Common use of Certain Regulatory Matters Clause in Contracts

Certain Regulatory Matters. If ▇▇▇▇ shall determine, in its sole judgment, that as a result of any law or regulation or interpretation thereof (or compliance by it with any request, guideline or directive) it is not permitted to hold or own asphalt or it would, were it to continue to hold or own asphalt, be or likely to be subject to additional or increased burdens or costs, then it shall notify the Company in writing of such determination and specify in such notice a date (the “Asphalt Transfer Date”) upon which the Company shall purchase from ▇▇▇▇ all asphalt then held by ▇▇▇▇ in any of the Product Storage Facilities at a per Barrel purchase price equal to the applicable price listed on Schedule B hereto; provided that if the basis for giving such notice is that ▇▇▇▇ is or likely may be subject to additional or increased burdens or costs, then such Asphalt Transfer Date shall occur no earlier than six (6) months after the date such notice is given and to the extent that ▇▇▇▇ incurs any such additional or increased burdens or costs after such notice and prior to such Asphalt Transfer Date, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; provided, however, that the Company may give notice to ▇▇▇▇ of the acceleration of the Asphalt Transfer Date to an earlier date, with such earlier date occurring no less than three (3) 35 months following the date of the Company’s notice of acceleration. ▇▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price shall be payable to ▇▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement or any of the other documents related hereto and, to the extent reasonably requested by ▇▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of asphalt from the definition of Products.

Certain Regulatory Matters. If ▇▇▇▇ shall determine, in its sole judgment, that as a result of any law or regulation or interpretation thereof (or compliance by it with any request, guideline or directive) it is not permitted to hold or own asphalt or it would, were it to continue to hold or own asphalt, be or likely to be subject to additional or increased burdens or costs, then it shall notify the Company in writing of such determination and specify in such notice a date (the “Asphalt Transfer Date”) upon which the Company shall purchase from ▇▇▇▇ all asphalt then held by ▇▇▇▇ in any of the Product Storage Facilities at a per Barrel purchase price equal to the applicable price listed on Schedule B hereto; provided that if the basis for giving such notice is that ▇▇▇▇ is or likely may be subject to additional or increased burdens or costs, then such Asphalt Transfer Date shall occur no earlier than six (6) months after the date such notice is given and to the extent that ▇▇▇▇ incurs any such additional or increased burdens or costs after such notice and prior to such Asphalt Transfer Date, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; provided, however, that the Company may give notice to ▇▇▇▇ of the acceleration of the Asphalt Transfer Date to an earlier date, with such earlier date occurring no less than three (3) 35 months following the date of the Company’s notice of acceleration. ▇▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price shall be payable to ▇▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement or any of the other documents related hereto and, to the extent reasonably requested by ▇▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of asphalt from the definition of Products.

Certain Regulatory Matters. If ▇▇▇▇ shall determine, in its sole judgment, that as a result of any law or regulation or interpretation thereof (or compliance by it with any request, guideline or directive) it is not permitted to hold or own asphalt or it would, were it to continue to hold or own asphalt, be or likely to be subject to additional or increased burdens or costs, then it shall notify the Company in writing of such determination and specify in such notice a date (the “Asphalt Transfer Date”) upon which the Company shall purchase from ▇▇▇▇ all asphalt then held by ▇▇▇▇ in any of the Product Storage Facilities at a per Barrel purchase price equal to the applicable price listed on Schedule B hereto; provided that if the basis for giving such notice is that ▇▇▇▇ is or likely may be subject to additional or increased burdens or costs, then such Asphalt Transfer Date shall occur no earlier than six (6) 6 months after the date such notice is given and to the extent that ▇▇▇▇ incurs any such additional or increased burdens or costs after such notice and prior to such Asphalt Transfer Date, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; provided, however, that the Company may give notice to ▇▇▇▇ of the acceleration of the Asphalt Transfer Date to an earlier date, with such earlier date occurring no less than three (3) 35 months following the date of the Company’s notice of acceleration. ▇▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price shall be payable to ▇▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement or any of the other documents related hereto and, to the extent reasonably requested by ▇▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of asphalt from the definition of Products.

