1 THE UNIVERSITY OF DANANG UNIVESITY OF ECONOMICS REPORT BUSINESS NEGOTIATION ASSIGNMENT Group 4 Lecturer Nguyen Anh Tuan Members Nguyen Thi Kim Ngan Le Thi Bao Ngoc Vy Bao Ngoc Doan Nguyen Mi[.]
Build a Pre-Negotiation Process
The company's goals
The tangible objective of the enterprise is to reach agreement on quantity, product quality and price of pharmaceutical products imported from India to supply to the domestic market
Achieving the best import prices from Indian suppliers is a crucial negotiating goal, as it enables businesses to lower production costs and boost profits By securing competitive prices for raw materials while maintaining product quality, companies can effectively meet the demands of domestic customers.
To successfully import Indian pharmaceuticals, enterprises aim to identify strategic partners in India to enhance their business network and solidify partnerships This objective can be realized by forming trustworthy collaborations with suppliers, joint venture partners, or other organizations in India.
Strategic partnerships offer businesses valuable advantages such as access to local markets, resources, and expertise in navigating local laws and cultures By leveraging these benefits, companies can improve their competitiveness and expand their presence in the Indian market.
Building long-term and stable partnerships with Indian partners is crucial for businesses, as it enhances reliability and minimizes risks in transactions and collaborations within the Indian market.
When seeking strategic partners in India to enhance business networks and solidify partnerships, companies must address key contractual issues to ensure the successful achievement of their objectives.
Identify key issues
To successfully import pharmaceutical products from India and supply the domestic market, several key issues have been prioritized based on their tangible goals.
Negotiating a fair price for pharmaceutical products is essential, and the contract must clearly outline the price along with associated costs such as transportation, packaging, and insurance.
Shipping costs must be mutually agreed upon by the parties involved, covering the transportation of the product from the factory to the customer's location This agreement is essential for selecting the appropriate Incoterms, which define the responsibilities of each party.
Price: This is the most important issue in contract negotiation, the parties need to agree on a product price in accordance with the product's quality and competition in the market
Determining the price application time in a contract is essential for both parties, as it prevents fluctuations in product pricing during the contract's execution.
The contract must clearly outline the precise quantity of pharmaceutical products required for import from India to satisfy the needs of the domestic market.
The contract must clearly outline the delivery timeline for products shipped from India to the business's warehouse in Vietnam, ensuring timely availability for market distribution.
When establishing a contract, it is essential for both parties to agree on a delivery time that aligns with the customer's requirements The delivery timeframe should be explicitly defined to avoid any misunderstandings.
When shipping products, it is essential for the parties involved to establish specific shipping conditions, including temperature, humidity, light exposure, and other requirements, to prevent any damage during transportation.
Payment terms: The contract should clearly define the payment terms, such as prepayment, payment upon receipt, or payment by letter of credit
When deciding on a payment method for a product or service, parties should consider options such as bank transfer, credit card, cash, or other payment forms It is essential to select a payment method that aligns with the business environment and complies with relevant payment regulations in the sector.
When transferring funds for payments, it is essential for the involved parties to determine who will bear the remittance costs These expenses can encompass remittance fees, currency conversion charges, and other associated costs linked to moving money across international borders.
Shipping conditions: The contract should define the shipping conditions of the products from India to the business's warehouse in Vietnam, including the shipping method, transit time, and shipping costs
The contract must clearly define the responsibilities of all parties in managing product quality, including the implementation of quality control procedures throughout the importation and supply chain process.
Disagreements between parties may arise regarding the applicable regulations and testing standards for goods, encompassing aspects such as testing methods, sample sizes, acceptance criteria, and other product testing requirements Additionally, these agreements can involve the reliability and recognition of the testing entities Conflicts may also occur concerning error handling procedures, compensation for damages, and the need for retesting.
