Common use of Supply Clause in Contracts

Supply. ORGENTEC shall supply Proprius with ORG 548 Anti-MCV 96-well titer plates and associated reagents (“Plates”). During the Term, ORGENTEC agrees to sell and supply to Proprius such quantities of Kits as may be set forth on purchase orders placed by Proprius in accordance with this Section 2.7. Proprius shall order Kits by submitting written purchase orders to ORGENTEC specifying the quantity of Kits ordered, the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each purchase order to ORGENTEC at least 30 days in advance of the desired shipment date specified in such purchase order. ORGENTEC shall make each shipment of Kits in the quantity and on the shipment date specified for it on Proprius’ purchase order, via the mode(s) of transportation and to the destination specified on such purchase order. Any shipment shall be delivered [EXW ](Incoterms 2000). Any purchase orders for Kits submitted by Proprius to ORGENTEC shall reference this Agreement and shall be governed exclusively by the terms contained herein. The parties hereby agree that the terms and conditions of this Agreement shall supersede any term or condition in any order, confirmation or other document furnished by Proprius or ORGENTEC that is in any way inconsistent with these terms and conditions, ORGENTEC agrees to use its commercially reasonable efforts to ensure that Kits ordered by Proprius hereunder shall be delivered on the scheduled delivery dates set forth in the relevant purchase orders. Promptly upon receipt of a shipment, Proprius shall inspect such shipment. Proprius shall notify ORGENTEC in writing and may reject any portion of any shipment of Plates if such portion of any shipment does not conform to the applicable specifications established by ORGENTEC for the Plates, as in effect from time to time. If Proprius does not notify ORGENTEC of any such deficiency of the shipment within 7 days upon receipt, the shipment shall be deemed approved, except for such deficiencies that were not apparent at the time of the inspection. The initial approval is however based on a visual inspection of the plates/kits and a standard QC check to assure performance specifications of a limited sample of the purchased goods are met. Any change in or loss of performance compared to the product specifications over time on the rest of the purchased plates/kits would fall under ORGENTEC’S product warranty. In case of a presumed lack of performance, Proprius would, if available and to the extent permitted by applicable laws and commercially reasonable provide ORGENTEC with patient samples, which seem to have resulted in questionable or wrong results, so that ORGENTEC can use them for their internal QC of the product which did not fulfill the Proprius QC or performance specifications. If the total available supply of Kits is insufficient to meet the requirements of Proprius and ORGENTEC’s other customers, ORGENTEC shall be under no obligation to meet the order by Proprius but agrees that, in allocating the available supply of Kits while such shortage is in effect, ORGENTEC will give Proprius the same “high” priority that ORGENTEC extends to any of its other comparable customers for Kits.

Appears in 3 contracts

Sources: License Agreement (Exagen Diagnostics Inc), License Agreement (Exagen Diagnostics Inc), License Agreement (Exagen Diagnostics Inc)

