Common use of Manufacturing Clause in Contracts

Manufacturing. (a) Subject to Section 4.1.3(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) and supply Chiron with its order requirements for the Initial Clinical Diagnostic Assays in the Territory for use in the Clinical Diagnostic Field in accordance with Article 6 below. (b) If Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for 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 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 Initial Clinical Diagnostic Assay in accordance with Article 6 below. In such event, 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 Initial Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Clinical Diagnostic Assay. 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 4.1.3(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 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.

Manufacturing. (a) Subject to Section 4.1.3(b4.3.4(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) manufactured and supply Chiron with its order Chiron's requirements for the Initial each Nonexclusive Future Clinical Diagnostic Assays Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field 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 below6. (b) If 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 an Initial 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 Initial 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 Initial Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. In 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 eventNonexclusive 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 Initial Nonexclusive Future Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Initial Nonexclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Nonexclusive Future Clinical Diagnostic AssayAssay 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 4.1.3(b4.3.4(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 Initial 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 4.1.3(b4.2.4(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) manufactured and supply Chiron with its order Chiron's requirements for the Initial each Exclusive Future Clinical Diagnostic Assays Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of 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 Exclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Exclusive Future Clinical Diagnostic Assay in accordance with Article 6 below6. (b) If With respect to each Exclusive Future Clinical Diagnostic Assay which Gen-Probe declines to manufacture or, if Gen-Probe elects to manufacture, with respect to each 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 an Initial a 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 Initial 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 Initial Exclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. In such eventIf 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 Exclusive 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 Initial Exclusive Future Clinical Diagnostic Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Initial Exclusive Future Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Exclusive Future Clinical Diagnostic AssayAssay 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 4.1.3(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 Initial 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.

Manufacturing. (a) Subject to Section 4.1.3(b3.2.4(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) and supply Chiron with its order requirements for the Initial Clinical Diagnostic Assays in the Territory [***] for use in the Clinical Diagnostic Blood Screening Field in accordance with Article 6 below. (b) If Gen-Probe (i) fails at any time during the Blood Screening Term to [***] 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 the requested delivery date with Chiron's monthly requirements for an Initial 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 Initial Clinical Diagnostic Future 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 Initial Clinical Diagnostic Future Blood Screening Assay in accordance with Article 6 below. In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for Gen-Probe's facility used to manufacture the Future Blood Screening Assays, 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 Initial Clinical Diagnostic Future Blood Screening Assay. (c) Chiron shall maintain at its expense If a sixty (60) day finished goods safety stock for each Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Clinical Diagnostic Assay. 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 4.1.3(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 Initial Clinical Diagnostic Future 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.

Manufacturing. (a) Subject to Section 4.1.3(b3.2.4(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) and supply Chiron with its order requirements for the Initial Clinical Diagnostic Assays in the Territory [CONFIDENTIAL TREATMENT REQUESTED] for use in the Clinical Diagnostic Blood Screening Field in accordance with Article 6 below. (b) If Gen-Probe (i) fails at any time during the Blood Screening Term to [CONFIDENTIAL TREATMENT REQUESTED] 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 the requested delivery date with Chiron's monthly requirements for an Initial 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 Initial Clinical Diagnostic Future 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 Initial Clinical Diagnostic Future Blood Screening Assay in accordance with Article 6 below. In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for Gen-Probe's facility used to manufacture the Future Blood Screening Assays, 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 Initial Clinical Diagnostic Future Blood Screening Assay. (c) Chiron shall maintain at its expense If a sixty (60) day finished goods safety stock for each Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Clinical Diagnostic Assay. 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 4.1.3(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 Initial Clinical Diagnostic Future Blood Screening Assay manufactured, then (i) such party shall first require that the subcontracted party shall enter into a confidentiality agreement with such party incorporating the terms of Article 8 below; (ii) such party shall supervise such subcontract work; (iii) the subcontracted party shall comply in all material respects with all requirements of applicable laws and regulations, together with all applicable good laboratory, clinical and manufacturing practices; and (iv) the subcontracted party shall enter into an agreement with such party to the extent necessary to effectuate the provisions of Article 9 below.

Manufacturing. (a) Subject to Section 4.1.3(b3.1.3(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) and supply Chiron with its order requirements for the Initial Clinical Diagnostic Assays in the Territory [CONFIDENTIAL TREATMENT REQUESTED] for use in the Clinical Diagnostic Blood Screening Field in accordance with Article 6 below. (b) If Gen-Probe (i) fails at any time during the Blood Screening Term to [CONFIDENTIAL TREATMENT REQUESTED] 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 the requested delivery date with Chiron's monthly requirements [CONFIDENTIAL TREATMENT REQUESTED] for an Initial Clinical Diagnostic 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 Initial Clinical Diagnostic Assay 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 Initial Clinical Diagnostic Blood Screening Assay in accordance with Article 6 below. In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for the facility used by Gen-Probe to manufacture the Initial Blood Screening Assays, 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 Initial Clinical Diagnostic Blood Screening Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Clinical Diagnostic Assay. 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 4.1.3(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 Initial 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.

Manufacturing. (a) Subject to Section 4.1.3(b3.1.3(b) below, Gen-Probe shall have the exclusive right and the obligation to manufacture (or to have manufactured) and supply Chiron with its order requirements for the Initial Clinical Diagnostic Assays in the Territory [***] for use in the Clinical Diagnostic Blood Screening Field in accordance with Article 6 below. (b) If Gen-Probe (i) fails at any time during the Blood Screening Term to [***] 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 the requested delivery date with Chiron's monthly requirements [***] for an Initial 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 Initial Clinical Diagnostic Assay 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 Initial Clinical Diagnostic Blood Screening Assay in accordance with Article 6 below. In such event, Chiron shall consider in good faith, as its preferred alternative upon Gen-Probe's request, to take over control and responsibility for the facility used by Gen-Probe to manufacture the Initial Blood Screening Assays, 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 Initial Clinical Diagnostic Blood Screening Assay. (c) Chiron shall maintain at its expense a sixty (60) day finished goods safety stock for each Initial Clinical Diagnostic Assay and Gen-Probe shall maintain a thirty (30) day finished goods safety stock for each Initial Clinical Diagnostic Assay. 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 4.1.3(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 Initial 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.