UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 15, 2019
Biohaven Pharmaceutical Holding Company Ltd.
(Exact name of registrant as specified in its charter)
British Virgin Islands |
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001-38080 |
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Not applicable |
(State or other jurisdiction of
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(Commission File Number) |
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(IRS Employer
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c/o Biohaven Pharmaceuticals, Inc.
215 Church Street
New Haven, Connecticut 06510
(Address of principal executive offices, including zip code)
(203) 404-0410
(Registrants telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 1.01. Entry into a Material Definitive Agreement.
PRV Purchase Agreement
On March 15, 2019, pursuant to a PRV Transfer Agreement (the PRV Agreement ) entered into on the same date by Biohaven Pharmaceutical Holding Company Ltd. (the Company ) and GW Research, Ltd ( GW ), the Company agreed to purchase a Rare Pediatric Disease Priority Review Voucher (the PRV ) from GW for $105 million in cash. The closing of the transaction is subject to customary closing conditions, including antitrust review.
The foregoing description of the PRV Agreement is not complete and is qualified in its entirety by reference to the full text of the PRV Agreement, a copy of which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.
Series A Preferred Share Purchase Agreement
On March 18, 2019, in connection with the PRV Agreement, the Company entered into a Series A Preferred Share Purchase Agreement (the Preferred Purchase Agreement ) with RPI Finance Trust, a Delaware statutory trust ( RPI ), pursuant to which the Company, in a private placement, agreed to issue and sell to RPI 2,495 Series A Preferred Shares, of no par value, of the Company, at a price of $50,100.00 per share for gross proceeds to the Company of approximately $125 million before deducting fees and expenses (the Initial Closing ).
Additionally, commencing upon the date on which the U.S. Food and Drug Administration, or any successor agency thereto (the FDA ) has accepted both of (x) the New Drug Application ( NDA ) with respect to the oral dissolving tablet ( ODT ) formulation of rimegepant and (y) the NDA with respect to the tablet formulation of rimegepant (the later of such dates, the Second NDA Acceptance Date ), one of which NDAs shall have been accepted under the FDAs Priority Review Designation pathway in accordance with Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act, 21 USC 301, et seq. as amended, and including any rules, regulations and requirements promulgated thereunder, and ending upon the first anniversary of the Second NDA Acceptance Date (the Outside Date ), the Company may issue and sell to RPI, and RPI will purchase from the Company, in up to three additional closings, up to an aggregate of $75 million of additional Series A Preferred Shares upon the same terms as the Initial Closing (each, a Subsequent Closing and, collectively with the Initial Closing, the Financing ).
Redemption
If a Change of Control (as defined in the Amended and Restated Memorandum & Articles of Association to be adopted in connection with the Financing) is announced within six months following the Initial Closing, the Company shall have the option to redeem the Series A Preferred Shares for one point five times (1.5x) the original purchase price of the Series A Preferred Shares upon the closing of the Change of Control. If the Company does not elect to redeem the Series A Preferred Shares for 1.5x at the closing of such Change of Control, then the Company would be required to redeem the Series A Preferred Shares for two times (2x) the original purchase price, payable in equal quarterly installments following closing of the Change of Control through December 31, 2024.
If a Change of Control is announced more than six months following the Initial Closing and the Series A Preferred Shares have not previously been redeemed, the Company must redeem the Series A Preferred Shares for two times (2x) the original purchase price of the Series A Preferred Shares payable in a lump sum or in equal quarterly installments following the closing of the Change of Control through December 31, 2024.
If an NDA for rimegepant is not approved by December 31, 2021, RPI has the option at any time thereafter to require the Company to redeem the Series A Preferred Shares for one point two times (1.2x) the original purchase price of the Series A Preferred Shares.
If no Change of Control has been announced, the Series A Preferred Shares have not previously been redeemed and (i) rimegepant is approved on or before December 31, 2024, following approval and starting one-year after approval, the Company must redeem the Series A Preferred Shares for two times (2x) the original purchase price, payable in a lump sum or in equal quarterly installments through December 31, 2024 (provided that if rimegepant is approved in 2024, the entire redemption amount must be paid by December 31, 2024) or (ii) rimegepant is not approved by December 31, 2024, the Company must redeem the Series A Preferred Shares for two times (2x) the original purchase price on December 31, 2024.
The Company may redeem the Series A Preferred Shares at its option at any time for two times (2x) the original
purchase price, which redemption price may be paid in a lump sum or in equal quarterly installments through December 31, 2024.
Liquidation and Voting
The Series A Preferred Shares have a liquidation preference equal to two times (2x) the original purchase price therefor in the event of a voluntarily or involuntary liquidation, dissolution or winding up of the Company. The Series A Preferred Shares are entitled to vote with the Common Shares on matters submitted to a vote of the holders of Common Shares on the basis of 1,000 votes per share, which is the equivalent number of votes that could have been purchased in Common Shares based on the closing price of the Companys Common Shares on March 15, 2019.
Protective Provisions
The Series A Preferred Shares have customary protective provisions which provide that, without the approval of holders of a majority of the Series A Preferred Shares, the Company may not adversely affect the rights of the Series A Preferred Shares or create, authorize or issue any class or series of equity securities of the Company senior to, or pari passu with, the Series A Preferred Shares. However, the Company is permitted to issue equity securities ranking junior to the Series A Preferred Shares, including Common Shares, as well as convertible and/or non-convertible debt.
