Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
ASSET PURCHASE AGREEMENT
between
BLUEPRINT MEDICINES CORPORATION
and
RIGEL PHARMACEUTICALS, INC.
DATED AS OF FEBRUARY 22, 2024
TABLE OF CONTENTS
Page
ARTICLE I DEFINITIONS AND TERMS1
Section 1.1Definitions1
Section 1.2Other Definitional Provisions16
ARTICLE II PURCHASE AND SALE; LICENSES16
Section 2.1Purchase and Sale of Assets16
Section 2.2Consents17
Section 2.3Excluded Assets18
Section 2.4Assumption of Liabilities20
Section 2.5Retained Liabilities20
Section 2.6License Grants; Right of Reference21
ARTICLE III CONSIDERATION25
Section 3.1Purchase Price25
Section 3.2Additional Consideration25
ARTICLE IV CLOSING30
Section 4.1Closing30
Section 4.2Additional Transfer Documents32
ARTICLE V REPRESENTATIONS AND WARRANTIES OF SELLER32
Section 5.1Organization; Qualification 32
Section 5.2Title to Assets, Sufficiency32
Section 5.3Authority; Binding Effect33
Section 5.4No Conflicts33
Section 5.5Governmental Authorizations33
Section 5.6Real Property33
Section 5.7No Litigation33
Section 5.8Compliance with Laws34
Section 5.9Product Registrations; Regulatory Compliance34
Section 5.10Intellectual Property; Performance of Transition35
Section 5.11Taxes36
Section 5.12Assumed Contracts36
Section 5.13Anti-Corruption36
Section 5.14Brokers37
Section 5.15No Other Representations or Warranties37
ARTICLE VI REPRESENTATIONS AND WARRANTIES OF PURCHASER38
Section 6.1Organization and Qualification38
Section 6.2Corporate Authorization38
Section 6.3Binding Effect 38
Section 6.4No Conflict38
Section 6.5Governmental Authorization38
Section 6.6Third Party Approvals 38
Section 6.7Financial Capability39
Section 6.8Litigation39
Section 6.9No Debarment 39
Section 6.10Anti-Corruption39
Section 6.11Brokers40
Section 6.12Solvency40
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Section 6.13No Other Representation and/or Warranty40
ARTICLE VII COVENANTS40
Section 7.1Information and Documents40
Section 7.2Conduct41
Section 7.3Insurance41
Section 7.4Trade Notifications41
Section 7.5Included Accounts Receivable; Excluded Accounts Receivable41
Section 7.6Payments under Assumed Contracts42
Section 7.7Transition Services43
Section 7.8Confidentiality43
Section 7.9Wrongfully Transferred or Retained Assets and Liabilities43
Section 7.10[***]43
Section 7.11Further Actions44
ARTICLE VIII CONDITIONS TO CLOSING44
Section 8.1Conditions to the Obligations of Purchaser44
Section 8.2Conditions to the Obligations of Seller45
ARTICLE IX [RESERVED]45
ARTICLE X SURVIVAL OF REPRESENTATIONS AND WARRANTIES;
INDEMNIFICATION 45
Section 10.1Survival45
Section 10.2Indemnification Survival45
Section 10.3Indemnification45
Section 10.4Notice; Defense of Claims48
Section 10.5Remedies Exclusive49
ARTICLE XI MISCELLANEOUS50
Section 11.1Notices50
Section 11.2Amendment; Waiver51
Section 11.3Assignment51
Section 11.4Entire Agreement51
Section 11.5Parties in Interest51
Section 11.6Public Disclosure51
Section 11.7Expenses, Taxes, and Fees51
Section 11.8Schedules52
Section 11.9Governing Law; Jurisdiction52
Section 11.10WAIVER OF JURY TRIAL53
Section 11.11Counterparts53
Section 11.12Headings53
Section 11.13Severability53
Section 11.14Specific Performance54
Section 11.15Non-Recourse54
ATTACHMENTS
EXHIBIT AForm of Bill of Sale and Assignment and Assumption Agreement
EXHIBIT BForm of Intellectual Property Assignment Agreement
EXHIBIT CDisclosure Schedule
EXHIBIT DForm of Transition Agreement
EXHIBIT EForm of Material Transfer Agreement
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ASSET PURCHASE AGREEMENT
This Asset Purchase Agreement is made and entered into as of the 22nd day of February, 2024, between Blueprint Medicines Corporation, a Delaware corporation (“Seller”), and Rigel Pharmaceuticals, Inc., a Delaware corporation (“Purchaser”). Seller and Purchaser are individually referred to as a “Party” and collectively as the “Parties”.
W I T N E S S E T H:
WHEREAS, Seller desires to sell, transfer, assign, convey and deliver to Purchaser, and Purchaser desires to purchase, acquire and assume from Seller, all of Seller’s right, title and interest to the product known as GAVRETO® (pralsetinib) in the United States and other Purchased Assets and Assumed Liabilities, in each case, on the terms and subject to the conditions set forth in this Agreement (the “Transaction”); and
WHEREAS, Seller and Purchaser desire to make certain representations, warranties, covenants, and agreements in connection with the Transaction and prescribe various conditions to the Transaction.
NOW, THEREFORE, in consideration of the foregoing and the representations, warranties, covenants and agreements contained herein, the Parties hereby agree as follows:
“2024 CStone Cooperation Agreement” shall have the meaning set forth in Section 7.6(f).
“AAA” shall have the meaning set forth in Section 7.6(e).
“Accounting Standards” means generally accepted accounting principles as applicable in the U.S. as generally and consistently applied throughout Purchaser’s organization.
“Actual Fraud” means a claim for common law fraud with a specific intent to deceive based on a representation contained in this Agreement; provided that, at the time such representation was made, (i) such representation was inaccurate and (ii) the Party making such representation had actual knowledge of the inaccuracy of such representation.
“Additional Transfer Document” shall have the meaning set forth in Section 4.2(a).
