前回の続きです。具体的に委託先に主要原料を引き渡す手順、渡した後の製造、製品の引き渡し、価格設定、製造責任、検査、委託先工場監査などの条項を書くことになります。
Article 4 Shipment and Delivery of X’s Raw Materials
4.1 Before shipment to Y, X’s Raw Materials shall be inspected by X’s Raw Materials Supplier under all specified and applicable standard(s) of X’s Raw Materials Supplier’s designated Quality Control department. Upon delivery to Y, X’s Raw Materials Supplier will provide the corresponding inspection certificate to Y. (委託元が主要原料を委託先に出荷する場合には)、当然検査に合格したものでその証明書を委託先に交付する必要がありますね）
4.2 X will arrange all necessary and applicable transportation of X’s Raw Materials to the specified facility of Y. Once arranged by X with the designated carrier, X will inform Y of the estimated date of arrival of X’s Raw Material, recognizing however that X cannot commit to the specific date of delivery to the specified facility of Y. Consequently, Y will have to manage its own production schedule to fulfill a specific Contract Work Order in accordance with (i) its managed inventory, and (ii) final delivery of X Raw Material.
4.3 Upon receipt of X’s Raw Materials, Y shall inspect the quantity, quality and the specification of the delivered shipment. In the event of either (i) a weight shortage or excess, or (ii) a defect in quality or nonconformity to applicable specification(s) is discovered by Y as a result of inspection of the delivered X Raw Materials, Y shall notify X thereof with all supporting documentation certifying such claim(s) within ten (10) days of arrival of X’s Raw Materials at Y. （受託者が委託者から供給を受けた原料は、受領検査をします。塩濡れ、梱包破損等などもありますし、アメリカではあまりありませんが、シベリア鉄道で欧州などに輸送する場合は、「抜け荷」などで窃取される恐れもありますね。）
この後は、送り主の情報と齟齬があるにも拘らず、通知を怠った場合の事なども記載するのですが、長くなりますのでカットします。
4.4 In case X has received a notice of defect in quality or unconformity from Y in accordance with paragraph 4.3 of this Article, X shall instruct Y to take any appropriate and necessary step(s) as soon as possible.
4.5 Within thirty (30) days after Y’s confirmed receipt of X’s Raw Materials, X shall issue an invoice to Y for the associated delivered goods and Y shall remit payment to the designated X’s account within sixty (60) days of the specified invoice date. 原料受領後30日以内に、受託者に有償支給原料の請求書を発行と記載していますが、受託者が製造して委託者に製品を販売し、その請求書のDue Dateと合わせると、受託者の資金繰り上は楽ですね。
Article 5 Production of the Products
5.1 The Products shall be manufactured, tested, packaged and labelled in accordance with (i) the Specifications, (ii) all applicable laws of Y’s country, and (iii) best manufacturing practices as firmly established and prevalent within the industry.
5.2 All manufacturing, testing, packaging and labelling of the Products shall be conducted by Y in a clean and sanitary environment. Y asserts that it has all appropriate procedures in place to assure that (i) Product labels are in conformity with applicable requirements and (ii) that the correct label is applied to each Product.
5.3 Y will take all the necessary and preventive measures to avoid any cross contamination of the Products with any other product for health safety and qualitative reasons.
5.4 Packaging and Labeling for the Products and Pallet requirement are mentioned in the Appendix A are subject to change. Y shall be responsible for ensuring the Product’s compliance with the labeling requirements of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) and other applicable US Federal and State food labeling laws and regulations. Y, on behalf of X, will apply for and obtain UPC (Universal Product Codes) required for labeling of the Products, all associated and documented costs incurred being reimbursed to Y by X.（米国企業へ製造委託する場合で、連邦食品医薬品化粧品法の順守を規定していますが、米国では州の法律もありますので、それも記載しないといけないですが、そこまではわからないので書いていません。食品医薬品化粧品等は、専門のコンサルティング会社がありますので、そういった会社に聞くことも有益ですが、そこは聞いてもわからないこともおおいので、次の5.5に書いているような一般的な書き方で逃げる場合もあります）
5.5 At the time of shipment and/or delivery to X (or any designated consignee), all Products manufactured, tested, packaged and labelled pursuant to this Agreement (i) shall not be adulterated, contaminated, or misbranded within the meaning of the FD&C Act (as amended) or any other US Federal, State, or local law, rule, or regulation, and (ii) that such Products, packaging and other materials shall not constitute articles prohibited from introduction into interstate commerce under the provisions of Sections 301, 402, 403, 404, 405, 409, or 505 of the FD&C Act. Y also specifically warrants that it will register and fully comply with all applicable requirements under the Bioterrorism Act and the FDA's implementing regulations.
