Document:

ex101

    1/5          Exhibit 10.1    [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED  BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.    NINTH AMENDMENT  TO DEVELOPMENT AND SUPPLY AGREEMENT    Effective as of the date of the last signature below, AbbVie Inc. (the successor-in-interest to Abbott Laboratories), a Delaware  corporation having a principal place of business at 1 N Waukegan Road, North Chicago, IL 60064 (“AbbVie”), and Seattle Genetics,  Inc., a Delaware corporation having a principal place of business at 21823 – 30th Drive Southeast in Bothell, Washington 98021  (“Seattle Genetics”) (individually the “Party” or collectively the “Parties”) agree to the following terms and conditions as set forth  below (this “Ninth Amendment”). Capitalized terms used but not defined herein shall have the meaning ascribed to them in the  Agreement (as defined below).    WHEREAS, the Parties entered into a Development and Supply Agreement with an Effective Date of February 23, 2004 for the  manufacture of a chimeric anti-CD30 AC10 monoclonal antibody known as cAC10 Bulk Drug Intermediate (the “Original  Agreement”), which also constitutes the antibody component of SGN-35, and the Parties subsequently entered into eight amendments  to the Original Agreement (collectively, the Original Agreement and those eight amendments are hereinafter referred to as the  “Agreement”);    WHEREAS, Abbott Laboratories (“Abbott”) and AbbVie entered into a Separation and Distribution Agreement dated as of  November 28, 2012 (the “Separation and Distribution Agreement”), which provided for, among other things, the separation of  Abbott’s research-based pharmaceuticals business from its other business by the contribution from Abbott to AbbVie of certain assets,  the assumption of AbbVie of certain Liabilities (as defined in the Separation and Distribution Agreement) from Abbott, the distribution  by Abbott of AbbVie common stock to Abbott shareholders, and the execution and delivery of certain agreements in order to facilitate  and provide for the foregoing, in each case subject to the terms and conditions set forth therein;    WHEREAS, in connection with the Separation and Distribution Agreement, Abbott assigned, transferred and conveyed all of its  rights and obligations under the Agreement to AbbVie and AbbVie accepted and assumed all rights and obligations of Abbott under the  Agreement as further set forth below; and    WHEREAS, the Parties desire to further amend the Agreement as herein provided as of the date of the last signature below.    NOW, THEREFORE, in consideration of the mutual covenants and agreements contained here and for other good and valuable  consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:  

 

    2/5      1. Incorporation of the Agreement. All capitalized terms which are used but not otherwise defined herein shall have the same  meanings as set forth in the Agreement, and the Agreement, to the extent not inconsistent with this Ninth Amendment, is incorporated  herein by this reference as though the same was set forth in its entirety. To the extent any terms and provisions of the Agreement are  inconsistent with this Ninth Amendment, such terms and provisions shall be deemed superseded by the Ninth Amendment. Except as  specifically set forth herein, the Agreement shall remain in full force and effect and its provisions shall be binding on the Parties.    2. Process Development Work. The Parties agree that AbbVie shall perform the Stage set forth in Attachment 1 hereto entitled  “Stage 14: Stability Testing” pursuant to the terms and conditions of the Agreement and this Ninth Amendment.    3. Payment Schedule. As compensation for the Stage to be performed by AbbVie pursuant to Attachment 1 hereto and the  remaining compensation due to AbbVie pursuant to Stage 13A that was the subject of the Seventh Amendment to Development and  Supply Agreement between the Parties, Seattle Genetics shall pay to AbbVie on the dates and in the amounts set forth in Attachment 2  hereto entitled “Updated Summarized Payment Schedule (Amendments 7 & 9)”.    4. Project References. All references to the Project set forth in the Agreement shall also be deemed to apply to the Stage  performed by AbbVie pursuant to this Ninth Amendment.    5. Effectuation. The amendment to the Agreement contemplated by this Ninth Amendment shall be deemed effective as of the last  date written below upon the full execution of this Ninth Amendment and without any further action required by the Parties hereto.  There are no conditions precedent or subsequent to the effectiveness of this Ninth Amendment. All terms and conditions set forth in the  Agreement that are not amended hereby shall remain in full force and effect. Any term of this Ninth Amendment may be amended with  the written consent of both Parties. From the date hereof, any reference to the Agreement shall be deemed to refer to the Agreement as  amended by this Ninth Amendment.    6. Counterparts. This Ninth Amendment may be executed in one or more counterparts, each of which shall be deemed to be an  original, but all of which together shall constitute one and the same instrument. One or more counterparts of this Ninth Amendment  may be delivered by facsimile, with the intention that delivery by such means shall have the same effect as delivery of an original  counterpart thereof.    7. Entire Agreement. This Ninth Amendment is the product of both Parties, and together with the Agreement and exhibits thereto,  constitute the entire agreement between the Parties pertaining to the subject matter hereof, and merge all prior negotiations and drafts  of the Parties with regard to the transactions contemplated herein.  2  [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the  Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.  

 

    3/5      IN WITNESS WHEREOF, the Parties have caused this Ninth Amendment to be executed by their duly authorized officers as of  the date of the last signature set forth below.    ABBVIE INC. SEATTLE GENETICS, INC.    By: /s/ Keith Kentala By: /s/ Vaughn B. Himes     Name: Keith Kentala Name: Vaughn B. Himes  Title: VP, Operations Commercial Development Title: EVP  Date:   8/28/2016 Date: 8/12/2016  3  

 

    4/5      Attachment 1    STAGE 14: STABILITY TESTING    [*]  4  [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the  Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.  

 

    5/5      Attachment 2    UPDATED SUMMARIZED PAYMENT SCHEDULE (Amendments 7 & 9)    [*]  5  [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the  Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.ex102

  [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.  Exhibit 10.2    COMMERCIAL SUPPLY AGREEMENT    Between  SEAGEN INC.  and    HOVIONE FARMACIENCIA, SA    THIS COMMERCIAL SUPPLY AGREEMENT (“Agreement”) is made and entered into as of the 1st  day of July, 2021 (“Effective Date”) between Seagen Inc., 21823 SE 30th Drive, Bothell, WA 98021  USA (“Customer”), and Hovione FarmaCiencia SA, Sete Casas, 2670 Loures, Portugal (“Hovione”).    WHEREAS, Customer is in the business of manufacturing, packaging, marketing and  selling certain pharmaceutical products, including without limitation, the Product (as defined  below);    WHEREAS, Hovione provides development, manufacturing, analytical and/or other  related services to the pharmaceutical industry and has the requisite expertise, personnel and  facilities to enable Hovione to perform certain of such services in connection with the Product  under this Agreement; and    WHEREAS, Customer desires to have Hovione manufacture for, and supply certain  quantities of Product to, Customer in accordance with the terms and conditions of this Agreement.    NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and  promises set forth herein, the Parties hereby agree as follows:    1. Definitions. For the purposes of this Agreement, unless this Agreement expressly provides  otherwise or unless the context otherwise requires, the following initially capitalized terms, whether  used in the singular or plural, will have the respective meanings set forth below:    1.1 “Affiliate” means, with respect to a Party, any corporation, company, partnership, joint  venture and/or firm that controls, is controlled by or is under common control with such  Party. As used in this Agreement, “control” means (a) in the case of a corporate entity,  direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the  right to vote for the election of directors, and (b) in the case of a non-corporate entity, the  direct or indirect power to manage, direct or cause the direction of the management and  policies of the non-corporate entity or the power to elect at least fifty percent (50%) of the  members of the governing body of such non-corporate entity.    1.2 “API” means the Customer’s proprietary active pharmaceutical ingredient known as  Tucatinib Drug Substance [*].    1.3 “Applicable Law” means all laws, rules, regulations, guidelines, or other requirements of  any Authority that may be in effect from time to time and that are applicable to Manufacturing  Services in the Territory , including but not limited to, those relating to anti-bribery or  anticorruption, and:    (a) the 1997 OECD Convention on Combating Bribery of Foreign Public Officials in  International Business Transactions;  

