Common use of Product Recalls Clause in Contracts

Product Recalls. Each party promptly shall notify the other if any Batch of the Product is alleged or proven to be the subject of a recall, market withdrawal or correction. Nephron shall be responsible for coordinating any recall, market withdrawal or field correction of the Product, and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating to such recall, market withdrawal or field correction. RevitaLid shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) in connection with such recall, market withdrawal or field correction, at Nephron’s expense. Unless such recall is caused solely by the negligence, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron shall be responsible for all of the costs and expenses of such recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Drug Substance and notification of the recall to those persons whom Nephron deems appropriate). THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Product Recalls. Each party promptly shall notify In the other if event (a) any Batch of government authority issues a request, directive or order that the Product is alleged be recalled, or proven to be the subject (b) a court of competent jurisdiction orders such a recall, market withdrawal or correction. Nephron shall (c) Allergan and Ista, after consultation with each other, determine that the Product should be responsible for coordinating any recallrecalled, market withdrawal or field correction of the Product(d) either Allergan or Ista, and recallafter consultation with each other, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating if legally required to make such recall, market withdrawal or field correction. RevitaLid does so, the parties shall take all appropriate corrective actions, and shall cooperate in the investigations surrounding the recall. Allergan shall handle notification of customers and return of Product from customers. The owner of the relevant regulatory approval shall handle all communications and requests with Nephron (including providing Nephron with all data, information and documents requested by Nephron) in connection with such recall, market withdrawal or field correction, at Nephron’s expenseregulatory agencies regarding any recalls. Unless If such recall results from any cause or event arising from a sole responsibility of Ista as set forth in this Agreement or in the Supply Agreement or is caused solely by the negligenceattributable to Ista, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron Ista shall be responsible for all expenses of the costs recall and Allergan may deduct any such expenses borne by Allergan from any payment due to Ista under this Agreement. If such recall results from a sole responsibility of Allergan as set forth in this Agreement or in the Supply Agreement or is solely attributable to Allergan, Allergan shall be responsible for the expenses of recall and shall reimburse Ista for expenses incurred by Ista for such recall, market withdrawal or field correction. In the event that the recall results from any cause(s) or event(s) arising from a recalljoint responsibility of the parties or partially from a responsibility of Ista and partially from a responsibility of Allergan, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving Ista and administering the recalled Drug Substance and notification Allergan shall be jointly responsible for expenses of the recall in proportion to those persons whom Nephron deems appropriate)each such party's proximate fault with respect to the recall. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUESTIf the parties are unable to agree on the allocation of such fault, then such dispute shall be subject to the dispute resolution provisions of Section 15. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONFor the purpose of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Product, cost for the Product recalled, legal expenses, inventory write-offs and penalties resulting from Third Party contracts, but shall not include goodwill, lost profits or other similar intangible or speculative claims.

Product Recalls. Each In the event (a) any government authority issues a directive or order that a Product manufactured or supplied by Applied hereunder be recalled; or (b) a court of competent jurisdiction orders such a recall; or (c) Customer, or (d) Applied, reasonably determines that any such Product should be recalled, the parties shall take all appropriate corrective actions to best preserve the Product’s good will and reputation. If a recall is due to (a) or (b), the party promptly primarily responsible for the cause of the recall shall notify assume responsibility for all such costs and expenses and shall reimburse the other if party for any Batch costs and expenses incurred by such party. If a recall is due to (c) or (d), the party calling for the recall shall initially bear the expenses of the Product recall until primary responsibility for the cause of the recall is alleged or proven to be determined, at which time the subject of a recall, market withdrawal or correction. Nephron shall be party primarily responsible for coordinating any recall, market withdrawal or field correction the cause of the Product, recall shall assume responsibility for all such costs and recall, market withdrawal or correction expenses and shall be conducted in accordance reimburse the other party for all costs and expenses incurred by such party. If recalled due to nonconformance with the provisions of FDA’s current Good Manufacturing Practices, failure to meet the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating to such recallSpecifications, market withdrawal or field correction. RevitaLid shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) in connection with such recall, market withdrawal or field correction, at Nephron’s expense. Unless if such recall is caused solely by otherwise due to the negligenceactions or negligence of Applied, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron Applied shall be considered the party primarily responsible in which case Applied shall be responsible for all expenses of recall and shall hold Customer, its employees and representatives harmless. Otherwise, Customer shall be responsible for all expenses of recall and shall hold Applied, its employees and representatives harmless for this action. For the purpose of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification of Customers, the expenses of return and/or destruction of the costs recalled product, any necessary product rework expense, any legal expenses incurred and other reasonable expenses of such recall, market withdrawal or field correction. In the event incurred as a recall, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Drug Substance and notification result of the recall to those persons whom Nephron deems appropriate). THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONabove mentioned action.

