Common use of Interactions with Regulatory Authorities Clause in Contracts

Interactions with Regulatory Authorities. (i) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities. (ii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with prior notice, to the extent Ablynx has advance knowledge, of (a) any scheduled meeting, conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating to the Lead Compound (including interactions with Regulatory Authorities related to the pediatric plan), and (b) any inspection by any Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of AbbVie to be present at such meeting, conference, discussion or inspection as a silent observer. (iii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within […***…], or such other longer period of time as is mutually agreed to by the JDC. Ablynx shall consider in good faith any reasonable comments of AbbVie, provided they are made within the applicable timeframe established for AbbVie’s review in the prior sentence. If a Regulatory Authority establishes a response deadline for any Regulatory Documentation shorter than such […***…] period, Ablynx shall work cooperatively with AbbVie to ensure that AbbVie has a reasonable opportunity for review and comment within such deadline.

Interactions with Regulatory Authorities. Until assignment to Coherus of the Regulatory Materials that are the subject of Section 5.2 (i) Prior Assignment of Regulatory Materials), Junshi will have the joint right with Coherus to AbbVie proceeding with the In-Licensing, Ablynx shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) conduct communications with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard the Coherus Territory related to the Licensed Products that are the subject of those Regulatory Documentation for Materials, including all meetings, conferences, and discussions (including advisory committee meetings). Unless otherwise agreed by the Lead Compound Parties in writing or determined by the JDC, the Party designated as having control over and filing all updates to Regulatory Documentation, such as periodic or addecision-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided making authority with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities. (ii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with prior notice, preparing and submitting all regulatory filings related to the extent Ablynx Licensed Antibodies and Licensed Products under Section 5.3 (Regulatory Filings Control and Ownership) within or For the Coherus Territory or Junshi Territory (as applicable) also has advance knowledge, of (a) any scheduled meeting, conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating the sole right to the Lead Compound (including interactions conduct all communications with Regulatory Authorities related to the pediatric planapplicable Licensed Antibody(ies) or Licensed Product(s) for such territory, including all meetings, conferences, and discussions (including advisory committee meetings). The Party who controls such communications will disclose to the JDC within four (4) Business Days of such determination (a) any communications with a Regulatory Authority in the Coherus Territory that such Party reasonably determines would be likely to have a material impact on obtaining Regulatory Approval for a Licensed Product in the Coherus Territory, and (b) any inspection by any Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of AbbVie to be present at such meeting, conference, discussion or inspection as a silent observer. (iii) Prior to AbbVie proceeding communications with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within […***…], or such other longer period of time as is mutually agreed to by the JDC. Ablynx shall consider in good faith any reasonable comments of AbbVie, provided they are made within the applicable timeframe established for AbbVie’s review in the prior sentence. If a Regulatory Authority establishes a response deadline in the Coherus Territory that such Party reasonably determines indicates the Regulatory Authority will require any specific pre-approval or post-approval commitments or requirements for any Regulatory Documentation shorter than such […***…] period, Ablynx shall work cooperatively with AbbVie to ensure that AbbVie has a reasonable opportunity for review and comment within such deadline.Approval or Commercialization in the Coherus Territory. ​ ​ ​

Interactions with Regulatory Authorities. Insofar as it relates to the Ongoing Trials in the Territory and Licensee Added Trials (iif any) Prior to AbbVie proceeding with where Duality is the In-Licensingsponsor, Ablynx Duality shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) lead interactions with Regulatory Authorities in each country, responding the Territory; provided that JSC shall have final decision making authority in relation to inquiries of such interactions with Regulatory Authorities and Duality shall follow all instructions provided to it by the JSC in this regard and shall provide Licensee with regard (i) access to or copies of all material written or electronic communication received by Duality or its Affiliates from any Regulatory Authorities in the Regulatory Documentation for Territory and in the Lead Compound Retained Territory (if applicable), and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities. (ii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with prior notice, to the extent Ablynx has advance knowledge, copies of (a) any scheduled meeting, conference or discussion (including any advisory committee meetings) all meeting minutes with any Regulatory Authorities in the Territory and in the Retained Territory (if applicable). In addition, Duality shall provide Licensee with written notice of any scheduled material meeting, conference, or discussion with a Regulatory Authority relating related to Regulatory Approvals related to the Lead Compound Ongoing Trials. Licensee (including interactions or its designee) shall have the right to (i) attend and participate in all such meetings with Regulatory Authorities related to the pediatric planOngoing Trials), and all telephone conferences and preparation meetings of Duality or its Affiliates related to any such meeting, (ii) provide input on the regulatory filings in the Territory and in the Retained Territory (to the extent this impacts the position of Licensee in the Territory), and (biii) have final decision making authority in relation to any inspection by any unsettled matter between the Parties with respect to regulatory filings in the Territory. Subject to the foregoing, Licensee (and/or its Affiliates, or Sublicensees as applicable) shall have the sole right to conduct all communications with Regulatory Authority Authorities, including all meetings, conferences and discussions (including advisory committee meetings), with regard to the Licensed Compound and Licensed Products in the Territory, including in respect of Ablynx the Licensee Added Trials where Licensee (or any Third Party Provider its Affiliates or Sublicensees, as applicable) is the sponsor (if any). Without limited the forgoing, the Parties agree that they will collaborate with each other as necessary to ensure the successful progression of Ablynx interactions with Regulatory Authorities with respect to all trials relating to the Licensed Compound and Original ADC Licensed Products in the Territory and in the Retained Territory (to the extent Ablynx is aware this impacts the position of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of AbbVie to be present at such meeting, conference, discussion or inspection as a silent observer. (iii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within […***…], or such other longer period of time as is mutually agreed to by the JDC. Ablynx shall consider in good faith any reasonable comments of AbbVie, provided they are made within the applicable timeframe established for AbbVie’s review Licensee in the prior sentence. If a Regulatory Authority establishes a response deadline for any Regulatory Documentation shorter than such […***…] period, Ablynx shall work cooperatively with AbbVie to ensure that AbbVie has a reasonable opportunity for review and comment within such deadlineTerritory).