Supply. ORGENTEC 4.1 Where the Seller accepts delivery nominations at Malaysia port, all such deliveries shall supply Proprius with ORG 548 Antibe within the port limits of Malaysia, unless delivery outside of such port limits is agreed in writing by the Seller. 4.2 Where the Seller accepts delivery nominations at other parts, all such deliveries shall also be within the port limits of such other parts, unless delivery outside of such port limits of such other ports is agreed in writing by the Seller. 4.3 All deliveries under a Contract shall be made ex-MCV 96-well titer plates and associated reagents (“Plates”). During the Term, ORGENTEC agrees to sell and supply to Proprius such quantities of Kits as may be set forth on purchase orders placed by Proprius light/barge in accordance with this Section 2.7. Proprius shall order Kits the instructions given by submitting written purchase orders to ORGENTEC specifying the quantity of Kits ordered, Buyers or the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each purchase order to ORGENTEC at least 30 days in advance Master of the desired shipment date specified in such purchase order. ORGENTEC shall make each shipment of Kits in the quantity and on the shipment date specified for it on Proprius’ purchase orderVessel, via the mode(s) of transportation and subject to the destination specified on Seller’s agreement to such purchase order. Any shipment instructions, which agreement shall be delivered [EXW ](Incoterms 2000). Any purchase orders reached before commencement of the time for Kits submitted by Proprius to ORGENTEC shall reference this Agreement and shall be governed exclusively delivery by the terms contained hereinSeller under the Contract. The parties hereby agree that the terms and conditions of this Agreement shall supersede any term or condition in any order, confirmation or other document furnished by Proprius or ORGENTEC that Seller is in any way inconsistent with these terms and conditions, ORGENTEC agrees entitled to use its commercially reasonable efforts to ensure that Kits ordered by Proprius hereunder shall be delivered on the scheduled suspend delivery dates set forth in the relevant purchase orders. Promptly upon receipt of a shipment, Proprius shall inspect such shipment. Proprius shall notify ORGENTEC in writing and may reject any portion of any shipment of Plates if such portion of any shipment does not conform to the applicable specifications established by ORGENTEC for Marine Fuel under the PlatesContract until such agreement is reached, as in effect and if no such agreement is reached within fourteen (14) days from time to time. If Proprius does not notify ORGENTEC of any such deficiency of the shipment within 7 days upon receipt, the shipment shall be deemed approved, except for such deficiencies that were not apparent at the time of the inspection. The initial approval is however based on a visual inspection of delivery under the plates/kits and a standard QC check Contract, the Seller shall be entitled to assure performance specifications of a limited sample of terminate the purchased goods are met. Any change in or loss of performance compared contract but without prejudice to the product specifications over time on seller’s right to claim damages from the rest Buyer. 4.4 The buyer shall alone bear the responsibility and risk for the choice of bunker oil and the purchased plates/kits would fall under ORGENTEC’S product warranty. In case of a presumed lack of performance, Proprius would, if available and Seller shall not be obliged to check whether said choice is suitable for the extent permitted by applicable laws and commercially reasonable provide ORGENTEC with patient samples, which seem to have resulted vessel in questionable or wrong results, so that ORGENTEC can use them for their internal QC of the product which did not fulfill the Proprius QC or performance specificationsquestions. If the total available supply oil lives up to its specifications and is generally of Kits is insufficient the same quality as the oil marketed in the geographical area concerned, the Seller shall have performed correctly in this respect. Any information provided by the seller as to meet the requirements characteristics of Proprius Marine Fuel shall not be construed as specifications of Marine Fuel to be delivered under a Contract to the Buyer and ORGENTEC’s other customers, ORGENTEC shall be regarded as ex-gratia only. 4.5 The Buyer shall give the Seller, unless otherwise agreed in or requested by the Seller, at least five (5) days advance notice of requirements (excluding Saturdays, Sundays and Public Holidays and during normal workdays between 09:00 to 17:00 hours by email, telex or telefax, unless waived by the Seller) prior to the time of requested delivery. Such notice shall identify the Buyer and Contract and shall specify all delivery details, including but not limited to, the port, name of vessel, the agent of Vessel its estimated time of arrival, approximate date of delivery, location of vessel, method of delivery and confirmation of the grade and quantity of Marine Fuel ordered. The Buyer or the agent of the Vessel shall give the Seller at least Forty-Eight (48) hours confirmation notice (excluding Saturdays, Sundays and Public Holidays and during normal workdays between 09:00 to 17:00 hours by email, telex or telefax, unless waived by the Seller of the exact quantity of Marine Fuel required and the exact location and exact time at which delivery is required. If the Buyer makes any changes after the confirmations notice, bunker delivery will be subject to point 4.7 Notwithstanding the foregoing, the Buyer shall be liable for any costs or expenses incurred by the Seller resulting from the failure by the Buyer to take delivery of or rejecting in part in full the quantity of Marine Fuel ordered under no obligation to meet the order by Proprius but agrees that, in allocating the available supply of Kits while such shortage is in effect, ORGENTEC will give Proprius the same “high” priority that ORGENTEC extends to any of its other comparable customers for KitsContract.