 

Page 2          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.     (b) the International Conference on Harmonisation (ICH) Guidelines, Good Manufacturing  Practice Guidance for Active Pharmaceutical Ingredients; and    (c) cGMP, including without limitation, cGMP as described in the PIC/S GMP guides; Parts  210 and 211 of Title 21 of the United States Code of Federal Regulations and all applicable  rules, regulations, orders and guidance published thereunder; European Commission  Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC and the  current Good Manufacturing Practices guidance published by the European Commission  in the “Guide to good manufacturing practice for medicinal products”(“The rules  governing medicinal products for human use”, IV Volume and the relevant annexes), as  specified by the competent authorities; and any other applicable local regulation; together  with the other latest FDA, EMA, PMDA and ICH guidance documents pertaining to  manufacturing and quality control practice, all as updated, amended and revised from time  to time, including all requirements applicable to the qualification and validation of the  Facility, equipment and processes.    1.4 “Authority” means any government regulatory authority responsible (a) for granting  approvals for the performance of Services under this Agreement, or (b) for issuing  regulations pertaining to the Manufacture or use of the Product in the Territory.    1.5 “Binding Forecast” has the meaning set forth in Section 5.1.    1.6 “Business Day” means any day except Saturday or Sunday in which banks are open for  business in the United States.    1.7 “Certificate of Analysis” means a document signed by an authorized representative of  Hovione describing the testing methods applied to the Product, and the results of such  testing.    1.8 “Certificate of Compliance” means a document signed by an authorized representative of  Hovione certifying that a particular batch of Product was manufactured in accordance with  cGMP, Applicable Law to such Manufacturing and the Specifications.    1.9 “cGMP” means current good manufacturing practices regulations applicable to the  Manufacture of the Product, as defined by the Q7 Guidance on Good Manufacturing  Practices of the International Conference on Harmonization of Technical Requirements of  Pharmaceuticals for Human Use (ICH Q7) and as promulgated by any Authority.    1.10 “Confidential Information” has the meaning set forth in Section 11.1.    1.11 “Contract Year” means the twelve (12) month period commencing on the Effective Date  and ending on the day before the first anniversary thereof and each consecutive twelve (12)  month period thereafter during the Term.    1.12 “Customer Indemnitee” has the meaning set forth in Section 13.1.    1.13 “Customer Improvements” means all [*].    1.14 “Customer Materials” means the materials, if any, identified by the Parties in writing as  

 

Page 3          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   being provided by Customer hereunder, including the API.    1.15 “Customer Technology” means the Technology of Customer [*].    1.16 “EMA” means the European Medicines Agency, or any successor agency having  substantially the same functions.    1.17  “Facility” means Hovione’s manufacturing facility located at [*].    1.18 “FDA” means the United States Food and Drug Administration, or any successor agency  having substantially the same functions.    1.19 “Forecast” has the meaning set forth in Section 5.1.    1.20 “Hovione Improvements” means all [*].    1.21 “Hovione Indemnitees” has the meaning set forth in Section 13.2.    1.22 “Hovione Technology” means the Technology [*].    1.23 “Improvements” means all discoveries, inventions, developments, modifications,  innovations, updates, enhancements or improvements to Technology (whether or not  protectable under patent, trademark, copyright or similar laws) that are conceived,  discovered, invented, developed, created, made or reduced to practice in the performance  of the Parties’ obligations under this Agreement.    1.24 “Inspection Period” has the meaning set forth in Section 5.5(a).    1.25 “Launch Date” means the date of first commercial sale of the Product.    1.26 “Latent Defect” means a failure of the Product to [*] that (a) couldn’t reasonably have been  identified [*], and (b) [*]. “Latent Defect” does not include any such failure [*]. For the  avoidance of doubt, if any Product has [*].    1.27 “Losses” has the meaning set forth in Section 13.1.    1.28 “Manufacture”, “Manufactured” and “Manufacturing” means any steps, processes or  activities used or undertaken by Hovione to manufacture and supply the Product to  Customer hereunder.    1.29 “Minimum Annual Purchase Commitment” has the meaning set forth in Section 2.1.    1.30 “Non-binding Forecast” has the meaning set forth in Section 5.1.    1.31 “Parties” means Customer and Hovione together.    1.32 “Party” means either Customer or Hovione, as the context requires.    1.33 “Partner” means a Third Party working with or on behalf of Customer in relation to the  Product, including without limitation Customer’s licensees, sublicensees and other  

 

Page 4          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   collaboration partners and suppliers, provided that such Third Party is not a bona fide  competitor of Hovione predominantly engaged in business as a contract manufacturing  organization that materially competes with Hovione. For avoidance of doubt, a  pharmaceutical company is not a contract manufacturing organization.    1.34 “Person” means an individual natural person, sole proprietorship, partnership, limited  partnership, limited liability partnership, corporation, limited liability company, business  trust, joint stock company, trust, incorporated association, joint venture or similar entity or  organization, including a government or political subdivision, department or agency of a  government.    1.35 “PMDA” means the Pharmaceuticals and Medical Devices Agency of Japan, or any  successor agency having substantially the same functions.    1.36 “PPI” has the meaning set forth in Exhibit D.    1.37 “Product” means Tucatinib spray-dried dispersion or drug product intermediate.    1.38 “Purchase Price” has the meaning set forth in Section 6.1.    1.39 “Quality Agreement” means a separate agreement which applies to Services to be  performed under cGMP requirements, signed by each of the Parties and setting forth the  mutual responsibilities of the Parties with respect to quality assurance and cGMP  guidelines applicable to Services performed by Hovione. Such responsibilities of Hovione  and Customer are set forth in the Quality Agreement.    1.40 “Recalls” has the meaning set forth in Section 5.8.    1.41 “Records” has the meaning set forth in Section 4.1.    1.42 “Representative” has the meaning set forth in Section 2.2.    1.43 “Services” means Manufacturing, processing, quality control testing, release and/or  storage of the Product by Hovione pursuant to and in accordance with the terms of this  Agreement.    1.44 “Specifications” means the specifications, quality standards, Certificate of Compliance,  Certificate of Analysis, including analytical testing data, if any, the master batch record, all  formulas, standards, requirements, quality assurance standards, processes, and all  modifications or improvements of such master batch record, formulas, standards,  requirements, quality assurance standards, applicable analytical test methodologies,  processes and specifications, for such Product(s), that are attached hereto as Exhibit A, or  that are otherwise mutually agreed to by the Parties in writing.    1.45 “Technology” means all methods, techniques, trade secrets, copyrights, know-how, data,  documentation, hardware, software and other intellectual property of any kind, whether or  not protectable under patent, trademark, copyright or similar laws.    1.46 “Term” has the meaning set forth in Section 9.1.    