“Affiliate” means, with respect to any Person, any other Person that controls, is controlled by or is under common control with such Person (and for this purpose, the term control means the power to direct, or cause the direction of, the management and policies of a Person (directly or indirectly), whether through ownership of voting securities, by contract or otherwise (and the terms controlling and controlled have meanings correlative to the foregoing)).
“Agreement” means this Asset Purchase Agreement, as the same may be amended or supplemented from time to time in accordance with the terms hereof, including the Exhibits and Schedules hereto.
“Ancillary Agreements” means, collectively, the Bill of Sale and Assignment and Assumption Agreement, the Intellectual Property Assignment Agreement, the Transition Agreement, the Material Transfer Agreement, and the 2024 CStone Cooperation Agreement.
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“Anti-Corruption Laws” shall have the meaning set forth in Section 5.13(a).
“Assumed Contracts” shall have the meaning set forth in Section 2.1(a).
“Assumed Liabilities” shall have the meaning set forth in Section 2.4.
“Bankruptcy Code” shall have the meaning set forth in Section 2.6(g).
“Bill of Sale and Assignment and Assumption Agreement” shall have the meaning set forth in Section 4.1(b)(i).
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“Business” means the Exploitation of the Product in the Territory [***] as of the Closing Date.
“Business Day” means any day other than a Saturday, a Sunday or a day on which banks in New York, New York are authorized or obligated by law or executive order to close.
“Calendar Quarter” means each of the three (3) month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year.
“Calendar Year” means each twelve (12) month period commencing on January 1 and ending on December 31, provided that (a) the first calendar year shall begin on the Closing Date and end on December 31 and (b) the last calendar year shall begin on January 1 and end on the effective date of expiration or termination.
“Change of Control” shall mean (i) any merger, reorganization, consolidation or combination in which the subject entity is not the surviving corporation, or (ii) any “person” (within the meaning of Sections 13(d) and 14(d)(2) of the Securities Exchange Act of 1934), excluding the subject entity and its Affiliates, is or becomes the beneficial owner, directly or indirectly, of securities of the subject entity representing 50% or more of either (a) the then-outstanding shares of common stock of the subject entity or its parent corporation, or (b) the combined voting power of the subject entity’s then outstanding voting securities; or (iii) if individuals who as of the effective date constitute the board of directors of the subject entity or its parent corporation (the “Incumbent Board”) cease for any reason to constitute at least a majority of such Incumbent Board; provided, however, that any individual becoming a director subsequent to the effective date whose election, or nomination for election by the subject entity’s shareholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a person other than the Incumbent Board; or (iv) approval by the shareholders of the subject entity of a complete liquidation or the complete dissolution of the subject entity.
“Claims Threshold” shall have the meaning set forth in Section 10.3(c)(i).
“Closing” means the closing of the transactions contemplated by this Agreement pursuant to Article IV of this Agreement.
“Closing Date” shall have the meaning set forth in Section 4.1(a).
“CMC” means the Chemistry, Manufacturing and Controls portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to the Product.
“CMS” means the Centers for Medicare and Medicaid Services or any successor agency.
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“Combination Product” means: [***] Drug delivery vehicles, adjuvants and excipients will not be deemed to be “active ingredients,” except in the case where such delivery vehicle, adjuvant or excipient is recognized by the FDA as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7).
“Compound” means (a) Seller’s proprietary RET inhibitor known as pralsetinib (also known as BLU-667), or (b) any salt, metabolite, prodrug (including ester prodrug) that convert to the compound described in clause (a), free base, hydrate, solvate, polymorph, stereoisomer or enantiomer of pralsetinib.
“Confidentiality Agreement” means the Confidentiality Agreement between Seller and Purchaser, dated as of [***], as amended or supplemented from time to time.
“Contract” means any written contract, agreement, lease, instrument, note, bond, loan, indenture, license or sublicense, or other legally binding written commitment or arrangement.
“Control” or “Controlled” means, with respect to any Intellectual Property, Regulatory Filing, Regulatory Approval, or other property right, the legal authority or right (whether by ownership, license (other than a license granted pursuant to this Agreement) or otherwise) of a Person or its Affiliate, to grant the right to access or use, or to grant a license or a sublicense to or under such Intellectual Property, Regulatory Filing, Regulatory Approval, or other property right (in whole or in part), without breaching the terms of any agreement or other arrangement between such Person (or any of its Affiliates) and a Third Party or creating a payment obligation upon such Person.
“Controlling Party” shall have the meaning set forth in Section 10.4.
“Cover,” “Covering” or “Covered” means: (a) with respect to a patent, that, in the absence of a license granted to a Person under an issued Valid Claim included in such patent, the practice by such Person of the subject matter at issue would infringe such Valid Claim, or (b) with respect to an application for patent, that, in the absence of a license granted to a Person under a pending Valid Claim included in such application, the practice by such Person of the subject matter at issue would infringe such Valid Claim if such patent application were to issue as a patent.
“CStone” means CStone Pharmaceuticals.
“CStone Agreements” means the CStone License Agreement, that certain Pharmacovigilance Agreement by and among Seller, CStone and Roche dated as of [***].
“CStone License Agreement” means that certain License and Collaboration Agreement between Seller and CStone dated as of June 1, 2018.
“CStone Global Development Plan” means the global development plan agreed by Seller and CStone pursuant to the CStone License Agreement, as may be amended from time to time.
“CStone Territory” means the People’s Republic of China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan.
“Delayed Purchase Price” means Five Million Dollars ($5,000,000), less any set-off permitted by Article X.
“Development Milestone Event” shall have the meaning set forth in Section 3.2(a).
“Development Milestone Payment” shall have the meaning set forth in Section 3.2(a).
“Disclosure Schedule” shall have the meaning set forth in Article V.
“Divestiture” (and other correlative terms) means any transaction in which any Licensed Product and the associated intellectual property assets related to the foregoing are divested or transferred by any means, including by way of merger, consolidation, asset acquisition or sale, exercised option, purchase, sale, assignment or other similar transfer.
