Forecasts and Orders. Forecasts: 4.1 GENTIUM shall provide SIRTON with a written forecast of its Product requirements for the following 12 (twelve) months (the “Forecast”), and SIRTON shall plan all its activities in relation to Manufacturing of the products against said forecast. Said Forecasts shall contain the requirements in terms of number of pieces per month. SIRTON shall provide GENTIUM with a written reply within 10 (ten) days of receipt of said Forecast, informing GENTIUM of the overall feasibility of the same. If, within 10 (ten) days, GENTIUM does not receive any response from SIRTON regarding the Forecast, feasibility of the latter shall be deemed confirmed by SIRTON. 4.2 The quantity of Products required for the first 3 (three) months of the Forecast shall constitute a confirmed order. The remaining 9 (nine) months of the Forecast shall not be deemed binding on either SIRTON or GENTIUM. 4.3 GENTIUM shall notify SIRTON, as soon as possible, of anything that could alter the Forecasts it had provided. 4.4 While everything governing SIRTON’s responsibility still holds, the latter shall immediately notify GENTIUM of anything it becomes aware of that could hinder feasibility of the Forecasts. 4.5 SIRTON is responsible for storing the Components (with the exception of the Active Principle). It ensues that GENTIUM shall pay exclusively for the Components purchased according to the confirmed orders and the forecasts for the first 3 months. 4.6 GENTIUM shall send SIRTON a purchase order for Products at least three (3) months prior to the date of delivery for said order. 4.7 SIRTON shall send GENTIUM a written order confirmation confirming the quantities and delivery date indicated in the purchase order within 10 (ten) days of receipt thereof. Once confirmed, the order shall be deemed binding for SIRTON. If GENTIUM does not receive any response from SIRTON within 10 (ten) days, the order shall be deemed confirmed. 4.8 SIRTON shall meet the delivery date indicated on the corresponding purchase order. Upon thirty (30) days prior notice, SIRTON shall guarantee the availability of an addition-extra batch above and beyond the amount for the order confirmed. 4.9 For the entire duration of the present Contract, SIRTON shall have on hand an adequate stock of Components able to fill the orders confirmed as indicated in Paragraph 4.8 and adequate for an additional production batch as reported in Paragraph 4.8. 4.10 If the variation in the packaging materials is required due to changes in the reference standards or decided at the discretion of GENTIUM, the latter shall bear any additional costs. Nevertheless, GENTIUM shall not bear the costs for the packaging materials if they do not comply with the specifications defined and forwarded by GENTIUM as indicated in Paragraph 6.4. 4.11 In the case in which (i) SIRTON does not deliver the Products at the deadline indicated in the purchase order, and (ii) if SIRTON itself is responsible for said delay, SIRTON shall pay GENTIUM, as penalty, the following sums: (a) If the delay falls between 1 (one) and 2 (two) weeks, a sum equal to 5.00% of the amount due it from GENTIUM as outlined in Attachment 2; (b) If the delay exceeds 2 (due) weeks, a sum equal to 10.00% of the amount due it from GENTIUM as outlined in Attachment 2. In both the above cases, it remains understood that the amount to be paid by SIRTON as penalty shall be automatically compensated and detracted from the amount due to be paid by GENTIUM in compliance with Article 5 below. 4.12 SIRTON shall guarantee that the number of Products per Active Principle meets the minimum quantities that can be obtained, for concentrates and standard batches, as better defined in the Technical Agreement. If the minimum quantities are not met, SIRTON shall reimburse GENTIUM the costs for production of the extra Active Principle used, as determined according to what is indicated in Attachment 2.
Appears in 1 contract
Forecasts and Orders. Forecasts:
4.1 GENTIUM shall provide SIRTON with 2.2.1 As of the Execution Date of this Agreement, a written provisional non-binding forecast of the monthly quantity of DHA Martek Product and ▇▇▇ ▇▇▇▇▇▇ Product which PURCHASER will order on behalf of itself and its Product requirements Affiliates for delivery hereunder for the following 12 (twelve) months (period from the “Forecast”)Execution Date until March 31, and SIRTON shall plan all its activities in relation to Manufacturing of the products against said forecast. Said Forecasts shall contain the requirements in terms of number of pieces per month. SIRTON shall provide GENTIUM with a written reply within 10 (ten) days of receipt of said Forecast, informing GENTIUM of the overall feasibility of the same. If, within 10 (ten) days, GENTIUM does not receive any response from SIRTON regarding the Forecast, feasibility of the latter 2009 shall be deemed confirmed established using the average monthly quantities of DHA Martek Product and ▇▇▇ ▇▇▇▇▇▇ Product ordered by SIRTON.
4.2 The quantity of Products required for PURCHASER in the first 3 six (three6) months of the Forecast shall constitute a confirmed order. The remaining 9 (nine) months of the Forecast shall not be deemed binding on either SIRTON or GENTIUM.
4.3 GENTIUM shall notify SIRTON, as soon as possible, of anything that could alter the Forecasts it had provided.
4.4 While everything governing SIRTON’s responsibility still holds, the latter shall immediately notify GENTIUM of anything it becomes aware of that could hinder feasibility of the Forecasts.
