AMENDED AND RESTATED DEVELOPMENT SERVICES AND CLINICAL SUPPLY AGREEMENT by and between PASSAGE BIO, INC. and CATALENT MARYLAND, INC. Dated as of November 9, 2023
Exhibit 10.26
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO PASSAGE BIO, INC. IF PUBLICLY DISCLOSED.
EXECUTION VERSION
AMENDED AND RESTATED
DEVELOPMENT SERVICES AND CLINICAL SUPPLY AGREEMENT
by and between
and
CATALENT MARYLAND, INC.
Dated as of November 9, 2023
EXECUTION VERSION
TABLE OF CONTENTS
Page
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Exhibits
ADefinitions
BScope of Work
CBatch Ordering and Forecasting Requirements
DApproved Subcontractors
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Amended and restated DEVELOPMENT SERVICES AND CLINICAL SUPPLY AGREEMENT
THIS AMENDED AND RESTATED DEVELOPMENT SERVICES AND CLINICAL SUPPLY AGREEMENT (this “Agreement”), dated as of the 9th day of November, 2023, (the “Amendment Effective Date”), is entered into by and between PASSAGE BIO, INC., a corporation organized and existing under the Laws of Delaware and having a place of business at One Commerce Square, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (“Passage Bio”), and CATALENT MARYLAND, INC. (formerly PARAGON BIOSERVICES, INC.), a corporation organized and existing under the Laws of Delaware and having a place of business at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (“Catalent”). Passage Bio and Catalent are sometimes referred to herein, individually, as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Passage Bio is an integrated genetic medicines company that is currently developing a portfolio of live transforming Adeno-associated virus (“AAV”)-delivered therapeutics for the treatment of rare monogenic central nervous system diseases, and Passage Bio is interested in securing process development services and clinical scale manufacturing capacity for such products and other drugs of which Passage Bio or its designated Affiliates or Strategic Partners may later contract with Catalent for clinical supply;
WHEREAS, Catalent has process development, manufacturing, and related services experience and expertise, and operates facilities for the development and manufacturing of biopharmaceuticals, including a commercial scale biomanufacturing facility located at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ (the “BWI Facility”);
WHEREAS, Passage Bio and Catalent are parties to that certain Collaboration Agreement dated as of June 28, 2019, pursuant to which Catalent committed to provide Passage Bio with dedicated biomanufacturing space at the BWI Facility and, subject to future agreements, to perform clinical and commercial supply of Passage Bio Products (the “Original Collaboration Agreement”);
WHEREAS, Passage Bio and Catalent are parties to that certain Development Services and Clinical Supply Agreement dated as of April 13, 2020 (the “Effective Date”), pursuant to which Catalent provides certain development services and clinical supply manufacturing of batches of certain bulk drug substances and products for Passage Bio (the “Original DSCSA”; and together with the Original Collaboration Agreement, the “Prior Agreements”);
WHEREAS, Passage Bio and Catalent entered into those two certain letter agreements on March 31, 2023 (“Side Letter Agreement I” and “Side Letter Agreement II”, collectively, the “Letter Agreements”), pursuant to which the Parties agreed upon certain amendments to the Original Collaboration Agreement and the Original DSCSA;
WHEREAS, Passage Bio and Catalent have entered into that certain ▇▇▇▇▇▇▇ and Restated Collaboration Agreement of even date herewith (the “Collaboration Agreement”), which
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supersedes the Original Collaboration Agreement, to reflect and incorporate the terms of the Letter Agreements; and
WHEREAS, Passage Bio and Catalent now desire to amend and restate the Original DSCSA in accordance with Side Letter II, to reflect and incorporate the terms of the Letter Agreements.
NOW, THEREFORE, in consideration of the foregoing and the representations, warranties, covenants, agreements and provisions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties agree as follows:
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to meet the timelines set forth in the Scope of Work. Unless otherwise agreed by the Parties in the Scope of Work, the Process Performance Qualification will be completed upon Catalent’s completion of [*]. The date upon which a final report confirming the completion of these PPQ activities has been submitted by Catalent and approved by Passage Bio shall be referred to herein as the “PPQ Completion Date.” Passage Bio’s approval of the completion of the PPQ activities shall not be unreasonably withheld or delayed.
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Wire transfer:
Account Name[*]
ABA#:[*]
Account#:[*]
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samples, in the event of a complaint or query arising in respect of Bulk Drug Substance and Drug Product. Such records and samples shall be retained by Catalent for a period of [*] from the time they were made or taken or, alternatively, delivered to Passage Bio, or such longer period as required by Applicable Laws.
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Materials, subject to and after giving effect to Passage Bio’s right to use such establishment license approvals in connection with its Development, Manufacturing and Commercialization activities for the Manufacture of Bulk Drug Substance and/or Drug Product.
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regarding matters that may affect or involve operations or other activities associated Passage Bio Products.
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The Receiving Party has the burden of proving any of the above exceptions. The Disclosing Party has the right to inspect the Receiving Party’s documentary evidence upon which the Receiving Party bases its claim that Confidential Information is within any of the above exceptions.
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any document filed with any Regulatory Authority or Governmental Authority, including the FDA, EMA and the Securities and Exchange Commission.
