CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.77
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(b)(2) OF THE SECURITIES
AND EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED IS REQUESTED
AND IS NOTED WITH "[CONFIDENTIAL TREATMENT REQUESTED]." AN UNREDACTED
VERSION OF THIS DOCUMENT HAS BEEN PREVIOUSLY FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION.
EXCLUSIVITY AGREEMENT
THIS AGREEMENT is made the day of 22nd of December 2004
BETWEEN:
(1) PFC Therapeutics, LLC, a limited liability company organized under the
laws of Delaware, USA and having its principal place of business at
0000 Xx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, XX 00000 XXX
(hereinafter referred to as "PFC"), and
(2) XXX Pharma A/S, a company organized under the laws of Denmark and
having its principal place of business at Xxxxxxxxxxxxxx 00, XX-0000
Xxxxxxxx, Xxxxxxx (hereinafter referred to as "XXX")
RECITALS:
(A) The parties have provisionally agreed, subject to due diligence,
contract and the other terms and conditions specified herein, to a
transaction in which PFC will exclusively license to XXX certain rights
to PFC's product Oxygent(R).
(B) This Agreement sets out the framework of the exclusive negotiations
between PFC and XXX in connection with the transaction.
NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:
1. Definitions and Interpretation
1.1. In this Agreement, the following terms shall have the following
meanings unless the context requires otherwise:
"AFFILIATE" means any corporation, firm, partnership, organization or
entity that directly or indirectly controls, is controlled by or is
under common control with such entity. For the purpose of this
definition the term "control" means direct or indirect ownership of at
least fifty one percent (51%) of the outstanding equity voting stock
(or such lesser percentage which is the maximum allowed to be owned by
a foreign corporation in a particular jurisdiction) of an entity.
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"AGENCY" means any governmental authority in the Territory responsible
for granting approvals and clearance for marketing and sale of the
Product.
"AGREEMENT" means this Exclusivity Agreement between PFC and XXX.
"BRIEFING PACKAGE" means the compilation of Data in relation to the
Product and the rational for the continued development and obtaining of
Marketing Authorizations for the Product in the European Union. The
Briefing Package is to be filed to EMEA with the purpose of obtaining a
scientific advice. The Briefing Package must be prepared and filed in
relation to relevant rules and regulations as set out by EMEA for such
procedures.
"CONTROL" or "CONTROLLED" means the possession of/or the ability to
grant a license or sublicense of Data or other intangible rights as
provided for herein without violating the terms of any agreement or
other arrangement with any third party.
"DATA" means information in the possession or Control of either Party
relating to the Product including, without limitation, confidential
know how, technical information, technology and trade secrets relating
to the Product, information relating to the pre-clinical and clinical
testing of the Product, information relating to any Clinical Trials,
information relating to any suspected adverse drug experiences with the
Product and any toxicological, pharmacological or pharmacokinetic
trials relating to the Product.
"EMEA" means the European Medicines Evaluation Agency.
"EXCLUSIVITY FEE" means the fee paid by XXX to PFC in exchange of the
exclusivity period and the rights granted in Clause 2.
"CGMP" means current Good Manufacturing Practice.
"IMPROVEMENTS" means all improvements, modifications or adaptations to
any part of the Data or the Product made or acquired by either Party
during the term of this Agreement.
"KNOW-HOW" includes without limitations all trade xxxx rights, and all
financial, scientific, technical, regulatory, marketing and commercial
know-how and Data concerning the Product.
"MARKETING AUTHORIZATIONS" means any approvals, product and/or
establishment licenses, marketing authorizations or registrations of
any federal, state or local Agency necessary for the commercial
manufacture, use, storage, import, export, transport, marketing or sale
of the Product in any country or regulatory jurisdiction of the
Territory.
