Exhibit 10.3

AMENDED AND RESTATED
TRANSITION SERVICES AGREEMENT
by and between

Eisai Inc.
and
AkaRx, Inc.

Dated as of April 1, 2018

    

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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TABLE OF CONTENTS
 
 
 
Page

ARTICLE 1   DEFINITIONS
 
 
1

1.1      Certain Defined Terms
 
 
1

1.2      Additional Defined Terms
 
 
3

1.3      Interpretation
 
 
2

ARTICLE 2   SERVICES
 
 
2

2.1      Provision of Services
 
 
2

2.2      Services Performed by Affiliates and Third Parties
 
 
3

2.3      Pass-Through Agreements
 
 
4

2.4      Services Standard; FTEs
 
 
4

2.5      Ongoing Trials; Drug Approval Applications
 
 
7

2.6      Assigned Contracts
 
 
8

2.7      Regulatory Services
 
 
8

2.8      Pharmacovigilance
 
 
10

2.9      Location of Services Provided; Travel Expenses
 
 
11

2.10    Transition Management
 
 
11

2.11    Cooperation
 
 
11

2.12    Documentation
 
 
12

2.13    Exclusions
 
 
12

2.14    Exclusion of Warranties
 
 
13

ARTICLE 3   COMPENSATION
 
 
13

3.1      Services Fees
 
 
13

3.2      Out-of-Pocket Costs
 
 
13

3.3      Invoicing
 
 
14

3.4      Excess Costs
 
 
14

3.5      Due Date
 
 
15

3.6      Taxes
 
 
15

3.7      Records; Audit
 
 
16

ARTICLE 4   OWNERSHIP OF ASSETS: INTELLECTUAL PROPERTY AND RIGHTS OF REFERENCE;
INVENTORY
 
 
16

4.1      Ownership
 
 
16

4.2      Limited License
 
 
18

4.3      Inventory
 
 
18

ARTICLE 5   CONFIDENTIALITY
 
 
18

5.1      Confidentiality Obligations
 
 
18

5.2      Permitted Uses and Disclosures
 
 
19

5.3      Return or Destruction of Confidential Information
 
 
20

5.4      Survival
 
 
20

ARTICLE 6   LIMITATION OF LIABILITY; INDEMNIFICATION
 
 
21

6.1      Other Agreements
 
 
21

6.2      Indemnification
 
 
21

6.3      Limitation of Liability
 
 
22

i
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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

ARTICLE 7   TERM AND TERMINATION
 
 
22

7.1      Term
 
 
22

7.2      Termination of Services
 
 
23

7.3      Asset Transfer
 
 
24

7.4      Accrued Rights
 
 
24

7.5      Surviving Obligations
 
 
24

ARTICLE 8   MISCELLANEOUS
 
 
24

8.1      Force Majeure
 
 
24

8.2      Independent Contractor
 
 
25

8.3      Assignment
 
 
25

8.4      No Benefit to Third Parties
 
 
25

8.5      Notices
 
 
25

8.6      Severability
 
 
26

8.7      Governing Law
 
 
27

8.8      Jurisdiction
 
 
27

8.9      Service of Process
 
 
27

8.10    Waiver of Jury Trial
 
 
27

8.11    Amendments and Waivers
 
 
27

8.12    Joint Drafting
 
 
28

8.13    Obligations
 
 
28

8.14    Counterparts
 
 
28

8.15    Entire Agreement
 
 
28

8.16    Dispute Resolution
 
 
28

SCHEDULES
Schedule 2.1        Initial Work Order
Schedule 2.2        Additional Work Order
Schedule 2.4.2        Key Employees for Services

EXHIBITS
Exhibit A        Pass-Through Agreements
Exhibit B        Form of Seller IND Transfer Letter
Exhibit C        Form of Company IND Transfer Letter

AMENDED AND RESTATED TRANSITION SERVICES AGREEMENT

This Amended and Restated Transition Services Agreement (this “Agreement”),
dated as of April 1, 2018 (the “Restated Effective Date”), by and between Eisai
Inc. a Delaware corporation (“Seller”), and AkaRx, Inc., a Delaware corporation
(the “Company”), which amends and restates the Transition Services Agreement,
dated as of March 30, 2016 (the “Effective Date”), as amended on March 30, 2016,
September 21, 2017, and March 16, 2018, by and between Seller and the Company
(collectively, the “Original Agreement”). Seller and the Company are sometimes
referred to herein individually as a “Party” and collectively as the “Parties”.
WHEREAS, Seller and PBM AKX Holdings, LLC, a Delaware limited liability company
(“Purchaser”) are parties to that certain Stock Purchase Agreement, dated as of
March 29, 2016 (the “Stock Purchase Agreement”), pursuant to which Purchaser
purchased from Seller the Shares (as defined in the Stock Purchase Agreement);
WHEREAS, as the sponsor of the Ongoing Trials (as defined in the Stock Purchase
Agreement), Seller has entered into the agreements listed in Exhibit A hereto
relating to the conduct of the Ongoing Trials (collectively, the “Pass-Through
Agreements”);
WHEREAS, following the consummation of the transactions contemplated by the
Stock Purchase Agreement, Seller and the Company entered into the Original
Agreement, pursuant to which Seller agreed to perform Initial Services (defined
below) for the benefit of Purchaser and the Company with respect to the
Company’s operation of the Company Business (as defined in the Stock Purchase
Agreement), subject to the terms and conditions contained in the Original
Agreement which the Parties acknowledge were negotiated on an arms’ length basis
by Purchaser (on behalf of the Company) and Seller; and
WHEREAS, the Parties have agreed to amend and restate the Original Agreement to,
among other things, add Additional Services (defined below) to the scope of the
Services (defined below) performed by Seller for the benefit of Purchaser and
the Company with respect to the Company’s operation of the Company Business,
subject to the terms and conditions contained herein.
NOW, THEREFORE, in consideration of the premises and the mutual promises and
conditions hereinafter set forth, and set forth in the Stock Purchase Agreement
and the other Ancillary Agreements (as defined in the Stock Purchase Agreement),
and other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties, intending to be legally bound, do hereby
agree as follows:

Article 1
DEFINITIONS

1.1    Certain Defined Terms    . Unless otherwise specifically provided herein,
capitalized terms used, but not otherwise defined, in this Agreement shall have
the meanings ascribed thereto in the Stock Purchase Agreement. As used herein,
the following capitalized terms have the following meanings.
“Accountant” means a nationally recognized independent accounting firm to be
mutually agreed upon by Seller and the Company.
“Affiliate” means, with respect to any Person, any Person controlling,
controlled by or under common control with such Person. For purposes of this
definition, “control” means, with respect to any entity, the possession,
directly or indirectly, of the power to direct or cause the direction of the
management and policies of such entity, whether through the ownership of voting
securities (or other ownership interest), by contract or otherwise.
“Applicable Laws” means the applicable provisions of any and all Laws,
Judgments, directives, and approvals of or from any Governmental Entity, as they
may be in effect from time to time, including the FDCA, Drug or Health Laws, and
Privacy Laws.
“Clinical Trial Materials” means materials used in the conduct of the Ongoing
Trials or otherwise in the performance of Clinical Trial Services, including the
Compound and Products packaged for use in the Ongoing Trials.
“Compound INDs” means Investigational New Drug Application #062122,
Investigational New Drug Application #075537 and Investigational New Drug
Application #076680” (collectively, the “US INDs”) and any and all other
Investigational New Drug Applications or their foreign equivalents (including
any clinical trial authorizations) for the Compound held by Seller or any of its
Affiliates as of the Effective Date.
“Excluded Services” means corporate management, legal, insurance, treasury, tax,
travel planning services, meeting planning services, public affairs, internal
audit and all other services not specifically covered by a Work Order or any
Change Order.
“FTE” means, with respect to the Initial Services, the equivalent of the work of
one employee of Seller full time for one Calendar Year (consisting of at least a
total of [***] hours per Calendar Year of work in directly providing the Initial
Services). If a Change Order contemplates that any Seller employee would devote
fewer than [***] hours per year in providing the Initial Services, such employee
shall be treated as an FTE on a pro-rata basis, calculated by dividing the
actual number of hours worked by such employee in providing the Initial Services
by [***]. Any employee who devotes more than [***] hours per year in providing
the Initial Services shall be treated as one (1) FTE, unless otherwise indicated
in a Change Order. With respect to the Additional Services, “FTE” means the
equivalent of the work of one employee of Seller full time for one Calendar Year
(consisting of at least a total of [***] hours per Calendar Year of work in
directly providing the Additional Services). Any employee who devotes more than
[***] hours per year in providing the Additional Services shall be treated as
one (1) FTE, unless otherwise indicated in a Change Order.
“FTE Costs” means, with respect to any Calendar Quarter, the product of (i) the
estimated total number of FTEs during such Calendar Quarter, multiplied by (ii)
the FTE Rate applicable to such Calendar Quarter.
“FTE Rate” means (i) with respect to the Initial Services, [***] per Calendar
Year, or [***] per Calendar Quarter and (ii) with respect to the Additional
Services, [***] per Calendar Year, or [***] per Calendar Quarter. For clarity,
with respect to Additional Services, the FTE Rate converted to an hourly format
equals [***] per hour (i.e., the [***] fee per Calendar Year divided by [***]
hours), regardless of the number of hours devoted by Seller.
“Ongoing Trials Information” means all materials, contracts, agreements,
documents, data (including data contained in case report forms and all
pharmacovigilance data and safety database information), information, records
and reports that are either (i) generated or created (including by any clinical
trial site or investigator or by any Pass-Through Contractor) in the conduct of
the Ongoing Trials or (ii) disclosed or learned by Seller in the conduct of the
Ongoing Trials and, in any case, relate solely to the Compound or the Ongoing
Trials.
“Pass-Through Contractors” means the counterparties that have entered into the
Pass-Through Agreements with Seller.
“Person” means any individual, firm, corporation, partnership, limited liability
company, trust, joint venture, Governmental Entity or other entity.
“Privacy Laws” means all Laws with respect to the collection, use, transfer,
storage, deletion, processing (both by computer and manually), combination or
other use of subject or other personal data, including the Health Insurance
Portability and Accountability Act of 1996, as amended by the Health Information
Technology for Economic and Clinical Health Act of 2009, including the
regulations promulgated thereunder, Directive 95/46/EC of the European
Parliament and of the Council of 24 October 1995 (while still in effect), the
General Data Protection Regulation (GDPR) (EU 2016/679), and any other
comparable foreign Laws relating to the security or privacy of medical
information, and any applicable state privacy Laws.
“Regulatory Documentation” means all (i) regulatory applications, submissions,
registrations, licenses, authorizations, filings (including Drug Approval
Applications) and approvals, and (ii) correspondence, notifications and reports
submitted to or received from Governmental Entities (including regulatory
authority meeting requests, minutes and official contact reports relating to any
communications with any regulatory authority) and all supporting documents with
respect thereto, in each case, ((i) and (ii)), relating to the Compound or
Product.
“Service Period” means (i) with respect to any particular Initial Service, the
period between the Effective Date and the end date of such Initial Service
performed (“Initial Service Period”), and (ii) with respect to any particular
Additional Service, the period between the Restated Effective Date and the end
date of such Additional Service performed (“Additional Service Period”), in each
case, ((i) and (ii)), as set forth in the applicable Work Order or, if
applicable, any Change Order.

