) promptly after
learning of such claim.  The Indemnified Party shall provide the Indemnifying
Party with reasonable assistance, at the Indemnifying Party’s expense, in
connection with the defense of the claim for which indemnity is being
sought.  The Indemnifying Party shall have the right, but not the obligation, to
assume and conduct the defense of the claim with counsel of its choice;
provided, the Indemnified Party may participate in and monitor such defense with
counsel of its own choosing at its sole expense.  The Indemnifying Party shall
not settle any claim without (a) first consulting with the Indemnified Party,
and (b) obtaining the prior written consent of the Indemnified Party, not to be
unreasonably withheld or delayed, unless the settlement involves only the
payment of money, provided that such settlement does not adversely affect the
Indemnified Party’s rights under this Agreement or impose any obligations on the
Indemnified Party in addition to those set forth herein.  The Indemnified Party
shall not settle or compromise any such claim without (x) first consulting with
the Indemnifying Party, and (y) obtaining the prior written consent of the
Indemnifying Party.  If the Indemnifying Party does not assume and conduct the
defense of the claim as provided above, (i) the Indemnified Party may, using
counsel of its choice, defend against such claim in any manner the Indemnified
Party may deem reasonably appropriate, and (ii) the Indemnifying Party shall
remain responsible to indemnify the Indemnified Party as provided in this
Article XI, provided, that in such instance such indemnity shall also include
the reasonable legal fees and reasonable Out-of-Pocket Costs incurred by the
Indemnified Party in connection with so defending itself in the absence of a
defense being provided by the Indemnifying Party.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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11.9Insurance.  Upon the Effective Date as to Catalent, and within [***] of the
Effective Date with respect to BridgeBio, through the remainder of the Term of
this Agreement, each Party, and, to the extent applicable, its approved
subcontractors, shall obtain and maintain (or have obtained and maintained on
its behalf) with insurers having A.M. Best ratings of A-VII or higher at all
times as of and after the date of this Agreement, at its own cost and expense:
(i) general liability insurance with a per occurrence limit of [***] or
equivalent and an annual aggregate limit of [***] or equivalent; and (ii)
Workers’ Compensation as required by all applicable laws and Employer’s
Liability coverage with a limit of not less than [***].  If any such policy is
replaced, each Party agrees to purchase tail coverage or ensure that the new
policy has a retroactive date that is consistent with the start of any work
under a scope of work and that such Party will continue to be covered on the
replacement policy.  Each Party may self-insure all or any portion of the
required insurance as long as, together with its Affiliates, its US GAAP net
worth is greater than [***] or equivalent, or its annual EBITDA (earnings before
interest, taxes, depreciation and amortization) is greater than [***] or
equivalent.  Waivers of subrogation and additional insured status obligations
will operate the same whether insurance is carried through third parties or
self-insured.  Upon the other Party’s written request from time to time, each
Party shall promptly furnish to the other Party a certificate of insurance or
other evidence of the required insurance.  Without limiting the foregoing, each
Party shall obtain and maintain Special Form (formerly known as All Risk)
insurance coverage which includes business interruption.  For the avoidance of
doubt, BridgeBio may satisfy its insurance requirements set forth in this
Section 11.9 if an Affiliate of BridgeBio obtains and maintains insurance that
covers BridgeBio as provided for herein.

Article XII
Termination and Survival

12.1Term and Termination.

(a)The term of this Agreement shall begin on the Effective Date and continue
until the earlier of (i) the latest expiration or termination of the (x) the
BridgeBio Manufacturing and Supply Agreement or (y) any Additional Manufacturing
and Supply Agreement, (ii) [***] from the Readiness Determination (the
“Dedicated Clean Room Period”), or (iii) termination in accordance with this
Section 12.1 (the period from the Effective Date to termination being the
“Term”).  Subject to the mutual agreement of the Parties, the Agreement may be
extended for an additional [***] (provided that BridgeBio provides notice of its
desire to such extension at least [***] before the end of the Dedicated Clean
Room Period) (the “Extended Dedicated Clean Room Period”).  The Parties may
otherwise extend the Term by mutual written agreement.

(b)BridgeBio shall have the right to terminate this Agreement by giving written
notice to Catalent in the event of any of the following:

(i)For convenience; or

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been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(ii)If any of the BridgeBio Products undergoes a market withdrawal, or otherwise
is determined by BridgeBio or a Regulatory Authority to have material safety,
efficacy, or Manufacturing risks which could impact the Commercialization of the
BridgeBio Product and such risks would reasonably be expected to similarly
impact all other BridgeBio Products that are the subject of a Manufacturing and
Supply Agreement, in each case leading to the cessation or termination of
Development, Manufacture, or Commercialization of, or seeking Regulatory
Approval for, the BridgeBio Product; or

(iii)If BridgeBio has, in good faith, exhausted all reasonable remedies to
resolve a patent dispute and a court or other competent authority issues a final
decision that BridgeBio Technology infringes a valid and enforceable Patent held
by a Third Party or grants an injunction that renders BridgeBio unable to sell a
BridgeBio Product.  

[***]

(c)Either Party hereto shall have the right to terminate this Agreement by
giving the other Party written notice in the event of any of the following:

(i)The bankruptcy or insolvency of the other Party; or

(ii)If the other Party is in material breach of one of the Definitive
Agreements, provided that if the breach is capable of cure (1) the non-breaching
Party shall first provide [***] prior written notice and an opportunity to cure
to the breaching Party and (2) in the event the breach is not cured within such
[***] period, the breaching Party has not diligently pursued an acceptable cure
and provided a reasonable plan of proposed actions and schedule for completing
such cure outside the [***] period that the non-breaching Party agrees, in its
sole discretion, is reasonably likely to allow for cure in a sufficient and
timely enough manner; or

(iii)The other Party is suspended or debarred by FDA or the United States
government.

12.2Effect of Termination.

(a)If this Agreement is terminated by BridgeBio pursuant to Sections 12.1(b)(i)
or (iii) or by Catalent pursuant to Section 12.112.1(c), the economic
consequences will be solely as follows (except, in the case of termination for
breach, to the extent additional remedies are available under applicable Law):
Catalent shall be entitled to the Clean Room Reservation Fee.  In addition,
Catalent shall also be paid all other amounts owed by BridgeBio under the terms
of this Agreement as of the date of termination including, but not limited to,
any outstanding or owed Clean Room Use Fees, BridgeBio-Requested Equipment
Costs, and BridgeBio-Requested Equipment Use Fees.  BridgeBio shall pay to
Catalent all of the outstanding unpaid and undisputed invoices within [***] of
the date of termination.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(b)If this Agreement is terminated by BridgeBio pursuant to Section 12.1(b)(ii),
the economic consequences will be solely as follows: Catalent shall provide to
BridgeBio a refund of a portion of the Clean Room Reservation Fee based upon the
following sliding scale: [***] of the Clean Room Reservation Fee for each full
calendar year remaining in the Dedicated Clean Room Period (e.g., if the product
fails within [***] after the Readiness Determination and BridgeBio terminates
the Agreement, Catalent will refund [***] of the Clean Room Reservation
Fee).  If the termination date is prior to the Readiness Determination (and
prior to BridgeBio’s final payment of the Clean Room Use Fee pursuant to Section
9.1), Catalent shall provide to BridgeBio a refund of [***] of the Clean Room
Reservation Fee paid as of the date of termination.  BridgeBio also shall pay to
Catalent all amounts outstanding and owed as of the date of termination
including, but not limited to, Clean Room Use Fees, BridgeBio-Requested
Equipment Costs, and BridgeBio-Requested Equipment Use Fees.  BridgeBio shall
pay to Catalent all of the outstanding unpaid and undisputed invoices within
[***] of the date of termination.

