Common use of Initial Development Activities Clause in Contracts

Initial Development Activities. Ablynx shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities. Ablynx shall provide AbbVie with monthly high-level status reports noting project critical path activities, risks and mitigation plans. If Ablynx is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within […***…] after written notice thereof from AbbVie, AbbVie shall have the right, at AbbVie’s sole election, and without limitation to any other right or remedy available to AbbVie, to assume and complete some or all of such Initial Development Activities. The Parties acknowledge and agree that in the event AbbVie assumes some or all of such Initial Development Activities, given the underlying material breach, AbbVie, after using Commercially Reasonable Efforts, may not be able to complete such Initial Development Activities in accordance with the Initial Development Plan and Budget. If AbbVie so elects to assume and complete any of the Initial Development Activities, to the extent requested by AbbVie (i) Ablynx shall assign to AbbVie any or all Third Party agreements relating to such Initial Development Activities (including agreements with contract research organizations, clinical sites, investigators and manufacturing providers), and (ii) AbbVie shall use Commercially Reasonable Efforts to perform the Initial Development Activities that AbbVie has elected to assume and complete under this Section 3.1.2. In such event, with respect to all such Initial Development Activities that involve Clinical Studies, at AbbVie’s option, Ablynx shall either (i) end such Clinical Studies with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment with previously enrolled subjects, or (ii) transfer Control to AbbVie or its designee of such Clinical Studies and cooperate with AbbVie to ensure a smooth and orderly transition thereof that will not involve any disruption of such Clinical Studies. In the event AbbVie elects to assume and complete Initial Development Activities under this Section 3.1.2, Ablynx shall bear the responsibility for all costs and expenses of the Initial Development Activities (including supply costs and any costs associated with the transfer), regardless of which Party undertakes such Initial Development Activities. The Parties acknowledge and agree that with respect to any actual, alleged or potential material breach relating to Ablynx’s performance of the Initial Development Activities, AbbVie shall not issue a Default Notice in respect of such material breach before such actual, alleged or potential material breach has been discussed in good faith by the JDC pursuant to the provisions of Section 2.2 and the JSC pursuant to the provisions of Section 2.4; provided, that the JSC shall utilize all reasonable measures to expedite a resolution of such actual, alleged or potential material breach, including promptly convening an ad hoc JSC meeting. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Initial Development Activities. Ablynx shall perform the Initial Development ActivitiesSubject to Section 8.4, and shall do so in accordance with the Initial Development Plan and Budget by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities. Ablynx shall provide AbbVie with monthly highI-level status reports noting project critical path activities, risks and mitigation plans. If Ablynx is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within […***…] after written notice thereof from AbbVie, AbbVie Mab shall have the rightsole right and responsibility, at AbbVie’s its sole election, cost and without limitation to any other right or remedy available to AbbVieexpense, to assume prepare, obtain and complete some or maintain all of such Initial Development Activities. The Parties acknowledge and agree that in the event AbbVie assumes some or all of such Initial Development Activities, given the underlying material breach, AbbVie, after using Commercially Reasonable Efforts, may not be able to complete such Initial Development Activities in accordance with the Initial Development Plan and Budget. If AbbVie so elects to assume and complete any of the Initial Development Activities, to the extent requested by AbbVie (i) Ablynx shall assign to AbbVie any or all Third Party agreements relating to such Initial Development Activities INDs (including agreements with contract research organizations, clinical sites, investigators and manufacturing providers), and (iiCTA Approvals) AbbVie shall use Commercially Reasonable Efforts necessary to perform the Initial Development Activities that AbbVie has elected and to assume and complete under this Section 3.1.2. In such event, conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that the form and content of all such Initial Development Activities that involve Clinical StudiesINDs and related communications shall be subject to the review and approval of AbbVie (such approval not to be unreasonably withheld, at AbbVie’s optionconditioned or delayed). Without limitation to the foregoing, Ablynx in no event shall either (i) end such Clinical Studies I-Mab engage in material communications with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment with previously enrolled subjects, or (ii) transfer Control to AbbVie or its designee of such Clinical Studies and cooperate with AbbVie to ensure a smooth and orderly transition thereof that will not involve any disruption of such Clinical Studies. In the event AbbVie elects to assume and complete Initial Development Activities under this Section 3.1.2, Ablynx shall bear the responsibility for all costs and expenses of Regulatory Authority regarding the Initial Development Activities for a Licensed Compound or Licensed Product (a) in writing, without AbbVie’s prior written approval of the form and content of such written communication or (b) orally (including supply costs in connection with any meeting, conference or discussion) with any Regulatory Authority other than with AbbVie’s prior written approval of the forum, form and any costs associated with the transfercontent of such oral communication, in each case ((a) and (b)), regardless such approval not to be unreasonably withheld, conditioned or delayed. For clarity, the foregoing shall not apply to informal or non-substantive communications with Regulatory Authorities. I-Mab shall provide access to interim drafts of which Party undertakes such Initial Development Activities. The Parties acknowledge INDs and agree that with respect communications to AbbVie via the access methods (such as secure databases) mutually agreed by the Parties, for AbbVie’s review, comment and approval, sufficiently in advance of submitting such INDs and communications to any actual, alleged or potential material breach relating Regulatory Authority so as to Ablynx’s performance of the Initial Development Activities, allow for a reasonable opportunity for AbbVie to review. AbbVie shall not issue a Default Notice provide written comments, if any, and, confirm whether such approval right is granted, in respect each case, within [Redacted] of receipt of such material breach before access (or such actualshorter period as is reasonably required under the circumstances). Without limiting AbbVie’s approval rights under this Section 8.2.1, alleged I-Mab shall, and shall cause its Affiliates to, reasonably consider any such comments of AbbVie into any such IND or potential material breach has been discussed in good faith by the JDC pursuant to the provisions of Section 2.2 and the JSC pursuant to the provisions of Section 2.4; provided, that the JSC shall utilize all reasonable measures to expedite a resolution of such actual, alleged or potential material breach, including promptly convening an ad hoc JSC meeting. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDEDcommunication.