委託者が要求する場合には、当局の検査に合格している合格証の写しなどを委託者に提出する。また、定期的にQCレポート等の提出。製品の消費期限＋ｘか月間の製造ロットごとの製品サンプルの保管。委託者の受託者の工場視察等の条項を入れます。
また、製造記録のｘ年間の保管義務、その記録の閲覧コピー権なども規定します。
Article 6 Delivery of the Products （製品の委託者への引渡の条項で、委託者の引取義務を規定します）
6.1 X shall take delivery of each Packaged Products under the trade terms of F.O.B. Y’s production facility (Trade terms of Uniform Commercial Code are applied in this Agreement). Y (i) will arrange domestic transportation at X’s expense and (ii) assumes the cost and risk of loading trucks at Y on the scheduled date scheduled for shipment, or such other date agreed upon by the parties in writing (including E-mail). 引渡はIncotermsの条件ではないですね。
6.2 Time of delivery to X will be indicated on the Contract Work Order.
6.3 Each delivery shall be accompanied by the delivery note, on which Y shall indicate:
-Number of the Contract Work Order, /-Name of the Product,/-X’s product reference,/-The (Y) batch number,/-Type of package,/-The gross and net weights, and analysis certificate 等の明細を記載します。
The above delivery note and analysis certificate shall be also submitted to X together with Y’s invoice to X.
上記に続いて、製品が契約通りの仕様に基づいていない場合や納期遅延の対処方法なども規定します。
Article 7 Pricing and Payment Terms
7.1 The following will apply during the term of this Agreement, unless otherwise agreed or mentioned in each Contract Work Order.
(1) Y shall sell the Product to X at the price specified in the Appendix C, based F.O.B. Y’s production facility, exclusive of value added tax or any other taxes imposed on the purchase and sale of the Product.
(2) Y’s invoices for the Contract Work Orders are payable by X within thirty (30) days of Y’s invoice date.
7.2 Title to the Products will change at such time Y completes loading the Products on the delivery truck at Y’s designated facility.
Article 8 Liability (この製造責任の規定は、米国では必ず入る重要な規定だと思います)
Y shall be responsible for (i) any bodily harm, (ii) tangible and/or intangible damage it has directly caused through its fault or negligence (or more generally through its non-compliance with its contractual obligations), to anyone and amongst others, to X or its employees, as well as any damage or prejudice caused by its personnel or by persons acting on its behalf and arising out of the execution of this Agreement
Y shall indemnify, defend and hold X and its present and future officers, directors, employees, agents, affiliates, successors and assigns harmless from and against any and all claims, causes of action, demand, damages, judgments, liabilities, actions, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees) of whatever nature (collectively “Losses”) arising out of or related in any way to: (a) any breaches by Y of this Agreement; or (b) any misrepresentation, any negligent or wrongful act or omission, of Y.
Y asserts that it will maintain through the term ended three (3) years beyond the expiration of this Agreement third-party insurance coverage (through a AAA rated insurance carrier or of similar credit quality) insurance coverage for professional liability related to bodily harm, tangible and intangible damages arising out of its direct and/or indirect activity for up to US$2 Million per incident, not to exceed US$20 Million in with any one claimant.
Upon its signing of this Agreement, Y shall forward to X a copy of its insurance certificate for the risks and term outlined in this Article. Should this Agreement be renewed under the terms set forth in Article xx hereunder, Y shall prove to X that the above mentioned insurance has been extended or otherwise established with a new, third-party insurance carrier for the new contractual period of this Agreement.
Article 9 Audit
Y shall maintain, retain, and make available to as reasonably requested by X for the purposes of third-party supplier audits, all standard operating procedures, quality assurance manufacturing records, batch production records and other records directly related to the production of the Products, as required by FDA or other applicable regulations. X shall have the right to review such records and the manufacturing operations used to manufacture the Products at Y's facilities during regular business hours and upon thirty (30) days advance written notice to Y for the sole purpose of auditing compliance by Y with the terms of this Agreement. (他に、Y側の事情があれば時期変更依頼ができるとか、Y側は、受け入れコストの請求は出来ない等の追加を入れる場合があります)
上記の他に、守秘義務、契約違反、損害賠償、不可抗力、契約期間、当事者の関係、準拠法、契約変更、紛争解決、契約の譲渡、Entire Agreement条項等を入れます。
今までの条項を見てお気づきかもしれませんが、本件は製造委託ですので、Specの指定は委託者がします。一般的な品質保証の規定は入っていません。米国の品質保証の規定については、20130615のBlog 「UCCのWarranty (品質保証)」https://blog.goo.ne.jp/masaru320/m/201306 をご覧ください。
Article 4 Shipment and Delivery of X’s Raw Materials
4.1 Before shipment to Y, X’s Raw Materials shall be inspected by X’s Raw Materials Supplier under all specified and applicable standard(s) of X’s Raw Materials Supplier’s designated Quality Control department. Upon delivery to Y, X’s Raw Materials Supplier will provide the corresponding inspection certificate to Y. (委託元が主要原料を委託先に出荷する場合には)、当然検査に合格したものでその証明書を委託先に交付する必要がありますね）
4.2 X will arrange all necessary and applicable transportation of X’s Raw Materials to the specified facility of Y. Once arranged by X with the designated carrier, X will inform Y of the estimated date of arrival of X’s Raw Material, recognizing however that X cannot commit to the specific date of delivery to the specified facility of Y. Consequently, Y will have to manage its own production schedule to fulfill a specific Contract Work Order in accordance with (i) its managed inventory, and (ii) final delivery of X Raw Material.
