Clinical Supply In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.
Bidder Supplied Samples The Commissioner reserves the right to request from the Bidder/Contractor a representative sample(s) of the Product offered at any time prior to or after award of a contract. Unless otherwise instructed, samples shall be furnished within the time specified in the request. Untimely submission of a sample may constitute grounds for rejection of Bid or cancellation of the Contract. Samples must be submitted free of charge and be accompanied by the Bidder’s name and address, any descriptive literature relating to the Product and a statement indicating how and where the sample is to be returned. Where applicable, samples must be properly labeled with the appropriate Bid or Contract reference. A sample may be held by the Commissioner during the entire term of the Contract and for a reasonable period thereafter for comparison with deliveries. At the conclusion of the holding period the sample, where feasible, will be returned as instructed by the Bidder, at the Bidder’s expense and risk. Where the Bidder has failed to fully instruct the Commissioner as to the return of the sample (i.e., mode and place of return, etc.) or refuses to bear the cost of its return, the sample shall become the sole property of the receiving entity at the conclusion of the holding period.
Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.
(i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field.
(ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.
Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.
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).
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.
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.
Purchase Order Pricing/Product Deviation If a deviation of pricing/product on a Purchase Order or contract modification occurs between the Vendor and the TIPS Member, TIPS must be notified within five (5) business days of receipt of change order. TIPS reserves the right to terminate this agreement for cause or no cause for convenience with a thirty (30) days prior written notice. Termination for convenience is conditionally required under Federal Regulations 2 CFR part 200 if the customer is using federal funds for the procurement. All purchase orders presented to the Vendor, but not fulfilled by the Vendor, by a TIPS Member prior to the actual termination of this agreement shall be honored at the option of the TIPS Member. The awarded Vendor may terminate the agreement with ninety (90) days prior written notice to TIPS 0000 XX Xxx Xxxxx, Xxxxxxxxx, Xxxxx 00000. The vendor will be paid for goods and services delivered prior to the termination provided that the goods and services were delivered in accordance with the terms and conditions of the terminated agreement. This termination clause does not affect the sales agreements executed by the Vendor and the TIPS Member customer pursuant to this agreement. TIPS Members may negotiate a termination for convenience clause that meets the needs of the transaction based on applicable factors, such as funding sources or other needs. Usually, purchase orders or their equal are issued by participating TIPS Member to the awarded vendor and should indicate on the order that the purchase is per the applicable TIPS Agreement Number. Orders are typically emailed to TIPS at xxxxxx@xxxx-xxx.xxx. • Awarded Vendor delivers goods/services directly to the participating member. • Awarded Vendor invoices the participating TIPS Member directly. • Awarded Vendor receives payment directly from the participating member. • Fees are due to TIPS upon payment by the Member to the Vendor. Vendor agrees to pay the participation fee to TIPS for all Agreement sales upon receipt of payment including partial payment, from the Member Entity or as otherwise agreed by TIPS in writing and signed by an authorized signatory of TIPS.
Product Returns Client will have the responsibility for handling customer returns of the Products. Patheon will give Client any assistance that Client may reasonably require to handle the returns.
PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.
