Common use of Product Recalls Clause in Contracts

Product Recalls. (a) In the event: (i) any Regulatory Authority or other national government authority issues a request, directive or order that the Product be recalled; (ii) a court of competent jurisdiction orders such a recall, or (iii) Theravance or Hospira reasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. (b) In the event that such recall results from a breach of Hospira’s express warranties under Sections 8.2(a) and 8.2(b), Hospira shall be responsible for replacing the quantity of Products that were recalled at no cost to Theravance. Hospira shall use all commercially reasonable efforts to replace such Product as soon as practicable. In addition, Hospira agrees that it shall be responsible for the administrative expenses of any recall. For purposes of this Agreement, the administrative expenses of recall shall include the expenses of notification and destruction or return of the recalled Product, and any costs associated with the delivery of replacement Product, but shall not include lost profits of either party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d). In the event that the recall does not result from the breach of Hospira’s express warranties under this Agreement, Theravance shall be responsible for the expenses of the recall.

Product Recalls. In the event (a) In the event: (i) any Regulatory Authority or other national government authority issues a request, directive or order that the Product be recalled; , (iib) a court of competent jurisdiction orders such a recall, or (iiic) Theravance Company or Hospira reasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding relating to the recall. (b) . In the event that such recall results from a the breach of Hospira’s express warranties under Sections Section 8.2(a) and 8.2(b), Hospira shall be responsible for replacing the quantity of Products that were recalled at no cost to Theravance. Hospira shall use all commercially reasonable efforts to replace such Product as soon as practicable. In addition, Hospira agrees that it shall be responsible for the administrative expenses of any recall. For purposes or (b) of this Agreement, the administrative expenses of recall Hospira shall include the expenses of notification and destruction or return of the recalled Product, and any costs associated with the delivery of replacement Product, but shall not include lost profits of either party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d)only be responsible for (i) [ * ] (ii) [ * ]. In the event that the recall does not result from the breach of Hospira’s express warranties under this Agreement, Theravance Company shall be responsible for the expenses of the recall. For purposes of this Agreement, the expenses of the recall shall include, but not be limited to, the expenses of notification and destruction or return of the recalled Product, cost of the recalled Product, and any costs associated with the distribution of the replacement Product, but shall not include lost profits of either party. [ * ] = 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.

Product Recalls. (a) In the event: (i) any Regulatory Authority or other national government authority issues a request, directive or order that the Product be recalled; (ii) a court of competent jurisdiction orders such a recall, ; or (iii) Theravance Kythera or Hospira reasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. (b) In the event that such recall results from a the breach of Hospira’s express warranties under Sections Section 8.2(a) and 8.2(bor (b), Hospira agrees that it shall be responsible for promptly replacing the quantity of Products Product that were was recalled at no cost to Theravance. Hospira shall use all commercially reasonable efforts to replace such Kythera or reimbursing Kythera for the cost of the Product as soon as practicablethat was recalled. In addition, Hospira agrees that it shall be responsible for the administrative expenses of any recall. , provided, however, that Hospira shall not pay more than [*] United States Dollars ($US [*]) per recall, For purposes of this Agreement, the administrative expenses of the recall shall include include, but not be limited to, the expenses of notification and destruction or return of the recalled Product, and any costs associated with the delivery distribution of the replacement Product, but shall not include lost profits of either party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d). In the event that the recall does not result from the breach of Hospira’s express warranties under this Agreement, Theravance Kythera shall be responsible for the expenses of the recall.

Product Recalls. (a) In the event: event (i) any Regulatory Authority or other national government authority issues a request, directive or order that the Product be recalled; (ii) a court of competent jurisdiction orders such a recall, or (iii) Theravance or Hospira Revance reasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. (b) In the event that such recall results from a the breach of Hospira’s express warranties under Sections 8.2(aSection 7.2(a) and 8.2(bor (b), or other obligations hereunder, Hospira agrees that it shall be responsible for promptly replacing the quantity of Products that were recalled at no cost to Theravance. Hospira shall use all commercially reasonable efforts to replace such Product as soon as practicableRevance (without the Components that were the subject of the recall) or reimbursing Revance for the cost of the Products that were recalled. In addition, Hospira agrees that it shall be responsible for the administrative expenses of any recall, provided that Hospira shall not pay more than [***]. For purposes of this Agreement, the administrative expenses of the recall shall include include, but not be limited to, the expenses of notification and destruction or return of the recalled Product, and any costs associated with the delivery distribution of the replacement Product, but shall not include lost profits of either party, nor . To the cost to replace API in excess of the limitations stated in Section 5.4(d). In the event extent that the recall does not result from the breach of Hospira’s express warranties under [ ] = Certain confidential information contained in this Agreementdocument, Theravance shall be responsible for marked by brackets, has been omitted and filed separately with the expenses Securities and Exchange Commission pursuant to Rule 406 of the recallSecurities Act of 1933, as amended.

