Common use of Product Manufacture and Supply Clause in Contracts

Product Manufacture and Supply. 6.1 Within six (6) months of the Effective Date or such longer period as may otherwise be agreed in writing (including by email), the Parties shall agree a detailed Manufacturing and Supply Plan for the supply of the Drug Product through the JSC. The Manufacturing and Supply Plan shall be based on the following principles: 6.1.1 the Parties shall develop a detailed forecasting, supply, access and implementation plan for the supply of the Drug Product and define related operational supply chain management processes to ensure availability and access of the Drug Product in the Field with the consultation, as appropriate, of one or more funding agencies or partners, e.g., the World Health Organisation; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. 6.1.2 the Parties will use commercially reasonable endeavours to optimize production costs and will seek opportunities to jointly appoint Manufacturing Sublicensee(s) where possible; 6.1.3 the Parties will give due consideration to the need to ensure continued efficacy and responsible use of the Drug Product and will therefore seek to minimize the number of Sublicensees for Manufacturing; 6.1.4 if the appointment of joint Manufacturing Sublicensee(s) is not possible, each Party will have the right to Manufacture the Drug Product anywhere in the world (and subject to Clauses 7.6 and 7.8 appoint a Sublicensee to do so) and to Commercialise the Drug Product in the countries in its respective Territory for which a Marketing Authorization has been obtained; 6.1.5 each Party shall make reasonably available to nominated representatives of the other Party appropriate personnel to educate and train such representatives in relation to Know How that may be required to Manufacture the Drug Product; 6.1.6 each Party will ensure that any Drug Product is supplied with appropriate instructions for use and neither Party will promote the Drug Product for any use or indication other than those specified in the Marketing Authorisation in the Territory or part thereof from time to time or make any medical or promotional claims regarding the Drug Product other than permitted by law; 6.1.7 each Party will use commercially reasonable endeavours to ensure that the Drug Product is made available at price which is affordable and sustainable in its respective Territory and any part thereof; 6.1.8 the Drug Product manufactured for Commercialisation in the Entasis Territory shall be reasonably distinguished from the Drug Product for Commercialisation in the DNDi Territory, as agreed by Parties; 6.1.9 unless otherwise agreed each Party will be responsible for packaging and labelling of Drug Products in its Territory; 6.1.10 each Party shall be responsible for its own Promotional Materials for use in its Territory and for filing such Promotional Materials with the relevant Drug Regulatory Authority as required; 6.1.11 each Party (or its Sublicensee) shall use its own name and/or logo for Commercialisation in its Territory unless otherwise agreed. 6.2 DNDi will promptly notify Entasis in accordance with the Development Plan if DNDi, either itself or through an Affiliate or a Third Party on its behalf, improves, modifies, or enhances the formulation of the Drug Product; 6.3 It is acknowledged that Entasis has certain obligations to make milestone payments to Astra Zeneca AB (and/or its affiliates) in relation to the API (“Astra Zeneca”). The Parties agree that any such payments to Astra Zeneca will be paid in full by Entasis and that such costs shall not be transferred to DNDi (and/or any of its Sublicensee(s)) whether directly or indirectly or applied to the costs of any supply of Drug Product for Commercialisation in the DNDi Territory. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

Product Manufacture and Supply. 6.1 Within 5.1 During the term of this Agreement, Medicis shall purchase or otherwise obtain exclusively from Ipsen or from any Affiliate or Third Party appointed by Ipsen, all of the Product requirements for the Products Medicis, its Affiliates, or appointed distributors distribute under this Agreement. 5.2 Ipsen shall use commercially reasonable efforts to manufacture or have manufactured and deliver to Medicis clinical batches of Current Product and agreed future Products which are the subject of a Development and Regulatory Program, in those quantities indicated by Medicis to Ipsen prior to the Effective Date and further agreed by the Review Committee as reasonably sufficient to enable Medicis to perform the Development and Regulatory Program, according to instructions received with reasonable notice from the Review Committee. The agreed quantities of clinical trial supplies of Current Product will be provided by Ipsen without cost to Medicis. 5.3 Ipsen shall use commercially reasonable efforts to ensure that each clinical batch and marketing batch of the Current Product shall be manufactured in conformity with the specifications attached in Appendix 1 as existing at the Effective Date or as modified pursuant to a change required under applicable regulations or by the Review Committee. Such changes shall be notified to Medicis prior to implementation. Ipsen shall use commercially reasonable efforts not to delay the delivery of clinical or marketing batches of Current Product so that any such changes do not affect the delivery thereof to Medicis. Ipsen shall use commercially reasonable efforts to ensure that each clinical batch or marketing batch of any future agreed Products be manufactured in conformity with agreed specifications. 