 

Page 5          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   1.47 “Territory” means [*] and any other jurisdiction as may be agreed by the Parties in writing.    1.48 “Third Party” means any Person, including, without limitation, a Partner, other than the  Parties and their respective Affiliates.    2. The Services.    2.1 Exclusive Supply and Purchase of Product. During the Term and subject to the terms and  conditions set forth herein, Hovione shall Manufacture Product [*], and Customer shall  purchase Product non-exclusively from Hovione. Hovione shall Manufacture for Customer  and Customer shall purchase:    (a) At least [*] of their respective commercial requirements of Product [*]; and    (b) [*];    subject, in the case of both (a) and (b), to the minimum annual purchase commitment for  the Product set forth in Exhibit B attached hereto (the “Minimum Annual Purchase  Commitment”). Notwithstanding the foregoing, Customer shall not be precluded from  taking any and all commercially reasonable steps to qualify alternative suppliers for  Product prior to the expiration or termination of this Agreement in the event of a supply  interruption, nor from obtaining alternative suppliers for any amount of Product that  Hovione is unable or unwilling to Manufacture in accordance with the terms and conditions  of this Agreement.    2.2 Communications. Each Party will appoint a project representative (each, a  “Representative”) who will have primary responsibility for day-to-day interactions with  the other Party’s Representative concerning the Services. Either Party may appoint a  substitute or successor Representative by providing written notice thereof to the other  Party.    2.3 Subcontracting. Upon the prior written agreement of Customer, Hovione may subcontract  the performance of certain of its obligations under this Agreement to its Affiliates or to  qualified Third Parties, provided that such Affiliates or Third Parties will perform the  activities in a manner consistent with this Agreement and will be obligated, in writing, to  protect the confidentiality of Confidential Information under terms no less stringent than  those set forth in Section 11. Hovione will remain liable for the actions or inactions of any  Third Party with whom it contracts for any such obligations under this Agreement.    2.4 Quality Agreement. Within [*] after the execution of this Agreement and prior to Hovione  conducting any Services hereunder that are subject to cGMP requirements, the Parties will  enter into the Quality Agreement, to establish the Parties’ respective quality assurance  responsibilities relating to the Services. Upon its execution, the Quality Agreement shall  be incorporated by reference into this Agreement. In the event of a conflict between the  terms of the Quality Agreement and this Agreement, the terms of the Quality Agreement  will govern with respect to all quality assurance matters and the terms of this Agreement  will govern with respect to all other matters.    2.5 Validation. Hovione shall perform all validation of the Facility, equipment and processes  employed in the manufacturing process in accordance with cGMP, Applicable Law, the  

 

Page 6          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Quality Agreement and Hovione’s standard operating procedures, and in accordance with  any other validation procedures requested by Customer and approved to in writing by  Hovione.    2.6 Hovione’s Data Models. Customer acknowledges and agrees that Hovione’s operation  benefits from the use of anonymized raw data arising from the provision of Manufacturing  Services, thereby continuously improving various aspects of services to the benefit of the  customers. Therefore, notwithstanding anything in this Agreement to the contrary, Hovione  is hereby expressly authorized to use such data for the sole purposes of data modeling and  performing anonymized regression analysis with such data in order to generate  mathematical and statistical models to improve Hovione services in the future.    3. Materials.    3.1 Customer Materials. Customer will supply the Customer Materials, including delivering  the API to Hovione, at Customer’s cost and expense. Starting [*] after Effective Date and  thereafter during the Term, Customer shall exercise commercially reasonable efforts to  provide to Hovione a safety stock of API equal to at least [*] of Customer’s anticipated  requirements of Product. Hovione will store Customer Materials and Product up to [*]. For  longer periods Hovione will charge a storage fee at [*].    3.2 Hovione-Supplied Materials. Unless the Parties otherwise agree in writing, Hovione will  supply, at Customer’s expense and in accordance with all relevant approved raw material  specifications, all materials to be used by Hovione in the performance of Services, other  than the Customer Materials and Customer Technology. Title to and risk of loss for [*].  All such Hovione-supplied materials supplied by Hovione at Customer’s expense shall be  used exclusively in the performance of Services hereunder.    3.3 Title to and Risk of Loss of the Customer Materials and Customer Technology.    (a) Title. Title to Customer Materials and Customer Technology supplied by Customer  will at all times remain with Customer. Hovione will acquire no right, title or  interest in or to such Customer Materials or Customer Technology, nor will it take  or suffer any action inconsistent with Customer’s ownership or interest in the  Customer Materials or Customer Technology, including but not limited to the  imposition of any lien thereon, the conveyance of any interest therein, or any use  thereof except as authorized by the terms of this Agreement.    (b) Risk of Loss of the Customer Materials. Risk of loss of the Customers Materials  will [*]:    (i) Hovione will use commercially reasonable efforts to keep secure and  account for all Customer Materials and provide Customer with access to  inventory information through [*]; and    (ii) Hovione agrees to reimburse Customer[*], for any quantities of Customer  Materials lost or destroyed while in the custody of Hovione to the extent  [*]. Notwithstanding anything to the contrary in this Agreement, [*].    

 

