Exhibit 10.1
Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
***CONFIDENTIAL TREATMENT REQUESTED***
Note: Confidential treatment requested with respect to certain portions hereof denoted with “***”
MEDA AB
- and -
BIODELIVERY SCIENCES INTERNATIONAL, INC
ASSIGNMENT
AND REVENUE SHARING
AGREEMENT
Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
ASSIGNMENT AGREEMENT
(the
“Agreement”
) is dated January 23, 2015, and is made by and between:
P
ARTIES
|
(1)
|
MEDA AB
,
a corporation organised under the laws of Sweden, having its principal offices at Pipers Våg 2A, SE-170 73 Solna, Sweden (“
Meda
”);
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(2)
|
BIODELIVERY SCIENCES INTERNATIONAL, INC.
, a Delaware corporation, which has principal offices at 801 Corporate Center Drive, Suite 210, Raleigh, NC 27607, USA (“
BDSI Parent
”); and
|
|
(3)
|
ARIUS PHARMACEUTICALS, INC.
, a Delaware corporation and wholly-owned subsidiary of BDSI, having the same address as BDSI (“
Arius
”; collectively, with BDSI Parent, “
BDSI
”).
|
B
ACKGROUND
|
(A)
|
BDSI and Meda entered into a License and Development Agreement on 5 September 2007 (as amended, the “
D&L Agreement
”) for the development and commercialisation of a BEMA formulation of fentanyl
in North America. The product has the trade name ONSOLIS®
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(B)
|
The NDA for the ONSOLIS® product was granted on 16 July 2009. As of the Effective Date, the NDA is held by Meda.
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(C)
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Meda and BDSI have agreed that BDSI shall, at its cost, use Commercially Reasonable Efforts to attempt to resolve issues raised with respect to ONSOLIS® relating to the formation of microscopic crystals and a fading
of the colour in order to obtain approval by the FDA of an amended NDA reflecting any revised formulation or other changes necessary to resolve such issues, provided that BDSI shall not have any obligations to perform any research, development, or
manufacturing work in undertaking such efforts.
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(D)
|
The Parties have further agreed that BDSI should seek a replacement licensee for ONSOLIS® in North America and that Meda will facilitate the grant of a new license concerning ONSOLIS®, and the transfer certain
related assets and rights, to BDSI and/or the replacement licensee, as further described in a Termination Agreement (as defined below) to be negotiated and executed by the Parties as described herein, provided that Meda shall be reimbursed for its
expenses and payments made under the D&L Agreement from certain BDSI receipts pursuant to the New License, consistent with the terms of this Agreement, as shall be further described in such Termination Agreement.
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A
GREED
TERMS
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1.1
|
The definitions and rules of interpretation in this clause apply in this Agreement. Where a capitalised term is not defined in this Agreement it shall have the meaning set out in the D&L Agreement.
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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1.2
|
“CDC Royalty”
means the lesser of: (i) payments to be made by BDSI pursuant to Section 6.6.1 and, if applicable for any period during which Licensed Products are sold in the Territory, 6.6.3
of that certain Clinical Development and License Agreement, dated July 14, 2005, as amended, among CDC V, LLC (“CDC”), BDSI Parent, Arius and Arius Two, Inc. (the “
CDC Agreement
”); (ii) in the event of any
amendment of the CDC Agreement following the Effective Date that increases payments due under Section 6.6.1 and/or 6.6.3 thereof for any period, the payments that would have been due by BDSI for such period pursuant to Sections 6.6.1 and, if
applicable for any portion of such period during which Licensed Products are sold in the Territory, 6.6.3 of the CDC Agreement under the terms thereof as the CDC Agreement existed as of the Effective Date, absent the effects of such later amendment
thereto; and (iii)
***
of Net Sales (as defined in the CDC Agreement) (“
CDC Net Sales
”).
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1.3
|
“D&L Agreement”
has the meaning set out above in Background.
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1.4
|
“Effective Date”
means the date of this Agreement.
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1.5
|
“MA Transfer Documents”
all of the documentation necessary or desirable for the transfer to BDSI of the Government Approvals held, as of the Effective Date, in respect of a Licensed Product by Meda.
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1.6
|
“New License”
means the agreement entered into between BDSI and the New Licensee pursuant to Clause 3.