Product Recalls. Each party promptly shall notify the other if If any Batch of the Product is CyDex-supplied Captisol should be alleged or proven not to be meet the subject Specifications, Sage shall notify CyDex immediately, and both parties shall cooperate fully regarding the investigation and disposition of any such matter. In the event that a recalldispute arises between the parties as to whether or not CyDex-supplied Captisol purchased by Sage meets the Specifications, market withdrawal or correction. Nephron such dispute shall be responsible for coordinating any recall, market withdrawal or field correction immediately resolved by submitting it to an independent quality control laboratory mutually agreed upon by the parties. The findings of such independent laboratory shall be binding upon the parties. The cost of the independent quality control laboratory shall be borne by the party whose results are shown by such laboratory to have been incorrect. If (i) Sage and CyDex agree in writing that it is appropriate to recall any Licensed Product, or (ii) the FDA or other relevant governmental authority requires the recall of any Licensed Product, and in either case, to the extent that such recall is due to issues relating to CyDex-supplied Captisol, then CyDex agrees, upon substantiation thereof, to bear a proportionate share (based on the extent to which the recall was caused by issues relating to CyDex-supplied Captisol) of the reasonable direct costs associated with said recall, market withdrawal or correction shall be conducted including a proportionate share of the actual cost of conducting the recall in accordance with the provisions recall guidelines of the Quality Agreementapplicable governmental authority, including without limitation, a proportionate share of the cost of the Licensed Product subject to the recall. Nephron Sage shall provide RevitaLid in all events be responsible for conducting any such recalls with respect to the Licensed Products, including the sole right to determine whether to conduct any such recall (although it is understood that a copy of all documents relating unilateral decision by Sage, not required by the FDA or other relevant governmental authority, to conduct a recall would negate CyDex’s agreement under the preceding sentence with respect to such recall), market withdrawal or field correction. RevitaLid and shall cooperate with Nephron (including providing Nephron with maintain records of all data, information sales of Licensed Products and documents requested by Nephron) in connection with customers sufficient to adequately administer any such recall, market withdrawal or field correction, at Nephron’s expense. Unless such recall is caused solely by the negligence, omission or willful misconduct for a period of RevitaLid or solely by RevitaLid’s breach five years after termination of its warranties or obligations under this Agreement, Nephron shall be responsible for all of the costs and expenses of such recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Drug Substance and notification of the recall to those persons whom Nephron deems appropriate). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAS BEEN REDACTED WERE OMITTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED REPLACED WITH “[***] AND ]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSIONCOMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Product Recalls. Each party promptly In the event Sepracor or Breath shall notify be required or requested by any governmental authority (or shall voluntarily decide) to recall any Products, because such Products may violate any laws or regulations or for any other reason, the other if Parties shall cooperate fully with one another in connection with any Batch recall. If a recall is due to Sepracor's gross negligence, willful misconduct or material breach of this Supply Agreement, Sepracor shall reimburse Breath for the Transfer Price and any Additional Payment paid by Breath for such recalled Products, all of the Product reasonable costs and expenses actually incurred by Breath in connection with the recall including, but not limited to, costs of retrieving Products already delivered to customers, costs and expenses Breath is alleged required to pay for notification, shipping and handling charges, and such other costs as may be reasonably related to the recall. If a recall is due to Breath's gross negligence, willful misconduct or proven material breach of this Supply Agreement, Breath shall remain responsible for the Transfer Price and any Additional Payments for such recalled Products and Breath shall reimburse Sepracor for all the reasonable costs and expenses described above actually incurred by Sepracor in connection with such recall including administration of the recall and such other actual costs as may be reasonably related to be the subject recall. If a recall results from a cause other than the negligence, willful misconduct or material breach of a recallthis Supply Agreement of or by Sepracor or Breath, market withdrawal or correction. Nephron Breath shall remain responsible for the Transfer Price of the recalled Product, but not for any Additional Payments associated with the recalled Products, and each Party shall be responsible for coordinating any recall, market withdrawal or field correction of the Product, its own reasonable costs and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating to such recall, market withdrawal or field correction. RevitaLid shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) expenses incurred in connection with such recall, market withdrawal or field correction, at Nephron’s expense. Unless such recall is caused solely by the negligence, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron shall be responsible for all of the costs and expenses of such recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Drug Substance and notification administration of the recall and such other actual costs as may be related to those persons whom Nephron deems appropriate)the recall. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONPrior to any reimbursements pursuant to this Section, the Party claiming any reimbursement shall provide the other Party with reasonably acceptable documentation of all reimbursable costs and expenses.

