|
British Virgin Islands
(State or other jurisdiction of
incorporation or organization)
|
Not applicable
(I.R.S. Employer
Identification Number)
|
Large accelerated filer
|
x
|
|
Accelerated filer
|
¨
|
Non-accelerated filer
|
¨
|
|
Smaller reporting company
|
¨
|
|
|
|
Emerging growth company
|
¨
|
|
|
Title of each class of
securities to be registered
|
Amount to be registered (1)
|
Proposed maximum offering price per unit (1)
|
Proposed maximum aggregate offering price (1)
|
Amount of registration fee(2)
|
Common Shares, no par value
|
|
|
|
|
Preferred Shares, no par value
|
|
|
|
|
Depositary Shares
|
|
|
|
|
Debt Securities
|
|
|
|
|
Warrants
|
|
|
|
|
Rights
|
|
|
|
|
Purchase contracts
|
|
|
|
|
Units
|
|
|
|
|
Total
|
|
|
|
|
(1)
|
Omitted pursuant to General Instruction II.E to Form S-3 under the Securities Act of 1933, as amended (the “Securities Act”). An unspecified aggregate initial offering price and number or amount of the securities of each identified class of securities is being registered for possible offering from time to time at indeterminate prices. Pursuant to Rule 416(a) under the Securities Act, this registration statement shall be deemed to cover any additional number of securities that may be offered or issued from time to time upon share splits, share dividends, recapitalizations or similar transactions. The proposed maximum offering price per security will be determined from time to time by the registrant in connection with, and at the time of, offering by the registrant of the securities registered hereby. Separate consideration may or may not be received for securities that are issuable on exercise, conversion or exchange of other securities or that are offered in units. Securities may be denominated in U.S. dollars or the equivalent thereof in foreign currency or currency units.
|
(2)
|
In accordance with Rules 456(b) and 457(r) of the Securities Act, the Registrant is deferring payment of all of the registration fee.
|
|
|
|
|
|
|
•
|
our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the SEC on February 28, 2019;
|
•
|
our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, filed with the SEC on May 8, 2019;
|
•
|
our Current Reports on Form 8-K filed with the SEC on March 18, 2019, April 8, 2019 and May 22, 2019; and
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•
|
the description of our common shares contained in our Registration Statement on Form 8-A filed on May 1, 2017 and any amendments or reports filed with the SEC for the purpose of updating the description.
|
•
|
is or was a party or is threatened to be made a party to any threatened, pending or completed proceedings, whether civil, criminal, administrative or investigative, by reason of the fact that the person is or was our director; or
|
•
|
is or was, at our request, serving as a director or officer of, or in any other capacity is or was acting for, another body corporate or a partnership, joint venture, trust or other enterprise.
|
•
|
the exchange or conversion rate per preferred share, multiplied by the fraction or multiple of a preferred share represented by one depositary share;
|
•
|
plus all money and any other property represented by one depositary share; and
|
•
|
including all amounts per depositary share paid by us for dividends that have accrued on the preferred shares on the exchange or conversion date and that have not been paid.
|
•
|
all outstanding depositary shares have been redeemed or converted or exchanged for any other securities into which they or the underlying preferred shares are convertible or exchangeable;
|
•
|
each share of preferred shares has been converted into or exchanged for common shares; or
|
•
|
a final distribution in respect of the preferred shares has been made to the holders of depositary receipts in connection with our liquidation, dissolution or winding-up.
|
•
|
we and the depositary are only liable to the holders of depositary receipts for negligence or willful misconduct;
|
•
|
we and the depositary have no obligation to become involved in any legal or other proceeding related to the depositary receipts or the deposit agreement on your behalf or on behalf of any other party, unless you provide us with satisfactory indemnity; and
|
•
|
we and the depositary may rely upon any written advice of counsel or accountants and on any documents we believe in good faith to be genuine and to have been signed or presented by the proper party.
|
•
|
the title and ranking of the debt securities (including the terms of any subordination provisions);
|
•
|
the price or prices (expressed as a percentage of the principal amount) at which we will sell the debt securities;
|
•
|
the aggregate principal amount of the debt securities being offered and any limit on the aggregate principal amount of such series of debt securities;
|
•
|
whether any of our direct or indirect subsidiaries will guarantee the debt securities, including the terms of subordination, if any, of such guarantees;
|
•
|
the date or dates on which the principal of the securities of the series is payable;
|
•
|
the interest rate, if any, and the method for calculating the interest rate;
|
•
|
the dates from which interest will accrue, the interest payment dates and the record dates for the interest payments;
|
•
|
the place or places where principal of, and any interest on, the debt securities will be payable (and the method of such payment), where the securities of such series may be surrendered for registration of transfer or exchange, and where notices and demands to us in respect of the debt securities may be delivered;
|
•
|
any mandatory or optional redemption terms;
|
•
|
any obligation we have to redeem or purchase the debt securities pursuant to any sinking fund or analogous provisions or at the option of a holder of debt securities and the period or periods within which, the price or prices at which and the terms and conditions upon which securities of the series shall be redeemed or purchased, in whole or in part, pursuant to such obligation;
|
•
|
any dates, if any, on which and the price or prices at which we will repurchase debt securities at the option of the holders of debt securities and other detailed terms and provisions of such repurchase obligations;
|
•
|
the denominations in which the debt securities will be issued;
|
•
|
whether the debt securities will be issued in the form of certificated debt securities or global debt securities;
|
•
|
the currency of denomination of the debt securities, which may be U.S. dollars or any foreign currency, and if such currency of denomination is a composite currency, the agency or organization, if any, responsible for overseeing such composite currency;
|
•
|
the designation of the currency, currencies or currency units in which payment of the principal of, and any interest on, the debt securities will be made;
|
•
|
if payments of principal of, any interest on, the debt securities will be made in one or more currencies or currency units other than that or those in which the debt securities are denominated, the manner in which the exchange rate with respect to such payments will be determined;
|
•
|
the manner in which the amounts of payment of principal of, or any interest on, the debt securities will be determined, if these amounts may be determined by reference to an index based on a currency or currencies or by reference to a commodity, commodity index, stock exchange index or financial index;
|
•
|
any provisions relating to any security provided for the debt securities;
|
•
|
any addition to, deletion of or change in the events of default described in this prospectus or in the indenture with respect to the debt securities and any change in the acceleration provisions described in this prospectus or in the indenture with respect to the debt securities;
|
•
|
any addition to, deletion of or change in the covenants described in this prospectus or in the indenture with respect to the debt securities;
|
•
|
any depositaries, interest rate calculation agents, exchange rate calculation agents or other agents appointed with respect to the debt securities;
|
•
|
the provisions, if any, relating to conversion or exchange of any series of debt securities, including if applicable, the conversion or exchange price and period, the securities or other property into which the debt securities will be convertible, provisions as to whether conversion or exchange will be mandatory, at the option of the holders thereof or at our option, the events requiring an adjustment of the conversion price or exchange price and provisions affecting conversion or exchange if such series of debt securities are redeemed; and
|
•
|
any other terms of the series of debt securities that may supplement, modify or delete any provision of the indenture as it applies to that series, including any terms that may be required under applicable law or regulations or advisable in connection with the marketing of the debt securities.
|
•
|
Biohaven is the surviving person or the successor person (if other than Biohaven) expressly assumes Biohaven’s obligations on the debt securities and under the indenture; and
|
•
|
immediately after giving effect to the transaction, no default or event of default shall have occurred and be continuing.
|
•
|
default in the payment of any interest upon any debt security of that series when it becomes due and payable, and continuance of such default for a period of 30 days (unless the entire amount of the payment is deposited by us with the trustee or with a paying agent prior to the expiration of the 30-day period);
|
•
|
default in the payment of principal of any security of that series at its maturity;
|
•
|
default in the performance or breach of any covenant by us in the indenture (other than defaults described above or defaults relating to a covenant that has been included in the indenture solely for the benefit of a series of debt securities other than that series), which default continues uncured for a period of 60 days after we receive written notice from the trustee, or we and the trustee receive written notice from the holders of not less than 25% in principal amount of the outstanding debt securities of that series as provided in the indenture;
|
•
|
certain voluntary or involuntary events of bankruptcy, insolvency or reorganization of Biohaven; and
|
•
|
any other event of default provided with respect to a series of debt securities that is described in the applicable prospectus supplement.
|
•
|
that holder has previously given to the trustee written notice of a continuing event of default with respect to debt securities of that series;
|
•
|
the holders of not less than 25% in principal amount of the outstanding debt securities of that series have made written request to the trustee to institute the proceedings in respect of such event of default in its own name as trustee under the indenture;
|
•
|
such holder or holders have offered to the trustee indemnity or security satisfactory to the trustee against the costs, expenses and liabilities which might be incurred by the trustee in compliance with such request;
|
•
|
the trustee has failed to institute any such proceeding for 60 days after its receipt of such notice, request and offer of indemnity; and
|
•
|
no direction inconsistent with such written request has been given to the trustee during such 60-day period by holders of a majority in principal amount of the outstanding debt securities of that series.
|
•
|
to add guarantees with respect to debt securities of a series or secure debt securities of a series;
|
•
|
to surrender any of our rights or powers under the indenture;
|
•
|
to add covenants or events of default for the benefit of the holders of any series of debt securities;
|
•
|
to comply with the applicable procedures of the applicable depositary;
|
•
|
to cure any ambiguity, defect or inconsistency;
|
•
|
to comply with covenants in the indenture described above under the heading “Consolidation, Merger and Sale of Assets”;
|
•
|
to provide for uncertificated securities in addition to or in place of certificated securities;
|
•
|
to make any change that does not materially adversely affect the rights of any holder of debt securities;
|
•
|
to conform any supplement to the indenture for a series of securities or the securities of a series to the description of securities for such series in the prospectus supplement or offering document with respect to such series;
|
•
|
to provide for the issuance of and establish the form and terms and conditions of debt securities of any series as permitted by the indenture;
|
•
|
to effect the appointment of a successor trustee with respect to the debt securities of any series and to add to or change any of the provisions of the indenture to provide for or facilitate administration by more than one trustee;
|
•
|
to comply with requirements of the SEC in order to effect or maintain the qualification of the indenture under the Trust Indenture Act; and
|
•
|
for certain other reasons set forth in any prospectus supplement.
|
•
|
reduce the principal amount of debt securities whose holders must consent to an amendment, supplement or waiver;
|
•
|
reduce the rate of or extend the time for payment of interest (including default interest) on any debt security;
|
•
|
reduce the principal of, or change the fixed maturity of, any debt security or reduce the amount of, or postpone the date fixed for, the payment of any sinking fund or analogous obligation with respect to any series of debt securities;
|
•
|
reduce the principal amount of discount securities payable upon acceleration of maturity;
|
•
|
waive a default in the payment of the principal of, or interest, if any, on any debt security (except a rescission of acceleration of the debt securities of any series by the holders of at least a majority in principal amount of the then outstanding debt securities of that series and a waiver of the payment default that resulted from such acceleration);
|
•
|
make the principal of, or any interest on, any debt security payable in currency other than that stated in the debt security;
|
•
|
make any change to certain provisions of the indenture relating to, among other things, the right of holders of debt securities to receive payment of the principal of, and any interest on, those debt securities and to institute suit for the enforcement of any such payment;
|
•
|
make any change to certain provisions of the indenture relating to waivers or amendments; or
|
•
|
waive a redemption payment with respect to any debt security, provided that such redemption is made at our option.
|
•
|
we may omit to comply with the covenant described under the heading “Consolidation, Merger and Sale of Assets” and certain other covenants set forth in the indenture, as well as any additional covenants which may be set forth in the applicable prospectus supplement; and
|
•
|
any omission to comply with those covenants will not constitute a default or an event of default with respect to the debt securities of that series (“covenant defeasance”).
|
•
|
depositing with the trustee money and/or U.S. government obligations or, in the case of debt securities denominated in a single currency other than U.S. dollars, government obligations of the government that issued or caused to be issued such currency, that, through the payment of interest and principal in accordance with their terms, will provide money in an amount sufficient in the opinion of a nationally recognized firm of independent public accountants or investment bank to pay and discharge each installment of principal of, and interest, if any, on and any mandatory sinking fund payments in respect of the debt securities of that series on the stated maturity of those payments in accordance with the terms of the indenture and those debt securities; and
|
•
|
delivering to the trustee an opinion of counsel to the effect that the holders of the debt securities of that series will not recognize income, gain or loss for United States federal income tax purposes as a result of the deposit and related covenant defeasance and will be subject to United States federal income tax on the same amounts and in the same manner and at the same times as would have been the case if the deposit and related covenant defeasance had not occurred.
|
•
|
the offering price and the aggregate number of warrants offered;
|
•
|
the currencies in which the warrants are being offered;
|
•
|
the designation, aggregate principal amount, currencies, denominations and terms of the series of debt securities that can be purchased if a holder exercises a warrant;
|
•
|
the designation and terms of any series of debt securities with which the warrants are being offered and the number of warrants offered with each such debt security;
|
•
|
the date on and after which the holder of the warrants can transfer them separately from the related series of debt securities;
|
•
|
the terms of any rights to redeem or call the warrants;
|
•
|
the date on which the right to exercise the warrants begins and the date on which that right expires;
|
•
|
federal income tax consequences of holding or exercising the warrants; and
|
•
|
any other specific terms, preferences, rights or limitations of, or restrictions on, the warrants.
|
•
|
the offering price and the aggregate number of warrants offered;
|
•
|
the total number of shares that can be purchased if a holder of the warrants exercises them;
|
•
|
the number of warrants being offered with each common share;
|
•
|
the date on and after which the holder of the warrants can transfer them separately from the related common shares or preferred shares or the related depositary shares;
|
•
|
the amount of common shares, preferred shares, or depositary shares that can be purchased if a holder exercises the warrant and the price at which those shares may be purchased upon exercise, including, if applicable, any provisions for changes to or adjustments in the exercise price and in the securities or other property receivable upon exercise;
|
•
|
the terms of any rights to redeem or call, or accelerate the expiration of, the warrants;
|
•
|
the date on which the right to exercise the warrants begins and the date on which that right expires;
|
•
|
federal income tax consequences of holding or exercising the warrants; and
|
•
|
any other specific terms, preferences, rights or limitations of, or restrictions on, the warrants.
|
•
|
deliver to the warrant agent the payment required by the applicable prospectus supplement to purchase the underlying security;
|
•
|
properly complete and sign the reverse side of the warrant certificate representing the warrants; and
|
•
|
deliver the warrant certificate representing the warrants to the warrant agent within five business days of the warrant agent receiving payment of the exercise price.
