Common use of Manufacturing Clause in Contracts

Manufacturing. (a) Subject to Section 4.3.4(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe declines to manufacture or, if Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period then Chiron shall have the right, at its option, to manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field; provided, however, that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. If Gen-Probe declines to manufacture as described above, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b4.2.4(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Exclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Exclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Exclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Exclusive Future Clinical Diagnostic Assay in accordance with Article 6. (b) With respect to each Nonexclusive Exclusive Future Clinical Diagnostic Assay which Gen-Probe declines to manufacture or, if Gen-Probe elects to manufacture, with respect to each Nonexclusive Exclusive Future Clinical Diagnostic Assay which Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Exclusive Future Clinical Diagnostic Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period period, then Chiron shall have the right, at its option, to manufacture (or to have manufactured) its requirements of such Nonexclusive Exclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field; provided, however, that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Exclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. If Gen-Probe declines to manufacture as described above, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Exclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, Gen-Gen- Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Exclusive Future Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Exclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Exclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b4.2.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Exclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b4.1.3(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured manufactured) and supply Chiron with Chiron's its order requirements for each Nonexclusive Future the Initial Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments Assays in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe declines to manufacture or, if Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future an Initial Clinical Diagnostic Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period then Chiron shall have the right, at its option, to manufacture (or to have manufactured) its requirements of such Nonexclusive Future Initial Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field; provided, however, that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Initial Clinical Diagnostic Assay in accordance with Article 6 below. If Gen-Probe declines to manufacture as described above, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) In such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described aboveevent, Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Initial Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Initial Clinical Diagnostic Assay which Gen-Probe manufacturesAssay. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b4.1.3(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Initial Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b3.1.3(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory [***] for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Blood Screening Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe declines (i) fails at any time during the Blood Screening Term to manufacture or, if [***] or the Supervisory Board agrees within fifteen days of such event that Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe shall retain the manufacturing responsibility hereunder); or (ii) fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements [***] for a Nonexclusive Future Clinical Diagnostic an Initial Blood Screening Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three [***] (3) months in any nineunless the Supervisory Board agrees within fifteen days of such event that Gen-month period Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the rightright to, at its optionand if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Assay Initial Blood Screening Assay, to be conducted by the Clinical Diagnostic Blood Screening Instruments in the Territory for use in the Clinical Diagnostic Blood Screening Field; provided, however, such right of Chiron shall be on an assay-by-assay basis for a failure to supply and provided further that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreementagreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Initial Blood Screening Assay in accordance with Article 6 below. If In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for the facility used by Gen-Probe declines to manufacture as described abovethe Initial Blood Screening Assays, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, and Gen-Probe promptly shall provide such *** 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 Nonexclusive Future Clinical Diagnostic Initial Blood Screening Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b3.1.3(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory [CONFIDENTIAL TREATMENT REQUESTED] for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Blood Screening Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe declines (i) fails at any time during the Blood Screening Term to manufacture or, if [CONFIDENTIAL TREATMENT REQUESTED] or the Supervisory Board agrees within fifteen days of such event that Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe shall retain the manufacturing responsibility hereunder); or (ii) fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements [CONFIDENTIAL TREATMENT REQUESTED] for a Nonexclusive Future Clinical Diagnostic an Initial Blood Screening Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three [CONFIDENTIAL TREATMENT REQUESTED] (3) months in any nineunless the Supervisory Board agrees within fifteen days of such event that Gen-month period Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the rightright to, at its optionand if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Assay Initial Blood Screening Assay, to be conducted by the Clinical Diagnostic Blood Screening Instruments in the Territory for use in the Clinical Diagnostic Blood Screening Field; providedPROVIDED, howeverHOWEVER, such right of Chiron shall be on an assay-by-assay basis for a failure to supply and provided further that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreementagreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Initial Blood Screening Assay in accordance with Article 6 below. If In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for the facility used by Gen-Probe declines to manufacture as described abovethe Initial Blood Screening Assays, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, and Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Initial Blood Screening Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. 4.2.4.1 Selecta shall be responsible for, and shall use Commercially Reasonable Efforts to conduct, the manufacture and supply of ImmTOR and all other Selecta Core Technology, necessary or useful (a) Subject for the conduct of Clinical Studies of the Collaboration Products, in accordance with the applicable Therapeutic Development Plan, and (b) for use with or for inclusion in Collaboration Products. AskBio shall be responsible for, and shall use Commercially Reasonable Efforts to conduct, the manufacture and supply of AAV capsids, AAV vectors, AAV particles, AAV production cells, and all other AskBio Core Technology necessary or useful (y) for the conduct of Clinical Studies, in accordance with the Therapeutic Development Plans, and (z) for use with or for inclusion in Collaboration Products. Each Party shall conduct its manufacturing and supply activities pursuant to this Section 4.2.4 in accordance with Applicable Law (including cGMPs for all clinical supply) and this Agreement. The costs of such manufacture and supply set forth in the Therapeutic Development Plan shall be shared equally, as Shared Costs. AskBio shall be responsible, itself or through Viralgen, for the manufacturing of all Collaboration Products excluding the manufacture of ImmTOR for use with or for inclusion in such Collaboration Products, and shall be paid for such manufacture of Collaboration Products based on mutually agreed upon rates, which rates shall include all of AskBio’s costs incurred with such manufacture of Collaboration Products without any markup. 4.2.4.2 Except as otherwise agreed by the Parties in writing, AskBio shall not exercise AskBio Collaboration Product License to make and have made ImmTOR for use with or for inclusion in Collaboration Products unless and until: (a) Selecta fails, or AskBio reasonably believes that Selecta will fail, to supply AskBio or its Affiliates’ requirements of ImmTOR in connection with the Collaboration, including as ordered pursuant to the supply agreement described in Section 4.2.4.4, (b) the Parties fail to enter into a supply agreement pursuant to Section 4.3.4(b) below4.2.4.4 prior to the initiation of the first Pivotal Clinical Study of such Collaboration Product if AskBio is the Lead Commercialization Party. If Selecta exercises the Opt-Out Option with respect to any Collaboration Indication or AskBio enters into a Partnership Agreement for a Collaboration Product, Gen-Probe Selecta shall have the right supply ImmTOR to manufacture AskBio or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory its designee for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, such Collaboration Indication or Collaboration Products at a cost equal price not to exceed Manufacturing Costs plus [***] and if Selecta does not supply ImmTOR for such purposes at such pricing AskBio may exercise its right to make and have made ImmTOR for use with or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, for inclusion in Collaboration Products pursuant to the preceding sentenceAskBio Collaboration Product License for use in such Collaboration Indication. 4.2.4.3 Except as otherwise agreed by the Parties in writing, Gen-Probe Selecta shall be obligated not exercise the Selecta Collaboration Product License to make and have made AAV vectors, transgenes or promoters for use with or for inclusion in Collaboration Products unless and until: (a) AskBio fails, or Selecta reasonably believes that AskBio will fail, to supply Chiron with AskBio or its Affiliates’ requirements of AAV vectors, transgenes or promoters, in connection with the Collaboration, including as ordered pursuant to the supply agreement described in Section 4.2.4.4, (c) the Parties fail to enter into a supply agreement pursuant to Section 4.2.4.4 prior to the initiation of the first Pivotal Clinical Study of such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which GenCollaboration Product if Selecta is the Lead Commercialization Party. If AskBio exercises the Opt-Probe declines to manufacture or, if Gen-Probe elects to manufacture, Out Option with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements any Collaboration Indication or Selecta enters into a Partnership Agreement for a Nonexclusive Future Clinical Diagnostic Assay as most