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"NET SALES" means the adjusted gross invoice price, the adjusted gross
invoice price being the aggregate sales of XXX and its Affiliates of
the Product to unaffiliated third parties in the Territory (but not
including sales between XXX and its Affiliates) less sales returns and
allowances, including trade, quantity and cash discounts and any other
adjustments, including those granted on account of price adjustments,
billing errors, rejected goods, damaged goods, recalls, returns,
rebates, chargeback rebates, fees, reimbursements or similar payments
granted or given to wholesalers or other distributors (including
retailers), buying groups, health care insurance carriers or other
institutions, freight and insurance charges billed to the customers,
customs or excise duties, sales tax and other taxes (except income
taxes) or duties relating to sales, and any payment in respect of sales
to any governmental or regulatory authority in respect of any federal
or state Medicaid, Medicare or similar program, all as determined in
accordance with generally accepted accounting principles on a basis
consistent with Company LEO's audited financial statements.
"NEW PRESENTATION" means any pharmaceutical product incorporating
perflubron and/or perflubrodec. whether alone or in combination with
other active or inactive ingredients, and any salts or derivatives of
such Product. "Product" shall include Combination Products.
"PARTIES" means PFC and XXX and "Party" means either of them as the
context indicates.
"PATENTS" means patents covering inventions that may be developed by
either Party during the term of the License Agreement and that relate
specifically to the Product, any Improvements or any New Presentations
and any continuations, continuations-in-part, divisional, provisionals
or any substitute applications, any patent issued with respect to any
such patent applications, any reissue, reexamination, renewal or
extension (including any supplementary patent certificate) of any such
patent, and any confirmation patent or patent of addition based on any
such patent, and all foreign counterparts of any of the foregoing.
"PERIOD OF EXCLUSIVITY" The period which will commence on signature of
this Agreement by both Parties and which shall expire no later than
sixty (60) days after receipt of EMEA's written scientific opinion to
the Briefing Package filed.
"PRODUCT" means Oxygent(R) a 60% w/v perflubron emulsion to be used for
the treatment or alleviation of diseases in humans and as further
described in Patents or any Improvements thereof.
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"TERRITORY" means Europe (countries to be defined but will include EU
countries, EU membership applicants, EU associated countries including
NO and CH) and Canada (Other territories outside USA should be
discussed e.g. Middle East, South America where XXX is quite strong).
"TRADE MARKS" means the trade marks, including Oxygent(R), owned by
PFC, including registrations and applications for registration thereof
(and all renewals, modifications and extensions thereof) and used in
connection with the Product in the Territory.
2. Period of Exclusivity and Option
In consideration of the Exclusivity Fee paid by XXX to PFC the
following shall apply:
2.1. Neither PFC nor any of its Affiliates, nor any third parties acting on
behalf of PFC and its Affiliates, will in the Territory during the
Period of Exclusivity:
2.1.1 Discuss the Product with any party other than XXX and its
Affiliates with a view to selling, licensing or otherwise
granting rights to the Product to any other person;
2.1.2 Approach or seek buyers or licensees for the Product other
than XXX and its Affiliates;
2.1.3 Provide a draft contract or confidential information
concerning the Product to anyone other than XXX and its
Affiliates;
2.1.4 Negotiate or agree with anyone other than XXX or its
Affiliates any terms for the purchase or licensing of the
Product; or
2.1.5 Offer or grant rights to the Product or create any liens or
encumbrances over the Product, other than in favour of XXX and
its Affiliates.
2.2. In the Period of Exclusivity PFC will provide to XXX an exclusive
option (even to PFC) (the "Option") to enter into an agreement (the
"License Agreement") with the below main conditions to be included. The
License Agreement must be negotiated and signed by the Parties before
the Briefing Package is filed at EMEA (ref. Clause 4.1). The License
Agreement shall come into force as provided below.
2.2.1 TYPE OF AGREEMENT: XXX will be appointed exclusive licensee
(even to PFC) of the Product in the Territory. The license
will include the exclusive right of XXX to import and/or
manufacture, develop, obtain marketing authorization, store,
distribute, market and sell the Product for the term of the
License Agreement.
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2.2.2 FIELD OF USE: The field of use of the Product is in the
treatment or alleviation of diseases in humans.
2.2.3 DURATION AND TERMINATION OF THE LICENSE AGREEMENT: The License
Agreement shall come into force when and if XXX decides within
the Period of Exclusivity to exercise the Option and, subject
to the Parties' rights of termination to be specified in
the License Agreement, the License Agreement will continue in
force for the later of 10 years after first commercial sales
in either the United Kingdom, Germany or France or expiration
of all valid patents relating to the Product in the Territory.
