Exhibit 4.9


 


EXECUTION
COPY


 


MILESTONE, ROYALTY AND SUBLICENSING
FEE DEED


 


This
MILESTONE, ROYALTY AND SUBLICENSING FEE deed (this “Deed”) is made and entered into as of February
27, 2014, by and between Elan Pharma International Limited, a private limited company incorporated in Ireland (“EPIL”),
and Elan Science Ten Limited, a private limited company incorporated in Ireland (the “Company”). EPIL and the
Company are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Capitalized terms used in this Deed have the meanings ascribed to them in ARTICLE IV.


 


WHEREAS, the
Company is in the business of researching, developing, manufacturing and commercializing any pharmaceutical preparation or dosage
form containing Scyllo-Inositol and any compounds identified, obtained, developed, created, synthesized, generated, designed or
resulting from, based upon, containing or incorporating the chemical structure of Scyllo-Inositol as those compounds are generically
and/or specifically disclosed and claimed in the Product Patents (the “Product”; and such business is referred
to herein as the “Business”);


 


NOW, THEREFORE,
in consideration of the premises, representations, warranties, mutual covenants and agreements hereinafter set forth, and for good
and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby covenant and
agree as follows:


 


ARTICLE
I

CONSIDERATION PAYABLE TO EPIL


 


1.1         Milestone
Payments. The Company shall, within 45 days after the occurrence of each Milestone Event, make a one-time payment to EPIL
as follows:


 


(a)          $10,000,000
upon receipt by the Company of the first approval to manufacture, market and sell a pharmaceutical Product issued by the US Food
and Drug Administration, the European Medicines Agency or an equivalent Governmental Authority in any of the United States, Canada,
United Kingdom, Germany, France, Spain, Italy or Japan;


 


(b)          $15,000,000
to be paid upon the achievement of worldwide Net Sales of Products equal to or greater than $250,000,000 in one calendar year;
and


 


(c)          $15,000,000
to be paid upon the achievement of worldwide Net Sales of Products equal to or greater than $500,000,000 in one calendar year.


 


For the avoidance of
doubt, EPIL and the Company understand and agree that the Company shall make all decisions relating to the development and commercialization
of the Products in its sole discretion.


 




     


     


    

 


1.2         Royalty
Fees. The Company shall, on a quarterly basis commencing on the 45th day of the first fiscal quarter after the date on
which the First Commercial Sale of the Product occurs, pay to EPIL 6.5% of Net Sales for the life of the Product received by the
Company or any Affiliates at any time as a result of and/or due to the sale and/or supply of any and all Products that have attained
Commercial Regulatory Approval, it being understood that the Company and its Affiliates shall use reasonable
best efforts to achieve fair market value in respect of the sale and/or supply of such Products and, without limitation of the
foregoing, shall not offer or grant any non-customary discounts in respect of the sale and/or supply of the Products in the jurisdictions
of sale. For the avoidance of doubt, a Royalty Fee accrues on the date when any Product is sold and/or supplied, the date it is
being supplied being the earliest of when it is invoiced or paid for. 


 


1.3         Sublicense
Fees. The Company shall, on a quarterly basis commencing on the 45th day of the first fiscal quarter after Closing, pay
to EPIL six and one half percent (6.5%) of all payments received by the Company in the form of upfront payments, maintenance fees,
license fees or milestone payments in connection with sublicensing the Product Patents and/or Product Know-How, excluding any royalty
payments to the Company, it being understood that the Company and its Affiliates shall use reasonable best
efforts to achieve fair market value in negotiating and finalizing the terms for all such sublicensing arrangements and, without
limitation of the foregoing, shall not offer or grant any non-customary discounts in respect of the sublicense agreements. The
Sublicense Fees shall be payable under this Deed even if some part of the supply, license, rental or putting into use of the Products
by the Company takes place in any jurisdiction where there is no Product Patent or where the Product does not fall within the scope
of any Product Patent.