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“DMF” means any drug master file with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.
“Excluded Accounts Receivable” shall have the meaning set forth in Section 2.3(e).
“Excluded Assets” shall have the meaning set forth in Section 2.3.
“Excluded Contracts” means all contracts that are not Assumed Contracts.
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“Excluded Intellectual Property” shall have the meaning set forth in Section 2.3(g).
“Exploit” or “Exploiting” means to research, develop, manufacture, import, export, sell, offer for sale or commercialize, or have others do the same. When used as a noun, “Exploitation” means any activities involved in Exploiting.
“FDA” means the United States Food and Drug Administration or any successor agency.
“Federal Healthcare Program” has the meaning set forth in 42 U.S.C. § 1320a-7b(f) and any implementing regulations thereto and, without limiting the foregoing shall include any plan or program that provides health care benefits, whether directly, through insurance, or otherwise, that is funded directly, in whole or in part, by the government of the United States of America (other than the Federal Employees Health Benefits Program), including, without limitation, Medicare, Medicaid, the Children’s Health Insurance Program, TRICARE, 340B Federal Drug Discount Program, and Veterans Health Administration programs (described in Title XVIII of the Social Security Act (“SSA”), Title XIX of the SSA, Title XXI of the SSA, Title 10, Chapter 55 of the U.S.C., 42 U.S.C. § 256b and 38 U.S.C. § 8126, respectively), or any state health care program (as defined in Section 1128(h) of the SSA).
“FFDCA” shall have the meaning set forth in Section 5.9(f).
“Field” means all uses in humans and animals.
“First Commercial Sale” means, with respect to each Licensed Product, the first sale of the Product recorded in accordance with the Accounting Standards by or on behalf of a Selling Party for distribution, use or consumption after the Closing Date. [***]
“Fundamental Claim Expiration Date” shall mean [***] after the expiration of the statute of limitations applicable to the subject matter thereof.
“Fundamental Obligations” shall have the meaning set forth in Section 10.1.
“General Indemnity Cap” means an amount equal to [***].
“General Indemnity Expiration Date” shall have the meaning set forth in Section 10.1.
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“Governmental Authority” means any supranational, national, federal, state or local judicial, legislative, executive, enforcement, administrative or regulatory authority.
“Governmental Authorizations” means all licenses, permits, certificates and other authorizations and approvals under the applicable Laws of any Governmental Authority.
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“Governmental Order” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.
“Healthcare Regulatory Law” means Laws relating to healthcare regulatory matters, including, but not limited to: (a) 42 U.S.C. §§ 1320a-7, 7a, and 7b, which are commonly referred to as the “Federal Fraud Statutes”; Title XVIII of the Social Security Act (42 U.S.C. § 1395 et seq.), the “Medicare Laws”; Title XIX of the Social Security Act (42 U.S.C. § 1396 et seq.), the “Medicaid Laws”; Title XXI of the Social Security Act (42 U.S.C. § 1397 et seq.), the “Children’s Health Insurance Program (CHIP) Laws”; 10 U.S.C. § 1071 et seq., the “TRICARE Laws”; 38 U.S.C. Chapter 17, the “Veterans Health Administration Laws”; 42 U.S.C. § 201 et seq., the “Public Health Service Act”; the Patient Protection and Affordable Care Act (Pub. L. No. 111−148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. No. 111−152); 42 U.S.C. § 1395nn, which is commonly referred to as the “Stark Statute”; 31 U.S.C. §§ 3729-3733, which is commonly referred to as the “Federal False Claims Act”; 42 U.S.C. §§ 286, 287 and 1001, which are commonly referred to as the “Federal Criminal False Claims Statutes,”; 18 U.S.C. § 1035, which is commonly referred to as the “False Statements Relating to Health Care Matters Law”; 31 U.S.C. § 3801 et seq., which is commonly referred to as “Federal Program Fraud Civil Remedies Act”; 42 U.S.C. §§ 1320d through 1320d-8 and 42 C.F.R. §§ 160, 162 and 164, which are commonly referred to as the “Health Insurance Portability and Accountability Act of 1996”; the FFDCA; and any implementing regulations and comparable international, state, or local Laws for any of the foregoing; (b) any Laws governing any Federal Healthcare Program or otherwise governing or regulating the provision of, or payment for, healthcare items and services; (c) any federal, state or local applicable Law that regulates the clinical development, manufacturing, approval, promotion or distribution of products; and (d) any state Law regulating the interactions with health care professionals and reporting thereof.
“Included Accounts Receivable” shall have the meaning set forth in Section 2.1(h).
“IND” means an application submitted to the FDA for authorization to commence clinical studies, including (a) an Investigational New Drug Application as defined in 21 C.F.R. Part 312 or any successor application or procedure submitted to the FDA and (b) all supplements, amendments, variations, extensions and renewals thereof that may be submitted with respect to the foregoing.
“Indemnified Parties” shall have the meaning set forth in Section 10.3(b).
“Indemnifying Party” shall have the meaning set forth in Section 10.4.
“Independent Arbiter” shall have the meaning set forth in Section 7.6(e).
“Indication” means [***] that the Product [***] in the indication section of the label approved by the FDA relevant to usage of the Product [***].
“Insolvent Party” shall have the meaning set forth in Section 2.6(g).
“Intellectual Property” means all patents, trademarks, service marks, logos, trade names, internet domain names, database rights, rights in designs, rights in inventions, trade secrets; rights in information, know-how, trade dress, product livery, source identifiers, all copyrightable works of authorship (whether published or unpublished) and all technology, specifications, information, records, techniques, processes, procedures, documentation, data, databases and other proprietary information that is identified or identifiable in a tangible form, in each case whether registered or unregistered, and all registrations and applications therefor, and all rights or forms of protection having equivalent or similar effect anywhere in the world.
“Intellectual Property Assignment Agreement” shall have the meaning set forth in Section 4.1(b)(iv).
