Exhibit 10.1

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

PROMISSORY NOTE

 

 

$1,000,000.00

  Dated as of April 2, 2007

 

BioDelivery Sciences International (the “Company”) promises to pay to the order
of Hopkins Capital Group II, LLC (the “Lender”) the principal sum of One Million
Dollars and No cents ($1,000,000.00) in lawful money of the United States of
America, on the terms and conditions described below.

1.      Principal. The principal balance of this Note shall be repayable on
June 30, 2007.

2.      Interest. No interest shall accrue on the unpaid principal balance of
this Note.

3.      Application of Payments. All payments shall be applied first to payment
in full of any costs incurred in the collection of any sum due under this Note,
including (without limitation) reasonable attorney’s fees, then to the payment
in full of any late charges and finally to the reduction of the unpaid principal
balance of this Note.

4.      Events of Default. The following shall constitute Events of Default:

(a)      Failure to Make Required Payments. Failure by Company to pay the
principal of this Note within five (5) business days following the date when
due.

(b)      Voluntary Bankruptcy, Etc. The commencement by Company of a voluntary
case under the Federal Bankruptcy Code, as now constituted or hereafter amended,
or any other applicable federal or state bankruptcy, insolvency, reorganization,
rehabilitation or other similar law, or the consent by it to the appointment of
or taking possession by a receiver, liquidator, assignee, trustee, custodian,
sequestrator (or other similar official) of Company or for any substantial part
of its property, or the making by it of any assignment for the benefit of
creditors, or the failure of Company generally to pay its debts as such debts
become due, or the taking of corporate action by Company in furtherance of any
of the foregoing.

(c)      Involuntary Bankruptcy, Etc. The entry of a decree or order for relief
by a court having jurisdiction in the premises in respect of Company in an
involuntary case under the Federal Bankruptcy Code, as now or hereafter
constituted, or any other applicable federal or state bankruptcy, insolvency or
other similar law, or appointing a receiver, liquidator, assignee, custodian,
trustee, sequestrator (or similar official) of Company or for any substantial
part of its property, or ordering the winding-up

 

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or liquidation of its affairs, and the continuance of any such decree or order
unstayed and in effect for a period of 60 consecutive days.

5.      Remedies.

(a)      Upon the occurrence of an Event of Default specified in Section 4(a),
Lender may, by written notice to Company, declare this Note to be due and
payable, whereupon the principal amount of this Note, and all other amounts
payable hereunder, shall become immediately due and payable without presentment,
demand, protest or other notice of any kind, all of which are hereby expressly
waived, anything contained herein or in the documents evidencing the same to the
contrary notwithstanding.

(b)      Upon the occurrence of an Event of Default specified in Sections 4(b)
and 4(c), the unpaid principal balance of, and all other sums payable with
regard to, this Note shall automatically and immediately become due and payable,
in all cases without any action on the part of Lender.

6.      Waivers. Company and all endorsers and guarantors of, and sureties for,
this Note waive presentment for payment, demand, notice of dishonor, protest,
and notice of protest with regard to the Note, all errors, defects and
imperfections in any proceedings instituted by Lender under the terms of this
Note, and all benefits that might accrue to Company by virtue of any present or
future laws exempting any property, real or personal, or any part of the
proceeds arising from any sale of any such property, from attachment, levy or
sale under execution, or providing for any stay of execution, exemption from
civil process, or extension of time for payment; and Company agrees that any
real estate that may be levied upon pursuant to a judgment obtained by virtue
hereof, on any writ of execution issued hereon, may be sold upon any such writ
in whole or in part in any order desired by Lender.

7.      Unconditional Liability. Company hereby waives all notices in connection
with the delivery, acceptance, performance, default, or enforcement of the
payment of this Note, and agrees its liability shall be unconditional, without
regard to the liability of any other party, and shall not be affected in any
manner by any indulgence, extension of time, renewal, waiver or modification
granted or consented to by Lender, and consents to any and all extensions of
time, renewals, waivers, or modifications which may be granted by Lender with
respect to the payment or other provisions of this Note, and agrees that
additional Company, endorsers, guarantors, or sureties may become parties hereto
without notice to them or affecting their liability hereunder.

8.      Notices. Any notice called for hereunder shall be deemed properly given
if (i) sent by certified mail, return receipt requested, (ii) personally
delivered, (iii) dispatched by any form of private or governmental express mail
or delivery service providing receipted delivery or (iv) sent by telefacsimile
or (v) to the following addresses or to such other address as either party may
designate by notice in accordance with this Section:

 

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If to Company:

  BioDelivery Sciences International

  2501 Aerial Center Parkway

  Suite 205

  Morrisville, NC 27560

  Attn: Mark A. Sirgo, Pharm.D.

  Fax: (919) 653-5161

If to Lender:

  Hopkins Capital Group II, LLC

  324 Hyde Park Avenue

  Suite 350

  Tampa FL 33606

  Attn: Frank E. O’Donnell

  Fax: (813) 258-1658

Notice shall be deemed given on the earlier of (i) actual receipt by the
receiving party, (ii) the date shown on a telefacsimile transmission
confirmation, (iii) the date reflected on a signed delivery receipt, or (iv) two
(2) Business Days following tender of delivery or dispatch by express mail or
delivery service.

9.        Option To Enter Into Royalty Purchase. As further consideration for
the loan made by Lender evidenced hereby, Company and Lender each have the
right, to be exercised in such party’s sole discretion, to participate in and
enter into, and to cause the non-exercising party to participate in and enter
into, a royalty purchase agreement, on substantially similar terms and
conditions as set forth on Exhibit A attached hereto, for a period of six
(6) months from the date of this Note.

10.      Construction. THIS NOTE SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE
WITH THE DOMESTIC, INTERNAL LAW, BUT NOT THE LAW OF CONFLICT OF LAWS, OF THE
STATE OF NEW YORK.

11.      Severability. Any provision contained in this Note which is prohibited
or unenforceable in any jurisdiction shall, as to such jurisdiction, be
ineffective to the extent of such prohibition or unenforceability without
invalidating the remaining provisions hereof, and any such prohibition or
unenforceability in any jurisdiction shall not invalidate or render
unenforceable such provision in any other jurisdiction.