Initial Development Activities. Ablynx shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities. Ablynx shall provide AbbVie with monthly high-level status reports noting project critical path activities, risks and mitigation plans. If Ablynx is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within […***…] after written notice thereof from AbbVie, AbbVie shall have the right, at AbbVie’s sole election, and without limitation to any other right or remedy available to AbbVie, to assume and complete some or all of such Initial Development Activities. The Parties acknowledge and agree that in the event AbbVie assumes some or all of such Initial CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Development Activities, given the underlying material breach, AbbVie, after using Commercially Reasonable Efforts, may not be able to complete such Initial Development Activities in accordance with the Initial Development Plan and Budget. If AbbVie so elects to assume and complete any of the Initial Development Activities, to the extent requested by AbbVie (i) Ablynx shall assign to AbbVie any or all Third Party agreements relating to such Initial Development Activities (including agreements with contract research organizations, clinical sites, investigators and manufacturing providers), and (ii) AbbVie shall use Commercially Reasonable Efforts to perform the Initial Development Activities that AbbVie has elected to assume and complete under this Section 3.1.2. In such event, with respect to all such Initial Development Activities that involve Clinical Studies, at AbbVie’s option, Ablynx shall either (i) end such Clinical Studies with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment with previously enrolled subjects, or (ii) transfer Control to AbbVie or its designee of such Clinical Studies and cooperate with AbbVie to ensure a smooth and orderly transition thereof that will not involve any disruption of such Clinical Studies. In the event AbbVie elects to assume and complete Initial Development Activities under this Section 3.1.2, Ablynx shall bear the responsibility for all costs and expenses of the Initial Development Activities (including supply costs and any costs associated with the transfer), regardless of which Party undertakes such Initial Development Activities. The Parties acknowledge and agree that with respect to any actual, alleged or potential material breach relating to Ablynx’s performance of the Initial Development Activities, AbbVie shall not issue a Default Notice in respect of such material breach before such actual, alleged or potential material breach has been discussed in good faith by the JDC pursuant to the provisions of Section 2.2 and the JSC pursuant to the provisions of Section 2.4; provided, that the JSC shall utilize all reasonable measures to expedite a resolution of such actual, alleged or potential material breach, including promptly convening an ad hoc JSC meeting. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Initial Development Activities. Ablynx Licensor shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget (including the budget set forth therein, subject to Section 3.4.4) by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities. Ablynx shall provide AbbVie with monthly high-level status reports noting project critical path activities, risks Activities successfully and mitigation planspromptly. If Ablynx Licensor is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within […***…] days after written notice thereof from AbbVieLicensee, AbbVie Licensee shall have the right, at AbbVieLicensee’s sole election, and without limitation to any other right or remedy available to AbbVie, to assume and complete some or all of such Initial Development Activities. The Parties acknowledge and agree that in the event AbbVie assumes some or all of such Initial Development Activities, given the underlying material breach, AbbVie, after using Commercially Reasonable Efforts, may not be able to complete such Initial Development Activities in accordance with the Initial Development Plan and Budget. If AbbVie Licensee so elects to assume and complete any of the Initial Development Activities, to the extent requested by AbbVie (i) Ablynx Licensee in writing, Licensor shall assign to AbbVie Licensee any or all Third Party agreements relating to such Initial Development Activities (including agreements with contract research organizations, clinical sites, investigators sites and manufacturing providersinvestigators), and (ii) AbbVie shall use Commercially Reasonable Efforts to perform the Initial Development Activities that AbbVie has elected to assume and complete under this Section 3.1.2. In such event, with respect to all such Initial Development Activities that involve Clinical Studies, at AbbVieLicensee’s option, Ablynx Licensor shall either (i) end such Clinical Studies clinical trials with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment with previously enrolled subjects, subjects or (ii) transfer Control control to AbbVie Licensee or its designee of such Clinical Studies clinical trials and cooperate with AbbVie Licensee to ensure a smooth and orderly transition thereof that will not involve any disruption of such studies. Licensee understands and acknowledges that Licensor cannot guarantee the outcome or results of any studies within the Initial Development Plan. The Parties agree that the results of prior Clinical StudiesStudies included in the Initial Development Plant may affect the desirability of commencing later Clinical Studies included in the Initial Development Plan, and my require an amendment (including a Material Amendment) to the Development Plan. If the JDC is unable to agree upon whether any such amendment is required or the content of such amendment, the dispute shall be resolved pursuant to Section 13.6. In the event AbbVie elects the JDC cannot agree whether a proposed amendment is a Material Amendment, such dispute shall be resolved pursuant to assume Section 13.6, and complete Initial Development Activities under this Section 3.1.2until such resolution, Ablynx Licensor shall bear the responsibility for all costs and expenses of continue to carry out the Initial Development Activities (including supply costs and any costs associated with the transfer)Plan then in effect, regardless of which Party undertakes such Initial Development Activities. The Parties acknowledge and agree that with respect to any actual, alleged or potential material breach relating to Ablynx’s performance of the Initial Development Activities, AbbVie but shall not issue a Default Notice in respect of such material breach before such actual, alleged or potential material breach has been discussed in good faith by the JDC pursuant be required to the provisions of Section 2.2 and the JSC pursuant to the provisions of Section 2.4; provided, that the JSC shall utilize all reasonable measures to expedite a resolution of such actual, alleged or potential material breach, including promptly convening an ad hoc JSC meeting. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDEDcommence any new Clinical Study.