Manufacturing and Supply Agreement, effective as of October 29, 2020 between the Registrant and Vifor Fresenius Medical Care Renal Pharma Ltd

Definitions.

Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations;

EudraLex - Volume 4 Good Manufacturing Practices Guidelines published by the European Commission relating to Directive 2017/1572 (art. 2); and

Division 2 of Part C of the Food and Drug Regulations (Canada);

Manufacturing specifications, directions, instructions and packaging processes for the API, Components and Bulk Drug Product;

Storage requirements for API, Components and Bulk Drug Product;

All environmental, health and safety information for the API, Components and Bulk Drug Product, including material safety data sheets;

The drug product composition packaging specifications and shipping requirements for the Bulk Drug Product; and

The Specifications will include regulatory compliance obligations, as provided in this Agreement and in the Quality Agreement.

Currency.

Sections and Headings.

Singular Terms.

Schedules and Exhibits.

Manufacturing and Supply Services.

Sourcing, Manufacturing and Supply of Bulk Drug Product. CCX shall be responsible for sourcing Components and API, and for the Manufacture and supply to VF of the Bulk Drug Product in a professional manner in full compliance with industry standard and that level of care and skill ordinarily exercised by other professional manufacturers in similar circumstances and in accordance with the Specifications, applicable laws, the Quality Agreement and the terms and conditions of this Agreement, pursuant to individual purchase orders placed by VF. CCX shall use and ensure that its CMO uses the necessary and appropriate machinery and equipment and its personnel shall be adequately selected, trained and monitored for manufacturing and supplying the Bulk Drug Products. In case of any intended change to the equipment used for Manufacturing, the change control process set forth in the Quality Agreement shall be followed. CCX shall provide VF with reasonable opportunities to review and provide comment upon any proposes CMO agreement(s) which CCX shall reasonably execute.

Subcontractors. CCX shall not be entitled to subcontract any Manufacturing Services hereunder to any subcontractor that is not an approved CMO without VF’s prior written consent. The Quality Agreement sets forth further stipulations to be abided by regarding subcontracting for Manufacturing Services. In any case, CCX remains responsible and fully liable for any acts or omissions of its subcontractors (including any CMO) in accordance with the provisions of Section 7.1 of the License Agreement. For greater certainty, a list of the agreed CMOs on the Effective Date is attached hereto as Schedule D and shall be amended by the Parties from time to time, following discussions at the JMC.

Further Assistance. CCX shall provide and shall cause any CMO to provide all such assistance, documents and information as VF or any of its Affiliates may reasonably request in connection with obtaining and maintaining Regulatory Approvals regarding the Product with any relevant Regulatory Authorities of any country in the Territory.

Authorizations and Permits. CCX warrants that it and its CMOs hold throughout the term of this Agreement at its own cost all necessary authorizations, licenses and permits for all activities performed under this Agreement by CCX and its CMOs, respectively, including without limitation with respect to Manufacture of all API, Components and Bulk Drug Products to be sold in the Territory, from the competent Regulatory Authorities, including but not limited to a valid cGMP certificate. CCX shall provide [***] and upon VF’s request all customary confirmations and authorizations that are necessary or useful for the registration and commercialization of the Product by VF.  Without prejudice to any of VF’s other rights under this Agreement, CCX shall inform VF promptly in writing in the event any such authorization is not obtained timely or is withdrawn or otherwise under investigation.

