Exhibit 10.3
VICURON PHARMACEUTICALS
INC.
AND
OSCIENT PHARMACEUTICALS
CORPORATION
ASSIGNMENT AND TERMINATION
AGREEMENT
THIS ASSIGNMENT AND TERMINATION
AGREEMENT (the “Agreement”) is made effective as of the
3 RD day of February, 2006 (the
“Effective Date”) by and between Oscient
Pharmaceuticals Corporation (formerly known as Genome Therapeutics
Corporation), a Massachusetts corporation having its principal
place of business at 1000 Winter Street, Suite 2200, Waltham, MA
02451, USA (“Oscient”) and Vicuron Pharmaceuticals
Inc., a Delaware corporation with its principal place of business
at 455 South Gulph Road, Suite 305, King of Prussia, PA 19406, USA
(for itself and as successor-in-interest to Biosearch Italia,
“Vicuron”). Oscient and Vicuron are sometimes referred
to herein individually as a “Party” and collectively as
the “Parties.”
RECITALS
A. Vicuron is a biopharmaceutical company that
discovers, develops and manufactures medicines for hospital-based
infectious diseases. On September 14, 2005, Pfizer Inc.
acquired Vicuron (formerly known as Versicor Inc.), the successor
to Biosearch Italia (“Biosearch”), an Italian
pharmaceutical company. Biosearch discovered and partly developed a
proprietary compound named Ramoplanin. Vicuron is now a
wholly-owned subsidiary of Pfizer.
B . Oscient is a biopharmaceutical company
committed to the clinical development and commercialization of
novel therapeutics to address unmet medical needs and is interested
in completing the development of Ramoplanin and commercializing
Ramoplanin.
C. On October 8, 2001 Biosearch entered into a
License and Supply Agreement with Oscient to permit the latter to
develop and commercialize in the United States and Canada
(including the territories and possessions of each such country)
Ramoplanin for the treatment or prevention of any human disease
(together with Amendment No. 1 dated as of August 8, 2002
and the letter agreement dated as of October 22, 2002, the
“License and Supply Agreement”).
D. Oscient and Vicuron (who has assumed the rights
and obligations of Biosearch under the License and Supply Agreement
by virtue of the merger of Versicor and Biosearch) wish to
terminate the License and Supply Agreement and simultaneously enter
into a new agreement by which, among other actions, Vicuron will
assign to Oscient certain property related to Ramoplanin on the
terms and conditions set forth in this Agreement.
ARTICLE 1
DEFINITIONS
The following terms shall have the
following meanings as used in this Agreement:
1.1
“Affiliate” means an entity that, directly or indirectly,
through one or more intermediaries, controls, is controlled by or
is under common control with Vicuron or Oscient, as the case may
be.
1.2 “Assigned
Property” shall
have the meaning set forth in Section 3.1.
1.3 “Bulk
Compound” means
the bulk form of the Compound meeting the Specifications and used
to manufacture Product.
1.4
“Commercialization” shall mean all activities undertaken by Oscient
or its designees relating to the manufacture and sale of Product in
the Territory, including advertising, education, marketing,
distribution and post-approval product support clinical studies
conducted after Regulatory Approval of a Product for a particular
indication.
1.5
“Compound” means the compound known as Ramoplanin, as
described in *****.
1.6
“Control” means possession of the ability to grant rights
as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
1.7 “Derivative Patents”
shall mean the patents and patent applications listed on
Schedule 1.7 and all related patent applications, including
divisions, reissues, continuations, continuations-in-part,
re-examination applications and extensions thereof and all foreign
counterpart patents and patent applications.
1.8
“Development” means all activities relating to obtaining
Regulatory Approval of a Product, Product delivery systems and new
indications thereof and all activities relating to developing the
ability to manufacture the same.
1.9 “Excluded
Trademarks” means those trademarks listed on Schedule
1.9 .
1.10 “FDA” means the United
States Food and Drug Administration or any successor agency
thereto.
1.11 “Former
Partner” shall
mean that certain company with which Biosearch entered into a
License and Supply Agreement dated May 8, 1998 and an
amendment thereto effective as of June 1, 2001.
