Exhibit 10.1

 

 

 

 

 

 

 

 

Asset Purchase Agreement

by and between

Gilead Sciences, Inc.

and

Sarepta Therapeutics Inc.

 

 

February 20, 2017

 

 

 

 

 

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Asset Purchase Agreement

 

This Asset Purchase Agreement (this “Agreement”) is made and entered into as of
February 20, 2017 (the “Effective Date”), by and between GILEAD SCIENCES, INC.,
a corporation organized under the laws of the Delaware (“Buyer”), and SAREPTA
THERAPEUTICS INC., a corporation organized under the laws of Delaware
(“Seller”). Buyer and Seller may hereinafter be referred to individually as a
“Party” and collectively as the “Parties”.

RECITALS

WHEREAS, Seller is the holder of all right, title and interest in and to the
Priority Review Voucher (as defined below).

Whereas, Seller and Buyer each (i) desire that Buyer purchase from Seller, and
Seller sell, transfer and assign to Buyer, the Purchased Assets (as defined
below), all on the terms set forth herein (such transaction, the “Asset
Purchase”) and (ii), in furtherance thereof, have duly authorized, approved and
executed this Agreement and the other transactions contemplated by this
Agreement in accordance with all applicable Legal Requirements (as defined
below).

Whereas, Seller and Buyer desire to make certain representations, warranties,
covenants and other agreements in connection with the Asset Purchase as set
forth herein.

NOW, THEREFORE, in consideration of the foregoing and their mutual undertakings
hereinafter set forth, and intending to be legally bound, the Parties hereto
agree as follows:

ARTICLE I
DEFINITIONS

1.1Certain Definitions. As used in this Agreement, the following terms shall
have the meanings indicated below:

(a)“Affiliate” means any Person which, directly or indirectly through one or
more intermediaries, controls, is controlled by or is under common control with
a Party to this Agreement, for so long as such control exists, whether such
Person is or becomes an Affiliate on or after the Effective Date.  A Person
shall be deemed to “control” another Person if it: (i) with respect to such
other Person that is a corporation, owns, directly or indirectly, beneficially
or legally, at least fifty percent (50%) or more of the outstanding voting
securities or capital stock (or such lesser percentage which is the maximum
allowed to be owned by such Person in a particular jurisdiction) of such other
Person, or, with respect to such other Person that is not a corporation, has
other comparable ownership interest; or (ii) has the power, whether pursuant to
contract, ownership of securities or otherwise, to direct the management and
policies of such other Person.

(b)“Business Day” means a day (i) other than Saturday or Sunday and (ii) on
which commercial banks are open for business in New York, New York.

(c)“Confidential Information” means (i) any and all confidential and proprietary
information, including but not limited to, data, results, conclusions, know-how,
experience, financial information, plans and forecasts, that may be delivered,
made available, disclosed or communicated by a Party or its Affiliates or their
respective Representatives to the other Party or its Affiliates or their
respective Representatives, related to the subject matter hereof or otherwise in
connection with this Agreement and (ii) the terms, conditions and existence of
this Agreement. “Confidential Information”

 

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will not include information that (A) at the time of disclosure, is generally
available to the public, (B) after disclosure hereunder, becomes generally
available to the public, except as a result of a breach of this Agreement by the
recipient of such information, (C) becomes available to the recipient of such
information from a Third Party that is not legally or contractually prohibited
by the disclosing Party from disclosing such Confidential Information; or (D)
was developed by or for the recipient of such information without the use of or
reference to any of the Confidential Information of the disclosing Party or its
Affiliates, as evidenced by the recipient’s contemporaneous written
records.  Notwithstanding anything herein to the contrary, all Confidential
Information included within the Purchased Assets shall constitute Confidential
Information of the Buyer from and after the Closing Date.

(d)“Contract” means any written or oral legally binding contract, agreement,
instrument, commitment or undertaking (including leases, licenses, mortgages,
notes, guarantees, sublicenses, subcontracts and purchase orders).

(e)“Encumbrance” means any lien, pledge, charge, mortgage, easement,
encroachment, imperfection of title, title exception, title defect, right of
possession, lease, security interest, encumbrance, adverse claim, interference
or restriction on use or transfer.  

(f)“FDA” means the United States Food and Drug Administration.

(g)“FDCA” means the United States Federal Food, Drug, and Cosmetic Act, as
amended.

(h)“Governmental Entity” means any supranational, national, state, municipal,
local or foreign government, any court, tribunal, arbitrator, administrative
agency, commission or other governmental official, authority or instrumentality,
in each case whether domestic or foreign, any stock exchange or similar
self‑regulatory organization or any quasi‑governmental or private body
exercising any regulatory, taxing or other governmental or quasi‑governmental
authority.

(i)“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, and the rules and regulations promulgated thereunder.

(j)“Legal Requirements” means any federal, state, foreign, local, municipal or
other law, statute, constitution, principle of common law, resolution,
ordinance, code, rule, regulation, ruling or requirement issued, enacted,
adopted, promulgated, implemented or otherwise put into effect by or under the
authority of any Governmental Entity and any Orders applicable to a Party or to
any of its assets, properties or businesses.  Legal Requirements shall include,
with respect to Seller, any responsibilities, requirements, parameters and
conditions relating to the Priority Review Voucher set forth in the NDA 206488
approval letter from the Department of Health and Human Services to Seller,
Reference ID 3987286, regarding approval of the Subject NDA (as defined below).

(k)“Liabilities” means all debts, liabilities and obligations, whether presently
in existence or arising hereafter, accrued or fixed, absolute or contingent,
matured or unmatured, determined or determinable, asserted or unasserted, known
or unknown, including those arising under any law, action or governmental order
and those arising under any Contract.

(l)“Order” means any order, decree, edict, injunction, writ, award or judgment
of any Governmental Entity.

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(m)“Person” means any natural person, company, corporation, limited liability
company, general partnership, limited partnership, trust, proprietorship, joint
venture, business organization or Governmental Entity.

(n)“Priority Review” means a priority review of and action upon a human drug
application by the FDA not later than six (6) months after the filing of such
application to the FDA, as defined in the FDCA (21 U.S.C. 360ff(a)(1)).

(o)“Priority Review Voucher” means the priority review voucher issued by the
United States Secretary of Health and Human Services, Food and Drug
Administration, to Seller, as evidenced in the U.S. Federal Register by the
notice set forth at
https://www.federalregister.gov/documents/2016/10/17/2016-24947/issuance-of-priority-review-voucher-rare-pediatric-disease-product
(81 Federal Register 8171511) for tracking number PRV NDA 206488, as the sponsor
of a rare pediatric disease product application, that entitles the holder of
such voucher to Priority Review of a single human drug application submitted
under Section 505(b)(l) of the FDCA or a single biologic application submitted
under Section 351 of the Public Health Service Act, as further defined in the
FDCA (21 U.S.C. 360ff(a)(2)).

(p)“Proceeding” means any action, arbitration, audit, hearing, investigation,
proceeding, litigation or suit (whether civil, criminal, administrative,
judicial or investigative, whether formal or informal, whether public or
private) commenced, brought, conducted or heard by or before, or otherwise
involving, any Governmental Entity or arbitrator.

(q)“Purchased Assets” means (i) the Priority Review Voucher, and (ii) any and
all rights, benefits and entitlements afforded to the holder of the Priority
Review Voucher.