Quality Control and Quality Assurance. CCX will perform or have its agents perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to VF will be the responsibility of CCX’s quality assurance group.  CCX will perform its Batch review and release responsibilities in accordance with CCX’s and or its CMO’s standard operating procedures, cGMP and the Specifications. Each time CCX ships Bulk Drug Products to VF, it will give VF for each Batch of Bulk Drug Products a certificate of analysis and certificate of compliance (see Batch certificate requirements pursuant to European guideline EMA/INS/MRA/387218) including [***] Bulk Drug Product samples and a statement that the Batch has been manufactured and tested in accordance with Specifications and cGMPs. In the case of major deviations, critical deviations or out-of-Specification (“OOS”) investigations, a copy of the respective reports will be supplied to VF. Copies (e.g. as pdf) of Batch documents are sent to VF upon request or in accordance with the Quality Agreement. VF will have the sole responsibility for the release of Products to the market in the Territory. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of CCX or its CMO. VF, as applicable will be permitted to review and comment on the form and style of all Batch documents prior to initiation of Manufacturing Services and will have the right to use the Batch documents as required for any Regulatory filing ascribed to it in the License Agreement or otherwise to meet VF’s obligations under Applicable Law. Specific Bulk Drug Product related information contained in the Batch documents is CCX’s property.

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.  

Additional Services. If VF requests services other than those contemplated herein (such as qualification of a new packaging configuration or shipping studies, or validation of alternative Batch sizes), CCX will provide a good faith and commercially reasonable written quote of the fee for the additional services and VF will advise CCX whether it wishes to have the additional services performed by CCX. The scope of work and fees will be set forth in a separate agreement signed by the Parties. The terms and conditions of this Agreement will apply to these services.

Safety Stock. To ensure continuity of supply CCX or its CMO’s will manufacture and store a reasonable quantity of safety stock of the components and API at the Manufacturing Sites (the “Safety Stock”).  

Quality Agreement. The Parties will negotiate in good faith to enter into a Quality Agreement within following three months as the Effective Date, which will govern the quality assurance obligations of the Parties with respect to the Manufacture and supply of the Bulk Drug Product.  In the event of a discrepancy between the provisions of the Quality Agreement and the provisions of this Agreement, the provisions of the Quality Agreement shall control with respect to terms governing quality of the Bulk Drug Product and the provisions of this Agreement shall control with respect to all other terms.

Continuous Improvement.

Payment

Pricing.

Payment. The purchase price charged by CCX for costs associated with the Manufacture of the Bulk Drug Product ordered by VF under this Agreement shall be the Transfer Price. CCX shall determine the Transfer Price in accordance with Section 7.3 of the License Agreement, including GAAP or IFRS, as applicable. Upon delivery of the Bulk Drug Product in accordance with Section 5.4, CCX may invoice VF the Transfer Price for the type and quantity of the Bulk Drug Product delivered.  The Transfer Price payable by VF for the Bulk Drug Product delivered in each Year will be calculated by capsule on the basis of the number of Batches of the Bulk Drug Product forecasted to be manufactured by CCX in such Year, as set forth in VF’s Rolling Forecast submitted [***] pursuant to Section 5.1(b).  On an annual basis, CCX shall determine such Transfer Price and deliver notice thereof to VF by [***].  Such Transfer Price shall take effect and be deemed the Transfer Price for the following Year (commencing January 1 and continuing until December 31 of such Year).  VF shall pay the undisputed amount set forth in each original (i.e., not a copy) invoice delivered by CCX electronically to VF under this Section 4.1 within [***] days of receipt of such invoice. Any term or condition in an invoice or other document furnished by CCX that is inconsistent with the terms and conditions of this Agreement or in addition to the terms and conditions of this Agreement, shall not be binding on VF.

Reconciliation. On an annual basis and as part of the Transfer Price notice delivered by CCX to VF pursuant to Section 4.1(a), CCX shall perform a reconciliation to determine the actual Transfer Price for the Bulk Drug Product delivered to VF by CCX from [***] (the “Actual Transfer Price”).  Notwithstanding the foregoing, for calendar year 2021, the Actual Transfer Price shall be calculated based on the Bulk Drug Product delivered to VF by CCX from [***] based on the Rolling Forecast submitted by VF on or before [***], pursuant to Section 5.1(b).  If the Transfer Price paid to CCX for the Bulk Drug Products delivered in such time period is less than the Actual Transfer Price for such Bulk Drug Products, the difference between such amounts will be factored in the Transfer Price for the following Year (commencing January 1 and continuing until December 31 of such Year). Likewise, if the Transfer Price payments made to CCX by VF for the Bulk Drug Products delivered in such time period exceeds the Actual Transfer Price for such Bulk Drug Products, the difference between such amounts will be factored in the Transfer Price for the following Year (commencing January 1 and continuing until December 31 of such Year).  