1.12 “Global
Trademarks” means all trademarks except for Excluded
Trademarks, including without limitation any registrations and
common law rights associated therewith, and any goodwill associated
with any of the foregoing, used for or in connection with Products,
Bulk Compound, and Compound.
1.13 “Global
Tradenames” means all tradenames, including without
limitation any registrations and common law rights associated
therewith, and any goodwill associated with any of the foregoing,
used for or in connection with Products, Bulk Compound, and
Compound.
1.14 “IND” (or
“Investigational New Drug Application”)
means an application as defined in
the United States Food, Drug and Cosmetic Act and applicable
regulations promulgated thereunder to the FDA or the equivalent
application to the equivalent agency in jurisdictions outside the
United States, the filing of which is necessary to commence
clinical testing of Products in humans.
1.15
“Information” means any and all techniques and data,
inventions, discoveries, practices, processes, methods, knowledge,
results, trade secrets or other know-how, skill, experience, test
data including pharmacological, toxicological, non-clinical and
clinical data, medical literature compilations, and analytical and
quality control data or descriptions.
1.16 “Joint Patent” means
any inventions made jointly by personnel of Vicuron (or its
Affiliates) and Oscient under the License and Supply
Agreement.
* Confidential information has been omitted and
filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request.
2
1.17 “Materials” means any
and all (i) compounds, compositions of matter, strains, cell
lines and banks, assays and biological materials, including *****,
and other related proprietary strains, and (ii) all other
documents, files, diagrams, specifications, designs, schematics,
reports, records, laboratory notebooks, manufacturing and other
materials, packaging, commercial and market information,
prototypes, test devices, models or simulations, or other written,
graphic, biologic or other tangible material in any
medium.
1.18
“NDA” means an application as defined in the United
States Food, Drug and Cosmetic Act and applicable regulations
promulgated thereunder to the FDA, or the equivalent application to
the equivalent agency in jurisdictions outside the United States,
the filing of which is necessary to commence the commercial sale of
Products.
1.19 “Net
Sales” means
the gross sales with respect to a Product in final dosage form by
Oscient, its Affiliates or its licensees to a Third Party end user,
based upon the approval received from the FDA or RHA, less
(i) discounts, including cash discounts, and/or rebates
(including government-mandated rebates), retroactive price
reductions or allowances actually allowed or granted from the
billed amount, (ii) credits or allowances actually granted
upon claims, rejections or returns of such Products, including
recalls, (iii) freight, postage, shipping and insurance
charges paid for delivery of Product, to the extent both billed and
Oscient bears the cost of freight and insurance for a Product, and
(iv) taxes (except income taxes), duties or other governmental
charges levied on or measured by the billing amount when included
in billing, as adjusted for rebates and refunds. Net Sales shall be
determined from books and records maintained in accordance with
generally acceptable accounting principles in the United States,
consistently applied.
In the event Vicuron is receiving
royalties under this Agreement from any Product sold in the form of
a combination product containing one or more active ingredients in
addition to the Compound, Net Sales for such combination product
will be calculated by multiplying actual Net Sales by the fraction
A/(A+B) where A is the fair market value of the portion of the
combination product that contains the Compound and B is the fair
market value of the other active ingredients included in such
combination product, as determined by market prices of such
portions if separately priced and sold. If, on a country-by-country
basis, the other active ingredient or ingredients in the
combination are not sold separately in that country, Net Sales
shall be calculated by multiplying actual Net Sales of such
combination product by the fraction A/C where A is the fair market
value of the Product if sold separately, and C is the fair market
value of the combination product. If, on a country by country
basis, neither the Product nor the other active component or
components of the combination product is sold separately in said
country, Net Sales shall be determined by mutual agreement of both
the parties acting in good faith. As used herein, the term
“active ingredient” does not include ingredients the
primary effect of which is the enhancement of drug delivery, even
if such ingredients have pharmacological activity.
1.20 “New
Territory” means all countries and territories worldwide
other than those included in the Original Territory.
1.21 “Original
Territory” means the United States and Canada and the
territories and possessions of each of the foregoing
countries.
1.22
“Patent” means (i) valid and enforceable patents,
re-examinations, reissues, renewals, extensions, term restorations
and foreign counterparts thereof, and (ii) pending (at any
time during the term of this Agreement) patent applications and
foreign counterparts thereof.
