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DOCUMENT TITLE:  RESTATED DEVELOPMENT AND COMMERCIALIZATION COLLABORATION AGREEMENT .
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Clause Heading
1 - DEFINITIONS
2 - BACKGROUND AND SCOPE OF COLLABORATION
3.1 - Milestone Payments.
3.1.1 - Execution of the Agreement.
3.1.4 - NDA Approval.
3.1.5 - MAA Approval.
3.2 - No Refunds; Other Payments.
4.1.1 - Formation of the PDC.
4.1.2 - PDC Composition and Governance.
4.1.3 - Meetings.
4.1.4 - Responsibilities of the PDC.
4.2 - Product Development Plan.
4.3.1 - Co-Development.
4.3.2 - Otsuka Obligations for Product Development.
4.4 - Supply of Compound for Product Development.
4.3.3 - BMS Obligations for Product Development.
4.5.1 - Transfer of Otsukas Data, Information and Other Documentation to BMS.
4.5.4 - Designated Representatives for Transfer of Information.
4.5.5 - Improvements and Inventions.
4.5.2 - Transfer of BMS Data, Information and Other Documentation to Otsuka.
4.5.3 - Ownership of Data, Information and Other Documentation.
4.6.1 - Regulatory Compliance Obligations of BMS.
4.6.2 - Product Registrations.
4.6.3 - Labeling.
4.6.4 - Adverse Events; Post-Marketing Surveillance; Product Complaints.
4.6.5 - Post-Marketing Surveillance.
4.6.6 - Product Complaints.
4.6.7 - Product Recall.
5.2 - Marketing Plans.
5.1.1 - Formation of the JCC.
5.1.2 - JCC Composition, Governance and Decisionmaking.
5.1.3 - Meetings.
5.1.4 - Responsibilities of the JCC.
5.3.1 - Overall Structure.
(a) - Otsuka or its Affiliates will be the holder of the Product NDA in the United States and the MA in the European Union.
(a) - Grant of Commercialization Rights.
(b) - Commercialization Obligations of BMS.
(a) - Co-Promotion Countries.
(b) - Otsuka Co-Promotion Election and Commitment.
5.3.4 - Reimbursement of Otsukas Sales Force Expenses.
5.3.5 - Sales Team Assignments.
5.3.6 - Training.
5.3.7 - Effective Co-Promotion Practices.
5.3.8 - Exchange of Marketing Information.
5.3.9 - Booking of Sales; Distribution of Product; Collection of Receivables; Option of Otsuka to Assume Services.
5.3.10 - Countries Added to or Removed from the European Union.
5.3.11 - Reimbursement Price Negotiations.
5.3.12 - Distribution Alternative.
5.3.13 - No Delegation of Responsibilities.
(a) - Grant of License.
(b) - Right to Sublicense.
5.4.2 - Grant of Limited License to BMS in the United States.
5.4.3 - Otsukas Reservation of Rights.
5.5 - Product Position in Sales Calls.
(a) - Reserved Territory.
(b) - Animal Products and Human Over-The-Counter Products.
(c) - Manufacture and Purchase of Compound, Compound Forms and Related Compounds; Packaging.
5.6 - Advertising and Promotional Materials.
5.7 - Involvement of Otsuka in Development, Regulatory Affairs and Commercialization Process.
5.8.1 - Supply of Promotional Samples.
5.8.2 - Distribution of Samples.
(a) - Fees for Services in the European Union.
(b) - Fees for Services in the United States.
(a) - Royalties on Net Sales in the Rest of Territory.
(i) - Royalties on Net Sales in Patent Countries.
(ii) - Royalties on Net Sales in Non-Patent Countries.
(b) - Royalties on Net Sales in the United States.
5.9.3 - Payments of Amounts Due.
5.9.4 - Quarterly Royalty Payments.
5.9.5 - Certain Minimum Payments.
(a) - First Year:
(b) - Second Year:
(c) - Third Year:
(d) - Fourth Year:
(e) - Fifth Year:
5.9.6 - Regular Reports Pertaining to the United States and the European Union.
5.9.7 - Quarterly Reports.
(a) - Royalties in the Rest of Territory.
(b) - Purchase Price for the United States and the Rest of Territory.
(c) - Global Floor Price-Based Adjustment.
(d) - Purchase Price for European Union.
(e) - Minimum Payment Obligation.
(f) - Currency Conversion.
5.9.8 - Books and Records.
5.9.9 - Audits.
5.9.10 - Withholding Tax.
5.10.1 - General.
(c) - Product meets the Target Product Profile;
5.10.3 - Comparable Efforts.
5.10.4 - No Undue Delay.
5.11.1 - Commercial Requirements of Compound and Product.
(a) - Purchase Price.
(b) - Tentative Price.
(c) - Quarterly Reconciliation.
(A) - With Respect to Compound sold by Otsuka to BMS or BMSLC for the United States and the Rest of Territory:
(B) - With Respect to EU Countries where BMS Affiliates are Distributors:
5.11.3 - Global Floor Price-Based Adjustment.
5.11.4 - Packaging.
5.11.5 - Compound Supply Agreement for the United States and the Rest of Territory.
5.11.6 - Product Supply Agreement For the United States.
5.11.7 - Third-Party Intellectual Property That May Be Necessary for the Manufacture, Use or Sale of Product.
5.12 - Trademark.
5.12.2 - Certain Notations.
5.12.3 - Reserved Territory.
5.12.4 - Maintenance.
6.1 - Generally.
6.2 - Initial Offer.
6.3 - Termination.
7.1 - Generally.
7.2 - Definitions.
7.3 - European Union Provisions.
7.4 - Representation.
7.5 - Development of Competitive Products is Permissible.
8.1 - Maintenance of Patent Rights.
8.2.1 - Notice of Infringement.
8.2.2 - BMSs Right to Pursue Remedies Against Infringement.
8.2.3 - Otsukas Right to Pursue Remedies Against Infringement.
8.3.1 - United States and European Union.
8.3.2 - Rest of Territory.
9.1 - Generally.
9.2 - Otsuka.
9.3 - Disclaimers.
9.4 - Survival.
10.1 - Generally.
10.2 - Public Announcements.
11.1 - Allocation of Responsibilities.
11.2 - Indemnification by Otsuka.
11.3 - Indemnification by BMS.
11.4 - Cross-Indemnification.
11.5 - Procedures.
12.1 - Length of Term.
12.2 - Termination for Significant Development Reasons.
12.3 - Termination for Regulatory or Marketing Reasons.
(a) - Termination for Breach.
12.5 - Termination for Insolvency.
12.6 - Termination for BMS Merger.
13.2 - Continued Collaboration.
12.7 - General Effects.
13.1 - Transfer of Rights; Contract Manufacture.
13.3 - Special Transition in EU/US.
13.4 - Survival.
14.1 - Generally.
14.2 - Injunctive Relief
15.1 - Compliance With Laws.
15.2 - No-Hire Clause.
15.3 - Force Majeure.
15.4 - Notices.
15.5 - Entire Agreement; Related Agreements.
15.6 - Waivers and Amendments.
15.7 - Severability.
15.8 - No Partnership.
15.9 - Section Headings.
15.10 - Counterparts.
15.11 - Further Assurances.
15.12 - Assignment.
15.13 - Governing Law.