***Certain identified information has been omitted from this exhibit because it is both not material and would be competitively harmful if publicly disclosed.***
[Redacted] Commercial Supply Agreement
(the “Agreement”)
by and between
Lonza AG
Münchensteinerstrasse 38
CH-4002 Basel
Switzerland
- hereinafter “Lonza” -
and
Allakos, Inc.
975 Island Drive, Suite 201
Redwood City, CA 94065
USA
- hereinafter “Customer” -
Effective as of 27 November 2020 (the “Effective Date”)
Table of Contents
|
| Page |
1 | Definitions and Interpretations | 1 |
2 | Performance of Services | 8 |
3 | Project Management | 11 |
4 | Quality | 12 |
5 | Insurance | 13 |
6 | Forecasting, Ordering and Cancellation | 13 |
7 | Delivery and Acceptance | 16 |
8 | Price and Payment | 18 |
9 | Intellectual Property | 19 |
10 | Warranties | 22 |
11 | Indemnification and Liability | 24 |
12 | Confidentiality | 26 |
13 | Term and Termination | 28 |
14 | Force Majeure | 30 |
15 | Notices | 30 |
16 | Miscellaneous | 31 |
Appendix A – Batch Pricing
Appendix B - Approved Third Parties
Appendix C – Cell Bank Storage Pricing
Appendix D – Additional Capacity Commitments
Recitals
WHEREAS, Customer is engaged in the development, research and sale of certain products and requires assistance in the manufacture of Product;
WHEREAS, Lonza and its Affiliates have expertise in the manufacture of products;
WHEREAS, Lonza and Customer previously entered into that certain BLA Services and Manufacturing Services Agreement dated 1st December 2017 (the “BLA Agreement”) and the 2K Development Agreement (as defined below) to provide services related to Customer’s AK002 Product;
WHEREAS, Customer wishes to engage Lonza for Services relating to the manufacture of the Product as described in this Agreement; and
WHEREAS, Lonza, and/or its Affiliate, is prepared to perform such Services for Customer on the terms and subject to the conditions set out herein.
NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the Parties intending to be legally bound, agree as follows:
1.1 | Definitions. |
“1K Commercial Supply Agreement” | means the 1K Commercial Supply Agreement dated [Redacted] between Customer and Lonza Sales AG, Lonza’s Affiliate. |
“[Redacted] Development Agreement” | means, collectively, [Redacted] Development and Manufacturing Services Agreement entered into between Lonza and Customer [Redacted] and any successor agreement thereof. |
“Affiliate” | means any company, partnership and/or other entity which directly and/or indirectly Controls, is Controlled by and/or is under common Control with the relevant Party. “Control” means the ownership of more than fifty percent (50%) of the issued share capital and/or the legal power to direct and/or cause the direction of the general management and policies of the relevant Party. |
“Agreement” | means this agreement incorporating all Appendices, as amended from time to time by written agreement of the Parties. |
“Alternate Manufacturer” | means (i) Customer and each of its Affiliates or (ii) any Third Party that, [Redacted] |
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including the applicable regulations and guidelines of any Governmental Authority and in respect of the manufacture of cGMP Batches all applicable cGMP together with amendments thereto. |
“Approval” | means a marketing approval granted by a Regulatory Authority of Product. |
“Approved Territory” | means [Redacted]. |
“Average Target Yield” | means the expected and targeted Yield for the Process at the Facility [Redacted]. |
“Batch” | means the total Product obtained from one fermentation and associated purification using the Process [Redacted]. |
“Binding Order” | means the binding commitment of both Parties in relation to the Batches and/or Services made in accordance with Clause 6.1 and/or 6.2. |
“Campaign” | means a series of cGMP Batches at the Facility. |
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“Cell Bank” | means Customer’s cell bank and/or cell stock of a rodent or human cell line in accordance with the Master Batch Record. |
“Cell Bank Storage” | means the storage of Customer’s Cell Bank in accordance with Clause 2.8. |
“Certificate of Analysis” | means a document prepared by Lonza listing tests performed by Lonza and/or approved External Laboratories pertaining to the cGMP Batch meeting the Specifications and associated test results. |
“Certificate of Compliance” | means a document prepared by Lonza: (i) listing the manufacturing date, unique Batch number and concentration of Product in such Batch; and (ii) certifying that such Batch was manufactured in accordance with the Master Batch Record and cGMP, if applicable. |
“cGMP Batches” | means any Batches which are required under the applicable Binding Order to be manufactured in accordance with cGMP. |
“Commencement Date” | means the date of removal of the vial of cells from frozen storage for the production of a cGMP Batch. |
“Confidential Information” | means Customer Information and Lonza Information, as the context requires. |
