Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval. (b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery. (c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered. (d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility. (e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern. (f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient. (g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 4 contracts
Sources: Supply Agreement (Reliant Pharmaceuticals, Inc.), Supply Agreement (Reliant Pharmaceuticals, Inc.), Supply Agreement (Reliant Pharmaceuticals, Inc.)
Forecasts and Purchase Orders. 7.1 SAGENT has supplied WORLDGEN with an initial non-binding forecast showing SAGENT’s estimated monthly requirements for Product for the twelve-month (a12-months) Following Regulatory Approval of one of period commencing on the Initial Products during anticipated Commercial Launch Date. Promptly following the term of this Agreement, Reliant shall provide to ASL no later than Commercial Launch Date and thereafter on the first day of the first month of during each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements during the term hereof, SAGENT shall deliver to WORLDGEN an updated forecast for the Active Ingredient for twelve-month (12-month) period commencing on the first day of the immediately following calendar quarter and for Product. It is understood that SAGENT before signing a supply agreement with a group purchasing organization will check with WORLDGEN as to the succeeding capacity of DOBFAR to produce such quantities in the time frame required. In addition, SAGENT shall notify WORLDGEN in writing as soon as practicable after it enters into any written agreement with a group purchasing organization with respect to the sale of the Product in the Territory. SAGENT shall place purchase orders for at least the quantity of such Product specified in the first three (3) calendar quarters. Reliant months of each forecast and the remaining nine (9) months shall be a good faith estimate; provided, however, that with respect to forecasts given by SAGENT to WORLDGEN prior to the Approval Date SAGENT will be obligated have no firm obligation to purchase 75% Product prior to the Launch Date. Notwithstanding anything in this Agreement to the contrary, DOBFAR shall guarantee manufacturing capacity and the ability to supply SAGENT [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission [***] of SAGENT’s annual forecasted quantity, and provided that SAGENT has complied with all provisions of this Section 7.1, in the event DOBFAR fails to supply such quantities, and SAGENT is required to pay inability payments to any customer of SAGENT’s, then DOBFAR shall reimburse SAGENT for all such inability payments. In the event that SAGENT’s requests for quantities of Product exceed the quantities of API forecasted provided for in the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approvalforecasts that have been submitted, Reliant DOBFAR shall provide use reasonable commercial efforts to supply such an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approvalincrease in quantity.
(b) Reliant 7.2 SAGENT shall place binding firm purchase orders with WORLDGEN for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed its requirements of Product in full Batch quantities at least ninety (90) days [***] prior to desired the requested date of delivery.
(c) ASL ; provided that, if requested by SAGENT, DOBFAR shall use commercially reasonable efforts to deliver Product at such earlier time as SAGENT reasonably requests. Each firm written purchase order, signed by SAGENT’s duly authorized representative, shall authorize DOBFAR to manufacture such quantities of the Product as are set forth therein. Each purchase order shall be obligated to supply Active Ingredient as ordered by Reliant. To deemed accepted upon receipt, and DOBFAR shall deliver Product in accordance with such purchase order; provided, however, that if the extent quantity of Product set forth in a purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of order exceeds the Quarterly Forecast most recent firm forecast for Product for the relevant quartermonth to which such purchase order relates, ASL then DOBFAR shall use its commercially reasonable best efforts to supply 125% the quantity of Product in excess of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles firm forecasted amount in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any such purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL but shall not be obligated deemed to accept any returns of Active Ingredient other than as a result of have breached this Agreement if it cannot supply such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actexcess Product.
Appears in 2 contracts
Sources: Manufacture and Supply Agreement (Sagent Holding Co.), Manufacture and Supply Agreement (Sagent Holding Co.)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one Gilead will provide to Aspen quarterly rolling [ * ] forecasts for Product commencing [ * ] from the date of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of forecast (each calendar quarter a non-binding good faith estimate (“Quarterly Manufacturing Territory Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval).
(b) Reliant shall place Gilead will provide to Aspen binding purchase orders for Active Ingredient Products that Gilead will purchase. Gilead will be obligated to submit orders that were no less than [ * ] of the quantity stated in the [ * ] of each most recent rolling forecast provided by written or electronic Gilead. Gilead may identify distributors in writing to Aspen who will be authorized to purchase Product directly from Aspen for distribution in the Manufacturing Territory. In such event, such distributor may submit purchase orders to Aspen for Products they will purchase. Each purchase order will state the required delivery date for the Product ordered, which will be no earlier than [ * ] after the date of the purchase order, except as otherwise agreed in writing by the Parties. Aspen will acknowledge each purchase order received from Gilead (or by any other means agreed to by the partiesits distributor) to ASL, which shall be placed at least ninety within five (905) days prior to desired date Business Days of deliveryreceipt.
(c) ASL shall A purchase order from Gilead will be obligated deemed automatically accepted by Aspen for any amount of Product that is equal to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) or less than [ * ] of the Quarterly Forecast amount forecast for the relevant quartermonth in the [ * ] Forecast (“Binding Amount”). If any purchase order for a quarterly period is for more than the Binding Amount, ASL shall Aspen will use its best commercially reasonable efforts to supply 125% fulfill such purchase order as submitted and will include in its response to Gilead the amount (in addition to the Binding Amount) of such purchase [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. order that Aspen will supply. If, despite using [ * ], Aspen cannot fulfill (and thus cannot accept) purchase orders for Product in amounts in excess of the Binding Amount, the Parties will discuss and agree on appropriate steps and both Parties will act reasonably in such circumstance. For purposes of determining whether a quantity in a purchase order is or is not in excess of the Binding Amount, if [ * ] of the quantity orderedof a given Product specified for the relevant quarter in the relevant Forecast equals a fractional number of Batches, then the Binding Amount will be the next whole number of Batches above the fractional number of Batches that is equal to [ * ].
(d) ASL shall maintain minimum inventory levels equal All purchase orders will be sent by Gilead to the binding portion of e-mail address or fax number identified below or identified in writing by Aspen: [ * ] Aspen will acknowledge and either accept or reject purchase orders by email or fax to Materials Management at the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.number set forth below: [ * ]
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the Gilead may cancel any purchase order number, confirms that the Active Ingredient conforms in all ways previously accepted by Aspen by providing Aspen with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Actprior written notice. To the extent of any conflict or inconsistency between this Agreement and If Gilead cancels any purchase order, purchase order releaseAspen will use [ * ] to reallocate its materials, confirmationresources and personnel to other projects (including distribution in the Distribution Territory), acceptance and Gilead will be responsible for paying for (a) [ * ], and (b) [ * ]. This Section 4.3(e) will not apply to mutually agreed changes in production or delivery schedules, or any similar document, the cancellation for which alternative terms of this Agreement shall governare mutually agreed upon by both Parties. It will also not apply for [ * ].
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 2 contracts
Sources: Manufacture and Distribution Agreement, Manufacture and Distribution Agreement (Gilead Sciences Inc)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within thirty (30) days after the Effective Date, Buyer will provide Seller with a written, non-binding Forecast estimating the Products Buyer will purchase during the period of Regulatory Approval, Reliant twelve (12) consecutive calendar months commencing on the Effective Date. Buyer will update such Forecast monthly in order to provide Seller with a twelve month rolling view of prospective purchases by Buyer. The Forecasts shall provide not be binding and only are intended to give the Parties an initial forecast (“Initial Forecast”) estimate of future purchases for the four calendar quarters following Regulatory Approvalplanning purposes.
(b) Reliant Products to be procured hereunder, as well as the Ship Date, shall place binding purchase orders be listed in a Purchase Order issued by Buyer pursuant to this Agreement and subject to the Forecast process listed above. Each Purchase Order shall specifically reference this Agreement, and time is of the essence in connection with the performance of each Purchase Order. Any Purchase Order issued by Buyer to Seller for Active Ingredient by written or electronic purchase order (or by any other means agreed to Products shall be governed in all respects by the partiesterms and conditions of this Agreement. A form of Purchase Order is attached hereto as Exhibit 7. Buyer and Seller agree that, except for non-conflicting administrative terms as provided below, any additional or preprinted terms or conditions on a Purchase Order shall be null, void and of no effect. Each Purchase Order shall specify, in addition to other appropriate information as may be mutually agreed upon:
(i) to ASLname and address of Buyer, or Buyer Affiliate;
(ii) Buyer Purchase Order number and Purchase Order date of issuance;
(iii) name and address of Seller, or as appropriate, Seller Affiliate, which shall be placed at least ninety an Affiliate set forth in the Exhibit 1, that will be providing Product being ordered;
(90iv) days prior incorporation within, by reference, this Agreement;
(v) types and quantities of Product to desired date be furnished by Seller as set forth in Exhibit 2 or as provided in a Quotation;
(vi) applicable prices, charges, and fees with respect to such Product as set forth in Exhibit 2 or as provided in a Quotation;
(vii) location or facility to which Product is to be delivered;
(viii) Ship Date of delivery.Product;
(ix) billing address of the Party responsible for the payment whether it is the Buyer, or Buyer Affiliate to which Buyer intends to resell the Product, if any, and other information required under this Agreement to be included in a Purchase Order;
(x) proper authorization of Buyer or Buyer's agent
(c) ASL shall be Seller is obligated to supply Active Ingredient as ordered accept all Purchase Orders issued by Reliant. To Purchaser under this Agreement except those Purchase Orders which (i) are missing the extent purchase orders material terms required by this Article to be contained in any calendar month exceed One Hundred Fifty percent (150%) a Purchase Order or call for delivery of Products in an amount which is in excess of [*] more than the Quarterly amounts contained in the Forecast for the relevant quartermonth for which such a Purchase Order is issued or (ii) have Ship Dates that materially vary from Standard Intervals. All Purchase Orders shall be deemed to have been accepted by Seller unless (i) Seller notifies Buyer in writing within fifteen (15) business days of receipt of a Purchase Order that it will not accept such Purchase Order and (ii) Seller may rightfully decline to accept such Purchase Order pursuant to the immediately preceding sentence. Any Purchase Order not rightfully rejected shall be deemed to be accepted by Seller. A Purchase Order submitted pursuant to the terms and conditions of this Agreement, ASL and which Seller has accepted, shall use its best efforts constitute an Agreement between Buyer and Seller. Any Purchase Order for which Seller gives timely notice of non-acceptance if non-acceptance is permitted under this Section shall be deemed void. The Product quantities listed on any Purchase Order which conforms to supply 125% the terms and conditions of this Agreement, which are consistent with Forecasts including any permitted variance to such Forecasts and (i) which are not accepted by Seller pursuant to the quantity orderedfirst sentence of this clause (c) or (ii) which are cancelled by Buyer in accordance with Section 5.05(c) hereof, shall be counted toward the Initial Purchase Commitment.
