EXECUTION VERSION

Exhibit 10.28
Certain portions of this exhibit have been omitted pursuant to Rule 601(b)(10)
of Regulation S-K The omitted information is (i) not material and (ii) would
likely cause competitive harm to Biohaven Pharmaceutical Holding Company Ltd. if
publicly disclosed. Information that has been omitted has been noted in this
document with a placeholder identified by the mark “[***]”.
ZYDIS® COMMERCIAL SUPPLY AGREEMENT(Rimegepant / BHV3000)
This Zydis® Commercial Supply Agreement is made as of this 29th day of June,
2018 (“Effective Date”), by and between Biohaven Pharmaceuticals, Inc., a
Delaware corporation with a place of business at 234 Church Street, Suite 301,
New Haven, CT 06510, USA (“Client”), and Catalent U.K. Swindon Zydis Limited, a
company organized under the laws of Scotland (registered number SCO70961) with a
place of business at Frankland Road, Blagrove, Swindon, Wiltshire, UK SN5 8YG
(“Catalent”).
RECITALS
A.Client develops, markets and sells pharmaceutical products;
B.Catalent is a leading provider of advanced technologies, and development,
manufacturing and packaging services for pharmaceutical, biotechnology and
consumer healthcare companies;
C.Catalent and its Affiliates have developed and licensed proprietary technology
for the manufacture of the patented Zydis® Fast Dissolving Dosage Form (“Zydis”)
for the administration of pharmaceutical drugs (collectively, along with the
Zydis Patents and all data, results and information relating to Zydis and the
Zydis Patents (whether produced prior to or after the Effective Date), the
“Zydis Technology”);
D.Client and Catalent have entered into a Zydis Development and License
Agreement dated November 20, 2017 (the “Development Agreement”), pursuant to
which Catalent developed a Zydis formulation of the API (as defined below);
E.Client desires to have Catalent provide the services set forth in this
Agreement (as defined below) in connection with Client’s Product (as defined
below), and Catalent desires to provide such services, all pursuant to the terms
and conditions in this Agreement.
        THEREFORE, in consideration of the circumstances described above and the
mutual covenants, terms and conditions set forth below, the parties agree as
follows:
ARTICLE 1
DEFINITIONS
The following terms have the following meanings in this Agreement:
1.1 “Acknowledgement” has the meaning set forth in Section 4.3(B).

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1.2 “Affiliate(s)” means, with respect to Client or any Third Party, any Person,
other than Client or such Third Party, that directly or indirectly controls, is
controlled by or is under common control with Client or such Third Party; and
with respect to Catalent, Catalent, Inc. and any corporation, firm, partnership
or other entity controlled by it. For purposes of this definition, “control”
means (a) the possession, directly or indirectly, of the power to direct the
management or policies of a Person, whether through the ownership of voting
securities or by contract relating to voting rights or corporate governance, or
(b) the ownership, directly or indirectly, of more than fifty percent (50%) of
the voting securities or other ownership interest of a Person.
1.3 “Agreement” means this document, including all its Attachments and other
appendices (all of which are incorporated by reference) and any amendment to any
of the foregoing made in accordance with Section 18.1.
1.4 “API” means the compound (5 S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6, 7 ,8,
9-tetrahydro-5H-cyclohepta[b ]pyridin-9-yl 4-(2-oxo-2,3-dihydro-l H-imidazo[
4,5-b ]pyridin-1-yl)piperidine-1-carboxylate, also known as rimegepant and
BHV3000, or a salt thereof.
1.5 “API Inventions” has the meaning set forth in Article 11.
1.6 “Applicable Laws” means, with respect to Client, all laws, ordinances, rules
and regulations, currently in effect or enacted or promulgated during the Term,
and as amended from time to time, of each jurisdiction in which API or Product
is produced, marketed, distributed, used or sold; and with respect to Catalent,
all laws, ordinances, 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 Processes Product, including cGMP; provided,
however, that with respect to cGMP, Catalent shall comply with the laws,
ordinances, rules and regulations currently in effect or enacted or promulgated
during the Term, and as amended from time to time, of the U.S, Europe and
following its separation from the European Union, the United Kingdom.
1.7 “Batch” means a defined quantity of Product that has been or is being
Processed in accordance with the Specifications.
1.8 “Catalent” has the meaning set forth in the introductory paragraph, or any
successor or permitted assign. Catalent shall have the right to cause any of its
Affiliates to perform any of its obligations hereunder, and Client shall accept
such performance as if it were performance by Catalent.
1.9 “Catalent Defective Processing” has the meaning set forth in Section 5.2.
1.10 “Catalent Indemnitees” has the meaning set forth in Section 13.2.
1.11 “Catalent IP” has the meaning set forth in Article 11.
1.12 “CGRP Compound” means any molecule that is designed to bind to either
calcitonin gene related peptide (“CGRP”) or a CGRP.
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1.13 “cGMP” means current Good Manufacturing Practices promulgated by the
Regulatory Authorities in the jurisdictions included in Applicable Laws (as
applicable to Client and Catalent respectively). In the United States, this
includes 21 C.F.R. Parts 210 and 211, as amended; and in the European Union,
this includes 2003/94/EEC Directive (as supplemented by Volume 4 of EudraLex
published by the European Commission), as amended, if and as implemented in the
relevant constituent country.
1.14 “Client” has the meaning set forth in the introductory paragraph, or any
successor or permitted assign.
1.15 “Client Indemnitees” has the meaning set forth in Section 13.1.
1.16 “Client IP” has the meaning set forth in Article 11.
1.17 “Client-supplied Materials” means any materials to be supplied by or on
behalf of Client to Catalent for Processing, as provided in Attachment B,
including API and reference standards.
1.18 “Collaborator” means, with respect to Client, any Person other than an
Affiliate, that contractual privity with Client or an Affiliate of Client which
is engaged in the research, development, commercialization, marketing,
distribution, sales or support of drug substances or drug products on behalf of
Client or its Affiliates.
1.19 “Commencement Date” means the first date upon which a Regulatory Authority
approves Catalent as a manufacturer of any Product.
1.20 “Confidential Information” has the meaning set forth in Section 10.1.
1.21 “Contract Year” means each consecutive 12 month period beginning on the
Commencement Date or anniversary thereof, as applicable.
1.22 “Defective Product” has the meaning set forth in Section 5.2.
1.23 “Delayed Approval Fee” has the meaning set forth in Section 7.3.
1.24 “Development Agreement” has the meaning set forth in Recital D.
1.25 “Discloser” has the meaning set forth in Section 10.1.
1.26 “Effective Date” has the meaning set forth in the introductory paragraph.
1.27 “Exception Notice” has the meaning set forth in Section 5.2.
1.28 “Facility” means Catalent’s facility located in Swindon, UK; or such other
facility as agreed by the parties in writing.
1.29 “Firm Commitment” has the meaning set forth in Section 4.2.
1.30 “Invention” has the meaning set forth in Article 11.
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1.30.1 “Launch Date” means the date of first commercial sale of the Product made
by the Client into the Territory
1.31 “Losses” has the meaning set forth in Section 13.1.
1.32 “Minimum Requirement” has the meaning set forth in Section 4.1.
1.33 “Person” shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a government.
1.34 “Process” or “Processing” means (i) the qualification, validation and
stability services for the Product and (ii) the compounding, filling or
pressing, producing and bulk packaging (including initial blister packaging but
not secondary or retail packaging) of Client-supplied Materials and Raw
Materials into Product by Catalent, in accordance with the Specifications and
under the terms of this Agreement and the Quality Agreement.
1.35 “Processing Date” means the day on which the first step of physical
Processing is scheduled to occur, as identified in an Acknowledgement.
1.36 “Process Inventions” has the meaning set forth in Article 11.
1.37 “Product” means an orally disintegrating tablet pharmaceutical formulation
containing the API which product falls within the claims of the Zydis® Patents
or otherwise incorporates Zydis Technology, as more specifically described in
the Specifications. A “unit” of Product is one tablet.
1.38 “Product Maintenance Services” has the meaning set forth in Section 2.3.
