EXECUTION COPY
EXHIBIT NO. 10.2
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
AGREEMENT ABOUT EUROPEAN COMMERCIALIZATION OF INTEGRILIN
BY AND AMONG
MILLENNIUM PHARMACEUTICALS, INC.,
SCHERING CORPORATION
AND
SCHERING-PLOUGH, LTD.
JUNE 2004
TABLE OF CONTENTS
PAGE
ARTICLE I DEFINITIONS.............................................2
Section 1.1 "Affiliates"............................................2
Section 1.2 "Central Marketing Authorization".......................2
Section 1.3 "Closing Date"..........................................2
Section 1.4 "Commercialization" or "Commercialize"..................2
Section 1.5 "Country Approval Notice"...............................2
Section 1.6 "Development" or "Develop"..............................2
Section 1.7 "Final Approval Notice".................................2
Section 1.8 "Interim Period"........................................2
Section 1.9 "Liabilities"...........................................2
Section 1.10 "Manufacturing" or "Manufacture"........................3
Section 1.11 "Marks".................................................3
Section 1.12 "Negotiation Period"....................................3
Section 1.13 "New Commercial Licensee"...............................3
Section 1.14 "New Commercial Agreement"..............................3
Section 1.15 "Pharmaceutical Company"................................3
Section 1.16 "Regulatory Authority"..................................3
Section 1.17 "Reporting Agreement"...................................3
Section 1.18 "Trademark".............................................3
Section 1.19 "Transfer(s)"...........................................4
Section 1.20 "Transferring Territory"................................4
Section 1.21 "Transition Period".....................................4
Section 1.22 Additional Definitions..................................4
ARTICLE II IDENTIFICATION OF A NEW COMMERCIAL LICENSEE.............5
Section 2.1 Millennium's Identification of a New Commercial
Licensee................................................5
Section 2.2 Schering's Cooperation..................................5
Section 2.3 Confidentiality.........................................7
Section 2.4 Schering's Diligence Obligations during the Negotiation
Period..................................................7
Section 2.5 Decision Making During the Negotiation Period...........7
Section 2.6 Effect of Failure to Close During the Negotiation
Period..................................................8
ARTICLE III MANAGEMENT DURING THE TRANSITION PERIOD.................9
Section 3.1 Notification of Closing.................................9
Section 3.2 General Principles of Management........................9
Section 3.3 Adverse Event and Product Complaint Reporting
Procedures; Notice of Information Affecting
Marketability of the Product...........................10
Section 3.4 Schering's Diligence Obligations during the Transition
Period.................................................11
Section 3.5 Extension of the Transition Period.....................11
ARTICLE IV INTELLECTUAL PROPERTY LICENSES AND MANAGEMENT..........12
Section 4.1 Termination of IP Licenses Granted to Schering.........12
Section 4.2 Modification of IP Licenses Granted to Millennium......13
Section 4.3 Certain Copyrights and Trademarks......................14
Section 4.4 Scope of Schering Activities...........................15
Section 4.5 Management of Certain Intellectual Property............15
ARTICLE V TRANSFER OF RESPONSIBILITIES BY SCHERING...............16
Section 5.1 Transfer of Regulatory Approvals.......................16
Section 5.2 Transfer of Documents..................................17
Section 5.3 Effects of Transfer of Regulatory Approvals............18
Section 5.4 Costs..................................................20
Section 5.5 Country Approval Notice................................20
Section 5.6 Delay in Transfer of Regulatory Approvals..............20
ARTICLE VI CONFIDENTIALITY........................................21
Section 6.1 Disclosure of this Agreement...........................21
Section 6.2 Disclosure of Other Information........................22
ARTICLE VII CLINICAL DEVELOPMENT...................................22
Section 7.1 Clinical Development During the Negotiation Period.....22
Section 7.2 Clinical Development During the Transition Period......23
Section 7.3 Payment by the New Commercial Licensee of Development
Costs..................................................23
ARTICLE VIII TRANSFERS TO NEW COMMERCIAL LICENSEE; EXPENSE SHARING..24
Section 8.1 Transfers to the New Commercial Licensee...............24
Section 8.2 Manufacturing Expense Sharing..........................25
ARTICLE IX FINANCIAL PROVISIONS...................................25
Section 9.1 Payment................................................25
Section 9.2 Royalties Payable to Schering..........................25
ARTICLE X REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS......28
Section 10.1 Exclusivity Covenant...................................28
Section 10.2 Consents...............................................28
Section 10.3 No Violation of Law and No Breach of Contract..........29
Section 10.4 Sales Representatives' Compliance......................29
Section 10.5 Sales of INTEGRILIN Products...........................29
Section 10.6 Intellectual Property and Documentation................29
Section 10.7 Third Party Contracts..................................30
Section 10.8 Adequacy of Disclosure.................................31
Section 10.9 Product Liability Claims...............................31
Section 10.10 Debarment..............................................31
ARTICLE XI LIABILITY & INDEMNIFICATION............................32
Section 11.1 Pre-Transfer Liability.................................32
Section 11.2 Liability During the Transition Period.................32
Section 11.3 Post-Transfer Liability................................33
Section 11.4 No Effect on Liabilities outside the Transferring
Territory..............................................33
Section 11.5 Indemnification by Schering............................34
Section 11.6 Indemnification by Millennium..........................34
Section 11.7 Procedures.............................................34
Section 11.8 Settlements............................................35
Section 11.9 No Consequential Damages...............................35
Section 11.10 Non-Assertion and Waiver of Certain Claims.............35
ARTICLE XII MISCELLANEOUS..........................................37
Section 12.1 Notices................................................37
Section 12.2 Integration; Survival; Term; Relationship to
Collaboration Agreement and Controlling Provisions.....37
Section 12.3 Governing Law; Dispute Resolution......................38
Section 12.4 Intended Third Party Beneficiary.......................39
Section 12.5 Assignment.............................................39
Section 12.6 Execution in Counterparts; Facsimile Signatures........39
EXHIBITS
Exhibit A - Language to be Incorporated into Press Release (Section 6.1)
Exhibit B - Disclosure Schedule 10.6(c)
Exhibit C - Ongoing Development Activities
Exhibit D - INTEGRILIN Sales Information
AGREEMENT ABOUT EUROPEAN COMMERCIALIZATION OF INTEGRILIN
This Agreement is made and effective as of the latest date of signature
appearing below (the "Effective Date") by and among:
Millennium Pharmaceuticals, Inc., a Delaware corporation having its
principal place of business at 00 Xxxxxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxxxxxxx 00000, X.X.X. ("Millennium");
Schering Corporation, a New Jersey corporation having its principal
place of business at 0000 Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx,
Xxx Xxxxxx 00000, X.X.X. ("Schering Corporation"); and
Schering-Plough, Ltd., a corporation organized under the laws of
Switzerland having its principal place of business at Xxxxxxxxxx 00,
X.X. Xxx, XX-0000, Xxxxxxx 0, Xxxxxxxxxxx ("Schering Ltd.").
In this Agreement, Schering Corporation and Schering Ltd. are referred to
collectively as "Schering", Millennium and Schering are referred to individually
as a "Party" and collectively as the "Parties", and references to Millennium and
Schering include their respective Affiliates. All capitalized terms that are
used but not defined in this Agreement have the same meanings as in the
Collaboration Agreement (defined below).
INTRODUCTION
1. Schering Corporation, Schering Ltd. and COR Therapeutics, Inc., a
Delaware corporation having its principal place of business at 000 Xxxx Xxxxx
Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, X.X.X. ("COR") entered into a
Collaboration Agreement dated April 10, 1995, as amended, (the "Collaboration
Agreement"). The Collaboration Agreement provided Schering the opportunity to
participate in the development and commercialization of INTEGRILIN(R)
(eptifibatide) Injection ("INTEGRILIN"), a small peptide pharmaceutical that COR
had discovered and was developing.
2. On February 12, 2002, Millennium acquired COR by merger, succeeding
COR in the Collaboration Agreement.
3. The Parties wish to terminate Schering's role in the
commercialization and manufacturing of INTEGRILIN in and for the Transferring
Territory, and to have Schering's existing regulatory approvals and
authorizations, contractual rights and responsibilities transferred in an
appropriate manner to a new commercial licensee that Millennium will identify.
4. Therefore, Millennium and Schering make the following agreement,
which amends and supplements the Collaboration Agreement.
ARTICLE I
DEFINITIONS
Except as otherwise expressly defined in this Agreement, all capitalized terms
used herein shall have the meanings set forth in the Collaboration Agreement.
The following capitalized terms as used in this Agreement, whether in the
singular or plural, shall have the meanings set forth below:
Section 1.1 "Affiliates" means, except as provided below, an entity that,
directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with Millennium, Schering or the New
Commercial Licensee, as applicable. The Parties recognize that in certain
countries an Affiliate may not be majority-owned by Millennium, Schering or the
New Commercial Licensee.
Section 1.2 "Central Marketing Authorization" means the regulatory approval
for the Licensed Product that is filed through the centralized procedure for the
European Union and approved by the European Commission.
Section 1.3 "Closing Date" means the effective date of the New Commercial
Agreement between Millennium and its New Commercial Licensee.
Section 1.4 "Commercialization" or "Commercialize" means the performance of
activities directed to obtaining pricing and reimbursement approvals, marketing,
promoting, distributing, importing or selling a pharmaceutical product; PROVIDED
that Commercialization shall not include any activities which constitute
Manufacturing.
Section 1.5 "Country Approval Notice" shall have the meaning set forth in
Section 5.5.
Section 1.6 "Development" or "Develop" means the performance of
non-clinical and clinical research and drug development activities related to
obtaining and maintaining Regulatory Approval for pharmaceutical products,
including without limitation toxicology, pharmacology and other discovery
efforts, test method development and stability testing, process development,
formulation development, delivery system development, quality assurance and
quality control development, statistical analysis, clinical studies (including
pre- and post-approval studies and investigator sponsored clinical studies),
regulatory affairs, and Regulatory Approval and clinical study regulatory
activities (excluding regulatory activities directed to obtaining pricing and
reimbursement approvals).
Section 1.7 "Final Approval Notice" shall have the meaning set forth in
Section 11.10(d).
Section 1.8 "Interim Period" shall have the meaning set forth in Section
2.6.
Section 1.9 "Liabilities" means any claims, suits, liabilities, debts,
losses, damages, demands, judgments or awards arising from or connected with the
Development, Manufacture or Commercialization of INTEGRILIN Products in or for
the Transferring Territory, including without limitation, those related to (i)
Development activities in or for the Transferring Territory utilizing INTEGRILIN
Products; (ii) products liability claims; (iii) claims of patent or trademark
infringement; or (iv) Commercialization activities in the Transferring Territory
related to INTEGRILIN Products.
Section 1.10 "Manufacturing" or "Manufacture" means all the activities
relating to production of each Product, spanning from purchasing raw materials
to final packaging of Product for distribution and sale in the Transferring
Territory on a country-by-country basis, including without limitation purchasing
raw materials, production, quality control and assurance, filling, labeling,
packaging and finishing, release, holding and storage and the tests and analyses
conducted in connection therewith.
Section 1.11 "Marks" shall mean any trademarks, service marks, trade names
and logos (excluding the Trademarks) that are owned by Schering or Millennium
and are used in connection with the Development or Commercialization of
INTEGRILIN Products in the Transferring Territory.
Section 1.12 "Negotiation Period" means the period beginning on the
Effective Date and ending on the first to occur of [**].
Section 1.13 "New Commercial Licensee" means Glaxo Group Ltd. or another
Pharmaceutical Company selected by Millennium to enter into the New Commercial
Agreement.
Section 1.14 "New Commercial Agreement" means a definitive agreement
between Millennium and a Pharmaceutical Company under which such Pharmaceutical
Company is granted a license to INTEGRILIN Products and assumes primary
responsibility for (i) the Development and Commercialization of the INTEGRILIN
Products in and for the Transferring Territory, and (ii) the Manufacture of the
INTEGRILIN Products for Development and Commercialization in the Transferring
Territory (or agrees to enter into a contract with Millennium for performance of
certain aspects of such Manufacturing).
Section 1.15 "Pharmaceutical Company" means a company (other than
Millennium or Schering or any of their respective Affiliates) which has
resources for and experience in the Development and Commercialization of
proprietary pharmaceutical products for the treatment of cardiovascular disease
in the major markets of the Transferring Territory.
Section 1.16 "Regulatory Authority" means any federal, national,
multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity with authority over manufacture, pricing,
reimbursement, marketing and sale of pharmaceutical products in one or more
countries in the Transferring Territory.
Section 1.17 "Reporting Agreement" means the agreement to be entered into
by the Parties and the New Commercial Licensee with respect to the exchange and
reporting of safety data and information related to the INTEGRILIN Products.
Section 1.18 "Trademark" means all registrations, applications for
registration and other rights in and to the "INTEGRILIN" xxxx [**] for the
Development, Manufacture and Commercialization of INTEGRILIN Products in or for
the Transferring Territory.
Section 1.19 "Transfer(s)" shall mean, with respect to the Regulatory
Approvals for INTEGRILIN Products in a given country in the Transferring
Territory, (i) the submission by Schering of all documentation necessary for,
and the receipt by Millennium or the New Commercial Licensee of all necessary
approvals from Regulatory Authorities in such country for, the assignment and
transfer to Millennium or the New Commercial Licensee of all Regulatory
Approvals held by Schering for the Commercialization of INTEGRILIN Products in
such country, and that such assignment and transfer is valid and effective and
(ii) the transfer by Schering to Millennium or its designees of all
documentation necessary to enable Millennium or its designees to Manufacture
INTEGRILIN Products for distribution and sale in the Transferring Territory.
Section 1.20 "Transferring Territory" means all of the following countries:
[**] and any other countries that may arise by succession, subdivision,
consolidation or reconstitution of these countries.
Section 1.21 "Transition Period" means a period [**] beginning on the
Closing Date, including as such period may be extended pursuant to Section 3.5.
