Manufacturing and Supply Agreement
Manufacturing and Supply Agreement
Exhibit 10.34
[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Manufacturing and Supply Agreement
Manufacturing and Supply Agreement
MANUFACTURING AND SUPPLY AGREEMENT
THIS MANUFACTURING AND SUPPLY AGREEMENT (the “Agreement”) is made as of the date of last signature (the “Effective Date”)
BY AND BETWEEN:
CHEMOCENTRYX, INC.
000 Xxxxx Xxxxxx, Xxxxxxxx Xxxx, XX 00000
a corporation existing under the laws of the State of Delaware
- and -
Vifor Fresenius Medical Care Renal Pharma Ltd.
Xxxxxxxxxxxxx 00, 0000 Xx. Xxxxxx Xxxxxxxxxxx
(“VF”)
WHEREAS CCX is a pharmaceutical company that is commercialising the Product (as defined in the License Agreement) and has licensed VF to conduct studies and commercialize the Product in certain countries pursuant to that certain Collaboration and License Agreement between CCX and VF’s affiliate, Vifor (International) Ltd., dated May 9, 2016 (as amended from time to time, the “License Agreement”). The License Agreement was assigned by Vifor (International) Ltd. to VF on December 30, 2016.
WHEREAS, pursuant to the License Agreement, the Parties agreed to enter into this Agreement to ensure supply of Bulk Drug Product (as defined in this Agreement) for commercialization of the Product in accordance with the License Agreement.
THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each Party), and intending to be legally bound the Parties agree as follows:
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Manufacturing and Supply Agreement
ARTICLE 1
STRUCTURE OF AGREEMENT AND INTERPRETATION
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1.1 |
Definitions. |
The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these terms will have corresponding meanings:
“Active Pharmaceutical Ingredients” or “API” has the meaning ascribed to it in the License Agreement.
“Affiliate” has the meaning ascribed to it in the License Agreement.
“Annual Forecast” has the meaning specified in Section 5.1(b).
“Annual Product Review Report” means the annual product review report prepared by CCX or an Affiliate of CCX as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e) and respective EU laws, directives and regulations;
“Applicable Laws” has the meaning ascribed to it in the License Agreement.
“Batch” means a defined quantity of Bulk Drug Product, Manufactured in one process or series of processes, so that it is expected to be homogeneous, in the quantity set out in the Specifications.
“Breach Notice” has the meaning specified in Section 8.2(a).
“Bulk Drug Product” has the meaning ascribed to it in the License Agreement.
“Business Day” has the meaning ascribed to it in the License Agreement.
“cGMPs” means, as applicable, current good manufacturing practices as described in:
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(a) |
Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations; |
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(b) |
EudraLex - Volume 4 Good Manufacturing Practices Guidelines published by the European Commission relating to Directive 2017/1572 (art. 2); and |
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(c) |
Division 2 of Part C of the Food and Drug Regulations (Canada); |
“Components” means, collectively, all packaging components, starting materials, excipients, ingredients, and other materials required to manufacture the Bulk Drug Products in accordance with the Specifications, other than the Active Pharmaceutical Ingredients.
“Confidential Information” has the meaning ascribed to it in the License Agreement.
“Continuous Improvements” has the meaning specified in Section 2.2.
“Contract Manufacturing Organization” or “CMO” means CCX’s Third Party manufacturer of the API, Component or Drug Product.
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Manufacturing and Supply Agreement
“Costs of Goods” has the meaning ascribed to it in the License Agreement.
“Deficiency Notice” has the meaning specified in Section 6.1(a).
“Delivery Date” means the date scheduled for shipment of Bulk Drug Product under a Firm Order as set forth in Section 5.1(d).
“EMA” means the European Medicines Agency.
“FDA” means the United States Food and Drug Administration.
“Firm Orders” has the meaning specified in Section 5.1(c).
“Governmental Authority” has the meaning ascribed to it in the License Agreement.
“Initial Forecast” has the meaning specified in Section 5.1(b).
“Intellectual Property” includes, without limitation, rights in Patents, Patent applications, formulae, Trademarks, Trademark applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, and Know-how.
“Inventions” means all inventions whether or not patentable, discovered, made, conceived, or conceived and reduced to practice, in the course of activities contemplated by this Agreement.
“Know-how” has the meaning ascribed to it in the License Agreement.
“Late Delivery” has the meaning specified in Section 5.4.
“Long Term Forecast” has the meaning specified in Section 5.1(a).
“MAD” has the meaning specified in Section 6.1(a).
“Manufacture” or “Manufacturing” means, all operations in the scheduling, production, packaging, labeling, warehousing, quality control testing (including as requested all in-process, release and stability testing), release and shipping of the Components, API and Bulk Drug Product performed by CCX qualified CMOs at their Manufacturing Sites in accordance with the Specifications and under the terms of this Agreement and the Quality Agreement for the Components, API and Bulk Drug Product hereunder.
“Manufacturing Services” means all Manufacturing to be carried out by or on behalf of CCX and/or its CMOs.