(d) ASL shall maintain minimum inventory levels equal In addition to changes allowed in the Forecast process set forth in Section 5.03 and [*] Confidential Treatment Requested -------------------------------------------------------------------------------- Triton Network Systems, Inc. Confidential 8 Supply Agreement No. _____________ December 21, 1999 G2.0 changes pursuant to Sections 5.05 and 5.06, Buyer may at any time request additions, alterations, deductions, or deviations to a Purchase Order subject to the binding portion condition that such changes and any adjustments resulting from such changes, including but not limited to schedules and prices, shall be mutually agreed upon, and if so agreed, subsequently detailed in a written revision to the applicable Purchase Order ("Change Order") signed by a designated Buyer representative and Seller representative. Change Orders which are processed outside of Seller's customary processing cycle or which require additional work by Seller to comply with such changes may be subject to a reasonable change fee provided Seller has given Buyer a written quote for such change fee and Buyer and Seller have mutually agreed to such change fee in writing prior to or concurrent with execution of the then current Quarterly ForecastChange Order. The Active Ingredient shall be shipped C.I.F. Duty Unpaid If Buyer fails to a Designated Facility accept the change fee. Seller has no obligation to accept or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance comply with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated FacilityChange Order.
(e) All shipments of Active Ingredient shall Purchase Orders may be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredientissued either electronically, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than such as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMPthrough electronic data interchange, or does not otherwise comply with via traditional manual methods, as mutually agreed to by the manufacturing, storage and/or transportation requirements of the ActParties.
Appears in 2 contracts
Sources: Supply Agreement (Triton Network Systems Inc), Supply Agreement (Triton Network Systems Inc)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products during the term of this AgreementOn or before December 1st, Reliant shall provide 2011, Company will submit to ASL no later than the first day of the first month of each calendar quarter Alpex a non-binding good faith estimate forecast of its anticipated needs for Finished Product for the following twelve (12) month period (the “Quarterly Forecast”) by quarter of Reliant’s requirements for ). Company will update the Active Ingredient for the calendar quarter and the succeeding Forecast every three (3) calendar quartersmonths thereafter with a rolling twelve (12) month forecast. Reliant The first four (4) months of each Forecast will serve as a binding obligation to order quantities of Finished Product as stated therein, and will be obligated deemed a Purchase Order (defined below) for purposes of this Agreement. The remaining months of each Forecast will be non-binding estimates of requirements for such period. The Company will commit to purchase 75% of the quantities of API forecasted for required to meet the first two six (26) succeeding calendar quarters months of each Quarterly Forecast. Within Forecast (30) days provided that if Company’s actual orders are lower than forecasted, Alpex will use any excess API obtained by Alpex for future periods and will adjust its future purchases of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory ApprovalAPI accordingly).
(b) Reliant shall place binding Company will issue written purchase orders to Alpex for Active Ingredient by written or electronic purchase order Finished Products (or by any other means agreed to by the parties“Purchase Orders”) to ASL, which shall be placed at least ninety one hundred twenty (90120) days prior to the requested delivery date; provided, however, that if Company issues a Purchase Order less than one hundred twenty (120) days prior to the requested delivery date, Alpex will use its commercially reasonable efforts to meet such delivery date. Unless otherwise agreed by the parties, Purchase Orders will be in increments of full industrial batches of (i) 1.2 million tablets (for the 15mg strength), (ii) 600,000 tablets (for the 30mg strength and (iii) 600,000 tablets (for the 37.5mg strength). Purchase Orders will designate the desired date quantities of deliveryFinished Product, strength, delivery dates, and destination(s). Each Purchase Order will be subject to rejection by Alpex within three five (5) business days of receipt of such Purchase Order; provided, however, that Alpex shall have the right to reject a Purchase Order from Company only to the extent that it is contrary to the provisions of this Agreement. Any Purchase Order that has not been expressly rejected in writing within such five (5) business day period shall be deemed accepted by Alpex.
(c) ASL Alpex shall be obligated accept all Purchase Orders for quantities of Finished Product up to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty one hundred twenty-five percent (150125%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply Forecasted amount. Should any Purchase Order specify quantities of Finished Product in excess of one hundred twenty-five percent (125% %) of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputableForecasted amount, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL Alpex shall not be obligated to accept any returns supply such excess quantities; provided, however, that Alpex shall us commercially reasonable efforts to provide such excess amounts and shall notify Company within fifteen (15) business days after receiving such Purchase Order of Active Ingredient other than as a result of whether it will be able to provide such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actexcess amounts.
Appears in 2 contracts
Sources: Supply Agreement, Supply Agreement (Citius Pharmaceuticals, Inc.)
Forecasts and Purchase Orders. (a) Following Regulatory Approval Subject to Section 2.2(b), KINIKSA shall provide Regeneron in writing with a forecast of one quantities and delivery dates for the requirements of the Initial Products during the term of Finished Product and placebo to be supplied under this Agreement, Reliant shall provide to ASL Agreement (each a “Forecast”) no later than thirty six (36) months prior to the first day requested delivery date and, thereafter, KINIKSA shall provide Regeneron with updated, rolling, thirty-six (36) month Forecasts on a quarterly basis.
(b) The Parties acknowledge that it may be difficult for KINIKSA to provide a Forecast meeting the required lead time set forth in this Section for its first pilot clinical trial and first pivotal clinical study in the Territory (together, the “Initial Clinical Studies”); and, accordingly and notwithstanding the foregoing, KINIKSA shall provide a Forecast for such study with as much lead time as reasonably possible. Regeneron shall consult and coordinate with KINISKSA regarding the feasibility of fulfilling said Forecast and shall make commercially reasonable efforts to fulfill said Forecast.
(c) Promptly following receipt of a Forecast, Regeneron shall notify KINIKSA of its ability to supply the requirements of the first month Forecast. In the event Regeneron notifies KINIKSA that it is able to meet such requirements, then such Forecast shall be deemed accepted by Regeneron. On the other hand, if Regeneron notifies KINIKSA that it is not able to satisfy a Forecast, then Regeneron shall prepare and provide KINIKSA with a time schedule for additional Manufacturing of each calendar quarter the Finished Product and/or placebo to satisfy the requirements of such Forecast within (10) Business Days of receipt of such Forecast, and (i) the Parties shall mutually agree upon a non-binding good faith estimate revised Forecast consistent with such time schedule, and (ii) upon such mutual agreement, such revised Forecast shall be deemed accepted by Regeneron. Regeneron shall not be obligated to supply Product or placebo under this Agreement except pursuant to a Forecast that is accepted by Regeneron in accordance with this Section 2.2.
(d) An accepted Forecast may be modified by KINIKSA to increase or decrease the number of units of Finished Product and/or placebo to be supplied on a certain delivery date under such Forecast, solely as follows:
(i) during the time period occurring more than twelve (12) months prior to such delivery date, KINIKSA may modify the number of such units without restriction, and;
(ii) during the time period occurring within twelve (12) months prior to such delivery date (“Quarterly ForecastFirm Order Commitment”), KINIKSA may not modify the number of such units, without Regeneron’s prior written consent.
(e) by quarter of Reliant’s requirements KINIKSA shall provide Regeneron with firm purchase orders for Finished Product and/or placebo at least twelve (12) months prior to the Active Ingredient for delivery dates specified in an accepted Forecast (“Firm Orders”). Each Firm Order submitted will be consistent with the calendar quarter and Firm Order Commitment. If Kiniksa fails to meet its Firm Order Commitment, then Regeneron will use reasonable efforts to reallocate the succeeding three (3) calendar quartersexcess Product. Reliant If Regeneron cannot re-allocate any such Product, then Kiniksa will be obligated to purchase 75% of such Product. If Kiniksa’s orders exceed the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approvalfirm order forecast, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall then Regeneron will use its best reasonable efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall meet those orders, but will not be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, liable if it is not able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall governdo so.
(f) Reliant Finished Product shall notify ASL have a shelf life of any shortat least twenty-shipment claims within thirty four (3024) days months (“Minimum Shelf Life”) at the time of receipt of by Kiniksa (or its designee); provided that Kiniksa acknowledges that Finished Product for the Initial Clinical Studies may not have the Minimum Shelf Life, in which case it shall have the shelf life agreed upon by the Parties at time that Kiniksa submits a shipment of Active Ingredientpurchase order for such Finished Product.
(g) ASL shall All Firm Orders for Finished Product (to the extent not already finished and on hand) must be obligated to accept any returns in multiples of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act1250 vials.
Appears in 2 contracts
Sources: Clinical Supply Agreement (Kiniksa Pharmaceuticals, Ltd.), Clinical Supply Agreement (Kiniksa Pharmaceuticals, Ltd.)