Section 1.22 Additional Definitions. Each of the following definitions is
set forth in the Section of this Agreement indicated below:
DEFINITION SECTION
---------- -------
AAA 12.3(b)
Acceptance Notice 11.10(c)
ADR 12.3(b)
Annual Sales Threshold 9.2(a)
Arbitrators 12.3(b)
Assignable Contracts 8.1(b)
Carry-Forward Liabilities 11.3
Collaboration Agreement Introduction
Competing Product 10.1(a)
COR Introduction
Effective Date Preamble
Excluded Liabilities 11.4
Existing Inventory 5.3(c)
Field 10.1(a)
Final Approval Notice 11.10(d)
Global AE Database 3.3
INTEGRILIN Introduction
JSC 2.5(a)
Key Countries 5.2(a)(vi)
Losses 11.5
Manufacturing Agreement 11.10(a)(i)
Marketing Materials 4.3
Millennium Preamble
Non-Schering Indemnified Parties 11.5
Ongoing Development Activities 7.1
Party (ies) Preamble
Post-Transfer Liabilities 11.3
Pre-Closing Liabilities 11.1
Released Party 11.10(a)(i)
Releasing Party 11.10(a)(i)
Schering Preamble
Schering Corporation Preamble
Schering Indemnified Parties 11.6
Schering Ltd. Preamble
Shortfall Notice 11.10(c)
SP-Royalty Sales 9.2(a)
Transition Liabilities 11.2
ARTICLE II
IDENTIFICATION OF A NEW COMMERCIAL LICENSEE
Section 2.1 Millennium's Identification of a New Commercial Licensee.
Millennium shall use commercially reasonable efforts during the Negotiation
Period to identify a Pharmaceutical Company reasonably acceptable to Millennium
to negotiate, execute and enter into a New Commercial Agreement. Generally, the
Parties intend for Millennium to enter into a New Commercial Agreement and for
Schering to complete the Transfer of all of the Regulatory Approvals for
INTEGRILIN Products in and for the Transferring Territory to the New Commercial
Licensee on or before [**] or as soon as practicable thereafter considering
regulatory review periods.
Section 2.2 Schering's Cooperation.
(a) During the Negotiation Period, Schering shall, upon
request by Millennium use commercially reasonable efforts to promptly provide
reasonable assistance to Millennium to facilitate the identification of a New
Commercial Licensee, and to enable Millennium to complete and enter into and to
facilitate performance of a New Commercial Agreement. This assistance may
include, without limitation, providing Millennium and each bona fide potential
New Commercial Licensee and the actual New Commercial Licensee with reasonable
access to all information, documents, records, personnel, contractors, agents
and facilities reasonably necessary in order to complete a reasonable due
diligence review of the Development, Manufacture and Commercialization of
INTEGRILIN Products in or for the Transferring Territory, including without
limitation the following:
(i) documents and records related to the Development, Manufacture and
Commercialization of INTEGRILIN Products in or for the Transferring
Territory, including without limitation:
(A) documents and records related to Regulatory Approvals and
any withdrawals or rejections of applications for Regulatory
Approvals;
(B) documents (and conversation logs) of communications with
governmental or regulatory authorities;
(C) [**]; and
(D) Patent and Trademark registrations in the Transferring
Territory;
(ii) Schering personnel and contractors (if any) responsible for the
Development, Manufacture and Commercialization of INTEGRILIN
Products in or for the Transferring Territory; and
(iii) manufacturing facilities owned or operated by Schering (or its
subcontractors, if any) which will be used for the Manufacture
and supply of INTEGRILIN Products during the Negotiation Period
and/or the Transition Period (if any).
Any copies of documents and records to be provided by Schering pursuant to this
Section 2.2(a) shall be provided in a timely manner consistent with the time
periods required by Section 5.2(c). Schering shall provide written notice to
Millennium when it has completed all of the activities noted in the obligations
as set forth in this Section 2.2(a).
(b) Schering's obligation to provide assistance under
this Section 2.2 is conditioned upon Millennium's ensuring that the potential
New Commercial Licensee is obligated in writing to treat all such information
and documents as confidential, not to disclose such information to any Third
Party (other than its agents or advisors who are bound by similar
confidentiality obligations), and not to use such information and documents for
any purpose other than evaluating its interest in entering into a New Commercial
Agreement.
(c) To the extent that [**] in connection with providing
any assistance first requested by [**] after the Effective Date pursuant to
Section 2.2(a), [**] up to an aggregate total of [**]. [**] any documented [**]
reasonably incurred [**] after the Effective Date pursuant to Section 2.2(a) in
providing assistance requested by [**] pursuant to Section 2.2(a) [**]. In
addition, [**] for providing up to an aggregate total of [**] in connection with
providing assistance pursuant to Section 2.2(a), and [**] any pre-approved and
documented [**] in providing such assistance [**]. Any access to Schering's or
its subcontractors' facilities shall be during normal business hours at such
times and places as are mutually agreed by the Parties.
Section 2.3 Confidentiality.
All information about the existence of discussions with any potential New
Commercial Licensee, including the status of negotiations and the potential
terms of any New Commercial Agreement, as well as any other information and
materials received by Schering from any potential New Commercial Licensee
(whether directly or through Millennium or some other intermediary) in
connection with the activities performed by Schering pursuant to Section 2.2,
shall be treated as Confidential Information of Millennium under Section 13.1 of
the Collaboration Agreement.
Section 2.4 Schering's Diligence Obligations during the Negotiation Period.
(a) All of Schering's existing obligations under the
Collaboration Agreement applicable to the Transferring Territory, including
diligence, compliance and regulatory reporting responsibility, shall continue
in full force and effect during the Negotiation Period unless specifically
modified or terminated by a provision in this Agreement. For purposes of clarity
and avoidance of doubt, Schering acknowledges that its existing diligence
obligations under the Collaboration Agreement as applied during the Negotiation
Period shall include, without limitation, applying Diligent Efforts or
commercially reasonable efforts (as applicable in the relevant country in the
Transferring Territory) to accept and fulfill all bids, tenders and orders for
INTEGRILIN Products in such country and to supply INTEGRILIN Products in
accordance with such bids, tenders and orders. In addition, Schering agrees that
during the Negotiation Period its efforts with regard to the Development and
Commercialization of INTEGRILIN Products in the Transferring Territory during
the Negotiation Period shall be maintained at least at a level commensurate with
such efforts during the one year period immediately preceding the Effective
Date. For the avoidance of doubt, the required performance obligation of
Schering related to [**] Europe is in no way modified by this provision or any
other provision of this Agreement.
(b) During the Negotiation Period, Schering shall perform its
existing obligations under the Collaboration Agreement with respect to the
Manufacture of INTEGRILIN Products for the Transferring Territory, including
continuing to provide prompt and reasonable assistance to Millennium to help
ensure that there is a continuous supply of INTEGRILIN Products in and for the
Transferring Territory. Schering's obligations under this Section 2.4(b) will
include, upon request, reasonably cooperating with Millennium's or its
designee's efforts to establish Third Party contractors for the Manufacture of
INTEGRILIN Products for the Transferring Territory. Schering shall also ensure
that it consults and cooperates with Millennium in obtaining Regulatory
Approvals and provides Millennium with copies of all written regulatory reports
related to INTEGRILIN Products that are submitted to Regulatory Authorities in
the Transferring Territory within two (2) days of submission.
Section 2.5 Decision Making During the Negotiation Period.
(a) During the Negotiation Period, the allocation of
responsibilities between the Parties, and related decision making authority,
with respect to the Development, Manufacture and Commercialization of INTEGRILIN
Products in and for the Transferring Territory shall continue to be governed by
the terms and conditions of the Collaboration Agreement. In particular, those
provisions governing the responsibilities and decision making powers of the
Joint Strategic Committee ("JSC") established by the Parties under Article 2
of the Collaboration Agreement shall remain in full force and effect.
(b) The Parties will ensure that during the Negotiation Period
all activities related to obtaining and maintaining Regulatory Approvals for
INTEGRILIN Products in the Transferring Territory are performed in accordance
with the terms and conditions of Article 3 of the Collaboration Agreement. In
particular, the Parties shall continue to consult and cooperate in the
preparation of each Drug Approval Application and in obtaining Regulatory
Approvals in the Transferring Territory, as required under Section 3.4(a) of the
Collaboration Agreement.
Section 2.6 Effect of Failure to Close During the Negotiation Period.
In the event that Millennium and the New Commercial Licensee fail to close
the New Commercial Agreement prior to [**], then the following terms shall
govern during the period of time beginning on the expiration of the Negotiation
Period and ending on the earlier of [**] the Negotiation Period (the "Interim
Period"):
(a) Schering's diligence obligations with respect to
Development and Commercialization of INTEGRILIN Products in and for the
Transferring Territory as set forth in Sections 3.2(a) and 5.6 of the
Collaboration Agreement [**] during the Interim Period such that Schering [**]
in any country in the Transferring Territory and [**] to Develop and
Commercialize the INTEGRILIN Products in the Transferring Territory.
(b) Schering shall, upon request [**], continue to promptly and
reasonably cooperate with Millennium, as provided under Section 2.2 of this
Agreement, to identify a New Commercial Licensee and to complete and enter into
and to facilitate performance of a New Commercial Agreement. In the event that
Millennium has not entered into a New Commercial Agreement having a Closing Date
[**], then Schering's obligations under Section 2.2 to assist Millennium to
identify a New Commercial Licensee and enter into a New Commercial Agreement
[**].
(c) Upon expiration of the Interim Period [**] ([**] at any
time during the Negotiation Period or the Interim Period), the Parties shall
promptly arrange for the [**] with respect to [**] INTEGRILIN Products [**] of
this Agreement [**]. The Parties shall use commercially reasonable efforts to
complete [**] as soon as practicable, and in any event within [**]. Such [**]
period for completion [**] shall be extended if, and only to the extent
necessary, due to delays arising from or otherwise directly attributable to
governmental or Regulatory Authorities or processes solely in order to achieve
[**] the Effective Date, such that all Regulatory Approvals, [**], are valid and
effective [**]. The [**] period may also be extended if necessary [**], provided
that such extension shall not exceed [**]. Commercially reasonable efforts [**]
under this Section 2.6(c) shall include, without limitation, promptly performing
any actions reasonably necessary [**] all Regulatory Approvals existing as of
the Effective Date [**] pursuant to this Section 2.6(c) in order to ensure that
[**] will be completed [**] provided for in this Section 2.6(c).
ARTICLE III
MANAGEMENT DURING THE TRANSITION PERIOD
Section 3.1 Notification of Closing.
Millennium shall notify Schering in writing on or promptly after the
Closing Date that the New Commercial Agreement has been executed and is in full
force and effect. Such notice shall identify the New Commercial Licensee and
provide all necessary contact information for the New Commercial Licensee to
enable Schering to communicate with the New Commercial Licensee in order to
fulfill its obligations under this Agreement. Within five (5) Business Days
after such notice, Schering shall provide all necessary contact information to
enable Millennium and the New Commercial Licensee to communicate with Schering
in order to accomplish the transfers described in this Agreement, including
without limitation a designated representative for:
(a) manufacturing matters for the Transferring Territory;
(b) regulatory matters for the Transferring Territory;
(c) operational matters for the Transferring Territory; and
(d) each country in the Transferring Territory.
Section 3.2 General Principles of Management.
During the Transition Period, the allocation of responsibilities between
the Parties, and related decision making authority, with respect to the
Development, Manufacture and Commercialization of INTEGRILIN Products in and for
the Transferring Territory as set forth in the Collaboration Agreement shall be
amended as follows:
(a) notwithstanding the provisions of Section 2.5 of the
Collaboration Agreement, Millennium shall have final decision making authority
with respect to any disagreement at the JSC with regard to any matter concerning
the Development, Manufacture or Commercialization of INTEGRILIN Products in the
Transferring Territory;
(b) [**] the Lead Marketing Party under Section 5.3 of the
Collaboration Agreement for the INTEGRILIN Products in the Transferring
Territory; and
(c) Schering shall consult with Millennium and obtain
Millennium's prior approval with respect to any activities related to obtaining
and maintaining Regulatory Approvals for the INTEGRILIN Products in the
Transferring Territory, including without limitation any communications with
and/or submissions to Regulatory Authorities in the Transferring Territory.
During the Transition Period, representatives of Millennium and/or the New
Commercial Licensee shall have the right to be present and participate in any
meetings or discussions with regulatory agencies or authorities related to the
Regulatory Approvals for the INTEGRILIN Products in the Transferring Territory.
(d) Schering shall consult with Millennium or New Commercial
Licensee, as applicable, and obtain prior approval with respect to [**] relating
to INTEGRILIN Products for use in the Transferring Territory. To facilitate
co-promotion by New Commercial Licensee as set forth in Section 8.1 hereof, New
Commercial Licensee will consult with Schering and obtain prior approval with
respect to [**] relating to INTEGRILIN Products. Such approval shall not be
unreasonably withheld and shall be provided within ten (10) business days of
receipt of such materials from New Commercial Licensee. New Commercial Licensee
shall forward all such materials to an individual to be identified by Schering
within ten (10) business days of the Effective Date. New Commercial Licensee
will have the right to use such materials [**], in accordance with the terms of
the applicable Regulatory Approvals and applicable Laws.
Section 3.3 Adverse Event and Product Complaint Reporting Procedures;
Notice of Information Affecting Marketability of the Product.