 

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IN WITNESS WHEREOF, Company, intending to be legally bound hereby, has caused
this Note to be duly executed by its Chief Executive Officer the day and year
first above written.

 

BIODELIVERY SCIENCES INTERNATIONAL

By:

 

/s/ Mark A. Sirgo

   

      Mark A. Sirgo

   

      President and Chief Executive Officer

 

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
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EXHIBIT A

Form of Royalty Purchase Agreement

 

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FORM OF

PURCHASE AGREEMENT

THIS PURCHASE AGREEMENT dated as of                     ,              (the
“Effective Date”), among Hopkins Capital Group II, LLC (“HCG”), BioDelivery
Sciences International, Inc. (“BioDelivery”), and Arius Pharmaceuticals, Inc., a
wholly-owned subsidiary of BioDelivery (“Subsidiary”, and together with
BioDelivery, the “Company”). HCG and Company are sometimes referred to herein
individually as a “Party” and collectively as “Parties”.

WHEREAS, Company is developing the compound currently identified as fentanyl in
conjunction with the BEMA Technology; and

WHEREAS, Company and HCG would like to set forth the terms and conditions
pursuant to which HCG shall pay the Company US$5,000,000 and, in return, upon
approval of the Fentanyl Product and subsequent commercialization of the
Fentanyl Product, Company shall make payments to HCG based upon, among other
things, revenue of the Company generated in connection with sales of the
Fentanyl Product.

NOW, THEREFORE, in consideration of the foregoing premises and the
representations, covenants and agreements contained herein, the Parties,
intending to be legally bound, hereby agree as follows:

ARTICLE 1

DEFINITIONS

The following terms, whether used in the singular or plural, shall have the
following meanings:

1.1       “Affiliate” means any Person directly or indirectly controlled by,
controlling or under common control with, a Party, but only for so long as such
control shall continue. For purposes of this definition, “control” (including,
with correlative meanings, “controlled by”, “controlling” and “under common
control with”) means, with respect to a Person, possession, direct or indirect,
of (a) the power to direct or cause direction of the management and policies of
such Person (whether through ownership of securities or partnership or other
ownership interests, by contract or otherwise), or (b) at least fifty percent
(50%) of the voting securities (whether directly or pursuant to any option,
warrant or other similar arrangement) or other comparable equity interests. For
the avoidance of doubt, neither of the Parties shall be deemed to be an
“Affiliate” of the other.

1.2       “Approval” means the approval by the relevant Governmental
Authority(ies) required for the initial launch, marketing and sale of a Product
for human therapeutic use in a particular jurisdiction (including but not
limited, in jurisdictions other than the United States, to all pricing and
reimbursement approvals).

1.3       “QLT” means QLT USA, Inc., a Delaware corporation.

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1.4      “QLT License” means that certain License Agreement executed between QLT
and Subsidiary, dated May 27, 2004, as amended, attached hereto as Schedule 1.4,
as the same may be amended from time to time.

1.5      “Arius Two License” means that certain License Agreement executed
between Subsidiary and Arius Two, Inc. (“Arius Two”), dated August 2, 2006, as
amended, attached hereto as Schedule 1.5, as the same may be amended from time
to time.

1.6      “BEMA” or “BEMA Technology” means (i) with respect to the United States
of America (and its territories and protectorates), the bioerodible mucoadhesive
drug delivery technology claimed in the Patent Rights licensed to Subsidiary
pursuant to the QLT License and (ii) with respect to all countries other than
the United States of America (and its territories and protectorates), the
bioerodible mucoadhesive drug delivery technology claimed in the Patent Rights
licensed to Subsidiary pursuant to the Arius Two License.

1.7      “Business Day” means a day that is not a Saturday, Sunday or a day on
which banking institutions in New York, New York are authorized by Law to remain
closed.

1.8      “Change of Control” shall mean a (a) change in ownership or control of
a Party effected through any of the following transactions: (i) a merger,
consolidation or other reorganization, unless securities representing more than
fifty percent (50%) of the total combined voting power of the voting securities
of the successor corporation are immediately thereafter beneficially owned,
directly or indirectly and in substantially the same proportion, by the persons
who beneficially owned such Party’s outstanding voting securities immediately
prior to such transaction, (ii) any transfer or other disposition of all or
substantially all of such Party’s assets, (iii) the acquisition, directly or
indirectly by any person or related group of persons (other than such Party or a
person that directly or indirectly controls, is controlled by, or is under
common control with, such Party), of beneficial ownership of securities
possessing more than fifty percent (50%) of the total combined voting power of
such Party’s outstanding securities or (b) a change in the power to direct or
cause the direction of the management and policies of a Party, directly or
indirectly, whether through ownership of voting securities or by contract or
otherwise.

1.9      “Commercially Reasonable Efforts” means, with respect to a Party, the
efforts which would be used by that Party consistent with its normal business
practices, which in no event shall be less than the level of efforts and
resources expended by comparable small cap biotechnology companies with respect
to a product or potential product at a similar stage in its development or
product life, taking into account product labeling, market potential, medical
and clinical considerations, the regulatory environment, financing environment,
patent and other proprietary position and competitive market conditions in the
therapeutic area, all as measured by the facts and circumstances at the time
such efforts are due.

1.10     “Company Patent Rights” means the Patent Rights Controlled by the
Company to the extent that they claim BEMA or Fentanyl Product, including
without limitation the Patent Rights set forth in Schedule 1.10.

 

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1.11      “Compound” means fentanyl, including without limitation metabolites or
prodrugs thereof, and any hydrates, conjugates, salts, esters, isomers,
polymorphs or analogues of any of the foregoing.

1.12      “Confidential Information” has the meaning set forth in Section 5.2.

1.13      “Control” means, when used in reference to intellectual property, the
possession of the ability to grant a license or sublicense as provided for
herein without (i) requiring the consent of a third party or (ii) violating the
terms of any agreement or other arrangement with any third party.

1.14      “Fentanyl Product” means, on a country-by-country and
product-by-product basis, any product covered by the Company Patent Rights in
the country of sale that contains the Compound alone or in combination with one
or more other substances.

