Common use of Supply Agreement Clause in Contracts

Supply Agreement. Unless the Parties agree otherwise, [*] following the Effective Date, the Parties will negotiate in good faith and enter into a supply agreement (the “Supply Agreement”) consistent with the supply terms and conditions in this Section 5.1 for the supply of the Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization in the Field in the Territory. (a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Betta.

Supply Agreement. Unless The manufacture and supply of Albuferon and the Collaboration Product to be provided by the Parties agree otherwise, [*] following the Effective Date, the Parties will negotiate in good faith hereunder shall be subject to a separate supply and enter into a supply quality agreement (the “Supply Agreement”) consistent with to be negotiated between the supply terms and conditions in this Section 5.1 for the supply parties hereto within [***] of the Licensed Antibodies Effective Date. Such Supply Agreement shall include any and all standard and customary terms addressing all aspects of the manufacturing process for Albuferon and the Collaboration Product and the responsibilities of each Party with respect thereto, including the establishment of a manufacturing subcommittee of the JDC (or as a standalone committee if agreed by the Parties), audit provisions for confirming COGS and possible COGS reduction incentives/programs. If the Parties do not agree upon the terms of a Supply Agreement, such dispute shall be subject to the provisions of Section 18 herein. The Supply Agreement shall also contain provisions that in the event that an issue arises while HGS is manufacturing supplies of Albuferon and/or NVS is manufacturing supplies of Collaboration Product which would significantly impact the supplying Party’s ability to deliver the mutually agreed amount of Albuferon and/or Collaboration Product to the mutually agreed quality specifications, including issues related to capacity, safety or quality, then the Parties must meet to consider and mutually determine via the manufacturing sub-committee of the JDC what reasonable manufacturing alternatives are available to the Parties, including, but not limited to, granting the other Party the right to manufacture Albuferon or Collaboration Product, as the case may be or, if such other Party is not capable or willing to manufacture, to have a Third Party manufacture Albuferon or the Collaboration Product. In the United States, all Collaboration Product [***] drug product format in final form by Agenus to Betta for Development INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. labels, commercial packs and Commercialization promotional material in the Field Territory shall contain the HGS and NVS names and logos in equal prominence to the Territory. (a) The Parties agree that extent legally permissible. If requested by NVS, the Supply Agreement should be consistent with will also set forth the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] process for establishing a second source of supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for useAlbuferon. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Betta.

Supply Agreement. Unless Until the Parties enter into the Supply Agreement, the Parties agree otherwiseto the following terms, [*] following which terms, to the Effective Dateextent applicable, shall be included in the Parties Supply Agreement: 5.1. Pro-Dex will negotiate be Monogram’s exclusive manufacturer and supplier for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in good faith writing to Monogram: (i) the reference data (from simulated use studies) used to inform the warranty period; (ii) the framework for validating processes for receiving contaminated field units for repairs and enter into a supply agreement servicing; (iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Supply AgreementQualified Manufacturers”). The higher of (x) consistent with the supply terms and conditions in this Section 5.1 for the supply average of the Licensed Antibodies in a [*] drug product format in final form bids provided by Agenus the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to Betta for Development manufacture and Commercialization in supply that Product at the Field in the Territory. (a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] lesser of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting one hundred and other typical supply terms and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) Bettathe original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use.approval (not to be unreasonably withheld); and (biv) As long as Agenus supplies the Licensed Antibodies lead time required by Pro-Dex to Betta deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for Commercialization in that same Product from at least three Qualified Manufacturers. The higher of (x) the Field in average of the Territorybids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, no more than once per [*] or more frequently as reasonably required Pro-Dex will have the right to address any quality issues, and upon not less than [*] prior written notice, Agenus will supply the Products with a lead time equal to the lesser of (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where two hundred percent (200%) of the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, Qualified Lead Time Bid or (ii) accommodate Betta’s reasonable request the original bid submitted by Pro-Dex. If Pro-Dex does not elect to audit manufacture and supply that Product at such lead times, Monogram may outsource the parts manufacturing and supply of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies Product to a Qualified Manufacturer selected by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms Monogram and subject to the requirements and Pro-Dex’s approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above (not to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Bettaunreasonably withheld).