1.39 “Purchase Order” has the meaning set forth in Section 4.3(A).
1.40 “Quality Agreement” has the meaning set forth in Section 9.6.
1.41 “Raw Materials” means all raw materials, supplies, components and packaging
necessary to manufacture and ship Product in accordance with the Specifications,
as provided in Attachment B, but excluding Client-supplied Materials.
1.42 “Recall” has the meaning set forth in Section 9.5.
1.43 “Recipient” has the meaning set forth in Section 10.1.
1.44 “Regulatory Approval” means each approval, permit, product and/or
establishment license, registration or authorization, including each approval
pursuant to U.S. Investigational New Drug Applications, New Drug Applications
and Abbreviated New Drug Applications (or equivalent non-U.S. filings, such as
European marketing authorization applications), as applicable, of a Regulatory
Authority that is necessary or advisable in connection with the
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development, manufacture, testing, use, storage, exportation, importation,
transport, promotion, marketing, distribution or sale of API or Product in the
Territory.
1.45 “Regulatory Authority” means an international, federal, state or local
governmental or regulatory body, agency, department, bureau, court or other
entity in the Territory that is responsible for (A) the regulation (including
pricing) of any aspect of pharmaceutical or medicinal products intended for
human use or (B) health, safety or environmental matters generally. In the
United States, this includes the United States Food and Drug Administration; and
in the European Union, this includes the European Medicines Agency.
1.46 “Representatives” of an entity means such entity’s duly authorized
officers, directors, employees, agents, accountants, attorneys or other
professional advisors.
1.47 “Review Period” has the meaning set forth in Section 5.2.
1.48 “Rolling Forecast” has the meaning set forth in Section 4.2.
1.49 “Specifications” means the procedures, requirements, standards, quality
control testing and other data and the scope of services as set forth in
Attachment B, as modified from time to time in accordance with Article 8.
1.50  “Term” has the meaning set forth in Section 16.1.
1.51 “Territory” means worldwide, but excluding 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. Catalent
shall not be obliged to Process Products for sale in any of such countries 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.
1.52 “Third Party” means shall mean any Person other than Catalent and its
Affiliates, and Client and its Affiliates and Collaborators.
1.53 “Unit” has the meaning set forth on Attachment C.
1.54  “Unit Pricing” has the meaning set forth in Section 7.1(B).
1.55 “Validation Services” has the meaning set forth in Section 2.1.
1.56 “Vendor” has the meaning set forth in Section 3.2(B).
1.57 “Zydis” has the meaning set forth in Recital C.
1.58 “Zydis Patents” has the meaning set forth in the Development Agreement.
1.59 “Zydis Technology” has the meaning set forth in Recital C.
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ARTICLE 2
VALIDATION, PROCESSING & RELATED SERVICES
2.1 Validation Services. Catalent shall perform the Product qualification,
validation and stability services described in Attachment A (the “Validation
Services”).
2.2 Supply and Purchase of Product. Catalent shall Process Product in accordance
with the Specifications, Applicable Laws and the terms and conditions of this
Agreement. During the Term, but no longer than for [***] from Commencement Date,
Client and its Affiliates shall purchase exclusively from Catalent all of
Client’s and its Affiliates’ requirements of Product in the Territory. Client
shall have no right to self-manufacture or to have a Third Party manufacture
Product unless Catalent is unable to supply Client with Client’s Minimum
Requirement for Product for a period of [***]. Catalent shall use commercially
reasonable efforts to ensure continuous supply of Product. In case of limited
manufacturing capacity, Catalent shall not disadvantage Processing of Product
compared to other products. Promptly after execution of this Agreement, the
parties shall develop a Product supply plan with the goal of ensuring a
continuous supply of Product to Client during the Term.
2.3 Product Maintenance Services. Catalent shall provide and Client will receive
those product maintenance services specified in Attachment D (the “Product
Maintenance Services”).
2.4 Other Related Services. Catalent shall provide other Product-related
services, other than Validation Services, Processing or Product Maintenance
Services, as either specified in Attachment D or agreed in writing by the
parties from time to time. Such writing shall include the scope and fees for any
such services and be appended to this Agreement. The terms and conditions of
this Agreement shall govern and apply to such services.
ARTICLE 3
MATERIALS
3.1 Client-supplied Materials.
A.Client shall supply to Catalent for Processing, at Client’s cost,
Client-supplied Materials, in quantities sufficient to meet Client’s
requirements for Product. Client shall deliver such items and associated
certificates of analysis to the Facility no later than [***] days (but not
earlier than [***] days) before the Processing Date. Client shall be responsible
at its expense for securing any necessary export, import or other governmental
clearance, permit or certification required in respect of such supply. Catalent
shall use Client-supplied Materials solely for Processing. Prior to delivery of
any Client-supplied Materials, Client shall provide to Catalent a copy of all
associated material safety data sheets, safe handling instructions and health
and environmental information and any governmental certification or
authorization that may be required under Applicable Laws relating to the API and
Product, and thereafter shall provide promptly any update thereto.
B.Catalent shall inspect all Client-supplied Materials received to verify their
identity. Unless otherwise expressly required by the Specifications, Catalent
shall have no
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obligation to test Client-supplied Materials it receives to confirm that they
meet the associated specifications, certificate of analysis or otherwise; but in
the event that Catalent detects a nonconformity with the Specifications,
Catalent shall give Client prompt notice of such nonconformity. Catalent shall
not be liable for any defect in Client-supplied Materials, or in Product as a
result of defective Client-supplied Materials, unless Catalent failed to
properly perform the foregoing obligations. Catalent shall follow Client’s
reasonable written instructions in respect of return or disposal of defective
Client-supplied Materials, at Client’s cost.
C.Client shall retain title to Client-supplied Materials at all times and shall
bear the risk of loss of any such Client-supplied Materials unless as a result
of gross negligence by Catalent.
3.2 Raw Materials.
A.Catalent shall be responsible for procuring, inspecting and releasing adequate
Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed
by the parties in writing. Catalent shall not be liable for any delay in
delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a
particular Raw Material necessary for Processing and (ii) Catalent placed orders
for such Raw Materials promptly following receipt of Client’s Firm Commitment.
In the event that any Raw Material becomes subject to purchase lead time beyond
the Firm Commitment time frame, the parties will negotiate in good faith an
appropriate amendment to this Agreement, including Section 4.2.
B.Client may require a specific supplier, manufacturer or vendor (“Vendor”) to
be used for Raw Material. In such an event, (i) such Vendor will be identified
in the Specifications and (ii) the Raw Materials from such Vendor shall be
deemed Client-supplied Materials for purposes of this Agreement. If the cost of
the Raw Material from any such Vendor is greater than Catalent’s costs for the
same raw material of equal quality from other vendors, Catalent shall add the
difference between Catalent’s cost of the Raw Material and the Vendor’s cost of
the Raw Material to the Unit Pricing. Client will be responsible for all costs
associated with qualification of any such Vendor that has not been previously
qualified by Catalent.
C.In the event of (i) a Specification change for any reason, (ii) obsolescence
of any Raw Material or (iii) termination or expiration of this Agreement, Client
shall bear the cost of any unused Raw Materials (including packaging) unusable
for Processing or Product and unused by Catalent for another customer, so long
as Catalent purchased such Raw Materials in quantities consistent with Client’s
most recent Firm Commitment and the vendor’s minimum purchase obligations.
3.3 Artwork and Labeling. Client shall provide or approve, prior to the
procurement of applicable Raw Material, all artwork, advertising and labeling
information necessary for Processing, if any. Such artwork, advertising and
labeling information is and shall remain the exclusive property of Client, and
Client shall be solely responsible for the content thereof. Such artwork,
advertising and labeling information or any reproduction thereof may not be used
by Catalent in any manner other than performing its obligations hereunder
without Client’s written consent.