Interactions with Regulatory Authorities. 4.3.1 Subject to oversight of the applicable JMDRC, the applicable Regulatory Party for a country and a Product in the Field (ior its Affiliate or designee) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall have primary responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each the applicable country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation Materials for the Lead Compound such Product and filing all post-approval updates to Regulatory DocumentationMaterials, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation Materials that must be provided with respect to the Ablynx products, if any, such Product at periodic intervals to such Regulatory Authorities. The Non-Regulatory Party shall use [***] to cooperate with such Regulatory Party and to provide such assistance as reasonably requested by such Regulatory Party in connection with such activities. 4.3.2 In respect of the Regulatory Activities in the Co-Promotion Territory for which the Regulatory Party is responsible, the Non-Regulatory Party shall be permitted to have up to [***] of its designees attend all in person or other meetings with Regulatory Authorities (ii) Prior to AbbVie proceeding with or, in the In-Licensingcase of Regulatory Activities for the Pfizer Territory, Ablynx shall provide AbbVie with prior notice, [***] designee from [***] to the extent Ablynx has requested by [***] and required under the [***] Agreement), notice of which shall be given by such Regulatory Party to such Non-Regulatory Party sufficiently in advance knowledgethereof to allow such Non-Regulatory Party to prepare for and participate meaningfully in such meeting; provided, of (a) any scheduled however, that if prior to such meeting, conference or discussion (including any advisory committee meetings) such Regulatory Party cannot reasonably provide notice to such Non-Regulatory Party because the meeting must take place immediately, such Regulatory Party may act at its own discretion, in a manner consistent with any Regulatory Authority relating to the Lead Compound (including interactions with Regulatory Authorities related to the pediatric plan), applicable Joint Medical Affairs and (b) any inspection by any Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to Budget or the extent permitted by Development Component. The Regulatory Party shall promptly furnish the applicable Regulatory Authority, permit at least two (2) representatives other Party with copies of AbbVie to be present at such meeting, conference, discussion all substantive contact reports concerning substantive conversations or inspection as minutes from any substantive meetings with a silent observer. (iii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA)with respect to any IND related to a Product in the Field in the Co-Promotion Territory. Ablynx The Non-Regulatory Party for a country shall provide access to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within use […***…]] to support the Regulatory Party for such country in obtaining Regulatory Approval for such Product in such country and in the activities in support thereof, including providing necessary documents or other materials, including applicable CMC documentation and cGLP, cGCP, cGMP documentation and data, required by Applicable Law to obtain such other longer period Regulatory Approval, provided that, following Option Closing (if it occurs), in the case of time as is mutually agreed to by the JDC. Ablynx Pfizer Territory, Myovant shall consider in good faith be responsible for its costs of providing any reasonable comments of AbbVieassistance to Pfizer with respect to such support to enable Pfizer to obtain Regulatory Approval for the Oncology Product in the Major Countries, provided they are made within that, if Myovant is required to perform any activities or assistance beyond what is considered reasonable, the applicable timeframe established Parties shall agree in writing the cost to be reimbursed to Myovant for AbbVie’s review in the such activities or assistance prior sentence. If a Regulatory Authority establishes a response deadline for any Regulatory Documentation shorter than to such […***…] period, Ablynx shall work cooperatively with AbbVie to ensure that AbbVie has a reasonable opportunity for review and comment within such deadlinecosts being incurred by Myovant.