Product Recalls. (a) In the event: (ia) any Regulatory Authority or other national government authority issues a request, directive or order that the Product Products be recalled; (iib) a court of competent jurisdiction orders such a recall, recall or withdrawal; or (iiic) Theravance MediciNova or Hospira reasonably determines that Product the Products should be recalledrecalled or withdrawn, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. (b) . In the event that such recall results from a the breach of Hospira’s express warranties under Sections 8.2(a) and 8.2(b)this Agreement or its negligence or willful misconduct, Hospira shall be responsible for promptly replacing the quantity of Products that were recalled at no cost to Theravance. Hospira shall use all commercially reasonable efforts to replace such Product as soon as practicableMediciNova or reimbursing MediciNova for the total cost of the Products that were recalled. In addition, Hospira agrees that it shall be responsible for [***]. To the administrative expenses of any recall. For purposes of this Agreement, the administrative expenses of recall shall include the expenses of notification and destruction or return of the recalled Product, and any costs associated with the delivery of replacement Product, but shall not include lost profits of either party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d). In the event extent that the recall does not result from the breach of Hospira’s express warranties under this Agreement, Theravance or its negligence or willful misconduct, MediciNova shall be responsible for the expenses of the recallrecall and Hospira will have no obligation to replace recalled Products. Certain information in this exhibit, marked by brackets and asterisks [***], has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.

Product Recalls. (a) In the event: event (i) any Regulatory Authority or other national government authority issues a request, directive or order that the Finished Product be recalled; (ii) a court of competent jurisdiction orders such a recall, or (iii) Theravance Orchid or Hospira reasonably determines that Finished Product should be recalled, the parties Parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recallrecall in accordance with the procedures set forth in the Technical/Quality Agreement. (b) In the event that such recall results from a the breach of Hospira’s express warranties under Sections 8.2(a) and 8.2(b)Section 2.8, Hospira agrees that it shall be responsible for replacing promptly reimbursing Orchid for the quantity cost of the Finished Products that were recalled at no cost recalled, subject to Theravance. Hospira shall use all commercially reasonable efforts to replace such Product as soon as practicablethe limitation contained in Section 7.5. In addition, Hospira agrees that it shall be responsible for the administrative expenses of any recall, subject to the limitation contained in Section 7.5. For [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC. purposes of this Agreement, the administrative expenses of the recall shall include include, but not be limited to, the expenses of notification and destruction or return of the recalled Finished Product, and any costs associated with the delivery distribution of the replacement Finished Product, but shall not include lost profits of either party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d). party In the event that the recall does not result from the breach of Hospira’s express warranties under this Agreement, Theravance Orchid shall be responsible for the expenses of the recall.

Product Recalls. (a) In the event: (ia) any Regulatory Authority or other national government authority issues a request, directive or order that the Product be recalled; (iib) a court of competent jurisdiction orders such a recall, ; or (iiic) Theravance Theratechnologies or Hospira reasonably determines that the Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. (b) . In the event that such recall results from a breach [Redacted: Description of Hospira’s express warranties under Sections 8.2(a) and 8.2(b)Obligation] of this Agreement, Hospira shall be responsible for promptly replacing the quantity of Products that were recalled at no cost to Theravance. Hospira shall use all commercially reasonable efforts to replace such Product as soon as practicableTheratechnologies or reimbursing Theratechnologies for the cost of the Products that were recalled. In addition, Hospira agrees that it shall be responsible for the all administrative expenses of any the recall. For purposes of this Agreement, the administrative expenses of recall shall include the expenses of notification and destruction or return of the recalled Product, and any costs associated with the delivery of replacement Product, but shall not include lost profits of either party, nor the cost to replace API in excess of the limitations stated in Section 5.4(d). Theratechnologies — Hospira Diluent Agreement In the event that the recall does not result from the breach [Redacted: Description of Hospira’s express warranties under Obligation] this Agreement, Theravance Theratechnologies shall be responsible for the expenses of the recall. For purposes of this Agreement, [Description of Expenses].