5.4 Ipsen shall use commercially reasonable efforts to supply Medicis or its designees with all such ordered quantities of marketing batches of Products in a timely manner as follows: - Products shall be delivered in a finished, packed and labeled form as agreed between the parties taking into account applicable regulatory constraints in the United Kingdom and in the Territory; - Conditions of sales shall be CIP (Carriage and Insurance Paid - Incoterms 2000 of International Chamber of Commerce), at one of Medicis's principal distribution points within each of the three countries of the Territory, which distribution points shall be reasonably agreed upon by the parties. - Ipsen will use commercially reasonable efforts to deliver Products to Medicis as promptly as possible with as much shelf life remaining as possible. Ipsen shall provide Medicis with the regulatory content which shall appear on packaging materials for the Products, and with the packaging materials format and specifications, in order (by way of example) for Medicis to conceive the artwork for the packaging materials for the Products, including but not limited to outer and inner packaging, leaflets and labels. Medicis shall start working on said artwork for the Products forthwith as from receipt of the regulatory content provided by Ipsen, without prejudice to final changes to the artwork which Medicis shall implement on the basis of the final regulatory content as shall be determined by the corresponding Regulatory Approvals in the Territory. The artwork conceived by Medicis shall be consistent with the Specifications set forth in Appendix 1 hereof with respect to the Current Product, and with the packaging materials format and specifications provided by Ipsen. In particular, Medicis shall make commercially reasonable efforts to use artwork tools and software compatible with Xxxxx'x technical standards concerning pre-printed packaging components. Ipsen shall inform Medicis of such standards. Medicis shall provide Ipsen with all the artwork, including the layouts and films (if possible on disc), relating to the Products packaging materials for Ipsen to pack the Product into final saleable form. The packaging materials for the Products conceived by Medicis shall include all the applicable regulatory contents provided by Ipsen, subject to changes required by the Regulatory Approvals issued in the Territory. Medicis and Ipsen shall each provide the other with appropriate and updated information related to the legal and regulatory requirements in the Territory with regards to the Products (including but not limited to quality, therapeutic use, packaging, labeling and storage). Such information shall be forwarded by one party to the other forthwith upon its becoming aware of the same. Final decision on whether to proceed to the regulatory modification of the content of any of the Products packaging materials, including all Product labels, shall be vested exclusively in Ipsen subject to Medicis's reasonable objection in writing to the proposed modification, within reasonable time. All Products sales boxes and leaflets shall bear the mentions referred to in Article 8.8(iii). 5.5 Medicis shall provide warehouse facilities in the Territory adequate to store the Products in accordance with the relevant prescriptions of the Specifications and with standard requirements related to pharmaceutical products storage and handling. 5.6 For Xxxxx manufacturing operations planning purposes only of clinical batches and marketing batches of the Current Product and agreed future Products, Medicis will use commercially reasonable efforts to provide Ipsen with 5.6.1 a thirty six month rolling order forecast updated and complemented by an additional six month forecast simultaneously with the placing of each semester binding offer, 5.6.2 a rolling twelve-month order forecasts updated and complemented each month by an additional monthly forecast, and 5.6.3 a firm order for clinical batches and marketing batches of the Current Product and agreed future Products that shall cover a period of six months and which shall provide for delivery dates. Ipsen shall use commercially reasonable efforts so as to meet the requested delivery dates; provided however that should any of Medicis's firm purchase orders for the Product differ by more than ten percent (10%) from the quantities appearing in the applicable rolling forecast, Ipsen will not be responsible in case of delays in the delivery of excess quantities. Detailed procedure as to such forecast and ordering processes is set forth in the technical agreement referred to in Article 5.14 hereof. 