4.5 SIRTON is responsible for storing the Components (with the exception of the Active Principle). It ensues that GENTIUM shall pay exclusively for the Components purchased according to the confirmed orders and the forecasts for the first 3 months.
4.6 GENTIUM shall send SIRTON a purchase order for Products at least three (3) calendar months prior to the Execution Date (the “Initial Forecast). Thereafter, not later than December 1 and June 1 of each calendar year during the Term of this Agreement, PURCHASER shall submit to SELLER a non-binding forecast of the quantity and expected delivery dates of DHA Martek Product and ▇▇▇ ▇▇▇▇▇▇ Product that PURCHASER estimates in good faith that it will order on behalf of itself and its Affiliates for delivery under this Agreement during the four (4) quarters commencing on the immediately succeeding January 1 and July 1, respectively (each such forecast, a “Rolling Forecast”). The Initial Forecast and the Rolling Forecasts will be good-faith, best estimates of requirements and shall not be considered a firm commitment. * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
2.2.2 Except for Purchase Orders submitted by PURCHASER but not fulfilled as of the Execution Date, purchase orders (each a “Purchase Order”) for each order of DHA Martek Product and ▇▇▇ ▇▇▇▇▇▇ Product shall be placed by PURCHASER to SELLER at least sixty (60) days but no more than one hundred twenty (120) days prior to the required date of delivery of such Martek Product to PURCHASER. Each Purchase Order shall specify the shipping destination (which shall be in the Territory), and required delivery date, for said orderthe Martek Product ordered therein. SELLER shall accept each Purchase Order from PURCHASER placed in accordance with this Section 2.2.2 for up to * of the relevant volumes specified for the applicable month in the Initial Forecast or, if a Rolling Forecast has been provided, the most recent Rolling Forecast provided by PURCHASER as of the time of the placement of such Purchase Order. SELLER shall acknowledge all Purchase Orders submitted in accordance with Section 2.2.2 within ten (10) business days of SELLER’s receipt of such Purchase Orders. Purchase Orders submitted by PURCHASER in accordance with this Agreement which have been acknowledged in writing by SELLER shall be considered as firm and binding orders (subject to the terms of this Agreement) and shall only be canceled or amended by mutual written agreement of the Parties. For the avoidance of doubt, SELLER shall not reject any Purchase Order submitted by PURCHASER in accordance with Section 2.2.2.
4.7 SIRTON 2.2.3 SELLER shall send GENTIUM fulfill by the required delivery date set forth therein each Purchase Order acknowledged pursuant to Section 2.2.2; provided that SELLER shall have no liability for any breach of this Section 2.2.3 unless and until SELLER fails to deliver in accordance with Section 2.4 *as relevant, ordered by PURCHASER for delivery *for a particular shipping destination (which aggregate amount for such location for * by * In the event that SELLER fails to fulfill any Purchase Order acknowledged pursuant to Section 2.2.2 by the required delivery date, PURCHASER shall provide notice thereof to SELLER and shall use reasonable efforts to do so within *; provided, however, that any failure by PURCHASER to provide such notice within such time period shall not be a breach of this Agreement or operate or be deemed to limit any remedies available to PURCHASER hereunder.
2.2.4 Purchase Orders for amounts in addition to * of the relevant volumes specified for the applicable calendar month in the Initial Forecast or the most recent Rolling Forecast, as applicable, shall be accepted and fulfilled by SELLER as is commercially reasonable.
2.2.5 In the event of any conflict between the provisions of this Agreement and any Purchase Order, acknowledgement or invoice, or any additional terms included in any Purchase Order, acknowledgement or invoice, the provisions of this Agreement shall control. All preprinted terms and conditions contained on any Purchase Order, acknowledgement or invoice, or similar document, shall be disregarded. * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission.
2.2.6 In the event that SELLER, at any time during the Term, shall have reason to believe that it will be unable to supply PURCHASER with its requirements of Martek Products, SELLER shall use reasonable efforts to communicate with PURCHASER in a timely manner so as to help PURCHASER ensure there is no interruption in supply to PURCHASER, and the Parties shall thereafter discuss how such shortfall will be resolved. SELLER shall * provide a written order confirmation confirming the quantities and delivery date indicated in the purchase order within 10 notice to PURCHASER (ten) days of receipt thereof. Once confirmed, the order shall be deemed binding for SIRTON. If GENTIUM does not receive any response from SIRTON within 10 (ten) days, the order shall be deemed confirmed.
4.8 SIRTON shall meet the delivery date indicated on the corresponding purchase order. Upon thirty (30) days prior notice, SIRTON shall guarantee the availability of an addition-extra batch above and beyond the amount for the order confirmed.
4.9 For the entire duration of the present Contract, SIRTON shall have on hand an adequate stock of Components able to fill the orders confirmed as indicated in Paragraph 4.8 and adequate for an additional production batch as reported in Paragraph 4.8.
4.10 If the variation in the packaging materials is required due to changes in the reference standards or decided at the discretion of GENTIUM, the latter shall bear any additional costs. Nevertheless, GENTIUM shall not bear the costs for the packaging materials if they do not comply with the specifications defined and forwarded by GENTIUM as indicated in Paragraph 6.4.