4.3 Upon receipt of X’s Raw Materials, Y shall inspect the quantity, quality and the specification of the delivered shipment. In the event of either (i) a weight shortage or excess, or (ii) a defect in quality or nonconformity to applicable specification(s) is discovered by Y as a result of inspection of the delivered X Raw Materials, Y shall notify X thereof with all supporting documentation certifying such claim(s) within ten (10) days of arrival of X’s Raw Materials at Y. （受託者が委託者から供給を受けた原料は、受領検査をします。塩濡れ、梱包破損等などもありますし、アメリカではあまりありませんが、シベリア鉄道で欧州などに輸送する場合は、「抜け荷」などで窃取される恐れもありますね。）
この後は、送り主の情報と齟齬があるにも拘らず、通知を怠った場合の事なども記載するのですが、長くなりますのでカットします。
4.4 In case X has received a notice of defect in quality or unconformity from Y in accordance with paragraph 4.3 of this Article, X shall instruct Y to take any appropriate and necessary step(s) as soon as possible.
4.5 Within thirty (30) days after Y’s confirmed receipt of X’s Raw Materials, X shall issue an invoice to Y for the associated delivered goods and Y shall remit payment to the designated X’s account within sixty (60) days of the specified invoice date. 原料受領後30日以内に、受託者に有償支給原料の請求書を発行と記載していますが、受託者が製造して委託者に製品を販売し、その請求書のDue Dateと合わせると、受託者の資金繰り上は楽ですね。
Article 5 Production of the Products
5.1 The Products shall be manufactured, tested, packaged and labelled in accordance with (i) the Specifications, (ii) all applicable laws of Y’s country, and (iii) best manufacturing practices as firmly established and prevalent within the industry.
5.2 All manufacturing, testing, packaging and labelling of the Products shall be conducted by Y in a clean and sanitary environment. Y asserts that it has all appropriate procedures in place to assure that (i) Product labels are in conformity with applicable requirements and (ii) that the correct label is applied to each Product.
5.3 Y will take all the necessary and preventive measures to avoid any cross contamination of the Products with any other product for health safety and qualitative reasons.
5.4 Packaging and Labeling for the Products and Pallet requirement are mentioned in the Appendix A are subject to change. Y shall be responsible for ensuring the Product’s compliance with the labeling requirements of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) and other applicable US Federal and State food labeling laws and regulations. Y, on behalf of X, will apply for and obtain UPC (Universal Product Codes) required for labeling of the Products, all associated and documented costs incurred being reimbursed to Y by X.（米国企業へ製造委託する場合で、連邦食品医薬品化粧品法の順守を規定していますが、米国では州の法律もありますので、それも記載しないといけないですが、そこまではわからないので書いていません。食品医薬品化粧品等は、専門のコンサルティング会社がありますので、そういった会社に聞くことも有益ですが、そこは聞いてもわからないこともおおいので、次の5.5に書いているような一般的な書き方で逃げる場合もあります）
5.5 At the time of shipment and/or delivery to X (or any designated consignee), all Products manufactured, tested, packaged and labelled pursuant to this Agreement (i) shall not be adulterated, contaminated, or misbranded within the meaning of the FD&C Act (as amended) or any other US Federal, State, or local law, rule, or regulation, and (ii) that such Products, packaging and other materials shall not constitute articles prohibited from introduction into interstate commerce under the provisions of Sections 301, 402, 403, 404, 405, 409, or 505 of the FD&C Act. Y also specifically warrants that it will register and fully comply with all applicable requirements under the Bioterrorism Act and the FDA's implementing regulations.