Upon or as soon as is practicable, but no later than thirty (30) days
following the Closing Date, the Parties shall in good faith negotiate and enter
into a Reporting Agreement with the New Commercial Licensee. The Reporting
Agreement shall include provisions setting forth the Parties' and the New
Commercial Licensee's responsibilities for the exchange and reporting of
information related to adverse events and other product safety data for the
INTEGRILIN Products, and shall transfer to Millennium the responsibility for
maintaining the unified global adverse event database for INTEGRILIN Products,
as described in Section 10.1 of the Collaboration Agreement (the "Global AE
Database"). Until the effectiveness of the Reporting Agreement, Schering and
Millennium shall continue to fulfill their respective obligations with respect
to the maintenance of the Global AE Database, and with respect to the exchange
and reporting of product quality complaints, adverse events and product safety
data related to INTEGRILIN Products in the same manner as is being followed by
the Parties prior to the Effective Date; provided, however:
(i) During and after the Transition Period, each Party
shall promptly notify the other Party and the New Commercial Licensee, and
Millennium shall require the New Commercial Licensee to promptly notify
Schering, if it becomes aware of any product safety related information or
circumstance that is likely to have a material adverse effect on the
Development, Commercialization or Manufacture of INTEGRILIN Products; and
(ii) For as long as Schering is responsible for
maintaining the Global AE Database, Schering shall generate adverse event
reports as necessary for Millennium's and, as applicable, the New Commercial
Licensee's use in the Transferring Territory, and Millennium (and, effective as
of the effective date of the Reporting Agreement, the New Commercial Licensee)
shall have access to the adverse event and safety data related to INTEGRILIN
Products contained in the Global AE Database. Following the transfer to
Millennium of responsibility for maintaining the Global AE Database pursuant to
the Reporting Agreement, Millennium shall generate adverse event reports as
necessary for Schering's use pursuant to the Collaboration Agreement and
Schering shall have access to the adverse event and safety data related to
INTEGRILIN Products contained in the Global AE Database.
Section 3.4 Schering's Diligence Obligations during the Transition Period.
(a) All of Schering's existing obligations under the
Collaboration Agreement applicable to the Transferring Territory, including
diligence, compliance and regulatory reporting responsibility, shall continue
during the Transition Period unless specifically modified or terminated by a
provision in this Agreement. Schering agrees that during the Transition Period
(i) until Schering's receipt of an applicable Country Approval Notice of
Transfer of Regulatory Approvals for Commercialization of INTEGRILIN), it shall
use Diligent Efforts or commercially reasonable efforts (as applicable in the
relevant country in the Transferring Territory) to maintain [**] INTEGRILIN
Products for such country consistent with [**], accept and fulfill all [**]
orders and will [**] agreements [**] as of the Effective Date for INTEGRILIN
Products for such country in the Transferring Territory, (ii) its efforts with
regard to the Development and Commercialization of INTEGRILIN Products in the
Transferring Territory shall be maintained at least at a level commensurate with
such efforts [**] immediately preceding the Effective Date, and (iii) it shall
use commercially reasonable efforts to comply with the reasonable requests of
Millennium and New Commercial Licensee as necessary to facilitate the
establishment by New Commercial Licensee of requisite operational capability in
connection with the Transfers and Commercialization.
(b) During the Transition Period, Schering shall, upon request,
reasonably cooperate with Millennium efforts to establish Third Party
contractors for the Manufacture of INTEGRILIN Products for the Transferring
Territory.
Section 3.5 Extension of the Transition Period.
The term of the Transition Period shall be extended if, and only to the
extent necessary, due to delays arising from or otherwise directly attributable
to governmental or Regulatory Authorities or processes solely in order to
achieve the Transfer of all Regulatory Approvals such that all Regulatory
Approvals, [**], are valid and effective in all of the countries in the
Transferring Territory. The term of the Transition Period may also be extended
by Millennium or New Commercial Licensee if necessary to permit the
establishment by Millennium or New Commercial Licensee [**] the INTEGRILIN
Products, provided that such extension shall [**] following completion of all
necessary and relevant Transfers.
ARTICLE IV
INTELLECTUAL PROPERTY LICENSES AND MANAGEMENT
Section 4.1 Termination of IP Licenses Granted to Schering.
Effective on a country-by-country basis upon the earlier of: (a) Schering's
receipt of Final Approval Notice from Millennium pursuant to Section 11.10(d) of
this Agreement; or (b) Schering's receipt of Country Approval Notice with
respect to Commercializing INTEGRILIN Products in one or more specified
countries in the Transferring Territory, the licenses and other rights granted
in Sections 11.1, 11.4 and 12.10 of the Collaboration Agreement are hereby
amended as follows:
(i) the exclusive license under Millennium Patents to develop
INTEGRILIN Products in the relevant country or countries or in
the Transferring Territory, as applicable, shall terminate;
(ii) the exclusive license under the Millennium Patents to use,
sell, offer for sale, have sold and import Co-Developed
Products in the relevant country or countries or in the
Transferring Territory, as applicable, shall terminate;
(iii) the exclusive license under the Millennium Patents to use,
sell, offer for sale, have sold and import Royalty-Bearing
Products in the relevant country or countries or in the
Transferring Territory, as applicable, shall terminate;
(iv) the non-exclusive license under the Millennium Patents to
make and have made INTEGRILIN Products in or for the relevant
country or countries or in or for the Transferring Territory,
as applicable, shall terminate except to the extent necessary
(1) to permit Schering or its designated Affiliates to perform
its Manufacturing obligations under this Agreement, and/or (2)
to permit Schering or its designated Affiliates to make or
have made INTEGRILIN Products at facilities located in the
Transferring Territory solely for distribution, use and/or
sale by or on behalf of Schering, its Affiliates or permitted
sublicensees pursuant to the Collaboration Agreement in any
and all countries that are outside the Transferring Territory;
(v) the non-exclusive license to use Millennium Know-how shall
terminate with respect to (1) use of the Millennium Know-how
to Develop and Commercialize INTEGRILIN Products in the
relevant country or countries or in the Transferring
Territory, as applicable, and (2) use of the Millennium
Know-how to Manufacture INTEGRILIN Products in or for the
relevant country or countries or in or for the Transferring
Territory, as applicable, except in each case to the extent
necessary to enable Schering to exercise those licenses
retained by Schering under Section 4.1(iv) with respect to
Manufacture of INTEGRILIN Products for distribution, use
and/or sale outside the Transferring Territory;
(vi) the exclusive license from Millennium to Schering to use the
Trademarks for the sale of INTEGRILIN Products in the relevant
country or countries or in the Transferring Territory, as
applicable, shall terminate; and
(vii) the limited rights of use granted by each of Schering and
Millennium with respect to their relevant Marks in the
relevant country or in the Transferring Territory, as
applicable, shall terminate; provided that the specific rights
granted in Section 4.3 hereof shall not be affected by such
termination.
Except for the termination of the specific licenses and rights of use provided
for above, all of the remaining licenses and rights of use granted to Schering
under the Collaboration Agreement shall remain in full force and effect. In
addition, notwithstanding the termination of such licenses and rights of use, if
and solely to the extent that the performance by Schering of one or more of its
obligations under this Agreement during the Transition Period [**] as provided
in Section 2.6(c), or pursuant to Section 5.6, requires the continuation of such
terminated licenses or rights of use, such terminated license and/or rights of
use shall be deemed to have remained in effect only for so long as, and solely
to the extent, necessary to enable Schering to perform such obligations.
Section 4.2 Modification of IP Licenses Granted to Millennium.
(a) Effective on a country-by-country basis upon the earlier
of: (1) Schering's receipt of Final Approval Notice from Millennium pursuant to
Section 11.10(d) of this Agreement; or (2) Schering's receipt of Country
Approval Notice with respect to Commercializing INTEGRILIN Products in one or
more specified countries in the Transferring Territory:
(i) the exclusive licenses under the Schering Patents granted by
Schering to Millennium under Section 11.2 of the Collaboration
Agreement shall be exclusive even as to Schering solely with
respect to Commercializing INTEGRILIN Products in the relevant
country or countries or in the Transferring Territory, as
applicable;
(ii) the non-exclusive licenses under the Schering Patents granted
by Schering to Millennium under Section 11.2 of the
Collaboration Agreement with respect to the Manufacture of
INTEGRILIN Products shall be exclusive (except as to Schering
and its Affiliates) with respect to the Manufacture of
INTEGRILIN Products for distribution, use and/or sale in the
relevant country or countries or in the Transferring
Territory, as applicable; PROVIDED, HOWEVER, that upon
Schering's receipt of the applicable Country Approval Notice
from Millennium pursuant to Section 5.5 of this Agreement or
Final Approval Notice pursuant to Section 11.10(d) (whichever
occurs first), the rights to Manufacture INTEGRILIN Products
in the Transferring Territory retained by Schering shall be
limited to permit Schering or its designated Affiliates to
make or have made INTEGRILIN Products at facilities located in
the Transferring Territory solely for distribution, use and/or
sale by or on behalf of Schering, its Affiliates or permitted
sublicensees pursuant to the Collaboration Agreement in
countries that are outside the Transferring Territory;
(iii) the non-exclusive licenses to use the Schering Know-how
granted by Schering to Millennium under Section 11.5 of the
Collaboration Agreement shall be exclusive even as to Schering
solely with respect to Commercializing INTEGRILIN Products in
the relevant country or countries or in the Transferring
Territory, as applicable; and
(iv) the non-exclusive licenses to use the Schering Know-how
granted by Schering to Millennium under Section 11.5 of the
Collaboration Agreement with respect to Manufacturing
INTEGRILIN Products shall be exclusive (except as to Schering)
solely with respect to Manufacturing INTEGRILIN Products in or
for the relevant country or countries or in or for the
Transferring Territory, as applicable; PROVIDED, HOWEVER, upon
Schering's receipt of the Country Approval Notice from
Millennium pursuant to Section 5.5 of this Agreement or Final
Approval Notice pursuant to Section 11.10(d) (whichever occurs
first), the rights to Manufacture INTEGRILIN Products in the
Transferring Territory retained by Schering shall be limited
to enabling Schering or its designated Affiliates to perform
its Manufacturing obligations under this Agreement, and/or to
permit Schering or its designated Affiliates to make or have
made INTEGRILIN Products at facilities located in the
Transferring Territory solely for distribution, use and/or
sale by or on behalf of Schering, its Affiliates or permitted
sublicensees pursuant to the Collaboration Agreement in
countries that are outside the Transferring Territory.
(b) The licenses described in Sections 4.2(a) shall be
sublicensable by Millennium.
(c) Schering shall, upon request, promptly make available to
Millennium all Schering Know-how for which a license to Millennium is granted or
continued under Section 4.2(a) of this Agreement or under the Collaboration
Agreement.
(d) The licenses to use Schering Know-how described in Sections
4.2(a)(iii) and 4.2(a)(iv) shall continue in effect for a period of ten (10)
years from the Effective Date. At any time prior to or upon the conclusion of
such ten-year period, Millennium may elect to extend these licenses for an
additional ten (10) year period by written notice to Schering accompanied with
payment of a [**] dollar ($[**]) license extension fee. Effective on the 20th
anniversary of the Effective Date (or the 10th anniversary of the Effective Date
if Millennium does not extend such licenses), such licenses shall convert to
non-exclusive, perpetual licenses.
Section 4.3 Certain Copyrights and Trademarks.
Effective as of the first to occur of: (a) the Closing Date; (b) [**]; or
(c) [**] described in Section 2.6(c) of this Agreement, Schering grants to
Millennium and the New Commercial Licensee an exclusive, perpetual,
royalty-free, sublicensable license under Schering's copyrights in all Marketing
Materials solely for use in Commercializing INTEGRILIN Products in the
Transferring Territory in accordance with Regulatory Approvals and applicable
Laws; provided, however that on a country-by-country basis until the earlier of
the relevant Country Approval Notice, Final Approval Notice or the expiration of
the Transition Period, such license shall be solely for use of the Marketing
Materials pursuant to and in accordance with Sections 8.1 and 3.2(d). The term
"Marketing Materials" shall mean all product specific promotional materials,
educational materials, product labeling, product inserts and product packaging
used by Schering or approved by Schering pursuant to Section 3.2(d) in
Commercializing INTEGRILIN Products in the Transferring Territory, including all
of Schering's sales force training materials specific for INTEGRILIN. For
purposes of clarity, the Parties acknowledge that the copyright license granted
under this Section 4.3 includes the non-exclusive, non-sublicensable limited
right to use any of Schering's Marks only if and to the extent the Marketing
Materials display such Marks and solely for internal use by Millennium and the
New Commercial Licensee and/or as necessary to co-promote the INTEGRILIN
Products under Section 8.1. No other right or license to use any of Schering's
Marks is granted or conveyed hereunder, either expressly or by implication.
Section 4.4 Scope of Schering Activities.
This Section 4.4 shall be effective as of the first to occur of: (a) notice
that New Commercial Licensee will fill orders for INTEGRILIN Products directly,
such notice to be issued on a country-by-country basis no later than the earlier
of the date of the relevant Country Approval Notice or Final Approval Notice;
(b) [**]; or (c) [**] described in Section 2.6(c) of this Agreement. Except as
expressly provided in this Agreement, during such time and in such jurisdictions
where there are Patents within Millennium's Control covering INTEGRILIN Product,
Schering shall not actively solicit orders from any prospective purchaser for
the Transferring Territory, nor accept nor fulfill orders derived for the
Transferring Territory, nor deliver or tender (or cause to be delivered or
tendered) any INTEGRILIN Product to any purchaser in the Transferring Territory.
If Schering receives any order from a prospective purchaser in the Transferring
Territory, whether solicited or not, Schering shall promptly refer that order to
the New Commercial Licensee. Schering shall not sell INTEGRILIN Products to a
purchaser if, at the time of such sale, Schering knows or has reason to believe
that such purchaser intends to export those INTEGRILIN Products into the
Transferring Territory, but shall promptly refer such purchaser to the New
Commercial Licensee or Millennium.
Section 4.5 Management of Certain Intellectual Property.
(a) Each of Schering and Millennium shall continue to be
responsible for the prosecution and maintenance of Patents on or after the
Closing Date for which it was responsible under Article 12 of the Collaboration
Agreement prior to the Closing Date. For clarity, the provisions of Section 12.2
and 12.4 (as applicable) of the Collaboration Agreement shall not apply if, on
or after the Closing Date, a Third Party asserts that a patent or other right
owned by it is infringed by the manufacture, use or sale of INTEGRILIN Products
on or after the Closing Date in a country in the Transferring Territory.
