Common use of Remedial Actions Clause in Contracts

Remedial Actions. Each Party will notify the other Parties immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the manufacture, distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and shall be responsible for all cost and expense of such Remedial Action in its territory.

Remedial Actions. Each Party will, and will ensure that its Affiliates and Sublicensees will, notify the other Parties Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed a Product may be subject to any recall, corrective action or other regulatory action with respect to such product a Product taken by virtue of Applicable applicable Law in the Territory (a “Remedial Action”). The Parties (or Daewoong’s Sublicensees and Ampio), as the case may be, will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party Daewoong shall, and shall ensure that its Affiliates and sublicensees Sublicensees will, maintain or have maintained adequate records to permit the Parties to trace the manufacturemanufacture of the Product and the distribution and, distribution and use (to the extent possible) feasible, the use of the Licensed ProductsProduct. As In the event Daewoong or its any Sublicensee determines that any Remedial Action with respect to a Product in the Field in the Territory should be commenced or Remedial Action is required by any Regulatory Authority having jurisdiction over the matter, Daewoong will, and will ensure that its Sublicensees will, as the case may be, control and coordinate all efforts necessary to conduct such Remedial Action. In the event Ampio determines that any Remedial Action with respect to a Product outside the Field in the Territory should be commenced or Remedial Action is required by any Regulatory Authority having jurisdiction over the matter, Ampio will control and coordinate all efforts necessary to conduct such Remedial Action. For clarity, as between the Parties, ZAI Ampio shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO Retained Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and shall be responsible for all The cost and expense of such a Remedial Action arising from the development, manufacture or commercialization of the Product in the Field in the Territory shall be borne solely by Daewoong or its territorySublicensees.

Remedial Actions. Each Party will party shall notify the other Parties immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed of the Product may would reasonably be expected to be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law (a “Remedial Action”). The Parties will parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a or appropriate responses to Remedial Action. Purchaser shall solely make the final determination whether and how to commence any Remedial Action with respect to the Product. Each Party shall, and party shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties Purchaser to trace the manufacture, manufacture of the Product and the distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO TerritoryProduct. In the event that a Party Purchaser determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, commenced or if Remedial Action is required by any Regulatory Authority governmental authority having jurisdiction over the matter in its Territorymatter, such Party will Purchaser shall have exclusive control of, and coordinate shall coordinate, all efforts necessary to conduct such Remedial Action; provided, however, that if Purchaser seeks indemnity for Seller for such Remedial Action, Seller shall be allowed to control the Remedial Action. If Purchaser conducts any Remedial Action related to the Product and shall Seller is ultimately determined to be responsible for the problem requiring the Remedial Action including faulty manufacture, failure to comply with Regulatory Standards, or failure to produce Product that meets Specifications, then Seller, at Purchaser’ option, shall reimburse Purchaser for its cost of all cost and expense of Purchaser devices subject to such Remedial Action in its territoryAction.

Remedial Actions. Each Party will shall notify the other Parties immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law any Governmental Authority (a “Remedial Action”). The Parties will shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Licensee shall have sole discretion, except as required by applicable Law, with respect to any matters relating to any Remedial Action in or for the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action, and Licensor shall, and shall cause its Affiliates to, cooperate fully with Licensee’s reasonable requests in respect of such matters. Unless otherwise provided in any applicable supply agreement between the Parties or their Affiliates, and subject to Section 8.2, the costs and expenses of any Remedial Action in or for the Territory shall be borne solely by Licensee, and the costs and expenses of any Remedial Action outside the Territory shall be borne solely by Licensor. Each Party shallshall maintain, and shall ensure that its Affiliates and sublicensees willshall maintain, maintain adequate records to permit the Parties to trace the manufacture, distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and shall be responsible for all cost and expense of such Remedial Action in its territorytheir respective territories.

Remedial Actions. Each Party will notify the other Parties Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed the Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law (a “Remedial Action”)applicable Laws. The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Actionany remedial action. Each Party POINT shall, and shall ensure that its Affiliates and sublicensees Sublicensees will, maintain adequate records to permit the Parties to trace the manufacture, distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO TerritoryProduct. In the event that a Party POINT determines that any Remedial Action remedial action with respect to the Licensed Product in its the Field in the Territory should be commenced, commenced or if Remedial Action is required by any the applicable Regulatory Authority having jurisdiction over Authority, POINT shall have the matter in its Territory, such Party will right to control and coordinate all efforts necessary to conduct such Remedial Action remedial action; provided that, with respect to any such remedial action that is not imposed upon POINT by applicable Law or a Regulatory Authority, such remedial action shall have been reviewed and shall be responsible approved by the JCC. If the JCC fails to unanimously approve a remedial action that is not imposed upon POINT by applicable Law or Regulatory Authority within [***] days after such remedial action is presented to the JCC for all cost review and expense of approval, then the Parties’ Executive Officers (one Executive Officer from each Party) shall, within [***] thereafter, review and approve by majority such Remedial Action remedial action or, in its territorythe event that the Executive Officers fail to approve such remedial action within such time period, POINT has the right to control and coordinate the efforts necessary to conduct such remedial action as provided above.

