Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. The following shall apply with respect regulatory activities relating to each Collaboration Program: (a) Subject to Section 4.4.2(c) below, the then-Regulatory Lead shall have the lead role and responsibility with respect to the preparation, obtaining and maintenance of all Regulatory Documentation necessary to perform the applicable activities under the applicable Development Plan or Commercialization Plan. The Non-Regulatory Lead shall support the Regulatory Lead, as may be reasonably necessary, in the preparation, obtaining and maintenance of such Regulatory Documentation, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain such Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, to the extent the Regulatory Lead is not the same Party as the Manufacturing Lead, the Manufacturing Lead shall prepare the CMC Module 3 of the Common Technical Document in English for the Optioned Product, and the Regulatory Lead will modify as appropriate, such module for use in Regulatory Approvals in the Territory. Notwithstanding anything to the contrary in this Section 4.4.2(a), during the period of time when (i) Denali is the Regulatory Lead pursuant to Section 4.4.1(a), Takeda shall, to the extent permissible under Applicable Law and notwithstanding Section 4.4.2(d), have the right to interact directly with the respective Regulatory Authority on an interaction directly related to the filing and preparation of Regulatory Documentation for the Late Stage Development Activities, subject to prior notification and coordination with Denali, and (ii) Takeda is the Regulatory Lead pursuant to Section 4.4.1(b), if Denali is to be the Commercial Lead in the United States with respect to a Collaboration Program, (A) Denali shall, to the extent permissible under Applicable Law, have the right to interact directly with the FDA on the Product Labeling for each Optioned Product in such Collaboration Program, subject to prior notification and coordination with Takeda, (B) Takeda shall not conduct any scheduled discussions, meetings, and conferences with the FDA on Product Labelling for Optioned Products included in such Collaboration Program without prior notification and coordination with Denali, and (C) notwithstanding Section 4.4.2(d), Denali shall have the right to have [***], or more if determined by the JPT, participate in all scheduled discussions, meetings, and conferences with the FDA on Product Labelling for each Optioned Product in such Collaboration Program for which Denali is to be the Commercial Lead in the United States pursuant to Section 4.4.2(d). Confidential 47 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. (b) All Regulatory Documentation to the extent relating to an Optioned Biologic or Optioned Product with respect to an Indication within such Collaboration Program shall be owned by, and shall be the sole property and held in the name of the then-Regulatory Lead for such Indication. All Regulatory Documentation relating to the Optioned Biologics or Optioned Products that is not specific to any particular Indication shall be owned by, and shall be the sole property and held in the name of the then-Regulatory Lead for first Indication for which the applicable Optioned Biologics or Optioned Product received Regulatory Approval, or if no such Regulatory Approval has been obtained, the most advanced Indication with respect to the applicable Optioned Biologic or Optioned Product. In the event one Party replaces the other Party as the Regulatory Lead, the Parties shall, in manner consistent with the Transition Plan: (i) transition to such Regulatory Lead all applicable INDs for an Optioned Product; (ii) hereby assign to such Regulatory Lead all of such other Party’s right, title and interest in and to all Regulatory Documentation (to the extent consistent with the above provisions of this Section 4.4.2(b) regarding ownership of such Regulatory Documentation) in the Territory and Controlled by such other Party during the Term; and (iii) duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under, or as such Regulatory Lead may reasonably request to carry out more effectively the purpose of this Section 4.4.2(b). (c) The Regulatory Lead in a Major Market for the applicable Optioned Biologics and Optioned Products shall provide the Non-Regulatory Lead with an opportunity to review and comment on all INDs, pre-meeting submissions, Drug Approval Applications, Product Labeling, material labeling supplements, Regulatory Authority meeting requests, core data sheets and other material regulatory submissions, in each case, in the Major Markets (collectively, “Major Regulatory Filings”). The Regulatory Lead shall consider in good faith the Non-Regulatory Lead’s comments and use reasonable efforts to implement such comments. The Regulatory Lead shall provide access to interim drafts of such Major Regulatory Filings to the Non-Regulatory Lead via the access methods (such as secure databases) established by the JPT, and the Non-Regulatory Lead shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within [***] Business Days (or [***] Business Days in the case of Drug Approval Applications), or such other period of time mutually agreed to by the Parties. In the event that a Regulatory Authority in the Territory establishes a response deadline for any such Major Regulatory Filing (or material action with respect thereto) shorter than such [***]-Business Day period (or [***]-Business Day period in the case of Drug Approval Applications), the Parties shall work cooperatively to ensure the Non-Regulatory Lead has a reasonable opportunity for review and comment within such deadlines. The Regulatory Lead shall consider in good faith any such comments of the Non-Regulatory Lead. Without limiting the foregoing, if Denali has elected to be the Commercial Lead in the United States for a particular Collaboration Program, all Drug Approval Applications to be filed in the United States for Optioned Products included in such Collaboration Program shall be drafted and prepared in close consultation with Denali.

