Supply & Term. (a) COLLAGENEX shall supply URL/MUTUAL with [**] Bottles of the Initial Quantity of CollaGenex Supplied Product (the "Initial Shipment") on or before the later of (i) April 8, 2004 and (ii) [**] Business Days after the Effective Date (the "Initial Shipment Date"). COLLAGENEX shall supply URL/MUTUAL with [**] Bottles of the Initial Quantity of CollaGenex Supplied Product (the "Second Shipment") on or before the later of (i) [**] and (ii) [**] Business Days after the Effective Date (the "Second Shipment Date"). COLLAGENEX understands that URL/Mutual expects to begin to supply COLLAGENEX Supplied Product for sale to URL/MUTUAL's distributors and other customers in the Territory pursuant to the provisions of this Agreement on or about April 8, 2004; provided, however, that if the Effective Date does not occur before April 8, 2004, then COLLAGENEX shall not be required to ship the Initial Quantity until [**] days after the Effective Date. The provisions of Section 4.2(d)(ii) shall apply to any delays in the shipments of the Initial Shipment or the Second Shipment. URL/MUTUAL shall use its commercially reasonable efforts to sell COLLAGENEX Supplied Product to its distributors and other customers in the Territory, which sales shall be solely pursuant to the terms hereof during the Supply Term. (b) Upon the written request of URL/MUTUAL in the event of a Competitive Generic Entry, the Supply Term may be extended up to [**] days beyond the otherwise applicable Supply Termination Date in order for URL/MUTUAL to engage in the necessary ordering and production activities to support the launch of the URL/MUTUAL Product provided that neither URL nor Mutual is, at the time of such request, in material breach of any of its obligations under the terms of the Agreement and provided that the Supply Term shall, under no circumstances, be deemed to extend past the expiration of the Patents or the earlier final determination by a court of competent jurisdiction, from which no appeal has been taken or all appeals have been exhausted, adjudicating the Patents to be invalid or unenforceable. (c) The Parties agree that URL/MUTUAL shall not be obligated to accept any COLLAGENEX Supplied Product for which the expiration date is less than [**] months after the date shipped by COLLAGENEX.
Appears in 1 contract
Samples: License and Supply Agreement (Collagenex Pharmaceuticals Inc)
Supply & Term. (a) COLLAGENEX The terms of this Section 5 shall supply URL/MUTUAL with [**] Bottles be effective as of the Initial Quantity of CollaGenex Supplied Product Second Amendment Effective Date and, unless this Agreement is earlier terminated pursuant to Section 14, shall remain in effect only until terminated in accordance with this Section 5 (the "Initial Shipment"“Supply Term”). The initial term for the supply of Drug Substance under this Section 5 shall be for ten (10) on or before the later of (i) April 8, 2004 and (ii) [**] Business Days years after the Second Amendment Effective Date (the "“Initial Shipment Date"Supply Term”). COLLAGENEX If Protalix determines not to extend the supply of Drug Substance to Pfizer hereunder beyond such Initial Supply Term, Protalix shall supply URL/MUTUAL with [**] Bottles have the right to provide written notice of termination of the Supply Term, at least three (3) years prior to the effective date of termination of the Supply Term set forth in such notice (which shall in no event be prior to the end of the Initial Quantity of CollaGenex Supplied Product Supply Term) (the "Second Shipment"“Supply Termination Notice”); provided that notwithstanding the timely issuance of a Supply Termination Notice by Protalix in accordance with the foregoing sentence Pfizer shall have the right to extend the Supply Term for up to two additional periods of thirty (30) on months each (each, a “Renewal Supply Term”) by providing to Protalix a written extension notice at least one (1) year prior to the end of the Initial Supply Term or before the later first Renewal Supply Term, as applicable (with the first Renewal Supply Term commencing at the end of the Initial Supply Term and the second Renewal Supply Term commencing at the end of the first Renewal Supply Term). For the avoidance of doubt, (i) [**] and (ii) [**] Business Days after the Effective Date (the "Second Shipment Date"). COLLAGENEX understands that URL/Mutual expects to begin to supply COLLAGENEX Supplied Product for sale to URL/MUTUAL's distributors and other customers in the Territory pursuant event Pfizer does not provide a written extension notice at least one (1) year prior to the provisions of this Agreement on or about April 8, 2004; provided, however, that if the Effective Date does not occur before April 8, 2004, then COLLAGENEX shall not be required to ship the Initial Quantity until [**] days after the Effective Date. The provisions of Section 4.2(d)(ii) shall apply to any delays in the shipments end of the Initial Shipment or Supply Term in accordance with the Second Shipment. URL/MUTUAL shall use its commercially reasonable efforts to sell COLLAGENEX Supplied Product to its distributors and other customers in the Territory, which sales shall be solely pursuant to the terms hereof during the Supply Term.