1.15      “First Commercial Sale” means the first commercial sale, following
Approval, of a Product for human therapeutic use by the Company, an Affiliate
thereof, or any sublicensee of either of the foregoing.

1.16      “GAAP” means US generally accepted accounting principles.

1.17      “Governmental Authority” means any court, tribunal, arbitrator,
agency, department, legislative body, commission or other instrumentality of
(a) any government of any country, (b) any foreign, federal, state, county, city
or other political subdivision thereof or (c) any supranational body.

1.18      “Laws” means all laws, statutes, rules, codes, regulations, orders,
judgments and/or ordinances of any Governmental Authority.

1.19      “Net Sales” means the gross amounts billed or invoiced by Company and
its Affiliates, sublicensees and distributors, and each of their successors and
assigns, for sales of the Products throughout the world, less the following
deductions to the extent included in the gross invoiced sales price:

(a)     bona fide discounts (including but not limited to cash discounts, trade
discounts, quantity discounts, and prompt payment discounts), credits, rebates,
refunds, allowances, cost of free goods, adjustments, rejections, recalls and
returns, including rebates, refunds, allowances, or credits granted with respect
thereto, and charge-back payments granted to managed health care organizations
or to Governmental Authorities, their agencies, and purchasers and reimbursers
or to trade customers, recorded on the Company’s books in accordance with
generally accepted accounting principles, including but not limited to
wholesalers and chain and pharmacy buying groups, provided that such items
relate to the Product and only the portion of such items related to the Product
shall be deducted; and

(b)     taxes, tariffs and similar obligations, duties or other governmental
charges (other than income or corporation taxes) levied on, absorbed or
otherwise imposed on sales of the Product;

 

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If any such sales to third parties are made in transactions that are not at
arm’s length between the buyer and the seller, then the gross amount to be
included in the calculation of Net Sales shall be the amount that would have
been invoiced had the transaction been conducted at arm’s length, subject to
deductions set forth in subparagraphs (a) and (b) above. Such amount that would
have been invoiced shall be determined, wherever possible, by reference to the
average selling price of the relevant Product in arm’s-length transactions in
such country. Notwithstanding the foregoing, amounts received by Company or its
Affiliates, sublicensees or distributors for the sale of Products (i) among
Company and its Affiliates, sublicensees or distributors for resale or (ii) for
research or development purposes shall not, in either case, be included in the
computation of Net Sales hereunder. Net Sales shall be determined from books and
records maintained in accordance with GAAP, consistently applied throughout the
organization and across all products of the entity whose sales of Products are
giving rise to Net Sales.

Net Sales of a Combination Product (as defined below) shall be calculated as if
the invoiced sales price for a Product included within the Combination Product
is (i) the average sales price at which Company, its Affiliate, or a sublicensee
or distributor thereof sells, in the calendar quarter of the applicable sale,
the Product alone and not as a part of the Combination Product in the applicable
country or, if the Product is not offered in a country except as part of the
Combination Product, the average sales price at which the Product is sold alone
across all countries in which such Product is sold, or (ii) to the extent the
applicable Product has not been sold other than in a Combination Product, the
amount reasonably specified between Company or its Affiliate, sublicensee, or
distributor and any other party to an agreement regarding that Combination
Product as the portion of the sales price attributable to the Product. In the
event that Company includes a Product as part of a single bundled sale of
separate products with separately stated prices, the Net Sales attributable to
such Product shall be the higher of (i) the separately stated price stated for
such Product sold in such bundled sale or (ii) the average price at which such
Product is sold in the applicable country in a non-bundled sale or, if not sold
in the applicable country in a non-bundled sale, the average price at which such
Product is sold in a non-bundled sale across all countries in which such Product
is sold. For purposes of this paragraph, “Combination Product” means a Product
that is sold together with any other products and/or services at a unit price,
whether packaged together or separately with another pharmaceutical product or
other device, equipment, instrumentation, or other components (other than solely
containers or packaging exclusively for the Product).

1.20      “Other Products” means, on a country-by-country and product-by-product
basis, any products covered by Company Patent Rights that are not Fentanyl
Products.

1.21      “Patent Rights” means patents and patent applications and all
substitutions, divisions, continuations, continuations-in-part, any patent
issued with respect to any such patent applications, any reissue, reexamination,
renewal or extension (including any supplemental patent certificate) of any such
patent, and any confirmation patent or registration patent or patent of addition
based on any such patent, and all counterparts thereof in any country.

1.22      “Person” means any natural person or any corporation, company,
partnership, joint venture, firm or other entity, including without limitation a
Party.

 

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1.23      “Product” means Fentanyl Product or Other Product.

1.24      “Shortfall Amount” has the meaning set forth in Section 4.3.3.

ARTICLE 2

PRODUCT DEVELOPMENT; INTELLECTUAL PROPERTY

2.1      Development Diligence. Company shall use Commercially Reasonable
Efforts to develop a Fentanyl Product.

2.2      Intellectual Property. Company shall use Commercially Reasonable
Efforts to prepare, file, prosecute and maintain the Company Patent Rights owned
by Company. Where Company Patent Rights, are not owned by Company, Company shall
use Commercially Reasonable Efforts to enforce such Company Patent Rights in
accordance with the terms of the instrument or agreement granting Company such
rights.

ARTICLE 3

REGULATORY REPORTING

Company shall notify HCG promptly in writing upon (i) each receipt of an
Approval of Fentanyl Product in the United States or any member country of the
European Union, (ii) First Commercial Sale of Fentanyl Product in the United
States, and (iii) First Commercial Sale of Fentanyl Product in any member
country of the European Union.

ARTICLE 4

COMMERCIALIZATION AND FINANCIAL PROVISIONS

4.1      Commercialization Efforts. Company shall use Commercially Reasonable
Efforts to market, distribute, sell and otherwise commercialize the Fentanyl
Product.

4.2      Upfront Fees. HCG shall pay to Company an upfront payment amount of
Five Million Dollars ($5,000,000) upon execution of this Agreement as
consideration for the Company’s obligation to pay the amounts described below.

