Exhibit 10.30

 

Portions of this exhibit marked [*] are requested to be treated confidentially.

 

SECOND AMENDED AND RESTATED

LOAN AND SECURITY AGREEMENT

 

THIS SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (this “Agreement”),
dated as of September 30, 2013 (the “Second Restatement Date”) by and among
MIDCAP FUNDING III, LLC, a Delaware limited liability company, with an office
located at 7255 Woodmont Avenue, Suite 200, Bethesda, Maryland 20814 (“MidCap”),
as administrative agent (“Agent”), the Lenders listed on Schedule 1 hereto and
otherwise party hereto from time to time (each a “Lender”, and collectively the
“Lenders”), and Furiex Pharmaceuticals, Inc., a Delaware corporation, APBI
HOLDINGS, LLC, a North Carolina limited liability company, DEVELOPMENT PARTNERS,
LLC, a Delaware limited liability company, and GENUPRO, INC., a North Carolina
corporation (either individually or collectively as the context may require, the
“Borrower”), provides the terms on which Lenders agree to lend to Borrower and
Borrower shall repay Lenders.

 

RECITALS

 

MidCap, the Borrower and the Lenders party thereto (the “2011 Lenders”) were
party to that certain Loan and Security Agreement, dated as of August 18, 2011
(the “2011 Closing Date”) by and among MidCap, as Agent (the “2011 Agent”),
Borrower and the 2011 Lenders (as amended, restated, supplemented or otherwise
modified from time to time prior to the Restatement Date (as defined below), the
“2011 Loan Agreement”), which 2011 Loan Agreement was amended and restated in
its entirety by that certain Amended and Restated Loan and Security Agreement,
dated as of August 2, 2012 (the “Restatement Date”) by and among MidCap, as
Agent (the “Restatement Agent”), Borrower and the Lenders party thereto (the
“Restatement Lenders”)(as amended, restated, supplemented or otherwise modified
from time to time, the “Restatement Loan Agreement”), and the Restatement Agent,
the Borrower and the Restatement Lenders wish to amend and restate the
Restatement Loan Agreement in its entirety with this Agreement, it being their
intention that this Second Amended and Restated Loan Agreement and the execution
and the delivery of the promissory notes and other documents or agreements
executed in connection herewith shall not be a novation of the “Term Loan’ or
“Term Loans’ (as such terms are defined in the 2011 Loan Agreement and the
Restatement Loan Agreement, as applicable, and as used herein, collectively, the
“Restatement Term Loan”) and “Obligations’ (as defined in the 2011 Loan
Agreement and the Restatement Loan Agreement, as applicable, and as used herein,
including, without limitation, the Restatement Term Loan, collectively, the
“Restatement Obligations”) of the Borrower or any Loan Party pursuant to the
Restatement Loan Agreement and the “Loan Documents’ (as such terms are defined
in the 2011 Loan Agreement and the Restatement Loan Agreement, as applicable and
as used herein, the “Restatement Loan Documents”), but shall merely restate and,
where applicable, amend or modify the terms of such Restatement Obligations, so
that the Obligations (as hereinafter defined) represent, among other things, the
amendment, restatement, renewal, extension and modification of the Restatement
Obligations and the Loan Documents (as hereinafter defined) shall restructure,
restate, renew, extend, amend and modify the Restatement Loan Agreement and the
other Restatement Loan Documents executed in connection therewith.

 

 

 
 

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In consideration of the premises and the covenants and agreements contained
herein, the parties hereto agree as follows:

 

1.     ACCOUNTING AND OTHER TERMS

 

Accounting terms not defined in this Agreement shall be construed in accordance
with GAAP. Calculations and determinations must be made in accordance with GAAP.
Capitalized terms not otherwise defined in this Agreement shall have the
meanings set forth in Section 14. All other terms contained in this Agreement,
unless otherwise indicated, shall have the meaning provided by the Code to the
extent such terms are defined therein.

 

2.     LOAN AND TERMS OF PAYMENT

 

2.1     Promise to Pay. Borrower hereby unconditionally promises to pay to each
Lender in accordance with its respective Pro Rata Share, the outstanding
principal amount of all Credit Extensions made by the Lenders, and accrued and
unpaid interest thereon, and any other amounts due hereunder as and when due in
accordance with this Agreement.

 

2.2     Term Loan.

 

(a)     Availability. Subject to the terms and conditions of this Agreement, the
Lenders agree, severally and not jointly, to make a term loan to Borrower in an
aggregate amount up to FORTY-TWO MILLION AND NO/100 Dollars ($42,000,000.00)
according to each Lender’s Term Loan Commitment as set forth on Schedule 1
hereto (the “Term Loan”). After repayment, the Term Loan may not be re-borrowed.
As of the Second Restatement Date, $37,837,837.76 of the Restatement Term Loan
outstanding under the Restatement Loan Agreement shall constitute part of the
Term Loan funded pursuant to and under this Agreement and shall constitute a
portion of the Obligations. On the Second Restatement Date, the Restatement Term
Loan shall be deemed assigned by the Restatement Lenders to the Lenders
hereunder as of the Second Restatement Date in accordance with each Lender's Pro
Rata Share and in accordance with (i) Term Loan Commitment allocations as set
forth on Schedule 1 hereto and (ii) Section 12.15.

 

(b)     Interest Payments and Repayment. Commencing on the first (1st) Interest
Payment Date following the Second Restatement Date and continuing on the
Interest Payment Date of each successive month thereafter through and including
the Maturity Date, Borrower shall make monthly payments of interest to each
Lender in accordance with its respective Pro Rata Share, in arrears, and
calculated as set forth in Section 2.3. Commencing on the Amortization Date, and
continuing on each successive Amortization Payment Date thereafter through and
including the Maturity Date, Borrower shall make consecutive scheduled payments
of principal to each Lender in accordance with its respective Pro Rata Share, as
calculated by Agent based upon: (i) the amount of such Lender’s Term Loan and
(ii) the amortization schedule set forth as Schedule 2.2(b) hereto. All unpaid
principal and accrued interest with respect to the Term Loan is due and payable
in full on the Maturity Date. The Term Loan may be prepaid only in accordance
with Sections 2.2(c) and 2.2(d).

 

(c)     Mandatory Prepayments. If the Term Loan is accelerated following the
occurrence of an Event of Default, Borrower shall immediately pay to each Lender
in accordance with its respective Pro Rata Share, an amount equal to the sum of:
(i) all outstanding principal of the Term Loan and all other Obligations, and
all accrued and unpaid interest thereon, plus (ii) the Final Payment, plus (iii)
the Prepayment Fee, plus (iv) all other sums that shall have become due and
payable, including Lenders’ Expenses.

 

 

 
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(d)      Permitted Prepayment of Loans. Borrower shall have the option to prepay
all, but not less than all, of the Term Loan advanced by the Lenders under this
Agreement; provided, however, that Borrower (i) provides written notice to Agent
of its election to prepay the Term Loan at least ten (10) days prior to such
prepayment, and (ii) pays to each Lender in accordance with its respective Pro
Rata Share, on the date of such prepayment, an amount equal to the sum of:
(A) all outstanding principal of the Term Loan and all other Obligations, and
all accrued interest thereon, plus (B) the Final Payment, plus (C) the
Prepayment Fee, plus (D) all other sums that shall have become due and payable,
including Lenders’ Expenses.

 

2.3     Payment of Interest on the Credit Extensions.

 

(a)     Computation of Interest. Interest on the Credit Extensions and all fees
payable hereunder shall be computed on the basis of a 360-day year and the
actual number of days elapsed in the period during which such interest accrues.
In computing interest on any Credit Extension, the date of the making of such
Credit Extension shall be included and the date of payment shall be excluded;
provided, however, that if any Credit Extension is repaid on the same day on
which it is made, such day shall be included in computing interest on such
Credit Extension.

 

(b)     Interest Rate Determination. Subject to the provisions of Section 2.3(c)
below, the Term Loan shall bear interest at a fixed rate on the outstanding
principal amount thereof from the Funding Date for the Term Loan until paid in
full at a rate per annum equal to ten percent (10%).

 

(c)     Default Rate. Upon the occurrence and during the continuance of an Event
of Default, at the election of the Agent or Required Lenders, Obligations shall
bear interest at a rate per annum that is four percent (4.0%) above the rate
that is otherwise applicable thereto (the “Default Rate”). Any such election to
apply the Default Rate by Agent or Required Lenders may, in Agent’s or Required
Lenders’ sole discretion, become effective retroactively as of the date of such
Event of Default having occurred. Payment or acceptance of the increased
interest rate provided in this Section 2.3(c) is not a permitted alternative to
timely payment and shall not constitute a waiver of any Event of Default or
otherwise prejudice or limit any rights or remedies of Agent or Lenders.

 

(d)     Debit of Accounts. Any Lender may debit (or ACH) any of Borrower’s
Deposit Accounts, including the Designated Deposit Account, for principal and
interest payments when due or any other amounts Borrower owes the Lenders under
the Loan Documents when due. These debits (or ACH activity) shall not constitute
a set-off.

 

(e)     Payments. Payments of principal and/or interest received after 12:00
Noon Eastern Time are considered received at the opening of business on the next
Business Day. When a payment is due on a day that is not a Business Day, the
payment is due the next Business Day and additional fees or interest, as
applicable, shall continue to accrue until paid. All payments to be made by
Borrower hereunder or under any other Loan Document, including payments of
principal and interest made hereunder and pursuant to any other Loan Document,
and all fees, expenses, indemnities and reimbursements, shall be made without
set-off, recoupment or counterclaim, in lawful money of the United States and in
immediately available funds. All payments required under this Agreement are to
be made directly to Agent unless otherwise directed by Agent in writing.

 

 

 
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(f)     Maximum Lawful Rate. In no event shall the interest charged hereunder,
with respect to the Term Loan and corresponding promissory notes (if any) or any
other obligations of Borrower under any of the Loan Documents exceed the maximum
amount permitted under the Laws of the State of Maryland. Notwithstanding
anything to the contrary herein or elsewhere, if at any time the rate of
interest payable hereunder or under any promissory note or other Loan Document
(the “Stated Rate”) would exceed the highest rate of interest permitted under
any applicable Law to be charged (the “Maximum Lawful Rate”), then for so long
as the Maximum Lawful Rate would be so exceeded, the rate of interest payable
shall be equal to the Maximum Lawful Rate; provided, however, that if at any
time thereafter the Stated Rate is less than the Maximum Lawful Rate, Borrower
shall, to the extent permitted by Law, continue to pay interest at the Maximum
Lawful Rate until such time as the total interest received is equal to the total
interest which would have been received had the Stated Rate been (but for the
operation of this provision) the interest rate payable. Thereafter, the interest
rate payable shall be the Stated Rate unless and until the Stated Rate again
would exceed the Maximum Lawful Rate, in which event this provision shall again
apply. In no event shall the total interest received by any Lender exceed the
amount which it could lawfully have received, had the interest been calculated
for the full term hereof at the Maximum Lawful Rate. If, notwithstanding the
prior sentence, any Lender has received interest hereunder in excess of the
Maximum Lawful Rate, then such excess amount shall be applied to the reduction
of the principal balance of such Lender’s Term Loan or to other amounts (other
than interest) payable hereunder, and if no such principal or other amounts are
then outstanding, such excess or part thereof remaining shall be paid to
Borrower. In computing interest payable with reference to the Maximum Lawful
Rate applicable to any Lender, such interest shall be calculated at a daily rate
equal to the Maximum Lawful Rate divided by the number of days in the year in
which such calculation is made.

 

2.4     Fees and Expenses. Borrower shall pay the following fees and expenses:

 

(a)     Fees under Fee Letter. The fees payable by Borrower pursuant to the Fee
Letter to the persons identified therein;

 

(b)     Final Payment. The Final Payment, when due under Section 2.2(c) or
2.2(d), or otherwise on the Maturity Date, to each Lender, in accordance with
its respective Pro Rata Share;

 

(c)     Prepayment Fee. The Prepayment Fee, if and when due under Section 2.2(c)
or 2.2(d), to each Lender, in accordance with its respective Pro Rata Share
immediately prior to application of the corresponding prepayment; and

 

 

 
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(d)     Lenders’ Expenses. All of Lenders’ Expenses incurred through and after
the Second Restatement Date, when due (and in the absence of any other due date
specified herein, such Lenders’ Expenses shall be due upon demand).

 

2.5     Additional Costs. If any new Law or regulation increases a Lender’s
costs or reduces its income for the Term Loan, Borrower shall pay the increase
in cost or reduction in income or additional expense; provided, however, that
Borrower shall not be liable for any amount attributable to any period before
one hundred eighty (180) days prior to the date such Lender notifies Borrower of
such increased costs. Each Lender agrees that it shall allocate any increased
costs among its customers similarly affected in good faith and in a manner
consistent with such Lender’s customary practice.

 

2.6     Payments and Taxes. Any and all payments made by Borrower under this
Agreement or any other Loan Document shall be made free and clear of and without
deduction for any and all present or future taxes, levies, imposts, duties,
deductions, withholdings, assessments, fees or other charges imposed by any
Governmental Authority (including any interest, additions to tax or penalties
applicable thereto) other than any taxes imposed on or measured by any Lender’s
overall net income and franchise taxes imposed on it (in lieu of net income
taxes), by a jurisdiction (or any political subdivision thereof) as a result of
any Lender being organized or resident, conducting business (other than a
business deemed to arise from such Lender having executed, delivered or
performed its obligations or received a payment under, or enforced, or otherwise
with respect to, this Agreement or any other Loan Document) or having its
principal office in such jurisdiction (“Indemnified Taxes”). If any Indemnified
Taxes shall be required by Law to be withheld or deducted from or in respect of
any sum payable under this Agreement or any other Loan Document to any Lender,
(a) an additional amount shall be payable as may be necessary so that, after
making all required withholdings or deductions (including withholdings or
deductions applicable to additional sums payable under this Section) such Lender
receives an amount equal to the sum it would have received had no such
withholdings or deductions been made, (b) Borrower shall make such withholdings
or deductions, (c) Borrower shall pay the full amount withheld or deducted to
the relevant taxing authority or other authority in accordance with applicable
Law, and (d) Borrower shall deliver to such Lender evidence of such payment.
Borrower’s obligation hereunder shall survive the termination of this Agreement.

 

2.7     Secured Promissory Notes. The Term Loan shall be evidenced by one or
more Secured Promissory Note(s) in substantially the form attached as Exhibit D
hereto (or an amended and restated version thereto in form and substance
satisfactory to Agent) (each a “Secured Promissory Note”), and shall be
repayable as set forth herein. Borrower irrevocably authorizes each Lender to
make or cause to be made, on or about the Funding Date of the Term Loan or at
the time of receipt of any payment of principal on such Lender’s Secured
Promissory Note, an appropriate notation on such Lender’s Secured Promissory
Note Record reflecting the making of such Term Loan or (as the case may be) the
receipt of such payment. The outstanding amount of the Term Loan set forth on
such Lender’s Secured Promissory Note Record shall be prima facie evidence of
the principal amount thereof owing and unpaid to such Lender, but the failure to
record, or any error in so recording, any such amount on such Lender’s Secured
Promissory Note Record shall not limit or otherwise affect the obligations of
Borrower hereunder or under any Secured Promissory Note to make payments of
principal of or interest on any Secured Promissory Note when due. Upon receipt
of an affidavit of an officer of a Lender as to the loss, theft, destruction, or
mutilation of its Secured Promissory Note, Borrower shall issue, in lieu
thereof, a replacement Secured Promissory Note in the same principal amount
thereof and of like tenor.

 

 

 
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3.     CONDITIONS OF LOANS

 

3.1     Conditions Precedent to the Initial Credit Extension. Each Lender’s
obligation to fund its Term Loan Commitment is subject to the condition
precedent that Agent shall consent to or shall have received, in form and
substance satisfactory to Agent and Lenders, such documents, and completion of
such other matters, as Agent may reasonably deem necessary or appropriate,
including, without limitation:

 

(a)     duly executed original signatures to this Agreement, the Second Global
Reaffirmation Agreement, the Fee Letter and the other Loan Documents to which
Borrower is a party;

 

(b)     duly executed original Secured Promissory Notes in favor of each Lender
with a face amount equal to such Lender’s Term Loan Commitment;

 

(c)     the formation documents of Borrower certified by the Secretary of State
of the state of organization of Borrower as of a date no earlier than thirty
(30) days prior to the Second Restatement Date;

 

(d)     good standing certificates dated as of a date no earlier than thirty
(30) days prior to the Second Restatement Date from each Borrower’s state of
organization and each state in which the nature of Borrower’s business requires
it to be qualified to transact business;

 

(e)     a duly executed original Secretary’s Certificate dated as of the Second
Restatement Date which includes copies of the completed Borrowing Resolutions
for Borrower;

 

(f)     certified copies, dated as of a recent date, of financing statement
searches, as Agent shall request, accompanied by written evidence (including any
UCC termination statements) that the Liens indicated in any such financing
statements either constitute Permitted Liens or have been or, in connection with
the funding of the Term Loan, will be terminated or released;

 

(g)     a legal opinion of Borrower’s counsel dated as of the Second Restatement
Date together with the duly executed original signatures thereto;

 

(h)     evidence satisfactory to Agent that the insurance policies required by
Section 6.5 hereof are in full force and effect, together with appropriate
evidence showing loss payable and/or additional insured clauses or endorsements
in favor of Agent, for the ratable benefit of Lenders;

 

(i)     payment of the fees due and owing under the Fee Letter and the Lenders’
Expenses described in Section 2.4(d);

 

 

 
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(j)     timely receipt by the Agent of an executed disbursement letter;

 

(k)     the representations and warranties in Section 5 shall be true, correct
and complete in all respects on the Second Restatement Date; provided, however,
that those representations and warranties expressly referring to a specific date
shall be true, accurate and complete in all respects as of such date, and no
Default or Event of Default shall have occurred and be continuing or result from
the making of the Term Loan. The making of the Term Loan shall constitute
Borrower’s representation, warranty and confirmation that the conditions set
forth in this clause (m) have been satisfied;

 

(l)     the Subordination Agreement, duly executed by Subordinated Lender and
Borrower in favor of the Lenders;

 

(m)     evidence that Borrower has received the cash proceeds of the issuance of
the Subordinated Debt in an original principal amount equal to Fifteen Million
and No/100 Dollars ($15,000,000.00) net of reasonable and customary transaction
expenses satisfactory to Agent; and

 

(n)     in such Lender’s sole discretion, there has not been any Material
Adverse Change or any material impairment in the general affairs, management,
results of operation, financial condition or the prospect of repayment of the
Obligations, or any material adverse deviation by Borrower from the most recent
business plan of Borrower presented to and accepted by Agent.

 

3.2     Covenant to Deliver. Borrower agrees to deliver to Agent each item
required to be delivered to Agent under this Agreement as a condition precedent
to any Credit Extension. Borrower expressly agrees that a Credit Extension made
prior to the receipt by Agent of any such item shall not constitute a waiver by
the Lenders of Borrower’s obligation to deliver such item, and any such Credit
Extension in the absence of a required item shall be made in Agent’s sole
discretion.

 

4.     CREATION OF SECURITY INTEREST

 

4.1     Grant of Security Interest. Borrower hereby grants to Agent, for the
ratable benefit of the Lenders, to secure the payment and performance in full of
all of the Obligations, a continuing security interest in, and pledges to Agent,
for the ratable benefit of the Lenders, the Collateral, wherever located,
whether now owned or hereafter acquired or arising, and all proceeds and
products thereof. Borrower represents, warrants, and covenants that the security
interest granted herein is and shall at all times continue to be a first
priority perfected security interest in the Collateral, subject only to
Permitted Liens that may have priority by operation of applicable Law. If
Borrower shall acquire a commercial tort claim (as defined in the Code),
Borrower shall promptly notify Agent in a writing signed by Borrower of the
general details thereof (and further details as may be reasonably required by
Agent) and grant to Agent, for the ratable benefit of the Lenders, in such
writing a security interest therein and in the proceeds thereof, all upon the
terms of this Agreement, with such writing to be in form and substance
reasonably satisfactory to Agent.

 

4.2     Authorization to File Financing Statements. Borrower hereby authorizes
Agent to file financing statements, without notice to Borrower, with all
appropriate jurisdictions to perfect or protect Agent’s and each Lender’s
interest or rights hereunder, including a notice that any disposition of the
Collateral not permitted hereunder, by either Borrower or any other Person,
shall be deemed to violate the rights of Agent and the Lenders under the Code.

 

 

 
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5.     REPRESENTATIONS AND WARRANTIES

 

Borrower represents and warrants as follows at all times unless expressly
provided below:

 

5.1     Due Organization, Authorization: Power and Authority.

 

(a)     Borrower and each of its Subsidiaries are duly existing and in good
standing, as Registered Organizations in their respective jurisdictions of
formation and are qualified and licensed to do business and are in good standing
in any jurisdiction in which the conduct of their business or their ownership of
property requires that they be qualified except where the failure to be so
qualified could not reasonably be expected to result in a Material Adverse
Change. Borrower represents and warrants that (i) Borrower’s exact legal name is
that indicated on Schedule 5.1 and on the signature page hereof; (ii) Borrower
is an organization of the type and is organized in the jurisdiction set forth on
Schedule 5.1; (iii) Schedule 5.1 accurately sets forth Borrower’s organizational
identification number or accurately states that Borrower has none; (iv) Schedule
5.1 accurately sets forth Borrower’s place of business, or, if more than one,
its chief executive office as well as Borrower’s mailing address (if different
than its chief executive office); and (v) Borrower has not, in the past five (5)
years, changed its jurisdiction of formation, organizational structure or type,
or any organizational number assigned by its jurisdiction. Further, in
connection with the 2011 Loan Agreement, Borrower delivered to Agent a completed
Perfection Certificate signed by Borrower (the “Perfection Certificate”). All
information set forth on the Perfection Certificate pertaining to Borrower and
each of its Subsidiaries is accurate and complete as of the Second Restatement
Date other than with respect to changes that are reflected in the Schedules
attached to this Agreement (it being understood and agreed that Borrower may
from time to time update certain information in the Perfection Certificate after
the Second Restatement Date, to the extent permitted by one or more specific
provisions in this Agreement).

 

(b)     The execution, delivery and performance by Borrower of the Loan
Documents to which it is a party have been duly authorized, and do not (i)
conflict with any of Borrower’s Operating Documents; (ii) contravene, conflict
with, constitute a default under or violate any material Requirement of Law;
(iii) contravene, conflict or violate any applicable order, writ, judgment,
injunction, decree, determination or award of any Governmental Authority by
which Borrower or any of its Subsidiaries or any of their property or assets may
be bound or affected; (iv) require any action by, filing, registration, or
qualification with, or Governmental Approval from, any Governmental Authority
(except such Governmental Approvals which have already been obtained and are in
full force and effect); or (v) constitute an event of default under any material
agreement by which Borrower or any of its Subsidiaries or their respective
properties is bound. Borrower is not in default under any agreement to which it
is a party or by which it is bound in which the default could reasonably be
expected to have a Material Adverse Change.

 

 
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5.2     Collateral.

 

(a)     Collateral Accounts. Borrower has good title to, has rights in, and has
the power to grant a security interest in and transfer each item of the
Collateral upon which it purports to grant a Lien hereunder, free and clear of
any and all Liens, except Permitted Liens. Borrower has no Deposit Accounts,
Securities Accounts, Commodity Accounts or other investment accounts other than
the Collateral Accounts with the banks and/or financial institutions listed on
Schedule 5.2(a), for which Borrower has given Agent notice and taken such
actions as are necessary to grant to Agent, for the ratable benefit of Lenders,
a perfected security interest therein.

 

(b)     Accounts. The Accounts are bona fide, existing obligations of the
Account Debtors.

 

(c)     Inventory. All Sale Inventory is in all material respects of good and
marketable quality, free from material defects. All Development Inventory
manufactured for use in and/or used in clinical trials has been synthesized in
accordance with current “Good Manufacturing Practices’ making it suitable for
use in humans.

 

(d)     Intellectual Property and License Agreements. A list of all of
Borrower’s copyrights, copyright applications, trademarks, trademark
applications, patents and patent applications (“Subject Intellectual Property”)
and all license agreements (including all in-bound license agreements, but
excluding over-the-counter software that is commercially available to the
public) is set forth on Schedule 5.2(d), which indicates, for each item of
property: (i) the name of Borrower owning such Subject Intellectual Property or
licensee to such license agreement; (ii) Borrower’s identifier for such property
(i.e., name of patent, license, etc.), (iii) whether such property is Subject
Intellectual Property (or application therefor) owned by Borrower or is property
to which Borrower has rights pursuant to a license agreement, and (iv) the
expiration date of such Subject Intellectual Property or license agreement. In
the case of any license agreement, Schedule 5.2(d) further indicates, for each:
(A) the name and address of the licensor, (B) the name and date of the license
agreement pursuant to which Intellectual Property is licensed, (C) whether or
not such license agreement grants an exclusive license to Borrower, and (D)
whether there are any restrictions in such license agreement as to the ability
of Borrower to grant a security interest in and/or to transfer any of its rights
as a licensee under such license agreement. Except as noted on Schedule 5.2(d),
Borrower is the sole owner of its Subject Intellectual Property, except for
non-exclusive licenses granted to its customers in the Ordinary Course of
Business. Except as noted on Schedule 5.2(d), each Patent is properly filed and
maintained, no part of the Subject Intellectual Property has been judged invalid
or unenforceable, in whole or in part, and to the best of Borrower’s knowledge
(x) no claim has been made that any part of the Subject Intellectual Property
violates the rights of any third party, except to the extent such claim could
not reasonably be expected to result in a Material Adverse Change and (y) each
Patent is valid and enforceable.