(b) Upon the written request of URL/MUTUAL in the event of a Competitive Generic Entryforegoing sentence, the Supply Term may be extended up to [**] days beyond shall terminate upon the otherwise applicable stated effective date of termination in the Supply Termination Date in order for URL/MUTUAL to engage Notice, (ii) in the necessary ordering and production activities event Pfizer provides a written extension notice for the first Renewal Supply Term in accordance with the foregoing sentence, but does not provide a written extension notice for the second Renewal Supply Term at least one (1) year prior to support the launch end of the URL/MUTUAL Product provided that neither URL nor Mutual isfirst Renewal Supply Term in accordance with the foregoing sentence, at the time of such request, in material breach of any of its obligations under the terms of the Agreement and provided that the Supply Term shall, under no circumstances, be deemed to extend past shall terminate upon the expiration end of the Patents or first Renewal Supply Term, and (iii) in the earlier final determination by event Pfizer provides a court of competent jurisdictionwritten extension notice for the first and second Renewal Supply Terms in accordance with the foregoing sentence, from which no appeal has been taken or all appeals have been exhausted, adjudicating the Patents to be invalid or unenforceable.
Supply Term shall terminate fifteen (c15) The Parties agree that URL/MUTUAL shall not be obligated to accept any COLLAGENEX Supplied Product for which the expiration date is less than [**] months years after the date shipped by COLLAGENEXSecond Amendment Effective Date.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Protalix BioTherapeutics, Inc.)
Supply & Term. (a) COLLAGENEX The terms of this Section 5 shall supply URL/MUTUAL with [**] Bottles be effective as of the Initial Quantity of CollaGenex Supplied Product Second Amendment Effective Date and, unless this Agreement is earlier terminated pursuant to Section 14, shall remain in effect only until terminated in accordance with this Section 5 (the "Initial Shipment"“Supply Term”). The initial term for the supply of Drug Substance under this Section 5 shall be for ten (10) on or before the later of (i) April 8, 2004 and (ii) [**] Business Days years after the Second Amendment Effective Date (the "“Initial Shipment Date"Supply Term”). COLLAGENEX If Protalix determines not to extend the supply of Drug Substance to Pfizer hereunder beyond such Initial Supply Term, Protalix shall supply URL/MUTUAL with [**] Bottles have the right to provide written notice of termination of the Supply Term, at least three (3) years prior to the effective date of termination of the Supply Term set forth in such notice (which shall in no event be prior to the end of the Initial Quantity of CollaGenex Supplied Product Supply Term) (the "Second Shipment"“Supply Termination Notice”); provided that notwithstanding the timely issuance of a Supply Termination Notice by Protalix in accordance with the foregoing sentence Pfizer shall have the right to extend the Supply Term for up to two additional periods of thirty (30) on months each (each, a “Renewal Supply Term”) by providing to Protalix a written extension notice at least one (1) year prior to the end of the Initial Supply Term or before the later first Renewal Supply Term, as applicable (with the first Renewal Supply Term commencing at the end of the Initial Supply Term and the second Renewal Supply Term commencing at the end of the first Renewal Supply Term). For the avoidance of doubt, (i) [**] and (ii) [**] Business Days after the Effective Date (the "Second Shipment Date"). COLLAGENEX understands that URL/Mutual expects to begin to supply COLLAGENEX Supplied Product for sale to URL/MUTUAL's distributors and other customers in the Territory pursuant event Pfizer does not provide a written extension notice at least one (1) year prior to the provisions of this Agreement on or about April 8, 2004; provided, however, that if the Effective Date does not occur before April 8, 2004, then COLLAGENEX shall not be required to ship the Initial Quantity until [**] days after the Effective Date. The provisions of Section 4.2(d)(ii) shall apply to any delays in the shipments end of the Initial Shipment or Supply Term in accordance with the Second Shipment. URL/MUTUAL shall use its commercially reasonable efforts to sell COLLAGENEX Supplied Product to its distributors and other customers in the Territory, which sales shall be solely pursuant to the terms hereof during the Supply Term.
(b) Upon the written request of URL/MUTUAL in the event of a Competitive Generic Entryforegoing sentence, the Supply Term may be extended up shall terminate upon the stated effective date of termination in the Supply Termination Notice, (ii) in the event Pfizer provides a written extension notice for the first Renewal Supply Term in accordance with the foregoing sentence, but does not provide a written extension notice for the second Renewal Supply Term at least one (1) year prior to the end of the first Renewal Supply Term in accordance with the foregoing sentence, the Supply Term shall terminate upon the end of the first Renewal Supply Term, and (iii) in the event Pfizer provides a written extension notice for the first and second Renewal Supply Terms in accordance with the foregoing sentence, the Supply Term shall terminate fifteen (15) years after the Second Amendment Effective Date. [**] days beyond the otherwise applicable Supply Termination Date in order for URL/MUTUAL to engage in the necessary ordering and production activities to support the launch of the URL/MUTUAL Product provided that neither URL nor Mutual is, at the time of such request, in material breach of any of its obligations under the terms of the Agreement and provided that the Supply Term shall, under no circumstances, be deemed to extend past the expiration of the Patents or the earlier final determination by a court of competent jurisdiction, from which no appeal has been taken or all appeals have been exhausted, adjudicating the Patents to be invalid or unenforceable.
(c) The Parties agree that URL/MUTUAL shall not be obligated to accept any COLLAGENEX Supplied Product for which the expiration date is less than [**] months after the date shipped by COLLAGENEXRedacted pursuant to confidential treatment request.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Protalix BioTherapeutics, Inc.)
Supply & Term. (a) COLLAGENEX GSK (or its Affiliate) shall supply URL/MUTUAL with [**] Bottles of the Initial Quantity of CollaGenex Supplied Product (the "Initial Shipment") on or before the later of (i) April 8, 2004 and (ii) [**] Business Days after the Effective Date (the "Initial Shipment Date"). COLLAGENEX shall supply URL/MUTUAL with [**] Bottles of the Initial Quantity of CollaGenex Supplied Product (the "Second Shipment") on or before the later of (i) [**] and (ii) [**] Business Days after the Effective Date (the "Second Shipment Date"). COLLAGENEX understands that URL/Mutual expects to begin use its Commercially Reasonable Efforts to supply COLLAGENEX PAR and its Affiliates with their entire commercial requirements of GSK Supplied Product for sale to URL/MUTUAL's PAR’s (and its Affiliates’) distributors and other customers solely in the Territory pursuant to the provisions of this Agreement on Agreement, including those provisions regarding the timing of such supply. GSK’s (or about April 8, 2004; provided, however, that if its Affiliate’s) supply obligation for GSK Supplied Product shall be for the Effective Date does not occur before April 8, 2004, then COLLAGENEX shall not be required to ship the Initial Quantity until [**] days after the Effective Date. The provisions of Section 4.2(d)(ii) shall apply to any delays in the shipments duration of the Initial Shipment or the Second Shipment. URL/MUTUAL shall use its commercially reasonable efforts Supply Term subject to sell COLLAGENEX Supplied Product to its distributors and other customers in the Territory, which sales shall be solely pursuant to the terms hereof during the Supply TermSection 4.1(b).
(b) Upon The Supply Term for the written request of URL/MUTUAL in Product may be extended for additional one (1) year periods beyond its then-applicable expiry date. In the event either Party wishes to extend the Supply Term for an additional one (1) year period beyond its applicable expiry date, such Party shall submit such request in writing to the other Party at least nine (9) months before the Supply Term’s then applicable expiry date. Within thirty (30) days after the receipt of such request, the recipient Party shall respond to the extension-requesting Party in writing as to whether or not the recipient Party accepts such request for a Competitive Generic Entryone (1) year extension of the Supply Term; provided, neither Party shall be bound to such extension until a Supply Price has been agreed-upon pursuant to Section 3.4(a). For the avoidance of doubt, GSK shall not be obligated to extend the Supply Term if, in GSK’s reasonable discretion, the Supply Price for the extension period should exceed the prices set forth in Schedule 3.4(a). Notwithstanding anything to the contrary, the Supply Term may be extended up to [**] days beyond the otherwise applicable Supply Termination Date in order for URL/MUTUAL to engage in the necessary ordering and production activities to support the launch shall automatically terminate as of the URL/MUTUAL Product provided that neither URL nor Mutual is, at the time of such request, in material breach of any of its obligations under the terms earlier of the date upon which this Agreement and provided that the Supply Term shall, under no circumstances, be deemed to extend past the expiration of the Patents terminates or the earlier final determination by a court of competent jurisdiction, from which no appeal has been taken or all appeals have been exhausted, adjudicating the Patents to be invalid or unenforceableexpires for any reason.
(c) The Parties agree that URL/MUTUAL shall not be obligated to accept any COLLAGENEX Supplied Product for which In the expiration date is less than event the Launch Date occurs [***], PAR (and its Affiliates) hereby acknowledge and agree that [***]. In the event [***] months after pursuant to the date shipped by COLLAGENEXprovisions of this Agreement. [***]
(d) [* * *], such product shall [***] shall be deemed to [* * *] provided, if [***]. For the avoidance of doubt, [* * *].
Appears in 1 contract
Samples: Supply and Distribution Agreement (Spectrum Pharmaceuticals Inc)