Regulatory Activities. The following shall apply with respect regulatory activities relating to each Collaboration Program: (a) Subject As between the Parties, subject to Section 4.4.2(c3.7.1(b) belowand Section 3.7.1(d), Gilead shall be responsible for (i) preparing and filing all Regulatory Documentation, including the then-Regulatory Lead shall have IND filing for the lead role and responsibility with respect to the preparationfirst Licensed Product, (ii) obtaining and maintenance of maintaining all Regulatory Approvals for the Licensed Products and (iii) conducting communications with the Regulatory Authorities for the Licensed Products. Gilead shall prepare and file all clinical Regulatory Documentation necessary to perform the applicable activities under the applicable Development Plan or Commercialization PlanCollaboration Program, including the first IND filing for the first Licensed Product, in consultation with the JRDC. (b) As between the Parties, during the Collaboration Term, Precision shall be responsible for preparing all non-clinical and chemistry, manufacturing and control (CMC) reports, in each case, as reasonably required by Gilead, for inclusion in the first IND filing for the first Licensed Products. The Non-Regulatory Lead Precision shall prepare all such reports, and provide Gilead with copies of any such reports, in each case, in a timely manner to permit Gilead to make such IND filing without delay, which shall then be discussed in consultation with the JRDC. Without limiting the foregoing, Precision shall support the Regulatory Lead, Gilead as may be reasonably necessarynecessary in connection with Gilead’s preparation of clinical Regulatory Documentation under the Collaboration Program during the Collaboration Term pursuant to Section 3.7.1(a). The responsibilities, costs and expenses of Precision and its Affiliates under this Section 3.7.1(b) during the Collaboration Term will be set forth in the preparationCollaboration R&D Plan and Collaboration Budget and considered Development activities funded under Section 5.1.1. Thereafter, obtaining and maintenance of for any such Regulatory Documentationactivities, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain such Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, to the extent the Regulatory Lead is not the same Party as the Manufacturing Lead, the Manufacturing Lead shall prepare the CMC Module 3 of the Common Technical Document in English for the Optioned Product, and the Regulatory Lead will modify as appropriate, such module for use in Regulatory Approvals in the Territory. Notwithstanding anything to the contrary in this Section 4.4.2(a), during the period of time when (i) Denali is the Regulatory Lead pursuant to Section 4.4.1(a), Takeda shall, to the extent permissible under Applicable Law and notwithstanding Section 4.4.2(d), have the right to interact directly with the respective Regulatory Authority on an interaction directly related to the filing and preparation of Regulatory Documentation for the Late Stage Development Activities, subject to prior notification and coordination with Denali, Precision will [***] and (ii) Takeda is the Regulatory Lead pursuant to Section 4.4.1(b), if Denali is to be the Commercial Lead in the United States with respect to a Collaboration Program, (A) Denali shall, to the extent permissible under Applicable Law, have the right to interact directly with the FDA on the Product Labeling for each Optioned Product in such Collaboration Program, subject to prior notification and coordination with Takeda, (B) Takeda Gilead shall not conduct any scheduled discussions, meetings, and conferences with the FDA on Product Labelling for Optioned Products included in such Collaboration Program without prior notification and coordination with Denali, and (C) notwithstanding Section 4.4.2(d), Denali shall have the right to have [***]. (c) All Regulatory Documentation generated under this Agreement, or more if determined by the JPT, participate in all scheduled discussions, meetings, and conferences with the FDA on Product Labelling for each Optioned Product in such Collaboration Program for which Denali is to be the Commercial Lead including in the United States course of conducting the Collaboration Program, shall be owned by Gilead and held in the name of Gilead (or its designee). (d) Except as otherwise provided in the Supply Agreement or the Quality Agreement, with respect to each Licensed Product (i) Gilead shall have sole [***] Confidential treatment requested pursuant to Section 4.4.2(d). Confidential 47 *** Certain information in this agreement has been omitted and a request for confidential treatment filed separately with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. responsibility for attending all meetings (whether occurring in person, by telephone or other remote means) with applicable Regulatory Authorities; provided that, Gilead, where permitted by Applicable Law, shall permit a reasonable number of Precision employees to attend (A) each pre-IND meeting