4.3      HCG Payments.

   4.3.1      Payments based on Net Sales. Commencing with respect to the first
calendar quarter following the First Commercial Sale of a Fentanyl Product in
the United States, Company will pay to HCG, on a quarterly basis, an amount
based upon Net Sales of Fentanyl Products in the United States as follows:

(a)      **** of the first **** of Net Sales of Fentanyl Products in the United
States; and

(b)      **** of Net Sales of Fentanyl Products in the United States exceeding
the first **** of Net Sales of Fentanyl Products in the United States.

 

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4.3.2      Minimum HCG Payments. Commencing with respect to the first complete
calendar year following the First Commercial Sale of a Fentanyl Product, if the
payments made by Company to HCG pursuant to Section 4.3.1 with respect to any
particular calendar year hereunder are less than ****, Company shall pay to HCG
an amount equal to the difference between **** and the aggregate payments
previously paid to HCG with respect to such calendar year (the “Shortfall
Amount”), which Shortfall Amount payment shall be made to HCG at the time the
payment for the fourth calendar quarter of such calendar year is paid to HCG
pursuant to the terms of Section 4.3.6. Notwithstanding the foregoing, (i) the
Company’s obligations under this Section 4.3.2 shall terminate once the
Company’s total payments to HCG under this Agreement total **** and (ii) the
Company shall not be required to pay any amounts to HCG under this Section 4.3.2
to the extent such payment would cause the Company’s payments to HCG under this
Agreement to exceed ****.

4.3.3      No US Fentanyl Product Approval. If Approval of the Fentanyl Product
in the United States is not obtained by December 31, 2008 but Approval of the
Fentanyl Product is obtained in any country of the European Union prior to
June 30, 2009, then, notwithstanding anything to the contrary, (i) the Company’s
payment obligations under Sections 4.3.1 and 4.3.2 shall terminate and
(ii) commencing with respect to the later of (A) the third calendar quarter of
2009 or (B) the first calendar quarter following the First Commercial Sale of a
Fentanyl Product in the European Union, Company will pay to HCG, on a quarterly
basis, an amount based upon Net Sales of Fentanyl Products as follows:

(a)      **** of the first **** of Net Sales of Fentanyl Products in the
European Union and United States; and

(b)      **** of Net Sales of Fentanyl Products in the European Union exceeding
the first **** of Net Sales of Fentanyl Products in the European Union and
United States.

4.3.4      Termination Payment. The Company shall have the right, at any time,
to terminate all payment obligations to HCG under this Agreement by providing
written notice to HCG and paying HCG an amount equal to the greater of (i) ****
or, if such notice is given after the Company’s first quarterly payment under
Section 4.3.1 or 4.3.3 of this Agreement, (ii) an amount equal to the product of
**** times the amount of the most recent quarterly payment paid to HCG pursuant
to Section 4.3.5 (excluding, for purposes of such calculation, any amounts paid
by the Company to HCG under Section 4.3.2 above). For purposes of clarification
but not limitation, if the Company exercises the right provided under this
Section 4.3.4 prior to its first payment to HCG under Section 4.3.1 or 4.3.3,
the Company may exercise such right by providing notice and a payment of **** to
HCG. Upon providing notice and payment to HCG under this Section 4.3.4, this
Agreement and all payment obligations of the Company under this Agreement shall
terminate.

Notwithstanding anything to the contrary contained in this Section, the Company
shall have the right, at any time, to refund to HCG the upfront payment amount
of Five Million

 

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Dollars ($5,000,000) to the extent that the Company has received notice from any
regulatory authority that this Agreement violates any foreign, federal, state or
local statute, law, rule or regulation, or to the extent that the Company has
received an opinion of counsel that this Agreement is a material violation of
any agreement or instrument to which the Company is a party. Upon payment of
such amount to HCG by the Company, this Agreement shall terminate and neither
party shall have any claim or right or action against the other party.

4.3.5      Timing of Payments. All amounts due HCG pursuant to Section 4.3.1 or
4.3.3, as applicable, shall be payable quarterly in arrears and such payments
shall be made by Company to HCG within ninety (90) days after March 31, June 30,
September 30 and December 31 of each year. Each quarterly payment shall be
accompanied by a written statement as described in Section 4.3.6.

4.3.6      Written Statement. Along with each remittance of payments pursuant to
Section 4.3.1 or 4.3.3 to HCG, Company shall include a report covering: (i) the
gross sales of all Products subject to this Agreement sold by Company, its
Affiliates and sublicensees, (ii) the Net Sales of all Products subject to this
Agreement sold by Company, its Affiliates and its sublicensees, during the
calendar quarter and the detailed calculation of the reconciliation between
gross sales and Net Sales subject to this Agreement, showing those items allowed
to be deducted from gross sales pursuant to the definition of Net Sales;
(iii) the amounts payable in US Dollars with respect to Net Sales subject to
this Agreement; (iv) the exchange rates used in determining the amount of
Dollars. If no sales of Products subject to this Agreement have been made during
any reporting period, Company will provide a statement to this effect to HCG.

4.3.7      HCG Warrant. The Company shall simultaneously with the execution
hereof transfer to HCG a warrant for the purchase of Four Hundred Seventy Five
Thousand (475,000) shares of Common Stock of the Company with a strike price of
Five Dollars and Fifty Five Cents ($5.55) per share with a term extending until
the date which is two years from the date of the first Approval of a Product.

4.4      Payment Currency. All amounts due under this Agreement shall be paid to
the designated Party in United States dollars. The US dollar equivalent of Net
Sales incurred in a currency other than U.S. Dollars shall be calculated using
the methodology set forth in any license, strategic or collaborative partnership
agreement with a third party generating such sales, or otherwise using the
average of the spot rate (the “Closing mid-point rates” found in the “Dollar
spot forward against the Dollar” table published by The Financial Times, or any
other publication agreed to by the Parties) prevailing during the calendar
quarter of the applicable payment.

4.5      Payments. All payments under this Agreement shall be made on or before
the due date by electronic transfer in immediately available funds to the
respective account designated in writing by HCG prior to such payment. All
payments under this Agreement shall bear interest from thirty days following the
date due until paid at a rate equal to one half of one percent per month
calculated on the number of days such payments are paid after the date such
payments are due.