Other
In the event the Company defaults on any obligation to redeem Series A Preferred Shares when required, the redemption amount shall accrue interest at the rate of eighteen percent (18%) per annum. If any such default continues for at least one year, the holders of such shares shall be entitled to convert, subject to certain limitations, such Series A Preferred Shares into Common Shares, with no waiver of their redemption rights. The Series A Preferred Shares are otherwise not convertible into Common Shares in any circumstances.
The Preferred Purchase Agreement contains various representations and warranties, covenants, indemnification obligations and other provisions customary for transactions of this nature. The Initial Closing is, and any Subsequent Closing will be, subject to customary closing conditions.
The Series A Preferred Shares were offered and will be issued and sold in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended (the Securities Act ), set forth under Section 4(a)(2) of the Securities Act relating to sales by an issuer not involving any public offering and in reliance on similar exemptions under applicable state laws. RPI represented that it is an accredited investor and that it is acquiring the Series A Preferred Shares for investment purposes only and not with a view to any resale, distribution or other disposition of such securities in violation of the United States federal securities laws. Neither this Current Report on Form 8-K, nor the press release furnished herewith as Exhibit 99.1 is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.
The Company expects to use the proceeds from the Financing for the purchase of the PRV and working capital and general corporate purposes, including the continued development and commercialization of its lead product candidate, rimegepant.
The foregoing description of the Series A Preferred Shares does not purport to be complete and is qualified in its entirety by reference to the complete text of the Amended and Restated Memorandum & Articles of Association which will be adopted prior to the Initial Closing and will be filed as an exhibit to a Current Report on Form 8-K to be filed in connection therewith.
The foregoing description of the Preferred Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Preferred Purchase Agreement, which will be filed as an exhibit to the Companys next quarterly report on Form 10-Q.
Forward-Looking Statements
This Current Report on Form 8-K includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Companys management. All statements, other than statements of historical facts, included in this Current Report regarding the Companys business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected
timing, commencement and outcomes of the Companys planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the expected issuance of preferred stock to RPI, the potential commercialization of the Companys product candidates and the potential for the Companys product candidates to be first in class or best in class therapies. The use of certain words, including believe, continue, may, on track, expects and will and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the Risk Factors section of the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Item 3.02. Unregistered Sale of Equity Securities.
The information set forth under Item 1.01 of this Current Report on Form 8-K is incorporated by reference in response to this Item 3.02.
Item 3.03. Material Modification to Rights of Security Holders
The information set forth under Item 1.01 of this Current Report on Form 8-K is incorporated by reference in response to this Item 3.03.
Item 7.01. Regulation FD Disclosure.
On March 18, 2019, the Company issued a press release announcing the entry into the PRV Agreement, the Financing and the matters described in Item 1.01. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act ) or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the Securities Act ). The information in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
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Number |
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Exhibit Description |
2.1* |
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99.1 |
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* Pursuant to Item 601(b)(2) of Regulation S-K promulgated by the SEC, certain exhibits and schedules to this agreement have been omitted. The Company hereby agrees to furnish supplementally to the SEC, upon its request, any or all of such omitted exhibits or schedules.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Biohaven Pharmaceutical Holding Company Ltd. |
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By: |
/s/ Vlad Coric, M.D. |
Date: March 18, 2019 |
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Vlad Coric, M.D. |
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Chief Executive Officer |
PRV TRANSFER AGREEMENT
BY AND BETWEEN
BIOHAVEN PHARMACEUTICAL HOLDING LTD
AND
GW RESEARCH, LTD.
March 15, 2019
PRV TRANSFER AGREEMENT
This PRV TRANSFER AGREEMENT (this Agreement ) is made and entered into as of March 15, 2019 (the Effective Date ), by and between Biohaven Pharmaceutical Holding Ltd, including its Affiliates (collectively Buyer ) and GW Research, Ltd., including its Affiliates (collectively, 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 (a) desire that Buyer purchase from Seller, and Seller sell, transfer and assign to Buyer, the Transferred Rights (as defined below), all on the terms set forth herein (such transaction, the PRV Transfer ) and (b), 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 PRV Transfer 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
1.1 Certain Definitions . As used in this Agreement, the following capitalized 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%) 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) Alternative Transaction means, other than the transactions contemplated by this Agreement, any sale, assignment, transfer or encumbrance, whether by option, agreement, understanding or other arrangement, of any right, title, or interest in and to the Transferred Rights.
(c) 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.
(d) Confidential Information means (i) any and all confidential and proprietary information, including, 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, including the negotiations between the Parties. Confidential Information 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 recipients contemporaneous written records. Notwithstanding anything herein to the contrary, all Confidential Information included within the Transferred Rights shall constitute Confidential Information of the Buyer from and after the Closing Date.
(e) 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).
(f) Damages means all losses, Liabilities, damages, settlements, claims, causes of action, Orders, awards, suits, taxes, fines, penalties, costs or expenses (including reasonable attorneys and experts fees and expenses).
(g) Encumbrance means any lien, pledge, charge, mortgage, easement, encroachment, imperfection of title, title exception, title defect, right of possession, right of negotiation or refusal, lease, security interest, encumbrance, adverse claim, interference or restriction on use or transfer.
(h) Excluded Liabilities has the meaning set forth in Section 2.1(b) .
(i) FDA means the United States Food and Drug Administration.
