Common use of Manufacturing Clause in Contracts

Manufacturing. (a) Within sixty (60) days after the Effective Date, Cephalon (or its designee) and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject to the terms of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commission.

Manufacturing. In the event of any termination of this Agreement, to the extent COBI or any of its Affiliates or Sublicensees is engaged in the Manufacture of a Licensed Product as of the effective date of termination, COBI or such Affiliate or Sublicensee shall, as requested by AVEO, manufacture and supply AVEO’s requirements for such Licensed Product in the Field from the date of such termination until, with respect to each such Licensed Product, the earliest to occur of (ai) Within sixty such time as an alternative manufacturing source is manufacturing such Licensed Product for AVEO; (60ii) days [**] months after the Effective Date, Cephalon effective date of termination; or (or its designeeiii) and FBIO shall negotiate such time as AVEO provides written notice to COBI that AVEO is no longer in good faith to enter into a need of such manufacturing and supply agreement (the “Manufacturing and Supply Agreement”)support with respect to such Licensed Product; provided, pursuant that, with respect to which Cephalon shalleach Licensed Product, subject to the terms of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO AVEO shall use Commercially Reasonable Efforts to execute secure a satisfactory alternative manufacturing source as promptly as reasonably practicable following the effective date of termination and shall provide written notice to performCOBI as soon as such alternative source is secured and able to supply Licensed Product to AVEO. In the event of termination of this Agreement, COBI shall, at AVEO’s request, cooperate with AVEO, and cause the Third Party manufacturer of Licensed Product, if any, to, cooperate with AVEO, in the transfer, scale-up and validation of the manufacturing process for Licensed Product to AVEO or cause AVEO’s designee, including transfer of the master batch record and analytical methods and all other relevant records requested by AVEO related to production, testing and release of Licensed Product, and shall make its personnel reasonably available to AVEO to answer questions in connection with the foregoing. In the event COBI has terminated this Agreement under Section 9.3 or 9.4, the reasonable costs of COBI’s activities under this Section 9.5(c) shall be performed through borne by AVEO. In addition, at AVEO’s option, COBI shall use Commercially Reasonable Efforts to assign to AVEO any Third Party manufacturing contract relating to such Licensed Products to which COBI or any of its Affiliates and Sublicenseesis a party (or the applicable provisions thereof, as the Manufacturing activities assigned case may be). All Licensed Product supplied to it in AVEO by COBI pursuant to this Agreement and by Cephalon, and (iii) FBIO Section shall be solely responsible, at its cost and expense, for manufactured in compliance with then applicable current Good Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products Practices in and for the Field and the Territory in accordance which Licensed Product is intended for use and shall be sold by COBI, and purchased by AVEO, at a price equal to [**] percent ([**]%) of [**], provided that if COBI has terminated this Agreement under Section 9.3 or 9.4, the ▇▇▇▇-up shall be [**] percent ([**]%). At AVEO’s request in connection with Good Manufacturing Practice any supply relationship created under this Section, COBI and all applicable Laws AVEO shall execute a supply agreement with reasonable and standards. * Confidential material redacted customary provisions consistent with AVEO’s rights and filed separately with the CommissionCOBI’s obligations under this Agreement.

