Common use of Manufacturing Clause in Contracts

Manufacturing. (a) Fortis will use its existing inventory of Products as of the Effective Date (“Existing Inventory”) to supply all Products necessary to conduct the Fortis Clinical Studies and for any other purposes set forth in the Study Plan that is to be supplied from the Existing Inventory. Fortis will not use the Existing Inventory for any other purpose unless approved by the JSC. To the extent that the Existing Inventory is insufficient for the requirements of the Fortis Clinical Studies or any other Study Plan activities meant to be supplied from the Existing Inventory, then FibroGen will be responsible for supplying any additional Products required to meet such outstanding requirement (“Fortis Additional Product Requirement”) at its cost. (b) Within [*], the Parties will meet in good faith to discuss the establishment of a Third Party supply of Products to FibroGen meeting any quantity and quality requirements of the applicable Study Plan activities, meeting the necessary timeframe required by the Study Plan, and on commercially reasonable terms (whether using Fortis’s existing supplier of Products or another Third Party supplier) (“Third Party Source”). The Parties will use Commercially Reasonable Efforts to cooperate and establish a Third Party Source to FibroGen within the timelines and in the quantities set forth in the Study Plan, which efforts by Fortis will include, solely if requested by FibroGen: (i) Fortis entering into an amendment to one or more supply agreements [*] to permit FibroGen to order, and to oversee and authorize all aspects of CMC (including Manufacturing) with respect to, such Products or related components, packaging or labeling, as applicable, under such supply agreements, in order to meet FibroGen’s obligations under this Agreement [*], provided that [*] to meet FibroGen’s obligations under this Agreement, at FibroGen’s [*]. (c) FibroGen will be responsible for the supply of any Products necessary for the FibroGen Clinical Studies, any Evaluation Activities under the Study Plan and the Fortis Additional Product Requirements, at its cost. All Products supplied by FibroGen pursuant to Fortis Additional Product Requirements (i) shall be manufactured in accordance with GMP and applicable specifications for such Products, shall not be adulterated or misbranded, and shall be free and clear of any liens or encumbrances, and (ii) shall otherwise comply with any quality agreement that the Parties may enter into with respect to the Products. (d) Fortis will use [*] to cause COI to assign the COI STA Agreement to Fortis [*].

Manufacturing. (a) Fortis 4.1 Lilly will use its existing inventory manufacture final Product(s). Emisphere will manufacture at least [***] % of the Carrier needed for Product sales. Lilly will pay Emisphere the latter's [***] on all Carrier used for sales of Products as of less than or equal to the Effective Date (“Existing Inventory”) to supply all Products necessary to conduct the Fortis Clinical Studies and for any other purposes sales schedule set forth in the Study Plan relevant Appendix to the Option Agreement. Above the Product sales level specified in the relevant Appendix of the Option Agreement, Lilly will pay Emisphere's direct manufacturing costs (calculated according to the [***] . Lilly will be permitted to manufacture up to [***] % of the Carrier needed to manufacture the Products. If Lilly can find a Carrier source that can offer a supply price that is at least [***] % lower than Emisphere's supply price (including Lilly, with supply price in such case being [***] [***] , all determined in accordance with GAAP principles), Lilly may use such supplier for up to [***] % of the Carrier needed to manufacture the Product. So long as Lilly uses it as a supplier of Carrier, Emisphere will hold at minimum [***] [***] of Carrier inventory per year to be supplied from determined at the Existing Inventoryappropriate time. Fortis will not use the Existing Inventory for any other purpose unless approved by the JSC. To the extent that the Existing Inventory is insufficient for the requirements of the Fortis Clinical Studies or any other Study Plan activities meant to be supplied from the Existing Inventory, then FibroGen will be responsible for supplying any additional Products required to meet such outstanding requirement (“Fortis Additional Product Requirement”) at its cost. (b) Within [*], the Parties Emisphere's manufacturing operations will meet in good faith to discuss the establishment of a Third Party supply of Products to FibroGen meeting any quantity and quality requirements of the applicable Study Plan activitiesrequired regulatory agency's specifications for registration, meeting the necessary timeframe required by the Study Plan, and on commercially reasonable terms (whether using Fortis’s existing supplier of Products or another Third Party supplier) (“Third Party Source”). The Parties will use Commercially Reasonable Efforts to cooperate and establish a Third Party Source to FibroGen within the timelines and in the quantities as set forth in the Study Plan, which efforts by Fortis will include, solely if requested by FibroGen: (i) Fortis entering into an amendment to one or more supply agreements [***] . 