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1.7
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“New Licensee”
means the Third Party which enters into an agreement with Meda and BDSI relating to a grant of all or some of the rights covered by the D&L Agreement prior to its termination.
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1.8
|
“Payments”
means any payment or other consideration paid by or on behalf of the New Licensee or any of its Affiliates to BDSI or any of its Affiliates as consideration for the grant of rights under the
New License (including any payment for the manufacture or supply of any Licensed Product to the extent that such amount exceeds BDSI’s total direct and indirect costs of supply and manufacture), such amounts to include but not be limited to all
signature fees, milestone payments, royalties, and option payments. Where BDSI receives amounts in reimbursement of or advance payment for costs actually incurred by BDSI after the date of the New License with respect to any of its obligations under
the New License, and BDSI has performed such obligations prior to such reimbursement or uses any advanced sums for such purposes, those amounts received shall not be considered as “Payments” hereunder, provided that, where BDSI’s
internal labor costs are being reimbursed or advanced, the exclusion thereof from “Payments” hereunder shall only apply to the extent the FTE rate does not exceed $*** per year. The definition of Payments shall be set out in more detail in
the Termination Agreement, consistent with the foregoing, when the payment provisions under the New License are established.
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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1.9
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“Termination Agreement”
means an agreement containing further details concerning the payments to be made to Meda in furtherance of Clause 3.3 hereof upon termination of the D&L Agreement that is
intended to be executed prior to or simultaneously with the grant of a New License. Any Termination Agreement shall, without limitation, contain provisions setting out in more detail the terms on which Payments shall be shared, a full and final
unconditional release of any claims that Meda may have against BDSI and BDSI may have against Meda in respect of the D&L Agreement, and an indemnity in favour of Meda in respect of any claim or matter arising after the Effective Date in respect
of Licensed Products and/or under the D&L Agreement, as shall be further described in the Termination Agreement.
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1.10
|
“Territory”
has the meaning set out in the D&L Agreement.
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(a)
|
except where this Agreement specifies otherwise, all meetings shall be conducted in and all communications and documents referred to in it or required by it shall be in the English language;
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(b)
|
all references to a particular clause or schedule shall be a reference to that clause or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement;
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(c)
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the headings are inserted for convenience only and shall be ignored in construing this Agreement;
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(d)
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words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa;
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(e)
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words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust association, organisation or other entity, in each case whether or not having separate legal personality;
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(f)
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the words “in particular”, “include”, “included” and “including” are to be construed without limitation to the generality of the preceding words;
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(g)
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reference to any statute or regulation includes any modification or re-enactment of that statute or regulation; and
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(h)
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except as otherwise explicitly stated herein, words and phrases defined in the D&L Agreement shall have the same meaning in this Agreement.
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1.12
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In the event of any inconsistency or conflict between this Agreement and any of the Schedules, this Agreement shall prevail.
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1.13
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Except as otherwise explicitly stated herein, all terms, conditions and provisions of the D&L Agreement shall apply to this Agreement mutatis mutandis. In the event or any discrepancy or contradiction between this
Agreement and the D&L Agreement, this Agreement shall take precedence.
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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2.
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T
RANSFER
OF
THE
M
ARKETING
A
UTHORIZATIONS
;
TERMINATION
OF
D&L A
GREEMENT
A
ND
S
UPPLY
A
GREEMENT
; G
RANT
OF
R
ELATED
R
IGHTS
TO
BDSI
|
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2.1
|
Promptly following the Effective Date, BDSI shall prepare the MA Transfer Documents and submit the same to Meda for approval, such approval not to be unreasonably withheld. On Meda’s approval of such documents,
Meda shall sign the MA Transfer Documents.
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2.2
|
Following signature by Meda, BDSI shall promptly submit the MA Transfer Documents, together with any other documents necessary for the transfer of the Marketing Authorizations to BDSI to the FDA and any other Competent
Authority with which Meda holds a Marketing Authorization (or application therefor) in respect of the Territory.
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2.3
|
Upon such submission for each country in the Territory, Meda shall transfer and assign, and hereby assigns, free and clear of all liens, claims, and encumbrances (except those set forth in this Agreement), the Marketing
Authorization (or application therefor) for such country to BDSI along with the corresponding safety and/or pharmacovigilance database(s) established and maintained until such assignment by Meda.