1.2    Additional Defined Terms    . For purposes of this Agreement, the
following capitalized terms have the meanings set forth in the pages indicated:
ARTICLE 2    
Accountant, 2
Additional Service, 2
Additional Service Period, 3
Additional Services, 2
Additional Services Fees, 13
Additional Services Key Employee, 5
Additional Work Order, 2
Affiliate, 2
Aggregate Expense Amount, 14
Agreement, 1
Applicable Company Employees, 6
Applicable Employees, 5
Applicable Laws, 2
Assigned Contract, 8
Breaching Party, 23
Budget, 2
Change Order, 3
Chosen Courts, 27
Clinical Trial Materials, 2
Clinical Trial Service Period, 7
Clinical Trial Services, 7
CMC, 18
Company, 1
Company Indemnitees, 21
Company Property, 17
Complaining Party, 23
Compound INDs, 2
Confidential Information, 18
Debarred/Excluded, 13
Development Safety Update Report, 9
Disclosing Party, 19
Dispute, 28
Documentation, 12
DSUR, 9
Effective Date, 1
Excluded Services, 2
Extent, 2
Force Majeure Event, 25
FTE, 2
FTE Costs, 2
FTE Rate, 2
ICSR, 10
include, 2
Including, 2
Individual Case Safety Report, 10
Initial Service, 2
Initial Service Fee, 2
Initial Service Period, 3
Initial Services, 2
Initial Services Fees, 2
Initial Services Key Employee, 5
Initial Work Order, 2
Invoice Dispute, 15
MAA, 23
NDA, 10
Notice, 25
Notice Period, 23
Ongoing Trials Information, 3
Original Agreement, 1
Other Seller Costs, 14
Out-of-Pocket Costs, 13
Parties, 1
Party, 1
Pass-Through Agreements, 1
Pass-Through Contractors, 3
Payments, 15
Permitted Use, 20
Person, 3
Privacy Laws, 3
Product DSUR, 9
Purchaser, 1
Receiving Party, 19
Regulatory Documentation, 3
Restated Effective Date, 1
Retention Period, 12
Safety Information, 9
Seller, 1
Seller Indemnitees, 21
Seller Intellectual Property, 17
Service, 2
Service Period, 3
Services, 2, 13
Stock Purchase Agreement, 1
Term, 22
Third Party Claims, 21
Third Party Materials, 18
Transfer Date, 7
Transition Managers, 11
US INDs, 2
Work Order, 2

2.1    Interpretation    . All Schedules and Exhibits annexed hereto are hereby
incorporated in and made a part of this Agreement as if set forth in full
herein. Any capitalized term used in the Schedules or the Exhibits, but not
otherwise defined therein, shall have the meaning as defined in this Agreement
or the Stock Purchase Agreement, as applicable. References to defined terms in
the singular shall include the plural and references to defined terms in the
plural shall include the singular. “Extent” in the phrase “to the extent” means
the degree to which a subject or other thing extends, and such phrase does not
mean simply “if”. “Including” (and, with correlative meaning, “include”) means
including, without limiting the generality of any description preceding or
succeeding such term, and the rule of ejusdem generis will not be applicable to
limit a general statement preceded, followed by or referable to an enumeration
of specific matters, to matters similar to those specifically mentioned. The
descriptive headings of the several Articles and Sections of this Agreement and
the Table of Contents to this Agreement are inserted for convenience only, do
not constitute a part of this Agreement and shall not affect in any way the
meaning or interpretation of this Agreement. All references herein to
“Articles,” “Sections”, “Schedules” or “Exhibits” shall be deemed to be
references to Articles or Sections of this Agreement or Schedules or Exhibits
hereto unless otherwise indicated. The terms “hereof,” “herein,” “hereby” and
derivative or similar words refer to this entire Agreement. All accounting terms
used herein and not expressly defined herein shall have the meanings given to
them under GAAP. Unless otherwise specified or where the context otherwise
requires, (A) wherever used, the word “or” is used in the inclusive sense
(and/or), (B) references to a Person are also to its successors and permitted
assigns, (B) references to a Law include any amendment or modification to such
Law and any rules or regulations issued thereunder, in each case, as in effect
at the relevant time of reference thereto, (C) references to monetary amounts
are denominated in Dollars, and (D) references to any agreement, instrument or
other document in this Agreement refer to such agreement, instrument or other
document as originally executed or, if subsequently amended, replaced or
supplemented from time to time, as so amended, replaced or supplemented and in
effect at the relevant time of reference thereto. To the extent that any terms
set forth in the Original Agreement conflict with the terms of this Agreement,
from and after the Restated Effective Date the terms of this Agreement shall
control.

ARTICLE 3    
SERVICES

3.1    Provision of Services    . The Parties have agreed upon (a) the initial
work order attached hereto and incorporated herein as Schedule 2.1 (the “Initial
Work Order”), which, as of the Effective Date, includes an estimated number of
FTEs required to provide the Initial Services, the agreed-upon FTE Costs payable
for each Initial Service (each, an “Initial Services Fee” and collectively, the
“Initial Services Fees”), and the budget for payment of each Initial Service Fee
on a Calendar Quarter basis and the anticipated Out-of-Pocket Costs (the
“Budget”) and, which describes certain deliverables to be provided and certain
tasks and activities to be performed by Seller pursuant to this Agreement (each,
an “Initial Service” and collectively, the “Initial Services”) and the Service
Period for each Initial Service; and (b) the additional work order attached
hereto and incorporated herein as Schedule 2.2 (the “Additional Work Order”, and
together with the Initial Work Order, each a “Work Order”), which, as of the
Restated Effective Date, includes certain additional tasks and activities to be
performed by Seller pursuant to this Agreement (each, an “Additional Service”
and collectively, the “Additional Services”) and the Service Period for each
Additional Service. For purposes of this Agreement, a “Service” means an Initial
Service or an Additional Service, and the “Services” means, collectively, the
Initial Services and the Additional Services. Any changes to the Services or a
Work Order, including any modification to the applicable Services Fees, the
Budget or any Service Period, shall be made only with the written approval of
both Parties and shall be detailed in a written amendment to such Work Order,
which shall be deemed incorporated herein upon execution by both Parties’
Transition Managers (“Change Order”); provided, that Seller shall not
unreasonably withhold consent to any Change Order for tasks that are required in
order to perform the Additional Services, but has the discretion to take into
account the time required to complete such additional tasks and resourcing for
purposes of prioritization, and any Services so provided under any Change Order
shall be on fee terms set forth in such Change Order, which shall be
substantially consistent with the fee terms set forth in this Agreement. All
Change Orders, including any increases in the applicable Services Fees and any
changes in the Budget (including increases or decreases due to acceleration of
activities) must be approved and signed by the Parties prior to Seller
commencing or accelerating any work arising from such change or charging any
costs that exceed the applicable Services Fees or Budget; provided, however,
that (i) the Company shall not unreasonably withhold, condition or delay
approval of any Change Order that results from circumstances not within the
reasonable control of Seller or its Affiliates (including any delay or extension
of the Ongoing Trials or any requirement by a Governmental Entity or Applicable
Law) and (ii) if the Company so unreasonably withholds, conditions or delays, or
otherwise refuses to grant, consent to such Change Order, Seller shall have no
obligation to provide, or cause to be provided, any work or Service that is the
subject of such Change Order. Only the Transition Managers shall be authorized
to execute any Change Order. To the extent that any terms set forth in a Work
Order or any Change Order conflict with the terms of this Agreement, the terms
of this Agreement shall control unless such Work Order or Change Order
specifically references a provision of this Agreement and indicates that the
terms of such Work Order or Change Order shall control over such provision. Any
deliverables to be provided hereunder shall be provided in accordance with the
acceptance criteria included in the applicable Work Order or any Change Order
or, if there are no acceptance criteria for a deliverable included in the
applicable Work Order or any Change Order, such deliverable shall be subject to
the Company’s reasonable approval.

3.2    Services Performed by Affiliates and Third Parties    . With respect to
the Initial Services or any Additional Service the performance of which has
commenced prior to the date hereof, Seller shall have the right to perform the
Services either itself or through any Affiliate or through any Third Party that
performs Services for the benefit of Seller or its Affiliates as of the
Effective Date (in the case of any Initial Service) or as of the date on which
Seller commenced performing such Additional Service (in the case of any such
Additional Service). With respect to the Additional Services, except to the
extent provided in the immediately preceding sentence, Seller shall have the
right to perform the Services either itself or through any Affiliate. Except as
provided in the preceding sentences of Section 2.2 or as set forth in Section
2.3, Seller may not subcontract or delegate any of the Services to a Third Party
without the Company’s prior written consent. In the event the Company withholds
any consent requested by Seller to subcontract or delegate the performance of
Additional Services to a Third Party due to prioritization of Seller’s internal
resources or projects, the Parties agree to amend the Additional Work Order in
good faith to modify the Additional Services that were to be performed by such
Third Party to enable Seller to achieve such prioritization. In the event that
the Company does so consent, then any agreement entered into by Seller with the
permitted Third Party subcontractor shall, to the extent reasonably practicable,
name the Company as intended third party beneficiary of such agreement and
provide for ownership and allocation of Intellectual Property rights and for
obligations of confidentiality, record-keeping, and access that are consistent
with the terms of this Agreement. Notwithstanding any permitted subcontracting,
subject to Section 6.3, Seller shall remain liable for the performance of any
obligations hereunder that it delegates to a subcontractor, and Seller hereby
expressly waives any requirement that the Company exhaust any right, power or
remedy, or proceed directly against such subcontractor, for any obligation or
performance hereunder, prior to proceeding directly against Seller.

3.3    Pass-Through Agreements     . Subject to this Section 2.3, the Company
hereby consents to Seller’s subcontracting and delegation to the Pass-Through
Contractors of the Ongoing Trials-related services set forth in the Pass-Through
Agreements. Within seven (7) Business Days after the Effective Date, Seller
shall instruct each of the Pass-Through Contractors to copy the Company’s
Transition Manager on all email communications with respect to all matters
pertaining to the Ongoing Trials (but not with respect to Seller’s unrelated
business or products) and to provide to the Company, at the same time as the
Pass-Through Contractor provides to Seller, all updates, reports, documentation
and other information relating to the Ongoing Trials to be provided under the
Pass-Through Agreements; provided, however, that in the event the Pass-Through
Contractor fails to follow such instructions with respect to any such
communications, Seller shall promptly inform the Company of all such
communications from such Pass-Through Contractor related to the status, cost and
progress of, and other substantive matters with respect to the Ongoing Trials.
For clarity, Seller shall not have any liability for any Pass-Through
Contractor’s failure to follow such instructions. From and after the Effective
Date, subject to Section 2.4.3, Seller shall continue to interact directly with
the Pass-Through Contractors and shall have the authority to make ordinary
course decisions with respect to all matters pertaining to the Ongoing Trials;
provided, that, in the course of interacting with the Pass-Through Contractors
or making decisions pertaining to the Ongoing Trials, Seller shall not take any
action that (a) would cause Seller to breach any Pass-Through Agreement or to
violate any Applicable Laws or (b) is inconsistent with the Company’s reasonable
directions to Seller or final decision-making authority as provided in Section
2.4.3. Subject to the foregoing, Seller shall continue to perform its
obligations and comply with all of the terms applicable to Seller under the
Pass-Through Agreements (except to the extent any act or omission by the Company
materially inhibits or prevents Seller’s performance of such obligations) and,
at the request of the Company, Seller shall enforce the provisions and
obligations of the Pass-Through Contractors under each of the Pass-Through
Agreements for the benefit of the Company. Seller covenants and agrees that it
shall not amend, waive any right under, voluntarily terminate, or, except as set
forth in this Section 2.3, take any other material action under or with respect
to any of the Pass-Through Agreements as they relate to the Ongoing Trials
without the Company’s prior written consent. If the Company consents to the
subcontracting or delegation to a Third Party of any Services in accordance with
Section 2.2, any agreement between Seller and such Third Party governing the
performance by such Third Party of such Service shall be deemed a Pass-Through
Agreement and such agreement and the performance of such Service shall be
subject to this Section 2.3.

