Scope of Review for Selected Products Sample Clauses

Scope of Review for Selected Products. For each Selected Product reviewed the IRO shall: a. identify the SWP, AWP, WAC, and any other benchmark prices established for the Selected Product during the Reporting Period; b. identify the SWP, AWP, WAC, and any other benchmark prices established for the Selected Product during the prior three Reporting Periods; c. if the SWP, AWP, WAC, or any other benchmark prices for the Selected Product increased or did not decrease over the time period reviewed, the IRO shall identify Xxxxxx’x reasons and rationale for the price increases or price levels; d. identify the AMP, ASP, and, if applicable, Best Price and WAC reported to CMS for the Selected Product during the current Reporting Period and each of the three prior Reporting Periods; e. identify the applicable CPI-U during the current and each of the three prior Reporting Periods; f. identify all third-party entities that sell products that competed with the Selected Product in the current Reporting Period; g. identify all third-party entities that sold products that competed with the Selected Product during each of the three prior Reporting Periods and identify the time period during which each such entity sold a competing product; h. for each Selected Product, the IRO shall evaluate whether the SWP, AWP, WAC and other benchmark prices were established in a manner consistent with Sandoz’s Policies and Procedures relating to Pricing and Contracting Functions, including whether all required approvals were obtained, whether the decision-making process was consistent with Xxxxxx’x Policies and Procedures, and whether all required documentation pertaining to pricing decisions (including price increases) was retained.
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Related to Scope of Review for Selected Products

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications or otherwise mutually agreed upon specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (i) would in any way be injurious to any of the Terminals; (ii) would render any of the Terminals unfit for the proper storage of similar Products; (iii) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (iv) may not be lawfully stored at the Terminals; or (v) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro’s commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Terminal Service Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro’s unfit Products. (b) TLO shall have the right to store compatible Products received for Tesoro’s account with Products belonging to TLO or third parties in TLO’s commingled storage tanks. TLO shall handle Tesoro’s fungible Products in accordance with TLO’s prevailing practices and procedures for handling such Products. The quality of all Products tendered into commingled storage for Tesoro’s account shall be verified either by Tesoro’s refinery analysis or supplier’s certification, such that Products so tendered shall meet TLO’s Product specifications. All costs for such analysis shall be borne solely by Tesoro. TLO shall have the right to sample any Product tendered to the Terminals hereunder. The cost of such sampling shall be borne solely by TLO. All Products returned to Tesoro shall meet or exceed Product specifications in effect on the date the Products are delivered to Tesoro. Notwithstanding any other provision herein, any and all Products that leave the Terminals shall meet all relevant ASTM, EPA, federal and state specifications, and shall not leave the Terminals in the form of a sub-octane grade Product. (c) TLO shall exercise reasonable care to ensure that all Products delivered by third parties into commingled storage with Tesoro’s Products meet applicable Product specifications for such Product that are customary in the location of the Terminal. In the event that Tesoro’s Products are commingled with third-party Products that do not meet or exceed the minimum quality standards set forth in this Agreement or any Terminal Service Order, TLO shall be liable for all loss, damage and cost incurred thereby.

  • Completion of Review for Certain Review Receivables Following the delivery of the list of the Review Receivables and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify the Asset Representations Reviewer if a Review Receivable is paid in full by the Obligor or purchased from the Issuer in accordance with the terms of the Basic Documents. On receipt of such notice, the Asset Representations Reviewer will immediately terminate all Tests of the related Review Receivable, and the Review of such Review Receivables will be considered complete (a “Test Complete”). In this case, the related Review Report will indicate a Test Complete for such Review Receivable and the related reason.

  • Marketing Plan The MCOP shall submit an annual marketing plan to ODM including all planned activities for promoting membership in or increasing awareness of the MCOP. The marketing plan submission shall include an attestation by the MCOP that the plan is accurate and is not intended to mislead, confuse, or defraud the eligible individuals or ODM.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Discontinued Products If a product or model is discontinued by the manufacturer, Contractor may substitute a new product or model if the replacement product meets or exceeds the specifications and performance of the discontinued model and if the discount is the same or greater than the discontinued model.

  • Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

  • Loss Leader; Recycled Products Contractor shall not sell or use any article or product as a “loss leader” as defined in Section 17030 of the Business and Professions Code. If Contractor will sell to the Judicial Council, or use in the performance of this Agreement, goods specified in PCC 12207 (for example, certain paper products, office supplies, mulch, glass products, lubricating oils, plastic products, paint, antifreeze, tires and tire-derived products, and metal products), then with respect to those goods: (i) Contractor shall use recycled products in the performance of this Agreement to the maximum extent doing so is economically feasible, and (ii) upon request, Contractor shall certify in writing under penalty of perjury, the minimum, if not exact, percentage of post consumer material as defined in the PCC 12200, in such goods regardless of whether the goods meet the requirements of PCC 12209.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable. (b) To the extent a recall is required by applicable Law, or due to a potential safety hazard, non-compliance or Serial Defect, which is caused by Supplier, Supplier shall indemnify and hold Buyer harmless from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazard, non- compliance or Serial Defect, except where such consultation would prevent timely notification required by Law.

  • Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the Funder has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).

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