Manner of Payment.

Disputed Amounts.

Taxes.  

Cooperation and Coordination.  The Parties acknowledge and agree that it is their mutual objective and intent to appropriately calculate and minimize, to the extent feasible and legal, taxes payable with respect to any payments under this Agreement and that they shall use commercially reasonable efforts to cooperate and coordinate with each other to achieve such objective.  Without limiting the generality of the foregoing, the Parties shall use  commercially reasonable efforts to cooperate and coordinate with each other in completing and filing documents required under the provisions of any Applicable Laws (including treaties) in connection with the making of any required tax payment or withholding payment, in connection with a claim of exemption from, or entitlement to, a reduced or zero rate of withholding or in connection with any claim to a refund of or credit for any such payment.

Payment of Tax.  All payments made by VF to CCX pursuant to this Agreement shall be made without reduction for any taxes, charges or remittance fees.  If Applicable Laws require that taxes be deducted and withheld from a payment made pursuant to this Agreement, the remitting Party shall (a) deduct those taxes from the payment; (b) pay the taxes to the proper taxing authority; and (c) send evidence of the obligation together with proof of payment to the other Party promptly following that payment.  VF shall be responsible for the payment of any taxes (including VAT, sales and use taxes and excluding income or franchise taxes), customs and excise duties incurred by VF with respect to the sale or importation of the Product by VF in the Territory.

Tax Residence Certificate. A Party receiving a payment pursuant to this Agreement shall provide the remitting Party appropriate certification from relevant governmental authorities that such Party is a tax resident of that jurisdiction, if such receiving Party wishes to claim the benefits of an income tax treaty to which that jurisdiction is a Party.  Upon the receipt thereof, any deduction and withholding of taxes shall be made at the appropriate treaty tax rate.

Assessment. Either Party may, at its own expense, protest any assessment, proposed assessment, or other claim by any governmental authority for any taxes, interest or penalties or seek a refund of such amounts paid if permitted to do so by Applicable Laws.  The Parties shall cooperate with each other in any protest or refund by providing records and such additional information as may reasonably be necessary for a Party to pursue such protest or refund.

Records.

Financial-Audit Rights.

Interest.

Orders and Forecasts.

Long Term Forecast. Promptly after the execution of this Agreement, VF will give CCX a non-binding three-year forecast of VF’s volume requirements for the Bulk Drug Product for each Year during the term of this Agreement (the “Long Term Forecast”).  The Long Term Forecast will thereafter be updated each Year on [***].  If CCX is unable to accommodate any portion of the Long Term Forecast, it will notify VF within [***] days of receiving the Long term Forecast or any update and the Parties will agree on any revisions to the forecast.

Rolling 18 Month Forecast.  Promptly after the execution of this Agreement, VF will give CCX a written 18-month forecast of the volume of Bulk Drug Product that VF expects to order in the first 18 months of commercial manufacture of the Bulk Drug Product (the “Initial Forecast”). On a rolling monthly basis during the term of this Agreement, VF will issue an updated 18 month forecast on or before the first day of each month (the Initial Forecast and each updated 18 month forecast are a “Rolling Forecast”). Each Rolling Forecast after the Initial Forecast will start on the first day of the month immediately following the date on which the Annual Forecast is to be provided. This forecast will then be updated by

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 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

the Semi Flexible Period of the then-current Rolling Forecast may only be modified within the range of [***] from month to month.

Firm Orders.

