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Exhibit
10.1
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HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
ASSET PURCHASE
AGREEMENT
THIS ASSET PURCHASE AGREEMENT
(this “ Agreement ”), dated as of August 15,
2007 (the “ Agreement Date ”), is made by and
between CELL THERAPEUTICS, INC., a Washington corporation (“
Buyer ”), and BIOGEN IDEC INC., a Delaware corporation
(“ Seller ”).
WHEREAS, Seller and certain
of Seller’s Affiliates (as defined below) manufacture,
market, sell and distribute in the United States the Product (as
defined below);
WHEREAS, Seller desires to
sell to Buyer, and Buyer desires to purchase from Seller, certain
Purchased Assets (as defined below) related to the Product in the
United States, all upon the terms and subject to the conditions set
forth in this Agreement; and
WHEREAS, in connection with
the purchase and sale of the Purchased Assets, Buyer and Seller
desire to enter into certain arrangements with respect to the
Purchased Assets in the United States as expressly contemplated by
this Agreement.
NOW, THEREFORE, in
consideration of the premises and mutual covenants contained herein
and for other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, Buyer and Seller agree
as follows:
ARTICLE I
DEFINITIONS
Section 1.1
Definitions . As used in this Agreement, the following terms
shall have the meanings ascribed to them below:
“ Action ”
means any claim, dispute, action (including any action seeking
injunctive or other equitable relief), arbitration, mediation,
litigation, proceeding, suit or governmental investigation and any
appeal therefrom.
“ Affiliate
” means, with respect to any Person, any other Person that
directly or indirectly Controls, is Controlled by or is under
common Control with such first Person. A Person will be deemed to
“ Control ” another Person if such first Person
has the power to direct or cause the direction of the management
and policies of such other Person, whether through ownership of
securities, by contract or otherwise.
“ Agreement
” has the meaning set forth in the introductory
paragraph.
“ Agreement Date
” has the meaning set forth in the introductory
paragraph.
“ Assigned
Contracts ” mean the Contracts listed on Schedule
5.8 , but only to the extent noted on Schedule 5.8 (
i.e. , as to certain listed Contracts, not all rights and
obligations are being assigned – as more fully noted on
Schedule 5.8 ); provided , however , that
notwithstanding any provision herein to the contrary, where the
consent of any other Person is necessary (as identified on
Schedule 5.8 ) in order for any interest of Seller or any of
Seller’s Affiliates in any such Contract to be assigned to
Buyer, such Contract shall not be deemed to be an Assigned Contract
unless and until either (i) such consent is obtained or
(ii) Buyer and Seller separately agree ( i.e. , outside
of this Agreement and the arrangements contemplated hereby,
including the Contract Assignment and Assumption Agreement) to
include such Contract as an Assigned Contract.
“ Assumed
Contractual Obligations ” mean the obligations of Seller
or any of Seller’s Affiliates under the Assigned Contracts
from and after the Closing Date; provided , however ,
that Assumed Contractual Obligations shall not include any
obligations that arise due to a breach or default under the
Assigned Contracts prior to Closing.
“ Biosimilar
Product ” means a biosimilar product approved by the FDA
based upon reference to the prior approval of the Product (and the
clinical data supporting such approval) to which such biosimilar
product is therapeutically equivalent.
“ Books and
Records ” mean all pricing lists, customer lists,
material customer correspondence and related material books and
records used solely and specifically with respect to the Product in
the United States by Seller or any of Seller’s Affiliates,
but in each instance only to the extent in existence as of the
Closing Date and readily within the possession or control of Seller
or any of Seller’s Affiliates.
“ Business Day
” means any day other than a Saturday, Sunday or other day on
which banks in the City of New York are permitted or required to
close by any Governmental Rule.
“ Buyer ”
has the meaning set forth in the introductory paragraph.
“ Buyer Indemnified
Parties ” has the meaning set forth in
Section 12.2(a) .
“ Closing
” has the meaning set forth in Section 4.1
.
“ Closing Date
” has the meaning set forth in Section 4.1
.
“ CMS-HHS
” means the Centers for Medicare & Medicaid Service
of the United States Department of Health and Human
Services.
“
Commercialization ” means any (i) sales of the
Product or Finished US Goods, or any portion of any of the
foregoing, for ultimate use in the United States or (ii) other
commercial activities related to the Product in the United
States.
“ Confidential
Information ” means information which is confidential or
proprietary to the Disclosing Party, including know-how, scientific
information, the terms of this Agreement or any other Transaction
Document, clinical data, efficacy and safety data, adverse event
information, formulas, methods and processes, specifications,
pricing information (including
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
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discounts, rebates and other price
adjustments) and other terms and conditions of sales, customer
information, business plans and all other intellectual property;
provided , however , that Confidential Information
shall not include the following: (i) information of a
Disclosing Party that is known to a Receiving Party or its
Affiliates prior to the time of disclosure to it, to the extent
evidenced by written records or other competent proof, unless a
proprietary interest in such information is transferred to the
Disclosing Party pursuant to this Agreement or any other
Transaction Document; (ii) information that is independently
developed by employees, agents or independent contractors of a
Receiving Party or its Affiliates without reference to or reliance
upon the information furnished by the Disclosing Party, as
evidenced by written records or other competent proof, unless a
proprietary interest in such information is transferred to the
Disclosing Party pursuant to this Agreement or any other
Transaction Document; (iii) information disclosed to a
Receiving Party or its Affiliates by a third Person that has a
right to make such disclosure; or (iv) any other information
that is or becomes part of the public domain through no fault or
negligence of the Receiving Party.