4.2 Lilly shall be permitted to permit FibroGen produce Carrier for its use in clinical trials, but only until Emisphere is able to ordersupply the Carrier pursuant to the terms of Section 4.1. 4.3 Lilly reserves the right to audit the facility of Emisphere as specified in the [***] , including its processes, records, and other facets of the operation as may be necessary to oversee assure that all applicable FDA or similar government regulations have been met. Emisphere shall permit duly authorized representatives of Lilly to audit all research, development and authorize manufacturing areas and operations as they apply to Emisphere projects or Carriers for Lilly at reasonable times with a prior appointment. The right to audit will also apply to Carrier used in trials to support product registration. These audits will be conducted to assure compliance with all aspects pertinent acts, regulations, and guidelines promulgated by the FDA and other regulatory authorities. Such audits will be permitted during normal business hours and will be performed with a minimum of CMC (including Manufacturing) with respect to, such Products or related components, packaging or labeling, disruption. Lilly shall furnish to Emisphere copies of all reports prepared as applicable, under such supply agreements, in order a result of these audits. Lilly agrees to meet FibroGen’s obligations under this Agreement notify Emisphere within [*], provided that [**] to meet FibroGen’s obligations under this Agreement, at FibroGen’s [*]. (c) FibroGen will be responsible for the supply of any Products necessary for concerns that it may have regarding Carrier(s). Lilly will also have the FibroGen Clinical Studies, any Evaluation Activities under the Study Plan and the Fortis Additional Product Requirements, at its cost. All Products supplied by FibroGen pursuant right to Fortis Additional Product Requirements (i) shall be manufactured audit Emisphere's financial manufacturing records in accordance with GMP and applicable specifications for such Products, shall not be adulterated or misbranded, and shall be free and clear of any liens or encumbrances, and (ii) shall otherwise comply with any quality agreement that the Parties may enter into with respect to the ProductsClause 9.2. (d) Fortis will use [*] to cause COI to assign the COI STA Agreement to Fortis [*].

Manufacturing. (a) Fortis 4.1 Lilly will use its existing inventory manufacture final Product(s). Emisphere will manufacture at least [* * *] of the Carrier needed for Product sales. Lilly will pay Emisphere the latter's [* * *] on all Carrier used for sales of Products as of less than or equal to the Effective Date (“Existing Inventory”) to supply all Products necessary to conduct the Fortis Clinical Studies and for any other purposes sales schedule set forth in the Study Plan relevant Appendix to the Option Agreement. Above the Product sales level specified in the relevant Appendix of the Option Agreement, Lilly will pay Emisphere's direct manufacturing costs (calculated according to the [* * *]. Lilly will be permitted to manufacture up to [* * *]% of the Carrier needed to manufacture the Products. If Lilly can find a Carrier source that can offer a supply price that is at least [* * *]% lower than Emisphere's supply price (including Lilly, with supply price in such case being [* * *] all determined in accordance with GAAP principles), Lilly may use such supplier for up to [* * *]% of the Carrier needed to manufacture the Product. So long as Lilly uses it as a supplier of Carrier, Emisphere will hold at minimum [* * *] of Carrier inventory per year to be supplied from determined at the Existing Inventoryappropriate time. Fortis will not use the Existing Inventory for any other purpose unless approved by the JSC. To the extent that the Existing Inventory is insufficient for the requirements of the Fortis Clinical Studies or any other Study Plan activities meant to be supplied from the Existing Inventory, then FibroGen will be responsible for supplying any additional Products required to meet such outstanding requirement (“Fortis Additional Product Requirement”) at its cost. (b) Within [*], the Parties Emisphere's manufacturing operations will meet in good faith to discuss the establishment of a Third Party supply of Products to FibroGen meeting any quantity and quality requirements of the applicable Study Plan activitiesrequired regulatory agency's specifications for registration, meeting the necessary timeframe required by the Study Plan, and on commercially reasonable terms (whether using Fortis’s existing supplier of Products or another Third Party supplier) (“Third Party Source”). The Parties will use Commercially Reasonable Efforts to cooperate and establish a Third Party Source to FibroGen within the timelines and in the quantities as set forth in the Study Plan[* * *]. Confidentiality Requested by Emisphere Technologies, which efforts by Fortis will includeInc. SEC File No. 1-10615 4.2 Lilly shall be permitted to produce Carrier for its use in clinical trials, solely if requested by FibroGen: (i) Fortis entering into an amendment but only until Emisphere is able to one or more supply agreements the Carrier pursuant to the terms of Section 4.1. 