Manufacturing. (a) Within sixty (60) days after Subject to all of the Effective Dateterms and conditions of the License Agreement, Cephalon (or its designee) CBC shall be the exclusive master manufacturer for all Products for PlayBev to be sold in the Territory, as defined below. If and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject to the terms of extent that CBC does not perform the Manufacturing actual manufacturing itself, CBC will select and Supply Agreement, contract with vendors and subcontractors (i) Manufacture and supply (or have Manufactured and supplieda "Vendor") to FBIO *manufacture the Products as described below and will provide overall quality control, active pharmaceutical ingredient (“API”) logistics, management and drug product for Licensed Compounds administrative duties with respect to manufacturing as needed. PlayBev will not cause or Licensed Productspermit any Product not manufactured by or under the supervision of CBC to be imported, and (ii) conduct the Manufacturing development activities for Licensed Compounds sold or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and distributed in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed ProductsTerritory. (b) From The initial Products consist of an energy drink (tentatively called "Playboy Pure Energy Drink") and after flavored or unflavored water beverage (tentatively called "Playboy Water" or "Playboy H2O") (the "Initial Products"). The parties have determined that Vendors will be required for the following functions relating to the Initial Supply Term, Products: (i) FBIOidentification of key regional bottlers, at its own cost (ii) finalization of Product formulation and expenseproduction of sample / prototype Initial Products, (iii) production of prototype Initial Product packaging and bottling and conversion to production line packaging and bottling, (iv) supply chain management, and (v) subcontractor to identify and coordinate with Vendors under clauses (i) through (iv). PlayBev and, to the extent provided in the License Agreement, Playboy, shall have the right to approve all of such Vendors, which approval will not be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chainsunreasonably withheld or delayed. PlayBev may suggest entities or groups to serve as Vendor in any such capacity, and Manufacture CBC will consider such suggestions in good faith. CBC will contract directly with the Vendors and supply of on such pricing and payment terms as shall be negotiated directly between CBC and the Licensed Compounds Vendors. If and Licensed Products when CBC determines in the Field and its reasonable judgment that additional or different Vendors are required or desirable, it shall engage such additional Vendors, subject in the Territoryeach case to PlayBev's approval, which approval will not be unreasonably withheld or delayed. CBC may engage its affiliates as Vendors, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commissionapproval conditions described herein.

Manufacturing. Licensor shall have the obligation to, at its sole cost and expense, Manufacture and supply the Licensed Compound and Licensed Products necessary to complete the Development Activities in a manner consistent with the Development Plan, either itself or through one or more Affiliates or Third Parties selected by Licensor in its sole discretion; provided that (a) Within sixty any amendment of an existing supply arrangement with respect to the Licensed Compound or Licensed Products or (60b) days after any execution of any new supply agreement with respect to the Effective DateLicensed Compound or Licensed Products, Cephalon in each case ((a)-(b)), shall require AbbVie’s prior written consent. The Parties agree that any quantities of Licensed Compound or its designeeLicensed Product that (i) are manufactured pursuant to the Development Plan and FBIO (ii) are remaining following the completion of the Development Activities (other than the Late Phase Development Activities) shall be used for the Late Phase Development Activities, and if such remaining quantities of Licensed Compound or Licensed Product are no longer required to conduct Late Phase Development Activities, at AbbVie’s election, (x) such remaining quantities of Licensed Compound or Licensed Product shall be [†] or (y) the costs of such remaining quantities of Licensed Compound or Licensed Product shall be [†]. If AbbVie does not exercise the Option, the Parties shall negotiate in good faith Licensor’s repurchase of any Licensed Compound or Licensed Product [†], regardless of whether such inventory has been transferred to AbbVie. At AbbVie’s election, the Parties shall negotiate in good faith to enter into a manufacturing and separate form of supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject quality agreement with respect to the terms of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds Compound and Licensed Products in the Field Product from Licensor to AbbVie, which agreements shall contain reasonable and in the Territory, subject to the customary provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance consistent with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commissionindustry practice.