4.11 In the case in which (i) SIRTON does not deliver the Products at the deadline indicated in the purchase order, and (iia “Shortfall Notice”) if SIRTON itself is responsible for said delay, SIRTON shall pay GENTIUM, as penalty, the following sums:
(a) If the delay falls between 1 (one) and 2 (two) weeks, a sum equal SELLER will be unable to 5.00% of supply PURCHASER with the amount due it from GENTIUM as outlined ordered by PURCHASER in Attachment 2;
a Purchase Order by the required delivery date set forth therein (whether by reason of a force majeure event or otherwise), or (b) If SELLER concludes that it will be unable to supply PURCHASER *set forth in the delay exceeds 2 Initial Forecast or a Rolling Forecast, as relevant, for any period for which Purchase Orders may still be placed (duei.e., more than sixty (60) weeks, days ahead) (whether by reason of a sum equal force majeure event or otherwise). Any such Shortfall Notice shall expressly identify itself as a Shortfall Notice and shall include*. Any notices pursuant to 10.00% of the amount due it from GENTIUM as outlined in Attachment 2. In both the above cases, it remains understood that the amount to be paid by SIRTON as penalty this Section 2.2.6 shall be automatically compensated for information purposes only and detracted from the amount due shall not, by themselves, be used to be paid by GENTIUM in compliance with Article 5 belowclaim a breach of this Agreement.
4.12 SIRTON shall guarantee that the number of Products per Active Principle meets the minimum quantities that can be obtained, for concentrates and standard batches, as better defined in the Technical Agreement. If the minimum quantities are not met, SIRTON shall reimburse GENTIUM the costs for production of the extra Active Principle used, as determined according to what is indicated in Attachment 2.
Appears in 1 contract
Forecasts and Orders. Forecasts:
4.1 GENTIUM shall provide SIRTON (a) Buyer has provided Sellers with a written non-binding forecast of its Product requirements purchases of Products for the following 12 Term within the Territory, said forecast being attached hereto as EXHIBIT B.
(twelveb) months Within ten (the “Forecast”), and SIRTON shall plan all its activities in relation to Manufacturing 10) business days of the products against said forecast. Said Forecasts Effective Date, Buyer shall contain update the requirements forecast described in terms of number of pieces per month. SIRTON shall provide GENTIUM with a written reply within 10 Paragraph 4.1
(tena) days of receipt of said Forecast, informing GENTIUM of the overall feasibility of the same. If, within 10 (ten) days, GENTIUM does not receive any response from SIRTON regarding the Forecast, feasibility of the latter Such amended forecast shall be deemed confirmed a non-binding (except as provided in Paragraph 14.1(c)) forecast of their purchases of Products for the Term within the Territory ("Annual Forecast"). Each Product is to be identified in such Annual Forecast by SIRTONindividual SKU.
4.2 The quantity of Products required for the first 3 (threea) months of the Forecast shall constitute a confirmed order. The remaining 9 (nine) months of the Forecast shall not be deemed binding on either SIRTON or GENTIUM.
4.3 GENTIUM shall notify SIRTON, as soon as possible, of anything that could alter the Forecasts it had provided.
4.4 While everything governing SIRTON’s responsibility still holds, the latter shall immediately notify GENTIUM of anything it becomes aware of that could hinder feasibility of the Forecasts.
4.5 SIRTON is responsible for storing the Components (with the exception of the Active Principle). It ensues that GENTIUM shall pay exclusively for the Components purchased according to the confirmed orders and the forecasts for the first 3 months.
4.6 GENTIUM shall send SIRTON a purchase order for Products at least three (3) months prior to the date of delivery for said order.
4.7 SIRTON shall send GENTIUM a written order confirmation confirming the quantities and delivery date indicated in the purchase order within 10 (ten) days of receipt thereof. Once confirmed, the order shall be deemed binding for SIRTON. If GENTIUM does not receive any response from SIRTON within 10 (ten) days, the order shall be deemed confirmed.
4.8 SIRTON shall meet the delivery date indicated on the corresponding purchase order. Upon Every thirty (30) days prior noticeduring the term hereof, SIRTON Buyer shall guarantee provide Sellers with a good faith, non-binding forecast of its purchases of Products during the availability of an addition-extra batch above next three (3) month period. Such forecasts shall be made recognizing the requirements for Batch Sizes and beyond the amount for the order confirmedLead Times as defined in Paragraph 4.2(b) hereof.
4.9 For (b) Sellers have presented Buyers with, and Buyers acknowledge the entire duration receipt of, a document listing the Products, the batch size used in the production of each such Product ("Batch Size"), and the lead times required to manufacture each of said Products ("Lead Times"), such document being appended hereto as EXHIBIT D.
(a) Buyers shall authorize the manufacture and packaging of a Product by issuing a purchase order ("Purchase Order") to Sellers and Sellers shall fill such Purchase Orders (on a FIFO basis) from Sellers' stocks of Current Product existing as 42 of the present ContractEffective Date ("Stocks") or as necessary, SIRTON Sellers shall manufacture and package, or have on hand an adequate stock packaged, such Products. Each Purchase Order shall be in a form and contain terms previously agreed to by the parties. Each Purchase Order shall correspond to a total quantity of Components able to fill Product which is a whole number multiple of the orders confirmed applicable Batch Size as indicated set forth in Paragraph 4.8 and adequate for an additional production batch as reported in Paragraph 4.8.