(r)“Regulatory Change” means any (i) new Legal Requirement, amendment or
supplement to any then-existing Legal Requirement enacted, adopted or approved
by any Governmental Entity in the United States, or (ii) term or condition
imposed by the FDA on the Priority Review Voucher that is not generally imposed
on priority review vouchers under the FDCA as of the Effective Date, that in
either case (i) or (ii) has been enacted, adopted, approved or imposed between
the Effective Date and the Closing Date and adversely impacts the manner in
which Buyer may use, receive, hold or otherwise exploit the Priority Review
Voucher.

(s)“Representative” means, with respect to a particular Person, any director,
officer, manager, employee, agent, consultant, advisor, accountant, financial
advisor, legal counsel or other representative of that Person.

(t)“Subject NDA” means NDA 206488 for Exondys 51 (eteplirsen) Injection, 50mg
per mL.

(u)“Third Party” means any Person other than a Party and such Party’s
Affiliates.

Other capitalized terms defined elsewhere in this Agreement and not defined in
this Section 1.1 shall have the meanings assigned to such terms in this
Agreement.

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ARTICLE II
PURCHASE AND SALE

2.1Purchase and Sale; No Assumed Liabilities.

(a)Upon the terms and subject to the conditions of this Agreement, Buyer agrees
to purchase from Seller, and Seller agrees to sell, transfer, convey, assign and
deliver to Buyer, at the Closing all of Seller’s right, title and interest in,
to and under the Purchased Assets, in each case free and clear of all
Encumbrances.

(b)For the avoidance of doubt, (i) the sale, assignment, transfer and conveyance
of the Purchased Assets from Seller to Buyer shall not include the transfer,
conveyance or assumption of any Liabilities from Seller to Buyer, and (ii) Buyer
shall not assume or be liable for any Liabilities of Seller or its Affiliates
(fixed, contingent or otherwise, and whether or not accrued), including
Liabilities relating to the Purchased Assets (other than such obligations as are
imposed generally by applicable Legal Requirements solely on the holder of the
Priority Review Voucher in respect of its use or transfer following the sale
thereof pursuant to this Agreement) (such Liabilities, “Excluded Liabilities”).

2.2Purchase Price.  The total consideration (the “Purchase Price”) to be paid by
Buyer to Seller for all of the Purchased Assets shall be One Hundred and Twenty
Five Million Dollars (U.S. $125,000,000) due and payable upon the Closing Date.

2.3Method of Payment.  Payment of the Purchase Price to Seller shall be made in
cash by wire transfer of immediately available funds to a bank account specified
by Seller in writing to Buyer in the form of Valid Account Details no later than
five (5) Business Days prior to the Closing Date. “Valid Account Details” means,
with respect to any bank account, the valid (a) name of bank, (b) bank’s
address, (c) account number, (d) account name and (e) ABA/Routing number.

2.4Tax Withholding.  If any Legal Requirement requires deductions from, or that
taxes be withheld on, payment of the Purchase Price, Buyer shall deduct or
withhold such amounts from the Purchase Price and pay the applicable amount to
the proper Governmental Entity.  To the extent any such withheld amounts are
subject to refund or credit, upon Seller’s reasonable request Buyer shall
cooperate, including completion and submission of any related documentation or
filings, to assist Seller in obtaining any such refund or credit.  Seller shall
provide a complete and executed Form W-9 that certifies Seller’s eligibility for
reduced or non-withholdings no later than five (5) Business Days prior to the
Closing Date.

ARTICLE III
CLOSING

3.1Closing.  The consummation of the purchase and sale transaction contemplated
by this Agreement (the “Closing”) shall be conducted telephonically or via
email, facsimile transfer or other similar means of correspondence on such date
to be mutually agreed upon by Buyer and Seller, which date shall be no later
than the third (3rd) Business Day after all of the conditions set forth in
ARTICLE VI have been satisfied or waived (other than those conditions which, by
their terms, are intended to be satisfied at the Closing, but subject to
satisfaction or waiver of such conditions). The date on which the Closing
actually takes place is referred to in this Agreement as the “Closing Date”.

3.2Transactions to be Effected at Closing. At the Closing,

(a)Seller shall deliver, or cause to be delivered, to Buyer an executed Bill of
Sale substantially in the form attached hereto as Exhibit A;

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(b)Seller shall deliver, or cause to be delivered, to Buyer an executed
certificate from a duly authorized officer of the Seller certifying as to the
matters set forth in Section 6.2(c);

(c)Buyer shall deliver, or cause to be delivered, to Seller an executed
certificate from a duly authorized officer of the Buyer certifying as to the
matters set forth in Section 6.3(c);

(d)Seller shall deliver, or cause to be delivered, to Buyer an executed
certificate of the secretary or an assistant secretary (or equivalent duly
authorized officer or other representative) of Seller certifying (i) that
attached thereto are true and complete copies of all resolutions adopted by the
board of directors of Seller authorizing the execution, delivery and performance
of this Agreement and the consummation of the transactions contemplated hereby,
and that all such resolutions are in full force and effect and are all the
resolutions adopted in connection with the transactions contemplated hereby, and
(ii) as to the incumbency of each person executing this Agreement and any other
document delivered in connection herewith on behalf of Seller and that the
signature of each such person on this Agreement and such other document is such
person’s genuine signature;

(e)Buyer shall pay the Purchase Price to Seller by wire transfer of immediately
available funds to an account or accounts designated in writing by Seller to
Buyer in the form of Valid Account Details, such designation to occur at least
five (5) Business Days prior to the Closing Date;

(f)Seller shall submit to the FDA (in the form of a submission to the Subject
NDA) and deliver to Buyer a letter addressed to Buyer, substantially in the form
set forth on Exhibit B hereto and duly executed by Seller, acknowledging the
transfer of the Priority Review Voucher from Seller to Buyer, in accordance with
applicable Legal Requirements; and

(g)Buyer shall submit to the FDA (in the form of a submission to the Subject
NDA) and deliver to Seller a letter addressed to Seller, substantially in the
form set forth on Exhibit C hereto and duly executed by Buyer, acknowledging the
transfer of the Priority Review Voucher from Seller to Buyer, in accordance with
applicable Legal Requirements.

3.3Title Passage. Upon the Closing, all of the right, title and interest of
Seller in and to the Purchased Assets shall pass to Buyer.

ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF SELLER

Seller represents and warrants to Buyer, as of the Effective Date and the
Closing Date, as follows:

4.1Organization, Standing and Power.  Seller is a corporation duly organized and
validly existing under the laws of the State of Delaware.  Seller has the
corporate power and authority to own, operate and lease its properties and to
carry on its business as presently conducted and is duly qualified or licensed
to do business and is in good standing in each jurisdiction where the character
of its properties owned or leased or the nature of its activities make such
qualification or licensing necessary, except where the failure to be so
qualified or licensed would not, individually or in the aggregate, reasonably be
expected to adversely affect any of the Purchased Assets or Seller’s ability to
consummate the transactions contemplated by this Agreement.  Seller is not in
violation of its certificate of incorporation or bylaws, in each case as amended
to date.