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incorporate or utilize Passage Bio Confidential Information, Passage Bio Intellectual Property, or Passage Bio Products, shall be “Catalent Arising IP” and Catalent shall own all right, title and interest therein. Catalent hereby grants to Passage Bio an irrevocable, perpetual, transferrable, fully paid, non-exclusive, worldwide license, with the right to grant and authorize sublicenses, to practice Catalent Arising IP, and to practice any Catalent Intellectual Property to the extent necessary to practice such Catalent Arising IP, for the sole and limited purposes of Development, Manufacturing, Commercialization and use, by or on behalf of Passage Bio or a Passage Bio sublicensee, of the Passage Bio Products.
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Bio Arising IP or the Catalent Arising IP upon request of the relevant Party ( collectively, the “Arising IP Patents”), including obtaining and executing necessary powers of attorney and assignments by the named inventors, providing relevant technical reports to the filing Party concerning Inventions disclosed in such Arising IP Patents, obtaining execution of such other documents which are needed in the filing and prosecution of such Arising IP Patents. The Parties shall cooperate reasonably in the prosecution of all Arising IP Patents.
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except to the extent in each case that the Loss in question resulted from the gross negligence or willful misconduct of, or material breach of this Agreement by, a Passage Bio Indemnitee or any of its or their Representatives. Catalent’s obligation to defend, indemnify and hold harmless a Passage Bio Indemnitee hereunder is subject to the limitation of liability set forth in Section 20.2(g).
except to the extent in each case that the Loss in question resulted from the gross negligence or willful misconduct of, or material breach of this Agreement by, a Catalent Indemnitee or any of its or their Representatives.
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Indemnifying Party shall not settle any claim without (a) first consulting with the Indemnified Party, and (b) obtaining the prior written consent of the Indemnified Party, not to be unreasonably withheld or delayed, unless the settlement involves only the payment of money. The Indemnified Party shall not settle or compromise any such claim without (x) first consulting with the Indemnifying Party, and (y) obtaining the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (i) the Indemnified Party may, using counsel of its choice, defend against such claim in any manner the Indemnified Party may deem reasonably appropriate, and (ii) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Article XVIII, provided, that in such instance such indemnity shall also include the reasonable and documented legal fees and reasonable out-of-pocket costs incurred by the Indemnified Party in connection with so defending itself in the absence of a defense being provided by the Indemnifying Party.
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Exclusivity
. There is an exclusive relationship between Catalent and Passage Bio with regard to the manufacture of clinical supply of Bulk Drug Substance and Drug Product, in each case, only with respect to Passage Bio Active Products. Catalent shall use its best efforts to manufacture such requirements for clinical supplies of Bulk Drug Substance and Drug Substance.
. With respect to each Passage Bio Active Product, the exclusive relationship described in Section 19.1 will convert to a non-exclusive relationship upon the occurrence of any of the following:
Divestiture Event | Divestiture Fee |
Divestiture Event involving [*] (the “Divestiture Event A”) | US $[*] |
Divestiture Event involving [*] (the “Divestiture Event B”) | US $[*] |
Divestiture Event involving [*] (the “Divestiture Event C”) | US $[*] |
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course of dispute resolution pursuant to the provisions of Section 21.2, except as provided for in Section 2.4 or to the extent such commitments are the subject of such dispute, controversy or claim.
If to Passage BioPassage Bio, Inc.
Attn: CEO
2005 Market Street, 39th floor
Philadelphia, Pennsylvania 19103
Telephone: [*]
Email: [*]
with a copy to:
Attn: General Counsel
2005 Market Street, 39th floor
Philadelphia, Pennsylvania 19103
Telephone:
Email: [*]
If to CatalentCatalent Maryland, Inc.
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Attn: PresidentGene Therapy
▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
Baltimore, Maryland 21201
Telephone: [*]
Email: [*]
with a copy to:
Catalent Pharma Solutions, LLC
▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇
Somerset, NJ 08873 USA
Attn: General Counsel (Legal Department)
E-Mail: [*]
Facsimile: [*]
provided, however, that if any Party shall have designated a different address by notice to the others, then to the last address so designated.
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application of any Law other than the Laws of the State of Delaware. The Parties hereto agree that a final judgment in any such action shall be conclusive and, notwithstanding anything to the contrary, may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by ▇▇▇. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their respective duly authorized officers as of the date first above written.
By: /s/ ▇▇▇▇ ▇▇▇▇, M.D.
Name: ▇▇▇▇ ▇▇▇▇, M.D.
Title: CEO
CATALENT MARYLAND, INC.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Title: VP, Global Head of Gene Therapy
[Signature page to Amended and Restated Development and Clinical and Commercial Supply Agreement]
EXHIBIT A
DEFINITIONS
This Exhibit A provides agreed upon definitions applicable to the Parties for purposes of this Agreement.
| 1.1 | Definitions. |
“Additional Raw Materials Cost” means the costs of the Raw Materials procured by Catalent associated with the re-Manufacture or Reprocessing of a Failed Batch or Defective Batch of Drug Product or Bulk Drug Substance under Section 8.6, which costs are comprised of (a) with respect to Drug Product, the cost of any additional Raw Materials necessary for the supply of any substitute Bulk Drug Substance that must be replaced therefor and the cost of any other additional Raw Materials necessary for Manufacture of the new Batch or to Reprocess the current Batch of Drug Product; and (b) with respect to Bulk Drug Substance, the cost for the supply of Raw Materials necessary to Manufacture a new Batch or Reprocess the current Batch of Bulk Drug Substance. Additional Raw Materials Cost does not include the costs for Passage Bio Materials.