Manufacturing. (a) Within sixty (60) days after Lilly will manufacture, package, label, test, prepare for shipment and ship Marketed Product to ViroPharma from Lilly’s facilities, or the Effective Datefacilities of a Third Person under subcontract with Lilly, Cephalon (or its designee) at the times and FBIO shall negotiate in good faith to enter into the quantities set forth by ViroPharma in a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), purchase order pursuant to which Cephalon shallSection 4.5, subject subject, however, to the terms quantity restrictions set forth in Sections 4.1, 4.2 and 4.4. Each shipment of the Manufacturing and Supply Agreement, Marketed Product: (i) Manufacture and supply will have been manufactured in accordance with cGMP in effect at the time of manufacture, (ii) will not be adulterated or misbranded by Lilly within the meaning of the FDCA, (iii) will not have Manufactured and supplied) to FBIO *been manufactured, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds sold or Licensed Productsshipped in violation of any Applicable Laws in any material respect, and (iiiv) conduct upon delivery to ViroPharma, ex works, Lilly’s loading dock will convey good title to such Marketed Product to ViroPharma and such conveyance will be free and clear of any Encumbrance other than any Encumbrances created by ViroPharma. Lilly acknowledges and agrees that ViroPharma is under no obligation to purchase from Lilly any Marketed Product that does not meet the specifications and the representations and warranties set forth in this Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses Agreement. Lilly will fax (i) a certificate of analysis [***] 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. and/or a certificate of compliance confirming that such Marketed Product meets the Specifications then in effect, (ii) Lilly’s standard release documents and (ii)iii) as requested by FBIO and in the Territory for an initial period any other appropriate documentation, to be mutually agreed to upon by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in to ViroPharma no way restrict FBIO from contracting with Third Parties later than [***] after shipment of Marketed Product to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed ProductsViroPharma. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commission.

Manufacturing. (a) Within sixty (60) days after the Effective Date, Cephalon (or its designee) and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject to the terms of the Manufacturing and Supply Agreement, (i) 7.1. Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed ProductsSupply. Zai will be responsible for, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to performManufacture, or cause have Manufactured (pursuant to be performed through its Affiliates Section 2.4), Licensed Products, sufficient and Sublicensees, solely to meet the Manufacturing activities assigned to it Development and Commercialization requirements of a Licensed Product in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsiblethe Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with the Product Specifications. If [* * *], for Manufacturing Paratek will permit Paratek’s suppliers to provide such supply to Zai and supplying the worldwide requirements shall reasonably assist Zai to obtain a supply of Licensed Products for the Development and Commercialization activities contemplated hereunder by introducing Zai to suppliers that Paratek utilizes at that time. Zai will ensure that any arrangement between Zai and such suppliers (a) will not alter or affect Paratek’s supply related to the Licensed Product, and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the CFDA to Commercialize the Licensed Product as an imported product, the Parties will negotiate in good faith the terms of an agreement to address this event (an “Imported Product Agreement”), and such agreement will include, but not be limited to, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s involvement in the Development, Manufacture or Commercialization of the Licensed Compounds Product as an imported product, and Licensed Products Zai will maintain appropriate minimum liability insurance (to be determined in and for the Field and Imported Product Agreement) levels. For the avoidance of doubt, (y) Paratek will be adequately protected from any liability based on Zai’s activities in the Territory in accordance with Good Manufacturing Practice including Zai’s sourcing of the Compound or Licensed Product, and all applicable Laws and standards. * Confidential material redacted and filed separately with (z) absent the CommissionParties agreement to terms pursuant to an Imported Product Agreement, Paratek will not have any obligation to (i) accommodate the supply (directly or indirectly) of the Compound or Licensed Product to Zai, or (ii) be an applicant on a regulatory application or holder of a regulatory approval related to Zai’s Exploitation of the Licensed Product as an imported product.