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ARTICLE 4
MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS
4.1 Minimum Requirement. [***].
4.2 Forecast. On or before the 10th day of each calendar month, beginning at
least 6 months prior to the anticipated Commencement Date, Client shall furnish
to Catalent a written 12 month rolling forecast of the quantities of Product
that Client intends to order from Catalent during such 12-month period (the
“Rolling Forecast). The first 3 months of each Rolling Forecast shall constitute
a binding order for the quantities of Product specified in such Rolling Forecast
(the “Firm Commitment”) and the following 9 months of the Rolling Forecast shall
be non-binding, good-faith estimates.
4.3 Purchase Orders.
A.From time to time as provided in this Section 4.3(A), Client shall submit to
Catalent a binding, non-cancelable purchase order for Product specifying the
number of Batches to be Processed, the Batch size (to the extent the
Specifications permit Batches of different sizes) and the requested delivery
date for each Batch (each, a “Purchase Order”); provided, that all Purchase
Orders shall be in full batch quantities. Concurrently with the submission of
each Rolling Forecast, Client shall submit a Purchase Order for the Firm
Commitment. Purchase Orders for quantities of Product in excess of the Firm
Commitment shall be submitted by Client at least 150 days in advance of the
delivery date requested in the Purchase Order.
B.Promptly following receipt of a Purchase Order, Catalent shall issue a written
acknowledgement (each, an “Acknowledgement”) that it accepts or rejects such
Purchase Order. Each acceptance Acknowledgement shall either confirm the
delivery date set forth in the Purchase Order or set forth a reasonable
alternative delivery date, and shall include the Processing Date. Catalent may
reject any Purchase Order in excess of the Firm Commitment or otherwise not
given in accordance with this Agreement.
C.Notwithstanding Section 4.3(B), Catalent shall use commercially reasonable
efforts to supply Client with quantities of Product set forth in a Purchase
Order which are up to [***]% in excess of the quantities specified in the Firm
Commitment, subject to Catalent’s other supply commitments and manufacturing,
packaging and equipment capacity.
D.In the event of a conflict between the terms of any Purchase Order or
Acknowledgement and this Agreement, the terms of this Agreement shall control.
4.4 Catalent’s Cancellation of Purchase Orders. Notwithstanding anything in
Section 4.3 and 4.5 to the contrary, Catalent reserves the right to cancel all,
or any part of, a Purchase Order upon written notice to Client, and Catalent
shall have no further obligations or liability with respect to such Purchase
Order, if Client refuses or fails to supply conforming Client-supplied Materials
prior to the deadline set forth in Section 3.1. [***]
4.5 Client’s Modification or Cancellation of Purchase Orders.
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A. Client may modify the delivery date or quantity of Product in a Purchase
Order only by submitting a written change order to Catalent at least [***] days
in advance of the earliest Processing Date covered by such change order. Such
change order shall be effective and binding against Catalent only upon the
written approval of Catalent, and notwithstanding any such written approval,
Client shall remain responsible for the Firm Commitment.
B. Notwithstanding any amount due to Catalent under Section 4.1, if Client fails
to place Purchase Orders sufficient to satisfy the Firm Commitment, Client shall
pay to Catalent in accordance with Article 7 the Unit Pricing for all Units that
would have been Processed if Client had placed Purchase Orders sufficient to
satisfy the Firm Commitment.
C. [***]
4.6 Unplanned Delay or Elimination of Processing. Catalent shall use
commercially reasonable efforts to meet the Purchase Orders, subject to the
terms and conditions of this Agreement. Catalent shall provide Client with as
much advance notice as practicable if Catalent determines that any Processing
will be delayed or eliminated for any reason. If a delay in supply of Product,
which is solely due the Catalent, is the sole cause that Client is unable to
reach the Minimum Requirement, Client will only be obligated to pay for actual
Product delivered.
ARTICLE 5
TESTING; SAMPLES; RELEASE
5.1 Batch Records and Data; Release. Unless otherwise agreed to by the parties
during their ordinary course of dealings, after Catalent completes Processing of
a Batch, Catalent shall provide Client with copies of Batch records prepared in
accordance with the Specifications; provided, that if testing reveals an
out-of-Specification result, Catalent shall provide such Batch records promptly
following resolution of the out-of-Specification result. After Catalent
completes Processing of a Batch, Catalent shall also provide Client or its
designee with a certificate of analysis for such Batch. Issuance of a
certificate of analysis constitutes release of the Batch by Catalent to Client.
Client shall be responsible for final release of Product (including testing, at
its cost) to the market.
5.2 Testing; Rejection. Following Client’s receipt of a shipment of a Batch,
Client or Client’s designee may test samples of such Batch to confirm that the
Specifications have been met. Unless within 20 days after Client’s receipt of a
Batch (“Review Period”), Client or its designee notifies Catalent in writing (an
“Exception Notice”) that such Batch does not meet the warranty set forth in
Section 12.1 (“Defective Product”), and provides a sample of the alleged
Defective Product, the Batch shall be deemed accepted by Client and Client shall
have no right to reject such Batch. Upon timely receipt of an Exception Notice
from Client, Catalent shall conduct an appropriate investigation in its
discretion to determine whether it agrees with Client that Product is Defective
Product and to determine the cause of any nonconformity. If Catalent agrees that
Product is Defective Product and determines that the cause of nonconformity is
attributable to Catalent’s negligence or willful misconduct (“Catalent Defective
Processing”), then Section 5.4 shall apply. For avoidance of doubt, where the
cause of nonconformity cannot be determined or assigned, it shall be deemed not
Catalent Defective Processing.
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5.3 Discrepant Results. If the parties disagree as to whether Product is
Defective Product and/or whether the cause of the nonconformity is Catalent
Defective Processing, and this is not resolved within 30 days of the Exception
Notice date, the parties shall cause a mutually acceptable independent third
party to review records, test data and to perform comparative tests and/or
analyses on samples of the alleged Defective Product and its components,
including Client-supplied Materials. The independent party’s results as to
whether or not Product is Defective Product and the cause of any nonconformity
shall be final and binding. Unless otherwise agreed by the parties in writing,
the costs associated with such testing and review shall be borne by Catalent if
Product is Defective Product attributable to Catalent Defective Processing, and
by Client in all other circumstances.
5.4  Defective Processing. Catalent shall, at its option, either (A) re-Process
(or if re-Processing is not permissible under cGMPs, then replace), at its cost
any Batch of Defective Product attributable to Catalent Defective Processing
(and Client shall be liable to pay for either the rejected Batch(es) or the
replacement Batch(es), but not both), or (B) credit any payments made by Client
for such rejected Batch. THE OBLIGATION OF CATALENT TO RE-PROCESS (OR REPLACE)
DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE
BY CLIENT, IN EACH CASE WHICH DEFECTIVE PRODUCT IS ATTRIBUTABLE TO CATALENT
DEFECTIVE PROCESSING, SHALL BE CLIENT’S SOLE AND EXCLUSIVE REMEDY UNDER THIS
AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR
IMPLIED. FOR CLARITY, NOTWITHSTANDING THE FOREGOING, TO THE EXTENT CLIENT HAS A
RIGHT UNDER THIS AGREEMENT TO TERMINATE THIS AGREEMENT THAT DOES NOT ARISE FROM
OR RELATE TO DEFECTIVE PROCESSING PURSUANT TO ARTICLE 5, SUCH RIGHT TO TERMINATE
SHALL CONTINUE TO APPLY.

5.5 Supply of Material for Defective Product. In the event Catalent reprocesses
(or if re-Processing is not permissible under cGMPs, then replaces) Defective
Product pursuant to Section 5.4, Client shall supply, at its cost, Catalent with
sufficient quantities of Client-supplied Materials in order for Catalent to
complete such reprocessing or replacing.
ARTICLE 6
DELIVERY
6.1 Delivery. Catalent shall pack, label and deliver Product Ex Works (Incoterms
2010) the Facility promptly following Catalent’s release of Product in
accordance with Applicable Laws and Catalent’s standard procedures. Catalent
shall segregate and store all Product until tender of delivery. Title to Product
shall transfer to Client upon Catalent’s tender of delivery. Client shall
qualify at least 1 carriers to ship Product and then designate the priority of
such qualified carriers to Catalent.