“Affiliate” means, with respect to Passage Bio or any Third Party, any corporation, firm, partnership or other entity that controls, is controlled by or is under common control with such entity; and with respect to Catalent, CPS or any other corporation, firm, partnership or other entity that controls, is controlled by or is under common control with CPS. For the purposes of this definition, “control” means the ownership of at least 50% of the voting share capital of an entity or any other comparable equity or ownership interest.
“Applicable Law(s)” means, with respect to Passage Bio, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of each jurisdiction in which the Passage Bio Product is produced, marketed, distributed, used or sold; and with respect to Catalent, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in which Catalent performs Services, including cGMPs if applicable.
“Batch” means a specific quantity of any Passage Bio Products Bulk Drug Substance or Drug Product, as applicable in the given context, that is intended to have uniform character and quality within specified limits and is produced according to a single cycle of Manufacture.
“Batch Record” means a manufacturing record for a Batch generated by Catalent concurrently with the production of a specific Batch such that successive steps in such processes are documented.
“Bill of Materials” shall mean the list of Raw Materials prepared by Catalent and approved by Passage Bio necessary for and to be consumed or used during the Manufacture of Batches of Bulk Drug Substance or Drug Product.
“Bio-Park Facility” shall mean the product development and clinical supply manufacturing facility located at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇.
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“BLA” means a Biologics License Application (or successor or equivalent application) (including all supplements, amendments, and modifications thereof) for authorization for marketing of a biologic product, as defined in the Applicable Laws and regulations and filed with applicable Regulatory Authorities.
“Bulk Drug Substance” means the active pharmaceutical ingredients of the Passage Bio Products being Manufactured by Catalent in bulk form and prior to any formulation, filling, and finishing.
“Business Day” means a day other than a Saturday, Sunday, or other day on which commercial banks in New York are authorized or required by Law to be closed for business.
“BWI Facility” shall mean the commercial scale biomanufacturing facility located at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇.
“Catalent Intellectual Property” means any Intellectual Property owned or Controlled by Catalent prior to the Effective Date, or otherwise arising outside the performance of this Agreement, without reliance on or reference to any Passage Bio Confidential Information.
“Cell Line” means the cell line licensed to or used by Passage Bio for the Manufacture of the Passage Bio Products and any derivatives, modifications or progeny thereof.
“Certificate of Analysis” means a written certificate issued by Catalent listing the items tested, the Specifications, testing methods and test results for a specific Batch.
“Certificate of Compliance” means a written certificate issued by Catalent, in a form approved by the Parties and executed by Catalent’s quality assurance department, certifying that each Batch has been Manufactured in accordance with and satisfies the Product Requirements.
“Commercialize,” “Commercializing” or “Commercialization” means all activities directed to the marketing (whether through direct, in-person, electronic or other marketing channels), promotion, selling or offering for sale of a product for an indication, including planning, market research, pre-marketing activities undertaken in preparation for launch, advertising, educating, marketing, promoting, importing, exporting, distributing and post-marketing safety surveillance and reporting. For clarity, “Commercialize,” “Commercializing” or “Commercialization” shall not include any activities included within the Manufacturing or Development of a product.
“Control,” “Controls,” “Controlled” means, when used in reference to intellectual property, other intangible property, or materials, that a Party owns or has a license or sublicense to such intellectual property, other intangible property or materials, and has the ability to grant a license or sublicense or other right to use such intellectual property, other intangible property or materials, as applicable, as provided for herein, without (i) requiring the consent of a Third Party or (ii) violating the terms of any agreement or other arrangement with any Third Party.
“Cover,” “Covering,” “Covered” means, with respect to a country in the Territory, but for a license granted under a valid claim of a Patent, the use or sale, or offer for sale in such country of the subject matter at issue would infringe such valid claim, or in the case of a Patent that is a
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Patent application, would infringe a valid claim in such Patent application if it were to issue as a Patent.
“Defect” means, with respect to a Batch, a defect that causes the Batch to fail to conform to the Specifications or otherwise cannot be used due to the failure of the Batch to meet the Product Requirements, and which is (a) discovered by Passage Bio upon review of the Batch Documentation or Actual Passage Bio Receipt of the Batch or (b) a Latent Defect.
“Develop,” “Developing,” “Development” means any and all activities relating to research, non-clinical, preclinical and clinical trials, toxicology testing, statistical analysis, publication and presentation of research and study results and reporting, process and analytical development, analytical testing, preparation and submission of applications (including any CMC-related information) for regulatory approval of a product, necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining all regulatory approvals for such product. For clarity, “Development” shall not include any activities included within the Manufacturing of a product.
“Drug Master File” means submissions to FDA ( or its equivalent) used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products formulated mixture of the Bulk Drug Substance and any excipients, finished and filled in final marketed dosage form.
“Drug Product” means the formulated mixture of the Bulk Drug Substance and any excipients, finished and filled in final marketed dosage form.
“EMA” means the European Medicines Agency or its successor.
“EU” means the countries of the European Union as it exists at any time.
“FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.
“FDA” means the U.S. Food and Drug Administration or its successor.