recently forecasted Collaboration Product, AskBio shall supply AAV vectors, transgenes and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period then Chiron shall have the right, at promoters to Selecta or its option, to manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory designee for use in the Clinical Diagnostic Field; providedsuch Collaboration Indication or Collaboration Products, howeverand if AskBio does not supply AAV vectors, that transgenes or promoters for such purposes, , Selecta may exercise its right to make and have made AAV vectors, transgenes or promoters for use with or for inclusion in Collaboration Products pursuant to the extent GenSelecta Collaboration Product License for use in such Collaboration Indication. In the event that either AskBio exercises the Opt-Probe Out Option with respect to any Collaboration Indication or if Selecta is able allocated responsibility for the Manufacture of any Collaboration Product, then Selecta may engage with Viralgen directly to meet Chiron's requirements manufacture any relevant Collaboration Products and AskBio will use reasonable efforts to facilitate such discussions. 4.2.4.4 Prior to initiation of the first Pivotal Clinical Study of a Collaboration Product or in connection with a Potential Partnership upon request of the Commercialization Lead Party for Rare Reagents such Collaboration Product, or upon earlier request by either Party as reasonably necessary to support the Development or Commercialization of the Collaboration Products in accordance with this Agreement, Gen-Probe the Parties shall retain the exclusive right negotiate, promptly and in good faith, a supply agreement or manufacturing technology transfer arrangement, as is reasonably necessary or useful for such Commercialization Lead Party to manufacture (or to have manufactured) support such Pivotal Clinical Studies and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. If Gen-Probe declines to manufacture as described above, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements Commercialization of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic FieldCollaboration Products.

Manufacturing. (a) Subject to Section 4.3.4(b3.2.4(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory [***] for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Blood Screening Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe declines (i) fails at any time during the Blood Screening Term to manufacture or, if [***] or the Supervisory Board agrees within fifteen days of such event that Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe shall retain the manufacturing responsibility hereunder) or (ii) fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic [***] Blood Screening Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three [***] (3) months in any nineunless the Supervisory Board agrees within fifteen days of such event that Gen-month period Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the rightright to, at its optionand if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Blood Screening Assays,, all to the extent that any such Assay is to be conducted by the Clinical Diagnostic Blood Screening Instruments in the Territory for use in the Clinical Diagnostic Blood Screening Field; provided, however, such right of Chiron shall be on an assay-by-assay basis for a failure to supply and provided further that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Blood Screening Assay in accordance with Article 6 below. If In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe declines Probe's request, to take over control and responsibility for Gen-Probe's facility used to manufacture as described abovethe Future Blood Screening Assays, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, and Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Blood Screening Assay. (c) Chiron shall maintain at its expense If a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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 *** 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. party shall enter into an agreement with such party to the extent necessary to effectuate the provisions of Article 9 below. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b3.2.4(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured manufactured) and supply Chiron with Chiron's its requirements for each Nonexclusive of the Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments Blood Screening Assays in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Blood Screening Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe declines (i) fails at any time during the Blood Screening Term to maintain the applicable FDA (CBER) license for the facility used to manufacture or, if the Future Blood Screening Assays (unless Gen-Probe elects is approved by CBER to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which manufacture from an alternate location or the Supervisory Board agrees within fifteen days of such event that Gen-Probe shall retain the manufacturing responsibility hereunder) or (ii) fails to supply Chiron within forty-five (45) days of [***] after the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic Blood Screening Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three [***] (3) months in any nineunless the Supervisory Board agrees within fifteen days of such event that Gen-month period Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the rightright to, at its optionand if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Blood Screening Assays,, all to the extent that any such Assay is to be conducted by the Clinical Diagnostic Blood Screening Instruments in the Territory for use in the Clinical Diagnostic Blood