“ Confidentiality
Agreement ” means that certain confidentiality agreement,
dated as of April 26, 2007, by and between Buyer and
Seller.
“ Contracts
” mean contracts, leases, indentures, agreements, notes,
bonds, loans, instruments, conditional sale contracts, mortgages,
licenses, purchase orders and all other legally binding
arrangements or commitments, whether written or oral or in
existence on the Agreement Date or subsequently entered into,
including all amendments thereto.
“ Contract
Assignment and Assumption Agreement ” means the
assignment and assumption agreement to be executed and delivered by
Buyer and Seller at the Closing substantially in the form of
Exhibit A .
“ Customer
Orders ” mean orders for Finished US Goods from customers
of Seller or any of Seller’s Affiliates in the United
States.
“ Disclosing
Party ” has the meaning set forth in
Section 9.6(a) .
“ Disclosure
Schedule ” means the Disclosure Schedule delivered by
Seller to Buyer concurrently with delivering this
Agreement.
“ Disputes
” has the meaning set forth in Section 5.10(d)
.
“ Encumbrance
” means any mortgage, charge, lien, security interest,
easement, right of way, pledge or any similar encumbrance of any
nature whatsoever.
“ Excluded
Assets ” has the meaning set forth in
Section 2.2(b) .
“ Excluded
Intellectual Property ” means: (i) the Licensed
Patents; (ii) the Sublicensed Patent Rights; (iii) the
Sublicensed Patent Rights Agreements; (iv) the Seller Trade
Dress; (v) the Seller Trademarks; (vi) any computer
programs and software; and (vii) any other copyrights,
Patents, trade dress, Trademarks or other intellectual property
that does not relate solely and specifically to the development,
manufacture, marketing, sale or distribution of the Product (except
as expressly included in the Product Intellectual
Property).
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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“ FDA ”
means the United States Food and Drug Administration.
“ FFDCA ”
means the Federal Food, Drug, and Cosmetic Act of 1938, as
amended.
“ Finished US
Goods ” mean kits containing the Product labeled and
ready for distribution and sale to end-users in the United States,
as contemplated by the definition for such term in the Supply
Agreement; provided , however , that for purposes of
this Agreement, such term shall also include any single such kit
containing one of the constituent parts of the Product.
“ General Assignment
and Assumption Agreement ” means the assignment and
assumption agreement to be executed and delivered by Buyer and
Seller at the Closing substantially in the form of Exhibit B
.
“ General Assignment
and Bill of Sale ” means the assignment and bill of sale
to be executed and delivered by Seller at the Closing substantially
in the form of Exhibit C .
“ Governmental
Entity ” means any court, administrative agency or
commission or other governmental or regulatory authority or
instrumentality of applicable jurisdiction, whether domestic or
foreign.
“ Governmental
Rule ” means any applicable law, judgment, order, award,
decree, statute, ordinance, rule or regulation issued or
promulgated by any Governmental Entity.
“ HSR Act
” means the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended.
“ Indemnified
Party ” has the meaning set forth in
Section 12.6(a) .
“ Indemnifying
Party ” has the meaning set forth in
Section 12.6(a) .
“ Integrity
Agreement ” means a corporate integrity agreement to be
entered into by and between Buyer and OIG-HHS.
“ Knowledge of
Seller ” means the actual knowledge of Faheem
Hasnain.
“ Liabilities
” mean any and all debts, liabilities and obligations,
whether accrued or fixed, absolute or contingent, matured or
unmatured or determined or determinable, including those arising
under any Governmental Rule, Contract or otherwise.
“ License
Agreement ” means the license agreement to be executed
and delivered by Buyer and Seller at the Closing substantially in
the form of Exhibit D .
“ License-Back
Agreement ” means the license-back agreement to be
executed and delivered by Buyer and Seller at the Closing
substantially in the form of Exhibit E .
“ Licensed
Patents ” mean the Patents listed on Schedule 5.10
.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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“ Losses ”
mean any and all damages, losses, Taxes, Liabilities, claims,
judgments, penalties, costs and expenses, including reasonable
attorneys’ fees and litigation expenses.
“ Manufacturing
Confidential Information ” means Confidential Information
relating to the manufacture or supply of the Product or Finished US
Goods, or any portion of any of the foregoing, including Product
Manufacturing Technology (as defined in the Supply Agreement), that
is (i) disclosed to Buyer or any of its Affiliates by Seller
or any of its Affiliates (including through observation by Buyer or
any of its Affiliates) and (ii) maintained as confidential by
Seller and its Affiliates prior to such disclosure; provided
, however , that Manufacturing Confidential Information
shall not include (x) information disclosed to Buyer or any of
its Affiliates by a third Person (excluding, for this purpose,
Seller or any of its Affiliates) that has a right to make such
disclosure or (y) any other information that is or becomes
part of the public domain through no fault or negligence of Buyer
or any of its Affiliates or any third party manufacturer engaged by
Buyer or any of its Affiliates.