Concurrent with the delivery of the then-current Rolling Forecast, VF will issue a new firm written order in the form of a purchase order (specifying the Delivery Date or Delivery Dates that are at least [***] days after the date of the respective purchase order) (“Firm Order”) for deliveries of the Bulk Drug Products to VF, ensuring that CCX always has at least [***] days lead-time to deliver Bulk Drug Product to VF. When accepted by CCX as specified below, such Firm Order for CCX to Manufacture and deliver the agreed quantity of the Bulk Drug Products. In case of first launch, at least [***] calendar days prior to the requested initial Shipping Date of Bulk Product or as soon as practicable after the Effective Date of this Agreement, VF shall place an initial purchase order. CCXI will confirm receipt of such request and will use commercially reasonable efforts to accept and fulfill such purchase order.

Firm Orders submitted to CCX will specify VF’s purchase order number, quantities by Bulk Drug Product type, Delivery Date, and delivery location. The quantities of Bulk Drug Products ordered and Delivery Dates in those Firm Orders will be firm and binding on VF and CCX (unless rejected under Section 5.1(d)) and may not be reduced by VF or CCX except as expressly permitted in this Agreement. Expedited Firm Orders will be subject to additional fees as agreed in writing by the Parties.

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.

Acceptance of Firm Order. CCX will accept Firm Orders by sending a written confirmation to VF within [***] Business Days of its receipt of the Firm Order. The confirmation will include the Delivery Date for the Bulk Drug Product ordered. The Delivery Date may be amended by agreement of the Parties. If CCX fails to acknowledge receipt of or reject a Firm Order within the [***] Business Day period, the Firm Order will be considered to have been accepted by CCX. CCX may not reject a Firm Order other than on the basis of (i) a failure by VF to include the information required to be provided in the Firm Order under this Section; or (ii) a Firm Order that imposes requirements that conflict with this Agreement.  CCX will include in any rejection a reasonable explanation of the basis for the rejection.

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.

Minimum Orders.

Delivery and Shipping.

Delivery of Bulk Drug Products will be made [***] (Incoterms 2010) CCX’s CMO’s warehouse on the Delivery Date, provided that for any transatlantic shipments title, risk of loss or of damage to Bulk Drug Products should remain with CCX until the Bulk Drug Products are [***]. CCX will engage a third party courier to move the Bulk Drug Products from Patheon to the VFMCRP appointed transatlantic carrier. Shipment expenses to be expressly included in Transfer Price. CCX will not be entitled to deliver partial shipments of the Bulk Drug Products unless expressly authorized by VF in writing. With each shipment, CCX will provide the documents as set forth in the Quality Agreement and otherwise as required for shipment.  CCX will provide up to [***] days’ storage in accordance with the applicable Specifications for Bulk Drug Product after release and VF’s receipt of information required for shipment to enable VF to arrange shipping from CCX’s CMO’s warehouse.

Subject to Section 13.5, and except for shelf life deficiencies resulting from delays attributable to VF or from agreed deviation investigations, CCX will deliver each Bulk Drug Product together with its release certificates with a shelf life of at least [***] of the total shelf life of the Bulk Drug Product.

If CCX anticipates to be unable to deliver the Bulk Drug Product to VF in accordance with a confirmed Firm Order for whatever reason, CCX will immediately inform VF thereof, and without prejudice to any of VF’s rights under this Agreement, the Parties will agree on the necessary arrangements for minimizing the possible loss and damage which VF may suffer from the delay in delivery. Any deviation from a Delivery Date already set forth in a confirmed Firm Order is subject to VF’s prior approval. If VF provides this approval, VF will have no claims against CCX as a result of the rescheduled Delivery Date. If CCX does not deliver the Bulk Drug Products ordered by means of a confirmed Firm Order (for any reason other than as a result of force majeure event), CCX will promptly notify VF about the reasons for delay.

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.

Liquidated Damages For Late Delivery.

If Bulk Drug Product delivery occurs [***] days after the applicable Delivery Date, CCX pays [***];

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;

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;

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;

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

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;

Supply Failure; Technology Transfer

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).

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, [***].  