6.2 Storage Fees. If Client fails to take delivery of any Product on any
scheduled delivery date, Catalent shall store such Product and have the right to
invoice Client monthly following such scheduled delivery for reasonable
administration and storage costs.
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6.3 Bill and Hold. From time to time, at the Client’s request, the agreed
delivery date of the Purchase Order may be extended under a bill and hold
arrangement as more fully set forth below. For each such Batch of stored
Product, Client agrees that: (A) Client has made a fixed commitment to purchase
the Product, (B) risk of loss for such Product passes to Client upon placement
into storage, (C) such Product shall be on a bill and hold basis for legitimate
business purposes, (D) the Client shall identify a fixed delivery date for the
Product and (E) Client agree to be invoiced and to pay such invoice in
accordance with the Payment terms set forth in this Agreement. Upon making a
request for a bill and hold arrangement, Client shall provide Catalent with a
letter confirming items (A) through (E) of this Section for each Batch of stored
Product.

6.4
ARTICLE 7
PAYMENTS
7.1 Fees. In consideration for Catalent performing services hereunder:
A.Client shall pay to Catalent the fees for Validation Services set forth on
Attachment A. Catalent shall submit an invoice to Client for such fees upon the
completion of the relevant phase of the Validation Services.
B.Client shall pay Catalent the unit pricing for Product set forth on Attachment
C (together with any subsequent updates to pricing, the “Unit Pricing”).
Catalent shall submit an invoice to Client for such fees upon tender of delivery
of Product as provided in Section 6.1.
C.Client shall pay Catalent the annual fees for Product Maintenance Services set
forth on Attachment D. Catalent shall submit an invoice to Client for such fees
upon the Effective Date and upon each anniversary of the Effective Date during
the Term.
D.Other Fees. Client shall pay Catalent for all other fees and expenses of
Catalent owing in accordance with the terms of this Agreement, including
pursuant to Sections 2.4, 4.1, 6.2 and 16.3, and Attachment D. Catalent shall
submit an invoice to Client for such fees as and when appropriate.
7.2 Unit Pricing Increase. The Unit Pricing shall be adjusted on an annual
basis, effective on each anniversary date of the Effective Date, upon 90 days’
prior written notice from Catalent to Client, to reflect increases or decreases
in, among other things, labor, utilities and overhead and shall be in an amount
equal to the increase in the Producers Output Pricing Index (“POPI”) as defined
in tables MM22 under category K3BI, as published on www.ons.gov.uk; provided,
however, that no increase or decrease in Unit Pricing shall be made to the
portion of Unit Pricing that represents royalties under the Development
Agreement. In addition, in the event there are proposed price increases for Raw
Materials, labor, utilities and components in excess of POPI, the parties shall
use commercially reasonable efforts to minimize such price increases and
Catalent shall pass such price increases through to Client, without mark-up, at
the time of such price increase through an adjustment to the Unit Pricing.
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7.3 Product Approval. If any Regulatory Approval necessary for Catalent to
commence Processing at the Facility has not been obtained by Client within 12
months following the Effective Date, then Client shall pay to Catalent a fee as
provided in Attachment C (“Delayed Approval Fee”) until such Regulatory Approval
has been obtained and Catalent is able to commence Processing.
7.4 Payment Terms. Payment of all Catalent invoices shall be due 30 days after
the date of invoice. Client shall make payment in U.S. dollars, and otherwise as
directed in the applicable invoice. If any payment is not received by Catalent
by its due date, then Catalent may, in addition to other remedies available at
equity or in law, charge interest on the outstanding sum from the due date (both
before and after any judgment) at 2% per month until paid in full (or, if less,
the maximum amount permitted by Applicable Laws).
7.5 Advance Payment. Notwithstanding any other provision of this Agreement to
the contrary, if at any time Catalent determines that Client’s credit is
impaired, Catalent may require payment in advance before performing any further
service under this Agreement, including any Processing, or making any further
shipment of Product. If Client shall fail, within a reasonable time, to make
such payment in advance, or if Client shall fail to make any payment when due,
Catalent shall have the right, at its option, to suspend any further performance
under this Agreement until such default is corrected, without such suspension
releasing Client from its obligations under this Agreement.
7.6 Taxes. All taxes, duties and other amounts (excluding taxes based on net
income and franchise taxes) assessed in respect of Client-supplied Materials,
services or Product prior to or upon provision or sale, as the case may be,
whether assessed on Catalent or Client, are the responsibility of Client, and
either Client shall reimburse Catalent for all such taxes, duties or other
amounts paid by Catalent or such sums will be added to invoices directed at
Client. If any deduction or withholding in respect of tax or otherwise is
required by law to be made from any of the sums payable hereunder, Client shall
be obliged to pay to Catalent such greater sum as will leave Catalent, after
deduction or withholding as is required to be made, with the same amount as it
would have been entitled to receive in the absence of any such requirement to
make a deduction or withholding.
7.7 Client and Third Party Expenses. Except as may be expressly covered by
Product Maintenance Service fees, Client shall be responsible for 100% of its
own and all third-party expenses associated with development, Regulatory
Approval and commercialization of Product, including regulatory filings and
post-approval marketing studies.
7.8 Development Batches. Each Batch produced under this Agreement, including
those necessary to support the validation portion of Client’s submissions for
Regulatory Approvals, will be considered to be a “development batch” unless and
until Processing has been validated. Client shall be responsible for the cost of
each such Batch, even if such Batch fails to meet the Specifications, unless
Catalent was grossly negligent in the Processing of the out-of-Specification
Batch. Catalent and Client shall cooperate in good faith to resolve any problem
causing the out-of-Specification Batch.
ARTICLE 8
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CHANGES TO SPECIFICATIONS
All Specifications and any change to the Specifications agreed by the parties
from time to time shall be in writing, dated and signed by the parties. Any
change to the Process shall be deemed a Specification change. No change in the
Specifications shall be implemented by Catalent, whether requested by Client or
requested or required by any Regulatory Authority, until the parties have agreed
in writing to such change, the implementation date of such change, and any
increase or decrease in costs, expenses or fees associated with such change
(including any change to Unit Pricing). Catalent shall respond promptly to any
request made by Client for a change in the Specifications, and both parties
shall use commercially reasonable, good-faith efforts to agree to the terms of
such change in a timely manner. As soon as practicable after a request is made
for any change in Specifications, Catalent shall notify Client of the costs
associated with such change and shall provide such supporting documentation as
Client may reasonably require. Client shall pay all costs associated with agreed
changes to the Specifications. If there is a conflict between the terms of this
Agreement and the terms of the Specifications, this Agreement shall control.
Catalent reserves the right to postpone effecting changes to the Specifications
until such time as the parties agree to and execute the required written
amendment.
ARTICLE 9
RECORDS; REGULATORY MATTERS
9.1 Recordkeeping. Catalent shall maintain materially complete and accurate
Batch, laboratory data and other technical records relating to Processing in
accordance with Catalent standard operating procedures. Such information shall
be maintained for a period of at least 2 years from the relevant finished
Product expiration date or longer if required under Applicable Laws or the
Quality Agreement.
9.2 Regulatory Compliance. Catalent shall obtain and maintain all permits and
licenses with respect to general Facility operations required by any Regulatory
Authority in the jurisdiction in which Catalent Processes Product. Client shall
obtain and maintain all other Regulatory Approvals, authorizations and
certificates with respect to Product or the services provided pursuant to this
Agreement, including those necessary for Catalent to commence Processing.  
Client shall not identify Catalent in any regulatory filing or submission
without Catalent’s prior written consent, which consent shall not be
unreasonably withheld and shall be memorialized in a writing signed by
authorized Representatives of both Parties. Upon written request, Client shall
provide Catalent with a copy of each Regulatory Approval required to distribute,
market or sell Product in the Territory. If Client is unable to provide such
information, Catalent shall have no obligation to deliver Product to Client,
notwithstanding anything to the contrary in this Agreement. During the Term,
Catalent will assist Client with all regulatory matters relating to Processing,
at Client’s request and expense. The parties intend and commit to cooperate to
allow each party to satisfy its obligations under Applicable Laws relating to
Processing under this Agreement.