 


1.4         Method
of Payment. All amounts payable under this ARTICLE I shall be paid by wire transfer of immediately available funds
in U.S. dollars to an account designated in writing by EPIL, no later than three Business Days prior to the applicable payment
date; provided, that, in the event EPIL requests that such funds be converted into euro, the rate of exchange to
be applied shall be the rate of exchange applied by the Dublin bankers to EPIL for the purchase of euro with such foreign currency
as at the close of business on the date when the relevant payment first becomes due. In the event the Company is delayed in delivering
any of the Milestone Payments, Royalty Fees or Sublicense Fees as and when due, (a) the undisputed portion of the amount owed by
the Company shall accrue interest at the rate of 1.5% each month and such interest shall be paid in the same immediately available
funds to EPIL and (b) any disputed portion of such amount shall accrue interest at a rate per annum equal to the prime rate of
interest reported from time to time in The Wall Street Journal, calculated on the basis of the actual number of days elapsed over
360, from the date of payment until the time such dispute is settled, it being understood that the amount
of interest to be paid by the Company shall be calculated based on the amount finally agreed between the Parties and such interest
shall be paid in the same immediately available funds to EPIL. 


 


1.5         Tax
Withholding. All payments pursuant to this ARTICLE I shall be made to EPIL net of any withholding VAT, GST, sales
or use Taxes. In the event that the Company is required by law to pay or withhold any such Taxes in connection with any payment
under this ARTICLE I, the Company shall withhold and deduct such Taxes, and pay over such Taxes to the applicable Governmental
Authority. The Company shall provide EPIL with documentation of such withholding and shall pursue all Tax credits available to
diminish such Tax obligations. The Parties agree to co-operate in all respects necessary to take advantage of any double taxation
agreements or similar agreements as may from time to time, be available in order to the Company to make payments to EPIL without
deduction or withholding.


 




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ARTICLE
II


reports;
RECORDS; audit rights


 


2.1         Reports.
In connection with the payments made to EPIL under ARTICLE I, the Company shall furnish to EPIL: 


 


(a)          within
ten Business Days following the end of each Fiscal Quarter, a draft report showing (i) (A) the Net Sales accrued in connection
with the Products that have obtained Commercial Regulatory Approval and (B) payments accrued in connection with sublicensing the
Product Patents and/or Product Know-How, in each case, in respect of such Fiscal Quarter (or if none shall have accrued, a report
so stating), (ii) the amount of Milestone Payments, Royalty Fees and/or Sublicense Fees payable hereunder in respect of such Net
Sales and/or sublicensing payments received by the Company during such Fiscal Quarter as determined in accordance with Sections
1.1, 1.2 and 1.3, respectively, and (iii) (A) the Net Sales of the Products and number of units of the Products
sold in each of the top ten countries in the Territory (ranked based on total amount of annual Net Sales in such countries) and
the aggregate Net Sales of the Products and aggregate number of units of the Products sold in all other countries in the Territory
where the Products are sold during such Fiscal Quarter and (B) the payments received by the Company in connection with sublicensing
the Product Patents and/or Product Know-How in each of the top ten countries in the Territory (ranked based on total amount of
annual payments received in such countries) and the aggregate payments received by the Company in connection with sublicensing
the Product Patents and/or Product Know-How and aggregate number of the Product Patents and/or Product Know-How subject to sublicensing
arrangements in all other countries in the Territory where the Product Patents and/or Product Know-How are sublicensed during such
Fiscal Quarter, it being understood that the Company shall use its reasonable best efforts to obtain the information
required to be delivered to EPIL under this Section 2.1(a)(iii) and, in the event the Company is unable to obtain any portion
of such information, the Company shall give prompt notice to EPIL, describing the facts and circumstances that give rise to the
Company’s inability to fulfill its obligations hereunder and requesting EPIL’s consent to modify the scope of information
and/or time period in which such information is required to be furnished hereunder, which consent may not be unreasonably withheld,
delayed or conditioned by EPIL.


 