Forecasts and Purchase Orders. On or before the twelfth (a12th) Following Regulatory Approval day of one each month, beginning on January 12, 2022, Indivior shall furnish to Curia a written twelve (12) month rolling forecast of the Initial Products quantities of Product that Indivior intends to order from Curia during such period ("Rolling Forecast"). The first six (6) months of such Rolling Forecast shall constitute a firm and binding commitment to order quantities of Product specified therein ("Firm Period Forecast"), and the term following six (6) months of the Rolling Forecast shall be non-binding, good faith estimates. Each month of the Rolling Forecast shall begin on the twelfth (12th) of the calendar month in which such Rolling Forecast is submitted and end on the eleventh (11th) day of the following calendar month. With exception to the Firm Period Forecast, Curia reserves the right to reject any Rolling Forecast that does not align with the physical Processing capabilities of the Facility(ies) and the parties shall work in good faith to adjust the Rolling Forecast based on available resources, Facility capacity and other relevant factors. Indivior shall have the right to request an increase of the Firm Period Forecast to include additional units of Product. Curia may, in its sole discretion, supply such additional quantities, subject to Curia's other supply commitments and manufacturing capacity. In the event Curia agrees to supply such additional quantities, Indivior shall submit a Purchase Order for such additional quantities, with the required lead times as specified below. In no event shall Curia's inability to fulfill Purchase Orders for quantities in excess of the Firm Period Forecast be deemed a breach of this Agreement, Reliant nor relieve Indivior of its obligations under this Agreement. Indivior shall provide to ASL no later than the first day of the first month of submit with each calendar quarter Rolling Forecast, a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements cancelable Purchase Order for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order Firm Period Forecast (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding such portion of the then current Quarterly Firm Period Forecast not covered by previously submitted Purchase Orders). Indivior may alternatively submit Purchase Orders for certain portions of the Firm Period Forecast subsequent to the submission of the Rolling Forecast, provided the Purchase Orders provide the required lead time for Processing as set forth below. The Active Ingredient Curia shall notify Indivior of acceptance of the Rolling Forecast and any Purchase Order within seven (7) business days of receipt. Curia shall be shipped C.I.F. Duty Unpaid deemed to a Designated Facility or other location agreed have accepted Purchase Orders which it does not acknowledge within seven (7) business days of receipt. Curia shall have the right to reject Rolling Forecasts and Purchase Orders that are inconsistent with this Agreement. Each Purchase Order shall specify the quantity of Product being ordered, and the desired delivery date. Upon mutual agreement in writing for additional quantities of Product beyond the Firm Period Forecast, including projected delivery date(s), Indivior shall issue the applicable Purchase Order to be accepted by the partiesCuria as described above. Active Ingredient Once placed, all Purchase Orders for Product shall be shipped upon completion non-cancelable. No different or additional terms or conditions set forth in any Purchase Order shall modify in any way the terms and conditions of production this Agreement, and in temperature-controlled vehicles the event of a conflict between terms in accordance with the specifications including light protecting containers any Purchase Order and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar documentAgreement, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications control. All Purchase Orders submitted in accordance with Section 2.9(a)the terms of this Agreement shall be effective and binding on the parties upon acceptance by Curia. Except as otherwise provided herein, was not manufactured in accordance with GMPneither party shall have the right or power to refuse, reduce, or does not otherwise comply with the manufacturingmodify their obligations under any Purchase Order; however, storage and/or transportation requirements of the ActPurchase Orders may be amended (i) upon written mutual agreement regarding such modification that is signed by both parties; or (ii) as otherwise provided in this Section 4.3 or Section 4.4.
Appears in 2 contracts
Sources: Master Development and Supply Agreement (Indivior PLC), Master Development and Supply Agreement (Indivior PLC)
Forecasts and Purchase Orders. (a) Following 3.2.1 Customer shall, prior to the first filing for Regulatory Approval of one in any country of the Initial Products during the term of this Agreement, Reliant shall provide Recro Territory deliver to ASL no later than the first day of the first month of each calendar quarter Supplier a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s its initial requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial ForecastQuantities”) ). Customer may deliver to Supplier a binding Purchase Order for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASLsuch Initial Quantities, which shall be placed at least quantities Supplier shall, subject to Section 3.2.6, deliver to Customer within ninety (90) days prior of the Purchase Order date; and
3.2.2 Customer shall deliver to desired date Supplier a non-binding estimate of deliveryits quarterly requirements of API for the first year following receipt of Regulatory Approval of a Recro Product (the “First Annual Forecast”).
(c) ASL 3.2.3 On the first day of each calendar quarter following Customer’s receipt of such Regulatory Approval, Customer shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) provide its rolling estimated quarterly forecast of API for each of the Quarterly eight (8) quarters following the end of such quarter (each, a “Forecast”). The forecasted quantities shown in the Forecast for the relevant quarterfirst quarter shall be considered binding upon Customer and Customer shall be under obligation to place binding Purchase Order(s) for same. The forecasted quantities of API for any period after the first quarter shall be for the sole purpose of assisting Supplier in its planning and will not constitute an obligation of Customer to purchase the quantities of API indicated.
3.2.4 Simultaneously with the furnishing of each Forecast, ASL Customer shall deliver Purchase Orders to Supplier covering the first quarter of the Forecast. The requested delivery date shall be no less than ninety (90) days after the date of the Purchase Order. Supplier shall acknowledge receipt of each Purchase Order within five (5) business days of Supplier’s receipt thereof. Supplier shall use its best reasonable commercial efforts to supply 125deliver such quantities of API by the requested delivery date. In the event that a term or condition contained in any Purchase Order or confirmation is inconsistent with this Agreement, then the term or condition set forth in the Purchase Order or acknowledgement shall not be binding unless the Party against whom enforcement is sought expressly agrees thereto in writing.
3.2.5 Supplier covenants and agrees that Supplier’s Manufacturing capacity is and shall be adequate to meet at least 130% of Customer’s needs for Developmental Quantities and the quantity orderedForecasts.
(d) ASL 3.2.6 In the event that Customer requires quantities in excess of 130% of those set forth in any Forecast or Purchase Order, Supplier shall maintain minimum inventory levels equal use its commercially reasonable efforts to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of fulfill such request as soon as possible after receipt of a shipment of Active IngredientPurchase Order covering such additional quantities.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 2 contracts
Sources: Api Supply Agreement (Baudax Bio, Inc.), Api Supply Agreement (Recro Pharma, Inc.)
Forecasts and Purchase Orders. 2.2.1. Not later than ninety (a90) Following Regulatory Approval days following the Effective Date, Licensee shall provide GPC Biotech with a good faith, written forecast of one its anticipated requirements of the Licensed Product and proposed delivery dates thereof for the period beginning on the Effective Date and ending six (6) full Calendar Quarters thereafter (“Initial Products during the term of this Agreement, Reliant shall provide to ASL no Forecast”). Not later than thirty (30) days prior to the first day beginning of the first month full Calendar Quarter after the Initial Forecast and each subsequent full Calendar Quarter of each calendar quarter the Term, Licensee shall submit to GPC Biotech a non-binding good faith estimate faith, written forecast of its anticipated requirements of the Licensed Product and proposed delivery dates thereof for such Calendar Quarter and the five (5) Calendar Quarters thereafter (such forecasts, together with the Initial Forecast, the “Quarterly ForecastForecasts”) by quarter of Reliant’s requirements (for example, not later than thirty (30) days prior to the Active Ingredient for Calendar Quarter that begins April 1, 2007, Licensee shall submit a Forecast covering the calendar quarter and the succeeding three (3) calendar quartersperiod from April 1, 2007 through September 30, 2008). Reliant will be obligated to purchase 75% of the The quantities of API forecasted for Licensed Product and delivery dates applicable to the first two (2) succeeding calendar quarters Calendar Quarters in each Forecast shall constitute a binding obligation of each Quarterly Forecast. Within (30) days Licensee to purchase and of Regulatory Approval, Reliant GPC Biotech to supply such quantities and shall provide an initial forecast (“Initial Forecast”) for not be subject to change without the four calendar quarters following Regulatory Approvalprior written approval of both GPC Biotech and Licensee.
(b) Reliant 2.2.2. Licensee shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to Licensed Product by the parties) issuance of Purchase Orders to ASL, which shall be placed GPC Biotech at least ninety one hundred twenty (90120) days prior to the delivery date specified in each respective Purchase Order. Each Purchase Order shall designate the desired date quantities of delivery.
(cLicensed Product and the delivery date(s) ASL shall thereof, and each Purchase Order must be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to consistent with the binding portion of the then current Quarterly Forecastmost recently delivered Forecast and shall constitute a binding commitment by Licensee to order from GPC Biotech and by GPC Biotech to deliver to Licensee when placed. The Active Ingredient All Purchase Orders shall be shipped C.I.F. Duty Unpaid to a Designated Facility for Full Product Batch quantities of Licensed Product or other location agreed by the partiesintegral multiples thereof.
2.2.3. Active Ingredient GPC Biotech shall be shipped upon completion confirm acceptance of production in temperature-controlled vehicles each Purchase Order submitted in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims Section 2.2.2 within thirty (30) days of after receipt of a shipment of Active Ingredient.
(g) ASL thereof and shall not be obligated use commercially reasonable efforts to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications deliver Licensed Product against each Purchase Order in accordance with Section 2.9(a), was not manufactured in accordance with GMPthe delivery date set forth therein.
2.2.4. Each Purchase Order shall be subject to all of the terms and conditions of this Agreement. To the extent any terms or provisions of a Purchase Order or the written acceptance thereof by GPC Biotech conflict with, or does not otherwise comply with are in addition to, the manufacturingterms and provisions of this Agreement, storage and/or transportation requirements the terms and provisions of the Actthis Agreement shall control.
Appears in 2 contracts
Sources: Supply Agreement (Pharmion Corp), Supply Agreement (GPC Biotech Ag)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one Beginning on the date hereof and hereafter on or prior to the fifth day preceding each calendar month of the Initial Products during the term of this AgreementTerm, Reliant Manufacturer shall provide to ASL no later than the first day Sharp with a twelve (12) month rolling forecast (each, a "Forecast") of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s Manufacturer's quantity and delivery date requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory ApprovalPackaged Products.
(b) Reliant The first three (3) months of each Forecast shall place constitute a firm order (“Firm Order") and shall be binding upon Manufacturer (whether or not Sharp receives a Purchase Order in connection with such three month period). For the purposes of ordering Secondary Packaging Materials and scheduling capacity, Manufacturer shall provide Sharp with purchase orders (each, a "Purchase Order") in connection with such three (3) month period for Active Ingredient by written the Packaged Products to be supplied during such period, which shall specify the quantities and delivery dates for the Packaged Products for such period. Sharp shall ensure it has sufficient packaging materials necessary to package the volume of Product in the Firm Order. So long as the quantity and delivery date requirements set forth in the Purchase Orders during such three (3) month period are within a tolerance range of minus/plus ten percent (-10%/+10%) of the Firm Order (the "Tolerance Range"), Sharp shall respond with an order acknowledgment within five (5) business days. If the quantity und delivery date requirements set forth In the Purchase Orders are outside the Tolerance Range, or electronic in the event that Manufacturer desires to subsequently amend a Purchase Order, then the parties shall cooperate in good faith to develop a mutually agreeable purchase order (or by any other means agreed to by the partiesa "Revised Purchase Order") to ASL, which shall be placed at least ninety thirty (9030) days prior to desired date the scheduled start of deliveryproduction; provided, however that in the event a Revised Purchase Order is not agreed upon by the parties, both parties shall be obligated to perform in accordance with the Firm Order, within the tolerances set forth in the Tolerance Range.
