Common use of Recalls, Market Withdrawals or Corrective Actions Clause in Contracts

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone. Celgene shall, after reasonable consultation with Vividion, decide whether to conduct a recall, market withdrawal or similar action in such country or portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Product(s) in the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Co-Co Product in any portion of the Territory, or in the event either Party Celgene determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in portion of the Territory, then Jounce, as the Party notified of such recall, market withdrawal or similar action, or Celgene, as the Party that which desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephonetelephone or facsimile. Celgene shall, after reasonable consultation with VividionJounce, decide whether to conduct a recall, market withdrawal or similar action in such country or its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party Jounce will make available to the other PartyCelgene, upon request, all of such PartyJounce’s (and its Affiliates’) pertinent records that such other Party Celgene may reasonably request to assist such other Party Celgene in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Jounce Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Co-Co Product(s) in the Territory shall be (I) taken into account in determining either the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product or, in the applicable countryUnited States, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). D. The costs and expenses incurred after the Vividion Jounce Opt-Out Date for any recall, market withdrawal or similar action of any Shared Co-Co Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Jounce Opt-Out Date by the occurrence of the event, incident or circumstance that led to the recall, market withdrawal or similar action action, and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion Jounce under Section 13.1 or Section 13.2Article 7. The costs and expenses incurred after the Vividion Jounce Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Co-Co Product(s) in the US Territory United States shall be borne by the Parties in accordance with their respective portion of the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Jounce Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2Article 7. If Vividion Jounce is invoiced for its portion of such costs and expenses described in this Section 2.4.8 incurred after the Vividion Jounce Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone. Celgene The Lead Party shall, after reasonable consultation with Vividionthe other Party, decide whether to conduct a recall, market withdrawal or similar action in such country or its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 9.3 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Product(s) in the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Co-Co Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in portion of the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephonetelephone or facsimile. Celgene The Lead Party shall, after reasonable consultation with Vividionthe other Party, decide whether to conduct a recall, market withdrawal or similar action in such country or its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) The costs and expenses incurred before the Vividion Jounce Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Co-Co Product(s) in the Territory shall be (I) taken into account in determining either the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product or, in the applicable countryUnited States, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). D. The costs and expenses incurred after the Vividion Jounce Opt-Out Date for any recall, market withdrawal or similar action of any Shared Co-Co Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Jounce Opt-Out Date by the occurrence of the event, incident or circumstance that led to the recall, market withdrawal or similar action action, and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion Jounce under Section 13.1 or Section 13.2Article 7. The costs and expenses incurred after the Vividion Jounce Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Co-Co Product(s) in the US Territory United States shall be borne by the Parties in accordance with their respective portion of the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Jounce Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2Article 7. If Vividion Jounce is invoiced for its portion of such costs and expenses described in this Section 2.4.9 incurred after the Vividion Jounce Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Licensed Product in any portion of the US Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in portion of the US Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) [**] hours advise the other Party thereof by telephonetelephone or facsimile. Celgene shall, after reasonable consultation with Vividion, The JSC shall decide whether to conduct a recall, market withdrawal or similar action in such country or any portion of the US Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other PartyParties, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Agios Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Licensed Product(s) in the US Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory Profit or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, Loss as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D)the Financial Exhibit. The costs and expenses incurred after the Vividion Agios Opt-Out Date for any recall, market withdrawal or similar action of any Shared Licensed Product(s) in the US Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Agios Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion Agios under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Agios Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Licensed Product(s) in the US Territory shall be borne fifty per cent (50%) by each of the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Agios Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion Agios is invoiced for its portion of such costs and expenses incurred after the Vividion Agios Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone. Celgene The Lead Party shall, after reasonable consultation with Vividionthe other Party, decide whether to conduct a recall, market withdrawal or similar action in such country or its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion any Co-Development Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Product(s) Products in the Territory shall be borne by the Parties in accordance with their respective Co-Development Percentages (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.19.2, Section 9.6 9.4 and Exhibit DE). The costs and expenses incurred after the Vividion any Co-Development Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) Products in the Territory shall be borne solely by Celgene BeiGene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion any Co-Development Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion BioAtla under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion any Co-Development Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Product(s) in the US Territory Products shall be borne by the Parties in accordance with the Profit & Loss Share Co-Development Percentages (in effect immediately prior to any Co-Development Opt-Out Date) to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion any Co-Development Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion BioAtla is invoiced for its portion of such costs and expenses