4.10 If the variation EXHIBIT D. The proposed delivery date recited in the packaging materials is required due Purchase Order shall also be equal to changes or greater than the applicable Lead Time for each such Product as set forth in EXHIBIT D. Each Purchase Order shall further specify the reference standards or decided at the discretion of GENTIUM, the latter shall bear any additional costs. Nevertheless, GENTIUM shall not bear the costs for the packaging materials if they do not comply with the specifications defined and forwarded by GENTIUM as indicated in Paragraph 6.4.
4.11 In the case in which following: (i) SIRTON does not deliver the Products at the deadline indicated in the purchase orderidentity of Product by SKU, and (ii) if SIRTON itself is responsible for said delay, SIRTON shall pay GENTIUM, as penalty, the following sums:
(a) If the delay falls between 1 (one) and 2 (two) weeks, a sum equal to 5.00% quantity of the amount due it from GENTIUM as outlined in Attachment 2;such Product.
(b) If Sellers shall promptly acknowledge each Purchase Order by signing and returning to Buyers the delay exceeds 2 (due) weeks, a sum equal to 10.00% acknowledgment copy of each Purchase Order promptly after its receipt. Failure of the amount due it from GENTIUM as outlined in Attachment 2. Sellers to deliver to Buyers a written notice objecting to a Purchase Order within five (5) business days after receipt of the Purchase Order shall constitute Sellers' acceptance of the Purchase Order.
(c) In both the above casesevent of any conflict between the terms and conditions of this Agreement and the terms and conditions of Buyer's Purchase Order, it remains understood that the amount to be paid by SIRTON as penalty terms and conditions of this Agreement shall be automatically compensated and detracted from the amount due to be paid by GENTIUM in compliance with Article 5 belowcontrolling.
4.12 SIRTON 4.4 Buyers may request Seller to accept an increase in Buyers' Annual Forecast of Product(s). Sellers' obligation with respect thereto shall guarantee that the solely be to exercise commercially reasonable efforts to accommodate Buyers' request so long as (a) such increase represents a whole number of Products per Active Principle meets the minimum quantities that can be obtained, for concentrates and standard batches, as better defined in the Technical Agreement. If the minimum quantities are not met, SIRTON shall reimburse GENTIUM the costs for production multiple of the extra Active Principle usedBatch Size of each such Product, as determined according to what (b) the period until the proposed date(s) of delivery is indicated in Attachment 2greater than the applicable Lead Time for each such Product, (c) the proposed date(s) of delivery is within the Term, and (d) the proposed increase does not represent more than fifty percent (50%) of the Annual Forecast of such Product.
Appears in 1 contract
Forecasts and Orders. Forecasts:
4.1 GENTIUM 5.1 Neurex will keep Mallinckrodt reasonably informed of the regulatory development of SNX-111 including the status of clinical trials and filing of the NDA with the FDA so that Mallinckrodt may anticipate when to prepare for commercial production of an FDA approved SNX- 111. Mallinckrodt shall keep all such information confidential. At the beginning of the Calendar Half-Year starting on April 1, 1997, and at the beginning of each Calendar Half-Year thereafter during the term of this Agreement, Neurex will provide SIRTON Mallinckrodt with a written twelve (12) month rolling forecast of its the quantities of Product requirements for the following 12 (twelve) months (the “Forecast”), and SIRTON shall plan all its activities in relation that Neurex expects to Manufacturing purchase during each of the products against said forecastnext twelve (12) months. Said Forecasts shall contain the requirements in terms of number of pieces per month. SIRTON shall provide GENTIUM with a written reply within 10 The first six (ten) days of receipt of said Forecast, informing GENTIUM of the overall feasibility of the same. If, within 10 (ten) days, GENTIUM does not receive any response from SIRTON regarding the Forecast, feasibility of the latter shall be deemed confirmed by SIRTON.
4.2 The quantity of Products required for the first 3 (three6) months of the Forecast each forecast shall constitute a confirmed order. The remaining 9 (nine) months of the Forecast shall not be deemed binding on either SIRTON or GENTIUM.
4.3 GENTIUM shall notify SIRTONfirm orders deliverable as provided in Section 5.2, as soon as possible, of anything that could alter the Forecasts it had provided.
4.4 While everything governing SIRTON’s responsibility still holds, the latter shall immediately notify GENTIUM of anything it becomes aware of that could hinder feasibility of the Forecasts.
4.5 SIRTON is responsible for storing the Components (with the exception of the Active Principle). It ensues that GENTIUM shall pay exclusively except for the Components purchased according period October 1, 1998 to December 31, 1998 for which the confirmed orders and the forecasts for the first 3 months.
4.6 GENTIUM shall send SIRTON a purchase order for Products at least period will be three (3) months. The balance of each twelve month forecast given by Neurex pursuant to this Section 5.1 is not a firm commitment on the part of Neurex to order the quantities of the Product set forth therein, but are given so that Mallinckrodt will have aufficient information upon which to schedule its manufacturing operations so as to be able to meet Neurex's firm orders for the Product that may be placed pursuant to Section 5.2.