Testing methods: The parties need to make a decision on the testing method for the product This method must meet quality standards and be executed properly
Determining responsibility and cost allocation for product testing is a critical issue Parties involved can propose terms for cost-sharing and ensure that the designated responsible party conducts testing in compliance with agreed-upon standards and regulations.
The warranty conditions outlined in the contract must clearly define the warranty period and terms, including the methods for returns or refunds Disputes may arise when the seller contests the warranty duration and its coverage, which encompasses specific components, parts, or services Additionally, the warranty's validity can be influenced by factors such as improper use, unauthorized repairs, or failure to adhere to usage instructions.
Disagreements regarding the warranty's scope and compensation methods can arise between parties It is essential to establish the value and extent of compensation, as well as the terms and conditions for resolving any damages that occur during the warranty period.
Identify the benefits, BATNAS, resistance points of several issues
Position (Needs): Reduce product cost per unit by 5%
Reduce production costs for the company (buy input from partners for production)
The negotiation process is shortened because the company is in urgent need of raw materials
The company's resistance point for reducing product costs is set at 0%, as the primary objective is to achieve integration through negotiation If price negotiations with the partner prove unsuccessful, the company can implement the logroll method This resistance point allows for flexibility, ensuring that both parties can maximize their benefits.
Offer to raise the minimum purchase amount, which means an increase in the number of purchases, at a lower price
Look for an alternative partner
Sun Pharmaceutical Industrial Company provides API with the price of the first
The company offers four products that meet our needs, but one essential product is not included in their business items While this alternative provides a reasonable price, it requires negotiating the purchase twice when collaborating with the company.
Dr Reddy provides all five API products at competitive prices that align with our requirements; however, their current production scale is insufficient to meet our purchasing volume It is crucial for the company to expand its production capacity, as there is an urgent need for raw materials.
3.2 About the timing of the price increase:
Needs: Only make product price increases every 6 months
Interest: Helps stabilize costs for the company in the longer term (unless market prices drop)
Resistance Point: Performed every 3 months the price move up
Needs: 30 - 60 days from the date of receiving the product
Interest: Allowing buyers enough time to check the quality of the product before paying the seller
The resistance point for returns is set at 20 days from the product receipt date It is essential that payment terms are not overly brief, as businesses require sufficient time to deplete existing stock before new shipments arrive.
Interest: Helps to reduce payment risks, ensure the quality and quantity of goods as well as help control costs for buyers
Payment by receipt of documents is a secure method, as buyers only pay sellers upon receiving complete and accurate documentation However, it is less secure than a letter of credit, since if the seller does not fulfill the documentation requirements, the buyer cannot proceed with the payment.
Payment through a bank guarantee is not advisable, as sellers receive payment only upon meeting specific guarantee conditions This method does not protect buyers; if the seller defaults on their obligations, the buyer remains liable to pay the bank.
Partner analysis
Divi is a leading Indian multinational pharmaceutical company renowned for its high-quality production of active pharmaceutical ingredients (APIs), intermediates, and nutritional ingredients As a global leader in API manufacturing, Divi stands out among the top pharmaceutical companies, offering exceptional quality that enhances its negotiating power in the market.
Demand: Sell their pharmaceutical products at the advertised price
Selling at the optimal price can significantly boost a business's revenue For negotiators, achieving a successful deal often feels like a victory over their counterpart, as they typically approach negotiations with a competitive mindset.
The partner's resistance point is likely to be high, near the announced selling price of 7%, as they prefer a split negotiation to maximize their benefits Therefore, it is crucial not to offer a price that is too low, as this could lead to them withdrawing from the negotiation.
Understanding the competitors' Best Alternative to a Negotiated Agreement (BATNAs) poses a challenge for us, as we are new to this market and have limited access to our partner's client information Additionally, given that this is an international company with a vast customer base, accurately assessing their BATNAs is particularly difficult.
The primary objective of the partner company is to boost sales and foster growth To accomplish this, the company emphasizes the development of new products, the enhancement of existing product quality, effective brand promotion, market expansion, and the maintenance of strong customer relationships.