5.7 In consideration for the supply of the Current Products by Ipsen to Medicis, Medicis shall pay to Ipsen the price set forth in Appendix 8 hereto or as later determined as a result of the following Article 5.7 and as a result of Article 6.4. Such prices are based on *** units of toxin activity per vial, being functionally equivalent to approximately ***units of the competing product of the Current Product (Botox(R) by Allergan) as such competing product exists at the Effective Date. Without prejudice to either party's right to seek price adjustment under and in accordance with Article 6.4, in the event that, through the dose ranging studies which Medicis shall perform under the Development and Regulatory Program, and to the extent further analysis reveals that the functional equivalent of the Current Product and of its competing formulation as at the Effective Date is not 3:1, the prices set forth in Appendix 8 hereto will be adjusted proportionately, either up or down. Agreed quantities of promotional marketing samples will be provided by Ipsen to Medicis at a fixed price set forth in Appendix 8 (and without royalty nor inclusion in Net Sales) for Medicis's use for promotional purposes. 5.8 In case of Product shortage resulting in Product supplies insufficient to fill both Xxxxx'x world-wide sales requirements and Medicis's requirements for Products for the Territory, whether as a consequence of force majeure or any other cause, Ipsen and Medicis will each receive a pro rata share, based on the relative proportion of the last six (6) months of Xxxxx'x world-wide sales to Medicis's Product sales in the Effective Date Territory, each expressed in number of vials, of available quantities of Product for as long as the shortage lasts. Ipsen will use its commercially reasonable efforts at all times to supply Medicis with enough Product for Medicis to maintain a safety stock corresponding to Medicis's Product sales in the Territory during the three (3) months preceding any Product delivery. Medicis undertakes to permanently hold such three-month safety stock unless such safety stock cannot be constituted owing to Xxxxx'x failure to supply Products in sufficient quantities. In the event of complete stock-out in a country of the Territory, except in case of force majeure and provided Medicis previously complied with its obligation to maintain a three-month safety stock, for each five (5) business days of stock out, Medicis shall receive a credit towards future royalties in an amount equal to *** percent (***%) of the royalties accrued over the last four (4) weeks Medicis was able to fully supply the market in the concerned country of the Territory. 5.9 Ipsen covenants with Medicis that: - Ipsen shall use commercially reasonable efforts to manufacture the Products in accordance with cGMP regulations, if applicable, or in accordance with applicable law and regulations in the case of samples of Product supplied for use in the Development and Regulatory Program; - the Products shall be manufactured to meet the specifications therefor submitted to any regulatory authority having jurisdiction over such longer period Products in the Territory and to be of satisfactory quality as may otherwise be agreed specified in the applicable Regulatory Approval. 5.10 Ipsen shall, with each delivery of Product to Medicis, supply a certificate of analysis related to each batch delivered and a signed statement that each such batch conforms with the Specifications and accords in all other respects with the relevant Regulatory Approvals in the Territory, that the Product meets all stability requirements and that the manufacturing procedures have been checked in conformity with cGMP or, in the case of samples of the Products supplied for use in the Development and Regulatory Program, in conformity with applicable law. 5.11 Medicis shall notify Ipsen of any defective material or workmanship of the Product in writing as follows: - claims in respect of visible nonconformity shall be made within fifteen (including by email), the Parties shall agree a detailed Manufacturing and Supply Plan for the supply 15) days after arrival of the Drug Product through the JSC. The Manufacturing and Supply Plan concerned Products at Medicis's principal distribution points, - claims in respect of any hidden nonconformity shall be based on the following principles: 6.1.1 the Parties shall develop a detailed forecasting, supply, access and implementation plan for the supply made within thirty (30) days after Medicis became aware of the Drug Product and define related operational supply chain management processes to ensure availability and access same, - defects which could involve product liability for Ipsen, Medicis, or any of their Affiliates or distributors, shall be notified promptly upon becoming aware of the Drug Product in the Field with the consultationsame, as appropriate, of one or more funding agencies or partners, e.g., the World Health Organisation; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant - Third Party claims relating to Rule 406 product liability matters shall be notified promptly upon becoming aware of the Securities Act of 1933, as amendedsame. 6.1.2 5.12 In the Parties event of any claim with respect to the quality of the Product or its conformity to the Specifications which is not due to events that occurred after delivery of the Product by Ipsen to the first carrier, Ipsen will use commercially reasonable endeavours efforts to optimize production costs make available to Medicis the necessary quantity of samples of the defective/non-conforming Product together with Xxxxx'x own certificate of analysis and, if requested by either party, the unsold quantities of the concerned batch of defective Product and will seek opportunities said samples, shall be retained intact for inspection by the other party or any agent appointed by such party to jointly appoint Manufacturing Sublicensee(s) where possible; 6.1.3 which the Parties will give due consideration other party has made no reasonable objection. In case of non-conformity to the need to ensure continued efficacy and responsible use Specifications of any quantity of the Drug Product and will therefore seek delivered to minimize the number of Sublicensees for Manufacturing; 6.1.4 if the appointment of joint Manufacturing Sublicensee(s) Medicis which is not possibledue to events that occurred after delivery of the Product by Ipsen to the first carrier, each Party will have Ipsen shall take back, at its own expense, the right quantities concerned and shall replace them as soon as commercially practicable so as to Manufacture the Drug Product anywhere avoid any disruption of supply in the world (and subject Territory. If Ipsen does not replace any non-conforming quantities of Product promptly, Ipsen shall promptly refund the price paid by Medicis in respect of such quantities. Any dispute between the parties regarding the conformity to Clauses 7.6 and 7.8 appoint a Sublicensee to do so) and to Commercialise the Drug Product in the countries in its respective Territory for which a Marketing Authorization has been obtained; 6.1.5 each Party shall make reasonably available to nominated representatives Specifications of any quantity of the other Party appropriate personnel to educate and train such representatives in relation to Know How that may be required to Manufacture the Drug Product; 6.1.6 each Party will ensure that any Drug Product is supplied with appropriate instructions for use and neither Party will promote the Drug Product for any use or indication other than those specified in the Marketing Authorisation in the Territory or part thereof from time to time or make any medical or promotional claims regarding the Drug Product other than permitted by law; 6.1.7 each Party will use commercially reasonable endeavours to ensure that the Drug Product is made available at price which is affordable and sustainable in its respective Territory and any part thereof; 6.1.8 the Drug Product manufactured for Commercialisation in the Entasis Territory delivered hereunder shall be reasonably distinguished from the Drug Product for Commercialisation in the DNDi Territory, as agreed by Parties; 6.1.9 unless otherwise agreed each Party will be responsible for packaging and labelling of Drug Products in its Territory; 6.1.10 each Party shall be responsible for its own Promotional Materials for use in its Territory and for filing such Promotional Materials with the relevant Drug Regulatory Authority as required; 6.1.11 each Party (or its Sublicensee) shall use its own name and/or logo for Commercialisation in its Territory unless otherwise agreed. 6.2 DNDi will promptly notify Entasis resolved in accordance with the Development Plan if DNDi, dispute resolution procedures set forth in the technical agreement referred to in Articles 5.14 of this Agreement. 5.13 In the event either itself party has reason to believe that one or through an Affiliate or a Third Party on its behalf, improves, modifiesmore batch(es) of Product supplied hereunder should be recalled from distribution in the Territory, or enhances that any Product supplied hereunder should be withdrawn from the formulation Territory, such party shall promptly inform the other in writing. Upon Xxxxx'x reasonable request, Medicis shall implement any Product batch recall or Product withdrawal from the Territory in accordance with the applicable procedure as shall be agreed under Article 11. 5.14 A technical agreement covering all technical, quality and logistical aspects of manufacturing for the supply by Ipsen to Medicis of the Drug necessary quantities of Current Product and any other agreed Products, shall be agreed as soon as practical and no later than one hundred and twenty (120) days after the Effective Date. With regards to clinical trial supplies of Current Product; 6.3 It is acknowledged that Entasis has certain obligations , the technical agreement shall be agreed upon between the parties as soon as possible after the Effective Date. All such technical agreements will detail a change control policy with the obligation to make milestone payments communicate prior to Astra Zeneca AB (and/or its affiliates) in relation to the API (“Astra Zeneca”). The Parties agree that implementation any such payments to Astra Zeneca will be paid in full by Entasis and that such costs shall not be transferred to DNDi (and/or any of its Sublicensee(s)) whether directly or indirectly or applied to the costs of any supply of Drug Product for Commercialisation planned changes in the DNDi Territory. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 manufacturing of the Securities Act of 1933Product. On reasonable notice to Ipsen and subject to any obligations owed or limitations on access agreed to with any Third Parties, as amendedIpsen shall xxxxx Xxxxxxx and its authorized representatives reasonable access to Xxxxx'x present and future manufacturing facilities in order to inspect and evaluate Xxxxx'x facilities for Current Product and any other agreed Products in order to satisfy any regulatory requirements or requests.

