Common use of Development Supply Clause in Contracts

Development Supply. AssemblyBio shall, either by itself or through a CMO, Manufacture and supply to BeiGene all Licensed Products required by BeiGene for Development use in the Territory under the Territory Development Plan and for BeiGene’s Development-related responsibilities under the Global Development Plan, subject to the terms and conditions of the Clinical Supply Agreement. The Parties shall use Commercially Reasonable Efforts to enter into an agreement governing the supply by AssemblyBio of such Licensed Products for such Development use by BeiGene (“Clinical Supply Agreement”) within [* * *] after the Effective Date, pursuant to which BeiGene shall purchase its clinical requirements for Licensed Product in the Territory from AssemblyBio. AssemblyBio shall supply the Licensed Products pursuant to this Section 7.2(a) in [* * *] at a transfer price [* * *]. AssemblyBio shall invoice BeiGene for Licensed Products [* * *] in accordance with this Section 7.2 and BeiGene shall, subject to the terms of the Clinical Supply Agreement, pay the undisputed invoiced amounts within [* * *] after the date of such invoice. Notwithstanding the foregoing, in the event AssemblyBio will incur, [* * *], any advance fee or charge, including a slot reservation fee, advance raw material charges, or other similar fees or charges for Manufacture of Licensed Product solely for BeiGene, AssemblyBio may invoice BeiGene for such fee or charge, as applicable, [* * *], and BeiGene shall, pay such invoiced amounts within [* * *] after the date of such invoice. Amounts paid by BeiGene for clinical supply of Licensed Products under this Agreement will be included among Development and Regulatory Costs and shared by the Parties in accordance with Section 5.4.

Development Supply. AssemblyBio shall(a) From the Effective Date through ***, either by itself or through a CMO, Manufacture and BioCryst will supply to BeiGene all Shionogi, at Shionogi‘s expense, and Shionogi agrees to purchase exclusively from BioCryst, (i) the Licensed Products required by BeiGene Product (including its placebos if needed) for Development use in clinical studies to be conducted in the Territory under by or on behalf of (subject to the terms of Section 3.4, above) Shionogi, and (ii) the Compound necessary for the Development of the Licensed Product. (b) On ***, BioCryst will supply Shionogi with Compound (at Shionogi’s expense) and Shionogi will have established the necessary resources to formulate Licensed Product from Compound for clinical use. The Parties agree to evaluate in good faith the above arrangement on an ongoing basis to ensure the timely progression and development of the Licensed Product in the Territory. (c) During the term of this Agreement, BioCryst shall supply to Shionogi, *** of Compound (in such individual amounts and at such times as reasonably agreed upon by the Parties) for Shionogi to use Diligent Efforts to develop an optimized intramuscular formulation of the Compound for use by Shionogi in the Territory Development Plan and for BeiGeneuse by BioCryst outside the Territory pursuant to Section 10.2. In addition, if the Parties agree in writing that Shionogi may explore the possibility to Develop New Formulations under mutually agreed conditions, BioCryst shall also supply to Shionogi, *** (but upon such additional terms and conditions as the Parties may agree), the Compound for Development of such New Formulation. Both Parties understand and agree that there are no assurances that Shionogi’s Development-related efforts will generate an optimized intramuscular formulation of the Compound or lead to the successful Development of New Formulations. (d) All Licensed Product and Compound delivered by BioCryst to Shionogi shall be manufactured in accordance and in compliance with the specifications to be determined by BioCryst; provided, however that BioCryst shall give due consideration to revised specifications (if any) requested by Shionogi. BioCryst shall carry out its responsibilities under hereunder in conformance with cGMPs and all other applicable Laws (all of the Global Development Planforegoing, in the United States). All supply of Licensed Product and Compound shall be subject to the terms and conditions of the Clinical Supply Agreement. The Parties shall use Commercially Reasonable Efforts to enter into an agreement governing the supply by AssemblyBio of such Licensed Products for such Development use by BeiGene (“Clinical Supply Agreement”) within [* * *] after the Effective Date, pursuant to which BeiGene shall purchase its clinical requirements for Licensed Product set forth in the Territory from AssemblyBio. AssemblyBio shall supply the Licensed Products pursuant to this Section 7.2(a) in [* * *] at a transfer price [* * *]. AssemblyBio 3.5 and shall invoice BeiGene for Licensed Products [* * *] in accordance with this Section 7.2 and BeiGene shall, be subject to the terms and on prices as attached in Schedule 3.5 hereto. (e) BioCryst shall transfer to Shionogi the formulation and manufacturing processes that (i) are maintained or subsequently developed or optimized by BioCryst and (ii) are designed to ensure the quality of the Clinical Supply Agreement, pay the undisputed invoiced amounts within [* * *] after the date Licensed Product. All transfer of such invoice. Notwithstanding the foregoingKnow-How shall take place in Birmingham, in the event AssemblyBio will incur, [* * *], any advance fee or charge, including a slot reservation fee, advance raw material charges, or other similar fees or charges for Manufacture of Licensed Product solely for BeiGene, AssemblyBio may invoice BeiGene for such fee or charge, as applicable, [* * *], and BeiGene shall, pay such invoiced amounts within [* * *] after the date of such invoice. Amounts paid by BeiGene for clinical supply of Licensed Products under this Agreement will be included among Development and Regulatory Costs and shared Alabama unless otherwise agreed upon by the Parties in accordance with Section 5.4Parties. If the transfer is to occur wholly or partially outside of Birmingham, Alabama, then Shionogi shall promptly ***.