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4.2Due Authority.  Seller has the requisite corporate power and authority to
enter into and perform its obligations under this Agreement. The execution,
delivery and performance of this Agreement, and the consummation of the Asset
Purchase, have been duly and validly approved and authorized by all necessary
corporate action on the part of Seller, and this Agreement has been duly
executed and delivered by Seller.  This Agreement, upon execution by the
Parties, will constitute a valid and binding obligation of Seller enforceable
against Seller in accordance with its terms, subject only to the effect, if any,
of (a) applicable bankruptcy and other similar laws affecting the rights of
creditors generally and (b) rules of law governing specific performance,
injunctive relief and other equitable remedies.  The approval of Seller’s
stockholders is not required for the execution, delivery and performance of this
Agreement, and the consummation of the Asset Purchase.

4.3Noncontravention.  The execution and delivery by Seller of this Agreement
does not, and the consummation of the transactions contemplated hereby,
including the transfer of title to, ownership in, and possession of the
Purchased Assets, will not, (a) result in the creation of any Encumbrance on any
of the Purchased Assets or (b) conflict with, or result in any violation of or
default under (with or without notice or lapse of time, or both), or give rise
to a right of termination, cancellation or acceleration of any obligation or
loss of any benefit under, or require any consent, approval or waiver from any
Person pursuant to, (i) any provision of the certificate of incorporation or
bylaws of Seller, in each case as amended to date, (ii) any Contract to which
Seller is a party or by which it is bound which involves or affects in any way
any of the Purchased Assets or (iii) except as may be required to comply with
the HSR Act, any Legal Requirements applicable to Seller or any of the Purchased
Assets.

4.4No Consents. Except for the letters referenced in Sections 3.2(d) and 3.2(e)
and the filing of a Premerger Notification and Report Form under the HSR Act, no
filing, authorization, consent, approval, permit, order, registration or
declaration, governmental or otherwise, is necessary to enable or authorize
Seller to enter into, and to perform its obligations under, this Agreement.

4.5Title to Purchased Assets.  Seller is the sole and exclusive owner of the
Purchased Assets and owns and at the Closing will transfer to Buyer good and
transferable title to the Purchased Assets free and clear of any Encumbrances.
Seller has performed all actions necessary to perfect its ownership of, and its
ability to transfer, the Purchased Assets pursuant to this Agreement.  Seller
has provided to Buyer a true, correct and complete copy of the Priority Review
Voucher.

4.6Contracts.  Except for this Agreement, there is no Contract to which Seller
or any Affiliate of Seller is a party that involves or affects the ownership of,
licensing of, title to, or use of any of the Purchased Assets.

4.7Compliance With Legal Requirements.  Seller and its Affiliates are, and at
all times have been, in full compliance with each Legal Requirement that is or
was applicable to (a) Seller’s and its Affiliates’ conduct, acts, or omissions
with respect to any of the Purchased Assets or (b) any of the Purchased
Assets.  Seller and its Affiliates have not received any notice or other
communication (whether oral or written) from any Person regarding any actual,
alleged, possible or potential violation of, or failure to comply with, any such
Legal Requirement.

4.8Legal Proceedings.  There is no pending, or to Seller’s knowledge, threatened
Proceeding that involves or affects (or may involve or affect) the ownership of,
licensing of, title to, or use of any of the Purchased Assets.  None of the
Purchased Assets are subject to any Order of any Governmental Entity or
arbitrator.

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4.9Governmental Authorizations. Seller is not required to hold any license,
registration, or permit issued by any Governmental Entity to own, use or
transfer the Purchased Assets, other than such licenses, registrations or
permits that have already been obtained.

4.10Solvency.  Seller is not entering into this Agreement with the actual intent
to hinder, delay, or defraud any creditor of Seller.  The remaining assets of
Seller after the Closing will not be unreasonably small in relation to the
business in which Seller will engage after the Closing.  Upon and immediately
following the Closing Date, after giving effect to all of the transactions
contemplated by and in this Agreement (including the payment of the Purchase
Price), Seller will not be insolvent and will have sufficient capital to
continue in business and pay its debts as they become due.

4.11Revocation; Regulatory Change.  The Priority Review Voucher has not been
terminated, cancelled or revoked and Seller, to its knowledge, has not done or
omitted to do any act (including any act which could reasonably be expected to
result in the FDA invoking its policy respecting “Fraud, Untrue Statements of
Material Facts, Bribery and Illegal Gratuities” set forth in 56 Fed. Reg. 46191
(September 10, 1991)), which act or omission would reasonably be expected to
result in the termination, cancellation or revocation of the Priority Review
Voucher.  Since the date that the Priority Review Voucher was issued, to the
knowledge of the Seller, there has not occurred any Regulatory Change (which
definition, for the purpose of this Section 4.11, shall mean any change of the
kind described in clause (ii) of such definition and be measured from the date
of the issuance of the Priority Review Voucher).

4.12Marketed Product. Seller has initiated marketing in the United States of the
rare pediatric disease product for which the Priority Review Voucher was awarded
within the 365-day period beginning on the date of the FDA approval of such rare
pediatric disease product.  The rare pediatric disease product application for
which the Priority Review Voucher was awarded was not submitted by Seller to the
FDA prior to October 7, 2012.

4.13Document Disclosure. Attached as Schedule 4.13 is a true, correct and
complete list of all documents for which true, correct and complete copies have
been made available to Buyer as of the close of business on the last Business
Day immediately preceding the Closing Date, which list includes any and all
communications between Seller or its Affiliates, on the one hand, and the FDA,
on the other hand, with respect to the Purchased Assets.

4.14Intent to Use.  Neither Seller nor any of its Affiliates has filed or
submitted to the FDA a notification of intent to use the Priority Review
Voucher, as described in 21 USC 360ff(b)(4)(A).

4.15No Broker.  Except for Credit Suisse Securities (USA) LLC, the fees and
expenses of which shall be paid by Seller, there is no investment banker,
broker, finder or other intermediary which has been authorized to act on behalf
of Seller who might be entitled to any fee or commission in connection with the
transactions contemplated by this Agreement.

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ARTICLE V
REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer represents and warrants to Seller, as of the Effective Date and the
Closing Date, as follows:

5.1Organization, Standing and Power.  Buyer is a corporation duly organized and
validly existing under the laws of the State of Delaware.  Buyer has the
corporate power and authority to own, operate and lease its properties and to
carry on its business as presently conducted and is duly qualified or licensed
to do business and is in good standing in each jurisdiction where the character
of its properties owned or leased or the nature of its activities make such
qualification or licensing necessary, except where the failure to be so
qualified or licensed would not, individually or in the aggregate, reasonably be
expected to adversely affect Buyer’s ability to consummate the transactions
contemplated by this Agreement.  Buyer is not in violation of its certificate of
incorporation or bylaws, in each case as amended to date.

5.2Authority.  Buyer has the requisite corporate power and authority to enter
into and perform its obligations under this Agreement.  The execution, delivery
and performance of this Agreement, and the consummation of the Asset Purchase,
have been duly and validly approved and authorized by all necessary corporate
action on the part of Buyer, and this Agreement has been duly executed and
delivered by Buyer.   This Agreement, upon execution by the Parties, will
constitute a valid and binding obligation of Buyer enforceable against Buyer in
accordance with its terms, subject only to the effect, if any, of (a) applicable
bankruptcy and other similar laws affecting the rights of creditors generally
and (b) rules of law governing specific performance, injunctive relief and other
equitable remedies.

5.3Noncontravention.  The execution and delivery by Buyer of this Agreement does
not, and the consummation of the transactions contemplated hereby will not,
conflict with, or result in any violation of or default under (with or without
notice or lapse of time, or both), or give rise to a right of termination,
cancellation or acceleration of any obligation or loss of any benefit under, or
require any consent, approval or waiver from any Person pursuant to, (a) any
provision of the certificate of incorporation or bylaws of Buyer, in each case
as amended to date, (b) any Contract to which Buyer is a party or by which it is
bound which involves or affects in any way the Asset Purchase or (c) except as
may be required to comply with the HSR Act, any Legal Requirements applicable to
Buyer.

5.4No Consents.  Except for the letters referenced in Sections 3.2(d) and 3.2(e)
and the filing of a Premerger Notification and Report Form under the HSR Act, no
filing, authorization, consent, approval, permit, order, registration or
declaration, governmental or otherwise, is necessary to enable or authorize
Buyer to enter into, and to perform its obligations under, this Agreement.

ARTICLE VI
CONDITIONS TO CLOSING

6.1Conditions Precedent of Buyer and Seller. Each Party’s obligations to
consummate the transactions contemplated by this Agreement are subject to the
satisfaction or waiver, at or prior to the Closing Date, of each of the
following conditions precedent:

(a)HSR Act. The applicable waiting period under the HSR Act relating to the
transactions contemplated by this Agreement shall have expired or been
terminated.

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(b)No Injunctions or Restraints. No temporary restraining order, preliminary or
permanent injunction or other material legal restraint or prohibition issued or
promulgated by a Governmental Entity preventing the consummation of the
transactions contemplated by this Agreement shall be in effect, and there shall
not be any applicable Legal Requirement that makes consummation of the
transactions contemplated by this Agreement illegal.

(c)No Governmental Litigation. There shall not be any Proceeding commenced or
pending by a Governmental Entity seeking to prohibit, limit, delay, or otherwise
restrain the consummation of this Agreement and/or the transactions contemplated
hereby.

6.2Buyer’s Conditions Precedent. The obligations of Buyer to consummate the
transactions contemplated by this Agreement are subject to the satisfaction or
waiver, at or prior to the Closing Date, of each of the following conditions
precedent:

(a)Accuracy of Representations. Each of the representations and warranties made
by Seller in this Agreement (other than the representations and warranties made
by Seller in Sections 4.2, 4.5, 4.11, 4.12, 4.14, and 4.15) shall be true and
correct in all respects at and as of the Closing Date (or, if made as of a
specified period or date, as of such period or date), provided that any such
failure of such representations and warranties to be true and correct shall be
disregarded if it would not, individually or in the aggregate, reasonably be
expected to delay, restrict, limit, preclude or otherwise negatively impact in a
material manner the transfer and/or use of the Purchased Assets to or by Buyer.
Each of the representations and warranties made by Seller in Sections 4.2, 4.5,
4.11, 4.12 , 4.14, and 4.15 shall be true and correct in all respects at and as
of the Closing Date (or, in each case, if made as of a specified period or date,
as of such period or date).

(b)Performance of Covenants. All of the covenants and obligations that Seller is
required to comply with or to perform hereunder at or prior to the Closing Date
shall have been complied with and performed in all material respects.

(c)Closing Certificate. Seller shall have delivered to Buyer a certificate,
dated the Closing Date and duly executed by Seller, certifying that the
conditions set forth in Sections 6.2(a) and 6.2(b) have been satisfied.

(d)No Regulatory Change.  There shall not have occurred and remain in effect any
Regulatory Change

(e)Lender Consent.  The Consent and Second Amendment to Credit and Security
Agreement dated as of February 20, 2017 by and Among Seller and Midcap Financial
Trust, and the consent thereunder, shall not have been revoked and shall be in
full force and effect.

6.3Seller’s Conditions Precedent. The obligations of Seller to consummate the
transactions contemplated by this Agreement are subject to the satisfaction or
waiver, at or prior to the Closing Date, of each of the following conditions
precedent:

(a)Accuracy of Representations. Each of the representations and warranties made
by Buyer in this Agreement shall be true and correct in all material respects at
and as of the Closing Date (or, if made as of a specified period or date, as of
such period or date), except to the extent that such representations and
warranties are qualified by the term “material”, or words of similar import, in
which case such representations and warranties (as so written, including the
terms “material”, or words of similar import) shall be true and correct in all
respects at and as of the Closing Date (or, if made as of a specified period or
date, as of such period or date).

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(b)Performance of Covenants. All of the covenants and obligations that Buyer is
required to comply with or to perform hereunder at or prior to the Closing Date
shall have been complied with and performed in all material respects.

(c)Closing Certificate. Buyer shall have delivered to Seller a certificate,
dated the Closing Date and duly executed by Buyer, certifying that the
conditions set forth in Sections 6.3(a) and 6.3(b) have been satisfied.

ARTICLE VII
PRE-CLOSING COVENANTS AND AGREEMENTS

7.1The Parties shall use their commercially reasonable efforts to take, or cause
to be taken, all actions and to do, or cause to be done, all things necessary or
desirable under applicable Legal Requirements to consummate the transactions
contemplated by this Agreement.  Without limiting the foregoing, Seller and
Buyer shall file, or shall cause their ultimate parent entities as defined in
the HSR Act to file, as soon as practicable (but not later than ten Business
Days) after the Effective Date, any notifications required under the HSR Act,
and shall respond as promptly as practicable to all inquiries or requests
received from the Federal Trade Commission, the Antitrust Division of the
Department of Justice or any other Governmental Entity for additional
information or documentation.  In connection therewith, the Parties shall, or
shall cause their respective Affiliates to, (a) furnish to the other Party such
necessary information and reasonable assistance as the other Party may
reasonably request in connection with its preparation of any filing or
submission that is necessary under the HSR Act, and (b) keep the other Party
reasonably apprised of the status of any communications with, and any inquiries
or requests for additional information from the applicable Governmental Entity.

7.2Subject to applicable confidentiality restrictions or restrictions required
by applicable Legal Requirements, each Party will notify the other promptly upon
the receipt of (a) any comments or questions from any Governmental Entity in
connection with any filings made pursuant to Section 7.1 or the transactions
contemplated by this Agreement and (b) any request by any Governmental Entity
for information or documents relating to an investigation of the transactions
contemplated by this Agreement.  Without limiting the generality of the
foregoing, each Party shall provide to the other (or the other’s respective
advisors) upon request copies of all correspondence between such Party and any
Governmental Entity relating to the transactions contemplated by this
Agreement.  The Parties may, as they deem advisable and necessary, designate any
competitively sensitive materials provided to the other under this Section 7.2
as “outside counsel only.”  Such materials and the information contained therein
shall be given only to outside counsel of the recipient and will not be
disclosed by such outside counsel to employees, officers, or directors of the
recipient without the advance written consent of the Party providing such
materials.  In addition, to the extent reasonably practicable, all discussions,
telephone calls, and meetings with a Governmental Entity regarding the
transactions contemplated by this Agreement shall include representatives of
both Parties.  Subject to applicable Legal Requirements, the Parties will
consult and cooperate with each other in connection with any analyses,
appearances, presentations, memoranda, briefs, arguments, and proposals made or
submitted to any Governmental Entity regarding the transactions contemplated by
this Agreement by or on behalf of any Party.