“Customer Indemnitees” | has the meaning given in Clause 11.1. |
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“Customer Materials” | means any components of Product, and/or other materials of any nature provided by Customer. |
“Dispute” | has the meaning given in Clause 16.6. |
“Effective Date” | has the meaning set forth in the Recitals. |
“EMA” | means the European Medicines Agency, or any successor agency thereto. |
“External Laboratories” | means any Third Party instructed by Lonza to undertake any Services which Lonza is not able to undertake itself as it does not form part of its business offering, Customer having been notified of the same as part of the Services proposal and having provided prior written consent to such Third Party and its designation as an External Laboratory. |
“Facility” | means Lonza’s manufacturing facilities in Visp, Switzerland and/or such other Lonza facility as may be agreed upon by the Parties in writing. |
“Failed Batch” | means any cGMP Batch that fails to conform with the Specifications and/or is not manufactured in accordance with cGMP and/or the Quality Agreement. |
“FDA” | means the United States Food and Drug Administration, or any successor agency thereto. |
“Force Majeure” | has the meaning given in Clause 14.2. |
“GS” | means the glutamine synthetase expression system of which Lonza is the proprietor. |
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“Initial Storage Term” | has the meaning given in Clause 2.8.1. |
“Intellectual Property” | means: (i) inventions (whether or not patentable), patents, trade secrets, copyrights, trademarks, trade names and domain names, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how) and any other intellectual property rights, in each case whether registered or unregistered; (ii) all applications (and/or rights to apply) for, and renewals and/or extensions of, any of the rights described in the foregoing clause (i); and (iii) all rights and applications that are similar and/or equivalent to the rights and applications described in the foregoing clauses (i) and (ii), which exist now, and/or which come to exist in the future, in any part of the world. |
“Joint Steering Committee” | has the meaning given in Clause 3.3. |
“Latent Defects” | has the meaning given in Clause 7.4.1. |
“Lonza Indemnitees” | has the meaning given in Clause 11.2. |
“Lonza Information” | means all information that is proprietary to Lonza and/or any Affiliate of Lonza and that is maintained in confidence by Lonza and/or any Affiliate of Lonza and that is disclosed by Lonza and/or any Affiliate of Lonza to Customer under and/or in connection with this Agreement, including any and all Lonza Know-How and trade secrets. |
“Lonza Know-How” | means all technical and other information relating directly or indirectly to the Process and/or the performance of the Services known to Lonza and/or its Affiliates from time to time other than Customer Information and information in the public domain. |
“Lonza Operating Documents” | means the corporate standards, standard operating procedures and standard manufacturing procedures, in each case, used |
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by Lonza for operation and maintenance of the Facility and Lonza equipment used in the Process, which may include electronic programs and files, protocols, validation documentation, and supporting documentation, but excluding any of the foregoing that are unique or specific to the Products. |
“Lonza Patent Rights” | means all patents and patent applications of any kind throughout the world relating to the Process which from time to time Lonza and/or any Affiliate of Lonza is the owner of and/or is entitled to use. |
“Lonza Responsibility” | has the meaning given in Clause 7.4.4. |
“Master Batch Record” | means the document which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of cGMP Batches. |
“New Customer Intellectual Property” | has the meaning given in Clause 9.2. |
“New General Application Intellectual
Property” | has the meaning given in Clause 9.3. |
“Price” | means the price for the Products as specified in Clause 8.1 or for other Services as set forth in an agreed upon SOW. |
“Process” | means Lonza’s and its Affiliates’ platform process for the development and production of the Product from the Cell Line, including any improvements and/or modifications thereto that are owned and/or controlled by Lonza and/or any Affiliate of Lonza from time to time. |
“Product” | means the proprietary molecule identified by Customer as AK002, to be manufactured using the Process as specified in the Specifications and the Master Batch Record. |
“Project Plan” | means the Project Plan as attached to and defined in the 2K Development Agreement. |
“Quality Agreement” | means the quality agreement entered into between the Parties [Redacted] setting out the |
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responsibilities of the Parties in relation to quality as required for compliance with cGMP. |
