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MASTER SUPPLY AGREEMENT This Master Supply Agreement (the " Agreement ") is effective as of

Key Takeaway: MASTER SUPPLY AGREEMENT This Master Supply Agreement (the "Agreement") is effective as of March 2, 2020 (the "Effective Date"), by and among: FibroGen, Inc., a Delaware corporation with offices located at 409 Illinois Street, San Francisco, CA 94158 U.S.A., and its Affiliates (c

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MASTER SUPPLY AGREEMENT
This Master Supply Agreement (the "Agreement") is effective as of March 2, 2020 (the "Effective Date"), by and among: FibroGen, Inc., a Delaware corporation with offices located at 409 Illinois Street, San Francisco, CA 94158 U.S.A., and its Affiliates (collectively, "FibroGen"); and Shanghai SynTheAll Pharmaceutical Co., Ltd (d/b/a " "), a company organized under the laws of the People's Republic of China, having a principal place of business at No. 9, Yuegong Road, Jinshan District, Shanghai Chemical Industry Park, Shanghai 201507, People's Republic of China ("Shanghai STA"); and STA Pharmaceutical Hong Kong Limited (d/b/a " "), a company organized under the laws of Hong Kong, having a principal place of business at 304 Dominion Center, 43 Queen's Road East, Wanchai, Hong Kong, People's Republic of China ("STA Hong Kong"). Shanghai STA and STA Hong Kong, and each of their Affiliates, shall collectively be referred to herein as "STA". FibroGen and STA may be referred to individually as a "Party", and collectively as the "Parties".
WHEREAS, FibroGen and STA are parties to that certain Manufacturing and Process Development Master Services Agreement, effective as of December 6, 2011 as amended by Amendment No. 1 on December 6, 2016 ("Development MSA");
WHEREAS, FibroGen owns or controls certain technology and intellectual property relating to the compound known as roxadustat (or FG-[ ]);
WHEREAS, STA has the expertise, resources, facilities and personnel to act as a contract manufacturing organization;
WHEREAS, FibroGen desires to engage STA to perform Manufacturing Services for FibroGen relating to roxadustat, including without limitation the manufacture and supply of bulk roxadustat (as active pharmaceutical ingredient) for FibroGen's (or other Recipients') use in the commercialization and development of products containing roxadustat, on the terms set forth below; and
NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties hereto agree as follows:
The following capitalized terms, whether used in the singular or plural, shall have the meanings ascribed to them below for purposes of this Agreement:
1.2"Affiliate" means, with respect to either Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, the term "control" means direct or indirect ownership of more than fifty percent (50%) of the outstanding voting securities or other ownership interests or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, or otherwise. Affiliates of FibroGen shall include, without limitation, any wholly foreign owned entities (whether owned or controlled directly by FibroGen or through one of its subsidiaries).
1.3"API" means the chemical compound or bulk active pharmaceutical compound, known as FG-[ ], whose specific INN name is [ ].
1.4 "Applicable Law(s)" means all laws, rules, and regulations applicable to the Manufacturing Services or otherwise bearing on the performance of this Agreement, and the relevant Forecasts or Stockpile Order, including, as applicable, cGMP and other regulatory standards or requirements of Regulatory Authorities.
1.5"Batch(es)" means a specific quantity of a certain Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture as specified in the applicable Forecasts and Stockpile Orders.
1.6"Batch Documentation Package" means all of the documentation associated with the production, manufacturing, packaging, labeling, testing, and release of a given Batch, including without limitation, Executed Batch Records, sampling documentation, raw data, test results, deviation reports, the Certificate of Analysis, the Certificate of Compliance, and any additional documentation required under the applicable Quality Agreement.
1.7"Binding Forecast" has the meaning set forth in Section 2.2.1 hereof.
1.8"BSE" means Bovine Spongiform Encephalopathy.
1.9 "Certificate of Analysis" means a document prepared by STA certifying that a particular Batch of Product was tested and conforms to the Specifications. Unless otherwise agreed to in a signed writing by both Parties, the Certificate of Analysis shall be in both the English and Chinese languages.