1.23 “Patent
Rights” means
any and all (a) U.S. or foreign patents, (b) U.S. or
foreign patent applications, including, without limitation, all
provisional applications, substitutions, continuations,
continuations-in-part, divisions, renewals, and all patents granted
thereon, (c) all patents-of-addition, reissues, reexaminations
and extensions or restorations by existing or future extension or
restoration mechanisms, including, without limitation,
supplementary protection certificates or the equivalent of any of
the foregoing, (d) any other form of government-issued right
substantially equivalent to any of the foregoing, and (e) any
and all foreign counterparts of the foregoing.
* Confidential information has been omitted and
filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request.
3
1.24 “
Product” means any product including or incorporating any
formulation of the Compound.
1.25 “Regulatory
Approval” means any and all approvals (including pricing
and reimbursement approvals, if appropriate), product and/or
establishment licenses, registrations, authorizations, or
designations of any federal, state or local regulatory agency,
department, bureau or other governmental entity, necessary or used
for the Development, manufacture, use, or storage of Products in a
regulatory jurisdiction, including, without limitation, INDs, NDAs,
any fast track or orphan drug designation or other similar
designations, and data or market exclusivity
.
1.26 “Regulatory Filing”
means any and all filings, submissions or communications with or to
the FDA or RHA which relate to the Product or Regulatory Approvals,
whether or not obtained, and any other documents related thereto,
including without limitation any filings, submissions,
communications or documents associated with an IND, NDA or fast
track or orphan drug designation.
1.27 “ RHA
” means any
relevant government health authority (or successor agency thereto)
in any country, other than the FDA, whose Regulatory Approval is
necessary to market and sell the Product in the relevant country of
the Territory.
1.28 “ Royalty
” shall have the
meaning set forth in Section 7.1.
1.29 “
Specifications ” means the current specifications for Bulk
Compound as attached to this Agreement as Exhibit I.
1.30 “ Territory
” means all
countries and territories worldwide.
1.31 “Third
Party ” means any entity other than Vicuron or Oscient
or their Affiliates.
1.32 “Vicuron Know-how
and Materials” means any and all Information and Materials
owned or Controlled by Vicuron that is directly related to or is
used solely in connection with the Bulk Compound, Compound, or
Products, or the manufacturing, Development or Commercialization
thereof. Without limiting the foregoing, Vicuron Know-how and
Materials does not include Information and Materials that is
developed or acquired by Vicuron or its Affiliates if such
Information and Materials have only an incidental, and not direct,
relationship to any Bulk Compound, Compound or Products.
1.33 “ Vicuron Licensed
Know-how and Materials” means any and all Information and Materials
owned or Controlled by Vicuron that is not Vicuron Know-how and
Materials and that is necessary, required, or used in connection
with the manufacturing, Development and Commercialization of Bulk
Compound, Compound, and Products.
1.34 “Vicuron
Patents” means
the patents listed on Schedule 3.1(a) hereto.
1.35 “Vicuron Regulatory
Approvals” means those Regulatory Approvals owned or
Controlled by Vicuron.
4
ARTICLE 2
TERMINATION
2.1 Termination of the License
and Supply Agreement; New Agreement. The Parties agree that this Agreement shall
supercede the License and Supply Agreement, which shall be and
hereby is terminated as of the Effective Date, and, notwithstanding
any provisions of the License and Supply Agreement to the contrary,
no rights, obligations or liabilities of the Parties under the
License and Supply Agreement shall survive this termination except
for the rights, obligations and liabilities of both Parties under
Sections 12.2 (Representations), 13 (“Indemnification”)
and 14 (“Miscellaneous”) and Vicuron’s
obligations or liabilities under Section 9
(“Confidentiality”) thereof.