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2.4
|
On assignment of the Marketing Authorizations (and applications therefor) in the Territory and the corresponding safety and/or pharmacovigilance databases established and maintained until such assignment by Meda to
BDSI, BDSI shall have the right to (i) seek a commercialization partner for Licensed Products; and (ii) seek Governmental Approvals of an amended NDA reflecting any revised formulation or other changes necessary to resolve the
above-referenced issues and interact for that purpose with Competent Authorities or Governmental Authorities
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2.5
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Meda shall until such time that a Reactivation occurs as contemplated by Clause 5.1 below not exercise its rights (i) under Section 3.02, 3.04, 3.06, 3.07, or 7.03 of the D&L Agreement, (ii) with
respect to Governmental Approvals or interactions with Competent Authorities or Governmental Authorities, or (iii) to purchase any products under the Supply Agreement, except as explicitly set forth in this Agreement.
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(a)
|
use, until the earliest of
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(i)
|
the execution of a New License;
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(ii)
|
the termination of this Agreement;
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(iv)
|
the occurrence of 11:59 p.m. Eastern (U.S.) time on February 28, 2016 without Meda’s exercising its right to cause Reactivation,
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Commercially Reasonable Efforts to secure and maintain the Marketing Authorizations in the Territory, to report ADRs to, and interact with,
Competent Authorities or Governmental Authorities in a manner reasonably consistent with the obligations Meda had under Article VI of the D&L Agreement (including Article VI thereof) with respect thereto;
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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(b)
|
have no obligations to supply any products to Meda for use or sale in the Territory under the Supply Agreement, and
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(c)
|
keep Meda indemnified pursuant to Section 10.01 of the D&L Agreement in respect of any Loss that is indemnifiable under such Section 10.01 and Meda may suffer as a consequence of any activities BDSI may
undertake or omissions to act by BDSI in respect of the Marketing Authorizations following the assignment thereof to BDSI.
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2.7
|
Meda shall reasonably cooperate with, and report ADRs and other information to, BDSI to the extent necessary or useful to enable BDSI to comply with the foregoing obligations.
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2.8
|
Following signature of the MA Transfer Documents and submission thereof to the relevant Competent Authority(ies) in a particular jurisdiction in the Territory, Meda shall, except as explicitly provided herein, have no
responsibility with respect to such jurisdiction under (i) the D&L Agreement with respect to the securing or maintenance of any Marketing Authorization therein following the Effective Date or (ii) Section 3.03 or 5.01 of the
D&L Agreement, except in the event of a Reactivation in which the Marketing Authorizations are assigned back to Meda pursuant to Clause 5.1.
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3.1
|
Promptly following the Effective Date, BDSI shall use its Commercially Reasonable Efforts to seek a New Licensee of the rights granted under the D&L Agreement. Prior to entering any material discussions with a
potential New Licensee (including disclosing a copy of the D&L Agreement) BDSI shall enter into a confidentiality agreement with the potential New Licensee limiting the disclosure and use Meda’s Confidential Information on customary and
reasonable terms, provided that (i) BDSI shall be entitled to disclose Meda’s Confidential Information to the extent it relates to the Licensed Products to potential New Licensees under such an agreement and (ii) the use of such
Meda’s Confidential Information to the extent it relates to the Licensed Products shall be permitted only in such negotiations and for purposes of granting and exercising any rights granted under a New License and for no other purpose
whatsoever. The sole purpose of any such negotiations shall be the negotiation of a New License with a New Licensee.
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3.2
|
BDSI shall keep Meda reasonably informed of the status of any negotiations that take place pursuant to Clause 3.1, including providing Meda with the financial terms of any proposed New License and a copy of any term
sheet provided to or by any proposed New Licensee.