“Knowledge of Seller” means [***].
“Laws” means any federal, state, provincial, regional, territorial, foreign or local law, common law, statute, ordinance, rule, regulation, code, Governmental Order, or requirement issued, enacted, promulgated, implemented or
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otherwise put into effect by or under the authority of any Governmental Authority, consent order, supervisory requirements, directives, circulars, opinions, interpretive letters, guidelines and policies, in each case with the force of law, including Healthcare Regulatory Laws.
“Legal Proceedings” means any litigation complaint (including a qui tam complaint), audit, judicial, administrative or arbitral action, suit, investigation, inquiry, claims (including counterclaims), litigation, civil investigative demand, criminal information, subpoena, search warrant, or proceeding (public or private) by or before a Governmental Authority.
“Liability” and “Liabilities” means any and all Losses, debts, damages, adverse claims, liabilities, commitments and obligations of any nature or kind, whether accrued or unaccrued, fixed, known or unknown, express or implied, absolute or contingent, accrued or unaccrued, disputed, liquidated, executory, matured or unmatured or determined or determinable.
“License” means a grant of rights from Purchaser to an Affiliate or Third Party under any of the Purchased Assets or the rights licensed to Purchaser by Seller under Section 2.6 of the Agreement with respect to the Exploitation of the Product in the Territory, including, for the avoidance of doubt, Third Party distributors.
“Licensed Product” means the pharmaceutical preparation containing Compound as an active ingredient, and any form, formulation, presentation and line extension thereof, including the pralsetinib product known as GAVRETO® (pralsetinib), and including any Combination Product.
“Licensee” means any Affiliate or permitted Third Party granted a License.
“Liens” means any lien, security interest, pledge, mortgage, charge, restriction on transfer conditional sale or other title retention agreement, or other or encumbrance.
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“Loss Tax Benefit” means the cash Tax savings or benefits actually received by such Purchaser Indemnified Party in the taxable period in which the applicable indemnifiable Losses are incurred or the [***] following such taxable period that are attributable to any deduction, loss, credit, refund or other reduction in Tax resulting from or arising out of a Loss, in each case computed at the highest marginal tax rates applicable to the Purchaser Indemnified Party.
“Losses” of a Person means any and all losses, damages, awards, judgments, costs and expenses (including reasonable attorneys’ fees and expenses) actually suffered or incurred by such Person. Notwithstanding anything herein to the contrary, no Indemnified Party shall have the right to be indemnified for any Losses to the extent they are in the nature of consequential damages, incidental or indirect damages, diminution in value damages, lost profits, punitive, special or exemplary damages, and in particular, without limitation, no “multiple of profits” or “multiple of cash flow” or similar valuation methodology shall be used in calculating the amount of any Losses, except to the extent such damages are awarded to a Third Party in connection with a Third Party indemnification claim.
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“Manufacture” or “Manufacturing” means to engage in activities related to and perform the production, manufacture, synthesis, processing, filling, finishing, packaging, labeling, shipping and holding of product or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control, including all development activities enabling Regulatory Approval of Manufacturing. When used as a noun, “Manufacturing” means any of the foregoing activities. “Manufacturing” refers to both nonclinical and clinical Manufacturing for research and development, and Manufacturing for commercialization or future business and/or regulatory requirements.
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“Material Adverse Effect” means a change, effect, event or occurrence that has or would be reasonably expected to have a material adverse effect on the Purchased Assets, taken as a whole, or on the ability of Seller to perform its obligations under, or consummate, the transactions contemplated by this Agreement; provided, however, that none of the following changes, events, effects, occurrences, developments, state of circumstances, facts, or conditions shall be deemed, either alone or in combination, to constitute a Material Adverse Effect, or be taken into account in determining whether there has or will be a Material Adverse Effect: (a) changes or effects in business, economic, tax, regulatory, legal or political conditions or financial markets generally within or outside the United States, provided that such matters will only be excluded so long as such matters do not have a disproportionate adverse effect on the Purchased Assets relative to other comparable assets in the pharmaceutical industry; (b) changes in United States generally accepted accounting principles; (c) changes or effects generally affecting the pharmaceutical and/or biotechnology industry; (d) changes or effects that arise out of or are attributable to the commencement, occurrence, continuation or intensification or reduction or cessation of any war (whether or not declared), sabotage, armed hostilities or acts of terrorism; (e) the occurrence of any act of God or other calamity or force majeure events (whether or not declared as such), including any pandemic (including the COVID-19 pandemic, and any future resurgence, or evolutions or mutations, of COVID-19 or related disease outbreaks, epidemics or pandemics), natural disaster, fire, flood, hurricane, tornado, or other weather event; (f) changes or effects that relate to any failure by Seller to meet internal projections or forecasts for any period (including with respect to the Purchased Assets or the Product); (g) any matter disclosed in, or reasonably determinable from the Disclosure Schedule to this Agreement; (h) any action taken by Seller or its Affiliates as contemplated by this Agreement (including without limitation the Ancillary Agreements) or with Purchaser’s consent; (i) changes or effects that arise out of or are attributable to the negotiation, execution, public announcement or performance of this Agreement; or (j) any existing event or occurrence or circumstance of which Purchaser has actual knowledge as of the date hereof.
“Material Transfer Agreement” shall have the meaning set forth in Section 4.1(b)(vi).
“Milestone Event” shall have the meaning set forth in Section 3.2(a)(ii).
“Milestone Payments” shall have the meaning set forth in Section 3.2(a)(ii).
“NDA” means a new drug application submitted to the FDA pursuant to Section 505(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(b).
“Net Sales” means, with respect to each Payment Product, [***].
“Non-Assignable Right” shall have the meaning set forth in Section 2.2(a).
“Non-controlling Party” shall have the meaning set forth in Section 10.4.
“Party” and “Parties” shall have the meaning set forth in the preamble.
“Patent Coordination Team” shall have the meaning set forth in Section 2.6(c).
