Common use of Alternative Supply Clause in Contracts

Alternative Supply. Notwithstanding any provision herein to the contrary, in the event that (1) ACCESS is in default of its supply obligations under this Agreement with respect to three (3) accepted WYETH purchase orders within any twelve month period (a "Shortfall"), or (2) if during Manufacture or supply of the Product to WYETH there is a material violation of the requirements set forth in Sections 2.9, 3.1, 3.2, 3.4, 3.6. 3.8 or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a "Regulatory Shortfall") that is not cured within forty-five (45) days of the later to occur of the (i) date of the violation or (ii) notice to ACCESS of such violation, then WYETH, in addition to any other rights and remedies it may have, shall have the right to Manufacture the Product itself and/or qualify an alternative supplier of Product. ACCESS shall, at its cost, (a) cooperate with WYETH in the transfer of copies of the Confidential Information, technology and know-how necessary to Manufacture the Product to WYETH and/or its designated alternative supplier, (b) deliver to WYETH copies of such drawings, specifications, and other information in ACCESS's possession as may be necessary to Manufacture the Product or cause the Product to be Manufactured and (c) grant to WYETH a limited license in the Field under ACCESS's Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for WYETH's distribution of the Product in the Territory, the Product; provided that to the extent that such technology and know-how constitutes ACCESS Confidential Information (or any information constitutes Confidential Information of ACCESS's Third Party manufacturer) it shall be subject to the provisions of Article 9 and WYETH's designated alternative supplier shall be required to enter into a confidentiality agreement with ACCESS containing substantially the same terms as Article 9; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c). In addition to WYETH's aforementioned right to Manufacture the Product itself and/or qualify an alternative supplier of the Product by reason of a Shortfall, WYETH shall be relieved of its obligation to order its purchase requirements of the Product from ACCESS if ACCESS, for any reason, is unable, anticipates that it will be unable or is unwilling to supply Product meeting WYETH's forecasted requirements for a period of time of three (3) months until such ability or willingness to supply resumes; provided that WYETH shall continue to be relieved of its obligation to order its purchase requirements of Product from ACCESS to the extent necessary to fulfill any reasonable contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period. In the case of a Regulatory Shortfall, WYETH shall immediately be relieved of any obligation to order its purchase requirements of the Product from ACCESS and shall not be required to purchase or accept any Product from ACCESS until and unless the Regulatory Shortfall has been remedied. In the event that WYETH elects to manufacture the Product itself and/or qualify an alternative supplier of the Product in accordance with this Section 2.6, then ACCESS shall reimburse WYETH for WYETH's reasonable additional cost in obtaining and establishing an alternative supplier.

Alternative Supply. Notwithstanding any provision herein to the contrary, in the event that (1) ACCESS ULURU is in default of its supply obligations under this Agreement with respect to three two (32) accepted WYETH MXXXXX HOLDING purchase orders within any twelve month period (a "“Shortfall"”), or (2) if during Manufacture or supply of the Product to WYETH MXXXXX HOLDING there is a material violation of the requirements set forth in Sections 2.92.8, 3.1, 3.2, 3.4, 3.6. 3.8 or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a "“Regulatory Shortfall"”) that is not cured within forty-five thirty (4530) days of the later to occur of the (i) date of the violation or (ii) notice to ACCESS ULURU of such violation, then WYETHMXXXXX HOLDING, in addition to any other rights and remedies it may have, shall have the right to Manufacture the Product itself and/or qualify an alternative supplier of Product. ACCESS ULURU shall, at its cost, (a) cooperate with WYETH MXXXXX HOLDING in the transfer of copies of the Confidential Information, technology and know-how necessary to Manufacture the Product to WYETH MXXXXX HOLDING and/or its designated alternative supplier, (b) deliver to WYETH MXXXXX HOLDING copies of such drawings, specifications, and other information in ACCESS's ULURU’s possession as may be necessary to Manufacture the Product or cause the Product to be Manufactured and (c) grant to WYETH MXXXXX HOLDING a limited license in the Field under ACCESS's ULURU’s Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for WYETH's MXXXXX HOLDING’s distribution of the Product in the Territory, the Product; provided that to the extent that such technology and know-how constitutes ACCESS ULURU Confidential Information (or any information constitutes Confidential Information of ACCESS's ULURU’s Third Party manufacturer) it shall be subject to the provisions of Article 9 and WYETH's MXXXXX HOLDING’s designated alternative supplier shall be required to enter into