|
•
|
issue shares of common shares or preferred shares or other securities convertible into or exchangeable for common shares or preferred shares, or any rights to subscribe for, purchase or otherwise acquire any of the foregoing, as a dividend or distribution to all or substantially all holders of our common shares or preferred shares;
|
•
|
pay any cash to all or substantially all holders of our common shares or preferred shares, other than a cash dividend paid out of our current or retained earnings;
|
•
|
issue any evidence of our indebtedness or rights to subscribe for or purchase our indebtedness to all or substantially all holders of our common shares or preferred shares; or
|
•
|
issue common shares, preferred shares or additional shares or other securities or property to all or substantially all holders of our common shares or preferred shares by way of spinoff, split-up, reclassification, combination of shares or similar corporate rearrangement;
|
•
|
certain reclassifications, capital reorganizations or changes of the common shares or preferred shares;
|
•
|
certain share exchanges, mergers, or similar transactions involving us that result in changes of the common shares or preferred shares; or
|
•
|
certain sales or dispositions to another entity of all or substantially all of our property and assets.
|
•
|
the date for determining the persons entitled to participate in the rights distribution;
|
•
|
the exercise price for the rights;
|
•
|
the aggregate number or amount of underlying securities purchasable upon exercise of the rights;
|
•
|
the number of rights issued to each shareholder and the number of rights outstanding, if any;
|
•
|
the extent to which the rights are transferable;
|
•
|
the date on which the right to exercise the rights will commence and the date on which the right will expire;
|
•
|
the extent to which the rights include an over-subscription privilege with respect to unsubscribed securities;
|
•
|
anti-dilution provisions of the rights, if any; and
|
•
|
any other terms of the rights, including terms, procedures and limitations relating to the distribution, exchange and exercise of the rights.
|
•
|
the price of the securities or other property subject to the purchase contracts (which may be determined by reference to a specific formula described in the purchase contracts);
|
•
|
whether the purchase contracts are issued separately, or as a part of units each consisting of a purchase contract and one or more of our other securities or securities of an unaffiliated entity, including U.S. Treasury securities, securing the holder’s obligations under the purchase contract;
|
•
|
any requirement for us to make periodic payments to holders or vice versa, and whether the payments are unsecured or pre-funded;
|
•
|
any provisions relating to any security provided for the purchase contracts;
|
•
|
whether the purchase contracts obligate the holder or us to purchase or sell, or both purchase and sell, the securities subject to purchase under the purchase contract, and the nature and amount of each of those securities, or the method of determining those amounts;
|
•
|
whether the purchase contracts are to be prepaid or not;
|
•
|
whether the purchase contracts are to be settled by delivery, or by reference or linkage to the value, performance or level of the securities subject to purchase under the purchase contract;
|
•
|
any acceleration, cancellation, termination or other provisions relating to the settlement of the purchase contracts;
|
•
|
a discussion of certain United States federal income tax considerations applicable to the purchase contracts;
|
•
|
whether the purchase contracts will be issued in fully registered or global form; and
|
•
|
any other terms of the purchase contracts and any securities subject to such purchase contracts.
|
•
|
the designation and terms of the units and the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;
|
•
|
any provision for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; and
|
•
|
whether the units will be issued in fully registered or global form.
|
•
|
at a fixed price or prices, which may be changed;
|
•
|
at market prices prevailing at the time of sale;
|
•
|
at prices related to such prevailing market prices; or
|
•
|
at negotiated prices.
|
|
Amount
to
be paid
|
|
SEC registration fee
|
$
|
(1)
|
Listing fees
|
|
(2)
|
Legal fees and expenses
|
|
(2)
|
Fees and expenses of qualification under state securities laws (including legal fees)
|
|
(2)
|
Accountants’ fees and expenses
|
|
(2)
|
Printing fees
|
|
(2)
|
Rating agency fees
|
|
(2)
|
Trustee and depositary fees and expenses
|
|
(2)
|
Miscellaneous
|
|
(2)
|
Total
|
$
|
(2)
|
(1)
|
To be determined. Biohaven is deferring payment of the registration fee in reliance on Rule 456(b) and Rule 457(r) under the Securities Act of 1933.
|
(2)
|
To be determined. These fees are calculated based on the number of issuances and amount of securities offered and accordingly cannot be estimated at this time.
|
•
|
is or was a party or is threatened to be made a party to any threatened, pending or completed proceedings, whether civil, criminal, administrative or investigative, by reason of the fact that the person is or was our director; or
|
•
|
is or was, at our request, serving as a director or officer of, or in any other capacity is or was acting for, another body corporate or a partnership, joint venture, trust or other enterprise.
|
Exhibit
No. |
|
Description of Document
|
1.1 *
|
|
Form of Underwriting Agreement.
|
2.1
|
|
|
2.2
|
|
|
2.3
|
|
|
2.4
|
|
|
3.1
|
|
|
4.1
|
|
|
4.2
|
|
|
4.3
|
|
|
4.4 *
|
|
Form of Depositary Agreement.
|
4.5 *
|
|
Form of Global Note.
|
4.6 *
|
|
Form of Common Share Warrant Agreement and Warrant Certificate.
|
4.7 *
|
|
Form of Preferred Share Warrant Agreement and Warrant Certificate.
|
4.8 *
|
|
Form of Debt Securities Warrant Agreement and Warrant Certificate.
|
4.9 *
|
|
Form of Rights Agreement.
|
4.10 *
|
|
Form of Purchase Agreement.
|
4.11 *
|
|
Form of Unit Agreement and Unit Certificate.
|
5.1
|
|
|
5.2
|
|
|
10.1 #
|
|
|
10.2 #
|
|
|
10.3 #
|
|
10.4
|
|
|
10.5 #
|
|
|
10.6 #
|
|
|
10.7 #
|
|
|
10.8 #
|
|
|
10.9 #
|
|
|
10.10 #
|
|
|
10.11
|
|
|
10.12
|
|
|
10.13
|
|
|
10.14 +
|
|
|
10.15 +
|
|
|
10.16 +
|
|
|
10.17 +
|
|
|
10.18 +
|
|
|
10.19 +
|
|
|
10.20 +
|
|
|
23.1
|
|
|
24.1
|
|
|
25.1 **
|
|
Form T-1 Statement of Eligibility under Trust Indenture Act of 1939 of Trustee under the Indenture.
|
*
|
To be filed by amendment or as an exhibit to a document to be incorporated by reference herein in connection with an offering of the offered securities.
|
**
|
To be filed separately under the electronic form type 305B2.
|
#
|
Certain portions of this exhibit (indicated by asterisks) have been omitted as such information is (i) not material and (ii) would likely cause competitive harm to the Registrant if publicly disclosed.
|
+
|
Indicates management contract or compensatory plan.
|
(1)
|
to file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
(i)
|
to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
|
(ii)
|
to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
|
(iii)
|
to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
|
(2)
|
that, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide
offering thereof.
|
(3)
|
to remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
|
(4)
|
that, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
(i)
|
each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
|
(ii)
|
each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the offering of such securities at that time shall be deemed to be the initial
bona fide
offering thereof.
Provided, however,
that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
|
(5)
|
that, for the purpose of determining liability of the Registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned Registrant undertakes that in a primary offering of securities of the undersigned Registrant pursuant to this registration statement, regardless of the underwriting method used to sell the
|
(i)
|
any preliminary prospectus or prospectus of the undersigned Registrant relating to the offering required to be filed pursuant to Rule 424;
|
(ii)
|
any free writing prospectus relating to the offering prepared by or on behalf of the undersigned Registrant or used or referred to by the undersigned Registrant;
|
(iii)
|
the portion of any other free writing prospectus relating to the offering containing material information about the undersigned Registrant or its securities provided by or on behalf of the undersigned Registrant; and
|
(iv)
|
any other communication that is an offer in the offering made by the undersigned Registrant to the purchaser.
|
(6)
|
that, for purposes of determining any liability under the Securities Act of 1933, each filing of the Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide
offering thereof.
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
|
|
By:
|
/s/ Vlad Coric
|
|
Vlad Coric
|
|
Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Vlad Coric, M.D.
|
|
Chief Executive Officer and Director (Principal Executive Officer)
|
|
June 17, 2019
|
Vlad Coric, M.D.
|
|
|
||
|
|
|
|
|
/s/ James Engelhart
|
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
|
June 17, 2019
|
James Engelhart
|
|
|
||
|
|
|
|
|
/s/ Declan Doogan, M.D.
|
|
Chairman of the Board of Directors
|
|
June 17, 2019
|
Declan Doogan, M.D.
|
|
|
||
|
|
|
|
|
/s/ Eric Aguiar, M.D.
|
|
Director
|
|
June 17, 2019
|
Eric Aguiar, M.D.
|
|
|
||
|
|
|
|
|
/s/ Gregory H. Bailey, M.D.
|
|
Director
|
|
June 17, 2019
|
Gregory H. Bailey, M.D.
|
|
|
||
|
|
|
|
|
/s/ John W. Childs
|
|
Director
|
|
June 17, 2019
|
John W. Childs
|
|
|
||
|
|
|
|
|
/s/ Julia Gregory
|
|
Director
|
|
June 17, 2019
|
Julia Gregory
|
|
|
||
|
|
|
|
|
/s/ Robert Repella, RPh, MBA
|
|
Director
|
|
June 17, 2019
|
Robert Rapella, RPh, MBA
|
|
|
|
|
Page
|
|
ARTICLE I
|
|
||
DEFINITIONS AND INCORPORATION BY REFERENCE
|
|||
Section 1.1
|
Definitions.
|
2
|
|
Section 1.2
|
Other Definitions.
|
5
|
|
Section 1.3
|
Incorporation by Reference of Trust Indenture Act.
|
6
|
|
Section 1.4
|
Rules of Construction.
|
6
|
|
ARTICLE II
|
|
||
THE SECURITIES
|
|
||
Section 2.1
|
Issuable in Series.
|
6
|
|
Section 2.2
|
Establishment of Terms of Series of Securities.
|
7
|
|
Section 2.3
|
Execution and Authentication.
|
9
|
|
Section 2.4
|
Registrar and Paying Agent.
|
10
|
|
Section 2.5
|
Paying Agent to Hold Money in Trust.
|
11
|
|
Section 2.6
|
Securityholder Lists.
|
11
|
|
Section 2.7
|
Transfer and Exchange.
|
11
|
|
Section 2.8
|
Mutilated, Destroyed, Lost and Stolen Securities.
|
12
|
|
Section 2.9
|
Outstanding Securities.
|
13
|
|
Section 2.10
|
Treasury Securities.
|
13
|
|
Section 2.11
|
Temporary Securities.
|
13
|
|
Section 2.12
|
Cancellation.
|
14
|
|
Section 2.13
|
Defaulted Interest.
|
14
|
|
Section 2.14
|
Global Securities.
|
14
|
|
Section 2.15
|
CUSIP Numbers.
|
15
|
|
ARTICLE III
|
|
||
REDEMPTION
|
|
||
Section 3.1
|
Notice to Trustee.
|
16
|
|
Section 3.2
|
Selection of Securities to be Redeemed.
|
16
|
|
Section 3.3
|
Notice of Redemption.
|
16
|
|
Section 3.4
|
Effect of Notice of Redemption.
|
17
|
|
Section 3.5
|
Deposit of Redemption Price.
|
18
|
|
Section 3.6
|
Securities Redeemed in Part.
|
18
|
|
ARTICLE IV
|
|
||
COVENANTS
|
|
||
Section 4.1
|
Payment of Principal and Interest.
|
18
|
|
Section 4.2
|
SEC Reports.
|
19
|
|
Section 4.3
|
Compliance Certificate.
|
19
|
|
Section 4.4
|
Stay, Extension and Usury Laws.
|
19
|
|
Section 4.5
|
Corporate Existence.
|
20
|
|
ARTICLE V
|
|
||
SUCCESSORS
|
|
||
Section 5.1
|
When Company May Merge, Etc.
|
20
|
|
Section 5.2
|
Successor Corporation Substituted.
|
20
|
|
ARTICLE VI
|
|
||
DEFAULTS AND REMEDIES
|
|||
Section 6.1
|
Events of Default.
|
21
|
|
Section 6.2
|
Acceleration of Maturity; Rescission and Annulment.
|
22
|
|
Section 6.3
|
Collection of Indebtedness and Suits for Enforcement by Trustee.
|
23
|
|
Section 6.4
|
Trustee May File Proofs of Claim.
|
23
|
|
Section 6.5
|
Trustee May Enforce Claims Without Possession of Securities.
|
24
|
|
Section 6.6
|
Application of Money Collected.
|
24
|
|
Section 6.7
|
Limitation on Suits.
|
25
|
|
Section 6.8
|
Unconditional Right of Holders to Receive Principal and Interest.
|
25
|
|
Section 6.9
|
Restoration of Rights and Remedies.
|
26
|
|
Section 6.10
|
Rights and Remedies Cumulative.
|
26
|
|
Section 6.11
|
Delay or Omission Not Waiver.
|
26
|
|
Section 6.12
|
Control by Holders.
|
26
|
|
Section 6.13
|
Waiver of Past Defaults.
|
27
|
|
Section 6.14
|
Undertaking for Costs.
|
27
|
|
ARTICLE VII
|
|
||
TRUSTEE
|
|
||
Section 7.1
|
Duties of Trustee.
|
27
|
|
Section 7.2
|
Rights of Trustee.
|
29
|
|
Section 7.3
|
Individual Rights of Trustee.
|
30
|
|
Section 7.4
|
Trustee’s Disclaimer.
|
30
|
|
Section 7.5
|
Notice of Defaults.
|
30
|
|
Section 7.6
|
Reports by Trustee to Holders.
|
31
|
|
Section 7.7
|
Compensation and Indemnity.
|
31
|
|
Section 7.8
|
Replacement of Trustee.
|
32
|
|
Section 7.9
|
Successor Trustee by Merger, Etc.
|
33
|
|
Section 7.10
|
Eligibility; Disqualification.
|
33
|
|
Section 7.11
|
Preferential Collection of Claims Against Company.
|
33
|
|
ARTICLE VIII
|
|
||
SATISFACTION AND DISCHARGE; DEFEASANCE
|
|||
Section 8.1
|
Satisfaction and Discharge of Indenture.
|
33
|
|
Section 8.2
|
Application of Trust Funds; Indemnification.
|
34
|
|
Section 8.3
|
Legal Defeasance of Securities of any Series.
|
35
|
|
Section 8.4
|
Covenant Defeasance.
|
36
|
|
Section 8.5
|
Repayment to Company.
|
37
|
|
Section 8.6
|
Reinstatement.
|
38
|
|
ARTICLE IX
|
|
||
AMENDMENTS AND WAIVERS
|
|||
Section 9.1
|
Without Consent of Holders.