Initial proposal: After having the first meeting with the partner, the two sides had discussions about the product as well as the product price
Table 1: API unit price of Divi
Composition and structure of the partner's negotiating team
Lead Negotiator: The person who represents the Indian side in the negotiation process The main negotiator is the person with high authority in the purchasing department, the purchasing manager
The Supporting Negotiator Team is composed of individuals with specialized expertise and skills who aid the lead negotiator during the negotiation process This team may include business experts, lawyers, translators, and technical support staff, all contributing to a more effective negotiation outcome.
Reputation and negotiating style of partners
In large-scale and professional negotiations, Indian partners prioritize prestige and mutual trust between both parties They emphasize the importance of keeping promises and fulfilling commitments to achieve a successful agreement.
In negotiations, the opposing party typically exhibits a rigid approach, consistently maintaining their perspective They communicate their requests and suggestions with clarity and firmness, making it challenging to alter their stance.
Strategies and tactics that partners often use
They make it their goal to get the highest possible benefit in the contract or agreement
To reach their objectives, negotiators typically utilize strategies that involve persuading their counterpart of the importance of their desired terms and identifying weaknesses in the opposing offer They emphasize collaboration and leverage these insights to secure a more favorable agreement Additionally, they often ask questions to uncover the partner's goals and needs, which helps in formulating an effective negotiation strategy.
Partners typically prefer to maintain independence during negotiations, resisting outside interference They prioritize self-responsibility and self-determination while also advocating for fairness and integrity Agreements that lack transparency or raise ethical concerns are often rejected by them.
Set your goal and suggest an opening
Successful negotiation with 6% discount for each product unit
The time to increase prices for product units is every 9 months
Price increase period is every 6 months
Assess the social context of the negotiation
The main representative of the buyer: The director of the purchasing department, who represents the buyer in the negotiation process
Buyer's Support Negotiating Team: Similar to the Indian counterpart's support negotiation team, this team consists of people with specific skills and expertise to assist the main buyer's representative
Negotiating for the first time with a company partner can be challenging, especially when there is no prior business relationship The lack of familiarity and the limited time spent together can lead to an unstable relationship, increasing the potential for issues arising from cultural differences.
Currently, both parties have had limited interaction, having only met to discuss fundamental topics like product presentation and pricing They are now prepared to engage in negotiations on more significant matters.
Embracing Indian culture, which values long-term relationships, the company has allocated additional time for the negotiation process to ensure it proceeds smoothly and securely, allowing for more detailed discussions.
Differences in culture, language, law, politics
Vietnam and India are two countries with different cultures, languages, laws, and politics Here are some notable differences:
Vietnam and India showcase distinct cultural identities, with Vietnam embodying an oriental culture and India reflecting a Hindu culture The values, practices, and customs in these countries differ significantly In Vietnam, there is a strong emphasis on respect for family, religion, age, and high civilization Conversely, Indian culture places great importance on respect for religion, family, customs, and cultural heritage.
Vietnam and India primarily communicate in Vietnamese and Hindi, respectively Vietnamese employs the Latin alphabet, whereas Hindi utilizes the Devanagari script Additionally, English serves as a common language for commerce and business in both nations.
Vietnam and India each possess distinct legal systems, with notable differences between them The civil and criminal laws in India diverge significantly from those in Vietnam, particularly concerning property rights and human rights issues.
Politics: Both Vietnam and India are republics However, India has a more complex political system than Vietnam, with many political divisions and parties
In terms of customs and standards, Vietnam and India have many differences In
In Vietnam, valuing age and family plays a crucial role in social interactions, whereas in India, the emphasis lies on respecting religion and social status These cultural differences significantly influence communication styles and interpersonal relationships in both nations.
India is characterized by its ancient cultural values, which include a deep respect for tradition and family, tolerance, openness, and a commitment to polite and solemn communication In contrast, Vietnam boasts its own unique cultural values, emphasizing respect for tradition, artistic ingenuity, hospitality, solidarity, sincerity, and honesty.