(c) ASL Nothing printed or written on any Purchase Order or Sharp order acknowledgement or on any other similar form or document shall be obligated to supply Active Ingredient as ordered by Reliantmodify or expand either party's obligations under this Agreement. To In the extent purchase orders in event of any calendar month exceed One Hundred Fifty percent (150%) inconsistency between the terms of any Purchase Order or Sharp order acknowledgement, on the Quarterly Forecast for the relevant quarterone hand, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain terms of this Agreement, on the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar documenthand, the terms of this Agreement shall governprevail.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 2 contracts
Sources: Packaging and Supply Agreement (Indivior PLC), Packaging and Supply Agreement (Indivior PLC)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one 8.01 On or before October 1 during each Calendar Year of the Initial Products during the term of this AgreementTerm hereof, Reliant Purchaser shall provide to ASL no later than the first day of the first month of each calendar quarter Manufacturer a non-binding good faith annual forecast describing on a Monthly basis Purchaser's reasonably best estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for total quantity of Product Purchaser will require during the calendar quarter and following Calendar Year but not in excess of the succeeding three (3) calendar quartersAnnual Production Capacity. Reliant If Manufacturer reasonably believes it will be obligated unable to purchase 75% of supply the quantities of API forecasted for in the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approvalannual forecast, Reliant Manufacturer shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders advise Purchaser in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims writing within thirty (30) days of the date of Manufacturer's receipt of the annual forecast and the parties will discuss in good faith in an effort to agree upon mutually acceptable alternative quantities and delivery dates. Commencing on the date hereof and thereafter during the Term hereof, not later than seven (7) Working Days prior to the beginning of each Month, Purchaser shall provide Manufacturer a shipment non-binding three (3) Month forecast containing Purchaser's reasonably best estimate of Active Ingredientthe Monthly volume of Product Purchaser will require, but not in excess of the Quarterly Production Capacity. Purchase Orders of Product within the Monthly forecasted volume, but not in excess of the Monthly Production Capacity, shall be submitted in writing or electronically on a weekly basis and adjusted to reflect customer patterns, Raw Material delivery and finished goods logistics. Weekly Purchase Orders shall not exceed the Weekly Production Capacity. Purchase Orders shall specify quantity of Product to be produced and delivered and the delivery time. In no event, shall the cumulative volume per Purchase Orders from any 12 consecutive months exceed the Annual Capacity.
8.02 Purchaser will accept quantities of Product as ordered which meet the Specifications.
8.03 With respect to each delivery of Product hereunder Manufacturer shall furnish as to each Purchase Order (g) ASL which will specify the customer of Purchaser for which the Product is to be produced), the production lot identification and a certificate of analysis.
8.04 Manufacturer shall not be obligated entitled to accept any returns schedule routine shutdowns of Active Ingredient other than the P2S5 Unit from time to time so as a result to be able to perform necessary maintenance. Manufacturer will coordinate timing of such Active Ingredient failing shutdowns with Purchaser to meet limit, to the Specifications in accordance with Section 2.9(a)extent reasonably possible, was not manufactured in accordance with GMPinterruption of supply of Product and to ensure, or does not otherwise comply with the manufacturingextent reasonably possible, storage and/or transportation requirements customer orders are met.
8.05 In the event that Purchaser requests that Manufacturer increase production capacity at the P2S5 Unit above the Production Capacity, the actual capital expenditures and project expenses related to such expansion shall be borne by Purchaser as part of the ActTolling Fee. If Purchaser is not willing to bear such costs, Manufacturer shall be under no obligation to increase capacity.
Appears in 1 contract
Forecasts and Purchase Orders. AFFYMETRIX will issue a forecast schedule during the [**] covering its estimated requirements for PRODUCTS for the succeeding [**]. Such forecast will be considered for planning purposes only and not a purchase commitment. Within ten (a10) Following Regulatory Approval business days after the effective date of one this AGREEMENT, AFFYMETRIX will issue to ENZO its first forecast schedule, it being understood by the parties that the first forecast for PRODUCTS will be based upon an [**.] A purchase order will be issued by AFFYMETRIX at least [**] in advance of the Initial Products during the term requested delivery of this Agreement, Reliant shall provide to ASL no later PRODUCT. This purchase order will indicate specific delivery and/or shipping requirements. Orders placed with ENZO may not be canceled by AFFYMETRIX more than the first day [**] after issuance of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s order. ENZO will meet such delivery and/or shipping requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% unless it advises AFFYMETRIX within [**] of the quantities date of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic such purchase order (or that it is unable to supply PRODUCT as ordered by any other means AFFYMETRIX, whereupon the parties agree to discuss a revised schedule for delivery of PRODUCT to AFFYMETRIX. After ENZO and AFFYMETRIX agree to the provisions of a revised schedule, ENZO will make reasonable efforts to fulfill the provisions of the revised schedule; in no instance, however, will PRODUCT(s) be shipped [**] after issuance of the purchase order by AFFYMETRIX, unless agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the both parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing If ENZO is unable to meet the Specifications revised schedule, ENZO may designate interim or temporary manufacturers to manufacture PRODUCTS for ENZO, until such time as ENZO is ready to recommence supply by itself to AFFYMETRIX. Each purchase order shall be governed by the relevant provisions of this AGREEMENT (unless otherwise expressly provided in accordance with Section 2.9(a), was not manufactured the individual purchase order and confirmed in accordance with GMP, writing by ENZO and AFFYMETRIX) and no term or does not otherwise comply with condition which may appear in the manufacturing, storage and/or transportation requirements printed matter in an AFFYMETRIX order form or any ENZO form that is contrary to the provisions of the Actthis AGREEMENT shall be binding on either party or apply to any transaction under this AGREEMENT.
Appears in 1 contract
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one 8.01 On or before October 1 during each Calendar Year of the Initial Products during the term of this AgreementTerm hereof, Reliant Purchaser shall provide to ASL no later than the first day of the first month of each calendar quarter Manufacturer a non-binding good faith annual forecast describing on a Monthly basis Purchaser's reasonably best estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for total quantity of Product Purchaser will require during the calendar quarter and following Calendar Year but not in excess of the succeeding three (3) calendar quartersAnnual Production Capacity. Reliant If Manufacturer reasonably believes it will be obligated unable to purchase 75% of supply the quantities of API forecasted for in the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approvalannual forecast, Reliant Manufacturer shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders advise Purchaser in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims writing within thirty (30) days of the date of Manufacturer's receipt of the annual forecast and the parties will discuss in good faith in an effort to agree upon mutually acceptable alternative quantities and delivery dates. Commencing on the date hereof and thereafter during the Term hereof, not later than seven (7) Working Days prior to the beginning of each Month, Purchaser shall provide Manufacturer a shipment non-binding three (3) Month forecast containing Purchaser's reasonably best estimate of Active Ingredientthe Monthly volume of Product Purchaser will require, but not in excess of the Quarterly Production Capacity. Purchase Orders of Product within the Monthly forecasted volume, but not in excess of the Monthly Production Capacity, shall be submitted in writing or electronically on a weekly basis and adjusted to reflect customer patterns, Raw Material delivery and finished goods logistics. Weekly Purchase Orders shall not exceed the Weekly Production Capacity. Purchase Orders shall specify quantity of Product to be produced and delivered and the delivery time. In no event, shall the cumulative volume per Purchase Orders from any 12 consecutive months exceed the Annual Capacity.
8.02 Purchaser will accept quantities of Product as ordered which meet the Specifications.
8.03 With respect to each delivery of Product hereunder Manufacturer shall furnish as to each Purchase Order (g) ASL which will specify the customer of Purchaser for which the Product is to be produced), the production lot identification and a certificate of analysis. 8.04 Manufacturer shall not be obligated entitled to accept any returns schedule routine shutdowns of Active Ingredient other than the P2S5 Unit from time to time so as a result to be able to perform necessary maintenance. Manufacturer will coordinate timing of such Active Ingredient failing shutdowns with Purchaser to meet limit, to the Specifications in accordance with Section 2.9(a)extent reasonably possible, was not manufactured in accordance with GMPinterruption of supply of Product and to ensure, or does not otherwise comply with the manufacturingextent reasonably possible, storage and/or transportation requirements customer orders are met.
8.05 In the event that Purchaser requests that Manufacturer increase production capacity at the P2S5 Unit above the Production Capacity, the actual capital expenditures and project expenses related to such expansion shall be borne by Purchaser as part of the Act.Tolling Fee. If Purchaser is not willing to bear such costs, Manufacturer shall be under no obligation to increase capacity. 10 <PAGE> <PAGE> ARTICLE 9 -
Appears in 1 contract
Sources: Toll Manufacturing Agreement
Forecasts and Purchase Orders. (a) Following Regulatory Approval 5.1 Forecasts and Purchase Orders CUSTOMER and BVL shall cooperate in estimating and scheduling the MANUFACTURING of one PURCHASE ORDERS. The annual quantity contained in forecast will be divided into individual BATCH PURCHASE ORDERS evenly distributed over the course of any 12 months period, provided that the total quantities ordered by these PURCHASE ORDERS meets the requirements of Article 5. BVL and CUSTOMER may upon written mutual agreement plan production to accommodate varying monthly demand for the PRODUCT.