Notwithstanding anything in the Collaboration Agreement to the contrary,
effective as of the Closing Date, Millennium shall be solely responsible for any
Patent Costs incurred by it or its Affiliates in connection with the prosecution
and maintenance of Patents in the Transferring Territory and shall not be
entitled to include any such Patent Costs as Allowable Expenses under the
Collaboration Agreement.
(b) Notwithstanding Section 12.10 of the Collaboration
Agreement, as of the first to occur of: (a) the Closing Date; (b) [**]; or (c)
[**] described in Section 2.6(c) of this Agreement, Millennium (and not
Schering) will be responsible for filing and prosecuting the Trademarks in the
Transferring Territory, Millennium shall be deemed to be the prosecuting party
for the Trademarks in the Transferring Territory for purposes of Section 12.11
of the Collaboration Agreement, and Millennium shall be solely responsible for
all costs associated with the Trademarks in the Transferring Territory and
Section 12.12 of the Collaboration Agreement shall not apply. Schering will at
such time promptly transfer to counsel selected by Millennium copies of all
documents, records and files concerning the registration or use of the
Trademarks in the Transferring Territory and shall execute any assignments or
other documents necessary to transfer the Trademarks in the Territory to
Millennium. Schering agrees, upon request, to provide Millennium reasonable
access to Schering's in-house trademark counsel as necessary to address
inquiries relating to past prosecution of the Trademark portfolio.
ARTICLE V
TRANSFER OF RESPONSIBILITIES BY SCHERING
Section 5.1 Transfer of Regulatory Approvals.
(a) Promptly after the Closing Date (and in any event within
five (5) business days after receiving written notice from Millennium under
Section 3.1 of this Agreement) Schering shall provide each of Millennium and the
New Commercial Licensee with appropriate documentation to grant each of them the
right to access and cross-reference any applicable drug master file for the
active pharmaceutical ingredient in the INTEGRILIN Products in each country in
the Transferring Territory where Schering holds a Regulatory Approval, in the
format required by the applicable Regulatory Authority, to enable each of
Millennium and the New Commercial Licensee to perform each of their respective
obligations under the New Commercial Agreement.
(b) During the Transition Period, Schering, Millennium and the
New Commercial Licensee shall coordinate the Transfer of all Regulatory
Approvals of INTEGRILIN Products in the Transferring Territory to the New
Commercial Licensee, including, without limitation, the current [**] for the
Transferring Territory. For purposes of clarity, it is anticipated that meetings
with the Regulatory Authorities pursuant to Section 3.2(c) will include
discussions with, and agreement of, the Regulatory Authorities concerning the
Transfer review process and timing of such review process and approval of the
various filings, and that such meetings will take place ahead of initiating the
Transfer. Each of Schering and Millennium shall use, and Millennium shall
procure that the New Commercial Licensee uses, commercially reasonable efforts
to complete the Transfer of Regulatory Approvals for INTEGRILIN Products in each
country in the Transferring Territory where Schering holds such Regulatory
Approvals as soon as practicable after the Closing Date. The Parties acknowledge
and agree that Millennium or New Commercial Licensee, as applicable, will have
final decision making with regard to the plans, actions, filings and timing
thereof required to complete the Transfer subject to the requirement that such
decisions shall not delay the Marketing Authorization Transfer filings for the
Territory [**] beyond the Closing Date. Commercially reasonable efforts by
Schering pursuant to this Section 5.1(b) shall include, without limitation,
promptly performing any actions reasonably necessary to effect the Transfer of
all Regulatory Approvals existing as of the Effective Date in the Transferring
Territory to Millennium or the New Commercial Licensee pursuant to this 5.1(b)
in order to ensure that the Transfer of such Regulatory Approvals will be
completed during the Transition Period.
(c) Upon written notice from New Commercial Licensee or
Millennium, as applicable, Schering will promptly notify all customers in
writing that New Commercial Licensee will be assuming the marketing rights to
the INTEGRILIN Products in the Transferring Territory. New Commercial Licensee
will [**] prior to Schering sending the notice to customers. Schering will [**]
in connection with such notice.
Section 5.2 Transfer of Documents.
(a) During the Transition Period, Schering shall, in accordance
with Section 5.2(c), arrange for the transfer to Millennium and the New
Commercial Licensee of copies (or if necessary originals) of any and all
information, documents and records which are in Schering's possession related to
the Development, Manufacture and Commercialization of INTEGRILIN Products in or
for the Transferring Territory that are necessary to achieve the Transfer of all
Regulatory Approvals for INTEGRILIN Products in the Transferring Territory,
and/or which were not previously provided to Millennium or the New Commercial
Licensee pursuant to Section 2.2 and are reasonably necessary to enable
Millennium or the New Commercial Licensee to successfully Develop, Manufacture
and Commercialize INTEGRILIN Products in the Transferring Territory. Schering's
obligation under this Section 5.2 shall include, without limitation, the
following:
(i) all governmental or regulatory correspondence (with all
attachments) including the MAA, International Regulatory file
("IRF"), all labeling and CMC variations and assessment
reports, conversation logs, filings and approvals (including
all Regulatory Approvals, all withdrawals or rejections of
applications for Regulatory Approvals and all pricing and
reimbursement approvals) concerning the Development,
Manufacture and/or Commercialization of INTEGRILIN Products in
the Transferring Territory;
(ii) subject to the terms and conditions of Article 6 of this
Agreement, copies of all data, reports and records (including
all pre-clinical and clinical data concerning INTEGRILIN
Products) in Schering's control which are contained in the
health registration dossiers for, or otherwise used in support
of, the Regulatory Approvals for INTEGRILIN Products in the
Transferring Territory;
(iii) with regard to each country within the Transferring Territory,
electronic and paper copies in all official languages of such
country of product labeling, product packaging and product
inserts used by Schering in Commercializing INTEGRILIN
Products in such country, as well as copies of the product
packaging for INTEGRILIN Products in such country;
(iv) [**] in the Transferring Territory [**] pharmaceutical
products, including contact information;
(v) [**] INTEGRILIN Products in the Transferring Territory, [**];
(vi) [**]
(vii) information related to the marketing of the INTEGRILIN
Products in the Key Countries, including, the most recent
marketing plan for the INTEGRILIN Products, customer market
research for the INTEGRILIN Products, sales force training
materials, sales force alignment and sizing information, sales
data related to the launch of the INTEGRILIN Products, and
sales operations plans for each such country, in each case to
the extent that such information was created by Schering or
otherwise is in Schering's possession;
(viii) copies of any other documents or records in Schering's control
which were provided to Schering by Millennium and contain
Confidential Information of Millennium specifically related to
the Development, Manufacture or Commercialization of
INTEGRILIN Products in or for the Transferring Territory; and
(ix) copies of all marketing and promotional materials, as well as
educational materials, used by Schering in the Key Countries
in connection with the INTEGRILIN Products in the twelve
months (12) immediately preceding the Effective Date.
(b) Schering may retain copies and/or originals of all
documents and records described in Section 5.2(a) for archival purposes and,
except for Confidential Information contained in documents and records described
in Section 5.2(a)(viii) and information described in Sections 5.2(a)(v) and
5.2(a)(vi), shall have the right to use the information contained in all such
documents and records in connection with the Development, Manufacture and
Commercialization of INTEGRILIN Products in countries outside the Transferring
Territory under the terms of the Collaboration Agreement.
(c) Schering and Millennium (to the extent Millennium
facilitates the transfer of relevant information and materials between Schering
and New Commercial Licensee) shall each use commercially reasonable efforts to
complete the transfer of documentation pursuant to Section 5.2(a) within fifteen
(15) days after the later of the Closing Date or the date on which Millennium
notifies Schering in writing that the Closing Date has occurred and provides
Schering with the identity and relevant contact information for the New
Commercial Licensee.
(d) Schering shall provide written notice to Millennium when it
has completed all of the activities noted in the obligations as set forth in
Section 5.2.
Section 5.3 Effects of Transfer of Regulatory Approvals.
Except as may be agreed by the Parties with respect to adverse event
reporting under Section 3.3 and except as otherwise expressly provided by this
Agreement, upon the Transfer of all Regulatory Approvals for INTEGRILIN Products
in a given country in the Transferring Territory, Schering shall have no
obligations, responsibility or authority whatsoever under this Agreement or the
Collaboration Agreement for any matters related to obtaining or maintaining
Regulatory Approvals for INTEGRILIN Products in such country, including without
limitation for communications or other interactions with Regulatory Authorities
in such country with respect to INTEGRILIN Products.
Any and all obligations in the Collaboration Agreement or this Agreement
for Schering to use Diligent Efforts, commercially reasonable efforts, or to
otherwise exploit any of the licenses referred to in Section 4.1 of this
Agreement shall terminate on a country by country basis upon Schering's receipt
from Millennium or New Commercial Licensee of the relevant Country Approval
Notice.
(a) During the Transition Period, Schering shall, upon request,
make its personnel and other resources reasonably available to Millennium and
the New Commercial Licensee as necessary to effect an orderly and timely
transfer of all responsibilities and obligations for the Development and
Commercialization of INTEGRILIN Products in or for the Transferring Territory;
(b) During the Transition Period, Schering shall, upon request,
make its personnel and other resources reasonably available to Millennium and
the New Commercial Licensee as necessary to effect an orderly and timely
transfer of all responsibilities and obligations for Manufacturing of INTEGRILIN
Products for the Transferring Territory;
(c) During the Transition Period, Schering (or its designated
Affiliates) shall continue to supply and Manufacture INTEGRILIN Products for
distribution and sale in the Transferring Territory from its existing inventory
of INTEGRILIN Products available for sale in the Transferring Territory as of
the Effective Date (the "Existing Inventory"), subject to notification from
Millennium or New Commercial Licensee pursuant to Section 4.4 hereof. Except for
the packaging, labeling, testing or other Manufacturing related activities
necessary to place the Existing Inventory in proper condition for distribution
and sale in the Transferring Territory during the Transition Period, effective
as of the Effective Date [**] INTEGRILIN Products [**]. Upon notice from
Millennium or New Commercial Licensee pursuant to Section 4.4, and in no event
later than the end of the Transition Period, Schering shall stop filling orders
or otherwise supplying INTEGRILIN Products to customers in the Transferring
Territory. In addition, effective upon receipt of such notice, Schering shall
not be obligated to accept, or otherwise be liable for, any returns of
INTEGRILIN Products previously distributed and sold by Schering in the
Transferring Territory other than returns of damaged or expired product.
Schering's obligations under this Section 5.3(c) shall remain in effect during
the Transition Period to enable Millennium and the New Commercial Licensee (or a
Third Party under subcontract with Millennium or the New Commercial Licensee) to
obtain the necessary Regulatory Approvals for [**] INTEGRILIN Products;
(d) Schering shall continue the cooperation described in
Section 2.2, if and to the extent reasonably requested by Millennium or New
Commercial Licensee, for up to [**] following its receipt of the Final Approval
Notice as set forth in Section 11.10 (d) of this Agreement to enable Millennium
or the New Commercial Licensee to Develop, Manufacture and/or Commercialize the
INTEGRILIN Products in or for the Transferring Territory (provided that such
period shall be extended due to delays caused by or otherwise directly
attributable to the failure of Schering to meet its obligations under this
Agreement). Schering shall reasonably comply with any request by Millennium or
New Commercial Licensee for additional assistance after the expiration of such
[**] period (including as it may be extended) if and to the extent necessary to
enable Millennium and/or the New Commercial Licensee to respond to specific
requests for information related to INTEGRILIN Products from applicable
Regulatory Authorities; and
(e) Schering shall execute all documents and take all such
further actions, whether on behalf of Schering, Millennium or the New Commercial
Licensee, as may be reasonably requested by Millennium in order to enable
Millennium and/or the New Commercial Licensee to Develop, Manufacture and/or
Commercialize the INTEGRILIN Products in the Transferring Territory.
Section 5.4 Costs.
The costs of taking the actions required to Transfer the Regulatory
Approvals in the Transferring Territory pursuant to this Article V, including
the creation and submission of regulatory reports relating to these activities,
whether on behalf of Schering, Millennium or the New Commercial Licensee, shall
be borne by Schering and shall not be treated as Allowable Expenses under the
Collaboration Agreement. However, Schering's obligations under this Section 5.4
shall be subject to the provisions of Section 2.2(c) of this Agreement. In
addition, [**] by this Agreement [**] by this Agreement.
Section 5.5 Country Approval Notice.
Millennium or its New Commercial Licensee shall provide prompt written
notice to Schering when all necessary Regulatory Approvals to Commercialize
and/or Manufacture, as applicable, INTEGRILIN Products in a specified country in
the Transferring Territory have been obtained and are valid and effective
("Country Approval Notice"). Each Country Approval Notice shall clearly indicate
the relevant country or countries and whether such notice applies to either or
both of Commercializing and Manufacturing in each specified country.
Section 5.6 Delay in Transfer of Regulatory Approvals
In the event that the Transfer of one or more Regulatory Approvals existing
in the Transferring Territory as of the Effective Date is not completed in one
or more countries in the Transferring Territory prior to [**] or the period
provided for in Section 2.6(c), as applicable, [**], then the Parties will
continue to commercialize the INTEGRILIN Products in such country(ies) as
provided in Sections 3.2, 3.4(a)(i), 3.4(a)(ii), 5.3(c), and those provisions
together with Sections 9.2 and 11.2 shall remain in effect as if the Transition
Period had not expired, until such time as the Transfer of such Regulatory
Approvals is completed.
ARTICLE VI
CONFIDENTIALITY
Section 6.1 Disclosure of this Agreement.
The existence and terms of this Agreement shall be treated by each Party as
Confidential Information of the other Party under Section 13.1 of the
Collaboration Agreement. The foregoing notwithstanding, the Parties agree that
(i) Millennium may disclose the existence of this Agreement and/or the
non-financial terms of this Agreement to any potential New Commercial Licensee
as necessary or reasonably desirable in connection with the negotiation and
completion of the New Commercial Agreement, and/or to Third Parties as
reasonably necessary in connection with the performance of its obligations under
this Agreement, and (ii) Schering may disclose the existence of this Agreement
and/or the non-financial terms of this Agreement to Third Parties as reasonable
necessary in connection with the performance of its obligations under this
Agreement.