“Fiscal Year” or “FY” means the calendar year commencing on January 1 and concluding on December 31.
“GAAP” means the United States generally accepted accounting principles, as in effect from time to time, consistently applied.
“Good Manufacturing Practices,” “GMPs” or “cGMPs” means the then-current good manufacturing practices required by (i) the FDA, as set forth in the FD&C Act and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, including the provisions of 21 C.F.R. Parts 210 and 211, (ii) European Commission Directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively, as well as “The rules governing medicinal products in the European Union,” Volume 4, Guidelines for good manufacturing practices for medicinal products for human and veterinary use, and (iii) the principles detailed in the ICH Q7 A guidelines, in each case, including all applicable rules,
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regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto.
“Governmental Authority” means any multinational, federal, state, local, municipal or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal), in each case, having jurisdiction over the applicable subject matter in the Territory.
“Improvements” means all discoveries, Inventions, developments, modifications, innovations, updates, enhancements or improvements to Technology (whether or not protectable under Patent, trademark, copyright or similar Laws) that are conceived, discovered, invented, developed, created, made or reduced to practice in the performance of the Parties’ obligations under this Agreement.
“IND” means both the application of an Investigational New Drug Application to the FDA and its equivalent in other countries and their Regulatory Authorities, such as a clinical trial application or a clinical trial exemption, the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
“Invention” means any subject matter invented during the Term, whether or not recorded or recognized as such during the Term, by or on behalf of a Party or one or more of the Parties jointly, as determined in accordance with the provisions of U.S. patent Law governing inventions, in the performance of activities under this Agreement.
“Intellectual Property” means all information, data, works of authorship, discoveries, concepts, Technology, methods, Know-How, designs, processes, software, algorithms and inventions, whether patentable or not, including, without limitation, those that could be the subject of patent, copyright, industrial design, trade secret or other forms of protection; including, without limitation, all (i) Patents; (ii) trademark applications, registrations, service marks, domain names and all renewals and extensions thereto; and (iii) copyright applications and registrations and all restorations, reversions, renewals and extensions thereof.
“Know-How” means any proprietary data, results, material(s), and nonpublic information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, discoveries, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports and plans, market research, expertise (including experts’ information), test data (including pharmacological, biological, chemical, biochemical, toxicological, preclinical and clinical test data), analytical and quality control data, stability data, other study data and procedures.
“Latent Defect” means a Defect that is not discoverable upon inspection and analysis of the Batch Documentation or upon inspection using commercially reasonable efforts at the time of Actual Passage Bio Receipt, but is discovered at a later time.
“Laws” means, with respect to Passage Bio, all laws, statutes, rules, regulations, directives, decisions, ordinances, guidelines and other pronouncements of any Governmental Authority currently in effect or enacted or promulgated during the Term, and as amended from time to time,
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of each jurisdiction in which the Passage Bio Product is produced, marketed, distributed, used or sold; and with respect to Catalent all laws, statutes, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in which Catalent Manufactures the Passage Bio Product, including cGMP.
“Manufacture” or “Manufacturing” means all activities, whether performed by a Party or a Third Party designee of a Party, related to the manufacturing of a product, or any ingredient thereof, including document preparation, material acquisition/release, GMP suite activation, manufacturing for clinical use, formulation, filling and finishing activities, in process and product testing, release of product, quality assurance activities related to manufacturing and release of product, handling and storage of product and ongoing stability tests, packaging and labeling, and regulatory activities related to any of the foregoing.
“Manufacturing Configuration” means the Manufacturing process configuration for each Passage Bio Product involving [*], such configuration which may change from time to time.
“Manufacture/Release Period” means the period of time required for the manufacture, release and Approval of a Batch of Passage Bio Bulk Drug Substance, commencing on the first day of Manufacturing of the Batch and concluding on the Delivery of the Batch.
“Marketing Authorization” means an approval and authorization, including any renewals thereof, of the applicable Regulatory Authority necessary for the manufacture, packaging, marketing, storage, import, export, transport, distribution, sale and use of a pharmaceutical or biologic product in any country of the Territory.
“Marketing Authorization Application” or “MAA” means an application to the appropriate Regulatory Authority for approval to sell a Drug Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction, including such application filed with the EMA pursuant to the Centralized Procedure or with the applicable Regulatory Authority of a country in accordance with such country’s national approval procedure.
“Maximum Upstream Runs” means the maximum number of upstream production runs that can be completed during a Dedicated Manufacturing Period and is based on [*] that the Parties mutually agree can be safely and efficiently operated.
“Passage Bio Active Products” means Passage Bio’s portfolio [*].
“Passage Bio Products” means the Passage Bio live transforming AAV-delivered therapeutics for the treatment of rare monogenic central nervous system diseases and, in the future, other therapeutic products which Passage Bio or its designated Affiliates or Strategic Partners may develop. For clarity, “Passage Bio Products” includes the Passage Bio Active Products.
“Passage Bio Intellectual Property” means Passage Bio Patents, Passage Bio Technology and any Intellectual Property owned or Controlled by Passage Bio on or prior to the Effective Date, or otherwise arising outside the performance of this Agreement, without reliance on or reference to any Catalent Confidential Information.
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“Passage Bio Materials” means any or all of the materials, samples, compounds, including biological materials, master cell bank, working cell bank and/or research cell bank, the Cell Line, and the DNA plasmids, as made available to Catalent by or on behalf of Passage Bio or its successor in interest, as well as all information provided by or on behalf of Passage Bio concurrently therewith that specifically relates thereto.
“Passage Bio Patents” means any Patent that is owned or Controlled by Passage Bio as of the Effective Date or comes under the ownership or Control of Passage Bio during the Term and (i) is necessary for or useful to the Development, Manufacture, use or Commercialization of Passage Bio Products or (ii) relates to any Passage Bio Products. For purposes of this definition, Passage Bio shall not be deemed to Control any Patent that is licensed by Catalent to Passage Bio pursuant to this Agreement.
“Passage Bio Technology” means (i) any present and future Technology that is owned or Controlled by Passage Bio and necessary for or useful to the Development, Manufacture or Commercialization of Passage Bio Products and (ii) any Technology that is developed or obtained by or on behalf of Passage Bio related to Passage Bio Products, or the Manufacture of any of the foregoing, (a) prior to the Effective Date, or (b) independent of this Agreement and without the use of the Confidential Information of Catalent. Passage Bio Technology specifically includes any Passage Bio Materials. For purposes of this definition, Passage Bio shall not be deemed to Control any Technology that is licensed by Catalent to Passage Bio pursuant to this Agreement.
“Patent Term Extension” means any term extensions, supplementary protection certificates, Regulatory Exclusivity and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.
“Patents” means (i) all national, regional and international patents and patent applications, including provisional patent applications, (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (iii) any and all patents that have issued or in the future issue from the foregoing patent applications ((i) and (ii)), including utility models, ▇▇▇▇▇ patents and design patents and certificates of invention, (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, reexaminations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((i), (ii), and (iii)) and (v) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.
“Person” means any corporation, limited or general partnership, limited liability company, joint venture, trust, unincorporated association, governmental body, authority, bureau or agency, any other entity or body, or an individual.
“Pricing Approval” means the approval, agreement, determination or decision from a Governmental Authority establishing the price and/or reimbursement for a Passage Bio Product for sale in a given country of the Territory, as required by Applicable Laws in such country or
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other regulatory jurisdiction prior to the sale of the Passage Bio Product in such country or regulatory jurisdiction.
“Process Inherent Issues” means failures for which the Primary Cause is Passage Bio’s process technology, instructions, setpoints and/or Specifications for producing Batches of Bulk Drug Substance or Passage Bio Products, where such failures are inconsistent with historical trends of successful Batches or do not enable a transferable and suitable Manufacture of Batches of Bulk Drug Substance or Passage Bio Products to meet the Specifications.
“Procurement Costs” means the actual price paid by Catalent for the procurement of materials and supplies used in the Manufacture of Passage Bio Products. Procurement Costs do not include the Procurement Fee.
“Procurement Fee” means the fee that is paid to Catalent for its services in the procurement of materials and supplies used in the Manufacture of Passage Bio Products ( other than Passage Bio Materials), such fee being a certain percentage of the Procurement Costs. [*].
“Product Approval” means, with respect to a Drug Product, the approval of a Governmental Authority necessary for the marketing and sale in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).
“Product Requirements” shall mean, with respect to each Batch Manufactured pursuant to this Agreement, that such Batch shall: (a) conform to the applicable Specifications; (b) be manufactured, packaged, labeled, handled, and stored in compliance with Applicable Laws and the Quality Agreement; (c) contain only Raw Materials that have been used, handled or stored in accordance with the Storage Guidelines, Applicable Laws and the Quality Agreement; and ( d) not be adulterated or misbranded within the meaning of the FD&C Act, or within the meaning of any applicable state or municipal law in which the definitions of adulteration or misbranding are substantially the same as those contained in the FD&C Act, as such Act and such law are constituted and effective at the time of delivery and will not be an article which may not, under provisions of Sections 404, 505 or 512 of the FD&C Act, be introduced in interstate commerce.
“Purchase Order” means a written or electronic order form submitted by Passage Bio in accordance with the terms of this Agreement to Catalent authorizing the manufacture and supply of Bulk Drug Substance and/or Drug Product.
“Quality Agreement” means that certain Quality Agreement, [*], entered into by and between Passage Bio and Catalent. All references to Quality Agreement herein shall refer to the Quality Agreement in effect at the time of the Manufacture of the Passage Bio Products.
“Raw Materials” means all physical materials to be consumed in the Manufacture of Bulk Drug Substance or Drug Product or incorporated into Bulk Drug Substance or Drug Product or the packaging thereof, including process consumables, packaging materials, and components needed for the Manufacture of Bulk Drug Substance and/or Drug Product.
“Regulatory Acts” means any rules, regulations, directives, decisions, ordinances, guidelines and other pronouncements of any Regulatory Authority.
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“Regulatory Approvals” means, with respect to a Drug Product or a facility for the Manufacture of a Drug Product or component thereof, all filings and approvals (including, as applicable, IND filings, Product Approvals, Pricing Approvals, establishment license approvals and, in each case any supplements and amendments thereto), licenses, registrations or authorizations of any Governmental Authority necessary to obtain Marketing Authorization for or to Develop, Manufacture or Commercialize a Drug Product, as applicable, in the Territory.