5.1.1 Five Year Planning Forecasts CUSTOMER will determine its good faith projected five year PRODUCT MANUFACTURE needs, and the initial forecast for each PRODUCT will be included in Attachment A for each presentation of the Initial Products during PRODUCT. The format of the term forecast will be outlined in Attachment A. The first five-year forecast will be incorporated in Attachment A for each presentation of the PRODUCT to be MANUFACTURED under this AgreementAGREEMENT. The five-year forecast will be updated at least annually by CUSTOMER, Reliant which will be due by February 28 each year. In the event the updated five-year forecast represents an increase of greater than [...***...] in any given year included in the prior year five-year forecast or [...***...] over the last year planned in the previous forecast, then the updated forecast will be subject to acceptance by BVL based on available capacity. BVL shall provide confirm its rejection of the quantities for the first two years of each annual update to ASL no later than the five year forecast which are in excess of such [...***...] increase by written notice to CUSTOMER within one hundred and eighty (180) days after receipt of CUSTOMER’s annual update to the 5 year forecast.
5.1.2 Rolling 12 Month Forecast One Hundred and Twenty (120) days in advance of the first day of the first month of each calendar quarter CUSTOMER will provide BVL with a non-binding good faith estimate (“Quarterly Forecast”12 month rolling forecast for all presentations of the PRODUCT(S) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding included in Attachment(s) A. The first three (3) months or first calendar quarters. Reliant quarter will be obligated to purchase 75% of the quantities of API forecasted considered FIRM ORDERS for the first two (2) succeeding calendar quarters of which CUSTOMER will provide PURCHASE ORDERS for each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion BATCH of production required. BATCHES are defined in temperature-controlled vehicles the PRODUCT Description incorporated in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(eAttachment(s) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.A.
Appears in 1 contract
Forecasts and Purchase Orders. 6.2.1 On the EFFECTIVE DATE, or such later date that is at least ninety (a90) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than days preceding the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliantrequested delivery date for SUPPLIED MATERIALS, FIOCRUZ shall deliver to PROTALIX, FIOCRUZ’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% quarterly projection of the quantities of API forecasted SUPPLIED MATERIALS that FIOCRUZ anticipates ordering from PROTALIX for the four (4) calendar quarters commencing with the first quarter that includes the first requested delivery date (the “INITIAL FORECAST”), together with a Purchase Order for SUPPLIED MATERIALS for the first two (2) succeeding calendar quarters of each Quarterly covered by such Initial Forecast. Within (30) days The quantities of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) SUPPLIED MATERIALS specified for the four calendar remaining quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which of such Initial Forecast shall be placed at least non-binding. Thereafter, ninety (90) days prior to desired the first business day of each subsequent calendar quarter during the Term, FIOCRUZ shall deliver to PROTALIX a rolling four (4) calendar quarter forecast updating the prior forecast (together with the Initial Forecast, each a “FORECAST”), together with a Purchase Order for the first two (2) calendar quarters of such Forecast. The quantities of SUPPLIED MATERIALS specified for the remaining two (2) quarters of such Forecast shall be non-binding. Unless agreed separately between the PARTIES, each Purchase Order shall specify no more than three (3) delivery dates for the SUPPLIED MATERIALS in each calendar quarter. Purchase Orders shall be in writing, and no verbal communications or e-mail shall be construed to mean a commitment to purchase or sell. PROTALIX shall confirm receipt of any valid Purchase Order as soon as reasonably practicable after receipt. Subject to Sections 6.2.2, PROTALIX shall provide SUPPLIED MATERIALS to FIOCRUZ pursuant to valid Purchase Orders issued by FIOCRUZ to PROTALIX. FIOCRUZ shall provide PROTALIX with a written acknowledgment of receipt of SUPPLIED MATERIALS within three (3) BUSINESS DAYS of its receipt of SUPPLIED MATERIALS. This written acknowledgment shall confirm the quantity of SUPPLIED MATERIALS delivered and the date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 1 contract
Sources: Technology Transfer and Supply Agreement (Protalix BioTherapeutics, Inc.)
Forecasts and Purchase Orders. (a) Following 3.2.1 Customer shall, prior to the first filing for Regulatory Approval of one in any country of the Initial Products during the term of this Agreement, Reliant shall provide Recro Territory deliver to ASL no later than the first day of the first month of each calendar quarter Supplier a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s its initial requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial ForecastQuantities”) ). Customer may deliver to Supplier a binding Purchase Order for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASLsuch Initial Quantities, which shall be placed at least quantities Supplier shall, subject to Section 3.2.6, deliver to Customer within ninety (90) days prior of the Purchase Order date; and
3.2.2 Customer shall deliver to desired date Supplier a non-binding estimate of deliveryits quarterly requirements of API for the first year following receipt of Regulatory Approval of a Recro Product (the “First Annual Forecast”).
(c) ASL 3.2.3 On the first day of each calendar quarter following Customer’s receipt of such Regulatory Approval, Customer shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) provide its rolling estimated quarterly forecast of API for each of the Quarterly eight (8) quarters following the end of such quarter (each, a “Forecast”). The forecasted quantities shown in the Forecast for the relevant quarterfirst quarter shall be considered binding upon Customer and Customer shall be under obligation to place binding Purchase Order(s) for same. The forecasted quantities of API for any period after the first quarter shall be for the sole purpose of assisting Supplier in its planning and will not constitute an obligation of Customer to purchase the quantities of API indicated. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.2.4 Simultaneously with the furnishing of each Forecast, ASL Customer shall deliver Purchase Orders to Supplier covering the first quarter of the Forecast. The requested delivery date shall be no less than ninety (90) days after the date of the Purchase Order. Supplier shall acknowledge receipt of each Purchase Order within five (5) business days of Supplier’s receipt thereof. Supplier shall use its best reasonable commercial efforts to supply 125deliver such quantities of API by the requested delivery date. In the event that a term or condition contained in any Purchase Order or confirmation is inconsistent with this Agreement, then the term or condition set forth in the Purchase Order or acknowledgement shall not be binding unless the Party against whom enforcement is sought expressly agrees thereto in writing.
3.2.5 Supplier covenants and agrees that Supplier’s Manufacturing capacity is and shall be adequate to meet at least 130% of Customer’s needs for Developmental Quantities and the quantity orderedForecasts.
(d) ASL 3.2.6 In the event that Customer requires quantities in excess of 130% of those set forth in any Forecast or Purchase Order, Supplier shall maintain minimum inventory levels equal use its commercially reasonable efforts to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of fulfill such request as soon as possible after receipt of a shipment of Active IngredientPurchase Order covering such additional quantities.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 1 contract
Sources: Api Supply Agreement
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products 6.1 AMERSHAM shall issue a forecast schedule during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first mid-month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s covering its estimated requirements for the Active Ingredient PRODUCTS for the calendar quarter and the succeeding three two (32) calendar quarters. Reliant Such forecast shall be considered for planning purposes only and do not represent a purchase commitment.
6.2 A purchase order will be obligated to purchase 75% issued by AMERSHAM at least sixty (60) days in advance of the quantities requested delivery date of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly ForecastPRODUCT. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic This purchase order (will indicate specific delivery and/or shipping requirements. Purchase orders will be delivered to ENZO by Federal Express or by any other means agreed to by similar carrier so that the parties) to ASL, which receipt can be confirmed. ENZO shall be placed at least ninety (90) days prior to desired meet such requirements unless it advises AMERSHAM within * of the date of delivery.
(c) ASL shall be obligated the receipt of such purchase order that it is unable to supply Active Ingredient PRODUCT as ordered by ReliantAMERSHAM whereupon the parties agree to discuss a revised schedule for delivery of PRODUCT to AMERSHAM. To After ENZO and AMERSHAM have agreed to the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) provisions of the Quarterly Forecast for the relevant quartera revised schedule, ASL shall use ENZO will make its best efforts to supply 125% fulfill the provisions of the quantity orderedrevised schedule, but if unable to do so or if agreement on a revised schedule cannot be reached, ENZO by good faith effort will designate AMERSHAM as an interim or temporary manufacturer for such PRODUCT for ENZO until such time as ENZO gives AMERSHAM written notice that ENZO is ready to recommence supply.
6.3 ENZO shall place orders for COMPONENTS within fourteen (d14) ASL shall maintain minimum inventory levels equal to the binding portion days following receipt of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the AMERSHAM's purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Actfor PRODUCTS. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement COMPONENTS shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements written specification therefor supplied by AMERSHAM with COMPONENTS. ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXCLUDED.
6.4 Each purchase order shall be governed by the relevant provisions of this AGREEMENT (unless otherwise expressly provided in the Actindividual purchase order and confirmed in writing by ENZO) and no term or condition which may appear in the printed matter in AMERSHAM's order form or any form from ENZO shall be binding on either party or apply to any transaction under this AGREEMENT.
Appears in 1 contract
Forecasts and Purchase Orders. Prior to Approval, D-NOVO will provide PLANTEX with a [*] month rolling forecast of its requirements by calendar quarter for API. Such rolling forecasts shall be delivered to PLANTEX by or on the fifteenth (a15th) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a nonduring the Term of this Agreement. Notwithstanding the foregoing, D-binding good faith estimate (“Quarterly Forecast”) by quarter of ReliantNOVO’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial [*] month forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which Approval shall be placed at least provided to PLANTEX within ninety (90) days prior to desired the anticipated date determined in good faith by D-NOVO for FDA Approval of delivery.
(c) ASL Finished Product. The first calendar quarter of each [*] month rolling forecast shall be obligated binding on PLANTEX and D-NOVO and shall constitute a firm purchase order (“Firm Purchase Order”) for the API indicated for such calendar quarter. PLANTEX shall supply D-NOVO with (i) the quantities set forth on each such Firm Purchase Order and (ii) such additional amounts that D-NOVO may order in excess of its forecasted amounts constituting Firm Purchase Orders hereunder, provided that PLANTEX shall have confirmed and accepted such additional orders within thirty (30) days of PLANTEX’s receipt of any such additional purchase order. PLANTEX agrees to supply Active Ingredient use reasonable commercial efforts to meet any such additional orders. In the event that PLANTEX determines for any reason (other than force majeure as ordered by Reliantprovided for in Section 15) to discontinue the manufacture of API, PLANTEX shall have the right to terminate its delivery obligations hereunder upon the giving to D-NOVO not less than [*] months prior written notice. To the extent The terms and conditions of this Agreement shall apply to all purchase orders issued hereunder, and, if any terms or conditions contained in such purchase orders shall conflict with any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers terms and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar documentconditions contained herein, the terms of this Agreement shall govern.
control. No additional terms or conditions set forth in any such purchase order (f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as the quantities and delivery dates set forth therein and conforming to the provisions of this Agreement) shall be binding upon PLANTEX, unless agreed to in writing by PLANTEX. Any additional terms therein contained shall be deemed to be a result proposed offer of amended terms that shall be deemed objected to by PLANTEX and of no force and effect, notwithstanding any action or inaction by PLANTEX other than its express written approval of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actadditional terms.