The Parties agree that the first public announcement of this Agreement will
be made by the Parties on or promptly after the Closing Date and will
incorporate the language substantially in the text set forth on EXHIBIT A. The
Parties agree that, following or concurrently with such announcement, Millennium
and the New Commercial Licensee may make additional disclosures related to the
New Commercial Agreement containing all or part of the information set forth in
EXHIBIT A without requiring Schering's consent. Neither Party shall make any
other publication, news release or other public announcement relating to the
execution of this Agreement, or to the performance of the Parties under this
Agreement or the Collaboration Agreement as applied to the Transferring
Territory, without obtaining the other Party's prior written consent. Millennium
may make other publications, news releases or other public announcements
relating to such subjects without Schering's prior consent, provided that,
except as to disclosures to the New Commercial Licensee or its Affiliates, such
publication, news release or other public announcements do not disclose any
Confidential Information, or other non-public information related to such
subjects, that has not been previously publicly disclosed in accordance with the
foregoing.
The foregoing notwithstanding, if either Party is required (as reasonably
determined by its legal counsel) by regulation, law or legal process, including
without limitation by the rules or regulations of the United States Securities
and Exchange Commission or similar regulatory agency in a country other than the
United States or of any stock exchange or Nasdaq, to disclose the existence of
this Agreement and/or any information related to the terms and conditions of
this Agreement, such Party shall provide prior written notice of such intended
disclosure to the other Party, which notice shall include a copy of the proposed
disclosure. Upon receipt of such notice, the other Party shall have a reasonable
period to review and comment on the proposed disclosure (not to exceed five (5)
business days), and the Party required to disclose shall in good faith consider
any changes or modifications to the proposed disclosure requested by the other
Party. In the event that the legal requirements compelling such disclosure will
not reasonably allow for a review period of five (5) business days, the notice
provided by the Party required to disclose shall specify a shorter period for
review (of not less than one (1) business day) necessary under such
circumstances. The Party legally required to disclose shall use commercially
reasonable efforts to obtain confidential treatment (to the extent available) of
the Confidential Information proposed to be disclosed, and shall disclose only
such Confidential Information of the other Party as is required to be disclosed
in order to comply. In addition, either Party may disclose to bona fide
potential investors, lenders and acquirors/acquirees, and to such Party's
consultants and advisors, the existence and terms of this Agreement only if and
to the extent necessary in connection with a proposed equity or debt financing
of such Party, or a proposed acquisition, merger or other similar business
combination, so long as such recipients are bound in writing to maintain the
confidentiality of such information on terms at least as stringent as those set
forth in Section 13.1 of the Collaboration Agreement.
Section 6.2 Disclosure of Other Information.
The Parties agree that Millennium may disclose to any potential New
Commercial Licensee any information and documents within its possession or
control concerning the Development, Commercialization and Manufacture of
INTEGRILIN Products in or for the Transferring Territory, including without
limitation those which contain Millennium and/or Schering Confidential
Information; provided that Millennium has first entered into a confidentiality
agreement with such potential New Commercial Licensee. Any such confidentiality
agreement shall obligate the potential New Commercial Licensee to treat all such
information and documents as confidential, not to disclose the information and
documents to any Third Party (other than its agents or advisors who are bound by
similar confidentiality obligations), and to use the information and documents
solely for the purpose of evaluating its interest in entering into a New
Commercial Agreement. The duration of the confidentiality and non-use
obligations under such confidentiality agreement shall be for a reasonable and
customary period of time (in no case less than a period of five (5) years) to be
agreed upon by Millennium and the potential New Commercial Licensee.
ARTICLE VII
CLINICAL DEVELOPMENT
Section 7.1 Clinical Development During the Negotiation Period.
Schering will provide Millennium with all information reasonably requested
by Millennium regarding any ongoing clinical studies, investigator initiated
studies, observational studies and product safety registries for INTEGRILIN
Products in the Transferring Territory (collectively, the "Ongoing Development
Activities") for Millennium's and New Commercial Licensee's review. Except as
may otherwise be agreed by the Parties in writing, during the Negotiation
Period, Schering shall continue to conduct any Ongoing Development Activities in
accordance with the Collaboration Agreement and the protocols and budgets
approved by the JSC. As of the Effective Date, Schering has notified Millennium
of all Ongoing Development Activities as set forth on EXHIBIT C attached hereto,
has confirmed that there are no other Development activities for INTEGRILIN
Products in the Transferring Territory other than the Ongoing Development
Activities, and has provided to Millennium copies of budgets, protocols, and
other information and documents reasonably necessary for Millennium to assess
and understand the Ongoing Development Activities for purposes of this Article
VII. Schering agrees to continue to keep Millennium fully informed of the
status, progress and results of such Ongoing Development Activities.
Section 7.2 Clinical Development During the Transition Period.
Schering and Millennium shall [**] promptly following the Transfer of
Regulatory Approvals on a country by country basis [**] of the Ongoing
Development Activities in the Transferring Territory. Alternatively, the Parties
may agree [**] in the Transferring Territory, [**].
Section 7.3 Payment by the New Commercial Licensee of Development Costs.
(a) Effective as of the agreement to transfer of all
responsibility for the continued performance of the Ongoing Development
Activities to Millennium or the New Commercial Licensee, as applicable, as set
forth in Section 7.2, Millennium or the New Commercial Licensee, as applicable,
shall assume full responsibility for Schering's share of the financial
responsibility (as determined pursuant to the Collaboration Agreement), in
accordance with the payment schedule and budget set forth under the relevant
development agreements, for all such Ongoing Development Activities in and for
the relevant country in the Transferring Territory, except for (i) those which
the Parties agree to [**] under Section 7.2, and (ii) the [**]. Schering shall
[**] under such development agreements for activities performed [**] to
Millennium or New Commercial Licensee, as applicable, and [**] any Ongoing
Development Activities in accordance with Section 7.2; PROVIDED, HOWEVER, that
Schering's rights and obligations with respect to [**] shall be governed by the
terms and conditions of the Collaboration Agreement, including, without
limitation, [**], as appropriate.
(b) Effective as of the Closing Date, Millennium and the New
Commercial Licensee shall be solely responsible for the costs of any new
clinical studies (including, without limitation, any phase IV studies,
investigator initiated studies, observational studies and product safety
registries) or other Development activities to be undertaken on or after the
Closing Date for INTEGRILIN Products solely in and for the Transferring
Territory. Millennium shall not be entitled to treat any costs or expenses
related to such clinical studies or other Development activities as Allowable
Expenses or Development Costs under the Collaboration Agreement.
(c) If Schering and Millennium intend to undertake one or more
new clinical studies or other JSC approved Development activities in or for
countries outside of the Transferring Territory (including, without limitation,
any global clinical studies), Millennium shall have the right to request that
the JSC agree to expand the scope of such Development activities to include
clinical activities relevant to the Transferring Territory and/or to make the
data and results of such clinical studies and Development activities available
to the New Commercial Licensee for use in the Transferring Territory, including
without limitation, for use to support new or expanded indications or other
labeling changes for INTEGRILIN Products in the Transferring Territory. Schering
and the JSC shall not unreasonably reject any such request by Millennium to
expand the scope of such Development activities, and shall not reject any such
request by Millennium to make the data and results of such clinical studies and
Development activities available to the New Commercial Licensee for use in the
Transferring Territory; provided that [**] Schering and Millennium [**] Schering
and Millennium [**] INTEGRILIN Products [**] in the Transferring Territory. The
New Commercial Licensee shall have no right to access or use the data and
results of any such clinical studies or other Development activities in or for
the Transferring Territory [**], except (i) as specifically necessary to comply
with adverse event reporting obligations in the Transferring Territory, and/or
(ii) to the extent required in order to comply with a specific written request
for such data and results by a regulatory authority in the Transferring
Territory; and PROVIDED, HOWEVER, that such exceptions shall not to be construed
as permitting New Commercial Licensee to use such data and results to support
new or expanded indications or other labeling changes for INTEGRILIN Products in
the Transferring Territory.
(d) Notwithstanding any provision in this Section 7.3 to the
contrary, at any time after the availability of final data and results of
clinical studies and Development activities described in Section 7.3(c) for
which the New Commercial Licensee did not pay, the New Commercial Licensee may
obtain the right to access and use such data and results (including without
limitation to support new or expanded indications or other labeling changes for
INTEGRILIN Products) in the Transferring Territory upon a one-time payment to
Schering and Millennium (to be allocated in accordance with the Collaboration
Agreement and any JSC determinations) by the New Commercial Licensee of [**]% of
the amount that it would have been required to pay under Section 7.3(c), it
being understood [**] by Millennium and Schering.
ARTICLE VIII
TRANSFERS TO NEW COMMERCIAL LICENSEE; EXPENSE SHARING
Section 8.1 Transfers to the New Commercial Licensee.
(a) On or as soon as practicable after the Closing Date (and in
no event more than three (3) months after the Closing Date), Millennium shall in
writing request and Schering shall (as directed by Millennium in such request)
appoint Millennium or the New Commercial Licensee as the exclusive co-promoter
for the marketing and promotion (but not the sale) of INTEGRILIN Products in and
for the Transferring Territory, such co-promotion to be in accordance with the
terms of the appropriate Regulatory Approval and applicable Laws. In accordance
with Section 4.1 hereof, the co-promotion rights of Schering and the appointment
by Schering of the New Commercial Licensee as co-promoter pursuant to this
Section 8.1 will expire on a country-by-country basis on the first to occur of
receipt of either the Country Approval Notice or Final Approval Notice.
(b) During the Negotiation Period, Schering shall identify to
Millennium in writing any and all contracts it has entered into with Third
Parties for the Manufacture or Commercialization of INTEGRILIN Products in one
or more countries in the Transferring Territory that can be reasonably assigned
or transferred to the New Commercial Licensee (the "Assignable Contracts"), and
shall arrange to provide copies of all Assignable Contracts to Millennium. On or
promptly after the Closing Date, Millennium or the New Commercial Licensee shall
notify Schering in writing of those Assignable Contracts which Millennium or the
New Commercial Licensee wishes Schering to assign. Schering shall promptly
thereafter assign to Millennium or the New Commercial Licensee, and Millennium
or the New Commercial Licensee shall assume all of Schering's rights and
obligations under, all of the Assignable Contracts so identified.
(c) On or promptly after the Closing Date, Schering shall
provide Millennium with a brief summary of any contracts other than Assignable
Contracts that it has entered into with Third Parties for the Manufacture,
distribution, marketing, promotion and/or sale of INTEGRILIN Products in one or
more countries in the Transferring Territory. Such summary shall provide a brief
description of the nature of the services related to INTEGRILIN Products being
provided under the contract. In addition, with respect to any such contracts
related to the purchase and sale of INTEGRILIN Products in the Transferring
Territory, Schering shall, upon request, provide a summary of any provisions
relating to [**] as they relate to INTEGRILIN Products. Upon receipt of written
notice from Millennium or New Commercial Licensee, as applicable, Schering shall
promptly terminate all of its Third Party contracts that are not Assignable
Contracts, or shall amend such Third Party contracts so that they no longer
relate to INTEGRILIN Products in the Transferring Territory. Any Liabilities
arising in connection with the performance, amendment or termination of such
Third Party contracts, including, but not limited to, termination or
modification fees, shall be treated as Carry-Forward Liabilities.
Section 8.2 Manufacturing Expense Sharing.
Prior to the Effective Date, the Parties have agreed to undertake certain
activities to support the manufacture of INTEGRILIN Products for the
Transferring Territory, for which Schering shall reimburse Millennium, including
but not limited to activities [**]. The Parties agree to share costs arising
from such activities as determined by the Joint Steering Committee.
ARTICLE IX
FINANCIAL PROVISIONS
Section 9.1 Payment.
(a) Subject to Section 9.1(b), Millennium shall make one (1)
license fee payment of [**] dollars (USD $[**]) [**] the New Commercial
Licensee; provided, however, that no such license fee payment shall be paid or
payable by Millennium to Schering pursuant to this Section 9.1(a) if:
(i) the submission by Schering of all documentation
required to be submitted by Schering to the Regulatory Authorities [**] to
the New Commercial Licensee does not occur before [**]; (the "Submission Date");
provided, however, that in the event that such submission occurs after [**] as a
result of [**], as applicable, pursuant to Section 5.1(b), the Submission Date
shall be [**] an amount of time equivalent to the period [**], but in no event
shall the Submission Date be [**] the Closing Date;
(ii) the Regulatory Approvals for INTEGRILIN Products
existing as of the Effective Date in the Transferring Territory are [**]
applicable product specifications, cGMP requirements or Regulatory Approvals; or
(iii) [**] on or before [**].
(b) If at any time prior to the [**] distribution and
commercial sale in the Transferring Territory [**] product specifications, cGMP
requirements or Regulatory Approvals, then the license fee set forth in
Section 9.1(a) shall be [**] INTEGRILIN Products. Such [**] Existing Inventory
that is [**], as follows:
$[**] Y/X
where X = [**]
Y = [**] Existing Inventory [**].
Thus, for example, if [**] of the Existing Inventory [**], then the license
fee would be equal to [**] dollars ($[**]), i.e.,
$[**]
In the event of any disagreement between Schering and Millennium over the [**]
Existing Inventory [**], Millennium shall have the right to audit Schering's
relevant books and records related to the Existing Inventory. The Parties
acknowledge that under no circumstances will the license fee payable under
Section 9.1 ever be greater than $[**].
(c) Schering shall be entitled to send Millennium an invoice
for the license fee payment set forth in Section 9.1(a) upon the receipt of
written notice by Millennium that such transfer of the Central Marketing
Authorization to the New Commercial Licensee is in full force and effect. Such
invoice shall be payable by Millennium within [**] of receipt from Schering.
Section 9.2 Royalties Payable to Schering.