5.2 At the beginning of each Calendar Half-Year, Neurex shall submit the six (6) month firm orders in writing for the quantity of the Product desired by Neurex at least six (6) months prior to the date delivery date, except for the period October 1, 1998 to December 31, 1998 for which the order period will be three (3) months, and Mallinckrodt shall supply such quantities of delivery for said orderthe Product in accordance with Schedule D attached hereto and made a part hereof.
4.7 SIRTON 5.3 Mallinckrodt shall send GENTIUM ship the Product in a written order confirmation confirming the quantities container closure system described in Schedule E attached hereto and made a part hereof at Neurex's expense in accordance with Neurex's instructions, FOB Mallinckrodt's plant. For purposes of this Agreement, delivery date indicated in the purchase order within 10 (ten) days of receipt thereof. Once confirmed, the order Product by Mallinckrodt to Neurex shall be deemed binding for SIRTON. If GENTIUM does not receive any response from SIRTON within 10 (ten) days, the order shall be deemed confirmedto have taken place upon acceptance of delivery by a Neurex-designated carrier at Mallinckrodt's plant.
4.8 SIRTON 5.4 Title to all finished Product shall meet the delivery date indicated pass to Neurex on the corresponding purchase order. Upon thirty (30) days prior notice, SIRTON shall guarantee the availability of an addition-extra batch above and beyond the amount for the order confirmeddelivery.
4.9 For the entire duration of the present Contract, SIRTON shall have on hand an adequate stock of Components able to fill the orders confirmed as indicated in Paragraph 4.8 and adequate for an additional production batch as reported in Paragraph 4.8.
4.10 If the variation in the packaging materials is required due to changes in the reference standards or decided at the discretion of GENTIUM, the latter shall bear any additional costs. Nevertheless, GENTIUM shall not bear the costs for the packaging materials if they do not comply with the specifications defined and forwarded by GENTIUM as indicated in Paragraph 6.4.
4.11 In the case in which (i) SIRTON does not deliver the Products at the deadline indicated in the purchase order, and (ii) if SIRTON itself is responsible for said delay, SIRTON shall pay GENTIUM, as penalty, the following sums:
(a) If the delay falls between 1 (one) and 2 (two) weeks, a sum equal to 5.00% of the amount due it from GENTIUM as outlined in Attachment 2;
(b) If the delay exceeds 2 (due) weeks, a sum equal to 10.00% of the amount due it from GENTIUM as outlined in Attachment 2. In both the above cases, it remains understood that the amount to be paid by SIRTON as penalty shall be automatically compensated and detracted from the amount due to be paid by GENTIUM in compliance with Article 5 below.
4.12 SIRTON shall guarantee that the number of Products per Active Principle meets the minimum quantities that can be obtained, for concentrates and standard batches, as better defined in the Technical Agreement. If the minimum quantities are not met, SIRTON shall reimburse GENTIUM the costs for production of the extra Active Principle used, as determined according to what is indicated in Attachment 2.
Appears in 1 contract
Forecasts and Orders. Forecasts:
4.1 GENTIUM 3.1 No later than 180 days prior to the Manufacturing Commencement Date, NCH shall provide SIRTON with to Supplier a written forecast of its Product requirements for the following 12 quantities of Licensed Products that NCH anticipates ordering from Supplier during the twelve (twelve12) months (month period commencing on the “Forecast”)Manufacturing Commencement Date, and SIRTON thereafter, in order to assist Supplier in planning production, NCH shall plan all its activities in relation to Manufacturing update such forecast with a twelve (12) month rolling forecast of the products against said forecast. Said Forecasts shall contain the requirements in terms quantities of number of pieces per Licensed Products required by NCH, by month. SIRTON It is understood that such forecasts are intended to be estimates only, and shall provide GENTIUM with a written reply within 10 (ten) days of receipt of said Forecastnot be binding upon NCH. Notwithstanding the foregoing, informing GENTIUM of the overall feasibility of the same. If, within 10 (ten) days, GENTIUM does not receive any response from SIRTON regarding the Forecast, feasibility of the latter NCH shall be deemed confirmed by SIRTON.
4.2 The quantity bound to purchase from Supplier one hundred percent (100%) of those quantities of Licensed Products required set forth in each such forecast as being NCH's requirements of Licensed Products for the first 3 (three) months of the Forecast shall constitute a confirmed order. The remaining 9 (nine) months of the Forecast shall not be deemed binding on either SIRTON or GENTIUM.
4.3 GENTIUM shall notify SIRTON, as soon as possible, of anything that could alter the Forecasts it had provided.
4.4 While everything governing SIRTON’s responsibility still holds, the latter shall immediately notify GENTIUM of anything it becomes aware of that could hinder feasibility of the Forecasts.
4.5 SIRTON is responsible for storing the Components (with the exception of the Active Principle). It ensues that GENTIUM shall pay exclusively for the Components purchased according to the confirmed orders and the forecasts for the first 3 months.