(b)          within
fifteen Business Days following the end of such Fiscal Quarter, a final report showing (i) (A) any Net Sales accrued in connection
with the Products that have obtained Commercial Regulatory Approval and (B) payments accrued in connection with sublicensing the
Product Patents and/or Product Know-How, in each case, in respect of such Fiscal Quarter (or if none shall have accrued, a report
so stating); provided, that if any adjustments are made to Net Sales in such Fiscal Quarter after delivery of the final
report, such adjustments shall be reflected and incorporated into the report for the following Fiscal Quarter, (ii) the amount
of Milestone Payments, Royalty Fees and/or Sublicense Fees payable hereunder in respect of such Net Sales and/or sublicensing payments
received by the Company during such Fiscal Quarter as determined in accordance with Sections 1.1, 1.2 and 1.3,
respectively and (iii) (A) the Net Sales of the Products and number of units of the Products sold in each of the top ten countries
in the Territory (ranked based on total amount of annual Net Sales in such countries) and the aggregate Net Sales of the Products
and aggregate number of units of the Products sold in all other countries in the Territory where the Products are sold during such
Fiscal Quarter and (B) the payments received by the Company in connection with sublicensing the Product Patents and/or Product
Know-How in each of the top ten countries in the Territory (ranked based on total amount of annual payments received in such countries)
and the aggregate payments received by the Company in connection with sublicensing the Product Patents and/or Product Know-How
and aggregate number of the Product Patents and/or Product Know-How subject to sublicensing arrangements in all other countries
in the Territory where the Product Patents and/or Product Know-How are sublicensed during such Fiscal Quarter, it being
understood that the Company shall use its reasonable best efforts to obtain the information required to be delivered to
EPIL under this Section 2.1(b)(iii) and, in the event the Company is unable to obtain any portion of such information, the
Company shall give prompt notice to EPIL, describing the facts and circumstances that give rise to the Company’s inability
to fulfill its obligations hereunder and requesting EPIL’s consent to modify the scope of information and/or time period
in which such information is required to be furnished hereunder, which consent may not be unreasonably withheld, delayed or conditioned
by EPIL.


 




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(c)          within
fifteen Business Days following the end of such Fiscal Quarter, a forecast report detailing the Company’s forecast for Net
Sales and sublicense payments for that full calendar year and for each of the remaining Fiscal Quarters in that calendar year;


 


(d)          a
preliminary Net Sales budget by November 15 of each year for the following calendar year;


 


(e)          a
final Net Sales budget by December 15 of each year (or, if later, immediately after approval of such budget by the Board of Directors
of the Company) for the following calendar year; and


 


(f)          the
exchange rates used in converting all Milestone Payments, Royalty Fees and/or Sublicense Fees payable in such Fiscal Quarter to
U.S. dollars from the currency in which the sales of the Products were made in accordance with Sections 1.1, 1.2
and 1.3.


 


Notwithstanding anything
herein to the contrary, EPIL shall be permitted to publicly disclose (1) country-level information with respect to the Products
in the United States and (2) aggregate information with respect to the Products, Product Patents and/or Product Know-How in the
rest of the world, in each case in Perrigo Company plc’s periodic filings with the SEC, earnings press releases and investor
and analyst conference calls and presentations but only as, and to the extent, required to comply with applicable Laws.


 


2.2         Records.
The Company shall maintain complete and accurate books and records in sufficient detail to enable EPIL and its Affiliates to (a)
calculate and verify Net Sales of the Products that have obtained Commercial Regulatory Approval payments accrued in connection
with sublicensing the Products, and (b) calculate and verify the Royalty Fees and/or Sublicense Fees payable hereunder in respect
of such Net Sales and/or sublicensing payments received by the Company. 


 




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2.3         Audit
Rights. EPIL shall have the right for a period of three years after each payment of Royalty Fees and/or Sublicense Fees
is made to EPIL to appoint at its expense an independent certified public accountant reasonably acceptable to the Company to audit
the relevant records of the Company to verify that the amounts of such Royalty Fees and/or Sublicense Fees were correctly determined.
Upon the request of EPIL, the Company shall, upon five days written notice from the Company and during regular business hours at
such place or places where such records are customarily kept, make its records available for audit by an independent certified
public accountant selected by EPIL to verify that such Royalty Fees and/or Sublicense Fees were correctly determined. Such audit
right shall not be exercised by EPIL more than once in any year and no period may be audited more than once. EPIL shall treat as
confidential information all such records made available for audit. The results of each audit, if any, shall be reported in writing
to the Company promptly (but in no event later than 30 days) after the audit and shall be binding on both EPIL and the Company.
EPIL shall bear the full cost of such audit unless such audit discloses an under-payment by the Company of more than 7.5% of the
relevant amount of royalties in any year, in which case the Company shall reimburse EPIL for all costs incurred by EPIL in connection
with such audit. In the event there is an under-payment to EPIL, the amount of such underpayment shall be paid to EPIL within five
business days of receiving a copy of the audit report. If the discrepancy is an over-payment to EPIL, the amount of such over-payment
shall be paid to EPIL within five business days of receiving a copy of the audit report.


 


ARTICLE
III


MISCELLANEOUS


 


3.1         Amendments.
This Deed may be amended, modified or supplemented only by a writing signed by each of the parties hereto.