“Payment Product” means any Licensed Product or any pharmaceutical product containing a RET inhibitor compound that is Covered by a Transferred Patent.
“Permitted Encumbrances” means (i) Liens approved in writing by Purchaser prior to Closing; (ii) statutory Liens arising out of operation of Law with respect to a Liability incurred in the ordinary course of business and which is not delinquent; (iii) Liens for Taxes not yet subject to penalties for nonpayment or that are being contested in good faith by appropriate proceedings; (iv) mechanics’, materialmens’, carriers’, workmens’, warehousemens’, repairmens’, landlords’ or other like Liens and security obligations that are not delinquent; (v) Liens arising under original purchase price conditional sales contracts with third parties entered into in the ordinary course of business; (vi) restrictions under leases, subleases, licenses or occupancy agreements that are Purchased Assets; (vii) Liens pursuant to any Assumed Contract; and (viii) all matters of record or otherwise disclosed in any title policy and/or survey provided by Seller to Purchaser or otherwise obtained by Purchaser or that an inspection or survey would disclose.
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“Person” means an individual, a limited liability company, joint venture, a corporation, a partnership, an association, a trust, governmental entity, a division or operating group of any of the foregoing or other entity or organization.
“Personal Information” means, with respect to any Person, any information that allows for identification of such Person and that is defined as “personal data,” “personally identifiable information,” “personal information” and is regulated by applicable Privacy Laws.
“Post-Closing Tax Period” means any Tax period (or portion thereof) beginning after the Closing Date.
“Pre-Closing Tax Period” means any Tax period (or portion thereof) ending on or before the Closing Date.
“PRC” shall have the meaning set forth in Section 7.6(g).
“Privacy Laws” means all applicable Laws that regulate privacy and security of Personal Information.
“Product” means the pharmaceutical product known as GAVRETO® (pralsetinib).
“Product Data” means all of the following, to the extent included in one or more Product Registrations and exclusively related to the Territory: (a) clinical data, results (including all tables, listing and graphs) and reports, case reports, and other written materials or correspondence filed with or received from a Governmental Authority, (b) records and data necessary to manufacture, formulate, test, package and store the Compound including (i) Compound and raw material specifications, (ii) standard operating procedures and master batch records and related manufacturing, engineering or other manuals as applicable, (iii) process validation reports and process development reports, (iv) technical storage conditions and stability assay procedures and other assay procedures, (v) quality control and release testing procedures and records, (vi) batch documentation including copies of executed batch records and disposition packages for the inventory set forth in the Material Transfer Agreement, in any form whatsoever, including relevant portions of laboratory notebooks or electronic files, and (vii) scientific reports owned by Seller related to the Compound.
“Product Registrations” shall have the meaning set forth in Section 5.9(a).
“Public Official” means (i) any official or employee of any Governmental Authority, including officials and employees who are appointed, elected or hired at any level within the legislative, administrative, executive, judicial or regulatory bodies of a national, regional or local government (e.g., military personnel, police, judges, inspectors, licensing officers, customs agents); (ii) any director, officer or employee at any level of any company, legal entity or other instrumentality owned or controlled by a Governmental Authority; (iii) any director, officer or employee at any level of public international organizations (e.g., the United Nations, the World Bank, the International Monetary Fund); (iv) any third party acting in an official capacity for a Governmental Authority or enterprise owned or controlled by a Governmental Authority (e.g., a third party acting under a delegation of authority to conduct government functions); (v) any political party, any official of a political party or any candidate for political office; or (vi) any member of a royal or ruling family.
“Purchase Price” means Fifteen Million Dollars ($15,000,000).
“Purchased Assets” shall have the meaning set forth in Section 2.1, it being understood that the Purchased Assets do not include the Excluded Assets.
“Purchaser” shall have the meaning set forth in the preamble.
“Purchaser Fundamental Representation” means the representations and warranties of Purchaser set forth in [***].
“Purchaser Indemnified Party” shall have the meaning set forth in Section 10.3(a).
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“Registered Intellectual Property” means all issued patents, registered trademarks and registered domain names and all applications for the foregoing included in the Transferred Intellectual Property.
“Regulatory Approval” means the approval, license, registration or authorization of the applicable Regulatory Authority necessary for the marketing and sale of the Product in a country or jurisdiction. Regulatory Approvals include approvals by Regulatory Authorities of NDAs.
“Regulatory Authority” means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the clinical development, manufacture, marketing or sale of the Product in a country or region, including the FDA in the United States.
“Regulatory Data” means any and all research data, pharmacology data, CMC data, safety data, nonclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with Regulatory Filings and Regulatory Approvals for the Product (including any applicable DMFs or similar documentation).
“Regulatory Filing” means any documentation comprising or relating to or supporting any submission or application with any Regulatory Authority in the Territory with respect to the Product or its use or potential use in humans, including any documents submitted to any Regulatory Authority, including INDs and NDAs, and copies of all correspondence with any Regulatory Authority with respect to the Product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).
“Representatives” means, in respect of a Party, any Affiliates and/or any directors, officers, employees, agents, contractors and/or advisors (including financial advisors, counsels, consultants and accountants) of such Party or any of its Affiliates.
“Retained Liabilities” shall have the meaning set forth in Section 2.5.
“Roche” means, collectively, F. Hoffmann-La Roche Ltd and Genentech, Inc. (“Genentech”).
“Roche Collaboration Agreement” means the Collaboration Agreement by and between Seller and Roche dated as of July 13, 2020.
[***]
“ROW Territory” means worldwide, excluding the Territory and the CStone Territory.
“Royalty Payments” shall have the meaning set forth in Section 3.2(d)(i).
“Royalty Reduction Trigger” shall have the meaning set forth in Section 3.2(d)(iv)(3).
“Royalty Report” shall have the meaning set forth in Section 3.2(d)(iii).
“Royalty Term” shall have the meaning set forth in Section 3.2(d)(ii).
