Common use of Global Development Plan Clause in Contracts

Global Development Plan. Except with respect to [***]as specified below, Company shall use Commercially Reasonable Efforts to conduct the Development of the Products for the Territory in accordance with the Global Development Plan, at its own expense (subject to MacroGenics’ sharing of expenses upon its exercise of the Co-Funding Option). Company shall have the right to make amendments to the Global Development Plan, which shall be consistent with Company’s Development obligations set forth in Section 4.2(a), and each amended Global Development Plan shall include all material Development activities anticipated to be required to obtain Regulatory Approval for Products in [***], as well as timelines regarding such activities, including the plans and timelines for preparing the necessary Regulatory Materials. The Global Development Plan shall include any Development activities with respect to [***] that Company elects to conduct, provided that Company shall have no obligation to conduct Development or to seek Regulatory Approval for Products in [***]. Beginning with the delivery of the Co-Funding Materials and continuing through the Co-Funding Option Deadline (if MacroGenics does not exercise the Co-Funding Option) and the Co-Funding Termination Date (if MacroGenics exercises the Co-Funding Option), Company shall update the Global Development Plan to include a then-current, non-binding budget for any Global Development Costs. During the Co-Funding Term, Company shall update and amend, as appropriate, the then-current Global Development Plan and shall submit such updates and/or amendments for review to the JSC. While the Global Development Plan shall not require the approval of the JSC, Company shall review and consider all comments to the Global Development Plan received from MacroGenics at the JSC in good faith. Company will consider including, in the Global Development Plan, Clinical Trials using the Initial Product [***], to the extent that Company reasonably determines that such Clinical Trials are feasible from a medical, scientific, regulatory and commercial perspective. The Parties acknowledge and agree that Company’s ability to conduct such Clinical Trials may be subject to [***] and that Company shall have no obligation to conduct such Clinical Trials unless the conduct of such Clinical Trials is [***].

Global Development Plan. Except with respect to [***]as specified belowA summary of Albireo’s Global Development Plan is set forth in Exhibit 4.2.1 (the “Global Development Plan”). The Global Development Plan will include, Company among other things, Phase III clinical studies, pre-clinical studies and CMC (chemistry, manufacturing, and controls) for obtaining Regulatory Approval in the US and the EU. Albireo shall use Commercially Reasonable Efforts to implement and conduct the development activities identified under the Global Development Plan. Albireo shall be responsible for all aspects of the Products for Global Development Plan and payment of all costs associated with the Territory development activities undertaken by Albireo in accordance with the Global Development Plan; provided, at its own expense (subject to MacroGenics’ sharing of expenses upon its exercise of however, that if such activities are also the Co-Funding Option). Company shall have the right to make amendments to the Global Development Plan, which shall be consistent with Company’s Development obligations set forth in Section 4.2(a), and each amended Global Development Plan shall include all material Development activities anticipated to be required to obtain Regulatory Approval for Products in undertaken by Albireo or its Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as well as timelines regarding amended. Affiliate in accordance with the Territory Development Plan and further are also (i) specific to or primarily related to obtaining Regulatory Approval in the Territory and (ii) specifically requested by Ajinomoto, Ajinomoto shall be responsible for all costs associated with such activities, including . Ajinomoto acknowledges that the plans and timelines for preparing the necessary Regulatory Materials. The Global Development Plan is subject to change (including, without limitation, the inclusion of additional studies) at any time by Albireo or its Licensees, in Albireo’s or such Licensee’s reasonable discretion; provided, however, that Albireo shall include any Development activities provide Ajinomoto with respect to [***] prior written notice of such changes and provided further that Company elects in the event that Ajinomoto notifies Albireo that it has made a good faith determination that such changes proposed to conductthe revised Global Development Plan will adversely affect Development, provided that Company shall have no obligation to conduct Development Manufacture or to seek Regulatory Approval for Products in [***]. Beginning with the delivery Commercialization of the Co-Funding Materials Albireo Compound and/or Product by Ajinomoto or its Sublicensees, Albireo shall consult with Ajinomoto and continuing through shall use Commercially Reasonable Efforts to implement all reasonable requests of Ajinomoto made to avoid or minimize the Co-Funding Option Deadline (if MacroGenics does not exercise adverse effects of such changes proposed to the Co-Funding Option) and the Co-Funding Termination Date (if MacroGenics exercises the Co-Funding Option), Company shall update revised Global Development Plan. Albireo will conduct its development activities under the Global Development Plan to include a then-currentin accordance with all Applicable Laws, non-binding budget for any Global Development Costs. During the Co-Funding TermGCP, Company shall update GLP and amend, as appropriate, the then-current Global Development Plan and shall submit such updates and/or amendments for review to the JSC. While the Global Development Plan shall not require the approval of the JSC, Company shall review and consider all comments to the Global Development Plan received from MacroGenics at the JSC in good faith. Company will consider including, in the Global Development Plan, Clinical Trials using the Initial Product [***], to the extent that Company reasonably determines that such Clinical Trials are feasible from a medical, scientific, regulatory and commercial perspective. The Parties acknowledge and agree that Company’s ability to conduct such Clinical Trials may be subject to [***] and that Company shall have no obligation to conduct such Clinical Trials unless the conduct of such Clinical Trials is [***]GMP.