3.4    Services Standard; Applicable Employees    .
3.4.1    The Company acknowledges that Seller is not in the business of
providing services to Third Parties and is entering into this Agreement only in
connection with the transactions contemplated by the Stock Purchase Agreement.
Seller shall perform the Services in accordance with the terms and conditions of
this Agreement, including the applicable Work Order, with substantially the same
degree of skill, quality and care utilized by Seller (or its Affiliates) in
performing such activities for the Company prior to the Effective Date (subject
to any requirements of Section 2.3 and this Section 2.4) and in compliance with
all Applicable Laws.
3.4.2    Seller shall ensure that its (and its Affiliates’) employees who
perform Services (the “Applicable Employees”) are properly trained and
sufficiently qualified and experienced to perform the Services in accordance
with this Section 2.4. Without limiting the foregoing, unless the Company agrees
otherwise in writing (such agreement not to be unreasonably withheld,
conditioned or delayed), Seller shall utilize in the performance of the Initial
Services the same employees utilized by Seller in performing such activities for
the Company prior to the Effective Date, or employees of Seller who have
substantially equivalent training, qualifications and experience as such
employees, provided, that in each case such employees (including those utilized
to perform activities for the Company prior to the Effective Date) meet the
standards set forth in this Section 2.4. Notwithstanding the foregoing, subject
to resignations or terminations in accordance with Seller’s policies, Seller
shall utilize each of the Applicable Employees listed in Schedule 2.4.2 (Part A)
(each an “Initial Services Key Employee”) to perform the same Initial Services
as such Initial Services Key Employee provided for the Company prior to the
Effective Date, and Seller shall not diminish or alter (through transfer,
reassignment or otherwise) the scope of any Initial Services or any obligations
with respect to the Initial Services performed by any Initial Services Key
Employee prior to completion of the applicable Initial Services and expiration
of the Service Period applicable to the Initial Services assigned to such
Initial Services Key Employee, without the prior written consent of the Company.
Seller shall notify the Company (through the Transition Managers) if any Initial
Services Key Employee provides notice of resignation to or is terminated by
Seller in accordance with Seller’s policies. With respect to the performance of
Additional Services during the Additional Service Period, Seller shall utilize
each of the Applicable Employees listed in Schedule 2.4.2 (Part B) (each an
“Additional Services Key Employee”) to perform the Additional Services;
provided, that should any Additional Services Key Employee becomes unavailable
to perform any Additional Service(s) due to resignation, termination, death,
disability, illness or Seller’s prioritization of internal resources or
projects, Seller shall have the right to assign such Additional Service(s) to
another employee with the requisite training, qualifications, availability and
experience as is required to perform such Additional Service(s) as set forth in
the Additional Work Order. In the event any Additional Service(s) performed by
any Additional Services Key Employee are reassigned to another employee due to
Seller’s prioritization of internal resources or projects, Seller agrees that
such Additional Services Key Employee will coordinate with such other employee
to ensure there is appropriate knowledge transfer and oversight to perform such
Additional Service(s). Except as otherwise permitted under this Agreement,
Seller shall not diminish or otherwise alter the scope of any Additional Service
prior to the completion of such Additional Service or the expiration or
termination of the Service Period applicable to such Additional Service, without
the prior written consent of the Company.
3.4.3    Notwithstanding anything to the contrary herein, the Company shall have
the authority to reasonably direct the Applicable Employees in the manner of
performing the Services and shall have final decision-making authority with
respect to matters that, in the Company’s sole judgment, would be expected to
materially affect the Ongoing Trials, the time to completion thereof or
materially affect the cost of completing the Ongoing Trials, or the Services
themselves. All of the Company’s directions to Applicable Employees shall be
made through Seller’s Transition Manager, or (a) with respect to Initial
Services, the Initial Services Key Employees or (b) with respect to Additional
Services, the Additional Services Key Employees. Seller’s Transition Manager and
the Initial Services Key Employees or Additional Services Key Employees (as the
case may be) shall have the responsibility within Seller’s organization for
interacting directly with the other Applicable Employees and shall have the
authority to cause such other Applicable Employees to carry out the Company’s
reasonable directions. Seller shall instruct the Applicable Employees to, and
shall take reasonable actions to ensure that the Applicable Employees shall, (a)
comply with all reasonable directions relating to the Services given by the
Company (and communicated through Seller’s Transition Manager and the Initial
Services Key Employees or Additional Services Key Employees (as the case may be)
and (b) respond promptly to the Company’s reasonable inquiries relating to the
Services. The Company shall instruct its employees with responsibility for
carrying out the Company’s rights and duties under this Agreement or otherwise
with respect to the Ongoing Trials (the “Applicable Company Employees”) to, and
shall take reasonable actions to ensure that such employees shall respond
promptly to Seller’s reasonable inquiries relating to the Services. In the event
that either Party (the “Notifying Party”) reasonably believes that the
Applicable Employees or the Applicable Company Employees, as applicable, are
failing to promptly respond to such inquiries or that the Applicable Employees
are failing to comply with all reasonable directions relating to the performance
of the Services given by the Company in accordance with this Section 2.4.3, the
Notifying Party’s Transition Manager shall notify the other Party’s Transition
Manager of such unresponsiveness and the Transition Managers shall discuss and
work together in good faith to resolve any impact such failure may have to the
provision of the Services. In the event such failures to promptly respond or to
comply with reasonable directions are not resolved within ten (10) Business Days
after the Notifying Party’s Transition Manager provides notice of such
failure(s) to the other Party’s Transition Manager, or if any such failure that
is successfully resolved by the Transition Managers recurs two (2) or more times
in the three (3) month period following such resolution, such failure(s) shall
be deemed to be a material breach of this Agreement.
3.4.4    Each Party acknowledges and agrees that the Applicable Employees are
not, and are not intended to be or be treated as, employees of the Company or
any of its Affiliates, and that such individuals are not, and are not intended
to be, eligible to participate in any benefits programs or in any “employee
benefit plan,” as such term is defined in Section 3(3) of ERISA, that may be
sponsored by the Company or any of its Affiliates or that may be offered from
time to time by the Company or its Affiliates to its or their own employees.
Except as expressly set forth in this Agreement, from and after the Effective
Date, Seller’s and the Company’s respective obligations and rights with respect
to the Company Business shall be as set forth in the Stock Purchase Agreement
and any applicable other Ancillary Agreements. For the avoidance of doubt, the
Services do not include, and Seller shall have no obligation to provide, any of
the Excluded Services; provided that, for clarity, Seller shall provide
oversight and management incidental to the Services.
3.4.5    With respect to the Initial Services, Seller shall perform its
obligations and comply with all of the terms applicable to Seller under all of
its agreements with Third Parties that perform Services for the benefit of
Seller or its Affiliates as of the Effective Date and with any other permitted
Third Party subcontractors (except to the extent any act or omission by the
Company prevents Seller’s performance of such obligations).

3.5    Ongoing Trials; Drug Approval Applications    .
3.5.1    As set forth in the Initial Work Order, Seller oversaw and managed the
Ongoing Trials, including the services and activities of the Pass-Through
Contractors under the Pass-Through Agreements, subject to Section 2.3 and the
control and direction of the Company as set forth in this Agreement. Seller held
and maintained the Compound INDs as the sponsor of the Ongoing Trials during the
Service Period for the Services set forth in the Initial Work Order relating to
the Ongoing Trials (such Services, the “Clinical Trial Services” and such
period, as the same may be modified in a Change Order or terminated by the
Company pursuant to Section 7.2.1, the “Clinical Trial Service Period”). As
sponsor of the Ongoing Trials, Seller represents and warrants it complied with
all Applicable Laws, including regulations applicable to sponsors under 21 CFR
312. As of the Restated Effective Date, Seller and the Company filed all
documents required to be filed with each applicable Governmental Entity and took
all other actions as reasonably may have been required to effectuate the
transfer of the Compound INDs from Seller to the Company in the Territory in
accordance with Applicable Laws (the date on which the Compound INDs were
transferred from Seller to the Company in the Territory in accordance with
Applicable Laws, the “Transfer Date”). After the Transfer Date, all Drug
Approval Applications (other than the Compound INDs) shall be filed under the
Company’s name and the Company may designate Seller as its agent if the Company
deems it necessary or useful for Seller, in the course of performing the
Services, to respond to inquiries from Governmental Entities with respect to
such filings. Seller shall not have any obligations with respect to
post-approval obligations imposed by relevant Governmental Entities in
connection with the grant of any Drug Approval Application.
3.5.2    The Company commits to (a) complying with the reporting requirements
for important safety information: reporting any unexpected fatal or
life-threatening adverse events associated with the use of the Compound or any
Product by telephone or fax no later than seven (7) days after initial receipt
of the information; and reporting any adverse experiences associated with the
use of the Compound or any Product that is both serious and unexpected no later
than fifteen (15) days after initial receipt of the information; and submitting
annual reports within sixty (60) days of each anniversary of the date on which
each US IND went into effect, (b) continue the agreements, promises, and
conditions made by Seller to FDA and contained in the application with respect
to each US IND, and (c) notify FDA of any changes made to any US IND in
accordance with the new principles and requirements identified under 21 CFR 312
as clinical trials continue.
3.5.3    Subject to Section 2.7.1, Seller shall be responsible for preparing and
submitting reports originating from the Ongoing Trials, including the End of
Study Report with respect to the Ongoing Trials, to applicable regulatory
authorities, ethics committees, institutional review boards and investigative
sites as required by Applicable Law. Subject to Section 2.7.1, Seller shall
provide to the Company the final version of the End of Study Report with respect
to the Ongoing Trials upon submission to the applicable regulatory authority or,
if not submitted, within twelve (12) months after the end of data collection.
3.5.4    Seller shall be required to perform the obligations set forth in
Section 2.5.1 only during the Initial Service Period and shall not be required
to perform such obligations during the Additional Service Period.
3.5.5    During the Additional Service Period, Seller shall be responsible for
performing only those Additional Services expressly set forth in the Additional
Work Order and shall be compensated for such work in accordance with Section
3.1. Any additional tasks and activities not contained within the Additional
Work Order that the Company requests that Seller perform must be agreed upon by
both Parties and, if so agreed upon, must be documented in accordance with
Section 2.1. For clarity, Seller is not under any obligation to agree to provide
any additional tasks or activities requested by the Company.

3.6    Assigned Contracts    . Prior to or promptly following the Clinical Trial
Service Period (with respect to Contracts pertaining to the Clinical Trial
Services) and at any time during the Term (with respect to other Contracts), the
Parties will agree on which Contracts, if any, need to be assigned by Seller to
the Company (collectively, the “Assigned Contracts”). As promptly as practicable
thereafter, subject to the receipt of all necessary Consents of Third Parties,
Seller shall assign, transfer, convey and deliver to the Company each of the
Assigned Contracts. In the event the Consent of a Third Party is required in
order to so assign, transfer, convey or deliver an Assigned Contract, Seller
shall use commercially reasonable efforts to obtain such Consent for a period of
six (6) months following the date on which the Parties agree to assign the
applicable Assigned Contract, provided, that Seller shall have no obligation to
(a) make any payments to any Third Party or incur any obligations in respect of
any such Consent which payments are not subject to reimbursement by the Company
or which obligations are not assumed by the Company hereunder, or (b) enter into
any alternative arrangements that are not commercially reasonable or that are
not subject to reimbursement by the Company hereunder, in either case, in the
event that any such Consent is not obtained. In the event Seller is unable to
obtain the necessary Consent to assign any Assigned Contract, Seller shall
continue to enforce such Assigned Contract for the benefit of the Company for
the six (6) month period following the date on which the Parties agree to assign
the applicable Assigned Contract or if longer, for so long as any ongoing
obligations of the Third Party under such Assigned Contract (such as
confidentiality obligations) remain in effect (provided that the Company pays or
otherwise performs any corresponding obligation under any such Assigned
Contract). The Company shall reasonably cooperate with Seller in its efforts to
obtain any Third Party Consents contemplated by this Section 2.6.