Manufacturing. (a) Within sixty (60) days after Subject to all of the Effective Dateterms and conditions of the License Agreements, Cephalon (or its designee) LBC shall be the exclusive master manufacturer for all Products for GB to be sold in the Territory, as defined below. If and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject to the terms of extent that LBC does not perform the Manufacturing actual manufacturing itself, LBC will select and Supply Agreement, contract with vendors and subcontractors (i) Manufacture and supply (or have Manufactured and supplieda “Vendor”) to FBIO *manufacture the Products as described below and will provide overall quality control, active pharmaceutical ingredient (“API”) logistics, management and drug product for Licensed Compounds administrative duties with respect to manufacturing as needed. GB will not cause or Licensed Productspermit any Product not manufactured by or under the supervision of LBC to be imported, and (ii) conduct the Manufacturing development activities for Licensed Compounds sold or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and distributed in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed ProductsTerritory. (b) From The initial Products consist of an energy drink (tentatively called “HUSTLER Energy Drink”) in regular and after in sugar free versions and flavored or unflavored water beverage (tentatively called “HUSTLER Water” or “HUSTLER H2Oh”), condoms with different sizes and packages, Electronic ciggerattes, electronic cigars, cigars, hookas and hooka tobacco with HUSTLER brand (the “Initial Products”). The parties have determined that Vendors will be required for the following functions relating to the Initial Supply TermProducts: (i) identification of key regional bottlers for beverages and international manufacturers for condoms, cigars and e-cigarettes, (ii) finalization of Product formulation for the beverages, design and production of sample / prototypes Initial Products, (iii) production of prototype Initial Product packaging and bottling and conversion to production line packaging and bottling, (iv) supply chain management, and (v) subcontractor to identify and coordinate with Vendors under clauses (i) through (iv). GB and, to the extent provided in the License Agreements, HUSTLER, shall have the right to approve all of such Vendors, which approval will not be unreasonably withheld or delayed. GB may suggest entities or groups to serve as Vendor in any such capacity, and LBC will consider such suggestions in good faith. LBC will contract directly with the Vendors and on such pricing and payment terms as shall be negotiated directly between LBC and the Vendors. If and when LBC determines in its reasonable judgment that additional or different Vendors are required or desirable, it shall engage such additional Vendors, subject in each case to GB’s approval, which approval will not be unreasonably withheld or delayed. LBC may engage its affiliates as Vendors, subject to the approval conditions described herein. (c) As additional Products are developed, the parties shall similarly identify the Vendors which are required and LBC will engage the Vendors subject to GB’s approval. (d) LBC shall engage directly with all distributors and customers as the vendor of record and negotiate all payment terms directly. As vendor of record, all payments for the Product will be made directly to LBC. All pricing terms shall be approved by GB in advance in writing, which approval shall not be unreasonably withheld or delayed. (e) GB will use its best efforts to have LBC and, to the extent required, its Vendors approved as manufacturers under the HUSTLER licenses. If a Vendor is required to be approved but HUSTLER does not approve the Vendor, LBC will engage an alternative Vendor, subject to GB’s approval as set forth above. If LBC is not approved by HUSTLER, then notwithstanding Sections 1 (a) through (d) above, (i) FBIOthe Vendors will contract directly with GB, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chainsrather than LBC, and Manufacture and supply of LBC shall assign to GB any then-existing contracts with the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b)Vendors, (ii) FBIO the roles of LBC and GB in selecting and approving Vendors described in Sections 1(b) and (c) shall use Commercially Reasonable Efforts be reversed, (iii) LBC shall remain as the vendor of record to execute customers and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalondistributors, and (iiiiv) FBIO LBC shall supervise the manufacturers and other Vendors approved by HUSTLER. (f) LBC will be solely responsible, at compensated for its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products services pursuant to this Section 1 as described in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the CommissionSection 3.

Manufacturing. (a) Within sixty Subject to the oversight of the Supply Chain Committee as described in Section 2.7, BMS or its Affiliates shall manufacture (60bulk, fill and finish) each Product, or BMS shall arrange to have such Product manufactured by a Third Party or COLLABORATOR in accordance with the terms hereof, including both clinical supplies and commercial quantities. The Supply Chain Committee shall prepare and submit to the CFDT or JCC, as applicable, for its approval, a proposed Supply Chain Management plan for each Product designed to provide reasonable assurance that the Parties are able to satisfy the forecasted demand for clinical and commercial quantities (including Samples) of such Product (a “Supply Plan”). Such Supply Plan shall include (i) a plan for producing Launch quantities for each finished Product, including appropriate inventory and safety stock levels and (ii) monthly replenishment schedules reflecting production planning demand over a [*] forecast of unit volume and inventory of each SKU of each Product for each country. The Supply Plan shall not include any provisions that conflict or are inconsistent with BMS’s standard operating procedures for manufacturing. The Supply Chain Committee shall prepare