Interactions with Regulatory Authorities. (i) Prior Each Party shall provide the other Party with reasonable advance notice of meetings or other non-written communications with a Regulatory Authority regarding the Final Product prior to AbbVie proceeding with receipt of Regulatory Approval for such Final Product and the In-Licensing, Ablynx shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities opportunity to designate [***] representatives to participate in each country, responding such meeting or other non-written communication. In the event a Party intends to inquiries provide a submission or other written communication to a Regulatory Authority that relates the Final Product prior to receipt of Regulatory Approval for such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory DocumentationFinal Product, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of Party will provide the submissions of the Regulatory Documentation that must be provided other Party with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities. (ii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with prior notice, to the extent Ablynx has advance knowledge, of (a) any scheduled meetinga draft of such communication [***], conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating to the Lead Compound (including interactions with Regulatory Authorities related to the pediatric plan), and (b) any inspection by any Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of AbbVie to be present at such meeting, conference, discussion or inspection as a silent observer. (iii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review such draft and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access comments to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within Party […***…], or which comments such other longer period of time as is mutually agreed to by the JDC. Ablynx Party shall consider in good faith any reasonable comments of AbbViefaith; provided, provided they are made within the applicable timeframe established for AbbVie’s review in the prior sentence. If that if a Regulatory Authority establishes requests or requires a response deadline shorter timeframe for a response, then the other Party shall respond in a timeframe that enables such Party to meet the Regulatory Authority’s timeframe, and (c) with respect to submissions and written correspondence by Cxxx, the opportunity to approve (such approval not to be unreasonably delayed, conditioned or withheld) such submission and written correspondence with a Regulatory Authority to the extent that it relates to the Final Product for the DRL Field for use in the DRL Transferred Territory and/or the Product in the Territory. For the avoidance of doubt, Cxxx shall not submit a BLA for, or any other material or substantive submission or communication to a Regulatory Documentation shorter than Authority relating to, the Final Product in the DRL Field in the DRL Transferred Territory that has not been approved by DRL (such approval not to be unreasonably delayed, conditioned or withheld). Each Party shall provide the other Party with (i) a written summary of meetings or other non-written communications with a Regulatory Authority […***…] period], Ablynx shall work cooperatively with AbbVie and (ii) copies of any official correspondence to ensure that AbbVie has or from a reasonable opportunity Regulatory Authority [***], in each case of (i) and (ii) to the extent involving a clinical trial of, or otherwise related to, Final Product prior to receipt of Regulatory Approval for review and comment within such deadlineFinal Product.

Interactions with Regulatory Authorities. (i) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities. (ii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with prior notice, to the extent Ablynx has advance knowledge, of (a) any scheduled meeting, conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating to the Lead Compound (including interactions with Regulatory Authorities related to the pediatric plan), and (b) any inspection by any Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) relating to the conduct of the Initial Development Plan and Budget, and in each case, to the extent permitted by the applicable Regulatory Authority, permit at least two (2) representatives of AbbVie to be present at such meeting, conference, discussion or inspection as a silent observer. (iii) Prior to AbbVie proceeding with the In-Licensing, Ablynx shall provide AbbVie with an opportunity to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible for its review and comment, and AbbVie shall provide its comments on final drafts of such Regulatory Documentation within […***…], or such other longer period of time as is mutually agreed to by the JDC. Ablynx shall consider in good faith any reasonable comments of AbbVie, provided they are made within the applicable timeframe established for AbbVie’s review in the prior sentence. If a Regulatory Authority establishes a response deadline for any Regulatory Documentation shorter than such […***…] period, Ablynx shall work cooperatively with AbbVie to ensure that AbbVie has a reasonable opportunity for review and comment within such deadline. 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.

Interactions with Regulatory Authorities. 3.2.1. Subject to the remainder of this Section 3.2, during the Development Term, AgonOx (or Approved CRO), will (a) be the regulatory sponsor for the Phase I/II Clinical Trial and will have all responsibilities of a regulatory sponsor as specified in Applicable Law and (b) be primarily responsible for and control all communications and interactions with the Regulatory Authorities relating to the Phase I/II Clinical Trial and the IND for the Product and DP TIL for the Indication in the United States, including (i) Prior preparing, submitting and maintaining the CTAs required by Applicable Law to AbbVie proceeding with conduct the In-LicensingPhase I/II Clinical Trial in the countries for which Sites have been selected pursuant to Section 2.7, Ablynx shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the Ablynx products, if any, at periodic intervals to such Regulatory Authorities. (ii) Prior to AbbVie proceeding with preparing, submitting and maintaining the In-Licensing, Ablynx shall provide AbbVie with prior notice, to IND for the extent Ablynx has advance knowledge, of Product and DP TIL for the Indication in the United States; provided that (aA) any scheduled meeting, conference or discussion (including any advisory committee meetings) with any Regulatory Authority relating to the Lead Compound (including all such interactions with Regulatory Authorities related shall be conducted in a manner consistent with the Regulatory Strategy; (B) at AgonOx (or Approved CRO)’s request, Phio will reasonably cooperate with AgonOx (or Approved CRO) with respect to the pediatric plan), communications and (b) any inspection by any interactions with Regulatory Authority of Ablynx or any Third Party Provider of Ablynx (to the extent Ablynx is aware of any such inspection) Authorities relating to the conduct Phase I/II Clinical Trial and the IND for the Product for the Indication in the United States, including the preparation of the Initial CMC portion of such IND in accordance with Section 3.2.2; (C) Phio will provide to AgonOx (or Approved CRO) all relevant information, or the requisite right of reference to such information, for any CTAs for the Product; (D) Phio (or any of its Affiliates) will be permitted to appoint up to three (3) observers to attend any meetings with Regulatory Authorities relating to the Phase I/II Clinical Trial or the Product, as applicable; (E) AgonOx shall provide Phio with copies of any material correspondence or other documents received by AgonOx (or Approved CRO) from applicable Regulatory Authorities relating to the Phase I/II Clinical Trial or the Product, as applicable, within three (3) Business Days following AgonOx’s receipt thereof; and (F) during the Development Plan Term, AgonOx shall establish and Budgetmaintain, and shall require its Affiliates and Approved CROs conducting AgonOx Development Activities to establish and maintain, a log of all submissions to, and communications with, Regulatory Authorities related the Phase I/II Clinical Trial. 3.2.2. In connection with AgonOx’s (or an Approved CRO’s) preparation and submission of the CTAs for the Phase I/II Clinical Trial, Phio will in a timely manner (a) either (i) provide to AgonOx or its designated Affiliate an appropriate right of reference to the CMC Information for INTASYL PH-762 , and/or (ii) provide a copy of the CMC Information for INTASYL PH-762 to AgonOx, in each case, to the extent permitted by necessary for the applicable Regulatory Authoritysubmission of each CTA (or any update to such CTA, permit at least as applicable), and (b) prepare and provide to AgonOx within two weeks of a request from AgonOx the CMC portion (2or any update to such CMC portion) representatives of AbbVie the IND for the Product for the Indication in the United States (or an appropriate right of reference to be present at such meeting, conference, discussion or inspection as a silent observerinformation) in sufficient detail to support the submission of such IND; in each case subject to the terms of Sections 7.1 and 7.2. 3.2.3. Except as otherwise provided in this Article 3, as between the Parties, (iiia) Prior to AbbVie proceeding AgonOx or its applicable Affiliate (or Approved CRO) will be solely responsible for all communications and interactions with the InRegulatory Authorities with respect to the Phase I/II Clinical Trial or the Product, (b) Phio will not communicate with Regulatory Authorities directly with regard to the Phase I/II Clinical Trial without the prior consent of AgonOx (or Approved CRO); provided that during the Development Term, Phio will be permitted to appoint up to three (3) observers to the pre-Licensing, Ablynx shall provide AbbVie with an opportunity IND Meeting and any other meeting between AgonOx (or Approved CRO) and the Regulatory Authorities in the United States to review and comment on all Regulatory Documentation, including substantive correspondence, INDs, CTAs, Regulatory Authority the extent such meeting requests and briefing packages (e.g., EMA and FDA). Ablynx shall provide access relates to interim drafts of such Regulatory Documentation to AbbVie via access methods (such as secure databases) established by the JDC as soon as reasonably possible Product for its review and commentthe Indication in the United States, and AbbVie shall (c) during the Development Term, AgonOx will provide its comments on final drafts Phio a copy of such Regulatory Documentation within […***…]any meeting minutes and regulatory interaction logs, in each case, solely to the extent (i) reasonably necessary for the conduct of the Phio’s Development Activities under and in accordance with the Clinical Development Plan or such other longer period of time as is mutually agreed (ii) specifically relating to by the JDC. Ablynx shall consider in good faith any reasonable comments of AbbVie, provided they are made within the applicable timeframe established for AbbVie’s review in the prior sentence. If a Regulatory Authority establishes a response deadline for any Regulatory Documentation shorter than such […***…] period, Ablynx shall work cooperatively with AbbVie to ensure that AbbVie has a reasonable opportunity for review and comment within such deadlinePhase I/II Clinical Trial.