(a) Millennium shall make royalty payments to Schering on
annual SP-Royalty Sales of INTEGRILIN Products in the Transferring Territory by
Millennium, its New Commercial Licensee or their respective Affiliates to
unrelated third parties in excess of [**] dollars ($[**]) in the aggregate
during each full or partial calendar year after [**] (the "Annual Sales
Threshold"). The term "SP-Royalty Sales" shall mean the [**] INTEGRILIN Product
[**] the Collaboration Agreement. In addition, SP-Royalty Sales shall [**]
INTEGRILIN Products and, to the extent [**]. SP-Royalty Sales of INTEGRILIN
Products in the Transferring Territory that are [**] INTEGRILIN will be
determined in the same manner [**] the Collaboration Agreement for
Royalty-Bearing Products which are combination products. Royalties under this
Section 9.2 shall be determined on a country-by-country basis for countries in
the Transferring Territory, and shall be equal to [**]: (i) [**] percent ([**]%)
of any royalty payments received by Millennium from the New Commercial Licensee
under the New Commercial Agreement as a result of sales of INTEGRILIN Products
in the country or countries in the Transferring Territory that represent sales
during the immediately preceding full or partial calendar year in excess of the
Annual Sales Threshold; or (ii) [**] percent ([**]%) of SP-Royalty Sales (as
defined below) of INTEGRILIN Products in such country or countries in the
Transferring Territory that represent sales during the immediately preceding
full or partial calendar year in excess of the Annual Sales Threshold. In the
event that [**], and the Regulatory Approvals in the Transferring Territory are
transferred to Millennium pursuant to Section 2.6(c), then the royalty payable
under this Section 9.2(a) shall be determined solely on the basis of (ii) above
for annual SP-Royalty Sales in excess of [**] dollars ($[**]), until such time
thereafter as Millennium and a New Commercial Licensee execute a New
Commercial Agreement.
(b) Royalty payments under Section 9.2(a) shall be made to
Schering or its designee within [**] following the end of each year for which
royalties are due. Each royalty payment shall be accompanied by a statement
summarizing the SP-Royalty Sales during the relevant year. To the extent such
royalties accrue in countries where the currency is blocked, royalty payments
due hereunder shall be paid promptly following the removal of relevant currency
restrictions.
(c) Millennium's obligation to pay royalties under this Section
9.2 shall expire on a country-by-country basis on the last to expire Patent in
such country which is owned or controlled by Millennium or Schering and [**] the
INTEGRILIN Products, but no later than [**]; PROVIDED, HOWEVER, that [**] that
are discovered after the Effective Date shall be excluded in determining the
duration of Millennium's royalty obligations under this Section 9.2.
(d) For the purpose of computing the Royalty-Bearing Sales for
INTEGRILIN sold in a currency other than United States dollars, such currency
shall be converted into United States dollars at a rate calculated using the New
Commercial Licensee's ([**]) customary and usual procedures for currency
conversion for a given time period; PROVIDED that such procedures utilize the
currency exchange spot rates certified by the Federal Reserve Bank or the
currency exchange rates published in the Wall Street Journal (New York edition)
or another internationally recognized financial publication agreed to by the
Parties. Millennium shall require the New Commercial Licensee to provide
Millennium prompt written notice of any changes to such procedures, which
Millennium shall then promptly provide to Schering.
(e) The terms of Sections 9.10, 9.15 and 9.18 of the
Collaboration Agreement shall apply to the royalty payment obligations set forth
in this Section 9.2.
(f) No royalties shall be payable during periods in which
Schering is in material breach of this Agreement.
(g) The terms and conditions of this Section 9.2 shall
supersede and replace the terms of Section 9.8 of the Collaboration Agreement
with respect to all countries in the Transferring Territory.
ARTICLE X
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS
Section 10.1 Exclusivity Covenant.
(a) During the Negotiation Period and the Transition Period,
neither Schering nor its Affiliates shall Commercialize any Competing Product in
the Field, directly or indirectly, in the Transferring Territory. For purposes
of clarity, nothing in this Section 10.1 is intended to restrict Schering or its
Affiliates, alone or in collaboration with a Third Party, from undertaking
research or Development activities with respect to Competing Products.
"Competing Product" means [**]. "Field" means [**].
(b) Without limiting the application of Section 10.1(a), no
royalties shall be payable under Article IX in periods in which [**], directly
or indirectly, in the Transferring Territory.
Section 10.2 Consents.
Schering represents and warrants to Millennium that all necessary consents,
approvals (including pricing and reimbursement approvals) and authorizations of
all regulatory authorities that have been obtained by Schering or its Affiliates
as of the Effective Date in order to Develop, Manufacture and Commercialize
INTEGRILIN Products in the Transferring Territory pursuant to the Collaboration
Agreement are in full force and effect. Schering represents and warrants to
Millennium that as of the Effective Date it has no knowledge of any plan by any
regulatory authority to withdraw or challenge any issued Regulatory Approval for
the INTEGRILIN Products in the Transferring Territory.
Section 10.3 No Violation of Law and No Breach of Contract.
(a) Schering represents and warrants to Millennium that as of
the Effective Date the Development, Manufacture and Commercialization of
INTEGRILIN Products in the Transferring Territory by Schering and its Affiliates
is being performed in compliance with all applicable laws, rules and
regulations.
(b) Schering represents and warrants to Millennium that as of
the Effective Date it is not in breach or default of any of its contractual
obligations under the Collaboration Agreement.
(c) Schering represents and warrants to Millennium that as of
the Effective Date it is not in breach or default of any of its contractual
obligations under any Third Party contract related to the Development,
Manufacture or Commercialization of INTEGRILIN Products in or for the
Transferring Territory.
Section 10.4 Sales Representatives' Compliance.
Schering covenants to Millennium that during the Negotiation Period and the
Transition Period it shall ensure that the marketing and promotion of INTEGRILIN
Products in the Transferring Territory by its sales representatives will be
conducted in accordance with all applicable laws, rules and regulations and in a
manner consistent with the current applicable package insert of prescribing
information approved for INTEGRILIN Products in the Transferring Territory.
Section 10.5 Sales of INTEGRILIN Products.
Schering hereby represents and warrants to Millennium that sales (in units)
of the INTEGRILIN Products sold by Schering in the Transferring Territory during
the [**] period immediately prior to the Effective Date (such period [**]) are
[**] the INTEGRILIN Products [**] period immediately preceding [**]. As used in
this Section 10.5, the term [**] shall mean [**] in one or more countries in the
Transferring Territory of more than [**] during the [**] as compared to the [**]
in the same country or countries (as applicable) during the [**] period [**].
Section 10.6 Intellectual Property and Documentation.
Schering represents and warrants to Millennium that, as of the Effective
Date:
(a) There are [**] in the Transferring Territory owned by
Schering or its Affiliates [**] INTEGRILIN or INTEGRILIN Products.
(b) Schering has not granted any license to any Third Party
under any of the Trademarks, Patent Rights or Know-how concerning (i) the
Development or Commercialization of INTEGRILIN in and for the Transferring
Territory, or (ii) the Manufacture of INTEGRILIN for such Development and
Commercialization, and Schering has the authority and the ability to sublicense
such Trademarks, Patent Rights or Know-how to Millennium and the New Commercial
Licensee as provided in this Agreement.
(c) EXHIBIT B attached hereto is an accurate and complete list
of all Trademark applications and registrations that are directed to the name
"INTEGRILIN" [**] in the Transferring Territory. To Schering's knowledge, such
Trademarks are owned by Millennium (as successor in interest to COR
Therapeutics, Inc.) and are free and clear of any liens, charges and
encumbrances.
(d) To the best of Schering's knowledge, neither the
Development nor Commercialization of INTEGRILIN in the Transferring Territory,
nor the Manufacture of INTEGRILIN for such Development and Commercialization, as
conducted by Schering pursuant to the Collaboration Agreement has infringed or
will infringe, or has resulted or will result in the misappropriation of any
intellectual property rights owned by any Third Party.
(e) No claim of infringement of the intellectual property
rights of any Third Party has been made nor, to Schering's knowledge, threatened
against Schering or any of its Affiliates with respect to the Development,
Manufacture or Commercialization of INTEGRILIN Products in or for the
Transferring Territory, and there are no judgments or settlements against or
owed by Schering or to which Schering is a party relating to the Development,
Manufacture or Commercialization of INTEGRILIN Products in or for the
Transferring Territory.
(f) As of the Effective Date, to the best of Schering's
knowledge after diligent inquiry, there are no patentable inventions made by
Schering's employees that relate to an INTEGRILIN Product, including its
manufacture or use, that Schering would be required to assign to Millennium
pursuant to by Section 12.1(b) of the Collaboration Agreement.
(g) All of the studies, tests and pre-clinical and clinical
trials of INTEGRILIN Products conducted or sponsored by Schering prior to, or
being conducted or sponsored by Schering as of, the date of this Agreement in
and for the Transferring Territory have been and are being conducted in
accordance with applicable laws, rules and regulations.
Section 10.7 Third Party Contracts.
Schering represents and warrants to Millennium that, to the best of its
knowledge, as of the Effective Date, there are [**], and during the Negotiation
Period, [**] and the Transition Period, Schering shall not enter into any such
agreements. During the Negotiation Period, [**] and the Transition Period,
Schering shall use Diligent Efforts not to take or omit to take any actions that
would constitute a breach of a material term of any of its existing Third Party
contracts related to the Development, Manufacture or Commercialization of
INTEGRILIN Products in the Transferring Territory, and shall not enter into any
amendment to any such agreement, which breach or amendment would be reasonably
likely to have a material adverse effect on the Development or Commercialization
of INTEGRILIN in the Transferring Territory. Schering shall provide Millennium
promptly with written notice of the occurrence of any such breach (or Schering's
receipt of notice of an allegation of any such breach).
Section 10.8 Adequacy of Disclosure.
Schering represents and warrants to Millennium that, as of the Effective
Date, it has not withheld or otherwise failed to disclose to Millennium any
material information necessary for the Development, Manufacture or
Commercialization of INTEGRILIN Products in the Transferring Territory. Without
limiting the generality of the preceding sentence, Schering represents and
warrants to Millennium that, as of the Effective Date, there are no:
(a) agreements granting a Third Party any right of first
refusal, right of first negotiation, right of first
offer or other similar right with respect to
INTEGRILIN Products in or for the Transferring
Territory;
(b) any joint venture, partnership, strategic alliance,
and similar agreements relating to INTEGRILIN
Products in or for the Transferring Territory;
(c) agreements under which a royalty would be paid on
sales of INTEGRILIN Products in or for the
Transferring Territory; or
(d) agreements that include a non-competition,
restriction on competition, exclusivity or similar
provision related to INTEGRILIN Products in or for
the Transferring Territory.
In addition, Schering represents and warrants that all such material
information disclosed to Millennium hereunder is accurate, truthful and complete
to the best of its knowledge and that in connection with information contained
on EXHIBIT D hereto (INTEGRILIN Sales Information), Schering's knowledge is
based on its recent diligent inquiry.
Section 10.9 Product Liability Claims.
Schering represents and warrants that as of the Effective Date there are no
product liability claims pending, and none have been brought, in connection with
the Commercialization of INTEGRILIN Products [**] immediately preceding the
Effective Date: [**].
Section 10.10 Debarment.
Each Party represents and warrants to the other that, neither that Party
nor any of its Affiliates has been debarred or is subject to debarment and
neither that Party nor any of its Affiliates has used, is using or will use in
any capacity, in connection with the Development, Manufacture or
Commercialization of INTEGRILIN Products in or for the Transferring Territory,
any person who has been debarred pursuant to Section 306 of the United States
Federal Food, Drug, and Cosmetic Act, or who is the subject of a conviction
described in such section. Each Party agrees to inform the other Party in
writing immediately if it or any person who is performing services hereunder is
debarred or is the subject of a conviction described in Section 306, or if any
action, suit, claim, investigation or legal or administrative proceeding is
pending or, to the best of such Party's knowledge, is threatened, relating to
the debarment or conviction of such Party or any person used in any capacity by
such Party or any of its Affiliates in connection with the Development,
Manufacture or Commercialization of INTEGRILIN Products in or for the
Transferring Territory.
ARTICLE XI
LIABILITY & INDEMNIFICATION
Section 11.1 Pre-Transfer Liability.
The rights and obligations of the Parties with respect to any and all
Liabilities directly or indirectly arising or resulting from activities
performed by the Parties pursuant to this Agreement or the Collaboration
Agreement in any country in the Transferring Territory prior to the Closing
Date, [**] as set forth in Section 2.6(c), [**], and related to the Development,
Manufacture or Commercialization of INTEGRILIN Products in or for the
Transferring Territory (the "Pre-Closing Liabilities") shall, subject to the
waiver of liability with respect to diligence efforts prior to the Effective
Date as set forth in Section 11.10 of this Agreement, continue to be controlled
by and subject to the terms and conditions of the Collaboration Agreement;
PROVIDED, HOWEVER Pre-Closing Liabilities shall not include any "Carry-Forward
Liabilities" as such term is defined in Section 11.3 below.
Section 11.2 Liability During the Transition Period.
The rights and obligations of the Parties with respect to any and all
Liabilities directly or indirectly arising or resulting from activities
performed by the Parties pursuant to this Agreement in any country in the
Transferring Territory during the Transition Period that are related to the
Development, Manufacture or Commercialization of INTEGRILIN Products in or for
the Transferring Territory (the "Transition Liabilities") shall be allocated as
follows:
(a) Subject to Section 11.6(b) hereof, to the extent that
Schering remains responsible for and continues to perform one or more activities
related to the Development, Manufacture or Commercialization of INTEGRILIN
Products in or for one or more countries in the Transferring Territory during
the Transition Period, Transition Liabilities arising from the performance of
such activity(ies) by Schering or its Affiliates in or for such country(ies)
shall be controlled by and subject to the terms and conditions of the
Collaboration Agreement, as expressly modified by the terms of Sections 3.4
(Schering's Diligence Obligations during the Transition Period) and 7.2
(Clinical Development During the Transition Period) of this Agreement; or
(b) to the extent that Schering has completed the Transfer to
Millennium or its New Commercial Licensee of responsibility for performance of
one or more activities related to the Development, Manufacture or
Commercialization of INTEGRILIN Products in one or more countries in the
Transferring Territory, then effective as of Schering's receipt of the relevant
Country Approval Notice, any Transition Liabilities arising from the performance
of such activity(ies) by Millennium and/or the New Commercial Licensee in such
country(ies) shall be treated as a Post-Transfer Liabilities in accordance with
the terms of Section 11.3 of this Agreement.