and submit to the CFDT or JCC, as applicable, the Supply Plan for the Initial Product promptly after the receipt of the initial forecasts provided for below from the CFDT [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. or Regional Operating Committees, as applicable, and shall prepare and submit to the CFDT or JCC, as applicable, promptly after the inclusion in the Collaboration of any New Collaboration Compound or any other Product and the receipt of the initial forecasts with respect thereto the Supply Plan for such New Collaboration Compound or Product. On a Quarterly basis after the approval of the initial Supply Plan for a Product, the Supply Chain Committee shall prepare and submit to the CFDT or JCC, as applicable, for its approval, an update of such Supply Plan to take into account changes in forecasted demand for clinical and commercial quantities of the Initial Product consistent with the limitations on allowable variations in forecasts provided for in Exhibit N. During the period that is more than eighteen (18) months prior to the anticipated Regulatory Approval of a Product, the CFDT shall prepare and provide to BMS and the Supply Chain Committee not later than the first day of each Quarter a [*] written unit volume forecast of the Collaboration’s requirements of each SKU of each Product for each Region consistent with Exhibit N. Commencing [*] prior to the anticipated Regulatory Approval of a Product, the CFDT or, upon the transition of forecasting functions to the Regional Operating Committees, each Regional Operating Committee shall prepare and provide to BMS and the Supply Chain Committee not later than the first day of each month a [*] written unit volume forecast of the Collaboration’s requirements of each SKU of each Product for each country consistent with Exhibit N (each such [*] forecast being referred to herein as a “Detailed Forecast”). Promptly following the formation of the CFDT and in any event not later than forty-five (45) days after following the Effective Execution Date, Cephalon the CFDT shall prepare and provide to BMS a good faith ten-year rolling product planning forecast of the Collaboration’s requirements of each Product (and each SKU if known) for each Region or its designeecountry (as provided above with respect to the Detailed Forecast) for each year in such ten-year forecast consistent with Exhibit N (the “Long-Range Forecast”), which shall be the CFDT’s best good faith estimates of such requirements. The first [*] of such Long-Range Forecast shall be consistent with the Detailed Forecast. Such Long-Range Forecast shall be updated semi-annually by the CFDT or ROCS, as applicable, and FBIO supplied to BMS not later than January 1 and July 1 of each Year. Each periodic update of the Supply Plan shall be consistent with such forecasts and consistent with the limitations on allowable variations in forecasts provided for in Exhibit N. [*]. The limitations set forth in Exhibit N on allowable variations in successive forecasts and BMS’s supply obligations with respect to the Forecasted Amount are based on the assumption that lead times for starting materials and outsourced intermediates are [*] months or less and are subject to modification, as necessary, to reflect lead times longer than [*] months. In the event the actual or expected lead times for any starting material or intermediates will exceed [*] months, BMS shall notify the Supply Chain Committee, and the Parties shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant establish appropriate adjustments to which Cephalon shall, subject to the terms of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Productssuch limitations. (b) From BMS shall supply (or cause Third Parties to supply consistent with this Agreement) such quantities of each Product as are set forth in the then current Supply Plan for such Product (the “Forecasted Amount”) in the month set forth therein; provided that such amounts are consistent with the forecasting procedures and after the Initial Supply Termlimitation on allowable variations in forecasts provided for in Exhibit N, (i) FBIO, at its own cost and expense, but BMS shall not be responsible for all Manufacturing development, establishment in breach of Manufacturing sources and this Agreement as a result of any failure to supply chains, and Manufacture and supply any amounts in excess of the Licensed Compounds and Licensed Products Forecasted Amount. If in any month BMS breaches its supply obligations set forth in the Field and in the Territory, subject to the provisions first sentence of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts paragraph with respect to execute and any [*] = Portions of this exhibit have been omitted pursuant to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in a confidential treatment request. An unredacted version of this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and exhibit has been filed separately with the Securities and Exchange Commission. Product, [*]. The Parties agree that in the event of any termination by COLLABORATOR as the result of any breach of BMS’s supply obligation, this Section 6.1(b), COLLABORATOR’s right of termination, if applicable, and if such right is exercised, Section 11.11 and the royalties provided for therein are COLLABORATOR’s sole and exclusive remedy for BMS’s breach of this Section 6.1(b). Any amounts paid or payable by BMS pursuant to the second sentence of this Section 6.1(b) shall not be included in Manufacturing Costs, Development Costs or Allowable Expenses. (c) In the event that sufficient quantities of any Product are not available to satisfy the Forecasted Amount in the Territory and BMS’s or the Japan Licensee’s (if applicable) requirements for the Product outside the Territory, BMS shall allocate all available quantities of such Product to the Territory and to Japan (if Japan is outside the Territory) and any Terminated Territory on a pro-rata basis based on the then current patient demand for the Product in the Territory and Japan (if Japan is outside the Territory) and the Terminated Territory.