Appears in 3 contracts

Sources: General Terms & Conditions of Sales, General Terms & Conditions of Sales, General Terms & Conditions of Sales

Supply. ORGENTEC i. For the Commercial Sales Stage, Acutus will provide forecasts covering four (4) quarters for amounts of Coating Materials and the immediate three (3) quarters will be binding on Acutus. ii. In the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion of the forecast for a given quarter, it shall supply Proprius have the option of satisfying its obligation by paying to Biotectix $[***] for such quarter. iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment in accordance with ORG 548 Anti-MCV 96-well titer plates reasonable delivery schedules and associated reagents (“Plates”). During the Term, ORGENTEC agrees to sell and supply to Proprius such quantities of Kits lead times as may be set forth on agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date shall not exceed thirty (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders placed that have been issued by Proprius Acutus in accordance compliance with this Section 2.7Paragraph iii. Proprius Biotectix shall order Kits by submitting written purchase orders to ORGENTEC specifying the quantity of Kits ordered, the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each notify Acutus within ten (10) days after receiving a purchase order to ORGENTEC at least 30 days in advance of the desired shipment date specified in if there is any reason why it cannot accept such purchase order. ORGENTEC In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall make each shipment be deemed accepted. iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of Kits in premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the quantity and on “Coating Material Specifications”). In the shipment date specified for it on Proprius’ purchase order, via the mode(s) event of transportation a Supply Failure by Biotectix and to the destination specified on extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereof, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated Products and to make such purchase orderCoating Materials under the SurModics Agreement. Any shipment If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall be delivered [EXW ]grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (Incoterms 2000). Any purchase orders for Kits submitted by Proprius to ORGENTEC shall reference this Agreement i) identifying qualified manufacturers of products and shall be governed exclusively by the terms contained herein. The parties hereby agree that the terms and conditions of this Agreement shall supersede any term or condition in any order, confirmation or other document furnished by Proprius or ORGENTEC that is in any way inconsistent with these terms and conditions, ORGENTEC agrees to use its relevant components; (ii) using commercially reasonable efforts to ensure assist Acutus in securing supply terms for raw materials that Kits ordered are similar to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License. v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Proprius hereunder Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be delivered on Acutus’ sole source for the scheduled delivery dates set forth SurModics Reagents in the relevant Coatings Materials; provided that (i) SurModics Reagents are available for purchase ordersby Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii) vi. Promptly upon receipt of Acutus shall pay Biotectix for Coating Materials on a shipment, Proprius shall inspect such shipment. Proprius shall notify ORGENTEC in writing and may reject any portion of any shipment of Plates if such portion of any shipment does not conform to the applicable specifications established by ORGENTEC per unit basis as follows for the Platescalendar year 2015: Coating Material Description Price per ▇▇▇▇ ▇ liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as in effect from time evidenced by the most current annual price list which Biotectix provides to time. If Proprius does its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not notify ORGENTEC of any such deficiency exceed the greater of: (a) [***] ([***]%) of the shipment within 7 days upon receipt, pricing for the shipment shall be deemed approved, except preceding calendar year; and (b) the price for such deficiencies that were not apparent at Coating Material as adjusted for the time of increased actual cost to Biotectix for the inspection. The initial approval is however based on a visual inspection of raw materials in the plates/kits and a standard QC check to assure performance specifications of a limited sample of the purchased goods are met. Any change in or loss of performance compared to the product specifications over time on the rest of the purchased plates/kits would fall under ORGENTEC’S product warranty. In case of a presumed lack of performance, Proprius would, if available and to the extent permitted by applicable laws and commercially reasonable provide ORGENTEC with patient samples, which seem to have resulted in questionable or wrong results, so that ORGENTEC can use them for their internal QC of the product which did not fulfill the Proprius QC or performance specifications. If the total available supply of Kits is insufficient to meet the requirements of Proprius and ORGENTEC’s other customers, ORGENTEC shall be under no obligation to meet the order by Proprius but agrees that, in allocating the available supply of Kits while such shortage is in effect, ORGENTEC will give Proprius the same “high” priority that ORGENTEC extends to any of its other comparable customers for Kits.Coating Material