“Manufacturing Site” means the facility owned and operated by CCX’s CMOs as agreed with VF where the Manufacturing Services will be performed by such CMOs.
“MBR” has the meaning specified in Section 6.1(a).
“Minimum Order Quantity” means the minimum Batch size of a Bulk Drug Product to be produced as set forth on Schedule C.
“Party” means CCX or VF, individually, or collectively as the “Parties”.
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Manufacturing and Supply Agreement
“Patents” has the meaning ascribed to it in the License Agreement.
“Product Claims” has the meaning specified in Section 6.3(c).
“Quality Agreement” means the agreement between the Parties that sets out the quality assurance standards for the Manufacturing Services to be performed by CCX or its subcontractors for VF.
“Rampdown Period” has the meaning specified in Section 8.3(a) (iii).
“Recall” has the meaning specified in Section 6.2(a).
“Regulatory Approval” has the meaning ascribed to it in the License Agreement.
“Regulatory Authority” has the meaning ascribed to it in the License Agreement.
“Representatives” means a Party’s directors, officers, employees, advisers, agents, consultants, subcontractors, service partners, professional advisors, or representatives.
“Specifications” means the specifications for Bulk Drug Product supplied under this Agreement along with the set of analytical tests, methods and acceptance criteria applicable (schedule A) thereto, as such specifications may be amended and revised from time to time upon mutual agreement of the Parties in accordance with the terms of this Agreement to obtain or maintain approval of the Finished Product from any Regulatory Authority, including, without any limitation:
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(a) |
Manufacturing specifications, directions, instructions and packaging processes for the API, Components and Bulk Drug Product; |
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(c) |
All environmental, health and safety information for the API, Components and Bulk Drug Product, including material safety data sheets; |
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(d) |
The drug product composition packaging specifications and shipping requirements for the Bulk Drug Product; and |
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(e) |
The Specifications will include regulatory compliance obligations, as provided in this Agreement and in the Quality Agreement. |
“Supply Failure” means any situation where CCX is unable to supply at least seventy-five (75%) of a Firm Order for a period of three (3) months from the applicable Delivery Date.
“Territory” has the meaning ascribed to it in the term “VIT Territory” in the License Agreement.
“Third Party” means any entity other than CCX or VF or any Affiliate of CCX or VF.
“Third Party Rights” means the Intellectual Property of any Third Party.
“Trademarks” has the meaning ascribed to it in the License Agreement.
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Manufacturing and Supply Agreement
“Transfer Price” means the transfer price for Bulk Drug Product as set forth in Section 7.3 of the License Agreement. For clarity, Transfer Price shall, without limitation, include or exclude the items as expressly identified in Schedule B.
“Year” means in the first year of this Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter will mean a calendar year.
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1.2 |
Currency. |
All monetary amounts expressed in this Agreement are in United States Dollars (USD).
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1.3 |
Sections and Headings. |
The division of this Agreement into Articles, Sections, Subsections, an Appendix, Schedules and Exhibits and the insertion of headings are for convenience of reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section, Appendix, Schedule or Exhibit refers to the specified Section, Appendix, Schedule or Exhibit to this Agreement. In this Agreement, the terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement as a whole and not to any particular part, Section, Appendix, Schedule or Exhibit of this Agreement.
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1.4 |
Singular Terms. |
Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa.
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1.5 |
Schedules and Exhibits. |
The Schedules hereto and the following Exhibits are attached to, incorporated in, and form part of this Agreement:
Schedule A-API, Components and Bulk Drug Product Specifications
Schedule C- Minimum Order Quantity
Schedule D- List of approved CMOs
Schedule E-Technical Dispute Resolutions
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Manufacturing and Supply Agreement
ARTICLE 2
CCX MANUFACTURING services
The Parties agree to enter into this Agreement to ensure supply of Bulk Drug Product for commercialization of the Product (as defined in the License Agreement). Manufacturing and Supply of Bulk Drug Product for other purposes such us clinical trials, MAP programs or any other use beyond commercialization shall be agreed by the Parties on case by case basis and will be formalized in a separate agreement.
More in particular, if the JMC desires to qualify an additional source for the API, Component or Bulk Product, the Parties shall comply with the provisions of Section 7.1 of the License Agreement and CCX will provide VF with advance notice of any such change and the Parties shall cooperate to address any Regulatory Authority notices or Regulatory Approvals that may be required. CCX will not use such additional source before it is approved by both Parties as set forth in the paragraph above. CCX will promptly advise VF if it or any of its CMOs encounter supply problems, including delays and/or delivery of non-conforming API or Components.