ARTICLE 3
ASSIGNMENT AND
LICENSE
3.1 Assignment of Property. Vicuron hereby
sells, transfers, and assigns to Oscient the following rights, free
and clear of any liens, charges, claims, encumbrances or
restrictions whatsoever (“Assigned
Property”):
(a) all of Vicuron’s rights, title, and
interests in and to the Vicuron Patents listed on Schedule
3.1(a) to this Agreement, and all Patent Rights issuing or
arising therefrom, to the full end of their terms (“Assigned
Patents”);
(b) all of Vicuron’s rights, title and
interests in and to the Vicuron Know-how and Materials
(“Assigned Know-how”);
(c) all of Vicuron’s rights, title and
interests in and to the Global Trademarks and Global Tradenames,
including those listed on Schedule 3.1(c) to this
Agreement;
(d) all of Vicuron’s rights, title and
interests in and to Regulatory Filings and Vicuron Regulatory
Approvals;
(e) any other rights, title and interests of Vicuron
that are necessary or used in the Development, Commercialization,
and manufacture of the Bulk Compound, Compound, and Products;
and
(f) any and all causes of action, claims, demands or
other rights, occasioned from or because of any and all past and
future infringement, misappropriation, dilution or any other
violation of rights of any of the Assigned Property, including all
rights to recover damages, profits and injunctive relief for
infringement of any of the Assigned Property.
3.2 Further
Assurances. Vicuron shall
execute and sign such further assignments, including the patent and
trademark assignment forms provided in Exhibits II and III,
respectively, instruments, applications and documents, and do or
cause to be done such other acts and things, as may reasonably be
required by Oscient to effectively vest in Oscient all of the
Assigned Property, except that Vicuron shall not be required to
file any patent or trademark assignments with any governmental
authorities or agencies anywhere in the Territory.
3.3 No Assumption of Liabilities
or Obligations.
(a) Except as expressly set forth in this Agreement,
Oscient is not assuming and shall not be liable for any contractual
obligations of Vicuron or its Affiliates or any other liabilities
or obligations of Vicuron or its Affiliates of any nature, fixed or
contingent, disclosed or undisclosed, to the extent that such
liabilities or obligations arose, or related to an act, omission or
breach occurring, prior to the Effective Date, which such
liabilities or obligations pertain to the Assigned Property or
arise from the consummation of the transactions contemplated
hereunder, all of which liabilities and obligations shall remain
the sole responsibility of Vicuron.
5
(b) Except as expressly set forth in this Agreement,
Vicuron is not assuming and shall not be liable for any contractual
obligations of Oscient or its Affiliates or any other liabilities
or obligations of Oscient or its Affiliates of any nature, fixed or
contingent, disclosed or undisclosed, to the extent that such
liabilities or obligations arose, or related to an act, omission or
breach occurring, on or following the Effective Date, which such
liabilities or obligations pertain to the Assigned Property or
arise from the consummation of the transactions contemplated
hereunder, all of which liabilities and obligations shall be sole
responsibility of Oscient.
3.4 License
. Vicuron hereby grants to Oscient a
worldwide, irrevocable, royalty-free, non-exclusive license, with
the right to sublicense under the Vicuron Licensed Know-how and
Materials, to manufacture, Develop and Commercialize Bulk Compound,
Compound, and Products; provided , however , that in
the event that Vicuron is required to pay any fees associated with
Oscient’s use of any Vicuron Licensed Know-how and Materials
on or following the Effective Date, Vicuron will notify Oscient of
such fees and if Oscient agrees in writing to obtain such license,
Vicuron and Oscient will negotiate in good faith to determine the
amount of royalty or other payment due to Vicuron in consideration
for the license granted pursuant to this
Section 3.4.
3.5 Right of Negotiation for
Derivative Patents. The
Parties further agree that, if Vicuron has not licensed all or a
portion of its rights under a Derivative Patent to a Third Party,
or assigned or otherwise transferred a Derivative Patent to a Third
Party on or before the ***** of the Effective Date (“Option
Date”), Oscient may request within a ***** day period
following the Option Date to discuss with Vicuron the terms upon
which Oscient will accept the assignment of such Derivative Patent.