a confidentiality agreement with ACCESS ULURU containing substantially the same terms as Article 9; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c). In addition to WYETH's MXXXXX HOLDING’s aforementioned right to Manufacture the Product itself and/or qualify an alternative supplier of the Product by reason of a Shortfall, WYETH MXXXXX HOLDING shall be relieved of its obligation to order its purchase requirements of the Product from ACCESS ULURU if ACCESSULURU, for any reason, is unable, anticipates that it will be unable or is unwilling to supply Product meeting WYETH's MXXXXX HOLDING’s forecasted requirements for a period of time of three (3) months until such ability or willingness to supply resumes; provided that WYETH MXXXXX HOLDING shall continue to be relieved of its obligation to order its purchase requirements of Product from ACCESS ULURU to the extent necessary to fulfill any reasonable contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period. In the case of a Regulatory Shortfall, WYETH MXXXXX HOLDING shall immediately be relieved of any obligation to order its purchase requirements of the Product from ACCESS ULURU and shall not be required to purchase or accept any Product from ACCESS ULURU until and unless the Regulatory Shortfall has been remedied. In Within thirty (30) days of signing this agreement ULURU will provide MXXXXX HOLDING with a copy of the event that WYETH elects manufacturing batch records in sufficient details to manufacture enable MXXXXX HOLDING to produce the Product itself and/or qualify an alternative supplier should ULURU be in violation of the Product in accordance with provisions of this Section Article 2.6, then ACCESS shall reimburse WYETH for WYETH's reasonable additional cost in obtaining and establishing an alternative supplier.

Alternative Supply. Notwithstanding any provision herein to the contrary, in the event that (1) ACCESS ULURU is in default of its supply obligations under this Agreement with respect to three one (31) accepted WYETH ORADISC purchase orders within any twelve month period (a "“Shortfall"”), or (2) if during Manufacture or supply of the Product to WYETH ORADISC there is a material violation of the requirements set forth in Sections 2.92.8, 3.1, 3.2, 3.4, 3.6. 3.8 or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a "“Regulatory Shortfall"”) that is not cured within forty-five ten (4510) days of the later to occur of the (i) date of the violation or (ii) notice to ACCESS ULURU of such violation, then WYETHORADISC, in addition to any other rights and remedies it may have, shall have the right to Manufacture the Product itself and/or qualify an alternative supplier of Product. ACCESS ULURU shall, at its cost, (a) cooperate with WYETH ORADISC in the transfer of copies of the Confidential Information, technology and know-how necessary to Manufacture the Product to WYETH ORADISC and/or its designated alternative supplier, (b) deliver to WYETH ORADISC copies of such drawings, specifications, and other information in ACCESS's ULURU’s possession as may be necessary to Manufacture the Product or cause the Product to be Manufactured and (c) grant to WYETH ORADISC a limited license in the Field under ACCESS's ULURU’s Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for WYETH's ORADISC’s distribution of the Product in the Territory, the Product; provided that to the extent that such technology and know-how constitutes ACCESS ULURU Confidential Information (or any information constitutes Confidential Information of ACCESS's ULURU’s Third Party manufacturer) it shall be subject to the provisions of Article 9 and WYETH's ORADISC’s designated alternative supplier shall be required to enter into a confidentiality agreement with ACCESS ULURU containing substantially the same terms as Article 9; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c). In addition to WYETH's ORADISC’s aforementioned right to Manufacture the Product itself and/or qualify an alternative supplier of the Product by reason of a Shortfall, WYETH ORADISC shall be relieved of its obligation to order its purchase requirements of the Product from ACCESS ULURU if ACCESSULURU, for any reason, is unable, anticipates that it will be unable or is unwilling to supply Product meeting WYETH's ORADISC’s forecasted requirements for a period of time of three (3) months until such ability or willingness to supply resumes; provided that WYETH ORADISC shall continue to be relieved of its obligation to order its purchase requirements of Product from ACCESS ULURU to the extent necessary to fulfill any reasonable contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period. In the case of a Regulatory Shortfall, WYETH ORADISC shall immediately be relieved of any obligation to order its purchase requirements of the Product from ACCESS ULURU and shall not be required to purchase or accept any Product from ACCESS ULURU until and unless the Regulatory Shortfall has been remedied. In the event that WYETH elects to manufacture the Product itself and/or qualify an alternative supplier of the Product in accordance with this Section 2.6, then ACCESS shall reimburse WYETH for WYETH's reasonable additional cost in obtaining and establishing an alternative supplier.