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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3.3
|
At any time following execution of a confidentiality agreement as set forth above, BDSI may propose the terms of a New License to the applicable New Licensee. BDSI and Meda shall use Commercially Reasonable good faith
efforts to negotiate and enter into a Termination Agreement prior to or in conjunction with BDSI’s negotiation and execution of a New License, which Termination Agreement shall include customary and reasonable provisions for such an agreement,
and, at the minimum, also contain provisions relating to the following:
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(a)
|
an indemnity in favour of Meda in respect of any claim or matter arising after the effectiveness of the New License resulting from acts or omissions of BDSI or the New Licensee occurring after such effectiveness in
respect of Licensed Products in the Territory;
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(b)
|
revenue sharing provisions such that the New Licensee (or, subject to Meda and BDSI agreeing on suitable terms for the protection of Meda’s interest in such payments, BDSI) pays directly to Meda:
(i)
***
of Payments remaining after the deduction of the CDC Royalty (subject to Clause 3.3(c)) until the total of such payments equals
***
; (ii) for Payments, remaining after deduction of the CDC Royalty (subject to Clause
3.3(c)), received by BDSI or its Affiliates in excess of those necessary to cause payments due under part (i) of this Clause 3.3(b) to equal
***
of such Payments remaining after the deduction of the CDC Royalty (subject to Clause 3.3(c))
until the total of payments under this part (ii) of this Clause 3.3(b) equals
***
in addition to the
***
payable under part (i) of this Clause 3.3(b); and (iii)
***
of Payments, remaining after the deduction of
the CDC Royalty (subject to Clause 3.3(c)), received by BDSI or its Affiliates thereafter;
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(c)
|
for purposes of Clause 3.3(b), under no circumstances shall: (i) any deduction be made in respect of the CDC Royalty from any signature fee or milestone payment payable to BDSI or any Affiliate thereof pursuant to
the New License; (ii) any CDC Royalty deducted in any Quarter from Payments pursuant to Clause 3.3(b) exceed
***
of the CDC Net Sales to which such CDC Royalty corresponds; or (iii) deductions from Payments in respect of the CDC
Royalty extend beyond the date six (6) months following the end of the Royalty Term (as defined in Section 6.6.8 of the CDC Agreement).
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(d)
|
all payment reports shall be copied to Meda and Meda shall have the right to audit on the same terms as BDSI has the rights to audit payments under the New License;
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(e)
|
a provision that if a non-cash Payment is to be made pursuant to a New License then Meda shall receive, at the time such payments are received, the cash equivalent of the fair market value of its share of such non-cash
Payment;
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(f)
|
a provision that the financial terms (both as to amount and/or timing of payments) of the New License may not be amended or varied in a manner that would materially decrease corresponding payments to Meda without
Meda’s prior written consent, such consent not to be unreasonably withheld.
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3.4
|
For the avoidance of doubt BDSI shall not enter into any agreement relating to the licensing of rights to sell or Commercialize Licensed Products in the Territory without Meda’s prior written consent, such consent
not to be unreasonably withheld or delayed, provided (i) always Meda may take into account the ability of the New Licensee to make the payments under the New License and, notwithstanding anything to the contrary, (ii) BDSI shall remain
free to exercise those rights nonexclusively licensed to Meda under Section 3.02 of the D&L Agreement, or license such rights to others, and nothing in this Agreement shall be deemed to supersede or limit BDSI’s reserved rights under
the last sentence of Section 3.02(a) of the D&L Agreement, or BDSI’s ability to license such rights to others, to the extent, in each case, doing so would not conflict with Meda’s rights under the EU Agreement.
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3.5
|
As from the Effective Date, Meda shall not have any obligation to sell, offer for sale, promote, market, or seek Governmental Approval for Licensed Products in the Territory, except to the extent explicitly set forth in
this Agreement or unless and until a Reactivation occurs.
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6
Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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4.1
|
Notwithstanding the termination of the D&L Agreement, and except as explicitly set forth in this Agreement, the terms of Section 8 of the D&L Agreement shall apply to, and bind Meda and BDSI in respect to
confidentiality and Confidential Information (as defined in the D&L Agreement) as though the same were repeated herein, provided that, notwithstanding anything to the contrary, BDSI shall have the right to (i) disclose Meda’s
Confidential Information to the extent it relates to the Licensed Products to any potential New Licensee under reasonable conditions of confidentiality materially as protective as those included in the D&L Agreement; (ii) use Meda’s
Confidential Information to the extent it relates to the Licensed Products as reasonably necessary or useful to perform obligations, and exercise rights, under this Agreement; and (iii) allow any New Licensee to use any such Confidential
Information solely for the purpose of evaluating whether to enter into or negotiating any New License.