委託者が要求する場合には、当局の検査に合格している合格証の写しなどを委託者に提出する。また、定期的にQCレポート等の提出。製品の消費期限＋ｘか月間の製造ロットごとの製品サンプルの保管。委託者の受託者の工場視察等の条項を入れます。
また、製造記録のｘ年間の保管義務、その記録の閲覧コピー権なども規定します。
Article 6 Delivery of the Products （製品の委託者への引渡の条項で、委託者の引取義務を規定します）
6.1 X shall take delivery of each Packaged Products under the trade terms of F.O.B. Y’s production facility (Trade terms of Uniform Commercial Code are applied in this Agreement). Y (i) will arrange domestic transportation at X’s expense and (ii) assumes the cost and risk of loading trucks at Y on the scheduled date scheduled for shipment, or such other date agreed upon by the parties in writing (including E-mail). 引渡はIncotermsの条件ではないですね。
6.2 Time of delivery to X will be indicated on the Contract Work Order.
6.3 Each delivery shall be accompanied by the delivery note, on which Y shall indicate:
-Number of the Contract Work Order, /-Name of the Product,/-X’s product reference,/-The (Y) batch number,/-Type of package,/-The gross and net weights, and analysis certificate 等の明細を記載します。
The above delivery note and analysis certificate shall be also submitted to X together with Y’s invoice to X.
上記に続いて、製品が契約通りの仕様に基づいていない場合や納期遅延の対処方法なども規定します。
Article 7 Pricing and Payment Terms
7.1 The following will apply during the term of this Agreement, unless otherwise agreed or mentioned in each Contract Work Order.
(1) Y shall sell the Product to X at the price specified in the Appendix C, based F.O.B. Y’s production facility, exclusive of value added tax or any other taxes imposed on the purchase and sale of the Product.
(2) Y’s invoices for the Contract Work Orders are payable by X within thirty (30) days of Y’s invoice date.
7.2 Title to the Products will change at such time Y completes loading the Products on the delivery truck at Y’s designated facility.
Article 8 Liability (この製造責任の規定は、米国では必ず入る重要な規定だと思います)
Y shall be responsible for (i) any bodily harm, (ii) tangible and/or intangible damage it has directly caused through its fault or negligence (or more generally through its non-compliance with its contractual obligations), to anyone and amongst others, to X or its employees, as well as any damage or prejudice caused by its personnel or by persons acting on its behalf and arising out of the execution of this Agreement
Y shall indemnify, defend and hold X and its present and future officers, directors, employees, agents, affiliates, successors and assigns harmless from and against any and all claims, causes of action, demand, damages, judgments, liabilities, actions, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees) of whatever nature (collectively “Losses”) arising out of or related in any way to: (a) any breaches by Y of this Agreement; or (b) any misrepresentation, any negligent or wrongful act or omission, of Y.
Y asserts that it will maintain through the term ended three (3) years beyond the expiration of this Agreement third-party insurance coverage (through a AAA rated insurance carrier or of similar credit quality) insurance coverage for professional liability related to bodily harm, tangible and intangible damages arising out of its direct and/or indirect activity for up to US$2 Million per incident, not to exceed US$20 Million in with any one claimant.
Upon its signing of this Agreement, Y shall forward to X a copy of its insurance certificate for the risks and term outlined in this Article. Should this Agreement be renewed under the terms set forth in Article xx hereunder, Y shall prove to X that the above mentioned insurance has been extended or otherwise established with a new, third-party insurance carrier for the new contractual period of this Agreement.
Article 9 Audit
Y shall maintain, retain, and make available to as reasonably requested by X for the purposes of third-party supplier audits, all standard operating procedures, quality assurance manufacturing records, batch production records and other records directly related to the production of the Products, as required by FDA or other applicable regulations. X shall have the right to review such records and the manufacturing operations used to manufacture the Products at Y's facilities during regular business hours and upon thirty (30) days advance written notice to Y for the sole purpose of auditing compliance by Y with the terms of this Agreement. (他に、Y側の事情があれば時期変更依頼ができるとか、Y側は、受け入れコストの請求は出来ない等の追加を入れる場合があります)
上記の他に、守秘義務、契約違反、損害賠償、不可抗力、契約期間、当事者の関係、準拠法、契約変更、紛争解決、契約の譲渡、Entire Agreement条項等を入れます。
今までの条項を見てお気づきかもしれませんが、本件は製造委託ですので、Specの指定は委託者がします。一般的な品質保証の規定は入っていません。米国の品質保証の規定については、20130615のBlog 「UCCのWarranty (品質保証)」https://blog.goo.ne.jp/masaru320/m/201306 をご覧ください。
