ORDERS, Delivery, and Acceptance. 7.1 Urology Company shall order Product from Columbia in full batches of approximately 25,000 units, for which Urology Company shall provide Columbia with a Purchase Order at least six months before the requested delivery date, provided, however, that Columbia and Urology Company shall use all commercially reasonable efforts to assign to Urology Company, or terminate, the Mipharm Agreement in the Territory. 7.2 Columbia shall within ten (10) days of the receipt of any Purchase Order from Urology Company give written notice to Urology Company if it cannot fulfill such Purchase Order and the provisions of Clause 12.1 shall apply. 7.3 In the event of a conflict between the terms and conditions of any Purchase Order and this Agreement, the terms and conditions of this Agreement shall prevail. 7.4 All Product supplied under this Agreement shall be delivered Ex Works (INCOTERMS 2000) Columbia's or its contract manufacturing and/or distribution facility in Europe and shall be accompanied by a written Certificate of Analysis signed by the Qualified Person confirming that such quantity of Product meets the Specification. Urology Company shall secure transport and insurance with its own providers at its sole cost and expense. Urology Company shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Product purchased by Urology Company hereunder which amounts shall be separately set forth on Columbia's invoices to Urology Company. Title and risk of loss and damages to Product purchased by Urology Company hereunder shall pass to Urology Company upon receipt of the Product by the carrier designated by Urology Company at Columbia's contract manufacturing and/or distribution facility. 7.5 Following receipt of a shipment of Product from Columbia, Urology Company or its designated agent shall, within thirty (30) days, carry out a visual inspection of such shipment to ensure that Packaging and Labelling of Product has taken place in accordance with the Specification and is accompanied by an associated Certificate of Analysis and if Urology Company determines in its sole discretion that it has not so taken place it shall promptly notify rejection of shipment to Columbia in writing. Subject to the provisions of Clause 7.6, if Urology Company does not notify Columbia of rejection of such shipment within such thirty (30) days, such shipment of Product shall be deemed to have been accepted. 7.6 Notwithstanding the foregoing, Columbia shall remain liable to Urology Company for any latent defect that subsequently is discovered that renders the Product unsaleable, if such defect is due to the failure of the Product to meet Specification and/or cGMP and provided that Urology Company immediately inform Columbia by a notice in writing of such defect and rejection of the relevant shipment not later than ten (10) days from the date of discovery of such latent defect and the provisions of Clauses 7.7 and 7.8 shall apply to any such rejected Product . 7.7 Within ten (10) days of receipt by Columbia of a notice of rejection from Urology Company in accordance with this Clause 7 Columbia shall indicate in writing to Urology Company whether Columbia is issuing a return authorisation or not. In the event that a return authorisation is so issued Urology Company shall return to Columbia at Columbia's expense the quantities of Product in question and Columbia shall replace such quantities as soon as reasonably practicable thereafter. If the payment in respect of such quantities is outstanding, it shall be postponed until such replacement quantities are received and accepted by Urology Company in accordance with this Clause 7. 7.8 After receipt of any rejection notice from Urology Company pursuant to this Clause 7, if Columbia does not issue a return authorisation, Columbia shall analyze any batch of Product rejected by Urology Company for nonconformity with the Specifications within thirty (30) days of receipt of such notice, and present its findings with respect to such Product to Urology Company. If such tests confirm non-conformity with the Specification Columbia shall supply to Urology Company (at Columbia's cost and expense) a conforming batch as soon as reasonably practical in the same quantity as the rejected batch and shall reimburse Urology Company for any out of pocket costs or expenses incurred by Urology Company including, but not limited to, shipping charges in relation to such non-conforming batch. If the Parties cannot agree on whether the batch of Product in question conforms to the Specifications, an independent qualified laboratory reasonably acceptable to both Parties, and at a cost equally shared by both Parties, shall analyze both Urology Company's and Columbia's samples of Product in question, and the definitive results of such laboratory shall be binding on the Parties. If the batch of Product in question is determined to be nonconforming, such nonconforming Product shall be held for Columbia's disposition, or shall be returned to Columbia, in each case at Columbia's expense, as directed by Columbia no later than fifteen (15) days following such determination. Columbia shall replace each nonconforming batch of Product, or the nonconforming portion thereof, with conforming Product as soon as reasonably practical after receipt of notice of rejection thereof. If the batch of Product in question is determined to be conforming and provided that the Certificate of Analysis did not indicate it to be nonconforming, such Product shall be returned to Urology Company at Urology Company's cost and expense. 7.9 All product supplied by Columbia to Urology Company under this Agreement shall be supplied with a minimum remaining shelf life of thirty (30) months.