Manufacturing. (a) Within sixty (60Subject to Section 3.1.3(b) days after below, Gen-Probe shall have the Effective Date, Cephalon exclusive right and the obligation to manufacture (or its designeeto have manufactured) and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject to the terms Chiron with its requirements of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and Initial Blood Screening Assays in the Territory for an initial period to be agreed to by use in the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall Blood Screening Field in no way restrict FBIO from contracting accordance with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed ProductsArticle 6 below. (b) From and after the Initial Supply Term, If Gen-Probe (i) FBIO, fails at its own cost and expense, any time during the Blood Screening Term to maintain the applicable FDA (CBER) license for the facility used to manufacture an Initial Blood Screening Assay (unless Gen-Probe is approved by CBER to manufacture from an alternate location or the Supervisory Board agrees within fifteen days of such event that Gen-Probe shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of retain the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(bmanufacturing responsibility hereunder), ; or (ii) FBIO fails to supply Chiron within [***] after the requested delivery date with Chiron's monthly requirements for an Initial Blood Screening Assay ordered in accordance with Section 6.3 below, for any [***] (unless the Supervisory Board agrees within fifteen days of such event that Gen-Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the right to, and if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to execute and to performhave manufactured) its requirements of such Initial Blood Screening Assay, or cause to be performed through its Affiliates and Sublicenseesconducted by the Blood Screening Instruments in the Territory for use in the Blood Screening Field; provided, the Manufacturing activities assigned to it in this Agreement and by Cephalonhowever, and (iii) FBIO such right of Chiron shall be solely responsible, at its cost on an assay-by-assay basis for a failure to supply and expense, for Manufacturing and supplying provided further that to the worldwide extent Gen-Probe is able to meet Chiron's requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory Rare Reagents in accordance with Good Manufacturing Practice this agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and all applicable Laws the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Initial Blood Screening Assay in accordance with Article 6 below. In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and standards. responsibility for the facility used by Gen-Probe to manufacture the Initial Blood Screening Assays, and Gen-Probe promptly shall provide such *** Confidential material redacted Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Initial Blood Screening Assay. (c) If either party exercises any right granted hereunder to have any Initial Blood Screening Assay manufactured, then (i) such party shall first require that the subcontracted party shall enter into a confidentiality agreement with such party incorporating the terms of Article 8 below; (ii) such party shall supervise such subcontract work; (iii) the subcontracted party shall comply in all material respects with all requirements of applicable laws and regulations, together with all applicable good laboratory, clinical and manufacturing practices; and (iv) the subcontracted party shall enter into an agreement with such party to the extent necessary to effectuate the provisions of Article 9 below.