Certain Regulatory Matters. If ▇A▇▇▇ shall determine, in its sole judgment, that as a result of any law or regulation or interpretation thereof (or compliance by it with any request, guideline or directive) it is not permitted to hold or own asphalt or it would, were it to continue to hold or own asphalt, be or likely to be subject to additional or increased burdens or costs, then it shall notify the Company in writing of such determination and specify in such notice a date (the “Asphalt Transfer Date”) upon which the Company shall purchase from ▇A▇▇▇ all asphalt then held by ▇A▇▇▇ in any of the Product Storage Facilities at a per Barrel purchase price equal to the applicable price listed on Schedule B hereto; provided that if the basis for giving such notice is that ▇A▇▇▇ is or likely may be subject to additional or increased burdens or costs, then such Asphalt Transfer Date shall occur no earlier than six (6) 6 months after the date such notice is given and to the extent that ▇A▇▇▇ incurs any such additional or increased burdens or costs after such notice NY2-683668 and prior to such Asphalt Transfer Date, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; provided, however, that the Company may give notice to ▇A▇▇▇ of the acceleration of the Asphalt Transfer Date to an earlier date, with such earlier date occurring no less than three (3) 35 months following the date of the Company’s 's notice of acceleration. ▇A▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price shall be payable to ▇A▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇A▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement or any of the other documents related hereto and, to the extent reasonably requested by ▇A▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of asphalt from the definition of Products.

Certain Regulatory Matters. If ▇▇▇▇ (a) As between VSL and Questcor, all regulatory matters regarding the Product shall determineremain under the exclusive control of VSL, subject to the participation by Questcor in its sole judgmentmatters related to the marketing and sale of the Product by Questcor in the Territory. (b) VSL shall furnish Questcor with all efficacy and safety information reasonably requested by Questcor to assist it in promoting and selling the Product in the Territory. Such information shall be treated as confidential information of VSL, and shall not be disclosed to Third Parties without VSL’s period written approval, unless required by law. (c) Beginning as of the Effective Date of this Agreement, each party shall immediately notify the other party of any significant event(s) that affect the marketing of the Product in the Territory, including, but not limited to, adverse drug reactions and governmental inquiries. VSL shall have the responsibility for evaluating such events and reporting such events to applicable regulatory health authorities, if required. (d) Beginning as of the Effective Date of this Agreement, each party shall immediately notify the other party in writing of any order request or directive of a court or other governmental authority to recall or withdraw the Product in any jurisdiction. Each party shall be responsible of the costs associated with a recall or recalls resulting from that area of responsibility associated with such party as described in this Agreement (e.g. if the Product is recalled as a result of any law or regulation or interpretation thereof (or compliance by it a problem associated with any requestthe manufacturing of the Product, guideline or directive) it is not permitted to hold or own asphalt or it would, were it to continue to hold or own asphalt, then VSL shall be or likely to be subject to additional or increased burdens or responsible for such costs, then it shall notify however, if the Company in writing of such determination and specify in such notice Product is recalled due to a date (problem with the “Asphalt Transfer Date”) upon which the Company shall purchase from ▇▇▇▇ all asphalt then held by ▇▇▇▇ in any shipping or handling of the Product Storage Facilities at a per Barrel purchase price equal by Questcor. then Questcor shall be responsible for such costs). (e) Subject to the reimbursement provisions contained in Section 4 (c) of this Agreement, and the other terms and conditions of this Agreement, with respect to Product sold by Questcor in the Territory, Questcor shall be responsible, at its sole cost and expense, for handling all medical inquiries concerning the Product, including without limitation responding to questions concerning permitted and off-label uses of the Product, requests for journal articles, the administration of and response to medical inquiries concerning the Product by consumers, physicians, pharmacists and other health care professionals, including those forwarded by sales representatives and field force personnel promoting the Product in the Territory. (f) Each party shall maintain in full force and effect all necessary licenses, permits and other authorizations required by law to carry out its duties and obligations under this Agreement. Each party shall comply with all laws, ordinances, guidelines, rules and regulations (collectively, “Laws”) applicable price listed on Schedule B heretoto its activities under this Agreement, including without limitation, any requirements of any product license applicable to the Product, if any; provided that if the basis for giving such notice is that ▇▇▇▇ is or likely may be subject to additional or increased burdens or costs, then such Asphalt Transfer Date shall occur no earlier than six (6) months after the date such notice is given and to the extent that ▇▇▇▇ incurs any such additional or increased burdens or costs after such notice and prior to such Asphalt Transfer Date, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; provided, however, that Questcor shall be solely responsible for compliance with those Laws pertaining to the Company may give notice activities conducted by it hereunder (including, without limitation, those Laws that apply to ▇▇▇▇ documentation and records retention pertaining to the distribution and use of samples of the acceleration Product by it under this Agreement), notwithstanding that the FDA may, as a matter of the Asphalt Transfer Date law, be entitled to an earlier date, hold VSL accountable or responsible (whether primarily or secondarily) for failure of Questcor to comply with such earlier date occurring no less than three (3) 35 months following Laws. The parties will reasonably cooperate with one another with the date goal of the Company’s notice of accelerationensuring full compliance with Laws. ▇▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price VSL shall be payable to ▇▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which responsible for all labeling changes to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement or any of the other documents related hereto and, to the extent reasonably requested by ▇▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of asphalt from the definition of ProductsProduct.