Global Development Plan. Except with respect From time to [***]as specified belowtime, Company shall use Commercially Reasonable Efforts in order to conduct facilitate the Development of Products on a worldwide basis, a Party, acting through its representatives on the Products for Steering Committee, may propose that certain Development activities be performed in coordination between the Territory Parties in accordance with a written plan (the “Global Development Plan, at its own expense (subject to MacroGenics’ sharing of expenses upon its exercise of the Co-Funding Option”). Company shall have If approved by the right to make amendments to the Global Development Plan, which shall be consistent with Company’s Development obligations set forth in Section 4.2(a), and each amended Global Development Plan shall include all material Development activities anticipated to be required to obtain Regulatory Approval Steering Committee for Products in [***], as well as timelines regarding such activities, including the plans and timelines for preparing the necessary Regulatory Materials. The Global Development Plan shall include any Development activities with respect to [***] that Company elects to conduct, provided that Company shall have no obligation to conduct Development or to seek Regulatory Approval for Products in [***]. Beginning with the delivery of the Co-Funding Materials and continuing through the Co-Funding Option Deadline (if MacroGenics does not exercise the Co-Funding Option) and the Co-Funding Termination Date (if MacroGenics exercises the Co-Funding Option), Company shall update the Global Development Plan to include a then-current, non-binding budget for any Global Development Costs. During the Co-Funding Term, Company shall update and amend, as appropriate, the then-current Global Development Plan and shall submit such updates and/or amendments for review to the JSC. While the Global Development Plan shall not require the approval of the JSC, Company shall review and consider all comments to the Global Development Plan received from MacroGenics at the JSC in good faith. Company will consider including, inclusion in the Global Development Plan, Clinical Trials using such Development activities shall be incorporated in appropriate detail into a written amendment of the Initial Product [***]Global Development Plan. If not approved by the Steering Committee for inclusion in the Global Development Plan, to the extent that Company reasonably determines that such Clinical Trials are feasible from a medical, scientific, regulatory and commercial perspective. The Parties acknowledge and agree that Company’s ability to conduct such Clinical Trials may be subject to Development [***] Confidential Treatment Requested Confidential portion omitted and that Company filed separately with the Commission activities may be performed by a Party to the extent in accordance with Section 4.1 above. Except as expressly provided in this Agreement or agreed in writing by the Parties, each Party shall have no obligation be solely responsible for the expenses of performing its responsibilities under the Global Development Plan. 4.2.1. In addition, if ADLS or a Licensee decides to conduct such Clinical Trials unless the conduct any clinical studies with respect to any proposed future Product, ADLS shall give written notice of such Clinical Trials is [***]decision to Wyeth with a brief description of the proposed Product and clinical studies. If, after receipt of such notice, Wyeth notifies ADLS that Wyeth has a good faith interest in Developing and Commercializing such Product in the Territory, then such clinical studies shall be added to the Global Development Plan pursuant to an amendment of the Global Development Plan to be approved by the Steering Committee in accordance with this Agreement. 4.2.2. During the Term, the Global Development Plan may be updated from time to time as deemed necessary by the Steering Committee. 4.2.3. Each Party shall provide to the other Party or the Steering Committee, as appropriate, such information in its Control and relevant to the Development of Products as may be necessary or appropriate in connection with updating the Global Development Plan. Each modification or update of the Global Development Plan shall be subject to review and approval of the Steering Committee.