Manufacturing. 3.1. Subject to the remainder of this Section 3 (aManufacturing), FCDI shall have the right to negotiate to act as Licensee’s exclusive manufacturer and supplier of iPSC Line(s) Within sixty for Licensee and to act as the principal external manufacturer for (60i) days after the Effective DateLicensed Products for Licensee, Cephalon including Limited Manufacturing that is in preparation for pre-clinical studies or Clinical Activities and (ii) for commercial supply of all Specified Products for which Licensee or its designeePermitted Sublicensee shall decide to use a contract manufacturer, including Clinical Activities that are commercial scale manufacturing. For clarity, Licensee or its Permitted Sublicensee has the right to manufacture any and all Licensed Products or Specified Products on its own without any requirement to negotiate with FCDI hereunder. In accordance with the preceding provision, Licensee shall not, and shall require its Permitted Sublicensees to not, enter into any definitive agreement whereby a Third Party would manufacture or supply iPSC Line(s) and FBIO Licensed Products to Licensee or any of its Permitted Sublicensee unless Licensee or its Permitted Sublicensee shall negotiate in good faith have first given written notice of its intention to enter into a manufacturing contract manufacture or supply arrangement to FCDI and negotiated in good faith with FCDI regarding the terms and conditions of such manufacture or supply agreement (arrangement for a period of at least [***] from the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject date of Licensee’s notice. Notwithstanding anything to the terms of contrary, the Manufacturing and Supply Agreement, foregoing negotiation right shall only apply to those manufacturing activities for which FCDI has (i) Manufacture reasonably demonstrated to have commercial experience and supply capabilities (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment including of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(bcGMP capabilities), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause reasonably demonstrated to be performed through its Affiliates in compliance with applicable FDA and SublicenseesEMEA requirements relating to cGMP manufacturing, including compliance with EudraLex Volume 4 (“The rules governing medicinal products in the Manufacturing activities assigned to it in this Agreement and by CephalonEuropean Union”), and (iii) FBIO shall be solely responsibleavailable capacity that meets the needs of Licensee’s program timelines. By way of example and not limitation, at FCDI and/or its cost Affiliate(s) may reasonably demonstrate such commercial experience and expensecapabilities, for Manufacturing and supplying the worldwide compliance with such applicable requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance relating to cGMP manufacturing and/or capacity based on its manufacturing activities with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commissionrespect to any iPSC-derived cell type.

Manufacturing. (a) Within sixty (60) days after During the Effective DateTerm, Cephalon (or its designeeBaxter shall manufacture for Newco the Manufactured Products, and shall complete the manufacturing and assembly of the Isolex(R) and FBIO shall negotiate in good faith Maxsep(R) instruments and disposable sets using components to enter into a manufacturing be acquired by Newco from third parties or supplied by Baxter under the Hardware and supply agreement (Disposables Supply Agreement and the “Antibody Manufacturing and Supply Storage Agreement”), pursuant to which Cephalon shallfor use and sale in the Product Field, subject to the terms of the Manufacturing and Supply conditions contained in this Agreement, (i) Manufacture and supply (or have . In manufacturing such Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”)Baxter will produce finished goods. Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products. (b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it Nothing contained in this Agreement shall prevent Newco from having products with the same specifications as the Manufactured Products manufactured by Newco or third parties on behalf of Newco. Nothing herein contained shall oblige Baxter to continue producing or Newco to continue purchasing any Manufactured Product if such production is reasonably believed by Baxter or by Newco, as the case may be, to violate any applicable law, regulation, rule or license or if the Manufactured Products produced infringe a third party's patent or other intellectual property rights, provided that -------- Baxter will cooperate with Newco, to the extent commercially feasible, to develop and by Cephalonimplement such changes as may be necessary to bring a Manufactured Product into compliance or to prevent such infringement, and (iiiBaxter will continue to produce after a finding of infringement if Newco reaches an agreement with the third party which permits future production without infringement. Proposed new products identified on Schedule 1 as Isolex(R) FBIO and Maxsep(R) Products and manufactured by Baxter pursuant to the Services Agreement shall become Manufactured Products and shall be solely responsiblemanufactured by Baxter hereunder in the event that, and at such time as, their specifications become sufficiently fixed to permit standardized production at commercial levels. In the event that Baxter, in its cost sole discretion, agrees to manufacture for Newco any other instruments, disposable sets or other products (other than proposed new products identified on Schedule 1 as Isolex(R) and expenseMaxsep(R) Products agreed to be manufactured as Manufactured Products hereunder), and Baxter and Newco enter into a separate written agreement on mutually agreeable terms (including price) with respect to such manufacturing, then Baxter will manufacture such additional products as the two parties may so agree, and such additional products will be treated for Manufacturing and supplying the worldwide requirements for the Development and Commercialization all purposes of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commissionthis Agreement as Manufactured Products.