Section 11.3 Post-Transfer Liability.
Except as otherwise expressly set forth in this Agreement, Millennium and
the New Commercial Licensee shall be solely responsible for, and Schering shall
have no responsibility or liability under this Agreement or the Collaboration
Agreement or otherwise with respect to, any and all Liabilities directly or
indirectly arising or resulting from any and all activities performed by
Millennium, the New Commercial Licensee or their respective Affiliates or
agents, related to the Development or Commercialization of INTEGRILIN Products
in the Transferring Territory or the Manufacture of INTEGRILIN Products for the
Transferring Territory (the "Post-Transfer Liabilities"). Notwithstanding the
preceding sentence, "Post-Transfer Liabilities" shall not include any and all
Liabilities to the extent directly or indirectly arising or resulting from the
following (the "Carry-Forward Liabilities"):
(a) the contents in any information (including clinical data
and results), documents or records prepared and furnished to Millennium or its
New Commercial Licensee by Schering, including without limitation any errors or
omissions contained therein;
(b) the performance of any clinical trials or other Development
activities conducted in the Transferring Territory by Schering or its agents
after the first to occur of (i) on a country-by-country basis, Schering's
receipt of the relevant Country Approval Notice or (ii) the Final Approval
Notice;
(c) the Manufacture in or for the Transferring Territory and
any sales or distribution of INTEGRILIN Products by Schering or its agents in
the Transferring Territory after the first to occur of (i) on a
country-by-country basis, Schering's receipt of the relevant Country Approval
Notice or (ii) the Final Approval Notice, including Liabilities arising under
any related Third Party contracts for which Schering retains responsibility
pursuant to Section 8.1(c);
(d) the performance of pharmacovigilance activities conducted
by Schering or its agents after the first to occur of (i) on a
country-by-country basis, Schering's receipt of the relevant Country Approval
Notice or (ii) the Final Approval Notice; and
(e) the contents of Marketing Materials prepared by Schering or its
agents.
The rights and obligations of the Parties with respect to any and all
payments for Carry-Forward Liabilities shall be controlled by and subject to the
terms and conditions of the Collaboration Agreement, including without
limitation the right to treat such payments and fees as Development Costs and/or
Allowable Expenses, as may be appropriate.
Section 11.4 No Effect on Liabilities outside the Transferring Territory.
Nothing in this Agreement shall be construed (expressly or by implication)
as modifying, superseding or otherwise amending the rights and obligations of
the Parties with respect to any and all claims, suits, liabilities, debts,
losses, damages, demands, judgments or awards arising from or connected with the
Development, Manufacture or Commercialization of INTEGRILIN Products by or on
behalf of Millennium and/or Schering in countries outside the Transferring
Territory (the "Excluded Liabilities"), which are and shall continue to be
controlled by and subject to the terms and conditions of the Collaboration
Agreement. The Parties acknowledge and agree that the New Commercial Licensee
shall have no rights, responsibilities or liabilities whatsoever with respect to
any Excluded Liability.
Section 11.5 Indemnification by Schering.
Schering shall indemnify, defend and hold harmless Millennium, the New
Commercial Licensee and their respective Affiliates, directors, officers,
employees and agents (collectively, the "Non-Schering Indemnified Parties") from
and against any and all suits, claims, actions, demands, liabilities, losses or
expenses (including, without limitation reasonable attorneys' and experts' fees)
(collectively "Losses") resulting directly or indirectly from: (i) any breach
of, or inaccuracy in any representation or warranty made by Schering in this
Agreement (except for the representation and warranty of Schering set forth in
Section 10.3(b) hereof); (ii) the breach of one or more of Schering's material
obligations under this Agreement; (iii) the negligence or intentional misconduct
of Schering or its Affiliates in connection with the performance of its
obligations under this Agreement; or (iv) the Carry-Forward Liabilities; except
in each case to the extent caused by the negligence or intentional misconduct of
Millennium or any other Non-Schering Indemnified Party; PROVIDED, HOWEVER, that
the terms of this Section 11.5 shall not apply and Schering shall have no
indemnification obligations under this Section 11.5 with respect to any
Pre-Closing Liabilities, Post-Transfer Liabilities or Excluded Liabilities.
Section 11.6 Indemnification by Millennium.
(a) Millennium shall indemnify, defend and hold harmless
Schering, its Affiliates, and their directors, officers, employees and agents
(collectively, the "Schering Indemnified Parties") from and against any and all
Losses resulting directly or indirectly from: (i) the breach of one or more of
Millennium's material obligations under this Agreement; (ii) the negligence or
intentional misconduct of Millennium or its Affiliates in connection with the
performance of its obligations under this Agreement; or (iii) any Post-Transfer
Liabilities, except in each case to the extent caused by the negligence or
intentional misconduct of Schering or any other Schering Indemnified Party; and
PROVIDED; HOWEVER, that the terms of this Section 11.6 shall not apply and
Millennium shall have no indemnification obligations under this Section 11.6
with respect to any Pre-Closing Liabilities, Carry-forward Liabilities or
Excluded Liabilities.
(b) As of the Closing Date, Millennium shall procure that the
New Commercial Licensee shall, indemnify, defend and hold harmless the Schering
Indemnified Parties from and against any and all Losses resulting directly or
indirectly from any Post-Transfer Liabilities or Liabilities arising from New
Commercial Licensee's activities as a co-promoter as set forth in Section 8.1
hereof, except in each case to the extent caused by the negligence or
intentional misconduct of Schering or any other Schering Indemnified Party.
Section 11.7 Procedures.
Each Party agrees to promptly give the other Party written notice of any
claim for which indemnification may be sought under this Agreement. Failure of
an indemnified Party to provide notice of a claim to the indemnifying Party
shall only affect the indemnified Party's right to indemnification if and to the
extent that such failure has a material adverse effect on the indemnifying
Party's ability to defend or the nature or the amount of the relevant Losses.
The indemnifying Party shall have the right to assume the defense of any suit or
claim related to the Losses if it has assumed responsibility for the suit or
claim in writing; PROVIDED, HOWEVER, that if in the reasonable judgment of the
indemnified Party, such suit or claim involves an issue or matter which could
have a materially adverse effect on the business operations or assets of the
indemnified Party, the indemnified Party may waive its rights to indemnity under
this Agreement and control the defense or settlement thereof, but in no event
shall any such waiver be construed as a waiver of any indemnification rights
which such Party may have at law or in equity. If the indemnifying Party defends
the suit or claim, the indemnified Party may participate in (but not control)
the defense thereof at its sole cost and expense.
Section 11.8 Settlements.
Neither Party may settle a claim or action related to any Losses without
the prior written consent of the other Party if such settlement would impose any
monetary obligation on the other Party or require the other Party to submit to
an injunction or otherwise limit the other Party's rights under this Agreement;
PROVIDED that such consent shall not be unreasonably withheld or delayed. Any
payment made by a Party to settle any such claim or action shall be at its own
cost and expense.
Section 11.9 No Consequential Damages.
With respect to any claim by one Party against the other arising out of the
performance or failure of performance of the other Party under this Agreement,
the Parties expressly agree that the liability of such Party to the other Party
for such breach shall be limited under this Agreement or otherwise at law or
equity to direct damages only and in no event shall a Party be liable for any
indirect, special, punitive, exemplary or consequential damages suffered or
incurred by the other Party.
Section 11.10 Non-Assertion and Waiver of Certain Claims.
(a) The waiver set forth in this Section 11.10(a) shall become
effective and irrevocable, upon completion of the Transfer of all Regulatory
Approvals in the Transferring Territory, such Transfer of all Regulatory
Approvals in the Transferring Territory to be deemed complete for purposes of
this Section 11.10(a) upon the first to occur of (i) the expiration of the
Transition Period subject to [**] the INTEGRILIN Products being complete, or
(ii) the date of the Final Approval Notice from Millennium pursuant to Section
11.10(d).
(i) Each Party (the "Releasing Party") [**] and its
Affiliates [**], that the Releasing Party [**] the Released Party or its
Affiliates as a result of or in connection with [**] the Collaboration Agreement
[**] between the Parties, [**] occurring prior to the Effective Date with regard
to [**] INTEGRILIN Products [**]. The foregoing [**] shall include, without
limitation, [**] INTEGRILIN Products; [**] INTEGRILIN Products; [**] INTEGRILIN
Products [**] INTEGRILIN Products. For clarity, [**] the Collaboration Agreement
for Third Party claims.
(ii) [**] Section 11.10(a)(i) shall be [**].
(b) Upon the Effective Date [**]:
(i) Millennium agrees that it will [**] be waived
under Section 11.10(a); and
(ii) the Parties agree to [**], and Schering agrees
that it will [**](except for [**] regard to the time [**]).
(c) Schering shall promptly notify Millennium in writing upon
completion by Schering of (i) the submission of all documentation necessary for
the assignment and transfer to Millennium or the New Commercial Licensee, as
applicable, of all Regulatory Approvals held by Schering or its Affiliates for
the Commercialization of INTEGRILIN in the Transferring Territory, and (ii) the
transfer by Schering to Millennium or the New Commercial Licensee of all
documentation necessary to enable Millennium or the New Commercial Licensee to
Manufacture INTEGRILIN Products for distribution and sale in the Transferring
Territory). Within thirty (30) days after receipt of such notice, Millennium
shall provide Schering either with written notice either confirming its
understanding that Schering has completed all such submissions and transfers
("Acceptance Notice"), or written notice specifically identifying any such
submissions or transfers that remain incomplete ("Shortfall Notice"); provided
that failure by Millennium to provide a Shortfall Notice within such thirty (30)
day period shall be deemed to be an Acceptance Notice by Millennium. Schering
shall promptly handle any remaining submissions or transfers specified in a
Shortfall Notice in accordance with the provisions of Article V. However, in the
event that Schering and Millennium disagree as to whether or not one or more
submissions or transfers identified in a Shortfall Notice has been reasonably
completed, then the Parties' executive officers shall resolve within thirty (30)
days such dispute through good faith negotiations.
(d) Millennium shall promptly notify Schering in writing upon
receipt by Millennium or the New Commercial Licensee of all necessary Regulatory
Approvals in the Transferring Territory to enable Millennium or the New
Commercial Licensee to Commercialize and Manufacture INTEGRILIN Products in the
Transferring Territory ("Final Approval Notice").
ARTICLE XII
MISCELLANEOUS
Section 12.1 Notices. The mailing addresses for Millennium under Section
18.4 of the Collaboration Agreement are changed to:
For Millennium: Millennium Pharmaceuticals, Inc.
00 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000
X.X.X.
Attention: Chief Executive Officer
Facsimile No.: (000) 000-0000
With a copy to: Millennium Pharmaceuticals, Inc.
00 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000
X.X.X.
Attention: General Counsel
Facsimile No.: (000) 000-0000
The mailing address for Schering-Plough Ltd. under Section 18.4 of the
Collaboration Agreement is changed to:
Schering-Plough Ltd.
Xxxxxxxxxx 00, X.X. Xxx
XX-0000 Xxxxxxx 0
Xxxxxxxxxxx
Attention: President
Facsimile No.: 41 41 418 16 26
Section 12.2 Integration; Survival; Term; Relationship to Collaboration
Agreement and Controlling Provisions.
This Agreement, together with the Collaboration Agreement (as amended and
supplemented by this Agreement), constitutes the entire agreement between the
Parties concerning the subject matter of this Agreement and supersedes all
previous agreements, whether written or oral. Sections 2.3, 3.3, 4.1, 4.2, 4.3,
4.4, 4.5, 5.2(b), 5.3 (first 2 paragraphs), 5.4, Article VI, 7.3, 8.2, 9.2,
10.1(b), Article XI, 12.1, 12.2, 12.3, 12.4 and 12.5 shall survive the
expiration of this Agreement. This Agreement may be amended only in the manner
provided in Section 18.1 of the Collaboration Agreement; provided that,
effective as of the Closing Date, any amendment pertaining to the provisions set
forth in Sections 12.4(i), (ii) and (iii) and Article X hereof may be amended
only with the prior written consent of New Commercial Licensee, such consent not
to be unreasonably withheld. The term of this Agreement shall be the same as the
term of the Collaboration Agreement.
The Parties acknowledge that the Collaboration Agreement survives, except
to the extent amended or supplemented by this Agreement. For purposes of
clarity, the Parties agree that to the extent that the terms and conditions of
this Agreement are inconsistent with the terms and conditions of the
Collaboration Agreement, the terms of this Agreement shall control. In
particular, (i) the change in addresses for notice set forth in Section 12.1,
(ii) the change in governing law set forth in Section 12.3(a), and (iii) the
amendments to the Collaboration Agreement set forth in Section 12.3(b) of this
Agreement, shall each apply on a worldwide basis to all matters arising under or
in connection with this Agreement and/or the Collaboration Agreement both in the
Transferring Territory and outside the Transferring Territory.
Section 12.3 Governing Law; Dispute Resolution.
(a) This Agreement and the Collaboration Agreement shall be
construed in accordance with, and governed in all respects by, the laws of the
State of New York (without giving effect to principles of conflicts of laws that
would require the application of any other law).
(b) As of the Effective Date, any and all disputes,
controversies or claims between the Parties arising out of, relating to or in
connection with this Agreement or the Collaboration Agreement, including without
limitation those disputes relating to the rights and obligations of the Parties
and/or performance by the Parties under this Agreement and/or the Collaboration
Agreement shall be governed by Section 17.1 of the Collaboration Agreement.
