Common use of Contract Manufacture Process Clause in Contracts

Contract Manufacture Process. FibroGen is currently utilizing a contract manufacturer to fulfill its manufacturing timelines to complete drug product development in time for the expected commercial launch of the Product in the U.S. and under the Astellas Agreements. Notwithstanding the provisions of Section 6.3, upon AstraZeneca’s written request to FibroGen, not to be submitted earlier than six (6) months after the Effective Date, the Parties will discuss in good faith whether to select a separate contract manufacturer mutually acceptable to the Parties to be used for formulation and bulk drug product manufacture (using drug substance supplied by FibroGen) for commercial supply under this Agreement. The Parties shall discuss in good faith the transfer, including timely technology transfer, as soon as practicable following such mutual agreement. Such selection will be conducted in accordance with the following process: As soon as reasonably practicable following AstraZeneca’s request, the Parties will afford an opportunity for at least two (2) different Third Party contract manufacturers that are mutually acceptable to the Parties, consent not to be unreasonably withheld, to submit bids to conduct such manufacture. Such bids shall be based on a request for quotation, the contents of which shall be agreed by the Parties in good faith (and shall contain such specifications and forecasts as are reasonably necessary for a contract manufacturer to submit a bid with respect to such manufacture). AstraZeneca and its Affiliates shall provide a proposal on the same basis as the Third Party contract manufacturers. The Parties shall review and assess in good faith the bids submitted by the Third Party manufacturers and by AstraZeneca or its Affiliate and shall recommend to the JDC the bid that, on the whole, offers the most favorable terms for such manufacture based on a reasonable assessment of the relevant factors, including price, capital requirements, quality, capacity, capability to maintain continuity of supplies, considerations related to the supply of Product to Astellas and global supply of Product and overall timeline. FibroGen will enter into a supply and quality contract with the Third Party contract manufacturer, on terms consistent with the selected bid and otherwise reasonably acceptable to the Parties, or the responsibility to manufacture shall be transferred to AstraZeneca, as determined by the JDC. In the event FibroGen shall contract with AstraZeneca or its Affiliate in accordance with this Section 6.4, FibroGen shall – as soon as reasonably practicable after the completion of the selection process – provide the necessary technology transfer as well as all necessary assistance to obtain required regulatory approvals, all

Contract Manufacture Process. FibroGen is currently utilizing a contract manufacturer to fulfill its manufacturing timelines to complete drug product development in time for the expected commercial launch of the Product in the U.S. and under the Astellas Agreements. Notwithstanding the provisions of Section 6.3, upon AstraZeneca’s written request to FibroGen, not to be submitted earlier than six (6) months after the Effective Date, the Parties will discuss in good faith whether to select a separate contract manufacturer mutually acceptable to the Parties to be used for formulation and bulk drug product manufacture (using drug substance supplied by FibroGen) for commercial supply under this Agreement. The Parties shall discuss in good faith the transfer, including timely technology transfer, as soon as practicable following such mutual agreement. Such selection will be conducted in accordance with the following process: As soon as reasonably practicable following AstraZeneca’s request, the Parties will afford an opportunity for at least two (2) different Third Party contract manufacturers that are mutually acceptable to the Parties, consent not to be unreasonably withheld, to submit bids to conduct such manufacture. Such bids shall be based on a request for quotation, the contents of which shall be agreed by the Parties in good faith (and shall contain such specifications and forecasts as are reasonably necessary for a contract manufacturer to submit a bid with respect to such manufacture). AstraZeneca and its Affiliates shall provide a proposal on the same basis as the Third Party contract manufacturers. The Parties shall review and assess in good faith the bids submitted by the Third Party manufacturers and by AstraZeneca or its Affiliate and shall recommend to the JDC the bid that, on the whole, offers the most favorable terms for such manufacture based on a reasonable assessment of the relevant factors, including price, capital requirements, quality, capacity, capability to maintain continuity of supplies, considerations related to the supply of Product to Astellas and global supply of Product and overall timeline. FibroGen will enter into a supply and quality contract with the Third Party contract manufacturer, on terms consistent with the selected bid and otherwise reasonably acceptable to the Parties, or the responsibility to manufacture shall be transferred to AstraZeneca, as determined by the JDC. In the event FibroGen shall contract with AstraZeneca or its Affiliate in accordance with this Section 6.4, FibroGen shall – as soon as reasonably practicable after the completion of the selection process – provide the necessary technology transfer as well as all necessary assistance to obtain required regulatory approvals, allall to enable AstraZeneca or its Affiliate to conduct the formulation and bulk drug product manufacture (using drug substance supplied by FibroGen) for supply of Product under this Agreement, and to Astellas under the Astellas Agreements. If AstraZeneca is not selected as the contract manufacturer, then at any time after the [ * ], at AstraZeneca’s request, the Parties shall [ * ]. For clarity, to the extent that the alternative formulation and drug product manufacture is transferred to such Third Party, FibroGen shall have the right to use such source of supply to satisfy FibroGen’s obligations under the Astellas Agreements.

Contract Manufacture Process. FibroGen is currently utilizing a contract manufacturer to fulfill its manufacturing timelines to complete drug product development in time for the expected commercial launch of the Product in the U.S. and under the Astellas Agreements. Notwithstanding the provisions of Section 6.3, upon AstraZeneca’s written request to FibroGen, not to be submitted earlier than six (6) months after the Effective Date, the Parties will discuss in good faith whether to select a separate contract manufacturer mutually acceptable to the Parties to be used for formulation and bulk drug product manufacture (using drug substance supplied by FibroGen) for commercial supply under this Agreement. The Parties shall discuss in good faith the transfer, including timely technology transfer, as soon as practicable following such mutual agreement. Such selection will be conducted in accordance with the following process: As soon as reasonably practicable following AstraZeneca’s request, the Parties will afford an opportunity for at least two (2) different Third Party contract manufacturers that are mutually acceptable to the Parties, consent not to be unreasonably withheld, to submit bids to conduct such manufacture. Such bids shall be based on a request for quotation, the contents of which shall be agreed by the Parties in good faith (and shall contain such specifications and forecasts as are reasonably necessary for a contract manufacturer to submit a bid with respect to such manufacture). AstraZeneca and its Affiliates shall provide a proposal on the same basis as the Third Party contract manufacturers. The Parties shall review and assess in good faith the bids submitted by the Third Party manufacturers and by AstraZeneca or its Affiliate and shall recommend to the JDC the bid that, on the whole, offers the most favorable terms for such manufacture based on a reasonable assessment of the relevant factors, including price, capital requirements, quality, capacity, capability to maintain continuity of supplies, considerations related to the supply of Product to Astellas and global supply of Product and overall timeline. FibroGen will enter into a supply and quality contract with the Third Party contract manufacturer, on terms consistent with the selected bid and otherwise reasonably acceptable to the Parties, or the responsibility to manufacture shall be transferred to AstraZeneca, as determined by the JDC. In the event FibroGen shall contract with AstraZeneca or its Affiliate in accordance with this Section 6.4, FibroGen shall – as soon as reasonably practicable after the completion of the selection process – provide the necessary technology transfer as well as all necessary assistance to obtain required regulatory approvals, all,