(j) FDA Notification Package means, collectively, executed versions of the joint FDA notification cover letter, Seller transfer acknowledgement letter and Buyer transfer acknowledgment letter in the forms set forth in Exhibits C-1 , C-2 , and C-3 , respectively, and, with respect to such joint FDA notification cover letter as set forth in Exhibit C-1 , any other documentation referred to therein as being attached thereto, in each case, with respect to the purchase and sale of the Priority Review Voucher pursuant to this Agreement to be submitted to the FDA jointly by Buyer and Seller pursuant to Section 3.2(c) .
(k) FDC Act means the United States Federal Food, Drug, and Cosmetic Act, 21 USC 301, et seq. as amended, and including any rules, regulations and requirements promulgated thereunder.
(l) 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.
(m) HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and including any rules, regulations and requirements promulgated thereunder.
(n) Knowledge means, with respect to Seller, the actual knowledge of Justin Gover, Chief Executive Officer of GW Pharmaceuticals, plc, Scott Giacobello, Chief Financial Officer of GW Pharmaceuticals, plc, Adam George, Director of GW Research, Ltd. and Dr. Volker Knappertz, Chief Medical Officer of GW Pharmaceuticals, plc, each after performing a reasonable inquiry.
(o) 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, obligations, parameters and conditions relating to the Priority Review Voucher set forth in (i) the NDA Approval Letter, (ii) any other correspondence received by Seller or its Affiliates from the FDA regarding the Priority Review Voucher, (iii) Section 529 of the FDC Act (21 USC 360ff), or (iv) the November 17, 2014 FDA draft guidance document, Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry.
(p) 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 Order and those arising under any Contract.
(q) NDA Approval Letter means the New Drug Application ( NDA ) approval letter dated June 25, 2018 from the Department of Health and Human Services to Seller, Reference ID: 4282447, regarding NDA 210365 for Epidiolex® (cannabidiol) 100 mg/mL oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older, and granting the Priority Review Voucher. A copy of the NDA Approval Letter is attached hereto as Exhibit A .
(r) Notice of Intent to Use means notification to the FDA not later than ninety (90) days prior to the submission of a human drug application as defined in section 735(1) of the FDC Act (21 U.S.C. 379g(1)) of the intent to use a Priority Review Voucher for the human drug application, as described in section 529(b)(4) of the FDC Act (21 U.S.C. § 360ff(b)(4)).
(s) Order means any order, decree, edict, injunction, writ, award or judgment of any Governmental Entity.
(t) Person means any natural person, company, corporation, limited liability company, general partnership, limited partnership, trust, proprietorship, joint venture, business organization or Governmental Entity.
(u) Priority Review means review and action by the FDA on a human drug application not later than six months after receipt by the FDA of such application, as defined in Section 529(a)(1) of the FDC Act.
(v) Priority Review Fe e has the meaning set forth in Section 12.3 .
(w) Priority Review Voucher means the priority review voucher issued by the United States Department of Health and Human Services to Seller, as the sponsor of a rare pediatric disease product application, and assigned tracking number PRV NDA 210365, that entitles the holder of such voucher to Priority Review of a single human drug application submitted under section 505(b)(1) of the FDC Act or Section 3511(a) of the United States Public Health Service Act, as further defined in section 529(a)(2) of the FDC Act (21 USC 360ff(a)(2)), as evidenced by the NDA Approval Letter.
(x) Proceeding means any claim, action, arbitration, audit, hearing, investigation, litigation, proceeding 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.
(y) Purchase Price has the meaning set forth in Section 2.2 .
(z) Regulatory Change means any (i) new Legal Requirement, amendment, or supplement to any then-existing Legal Requirement, or (ii) new, amended, or supplemented term or condition imposed on the Priority Review Voucher that is not set forth in the NDA Approval Letter, that in either case of (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, transfer or otherwise exploit the Priority Review Voucher.
(aa) 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.
(bb) Third Party means any Person other than a Party and such Partys Affiliates.
(cc) Transferred Rights means (i) the Priority Review Voucher, and (ii) any and all rights, benefits and entitlements afforded to the holder of the Priority Review Voucher.
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.
ARTICLE II
PURCHASE AND SALE
2.1 Purchase and Sale ; No Assumed Liabilities .
(a) Upon the terms and subject to the conditions of this Agreement, at and as of the Closing, Buyer shall purchase from Seller, and Seller shall sell, transfer, convey, assign and deliver to Buyer, at the Closing, all of the Transferred Rights, in each case free and clear of all Encumbrances.
(b) Buyer shall not assume or be liable for any Liabilities of Seller or its Affiliates (fixed, contingent or otherwise, and whether or not accrued) in connection with the PRV Transfer (such Liabilities, Excluded Liabilities ).
2.2 Purchase Price . The total consideration to be paid by Buyer at the Closing for all of the Transferred Rights shall be ONE HUNDRED FIVE MILLION U.S. DOLLARS (U.S. $105,000,000.00) (the Purchase Price ).
2.3 Method of Payment . All payments 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 at least three (3) Business Days prior to the applicable payment date.
ARTICLE III
CLOSING
3.1 Closing . The consummation of the PRV Transfer contemplated by this Agreement (the Closing ) shall be conducted telephonically and/or via email or other similar means of correspondence on the third (3 rd ) Business Day after all of the conditions set forth in ARTICLE VII have been satisfied or waived (other than those conditions to be satisfied only by the delivery of certificates or other documents at the Closing, but subject to satisfaction or waiver of such condition) or such other date as may be mutually agreed upon by Buyer and Seller. The date on which the Closing actually takes place is referred to in this Agreement as the Closing Date .