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Manufacturing and Supply Agreement
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(f) |
Stability Testing. CCX will conduct stability testing on the API and Bulk Drug Products in accordance with the protocols set out in the Specifications. CCX will not make any changes to these testing protocols without prior written approval from VF. If a confirmed stability test failure occurs, CCX will notify VF within [***] Business Days, after which CCX and VF will have [***] Business Days to review the documents. CCX will provide VF with an opportunity to review and comment on CCX’s proposed response to its CMOs with respect to a confirmed stability test failure, which CCX shall reasonably consider. CCX and VF will jointly agree on the measures to be undertaken to investigate the cause of the failure, including which Party will bear the cost of the investigation. CCX will not be liable for these costs unless it has failed to perform the Manufacturing and/or the stability testing in accordance with the Specifications and cGMPs. CCX will give VF all stability test data and results promptly upon VF’s request. Notwithstanding anything to the contrary, taking any regulatory actions into account, CCX shall [***] with respect to the proceedings and methods to be to be undertaken in such investigations, and shall communicate with its CMOs regarding such matters. CCX shall provide to VF a copy of any related correspondence from its CMOs within [***] Business Days after CCX’s receipt thereof. |
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Manufacturing and Supply Agreement
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2.2 |
Continuous Improvement. |
CCX will use commercially reasonable efforts to ensure continuous improvements of the processing performance for the Bulk Drug Product at the Manufacturing Site in order to ensure efficient production, thereby generating potential savings that could be shared equally with VF through a reduction in the Transfer Price (“Continuous Improvements”). VF may assist CCX in its activities to generate and develop efficiency improvement and cost reduction ideas, new concepts and measures for implementation at the Manufacturing Site. This assistance may include audits, evaluation of joint engineering practices, new technologies and/or new manufacturing and supply chain management methods. CCX will use commercially reasonable efforts to make available sufficient resources to generate, develop and implement the Continuous Improvements. VF will reimburse CCX the reasonable costs incurred by CCX in carrying out the requested activities if the activities were pre-approved by VF in writing. The Joint Manufacturing Sub-committee (“JMC”) as regulated in the License Agreement will regularly meet and discuss continuous improvement matters. The Parties agree that any of VF’s sub-licensees may participate in the JMC. The Parties will conduct an annual JCM meeting where (i) CCX will inform VF about its annual continuous improvement and best practices goals and strategies in terms of potential savings and any potential reduction in the Transfer Price, and (ii) The Parties will agree on the allocation of costs required in implementing any Continuous Improvement efforts.
VF will pay CCX for performing the Manufacturing Services according to Article 4.
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Manufacturing and Supply Agreement
For purposes of illustration only, a sample calculation of Transfer Price for the Year 2024 follows:
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All payments to be made under this Agreement shall be made in U.S. dollars by wire transfer of immediately available funds to such U.S. bank account as shall be designated by a Party. Late payments shall bear interest at the rate provided in Section 4.7.
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Manufacturing and Supply Agreement
In the event that a Party disputes any amounts payable under this Agreement, such dispute shall be resolved (a) in accordance with Article 6 with respect to non-conforming Product and (b) in accordance with Article 12 with respect to any other dispute. Pending resolution of such disputes, a Party shall pay any amounts (whether under an invoice or otherwise) that are not in dispute. Upon resolution of any such dispute in favor of a Party, the other Party shall pay all remaining amounts owing under this Agreement within [***] Business Days after such resolution.
CCX shall keep, and, subject to the terms of the applicable agreement between CCX and a CMO, shall cause each of its CMOs to keep, full, true, and accurate books of accounting containing all particulars that may be necessary for the purpose of calculating the payments payable to CCX in accordance with GAAP or IFRS, as applicable, under this Article 4, for a period of [***] years after the calendar year in which the Bulk Drug Product was delivered, in sufficient detail to permit VF to confirm the accuracy of any payments paid hereunder.
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Manufacturing and Supply Agreement
During the term of this Agreement and for a period of [***] years thereafter, at the request and expense of VF, subject to the terms of the applicable agreement between CCX and a CMO, CCX shall permit an independent, certified public accountant of nationally recognized standing appointed by VF, and reasonably acceptable to CCX, during normal business hours and upon not less than [***] Business Days prior notice and in compliance with the audit limitations of any CMO agreement, but in no case more than [***] per calendar year, to examine such records of CCX as may be necessary for the sole purpose of verifying the calculation and reporting of the payments payable under this Agreement for any period within the preceding [***] calendar years. Results of any such examination shall be made available to both VF and CCX. Such accountant shall disclose to VF only the amounts which the accountant believes to be due and payable hereunder to VF or due and payable to CCX, and any information reasonably necessary for VF to evaluate any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. Any and all records examined by such accountant shall be deemed CCX’s Confidential Information, which may not be disclosed by such accountant to any Third Party. If, as a result of any inspection of the books and records of CCX, it is shown that payments made by VF under this Agreement were more than the amount that should have been made, then CCX shall promptly refund any amount required to eliminate any discrepancy revealed by said inspection, such refund to occur in any event within [***] days after notice thereof. If, as a result of any inspection of the books and records of CCX, it is shown that payments made by VF under this Agreement were less than the amount that should have been made, then VF shall promptly pay to CCX the difference between the amount actually paid and the amount that should have been paid within [***] days after the conclusion of such inspection. VF shall pay for such audits, except that in the event that CCX overcharged such payments by more than [***] during the period in question as per the audit, CCX shall pay the reasonable costs of the audit.