Supply Agreement. Unless the Parties agree otherwise, [*] following Within ten (10) days after the Effective Date, the Parties will negotiate in good faith and enter into a separate manufacturing and supply agreement in the form attached hereto as Exhibit C (the “Supply Agreement”) consistent pursuant to which, subject to a satisfactory audit by Servier, CTI (or an Affiliate) by itself or through any Third Party contract manufacturer approved by Servier (the “CMOs”) shall supply to Servier, Servier’s requirements for Licensed Product (subject to Section 9.6) for all countries in the Servier Territory. The Parties acknowledge that CTI is in the process of validation of a new supplier for Drug Product, which has been approved in principle by Servier. Notwithstanding the foregoing, Servier will have the right to perform a quality review with the supply current and prospective sources to verify their ability to meet global quality standards. The Supply Agreement shall comply with the terms and conditions in of this Section 5.1 Agreement and will also provide that: 9.2.1 CTI (or an Affiliate) by itself or through CMO(s) shall maintain a qualified site or sites for the Manufacture **. The qualified site(s) is or are intended to provide a secure adequate global supply of ** based upon current sales projections. Servier may use alternate site(s) for the Manufacture ** solely for the Servier ex-EU Territory and ** for the Servier Territory, and at its sole cost and expense, or otherwise in case of supply failure pursuant to the Supply Agreement (the “Alternate Site Option”). Unless otherwise agreed, responsibility for oversight and management of such alternate site(s), as well as any and all associated costs, shall be borne solely by Servier. CTI shall have audit rights with respect to any such alternate site(s) in accordance with Section 9.8. Servier may order that additional ** be held in reserve by Servier for its safety stock requirements at its sole cost and expense. 9.2.2 Based upon Servier’s forecasted need, CTI will schedule and coordinate the Manufacture of a full batch or batches of approximately ** unlabeled vials (per batch), and arrange storage at the vendor’s facility at Servier’s expense if needed. Servier will be required to place orders with CTI and be responsible for cancellation fees and immediate reimbursement of the cost of the batch in accordance with the Supply Agreement. Servier may request, and CTI will make reasonable efforts to supply, partial batches from its commercial supply chain to minimize excess Servier inventory and carrying cost. 9.2.3 In case of a worldwide shortage ** available to CTI (other than the Servier safety stock, which shall be allocated solely to Servier), the **, if any, shall be allocated between Servier and CTI ** of the Licensed Antibodies in a [Product over the *] drug product format in final form by Agenus to Betta for Development and Commercialization in * period preceding the Field in the Territoryshortage. (a) The Parties agree that 9.2.4 Servier shall place an initial purchase order for **, including any country-specific **. ** covering the Supply Agreement should be consistent with respective **. Such purchase orders in aggregate **. If ** are not available at the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b)time of purchase order, Agenus will [CTI shall supply such product *] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting within ** if **. CTI shall invoice Servier for each such ** order and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records invoice shall be required to enter into separate confidentiality agreements, if not expressly covered payable within ** after the invoice date by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by BettaServier.

Supply Agreement. Unless By written notice provided to GSK not later than [… * …] (the “Interim Supply Notice”), XenoPort may request that GSK manufacture and supply (or arrange for the manufacture and supply of) quantities of Product, for commercialization by or on behalf of XenoPort in the Territory, with such supply obligation to commence on the date XenoPort submits to GSK the Interim Supply Notice in accordance with this Section 4.5 and continue until October 30, 2013 (the “Supply Term”), at a supply price and upon terms to be agreed by the Parties agree otherwise, [*] following the Effective Date, in a separate supply agreement. Any such supply agreement entered into by the Parties will negotiate in good faith and enter into a supply agreement shall be consistent with the terms set forth on Schedule 4.5 attached hereto (the “Supply Agreement”) consistent ). The Parties shall use Commercially Reasonable Efforts to negotiate and execute the definitive written Supply Agreement promptly following the Termination Effective Date, [… * …] (provided, however, that the Parties shall have entered into an appropriate quality agreement covering responsibilities that will apply to the Product sold to XenoPort pursuant to this Section 4.5, including responsibilities for relevant quality assurance and quality control activities related thereto), [… * …]. If, in accordance with the supply terms and conditions in this Section 5.1 for the above, XenoPort requests that GSK provide interim supply of Product, the Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization in the Field in the Territory.following shall apply: (a) The Parties agree that XenoPort shall issue firm purchase orders (each, a “Firm Order”) for those quantities of Product to be supplied to XenoPort during the term of the Supply Agreement should Agreement, which shall be consistent with the following principle: prior provided to the Manufacturing Technology Transfer Completion pursuant GSK [… * …] XenoPort may issue up to Section 5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use… * …]. (b) As long The Firm Orders may be delivered electronically or by other means to such location as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, GSK shall designate and upon not less than [*] prior written notice, Agenus will shall include (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies … * …]. Product quantities shall be ordered by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and XenoPort in accordance with agreed minimum quantities and consistent with agreed forecasted demand in effect for such partyProduct, in each case, as set forth on Schedule 4.5B. (c) If after GSK’s securityreview of XenoPort’s Firm Orders, safety and other rules and requirements. Persons auditing the facilities, books or records questions arise based on [… * …] Once all questions relating to [… * …] GSK shall be required deemed to enter into separate confidentiality agreementshave accepted such Firm Order; provided, if however, that any delay in resolving such questions may impact the [… * …]. In the event that the Parties are not expressly covered by this Agreement and reasonably able to agree to quantities included in any Firm Order, [… * …] GSK shall abide proceed with supplying those quantities of Product that are agreed to by the safety protocols and standard operating procedures of Parties (and, therefore, not under review). XenoPort [… * …] (d) [… * …] (e) If XenoPort issues the audited facility while Interim Supply Notice to GSK, then on site. Any authorized audits of third party facilities that same date, XenoPort shall be provide to GSK all required artwork to update Labels and/or Labeling (the “Artwork”) for use on the terms and subject Product supplied pursuant to the requirements and approval of any such third party. For Supply Agreement, which shall include, among other things, XenoPort’s NDC number(s) for the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by BettaProduct, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Bettathe following terms of this * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Supply Agreement. Unless the Parties agree otherwise, Within [***] following the Effective Date, the Parties will negotiate in good faith and enter into execute a commercial supply agreement for the Licensed Product in its current formulation (the “Supply Agreement”), and accompanying quality agreement pursuant to which (a) consistent with the Eidos will supply terms to Bayer Licensed Product manufactured by or on behalf of Eidos and conditions in this Section 5.1 (b) Bayer shall purchase such Licensed Product from Eidos, for the supply sole purpose of the Exploitation of Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization Product in the Field in the Licensed Territory. . The Supply Agreement shall, at a minimum, reflect the supply terms set forth on Schedule 6.1 hereto, including for clarity, terms with respect to [***]. Furthermore, Bayer acknowledges that Eidos is a party to (a) The Parties agree that [***] and (b) [***] pursuant to which [***] manufactures and supplies the Licensed Product, and accordingly, except as otherwise agreed in Schedule 6.1, the Supply Agreement should shall be in form and substance substantially consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] supply the Licensed Antibodies in a **]. Bayer shall use Commercially Reasonable Efforts to [*] drug product format in final form **]. Notwithstanding the foregoing, Bayer cannot refuse to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject **]. Eidos shall use Commercially Reasonable Efforts to (i) reasonable forecasting and other typical facilitate Bayer’s entering into such a supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per agreement with [***] and [***]. Bayer shall not be restricted from obtaining supply from any other qualified contract manufacturers, including contract manufacturers that Eidos may appoint from time to time during the Term, with respect to Licensed Products or more frequently as components thereof and from directly ordering Licensed Products or components thereof from such other contract manufacturers; provided, that [***]. Each Party shall inform the other Party through the JSC and its Sub-Committees reasonably required in advance about any plan to address establish a supply relationship with any quality issuesnew contract manufacturer for Licensed Products or components thereof, and upon not less than such information the Parties shall in good faith discuss and coordinate entering into a joint supply agreement with such contract manufacturer. In the event of a supply shortfall of a contract manufacturer that is at the time of such shortfall used by both Parties, the Parties shall, through the JSC and its Sub-Committees, [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Betta.

Supply Agreement. Unless the Parties agree otherwise, Within [* * *] following after the Effective Datemeeting referenced in Section 8.1, Durect shall notify Zogenix in writing if Durect elects to supply Zogenix’s Phase III Clinical Trial and commercial requirements for Product or Product Formulation, as applicable, in the Parties will negotiate in good faith Territory. If Durect so elects to supply, Durect and Zogenix shall each use Commercially Reasonable Efforts to enter into a supply agreement (the “Supply Agreement”) consistent with and associated technical agreement governing QA (“Technical Agreement”) providing for the supply by Durect (by itself or through a Third Party manufacturer reasonably acceptable to Zogenix) of all of Zogenix’s and its Affiliates’ and Sublicensees’ commercial requirements (including Phase IV Clinical Trials) of Product or Product Formulation, as applicable, in the Territory. Each Party shall use Commercially Reasonable Efforts to enter into the Supply Agreement no later than [* * *] prior to the initiation of the first Phase III Clinical Trial. Product or Product Formulation, as applicable, supplied shall meet the specifications provided for in the Supply Agreement and associated Technical Agreement to be executed by each of the Parties hereto. Under the Supply Agreement, Zogenix shall pay Durect a transfer price for the Product or Product Formulation, as applicable, equal to Durect’s fully burdened manufacturing Cost, such term to be defined in the Supply Agreement [* * *], to produce Product or Product Formulation, as applicable, plus [* * *]). The Supply Agreement shall also contain provisions for back-up sources of supply and other customary terms and conditions in this Section 5.1 for the supply of the Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization in the Field in the Territory. (a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in type of agreements. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the Field in the Territory where such supply is intended for use. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and information subject to the requirements confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by BettaExchange Commission.

Supply Agreement. Unless the Parties agree otherwise, [*] following (a) Within * after the Effective DateDate of this Agreement, the Parties will negotiate in good faith and parties shall enter into a supply agreement (the “Supply Agreement”) on reasonable and customary terms with respect to the preclinical, clinical and commercial supply arrangements contemplated in Section 8.1 for such Products and Program Carriers, including without limitation provisions for quality assurance and quality control, and in any event consistent with the supply terms and conditions summarized in this Section 5.1 for the supply of the Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization in the Field in the Territory. (a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use8.2. (b) As long as Agenus supplies Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products and the Licensed Antibodies Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to Betta for Commercialization in or provide services with respect to the Field in the TerritoryProgram Carrier will be subject to Genta’s prior approval, no more than once per [*] or more frequently as reasonably required not to address any quality issuesbe unreasonably withheld, and that the terms of each subcontract agreement shall be reasonably consistent with all of the requirements and limitations imposed upon Emisphere under the Supply Agreement. To the extent the Emisphere wishes to itself manufacture the Products or Program Carriers (as opposed to using a subcontractor), then the parties will negotiate in good faith the terms of such a proposed arrangement, including without limitation as to price and quality assurance. * denotes material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission. (c) Supply prices under the Supply Agreement for Program Carrier or finished Product supplied by Emisphere will not less than [exceed *] prior written notice. Genta shall supply the Gallium Salt to Emisphere free of charge, Agenus including shipping costs, for all Products to be manufactured by Emisphere. (d) The Supply Agreement will contain terms and conditions typically included in supply agreements for similar products at similar volumes and similar stages of development. Without limiting the generality of the foregoing, the parties intend that the Supply Agreement will include the following: (i) [*] accommodate Betta’s Provisions that require Genta, on a monthly basis, to provide Emisphere with a written * rolling forecast of its anticipated Product (or, as applicable, Program Carrier) demand (each a “Forecast”). It is anticipated that the quantities set forth in the first * of each Forecast will be treated as firm purchase orders, and that otherwise, each Forecast will be non-binding. It is also anticipated that Emisphere will generally be obligated to accept all purchase orders for Products (or, as applicable, Program Carrier) issued by Genta, except those that specify a delivery date less than * after the purchase order date. Lastly, and notwithstanding the foregoing, it is anticipated that Emisphere will not be obligated, but will agree to use commercially reasonable request efforts, to audit Agenus’ third party manufacturer facilities where manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the Licensed Antibodies supplied hereunder are Manufactured most recent estimate provided to Emisphere in order a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to assess compliance with GMP, Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreement. (ii) accommodate Betta’s reasonable request Provisions providing Genta with the right to audit reject any delivery of Product or Program Compound that does not conform to the parts of Agenus’ facilities that oversee the Manufacture applicable specifications (as established by mutual written agreement of the Licensed Antibodies parties) by Agenus’ third party manufacturer giving written notice to Emisphere of such rejection within 30 days after receipt of such delivery (or for defects not reasonably discoverable upon delivery, within 30 days after their initial discovery by Genta), along with mechanisms for resolving disputes as to Product or Program Compound conformity through the Licensed Antibodies in order use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to assess compliance with GMPconform to applicable specifications, and that provide for testing of such material for conformance with such specifications as well as for mechanisms for acceptance and rejection of such materials by Emisphere or its contract manufacturer. (iii) accommodate BettaProvisions permitting Genta, its Affiliates and Sublicensees manufacture or have manufactured finished Product and the Program Carrier in the event of certain material performance failures by Emisphere. (iv) Provisions specifying that any failure to perform, or delay in performance, by Emisphere under the Supply Agreement that arises from Genta’s reasonable request failure to audit Agenus’ books and records directly related supply Gallium Salt API as required to make Product within the Manufacture of such Licensed Antibodiestime required under the Supply Agreement, including such records provided shall not be deemed to Agenus be a breach by Agenus’ third party manufacturer Emisphere of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by BettaSupply Agreement.

Supply Agreement. Unless the Parties agree otherwise, Within [*] following the Effective Date**], the Parties will negotiate in good faith and enter into a supply agreement (the “Supply Agreement”) consistent with the supply terms and conditions in this Section 5.1 for the Manufacture and supply of the Licensed Antibodies in a [*] drug product format in final form Products by Agenus Company to Betta Licensee for Development and Commercialization in the Field in the Territory. Territory (the “Supply Agreement”). Unless otherwise agreed or required by applicable Laws, the Supply Agreement will specify that (a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b)Company will (or will cause its Affiliates to) Manufacture and supply, Agenus and Licensee will [*] supply exclusively purchase from Company, all of Licensee’s, its Affiliates’ and Sublicensees’ needs for the Licensed Antibodies in a [*] drug product format in final form to Betta Products for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where in their finished form and at a price equal to [***]; provided, however, that such supply is intended for use. price may not be greater than [***]; (b) As long as Agenus supplies such Licensed Products will be compliant with all requirements of the applicable Regulatory Authority(ies) and applicable Laws; (c) such Licensed Products supplied by Company to Licensee for a given vial will come from the drug substance Manufactured by or on behalf of Company; and (d) other customary supply terms, including [***]. Notwithstanding the foregoing, the Supply Agreement will further specify that if Company, its Affiliated Entities or sublicensees identifies, secures or engages a CMO for the Manufacture and supply of the Licensed Antibodies Products and the Fully Burdened Manufacturing Cost for such CMO to Betta for Commercialization in Manufacture and supply the Field in Licensed Products is lower than the Territoryprice charged by Company to Manufacture and supply Licensed Products under the Supply Agreement, no more than once per [*] or more frequently as reasonably required to address any quality issuesthen (x) Company will inform Company of such CMO, and upon not less than [*] prior written notice(y), Agenus at Company’s election, Company will either (i) [*] accommodate Bettareduce the price to Manufacture and supply Licensed Products under the Supply Agreement to match such CMO’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMPFully Burdened Manufacturing Cost, or (ii) accommodate Betta’s reasonable request use Commercially Reasonable Efforts to audit the parts of Agenus’ facilities that oversee provide, or cause such CMO to provide, an opportunity to engage such CMO for the Manufacture and supply of Licensed Products to Licensee on substantially the Licensed Antibodies by Agenus’ third party manufacturer of same terms as those provided or proposed to be provided to Company, its Affiliated Entities or sublicensees (in which case the Licensed Antibodies exclusivity obligations described in order the foregoing clause (a) will not apply with respect to assess compliance with GMPsuch CMO); provided, if Licensee fails to secure such Manufacture and (iii) accommodate Betta’s reasonable request supply from such CMO, then Company will use Commercially Reasonable Efforts to audit Agenus’ books purchase the applicable Manufacturing services from such CMO and records directly related to the Manufacture of will supply such Licensed AntibodiesProducts to Licensee on substantially the same terms as those provided by such CMO to Company, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*]its Affiliated Entities or sublicensees, during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Bettaas applicable.

Supply Agreement. Unless the Parties agree otherwise, [*] following the Effective Date, the Parties will negotiate in good faith and enter into a supply agreement (the “Supply Agreement”) consistent with the supply terms and conditions in this Section 5.1 for the supply of the Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization in the Field in the Territory.‌ (a) The Parties will work expeditiously and in good faith to negotiate and enter into a non- exclusive supply agreement (the "Supply Agreement") within 60 days following the Effective Date, which agreement will include at a minimum the following terms (together with such other terms as are customary in commercially analogous supply agreements, including with respect to insurance requirements of each Party):‌ (i) the Company Parties shall purchase from the Partner, and the Partner shall sell to the Company Parties (A) an agreed upon percentage of the Company Parties' total annual inventory requirements of Branded CBW Cannabis Products, to a maximum of up to 50% of such annual inventory requirements, and (B) an agreed upon percentage of the Company Parties' total annual inventory requirements of Cannabis Products used as inputs by the Company Parties for the creation and development of Branded Company Cannabis Products ("Input Cannabis Products"), to a maximum of up to 50% of such annual inventory‌ requirements, subject in each case to mutually agreed adjustments for the purposes of ensuring that the Company Parties and their franchisees have sufficiently diverse product inventories and are not exposed to unreasonable supply risk; (ii) the Company Parties will ensure that all Cannabis Products sold by the Partner to the Company Parties will be stocked on the highest-visibility shelf space available at retail locations operated by the Company Parties and their franchisees, and will not be subject to any slotting, promotional, advertising or similar stocking or display fees or charges in connection therewith; (iii) subject to compliance with Applicable Law, including the obtaining by each Party of all necessary licenses and approvals:‌ (A) the Partner Parties will sell Branded CBW Cannabis Products and Unbranded Cannabis Products to Spirit Leaf at wholesale prices, and the Parties agree that such wholesale prices may be higher than then current market prices for similar Cannabis Products if the Parties determine that revenue-sharing between them is best accomplished by the Partner Parties earning a portion of their revenue allocation through the direct sale of Branded CBW Cannabis Products and Unbranded Cannabis Products to Spirit Leaf;‌ (B) Spirit Leaf may sell Branded CBW Cannabis Products and Unbranded Cannabis Products, or create and sell Branded Company Cannabis Products using Unbranded Cannabis Products, either directly (including through one or more public or private intermediaries, procuring agents, institutional purchasers or other similar entities) or through its franchisees; and (C) unless the Parties have determined to effect their revenue-sharing agreement through the sales contemplated in Section 2.3(a)(iii)(A), the Partner will be entitled to earn and be paid a fee or be provided some other mutually agreeable financial benefit or accommodation to ensure that it is put in a substantially similar financial position as if it had elected to earn and be paid a revenue-sharing allocation, as agreed upon by the Parties in the Supply Agreement should be consistent with and as contemplated in Section 2.3(a)(iii)(A), it being understood that such benefit or accommodation may include a portion of the following principle: prior franchise or royalty fees (or similar fees) charged by Spirit Leaf to its franchisees or some other mutually agreeable fee or payment. (iv) the Parties will, through each Party's Relationship Manager, on an annual basis, or as more frequently as the Parties may jointly determine, discuss and analyze the suitability, terms and effectiveness of the profit-sharing framework set out in Section 2.3(a)(iii) relative to each Party's objectives and concerns, and make such adjustments, if any, to such profit-sharing framework as the Parties may jointly agree; (v) independently market, promote and advertise the other Party and its business by producing professional quality content including text, pictures and video content ("Promotional Content") relating to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b), Agenus will [*] supply promotion of the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of other Party and its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxesbusiness, subject to each Party's branding requirements;‌ (ivi) reasonable forecasting distribute Promotional Content through their respective retail outlets (including corporate-owned and other typical supply terms franchised locations) and media networks, including magazines, trade-shows, newsletters, websites, franchisee communications and social media; (iivii) Betta’s procurement use Promotional Content in furtherance of all import permits increasing brand visibility and other approvals needed awareness of each Party's business and products, including through active and continuous product placement, endorsements, cross-promotions and "mentions", directly or indirectly, through the Parties respective networks, including social media networks; and (viii) jointly develop Promotional Content for such Development and Commercialization in the Field in the Territory where such supply is intended for usepurpose of creating media campaigns oriented to mass-media channels. (b) As long as Agenus supplies The Parties acknowledge that the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture entering into of the Licensed Antibodies by Agenus’ third party manufacturer Supply Agreement is a material condition of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and a material inducement to the entering into of this Agreement. (c) Until the Supply Agreement is entered into, the Parties agree that they shall abide work in good faith to give effect to the purpose and spirit of this Section 2.3. (d) Upon execution and delivery thereof by the safety protocols and standard operating procedures of Parties, the audited facility while on site. Any authorized audits of third party facilities shall be on Supply Agreement will supersede the terms of this Section 2.3 in all respects. (e) For greater certainty, any reference in this Section 2.3 to a franchisee of a Company Party will be deemed to refer to a franchisee of Spirit Leaf and subject to the requirements and approval not a franchisee of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by BettaWatch It!.

Supply Agreement. Unless the Parties agree otherwise, Within [***] following after the Effective DateDate (or such other period as agreed by the Parties), the Parties will negotiate in good faith and enter into shall agree on a clinical supply agreement between the Parties pursuant to which MTEM would supply [***] as elected by Takeda, for the Phase I Program and (with MTEM’s written approval) thereafter until the “completion of the Technology Transfer, which supply agreement shall also include as Co-Development Costs any mutually agreed Manufacturing process development and supply chain development activities for the applicable Licensed Product (or ▇▇▇▇ ▇▇▇-▇ Fusion Protein) beyond the activities conducted pursuant to the [***] with GMP and shall be provided for up to [***] (and if needed prior to the Technology Transfer, such additional quantities as are reasonably requested by Takeda and can be supplied by MTEM through Commercially Reasonable Efforts). If no Supply Agreement”) consistent with the supply terms and conditions in this Section 5.1 Agreement for the supply of the Licensed Antibodies in a [***] drug product format is in final form by Agenus place within the time period specified above, then MTEM shall supply [***] on the terms set forth herein. If Takeda initiates the Technology Transfer from MTEM and no Supply Agreement for the supply of [***] is in place, MTEM shall have the right to Betta for complete (or have completed) the Manufacture of any work-in-process Licensed Products or Components thereof and all such costs shall be deemed Co-Development and Commercialization in Costs. The Joint Manufacturing Committee shall propose to the Field in the Territory. (a) The Parties agree that Parties, from time to time, amendments to the Supply Agreement should be consistent with the following principle: prior as needed to the meet Manufacturing Technology Transfer Completion pursuant to Section 5.2(b)objectives, Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta but for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliateclarity, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the Manufacture of such Licensed Antibodies, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records amendments shall be required to enter into separate confidentiality agreements, effective only if not expressly covered by this Agreement and shall abide by when the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject to the requirements and approval of any Parties duly execute such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by Bettaamendment.

Supply Agreement. Unless Reasonably in advance of the Parties agree otherwise, [*] following the Effective DateCommercialization of any Licensed Product, the Parties will shall negotiate in good faith and enter into a mutually acceptable supply agreement (the such initial agreement, as amended or extended, together with any subsequent agreements covering subject matter substantially similar thereto, a “Supply Agreement”) consistent with that will incorporate a related quality agreement and will set forth the supply terms and conditions by which SomaLogic shall manufacture and supply SOMAmer Reagents, either itself or through a Third Party contract manufacturer agreed by the Parties, to manufacture SOMAmer Reagents as reasonably required by Illumina (and Illumina’s Affiliates and Sublicensees) solely for use in the research, development or Commercialization of the Licensed Products, in each case in accordance with the terms and conditions set forth in this Section 5.1 8.11. Each such Supply Agreement shall include, at a minimum, the following terms and conditions: (i) specification of a manufacturing site, to be agreed by the Parties; (ii) the materials described on Exhibit F that include a summary of the required SOMAmer Reagents (as may be subsequently updated in the Supply Agreement) shall be supplied to Illumina at cost plus )***%***); provided that the total amount paid by Illumina for such materials described in Exhibit F shall not exceed (***$***) in total per sample (including all calibration ▇▇▇▇▇); and provided further that such amount shall decrease by at least (***%***) over each two (2)-Fiscal Year period starting on January 1, 2024 until the supply total amount paid by Illumina for such SOMAmer Reagents does not exceed (***$***) in total per sample (including all calibration ▇▇▇▇▇) at which point SomaLogic shall pass on to Illumina any further cost reductions that are achieved by SomaLogic; (iii) SomaLogic shall enable and validate a primary Third Party contract manufacturer of SOMAmer Reagents (the “Secondary Manufacturer”) solely for use in the research, development or Commercialization of the Licensed Antibodies in Products and, as a [*] drug product format in final form by Agenus to Betta for Development and Commercialization backup supplier in the Field event the Secondary Manufacturer is unable or unwilling to supply SOMAmer Reagents as required under the Supply Agreement, an additional Third Party contract manufacturer of SOMAmer Reagents solely for use in the Territory. (a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b)research, Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the Field in the Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (development or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and any VAT or other applicable transfer taxes, subject to (i) reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the Field in the Territory where such supply is intended for use. (b) As long as Agenus supplies the Licensed Antibodies to Betta for Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies Products (“Tertiary Manufacturer”); and (iv) for quality assurance purposes, in order to assess compliance connection with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related in addition to the Manufacture Supply Agreement, SomaLogic shall execute quality assurance agreements with each of such Licensed AntibodiesIllumina, including such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*]Secondary Manufacturer and the Tertiary Manufacturer, during business hours, without unreasonable disruption to the audited party’s normal business operations and in accordance each case with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if not expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be on the terms and subject conditions reasonably satisfactory to the requirements and approval of any such third party. For the avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to accommodate an audit request by BettaIllumina.