“Sales Milestone Event” shall have the meaning set forth in Section 3.2(a)(ii).
“Seller” shall have the meaning set forth in the preamble.
“Seller Financing Agreement” means that certain Financing Agreement, dated as of June 30, 2022, by and among Seller, certain subsidiaries of Seller as guarantors, the lenders from time to time party thereto and Tao Talents, LLC, as administrative agent.
“Seller Fundamental Representation” means the representations and warranties of Seller set forth in [***].
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“Seller Indemnified Party” shall have the meaning set forth in Section 10.3(b).
“Seller Intellectual Property” means any Excluded Intellectual Property that [***]. The patents within the Seller Intellectual Property existing as of the Closing Date are set forth in Section 1.1 of the Disclosure Schedule. Notwithstanding anything to the contrary herein, the Seller Intellectual Property shall exclude [***].
“Solvent”, when used with respect to any Person, means that, as of any date of determination, (a) the amount of the “fair saleable value” of the assets of such Person on a going concern basis will, as of such date, exceed (i) the value of all “liabilities of such Person, including contingent and other liabilities” as of such date, as such quoted terms are generally determined in accordance with applicable United States federal laws governing determinations of the insolvency of debtors and (ii) the amount that will be required to pay the probable liabilities of such Person on its existing debts (including contingent liabilities) as such debts become absolute and matured, (b) such Person will not have, as of such date, an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged following such date and (c) such Person will be able to pay its liabilities, including contingent and other liabilities, as they mature. For purposes of this definition, each of the phrases “not have an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged” and “able to pay its liabilities, including contingent and other liabilities, as they mature” means that such Person will be able to generate enough cash from operations, asset dispositions or refinancing, or a combination thereof, to meet its obligations as they become due.
“Subsidiary” means an entity as to which Seller or Purchaser or any other relevant entity, as the case may be, owns directly or indirectly fifty percent (50%) or more of the voting power or other similar interests. Any Person which comes within this definition as of the date of this Agreement but thereafter fails to meet such definition shall from and after such time not be deemed to be a Subsidiary of Seller or Purchaser or any other relevant entity, as the case may be. Similarly, any Person which does not come within such definition as of the date of this Agreement but which thereafter meets such definition shall from and after such time be deemed to be a Subsidiary of Seller or Purchaser or any other relevant entity, as the case may be.
“Tax” or “Taxes” means all taxes, including income, excise, property, ad valorem, sales or use, value added, profits, license, withholding, payroll, employment, net worth, capital gains, transfer, stamp, social security, environmental, occupation and franchise taxes imposed by any Taxing Authority, together with any interest, penalties and additions to tax attributable thereto.
“Tax Return” or “Tax Returns” means any return, report, declaration, information return, statement or other document filed or required to be filed with any Taxing Authority, in connection with the determination, assessment or collection of any Tax.
“Taxing Authority” means any Governmental Authority exercising any authority to impose, regulate or administer the imposition of Taxes.
“Territory” means the United States.
“Third Party” means any Person who is not a Party. “Third Party” shall not include any Affiliate of a Party, except where the context otherwise requires.
“Transaction” shall have the meaning set forth in the Recitals.
“Transfer of Booking of Sales” means the point in time at which the First Commercial Sale occurs.
“Transfer Taxes” means any sales, use, excise, transfer, value added, conveyance, documentary transfer, stamp, recording, registration or other similar Tax (including any notarial fee) imposed in connection with, or otherwise relating to, the transactions contemplated by this Agreement or the recording of any sale, transfer or assignment of property (or any interest therein) effected pursuant to this Agreement.
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“Transferred Books and Records” means, subject to Section 2.3, all current and historical books, and records owned by Seller or its Affiliates, in whatever form kept, including electronic form, exclusively related to the Product in the Territory or primarily related to the Product in the Territory and reasonably necessary for the development, commercialization, Manufacturing, packaging, distributing, marketing and selling of the Product in the Territory, including but not limited to all technological, scientific, chemical, biological, pharmacological, toxicological and regulatory material and information primarily related to the Product in the Territory or otherwise reasonably necessary for the development, commercialization, Manufacturing, packaging, distributing, marketing and selling of the Product, including records related to past price increases (exclusively with respect to the Product in the Territory) and records that are exclusively related to the Product in the Territory and are necessary or useful for Purchaser in its compliance with the Inflation Reduction Act; provided, however, that the Transferred Books and Records shall not include (a) invoices and government claims, (b) books or records that are subject to restrictions on transfer pursuant to applicable Law regarding personally identifiable information or subject to privacy policies regarding personally identifiable information, (c) Tax Returns of Seller or its Affiliates (or their respective beneficial owners) or any Tax-related documentation or records, other than any Tax documentation or records exclusively related to the Business, (d) personnel files for employees of Seller or its Affiliates or (e) any records relating to the negotiation and consummation of the transactions contemplated by this Agreement or any of the Ancillary Agreements, including (i) communications with Third Parties and analyses relating to such transactions and (ii) communications with legal counsel representing Seller or any of its Affiliates or their respective licensees. For clarity “Transferred Books and Records” shall not include “Product Data” or “Regulatory Data”.
“Transferred Domain Names” means the internet domain names that are listed on Section 5.10(a) of the Disclosure Schedule.
“Transferred Intellectual Property” means, collectively, (a) the Transferred Domain Names, the Transferred Know-How, Transferred Marks, the Transferred Patents, and Transferred Regulatory Data, and (b) all copyrights in the Territory owned by Seller that are solely related to the Product, RET inhibitor compounds claimed or covered by the Transferred Patents.
“Transferred Know-How” means all information, inventions (whether patentable or not), know-how and data owned by Seller and/or its Affiliates and relating exclusively to the Product in the Territory, including, scientific and regulatory know-how, instructions, trade secrets, processes, formulae, product specifications, finished goods analytical test methods, stability data, Manufacturing and quality control data for finished products, but excluding any information, know-how, data and/or other above-referred assets which relate to Excluded Assets.