incurred after the Vividion any Co-Development Opt-Out Date, payment is due within [***] thirty (30) days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action in connection with a Shared Licensed Product sold in any portion of the TerritoryTerritory during the Term, or in the event either a Betta Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, recall or market withdrawal or similar action in any country in the Territory, the Party notified Betta will advise Agenus thereof by telephone, facsimile or e-mail as promptly as practicable, but at least [*] prior to public disclosure of such recall, market withdrawal or similar actioncorrective action conducted, or the Party that desires except where such recalladvisement would reasonably be expected to result in Betta’s non-compliance with Applicable Law, market withdrawal or similar actionin which case, shall within twentyBetta will advise Agenus thereof as soon as reasonably practicable. Except where it would reasonably be expected to result in Betta’s non-four (24) hours advise the other Party thereof by telephone. Celgene shallcompliance with Applicable Law, after reasonable Betta, in consultation with VividionAgenus, will decide whether to conduct a recall, market withdrawal or similar action in such country or portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall recall will be conducted. Each Party will make available If the Licensed Product that is subject to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar corrective action was caused supplied by Agenus, Agenus will make available all of its pertinent records that may be [*] by Betta in order to effect a recall in the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the Territory. Betta will bear all costs and expenses for that may be incurred in connection with any Licensed Product recall or withdrawal in the Territory; provided, however, that to the extent any such recallrecall or withdrawal is due to the failure of the Licensed Products supplied by Agenus to comply with the specifications of the Licensed Product in accordance with the terms and conditions of the Supply Agreement, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The Agenus will bear all reasonable costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal in connection with such recall or similar action of any Shared Product(s) in the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within [***] days of receipt of invoicewithdrawal.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that If any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action in connection with a Shared the Product in any portion of the Field in the GSK Territory, or in the event either Party if GSK determines that an event, incident or circumstance has occurred that may result in the need for a recall, recall or market withdrawal or similar action in any country of Product in the TerritoryField in the XXX Xxxxxxxxx, the Party notified of such recallXXX will, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party hours, notify Myogen thereof by telephonetelephone or facsimile and use Commercially Reasonable Efforts to discuss such event, incident or circumstance with Myogen in order to jointly determine the appropriate course of action (except in the case of a recall mandated by a Regulatory Authority, in which case GSK may act without such advance notice but, will notify Myogen as soon as possible), and shall provide to Myogen copies of all relevant correspondence, notices and the like. Celgene shallSubject to the foregoing sentence, after reasonable consultation with Vividion, decide GSK will retain ultimate responsibility for deciding whether to conduct a recall, market withdrawal or similar action recall of Product in such country or portion of the Field in the GSK Territory and the manner in which any such recall, market withdrawal or similar action shall recall will be conducted. Each Party Myogen will make available to the other PartyGSK, upon request, all of such Party’s (and its Affiliates’) Myogen's pertinent records that such other Party GSK may reasonably request to assist such other Party GSK in effecting any recall. GSK will bear the expense of any such recall except to the extent such recall was caused in whole or in part by an act or omission of Myogen, market withdrawal or similar actionin which case Myogen will provide such reasonable assistance as is requested by GSK with respect to such recall and bear the expense of any such assistance. (b) The costs and expenses incurred before the Vividion Opt-Out Date relating to If any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action in connection with the Product outside of any Shared Product(s) the Field or in the Territory shall be (I) taken into account in determining the Development Cost Share Myogen Territory, or if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the Myogen determines that an event, incident or circumstance has occurred that led to may result in the recall, need for a recall or market withdrawal of Product outside of the Field or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Product(s) in the US Territory shall be borne Myogen Territory, Myogen will, within twenty-four (24) hours, notify GSK thereof by the Parties in accordance with the Profit & Loss Share telephone or facsimile and use Commercially Reasonable Efforts to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) discuss such event, incident or circumstance ciurcumstance with GSK in order to jointly determine the appropriate course of action (except in the case of a recall mandated by a Regulatory Authority, in which case Myogen may act without such advance notice but, will notify GSK as soon as possible), and shall provide to GSK copies of all relevant correspondence, notices and the like. Subject to the foregoing sentence, Myogen will retain ultimate responsibility for deciding whether to conduct a recall of Product outside of the Field or in the Myogen Territory, and the manner in which any such costs and expenses are not the subject recall will be conducted. GSK will make available to Myogen, upon request, all of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within GSK's pertinent records that Myogen [..***..] days = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. may reasonably request to assist Myogen in effecting any recall. Myogen will bear the expense of receipt any such recall unless such recall was caused in whole or in part by an act or omission of invoiceGSK, in which case GSK will provide such reasonable assistance as is requested by Myogen with respect to such recall and bear the expense of any such assistance.