Page 7          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   (c) Return. Promptly upon the earlier of the completion of the Services or the  expiration or termination of this Agreement, including as may be earlier required  under Section 9.3(a), all unused Customer Materials and Customer Technology  will be returned to Customer, or otherwise disposed of or destroyed in accordance  with written instructions from Customer, in each case at Customer’s expense.    3.4 Target Yield and Yield Banking System    (a) Based on the data of the first [*] commercial batches of Product Manufactured in  accordance with this Agreement, Parties will agree in good faith the applicable  target yield of Manufacture of Product per kilogram of Customer Materials (the  “Target Yield”). An actual yield below the Target Yield will be considered a loss,  an actual yield above the Target Yield will be considered a gain.    (b) Hovione and Customer agree on a yield banking system for Manufacture of  Product, effective as of the Effective Date, to properly reflect any gains or losses  relative to the Target Yield cumulative over at least [*] batches of Product  Manufactured by Hovione. The gains of Customer Materials used in the  Manufacture of Product shall be reviewed within [*] after the completion of each  set of [*] batches and shall be calculated in accordance with the following formula:    [*]    If after a set of [*] batches Hovione has achieved gains or losses in Customer  Materials, calculated in accordance with the preceding paragraph, such gains or  losses shall be added to the yield banking system.    (c) In the event of Hovione’s liability for loss or destruction of Customer Materials, in  accordance with Section 3.3(b), Hovione may [*]. For the avoidance of doubt,  subject to Section 3.3(b), Hovione shall [*].    4. Records; Personnel and Inspection.    4.1 Records. Hovione will keep complete and accurate records in the course of its performance  of the Services (the “Records”). While in the possession or control of Hovione, Records  will be provided to support approvals, batch review and disposition, inspection,  examination and copying by or on behalf of Customer and at Customer’s expense;  provided, however, that Hovione may exclude or redact from such Records any confidential  or proprietary information of Third Parties or any Hovione Technology that Hovione  regards as trade secrets. Upon termination of this Agreement, Hovione will transfer to  Customer, at Customer’s expense, the Records; provided, however, that Hovione may (a)  retain one copy of such Records solely for the purposes of internal record-keeping, and  monitoring its obligations under this Agreement and as required by Applicable Law,  provided Hovione’s confidentiality obligations set forth herein shall continue to apply to  such Records pursuant to the terms of Section 11, and (b) exclude or redact from such  Records any confidential or proprietary information of Third Parties.    4.2 Inspections, Visits, and Audits.    

 

Page 8          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   (a) Audit. Customer’s or its Partner’s duly designated representatives (that are  reasonably acceptable to Hovione) will have the right, upon at least [*] prior written  notice, and not more than [*] unless for cause, to have up to [*], or more if agreed  to by Hovione, Customer employees or Partner employees or representatives who  are subject to confidentiality obligations to Customer or Hovione no less restrictive  than those set forth in this Agreement, access during operational hours to audit the  Facility and Records to ascertain compliance by Hovione with the terms of this  Agreement, the Quality Agreement, and the Specifications in the performance of  the Services or Manufacturing. Each such audit that is not longer than [*] in  duration will be at no charge to Customer or Partner. Additional audits, and audit  days without cause, will be at Customer’s expense based on Hovione’s standard  fees unless otherwise agreed to by Hovione.    (b) Visit. Customer or its Partner or other duly designated representative (that is  reasonably acceptable to Hovione) will have the right, upon at least [*] written  notice without cause, and upon any shorter notice Hovione will use Commercially  Reasonable Efforts to accommodate such request, to have [*] Customer employees  or Partner employees or representatives, during normal business hours, at  Customer’s cost, (i) observe the Manufacturing of Product at the site; (ii) review the  Records; and (iii) inspect the Facility during the performance of the Services.    (c) Customer employees and/or Partner employees or representatives who inspect,  visit, or audit Hovione’s Facility and Records will do so during normal business  hours and at all times comply with Hovione’s rules, regulations and SOPs relating  to inspections and visits to the Facility, and Customer retains full responsibility  and liability for the presence and actions of its employees on Hovione’s premises.  Any Partner or any employees or representatives of Customer and/or Partner  conducting any inspection, visit or audit pursuant to the terms of this Section 4.2  shall be subject to confidentiality obligations no less restrictive than those set forth  in this Agreement.    5. Forecasts; Purchase Orders; Shipping and Delivery; Acceptance.    5.1 Forecasts. Commencing upon execution of this Agreement, and on a quarterly basis  thereafter until the expiration or termination of this Agreement, Customer will provide a  rolling [*] forecast of its commercial requirements for Product (the “Forecast”). The first  [*] of each Forecast, once approved in writing by Hovione, will be binding on the Parties  and shall contain commitments from Customer for quarterly deliveries of Product within  such [*] period (the “Binding Forecast”) and the following [*] will be non-binding, good  faith estimates (the “Non- binding Forecast”).    Upon acceptance from Hovione of any purchase orders in relation to the Binding Forecast,  in accordance with Section 5.2 below, Hovione shall notify Customer, within [*] from date  of submission by Customer of such purchase order, of the planned Manufacturing schedule  for such purchase order and the Binding Forecast shall be deemed to include such planned  schedule for Manufacturing. Commencing at the end of calendar year 2021, if delays or  shortfalls in performance of the Services are experienced due to Customer’s sole fault or  otherwise because of Customer’s failure to supply Hovione with Customer Materials [*],  

 

Page 9          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   unless agreed otherwise, then Hovione may [*]. If Customer cures any such shortfall  and/or delivers Customer Materials thereafter and [*], then [*]. If Customer cures any such  shortfall and/or delivers Customer Materials thereafter and, [*], then [*].    5.2 Purchase Orders. Together with each Forecast, Customer will submit firm, non-cancelable  purchase orders for Product under the applicable Binding Forecast. All purchase orders for  Product shall state the quantities of Product to be purchased, the requested delivery dates,  and shipping instructions. Purchase orders for Product shall state the ordered quantity in  increments of full batches of Product. Each purchase order will be confirmatory of, and  supplemental to, the Binding Forecast rather than creating a new legal obligation. For  clarity, each purchase order placed by Customer will be deemed as accepted by Hovione  to the extent that it is consistent with the Binding Forecast. Hovione may, in writing, object  within [*] after submission by Customer of any purchase order that such purchase order is  inconsistent with the Binding Forecast if such purchase order contains a more than [*]  variance from the most recently submitted Binding Forecast. If the quantity of Product  ordered under a purchase order exceeds [*] of the most recently submitted Binding  Forecast, Hovione will use commercially reasonable efforts to supply the excess quantity  of Product ordered by Customer. Hovione shall deliver the Product according to the  accepted purchase order. If Hovione determines it will be unable to meet the requirements  of an accepted purchase order, Hovione shall provide Customer with as much advance  notice as possible and Customer at is sole discretion may require Hovione to [*].    5.3 Shortfalls or Delays. Repeated shortfalls or delays in the performance of Services [*].  “Repeated” as used herein shall mean [*]; “Shortfall” as used herein shall mean [*] and  “Delay” as used herein shall mean [*]. For the avoidance of doubt Defects shall not be  considered as shortfalls for the purposes of this Section.    5.4 Shipping; Storage. Delivery terms are [*] the Facility (Incoterms 2020). Title to Product  and risk of loss or damage shall pass to Customer [*]. All shipping instructions of Customer  will be accompanied by the name and address of the recipient and the shipping date and  any costs and insurance associated with shipping will be borne by Customer. Should  Customer require special handling, packaging or other services, then the cost of such special  handling, packaging or other services will be borne entirely by Customer at Hovione’s  prevailing rates. On Customer’s written request, and at Customer’s cost and expense,  Hovione will store Product for up to an additional [*] following an initial grace period of  [*], which shall be free of charge following the release of the Product by Customer at the  Facility. Such additional storage beyond such [*] period will be subject to Hovione’s then  prevailing standard storage fees.    5.5 Inspection and Rejection.    (a) Inspection. Hovione will ship all Products in accordance with Section 5.4 upon  successful completion of any Product release testing required to be done by  Hovione, if any. Customer will have [*] from delivery (the “Inspection Period”) to  inspect and test the Product in accordance with Customer’s standard operating  procedures and using the testing methods identified in the Specifications. Prior to  the expiration of the Inspection Period for a shipment of Product, Customer will  provide prompt written notice to Hovione if any such Product does not comply with  [*]. Such notice will specify the nature of the Product’s non-compliance. Subject  to Section 5.5(b), failure by Customer to provide such notice within the applicable  