3.2 Transactions to be Effected at Closing .
(a) At the Closing, Seller shall deliver, or cause to be delivered, to Buyer:
(i) the item referred to in Section 7.2(c) , appropriately executed;
(ii) a duly executed Bill of Sale, substantially in the form attached hereto as Exhibit B (the Bill of Sale ); and
(iii) a copy of the joint FDA notification cover letter and the Seller transfer acknowledgement letter for inclusion in the FDA Notification Package, which FDA cover letter and Seller transfer acknowledgement letter shall be in the form of Exhibit C-1 and Exhibit C-2 , respectively, or such other form as the FDA may require as of the Closing Date.
(b) At the Closing, Buyer shall deliver, or cause to be delivered, to Seller:
(i) the item referred to in Section 7.3(c) , appropriately executed;
(ii) a duly executed Bill of Sale;
(iii) payment of the Purchase Price, by wire transfer of immediately available funds to an account or accounts designated in writing by Seller to Buyer, such designation to occur at least three (3) Business Days prior to the Closing Date; and
(iv) a copy of the joint FDA notification cover letter and the Buyer transfer acknowledgement letter for inclusion in the FDA Notification Package, which FDA cover letter and Buyer transfer acknowledgement letter shall be in the form attached hereto as Exhibit C-1 and Exhibit C-3 , respectively, or such other form as the FDA may require as of the Closing Date.
(c) On the Closing Date, Buyer and Seller shall submit the fully executed FDA Notification Package to the FDA.
3.3 Title Passage; Notification .
(a) Title Passage . Upon the Closing, all of the right, title and interest of Seller in and to the Transferred Rights shall pass to Buyer.
(b) Filings; Notifications . 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 Transferred Rights.
ARTICLE IV
PRE-CLOSING NOTIFICATION OF INTENT TO USE THE PRIORITY REVIEW VOUCHER
4.1 Pre-Closing Notification . Buyer may, on or after the Effective Date and prior to Closing, submit a Notice of Intent to Use the Priority Review Voucher substantially in the form attached hereto as Exhibit F to the FDA of its intent to use the Priority Review Voucher to obtain Priority Review of a human
drug application of Buyers choice in accordance with the applicable provisions of the FDC Act and the Priority Review Voucher (a Pre-Closing PRV Notice ).
(a) Upon the Effective Date, Seller shall deliver, or cause to be delivered, to Buyer a letter, substantially in the form set forth on Exhibit D hereto and duly executed by Seller, addressed to the FDA confirming the Parties agreement, subject to approval under the HSR Act, to transfer the Priority Review Voucher to Buyer and confirming that Seller has authorized Buyer to submit a Pre-Closing PRV Notice.
(b) Buyer may submit a copy of the letter referred to in Section 4.1(a) to the FDA together with, or in support of, any Pre-Closing PRV Notice.
(c) Buyer shall notify Seller within three (3) Business Days of (i) any Pre-Closing PRV Notice given to the FDA and (ii) the date falling at least ninety (90) days after the date of such Pre-Closing PRV Notice that is specified by Buyer in a notice to the FDA as being the date on which Buyer intends to submit its new drug application to which that Pre-Closing PRV Notice relates (the Target PRV Use Date ). For the avoidance of doubt, subject to the requirements of the FDC Act and the Approval Letter, the Target PRV Use Date shall be determined by Buyer in Buyers sole discretion.
(d) The Parties shall, or shall cause their respective Affiliates to, keep the other Party reasonably apprised of the status of any communications with, and any inquiries or requests for additional information from, the FDA in connection with any Pre-Closing PRV Notice. The Parties acknowledge and agree that (i) neither Party makes any representation or warranty that the FDA will accept the submission by Buyer prior to the Closing of such Pre-Closing PRV Notice or otherwise agree that such submission by Buyer prior to the Closing will allow the Buyer to submit a human drug application as defined in section 735(1) of the FDC Act (21 U.S.C. 379g(1)) for Priority Review within 90 days of submission by Buyer prior to the Closing of such Pre-Closing PRV Notice and (ii) it is not a condition to either Partys obligation to consummate the Closing that the FDA has so accepted such submission by Buyer or otherwise so agreed that such submission by Buyer will so allow Buyer to so submit such human drug application.
4.2 Withdrawal of Pre-Closing Notification . Without prejudice to Buyers discretion to withdraw a Notice of Intent to Use the Priority Review Voucher at any time by notice to the FDA, the Parties acknowledge and agree that Buyer may withdraw any Pre-Closing PRV Notice if Closing has not occurred by the date that is forty-five (45) days from the Effective Date.
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represent s and warrants to Buyer, as of the Effective Date and as of the Closing Date (except, in each case, to the extent such representations and warranties speak expressly as of a different date, and then, as of such date), as follows:
5.1 Organization, Standing and Power . Seller is a limited company duly organized and validly existing under the laws of England and Wales. Seller has the company 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 Transferred Rights or Sellers ability to consummate the transactions contemplated by this Agreement. Seller is not in violation of its organizational or governing documents, in each case as amended to date.
5.2 Due Authority . Seller has the requisite company 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 PRV Transfer, have been duly and validly approved and authorized by all necessary company 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.