“Transferred Marks” means the marks that are listed on Section 5.10(a) of the Disclosure Schedule.
“Transferred Patents” means the patent registrations and applications listed on Section 5.10(a) of the Disclosure Schedule.
“Transferred Regulatory Data” means all Regulatory Data owned by Seller and/or its Affiliates for the Product in the Territory.
“Transferred Regulatory Filings and Approvals” means the Regulatory Filings and the Regulatory Approvals listed on Section 2.1(f) of the Disclosure Schedule.
“Transition Agreement” shall have the meaning set forth in Section 4.1(b)(v).
“Upfront Purchase Price” means Ten Million Dollars ($10,000,000).
“Valid Claim” means, with respect to a particular country, a claim of (a) an issued and unexpired patent (or a supplementary protection certificate or foreign equivalent thereof) that has not (i) irretrievably lapsed or been abandoned, permanently revoked, dedicated to the public or disclaimed or (ii) been held invalid, unenforceable or not patentable by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, which holding, finding or decision is final and unappealable or unappealed within the time allowed for appeal or (b) a pending patent application, which claim has not been abandoned or finally disallowed
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without the possibility of appeal; provided that, if a pending patent application has been pending for longer than [***] from the date of filing of the initial priority application, then such corresponding claim in such pending patent application will not be deemed to be a Valid Claim; provided that, if a claim ceases to be a Valid Claim by reason of the foregoing subclause (b), then such claim will again be deemed a Valid Claim in the event such claim subsequently issues prior to the end of the Royalty Term in such country.
(a)The words “hereof”, “herein”, “hereto” and “hereunder” and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.
(b)The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.
(c)The terms “dollars” and “$” shall mean United States of America dollars.
(d)The term “including” shall mean “including, without limitation.”
(e)When a reference is made in this Agreement to an Article, a Section, an Exhibit or Schedule, such reference shall be to an Article of, a Section of, or an Exhibit or Schedule to, this Agreement unless otherwise indicated.
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Notwithstanding anything to the contrary in this Agreement, the Purchased Assets shall not include any Excluded Assets.
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Development Milestone Event | Development Milestone Payment | |
---|---|---|
1 | [***] | [***] |
2 | [***] | [***] |
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Upon the first achievement of Calendar Year cumulative annual Net Sales of all Payment Products in the Territory | Milestone Payment | |
---|---|---|
1 | [***] | [***] |
2 | [***] | [***] |
3 | [***] | [***] |
4 | [***] | [***] |
5 | [***] | [***] |
Calendar Year Cumulative Annual Net Sales of all Payment | Royalty |
---|---|
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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Except as set forth in the disclosure schedule attached hereto as Exhibit C (the “Disclosure Schedule”), Seller hereby represents and warrants to Purchaser the following, in each case as of the date hereof:
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Except as set forth on each Disclosure Schedule attached hereto that relates to such Section of this Agreement or in another Disclosure Schedule to the extent that it is reasonably apparent on the face of such disclosure that such disclosure is applicable to such Section of this Agreement, Purchaser hereby represents and warrants to Seller as follows:
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which Purchaser and any of its Affiliates is a party or is subject; or (c) assuming compliance with the matters set forth in Sections 5.5 and 6.5, violate or result in a breach of or constitute a default under any Law or other restriction of any Governmental Authority to which Purchaser is subject except, with respect to clauses (b) through (c), for any violations, breaches, conflicts, defaults, terminations, cancellations or accelerations as would not, individually or in the aggregate, reasonably be expected to prevent or materially delay the consummation of the transactions contemplated hereby.
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(including any Tax related purpose), have access during normal business hours to examine, inspect and copy such books and records. During such [***] or longer period, Purchaser shall provide, or cause to be provided to, Seller or its Affiliates access to such original books and records related to the development, commercialization, manufacturing, packaging, distributing, marketing and selling of the Product as Seller or its Affiliates shall reasonably request in connection with any Legal Proceeding to which Seller or any of its Affiliates are parties or in connection with the requirements of any Law applicable to Seller or any of its Affiliates. Seller or its Affiliates, as applicable, shall return such original books and records to Purchaser or such Affiliate as soon as such books and records are no longer needed in connection with the circumstances described in the immediately preceding sentence. After such [***] or longer period, before Purchaser or any Affiliate shall dispose of any of such books and records, Purchaser shall give at least [***] prior written notice of such intention to dispose to Seller, and Seller or any of its Affiliates shall be given an opportunity, at their cost and expense, to remove and retain all or any part of such books and records as it may elect. If so requested by Purchaser, Seller or its Affiliate, as applicable, shall enter into a customary joint defense agreement with Purchaser or such Affiliate with respect to any information to be provided to such Seller or its Affiliate pursuant to this Section 7.1.
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measures (and Seller shall reasonably cooperate, at the expense of Purchaser, in the taking of such measures) to preserve the confidentiality of such information.
After the Closing, Purchaser and Seller shall negotiate in good faith with each other and with Roche and CStone a safety data exchange agreement related to the Product as soon as practicable, and in any event within [***] after the Closing.
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or
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To Seller:
Blueprint Medicines Corporation
45 Sidney Street
Cambridge, MA, USA 02139
Attention:Chief Executive Officer
Email:[***]
with a copy (which shall not constitute notice) to:
Blueprint Medicines Corporation
45 Sidney Street
Cambridge, MA, USA 02139
Attention:Chief Legal Officer
Email:[***]
and
Goodwin Procter LLP
100 Northern Avenue
Boston, MA, USA 02210
Attention:Kingsley Taft; Danielle Lauzon
Email:[***]
to Purchaser:
Rigel Pharmaceuticals, Inc.