7.3Notwithstanding the foregoing, nothing in this Agreement shall require, or be
construed to require, the Parties or any of their respective Affiliates to offer
or agree to (a) (i) sell, hold, hold separate, divest, license, discontinue or
limit, before or after the Closing Date, any assets, businesses, equity
holdings, intellectual property, or other interests or (ii) any conditions
relating to, or changes or restrictions in, the operations of any such assets,
businesses, equity holdings, intellectual property or interests (including but
not limited to any requirements to enter into new contracts or modify or
terminate existing contracts) or (b) any material modification or waiver of the
terms and conditions of this Agreement.

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7.4Until the earlier of the Closing or the termination of this Agreement, Seller
shall provide Buyer with prompt written notification of the occurrence of any
Regulatory Change (which definition, for purposes of this Section 7.4, shall
mean any change of the kind described in clause (ii) of such definition).

7.5Until the earlier of the Closing or the termination of this Agreement, Seller
shall use commercially reasonable efforts to maintain the Priority Review
Voucher in full force and effect and shall not (a) sell, assign, transfer or
convey the Priority Review Voucher to any Person other than Buyer or enter into
any Contract with respect thereto or (b) encumber or otherwise grant or allow to
exist any Encumbrance on the Priority Review Voucher (other than pursuant to
this Agreement).

ARTICLE VIII
INDEMNIFICATION

8.1Indemnification.

(a)Indemnification by Seller.  From and after the Closing, Seller will
indemnify, defend and hold Buyer and its Affiliates, and their respective
directors, officers, employees and agents harmless for, from and against any and
all Liabilities, losses, damages, claims, costs and expenses (including
reasonable attorneys’ fees) (collectively, “Damages”) arising out of any third
party claims (“Claims”) resulting from (i) any breach of Seller’s
representations, warranties, covenants or obligations under this Agreement or
any certificate delivered by Seller hereunder, (ii) Seller’s grossly negligent
and/or wrongful acts, omissions or misrepresentations, regardless of the form of
action, in connection with this Agreement, and/or (iii) any Excluded
Liabilities.

(b)Indemnification by Buyer.  From and after the Closing, Buyer will indemnify,
defend and hold Seller and its Affiliates, and their respective directors,
officers, employees and agents harmless for, from and against any and all
Damages arising out of any Claims resulting from (i) any breach of Buyer’s
representations, warranties, covenants or obligations under this Agreement or
any certificate delivered by Buyer hereunder, (ii) Buyer’s grossly negligent
and/or wrongful acts, omissions or misrepresentations, regardless of the form of
action, in connection with this Agreement, and/or (iii) Buyer’s, its
Affiliates’, or any subsequent transferee’s use or ownership of the Purchased
Assets.

8.2Indemnification Procedures.

(a)A Person entitled to indemnification pursuant to Section 8.1 will hereinafter
be referred to as an “Indemnitee.”  A Party obligated to indemnify an Indemnitee
hereunder will hereinafter be referred to as an “Indemnitor.” Indemnitee shall
inform Indemnitor of any Claim as soon as reasonably practicable after the Claim
arises, it being understood and agreed that the failure to give such notice will
not relieve the Indemnitor of its indemnification obligation under this
Agreement except and only to the extent that such Indemnitor is actually and
materially prejudiced as a result of such failure to give notice.

(b)If the Indemnitor has acknowledged in writing to the Indemnitee the
Indemnitor’s responsibility for defending such Claim and such Claim is not a
class action or criminal matter, the Indemnitor shall have the right to defend,
at its sole cost and expense, such Claim by all appropriate proceedings, which
proceedings shall be prosecuted diligently by the Indemnitor to a final
conclusion or settled at the discretion of the Indemnitor; provided, however,
that the Indemnitor may not enter into any compromise or settlement unless (i)
such compromise or settlement includes as an unconditional term thereof, the
giving by each claimant or plaintiff to the Indemnitee of a release from all
liability in respect of such Claim; and (ii) the Indemnitee consents to such
compromise or settlement, which consent shall not be unreasonably withheld or
delayed unless such compromise or settlement

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involves (A) any admission of legal wrongdoing by the Indemnitee, (B) any
payment by the Indemnitee that is not indemnified hereunder or (C) the
imposition of any equitable relief against the Indemnitee, in which case ((A) –
(C)) the Indemnitee may withhold its consent in its sole discretion.  If a good
faith and diligent defense is not being or ceases to be materially conducted by
the Indemnitor, the Indemnitee shall have the right, at the expense of the
Indemnitor, upon at least ten (10) Business Days’ prior written notice to the
Indemnitor of its intent to do so, to undertake the defense of such Claim for
the account of the Indemnitor (with counsel reasonably selected by the
Indemnitee and approved by the Indemnitor, such approval not to be unreasonably
withheld or delayed).  If the Indemnitee is defending such Claim, the Indemnitee
shall keep the Indemnitor apprised of all material developments with respect to
such Claim and promptly provide the Indemnitor with copies of all correspondence
and documents exchanged by the Indemnitee and the opposing party(ies) to such
litigation.  If the Indemnitor has elected to defend such Claim or if the
Indemnitor has otherwise acknowledged in writing its responsibility for
indemnifying a Claim, the Indemnitee may not compromise or settle such
litigation without the prior written consent of the Indemnitor, such consent not
to be unreasonably withheld or delayed.

(c)The Indemnitee may participate in, but not control, any defense or settlement
of any Claim controlled by the Indemnitor pursuant to this Section 8.2 and shall
bear its own costs and expenses with respect to such participation; provided,
however, that the Indemnitor shall bear such costs and expenses if counsel for
the Indemnitor shall have reasonably determined that such counsel may not
properly represent both the Indemnitor and the Indemnitee.

ARTICLE IX
TERMINATION

9.1Termination Prior to Closing. Notwithstanding any contrary provisions of this
Agreement, the respective obligations of the Parties hereto to consummate the
transactions contemplated by this Agreement may be terminated and abandoned at
any time before the Closing only as follows:

(a)Upon the mutual written consent of Buyer and Seller; or

(b)By either Party, by written notice to the other Party if the Closing has not
occurred on or before 11:59 p.m., Cambridge Massachusetts time, on the date that
is [three (3) months] from the Effective Date; provided, however, that the right
to terminate this Agreement under this Section 9.1(b) shall not be available to
any Party whose material breach of any provision set forth in this Agreement has
resulted in the failure of the Closing to occur on or before such date.

9.2Effect of Termination. In the event of the termination of this Agreement as
provided in Section 9.1, written notice thereof shall forthwith be given to the
other Party hereto specifying the provision hereof pursuant to which such
termination is made, and this Agreement shall forthwith become null and void
(except for the provisions of this Section 9.2, Section 10.4, ARTICLE I and
ARTICLE XI, which shall survive any such termination) and there shall be no
liability on the part of Buyer or Seller except for damages resulting from any
breach of this Agreement prior to termination of this Agreement by Buyer or
Seller.

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ARTICLE X
ADDITIONAL COVENANTS

10.1Further Assurances.