Appears in 1 contract

Sources: Master License Agreement (Acutus Medical, Inc.)

Supply. ORGENTEC 2.1 PharmaPrint and its Affiliates shall have the right and obligation to supply Proprius with ORG 548 Antito AHP and AHP Affiliates one-MCV 96-well titer plates and associated reagents hundred percent (“Plates”)100%) of their requirements of Licensed Products in the Territory. During the Termperiod in which AHP's rights under Paragraph 2.1(a) of the License Agreement (U.S.) are exclusive, ORGENTEC agrees PharmaPrint and its Affiliates agree not to sell and supply to Proprius any third party or market for sale in the Territory a Licensed Product to any party for use or sale in the OTC Market other than AHP. 2.2 By the first day of the first Contract Year, AHP shall provide PharmaPrint with a forecast prepared in good faith of its quarterly requirements of Licensed Products for the following twenty four (24) month period, the initial twelve (12) month thereof being known as the "Initial Forecast". Purchase orders will be placed by AHP corresponding to the first three (3) months of the Initial Forecast. Throughout the term of the Agreement, AHP shall further provide PharmaPrint with a rolling monthly forecast of AHP's anticipated requirements of Licensed Products for the subsequent twelve (12) month period ("Updated Forecast"). The forecasted requirements of Licensed Products in the initial three (3) month Period of the Initial Forecast and each subsequent Updated Forecast shall be binding upon AHP. The remaining period of the Initial Forecast and each subsequent Updated Forecast shall not bind AHP to order or accept such forecasted requirements or any part thereof and shall be only for the purpose of assisting PharmaPrint and its Contractor(s) to plan their manufacturing of Licensed Products for the applicable period. 2.3 AHP shall place purchase orders for each of the Licensed Products with PharmaPrint from time to time specifying the quantities of Kits the Licensed Products desired, and the places to which and the manner and dates by which delivery is to be made; said delivery dates to be no earlier than ninety (90) days from the date of the purchase order unless requested by AHP and agreed to by PharmaPrint. 2.4 PharmaPrint shall acknowledge all purchase orders within ten (10) business days of their receipt. PharmaPrint shall execute all accepted purchase orders by delivery of all ordered quantities of the Licensed Products no later than the delivery dates provided in the purchase orders of AHP to the destination recited therein, unless requested by AHP and agreed to by PharmaPrint. 2.5 To the extent that the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.6 Title and risk of loss will pass to AHP upon delivery of Licensed Products to the designated carrier of AHP at Contractor's manufacturing facility or PharmaPrint's storage facility as set forth in Schedule A or may be set forth on agreed to by the parties. The parties agree that Contractors' facilities shall be domestically located unless otherwise agreed. 2.7 All Licensed Products supplied by PharmaPrint to AHP in response to purchase orders placed by Proprius in accordance with this Section 2.7. Proprius shall order Kits by submitting written purchase orders to ORGENTEC specifying the quantity of Kits ordered, the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each purchase order to ORGENTEC at least 30 days in advance of the desired shipment date specified in such purchase order. ORGENTEC shall make each shipment of Kits in the quantity and on the shipment date specified for it on Proprius’ purchase order, via the mode(s) of transportation and AHP will conform to the destination specified on such purchase order. Any shipment shall be delivered [EXW ](Incoterms 2000). Any purchase orders for Kits submitted by Proprius to ORGENTEC shall reference this Agreement Specifications and shall be governed exclusively accompanied by the terms contained hereinapplicable certificate of analysis. PharmaPrint shall further have the sole responsibility for obtaining all Government Approvals. 2.8 PharmaPrint and/or its Contractor(s) shall procure all active ingredients, inactive ingredients and excipients necessary for the production of the Licensed Products. Title in all such materials shall reside in PharmaPrint. 2.9 The parties hereby agree that initial prices for the terms and conditions of this Agreement shall supersede any term Licensed Products are set forth on Schedule A. All prices for Licensed Products are F.O.B. Contractor's manufacturing or condition PharmaPrint's storage facility as noted in any order, confirmation Schedule A or other document furnished as may be agreed to by Proprius or ORGENTEC that is in any way inconsistent with these terms and conditions, ORGENTEC agrees to use its commercially reasonable efforts to ensure that Kits ordered by Proprius hereunder shall be delivered on the scheduled delivery dates parties. 