“Regulatory Authority” means, any applicable Governmental Authority involved in granting Regulatory Approval in the Territory. In the United States, this includes the FDA and in the European Union, this includes the EMA.
“Regulatory Exclusivity” means, with respect to Drug Products, any exclusive marketing rights or data exclusivity rights conferred by any Governmental Authority with respect to the Drug Products other than a Patent right, including in the European Union, Regulation (EC) No 726/2004 and Directive 2001/83/EC (as amended).
“Regulatory Materials” means, with respect to Drug Products or the facilities used to Manufacture Drug Products or a component thereof, as applicable, regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority that are necessary in order to obtain Marketing Authorization for or to Develop, Manufacture or Commercialize a Drug Product or to use a facility for the Manufacture thereof, for or in a particular country or regulatory jurisdiction, including all rights under the foregoing, including rights to clinical data and Regulatory Exclusivity. Regulatory Materials include BLAs, INDs, ▇▇▇▇, presentations, responses, applications for Product Approvals and granted Product Approvals.
“Regulatory Warning Notices” means Form FDA 483 Inspectional Observations, Establishment Inspection Reports, warning letters, or their equivalents and any similar correspondences received from the FDA or any other Governmental Authority having jurisdiction over a Drug Product or any facility for the Manufacture of a Drug Product or component thereof.
“Representatives” means a Party’s (and its Affiliates’, and additionally, in the case of Passage Bio, its Strategic Partners’), directors, officers, full-time employees, part-time employees, temporary workers, subcontractors, consultants, agents, permitted sublicensees (if any) and legal, technical, and business advisors.
“Reprocess” or “Reprocessing” means introducing a Batch back into, and repeating appropriate manipulation steps that are part of, the established Manufacturing process.
“Scope of Work” means the work stages, schedules and budgets which are attached to this Agreement under Exhibit B relative to the Development Services, cGMP Manufacturing and Process Performance Qualification for the Passage Bio Products in the BWI Facility for the Manufacture of the Passage Bio Products.
“Specifications” shall mean any and all chemical, physical, microbiological and biological test methods and any specifications required for release by Catalent to Passage Bio of Passage Bio Products that have been predetermined and mutually approved by the Parties pursuant to an applicable Scope of Work.
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“Storage Guidelines” means those procedures (based on information provided by Passage Bio), as approved by Passage Bio in writing, methods and conditions for packaging (including, as applicable, use of digital artwork files or labels provided by Passage Bio), preserving, monitoring and storing all Passage Bio Materials, Raw Materials, Bulk Drug Substance and/or Drug Product, as set forth in the Quality Agreement or as otherwise mutually agreed to in writing by the Parties.
“Strategic Partners” means the individuals or entities that are part of a strategic partnership, which is a relationship between two commercial enterprises formalized by one or more business contracts.
“Technology” means all inventions, methods, techniques, trade secrets, copyrights, Know-How, knowledge, data, developments, discoveries, documentation, experience, formulas and formulations, proprietary information, processes, test procedures, hardware, software and other intellectual property of any kind, whether or not protectable under patent, trademark, copyright or similar Law.
“Territory” means the U.S. and [*] and any other country that the Parties agree in writing to add this definition of Territory in an amendment to this Agreement, but excluding any countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States. Catalent shall not be obliged to Process Products for sale in any of such countries if it is prevented from doing so, or would be required to obtain or apply for special permission to do so, due to any restriction (such as an embargo) imposed on it by any governmental authority, including those imposed by the U.S. Department of the Treasury’s Office of Foreign Assets Control.
“Third Party” means any Person other than the Parties.
“U.S” means the United States of America and its possessions and territories.
| 1.2 | Additional Definitions. The following terms have the meanings set forth in the corresponding Sections of this Agreement: |
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Defined Term | Section | |
AAV | Recitals | |
ACTUAL DAMAGES CAP | 20.2(g) | |
Actual Passage Bio Receipt | 8.2(b) | |
Additional Batches | 2.5.4(a), Exhibit C | |
Amendment Effective Date | Preamble | |
Approved Production Schedule | 2.5.5, Exhibit C | |
Arising IP Patents | 15.7 | |
Audit | 17.2(b) | |
Auditing Party | 11.9 | |
Batch Documentation | 9.2(d) | |
Batch Investigation | 7.1(c) | |
Batch Processing | 7.1(a) | |
Binding Quarter | 2.5.2, Exhibit C | |
BQ | 2.5.2, Exhibit C | |
BWI Facility | Recitals | |
Catalent | Preamble | |
Catalent Arising IP | 15.4 | |
Catalent Indemnitee | 18.7 | |
Catalent Project Manager | 9.1(b) | |
Catalent Records | 17.1(a) | |
cGMP Manufacturing Runs | 4.1(a) | |
CIP | 10.1 | |
CMC | 11.1 | |
Collaboration Agreement | Recitals | |
Confidential Information | 14.3 | |
Continuous Improvement Program | 10.1(h) | |
Defective Batch | 7.1(b) | |
Development Services | 4.1(a) | |
Disclosing Party | 14.3(a) | |
Disclosure Agreement | 14.1 | |
Divestee | 19.2(c) | |
Divestiture | 19.2(c) | |
Divestiture Event | 19.2(c) | |
Divestiture Event A | 19.2(c) | |
Divestiture Event B | 19.2(c) | |
Divestiture Event C | 19.2(c) | |
Divestiture Fee | 19.2(c) | |
Effective Date | Recitals | |
Failed Batch | Section 7.1(b) | |
Force Majeure Event | 13.1 | |
Forecast Modification | 2.5.4(a), Exhibit C | |
FQ | 2.5.1, Exhibit C | |
Indemnified Party | 18.8 | |
Indemnifying Party | 18.8 | |
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Letter Agreements | Recitals | |
Loss | 18.6 | |
NBQ | 2.5.2, Exhibit C | |
Original Collaboration Agreement | Recitals | |
Original DSCSA | Recitals | |
Parties | Preamble | |
Party | Preamble | |
Passage Bio | Preamble | |
Passage Bio Approval | 4.6(a) | |
Passage Bio Arising IP | 15.5 | |
Passage Bio Indemnitee | 18.6 | |
Payment Schedule | 4.7(a) | |
PPQ | 4.1(a) | |
PPQ Completion Date | 4.4 | |
Primary Cause | 7.1(c) | |
Prior Agreements | Recitals | |
Process Performance Qualification | 4.1(a) | |
Procurement Cost | 4.7(c) | |
Proposed Production Schedule | 2.5.5, Exhibit C | |
Quality Representative | 9.1(a) | |
Receiving Party | 14.3(a) | |
Repeat Supply Failure | 2.5.6, Exhibit C | |
Retained Copies | 20.2(i) | |
Rolling Forecast | 2.5.1, Exhibit C | |
Scope of Work | 4.1(a) | |
SP Credit | 2.6.1, Exhibit C | |
Supply Failure | 2.5.6, Exhibit C | |
Supply Pricing | 1.1, Exhibit C | |
Term | 20.1(a) | |
Terminating Event | 7.1(a) | |
Termination Date | 20.2(a) | |
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EXHIBIT B
SCOPE OF WORK
EXHIBIT C
BATCH ORDERING AND FORECASTING REQUIREMENTS
This Exhibit C establishes the Parties understanding as to the establishment of procedures for the forecasting (and rolling forecasts) of Passage Bio’s ordering of Batches of the Passage Bio Products.
ARTICLE I
SUMMARY
1.1Batch Pricing Based on Manufacturing Configuration. Each Passage Bio Product being Manufactured by Catalent pursuant to this Agreement may have differing Manufacturing Configurations. In addition, such Manufacturing Configurations may change during the Term for the same Passage Bio Product. Accordingly, pricing for clinical supply of Passage Bio Products will vary depending upon the Manufacturing Configuration utilized in the Manufacture of Batches of such products and shall be set forth in each Scope of Work (the “Supply Pricing”). For the purposes of this Agreement, the Supply Pricing for the Term is based upon a Manufacturing Configuration of [*] and is set forth in Schedule 1.1 of this Exhibit C. For all other clinical supply and any new commercial supply Manufacturing, the applicable Supply Pricing for Batches of Bulk Drug Substance and Drug Product of Passage Bio Products will be agreed to by the Parties and provided in each Scope of Work.
1.2No Minimum Annual Requirements. The Parties hereby acknowledge and agree that, notwithstanding anything to the contrary, Passage Bio has no minimum annual ordering requirements, minimum annual purchase requirements, or other minimum ordering or purchase obligations under this Agreement (including this Exhibit C).
ARTICLE II
CLINICAL MANUFACTURE AND COMMERCIAL SUPPLY
2.1[Reserved]
2.2[Reserved]
2.3[Reserved]
2.4Purchase Orders; Forecasts; Procedures.
2.4.1Upon receipt of a Purchase Order from Passage Bio pursuant to this Agreement, Catalent shall Manufacture Batches of Bulk Drug Substance and/or Drug Product at the BWI Facility in accordance with the Product Requirements, cGMPs, the then-current Quality Agreement and any Applicable Laws and otherwise in accordance with this Agreement.
2.4.2Purchase Orders shall include orders for Drug Product, however, the Manufacture of Batches of Drug Product shall be performed in accordance [*], which schedule shall generally consist of the Manufacture and Delivery of Batches of Drug Product [*] the Delivery of Batches of Bulk Drug Substance of each Passage Bio Product in a quantity [*] necessary for the Manufacture of one or more Batches of Drug Product.
2.5Rolling Forecasts; Delivery.
2.5.1Passage Bio shall continue to provide to Catalent a rolling forecast of its Batch requirements for the Delivery of Bulk Drug Substance for the following [*] fiscal quarters (each an “FQ” and consecutively commencing on [*] and [*] (the “Rolling Forecast”). The Rolling Forecasts shall provide the number of Batches of Bulk Drug Substance for the Passage Bio Products.
2.5.2Subject to the rights to make adjustments set forth herein, the Rolling Forecast shall be binding as to the [*] FQs (such quarters are each a “Binding Quarter” or “BQ” and the entire period is the “Binding Orders Period”) and non-binding as to the following [*] FQs (such quarters are each a “Non-Binding Quarter” or “NBQ”). Rolling Forecasts shall be provided by Passage Bio to Catalent in a form of notice substantially similar to the example notice provided in this Exhibit as Attachment A.
2.5.3
2.5.4Forecast Modification; Monitoring.
(a)Passage Bio will be afforded the flexibility to make modification requests to the Rolling Forecasts, as set forth below (each a “Forecast Modification”). Following the delivery of Rolling Forecasts, if a Forecast Modification is made for [*] that requests the Manufacture of one or more Batch( es) of Passage Bio Product( s) other than that which was originally forecasted, Catalent shall use commercially reasonable efforts, but shall not be obligated, to Manufacture the Batch(es) of different Passage Bio Product(s). If a Forecast Modification is made for [*] that requests additional Batches over what was originally forecast (the “Additional Batches”), Catalent shall use commercially reasonable efforts, but shall not be obligated, to Manufacture the Additional Batches.
(b)[Reserved]
(c)If the Forecast Modification reduces the number of Batches of Bulk Drug Substance of a Passage Bio Product that were to be Delivered by Catalent during the Binding Orders Period under Section 2.5.2 of this Exhibit C and Passage Bio is unable to substitute one or more Batches as provided for in subsection (a) above, Passage Bio shall be obligated to pay Catalent according to the table below for all such Batches ordered in that Binding Orders Period that were cancelled. Cancellation of any orders of Drug Product of a Passage Bio Product shall be subject to the same cancellation fees below; provided that no such cancellation fees shall apply for any such orders of Drug Product cancelled prior to the date that is [*] days prior to the Manufacturing Start Date for the cancelled Batch of Drug Product.
[*]
During the period in which Catalent is Manufacturing Bulk Drug Substance and/or Drug Product, the JSC will have periodic teleconferences or meetings to monitor and review the status of Manufacturing operations and to address any issues that may arise.
2.5.5Delivery Dates. Within [*] days following Catalent’s receipt of each Rolling Forecast, Catalent shall prepare, with input from Passage Bio, and submit to the JSC a Batch production schedule for the next Binding Orders Period which includes the order of production of each Batch of Passage Bio Product forecasted and the anticipated delivery of the Batch Documentation for each such Batch to Passage Bio (the “Proposed Production Schedule”). Within [*] days following receipt of the Proposed Production Schedule from Catalent, [*] (the “Approved Production Schedule”). For each Batch of Passage Bio Product being Manufactured during a Binding Orders Period, the Approved Production Schedule for that Batch shall be based upon [*]. Within [*] days upon [*] approval of the Approved Production Schedule, Passage Bio (and each Passage Bio Affiliate and/or Strategic Partner) shall submit to Catalent Purchase Orders specifying the number of Batches and the anticipated delivery dates ( as specified in the Approved Production Schedule). If for any reason Catalent is unable to Deliver the required Batches of Passage Bio Products specified in a Purchase Order on or before the anticipated Delivery date set forth in the Approved Production Schedule, Catalent shall notify Passage Bio promptly upon discovery of its inability to meet the Approved Production Schedule and, [*]. All Purchase Orders submitted in compliance with this Agreement shall be binding on Catalent. No later than [*] days after Passage Bio’s submission of a Purchase Order, Catalent shall provide Passage Bio with written acknowledgment of receipt of the Purchase Order. Catalent shall timely Manufacture and Deliver the amounts ordered by Passage Bio in accordance with this Section 2.5.5, and Catalent shall use commercially reasonably efforts to Manufacture and Deliver any Additional Batches; it being understood that Catalent’ s failure to supply such Additional Batches shall not constitute a breach under this Agreement.
2.5.6Supply Failure. During each Binding Orders Period, if Catalent fails to supply Batches of any Passage Bio Products that meet the Specifications in such numbers that equate to [*], a “Supply Failure” shall be deemed to have occurred upon receipt of written notice from Passage Bio. In the event Passage Bio, at its discretion, elects to delay the restart of a Failed Batch thereby pushing out the anticipated restart date, the additional time to push out the restart shall not count against [*]. Within [*] days of receipt of written notice from Passage Bio of its determination that a Supply Failure has occurred, Catalent shall complete an investigation and report to the JSC the cause of or reason for the Supply Failure and the appropriate corrective action to prevent such failure from reoccurring. The Parties shall review such plan, and if found reasonably acceptable, approve the plan on a timely basis such that Catalent is able to implement it prior to the next production run. Thereafter, as to the delayed or failed Batches of Passage Bio Product that attributed to the Supply Failure, Catalent shall [*]. If (i) [*], (ii) [*], or (iii) [*] (any of (i) through (iii) being a “Repeat Supply Failure”), Passage Bio shall have the right [*].
2.6Credits.
2.6.1SP Credits. In the event that a Passage Bio Strategic Partner purchases Bulk Drug Substance manufacturing services from Catalent, Catalent shall provide a credit to Passage Bio against any fees or payments owed by Passage Bio under this Agreement (including, without limitation, any Scope of Work hereunder) or any future agreements between Catalent, on the one hand, and Passage Bio, its Affiliates and/or its Strategic Partners, on the other hand, for the clinical supply Manufacturing of Passage Bio Products, in an amount equal to [*] of the total amount paid by such Strategic Partner for such manufacturing services, exclusive of any passthrough costs (such credit, the “SP Credit”).
EXHIBIT C, ATTACHMENT A
[Form of Passage Bio Notice of Batch Forecasts]
EXHIBIT C, SCHEDULE 1.1
Supply Pricing
[*]
EXECUTION VERSION
EXHIBIT D
Approved Subcontractors
[*]