Product Quality Isoprene, (hereinafter referred to as “Product”) supplied and maintained on consignment at Belpre in accordance with Article 6, and will be in accordance with specifications set forth in Exhibit A. Seller will facsimile to the Buyer at time of shipment a Certificate of Analysis (COA). Seller will provide Buyer six (6) months advanced notification if there is a change in the manufacturing process that will affect the material specifications of Product provided to the Buyer. Product produced by the Seller in different plants is viewed as coming from different supply sources and requires separate qualifications. Product to be shipped for the Seller from third parties must be from a third party qualified by the Buyer based on Buyer’s criteria as specified in Exhibit B. Buyer will have the right to confirm each such shipment-conforms to the agreed specification; Seller must obtain approval prior to shipment any material that does not meet the Buyers specifications. If Seller deliveries Product failing to comply with the specifications set out in Exhibit A, Seller will reimburse Buyer for freight expenses associated with such shipment and be entitled at its option to i) require Seller to replace such defective Product at a price not to exceed the invoice value or ii) to reimburse the invoice value of the defective Product. If, Buyer has cause to complain that the quality of Product delivered to it pursuant to the Contract does not comply with the specification set out in Exhibit A, Buyer will give written notice specifying the nature of its complaint and the parties will promptly meet so as to resolve that complaint. In absence of any agreement to resolve the complaint the parties will appoint at their joint cost a mutually acceptable independent surveyor to examine whether the quality of Product as delivered complied with the specifications set forth in Exhibit A. In the absence of any written notice from Buyer to Seller within 30 days after delivery of the Product, the Product shall be deemed to have been delivered and accepted by Buyer in a satisfactory condition and in all respects in accordance with the specifications and Seller shall have no liability to Buyer with respect to that delivery.
Stability Testing Patheon shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees specified in Schedule C. Patheon shall not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails stability testing, Patheon and the Client shall jointly determine the proceedings and methods to be undertaken to investigate the causes of such failure, including which party shall bear the cost of such investigation, provided that Patheon shall not be liable for any such costs unless there has been a failure by it to provide the Manufacturing Services in accordance with the Specifications and cGMPs. Patheon will provide any and all data and results relating to the stability testing upon request by the Client.
Product Testing No later than [***] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [***] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [***] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [***] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [***] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.
Commercial Milestones (a) Within [*****] calendar days after the end of the first Calendar Year in which aggregate annual Net Sales for that Calendar Year for the Licensed Product in the Territory reach any threshold indicated in the Commercial Milestone Events listed below, EverInsight shall notify VistaGen of the achievement of such Commercial Milestone Event and VistaGen shall invoice EverInsight for the corresponding non-refundable, non-creditable Milestone Payment set forth below and EverInsight shall remit payment to VistaGen within [*****] Business Days after the receipt of the invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). Annual Net Sales Milestones for Licensed Product Milestone Payments (in Dollars) (each a “Commercial Milestone Event”):
(1). [*****]
(2). [*****]
(3). [*****]
(4). [*****]
(5). [*****]
(b) For the purposes of determining whether a Net Sales Milestone Event has been achieved, Net Sales of Licensed Product(s) in the Territory shall be aggregated. For clarity, the annual Net Sales Milestone Payments set forth in this Section 8.3 (Commercial Milestones) shall be payable only once, upon the first achievement of the applicable Commercial Milestone Event, regardless of how many times such Commercial Milestone Event is achieved.
(c) If a Commercial Milestone Event in Section 8.3 (Commercial Milestones) is achieved and payment with respect to any previous Commercial Milestone Event in Section 8.3 has not been made, then such previous Commercial Milestone Event shall be deemed achieved and EverInsight shall notify VistaGen within fifteen (15) calendar days of such achievement. VistaGen shall then invoice EverInsight for such unpaid previous Commercial Milestone Event(s) and EverInsight shall pay VistaGen such unpaid previous milestone payment(s) within thirty (30) Business Days of receipt of such invoice.
(d) In the event that, VistaGen believes any Commercial Milestone Event under Section 8.3(a) has occurred but EverInsight has not given VistaGen the notice of the achievement of such Commercial Milestone Event, it shall so notify EverInsight in writing and shall provide to EverInsight data, documentation or other information that supports its belief. Any dispute under this Section 8.3(d) (Commercial Milestones - subsection (d)) that relates to whether or not a Commercial Milestone Event has occurred shall be referred to the JSC to be resolved in accordance with ARTICLE 3 (Governance) and shall be subject to resolution in accordance with Section 14.10 (Dispute Resolution). The Milestone Payments made for each Commercial Milestone Event shall be non-creditable and non-refundable.
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.
Project/Milestones Taxpayer is a food producer and full line grocery store chain, proposing to expand its in- house food manufacturing. In consideration for the Credit, Taxpayer agrees to maintain at least 44 full-time employees, determined on an annual full-time equivalent basis, at its Merced food manufacturing facility; and, to hire full-time employees and invest in a research and development equipment, manufacturing equipment, tenant improvements, and a facility as part of its expansion in Merced and/or Riverside, California (collectively, the “Project”). Taxpayer agrees that for the purposes of satisfying the milestones in Exhibit A (“Milestones”), Taxpayer will only count jobs and investment at its Merced food manufacturing facility and/or a new food manufacturing facility in Riverside, and that no other jobs or investment at any retail or other facility can be counted. For the purposes of calculating the number of full-time employees, no employee transferred from another affiliate, facility, or entity owned, related to, or controlled by the Taxpayer shall be included in the calculation. Taxpayer shall not be entitled to any portion of the Credit if it fails to maintain at least 44 full-time employees, determined on an annual full-time equivalent basis, at its Merced facility for the entire duration of the agreement. Further, Taxpayer agrees to satisfy the Milestones and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of full- time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Wage of California Full-time Employees Hired” and the “Cumulative Average Annual Wage of California Full-time Employees Hired,” Taxpayer may use the wages of any of the full-time employees hired within the required time period. For purposes of calculating the “Minimum Annual Wage of California Full-time Employees Hired” and the “Cumulative Average Annual Wage of California Full-time
Project Specific Milestones In addition to the milestones stated in Section 212.5 of the Tariff, as applicable, during the term of this ISA, Interconnection Customer shall ensure that it meets each of the following development milestones:
6.1 Substantial Site work completed. On or before October 1, 2020, Interconnection Customer must demonstrate completion of at least 20% of project site construction. At this time, Interconnection Customer must submit to Interconnected Transmission Owner and Transmission Provider initial drawings, certified by a professional engineer, of the Customer Interconnection Facilities.
6.2 Delivery of major electrical equipment. On or before October 1, 2020, Interconnection Customer must demonstrate that all generating units have been delivered to Interconnection Customer’s project site.
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.
Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