4.6 GENTIUM shall send SIRTON a purchase order for Products at least three (3) months of each twelve (12) month period. NCH shall communicate any changes to its forecasts as soon as the changes are known by NCH. NCH shall use commercially reasonable efforts to ensure the accuracy of its forecasts. Supplier shall, no later than ten (10) business days after receipt of each such forecast, notify NCH in writing of any prospective problems of which it is aware that might prevent it from meeting NCH's forecasted order quantities or estimated delivery dates. Unless Supplier so informs NCH that it would have problems in meeting NCH's forecasted requirements, Supplier shall be obligated to use commercially reasonable efforts to deliver during any calendar year, pursuant to purchase orders provided under Section 3.2 of this Agreement, up to one hundred twenty percent (120%) of NCH's forecasted purchases for that calendar year. Supplier shall further use commercially reasonable efforts to comply with orders for Licensed Products in excess of such one hundred twenty percent (120%) amount.
3.2 At least four (4) weeks prior to the date on which NCH desires to have Product delivered, NCH shall furnish to Supplier a binding purchase order for the quantity of delivery for said Licensed Products which NCH shall purchase and Supplier shall deliver, which orders shall be consistent with its forecasts. Supplier shall, within five (5) business days after its receipt of such purchase order.
4.7 SIRTON shall send GENTIUM a written , acknowledge such receipt and confirm that the order confirmation confirming the quantities and delivery date indicated in can be supplied. Should Supplier fail to do so, then the purchase order within 10 (ten) days of receipt thereof. Once confirmed, the order shall be deemed binding for SIRTONto have been accepted by Supplier. If GENTIUM does not receive any response from SIRTON within 10 (ten) days, the Each such purchase order shall be deemed confirmeddesignate the quantity of Licensed Products ordered and the date by which Supplier must deliver the Licensed Products to NCH.
4.8 SIRTON 3.3 Supplier shall meet use commercially reasonable efforts to accommodate any NCH requests for Licensed Products in excess of the delivery date indicated on the corresponding quantities described in any previously-submitted purchase order, or for delivery of Licensed Product sooner than that allowed pursuant to this Article 3. Upon thirty (30) days Should NCH's business conditions necessitate reduction or delay in purchase order requirements, then Supplier shall use its commercially reasonable efforts to implement such requested changes. Notwithstanding the foregoing, Supplier shall not take any action in response to any such requests which would result in charges to NCH in addition to those set forth in the respective purchase order without NCH's prior notice, SIRTON shall guarantee the availability of an addition-extra batch above and beyond the amount for the order confirmedwritten consent.
4.9 For 3.4 If for any reason Supplier experiences any shortage of any input used by Supplier in manufacturing the entire duration of the present ContractLicensed Products, SIRTON shall have on hand including without limitation, Raw Materials, labor and plant capacity (each an adequate stock of Components able "Input"), and is therefore unable to fill the orders confirmed as indicated in Paragraph 4.8 and adequate for an additional production batch as reported in Paragraph 4.8.
4.10 If the variation in the packaging materials is required due to changes in the reference standards or decided at the discretion of GENTIUM, the latter shall bear any additional costs. Nevertheless, GENTIUM shall not bear the costs for the packaging materials if they do not comply supply NCH with the specifications defined full quantity of Licensed Products ordered by it and forwarded accepted by GENTIUM as indicated in Paragraph 6.4.
4.11 In Supplier by the case in which (i) SIRTON does not deliver the Products at the deadline indicated date set forth in the purchase order, and (ii) if SIRTON itself is responsible for said delay, SIRTON then NCH shall pay GENTIUM, as penalty, be entitled to the following sums:
(a) If the delay falls between 1 (one) and 2 (two) weeks, a sum equal to 5.00% same proportionate quantity of the amount due it from GENTIUM Input as outlined in Attachment 2;
(b) If the delay exceeds 2 (due) weeks, a sum equal to 10.00% quantity of the amount due it from GENTIUM as outlined Input used by Supplier in Attachment 2. In both manufacturing Licensed Products for NCH in the above casestwelve (12) months preceding the shortage bears to the total quantity of the Input used by Supplier in manufacturing products for all its customers, it remains understood that the amount to be paid by SIRTON as penalty during such period.
3.5 NCH shall be automatically compensated and detracted liable for obsolescence of Raw Materials resulting from the amount due NCH switching to be paid by GENTIUM in compliance with Article 5 belowan alternate supplier pursuant to Section 2.4.
4.12 SIRTON shall guarantee that the number of Products per Active Principle meets the minimum quantities that can be obtained, for concentrates and standard batches, as better defined in the Technical Agreement. If the minimum quantities are not met, SIRTON shall reimburse GENTIUM the costs for production of the extra Active Principle used, as determined according to what is indicated in Attachment 2.