 

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4.6      Books and Records. Company shall keep comprehensive books and records
relating to this Agreement in accordance with GAAP. Such books and records shall
document all gross sales and Net Sales, and include all information subject to
audit pursuant to Section 4.7. All such books and records shall be maintained
for three (3) years following the relevant year or such longer period as is
required by Law.

4.7      Audits. These audit and adjustment provisions apply with respect to all
payments due or owing pursuant to this Agreement. HCG shall have the right to
have the applicable books and records of Company audited under appropriate
confidentiality provisions for the sole purpose of verifying the accuracy of all
financial, accounting and numerical information and calculations under this
Agreement. Any such audit shall be conducted no more than once each year, and
upon at least twenty (20) Business Days’ advance notice during normal business
hours and in a manner that does not interfere unreasonably with the business of
Company. The results of any such audit shall be delivered in writing to each
Party. Any underpayment or overbilling determined by such audit shall promptly
be paid or refunded by Company. If Company has underpaid or overbilled amounts
due under this Agreement by more than five percent (5%) over any reporting
period, Company shall also reimburse HCG for the cost of such audit (with the
cost of the audit to be paid by HCG in all other cases), plus interest in
accordance with Section 4.5, from the date of any such underpayment or
overpayment.

4.8      Withholding; Taxes. Notwithstanding anything to the contrary, in the
event any of the payments made by Company pursuant to this Article 4 become
subject to withholding taxes under the laws of any jurisdiction, such amounts
payable shall be reduced by the amount of taxes deducted and withheld, and
Company shall pay the amounts of such taxes to the proper Governmental Authority
in a timely manner and promptly transmit to HCG an official tax certificate or
other evidence of such tax obligations together with proof of payment from the
relevant Governmental Authority of all amounts deducted and withheld sufficient
to enable HCG to claim such payment of taxes. Any such withholding taxes
required under applicable law to be paid or withheld shall be an expense of, and
borne solely by, HCG. Company will provide HCG with reasonable assistance, at
HCG’ expense, to enable HCG to recover such taxes as permitted by law.

4.9      Blocked Currency. Notwithstanding anything to the contrary, in each
country where the local currency is blocked and cannot be removed from the
country under such country’s applicable law, amounts accrued in that country
shall be paid to HCG in such country in local currency by deposit in a local
bank designated by HCG, unless the Parties otherwise agree.

4.10    HCG Repayment Right. Notwithstanding anything herein to the contrary,
during the period: (a) beginning from the date that the Company secures a
commercial partner for a Fentanyl Product, and at which point such commercial
partner provides cumulatively at least **** of payments (a “Fentanyl Product
Payment”) and (b) ending upon the Company’s public announcement of the
commercial launch of such Fentanyl Product, HCG may exercise a right (the
“Repayment Right”), by written notice to the Company, to terminate this
agreement and require that the Company refund to HCG an amount equal to Five
Million Dollars ($5,000,000). It is agreed that in the event a commercial
partner for a Fentanyl Product is not secured and/or a cumulative Fentanyl
Product Payment equal to at least

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

**** is not secured, HCG may nonetheless exercise its Repayment Right at any
time after January 1, 2009 and prior to the close of business on June 30, 2009.
The Company agrees that, in the event it receives the Fentanyl Product Payment,
it shall place Five Million Dollars ($5,000,000) of such Fentanyl Product
Payment in a restricted bank account and shall not, without the prior written
consent of HCG, draw upon or utilize such funds until the expiration of the
Repayment Right.

ARTICLE 5

CONFIDENTIAL INFORMATION

5.1    Treatment of Confidential Information. During the term of this Agreement
and for five (5) years thereafter, HCG shall maintain Confidential Information
(as defined in Section 5.2) of the Company in confidence, and shall not
disclose, divulge or otherwise communicate such Confidential Information to
others (except for employees, agents and advisors under obligations of
confidentiality) or use it for any purpose other than for tax or accounting
purposes, and HCG agrees to exercise reasonable efforts to prevent and restrain
the unauthorized disclosure of such Confidential Information by any of its
directors, officers, employees, consultants, subcontractors, licensees, auditors
or agents, which reasonable efforts shall be at least as diligent as those
generally used by HCG in protecting its own confidential and proprietary
information. HCG acknowledges that the confidentiality provisions of this
Agreement shall be deemed to be an agreement to keep the Confidential
Information in confidence as contemplated by Regulation FD promulgated by the
Securities and Exchange Commission. In addition, HCG acknowledges and agrees
that some of the Confidential Information may be considered “material non-public
information” for purposes of the federal securities laws (“Insider Information”)
and that HCG and its officers, employees, agents and affiliates will abide by
all securities laws relating to the handling of and acting upon Insider
Information.

5.2    Confidential Information. “Confidential Information” means all trade
secrets or other proprietary information, including without limitation any
proprietary data and materials (whether or not patentable or protectable as a
trade secret), regarding Company’s technologies, products, business or
objectives or regarding the Products or otherwise (including the Company’s
business plans and results of operations generally), which is disclosed by
Company to HCG. Notwithstanding the foregoing, there shall be excluded from the
foregoing definition of Confidential Information any of the foregoing that:

 5.2.1      either before or after the date of the disclosure to HCG is lawfully
disclosed to HCG, with no obligation of confidentiality, by third parties not in
violation of any obligation to the Company; or

 5.2.2      either before or after the date of the disclosure to HCG becomes
published or generally known to the public through no fault or omission on the
part of HCG or its Affiliates; or

 5.2.3      is required to be disclosed by HCG to comply with applicable
securities and other Laws, to defend or prosecute litigation or to comply with
governmental regulations or the regulations or requirements of any stock
exchange, provided that HCG

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

provides prior notice of such disclosure to the Company and, subject to the
reasonable advice and comment of the Company, takes reasonable and lawful
actions to avoid and/or minimize the degree of such disclosure.

5.3      Confidentiality of this Agreement. The material financial terms of this
Agreement shall be Confidential Information of the Company and, as such, shall
be subject to the provisions of this Article 5.