 

 

 
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(e)     Location of Collateral. On the Second Restatement Date, the Collateral,
exclusive of Development Inventory, is located at the address(es) identified on
Schedule 5.2(e), and is not in the possession of any third party bailee (such as
a warehouse) except as disclosed Schedule 5.2(e), and as of the Second
Restatement Date, no such third party bailee possesses components of the
Collateral, exclusive of Development Inventory, in excess of [*] Dollars ($[*])
or which constitutes Borrowers’ Books. None of the components of the Collateral,
other than Development Inventory, shall be maintained at locations other than as
disclosed Schedule 5.2(e) on the Second Restatement Date or as permitted
pursuant to Section 7.2. In the event that Borrower, after the Second
Restatement Date, intends to store or otherwise deliver any portion of the
Collateral, other than Development Inventory, to a bailee in excess of [*]
Dollars ($[*]) or which constitutes Borrowers’ Books, then Borrower will first
receive the written consent of Agent and such bailee must execute and deliver a
bailee agreement in form and substance satisfactory to Agent in its sole
discretion. Without limiting the foregoing, in the event that (x) PPD is in
default under its lease for the premises located at 3900 Paramount Parkway,
Suite 150, Morrisville, North Carolina 27560 or (y) such lease is terminated and
Borrower enters into a new or separate lease with the owner of such premises or
if the owner confirms Borrower’s sublease shall remain in effect, then in either
case of (x) or (y), upon the request of Agent, Borrower shall obtain an Access
Agreement executed by such owner and by Borrower in favor of Agent.

 

5.3     Litigation. Except for routine proceedings (which shall not include any
enforcement action or other adverse proceedings) with the FDA or other similar
regulatory agencies, or as otherwise disclosed on Schedule 5.3 hereto, there are
no actions or proceedings pending or, to the knowledge of the Responsible
Officers, threatened in writing by or against Borrower or any of its
Subsidiaries involving more than [*] Dollars ($[*]).

 

5.4     No Material Deterioration in Financial Condition; Financial Statements.
All consolidated financial statements for Borrower and any of its Subsidiaries
delivered to Agent fairly present, in conformity with GAAP, in all material
respects Borrower’s consolidated financial condition and Borrower’s consolidated
results of operations; provided, however, that (i) the interim financial
statements of Borrower lack footnotes and are subject to year-end audit
adjustments, all in accordance with GAAP and (ii) any forward-looking forecasts
included in such financial statements are not in conformity with GAAP and may
differ from the actual results for any period for which such forecasts have been
provided, but in any event represent the Borrower’s good faith estimate of
future financial performance and are based on assumptions believed by the
Borrower to be fair and reasonable in light of current market conditions. There
has not been any material deterioration in Borrower’s consolidated financial
condition since the date of the most recent financial statements and projections
submitted to Agent.

 

5.5     Solvency. The fair salable value of Borrower’s assets (including
goodwill minus disposition costs) exceeds the fair value of its liabilities.
After giving effect to the transactions described in this Agreement and the
Subordinated Debt Documents, (a) Borrower is not left with unreasonably small
capital in relation to its business as presently conducted, and (b) Borrower is
able to pay its debts (including trade debts) as they mature.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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5.6     Regulatory Compliance.

 

(a)     Borrower is not an “investment company” or a company “controlled” by an
“investment company” under the Investment Company Act of 1940, as amended.
Borrower is not engaged as one of its important activities in extending credit
for margin stock (under Regulations X, T and U of the Federal Reserve Board of
Governors). Borrower has complied in all material respects with the Federal Fair
Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding
company” or an “affiliate” of a “holding company” or a “subsidiary company” of a
“holding company”, as each term is defined and used in the Public Utility
Holding Company Act of 2005. Borrower has not violated any Laws, ordinances or
rules, the violation of which could reasonably be expected to have a Material
Adverse Change. None of Borrower’s or any of its Subsidiaries’ properties or
assets has been used by Borrower or any Subsidiary or, to Borrower’s knowledge,
by previous Persons, in disposing, producing, storing, treating, or transporting
any hazardous substance other than in material compliance with applicable Laws.
Borrower has obtained all Required Permits, or has contracted with third parties
holding Required Permits, necessary for compliance with all Laws and all such
Required Permits are current. Borrower and each of its Subsidiaries have
obtained all consents, approvals and authorizations of, made all declarations or
filings with, and given all notices to, all Governmental Authorities that are
necessary to continue their respective businesses as currently conducted.

 

(b)     None of the Borrower, its Affiliates or any of their respective agents
acting or benefiting in any capacity in connection with the transactions
contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law,
(ii) engages in or conspires to engage in any transaction that evades or avoids,
or has the purpose of evading or avoiding or attempts to violate, any of the
prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person.
Neither Borrower nor, to the knowledge of Borrower, any of its Affiliates or
agents acting or benefiting in any capacity in connection with the transactions
contemplated by this Agreement, (x) conducts any business or engages in making
or receiving any contribution of funds, goods or services to or for the benefit
of any Blocked Person, or (y) deals in, or otherwise engages in any transaction
relating to, any property or interest in property blocked pursuant to Executive
Order No. 13224, any similar executive order or other Anti-Terrorism Law.

 

5.7     Subsidiaries; Investments. Borrower does not own any stock, partnership
interest or other equity securities, except for Permitted Investments.

 

5.8     Tax Returns and Payments; Pension Contributions. Borrower has timely
filed all required tax returns and reports, and Borrower and its Subsidiaries
have timely paid all foreign, federal, state and local taxes, assessments,
deposits and contributions owed by Borrower, except that Borrower may defer
payment of any contested taxes so long as Borrower (a) in good faith contests
its obligation to pay such taxes by appropriate proceedings promptly and
diligently instituted and conducted, (b) notifies Agent in writing of the
commencement of, and any material development in, the proceedings, and (c) posts
bonds or takes any other steps required to prevent the Governmental Authority
levying such contested taxes from obtaining a Lien upon any of the Collateral
that is other than a “Permitted Lien”. Borrower is unaware of any claims or
adjustments proposed for any of Borrower’s prior tax years which could result in
additional taxes becoming due and payable by Borrower. Borrower has paid all
amounts required to fund all of its present pension, profit sharing and deferred
compensation plans in accordance with their terms, and Borrower has not
withdrawn from participation in, and has not permitted partial or complete
termination of, or permitted the occurrence of any other event with respect to,
any such plan which could reasonably be expected to result in any liability of
Borrower, including any liability to the Pension Benefit Guaranty Corporation or
its successors or any other governmental agency.

 

 

 
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5.9     Use of Proceeds. Borrower shall use the proceeds of the Credit
Extensions solely as working capital and to fund its general business
requirements, and not for personal, family, household or agricultural purposes.

 

5.10     Full Disclosure. No written representation, warranty or other statement
of Borrower in any certificate or written statement given to Agent or any
Lender, as of the date such representation, warranty, or other statement was
made, taken together with all such written certificates and written statements
given to Agent or any Lender, contains any untrue statement of a material fact
or omits to state a material fact necessary to make the statements contained in
the certificates or statements not misleading (it being recognized that the
projections and forecasts provided by Borrower in good faith and based upon
reasonable assumptions are not viewed as facts and that actual results during
the period or periods covered by such projections and forecasts may differ from
the projected or forecasted results).

 

5.11     Regulatory Developments.

 

(a)     All Products and all Required Permits are listed on Schedule 5.11 (as
updated from time to time pursuant to Section 6.2(e)), and Borrower has
delivered to Agent a copy of all Required Permits as of the date hereof and to
the extent requested by Agent pursuant to Section 6.2(e).

 

(b)     Without limiting the generality of Section 5.6 above, with respect to
any Development Compound or Sale Compound of Borrower, Borrower has received and
such Product is the subject of, all Required Permits needed in connection with
the testing and/or manufacture, as applicable, with respect to such Product as
such testing is currently being conducted by or on behalf of Borrower with
respect to Development Compounds or Sale Compounds, and Borrower has not
received any notice from any applicable Governmental Authority, specifically
including the FDA, that such Governmental Authority is conducting an
investigation or review of (i) Borrower’s manufacturing facilities and processes
for any Sale Compound which have disclosed any material deficiencies or
violations of Laws and/or the Required Permits related to the manufacture of
such Sale Compound, or (ii) any such Required Permit or that any such Required
Permit has been revoked or withdrawn, nor has any such Governmental Authority
issued any order or recommendation stating that the testing of such Development
Compound or manufacturing of such Sale Compound by Borrower should cease.

 

(c)     Without limiting the generality of Section 5.6 above, with respect to
any Sale Compound that may be marketed or sold by Borrower, Borrower has
received, and such Sale Compound is the subject of, all Required Permits needed
in connection with the marketing and sales of such Sale Compound that may be
marketed or sold by Borrower, and Borrower has not received any notice from any
applicable Governmental Authority, specifically including the FDA, that such
Governmental Authority is conducting an investigation or review of any such
Required Permit or approval or that any such Required Permit has been revoked or
withdrawn, nor has any such Governmental Authority issued any order or
recommendation stating that such marketing or sales of such Sale Compound cease
or that such Sale Compound be withdrawn from the marketplace.

 

 

 
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(d)     Without limiting the generality of Section 5.6 above, there have been no
serious adverse clinical test results related to the safety or efficacy of
Development Compounds resulting in the termination of all clinical studies for
such Development Compound or recalls of Sale Compounds (whether voluntary or
involuntary), in each case which have resulted in or could reasonably be
expected to result in a Material Adverse Change.

 

(e)     Borrower has not experienced any material failures in its manufacturing
of any Sale Compound such that the amount of such Sale Compound successfully
manufactured by Borrower in accordance with all specifications thereof and the
required payments related thereto in any month shall decrease significantly with
respect to the quantities of such Sale Compound produced in the prior month,
which such decrease has resulted in or could reasonably be expected to result in
a Material Adverse Change.

 

6.     AFFIRMATIVE COVENANTS

 

Borrower covenants and agrees to do all of the following:

 

6.1     Organization and Existence; Government Compliance.

 

(a)     Maintain its and all its Subsidiaries’ legal existence and good standing
in their respective jurisdictions of formation and maintain qualification in
each jurisdiction in which the failure to so qualify could reasonably be
expected to result in a Material Adverse Change. Borrower shall comply, and have
each Subsidiary comply, with all Laws, ordinances and regulations to which it is
subject, the noncompliance with which could reasonably be expected to result in
a Material Adverse Change.

 

(b)     Obtain and keep in full force and effect, all of the Governmental
Approvals, if any, necessary for the performance by Borrower of its obligations
under the Loan Documents to which it is a party and the grant of a security
interest to Agent for the ratable benefit of the Lenders, in all of the
Collateral. Borrower shall promptly provide copies of any such obtained
Governmental Approvals to Agent.

 

(c)     In connection with the testing of each Development Compound or the
manufacture, marketing or sale of each and any Sale Compound by Borrower,
Borrower shall comply fully and completely in all respects with all Required
Permits at all times issued by any Governmental Authority the noncompliance with
which could reasonably be expected to result in a Material Adverse Change,
specifically including the FDA, with respect to such testing of any Development
Compound or such manufacture, marketing or sales of any Sale Compound by
Borrower as such activities are at any such time being conducted by Borrower.

 

 

 
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6.2     Financial Statements, Reports, Certificates.

 

(a)     Deliver to Agent: (i) as soon as available, but no later than forty-five
(45) days after the last day of each month, a company prepared consolidated
balance sheet, income statement and cash flow statement covering Borrower’s
consolidated operations for such month certified by a Responsible Officer and in
a form reasonably acceptable to Agent; (ii) as soon as available, but no later
than one hundred fifty (150) days after the last day of Borrower’s fiscal year,
audited consolidated financial statements prepared under GAAP, consistently
applied, together with an unqualified opinion on the financial statements from
an independent certified public accounting firm acceptable to Agent in its
reasonable discretion; (iii) as soon as available after approval thereof by
Borrower’s Board of Directors, but no later than ninety (90) days after the last
day of Borrower’s fiscal year, Borrower’s financial projections for the current
fiscal year as approved by Borrower’s Board of Directors, which shall reflect
financial projections on no less than a quarterly basis; (iv) other than with
respect to reports made available in accordance with clause (v), below, within
five (5) days of delivery, copies of all statements, reports and notices made
available to all of Borrower’s security holders or to Subordinated Lender
pursuant to the requirements of the Subordinated Debt Documents or otherwise in
such Person’s capacity as Subordinated Lender; (v) so long as Borrower is
subject to the reporting requirements under the Securities Exchange Act of 1934,
as amended, within five (5) days of filing, all reports on Form 10-K, 10-Q and
8-K filed with the Securities and Exchange Commission or a link thereto on
Borrower’s or another website on the Internet; (vi) a prompt report of any legal
actions pending or threatened against Borrower or any of its Subsidiaries that
could be reasonably expected to result in damages or costs to Borrower or any of
its Subsidiaries of [*]2Dollars ($[*]) or more or could result in a Material
Adverse Change; (vii) budgets, sales projections, operating plans and other
financial information reasonably requested by Agent; and (viii) as soon as
available, but no later than thirty (30) days after the last day of each month,
copies of the month-end account statements for each Collateral Account
maintained by Borrower and each Subsidiary, which statements may be provided to
Agent and each Lender by Borrower or directly from the applicable
institution(s).

 

(b)     Within forty-five (45) days after the last day of each month, deliver to
Agent with the monthly financial statements described above, a duly completed
Compliance Certificate signed by a Responsible Officer.

 

(c)     Keep proper books of record and account in accordance with GAAP in which
full, true and correct entries shall be made of all dealings and transactions in
relation to its business and activities. Borrower shall allow, at the sole cost
of Borrower, Agent and Lenders to visit and inspect (such visit or inspection to
be during normal business hours so long as no Default or Event of Default
exists) any of its properties, to examine and make abstracts or copies from any
of Borrower’s books and records, to conduct a collateral audit and analysis of
its operations and the Collateral to verify the amount and age of the Accounts,
the identity and credit of the respective Account Debtors, to review the billing
practices of Borrower and to discuss its respective affairs, finances and
accounts with their respective officers, employees and independent public
accountants as often as may reasonably be desired. Notwithstanding the
foregoing, such audits shall be conducted at Borrower’s expense no more often
than once every twelve (12) months unless a Default or Event of Default has
occurred and is continuing.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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Within thirty (30) days of (i) acquiring and/or obtaining any new Subject
Intellectual Property, or (ii) enters into or becomes bound by any additional
license agreement (other than products that are commercially available to the
public), or upon any material change in Borrower’s existing Subject Intellectual
Property, deliver to Agent an updated Schedule 5.2(d) reflecting same. Borrower
shall use its commercially reasonable efforts to obtain the consent of, or
waiver by, any person whose consent or waiver is necessary for (x) all licenses
or agreements to be deemed “Collateral” and for Agent to have a security
interest in it that might otherwise be restricted or prohibited by Law or by the
terms of any such license or agreement, whether now existing or entered into in
the future, and (y) Agent to have the ability in the event of a liquidation of
any Collateral to dispose of such Collateral in accordance with Agent’s rights
and remedies under this Agreement and the other Loan Documents.

 

(d)     If, after the Second Restatement Date, Borrower determines to
manufacture, sell or market any new Sale Compound, Borrower shall give prior
written notice to Agent of such determination (which shall include a brief
description of such Sale Compound, plus a list of all Required Permits relating
to such new Sale Compound (and a copy of such Required Permits if requested by
Agent), along with a copy of an updated Schedule 5.11; provided, however, that
if Borrower shall at any time obtain any new or additional Required Permits from
the FDA, DEA, or parallel state or local authorities, or foreign counterparts of
the FDA, DEA, or parallel state or local authorities, with respect to any
Product which has previously been disclosed to Agent, Borrower shall promptly
give written notice to Agent of such new or additional Required Permits (along
with a copy thereof if requested by Agent).

 

6.3     Inventory; Returns. Keep all Sale Inventory in good and marketable
condition, free from material defects and keep all Development Inventory
manufactured for use in and/or used in clinical trials synthesized in accordance
with current “Good Manufacturing Practices’ and suitable for use in humans.
Returns and allowances between Borrower and its Account Debtors shall follow
such customary practices as may be established by Borrower and consistent with
industry practice if it engages in the sale of Sale Inventory. Borrower must
promptly notify Agent of all returns, recoveries, disputes and claims with
respect to Sale Inventory that involve more than [*]3Dollars ($[*]).

 

6.4     Taxes; Pensions. Timely file and require each of its Subsidiaries to
timely file, all required tax returns and reports and timely pay, and require
each of its Subsidiaries to timely file, all foreign, federal, state, and local
taxes, assessments, deposits and contributions owed by Borrower and each of its
Subsidiaries, except for deferred payment of any taxes contested pursuant to the
terms of Section 5.8 hereof, and shall deliver to Agent, on demand, appropriate
certificates attesting to such payments, and pay all amounts necessary to fund
all present pension, profit sharing and deferred compensation plans in
accordance with their terms.

 

6.5     Insurance. Keep its business and the Collateral insured for risks and in
amounts standard for companies in Borrower’s industry and location and as Agent
may reasonably request. Insurance policies shall be in a form, with companies,
and in amounts that are reasonably satisfactory to Agent. All property policies
shall have a lender’s loss payable endorsement showing Agent as lender loss
payee and waive subrogation against Agent, and all liability policies shall
show, or have endorsements showing, Agent, as an additional insured. All
policies (or the loss payable and additional insured endorsements) shall provide
that the insurer shall endeavor to give Agent at least thirty (30) days’ notice
before canceling, amending, or declining to renew its policy. At Agent’s
request, Borrower shall deliver certified copies of policies and evidence of all
premium payments. Proceeds payable under any policy shall, at Agent’s option, be
payable to Agent on behalf of the Lenders on account of the Obligations. If
Borrower fails to obtain insurance as required under this Section 6.5 or to pay
any amount or furnish any required proof of payment to third persons and Agent,
Agent may make all or part of such payment or obtain such insurance policies
required in this Section 6.5, and take any action under the policies Agent deems
prudent.

 

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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6.6     Operating Accounts.

 

(a)     Except for those Collateral Accounts listed on Schedule 5.2(a), maintain
all of its, and all of its Subsidiaries’, operating and other Deposit Accounts,
Securities Accounts, Investment Accounts and Commodity Accounts with Silicon
Valley Bank or its affiliates, as applicable, which operating and other Deposit
Accounts, Securities Accounts, Investment Accounts and Commodity Accounts with
Silicon Valley Bank or its affiliates shall contain no less than fifty percent
(50%) of Borrower’s total cash and Cash Equivalents.

 

(b)     Provide Agent five (5) days prior written notice before establishing any
Collateral Account at or with any bank or financial institution. In addition,
for each Collateral Account that Borrower at any time maintains, Borrower shall
cause the applicable bank or financial institution at or with which any
Collateral Account is maintained to execute and deliver a Control Agreement or
other appropriate instrument with respect to such Collateral Account to perfect
Agent’s Lien in such Collateral Account in accordance with the terms hereunder,
which Control Agreement may not be terminated without prior written consent of
Agent. The provisions of the previous sentence shall not apply to deposit
accounts exclusively used for payroll, payroll taxes and other employee wage and
benefit payments to or for the benefit of Borrower’s employees and identified to
Agent by Borrower as such.

 

6.7     Protection of Intellectual Property Rights. Borrower shall own, or be
licensed to use or otherwise have the right to use, all Material Intellectual
Property. All Subject Intellectual Property of Borrower is and shall be
protected and/or duly and properly registered, filed or issued in the
appropriate office and jurisdictions for such registrations, filings or
issuances, all in a manner consistent with industry standards for similar
businesses except where the failure to do so would not reasonably be expected to
result in a Material Adverse Change. Borrower shall not become a party to, nor
become bound by, any material license or similar agreement with respect to which
Borrower is the licensee thereunder that prohibits or otherwise restricts
Borrower from granting a security interest in Borrower’s rights under such
license agreement. Borrower shall at all times conduct its business without
knowingly committing infringement of any Intellectual Property rights of others.
Borrower shall, to the extent it determines, in the exercise of its reasonable
business judgment, that it is prudent to do the following: (a) protect, defend
and maintain the validity and enforceability of its Intellectual Property; (b)
promptly advise Agent in writing of material infringements of its Intellectual
Property; and (c) not allow any Material Intellectual Property to be abandoned,
forfeited or dedicated to the public without Agent’s prior written consent. If
Borrower (i) obtains any patent, registered trademark or servicemark, registered
copyright, registered mask work, or any pending application for any of the
foregoing, whether as owner, licensee or otherwise, or (ii) applies for any
patent or the registration of any trademark or servicemark, then Borrower shall
concurrently provide written notice thereof to Agent in accordance with Section
6.2(d) and concurrently with such notice, shall provide to Agent copies of all
applications that it filed for patents or for the registration of trademarks,
servicemarks, copyrights or mask works.

 

 

 
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6.8     Litigation Cooperation. From the date hereof and continuing through the
termination of this Agreement, make available to Agent, without expense to
Agent, Borrower and its officers, employees and agents and Borrower’s Books, to
the extent that Agent may deem them reasonably necessary to prosecute or defend
any third-party suit or proceeding instituted by or against Agent with respect
to any Collateral or relating to Borrower.

 

6.9     Notices of Litigation and Default. Borrower will give prompt written
notice to Agent of any litigation or governmental proceedings pending or
threatened (in writing) against Borrower which would reasonably be expected to
result in a Material Adverse Change. Without limiting or contradicting any other
more specific provision of this Agreement, promptly (and in any event within
three (3) Business Days) upon Borrower becoming aware of the existence of any
Event of Default or event which, with the giving of notice or passage of time,
or both, would constitute an Event of Default, Borrower shall give written
notice to Agent of such occurrence, which such notice shall include a reasonably
detailed description of such Event of Default or event which, with the giving of
notice or passage of time, or both, would constitute an Event of Default.

 

6.10     Creation/Acquisition of Subsidiaries.  Borrower shall not create or,
unless expressly permitted pursuant to this Agreement, acquire any Subsidiary,
except that, subject to Borrower’s compliance with the terms of this Section
6.10, Borrower may create new Domestic Subsidiaries. In the event that Borrower
or any direct or indirect Subsidiary of Borrower creates or acquires any
Subsidiary (and at all times subject to the Borrower being expressly permitted
to do so pursuant to this Agreement), Borrower and such Subsidiary shall
promptly (and in any event within five (5) Business Days of such creation or
acquisition) notify Agent of the creation or acquisition of such new Subsidiary
and take all such action as may be reasonably required by Agent to cause each
such Domestic Subsidiary to become a co-Borrower hereunder or to guarantee the
Obligations of Borrower under the Loan Documents and, in each case, grant a
continuing pledge and security interest in and to the assets of such Subsidiary
(substantially as described on Exhibit A hereto); and Borrower shall grant and
pledge to Agent, for the ratable benefit of the Lenders, a perfected security
interest in the stock, units or other evidence of ownership of each Subsidiary
(the foregoing collectively, the “Joinder Requirements”); provided, that
Borrower shall not be permitted to make any Investment in such Subsidiary until
such time as Borrower has satisfied the Joinder Requirements. Notwithstanding
the foregoing, Agent and Lenders agree that consent to Borrower forming a
Foreign Subsidiary shall not be unreasonably withheld, but shall in any event be
subject to satisfaction of all Joinder Requirements and other requirements that
Agent reasonably deems necessary and desirable in connection therewith.

 

6.11     Reserved.

 

6.12     Nesina License Agreement and Royalties. Without limiting the
restrictions set forth in Section 7.11, Borrower shall at all times maintain the
right to receive all royalty and milestone payments under and pursuant to the
Nesina License Agreement as in effect on the Second Restatement Date without
giving effect to any future amendments, restatements, supplements or other
modifications thereto.

 

 

 
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6.13     Further Assurances.

 

(a)     Execute any further instruments and take further action as Agent
reasonably requests to perfect or continue Agent’s Lien in the Collateral or to
effect the purposes of this Agreement.

 

(b)     Deliver to Agent, within five (5) days after the same are sent or
received, copies of all material correspondence, reports, documents and other
filings with any Governmental Authority that could reasonably be expected to
have a material adverse effect on any of the Governmental Approvals material to
Borrower’s business or otherwise result in a Material Adverse Change.

 

6.14     Post-Closing Obligations. Borrowers shall complete each of the post
closing obligations and/or deliver to Agent each of the documents, instruments,
agreements and information listed on Schedule 6.14 attached hereto, on or before
the date set forth for each such item thereon, each of which shall be completed
or provided in form and substance satisfactory to Agent and Lenders.

