Common use of Alternative Supply Arrangements Clause in Contracts

Alternative Supply Arrangements. Unless otherwise determined by the JSC, in the event that: (a) the Lead Manufacturing Party proposes to enter into one or more new manufacturing agreements, (b) the Lead Manufacturing Party proposes to materially amend, to renegotiate or to renew its then existing Third Party manufacturing agreements, or (c) the Lead Manufacturing Party notifies the JSC that capacity or quality under the existing Third Party manufacturing agreements will not be sufficient to meet the needs of the Parties under the Development Plan, the JSC shall determinate the appropriate course of action, including a [ * ] = 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. determination of whether a second source of supply is appropriate. In any event, the Lead Manufacturing Party shall notify the other Party and the JSC prior to entry into any such new, amended or renewed Third Party manufacturing agreement, and the JSC shall review and approve the proposed terms of such new, amended or renewed agreement; provided that such agreement may include, as agreed upon by the JSC (i) attempting to order in full lot or production run batches and otherwise reducing the Manufacturing Cost of Collaboration Product, (ii) providing for sufficient capacity and timely supply to satisfy the requirements of the then-current Development Plan, (iii) having Facet and Trubion as parties (and in any event third party beneficiaries) with respect to the rights and obligations related to Collaboration Products pursuant to such Third Party agreement, (iv) ensuring that in the event of the exercise or deemed exercise of an Opt-Out Option by a Party, the remaining Party shall be the sole obligor pursuant to such Third Party Agreement, (v) providing that the Parties shall have joint rights and obligations under the agreement with respect to Collaboration Product, but that one Party shall be designated as the “principal party” under such agreement, (v) providing both Parties with the right to audit and inspect such Third Party’s facilities on at least [ * ], which efforts shall be coordinated between the Parties in the event both Parties desire to conduct such audit and inspection, and (vi) providing for complete sharing of any and all information under and the terms and conditions of such agreement between the Parties. The Lead Manufacturing Party shall be responsible for negotiating the terms of such agreement, with the other Party having consultation and review rights on the terms of such Third Party agreement.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Facet Biotech Corp), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

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Alternative Supply Arrangements. Unless otherwise determined by the JSC, in the event that: (a) the Lead Manufacturing Party proposes to enter into one or more new manufacturing agreements, (b) the Lead Manufacturing Party proposes to materially amend, to renegotiate or to renew its then existing Third Party manufacturing agreements, or (c) the Lead Manufacturing Party notifies the JSC that capacity or quality under the existing Third Party manufacturing agreements will not be sufficient to meet the needs of the Parties under the Development Plan, the JSC shall determinate the appropriate course of action, including a [ * ] = 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. determination of whether a second source of supply is appropriate. In any event, the Lead Manufacturing Party shall notify the other Party and the JSC prior to entry into any such new, amended or renewed Third Party manufacturing agreement, and the JSC shall review and approve the proposed terms of such new, amended or renewed agreement; provided that such agreement may include, as agreed upon by the JSC (i) attempting to order in full lot or production run batches and otherwise reducing the Manufacturing Cost of Collaboration Product, (ii) providing for sufficient capacity and timely supply to satisfy the requirements of the then-current Development Plan, (iii) having Facet and Trubion as parties (and in any event third party beneficiaries) with respect to the rights and obligations related to Collaboration Products pursuant to such Third Party agreement, (iv) ensuring that in the event of the exercise or deemed exercise of an Opt-Out Option by a Party, the remaining Party shall be the sole obligor pursuant to such Third Party Agreement, (v) providing that the Parties shall have joint rights and obligations under the agreement with respect to Collaboration Product, but that one Party shall be designated as the “principal party” under such agreement, (v) providing both Parties with the right to audit and inspect such Third Party’s facilities on at least [ * ], which efforts shall be coordinated between the Parties in the event both Parties desire to conduct such audit and inspection, and (vi) providing for complete sharing of any and all information under and the terms and conditions of such agreement between the Parties. The Lead Manufacturing Party shall be responsible for negotiating the terms of such agreement, with the other Party having consultation and review rights on the terms of such Third Party agreement.

Appears in 1 contract

Samples: Collaboration and License Agreement (Facet Biotech Corp)

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Alternative Supply Arrangements. Unless otherwise determined by the JSC, in the event that: (a) the Lead Manufacturing Party proposes to enter into one or more new manufacturing agreements, (b) the Lead Manufacturing Party proposes to materially amend, to renegotiate or to renew its then existing Third Party manufacturing agreements, or (c) the Lead Manufacturing Party notifies the JSC that capacity or quality under the existing Third Party manufacturing agreements will not be sufficient to meet the needs of the Parties under the Development Plan, the JSC shall determinate the appropriate course of action, including a [ * ] = 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. determination of whether a second source of supply is appropriate. In any event, the Lead Manufacturing Party shall notify the other Party and the JSC prior to entry into any such new, amended or renewed Third Party manufacturing agreement, and the JSC shall review and approve the proposed terms of such new, amended or renewed agreement; provided that such agreement may include, as agreed upon by the JSC (i) attempting to order in full lot or production run batches and otherwise reducing the Manufacturing Cost of Collaboration Product, (ii) providing for sufficient capacity and timely supply to satisfy the requirements of the then-current Development Plan, (iii) having Facet and Trubion as parties (and in any event third party beneficiaries) with respect to the rights and obligations related to Collaboration Products pursuant to such Third Party agreement, (iv) ensuring that in the event of the exercise or deemed exercise of an Opt-Out Option by a Party, the remaining Party shall be the sole obligor pursuant to such Third Party Agreement, (v) providing that the Parties shall have joint rights and obligations under the agreement with respect to Collaboration Product, but that one Party shall be designated as the “principal party” under such agreement, (v) providing both Parties with the right to audit and inspect such Third Party’s facilities on at least [ * [*], which efforts shall be coordinated between the Parties in the event both Parties desire to conduct such audit and inspection, and (vi) providing for complete sharing of any and all information under and the terms and conditions of such agreement between the Parties. The Lead Manufacturing Party shall be responsible for negotiating the terms of such agreement, with the other Party having consultation and review rights on the terms of such Third Party agreement.

Appears in 1 contract

Samples: Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

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