Development Supply. AssemblyBio shallSubject to Sections 7.2 and 7.3(b), Zymeworks shall have the right, either by itself or through a CMOThird Party contract manufacturer, Manufacture to manufacture and supply to BeiGene all Licensed Products required by BeiGene for Development use in the Territory under the Territory Development Plan and for BeiGene’s Development-related responsibilities under the Global Development Plan, subject including the conduct of any ZW49 Multi-Regional Clinical Study. Subject to Section 7.2, the terms and conditions of the Clinical Supply Agreement. The Parties shall use Commercially Reasonable Efforts to enter into an agreement governing the supply by AssemblyBio Zymeworks of such Licensed Products for such Development use by BeiGene (“Clinical Supply Agreement”) within [* * …***…] after following BeiGene’s receipt of the Effective DateTrial Completion Notice, pursuant to which BeiGene shall purchase its clinical requirements for Licensed Product in the Territory from AssemblyBio. AssemblyBio which:63 (i) Zymeworks shall supply the Licensed Products pursuant to this Section 7.2(a7.3(a) in [* * *] at a transfer price [* * …***…]. AssemblyBio Zymeworks shall invoice BeiGene for the Licensed Products [* * *] Product upon delivery in accordance with this Section 7.2 7.3 and BeiGene shall, subject to the terms of the Clinical Supply Agreement, pay the undisputed invoiced amounts within [* * …***…] after the date of such invoice. Notwithstanding the foregoing, in the event AssemblyBio Zymeworks will incur, [* * …***…], any advance fee or charge, including a slot reservation fee, advance raw material charges, or other similar fees or charges for Manufacture of Licensed Product solely for BeiGene, AssemblyBio Zymeworks may invoice BeiGene for such fee or charge, as applicable, [* * …***…], and BeiGene shall, pay such invoiced amounts within [* * …***…] after the date of such invoice. Amounts paid by BeiGene for clinical supply invoice.64 (ii) Delivery of Licensed Products under this Agreement supplied by Zymeworks for Development will be included among Development made Ex Works (Incoterms 2010) Zymeworks’ or its contract manufacturer’s facility. BeiGene shall be responsible for obtaining all licenses or other authorizations for the exportation and Regulatory Costs importation of such Licensed Product, and shared by BeiGene shall contract for shipment and insurance of such Licensed Product from Zymeworks’ or its contract manufacturer’s facility, […***…]. BeiGene shall also be responsible for the Parties in accordance with Section 5.4.clinical packaging, 62 Competitive Information – Commercially Sensitive Terms. 63 Competitive Information – Commercially Sensitive Terms. 64 Competitive Information – Commercially Sensitive Terms and Financial Provisions. labeling, QC/QA/QP release, storage, customs clearance and distribution of such Licensed Product, […***…].65

Development Supply. AssemblyBio shallSubject to Sections 7.2 and 7.3(b), Zymeworks shall have the right, either by itself or through a CMOThird Party contract manufacturer, Manufacture to manufacture and supply to BeiGene all Licensed Products required by BeiGene for Development use in the Territory under the Territory Development Plan and for BeiGene’s Development-related responsibilities under the Global Development Plan, subject including the conduct of any ZW25 Multi-Regional Clinical Study. Subject to Section 7.2, the terms and conditions of the Clinical Supply Agreement. The Parties shall use Commercially 62 Competitive Information – Commercially Sensitive Terms. Reasonable Efforts to enter into an agreement governing the supply by AssemblyBio Zymeworks of such Licensed Products for such Development use by BeiGene (“Clinical Supply Agreement”) within [* * …***…] after following the Effective Date, pursuant to which BeiGene shall purchase its clinical requirements for Licensed Product in the Territory from AssemblyBio. AssemblyBio which:63 (i) Zymeworks shall supply the Licensed Products pursuant to this Section 7.2(a7.3(a) in [* * *] at a transfer price [* * …***…]. AssemblyBio Zymeworks shall invoice BeiGene for the Licensed Products [* * *] Product upon delivery in accordance with this Section 7.2 7.3 and BeiGene shall, subject to the terms of the Clinical Supply Agreement, pay the undisputed invoiced amounts within [* * …***…] after the date of such invoice. Notwithstanding the foregoing, in the event AssemblyBio Zymeworks will incur, [* * …***…], any advance fee or charge, including a slot reservation fee, advance raw material charges, or other similar fees or charges for Manufacture of Licensed Product solely for BeiGene, AssemblyBio Zymeworks may invoice BeiGene for such fee or charge, as applicable, charge [* * …*], **…] and BeiGene shall, pay such invoiced amounts within [* * …***…] after the date of receipt of such invoice. Amounts paid by BeiGene for clinical supply invoice.64 (ii) Delivery of Licensed Products under this Agreement supplied by Zymeworks for Development will be included among Development made Ex Works (Incoterms 2010) Zymeworks’ or its contract manufacturer’s facility. BeiGene shall be responsible for obtaining all licenses or other authorizations for the exportation and Regulatory Costs importation of such Licensed Product, and shared by BeiGene shall contract for shipment and insurance of such Licensed Product from Zymeworks’ or its contract manufacturer’s facility, […***…]. BeiGene shall also be responsible for the Parties in accordance with Section 5.4.clinical packaging, labeling, QC/QA/QP release, storage, customs clearance and distribution of such Licensed Product, […***…].65