Appears in 1 contract
Sources: Supply Agreement (Novacea Inc)
Forecasts and Purchase Orders. 9.1 CORNERSTONE shall furnish VINTAGE, not later than sixty (a60) Following Regulatory Approval days prior to the beginning of one each calendar quarter, with updated estimates of its requirements for the following four (4) calendar quarters.
9.2 CORNERSTONE agrees to submit to VINTAGE its binding purchase orders for the Product(s) at least ten (10) weeks prior to the anticipated date of shipment of the Initial Products during Product(s) by VINTAGE. CORNERSTONE’S purchase orders shall designate the term desired quantities of Product(s) in increments of single batches for each presentation, , the delivery dates and the destination. In the event that CORNERSTONE does not require full batch sizes, CORNERSTONE shall notify VINTAGE and request that VINTAGE split the packaging of the batch between quantities set forth in two or more binding orders. VINTAGE, at its sole discretion, may decline such request. VINTAGE shall ship all orders of Product(s) in accordance with CORNERSTONE’S instructions. Should Product(s) from the remainder of a split batch Manufactured and packaged by VINTAGE to meet CORNERSTONE’S orders remain undelivered to CORNERSTONE, CORNERSTONE shall remain obligated either to purchase such remainder of the batch or pay to VINTAGE an invoice amount defined as the number of units of Product(s) that remain undelivered multiplied by the Product(s) Price, within sixty (60) days from the date of VINTAGE’S invoice, for such remainder of the batch regardless of the expiration date of such remainder.
9.3 VINTAGE agrees to make commercially reasonable efforts to fill the orders placed by CORNERSTONE for the Product(s), subject, however, to VINTAGE’S production capacities, supply of raw materials and availability of labor and transportation (all of which VINTAGE shall use commercially reasonable efforts to maintain). Accordingly, all orders for the Product(s) shall be subject to acceptance by VINTAGE, which acceptance shall not be unreasonably withheld. Should Product(s) be available, VINTAGE may ship Product(s) up to [***] days prior to a due date. [***] Confidential portions of the exhibit have been omitted and filed separately with the Securities and Exchange Commission.
9.4 VINTAGE will order all necessary raw materials and primary and secondary packaging components based on the lead time required to fill CORNERSTONE’S forecasted requirements. Subject to CORNERSTONE’S rights under Section 9.2, above, CORNERSTONE agrees to purchase from VINTAGE all Product(s) manufactured for CORNERSTONE by VINTAGE in accordance with CORNERSTONE’S purchase orders. In the event CORNERSTONE requests a change in artwork, or upon termination of this Agreement, Reliant CORNERSTONE shall provide to ASL no later than the first day purchase any inventory of Product(s) Manufactured for it by VINTAGE and remaining as of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL termination along with any components, printed labeling, packaging materials and containers, at VINTAGE’S cost, and without markup, that VINTAGE acquired and/or prepared based upon forecasts provided by CORNERSTONE pursuant to this Agreement. CORNERSTONE shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in from VINTAGE any calendar month exceed One Hundred Fifty percent (150%) inventory of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than packaging components rendered obsolete as a result of a change. In the event of any such Active Ingredient failing change or termination by VINTAGE, CORNERSTONE shall be relieved of any payment obligation it may have to meet the Specifications in accordance with Section 2.9(aVINTAGE for any inventory at VINTAGE of Product(s), was not manufactured in accordance with GMPcomponents, printed labeling, packaging materials and containers rendered obsolete because of such change or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Acttermination by VINTAGE.
Appears in 1 contract
Sources: Manufacturing Agreement (Cornerstone Therapeutics Inc)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of In order to facilitate LMI’s production planning, order management and inventory control, on *** and by the Initial Products during *** day before the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month start of each calendar quarter *** thereafter, GMS will submit to LMI a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s its Direct Product and Rx Product requirements and the Activation Device requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of its healthcare facility customers, detailing the quantities of API forecasted each Product for each Distribution Channel and Activation Devices that are required for the first two Territory for each of the following *** (2***) succeeding calendar quarters of each Quarterly Forecast. Within *** (30) days of Regulatory Approvaleach, Reliant shall provide an initial forecast (a “Initial Forecast”). All Forecasts will constitute a binding order for (i) Products from GMS only with respect to *** of the Forecast (ii) Activation Devices from GMS only with respect to *** of the Forecast, and, in the event that GMS fails to place an order (or a portion of an order) in accordance with the binding portion of the Forecast, then LMI will be entitled to treat the binding portion of the Forecast itself as a purchase order tendered for the four calendar quarters following Regulatory Approvalpotential acceptance by LMI in accordance with Section 4.1(c).
(b) Reliant shall place binding purchase For LMI’s smooth inventory and order management and so as to minimize the size and frequency of any shortfalls in meeting the *** Commitment and the applicable Minimum Purchase Requirements, GMS will (i) establish *** orders for Active Ingredient by written or electronic purchase order each Hot Product in accordance with the binding portions of its most recent Forecasts and in the quantities necessary to satisfy the *** Commitment and its Minimum Purchase Requirement with respect to that Hot Product and (or by any other means agreed ii) place *** orders for each Kit Product and Activation Devices in accordance with the binding portions of its most recent Forecasts and, as applicable, in the quantities necessary to by satisfy the parties) *** Commitment and its Minimum Purchase Requirement with respect to ASL, which shall be placed at least ninety (90) days prior to desired date of deliverythat Kit Product.
(c) ASL shall GMS will place orders for Products and Activation Devices under this Agreement in written, electronic or verbal (followed by written confirmation) form which will specify: (i) the quantity of each Product and Activation Devices being ordered, (ii) the requested shipping date and (iii) the shipping destination (which, for Hot Products, must be obligated a licensed GMS Radiopharmacy or distribution center). All orders are subject to supply Active Ingredient (1) LMI’s customary ordering requirements and lead times as ordered by Reliant. To in effect from time to time (including those described in Section 2.1(a) for Activation Devices), (2) LMI’s reasonable discretion to determine the extent purchase orders in any calendar month exceed One Hundred Fifty method of shipment (provided that GMS will have the option to find and choose a qualified, more competitive alternative, the costs for which LMI will charge on a pass-through basis, with a *** percent (150***%) markup) and (3) acceptance by LMI, which will not be unreasonably withheld (for the avoidance of doubt, LMI will not be required to accept any volumes above *** percent (***%) of the Quarterly Forecast for quantities set forth in the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly most recent Forecast). The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion terms of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and will prevail over any inconsistent terms in any purchase order, purchase order releaseacknowledgment or invoice, confirmation, acceptance and no additional terms other than those set forth in this Agreement or any similar document, allowed pursuant to the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a2.1(a), was not manufactured Section 2.3 and this Section 4.1(c) in accordance with GMPa purchase order, acknowledgement or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actinvoice will be binding on either Party.
Appears in 1 contract
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered[***].
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 1 contract
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products 6.1 AMERSHAM shall issue a forecast schedule during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first mid-month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s covering its estimated requirements for the Active Ingredient PRODUCTS for the calendar quarter and the succeeding three two (32) calendar quarters. Reliant Such forecast shall be considered for planning purposes only and do not represent a purchase commitment.
6.2 A purchase order will be obligated to purchase 75% issued by AMERSHAM at least sixty (60) days in advance of the quantities requested delivery date of API forecasted for PRODUCT. This purchase order will indicate specific delivery and/or shipping requirements. Purchase orders will be delivered to ENZO by Federal Express or similar carrier so that the first two receipt can be confirmed. ENZO shall meet such requirements unless it advises AMERSHAM within fifteen (215) succeeding calendar quarters of each Quarterly Forecast. Within (30) business days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic date of the receipt of such purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated that it is unable to supply Active Ingredient PRODUCT as ordered by ReliantAMERSHAM whereupon the parties agree to discuss a revised schedule for delivery of PRODUCT to AMERSHAM. To After ENZO and AMERSHAM have agreed to the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) provisions of the Quarterly Forecast for the relevant quartera revised schedule, ASL shall use ENZO will make its best efforts to supply 125% fulfill the provisions of the quantity orderedrevised schedule, but if unable to do so or if agreement on a revised schedule cannot be reached, ENZO by good faith effort will designate AMERSHAM as an interim or temporary manufacturer for such PRODUCT for ENZO until such time as ENZO gives AMERSHAM written notice that ENZO is ready to recommence supply.
6.3 ENZO shall place orders for COMPONENTS within fourteen (d14) ASL shall maintain minimum inventory levels equal to the binding portion days following receipt of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the AMERSHAM's purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Actfor PRODUCTS. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement COMPONENTS shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements written specification therefor supplied by AMERSHAM with COMPONENTS. ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXCLUDED.
6.4 Each purchase order shall be governed by the relevant provisions of this AGREEMENT (unless otherwise expressly provided in the Actindividual purchase order and confirmed in writing by ENZO) and no term or condition which may appear in the printed matter in AMERSHAM's order form or any form from ENZO shall be binding on either party or apply to any transaction under this AGREEMENT.