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5.1
|
In the event that BDSI has not identified and agreed terms with a New Licensee, and entered into a New License with a New Licensee, on or before 31 December 2015, Meda shall have the right but not the obligation on
*** prior written notice received by BDSI no later than February 28, 2016 (a “Reactivation Notice”) to demand the reassignment of the Marketing Authorizations in the Territory to Meda and to terminate this Agreement. On receipt of
such a notice by BDSI within sixty (60) days of such notice, (i) the provisions of Clauses 2 and 3 shall terminate; (ii) BDSI shall take all reasonable steps to promptly assign the Marketing Authorizations and any other Government
Approvals held by it in respect of Licensed Products to Meda as soon as reasonably possible; and, notwithstanding the sixty (60) day notice period set forth above, (iii) on such assignment, on a country-by-country basis with respect to the
Territory based on such assignments, this Agreement shall terminate and the D&L Agreement and Supply Agreement shall be reinstated in full force and effect, without reflection or effect of any amendment thereto that may have been effected by the
terms of this Agreement during the effectiveness hereof, and continue according to its terms (the occurrence of (i), (ii), and (iii), “Reactivation”).
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5.2
|
To the extent permissible under applicable law, a Party shall have the right to terminate this Agreement immediately upon giving written notice of termination to the other Party upon the occurrence of any insolvency
event in respect of the other Party, including, without limitation, the following events:
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(a)
|
if the other Party files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganisation or for an arrangement or for the appointment of
a receiver or trustee of the Party of all or substantially all of its assets, and such petition shall not be dismissed within sixty (60) days after the filing thereof;
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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(b)
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if the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof;
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(c)
|
if the other Party proposes or becomes a party to any dissolution or liquidation; or
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(d)
|
the other Party makes an assignment for the benefit of its creditors.
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5.3
|
Subject to any earlier termination as set forth above, this Agreement shall terminate on the earlier of (i) the termination of the D&L Agreement or (ii) the occurrence of 11:59 p.m. Eastern (U.S.) time on
February 28, 2016 without Meda’s exercising its right to cause Reactivation or BDSI’s execution of a New License with a Third Party.
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5.4
|
Upon termination of this Agreement pursuant to Section 5.2 or clause (ii) of Section 5.3, and subject to any termination of the D&L Agreement or Supply Agreement and those provisions thereof that may
apply on such termination, BDSI shall promptly take all reasonable steps to assign the Marketing Authorizations and any other Government Approvals held by it in respect of Licensed Products in the Territory to Meda and, on a country-by-country basis
with respect to the Territory based on such assignments, the D&L Agreement and Supply Agreement (and the Parties’ rights and obligations thereunder) shall be reinstated in full force and effect, without reflection or effect of any amendment
thereto that may have been effected by the terms of this Agreement during the effectiveness hereof, and termination of this Agreement shall not prejudice any of the Parties’ rights and remedies which have accrued as of such termination.
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6.
|
R
EPRESENTATIONS
AND
W
ARRANTIES
.
|
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6.1
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Each Party represents and warrants to the other Party that:
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(a)
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As of the Effective Date, it is duly organized and validly existing under the laws of the jurisdiction of its organization and has full power and authority to enter into this Agreement and the transactions contemplated
hereby and to carry out the provisions hereof.
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(b)
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As of the Effective Date, each Party hereby represents and warrants that such Party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder.
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(c)
|
This Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms, except that the enforcement of the
rights and remedies created hereby is subject to bankruptcy, insolvency, reorganization and similar laws of general application affecting the rights and remedies of creditors and that the availability of the remedy of specific performance or of
injunctive relief is subject to the discretion of the
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
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court before which any proceeding therefor may be brought. As of the Effective Date, this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it
is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it.
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6.2
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EXCEPT WITH RESPECT TO CLAIMS OF PATENT INFRINGEMENT, BREACHES OF CONFIDENTIALITY, AND THIRD PARTY DAMAGES COVERED BY THE INDEMNIFICATION PROVIDED UNDER THIS AGREEMENT, THE D&L AGREEMENT, OR THE SUPPLY AGREEMENT, OR
THE GRANT BY BDSI OF ANY NEW LICENSE IN BREACH OF THIS AGREEMENT, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, EXEMPLARY, CONSEQUENTIAL, INDIRECT, OR PUNITIVE DAMAGES (AS SUCH TERMS ARE DEFINED IN BLACK’S LAW
DICTIONARY, SIXTH EDITION) IN CONNECTION WITH THIS AGREEMENT.