“Raw Materials” | means all ingredients, solvents and other components of the Product required to perform the Process and/or Services set forth in the bill of materials detailing the same (including Resins and membranes but excluding any consumables and/or wearables). |
“Raw Materials Fee” | means the procurement and handling fee [Redacted] of the acquisition cost of Raw Materials (including Resins) by Lonza that is charged to Customer in addition to the cost of such Raw Materials. |
“Receiving Party” | has the meaning given in Clause 12.1. |
“Regulatory Authority” | means the FDA, EMA and any other similar regulatory authorities as may be agreed upon in writing by the Parties. |
“Resins” | means the chromatographic media to refine and/or purify the Products, as specified in the Master Batch Record and/or Specifications. |
“Rules” | has the meaning given in Clause 16.6. |
“Separate Agreements” | means, collectively, the BLA Agreement, 2K Development Agreement, 20K Development Agreement, and 1K Commercial Supply Agreement. |
“Services” | means all or any part of the services to be performed by Lonza under this Agreement (including the manufacture of Product and as set forth in any SOW). |
“Specifications” | means the specifications of the Product agreed between the Parties which may be amended from time to time in accordance with this Agreement. |
“Storage Requirements” | means the Cell Bank storage requirements as set out in the Master Batch Record. |
“Subcontractor” | means any Third Party that Lonza uses to perform any part of the Service, including as a subcontractor and/or delegate, but excluding External Laboratories. |
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“Technology Transfer Notice” | has the meaning given in Clause 9.8.2. |
“Term” | has the meaning given in Clause 13.1. |
“Third Party” | means any party other than Customer, Lonza and their respective Affiliates. |
“Willful Breach” | means a willful refusal to perform a Party’s obligations under this Agreement, including, without limitation, if Lonza elects to provide any batch slot reserved or scheduled for Customer in the Binding Portion of any Forecast to another customer of Lonza. |
“Yield” | means the amount, in kilograms, of Product actually produced from a Batch. |
2.1 | Performance. Customer hereby retains Lonza to manufacture and supply the Product and perform other Services as set forth in and in accordance with the terms and conditions of this Agreement. Subject to Clause 2, Lonza shall itself and through its Affiliates, diligently carry out the Services and use commercially reasonable efforts to perform all Services without any material defect and according to the Binding Orders, the Specifications, the Master Batch Record and/or the applicable SOW. Lonza shall ensure that all of the Services hereunder are performed at the Facility and/or at a Subcontractor’s facility which has been approved and audited by Lonza, as applicable, unless Customer has provided its prior written consent to performance thereof at an alternate location. |
2.2 | Personnel and Subcontractors. Lonza shall retain appropriately qualified and trained personnel with the requisite knowledge and experience to perform the Services in accordance with this Agreement. Lonza may subcontract and/or delegate any of its rights and/or obligations under this Agreement to perform the Services solely with Customer’s prior written approval (such approval not to be unreasonably withheld and/or delayed), provided that such Subcontractors are appropriately and fully qualified in all respects to perform the applicable Services, that such Subcontractors are subject to obligations of confidentiality at least as stringent and as protective of Customer as those obligations of confidence and non-use imposed upon Lonza, and that such Subcontractors are subject to obligations to act diligently and in accordance with best practice in respect of cGMP manufacture as contained in this Agreement. [Redacted]. |
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2.6 | Use of GS Technology. Customer acknowledges that the Cell Line uses GS and that the GS Licence applies to in vivo clinical studies and/or any other commercial use and/or sale of the Product manufactured using the Cell Line. |
| 2.8.2 | Cell Banks stored at Lonza shall at all times remain Customer’s property (subject always to the terms of any other agreements or licenses of Customer with Lonza, and subject to any Third-Party Intellectual Property rights), save that the Cell Bank shall be subject to a lien in respect of any sums owed under any agreement by Customer to Lonza. |
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The function of the Joint Steering Committee is to ensure the ongoing communication between the Parties and discuss any issues arising under this Agreement. In addition to the function described above, the Joint Steering Committee shall also take on the following responsibilities:
| 3.3.1 | discuss and seek resolution of issues around management of the Services; |
| 3.3.2 | monitor timelines and milestones for the Services; |
| 3.3.3 | discuss and recommend any changes to the Services (although such changes will not take effect until they have been approved in writing by the Parties in accordance with Clause 16.2); and |
| 3.3.4 | discuss and seek resolution for any dispute regarding the terms of this Agreement. |
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4.1 | Quality Agreement. Responsibility for quality assurance and quality control of Product shall be allocated between Customer and Lonza as set forth in the Quality Agreement. If there is a conflict between the terms and conditions of this Agreement and the Quality Agreement, the terms and conditions of this Agreement shall prevail. Performance by Lonza of all of its obligations under the Quality Agreement will be considered covered by the Batch Price and no additional consideration is payable by Customer unless otherwise agreed between the Parties. For clarity, the foregoing does not require Lonza to provide regulatory support other than as set forth in this Agreement and the Quality Agreement. |
4.2 | Inspections and Audits. Provisions regarding inspections by Governmental Authorities and audits are set out in the Quality Agreement, and include the following: |
| 4.2.1 | Customer and its designated representatives shall have the right to witness, inspect and audit the performance of Lonza’s obligations, at the times, number of occasions and for durations set forth in the Quality Agreement and as otherwise agreed by the Parties; |
| 4.2.6 | Customer shall have the right to review the specifications, grades and vendors of all Raw Materials and components used under this Agreement to manufacture the Product at the Facility. |
4.3 | Regulatory Support and Cooperation. Lonza shall, at the Price as set forth in the 2K Development Agreement, provide Customer with regulatory support and cooperation related to the Product, the Process and seeking and maintaining Approvals as reasonably requested by Customer from time to time. |
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Each Party shall, during the Term and for [Redacted] after delivery of the last Product manufactured and/or Services provided under this Agreement, obtain and maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance including contractual liability coverage and product liability coverage in the amount of at [Redacted]. Each Party shall provide the respective other Party with a certificate of such insurance upon reasonable request.
| (a) | any Batches set forth in the Project Plan pursuant to the 2K Development Agreement or otherwise set forth in a Separate Agreement shall be manufactured in accordance with the schedule set forth in the applicable Separate Agreement; and |
| 6.1.3 | Customer will order Batches pursuant to written purchase orders. Lonza must accept Customer’s purchase orders for quantities of Batches that are consistent with the terms of this Agreement and that do not exceed the Binding Portion of agreed upon Forecasts and will use commercially reasonable efforts to accept orders exceeding such quantities. |
| 6.1.4 | [Redacted]. |
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| 6.3.1 | Lonza shall have the right to: |
| (a) | reschedule the Commencement Date of any Batch or date of commencement for any Services upon [Redacted] prior written notice to Customer, provided that the rescheduled Commencement Date for such Batch or date of commencement for such Services is [Redacted] from the Commencement Date or the original estimated Commencement Date in accordance with the applicable Binding Order; and |
| (b) | reschedule the Commencement Date of any Batch or date of commencement for any Services upon reasonable prior written notice to Customer, provided that the rescheduled Commencement Date or date of commencement is [Redacted] from the Commencement Date or date of commencement originally estimated in the Project Plan. |
If Lonza so reschedules any Batch, Lonza’s obligation to provide storage for such Batch without charge pursuant to Clause 7.3 shall extend to the later of: (i) [Redacted] after the actual Release of such Batch; or (ii) [Redacted] after the date such Batch would have been Released if the Commencement Date had not been so rescheduled.
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For the avoidance of doubt: (a) any Batches scheduled to commence [Redacted], after the date of a notice of Cancellation shall not incur any Cancellation Fee; (b) no cancellation of a Batch pursuant to any amendments to the Project Plan which the Parties may agree in accordance with the 2K Development Agreement shall constitute a cancellation and no Cancellation Fee set out in this Clause 2.8 shall apply; (c) no cancellation of a Batch by Customer as a result of a [Redacted] shall incur any Cancellation Fee; provided that [Redacted].