2.10 Except as set forth in Paragraph 2.16, such prices of each such Licensed Product shall remain fixed for a period of two (2) years from the relevant date of receipt by PharmaPrint of AHP's first purchase ordersorder for each of such Licensed Products. Promptly After such two (2) year period, PharmaPrint may adjust the price of each of the Licensed Products not more than once per Contract Year upon receipt not less than ninety (90) days written notice to AHP, to adjust for increases or decreases in raw material costs ("Raw Materials Costs"), and not more often than once in any Contract Year to adjust for increases or decreases in Contractor's manufacturing costs ("Manufacturing Costs") incurred in the manufacture of the Licensed Product. Any price adjustment hereunder shall apply only to Licensed Products sold in response to orders placed after the date on which such adjustment becomes effective. Increases or decreases in the price of the Licensed Product for Manufacturing Costs in any Contract Year shall not exceed in the aggregate sixty percent (60%) of the increase or decrease in the Consumer Price Index for the related product area published by the U.S. Department of Commerce for the preceding calendar year. PharmaPrint shall cause its Contractors to keep complete and accurate records of all Raw Materials Costs and Manufacturing Costs incurred in the manufacture and delivery of Licensed Products to AHP. PharmaPrint shall provide access to said records during reasonable business hours to a shipmentcertified public accountant selected by AHP, Proprius shall and reasonably acceptable to PharmaPrint, who shall, at AHP's expense, have access to such records deemed by such accountant as reasonably necessary in verifying for AHP, not more often than once each calendar year, such costs incurred by PharmaPrint and/or its Contractors. 2.11 AHP agrees to randomly inspect such shipmentall shipments of Licensed Products to determine whether or not the Licensed Products are in conformity with the Specifications. Proprius shall notify ORGENTEC in writing and may reject In the event that any portion of any the shipment of Plates if such portion of any shipment does not Licensed Products received by AHP fails to conform to the applicable specifications established Specifications, AHP may reject the non-conforming Licensed Products shipment by ORGENTEC for the Plates, as in effect from time giving written notice to time. If Proprius does not notify ORGENTEC PharmaPrint within sixty (60) days of any such deficiency AHP's receipt of the shipment within 7 days upon receiptLicensed Products, which notice shall specify the shipment shall manner in which the Licensed Products fail to meet the Specifications. Failing such notification, AHP will be deemed approvedto have accepted the Licensed Products, and PharmaPrint shall not thereafter be required to indemnify AHP for breach of its warranties under Paragraph 6.3 as to such Licensed Products, except for defects not reasonably discoverable by AHP in such deficiencies inspection. 2.12 In the event PharmaPrint does not agree that were any such Licensed Product failed to meet the Specifications and PharmaPrint and AHP cannot apparent reach agreement with respect to such Licensed Product, PharmaPrint will submit the question of whether the Licensed Product failed to meet the Specifications to an independent laboratory selected by PharmaPrint and approved by AHP for determination. The findings of such laboratory shall be binding upon PharmaPrint and AHP and the cost of such determination shall be paid by the party in error. 2.13 PharmaPrint shall replace any Licensed Product not conforming to the Specifications forthwith, at its expense, or if it is unable to make prompt replacement, PharmaPrint shall either credit AHP's account or refund any payment made on the nonaccepted Licensed Products, depending on AHP's account balance, within forty-five (45) days of AHP's receipt of notice of AHP's nonacceptance. AHP shall return, at PharmaPrint's expense, the nonaccepted Licensed Products to PharmaPrint or its Contractor, as may be agreed by the parties. 2.14 AHP's right to inspect and right to replacement of Licensed Products not conforming to the Specifications shall not preclude AHP from exercising or enforcing any other rights or remedies it may have to redress any loss or damage resulting from PharmaPrint's failure to supply Licensed Products conforming to the Specifications. 2.15 PharmaPrint shall secure access for AHP to the operations and facilities of PharmaPrint and/or its Contractors wherein Licensed Products are manufactured, packaged, tested, labeled, stored and/or shipped. AHP shall have the right to inspect such operations or facilities during normal business hours, and on reasonable prior notice. 2.16 In the event of a Global Shortage affecting at least one Licensed Product, the parties agree to discuss the institution of a temporary adjustment to the price then if effect for such Licensed Product. However, this provision in no way modifies PharmaPrint's obligations with respect to the supply of such Licensed Product during the time of the inspection. The initial approval is however based on a visual inspection of the plates/kits and a standard QC check to assure performance specifications of a limited sample of the purchased goods are met. Any change in such discussions or loss of performance compared to the product specifications over time on the rest of the purchased plates/kits would fall under ORGENTEC’S product warranty. In case of a presumed lack of performance, Proprius would, if available and to the extent permitted by applicable laws and commercially reasonable provide ORGENTEC with patient samples, which seem to have resulted in questionable or wrong results, so that ORGENTEC can use them for their internal QC of the product which did not fulfill the Proprius QC or performance specifications. If the total available supply of Kits is insufficient to meet the requirements of Proprius and ORGENTEC’s other customers, ORGENTEC shall be under no obligation to meet the order by Proprius but agrees that, in allocating the available supply of Kits while such shortage is in effect, ORGENTEC will give Proprius the same “high” priority that ORGENTEC extends to any of its other comparable customers for KitsGlobal Shortage.