4.3 Lilly reserves the right to audit the facility of Emisphere as specified in the [*] to permit FibroGen to order, and to oversee and authorize all aspects of CMC (including Manufacturing) with respect to, such Products or related components, packaging or labeling, as applicable, under such supply agreements, in order to meet FibroGen’s obligations under this Agreement [* * *], provided including its processes, records, and other facets of the operation as may be necessary to assure that all applicable FDA or similar government regulations have been met. Emisphere shall permit duly authorized representatives of Lilly to audit all research, development and manufacturing areas and operations as they apply to Emisphere projects or Carriers for Lilly at reasonable times with a prior appointment. The right to audit will also apply to Carrier used in trials to support product registration. These audits will be conducted to assure compliance with all pertinent acts, regulations, and guidelines promulgated by the FDA and other regulatory authorities. Such audits will be permitted during normal business hours and will be performed with a minimum of disruption. Lilly shall furnish to Emisphere copies of all reports prepared as a result of these audits. Lilly agrees to notify Emisphere within [* * *] to meet FibroGen’s obligations under this Agreement, at FibroGen’s [*]. (c) FibroGen will be responsible for the supply of any Products necessary for concerns that it may have regarding Carrier(s). Lilly will also have the FibroGen Clinical Studies, any Evaluation Activities under the Study Plan and the Fortis Additional Product Requirements, at its cost. All Products supplied by FibroGen pursuant right to Fortis Additional Product Requirements (i) shall be manufactured audit Emisphere's financial manufacturing records in accordance with GMP and applicable specifications for such Products, shall not be adulterated or misbranded, and shall be free and clear of any liens or encumbrances, and (ii) shall otherwise comply with any quality agreement that the Parties may enter into with respect to the ProductsClause 9.2. (d) Fortis will use [*] to cause COI to assign the COI STA Agreement to Fortis [*].

Manufacturing. All manufacturing of Ivory for all indications and uses in accordance with applicable product specifications and GMP, including labeling, fill/finish, packaging, selection of presentations and manufacturing-related regulatory activities (aincluding regulatory inspections). GSK will have the right to audit Amgen’s manufacturing facilities and any Third Party manufacturing facilities used for the manufacture of Ivory in the Collaboration Scope on a periodic basis, not to exceed once every eighteen (18) Fortis will use its existing inventory of Products as of the Effective Date months for routine audits (“Existing InventoryRoutine Audits”) or as defined below with respect to supply for-cause audits (“For Cause Audits”) (provided such request is made within sixty (60) days of GSK being informed of or becoming aware of an event that would permit a For Cause Audit in GSK’s reasonable opinion). GSK will bear the cost of all Products necessary Routine Audits and For Cause Audits of Amgen manufacturing facilities conducted by GSK and such costs will not be subject to cost-sharing between the Parties under this Agreement. The costs of any Routine Audits and For Cause Audits of any Third Party manufacturing facility requested by GSK will be included in GSK Costs and will be subject to the cost-sharing principles under this Agreement, unless otherwise provided below. GSK will notify Amgen in writing if GSK desires to conduct any manufacturing audit, and the Fortis Clinical Studies Parties will mutually agree upon reasonable audit agendas in advance and for any other purposes set forth reasonably cooperate in the Study Plan conduct of such audit. If GSK notifies Amgen that is GSK desires to be supplied from conduct either a For Cause Audit or Routine Audit of a Third Party manufacturer, Amgen will notify GSK if Amgen’s contract with such Third Party manufacturer permits GSK to conduct such audit, in which case Amgen will allow GSK to conduct such audit (with Amgen’s participation, if it chooses). If Amgen’s contract with such Third Party manufacturer does not permit GSK to conduct audits, then Amgen will conduct such audit and share the Existing Inventory. Fortis will not use the Existing Inventory for any other purpose