 

7.     NEGATIVE COVENANTS

 

No Borrower nor any Loan Party shall, nor shall Borrower or any Loan Party
permit any of its Subsidiaries to do, any of the following without the prior
written consent of Agent and Required Lenders:

 

7.1     Dispositions. Convey, sell, abandon, lease, license, transfer, assign,
grant a security in or otherwise dispose of (collectively, “Transfer”), or
permit any of its Subsidiaries to Transfer, all or any part of its business or
property, except for (a) the sale, lease or disposition of Inventory in the
Ordinary Course of Business; (b) the sale, lease or disposition of worn-out or
obsolete Equipment; (c) the payment of cash or Cash Equivalents in the Ordinary
Course of Business solely for the payment of costs and expenses associated with
operation of Borrower’s business, including without limitation expenditures
relating to (i) Borrower’s Phase I, Phase II and Phase III development
activities and (ii) the acquisition (including in-licensing) of additional
compounds so long as immediately after any such acquisition Borrower [*] based
on the financial projections delivered to Agent; (d) transfers of Intellectual
Property pursuant to outbound license agreements with third parties in the
Ordinary Course of Business so long as (i) Borrower receives not less than
$[*]4of net cash payments from each such license agreement that grants rights
with respect to the US market or globally which such amounts have been
fully-earned and are non-refundable at the time such license agreement is
consummated and (ii) at all times Borrower shall have rights necessary to
receive future milestone and royalty payments for at least two of Borrower’s
existing Products (“Permitted IP Dispositions”); (e) in connection with
Permitted Liens; or (f) the abandonment of Intellectual Property that does not
constitute Material Intellectual Property. Without limiting the foregoing,
Borrower agrees that it shall not grant a security interest or otherwise
encumber any of its Intellectual Property without Agent’s and Required Lenders’
prior written consent.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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7.2     Changes in Business, Management, Ownership or Business Locations.
(a) Other than the manufacture, marketing and sale of Sale Inventory, engage in
any business other than the businesses currently engaged in by Borrower or such
Subsidiary, as applicable, or reasonably related thereto; (b) liquidate or
dissolve; (c) (i) (A) have a change in any Responsible Officer position that
does not result in a qualified replacement or (B) the failure to fill a vacancy
with respect to any Responsible Officer position with a suitable qualified
replacement within ninety (90) days following such vacancy, or (ii) enter into
any transaction or series of related transactions which would constitute or
cause a Change in Control unless the documentation for such transaction
requires, as a condition precedent to such transaction, the consent of Agent and
Lenders or the payment in full of the Obligations; or (d) add any new offices or
business locations, including warehouses, where such new offices or business
locations contain more than [*]5Dollars ($[*]) in Borrower’s assets or property
or any of Borrowers’ Books or enter into any new leases with respect to existing
offices or business locations with respect to which an Access Agreement has
previously been executed in favor of Agent or is otherwise required with respect
to such location unless, prior to the addition of such new office, business
location or warehouse or execution of such new lease, Borrower obtains an Access
Agreement executed by the owner of such premises and Borrower in favor of Agent;
(e) change its jurisdiction of organization; (f) other than the creation or
acquisition of Subsidiaries in accordance with and subject to the conditions set
forth in Section 6.10 of this Agreement, change its organizational structure or
type; (g) change its legal name; or (h) change any organizational number (if
any) assigned by its jurisdiction of organization.

 

7.3     Mergers or Acquisitions. Merge or consolidate with any other Person, or
acquire all or substantially all of the capital stock or property of another
Person; provided, however, that a Subsidiary of Borrower may merge or
consolidate into another Subsidiary that is a Loan Party or into Borrower, so
long as (a) Borrower has provided Agent with prior written notice of such
transaction, (b) Borrower or such Loan Party shall be the surviving legal
entity, (c) Borrower’s or such Loan Party’s tangible net worth is not thereby
reduced, and (d) no Event of Default is occurring prior thereto or arises as a
result therefrom.

 

7.4     Indebtedness. Create, incur, assume, or be liable for any Indebtedness
other than Permitted Indebtedness.

 

7.5     Encumbrance. (a) Create, incur, allow, or suffer any Lien on any of its
property, or assign or convey any right to receive income, including the sale of
any Accounts, except for Permitted Liens, (b) permit any Collateral to fail to
be subject to the first priority security interest granted herein, or (c) enter
into any agreement, document, instrument or other arrangement (except with or in
favor of Agent) with any Person which directly or indirectly prohibits or has
the effect of prohibiting Borrower or any Subsidiary from collaterally
assigning, mortgaging, pledging, granting a security interest in or Lien upon
any of Borrower’s or any Subsidiary’s property (including, without limitation,
Intellectual Property), all of the foregoing except as is otherwise permitted in
Section 7.1 hereof and the definition of “Permitted Liens” herein.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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7.6     Maintenance of Collateral Accounts. Maintain any Collateral Account,
except pursuant to the terms of Section 6.6 hereof.

 

7.7     Distributions; Investments. (a) Pay any dividends (other than dividends
payable solely in common stock) or make any distribution or payment with respect
to or redeem, retire, purchase or repurchase any capital stock (other than
repurchases pursuant to the terms of employee stock purchase plans, employee
restricted stock agreements or similar plans), or (b) directly or indirectly
make any Investment (including, without limitation, any additional Investment in
any Subsidiary) other than Permitted Investments.

 

7.8     Transactions with Affiliates. Directly or indirectly enter into or
permit to exist any material transaction with any Affiliate of any Loan Party,
except for transactions that are in the Ordinary Course of Business, upon fair
and reasonable terms that are no less favorable to Borrower or such Loan Party
than would be obtained in an arm’s length transaction with a non-affiliated
Person.

 

7.9     Subordinated Debt. (a) Make or permit any payment on the Subordinated
Debt, except as permitted under the terms of the Subordination Agreement or (b)
amend any provision in any Subordinated Debt Document, other than as expressly
permitted pursuant to the terms of the Subordination Agreement.

 

7.10     Compliance. Become an “investment company” or a company controlled by
an “investment company”, under the Investment Company Act of 1940, as amended or
undertake as one of its important activities extending credit to purchase or
carry margin stock (as defined in Regulation U of the Board of Governors of the
Federal Reserve System), or use the proceeds of any Credit Extension for that
purpose; fail to meet the minimum funding requirements of ERISA, permit a
Reportable Event or Prohibited Transaction, as defined in ERISA, to occur; fail
to comply with the Federal Fair Labor Standards Act or violate any other Law or
regulation, if the violation could reasonably be expected to result in a
Material Adverse Change; withdraw or permit any Subsidiary to withdraw from
participation in, permit partial or complete termination of, or permit the
occurrence of any other event with respect to, any present pension, profit
sharing and deferred compensation plan which could reasonably be expected to
result in any liability of Borrower, including any liability to the Pension
Benefit Guaranty Corporation or its successors or any other governmental agency.

 

7.11     Amendments to Organization Documents and Material Agreements. Amend,
modify or waive any provision (or enter into any new agreement that has the same
practical effect) of (a) any Nesina Transaction Document or (b) any of its
organizational documents (other than a change in registered agents), in each
case under clause (a) or (b), without the prior written consent of Agent,
except, in the case of either clause (a) or (b), for such amendments,
modifications or waivers that are not adverse to Borrower or to the Agent or any
Lender. Borrower shall provide to Agent copies of all such amendments, waivers
and modifications.

 

 
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7.12     Compliance with Anti-Terrorism Laws. Directly or indirectly, knowingly
enter into any documents, instruments, agreements or contracts with any Person
listed on the OFAC Lists. Borrower shall immediately notify Agent if Borrower
has knowledge that Borrower or any Subsidiary or Affiliate is listed on the OFAC
Lists or (a) is convicted on, (b) pleads nolo contendere to, (c) is indicted on,
or (d) is arraigned and held over on charges involving money laundering or
predicate crimes to money laundering. Borrower will not, nor will Borrower
permit any Subsidiary or Affiliate to, directly or indirectly, (i) conduct any
business or engage in any transaction or dealing with any Blocked Person,
including, without limitation, the making or receiving of any contribution of
funds, goods or services to or for the benefit of any Blocked Person, (ii) deal
in, or otherwise engage in any transaction relating to, any property or
interests in property blocked pursuant to Executive Order No. 13224, any similar
executive order or other Anti-Terrorism Law, or (iii) engage in or conspire to
engage in any transaction that evades or avoids, or has the purpose of evading
or avoiding, or attempts to violate, any of the prohibitions set forth in
Executive Order No. 13224 or other Anti-Terrorism Law. Agent hereby notifies
Borrower that pursuant to the requirements of Anti-Terrorism Laws, and Agent’s
policies and practices, Agent is required to obtain, verify and record certain
information and documentation that identifies Borrower and its principals, which
information includes the name and address of Borrower and its principals and
such other information that will allow Agent to identify such party in
accordance with Anti-Terrorism Laws.

 

8.     EVENTS OF DEFAULT

 

Any one of the following shall constitute an event of default (an “Event of
Default”) under this Agreement:

 

8.1     Payment Default. Borrower fails to (a) make any payment of principal or
interest on any Credit Extension on its due date, or (b) pay any other
Obligations within three (3) Business Days after such Obligations are due and
payable (which three (3) Business Day grace period shall not apply to payments
due on the Maturity Date or the date of acceleration pursuant to Section 9.1 (a)
hereof). During the cure period, the failure to cure the payment default is not
an Event of Default (but no Credit Extension will be made during the cure
period);

 

8.2     Covenant Default.

 

(a)     Borrower fails or neglects to perform any obligation in Sections 6.1(c),
6.2, 6.4, 6.5, 6.6, 6.7, 6.10, 6.12, 6.13 or 6.14 or violates any covenant in
Section 7; or

 

(b)     Borrower or any of its Subsidiaries fails or neglects to perform, keep,
or observe any other term, provision, condition, covenant or agreement contained
in this Agreement or any Loan Documents, and as to any default (other than those
specified in this Section 8) under such other term, provision, condition,
covenant or agreement that can be cured, has failed to cure the default within
twenty (20) days after the occurrence thereof; provided, however, that if the
default cannot by its nature be cured within the twenty (20) day period or
cannot after diligent attempts by Borrower be cured within such twenty (20) day
period, and such default is likely to be cured within a reasonable time, then
Borrower shall have an additional period (which shall not in any case exceed
thirty (30) days) to attempt to cure such default, and within such reasonable
time period the failure to cure the default shall not be deemed an Event of
Default (but no Credit Extensions shall be made during such cure period). Grace
periods provided under this Section shall not apply, among other things, to any
covenant set forth in subsection (a) above;

 

 

 
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8.3     Material Adverse Change. A Material Adverse Change occurs;

 

8.4     Attachment; Levy; Restraint on Business.

 

(a)     (i) The service of process seeking to attach, by trustee or similar
process, any funds of Borrower or of any entity under control of Borrower
(including a Subsidiary) on deposit with the Lenders or any Lender Affiliate, or
(ii) a notice of lien, levy, or assessment is filed against any of Borrower’s
assets by any government agency, and the same under subclauses (i) and (ii)
hereof are not, within ten (10) days after the occurrence thereof, discharged or
stayed (whether through the posting of a bond or otherwise); provided, however,
no Credit Extensions shall be made during any ten (10) day cure period; and

 

(b)     (i) any material portion of Borrower’s assets is attached, seized,
levied on, or comes into possession of a trustee or receiver, or (ii) any court
order enjoins, restrains, or prevents Borrower from conducting any material
portion of its business;

 

8.5     Insolvency. (a) Borrower is unable to pay its debts (including trade
debts) as they become due or otherwise becomes insolvent; (b) Borrower begins an
Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower
and not dismissed or stayed within thirty (30) days (but no Credit Extensions
shall be made while any of the conditions described in clause (a) exist and/or
until any Insolvency Proceeding is dismissed);

 

8.6     Other Agreements. There is a default in any agreement to which Borrower
is a party with a third party or parties resulting in a right by such third
party or parties, whether or not exercised, to accelerate the maturity of any
Indebtedness in an amount in excess of Two Hundred Fifty Thousand Dollars
($250,000) or that could reasonably be expected to result in a Material Adverse
Change and such default has not been waived in writing by such third party or
parties;

 

8.7     Judgments. One or more judgments, orders, or decrees for the payment of
money in an amount, individually or in the aggregate, of at least [*]6Dollars
($[*]) (not covered by independent third-party insurance as to which liability
has been accepted by such insurance carrier) shall be rendered against Borrower
and shall remain unsatisfied, unvacated, or unstayed for a period of fifteen
(15) days after the entry thereof, provided, however, that no Credit Extensions
will be made prior to the satisfaction, vacation, or stay of such judgment,
order or decree;

 

8.8     Misrepresentations. Borrower or any Person acting for Borrower makes any
representation, warranty, or other statement now or later in this Agreement, any
Loan Document or in any writing delivered to Agent and/or the Lenders or to
induce Agent and/or the Lenders to enter this Agreement or any Loan Document,
and such representation, warranty, or other statement is incorrect in any
material respect when made;

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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8.9     Subordinated Debt. Any breach or default occurs under any terms or
provisions of any Subordinated Debt Document or under any agreement
subordinating the Subordinated Debt to all or any portion of the Obligations or
the occurrence of any event requiring the prepayment of any Subordinated Debt;

 

8.10     Governmental Approvals. Any Governmental Approval shall have been
(a) revoked, rescinded, suspended, modified in an adverse manner or not renewed
in the Ordinary Course of Business for a full term, or (b) subject to any
decision by a Governmental Authority that designates a hearing with respect to
any applications for renewal of any of such Governmental Approval or that could
result in the Governmental Authority taking any of the actions described in
clause (a) above, and such decision or such revocation, rescission, suspension,
modification or non-renewal (i) has resulted in, or could reasonably be expected
to result in, a Material Adverse Change, or (ii) adversely affects the legal
qualifications of Borrower or any of its Subsidiaries to hold such Governmental
Approval in any applicable jurisdiction and such revocation, rescission,
suspension, modification or non-renewal could reasonably be expected to affect
the status of or legal qualifications of Borrower or any of its Subsidiaries to
hold any Governmental Approval in any other jurisdiction;

 

8.11     Criminal Proceeding. The institution by any Governmental Authority of
criminal proceedings against Borrower either (a) involving fraud, moral
turpitude, or a felony, or (b) that could reasonably be expected to result in a
Material Adverse Change;

 

8.12     Lien Priority. Except as permitted by Agent and the Required Lenders,
any Lien created hereunder or by any other Loan Document shall at any time fail
to constitute a valid and perfected Lien on all of the Collateral purported to
be secured thereby, subject to no prior or equal Lien;

 

8.13     Change in Control. A Change in Control shall have occurred;

 

8.14     Withdrawals, Recalls, Adverse Test Results and Other Matters not
Involving Nesina. The institution of any proceeding by FDA or similar
Governmental Authority to order the withdrawal of any Sale Compound from the
market or to enjoin Borrower or any representative of Borrower from
manufacturing, marketing, selling or distributing any Sale Compound, which, in
each case, could reasonably be expected to result in a Material Adverse Change,
(b) the institution of any action or proceeding by any DEA, FDA, or any other
Governmental Authority to revoke, suspend, reject, withdraw, limit, or restrict
any Required Permit held by Borrower or any representative of Borrower, which,
in each case, could reasonably be expected to result in a Material Adverse
Change, (c) the commencement of any enforcement action against Borrower by DEA,
FDA, or any other Governmental Authority; (d) the recall of any Sale Compound
from the market, the voluntary withdrawal of any Sale Compound from the market,
or actions to discontinue the sale of any Sale Compound, which in each case
could reasonably be expected to result in a Material Adverse Change, or (e) the
occurrence of serious adverse test results related to the safety or efficacy of
a Development Compound resulting in the termination of all clinical studies for
such Development Compound which could reasonably be expected to result in a
Material Adverse Change; or

 

 

 
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8.15     Withdrawals and Other Matters Involving Nesina.  (a) The institution of
any proceeding by the FDA in the United States or similar Governmental Authority
in the European Union to order the withdrawal of any marketing authorization
granting the right to sell Nesina in the United States or the European Union or
to enjoin Borrower or Takeda (or any of its permitted assignees under the Nesina
License Agreement) from manufacturing, marketing, selling or distributing Nesina
in the United States or the European Union, which, in each case, could
reasonably be expected to result in a Material Adverse Change, (b) the
institution of any proceeding by the Japanese Ministry of Health, Labour and
Welfare or similar Governmental Authority to (i) order the withdrawal of the
marketing authorization granting the right to sell Nesina in Japan or (ii)
indefinitely enjoin Borrower or Takeda (or any of its permitted assignees under
the Nesina License Agreement) from, marketing or selling Nesina in Japan, (c)
the indefinite voluntary withdrawal of Nesina from the market in (i) the United
States or European Union, in each case where such voluntary withdrawal could
reasonably be expected to result in a Material Adverse Change, or (ii) Japan,
(d)  Nesina, for any reason, indefinitely ceases to be sold or marketed in Japan
or Borrower is no longer contractually entitled to royalty payments with respect
to Nesina in Japan.

 

9.     RIGHTS AND REMEDIES

 

9.1     Rights and Remedies.

 

(a)      Upon the occurrence and during the continuance of an Event of Default,
Agent may, and at the written direction of the Required Lenders shall, without
notice or demand, do any or all of the following: (i) deliver notice of the
Event of Default to Borrower, (ii) by notice to Borrower declare all Obligations
immediately due and payable (but if an Event of Default described in Section 8.5
occurs all Obligations shall be immediately due and payable without any action
by Agent or the Lenders), or (iii) by notice to Borrower suspend or terminate
the obligations, if any, of the Lenders to advance money or extend credit for
Borrower’s benefit under this Agreement or under any other agreement between
Borrower and Agent and/or the Lenders (but if an Event of Default described in
Section 8.5 occurs all obligations, if any, of the Lenders to advance money or
extend credit for Borrower’s benefit under this Agreement or under any other
agreement between Borrower and Agent and/or the Lenders shall be immediately
terminated without any action by Agent or the Lenders).

 

(b)     Without limiting the rights of Agent and Lenders set forth in Section
9.1(a) above, upon the occurrence and during the continuance of an Event of
Default Agent shall have the right, at the written direction of the Required
Lenders, without notice or demand, to do any or all of the following:

 

(i)      foreclose upon and/or sell or otherwise liquidate, the Collateral;

 

(ii)      apply to the Obligations any (a) balances and deposits of Borrower
that Agent or any Lender holds or controls, or (b) any amount held or controlled
by Agent or any Lender owing to or for the credit or the account of Borrower;
and/or

 

(iii)      commence and prosecute an Insolvency Proceeding or consent to
Borrower commencing any Insolvency Proceeding.

 

 

 
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(c)      Without limiting the rights of Agent and Lenders set forth in Sections
9.1(a) and (b) above, upon the occurrence and during the continuance of an Event
of Default Agent shall have the right, without notice or demand, to do any or
all of the following:

 

(i)      settle or adjust disputes and claims directly with Account Debtors for
amounts on terms and in any order that Agent considers advisable, notify any
Person owing Borrower money of Agent’s security interest in such funds, and
verify the amount of such Account;

 

(ii)      make any payments and do any acts it considers necessary or reasonable
to protect the Collateral and/or its security interest in the Collateral.
Borrower shall assemble the Collateral if Agent requests and make it available
as Agent designates. Agent may enter premises where the Collateral is located,
take and maintain possession of any part of the Collateral, and pay, purchase,
contest, or compromise any Lien which appears to be prior or superior to its
security interest and pay all expenses incurred. Borrower grants Agent a license
to enter and occupy any of its premises, without charge, to exercise any of
Agent’s rights or remedies;

 

(iii)      ship, reclaim, recover, store, finish, maintain, repair, prepare for
sale, and/or advertise for sale, the Collateral. Agent is hereby granted a
non-exclusive, royalty-free license or other right to use, without charge,
Borrower’s labels, patents, copyrights, mask works, rights of use of any name,
trade secrets, trade names, trademarks, service marks, and advertising matter,
or any similar property as it pertains to the Collateral, in completing
production of, advertising for sale, and selling any Collateral and, in
connection with Agent’s exercise of its rights under this Section 9.1,
Borrower’s rights under all licenses and all franchise agreements inure to Agent
for the benefit of the Lenders;

 

(iv)      place a “hold” on any account maintained with Agent or the Lenders
and/or deliver a notice of exclusive control, any entitlement order, or other
directions or instructions pursuant to any Control Agreement or similar
agreements providing control of any Collateral;

 

(v)      demand and receive possession of Borrower’s Books; and

 

(vi)      subject to clauses 9.1(a) and (b), exercise all rights and remedies
available to Agent under the Loan Documents or at law or equity, including all
remedies provided under the Code (including disposal of the Collateral pursuant
to the terms thereof).

 

Notwithstanding any provision of this Section 9.1 to the contrary, upon the
occurrence of any Event of Default, Agent shall have the right to exercise any
and all remedies referenced in this Section 9.1 without the written consent of
Required Lenders following the occurrence of an Exigent Circumstance. As used in
the immediately preceding sentence, “Exigent Circumstance” means any event or
circumstance that, in the reasonable judgment of Agent, imminently threatens the
ability of Agent to realize upon all or any material portion of the Collateral,
such as, without limitation, fraudulent removal, concealment, or abscondment
thereof, destruction or material waste thereof, or failure of Borrower after
reasonable demand to maintain or reinstate adequate casualty insurance coverage,
or which, in the judgment of Agent, could result in a material diminution in
value of the Collateral.

 

 

 
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9.2     Power of Attorney. Borrower hereby irrevocably appoints Agent as its
lawful attorney-in-fact, exercisable upon the occurrence and during the
continuance of an Event of Default, to: (a) endorse Borrower’s name on any
checks or other forms of payment or security; (b) sign Borrower’s name on any
invoice or bill of lading for any Account or drafts against Account Debtors; (c)
settle and adjust disputes and claims about the Accounts directly with Account
Debtors, for amounts and on terms Agent determines reasonable; (d) make, settle,
and adjust all claims under Borrower’s insurance policies; (e) pay, contest or
settle any Lien, charge, encumbrance, security interest, and adverse claim in or
to the Collateral, or any judgment based thereon, or otherwise take any action
to terminate or discharge the same; and (f) transfer the Collateral into the
name of Agent or a third party as the Code permits. Borrower hereby appoints
Agent as its lawful attorney-in-fact to sign Borrower’s name on any documents
necessary to perfect or continue the perfection of Agent’s security interest in
the Collateral regardless of whether an Event of Default has occurred until all
Obligations have been satisfied in full and Agent and the Lenders are under no
further obligation to make Credit Extensions hereunder. Agent’s foregoing
appointment as Borrower’s attorney in fact, and all of Agent’s rights and
powers, coupled with an interest, are irrevocable until all Obligations have
been fully repaid and performed and Agent’s and the Lenders’ obligation to
provide Credit Extensions terminates.

 

9.3     Protective Payments. If Borrower fails to obtain the insurance called
for by Section 6.5 or fails to pay any premium thereon or fails to pay any other
amount which Borrower is obligated to pay under this Agreement or any other Loan
Document, Agent may obtain such insurance or make such payment, and all amounts
so paid by Agent are Lenders’ Expenses and immediately due and payable, bearing
interest at the then highest applicable rate, and secured by the Collateral.
Agent will make reasonable efforts to provide Borrower with notice of Agent
obtaining such insurance at the time it is obtained or within a reasonable time
thereafter. No such payments by Agent are deemed an agreement to make similar
payments in the future or Agent’s waiver of any Event of Default.

 

9.4     Application of Payments and Proceeds. Notwithstanding anything to the
contrary contained in this Agreement, upon the occurrence and during the
continuance of an Event of Default, (a) Borrower irrevocably waives the right to
direct the application of any and all payments at any time or times thereafter
received by Agent from or on behalf of Borrower of all or any part of the
Obligations, and, as between Borrower on the one hand and Agent and Lenders on
the other, Agent shall have the continuing and exclusive right to apply and to
reapply any and all payments received against the Obligations in such manner as
Agent may deem advisable notwithstanding any previous application by Agent, and
(b) the proceeds of any sale of, or other realization upon all or any part of
the Collateral shall be applied: first, to the Lenders Expenses; second, to
accrued and unpaid interest on the Obligations (including any interest which,
but for the provisions of the United States Bankruptcy Code, would have accrued
on such amounts); third, to the principal amount of the Obligations outstanding;
and fourth, to any other indebtedness or obligations of Borrower owing to Agent
or any Lender under the Loan Documents. Any balance remaining shall be delivered
to Borrower or to whoever may be lawfully entitled to receive such balance or as
a court of competent jurisdiction may direct. In carrying out the foregoing, (x)
amounts received shall be applied in the numerical order provided until
exhausted prior to the application to the next succeeding category, and (y) each
of the Persons entitled to receive a payment in any particular category shall
receive an amount equal to its pro rata share of amounts available to be applied
pursuant thereto for such category. Any reference in this Agreement to an
allocation between or sharing by the Lenders of any right, interest or
obligation “ratably,” “proportionally” or in similar terms shall refer to Pro
Rata Share unless expressly provided otherwise. Agent, or if applicable, each
Lender, shall promptly remit to the other Lenders such sums as may be necessary
to ensure the ratable repayment of each Lender’s portion of any Term Loan and
the ratable distribution of interest, fees and reimbursements paid or made by
Borrower. Notwithstanding the foregoing, a Lender receiving a scheduled payment
shall not be responsible for determining whether the other Lenders also received
their scheduled payment on such date; provided, however, if it is later
determined that a Lender received more than its ratable share of scheduled
payments made on any date or dates, then such Lender shall remit to the Agent or
other Lenders such sums as may be necessary to ensure the ratable payment of
such scheduled payments, as instructed by Agent. Any payment or distribution of
any kind or character, whether in cash, properties or securities, shall be
received by a Lender in excess of its ratable share, then the portion of such
payment or distribution in excess of such Lender’s ratable share shall be
received by such Lender in trust for and shall be promptly paid over to the
other Lender for application to the payments of amounts due on the other
Lender’s claims. To the extent any payment for the account of Borrower is
required to be returned as a voidable transfer or otherwise, the Lenders shall
contribute to one another as is necessary to ensure that such return of payment
is on a pro rata basis. If any Lender shall obtain possession of any Collateral,
it shall hold such Collateral for itself and as agent and bailee for the Agent
and other Lenders for purposes of perfecting Agent’s security interest therein.
Notwithstanding anything to the contrary herein, any warrants issued to the
Lenders by Borrower, the stock issuable thereunder, any equity securities
purchased by Lenders, any amounts paid thereunder, any dividends, and any other
rights in connection therewith shall not be subject to the terms and conditions
of this Agreement. Nothing herein shall affect any Lender’s rights under any
such warrants, stock, or other equity securities to administer, manage,
transfer, assign, or exercise such warrants, stock, or other equity securities
for its own account.