|
38
|
|
Section 9.2
|
With Consent of Holders.
|
39
|
|
Section 9.3
|
Limitations.
|
39
|
|
Section 9.4
|
Compliance with Trust Indenture Act.
|
40
|
|
Section 9.5
|
Revocation and Effect of Consents.
|
40
|
|
Section 9.6
|
Notation on or Exchange of Securities.
|
41
|
|
Section 9.7
|
Trustee Protected.
|
41
|
|
ARTICLE X
|
|
||
MISCELLANEOUS
|
|
||
Section 10.1
|
Trust Indenture Act Controls.
|
41
|
|
Section 10.2
|
Notices.
|
41
|
|
Section 10.3
|
Communication by Holders with Other Holders.
|
42
|
|
Section 10.4
|
Certificate and Opinion as to Conditions Precedent.
|
43
|
|
Section 10.5
|
Statements Required in Certificate or Opinion.
|
43
|
|
Section 10.6
|
Rules by Trustee and Agents.
|
43
|
|
Section 10.7
|
Legal Holidays.
|
43
|
|
Section 10.8
|
No Recourse Against Others.
|
44
|
|
Section 10.9
|
Counterparts.
|
44
|
|
Section 10.10
|
Governing Law; Jury Trial Waiver.
|
44
|
|
Section 10.11
|
No Adverse Interpretation of Other Agreements.
|
44
|
|
Section 10.12
|
Successors.
|
44
|
|
Section 10.13
|
Severability.
|
44
|
|
Section 10.14
|
Table of Contents, Headings, Etc.
|
45
|
|
Section 10.15
|
Securities in a Foreign Currency.
|
45
|
|
Section 10.16
|
Judgment Currency.
|
45
|
|
Section 10.17
|
Force Majeure.
|
46
|
|
Section 10.18
|
U.S.A. Patriot Act.
|
46
|
|
ARTICLE XI
|
|
||
SINKING FUNDS
|
|
||
Section 11.1
|
Applicability of Article.
|
46
|
|
Section 11.2
|
Satisfaction of Sinking Fund Payments with Securities.
|
47
|
|
Section 11.3
|
Redemption of Securities for Sinking Fund.
|
47
|
|
§ 310(a)(1)
|
7.10
|
(a)(2)
|
7.10
|
(a)(3)
|
Not Applicable
|
(a)(4)
|
Not Applicable
|
(a)(5)
|
7.10
|
(b)
|
7.10
|
§ 311(a)
|
7.11
|
(b)
|
7.11
|
(c)
|
Not Applicable
|
§ 312(a)
|
2.6
|
(b)
|
10.3
|
(c)
|
10.3
|
§ 313(a)
|
7.6
|
(b)(1)
|
7.6
|
(b)(2)
|
7.6
|
(c)(1)
|
7.6
|
(d)
|
7.6
|
§ 314(a)
|
4.2, 10.5
|
(b)
|
Not Applicable
|
(c)(1)
|
10.4
|
(c)(2)
|
10.4
|
(c)(3)
|
Not Applicable
|
(d)
|
Not Applicable
|
(e)
|
10.5
|
(f)
|
Not Applicable
|
§ 315(a)
|
7.1
|
(b)
|
7.5
|
(c)
|
7.1
|
(d)
|
7.1
|
(e)
|
6.14
|
§ 316(a)
|
2.10
|
(a)(1)(A)
|
6.12
|
(a)(1)(B)
|
6.13
|
(b)
|
6.8
|
§ 317(a)(1)
|
6.3
|
(a)(2)
|
6.4
|
(b)
|
2.5
|
§ 318(a)
|
10.1
|
TERM
|
DEFINED IN
SECTION |
“
Bankruptcy Law
”
|
6.1
|
“
Custodian
”
|
6.1
|
“
Event of Default
”
|
6.1
|
“
Judgment Currency
”
|
10.16
|
“
Legal Holiday
”
|
10.7
|
“
mandatory sinking fund payment
”
|
11.1
|
“
Market Exchange Rate
”
|
10.15
|
“
New York Banking Day
”
|
10.16
|
“
Notice Agent
”
|
2.4
|
“
optional sinking fund payment
”
|
11.1
|
“
Paying Agent
”
|
2.4
|
“
Registrar
”
|
2.4
|
“
Required Currency
”
|
10.16
|
“
successor person
”
|
5.1
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY, LTD.
|
|
By:
|
|
|
Name:
|
|
Its:
|
|
|
[ ]
|
|
|
|
By:
|
|
|
Name:
|
|
Its:
|
1
|
Documents Reviewed
|
1.1
|
The public records of the Company on file and available for public inspection at the Registry of Corporate Affairs in the British Virgin Islands (the "
Registry of Corporate Affairs
") on 17 June 2019, including the Company's Certificate of Incorporation and its Memorandum and Articles of Association (the "
Memorandum and Articles
").
|
1.2
|
The records of proceedings available from a search of the electronic records maintained on the Judicial Enforcement Management System from 1 January 2000 and available for inspection on 17 June 2019 at the British Virgin Islands High Court Registry (the "
High Court Registry
").
|
1.3
|
The unanimous written resolutions of the board of directors of the Company dated 7 June 2019 and a secretary's certificate dated 17 June 2019 appending, as certified true and complete copies, minutes of the meeting of the board of directors of the Company held on 12 June 2019 (the "
Resolutions
").
|
1.4
|
A Certificate of Incumbency dated 17 June 2019, issued by Maples Corporate Services (BVI) Limited, the Company's registered agent (the "
Registered Agent's Certificate
").
|
1.5
|
A certificate from a director of the Company (the "
Director's Certificate
").
|
1.6
|
The Registration Statement.
|
2
|
Assumptions
|
2.1
|
The authorisation, creation, issuance or exercise of the Securities (other than the Common Shares) or the entry into any agreement or arrangement in respect of the Securities (other than the Common Shares) or execution or performance of the same does not and will not require the consent of the holders of the series A preferred shares in the Company (the "
Series A Preferred Shareholders
") in accordance with the terms of the Memorandum and Articles or any other arrangement or agreement between the Series A Preferred Shareholders and the Company.
|
2.2
|
The creation and issuance of the Preferred Shares has been, or will be, authorised and approved by the directors of the Company and, prior to the issuance of any such Preferred Shares, an appropriate amendment to, or restatement of the Memorandum and Articles to create the Preferred Shares (including all rights attaching thereto) has been registered by the Registrar of Corporate Affairs in the British Virgin Islands, for the avoidance of doubt, any such amendment to the Memorandum and Articles shall not affect the opinions set out below (the "
Amended Memorandum and Articles
").
|
2.3
|
The indenture to be entered into by the Company and any trustee pursuant to which the Debt Securities will be issued (the "
Indenture
"), the Debt Securities, the deposit agreements to be entered into between the Company and the financial institutions designated as depositaries thereunder pursuant to which the Depositary Shares will be issued (the "
Deposit Agreements
"), the Depositary Shares, the Warrants, the warrant agreements to be entered into between the Company and the financial institutions designated as warrant agent thereunder pursuant to which the Warrants will be issued (the “
Warrant Agreements
”), the Rights, the rights agreements to be entered into by the Company and the financial institutions designated as rights agent thereunder pursuant to which the Rights will be issued (the “
Rights Agreements
”),
the Purchase Contracts, the Units and the unit agreements to be entered into by the Company pursuant to which the Units will be issued (the “
Unit Agreements
”, together with the Indenture,
|
2.4
|
The Securities (other than the Shares) and the Agreements are, or will be, legal, valid, binding and enforceable against all relevant parties in accordance with their terms under the laws of the State of New York and all other relevant laws.
|
2.5
|
The choice of the laws of the State of New York as the governing law of the Securities (other than the Shares) and the Agreements has, or will have, been made in good faith and would be regarded as a valid and binding selection which will be upheld by the courts of the State of New York and any other relevant jurisdiction (other than the laws of the British Virgin Islands) as a matter of the laws of the State of New York and all other relevant laws (other than the laws of the British Virgin Islands)
|
2.6
|
The capacity, power, authority and legal right of all parties under all relevant laws and regulations (other than, with respect to the Company, the laws of the British Virgin Islands) to enter into, execute, unconditionally deliver and perform their respective obligations under the Securities (other than the Shares) and the Agreements.
|
2.7
|
Any Securities (other than the Shares) will be issued and authenticated in accordance with the provisions of all relevant duly authorised, executed and delivered Agreement.
|
2.8
|
The Securities (other than the Shares) and the Agreements will be, or have been, duly executed and delivered by an authorised person of the parties thereto.
|
2.9
|
There is no contractual or other prohibition or restriction (other than as arising under British Virgin Islands law) binding on the Company prohibiting or restricting it from entering into and performing its obligations under Securities (other than the Shares) and the Agreements.
|
2.10
|
The issue of the Securities and entry into the Agreements will be of commercial benefit to the Company.
|
2.11
|
Copies of documents, conformed copies or drafts of documents provided to us are true and complete copies of, or in the final forms of, the originals.
|
2.12
|
All signatures, initials and seals are genuine.
|
2.13
|
That all public records of the Company which we have examined are accurate and that the information disclosed by the searches which we conducted against the Company at the Registry of Corporate Affairs and the High Court Registry is true and complete and that such information has not since then been altered and that such searches did not fail to disclose any information which had been delivered for registration but did not appear on the public records at the date of our searches.
|
2.14
|
The Memorandum and Articles remain in full force and effect and are unamended other than in the case of Preferred Shares being issued under the Amended Memorandum and Articles. There will be sufficient Shares authorised for issue under the Memorandum and Articles or Amended Memorandum and Articles, as appropriate.
|
2.15
|
The Resolutions passed at any meeting of the board of directors of the Company are a true and correct record of the proceedings of a meeting of the board of directors of the Company, which was duly convened and held, and at which a quorum was present throughout and at which each director disclosed his interest (if any), in the manner prescribed in the Memorandum and Articles, and the resolutions passed at such meeting have not been amended, varied or revoked in any respect. The written resolutions of the board of directors dated 12 June 2019 were signed by all the directors in the manner prescribed in the Memorandum and Articles of the Company, including as to the disclosure of any director's interests, and have not been amended, varied or revoked in any respect.
|
2.16
|
The members of the Company (the "
Members
") have not restricted or limited the powers of the directors of the Company in any way.
|
2.17
|
No invitation has been or will be made by or on behalf of the Company to the public in the British Virgin Islands to subscribe for any of the Shares.
|
2.18
|
The Company will receive money or money's worth in consideration for the issue of the Shares, and none of the Shares were or will be issued for less than par value.
|
2.19
|
There is nothing under any law (other than the laws of the British Virgin Islands) which would or might affect the opinions set out below.
|
3
|
Opinions
|
3.1
|
The Company is a company limited by shares duly incorporated with limited liability under the BVI Business Companies Act (as amended), is in good standing at the Registry of Corporate Affairs, is validly existing under the laws of the British Virgin Islands and possesses the capacity to sue and be sued in its own name
|
3.2
|
The issue of the Common Shares by the Company as contemplated by the Registration Statement has been authorised, and when issued and paid for in the manner described in the Registration Statement and in accordance with the Resolutions, such Common Shares will be legally issued, fully paid and non-assessable. As a matter of British Virgin Islands law, a share is only issued when it has been entered in the register of members of the Company.
|
3.3
|
The Company has all the requisite power and authority under the Memorandum and Articles to enter into, execute and perform its obligations under:
|
(a)
|
the Indenture to which it will be a party and the Debt Securities issuable under such Indenture to which it is, or will be, a party;
|
(b)
|
each Deposit Agreement to which it will be a party and the Depositary Shares issuable under each such Deposit Agreement to which it is, or will be, a party;
|
(c)
|
each Warrant Agreement to which it will be a party and the Warrants issuable under each such Warrant Agreement to which will be a party;
|
(d)
|
each Rights Agreement to which it will be a party and the Rights issuable under each such Rights Agreement to which will be a party;
|
(e)
|
each Purchase Contract to which it will be a party; and
|
(f)
|
each Unit Agreement to which it will be a party and the Units issuable under each such Unit Agreement to which will be a party.
|
3.4
|
With respect to the Preferred Shares, when (i) the board of directors of the Company has taken all necessary corporate action to approve the issue thereof, the terms of the offering thereof and related matters; (ii) the Amended Memorandum and Articles have been registered by the Registrar of Corporate Affairs in the British Virgin Islands, (iii) the issue of such Preferred Shares has been recorded in the Company's register of members, and (iv) the subscription price of such Preferred Shares (being not less than the par value of the Preferred Shares) has been fully paid in cash or other consideration approved by the board of directors of the Company, the Preferred Shares will be duly authorised, validly issued, fully paid and non-assessable.
|
3.5
|
With respect to each issue of Debt Securities pursuant to the Indenture, when (i) the board of directors of the Company has taken all necessary corporate action to approve the issue thereof, the terms of the offering thereof and related matters; (ii) the Indenture relating to the Debt Securities shall have been duly authorised and validly exected and delivered by the Company and the trustee thereunder; and (iii) when such Debt Securities issued thereunder have been duly executed and delivered on behalf of the Company and authenticated in the manner set forth in the Indenture relating to such issue of Debt Securities and delivered against due payment therefor pursuant to, and in accordance with, the terms of the Registration Statement and any relevant prospectus supplement, such Indenture and the Debt Securities issued pursuant to the Indenture will have been duly executed, issued and delivered.
|
3.6
|
With respect to the Deposit Agreements and the Depositary Shares, when (i) the board of directors of the Company has taken all necessary corporate action to approve the creation and terms of the Depositary Shares and to approve the issue thereof, the terms of the offering thereof and related matters; (ii) a Deposit Agreement relating to the Depositary Shares shall have been duly authorised and validly executed and delivered by the Company and the financial institution designated as depositary thereunder; and (iii) the certificates representing the Depositary Shares have been duly executed, countersigned, registered and delivered in accordance with the Deposit Agreement relating to the Depositary Shares and the applicable definitive purchase, underwriting or similar agreement approved by the board of directors of the Company upon payment of the consideration therefor provided therein, the Deposit Agreements and the Depositary Shares issued thereunder will be duly authorised, legal and binding obligations of the Company.