“ Material Adverse
Effect ” means a change, circumstance or effect that has
had a materially adverse effect on the Purchased Assets taken as a
whole, but excluding any change, circumstance or effect caused by
or relating to: (i) changes in conditions generally affecting
(A) the healthcare or biotechnology industry or (B) the
United States or world economy or securities markets; (ii) the
execution or announcement of this Agreement or the consummation of
the transactions contemplated hereby, including any loss of
employees, suppliers or customers resulting therefrom;
(iii) changes in any Governmental Rule or generally accepted
accounting principles or interpretations thereof; (iv) any act
of civil unrest, war or terrorism; or (v) a decline in
revenues of or orders for the Product.
“ Milestone
Events ” has the meaning set forth in
Section 3.3 .
“ Milestone
Payments ” has the meaning set forth in
Section 3.3 .
“ NDC Number
” means either of the national drug code numbers associated
with the Product as of the Agreement Date, No. 64406-104-04 or
No. 64406-103-03.
“ OIG-HHS
” means the Office of Inspector General of the United States
Department of Health and Human Services.
“ Patent
Assignment ” means the patent assignment to be executed
and delivered by Seller at the Closing substantially in the form of
Exhibit F .
“ Patents
” mean all United States patents and patent applications,
including reissues, divisions, continuations, continuations-in-part
and extensions thereof and reexamination certificates
therefor.
“ Person ”
means any individual, corporation, partnership, limited liability
company, joint venture, trust, business association, organization,
Governmental Entity or other entity.
“ Post-BLA Clinical
Trial Records ” mean all final reports and other material
records for clinical studies with respect to the Product in the
United States, but in each instance only to the
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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extent: (i) in existence as of the
Closing Date; (ii) readily within the possession of, and
controlled and transferable by, Seller or any of Seller’s
Affiliates; and (iii) relating to any study that commenced
after February 19, 2002.
“ Post-Closing
Liabilities ” has the meaning set forth in
Section 2.3(a) .
“ Pre-Closing
Liabilities ” has the meaning set forth in
Section 2.3(b) .
“ Product
” means the pharmaceutical product currently marketed and
sold as ZEVALIN ® (Ibritumomab Tiuxetan), consisting of
Indium-111 Ibritumomab Tiuxetan and Yttrium-90 Ibritumomab
Tiuxetan, as such term is more particularly defined in the Supply
Agreement.
“ Product Domain
Names ” mean the Internet domain names listed on
Schedule 5.10 .
“ Product
Intellectual Property ” means: (i) the Product
Domain Names; (ii) the Product Patents; (iii) the Product
Trade Dress; and (iv) the Product Trademarks.
“ Product Marketing
Materials ” mean all sales training, marketing and other
promotional materials used solely and specifically with respect to
the Product in the United States by Seller or any of Seller’s
Affiliates, but in each instance only to the extent in existence as
of the Closing Date and readily within the possession or control of
Seller or any of Seller’s Affiliates.
“ Product
Patents ” mean the United States patents and patent
applications listed on Schedule 5.10 , including reissues,
divisions, continuations, continuations-in-part and extensions
thereof and reexamination certificates therefor.
“ Product Trade
Dress ” means the current trade dress of the Product, but
excluding Seller Trade Dress.
“ Product
Trademarks ” mean the Trademarks listed on Schedule
5.10 .
“ Product Toll-Free
Number ” means the 1-866-298-8433 telephone
number.
“ Purchase Price
” has the meaning set forth in Section 3.1
.
“ Purchased
Assets ” has the meaning set forth in
Section 2.2(a) .
“ Rebates
” mean all payments, rebates, reimbursements, administrative
fees or chargebacks due (i) under any state or federal program
in the United States (including Medicaid) or (ii) to customers
in the United States under any private party managed care Contract
or under any other Contract or program of any nature whatsoever
with private Persons.
“ Receiving
Party ” has the meaning set forth in
Section 9.6(a) .
“ Regulatory
Applications/Approvals ” mean Biologics License
Application No. 125019, as initially approved by the FDA on
February 19, 2002, and all supplements,
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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amendments and revisions thereto,
whether approved or not, together with all supporting documents and
clinical studies referenced in any such applications and relating
solely and specifically to the Product and all annual reports and
postmarketing fifteen (15)-day alerts submitted since the most
recent such annual report with respect thereto, but in each
instance only to the extent: (i) in existence as of the
Closing Date; (ii) in the possession of, and controlled and
transferable by, Seller or any of Seller’s Affiliates; and
(iii) not necessary or appropriate to be retained by Seller in
order for Seller to (A) manufacture the Product under the
terms of the Supply Agreement or the Schering Supply Agreement or
(B) perform obligations following the Closing where
performance is expected to be transitioned to Buyer pursuant to the
Services Agreement.