 

 

 
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9.5     Liability for Collateral. So long as Agent and the Lenders comply with
reasonable banking practices regarding the safekeeping of the Collateral in the
possession or under the control of Agent and the Lenders, Agent and the Lenders
shall not be liable or responsible for: (a) the safekeeping of the Collateral;
(b) any loss or damage to the Collateral; (c) any diminution in the value of the
Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or
other Person. Borrower bears all risk of loss, damage or destruction of the
Collateral.

 

9.6     No Waiver; Remedies Cumulative. Agent’s failure, at any time or times,
to require strict performance by Borrower of any provision of this Agreement or
any other Loan Document shall not waive, affect, or diminish any right of Agent
thereafter to demand strict performance and compliance herewith or therewith. No
waiver hereunder shall be effective unless signed by Agent and/or Lenders, as
applicable in accordance with Section 12.12. Agent’s rights and remedies under
this Agreement and the other Loan Documents are cumulative. Agent has all rights
and remedies provided under the Code, by Law, or in equity. Agent’s exercise of
one right or remedy is not an election, and Agent’s waiver of any Event of
Default is not a continuing waiver. Agent’s delay in exercising any remedy is
not a waiver, election, or acquiescence.

 

9.7     Demand Waiver. Borrower waives demand, notice of default or dishonor,
notice of payment and nonpayment, notice of any default, nonpayment at maturity,
release, compromise, settlement, extension, or renewal of accounts, documents,
instruments, chattel paper, and guarantees held by Agent on which Borrower is
liable.

 

9.8     Borrower Liability. Each Borrower hereby appoints the others as agent
for the others for all purposes hereunder, including with respect to requesting
the Term Loan hereunder. Each Borrower hereunder shall be jointly and severally
obligated to repay the Term Loan made hereunder and all other Obligations,
regardless of which Borrower actually receives said Term Loan, as if each
Borrower hereunder directly received the Term Loan.  Each Borrower waives
(a) any suretyship defenses available to it under the Code or any other
applicable law, and (b) any right to require the Lenders or Agent to: (i)
proceed against any Borrower or any other person; (ii) proceed against or
exhaust any security; or (iii) pursue any other remedy.  The Lenders or Agent
may exercise or not exercise any right or remedy they have against any Borrower
or any security (including the right to foreclose by judicial or non-judicial
sale) without affecting any Borrower’s liability.  Notwithstanding any other
provision of this Agreement or other related document, each Borrower irrevocably
waives all rights that it may have at law or in equity (including, without
limitation, any law subrogating Borrower to the rights of the Lenders and Agent
under this Agreement) to seek contribution, indemnification or any other form of
reimbursement from any other Borrower, or any other Person now or hereafter
primarily or secondarily liable for any of the Obligations, for any payment made
by Borrower with respect to the Obligations in connection with this Agreement or
otherwise and all rights that it might have to benefit from, or to participate
in, any security for the Obligations as a result of any payment made by Borrower
with respect to the Obligations in connection with this Agreement or otherwise. 
Any agreement providing for indemnification, reimbursement or any other
arrangement prohibited under this Section shall be null and void.  If any
payment is made to a Borrower in contravention of this Section, such Borrower
shall hold such payment in trust for the Lenders and Agent and such payment
shall be promptly delivered to Agent for application to the Obligations, whether
matured or unmatured.

 

10.     NOTICES

 

All notices, consents, requests, approvals, demands, or other communication
(collectively, “Communication”) by any party to this Agreement or any other Loan
Document must be in writing and shall be deemed to have been validly served,
given, or delivered: (a) upon the earlier of actual receipt and three (3)
Business Days after deposit in the U.S. mail, first class, registered or
certified mail return receipt requested, with proper postage prepaid; (b) upon
transmission, when sent by electronic mail (if an email address is specified
herein) or facsimile transmission; (c) one (1) Business Day after deposit with a
reputable overnight courier with all charges prepaid; or (d) when delivered, if
hand-delivered by messenger, all of which shall be addressed to the party to be
notified and sent to the address, facsimile number, or email address indicated
below. Any of Agent, Lender or Borrower may change its mailing or electronic
mail address or facsimile number by giving the other party written notice
thereof in accordance with the terms of this Section 10.

 

 

 
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If to any Borrower:

 

Furiex Pharmaceuticals, Inc.

3900 Paramount Parkway, Suite 150

Morrisville, North Carolina 27560

Attention: President and Chief Financial Officer

Fax: (919) 456-7850

E-Mail: June.Almenoff@furiex.com

Marshall.Woodworth@furiex.com

 

If to Agent :

 

MidCap Funding III, LLC

7255 Woodmont Avenue, Suite 200

Bethesda, Maryland 20814

Attention: Portfolio Management- Life Sciences

Fax: (301) 941-1450

E-Mail: Lviera@midcapfinancial.com

 

with a copy to:

 

Midcap Financial, LLC 

7255 Woodmont Avenue, Suite 200

Bethesda, Maryland 20814

Attention: General Counsel

Fax: (301) 941-1450

E-Mail: Rgoodridge@midcapfinancial.com

 

If to Lenders: To the address specified on the signature page of such Lender
attached hereto or on any Assignment Agreement to which such Lender has become a
party to this Agreement in accordance with Section 12.1.

 

11.     CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER

 

THIS AGREEMENT, EACH SECURED PROMISSORY NOTE AND EACH OTHER LOAN DOCUMENT, AND
ALL MATTERS RELATING HERETO OR THERETO OR ARISING THEREFROM (WHETHER SOUNDING IN
CONTRACT LAW, TORT LAW OR OTHERWISE), SHALL BE GOVERNED BY, AND SHALL BE
CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF MARYLAND,
WITHOUT REGARD TO CONFLICTS OF LAWS PRINCIPLES. NOTWITHSTANDING THE FOREGOING,
AGENT AND LENDERS SHALL HAVE THE RIGHT TO BRING ANY ACTION OR PROCEEDING AGAINST
BORROWER OR ITS PROPERTY IN THE COURTS OF ANY OTHER JURISDICTION WHICH AGENT AND
LENDERS (IN ACCORDANCE WITH THE PROVISIONS OF SECTION 9.1) DEEM NECESSARY OR
APPROPRIATE TO REALIZE ON THE COLLATERAL OR TO OTHERWISE ENFORCE AGENT’S AND
LENDERS’ RIGHTS AGAINST BORROWER OR ITS PROPERTY. BORROWER EXPRESSLY SUBMITS AND
CONSENTS IN ADVANCE TO SUCH JURISDICTION IN ANY ACTION OR SUIT COMMENCED IN ANY
SUCH COURT, AND BORROWER HEREBY WAIVES ANY OBJECTION THAT IT MAY HAVE BASED UPON
LACK OF PERSONAL JURISDICTION, IMPROPER VENUE, OR FORUM NON CONVENIENS AND
HEREBY CONSENTS TO THE GRANTING OF SUCH LEGAL OR EQUITABLE RELIEF AS IS DEEMED
APPROPRIATE BY SUCH COURT. BORROWER HEREBY WAIVES PERSONAL SERVICE OF THE
SUMMONS, COMPLAINTS, AND OTHER PROCESS ISSUED IN SUCH ACTION OR SUIT AND AGREES
THAT SERVICE OF SUCH SUMMONS, COMPLAINTS, AND OTHER PROCESS MAY BE MADE BY
REGISTERED OR CERTIFIED MAIL ADDRESSED TO BORROWER AT THE ADDRESS SET FORTH IN
SECTION 10 OF THIS AGREEMENT AND THAT SERVICE SO MADE SHALL BE DEEMED COMPLETED
UPON THE EARLIER TO OCCUR OF BORROWER’S ACTUAL RECEIPT THEREOF OR THREE (3) DAYS
AFTER DEPOSIT IN THE U.S. MAILS, PROPER POSTAGE PREPAID.

 

 

 
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TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER, AGENT AND LENDERS
EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING
OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED
TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS
WAIVER IS A MATERIAL INDUCEMENT FOR BOTH PARTIES TO ENTER INTO THIS AGREEMENT.
EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.

 

Borrower, Agent and each Lender agree that the Term Loan (including those
portions of the Term Loan made on each of the 2011 Closing Date and the
Restatement Date), shall be deemed to be made in, and the transactions
contemplated hereunder and in any other Loan Document shall be deemed to have
been performed in, the State of Maryland.

 

12.     GENERAL PROVISIONS

 

12.1     Successors and Assigns. This Agreement binds and is for the benefit of
the successors and permitted assigns of each party. Borrower may not assign this
Agreement or any rights or obligations under it without Agent’s and each
Lender’s prior written consent (which may be granted or withheld in Agent’s
discretion). Any Lender may at any time assign to one or more Eligible Assignees
all or any portion of such Lender’s Loan, together with all related obligations
of such Lender hereunder. Borrower and Agent shall be entitled to continue to
deal solely and directly with such Lender in connection with the interests so
assigned until Agent shall have received and accepted an effective assignment
agreement in form and substance acceptable to Agent, executed, delivered and
fully completed by the applicable parties thereto (each, an “Assignment
Agreement”), and shall have received such other information regarding such
Eligible Assignee as Agent reasonably shall require. Notwithstanding anything
set forth in this Agreement to the contrary, any Lender may at any time pledge
or assign a security interest in all or any portion of its rights under this
Agreement to secure obligations of such Lender, including any pledge or
assignment to secure obligations to a Federal Reserve Bank; provided, however,
that no such pledge or assignment shall release such Lender from any of its
obligations hereunder or substitute any such pledgee or assignee for such Lender
as a party hereto.

 

 

 
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12.2     Indemnification.

 

(a)     Borrower agrees to indemnify, defend and hold Agent and the Lenders and
their respective directors, officers, employees, agents, attorneys, or any other
Person affiliated with or representing Agent or the Lenders (each, an
“Indemnified Person”) harmless against: (i) all obligations, demands, claims,
and liabilities (collectively, “Claims”) asserted by any other party in
connection with the transactions contemplated by the Loan Documents; and (ii)
all losses or Lenders’ Expenses incurred, or paid by Indemnified Person from,
following, or arising from transactions between Agent, and/or the Lenders and
Borrower (including reasonable attorneys’ fees and expenses) pursuant to or in
connection with the Loan Documents, except for Claims and/or losses directly
caused by such Indemnified Person’s gross negligence or willful misconduct
(collectively, the “Indemnified Liabilities”).

 

(b)     Borrower hereby further indemnifies, defends and holds each Indemnified
Person harmless from and against any and all liabilities, obligations, losses,
damages, penalties, actions, judgments, suits, claims, costs, expenses and
disbursements of any kind or nature whatsoever (including the fees and
disbursements of counsel for such Indemnitee) in connection with any
investigative, response, remedial, administrative or judicial matter or
proceeding, whether or not such Indemnified Person shall be designated a party
thereto and including any such proceeding initiated by or on behalf of Borrower,
and the reasonable expenses of investigation by engineers, environmental
consultants and similar technical personnel and any commission, fee or
compensation claimed by any broker (other than any broker retained by Agent or
Lenders) asserting any right to payment for the transactions contemplated hereby
which may be imposed on, incurred by or asserted against such Indemnified Person
as a result of or in connection with the transactions contemplated hereby and
the use or intended use of the proceeds of the loan proceeds.

 

(c)     To the extent that the undertaking set forth in this Section 12.2 may be
unenforceable, Borrower shall contribute the maximum portion which it is
permitted to pay and satisfy under applicable law to the payment and
satisfaction of all such indemnified liabilities incurred by the Indemnitees or
any of them.

 

12.3     Time of Essence. Time is of the essence for the performance of all
Obligations in this Agreement.

 

12.4     Severability of Provisions. Each provision of this Agreement is
severable from every other provision in determining the enforceability of any
provision.

 

12.5     Correction of Loan Documents. Agent and the Lenders may correct patent
errors and fill in any blanks in this Agreement and the other Loan Documents
consistent with the agreement of the parties.

 

12.6     Integration. This Agreement and the Loan Documents represent the entire
agreement about this subject matter and supersede prior negotiations or
agreements. All prior agreements, understandings, representations, warranties,
and negotiations between the parties about the subject matter of this Agreement
and the Loan Documents merge into this Agreement and the Loan Documents.

 

 

 
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12.7     Counterparts. This Agreement may be executed in any number of
counterparts and by different parties on separate counterparts, each of which,
when executed and delivered, is an original, and all taken together, constitute
one Agreement.

 

12.8     Survival. All covenants, representations and warranties made in this
Agreement continue in full force until this Agreement has terminated pursuant to
its terms and all Obligations (other than inchoate indemnity obligations and any
other obligations which, by their terms, are to survive the termination of this
Agreement) have been satisfied. The obligation of Borrower in Section 12.2 to
indemnify each Lender and Agent shall survive until the statute of limitations
with respect to such claim or cause of action shall have run.

 

12.9     Confidentiality. In handling any confidential information of Borrower,
the Lenders and Agent shall exercise the same degree of care that it exercises
for its own proprietary information, but disclosure of information may be made:
(a) to the Lenders’ and Agent’s Subsidiaries or Affiliates; (b) to prospective
transferees or purchasers of any interest in the Credit Extensions (provided,
however, the Lenders and Agent shall use commercially reasonable efforts to
obtain such prospective transferee’s or purchaser’s agreement to the terms of
this provision); (c) as required by Law, regulation, subpoena, or other order;
(d) to regulators or as otherwise required in connection with an examination or
audit; (e) as Agent considers appropriate in exercising remedies under the Loan
Documents; and (f) to third party service providers of the Lenders and/or Agent
so long as such service providers have executed a confidentiality agreement with
the Lenders and Agent with terms no less restrictive than those contained
herein. Confidential information does not include information that either: (i)
is in the public domain or in the Lenders’ and/or Agent’s possession when
disclosed to the Lenders and/or Agent, or becomes part of the public domain
after disclosure to the Lenders and/or Agent; or (ii) is disclosed to the
Lenders and/or Agent by a third party, if the Lenders and/or Agent does not know
that the third party is prohibited from disclosing the information. Agent and/or
Lenders may use confidential information for any purpose, including, without
limitation, for the development of client databases, reporting purposes, and
market analysis, so long as Agent and/or Lenders, as applicable, do not disclose
Borrower’s identity or the identity of any Person associated with Borrower
unless otherwise expressly permitted by this Agreement. The provisions of the
immediately preceding sentence shall survive the termination of this Agreement.
The agreements provided under this Section 12.9 supersede all prior agreements,
understanding, representations, warranties, and negotiations between the parties
about the subject matter of this Section 12.9.

 

12.10     Right of Set Off. Borrower hereby grants to Agent and to each Lender,
a lien, security interest and right of set off as security for all Obligations
to Agent and each Lender hereunder, whether now existing or hereafter arising
upon and against all deposits, credits, collateral and property, now or
hereafter in the possession, custody, safekeeping or control of Agent or the
Lenders or any entity under the control of Agent or the Lenders (including an
Agent affiliate) or in transit to any of them. At any time after the occurrence
and during the continuance of an Event of Default, without demand or notice,
Agent or the Lenders may set off the same or any part thereof and apply the same
to any liability or obligation of Borrower even though unmatured and regardless
of the adequacy of any other collateral securing the Obligations. ANY AND ALL
RIGHTS TO REQUIRE AGENT TO EXERCISE ITS RIGHTS OR REMEDIES WITH RESPECT TO ANY
OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF
SETOFF WITH RESPECT TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER ARE
HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY WAIVED.

 

 

 
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12.11     [Reserved.]

 

12.12     Amendments.

 

(a)      No amendment, modification, termination or waiver of any provision of
this Agreement or any other Loan Document, nor approval or consent thereunder,
or any consent to any departure by Borrower therefrom (in each case, other than
amendments, waivers, approvals or consents deemed ministerial by Agent), shall
in any event be effective unless the same shall be in writing and signed by
Borrower, Agent and the Required Lenders, provided, however, that

 

(i)     no such amendment, waiver or other modification that would have the
effect of increasing or reducing a Lender’s Term Loan Commitment or Commitment
Percentage shall be effective as to such Lender without such Lender’s written
consent;

 

(ii)     no such amendment, waiver or modification that would affect the rights
and duties of Agent shall be effective without Agent’s written consent or
signature;

 

(iii)     no such amendment, waiver or other modification shall, unless signed
by all the Lenders directly affected thereby, (A) reduce the principal of, rate
of interest on or any fees with respect to the Term Loan or forgive any
principal, interest (other than default interest) or fees (other than late
charges) with respect to the Term Loan (B) postpone the date fixed for, or
waive, any payment of principal of the Term Loan or of interest on the Term Loan
(other than default interest) or any fees provided for hereunder (other than
late charges or for any termination of any commitment); (C) change the
definition of the term “Required Lenders” or the percentage of Lenders which
shall be required for Lenders to take any action hereunder; (D) release all or
substantially all or any material portion of the Collateral, authorize Borrower
to sell or otherwise dispose of all or substantially all or any material portion
of the Collateral or release any Guarantor of all or any portion of the
Obligations or its guaranty obligations with respect thereto, except, in each
case with respect to this clause (D), as otherwise may be expressly permitted
under this Agreement or the other Loan Documents (including in connection with
any disposition permitted hereunder); (E) amend, waive or otherwise modify this
Section 12.12 or the definitions of the terms used in this Section 12.12 insofar
as the definitions affect the substance of this Section 12.12; (F) consent to
the assignment, delegation or other transfer by any Borrower or any Guarantor of
any of its rights and obligations under any Loan Document or release Borrower or
any Guarantor of its payment obligations under any Loan Document, except, in
each case with respect to this clause (F), pursuant to a merger or consolidation
permitted pursuant to this Agreement; (G) amend any of the provisions of Section
9.4 or amend any of the definitions Pro Rata Share, Term Loan Commitment,
Commitment Percentage or that provide for the Lenders to receive their Pro Rata
Shares of any fees, payments, setoffs or proceeds of Collateral hereunder; (H)
subordinate the Liens granted in favor of Agent securing the Obligations; or (I)
amend any of the provisions of Section 12.10. It is hereby understood and agreed
that all Lenders shall be deemed directly affected by an amendment, waiver or
other modification of the type described in the preceding clauses (C), (D), (E),
(F), (G) and (H) of the preceding sentence;

 

 
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(iv)     the provisions of the foregoing clauses (i), (ii) and (iii) are subject
to the provisions of any interlender or agency agreement among the Agent and
Lenders pursuant to which any Lender may agree to give its consent in connection
with any amendment, waiver or modification of the Loan Documents only in the
event of the unanimous agreement of all Lenders.

 

(b)      Other than as expressly provided for in Section 12.12(a)(i) through
(iii) above, Agent may, if requested by the Required Lenders, from time to
time designate covenants in this Agreement less restrictive by notification to a
representative of the Borrower.

 

12.13     Publicity. Borrower will not directly or indirectly publish, disclose
or otherwise use in any public disclosure, advertising material, promotional
material, press release or interview, any reference to the name, logo or any
trademark of Agent or any Lender or any of their Affiliates or any reference to
this Agreement or the financing evidenced hereby, in any case except as required
by applicable Law, subpoena or judicial or similar order, in which case Borrower
shall endeavor to give Agent prior written notice of such publication or other
disclosure; provided, however, that for the avoidance of doubt, Borrower may
publish the name of Lenders and Agent, the existence of the financing
arrangements referenced under this Agreement, the primary purpose and/or
structure of those arrangements, the amount of credit extended under each
facility, the title and role of each party to this Agreement, and the total
amount of financing evidenced hereby and such other information (including
copies of the Loan Documents) necessary to satisfy the reporting requirements
under the Securities Exchange Act of 1934, as amended. Each Lender and Borrower
hereby authorizes each Lender to publish the name of such Lender and Borrower,
the existence of the financing arrangements referenced under this Agreement, the
primary purpose and/or structure of those arrangements, the amount of credit
extended under each facility, the title and role of each party to this
Agreement, and the total amount of the financing evidenced hereby in any
“tombstone”, comparable advertisement or press release which such Lender elects
to submit for publication. In addition, each Lender and Borrower agrees that
each Lender may provide lending industry trade organizations with information
necessary and customary for inclusion in league table measurements after the
Second Restatement Date. With respect to any of the foregoing authorizations
granted to Lenders, such authorization shall be subject to such Lender providing
Borrower and the other Lenders with an opportunity to review and confer with
such Lender regarding, and approve, the contents of any such tombstone,
advertisement or information, as applicable, prior to its initial submission for
publication, but subsequent publications of the same tombstone, advertisement or
information shall not require Borrower’s approval.

 

12.14     No Strict Construction. The parties hereto have participated jointly
in the negotiation and drafting of this Agreement. In the event an ambiguity or
question of intent or interpretation arises, this Agreement shall be construed
as if drafted jointly by the parties hereto and no presumption or burden of
proof shall arise favoring or disfavoring any party by virtue of the authorship
of any provisions of this Agreement.

 

 

 
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12.15     Amendment and Restatement; No Novation.

 

(a)     On the Second Restatement Date upon the satisfaction of the conditions
precedent in Section 3.1, the Restatement Loan Agreement shall be amended and
restated in its entirety. The Restatement Term Loan outstanding on the Second
Restatement Date shall be reallocated in accordance with the terms set forth in
Section 2.1.

 

(b)     The parties hereto acknowledge and agree that (i) this Agreement and the
other Loan Documents, whether executed and delivered in connection herewith or
otherwise, do not constitute a novation or termination of the Restatement
Obligations under the Restatement Loan Agreement as in effect prior to the
Second Restatement Date and which remain outstanding and are in all respects
continuing (as amended and restated hereby), (ii) the Liens and security
interests as granted under the Restatement Loan Agreement and other Restatement
Loan Documents securing payment of such Restatement Obligations are in all
respects continuing and in full force and effect after giving effect to this
Agreement and the transactions contemplated hereby and all such Liens granted to
the 2011 Agent and the Restatement Agent, as applicable, shall be deemed to
constitute Liens granted to the Agent on behalf of the Lenders under this
Agreement, (iii) references in the Restatement Loan Documents or the Loan
Documents to the “Loan Agreement” shall be deemed to be references to this
Agreement (as the same may be amended, restated, supplemented or otherwise
modified from time to time), and to the extent necessary to effect the
foregoing, each such Loan Document is hereby deemed amended accordingly, (iv)
all of the terms and provisions of the Restatement Loan Agreement shall continue
to apply for the period prior to the Second Restatement Date, including any
determinations of payment dates, interest rates, Events of Default or any amount
that may be payable to the Agent or the Lenders (or their assignees or
replacements hereunder), (v) the Restatement Obligations under the Restatement
Loan Agreement shall continue to be paid or prepaid on or prior to the Second
Restatement Date, and shall from and after the Second Restatement Date continue
to be owing and be subject to the terms of this Agreement, (vi) all references
in the Loan Documents to the “Lenders” or a “Lender” shall be deemed to refer to
such terms as defined in this Agreement, and to the extent necessary to effect
the foregoing, each such Loan Document is hereby deemed amended accordingly and
(vii) any Defaults or Events of Default that are continuing under the
Restatement Loan Agreement shall constitute Defaults or Events of Default under
this Agreement unless the same shall have been specifically waived in writing in
accordance with this Agreement, and to the extent necessary to effect the
foregoing, each such Loan Document is hereby deemed amended accordingly.

 

(c)     The Borrower, Loan Parties, Agent and Lenders acknowledge and agree that
all principal, interest, fees, costs, reimbursable expenses and indemnification
obligations accruing or arising under or in connection with the Restatement Loan
Agreement which remain unpaid and outstanding as of the Second Restatement Date
shall be and remain outstanding and payable as an obligation under this
Agreement and the other Loan Documents.

 

(d)     The parties hereto agree that as of the Second Restatement Date, (i) the
Lenders signatory hereto shall become “Lenders” under this Agreement and the
other Loan Documents and (ii) each Lender shall have the Term Loan Commitment
set forth on Schedule 1 hereto. Borrower hereby directs Agent to apply the
proceeds of the Term Loan made on the Second Restatement Date to the
reallocation on the Second Restatement Date of certain outstanding loans and
obligations of the Borrower owing to the Restatement Lenders and to the payment
of certain fees, expenses and other obligations relating thereto. The parties
hereto have participated jointly in the negotiation and drafting of this
Agreement. In the event an ambiguity or question of intent or interpretation
arises, this Agreement shall be construed as if drafted jointly by the parties
hereto and no presumption or burden of proof shall arise favoring or disfavoring
any party by virtue of the authorship of any provisions of this Agreement.

 

 

 
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13.     AGENT

 

13.1     Appointment and Authorization of Agent. Each Lender hereby irrevocably
appoints, designates and authorizes Agent to take such action on its behalf
under the provisions of this Agreement and each other Loan Document and to
exercise such powers and perform such duties as are expressly delegated to it by
the terms of this Agreement or any other Loan Document, together with such
powers as are reasonably incidental thereto. Notwithstanding any provision to
the contrary contained elsewhere herein or in any other Loan Document, Agent
shall not have any duties or responsibilities, except those expressly set forth
herein, nor shall Agent have or be deemed to have any fiduciary relationship
with any Lender or participant, and no implied covenants, functions,
responsibilities, duties, obligations or liabilities shall be read into this
Agreement or any other Loan Document or otherwise exist against Agent. Without
limiting the generality of the foregoing sentence, the use of the term “agent”
herein and in the other Loan Documents with reference to Agent is not intended
to connote any fiduciary or other implied (or express) obligations arising under
agency doctrine of any applicable Law. Instead, such term is used merely as a
matter of market custom, and is intended to create or reflect only an
administrative relationship between independent contracting parties. Without
limiting the generality of the foregoing, each Lender acknowledges that it has
received a copy of the Subordination Agreement, consents to and authorizes
Agent’s execution and delivery thereof on behalf of such Lender and Agent’s
authority to perform its duties and obligations thereunder, and further agrees
to be bound by the terms and provisions thereof.