Product Claims

Product Claims. VF has the right to reject any portion of or all (to the extent reasonable) of any shipment of Bulk Drug Product that was not Manufactured in accordance with the Specifications, the Marketing Authorisation Dossier (“MAD”), Manufacturing Batch record (“MBR”), cGMPs, or Applicable Laws, without invalidating any remainder of the shipment that was not rejected. VF will inspect the Bulk Drug Product manufactured by CCX upon receipt and will give CCX written notice (a “Deficiency Notice”) of all claims for Bulk Drug Product that was not manufactured in accordance with the Specifications, MAD or MBR, cGMPs, or Applicable Laws, within [***] days after VF’s receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Bulk Drug Product, within [***] days after discovery by VF, but not after the expiration date of the Product). Other than with respect to defects not reasonably susceptible to discovery, if VF fails to give CCX the Deficiency Notice within the applicable [***] day period, then the delivery will be considered to have been accepted by VF on the [***]^th day after delivery or discovery, as applicable. CCX will have no liability for any deficiency for which it has not received notice within the applicable [***]-day period.

Determination of Deficiency. Upon receipt of a Deficiency Notice, CCX will have [***] days to advise VF by notice in writing that it disagrees with the contents of the Deficiency Notice. If VF and CCX fail to agree within [***] days after CCX’s notice to VF as to whether any Bulk Drug Product identified in the Deficiency Notice was not Manufactured in accordance with the Specifications, MAD or MBR, cGMPs, or Applicable Laws, the Parties will engage a mutually-acceptable independent Third Party to perform testing and investigation to resolve the deficiency and liability issues.  The Parties agree to accept the independent Third Party’s conclusive determination and identify if any aspect of the Third Party testing and investigation proves inconclusive, executives from both Parties will meet and use good faith efforts to resolve any remaining deficiency and liability issues.  If the JMC is unable to resolve the dispute within [***] days, the dispute will be handled as a technical dispute under Exhibit A.

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.

Product Recalls and Returns.

Records and Notice. CCX, its CMO’s and VF will each maintain records necessary to permit a Recall of any Product delivered to VF or customers of VF. Each Party will promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product. Upon receiving this notice or upon this discovery, each Party will confirm which Product batches in its possession or control, as applicable, are likely to be non-conforming and stop making any further shipments of any Product batch in its possession or control that is likely to be non-conforming until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, will be made and implemented by VF. “Recall” will mean any action (i) by VF to recover title to or possession of quantities of the Product sold or shipped to Third Parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any Regulatory Authorities to detain or destroy any of the Product. Recall will also include any action by either Party to refrain from selling or shipping quantities of the Product to Third Parties which would be subject to a Recall if sold or shipped.

Recalls. If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) VF determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, CCX will co-operate as reasonably required by VF, having regard to all applicable laws and regulations.

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.

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).

CCX’s Responsibility for Defective and Recalled Products.

Defective Product. If VF rejects Bulk Drug Product under Section 6.1 and the deficiency is determined to have arisen from CCX’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs or Applicable Laws, CCX will [***] for the defective Bulk Drug Product. If VF previously paid for the defective Bulk Drug Product, CCX will promptly, [***], either: (i) replace the Bulk Drug Product with conforming Bulk Drug Product within the following [***] months, as of rejection by VF, without VF being liable for payment therefor under Section 3.1. or (ii) [***].

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 [***].

Except as set forth in Sections 6.3 (a) and (b) above and Sections 6.4 and 6.5 below, CCX will not be liable to VF nor have any responsibility to VF for any deficiencies in, or other liabilities associated with, any Bulk Drug Product manufactured by it (collectively, “Product Claims”) to the extent the Product Claim (i) [***], (ii) [***], (iii) [***], or (iv) [***].

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.  

Disposition of Defective or Recalled Products.

Healthcare Provider or Patient Questions and Complaints.

Sole Remedy.

Deviations / Change Control.

Governmental Authorities.

Records and Accounting by CCX.

Audit.

cGMP-type Audit.

Inspections.

PAI Inspections. CCX will support and will ensure CCX’s CMO`s will support all Product Approval Inspections (“PAIs”) of the FDA or any equivalent regulatory inspection for other jurisdictions (where applicable) and provide a copy of the resulting reports to VF [***].