 

Page 10          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Inspection Period will be deemed an acceptance of such Product by Customer.    (b) Latent Defect. Customer may, [*], reject Product if it discovers that such Product  has a Latent Defect. Customer must notify Hovione of such Latent Defect as soon  as reasonably practicable and in writing, but in no case later than [*] after becoming  aware of the Latent Defect. Such notice will state in a reasonably sufficient detail  the reason for the Latent Defect.    5.6 Referee Laboratory. In case of any disagreement between the Parties as to whether Product  conforms to the applicable Specifications, a representative sample of such Product will be  submitted to an independent testing laboratory mutually agreed upon by the Parties  (“Referee Lab”) for tests and final determination of whether such Product conforms to such  Specifications. The Referee Lab must meet the requirements of cGMP, and be of recognized  standing in the industry, and consent to the appointment of such laboratory will not be  unreasonably withheld, conditioned or delayed by either Party. The Referee Lab will use the  test methods contained in the applicable Specifications. The determination of conformance  by the Referee Lab with respect to all or part of such Product will be final and binding on the  Parties. The fees and expenses of the Referee Lab incurred in making such determination  will be paid by the Party against whom the determination is made.    5.7 Remedies. If Hovione agrees or the Referee Lab determines that Product does not conform  to the applicable Specifications [*], then Customer will have the right to [*]. Customer will  [*]. Hovione will [*]. Hovione will [*]. If the Parties, through their Quality Assurance  groups, agree in writing, [*]. The [*] in this Section 5.7 [*].    5.8 Recalls.  The handling of field alerts, recalls and market withdrawals (collectively,  “Recalls”) of all Product will be within the sole discretion of Customer and Customer will  notify Hovione promptly of any Recall of Product. Notification to any Authority and the  conduct of such Recall will be the sole responsibility of Customer. Hovione will (a)  cooperate fully with Customer in the event of any such Recall and (b) provide such  assistance in connection with the Recall as Customer may reasonably request. Customer  will bear all expenses of any Recall and Hovione’s assistance unless and to the extent [*].  In all events, [*].    6. Price and Payments.    6.1 Price. Customer will pay Hovione the Purchase Price for the Product as set forth in Exhibit  D attached hereto. For Product intended for use outside of the Territory, the parties shall  review any additional regulatory requirements, other than any such regulatory requirements  imposed by [*], that may be imposed on Hovione in order to comply with Applicable Law  and agree in good faith to [*]. Hovione may not unreasonably delay or withhold an  agreement to modify the Territory and Customer may not unreasonably withhold payment  of reasonable cost of regulatory compliance as set forth herein.    6.2 Payments. Hovione will invoice Customer upon [*]. Payment of undisputed invoices will  be due [*] after the date of issuance of the applicable invoice; provided, however, that  invoices for deposits or other up-front fees will be paid by Customer within [*] after the date  Customer receives the applicable invoice. In the event any undisputed payment is not made  on time, Hovione will be entitled, in addition to its other rights and remedies hereunder, to  interrupt supply of Product until payment of such amounts or charge interest that shall accrue  

 

Page 11          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   on a daily basis and be calculated on the assumption of a 360-day year and using an annual  rate equal to [*]. Interest shall not be compounded.    6.3 Invoices. All payments hereunder will be made in [*]. Customer will make all payments  pursuant to this Agreement by wire transfer to a bank account designated in writing by  Hovione.    6.4 Taxes. Any use, sales, excise or value added tax, duty, custom, inspection or testing fee, or  any other tax, fee or charge of any nature whatsoever imposed by any governmental  authority on or measured by the transaction between Hovione and Customer (other than  Hovione’s income tax), will be paid by Customer in addition to the prices quoted or  invoiced by Hovione. In the event Hovione is required to pay any such tax, fee, or charge,  Customer will reimburse Hovione for such payment, or in lieu of such payment, Customer  will provide Hovione at the time the order is submitted an exemption certificate or other  document acceptable to the authority imposing the tax, fee or charge.    6.5 Import and Export. Without limiting the generality of Section 3.3(a), and in addition to any  other amounts due to Hovione under this Agreement, Customer will be responsible for all  costs or liabilities incurred by Hovione in connection with the import or export of Customer  Materials or Customer Technology, including but not limited to, the costs of any bank or  other guaranties required of Hovione by customs authorities, any penalties or fines levied  against Hovione that are related to such import or export, and any costs incurred by Hovione  in connection with any claims or proceedings relating to any of the foregoing.    7. Representations and Warranties.    7.1 By Both Parties. Hovione and Customer each represents and warrants to the other that:    (a) It is, and will remain, a corporation duly organized, validly existing and in good  standing under the laws of its jurisdiction of incorporation or organization.    (b) The execution and delivery of this Agreement has been authorized by all requisite  corporate action. This Agreement is and will remain a valid and binding obligation  of the executing Party, enforceable in accordance with its terms, subject to laws of  general application relating to bankruptcy, insolvency and the relief of debtors.    (c) It is under no contractual or other obligation or restriction that is inconsistent with  its execution or performance of this Agreement.    (d) It will comply with all Applicable Law related to the performance of its obligations  under this Agreement.    7.2 By Hovione. Hovione further represents and warrants to Customer that:    (a) The Services will be performed diligently, in a good and workmanlike manner, and  in accordance with all Applicable Laws and cGMP, and, upon delivery, the Product  will comply with the Specifications.    (b) To the best of Hovione’s knowledge, the use of Hovione Technology in the  performance of the Services will not infringe the intellectual property rights of any  

 