(a)The Parties shall cooperate reasonably with each other in connection with any
steps required to be taken as part of their respective obligations under this
Agreement, including without limitation any notifications or filings required to
be made to the FDA in connection with the transfer of the Purchased Assets, and
shall (i) furnish upon request to each other such further information, (ii)
execute and deliver to each other such other documents, and (iii) do such other
acts and things, all as the other Party may reasonably request for the purpose
of carrying out the intent of this Agreement and the transactions contemplated
by this Agreement, including the use by Buyer, its Affiliates or their
respective successors and assigns of the Priority Review Voucher in accordance
with its terms and applicable Legal Requirements.

(b)Without limiting the foregoing, Buyer and Seller agree to cooperate and
assist each other with respect to all filings or notifications to any
Governmental Entity related to the transfer and assignment of the Purchased
Assets.

10.2Compliance with Legal Requirements. Seller shall at all times comply in all
material respects with all Legal Requirements applicable to the Purchased
Assets, including any and all Legal Requirements applicable to the use or
transfer of the Priority Review Voucher.  Seller shall forward to Buyer any
communications or notices it or its Affiliates receive from any Governmental
Entity in respect of the Purchased Assets.  

10.3Marketing.  Seller will continuously market in the United States the rare
pediatric disease product for which the Priority Review Voucher was awarded for
the 365-day period beginning on the date of the FDA approval of such rare
pediatric disease product to the extent required under applicable Legal
Requirements or otherwise by any applicable Governmental Entity for the
continued use of, or right to transfer, the Priority Review Voucher in the
United States.

10.4Nondisclosure.

(a)Subject to disclosures permitted or contemplated by Section 10.5, with
respect to Confidential Information received, the Parties will (i) keep the
Confidential Information confidential, (ii) not use any Confidential Information
for any reason other than to carry out the intent and purpose of this Agreement,
and (iii) not disclose any Confidential Information to any Person, except in
each case as otherwise expressly permitted by this Agreement or with the prior
written consent of the disclosing Party.

(b)Each Party may disclose Confidential Information only to its Representatives
on a need-to-know basis.

(c)Each Party will (i) enforce the terms of this Section 10.4 as to its
Representatives, (ii) take such action to the extent necessary to cause its
Representatives to comply with the terms and conditions of this Section 10.4,
and (iii) be responsible and liable for any breach of this Section 10.4 by it or
its Representatives.

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(d)If a Party becomes compelled by a court or is requested by a Governmental
Entity to make any disclosure that is prohibited or otherwise constrained by
this Section 10.4, such Party shall provide the disclosing Party with prompt
notice of such compulsion or request so that it may seek an appropriate
protective order or other appropriate remedy or waive compliance with the
provisions of this Section 10.4. In the absence of a protective order or other
remedy, the Party subject to the requirement to disclose may disclose that
portion (and only that portion) of the Confidential Information that, based upon
advice of its counsel, it is legally compelled to disclose or that has been
requested by such Governmental Entity; provided, however, that such Party shall
use reasonable efforts to obtain reliable assurance that confidential treatment
will be accorded by any Person to whom any Confidential Information is so
disclosed.

10.5Disclosures Concerning this Agreement.  The Parties have mutually agreed
upon the contents of a press release with respect to the execution of this
Agreement, which is attached as Exhibit D hereto and shall be issued by Seller
on or on the next Business Day following the Effective Date.  Buyer and Seller
agree not to (and to ensure that their respective Affiliates do not) issue any
other press releases or public announcements concerning this Agreement without
the prior written consent of the other Party (which shall not be unreasonably
withheld or delayed), except as required by a Governmental Entity or applicable
Legal Requirement (including the rules and regulations of any stock exchange or
trading market on which a Party’s (or its parent entity’s) securities are
traded); provided that the Party intending to disclose such information shall
use reasonable efforts to provide the other Party with advance notice of such
required disclosure, and an opportunity to review and comment on such proposed
disclosure (which comments shall be considered in good faith by the disclosing
Party).  Notwithstanding the foregoing, without prior submission to or approval
of the other Party, either Party may issue press releases or public
announcements which incorporate information concerning this Agreement which
information was included in a press release or public disclosure which was
previously disclosed under the terms of this Agreement or which contains only
non-material factual information regarding this Agreement.  Each Party
acknowledges that the other Party, or the other Party’s parent entity, as a
publicly traded company is legally obligated to make timely disclosures of
material events relating to its business.  The Parties acknowledge that either
or both Parties may be obligated to file a copy of this Agreement with the
United States Securities and Exchange Commission; provided that if a Party is
obligated to so file a copy of this Agreement, such Party shall prepare a
proposed redacted version thereof and request confidential treatment thereof,
and the other Party may promptly provide its comments thereon, which comments
shall be considered in good faith by the Party required to so file a copy of
this Agreement.

ARTICLE XI
GENERAL PROVISIONS

11.1Survival.  Except as expressly set forth herein, the representations and
warranties contained in this Agreement, and liability for the breach thereof,
shall survive the Closing Date and shall remain in full force and effect for a
period of three (3) years following the Closing Date; provided, however, that
the representations and warranties contained in Sections 4.2, 4.5, 4.11, 4.12 ,
4.14, and 4.15 hereof, and all covenants and obligations contained herein,
shall, in each case, survive the Closing Date and remain in full force and
effect until the expiration of the applicable statute of limitations.

11.2Transfer Taxes and Fees. Any and all sales, excise, use, value-added and
similar taxes, fees or duties assessed or incurred by reason of the sale by
Seller and the purchase by Buyer of the Purchased Assets hereunder shall be
shared equally between the Seller and Buyer, regardless of which Party such
taxes, fees or duties are assessed against.

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11.3Notices.  Any notice or other communication required or permitted to be
delivered to any Party shall be in writing and shall be deemed properly
delivered, given and received: (a) when delivered by hand; (b) upon such Party’s
receipt after being sent by registered mail, by courier or express delivery
service; or (c) upon confirmation of receipt during normal business hours on a
Business Day or, if received after normal business hours, on the next Business
Day, after being sent by facsimile, in any case to the address or facsimile
number set forth beneath the name of such Party below (or to such other address
as such Party shall have specified in a written notice given to the other Party
in accordance with this Section 11.3):

(i) if to Buyer, to:

 

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA  94404

United States of America

Attention:  General Counsel

Facsimile: +1 650 522 5771

 

with a copy (which shall not constitute notice) to:

 

Covington & Burling LLP

One Front Street

San Francisco, California  94111

United States of America

Attention:  Amy Toro and Jonas Marson

Facsimile: +1 415 591 6091

(ii) if to Seller, to:

Sarepta Therapeutics, Inc.

215 First Street, Suite 415

Cambridge, MA 02127

Attention:  General Counsel

 

with a copy (which shall not constitute notice) to:

 

Cooley LLP

3175 Hanover St.

Palo Alto, CA 94304

Attention:  Glen Sato

Facsimile: +1 650 849 7400

 

11.4Construction.

(a)The Parties agree that any rule of construction to the effect that
ambiguities are to be resolved against the drafting Party shall not be applied
in the construction or interpretation of this Agreement.  

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(b)As used in this Agreement, the words “include” and “including,” and
variations thereof, shall not be deemed to be terms of limitation, but rather
shall be deemed to be followed by the words “without limitation.”

(c)Except as otherwise indicated, all references in this Agreement to “Articles”
and “Sections” are intended to refer to Articles and Sections of this
Agreement.  