However, notwithstanding anything in Article 17 of the Collaboration Agreement
to the contrary, the term "ADR" as defined in Section 17.2 of the Collaboration
Agreement is hereby amended to mean the arbitration procedures set forth in this
Section 12.3(b) and Sections 17.2(a)-(c), 17.3-17.15 of the Collaboration
Agreement are hereby deleted in their entirety. Any disputed matter to be
settled by ADR shall be finally settled by binding arbitration in accordance
with the commercial arbitration rules of the American Arbitration Association
("AAA") then in force by a panel of three arbitrators appointed in accordance
with said rules (the "Arbitrators"); provided that the Arbitrators shall have
appropriate experience in the biopharmaceutical industry. The place of
arbitration shall be New York, New York, and any written evidence originally in
a language other than English shall be submitted in English translation
accompanied by the original or a true copy thereof. The award rendered shall be
final and binding upon all parties participating in such arbitration. The
judgment rendered by the Arbitrators may, at the Arbitrators' discretion,
include costs of arbitration, reasonable attorneys' fees and reasonable costs
for any experts and other witnesses. Nothing in this Agreement shall be deemed
as preventing either Party from seeking injunctive relief from any court having
jurisdiction over the Parties and the subject matter of the dispute as necessary
to protect any Party's name, proprietary information, trade secrets, know-how or
any other proprietary rights. Judgment upon the award may be entered in any
court having jurisdiction, or application may be made to such court for judicial
acceptance of the award and/or an order of enforcement as the case may be. The
Parties agree to use their good faith efforts to resolve the dispute within six
(6) months of receipt of the original notice of dispute and any arbitration
pursuant to this Section 12.3(b) must be completed within one (1) year of such
notice. Notwithstanding the foregoing, any disputes regarding the scope,
validity, enforceability or inventorship of any patents or patent applications
shall be submitted for final resolution by a court of competent jurisdiction.
Section 12.4 Intended Third Party Beneficiary.
The Parties intend that, effective on the Closing Date, the New Commercial
Licensee shall be deemed an intended third party beneficiary of this Agreement
(including, without limitation, Article X) with respect to:
(i) Millennium's rights to Develop, Commercialize and
Manufacture INTEGRILIN Products in the Transferring Territory under this
Agreement;
(ii) Schering's obligations under Sections 3.2(c),
3.2(d), 3.3, 3.4, 4.3, 4.4, 5.1, 5.2, 5.3, 7.2 and 8.1; and
(iii) Schering's indemnification obligations under
Sections 11.2, 11.4 (last sentence only), and 11.5.
The New Commercial Licensee's rights as a third party beneficiary shall be
subject to compliance by Millennium and the New Commercial Licensee with the
terms and conditions, as applicable, of Sections 3.3, 5.1(b), 5.5, 7.3, 11.2(b),
11.3, 11.6(b), 11.7, 11.8, 11.9 and 11.10 of this Agreement. In addition,
Millennium shall require the New Commercial Licensee to agree to be bound by
Section 12.3 of this Agreement with regard to its enforcement of the terms of
this Agreement as an intended third party beneficiary, and to agree to join or
be joined by Schering or Millennium in any proceeding described in Section 12.3
of this Agreement pertaining to each of Millennium, Schering and New Commercial
Licensee; PROVIDED, HOWEVER, that the New Commercial Licensee may enforce its
rights hereunder as a third party beneficiary by going directly to dispute
resolution under Section 12.3(b) hereof and is not required to first submit the
dispute to the JSC as set forth in Section 17.1 of the Collaboration Agreement.
Schering and Millennium each agree that it will not oppose such joinder by the
other Party of the New Commercial Licensee to any such proceeding.
Section 12.5 Assignment.
Schering agrees that all rights enjoyed by the New Commercial Licensee
under this Agreement may be assigned to Millennium or its designee upon any
termination of the New Commercial Agreement.
Section 12.6 Execution in Counterparts; Facsimile Signatures.
This Agreement may be executed in counterparts, each of which counterparts,
when so executed and delivered, shall be deemed to be an original, and all of
which counterparts, taken together, shall constitute one and the same instrument
even if both Parties have not executed the same counterpart. Signatures provided
by facsimile transmission shall be deemed to be original signatures.
[Remainder of page intentionally left blank.]
IN WITNESS WHEREOF, Millennium, Schering Corporation andSchering-Plough
Ltd. have caused this Agreement to be duly executed by their authorized
representatives under seal, in duplicate on the dates written below.
MILLENNIUM PHARMACEUTICALS, INC.
By: /S/ XXXX XXXXX
Name (Print): XXXX XXXXX
Title: Chief Executive Officer
Date: June 21, 2004
SCHERING CORPORATION
By: /S/ XXXXXXXX XXXXXXX-XXXXX
Name(Print): XXXXXXXX XXXXXXX-XXXXX
Title: Vice President
Date: 6/21/04
SCHERING-PLOUGH, LTD.
By: /S/ XXXXXX X. XXXXX
-----------------------
Name (Print): XXXXXX X. XXXXX
Title: Manager (Direktor)
Date: 6/21/04
EXHIBIT A
Language to be Incorporated into Press Release (Section 6.1)
DRAFT DRAFT DRAFT DRAFT DRAFT DRAFT
MILLENNIUM AND XXX ANNOUNCE INTEGRILIN(R)(EPTIFIBATIDE) INJECTION
LICENSING AGREEMENT FOR EUROPE
CAMBRIDGE, MASS., JUNE XX, 2004 -- Millennium Pharmaceuticals, Inc. (Nasdaq:
MLNM) today announced that it has entered into an agreement in which XXX will
exclusively market INTEGRILIN(R)(eptifibatide) Injection in Europe.
XXX will actively commercialize INTEGRILIN in Europe upon the approved transfer
of marketing authorizations, which is anticipated to be complete by December
2004. The execution of this agreement between Millennium and XXX for INTEGRILIN
follows its acquisition of the rights to market the product in Europe from its
partner Schering-Plough Corporation (NYSE: SGP). Schering-Plough will continue
to promote INTEGRILIN in Europe until the transfer is complete. Schering-Plough
will continue to co-promote INTEGRILIN with Millennium in the U.S. and sell the
product in all other territories other than Europe, and will continue to pay
Millennium royalties on INTEGRILIN sales outside of the U.S. and Europe. No
financial details of the agreement for the return of the European rights from
Schering-Plough to commercialize INTEGRILIN were disclosed.
ABOUT INTEGRILIN
INTEGRILIN is indicated for the treatment of patients with acute coronary
syndrome (unstable angina/non-ST-segment myocardial infarction), including
patients who are to be managed medically and those undergoing percutaneous
coronary intervention (PCI). It is also indicated in the United States for the
treatment of patients at time of PCI, including in patients undergoing
intracoronary stenting.
INTEGRILIN is contraindicated in patients with a history of bleeding diathesis,
or evidence of abnormal bleeding within the previous 30 days; severe
hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood
pressure greater than 110 mm Hg) not adequately controlled on antihypertensive
therapy; major surgery within the preceding six weeks; history of stroke within
30 days, or any history of hemorrhagic stroke; current or planned administration
of another parenteral GP IIb-IIIa inhibitor; dependency on renal dialysis; or
known hypersensitivity to any component of the product.
Bleeding is the most common complication encountered during INTEGRILIN therapy.
The majority of excess major bleeding events were localized at the femoral
artery access site. Oropharyngeal, genitourinary, gastrointestinal and
retroperitoneal bleeding were also seen more commonly with INTEGRILIN compared
to placebo.
ABOUT MILLENNIUM
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in
Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, a novel cancer
product, co-promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading
cardiovascular product, and has a robust clinical development pipeline of
product candidates. The Company's research, development and commercialization
activities are focused in three therapeutic areas: oncology, cardiovascular, and
inflammation. By applying its knowledge of the human genome, its understanding
of disease mechanisms, and its industrialized drug discovery platform,
Millennium is seeking to develop breakthrough products.
ABOUT SCHERING-PLOUGH
Schering-Plough is a global science-based health care company with leading
prescription, consumer and animal health products. Through internal research and
collaborations with partners, Schering-Plough discovers, develops, manufactures
and markets advanced drug therapies to meet important medical needs.
Schering-Plough's vision is to earn the trust of the physicians, patients and
customers served by its more than 30,000 people around the world.
THIS PRESS RELEASE CONTAINS "FORWARD-LOOKING STATEMENTS," AND OTHER STATEMENTS
ABOUT OUR GROWTH AND FUTURE OPERATING RESULTS, DISCOVERY AND DEVELOPMENT OF
PRODUCTS, POTENTIAL ACQUISITIONS, STRATEGIC ALLIANCES AND INTELLECTUAL PROPERTY.
VARIOUS IMPORTANT RISKS MAY CAUSE THE COMPANY'S ACTUAL RESULTS TO DIFFER
MATERIALLY FROM THE RESULTS INDICATED BY THESE FORWARD-LOOKING STATEMENTS,
INCLUDING: ADVERSE RESULTS IN OUR DRUG DISCOVERY AND CLINICAL DEVELOPMENT
PROGRAMS; FAILURE TO OBTAIN PATENT PROTECTION FOR OUR DISCOVERIES; COMMERCIAL
LIMITATIONS IMPOSED BY PATENTS OWNED OR CONTROLLED BY THIRD PARTIES; OUR
DEPENDENCE UPON STRATEGIC ALLIANCE PARTNERS TO DEVELOP AND COMMERCIALIZE
PRODUCTS AND SERVICES BASED ON OUR WORK; DIFFICULTIES OR DELAYS IN OBTAINING
REGULATORY APPROVALS TO MARKET PRODUCTS AND SERVICES RESULTING FROM OUR
DEVELOPMENT EFFORTS; THE COMMERCIAL SUCCESS OF INTEGRILIN(R) (EPTIFIBATIDE)
INJECTION AND VELCADE(R) (BORTEZOMIB) FOR INJECTION; AND THE REQUIREMENT FOR
SUBSTANTIAL FUNDING TO CONDUCT RESEARCH AND DEVELOPMENT AND TO EXPAND
COMMERCIALIZATION ACTIVITIES. FOR A FURTHER LIST AND DESCRIPTION OF THE RISKS
AND UNCERTAINTIES WE FACE, SEE THE REPORTS WE HAVE FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION. WE DISCLAIM ANY INTENTION OR OBLIGATION TO UPDATE OR REVISE
ANY FORWARD-LOOKING STATEMENTS, WHETHER AS A RESULT OF NEW INFORMATION, FUTURE
EVENTS OR OTHERWISE.
Editor's Note: This release is available under the Media section on the
Company's website at XXX.XXXXXXXXXX.XXX.
###
EXHIBIT B
DISCLOSURE SCHEDULE 10.6(c)
COUNTRY TRADEMARK O. REG DT EXPIRES AP OR REG#
------- --------- --------- ------- ----------
[**] INTEGRILIN WITH CYRILLIC 21OC1998 [**] 3696
[**] INTEGRILIN 11JL1996 [**] 165097
[**] INTEGRILIN WITH CYRILLIC 21SE1999 [**] 990957
[**] INTEGRILIN WITH CYRILLIC 12MY1998 [**] 8704
[**] INTEGRILIN 22AU1995 [**] 583053
[**] INTEGRILIN WITH CYRILLIC 24JA1997 [**] 29711
[**] INTEGRILIN 09OC1997 [**] Z960308
[**] INTEGRILIN 29JL1997 [**] 202278
[**] . INTEGRILIN 29SE1995 [**] 6470/95
[**] INTEGRILIN WITH CYRILLIC 09MY1997 [**] 23575
[**] INTEGRILIN 05MR1996 [**] 143327
[**] INTEGRILIN 09AU1995 [**] 95584237
[**] INTEGRILIN 09AU1995 [**] 2029753
[**] INTEGRILIN 03SE1997 [**] 6620
[**] INTEGRILIN IN CYRILLIC 03SE1997 [**] 6621
[**] INTEGRILIN 26AP1996 [**] 39533178
[**] INTEGRILIN 19MR2001 [**] 125803
[**] INTEGRILIN 26AU1998 [**] 153433
[**] INTEGRILIN 28OC1997 [**] 1463/1997
[**] INTEGRILIN 28AP1995 [**] 170852
[**] INTEGRILIN 04DE1997 [**] 101797
[**] INTEGRILIN 23JL1997 [**] 719702
[**] INTEGRILIN WITH CYRILLIC 28FE2001 [**] 11272
[**] INTEGRILIN WITH CYRILLIC 28AP1997 [**] 3903
[**] INTEGRILIN 20FE1998 [**] M39710
[**] INTEGRILIN IN CYRILLIC 20FE1998 [**] M39709
[**] INTEGRILIN WITH CYRILLIC 15DE1998 [**] 30491
[**] INTEGRILIN 39486
[**] INTEGRILIN WITH CYRILLIC 18AU1997 [**] 4938
[**] INTEGRILIN 31OC1996 [**] 177708
[**] INTEGRILIN 06OC1999 [**] 109031
[**] INTEGRILIN 06MY1996 [**] 309676
[**] INTEGRILIN 21MR1996 [**] 29239
[**] INTEGRILIN 31OC1997 [**] 157963
[**] INTEGRILIN IN CYRILLIC 31OC1997 [**] 157964
[**] INTEGRILIN 25AP1997 [**] 9670467
[**] INTEGRILIN 21JA1999 [**] 184010
[**] INTEGRILIN 03MR2000 [**] 1981878
[**] INTEGRILIN 22MR1996 [**] 310560
[**] INTEGRILIN 24FE1997 [**] 435605
[**] INTEGRILIN WITH CYRILLIC 28OC1998 [**] 3330
[**] INTEGRILIN WITH CYRILLIC 25DE2000 [**] 5754
[**] INTEGRILIN WITH CYRILLIC 08FE1996 [**] 167597
[**] INTEGRILIN WITH CYRILLIC 15AU2000 [**] 15588
[**] INTEGRILIN WITH CYRILLIC 22JA1997 [**] 5876
EXHIBIT C
ONGOING DEVELOPMENT ACTIVITIES
Protocol # Study Title Country
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EXHIBIT D
INTEGRILIN SALES INFORMATION
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TERRITORY PRICE 1 [**] [**] SCHERING
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Footnotes:
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