5.3 Noncontravention . 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 Transferred Rights, will not, (a) result in the creation of any Encumbrance on any of the Transferred Rights 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 organizational or governing documents of Seller, in each case as amended to date, (ii) any Contract to which Seller or any Affiliate of Seller is a party or by which it or its assets are bound which involves or affects in any way any of the Transferred Rights or (iii) except as may be required to comply with the HSR Act, any Legal Requirements applicable to Seller or any Affiliate of Seller or any of the Transferred Rights (except, in the case of clauses (ii) and (iii) above, as would not, individually or in the aggregate, have a material adverse effect on the ability of Seller to consummate the sale of the Transferred Rights at Closing and perform its other obligations under this Agreement).
5.4 No Consents . Except for the submission to the FDA of the FDA Notification Package referenced in Section 3.2(c) 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.
5.5 Title to Transferred Rights . Seller is the sole and exclusive owner of the Transferred Rights and owns and at the Closing will transfer to Buyer good and transferable title to the Transferred Rights free and clear of any Encumbrances. Seller has the full right to sell, transfer, convey, assign and deliver the Transferred Rights to Buyer at the Closing, free and clear of any Encumbrances. Seller has performed all actions necessary to perfect its ownership of, and its ability to transfer, the Transferred Rights.
5.6 Contracts . 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 Transferred Rights.
5.7 Compliance With Legal Requirements . Seller and its Affiliates are, and at all times have been, in compliance in all material respects with each Legal Requirement that is or was applicable to (a) Sellers and its Affiliates conduct, acts, or omissions with respect to any of the Transferred Rights or (b) any of the Transferred Rights. 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.
5.8 Legal Proceedings . There is no pending, or to Sellers 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 Transferred Rights. None of the Transferred Rights are subject to any Order of any Governmental Entity or arbitrator.
5.9 Governmental Authorizations . Seller is not required to hold any license, registration, or permit issued by any Governmental Entity to own, use or transfer the Transferred Rights, other than such licenses, registrations or permits that have already been obtained.
5.10 Solvency . 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.
5.11 Revocation; Use of Transferred Rights . The Priority Review Voucher has not been redeemed, transferred, terminated, cancelled or revoked, and neither Seller nor any of its Affiliates or any of their respective Representatives has taken or omitted to take any action, and to Sellers Knowledge there are no facts or circumstances, that would reasonably be expected to (with or without notice or lapse of time or both) result in the termination, cancellation or revocation of the Priority Review Voucher. Seller is not aware or in the possession of any information that would preclude or interfere with Buyers ability to use the Transferred Rights to obtain Priority Review or any other benefit associated with the Transferred Rights following the Closing. There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the NDA Approval Letter or Section 529 of the FDC Act. Seller has provided to Buyer true and complete copies of the NDA Approval Letter and all other communications between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher.
5.12 Marketed 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 and has marketed such product in the United States since such initiation.
5.13 Intent to Use . Neither Seller nor any of its Affiliates has filed or submitted to the FDA a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review.
5.14 No Broker . Seller has not engaged, retained or entered into an agreement with any investment banker, broker, finder or other intermediary who has been authorized to act on behalf of Seller who would be entitled to any fee or commission payable by Buyer in connection with the transactions contemplated by this Agreement.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES OF BUYER
Buyer represents and warrants to Seller as follows:
6.1 Organization, Standing and Power . Buyer is a company duly organized and validly existing business company limited under the laws of the British Virgin Islands. 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 Buyers ability to consummate the transactions contemplated by this Agreement. Buyer is not in violation of its memorandum and articles of association, in each case as amended to date.
6.2 Authority . 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 PRV Transfer, 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.
6.3 Noncontravention . 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 memorandum and articles of association of Buyer, in each case as amended to date, (b) any Contract to which Buyer or any Affiliate of Buyer is a party or by which it or its assets are bound or under which Buyer or any Affiliate of Buyer has material rights or benefits or (c) except as may be required to comply with the HSR Act, any Legal Requirements applicable to Buyer, except, in the case of clauses (b) and (c), as would not reasonably, individually or in the aggregate, be expected to adversely affect the ability of Buyer to consummate the transactions contemplated by this Agreement.
6.4 No Consents . Except for the submission to the FDA of the FDA Notification Package referenced in Section 3.2(c) 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.
6.5 No Broker . Buyer has not engaged, retained or entered into an agreement with any investment banker, broker, finder or other intermediary who has been authorized to act on behalf of Buyer who would be entitled to any fee or commission payable by Seller in connection with the transactions contemplated by this Agreement.
6.6 Financing . Buyer has sufficient funds to consummate the transactions contemplated by this Agreement.
ARTICLE VII
CONDITIONS TO CLOSING
7.1 Conditions Precedent of Buyer and Seller . Each Partys 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.
(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.
7.2 Buyers 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 ARTICLE V (other than the representations and warranties made by Seller in Sections 5.1 , 5.2 , 5.5 , 5.8 , 5.9 , 5.11 , 5.12 and 5.13 ) 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), 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 adversely impact the manner in which Buyer may use, receive, hold, transfer or otherwise exploit the Transferred Rights. Each of the representations and warranties made by Seller in Sections 5.1 , 5.2 , 5.5 , 5.8 , 5.9 , 5.11 , 5.12 and 5.13 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 7.2(a) and 7.2 (b) have been satisfied.