5.4      Registration and Filing of the Agreement. To the extent, if any, that a
Party concludes in good faith that it is required to file or register this
Agreement or a notification thereof with any Governmental Authority, including
without limitation the US Securities and Exchange Commission, or the US Federal
Trade Commission, in accordance with applicable Laws, such Party shall inform
the other Party thereof. Should either Party be required to submit or obtain any
such filing, registration or notification, they shall cooperate, each at its own
expense, in such filing, registration or notification and shall execute all
documents reasonably required in connection therewith. In such filing,
registration or notification, the Parties shall use commercially reasonable
efforts to agree in advance on which provisions of this Agreement they will
request confidential treatment of. The Parties shall promptly inform each other
as to the activities or inquiries of any such Governmental Authority relating to
this Agreement, and shall reasonably cooperate to respond to any request for
further information therefrom on a timely basis.

5.5      Press Releases and Other Disclosures. No press release or other public
announcement concerning the existence or terms of this Agreement shall be made,
either directly or indirectly, by either Party hereto, without first obtaining
the written approval of the other Party. Once any public announcement or
disclosure has been approved in accordance with this Section, then either Party
may appropriately communicate information contained in such permitted
announcement or disclosure. Notwithstanding the foregoing provisions of this
Article 5, Company may (a) disclose the existence and terms of this Agreement
where required, as reasonably determined by Company, by applicable Law, by
applicable stock exchange or Nasdaq regulation or by order or other ruling of a
competent court and (b) disclose the existence and terms of this Agreement under
obligations of confidentiality to auditors, legal counsel and investment bankers
in connection with exploring the issuance of securities in a public transaction.
Notwithstanding the foregoing provisions of this Section Article 5, HCG may
(a) disclose the existence and terms of this Agreement where required, as
reasonably determined by the HCG, by applicable Law, by applicable stock
exchange or Nasdaq regulation or by order or other ruling of a competent court
and (b) disclose the existence and terms of this Agreement under obligations of
confidentiality to agents, auditors, advisors, contractors and investors and to
potential agents, auditors, advisors, contractors and investors in connection
with such HCG’ activities hereunder and in connection with such Party’s
financing activities.

ARTICLE 6

REPRESENTATIONS AND WARRANTIES

6.1      Mutual Representations and Warranties. Company and HCG each represents
and warrants that it (a) is duly organized, validly existing, and in good
standing under the Laws of its incorporation; (b) is duly qualified and in good
standing under the Laws of each

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

jurisdiction where its ownership or lease of property or the conduct of its
business requires such qualification, where the failure to be so qualified would
have a material adverse effect on its financial condition or its ability to
perform its obligations hereunder; (c) has the requisite corporate power and
authority and the legal right to conduct its business as now conducted and
hereafter contemplated to be conducted; (d) has or will obtain all necessary
licenses, permits, consents, or approvals from or by, and has made or will make
all necessary notices to, all Governmental Authorities having jurisdiction over
such Party, to the extent required for the ownership and operation of its
business, where the failure to obtain such licenses, permits, consents or
approvals, or to make such notices, would have a material adverse effect on its
financial condition or its ability to perform its obligations hereunder; and
(e) is in compliance with its charter documents.

6.2      Acknowledgement by the Parties. Company and HCG each hereby warrants,
represents and acknowledges that this Agreement and the obligations of the
Company under this Agreement do not involve the sale, license, encumbrance or
other transfer of any specific asset or right of the Company and that the
obligation to make payments hereunder is a general obligation of the Company and
not an encumbrance on any Company asset. HCG acknowledges and agrees that this
Agreement does not grant to HCG any security interest in or to any asset or
right of the Company and that the references to specific assets under this
Agreement are included solely for the purpose of determining the timing and
amount of payments due to HCG hereunder. By entering into this Agreement, HCG
acknowledges that the Company has (i) previously granted a security interest in
certain assets that will be used to determine the timing and amount of payments
under this Agreement; and (ii) has full power, right and authority to sell,
transfer, license or encumber in any manner, any of the assets of the Company,
subject to restrictions or limitations contained in any of the Company’s
agreements existing as of the date hereof.

ARTICLE 7

LIMITATION ON LIABILITY

NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL,
SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF
THIS AGREEMENT, OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF
THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

ARTICLE 8

TERM AND TERMINATION

8.1    Term. This Agreement shall be effective as of the Effective Date and,
unless terminated earlier pursuant to Section 4.3.4 above, shall continue in
force until, on a country-by-country and product-by-product basis, the
expiration of the last Valid Claim of an applicable Company Patent Right
covering such product in such country.

8.2    Accrued Rights; Surviving Obligations. Notwithstanding any termination or
expiration of this Agreement, neither Party shall be relieved of any obligations
incurred prior to such termination or expiration, including without limitation
payment obligations accrued prior to

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

such termination, provided that, notwithstanding the foregoing, in the event of
a termination pursuant to Section 4.3.4 above, the Company shall be relieved of
all payment obligations upon such termination except (i) the payment due under
Section 4.3.4 and (ii) any quarterly payments overdue at the time of such
termination. Sections 1, 5, 7, and 9 will survive termination or expiration of
this Agreement. Upon any termination or expiration of this Agreement HCG shall
promptly return to the Company all written Confidential Information, and all
copies thereof, of the Company.

ARTICLE 9

MISCELLANEOUS

9.1      Governing Law. This Agreement shall be governed by and interpreted in
accordance with the internal laws of the State of New York, without regard to
its conflicts of laws rules. The parties to this Agreement each consent to the
in personam jurisdiction and venue of such courts. The parties agree that
service of process upon them in any such action may be made if delivered in
person, by courier service, by telegram, by telefacsimile or by first class
mail, and shall be deemed effectively given upon receipt.

9.2      Waiver. Waiver by a Party of a breach hereunder by the other Party
shall not be construed as a waiver of any succeeding breach of the same or any
other provision. No delay or omission by a Party to exercise or avail itself of
any right, power or privilege that it has or may have hereunder shall operate as
a waiver of any right, power or privilege by such Party. No waiver shall be
effective unless made in writing with specific reference to the relevant
provision(s) of this Agreement and signed by a duly authorized representative of
the Party granting the waiver.