|
3.7
|
With respect to the Warrant Agreements and the Warrants, when (i) the board of directors of the Company has taken all necessary corporate action to approve the creation and terms of the Warrants and to approve the issue thereof, the terms of the offering thereof and related matters; (ii) a Warrant Agreement relating to the Warrants shall have been duly authorised and validly executed and delivered by the Company and the financial institution designated as warrant agent thereunder; and (iii) the certificates representing the Warrants have been duly executed, countersigned, registered and delivered in accordance with the Warrant Agreement relating to the Warrants and the applicable definitive purchase, underwriting or similar agreement approved by the board of directors of the Company upon payment of the consideration therefor
|
3.8
|
With respect to the Rights Agreements and the Rights, when (i) the board of directors of the Company has taken all necessary corporate action to approve the creation and terms of the Rights and to approve the issue thereof, the terms of the offering thereof and related matters; (ii) a Rights Agreement relating to the Rights shall have been duly authorised and validly executed and delivered by the Company and the financial institution designated as rights agent thereunder; and (iii) the certificates representing the Rights have been duly executed, countersigned, registered and delivered in accordance with the Rights Agreement relating to the Rights and the applicable definitive purchase, underwriting or similar agreement approved by the board of directors of the Company upon payment of the consideration therefor provided therein, the Rights Agreements and the Rights issued thereunder will be duly authorised, legal and binding obligations of the Company.
|
3.9
|
With respect to the Purchase Contracts, when a Purchase Contract shall have been duly authorised and validly executed and delivered by the Company and other parties thereto, such Purchase Contract will be duly authorised, legal and binding obligations of the Company. With respect to the Unit Agreements and the Units, when (i) the board of directors of the Company has taken all necessary corporate action to approve the creation and terms of the Units and to approve the issue thereof, the terms of the offering thereof and related matters; and (ii) a Unit Agreement relating to the Units shall have been duly authorised and validly executed and delivered by the Company and other parties thereto; and (iii) the certificates representing the Units have been duly executed, countersigned, registered and delivered in accordance with the Unit Agreement relating to the Units and the applicable definitive purchase, underwriting or similar agreement approved by the board of directors of the Company upon payment of the consideration therefor provided therein, the Unit Agreements and the Units issued thereunder will be duly authorised, legal and binding obligations of the Company.
|
3.10
|
With respect to the Unit Agreements and the Units, when (i) the board of directors of the Company has taken all necessary corporate action to approve the creation and terms of the Units and to approve the issue thereof, the terms of the offering thereof and related matters; (ii) a Unit Agreement relating to the Units shall have been duly authorised and validly executed and delivered by the Company and other parties thereto; and (iii) the certificates representing the Units have been duly executed, countersigned, registered and delivered in accordance with the Unit Agreement relating to the Units and the applicable definitive purchase, underwriting or similar agreement approved by the board of directors of the Company upon payment of the consideration therefor provided therein, the Unit Agreements and the Units issued thereunder will be duly authorised, legal and binding obligations of the Company.
|
4
|
Qualifications
|
4.1
|
We have not reviewed the Agreements or the terms of the Securities (other than the Common Shares) and our opinions are qualified accordingly.
|
4.2
|
The obligations assumed by the Company under the Agreements and the issuance of the Securities thereunder will not necessarily be enforceable in all circumstances in accordance with their terms. In particular:
|
(a)
|
enforcement may be limited by bankruptcy, insolvency, liquidation, reorganisation, readjustment of debts or moratorium or other laws of general application relating to or affecting the rights of creditors;
|
(b)
|
enforcement may be limited by general principles of equity. For example, equitable remedies such as specific performance may not be available, inter alia, where damages are considered to be an adequate remedy;
|
(c)
|
some claims may become barred under relevant statutes of limitation or may be or become subject to defences of set off, counterclaim, estoppel and similar defences;
|
(d)
|
where obligations are to be performed in a jurisdiction outside the British Virgin Islands, they may not be enforceable in the British Virgin Islands to the extent that performance would be illegal under the laws of that jurisdiction;
|
(e)
|
the courts of the British Virgin Islands have jurisdiction to give judgment in the currency of the relevant obligation;
|
(f)
|
arrangements that constitute penalties will not be enforceable;
|
(g)
|
enforcement may be prevented by reason of fraud, coercion, duress, undue influence, misrepresentation, public policy or mistake or limited by the doctrine of frustration of contracts;
|
(h)
|
an agreement made by a person in the course of carrying on unauthorised financial services business is unenforceable against the other party under section 50F of the Financial Services Commission Act, 2001;
|
(i)
|
provisions imposing confidentiality obligations may be overridden by compulsion of applicable law or the requirements of legal and/or regulatory process;
|
(j)
|
the courts of the British Virgin Islands may decline to exercise jurisdiction in relation to substantive proceedings brought under or in relation to the Agreements in matters where they determine that such proceedings may be tried in a more appropriate forum;
|
(k)
|
a person who is not a party to an Agreement that is governed by British Virgin Islands law will not have the benefit of and will not be able to enforce its terms;
|
(l)
|
any provision of an Agreement that is governed by British Virgin Islands law which expresses any matter to be determined by future agreement may be void or unenforceable;
|
(m)
|
we reserve our opinion as to the enforceability of the relevant provisions of an Agreement to the extent that it purports to grant exclusive jurisdiction as there may be circumstances in which the courts of the British Virgin Islands would accept jurisdiction notwithstanding such provisions; and
|
(n)
|
a company cannot, by agreement or in its articles of association, restrict the exercise of a statutory power and there is doubt as to the enforceability of any provision in the Agreements whereby the Company covenants to restrict the exercise of powers specifically given to it under the Act including, without limitation, the power to increase its maximum number of shares, amend its memorandum and articles of association or present a petition to a British Virgin Islands court for an order to wind up the Company
|
4.3
|
Applicable court fees will be payable in respect of enforcement of the Agreements.
|
4.4
|
To maintain the Company in good standing under the laws of the British Virgin Islands, annual filing fees must be paid to the Registry of Corporate Affairs.
|
4.5
|
Preferred creditors under British Virgin Islands law will rank ahead of unsecured creditors of the Company. Furthermore, all costs, charges and expenses properly incurred in the winding up of a company, including the remuneration of the liquidators, are payable out of the assets of the company in priority to all other unsecured claims.
|
4.6
|
The obligations of the Company may be subject to restrictions pursuant to United Nations sanctions as implemented under the laws of the British Virgin Islands and/or restrictive measures adopted by the European Union Council for Common Foreign and Security Policy extended to the British Virgin Islands by the Order of Her Majesty in Council
|
4.7
|
A certificate, determination, calculation or designation of any party to an Agreement as to any matter provided therein might be held by a British Virgin Islands court not to be conclusive final and binding if, for example, it could be shown to have an unreasonable or arbitrary basis, or in the event of manifest error
|
4.8
|
We reserve our opinion as to the extent to which the courts of the British Virgin Islands would, in the event of any relevant illegality or invalidity, sever the relevant provisions of an Agreement and enforce the remainder of the Agreement or the transaction of which such provisions form a part, notwithstanding any express provisions in an Agreement in this regard.
|
4.9
|
We express no opinion as to the meaning, validity or effect of any references to foreign (i.e. non-British Virgin Islands) statutes, rules, regulations, codes, judicial authority or any other promulgations and any references to them in an Agreement.
|
4.10
|
Under section 42 of the Act, the entry of the name of a person in the register of members of a company as a holder of a share in a company is prima facie
evidence that legal title in the share vests in that person. A third party interest in the shares in question would not appear. An entry in the register of members may yield to a court order for rectification (for example, in the event of inaccuracy or omission).
|
4.11
|
In this opinion, the phrase "non-assessable" means, with respect to the Shares in the Company, that a shareholder shall not, solely by virtue of its status as a shareholder, be liable for additional assessments or calls on the Shares by the Company or its creditors (except in exceptional circumstances, such as involving fraud, the establishment of an agency relationship or an illegal or improper purpose or other circumstance in which a court may be prepared to pierce or lift the corporate veil).
|
4.12
|
We express no view as to the commercial terms of the Securities or the Agreements or whether such terms represent the intentions of the parties and we make no comment with respect to any representations and warranties which may be made by or with respect to the Company in
|
Biohaven Pharmaceutical Holding Company Ltd.
|
-
2
-
|
Biohaven Pharmaceutical Holding Company Ltd.
|
-
3
-
|
Biohaven Pharmaceutical Holding Company Ltd.
|
-
4
-
|
Biohaven Pharmaceutical Holding Company Ltd.
|
-
5
-
|
1.
|
Capitalized terms not defined herein shall be defined as provided in the Original Agreement.
|
2.
|
Section 3.5 of the Original Agreement is deleted in its entirety.
|
3.
|
Section 4.2 of the Original Agreement is deleted in its entirety.
|
4.
|
Biohaven hereby assigns all of its rights and obligations under the Original Agreement to its wholly owned subsidiary, Therapeutics and Therapeutics accepts all of the rights and obligations of the Original Agreement that formally were the rights and obligations of Biohaven.
|
5.
|
ALS agrees to the assignment of the Original Agreement to Therapeutics, and further agrees that this assignment shall not be deemed an abandonment of the making, having made, using, selling, having sold, development, exploitation, licensing, researching, exporting or importing of all of the Patent Products as defined in the Original Agreement.
|
6.
|
The Parties agree that they are in compliance with all of the obligations under the Original Agreement as of the date of execution of this amendment, and that all of the Initial Payments under Section 5.1 and all of the Milestones under Section 5.2 have been satisfied, except milestones 5.2(a) and 5.2(b), which payments are not yet due. ALS agrees that Therapeutics may make the payments under Sections 5.2(a) and 5.2(b) when they are due.
|
7.
|
Biohaven is released from all further obligations under the Original Agreement.
|
8.
|
Except as modified and amended hereby, the Original Agreement shall remain in full force and effect and is in all other respects ratified and confirmed.
|
9.
|
This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument and governed by the laws of the State of Delaware.
|
BIOHAVEN THERAPEUTICS LTD.
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
|
|
|
By:
/s/ Donnie McGrath
|
By:
/s/ Donnie McGrath
|
Name: Donnie McGrath MD
|
Name: Donnie McGrath MD
|
Title:
Chief Corporate Strategy
|
Title:
Chief Corporate Strategy
|
FOX CHASE CHEMICAL DIVERSITY CENTER INC.
|
ALS BIOPHARMA LLC
|
|
|
By:
/s/ Allen B. Reitz
|
By:
/s/ Allen B. Reitz
|
Name: Allen B. Reitz
|
Name: Allen B. Reitz
|
Title:
CEO
|
Title:
Managing Member
|
1.
|
BACKGROUND
|
2
|
|
2.
|
DEFINITIONS
|
3
|
|
3.
|
LICENSE GRANT AND TERM
|
9
|
|
4.
|
DUE DILIGENCE
|
11
|
|
5.
|
MILESTONE PAYMENTS
|
13
|
|
6.
|
EARNED ROYALTIES; MINIMUM ROYALTY PAYMENTS
|
13
|
|
7.
|
SUBLICENSES
|
17
|
|
8.
|
CONFIDENTIALITY AND PUBLICITY
|
18
|
|
9.
|
REPORTS, RECORDS AND INSPECTIONS
|
19
|
|
10.
|
PATENT PROTECTION
|
20
|
|
11.
|
INFRINGEMENT AND LITIGATION
|
21
|
|
12.
|
USE OF YALE’S NAME
|
23
|
|
13.
|
TERMINATION; REVIVAL OF ORIGINAL AGREEMENT
|
23
|
|
14.
|
INDEMNIFICATION; INSURANCE; NO WARRANTIES
|
26
|
|
15.
|
NOTICES
|
28
|
|
16.
|
INVENTOR AGREEMENTS
|
28
|
|
17.
|
LAWS, FORUM AND REGULATIONS
|
28
|
|
18.
|
MISCELLANEOUS
|
29
|
|
SIGNATURE PAGE
|
31
|
|
|
Appendix A: LICENSED PATENTS
|
34
|
|
|
Appendix B: PLAN
|
38
|
|
|
Appendix C: PRODRUG PATENTS
|
45
|
|
|
EXHIBIT 4.3: Intellectual Property Reporting Example
|
54
|
|
|
Exhibit 6.6: Wire Transfer Instructions
|
55
|
|
|
Exhibit 9.1: Sample Report
|
56
|
|
|
APPENDIX D: ASSIGNMENT and ASSUMPTION AGREEMENT
|
59
|
|
1.1
|
In the course of research conducted under YALE auspices, Drs. Vladimir Coric, Gerard Sanacora, and John H. Krystal, in the Department of Psychiatry at YALE (the “INVENTORS”), have produced inventions described by the LICENSED PATENTS and also known as [***] (the “INVENTION”).
|
1.2
|
INVENTORS have assigned to YALE all of INVENTORS’ right, title and interest in and to the INVENTION and any resulting patents.
|
1.3
|
YALE wishes to have the INVENTION and any resulting patents commercialized to benefit the public good.
|
1.4
|
LICENSEE has represented to YALE that it shall act diligently to develop and commercialize the LICENSED PRODUCTS.
|
1.5
|
YALE and LICENSEE’s AFFILIATE, Biohaven Pharmaceutical Holding Company Ltd. (“BIOHAVEN”), have entered into a license agreement dated as of September 16, 2013, and amended as of April 1, 2017, under which YALE granted to BIOHAVEN certain rights and licenses under the LICENSED PATENTS to develop and commercialize the LICENSED PRODUCTS (the “ORIGINAL AGREEMENT).
|
1.6
|
BIOHAVEN and its AFFILIATES have conducted development activities with LICENSED PRODUCTS and are engaged in clinical trials with the LICENSED PRODUCTS.
|
1.7
|
BIOHAVEN and its AFFILIATES have also conducted development activities with certain prodrugs of riluzole (“PRODRUG PRODUCTS”) and are engaged in clinical trials with certain of the PRODRUG PRODUCTS.
|
1.8
|
Prior to the AMENDED EFFECTIVE DATE, BIOHAVEN owned or controlled patents and patent applications relating to the PRODRUG PRODUCTS and their use (“PRODRUG PATENTS”) and has assigned the PRODRUG PATENTS to LICENSEE.
|
1.9
|
BIOHAVEN and LICENSEE wish to have the PRODRUG PRODUCTS and PRODRUG PATENTS commercialized to benefit the public good.
|
1.10
|
Contemporaneously with the execution of this AMENDED AGREEMENT, BIOHAVEN has assigned the ORIGINAL AGREEMENT to LICENSEE effective as of the AMENDED EFFECTIVE DATE to Biohaven Therapeutics Ltd., a British Virgin Islands
|
1.11
|
Pursuant to the Article 18.7 of the ORIGINAL AGREEMENT, YALE hereby approves the contemporaneous assignment of the ORIGINAL AGREEMENT to ASSIGNEE pursuant to a fully executed ASSIGNMENT AGREEMENT. The fully executed Assignment and Assumption Agreement is attached and incorporated hereto as Appendix D (the “ASSIGNMENT AGREEMENT”).