“ Regulatory
Files ” mean (i) all adverse event reports and other
data, information and materials relating to adverse experiences
solely and specifically with respect to the Product in the United
States and (ii) all material correspondence between Seller or
any of Seller’s Affiliates, on the one hand, and any
Governmental Entity, on the other hand, relating solely and
specifically to the Product in the United States, including any
safety reports or updates, complaint files and product quality
reviews, but in each instance only to the extent: (x) in
existence as of the Closing Date; (y) in the possession or
control of Seller or any of Seller’s Affiliates; and
(z) not necessary or appropriate to be retained by Seller in
order for Seller to (A) manufacture the Product under the
terms of the Supply Agreement or the Schering Supply Agreement or
(B) perform obligations following the Closing where
performance is expected to be transitioned to Buyer pursuant to the
Services Agreement.
“ Schering
” means Schering Aktiengesellschaft, a German
corporation.
“ Schering License
Agreement ” means that certain Collaboration &
License Agreement, dated June 9, 1999, by and between Schering
and IDEC Pharmaceuticals Corporation, as amended by that certain
First Amendment to Collaboration & License Agreement,
dated July 13, 2004, by and between Schering and Seller and
that certain letter agreement amendment, dated September 16,
2005, by and between Schering and Seller, as the same may be
amended from time to time (so long as any such amendment does not
provide Schering or any successor or assignee with a right to offer
to sell, sell, import or distribute the Product in the United
States).
“ Schering
Pharmacovigilance Agreement ” means that certain
Pharmacovigilance Agreement, dated April 30, 2003, by and
between Schering and IDEC Pharmaceuticals Corporation, as the same
may be amended from time to time (so long as any such amendment
does not provide Schering or any successor or assignee with a right
to offer to sell, sell, import or distribute the Product in the
United States).
“ Schering Supply
Agreement ” means that certain Supply Agreement, dated
June 9, 1999, by and between Schering and IDEC Pharmaceuticals
Corporation, as amended by that certain letter agreement amendment,
dated December 16, 2004, by and between Schering and Seller,
as the same may be amended from time to time (so long as any such
amendment does not provide Schering or any successor or assignee
with a right to offer to sell, sell, import or distribute the
Product in the United States).
“ Security
Agreement ” means a security agreement to be executed and
delivered by Seller and Buyer at the Closing substantially in the
form of Exhibit G .
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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“ Seller ”
has the meaning set forth in the introductory paragraph.
“ Seller Cap
Amount ” has the meaning set forth in
Section 12.2(b)(ii) .
“ Seller Indemnified
Parties ” has the meaning set forth in
Section 12.3 .
“ Seller Trade
Dress ” means the lay-out, designs and coloring used on
the packaging of the Product to the extent used on other product
packaging of Seller or any of Seller’s Affiliates.
“ Seller
Trademarks ” mean: (i) the “Biogen Idec”
name or any variations thereof; (ii) the names
“Biogen”, “Idec” and all formatives and
derivatives thereof, all composite marks including such names or
any such formatives or derivatives and any colorable imitation of
any of the foregoing; and (iii) all Trademarks, other than the
Product Trademarks, used by Seller or any of Seller’s
Affiliates in connection with the manufacture, marketing, sale and
distribution of the Product.
“ Services
Agreement ” means a services agreement to be executed and
delivered by Seller and Buyer at the Closing substantially in the
form of Exhibit H .
“ Sublicense
Agreements ” mean the sublicense agreements or other
arrangements with respect to the Sublicensed Patent Rights under
the Sublicensed Patent Rights Agreements to be executed and
delivered by Buyer and Seller at the Closing in the forms prepared
pursuant to Section 9.4(a) , all of which are intended
to “pass-through” the applicable obligations (including
economic arrangements) of the Sublicensed Patent Rights Agreements
from Seller to Buyer ( i.e. , without any premium or
surcharge payable by Buyer to Seller). Sublicense Agreements shall
include, as applicable, all amendments or novations of Sublicensed
Patent Rights Agreements necessary to achieve such
pass-through.
“ Sublicensed Patent
Rights ” mean the rights of Seller or any of
Seller’s Affiliates to Patents under the Sublicensed Patent
Rights Agreements, but solely to the extent that such rights relate
solely and specifically to the development, manufacture or sale of
the Product in the United States where such Product will only be
sold to, or used by, end-users in the United States.
“ Sublicensed Patent
Rights Agreements ” mean those certain license agreements
to which Seller or any of Seller’s Affiliates is a party
listed on Schedule 5.10 .
“ Submission
Window ” has the meaning set forth in
Section 6.6 .
“ Supply
Agreement ” means a supply agreement to be executed and
delivered by Seller and Buyer at the Closing substantially in the
form of Exhibit I .
“ Tax ”
means all domestic and foreign taxes and assessments, including all
interest, penalties and additions with respect thereto.
“ Tax Return
” means any report, return, election, notice, estimate,
declaration,
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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information statement and other forms
and documents (including all schedules, exhibits and other
attachments thereto) relating to and filed or required to be filed
with a taxing authority in connection with any Taxes (including
estimated Taxes).
“ Third Party
Claim ” has the meaning set forth in
Section 12.6(b) .
“ Trademark
Assignment ” means the trademark assignment to be
executed and delivered by Seller at the Closing substantially in
the form of Exhibit J .
“ Trademarks
” mean all United States trademarks, trade names, brand
names, logotypes, symbols, service marks, Internet domain names and
the goodwill of the business symbolized thereby, including
registrations and applications for registrations thereof and all
renewals, modifications and extensions thereof.