Upon expiration of the License Agreement XXX will retain an
fully-paid, royalty-free right to continue to import,
manufacture/have manufactured, develop, store, distribute,
market and/or sell the Product in the Territory and an
exclusive, fully-paid, royalty-free right to continue to use
any Data that XXX is using in relation to the import,
manufacture, development, storage, distribution, marketing
and/or sale of the Product at the time of such termination in
the Territory.
2.2.4 DEVELOPMENT: XXX shall be responsible for the clinical
development and registration of the Product in the Territory.
XXX does not guarantee that registration of the Product in the
Territory is obtained. PFC shall provide Product at required
GMP standards in order to enable XXX to conduct the clinical
development program. PFC and XXX shall have the right to use
all Data that exist or will be generated by the other party in
connection with its efforts to obtain the initial registration
of the product in and outside the Territory, respectively. For
additional indications a cost sharing system must be in place
dividing the development costs between the Parties in relation
to the market potential for the additional indication in
question.
2.2.5 PAYMENT TO PFC: If XXX chose to exercise the Option and
thereby brings the License Agreement into force XXX shall pay
to PFC:
2.2.5.1 a non-refundable down-payment of * * * [CONFIDENTIAL
TREATMENT REQUESTED] upon exercise of the Option; and
2.2.5.2 a milestone fee of * * * [CONFIDENTIAL TREATMENT
REQUESTED] at completion of a Phase II clinical study
(or a Phase III clinical study, if a Phase II study
is not required); and
2.2.5.3 a milestone fee of * * * [CONFIDENTIAL TREATMENT
REQUESTED] upon first commercial sale of Product in
the Territory.
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No other down-payments, milestones payments or other
payments, except for the royalty payments mentioned
in Clause 2.2.6, will be paid to PFC in connection
with the License Agreement.
2.2.6 Royalties: XXX shall pay a royalty of * * *[CONFIDENTIAL
TREATMENT REQUESTED] to PFC on annual Net Sales up to * * *,
[CONFIDENTIAL TREATMENT REQUESTED] and a royalty of * * *
[CONFIDENTIAL TREATMENT REQUESTED] to PFC on annual Net Sales
greater than * * * [CONFIDENTIAL TREATMENT REQUESTED]
2.2.7 Trademark: PFC will transfer the ownership of Trade Marks to
XXX in the Territory
2.2.8 Supply of Product: Should XXX elect not to manufacture the
Product, PFC and XXX shall cooperate to secure a contract
manufacturer that can supply the Product at cGMP standards
recognized by the Agency ready for sale by XXX to the end user
in the Territory.
2.2.9 Marketing: XXX, at its expense, shall market and sell Product
in the Territory.
2.2.10 Non-competition: During the term of the License Agreement
neither PFC nor any of its Affiliates are allowed to develop,
manufacture, purchase, advertise, market, promote and/or
distribute any product(s) with indications that directly or
indirectly compete with the indications to be approved for the
product in the Territory.
2.2.11 Warranties: The License Agreement shall include, inter alia,
suitable warranties to XXX and its Affiliates in respect of
the Product, including without limitations PFC's right to the
Product, the Trade Marks and the Know-how and absence of any
pending or threatened claims and proceedings relating to the
Product and the Trade Marks and the Know-how.
3. Exclusivity Fee
3.1. In exchange of the rights set out in Clause 2, XXX will pay PFC * * *
[CONFIDENTIAL TREATMENT REQUESTED]
3.2. The payment mentioned in Section 3.1 will be paid * * * [CONFIDENTIAL
TREATMENT REQUESTED] at signing of this Agreement and * * *
[CONFIDENTIAL TREATMENT REQUESTED] Upon a satisfactory finalisation of
due diligence performed by XXX of PFC, but no later than March 1, 2005.
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3.3. The Exclusivity Fee comprises * * * [CONFIDENTIAL TREATMENT REQUESTED]
of the proposed down payment of the Product as set out in Clause
2.2.5.1 and if the Option is exercised and the License Agreement
thereby comes into force, the Exclusivity Fee will be credited XXX
towards the down payment mentioned in Clause 2.2.5.1.
