Common use of Regulatory Assistance Clause in Contracts

Regulatory Assistance. (a) During each Program and for a period of [***] years following Completion, Fujifilm will provide all reasonably necessary assistance to aTyr in respect of aTyr’s regulatory filing activities for the applicable Drug Product or Process, subject to (except as may be expressly agreed in a Scope of Work) payment by aTyr of a reasonable commercial rate for such assistance and Fujifilm’s reasonable expenses. No advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Drug Product will receive regulatory approval. Fujifilm will provide an electronic (PDF) copy of any documents which may be reasonably required by aTyr in support of such regulatory filing activities. If aTyr requires copies of the laboratory notebooks, provision of these will be subject to agreement of an additional fee associated with copying. (b) aTyr shall have the sole right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and any Product and/or Drug Product, provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions solely to the extent relating to (i) the Facility; (ii) Fujifilm’s quality systems; (iii) any requirement imposed on Fujifilm by a Regulatory Authority or (iv) any other commitments made by Fujifilm prior to the commencement date of the applicable Program; (each a “Fujifilm Regulatory Responsibility”). aTyr shall therefore consult with Fujifilm in relation to in the Chemistry, Manufacturing and Controls (CMC) Clause of any submissions to Regulatory Authorities before submission to such Regulatory Authorities and aTyr shall not make any change to its regulatory filings, including without limitation its IND, which may in the reasonable judgment of aTyr have an impact on any such Fujifilm Regulatory Responsibility without [***] days written notification to Fujifilm.

Regulatory Assistance. (a) During each Program Programme and for a period of [***] years following Completion, Fujifilm will provide all reasonably necessary offer reasonable assistance to aTyr Checkmate in respect of aTyrCheckmate’s regulatory filing activities for the applicable Drug Product or Process, subject to (except as may be expressly agreed in a Scope of Work) payment by aTyr Checkmate of a reasonable commercial rate for such assistance and Fujifilm’s reasonable expenses. No advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Drug Product will receive regulatory approval. Fujifilm will provide an one electronic (PDF) copy of any documents which may be reasonably required by aTyr Checkmate in support of such regulatory filing activities. If aTyr Checkmate requires copies of the laboratory notebooks, provision of these will be subject to agreement of an additional fee associated with copying. (b) aTyr Checkmate shall have the sole right and responsibility for determining regulatory strategy, decisions and actions relating to each Program Programme, any Intermediate and any Product and/or Drug Product, provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions solely to the extent relating to (i) the Facility; (ii) Fujifilm’s quality systems; (iii) any requirement imposed on Fujifilm by a Regulatory Authority or (iv) any other commitments made by Fujifilm prior to the commencement date xxxx of the applicable Program; Programme which have an impact on a Programme and Intermediate and any Product and/or Drug Product (each a “Fujifilm Regulatory Responsibility”). aTyr , Checkmate shall therefore consult with Fujifilm in relation to in the Chemistry, Manufacturing and Controls (CMC) Clause section of any submissions to Regulatory Authorities before submission to such Regulatory Authorities and aTyr Checkmate shall not make any change to its regulatory filings, including without limitation its lnvestigational New Drug application (IND), which may in the reasonable judgment of aTyr have an impact Impact on any such Fujifilm Regulatory Responsibility without [***] days written notification to prior agreement with Fujifilm.

Regulatory Assistance. 5.6.1 The Customer shall provide Fujifilm with a copy of relevant parts of the Customer’s Chemistry, Manufacturing and Controls section of any submission to a Regulatory Authority supporting an Application made by the Customer’s for the applicable Drug Product (a) During each Program and for a period of whether the biologics license application or marketing authorisation application), the [***] years following CompletionReagent or the applicable Process, relevant parts being any part relating to Fujifilm’s manufacture of the Product (“CMC Section”) and any change thereto with enough time for Fujifilm to review and comment on the same before submission to such Regulatory Authority, provided, however, that Fujifilm shall use Commercially Reasonable Efforts to perform its review and that such review by Fujifilm shall not be unreasonably withheld. The Customer shall not submit a CMC Section without Fujifilm’s written approval in relation to any information regarding, or impacting, Fujifilm including any information regarding the Process, equipment, controls and analytics or any information provided to the Customer by Fujifilm related to or in accordance with the applicable Quality Agreement. If the documents or support required from Fujifilm pursuant to this clause 5.6.1 relate [***], then Fujifilm may [***]. 5.6.2 After the completion of the PPQ the Parties shall agree on the level of continuous process verification to be applied by Fujifilm (which may be itself subject to an agreement change). If the Customer requires any support in relation to regulatory documentation regarding continuous process verification over and above the level agreed, then Fujifilm may agree to provide that assistance [***]. 5.6.3 Fujifilm will provide all reasonably necessary assistance to aTyr in respect of aTyr’s regulatory filing activities for the applicable Drug Product or Process, subject to (except as may be expressly agreed in a Scope of Work) payment by aTyr of a reasonable commercial rate for such assistance and Fujifilm’s reasonable expenses. No advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Drug Product will receive regulatory approval. Fujifilm will provide an one electronic (PDF) copy of any documents which may be reasonably required by aTyr the Customer in support of such regulatory filing activitiesits Application. If aTyr the Customer requires copies of the laboratory notebooks, provision of these will be subject to discussion and agreement by the Parties and agreement of an additional fee associated with copying[***]. (b) aTyr 5.6.4 The Customer shall have the sole right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and any the Product and/or Drug Product, Product (including any BLA) and/or [***] Reagent subject to clause 5.6.5 and provided that Fujifilm shall have the right and responsibility for determining regulatory strategy, decisions and actions solely to the extent relating to to: (ia) the Facility; Facility (iiincluding in particular utilities and equipment); (b) Fujifilm’s quality systems; , policies and internal procedures; (iiic) any requirement imposed on Fujifilm by a Regulatory Authority or Authority; or (ivd) any other commitments made by Fujifilm prior to the commencement date of the applicable Program; Effective Date, (each a “Fujifilm Regulatory Responsibility”). 5.6.5 Fujifilm is obligated to support regulatory requirements and requests [***] Health Authority Requirements are in this context defined as direct legal requirements imposed on Customer in the respective region where non-compliance results in loss of license to operate or financial penalties due to non-compliance. aTyr shall therefore consult Health Authority Requests are defined as enquiries from Health Authorities in the respective region with Fujifilm in relation to regulatory submissions (including but not limited to marketing authorization applications, clinical trial applications, line extensions, variations and safety requests). Fujifilm Ascendis Commercial Supply Agreement 13 5.6.6 Fujifilm shall use its Commercially Reasonable Efforts to deliver any information/data required to support both Health Authority Requirements and Health Authority requests. Data should be delivered to Customer according to respective Health Authority controlled terms as applicable and where possible in structured format (in a suitable file format). 5.6.7 Fujifilm must make available any information/documentation/data required to support regulatory requirements/requests as soon as reasonably possible and no later than [***] following the Chemistry, Manufacturing first written enquiry from Customer. 5.6.8 The Customer acknowledges that Fujifilm’s Quality Assurance team reserves the right to Disposition Product and Controls (CMC) Clause of any submissions [***] Reagent to Regulatory Authorities before submission to such Regulatory Authorities and aTyr the Customer in accordance with the applicable Quality Agreement. 5.6.9 The Customer shall not make any change to its regulatory filings, including without limitation its INDany Application, which may in the reasonable judgment of aTyr have an impact on any such Fujifilm Regulatory Responsibility or Fujifilm’s performance of its obligations under this Agreement without [***] days prior written notification to Fujifilmagreement with Fujifilm in accordance with clause 0.