“ Transaction
Documents ” mean this Agreement, the Contract Assignment
and Assumption Agreement, the General Assignment and Assumption
Agreement, the General Assignment and Bill of Sale, the License
Agreement, the License-Back Agreement, the Patent Assignment, the
Security Agreement, the Services Agreement, the Supply Agreement,
the Sublicense Agreements, the Trademark Assignment and the
Transition Services Agreement.
“ Transition
Services Agreement ” means a transition services
agreement to be executed and delivered by Seller and Buyer at the
Closing substantially in the form of Exhibit K .
“ United States
” means the United States of America, together with all of
its territories and possessions, and the Commonwealth of Puerto
Rico.
“ USPTO ”
means the United States Patent and Trademark Office.
“ Yearly Net Sales
Amount ” means, with respect to the applicable calendar
year, the total amount invoiced by Buyer or any of its direct or
indirect Affiliates, assignees, successors, licensees, transferees,
distributors or commercial partners (or their respective
Affiliates) for sales of the Product or Finished US Goods, or any
portion of any of the foregoing, to third parties in bona fide
arm’s length transactions less the following deductions, in
each case related specifically to the Product or Finished US Goods,
or any portion of any of the foregoing, as applicable, and actually
taken by such third parties and not otherwise recovered or
reimbursed to Buyer or any of its direct or indirect Affiliates,
assignees, successors, licensees, transferees, distributors or
commercial partners (or their respective Affiliates): (i) the
actual cost of such Product or Finished US Goods, or any portion of
any of the foregoing, paid to Seller pursuant to the Supply
Agreement; (ii) credits or refunds for actual returns of such
Product or Finished US Goods, or any portion of any of the
foregoing; (iii) Rebates for the purchase of such Product or
Finished US Goods, or any portion of any of the foregoing;
(iv) sales, use or similar Taxes directly related to the sale
of such Product or Finished US Goods, or any portion of any of the
foregoing, but only to the extent added to the sales price and
separately set forth as such in the total invoiced amount; and
(v) freight, packing and handling charges to the extent
directly related to the sale of such Product or Finished US Goods,
or any portion of any of the foregoing, but only to the extent
added to the sales price and separately set forth as such in the
total invoiced amount. The gross invoiced amounts referred to in
the foregoing sentence exclude amounts
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invoiced among Buyer, its Affiliates and
its licensees for quantities of Product or Finished US Goods, or
any portion of any of the foregoing, for resale ( i.e. ,
where the resale is included in the Yearly Net Sales Amount). If
any of the Product or Finished US Goods, or any portion of any of
the foregoing, is ever sold for compensation other than cash or in
a transaction which is not arm’s length, or if Product or
Finished US Goods, or any portion of any of the foregoing, would
otherwise reach patients or end-users without a sale thereof being
included in the calculation of the Yearly Net Sales Amount (other
than pursuant to any clinical trial, commercially reasonable
sampling program, compassionate use program or the like), then the
then-current gross list price of such Product or Finished US Goods,
or any applicable portion of any of the foregoing, shall be used in
calculating, for the quantities at issue, the Yearly Net Sales
Amount.
“ Yearly Royalty
Payment ” has the meaning set forth in
Section 3.4(a) .
“ Yearly Royalty
Payment Expiration Date ” has the meaning set forth in
Section 3.4(c) .
Section 1.2
Interpretation .
(a) When used in this
Agreement, the words “include,” “includes”
and “including” shall be deemed to be followed by the
words “without limitation.”
(b) Any terms defined in the
singular shall have a comparable meaning when used in the plural,
and vice-versa.
(c) All references to any
introductory paragraph, recitals, Articles, Sections, Exhibits and
Schedules shall be deemed references to the introductory paragraph,
recitals, Articles, Sections, Exhibits and Schedules to this
Agreement unless otherwise specifically set forth
herein.
(d) This Agreement shall be
deemed drafted jointly by Buyer and Seller and shall not be
specifically construed against either party based on any claim that
such party or its counsel drafted this Agreement.
Section 1.3
Currency . All currency amounts referred to in this
Agreement are in United States Dollars unless otherwise
specified.
ARTICLE II
SALE AND PURCHASE OF
PURCHASED ASSETS
Section 2.1 Purchase
and Sale . Upon the terms and subject to the conditions of this
Agreement, on the Closing Date, Seller shall, and shall cause
certain of Seller’s Affiliates to, sell, assign, transfer,
convey and deliver to Buyer, and Buyer shall purchase, acquire and
accept, all right, title and interest of Seller or any of
Seller’s Affiliates in, to and under the Purchased
Assets.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
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Section 2.2 Purchased
Assets .
(a) “ Purchased
Assets ” means the following properties, assets and
rights of Seller or any of Seller’s Affiliates:
(i) the Assigned
Contracts;
(ii) the Books and
Records;
(iii) the Post-BLA Clinical
Trial Records;
(iv) the Product Domain
Names;
(v) the Product Marketing
Materials;
(vi) the Product
Patents;
(vii) the Product Toll-Free
Number;
(viii) the Product Trade
Dress;
(ix) the Product
Trademarks;
(x) the Regulatory
Applications/Approvals;
(xi) the Regulatory Files;
and
(xii) all unfilled Customer
Orders as of the Closing Date ( i.e. , Customer Orders to
the extent that (A) the Finished US Goods at issue have not
been shipped to the applicable customer as of the Closing Date and
(B) Buyer (rather than Seller or any of its Affiliates) would
be paid by the applicable customer after shipment by Buyer
following the Closing Date), a list of which shall be provided to
Buyer within ten (10) Business Days after the Closing
Date.