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Forecasts and Orders. Forecasts:
4.1 GENTIUM Beginning no later than six (6) Months prior to placing its initial Purchase Order for Product (it being understood that a forecast for a Calendar Quarter may be zero), prior to the first day of each calendar quarter (beginning each 1st January, 1st April, 1st July and 1st October and each referred to herein as a “Calendar Quarter”), CLEARSIDE BIOMEDICAL shall provide SIRTON GERRESHEIMER with a written rolling forecast schedule of its projected orders for the Products for at least the following four (4) Calendar Quarters (“Forecast Schedule”). The initial forecast will be provided by July 1, 2018 and is expected to reflect projected orders of between [***] units of Product requirements for the following 12 (twelve4) months Calendar Quarters. Beginning with the first Forecast Schedule submitted after the one year anniversary of the first commercial sale of the Product to a Third Party (the “ForecastCommercial Launch Anniversary”), and SIRTON shall plan all its activities with CLEARSIDE BIOMEDICAL to notify GERRESHEIMER forthwith in relation to Manufacturing writing of the products against said forecastdate of the Commercial Launch. Said Forecasts shall contain Subject to Clause 4.4, CLEARSIDE BIOMEDICAL can only vary the requirements forecast amounts for the second Calendar Quarter of a Forecast Schedule in terms the next subsequent Forecast Schedule by +/- [***], and can only vary the forecast amounts for the third Calendar Quarter of number a Forecast Schedule in the next subsequent Forecast Schedule by +/- [***]. If CLEARSIDE BIOMEDICAL desires to vary the forecasted amounts by an additional [***] up to [***] or up to [***] respectively, then (i) in case of pieces per month. SIRTON shall provide GENTIUM with a written reply an increase, GERRESHEIMER agrees to notify Buyer within 10 five (ten5) days of Business Days after receipt of said Forecastsuch request, informing GENTIUM whether the ordered additional quantities of Products set forth in the overall feasibility request are exceeding the Sprint Capacity and whether such exceeding quantities can be delivered or not. In any event GERRESHEIMER will use reasonable efforts to fulfill this additional demand. In the event such excess quantities of the same. IfProduct directly results in additional costs, within 10 (ten) days, GENTIUM does not receive any response from SIRTON regarding the Forecast, feasibility of the latter such costs shall be deemed confirmed documented by SIRTONGERRESHEIMER and the Parties shall discuss in good faith such costs and what part thereof CLEARSIDE BIOMEDICAL may need to reimburse before any such costs are incurred and/or committed. If GERRESHEIMER, despite using reasonable efforts, cannot meet such excess quantities, the failure to supply the excess quantities shall not be regarded as a Failure to Supply; or (ii) in case of a decrease, if such decrease directly results in additional costs, such costs shall be documented by GERRESHEIMER and the CLEARSIDE BIOMEDICAL shall reimburse to GERRESHEIMER all such documented costs. For the avoidance of doubt, the maximum quantities of Products to be supplied by GERRESHEIMER during any six (6) Month period prior to the Commercial CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Launch Anniversary shall be [***] units of Product and GERRESHEIMER shall be under no obligation whatsoever to supply any quantities of Product beyond that amount.
4.2 The quantity In addition to the Forecast Schedule, prior to the 1st September of Products required each Year after the commencement of the issuance of Forecast Schedules, CLEARSIDE BIOMEDICAL shall provide on an annual basis a two (2) Year non-binding forecast of projected orders for the first 3 (three) months of the Forecast shall constitute a confirmed order. The remaining 9 (nine) months of the Forecast shall not Products to be deemed binding on either SIRTON or GENTIUMused by GERRESHEIMER solely for planning purposes.
4.3 GENTIUM The Products detailed in the first Calendar Quarter of each Forecast Schedule (“Firm Order”) will be binding on both Parties. CLEARSIDE BIOMEDICAL shall notify SIRTONissue purchase orders against each Firm Order (each a “Purchase Order”), as soon as possible, which Purchase Order shall include the requested delivery dates. GERRESHEIMER shall respond to each Purchase Order received from CLEARSIDE BIOMEDICAL within ten (10) Business Days of anything that could alter the Forecasts it had provided.
4.4 While everything governing SIRTON’s responsibility still holds, the latter receipt. The response of GERRESHEIMER shall immediately notify GENTIUM of anything it becomes aware of that could hinder feasibility include confirmation of the Forecasts.
4.5 SIRTON is responsible for storing the Components (with the exception of the Active Principle). It ensues delivery dates; PROVIDED, HOWEVER, that GENTIUM shall pay exclusively for the Components purchased according to the confirmed orders and the forecasts for the first 3 months.
4.6 GENTIUM shall send SIRTON GERRESHEIMER may not reject any quantities forecasted in a purchase order for Products at least three (3) months prior to the date of delivery for said order.
4.7 SIRTON shall send GENTIUM a written order confirmation confirming the quantities and Firm Order or any delivery date indicated in the purchase order within 10 (ten) days of receipt thereof. Once confirmed, the order shall be deemed binding for SIRTON. If GENTIUM does not receive any response from SIRTON within 10 (ten) days, the order shall be deemed confirmed.
4.8 SIRTON shall meet the delivery date indicated on the corresponding purchase order. Upon that is more than thirty (30) days prior noticefrom the date the applicable Purchase Order is submitted. GERRESHEIMER’s failure to reject any portion of a Purchase Order within the applicable ten (10) Business Day period shall be deemed to be GERRESHEIMER’s acceptance thereof. In the event that either Party requires amendments to the quantities ordered, SIRTON the timing of production and/or delivery, the relevant planning personnel from both Parties shall guarantee within ten (10) Business Days of receipt of a Forecast Schedule, Firm Order or Purchase Order discuss in good faith and agree amendments to the availability Forecast Schedule, Firm Order or Purchase Order.