Appears in 1 contract

Sources: Supply Agreement (Pharmaprint Inc)

Supply. ORGENTEC shall supply Proprius with ORG 548 Anti-MCV 96-well titer plates 6.1 For so long as a Patent covering a state in the Territory remains valid and associated reagents (“Plates”). During the Termunexpired, ORGENTEC LLI agrees to make and sell to Licensee the Products listed in Exhibit C to this Agreement, and supply any Products of like kind offered by LLI which supercede such listed Products. Such Products shall be made available in amounts sufficient to Proprius such quantities meet one hundred percent (100%) of Kits as may be set forth on purchase Licensee's requirements and at prices and terms that are the most favorable prices and terms for comparable products of similar nature sold by LLI. Licensee shall place orders placed by Proprius for Products from time to time in accordance with its needs, and except as provided below, shall not purchase Products from other suppliers during the term of this Section 2.7. Proprius Agreement, but shall order Kits by submitting written have no continuing obligation to purchase orders Products. 6.2 If LLI is unable to ORGENTEC specifying produce and sell to Licensee Products at prices, quality and quantity reasonably acceptable to Licensee, Licensee shall give notice to LLI in writing of the quantity basis for its non-acceptance, and LLI shall have a period of Kits ordered, the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each purchase order to ORGENTEC at least 30 thirty (30) days in advance which to take corrective action or to seek arbitration, if the dispute is over what constitutes a reasonable price for Products and quality and quantity are not at issue. If at the end of such thirty day period the condition(s) which caused Licensee to give such notice have not been corrected and neither party has requested arbitration pursuant to Section 14 below, then Licensee may elect to obtain Products from another supplier or suppliers, or manufacture Products on his own account, or pursue the same options with products competitive with Products offered by LLI not covered by a Patent of the desired shipment date specified relevant jurisdiction. 6.3 During the pendency of any arbitration proceeding concerning pricing of Products, LLI will continue to sell Products to Licensee at the price in such purchase order. ORGENTEC shall make each shipment of Kits in the quantity and on the shipment date specified for it on Proprius’ purchase order, via the mode(s) of transportation and effect prior to the destination specified on such purchase order. Any shipment shall be delivered [EXW ](Incoterms 2000). Any purchase orders request for Kits submitted by Proprius to ORGENTEC shall reference this Agreement and shall be governed exclusively by the terms contained herein. The parties hereby agree that the terms and conditions of this Agreement shall supersede any term arbitration, or condition in any order, confirmation or other document furnished by Proprius or ORGENTEC that if there is in any way inconsistent with these terms and conditions, ORGENTEC agrees to use its commercially reasonable efforts to ensure that Kits ordered by Proprius hereunder shall be delivered on the scheduled delivery dates set forth in the relevant purchase orders. Promptly upon receipt of a shipment, Proprius shall inspect such shipment. Proprius shall notify ORGENTEC in writing and may reject any portion of any shipment of Plates if such portion of any shipment does not conform to the applicable specifications established by ORGENTEC for the Plates, as in effect from time to time. If Proprius does not notify ORGENTEC of any such deficiency of the shipment within 7 days upon receipt, the shipment shall be deemed approved, except for such deficiencies that were not apparent at the time of the inspection. The initial approval is however based on a visual inspection of the plates/kits and a standard QC check to assure performance specifications of a limited sample of the purchased goods are met. Any change in or loss of performance compared to the product specifications over time on the rest of the purchased plates/kits would fall under ORGENTEC’S product warranty. In case of a presumed lack of performance, Proprius would, if available and to the extent permitted by applicable laws and commercially reasonable provide ORGENTEC with patient samples, which seem to have resulted in questionable or wrong results, so that ORGENTEC can use them for their internal QC of the product which did not fulfill the Proprius QC or performance specifications. If the total available supply of Kits is insufficient to meet the requirements of Proprius and ORGENTEC’s other customers, ORGENTEC shall be under no obligation to meet the order by Proprius but agrees that, in allocating the available supply of Kits while such shortage is price then in effect, ORGENTEC will give Proprius at a price which represents the same “high” priority average of what LLI and Licensee each consider to be a reasonable price. 6.4 Except as provided in Section 6.5, Licensee agrees to return to purchasing Products from LLI if LLI can provide reasonable proof that ORGENTEC extends it is able once again to any meet Licensee's current and reasonably foreseeable needs for Products at prices, quality and quantity reasonably acceptable to Licensee. 6.5 Once Licensee has made a substantial investment in preparation for manufacture of its other comparable customers for KitsProducts himself or through a sublicensee pursuant to paragraph 6.2, should LLI again become able to meet such demand in the future, LLI may be reinstated as sole supplier of the Products under this Section 6 by purchasing at Licensee's original cost the manufacturing capability invested in by Licensee and complying with the conditions of paragraph 6.