Screening Field; provided, however, such right of Chiron shall be on an assay-by-assay basis for a failure to supply and provided further that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Blood Screening Assay in accordance with Article 6 below. If In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe declines Probe's request, to take over control and responsibility for Gen-Probe's facility used to manufacture as described abovethe Future Blood Screening Assays, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, and Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Blood Screening Assay. (c) Chiron shall maintain at its expense If a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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 *** 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. party shall enter into an agreement with such party to the extent necessary to effectuate the provisions of Article 9 below. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b3.1.3(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured manufactured) and supply Chiron with Chiron's its requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by of the Clinical Diagnostic Instruments Initial Blood Screening Assays in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Blood Screening Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe declines (i) fails at any time during the Blood Screening Term to maintain the applicable FDA (CBER) license for the facility used to manufacture or, if an Initial Blood Screening Assay (unless Gen-Probe elects is approved by CBER to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which manufacture from an alternate location or the Supervisory Board agrees within fifteen days of such event that Gen-Probe shall retain the manufacturing responsibility hereunder); or (ii) fails to supply Chiron within forty-five (45) days of [***] after the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic an Initial Blood Screening Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three [***] (3) months in any nineunless the Supervisory Board agrees within fifteen days of such event that Gen-month period Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the rightright to, at its optionand if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Assay Initial Blood Screening Assay, to be conducted by the Clinical Diagnostic Blood Screening Instruments in the Territory for use in the Clinical Diagnostic Blood Screening Field; provided, however, such right of Chiron shall be on an assay-by-assay basis for a failure to supply and provided further that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreementagreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Initial Blood Screening Assay in accordance with Article 6 below. If In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for the facility used by Gen-Probe declines to manufacture as described abovethe Initial Blood Screening Assays, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, and Gen-Probe promptly shall provide such *** 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 Nonexclusive Future Clinical Diagnostic Initial Blood Screening Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. (a) Subject to Section 4.3.4(b3.2.4(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory [CONFIDENTIAL TREATMENT REQUESTED] for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay Blood Screening Field in accordance with Article 66 below. (b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which If Gen-Probe declines (i) fails at any time during the Blood Screening Term to manufacture or, if [CONFIDENTIAL TREATMENT REQUESTED] or the Supervisory Board agrees within fifteen days of such event that Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe shall retain the manufacturing responsibility hereunder) or (ii) fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic [CONFIDENTIAL TREATMENT REQUESTED] Blood Screening Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three [CONFIDENTIAL TREATMENT REQUESTED] (3) months in any nineunless the Supervisory Board agrees within fifteen days of such event that Gen-month period Probe shall retain the manufacturing responsibility hereunder), then Chiron shall have the rightright to, at its optionand if Chiron elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Blood Screening Assays, all to the extent that any such Assay is to be conducted by the Clinical Diagnostic Blood Screening Instruments in the Territory for use in the Clinical Diagnostic Blood Screening Field; providedPROVIDED, howeverHOWEVER, such right of Chiron shall be on an assay-by-assay basis for a failure to supply and provided further that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Blood Screening Assay in accordance with Article 6 below. If In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe declines Probe's request, to take over control and responsibility for Gen-Probe's facility used to manufacture as described abovethe Future Blood Screening Assays, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, and Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Blood Screening Assay. (c) Chiron shall maintain at its expense If a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy of the amount of the safety stock held by each party and make adjustments thereto as appropriate. (d) Upon (i) any notice of anticipated supply problem issued by Gen-Probe pursuant to Section 6.3.4 or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilities, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectively. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party pursuant to Section 4.3.1 above in the Territory for use in the Clinical Diagnostic Field.