3.4. Subject to Clause 3.5, if XXX chooses not to exercise its Option, the
Exclusivity Fee will be regarded as payment in full for the Period of
Exclusivity.
3.5. If PFC acts in breach of this Agreement and as a result the Option is
not exercised and/or the License Agreement is not effective, PFC shall
promptly refund the Exclusivity Fee on demand by XXX and pay all
reasonable and documented costs and expenses properly incurred by XXX
in connection with its efforts to fulfil its obligations in relation to
this Agreement.
4. Period of Exclusivity
4.1. Upon commencement of the Period of Exclusivity:
4.1.1 With the assistance of PFC XXX shall prepare and submit a
Briefing Package containing relevant background information
and a plan for the development and registration of the Product
in Europe to EMEA in order to solicit a written scientific
opinion of the development plan for Europe. If agreed by EMEA
the Parties will conduct a face to face meeting with EMEA.
4.1.2 Any costs and fees in relation to achieving a scientific
opinion from EMEA will be paid by XXX.
4.1.3 XXX shall prepare a draft License Agreement as described in
Clause 2.2 for PFC's review and the Parties shall meet as soon
as mutually convenient to negotiate the final terms and
conditions of the License Agreement. The License Agreement
must be signed by the parties no later than the date of filing
of the Briefing Package to EMEA.
4.1.4 PFC and its Affiliates, representatives and agents shall
allocate the necessary and adequate resources to fulfil its
obligations under this Agreement and shall assist and
cooperate with XXX and its Affiliates and representatives and
agents throughout the Period of Exclusivity and give such
access to Data, records and files as XXX may reasonably
require carrying out its duties under this Agreement.
4.2. Throughout the Period of Exclusivity, PFC and XXX will negotiate with
each other in good faith, and PFC will deal expeditiously and
reasonably with any enquiries about the Product raised by XXX and its
Affiliates.
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4.3. If during the Period of Exclusivity XXX decides not to license the
Product, it will give prompt written notice to that effect to PFC; the
Period of Exclusivity shall thereupon cease and this Agreement will
then be automatically terminated without further notice.
4.4. If the Parties have not signed the License Agreement before the jointly
prepared Briefing Package is ready for filing to EMEA, the filing of
the Briefing Package must be postponed until agreement between the
parties is achieved.
4.5. Except as otherwise stated herein, each Party shall bear its own cost
and expenses incurred in connection with the transactions contemplated
by this Agreement and the License Agreement.
5. Warranties and Covenants
5.1. PFC hereby represents and warrants to XXX and its Affiliates as
follows:
5.1.1 This Agreement has been executed and delivered by a duly
authorized signatory of PFC;
5.1.2 There is no action, claim or proceeding nor, to the best
knowledge of PFC, any threat of an action, claim or
proceedings that would materially affect the Product, the
rights granted to XXX herein or the rights proposed to be
licensed to XXX;
5.1.3 PFC is not aware of any defect in its title to the Product or
to the Trade Marks or of any misrepresentation made by it or
its advisors to XXX in connection with the subject matter of
this Agreement;
5.1.4 PFC and its Affiliates will not be in breach of any
contractual obligation with any third party by reason of
entering this Agreement or the License Agreement; and
5.1.5 PFC shall promptly disclose to XXX any matter occurring during
the Period of Exclusivity that is inconsistent with any of the
above warranties forthwith upon becoming aware of it.
5.2. XXX hereby represents and warrants to PFC that this Agreement has been
executed and delivered by a duly authorized signatory of XXX.
5.3. PFC covenants with XXX and its Affiliates that during the Period of
Exclusivity PCF shall:
5.3.1 Not knowingly relinquish or prejudice its rights relating to
the Product, the Trade Marks or the Know-how;
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5.3.2 Promptly upon becoming aware of the same, notify XXX of any
event, action, claim or proceeding that would materially
affect the Product or the rights granted to XXX herein or in
the License Agreement;
5.3.3 Promptly provide XXX with copies of all correspondence or
notices that would have a material effect on the Product or
the License Agreement, including without limitations reports
of any adverse events concerning the Product.