(d) No Regulatory Change . There shall not have occurred and remain in effect any Regulatory Change.
7.3 Sellers 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).
(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 7.3(a) and 7.3(b) have been satisfied.
ARTICLE VIII
PRE-CLOSING COVENANTS AND AGREEMENTS
8.1 Antitrust Notification .
(a) Seller and Buyer shall file, or shall cause their ultimate parent entities as defined in the HSR Act and its implementing rules thereto to file, as soon as practicable (but not later than seven (7) 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, (i) 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 (ii) 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.
(b) Subject to applicable confidentiality restrictions or restrictions required by applicable Legal Requirements, each Party will notify the other promptly upon the receipt of (i) any comments or questions from any Governmental Entity in connection with any filings made pursuant to Section 8.1 or the transactions contemplated by this Agreement and (ii) 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 others respective advisors) upon request copies of all correspondence between such Party and any Governmental Entity relating to the transactions contemplated by this Agreement. 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.
(c) Notwithstanding 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.
8.2 No Solicitation . During the period from the Effective Date and continuing until the earlier of the termination of this Agreement or the Closing Date, Seller shall not, nor shall it authorize, instruct, or permit any of its Affiliates or any of their respective Representatives to, (i) solicit, initiate, or encourage the submission of, any proposal or indication of interest relating to an Alternative Transaction or any inquiry, proposal or offer that is reasonably likely to lead to an Alternative Transaction, (ii) participate in any discussions or negotiations regarding, or furnish to any person any information with respect to, or take any other action to facilitate any inquires or the making of any proposal that constitutes, or may reasonably be expected to lead to, any Alternative Transaction, (iii) accept any proposal or offer from any Person in respect of an Alternative Transaction, or (iv) resolve to propose or agree to do any of the foregoing. Upon the execution of this Agreement, Seller and its Affiliates shall immediately cease and cause to be terminated any existing discussions with any Person that are in respect of an Alternative Transaction.
ARTICLE IX
INDEMNIFICATION
9.1 Indemnification .
(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 Damages to the extent arising out of or resulting from (i) any breach of Sellers representations, warranties, covenants or obligations under this Agreement or any certificate delivered by Seller hereunder, (ii) Sellers 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 to the extent arising out of or resulting from (i) any breach of Buyers representations, warranties, covenants or obligations under this Agreement or any certificate delivered by Buyer hereunder, (ii) Buyers grossly negligent and/or wrongful acts, omissions or misrepresentations, regardless of the form of action, in connection with this Agreement, and/or (iii) Buyers, its Affiliates, or any subsequent transferees use of the Transferred Rights after Closing.
9.2 Indemnification Procedures for Third Party Claims .
(a) A Person entitled to indemnification pursuant to Section 9.1 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 indemnifiable Damages arising out of a claim by a Third Party in respect of which an Indemnitee may seek indemnification pursuant to Section 8.1 (a Third Party Claim ) as soon as reasonably practicable after the Third Party 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 within thirty (30) days of receipt of the Third Party Claim the Indemnitors responsibility for defending such Third Party Claim, the Indemnitor shall have the right to defend, at its sole cost and expense, such Third Party 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 Third Party Claim; and (ii) the Indemnitee consents to such compromise or settlement, which consent shall not be withheld or delayed unless such compromise or settlement 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. If the Indemnitor does not elect to assume control of the defense of a Third Party Claim or 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 Third Party 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), provided , that the Indemnitee shall keep the Indemnitor apprised of all material developments with respect to such Third Party 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. 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 Third Party Claim controlled by the Indemnitor pursuant to this Section 9.2 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.
9.3 Direct Claims . A claim for indemnification for any matter not involving a Third Party Claim may be asserted by written notice to the Party from whom indemnification is sought. Such notice shall include the facts constituting the basis for such claim for indemnification, the Sections of this Agreement upon which such claim for indemnification is then based, and an estimate, if possible, of the amount of Damages suffered or reasonably expected to be suffered by the Indemnitee.
9.4 Buyer Knowledge . The right to indemnification pursuant to this Article IX shall not be affected by any investigation conducted or any knowledge acquired by Buyer, its Affiliates or Representatives at any time, whether before or after the execution and delivery of this Agreement or the Closing, with respect to the accuracy or inaccuracy of, or compliance with, any representation, warranty, covenant, or obligation.
ARTICLE X
TERMINATION
10.1 Termination 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 one hundred twenty (120) days from the Effective Date for any reason; provided , however , that the right to terminate this Agreement under this Section 10.1(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.
10.2 Effect of Termination . In the event of the termination of this Agreement as provided in Section 10.1 , 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 10.2 , Section 11.4 , ARTICLE I and ARTICLE XII , 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 prior to termination of this Agreement by Buyer or Seller. If this Agreement is terminated, Buyer will promptly withdraw any Pre-Closing PRV Notice submitted to the FDA prior to the Closing.
ARTICLE XI
ADDITIONAL COVENANTS
11.1 Further 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 any notifications or filings required to be made to the FDA in connection with the transfer of the Transferred Rights, 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 and/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 Transferred Rights.