Overall, the cultural differences between Vietnam and India are very diverse and complex, which should be kept in mind during the negotiation and communication process between the two companies
The customs, standards, ethical aspects,
Vietnam and India, with their distinct cultures and historical development, exhibit significant differences in customs, standards, and ethical values.
Vietnam and India exhibit distinct customs, particularly in dietary practices and religious traditions In India, vegetarianism is widely respected and commonly practiced, whereas in Vietnam, it is less prevalent Additionally, India boasts a diverse array of religious rituals, while Vietnam is known for its unique folk traditions, including temple and pagoda festivals.
Cultural norms between Vietnamese and Indians differ significantly In India, there is a strong emphasis on respecting elders and family, whereas Vietnam places a higher value on individual independence Additionally, while Indians often accept delays in work and appointments, Vietnamese culture prioritizes accuracy and punctuality.
Vietnam and India exhibit distinct ethical and religious values, with India predominantly influenced by Hinduism, Buddhism, and Jainism, while Vietnam is shaped by Buddhism, Taoism, and Confucianism Additionally, the cultural attitudes towards life and animal consumption differ significantly; in India, there is a strong respect for life that discourages the killing of animals, whereas in Vietnam, the consumption of animal products is widely accepted and practiced.
In summary, Vietnam and India have many differences in terms of customs, standards and ethical aspects.
Present the problem to the other side
To effectively collaborate with Indian partners, it is essential to communicate clearly about scheduling and to plan meetings in advance, outlining both the timing and content Given the flexible time culture in India, negotiators should be prepared for potential adjustments before meetings Additionally, incorporating cultural experiences and exchanges can enhance the partnership, ultimately facilitating smoother contract negotiations.
It is possible to suggest that meetings should be conducted in person at the partner's headquarters
This is a convenient location for both parties and has enough conditions to hold negotiations, including internet connection, meeting room, electronic equipment, telephone, computer, projector
Begin with a warm greeting and share essential details about yourself and your organization to help your partner gain a better understanding In India, it is common for individuals to engage in casual conversation before negotiations to gather information Consequently, negotiators should familiarize themselves with popular topics in India to foster rapport and create a harmonious atmosphere prior to entering discussions.
Prior to initiating formal negotiations, it is essential to engage in discussions with the other party regarding the content and objectives of the negotiation This approach ensures that both parties have a clear understanding of the desired outcomes Additionally, thorough preparation of relevant information and an assessment of the partner's status are crucial for fostering agreement and interest in the topics at hand.
Selecting an appropriate time for negotiations is crucial; it is advisable to avoid holidays and significant dates for both parties Additionally, conducting discussions during weekdays and avoiding weekends or nighttime can enhance focus and facilitate more productive conversations.
Solution if the negotiation is not successful
Continue to negotiate: If no agreement is reached in the first negotiation, the parties can continue to negotiate to find a suitable solution to the problems
If direct negotiations fail to yield an agreement, the parties should explore alternative solutions, including arbitration, court dispute resolution, or other settlement methods to effectively resolve their disputes.
Take the issue to a higher level: If face-to-face negotiations fail, the parties can take the issue to a higher level in their organization to find a suitable solution
Re-discuss conditions: In some cases, renegotiating terms can help the parties reach an agreement during the negotiation process
Pausing negotiations: In some cases, pausing negotiations can be a solution to give the parties time to reassess the situation and decide to resume negotiations later
Methods to track resolved issues
There should be a system for recording and tracking the matters discussed to ensure clarity and avoid future misunderstandings or disputes
Mechanism to amend the agreement when necessary
Incorporating an amended clause into the original agreement enables parties to adjust terms in response to changing business conditions or unforeseen circumstances It is essential that this provision is articulated clearly and specifically to prevent any potential misunderstandings regarding the conditions under which amendments can be made.
The parties must establish a fair and transparent process for amending the agreement, ensuring that all stakeholders are involved in the revision process.