(b) Notwithstanding the
foregoing, or any other provision herein to the contrary, Buyer and
Seller expressly agree and acknowledge that the Purchased Assets
shall not include any of the following (collectively, the “
Excluded Assets ”):
(i) any tangible property
(except as expressly included in the Purchased Assets
above);
(ii) the Schering License
Agreement, the Schering Pharmacovigilance Agreement and the
Schering Supply Agreement;
(iii) the right to sue under
any of the Purchased Assets for events or circumstances occurring
prior to the Closing Date;
(iv) the Excluded
Intellectual Property; and
(v) all properties, assets
and rights of Seller or any of Seller’s Affiliates other than
the Purchased Assets.
***CERTAIN INFORMATION IN THIS EXHIBIT
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
11
(c) Buyer acknowledges and
agrees that Seller and any of Seller’s Affiliates may retain
(and be entitled to use the information in) copies of any or all
parts of the documentation that Seller or any of Seller’s
Affiliates deliver to Buyer hereunder or that otherwise constitute
Purchased Assets: (i) for archival purposes; (ii) to
fulfill or otherwise dispose of any of the Pre-Closing Liabilities;
(iii) to fulfill or otherwise dispose of any of Seller’s
or any of Seller’s Affiliates rights or obligations under the
Security Agreement, the Services Agreement, the Supply Agreement or
the Transition Services Agreement; (iv) for use in connection
with any pending or threatened Action; (v) to fulfill or
otherwise dispose of any of Seller’s or any of Seller’s
Affiliates obligations under the Schering License Agreement, the
Schering Pharmacovigilance Agreement or the Schering Supply
Agreement; or (vi) for such other purposes as Seller may
reasonably request, subject to Buyer’s prior written consent
(which consent shall not be unreasonably withheld, conditioned or
delayed).
Section 2.3
Pre-Closing and Post-Closing Liabilities . Except
(i) as otherwise provided in the Supply Agreement and
(ii) for such allocations of liability between the parties as
are expressly set forth in the Services Agreement and the
Transition Services Agreement:
(a) Buyer, and not Seller or
any of its Affiliates, shall be liable, as between Seller and its
Affiliates on the one hand and Buyer and its Affiliates on the
other hand, for any and all Liabilities and Actions to the extent
arising in connection with the Commercialization, the Purchased
Assets or any acts or omissions of Buyer or any of its direct or
indirect Affiliates, assignees, successors, licensees, transferees,
distributors or commercial partners (or their respective
Affiliates) related thereto from and after the Closing Date,
including Assumed Contractual Obligations (collectively, the
“ Post-Closing Liabilities ,” as further
illustrated by subsections (c) and (d)
below); provided , however , that Post-Closing
Liabilities shall specifically not include any manufacturing or
purchase orders for materials delivered to or on behalf of Seller
prior to the Closing Date or any rebates to be paid on Product
sales made prior to the Closing Date;
(b) Seller, and not Buyer or
any of its Affiliates, shall be liable, as between Buyer and its
Affiliates on the one hand and Seller and its Affiliates on the
other hand, for any and all Liabilities and Actions to the extent
arising in connection with the Commercialization, the Purchased
Assets or any acts or omissions of Seller or any of its direct or
indirect Affiliates, assignees, successors, licensees, transferees,
distributors or commercial partners (or their respective
Affiliates) related thereto prior to the Closing Date
(collectively, the “ Pre-Closing Liabilities ,”
as further illustrated by subsections (c) and
(d) below), and Buyer will not assume or be
responsible for any Pre-Closing Liabilities; provided ,
however , that any manufacturing or purchase orders for
materials delivered to or on behalf of Seller prior to the Closing
Date and any rebates to be paid on Product sales made prior to the
Closing Date shall also be specifically included in Pre-Closing
Liabilities; and
(c) For the avoidance of
doubt, by way of example, the Post-Closing Liabilities shall
include any Liabilities and Actions to the extent arising in
connection with any quantities of Product sold (or in the
alternative, if Product at issue was not sold, then
***CERTAIN INFORMATION IN THIS EXHIBIT
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
12
administered to or taken by a patient)
in the United States after the Closing Date, and the Pre-Closing
Liabilities shall include any Liabilities and Actions to the extent
arising in connection with any quantities of Product sold (or in
the alternative, if Product at issue was not sold, then
administered to or taken by a patient) prior to the Closing Date.
It is hereby acknowledged that an Action initiated by a patient
taking Product in the United States both before and after the
Closing may involve both Pre-Closing Liabilities and Post-Closing
Liabilities, in which event the parties shall cooperate with one
another to determine and implement an appropriate strategy for
defending against any related Actions.
(d) For the avoidance of
doubt, by way of example, the Post-Closing Liabilities (and the
Assumed Contractual Obligations) shall include (and the Pre-Closing
Liabilities shall exclude) any payment obligation that first
becomes due and payable under an Assigned Contract after the
Closing Date, even to the extent that such payment obligation may
relate to activities under such Assigned Contract that are
substantially performed before the Closing Date.