11.5Counterparts.  This Agreement may be executed in two or more counterparts,
all of which shall be considered one and the same instrument, and shall become
effective when one or more counterparts have been signed by each of the Parties
hereto and delivered to the other Party hereto, it being understood that all
Parties hereto need not sign the same counterpart.  The exchange of a fully
executed Agreement (in counterparts or otherwise) by electronic transmission or
facsimile shall be sufficient to bind the Parties hereto to the terms and
conditions of this Agreement.

11.6Entire Agreement.  This Agreement, including all exhibits and schedules
attached hereto, sets forth the entire understanding of the Parties relating to
the subject matter hereof and supersedes all prior agreements and understandings
among or between the Parties relating to the subject matter hereof.

11.7Assignment.  No Party will have the right to assign this Agreement, in whole
or in part, by operation of law or otherwise, without the other Party’s express
prior written consent.  Any attempt to assign this Agreement without such
consent, will be null and void.  Notwithstanding the foregoing, any Party may
assign this Agreement, in whole or in part, without the consent of the other
Party: (a) to a Third Party that succeeds to all or substantially all of its
assets or business related to this Agreement (whether by sale, merger, operation
of law or otherwise); or (b) to an Affiliate of such Party.  Notwithstanding the
foregoing, Buyer may assign this Agreement, in whole or in part, without
Seller’s consent, to any purchaser, transferee, or assignee of any of the
Purchased Assets.  For the avoidance of doubt, no assignment made pursuant to
this Section 11.7 shall relieve the assigning Party of any of its obligations
under this Agreement.  Subject to the foregoing, this Agreement will bind and
inure to the benefit of each Party’s successors and permitted assigns.

11.8Severability.  If any provision of this Agreement, or the application
thereof, becomes or is declared by a court of competent jurisdiction to be
illegal, void or unenforceable, the remainder of this Agreement shall continue
in full force and effect and shall be interpreted so as reasonably to effect the
intent of the Parties hereto.  The Parties hereto shall use commercially
reasonable efforts to replace such void or unenforceable provision of this
Agreement with a valid and enforceable provision that shall achieve, to the
extent possible, the economic, business and other purposes of such void or
unenforceable provision.

11.9Remedies Cumulative.  Except as otherwise provided herein, any and all
remedies herein expressly conferred upon a Party hereto shall be deemed
cumulative with and not exclusive of any other remedy conferred hereby or by law
or equity upon such Party, and the exercise by a Party hereto of any one remedy
shall not preclude the exercise of any other remedy and nothing in this
Agreement shall be deemed a waiver by any Party of any right to specific
performance or injunctive relief.

11.10Governing Law.  This Agreement shall be governed by, and construed in
accordance with, the laws of the State of New York, regardless of the laws that
might otherwise govern under applicable principles of conflicts of law.  The
Parties irrevocably and unconditionally submit to the exclusive jurisdiction of
the United States District Court for the Southern District of New York (or if
such court does not have subject matter jurisdiction, State Court of the State
of New York located in New York County) solely and specifically for the purposes
of any action or proceeding arising out of or in connection with this Agreement.

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11.11Amendment; Extension; Waiver.  Subject to the provisions of applicable
Legal Requirements, the Parties hereto may amend this Agreement at any time
pursuant to an instrument in writing signed on behalf of each of the Parties
hereto.  At any time, any Party hereto may, to the extent legally allowed,
(a) extend the time for the performance of any of the obligations or other acts
of the other Party hereto, (b) waive any inaccuracies in the representations and
warranties made to such Party contained herein or (c) waive compliance with any
of the agreements or conditions for the benefit of such Party contained
herein.  Any agreement on the part of a Party hereto to any such extension or
waiver shall be valid only if set forth in an instrument in writing signed on
behalf of such Party.  Without limiting the generality or effect of the
preceding sentence, no delay in exercising any right under this Agreement shall
constitute a waiver of such right, and no waiver of any breach or default shall
be deemed a waiver of any other breach or default of the same or any other
provision in this Agreement.

11.12Representation By Counsel; Interpretation.  Seller and Buyer each
acknowledge that it has been represented by its own legal counsel in connection
with this Agreement and the transactions contemplated by this
Agreement.  Accordingly, any rule of law, or any legal decision that would
require interpretation of any claimed ambiguities in this Agreement against the
Party that drafted it, has no application and is expressly waived.

 

[Signature Page Follows]

 

 

 

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IN WITNESS WHEREOF, each of Buyer and Seller has caused this Asset Purchase
Agreement to be executed and delivered by their respective officers thereunto
duly authorized, all as of the date first written above.

 

GILEAD SCIENCES, INC.

 

 

 

By:

 

/s/ John F. Milligan

Name:

 

John F. Milligan

Title:

 

President and CEO

 

SAREPTA THERAPEUTICS INC.

 

 

 

By:

 

/s/ Edward M. Kaye, M.D.

Name:

 

Edward M. Kaye, M.D.

Title:

 

President and CEO

 

 

 

[Signature Page to Asset Purchase Agreement]

 

 

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Exhibit A

FORM OF BILL OF SALE

This Bill of Sale (this “Bill of Sale”) is entered into as of [          ], by
and between  SAREPTA THERAPEUTICS INC., a corporation organized under the laws
of Delaware (“Seller”), and GILEAD SCIENCIES, INC., a corporation organized
under the laws of the State of Delaware (“Buyer”).

Upon the terms and subject to the conditions of the Asset Purchase Agreement,
dated as of February 20, 2017 (the “Asset Purchase Agreement”), by and between
Buyer and Seller, Seller has agreed to sell, and Buyer has agreed to purchase,
all right, title and interest in, to and under the Purchased Assets, including
the Priority Review Voucher, in each case free and clear of all Encumbrances.

For good and valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, Buyer and Seller, intending to be legally bound, hereby
agree as follows:

Defined Terms; Interpretation.  Except as otherwise set forth herein,
capitalized terms used in this Bill of Sale shall have the meanings assigned to
them in the Asset Purchase Agreement.  This Bill of Sale shall be interpreted in
accordance with the rules of construction set forth in Section 11.4 of the Asset
Purchase Agreement.

Transfer of Purchased Assets.  Pursuant to the terms and subject to the
conditions of the Asset Purchase Agreement, Seller hereby sells, assigns,
transfers, and conveys to Buyer and its successors and its assigns, and Buyer
hereby does purchase from Seller, all of Seller’s right, title and interest in,
to and under the Purchased Assets (including the Priority Review Voucher), in
each case free and clear of all Encumbrances.

Effective Time.  This Bill of Sale shall be effective as of the Closing.

Binding Effect; Amendments.  This Bill of Sale shall be binding upon, inure to
the benefit of, and be enforceable by, the parties hereto and their respective
legal representatives, successors and permitted assigns.  Neither this Bill of
Sale, nor any term or provision hereof, may be amended, modified, superseded or
cancelled except by an instrument in writing signed by each party hereto.

Governing Law.  This Bill of Sale and any disputes arising under or related
hereto shall be governed by the rules set forth in Section 11.10 of the Asset
Purchase Agreement.

Counterparts.  This Bill of Sale may be executed in one or more counterparts,
each of which shall be deemed an original but all of which together will
constitute one and the same instrument.