unless approved by the JSC. To results with GSK to the extent that permitted under Amgen’s contract with such Third Party manufacturer. Notwithstanding the Existing Inventory is insufficient for the requirements of the Fortis Clinical Studies or any other Study Plan activities meant to be supplied from the Existing Inventory, then FibroGen will be responsible for supplying any additional Products required to meet such outstanding requirement (“Fortis Additional Product Requirement”) at its cost. (b) Within [*]foregoing, the Parties will meet in good faith cooperate to discuss the establishment coordinate and achieve reasonable efficiencies with respect to audits of Third Party manufacturers as follows: (i) if GSK requests a Routine Audit of a Third Party supply manufacturer, and Amgen has conducted a Routine Audit of Products such manufacturer in the previous eighteen (18) months, then Amgen will share with GSK the results of any Routine Audit of such Third Party (to FibroGen meeting any quantity and quality requirements the extent permitted under Amgen’s contract with such Third Party manufacturer), (ii) if after sharing the results described under (i), GSK would like to proceed with a Routine Audit of such Third Party, then, to the extent permitted under Amgen’s contract with such Third Party manufacturer, GSK may conduct such Routine Audit (or, to the extent permitted under Amgen’s contract with such Third Party manufacturer, Amgen will conduct such Routine Audit if GSK is not permitted to do so under the applicable Study Plan activities, meeting the necessary timeframe required by the Study Plan, and on commercially reasonable terms (whether using Fortis’s existing supplier of Products or another Third Party suppliermanufacturing contract) (“Third Party Source”)and the costs of such Routine Audit will be borne by GSK and will not be subject to cost-sharing under this Agreement. The Parties will use Commercially Reasonable Efforts to cooperate and establish Any audit of a Third Party Source manufacturer will be subject to FibroGen within the timelines terms and conditions of Amgen’s contract(s) with such manufacturer and GSK will cooperate and coordinate with Amgen to comply with all reasonable terms and conditions communicated by Amgen in connection with the performance of such audit. Any audit of an Amgen manufacturing facility will comply with Amgen’s reasonable policies and procedures. GSK’s Routine Audits will be limited in scope to what is reasonably necessary to confirm that Amgen or a Third Party manufacturer has complied with all applicable product specifications, GMP or GDP requirements in manufacturing Ivory. GSK’s For Cause Audits will be limited in scope to what is reasonably necessary to confirm that the cause for such audit has been or is being remedied. Any information disclosed to GSK in the quantities set forth in course of any audit may only be used for the Study Plan, which efforts by Fortis will include, solely if requested by FibroGen: (i) Fortis entering into an amendment to one or more supply agreements [*] to permit FibroGen to order, and to oversee and authorize all aspects purposes of CMC (including Manufacturing) with respect to, such Products or related components, packaging or labeling, as applicable, under such supply agreements, in order to meet FibroGen’s obligations under this Agreement [*], provided that [*] to meet FibroGen’s obligations audit. Any audit conducted under this Agreement, at FibroGen’s [*]. the Expansion Agreement or the relevant Ivory supply agreement between Amgen and GSK will be considered an audit conducted under all such agreements. For the purposes of this Section 3.14.4 (Manufacturing), the following will give GSK the right to conduct a For Cause Audit: (a) receipt of a warning letter pertaining to manufacturing concerns or issues for Ivory from the relevant Governmental Agency; (b) a recall of Ivory in the Collaboration Scope based on manufacturing concerns or issues; (c) FibroGen will be responsible product complaints evidencing material manufacturing concerns or issues for the supply of any Products necessary for the FibroGen Clinical Studies, any Evaluation Activities under the Study Plan Ivory; and the Fortis Additional Product Requirements, at its cost. All Products supplied by FibroGen pursuant to Fortis Additional Product Requirements (i) shall be manufactured in accordance with GMP and applicable specifications for such Products, shall not be adulterated or misbranded, and shall be free and clear of any liens or encumbrances, and (ii) shall otherwise comply with any quality agreement that the Parties may enter into with respect to the Products. (d) Fortis more than one (1) lot failure or stability failure of Ivory in any calendar year that indicates a likely manufacturing concern or issue. The JSC will use [*] review events that may give rise to cause COI the right to assign the COI STA Agreement to Fortis [*]conduct a For Cause Audit if so requested by either Party.