9.3 Governmental Inspections and Requests. Catalent shall promptly advise Client
if an authorized agent of any Regulatory Authority notifies Catalent that the
agent intends to or does visit the Facility where at least one purpose relates
to Processing. Upon request, Catalent shall
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provide Client with a copy of any report issued by such Regulatory Authority
received by Catalent following such visit, redacted as appropriate to protect
any confidential information of Catalent or Catalent’s other customers. Client
acknowledges that it may not direct the manner in which Catalent fulfills its
obligations to permit inspection by and to communicate with Regulatory
Authorities. Client shall reimburse Catalent for all reasonable and documented
costs associated with inspections by Regulatory Authorities in connection with
Product, and pay the fees specified in Attachment D, to the extent applicable.
9.4 Client Facility Audits. During the Term, Client’s Representatives shall be
granted access upon at least 10 business days’ prior notice, at reasonable times
during regular business hours, to (A) the portion of the Facility where Catalent
performs Processing, (B) relevant personnel involved in Processing and (C)
Processing records described in Section 9.2, in each case solely for the purpose
of verifying that Catalent is Processing in accordance with cGMPs, the
Specifications and the Product master Batch records. Client may not conduct an
audit under this Section 9.4 more than once during any 12-month period;
provided, that additional inspections may be conducted in the event there is a
material quality or compliance issue concerning Product or its Processing.
Client’s Quality Assurance Manager will arrange Client audits with Catalent
Quality Management. Audits and inspections under this Section 9.4 shall be
designed to minimize disruption of operations at the Facility. Such
Representatives shall abide by all Catalent safety rules and other applicable
employee policies and procedures, and Client shall be responsible for such
compliance. Client shall indemnify and hold harmless Catalent for any action,
omission or other activity of its Representatives while on Catalent’s premises.
Client’s Representatives shall be required to sign Catalent’s standard visitor
confidentiality agreement prior to being allowed access to the Facility.
9.5 Recall. If a Regulatory Authority orders or requires the recall of any
Product supplied pursuant to this Agreement or if Catalent believes a recall,
field alert, Product withdrawal or field correction (“Recall”) may be necessary
with respect to any Product supplied under this Agreement, the party receiving
the notice from the Regulatory Authority or that holds such belief shall
promptly notify the other party in writing. Catalent will not act to initiate a
Recall without the express prior written approval of Client, unless otherwise
required by Applicable Laws. If Client believes a Recall may be necessary with
respect to any Product supplied under this Agreement, Client shall promptly
notify Catalent and Catalent shall provide all necessary cooperation and
assistance to Client. Client shall provide Catalent with an advance copy of any
proposed submission to a Regulatory Authority in respect of any Recall, and
shall consider in good faith any comment from Catalent. The cost of any Recall
shall be borne by Client, and Client shall reimburse Catalent for expenses
incurred in connection with any Recall, in each case unless such Recall is
caused solely by Catalent’s breach of its obligations under this Agreement,
violation of Applicable Laws or its negligence or willful misconduct, in which
case Catalent shall bear the reasonable, actual and documented administrative
costs incurred by Client for such Recall and, if applicable, the cost of
replacing Product subject to Recall, both to the extent and as provided in
Article 5.
9.6 Quality Agreement. Within 6 months after the Effective Date, and in any
event prior to the first Processing of Product under this Agreement, the parties
shall negotiate in good faith and enter into a quality agreement on Catalent’s
standard template (the “Quality Agreement”). The
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Quality Agreement shall in no way determine liability or financial
responsibility of the parties for the responsibilities set forth in that
agreement. In the event of a conflict between any provision of this Agreement
and the Quality Agreement with respect to quality-related activities, including
compliance with cGMP, the provisions of the Quality Agreement shall govern. In
the event of a conflict between any provision of this Agreement and the Quality
Agreement with respect to any commercial matter, including allocation of risk,
liability and financial responsibility, the provisions of this Agreement shall
govern.
9.7 Regulatory Authority Fees. Catalent reserves the right to assess Client for
any Regulatory Authority fees that may be established by any regulatory
authority, which fees result directly from Catalent’s formulation, development,
manufacturing, processing, filling, packaging, storing or testing of Client’s
product or Client-supplied materials. Without limiting the foregoing, Client
shall reimburse Catalent for any Regulatory Authority fees Catalent may be
required to pay pursuant to the Generic Drug User Fee Amendments of 2017,
(“GDUFA Fees”), where such fees result directly from Catalent’s formulation,
development, manufacturing, processing, filling, packaging, storing or testing
of Client’s product or Client-supplied materials. A Catalent facility incurs
GDUFA Fees when that Catalent facility is referenced in an approved ANDA. GDUFA
Fees are assessed by the FDA on October 1st of each year and shall be paid by
Client annually, where applicable. On or after October 1st of each year,
Catalent will invoice Client for Client’s pro-rata share of the annual GDUFA Fee
Catalent incurs for each Catalent manufacturing or packaging facility identified
in Client’s approved ANDA(s). This includes, but is not limited to, any Catalent
facility which manufactured or packaged Client’s registration batches. Catalent
will invoice Client for reimbursement of all other payments or fees at the time
they are incurred by Catalent. Client shall pay all such invoices within 30 days
from the date of such invoice.
ARTICLE 10
CONFIDENTIALITY AND NON-USE
10.1 Definition. As used in this Agreement, the term “Confidential Information”
means all confidential information of the disclosing person of whatever type,
including all information furnished by or on behalf of Catalent or Client (as
the case may be, “Discloser”), its Affiliates or any of its or their respective
Representatives, to the other party (for purposes of this Article 10,
“Recipient”), its Affiliates or any of its or their respective Representatives,
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 Confidential
Information furnished by Discloser, its Affiliates or any of its or their
respective Representatives. Confidential Information also includes the existence
and terms of this Agreement.
10.2 Exclusions. Notwithstanding anything in Section 10.1 to the contrary,
Confidential Information does not include information that (A) is or becomes
generally available to the public
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or within the industry to which such information relates other than as a result
of a breach of this Agreement, (B) is already known by Recipient at the time of
disclosure as evidenced by Recipient’s written records, (C) becomes available to
Recipient on a non-confidential basis from a source that is entitled to disclose
it on a non-confidential basis or (D) was or is independently developed by or
for Recipient without reference to Discloser’s Confidential Information as
evidenced by Recipient’s written records.
10.3 Mutual Obligation. Recipient A) will keep confidential all Confidential
Information, employing such protections as it would use for its own Confidential
Information of a similar type but in no case less than reasonable protections
under the circumstances, (B) will not use Discloser’s Confidential Information
except in connection with the performance of its obligations under this
Agreement, and (C)will not disclose to any third party, without Discloser’s
prior written consent, Discloser’s Confidential Information, except that
Recipient may disclose Discloser’s Confidential Information to any of its
Affiliates and its or their respective Representatives that (I) need to know
such Confidential Information for the purpose of performing under this
Agreement, (II) are advised of the contents of this Article and (III) are bound
to Recipient by obligations of confidentiality at least as restrictive as the
terms of this Article. Each party shall be responsible for any breach of this
Article by its Affiliates or any of its or their respective Representatives.
10.4 Permitted Disclosure. Recipient may disclose Discloser’s Confidential
Information to the extent required by law or regulation; provided, that prior to
making any such legally required disclosure, Recipient shall give Discloser as
much prior notice of the requirement for and contents of such disclosure as is
practicable under the circumstances. Any such disclosure, however, shall not
relieve Recipient of its obligations under this Agreement.
10.5 No Implied License. Except as expressly set forth in Section 10.1,
Recipient will obtain no right of any kind or license under any of Discloser’s
Confidential Information, including any patent application or patent, by reason
of this Agreement. Discloser’s Confidential Information will remain Discloser’s
sole property, subject to Article 11.