Appears in 1 contract

Sources: License Agreement (Elgin Technologies Inc)

Supply. ORGENTEC shall supply Proprius with ORG 548 Anti-MCV 96-well titer plates and associated reagents (“Plates”). During the Term, ORGENTEC agrees a) Subject to sell and supply to Proprius such quantities of Kits as may be set forth on purchase orders placed by Proprius in accordance with this Section 2.7. Proprius shall order Kits by submitting written purchase orders to ORGENTEC specifying the quantity of Kits ordered, the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each purchase order to ORGENTEC at least 30 days in advance of the desired shipment date specified in such purchase order. ORGENTEC shall make each shipment of Kits in the quantity and on the shipment date specified for it on Proprius’ purchase order, via the mode(s) of transportation and to the destination specified on such purchase order. Any shipment shall be delivered [EXW ](Incoterms 2000). Any purchase orders for Kits submitted by Proprius to ORGENTEC shall reference this Agreement and shall be governed exclusively by the terms contained herein. The parties hereby agree that the terms and conditions of this Agreement Agreement, during the Term, Spark shall supersede any term or condition Manufacture and supply the Products exclusively (except for Spark’s and its Affiliates’, licensees’ and collaborators’ requirements in the Spark Territory) to Novartis and its Affiliates and their respective Sublicensees and distributors, and Novartis agrees to purchase from Spark, all of the requirements of Novartis and its Affiliates and their respective Sublicensees and distributors for the Products in the Novartis Territory. (b) Notwithstanding anything to the contrary set forth herein, and subject to Section 2.1(c), the Parties acknowledge and agree that unless otherwise agreed Novartis shall forecast and order its and its Affiliates’ and their respective Sublicensees’ and distributors’ requirements for Drug Product and Diluent Product in terms of number of vials, and that Novartis shall pay for Drug Product and Diluent Product on a per vial basis, provided that in any ordergiven Purchase Order, confirmation or other document furnished by Proprius or ORGENTEC Novartis shall not order more than [**] vials of Drug Product. The Parties acknowledge that is in the actual number of vials of Drug Product may vary among Batches of Drug Substance. Except for Supply Failures, any way inconsistent with these terms and conditions, ORGENTEC agrees to use its commercially reasonable efforts to ensure that Kits variance between the Drug Products ordered by Proprius hereunder Novartis and the Resulting Vials of Drug Product delivered to Novartis in compliance with the Product Warranty shall be delivered subject to the yield mechanism in Section 2.5, and it shall not be a breach of this Agreement if the Resulting Vials of Drug Product is less than the number of vials ordered by Novartis. (c) At any point during the Term Novartis may, in its discretion, notify Spark in writing that it shall forecast and order Batches of Drug Substance, and that Spark shall deliver to Novartis Batches of Drug Substance instead of Drug Product. Novartis shall pay for Batches of Drug Substance on a per batch basis instead of on a per vial basis. Any such notice shall be given at least [**] prior to the first required delivery date of any Batches of Drug Substance. Following such notice, the Parties will mutually agree on the scheduled applicable lead time for delivery, the appropriate delivery dates set forth Incoterm, and the process for moving from placing Purchase Orders for Drug Products to placing Purchase Orders for Batches of Drug Substance and how to handle any open Purchase Orders for Drug Products. If it elects to order Batches of Drug Substance instead of Drug Product, Novartis may also, in the relevant purchase orders. Promptly upon receipt of a shipmentits discretion, Proprius shall inspect such shipment. Proprius shall notify ORGENTEC Spark in writing that it no longer wishes to purchase Diluent Product directly from Spark and/or that it no longer wishes the Fill and Finish Subcontractor to fill and finish the Drug Product, and Spark shall: (i) provide (or procure the provision of) to Novartis or its designated Affiliate or Third Party manufacturer: (A) all technical documentation (including master Batch Records), specifications, procedures and know-how in its possession or control that are reasonably required for the filling, finishing and release testing of Drug Products or Diluent Products (as the case may reject any portion be); and (B) samples of any shipment of Plates if such portion of any shipment does not conform materials relating to the applicable specifications established Manufacture of Drug Products or Diluent Products (as the case may be), including process descriptions, master Batch Records and other related materials, in all cases, to the extent controlled by ORGENTEC for Spark at the Plates, as in effect from time to time. If Proprius does not notify ORGENTEC of any such deficiency date of the shipment within 7 days upon receipt, the shipment shall be deemed approved, except for such deficiencies that were not apparent at the time of the inspection. The initial approval is however based on a visual inspection of the plates/kits and a standard QC check to assure performance specifications of a limited sample of the purchased goods are met. Any change in or loss of performance compared to the product specifications over time on the rest of the purchased plates/kits would fall under ORGENTEC’S product warranty. In case of a presumed lack of performance, Proprius would, if available notice and to the extent permitted by applicable laws necessary or reasonably useful for the Manufacture of Drug Products or Diluent Products (as the case may be); and (ii) make reasonably available to Novartis, relevant scientific and commercially reasonable technical personnel to answer questions, provide ORGENTEC on-site support at one fill and finish facility, and to train personnel from such facilities, and/or provide instruction relating to Manufacture of Drug Products or Diluent Products (as the case may be) during one site visit to each facility for a period of no more than [**] each; and (iii) cooperate with patient samplesNovartis to transition any relevant analytical test methods for the Drug Product and/or Diluent Product to Novartis or its Third Party manufacturer, which seem cooperation shall be limited to have resulted one visit per analytical testing site for a period of no more than [**] each; and (iv) [**]. (d) Notwithstanding anything to the contrary set forth in questionable this Agreement or wrong resultsin the License Agreement, so that ORGENTEC can use them Novartis and its Sublicensees and their respective distributors shall purchase Products only for their internal QC purposes permitted under the License Agreement. In addition, all Diluent Product purchased by Novartis shall be used only for purposes of administration of the product which did not fulfill Drug Substance to end users in accordance with the Proprius QC relevant Regulatory Approval. (e) By [**] (or performance specifications. If such other date as the total available supply Parties may agree in writing), Novartis will determine in its sole discretion whether the vials of Kits is insufficient to meet the requirements of Proprius Diluent Product and ORGENTEC’s other customers, ORGENTEC Drug Product shall be under no obligation to meet delivered labeled with a single universal label as specified by Novartis or as naked vials for the order by Proprius but agrees that, in allocating the available supply of Kits while such shortage is in effect, ORGENTEC will give Proprius the same “high” priority that ORGENTEC extends to any Novartis Territory and provide written notice of its other comparable customers for Kitsdecision to Spark. Spark shall not be obligated to supply any Diluent Product or Drug Product with a single universal label until Novartis has supplied to Spark a PDF file of the applicable single universal label by such date as the Parties may mutually agree in writing following Novartis’ provision of written notice of its decision to Spark.

