Product Recalls. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, in the event that a governmental entity issues a request, directive, or order, or [[Party:Organization]] determines, in its sole discretion, to recall or retrieve some or all of the Lead Compound by way of a recall, market withdrawal or other corrective action (“Recall”), [[Party:Organization]] shall, in cooperation with [[Organization A:Organization]], as reasonably requested by [[Organization A:Organization]], conduct such Recall (and any subsequent investigation by [[Party:Organization]] into the cause of the Recall). [[Party:Organization]] shall make every reasonable effort to notify [[Organization A:Organization]] promptly following its determination that any event, incident, or circumstance has occurred that may result in a need for a Recall. [[Party:Organization]] shall have the sole right to determine whether to conduct and control a Recall; provided, that to the extent practicable, [[Party:Organization]] shall consult with [[Organization A:Organization]], through a special meeting of the JDC, prior to any implementation of any such Recall. If a Recall is mandated by a Regulatory Authority, [[Party:Organization]] shall initiate such a Recall in compliance with Applicable Law. […​…].

Product Withdrawals and Recalls. If # any Regulatory Authority threatens, initiates or advises any action to remove any Product from the market in the Territory or requires or advises Unum, SGI, or any of their respective Affiliates to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Territory, or # either Party determines that an event, incident, or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, then in each case ((a) or (b)) Unum or SGI, as applicable, will, to the extent practicable, notify the other Party of such event or determination immediately, and in any event within twenty-four (24) hours (or sooner if required by law) after such Party becomes aware of the event or makes such determination. Each Party will, to the extent practicable, endeavor to discuss and agree with the other Party upon whether to recall or withdraw the Product in the Territory; provided, however, that if such discussion is not practicable or if the Parties fail to agree within an appropriate time period (recognizing the exigencies of the situation), then # Unum will decide whether to recall or withdraw such Product in the Shared Territory; and # SGI will decide whether to recall or withdraw such Product in the Licensed Territory. The Parties will be jointly responsible for conducting any recalls or taking such other necessary remedial action with respect to Products in the Shared Territory, except to the extent that the recall or withdrawal is attributable to the negligence, breach or intentional misconduct of the other Party or any of its Affiliates or subcontractors, in which event the other Party will bear such costs to the extent of its or its Affiliate’s or subcontractor’s responsibility. SGI will be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action with respect to Products in the Licensed Territory, except to the extent that the recall or withdrawal is attributable to the negligence, breach or intentional misconduct of Unum or any of its Affiliates or subcontractors, in which event Unum will bear such costs to the extent of its or its Affiliate’s or subcontractor’s responsibility.

no Product recalls or voluntary Product Market Withdrawals from any market (other than those recalls or Market Withdrawals disclosed on [Schedule 4.23(d)]).

Schedule #(a): Financing Statements and Other Filings [Schedule 4.23(d)]: Product Recalls And Market Withdrawals [Schedule 7.2(d)]: Existing Indebtedness

If we experience product recalls, we may incur significant and unexpected costs and our business reputation could be adversely affected.

We may be exposed to product recalls and adverse public relations if our products are alleged to cause illness or injury, or if we are alleged to have violated governmental regulations. A product recall could result in substantial and unexpected expenditures that could

Except as set forth in [Schedule 2.20(c)] of the Company Schedules, there have been no recalls, market withdrawals or replacements (voluntary or involuntary) with respect to any Company Product or any similar actions, investigations, notices or threatened recalls by any Governmental Entity with respect to any Company Product and, to the knowledge of the Company, no facts or circumstances exist that are reasonably likely to # result in the recall, market withdrawal or replacement of any Company Product sold or intended to be sold, or # cause, as a result of any regulatory action by any Governmental Entity, # a material change in the labeling or packaging of any Company Product or # a termination or suspension of the marketing, distribution or sale of any Company Product.

All products are subject to customer service claims, malfunctions and defects, which may subject us to requests for product exchanges, returns, warranty claims and recalls. If we are unable to maintain a certain degree of quality control of our products we will incur costs of replacing and or recalling our products and servicing our customers. Any product returns, exchanges, and or recalls we may make will have a material adverse effect on our business, our operations and our profitability and will likely result in the loss of customers and goodwill.

any and all normal and customary trade, prompt payment, cash and quantity discounts, customary allowances actually granted to purchasers of a Product for returns and recalled Product (including in connection with Product withdrawals, expired Product and Product recalls), chargeback and reporting fees paid to wholesalers and other distributors, allowances to end users participating in incentive programs, rebates and other credit adjustments based upon shipping discrepancies and order errors;

Neither the Company, any Subsidiary, nor, to the Company’s knowledge, any of its or their licensees, partners, collaborators or joint venturers has developed, manufactured, commercialized, produced, formulated, propagated, modified, customized, processed, distributed or sold any Company Product that did not comply with any express or implied warranty regarding such Company Product or that contained any unintended Hazardous Substance or that was otherwise adulterated, contaminated, mislabeled, defective, off-specification or improperly packaged or transported.