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action in connection with a Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, recall or market withdrawal or similar action in any country in the Territory, the Party notified of such recall, market withdrawal recall or similar action, or the Party that desires such recall, market withdrawal recall or similar action, shall within twenty-four (24) hours hours, advise the other Party thereof by telephonetelephone or facsimile. Celgene shallNycomed, after reasonable in consultation with VividionNPS, shall decide whether to conduct a recall in the Territory (except in the case of a government mandated recall, market withdrawal or similar action in when Nycomed may act without such country or portion of the Territory advance notice but shall notify NPS as soon as possible) and the manner in which any such recall, market withdrawal or similar action recall shall be conducted. Each Party NPS will make available to the other PartyNycomed, upon request, all of such Party’s (and its Affiliates’) NPS’ pertinent records that such other Party Nycomed may reasonably request to assist such other Party Nycomed in effecting any recall, market withdrawal or similar action. Nycomed shall bear the expense of any such recall in the Territory. (b) The costs and expenses incurred before In the Vividion Opt-Out Date relating to event that any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action in connection with Product in any Country of any Shared Product(s) North America, or in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event either Party determines that an event, incident or circumstance has occurred that led may result in the need for a recall or market withdrawal in any Country in North America, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall within twenty-four (24) hours, advise the other Party thereof by telephone or facsimile. NPS, in consultation with Nycomed, shall decide whether to conduct a recall in such Country in North America (except in the case of a government mandated recall, market withdrawal or similar action and (iiwhen NPS may act without such advance notice but, shall notify Nycomed as soon as possible) the event, incident or circumstance and the costs and expenses for manner in which any such recallrecall shall be conducted. Nycomed will make available to NPS, market withdrawal or similar action are not the subject upon request, all of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating Nycomed’s pertinent records that NPS may reasonably request to assist NPS in effecting any recall, market withdrawal or similar action . NPS shall bear the expense of any Shared Product(s) such recall in the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within [***] days of receipt of invoiceNorth America.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal withdrawal, clinical hold involving discontinuation of use of the Product or similar action in connection with a Shared Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours advise the other Party thereof by telephone. Celgene Lannett shall, after reasonable consultation with VividionHEC, decide whether to conduct a recall, market withdrawal or similar action in such country or portion of the Territory US and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The Subject to Article XIII, the costs and expenses incurred before the Vividion Opt-Out Date relating to a recall, market withdrawal withdrawal, clinical hold involving discontinuation of use of the Product or similar action of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, US or (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 9.2 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Product(s) in the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal or similar action in connection with a Shared Licensed Product in any portion of the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or similar action in any country in portion of the Territory, the Party notified of such recall, market withdrawal or similar action, or the Party that desires such recall, market withdrawal or similar action, shall within twenty-four (24) hours [**] advise the other Party thereof by telephonetelephone or facsimile. Celgene The Lead Party shall, after reasonable consultation with Vividionthe other Party, decide whether to conduct a recall, market withdrawal or similar action in such country or its applicable portion of the Territory and the manner in which any such recall, market withdrawal or similar action shall be conducted. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may reasonably request to assist such other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Agios Opt-Out Date relating to a recall, market withdrawal or similar action of any Shared Licensed Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Product in the applicable country, (II) taken into account in determining the Profit & or Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). D. The costs and expenses incurred after the Vividion Agios Opt-Out Date for any recall, market withdrawal or similar action of any Shared Licensed Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Agios Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion Agios under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Agios Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Licensed Product(s) in the US Territory shall be borne by the Parties in accordance with the their respective Profit & or Loss Share Allocation percentages to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Agios Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion Agios is invoiced for its portion of such costs and expenses incurred after the Vividion Agios Opt-Out Date, payment is due within [***] days of receipt of invoice.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action in connection with a Shared Co-Co Licensed Product in any portion of the Co-Co Territory or Genzyme Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, recall or market withdrawal or similar action in any country of a Co-Co Licensed Product in the Co-Co Territory or Genzyme determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of a Co-Co Licensed Product in the Genzyme Territory, the Party notified of such recall, market withdrawal recall or similar action, or the Party that desires such recall, market withdrawal recall or similar action, shall within twenty-four (24) [***] hours advise notify the other Party Party’s CLP Alliance Manager and PJSC representatives thereof by telephonetelephone or e-mail. Celgene shall, after reasonable consultation with Vividion, decide The Parties shall mutually agree whether to conduct a recall, market withdrawal or similar action recall of a Co-Co Licensed Product in such country or portion of the Co-Co Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, market withdrawal or similar action when the Party subject to such mandate may act without such advance notice but shall notify the other Party as soon as possible). Genzyme shall determine whether to conduct a recall of a Co-Co Licensed Product in the Genzyme Territory and the manner in which any such recall shall be conductedconducted (except in the case of a government mandated recall, when Genzyme may act without such advance notice but shall notify Alnylam as soon as possible). Except as may be otherwise agreed by the Parties, each Party shall share equally the expense of any such recall in the Co-Co Territory and Genzyme shall bear the expense of any such recall in the Genzyme Territory. Each Party will make available to the other Party, upon request, all of such Party’s (and its Affiliates’) pertinent records that such other Party may be reasonably request to assist such requested by the other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Optorder to effect a recall of a Co-Out Date relating to a recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared Co Licensed Product in the applicable countryCo-Co Territory or Genzyme Territory. The Parties’ rights and obligations under this Section 4.6 shall be subject to the terms of any supply agreement(s) entered into between the Parties and, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, as, and to the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action event of any Shared Product(s) in conflict between the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal or similar action provisions of any Shared Product(s) in such supply agreement and this Section 4.6, the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion provisions of such costs and expenses incurred after the Vividion Opt-Out Date, payment is due within [***] days of receipt of invoicesupply agreement shall govern.