The Parties shall meet after such request and negotiate in good
faith the potential terms of an agreement on such terms. If the
Parties do not enter into such an agreement within ***** days after
Oscient so requests to negotiate such opportunity with Vicuron
(“Negotiation Period”), then Vicuron shall thereafter
be free to offer such opportunity to a Third Party with respect to
such Derivative Patent; provided, however, that Vicuron shall not
enter into any agreement with any Third Party with respect to such
Derivative Patent on terms that are more favorable to such Third
Party than those last offered by Vicuron to Oscient during the
Negotiation Period. In the event that Vicuron does not enter into
any agreement with any Third Party with respect to such Derivative
Patent within ***** days after the Negotiation Period, Vicuron and
Oscient shall enter into an agreement on terms last offered by
Oscient during the Negotiation Period. Vicuron agrees to give
Oscient prompt notice in writing if Vicuron licenses or assigns all
or a portion of its rights under any Derivative Patent to a Third
Party.
ARTICLE 4
EXECUTION FEE; MILESTONE
PAYMENTS
4.1 Execution Fee.
As partial payment for the Assigned
Property granted by Vicuron pursuant to Article 3 of this
Agreement, Oscient shall pay to Vicuron, within two
(2) business days after the Effective Date, ***** Dollars
(U.S.$ *****), cash by wire transfer (same value date).
4.2 Milestone Payments for
Original Territory. Oscient or its licensee shall make the
following milestone payments to Vicuron within ten
(10) business days after the first achievement of each of the
following milestones with respect to the Product in the Original
Territory:
|
|
(i)
|
***** Dollars
(U.S. $*****) payable upon filing of the U.S. NDA with the
FDA.
|
|
|
(ii)
|
***** Dollars
(U.S. $*****) payable upon approval of the U.S. NDA by the
FDA.
|
* Confidential information has been omitted and
filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request.
6
4.3 Milestone Payments for New
Territory. Oscient or its
licensee shall make the following milestone payments to Vicuron
within ten (10) business days after the first achievement of
each of the following milestones with respect to the Product in the
New Territory:
|
|
(i)
|
***** Dollars
(U.S. $*****) payable upon filing of an NDA with the European
Agency for the Evaluation of Medicinal Products
(“EMEA”).
|
|
|
(ii)
|
***** Dollars
(U.S. $*****) payable upon receipt of Regulatory Approval of an NDA
from the EMEA.
|
|
|
(iii)
|
***** Dollars
(U.S. $*****) payable upon filing of an NDA in Japan.
|
|
|
(iv)
|
***** Dollars
(U.S. $*****) payable upon receipt of Regulatory Approval of an NDA
in Japan.
|
Any grant by Oscient of a license to
a Third Party shall not affect Vicuron’s right to receive
milestone payments as provided in Sections 4.2 and 4.3. Oscient
shall remain responsible for the payments due to Vicuron pursuant
to Sections 4.2 and 4.3 in the event it grants any such license.
The payment amounts are nonrefundable and noncreditable.
ARTICLE 5
TECHNOLOGY
TRANSFER
5.1 Transfer of Vicuron Know-how
and Materials.
(a) Within thirty (30) days of the Effective
Date, Vicuron shall deliver and transfer to Oscient, or
Oscient’s designee, all Vicuron Know-how and Materials,
Vicuron Licensed Know-how and Materials, and Regulatory Filings to
a location designated by Oscient and in accordance with
commercially reasonable procedures for a transfer of this type.
Vicuron will provide Oscient with all reasonable assistance
required to transfer the Vicuron Know-how and Materials, Vicuron
Licensed Know-how and Materials, Regulatory Filings and Vicuron
Regulatory Approvals, and the benefit thereof, to Oscient or
Oscient’s designee. Without limiting the generality of the
foregoing, (a) Vicuron shall provide Oscient or its designee
with all Information and Materials in its possession necessary to
enable it to manufacture the Bulk Compound and Product, and
(b) if visits with personnel of Vicuron and its Affiliates are
reasonably requested by Oscient for purposes of transferring the
Vicuron Know-how and Materials, Vicuron Licensed Know-how and
Materials, Regulatory Filings and Vicuron Regulatory Approvals to
Oscient or its designee, or for purposes of Oscient’s
acquiring expertise on the practical application and use of the
Vicuron Know-how and Materials, Vicuron Licensed Know-how and
Materials, Regulatory Filings or Vicuron Regulatory Approvals or of
assisting Oscient or its designee on issues arising during such
transfer and transition, then, on a reasonable schedule to be
agreed upon by the Parties, qualified personnel from each Party
with appropriate technical or regulatory expertise who are familiar
with all aspects of the Vicuron Know-how and Materials, Vicuron
Licensed Know-how and Materials, Regulatory Filings and Vicuron
Regulatory Approvals shall meet at such facilities or locations as
may be mutually agreed upon, and shall participate in telephone
conference calls so that the personnel from Vicuron can transfer
knowledge to Oscient personnel about manufacture of the Products.