 

13.2     Delegation of Duties. Agent may execute any of its duties under this
Agreement or any other Loan Document by or through its, or its Affiliates’,
agents, employees or attorneys-in-fact and shall be entitled to obtain and rely
upon the advice of counsel and other consultants or experts concerning all
matters pertaining to such duties. Agent shall not be responsible for the
negligence or misconduct of any agent or attorney-in-fact that it selects in the
absence of gross negligence or willful misconduct.

 

13.3     Liability of Agent. Except as otherwise provided herein, no
Agent-Related Person shall (a) be liable for any action taken or omitted to be
taken by any of them under or in connection with this Agreement or any other
Loan Document or the transactions contemplated hereby (except for its own gross
negligence or willful misconduct in connection with its duties expressly set
forth herein), or (b) be responsible in any manner to any Lender or participant
for any recital, statement, representation or warranty made by Borrower or any
officer thereof, contained herein or in any other Loan Document, or in any
certificate, report, statement or other document referred to or provided for in,
or received by Agent under or in connection with, this Agreement or any other
Loan Document, or the validity, effectiveness, genuineness, enforceability or
sufficiency of this Agreement or any other Loan Document, or for any failure of
Borrower or any other party to any Loan Document to perform its obligations
hereunder or thereunder. No Agent-Related Person shall be under any obligation
to any Lender or participant to ascertain or to inquire as to the observance or
performance of any of the agreements contained in, or conditions of, this
Agreement or any other Loan Document, or to inspect the properties, books or
records of Borrower or any Affiliate thereof.

 

 

 
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13.4     Reliance by Agent. Agent shall be entitled to rely, and shall be fully
protected in relying, upon any writing, communication, signature, resolution,
representation, notice, consent, certificate, affidavit, letter, telegram,
facsimile, telex or telephone message, electronic mail message, statement or
other document or conversation believed by it to be genuine and correct and to
have been signed, sent or made by the proper Person or Persons, and upon advice
and statements of legal counsel (including counsel to Borrower), independent
accountants and other experts selected by Agent. Agent shall be fully justified
in failing or refusing to take any action under any Loan Document unless it
shall first receive such advice or concurrence of all Lenders as it deems
appropriate and, if it so requests, it shall first be indemnified to its
satisfaction by the Lenders against any and all liability and expense which may
be incurred by it by reason of taking or continuing to take any such action.
Agent shall in all cases be fully protected in acting, or in refraining from
acting, under this Agreement or any other Loan Document in accordance with a
request or consent of all Lenders and such request and any action taken or
failure to act pursuant thereto shall be binding upon all the Lenders.

 

13.5     Notice of Default. Agent shall not be deemed to have knowledge or
notice of the occurrence of any Default and/or Event of Default, unless Agent
shall have received written notice from a Lender or Borrower, describing such
default or Event of Default. Agent will notify the Lenders of its receipt of any
such notice. Agent shall take such action with respect to an Event of Default as
may be directed in writing by the Required Lenders in accordance with Section
9(a); provided, however, that while an Event of Default has occurred and is
continuing, Agent may (but shall not be obligated to) take such action, or
refrain from taking such action, with respect to such Event of Default as Agent
shall deem advisable or in the best interest of the Lenders, including without
limitation, satisfaction of other security interests, liens or encumbrances on
the Collateral not permitted under the Loan Documents, payment of taxes on
behalf of Borrower, payments to landlords, warehouseman, bailees and other
Persons in possession of the Collateral and other actions to protect and
safeguard the Collateral, and actions with respect to insurance claims for
casualty events affecting Borrower and/or the Collateral.

 

13.6     Credit Decision; Disclosure of Information by Agent. Each Lender
acknowledges that no Agent-Related Person has made any representation or
warranty to it, and that no act by Agent hereafter taken, including any consent
to and acceptance of any assignment or review of the affairs of Borrower or any
Affiliate thereof, shall be deemed to constitute any representation or warranty
by any Agent-Related Person to any Lender as to any matter, including whether
Agent-Related Persons have disclosed material information in their possession.
Each Lender represents to Agent that it has, independently and without reliance
upon any Agent-Related Person and based on such documents and information as it
has deemed appropriate, made its own appraisal of, and investigation into, the
business, prospects, operations, property, financial and other condition and
creditworthiness of Borrower and its respective Subsidiaries, and all applicable
bank or other regulatory Laws relating to the transactions contemplated hereby,
and made its own decision to enter into this Agreement and to extend credit to
Borrower hereunder. Each Lender also represents that it will, independently and
without reliance upon any Agent-Related Person and based on such documents and
information as it shall deem appropriate at the time, continue to make its own
credit analysis, appraisals and decisions in taking or not taking action under
this Agreement and the other Loan Documents, and to make such investigations as
it deems necessary to inform itself as to the business, prospects, operations,
property, financial and other condition and creditworthiness of Borrower. Except
for notices, reports and other documents expressly required to be furnished to
the Lenders by Agent herein, Agent shall not have any duty or responsibility to
provide any Lender with any credit or other information concerning the business,
prospects, operations, property, financial and other condition or
creditworthiness of Borrower or any of its Affiliates which may come into the
possession of any Agent-Related Person.

 

 

 
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13.7     Indemnification of Agent. Whether or not the transactions contemplated
hereby are consummated, each Lender shall, severally and pro rata based on its
respective Pro Rata Share, indemnify upon demand each Agent-Related Person (to
the extent not reimbursed by or on behalf of Borrower and without limiting the
obligation of Borrower to do so), and hold harmless each Agent-Related Person
from and against any and all Indemnified Liabilities (which shall not include
legal expenses of Agent incurred in connection with the closing of the
transactions contemplated by this Agreement) incurred by it; provided, however,
that no Lender shall be liable for the payment to any Agent-Related Person of
any portion of such Indemnified Liabilities to the extent determined in a
judgment by a court of competent jurisdiction to have resulted from such
Agent-Related Person’s own gross negligence or willful misconduct; provided,
however, that no action taken in accordance with the directions of the Required
Lenders shall be deemed to constitute gross negligence or willful misconduct for
purposes of this Section 13.7. Without limitation of the foregoing, each Lender
shall, severally and pro rata based on its respective Pro Rata Share, reimburse
Agent upon demand for its ratable share of any costs or out-of-pocket expenses
(including Lenders’ Expenses incurred after the closing of the transactions
contemplated by this Agreement) incurred by Agent (in its capacity as Agent, and
not as a Lender) in connection with the preparation, execution, delivery,
administration, modification, amendment or enforcement (whether through
negotiations, legal proceedings or otherwise) of, or legal advice in respect of
rights or responsibilities under, this Agreement, any other Loan Document, or
any document contemplated by or referred to herein, to the extent that Agent is
not reimbursed for such expenses by or on behalf of Borrower. The undertaking in
this Section 13.7 shall survive the payment in full of the Obligations, the
termination of this Agreement and the resignation of Agent.

 

13.8     Agent in its Individual Capacity. With respect to its Credit
Extensions, MidCap shall have the same rights and powers under this Agreement as
any other Lender and may exercise such rights and powers as though it were not
Agent, and the terms “Lender” and “Lenders” include MidCap in its individual
capacity.

 

13.9     Successor Agent.

 

(a)     Agent may at any time assign its rights, powers, privileges and duties
hereunder to (i) another Lender, or (ii) any Person to whom Agent, in its
capacity as a Lender, has assigned (or will assign, in conjunction with such
assignment of agency rights hereunder) 50% or more of its Loan, in each case
without the consent of the Lenders or Borrowers. Following any such assignment,
Agent shall give notice to the Lenders and Borrowers. An assignment by Agent
pursuant to this subsection (a) shall not be deemed a resignation by Agent for
purposes of subsection (b) below.

 

 

 
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(b)     Without limiting the rights of Agent to designate an assignee pursuant
to subsection (a) above, Agent may at any time give notice of its resignation to
the Lenders and Borrowers. Upon receipt of any such notice of resignation,
Required Lenders shall have the right to appoint a successor Agent. If no such
successor shall have been so appointed by Required Lenders and shall have
accepted such appointment within ten (10) Business Days after the retiring Agent
gives notice of its resignation, then the retiring Agent may, on behalf of the
Lenders, appoint a successor Agent; provided, however, that if Agent shall
notify Borrowers and the Lenders that no Person has accepted such appointment,
then such resignation shall nonetheless become effective in accordance with such
notice from Agent that no Person has accepted such appointment and, from and
following delivery of such notice, (i) the retiring Agent shall be discharged
from its duties and obligations hereunder and under the other Loan Documents,
and (ii) all payments, communications and determinations provided to be made by,
to or through Agent shall instead be made by or to each Lender directly, until
such time as Required Lenders appoint a successor Agent as provided for above in
this subsection (b).

 

(c)     Upon (i) an assignment permitted by subsection (a) above, or (ii) the
acceptance of a successor’s appointment as Agent pursuant to subsection (b)
above, such successor shall succeed to and become vested with all of the rights,
powers, privileges and duties of the retiring (or retired) Agent, and the
retiring Agent shall be discharged from all of its duties and obligations
hereunder and under the other Loan Documents (if not already discharged
therefrom as provided above in this subsection (c)). The fees payable by
Borrowers to a successor Agent shall be the same as those payable to its
predecessor unless otherwise agreed between Borrower and such successor. After
the retiring Agent’s resignation hereunder and under the other Loan Documents,
the provisions of this Section 13 shall continue in effect for the benefit of
such retiring Agent and its sub-agents in respect of any actions taken or
omitted to be taken by any of them while the retiring Agent was acting or was
continuing to act as Agent.

 

13.10     Agent May File Proofs of Claim. In case of the pendency of any
receivership, insolvency, liquidation, bankruptcy, reorganization, arrangement,
adjustment, composition or other judicial proceeding relative to Borrower, Agent
(irrespective of whether the principal of any Loan, shall then be due and
payable as herein expressed or by declaration or otherwise and irrespective of
whether Agent shall have made any demand on Borrower) shall be entitled and
empowered, by intervention in such proceeding or otherwise:

 

(a)     to file and prove a claim for the whole amount of the principal and
interest owing and unpaid in respect of the Credit Extensions and all other
Obligations that are owing and unpaid and to file such other documents as may be
necessary or advisable in order to have the claims of the Lenders and Agent
(including any claim for the reasonable compensation, expenses, disbursements
and advances of the Lenders and Agent and their respective agents and counsel
and all other amounts due the Lenders and Agent allowed in such judicial
proceeding); and

 

 

 
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(b)     to collect and receive any monies or other property payable or
deliverable on any such claims and to distribute the same;

 

and any custodian, receiver, assignee, trustee, liquidator, sequestrator or
other similar official in any such judicial proceeding is hereby authorized by
each Lender to make such payments to Agent and, in the event that Agent shall
consent to the making of such payments directly to the Lenders, to pay to Agent
any amount due for the reasonable compensation, expenses, disbursements and
advances of Agent and its agents and counsel, and any other amounts due Agent
under Section 2.4(d). To the extent that Agent fails timely to do so, each
Lender may file a claim relating to such Lender’s claim.

 

13.11     Collateral and Guaranty Matters. The Lenders irrevocably authorize
Agent, at its option and in its discretion, to release any Guarantor and any
Lien on any Collateral granted to or held by Agent under any Loan Document (a)
upon the date that all Obligations due hereunder have been fully and
indefeasibly paid in full and no Term Loan Commitments or other obligations of
any Lender to provide funds to Borrower under this Agreement remain outstanding,
(b) that is transferred or to be transferred as part of or in connection with
any Transfer permitted hereunder or under any other Loan Document, or (c) as
approved in accordance with Section 12.12. Upon request by Agent at any time,
all Lenders will confirm in writing Agent’s authority to release its interest in
particular types or items of Property, pursuant to this Section 13.11.

 

13.12     Cooperation of Borrower. If necessary, Borrower agrees to (a) execute
any documents (including new Secured Promissory Notes) reasonably required to
effectuate and acknowledge each assignment of a Term Loan Commitment or Loan to
an assignee in accordance with Section 12.1, (b) make Borrower’s management
available to meet with Agent and prospective participants and assignees of Term
Loan Commitments or Credit Extensions and (c) assist Agent or the Lenders in the
preparation of information relating to the financial affairs of Borrower as any
prospective participant or assignee of a Term Loan Commitment or Term Loan
reasonably may request. Subject to the provisions of Section 12.9 Borrower
authorizes each Lender to disclose to any prospective participant or assignee of
a Term Loan Commitment, any and all information in such Lender’s possession
concerning Borrower and its financial affairs which has been delivered to such
Lender by or on behalf of Borrower pursuant to this Agreement, or which has been
delivered to such Lender by or on behalf of Borrower in connection with such
Lender’s credit evaluation of Borrower prior to entering into this Agreement.

 

14.     DEFINITIONS

 

As used in this Agreement, the following terms have the following meanings:

 

“2011 Agent” has the meaning given to it in the preamble to this Agreement.

 

“2011 Closing Date” has the meaning given it in the preamble of this Agreement.

 

“2011 Lenders” has the meaning given to it in the preamble to this Agreement.

 

“2011 Loan Agreement” has the meaning given to it in the preamble to this
Agreement.

 

 

 
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“Access Agreement” means a landlord consent, bailee letter or warehouseman’s
letter, in form and substance reasonably satisfaction to Agent, in favor of
Agent executed by such landlord, bailee or warehouseman, as applicable, for any
third party location.

 

“Account” means any “account”, as defined in the Code, with such additions to
such term as may hereafter be made, and includes, without limitation, all
accounts receivable and other sums owing to Borrower.

 

“Account Debtor” means any “account debtor”, as defined in the Code, with such
additions to such term as may hereafter be made.

 

“Affiliate” means, with respect to any Person, a Person that owns or controls
directly or indirectly the Person, any Person that controls or is controlled by
or is under common control with the Person, and each of that Person’s senior
executive officers, directors, partners and, for any Person that is a limited
liability company, that Person’s managers and members.

 

“Agent” means, MidCap, not in its individual capacity, but solely in its
capacity as agent on behalf of and for the benefit of the Lenders.

 

“Agent-Related Person” means the Agent, together with its Affiliates, and the
officers, directors, employees, agents, advisors, auditors and attorneys-in-fact
of such Persons; provided, however, that no Agent-Related Person shall be an
Affiliate of Borrower.

 

“Agreement” has the meaning given it in the preamble of this Agreement.

 

“Amortization Date” means May 15, 2014.

 

“Amortization Payment” means each payment identified as an Amortization Payment
under the heading “Amortization Payment” in the table set forth in Schedule
2.2(b) to this Agreement.

 

“Amortization Payment Date” means each date identified as an Amortization
Payment Date under the heading “Amortization Payment Date” in the table set
forth in Schedule 2.2(b) to this Agreement.

 

“Anti-Terrorism Laws” means any Laws relating to terrorism or money laundering,
including Executive Order No. 13224 (effective September 24, 2001), the USA
PATRIOT Act, the Laws comprising or implementing the Bank Secrecy Act, and the
Laws administered by OFAC.

 

“Approved Drug” has the meaning given it in the definition of “Sale Compound”.

 

“Approved Fund” means any (a) investment company, fund, trust, securitization
vehicle or conduit that is (or will be) engaged in making, purchasing, holding
or otherwise investing in commercial loans and similar extensions of credit in
the Ordinary Course of Business, or (b) any Person (other than a natural person)
which temporarily warehouses loans for any Lender or any entity described in the
preceding clause (a) and that, with respect to each of the preceding clauses (a)
and (b), is administered or managed by (i) a Lender, (ii) an Affiliate of a
Lender or (iii) a Person (other than a natural person) or an Affiliate of a
Person (other than a natural person) that administers or manages a Lender.

 

 
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“Assignment Agreement” has the meaning given it in Section 12.1.

 

“Blocked Person” means: (a) any Person listed in the annex to, or is otherwise
subject to the provisions of, Executive Order No. 13224, (b) a Person owned or
controlled by, or acting for or on behalf of, any Person that is listed in the
annex to, or is otherwise subject to the provisions of, Executive Order No.
13224, (c) a Person with which any Lender is prohibited from dealing or
otherwise engaging in any transaction by any Anti-Terrorism Law, (d) a Person
that commits, threatens or conspires to commit or supports “terrorism” as
defined in Executive Order No. 13224, or (e) a Person that is named a “specially
designated national” or “blocked person” on the most current list published by
OFAC or other similar list.

 

“Borrower” has the meaning given it in the preamble of this Agreement.

 

“Borrower’s Books” means all of Borrower’s books and records, including ledgers,
federal and state tax returns, records regarding Borrower’s assets or
liabilities, the Collateral, business operations or financial condition, and all
computer programs or storage or any equipment containing such information.

 

“Borrowing Resolutions” means, with respect to any Person, those resolutions, in
form and substance satisfactory to Agent, adopted by such Person’s Board of
Directors or other appropriate governing body and delivered by such Person to
Agent approving the Loan Documents to which such Person is a party and the
transactions contemplated thereby, as well as any other approvals as may be
necessary or desired to approve the entering into the Loan Documents or the
consummation of the transactions contemplated thereby or in connection
therewith.

 

“Business Day” means any day that is not a Saturday, Sunday or a day on which
Agent is closed for business.

 

“Cash Equivalents” means (a) marketable direct obligations issued or
unconditionally guaranteed by the United States or any agency or any State
thereof having maturities of not more than one (1) year from the date of
acquisition, (b) commercial paper maturing no more than one (1) year after its
creation and having the highest rating from either Standard & Poor’s Ratings
Group or Moody’s Investors Service, Inc., (c) certificates of deposit issued
maturing no more than one (1) year after issue, and (d) money market funds at
least ninety-five percent (95%) of the assets of which constitute Cash
Equivalents of the kinds described in clauses (a) through (b) of this
definition. For the avoidance of doubt, the direct purchase by Borrower,
co-borrower, or any subsidiary of Borrower of any Auction Rate Securities, or
purchasing participations in, or entering into any type of swap or other
derivative transaction, or otherwise holding or engaging in any ownership
interest in any type of Auction Rate Security by Borrower, co-borrower, or any
subsidiary of Borrower shall be conclusively determined by the Lenders as an
ineligible Cash Equivalent, and any such transaction shall expressly violate
each other provision of this agreement governing Permitted Investments.
Notwithstanding the foregoing, Cash Equivalents does not include, and each
Borrower and Subsidiary is prohibited from purchasing, purchasing participations
in, entering into any type of swap or other equivalent derivative transaction,
or otherwise holding or engaging in any ownership interest in any type of debt
instrument, including, without limitation, any corporate or municipal bonds with
a long-term nominal maturity for which the interest rate is reset through a
dutch auction and more commonly referred to as an auction rate security.

 

 

 
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“Change in Control” means any event, transaction, or occurrence as a result of
which (a) any “person” (as such term is defined in Sections 3(a)(9) and 13(d)(3)
of the Exchange Act), other than (i) a trustee or other fiduciary holding
securities under an employee benefit plan of Borrower or (ii) Fredric N.
Eshelman, is or becomes, or has entered into a contract which upon consummation
shall make such person, a beneficial owner (within the meaning Rule 13d-3
promulgated under the Exchange Act), directly or indirectly, of securities of
Borrower, representing forty percent (40%) or more of the combined voting power
of Borrower’s then outstanding securities; (b) any Borrower ceases to own,
directly or indirectly, (100%) of the capital stock of any of its Subsidiaries;
or (c) during any period of twelve consecutive calendar months, individuals who
at the beginning of such period constituted the Board of Directors of Borrower
(together with any new directors whose election by the Board of Directors of
Borrower was approved by a vote of not less than two-thirds of the directors
then still in office who either were directors at the beginning of such period
or whose election or nomination for election was previously so approved) cease
for any reason other than death or disability to constitute a majority of the
directors then in office.

 

“Claims” has the meaning given it in Section 12.2.

 

“Code” means the Uniform Commercial Code in effect on the date hereof, as the
same may, from time to time, be enacted and in effect in the State of Maryland;
provided, however, that to the extent that the Code is used to define any term
herein or in any Loan Document and such term is defined differently in different
Articles or Divisions of the Code, the definition of such term contained in
Article or Division 9 shall govern; and provided, further, that in the event
that, by reason of mandatory provisions of Law, any or all of the attachment,
perfection, or priority of, or remedies with respect to, Agent’s Lien on any
Collateral is governed by the Uniform Commercial Code in effect in a
jurisdiction other than the State of Maryland, the term “Code” shall mean the
Uniform Commercial Code as enacted and in effect in such other jurisdiction
solely for purposes of the provisions thereof relating to such attachment,
perfection, priority, or remedies and for purposes of definitions relating to
such provisions.

 

“Collateral” means all property, now existing or hereafter acquired, mortgaged
or pledged to, or purported to be subjected to a Lien in favor of Agent, for the
benefit of Agent and Lenders, pursuant to this Agreement and the other Loan
Documents, including, without limitation, all of the property described in
Exhibit A hereto.

 

“Collateral Account” means any Deposit Account, Securities Account or Commodity
Account.

 

“Commitment Percentage” means, as to any Lender, the percentage set forth
opposite such Lender’s name on Schedule 1, as amended from time to time.

 

 

 
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“Commodity Account” means any “commodity account”, as defined in the Code, with
such additions to such term as may hereafter be made.

 

“Communication” has the meaning given it in Section 10.

 

“Compliance Certificate” means a certificate, duly executed by an authorized
officer of Borrower, appropriately completed and substantially in the form of
Exhibit C.

 

“Contingent Obligation” means, for any Person, any direct or indirect liability,
contingent or not, of that Person for (a) any indebtedness, lease, dividend,
letter of credit or other obligation of another such as an obligation directly
or indirectly guaranteed, endorsed, co-made, discounted or sold with recourse by
that Person, or for which that Person is directly or indirectly liable; (b) any
obligations for undrawn letters of credit for the account of that Person; and
(c) all obligations from any interest rate, currency or commodity swap
agreement, interest rate cap or collar agreement, or other agreement or
arrangement designated to protect a Person against fluctuation in interest
rates, currency exchange rates or commodity prices; but “Contingent Obligation”
does not include endorsements in the Ordinary Course of Business. The amount of
a Contingent Obligation is the stated or determined amount of the primary
obligation for which the Contingent Obligation is made or, if not determinable,
the maximum reasonably anticipated liability for it determined by the Person in
good faith; but the amount may not exceed the maximum of the obligations under
any guarantee or other support arrangement.

 

“Control Agreement” means any control agreement entered into among the
depository institution at which Borrower maintains a Deposit Account or the
securities intermediary or commodity intermediary at which Borrower maintains a
Securities Account or a Commodity Account, Borrower, and Agent pursuant to which
Agent obtains control (within the meaning of the Code) for the benefit of the
Lenders over such Deposit Account, Securities Account or Commodity Account.

 

“Credit Extension” means any Term Loan or any other extension of credit by Agent
or the Lenders for Borrower’s benefit.

 

“DEA” means the Drug Enforcement Administration of the United States of America,
and any successor agency thereof.

 

“Default” means any event which with notice or passage of time or both, would
constitute an Event of Default.

 

“Default Rate” has the meaning given it in Section 2.3(c).

 

“Deposit Account” means any “deposit account” as defined in the Code with such
additions to such term as may hereafter be made.

 

“Designated Deposit Account” means Borrower’s deposit account, account number
[*],

7 maintained with Silicon Valley Bank and over which Agent has been granted
control for the ratable benefit of the Lenders.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
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“Development Compound” means any therapeutic compound being tested by any
Borrower or any of its Subsidiaries, including without limitation, those drug
compounds set forth on Schedule 5.11, for use in Phase I, Phase II or Phase III
trials; provided, in the event Borrower fails to comply with the obligations
under Section 6.2(d) to give notice to Agent and update Schedule 5.11 with
respect to any new Development Compound, any such improperly undisclosed
Development Compound shall be deemed to be included in this definition.

 

“Development Inventory₁ means the Borrower’s inventory of Development Compounds.

 

“Dollars,” “dollars” and “$” each means lawful money of the United States.

 

“Domestic Subsidiary” means any Subsidiary incorporated under the laws of any
State of the United States or the District of Columbia.

 

“Drug Application” means a new drug application, an abbreviated drug
application, or a product license application for any Product, as appropriate,
as those terms are defined in the FDCA.

 

“Eligible Assignee” means (a) a Lender, (b) an Affiliate of a Lender, (c) an
Approved Fund, and (d) any other Person (other than a natural person) approved
by Agent; provided, however, that notwithstanding the foregoing, “Eligible
Assignee” shall not include Borrower, any Guarantor or any of Borrower’s or any
Guarantor’s Affiliates or Subsidiaries. Notwithstanding the foregoing, in
connection with assignments by a Lender due to a forced divestiture at the
request of any regulatory agency, the restrictions set forth herein shall not
apply and Eligible Assignee shall mean any Person or party becoming an assignee
incident to such forced divestiture.

 

“Eluxadoline Submission Event” means the submission to the FDA of a new drug
application for Eluxadoline, which application shall be in form and substance
sufficient to satisfy FDA requirements for a determination of filing by the FDA
pursuant to 21 CFR 314.50 and 21 CFR 314.101(a)(1).