|
1.12
|
LICENSEE and YALE desire to amend and restate the ORIGINAL AGREEMENT to enable LICENSE to develop and commercialize the LICENSED PRODUCTS, the PRODRUG PRODUCTS, or both.
|
1.13
|
YALE is willing to grant a license to LICENSEE, subject to the terms and conditions of this AMENDED AGREEMENT.
|
1.14
|
In consideration of these statements and mutual promises, YALE and LICENSEE agree to the terms of this AMENDED AGREEMENT.
|
2.1
|
“AFFILIATE” shall mean any entity or person that directly or indirectly controls, is controlled by or is under common control with LICENSEE. For purposes of this definition, “control” means possession of the power to direct the management of such entity or person, whether through ownership of more than fifty percent (50%) of voting securities, by contract or otherwise.
|
2.2
|
“AMENDED EFFECTIVE DATE” is defined in the introductory paragraph of this AMENDED AGREEMENT.
|
2.3
|
“ASSIGNEE” is defined in Article 1.10.
|
2.4
|
“ASSIGNMENT AGREEMENT” is defined in Article 1.10.
|
2.5
|
“CLINICAL TRIAL” shall mean either a PHASE I CLINICAL TRIAL, PHASE II CLINICAL TRIAL, PHASE III CLINICAL TRIAL, or a PIVOTAL TRIAL
|
2.6
|
“COMBINATION PRODUCT” shall mean a single pharmaceutical formulation containing as its active ingredients riluzole, or a PRODRUG PRODUCT, and one or more other therapeutically or prophylactically active ingredients, or a combination therapy comprised of riluzole, or a PRODRUG PRODUCT, and one or more other therapeutically or prophylactically active products, priced and sold in a single package containing such multiple products or packaged separately but sold together for a single price and in each case, including all dosage forms, formulations, presentations, line extensions, and package configurations.
|
2.7
|
“CONFIDENTIAL INFORMATION” shall mean all information disclosed by one party to the other during the negotiation of or under the ORIGINAL AGREEMENT or this AMENDED AGREEMENT in any manner, whether orally, visually or in tangible form, that relates to LICENSED PATENTS, PRODRUG PATENTS or the AMENDED AGREEMENT itself, unless such information is subject to an exception described in Article 8.2;
provided
,
however
, that CONFIDENTIAL INFORMATION that is disclosed in tangible form shall be marked “Confidential” at the time of disclosure and CONFIDENTIAL INFORMATION that is disclosed orally or visually shall be identified as confidential at the time of disclosure and subsequently reduced to writing, marked confidential and delivered to the other party within thirty (30) days of such disclosure. CONFIDENTIAL INFORMATION shall include, without limitation, materials, know- how and data, technical or non-technical, trade secrets, inventions, methods and processes, whether or not patentable. Notwithstanding any other provisions of this Article 2.5, CONFIDENTIAL INFORMATION of LICENSEE that is subject to Article 8 of this AMENDED AGREEMENT is limited to information that LICENSEE supplies pursuant to LICENSEE’s obligations under Articles 7 and 9 of this AMENDED AGREEMENT, or has supplied pursuant to LICENSEE’s obligations under Articles 7 and 9 of the ORIGINAL AGREEMENT, unless otherwise mutually agreed to in writing by the parties.
|
2.8
|
“DEVELOPING ECONOMIES” shall mean those countries that are designated by The World Bank or its successor organization as having economies that are low- and middle- income economies (excluding The People’s Republic of China and India, which shall not be considered countries with developing economies).
|
2.9
|
“EARNED ROYALTY” is defined in Article 6.1.
|
2.10
|
“EFFECTIVE DATE” shall mean the effective date of the ORIGINAL AGREEMENT which is September 16, 2013.
|
2.11
|
Intentionally Omitted.
|
2.12
|
“FDA” shall mean the U.S. Food and Drug Administration to obtain marketing approval for a LICENSED PRODUCT in the United States, or any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States.
|
2.13
|
“FIELD” shall mean any use in humans.
|
2.14
|
“FIRST SALE” shall mean the first sale, lease or other transfer, practice or disposition to a THIRD PARTY of any LICENSED PRODUCT or PRODRUG PRODUCT in any country.
|
2.15
|
“GENERIC(S)” shall mean shall mean THIRD PARTY products sold in the FIELD, but not products sold by LICENSEE, AFFILIATES, or SUBLICENSEE, that was previously exclusive due to a VALID CLAIM of a LICENSED PATENT or a PRODRUG PATENT
|
2.16
|
“IND” shall mean an investigational new drug application filed with the United States Food and Drug Administration prior to beginning clinical trials in humans in the United States or any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States.
|
2.17
|
“INITIATE” or “INITIATION” or “INITIATES” or any variant thereof shall mean, with respect to a CLINICAL TRIAL, the first dose of a LICENSED PRODUCT administered to a human subject by or on behalf of LICENSEE, SUBLICENSEE, or AFFILIATE.
|
2.18
|
“INVENTION” and “INVENTORS” are defined in Article 1.1.
|
2.19
|
“INVENTOR AGREEMENT” shall mean a consulting or other agreement directly between LICENSEE and an INVENTOR.
|
2.20
|
“INSOLVENT” shall mean that LICENSEE (i) as defined by the United States Federal Bankruptcy Law, as amended from time to time, or (ii) has commenced bankruptcy, reorganization, receivership or insolvency proceedings, or any other proceeding under any Federal, state or other law for the relief of debtors.
|
2.21
|
“LICENSE” refers to the license granted under Article 3.1.
|
2.22
|
“LICENSED METHOD” shall mean any method, procedure, service or process the practice of which is claimed by a VALID CLAIM of a LICENSED PATENT, or which uses a LICENSED PRODUCT of the type defined in subsection (a) of the definition of LICENSED PRODUCT.
|
2.23
|
“LICENSED PATENTS” shall mean the United States or foreign patent application(s) and patents(s) listed in Appendix A and owned by YALE during the TERM, together with any continuations, divisionals, and continuations-in-part, to the extent the claims of any such patent or patent application are directed to subject matter specifically described in the patent applications listed on Appendix A; any reissues, re-examinations, or extensions thereof, or substitutes therefor; and the relevant international equivalents of any of the foregoing. Appendix A is incorporated into this AMENDED AGREEMENT.
|
2.24
|
“LICENSED PRODUCT” shall mean
|
(a)
|
any product (including any apparatus or kit) or component part thereof, if the manufacture, use, sale, import, export or practice thereof is claimed by a VALID CLAIM of a LICENSED PATENT.
|
(b)
|
any LICENSED METHOD.
|
2.25
|
“LICENSED TERRITORY” shall mean worldwide.
|
2.26
|
“MARKETING APPROVAL” shall mean shall mean the receipt by LICENSEE, SUBLICENSEE, or AFFILIATE of an official notification or other comparable communication from the FDA (if in the United States), or any comparable notification from the relevant regulatory authority for a country or group of countries other than the United States, that allows the commercial marketing (including any pricing or reimbursement approval, should it be required for the marketing) of a LICENSED PRODUCT or a PRODRUG PRODUCT.
|
2.27
|
“MARKET SHARE” is defined in Article 6.8.
|
2.28
|
“MP” is defined in Article 6.7.
|
2.29
|
“NDA” shall mean New Drug Application filed with the FDA.
|
2.30
|
“NET SALES” shall mean:
|
(a)
|
gross invoice price from the sale, lease or other transfer, practice or disposition of the LICENSED PRODUCTS or PRODRUG PRODUCTS, or from services performed using or constituting LICENSED PRODUCTS or PRODRUG PRODUCTS by LICENSEE, SUBLICENSEES or AFFILIATES to THIRD PARTIES, except as set forth in section (b) of this definition, less the following deductions, provided they actually pertain to the disposition of the LICENSED PRODUCTS or PRODRUG PRODUCTS and are separately invoiced:
|
i.
|
[***];
|
ii.
|
[***];
|
iii.
|
[***]; and
|
iv.
|
[***].
|
(b)
|
“NET SALES” shall not include the gross invoice price [***].
|
(c)
|
There shall be no deductions, except as specified in this definition, made to NET SALES for the purpose of calculating EARNED ROYALTIES owed to YALE as a result of royalties or other payments made to THIRD PARTIES.
|
(d)
|
[***].
|
2.31
|
“PATENT CHALLENGE” shall mean a challenge or opposition to the validity, patentability, enforceability and/or non-infringement of any of the LICENSED PATENTS or otherwise opposing any of the LICENSED PATENTS.
|
2.32
|
“PHASE I CLINICAL TRIAL” shall mean a human clinical trial constituting the initial introduction of an investigational new drug into humans, as defined in 21 C.F.R §312.21(a) and as practiced according to the standards of the pharmaceutical industry.
|
2.33
|
“PHASE II CLINICAL TRIAL” shall mean a human clinical trial conducted to evaluate the effectiveness of a drug for a particular indication in patients with a disease and to determine the common short-term side effects and risks associated with the drug as defined in 21 C.F.R §312.21(b) and as practiced according to the standards of the pharmaceutical industry.
|
2.34
|
“PHASE III CLINICAL TRIAL” shall mean expanded controlled and uncontrolled human clinical trials performed after PHASE II CLINICAL TRIAL(S) evidence suggesting effectiveness of an investigational new drug, as defined by 21 C.F.R §312.21(c), and as practiced according to the standards of the pharmaceutical industry for a Phase III clinical trial and prior to the filing of an NDA or comparable request for marketing approval.
|
2.35
|
“PIVOTAL TRIAL” shall mean a controlled human clinical trial to evaluate the safety and efficacy of a LICENSED PRODUCT or PRODRUG PRODUCT in which data are sufficient to form the basis for the filing of an NDA. A PIVOTAL TRIAL may not necessarily be a PHASE III CLINICAL TRIAL.
|
2.36
|
“PRECLINICAL” shall mean prior to the INITIATION of a first CLINICAL TRIAL by or on behalf of a LICENSEE, SUBLICENSEE, or AFFILIATE.
|
2.37
|
“PRODRUG FEE” is defined in Article 6.2.
|
2.38
|
“PRODRUG PATENTS” shall mean: (i) the United States or foreign patent application(s) and patents(s) listed in Appendix C and owned by LICENSEE during the TERM, together with any continuations, divisionals, and continuations-in-part, to the extent the claims of any such patent or patent application are directed to subject matter specifically described in the patent applications listed on Appendix C; (ii) any United States or foreign patent application(s) and patents(s) filed by LICENSEE and owned by LICENSEE during the TERM, together with any continuations, divisionals, and
|
2.39
|
“PUBLICLY TRADED COMPANY” shall mean an entity whose principal class of shares is listed on at least one recognized stock exchange or over the counter, provided its listed shares can be readily purchased or sold by the public. Shares can be purchased or sold “by the public” if the purchase or sale of such shares is not implicitly or explicitly restricted to a limited group of investors.
|
2.40
|
“QUALIFIED SUBLICENSEE” and “QUALIFIED ASSIGNEE” shall mean a pharmaceutical or biopharmaceutical that is a top [***] global company based upon annual sales of pharmaceutical or biopharmaceutical products.
|
2.41
|
“REASONABLE COMMERCIAL EFFORTS” shall mean documented efforts that are consistent with those utilized by companies of similar size and type that have successfully developed products and services similar to LICENSED PRODUCTS or PRODRUG PRODUCTS.
|
2.42
|
“SUBLICENSE” shall mean an agreement with a SUBLICENSEE by LICENSEE or an AFFILIATE conferring any of the rights granted to LICENSEE herein, including but not limited to an option, sublicense, cross-license, revenue-sharing agreement, discovery partnership, co-development partnership, or license, privilege, or immunity to make, have made, use, sell, have sold, distribute, practice, import or export LICENSED PRODUCTS or PRODRUG PRODUCTS.
|
2.43
|
“SUBLICENSEE” shall mean any THIRD PARTY with whom LICENSEE or an AFFILIATE has executed a SUBLICENSE.
|
2.44
|
“SUBLICENSE INCOME” shall mean consideration in any form received by LICENSEE or an AFFILIATE in connection with a SUBLICENSE. SUBLICENSE INCOME shall include, but not be limited to:
|
(a)
|
any consideration in any form, including without limitation, any license signing fee, license maintenance fee, option fee or other payment pursuant to an option, unearned portion of any minimum royalty payment received by LICENSEE, equity, distribution or joint marketing fee; and
|
(b)
|
research and development funding for work to be performed by LICENSEE either directly or by subcontractors after the effective date of a SUBLICENSE that is in excess of LICENSEE’s cost of performing such future work; and
|
(c)
|
any consideration received for an equity interest in LICENSEE to the extent such consideration exceeds the monetary value of private equity as determined by an independent appraiser mutually agreeable to the parties or, in the event that
|
(d)
|
shall also include any sale or extension of credit to LICENSEE for less than its monetary value, as determined by an independent appraiser. In the event an extension of credit or loan to LICENSEE by a SUBLICENSEE is forgiven in whole or in part by the SUBLICENSEE, such amount shall constitute SUBLICENSE INCOME;
|
(e)
|
SUBLICENSE INCOME shall not include the earned royalty consideration paid by a SUBLICENSEE to LICENSEE or an AFFILIATE for NET SALES of a LICENSED PRODUCT or a PRODRUG PRODUCT.
|
2.45
|
“TERM” is defined in Article 3.4.
|
2.46
|
“THIRD PARTY” or “THIRD PARTIES” shall mean any party other than LICENSEE and YALE or their AFFILIATES.
|
2.47
|
“VALID CLAIM” shall mean a pending, issued or unexpired claim of a LICENSED PATENT or a PRODRUG PATENT that has not been pending more than (i) [***] years from the AMENDED EFFECTIVE DATE or (ii) [***] years from the date of filing of an application claiming priority to the earliest priority application, so long as such claim shall not have been irrevocably abandoned or declared to be invalid in an unappealable decision of a court or other authority or competent jurisdiction through no fault or cause of LICENSEE;
provided
,
however
, that if a pending claim results in an issued patent after the periods indicated in (i) and/or (ii) in this Article 2.42, it shall thereafter again be a VALID CLAIM.
|
3.1
|
Subject to all the terms and conditions of this AMENDED AGREEMENT including the payment to YALE of the consideration described in Article 5, YALE grants to LICENSEE as of the EFFECTIVE DATE;
|
(a)
|
an exclusive license, subject to the reservation of rights by YALE under Article 3.3, under the LICENSED PATENTS to make, have made, use, sell, have sold, import, export, or practice LICENSED PRODUCTS within the FIELD in the LICENSED TERRITORY; and
|
(b)
|
The right to SUBLICENSE the rights granted under Article 3.1(a);
|
(c)
|
together, the rights granted under Article 3.1 (a), and (b) shall be the license granted hereunder (the “LICENSE”).