ARTICLE III
PURCHASE
PRICE
Section 3.1 Purchase
Price . The purchase price for the Purchased Assets shall be
Ten Million Dollars ($10,000,000) in cash (the “ Purchase
Price ”), which shall be payable at the Closing in
accordance with Section 4.2(b) .
Section 3.2
Allocation of Purchase Price . The Purchase Price shall be
allocated among the Purchased Assets as of the Closing Date in
accordance with any Governmental Rule and as otherwise agreed upon
in writing by the parties. Buyer and Seller each agree to
(i) report (and to cause its respective Affiliates to report)
the transactions contemplated by this Agreement in a manner
consistent with any Governmental Rule and with the terms of this
Agreement (including the allocation agreed upon in writing by the
parties) and (ii) not to take any position inconsistent
therewith in any Tax Return, in any Tax refund claim, in any
litigation or otherwise.
Section 3.3 Milestone
Payments . In addition to the Purchase Price and the Yearly
Royalty Payments, within thirty (30) days after each of the
Milestone Events Buyer shall pay to Seller the corresponding
Milestone Payment by wire transfer in immediately available funds
to an account or accounts designated in writing by Seller. The
Milestone Events and the corresponding Milestone Payments are as
follows:
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|
|
|
|
“Milestone Events”
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|
“Milestone Payments” |
| Approval
from the FDA to expand the labeling for the Product with respect to
an aggressive non-Hodgkin’s lymphoma indication |
|
$ |
10,000,000 |
|
|
| Approval
from the FDA to expand the labeling for the Product with respect to
an indolent non-Hodgkin’s lymphoma indication |
|
$ |
10,000,000 |
***CERTAIN INFORMATION IN THIS EXHIBIT
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
13
Buyer acknowledges and agrees that more
than one of the Milestone Events could occur in any calendar year
and that such an occurrence would not reduce any of the applicable
Milestone Payments.
Section 3.4 Yearly
Royalty Payments .
(a) In addition to the
Purchase Price and the Milestone Payments, on or before
March 1 of each calendar year starting with March 1, 2008
and continuing until March 1 of the calendar year following
the Yearly Royalty Payment Expiration Date, Buyer shall pay to
Seller the Yearly Royalty Payment for the preceding calendar year
by wire transfer in immediately available funds to an account or
accounts designated in writing by Seller. The “ Yearly
Royalty Payment ” shall be equal to a percentage of the
Yearly Net Sales Amount for the preceding calendar year as follows
(noting, for this purpose, that the Yearly Royalty Payment will be
the sum of the two separate amounts if and when more than one
percentage calculation applies in calendar years 2007 through
2013):
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|
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Yearly
Net Sales Amount
|
|
Percentage
|
| For
calendar years 2007 through 2010 and that increment of the Yearly
Net Sales Amount below $250,000,000 |
|
[***] |
|
|
| For
calendar years 2007 through 2010 and that increment of the Yearly
Net Sales Amount equal to or in excess of $250,000,000 |
|
[***] |
|
|
| For
calendar years 2011 through 2013 and that increment of the Yearly
Net Sales Amount below $250,000,000 |
|
[***] |
|
|
| For
calendar years 2011 through 2013 and that increment of the Yearly
Net Sales Amount equal to or in excess of $250,000,000 |
|
[***] |
|
|
| For
calendar years 2014 or later and all increments of the Yearly Net
Sales Amount |
|
[***] |
(b) Assuming a Closing, then
on or before March 1 of each calendar year starting with
March 1, 2008 and continuing until March 1 of the
calendar year following the Yearly Royalty Payment Expiration Date,
Buyer shall deliver to Seller a written report, certified as
accurate by an officer of Buyer, stating the Yearly Net Sales
Amount for the preceding calendar year (but only for that period
following the Closing Date in the instance of 2007) and the Yearly
Royalty Payment for the preceding calendar year. In no event shall
the receipt or acceptance by Seller of such report or a Yearly
Royalty Payment prevent Seller from subsequently challenging the
validity or accuracy of such report or a Yearly Royalty Payment.