9.3      Notices. All notices, instructions and other communications hereunder
or in connection herewith shall be in writing, shall be sent to the address
below and shall be: (a) delivered personally; (b) sent by registered or
certified mail, return receipt requested, postage prepaid; (c) sent via a
reputable nationwide overnight courier service; or (d) sent by facsimile
transmission. Any such notice, instruction or communication shall be deemed to
have been delivered upon receipt if delivered by hand, three (3) Business Days
after it is sent by registered or certified mail, return receipt requested,
postage prepaid, one (1) Business Day after it is sent via a reputable
nationwide overnight courier service, or when transmitted with electronic
confirmation of receipt, if transmitted by facsimile (if such transmission is on
a Business Day; otherwise, on the next Business Day following such
transmission).

Notices to Company shall be addressed to:

BioDelivery Sciences International, Inc.

2501 Aerial Center Parkway, Suite 205

Morrisville, NC 27560

Facsimile: 919-653-5161

Attention: Mark A. Sirgo, Pharm.D.

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

  Notices to HCG shall be addressed to:

  Hopkins Capital Group II, LLC

  324 South Hyde Park Ave., Suite 350

  Tampa, Florida 33606

  Facsimile: (813) 258-6912

Either Party may change its address by giving notice to the other Party in the
manner provided above.

9.4      Entire Agreement. This Agreement (including Schedules) and the Warrant
contains the complete understanding of the Parties with respect to the subject
matter herein and supersedes all prior understandings and writings relating to
such subject matter. This Agreement may be altered, amended or changed only by a
writing making specific reference to this Agreement and signed by duly
authorized representatives of Company and HCG.

9.5      Headings. Headings in this Agreement are for convenience of reference
only and shall not be considered in construing this Agreement.

9.6      Severability. If any provision of this Agreement is held unenforceable
by a court or tribunal of competent jurisdiction because it is invalid or
conflicts with any Law of any relevant jurisdiction, the validity of the
remaining provisions shall not be affected. In such event, the Parties shall
negotiate a substitute provision that, to the extent possible, accomplishes the
original business purpose.

9.7      Assignment. Except as otherwise provided herein, neither this Agreement
nor any of the rights or obligations hereunder may be assigned by Company
without the prior consent of HCG; provided, however, that Company may assign
this Agreement to an Affiliate or upon a Change of Control of Company without
the consent of the other Party. Any attempted assignment by Company in violation
hereof shall be void.

9.8      Successors and Assigns. This Agreement shall be binding upon and inure
to the benefit of the Parties hereto and their respective successors and
permitted assigns, including without limitation, any successor or assignee of
the Company Intellectual Property, who shall be bound by the obligations of
Company in this Agreement.

9.9      Counterparts; Facsimile Signatures. This Agreement may be executed in
two counterparts, each of which shall be deemed an original, but both of which
together shall constitute one and the same instrument. Signatures provided by
facsimile transmission shall be deemed to be original signatures.

9.10    Third-Party Beneficiaries. None of the provisions of this Agreement
shall be for the benefit of or enforceable by any third party, including,
without limitation, any creditor of either Party. No such third party shall
obtain any right under any provision of this Agreement or shall by reason of any
such provision make any claim in respect of any debt, liability or obligation
(or otherwise) against either Party.

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

9.11      Relationship of the Parties. Each Party shall bear its own costs
incurred in the performance of its obligations hereunder without charge or
expense to the other, except as expressly provided in this Agreement. Neither
Party shall have any responsibility for the hiring, termination or compensation
of the other Party’s employees or for any employee compensation or benefits of
the other Party’s employees. No employee or representative of a Party shall have
any authority to bind or obligate the other Party to this Agreement for any sum
or in any manner whatsoever, or to create or impose any contractual or other
liability on the other Party without said other Party’s approval. Nothing in
this Agreement shall be construed to establish a relationship of partners or
joint venturers between the Parties.

[SIGNATURE PAGE FOLLOWS]

 

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Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

IN WITNESS WHEREOF, the Parties have signed this Agreement as of the Effective
Date.

 

BIODELIVERY SCIENCES

INTERNATIONAL, INC.

By:

 

 

 

    Name:

 

    Title:

ARIUS PHARMACEUTICALS, INC.

By:

 

 

 

    Name:

 

    Title:

HOPKINS CAPITAL GROUP II, LLC

By:

 

 

 

    Name:

 

    Title:

 

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

SCHEDULE 1.4

QLT LICENSE

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

SCHEDULE 1.5

ARIUS TWO LICENSE

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

SCHEDULE 1.10

COMPANY PATENT RIGHTS

 

Docket Number/Subcase

Case Type

 

        Country

        Client

  

Application/Patent

Number/Date

 

Status

Publication Date

BSZ-0076-1/

 

        United States of America

  

60/750191

 

Pending

PRO

 

        BioDelivery Sciences Interntl, Inc.

  

13-Dec-2005

   

Title:  ABUSE RESISTANT TRANMUCOSAL DRUG DELIVERY DEVICE

BSZ-0076-2/

 

        United States of America

  

60/764619

 

Pending

PRO

 

        BioDelivery Sciences Interntl, Inc.

  

02-Feb-2006

   

Title:  ABUSE RESISTANT TRANMUCOSAL DRUG DELIVERY DEVICE

BSZ-0088-1/

 

        United States of America

  

60/832725

 

Pending

PRO

 

        BioDelivery Sciences Interntl, Inc.

  

21-Jul-2006

   

Title:  TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE

BSZ-0088-2/

 

        United States of America

  

60/839504

 

Pending

PRO

 

        BioDelivery Sciences Interntl, Inc.

  

23-Aug-2006

   

Title:  TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE

BSZ-0089-1/

 

        United States of America

  

60/832726

 

Pending

PRO

 

        BioDelivery Sciences Interntl, Inc.

  

21-Jul-2006

   

Title:  TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE

BSZ-0092CA/

 

        Canada

  

2268187

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

16-Oct-1997

   

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092CPDVCN/

 

        United States of America

  

10/962833

 

Published

CON

 

        BioDelivery Sciences Interntl, Inc.