Certain Regulatory Matters. If ▇▇▇▇ shall determine, in its sole reasonable judgment, that as a result of (a) the adoption or taking effect of any law Applicable Law, (b) any change in Applicable Law or regulation in the administration, interpretation or interpretation application thereof by any Governmental Authority, (c) the making or compliance by it with issuance of any request, guideline or directivedirective (whether or not having the force of law) it by any Governmental Authority or (d) any interpretation of or proposal to implement any of the foregoing (each, a “Regulatory Event”), ▇▇▇▇ is or would (i) not permitted to hold or own asphalt all or it wouldcertain types of Crude Oil and/or Products, (ii) be unable to perform in any material respect its obligations under this Agreement and/or the other Transaction Documents or (iii) were it to continue to hold or own asphaltsuch Crude Oil and/or Product or perform such obligations, be or likely to be subject to additional or increased burdens or costs, then it shall notify the Company in writing of such determination and specify the Parties shall promptly shall consult in good faith to determine and assess what actions or steps, if any, either Party or both Parties could implement to alleviate, minimize and/or mitigate the effect of any such notice a date (Regulatory Event. If the “Asphalt Transfer Date”) upon which the Company shall purchase from Parties identify actions or steps that, in Aron’s reasonable judgment, can be implemented without resulting in ▇▇▇▇ all asphalt incurring any additional costs or expenses hereunder or under the other Transaction Documents while preserving the economic terms and conditions of this Agreement and the other Transaction Documents (including economic benefits, risk allocation, costs and liabilities), then held by the Parties shall, in good faith and in a commercially reasonable manner, endeavor to implement such actions and steps. If the Parties are unable to identify such actions or steps or are unable to implement any actions and steps that have been so identified, that so long as such Regulatory Event continues, ▇▇▇▇ in any of the Product Storage Facilities at a per Barrel purchase price equal may, by written notice to the applicable price listed Company, elect to terminate this Agreement in the manner provided for in Article 20 on Schedule B hereto; provided that if the basis for giving such notice is that date ▇▇▇▇ shall specify in such notice, which date shall constitute a Termination Date for purposes of Section 20; provided that (unless such Regulatory Event has or is or likely may be subject expected to additional or increased burdens or costs, then become effective at an earlier date) the date specified in such Asphalt Transfer Date notice shall occur no earlier than six at least thirty (630) months days after the date such notice is given and if practicable on the last day of a month; provided further that, to the extent that not inconsistent with or in violation of such Regulatory Event and subject to the expected or actual effective date of such Regulatory Event, ▇▇▇▇ incurs any such additional or increased burdens or costs will specify a Termination Date occurring at least six (6) months but no more than nine (9) months after such notice and prior notice, but is under no obligation to specify such Asphalt Transfer Datelater Termination Date if, such additional or increased burdens or costs shall constitute Ancillary Costs hereunder; providedin Aron’s sole good faith judgment, however, that the Company may give notice doing so presents any risk to ▇▇▇▇ of the acceleration of the Asphalt Transfer Date that it may become subject to an earlier date, with such earlier date occurring no less than three (3) 35 months following the date of the Company’s notice of acceleration. ▇▇▇▇ shall estimate the volume of such asphalt and aggregate purchase price therefor and such aggregate estimated purchase price shall be payable to ▇▇▇▇ as part of the Interim Payment due on such date. Thereafter, ▇▇▇▇ shall promptly determine the volume of such asphalt and the aggregate definitive purchase price therefor (which to the extent applicable will reflect the application of the monthly true up calculations pursuant to Schedule C hereto) and to the extent such aggregate definitive purchase price differs from such aggregate estimated purchase price, the difference shall be included as an adjustment to the first Interim Payment due following the determination of such aggregate definitive purchase price. In addition, from and after the Asphalt Transfer Date, asphalt shall no longer constitute a Product for purposes of this Agreement Regulatory Event or any of the other documents related hereto andadditional material costs, to the extent reasonably requested by ▇▇▇▇, the parties shall make such further amendments to this Agreement and such other documents are may be necessary to reflect the removal of asphalt from the definition of Productsburdens or restrictions as a result thereof.