Remedial Actions. Each Party will shall notify the other Parties immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product the Product taken by virtue of Applicable Law (a “Remedial Action”). The Parties will shall fully assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates Affiliates, (sub)licensees, (sub)contractors and sublicensees willDistributors shall, maintain adequate records to permit the Parties to trace the manufactureManufacture, distribution and use (to the extent possible) of the Licensed Products, as required by Applicable Law. As between the Parties, ZAI Each Party shall have sole discretion with respect to any matters relating to any Remedial Action for in its territory (i.e., the Licensed Product in Territory for Sanofi and the ZAI Retained Territory and TESARO shall have sole discretion with respect for MyoKardia), including the decision to any matters relating to any Remedial Action for the Licensed Product in the TESARO Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territory, such Party will control and coordinate all efforts necessary to conduct commence such Remedial Action and shall be responsible for all the control over such Remedial Action, at its sole cost and expense (except to the extent treated as Allowable Expenses); provided that to the extent such Remedial Action results from (a) the breach of the other Party’s obligations hereunder or (b) the negligence, recklessness or willful misconduct of such other Party, in each case, such other Party shall bear the costs and expenses of such Remedial Action (and such costs and expenses will not be included in its territoryAllowable Expenses).

Remedial Actions. Each Party will shall notify the other Parties immediatelyimmediately in writing, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law any governmental authority or Regulatory Authority (a “Remedial Action”). The Parties will shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Territory. Licensee shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action. Zenas shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study; provided that Zenas shall consult with the JSC regarding such matters and reasonably consider the comments of Licensee’s JSC members. Except as otherwise provided under the Clinical Supply Agreement or the Commercial Supply Agreement, the cost and expenses of any Remedial Action in the Territory shall be borne solely by the Party with sole discretion to control such Remedial Action. Each Party shall, and shall ensure that its Affiliates and sublicensees willshall, maintain adequate records to permit the Parties to trace the manufacture, distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and shall be responsible for all cost and expense of such Remedial Action in its their respective territory.

Remedial Actions. Each Party will notify the other Parties Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law applicable Laws (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party SAMR shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the manufacturedistribution, distribution sale and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product Products in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO Applicable Territory. In the event that a Party If SAMR or any of its Affiliates determines that any Remedial Action with respect to the any Licensed Product in its an Applicable Territory should be commenced, commenced or if Remedial Action is required by any applicable Laws or Regulatory Authority having jurisdiction over the matter in its TerritoryAuthority, such Party will control and coordinate all efforts necessary to conduct then such Remedial Action and shall be responsible for all cost and at the expense of SAMR. Remedial Actions that are not required by Law, but are deemed necessary by Aridis in the exercise of reasonable discretion, may be required by Aridis, the expenses of which shall be borne by Aridis unless agreed by the JSC. Otherwise, each Party shall provide the other Party, at the other Party’s expense, with such assistance in connection with a Remedial Action in its territoryas may be reasonably requested by such other Party. Notwithstanding the foregoing, any Remedial Action that relates to the manufacture and supply of Licensed Products by one Party to another shall be governed by the terms and conditions of the relevant Supply Agreement.

Remedial Actions. Each Party will shall notify the other Parties immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law any Regulatory Authority (a “Remedial Action”). The Parties will shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Licensee shall have sole discretion, except as required by applicable law, with respect to any matters relating to any Remedial Action in or for the Territory, including the decision to commence such ​ ​ Remedial Action and the control over such Remedial Action, and Licensor shall, and shall cause its Affiliates to, cooperate fully with Licensee’s reasonable requests in respect of such matters. Unless otherwise provided in any applicable supply agreement between the Parties or their Affiliates, the costs and expenses of any Remedial Action in or for the Territory shall be borne solely by Licensee, and the costs and expenses of any Remedial Action outside the Territory shall be borne solely by Licensor. Each Party shallshall maintain, and shall ensure that its Affiliates and sublicensees willshall maintain, maintain adequate records to permit the Parties to trace the manufacture, distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and shall be responsible for all cost and expense of such Remedial Action in its territorytheir respective territories.

Remedial Actions. Each Party will notify the other Parties Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any a Licensed Product may be subject to any recall, corrective action or other regulatory action with respect to such product a Licensed Product taken by virtue of Applicable Law applicable Laws (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the manufactureManufacture, distribution and use (to the extent possible) of the a Licensed Products. As between the Parties, ZAI shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the ZAI Territory and TESARO shall have sole discretion with respect to any matters relating to any Remedial Action for the Licensed Product in the TESARO TerritoryProduct. In the event that a Party GSK determines that any Remedial Action with respect to the a Licensed Product in its the Licensed Territory should be commenced, commenced or if Remedial Action is required by any applicable Regulatory Authority having jurisdiction over Authority, GSK shall have the matter in right, at its Territoryexpense, such Party will to control and coordinate all efforts necessary to conduct such Remedial Action. In the event Impax determines that any Remedial Action with respect to a Licensed Product outside the Licensed Territory should be commenced or is required by applicable Regulatory Authority, Impax shall have the right, at its expense, to control and coordinate all efforts necessary to conduct such Remedial Action. Notwithstanding the foregoing, any Remedial Action that relates to the Manufacture and supply of a Licensed Product by Impax to GSK shall be responsible for all cost governed by the terms and expense conditions of such Remedial Action in its territorythe Supply Agreement.

Remedial Actions. Each Party will notify the other Parties Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, withdrawal, corrective action or other regulatory action with respect to such product taken by virtue of Applicable Law (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates and sublicensees Sublicensees will, maintain adequate records to permit the Parties to trace the manufactureManufacture, distribution and use (to the extent possible) of the Licensed Products. As between the Parties, ZAI Licensee shall have sole discretion with respect to any matters relating to any Remedial Action for inside of the Licensed Product in the ZAI Territory Territory, and TESARO Licensor shall have sole discretion with respect to any matters relating to any Remedial Action for outside of the Licensed Product in the TESARO Territory. In the event that a Party determines that any Remedial Action with respect to the Licensed Product in its Territory territory should be commenced, or if Remedial Action is required by any Regulatory Authority having jurisdiction over the matter in its Territoryterritory, such Party will control and coordinate all efforts necessary to conduct such Remedial Action and shall be responsible for all cost and expense of such Remedial Action in its territory.