 

“Equipment” means all “equipment”, as defined in the Code, with such additions
to such term as may hereafter be made, and includes without limitation all
machinery, fixtures, goods, vehicles (including motor vehicles and trailers),
and any interest in any of the foregoing.

 

“ERISA” means the Employee Retirement Income Security Act of 1974, and all
regulations promulgated thereunder.

 

“European Union” means the European Union and/or the countries that make up the
European Union as of the Second Restatement Date.

 

“Event of Default” has the meaning given it in Section 8.

 

 

 
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“FDA” means the Food and Drug Administration of the United States of America, or
any successor entity thereto.

 

“FDCA” means the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C.
Section 301 et seq., and all regulations promulgated thereunder.

 

“Fee Letter” means that certain Fee Letter, dated as of the Second Restatement
Date by and among Borrower, Agent and the other parties thereto, as the same may
be amended, restated, supplemented or otherwise modified from time to time.

 

“Final Payment” means a payment (in addition to and not a substitution for the
regular monthly payments of accrued interest or the scheduled quarterly
Amortization Payments) due on the earlier to occur of (a) the Maturity Date, (b)
the acceleration of any Term Loan, and (c) the prepayment of the Term Loan
pursuant to Section 2.2(c) or (d), equal to the Term Loan Commitments multiplied
by the Final Payment Percentage.

 

“Final Payment Percentage” means three and one half of one percent (3.5%).

 

“Foreign Subsidiary” means, with respect to any Person, a Subsidiary of such
Person that is a “controlled foreign corporation” under Section 957 of the IRC.

 

“Funding Date” means any date on which a Credit Extension is made to or on
account of Borrower which shall be a Business Day.

 

“GAAP” means generally accepted accounting principles set forth in the opinions
and pronouncements of the Accounting Principles Board of the American Institute
of Certified Public Accountants and statements and pronouncements of the
Financial Accounting Standards Board or in such other statements by such other
Person as may be approved by a significant segment of the accounting profession
in the United States, which are applicable to the circumstances as of the date
of determination.

 

“General Intangibles” means all “general intangibles”, as defined in the Code,
with such additions to such term as may hereafter be made, and includes without
limitation, all copyright rights, copyright applications, copyright
registrations and like protections in each work of authorship and derivative
work, whether published or unpublished, any patents, trademarks, service marks
and, to the extent permitted under applicable Law, any applications therefor,
whether registered or not, any trade secret rights, including any rights to
unpatented inventions, payment intangibles, royalties, contract rights,
goodwill, franchise agreements, purchase orders, customer lists, route lists,
telephone numbers, domain names, claims, income and other tax refunds, security
and other deposits, options to purchase or sell real or personal property,
rights in all litigation presently or hereafter pending (whether in contract,
tort or otherwise), insurance policies (including without limitation key man,
property damage, and business interruption insurance), payments of insurance and
rights to payment of any kind.

 

“Global Reaffirmation Agreement” means that certain Omnibus Amendment and
Reaffirmation Agreement, dated as of the Restatement Date, among Borrower and
Agent, as the same may be amended, restated, replaced, supplemented or otherwise
modified from time to time.

 

 

 
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“Governmental Approval” means any consent, authorization, approval, order,
license, franchise, permit, certificate, accreditation, registration, filing or
notice, of, issued by, from or to, or other act by or in respect of, any
Governmental Authority.

 

“Governmental Authority” means any nation or government, any state or other
political subdivision thereof, any agency, authority, instrumentality,
regulatory body, court, central bank or other entity exercising executive,
legislative, judicial, taxing, regulatory or administrative functions of or
pertaining to government, any securities exchange and any self-regulatory
organization.

 

“Guarantor” means any present or future guarantor of the Obligations.

 

“Indebtedness” means (a) indebtedness for borrowed money or the deferred price
of property or services, such as reimbursement and other obligations for surety
bonds and letters of credit, (b) obligations evidenced by notes, bonds,
debentures or similar instruments, (c) capital lease obligations, (d) Contingent
Obligations, (e) equity securities of such Person subject to repurchase or
redemption other than at the sole option of such Person, (f) obligations secured
by a Lien on any asset of such Person, whether or not such obligation is
otherwise an obligation of such Person, (g) “earnouts”, purchase price
adjustments, profit sharing arrangements, deferred purchase money amounts and
similar payment obligations of such Person arising out of purchase and sale
contracts, (h) off-balance sheet liabilities and/or multiemployer plan
liabilities of such Person, and (i) payment obligations arising under bonus,
deferred compensation, incentive compensation or similar arrangements, other
than those arising in the Ordinary Course of Business.

 

“Indemnified Liabilities” has the meaning given it in Section 12.2.

 

“Indemnified Person” has the meaning given it in Section 12.2.

 

“Insolvency Proceeding” means any proceeding by or against any Person under the
United States Bankruptcy Code, or any other bankruptcy or insolvency Law,
including assignments for the benefit of creditors, compositions, extensions
generally with its creditors, or proceedings seeking reorganization,
arrangement, or other relief.

 

“Intellectual Property” includes without limitation, all copyright rights,
copyright applications, copyright registrations and like protections in each
work of authorship and derivative work, whether published or unpublished, any
patents, patent applications and like protections, including improvements,
divisions, continuations, renewals, reissues, extensions, and
continuations-in-part of the same, trademarks, trade names, service marks, mask
works, rights of use of any name, domain names, or any other similar rights, any
applications therefor, whether registered or not, know-how, operating manuals,
trade secret rights, clinical and non-clinical data, rights to unpatented
inventions, and any claims for damage by way of any past, present, or future
infringement of any of the foregoing.

 

“Interest Payment Date” means the first calendar day of each calendar month.

 

 

 
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“Inventory” means all “inventory”, as defined in the Code, with such additions
to such term as may hereafter be made, and includes without limitation all
merchandise, raw materials, parts, supplies, packing and shipping materials,
work in process and finished products, including without limitation such
inventory as is temporarily out of Borrower’s custody or possession or in
transit and including any returned goods and any documents of title representing
any of the above.

 

“Investment” means any beneficial ownership interest in any Person (including
stock, partnership interest or other securities), and any loan, advance or
capital contribution to any Person.

 

“IRC” means the Internal Revenue Code of 1986.

 

“Laws” means any and all federal, state, provincial, territorial, local and
foreign statutes, laws, judicial decisions, regulations, guidances, guidelines,
ordinances, rules, judgments, orders, decrees, codes, plans, injunctions,
permits, concessions, grants, franchises, governmental agreements and
governmental restrictions, whether now or hereafter in effect, which are
applicable to any Borrower in any particular circumstance.

 

“Lender” means any one of the Lenders.

 

“Lenders” means the Persons identified on Schedule 1 hereto, and each assignee
that becomes a party to this Agreement pursuant to Section 12.1.

 

“Lenders’ Expenses” means all documented, out-of-pocket due diligence fees and
expenses and other fees, costs, and expenses (including reasonable attorneys’
fees and expenses) of Agent and Lenders for preparing, amending, negotiating,
administering, defending and enforcing this Agreement and the other Loan
Documents (including, without limitation, those incurred in connection with
appeals or Insolvency Proceedings) or otherwise incurred by Agent or the Lenders
in connection with the Loan Documents.

 

“Lien” means a claim, mortgage, deed of trust, levy, charge, pledge, security
interest or other encumbrance of any kind, whether voluntarily incurred or
arising by operation of Law or otherwise against any property.

 

“Loan Documents” means, collectively, this Agreement, the Perfection
Certificate, the Pledge Agreement, the Subordination Agreement, the Fee Letter,
the Global Reaffirmation Agreement, the Second Global Reaffirmation Agreement,
the Secured Promissory Notes and any other note, or notes or guaranties executed
by Borrower or any Guarantor in connection with the indebtedness governed by
this Agreement, and any other present or future agreement between Borrower
and/or for the benefit of the Lenders and Agent in connection with this
Agreement, all as amended, restated, supplemented or otherwise modified.

 

“Loan Party” means Borrower and each Guarantor.

 

“Material Adverse Change” means (a) a material impairment in the perfection or
priority of the Agent’s Lien in the Collateral or in the value of such
Collateral, taken as a whole; (b) a material adverse change in the business,
operations, or condition (financial or otherwise) or prospects of Borrower,
taken as a whole; or (c) a material impairment of the prospect of repayment of
any portion of the Obligations.

 

 

 
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“Material Intellectual Property” means Borrower’s Intellectual Property and
license agreements that are material to the condition (financial or other),
business or operations of Borrower, as determined by Agent. For purposes hereof,
over the counter software that is commercially available to the public shall not
be deemed “material.”

 

“Maturity Date” means the earlier of (i) the date on which payment in full of
the Obligations is made and (ii) October 1, 2018.

 

“Nesina” means the product containing the compound alogliptin as the only active
pharmaceutical ingredient, which is used to treat Type 2 diabetes.

 

“Nesina Japan Sales” means the “Japan Net Sales’ as such term is defined in the
Nesina License Agreement as in effect on the Second Restatement Date without
giving effect to any future amendments, restatements, supplements or other
modifications thereto.

 

“Nesina License Agreement” means that certain Agreement dated July 13, 2005
between Takeda San Diego, Inc. (“TSD”), Takeda Pharmaceutical Company Limited
(“TPC”), Development Partners LLC (“DP”) and Pharmaceutical Product Development,
Inc. (“PPD, Inc.”), as amended by that certain Amendment No. 1 to the Agreement,
dated as of October 10, 2005, by and among TSD, TPC, DP and PPD, Inc. Borrower
hereby represents and warrants that, as of the Second Restatement Date, there
are no other amendments, restatements, supplements or other modifications to the
Nesina License Agreement other than as set forth in this definition.

 

“Nesina Royalty Payment” means the sum of all royalty payments owing to Borrower
from Takeda under and pursuant to the Nesina License Agreement as in effect on
the date hereof.

 

“Nesina Transaction Documents” means, collectively, the Nesina License Agreement
and any other agreements entered into in connection therewith, but excluding
ancillary agreements related to research and development, medical affairs,
regulatory activity, investor relations, corporate communications and
commercialization that are entered into in the Ordinary Course of Business and
do not change the economic or license rights associated with the Nesina License
Agreement and other Nesina Transaction Documents.

 

“Obligations” means all of Borrower’s obligations to pay when due any debts,
principal, interest, Lenders’ Expenses, the Prepayment Fee, the Final Payment,
and other amounts Borrower owes the Lenders now or later, under this Agreement
or the other Loan Documents, including, without limitation, interest accruing
after Insolvency Proceedings begin (whether or not allowed) and debts,
liabilities, or obligations of Borrower assigned to the Lenders and/or Agent,
and the performance of Borrower’s duties under the Loan Documents.

 

“OFAC” means the U.S. Department of Treasury Office of Foreign Assets Control.

 

“OFAC Lists” means, collectively, the Specially Designated Nationals and Blocked
Persons List maintained by OFAC pursuant to Executive Order No. 13224, 66 Fed.
Reg. 49079 (Sept. 25, 2001) and/or any other list of terrorists or other
restricted Persons maintained pursuant to any of the rules and regulations of
OFAC or pursuant to any other applicable Executive Orders.

 

 

 
48

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“Operating Documents” means, for any Person, (a) such Person’s formation
documents, as certified with the Secretary of State of such Person’s state of
formation on a date that is no earlier than 30 days prior to the Second
Restatement Date, (b)(i) if such Person is a corporation, its bylaws in current
form, (ii) if such Person is a limited liability company, its limited liability
company agreement (or similar agreement), or (iii) if such Person is a
partnership, its partnership agreement (or similar agreement), and (c) any other
organizational documents of Borrower, in each case for clauses (a) through (c),
together with all current amendments or modifications thereto and corporate,
company, partner, member or shareholder resolutions associated therewith.

 

“Ordinary Course of Business” means, in respect of any transaction involving any
Loan Party, the ordinary course of business of such Loan Party, as conducted by
such Loan Party in accordance with past practices.

 

“Perfection Certificate” has the meaning given it in Section 5.1.

 

“Permits” means licenses, certificates, accreditations, product clearances or
approvals, provider numbers or provider authorizations, marketing
authorizations, other authorizations, registrations, permits, consents and
approvals required in connection with the conduct of Borrower’s or any
Subsidiary’s business or to comply with any applicable Laws, including, without
limitation, drug listings and drug establishment registrations under 21 U.S.C.
Section 510, registrations issued by DEA under 21 U.S.C. Section 823 (if
applicable to any Product), and those issued by State governments for the
conduct of Borrower’s or any Subsidiary’s business.

 

“Permitted Indebtedness” means:

 

(a)     Borrower’s Indebtedness to the Lenders and Agent under this Agreement
and the other Loan Documents;

 

(b)     Indebtedness existing on the Second Restatement Date and described on
Schedule 7.4;

 

(c)     unsecured Indebtedness to trade creditors incurred in the Ordinary
Course of Business;

 

(d)      Indebtedness secured by Permitted Liens;

 

(e)     the Subordinated Debt in an original principal amount not to exceed
Fifteen Million and No/100 Dollars ($15,000,000.00); and

 

(f)     extensions, refinancings, modifications, amendments and restatements of
any items of Permitted Indebtedness (a) through (d) above, provided, however,
that the principal amount thereof is not increased or the terms thereof are not
modified to impose more burdensome terms upon Borrower or its Subsidiary, as the
case may be.

 

 

 
49

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“Permitted Investments” means:

 

(a)     Investments existing on the Second Restatement Date and described on
Schedule 7.7;

 

(b)     Investments consisting of Cash Equivalents; and

 

(c)     Investments in Domestic Subsidiaries that exist as of the Second
Restatement Date or that are formed and have satisfied the Joinder Requirements
in accordance with Section 6.10.

 

“Permitted IP Dispositions” has the meaning given it in Section 7.1.

 

“Permitted Liens” means:

 

(a)     Liens existing on the Second Restatement Date and shown on the
Perfection Certificate or arising under this Agreement and the other Loan
Documents;

 

(b)     Liens for taxes, fees, assessments or other government charges or
levies, either not delinquent or being contested in good faith and for which
Borrower maintains adequate reserves on its Books, provided, however, that no
notice of any such Lien has been filed or recorded under the Internal Revenue
Code of 1986, as amended , and the Treasury Regulations adopted thereunder;

 

(c)     purchase money Liens (i) on Equipment acquired or held by Borrower
incurred for financing the acquisition of the Equipment securing no more than
Two Hundred Fifty Thousand Dollars ($250,000) in the aggregate amount
outstanding, or (ii) existing on Equipment when acquired, if the Lien is
confined to the property and improvements and the proceeds of the Equipment;

 

(d)     statutory Liens securing claims or demands of materialmen, mechanics,
carriers, warehousemen, landlords and other Persons imposed without action of
such parties, provided, however, that they have no priority over any of Agent’s
Lien and the aggregate amount of such Liens does not any time exceed [*]8Dollars
($[*]);

 

(e)     leases or subleases of real property granted in the Ordinary Course of
Business, and leases, subleases, non-exclusive licenses or sublicenses of
property (other than real property or Intellectual Property) granted in the
Ordinary Course of Business, if the leases, subleases, licenses and sublicenses
do not prohibit granting Agent a security interest;

 

(f)     banker’s liens, rights of setoff and Liens in favor of financial
institutions incurred made in the Ordinary Course of Business arising in
connection with Borrower’s deposit accounts or securities accounts held at such
institutions to secure payment of fees and similar costs and expenses subject to
Borrower’s compliance with Section 6.6(b) hereof;

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 
50

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(g)     Liens to secure payment of workers’ compensation, employment insurance,
old-age pensions, social security and other like obligations incurred in the
Ordinary Course of Business (other than Liens imposed by ERISA);

 

(h)     Liens arising from judgments, decrees or attachments in circumstances
not constituting an Event of Default under Section 8.5 or 8.7;

 

(i)      easements, reservations, rights-of-way, restrictions, minor defects or
irregularities in title and similar charges or encumbrances affecting real
property not constituting a Material Adverse Change;

 

(j)     non-exclusive licenses of Intellectual Property granted to third parties
in the Ordinary Course of Business and/or Permitted IP Dispositions;

 

(k)     Liens incurred in the extension, renewal or refinancing of the
indebtedness secured by Liens described in (a) and (c) above, but any extension,
renewal or replacement Lien must be limited to the property encumbered by the
existing Lien and the principal amount of the Indebtedness may not increase; and

 

(l)     Liens in the Collateral in favor of the Subordinated Lender pursuant to
the Subordinated Debt Documents and permitted pursuant to the Subordination
Agreement.

 

“Person” means any individual, sole proprietorship, partnership, limited
liability company, joint venture, company, trust, unincorporated organization,
association, corporation, institution, public benefit corporation, firm, joint
stock company, estate, entity or government agency.

 

“PPD” means PPD Development, LP, a Texas limited partnership.

 

“Prepayment Fee” means with respect to the Term Loan subject to prepayment prior
to the Maturity Date, whether by mandatory or voluntary prepayment, acceleration
or otherwise, an additional fee payable to the Lenders in amount equal to:

 

(a)      for a prepayment made on or after the Second Restatement Date through
and including the date which is twelve (12) months after the Second Restatement
Date, three and one half of one percent (3.5%) multiplied by the original Term
Loan Commitments;

 

(b)     for a prepayment made after the date which is twelve (12) months after
the Second Restatement Date through and including the date which is twenty-four
(24) months after the Second Restatement Date, three percent (3.0%) multiplied
by the original Term Loan Commitments; and

 

(c)     for a prepayment made after the date which is twenty-four (24) months
after the Second Restatement Date through and including the date which is
thirty-six (36) months after the Second Restatement Date, two percent (2.0%)
multiplied by the original Term Loan Commitments.

 

 

 
51

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“Pro Rata Share” means, as determined by Agent, with respect to each Lender, a
percentage (expressed as a decimal, rounded to the ninth decimal place)
determined by dividing the amount of the Term Loan held by such Lender by the
aggregate amount of the outstanding Term Loan.

 

“Products” means the Development Compounds and/or Sale Compounds.

 

“Registered Organization” means any “registered organization” as defined in the
Code, with such additions to such term as may hereafter be made.

 

“Required Lenders” means Lenders having (a) more than 60% of the Term Loan
Commitments of all Lenders, or (b) if such Term Loan Commitments have expired or
been terminated, more than 60% of the aggregate outstanding principal amount of
the Term Loan; provided, however, that so long as a party that is a Lender
hereunder on the Restatement Date does not assign any portion of its Term Loan
Commitment or its portion of the Term Loan, the term “Required Lenders” shall
include such Lender. For purposes of this definition only, a Lender shall be
deemed to include itself, and any Lender that is an Affiliate or Approved Fund
of such Lender.

 

“Required Permit” means a Permit (a) issued or required under Laws applicable to
the business of Borrower or any of its Subsidiaries or necessary in the
manufacturing, importing, exporting, possession, ownership, warehousing,
marketing, promoting, sale, labeling, furnishing, distribution or delivery of
goods or services under Laws applicable to the business of Borrower or any of
its Subsidiaries or any Drug Application (including without limitation, at any
point in time, all licenses, approvals and permits issued by the FDA or any
other applicable Governmental Authority necessary for the testing of any
Development Compound or the manufacture, marketing or sale of any Sale Compound
by any applicable Borrower(s) as such activities are being conducted by such
Borrower with respect to such Product at such time), and (b) issued by any
Person from which Borrower or any of their Subsidiaries have received an
accreditation.

 

“Requirement of Law” means as to any Person, the organizational or governing
documents of such Person, and any Law (statutory or common), treaty, rule or
regulation or determination of an arbitrator or a court or other Governmental
Authority, in each case applicable to or binding upon such Person or any of its
property or to which such Person or any of its property is subject.

 

“Reserve Percentage” means, on any day, for any Lender, the maximum percentage
prescribed by the Board of Governors of the Federal Reserve System (or any
successor Governmental Authority) for determining the reserve requirements
(including any basic, supplemental, marginal, or emergency reserves) that are in
effect on such date with respect to eurocurrency funding (currently referred to
as “eurocurrency liabilities”) of that Lender, but so long as such Lender is not
required or directed under applicable regulations to maintain such reserves, the
Reserve Percentage shall be zero.

 

“Responsible Officer” means any of the Chairman, President, Chief Medical
Officer or Chief Financial Officer of Borrower.

 

 

 
52

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“Restatement Agent” has the meaning given to it in the preamble to this
Agreement.

 

“Restatement Date” has the meaning given to it in the preamble to this
Agreement.

 

“Restatement Lenders” has the meaning given to it in the preamble to this
Agreement.

 

“Restatement Loan Agreement” has the meaning given to it in the preamble to this
Agreement.

 

“Sale Compound” means any therapeutic compound approved for marketing (“Approved
Drug”) that is manufactured, marketed or sold by any Borrower or any of its
Subsidiaries, it being acknowledged and understood that as of the Second
Restatement Date, neither Borrower nor any of its Subsidiaries manufactures and
sells Approved Drugs; provided, in the event Borrower or its Subsidiaries
engages in the manufacture or sale of Approved Drugs subsequent to the Second
Restatement Date and Borrower fails to comply with the obligations under Section
6.2(d) to give notice to Agent and update Schedule 5.11 prior to manufacturing
or selling any new Approved Drug, any such improperly undisclosed Approved Drug
shall be deemed to be included in this definition.

 

“Sale Inventory” means the inventory of Sale Compounds manufactured and held for
sale by any Borrower or any of its Subsidiaries, including without limitation
such inventory of Sale Compounds as is temporarily out of Borrower’s custody or
possession or in transit and including any returned Sale Compounds inventory.

 

“Second Global Reaffirmation Agreement” means that certain Second Omnibus
Amendment and Reaffirmation Agreement, dated as of the Second Restatement Date,
among Borrower and Agent, as the same may be amended, restated, replaced,
supplemented or otherwise modified from time to time.

 

“Second Restatement Date” has the meaning given to it in the preamble to this
Agreement.

 

“Secretary’s Certificate” means, with respect to any Person, a certificate, in
form and substance satisfactory to Agent, executed by such Person’s secretary on
behalf of such Person certifying that (a) such Person has the authority to
execute, deliver, and perform its obligations under each of the Loan Documents
to which it is a party, (b) that attached as Exhibit A to such certificate is a
true, correct, and complete copy of the Borrower Resolutions then in full force
and effect authorizing and ratifying the execution, delivery, and performance by
such Person of the Loan Documents to which it is a party, (c) the name(s) of the
Person(s) authorized to execute the Loan Documents on behalf of such Person,
together with a sample of the true signature(s) of such Person(s), and (d) that
Agent and the Lenders may conclusively rely on such certificate unless and until
such Person shall have delivered to Agent a further certificate canceling or
amending such prior certificate.

 

“Secured Promissory Note” has the meaning given it in Section 2.7.

 

“Secured Promissory Note Record” means a record maintained by each Lender with
respect to the outstanding Obligations and credits made thereto.

 

 

 
53

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“Securities Account” means any “securities account”, as defined in the Code,
with such additions to such term as may hereafter be made.

 

“Subject Intellectual Property” has the meaning given it in Section 5.2(d).

 

“Subordination Agreement” means that certain Subordination Agreement, dated as
of the Second Restatement Date, by and among Borrower, Agent and Subordinated
Lender, which Subordination Agreement shall be in form and substance
satisfactory to Agent, as the same may be amended, restated, supplemented or
otherwise modified from time to time.

 

“Subordinated Debt” means the indebtedness incurred by Borrower which is (i)
owed to Subordinated Lender pursuant to the Subordinated Debt Documents and (ii)
subordinated to all of Borrower’s now or hereafter indebtedness to the Agent and
Lenders (pursuant to the Subordination Agreement).

 

“Subordinated Debt Documents” means (a) the Loan and Security Agreement dated
even date herewith by and among the Borrower and Subordinated Lender, (b) the
Secured Promissory Note dated even date herewith in the principal amount of
$15,000,000 issued by Borrower in favor of Subordinated Lender and (c) the
Pledge Agreement dated even date herewith executed by Borrower in favor of
Subordinated Lender and any other agreements, instruments or other documents
executed or delivered in connection therewith, in each case in form and
substance satisfactory to Agent.

 

“Subordinated Lender” means the Fredric Neville Eshelman Revocable Trust u/a
dated July 13, 1988, as amended and/or restated, together with any successors or
assigns to the extent permitted by the Subordination Agreement.

 

“Subsidiary” means, with respect to any Person, any Person of which more than
50.0% of the voting stock or other equity interests (in the case of Persons
other than corporations) is owned or controlled, directly or indirectly, by such
Person or one or more of Affiliates of such Person.

 

“Takeda” means, either individually or collectively as the context may require,
Takeda San Diego, Inc., a Delaware corporation and Takeda Pharmaceutical Company
Limited, a company organized and existing under the laws of Japan.

 

“Term Loan” has the meaning given it in Section 2.2(a).

 

“Term Loan Commitment” means, for any Lender, the obligation of such Lender to
fund a portion of the Term Loan, up to the principal amount shown on Schedule 1.
“Term Loan Commitments” means the aggregate amount of such commitments of all
Lenders.

 

“Transfer” has the meaning given it in Section 7.1.

 

[SIGNATURES APPEAR ON FOLLOWING PAGE(S)]     

 

 

 
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
as of the Second Restatement Date.

 

 

BORROWER:

 

FURIEX PHARMACEUTICALS, INC.

 

By: /s/ Marshall Woodworth                    (SEAL)

Name: Marshall Woodworth
Title: Chief Financial Officer

 

 

APBI HOLDINGS, LLC

 

By: /s/ Marshall Woodworth                    (SEAL)

Name: Marshall Woodworth
Title: Chief Financial Officer

 

 

DEVELOPMENT PARTNERS, LLC

 

By: /s/ Marshall Woodworth                    (SEAL)

Name: Marshall Woodworth
Title: Chief Financial Officer

 

 

GENUPRO, INC.