10.6 Return of Confidential Information. Upon expiration or termination of this
Agreement, Recipient will (and will cause its Affiliates and its and their
respective Representatives to) cease its use and, upon written request, within
30 days either return or destroy (and certify as to such destruction) all of
Discloser’s Confidential Information, including any copy of such information,
except for a single copy which may be retained for the sole purpose of ensuring
compliance with its obligations under this Agreement.
10.7 Survival. The obligations of this Article will terminate 5 years from the
expiration or termination of this Agreement, except with respect to trade
secrets, for which the obligations of this Article will continue for so long as
such information remains a trade secret under law.
ARTICLE 11
INTELLECTUAL PROPERTY
11.1 As used in this Agreement, “Client IP” means all intellectual property and
related embodiments owned by or licensed to Client as of the Effective Date or
developed by Client
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other than in connection with this Agreement; “Catalent IP” means all
intellectual property and related embodiments owned by or licensed to Catalent
as of the Effective Date or developed by Catalent other than in connection with
this Agreement; “Invention” means any intellectual property developed by either
party or jointly by the parties in connection with this Agreement; “API
Inventions” means any Invention that relates exclusively to the Client IP,
Client’s patented API or Client’s proprietary Zydis® formulation of the API; and
“Process Inventions” means any Invention, other than an API Invention, that
relates exclusively to Catalent IP, Catalent’s Confidential Information,
improvements to the Zydis® Technology, Catalent’s manufacturing processes or
that relates to developing, formulating, manufacturing, filling, processing,
packaging, analyzing or testing pharmaceutical products generally. All Client IP
and API Inventions shall be owned solely by Client and no right therein is
granted to Catalent under this Agreement, except that Catalent shall have a
non-exclusive, royalty-free license to such items solely to the extent necessary
to perform its obligations under this Agreement. All Catalent IP and Process
Inventions shall be owned solely by Catalent and no right therein is granted to
Client under this Agreement. The parties shall cooperate to achieve the
allocation of rights to Inventions set forth in this Article 11, and each party
shall be solely responsible for costs associated with the protection of its
intellectual property. For avoidance of doubt, this Article 11 is intended to be
in addition to, and not in lieu of, provisions regarding the allocation of
rights in intellectual property set forth in the Development Agreement. In
particular, this Article 11 shall not affect or impair Article 5 of the
Development Agreement. In the event of a conflict between this Article 11 and
Article 5 of the Development Agreement, Article 5 of the Development Agreement
shall control.

ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1 Catalent. Catalent represents, warrants and undertakes to Client that:
A.At the time of delivery by Catalent as provided in Section 6.1, Product shall
have been Processed in accordance with Applicable Laws and cGMP and the Product
shall be in conformity with the applicable Specifications and the Quality
Agreement and shall not have been adulterated, misbranded or mislabeled within
the meaning of Applicable Laws and cGMP; provided, that Catalent shall not be
liable for defects attributable to Client-supplied Materials (including artwork,
advertising and labeling);
B.To its knowledge, there are no patents owned by any Third Parties related to
the Zydis Technology that are not owned by, or licensed to, Catalent or its
Affiliates, that would be infringed or misused by Catalent’s performance under
this Agreement; and, to its knowledge, no trade secret, trademark, trade name,
copyright or other proprietary rights of any Third Party would be infringed or
misused by Catalent’s performance of this Agreement; provided, however, that
Catalent’s representation under this Section 12.1 (B) shall not extend to
activities conducted by Catalent due to Client’s exercise of control over the
Processing;
C  it will not in the performance of its obligations under this Agreement use
the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b);
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D Catalent will deliver Product to Client with unencumbered title;
E The Facility and its operation in Processing shall be in compliance with
Applicable Laws, including health, safety and environmental permits and
Regulatory Approvals, necessary for the operation of the Facility or conduct of
the Processing;
F Catalent has not employed and does not employ, and will promptly take
appropriate disciplinary actions against and immediately remove from any
service, any individual who is or becomes debarred under 21 U.S.C. § 335(a) or
(b) or any comparable provision of any other Applicable Laws, and will provide,
upon request by Client, a certification that it has not employed and does not
employ, and will promptly take appropriate disciplinary actions against and
immediately cease using any such individual in the provision of any services
under this Agreement; and
G Catalent has the right to use the Zydis Technology in the activities conducted
by it in the performance of this Agreement.

12.2 Client. Client represents, warrants and undertakes to Catalent that:
A.[***];
B.The content of all artwork provided by or on behalf of Client to Catalent
shall comply with all Applicable Laws;
C.All Product delivered to Client by Catalent shall be held, used and disposed
of by or on behalf of the Client in accordance with all Applicable Laws, and
Client will otherwise comply with Applicable Laws relating to Client’s
performance under this Agreement;
D.Client will not release any Batch of Product if the required certificates of
conformance indicate that Product does not comply with the Specifications or if
Client does not hold all necessary Regulatory Approvals to market and sell the
Product;
E.Client has the right to permit Catalent to use in Catalent’s performance of
this Agreement all Client IP related to the Product, Client-supplied Materials
(including artwork) or the Processing of Product and Client-supplied Materials;
to its knowledge, there is no patent owned by a Third Party related to the
Client IP used to Process Product that would be infringed or misused by
Catalent’s performance under this Agreement; and, to its knowledge, no trade
secret trademark, trade name, copyright or other proprietary right of any Third
Party would be infringed or misused by Catalent’s performance under this
Agreement; provided, however, that Client’s representation under this Section
12.2 (E) shall not extend to activities conducted by Catalent except to the
extent due to Client’s exercise of control over the Processing; and
F.Client will supply Client-supplied Materials to Catalent with unencumbered
title.
12.3 Mutual Representation. Furthermore, Catalent and Client both represent,
warrant and undertake that no transaction or dealing under this Agreement shall
be conducted with or for an
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individual or entity that is designated as the target of any sanction,
restriction or embargo administered by the United Nations, European Union,
United Kingdom, or United States.
12.4 Limitations. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE
ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO
THE OTHER PARTY, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATION, WARRANTY OR
GUARANTEE OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 13
INDEMNIFICATION
13.1 Indemnification by Catalent. Catalent shall indemnify, defend and hold
harmless Client, its Affiliates, and their respective directors, officers,
employees and agents (collectively, “Client Indemnitees”) from and against any
and all suits, claims, losses, demands, liabilities, damages, costs and expenses
(including reasonable attorneys’ fees and expenses and reasonable investigative
costs) in connection with any suit, demand or action by any third party
(“Losses”) arising out of, relating to or resulting from (A) any breach of its
representations, warranties or obligations set forth in this Agreement; (B) any
negligence or willful misconduct by Catalent; or (C) any actual or alleged
infringement or violation of any Third Party patent, trade secret, copyright,
trademark or other proprietary right by the Zydis Technology; in each case
except to the extent that any of the foregoing arises out of or results from any
Client Indemnitee’s negligence, willful misconduct or breach of this Agreement.
13.2 Indemnification by Client. Client shall indemnify, defend and hold harmless
Catalent, its Affiliates, and their respective directors, officers, employees
and agents (collectively, “Catalent Indemnitees”) from and against any and all
Losses arising out of, relating to or resulting from (A) any breach of its
representations, warranties or obligations set forth in this Agreement, (B) any
manufacture, packaging, sale, promotion, distribution or use of or exposure to
Product or Client-supplied Materials, including product liability or strict
liability, (C) Client’s exercise of control over the Processing to the extent
that Client’s instructions or directions violate Applicable Laws, (D) the
conduct of any clinical trial utilizing Product or API, (E) any actual or
alleged infringement or violation of any Third Party patent, trade secret,
copyright, trademark or other proprietary right by intellectual property or
other information provided by Client, including Client-supplied Materials, or
(F) any negligence or willful misconduct by Client; in each case except to the
extent that any of the foregoing arises out of or results from any Catalent
Indemnitee’s negligence, willful misconduct or breach of this Agreement. In
addition, Client shall indemnify and hold harmless the Catalent Indemnitees from
and against any and all Losses arising out of or resulting from any federal
regulatory filings by or on behalf of Client or any of its Affiliates, including
Losses incurred by Catalent arising from filings under 21 U.S.C. 355 and/or
Section 505 of the Food and Drug Act (or non-U.S. equivalents) and related
claims or proceedings (including Losses associated with Catalent’s obligation to
respond to third party subpoenas).