for the Licensed Product, (B) the end of phase 2 meeting for the Licensed Product with the FDA, and (C) any other meeting with FDA or EMA (or other competent Regulatory Authority in the United Kingdom) if such meeting has one or more items on the agenda directed toward the safety or delivery of ARC Nucleases; and (ii) Gilead shall have the sole right and responsibility to correspond with applicable Regulatory Authorities; provided that, Gilead, where permitted by Applicable Law, will provide draft communications with the FDA and EMA (or other competent Regulatory Authority in the United Kingdom) to Precision for review and comment to the extent it relates to the Gilead ARC Nuclease, the ARCUS Technology, ARCUS Assigned IP or any [***] indicates that text has been omitted and is the subject of a confidential treatment request. (b) All Regulatory Documentation to the extent relating licensed or sublicensed by Precision to an Optioned Biologic or Optioned Product with respect to an Indication within such Collaboration Program shall be owned byGilead, and shall be will consider Precision’s comments in good faith before submitting the sole property and held communications to the FDA or EMA (or other competent Regulatory Authority in the name of the then-Regulatory Lead for such IndicationUnited Kingdom). All Regulatory Documentation relating to the Optioned Biologics If either Party or Optioned Products that is not specific to its Affiliates or subcontractors receive any particular Indication shall be owned by, and shall be the sole property and held in the name of the then-Regulatory Lead for first Indication for which the applicable Optioned Biologics material written correspondence or Optioned Product received Regulatory Approval, or if no such Regulatory Approval has been obtained, the most advanced Indication with respect to the applicable Optioned Biologic or Optioned Product. In the event one Party replaces the other Party as communication from the Regulatory Lead, the Parties shall, in manner consistent with the Transition Plan: (i) transition to such Regulatory Lead all applicable INDs for an Optioned Product; (ii) hereby assign to such Regulatory Lead all of such other Party’s right, title and interest in and to all Regulatory Documentation (to the extent consistent with the above provisions of this Section 4.4.2(b) regarding ownership of such Regulatory Documentation) in the Territory and Controlled by such other Party during the Term; and (iii) duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under, or as such Regulatory Lead may reasonably request to carry out more effectively the purpose of this Section 4.4.2(b). (c) The Regulatory Lead in a Major Market for the applicable Optioned Biologics and Optioned Products shall provide the Non-Regulatory Lead with an opportunity to review and comment on all INDs, pre-meeting submissions, Drug Approval Applications, Product Labeling, material labeling supplements, Regulatory Authority meeting requests, core data sheets and other material regulatory submissions, in each case, Authorities in the Major Markets regarding (collectivelyx) in the case of Precision as the Party receiving such correspondence from the Regulatory Authorities, “Major the Licensed Products or any components thereof, or (y) in the case of Gilead as the Party receiving such correspondence from the Regulatory Filings”). The Regulatory Lead shall consider in good faith Authorities, the Non-Regulatory Lead’s comments and use reasonable efforts to implement such comments. The Regulatory Lead shall provide access to interim drafts of such Major Regulatory Filings to the Non-Regulatory Lead via the access methods (such as secure databases) established by the JPTGilead ARC Nuclease, and the Non-Regulatory Lead shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within any [***] Business Days (in-licensed by Precision or [***] Business Days in the case ARCUS Technology or ARCUS Assigned IP, such Party shall provide the other Party with access to or copies of Drug Approval Applications), all such material written or such other period of time mutually agreed to by the Parties. In the event that a Regulatory Authority in the Territory establishes a response deadline for any such Major Regulatory Filing (or material action with respect thereto) shorter than such [***]-Business Day period (or [***]-Business Day period in the case of Drug Approval Applications), the Parties shall work cooperatively to ensure the Non-Regulatory Lead has a reasonable opportunity for review and comment within such deadlines. The Regulatory Lead shall consider in good faith any such comments of the Non-Regulatory Lead. Without limiting the foregoing, if Denali has elected to be the Commercial Lead in the United States for a particular Collaboration Program, all Drug Approval Applications to be filed in the United States for Optioned Products included in such Collaboration Program shall be drafted and prepared in close consultation with Denalielectronic correspondence promptly after its receipt.

Regulatory Activities. The following shall apply with respect regulatory activities relating to each Collaboration Program: 1.1.1 Except as set forth in this Section 5.1.1 and Section 5.1.3, Genentech (aor its Affiliate or sublicensee) Subject to Section 4.4.2(c) below, the then-Regulatory Lead shall have the lead role sole right and responsibility with respect responsibility, at its cost and expense, to the preparationprepare and submit Regulatory Materials and to file for, obtaining and maintenance of all Regulatory Documentation necessary to perform the applicable activities under the applicable Development Plan or Commercialization Plan. The Non-Regulatory Lead shall support the Regulatory Lead, as may be reasonably necessary, in the preparation, obtaining and maintenance of such Regulatory Documentationobtain, and in maintain Regulatory Approvals (including the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain such Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, to the extent the Regulatory Lead is not the same Party as the Manufacturing Lead, the Manufacturing Lead shall prepare the CMC Module 3 setting of the Common Technical Document in English overall regulatory strategy therefor) for Collaboration Products. During the Optioned Product, and the Regulatory Lead will modify as appropriate, such module for use in Regulatory Approvals in the Territory. Notwithstanding anything to the contrary in this Section 4.4.2(a), during the period of time when (i) Denali is the Regulatory Lead pursuant to Section 4.4.1(a), Takeda shall, to the extent permissible under Applicable Law and notwithstanding Section 4.4.2(d), have the right to interact directly with the respective Regulatory Authority on an interaction directly related to the filing and preparation of Regulatory Documentation for the Late Stage Development Activities, subject to prior notification and coordination with Denali, and (ii) Takeda is the Regulatory Lead pursuant to Section 4.4.1(b), if Denali is to be the Commercial Lead in the United States with respect to a Collaboration Program, (A) Denali shall, to the extent permissible under Applicable Law, have the right to interact directly with the FDA on the Product Labeling for each Optioned Product in such Collaboration Program, subject to prior notification and coordination with Takeda, (B) Takeda shall not conduct any scheduled discussions, meetings, and conferences with the FDA on Product Labelling for Optioned Products included in such Collaboration Program without prior notification and coordination with Denali, and (C) notwithstanding Section 4.4.2(d), Denali shall have the right to have [***], or more if determined by the JPT, participate in all scheduled discussions, meetings, and conferences with the FDA on Product Labelling for each Optioned Product in such Collaboration Program for which Denali is to be the Commercial Lead in the United States pursuant to Section 4.4.2(d). Confidential 47 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted period following the Royalty Conversion Effective Date, if and is the subject of a confidential treatment request. (b) All Regulatory Documentation to the extent requested by Genentech, Xencor shall provide up to [***] of consulting support for obtaining such Regulatory Approvals for the Collaboration Products, including providing information, documents or other materials (for clarity, including CMC- related information, documents or materials) required by Applicable Law for inclusion in or in support of Regulatory Materials. For clarity, Xencor’s costs in connection with the foregoing consulting support shall be Support Costs. 1.1.2 Except as set forth in Section 5.1.3, all Regulatory Materials relating to an Optioned Biologic or Optioned Product with respect to an Indication within such the Collaboration Program Products shall be owned by, and shall be the sole property and held in the name of the then-Regulatory Lead for such Indicationof, Genentech or its designated Affiliate, sublicensee or designee. All Regulatory Documentation Approvals and Product Labeling relating to the Optioned Biologics or Optioned Collaboration Products that is not specific to any particular Indication shall be owned by, and shall be the sole property and held in the name of, Genentech or its designated Affiliate, sublicensee or designee. 1.1.3 If Genentech declines to conduct a Proposed Study in accordance with Section 4.2.1, and Xencor has the right to conduct such Proposed Study pursuant to Section 4.2.3, then Xencor may conduct such Proposed Study as a Xencor Study in accordance with Section 4.2.4 under an IND owned by Xencor (“Xencor IND”). Genentech shall allow Xencor to cross reference the IND owned by Genentech for the relevant Collaboration Product for purposes of such Xencor IND. Genentech will, upon request, provide a letter to the then-Regulatory Lead for first Indication for which FDA or the applicable Optioned Biologics Regulatory Authority confirming such right of reference. In any communications and interactions with a Regulatory Authority that are undertaken in connection with such Xencor Study or Optioned Product received Xencor IND, Xencor and its authorized agents shall take into consideration and in no case intentionally materially harm the overall relationship with Regulatory Approval, or if no such Regulatory Approval has been obtained, the most advanced Indication Authorities with respect to the applicable Optioned Biologic or Optioned ProductCollaboration Products. In the event one Party replaces that Xencor conducts a Xencor Study, Xencor shall grant Genentech a right of cross reference to safety data, non-clinical data, CMC data and any special population data contained in the other Party as relevant Xencor IND. Xencor will provide a letter to the FDA or the applicable Regulatory LeadAuthority confirming such right of reference. Xxxxxx agrees that in the event it desires to obtain Regulatory Approval for a Collaboration Product investigated in a Xencor Study, the Parties shallwill work together so that Genentech, in manner consistent with the Transition Plan: rather than Xencor, will submit any necessary Marketing Approval Applications. Genentech shall use Commercially Reasonable Efforts to submit such Marketing Approval Applications as soon as practicable. Xencor shall not file a Marketing Approval Application for a Collaboration Product (iexcluding Termination Products) transition to such Regulatory Lead all applicable INDs for an Optioned Product; (ii) hereby assign to such Regulatory Lead all of such other Partywithout Genentech’s right, title and interest in and to all Regulatory Documentation (to the extent consistent with the above provisions of this Section 4.4.2(b) regarding ownership of such Regulatory Documentation) in the Territory and Controlled by such other Party during the Term; and (iii) duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under, or as such Regulatory Lead may reasonably request to carry out more effectively the purpose of this Section 4.4.2(b)prior written consent. (c) The 1.1.4 All communications with and material Regulatory Lead Materials submitted to any Regulatory Authority in a Major Market for connection with any Xencor Study shall be coordinated between the applicable Optioned Biologics and Optioned Products Parties to ensure consistency across the Parties’ regulatory activities. In particular, Xencor shall provide the Non-Regulatory Lead Genentech with an opportunity to review copies of draft and comment on all filed INDs, pre-meeting submissions, Drug Marketing Approval Applications, Product Labeling, material labeling supplements, Regulatory Authority meeting requests, Regulatory Authority advice (including scientific advisory packages), core data sheets and any other material regulatory submissionssubmissions and communications (including written summaries of oral communications proposed or conducted by or on behalf of Xencor) with any Regulatory Authority pertaining to a Xencor Study sufficiently in advance, in each casewhere reasonable, in for the Major Markets (collectively, “Major Genentech to comment on any such Regulatory Filings”)Materials or communications with any Regulatory Authority. The Regulatory Lead Xencor shall consider give due consideration in good faith the Non-to any comments provided by Genentech in relation to such Regulatory Lead’s comments and use reasonable efforts to implement such comments. The Materials or communications with any Regulatory Lead shall provide access to interim drafts of such Major Regulatory Filings to the Non-Regulatory Lead via the access methods (such as secure databases) established by the JPT, and the Non-Regulatory Lead shall provide its comments on the final drafts of such Major Regulatory Filings or of proposed material actions within [***] Business Days (or [***] Business Days in the case of Drug Approval Applications), or such other period of time mutually agreed to by the Parties. In the event that a Regulatory Authority in the Territory establishes a response deadline for any such Major Regulatory Filing (or material action with respect thereto) shorter than such [***]-Business Day period (or [***]-Business Day period in the case of Drug Approval Applications), the Parties shall work cooperatively to ensure the Non-Regulatory Lead has a reasonable opportunity for review and comment within such deadlines. The Regulatory Lead shall consider in good faith any such comments of the Non-Regulatory Lead. Without limiting the foregoing, if Denali has elected to be the Commercial Lead in the United States for a particular Collaboration Program, all Drug Approval Applications to be filed in the United States for Optioned Products included in such Collaboration Program shall be drafted and prepared in close consultation with DenaliAuthority.