Firm Orders. 3.3.1. The Company agrees to supply to Sandoz [*] quantities of the Product ordered by Sandoz pursuant to one or more purchase orders issued in accordance with the terms and conditions hereof (each, as accepted by the Company in accordance with Section 3.3.2, a “Firm Order”). Sandoz shall issue Firm Orders to the Company for the purchase of the quantities described therein, and upon acceptance by the Company in accordance with Section 3.3.2, each Firm Order shall be considered a binding, non-cancellable commitment upon the Company to produce and deliver such quantities of Product on the delivery dates described therein and upon Sandoz to purchase and pay for such quantities of Product. 3.3.2. The Company shall confirm to Sandoz all Firm Orders, including quantities, pricing, commercial terms, and delivery dates, in writing within [*] after receipt (or within a reasonable period of time after receipt for orders in excess of the Firm Commitment). Any such confirmation shall either confirm the delivery date set out in the Firm Order or provide a reasonable alternative delivery date. Any Firm Orders not expressly accepted or rejected by the Company shall be deemed to have been accepted. The Company may reject any Firm Order in excess of the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, that the Company shall [*] to supply Sandoz with quantities of Product which are in excess of the quantities specified in the Firm Commitment, subject to [*]. For clarity, the Company will not be considered in breach or default if it does not supply quantities of Product which are in excess of the quantities specified in the Firm Commitment after [*]. [*] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment has been required with respect to this omitted information. 3.3.3. Sandoz shall provide each Firm Order to the Company concurrently with the submission of each Rolling Forecast, and (a) with respect to Product quantities for Launch at least [*] prior to the delivery date specified therein and (b) with respect to all subsequent quantities of Product, at least [*] prior to the delivery date specified therein. Each Firm Order shall specify: (i) purchase order number; (ii) the name and quantities of the Product to be purchased by and supplied to Sandoz; (iii) the delivery dates and shipping instructions with respect thereto; (iv) Supply Price of the Product; (v) payment terms; and (vi) any other elements necessary to ensure the timely production and delivery of the Product. Each Firm Order shall constitute a contract, and the Parties shall comply in all respects with the obligations set forth therein including, without limitation, the obligation of the Company to deliver the Product on the delivery date set forth in the Firm Order; provided, however, that except for the information specified in clauses (ii) and (iii) of this Section, the supply, purchase and sale of the Products shall be governed solely by this Agreement and any additional or contrary terms or provisions contained in any Firm Order, purchase order or similar form or invoice or acknowledgment shall be void and have no force or effect.
Appears in 2 contracts
Sources: Distribution and Commercialization Agreement, Distribution and Commercialization Agreement (Adamis Pharmaceuticals Corp)
Firm Orders. 3.3.1. The Company agrees to supply to Sandoz (i) Concurrent with the delivery of the then-current Rolling Forecast, VF will issue a new firm written order in the form of a purchase order (specifying the Delivery Date or Delivery Dates that are at least [***] quantities days after the date of the Product ordered by Sandoz pursuant to one or more respective purchase orders issued in accordance with the terms and conditions hereof order) (each, as accepted by the Company in accordance with Section 3.3.2, a “Firm Order”). Sandoz shall issue Firm Orders to the Company ) for the purchase deliveries of the quantities described thereinBulk Drug Products to VF, and upon acceptance by the Company in accordance with Section 3.3.2, each Firm Order shall be considered a binding, non-cancellable commitment upon the Company to produce and deliver such quantities of Product on the delivery dates described therein and upon Sandoz to purchase and pay for such quantities of Product.
3.3.2. The Company shall confirm to Sandoz all Firm Orders, including quantities, pricing, commercial terms, and delivery dates, in writing within [*] after receipt (or within a reasonable period of time after receipt for orders in excess of the Firm Commitment). Any such confirmation shall either confirm the delivery date set out in the Firm Order or provide a reasonable alternative delivery date. Any Firm Orders not expressly accepted or rejected by the Company shall be deemed to have been accepted. The Company may reject any Firm Order in excess of the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, ensuring that the Company shall [*] to supply Sandoz with quantities of Product which are in excess of the quantities specified in the Firm Commitment, subject to [*]. For clarity, the Company will not be considered in breach or default if it does not supply quantities of Product which are in excess of the quantities specified in the Firm Commitment after [*]. [*] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment CCX always has been required with respect to this omitted information.
3.3.3. Sandoz shall provide each Firm Order to the Company concurrently with the submission of each Rolling Forecast, and (a) with respect to Product quantities for Launch at least [***] prior days lead-time to deliver Bulk Drug Product to VF. When accepted by CCX as specified below, such Firm Order for CCX to Manufacture and deliver the delivery date specified therein and (b) with respect to all subsequent quantities agreed quantity of Productthe Bulk Drug Products. In case of first launch, at least [***] calendar days prior to the delivery date specified thereinrequested initial Shipping Date of Bulk Product or as soon as practicable after the Effective Date of this Agreement, VF shall place an initial purchase order. Each CCXI will confirm receipt of such request and will use commercially reasonable efforts to accept and fulfill such purchase order.