11.2 Compliance with Legal Requirements . Seller shall, and shall cause its Affiliates and each of their respective successors in interest to the rare pediatric disease product for which the Priority Review Voucher was awarded to, at all times comply with all Legal Requirements applicable to the Transferred Rights, including any and all Legal Requirements applicable to the use or transfer of the Priority Review Voucher. Seller shall promptly forward to Buyer any communications or notices it or its Affiliates receive from any Governmental Entity to the extent relating to the Transferred Rights (and not otherwise with respect to the product approved in the NDA Approval Letter). Without limiting the generality of the foregoing, to the extent required, now or in the future, under applicable Legal Requirements or otherwise by the FDA for the use or transfer of the Priority Review Voucher, or to avoid revocation of the Priority Review Voucher, Seller shall, and shall cause its Affiliates and each of their respective successors in interest to the rare pediatric disease product for which the Priority Review Voucher was awarded, to submit a post-approval production report to the United States Secretary of Health and Human Services not later than five (5) years after the approval of such rare pediatric disease product in accordance with section 529(e)(2) of the FDC Act.
11.3 Marketing . Seller will 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, now or in the future, under applicable Legal Requirements or otherwise by any applicable Governmental Entity for the use or transfer of the Priority Review Voucher.
11.4 Nondisclosure .
(a) With respect to Confidential Information received from a Party, the other Party will (i) not use such Confidential Information for any reason other than to carry out the intent and purpose of this Agreement, and (ii) not disclose such 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) A Party may disclose Confidential Information to its Affiliates and their respective Representatives on a need-to-know basis.
(c) A Party will (i) enforce the terms of this Section 11.4 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 11.4 , and (iii) be responsible and liable for any breach of this Section 11.4 by it or its Representatives.
(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 11.4 , 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 11.4 . 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.
11.5 Disclosures Concerning this Agreement . 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 (i) the Buyer and Seller shall each be entitled to issue a press release with respect to the execution of this Agreement, in a form attached as Exhibit E-1 and Exhibit G hereto, respectively, and (iii) 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 Partys (or its parent entitys) securities are traded); provided that the Party intending to disclose such information shall provide the other Party with advance notice of such required disclosure, and provide the other Party a reasonable opportunity to review and comment on such proposed disclosure (which comments shall be considered in good faith by the disclosing Party). Each Party acknowledges that the other Party, or the other Partys 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 (the SEC ). Without limiting the foregoing, any Party so obligated shall request confidential treatment of this Agreement pursuant to applicable rules under the Securities Exchange Act of 1934, as amended, and the Freedom of Information Act and the rules promulgated thereunder to permit the filing of a redacted exhibit, provided that there is no assurance that such request will be granted by the SEC and the SEC may require filing of the Agreement in full. 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.
ARTICLE XII
GENERAL PROVISIONS
12.1 Survival . 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 two (2) years following the Closing Date; provided , however , that the representations and warranties contained in Sections 5.1 , 5.2 , 5.5 , 5.11 , 5.12 and 5.13 hereof, shall, in each case, survive the Closing Date and remain in full force and effect until the expiration of the applicable statute of limitations.
12.2 Transfer Taxes and Fees . Notwithstanding any other provision in this Agreement to the contrary, each respective Party shall bear and pay any and all sales taxes, value added taxes, use taxes, transfer taxes, documentary charges, recording fees or similar taxes, charges, or fees (including any
penalties, interest and additions thereto) that may become payable by it or its Affiliates in connection with the PRV Transfer.
12.3 Priority Review Fee . The priority review user fee described in section 529(c) of the FDC Act (21 U.S.C. § 360ff(c)) (the Priority Review Fee ) and all other user fees under the FDC Act applicable to the human drug application for which the Priority Review Voucher is redeemed, following the Closing shall be borne exclusively by the Buyer, its Affiliates or any transferee of the Priority Review Voucher. In any event, Seller shall have no liability or obligation for any such fees. In furtherance and not in limitation of the foregoing, Buyer shall timely pay all amounts due with respect to the Priority Review Fee in connection any submission of a Pre-Closing PRV Notice as contemplated by Section 4.1 or other Notice of Intent to Use the Priority Review Voucher by Buyer.
12.4 Notices . 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; or (b) upon such Partys receipt after being sent by registered mail, by courier or express delivery service, in any case to the address 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 12.3 ):
(i) if to Buyer, to:
Biohaven Pharmaceutical Holding Ltd
215 Church Street
New Haven, CT 06510
Attn: Chief Executive Officer
Email: vlad.coric@biohavenpharma.com
with a copy (which shall not constitute notice) to:
Cooley LLP
One Freedom Square
Reston Town Center
11951 Freedom Drive
Reston, VA 20190-5656
Attn: Darren DeStefano
Email: ddestafano@cooley.com
Fax: (703) 456-8100
(ii) if to Seller, to:
GW Pharmaceuticals, plc
Sovereign House
Vision Park
Histon
Cambridge CB24 9BZ
United Kingdom
Attn Adam George, Managing Director UK
Email: ageorge@gwpharm.com
and to:
Greenwich Biosciences, Inc.
5750 Fleet Street, Suite 200
Carlsbad, CA 92008
Attn Douglas Snyder, Chief Legal Officer
Email: DSnyder@greenwichbiosciences.com
with a copy (which shall not constitute notice) to:
Covington & Burling LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018-1405
Attn: Stephen A. Infante
Email: sinfante@cov.com
12.5 Construction .
(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.
(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.