3.7    Regulatory Services    .
3.7.1    In the event Seller, in the course of performing the Services, is
required to submit any Regulatory Documentation to a Governmental Entity, Seller
shall provide the Company a draft of such Regulatory Documentation as far in
advance of the intended date of submission as reasonably possible and shall
incorporate any comments thereto provided by the Company. Seller shall promptly
notify the Company of any other Regulatory Documentation received from or to be
submitted to any Governmental Entity, including correspondence, meeting minutes
and summaries received by Seller from, or to be submitted by Seller to, any
Governmental Entities, and shall provide the Company with copies thereof within
five (5) Business Days after receipt thereof or, if such documents are prepared
by Seller for submission to Governmental Entities, sufficiently in advance of
such submission so as to allow the Company to review and finalize the content of
such submission with Seller. Notwithstanding the foregoing, Seller shall not be
required to delay a regulatory submission to any Governmental Entity or
incorporate any comments of the Company to the extent doing so would cause
Seller to violate the requirements of a Governmental Entity or Applicable Laws.
For clarity, the terms of this Section 2.7.1 shall apply to correspondence with,
inquiries or requests from, or reporting to Governmental Entities regarding
adverse drug reactions/experiences, safety data and other information concerning
the safety of Product or the Compound (“Safety Information”).
3.7.2    Seller shall provide the Company with reasonable advance notice of all
meetings, conferences and discussions scheduled with any Governmental Entity
concerning the Compound or Product, and shall incorporate any input from the
Company in preparing for such meetings, conferences or discussions; provided,
that Seller shall not be required to incorporate any input from the Company to
the extent doing so would cause Seller to violate the requirements of a
Governmental Entity or Applicable Laws. One or more representatives of the
Company shall have the right to attend and participate in all such meetings,
conferences, and discussions to the extent not prohibited by Applicable Law or
the applicable Governmental Entity, and Seller shall facilitate such
participation. If the Company elects not to participate in such meetings,
conferences or discussions, Seller shall provide the Company with written
summaries of such meetings, conferences or discussions as soon as reasonably
practicable after the conclusion thereof.
3.7.3    During the Initial Service Period, Seller shall be responsible for
submitting the DSUR involving the Product (the “Product DSUR”) or the Executive
Summary of the Product DSUR to applicable regulatory authorities, ethics
committees, institutional review boards and investigative sites. Before
submitting the final version of the Product DSUR, Seller shall send a draft to
the Company for review and comment as far in advance of the intended date of
submission as reasonably possible and Seller shall incorporate any comments
thereto provided by the Company. Notwithstanding the foregoing, Seller shall not
be required to incorporate any of the Company’s comments to the extent doing so
would cause Seller to violate the requirements of a Governmental Entity or
Applicable Laws. Seller shall provide the final version of the Product DSUR to
the Company at the same time that Seller submits the Product DSUR to any
regulatory authorities. For purposes hereof, “Development Safety Update Report”
or “DSUR” shall mean a periodic summary of safety information for regulatory
authorities, including benefit-risk considerations, for a drug, biologic or
vaccine under development or study, prepared by the sponsor of the clinical
study(ies).
3.7.4    During the Initial Service Period, Seller shall be responsible for
submitting the Investigational New Drug (IND) Safety Reports for the Product to
applicable regulatory authorities. Before submitting the final version of such
IND Safety Report, to the extent practicable, Seller shall send a draft to the
Company for review and comment as far in advance of the intended date of
submission as reasonably possible and Seller shall incorporate any comments
thereto provided by the Company. Notwithstanding the foregoing, Seller shall not
be required to incorporate any Company comments to the extent doing so would
cause Seller to violate the requirements of a Governmental Entity or Applicable
Laws. Seller shall provide the final version of the IND Safety Report for the
Product to the Company at the same time that Seller submits the IND Safety
Report for the Product to any regulatory authorities.
3.7.5    On a monthly basis during the Initial Service Period, Seller shall
provide to the Company listings which provide ICSR submission data to the EMA
occurring during the previous month. The listings shall include the number of
ICSRs submitted, the submission due dates and the dates submitted. In addition,
Seller shall forward to the Company the expedited ICSRs within five (5) Business
Days after submission to the EMA. In the event any ICSRs were submitted late to
the EMA or the FDA: (a) Seller shall provide the Company a written explanation
of the delay and corrective action taken or proposed to be taken; (b) the
Parties shall discuss the matter and align on corrective action; and (c) Seller
shall implement such corrective action and any other necessary safeguards to
ensure that no further late reports are submitted. For purposes of this
Agreement, “Individual Case Safety Report” or “ICSR” means a document that
presents the most complete, relevant information provided by a reporter to
describe an individual subject’s adverse event(s)/adverse reaction(s) related to
the administration of one or more (investigational) medicinal products at a
particular point in time.
3.7.6    Seller shall be required to perform the obligations set forth in
Section 2.7.1 through Section 2.7.5 only during the Initial Service Period and
shall not be required to perform such obligations during the Additional Service
Period.
3.7.7    Consistent with Section 2.5.5, during the Additional Service Period,
Seller shall perform only those regulatory Services set forth in the Additional
Work Order for the New Drug Application (within the meaning of the FDCA)
submitted or to be submitted by the Company for a Product relating to the
E5501-G000-310 and E5501-G000-311 studies (the “NDA”).

3.8    Pharmacovigilance    . Until the later of: (i) the expiration of the
Initial Service Period, and (ii) the Transfer Date, Seller shall bear
responsibility for pharmacovigilance relating to the Compound and Products,
including for the timely reporting of all adverse drug reactions/experiences and
aggregate safety data relating to the Compound. As part of the Initial Services,
Seller shall communicate with the Company regarding Product pharmacovigilance
matters. Without limiting the foregoing, Seller shall instruct Quintiles, Inc.
(or any successor entity with respect to any acquisition or merger of Quintiles,
Inc.) to copy the Company’s Transition Manager on all communications
transmitting Safety Information to Seller, and in the event Seller receives any
Safety Information that meets the criteria for a Serious, Suspected Adverse Drug
Reaction (as defined in ICH E2A) in a communication to which the Company is not
copied, Seller shall send the source documents including such Safety Information
that were transmitted by Quintiles, Inc. (or any successor entity with respect
to any acquisition or merger of Quintiles, Inc.) to the Company, or other
mutually agreed format, via email or fax as soon as possible, but, in any event,
not later than one (1) Business Day after Seller receives such Safety
Information, and, in the event Seller receives any information concerning any
investigation, inquiry or other action by any Governmental Entity concerning the
safety of the Compound or Product, Seller shall send such information to the
Company via email or fax as soon as possible, but in any event, no later than
two (2) days after Seller receives notice of such investigation, inquiry or
other action. Seller agrees to reasonably cooperate with the Company to make
available to the Company such Safety Information as may be reasonably requested
by the Company. As soon as reasonably practicable after the Initial Service
Period or such earlier time as may be requested in writing by the Company,
Seller shall take all actions as reasonably may be required to effectuate the
transfer to the Company of all Safety Information, including the portion of
Seller’s global safety database that pertains to the Compound and the Products.
In the event of any inconsistency between Section 2.7 and Section 2.8 regarding
the time periods for transmittal to the Company of Regulatory Documentation that
constitutes Safety Information, the time periods in Section 2.8 will govern.

3.9    Location of Services Provided; Travel Expenses    . Seller shall provide
the Services to the Company, as applicable, from locations of Seller’s choice in
its sole discretion unless Services are required to be performed at a specific
location identified in the applicable Work Order. Should the provision of
Services require any personnel of Seller to travel (a) with respect to Initial
Services, beyond 50 miles from his or her employment location or (b) with
respect to Additional Services, beyond his or her employment location, in each
case ((a) and (b)), the Company shall reimburse Seller for all reasonable
travel-related costs, consistent with Seller’s travel policy, which costs shall
be deemed Other Seller Costs and shall be reimbursed in accordance with Section
3.2; provided, however, that the Company shall have no obligation to reimburse
Seller for such travel-related costs unless such travel is pre-approved by the
Company and any expenses in excess of $1,000 associated with such travel are
pre-approved by the Company.

3.10    Transition Management    . Each Party designated an appropriate point of
contact for all questions and issues relating to the Services (the “Transition
Managers”). Each of Seller and the Company may, by written notice given to the
other such Party, replace its Transition Manager. The Transition Managers shall
meet at least twice per month, or on such other schedule as mutually agreed upon
by Seller and the Company, during the Term in person or telephonically in order
to discuss the status of the Services and to manage any open issues relating to
the Services. In addition, if and as reasonably requested by the Company, the
Transition Managers will establish transition teams composed of representatives
from each Party who have the requisite experience and authority to enable such
representatives to monitor, coordinate and make decisions on behalf of the
Parties with respect to the Services (or any particular Service).

3.11    Cooperation    . Each of the Company and Seller shall use commercially
reasonable efforts to cooperate with one another in all matters relating to the
provision and receipt of the Services. Without limiting the generality of the
foregoing sentence, the Company shall permit Seller, its Affiliates and its and
their employees and agents reasonable access, upon reasonable notice during
regular business hours, to such personnel of the Company as are involved in
receiving or overseeing the Services, and data and records of the Company as
reasonably requested by Seller to facilitate Seller’s performance under this
Agreement. Seller shall be excused from performing any obligation under this
Agreement to the extent the Company’s failure to perform its obligations under
this Agreement prevents Seller’s performance of such obligation, including to
the extent any Service is dependent on the Company timely providing to Seller or
any of its Affiliates information, materials, products and like items in a
manner substantially similar in nature, quality and timeliness to the
information, materials, products and like items provided by the Company to
Seller and its Affiliates at the time of the Closing and the Company fails to so
provide such information, materials, products and like items; provided, however,
in the event that the Company fails to provide such information, materials,
products and like items, the Transition Manager of Seller shall provide notice
of such failure to the Transition Manager of the Company and the Transition
Managers shall discuss and work together in good faith to resolve any impact
such failure may have to the provision of the Services. Upon the Company’s
request, Seller shall reasonably cooperate with the Company to renegotiate the
terms of any existing agreement with a Third Party contractor that is required
for Seller to provide any Services in order to reduce (to the extent reasonably
possible) the amounts paid by Seller to such Third Party contractor in
connection with the Services. The Company shall reimburse Seller for all actual,
reasonably incurred, documented, out-of-pocket costs and expenses incurred by
Seller or its Affiliates in connection with such cooperation, which costs and
expenses shall be deemed Other Seller Costs and shall be reimbursed in
accordance with Section 3.2.

3.12    Documentation    . As part of the Services, Seller shall create and keep
(and shall cause its Affiliates and permitted subcontractors to create and keep)
accurate records, notes, reports, writings and other documentation reflecting
all work done and results achieved in performance of the Services (collectively,
“Documentation”), in tangible or electronic form, in a timely, accurate,
complete and legible manner. Seller shall (and shall cause its Affiliates and
permitted subcontractors to) maintain the Documentation during the Term and for
the longest of (a) five (5) years after expiration or termination of this
Agreement, (b) two (2) years after FDA approval of the New Drug Application for
the Product, or (c) the retention period required by Applicable Laws, if any
(“Retention Period”). During the Retention Period, upon reasonable advanced
notice during regular business hours, Seller shall make the Documentation
available for inspection and copying by the Company, at the Company’s sole cost
and expense. After the Retention Period, Seller shall provide the Company at
least sixty (60) days’ written notice before destroying any Documentation and,
if requested by the Company, Seller shall transfer the Documentation to the
Company or its designee at the Company’s expense.

3.13    Exclusions    . Notwithstanding anything herein to the contrary, in no
event shall Seller or any of its Affiliates be (a) obligated to provide any
Services that would be unlawful for Seller to provide or that would require
Seller to violate Applicable Law; (b) obligated to hire any additional employees
to perform the Services or maintain the employment of any specific employee,
except as set forth in Section 2.4.2 and, if applicable, the applicable Work
Order; (c) subject to Section 2.4, obligated to hire replacements for employees
that resign, retire or are terminated; (d) obligated to enter into retention
agreements with employees or otherwise provide any incentive beyond payment of
regular salary and benefits; (e) subject to Section 2.4, prevented from
transferring after the Effective Date any employees (other than the Initial Key
Employees) who were supporting the Company Business as of the Effective Date to
support other businesses of Seller or its Affiliates or to assume other roles
with Seller or its Affiliates to the extent such employees are not required to
provide Services; or (f) subject to Section 2.4, prevented from determining, in
its sole discretion, the individual employees (other than the Initial Key
Employees) who will provide Services.
3.14    Seller’s Representations, Warranties and Covenants. Seller hereby
represents, warrants and covenants to the Company as follows:
(a)    except to the extent such performance is expressly excused by this
Agreement, it shall perform the Services in compliance with the applicable Work
Order, all Applicable Laws and the standards set forth in Section 2.4; and
(b)    neither it, nor any of its Affiliates, nor to Seller’s Knowledge, any of
their respective officers, employees, agents, representatives, subcontractors or
other persons used in the performance of its obligations under this Agreement
has been debarred or suspended under 21 U.S.C. §335(a) or (b), excluded from a
federal health care program, debarred from federal contracting, or convicted of
or pled nolo contendere to any felony, or to any federal or state legal
violation (including misdemeanors) relating to prescription drug products or
fraud (“Debarred/Excluded”). Seller shall promptly notify the Company if Seller
becomes aware that it, any of its Affiliates, or any officer, employee, agent,
representative, subcontractor or other Person who is performing any activities
under this Agreement is or becomes Debarred/Excluded or receives notice of
action or threat of action to be Debarred/Excluded. In the event that Seller,
any of Seller’s Affiliates or any officer or employee of Seller or any of its
Affiliates who is performing any activities under this Agreement is or becomes
Debarred/Excluded or receives notice of action or threat of action to be
Debarred/Excluded, the Company shall have the right to terminate this Agreement.
In the event that any other Person who is performing any activities under this
Agreement on behalf of Seller is or becomes Debarred/Excluded or receives notice
of action or threat of action to be Debarred/Excluded, upon notice from the
Company, Seller shall promptly terminate the agreement under which such
activities are provided.

3.15    Exclusion of Warranties    . EXCEPT AS PROVIDED IN THIS AGREEMENT OR THE
STOCK PURCHASE AGREEMENT, NEITHER SELLER NOR ANY OF ITS AFFILIATES MAKES ANY
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE
SERVICES.