Appears in 1 contract

Sources: Supply Agreement (Spark Therapeutics, Inc.)

Supply. ORGENTEC 4.1 Where the Seller accepts delivery nominations at Malaysia port, all such deliveries shall supply Proprius with ORG 548 Antibe within the port limits of Malaysia, unless delivery outside of such port limits is agreed in writing by the Seller. 4.2 Where the Seller accepts delivery nominations at other parts, all such deliveries shall also be within the port limits of such other parts, unless delivery outside of such port limits of such other ports is agreed in writing by the Seller. 4.3 All deliveries under a Contract shall be made ex-MCV 96-well titer plates and associated reagents (“Plates”). During the Term, ORGENTEC agrees to sell and supply to Proprius such quantities of Kits as may be set forth on purchase orders placed by Proprius light/barge in accordance with this Section 2.7. Proprius shall order Kits the instructions given by submitting written purchase orders to ORGENTEC specifying the quantity of Kits ordered, Buyers or the desired shipment date for such Plates and any relevant shipping instructions. Proprius shall submit each purchase order to ORGENTEC at least 30 days in advance Master of the desired shipment date specified in such purchase order. ORGENTEC shall make each shipment of Kits in the quantity and on the shipment date specified for it on Proprius’ purchase orderVessel, via the mode(s) of transportation and subject to the destination specified on Seller’s agreement to such purchase order. Any shipment instructions, which agreement shall be delivered [EXW ](Incoterms 2000). Any purchase orders reached before commencement of the time for Kits submitted by Proprius to ORGENTEC shall reference this Agreement and shall be governed exclusively delivery by the terms contained hereinSeller under the Contract. The parties hereby agree that the terms and conditions of this Agreement shall supersede any term or condition in any order, confirmation or other document furnished by Proprius or ORGENTEC that Seller is in any way inconsistent with these terms and conditions, ORGENTEC agrees entitled to use its commercially reasonable efforts to ensure that Kits ordered by Proprius hereunder shall be delivered on the scheduled suspend delivery dates set forth in the relevant purchase orders. Promptly upon receipt of a shipment, Proprius shall inspect such shipment. Proprius shall notify ORGENTEC in writing and may reject any portion of any shipment of Plates if such portion of any shipment does not conform to the applicable specifications established by ORGENTEC for Marine Fuel under the PlatesContract until such agreement is reached, as in effect and if no such agreement is reached within fourteen (14) days from time to time. If Proprius does not notify ORGENTEC of any such deficiency of the shipment within 7 days upon receipt, the shipment shall be deemed approved, except for such deficiencies that were not apparent at the time of the inspectiondelivery under the Contract, the Seller shall be entitled to terminate the contract but without prejudice to the seller’s right to claim damages from the Buyer. 4.4 The buyer shall alone bear the responsibility and risk for the choice of bunker oil and the Seller shall not be obliged to check whether said choice is suitable for the vessel in questions. If the oil lives up to its specifications and is generally of the same quality as the oil marketed in the geographical area concerned, the Seller shall have performed correctly in this respect. Any information provided by the seller as to the characteristics of Marine Fuel shall not be construed as specifications of Marine Fuel to be delivered under a Contract to the Buyer and shall be regarded as ex-gratia only. 4.5 The Buyer shall give the Seller, unless otherwise agreed in or requested by the Seller, at least five (5) days advance notice of requirements (excluding Saturdays, Sundays and Public Holidays and during normal workdays between 09:00 to 17:00 hours by email, telex or telefax, unless waived by the Seller) prior to the time of requested delivery. Such notice shall identify the Buyer and Contract and shall specify all delivery details, including but not limited to, the port, name of vessel, the agent of Vessel its estimated time of arrival, approximate date of delivery, location of vessel, method of delivery and confirmation of the grade and quantity of Marine Fuel ordered. The initial approval is however based on a visual inspection Buyer or the agent of the plates/kits Vessel shall give the Seller at least Forty-Eight (48) hours confirmation notice (excluding Saturdays, Sundays and a standard QC check Public Holidays and during normal workdays between 09:00 to assure performance specifications of a limited sample 17:00 hours by email, telex or telefax, unless waived by the Seller of the purchased goods are metexact quantity of Marine Fuel required and the exact location and exact time at which delivery is required. Any change If the Buyer makes any changes after the confirmations notice, bunker delivery will be subject to point 4.7 Notwithstanding the foregoing, the Buyer shall be liable for any costs or expenses incurred by the Seller resulting from the failure by the Buyer to take delivery of or rejecting in or loss part in full the quantity of performance compared Marine Fuel ordered under the Contract. 4.6 Delivery of Marine Fuel by the Seller to the product specifications over Buyer shall be carried out, inter alia, subject to any regulations, requirements and procedures (including any amendments and revisions thereof) as may be prescribed from time on to time by any government authority at the rest port at which the Seller accepts delivery nominations. The Buyer shall, in any event, be solely responsible for ascertaining, acquainting, itself and complying with inter alia, such regulations, requirements and procedures which are applicable at the Delivery Port and in complying with all relevant berth restrictions and requirements. 4.7 Vessels, including tankers, shall be supplied as promptly as circumstances permit, but Seller shall in no event be liable for any losses or demurrage, whatsoever and howsoever incurred by the Buyer due to or arising in connection with any delay or congestion at the shore terminal, or to any other commitment(s) of available barges in the delivery of the purchased plates/kits would fall Marine Fuel under ORGENTEC’S product warrantythe Contract to the Buyer. This condition will also apply where bunker delivery does not take place during the major holidays and practices of that port or country. 4.8 The Buyer shall be responsible for all connections and disconnections of delivery hose to the Vessel. The Buyer shall render all other necessary assistance and provide sufficient tankage and equipment to receive promptly the delivery under the Contract. Where delivery is undertaken ex-wharf, the buyer shall promptly receive the delivery and withdraw the Vessel from shore terminal or wharf once delivery is completed. 4.9 The risk for the bunker oil shall be transferred successively, as it passes through the fixed receiving connector in the Buyer’s vessel. 4.10 In case addition to the Buyer being responsible for payment of a presumed lack the purchase price and any cost pursuant to point 2.1, the Seller reserves the right to look to the owner of performance, Proprius would, if available and the vessel to the extent permitted the ship owner is responsible pursuant to the legislation of his homeland, and the Seller furthermore reserves the right to safeguard himself by applicable laws Maritime Lien or the like in the vessel to the extent that this is authorized in a jurisdiction where the vessel can be found. It is noted that the rule concerning venue and commercially reasonable provide ORGENTEC with patient samples, which seem to have resulted in questionable or wrong results, so that ORGENTEC can use them for their internal QC choice of the product which did not fulfill the Proprius QC or performance specifications. If the total available supply of Kits is insufficient to meet the requirements of Proprius and ORGENTEC’s other customers, ORGENTEC law mentioned under clause 15.1 (Dispute Resolution Clause) shall be under no obligation considered unwritten in relation to meet the order by Proprius but agrees that, in allocating rights conferred on the available supply of Kits while such shortage is in effect, ORGENTEC will give Proprius Seller according to the same “high” priority that ORGENTEC extends to any of its other comparable customers for Kitspresent point.

Appears in 1 contract

Sources: General Terms & Conditions of Sales