12.6 Counterparts . 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.
12.7 Entire 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.
12.8 Assignment . No Party will have the right to assign this Agreement, in whole or in part, by operation of law or otherwise, without the other Partys 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 Sellers consent, to any purchaser, transferee, or assignee of any of the Transferred Rights. For the avoidance of doubt, no assignment made pursuant to this Section 12.7 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 Partys successors and permitted assigns.
12.9 Severability . 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.
12.10 Remedies 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.
12.11 Governing 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.
12.12 Amendment; Extension; Waiver . Subject to the provisions of applicable law, 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.
12.13 Representation 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.
12.14 Expenses . Whether or not the purchase and sale of the Transferred Rights and the other transactions contemplated by this Agreement are consummated, and except as otherwise set forth in this Agreement, each of the Parties shall bear its own fees and expenses incurred in connection with this Agreement and the transactions contemplated hereby.
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IN WITNESS WHEREOF, each of Buyer and Seller has caused this PRV Transfer Agreement to be executed and delivered by their respective officers thereunto duly authorized, all as of the date first written above.
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GW RESEARCH, LTD. |
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Adam George |
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BIOHAVEN SECURES PRIORITY REVIEW VOUCHER (PRV) TO EXPEDITE REGULATORY REVIEW OF RIMEGEPANT ZYDIS ODT NEW DRUG APPLICATION
· Rimegepant Zydis orally disintegrating tablet (ODT) is Biohavens lead oral CGRP receptor antagonist drug candidate from its NOJECTION migraine platform
· A priority review voucher (PRV) entitles the holder to designate a New Drug Application (NDA) for priority review and provides for an expedited 6-month review
· The purchase of the PRV, and additional funding for general corporate uses, was funded by a sale of preferred stock to Royalty Pharma
NEW HAVEN, Conn., March 18, 2019 /PRNewswire/ Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the company has purchased a U.S. Food and Drug Administration (FDA) priority review voucher (PRV) to use with the NDA submission of rimegepant Zydis â ODT in the second quarter of 2019. The PRV entitles the holder to designate an NDA for priority review and provides for an expedited 6-month review.
Vlad Coric, M.D, Chief Executive Officer of Biohaven commented, This transaction highlights the important benefits to patients of the priority review voucher program the program motivates more treatments to be developed for rare pediatric diseases and also speeds approval of potential blockbuster therapies. Millions of patients suffer from debilitating migraines and have long awaited new treatment approaches such as an easy to use oral CGRP receptor antagonist. We are excited about the potential of bringing rimegepant Zydis ODT to patients as quickly as possible.
Biohaven entered into a definitive agreement to purchase the PRV for $105M. The closing of the transaction is subject to customary closing conditions, including antitrust review. In addition to the purchase of the PRV, the company also announced an agreement to raise a total of up to $200M in financing for the purchase of this PRV and general corporate uses. The financing is being provided by the sale of preferred shares to Royalty Pharma and is subject to customary closing conditions. Royalty Pharma will provide $125M at closing and allow the company to draw up to an additional $75M upon FDA acceptance of the rimegepant NDA.
Pablo Legorreta, CEO of Royalty Pharma stated, We are pleased to further support Biohaven in the development of rimegepant. In a matter of days, we worked collaboratively with Biohaven to assist in funding the strategically important acquisition of a PRV. We are providing up to $200m of capital with a structured return that is potentially less dilutive than other alternatives. This financing is highly flexible and responsive to the many potential future paths for a dynamic company like Biohaven.
Biohaven previously announced positive topline results from a randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the efficacy and safety of its Zydis ODT formulation of rimegepant. Rimegepant Zydis ODT was statistically superior to placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures pre-specified in hierarchical testing. Importantly, the performance of the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes after dosing, and this difference was statistically significant at 60 minutes (p < 0.0001). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60
minutes as compared to placebo (p = 0.0025). Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.0001), pain relief (p < 0.0001), freedom from the most bothersome symptom (p = 0.0018), and freedom from functional disability (p < 0.0001). The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.
About Rimegepant
Rimegepant is Biohavens orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA) and provide the basis for a planned submission of a new drug application (NDA) to the FDA in the second quarter of 2019.
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohavens lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com .
About Royalty Pharma
Founded in 1996, Royalty Pharma is the industry leader in acquiring pharmaceutical royalties, with over $16 billion in royalty assets. Royalty Pharma funds innovation in life sciences both directly and indirectly: directly when it partners with life sciences companies to co-develop and co-fund products in late-stage clinical trials, and indirectly when it acquires existing royalty interests from the original innovators (academic institutions, research hospitals, foundations and inventors). The companys portfolio includes royalty interests in over 40 approved products including AbbVie and J&Js Imbruvica, Astellas and Pfizers Xtandi, Biogens Tysabri, Gileads HIV franchise, Mercks Januvia, and Vertexs cystic fibrosis franchise. Royalty Pharma is also a leading investor in pre-approval royalties, having since 2011 invested over $4 billion in royalties on pre-approval products and committed over $900 million to direct R&D funding in exchange for royalties. More information on Royalty Pharma is available at www.royaltypharma.com.
Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Companys management. All statements, other than statements of historical facts, included in this press release regarding the Companys business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing, commencement and outcomes of the Companys planned and ongoing clinical trials, the
timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the expected issuance of preferred stock to Royalty Pharma, the potential commercialization of the Companys product candidates and the potential for the Companys product candidates to be first in class or best in class therapies. The use of certain words, including believe, continue, may, on track, expects and will and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the Risk Factors section of the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact Dr. Vlad Coric, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com