ARTICLE 4    
COMPENSATION

4.1    Services Fees    . In consideration for the performance of the Initial
Services by Seller, the Company shall pay the Initial Services Fees with respect
to the applicable Initial Services in accordance with the Budget. The Company
shall not be obligated to pay to Seller (a) for any Initial Service, any amount
in excess of the Initial Service Fee amount set forth in the Budget for
performance of such Initial Service or (b) Initial Services Fees that exceed, in
the aggregate, $8,540,000, unless, in each case ((a) and (b)), the Company
consents to do so in writing. In consideration for the performance of the
Additional Services by Seller, the Company shall pay Seller (i) a service fee on
a Calendar Quarter basis equal to (A) [***] for each of the second, third and
fourth Calendar Quarters of the 2018 Calendar Year and (B) [***] for the first
and second Calendar Quarter of the 2019 Calendar Year and (ii) the FTE Costs
payable for the Additional Services ((i) and (ii), collectively, the “Additional
Services Fees”). For purposes of this Agreement, the “Services Fees” means,
collectively, the Initial Services Fees and the Additional Services Fees.

4.2    Out-of-Pocket Costs    . In addition to the Services Fees, the Company
shall reimburse Seller for (a) all amounts paid by Seller to the Pass-Through
Contractors for performance of Ongoing Trials-related services under the
Pass-Through Agreements, (b) those out-of-pocket costs and expenses described in
the Budget, the Additional Work Order or any Change Order; (c) except as
provided in clauses (d) through (g) immediately below, any other actual,
reasonably incurred, documented, out-of-pocket costs and expenses paid by Seller
or its Affiliates to Third Party contractors in order to perform the Services;
((a) through (c), collectively, “Out-of-Pocket Costs”); (d) fees associated with
securing any Consents required from Third Party contractors pursuant to Section
2.6; (e) actual, reasonably incurred, documented, out-of-pocket costs or
expenses incurred by Seller, its Affiliates or subcontractors for the
extraction, conversion and transfer of data required to be provided to the
Company under this Agreement (to the extent not included in the Services); (f)
actual, reasonably incurred, documented, out-of-pocket costs or expenses
incurred by Seller or its Affiliates in connection with the delivery or
destruction of Clinical Trial Materials pursuant to Section 4.3; (g) Seller’s
and its Affiliates’ actual, reasonably incurred, documented, out-of-pocket costs
and expenses for the transfer and delivery to the Company of the tangible TSA
Assets and Company Property contemplated by Section 7.3; (h) Seller’s and its
Affiliates’ actual, reasonably incurred, documented, out-of-pocket costs and
expenses contemplated by Section 2.11; and (i) all reasonable travel-related
costs contemplated by and subject to Section 2.9 ((d) through (i), collectively,
“Other Seller Costs”); provided, that Seller provides the Company with
reasonably detailed documentation identifying such Out-of-Pocket Costs and Other
Seller Costs and, upon the Company’s request, provides the Company with receipts
and other reasonable supporting documentation. Except to the extent a lower
threshold is provided for in this Agreement, to the extent any Out-of-Pocket
Costs (other than as described in clause (a) immediately above) or Other Seller
Costs are not included in the Budget, the Additional Work Order or any Change
Order, Seller shall not incur any such costs in excess of [***] and the Company
shall have no obligation to reimburse any such costs in excess of [***], unless
approved in advance in writing by the Company. In addition, Seller shall allow
the Company to participate in discussions with Seller and any Third Party
regarding any agreement or other arrangement to pay Out-of-Pocket Costs (other
than as described in clause (a) immediately above) or Other Seller Costs (that,
in either case, are not included in the Budget, the Additional Work Order or any
Change Order) in excess of [***]. Out-of-Pocket Costs and Other Seller Costs
shall be reimbursed at actual cost without markup and, notwithstanding anything
herein to the contrary, shall not include any late fees or other penalties
incurred by Seller in connection therewith except to the extent caused by the
Company. The Company reserves the right to decline to pay unsupported or
unexplained costs or expenses and, except as provided in this Section, any costs
or expenses, not included in the Budget, the Additional Work Order or any Change
Order.

4.3     Invoicing    . Seller shall, on a Calendar Quarter basis, invoice the
Company for applicable Services Fees, Out-of-Pocket Costs and Other Seller
Costs. Seller will not invoice Company for FTE Costs for Additional Services
that are not performed. To the extent applicable, Services Fees (other than
those described in clause (i) of Section 3.1) will be prorated for any partial
Calendar Quarter based on the actual number of days in such Calendar Quarter for
which Seller was providing the applicable Services relative to the total number
of days in such Calendar Quarter. All Services Fees, Out-of-Pocket Costs and
Other Seller Costs shall be billed in arrears.

4.4    Excess Costs. If the aggregate amount of Initial Services Fees and
Out-of-Pocket Costs incurred in connection with the performance of the Initial
Services actually paid or reimbursed by the Company to Seller in cash hereunder
(including through payment of the principal amount of the Note) exceeds
$51,040,000 (the “Aggregate Expense Amount”), Purchaser shall be entitled to
deduct such excess amounts from the Milestone Payments payable by the Company
under Section 1.02(a) of the Stock Purchase Agreement in accordance with the
terms and conditions of such section.

4.5    Due Date    .
4.5.1    The Company shall pay the undisputed portion of each invoice for
Services Fees, Out-of-Pocket Costs and Other Seller Costs in cash promptly, but
in no event later than forty-five (45) days, after the date of receipt of such
invoice and acceptance of any deliverables to be provided. If there is any
dispute concerning any portion of an invoice for Services Fees, Out-of-Pocket
Costs or Other Seller Costs (an “Invoice Dispute”) that is not resolved by the
Parties within thirty (30) days after the date of such invoice, such Invoice
Dispute shall be referred for decision to the Accountant. The decision of the
Accountant shall be in writing and, except for manifest error on the face of the
decision, shall be binding on both Seller and the Company. The Company shall
bear and pay 100% of the cost of the Accountant unless the Accountant determines
all matters in such Invoice Dispute in favor of the Company, in which case
Seller shall bear and pay 100% of the cost of the Accountant. Any amount payable
by the Company or Seller based on the Accountant’s decision shall be paid within
fourteen (14) days after the date of such decision in accordance with this
Section 3.5.1. Each Party shall reasonably cooperate with the Accountant in
connection with the resolution of any Invoice Dispute.
4.5.2    Any payments under this Agreement that are not made on or before the
applicable due date shall bear interest at the rate of the Prime Rate, as
reported in the print edition of The Wall Street Journal, Eastern Edition, plus
two percent (2%), on the payment due date or, if unavailable, on the latest date
prior to the payment due date on which such rate is available, or the maximum
rate allowed by Law, whichever is less, calculated on a daily basis, based on
the actual number of days elapsed from the payment due date to the date of
actual payment.

4.6    Taxes    . The Company shall be responsible for all Taxes, if any,
imposed in connection with this Agreement or the performance of Services,
including any value added taxes, sales taxes, consumption taxes and other
similar Taxes on the provision or receipt of the Services hereunder, exclusive
of Taxes on Seller’s income. If Seller or any of its Affiliates are required to
pay such Taxes applicable to the Services, the Company shall promptly reimburse
Seller therefor. For the avoidance of doubt, the requirements of this Section
3.6 shall not apply to any employment-related taxes, income taxes or withholding
and shall only apply to Taxes applicable to the Services. The amounts payable by
the Company to Seller pursuant to this Agreement (“Payments”) shall not be
reduced on account of any Taxes unless required by Applicable Law. Seller alone
shall be responsible for paying any and all Taxes (other than withholding Taxes
required to be paid by Purchaser) levied on account of, or measured in whole or
in part by reference to, any Payments it receives. The Company shall deduct or
withhold from the Payments any Taxes that it is required by Applicable Law to
deduct or withhold; provided, however, if Seller is entitled under any
applicable Tax treaty to a reduction of rate of, or the elimination of, or
recovery of, applicable withholding Tax, it shall deliver to the Company or the
appropriate Governmental Entity (with the assistance of the Company to the
extent that this is reasonably required and is expressly requested in writing)
the prescribed forms necessary to reduce the applicable rate of withholding or
to relieve the Company of its obligation to withhold Tax, and the Company shall
apply the reduced rate of withholding, or dispense with the withholding, as the
case may be, to the extent it complies with the applicable Tax treaty. If, in
accordance with the foregoing, the Company withholds any amount, it shall make
timely payment to the proper Taxing Authority of the withheld amount, and send
to Seller proof of such payment within sixty (60) days following that payment.
The Company shall not change its domicile to a jurisdiction outside of the
United States or assign this Agreement to any Person that is domiciled outside
of the United States.

4.7    Records; Audit    .
4.7.1    Each Party shall keep and maintain, and shall cause its Affiliates to
keep and maintain, complete and accurate records and books of account
documenting all expenses and all other data necessary for the calculation of the
amounts payable to any other Party under this Agreement consistent with its
standard procedures and policies in the ordinary course of business for a period
of five (5) years after such expenses are incurred or, if longer, any retention
period required by Applicable Law. In the event of any inconsistency between
Section 2.12 and Section 3.7.1 regarding the document retention obligations of
Seller, Section 2.12 will govern.
4.7.2    Upon either Seller’s or the Company’s request, the other such Party
shall, and shall cause each of its Affiliates engaged in the performance of
activities under this Agreement to, permit the requesting Party and its
Representatives to audit the records and books of account maintained by it
pursuant to Section 3.7.1 in order to confirm the accuracy and completeness of
such records and books of account and all payments hereunder; provided, that no
Party shall be entitled to exercise its audit rights under this Section 3.7.2
more than once per Calendar Year, unless, in any case, any prior audit resulted
in an adjustment to amounts due or the Payments hereunder. The Party requesting
the audit shall bear all out-of-pocket costs and expenses incurred in connection
with any audit performed pursuant to this Section 3.7.2; provided, however, that
the audited Party shall reimburse the Party requesting the audit for all
reasonable costs and expenses incurred by such Party in connection with such
audit if any such audit identifies an underpayment to the auditing Party or an
overpayment to the audited Party hereunder in excess of 10% of the amounts
actually payable. In any case, the full amount of the underpayment or
overpayment as applicable shall be payable to the applicable Party plus accrued
interest at the rate set forth in Section 3.5.2. All information disclosed
pursuant to this Section 3.7.2 shall be subject to the non-disclosure and
non-use provisions set forth in Article 5.
4.7.3    Residual Pay-Off Amount. In connection with the Parties’ Pay-Off
Letter, dated March 16, 2018, relating to the Note (as defined in such Pay-Off
Letter), the Parties acknowledge and agree that the Pay-Off Amount (as defined
in such Pay-Off Letter) did not include any amounts payable for the performance
of the Initial Services under the Original Agreement from and after January 1,
2018. Accordingly, Seller shall invoice, and the Company shall pay such amounts
in accordance with this Agreement.