Product Recalls. Each In the event (a) any government authority issues a directive or order that a Product manufactured or supplied by Manufacturer hereunder be recalled; or (b) a court of competent jurisdiction orders such a recall; or (c) Customer reasonably determines that any such Product should be recalled, or (d) Manufacturer, reasonably determines that any such Product should be recalled, the parties shall take all appropriate corrective actions to best preserve the Product’s good will and reputation. If a recall is due to (a) or (b), Manufacturer and Customer shall split evenly the costs of such recall until primary responsibility for the cause of the recall is determined, at which time the party promptly primarily responsible for the cause of the recall shall notify assume responsibility for all such costs and expenses and shall reimburse the other if party for any Batch costs and expenses incurred by such party. If a recall is due to (c) or (d), the party calling for the recall shall initially bear the expenses of the Product recall until primary responsibility for the cause of the recall is alleged or proven to be determined, at which time the subject of a recall, market withdrawal or correction. Nephron shall be party primarily responsible for coordinating any recall, market withdrawal or field correction the cause of the Product, recall shall assume responsibility for all such costs and recall, market withdrawal or correction expenses and shall be conducted in accordance reimburse the other party for all costs and expenses incurred by such party. If a recall is due to nonconformance with the provisions of cGMP regulations, failure to meet the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating to such recallSpecifications, market withdrawal or field correction. RevitaLid shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) in connection with such recall, market withdrawal or field correction, at Nephron’s expense. Unless if such recall is caused solely by otherwise due to the negligenceactions or negligence of Manufacturer, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron Manufacturer shall be considered the party primarily responsible in which case Manufacturer shall be responsible for all of the costs and expenses of such recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recall, market withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Drug Substance and notification of the recall to those persons whom Nephron deems appropriate)and shall hold Customer, its employees, representatives and customers harmless. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONFor purposes of this Agreement, the expenses of recall shall include, without limitation, the expenses of notification of customers, the expenses of return and/or destruction of the recalled Product, any necessary Product rework expense, any legal expenses incurred and other reasonable related expenses.

Product Recalls. Each party shall promptly shall notify the other party if any Batch batch of the Product is alleged or proven to be the subject of a recall, market withdrawal or correctioncorrection ordered by the FDA or any other regulatory authority in the Territory. Nephron The parties shall be responsible for coordinating any cooperate in good faith to handle and dispose of such recall, market withdrawal or field correction correction; provided, however, that in the event of the Product, and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating disagreement as to any matters related to such recall, market withdrawal or field correction, ORPHAN’S decision shall prevail. RevitaLid ORPHAN shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) in connection with bear [ * ] costs of any such recall, market withdrawal or field correction, at Nephron’s expense. Unless such recall is caused solely by the negligence, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron shall be responsible for all of the costs and expenses of correction unless such recall, market withdrawal or field correction was solely the result of Catalytica’s negligence or willful misconduct, or breach of Article 8.1(b), in which case Catalytica shall [ * ] bear [ * ] cost of administering such recall, market withdrawal, or correction. In the ; provided, however, in no event a shall Catalytica’s aggregate liability with regard to any recall, market withdrawal or field correction is necessary because exceed [ * ]. Catalytica will not bear the cost for recalls made as a result of RevitaLid’s breach of errors that could have been detected by ORPHAN through acceptance and rejection testing as outlined in this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear Article 9. ORPHAN shall in all reasonable costs associated with such recallevents be responsible for conducting any recalls, market withdrawal withdrawals or field correction (including but not limited corrections with respect to costs associated with receiving and administering the recalled Drug Substance and notification of the recall to those persons whom Nephron deems appropriate)Product. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS EXHIBIT DOCUMENT, MARKED BY BRACKETS, HAS BEEN REDACTED OMITTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Product Recalls. Each party In the event of a field alert, recall, product withdrawal, or field correction of a Product (collectively, “Recall”), ONYX shall be responsible for the coordination of Recall activities. ONYX shall promptly shall notify the other CAMBRIDGE if any Batch of the Product is alleged or proven to be the subject of a recall, market withdrawal or correction. Nephron shall be responsible for coordinating any recall, market withdrawal or field correction of the Product, Recall and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. Nephron shall provide RevitaLid CAMBRIDGE with a copy of all documents relating to such recall, market withdrawal or field correctionRecall. RevitaLid CAMBRIDGE shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) ONYX