The Parties now anticipate that these in-person meetings shall
occur at mutually agreed locations and that telephone conference
calls shall occur regularly for a period of at least ***** months
from the Effective Date, it being agreed that there shall be no
more than ***** days of in-person meetings during such *****-month
period unless the Parties agree to additional meetings.
Notwithstanding the foregoing, until Oscient or its designee *****,
Vicuron shall make available to Oscient Vicuron’s
then-current employees or then-current consultants who have
expertise or knowledge relevant to the manufacture of Bulk Compound
on a reasonable schedule to be agreed upon by the Parties. The
transfer of Vicuron Know-how and Materials and Vicuron Licensed
Know-how and Materials to Oscient shall be complete only upon
Vicuron’s
* Confidential information has been omitted and
filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request.
7
satisfaction of the foregoing requirements.
Vicuron and its Affiliates agree to cooperate with Oscient and
applicable regulatory authorities to the extent reasonably
necessary to effect the successful transfer of Regulatory Filings
and Vicuron Regulatory Approvals.
(b) As of the Effective Date, Vicuron has designated
Jeffrey Meckler as its primary contact person and Oscient has
designated Diane McGuire as its primary contact person. The primary
contact persons shall be responsible for oversight of the
interactions and activities described in Section 5.1(a) and
shall attempt to resolve any questions that arise during the course
of such transfer.
ARTICLE 6
BULK COMPOUND
6.1 Transfer of Bulk
Compound. Vicuron agrees
to provide Oscient with any or all of the Bulk Compound for no
additional consideration. Vicuron estimates there is approximately
***** kg of Bulk Compound.
ARTICLE 7
ROYALTIES; PAYMENT PROCEDURES AND
RECORDS
7.1 Royalties.
Oscient shall pay to Vicuron a
royalty equal to (a) ***** percent (*****%) of Net Sales in
the Original Territory and (b) ***** percent (*****%) of Net
Sales in the New Territory (collectively
“Royalty”).
7.2 Sales by
Licensees. If Oscient
grants a license under the rights granted to it pursuant to Article
3, then such license shall include an obligation for the licensee
to account for and report to Oscient its Net Sales of such Products
on the same basis as if such sales were Net Sales by Oscient, and
Oscient shall pay Royalties to Vicuron on such sales as if the Net
Sales of the licensee were Net Sales of Oscient.
7.3 Royalty
Reports.
(a) Oscient will deliver to Vicuron a report showing
in detail its calculation of the Net Sales and quantities of any
Products sold by Oscient during a given calendar quarter within
***** days following the end of such quarter for which Royalty
payments are due from Oscient. Oscient shall pay the Royalty due on
Net Sales during the calendar quarter covered by a given report
under this Section 7.3 simultaneously with the delivery of
such report to Vicuron.
(b) Oscient will deliver to Vicuron a report showing
in detail its calculation of the Net Sales and quantities of any
Products sold by Oscient’s licensees during a given calendar
quarter to Vicuron within ***** business days following
Oscient’s receipt of such report by its licensees. Oscient
shall pay the amounts due to Vicuron on Net Sales by
Oscient’s licensees pursuant to Section 7.2
simultaneously with the delivery of such report to Vicuron. Oscient
shall use reasonable efforts to have licensees provide such report
in a timely fashion after the end of each calendar quarter and each
calendar year.
7.4 Exchange Rate; Manner and
Place of Payment. All
amounts paid to Vicuron hereunder shall be paid in United States
currency. Net Sales shall be accounted for on a monthly basis in
U.S. Dollars at the spot rate of exchange published by the Board of
Governors of the Federal Reserve System in Statistical Release H.10
(http://www.federalreserve.gov/releases/H10) for each month on the
last banking day of such month. All payments due to Vicuron under
this