(c)If this Agreement is terminated by BridgeBio pursuant to Section 12.1(b)(iv)
or 12.1(b)(v), the economic consequences will be solely as follows: Catalent
shall provide to BridgeBio a refund of a portion of the Clean Room Reservation
Fee based upon the following sliding scale: [***] of the Clean Room Reservation
Fee for each full calendar year remaining in the Dedicated Clean Room Period.
BridgeBio shall pay to Catalent all amounts outstanding and owed as of the date
of termination including, but not limited to, Clean Room Use Fees,
BridgeBio-Requested Equipment Costs, and BridgeBio-Requested Equipment Use
Fees.  BridgeBio shall pay to Catalent all of the outstanding unpaid and
undisputed invoices within [***] of the date of termination.

(d)If this Agreement is terminated by BridgeBio at any time during the Dedicated
Clean Room Period pursuant to Sections 12.1(c), the economic consequences will
be solely as follows (except to the extent additional remedies are available
under applicable Law): Catalent shall provide BridgeBio [***].  BridgeBio shall
pay to Catalent all amounts outstanding and owed as of the date of termination
including, but not limited to, Clean Room Use Fees, BridgeBio-Requested
Equipment Costs, and BridgeBio-Requested Equipment Use Fees.  BridgeBio shall
pay to Catalent all of the outstanding unpaid and undisputed invoices within
[***] of the date of termination.

(e)Unless otherwise agreed by the Parties, a termination of this Agreement shall
result in the termination of all other Definitive Agreements.  To the extent
that BridgeBio, a BridgeBio Entity or a Strategic Partner desire to extend such
other Definitive Agreements beyond the termination of this Agreement, Catalent
agrees to negotiate in good faith the extension of such agreements; provided,
however, Catalent shall have no obligation to provide the Dedicated Clean Room
Suite for use in the Manufacture of BridgeBio Products.  For the avoidance of
doubt, following termination of this Agreement, the Parties may, but are not
obligated to, negotiate one or more separate agreements for the manufacture and
supply of BridgeBio Products.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(f)[***], catalent’s liability to bridgebio FOR ANY AND ALL INJURIES, CLAIMS,
LOSSES, EXPENSES, OR DAMAGES, WHATSOEVER, ARISING OUT OF OR IN ANY WAY RELATED
TO THE ACTIVITIES OF THIS AGREEMENT, FROM ANY CAUSE OR CAUSES INCLUDING, BUT NOT
LIMITED TO, BREACH OF CONTRACT, NEGLIGENCE, ERRORS, OMISSIONS OR STRICT
LIABILITY, SHALL NOT EXCEED THAT AMOUNT EQUIVALENT TO [***].  [***], in no event
will EITher pARTY be liable to OTHER PARTY FOR ANY INDIRECT, SPECIAL,
CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, BUT NOT LIMITED TO,
DAMAGES BASED UPON LOST PROFITS, RELIANCE OR EXPECTATION, BUSINESS INTERRUPTION,
LOST BUSINESS, OR LOST SAVINGS) FOR ANY ACTS OR FAILURE TO ACT UNDER THIS
AGREEMENT, INCLUDING ANY TERMINATION OF THIS AGREEMENT IN ACCORDANCE WITH ITS
TERMS, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBLE EXISTENCE OF SUCH
DAMAGES.  FOR CLARITY, THE PARTIES ACKNOWLEDGE AND AGREE THAT ANY AMOUNTS PAID
TO THIRD PARTIES FOR THIRD PARTY CLAIMS ARE NOT SUBJECT TO THE LIMITATION IN THE
PREVIOUS SENTENCE.  The limitations of liability reflect the allocation of risk
between the Parties.  The limitations specified in this Section 12.2 will
survive and apply even if any limited remedy specified in this Agreement is
found to have failed of its essential purpose.

(g)Upon (a) termination or during the notice period regarding termination of
this Agreement, (b) on expiry of this Agreement, or (c) at any time upon a
BridgeBio Entity’s or Strategic Partner’s written request, Catalent shall
provide reasonable assistance to the applicable BridgeBio Entity or Strategic
Partner with respect to the transfer to another manufacturer (including, the
applicable BridgeBio Entity or Strategic Partner) of the then-current
Manufacturing Process (and any Manufacturing Process Developed for such
BridgeBio Entity or Strategic Partner) for the BridgeBio Product under the
applicable Definitive Agreement.  Catalent agrees to provide copies of all
necessary and relevant documents, manufacturing instructions, batch records,
specifications and any other relevant documentation, and without limiting the
license set forth in Section 10.3, all relevant Manufacturing know-how, and
licenses under Catalent Intellectual Property and Catalent Arising IP related to
the BridgeBio Product necessary to enable the applicable BridgeBio Entity or
Strategic Partner or its designee to Manufacture BridgeBio Product in accordance
with the specifications and the applicable cGMP requirements. Pursuant to this
Section 12.2(f), the BridgeBio Entity or Strategic Partner who will receive the
above-mention documentation shall be subject to confidentiality obligations no
less stringent than those contained in this Agreement.  To the extent that such
transfer of technology involves Catalent Confidential Information, Catalent
Intellectual Property and/or Catalent Arising IP, the Third Party receiving such
information or intellectual property shall agree that its use of same is solely
for the purposes of Manufacturing the BridgeBio Products that were the subject
of the respective BridgeBio Manufacturing and Supply Agreement.  Except for a
material breach of this Agreement by Catalent, Catalent may charge to BridgeBio
and BridgeBio agrees to pay (or obligate a BridgeBio Entity or Strategic Partner
to pay) all reasonable and customary technology transfer fees and expenses for
such efforts.  [***]  In all circumstances, Catalent will use at least
commercially reasonable efforts to meet the timeline requested by the applicable
BridgeBio Entity or Strategic Partner.

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[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(h)In the event of termination or expiration of this Agreement, in addition to
any rights or obligations that by their terms are intended to survive the Term
of this Agreement, the following provisions shall survive such termination:
Article V, Article VI, Article VIII, Article X, Section 11.5, Section 11.6,
Section 11.7, Section 11.8, Section 12.2, Article XIII, and Article XIV.
Termination or expiration of this Agreement and the other Definitive Agreements
for any reason will not relieve the Parties of any liability accruing prior
thereto and will be without prejudice to the rights and remedies of any Party
with respect to any antecedent breach of the provisions of this Agreement or the
other Definitive Agreements.

(i)Each Party acknowledges that, in the event of termination and unless
otherwise agreed to by BridgeBio, Catalent shall promptly return or destroy, as
directed by BridgeBio, any master or working cell banks and BridgeBio Materials
as well as BridgeBio Technology and BridgeBio-Requested Equipment, and each
Party shall promptly return to the other Party or destroy (as such other Party
may direct) all data and documents in any form comprising or containing any
Confidential Information of the other Party, except that each Party may retain:
(a) one copy of the other Party’s Confidential Information in secure legal
archives for evidentiary purposes only and (b) a copy of computer records or
files containing such Confidential Information that have been created pursuant
to automatic archiving or back-up procedures that cannot reasonably be deleted
(collectively, “Retained Copies”), provided, however, that any such Retained
Copies will be kept confidential by the Receiving Party in accordance with the
terms and provisions of this Agreement for as long as the Receiving Party is in
possession of the Retained Copies.  In addition, upon request, Catalent shall
provide a written certification to BridgeBio that (i) Catalent and its
subcontractors have satisfied their confidentiality and recording obligations in
all respects and (ii) all BridgeBio Know-How and copies thereof on any media in
possession of Catalent, any of its employees or contractors have been destroyed
or returned to BridgeBio, such certification to be signed by a duly authorized
officer of Catalent.

Article XIII
Dispute Resolution

13.1Disputes.  The Parties recognize that, from time to time, disputes may arise
as to certain matters which relate to a Party’s rights and/or obligations in
connection with this Agreement.  It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to
litigation.  To accomplish this objective, the Parties agree to follow the
procedures set forth in this Article XIII to resolve any controversy or claim
arising out of, relating to or in connection with this Agreement.

13.2Dispute Resolution.  Any dispute that arises between the Parties in
connection with this Agreement shall first be presented to the senior executives
of the Parties for consideration and resolution.  If such executives cannot
reach a resolution of the dispute within a reasonable time, then such dispute
shall be resolved by binding alternative dispute resolution in accordance with
the International Institute for Conflict Prevention and Resolution’s Rules for
Administrated Arbitration. Arbitration shall be conducted in New York, New York,
in the English language.

29

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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

 

13.3Patent and Trademark Dispute Resolution.  Any dispute, controversy or claim
relating to the scope, validity, enforceability or infringement of any Patent
rights covering the Manufacture, use or sale of any product or technology or of
any trademark rights relating to any product or technology shall be submitted to
a patent office or court of competent jurisdiction in which such Patent or
trademark rights were granted or arose.

13.4Injunctive Relief.  Nothing herein may prevent a Party from seeking a
preliminary injunction or temporary restraining order, in any court of competent
jurisdiction, so as to prevent any Confidential Information from being disclosed
in violation of an applicable confidentiality agreement entered into by the
Parties or to prevent the threat of imminent harm.

Article XIV
Miscellaneous

14.1Assignment; Binding Effect.  

(a)This Agreement shall not be assignable by any Party hereto without the prior
written consent of each of the other Parties, provided, however, that BridgeBio
may assign this Agreement in whole or in part without the advance written
consent of Catalent to (i) its Affiliates or [***]  

(b)BridgeBio may assign its rights and obligations under this Agreement in part
on a Product-by-Product and Definitive Agreement-by-Definitive Agreement basis,
[***]

(c)Further, upon written request by BridgeBio, [***] 

(d)Any assignment of this Agreement not made in accordance with this Section
14.1 is prohibited hereunder and shall be null and void.

14.2Expenses.  Except as expressly specified herein, each Party shall bear its
own expenses with respect to this Agreement and the other Definitive Agreements.

30

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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

 

14.3Notices.  All notices, requests, claims, demands and other communications
hereunder shall be in writing and shall be deemed to have been duly given
(a) when received if delivered personally, (b) when transmitted by e-mail (with
confirmation of successful transmission and with a duplicate copy directed
pursuant to the methods set forth in (c) or (d) below), (c) upon receipt, if
sent by registered or certified mail (postage prepaid, return receipt requested)
and (d) the day after it is sent, if sent for next-day delivery to a domestic
address by overnight mail or courier, to the Parties at the following addresses:

 

If to BridgeBio

BridgeBio Gene Therapy, LLC

Attn: Eric David, President & CEO

421 Kipling St.

Palo Alto, CA 94301

Telephone:

Email:  emd@bridgebio.com

 

with a copy to:

 

BridgeBio Gene Therapy, LLC

Attn: Justin To, VP Operations

421 Kipling St.

Palo Alto, CA 94301

Telephone:

Email: jt@bridgebio.com

 

 

If to Catalent

Catalent Maryland, Inc.

Attn: President – Gene Therapy

801 West Baltimore Street, Suite 302

Baltimore, Maryland 21201

Telephone: 410-975-4050

Email: Peter.Buzy@catalent.com

 

with a copy to:

Catalent Pharma Solutions, LLC

14 Schoolhouse Road

Somerset, NJ  08873 USA

Attn:  General Counsel (Legal Department)

E-Mail: GenCouns@catalent.com

Facsimile:  +1 (732) 537-6491

 

Mr. Andrew L.  Strong

Pillsbury Winthrop Shaw Pittman, LLP

909 Fannin, Suite 2000

Houston, Texas 7701

Email: andrew.strong@pillsburylaw.com

provided, however, that if any Party shall have designated a different address
by notice to the others, then to the last address so designated.

31

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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14.4Severability.  If any term, provision, covenant or restriction of this
Agreement is held by a court of competent jurisdiction or other authority to be
invalid, void, unenforceable or against its regulatory policy such determination
shall not affect the enforceability of any others or of the remainder of this
Agreement; and in connection with such term, provision, covenant or restriction
of this Agreement which is held invalid, void, unenforceable or against
regulatory policy, the Parties shall negotiate in good faith with a view to the
substitution therefor of a suitable and equitable solution in order to carry
out, so far as may be valid and enforceable, the intent and purpose of such
invalid term, provision, covenant or restriction and, absent any agreement by
the Parties, such court of competent jurisdiction or other authority shall
substitute therefore such term, provision, covenant or restriction as is legal,
valid and enforceable but otherwise similar to the invalid term, provision,
covenant or restriction.

14.5Entire Agreement.  This Agreement may not be amended, supplemented or
otherwise modified except by an instrument in writing signed by the Parties
hereto.  The Definitive Agreements contain the entire agreement of the Parties
hereto with respect to the Dedicated Clean Room Collaboration, superseding all
negotiations, prior discussions and preliminary agreements made prior to the
date hereof.

14.6Waiver.  The failure of any Party to enforce any condition or part of this
Agreement at any time shall not be construed as a waiver of that condition or
part, nor shall it forfeit any rights to future enforcement thereof.  No waiver
of any provision of this Agreement will be valid unless made in writing and
signed by the Party to which such performance is due.

14.7Governing Law; Jurisdiction; Venue.  This Agreement (including any claim or
controversy arising out of or relating to this Agreement) shall be governed by
the Laws of the State of Delaware without regard to conflict of law principles
that would result in the application of any Law other than the Laws of the State
of Delaware.  The Parties hereto agree that a final judgment in any such action
shall be conclusive and, notwithstanding anything to the contrary, may be
enforced in other jurisdictions by suit on the judgment or in any other manner
provided by Law.  The United Nations Convention on Contracts for the
International Sale of Goods shall not apply to this Agreement.

14.8Headings.  The headings of the Articles, Sections, Subsections, Schedules
and Exhibits of this Agreement are inserted for convenience only and shall not
be deemed to constitute a part hereof.

14.9Counterparts.  This Agreement may be signed in any number of counterparts,
each and every one of which shall be considered one and the same agreement and
shall become effective when a counterpart hereof shall have been signed by each
of the Parties and delivered to each of the other Parties, notwithstanding
variations in format or file designation which may result from the electronic
transmission, storage and printing of copies of this Agreement from separate
computers or printers.  Facsimile signatures and signatures transmitted via PDF
shall be treated as original signatures.

32

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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

 

14.10Construction.  The language in all parts of this Agreement shall be
construed, in all cases, according to its fair meaning.  The Parties acknowledge
that each Party and its counsel have reviewed and revised this Agreement and
that any rule of construction to the effect that any ambiguities are to be
resolved against a drafting Party shall not be employed in the interpretation of
this Agreement.

14.11Interpretation.

(a)When a reference is made in this Agreement to an Article, Section, Exhibit,
Schedule, Recital or Preamble, such reference is to an Article, Section,
Exhibit, Schedule, Recital or Preamble of or to this Agreement unless otherwise
indicated.

(b)The words “hereof,” “herein,” “hereto” and “hereunder” and words of similar
import, when used in this Agreement, shall refer to this Agreement as a whole,
including the Exhibits and Schedules, and not to any particular provision of
this Agreement.

(c)The terms defined in the singular have a comparable meaning when used in the
plural, and vice versa.

(d)Words of one gender include the other gender.

(e)References to a Person are also to its successors and permitted assigns.

(f)The term “Dollars” and “$” means United States Dollars.

(g)The word “including” means “including without limitation” and the words
“include” and “includes” have corresponding meanings.

(h)References herein to an agreement, law or regulation include such agreement,
law or regulation as amended, restated, supplemented, or otherwise modified from
time to time unless otherwise specified.

14.12Relationship of the Parties.  This Agreement and the Dedicated Clean Room
Collaboration are not intended by the Parties to constitute or create a joint
venture, pooling arrangement, partnership, or formal business organization of
any kind, and the rights and obligations of the Parties shall be only those
expressly set forth herein and therein.  No Party will have any right, power or
authority, nor will they represent themselves as having any authority to assume,
create or incur any expense, liability or obligation, express or implied, on
behalf of another Party, or otherwise act as an agent for another Party for any
purpose.

*  *  *  *  *  *  *  *  *  *  *

 

33

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Collaboration Agreement
to be executed by their respective duly authorized officers as of the date first
above written.

 

BridgeBio GENE THERAPY LLC

 

 

 

By:

 

/s/ Eric David

 

 

 

Name:

 

Eric David

 

 

 

Title:

 

CEO – Gene Therapy

 

Catalent MARYLAND, INC.

 

 

 

By:

 

/s/ Peter Buzy

 

 

 

Name:

 

Peter Buzy

 

 

 

Title:

 

President – Gene Therapy

 

 

 

34

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EXHIBIT A

DEFINITIONS

This Exhibit A to this Collaboration Agreement provides agreed upon definitions
applicable to the Parties for purposes of this Agreement.  All capitalized terms
used in this Agreement shall have the meanings ascribed thereto in this Exhibit
A.

1.1

Definitions.

“Affiliate(s)” means, (i) with respect to any Third Party, any other
corporation, firm, partnership or other entity that directly or indirectly
through one or more intermediaries, controls, is controlled by or is under
common control with such entity; (ii) and with respect to BridgeBio, it means
BridgeBio Pharma, Inc. and any corporation, firm, partnership or other entity
controlled by BridgeBio Pharma, Inc.; and (iii) with respect to Catalent, it
means Catalent Pharma Solutions, Inc. and any corporation, firm, partnership or
other entity controlled by Catalent Pharma Solutions, Inc. For purposes of this
definition, the term “control” means the ownership of more than fifty percent
(50%) of the securities or other ownership interests representing the equity
voting stock or general partnership or membership interest of such entity or 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.  

“BridgeBio Drug Product” means a finished dosage form that contains a BridgeBio
Product, generally, but not necessarily, in association with one or more other
ingredients.

“BridgeBio Intellectual Property” means BridgeBio Patents and BridgeBio
Technology owned or Controlled by BridgeBio prior to the Effective Date, or
otherwise arising outside the performance of this Agreement.

“BridgeBio Know-How” means any present and future Know-How, including any and
all BridgeBio Technology, owned or Controlled by BridgeBio that is necessary for
or is useful to the Development, Manufacture or Commercialization of BridgeBio
Products.  For purposes of this definition, BridgeBio shall not be deemed to
Control any Know-How that is licensed or disclosed by Catalent to BridgeBio
pursuant to this Agreement.

“BridgeBio Materials” means any or all of the master cell bank, working cell
bank and/or research cell bank vials, the Cell Line, and the DNA plasmids, as
provided by or made available to Catalent by or on behalf of BridgeBio or its
predecessor in interest, or as Developed by Catalent for purposes of
Manufacturing BridgeBio Products, as the same may be amplified, processed, or
improved by Catalent in accordance with this Agreement, as well as all
information provided by or on behalf of BridgeBio concurrently therewith that
specifically relates thereto.

“BridgeBio Patents” means any Patent that is owned or Controlled by BridgeBio as
of the Effective Date or comes under the ownership or Control of BridgeBio
during the Term and Covers the Development, Manufacture, use or
Commercialization of BridgeBio Products.  For purposes of this definition,
BridgeBio shall not be deemed to Control any Patent that is licensed by Catalent
to BridgeBio pursuant to this Agreement.

A-1

 

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“BridgeBio-Requested Equipment” means the equipment requested by BridgeBio for
the Manufacture of the BridgeBio Products as set forth in Section 9.3 that is in
addition to the Base Equipment Package.

“BridgeBio Technology” means the Technology of BridgeBio developed or obtained
by or on behalf of BridgeBio or a BridgeBio Entity related to one or more
BridgeBio Products, or the Manufacture of any of the foregoing prior to the
Effective Date or arising outside the performance of this Agreement.  BridgeBio
Technology specifically includes any BridgeBio Know-How and BridgeBio Materials.

“Base Equipment Package” means the standard equipment package to be used in the
Manufacture of BridgeBio Products in a single clean room suite. Subject to final
approval by the JSC, the equipment comprising the Base Equipment Package is
listed in and attached hereto as Exhibit D.

“Batch” is defined as a specific quantity of bulk drug substance that is
intended to have uniform character and quality within specified limits and is
produced according to a single cycle of manufacture (one or more upstream
production runs, pooled if applicable, followed by a single downstream
production run).

“BLA” means a Biologics License Application (or successor or equivalent
application) (including all supplements, amendments, and modifications thereof)
for authorization for marketing of a biologic product, as defined in the
applicable Laws and regulations and filed with applicable Regulatory
Authorities.

“Bulk Drug Substance” means the active pharmaceutical ingredients in bulk form
of the BridgeBio Drug Product being Manufactured by Catalent.

“Business Day” means a day other than a Saturday, Sunday, or other day on which
commercial banks in New York are authorized or required by Law to be closed for
business.

“BWI Facility” shall mean the clinical and commercial scale biomanufacturing
facility located at 7555 Harmans Road, Baltimore, Maryland.

“Catalent Intellectual Property” means any Intellectual Property owned or
Controlled by Catalent prior to the Effective Date, or otherwise arising outside
the performance of this Agreement, without use of, reliance on, or reference to
any BridgeBio Confidential Information.

“Catalent Technology” means Technology of Catalent developed or obtained by or
on behalf of Catalent related generally to the Development or Manufacture of any
of the foregoing, prior to the Effective Date or arising outside the performance
of this Agreement.  Catalent Technology specifically includes any Catalent
Know-How, processes, procedures and controls for the Development and Manufacture
of drug substances and products.

A-2

 

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“Clean Room Reservation Fee” means a one-time fee of [***] to reserve the
Dedicated Clean Room Suite for [***] (i.e., [***]) during the Term of this
Agreement. Catalent’s use of the Clean Room Reservation Fee will be for the
buildout, commissioning, qualification, validation, equipping and exclusive use
of the clean room suite.  The Clean Room Reservation Fee will be payable
pursuant to the terms set forth on Section 9.1 of this Agreement.

“Commercialize,” “Commercializing” or “Commercialization” means all activities
directed to the marketing (whether through direct, in-person, electronic or
other marketing channels), promotion, selling or offering for sale of a product
for an indication, including planning, market research, pre-marketing activities
undertaken in preparation for launch, advertising, educating, marketing,
promoting, importing, exporting, distributing and post-marketing safety
surveillance and reporting.  For clarity, “Commercialize,” “Commercializing” or
“Commercialization” shall not include any activities included within the
Manufacturing or Development of a product.

“Construction Turnover” means the date when construction on the Dedicated Clean
Room Suite is substantially complete as set forth on Schedule 2.2, and the
Dedicated Clean Room Suite has been cleaned and is ready for process equipment
installation and commissioning, qualification and validation.

“Control,” “Controls” or “Controlled” means, when used in reference to
intellectual property, other intangible property, or materials, that a Party
owns or has a license or sublicense to such intellectual property, other
intangible property or materials, and has the ability to grant a license or
sublicense or other right to use such intellectual property, other intangible
property or materials, as applicable, as provided for herein, without
(i) requiring the consent of a Third Party or (ii) violating the terms of any
agreement or other arrangement with any Third Party.

“Cover,” “Covering” or “Covered” means, with respect to a country in the
Territory, but for a license granted under a valid claim of a Patent, the use or
sale, or offer for sale in such country of the subject matter at issue would
infringe such valid claim, or in the case of a Patent that is a Patent
application, would infringe a valid claim in such Patent application if it were
to issue as a Patent.

“Dedicated Clean Room Suite” means [***] (suite and associated corridors being
approximately [***] sq. ft.) at the BWI Facility. The approximate outline of the
floor plan and location of the Dedicated Clean Room Suite within the BWI
Facility is set forth in Exhibit C attached hereto.

“Dedicated Manufacturing Period” means the [***], the beginning and end of which
will be determined by the JSC and [***], during which Catalent shall dedicate
the Dedicated Clean Room Suite for the Manufacture of BridgeBio Products.

“Delivery” and “Delivered” shall mean Catalent’s delivery of the BridgeBio
Product, packed and packaged in appropriate containers as directed by BridgeBio,
to the BridgeBio carrier at the BWI Facility.

A-3

 

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“Develop,” “Developing” or “Development” means and all activities relating to
research, non-clinical, preclinical and clinical trials, toxicology testing,
statistical analysis, publication and presentation of research and study results
and reporting, process and analytical development, analytical testing,
preparation and submission of applications (including any CMC-related
information) for regulatory approval of a product, necessary or reasonably
useful or otherwise requested or required by a Regulatory Authority as a
condition or in support of obtaining or maintaining all regulatory approvals for
such product.  For clarity, “Development” shall not include any activities
included within the Manufacturing of a product.

“EMA” means the European Medicines Agency or its successor.

“EU” means the countries of the European Union as it exists at any time.

“FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and
the regulations promulgated thereunder.

“FDA” means the U.S. Food and Drug Administration or its successor.

“Fiscal Year” means the calendar year commencing on January 1 and concluding on
December 31.

“GAAP” means United States generally accepted accounting principles, as in
effect from time to time, consistently applied.

“Good Manufacturing Practices” or “cGMPs” means the then-current good
manufacturing practices required by (i) the FDA, as set forth in the FD&C Act
and the regulations promulgated thereunder, for the manufacture and testing of
pharmaceutical materials, including the provisions of 21 C.F.R. Parts 210 and
211, (ii) European Commission Directive 91/356/EEC, as amended by Directive
2003/94/EC, and 91/412/EEC respectively, as well as “The rules governing
medicinal products in the European Union,” Volume 4, Guidelines for good
manufacturing practices for medicinal products for human and veterinary use, and
(iii) the principles detailed in the ICH Q7A guidelines, in each case, including
all applicable rules, regulations, orders and guidance applicable thereto, and
as each may be amended from time to time, and any successor thereto.

“Governmental Authority” means any multinational, federal, state, local,
municipal or other governmental authority of any nature (including any
governmental division, prefecture, subdivision, department, agency, bureau,
branch, office, commission, council, court or other tribunal), in each case,
having jurisdiction over the applicable subject matter.

“Invention” means any subject matter invented during the Term by or on behalf of
a Party or one or more of the Parties jointly, as determined in accordance with
the provisions of U.S. patent Law governing inventions, in the performance of
activities under the Dedicated Clean Room Collaboration.

A-4

 

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“Intellectual Property” means all information, data, works of authorship,
discoveries, concepts, technology, method, know how, designs, processes,
software, algorithms and inventions, whether patentable or not, including,
without limitation, those that could be the subject of patent, copyright,
industrial design, trade secret or other forms of protection; including, without
limitation, all (i) patent applications (including, but not limited to any and
all priority applications, provisionals, non-provisionals, divisionals,
continuations, continuations-in-part, reissues, reexaminations, substitutions,
renewals) including the right to claim the benefit of priority to any of the
foregoing; (ii) patents granting on any of (i); (iii) extensions and
supplemental protection certificates based on any of (i) and (ii); (iv)
trademark applications, registrations, service marks, domain names and all
renewals and extensions thereto; and (v) copyright applications and
registrations and all restorations, reversions, renewals and extensions thereof.

“Know-How” means any proprietary data, results, material(s), and nonpublic
information of any type whatsoever, in any tangible or intangible form,
including know-how, trade secrets, practices, techniques, methods, processes,
inventions, discoveries, developments, specifications, formulations, formulae,
materials or compositions of matter of any type or kind (patentable or
otherwise), software, algorithms, marketing reports and plans, market research,
expertise (including experts’ information), test data (including
pharmacological, biological, chemical, biochemical, toxicological, preclinical
and clinical test data), analytical and quality control data, stability data,
other study data and procedures.

“Laws” means, with respect to BridgeBio, all laws, statutes, rules, regulations,
directives, decisions, ordinances, guidelines and other pronouncements of any
Governmental Authority currently in effect or enacted or promulgated during the
Term, and as amended from time to time, of each jurisdiction in which the
Product is produced, marketed, distributed, used or sold; and with respect to
Catalent, all laws, statutes, rules, and regulations currently in effect or
enacted or promulgated during the Term, and as amended from time to time, of the
jurisdiction in which Catalent Manufactures the BridgeBio Product, including
cGMP.

“Licensed Purpose” means for the worldwide Development, Manufacture and
Commercialization of BridgeBio Products that are the subject of a BridgeBio
Manufacturing and Supply Agreement.

“Manufacture” or “Manufacturing” means all activities, whether performed by a
Party or a Third Party designee of a Party, related to the manufacturing of a
product, or any ingredient thereof, including manufacturing for clinical use or
commercial sale, in process and product testing, release of product, quality
assurance activities related to manufacturing and release of product, handling
and storage of product and ongoing stability tests, packaging and labeling, and
regulatory activities related to any of the foregoing.

“Manufacturing Process” or “Process” means the process, or applicable portion(s)
thereof for the manufacture, analysis, validation, testing, documentation,
quality evaluation, storage, and shipping of components, intermediates and
BridgeBio Product(s) pursuant to a Definitive Agreement as such process may be
developed and/or changed from time to time in accordance with a Definitive
Agreement.

A-5

 

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“Marketing Authorization Application” or “MAA” means an application to the
appropriate Regulatory Authority for approval to sell a BridgeBio Product (but
excluding Pricing Approval) in any particular country or regulatory
jurisdiction, including such application filed with the EMA pursuant to the
Centralized Procedure or with the applicable Regulatory Authority of a country
in accordance with such country’s national approval procedure.

“Patents” means (i) all national, regional and international patents and patent
applications, including provisional patent applications, (ii) all patent
applications filed either from such patents, patent applications or provisional
applications or from an application claiming priority from either of these,
including divisionals, continuations, continuations-in-part, provisionals,
converted provisionals and continued prosecution applications, (iii) any and all
patents that have issued or in the future issue from the foregoing patent
applications ((i) and (ii)), including utility models, petty patents and design
patents and certificates of invention, (iv) any and all extensions or
restorations by existing or future extension or restoration mechanisms,
including revalidations, reissues, re-examinations and extensions (including any
supplementary protection certificates and the like) of the foregoing patents or
patent applications ((i), (ii), and (iii)) and (v) any similar rights, including
so-called pipeline protection or any importation, revalidation, confirmation or
introduction patent or registration patent or patent of additions to any of such
foregoing patent applications and patents.

“Person” means any corporation, limited or general partnership, limited
liability company, joint venture, trust, unincorporated association,
governmental body, authority, bureau or agency, any other entity or body, or an
individual.

“Pricing Approval” means the approval, agreement, determination or decision from
a Governmental Authority establishing the price and/or reimbursement for a
BridgeBio Product for sale in a given country or regulatory jurisdiction, as
required by applicable Laws in such country or other regulatory jurisdiction
prior to the sale of the BridgeBio Product in such country or regulatory
jurisdiction.

“Procurement Costs” means the actual price paid by Catalent to Third Parties for
the procurement of materials and supplies used in the Manufacture of BridgeBio
Products.  Procurement Costs do not include the Procurement Fee.

“Procurement Fee” means the fee that is paid to Catalent for its services in the
procurement of materials and supplies used in the Manufacture of BridgeBio
Products, such fee being a certain percentage of the Procurement Costs.  The
Procurement Fee shall be set forth in each BridgeBio Manufacturing and Supply
Agreement; provided that, and notwithstanding any other provision in the
Definitive Agreements to the contrary, [***].

“Product Approval” means, with respect to a BridgeBio Product, the approval of a
Governmental Authority necessary for the marketing and sale in a given country
or regulatory jurisdiction, which may include the approval of an MAA (but shall
not include any Pricing Approvals).

“Quality Agreement” means the Quality Agreements by and between BridgeBio and
Catalent, entered into pursuant to a BridgeBio Manufacturing and Supply
Agreement.

A-6

 

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“Quality Control/Quality Assurance Release” means the certification by Catalent
that the BridgeBio Product is released in compliance with the cGMPs and the
applicable Quality Agreement.

“Regulatory Acts” means any rules, regulations, directives, decisions,
ordinances, guidelines and other pronouncements of any Regulatory Authority.

“Regulatory Approvals” means, with respect to a BridgeBio Product or a facility
for the Manufacture of a BridgeBio Product or component thereof, all filings and
approvals (including, as applicable, IND filings, Product Approvals, Pricing
Approvals, establishment license approvals and, in each case any supplements and
amendments thereto), licenses, registrations or authorizations of any
Governmental Authority necessary to obtain marketing authorization for or to
Develop, Manufacture or Commercialize a BridgeBio Product, as applicable, for or
in a particular country or regulatory jurisdiction.

“Regulatory Authority” means, in a particular country or regulatory
jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval in such country or regulatory jurisdiction, including (i) in
the U.S., the FDA, and (ii) in the EU, the EMA, the European Commission and
relevant national medicines regulatory authorities.

“Regulatory Exclusivity” means, with respect to BridgeBio Products, any
exclusive marketing rights or data exclusivity rights conferred by any
Governmental Authority with respect to the BridgeBio Products other than a
Patent right, including in the European Union, Regulation (EC) No 726/2004 and
Directive 2001/83/EC (as amended).

“Regulatory Materials” means, with respect to BridgeBio Products or the
facilities used to Manufacture BridgeBio Products or a component thereof, as
applicable, regulatory applications, submissions, notifications, communications,
correspondence, registrations, Regulatory Approvals and/or other filings made
to, received from or otherwise conducted with a Regulatory Authority that are
necessary in order to obtain marketing authorization for or to Develop,
Manufacture or Commercialize a BridgeBio Product or to use a facility for the
Manufacture thereof, for or in a particular country or regulatory jurisdiction,
including all rights under the foregoing, including rights to clinical data and
Regulatory Exclusivity.  Regulatory Materials include BLAs, INDs, MAAs,
presentations, responses, applications for Product Approvals and granted Product
Approvals.

“Regulatory Warning Notices” means Form FDA 483 Inspectional Observations,
Establishment Inspection Reports, warning letters, or their equivalents and any
similar correspondences received from the FDA or any other Governmental
Authority having jurisdiction over a BridgeBio Product or any facility for the
Manufacture of a BridgeBio Product or component thereof.

“Representatives” means a Party’s (and its Affiliates’) directors, officers,
full-time employees, part-time employees, temporary workers, subcontractors,
consultants, agents, permitted sublicensees (if any) and legal, technical, and
business advisors.

A-7

 

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“Strategic Partners” means the individuals or entities that are part of a
strategic partnership, which is a relationship between two commercial
enterprises formalized by one or more business contracts.  

“Technology” means all inventions, methods, techniques, trade secrets,
copyrights, Know-How, knowledge, data, developments, discoveries, documentation,
experience, formulas and formulations, proprietary information, processes, test
procedures, hardware, software and other intellectual property of any kind,
whether or not protectable under patent, trademark, copyright or similar Law.

“Territory” means worldwide.

“Third Party” means any Person other than the Parties.

“U.S.” means the United States of America and its possessions and territories.

1.2

Additional Definitions.  The following terms have the meanings set forth in the
corresponding Sections of this Agreement:

 

Defined Term

 

Section

AAV

 

Recitals

Action

 

11.3(b)

Additional Manufacturing and Supply Agreement

 

1.3

Auditing Party

 

5.6

BEqs

 

Exh. C

BridgeBio Arising IP

 

10.5

BridgeBio Entities

 

Recitals

BridgeBio Products

 

Recitals

BridgeBio Indemnitee

 

11.6

BridgeBio-Requested Equipment Use Fee

 

9.3

BridgeBio-Requested Equipment Cost

 

9.3

BridgeBio Manufacturing and Supply Agreement

 

Recitals

Catalent Arising IP

 

10.4

Catalent Indemnitee

 

11.7

Catalent Use Credit

 

9.2(b)

Catalent Use Request

 

9.2(b)

Clean Room Use Fee

 

3.1(b)

Clean Room Use Fee Invoice

 

9.2(a)

CMC

 

5.1

Dedicated Clean Room Collaboration

 

Recitals

Definitive Agreements

 

1.1

Development Services

 

Exh. C

Disclosing Party

 

8.3(a)

Disclosure Agreement

 

8.2

Effective Date

 

Preamble

Force Majeure Event

 

7.1

A-8

 

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GMP Agreement

 

8.2

Joint Steering Committee

 

4.1

Licensed Subject Matter

 

6.2(b)

Paragon

 

8.2

Proposed Transaction

 

Recitals

Readiness Determination

 

3.1(b)

Receiving Party

 

8.3(a)

Repeat Supply Failure

 

Exh. C

Retained Copies

 

12.2(g)

Supply Failure

 

Exh. C

Term

 

12.1(a)

 

 

 

A-9

 

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EXHIBIT B

[***]

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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EXHIBIT B

MINIMUM ANNUAL THRESHOLD AND FORECASTING

 

The Dedicated Clean Room Collaboration was formed under the Collaboration
Agreement to establish the overall dedication and governance of the Dedicated
Clean Room Suite that have been dedicated for the Manufacture of BridgeBio’s
Products.  As part of the Dedicated Clean Room Collaboration, the Parties agreed
to and have formed a Joint Steering Committee (“JSC”) that is comprised of
members from each Party and, among other things, reviews, coordinates and
schedules the use of the Dedicated Clean Room Suite for clinical and commercial
Manufacturing and the forecasting, ordering and Delivery of Batches of BridgeBio
Product that are the subject of an Additional Manufacturing and Supply
Agreement, including a BridgeBio Manufacturing and Supply Agreement.

 

This Exhibit B establishes the Parties understanding as to (i) minimum annual
ordering obligations for the Manufacture of clinical and/or commercial supply of
BridgeBio Products in the Dedicated Clean Room Suite following the Readiness
Determination, (ii) the establishment of procedures for the initial forecasting
and rolling forecasts of BridgeBio’s ordering of clinical and/or commercial
supply Manufacturing of the BridgeBio Products in the Dedicated Clean Room
Suite, and (iii) any other services to be performed by Catalent for BridgeBio to
which the Parties mutually agree.

 

Article I
DEFINITIONS

1.1Definitions.  Unless otherwise defined in this Exhibit B or below, all
capitalized terms used herein shall have the meanings specified in the
Collaboration Agreement.

(a)“Batch Fee Framework” means the definition provided in a BridgeBio
Manufacturing and Supply Agreement and any Additional Manufacturing and Supply
Agreements for the applicable BridgeBio Product pertaining to the method of
calculating the Batch price which takes into account, among other things, the
Batch processing time and the Manufacturing Process.

(b)“Manufacture/Release Period” means the period of time required for the
manufacture and release of the BridgeBio Product commencing on the Manufacturing
Start Date (such period being determined and approved by the JSC) and concluding
on the Delivery of the Batch Documentation to BridgeBio for its review.

(c)“Manufacturing Configuration” means the Manufacturing Process configuration
involving one upstream production run using [***] and one subsequent downstream
purification run.

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

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(d) “Manufacturing Supply Pricing” means, for clinical supply for a BridgeBio
Entity during the Term, the pricing set forth in Schedule 1.1 of this Exhibit B,
and for all other clinical and commercial supply Manufacturing, the definition
provided in each BridgeBio Manufacturing and Supply Agreement and any Additional
Manufacturing and Supply Agreements for the applicable BridgeBio Product.

(e)“Maximum Upstream Runs” means the maximum number of upstream production runs
that can be completed in the Dedicated Clean Room Suite during a Dedicated
Manufacturing Period and is based on the number of [***] that the Parties
mutually agree can be safely and efficiently operated in the Dedicated Clean
Room Suite.

(f)“Minimum Annual Threshold” means the minimum dollar amount that must be paid
by, or caused to be paid by, BridgeBio to Catalent for BEqs each calendar year.

Article II
SCOPE OF THIS EXHIBIT

2.1Batch Pricing Based on Manufacturing Configuration.  Each BridgeBio Product
being Manufactured by Catalent pursuant to future supply agreement/s may have
differing Manufacturing Configurations.  In addition, such Manufacturing
Configurations may change during the Term for the same BridgeBio
Product.  Accordingly, the Parties have agreed to establish a Batch Fee
Framework, whereby the Batch Price for commercial supply of any BridgeBio
Product varies depending upon the Manufacturing Configuration utilized in the
Manufacture of such Batch, which prices shall be set forth in each BridgeBio
Supply Agreement. [***]

2.2Minimum Annual Requirements.  As consideration for Catalent’s agreement to
exclusively dedicate the Dedicated Clean Room Suite to BridgeBio, BridgeBio
agrees to the minimum purchase obligations set forth in Sections 3.3 and 3.4
hereof.  

Article III
CLINICAL MANUFACTURE AND COMMERCIAL SUPPLY

3.1General Requirements. Catalent is preparing the Dedicated Clean Room Suite
for the Manufacture of clinical and commercial supply of BridgeBio Products,
with the initial clinical supply comprised of the BridgeBio Products.  While
commercial supply of BridgeBio Products is the intended ultimate use of the
Dedicated Clean Room Suite, the Parties agree that the Manufacture of clinical
supply of BridgeBio Products may also be conducted in the Dedicated Clean Room
Suite as provided for in one or more BridgeBio Supply Agreements and as
determined by the JSC.

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

B-3

 

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3.2Manufacturing Start Date.  For each BridgeBio Product to be Manufactured in
the Dedicated Clean Room Suite, the date on which BridgeBio intends for Catalent
to commence, and the date on which Catalent must be ready to commence, clinical
or commercial Manufacture of Batches of BridgeBio Products has been or will be
specified in writing delivered by BridgeBio to Catalent at least [***] prior to
such date and is referred to herein as the “Anticipated Manufacturing Start
Date”; and the date on which Catalent actually commences commercial Manufacture
of Batches of BridgeBio Products in such suite is referred to herein as the
“Manufacturing Start Date”, which date shall not be any earlier than the
Readiness Determination Date.  

3.3Minimum Annual Threshold.  

3.3.1Commencing upon the Readiness Determination through the Term, [***],
BridgeBio shall submit Binding Purchase Orders (or by other mutual agreement)
for (a) Batches of BridgeBio Products to be Manufactured by Catalent in the
Dedicated Clean Room Suite and (b) Development and Manufacturing services
associated with BridgeBio Products to be performed by Catalent outside the
Dedicated Clean Room (the “Development Services”).  For each BMP, revenue
associated with Batches of BridgeBio Products Delivered by Catalent [***]. The
Purchase Orders for each BMP shall not exceed the Maximum Batches (defined
below). Subject to BridgeBio’s right to make adjustments to the Initial and
Rolling Forecasts as provided for in Section 3.5 (and thereby to any Purchase
Order relating thereto), BridgeBio shall issue each binding Purchase Order at
least [***] prior to the start of the BMP to which the Purchase Order applies.  

3.3.2Upon the Readiness Determination, the Minimum Annual Threshold shall be
based upon the Manufacturing Supply Pricing of [***] Batches of BridgeBio
Products to be Manufactured in the Dedicated Clean Room Suite during the BMP for
that FY (referred to herein as the “Minimum Batches”) and shall be [***].  The
Manufacturing Supply Pricing that used for calculating the Minimum Annual
Threshold is set forth in Schedule 1.1 to this Exhibit B.  Starting in 2022, the
Minimum Annual Threshold may be increased year over year [***]  Fees or expenses
for the procurement of Raw Materials or other direct costs that are charged at
cost plus a Procurement Fee do not count towards meeting the Minimum Annual
Threshold.

3.3.3In the event that BridgeBio fails to order, or fails to cause BridgeBio
Entities or Strategic Partners to order, sufficient quantities of Batches of
BridgeBio Products to meet the Minimum Annual Threshold, Catalent shall submit
an invoice to BridgeBio following the conclusion of the BMP during which the
minimums were not achieved for the difference between the aggregate Batch Price
associated with the Batches of BridgeBio Products ordered by BridgeBio for
Delivery in such BMP and the applicable minimum threshold amount.  BridgeBio
shall make payment on undisputed invoices within [***] of receipt.

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

B-4

 

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3.4Purchase Orders; Forecasts; Procedures.

3.4.1Upon receipt of a Purchase Order from BridgeBio pursuant to a BridgeBio
Manufacturing and Supply Agreement and/or one or more Additional Manufacturing
and Supply Agreements, Catalent shall Manufacture Batches of BridgeBio Product
at the BWI Facility in accordance with the Product Requirements, cGMPs, the
then-current Quality Agreement and any applicable Laws and otherwise in
accordance with the applicable Definitive Agreement.  The maximum number of
Batches of BridgeBio Product that can be Manufactured in the Dedicated Clean
Room Suite (the “Maximum Batches”) at any time during the Term is based upon the
Manufacturing Configuration established for each BridgeBio Product and the
maximum number of upstream production runs that can be safely and efficiently
completed in the Dedicated Clean Room Suite (the “Maximum Upstream Runs”) during
each BMP.  The Maximum Upstream Runs, and the corresponding Maximum Batches,
shall be determined by the JSC.  The JSC will make an initial determination of
the Maximum Batches and Maximum Upstream Runs upon the Readiness Determination
and the JSC will review the Maximum Upstream Runs periodically (no less than
annually) and make appropriate adjustments thereto.

3.4.2With respect to orders of Batches of the BridgeBio Product and subject to
the Maximum Batches, BridgeBio shall provide forecasts of its ordering needs and
place with Catalent Purchase Orders for the supply of BridgeBio Products being
Manufactured by Catalent pursuant to one or more BridgeBio Manufacturing and
Supply Agreement and/or one or more Additional Manufacturing and Supply
Agreements.  

3.5Initial Forecast.

3.5.1At least [***] prior to the initial Anticipated Manufacturing Start Date of
one or more BridgeBio Products in the Dedicated Clean Room Suite, BridgeBio or
another BridgeBio Entity shall provide to Catalent forecasts of its Batch
requirements for the Delivery of BridgeBio Product for the [***] immediately
following the period of time required for the manufacture and release of the
BridgeBio Product commencing on the Manufacturing Start Date (such period being
determined and approved by the JSC and referred to herein as the
“Manufacture/Release Period”) (the forecast being the “Initial
Forecast”).  BridgeBio may also include in the Initial Forecast the Batch needs
of the other BridgeBio Entities and Strategic Partners that are being
Manufactured by Catalent pursuant to an Additional Manufacturing and Supply
Agreement. However, for the avoidance of doubt and notwithstanding the Batches
being Manufactured by Catalent for the BridgeBio Entities or Strategic Partners,
BridgeBio shall not be relieved of its obligation to meet the Minimum Annual
Threshold.  [***]

3.5.2Subject to the Initial Forecast Refresh (defined below) and the rights to
make other adjustments set forth herein, the Initial Forecasts will be binding
as to the [***] Dedicated Manufacturing Period (each such period for the purpose
of this section being the “Binding Manufacturing Period” or “BMP”) and
non-binding as to the subsequent Dedicated Manufacturing Period (such period for
the purpose of this section being the “Non-Binding Manufacturing Period” or
“NBMP”).  [***]. Thus, the Initial Forecast periods are summarized as follows:

[***]

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

B-5

 

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It is the intention of the Parties that the BMP for each FY shall commence on
[***].  For each BMP in the Initial Forecast, BridgeBio may adjust the number of
Batches no later than [***] prior to the start of [***] (the “Initial Forecast
Refresh”), provided that BridgeBio shall be obligated to purchase services that
utilize the Dedicated Clean Room Suite and/or the number of Batches of any
BridgeBio Product equivalent to, or otherwise make payment to Catalent, of an
amount equal to or greater than the Minimum Annual Threshold. The Initial
Forecast and subsequent Rolling Forecasts shall be provided by BridgeBio to
Catalent in a form of notice substantially similar to the example notice
provided in Attachment A.  

3.5.3Rolling Forecast.  Prior to the first day of [***] of the Initial Forecast
and every year thereafter, BridgeBio will refresh its forecast, and the [***]
(such forecasting then becomes the “Rolling Forecast”).  

3.5.4Forecast Modification; Monitoring.  In addition to the [***], BridgeBio
will be afforded the flexibility to make modification requests to the Initial
and Rolling Forecasts, as set forth below (each a “Forecast Modification”).  If
a Forecast Modification is made prior to or [***] that requests additional
Batches of BridgeBio Product over what was originally forecast (the “Additional
Batches”), Catalent shall use commercially reasonable efforts, but shall not be
obligated, to Manufacture the Additional Batches.  If the Forecast Modification
results in a reduction of Batches to be Delivered by Catalent during the [***],
BridgeBio shall be obligated to pay Catalent for all Batches ordered for
[***].  During the period in which Catalent is Manufacturing BridgeBio Product,
the JSC will have periodic teleconferences or meetings to monitor and review the
status of Manufacturing operations and to address any issues that may arise.

3.5.5Delivery Dates.  Within [***] following Catalent’s receipt of the Initial
Forecast and each Rolling Forecast thereafter, Catalent shall prepare, with
input from BridgeBio, and submit to the JSC a Batch production schedule for the
next [***] which includes the order of production of each Batch of BridgeBio
Product forecasted and the anticipated delivery of the Batch Documentation for
each such Batch to BridgeBio (the “Proposed Production Schedule”). Within [***]
following receipt of the Proposed Production Schedule from Catalent, the JSC
shall review and adjust as necessary the Proposed Production Schedule, [***] For
each Batch of BridgeBio Product being Manufactured during [***], the Approved
Production Schedule for that Batch shall be based upon reasonable time estimates
for the Manufacture/Release Period, delivery of Batch Documentation, BridgeBio’s
review and approval of the Batch Documentation and a reasonable amount of time
for the investigation and clearance of deviations that may have occurred during
the Manufacture/Release Period. Within [***] upon BridgeBio’s approval of the
Approved Production Schedule, each BridgeBio Entity and Strategic Partner shall
submit to Catalent Purchase Orders specifying the number of Batches and the
anticipated delivery dates (as specified in the Approved Production
Schedule).  [***] All Purchase Orders submitted in compliance with a BridgeBio
Manufacturing and Supply Agreement and/or one or more Additional Manufacturing
and Supply Agreements shall be binding on Catalent.  No later than [***] after
BridgeBio’s

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

B-6

 

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submission of a Purchase Order, Catalent shall provide BridgeBio with written
acknowledgment of receipt of the Purchase Order.  Catalent shall timely
Manufacture and Deliver the amounts ordered by BridgeBio in accordance with this
Section 3.5.5, and Catalent shall use commercially reasonably efforts to
Manufacture and Deliver any Additional Batches; it being understood that
Catalent’s failure to supply such Additional Batches shall not constitute a
breach under this Agreement.

3.5.6Supply Failure.  [***]

3.5.7Delays and Suspensions.  The provisions in this Section 3.5 are intended to
apply to situations involving the ongoing, uninterrupted Manufacture of
BridgeBio Products, including orders for [***]  In the event of delays in
approval or commercial launch or suspension of production after initial launch
(for reasons other than the negligence (or more culpable conduct) of Catalent or
a breach of this Agreement by Catalent) and if (for reasons other than the
negligence (or more culpable conduct) of Catalent or a breach of this Agreement
by Catalent) BridgeBio is unable to increase orders for the Manufacture of other
BridgeBio Products in the Dedicated Clean Room Suite, BridgeBio shall pay to
Catalent the Minimum Annual Threshold (as the same may be offset by work
conducted in such suites pursuant to a Scope of Work or Purchase Orders) for as
long as the Manufacture of the BridgeBio Product is delayed or suspended, and
there shall be no additional payments or costs arising from BridgeBio’s
provision of the Rolling Forecast (including the binding portion thereof) or
actual Purchase Orders placed other than for the Manufacture of Batches which
have commenced and for the non-cancelable orders of Raw Materials.

3.6Clean Room Use Fee Credits.  

3.6.1Batch Credit.  [***].

3.6.2Catalent Use Credit.  If the Dedicated Clean Room Suite is not being fully
utilized for the Manufacture of BridgeBio Products, Catalent may make a request
to BridgeBio to use the underutilized suite for Manufacturing on behalf of other
Catalent customers (a “Catalent Use Request”).  Each Catalent Use Request
submitted to BridgeBio shall provide the schedule during which the suite (or
rooms within the suite) will be used and the nature of the Manufacturing
activities that will be performed in the suite (or rooms), subject to any
confidentiality requirements between Catalent and its customers.  [***]

3.6.3Reconciliation. The CRUF Credits shall be determined by Catalent prior to
issuing the Clean Room Use Fee Invoice (as defined in the Collaboration
Agreement[***]  The maximum combined CRUF Credits in a BMP is equal to [***] of
the Clean Room Use Fee.  [***].

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

B-7

 

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EXHIBIT B, ATTACHMENT A
[***]

 

To:

 

 

From:

 

Date:

 

 

 

BridgeBio's Initial & Rolling Forecast for Batches of Bulk Drug Substance

 

Name of BB Entity (and SP)

Product Name

Product Ref #

Batch Requirements for [***] & Order of Delivery

Batch Requirements for [***]

 

[●]

[●]

 

 

[●]

[●]

[●]

 

 

[●]

[●]

[●]

 

 

[●]

[●]

[●]

 

 

[●]

[●]

[●]

 

 

Totals

 

 

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Exhibit B, A-1

 

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EXHIBIT B, Schedule 1.1

Manufacturing Supply Pricing*

 

 

Clinical Supply

Manufacturing Configurations

Description

BMC: [***]**

MC2: [***]

MC3: [***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

 

 

Engineering Batches

Manufacturing Configurations

Description

BMC: [***]

MC2: [***]

MC3: [***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Exhibit B, 1.1-1

 

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EXHIBIT B, Schedule 3.6.1

Illustrations of Batch Credit Calculation

 

 

Manufacturing Fees, BEqs and Batch Credit per BMP

 

Manufacturing Fees (USD)*

BEqs

Batch Credit (%)

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

* Based upon the current Manufacturing Supply Pricing for the BMC, See Schedule
1.1 of Exhibit B [***].

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Exhibit B, 3.6.1-1

 

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EXHIBIT B, Schedule 3.6.1 (CONT.)

Illustrations of Batch Credit Calculation

 

 

The following examples are for the sole purpose of illustrating the Batch Credit
calculation.  Batch credits start with BEqs in [***] increments over [***].  For
each [***] BEqs, Catalent will provide a credit of [***] towards the Clean Room
Use Fee.

 

Example 1.  

 

[***]

 

Example 2.  

 

[***]

 

Example 3.  

 

[***]

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Exhibit B, 3.6.1-2

 

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EXHIBIT B, Schedule 3.6.2

Illustrations of Catalent Use Credit Calculation

 

The following examples are for the sole purpose of illustrating the Catalent Use
Credit calculation.  

 

Example 1.  

 

[***]

 

Example 2.  

 

[***]

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Exhibit B, 3.6.2-1

 

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EXHIBIT C

DEDICATED CLEAN ROOM SUITE FLOOR PLAN

 

[***]

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

C-1

 

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Exhibit C – Dedicated Clean Room Floor Plan (yellow highlighted area)

 

[***]

 

Exhibit C – Dedicated Clean Room Floor Plan (cont.) (yellow highlighted area –
zoomed in)

 

 

[***]

 

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

C-2

 

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EXHIBIT D

BASE EQUIPMENT PACKAGE

 

[***]

 

 

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

D-1

 

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Schedule 3.1(b)

 

Readiness DETERMINATION check List

 

 

 

 

 

 

 

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Schedule 3.1(b)-1

 

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Schedule 2.2

 

Summary of Key Milestones

for Dedicated Clean Room Suite at the BWI Facility

 

Milestone

Approx.

Start Date

Approx.

Finish Date

Process Equipment Procurement and Installation

[***]

[***]

Construction Turnover

[***]

Commissioning/ Qualification/ Validation

[***]

[***]

cGMP Manufacturing

[***]

[***]

 

 

 

[***] Certain confidential portions (indicated by brackets and asterisks) have
been omitted from this exhibit in accordance with the rules of the Securities
and Exchange Commission.

 

Schedule 2.2-1

 

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