 

By: /s/ Marshall Woodworth                    (SEAL)

Name: Marshall Woodworth
Title: Chief Financial Officer

 

 

AGENT:

 

MIDCAP FUNDING III, LLC,

as Agent for Lenders

 

 

By:/s/ Josh Groman                          (SEAL)
Name: Josh Groman                         
Title: Managing Director        

 

[SIGNATURE PAGE TO SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT]

 

 

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LENDERS:

 

MIDCAP FUNDING III, LLC,

as a Lender

 

By:/s/ Josh Groman                          (SEAL)
Name: Josh Groman                         
Title: Managing Director

 

 

 

Address for notices:

 

MidCap Funding III, LLC

7255 Woodmont Avenue, Suite 200

Bethesda, Maryland 20814

Attention: Portfolio Management- Life Sciences

Fax: (301) 941-1450

E-Mail: Lviera@midcapfinancial.com

 

with a copy to:     

 

Midcap Financial, LLC

7255 Woodmont Avenue, Suite 200

Bethesda, Maryland 20814

Attention: General Counsel

Fax: (301) 941-1450

E-Mail: Rgoodridge@midcapfinancial.com

 

[SIGNATURE PAGE TO SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT]

 

 

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MIDCAP FUNDING V, LLC,

as a Lender

 

By:/s/ Josh Groman                          (SEAL)
Name: Josh Groman                         
Title: Managing Director

 

Address for notices:

 

MidCap Funding V, LLC

7255 Woodmont Avenue, Suite 200

Bethesda, Maryland 20814

Attention: Portfolio Management- Life Sciences

Fax: (301) 941-1450

E-Mail: Lviera@midcapfinancial.com

 

with a copy to:     

 

Midcap Financial, LLC

7255 Woodmont Avenue, Suite 200

Bethesda, Maryland 20814

Attention: General Counsel

Fax: (301) 941-1450

E-Mail: Rgoodridge@midcapfinancial.com

 

[SIGNATURE PAGE TO SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT]

 

 

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SILICON VALLEY BANK,

as a Lender

 

By: /s/ Chris Stoecker (SEAL)
Name: Chris Stoecker
Title: Director

 

Address for notices:

 

Silicon Valley Bank

3005 Carrington Mill Boulevard, Suite 530

Morrisville, North Carolina 27560

Attention: Chris Stoecker, Relationship Manager

Fax: (919) 461-3908

 

[SIGNATURE PAGE TO SECOND AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT]

 

 

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EXHIBITS AND SCHEDULES

 

EXHIBITS 

 

Exhibit A

Collateral

Exhibit C

Compliance Certificate

 

 

SCHEDULES

 

Schedule 1

Lenders and Commitments

Schedule 2.2(b)

Amortization Payments

Schedule 5.1

Organizational Information

Schedule 5.2

Collateral Disclosures

Schedule 5.3

Litigation

Schedule 5.11

Products and Required Permits

Schedule 6.14

Post Closing Obligations

Schedule 7.4

Indebtedness

Schedule 7.7

Investments

 

 

 

 

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EXHIBIT A

 

COLLATERAL

 

 

The Collateral consists of all assets of Borrower, including all of Borrower’s
right, title and interest in and to the following personal property:

 

(a)     all goods, Accounts (including health-care insurance receivables),
Equipment, Inventory, contract rights or rights to payment of money, leases,
license agreements, franchise agreements, General Intangibles, commercial tort
claims, documents, instruments (including any promissory notes), chattel paper
(whether tangible or electronic), cash, deposit accounts, investment accounts,
commodity accounts and other Collateral Accounts, all certificates of deposit,
fixtures, letters of credit rights (whether or not the letter of credit is
evidenced by a writing), securities, and all other investment property,
supporting obligations, and financial assets, whether now owned or hereafter
acquired, wherever located; and

 

(b)     all Borrower’s Books relating to the foregoing, and any and all claims,
rights and interests in any of the above and all substitutions for, additions,
attachments, accessories, accessions and improvements to and replacements,
products, proceeds and insurance proceeds of any or all of the foregoing.

 

Notwithstanding the foregoing, the Collateral shall not include any Intellectual
Property of any Loan Party, whether now owned or hereafter acquired, except to
the extent that it is necessary under applicable law to have a Lien and security
interest in any such Intellectual Property in order to have a perfected Lien and
security interest in and to IP Proceeds (defined below), and for the avoidance
of any doubt, the Collateral shall include, and Agent shall have a Lien and
security interest in, (i) all IP Proceeds, and (ii) all payments with respect to
IP Proceeds that are received after the commencement of a bankruptcy or
insolvency proceeding.  The term “IP Proceeds” means, collectively, all cash,
Accounts, license and royalty fees, claims, products, awards, judgments,
insurance claims, and other revenues, proceeds or income, arising out of,
derived from or relating to any Intellectual Property of any Loan Party, and any
claims for damage by way of any past, present or future infringement of any
Intellectual Property of any Loan Party (including, without limitation), all
cash, royalty fees, other proceeds, Accounts and General Intangibles that
consist of rights of payment to or on behalf of a Loan Party and the proceeds
from the sale, licensing or other disposition of all or any part of, or rights
in, any Intellectual Property by or on behalf of a Loan Party).

 

Agent and Lenders further acknowledge that the Collateral shall not include more
than 65% of the voting securities of any Subsidiary that is not organized under
the laws of the United States or any of its states if such pledge would cause a
material increase in the Borrower’s federal income tax liability.

 

Pursuant to the terms of a certain negative pledge arrangement with Agent and
Lenders, Borrower has agreed not to encumber any of its Intellectual Property
without Agent’s and Lenders’ prior written consent.

 

 

 

 

 

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EXHIBIT C

 

 

COMPLIANCE CERTIFICATE

 

 

TO:            MidCap Funding III, LLC, as Agent     

FROM:     __________________________________

DATE:      ________________, 201__

 

The undersigned authorized officer of __________________________________________
(“Borrower”) certifies that under the terms and conditions of the Second Amended
and Restated Loan and Security Agreement, dated September [__], 2013, between
Borrower, Agent and the Lenders party thereto (as amended, restated,
supplemented or otherwise modified from time to time, the “Agreement”):

 

(1)      Borrower is in complete compliance with all required covenants for the
month ending _______________, 201__, except as noted below;

 

(2)      there are no Events of Default;

 

(3)      all representations and warranties in the Agreement are true and
correct in all material respects on this date except as noted below; provided,
however, that such materiality qualifier shall not be applicable to any
representations and warranties that already are qualified or modified by
materiality in the text thereof; and provided, further, that those
representations and warranties expressly referring to a specific date shall be
true, accurate and complete in all material respects as of such date;

 

(4)      Borrower, and each of its Subsidiaries, has timely filed all required
tax returns and reports, and Borrower has timely paid all foreign, federal,
state and local taxes, assessments, deposits and contributions owed by Borrower
except as otherwise permitted pursuant to the terms of Section 5.8 of the
Agreement; and

 

(5)      no Liens have been levied or claims made against Borrower or any of its
Subsidiaries relating to unpaid employee payroll or benefits of which Borrower
has not previously provided written notification to Agent.

 

Attached are the required documents supporting the certifications set forth in
this Compliance Certificate. The undersigned certifies, in his/her capacity as
an officer of the Borrower, that these are prepared in accordance with GAAP
consistently applied from one period to the next except as explained in an
accompanying letter or footnotes. The undersigned acknowledges, in his/her
capacity as an officer of Borrower, that no borrowings may be requested at any
time or date of determination that Borrower is not in compliance with any of the
terms of the Agreement, and that compliance is determined not just at the date
this certificate is delivered. Capitalized terms used but not otherwise defined
herein shall have the meanings given them in the Agreement.

 

 

 

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

 

 

 

Please indicate compliance status by circling Yes/No under “Complies” column.

 

Reporting Covenant

Required

Complies

Monthly Financial Statements

 

Monthly within 45 days

Yes         No

Audited Financial Statements

 

Annually within 150 days after FYE

Yes         No

Board Approved Projections

 

Annually within 90 days after FYE

Yes         No

Compliance Certificate

 

Monthly within 45 days

Yes          No

 

 

 

 

The following are the exceptions with respect to the certification above: (If no
exceptions exist, state “No exceptions to note.”)

 

 

 

 

 

 

 

 

 

 

 

[NAME OF BORROWER]

 

 

By:  __________________________________

Name: ________________________________

Title: _________________________________

AGENT USE ONLY

 

Received by: _______________________________

authorized signer

Date: _____________________________________

 

Verified: ___________________________________

authorized signer

Date: _____________________________________

 

Compliance Status:   Yes           No

 

 

 

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

 

 

 

SCHEDULE 1

 

LENDERS AND COMMITMENTS

 

Lender

Term Loan Commitment

Commitment Percentage

MidCap Funding III, LLC

$10,000,000

24%

MidCap Funding V, LLC

$23,600,000

56%

Silicon Valley Bank

$8,400,000

20%

TOTAL

$42,000,000

100%

 

 

 

 

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

 

 

 

SCHEDULE 2.2(b)

 

AMORTIZATION PAYMENTS

 

Amortization Payment Date

Amortization Payment

May 15, 2014

(for the fiscal quarter ended

March 30, 2014)

$1,680,000.00

August 15, 2014

(for the fiscal quarter ended

June 30, 2014)

$1,680,000.00

September 15, 2014

(for the fiscal quarter ended

If the Eluxadoline Submission Event has occurred prior to the Amortization
Payment Date, the Amortization Payment shall be equal to twenty-five percent
(25.0%) of the Nesina Royalty Payment for the fiscal quarter ended June 30,
2014; provided that such Amortization Payment shall not be greater than
$2,520,000.00.

  June 30, 2014)

If the Eluxadoline Submission Event has not occurred prior to the Amortization
Payment Date, the Amortization Payment shall be equal to twenty-five percent
(25.0%) of the Nesina Royalty Payment for the fiscal quarter ended June 30,
2014; provided that such Amortization Payment shall not be less than
$1,260,000.00 and shall not be greater than $2,520,000.00.

November 15, 2014

(for the fiscal quarter ended

If the Eluxadoline Submission Event has occurred prior to the Amortization
Payment Date, the Amortization Payment shall be equal to fifty percent (50.0%)
of the Nesina Royalty Payment for the fiscal quarter ended September 30, 2014;
provided that such Amortization Payment shall not be less than $1,680,000.00 and
shall not be greater than $4,200,000.00.

September 30, 2014)

If the Eluxadoline Submission Event has not occurred prior to the Amortization
Payment Date, the Amortization Payment shall be equal to fifty percent (50.0%)
of the Nesina Royalty Payment for the fiscal quarter ended September 30, 2014;
provided that such Amortization Payment shall not be less than $2,940,000.00 and
shall not be greater than $4,200,000.00.

 

 

 

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

 

 

 

February 15, 2015,

and the fifteenth day of the second calendar month

If the Eluxadoline Submission Event has occurred prior to the Amortization
Payment Date, the Amortization Payment shall be equal to fifty percent (50.0%)
of the Nesina Royalty Payment for the most recently ended fiscal quarter;
provided that such Amortization Payment shall not be less than $1,680,000.00 and
shall not be greater than $4,200,000.00.

   following each fiscal quarter thereafter, until the Maturity Date

If the Eluxadoline Submission Event has not occurred prior to the Amortization
Payment Date, the Amortization Payment shall be equal to fifty percent (50.0%)
of the Nesina Royalty Payment for the most recently ended fiscal quarter;
provided that such Amortization Payment shall not be less than $2,940,000.00 and
shall not be greater than $4,200,000.00.

Maturity Date

All remaining unpaid principal.

 

 

 

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

 

 

 

SCHEDULE 5.1

 

ORGANIZATIONAL INFORMATION

 

Legal Name of Borrower

Type of Legal Entity

State of Organization

Organizational Identification Number

Tax Identification Number

Principal Place of Business

Furiex Pharmaceuticals, Inc

Corporation

Delaware

4744208

27-1197863

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

APBI Holdings, LLC

Limited Liability Company

North Carolina

0703248

N/A

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

Development Partners, LLC

Limited Liability Company

Delaware

3728473

20-0417496

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

GenuPro, Inc

Corporation

North Carolina

0459382

56-2085866

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

 

 

 

 

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

 

 

 

SCHEDULE 5.2(a)

 

COLLATERAL ACCOUNTS

 

Furiex Pharmaceuticals, Inc. maintains the following Deposit Accounts and
Securities Accounts:

 

Bank Name

Account Number

Branch Address

Merrill Lynch/Funds For Institutions

[*]9

Raleigh, NC

Merrill Lynch

[*]

Raleigh, NC

Silicon Valley Bank

[*]

Santa Clara, CA

Silicon Valley Bank

[*]

Santa Clara CA

Silicon Valley Bank

[*]

Santa Clara CA

Silicon Valley Bank

[*]

Santa Clara CA

Silicon Valley Bank

[*]

Santa Clara CA

SVB Securities

[*]

Santa Clara CA

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

 

 

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

 

 

 

SCHEDULE 5.2(d)

 

INTELLECTUAL PROPERTY

 

 

[APPLIES TO ALL Intellectual Property and License Agreements]

 

Borrower

Name / Identifier of IP or License

Type of IP (e.g.,

patent, TM, ©, mask

work) or License

Agreement

Expiration Date

(if a License, expiration of

License and Licensed Property)

Furiex Pharmaceuticals, Inc.

Furiex website

Copyright

None

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 813,150 (Canada)

Trademark

Renewal due 4/6/2020

Furiex Pharmaceuticals, Inc.

FURIEX App. No. 1039106 (China)

Trademark

Renewal due 5/12/2013

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 009006024 (CTM)

Trademark

Renewal due 4/6/2020

Furiex Pharmaceuticals, Inc.

FURIEX and Design App. No. 009006164 (CTM)

Trademark

Renewal due 4/6/2020

Furiex Pharmaceuticals, Inc.

FURIEX Reg No. 301609083 (HK)

Trademark

Renewal due 5/9/2020

Furiex Pharmaceuticals, Inc.

FURIEX App. No. 2001938 (India)

Trademark

N/A

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 1039106 (Japan)

Trademark

Renewal due 4/6/2020

Furiex Pharmaceuticals, Inc.

FURIEX App. No. 1088170 (Mexico)

Trademark

N/A

Furiex Pharmaceuticals, Inc.

FURIEX App. No. 1039106 (Norway)

Trademark

N/A

Furiex Pharmaceuticals, Inc.

FURIEX App. No. 1039106 (Russian Fed)

Trademark

Renewal due 5/12/2013

 

 

 

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

 

 

 

[APPLIES TO ALL Intellectual Property and License Agreements]

 

Borrower

Name / Identifier of IP or License

Type of IP (e.g.,

patent, TM, ©, mask

work) or License

Agreement

Expiration Date

(if a License, expiration of

License and Licensed Property)

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 1039106 (Switzerland)

Trademark

Renewal due 5/12/2020

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 01450576 (Taiwan)

Trademark

Renewal due 11/23/2020

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 3,881,579 (US)

Trademark

Renewal due 11/23/2020

Furiex Pharmaceuticals, Inc.

FURIEX and Design Reg. No. 3,881,578 (US)

Trademark

Renewal due 11/23/2020

Furiex Pharmaceuticals, Inc.

FURIEX Reg. No. 1039106 (WIPO)

Trademark

Renewal due 5/12/2020

Genupro, Inc.

Reg No. 4949950 (Japan)

PRILIGY in Japanese Characters 1

Renewal due 5/12/2016

Genupro, Inc.

Reg No. 4858569 (Japan)

PRILIGY

Renewal due 4/22/2015

Genupro, Inc.

Reg No. 4910950 (Japan)

PRILIGY in Japanese Characters 2

Renewal due 12/2/2015

Genupro, Inc.

Reg No. 4958979 (Japan)

PRILIGY LOGO

Renewal due 6/9/2016

Furiex Pharmaceuticals, Inc.

Reg No. 4067692 (US)

PRILIGY

Renewal due 12/6/2021

 

 

 

 

 

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

 

 

 

 

[APPLIES TO ALL Intellectual Property and License Agreements]

 

Borrower

Name / Identifier of IP or License

Type of IP (e.g.,

patent, TM, ©, mask

work) or License

Agreement

Expiration Date

(if a License, expiration of

License and Licensed Property)

Furiex Pharmaceuticals, Inc.

MuDelta Development and License Agreement with Janssen Pharmaceutica, N.V.

License Agreement

Expires on a Product-by-Product

and country-by-country basis

until the date no further payment

obligations of Payor to Payee

relating to a Product are due. At

such time, all licenses granted to

the Party Commercializing such

Products under the Agreement in

such country shall survive, but

shall be non-exclusive, fully paid-

up, and royalty-free.

Furiex Pharmaceuticals, Inc.

TOPO Development and License Agreement with Janssen Pharmaceutica, N.V.

License Agreement

Expires on a Product-by-Product

and country-by-country basis

until the date no further payment

obligations of Payor to Payee

relating to a Product are due. At

such time, all licenses granted to

the Party Commercializing such

Products under the Agreement in

such country shall survive, but

shall be non-exclusive, fully paid-

up, and royalty-free.

Furiex Pharmaceuticals, Inc.

License Agreement to Use EQ-5D-3L with Stichting EUROQOL Group

License Agreement

March 15, 2013

 

 

 

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

 

 

[APPLIES TO ALL Intellectual Property and License Agreements]

 

Borrower

Name / Identifier of IP or License

Type of IP (e.g.,

patent, TM, ©, mask

work) or License

Agreement

Expiration Date

(if a License, expiration of

License and Licensed Property)

Genupro, Inc.

License Agreement to Use Priligy Know-How of Alza Corp. and Janssen
Pharmaceutica NV

License and Asset Transfer Agreement

Perpetual license with no obligation to pay royalties or milestones. Exclusive
license to make, use and sell Priligy and other dapoxetine-containing products.
Non-exclusive license to make, use and sell dapoxetine-derivative products.

 

 

 

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

 

 

 

 

Name and Address of

 Licensor

Name and Date of License Agreement

Exclusive License?

(Yes/No)

Restrictions to grant a lien, assign or

sublicense?

(Yes/No)

Janssen Pharmaceutica, N.V.

Turnhoutseweg 30

2340 Beerse

Belgium

MuDelta Development and License Agreement

November 16, 2009

Yes

Yes

Janssen Pharmaceutica, N.V.

Turnhoutseweg 30

2340 Beerse

Belgium

TOPO Development and License Agreement

November 16, 2009

Yes

Yes

Alza Corp.

700 Eubanks Drive

Vacaville, CA 95688; and Janssen Pharmaceutica NV

Turnhoutseweg 30

2340 Beerse

Belgium

License and Asset Transfer Agreement

July 30, 2012

Yes (to use licensed IP for certain uses)

Yes

GenuPro, Inc.

3900 Paramount Parkway

Suite 150

Morrisville, NC 27560

Berlin Chemie (Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Priligy License Agreement

July 30, 2012

Yes

Yes

Xiamen Fuman Pharmaceuticals Co., Ltd

No. 55 Jintingbei Road

Jimei District

Xiamen

Patent License Contract

February 23, 2012

No

Yes

GenuPro, Inc.

3900 Paramount Parkway

Suite 150

Morrisville, NC 27560; and

Eli Lilly & Company

Lilly Corporate Center

Indianapolis, Indiana 46285

Termination and License Agreement

December 18, 2003

Yes

Yes

 

 

 

 

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

 

 

 

 

Name and Address of

 Licensor

Name and Date of License Agreement

Exclusive License?

(Yes/No)

Restrictions to grant a lien, assign or

sublicense?

(Yes/No)

Stichting EUROQOL Group

3311 CR Dordrecht

Netherlands

License Agreement to Use EQ-5D-3L

March 15, 2010

No

Yes

Mapi Research Trust

License Agreement to Use IBS-QOL Questionnaire

No

Yes

MultiHealth Systems, Inc.

License Agreement to Use POMS Questionnaire

No

Yes

David Sheehan

License Agreement to Use Sheehan Disability Scale

No

Yes

 

 

 

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

 

 

 

EXHIBIT 5.2(d)

 

PATENTS

 

[Updated September 13, 2013]

 

 

CO

Patent Number

Serial No.

Issue Date Title Estimated Expiration Date

Patents Owned by APBI Holdings, LLC

 

Chile

 

1333/2004

5/31/2004

 

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

N/A

Japan

3,194,734

259000/2000

8/29/00

6/1/01

Methods of Using Rapid-Onset Serotonin Reuptake Inhibitors for Treating Sexual
Dysfunction

[*]

Malaysia

125490-A

PI 20003983

8/29/00

8/30/06

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Australia

762934

68911/00

8/22/00

10/30/03

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Bulgaria

BG65677

106.461

8/22/00

8/26/2009

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Brazil

 

PI0014166-6

8/22/00

 

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction10

N/A

Brazil

 

PI0017554-4

8/22/00

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction11

N/A

Canada

2,383,785

2,383,785

8/22/00

2/17/09

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

China

ZL 00815313.2

(announcement no. CN 1222283)

00815313.2

8/22/00

10/12/2005

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Costa

Rica

 

6602

8/22/00

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

N/A

 

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO

Patent Number

Serial No.

Issue Date Title Estimated Expiration Date

Czech

Rep

299 712

PV2002-784

8/22/00

9/18/08

Use of Dapoxetine for Management of Sexual Dysfunction by Administering on an
As-Needed Basis12

[*]

Armenia

Azerbaijan

Belarus

Kazakhstan

Kyrgyzstan

Moldova

Russia

Tajikistan

Turkmenistan

004101

200200324

8/22/00

12/25/03

Use of a Rapid-Onset Serotonin Reuptake Inhibitors for Treating Sexual
Dysfunction

[*]

Estonia

05315

P200200107

8/22/00

9/7/10

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

EPO

Albania

Austria

Belgium

Switzerland

Cyprus

Germany

Denmark

Spain

Finland

France

Greece

Ireland

Italy

Lithuania

Luxembourg

Latvia

Monaco

Macedonia

Netherlands

Portugal

Romania

Sweden

Slovenia

UK

1225881

 

German Patent No. 60026146.8-08

00957264.5

8/22/00

2/22/06

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

 

[*]

Austria

Germany

Spain

Finland

Italy

Netherlands

Portugal

Sweden

 

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Austria

1225881

SZ 22/2009

7/10/09

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Denmark

1225881

CA 2012 00020

May 15, 2012

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Estonia

1225881

00063

August 31, 2012

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Finland

1225881

C20090019 7/10/09

SPC Cert No. 252

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

France

1225881

12C0052

August 29, 2012

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Germany

1225881

12 2009 000 036.2

7/14/09

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Italy

1225881

9/22/09

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Latvia

1225881

P2570/SPC

October 9 2012

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Luxembourg

1225881

92204

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Netherlands

1225881

300533

July 14, 2012

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction13

[*]

Portugal

1225881

20091000062783

6/30/09

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Slovenia

1225881

C201240022

October 15, 2012

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Spain

1225881

C200900036

9/18/09

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Sweden

1225881

587735

7/6/09

 

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

EPO divisional

1671628

German Patent No. 60047584.4

06002333.0

8/22/00

10/2/12

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Hong Kong

HK1047545

02109124.8

8/22/00

9/22/06

The Use of Dapoxetine, A Rapid-Onset Selective Serotonin Reuptake Inhibitor, For
Treating Sexual Dysfunction

[*]

Hong Kong

HK1091418

06113173.6

8/22/00

3/8/13

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Hong Kong

 

08105295.3

8/22/00

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Philippines

1-2000-002326

1-2000-002326

10/17/01

8/6/07

The Use of Dapoxetine, a Rapid-Onset Selective Serotonin Reuptake Inhibitor, for
Treating Sexual Dysfunction

[*]

Hungary

229 150

P02 02687

8/22/00

8/5/13

Methods of Using Rapid-Onset Serotonin Reuptake Inhibitors for Treating Sexual
Dysfunction

N/A

Indonesia

ID 0 018 894

W-00 2002 00522

8/22/00

2/27/07

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Israel

148159

148159

8/22/00

2/19/10

Use of dapoxetine or a pharmaceutically acceptable salt thereof for the
manufacture of a medicament for the treatment or management of sexual
dysfunction

[*]

S. Korea

719977

10-2002-7002870

8/22/00

5/14/07

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

S. Korea

719977

10-2009-0092209

9/29/09

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Mexico

236520

PA/A/2002/001811

8/22/00

5/4/06

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Norway

330562

20021035

8/22/00

5/16/11

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

New Zealand

517038

517038

8/22/00

8/7/03

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Poland

211402

P-364924

8/22/00

11/24/11

Methods of Using Rapid-Onset Serotonin Reuptake Inhibitors for Treating Sexual
Dysfunction14

[*]

Singapore

87218

200200910-8

8/22/00

5/31/05

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Ukraine

75580

2002031755

8/22/00

5/15/06

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

US

7,718,705

10/049,427

5/6/2002

5/18/10

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

US

 

10/996,757

11/24/04

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

N/A

South Africa

2002/1407

8/22/00

7/30/03

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

[*]

Taiwan

I312678

089117155

8/25/00

8/1/2009

Pharmaceutical Composition Comprising Dapoxetine for Treating Sexual Dysfunction

[*]

Taiwan

I367751

098145182

7/11/12

Pharmaceutical Composition Comprising Rapid-Onset Selective Serotonin Reuptake
Inhibitors for Treating Sexual Dysfunction

[*]

Venezuela

 

2000-001911

8/29/00

 

Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for
Treating Sexual Dysfunction

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date Patents
Owned by Furiex Pharmaceuticals, Inc.