Page 12          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Third Party and Hovione will promptly notify Customer in writing should it  become aware of any claims asserting such infringement.    (c) Neither Hovione nor any of its employees providing the Services has been  debarred, or convicted, or is subject to a pending debarment or conviction, pursuant  to section 306 of the United States Food, Drug, and Cosmetic Act, 21 U.S.C.  § 335a.    (d) Hovione possesses all appropriate registrations, licenses and other governmental  authorizations required to perform the Services and to otherwise carry out its  obligations under this Agreement.    7.3 By Customer. Customer further represents and warrants to Hovione that:    (a) To the best of Customer’s knowledge, the use of Customer Technology as  contemplated in the Services will not infringe the intellectual property rights of  any Third Party and Customer will promptly notify Hovione in writing should it  become aware of any claims asserting such infringement.    (b) Upon delivery to Hovione, the API will comply with all Applicable Laws, the  specifications for the API, will have been manufactured in accordance with cGMP  and shall have been provided in accordance with the terms and conditions of this  Agreement, including, without limitation, the requirements of Section 8.2.    (c) Customer will comply with all applicable regulations pertaining to its use of the  Product in the Territory, as issued by any Authorities, in its use of the Product.    7.4 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,  NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY  WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT  NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A  PARTICULAR PURPOSE OR NON-INFRINGEMENT.    8. Government Approvals and Hazardous Materials.    8.1 Approvals. Hovione will be responsible for obtaining from any [*], at its expense, such  approvals related to the Facility as may be necessary for the performance of Services by  Hovione. Customer will be responsible for obtaining, at its expense, all regulatory and  governmental approvals and permits necessary for Customer to use the Product provided  under this Agreement, including without limitation, all submissions filed with the [*] or  other Authorities.    Customer may request modifications to the Facility that directly relate to the Manufacture  of Product in order to comply with Applicable Laws. If the change is unique to Customer  or is linked predominantly to Customer, the reasonable cost of the modification will be  borne by Customer. If [*] to implement the modification as defined in this Section 8.1,  Customer may terminate this Agreement on [*] prior notice.    8.2 Hazardous Materials. Prior to Hovione commencing the Services, Customer will inform  Hovione of all characteristics, including all health and safety characteristics, of the  

 

Page 13          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Customer Materials and when appropriate, provide Hovione with a Material Data Safety  Sheet on Customer Materials. Customer will immediately notify Hovione of any new  hazards or potential hazards to the health and safety of Hovione personnel relating to the  Customer Materials. If any resultant handling procedures have an incremental cost, such  cost will be borne by Customer.    9. Expiration and Termination.    9.1 Expiration. This Agreement will be effective as of the Effective Date. Unless earlier  terminated in accordance with this Section 9, this Agreement will remain in effect and  continue for an initial five (5) year term (the “Initial Term”), followed by successive two  (2)-year automatic renewals (each, a “Renewal Term” and together with the Initial Term,  the “Term”). Either Party may terminate this Agreement upon written notice to the other  Party at least [*] prior to commencement of the applicable Renewal Term.  9.2 Termination for Breach, Force Majeure or Bankruptcy. Either Party will have the right to  terminate this Agreement by written notice to the other Party upon the occurrence of any  of the following events: (a) if the other Party commits a breach of this Agreement which is  not remedied within [*] after the receipt by the breaching Party of written notice identifying  the breach and requiring its remedy; or (b) upon the occurrence of a force majeure event  preventing the other Party from performing its obligations under this Agreement as  provided in Section 10 for [*] or more; or (c) if the other Party ceases for any reason to  carry on business, or becomes bankrupt or insolvent, makes an assignment for the benefit  of its creditors or has a receiver or manager appointed in respect of all or any part of its assets  (which appointment is not vacated within [*] after filing) or is the subject of any proposal  for a voluntary arrangement or enters into liquidation.    9.3 Obligations on Termination.    (a) Of Hovione. Upon termination of this Agreement pursuant to this Section 9,  Hovione will suspend work as early as possible and:    (i) perform only those Services and other activities mutually agreed upon by  Customer and Hovione as being necessary or advisable to wind-down this  Agreement;    (ii) use commercially reasonable efforts to cancel any Third Party obligations;    (iii) promptly deliver to Customer all materials ordered by Hovione for  Customer after receipt of payment in full for such materials by Customer;    (iv) promptly return to Customer all unused and unopened Customer  Materials; and    (v) promptly return all Confidential Information of Customer that it has  received pursuant to this Agreement.    (b) Of Customer. Upon termination of this Agreement pursuant to this Section 9,  Customer will:    (i) promptly pay Hovione any undisputed monies due and owing Hovione  

 

Page 14          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   under this Agreement, up to the time of termination, for Services actually  performed, all authorized expenses actually incurred and, except for any  termination by Customer under Section 9.3(a), non-cancellable  commitments made by Hovione in connection with the Services; and    (ii) promptly return all Confidential Information of Hovione that it has  received pursuant to this Agreement.    9.4 Surviving Terms. Expiration or termination of this Agreement for any reason will not affect  any rights or obligation of either Party that accrued prior to such expiration or termination.  Further, the rights and obligations of the Parties under the following provisions of this  Agreement will survive in accordance with their terms: Sections 1, 5.7, 5.8, 6.2, 6.4, 6.5,  7, 8, 9.3, 9.4, 9.5 and 10 through 14.  9.5 Technology Transfer. Upon Customer’s request, Hovione will reasonably assist Customer,  and Customer shall compensate Hovione for such assistance, with the transfer of the  manufacturing process associated with the Product to Customer or its designee, provided  such transfer is made in accordance with Sections 11 and 12 of this Agreement. Parties  shall negotiate in good faith the commercial terms of any such technology transfer.    10. Force Majeure. Except as otherwise expressly set forth in this Agreement, and except for the  obligation to pay any amounts due under this Agreement, neither Party will have breached this  Agreement for failure or delay in fulfilling or performing any provision of this Agreement to the  extent such failure or delay is caused by or results from unforeseeable causes beyond the reasonable  control of the affected Party, including without limitation, fire, floods, embargoes, shortages,  epidemics, quarantines, war, acts of war (whether declared or not), insurrections, riots, acts of  terrorism, civil commotion, strikes, acts of God or acts, omissions or delays in acting, by any  Authority (“force majeure”). The Party affected by any event of force majeure will promptly notify  the other Party in writing, explaining the nature, details and expected duration of such force  majeure. Such Party will also notify the other Party from time to time as to when the affected Party  reasonably expects to resume performance in whole or in part of its obligations hereunder, and to  notify the other Party of the cessation of any such event. A Party affected by an event of force  majeure will use commercially reasonable efforts to remedy, remove or mitigate such event and  the effects thereof with all reasonable dispatch. Upon termination of the event of force majeure, the  performance of any suspended obligation or duty will promptly recommence.    11. Confidentiality.    11.1 Definition. “Confidential Information” means any and all non-public scientific,  technical, financial or business information in whatever form (written, oral or visual) that  is furnished or made available by or on behalf of one Party (“Disclosing Party”) to the  other Party (“Receiving Party”), regardless of whether such information is marked  “confidential” or not. Confidential Information of Hovione includes, but is not limited to,  Hovione Technology and Hovione Improvements, whether or not labeled confidential.  Confidential Information of Customer includes, but is not limited to, Customer Technology  and Customer Improvements, whether or not labeled confidential. The terms of this  Agreement are the Confidential Information of both Parties.    11.2 Obligations. The Receiving Party agrees (a) to keep confidential the Confidential  Information of the Disclosing Party and the terms of this Agreement, (b) not to disclose the  

 