Prepare information for the negotiation phase
Summary of points to note in communication with partners
Non-verbal communication in India
When greeting someone, it's best to avoid hugs or kisses unless you are well-acquainted In India, a common greeting involves pressing palms together with fingers facing upward, while handshakes are increasingly popular If you are a man greeting a woman, it's advisable to wait for her to initiate the handshake.
Physical contacts: If you don't know the other person, it is best not to touch them
Bear in mind, though, that if they are the same gender as you, they may touch your arm or hand when speaking
Eye contact: People in India maintain less eye contact than other Western cultures
They keep it minimal, especially between genders and with those in a higher rank than them
Gestures: The nodding gesture where the head is moved up and down, and sometimes diagonally tilted shows approval or understanding
Indians generally adopt a relaxed attitude towards punctuality, prioritizing adaptability over strict adherence to timeframes At social gatherings, it is common for attendees to arrive 30 minutes to an hour late However, in formal settings like business meetings, appointments, or medical visits, punctuality is typically observed.
Negotiations: Negotiations will probably take longer than in other countries They progress partly because they are based on building trust
In indirect communication styles, feedback is delivered subtly and diplomatically, often making it challenging to interpret true sentiments For instance, an Indian speaker may say "yes" to show they are engaged, even if their body language suggests disagreement The term "no" is rarely used, as it can come across as too harsh; instead, phrases like "we'll see" or "yes, but it may be difficult" are preferred to convey reluctance or hesitation.
In India, a common polite response to decline a request is "I'll see what I can do," regardless of the feasibility of the task This cultural nuance is important to recognize, especially for those with a direct communication style, as it may lead to misunderstandings Additionally, avoiding overly direct language is crucial, as it can negatively impact the negotiating environment.
Silence: Sometimes people will remain silent rather than provide a direct 'no'
Small talk: It is rather common for Indians to ask straightforward, personal questions by Western standards, such as asking about salaries, kids, or family plans
In India, it is common for people to ask direct questions, such as inquiries about income, which may seem forward or frank to those from Western cultures.
Emails: Emails tend to include a lot of formalities and are longer than in other countries
In Indian culture, which exhibits a high power distance, power and status are highly valued Consequently, it is essential to send representatives of equal standing to negotiations and to be mindful of the manner in which we address participants.
Respecting your partner's culture is essential, especially in the context of India's rich and diverse heritage Understanding and appreciating Indian dress, manners, and customs can significantly enhance your relationship.
In India, a high-context culture, effective communication relies on understanding nuanced and layered messages It is essential to provide context by explaining your needs and the significance of individual tasks in relation to overall goals, as this clarity fosters better communication and ensures that messages are accurately interpreted.
Investing time in your teams in India through regular team and one-on-one meetings fosters strong relationships and trust This proactive approach enables you to identify and address issues early, preventing them from escalating When trust is established, team members in India will feel more at ease expressing their thoughts directly, eliminating the need for interpretation Consequently, it is essential for our company to embrace their enthusiasm and actively cultivate and sustain positive relationships with our partners.
Establishing a welcoming communication environment enhances professionalism and alleviates stress during negotiations Engaging in light, off-topic conversations can demonstrate genuine interest and showcase a friendly demeanor.
Demonstrating care and respect for your partner is essential; this involves actively listening to and understanding their perspective Engage in honest and serious communication by asking and answering questions thoughtfully.
Clear language is essential in negotiations; it helps convey information effectively and minimizes misunderstandings By using precise words and avoiding unnecessary jargon, you can enhance communication and ensure clarity throughout the process.
To effectively prepare for negotiations, it is essential to familiarize yourself with your partner and the context of the negotiation Understanding their history, culture, political landscape, and economic conditions will provide valuable insights that can enhance your negotiation strategy.