(ii) Firm Order shall specify: (i) Orders submitted to CCX will specify VF’s purchase order number; (ii) the name , quantities by Bulk Drug Product type, Delivery Date, and delivery location. The quantities of Bulk Drug Products ordered and Delivery Dates in those Firm Orders will be firm and binding on VF and CCX (unless rejected under Section 5.1(d)) and may not be reduced by VF or CCX except as expressly permitted in this Agreement. Expedited Firm Orders will be subject to additional fees as agreed in writing by the Product to be purchased by and supplied to Sandoz; Parties.
(iii) If and when VF applies for a tender of Product to a Governmental Authority or if VF prepares for a launch of Product in a country, or if VF requires Product prior to a launch date due to e.g., regulatory requirements as part of a submission, VF shall notify CCXI in writing and provide to CCXI information relating to the delivery dates and shipping instructions with respect thereto; (iv) Supply Price of the Product; (v) payment terms; and (vi) any other elements necessary anticipated volumes to ensure the timely production and delivery of the Product. Each Firm Order shall constitute a contract, be supplied under such tender or launch and the Parties shall comply in all respects with the obligations set forth therein including, without limitationtiming for deliveries thereunder. In such events, the obligation Parties will discuss in good faith reasonable mechanisms for CCXI to provide supply of the Company Product for such tender or launch The Parties agree that lead times for such orders related to deliver the Product on the delivery date set forth in the Firm Order; provided, however, that except for the information specified in clauses (ii) and (iii) of this Section, the supply, purchase and sale of the Products shall be governed solely by this Agreement and any additional or contrary terms or provisions contained in any Firm Order, purchase order or similar form or invoice or acknowledgment shall be void and a tender and/or a launch may have no force or effectshorter lead times than regular orders.
Appears in 1 contract
Sources: Manufacturing and Supply Agreement (ChemoCentryx, Inc.)
Firm Orders. 3.3.1. The Company agrees to supply to Sandoz [On or before the *] quantities *** of each ****, the Product ordered by Sandoz pursuant to one or more purchase orders issued in accordance with the terms and conditions hereof Client shall issue a firm written order (each, as accepted by the Company in accordance with Section 3.3.2, a “Firm Order”). Sandoz shall issue Firm Orders ) for Manufacturing in respect of the Products to be produced and released to the Company for Client on one (1) or more dates not less than **** from the purchase first day of the quantities described therein, and upon acceptance by calendar month immediately following the Company in accordance with Section 3.3.2, each Firm Order shall be considered a binding, non-cancellable commitment upon the Company to produce and deliver such quantities of Product on the delivery dates described therein and upon Sandoz to purchase and pay for such quantities of Product.
3.3.2. The Company shall confirm to Sandoz all Firm Orders, including quantities, pricing, commercial terms, and delivery dates, in writing within [*] after receipt (or within a reasonable period of time after receipt for orders in excess of the Firm Commitment). Any such confirmation shall either confirm the delivery date set out in that the Firm Order or provide is submitted (each, a reasonable alternative delivery date“Delivery Date”). Any Firm Orders not expressly accepted or rejected For clarity, Products will be placed at Client’s disposal for collection by Client’s carrier on the Company date of release by Patheon Quality Control. Such date of Patheon Quality Control release shall be deemed to have been acceptedbe the Delivery Date. The Company may reject any Such Firm Order in excess of Orders submitted to Patheon shall specify the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, that the Company shall [*] to supply Sandoz with quantities of Product which are in excess of the quantities specified in the Firm Commitment, subject to [*]. For clarity, the Company will not be considered in breach or default if it does not supply quantities of Product which are in excess of the quantities specified in the Firm Commitment after [*]. [*] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment has been required with respect to this omitted information.