|
3.2
|
To the extent that any invention included within the LICENSED PATENTS has been funded in whole or in part by the United States government, the United States government retains certain rights in such invention as set forth in 35 U.S.C. §200-212 and all regulations promulgated thereunder, as amended, and any successor statutes and regulations (the “Federal Patent Policy”). As a condition of the license granted hereby, LICENSEE acknowledges and shall comply with all aspects of the Federal Patent Policy applicable to the LICENSED PATENTS, including the obligation that LICENSED PRODUCTS used or sold in the United States be manufactured substantially in the United States. Nothing contained in this AMENDED AGREEMENT obligates or shall obligate YALE to take any action that would conflict in any respect with its past, current or future obligations to the United States Government under the Federal Patent Policy with respect to the LICENSED PATENTS.
|
3.3
|
The LICENSE is expressly made subject to YALE’s reservation of the right, on behalf of itself and all other non-profit academic and/or research institutions, to make, use and practice the LICENSED PATENTS and LICENSED PRODUCTS for research, clinical research by YALE and its
bone fide
research partners, teaching or other non-commercial purposes, and not for purposes of commercial development, use, manufacture or distribution.
|
3.4
|
Unless terminated earlier as provided in Article 13, the term of this AMENDED AGREEMENT (the “TERM”) shall commence on the AMENDMENT EFFECTIVE DATE and shall expire on the later of (i) on a country-by-country basis, on the date on which the last of the VALID CLAIMS of the patents described in the LICENSED PATENTS in such country expires, lapses or is declared to be invalid by a non- appealable decision of a court or other authority of competent jurisdiction through no fault or cause of LICENSEE; (ii) on a country-by-country basis, on the date on which the last of the VALID CLAIMS of the patents described in the PRODRUG PATENTS in such country expires, lapses or is declared to be invalid by a non-appealable decision of a court or other authority of competent jurisdiction through no fault or cause of LICENSEE or YALE, or (iii) ten (10) years from the date of FIRST SALE.
|
3.5
|
Nothing in this AMENDED AGREEMENT shall be construed to grant by implication, estoppel or otherwise any licenses under patents of YALE other than the LICENSED PATENTS. Except as expressly provided in this AMENDED AGREEMENT, under no circumstances will LICENSEE, as a result of this AMENDED AGREEMENT, obtain any interest in or any other right to any technology, know-how, patents, patent applications, materials or other intellectual or proprietary property of YALE. Nothing in this AMENDED AGREEMENT shall be construed to grant to YALE by implication, estoppel or otherwise any licenses under any patents of LICENSEE, including without limitation the PRODRUG PATENTS.
|
4.1
|
LICENSEE has designed a plan for developing and commercializing the LICENSED PATENTS that includes a description of research and development, testing, government approval, manufacturing, marketing and sale or lease of LICENSED PRODUCTS (“PLAN”). A copy of the PLAN as of the EFFECTIVE DATE is attached to this AMENDED AGREEMENT as Appendix B and incorporated herein by reference. During the TERM, LICENSEE shall periodically revise and update the PLAN to describe the research and development, testing, government approval, manufacturing, marketing and sale or lease of LICENSED PRODUCTS and PRODRUG PRODUCTS.
|
4.2
|
LICENSEE shall use all REASONABLE COMMERCIAL EFFORTS at its sole expense to diligently commercialize the LICENSED PRODUCTS and PRODRUG PRODUCTS in the LICENSED TERRITORY;
provided
,
however
, that LICENSEE shall have the sole discretion to determine whether to commercialize either LICENSED PRODUCTS, PRODRUG PRODUCTS, or both, and which countries in the LICENSED TERRITORY to commercialize LICENSED PRODUCTS and PRODRUG PRODUCTS, provided that the countries for commercialization shall include at least the U.S., United Kingdom, France, Germany and Japan.
|
4.3
|
Annually after the AMENDED EFFECTIVE DATE, and within sixty (60) days after each anniversary of the AMENDED EFFECTIVE DATE, LICENSEE shall provide YALE with an updated and revised copy of the PLAN which shall:
|
(a)
|
indicate LICENSEE’s progress and problems to date in development and commercialization of LICENSED PRODUCTS and PRODRUG PRODUCTS;
|
(b)
|
include a forecast and schedule of major events required to market the LICENSED PRODUCTS and PRODRUG PRODUCTS; and
|
(c)
|
include a statement clearly indicating which of LICENSEE’s products or services are a LICENSED PRODUCT and which LICENSED PATENTS claim each such LICENSED PRODUCT utilized (e.g., see Exhibit 4.3).
|
4.4
|
Within [***] days after assignment by LICENSEE pursuant to Article 18.7, the assignee shall provide YALE with an updated and revised copy of the PLAN. Each updated and revised PLAN shall be substituted into this AMENDED AGREEMENT as Appendix B.
|
4.5
|
LICENSEE shall immediately, or as soon as reasonably possible, send YALE a notice of abandonment if at any time LICENSEE permanently discontinues its research, development or commercialization of both the LICENSED PRODUCTS and PRODRUG PRODUCTS, or its intent to research, develop and market both the LICENSED PRODUCTS and PRODRUG PRODUCTS. Such notices shall be deemed by YALE to be a breach that is incapable of being cured and YALE may, at its sole discretion, terminate this AMENDED AGREEMENT by written notice at any time after such notice of abandonment.
|
4.6
|
LICENSEE agrees that YALE shall be entitled to terminate this AMENDED AGREEMENT pursuant to Article 13.1(b) upon the occurrence of any of the following in the event that LICENSEE fails to cure in a timely manner as provided in ARTICLE 13:
|
(a)
|
LICENSEE shall fail to provide the written reports as provided in Article 4.3; or
|
(b)
|
LICENSEE shall fail to use REASONABLE COMMERCIAL EFFORTS to commercialize at least one of the LICENSED PRODUCTS or the PRODRUG PRODUCTS, provided that such termination right shall exist on a country-by- country basis within the LICENSED TERRITORY for any countries where LICENSEE has failed to use REASONABLE COMMERCIAL EFFORTS; or
|
(c)
|
LICENSEE gives notice pursuant to Article 4.5 (which shall be deemed a material breach not capable of being cured); or
|
(d)
|
LICENSEE has either (x) failed to INITIATE a PHASE III CLINICAL TRIAL or (y) failed to designate a CLINICAL TRIAL as a PIVOTAL TRIAL and, having designated such a CLINICAL TRIAL as a PIVOTAL TRIAL, then failed to file an NDA within [***] of the EFFECTIVE DATE for either a LICENSED PRODUCT or a PRODRUG PRODUCT;
provided
,
however
,
|
i.
|
that LICENSEE may elect to extend the diligence milestone in this Article 4.6(d) by a total of [***] upon payment to YALE of [***] if such an extension is for a PHASE III CLINICAL TRIAL; and such extension shall be a “DILIGENCE EXTENSION.”
|
ii.
|
LICENSEE may elect no more than [***] DILIGENCE [***] under this Article 4.6(e);
and provided further
|
iii.
|
that the DILIGENCE EXTENSION must be requested at least ninety (90) days prior to the date of the diligence obligation under this Article 4.6(e) for which a DILIGENCE EXTENSION is being requested by LICENSEE. The DILIGENCE [***] shall take effect only if payment is made to YALE by the date of the diligence obligation for which a DILIGENCE [***] has been requested.
|
4.7
|
During the TERM of this AMENDED AGREEMENT, for the duration of any period(s) of time exceeding ninety (90) days that LICENSEE, or a parent company AFFILIATE of LICENSEE, is not a PUBLICLY TRADED COMPANY, LICENSEE hereby grants YALE observer rights for one (1) person at all of LICENSEE’s Board of Director meetings. YALE shall be permitted to attend and participate in meetings of the board of directors and to receive all information provided to members of the board (including minutes of board meetings), but shall not permitted to formally vote on matters submitted for a vote. YALE shall be responsible for paying costs and expenses such observer to attend the meetings. LICENSEE will make commercially reasonable efforts to provide call-in access to such meetings. For clarity, YALE shall have no observer rights under
|
5.1
|
LICENSEE shall pay to YALE for the first LICENSED PRODUCT or PRODRUG PRODUCT developed by LICENSEE, SUBLICENSEE, or AFFILIATE a non- refundable milestone payment of [***] within 6 months of when LICENSEE, SUBLICENSEE, or AFFILIATE receives MARKETING APPROVAL for such a LICENSED PRODUCT or PRODRUG PRODUCT.
|
5.2
|
The milestone payment of Article 5.1 shall not be credited against EARNED ROYALTIES payable under Article 6.1 or any other payment due under this AMENDED AGREEMENT.
|
6.1
|
During the TERM, as partial consideration for the LICENSE, LICENSEE shall pay to YALE an earned royalty on annual cumulative NET SALES of LICENSED PRODUCTS (“EARNED ROYALTIES”), on a country-by-country basis, according to the following Schedule 6.1(a) in this Article 6.1:
|
EARNED ROYALTY in countries with a VALID CLAIM
under LICENSED PATENTS |
[***]
|
6.2
|
During the TERM, but not to exceed [***] years from the FIRST SALE of a PRODRUG PRODUCT, as partial consideration for YALE entering into this AMENDED AGREEMENT, LICENSEE shall pay to YALE a fee on annual cumulative NET SALES of PRODRUG PRODUCTS, on a country-by-country basis, according to the following Schedule 6.2(a) in this Article 6.2 (“PRODRUG FEE”):
|
PRODRUG FEE in countries with a VALID CLAIM under
PRODRUG PATENTS |
[***]
|
6.3
|
Stacking
. The payment amounts stated in Articles 6.1 and 6.2 are subject to a maximum not to exceed, in total, [***] of the combined annual NET SALES of LICENSED PRODUCTS and PRODRUG PRODUCTS, on a country-by-country basis, in countries where there is a VALID CLAIM. There shall be no other stacking of payments due to YALE for NET SALES of LICENSED PRODUCTS and PRODRUG PRODUCTS.
|
6.4
|
In the event that (i) LICENSEE or any of its AFFILIATES or SUBLICENSEES brings a PATENT CHALLENGE anywhere in the world, or (ii) LICENSEE or any of its AFFILIATES or SUBLICENSEES assists another party in bringing a PATENT CHALLENGE anywhere in the world (except as required under a court order or subpoena), and (iii) YALE does not choose to exercise its rights to terminate this AMENDED AGREEMENT pursuant to Article 13, then the following provisions shall apply.
|
(a)
|
All payments due to YALE under this AMENDED AGREEMENT other than patent costs shall be tripled during the pendency of the PATENT CHALLENGE and shall remain payable to YALE when due.
|
(b)
|
If the PATENT CHALLENGE is inconclusive or results in a determination that at least one challenged claim is both valid and infringed,
|
(1)
|
all payments due to YALE under this AMENDED AGREEMENT other than patent costs shall be tripled for the remainder of the TERM.
|
(2)
|
LICENSEE shall promptly reimburse YALE for all legal fees and expenses incurred in YALE’s defense against the PATENT CHALLENGE.
|
(c)
|
In the event that such a PATENT CHALLENGE is successful, LICENSEE will have no right to recoup any payments made prior to the final, non-appealable determination of a court of competent jurisdiction.
|
6.5
|
Neither LICENSEE nor any of its AFFILIATES or SUBLICENSEES shall bring a PATENT CHALLENGE without first providing YALE three (3) months written notice setting forth (a) precisely which claims and patents are being challenged or claimed not to be infringed, (b) a clear statement of the factual and legal basis for the challenge, and (c) an identification of all prior art and other matter believed to invalidate any claim of the LICENSED PATENT or which supports the claim that the LICENSED PATENT is not infringed.
|
6.6
|
LICENSEE shall pay all EARNED ROYALTIES and PRODRUG FEES accruing to YALE within [***] days from the end of each calendar quarter (March 31, June 30, September 30 and December 31), beginning in the first calendar quarter in which NET SALES occur. Unless YALE requests otherwise, LICENSEE shall report all EARNED ROYALTIES, PRODRUG FEES and other payments accruing to YALE on a quarterly basis, but shall defer payments accruing to YALE that do not, in total, exceed [***] in any given quarter until the earlier of (1) the end of the calendar year, or (2) the quarter upon which the cumulative accrued royalties and other payments exceed [***]. All payments shall be made by wire transfer pursuant to the instructions in Exhibit 6.6, which is attached and incorporated herein.
|
6.7
|
Minimum Payments
. During the TERM, LICENSEE agrees to pay YALE annual Minimum Payments (“MP”), commencing on the first January 1 to occur after the date of the FIRST SALE that results in NET SALES. The MP shall be payable to YALE in the amounts indicated in the following schedule:
|
Years after FIRST SALE
|
MP
|
[***]
|
$ [***]
|
[***]
|
$ [***]
|
[***]
|
$ [***]
|
[***]
|
$ [***]
|
6.8
|
If, during the TERM on a country-by-country basis and on a LICENSED PRODUCT- by-LICENSED PRODUCT basis or PRODRUG PRODUCT-by-PRODRUG PRODUCT basis, there are sales of one or more GENERICS by one or more THIRD PARTIES in such country in a calendar quarter, the EARNED ROYALTIES payable to YALE with respect to NET SALES of such a LICENSED PRODUCT by LICENSEE, a
|
(a)
|
[***];
|
(b)
|
[***];
|
(c)
|
[***];
|
(d)
|
[***];
|
(e)
|
[***];
|
(f)
|
[***]; and
|
(g)
|
[***].
|
(i)
|
[***] and
|
(ii)
|
[***]
|
(h)
|
No reductions due to GENERIC(S) under this Article 6.8 shall be permitted without reporting on a country-by-country basis of the actual determination of the amount of GENERIC sales of a given LICENSED PRODUCT or PRODRUG PRODUCT. Such a report shall be provided pursuant to Section 9.1.
|
6.9
|
[[***].
|
6.10
|
[***].
|
7.1
|
LICENSEE shall not SUBLICENSE the rights granted to it under this AMENDED AGREEMENT to any SUBLICENSEE without the prior written consent of YALE, unless such a SUBLICENSE is to a QUALIFIED SUBLICENSEE. In the event YALE consents to a SUBLICENSE under this Article 7.1, in addition to any other terms and conditions YALE may require, the provisions of Articles 7.2, 7.3 and 7.4 shall apply.