611 Gateway Blvd.
Suite 900
South San Francisco, CA USA 94080
Attention:General Counsel
Email:[***]
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with a copy (which shall not constitute notice) to:
Sidley Austin LLP
555 California Street
Suite 2000
San Francisco, CA USA 94014
Attention:Carlton Fleming
Stephen Abreu
Email:[***]
[***]
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THAT EACH HAS REVIEWED THIS WAIVER WITH ITS OR HIS, AS THE CASE MAY BE, LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THE WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THE TRANSACTIONS CONTEMPLATED HEREBY. IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
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[signature page follows]
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IN WITNESS WHEREOF, the Parties have executed or caused this Agreement to be executed by their respective duly authorized representatives as of the date first written above.
BLUEPRINT MEDICINES CORPORATION
RIGEL PHARMACEUTICALS, INC.
[Signature Page to Asset Purchase Agreement]
This Bill of Sale and Assignment and Assumption Agreement (this “Bill of Sale”) is made as of [•] (the “Effective Date”), by and between Blueprint Medicines Corporation, a Delaware corporation (“Seller”), and Rigel Pharmaceuticals, Inc., a Delaware corporation (“Purchaser”).
WHEREAS, Seller and Purchaser entered into that certain Asset Purchase Agreement dated as of the date hereof, as may be amended from time to time (the “Asset Purchase Agreement”), pursuant to which, among other things, Seller has agreed to grant, sell, transfer, assign, convey and deliver to Purchaser, and Purchaser has agreed to purchase, acquire and assume from Seller, all of Seller’s right, title and interest to the product known as GAVRETO® (pralsetinib) in the United States and other Purchased Assets and Assumed Liabilities, in each case, on the terms and subject to the conditions set forth in the Asset Purchase Agreement.
NOW, THEREFORE, pursuant and subject to terms of the Asset Purchase Agreement and in consideration of the mutual covenants set forth herein and in the Asset Purchase Agreement, and other good and valuable consideration as set forth in the Asset Purchase Agreement, the receipt and sufficiency of which is hereby acknowledged, Seller and Purchaser agree as follows:
This Intellectual Property Assignment Agreement (“IP Assignment Agreement”) is made as of [•] (the “Effective Date”), by and between Blueprint Medicines Corporation, a Delaware corporation (“Assignor”), and Rigel Pharmaceuticals, Inc., a Delaware corporation (“Assignee”).
WHEREAS, Assignor and Assignee entered into that certain Asset Purchase Agreement dated [•], as may be amended from time to time (the “Asset Purchase Agreement”); and
WHEREAS, Assignee is desirous of acquiring, in connection with the transactions contemplated by the Asset Purchase Agreement, the entire right, title and interest in and to the assets set forth in Section 2 of this IP Assignment Agreement.
NOW, THEREFORE, subject to the terms and conditions set forth in the Asset Purchase Agreement and in consideration of the premises and other good and valuable consideration as set forth in the Asset Purchase Agreement, the receipt and sufficiency of which are hereby acknowledged, Assignor and Assignee hereby agree as follows:
[Signature page follows.]
Schedule A
Intellectual Property (Transferred Patents, Transferred Marks and Transferred Domain Names)
[***]
[***]
TRANSITION AGREEMENT
This Transition Agreement (this “Agreement”) is made and entered into as of the [•] day of [•] (the “Effective Date”), between Blueprint Medicines Corporation, a Delaware corporation (“Seller”), and Rigel Pharmaceuticals, Inc., a Delaware corporation (“Purchaser”). Seller and Purchaser are individually referred to as a “Party” and collectively as the “Parties.” Capitalized terms used and not otherwise defined in this Agreement shall have the respective meanings set forth in the Asset Purchase Agreement (as defined below).
WHEREAS, Seller previously entered into a Collaboration Agreement dated as of July 13, 2020 (the “Roche Collaboration Agreement”) by and among Seller, F. Hoffmann-La Roche Ltd (“Roche Basel”), and Genentech, Inc. (“Genentech” and together with Roche Basel, “Roche”) for the development and commercialization of GAVRETO® (pralsetinib) globally (excluding the People’s Republic of China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan); and
WHEREAS, pursuant to the Roche Collaboration Agreement, as of the Effective Date (i) Genentech holds the NDA for the Product and is booking sales of the Product in the United States, and (ii) Roche holds the global safety database for the Product and manufactures the Product globally; and
WHEREAS, the Roche Collaboration Agreement was terminated effective as of [•]; and
WHEREAS, in connection with the termination of the Roche Collaboration Agreement, Seller and Roche have [***]; and
WHEREAS, Seller and Purchaser entered into an Asset Purchase Agreement dated as of the date hereof (the “Asset Purchase Agreement”) pursuant to which Purchaser has purchased and assumed all of Seller’s right, title and interest to the Product in the United States on the terms and conditions set forth therein; and
WHEREAS, pursuant to Section 4.1(b)(v) of the Asset Purchase Agreement, the Parties desire to agree upon certain terms and conditions to enable an orderly transition of certain assets and responsibilities related to the Product, including without limitation an orderly transition of the booking of sales of the Product in the United States from Genentech to Purchaser;
NOW THEREFORE, Seller and Purchaser hereby agree as follows:
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[Signature page follows]
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Schedule 1
[***]
EXHIBIT E
FORM OF MATERIAL TRANSFER AGREEMENT
MATERIAL TRANSFER AGREEMENT
between
Blueprint Medicines Corporation
45 Sidney Street
Cambridge
MA 02139
(hereinafter called “BPM”)
and
Rigel Pharmaceuticals, Inc.
611 Gateway Blvd.
Suite 900
South San Francisco, CA USA 94080
(hereinafter called “Rigel”)
[***]
Appendix A: Transition price
[***]
Appendix B: Quality Agreement pertaining to Lots in Appendix A only
[***]
Appendix C: Product Specification for US Markets
[***]
Appendix D: List of Contact Persons
Contact Persons (including, but not limited to Notices of Amendment, Assignment, Termination, Deviation Reports, Complaints, Recall, Resolution of Quality Issues) |
[***]
Appendix E: Required Documents for Product
Documents required for release of Product
[***]