1.10"Certificate of Compliance" means a document prepared by STA that states that a particular Batch of Product was manufactured in compliance with the Quality Agreement and: (a) lists the manufacturing date, unique Batch number, Product number, and quantity of Product in such Batch; (b) certifies that such Batch was manufactured in accordance with the Master Batch Record and all Applicable Laws including cGMP; and (c) certifies all excursions and investigations associated with the Batch have been closed and found to not impact Batch. The Parties shall from time to time agree upon a format or formats for the Certificate of Compliance to be used under this Agreement. Unless otherwise agreed to in a signed writing by both Parties, the Certificate of Compliance shall be in both the English and Chinese languages.
1.11 "cGMP" means the current good manufacturing practices for the manufacture of pharmaceutical products, including without limitation: (a) the United States Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 321 et seq.) and the regulatory requirements for current good manufacturing practices as promulgated by the FDA thereunder; including without limitation 21 C.F.R. Part 11 (as applicable to electronic systems used in the manufacture of Product); and (b) the regulatory requirements for current good manufacturing practices as promulgated by the International Conference on Harmonization (ICH), Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; and (c) the European Community Directive 2003/94/EC of October 8, 2003; and (d) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products; and (e) the regulatory requirements for current good manufacturing practices as promulgated by the NMPA or other equivalent Regulatory Authority in the PRC; and (f) Good Quality Practices (GQP) for Marketing Authorization Holder under MHLW Ministerial Ordinance No.136 on Standards for Quality Assurance of Drugs, Quasi-drugs, Cosmetics and Medical Devices (established as of September 22, 2004); and (g) MHLW Ministerial Ordinance No. 179 on Standards for Manufacturing Control and Quality Control of Drugs and Quasi-drugs (revised as of December 24, 2004); and (h) all additional Regulatory Authority documents and regulations that replace, amend, modify, supplant or complement any of the foregoing and any amendments to the foregoing, including those specified in the Quality Agreement; and (i) any and all current Good Manufacturing Practices applicable to the manufacture, testing and/or any other processing of pharmaceutical products in other countries and territories worldwide where the respective Final Products are sold or otherwise marketed from time to time provided that STA is informed about such other Good Manufacturing Practices by FibroGen in accordance with Quality Agreement prior to the manufacture of such Products so as not to delay release of the Final Product.
1.12"Confidential Information" means FibroGen Confidential Information and/or STA Confidential Information, as the context requires.
1.13"Conforming" means, with respect to a Product, that such Product conforms to all of the requirements and acceptance criteria of this Agreement, including all Applicable Laws, the Specifications, Quality Agreement, and warranties set forth in Section 11.3, as applicable.
1.14"Control" or "Controlled" means possession of the right to grant a license or sublicense as provided for herein without violating (a) any law or governmental regulation applicable to such license or sublicense, or (b) the terms of any agreement or other arrangement with any Third Party that exists as of the Effective Date, or if such right is acquired after the Effective Date, as of the date the Party first gained possession of such right.
1.15"Delivery Date" means the date specified in a Binding Forecast for shipment by STA of Product.
1.16 "EMA" means the European Medicines Agency, or any successor agency thereto.
1.17"Executed Batch Records" means the collection of records that provides a traceable history of how a Batch of Product was produced.
1.18"Expiration Date" or "Expiry Date" means [ ]. (See also [ ].)
1.19 "FDA" means the United States Food and Drug Administration, or any successor agency thereto, having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products in the United States.
1.20 "FG-[ ]" means [ ].
1.21 "FG-[ ]" means [ ].
1.22 "FG-[ ]" means [ ].
1.23"FG-[ ]" means [ ].
1.24 "FibroGen Confidential Information" means any research, development, clinical, manufacturing, or commercialization strategies, and all related technical and other data and information, whether patented or unpatented, that relate to FibroGen Materials, FibroGen's compound structures, synthesis, formulation and manufacturing methods, test methods, operations, technologies, Forecasts and business and scientific plans, including without limitation, trade secrets, know-how, and other intellectual property, that is disclosed to, observed by or supplied to STA in any form by or on behalf of FibroGen pursuant to this Agreement, or data, results, and information included in or relating to the Products generated by STA in the course of performing Manufacturing Services pursuant to this Agreement. For clarity, all Product, Manufacturing Processes, Batch Documentation Package, Master Batch Records, FibroGen Intellectual Property, FibroGen Materials, FibroGen Owned Work Product, and Project Intellectual Property shall be deemed to be FibroGen Confidential Information.
1.25"FibroGen Intellectual Property" means all Intellectual Property owned or Controlled by FibroGen.
1.26"FibroGen Materials" means any materials (including progeny, derivatives, and modifications thereof) that are provided by or on behalf of FibroGen to STA for the purpose of performing Manufacturing Services. For clarity, [ ] or FG-[ ] may be supplied as a FibroGen Material.
1.27"FibroGen Owned Work Product" has the meaning set forth in Section 10.1.
1.28"Final Product" means a final product sold to the public that includes Product supplied hereunder.
1.29"Forecast" means a monthly forecast of FibroGen's anticipated requirements for Product to be manufactured by STA, as provided in Section 2.2.1.
1.30 "Intellectual Property" means all Patents, copyrights, trade secrets, know-how, inventions, and all other intellectual property rights that are owned or Controlled by a Party (whether patentable or not), including all applications and registrations with respect thereto.
1.31"IND" means Investigational New Drug Application (as more fully defined in 21 C.F.R. 312 et seq.) and all amendments and supplements thereto filed with the FDA, or the equivalent application filed with any other Regulatory Authority.
1.32"KPI(s)" has the meaning set forth in Section 2.8 hereof.
1.33"Latent Defects" has the definition set forth in Section 4.1.2
1.34 "Master Batch Record" or "MBR" means the document agreed on by the Parties in a signed writing that defines the Manufacturing Process of particular Product, and pertains to the manufacture and supply of each Batch of Product, as may be amended from time to time by a signed writing of the Parties. The Master Batch Record shall include, without limitation, the appropriate applicable requirements for components (such as Raw Materials, FibroGen Materials, intermediates, in-process materials, and packaging materials and labels) and quantities of each as used; major production equipment; detailed production instructions, including sequences to be followed; sampling instructions and in-process controls with their acceptance criteria; time limits for completion of individual processing steps and/or the total process; expected yield ranges at appropriate phases of processing or of time; special notations and precautions to be followed; and instructions for storage of the intermediate, in-process material, Product to assure its viability for use. The Master Batch Record shall be presented in both the English and Chinese languages, or as otherwise set forth in the Quality Agreement. The Master Batch Record shall also incorporate by reference, without limitation, such additional information as may be required under the Quality Agreement.
1.35"Manufacturing Improvements" has the meaning set forth in Section 10.2.
1.36"Manufacturing Process(es)" means production processes for the manufacture of Product.
1.37"Manufacturing Services" has the meaning set forth in Section 2.3.2.
1.38"MHLW" means Japan's Ministry of Health, Labor & Welfare, of which the PMDA is a part of.
1.39"Non-Conforming" means, with respect to Product, that such Product is not Conforming.
1.40"NDA" means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq.) and all amendments and supplements thereto filed with the FDA, or the equivalent application filed with any equivalent Regulatory Authority outside the United States of America (including any supra-national agency such as in the European Union), including all documents,
data, and other information concerning a pharmaceutical product which are necessary for gaining regulatory approval to market and sell such pharmaceutical product.
1.41"NMPA" means the National Medical Products Administration of the People's Republic of China, or any successor agency thereto.
1.42"Patents" means, with respect to an invention, any patent or patent application, and any patent issuing therefrom, together with any extensions, reissues, reexaminations, substitutions, renewals, divisions, continuations, continuations-in-part, and foreign equivalents thereof, and any patent or patent application claiming priority to any application in common with any such patent containing a disclosure substantially similar to that of any such patent, all to the extent the foregoing contain claims covering such invention.