|
7.2
|
Any SUBLICENSE granted by LICENSEE to a SUBLICENSEE shall include substantially the same definitions and provisions, and such other provisions as are needed to enable LICENSEE to provide Yale the protections and benefits contemplated herein. LICENSEE will provide YALE with a copy of each SUBLICENSE agreement (and all amendments thereof) promptly after execution. LICENSEE shall also include provisions in all SUBLICENSES to provide that in the event that SUBLICENSEE brings a PATENT CHALLENGE anywhere in the world or assists another party in bringing a PATENT CHALLENGE anywhere in the world (except as required under a court order or subpoena) then LICENSEE shall immediately terminate the SUBLICENSE. LICENSEE shall remain responsible for the performance of all SUBLICENSEES under any such SUBLICENSE as if such performance were carried out by LICENSEE itself, including, without limitation, the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any SUBLICENSE provide for such amounts to be paid by the SUBLICENSEE directly to YALE. A breach of this provision shall constitute a material breach that is subject to Article 13.1(b).
|
7.3
|
LICENSEE shall pay royalties or fees to YALE on NET SALES of SUBLICENSEES based on the same royalty rate as apply to NET SALES by LICENSEE and its AFFILIATES, regardless of the royalty rates payable by SUBLICENSEES to LICENSEE under a SUBLICENSE. In addition:
|
(a)
|
[***];
|
(b)
|
[***];
|
(c)
|
[***].
|
7.4
|
LICENSEE agrees that it has sole responsibility to promptly:
|
(a)
|
provide YALE with a copy of any amendments to SUBLICENSES granted by LICENSEE under this AMENDED AGREEMENT to SUBLICENSEES and to notify YALE of termination of any such SUBLICENSE; and
|
(b)
|
deliver copies of all reports provided to LICENSEE by SUBLICENSEES. Such reports from SUBLICENSEES shall include the information required to be provided by LICENSEE and at the intervals required under Article 4.3; and
|
(c)
|
provide YALE with notice of the existence of any INVENTOR AGREEMENT(S) and notify YALE when such INVENTOR AGREEMENTS are no longer in effect, in any event, no less than once per year during the TERM.
|
8.1
|
Subject to the parties’ rights and obligations pursuant to this AMENDED AGREEMENT, YALE and LICENSEE agree that during the term of this AMENDED AGREEMENT and for [***] years thereafter, each of them:
|
(a)
|
will keep confidential and will cause their AFFILIATES and, in the case of LICENSEE, its SUBLICENSEES, to keep confidential, CONFIDENTIAL INFORMATION disclosed to it by the other party, by taking whatever action the party receiving the CONFIDENTIAL INFORMATION would take to preserve the confidentiality of its own CONFIDENTIAL INFORMATION, which in no event shall be less than reasonable care; and
|
(b)
|
will only disclose that part of the other’s CONFIDENTIAL INFORMATION to its AFFILIATES and its or their directors, officers, employees or agents, SUBLICENSEES and assignees under requirements of confidentiality, for purposes of carrying out its rights and responsibilities under this AMENDED AGREEMENT, or to potential or actual investors, underwriters or acquirers, and external advisors that are directly concerned with performance under this AMENDED AGREEMENT, on a strictly applied “need to know” basis;
provided
,
however
, that such AFFILIATES, directors, officers, employees, agents, SUBLICENSEES assignees, potential or actual investors, underwriters or acquirers, and external advisors are subject to confidentiality obligations at least as stringent as the confidentiality obligations provided for in this Article 8 or are otherwise bound by professional obligations of confidentiality; and
|
(c)
|
will not use the other party’s CONFIDENTIAL INFORMATION other than as expressly permitted by this AMENDED AGREEMENT or disclose the other’s CONFIDENTIAL INFORMATION to any THIRD PARTIES (other than to agents under requirements of confidentiality) under any circumstance without advance written permission from the other party; and
|
(d)
|
will, within [***] of termination of this AMENDED AGREEMENT, return all the CONFIDENTIAL INFORMATION disclosed to it by the other party pursuant to this AMENDED AGREEMENT except for one copy which may be retained by the recipient for monitoring compliance with this Article 8 and any surviving clauses, and provided further that the recipient shall not be required to delete CONFIDENTIAL INFORMATION of the disclosing party from its computer back-up storage that is stored securely.
|
8.2
|
The obligations of confidentiality described above shall not pertain to that part of the CONFIDENTIAL INFORMATION that:
|
(a)
|
is shown to have been known to or developed by the recipient prior to the disclosure by the disclosing party; or
|
(b)
|
is at the time of disclosure or has become thereafter publicly known through no fault or omission attributable to the recipient; or
|
(c)
|
is rightfully given to the recipient from sources independent of the disclosing party; or
|
(d)
|
is independently developed by the receiving party without use of or reference to the CONFIDENTIAL INFORMATION of the other party; or
|
(e)
|
is required to be disclosed by law in the opinion of recipient’s attorney, but only after the disclosing party is given prompt written notice and an opportunity to seek a protective order.
|
8.3
|
The financial terms of this AMENDED AGREEMENT constitute CONFIDENTIAL INFORMATION of each party.
|
9.1
|
LICENSEE shall, within [***] days after the calendar year in which NET SALES first occur, and within [***] days after each calendar quarter (March 31, June 30, September 30 and December 31) thereafter, provide YALE with a written report detailing the NET SALES and uses, if any, made by LICENSEE, its SUBLICENSEES and AFFILIATES of LICENSED PRODUCTS and PRODRUG PRODUCTS during the preceding calendar quarter and calculating the payments due pursuant to Article 6. NET SALES of LICENSED PRODUCTS and PRODRUG PRODUCTS shall be deemed to have occurred on the date of invoice for such LICENSED PRODUCTS. Each such report shall be signed by an officer of LICENSEE (or the officer’s designee), shall be in the form of Exhibit 9.1, which is attached and incorporated herein, and must include:
|
(a)
|
the number or amount, as appropriate, of LICENSED PRODUCTS and PRODRUG PRODUCTS manufactured, sold, practiced, leased or otherwise transferred or disposed of by LICENSEE, SUBLICENSEES and AFFILIATES;
|
(b)
|
a calculation of NET SALES for the applicable reporting period in each country, including the gross invoice prices charged for the LICENSED PRODUCTS and PRODRUG PRODUCTS and any permitted deductions made pursuant to Article 2.26, Article 6.8, and/or Article 6.9;
|
(c)
|
a calculation of total royalties or other payment due, including any exchange rates used for conversion; and
|
(d)
|
names and addresses of all SUBLICENSEES and the type and amount of any SUBLICENSE INCOME received from each SUBLICENSEE.
|
9.2
|
LICENSEE, AFFILIATES and its SUBLICENSEES shall keep and maintain complete and accurate records and books containing an accurate accounting of all data in sufficient detail to enable verification of EARNED ROYALTIES, PRODRUG FEES and other payments under this AMENDED AGREEMENT. LICENSEE shall preserve such books and records for [***] years after the calendar year to which they pertain. Such books and records shall be open to inspection by YALE or an independent certified public accountant selected by YALE, at YALE’s expense, no more frequently than once per year, during normal business hours upon [***] days’ prior written notice, for the purpose of verifying the accuracy of the reports and computations rendered by LICENSEE. In the event LICENSEE underpaid the amounts due to YALE with respect to the audited period by more than [***] ([***]%), LICENSEE shall pay the reasonable cost of such examination, together with the deficiency not previously paid and interest from the due date of such payment, calculated at the rates set forth in Article 6.8 and Article 6.9, within [***] days of receiving notice thereof from YALE.
|
10.1
|
LICENSEE shall be responsible for past United States patent expenses for which Yale has not received reimbursement, and present and future on-going costs of filing, prosecution and maintenance of all United States patent applications contained in the LICENSED PATENTS. Any and all such United States patent applications, and resulting issued patents, shall remain the property of YALE.
|
10.2
|
LICENSEE shall be responsible for past foreign patent expenses for which Yale has not received reimbursement, and present and future on-going costs of filing, prosecution and maintenance of all foreign patent applications, and patents contained in the LICENSED PATENTS in the countries outside the United States in the LICENSED TERRITORY selected by YALE and agreed to by LICENSEE. [All such applications or patents shall remain the property of YALE.] LICENSEE acknowledges that YALE shall not be required to file any such applications in low or lower-middle income countries, as designated by the World Bank (www.worldbank.org). Furthermore, LICENSEE agrees not to file any patent rights that are owned by LICENSEE and that claim LICENSED PRODUCTS in any such low-income or lower-middle income countries.
|
10.3
|
If, upon the request of YALE, LICENSEE does not agree in writing to pay the expenses of filing, prosecuting or maintaining a given patent application or a given patent in any country outside the United States, or fails to pay the expenses of filing, prosecuting or maintaining a given patent application or patent in the United States, then LICENSEE’s rights under this AMENDED AGREEMENT shall terminate automatically with respect to that given patent in that country.
|
10.4
|
The costs mentioned in Articles 10.2 and 10.3 shall include, but are not limited to, any past, present and future taxes, annuities, working fees, maintenance fees, renewal and extension charges. Payment of such costs shall be made, at YALE’s option, either directly to patent counsel or by reimbursement to YALE. In either case, LICENSEE shall make payment directly to the appropriate party within [***] days of receiving its invoice.
|
10.5
|
All patent applications under the LICENSED PATENTS shall be prepared, prosecuted, filed and maintained by independent patent counsel chosen by YALE and reasonably acceptable to LICENSEE. Said independent patent counsel shall be ultimately responsible to YALE. YALE shall instruct patent counsel to keep both YALE and LICENSEE fully informed of the progress of all patent applications and patents, and to give both YALE and LICENSEE reasonable opportunity to comment on the type and scope of useful claims and the nature of supporting disclosures. YALE will not finally abandon any patent application for which LICENSEE is bearing expenses without LICENSEE’s consent. YALE shall have no liability to LICENSEE for damages, whether direct, indirect or incidental, consequential or otherwise, allegedly arising from its good faith decisions, actions and omissions in connection with such prosecution.
|
10.6
|
LICENSEE shall mark, and shall require AFFILIATES and SUBLICENSEES to mark, all LICENSED PRODUCTS, that are tangible products, with the numbers of all patents included in LICENSED PATENTS that cover the LICENSED PRODUCTS. Without limiting the foregoing, all LICENSED PRODUCTS shall be marked in such a manner as to conform with the patent marking notices required by the law of any country where such LICENSED PRODUCTS are made, sold, used or shipped, including, but not limited to, the applicable patent laws of that country.
|
11.1
|
Each party shall promptly notify the other in writing in the event that it obtains knowledge of infringing activity by THIRD PARTIES, or is sued or threatened with an infringement suit, in any country in the LICENSED TERRITORY as a result of activities that concern the LICENSED PATENTS, and shall supply the other party with documentation of the infringing activities that it possesses.
|
11.2
|
During the TERM:
|
(a)
|
LICENSEE shall have the first right to defend the LICENSED PATENTS against infringement or interference in the FIELD and in the LICENSED TERRITORY by THIRD PARTIES. This right includes bringing any legal action for infringement and defending any counter claim of invalidity or action of a THIRD
|
(b)
|
Except as provided in Article 11(a) above, in the event LICENSEE fails to initiate and pursue or participate in the actions described in Article (a) within [***] days of (a) notification of infringement from YALE or (b) the date LICENSEE otherwise first becomes aware of an infringement, whichever is earlier, YALE may, in its sole discretion, convert the LICENSE granted in Article 3 only in the jurisdiction subject to such alleged infringement to a nonexclusive license, and issue licenses to THIRD PARTIES under the LICENSED PATENTS to make, have made, use, sell, have sold, import, or practice LICENSED PRODUCTS within the FIELD in the applicable jurisdiction within the LICENSED TERRITORY. Additionally, YALE shall have the right to initiate legal action such as that described in Article 11(a) at its own expense and YALE may use the name of LICENSEE as party plaintiff to uphold the LICENSED PATENTS in such jurisdiction. In such case, LICENSEE shall provide reasonable assistance to YALE if requested to do so. YALE may settle such actions solely through its own counsel. Any recovery shall be retained by YALE.
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(c)
|
In the event LICENSEE is permanently enjoined from exercising its LICENSE under this AMENDED AGREEMENT pursuant to an infringement action brought by a THIRD PARTY, or if both LICENSEE and YALE elect not to undertake the defense or settlement of a suit alleging infringement for a period of [***] months from notice of such suit, then either party shall have the right to terminate this AMENDED AGREEMENT in the country where the suit was filed with respect
|
(d)
|
Notwithstanding the foregoing, neither LICENSEE nor YALE shall take any action to enforce the LICENSED PATENTS, or patent rights owned by LICENSEE and which claim the LICENSED PRODUCTS, in DEVELOPING ECONOMIES, where such action is intended to prevent the sale of LICENSED PRODUCTS solely in any such countries. However, LICENSEE and/or YALE may take such action in any such country, provided that such action is intended to prevent the manufacturing of LICENSED PRODUCTS for export to countries that DEVELOPING ECONOMIES.
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12.1
|
LICENSEE shall not use the name “Yale” or “Yale University,” nor any variation or adaptation thereof, nor any trademark, tradename or other designation owned by YALE, nor the names of any of its trustees, officers, faculty, students, employees or agents, for any purpose without the prior written consent of YALE in each instance, such consent to be granted or withheld by YALE in its sole discretion, except that LICENSEE may state that it has licensed from YALE one or more of the patents and/or applications comprising the LICENSED PATENTS.
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13.1
|
In the event LICENSEE permanently discontinues its research, development, or commercialization of all PRODRUG PRODUCTS, due to safety or efficacy concerns, failure to achieve desired outcomes in CLINICAL TRIALS, commercial considerations, or otherwise: LICENSEE shall promptly provide notice to YALE in accordance with Article 4.5, and this AMENDED AGREEMENT shall automatically terminate and the ORIGINAL AGREEMENT shall be revived as of the EFFECTIVE DATE;
provided
,
however
, that the assignment of the ORIGINAL AGREEMENT from BIOHAVEN to LICENSEE shall remain in effect, and any obligations of the parties that have been performed prior to the notice an accordance with Article 4.5 shall be recognized by the parties as completed and discharged. For clarity, as of the AMENDED EFFECTIVE DATE, LICENSEE’s obligations under Articles 4.6(f)(1)(2) and (3), 4.7 (so long as LICENSEE is a PUBLICLY TRADED COMPANY), 5.1, 5.4 and 5.5 of the ORIGINAL AGREEMENT, are hereby recognized by the parties as completed and discharged.
