Recalls. If any of the Licensed Products pose a safety threat to the consumer, Licensee shall immediately recall such Licensed Products from the marketplace, and take any other measures Licensor may reasonably demand. If any of the Licensed Products are the subject of negative publicity due to poor quality and/or safety of the Licensed Products, Licensee shall, upon Licensor’s reasonable request, immediately recall such Licensed Products from the marketplace, and take any other measures Licensor may reasonably demand. Notwithstanding, Licensor shall be entitled to Royalties for all sales of Licensed Products that may be recalled for any reason. Licensee shall assume all the obligations, liabilities, costs and expenses relating in any recalls of Licensed Product under this Section 7.4.

Recalls. If: # any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled; # a court of competent jurisdiction orders a Recall; or # Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to all Applicable Laws.

Recalls. In the event that a Product or Drug Substance is recalled or withdrawn, Apellis shall be responsible for such recall or withdrawal. [[Bachem CH:Organization]] shall fully cooperate with Apellis in connection with such recall or withdrawal. Apellis shall bear the cost of such recall or withdrawal and Apellis shall reimburse [[Bachem CH:Organization]] for reasonable out of pocket expenses incurred by [[Bachem CH:Organization]] in connection with such recall or withdrawal; provided, that in the event a Product or Drug Substance is recalled or withdrawn as the result of a Manufacturing issue as to which [[Bachem CH:Organization]] is obligated to provide indemnification hereunder, [[Bachem CH:Organization]] shall reimburse Apellis for # all reasonable costs associated with the recalled or withdrawn Product or Drug Substance, including the Supply Price for Product and # all reasonable and documented expenses incurred in connection with such recall or withdrawal, in each case subject to the limitation of liability provisions set forth in Sections 12.4 and 12.5 of this Agreement.

Recalls. If a recall, withdrawal, or correction (including the dissemination of relevant information) of any Product in a Party’s Territory is required by a Regulatory Authority of competent jurisdiction, or if a recall, withdraw, or correction of a Product in its respective Territory is deemed advisable by such Party in its sole discretion, then such Party shall so notify the other Party no later than ​ in advance of the earlier of # initiation of a recall, withdrawal, or correction, or # the submission of plans for such an action to a Regulatory Authority. Any such recall, withdrawal, or correction shall be referred to herein as a “Recall”. Promptly after being notified of a Recall, each Party shall provide the other Party with such assistance in connection with such Recall as may be reasonably requested by such other Party. All costs and expenses in connection with a Recall in a Party’s Territory, including the costs and expenses related to the dissemination of relevant information, shall be borne by such Party unless such Party proves that such Recall is required due to # the other Party’s breach of the representations, warranties, covenants or obligations under this Agreement and/or violation of Applicable Laws or # the intentional misconduct or negligent acts by the other Party; provided that, with respect to a Recall of Licensed Antibody or Product that is supplied by or on behalf of [[Forty Seven:Organization]] pursuant to a supply agreement entered into between the Parties pursuant to [Section 7.2 or 7.3.3], the provisions of such supply agreement shall solely apply. Each Party shall handle exclusively the organization and implementation of all Recalls of Products in its respective Territory.

Recalls. If: # any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled; # a court of competent jurisdiction orders a Recall; or # Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to all Applicable Laws.

Recalls. If # any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, # a court of competent jurisdiction orders a Recall, or # Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating to restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.

Recalls. If any Regulatory Authority issues or requests a recall or market withdrawal of the Licensed Product, or if either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of the Licensed Product in such Party’s territory, the Party notified of such recall or withdrawal, or the Party that desires such recall or withdrawal, will advise the other Party thereof by telephone or facsimile within twenty-four (24) hours of # its receipt of notice from a Regulatory Authority requiring or requesting a recall or withdrawal or # such Party’s determination that it may need to institute a recall or withdrawal, and the JCC shall convene a joint telephonic meeting to discuss such recall or withdrawal request within twenty-four (24) hours of such notification. Notwithstanding Section 3.5, Licensee shall be responsible for making decisions regarding recalls or withdrawals of the Licensed Product in the Field in the Territory, and Acorda shall be Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets ​ and an asterisk*, have been separately filed with the Securities and Exchange Commission.

Recalls. If # any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, # a court of competent jurisdiction orders a Recall, or # Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, [[Organization A:Organization]] will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.

Recalls. In the event that either Party should become aware of information that may require a recall of any Product, such Party shall notify the other Party in writing within twenty-four (24) hours of becoming aware of such information. SAVARA shall control the conduct of any recall (including any determination as to whether a recall is required) and shall implement and coordinate all activities reasonably necessary in connection with such recall, including making all contact with relevant Regulatory Authorities; provided however that, before initiating a recall, SAVARA shall first notify GEMA and, to the extent practicable, consult in good faith with GEMA. GEMA shall cooperate with SAVARA and provide assistance to SAVARA, as reasonably requested, in conducting such recall, including providing all pertinent records that SAVARA may reasonably request to assist in effecting such action. In the event of a recall due to any failure of a Product due to the API’s failure to meet the applicable API Specifications or warranties set forth in [Section 11.2], it is agreed and understood that any expenses (including reasonable fees of any experts or attorneys that may be utilized by either Party, government fines or penalties related to such recall) (“Recall Costs”) shall be borne by GEMA. Otherwise the Recall Costs shall be borne by SAVARA.

Recalls. Without prejudice to Licensee’s right to indemnity pursuant to this Agreement or the Supply Agreement, to the extent that: # any Regulatory Authority in the Licensee Territory issues a directive or order that any Product be recalled or withdrawn in any country within the Licensee Territory; # a court of competent jurisdiction orders a recall or withdrawal of any Product in any country within the Licensee Territory, or # Licensee determines the Product should be recalled or withdrawn voluntarily in any country within the Licensee Territory, Licensee will recall or withdraw the Product. Either Party shall advise the other Party of any Regulatory Authority-initiated mandatory recall of the Product in its respective territory. Neither Party shall initiate any voluntary recall of the Product in its respective territory without the prior written notice to the other Party.