Buyer shall keep, and require its direct or indirect Affiliates,
assignees, successors, licensees, transferees, distributors or
commercial partners (or their respective Affiliates) to keep, full,
complete and proper records and accounts of all sales of the
Product or Finished US Goods, or any portion of any of the
foregoing, in sufficient detail to enable the Yearly Royalty
Payment to
***CERTAIN INFORMATION IN THIS EXHIBIT
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
14
be determined. Seller shall have the
right to appoint an independent certified public accounting firm
approved by Buyer (which approval shall not be unreasonably
withheld, conditioned or delayed) to audit the records of Buyer or
any of its direct or indirect Affiliates, assignees, successors,
licensees, transferees, distributors or commercial partners (or
their respective Affiliates) as necessary to verify a Yearly
Royalty Payment. Buyer shall pay to Seller an amount equal to any
additional portion of a Yearly Royalty Payment to which Seller is
entitled as disclosed by such audit plus a late charge thereon at
the rate of one and one-half percent (1.5%) per month. Such
audit shall be at Seller’s expense; provided ,
however , that if such audit discloses that Seller was
underpaid a Yearly Royalty Payment by at least five percent (5%),
then Buyer shall reimburse Seller for the reasonable costs of such
audit. Seller may exercise its right to audit as to each of Buyer
or any of its direct or indirect Affiliates, assignees, successors,
licensees, transferees, distributors or commercial partners (or
their respective Affiliates) no more frequently than once in any
calendar year or more than once in respect of any calendar year,
and the accounting firm performing such audit shall execute a
confidentiality agreement enforceable by Buyer that prohibits the
accounting firm from divulging information obtained in connection
with the audit (other than the disclosure to Seller of information
relating to the accuracy of the Yearly Royalty Payment). Any such
audit shall be permitted during business hours within fifteen
(15) days of Buyer’s receipt of Seller’s notice to
proceed with an audit. Buyer shall preserve and maintain, and cause
its direct or indirect Affiliates, assignees, successors,
licensees, transferees, distributors or commercial partners (or
their respective Affiliates) to preserve and maintain, all books
and records required for such an audit for a period of at least
five (5) years after the calendar year to which the books and
records apply.
(c) For the calendar year in
which the Yearly Royalty Payment Expiration Date occurs, the Yearly
Net Sales Amount shall only be calculated for that portion of such
calendar year prior to the Yearly Royalty Payment Expiration Date.
The “ Yearly Royalty Payment Expiration Date ”
means the latest of: (i) the expiration date of the last to
expire of any of the Product Patents, the Licensed Patents or the
Patents for which a sublicense has been granted to Buyer under the
Sublicense Agreements; (ii) the day on which a third Person
begins to lawfully sell a Biosimilar Product in the United States
of America; or (iii) December 31, 2015.
Section 3.5 Transfer
Taxes . All transfer, sales, value added, stamp duty and
similar Taxes payable in connection with the transactions
contemplated hereby, to the extent payable to any Governmental
Entity, shall be borne by Buyer. Notwithstanding the foregoing,
Buyer and Seller shall each be obligated for any Taxes to the
extent payable or assessed based upon the income or worth of such
party.
ARTICLE IV
THE CLOSING
Section 4.1 Closing
Date . The closing of the sale and transfer of the Purchased
Assets (the “ Closing ”) shall take place at
Seller’s offices at 5200 Research Place, San Diego,
California 92122, on the first Business Day following the date on
which all of the conditions to each party’s obligations under
Article X have been satisfied or waived, or at such other
date or place as may be mutually agreed to by Buyer and Seller
(such date of the Closing being the “ Closing Date
”).
***CERTAIN INFORMATION IN THIS EXHIBIT
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
15
Section 4.2 Closing
Activities .
(a) At the Closing,
(i) Seller shall deliver or cause to be delivered to Buyer
each of the items referred to in Section 10.2(a) ,
(b) and (d) , in each case appropriately
executed, and (ii) Buyer shall deliver or cause to be
delivered to Seller each of the items referred to in
Section 10.3(a) , (b) and (c) , in
each case appropriately executed.
(b) At the Closing, Buyer
shall deliver or cause to be delivered to Seller payment of the
Purchase Price by wire transfer in immediately available funds to
an account or accounts designated in writing by Seller.
ARTICLE V
REPRESENTATIONS AND
WARRANTIES OF SELLER
Seller hereby represents and
warrants to Buyer, except as set forth on the Disclosure Schedule,
as follows:
Section 5.1
Organization; Good Standing . Seller is a corporation duly
organized, validly existing and in good standing under the laws of
the State of Delaware. Each of Seller and Seller’s Affiliates
has the requisite power and authority to own the Purchased Assets,
as the case may be, and to carry on its business with respect to
the Product as currently conducted. Each of Seller and
Seller’s Affiliates is duly qualified to conduct business as
a foreign corporation and is in good standing in each jurisdiction
where the nature of the business conducted by it makes such
qualification necessary, except where the failure to so qualify or
be in good standing would not have a Material Adverse
Effect.
Section 5.2
Authority; Execution and Delivery . Seller has the requisite
power and authority to enter into this Agreement and to consummate
the transactions contemplated hereby. The execution and delivery of
this Agreement by Seller and the consummation of the transactions
contemplated hereby have been duly and validly authorized by Seller
and, as applicable, Seller’s Affiliates. This Agreement has
been duly executed and delivered by Seller and, assuming the due
authorization, execution and delivery of this Agreement by Buyer,
will constitute the legal, valid and binding obligation of Seller,
enforceable against it in accordance with its terms, subject to
applicable bankruptcy, insolvency, reorganization, moratorium,
fraudulent transfer and other similar laws affecting
creditors’ rights generally from time to time in effect and
to general principles of equity regardless of whether considered in
a proceeding in equity or at law.
Section 5.3 No
Violation; Consents . The execution and delivery of this
Agreement or any of the Transaction Documents by Seller and, as
applicable, Seller’s Affiliates do not, and the consummation
of the transactions contemplated hereby or thereby and compliance
with the terms hereof or thereof by Seller and such Seller’s
Affiliates will not: (i) violate any Governmental Rule to
which Seller and such Seller’s Affiliates are subject;
(ii) breach or violate any provision of the Certif
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