Without limiting any other rights or remedies available to CCX, VF shall pay CCX interest on any payments that are not paid on the date such payments are due under this Agreement at a rate equal to the lesser of (a) the [***] or (b) the highest rate permitted under the Applicable Law.
ARTICLE 5
ORDERS, SHIPMENT, INVOICING, PAYMENT
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5.1 |
Orders and Forecasts. |
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Manufacturing and Supply Agreement
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VF once every month on a rolling forward basis. These forecasts should be reasonably consistent with the Long Term Forecast. The Rolling Forecast for the first [***] months following the date of forecast shall be firm and binding on VF and CCX (the “Binding Period”) and will be covered by Firm Orders. The quantities projected in the Rolling Forecast for the following [***] months are non-binding, good faith estimates; provided that the forecast for the seventh through ninth month (the “Semi Flexible Period”) may only be modified within the range of [***] from month to month during the Semi Flexible Period. |
The Rolling 18 Month Forecast will be binding on both parties, as follows:
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(i) |
the Bulk Drug Product volumes ordered by Firm Orders during the first [***] months of the then-current Rolling Forecast may only be changed by written agreement between the Parties; and |
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(ii) |
the Semi Flexible Period of the then-current Rolling Forecast may only be modified within the range of [***] from month to month. |
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(c) |
Firm Orders. |
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(iii) |
If and when VF applies for a tender of Product to a Governmental Authority or if VF prepares for a launch of Product in a country, or if VF requires Product prior to a launch date due to e.g., regulatory requirements as part of a submission, VF shall notify CCXI in writing and provide to CCXI information relating to the anticipated volumes to be supplied under such tender or launch and the timing for deliveries thereunder. In such events, the Parties will discuss in good faith reasonable mechanisms for CCXI to provide supply of Product for such tender or launch The Parties agree that lead times for such orders related to a tender and/or a launch may have shorter lead times than regular orders. |
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Manufacturing and Supply Agreement
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(e) |
API Safety Stock for Bulk Drug Product manufacturing. [***], CCX agrees to use commercially reasonable efforts to hold enough safety stock of API to be able to manufacture at least the amount of Bulk Drug Product for the projected upcoming [***] months. This means in detail that CCX will hold or will make CMO hold enough API to ensure that CMO is able to manufacture Bulk Drug Product in the amount forecasted with the current Rolling Forecast at all times. |
VF may order Manufacturing Services for whole Batches of Bulk Drug Products only in multiples of the Minimum Order Quantities as set out in Schedule C.
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Manufacturing and Supply Agreement
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(d) |
Vifor shall accept delivery of Bulk Drug Product provided that the relevant quantity is within [***] of the quantity confirmed in the Firm Order. In case of shortfall, CCX will carry over the shortfall and supply this latter together with the next Firm Order. In case of a supply exceeding [***] of the quantity confirmed in the Firm Order, the Parties will discuss in good faith how to manage the over-delivery. |
If CCX is unable to deliver the Bulk Drug Product to VF in accordance with the terms of a Firm Order due to an act or omission by CCX or any of its agents, subcontractors or suppliers (a “Late Delivery”), CCX will, solely to the extent liquidated damages are actually received by CCX from its CMO for Bulk Drug Product, pay to VF its share of such liquidated damages received from such CMO. As of the Effective Date, CCX’s CMO for Bulk Drug Product is Patheon Pharmaceuticals Inc., and the liquidated damages are as follows:
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If Bulk Drug Product delivery occurs [***] days after the applicable Delivery Date, CCX reimburses to VF [***]% of the cost to VF of the applicable Firm Order; |
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If Bulk Drug Product delivery occurs [***] days after the applicable Delivery Date, CCX reimburses to VF [***]% of the cost to VF of the applicable Firm Order; |
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If Bulk Drug Product delivery occurs [***] days after the applicable Delivery Date, CCX reimburses to VF [***]% of the cost to VF of the applicable Firm Order; |
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If Bulk Drug Product delivery occurs [***] days after the applicable Delivery Date, CCX reimburses to VF [***]% of the cost to VF of the applicable Firm Order; or |
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If Bulk Drug Product delivery occurs [***] or more days after the applicable Delivery Date, CCX reimburses to VF [***]% of the cost to VF of the applicable Firm Order; |
A Late Delivery will not include any delay in shipment of Bulk Drug Product while CCX is exercising a right of excused performance in accordance with the requirements of Section 13.5.
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(a) |
Supply Failure. If a Supply Failure occurs, the Parties agree to, in accordance with Section 7.1 (Manufacturing Committee) of the License Agreement, [***]. If a second Supply Failure occurs within any [***] year period during the term of this Agreement, (i) such second Supply Failure (and only such supply failure) [***], and (ii) VF shall have the right to have CCX undertake technology transfer of the Manufacturing Services for the Product to a Third Party [***]. Such technology transfer costs will be at CCX’s expense and will be executed in a timely manner and in accordance with industry standards. The rights and obligations under this Section 5.5 (a) shall be subject to the terms and conditions of any applicable CMO agreement(s). |
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(b) |
Backup CMOs. Upon written request by VF, the Parties shall mutually agree upon and select backup CMO(s) in accordance with the terms of Section 7.1 (Manufacturing Committee) of the License Agreement. Upon mutual selection of any backup CMO, CCX shall engage such backup CMO(s) and perform technology transfer to qualify such backup CMO(s) as soon as reasonably practicable. The Parties shall share equally in the costs of such technology transfer to backup CMOs. For clarity, except as set forth above, [***]. |
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Manufacturing and Supply Agreement
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ARTICLE 6
PRODUCT CLAIMS AND RECALLS
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(c) |
Shortages and Price Disputes. Claims for shortages in the amount of Bulk Drug Product shipped by CCX or a Transfer Price dispute will be dealt with by reasonable agreement of the Parties. |
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Manufacturing and Supply Agreement
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(c) |
Product Returns. VF will have the responsibility for handling customer returns of the Product. CCX will give VF any assistance that VF may reasonably require to handle the returns. |
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(d) |
Recall Expenses. All expenses related to a Product Recall shall be borne by the Party responsible for the defect(s) or issue(s) that resulted in such Recall. To the extent both Parties bear responsibility for such Recall, then each Party shall pay its pro-rata portion of such Product Recall expenses. In the event of a dispute regarding allocation of responsibility between the Parties under this Section 6.2(d), the Parties shall submit such dispute for resolution in a manner consistent with Section 6.1(b) (Determination of Deficiency). |
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(b) |
Recalled Product. If a Recall or return results from, or arises out of, a failure by CCX to perform the Manufacturing Services in accordance with the agreed Specifications, cGMPs, or Applicable Laws, CCX will be responsible for the [***]. |
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(d) |
Notwithstanding anything to the contrary in this Agreement, CCX will only be required to [***] to the extent [***] in accordance with the terms of this Agreement. |
VF will not dispose of any damaged, defective, returned, or recalled Bulk Drug Products or Products for which it intends to assert a claim against CCX without CCX’s prior written authorization to do so. Alternatively, CCX may instruct VF within [***] days after determination of the Bulk Drug Products or Products being defective to return the Bulk Drug Products or Products to CCX. CCX will [***]. In all other circumstances, [***].
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Manufacturing and Supply Agreement
VF will have the sole responsibility for responding to questions and complaints from its customers. Any such questions or complaints received by CCX from VF’s customers, healthcare providers or patients will be promptly referred to VF. Relevant complaints received at VF from VF’s customers will be transmitted to CCX for its assessment / investigation. CCX will investigate the received complaints and send an investigation report within [***] days to VF (for further information of VF’s customers). CCX will co-operate as reasonably required to allow VF to determine the cause of and resolve any questions and complaints. This assistance will include follow-up investigations, including e.g. testing. In addition, CCX will give VF all agreed upon information that will enable VF to respond properly to questions or complaints about Product as set forth in the Quality Agreement. Unless it is determined that the cause of the complaint resulted from a failure by CCX to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, all reasonable and demonstrated costs incurred under this Section 6.5 will be borne by VF.
Except for the indemnity set forth in Section10.3 and subject to any applicable limitations set forth in Sections 10.1 and 10.2, the remedies described in this Article 6 will be VF’s sole remedy in contract, tort, equity or otherwise for any failure by CCX to provide the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. This Section 6.6 does not affect the availability of any other remedy that VF may have for CCX’s breach of any of its other obligations under this Agreement.
The detailed process for deviations and change control between CCX and VF is defined in the Quality Agreement. Major or critical deviations must be [***] prior to batch release at CCX.
ARTICLe 7
CO-OPERATION
Each Party may, subject any applicable terms in the Quality Agreement, communicate with any Governmental Authority, including but not limited to Governmental Authority responsible for granting Regulatory Approval for the Bulk Drug Products, regarding the Bulk Drug Products if, in the opinion of that Party’s counsel, the communication is necessary to comply with the terms of this Agreement and Section 5 of the License Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a Party will permit the other Party to receive copies of all communications from the Governmental Authority pertaining to Manufacturing of the Product.
Except as otherwise provided in the Quality Agreement, CCX will keep records of the manufacture, testing, and shipping of the API, Components and Bulk Drug Products, and reference and retention of samples of the API, Components and Bulk Drug Products as are necessary to comply with manufacturing regulatory requirements applicable to CCX, as well as to assist with resolving API, Components and Bulk Drug Product complaints and other similar investigations. Unless otherwise agreed to in the Quality Agreement, copies of the records and samples will be retained for [***] year following the date of API, Components or Bulk Drug Product expiry, or longer if required by law or regulation, following which time VF will be contacted concerning the delivery or destruction of the documents and/or samples of API, Components and Bulk Drug Products. CCX reserves the right to destroy or return to VF, at VF’s sole expense, any document or samples for which the retention period has expired if VF fails to arrange for destruction or return within [***] days of receipt of notice from CCX. CCX is responsible for retention of samples of the API, Components and Bulk Drug Products necessary to comply with the legal/regulatory requirements applicable to VF.
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Manufacturing and Supply Agreement
VF may inspect CCX’s or its CMO’s (subject to the terms and conditions of CCX’s CMO agreements) processes, facilities and premises, including reports and records relating to this Agreement during normal business hours and with reasonable advance notice, but a CCX representative shall have the right to be present during the inspection. CCX shall procure the inspection by VF of its CMO’s (subject to the terms and conditions of CCX’s CMO agreements).
Subject to the terms and conditions of CCX’s CMO agreements, CCX will arrange to give VF, together with CCX, reasonable access at agreed times to the areas of the Manufacturing Site in which the API, Components, Bulk Drug Product and Products are manufactured, stored, handled, or shipped to permit VF to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws. But, with the exception of “for-cause” audits, VF will be limited to [***] cGMP-type audit every [***] per each CMO [***], [***]. The right of access set forth in Sections 7.3 and 7.4 will not include a right to access or audit CCX’s or its CMO’s financial records. This Agreement does not limit or modify VF’s audit rights under the License Agreement. To the extent any CMO audits hereunder require additional costs payable to such CMO under the applicable CMO agreement, [***].
CCX will supply on an annual basis a copy of the Annual Product Review Report (complying with the US APR and EU PQR requirements) which includes all Product data and its control, including release test results, complaint test results, and all deviations or investigations (in manufacturing, testing, and storage), that VF reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that VF is required to file with any Regulatory Authority in the Territory. Due date for the report is [***] months after the review period. Any additional data or report requested by VF beyond the scope of cGMPs and customary national requirements, including Continuous Process Verification data, will be subject to an additional fee at costs to be agreed upon between CCX and VF.
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Manufacturing and Supply Agreement
The Parties’ responsibilities for carrying out regulatory activities under or in connection with this Agreement shall be as specified in Section 5 of the License Agreement.
ARTICLE 8
TERM AND TERMINATION
This Agreement will become effective as of the Effective Date and will continue until the expiration or termination of the License Agreement, unless terminated earlier by one of the Parties in accordance herewith. Any expiration or termination of this Agreement will have no effect on the Parties’ obligations under the License Agreement.
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(e) |
This Agreement may be terminated by mutual agreement of the Parties. |
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(g) |
This Agreement may be terminated by either Party in the event that a force majeure event as further described in Article 13.5 lasts [***] months as of its occurrence. |
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(a) |
If this Agreement is terminated for any reason, then: |
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(i) |
If the Agreement is terminated (i) by VF, for CCX’s material breach pursuant to Section 8.2(a), (ii) by VF, for CCX insolvency or bankruptcy pursuant to Section |
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Manufacturing and Supply Agreement
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS
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9.1 |
Authority. |
Each Party covenants, represents, and warrants that it has the full right and authority to enter into this Agreement and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.
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9.2 |
CCX Warranties. |
CCX covenants, represents, and warrants that:
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Manufacturing and Supply Agreement
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(a) |
It or its CMOs have been granted and will maintain all licenses necessary to perform its obligations hereunder; |
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(b) |
It or its CMOs will perform the Manufacturing Services using an adequate number of skilled, trained and qualified individuals; with due care, skill, judgment and diligence, in a competent, workmanlike manner and in accordance with the Specifications, cGMPs, and Applicable Laws and that level of care and skill ordinarily exercised by other professional manufacturers in similar circumstances; |
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(d) |
Any CCX Intellectual Property used by CCX to perform the Manufacturing Services (i) is CCX’s or its Affiliate’s unencumbered property, (ii) may be lawfully used by CCX, and (iii) does not infringe and will not infringe any Third Party Rights; |
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(e) |
It will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); |
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(f) |
It does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; |
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(h) |
All documents to be provided to VF in relation with the Manufacturing and the API, Components and Bulk Drug Product are accurate; |
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(i) |
It will convey good and clear title to the Bulk Drug Product supplied hereunder; and |
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(j) |
At the time of delivery to VF, the Bulk Drug Product will be free from interest, lien, encumbrance and any other kind of security. |
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9.3 |
Permits. |
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9.4 |
Limited Warranties. |
CCX MAKES NO WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT.
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Manufacturing and Supply Agreement
CCX MAKES NO WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR CONDITION OF MERCHANTABILITY FOR THE BULK DRUG PRODUCTS.
ARTICLE 10
INDEMNITIES
Except for a breach of Article 11, Section 13.8 or for a Party’s willful misconduct, under no circumstances whatsoever will either Party be liable to the other in contract, tort, negligence, breach of statutory duty, or otherwise for any indirect loss of profits, of production, of anticipated savings, of business, of goodwill, or costs of any other consequential damages. For greater certainty, claims under Articles 10.3 and 10.4 will not limited by this provision.
CCX hereby agrees to defend, indemnify and hold harmless VF, VF's Affiliates and any sublicensees and their respective directors, officers, employees and agents (each, a "VF Indemnitee") from and against any and all liabilities, expenses and losses, including reasonable legal expenses and attorneys' fees ("Losses"), to which any VF Indemnitee may become subject as a result of any alleged claim, claim, demand, action or other proceeding by any Third Party to the extent such Losses arise out of: (a) the use, handling, storage, sale or other disposition of any Bulk Drug Product by CCX or its Affiliates, (b) the negligence or willful misconduct of any CCX Indemnitee, or (c) the breach by CCX of any warranty, representation, covenant or agreement made by CCX in this Agreement; except, in each case (a)-(c), to the extent such Losses arise out of the negligence or willful misconduct of any VF Indemnitee or the material breach by VF of any warranty, representation, covenant or agreement made by VF in this Agreement or the Quality Agreement.
VF hereby agrees to defend, indemnify and hold harmless CCX, its Affiliates and their respective directors, officers, employees and agents (each, a "CCX Indemnitee") from and against any and all Losses to which any CCX Indemnitee may become subject as a result of any alleged claim, claim, demand, action or other proceeding by any Third Party to the extent such Losses arise out of: (a) the, use, handling, storage, sale or other disposition of any Product by VF or its Affiliates or sublicensees, (b) the negligence or willful misconduct of any VF Indemnitee, or (c) the breach by VF of any warranty, representation, covenant or
22
Manufacturing and Supply Agreement
agreement made by VF in this Agreement; except, in each case (a)-(c), to the extent such Losses arise out of the negligence or willful misconduct of any CCX Indemnitee or CCX’s CMO or the material breach by CCX or CCX’s CMO of any warranty, representation, covenant or agreement made by CCX in this Agreement or the Quality Agreement.
A Party that intends to claim indemnification under this Article 10 (the "Indemnitee") shall promptly notify the indemnifying Party (the "Indemnitor") in writing of any Third Party claim, demand, action or other proceeding (each, a "Claim") in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense or settlement thereof. The Indemnitee may participate at its expense in the Indemnitor's defense of and settlement negotiations for any Claim with counsel of the Indemnitee's own selection. The indemnity arrangement in this Article 12 shall not apply to amounts paid in settlement of any action with respect to a Claim, if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Third Party Claim shall only relieve the Indemnitor of its indemnification obligations under this Article 10 if and to the extent the Indemnitor is actually prejudiced thereby. The Indemnitee shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any action with respect to a Claim covered by this indemnification.
The provision of Section 13 of the License Agreement “Confidentiality” shall apply in all respects to Confidential Information shared under this Agreement.
ARTICLE 12
DISPUTE RESOLUTION
The provisions of Section 15 of the License Agreement “Dispute Resolution” shall apply to all disputes that arise under this Agreement.
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Manufacturing and Supply Agreement
ARTICLE 13
MISCELLANEOUS
Each Party will maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that Party under this Agreement through the term of this Agreement and for a period of [***] years thereafter. This insurance will have policy limits of not less than (i) $[***] for each occurrence for personal injury or property damage liability (inclusive of any umbrella liability insurance policy); and (ii) $[***] in the aggregate per annum for product and completed operations liability. If requested each Party will give the other a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. Each Party will further provide for a minimum of [***] days’ written notice to the other Party of a cancellation of the insurance except for non-payment of premium. If a Party is unable to maintain the insurance policies required under this Agreement through no fault of its own, then the Party will forthwith notify the other Party in writing and the Parties will in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances.
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13.2 |
Independent Contractors. |
The Parties are independent contractors and this Agreement will not be construed to create between CCX and VF any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners, or any similar relationship, the existence of which is expressly denied by the Parties.
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13.3 |
No Waiver. |
Neither Party’s failure to require the other Party to comply with any provision of this Agreement will be deemed a waiver of the provision or any other provision of this Agreement.
The provisions of Section 16.5 of the License Agreement shall apply to any proposed assignment of rights or duties under this Agreement.
Each Party shall be excused from liability for the failure or delay in performance of any obligation under this Agreement (other than failure to make payment when due) by reason of any reasonably unforeseeable event beyond such Party's reasonable control including but not limited to Acts of God, fire, flood, explosion, earthquake, pandemic flu, or other natural forces, war, civil unrest, acts of terrorism, accident, destruction or other casualty, any lack or failure of transportation facilities resulting from any of the foregoing conditions or events, or any other event similar to those enumerated above. Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the Party has not caused such event(s) to occur. Notice of a Party's failure or delay in performance due to force majeure must be given to the other Party within [***] days after its occurrence. All delivery dates under this Agreement that have been affected by force majeure shall be tolled for the duration of such force majeure. In no event shall any Party be required to prevent or settle any labor disturbance or dispute.
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Manufacturing and Supply Agreement
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13.6 |
Notices. |
Any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to the other Party by personal delivery or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses or electronic mail addresses set forth below:
ChemoCentryx, Inc.
000 Xxxxx Xxxxxx
Xxxxxxxx Xxxx, XX 00000
Attention: [***]
Email address: [***]
With a copy to:
ChemoCentryx, Inc.
000 Xxxxx Xxxxxx
Xxxxxxxx Xxxx, XX 00000
Attention: [***]
Email address: [***]
If to VF
Vifor Fresenius Medical Care Renal Pharma Ltd.
Xxxxxxxxxxxxx 00, 0000 Xx. Xxxxxx
Attention: [***]
With a copy to:
Vifor Pharma Management AG
Xxxxxxxxxxxxxx 00
Attention: [***]
Facsimile: [***]
or to any other addresses or electronic mail addresses given to the other Party in accordance with the terms of this Section 13.6. Notices or written communications made or given by personal delivery, or electronic mail will be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five days after being deposited in the United States, Canada, or European Union mail, postage prepaid or upon receipt, whichever is sooner.
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13.7 |
Severability. |
If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.
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Manufacturing and Supply Agreement
Ownership of any and all Inventions conceived or reduced to practice solely by a Party or such Party’s employees, consultants, or contractors (including CMOs) or jointly by the Parties or the Parties’ employees, consultants or contractors (including CMOs) in the course of activities performed under or contemplated by this Agreement, any and all Intellectual Property therein, and any and all Patent applications and Patents resulting therefrom shall be subject to the provisions of Article 10 of the License Agreement.
This Agreement, together with the License Agreement and the Quality Agreement, constitutes the full, complete, final and integrated agreement between the Parties relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings concerning the subject matter hereof. Any modification, amendment, or supplement to this Agreement must be in writing and signed by authorized representatives of both Parties. In case of conflict, the prevailing order of documents will be this Agreement and the Quality Agreement.
No terms, provisions or conditions of any purchase order or other business form or written authorization used by VF or CCX will have any effect on the rights, duties, or obligations of the Parties under or otherwise modify this Agreement, regardless of any failure of VF or CCX to object to the terms, provisions, or conditions unless the document specifically refers to this Agreement and is signed by both Parties.
For greater certainty, nothing in this Agreement will confer or be construed as conferring on any third Party any benefit or the right to enforce any express or implied term of this Agreement.
This Agreement may be executed in two or more counterparts, by original, facsimile or “pdf” signature, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
The terms of Section 11.2(b) and (c) of the License Agreement shall apply to CCX, its CMOs and VF with respect to all activities under this Agreement.
This Agreement and will be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflicts of laws.
[Signature page to follow]
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Agreement as of the Effective Date.
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Manufacturing and Supply Agreement
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By: |
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/s/ Xxxxxx Xxxxxx |
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Name: |
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Xxxxxx Xxxxxx |
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Title: |
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President, CEO |
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Date: |
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2020-10-29 |
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VIFOR FRESENIUS MEDICAL CARE RENAL |
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PHARMA LTD. |
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By: |
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/s/ Xxxxx Xxxxx |
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Name: |
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Xxxxx Xxxxx |
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Title: |
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Head of Global Supply Chain |
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Date: |
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29-Okt-20 |
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By: |
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/s/ Xxxx Xxxxxxx Xx Xxxxxxxxxx Xxxxxxxxx |
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Name: |
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Xxxx Xxxxxxx Xx Xxxxxxxxxx Xxxxxxxxx |
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Title: |
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Head Legal & Compliance |
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Date: |
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29-Oct-20 |
27
Manufacturing and Supply Agreement
SCHEDULE A
BULK DRUG PRODUCT SPECIFICATIONS
[***]
TRANSFER PRICE
The following cost items shall be included in the “Cost of Goods” (as such term is defined in the License Agreement) for the Products
[***]
The following cost items shall not be included in the Cost of Goods for the Products:
[***]
SCHEDULE C
[***]
SCHEDULE D
LIST OF APPROVED CMOs (including their affiliates)
[***]
Patheon Pharmaceuticals Inc. (0000 Xxxx Xxxxxxxxx Xxxx, Xxxxxxxxxx, Xxxx 00000 XXX)
Hovione LLC (40 Xxxx Xxxxx Xxxx Xxxxxxx, XX 00000 XXX)
[***]
[***]
[***]
Technical Disputes which cannot be resolved by negotiation as provided in Article 12 will be resolved in the following manner:
1.Appointment of Expert. Within [***] Business Days after a Party requests under Article 12 that an expert be appointed to resolve a Technical Dispute, the Parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the Parties are unable to so agree within the [***] Business Day period, or if there is a disclosure of a conflict by an expert under Paragraph 2 hereof which results in the Parties not confirming the appointment of the expert, then an expert (willing to act in that capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association.
2.Conflicts of Interest. Any person appointed as an expert will be entitled to act and continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment (or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the Parties will, after the disclosure, have confirmed his appointment.
3.Not Arbitrator. No expert will be deemed to be an arbitrator and the provisions of the American Arbitration Act or of any other applicable statute (foreign or domestic) and the law relating to arbitration will not apply to the expert or the expert’s determination or the procedure by which the expert reaches his determination under this Schedule E.
4.Procedure. Where an expert is appointed:
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(e) |
Final and Binding. The determination of the expert will, except for fraud or manifest error, be final and binding upon the Parties. |
For greater certainty, [***] and further that nothing in this Agreement (including this Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