 


3.2         Successors
and Assigns. Neither this Deed nor any of the rights or obligations hereunder shall be assigned by any of the parties without
the prior written consent of EPIL and Company; provided, however, that (a) either Party may assign any of its rights
and obligations hereunder to any of its Affiliates without consent so long as such Party remains fully responsible for all of its
obligations under this Deed, (b) the Company may assign or sell any of the Product Patents and/or Product Know-How to any Third
Party without consent so long as such Third Party agrees to assume and remain fully responsible for all of the obligations of the
Company under ARTICLE I and the Company shall remain liable for any failure by such Third Party to satisfy any obligation
set forth under ARTICLE I that would otherwise have been the obligation of the Company and (c) to the extent the Company
undergoes a change of control such that it is no longer a wholly-owned subsidiary of EPIL, the Company shall deliver to EPIL a
guaranty in favor of EPIL by a parent entity of sufficient creditworthiness in such form as is reasonably satisfactory to EPIL.
This Deed shall bind and inure to the benefit of the Company and EPIL and their respective successors and assigns.


 


3.3         Governing
Law; Jurisdiction. The Parties agree that this Deed shall be construed in accordance with and governed by New York law
without reference to the conflicts or choice of law principles thereof. Any litigation arising out of or relating to this Deed
shall be filed and pursued exclusively in the State or Federal courts in the Southern District of New York, and the Parties hereto
consent to the jurisdiction of and venue in such courts. Service of process upon any Party shall be deemed, in every respect, effective
upon such party if made by prepaid registered or certified mail, return receipt requested.


 




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3.4         Waiver
of Jury Trial. EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY THAT MAY ARISE UNDER THIS AGREEMENT OR THE OTHER
TRANSACTION DOCUMENTS IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH PARTY IRREVOCABLY AND UNCONDITIONALLY
WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE
OTHER DOCUMENTS ENTERED INTO IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.


 


3.5         Headings;
Definitions. The section and other headings contained in this Deed are for reference purposes only and shall not in any
way affect the meaning or interpretation of this Deed. Wherever in this Deed words indicating the plural number appear, such words
shall be considered as words indicating the singular number and vice versa where the context indicates the propriety of such use.


 


3.6         Counterparts.
This Deed may be executed in counterparts, each of which when so executed shall be deemed to be an original, and all such counterparts
shall together constitute but one and the same instrument. The Parties agree that the delivery of this Deed, and any other agreements
and documents at the Closing, may be effected by means of an exchange of facsimile or electronically transmitted signatures.


 


3.7         No
Third Party Beneficiaries. The terms and provisions of this Deed are intended solely for the benefit of the parties hereto
and their respective successors and permitted assigns, and it is not the intention of the parties to confer third-party beneficiary
rights, and this Deed does not confer any such rights, upon any other Person.


 


ARTICLE
IV


DEFINITIONS


 


4.1         Definitions.


 


“Affiliate”
means, with respect to any Person, any person directly or indirectly controlling or controlled by or under direct or indirect common
control with such Person (including without limitation its respective officers, directors and employees). For this purpose, “control”
means the power to direct the management and policies of a person through the ownership of securities, by contract or otherwise
and the terms “controlling” and “controlled” have meanings correlative to the foregoing.


 


“Business”
shall have the meaning set forth in the recitals of this Deed.


 


“Business
Day” means any day, other than Saturday, Sunday or any other day on which banks located in the State of New York are
authorized or required to close.


 


“Co-Promoter”
means a Third Party the Company contracts with to co-promote the Product.


 




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“Commercialization
Regulatory Approval” means, with respect to any Product, the regulatory approval required by applicable Laws to sell
such product in a country or region.


 


“First Commercial
Sale” means, with respect to any Product in any country in the world, the first sale, transfer or disposition for value
to an end-user of such Product in such country after receipt of Commercialization Regulatory Approval for such country. A sale
of the Product shall be deemed to occur on the earlier of (a) the date the Product is shipped to an end-user or (b) the date of
the invoice to the end-user of such Product.


 


“Fiscal Quarter”
means one of the four three-month accounting periods that comprise a fiscal year for Seller.


 


“GAAP”
means United States generally accepted accounting principles, consistently applied.


 


“Milestone
Events” means the events described in clauses (a), (b) and (c) of Section 1.1 and “Milestone Event”
means any one of such events.


 


“Milestone
Payment” means the consideration paid to EPIL in connection with a Milestone Event.