Appears in 1 contract
Forecasts and Purchase Orders. 7.1 SAGENT has supplied WORLDGEN with an initial non-binding forecast showing SAGENT’s estimated monthly requirements for Product for the twelve-month (a12-months) Following Regulatory Approval of one of period commencing on the Initial Products during anticipated Commercial Launch Date. Promptly following the term of this Agreement, Reliant shall provide to ASL no later than Commercial Launch Date and thereafter on the first day of the first month of during each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements during the term hereof, SAGENT shall deliver to WORLDGEN an updated forecast for the Active Ingredient for twelve-month (12-month) period commencing on the first day of the immediately following calendar quarter and for Product. It is understood that SAGENT before signing a supply agreement with a group purchasing organization will check with WORLDGEN as to the succeeding capacity of DOBFAR to produce such quantities in the time frame required. In addition, SAGENT shall notify WORLDGEN in writing as soon as practicable after it enters into any written agreement with a group purchasing organization with respect to the sale of the Product in the Territory. SAGENT shall place purchase orders for at least the quantity of such Product specified in the first three (3) calendar quarters. Reliant months of each forecast and the remaining nine (9) months shall be a good faith estimate; provided, however, that with respect to forecasts given by SAGENT to WORLDGEN prior to the Approval Date SAGENT will be obligated have no firm obligation to purchase 75% Product prior to the Launch Date. Notwithstanding anything in this Agreement to the contrary, DOBFAR shall guarantee manufacturing capacity and the ability to supply SAGENT CONFIDENTIAL TREATMENT [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission [***] of SAGENT’s annual forecasted quantity, and provided that SAGENT has complied with all provisions of this Section 7.1, in the event DOBFAR fails to supply such quantities, and SAGENT is required to pay inability payments to any customer of SAGENT’s, then DOBFAR shall reimburse SAGENT for all such inability payments. In the event that SAGENT’s requests for quantities of Product exceed the quantities of API forecasted provided for in the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approvalforecasts that have been submitted, Reliant DOBFAR shall provide use reasonable commercial efforts to supply such an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approvalincrease in quantity.
(b) Reliant 7.2 SAGENT shall place binding firm purchase orders with WORLDGEN for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed its requirements of Product in full Batch quantities at least ninety (90) days [***] prior to desired the requested date of delivery.
(c) ASL ; provided that, if requested by SAGENT, DOBFAR shall use commercially reasonable efforts to deliver Product at such earlier time as SAGENT reasonably requests. Each firm written purchase order, signed by SAGENT’s duly authorized representative, shall authorize DOBFAR to manufacture such quantities of the Product as are set forth therein. Each purchase order shall be obligated to supply Active Ingredient as ordered by Reliant. To deemed accepted upon receipt, and DOBFAR shall deliver Product in accordance with such purchase order; provided, however, that if the extent quantity of Product set forth in a purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of order exceeds the Quarterly Forecast most recent firm forecast for Product for the relevant quartermonth to which such purchase order relates, ASL then DOBFAR shall use its commercially reasonable best efforts to supply 125% the quantity of Product in excess of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles firm forecasted amount in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any such purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL but shall not be obligated deemed to accept any returns of Active Ingredient other than as a result of have breached this Agreement if it cannot supply such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actexcess Product.
Appears in 1 contract
Sources: Manufacturing Agreement
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one Beginning on the Effective Date and thereafter on or prior to the [**] day preceding each calendar month of the Initial Products during the term of this AgreementTerm, Reliant Manufacturer shall provide to ASL no later than the first day of the first Sharp with a [**] month of each calendar quarter rolling forecast (each, a non-binding good faith estimate (“Quarterly Forecast”) by quarter of ReliantManufacturer’s quantity and delivery date requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory ApprovalPackaged Products.
(b) Reliant The first [**] months of each Forecast shall place constitute a firm order (“Firm Order”) and shall be binding upon Manufacturer (whether or not Sharp receives a Purchase Order in connection with such [**]month period). For the purposes of ordering packaging materials and scheduling capacity, Manufacturer shall provide Sharp with purchase orders (each, a “Purchase Order”) in connection with each such [**] month Firm Order period for Active Ingredient by written the Packaged Products to be supplied during that period. Every Purchase Order shall specify the quantities and delivery dates for the Packaged Products for the applicable Firm Order period. So long as the quantity and delivery date requirements set forth in the Purchase Orders during any [**] month Firm Order period are consistent with the applicable Firm Order, Sharp shall respond with an order acknowledgment within [**]. If the quantity and delivery date requirements set forth in the Purchase Orders are not consistent with the applicable Firm Order, or electronic purchase order in the event that Manufacturer desires to subsequently amend a Purchase Order, then the parties shall cooperate in good faith to issue and substitute a mutually agreeable revised Purchase Order (or by any other means a “Revised Purchase Order”) at least [**] prior to the scheduled start of the relevant production; provided, however that in the event a Revised Purchase Order is not agreed to upon by the parties) to ASL, which Manufacturer shall be placed at least ninety (90) days prior obligated to desired date of deliverypurchase all Packaged Products arising from the applicable Firm Order.
(c) ASL Nothing printed or written on any Purchase Order, Sharp order acknowledgement or on any other similar form or document shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders modify or expand either party’s obligations under this Agreement, and any pre-printed terms and conditions contained in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quartersuch Purchase Order, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility order acknowledgement or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict such form or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL document shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actapply.
Appears in 1 contract
Sources: Packaging and Supply Agreement (Nabriva Therapeutics PLC)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one Beginning on the Effective Date and thereafter on or prior to the [***] preceding each [***] month of the Initial Products during the term of this AgreementTerm, Reliant Ascendis shall provide to ASL no later than the first day of the first Sharp with a [***] ([***]) month of each calendar quarter rolling forecast (each, a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s Ascendis’ quantity and Delivery date requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory ApprovalPackaged Products.
(b) Reliant The first [***] ([***]) months of each Forecast shall place constitute a firm order (“Firm Order”) and shall be binding upon Ascendis (whether or not Sharp receives a Purchase Order in connection with such [***] period). For the purposes of ordering packaging materials and scheduling capacity, Ascendis shall provide Sharp with purchase orders (each, a “Purchase Order”) in connection with each such [***] ([***]) month Firm Order period for Active Ingredient by written the Packaged Products to be supplied during that period. Every Purchase Order shall specify the quantities and Delivery dates for the Packaged Products for the applicable Firm Order period. So long as the quantity and Delivery date requirements set forth in the Purchase Orders during any [***] ([***]) month Firm Order period are consistent with the applicable Firm Order, Sharp shall respond with an order acknowledgment within [***] ([***]) business days. If the quantity and Delivery date requirements set forth in the Purchase Orders are not consistent with the applicable Firm Order, or electronic purchase order in the event that Ascendis desires to subsequently amend a Purchase Order, then the parties shall cooperate in good faith to issue and substitute a mutually agreeable revised Purchase Order (or by any other means agreed to by the partiesa “Revised Purchase Order”) to ASL, which shall be placed at least ninety [***] (90[***]) days prior to desired date the scheduled start of deliverythe relevant production; provided, however that Sharp, prior to the agreement on a Revised Purchase Order, shall inform Ascendis of any Price implications as per section 6.1 (a) (i); and provided also that in the event a Revised Purchase Order is not agreed upon by the parties, Ascendis shall be obligated to purchase all Packaged Products arising from the applicable Firm Order.
(c) ASL Nothing printed or written on any Purchase Order, Sharp order acknowledgement or on any other similar form or document shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders modify or expand either party’s obligations under this Agreement, and any pre-printed terms and conditions contained in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quartersuch Purchase Order, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility order acknowledgement or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict such form or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL document shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actapply.
Appears in 1 contract
Sources: Packaging and Supply Agreement (Ascendis Pharma a/S)
Forecasts and Purchase Orders. 7.1. Kamada shall provide Prothya with a [****]rolling forecast for the Product supply in Batches (a) Following Regulatory Approval “Rolling Forecast”), with the [****] of one such Rolling Forecast being binding (the “Binding Forecast”). Within [****] of receipt of the Initial Products during Rolling Forecast, the term Parties will agree on a production plan and will agree on the required Source Plasma delivery schedule.
7.2. The first Rolling Forecast shall be submitted to Prothya [****] prior to the expected Regulatory Commencement Date but shall not be binding on either Party until the Regulatory Commencement Date. The first Binding Forecast shall be effective as of the Regulatory Commencement Date. The Rolling Forecast will be subsequently updated on a [****] basis and will be provided by the [****] day of each calendar month, unless otherwise determined by ▇▇▇▇▇▇, at its sole discretion.
7.3. Kamada shall issue purchase orders for Batches in the Binding Forecast, meeting, at least, the Minimum Annual Commitment, and in a form reasonably acceptable to Prothya, which shall specify at least the following: description of the Product ordered, the quantity ordered, the then current Supply Price, and the requested Delivery date meeting the relevant lead time. Kamada shall provide Prothya with purchase orders for the Product not less than [****] prior to the required Delivery date. Prothya will make reasonable commercial efforts to accommodate expedited purchase orders. Prothya shall notify ▇▇▇▇▇▇ as soon as practicable following receipt of such request if able to accommodate such expedited purchase orders. Each expedited purchase order will be subject to an increase fee of [****] of the respective Supply Price of the Batches covered in such expedited purchase order. For clarity, such expediated fee will not apply to the extent such request for expedited delivery results from any act or omission or fault of Prothya.
7.4. All Kamada purchase orders are subject to confirmation in writing by ▇▇▇▇▇▇▇, which confirmation shall be delivered by electronic mail or courier within [****]of receipt of each purchase order (each purchase order confirmed by Prothya, a “Confirmed Purchase Order”). Failure of Prothya to respond within such [****] period shall be deemed as ▇▇▇▇▇▇▇’s acceptance of the purchase order and such purchase order shall be a Confirmed Purchase Order for the purposes hereof.
7.5. If Kamada cancels a Confirmed Purchase Order and Prothya is unable to re-assign the manufacturing slot then Kamada will pay Prothya the non-cancellable out of pocket expenses Prothya incurred with respect to such Confirmed Purchase Order which cannot reasonably be mitigated. Any Raw Materials allocated to such cancelled Confirmed Purchase Order shall be reserved by Prothya for future orders submitted by ▇▇▇▇▇▇. In any event, no cancellation fees shall apply with respect to any cancellation of a Confirmed Purchase Order except for the payments expressly set forth in this Agreement. Notwithstanding the forgoing, any Confirmed Purchase Order beyond the Minimum Annual Commitment can be cancelled by Kamada upon at least [****] written notice to ▇▇▇▇▇▇▇ in advance of scheduled Delivery date set forth in the Confirmed Purchase Order, without further obligation on the part of Kamada.
7.6. Prothya shall Deliver the Product to Kamada on the confirmed Delivery date, in accordance with the Confirmed Purchase Order. Failure to Deliver the Product on the confirmed Delivery date shall be considered a material breach of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% provisions of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant Section 6.4 above shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approvalapply.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery.
(c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 1 contract
Sources: Contract Manufacturing, Services and Supply Agreement (Kamada LTD)
Forecasts and Purchase Orders. 6.2.1 On the EFFECTIVE DATE, or such later date that is at least ninety (a90) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than days preceding the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliantrequested delivery date for SUPPLIED MATERIALS, FIOCRUZ shall deliver to PROTALIX, FIOCRUZ’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% quarterly projection of the quantities of API forecasted SUPPLIED MATERIALS that FIOCRUZ anticipates ordering from PROTALIX for the four (4) calendar quarters commencing with the first quarter that includes the first requested delivery date (the “INITIAL FORECAST”), together with a Purchase Order for SUPPLIED MATERIALS for the first two (2) succeeding calendar quarters of each Quarterly covered by such Initial Forecast. Within (30) days The quantities of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) SUPPLIED MATERIALS specified for the four calendar remaining quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which of such Initial Forecast shall be placed at least non-binding. Thereafter, ninety (90) days prior to desired the first business day of each subsequent calendar quarter during the Term, FIOCRUZ shall deliver to PROTALIX a rolling four (4) calendar quarter forecast updating the prior forecast (together with the Initial Forecast, each a “FORECAST”), together with a Purchase Order for the first two (2) calendar quarters of such Forecast. The quantities of SUPPLIED MATERIALS specified for the remaining two (2) quarters of such Forecast shall be non-binding. Unless agreed separately between the PARTIES, each Purchase Order shall specify no more than three (3) delivery dates for the SUPPLIED MATERIALS in each calendar quarter. Purchase Orders shall be in writing, and no verbal communications or e-mail shall be construed to mean a commitment to purchase or sell. PROTALIX shall confirm receipt of any valid Purchase Order as soon as reasonably practicable after receipt. Subject to Sections 6.2.2, PROTALIX shall provide SUPPLIED MATERIALS to FIOCRUZ pursuant to valid Purchase Orders issued by FIOCRUZ to PROTALIX. FIOCRUZ shall provide PROTALIX with a written acknowledgment of receipt of SUPPLIED MATERIALS within three (3) BUSINESS DAYS of its receipt of SUPPLIED MATERIALS. This written acknowledgment shall confirm the quantity of SUPPLIED MATERIALS delivered and the date of delivery.
(c) ASL 6.2.2 Unless otherwise agreed in writing by PROTALIX, in no event shall PROTALIX be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders deliver quantities of SUPPLIED MATERIALS specified in any calendar month a Purchase Order for a quarter which exceed One Hundred Fifty percent (150%) [***] of the Quarterly Forecast quantities specified by FIOCRUZ for the relevant same period in the Forecast delivered in the prior calendar quarter. PROTALIX shall, ASL shall however, use its best efforts commercially reasonable efforts, but will be under no obligation, to supply 125% SUPPLIED MATERIALS in excess of [***] of such quantities specified in such Forecast. Without limitation to the quantity orderedforegoing, in no event shall PROTALIX be required to supply quantities of SUPPLIED MATERIALS in excess of those commercially reasonable for PROTALIX to supply for any given period.
(d) ASL 6.2.3 Subject to Section 6.2.2, FIOCRUZ shall maintain minimum inventory levels equal purchase all SUPPLIED MATERIALS ordered and specified in a Purchase Order. Purchase Orders may be delivered electronically or by other means to such location and in such manner as the binding portion of the then current Quarterly Forecast. The Active Ingredient PARTIES shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputableagree All Purchase Orders, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days confirmations of receipt of a shipment of Active Ingredient.
(g) ASL Purchase Orders and other notices contemplated under this Section 6.2 shall not be obligated sent to accept any returns of Active Ingredient other than as a result the attention of such Active Ingredient failing persons as each party may identify to meet the Specifications other in writing from time to time in accordance with Section 2.9(a20.9.
6.2.4 The Forecasts shall show demand for SUPPLIED MATERIALS on a monthly basis, and for the first three months of any such Forecast shall state the dates of required delivery for such SUPPLIED MATERIAL.
6.2.5 All Forecasts and Purchase Orders shall set forth the presentation of such SUPPLIED MATERIALS (e.g., FINISHED PACKAGED PRODUCT, NAKED VIALS, BULK PRODUCT).
6.2.6 FIOCRUZ shall not submit Purchase Orders for, was and PROTALIX shall not manufactured be required to supply, any single delivery of SUPPLIED MATERIALS of less than [***] of SUPPLIED MATERIALS (or the equivalent thereof with respect to DRUG SUBSTANCE). For the avoidance of doubt, all vials supplied hereunder shall be [***].
6.2.7 PROTALIX shall use commercially reasonable efforts to meet FIOCRUZ requests for additional quantities beyond those set forth in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the ActPurchase Orders.
Appears in 1 contract
Sources: Technology Transfer and Supply Agreement (Protalix BioTherapeutics, Inc.)
Forecasts and Purchase Orders. (a) Following Regulatory Approval of one of the Initial Products during the term of this AgreementZogenix shall deliver to Supplier a good faith, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a written, non-binding good faith estimate (“Quarterly Forecast”) by quarter forecast, of Reliant’s its expected commercial requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly ForecastProduct as follows:
4.1.1. Within thirty (30) days of Regulatory Approvalthe Effective Date, Reliant a non-binding forecast that covers a twenty-four (24) month period broken down on a quarterly basis, for the period beginning with the date on which the First Approval is anticipated;
4.1.2. At least thirty (30) days before anticipated receipt of a First Approval and then on or before the last working day of each calendar month during the Term, Zogenix shall provide an initial to Supplier a rolling twenty-four (24) month forecast of its requirements for Product (“Initial Forecast”), broken down on a monthly basis with the first three (3) months of each such forecast constituting a binding commitment upon Zogenix to purchase such quantities (“Firm Period Forecast”) for the four calendar quarters following Regulatory Approvalas evidenced by Purchase Orders submitted in accordance with Section 4.1.3.
(b) Reliant shall place binding purchase 4.1.3. All firm orders for Active Ingredient by written or electronic purchase order Product (or by any other means agreed to by the parties“Purchase Order”) to ASL, shall specify: (i) the type of Product being ordered; (ii) the amount of such Product being ordered (which shall be placed in whole Batch size quantities); and (iii) the Purchase Order Delivery Date. Each Purchase Order shall be submitted to Supplier at least ninety (90) days prior to desired date of delivery.
(c) ASL before the Purchase Order Delivery Date, and shall be obligated deemed to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) be automatically accepted unless Supplier notifies Zogenix of its rejection of the Quarterly Forecast for same within five (5) Business Days of receipt, (or in the relevant quartercase of any Purchase Orders with quantities in excess of those in the most recent applicable Firm Period Forecast, ASL within ten (10) Business Days of receipt) provided that Supplier shall use its best efforts to supply 125% not reject Purchase Orders that are in compliance with this Section 4.1.3 and do not specify an amount of Product that is in excess of the quantity ordered.
most recent applicable Firm Period Forecast. Once accepted (dor deemed to be accepted) ASL shall maintain minimum inventory levels equal to by Supplier, Purchase Orders are firm and may not be cancelled or modified without the binding portion consent of the then current Quarterly Forecastother Party. The Active Ingredient shall Supplier may reject a Purchase Order Delivery Date and offer another Purchase Order Delivery Date but the new Purchase Order Delivery Date cannot be shipped C.I.F. Duty Unpaid to more than seven (7) Business Days later or ten (10) Business Days earlier than original Purchase Order Delivery Date. If there is a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specificationsnew Zogenix accepted Purchase Order Delivery Date, the Process Description and was manufactured in accordance with GMP and all other requirements of Forecast will be updated to reflect the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall governnew agreed upon date.
(f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.
Appears in 1 contract
Sources: Supply Agreement (Zogenix, Inc.)
Forecasts and Purchase Orders. Prior to Approval, D-NOVO will provide PLANTEX with a [*] month rolling forecast of its requirements by calendar quarter for API. Such rolling forecasts shall be delivered to PLANTEX by or on the fifteenth (a15th) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a nonduring the Term of this Agreement. Notwithstanding the foregoing, D-binding good faith estimate (“Quarterly Forecast”) by quarter of ReliantNOVO’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial [*]month forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval.
(b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which Approval shall be placed at least provided to PLANTEX within ninety (90) days prior to desired the anticipated date determined in good faith by D-NOVO for FDA Approval of delivery.
(c) ASL Finished Product. The first calendar quarter of each [*] month rolling forecast shall be obligated binding on PLANTEX and D-NOVO and shall constitute a firm purchase order (“Firm Purchase Order”) for the API indicated for such calendar quarter. PLANTEX shall supply D-NOVO with (i) the quantities set forth on each such Firm Purchase Order and (ii) such additional amounts that D-NOVO may order in excess of its forecasted amounts constituting Firm Purchase Orders hereunder, provided that PLANTEX shall have confirmed and accepted such additional orders within thirty (30) days of PLANTEX’s receipt of any such additional purchase order. PLANTEX agrees to supply Active Ingredient use reasonable commercial efforts to meet any such additional orders. In the event that PLANTEX determines for any reason (other than force majeure as ordered by Reliantprovided for in Section 15) to discontinue the manufacture of API, PLANTEX shall have the right to terminate its delivery obligations hereunder upon the giving to D-NOVO not less than [*] months prior written notice. To the extent The terms and conditions of this Agreement shall apply to all purchase orders issued hereunder, and, if any terms or conditions contained in such purchase orders shall conflict with any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered.
(d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers terms and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility.
(e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar documentconditions contained herein, the terms of this Agreement shall govern.
control. No additional terms or conditions set forth in any such purchase order (f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient.
(g) ASL shall not be obligated to accept any returns of Active Ingredient other than as the quantities and delivery dates set forth therein and conforming to the provisions of this Agreement) shall be binding upon PLANTEX, unless agreed to in writing by PLANTEX. Any additional terms therein contained shall be deemed to be a result proposed offer of amended terms that shall be deemed objected to by PLANTEX and of no force and effect, notwithstanding any action or inaction by PLANTEX other than its express written approval of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Actadditional terms.
Appears in 1 contract
Sources: Supply Agreement (Novacea Inc)