Appears in 2 contracts
Samples: License and Supply Agreement (Columbia Laboratories Inc), License and Supply Agreement (Columbia Laboratories Inc)
ORDERS, Delivery, and Acceptance. 7.1 Urology Company 5.1 CDW shall order Product from Columbia in full batches place all purchase orders via facsimile, e-mail, electronic data interchange or such other means acceptable to CDW. "Purchase orders, including any changes, shall be considered valid only if i>sued by a representative of approximately 25,000 unitsCDW's Purchasing Department. Supplier shall, for which Urology Company shall provide Columbia with within twenty-four (24) hours after receipt of CDW's purchase order, submit to CDW a Purchase Order at least six months Receipt Acknowledgement. The Purchase Order Receipt Acknowledgement shall note any adjustments, including back orders, price and quantity relating to the order but shall not alter or change any other term or condition of this Agreement.
5.2 Supplier shall include the purchase order number and purchase order line number on all correspondence sent to CDW with respect to a purchase. Failure to include a purchase order number on an invoice may result in non-payment of the invoice. All boxes containing CDW's orders must also have the purchase order number visible on the shipping label. If Supplier drop ships the Products directly to the End-User, Supplier must place CDW's logo on the packing slip.
5.3 [***]
5.4 Supplier shall use best efforts to deliver the Products on or before the requested delivery dates specified on the purchase order. If Supplier cannot deliver the Products on or before the dates specified on the purchase order, Supplier shall, prior to the delivery date, provided, however, that Columbia and Urology Company shall use all commercially reasonable efforts issue an updated delivery date to assign to Urology Company, or terminate, the Mipharm Agreement in the TerritoryCDW.
7.2 Columbia shall within ten (10) days of the receipt of any Purchase Order from Urology Company give written notice to Urology Company if it cannot fulfill such Purchase Order and the provisions of Clause 12.1 shall apply.
7.3 In the event of a conflict between the terms and conditions of any Purchase Order and this Agreement, the terms and conditions of this Agreement shall prevail.
7.4 All Product supplied under this Agreement 5.5 Supplier shall be delivered Ex Works (INCOTERMS 2000) Columbiaresponsible for providing adequate packaging, tagging, labeling, packing, shipping and billing reasonably requested by CDW and/or established by applicable laws, regulations, carrier tariffs and classification. Supplier shall ship only the quantities ordered by CDW and Supplier shall make no substitutions without CDW's or its contract manufacturing and/or distribution facility prior written approval. Supplier may make partial deliveries of CDW's orders. CDW may, in Europe and shall be accompanied by a written Certificate of Analysis signed by the Qualified Person confirming that such quantity of Product meets the Specification. Urology Company shall secure transport and insurance with its own providers at its sole cost and expensediscretion, refuse over shipments. Urology Company Supplier shall pay all freightcommunicate any shipment discrepancies to CDW in a timely manner, insurance charges, taxes, import and export duties, inspection fees and other charges applicable If such discrepancies are not communicated to the sale and transport of Product purchased by Urology Company hereunder which amounts shall be separately set forth on Columbia's invoices to Urology Company. Title and risk of loss and damages to Product purchased by Urology Company hereunder shall pass to Urology Company upon receipt of the Product by the carrier designated by Urology Company at Columbia's contract manufacturing and/or distribution facility.
7.5 Following receipt of a shipment of Product from Columbia, Urology Company or its designated agent shall, CDW within thirty (30) days, carry out a visual inspection of such shipment to ensure that Packaging and Labelling of Product has taken place in accordance with the Specification and is accompanied by an associated Certificate of Analysis and if Urology Company determines in its sole discretion that it has not so taken place it shall promptly notify rejection of shipment to Columbia in writing. Subject to the provisions of Clause 7.6, if Urology Company does not notify Columbia of rejection of such shipment within such thirty (30) days, such shipment of Product shall be deemed to have been accepted.