Manufacturing. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (a) Subject to Section 4.3.4(b) below6.4(d), Gen-Probe if Clinical Trial Materials manufactured by or on behalf of Alexza for a Program do not conform with the applicable specifications, then Alexza shall have the right use commercially reasonable efforts to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future replace such Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, Trial Materials at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6Alexza’s sole expense. (b) With respect Subject to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe declines to manufacture orSection 6.4(d), if Gen-Probe elects to manufactureAlexza foresees or experiences difficulty in supplying Clinical Trial Materials for the Programs, it shall notify Symphony Allegro and confer with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe fails to supply Chiron within forty-five (45) days the Development Committee regarding the source of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic Assay as most recently forecasted problem and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period then Chiron shall have the right, at its option, Alexza’s plans to manufacture (or to have manufactured) its requirements of address such Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field; provided, however, that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. If Gen-Probe declines to manufacture as described above, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above, Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe's sole cost, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assayproblem. (c) Chiron shall maintain Subject to Section 6.4(d), if on two (2) separate occasions during the Term Alexza materially breaches its Clinical Trial Materials supply obligation hereunder by failing to supply at its expense a sixty (60) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe manufactures. The Supervisory Board shall periodically review the adequacy least [ * ] of the amount ordered or failing to replace non-conforming Clinical Trial Material on time and fails to cure such breach within [ * ] of Symphony Allegro’s written notice thereof, then upon Symphony Allegro’s written notice that Alexza has materially breached for a third (3rd) time, its Clinical Trial Materials supply obligation hereunder by failing to supply at least [ * ] of the safety stock held amount ordered or failing to replace non-conforming Clinical Trial Material on time, the Parties shall negotiate in good faith to agree upon a mechanism for Symphony Allegro to obtain an alternate source of Clinical Trial Material supply (including seeking to validate an alternate manufacturing source and granting such licenses as may be required). In the event that, despite such good faith negotiations, Symphony Allegro and Alexza fail to reach an agreement regarding an alternate source within [ * ] after Symphony Allegro’s notice regarding such third (3rd) breach, then upon Symphony Allegro’s request, the Parties shall amend the Novated and Restated Technology License Agreement to expand the license granted to Symphony Allegro pursuant to Section 2.2 thereof to include the non-exclusive right to manufacture, or have manufactured, the Product(s) affected by each party and make adjustments thereto as appropriatesuch breach. (d) Upon If a force majeure event causes Alexza to materially default on or breach its obligations hereunder to manufacture Clinical Trial Materials for the Program, Alexza shall promptly notify Symphony Allegro of such force majeure event and shall keep Symphony Allegro apprised of the status of its efforts to eliminate the effects of such force majeure event or otherwise regain its ability to fulfill its Clinical Trial Material manufacturing obligation. If such a force majeure event persists for six (i6) any notice of anticipated supply problem issued by Gen-Probe months or more, then upon Symphony Allegro’s request, the Parties shall amend the Novated and Restated Technology License Agreement to expand the license granted to Symphony Allegro pursuant to Section 6.3.4 2.2 thereof to include the non-exclusive right to manufacture, or (ii) any failure of Gen-Probe to supply Chiron as set forth in Section 4.3.4(b) and prior to Chiron's assumption of manufacturing responsibilitieshave manufactured, the Supervisory Board shall meet and discuss in good faith alternative manufacturing strategies and shall select the strategy which meets the supply and quality requirements of the parties at the least cost to the parties collectivelyProduct(s) affected by such force majeure. (e) If either party exercises any right granted hereunder to have any Nonexclusive Future Clinical Diagnostic Assay manufactured, then (i) such party shall first require In the event that the subcontracted party shall enter into a confidentiality agreement with such party incorporating Parties amend 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 Novated 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. (f) Subject to Section 4.3.7 below, Gen-Probe shall have the right to manufacture (or to have manufactured) its requirements of such each Nonexclusive Future Clinical Diagnostic Assay for which it is the Developing Party Restated Technology License Agreement pursuant to Section 4.3.1 above 6.4(c) or 6.4(d), Alexza shall, at the reasonable request of the Development Committee and at the expense of Symphony Allegro, transfer and deliver to Symphony Allegro (or RRD on behalf of Symphony Allegro) copies of any and all consents, materials, documents, files and other information (excluding Drug Master Files, but subject to Symphony Allegro’s rights under Section 2.7(a)(i) of the Novated and Restated Technology License Agreement) that are necessary for another entity to manufacture such Product(s); provided, that Alexza shall be permitted to retain the originals of such [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Territory for use in Securities and Exchange Commission pursuant to Rule 24b-2 of the Clinical Diagnostic FieldSecurities Exchange Act of 1934, as amended.