ARTICLE 5    
OWNERSHIP OF ASSETS: INTELLECTUAL PROPERTY AND RIGHTS OF REFERENCE; INVENTORY

5.1    Ownership    .
5.1.1    This Agreement and the performance of the Services hereunder shall not
affect the ownership of any Intellectual Property rights or other assets as set
forth in the Stock Purchase Agreement. For the avoidance of doubt, upon the
Closing, Seller shall not retain title to, or ownership rights in, the Company
or any Owned Intellectual Property or other assets of the Company, other than
the TSA Assets, the Prohibited Registered IP, the Seller Manufacturing
Technology, the Trademarks and certain domain names included in the Registered
IP (which, for the avoidance of doubt, shall be licensed and subsequently
transferred to the Company in accordance with Section 5.10(b), Section 5.10(c),
Section 5.10(f) and Section 5.10(g) of the Stock Purchase Agreement, as
applicable).
5.1.2    Except for any Seller Intellectual Property and any Third Party
Materials, any and all results, products, deliverables (interim or final),
reports, data (including raw data, processed data and data summaries), analyses
(including analyses of data), inventions, ideas, improvements, documents
(including CMC documents), discoveries, designs, drawings, protocols, processes,
techniques, formulae, trade secrets, materials, methods, procedures,
information, know-how, technology and other Intellectual Property that arise out
of, or result from or are derived from, any of the Services or the Ongoing
Trials, or that solely relate to the Compound or Products, including Ongoing
Trials Information and Documentation but excluding Seller Manufacturing
Technology (collectively, “Company Property”) shall be the sole and exclusive
property of Company and shall be deemed the Confidential Information of the
Company and subject to the confidentiality and non-use provisions of Article 5.
Seller shall fully disclose to the Company any and all Company Property, whether
conceived, reduced to practice, created, developed, derived, generated or
otherwise obtained by Seller or its Affiliates or its or their employees,
agents, consultants, subcontractors (including the Pass-Through Contractors) or
other representatives, alone or jointly with others, promptly upon obtaining or
becoming aware of the development, creation, generation, conception or reduction
to practice of such Company Property. To the extent any Company Property does
not constitute Company Intellectual Property or TSA Assets (which are assigned
or licensed to the Company pursuant to the Stock Purchase Agreement), Seller
hereby assigns, and shall cause its Affiliates and its and their employees and
subcontractors to assign, to Company all rights, title and interest in, to such
Company Property. Seller will, at the Company’s request and expense, perform any
and all acts necessary to assist the Company in preparing, filing any patent
applications and enforcing any patents covering such Company Property, or in
otherwise perfecting its rights thereto, without further compensation other than
reimbursement of Seller’s reasonable, documented out-of-pocket costs directly
and solely relating thereto.
5.1.3    Notwithstanding the foregoing, the Company acknowledges and agrees that
Seller and its Affiliates own and will retain all right, title and interest in
and to inventions, ideas, improvements, documents (including CMC documents),
discoveries, designs, drawings, protocols, processes, techniques, formulae,
trade secrets, materials, methods, procedures, information, know-how, technology
and other Intellectual Property (including Seller Manufacturing Technology) that
have been or will be developed by Seller or its Affiliates outside the scope of
this Agreement, but excluding Owned Intellectual Property and Product-Specific
Manufacturing Technology (collectively, “Seller Intellectual Property”). Seller
Intellectual Property shall also include all materials, documents, data
(including data contained in case report forms and all pharmacovigilance data
and safety database information), information, records and reports that are
generated, created, disclosed or learned by Seller in the conduct of the Ongoing
Trials to the extent such items are not included in the Ongoing Trials
Information or are otherwise not included in the Company Property. Seller shall
not, without the Company’s prior written consent, incorporate or integrate any
Seller Intellectual Property into any deliverables or other Company Property
except as required to perform the Services. Furthermore, Seller shall not,
without the Company’s prior written consent, knowingly incorporate or integrate
any materials, technology or Intellectual Property of any Third Party (“Third
Party Materials”) into any deliverables or other Company Property unless, prior
to incorporating such Third Party Materials, Seller shall have obtained from
such Third Party any and all rights necessary to enable Seller to perform its
obligations under this Agreement, including the granting of the rights as
provided in the next sentence. To the extent that Seller incorporates or
integrates Seller Intellectual Property or Third Party Materials into Company
Property, in order to provide Company freedom-to-operate with respect to Company
Property, Seller hereby grants to the Company a perpetual, assignable,
sublicensable through multiple tiers, non-exclusive, worldwide, royalty-free,
fully paid-up, irrevocable license under the Seller Intellectual Property and
under Seller’s rights, title and interest in and to the Third Party Materials
(to the extent permitted under any agreement between Seller or any of its
Affiliates and the applicable Third Party) to use, make, have made, sell, offer
for sale, import, reproduce, prepare derivative works of, display, distribute,
disclose or publish Company Property and to Exploit the Compound, Products and
otherwise conduct the Company Business.

5.2    Limited License    . Solely for and with respect to performance of
Services and other activities and obligations under this Agreement during the
Term, the Company (on behalf of itself and its Affiliates) hereby grants to
Seller and its Affiliates a non-exclusive, royalty-free, fully-paid up,
worldwide, non-transferable, sublicensable (without the consent of the Company
to any Third Party that performs Services for the benefit of Seller or its
Affiliates as of the Effective Date for the purpose of continuing the
performance of such Services and otherwise with the prior written consent of the
Company), license and right of reference to all Company Intellectual Property,
Company Property and all Drug Approval Applications owned by the Company (if any
during the Term), necessary or useful to perform the Services hereunder.

5.3    Inventory    . As of the Restated Effective Date, Seller, as directed by
the Company, has already delivered to the Company or any of its Affiliates
control of the existing inventory of packaged, unexpired Clinical Trial
Materials for the 310 and 311 studies. To the extent Seller possesses existing
bulk tablets of active and placebo Clinical Trial Materials that have not yet
expired, the Company shall bear all costs and expenses associated with delivery
of such inventory, which, to the extent incurred by Seller, shall be reimbursed
in accordance with Section 3.2. Nothing in this Agreement shall limit or alter
Seller’s obligations under the Supply Agreement, any future supply agreements
between the Parties, Work Order or any Change Order relating to chemistry,
manufacturing and controls (“CMC”) activities, including Seller’s obligations
relating to manufacture of stability samples and related activities and process
and manufacturing development.

ARTICLE 6    
CONFIDENTIALITY

6.1    Confidentiality Obligations    . Each of Seller and the Company shall,
and shall cause their respective Affiliates and Representatives to, keep
completely confidential and not publish, disclose or use, directly or
indirectly, for any purpose, any Confidential Information of the Disclosing
Party, except to the extent such disclosure or use is expressly permitted by the
terms of this Agreement (including pursuant to Section 5.2). “Confidential
Information” means the terms of this Agreement, the Original Agreement and any
information provided by or on behalf of Seller, on the one hand, or the Company,
on the other hand (in such capacity, a “Disclosing Party”) to the other (or to
any of the other’s Affiliates or Representatives) (collectively, in such
capacity, a “Receiving Party”) on or after the Effective Date in connection with
the Services, and shall include all memoranda, notes, analyses, compilations,
studies and other materials prepared by or for the Receiving Party to the extent
containing or reflecting such information; provided, however, that all Company
Property, including all Documentation and Ongoing Trials Information, shall be
the Confidential Information of the Company, and the Company shall be deemed the
Disclosing Party and Seller shall be deemed the Receiving Party of all Company
Property regardless of which Party generated, furnished or otherwise disclosed
the Company Property. Confidential Information shall not include any information
that the Receiving Party can establish by written documentation to:
(a)    have been publicly known prior to disclosure by the Disclosing Party or
its Affiliates or Representatives to the Receiving Party;
(b)    have become publicly known, without fault on the part of the Receiving
Party or the Receiving Party’s Representatives, subsequent to disclosure by the
Disclosing Party or its Affiliates or Representatives to the Receiving Party;
(c)    have been received by the Receiving Party at any time after the Effective
Date, other than in connection with the Services, from a source, other than the
Disclosing Party or the Disclosing Party’s Affiliates or Representatives,
lawfully having possession of and the right to disclose such Confidential
Information; or
(d)    have been otherwise known by the Receiving Party (based upon written
records of the Receiving Party) prior to disclosure by the Disclosing Party or
the Disclosing Party’s Affiliates or Representatives to the Receiving Party
(excluding Ongoing Trial Information, any information included in the TSA Assets
and the Manufacturing Technology).

6.2    Permitted Uses and Disclosures    . Each Receiving Party may use or
disclose Confidential Information of the Disclosing Party only as follows:
(a)    in responding to a valid order of a Governmental Entity having
jurisdiction or, if in the reasonable opinion of the Receiving Party’s legal
counsel, such disclosure is otherwise required by Law; provided, however, that
the Receiving Party shall first have given notice to the Disclosing Party and
given the Disclosing Party a reasonable opportunity to quash such order or to
obtain a protective order requiring that the Confidential Information and
documents that are the subject of such order be held in confidence by such
Governmental Entity or, if disclosed, be used only for the purposes for which
the order was issued (and, if requested by the Disclosing Party, the Receiving
Party shall have reasonably cooperated with the Disclosing Party in connection
with the foregoing); provided, further, that if a disclosure order is not
quashed or a protective order is not obtained, the Confidential Information
disclosed in response to such order shall be limited to that information that is
legally required to be disclosed in response to such order;
(b)    such Confidential Information may be (i) disclosed to any of the
Receiving Party’s Representatives, the Receiving Party’s Affiliates and such
Affiliates’ directors, officers and employees, in each case, who (A) has a need
to know such Confidential Information in connection with the Receiving Party’s
performance of its obligations or exercise of its rights or remedies under this
Agreement (the “Permitted Use”) and (B) is subject to obligations of
confidentiality and non-use with respect to such Confidential Information
substantially similar to the obligations of confidentiality and non-use of the
Receiving Party pursuant to this Article 5 and (ii) used solely for the
Permitted Use; provided, however, each Party shall be responsible for any
failure by any Person to whom it disclosed Confidential Information of the
Disclosing Party to comply with the confidentiality and use restrictions set
forth in this Article 5;
(c)    (i) the terms of this Agreement and the Original Agreement may be
disclosed and (ii) with the Disclosing Party’s prior written consent, such
Confidential Information may be disclosed, in either case ((i) or (ii)) to any
of the Receiving Party’s potential or actual Third Party providers of finance,
investors or acquirers as may be necessary or useful in connection with their
evaluation of such potential or actual financing transaction, investment or
acquisition, on the condition that any such Third Party is subject to
obligations of confidentiality and non-use with respect to such Confidential
Information substantially similar to the obligations of confidentiality and
non-use of the Receiving Party pursuant to this Article 5;
(d)    the Company shall have the right to disclose this Agreement and the
Original Agreement if required by the rules of a stock exchange on which the
Company’s securities are listed (or to which an application for listing has been
submitted), provided that the Company shall submit the proposed disclosure in
writing to Seller as far in advance as reasonably practicable so as to provide a
reasonable opportunity for Seller to comment thereon and the Company shall
accept any timely, reasonable comments provided by Seller thereon and use
commercially reasonable efforts to ensure the confidential treatment of any
portions of such proposed disclosure specified by Seller for redaction and
confidentiality; or
(e)    for the avoidance of doubt, the Company shall have the right to use and
disclose to any Third Party the Services to the extent reasonably necessary or
useful to exploit the Services for their intended use, and the Company shall
have the right to reproduce, prepare derivative works of, display, distribute,
disclose, publish, transfer, use and otherwise exploit any and all Company
Property.

6.3    Return or Destruction of Confidential Information    . Promptly following
the expiration or earlier termination of this Agreement or, upon the earlier
written request of a Disclosing Party, the applicable Receiving Party shall
destroy or return all documentary, electronic or other tangible embodiments of
the Disclosing Party’s Confidential Information to which the Receiving Party
does not retain rights hereunder and any and all copies thereof, including those
portions of any documents that incorporate or are derived from such Confidential
Information, and, in the case of destruction, provide a written certification of
such destruction, except that the Receiving Party may retain copies of any
Confidential Information to the extent required to (a) exercise any of its
rights or remedies or perform any of its obligations under this Agreement or (b)
comply with its established document retention and archiving policies.

6.4    Survival    . The provisions of this Article 5 shall survive for a period
of ten (10) years following the termination of this Agreement.

ARTICLE 7    
LIMITATION OF LIABILITY; INDEMNIFICATION

7.1    Other Agreements. Nothing in this Article 6 shall limit, alter or amend
the indemnification provisions in the Stock Purchase Agreement the Supply
Agreement, or any future supply agreements between the Parties.

7.2    Indemnification    .
7.2.1    Subject to this Article 6, the Company shall indemnify, defend and hold
harmless Seller and its Affiliates and their respective directors, officers,
shareholders, employees and agents (collectively, the “Seller Indemnitees”) from
and against, and reimburse and compensate them for, any and all Losses incurred
by any such Seller Indemnitees in connection with any suits, investigations,
claims or demands of Third Parties (collectively, “Third Party Claims”) arising
from or relating to (a) the breach of this Agreement by the Company or any of
its Affiliates or its or their subcontractors; or (b) the negligent act or
omission or willful misconduct of the Company or any of its Affiliates or its or
their subcontractors in connection with this Agreement; or (c) the performance
by Seller or any of its Affiliates or its or their subcontractors of Seller’s
obligations under and in accordance with the terms of this Agreement, except, in
each case, (i) for those Losses arising from Third Party Claims for which Seller
has an obligation to indemnify any Company Indemnitee pursuant to Section 6.2.2,
as to which Losses each of the Company and Seller shall indemnify the other
Party and the Seller Indemnitees or the Company Indemnitees, as applicable, to
the extent of its liability for such Losses, and (ii) that the Company shall
have no obligation to indemnify any Seller Indemnitee under this Section 6.2.1
for any Losses in connection with Third Party Claims arising from or relating to
any negligent act or omission of Seller or its Affiliates or subcontractors. In
addition, subject to this Article 6, the Company shall indemnify, defend and
hold harmless the Seller Indemnitees from and against, and reimburse and
compensate them for, any and all Losses incurred by any such Seller Indemnitees
in connection with any Third Party Claims arising from or relating to (x) any
action taken by Seller in connection with the Services at the specific request
of the Company or (y) any Regulatory Documentation, the form and content of
which have been approved by the Company, that is submitted to any regulatory or
governmental authority by the Seller in connection with the performance of the
Services (including any Third Party Claims that arise from or relate to the
labeling of a Product).
7.2.2    Subject to this Article 6, Seller shall indemnify, defend and hold
harmless the Company, Purchaser and their Affiliates and each of their
respective directors, officers, shareholders, employees and agents
(collectively, the “Company Indemnitees”) from and against any and all Losses
incurred by any such Company Indemnitees in connection with any Third Party
Claims arising from or relating to (a) the breach of this Agreement by Seller,
or any of its Affiliates or its or their subcontractors; or (b) the gross
negligence or willful misconduct of Seller or any of its Affiliates or its or
their subcontractors in connection with this Agreement, except, in each case,
for those Losses arising from Third Party Claims for which the Company has an
obligation to indemnify any Seller Indemnitee pursuant to Section 6.2.1(a) or
(b), as to which Losses each of the Company and Seller shall indemnify the other
Party and the Seller Indemnitees or the Company Indemnitees, as applicable, to
the extent of its liability for such Losses.
7.2.3    All indemnification claims made pursuant to this Section 6.2 shall be
governed by Section 8.03(a) of the Stock Purchase Agreement, mutatis mutandis.