Product Manufacture and Supply. 6.1 Within six (6) months of the Effective Date or such longer period as may otherwise be agreed in writing (including by email), the Parties shall agree a detailed Manufacturing and Supply Plan for the supply of the Drug Product through the JSC. The Manufacturing and Supply Plan shall be based on the following principles: 6.1.1 the Parties shall develop a detailed forecasting, supply, access and implementation plan for the supply of the Drug Product and define related operational supply chain management processes to ensure availability and access of the Drug Product in the Field with the consultation, as appropriate, of one or more funding agencies or partners, e.g., the World Health Organisation; 12 | Page [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. 6.1.2 the Parties will use commercially reasonable endeavours to optimize production costs and will seek opportunities to jointly appoint Manufacturing Sublicensee(s) where possible; 6.1.3 the Parties will give due consideration to the need to ensure continued efficacy and responsible use of the Drug Product and will therefore seek to minimize the number of Sublicensees for Manufacturing; 6.1.4 if the appointment of joint Manufacturing Sublicensee(s) is not possible, each Party will have the right to Manufacture the Drug Product anywhere in the world (and subject to Clauses 7.6 and 7.8 appoint a Sublicensee to do so) and to Commercialise the Drug Product in the countries in its respective Territory for which a Marketing Authorization has been obtained; 6.1.5 each Party shall make reasonably available to nominated representatives of the other Party appropriate personnel to educate and train such representatives in relation to Know How that may be required to Manufacture the Drug Product; 6.1.6 each Party will ensure that any Drug Product is supplied with appropriate instructions for use and neither Party will promote the Drug Product for any use or indication other than those specified in the Marketing Authorisation in the Territory or part thereof from time to time or make any medical or promotional claims regarding the Drug Product other than permitted by law; 6.1.7 each Party will use commercially reasonable endeavours to ensure that the Drug Product is made available at price which is affordable and sustainable in its respective Territory and any part thereof; 6.1.8 the Drug Product manufactured for Commercialisation in the Entasis Territory shall be reasonably distinguished from the Drug Product for Commercialisation in the DNDi Territory, as agreed by Parties; 6.1.9 unless otherwise agreed each Party will be responsible for packaging and labelling of Drug Products in its Territory; 6.1.10 each Party shall be responsible for its own Promotional Materials for use in its Territory and for filing such Promotional Materials with the relevant Drug Regulatory Authority as required; 6.1.11 each Party (or its Sublicensee) shall use its own name and/or logo for Commercialisation in its Territory unless otherwise agreed. 6.2 DNDi will promptly notify Entasis in accordance with the Development Plan if DNDi, either itself or through an Affiliate or a Third Party on its behalf, improves, modifies, or enhances the formulation of the Drug Product; 6.3 It is acknowledged that Entasis has certain obligations to make milestone payments to Astra Zeneca AB (and/or its affiliates) in relation to the API (“Astra Zeneca”). The Parties agree that any such payments to Astra Zeneca will be paid in full by Entasis and that such costs shall not be transferred to DNDi (and/or any of its Sublicensee(s)) whether directly or indirectly or applied to the costs of any supply of Drug Product for Commercialisation in the DNDi Territory. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.