3.3.3. Sandoz shall provide each Firm Order to the Company concurrently with the submission of each Rolling Forecast, and (a) with respect to Product quantities for Launch at least [*] prior to the delivery date specified therein and (b) with respect to all subsequent quantities of Product, at least [*] prior to the delivery date specified therein. Each Firm Order shall specify: (i) Client’s Manufacturing purchase order number; (ii) the name , quantities by Product type, monthly delivery schedule, shipment location and quantities of the Product to be purchased by and supplied to Sandoz; (iii) the delivery dates and shipping instructions with respect thereto; (iv) Supply Price of the Product; (v) payment terms; and (vi) any other elements necessary to ensure the timely production and delivery shipment of the ProductProducts. Each The quantities of Products ordered in such Firm Order shall constitute a contract, and the Parties shall comply in all respects with the obligations set forth therein including, without limitation, the obligation of the Company to deliver the Product on the delivery date set forth in the Firm Order; provided, however, that except for the information specified in clauses (ii) and (iii) of this Section, the supply, purchase and sale of the Products Orders shall be governed solely by this Agreement and ****. In the event that Client cancels **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. any additional or contrary terms or provisions contained in any part of a Firm Order, purchase order or similar form or invoice or acknowledgment Client shall be void responsible for **** of such cancelled part of a Firm Order, provided that if Client informs Patheon at any time during the **** of this Agreement, at **** prior to the commencement of dispensing, that it would like to cancel any or part of such Firm Order, then ****. Patheon shall indicate its acceptance of Firm Orders for the Product by promptly acknowledging acceptance of each Firm Order in writing within **** of its receipt; each such acceptance shall include, subject to Client confirmation, the Delivery Date for the Product ordered. The agreed upon Delivery Date may be amended from time to time by written agreement of the parties, with the newly agreed upon date becoming the new Delivery Date. For the avoidance of doubt, Patheon will accept all Firm Orders submitted by the Client for Product so long as ****. All Firm Orders will be deemed to incorporate all of the terms and have no force or effectconditions in this Agreement.
Appears in 1 contract
Sources: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Firm Orders. 3.3.1. The Company agrees to supply to Sandoz [*] quantities volume requirements for each Product as set forth for each of the first four (4) months of each such rolling forecast shall be a binding commitment to purchase the specified volumes of Product ordered by Sandoz pursuant (each such four-month period shall be referred to one or more purchase orders issued in accordance with herein as the terms and conditions hereof (each, as accepted by the Company in accordance with Section 3.3.2, a “Firm Order”). Sandoz Each requirement in the Firm Order shall specify the volumes of Products ordered, the Delivery Date and the destination for delivery of the Products. The Firm Orders may be delivered electronically or by other means to such location as Adolor shall designate. Adolor shall acknowledge and provide GSK with a written acceptance of each Firm Order within five (5) Business Days following Adolor’s receipt thereof. Adolor may reject only that portion of any Firm Order that it shall be unable to fill (a) due to a Force Majeure Event, (b) due to a shortage of API Compound, subject to allocation pursuant to Section 2.4, or (c) that is otherwise inconsistent with the rolling forecast. Adolor shall be obligated to make such Products available on the Delivery Date specified by GSK, provided that Adolor shall be entitled to deliver such Products any time within the three (3) day period prior to the Delivery Date. Subject to Section 3.5.1, in the event that Adolor shall not be able to make Product volumes available by the Delivery Date specified in a Firm Order, Adolor shall notify GSK within two (2) Business Days of its discovery of its inability to comply with the terms of this Section 2.2. Except as otherwise provided in this Agreement, all Firm Orders shall be binding on Adolor and GSK. GSK shall issue Firm Orders to Adolor not less than one hundred twenty (120) days prior to the Company earliest requested Delivery Date for any Products to be shipped pursuant to such Firm Order. Other than terms respecting quantity, Delivery Date, shipment method and destination, the purchase terms and conditions of the quantities described thereinany Firm Order submitted by GSK, or written acceptance thereof by Adolor shall be of no force and effect, whether or not objected to by Adolor or GSK, and upon acceptance by the Company nothing in accordance with Section 3.3.2, each Firm Order shall be considered a binding, non-cancellable commitment upon the Company to produce and deliver any such quantities of Product on the delivery dates described therein and upon Sandoz to purchase and pay for such quantities of Product.
3.3.2. The Company shall confirm to Sandoz all Firm Orders, including quantities, pricing, commercial terms, and delivery dates, in writing within [*] after receipt (or within a reasonable period of time after receipt for orders in excess of the Firm Commitment). Any such confirmation shall either confirm the delivery date set out in the Firm Order or provide a reasonable alternative delivery date. Any Firm Orders not expressly accepted or rejected by written acceptance shall supercede the Company shall be deemed to have been accepted. The Company may reject any Firm Order in excess terms and conditions of the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, that the Company shall [*] to supply Sandoz with quantities of Product which are in excess of the quantities specified in the Firm Commitment, subject to [*]. For clarity, the Company will not be considered in breach Collaboration Agreement or default if it does not supply quantities of Product which are in excess of the quantities specified in the Firm Commitment after [*]. [*] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment has been required with respect to this omitted informationQuality Agreement.
3.3.3. Sandoz shall provide each Firm Order to the Company concurrently with the submission of each Rolling Forecast, and (a) with respect to Product quantities for Launch at least [*] prior to the delivery date specified therein and (b) with respect to all subsequent quantities of Product, at least [*] prior to the delivery date specified therein. Each Firm Order shall specify: (i) purchase order number; (ii) the name and quantities of the Product to be purchased by and supplied to Sandoz; (iii) the delivery dates and shipping instructions with respect thereto; (iv) Supply Price of the Product; (v) payment terms; and (vi) any other elements necessary to ensure the timely production and delivery of the Product. Each Firm Order shall constitute a contract, and the Parties shall comply in all respects with the obligations set forth therein including, without limitation, the obligation of the Company to deliver the Product on the delivery date set forth in the Firm Order; provided, however, that except for the information specified in clauses (ii) and (iii) of this Section, the supply, purchase and sale of the Products shall be governed solely by this Agreement and any additional or contrary terms or provisions contained in any Firm Order, purchase order or similar form or invoice or acknowledgment shall be void and have no force or effect.
Appears in 1 contract
Sources: Row Supply Agreement (Adolor Corp)
Firm Orders. 3.3.1. The Company agrees to supply to Sandoz [On or before the *] quantities *** of each ****, the Product ordered by Sandoz pursuant to one or more purchase orders issued in accordance with the terms and conditions hereof Client shall issue a firm written order (each, as accepted by the Company in accordance with Section 3.3.2, a “Firm Order”). Sandoz shall issue Firm Orders ) for Manufacturing in respect of the Products to be produced and delivered to the Company for Client on one or more dates not less than**** from the purchase first day of the quantities described therein, and upon acceptance by calendar month immediately following the Company in accordance with Section 3.3.2, each Firm Order shall be considered a binding, non-cancellable commitment upon the Company to produce and deliver such quantities of Product on the delivery dates described therein and upon Sandoz to purchase and pay for such quantities of Product.
3.3.2. The Company shall confirm to Sandoz all Firm Orders, including quantities, pricing, commercial terms, and delivery dates, in writing within [*] after receipt (or within a reasonable period of time after receipt for orders in excess of the Firm Commitment). Any such confirmation shall either confirm the delivery date set out in that the Firm Order or provide is submitted (each, a reasonable alternative delivery date“Delivery Date”). Any Such Firm Orders not expressly accepted or rejected by submitted to Patheon shall specify the Company shall be deemed to have been accepted. The Company may reject any Firm Order in excess of the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, that the Company shall [*] to supply Sandoz with quantities of Product which are in excess of the quantities specified in the Firm Commitment, subject to [*]. For clarity, the Company will not be considered in breach or default if it does not supply quantities of Product which are in excess of the quantities specified in the Firm Commitment after [*]. [*] designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Confidential treatment has been required with respect to this omitted information.
3.3.3. Sandoz shall provide each Firm Order to the Company concurrently with the submission of each Rolling Forecast, and (a) with respect to Product quantities for Launch at least [*] prior to the delivery date specified therein and (b) with respect to all subsequent quantities of Product, at least [*] prior to the delivery date specified therein. Each Firm Order shall specify: (i) Client’s Manufacturing purchase order number; (ii) the name , quantities by Product type, monthly delivery schedule, shipment location and quantities of the Product to be purchased by and supplied to Sandoz; (iii) the delivery dates and shipping instructions with respect thereto; (iv) Supply Price of the Product; (v) payment terms; and (vi) any other elements necessary to ensure the timely production and delivery shipment of the ProductProducts. Each The quantities of Products ordered in such Firm Order Orders shall constitute be ****. If Client cancels any or part of a contract, and the Parties shall comply in all respects with the obligations set forth therein including, without limitation, the obligation of the Company to deliver the Product on the delivery date set forth in the Firm Order; provided, howeverClient shall be responsible for **** of such cancelled part of a Firm Order, provided that except for if Client informs Patheon at any time during the information specified in clauses (ii) and (iii) **** of this SectionAgreement, at **** prior to the supply, purchase and sale Delivery Date of the Products shall be governed solely by this Agreement and any additional or contrary terms or provisions contained in any Firm Order, purchase order that it would like to cancel any or similar form or invoice or acknowledgment part of such Firm Order, then ****. ****. Patheon shall indicate its acceptance of Firm Orders for the Product by promptly acknowledging acceptance of each Firm Order in writing within **** of its receipt; each such acceptance shall include, subject to Client confirmation, the Delivery Date for the Product ordered. The agreed upon Delivery Date may be void amended from time to time by written agreement of the parties, with the newly agreed upon date becoming the new Delivery Date. For the avoidance of doubt, Patheon will accept all Firm Orders submitted by the Client for Product so long as ****. **** ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ****. All Firm Orders will be deemed to incorporate all of the terms and have no force or effectconditions in this Agreement.
Appears in 1 contract
Sources: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)