Tentative Agenda
After officially meeting to exchange basic information, the two agreed to conduct a round of negotiations on signing an API business cooperation contract:
Proposed Agenda for Negotiating Rounds with Indian Partners:
May 7, 2023, morning, at meeting room A204
Greet, introduce and exchange information about the company and products
Describe the partnership strategy and its benefits
Discuss the market potential and the economic, political and legal factors affecting business operations
May 12, 2023, afternoon, at meeting room D306
Provide specific solutions to the problem of increasing the cost of the product Evaluate and discuss production capabilities and quality control
May 16, 2023, morning, at meeting room H313
Negotiate the terms of the partnership contract, including distribution, promotion, price, production, and quality
Review payment methods and resolve financial issues
May 21, 2023, morning, at meeting room A102
Adjust and sign cooperation contracts
Make deployment plans, deliver goods and share information
Recommend staff training and support activities, if necessary
Proposed Agenda for a Negotiation with the Indian Partner:
14h-14h15: Welcome and introduce the representatives of the two sides
14:15-15:15: Dialogue to learn about culture, customs, and things to know when working with Indian partners
15:15-15:45: Discuss product and price related issues
16h15-17h: Evaluate and discuss production ability and quality control
17h-17h30: Give specific solutions to the problem of increasing the cost of products 17h30-18h: Summary and goodbye
Note: The program is subject to change depending on the actual negotiation situation.
Draft contract
This Contract was made and entered into by and between:
Company name : Divis Laboratories Ltd
Registered Address : Divi Towers, 1-72/23(P)/DIVIS/303, Cyber Hills, Gachibowli, Hyderabad, Telangana 500032
Legal representative : Nilima Prasad Divi Position : Whole Time Director
Company name : NT Limited Liability Company
Registered Address : 2 Phan Dinh Phung, Hai Chau 1, Hai Chau, Da Nang 550000 Tel : 023654921
Legal representative : Mrs.Phan Thi Huong Tram Position : Procurement Director
The two sides discuss and agree on the following contents:
The following terms, whether used in the singular or plural, shall have the meaning assigned to them below for purposes of this Agreement:
Acquisition Cost refers to the total invoiced price that either Party pays to a Third Party for obtaining Active Pharmaceutical Ingredients, Excipients, or packaging materials This cost encompasses shipping, handling fees, and customs charges incurred during the acquisition process.
2 Active Pharmaceutical Ingredients/API “Active Pharmaceutical Ingredients” or
The term "API" refers to the active pharmaceutical ingredients for the Product detailed in Exhibit 3, which includes the associated specifications and analytical methodologies These specifications may be updated periodically through mutual agreement between the Parties.
An "Affiliate" refers to any entity, whether corporate or non-corporate, that is directly controlled by, controls, or shares common control with a Party A corporate entity is considered to control another if it owns at least fifty percent (50%) of the voting stock In cases where ownership of fifty percent (50%) is not present, control can also be established through the ability to direct the management and policies of the corporation or non-corporate entity.
4 Agreement “Agreement” shall mean this Supply Agreement
The term "Buyer Intellectual Property" refers to any inventions, discoveries, patents, patent applications, technology, know-how, trademarks, information, data, writings, and other forms of property that are supplied to the Seller by or on behalf of the Buyer, or utilized by the Seller in relation to its obligations, and that were owned or licensed by the Buyer before being shared with the Seller.
The Buyer's Regulatory Documentation refers to the documents submitted by the Buyer to regulatory authorities concerning the Product's formulation, along with any supplements filed throughout the duration of this agreement, including the New Drug Application (NDA).
CGMP, or current good manufacturing practices, refers to the standards established by the FDA for the production of pharmaceutical products These practices are defined by FDA regulations, guidelines, and administrative interpretations, which may be updated periodically to ensure compliance and safety in manufacturing processes.
8 Commercial Products “Commercial Product” shall mean Product supplied hereunder intended for commercial sale and/or human use
9 Contract Year: “Contract Year” shall mean the period of twelve (12) successive calendar months commencing on January 1, 2023 and each successive twelve (12) month period thereafter
10 Delivery Date “Delivery Date” shall mean a date for which delivery of Product is stated in a purchase order
"Developments" refers to all inventions, discoveries, know-how, information, data, writings, and other forms of intellectual property, whether tangible or intangible, created by either THE SELLER, THE BUYER, or both during the execution of this Agreement.
12 Development Product “Development Product” shall mean Product not intended for commercial sale
The term "Seller Intellectual Property" refers to all inventions, discoveries, patents, patent applications, technology, know-how, trademarks, information, data, writings, and other forms of property that are provided to the Buyer by or on behalf of the Seller This includes any intellectual property that the Seller owned or was licensed to prior to its provision to the Buyer, and which is utilized by the Buyer in relation to their performance under this agreement.
14 Effective Date “Effective Date” shall mean the date appearing at the beginning of this Agreement
Excipients refer to the raw materials, excluding Active Pharmaceutical Ingredients and packaging, necessary for manufacturing the Product according to the Product Specifications These Excipients are detailed in Exhibit 3, which includes their specifications and related analytical methodologies, subject to updates by mutual agreement between the Parties.
16 FD&C Act “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as amended
17 FDA “FDA” shall mean the United States Food and Drug Administration, or any successor entity
A "Firm Purchase Commitment" refers to the Seller's obligation to supply and the Buyer's obligation to purchase the quantities projected by the Buyer, as outlined in Section 6.3.
19 First Commercial Sale “First Commercial Sale” shall mean the first commercial sale of the Commercial Product by The Buyer or its Affiliates in the Territory following Product Approval
20 Initial Term “Initial Term” shall have the meaning set forth in Section 11.1 hereof
21 Maximum Quantities “Maximum Quantities” shall have the meaning set forth in Section 6.2
22 Minimum Quantities “Minimum Quantities” shall have the meaning set forth in Section 2.2 hereof
23 Monthly Forecast “Monthly Forecast” shall have the meaning set forth in Section 6.2
24 NDA “NDA” shall mean New Drug Application as filed with the FDA
Packaging Specifications refer to the detailed requirements for the packaging and labeling of the Product, which will be included as Exhibit 4 These specifications may be updated periodically through mutual agreement between the Parties.
26 Product “Product” shall mean Capecitabine or Carbidopa as may be mutually agreed upon by the Parties from time to time
27 Product Approval “Product Approval” shall mean final FDA approval of The Buyer's New Drug Application (“NDA”) or other Regulatory Documentation
The term "Product Price" refers to the commercial price of the product specified in Exhibit 1, which is attached and incorporated into this agreement This price may be updated periodically in accordance with the terms outlined in the agreement.
Product Specifications refer to the detailed specifications for the Product, which will be included as Exhibit 5 These specifications are established based on the analytical methodology agreed upon by both Parties and may be updated periodically through mutual agreement This includes any necessary amendments required for Product Approval.
30 Quality Agreement “Quality Agreement” shall mean the Quality Agreement, as further defined in Section 5.6, which shall be significantly in the form of Exhibit 6 hereto
31 Specifications “Specifications” shall mean the Product Specifications and the Packaging Specifications
32 Territory “Territory” shall mean India, and its territories and possessions and Vietnam
33 Third Party “Third Party” shall mean any Party other than The Buyer, The Seller and their respective Affiliates
34 Units “Unit” shall mean a kilogram of Product or such other size as may be mutually agreed upon by the Parties from time to time
Validation Activities refer to the essential tasks that the Seller must complete before the First Commercial Sale These activities encompass process qualification for content uniformity, analytical testing, the preparation of validation technical reports, cleaning validation, and the manufacturing and testing of Validation Lots.
36 Validation Lots “Validation Lots” for a dosage form shall mean shall mean the initial number of Lots, which shall be at least three (3) Lots or such additional
During each Contract Year of this Agreement, the Seller commits to manufacturing and selling Commercial Products to the Buyer, who agrees to purchase them on a non-exclusive basis for sale and distribution within the designated Territory, in accordance with the terms and conditions outlined in this Agreement and its Addendums.