Recalls, Market Withdrawals or Corrective Actions. (a) In the event that any Regulatory Authority issues or requests a recall, market withdrawal recall or takes a similar action or requires or advises a Party or any of their respective Affiliates, Sublicensees or Third Party Distributors to distribute a “Dear Doctor” letter or its equivalent in connection with a Shared Licensed Product in any portion of the Field in the Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, recall or market withdrawal or similar action of a Licensed Product in any a country in the TerritoryTerritory (each such event, a “Recall”), the Party notified of such recall, market withdrawal Recall or similar action, or the Party that desires determines it may be necessary to initiate such recall, market withdrawal or similar actionRecall, shall within twenty-four (24) hours advise as promptly as possible, notify the other Party thereof by telephonetelephone or e-mail. Celgene shall, after reasonable consultation with Vividion, The Parties shall mutually decide whether to conduct a recall, market withdrawal or similar action Recall of a Licensed Product in such country or portion of the Territory and the manner in which any such recall, market withdrawal or similar action Recall shall be conducted. Each Party If the Parties cannot agree on how to proceed in light of such potential Recall, then the matter will make available be resolved in accordance with Section 2.10(c)(iii). Except as may otherwise be agreed to by the Parties or as set forth in any Commercial Supply Agreement, the Parties shall equally bear the expense of any such Recall in the Territory, provided that to the other extent that a Recall results from a Party’s breach of its obligations hereunder, upon request, all of or from such Party’s (and or its Affiliates’) ’ or Sublicensees’ gross negligence or willful misconduct, such Party shall bear the associated costs of the Recall. Each Party shall make available all of its pertinent records that such other Party may be reasonably request to assist such requested by the other Party in effecting any recall, market withdrawal or similar action. (b) The costs and expenses incurred before the Vividion Opt-Out Date relating order for a Party to affect a recall, market withdrawal or similar action Recall of any Shared Product(s) in the Territory shall be (I) taken into account in determining the Development Cost Share if incurred prior to First Commercial Sale of the applicable Shared a Licensed Product in the Territory. The Parties’ rights and obligations under this Section 4.2 shall be subject to the terms of any applicable countryPharmacovigilance Agreement or Commercial Supply Agreement entered into between the Parties. In the event of a conflict between the provisions of any Pharmacovigilance Agreement or Commercial Supply Agreement, (II) taken into account in determining the Profit & Loss Share if incurred in the US Territory after the First Commercial Sale of the applicable Shared Product in the US Territory or (III) borne solely by Celgene if incurred in a country in the ROW Territory after the First Commercial Sale of the applicable Shared Product in such country (in each case, asas applicable, and to this Section 4.2, the extent, provided in Section 9.1, Section 9.6 and Exhibit D). The costs and expenses incurred after the Vividion Opt-Out Date for any recall, market withdrawal or similar action of any Shared Product(s) in the Territory shall be borne solely by Celgene if and only to the extent (i) such recall, market withdrawal or similar action was caused by the occurrence after the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (ii) the event, incident or circumstance and the costs and expenses for such recall, market withdrawal or similar action are not the subject of an indemnity obligation of Vividion under Section 13.1 or Section 13.2. The costs and expenses incurred after the Vividion Opt-Out Date relating to any recall, market withdrawal or similar action of any Shared Product(s) in the US Territory shall be borne by the Parties in accordance with the Profit & Loss Share to the extent (A) such recall, market withdrawal or similar action was caused by the occurrence before the Vividion Opt-Out Date of the event, incident or circumstance that led to the recall, market withdrawal or similar action and (B) such event, incident or circumstance and such costs and expenses are not the subject of an indemnity obligation of either Party under Section 13.1 or Section 13.2. If Vividion is invoiced for its portion provisions of such costs and expenses incurred after the Vividion Opt-Out DatePharmacovigilance Agreement or Commercial Supply Agreement, payment is due within [***] days of receipt of invoiceas applicable, shall govern.