Manufacturing. All manufacturing of Ivory for all indications and uses in accordance with applicable product specifications and GMP, including labeling, fill/finish, packaging, selection of presentations and manufacturing-related regulatory activities (aincluding regulatory inspections). GSK will have the right to audit Amgen’s manufacturing facilities and any Third Party manufacturing facilities used for the manufacture of Ivory in the Collaboration Scope on a periodic basis, not to exceed once every eighteen (18) Fortis will use its existing inventory of Products as of the Effective Date months for routine audits (“Existing InventoryRoutine Audits”) or as defined below with respect to supply for-cause audits (“For Cause Audits”) (provided such request is made within sixty (60) days of GSK being informed of or becoming aware of an event that would permit a For Cause Audit in GSK’s reasonable opinion). GSK will bear the cost of all Products necessary Routine Audits and For Cause Audits of Amgen manufacturing facilities conducted by GSK and such costs will not be subject to cost-sharing between the Parties under this Agreement. The costs of any Routine Audits and For Cause Audits of any Third Party manufacturing facility requested by GSK will be included in GSK Costs and will be subject to the cost-sharing principles under this Agreement, unless otherwise provided below. GSK will notify Amgen in writing if GSK desires to conduct any manufacturing audit, and the Fortis Clinical Studies Parties will mutually agree upon reasonable audit agendas in advance and for any other purposes set forth reasonably cooperate in the Study Plan conduct of such audit. If GSK notifies Amgen that is GSK desires to be supplied from conduct either a For Cause Audit or Routine Audit of a Third Party manufacturer, Amgen will notify GSK if Amgen’s contract with such Third Party manufacturer permits GSK to conduct such audit, in which case Amgen will allow GSK to conduct such audit (with Amgen’s participation, if it chooses). If Amgen’s contract with such Third Party manufacturer does not permit GSK to conduct audits, then Amgen will conduct such audit and share the Existing Inventory. Fortis will not use the Existing Inventory for any other purpose unless approved by the JSC. To results with GSK to the extent that permitted under Amgen’s contract with such Third Party manufacturer. Notwithstanding the Existing Inventory is insufficient for foregoing, the requirements Parties will cooperate to coordinate and achieve reasonable efficiencies with respect to audits of Third Party manufacturers as follows: (i) if GSK requests a Routine Audit of a Third Party manufacturer, and Amgen has conducted a Routine Audit of such manufacturer in the Fortis Clinical Studies or any other Study Plan activities meant to be supplied from the Existing Inventory, then FibroGen will be responsible for supplying any additional Products required to meet such outstanding requirement (“Fortis Additional Product Requirement”) at its cost. (b) Within previous [*], then Amgen will share with GSK the Parties results of any Routine Audit of such Third Party (to the extent permitted under Amgen’s contract with such Third Party manufacturer), (ii) if after sharing the results described under (i), GSK would like to proceed with a Routine Audit of such Third Party, then, to the extent permitted under Amgen’s contract with such Third Party manufacturer, GSK may conduct such Routine Audit (or, to the extent permitted under Amgen’s contract with such Third Party manufacturer, Amgen will meet in good faith conduct such Routine Audit if GSK is not permitted to discuss do so under the establishment applicable Third Party manufacturing contract) and the costs of such Routine Audit will be borne by GSK and will not be subject to cost-sharing under this Agreement. Any audit of a Third Party supply manufacturer will be subject to the terms and conditions of Products Amgen’s contract(s) with such manufacturer and GSK will cooperate and coordinate with Amgen to FibroGen meeting any quantity and quality requirements of the applicable Study Plan activities, meeting the necessary timeframe required by the Study Plan, and on commercially comply with all reasonable terms (whether using Fortisand conditions communicated by Amgen in connection with the performance of such audit. Any audit of an Amgen manufacturing facility will comply with Amgen’s existing supplier of Products reasonable policies and procedures. GSK’s Routine Audits will be limited in scope to what is reasonably necessary to confirm that Amgen or another Third Party supplier) (“Third Party Source”). The Parties will use Commercially Reasonable Efforts to cooperate and establish a Third Party Source manufacturer has complied with all applicable product specifications, GMP or GDP requirements in manufacturing Ivory. GSK’s For Cause Audits will be limited in scope to FibroGen within what is reasonably necessary to confirm that the timelines and cause for such audit has been or is being remedied. Any information disclosed to GSK in the quantities set forth in course of any audit may only be used for the Study Plan, which efforts by Fortis will include, solely if requested by FibroGen: (i) Fortis entering into an amendment to one or more supply agreements [*] to permit FibroGen to order, and to oversee and authorize all aspects purposes of CMC (including Manufacturing) with respect to, such Products or related components, packaging or labeling, as applicable, under such supply agreements, in order to meet FibroGen’s obligations under this Agreement [*], provided that [*] to meet FibroGen’s obligations audit. Any audit conducted under this Agreement, at FibroGen’s the Expansion Agreement or the relevant Ivory supply agreement between Amgen and GSK will be considered an audit conducted under all such agreements. For the purposes of this Section 3.14.4 (Manufacturing), the following will give GSK the right to conduct a For Cause Audit: [*]. (c) FibroGen . The JSC will be responsible for the supply of any Products necessary for the FibroGen Clinical Studies, any Evaluation Activities under the Study Plan and the Fortis Additional Product Requirements, at its cost. All Products supplied by FibroGen pursuant to Fortis Additional Product Requirements (i) shall be manufactured in accordance with GMP and applicable specifications for such Products, shall not be adulterated or misbranded, and shall be free and clear of any liens or encumbrances, and (ii) shall otherwise comply with any quality agreement review events that the Parties may enter into with respect give rise to the Productsright to conduct a For Cause Audit if so requested by either Party. (d) Fortis will use [*] to cause COI to assign the COI STA Agreement to Fortis [*].