in connection with such recall, market withdrawal or field correctionany Recall, at NephronONYX’s reasonable expense. Unless such recall To the extent the Recall is due to or caused solely by (i) the negligence, omission negligence or willful misconduct of RevitaLid CAMBRIDGE (or solely any of its directors, employees, agents, Approved Subcontractors or Affiliates), (ii) a breach by RevitaLidCAMBRIDGE of any of the terms of this Agreement or the Quality Agreement (including, but not limited to the Product being Misbranded or Adulterated as such term is defined by any applicable Regulatory Authority), or (iii) any other matter for which CAMBRIDGE is obligated to indemnify ONYX under Section 7.6, wherein the use of the Product has resulted in bodily injury or poses actual and imminent danger of causing bodily injury, CAMBRIDGE shall pay for or reimburse ONYX for all direct costs associated with such Recall, including a Product already delivered to ONYX’s customers, and further agrees to reimburse ONYX for amounts ONYX is legally required to pay or pays in the exercise of ONYX’s commercially reasonable discretion related to the recalled Product, including any notification, shipping, destruction, packaging and handling charges of any replacement Product and ONYX Materials. Further, CAMBRIDGE shall replace all Material used to Manufacture the Recalled Product at no charge to ONYX if the Material subject to the recall is not capable of being re-introduced in accordance with cGMPs, the Specifications and Applicable Laws. To the extent the Recall is caused by reasons other than CAMBRIDGE’s negligence, willful misconduct or breach of its warranties this Agreement, the Quality Agreement or obligations any warranty set forth in Section 7.2 or an obligation of indemnity to ONYX under this Agreement, Nephron ONYX shall be responsible for pay all of the costs and expenses of such recall, market withdrawal or field correction. In the event a recall, market withdrawal or field correction is necessary because of RevitaLid’s breach of this Agreement or its negligence, omission or willful misconduct, RevitaLid will bear all reasonable costs associated with such recallRecall as described above. ONYX will use commercially reasonable efforts to mitigate the costs, market withdrawal or field correction (including but not limited expenses and other damages relating to costs associated with receiving and administering the recalled Drug Substance and notification of the recall to those persons whom Nephron deems appropriate). THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONany Recall.

Product Recalls. Each party promptly shall notify Should any Product's defect or any Regulatory Authority action attributable to a Product's defect require (a) the other if recall, destruction or withholding from market of any Batch of the Product is alleged (a "Recall") or proven to be the subject (b) institution of a recallfield correction of any Product (a "Field Correction"), market withdrawal Hospira and ICU must notify each other within two Business Days of becoming aware of such defect or correctiongovernmental action. Nephron If a Recall or Field Correction is deemed necessary by any Regulatory Authority, by ICU in the United States, or by Hospira outside the United States, then ICU and Hospira shall provide the appropriate level of support for the Recall or Field Correction as shown in Exhibit 4.3. ICU will consider in good faith Hospira's suggestions and Hospira and ICU will work together to develop the strategy for carrying out the Recall or Field Correction. Hospira and ICU will each use commercially reasonable efforts to support such strategy. Hospira shall be responsible for coordinating any recall, market withdrawal or field correction of the Product, and recall, market withdrawal or correction shall be conducted in accordance with the provisions of the Quality Agreement. Nephron shall provide RevitaLid with a copy of all documents relating to such recall, market withdrawal or field correction. RevitaLid shall cooperate with Nephron (including providing Nephron with all data, information and documents requested by Nephron) in connection with such recall, market withdrawal or field correction, at Nephron’s expense. Unless such recall is caused solely by the negligence, omission or willful misconduct of RevitaLid or solely by RevitaLid’s breach of its warranties or obligations under this Agreement, Nephron shall be responsible for all of the costs and expenses of such recallRecall or Field Correction to the extent such Recall or Field Correction is attributable to any negligent acts or omissions or willful misconduct by Hospira, market withdrawal its Affiliates or field correction. In the event a recalltheir respective officers, market withdrawal directors, employees and agents, or field correction is necessary because of RevitaLid’s Hospira's breach of this Agreement Agreement, and ICU shall be responsible for the costs and expenses of such Recall or its negligenceField Correction in all other circumstances. ICU shall be responsible as manufacturer for the preparation of any required reports or information that under applicable Laws must be submitted to a Regulatory Authority with respect to any Product complaints, omission adverse events, Product withdrawals, Recalls or willful misconduct, RevitaLid Field Corrections or other corrective actions. Hospira will bear all reasonable costs associated be responsible for submitting such reports to Regulatory Authorities outside the United States. Any information of any nature disclosed by one Party to the other in connection with such recall, market withdrawal Recall or field correction (including but not limited to costs associated with receiving and administering the recalled Drug Substance and notification Field Correction shall be considered Confidential Information of the recall to those persons whom Nephron deems appropriate). THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONdisclosing Party.