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13.2
|
YALE shall have the right to terminate this AMENDED AGREEMENT upon [***] day’s prior written notice to LICENSEE in the event LICENSEE:
|
(a)
|
fails to make any payment whatsoever due and payable pursuant to this AMENDED AGREEMENT unless LICENSEE shall make all such payments (and all interest due on such payments under Article 6.4) within the [***] day period after receipt of written notice from YALE; or
|
(b)
|
commits a material breach of any other material provision of this AMENDED AGREEMENT which is not cured (if capable of being cured) within the [***] day period after receipt of written notice thereof from YALE, or upon receipt of such notice if such breach is not capable of being cured; or
|
(c)
|
fails to obtain or maintain adequate insurance as described in Article 14.2, whereupon YALE may terminate this AMENDED AGREEMENT immediately upon written notice to LICENSEE.
|
(d)
|
If LICENSEE or any of its AFFILIATES brings a PATENT CHALLENGE against YALE, or assists others in bringing a PATENT CHALLENGE against YALE (except as required under a court order or subpoena), whereupon YALE may terminate this AMENDED AGREEMENT immediately, unless YALE raises the royalty rate pursuant to Article 6.4.
|
(e)
|
If a SUBLICENSEE brings a PATENT CHALLENGE or assists another party in bringing a PATENT CHALLENGE (except as required under a court order or subpoena), then YALE may send a written demand to LICENSEE to terminate such SUBLICENSE. If LICENSEE fails to so terminate such SUBLICENSE within [***] days after YALE’s demand, YALE may immediately terminate this AMENDED AGREEMENT unless YALE raises the royalty rate pursuant to Article 6.4.
|
13.3
|
This AMENDED AGREEMENT shall terminate automatically without any notice to LICENSEE in the event LICENSEE shall cease to carry on its business or becomes INSOLVENT, or a petition in bankruptcy is filed against LICENSEE and is consented to, acquiesced in or remains undismissed for [***] days, or LICENSEE makes a general assignment for the benefit of creditors, or a receiver is appointed for LICENSEE.
|
13.4
|
LICENSEE shall have the right to terminate this AMENDED AGREEMENT upon written notice to YALE:
|
(a)
|
at any time on [***] months’ notice to YALE, provided LICENSEE is not in breach and upon payment of all amounts due YALE throughout the effective date of termination; or
|
(b)
|
in the event YALE commits a material breach of any of the provisions of this AMENDED AGREEMENT and such breach is not cured (if capable of being cured) within the [***] day period after receipt of written notice thereof from LICENSEE, or upon receipt of such notice if such breach is not capable of being cured; or
|
(c)
|
as to a specific country if no VALID CLAIMS covering LICENSED PRODUCTS exist in such country pursuant to (i) or (ii) in Article 2.42 or as provided in ARTICLE 11.2(c).
|
13.5
|
Upon termination of this AMENDED AGREEMENT, for any reason other than a material breach by YALE, all rights and licenses granted to LICENSEE under the terms of this AMENDED AGREEMENT are terminated and YALE has the option, in its discretion, to terminate any SUBLICENSE granted by LICENSEE to SUBLICENSEES. Upon such termination, LICENSEE shall cease to make, have made, use, sell, have sold, distribute, practice, import or export LICENSED PRODUCTS. Within [***] days of the effective date of termination LICENSEE shall return to YALE:
|
(a)
|
All materials relating to or containing the LICENSED PATENTS, LICENSED PRODUCTS or CONFIDENTIAL INFORMATION disclosed by YALE;
|
(b)
|
the last report required under Article 4 or Article 9; and
|
(c)
|
all payments incurred up to the effective date of termination.
|
13.6
|
Termination of this AMENDED AGREEMENT shall not affect any rights or obligations of either party accrued prior to the effective date of such termination. LICENSEE’s obligation to pay all milestones under Article 5, all fees under Article 6 (other than Article 6.1), and Article 6.10, SUBLICENSE INCOME under Article 7.3(b) shall survive such a termination of the AMENDED AGREEMENT. In particular, but without limitation, the following additional provisions shall survive any termination: Article 2, Article 8, the preservation and inspection obligations of Article 9, Article 11, Article 12, this Article 13.6, Article 13.9, Article 14, Article 15, Article 17.1, and Article 18. The parties agree that claims giving rise to indemnification may arise after the TERM or termination of the LICENSE granted herein.
|
13.7
|
The rights provided in this Article 13 shall be in addition and without prejudice to any other rights, whether at law or in equity, which the parties may have with respect to any default or breach of the provisions of this AMENDED AGREEMENT.
|
13.8
|
Waiver by either party of one or more defaults or breaches shall not deprive such party of the right to terminate because of any subsequent default or breach.
|
13.9
|
Upon termination of this AMENDED AGREEMENT for any reason other than breach by YALE, LICENSEE shall permit YALE and its future licensees to utilize, reference and otherwise have the benefit of all regulatory approvals of, or clinical trials or other studies conducted on, and all filings made with regulatory agencies with respect to, the LICENSED PRODUCTS. In addition, at YALE’s request, LICENSEE shall deliver to YALE within six months of such request all records required by regulatory authorities to be maintained with respect to the sale, storage, handling, shipping and use of the LICENSED PRODUCTS, all reimbursement approval files, all documents, data and information related to clinical trials and other studies of LICENSED PRODUCTS, any other data, techniques, know-how and other information developed or generated that relate to the LICENSED PATENTS or LICENSED PRODUCTS, and all copies and facsimiles of such materials, documents, information and files. YALE agrees that,
|
14.1
|
LICENSEE shall indemnify, defend by counsel acceptable to YALE, and hold harmless YALE and its trustees, officers, employees, and agents (collectively, “YALE Indemnitees”), from and against any claim, liability, cost, expense, damage, deficiency, loss, or obligation, of any kind or nature (including, without limitation, reasonable attorneys’ fees and other costs and expenses of defense) (collectively, “CLAIMS”), based upon, arising out of or otherwise relating to this LICENSE, including without limitation any cause of action relating to product liability, or any theory of liability (including without limitation tort, warranty, or strict liability) or the death, personal injury, or illness of any person or out of damage to any property related in any way to the rights granted under this AMENDED AGREEMENT; or resulting from the production, manufacture, sale, use, lease, or other disposition or consumption or advertisement of the LICENSED PRODUCTS or PRODRUG PRODUCTS by LICENSEE, its AFFILIATES, SUBLICENSEES or any other transferees; or in connection with any statement, representation or warranty of LICENSEE, its AFFILIATES, SUBLICENSEES or any other transferees with respect to the LICENSED PRODUCTS or PRODRUG PRODUCTS. LICENSEE shall not settle or compromise the CLAIM relating to LICENSED PRODUCTS without the prior written consent of YALE, such consent not to be unreasonably withheld or delayed. Without limiting the foregoing, YALE may withhold its consent to any settlement or compromise that would in any manner constitute or incorporate an admission by YALE or require YALE to take or refrain from taking any action.
|
14.2
|
Subject to the timing requirements set forth in ARTICLE 14.3, LICENSEE shall purchase and maintain in effect and shall require its SUBLICENSEES to purchase and maintain in effect a policy of commercial, general liability insurance to protect YALE with respect to events described in Article 14.1. Such insurance shall:
|
(a)
|
list “YALE, its trustees, directors, officers, employees and agents” as additional insured parties under the policy;
|
(b)
|
provide that such policy is primary and not excess or contributory with regard to other insurance YALE may have;
|
(c)
|
be endorsed to include product liability coverage in amounts no less than [***] Dollars ($[***]) per incident and [***] Dollars ($[***]) annual aggregate; and
|
(d)
|
be endorsed to include contractual liability coverage for LICENSEE’s indemnification under Article 14.1; and
|
(e)
|
by virtue of the minimum amount of insurance coverage required under Article 14.2(c), not be construed to create a limit of LICENSEE’s liability with respect to its indemnification under Article 14.1.
|
14.3
|
By signing this AMENDED AGREEMENT, LICENSEE certifies that the requirements of Article 14.2 will be met on or before the earlier of (a) the date of FIRST SALE of any LICENSED PRODUCT or (b) the date any LICENSED PRODUCT is tested or used on humans, and will continue to be met thereafter. Upon YALE’s request, LICENSEE shall furnish a Certificate of Insurance and a copy of the current insurance policy to YALE. LICENSEE shall secure agreement from its insurer to give [***] days’ written notice to YALE prior to any cancellation of or material change to the policy.
|
(a)
|
YALE MAKES NO, AND EXPRESSLY DISCLAIMS ALL, REPRESENTATIONS OR WARRANTIES THAT ANY CLAIMS OF THE LICENSED PATENTS, ISSUED OR PENDING, ARE VALID, OR THAT THE MANUFACTURE, USE, PRACTICE, SALE OR OTHER DISPOSAL OF THE LICENSED PRODUCTS DOES NOT OR WILL NOT INFRINGE UPON ANY PATENT OR OTHER RIGHTS NOT VESTED IN YALE.
|
(b)
|
YALE MAKES NO, AND EXPRESSLY DISCLAIMS ALL, REPRESENTATIONS AND WARRANTIES WHATSOEVER WITH RESPECT TO THE LICENSED PATENTS AND LICENSED PRODUCTS, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
|
(c)
|
LICENSEE SHALL MAKE NO STATEMENTS, REPRESENTATION OR WARRANTIES WHATSOEVER TO ANY THIRD PARTIES THAT ARE INCONSISTENT WITH THE DISCLAIMERS BY YALE IN ARTICLE 14.3(a) AND (b).
|
(d)
|
IN NO EVENT SHALL YALE, OR ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER YALE SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
|
(e)
|
IN NO EVENT SHALL YALE, OR ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES, BE LIABLE FOR DAMAGES IN EXCESS OF AMOUNTS YALE HAS RECEIVED FROM LICENSEE UNDER THIS LICENSE.
|
15.1
|
Any monetary payment, notice or other communication required by this AMENDED AGREEMENT (a) shall be in writing, (b) may be delivered personally or sent by reputable overnight courier with written verification of receipt or by registered or certified first class United States Mail, postage prepaid, return receipt requested, (c) shall be sent to the following addresses or to such other address as such party shall designate by written notice to the other party, and (d) shall be effective upon receipt:
|
FOR YALE:
Managing Director
YALE UNIVERSITY
Office of Cooperative Research
433 Temple Street
New Haven, CT 06511
|
FOR LICENSEE:
President and CEO
Biohaven Therapeutics Ltd.
215 Church Street
New Haven, CT 06371
|
|
|
With an electronic copy sent to:
OCRAgreements@yale.edu
Referencing OCR4001
|
|
16.1
|
If LICENSEE and INVENTOR enter into an INVENTOR AGREEMENT, LICENSEE shall so notify YALE in writing within [***] days. The LICENSEE acknowledges that: (i) the INVENTOR is a faculty member, other employee, or student of YALE; (ii) the INVENTOR is subject to certain policies of YALE, as such policies may be revised from time to time, including policies concerning consulting, conflicts of interest, and intellectual property (“YALE POLICIES”); (iii) to the extent any provision of the INVENTOR AGREEMENT conflicts with YALE POLICIES, or imposes obligations or responsibilities compliance with which would require the INVENTOR to act in violation of YALE POLICIES, such provision shall be void. INVENTOR is a THIRD PARTY beneficiary of this paragraph.
|
17.1
|
Any matter arising out of or related to this AMENDED AGREEMENT shall be governed by and in accordance with the substantive laws of the State of Connecticut, without regard to its conflicts of law principles, except where the federal laws of the United States are applicable and have precedence. Any dispute arising out of or related to this AMENDED AGREEMENT shall be brought exclusively in a court of competent jurisdiction in the State of Connecticut, and the parties hereby irrevocably submit to the jurisdiction of such courts.
|
17.2
|
LICENSEE shall comply, and shall cause its AFFILIATES and SUBLICENSEES to comply, with all foreign and United States federal, state, and local laws, regulations, rules and orders applicable to the testing, production, transportation, packaging, labeling,
|
18.1
|
This AMENDED AGREEMENT shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns.
|
18.2
|
This AMENDED AGREEMENT, and the ORIGINAL AGREEMENT in the event it is revived under Article 13.1, constitute the entire agreement of the parties relating to the LICENSED PATENTS, LICENSED PRODUCTS, PRODRUG PATENTS and PRODRUG PRODUCTS and all prior representations, other agreements and understandings, written or oral, are merged into it and are superseded by this AMENDED AGREEMENT.
|
18.3
|
The provisions of this AMENDED AGREEMENT shall be deemed separable. If any part of this AMENDED AGREEMENT is rendered void, invalid, or unenforceable, such determination shall not affect the validity or enforceability of the remainder of this AMENDED AGREEMENT unless the part or parts which are void, invalid or unenforceable shall substantially impair the value of the entire AMENDED AGREEMENT as to either party.
|
18.4
|
Paragraph headings are inserted for convenience of reference only and do not form a part of this AMENDED AGREEMENT.
|
18.5
|
No person not a party to this AMENDED AGREEMENT, including any employee of any party to this AMENDED AGREEMENT, shall have or acquire any rights by reason of this AMENDED AGREEMENT. Nothing contained in this AMENDED AGREEMENT shall be deemed to constitute the parties, partners or joint venturers with each other or any THIRD PARTY, and neither party shall be deemed the agent of the other.
|
18.6
|
This AMENDED AGREEMENT may not be amended or modified except by written agreement executed by each of the parties.
|
18.7
|
This AMENDED AGREEMENT is personal to LICENSEE and shall not be assigned by LICENSEE without the prior written consent of YALE, which consent shall not be unreasonably withheld, conditioned or delayed; except that LICENSEE shall have the right, without such consent, (i) to perform any or all of its obligations and exercise any or all of its rights under this AMENDED AGREEMENT through any of its AFFILIATES, (ii) assign any or all of its rights and delegate any or all of its obligations hereunder to any of its AFFILIATES; and (iii) assign this AMENDED AGREEMENT in its entirety to a QUALIFIED ASSIGNEE. Any attempted assignment in contravention of this Article 18.7 shall be null and void and shall constitute a material breach of this AMENDED AGREEMENT. Notwithstanding anything to the contrary in this
|
18.8
|
LICENSEE, or any SUBLICENSEE or assignee, will not create, assume or permit to exist any lien, pledge, security interest or other encumbrance on this AMENDED AGREEMENT or any SUBLICENSE.
|
18.9
|
The failure of any party hereto to enforce at any time, or for any period of time, any provision of this AMENDED AGREEMENT shall not be construed as a waiver of either such provision or of the right of such party thereafter to enforce each and every provision of this AMENDED AGREEMENT.
|
18.10
|
This AMENDED AGREEMENT may be executed in any number of counterparts and any party may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument.
|
YALE UNIVERSITY
|
BIOHAVEN THERAPEUTICS LTD.
|
By:
/s/ Jon Soderstrom
E. Jonathan Soderstrom, Ph.D.
Managing Director
Office of Cooperative Research
|
By:
/s/ Donnie McGrath, M.D.
Donnie McGrath, M.D.
Authorized Signatory
|
|
|
Date:
7 May 2019
|
Date:
9 May 2019
|