Page 15          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Disclosing Party’s Confidential Information to any Third Party without the prior written  consent of the Disclosing Party, and (c) to use such Confidential Information only as  necessary to fulfill its obligations or in the reasonable exercise of rights granted to it  hereunder. A Receiving Party, however, may disclose (i) Confidential Information of the  Disclosing Party to its employees, consultants and other representatives and to those of its  Affiliates, in each case who have a specific need to know such Confidential Information  and who are bound by an obligation of confidentiality and restriction on use at least as  stringent as the obligation of confidentiality and restriction on use as set forth in this  Agreement. With respect to [*], in each case not to be unreasonably withheld [*].     11.3 Exceptions.    (a) The Receiving Party’s obligations of non-disclosure and non-use under this  Section 11 will not apply to any portion of the Disclosing Party’s Confidential  Information that the Receiving Party can demonstrate, by competent written proof:    (i) is generally known to the public at the time of disclosure or becomes  generally known through no wrongful act on the part of the Receiving  Party;    (ii) is in the Receiving Party’s possession at the time of disclosure other than  as a result of the Receiving Party’s breach of any legal obligation;    (iii) becomes known to the Receiving Party on a non-confidential basis through  disclosure by sources (other than the Disclosing Party) having the legal  right to disclose such Confidential Information; or    (iv) is independently developed by the Receiving Party without reference to or  reliance upon the Disclosing Party’s Confidential Information.    (b) In addition, if the Receiving Party is required by a governmental authority  (including without limitation SEC reporting) or by order of a court of competent  jurisdiction to disclose any of the Disclosing Party’s Confidential Information, the  Receiving Party will give the Disclosing Party prompt written notice thereof and  the Receiving Party will take all reasonable and lawful actions to avoid or  minimize the degree of such disclosure. The Receiving Party will cooperate  reasonably with the Disclosing Party in any efforts to seek a protective order.    11.4 Publicity. Except to the extent required by Applicable Law, the rules of a stock exchange  on which securities of the disclosing party are listed, or as otherwise provided in this  Section 11.4 or in Section 11.3, neither Party will make any public statements or releases  concerning this Agreement or the transactions contemplated by this Agreement without  obtaining the prior written consent of the other Party, which consent will not be  unreasonably withheld, conditioned or delayed.    12. Ownership of Improvements.    12.1 Background Technology. All rights to and interest in Customer Technology will remain  the sole and exclusive property of Customer, and all rights to and interest in Hovione  

 

Page 16          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Technology will remain the sole and exclusive property of Hovione. Customer grants  Hovione during the Term the right to use Customer Technology and Customer  Improvements for the sole and limited purpose of fulfilling Hovione’s obligations under  this Agreement.    12.2 Customer Improvements. All Customer Improvements will be the sole and exclusive  property of Customer, and such Customer Improvements are hereby assigned to Customer  or its designee by Hovione, its Affiliates and their respective employees, personnel and  agents, without any additional compensation to Hovione. Hovione will take all such steps  as Customer may reasonably request and at Customer’s expense to vest in Customer or  Customer’s designee, ownership of all Customer Improvements.    12.3 Hovione Improvements. All Hovione Improvements will be the sole and exclusive property  of Hovione, and such Hovione Improvements are and will be assigned by Customer, its  Affiliates and their respective employees, personnel and agents to Hovione or its designee  without any additional compensation to Customer. Customer will take all such steps as  Hovione may reasonably request and at Hovione’s expense to vest in Hovione or Hovione’s  designee, ownership of all Hovione Improvements. Notwithstanding the foregoing,  Hovione hereby grants Customer a non-exclusive, worldwide, royalty-free, paid-up  license, including the right to grant sublicenses subject to the terms of Section 12.4, to use  those Hovione Improvements that are related to the Product and necessary for the  Manufacture or processing of the Product solely for the purpose of Customer or its designee  Manufacturing or processing such Product.    12.4 Requirements for Sublicenses. Notwithstanding the foregoing, Customer will not grant a  sublicense of its rights to Hovione Improvements under Section 12.3 to any bona fide  competitor of Hovione without Hovione’s prior written consent, which consent shall not  be unreasonably withheld, conditioned or delayed if such Hovione Improvement is  necessary. “Necessary” as used herein shall mean [*]. Further, Customer will be solely  responsible for the actions of any Third Party to which Customer sublicenses its rights to  Hovione Improvements under Section 12.3 and will indemnify and hold Hovione harmless  against all costs, expenses, damages, or losses of any nature arising out of such  sublicensee’s use of Hovione Improvements, including, but not limited to, any use of such  Hovione Improvements outside the scope of Customer’s license under Section 12.3.  Customer will cause any such sublicensee to be bound by, and to comply with, (a) the  limitations on Customer’s use of the Hovione Improvements under the license granted in  Section 12.3, and (b) confidentiality requirements relating to the Hovione Improvements  and other Hovione Confidential Information that are no less strict than those contained in  this Agreement.    12.5 Patents. Customer will have the exclusive right to prepare, file, prosecute, maintain and  defend, at its sole expense, any patent applications and/or patents that claim Customer  Improvements. Hovione will have the exclusive right to prepare, file, prosecute, maintain  and defend, at its sole expense, any patent applications and/or patents that claim Hovione  Improvements.    13. Indemnification; Liabilities; and Insurance.    13.1 Indemnification by Hovione. Hovione will indemnify and hold harmless Customer and, its  

 

Page 17          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   Affiliates, and their respective directors, officers, employees and agents (“Customer  Indemnitees”) from and against any and all damages, liabilities, claims, costs, charges,  judgments and expenses, including reasonable attorneys’ fees (collectively “Losses”) that  may be sustained, suffered or incurred by a Customer Indemnitee in connection with any  and all actions, claims or demands that may be brought or instituted against a Customer  Indemnitee by any Third Party, in each case to the extent such Losses arise directly from  or by reason of: [*].    13.2 Indemnification by Customer. Customer will indemnify and hold harmless Hovione and its  Affiliates, and their respective directors, officers, employees and agents (“Hovione  Indemnitees”) from and against any and all Losses that may be sustained, suffered or  incurred by a Hovione Indemnitee in connection with any and all actions, claims or  demands that may be brought or instituted against a Hovione Indemnitee by any Third  Party, in each case to the extent such Losses arise directly from or by reason of: [*].    13.3 Indemnification Procedure. Each indemnified Party agrees to give the indemnifying Party  prompt written notice of any matter upon which such indemnified Party intends to base a  claim for indemnification under this Section 13.1 or 13.2, as applicable. The indemnifying  Party will have the right, but not the obligation, to defend, negotiate, and settle such claims;  provided, however, that the indemnified Party will be entitled to participate in the defense  of such matter and to employ counsel at its expense to assist therein. The Party seeking  indemnification will provide the indemnifying Party with such information and assistance  as the indemnifying Party may reasonably request, at the expense of the indemnifying  Party.    13.4 Limitations of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT  TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY  SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING  OUT OF THIS AGREEMENT, HOWEVER CAUSED, AND REGARDLESS OF ANY  THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER  PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES;  PROVIDED, HOWEVER, THAT THIS LIMITATION WILL NOT APPLY TO (i)  DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF  CONFIDENTIALITY AND NON-USE IMPOSED UNDER SECTION 11, OR (ii)  PERSONAL INJURY OR DEATH.    13.5 Notwithstanding anything to the contrary in this Agreement, the total liability of Hovione  for losses or damages under this Agreement are limited to [*].    