 


“Net Sales”
means the gross amount billed or invoiced by the Company or any of its Affiliates, or Co-Promoters to Third Parties throughout
all countries and territories of the world for sales or other dispositions or transfers for value of the Product less (a) reasonable
allowances for normal and customary trade (including those granted in core distribution agreements and inventory management agreements),
quantity and cash discounts on the Product actually allowed and taken (but excluding price discounts granted at the time of invoice
which are already reflected in the determination of the amount charged), (b) transportation, insurance and postage charges, if
paid by the Company or any Affiliate, or Co-Promoter of the Company (excluding amounts reimbursed by Third Party customers), (c)
credits, chargebacks, rebates or returns on the Product sold pursuant to agreements (including, without limitation, managed care
agreements) or government regulations, accounted for in accordance with GAAP, (d) any tax, tariff, customs duty, excise or other
duty or other governmental charge (other than a tax on income) levied on the sale, transportation or delivery of the Product and
actually paid by the Company, or any of its Affiliates or Co-Promoters and (e) amounts retained by Co-Promoters; provided none
of (a) through (e) shall be included in commercialization costs. In addition, Net Sales are subject to the following:


 


(i)          If
the Company or any of its Affiliates or Co-Promoters effects a sale, disposition or transfer of a Product to a customer in a particular
country other than on customary commercial terms or as part of a package of products and services, the Net Sales of such Product
to such customer shall be deemed to be “the fair market value” of such Product. For purposes of this subsection (i),
“fair market value” shall mean the value that would have been derived had such Product been sold as a separate product
to another customer in the country concerned on customary commercial terms.


 




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(ii)         In
the case of pharmacy incentive programs, hospital performance incentive program chargebacks, disease management programs, similar
programs or discounts on “bundles” of products, all discounts and the like shall be allocated among products on the
basis on which such discounts and the like were actually granted or, if such basis cannot be determined, in proportion to the respective
list prices of such products.


 


(iii)        For
purposes of clarity, use of any Product in clinical trials, pre-clinical studies or other research or development activities, or
disposal or transfer of the Products for a bona fide charitable purpose or purposes of a commercially reasonable sampling program
shall not give rise to any Net Sales.


 


“Product”
shall have the meaning set forth in the recitals of this Deed.


 


“Product Know-How”
means any and all rights related to the Product and /or the Product Patents, owned, licensed or controlled by the Company or its
Affiliates to include any scientific, pharmaceutical or technical information, data, discovery, invention (whether patentable or
not), know-how, substances, techniques, processes, systems, formulations, designs and expertise which is not generally known to
the public.


 


“Product Patents”
means any and all rights under any and all patent applications and/or patents anywhere in the world, now existing, currently pending
or hereafter filed or obtained or licensed by the Company or its Affiliates relating to the Product and any sub-divisions, divisions
or extensions of same.


 


“Royalty Fees”
means the payments described in Section 1.2.


 


“SEC”
means the Securities and Exchange Commission.


 


“Sublicense
Fees” means the payments described in Section 1.3.


 


“Tax”
or “Taxes” means any and all federal, state, local, or foreign net or gross income, gross receipts, net proceeds,
sales, use, ad valorem, value added, franchise, bank shares, withholding, payroll, employment, excise, property, abandoned property,
escheat, deed, stamp, alternative or add-on minimum, environmental, profits, windfall profits, transaction, license, lease, service,
service use, occupation, severance, energy, unemployment, social security, workers’ compensation, capital, premium, and other
taxes, assessments, customs, duties, fees, levies, or other governmental charges of any nature whatever, together with any interest,
penalties, additions to tax, or additional amounts with respect thereto.


 


“Territory”
means every country, territory, possession or other political subdivision of the world.


 


“Third Party”
means a Person other than the Company and EPIL and their respective Affiliates.


 


[Signature Page Follows]


 




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IN WITNESS WHEREOF, the parties have executed
this Deed as of the day and year first written above.


 


	 	EPIL
	 	 
	 	ELAN PHARMA INTERNATIONAL LIMITED
	 	 
	 	By: 	/s/ Mary Sheahan
	 	Name: Mary Sheahan
	 	Title:  
	 	 
	 	By:  	/s/ William F. Daniel
	 	Name: William F. Daniel
	 	Title:  


 


	 	COMPANY:
	 	 
	 	ELAN SCIENCE TEN LIMITED
	 	 
	 	By:  	/s/ Mary Sheahan
	 	Name: Mary Sheahan
	 	Title:  
	 	 
	 	By:  	/s/ William F. Daniel
	 	Name: William F. Daniel
	 	Title:  


 


[Signature Page to Milestone, Royalty and
Sublicensing Deed]