7.6 Notwithstanding the foregoing, Columbia shall remain liable to Urology Company for any latent defect that subsequently is discovered that renders the Product unsaleable, if such defect is due to the failure of the Product to meet Specification and/or cGMP and provided that Urology Company immediately inform Columbia by a notice in writing of such defect and rejection of the relevant shipment not later than ten (10) days from the date of discovery of such latent defect and shipment to CDW then the provisions of Clauses 7.7 and 7.8 matter shall apply to any such rejected Product be deemed .losed.
7.7 Within ten 5.6 CDW reserves the right to cancel or reschedule an order without incurring any cancellation or rescheduling fee as long as the Products have not been shipped. CDW may cancel or reschedule an order by facsimile, e-mail, or such other means acceptable to CDW. Supplier shall within twenty-four (1024) days of receipt by Columbia of a notice of rejection from Urology Company in accordance with this Clause 7 Columbia shall indicate in writing to Urology Company whether Columbia is issuing a return authorisation or not. In the event that a return authorisation is so issued Urology Company shall return to Columbia at Columbia's expense the quantities of Product in question and Columbia shall replace such quantities as soon as reasonably practicable thereafter. If the payment in respect of such quantities is outstanding, it shall be postponed until such replacement quantities are received and accepted by Urology Company in accordance with this Clause 7.
7.8 After receipt of any rejection notice from Urology Company pursuant to this Clause 7, if Columbia does not issue a return authorisation, Columbia shall analyze any batch of Product rejected by Urology Company for nonconformity with the Specifications within thirty (30) days hours of receipt of such noticenotice forward to CDW a written confirmation of any such cancelled or rescheduled order. Notwithstanding the foregoing, CDW shall not be responsible for Supplier's failure to cancel the order on its system. Furthermore, CDW shall not be liable for any shipping or handling charges associated with a cancelled or rescheduled order.
5.7 All Products shall be subject to final inspection and present acceptance by CDW and any Products that do not comply with this Agreement, the purchase order or which are damaged or contain defective material or workmanship may be rejected by CDW. Title to Products will not pass to CDW (i) until inspection and acceptance of the Products at CDW's location, or (ii) if the Products are shipped directly to an End-User until the End-User inspects and accepts the Products. Title to software shall remain with Supplier or its findings with respect licensor. [***] β Indicates omission pursuant to such Product to Urology Companya request for confidential treatment. If such tests confirm non-conformity The omitted text has been filed separately with the Specification Columbia Securities and Exchange Commission.
5.8 [***]
5.9 Supplier shall supply comply with CDW's Freight Receiving Policies and Procedures. Supplier should contact CDW ' s Purchasing Department to Urology Company (at Columbia's cost and expense) obtain a conforming batch as soon as reasonably practical in the same quantity as the rejected batch and shall reimburse Urology Company for any out of pocket costs or expenses incurred by Urology Company including, but not limited to, shipping charges in relation to such non-conforming batch. If the Parties cannot agree on whether the batch of Product in question conforms to the Specifications, an independent qualified laboratory reasonably acceptable to both Parties, and at a cost equally shared by both Parties, shall analyze both Urology Company's and Columbia's samples of Product in question, and the definitive results current version of such laboratory shall be binding on the Parties. If the batch of Product in question is determined to be nonconforming, such nonconforming Product shall be held for Columbia's disposition, or shall be returned to Columbia, in each case at Columbia's expense, as directed by Columbia no later than fifteen (15) days following such determination. Columbia shall replace each nonconforming batch of Product, or the nonconforming portion thereof, with conforming Product as soon as reasonably practical after receipt of notice of rejection thereof. If the batch of Product in question is determined to be conforming Policies and provided that the Certificate of Analysis did not indicate it to be nonconforming, such Product shall be returned to Urology Company at Urology Company's cost and expenseProcedures.
7.9 All product supplied by Columbia to Urology Company under this Agreement shall be supplied with a minimum remaining shelf life of thirty (30) months.
Appears in 2 contracts
Samples: Distributor Agreement (Sand Hills, Inc), Distributor Agreement (Sand Hills, Inc)