  

12-Oct-2004

 

03-Mar-2005

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092CPDVCN2/

 

        United States of America

  

11/069089

 

Published

CON

 

        BioDelivery Sciences Interntl, Inc.

  

01-Mar-2005

 

07-Jul-2005

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

BSZ-0092CPDVRCE/

 

        United States of America

  

09/684682

 

Pending

RCE

 

        BioDelivery Sciences Interntl, Inc.

  

04-Oct-2000

   

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACE

BSZ-0092CPRCE/

 

        United States of America

  

09/069703

 

Pending

CIP

 

        BioDelivery Sciences Interntl, Inc.

  

29-Apr-1998

   

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092JP/

 

        Japan

  

98519467

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

16-Oct-1997

   

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092JPDV/

 

        Japan

  

2005182632

 

Pending

DIV

 

        BioDelivery Sciences Interntl, Inc.

  

16-Oct-1997

   

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2CA/

 

        Canada

  

2329128

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

29-Apr-1999

   

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2JP/

 

        Japan

  

2000-054511

 

Published

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

29-Apr-1999

 

08-May-2002

 

Title:  BIOERODABLE FILM FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO

 

        MUCOSAL SURVACES

    

BSZ-0092PC2JPDV/

 

        Japan

  

2005233505

 

Published

DIV

 

        BioDelivery Sciences Interntl, Inc.

  

29-Apr-1999

 

24-Nov-2005

 

Title:  BIOERODABLE FILM FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO

 

        MUCOSAL SURVACES

    

BSZ-0093AU/

 

        Australia

  

200426264974

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

20-Feb-2006

   

Title:  ADHESIVE BIOERODIBLE TRANSMUCOSAL DRUG DELIVERY SYSTEM

BSZ-0093CA/

 

        Canada

  

2535846

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

16-Aug-2004

   

Title:  ADHESIVE BIOERODIBLE TRANSMUCOSAL DRUG DELIVERY SYSTEM

BSZ-0093CN/

 

        United States of America

  

11/355312

 

Pending

CON

 

        BioDelivery Sciences Interntl, Inc.

  

15-Feb-2006

   

Title:  ADHESIVE BIOERODIBLE TRANSMUCOSAL DRUG DELIVERY SYSTEM

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

BSZ-0093EP/

 

        European Patent Convention

  

04 78 1250.8

 

Published

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

16-Aug-2004

 

31-May-2006

 

Title:  ADHESIVE BIOERODIBLE TRANSMUCOSAL DRUG DELIVERY SYSTEM

BSZ-0093JP/

 

        Japan

  

2006-523962

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

16-Aug-2004

   

Title:  ADHESIVE BIOERODIBLE TRANSMUCOSAL DRUG DELIVERY SYSTEM

BSZ-0093MX/

 

        Mexico

  

PA/a/2006/001776

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

16-Aug-2004

   

Title:  ADHESIVE BIOERODIBLE TRANSMUCOSAL DRUG DELIVERY SYSTEM

BSZ-0094AU/

 

        Australia

  

2003000238670

 

Pending

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

11-Apr-2003

   

Title:  PROCESS FOR LOADING A DRUG DELIVERY DEVICE

BSZ-0095/

 

        United States of America

  

10/763063

 

Pending

PRI

 

        BioDelivery Sciences Interntl, Inc.

  

22-Jan-2004

   

Title:  BIOERODIBLE FILM FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO

 

        MUCOSAL SURFACES

    

BSZ-0092/

 

        United States of America

  

5800832

 

Granted

PRI

 

        BioDelivery Sciences Interntl, Inc.

  

01-Sep-1998

 

  18-Oct-2016

 

Title:  BIOERODABLE FILM FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO

 

        MUCOSAL SURVACES

    

BSZ-0092AT/

 

        Austria

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092AU/

 

        Australia

  

729516B

 

Granted

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

17-May-2001

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092AUDV/

 

        Australia

  

769500

 

Granted

DIV

 

        BioDelivery Sciences Interntl, Inc.

  

13-May-2004

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

BSZ-0092BE/

 

        Belgium

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092CH/

 

        Switzerland

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092CN/

 

        United States of America

  

6159498

 

Granted

CON

 

        BioDelivery Sciences Interntl, Inc.

  

12-Dec-2000

 

  18-Oct-2016

 

Title:  BIOERODABLE FILM FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO

 

        MUCOSAL SURFACES

BSZ-0092DE/

 

        Germany

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092DK/

 

        Denmark

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092EP/

 

        European Patent Convention

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092ES/

 

        Spain

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092FI/

 

        Finland

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092FR/

 

        France

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

BSZ-0092GB/

 

        United Kingdom

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092GR/

 

        Greece

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:   PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092IE/

 

        Ireland

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:   PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092IT/

 

        Italy

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092NL/

 

        Netherlands

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2AT/

 

        Austria

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2AU/

 

        Australia

  

746339B

 

Granted

PCT

 

        BioDelivery Sciences Interntl, Inc.

  

01-Aug-2002

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2BE/

 

        Belgium

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2CH/

 

        Switzerland

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

BSZ-0092PC2DE/

 

        Germany

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2DK/

 

        Denmark

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2EP/

 

        European Patent Convention

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2ES/

 

        Spain

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2FI/

 

        Finland

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2FR/

 

        France

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2GB/

 

        United Kingdom

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2GR/

 

        Greece

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2IE/

 

        Ireland

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

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

Confidential Treatment Requested For Portions of This Exhibit Denoted With
“****”

 

BSZ-0092PC2IT/

 

        Italy

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2LU/

 

        Luxembourg

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2NL/

 

        Netherlands

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2PT/

 

        Portugal

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092PC2SE/

 

        Sweden

  

1079813

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

09-Feb-2005

 

  29-Apr-2019

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES

BSZ-0092SE/

 

        Sweden

  

973497

 

Granted

EPC

 

        BioDelivery Sciences Interntl, Inc.

  

11-Dec-2002

 

  16-Oct-2017

 

Title:  PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF

 

        PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES