Common use of Supply Agreement Clause in Contracts

Supply Agreement. (a) Within * after the Effective Date of this Agreement, the parties shall enter into a supply agreement (“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 terms summarized in this Section 8.2. (b) Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products and the Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect to the Program Carrier will be subject to Genta’s prior approval, not to be 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 exceed *. Genta shall supply the Gallium Salt to Emisphere free of charge, 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) 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreement. (ii) Provisions providing Genta with the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform 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) Provisions 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 failure to supply Gallium Salt API as required to make Product within the time required under the Supply Agreement, shall not be deemed to be a breach by Emisphere of the Supply Agreement.

Supply Agreement. The Parties shall decide, through the JDC, and as reflected in the terms of the Supply Agreement, a mutually acceptable supply chain for the manufacture of the Product for use in clinical trials, including which Party will be responsible for oversight, negotiations and management of Third Party vendors responsible for manufacturing the Product; provided, however, that neither Party will be obligated to use the same supply chain or to enter into joint contractual arrangements with one another or Third Parties relating to the manufacture of the Product. On or before a date to be established by the ESC but in no event later than ninety (a90) Within * days after the Effective Date of this AgreementDate, the parties Parties shall enter into a supply agreement governing the supply of Product to CTI for Development purposes (the “Supply Agreement”) on reasonable and customary terms with respect to (b) a quality agreement governing the preclinicalquality control, 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 terms summarized in this Section 8.2. (b) Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products and the Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect to the Program Carrier will be subject to Genta’s prior approval, not to be 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 validation of such a proposed arrangement, including without limitation as to price and quality assurance. Product (the ** denotes material Indicates that certain information contained herein has been omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission. (c) . Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. “Quality Agreement”). The terms of such Supply prices Agreement and such Quality Agreement shall be negotiated in good faith by the Parties and will contain customary terms and conditions that are consistent with this Agreement. The purchase price for the Product under the Supply Agreement Agreements will be Chroma’s cost of manufacture and such purchase price will be considered part of the Development Costs. In the event that CTI wishes to have Chroma supply the Product for Program Carrier or finished Product supplied by Emisphere will Commercialization purposes, the initial purchase price for such supply shall not exceed Chroma’s cost of manufacture plus *. Genta shall supply the Gallium Salt to Emisphere free of charge, 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) 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a Forecast*. The Supply Agreement will contain similar forecasting mechanisms provide appropriate technology transfer provisions (including provision of DMFs and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreement. (ii) Provisions providing Genta with the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform 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) Provisions permitting Genta, its Affiliates and Sublicensees manufacture or have manufactured finished Product and the Program Carrier other customary terms in the event industry) sufficient to enable CTI to Manufacture the Product for Commercialization in the Licensed Territory in advance of certain material performance failures any anticipated Product launch in the Licensed Territory. The Supply Agreement will provide that such technology transfer may be initiated by Emisphere. (iv) Provisions specifying that CTI at any failure to perform, or delay in performance, by Emisphere under time during the term of the Supply Agreement at CTI’s option by written notice and that arises from Genta’s failure Chroma will be obligated to provide such technology transfer. The Supply Agreement will also provide appropriate provisions to address supply Gallium Salt API as required to make Product within the time required related issues post termination under the Supply Agreement, shall not be deemed to be a breach by Emisphere each of the Supply Agreementtermination scenarios addressed in Sections 13.7 and 13.8.

Supply Agreement. Until the Parties enter into the Supply Agreement, the Parties agree to the following terms, which terms, to the extent applicable, shall be included in the Supply Agreement: 5.1. Pro-Dex will 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 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 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) Within * after the Effective Date of this Agreementmutually agreed upon by Monogram and Pro-Dex, the parties shall enter into a supply agreement (“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 terms summarized in this Section 8.2. (b) Emisphere ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall utilize a qualified Third Party subcontractor be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to perform its manufacturing obligations with respect to Products manufacture and supply that Product at the Program Carrier; provided that each subcontractor lesser of (i) one hundred and subcontract agreement fifty percent (and any material changes thereto150%) that of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not solely relate elect to or provide services with respect manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to the Program Carrier will be a Qualified Manufacturer selected by Monogram and subject to GentaPro-Dex’s prior approval, approval (not to be 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 exceed *. Genta shall supply the Gallium Salt to Emisphere free of charge, 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) 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreement. (ii) Provisions providing Genta with the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform 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) Provisions 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.; and (iv) Provisions specifying the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that any failure to performsame Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids 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, or delay in performance, by Emisphere under Pro-Dex will have the Supply Agreement that arises from Genta’s failure right to supply Gallium Salt API as required the Products with a lead time equal to make the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product within at such lead times, Monogram may outsource the time required under the Supply Agreement, shall manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not be deemed to be a breach by Emisphere of the Supply Agreementunreasonably withheld).

Supply Agreement. By written notice provided to GSK not later than [… * …] (athe “Interim Supply Notice”), XenoPort may request that GSK manufacture and supply (or arrange for the manufacture and supply of) Within * after quantities of Product, for commercialization by or on behalf of XenoPort in the Effective Date of Territory, with such supply obligation to commence on the date XenoPort submits to GSK the Interim Supply Notice in accordance with this AgreementSection 4.5 and continue until October 30, 2013 (the parties shall enter into “Supply Term”), at a supply price and upon terms to be agreed by the Parties in a separate supply agreement. Any such supply agreement entered into by the Parties shall be consistent with the terms set forth on Schedule 4.5 attached hereto (the “Supply Agreement”) on reasonable ). The Parties shall use Commercially Reasonable Efforts to negotiate and customary terms with respect 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 preclinical, clinical and commercial supply arrangements contemplated in Product sold to XenoPort pursuant to this Section 8.1 for such Products and Program Carriers4.5, including without limitation provisions responsibilities for relevant quality assurance and quality controlcontrol activities related thereto), and [… * …]. If, in any event consistent accordance with terms summarized in this Section 8.2the above, XenoPort requests that GSK provide interim supply of Product, the following shall apply: (a) 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, which shall be provided to GSK [… * …] XenoPort may issue up to [… * …]. (b) Emisphere The Firm Orders may be delivered electronically or by other means to such location as GSK shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products designate and the Program Carrier; provided that each subcontractor and subcontract agreement shall include (and any material changes theretoi) that does not solely relate to or provide services with respect to the Program Carrier will be subject to Genta’s prior approval, not to be unreasonably withheld, and that the terms of each subcontract agreement [… * …]. Product quantities shall be reasonably ordered by XenoPort in accordance with agreed minimum quantities and 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 (agreed forecasted demand in effect for such Product, in each case, 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.set forth on Schedule 4.5B. (c) Supply prices If after GSK’s review of XenoPort’s Firm Orders, questions arise based on [… * …] Once all questions relating to [… * …] GSK shall be deemed to have accepted such Firm Order; provided, however, that any delay in resolving such questions may impact the [… * …]. In the event that the Parties are not reasonably able to agree to quantities included in any Firm Order, [… * …] GSK shall proceed with supplying those quantities of Product that are agreed to by the Parties (and, therefore, not under the Supply Agreement for Program Carrier or finished Product supplied by Emisphere will not exceed *review). Genta shall supply the Gallium Salt to Emisphere free of charge, including shipping costs, for all Products to be manufactured by Emisphere.XenoPort [… * …] (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:[… * …] (ie) Provisions If XenoPort issues the Interim Supply Notice to GSK, then on that require Gentasame date, XenoPort shall provide to GSK all required artwork to update Labels and/or Labeling (the “Artwork”) for use 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product supplied pursuant to the Supply Agreement. (ii, which shall include, among other things, XenoPort’s NDC number(s) Provisions providing Genta with for the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform to applicable specificationsProduct, and that provide for testing the following terms 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 manufacturerthis * 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. (iii) Provisions 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 failure to supply Gallium Salt API as required to make Product within the time required under the Supply Agreement, shall not be deemed to be a breach by Emisphere of the Supply Agreement.

Supply Agreement. (a) Within * after the Effective Date of this Agreement[***], the parties shall Parties will negotiate in good faith and enter into a supply agreement for the Manufacture and supply of the Licensed Products by Company to Licensee for Development and Commercialization in the Field in the Territory (the “Supply Agreement”). Unless otherwise agreed or required by applicable Laws, the Supply Agreement will specify that (a) on reasonable Company will (or will cause its Affiliates to) Manufacture 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 controlsupply, and Licensee will exclusively purchase from Company, all of Licensee’s, its Affiliates’ and Sublicensees’ needs for the Licensed Products for the Development and Commercialization in any event consistent with terms summarized the Field in this Section 8.2. the Territory in their finished form and at a price equal to [***]; provided, however, that such price may not be greater than [***]; (b) Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to such Licensed Products and the Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect to the Program Carrier will be subject to Genta’s prior approval, not to be unreasonably withheld, and that the terms of each subcontract agreement shall be reasonably consistent compliant with all requirements of the requirements applicable Regulatory Authority(ies) 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. applicable Laws; (c) Supply prices under the Supply Agreement for Program Carrier or finished Product such Licensed Products supplied by Emisphere Company to Licensee for a given vial will not exceed *. Genta shall supply come from the Gallium Salt to Emisphere free drug substance Manufactured by or on behalf of charge, including shipping costs, for all Products to be manufactured by Emisphere. Company; and (d) The Supply Agreement will contain terms and conditions typically included in other customary supply agreements for similar products at similar volumes and similar stages of developmentterms, including [***]. Without limiting the generality of Notwithstanding the foregoing, the parties intend that the Supply Agreement will include further specify that if Company, its Affiliated Entities or sublicensees identifies, secures or engages a CMO for the following: (i) 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, Manufacture 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * supply of the most recent estimate provided to Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreement. (ii) Provisions providing Genta with the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform 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) Provisions permitting Genta, its Affiliates and Sublicensees manufacture or have manufactured finished Product Licensed Products and the Program Carrier in Fully Burdened Manufacturing Cost for such CMO to Manufacture and supply the event of certain material performance failures Licensed Products is lower than the price charged by Emisphere. (iv) Provisions specifying that any failure Company to perform, or delay in performance, by Emisphere under the Supply Agreement that arises from Genta’s failure to Manufacture and supply Gallium Salt API as required to make Product within the time required Licensed Products under the Supply Agreement, shall not be deemed then (x) Company will inform Company of such CMO, and (y), at Company’s election, Company will either (i) reduce the price to Manufacture and supply Licensed Products under the Supply Agreement to match such CMO’s Fully Burdened Manufacturing Cost, or (ii) use Commercially Reasonable Efforts to 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 same terms as those provided or proposed to be a breach provided to Company, its Affiliated Entities or sublicensees (in which case the exclusivity obligations described in the foregoing clause (a) will not apply with respect to such CMO); provided, if Licensee fails to secure such Manufacture and supply from such CMO, then Company will use Commercially Reasonable Efforts to purchase the applicable Manufacturing services from such CMO and will supply such Licensed Products to Licensee on substantially the same terms as those provided by Emisphere of the Supply Agreementsuch CMO to Company, its Affiliated Entities or sublicensees, as applicable.

Supply Agreement. (a) Within * after Unless the Parties agree otherwise, [*] following the Effective Date of this AgreementDate, the parties shall Parties will negotiate in good faith and 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 summarized and conditions in this Section 8.25.1 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) Emisphere shall utilize a qualified Third Party subcontractor As long as Agenus supplies the Licensed Antibodies to perform its manufacturing obligations 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 respect GMP, (ii) accommodate Betta’s reasonable request to Products 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 the Program Carrier; provided that each subcontractor (iii) accommodate Betta’s reasonable request to audit Agenus’ books and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect records directly related to the Program Carrier 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 Genta’s prior approval, not to be 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 approval of any such third party. For the Supply Agreement. To the extent the Emisphere wishes avoidance of doubt, Agenus will have satisfied its obligation in Section 5.1(b)(i) above to itself manufacture the Products or Program Carriers (as opposed [*] by asking its third party manufacturer 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 accommodate an audit by Emisphere will not exceed *. Genta shall supply the Gallium Salt to Emisphere free of charge, 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) 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 ordersBetta, and that otherwise, each Forecast in no event will Agenus 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreement. (ii) Provisions providing Genta with the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform 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) Provisions 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 failure to supply Gallium Salt API as required to make Product within the time required under the Supply Agreement, shall not be deemed exercise its own audit right in its agreement with any such third party manufacturer to be a breach accommodate an audit request by Emisphere of the Supply AgreementBetta.

Supply Agreement. (a) Within * after [***] following the Effective Date of this AgreementDate, the parties shall enter into a supply agreement (“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 terms summarized in this Section 8.2. (b) Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products and the Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect to the Program Carrier will be subject to Genta’s prior approval, not to be 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 Parties will negotiate in good faith and execute a commercial supply agreement for the terms of such a proposed arrangementLicensed Product in its current formulation (the “Supply Agreement”), including without limitation as to price and accompanying quality assurance. * denotes material omitted agreement pursuant to a Confidential Treatment Request which (a) Eidos will supply to Bayer Licensed Product manufactured by or on behalf of Eidos and filed separately with the Securities and Exchange Commission. (cb) Supply prices under the Supply Agreement for Program Carrier or finished Bayer shall purchase such Licensed Product supplied by Emisphere will not exceed *. Genta shall supply the Gallium Salt to Emisphere free of charge, including shipping costsfrom Eidos, 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 the sole purpose of development. Without limiting the generality Exploitation of the foregoing, the parties intend that the Supply Agreement will include the following: (i) Provisions that require Genta, on a monthly basis, to provide Emisphere with a written * rolling forecast of its anticipated Licensed 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 Field in 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a ForecastLicensed Territory. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta shall, at a minimum, reflect the supply terms set forth on Schedule 6.1 hereto, including for clarity, terms with respect to Gallium Salt API required for the manufacture of Product [***]. Furthermore, Bayer acknowledges that Eidos is a party to (a) [***] and (b) [***] pursuant to which [***] manufactures and supplies the Licensed Product, and accordingly, except as otherwise agreed in Schedule 6.1, the Supply Agreement. (ii) Provisions providing Genta Agreement shall be in form and substance substantially consistent with the right [***]. Bayer shall use Commercially Reasonable Efforts to reject [***]. Notwithstanding the foregoing, Bayer cannot refuse to [***]. Eidos shall use Commercially Reasonable Efforts to facilitate Bayer’s entering into such a supply agreement with [***] and [***]. Bayer shall not be restricted from obtaining supply from any delivery of Product other qualified contract manufacturers, including contract manufacturers that Eidos may appoint from time to time during the Term, with respect to Licensed Products or Program Compound components thereof and from directly ordering Licensed Products or components thereof from such other contract manufacturers; provided, that does not conform to [***]. Each Party shall inform the applicable specifications (as established by mutual written agreement of the parties) by 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 other Party through the use of JSC and its Sub-Committees reasonably in advance about any plan to establish a mutually acceptable Third Party laboratory. Provisions will also be included that require supply relationship with any Gallium Salt API provided by Genta to conform to applicable specificationsnew contract manufacturer for Licensed Products or components thereof, and that provide for testing of upon such material for conformance information the Parties shall in good faith discuss and coordinate entering into a joint supply agreement with such specifications as well as for mechanisms for acceptance and rejection of such materials by Emisphere or its contract manufacturer. (iii) Provisions permitting Genta, its Affiliates and Sublicensees manufacture or have manufactured finished Product and the Program Carrier in . In the event of certain material performance failures by Emisphere. (iv) Provisions specifying a supply shortfall of a contract manufacturer that any failure to perform, or delay in performance, by Emisphere under the Supply Agreement that arises from Genta’s failure to supply Gallium Salt API as required to make Product within is at the time required under of such shortfall used by both Parties, the Supply AgreementParties shall, shall not be deemed to be a breach by Emisphere of through the Supply AgreementJSC and its Sub-Committees, [***].

Supply Agreement. Within ten (a10) Within * days after the Effective Date of this AgreementDate, the parties shall Parties will enter into a separate manufacturing and supply agreement in the form attached hereto as Exhibit C (the “Supply Agreement”) on reasonable 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 current and customary prospective sources to verify their ability to meet global quality standards. The Supply Agreement shall comply with the terms and conditions of this 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 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 controlManufacture of a full batch or batches of approximately ** unlabeled vials (per batch), and in any event consistent with terms summarized in this Section 8.2. (b) Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products and arrange storage at the Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect to the Program Carrier vendor’s facility at Servier’s expense if needed. Servier will be subject required to Genta’s prior approval, not to place orders with CTI and be unreasonably withheld, responsible for cancellation fees and that the terms of each subcontract agreement shall be reasonably consistent with all immediate reimbursement of the requirements and limitations imposed upon Emisphere under cost of the batch in accordance with the Supply Agreement. To 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 extent the Emisphere wishes Servier safety stock, which shall be allocated solely to itself manufacture the Products or Program Carriers (as opposed to using a subcontractorServier), then the parties will negotiate in good faith **, if any, shall be allocated between Servier and CTI ** of the terms of such a proposed arrangementLicensed Product over the ** period preceding the shortage. 9.2.4 Servier shall place an initial purchase order for **, 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 exceed any country-specific **. Genta ** covering the respective **. Such purchase orders in aggregate **. If ** are not available at the time of purchase order, CTI shall supply the Gallium Salt to Emisphere free of charge, 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) 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 orderssuch product **, and that otherwise, within ** if **. CTI shall invoice Servier for each Forecast will such ** order and such invoice shall 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 payable within ** 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 efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) in excess of * of the most recent estimate provided to Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the manufacture of Product pursuant to the Supply Agreementinvoice date by Servier. (ii) Provisions providing Genta with the right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by 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 use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform 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) Provisions 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 failure to supply Gallium Salt API as required to make Product within the time required under the Supply Agreement, shall not be deemed to be a breach by Emisphere of the Supply Agreement.