 

Page 18          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   13.6 Insurance. During the Term and for [*] thereafter, Hovione will carry, with financially  sound and reputable insurers, insurance coverage (including worker’s compensation at or  above the applicable statutory limits, comprehensive liability coverage with contractual  liability, products liability and such other coverage as may be reasonably necessary or  useful in connection with the conduct of its business in such amounts as are customary for  well insured companies engaged in similar businesses and sufficient to support its  obligations and performance under this Agreement but in any event not less [*]. Upon the  request of Customer, Hovione will provide Customer with a certificate of insurance  evidencing such coverage, and providing that ten (10) days advance written notice will be  given to Customer of any material change or cancellation in coverage or limits. Hovione  may use of self-insurance, and the use of primary and excess limits to achieve the total  required limits is acceptable.    14. Miscellaneous.    14.1 Assignment. This Agreement may not be assigned or otherwise transferred by either Party  without the prior written consent of the other Party; provided, however, that either Party  may, without such consent, but with notice to the other Party, assign this Agreement, in  whole or in part, (a) in connection with the transfer or sale of all or substantially all of the  assets of the assigning Party or the line of business to which this Agreement relates, (b) to  the successor entity or acquirer in the event of the merger, consolidation or change of  control of the assigning Party, or (c) to an Affiliate of the assigning Party.    14.2 Severability. If any provision of this Agreement becomes or is declared by a court of  competent jurisdiction to be illegal, unenforceable or void, this Agreement will continue in  full force and effect without said provision. If any provision of this Agreement is held to  be excessively broad, it will be reformed and construed by limiting and reducing it so as to  be enforceable to the maximum extent permitted by law. The Parties will use their  commercially reasonable efforts to replace the invalid, illegal or unenforceable provision(s)  with valid, legal and enforceable provision(s), which, insofar as practical, implement the  intent of the Parties.    14.3 Notices. All notices which are required or permitted hereunder will be made in writing and  delivered personally, sent by telecopier (and promptly confirmed by personal delivery,  registered or certified mail or overnight courier), sent by nationally-recognized overnight  courier or sent by registered or certified mail, postage prepaid, return receipt requested,  addressed as follows:    If to Hovione, to: Hovione Farmaciencia, SA  Attn: [*]  Sete Casas  2670 Loures, Portugal    With a copy to: [*]    If to Customer, to: Seagen Inc.  Attn: [*] 21823 SE 30th  Drive Bothell, WA 98021  USA    

 

Page 19          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   With a copy to: [*]      or to such other address as the Party to whom notice is to be given may have furnished to  the other Party in writing. Any such notice will be deemed to have been given (a) when  delivered, if personally delivered or sent by telecopier on a Business Day, (b) on the  Business Day after dispatch, if sent by nationally-recognized overnight courier, or (c) on  the third Business Day following the date of mailing, if sent by first class mail.    14.4 Choice of Law. This Agreement will in all events and for all purposes be governed by, and  construed in accordance with, the laws of [*] without regard to any choice of law principle  that would dictate the application of the law of another jurisdiction. The Parties agree that  the provisions of the United Nations Convention on Contracts for the International Sale of  Goods will not apply to this Agreement, and are hereby expressly excluded.    14.5 Entire Agreement; Amendment. This Agreement constitutes the entire agreement of the  Parties with regard to its subject matter, and supersedes all previous written or oral  representations, agreements and understandings between Customer and Hovione,  including, without limitation, the Master Services Agreement between Customer and  Hovione Inter Ltd. dated [*]. This Agreement, including any purchase order issued  hereunder, may only be changed by a writing signed by authorized representatives of both  Parties.    14.6 Conflicts. If there is any conflict, discrepancy, or inconsistency between the terms of this  Agreement and the Quality Agreement, or any purchase order or other form used by the  Parties hereunder, the terms of this Agreement will take precedence and control, except  that solely with respect to all quality assurance matters, the terms of the Quality Agreement  will take precedence and control.    14.7 Headings; Construction. The Section headings are intended for convenience of reference  only and are not intended to be a part of, or to affect the meaning or interpretation of, this  Agreement. Both Parties have participated equally in the formation of this Agreement and  the language of this Agreement will not be presumptively construed against either Party.    14.8 No Partnership or Employment Relationship. All Services will be rendered by Hovione as  an independent contractor for federal, state and local income tax purposes and for all other  purposes. Hovione will not in any way represent itself to be a partner or joint venturer of  or with Customer. This Agreement does not create an employer-employee relationship  between Customer on the one hand and Hovione or any employee, subcontractor, Affiliate  of Hovione, or any Hovione personnel on the other. Hovione is acting under this Agreement  as an independent contractor with full power and authority to determine the means, manner  and method of performance of Hovione’s duties. Each Party will be responsible for and  will withhold and/or pay any and all applicable federal, state or local taxes, payroll taxes,  workers’ compensation contributions, unemployment insurance contributions, or other  payroll deductions from the compensation of such Party’s employees and other personnel.  Each Party understands and agrees that it is solely responsible for such matters and that it  will indemnify the other Party and hold the other Party harmless from all claims and  demands in connection with such matters.    14.9 Waiver. Any delay in enforcing a Party’s rights under this Agreement, or any waiver as to  

 

Page 20          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.   a particular default or other matter, will not constitute a waiver of such Party’s rights to the  future enforcement of its rights under this Agreement, except with respect to an express  written waiver relating to a particular matter for a particular period of time signed by an  authorized representative of the waiving Party, as applicable.  14.10 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of  which will be deemed an original, but all of which together will constitute one and the same  instrument.        << Signature Page Follows >>  

 

Page 21          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.     IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly  authorized representatives, effective as of the Effective Date.    SEAGEN INC.    By: /s/ Clay Siegall     Name:  Clay Siegall   Title: President and CEO____________________      Date: 09-Jul – 2021   16:36 PDT    HOVIONE FARMACIENCIA, SA    By: /s/ Marco Gil     Name: Marco Gil  Title: VP Sales____________________________                 Date: 11 – Jul – 2021    05:32 PDT        HOVIONE FARMACIENCIA, SA    By: /s/ Jean – Luc Herbeaux   Name:  Jean – Luc Herbeaux   Title: COO                      Date: 11 – Jul – 2021   10:23 PDT   

 

  Page 22    [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,  HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT  TREATS AS PRIVATE OR CONFIDENTIAL.     EXHIBIT A  SPECIFICATIONS  [*]    {7 pages omitted}  

 

  Page 23      [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS  BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS  PRIVATE OR CONFIDENTIAL.      EXHIBIT B    MINIMUM ANNUAL PURCHASE COMMITMENT    [*]      

 

  Page 24    [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS  BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS  PRIVATE OR CONFIDENTIAL.      EXHIBIT C  HOVIONE STANDARD FEES  [*] 

 

  Page 25          [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS  BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS  PRIVATE OR CONFIDENTIAL.       EXHIBIT D  PURCHASE PRICE  [*]

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