7.3    Limitation of Liability    . TO THE FULLEST EXTENT PERMITTED BY
APPLICABLE LAW, EXCEPT IN CONNECTION WITH ACTUAL FRAUD AND THE PARTIES’
INDEMNIFICATION OBLIGATIONS UNDER SECTION 6.2, NEITHER THE COMPANY NOR SELLER
SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR SPECIAL, INDIRECT,
INCIDENTAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, FOR LOST OR
ANTICIPATED PROFITS, REVENUES OR OPPORTUNITIES OR FOR ANY DAMAGES CALCULATED BY
REFERENCE TO A MULTIPLIER OF REVENUE, PROFITS, EBITDA OR SIMILAR METHODOLOGY,
WHETHER OR NOT CAUSED BY OR RESULTING FROM THE ACTIONS OF SUCH PARTY OR THE
BREACH OF ITS COVENANTS, AGREEMENTS, REPRESENTATIONS OR WARRANTIES HEREUNDER AND
WHETHER OR NOT BASED ON OR IN WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE OR
STRICT LIABILITY) OR OTHERWISE. For clarity, Seller shall not be liable for the
acts or omissions of the Pass-Through Contractors (except to the extent arising
from or in connection with Seller’s or its Affiliates’ gross negligence, willful
misconduct or breach of this Agreement) and the liability of the Pass-Through
Contractors shall be as set forth in the Pass-Through Agreements; provided,
that, if the Company suffers any Losses with respect to which any Pass-Through
Contractor is obligated to indemnify, reimburse or compensate under any of the
Pass-Through Agreements, Seller shall, at the Company’s request, pursue a claim
for such indemnity, reimbursement or compensation and shall pay to the Company
any amounts that Seller receives from such Pass-Through Contractor on account of
such claim. The maximum aggregate liability of Seller and its Affiliates to the
Company or its Affiliates with respect to this Agreement and the Original
Agreement shall not, in the aggregate, exceed the aggregate amount of Services
Fees paid by the Company to Seller under the Agreement and the Original
Agreement; provided, however, that, the fact that the liability of Seller and
its Affiliates to the Company or its Affiliates with respect to this Agreement
or the Original Agreement exceeds the Services Fees paid by the Company to
Seller as of a particular time shall not preclude the Company or its Affiliates
from recovering against Seller and its Affiliates to the extent of additional
Services Fees paid after such time by the Company to Seller hereunder or
thereunder.

ARTICLE 8    
TERM AND TERMINATION

8.1    Term    . This Agreement shall commence on the Effective Date and shall
continue in full force and effect until the earliest of (a) the date on which
this Agreement is terminated in accordance with this Article 7; (b) the
expiration of the last Service Period, such that Seller is no longer obligated
to provide any Services pursuant to this Agreement; and (c) the termination by
the Company of the only remaining outstanding Service pursuant to Section 7.2.1,
such that Seller is no longer obligated to provide any Services pursuant to this
Agreement (the “Term”). For clarity, all obligations of Seller to provide to the
Company any Services under this Agreement shall cease at the end of the Term.
For the sake of clarity, with respect to Additional Services performed for the
NDA, the last Service Period shall end on June 30, 2018, unless extended upon
mutual written agreement of the Parties. With respect to Additional Services
performed for the Marketing Authorization Application to be submitted by the
Company to EMA for the Product (the “MAA”), the last Service Period shall end on
June 30, 2019.

8.2    Termination of Services    .
8.2.1    The Company may at any time prior to the end of the Term and upon sixty
(60) days’ prior written notice to Seller, terminate this Agreement in its
entirety or with respect to any Service, on a Service-by-Service basis,
whereupon, from and after the date of termination specified in such written
notice, Seller’s obligation to provide such Service(s) to the Company shall
cease and the Company shall have no obligation to pay Seller for such Service(s)
(other than with respect to those Services requested by the Company, and
performed by Seller or its Affiliates or subcontractors, and Out-of-Pocket Costs
incurred, or non-cancellable commitments made, prior to termination); provided,
that (a) if termination of any Service prevents Seller from providing any other
Service or Services (as reasonably determined by Seller), such other Service(s)
shall be deemed terminated and (b) if Seller reasonably determines that
termination of such Service would materially inhibit Seller from providing any
other Service or Services, Seller shall notify the Company in writing of such
determination within fifteen (15) days after Seller’s receipt of the Company’s
termination notice and, unless the Company withdraws its termination of such
Service within fifteen (15) days after the Company’s receipt of such notice by
Seller, such other Service(s) shall be deemed terminated.
8.2.2    In the event that either Seller or the Company materially breaches any
of its obligations, covenants, agreements, representations or warranties under
this Agreement (with the Party committing such material breach being referred to
herein as the “Breaching Party”), Seller (if the Company is the Breaching Party)
or the Company (if Seller is the Breaching Party) (the “Complaining Party”) may
terminate this Agreement upon sixty (60) days’ prior written notice (such sixty
(60)-day period, the “Notice Period”) to the Breaching Party, specifying the
breach and its claim of right to terminate; provided, that the termination of
this Agreement shall not become effective at the end of the Notice Period if (a)
the Breaching Party cures such breach during the Notice Period or (b) such
breach cannot be cured during the Notice Period and the Breaching Party
commences and diligently pursues actions to cure such breach within the Notice
Period, in which case the Breaching Party shall have an additional thirty
(30)-day period to cure such breach before such termination shall become
effective, provided, further, that any breach of a payment obligation hereunder
shall not be subject to extension in accordance with the preceding clause (b).
8.2.3    Each of the Company and Seller may terminate this Agreement immediately
upon written notice to the other Party if Seller or the Company, respectively,
(a) files in any court or with any other Governmental Entity, pursuant to any
Law of any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver or
trustee of that Party or of its assets; (b) proposes a written agreement of
composition or extension of its debts; (c) is served with an involuntary
petition against it, filed in any insolvency proceeding, and such petition is
not dismissed within sixty (60) days after the filing thereof; (d) consents to
the appointment or taking possession by a receiver, liquidator, assignee,
custodian, trustee, sequestrator (or similar official) of such Party or for any
substantial part of its property or makes any assignment for the benefit of
creditors; (e) admits in writing its inability to pay its debts generally as
they become due; or (f) has issued or levied against its property any judgment,
writ, warrant of attachment or execution or similar process that represents a
substantial portion of its property.
8.2.4    Each of the Company and Seller may terminate this Agreement to the
extent provided in Section 8.1.
8.2.5    This Agreement may be terminated upon the mutual written agreement of
the Company and Seller at any time.

8.3    Asset Transfer    . Upon termination or expiration of this Agreement, or
upon termination of any Service by the Company pursuant to Section 7.2.1, Seller
shall and shall cause its Affiliates to transfer and deliver to the Company,
within such time periods as Seller and the Company may reasonably agree, all
tangible TSA Assets and Company Property (or any portion thereof that pertains
to the applicable terminated Service), including all records, data, files and
other information and any work-in-process, received, generated or computed in
Seller’s performance of the Services during the Term, in electronic or hard copy
form; provided, however, that Seller shall not have any obligation to provide or
cause its Affiliates to provide data in any format other than the format in
which such data was originally generated or stored. Upon termination or
expiration of this Agreement, Seller shall not have any further obligation with
respect to any Services, or, except as expressly provided in this Agreement,
including this Section 7.3, any TSA Assets or Company Property, including any
obligation to facilitate the Company’s or any of its Affiliates’ performance,
use or maintenance of any Service or asset. Upon termination of any specific
Service by the Company pursuant to Section 7.2.1, Seller shall not have any
further obligation with respect to those specific Services that are terminated
pursuant to Section 7.2.1.

8.4    Accrued Rights    . Termination or expiration of this Agreement for any
reason shall be without prejudice to any rights that shall have accrued to the
benefit of a Party prior to such termination or expiration. Such termination or
expiration shall not relieve a Party from obligations that are expressly
indicated to survive the termination or expiration of this Agreement.

8.5    Surviving Obligations    . Without limiting the foregoing, Article 1,
Section 2.6, the last sentence of Section 2.8, Section 2.12, Section 2.15,
Article 3 (solely as it relates to Services performed, or Out-of-Pocket Costs or
Other Seller Costs incurred by Seller, in accordance with this Agreement prior
to termination or expiration of this Agreement), Article 4 (excluding Section
4.2), Article 5, Article 6, Section 7.3, Section 7.4, this Section 7.5 and
Article 8 shall survive the termination or expiration of this Agreement for any
reason.

ARTICLE 9    
MISCELLANEOUS

9.1    Force Majeure    . Except for the obligation to pay monies due and owing,
neither Party shall be liable for any failure to perform or any delays in
performance, and no such Party shall be deemed to be in breach or default of its
obligations set forth in this Agreement, if, to the extent and for so long as,
such failure or delay is due to any causes that are beyond such Party’s
reasonable control and without its fault or negligence, including, without
limitation, such causes as acts of God, natural disasters, fire, flood, severe
storm, earthquake, civil disturbance, lockout, riot, order of any court or
administrative body, embargo, acts of government, war (whether or not declared),
acts of terrorism, or other similar causes (“Force Majeure Event”). In the event
of a Force Majeure Event, Seller or the Company, if prevented from or delayed in
performing, shall promptly give notice to the other such Party and shall use
commercially reasonable efforts to avoid or minimize the delay. In the event
that the delay continues for a period of at least thirty (30) days, the other
such Party may elect to (a) suspend performance and extend the time for
performance for the duration of the Force Majeure Event, or (b) terminate this
Agreement without any liability to any Party.

9.2    Independent Contractor    . The Parties and each of their respective
Affiliates shall each be an independent contractor in the performance of its
obligations hereunder. No Third Party, including any employee of any Party or
any of such Party’s Affiliates, shall have or acquire any rights by reason of
this Agreement.

9.3    Assignment    . Neither this Agreement nor any of the rights or
obligations of the Parties hereunder may be assigned by the Company, on the one
hand, or Seller, on the other hand, without the prior written consent of Seller
(in the case of the Company) or the Company (in the case of Seller), as
applicable; provided, however, that subject to Section 3.6 (a) the Company, on
the one hand, and Seller, on the other hand, may assign or delegate any or all
of its rights or obligations hereunder to an Affiliate without the prior written
consent of the other Party, and (b) the Company may assign this Agreement to a
successor to all or substantially all of the assets or business of the Company
to which this Agreement relates, whether in a merger, sale of stock, sale of
assets or otherwise. Subject to the first sentence of this Section 8.3, this
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective successors and permitted assigns. Any attempted assignment or
transfer in violation of this Section 8.3 shall be null and void.

9.4    No Benefit to Third Parties    . Except for the rights of any indemnified
Person under Article 6, and as it relates to the Company, with the exception of
Dova Pharmaceuticals, Inc. and Dova Pharmaceuticals Ireland Limited, this
Agreement is for the sole benefit of the Parties and their respective successors
and permitted assigns and nothing herein expressed or implied shall give or be
construed to give to any Person, other than the Parties and such successors and
assigns, any legal or equitable rights hereunder; provided, that,
notwithstanding anything herein to the contrary, as among the Company, Dova
Pharmaceuticals, Inc. and Dova Pharmaceuticals Ireland Limited, only Dova
Pharmaceuticals Inc. shall have the right to give any Notice or provide any
correspondence in connection with this Agreement to Seller or any of its
Affiliates.