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| of the Joint Steering Committee at least monthly reports on Lonza’s execution of any such open action plan. |
| 7.4.3 | In the event that Lonza believes that a Batch has been incorrectly rejected for failure to conform with the Specifications, [Redacted]. Lonza may, at its expense, retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results show no failure or non-conformity to Specifications, or there exists a dispute between the Parties over the extent to which such failure and/or non-conformity to Specifications is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. The Party against whom the independent laboratory rules will be required to reimburse the other Party for shipping, storage and other similar out-of-pocket expenses incurred by the other Party in connection with such rejected Batch. |
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8.4 | Repeated Late Payments. If Customer fails to pay an undisputed invoice within [Redacted] after the due date as set out in Clause 8.3 on [Redacted] occasions, then Lonza shall have the option to change the payment terms such that [Redacted] of the Price for any stage of work shall be payable on commencement and the price for Raw Materials and Resins and the Raw Materials Fee shall also be payable [Redacted]. |
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| to any Batches for which the Commencement Date is on or after January 1 of the immediately following calendar year. |
8.8 | Yield Price Adjustment. [Redacted]. |
9.1 | Background Intellectual Property. Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, and/or interest in any Background Intellectual Property of the other Party. |
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9.4 | Further Assurances. Lonza hereby assigns to Customer all of its right, title and interest in any New Customer Intellectual Property. Lonza shall execute, and shall require its personnel as well as its Affiliates, External Laboratories and/or other contractors and/or agents and their personnel involved in the performance of the Services to execute, any documents reasonably required to confirm Customer’s ownership of the New Customer Intellectual Property, and any documents required and/or reasonably requested by Customer, but excluding any document that is Lonza Information, to apply for, maintain and enforce any patent and/or other right in the New Customer Intellectual Property. |
9.6 | License to Perform Services. Customer hereby grants Lonza a non-exclusive, revocable license to use the Customer Information, Customer Background Intellectual Property and New Customer Intellectual Property during the Term solely for the purpose of fulfilling its obligations under this Agreement. Except as express set forth in the prior sentence, Lonza receives no license, right, title or interest in or to the Product, Customer Information, Customer Background Intellectual Property and/or New Customer Intellectual Property and all such rights are reserved by Customer. |
9.7 | License to the Process and License Back to Improvements. |
| 9.7.1 | Lonza hereby grants Customer a non-exclusive, revocable (solely upon Lonza’s termination of this Agreement for Customer’s uncurable material |
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| breach of this Agreement, but if Customer contests the claim of such material breach, the license will not be revoked unless and until such uncurable material breach is determined to have occurred in accordance with Clause 16.6), worldwide license, with the right to grant sublicenses to Alternate Manufacturers, under the Lonza Information, and Lonza Background Intellectual Property incorporated into the Process to make, have made, use, sell, offer for sale and import the Product and reasonable modifications, extensions and expansions of the Product, provided such Product and reasonable modifications, extensions and expansions of the Product, but no other product, may only be made within the Approved Territory. |
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Under no condition shall Customer be permitted to use and/or disclose for any purpose [Redacted].
| 9.8.5 | Customer shall reimburse Lonza for any costs and expenses incurred by Lonza in connection with producing the documents and providing the support set forth in Clauses 9.8.3 and 9.8.4, with costs for Lonza’s internal resources charged on a man day rate based upon Lonza’s then-prevailing standard charge for technical support; provided that Lonza agrees to provide [Redacted]. |
| 9.8.6 | As part of the technology transfer, Lonza shall advise Customer of all license from and/or payment to any Third Party that Lonza has received or pays in connection with the manufacture of the Product, but excluding any license or payment applicable to the general operation and maintenance of the Facility and Lonza equipment that are not unique or specific to the Products. |
| 9.8.8 | For clarity, the technology transfer process described in this Clause 9.8 shall be instead of and not in addition to the technology transfer process described in the BLA Agreement or 2K Development Agreement for the transfer of the Process for the Product [Redacted]. The foregoing does not limit any amounts due from Customer to Lonza as set forth in Clauses 9.8.1 through 9.8.7. |