 

[Signature Page Follows]

 

 

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IN WITNESS WHEREOF, the parties hereto have caused this Bill of Sale to be
executed and delivered as of the date first written above.

GILEAD SCIENCES, INC.

 

Sarepta Therapeutics Inc.

 

 

 

 

 

 

 

By:

 

 

 

By:

 

 

Name:

 

 

 

Name:

 

 

Title:

 

 

 

Title:

 

 

 

 

 

[Signature Page to Bill of Sale]

 

 

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Exhibit B

Seller’s Transfer Acknowledgment Letter

[Sarepta’s Letterhead]

[Date]

Gilead Sciences, Inc.

[Buyer Contact]

[Buyer Address]

RE: NDA 206488 Exondys 51 (eteplirsen) Injection, 50mg per mL – Transfer of Rare
Pediatric Disease Priority Review Voucher PRV NDA 206488 (the “Voucher”)

Dear [Buyer Contact]:

Reference is made to the subject NDA and all related correspondence.

Please be advised that as of [Date], Gilead Sciences, Inc. (“Buyer”) has legally
accepted complete ownership of the Voucher from Sarepta Therapeutics Inc.
(“Sarepta”).  Sarepta hereby authorizes transfer of ownership of the Voucher to
Buyer.

Sarepta has provided Buyer with an unredacted copy of the Exondys 51 (NDA
206488) approval letter from the Department of Health and Human Services to
Sarepta (Reference ID 3987286), which includes the Voucher (the “Approval
Letter”).  Buyer agrees to use the Voucher in accordance with the terms of the
Approval Letter.  

Please do not hesitate to contact me should you have any questions or comments.

Sincerely,

[Sarepta Contact]

 

 

 

 

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Exhibit C

Buyer’s Transfer Acknowledgment Letter

[Gilead Sciences, Inc. Letterhead]

[Date]

Sarepta Therapeutics Inc.

[Seller Contact]

[Seller Address]

RE: NDA 206488 Exondys 51 (eteplirsen) Injection, 50mg per mL – Transfer of Rare
Pediatric Disease Priority Review Voucher PRV NDA 206488 (the “Voucher”)

Dear [Seller Contact]:

Reference is made to the subject NDA and related correspondence regarding PRV
NDA 206488.

Please be advised that as of [Date], Gilead Sciences, Inc. (“Buyer”) has legally
accepted complete ownership of the Voucher from Sarepta Therapeutics Inc.
(“Sarepta”).

Sarepta has provided Buyer with an unredacted copy of the Exondys 51 (NDA
206488) approval letter from the Department of Health and Human Services to
Sarepta (Reference ID 3987286), which includes the Voucher (the “Approval
Letter”).  Buyer will advise the U.S. Food and Drug Administration (“FDA”) of
the legal transfer of the Voucher from Sarepta to Buyer by providing a copy of
this letter to the FDA, and agrees to use the Voucher in accordance with the
terms of the Approval Letter.

The regulatory contact information for the Voucher is as follows:

[[Buyer] Contact]

Please do not hesitate to contact me should you have any questions or comments.

Sincerely,

[[Buyer] Contact]

 

 

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Exhibit D

Press Release

Sarepta Therapeutics Agrees to Sale of Priority Review Voucher for $125M

-- Sale of PRV Provides a Significant Infusion of Non-Dilutive Capital --

CAMBRIDGE, Mass.--(BUSINESS WIRE)—February X, 2017--Sarepta Therapeutics,
Inc. (NASDAQ:SRPT), a commercial-stage developer of innovative RNA-targeted
therapeutics, today announced it has entered into an agreement to sell its Rare
Pediatric Disease Priority Review Voucher (PRV).  Sarepta received the PRV when
EXONDYS 51TM was approved by the U.S. Food and Drug Administration (FDA) for the
treatment of patients with Duchenne muscular dystrophy amenable to exon 51
skipping.

The voucher was awarded by the FDA under a provision that encourages development
of new drugs and biologics for the prevention and treatment of rare pediatric
diseases. With the passage of the 21st Century Cures Act, this PRV program has
been extended through September 30, 2020.

As part of the agreement, Sarepta will receive an upfront payment of $125M upon
the closing of the transaction, which is subject to customary closing conditions
and is expected to occur following expiration of the applicable U.S. antitrust
clearance requirements. Credit Suisse served as Sarepta’s advisor on this
transaction and conducted an extensive sales process, which included outreach to
multiple pharmaceutical and biotech companies.  

“Our mission at Sarepta Therapeutics is to treat more boys with Duchenne
muscular dystrophy,” said Edward Kaye, Sarepta’s chief executive officer. “The
sale of the PRV provides an important source of non-dilutive capital to support
the rapid advancement of our follow on exon skipping candidates and next
generation RNA targeted antisense platform.”

About Sarepta Therapeutics

Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on
the discovery and development of unique RNA-targeted therapeutics for the
treatment of rare neuromuscular diseases. The Company is primarily focused on
rapidly advancing the development of its potentially disease-modifying DMD drug
candidates. For more information, please visit us at www.sarepta.com.

About the Rare Pediatric Disease Priority Review Voucher Program

The program is intended to encourage development of new drug and biological
products for prevention and treatment of certain rare pediatric diseases. A PRV
may be issued to the sponsor of a rare pediatric disease product application and
would entitle the holder to priority review of a single New Drug Application or
Biologics License Application, which reduces the target review time and could
lead to an expedited approval. The sponsor receives the PRV upon approval of the
rare pediatric disease product application and it can be sold without
limitation, subject to applicable FDA requirements for filing and use.

 

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Forward-Looking Statements

This press release contains forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995 (the “Act”) and the protection
of the Act’s Safe Harbor for forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to Sarepta’s
commercialization and development activities, including the potential for
success and timing for the progression of Sarepta’s drug candidates; current
regulatory requirements for approval of the purchase transaction and the
viability of the priority review voucher sold; and Sarepta’s capital needs. Such
statements are based on management’s current expectations, but actual results
may differ materially due to various risks and uncertainties, including, whether
regulatory requirements may change that affect the timing for payment and risk
of payment under the royalty agreement with the pharmaceutical company
purchaser. For further information regarding these and other risks related to
Sarepta’s business, investors should consult Sarepta’s most recent Quarterly
Report on Form 10-Q filing with the Securities and Exchange Commission.
Forward-looking statements are not guarantees of future performance, and
Sarepta’s actual results of operations, financial condition and liquidity, and
the development of the industry in which it operates, may differ materially from
the forward-looking statements contained in this press release. Sarepta assumes
no obligation to update its forward-looking statements whether as a result of
new information, future events or otherwise, after the date of this press
release.

Internet Posting of Information

We routinely post information that may be important to investors in the 'For
Investors' section of our website at www.sarepta.com. We encourage investors and
potential investors to consult our website regularly for important information
about us.  

Source: Sarepta Therapeutics, Inc.

Media and Investors:

Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com

Or

W2O Group

Brian Reid, 212-257-6725

breid@w2ogroup.com

 

 

 

 

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Schedule 4.13

 

Accelerated Approval Letter from Department of Health and Human Services of the
FDA to Seller dated September 19, 2016

 

Consent and Second Amendment to Credit and Security Agreement dated as of
February 20, 2017 by and Among Seller and Midcap Financial Trust