4.4 CLEARSIDE BIOMEDICAL and/or its Affiliates shall use commercially reasonable endeavours not to, at any one time, collectively place Firm Orders at a level that would require an aggregate capacity at GERRESHEIMER greater than the maximum manufacturing capacity of an addition-extra batch above the Manufacturing Site as set forth in the applicable Product Schedule (“Sprint Capacity”) and beyond GERRESHEIMER shall not be obliged to supply Products in excess of the amount Sprint Capacity. In the event that the aggregate CLEARSIDE BIOMEDICAL demand is greater than the Sprint Capacity CLEARSIDE BIOMEDICAL shall promptly instruct GERRESHEIMER the order of preference for the order confirmeddeliveries.
4.9 For the entire duration of the present Contract, SIRTON shall have on hand an adequate stock of Components able to fill the orders confirmed as indicated in Paragraph 4.8 and adequate for an additional production batch as reported in Paragraph 4.8.
4.10 If the variation in the packaging materials 4.5 It is required due to changes in the reference standards or decided at the discretion of GENTIUM, the latter shall bear any additional costs. Nevertheless, GENTIUM shall not bear the costs for the packaging materials if they do not comply with the specifications defined and forwarded by GENTIUM as indicated in Paragraph 6.4.
4.11 In the case in which (i) SIRTON does not deliver the Products at the deadline indicated in the purchase order, and (ii) if SIRTON itself is responsible for said delay, SIRTON shall pay GENTIUM, as penalty, the following sums:
(a) If the delay falls between 1 (one) and 2 (two) weeks, a sum equal to 5.00% of the amount due it from GENTIUM as outlined in Attachment 2;
(b) If the delay exceeds 2 (due) weeks, a sum equal to 10.00% of the amount due it from GENTIUM as outlined in Attachment 2. In both the above cases, it remains understood that the amount remaining three (3) Calendar Quarters of the Forecast Schedule constitutes an estimate of the future Product requirement of CLEARSIDE BIOMEDICAL and its Affiliates and does not constitute a binding commitment by CLEARSIDE BIOMEDICAL or its Affiliates to order or purchase such Product.
4.6 For certain long lead time materials, as defined in good faith between the Parties, which requires GERRESHEIMER to place orders with a minimum lead time longer than three (3) Months in advance of manufacturing, GERRESHEIMER will be entitled to place those orders based on the projections set forth in a Forecast CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Schedule, and CLEARSIDE BIOMEDICAL agrees to pay for any such Materials which are not used in Firm Orders of Products placed by CLEARSIDE BIOMEDICAL and/or its Affiliates and cannot otherwise be used by GERRESHEIMER.
4.7 CLEARSIDE BIOMEDICAL may from time to time provide GERRESHEIMER with individual purchase orders for Products in addition to the quantities set forth in Firm Orders. GERRESHEIMER shall respond to each such individual purchase order received from CLEARSIDE BIOMEDICAL or an Affiliate of CLEARSIDE BIOMEDICAL within ten (10) Business Days of receipt. The response shall include confirmation or not of the Delivery dates and quantity as set out in such individual purchase order. GERRESHEIMER’s failure to reject any portion of such Purchase Order within the applicable ten (10) Business Day period shall be deemed to be paid by SIRTON GERRESHEIMER’s acceptance thereof.
4.8 If a CLEARSIDE BIOMEDICAL Affiliate desires to purchase the Product from GERRESHEIMER under the terms of this Agreement the Parties will consider the appropriate contractual mechanisms for the CLEARSIDE BIOMEDICAL Affiliate to receive Product from GERRESHEIMER or its Affiliates (as penalty shall be automatically compensated the case may be) and detracted benefit from the amount due terms of this Agreement, taking into account the CLEARSIDE BIOMEDICAL Affiliate may need to enter into separate legal agreements with GERRESHEIMER. For the avoidance of doubt, before the aforementioned contractual mechanism has been agreed by the Parties, GERRESHEIMER shall not be paid obliged to sell (and/or deliver) any Products to CLEARSIDE BIOMEDICAL Affiliates or fulfil or accept purchase orders from CLEARSIDE BIOMEDICAL Affiliates. GERRESHEIMER shall confirm promptly to CLEARSIDE BIOMEDICAL whether such CLEARSIDE BIOMEDICAL Affiliate is covered by GENTIUM in compliance with Article 5 below.
4.12 SIRTON shall guarantee that the number of Products per Active Principle meets the minimum quantities that can be obtained, for concentrates and standard batches, as better defined in the Technical AgreementGERRESHEIMER’s trade credit insurance. If such COMPANY Affiliate is not covered by GERRESHEIMERs trade credit insurance, then GERRESHEIMER shall only provide such CLEARSIDE BIOMEDICAL Affiliate with the minimum quantities are not met, SIRTON shall reimburse GENTIUM the costs for production named Product upon receipt of the extra Active Principle used, as determined according to what is indicated in Attachment 2.a payment security from CLEARSIDE BIOMEDICAL by means of a payment guarantee of CLEARSIDE BIOMEDICAL or a bank guarantee of an internationally business bank rated with triple B.
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