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7.1
|
Save as specifically provided herein, nothing in this Agreement shall amend or vary the obligations of the Parties in EU Agreement or the supply agreement executed in conjunction with the EU Agreement.
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7.2
|
The provisions of Section 14 of the D&L Agreement shall apply to this Agreement as though the same were repeated herein save that:
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(b)
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Section 14.09 (Publicity) shall not apply to this Agreement;
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(c)
|
Section 14.14 (Third Party Beneficiary) shall not apply to this Agreement.
|
Each Party shall pay its own costs in connection with the
negotiation and preparation of this Agreement and any New License and/or Termination Agreement.
[Signature page to follow.]
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Confidential Treatment Requested by BioDelivery Sciences International, Inc.
IRS Employer Identification No. 35-208985
Confidential treatment requested with respect to certain portions hereof denoted with “***”
This Agreement has been entered into on the date stated at the beginning of it.
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Signed by:
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/s/ Jörg-Thomas Dierks
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Name:
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Jörg-Thomas Dierks
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Position:
|
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CEO
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By and on behalf of
MEDA AB
|
- and -
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Signed by:
|
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/s/ Mark A. Sirgo
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Position:
|
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President & CEO
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Name:
|
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Mark A. Sirgo
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By and on behalf of
BIODELIVERY SCIENCES INTERNATIONAL, INC.
|
- and -
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Signed by:
|
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/s/ Mark A. Sirgo
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Position:
|
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President & CEO
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Name:
|
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Mark A. Sirgo
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By and on behalf of
ARIUS PHARMACEUTICALS, INC.
|
[Signature page to Assignment and Revenue Sharing Agreement]
Exhibit 99.1
BioDelivery Sciences Acquires North American Marketing Authorizations
for ONSOLIS from Meda
Transaction provides BDSI the opportunity to seek a new partner for ONSOLIS
in the U.S., Canada and Mexico
RALEIGH, NC – January 27, 2015
– BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) announced that it has entered into an
assignment and revenue sharing agreement with Meda AB (Meda) under which Meda will transfer the marketing authorizations for ONSOLIS
®
(fentanyl buccal soluble film, CII) for the United States
and the right to seek marketing authorizations for ONSOLIS in Canada and Mexico, back to BDSI. BDSI originally licensed such rights to Meda in 2007, and ONSOLIS was approved by the U.S. Food and Drug Administration (FDA) and originally commercially
launched in the United States in 2009.
Meda has over the past few years decided to primarily focus on the respiratory area in the U.S., which led to the
present agreement that provides BDSI with an opportunity to seek one or more new commercial partners for ONSOLIS. BDSI will have the right to work directly with the FDA to bring ONSOLIS back to the marketplace in the U.S.
Under the agreement, financial terms have been established that enable Meda to share in the proceeds of any new North American partnership for ONSOLIS that
may be executed by BDSI, and the execution of such a transaction by BDSI will require execution of a definitive termination agreement embodying those royalty-sharing terms and certain other provisions.
“BDSI is looking forward to the opportunity to secure a new commercial partner and in working directly with the FDA to move ONSOLIS back to the U.S.
marketplace,” stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “Although it is unlikely that North American rights to ONSOLIS will be a material asset for BDSI, any revenue we can generate from sales is
additional revenue we do not have today. ONSOLIS in our view is a differentiated transmucosal fentanyl product for treating breakthrough cancer pain, and we look forward to finding a new commercial partner to work along side of us to bring it back
to the U.S. marketplace. Our first action will be to submit the necessary data requested by FDA that we have generated which we believe will answer the formulation questions raised in the past. We will be preparing to make that submission this
quarter. In addition, we are already in discussions with potential commercial partners.”
Meda also holds the European rights to ONSOLIS (where it is
marketed as BREAKYL) via license from BDSI, and BDSI has also previously licensed certain rights to the product in Taiwan, where it is approved and marketed by TTY Biopharm, and in South Korea where it is licensed to Kunwha Pharmaceutical Company.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction
medicine. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA
®
) technology and other drug delivery technologies to develop and commercialize, either on its own or in
partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.