Notification of Regulatory Inspections. CCX will notify VF within [***] Business Day of receipt of notice of any planned inspection or audit by any Governmental Authority specifically involving the API, Components and Bulk Drug Products and/or the Manufacturing Sites and will notify VF promptly regarding any inspection or audit that is unannounced. CCX will permit VF and VF’s licensees to be present at the Manufacturing Site for these audits and inspections but VF will not be permitted to actively participate in the audit/inspection or onsite responses thereto. CCX will promptly provide to VF copies of any Governmental Authority correspondence relating to Manufacturing hereunder, and more in particular FDA Forms 483, the response to the Form 483 and other notices of inspectional observations, warning letters, untitled letters, GMP compliance inspection notifications/results, GMP certificates and other similar actions and correspondence including from any other Regulatory Authority which could reasonably affect the regulatory status of the API, Components and Bulk Drug Products. CCX will provide VF with copies of all proposed responses to the regulatory actions and correspondence with reasonable time for VF to review prior to submission. CCX will duly consider any VF comments prior to submitting the responses to any governmental agency.

Reports.

Regulatory Filings.

Term.

Termination.

Either Party at its sole option may terminate this Agreement upon written notice where the other Party has failed to remedy a material breach of any of its representations, warranties, or other obligations under this Agreement within 45 days following receipt of a written notice (the “Remediation Period”) of the breach from the aggrieved Party that expressly states that it is a notice under this Section 8.2(a) (a “Breach Notice”).

Either Party may, at its sole option, immediately terminate this Agreement upon written notice, but without prior advance notice, to the other Party if: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; or (iii) this Agreement is assigned by such other Party for the benefit of creditors.

VF may terminate this Agreement upon [***] days’ prior written notice if the Product (i) the EMA or PDMA does not approve an application for Regulatory Approval for the Product, or issue a letter indicating that such an application is approvable within [***] years after VF (or its sublicensee) submits such application; (ii) VF (or its sublicensee) withdraws its application for Regulatory Approval for the Product in the E.U. or Japan; (c) VF (or its sublicensee) withdrawns the Product for sale in the E.U. or Japan. But if this occurs, VF must still fulfill all of its obligations under Section 8.3 below.  

Commencing five (5) years after the first Regulatory Approval of the Product, VF may terminate the Agreement without liability (except for its obligations under Section 8.3) upon six months’ prior written notice for any reason.

This Agreement may be terminated by mutual agreement of the Parties.

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.

Obligations on Termination.

If this Agreement is terminated for any reason, then:

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

8.2(b), or (c) by either Party for force majeure pursuant to Section 8.2(g), to the extent requested by VF, the Parties will work together to ensure smooth transition of the Manufacturing Services from CCX to VF or a Third Party determined by VF, and CCX will provide VF or a VF designated manufacturer reasonable services, information and instruction on a reasonable time and materials basis regarding the technology, processes and techniques necessary to enable VF or VF’s designated manufacturer to manufacture the Bulk Drug Product;

[***], VF will take delivery of and pay for all undelivered Bulk Drug Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order if the manufacture of the Bulk Drug Product started before termination or expiration of this Agreement, at the Transfer Price in effect at the time the Firm Order was placed;

To the extent requested by VF, for [***] months after completion, expiration or termination of this Agreement (the “Rampdown Period”), CCX will continue to provide VF with the applicable Bulk Drug Product in accordance with the terms of this Agreement;

[***], VF will purchase, [***] within [***] days after the end of the Rampdown Period, the inventory applicable to the Bulk Drug Products which was purchased, maintained or produced by CCX in contemplation of filling Firm Orders or in accordance with Section 5; and

[***], VF will satisfy the [***] under CCX’s orders with suppliers of Components, that CCX was not able to mitigate using commercially reasonable efforts (e.g., using Inventory for other purposes or cancelling orders for Components) within [***] month after the end of the Rampdown Period, if the orders were made and not cancelable by CCX in reliance on Firm Orders or in accordance with Section 5.2.