| 10.1.1 | the Services shall be performed in accordance with all Applicable Laws and this Agreement; |
| 10.1.3 | it and/or its Affiliate holds all necessary permits, approvals, consents and licenses to enable it to perform the Services at the Facility and it has the necessary corporate authorizations to enter into and perform this Agreement; |
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| 10.1.6 | Lonza has never been debarred under the Generic Drug Enforcement Act of 1992, 21 U.S.C. Sec. 335a(a) and/or (b), and/or sanctioned by a Federal Health Care Program (as defined in 42 U.S.C. § 1320 a-7b(f)), including the federal Medicare and/or a state Medicaid program, and/or debarred, suspended, excluded, and/or otherwise declared ineligible from any Federal agency and/or program. In the event that during the Term of this Agreement, Lonza becomes debarred, suspended, excluded, sanctioned, and/or otherwise declared ineligible; Lonza agrees to immediately notify Customer. Lonza also agrees that in the event that it becomes debarred, suspended, excluded, sanctioned, and/or otherwise declared ineligible, it shall immediately cease all activities relating to this Agreement; |
| 10.1.7 | title to all Product and all New Customer Intellectual Property provided to Customer under this Agreement shall pass free and clear of any security interest, lien and/or other encumbrance; and |
| 10.2.1 | Customer has and shall at all times throughout the Term of this Agreement have the right to supply the Cell Line, the Customer Materials and the Customer Information to Lonza and the necessary rights to license and/or permit Lonza to use the same for the sole purposes of performing the Services; |
| 10.2.2 | to the best of Customer’s knowledge and belief, the use of the Customer Information, Customer Background Intellectual Property or Customer Materials by Lonza in the course of performance of Services shall not infringe, misappropriate or violate (as the case may be) any Intellectual Property rights of any Third Party; |
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10.3 | DISCLAIMER: THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. |
10.4 | Debarment. |
| 10.4.2 | Lonza hereby certifies that it will not knowingly use in any capacity the services of any individual, corporation, partnership and/or association which has been debarred under 21 U.S.C. Sec. 335a(a) or (b), and/or listed in the DHHS/OIG List of Excluded Individuals/Entities and/or the General Services Administration’s Listing of Parties Excluded from Federal Procurement and Non-Procurement Programs. |
| 11.1.1 | any breach of this Agreement and/or the Quality Agreement by Lonza, including the warranties given by Lonza in Clause 10.1; |
| 11.1.3 | the gross negligence and/or intentionally wrongful acts and/or omissions of Lonza and/or any Lonza Indemnitee; and/or |
| 11.1.4 | any allegation that the Services (excluding solely as a result of use of Customer Information, Customer Background Intellectual Property and/or Customer Materials supplied by and/or on behalf of Customer) infringes, misappropriates and/or otherwise violates any Intellectual Property rights of a Third Party; |
except in each case to the extent that such claims resulted from the negligence, intentional misconduct and/or breach of this Agreement and/or the Quality Agreement by any Customer Indemnitees.
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Notwithstanding the foregoing, Lonza shall have no obligations under this Clause 11.1 for any liabilities, expenses, and/or costs to the extent arising out of and/or relating to claims covered under Clause 11.2.
| 11.2.1 | any breach of this Agreement and/or the Quality Agreement by Customer, including the warranties given by Customer in Clause 10.2 above; |
| 11.2.2 | any claims alleging that the use of the Customer Information, Customer Background Intellectual Property and/or Customer Materials in the course of performance of Services infringes any Intellectual Property rights of a Third Party; |
| 11.2.3 | the manufacture, use, sale, or distribution of the Product by or on behalf of Customer, including any claims of product liability; |
| 11.2.4 | the gross negligence and/or intentionally wrongful acts and/or omissions of Customer and/or any Customer Indemnitee; or |
| 11.2.5 | any allegation that the use by Lonza of any Customer Information, Customer Background Intellectual Property and/or Customer Materials supplied by and/or on behalf of Customer for the purpose of this Agreement (excluding solely as a result of use by and/or on behalf of Lonza of Lonza Background Intellectual Property, Lonza Information and/or other material and/or information supplied by Lonza) infringes, misappropriates and/or otherwise violates any Intellectual Property rights of a Third Party; |
except, in each case, to the extent that such claims resulted from the negligence, intentional misconduct and/or breach of this Agreement and/or the Quality Agreement by any Lonza Indemnitees.
Notwithstanding the foregoing, Customer shall have no obligations under this Clause 11.2 for any liabilities, expenses, and/or costs to the extent arising out of and/or relating to claims covered under Clause 11.1.