US

7,994,206

12/168,331

07/07/2008

 8/9/2011

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

[*]

Australia

1516

2008275270

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Brazil

 

PI0813632-7

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Canada

 

2695126

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

China

 

20080024059.7

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Colombia

 

10-000935

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Costa Rica

 

N/A

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Eurasia

 

201070116

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Ecuador

 

10-9863

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Egypt

 

33/2010

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

EP

 

08781434.9

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Hong Kong

 

10107932.4

08/19/2010

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

 

 

 [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Indonesia

 

W00201000054

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Israel

 

203081

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

India

 

58/KOLNP/2010

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Japan

 

516175/10

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

South Korea

 

10-2010-7002535

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Mexico

 

MX/A/2010/000323

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Malaysia

 

PI2010000053

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Nicaragua

 

2010/0001

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Norway

 

08781434.9

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

New Zealand

 

582420

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Philippines

 

10-2010-500060

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Singapore

 

201000095-8

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

Singapore

 

201208093.3

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Ukraine

 

201001286

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

United States

7,994,206

12/168,331

07/07/2008

8/9/2011

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

[*]

Vietnam

 

1-2009-02869

07/07/2008

 

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

United States

 

13/175,342

07/07/2008

 

 Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

N/A

South Africa

2010/0921

2010/0921

07/07/2008

4/28/2011

Novel crystals and process of making
5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic
acid

[*]

Patents Licensed to Furiex

Albania

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Albania

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Armenia

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Argentina

 

P040103422

09/22/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Argentina

 

P060101080

03/20/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Austria

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Austria

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Australia

2004278320

09/09/2004

07/Oct/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Australia

 

2006227984

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Azerbaijan

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Bosnia-Herz

17

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Belgium

 

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Belgium

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Bulgaria

 

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Bulgaria

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Brazil

 

PI0414573-9

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Brazil

 

PI0609426-0

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Belarus

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Canada

 

2539349

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Canada

 

2602140

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Switz

 

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Switz

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Chile

43.639

2394/04

09/20/2004

08/11/2008

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

PRC

200480033788.0

200480033788.0

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

PRC

200680017405.X18

200680017405.X

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Colombia

07099564

07099564

02/02/2006

02/28/2013

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Costa Rica

 

9458

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Cyprus

 

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Cyprus

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Czech Rep

 

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Czech Rep

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Germany

602004019555.3

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Germany

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Denmark

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Denmark

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Eurasia

200702039

02/02/2006

12/30/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Ecuador

 

07-7768

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Estonia

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Estonia

19

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

EPO

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

EPO

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Spain

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Spain

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Finland

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Finland

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

France

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

France

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

UK

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

UK

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Greece

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Greece

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Croatia

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Hungary

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Hungary

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Indonesia

 

WO0200600776

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Indonesia

W00200703068

W00200703068

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Ireland

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Ireland

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Israel

 

174397

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Israel

 

186041

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

India

675/KOLNP/06

09/09/2004

10/Sep/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

India

 

4032/KOLNP/07

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Iceland

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Italy

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Italy

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Japan

 

526944/06

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Japan

497768420

502985/08

02/02/2006

18/Jul/2012

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Kirghizistan

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

S Korea

10-2006-7007817

10-2006-7007817

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

S Korea

 

10-2007-7024070

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Kazakhstan

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Sri Lanka

 

PCT/US2006/003657

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Lithuania

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Lithuania

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Luxembourg

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Luxembourg

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Latvia

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Latvia

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Monaco

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Monaco

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Moldova

 20070203921

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Macedonia

04783671.3

P/EP-2009/70

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Macedonia

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Malta

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Mexico

264642

PA/A/2006/003186

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Mexico

 

MX/A/2007/011774

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Malaysia

 

PI20043865

09/21/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Malaysia

 

PI20061247

03/21/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Nicaragua

 

2007/0243

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Netherlands

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Netherlands

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Norway

 

20075385

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

New Zealand

545970

09/09/2004

10/Sep/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

New Zealand

561651

561651

02/02/2006

01/09/12

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Philippines

1-2007-502041

1-2007-502041

02/02/2006

20/Dec/2011

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Poland

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Poland

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Portugal

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Portugal

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Romania

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Romania

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Russia

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Russia

 

2350615

2006109004

09/09/2004

03/27/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Sweden

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Sweden

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Singapore

200708487-4

02/02/2006

31/Aug/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Slovenia

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Slovak Rep

1675852

04783671.3

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Slovak Rep

22

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Tadjikistan

 200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Turkmenistan

200702039

02/Feb/2006

30/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Turkey

1675852

09/09/2004

02/18/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Turkey

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Taiwan

I312678

93128488

09/21/2004

8/1/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Taiwan

 

95109374

03/20/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Ukraine

A200710571

a200710571

02/02/2006

03/10/2011

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

US

 

7179805

10/937238

09/09/2004

02/20/2007

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

US

 

7732612

11/084987

03/21/2005

08/Jun/2010

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

Vietnam

 

1-2007-01885

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

PCT

 

PCT/US2004/029523

09/09/2004

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

PCT

 

PCT/US2006/003657

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

N/A

Serbia/Montenegro

 

06720136.8

02/02/2006

 

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

 

SA

2006/03223

09/09/2004

09/26/2007

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

SA

2007/08868

02/02/2006

01/28/2009

7-aminoakylidenyl-heterocyclic quinolones and napthyridones

[*]

US

7902227

12/180641

07/28/2008

08/Mar/2011

C-7 Isoxazolinyl Quinolone / Naphthyridine Derivatives Useful as Antibacterial
Agents

[*]

Australia

2009233679

2009233679

11/05/2009

9/8/2011

 Compounds as Opioid Receptor Modulators

[*]

Australia

2011202364B

2011202364

5/20/2011

01/03/2013

 Compounds as Opioid Receptor Modulators

[*]

Australia

23

2012268813

12/20/2012

 

Compounds as Opioid Receptor Modulators

N/A

AUSTRIA

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

AUSTRIA

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

BELGIUM

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

BELGIUM

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

BULGARIA

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

BULGARIA

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Brazil

 

PI0309708-0

04/17/2003

 

 Compounds as Opioid Receptor Modulators

N/A

Canada

2483662

2483662

04/17/2003

 

 Compounds as Opioid Receptor Modulators

[*]

Canada

 

2753371

 

 Compounds as Opioid Receptor Modulators

N/A

PRC

ZL03815199.5

200810086599

04/17/2003

 10/6/2012

Compounds as Opioid Receptor Modulators

[*]

PRC

ZL200580014571X

3815200

04/17/2003

 9/26/2012

 Compounds as Opioid Receptor Modulators

[*]

Colombia

4120039

4120039

04/17/2003

 

 Compounds as Opioid Receptor Modulators

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Colombia

04120039A

04120039A

2/13/2009

6/25/2010

Compounds as Opioid Receptor Modulators

[*]

Colombia

04120039B

04120039B

2/13/2009

8/28/2010

 Compounds as Opioid Receptor Modulators

[*]

CYPRUS

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

CYPRUS

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

CZECH REPUBLIC

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

CZECH REPUBLIC

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

GERMANY

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

GERMANY

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

DENMARK

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]24

DENMARK

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

EPO

1499313

3719806

04/17/2003

 07/07/2011

 Compounds as Opioid Receptor Modulators

[*]

EPO

 

10180687.5

4/17/2003

 

Compounds as Opioid Receptor Modulators

N/A

Estonia

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

Estonia

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Hong Kong

 

11107444.4

7/18/2011

 

Compounds as Opioid Receptor Modulators

N/A

HUNGARY

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

HUNGARY

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

FINLAND

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

FINLAND

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

FRANCE

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

FRANCE

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

GREECE

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

GREECE

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Croatia

 

P20041014

04/17/2003

 

Compounds as Opioid Receptor Modulators

N/A

Indonesia

 

W00200703271

04/17/2003

 

 Compounds as Opioid Receptor Modulators

N/A

Indonesia

P0028365

W00200402406

04/17/2003

 05/26/2011

 Compounds as Opioid Receptor Modulators

[*]

IRELAND

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

IRELAND

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Israel

 

197642

04/17/2003

 

 Compounds as Opioid Receptor Modulators

N/A

Israel

164910

164910

04/17/2003

 11/1/2011

Compounds as Opioid Receptor Modulators

[*]

India

 

4156/KOLNP/2012

12/28/2012

 

 Compounds as Opioid Receptor Modulators

N/A

India

 

853/KOLNP/08

04/17/2003

 

 Compounds as Opioid Receptor Modulators

N/A

India

222148

1727/KOLNP/04

04/17/2003

 07/23/2008

 Compounds as Opioid Receptor Modulators

[*]

ITALY

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

ITALY

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Japan

4969039

500872/04

04/17/2003

 04/13/2012

 Compounds as Opioid Receptor Modulators

[*]

S Korea

10-1287409

10-2004-7017395

04/17/2003

 07/12/2013

Compounds as Opioid Receptor Modulators

[*]

S Korea

 

10-2013-7005624

03/05/2013

 

 Compounds as Opioid Receptor Modulators

N/A

           

Mexico

281996

MX/A/2007/013630

04/17/2003

 12/13/2010

 Compounds as Opioid Receptor Modulators25

[*]

Mexico

253361

PA/A/2004/011947

04/17/2003

01/14/2008

 Compounds as Opioid Receptor Modulators

[*]

MONACO

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

MONACO

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Netherlands

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

Netherlands

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Norway

332722

20045159

04/17/2003

 12/27/2012

Compounds as Opioid Receptor Modulators

[*]

Norway

 

20120788

04/17/2003

 

Compounds as Opioid Receptor Modulators

N/A

New Zealand

561795

04/17/2003

08/13/2009

 Compounds as Opioid Receptor Modulators

[*]

New Zealand

575640

575640

04/17/2003

  2/9/2011

 Compounds as Opioid Receptor Modulators

[*]

Philippines

1-2004-501742

04/17/2003

 09/22/2009

 Compounds as Opioid Receptor Modulators

[*]

Poland

211163

374053

04/17/2003

 

Compounds as Opioid Receptor Modulators

[*]

Poland

 

374053

9/22/2009

Compounds as Opioid Receptor Modulators

N/A

PORTUGAL

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

PORTUGAL

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

ROMANIA

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

ROMANIA

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Russia

 

2332411

2004131829

04/17/2003

08/27/2008

 Compounds as Opioid Receptor Modulators

[*]

Singapore

200406282-4

04/17/2003

11/30/2006

 Compounds as Opioid Receptor Modulators

[*]

SLOVENIA

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

SLOVENIA

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

SLOVAC REPUBLIC

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

SLOVAC REPUBLIC

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

SWEDEN

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

SWEDEN

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Switzerland

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators

[*]

Switzerland

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

TURKEY

1499313

3719805.8

6/29/2011

 Compounds as Opioid Receptor Modulators26

[*]

TURKEY

 

10180687.5

 

 Compounds as Opioid Receptor Modulators

N/A

Ukraine

97251

200902108

04/17/2003

 01/25/2012

 Compounds as Opioid Receptor Modulators

[*]

Ukraine

87962

20041109807

04/17/2003

 09/10/2009

Compounds as Opioid Receptor Modulators

[*]

US

 

7,041,681

10/400,006

03/26/2003

 05/09/2006

 Compounds as Opioid Receptor Modulators

[*]

US

 

7,202,381

11/079,573

03/14/2005

 04/10/2007

 Compounds as Opioid Receptor Modulators

[*]

US

7,659,402

11/242,763

10/04/2005

 02/09/2010

 Compounds as Opioid Receptor Modulators

[*]

         

 

SA

2004/9554

04/17/2003

07/26/2006

 Compounds as Opioid Receptor Modulators

[*]

Albania

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Albania

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Albania

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Argentina

 

P050101007

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Austria

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Australia

2005224091

2005224091

03/15/2005

 5/17/2012

 Compounds as Opioid Receptor Modulators

[*]

Australia

 

2012202459

3/15/2005

 Compounds as Opioid Receptor Modulators

N/A

Australia

 

2013205089

4/13/2013

 Compounds as Opioid Receptor Modulators

N/A

Belgium

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Belgium

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Belgium

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Brazil

 

2005224091

03/15/2005

 

Compounds as Opioid Receptor Modulators

N/A

Bulgaria

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Bulgaria

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Bulgaria

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Canada

 

2560047

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Chile

48323

2005-0557

03/15/2005

 06/05/2012

 Compounds as Opioid Receptor Modulators

[*]

PRC

200580014571.X

200580014571.X

03/15/2005

 09/26/2012

 Compounds as Opioid Receptor Modulators

[*]

PRC

 

201210277845.6

 

Compounds as Opioid Receptor Modulators

N/A

Colombia

 

6093425

03/15/2005

 

Compounds as Opioid Receptor Modulators

N/A

Costa Rica

 

8655

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Croatia

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators27

[*]

Croatia

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Croatia

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Cyprus

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

 

 

 [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Cyprus

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Cyprus

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Czech Republic

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Czech Republic

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Czech Republic

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Denmark

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Denmark

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Denmark

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

           

Ecuador

 

SP-06-6856

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Egypt

 

861/2006

03/15/2005

 

Compounds as Opioid Receptor Modulators

N/A

Estonia

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators28

[*]

Estonia

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Estonia

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

EPO

1725537

5728171.9

03/15/2005

 07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

EPO

 

10182349.0

03/15/2005

 

Compounds as Opioid Receptor Modulators

N/A

EPO

 

12194058.9

03/15/2005

 

Compounds as Opioid Receptor Modulators

N/A

Finland

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Finland

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Finland

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

France

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

France

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

France

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Germany

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Germany

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Germany

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Greece

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators29

[*]

Greece

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Greece

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

HK

HK1099016

7105593

03/15/2005

 5/4/2012

 Compounds as Opioid Receptor Modulators

[*]

HK

 

7111210.4

10/17/2007

 

 Compounds as Opioid Receptor Modulators

N/A

HK

 

7111210.4

10/17/2007

 

 Compounds as Opioid Receptor Modulators

N/A

Hungary

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Hungary

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Hungary

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Iceland

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Iceland

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Iceland

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Indonesia

 

W00200602542

03/15/2005

 

Compounds as Opioid Receptor Modulators

N/A

 

 

 [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Ireland

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Ireland

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators30

N/A

Ireland

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Israel

 

178040

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Israel

 

224908

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Italy

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Italy

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Italy

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

India

254073

2981/KOLNP/06

03/15/2005

 

 Compounds as Opioid Receptor Modulators

[*]

Japan

4778954

503986/07

03/15/2005

 07/08/2011

Compounds as Opioid Receptor Modulators

[*]

S Korea

10-1166342

10-2006-7021231

03/15/2005

 07/11/2012

 Compounds as Opioid Receptor Modulators

[*]

           

LATVIA

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

LATVIA

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

LATVIA

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

LITHUANIA

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

LITHUANIA

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

LITHUANIA

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

LUXEMBOURG

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

LUXEMBOURG

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

LUXEMBOURG

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Mexico

280308

PA/A/2006/010642

03/15/2005

 

 Compounds as Opioid Receptor Modulators

[*]

Mexico

301581

MX/A/2010/008741

03/15/2005

07/23/2012

Compounds as Opioid Receptor Modulators

N/A

Mexico

 

MX/A/2012/002495

07/20/2012

 

Compounds as Opioid Receptor Modulators

N/A

Malaysia

MY-146972-A

PI20051060

03/15/2005

 10/15/2012

Compounds as Opioid Receptor Modulators

N/A

Malaysia

 

PI2011002456

 

Compounds as Opioid Receptor Modulators

N/A

MONACO

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

MONACO

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

MONACO

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Montenegro

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Netherlands

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Netherlands

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Netherlands

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

           

Norway

 

20064660

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

New Zealand

549842

549842

03/15/2005

 2/9/2011

Compounds as Opioid Receptor Modulators

N/A

Philippines

 

1-2006-501823

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Philippines

 

1-2012-501640

08/14/2012

 

 Compounds as Opioid Receptor Modulators

N/A

POLAND

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators31

[*]

POLAND

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

POLAND

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

PORTUGAL

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

PORTUGAL

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

PORTUGAL

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

ROMANIA

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

ROMANIA

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators32

N/A

ROMANIA

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Singapore

125535

200606297-0

03/15/2005

03/31/2009

 Compounds as Opioid Receptor Modulators

[*]

SLOVENIA

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

SLOVENIA

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

SLOVENIA

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

SLOVAK REPUBLIC

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

SLOVAK REPUBLIC

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

SLOVAK REPUBLIC

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Spain

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Spain

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Spain

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

SWEDEN

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

SWEDEN

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

SWEDEN

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Switzerland

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

Switzerland

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators33

N/A

Switzerland

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Taiwan

I361069

94107612

03/15/2005

 04/01/2012

 Compounds as Opioid Receptor Modulators

[*]

TURKEY

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

TURKEY

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

TURKEY

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

Ukraine

86053

A200609824

03/25/2009

Compounds as Opioid Receptor Modulators

[*]

UK

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

UK

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

UK

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

US

 

7,741,356

11/079,647

03/14/2005

 6/22/10

 Compounds as Opioid Receptor Modulators

[*]

US

 

7,786,158

11/877,747

10/24/2007

 8/31/10

 Compounds as Opioid Receptor Modulators

[*]

US

8,344,011

12/838,825

1/1/2013

Compounds as Opioid Receptor Modulators

[*]

US

 

13/690,041

 

Compounds as Opioid Receptor Modulators

N/A

VIETNAM

 

1-2006-01521

 

 Compounds as Opioid Receptor Modulators

N/A

YUGOSLAVIA (Serbia/Montenegro)

05728171.9

5728171.9

03/15/2005

07/13/2011

 Compounds as Opioid Receptor Modulators

[*]

YUGOSLAVIA (Serbia/Montenegro)

 

10182349.0

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

YUGOSLAVIA (Serbia/Montenegro)

 

12194058.9

03/15/2005

 

 Compounds as Opioid Receptor Modulators

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

PCT

 

PCT/US2005/008339

03/14/2005

 

Compounds as Opioid Receptor Modulators

N/A

SA

2006/8587

 

01/30/2008

 Compounds as Opioid Receptor Modulators34

[*]35

United Arab Emirates

 

405/2011

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Argentina

 

P0104133

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Australia

 

2009320156

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Brazil

 

P10920834-8

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Canada

 

2741790

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Chile

 

936/11

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

PRC

 

200980153642.2

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Columbia

 

11051582

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Costa Rica

 

2011-0286

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Eurasia Patent Convention

 

201170618

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Ecuador

 

SP-11-011008

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Egypt

 

636/2011

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

European Patent Convention

 

09752026.6

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Honduras

 

2011-001186

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Indonesia

 

WO201101496

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Israel

 

212464

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

India

 

1699/KOLNP/2011

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Japan

 

2011-534675

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

S. Korea

 

10-2011-7011699

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Mexico

 

MX/A/2011/004393

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Nicaragua

 

2011-000078

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

New Zealand

 

592415

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

New Zealand

 

604800

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Peru

 

939

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Philippines

 

1-2011-500818

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Singapore

 

201102907-1

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Taiwan

 

98136147

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Ukraine

 

201106621

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

US

 

12/606,730

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

South Africa

 

2011/03881

10/27/2009

 

PROCESS FOR THE PREPARATION OF PROTECTED L-ALANINE DERIVATIVES

N/A

Argentina

 

P060100973

3/14/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Australia

 

2006223394

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Azerbaijan

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Brazil

 

PI0607793-5

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Belarus

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID MODULATORS36

[*]

Canada

 

2601481

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

 

 

  [*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

Chile

 

0570/06

3/14/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Chile

 

2012-2068

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

China, People Republic

ZL200680016371.2

200680016371.2

3/6/2006

2/2/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Colombia

 

07095843

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Costa Rica

 

9438

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Eurasian Procedure

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Eurasian Procedure

 

06737611.1

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Ecuador

 

SP-07-7737-PCT

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Egypt

 

PCT963/2007

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

European Procedure

 

06737611.1

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Indonesia

 

WO021014599

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID MODULATORS37

N/A

Indonesia

 

W00201004601

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Indonesia

 

W002010046003/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Indonesia

ID0027689

W00200702972

3/6/2006

3/03/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Israel

 

209402

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Israel

 

185972

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

India

 

3419/KOLNP/07

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Japan

 

501919/08

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Kirghizistan

 

200701978

015512

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

S. Korea

10-1280929

10-2007-7022664

3/6/2006

06/25/2013

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

 

Kazakhstan

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Moldova Republic

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Mexico

 

MX/A/2007/011412

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Malaysia

MY-145333-A

PI200611103/6/2006

01/31/2012

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Nicaragua

 

2007-000237

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID MODULATORS38

N/A

Norway

 

20075269

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

New Zealand

590570

590570

3/6/2006

10/08/2012

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

New Zealand

 

561440

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Philippines

1-2007-502013

1-2007-502013

3/6/2006

11/02/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Russian Federation

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Tadjikistan

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Turkmenistan

015512

200701978

3/6/2006

8/30/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Taiwan

 

95108512

3/14/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Taiwan

 

101129655

8/16/2012

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

Ukraine

 

200710566/M

3/6/2006

 

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

N/A

US

7629488

11/368564

3/6/2006

12/8/2009

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Vietnam

9934

1-2007-01842

3/6/2006

12/20/2011

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

Vietnam

 

1-2011-01449

6/7/2011

10/4/2010

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

CO Patent Number Serial No. Issue Date Title Estimated Expiration Date

S Africa

2007/8810

2007/8810

3/6/2006

1/28/2009

PROCESS FOR THE PREPARATION OF OPIOID

MODULATORS

[*]

US

39

61/779,860

3/14/2013

 

Synthesis and Use of Dimethyl-Phenyl Cyano Compounds

N/A

US

 

13/829,984

3/14/2013

 

Opioid Receptor Modulator Dosage Formulations

N/A

 

 

Furiex has received seven Petitions for Invalidation of Korean Patent No. 719977
(entitled Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors
for Treating Sexual Dysfunction) that were filed with the IPT. The IPT has
rendered an opinion invalidating the patent. Patent counsel for Furiex is
addressing this decision and the possibility of a subsequent appeal at the court
level. Furiex has received an invalidation opinion from the PRB in China for
Chinese Patent No. ZL00815313.2 (entitled Methods of Using Rapid-Onset Selective
Serotonin Reuptake Inhibitors for Treating Sexual Dysfunction) and is appealing
the decision at the intermediate court level. Furiex does not believe that the
foregoing patents are material to its business and they do not relate to Nesina

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

 

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

 

 

 

Schedule 5.2(e)

 

LOCATION OF COLLATERAL

 

 

3900 Paramount Parkway, Suite 150

Morrisville, NC 27560

 

300 North Third Street

Wilmington, NC 28401

 

 

 

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SCHEDULE 5.3

 

LITIGATION

 

 

See Schedule 5.2(d).

 

 

 

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SCHEDULE 5.11

 

PRODUCTS AND REQUIRED PERMITS

 

 

1.

PRODUCTS

 

a.

Priligy

 

b.

JNJ-32729463

 

c.

JNJ-27018966

 

 

 

2.

REQUIRED PERMITS

 

 

a.

The following regulatory applications for performing human clinical trials:

 

(i)

Priligy - IND No. 34,909

 

(ii)

JNJ-32729463 - IND No. 102,844 (Tablets), IND No. 107,488 (IV)

 

(iii)

JNJ-27018966 - IND No. 79,214

 

 

 

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

 

 

  

SCHEDULE 6.14

 

POST CLOSING OBLIGATIONS

 

 

 

Borrowers shall satisfy and complete each of the following obligations, or
provide Agent each of the items listed below, as applicable, on or before the
date indicated below, all to the satisfaction of Agent in its sole and absolute
discretion:

 

(a)     By not later than twenty five (25) days after the Second Restatement
Date (or such later date as Agent shall agree in writing), Borrower shall
deliver a fully executed and complete amendment to that certain Uncertificated
Securities Control Agreement, dated as of October 17, 2011, by and among Furiex
Pharmaceuticals, Inc., Agent, Funds for Institutions Series, and State Street
Bank and Trust Company (the “ML Control Agreement”), which amendment shall
change the Account (as defined in the ML Control Agreement) from [*] to [*].

 

(b)     By not later than twenty five (25) days after the Second Restatement
Date (or such later date as Agent shall agree in writing), Borrower shall
deliver a fully executed and complete Control Agreement executed and delivered
by Borrower, Agent, Merrill Lynch and any other applicable Person required to be
a part of the Control Agreement with respect to the Collateral Account numbered
[*].40

 

 

 

Borrower’s failure to complete and satisfy any of the above obligations on or
before the date indicated above, or Borrower’s failure to deliver any of the
above listed items on or before the date indicated above, shall constitute an
immediate an automatic Event of Default.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.  

 

 

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SCHEDULE 7.4

 

INDEBTEDNESS AS OF THE RESTATEMENT DATE

 

 

None.

 

 
 

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

 

 

SCHEDULE 7.7

 

INVESTMENTS AS OF THE RESTATEMENT DATE

 

 

See the Collateral Accounts listed on Schedule 5.2(a) hereto.

 

Furiex Pharmaceuticals, Inc. has the following subsidiaries:

 

●

100% membership interest in APBI Holdings, LLC, a North Carolina limited
liability company

 

●

100% membership interest in Development Partners, LLC, a Delaware limited
liability company

 

●

500,000 shares of common stock of GenuPro, Inc., a North Carolina corporation
representing 100% of its issued and outstanding shares