1.43"PMDA" means Japan's Pharmaceuticals and Medical Devices Agency, or any successor agency thereto.
1.44"PRC" means the People's Republic of China.
1.45"Product" means any tangible material that may be ordered by FibroGen under a Forecast (or Stockpile Order) pursuant to this Agreement, which may include: (a) API, (b) FG-[ ], (c) FG-[ ], (d) FG-[ ], and (e) FG-[ ].
1.46 "Project Intellectual Property" means Intellectual Property generated, made, conceived, or reduced to practice in the course of performing Manufacturing Services under this Agreement, whether solely by STA or jointly by STA and FibroGen. For clarity, Project Intellectual Property shall not include STA Background Intellectual Property or Manufacturing Improvements.
1.47 "Product Technical Agreement" or "PTA" means a product technical agreement that may detail the Specifications, cGMP, formulations, Manufacturing Processes, Subcontractors, packaging, labeling and Shipping Requirements (as applicable) for Product. Each such PTA shall be proposed by FibroGen and mutually agreed upon by the Parties as set forth in the Quality Agreement prior to manufacture of such Product.
1.48"Quality Agreement" means the quality agreement agreed on by STA and FibroGen in a signed writing that relates to the manufacture of Product, as may be amended from time to time by a signed writing of the Parties, and as more fully set forth in Article 8. If the Parties desire to enter into one or more PTAs, then all references in this Agreement to "Quality Agreement" shall also include the relevant PTA(s), if applicable.
1.49"Quality Control Procedures" has the meaning set forth in Section 8.2.
1.50"Quality Matters" has the meaning set forth in Section 8.1.
1.51"Raw Material" means all ingredients, excipients, packaging materials, and reagents, including labels, solvents and other components other than FibroGen Materials that are required to perform the Manufacturing Services and/or manufacture the Product.
1.52"Release Period" has the meanings set forth in Sections 4.1.1.
1.53"Recall" means any action by FibroGen and/or other Recipients to recover title or possession or halt distribution, prescription or consumption of Final Product manufactured from Product sold or shipped to Third Parties by FibroGen or other Recipients (including, without limitation, the voluntary withdrawal of the Product from the market). The term "Recall" also applies to Final Products manufactured from Product, which would have been subject to recall or withdrawal if it had been sold or shipped.
1.54"Recipient" means a designee of FibroGen, as specified in writing by FibroGen to STA that has been granted the right to receive Product.
1.55"Registration" has the meaning set forth in Section 6.1.
1.56"Regulatory Authority(ies)" means the NMPA, FDA, EMA, MHRA, ANVISA, PMDA, and all other relevant health, drug, environmental, and safety agencies pertaining to the country in which Manufacturing Services are performed, as well as other applicable, national, multi-national, state, regional or local regulatory agency, department, bureau, body or other government entity involved in or responsible for regulation of the relevant subject (including manufacture or sale of Product), as the context requires in this Agreement.
1.57"Regulatory Filing" means any or all applications submitted to Regulatory Authorities for the purpose of registering the Product or the Manufacturing Process as required by statute or regulation, and any amendments or supplements thereto, and any other filings required by the Regulatory Authorities relating to the manufacture, testing, sale or distribution of Product.
1.58"Reprocess" and "Reprocessing" means introducing a Product back into the process and repeating appropriate manipulation steps that are part of the established Manufacturing Process. Continuation of a process step after an in-process control test showing the process to be incomplete is not considered Reprocessing.
1.59"Re-test Date" means [ ]. (See also [ ].)
1.60"Rework" and "Reworking" means subjecting Product to one or more processing steps acceptable to FibroGen that are different from the established Manufacturing Process.
1.61 "Stockpile" or "Stockpiled Product" means the quantities of Product that are held in inventory and managed by STA in order to reduce time requirements for delivery of ordered Product.
1.62 "Seizure" means any action by the FDA or other Regulatory Authority to detain Final Products manufactured from Product or prevent the distribution, prescription, consumption or release of such Final Products manufactured from Product.
1.63"Shipping Requirements" means STA's methods of packaging, monitoring and shipping Product, as approved in writing by FibroGen and provided to STA by FibroGen. Shipping Requirements shall include Shipping Instructions (as applicable).
1.64"Shipping Instructions" means shipping instructions provided by FibroGen to STA, including delivery location and recipients for each Product ordered. Shipping Instructions shall constitute a part of Shipping Requirements (as applicable).
1.65 "Specifications" means the commercial specifications agreed on by the Parties in a signed writing, including as applicable the characteristics, formulae, labeling, expiry date, storage requirements, as may be amended from time to time by a signed writing of the Parties with STA's consent not to be unreasonably withheld.
1.66 "Subcontractor" means any independent entity that STA contracts with FibroGen's prior written consent pursuant to Section 3.7 to perform any Manufacturing Services or meet any obligations that are required under the terms and conditions of this Agreement and applicable Binding Forecast or Stockpile Order.
1.67"STA Background Intellectual Property" means all Intellectual Property that is: (a) used in the course of performing Manufacturing Services under this Agreement; and (b) owned or Controlled by STA prior to the Effective Date of this Agreement For clarity, STA Background Intellectual Property shall not include any FibroGen Intellectual Property, FibroGen Owned Work Product, Product, or any other Intellectual Property associated with FibroGen Materials. All STA Background Intellectual Property shall be solely owned by STA and deemed STA Confidential Information.
1.68"STA Confidential Information" means all confidential and proprietary information actually disclosed by STA to FibroGen in the course of performing Manufacturing Services under this Agreement and approved Forecast or Stockpile Order. For clarity, STA Confidential Information shall not include any FibroGen Confidential Information, Product, or FibroGen Owned Work Product.
1.69"STA Facility" means the facility listed in Section 3.1 hereto, which facility is owned and operated by STA and will be used for the performance of Manufacturing Services and the production of Products.
1.70 "Storage Fees" has the meaning set forth in Section 4.6 hereto.
1.71"Third Party" means any entity other than FibroGen, STA Hong Kong, Shanghai STA, their respective Affiliates and FibroGen's Recipients.
1.72"TSE" means Transmissible Spongiform Encephalopathy.
1.73"Waste" means any "hazardous substance" and/or "hazardous material" and/or any other waste material, pollutant and/or contaminant of any kind as defined by the Regulatory Authority(ies) having jurisdiction at the STA Facility, including, without limitation, any Raw Materials, in-process materials, routine process waste or any by-product arising from any activities conducted pursuant to this Agreement.
FORECASTS AND SUPPLY; STOCKPILE ORDERS
2.1Master Agreement.
2.1.1This Agreement establishes the general terms and conditions applicable to STA's manufacturing and supply of Products to FibroGen. This Agreement is intended to allow the Parties to contract for the performance of manufacturing and supply of one or more Products through the execution of separate written orders or Forecasts in accordance with and consistent with this Agreement. Each Binding Forecast or Stockpile Order shall become part of and incorporated by reference into this Agreement as a separate written order and each Binding Forecast or Stockpile Order shall be subject to all of the terms and conditions of this Agreement. Any changes to a Binding Forecast or Stockpile Order shall be agreed to in a signed writing by the Parties prior to any such changes being effective.
2.2.1To facilitate STA's production capacity planning, within [ ] ([ ]) [ ] days of execution of this Agreement, and prior to [ ] during the Term of this Agreement, FibroGen shall provide to STA a [ ] forecast (each a "Forecast") of the quantities of each Product FibroGen requires STA to deliver. By way of example, the Forecast delivered in [ ] will cover the period from [ ] to [ ]. The first [ ] of each Forecast shall be binding [ ] ("Binding Forecast"), and the following [ ] shall be non-binding. [ ].
2.2.2[ ]. For example, if FibroGen requests an additional quantity or an earlier Delivery Date than previously set forth in a Binding Forecast, then STA shall use reasonable best efforts to fulfill such request, including using any of the STA Stockpile if STA chooses to, but shall not be required to.
2.2.3Forecasts shall include or specify (a) the Delivery Date and other relevant timeframes; (b) the description and quantity of Product ordered in metric tons [] to be manufactured and supplied by STA limited by all relevant previous Binding Forecasts; (c) the FibroGen Materials being provided by or on behalf of FibroGen (if any) for Product ordered or in the case Fibrogen and STA decide to [], whether STA should [__]; (d) any invoicing instructions in accordance with ARTICLE 5 hereof; and (e) if FibroGen requires STA to produce Product without FibroGen supplying [ ]. Each Binding Forecast complying with the requirements of this Section 2.2.3 shall be valid and binding upon the submission of such Binding Forecast by FibroGen. Each such Binding Forecast submitted by FibroGen shall be governed by the terms and conditions of this Agreement (including the pricing set forth in Exhibit B hereto).
In the event that the terms of any Binding Forecast are not consistent with this Agreement, any such inconsistency or deviation must be agreed to in a signed writing by the Parties.
2.3Supply. Subject to the terms and conditions of this Agreement, STA hereby agrees to manufacture the Products (in quantities and by the Delivery Dates) according to the Forecasts submitted in accordance with Section 2.2.
2.3.1In order for STA to meet its supply obligations hereunder, FibroGen must [ ]
2.3.2Such manufacture and supply of Product and such provision of other
deliverables, such as the Batch Document Package (collectively, the "Manufacturing Services") shall be performed in a professional manner consistent with industry standards and in compliance with the terms and conditions of this Agreement, the Quality Agreement, the Specifications, and all Applicable Laws. STA covenants and agrees that it shall manufacture and supply Product solely for sale to FibroGen (including FibroGen's Affiliates and/or other Recipient as designated in writing by FibroGen) pursuant to this Agreement; and shall not otherwise manufacture, sell or transfer [] except as explicitly permitted by FibroGen under this Agreement. It is understood and agreed that FibroGen may engage other entities to manufacture Product in addition to STA, and nothing in this Agreement shall be construed to prevent FibroGen from doing so.
2.3.3STA agrees to deliver Product to FibroGen or other Recipients on a first in, first out basis, unless otherwise specified by FibroGen.
2.3.4Reporting. STA agrees to provide FibroGen with a monthly update as to the status and quantities of
(a)all Products being produced;
(b)all FibroGen Stockpiled Products being used and/or produced; and
(c)any additional FibroGen Stockpile STA needs to reasonably fulfill its supply obligations hereunder.
2.4FibroGen Stockpile. Through submission of work orders under the Development MSA, FibroGen has already purchased certain quantities of Product (as defined in Sect. 1.45) as FibroGen Stockpile as described in Exhibit D. [ ]. [ ]. FibroGen may issue one or more additional stockpile purchase orders (a "Stockpile Order") to STA to manufacture Products at the prices set forth on Exhibit C (the "FibroGen Stockpile"). STA shall manufacture such FibroGen Stockpile pursuant to any Stockpile Orders such that it can be available to meet the applicable Binding Forecasts. [ ].
2.4.1Once those Products are Stockpiled, STA may use (and then promptly replenish) such FibroGen Stockpile to fulfill its supply obligations under Section 2.3 in exchange for the full price of Product manufactured pursuant to the Binding Forecast. STA shall work diligently to replace and replenish the Stockpiled Product used pursuant to a Binding Forecast within the agreed upon timelines of: [ ].
2.5STA Stockpile. In addition to the FibroGen Stockpile set forth in Section 2.4, STA shall create and maintain a Stockpile of API [ ] of the Product forecasted by FibroGen to be delivered in the [ ] months (the "STA Stockpile"). If STA uses any of such STA Stockpile to fulfill amounts Forecasted or requested by FibroGen, STA shall work diligently to replenish the STA Stockpiled Product manufactured pursuant to a Binding Forecast, within [ ], provided that [ ].
Last updated: Mar 24, 2020