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11.6 | Additional Exceptions. Nothing in this Agreement shall exclude and/or limit the liability of either Party for fraud, breach its obligations in respect of Intellectual Property pursuant to Clause 9 and/or for death and/or personal injury caused by its negligence and/or for any other liability that may not be limited and/or excluded as a matter of law. |
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12.3 | Exceptions. The obligation to maintain confidentiality under this Agreement does not apply to Confidential Information, which: |
| 12.3.2 | is and/or becomes publicly available other than as a result of a breach of this Agreement by the Receiving Party; |
| 12.3.5 | is developed by the Receiving Party independently from and without use of the Confidential Information, as evidenced by contemporaneous written records. |
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set forth herein. The Receiving Party shall notify the Disclosing Party as promptly as practicable of any unauthorized use and/or disclosure of the Confidential Information. |
13.1 | Term. This Agreement shall commence on the Effective Date and, unless terminated earlier as provided herein, shall remain in full force until [Redacted] after the Effective Date (the “Term”). |
Without limiting the generality of Clause 13.2.2, Lonza shall be deemed to have breached a material provision of this Agreement if: [Redacted];
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| 13.3.1 | by Customer pursuant to Clause 13.2.2 (Material Breach), 13.2.3 (Insolvency),13.2.4 (Uncured Supply Failure), 13.2.5 (Debarment) or 13.2.6 (Force Majeure): |
| (a) | Lonza shall be compensated for Services and Batches rendered up to the date of termination, including in respect of any Product in-process; |
| 13.3.5 | and/or expiration hereunder, Lonza shall promptly return to Customer all remaining Raw Materials that Customer has paid for; and |
| 13.3.6 | notwithstanding Clause 6.5, any amounts payable by Customer pursuant to Clauses 13.3.1 or 13.3.2 shall be due [Redacted] of Customer’s receipt of an undisputed invoice therefor from Lonza. |
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(Indemnification), 12 (Confidentiality), 13.3 (Consequences of Termination), 13.4 (Survival), 15 (Notice) and 16 (Miscellaneous) (to the extent relevant). |
14.4 | Lonza Affiliates and Suppliers. With regard to Lonza, any such event of Force Majeure affecting services and/or production at its Affiliates and/or suppliers shall be regarded as an event of Force Majeure. |
15.1 | Notice Addresses. Any notice or other communication to be given under this Agreement shall be delivered personally and/or sent by email, or if email is not available, by first class pre-paid post addressed as follows: |
| 15.1.1 | [Redacted] |
| 15.1.2 | [Redacted] |
or to such other destination as either Party hereto may hereafter notify to the other in accordance with the provisions of this Clause 15. |
15.2 | Timing of Delivery. All such notices and/or other communications shall be deemed to have been served as follows: |
| 15.2.1 | if delivered personally, at the time of such delivery; |
| 15.2.3 | if sent by first class pre-paid post, four (4) business days (Saturdays, Sundays and bank and/or other public holidays excluded) after being placed in the post. |
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16.4 | Publicity. The text of any press release and/or other communication to be published by and/or in the media concerning the subject matter of this Agreement shall require the prior written approval of both Lonza and Customer. |
16.5 | Governing Law. This Agreement is governed in all respects by the laws of the State of New York without regard to its conflicts of laws principles. |
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federal courts located in the Borough of Manhattan, New York, New York, USA for purposes of determining the arbitrability of any Dispute, causing such Party to appear for and participate in such arbitration and enforcing any award granted by the arbitrators, and each Party hereby submits to such jurisdiction. Notwithstanding the foregoing, if Lonza commits a Willful Breach, Customer may, at its election, bring and maintain any claim against Lonza for such Willful Breach against Lonza in any court of competent jurisdiction. |
16.8 | Third Party Rights. The Parties to this Agreement do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to this Agreement. |
16.9 | Non-Exclusive Nature of Remedies. Unless otherwise expressly set forth in this Agreement, no remedies set forth herein shall be considered an exclusive remedy. Pursuit or receipt of any remedies by a Party for breach of this Agreement by the other Party does not constitute an election of remedies by such Party to the exclusion of other remedies potentially available. |
16.10 | Successors. Subject to the restrictions on transfer contained in this Agreement, this Agreement will enure to the benefit of and be binding on the Parties and their respective successors and permitted assigns. |
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IN WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to be executed by its duly authorized representative effective as of the date written above.
LONZA AG | |
By: |
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| Name Title |
By: |
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| Name Title |
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ALLAKOS, INC. | |
By: |
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| Name: Title: |
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