6. Confidentiality
6.1. Except to the extent expressly authorized by this Agreement or
otherwise agreed in writing, the Parties agree that, during the term of
this Agreement and for three (3) years thereafter, the receiving Party
shall keep completely confidential and shall not publish or otherwise
disclose or use for any purpose other than as provided for it by this
Agreement any Data or other information and materials furnished to it
by the other Party pursuant to this Agreement (collectively
"Confidential Information") or developed and/or generated under or in
connection with this Agreement, except to the extent that it can be
established by the receiving Party that such Confidential Information:
6.1.1 was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by
the other Party;
6.1.2 was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving
Party;
6.1.3 became generally available to the public or otherwise part of
the public domain after its disclosure and other than through
any act or omission of the receiving Party in breach of this
Agreement; or
6.1.4 was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a third party who had no
obligation to the disclosing Party not to disclose such
information to others.
6.2. Each Party may disclose Confidential Information hereunder to the
extent that such disclosure is reasonably necessary for exercising its
rights and carrying out its obligations under this Agreement and in
complying with applicable governmental regulations or conducting
Clinical Trials as authorized under this Agreement, provided that if a
Party is required by law or regulation to make any such disclosure of
the other Party's Confidential Information it will, except where
impracticable for necessary disclosures (for example, in the event of
medical emergency), give reasonable advance notice to the other Party
of such disclosure requirement and, except to the extent inappropriate
in the case of patent applications, will use its reasonable efforts to
secure confidential treatment of such Confidential Information required
to be disclosed.
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6.3. Each Party shall assure that its respective employees, officers,
directors and other representatives, and any third party to any
Clinical Trial agreements are bound by a confidentiality obligation in
substantially the same terms as provided for under this Clause 6.
6.4. This Section 6 shall survive termination or expiration of this
agreement for a period of three (3) years.
7. Miscellaneous
7.1. Within four (4) business days of signing this Agreement, Alliance
Pharmaceutical Corp. will issue a press release acceptable to XXX
announcing PFC's signing of this Agreement with XXX.
7.2. This Agreement shall not give rise to any legally binding obligation on
the Parties to complete the License Agreement. Any legal commitment
with regard to the License Agreement shall only arise pursuant to a
definitive License Agreement and the related legal documents including,
but not limited to, a supply agreement as set out in clause 2.2.8,
executed by both Parties and/or their Affiliates.
7.3. Clause 3.5, 6 and 7.7 of this Agreement shall survive the Period of
Exclusivity.
7.4. Any notice or communications required or permitted hereunder shall be
in writing and shall be deemed sufficiently given only if delivered in
person or sent by facsimile or by first class post or by a recognized
courier service, postage or other charges prepaid, addressed to the
recipient Party at the address set out at the top of this Agreement, or
to such other address as the addressee may have specified in a notice
duly given to sender as provided herein. Such notice or communication
will be deemed to have been given as of the date so delivered, faxed,
mailed or sent by courier.
7.5. This Agreement shall inure to the benefit of and be binding upon the
parties hereto and their respective successors and permitted assigns.
The rights and obligations of each party hereto may not be assigned
without the written consent of the other.
7.6. This Agreement contains the entire understanding between PFC and XXX
relating to the subject matter hereof and supersedes all prior and
contemporaneous agreements and understandings, whether oral or written,
relating to the subject matter hereof. This Agreement shall not be
amended, modified or supplemented except by writing duly executed by an
authorized officer of each Party.
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7.7. In the event of any controversy or claim arising out of or relating to
any provision of this Agreement or the breach or invalidity hereof, the
parties shall try to settle the problem amicably between themselves.
Should they fail to agree, the matter in dispute shall be settled in
accordance with the laws of United Kingdom and in an English court.
This clause shall remain in effect even if this Agreement is
terminated.
IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be
duly executed by their authorized officers on the day and year first
above written.
XXX Pharma A/S PFC Therapeutics, LLC
By: /s/ XXXX XXXXXXXXX By: /s/ XXXXX X. XXXX
Name: Xxxx Xxxxxxxxx Name: Xxxxx X. Xxxx
Title: Exec VP R&D Title: Manager
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