Any termination or expiration of this Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the Parties may have under this Agreement. Completion, termination or expiration of this Agreement for any reason will not affect the obligations and responsibilities of the Parties under Articles 4 (with respect to any payments outstanding), 6.6, 8.3, 10, 11, 13.1 and 13.3, all of which survive any completion, termination or expiration.

Authority.

CCX Warranties.

It or its CMOs have been granted and will maintain all licenses necessary to perform its obligations hereunder;

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;

The Bulk Drug Products will be manufactured in accordance with cGMP and the Quality Agreement and will meet the Specifications for the duration of the Product shelf life, except to the extent the failure to meet the Specifications is not due to CCX’s fault;

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;

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);

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;

At the time of delivery to VF, the Bulk Drug Product will have been Manufactured, handled and stored 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 Applicable Laws, cGMP, and in compliance with the Specifications (including in compliance with the packing and labeling indications contained therein) and the Quality Agreement and will not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws;

All documents to be provided to VF in relation with the Manufacturing and the API, Components and Bulk Drug Product are accurate;

It will convey good and clear title to the Bulk Drug Product supplied hereunder; and

At the time of delivery to VF, the Bulk Drug Product will be free from interest, lien, encumbrance and any other kind of security.

Permits.

VF will be solely responsible for obtaining or maintaining, on a timely basis, any permits or other regulatory approvals for the Products or the Specifications, including, without limitation, all marketing and post-marketing approvals.

CCX will maintain at all relevant times all governmental permits, licenses, approval, and authorities required to enable it or its CMO to lawfully and properly perform the Manufacturing Services in accordance with this Agreement, the Quality Agreement and cGMP.

Limited Warranties.

Consequential and Other Damages.

Limitation of Liability.

Defective Product. CCX’s maximum aggregate liability to VF for any obligation to (i) refund, offset or replace any defective Product under Section 6.3(a) or (ii) replace any recalled Products under Section 6.3(b), will not exceed [***] for the defective or recalled Product as applicable. This Section 10.2(a) will not be subject to Section 10.2(b). For clarity, any CCX liability for VF’s out of pocket expenses of a Recall or Product return under Section 6.3(b) will be subject to Section 10.2(b) and not this Section 10.2(a).

Maximum Liability. [***], CCX’s maximum liability to VF under this Agreement for any reason whatsoever, including, without limitation, any liability arising under Section 6.3(b) relating to the expenses of a Recall or Product return or Section 2.2 of this Agreement or resulting from any and all breaches of its representations, warranties, or any other obligations under this Agreement will not exceed the greater of (i) [***], (ii) [***], and (iii) [***].

Indemnification by CCX.

Indemnification by VF.

Procedure.

Insurance.

Independent Contractors.

No Waiver.

Assignment

Force Majeure.

Notices.

Severability.

Intellectual Property.

Entire Agreement.

Other Terms.

No Third Party Benefit or Right.

Execution in Counterparts.

Compliance.

Governing Law.

Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the Parties and that he issues the authorizations to the Parties and any relevant Third Party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within [***] Business Days (or another date as the Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.

Disclosure of Evidence. The Parties undertake one to the other to give to any expert all the evidence and information within their respective possession or control as the expert may reasonably consider necessary for determining the matter before him which they will disclose promptly and in any event within [***] Business Days of a written request from the relevant expert to do so.

Advisors. Each Party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the Parties will co-operate and seek to narrow and limit the issues to be determined.

Appointment of New Expert. If within the time specified in Paragraph 4(a) above the expert will not have rendered a decision in accordance with his appointment, a new expert may (at the request of either Party) be appointed and the appointment of the existing expert will thereupon cease for the purposes of determining the matter at issue between the Parties except if the existing expert renders his decision with full reasons prior to the appointment of the new expert, then this decision will have effect and the proposed appointment of the new expert will be withdrawn.

Final and Binding. The determination of the expert will, except for fraud or manifest error, be final and binding upon the Parties.

Costs. Each Party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the Parties.