Alternative Supply. Notwithstanding any provision herein to the contrary, in the event that (1) ACCESS ULURU is in default of its supply obligations under this Agreement with respect to three (3) accepted WYETH DEXO purchase orders within any twelve month period (a "“Shortfall"”), or (2) the current manufacturing sites are deregulated, deregistered or requested to cease manufacture for any reason from manufacturing pharmaceutical products thereby restricting the sale of products to the TERRITORY or (3) if during Manufacture or supply of the Product to WYETH DEXO there is a material violation of the requirements set forth in Sections 2.92.8, 3.1, 3.2, 3.4, 3.6. 3.8 or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a "“Regulatory Shortfall"”) that is not cured within forty-five (45) days of the later to occur of the (i) date of the violation or (ii) notice to ACCESS ULURU of such violation, then WYETHDEXO, in addition to any other rights and remedies it may have, shall have the right to Manufacture the Product itself and/or qualify an alternative registered pharmaceutical supplier of Product; provided that such right shall be subject to the parties mutually agreeing upon a royalty arrangement that would reflect ULURU’s lost manufacturing margin resulting from such transfer of manufacturing. ACCESS ULURU shall, at its cost, (a) cooperate with WYETH DEXO in the transfer of copies of the Confidential Information, technology and know-how necessary to Manufacture the Product to WYETH DEXO and/or its designated alternative supplier, (b) deliver to WYETH DEXO copies of such drawings, specifications, and other information in ACCESS's ULURU’s possession as may be necessary to Manufacture the Product or Product, cause the Product to be Manufactured or in order to effect a pharmaceutical marketing authorization within the TERRITORY and (c) grant to WYETH DEXO a limited license in the Field under ACCESS's ULURU’s Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for WYETH's DEXO’s distribution of the Product in the Territory, the Product; provided that to the extent that such technology and know-how constitutes ACCESS ULURU Confidential Information (or any information constitutes Confidential Information of ACCESS's ULURU’s Third Party manufacturer) it shall be subject to the provisions of Article 9 and WYETH's DEXO’s designated alternative supplier shall be required to enter into a confidentiality agreement with ACCESS ULURU containing substantially the same terms as Article 9; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c). In addition to WYETH's DEXO’s aforementioned right to Manufacture the Product itself and/or qualify an alternative supplier of the Product by reason of a Shortfall, WYETH DEXO shall be relieved of its obligation to order its purchase requirements of the Product from ACCESS ULURU if ACCESSULURU, for any reason, is unable, anticipates that it will be unable or is unwilling to supply Product meeting WYETH's DEXO’s forecasted requirements for a period of time of three (3) months until such ability or willingness to supply resumes; provided that WYETH DEXO shall continue to be relieved of its obligation to order its purchase requirements of Product from ACCESS ULURU to the extent necessary to fulfill any reasonable contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period. In the case of a Regulatory Shortfall, WYETH DEXO shall immediately be relieved of any obligation to order its purchase requirements of the Product from ACCESS ULURU and shall not be required to purchase or accept any Product from ACCESS ULURU until and unless the Regulatory Shortfall has been remedied. In the event that WYETH DEXO elects to manufacture the Product itself and/or qualify an alternative supplier of the Product in accordance with this Section 2.6, then ACCESS ULURU shall reimburse WYETH DEXO for WYETH's DEXO’s reasonable additional cost in obtaining and establishing an alternative alternateive supplier. In the event of ULURU ceasing to be the manufacturer of the product ULURU commits to retain all manufacturing batch records for a period of seven (7) years.

Alternative Supply. Notwithstanding any provision herein to the contrary, in the event that (1) ACCESS ULURU is in default of its supply obligations under this Agreement with respect to three two (32) accepted WYETH ALTRAZEAL purchase orders within any twelve month period (a "Shortfall"), or (2) if during Manufacture or supply of the Product to WYETH ALTRAZEAL there is a material violation of the requirements set forth in m Sections 2.92.8, 3.1, 3.2, 3.4, 3.6. 3.8 or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a "Regulatory Shortfall") that is not cured within forty-five thirty (4530) days of the later to occur of the (i) date of the violation or (ii) notice to ACCESS ULURU of such violation, then WYETHALTRAZEAL, in addition to any other rights and remedies it may have, shall have the right to Manufacture the Product itself and/or qualify an alternative supplier of Product. ACCESS ULURU shall, at its cost, (a) cooperate with WYETH ALTRAZEAL in the transfer of copies of the Confidential Information, technology and know-how necessary to Manufacture the Product to WYETH ALTRAZEAL and/or its designated alternative supplier, (b) deliver to WYETH ALTRAZEAL copies of such drawings, specifications, and other information in ACCESSULURU's possession as may be necessary to Manufacture the Product or cause the Product to be Manufactured and (c) grant to WYETH ALTRAZEAL a limited license in the Field under ACCESSULURU's Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for WYETH's ALTRAZEAL’s distribution of the Product in the Territory, the Product; provided that to the extent that such technology and know-how constitutes ACCESS ULURU Confidential Information (or any information constitutes Confidential Information of ACCESSULURU's Third Party manufacturer) it shall be subject to the provisions of Article 9 and WYETH's ALTRAZEAL’s designated alternative supplier shall be required to enter into a confidentiality agreement with ACCESS ULURU containing substantially the same terms as Article 9; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c). In addition to WYETH's ALTRAZEAL’s aforementioned right to Manufacture the Product itself and/or qualify an alternative supplier of the Product by reason of a Shortfall, WYETH ALTRAZEAL shall be relieved of its obligation to order its purchase requirements of the Product from ACCESS ULURU if ACCESSULURU, for any reason, is unable, anticipates that it will be unable or is unwilling to supply Product meeting WYETH's ALTRAZEAL’s forecasted requirements for a period of time of three (3) months until such ability or willingness to supply resumes; provided that WYETH ALTRAZEAL shall continue to be relieved of its obligation to order its purchase requirements of Product from ACCESS ULURU to the extent necessary to fulfill any reasonable contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period. In the case of a Regulatory Shortfall, WYETH ALTRAZEAL shall immediately be relieved of any obligation to order its purchase requirements of the Product from ACCESS ULURU and shall not be required to purchase or accept any Product from ACCESS ULURU until and unless the Regulatory Shortfall has been remedied. In Within thirty (30) days of signing this agreement ULURU will provide ALTRAZEAL with a copy of the event that WYETH elects manufacturing batch records in sufficient details to manufacture enable ALTRAZEAL to produce the Product itself and/or qualify an alternative supplier should ULURU be in violation of the Product in accordance with provisions of this Section Article 2.6, then ACCESS shall reimburse WYETH for WYETH's reasonable additional cost in obtaining and establishing an alternative supplier.