BDSI’s development strategy
focuses on utilization of the FDA’s 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.
BDSI’s particular area of focus is the development and commercialization of products in the areas of pain management and addiction. These are areas where
BDSI believes its drug delivery technologies and products can best be applied to address critical unmet medical needs. BDSI’s marketed products and those in development address serious and debilitating conditions such as breakthrough cancer
pain, chronic pain, painful diabetic neuropathy and opioid dependence.
BDSI’s headquarters is located in Raleigh, North Carolina.
For more information visit
www.bdsi.com
.
BDSI
can now be followed on Facebook (
Facebook.com/BioDeliverySI
) and Twitter (
Twitter.com/BioDeliverySI
)
INDICATION
ONSOLIS (fentanyl buccal soluble film, CII) is indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older,
who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30
mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
The
most serious adverse reactions associated with all opioids, including ONSOLIS, are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. Follow all patients for symptoms of
respiratory depression.
In ONSOLIS trials, the most common adverse reactions (frequency
³
10%) were nausea,
vomiting, dehydration, asthenia, dyspnea, fatigue, constipation, dizziness, and somnolence.
WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION and POTENTIAL FOR ABUSE
ONSOLIS contains fentanyl, an opioid agonist and a Schedule II controlled substance, with abuse liability similar to other opioid analgesics. This should be
considered when prescribing or dispensing ONSOLIS in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances, which include morphine, oxycodone, hydromorphone,
oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
Serious adverse events,
including deaths, in patients treated with other oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution
of ONSOLIS for any other fentanyl product may result in fatal overdose.
ONSOLIS is contraindicated for use in opioid non-tolerant patients
including those using opioids intermittently, on an as needed basis. ONSOLIS is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory
depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products.
ONSOLIS is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and
hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.
When prescribing, do not convert
patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ONSOLIS. Patients beginning treatment with ONSOLIS must begin with titration from the 200 mcg dose [see
Dosage and Administration
]. When
dispensing, do not substitute an ONSOLIS prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products that result in clinically important differences in the
extent of absorption of fentanyl. As a result of these differences, the substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.
ONSOLIS is intended to be used only in the care of opioid-tolerant patients with cancer and only by health care professionals who are knowledgeable of, and
skilled in, the use of Schedule II opioids to treat cancer pain.
Special care must be used when dosing ONSOLIS. If the breakthrough pain episode is not relieved, patients
should wait at least 2 hours before taking another dose [see
Dosage and Administration
].
Patients and their caregivers must be instructed that
ONSOLIS contains a medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. All ONSOLIS films must be kept out of the reach of children [see
Patient
Counseling Information
].
The concomitant use of ONSOLIS with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations
and may cause potentially fatal respiratory depression [see
Drug Interactions
].
Because of the risk for misuse, abuse, addiction, and overdose,
ONSOLIS is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients,
healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program.
[see Warnings and Precautions].
Further information is available at www.TIRFREMSAccess.com or by calling
1-866-822-1483.
For more information, please see the full Prescribing Information and Medication Guide.
Cautionary Note on Forward-Looking Statements
This press
release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the “Company”) related thereto (including, without limitation, at the presentations described herein) contain, or may contain, among
other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may
include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,”
“could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These
statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange
Commission. Actual results (including, without limitation, the anticipated benefits of the Company’s reacquisition of rights to ONSOLIS as described herein) may differ significantly from those set forth in the forward-looking
statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to
publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
BDSI
®
, BEMA
®
and BUNAVAIL
®
are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and
INREACH™ are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS
®
is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark
owned by Meda Pharma GmbH & Co. KG. PAINKYL™ is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners.
Contacts:
Media:
Susan Forman/Laura Radocaj
Dian Griesel Int’l.
212-825-3210
sforman@dgicomm.com
lradocaj@dgicomm.com
Investors:
Brian Korb
Senior Vice President
The Trout Group LLC
(646) 378-2923
bkorb@troutgroup.com
Al Medwar
Vice President, Marketing and Corporate Development
BioDelivery
Sciences International, Inc.
919-582-9050
amedwar@bdsi.com