13.3 Indemnification Procedures. All indemnification obligations in this
Agreement are conditioned upon the indemnified party (A) promptly notifying the
indemnifying party of any
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claim or liability of which the indemnified party becomes aware (including a
copy of any related complaint, summons, notice or other instrument); provided,
however, that failure to provide such notice within a reasonable period shall
not relieve the indemnifying party of its obligations under this Article 13
except to the extent, if any, the indemnifying party is prejudiced by such
failure, (B) allowing the indemnifying party, if the indemnifying party so
requests, to conduct and control the defense of any such claim or liability and
any related settlement negotiations (at the indemnifying party’s expense),
provided, that the indemnifying party shall promptly provide and continuously
maintain such defense (C) cooperating with the indemnifying party in the defense
of any such claim or liability and any related settlement negotiations (at the
indemnifying party’s expense) and (D) not compromising or settling any claim or
liability without prior written consent of the indemnifying party.
ARTICLE 14
LIMITATIONS OF LIABILITY
14.1 CATALENT SHALL HAVE NO LIABILITY UNDER THIS AGREEMENT FOR ANY AND ALL
CLAIMS FOR LOST, DAMAGED OR DESTROYED CLIENT-SUPPLIED MATERIALS, WHETHER OR NOT
SUCH CLIENT-SUPPLIED MATERIALS ARE INCORPORATED INTO PRODUCT.
14.2 EXCEPT FOR CATALENT’S BREACH OF THE TERMS OF THIS AGREEMENT FOR WILLFUL
MISCONDUCT OR GROSS NEGLIGENCE AND CATALENT’S INDEMNIFICATION OBLIGATIONS UNDER
ARTICLE 13 FOR THIRD PARTY DEATH OR BODILY HARM, CATALENT’S TOTAL LIABILITY
UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED [***].
14.3 NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL,
SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF REVENUES, PROFITS OR DATA
ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, WHETHER IN CONTRACT OR IN TORT,
EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
ARTICLE 15
INSURANCE
Each party shall, at its own cost and expense, obtain and maintain in full force
and effect during the Term the following: (A) Commercial General Liability
insurance with a per-occurrence limit of not less than [***]; (B) Products and
Completed Operations Liability insurance with a per-occurrence limit of not less
than [***]; (C) Workers’ Compensation insurance with statutory limits and
Employers Liability insurance with limits of not less than [***] per accident;
and (D) All Risk Property insurance, including transit coverage, in an amount
equal to the full replacement value of its property while in, or in transit to,
the Facility as required under this Agreement. 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 its annual EBITDA (earnings
before interest, taxes, depreciation and amortization) is greater than [***].
Each required insurance policy, other than self-insurance, shall be obtained
from an insurance carrier with an A.M. Best rating of at least A- VII. If any
required insurance policy is written on a
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claims-made basis, such policy shall be maintained throughout the Term and for a
period of at least 3 years thereafter. Each party shall obtain a waiver of
subrogation clause from its property insurance carriers in favor of the other
party. Each party shall be named as an additional insured within the other
party’s products liability insurance policies; provided, that such additional
insured status will apply solely to the extent of the insured party’s indemnity
obligations under this Agreement. Such 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 or
qualification to self-insurance in accordance with the requirements of this
Article 15.
ARTICLE 16
TERM AND TERMINATION
16.1 Term. This Agreement shall commence on the Effective Date and shall
continue until the later of (i) the expiration or termination of the Development
Agreement or (ii) [***] from the commercial Launch of the Product in the
Territory, unless earlier terminated in accordance with Section 16.2 (such term,
including any extension in accordance with this Section 16.1, the “Term”).
Unless this Agreement is terminated in accordance with Section 16.2, the Term
shall automatically extend for successive 2-year periods unless and until one
party gives the other party at least 12 months’ prior written notice of its
desire to terminate as of the end of the then-current Term.
16.2 Termination. This Agreement may be terminated immediately without further
action:
A.by either party if the other party files a petition in bankruptcy, or enters
into an agreement with its creditors, or applies for or consents to the
appointment of a receiver, administrative receiver, trustee or administrator, or
makes an assignment for the benefit of creditors, or suffers or permits the
entry of any order adjudicating it to be bankrupt or insolvent and such order is
not discharged within 30 days, or takes any equivalent or similar action in
consequence of debt in any jurisdiction; or
B.by either party if the other party materially breaches this Agreement and such
breach is not cured within 60 days after the giving of written notice requiring
the breach to be remedied; provided, that in the case of a failure of Client to
make payments in accordance with the terms of this Agreement, Catalent may
terminate this Agreement if such payment breach is not cured within 10 days of
receipt of notice of non-payment from Catalent.
16.3 Effect of Termination. Expiration or termination of this Agreement shall be
without prejudice to any right or obligation that accrued to the benefit of
either party prior to such expiration or termination. In the event of a
termination of this Agreement:
A.Catalent shall promptly return to Client, at Client’s expense and direction,
any remaining inventory of Product or Client-supplied Materials; provided, that
all outstanding invoices have been paid in full;
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B.Client shall pay Catalent all invoiced amounts outstanding hereunder, plus,
upon receipt of invoice therefor, for any (i) Product that has been shipped
pursuant to Purchase Orders but not yet invoiced, (ii) Product Processed
pursuant to Purchase Orders that has been completed but not yet shipped, and
(iii) in the event that this Agreement is terminated for any reason other than
by Client pursuant to Section 16.2(A) or (B), all Product being Processed
pursuant to Purchase Orders (or, alternatively, Client may instruct Catalent to
complete such work in process, and the resulting completed Product shall be
governed by clause (ii));
C.in the event that this Agreement is terminated for any reason other than by
Client pursuant to Section 16.2(A) or (B), Client shall pay Catalent for all
costs and expenses incurred, and all noncancellable commitments made, in
connection with Catalent’s performance of this Agreement, so long as such costs,
expenses or commitments were made by Catalent consistent with Client’s most
recent Firm Commitment and the vendor’s minimum purchase obligations.
16.4 Survival. The rights and obligations of the parties shall continue under
Articles 11 (Intellectual Property), 13 (Indemnification), 14 (Limitations of
Liability), 17 (Notice), 18 (Miscellaneous); under Articles 10 (Confidentiality
and Non-Use) and 15 (Insurance), in each case to the extent expressly stated
therein; and under Sections 7.4 (Payment Terms), 7.6 (Taxes), 7.7 (Client and
Third Party Expenses), 9.1 (Recordkeeping), 9.5 (Recall), 12.4 (Limitations),
16.3 (Effect of Termination) and 16.4 (Survival), in each case in accordance
with their respective terms if applicable, notwithstanding expiration or
termination of this Agreement.
ARTICLE 17
NOTICE
All notices and other communications under this Agreement shall be in writing
and shall be deemed given: (A) when delivered personally or by hand; (B) when
delivered by electronic mail (e-mail); (C) when delivered by facsimile
transmission (receipt verified); (D) when received or refused, if sent by
registered or certified mail (return receipt requested), postage prepaid; or (E)
when delivered, if sent by express courier service; in each case to the parties
at the following addresses (or at such other address for a party as shall be
specified by like notice; provided, that notices of a change of address shall be
effective only upon receipt thereof):

To Client:    Biohaven Pharmaceuticals, Inc.
            234 Church Street, Suite 301
            New Haven, CT 06510 USA
Attn: Robert Berman, M.D. Chief Medical Officer
email: robert.berman@biohavenpharma.com

With a copy to:   IPraxus Legal, LLC
            67 Sterling Hill Road
            P.O. Box 689
            Lyme, CT 06371 US
            Attn: Warren K. Volles
            Email: mail@ipraxuslegal.com

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To Catalent:    Catalent U.K. Swindon Zydis Limited
Frankland Road
Blagrove
Swindon
Wiltshire SN5 8RU
United Kingdom
Attn: VP/GM Modified Release Technologies
Facsimile: +44 1793 886998]

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

ARTICLE 18
MISCELLANEOUS
18.1 Entire Agreement; Amendments. This Agreement, together with the Quality
Agreement and the Development Agreement, constitutes the entire understanding
between the parties, and supersedes any contract, agreement or understanding
(oral or written) of the parties, with respect to its subject matter. For the
avoidance of doubt, this Agreement does not supersede any existing generally
applicable confidentiality agreement between the parties as it relates to
periods prior to the Effective Date or to business dealings not covered by this
Agreement. No term of this Agreement may be amended except upon written
agreement of both parties, unless otherwise expressly provided in this
Agreement.
18.2 Captions; Certain Conventions. The captions in this Agreement are for
convenience only and are not to be interpreted or construed as a substantive
part of this Agreement. Unless otherwise expressly provided in this Agreement or
the context of this Agreement otherwise requires, (A) words of any gender
include each other gender, (B) words such as “herein”, “hereof”, and “hereunder”
refer to this Agreement as a whole and not merely to the particular provision in
which such words appear, (C) words using the singular include the plural, and
vice versa, (D) the words “include(s)” and “including” shall be deemed to be
followed by the phrase “but not limited to”, “without limitation” or words of
similar import, (E) the word “or” shall be deemed to include the word “and”
(e.g., “and/or”), (F) references to “Article,” “Section,” “subsection,” “clause”
or other subdivision, or to an Attachment or other appendix, without reference
to a document are to the specified provision or Attachment of this Agreement,
and (G) subject to Applicable Laws, all references to liabilities or obligations
of Catalent shall be subject to Article 14, regardless of whether the particular
provision includes a cross-reference to Article 14. This Agreement shall be
construed as if it were drafted jointly by the parties.
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18.3 Further Assurances. The parties shall execute, acknowledge and deliver such
further instruments and take all such other incidental acts as may be reasonably
necessary or appropriate to carry out the purpose and intent of this Agreement.
18.4 No Waiver. Failure by either party to insist upon strict compliance with
any term of this Agreement in any one or more instances will not be deemed a
waiver of its rights to insist upon such strict compliance with respect to any
subsequent failure.
18.5 Severability. If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining
terms of this Agreement will continue in full force and effect.
18.6 Independent Contractors. The relationship of the parties is that of
independent contractors, and neither party will incur any debt or make any
commitment for the other party except to the extent expressly provided in this
Agreement. Nothing in this Agreement is intended to create or will be construed
as creating between the parties the relationship of joint venturers,
co-partners, employer/employee or principal and agent. Neither party shall have
any responsibility for the hiring, termination or compensation of the other
party’s employees or contractors or for any employee benefits of any such
employee or contractor.
18.7 Successors and Assigns. This Agreement will be binding upon and inure to
the benefit of the parties, their successors and permitted assigns. Neither
party may assign this Agreement, in whole or in part, without the prior written
consent of the other party, except that either party may, without the other
party’s consent (but subject to prior written notice), assign its rights and
delegate its duties under this Agreement to an Affiliate (and in the case of
Client, to a Collaborator, upon Catalent’s written consent, which shall not be
unreasonably withheld) or to a successor that acquires (through the purchase of
assets, stock or otherwise) substantially all of the business or assets of the
assigning party to which this Agreement relates and any assignment in violation
of this Section 18.7 shall be void ab initio.
18.8 No Third Party Beneficiaries. This Agreement shall not confer any right or
remedy upon any individual or entity other than the parties and their respective
successors and permitted assigns, except that the Client Indemnitees and the
Catalent Indemnitees may invoke the benefits of the indemnification provisions
of this Agreement.
18.9 Governing Law. This Agreement shall be governed by and construed under the
laws of the State of Delaware, USA, excluding its conflicts of law provisions.
The United Nations Convention on Contracts for the International Sale of Goods
shall not apply to this Agreement.
18.10 Alternative Dispute Resolution. Any dispute arising between the Parties in
connection with this Agreement shall first be presented to the respective senior
executives of the Parties for their consideration and resolution. If such
Parties’ executives cannot resolve such dispute within ninety (90) days, then
such dispute may submitted be either Party to arbitration by the International
Institute for Conflict Prevention and Resolution, 575 Lexington Avenue, 21st
Floor, New York, NY  10022 (“CPR”) by one arbitrator selected by the Parties. If
no agreement on an arbitrator can be reached within thirty (30) days after the
CPR offers names of potential arbitrators, then the CPR will choose one
arbitrator having reasonable experience in commercial
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transactions of the type described in this Agreement. The arbitration shall take
place in the English language in New York City, New York, in accordance with the
CPR administered arbitration rules then in effect, and judgment upon any award
rendered in such arbitration will be binding and may be entered in any court
having jurisdiction of the matter. The arbitration shall commence within sixty
(60) days of the date on which a written demand for arbitration is filed. The
arbitrator’s decision shall set forth a reasoned basis for any award of damages
or finding of liability. The arbitrator shall not have power to award damages in
excess of actual compensatory damages and shall not multiply actual damages or
award punitive damages. The arbitrator shall award to the prevailing party, if
any, its costs and attorneys’ fees and expenses reasonably incurred in
connection with the arbitration, including any subsequent or related enforcement
proceeding.
18.11 Prevailing Party. In any dispute resolution proceeding between the parties
in connection with this Agreement, the prevailing party will be entitled to
recover its reasonable attorney’s fees and costs in such proceeding from the
other party.
18.12 Publicity. Neither party will make any press release or other public
disclosure regarding this Agreement or the transactions contemplated hereby
without the other party’s express prior written consent, except as required
under Applicable Laws, by any governmental agency or by the rules of any stock
exchange on which the securities of the disclosing party are listed, in which
case the party required to make the press release or public disclosure shall use
commercially reasonable efforts to obtain the approval of the other party as to
the form, nature and extent of the press release or public disclosure prior to
issuing the press release or making the public disclosure.
18.13 Right to Dispose and Settle. If Catalent requests in writing from Client
direction with respect to disposal of any inventories of Product,
Client-supplied Materials, equipment, samples or other items belonging to Client
and is unable to obtain a response from Client within a reasonable period after
making reasonable efforts to do so, Catalent shall be entitled in its sole
discretion to (A) dispose of all such items and (B) set-off any and all amounts
due to Catalent or any of its Affiliates from Client against any credits Client
may hold with Catalent or any of its Affiliates.
18.14 Force Majeure. Except as to payments required under this Agreement,
neither party shall be liable in damages for, nor shall this Agreement be
terminable or cancelable by reason of, any delay or default in such party’s
performance hereunder if such default or delay is caused by events beyond such
party’s reasonable control, including acts of God, law or regulation or other
action or failure to act of any government or agency thereof, war or
insurrection, civil commotion, destruction of production facilities or materials
by earthquake, fire, flood or weather, labor disturbances, epidemic or failure
of suppliers, vendors, public utilities or common carriers; provided, that the
party seeking relief under this Section 18.14 shall promptly notify the other
party of such cause(s) beyond such party’s reasonable control. The party that
may invoke this Section 18.14 shall use commercially reasonable efforts to
reinstate its ongoing obligations to the other party as soon as practicable. If
the cause(s) shall continue unabated for 180 days, then both parties shall meet
to discuss and negotiate in good faith what modifications to this Agreement
should result from such cause(s).
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18.15 Counterparts. This Agreement may be executed in one or more counterparts,
each of which will be deemed an original but all of which together will
constitute one and the same instrument. Any photocopy, facsimile or electronic
reproduction of the executed Agreement shall constitute an original.
[Signature page follows]

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IN WITNESS WHEREOF, the parties have caused their respective duly authorized
representatives to execute this Agreement effective as of the Effective Date.

CATALENT U.K. SWINDON ZYDIS LIMITEDBy:/s/ Peter AllenName: Peter AllenTitle:
General ManagerBiohaven Pharmaceuticals, Inc.By:/s/ Vlad CoricName: Vlad
CoricTitle: CEO and Director

Signature Page to Zydis® Commercial Supply Agreement