Manufacturing. (a) Fortis Centocor will manufacture the Product and use its existing inventory of Products as of ------------- diligent efforts to satisfy Schering-Plough's requirements for the Effective Date (“Existing Inventory”) to supply all Products necessary to conduct the Fortis Clinical Studies and Product. All Product manufactured for any other purposes set forth Schering-Plough for use and/or sale in the Study Plan that is to be supplied from the Existing Inventory. Fortis will not use the Existing Inventory for any other purpose unless approved by the JSC. To the extent that the Existing Inventory is insufficient for the requirements of the Fortis Clinical Studies or any other Study Plan activities meant to be supplied from the Existing Inventory, then FibroGen will be responsible for supplying any additional Products required to meet such outstanding requirement (“Fortis Additional Product Requirement”) at its cost. (b) Within [*], the Parties will meet in good faith to discuss the establishment of a Third Party supply of Products to FibroGen meeting any quantity and quality requirements of the applicable Study Plan activities, meeting the necessary timeframe required by the Study Plan, and on commercially reasonable terms (whether using Fortis’s existing supplier of Products or another Third Party supplier) (“Third Party Source”). The Parties will use Commercially Reasonable Efforts to cooperate and establish a Third Party Source to FibroGen within the timelines and in the quantities set forth in the Study Plan, which efforts by Fortis will include, solely if requested by FibroGen: (i) Fortis entering into an amendment to one or more supply agreements [*] to permit FibroGen to order, and to oversee and authorize all aspects of CMC (including Manufacturing) with respect to, such Products or related components, packaging or labeling, as applicable, under such supply agreements, in order to meet FibroGen’s obligations under this Agreement [*], provided that [*] to meet FibroGen’s obligations under this Agreement, at FibroGen’s [*]. (c) FibroGen will be responsible for the supply of any Products necessary for the FibroGen Clinical Studies, any Evaluation Activities under the Study Plan and the Fortis Additional Product Requirements, at its cost. All Products supplied by FibroGen pursuant to Fortis Additional Product Requirements (i) Territory shall be manufactured in accordance an approved facility. Centocor shall provide to Schering-Plough, concurrently with GMP each shipment of Product supplied to Schering-Plough under this Agreement (whether in the form of finished Product or in bulk) a Certificate of Analysis setting forth the CONFIDENTIAL TREATMENT REQUESTED. THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT THE PLACES INDICATED BY ASTERISKS (*); AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. analytical results and applicable specifications for the batch. In order to ensure the required supply of Product for sale pursuant to this Agreement, Centocor may contract with a third party acceptable to Schering-Plough to manufacture the Product. In the event that Schering-Plough elects to exercise its option under Section 5.1 to purchase the Product in bulk, Centocor shall cooperate with and provide reasonable assistance to Schering-Plough, at Schering-Plough's expense, to make available to Schering-Plough any Product specific know-how necessary to enable Schering-Plough to perform the final processing and packaging of the Product in its facilities and to obtain any necessary regulatory or manufacturing approvals for such Products, shall not be adulterated or misbranded, and shall be free and clear of any liens or encumbrances, and (ii) shall otherwise comply with any quality agreement that the Parties may enter into with respect to the Productsfacilities. (d) Fortis will use [*] to cause COI to assign the COI STA Agreement to Fortis [*].