9.5    Notices    .
9.5.1     Any notice, request, demand, waiver, consent, approval or other
communication permitted or required under this Agreement (each, a “Notice”)
shall be in writing, shall refer specifically to this Agreement and shall be
deemed given only if delivered by hand or sent by email as a PDF attachment
(with transmission confirmed by non-automated reply email from the recipient,
provided, that any Notice received by e-mail transmission or otherwise at the
addressee’s location on any Business Day after 5:00 p.m., Washington, D.C. time
shall be deemed to have been received at 9:00 a.m., Washington, D.C. time on the
next Business Day) or by internationally recognized overnight delivery service
that maintains records of delivery, addressed to the Parties at their respective
addresses specified in this Section 8.5 or to such other address as the Party to
whom notice is to be given may have provided to the Party giving the Notice at
least ten (10) days’ prior to such address taking effect in accordance with this
Section 8.5. Such Notice shall be deemed to have been given as of the date
delivered by hand or internationally recognized overnight delivery service or
confirmed that it was received by email. Any Notice delivered by email shall be
confirmed by a hard copy delivered as soon as practicable thereafter.
(i)
If to Seller, to:

Eisai Inc.
100 Tice Blvd.
Woodcliff Lake, New Jersey 07677
Facsimile: (201) 746-3204
Attention: General Counsel
with a copy (which shall not constitute notice) to:
Covington & Burling LLP
One CityCenter
850 Tenth Street, NW
Washington, D.C. 20001
Attention: Michael J. Riella
Facsimile: (202) 662-6291
E-mail: mriella@cov.com
(ii)
If to the Company, to:

Dova Pharmaceuticals, Inc.
On behalf of AkaRx, Inc.
240 Leigh Farm Road, Suite 245
Durham, North Carolina 27707
Attention: Chief Executive Officer
with a copy (which shall not constitute notice) to:
Dova Pharmaceuticals, Inc.
240 Leigh Farm Road, Suite 245
Durham, North Carolina 10036
Attention: General Counsel

9.6    Severability    . If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any present or future Law, and if the
rights or obligations of any Party under this Agreement will not be materially
and adversely affected thereby, (a) such provision shall be fully severable, (b)
this Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Company and Seller.

9.7    Governing Law    . This Agreement, the negotiation, execution or
performance of this Agreement and any disputes arising under or related hereto
(whether for breach of contract, tortious conduct or otherwise) shall be
governed and construed in accordance with the Laws of the State of Delaware,
without reference to its conflicts of law principles that would result in the
application of the substantive Law of any other jurisdiction.

9.8    Jurisdiction    . Each Party irrevocably agrees that any action, suit or
proceeding against it arising out of or in connection with this Agreement or
disputes relating hereto (whether for breach of contract, tortious conduct or
otherwise) shall be brought exclusively in the Court of Chancery of the State of
Delaware or, solely if such court lacks subject matter jurisdiction, the United
States District Court sitting in New Castle County in the State of Delaware, and
the appellate courts having jurisdiction thereover (collectively, the “Chosen
Courts”), and hereby irrevocably accepts and submits to the exclusive
jurisdiction and venue of the Chosen Courts in personam with respect to any such
proceeding and waives to the fullest extent permitted by Law any objection that
it may now or hereafter have that any such proceeding has been brought in an
inconvenient forum.

9.9    Service of Process    . Each of the Parties consents to service of any
process, summons, notice or document which may be served in any proceeding in
the Chosen Courts, which service may be made by certified or registered mail,
postage prepaid, or as otherwise provided in Section 8.5, to such Party’s
address set forth in Section 8.5.

9.10    Waiver of Jury Trial    . EACH PARTY HEREBY IRREVOCABLY WAIVES, TO THE
FULLEST EXTENT PERMITTED BY LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN
RESPECT TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN
CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR
DISPUTES RELATING HERETO. EACH PARTY (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT
OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT
SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE
FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE
BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL
WAIVERS AND CERTIFICATIONS IN THIS SECTION 8.10.

9.11    Amendments and Waivers    . This Agreement may be amended, modified,
superseded or canceled and any of the terms or conditions hereof may be waived
only by an instrument in writing signed by each of the Company and Seller or, in
the case of a waiver, by or on behalf of the Party waiving compliance. No course
of dealing between the Parties shall be effective to amend or waive any
provision of this Agreement. The waiver by a Party of any right hereunder or of
the failure to perform or of a breach by any other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by such
other Party whether of a similar nature or otherwise. The rights and remedies
provided herein are cumulative and do not exclude any other right or remedy
provided by applicable Law or otherwise available except as expressly set forth
herein.

9.12    Joint Drafting    . The Parties have participated jointly in the
negotiation and drafting of this Agreement. In the event an ambiguity or
question of intent or interpretation arises, this Agreement shall be construed
as if drafted jointly by the Parties and no presumption or burden of proof shall
arise favoring or disfavoring any Party by virtue of the authorship of any of
the provisions of this Agreement.

9.13    Obligations    . To the extent any Affiliate of Seller will perform any
Services or other obligations of Seller hereunder, Seller shall take any and all
action necessary to cause such Affiliate to perform and fulfill Seller’s
covenants, obligations and agreements under this Agreement, and shall be
primarily responsible for any breach of this Agreement by such Affiliate.

9.14    Counterparts    . This Agreement may be executed in any number of
counterparts, and each such counterpart hereof shall be deemed to be an original
instrument, but all such counterparts together shall constitute but one
agreement. Delivery of an executed counterpart of a signature page of this
Agreement by facsimile or other electronic transmission shall be effective as
delivery of a manually executed original counterpart of this Agreement.

9.15    Entire Agreement    . This Agreement, together with Stock Purchase
Agreement, the Schedules and Exhibits expressly contemplated hereby and attached
hereto, the Confidentiality Agreement, the other Ancillary Agreements and the
other agreements, certificates and documents delivered in connection with the
Stock Purchase Agreement or therewith or otherwise in connection with the
transactions contemplated hereby and thereby, contain the entire agreement among
the Parties with respect to the transactions contemplated hereby or thereby and
supersede all prior agreements, understandings, promises and representations,
whether written or oral, between the Parties with respect to the subject matter
hereof and thereof.

9.16    Dispute Resolution. Except for Invoice Disputes (which shall be resolved
pursuant to Section 3.5.1), if a dispute arises between the Parties in
connection with or relating to this Agreement or any document or instrument
delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to
this Section 8.16.
9.16.1    Either Party shall have the right to refer any Dispute to the
President and Chief Executive Officer of Seller (or his or her designee with
authority to resolve such Dispute) and the President and Chief Executive Officer
of the Company who shall confer on the resolution of the issue. Any final
decision mutually agreed to by such officers shall be conclusive and binding on
the Parties. If such officers are not able to agree on the resolution of any
such issue within fifteen (15) Business Days after such Dispute is first
referred to them, either Party may, by written notice to the other Party, elect
to initiate litigation in accordance with Section 8.7, Section 8.8 and Section
8.9 for purposes of having the matter settled.
9.16.2    Notwithstanding anything herein to the contrary, (a) any relevant time
period related to a matter that is the subject of a Dispute shall be tolled
during any dispute resolution proceeding under this Section 8.16 and (b) nothing
in this Section 8.16 shall preclude either Party from seeking interim or
provisional relief, including a temporary restraining order, preliminary
injunction or other interim equitable relief concerning a Dispute, if necessary
to protect the interests of such Party. This Section 8.16 shall be specifically
enforceable.
[Signature page follows]

IN WITNESS WHEREOF, Seller and the Company have duly executed this Agreement as
of the date first written above.
Eisai Inc.

By: /s/ Shaji Procida    
Name: Shaji Procida
Title: President and COO

AkaRx, Inc.

By: /s/ Mark Hahn    
Name: Mark Hahn
Title: CFO
 

Schedule 2.1

Initial Work Order
[***]

•

Schedule 2.2

Additional Work Order
[***]
•    

Schedule 2.4.2

PART A
Key Employees for Initial Services

[***]

PART B
Key Employees for Additional Services

[***]

EXHIBIT A

Pass-Through Agreements
1.
See Items 3-37 in Section 3.10(a) of the Seller Disclosure Schedule.

2.
Master Services Agreement, dated December 23, 2010, between Eisai Limited and
Phlexglobal Limited.

3.
Development and Manufacturing Services Agreement, dated October 29, 2012,
between Eisai Pharmatechnology and Manufacturing Pvt. Ltd. and Civentichem India
Pvt. Ltd.  

EXHIBIT B
Form of Seller IND Transfer Letter
[                              ]
Food and Drug Administration
5901-B Ammendale Road
Beltsville, MD  20705-1266
 
Re:
 
Investigational New Drug Application #062122/#075537/#076680
 
 
Change in Ownership and Official Correspondent
Product:
 
Avatrombopag Maleate

 
Dear [                 ]:
 
Reference is made to Investigational New Drug Application
#062122/#075537/#076680 for Avatrombopag (the “IND”).  The purpose of this
submission is to inform the Food and Drug Administration (the “Agency”) that the
ownership of the IND is being transferred from Eisai Inc., 155 Tice Blvd.,
Woodcliff Lake, NJ to [the Company],[            ].
 
In accordance with 21 CFR 314.72, Eisai Inc. hereby notifies the Agency that
effective [            ], all rights to the IND have been transferred to [the
Company].  [The Company’s] letter confirming acceptance of the IND transfer will
be submitted as sequence no. [            ].  [The Company] has been provided
with a complete copy of the IND, including amendments and records required to be
kept under 21 CFR § 314.72.  As of the date hereof, [the Company] assumes all
regulatory responsibility for the IND and all agreements, regulatory
obligations, promises and conditions contained therein.
 
All correspondence for this application should be sent to:
 
[            ] (primary contact)
Email: [            ]
Telephone: [            ]
Facsimile: [            ]
 
[            ] (alternate contact)
Email: [            ]
Telephone: [            ]
Facsimile: [            ]
 
All electronic files included in this submission are <10 MB.  All files were
checked and verified to be free of viruses before submitting via the Gateway
using Symantec Endpoint Protection, program versions available upon request. 
For technical questions regarding the electronic submission, please contact
[Sung-Jun Ahn at 201-949-4531].
 
If you have any questions regarding this submission, please contact me at the
number below.
 
Sincerely,
Eisai Inc.
 
[Stacie P. O’Sullivan
Associate Director, Global Regulatory Affairs
Office:  410-631-8138
Email:  Stacie_osullivan@eisai.com]
•    

ii
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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

Schedule 2.1 - iii

EXHIBIT C

Form of Company IND Transfer Letter
[                                  ]
Food and Drug Administration
5901-B Ammendale Road
Beltsville, MD  20705-1266
 
Re:
 
Investigational New Drug Application #062122/#075537#076680
 
 
Change in Ownership — Acceptance
Product:
 
Avatrombopag Maleate

 
Dear [                       ]:
 
Reference is made to Investigational New Drug Application
#062122/#075537/#076680 for Avatrombopag (the “IND”).  The purpose of this
submission is to inform the Food and Drug Administration (the “Agency”) that the
ownership of the IND is being transferred from Eisai Inc., 155 Tice Blvd.,
Woodcliff Lake, NJ to [the Company],[            ].  Reference is also made to
the enclosed letter from Eisai Inc., dated [           sequence no._]
transferring ownership and official correspondent of the IND to [the Company].
 
In accordance with 21 CFR 314.72, [the Company] hereby accepts the change in
ownership which is effective as of [            ].  [The Company] has a complete
copy of the IND including amendments and records that are required under 21 CFR
314.81 and commits to the agreements, promises and conditions made by the former
owner and contained in the application.
 
Also enclosed is a revised 1571 form.  Please direct all the IND-related
correspondence to the following primary and alternate contacts at [the Company]:
 
[            ] (primary contact)
Email: [            ]
Telephone: [            ]
Facsimile: [            ]
 
[            ] (alternate contact)
Email: [            ]
Telephone: [            ]
Facsimile: [            ]
 
[            ]
[            ]
[            ]
 
If you have any questions, please contact me at [            ] or by phone at
[            ].  Alternatively, you may contact [            ] at [            ]
or at [            ].
 
Sincerely,
 
[            ]
[            ]
 
Cc: [            ]

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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

Schedule 2.1 - iv

[            ]
 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.